1. business and industrial
2. chemicals industry
3. plastics and polymers

Dossier
Generic Drugs
Galizen
PAGE
1. COMPANY PRESENTATION.
3
2. COMPANY PRODUCTS.
2.1. COMMON GENERIC DRUGS.
5
2.1.1. Generic drugs Details.
6
2.1.2. Generic drugs in bulk Details.
7
Registered generic drugs Data Sheets.
8
2.2. ANTIBIOTICS (CEPHALOSPORINS).
18
2.2.1. Cephalosporins Information.
19
2.2.2. Cephalosporins Details.
22
2.2.3. Cephalosporins in bulk Details.
23
Registered cephalosporins Data Sheets.
24
SUMMARY TABLE.
35
3. CONTACT.
37
2
1. COMPANY PRESENTATION.
Galizen Consulting, S.L. was incorporated in 2012, to trade in manufactured goods
for personal, domestic, industrial and business use.
The company’s core focus surrounds the high demand for import, export, retail and
wholesale of generic drugs, medical supplies and health related products within
international markets.
The company’s goal is to supply a wide range of different customers with high
quality products at competitive prices. Galizen have a variety of customers
including distributors and medical brokers in the health sector, as well as
hospitals, health centers, laboratories and companies engaged in marketing,
manufacturing and distribution of products in the health sector.
Our aim is to offer the best prices with consistent quality, which keeps us on an
ongoing search for products that utilize cutting edge technology and advanced
manufacturing techniques.
The team at Galizen consists of highly qualified industry experts, among them
leading physicians and experts in international trade within the health sector.
3
GENERIC DRUGS
4
2. COMPANY PRODUCTS.
2.1. COMMON GENERIC DRUGS.
Nowadays Galizen has more than 25 common generic drugs in its catalogue, and
can easily supply drugs not listed therein and desired by the client.
The main advantages of the generic drugs within our product range are:
-
WHO-GMP
Certificate
(World
Health
Organization
Good
Manufacturing Practice), which allows sales in Asia, South America
(except Brazil, Colombia and Argentina), C.I.S. Countries and Africa.
-
ISO 9001:2000 Certificate.
-
Packing and quantities tailored to individual customer needs.
-
Leaflets, presentations and texts are available in a variety of languages.
-
Ability to sell generic drugs in bulk.
-
Drugs not listed can be acquired according to customer needs.
-
Galizen have the COPP Certificates for the following drugs (see data sheets
attached):
DICLOFENAC-100 RS.
CIPROFLOXACIN-250 AND CIPROFLOXACIN-500.
DOMPERIDONE-10.
ESOMEPRAZOLE-40.
TRAMADOL-50.
ATORVASTATIN-10 AND ATORVASTATIN-20.
SILDENAFIL CITRATE-100.
If you are interested in purchasing any of the other generic drugs in our catalogue the
estimated time to obtain records and complete formalities to prepare for export is
between 15 and 45 days.
5
2.1.1. GENERIC DRUGS DETAILS.
No.
PRODUCT
COMMERCIAL NAME
PACKING
TOTAL
TABS-CAPS
PACKING DETAIL
MINIMUM
QUANTITY
TABS-CAPS
1 GLUCOSAMINE - 750 Mgr. - CAPS
GLUCOSAMIZEN - 750 Mgr.- CAPSULES
3 x 10
30
BLISTER
500.000
2 GLUCOSAMINE - 1500 Mgr. - TABS
GLUCOSAMIZEN - 1500 Mgr.- TABLETS
3 x 10
30
BLISTER
300.000
3 FOLIC ACID - 5 Mgr.-TABS
ACIFOLIZEN - 5 Mgr.- TABLETS
10 x 10
100
BLISTER
1.500.000
4 DICLOFENAC - 100 SR - CAPS
DICLOFENAZEN 100 SR - CAPSULES
3 x 10
30
BLISTER
500.000
5 AZITHROMYCIN - 250 Mgr. - TABS
AZITROMYZEN - 250 Mgr.- TABLETS
1x6
6
BLISTER
300.000
6 AZITHROMYCIN - 500 Mgr. - TABS
AZITROMYZEN - 500 Mgr.- TABLETS
1x3
3
BLISTER
200.000
7 CIPROFLOXACIN - 250 Mgr. - TABS
CIFLOCZEN - 250 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
8 CIPROFLOXACIN - 500 Mgr. - TABS
CIFLOCZEN - 500 Mgr.- TABLETS
10 x 10
100
BLISTER
500.000
9 DOMPERIDONE - 10 Mgr. - TABS
DOMPERIDOZEN - 10 Mgr.- TABLETS
25 x 10
250
BLISTER
1.500.000
10 ONDANSETRON - 4 Mgr. - TABS
ONDANSETROZEN - 4 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
11 ESOMEPRAZOLE - 40 Mgr. - CAPS
OPRAZOZEN - 40 Mgr.- CAPSULES
10 x 10
100
ALUMINIUM STRIP
12 LORATADINE - 10 Mgr. - TABS
LORATADIZEN - 10 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
13 TRAMADOL - 50 Mgr. - CAPS
TRADOLZEN - 50 Mgr.- CAPSULES
10 x 10
100
BLISTER
1.000.000
14 METRONIDAZOLE - 250 Mgr. - TABS
METRONIDAZEN - 250 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
15 CLOTRIMAZOLE VAGINAL - 100 -TABS
CLOTRIMAZEN VAGINAL 100 - TABLETS
1x6
6
ALUMINIUM STRIP
300.000
16 CLOTRIMAZOLE VAGINAL - 200 -TABS
CLOTRIMAZEN VAGINAL 200 - TABLETS
1x3
3
ALUMINIUM STRIP
200.000
17 AMLODIPINE - 5 Mgr. - TABS
AMLODIPIZEN - 5 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
18 AMLODIPINE - 10 Mgr. - TABS
AMLODIPIZEN - 10 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
19 LOSARTAN - 25 Mgr. - TABS
OSARTAZEN - 25 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
20 LOSARTAN - 50 Mgr. - TABS
OSARTAZEN - 50 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
21 ATENOLOL - 50 Mgr. - TABS
ATENOLOZEN - 50 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
22 ATENOLOL - 100 Mgr. - TABS
ATENOLOZEN - 100 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
23 GLIMEPIRIDE - 1 Mgr. - TABS
GLIMEPIRIZEN - 1 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
24 GLIMEPIRIDE - 2 Mgr. - TABS
GLIMEPIRIZEN - 2 Mgr.- TABLETS
10 x 10
100
BLISTER
1.000.000
25 ATORVASTATIN - 10 Mgr .- TABS
LIPOTOZEN - 10 Mgr.- TABLETS
3 x 10
30
BLISTER
1.000.000
26 ATORVASTATIN - 20 Mgr. - TABS
LIPOTOZEN - 20 Mgr.- TABLETS
3 x 10
30
BLISTER
1.000.000
27 SILDENAFIL CITRATE - 100 - TABS
ZORZAZEN - 100 - TABLETS
1x4
4
BLISTER
400.000
400.000
Drugs highlighted in blue have actually the Certificates of Free Sale (COPP). Obtaining the
COPPs for the rest of drugs or the establishment of a different trade name designated by
the buyer will require between 15 - 45 days.
6
2.1.2. GENERIC DRUGS IN BULK DETAILS.
No.
PRODUCT
PACKING
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
GLUCOSAMINE - 750 Mgr. - CAPS
CETIRIZINE -10 Mgr. - TABS
FOLIC ACID - 5 Mgr. - TABS
DICLOFENAC - 100 SR CAPS
AZITHROMYCIN - 250 Mgr. - TABS
AZITHROMYCIN - 500 Mgr. - TABS
CIPROFLOXACIN - 250 Mgr. - TABS
CIPROFLOXACIN - 500 Mgr. - TABS
DOMPERIDONE - 10 Mgr. - TABS
ONDANSETRON - 4 Mgr. - TABS
ESOMEPRAZOLE - 40 Mgr. - CAPS
LORATADINE - 10 Mgr. - TABS
TRAMADOL - 50 Mgr. - CAPS
OFLOXACIN - 200 Mgr.
