MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Public Assessment Report Mutual Recognition Procedure Sodium Chloride 0.9% w/v Injection BP MRP no: UK/H/0859/001/MR UK licence no: PL 24598/0002 Applicant: Noridem Enterprises Limited 1 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Sodium Chloride 0.9% w/v Injection BP PL 24598/0002; UK/H/0859/001/MR LAY SUMMARY On 11th November 2007, Austria, Belgium, Denmark, Germany, Greece, Ireland, The Netherlands, Norway, Portugal, Spain and Sweden approved Noridem Enterprises Limited Marketing Authorisations (licences) for the medicinal product Sodium Chloride 0.9% w/v Injection BP (PL 24598/0002). This application was by mutual recognition procedure with the UK as Reference Member State (RMS). A national licence had previously been granted in the UK on 26th August 2004. This is a prescription-only medicine (POM) to be used to dissolve or dilute some medicines so that they can be given as an injection or infusion (a drip) into veins, muscles or other tissues in the body. It can also be used in the preparation of a number of surgical and medical procedures, as follows: • To clean out catheters (small devices put in your veins to inject your medicine) • As a priming solution to fill intravenous lines (long tubes connected to your veins). This is to make sure that there is no air being injected, in procedures such as haemodialysis (a procedure to clean the blood when you have kidney disease) • As a priming solution at the beginning and end of blood transfusions without causing damage to the blood cells. Sodium Chloride 0.9% w/v Injection BP is a type of medicine called an electrolyte. It is a sterile salt liquid that can be used for a number of different reasons as it is very similar to your bodily fluids. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of using Sodium Chloride 0.9% w/v Injection BP outweighed the risks, hence a Marketing Authorisation has been granted. 2 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Product Information Leaflet Page 12 Module 4: Labelling Page 17 Module 5: Scientific Discussion Page 21 1 Introduction 2 Quality aspects 3 Non-clinical aspects 4 Clinical aspects 5 Overall conclusions Module 6 Steps take after initial procedure Not applicable 3 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Module 1 Product Name Sodium Chloride 0.9% w/v Injection BP Type of Application Known Active Substance Initial application Bibliographic (Article 10a) Chemical substance Prescription only Sodium chloride Solvent for parenteral use, 0.9% w/v Noridem Enterprises Ltd, Evagorou & Makariou, Mitsi Building 3, Suite 115, 1065 Nicosia, Cyprus United Kingdom Austria, Belgium, Denmark, Germany, Greece, Ireland, The Netherlands, Norway, Portugal, Spain, Sweden UK/H/0859/001/MR Day 90: 11/11/2007 Active Substance Form MA Holder RMS CMS Procedure Number Timetable 4 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Module 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT UK: Sodium Chloride 0.9% w/v Injection BP. BE: Sodium Chloride Noridem 0.8% w/v Injection BP DK: Natriumklorid Noridem ES: Sodium Chloride Noridem 9mg/ml (0.9%), solution for injection SE: Natriumklorid Noridem 9mg/ml, solution for injection NO: Natriumklorid Noridem 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride 9mg/ml or 0.9%w/v (Ph. Eur.) For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection and solvent for parenteral use. A clear colourless liquid. 4 4.1 CLINICAL PARTICULARS Therapeutic indications Sodium chloride injection is indicated as a pharmaceutical aid and diluent for the infusion of compatible drug additives and for diluting or dissolving drugs for parenteral administration. Other indications for sodium chloride injection include flushing of IV catheters, as a priming solution in haemodialysis procedures and to initiate and terminate blood transfusions without haemolysing red blood cells. Sodium chloride injection may be added to compatible carbohydrate solutions such as dextrose in water to produce electrolytes. 4.2 Posology and method of administration Dosage: The volume given and administration rate are dependent upon the additive. Administration: For parenteral use. The directions for use of the additive will dictate the administration route. 4.3. Contraindications Hypernatremia, hyperchloremia and those contraindications related to the additive. 4.4. Special warnings and precautions for use Newborn babies, both premature and at term, may exhibit excessively high sodium levels due to immaturity if renal function. As a result, in newborn babies, both premature and at term, repeated injections of sodium chloride may only be given after determining blood serum levels. Sodium Chloride must be used with caution in patients with hypertension, heart failure, pulmonary or peripheral oedema, impaired renal function, pre-eclampsia, hypreraldosteronism, and other diseases and treatments (e.g. corticosteroids) associated with sodium retention. 4.5 Interaction with other medicinal products and other forms of interaction None known when used as a diluent or priming solution. 4.6 Pregnancy and lactation This solution does not present any hazard to pregnant women, to the foetus or to the breast-fed child. 4.7 Effects on ability to drive and use machines None stated. 5 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR 4.8. Undesirable effects Unwanted reactions may be associated with the administration technique and consist of fever, infection at the injection site, local pain or reaction, venous irritation, venous thrombosis or ohlebitis spreading from the injection site, extravasation 4.9 Overdose Administration of quantities which may have adverse effects is very unlikely as vials contain a maximum of 20 ml. 5 5.1 PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties Pharmacotherapeutic group: B05X A03 Sodium chloride is the principal salt involved in the maintenance of plasma and other tissues tonicity. Solutions of sodium chloride closely approximate the composition of the extracellular fluid of the body; more than 90% of the cation of the extracellular fluid is sodium and more than 60% of the anion is chloride. Furthermore, a 0.9% solution of sodium chloride is approximately isotonic with body fluids. Thus, an injection of 0.9% sodium chloride will not appreciably affect the osmotic pressure of the body or the chemical composition of the extracellular fluid. A 0.9% solution of sodium chloride is therefore the choice of solvent for many drugs which have to be administered parenterally. The solution has the added advantage of being non-irritating to tissue. 5.2 Pharmacokinetic properties Not appropriate. 5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber which are not included in other sections of the SPC. 6 6.1 PHARMACEUTICAL PARTICULARS List of Excipients Water for Injection Ph. Eur. 6.2 Major incompatibilities Compatibility should be checked when sodium chloride injection is used as a diluent or solvent. 6.3 Shelf life 2 years. Discard after single use, discard any unused portion. 6.4 Special precautions for storage Store below 25°C. 6.5 Nature and contents of container Polypropylene ampoules, of 5 or 10 ml, packed into cartons of 50 ampoules, or of 20 ml, packed into cartons of 20 ampoules. Not all pack sizes may be marketed 