OFLOXACIN - 400 Mgr.
LEVOCETIRIZINE - 5 Mgr. - TABS
AMLODIPINE - 5 Mgr. - TABS
AMLODIPINE - 10 Mgr. - TABS
LOSARTAN - 25 Mgr. - TABS
LOSARTAN - 50 Mgr. - TABS
ATENOLOL - 25 Mgr. - TABS
ATENOLOL - 50 Mgr. - TABS
ATENOLOL - 100 Mgr. - TABS
GLIMEPIRIDE - 1 Mgr. - TABS
GLIMEPIRIDE - 2 Mgr. - TABS
ATORVASTATIN - 10 Mgr. - TABS
ATORVASTATIN - 20 Mgr. - TABS
SILDENAFIL CITRATE - 100 Mgr. TABS
PIOGLITAZONE - 15 Mgr. - TABS
PIOGLITAZONE - 30 Mgr. -TABS
TELMISARTAN -20 Mgr. - TABS
TELMISARTAN - 40 Mgr. - TABS
TELMISARTAN - 80 Mgr. - TABS
ROSUVASTATIN - 5 Mgr. - TABS
ROSUVASTATIN - 10 Mgr. - TABS
ROSUVASTATIN - 20 Mgr. - TABS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
1000's - HDPE JARS
MINIMUM ORDER
QUANTITY TABSCAPS
300.000
500.000
1.000.000
300.000
150.000
100.000
500.000
300.000
1.000.000
500.000
300.000
500.000
500.000
300.000
200.000
500.000
500.000
500.000
500.000
500.000
500.000
500.000
500.000
500.000
500.000
500.000
300.000
300.000
300.000
300.000
500.000
500.000
300.000
500.000
300.000
200.000
Drugs highlighted in blue have actually the Certificates of Free Sale (COPP). Obtaining the
COPPs for the rest of drugs or the establishment of a different trade name designated by
the buyer will require between 15 - 45 days.
7
8
Active ingredient and composition:
Each film coated tablet contains:
Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 250 mg.
Excipients: micro crystalline cellulose powder, povidone, magnesium stearate, colloidal anhydrous silica, polacrilin potassium, sodium alginate,
titanium dioxide.
Therapeutic indications:
Lower respiratory tract infections due to Gram-negative bacteria, exacerbations of chronic obstructive pulmonary disease, broncho-pulmonary
infections in cystic fibrosis or in bronchiectasis, pneumonia, chronic suppurative otitis media, acute exacerbation of chronic sinusitis especially if
these are caused by Gram-negative bacteria.
Contraindications:
Hypersensitivity to the active substance, to other quinolones or to any of the excipients. Concomitant administration of Ciprofloxacin and Tizanidine.
Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
In such infections, Ciprofloxacin must be co-administered with other appropriate antibacterial agents. Ciprofloxacin is not recommended for the
treatment of streptococcal infections due to inadequate efficacy.
Presentation:
A white coloured, elongated shaped tablet with score on one side and plain on another side. 10 such tablets packed in blister pack and 10 such
blisters are packed in a carton (100 tablets). Possibility to adapt packing and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Ciprofloxacin 250 mg
CIFLOCZEN-250
9
Active ingredient and composition:
Each film coated tablet contains:
Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 500 mg.
Excipients: micro crystalline cellulose powder, povidone, magnesium stearate, colloidal anhydrous silica, polacrilin potassium, sodium alginate,
titanium dioxide.
Therapeutic indications:
Lower respiratory tract infections due to Gram-negative bacteria, exacerbations of chronic obstructive pulmonary disease, broncho-pulmonary
infections in cystic fibrosis or in bronchiectasis, pneumonia, chronic suppurative otitis media, acute exacerbation of chronic sinusitis especially if
these are caused by Gram-negative bacteria.
Contraindications:
Hypersensitivity to the active substance, to other quinolones or to any of the excipients. Concomitant administration of Ciprofloxacin and Tizanidine.
Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
In such infections, Ciprofloxacin must be co-administered with other appropriate antibacterial agents. Ciprofloxacin is not recommended for the
treatment of streptococcal infections due to inadequate efficacy.
Presentation:
A white coloured, elongated shaped tablet with score on one side and plain on another side. 10 such tablets packed in blister pack and 10 such
blisters are packed in a carton (100 tablets). Possibility to adapt packing and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Ciprofloxacin 500 mg
CIFLOCZEN-500
10
Active ingredient and composition:
Each hard gelatin capsule contains:
Diclofenac Sodium BP 100 mg (As sustained release pellets).
Excipients: ethyl cellulose, hypromellose, mannitol, sucrose, crospovidone, diethyl phthalate.
Therapeutic indications:
Treatment of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis,
painful syndromes of the vertebral column, non-articular rheumatism. Painful post-traumatic and post-operative inflammation and swelling. Primary
dysmenorrhoea.
Contraindications:
Known hypersensitivity to the active substance or to any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation. Last trimester of
pregnancy. Severe hepatic, renal or cardiac failure. Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac Sodium is also
contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
Presentation:
Red/Clear Transparent coloured capsules. 10 tablets are in a blister pack and 3 such packs are in a carton (30 capsules). Possibility to adapt packing
and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Diclofenac 100 mg
DICLOFENAZEN-100SR
11
Active ingredient and composition:
Each uncoated tablet contains:
Domperidone Maleate BP equivalent to Domperidone 10 mg.
Excipients: lactose, di calcium phosphate, starch, micro crystalline cellulose powder, povidone, magnesium stearate, colloidal anhydrous silica,
sodium starch glycolate, talc, croscarmellose sodium, tartrazine.
Therapeutic indications:
The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents.
Contraindications:
Known hypersensitivity to Domperidone or any of the excipients, prolactin-releasing pituitary tumour (prolactinoma). Domperidone should not be
used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation. This medication
should be used only if clearly needed during pregnancy. Domperidone passes into breast milk. Due to the potential risks to a nursing infant, breastfeeding while using this drug is not recommended.
Presentation:
A white coloured, round shaped, scored on one side and plain on other side tablets. 10 tablets are packed in a blister pack, 25 such blisters are packed
in a carton (250 tablets). Possibility to adapt packing and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Domperidone 10 mg
DOMPERIDOZEN-10
12
Active ingredient and composition:
Each film coated tablet contains:
Atorvastatin Calcium USP equivalent to Atorvastatin 10 mg.
Excipients: lactose, starch, povidone, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, hydroxy methyl propyl cellulose, red
oxide of iron.
Therapeutic indications:
Reduce the risk of myocard infarction. Reduce the risk of stroke. Reduce the risk for revascularization procedures and angina. Hyperlipidemia.
Contraindications:
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. Hypersensitivity to any of the components.
Pregnancy & Lactation.
Presentation:
A red coloured, round tablet. 10 tablets are packed in a blister pack, 3 such blisters are in a carton (30 tablets). Possibility to adapt packing and
quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Atorvastatin 10 mg
LIPOTOZEN-10
13
Active ingredient and composition:
Each film coated tablet contains:
Atorvastatin Calcium USP equivalent to Atorvastatin 20 mg.
Excipients: lactose, starch, povidone, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, hydroxy methyl propyl cellulose, yellow
oxide of iron.
Therapeutic indications:
Reduce the risk of myocardial infarction. Reduce the risk of stroke. Reduce the risk for revascularization procedures and angina. Hyperlipidemia.
Contraindications:
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. Hypersensitivity to any of the components.
Pregnancy & Lactation.
Presentation:
A yellow coloured, round tablet. 10 tablets are packed in a blister pack, 3 such blisters are in a carton (30 tablets). Possibility to adapt packing and
quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Atorvastatin 20 mg
LIPOTOZEN-20
14
Active ingredient and composition:
Each hard gelatin capsule contains:
Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg.
Excipients: hypromellose, mannitol, sucrose, crospovidone, hypromellose phthalate, diethyl phthalate.
Therapeutic indications:
Gastroesophageal Reflux Disease (GERD), treatment of erosive reflux esophagitis, healing of Helicobacter pylori associated duodenal ulcer,
prevention and healing of gastric and duodenal ulcers associated with NSAID therapy, prolonged treatment after i.v. induced prevention of
rebleeding of peptic ulcers, treatment of Zollinger Ellison Syndrome.
Contraindications:
Known hypersensitivity to Esomeprazole, substituted benzimidazoles or any other constituents of the formulation. Esomeprazole like other PPIs
should not be administered with Atazanavir.
Presentation:
Red/Peach coloured capsules. 10 capsules are packed in an aluminium strip pack, 10 such strips are packed in a carton (100 capsules). Possibility to
adapt packing and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Esomeprazole 40 mg
OPRAZOZEN-40
15
Active ingredient and composition:
Each hard gelatin capsule contains:
Tramadol Hydrochloride BP 50 mg.
Excipients: micro crystalline cellulose powder, povidone, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium.
Therapeutic indications:
The treatment of moderate to severe pain.
Contraindications:
Hypersensitivity to Tramadol or any excipients in the capsules. In acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic
medicinal products. In patients receiving MAO-inhibitors, or within 2 weeks of their withdrawal. In patients who are suffering from uncontrolled
epilepsy. Tradolzen-50 capsules must not be used for narcotic withdrawal treatment.
Presentation:
Green/Yellow coloured capsules. 10 capsules are packed in a blister pack and 10 such blisters are packed in a carton (100 capsules). Possibility to
adapt packing and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Tramadol 50 mg
TRADOLZEN-50
16
Active ingredient and composition:
Each film coated tablet contains:
Sildenafil Citrate equivalent to Sildenafil 100 mg.
Excipients: lactose, di calcium phosphate, starch, micro crystalline cellulose powder, povidone, sodium lauryl sulphate, magnesium stearate, colloidal
anhydrous silica, sodium starch glycolate, talc, croscarmellose sodium, hydroxy methyl propyl cellulose, indigo carmine.
Therapeutic indications:
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual
performance. In order for ZORZAZEN-100 to be effective, sexual stimulation is required.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Consistent with its known effects on the nitric oxide/cyclic guanosine
monophosphate (cGMP) pathway, Sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide
donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated. Agents for the treatment of erectile dysfunction, including
Sildenafil, should not be used in men for whom sexual activity is inadvisable. ZORZAZEN-100 is contraindicated in patients who have loss of vision in
one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with
previous PDE5 inhibitor exposure.
Presentation:
Blue coloured, diamond shaped, film coated tablets in blister pack of 4 tablets and 1 such pack in a carton box (4 tablets). Possibility to adapt packing
and quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Sildenafil Citrate 100 mg
ZORZAZEN-100
CEPHALOSPORINS
17
2.2. CEPHALOSPORINS.
Nowadays Galizen has 47 cephalosporins in its catalogue, and can easily supply
cephalosporins not listed therein and desired by the client.
The main advantages of the cephalosporins within our product range are:
-
WHO-GMP Certificate (World Health Organization Good Manufacturing
Practice), which allows sales in Asia, South America (except Brazil, Colombia and
Argentina), C.I.S. Countries and Africa. Cephalosporins will be soon UE-GMP Certified
(European Union Good Manufacturing Practice) for free sales in EU (except United
Kingdom).
-
ISO 14001:2004 Certificate.
-
BS OHSAS 18001:2007 Certificate.
-
Packing and quantities tailored to individual customer needs.
-
Leaflets, presentations and texts are available in a variety of languages.
-
Ability to sell cephalosporins in bulk.
-
Drugs not listed can be acquired according to customer needs.
-
Galizen have the COPP Certificates for the following cephalosporins (see data
sheets attached):
CEFUROXIME SODIUM FOR INJECTION 750 mg.
CEFOTAXIME SODIUM FOR INJECTION 1000 mg.
CEFAZOLIN SODIUM FOR INJECTION 1000 mg.
CEFTIZOXIME FOR INJECTION 1000 mg.
CEFEPIME FOR INJECTION 1000 mg.
CEPHALEXIN CAPSULES 500 mg.
CEFADROXIL CAPSULES 500 mg.
CEFACLOR CAPSULES 250 mg.
CEPHALEXIN ORAL SUSPENSION 125mg/5ml (30ml bottle).
CEPHALEXIN ORAL SUSPENSION 125mg/5ml (100ml bottle).
CEFUROXIME AXETIL ORAL SUSPENSION 125mg/5ml (30ml bottle).
If you are interested in purchasing any of the other cephalosporins in our catalogue the
estimated time to obtain records and complete formalities to prepare for export is
between 15 and 45 days.
18
2.2.1. CEPHALOSPORINS INFORMATION.
Definition:
Cephalosporins are a class of beta-lactam antibiotics. Along with cephamycins belong to
a subgroup called the cefamos. Cephalosporins are similar to penicillins, but more stable
against many bacterial β-lactamases and, therefore, have a broader spectrum of activity.
Mechanism of action:
Cephalosporins act in the same way as the penicillins: by interfering with the synthesis
of peptidoglycan of the bacterial cell wall and inhibits the end transpeptidation
necessary for crosslinking. This generates a bacteriolytic effect.
Cephalosporins are broad-spectrum antibiotic used in the treatment of septicemia,
pneumonia, meningitis, biliary tract infections, peritonitis and urinary tract infections.
Cephalosporins pharmacology resembles that of penicillins and its excretion is
fundamentally renal. Cephalosporins penetrate the cerebrospinal fluid poorly unless the
meninges are inflamed; cefotaxima is a cephalosporin appropriate to treat CNS
infections (e.g. meningitis).
Cefuroxime is a "second-generation" cephalosporin, less sensitive than first
cephalosporins to inactivation by β-lactamases. So, it is active against certain bacteria
with resistance to other drugs and has greater activity against Haemophilus influenzae
and Neisseria gonorrhoeae.
Cefotaxime, ceftazidime and ceftriaxone are a "third generation" cephalosporins with
more activity than the "second generation" against certain gram-negative bacteria.
However, they show less effect than cefuroxime against gram-positive bacteria,
specifically Staphylococcus aureus.
Its broad antibacterial spectrum can encourage bacterial or fungal superinfections
resistant.
Ceftazidime provides a satisfactory activity against pseudomonas. It also has activity
against other gram-negative bacteria.
19
Ceftriaxone has a longer half-life and need to be administered only once a day. Its
indications include severe infections, the type of septicemia, pneumonia or meningitis.
The calcium salt of ceftriaxone form a precipitate in the gallbladder that rarely produces
symptoms, although they usually refer once the antibiotic is discontinued.
The cefpirome is authorized for urinary tract infections, lower respiratory and skin,
bacteremia and infections associated with neutropenia.
Classification:
Cephalosporins are grouped into groups called "generations" by their antimicrobial
properties. The first cephalosporins were grouped into the "first generation" while later
extended
spectrum
cephalosporins
were
classified
as
second-generation
cephalosporins. Each new generation of cephalosporins has more potency against gramnegative bacteria, significantly greater antimicrobial properties than the preceding
generation; currently exists four different generations of cephalosporins. Note that firstgeneration cephalosporins have greater spectrum of activity against staphylococcus and
streptococcus than recent generations.
Side Effects:
The main side effect of cephalosporins is hypersensitivity and about 10% of patients
sensitive to penicillin also manifest allergy to cephalosporins.
20
Cephalosporins with oral administration activity:
“First Generation” cephalosporins with oral administration activity such as cephalexin,
cephradine and cefadroxil, and “Second Generation” Cephalosporins such as cefaclor
and cefprozil, show a similar antimicrobial spectrum. They are used in urinary tract
infections that do not respond to other medicines or that occur during pregnancy, as
well as respiratory infections, otitis media, sinusitis and infections of the skin and soft
tissues. The cefaclor has good activity against H. influenzae, but is associated with
prolonged skin reactions, especially in children. Cefadroxil is long acting and can be
given twice daily. It has very little activity against H. influenzae. Cefuroxime axetil is a
“second generation” Cephalosporin ester of cefuroxime, has the same antibacterial effect
than the parent compound and is poorly absorbed.
Cefixime is longer than other cephalosporins with oral administration activity and is
just permitted only for acute infections.
Cefpodoxime proxetil has more activity than other oral cephalosporins against
respiratory bacterial pathogens and is authorized in the upper and lower respiratory
infections.
21
2.2.2. CEPHALOSPORINS DETAILS.
No.
CEPHALOSPORINS
COMMERCIAL NAME
001
002
003
004
005
006
007
008
009
010
011
012
013
014
015
016
017
018
019
020
021
022
023
024
025
CEFUROXIME SODIUM FOR INJECTION 750mg
CEFUROXIME SODIUM FOR INJECTION 750mg + WFI
CEFUROXIME SODIUM FOR INJECTION 1500mg
CEFUROXIME SODIUM FOR INJECTION 1500mg + WFI
CEFTRIAXONE SODIUM FOR INJECTION 1000mg
CEFTRIAXONE SODIUM FOR INJECTION 1000mg + WFI
CEFOTAXIME SODIUM FOR INJECTION 1000mg
CEFOTAXIME SODIUM FOR INJECTION 1000mg + WFI
CEFAZOLIN SODIUM FOR INJECTION 1000mg
CEFAZOLIN SODIUM FOR INJECTION 1000mg + WFI
CEFTIZOXIME FOR INJECTION 1000mg
CEFTIZOXIME FOR INJECTION 1000mg + WFI
CEFTAZIDIME INJECTION 1000mg
CEFTAZIDIME INJECTION 1000mg + WFI
CEFOPERAZONE FOR INJECTION 1000mg
CEFOPERAZONE FOR INJECTION 1000mg + WFI
CEFPIROME FOR INJECTION 1000mg
CEFPIROME FOR INJECTION 1000mg + WFI
CEFEPIME FOR INJECTION 1000mg
CEFEPIME FOR INJECTION 1000mg + WFI
CEFTRIAXONE AND TAZOBACTAM FOR INJECTION 1000 + 125mg
CEFTRIAXONE AND SULBACTAM FOR INJECTION 1000 + 500mg
CEFOPERAZONE AND SULBACTAM FOR INJECTION 500 + 500mg
CEFOPERAZONE AND SULBACTAM FOR INJECTION 1000 + 1000mg
CEFTRIAXONE AND SULBACTAM FOR INJECTION 250 + 125mg
MINIMUM
QUANTITY
PACKING
TOTAL
USP type III
10ml vial
with product
insert in a
250 GSM
monocarton;
50 such
monocartons
in a plain
white eflute
box with
sticker label;
8 such boxes
in a 5 ply
corrugated
brown
master
carton
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
BLISTER
BLISTER
BLISTER
BLISTER
BLISTER
BLISTER
BLISTER
100
100
100
100
10
10
100
BLISTER
BLISTER
BLISTER
BLISTER
BLISTER
BLISTER
10
10
10
10
10
10
200.000
200.000
200.000
200.000
200.000
200.000
BOTTLE
BOTTLE
BOTTLE
BOTTLE
BOTTLE
BOTTLE
BOTTLE
30 Ml.
30 Ml.
30 Ml.
30 Ml.
30 Ml.
100 Ml.
30 Ml.
15.000
15.000
15.000
15.000
15.000
15.000
15.000
SACHETS
SACHETS
10
10
200.000
200.000
DRY POWDER FOR INJECTION (+/- water for injection WFI)
CEFUROXIZEN SODIUM FOR INJECTION 750 mg
CEFUROXIZEN SODIUM FOR INJECTION 750 mg +WFI
CEFUROXIZEN SODIUM FOR INJECTION 1500 mg
CEFUROXIZEN SODIUM FOR INJECTION 1500 mg +WFI
CEFTRIZEN SODIUM FOR INJECTION 1000 mg
CEFTRIZEN SODIUM FOR INJECTION 1000 mg + WFI
CEFOTAZEN SODIUM FOR INJECTION 1000 mg
CEFOTAZEN SODIUM FOR INJECTION 1000 mg + WFI
CEFAZOZEN SODIUM FOR INJECTION 1000 mg
CEFAZOZEN SODIUM FOR INJECTION 1000 mg + WFI
ZOXIZEN FOR INJECTION 1000 mg
ZOXIZEN FOR INJECTION 1000 mg + WFI
TAZIDIZEN INJECTION 1000 mg
TAZIDIZEN INJECTION 1000 mg WFI
PERAZOZEN FOR INJECTION 1000 mg
PERAZOZEN FOR INJECTION 1000 mg + WFI
CEFPIROZEN FOR INJECTION 1000 mg
CEFPIROZEN FOR INJECTION 1000 mg + WFI
CEFEPIZEN FOR INJECTION 1000 mg
CEFEPIZEN FOR INJECTION 1000 mg + WFI
ZOSIZEN FOR INJECTION 1000 + 125 mg
TRIAXULZEN FOR INJECTION 1000 + 500 mg
PERSULZEN FOR INJECTION 500 + 500 mg
PERSULZEN FOR INJECTION 1000 + 1000 mg
TRIAXULZEN FOR INJECTION 250 + 125 mg
60.000
60.000
42.000
42.000
58.500
58.500
63.000
63.000
63.000
63.000
52.000
52.000
53.000
53.000
60.000
60.000
47.000
47.000
40.500
40.500
33.000
51.000
52.000
35.000
68.000
CAPSULES
101
102
103
104
105
106
107
CEPHALEXIN CAPSULES 500mg
CEFADROXIL CAPSULES 500mg
CEFDINIR CAPSULES 300mg
CEFACLOR CAPSULES 250mg
CEFPODOXIME PROXETIL CAPSULES 100mg
CEFPODOXIME PROXETIL CAPSULES 200mg
CEPHRADINE CAPSULES 250mg
CEPHALEXIZEN CAPSULES 500 mg
CEFADROXIZEN CAPSULES 500 mg
CEFDIZEN CAPSULES 300 mg
CEFACLOZEN CAPSULES 250 mg
CEFOTAXIZEN PROXETIL CAPSULES 100 mg
CEFOTAXIZEN PROXETIL CAPSULES 200 mg
CEFRADIZEN CAPSULES 250 mg
201
202
203
204
205
206
CEFPODOXIME PROXETIL TABLETS 100mg
CEFPODOXIME PROXETIL TABLETS 200mg
CEFUROXIME AXETIL TABLETS 250mg
CEFUROXIME AXETIL TABLETS 500mg
CEFIXIME TABLETS 100mg
CEFIXIME TABLETS 200mg
CEFOTAXIZEN PROXETIL TABLETS 100 mg
CEFOTAXIZEN PROXETIL TABLETS 200 mg
CEFUROXIZEN AX TABLETS 250 mg
CEFUROXIZEN AX TABLETS 500 mg
CEFIXIZEN TABLETS 100 mg
CEFIXIZEN TABLETS 200 mg
301
302
303
304
305
306
307
CEFDINIR ORAL SUSPENSION 125mg/5ml ( 30ml )
CEPHALEXIN ORAL SUSPENSION 125mg/5ml ( 30ml )
CEFIXIME ORAL SUSPENSION 50mg/5ml ( 30 ml )
CEFPODOXIME PROXETIL ORAL SUSPENSION 50mg/5ml ( 30ml)
CEFUROXIME AXETIL ORAL SUSPENSION 125mg/5 ml ( 30ml)
CEPHALEXIN ORAL SUSPENSION 125mg/5ml ( 100ml )
CEFIXIME ORAL SUSPENSION100 mg/5ml ( 30ml )
CEFDIZEN ORAL SUSPENSION 125mg/5ml (30ml )
CEPHALEXIZEN ORAL SUSPENSION 125mg/5ml (30ml )
CEFIXIZEN ORAL SUSPENSION 50mg/5ml (30ml )
CEFOTAXIZEN PROXETIL ORAL SUSPENSION 50mg/5ml (30ml)
CEFUROXIZEN AX ORAL SUSPENSION 125mg/5ml (30ml)
CEPHALEXIZEN ORAL SUSPENSION 125mg/5ml (100ml )
CEFIXIZEN ORAL SUSPENSION 100mg/5ml (30ml )
1.000.000
1.000.000
300.000
300.000
300.000
300.000
300.000
TABLETS
ORAL SUSPENSION
SACHETS
401 CEFIXIME FOR ORAL SUSPENSION 100mg/ sachet
402 CEPHALEXIN FOR ORAL SUSPENSION 125mg/sachet
CEFIXIZEN FOR ORAL SUSPENSION 100 mg/sachet
CEPHALEXIZEN FOR ORAL SUSPENSION 125 mg/sachet
Cephalosporins highlighted in blue have actually the Certificates of Free Sale (COPP).
Obtaining the COPPs for the rest of drugs or the establishment of a different trade name
designated by the buyer will require between 15 - 45 days.
22
2.2.3. CEPHALOSPORINS IN BULK DETAILS.
No.
CEPHALOSPORINS
COMMERCIAL NAME
TOTAL
MINIMUM
QUANTITY
DRY POWDER FOR INJECTION (+/- water for injection WFI)
001
007
009
011
019
CEFUROXIME SODIUM FOR INJECTION 750mg
CEFOTAXIME SODIUM FOR INJECTION 1000mg
CEFAZOLIN SODIUM FOR INJECTION 1000mg
CEFTIZOXIME FOR INJECTION 1000mg
CEFEPIME FOR INJECTION 1000mg
CEFUROXIZEN SODIUM FOR INJECTION 750 mg
CEFOTAZEN SODIUM FOR INJECTION 1000 mg
CEFAZOZEN SODIUM FOR INJECTION 1000 mg
ZOXIZEN FOR INJECTION 1000 mg
CEFEPIZEN FOR INJECTION 1000 mg
1
1
1
1
1
60.000
63.000
63.000
52.000
40.500
CAPSULES
101 CEPHALEXIN CAPSULES 500mg
102 CEFADROXIL CAPSULES 500mg
104 CEFACLOR CAPSULES 250mg
CEPHALEXIZEN CAPSULES 500 mg
CEFADROXIZEN CAPSULES 500 mg
CEFACLOZEN CAPSULES 250 mg
100
100
100
1.000.000
1.000.000
300.000
ORAL SUSPENSION
302 CEPHALEXIN ORAL SUSPENSION 125mg/5ml ( 30ml )
CEPHALEXIZEN ORAL SUSPENSION 125 mg/5 ml (30 ml )
30 Ml.
305 CEFUROXIME AXETIL ORAL SUSPENSION 125mg/5 ml ( 30ml) CEFUROXIZEN AX ORAL SUSPENSION 125 mg/5 ml (30 ml) 30 Ml.
306 CEPHALEXIN ORAL SUSPENSION 125mg/5ml ( 100ml )
CEPHALEXIZEN ORAL SUSPENSION 125 mg/5 ml (100 ml ) 100 Ml.
20.000
20.000
20.000
The estimated production time for the first order in bulk is 35-50 days. Subsequently
each order would be manufactured in an estimated time of 21 days.
Cephalosporins in bulk (capsules and tablets) are packaged in HDPE bottles of 1000. Dry
syrups and injections are packaged in the same format as mentioned in 4.2.2.
In case you are interested in knowing the prices of other cephalosporins in bulk of the
catalogue please request them.
23
24
Active ingredient and composition:
Each hard gelatin capsule contains:
Cefaclor USP equivalent to Anhydrous Cefaclor 250 mg.
Excipients: lactose anhydrous, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate.
Indications:
CEFACLOZEN is indicated in the treatment of the following infections when caused by susceptible strains of micro-organisms: lower respiratory
infections, acute bronchitis, and acute exacerbations of chronic bronchitis, upper respiratory infections, including pharyngitis and tonsillitis (Note:
penicillin is the usual medicine of choice in the treatment and prevention of streptococcal), infections, including the prophylaxis of rheumatic fever,
otitis media, skin and soft-tissue infections, urinary tract infections (Note: Cefaclor has been found to be effective in both acute and chronic urinary
tract infections),skin and skin structure infections, sinusitis.
Contraindications:
CEFACLOZEN is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Presentation:
CEFACLOZEN Capsules is available as 250 mg Cefaclor capsules in blister packs of 10´s (100 capsules). Possibility to adapt packing and quantities to
customer needs.
Administration:
For oral administration.
Packaging Design:
Cefaclor 250 mg – Second Generation
CEFACLOZEN-250
25
Active ingredient and composition:
Each hard gelatin capsule contains:
Cefadroxil USP equivalent to Anhydrous Cefadroxil 500 mg.
Excipients: lactose anhydrous, croscarmellose sodium, magnesium stearate.
Indications:
Treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: urinary tract infections
caused by E. Coli, P. Mirabilis and Klebsiella species, skin and skin structure infections caused by staphylococci and/or streptococci, pharyngitis
and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Cefadroxil monohydrate is generally effective in the
eradication of streptococci from the oropharynx. To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Cefadroxizen-500 capsules and other antibacterial drugs, Cefadroxizen Capsules should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria.
Contraindications:
CEFADROXIZEN-500 is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Presentation:
CEFADROXIZEN-500 Capsules is available as 500 mg Cefadroxil capsules in blister packs of 10´s (100 capsules). Possibility to adapt packing and
quantities to customer needs.
Administration:
For oral administration.
Packaging Design:
Cefadroxil 500 mg – First Generation
CEFADROXIZEN-500
26
Active ingredient and composition:
Each vial contains:
Sterile Cefazolin Sodium USP equivalent to Anhydrous Cefazolin 1000 mg.
Indications:
For the treatment of the following infections due to susceptible organisms: respiratory tract infections, urinary tract infections, skin and skin
structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, endocarditis. Perioperative Prophylaxis: The
prophylactic administration of Cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative
infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g. vaginal hysterectomy,
and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile
stones). The perioperative use of Cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious
risk (e.g. during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin should usually be discontinued within
a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g. open-heart surgery
and prosthetic arthroplasty), the prophylactic administration of Cefazolin may be continued for 3 to 5 days following the completion of surgery.
Contraindications:
CEFAZOZEN-1000 and dextrose injection USP (Cefazolin and dextrose for injection) is contraindicated in patients who have known allergy to the
cephalosporins group of antibiotics. Solution containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Presentation:
1000 mg vials of Cefazolin (as Cefazolin Sodium). Possibility to adapt packing and quantities to customer needs.
Administration:
For intramuscular or intravenous administration.
Packaging Design:
Cefazolin 1000 mg – First Generation
CEFAZOZEN-1000
27
Active ingredient and composition:
Each vial contains:
Sterile Cefepime Hydrochloride USP equivalent to Anhydrous Cefepime 1000 mg.
Indications:
Pneumonia, empiric therapy for febrile neutropenic patients, uncomplicated and complicated urinary tract infections (including pyelonephritis),
uncomplicated skin and skin structure infections, complicated intra-abdominal infections (used in combination with metronidazole), septicaemia.
Contraindications:
CEFEPIZEN-1000 is contraindicated in patients who have shown immediate hypersensitivity reactions to Cefepime or the cephalosporin class of
antibiotics, penicillins or other beta-lactam antibiotics. In case of impaired hepatic function and impaired hypertension. Pregnancy and lactation:
safety of use in pregnancy and lactation has not been established.
Presentation:
1000 mg vials of Cefepime. Possibility to adapt packing and quantities to customer needs.
Administration:
For intramuscular or intravenous administration.
Packaging Design:
Cefepime 1000 mg – Fourth Generation
CEFEPIZEN-1000
28
Active ingredient and composition:
Each vial contains:
Sterile Cefotaxime Sodium USP equivalent to Anhydrous Cefotaxime 1000 mg.
Indications:
Used in the treatment of severe infections caused by Cefotaxime-sensitive pathogens such as: infections of the respiratory tract, including throat and
nose, infections of the ear, kidneys and urinary tract infections, skin and soft tissue infections, conditions of the bones and joints, infections in the
genital organs and abdominal region, septicaemia, bacterial endocarditis & meningitis. For preoperative prophylaxis in patients who are at increased
risk from infection and for the prophylaxis of infections in patients with reduced resistance. Combined treatment: in severe, life-threatening
infections, the combination of Cefotaxime Sodium with aminoglycosides is indicated without awaiting the results of sensitivity tests. The two
preparations must be administered separately, not mixed in one syringe of infusion bottle. Infections with Pseudomonas aeruginosa may require
treatment with other antibiotics effective against Pseudomonas.
Contraindications:
CEFOTAZEN-1000 is contraindicated in patients who have shown hypersensitivity to cephalosporins. In patiens hypersensitive to penicillin, the
possibility of cross-sensitivity exists. Renal function must be checked in case of use of a combination of CEFOTAZEN with aminoglycosides.
Presentation:
1000 mg vials of Cefotaxime (as Cefotaxime Sodium). Possibility to adapt packing and quantities to customer needs.
Administration:
For intramuscular or intravenous administration.
Packaging Design:
Cefotaxime 1000 mg – Third Generation
CEFOTAZEN-1000
29
Active ingredient and composition:
Each 5 ml of the reconstituted suspension contains:
Cefuroxime Axetil USP equivalent to Anhydrous Cefuroxime 125 mg.
Excipients: betacyclodextrin, purified water, isopropyl alcohol, sucrose, xanthan gum, aspartame, acesulfame–K Pharma D, purified talc, tutti frutti
premium flavour.
Indications:
CEFUROXIZEN DS powder for oral suspension is indicated for the treatment of pediatric patients from 3 months to 12 years of age with mild to
moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Pharyngitis/Tonsillitis: the usual
drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the
intramuscular route. CEFUROXIZEN DS powder for oral suspension is generally effective in the eradication of streptococci from the nasopharynx.
Acute bacterial otitis media. Impetigo.
Contraindications:
CEFUROXIZEN-DS is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Presentation:
CEFUROXIZEN-DS is available as 125mg / 5ml Cefuroxime oral suspension (as Cefuroxime Axetil) in 30ml bottles. Possibility to adapt packing and
quantities to customer needs.
Administration:
Oral Suspension.
Packaging Design:
Cefuroxime 125 mg – Second Generation
CEFUROXIZEN-DS 125 (30ml)
30
Active ingredient and composition:
Each vial contains:
Sterile Cefuroxime Sodium USP equivalent to Anhydrous Cefuroxime 750 mg.
Indications:
For the treatment of following conditions caused by susceptible organisms: lower respiratory tract infections, including pneumonia, urinary tract
infections, skin and skin-structure infections, septicemia, meningitis, gonorrhea, bone and joint infections caused by Staphylococcus.
Contraindications:
CEFUROXIZEN-750 is contraindicated in patients who have known allergy to the cephalosporins group of antibiotics.
Presentation:
750 mg vials of Cefuroxime (as Cefuroxime Sodium). Possibility to adapt packing and quantities to customer needs.
Administration:
For intramuscular or intravenous administration.
Packaging Design:
Cefuroxime 750 mg – Second Generation
CEFUROXIZEN-750
31
Active ingredient and composition:
Each 5 ml of the reconstituted suspension contains:
Cephalexin Monohydrate USP equivalent to Anhydrous Cephalexin 125 mg.
Excipients: sucrose, xanthan gum, colloidal silicon dioxide, cherry premium flavour, erythrosine lake.
Indications:
Bacterial sinusitis, respiratory tract infections caused, otitis media, skin and skin-structure infections, bone infections, genitourinary tract infections,
including acute prostatitis, dental infections caused by staphylococci and/or streptococci.
Contraindications:
CEPHALEXIZEN-DS is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Presentation:
CEPHALEXIZEN-DS is available as 125mg / 5ml Cephalexin oral suspension (as Cephalexin/Cephalexin monohydrate) in 30ml/100ml. Possibility to
adapt packing and quantities to customer needs.
Administration:
Oral Suspension.
Packaging Design:
Cephalexin 125 mg – First Generation
CEPHALEXIZEN-DS 125 (30ml)
32
Active ingredient and composition:
Each 5 ml of the reconstituted suspension contains:
Cephalexin Monohydrate USP equivalent to Anhydrous Cephalexin 125 mg.
Excipients: sucrose, xanthan gum, colloidal silicon dioxide, cherry premium flavour, erythrosine lake.
Indications:
Bacterial sinusitis, respiratory tract infections caused, otitis media, skin and skin-structure infections, bone infections, genitourinary tract infections,
including acute prostatitis, dental infections caused by staphylococci and/or streptococci.
Contraindications:
CEPHALEXIZEN-DS is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Presentation:
CEPHALEXIZEN-DS is available as 125mg / 5ml Cephalexin oral suspension (as Cephalexin/Cephalexin monohydrate) in 30ml/100ml. Possibility to
adapt packing and the quantities to customer needs.
Administration:
Oral Suspension.
Packaging Design:
Cephalexin 125 mg – First Generation
CEPHALEXIZEN-DS 125 (100ml)
33
Active ingredient and composition:
Each hard gelatin capsule contains:
Cephalexin USP equivalent to Anhydrous Cephalexin 500 mg.
Excipients: lactose anhydrous, croscarmellose sodium, magnesium stearate.
Indications:
CEPHALEXIZEN can be used for the relief of following conditions when caused by susceptible strains: bacterial sinusitis, respiratory tract infections,
otitis media, skin and skin-structure infections, bone infections, genitourinary tract infections and dental infections.
Contraindications:
Patients with known allergy to the cephalosporin group of antibiotics. Stomach upset, headache, fatigue, dizziness, or diarrhoea may occur. In case of
symptoms like mental/mood changes, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, new signs of
infection (e.g., persistent sore throat or fever), easy bruising/bleeding or change in the amount of urine , advice should be sought from a Doctor. This
medication may rarely cause pseudomembranous colitis due to resistant bacteria while receiving therapy or even weeks after treatment has stopped.
Do not use anti-diarrhoeal or narcotic pain medications if symptoms like persistent diarrhoea, abdominal or stomach pain/cramping, or
blood/mucus in stool are present because they may worsen the condition. Use of this medication for prolonged or repeated periods may result in
oral thrush or a vaginal yeast infection. Contact a doctor if white patches in mouth, a change in vaginal discharge or other similar symptoms are
noted. A serious allergic reaction to this drug is unlikely, but in case of such an occurance immediate medical attention should be sought. Symptoms
of a serious allergic reaction include: rash, itching, swelling, severe dizziness and breathing trouble. If other effects not listed above are noticed,
contact a doctor or pharmacist.
Presentation:
CEPHALEXIZEN-500 Capsules is available as 500 mg Cephalexin capsules in blister packs of 10´s (100 capsules). Possibility to adapt packing and the
quantities to customer needs.
Administration:
Oral administration.
Packaging Design:
Cephalexin 500 mg – First Generation
CEPHALEXIZEN-500
34
Active ingredient and composition:
Each vial contains:
Sterile Ceftizoxime Sodium USP equivalent to Anhydrous Ceftizoxime 1000 mg.
Indications:
ZOXIZEN is indicated in the treatment of infections due to susceptible strains of the microorganisms: lower respiratory tract infections, urinary tract
infections, pelvic inflammatory disease, intra-abdominal infections, septicemia, skin and skin structure infections, bone and joint infections,
meningitis
Contraindications:
ZOXIZEN is contraindicated in patients who have known allergy to the drug. In clinical experience to date, no disulfiram-like reactions have been
reported with ZOXIZEN.
Presentation:
1000 mg vials of Cetizoxime (as Ceftizoxime Sodium). Possibility to adapt packing and the quantities to customer needs.
Administration:
For intramuscular or intravenous administration.
Packaging Design:
Ceftizoxime 1000 mg – Third Generation
ZOXIZEN-1000
TO BE DEFINED
TO BE DEFINED
TO BE DEFINED
TO BE DEFINED
TO BE DEFINED
OFLOXACIN
LEVOCETIRIZINE
PIOGLITAZONE
TELMISARTAN
ROSUVASTATIN
LIPOTOZEN
ATORVASTATIN
ZORZAZEN
GLIMEPIRIZEN
GLIMEPIRIDE
TO BE DEFINED
ATENOLOZEN
ATENOLOL
CETIRIZINE
OSARTAZEN
LOSARTAN
SILDENAFIL
CITRATE
AMLOPIDIZEN
AMLOPIDINE
Treatment of single or mixed vaginal infection. Oral coadjuvant treatment of trichomoniasis. Treatment of candidiasic balanitis.
Urethritis and trichomonas vaginalis. Lambliasis. Intestinal and hepatic amoebiasis. Infection by anaerobic bacterias: bacteroides, fusobacterium, eubacteria, clostridium, anaerobic streptococci. Prevention of postoperative infection by anaerobic
bacterias, especially bacteroides and streptococci. Warning: It should be administered during meals.
The treatment of moderate to severe pain.
Symptomatic and temporary relief of allergic processes due to pollen, pets, dust or other agents. Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Gastroesophageal Reflux Disease (GERD), treatment of erosive reflux esophagitis, healing of Helicobacter pylori associated duodenal ulcer, prevention and healing of gastric and duodenal ulcers associated with NSAID therapy, prolonged treatment after
i.v. induced prevention of rebleeding of peptic ulcers, treatment of Zollinger Ellison Syndrome.
Pioglitazone is indicated as second or third line in the treatment of type 2 diabetes mellitus as described: as monotherapy (adults): in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is
inappropriate because of contraindications or intolerance. As dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with
metformin. A sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. As triple oral
therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes
mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Essential hypertension. Cardiovascular prevention: reduction of cardiovascular morbidity in patients with: a) Manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral cardiovascular disease). b) Type II
Diabetes mellitus with documented target organ damage.
Adults, adolescents and children≥ 10 years with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and exercise is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (eg, LDL apheresis). Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event as an
adjunct to correction of other risk factors.
15 or 30 Mgr. Tablets. Both available in HDPE bottles of
1000.
20, 40 or 80 Mgr. Tablets. All available in HDPE bottles of
1000.
5, 10 or 20 Mgr. Tablets. All available in HDPE bottles of
1000.
35
Symptomatic treatment of allergic rhinitis (including persistent rhinitis) and urticaria.
In the adult population ofloxacin is limited to the treatment of proven serious and life threatening bacterial infections such as: acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin structure
infections, nongonococcal urethritis and cervicitis, mixed infections of the urethra and cervix, acute pelvic inflammatory disease, uncomplicated cystitis, complicated urinary tract infections, prostatitis and acute, uncomplicated urethral and cervical
gonorrhea.
Treatment for seasonal and perennial allergic rhinitis and urticaria (in adults and children > 2 years).
5 Mgr. Tablets. Also available in HDPE bottles of 1000.
200 or 400 Mgr. Both available in HDPE bottles of 1000.
100 Mgr. Tablets. Also available in HDPE bottles of 1000.
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order to be effective, sexual stimulation is required.
Reduce the risk of myocard infarction. Reduce the risk of stroke. Reduce the risk for revascularization procedures and angina. Hyperlipidemia.
100 Mgr. Tablets. Also available in HDPE bottles of 1000.
Glimepiride is used along with diet and exercise, and sometimes with other medications, to treat type 2 II Diabetes Mellitus.
10 or 20 Mgr. Tablets. Both available in HDPE bottles of
1000.
Atenolol belongs to a group of medicines called beta-blockers. It is used to control high blood pressure, relieve chest pain (angina pectoris), control irregular heart beat, protect the heart in the early treatment after a heart attack.
25, 50 or 100 Mgr. Tablets. All available in HDPE bottles of
1000.
1 or 2 Mgr. Tablets. Both available in HDPE bottles of 1000.
Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide). Use in patients with intravascular
volume depletion. Treatment of chronic heart failure in adult patients when treatment with Angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart
failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart
failure. Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG.
25 or 50 Mgr. Tablets. Both available in HDPE bottles of
1000.
5 or 10 Mgr. Tablets. Both available in HDPE bottles of 1000. Amlodipine is used in the management of hypertension and coronary artery disease.
100 o 200 Mgr. Vaginal Tablets.
CLOTRIMAZEN
VAGINAL
50 Mgr. Capsules. Also available in HDPE bottles of 1000.
10 Mgr. Tablets. Also available in HDPE bottles of 1000.
CLOTRIMAZOLE
VAGINAL
TRADOLZEN
TRAMADOL
METRONIDAZEN 250 Mgr. Tablets.
LORATADIZEN
LORATADINE
40 Mgr. Capsules. Also available in HDPE bottles of 1000.
METRONIDAZOLE
OPRAZOZEN
ESOMEPRAZOLE
Control of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Prevention and treatment of postoperative nausea and vomiting.
The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents.
Lower respiratory tract infections due to Gram-negative bacteria, exacerbations of chronic obstructive pulmonary disease, broncho-pulmonary infections in cystic fibrosis or in bronchiectasis, pneumonia, chronic suppurative otitis media, acute
exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria.
250 or 500 Mgr. Tablets. Both available in HDPE bottles of
1000.
ONDANSETROZEN 4 Mgr. Tablets. Also available in HDPE bottles of 1000.
CIFLOCZEN
CIPROFLOXACIN
Germ infection sensitive to azithromycin. Upper respiratory tract infection: sinusitis, pharyngitis / strep throat. Lower respiratory tract infections: bronchitis, community-acquired pneumonia of mild to moderately severe. Infection of skin and soft
tissue. Acute otitis media. Sexually transmitted diseases: uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis, chancroid (discard conjunction with T. pallidum infection).
250 or 500 Mgr. Tablets. Both available in HDPE bottles of
1000.
ONDANSETRON
AZITROMYZEN
AZITHROMYCIN
Treatment of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. Painful post-traumatic and postoperative inflammation and swelling. Primary dysmenorrhoea.
100 Mgr. Sustained Released Capsules. Also available in
HDPE bottles of 1000.
DOMPERIDOZEN 10 Mgr. Tablets. Also available in HDPE bottles of 1000.
DICLOFENAZEN
DICLOFENAC
Prevention and treatment of folic acid deficiency in pregnant women to prevent miscarriage and “neural tube defects”, birth defects such as spina bifida that occur when the fetus’s spine and back don’t close during development. Treatment of folic acid
deficiency in processes coursing as megaloblastic anemia, alcoholism, malabsorption syndrome.
Relief of symptoms and treatment of knee osteoarthritis (mild to moderate).
INDICATIONS
5 Mgr. Tablets. Also available in HDPE bottles of 1000.
750 Mgr. Capsules or 1500 Mgr. Tablets. Capsules are also
available in HDPE bottles of 1000.
PRESENTATION
DOMPERIDONE
ACIFOLIZEN
GLUCOSAMIZEN
COMMERCIAL
NAME
FOLIC ACID
GLUCOSAMINE
ACTIVE
INGREDIENT
CEFOTAXIZEN
CEFRADIZEN
CEFUROXIZEN AX
CEFPODOXIME
CEPHRADINE
CEFUROXIME
AXETIL
CEFIXIZEN
CEFACLOZEN
CEFACLOR
CEFIXIME
CEFDIZEN
CEFADROXIZEN
CEFADROXIL
CEFDINIR
CEPHALEXIZEN
PERSULZEN
CEFOPERAZONE
AND SULBACTAM
CEPHALEXIN
TRIAXULZEN
CEFEPIZEN
CEFEPIME
ZOSIZEN
CEFPIROZEN
CEFPIROME
CEFTRIAXONE AND
SULBACTAM
PERAZOZEN
CEFOPERAZONE
CEFTRIAXONE AND
TAZOBACTAM
TAZIDIZEN
CEFAZOZEN
CEFAZOLIN
CEFTAZIDIME
CEFOTAZEN
CEFOTAXIME
ZOXIZEN
CEFTRIZEN
CEFTRIAXONE
CEFTIZOXIME
CEFUROXIZEN
CEFUROXIME
ACTIVE
COMMERCIAL
INGREDIENT
NAME
Used in the treatment of severe infections caused by Cefotaxime-sensitive pathogens such as: infections of the respiratory tract, including throat and nose, infections of the ear, kidneys and urinary tract infections, skin and soft tissue infections,
conditions of the bones and joints, infections in the genital organs and abdominal region, septicaemia, bacterial endocarditis & meningitis. For preoperative prophylaxis in patients who are at increased risk from infection and for the prophylaxis of
infections in patients with reduced resistance. Combined treatment: in severe, life-threatening infections, the combination of Cefotaxime Sodium with aminoglycosides is indicated without awaiting the results of sensitivity tests. The two preparations
must be administered separately, not mixed in one syringe of infusion bottle. Infections with Pseudomonas aeruginosa may require treatment with other antibiotics effective against Pseudomonas.
For the treatment of the following infections due to susceptible organisms: respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia,
endocarditis. Perioperative Prophylaxis: the prophylactic administration of Cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which
are classified as contaminated or potentially contaminated (e.g. vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The
perioperative use of Cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin
should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g. open-heart surgery and prosthetic arthroplasty), the prophylactic administration of
Cefazolin may be continued for 3 to 5 days following the completion of surgery.
ZOXIZEN is indicated in the treatment of infections due to susceptible strains of the microorganisms: lower respiratory tract infections, urinary tract infections, pelvic inflammatory disease, intra-abdominal infections, septicemia, skin and skin
structure infections, bone and joint infections, meningitis.
1.000 Mgr. Powder for injection (+/- water for injection).
Available in bulk.
1.000 Mgr. Powder for injection (+/- water for injection).
Available in bulk.
1.000 Mgr. Powder for injection (+/- water for injection).
Available in bulk.
Sulbactam/Cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: respiratory tract infections (Upper and Lower), urinary tract infections (Upper and Lower), peritonitis, cholecystitis, cholangitis,
and other intra-abdominal infections, septicemia, meningitis, skin and soft tissue infections, bone and joint infections, pelvic inflammatory disease, endometritis, gonorrhea, and other infections of the genital tract. Combination therapy: because of the
broad spectrum of activity of sulbactam/cefoperazone, most infections can be treated adequately with there antibiotic alone.
Surgical prophylaxis, intra-abdominal infections, uncomplicated respiratory infections, gynecological infections.
Treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: urinary tract infections caused by E. Coli, P. Mirabilis and Klebsiella species, skin and skin structure infections caused by
staphylococci and/or streptococci, pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. To reduce
the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxizen-500 capsules and other antibacterial drugs, Cefadroxizen Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria.
Pharyngitis/tonsillitis caused by S. pyogenes, acute bronchitis, exacerbation of chronic bronchitis and pneumonia caused by B. catarrhalis, S. pneumoniae and H. influenzae. Otitis media and acute sinusitis caused by H. influenzae, B. catarrhalis, S.
pyogenes and S. pneumoniae. Uncomplicated tract infection caused by E. coli and P. mirabilis.
100 or 200 Mgr. Tablets. Also available in 50mgr/5ml
(30ml) or 100mgr/5ml (30ml) Oral Suspension. Also
available in 100 Mgr. Sachets.
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It is prescribed in the treatment of certain infections caused by susceptible strains: upper respiratory tract infections (otitis media, sinusitis, pharyngitis/tonsillitis caused by S. pyogenes), lower respiratory trac infections (acute bronchitis, communityacquired pneumonia, infected bronchiectasis, lung abscess and post operative chest infections), urinary tract infections, skin and soft tissue infections, gonorrhoea (when penicillin is contraindicated), septicemia.
250 or 500 Mgr. Tablets. Also available in 125mgr/5ml
(30ml) Oral Suspension.
It is prescribed in the treatment of certain infections caused by susceptible bacterial strains causing respiratory, genitourinary, gastrointestinal, skin and soft tissue, and bone and joint infections, or septicemia, osteoarticular infection, endocarditis and
meningitis-N. meningitidis.
Recurrent and chronic tonsillitis, pharyngitis, sinusitis and acute otitis media, acute bronchitis, bacterial pneumonia, lower respiratory infection; uncomplicated urinary tract infections, pyelonephritis, uncomplicated gonococcal urethritis and skin and
soft-tissue infections.
100 or 200 Mgr. Tablets/Capsules or 50mgr/5ml (30ml)
Oral Suspension.
250 Mgr. Capsules.
CEFACLOZEN is indicated in the treatment of the following infections when caused by susceptible strains of micro-organisms: lower respiratory infections, acute bronchitis, and acute exacerbations of chronic bronchitis, upper respiratory infections,
including pharyngitis and tonsillitis (Note: penicillin is the usual medicine of choice in the treatment and prevention of streptococcal), infections, including the prophylaxis of rheumatic fever, otitis media, skin and soft-tissue infections, urinary tract
infections (Note: Cefaclor has been found to be effective in both acute and chronic urinary tract infections), skin and skin structure infections, sinusitis.
250 Mgr. Capsules. Available in bulk.
300 Mgr. Capsules or 125 mgr/5ml (30ml) Oral Suspension. Respiratory tract infections (Upper and Lower), community-acquired pneumonia, pharyngitis, otitis, bronchitis, sinusitis, skin and soft tissue infections.
500 Mgr. Capsules.
500 Mgr. Capsules or 125mgr/5ml (30ml) Oral Suspension. Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, genitourinary tract infections, including acute
Both available in bulk.
prostatitis, gynecological infections. Cephalexin may be used to treat a number of other bacterial infections.
500 + 500 Mgr or 1.000 + 1.000 Mgr. Powder for injection.
250 + 125 Mgr. or 1.000 + 500 Mgr. Powder for injection.
Lower respiratory tract infection, skin and skin structure infections, urinary tract infections, gynecological infections, intra-abdominal infections.
Pneumonia, empiric therapy for febrile neutropenic patients, uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, complicated intra-abdominal infections (used in
combination with metronidazole), septicaemia.
1000 + 125 Mgr. Powder for injection.
Lower respiratory tract infections, bronchopneumonia, lobar pneumonia; complicated upper (pyelonephritis) and lower urinary tract infections; skin and soft tissue infections; bacteraemia/septicaemia.
1.000 Mgr. Powder for injection (+/- water for injection).
Available in bulk.
Cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: respiratory tract infections, peritonitis and other intra-abdominal infections, bacterial septicemia, infections of the skin and skin structures,
pelvic inflammatory disease, endometritis, and other infections of the female genital tract, urinary tract infections, enterococcal infections.
1.000 Mgr. Powder for injection (+/- water for injection).
1.000 Mgr. Powder for injection (+/- water for injection).
Serious infections (septicemia, bacteraemia, peritonitis, meningitis); infections in immunosuppressed patients; respiratory tract infections including lung infections in cystic fibrosis; ear, nose and throat infections; urinary tract infections; skin and soft
tissue infections; gastrointestinal, biliary and abdominal infections; bone and joint infections; infections associated with haemo and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD).
Infections caused by pathogens sensitive to Ceftriaxone: respiratory tract infections, particularly pneumonia, and ear, nose and thorat infections, renal and urinary tract infections, sepsis, meningitis, abdominal infections (peritonitis, infection of the
biliary and gastrointestinal tracts), infections of the bones, joints, soft tissue, skin and of wounds, infections in patients with impaired defence mechanisms, genital infections (including gonorrhoea), perioperative prophylaxis.
1.000 Mgr. Powder for injection (+/- water for injection).
Available in bulk.
1.000 Mgr. Powder for injection (+/- water for injection).
For the treatment of the following conditions caused by susceptible organisms: lower respiratory tract infections, including pneumonia, urinary tract infections, skin and skin-structure infections, septicemia, meningitis, gonorrhea, bone and joint
infections caused by Staphylococcus.
INDICATIONS
750 Mgr. or 1.500 Mgr. Powder for injection (+/- water for
injection). Available in bulk.
PRESENTATION
3. CONTACT.
GALIZEN CONSULTING, S.L.
Plaza Barcelos, Nº 27, 6º B
C.P.:36002. Pontevedra. Spain
Website: http://www.galizen.com/
E-mail: [email protected]
Phone: +34 676 389 096
37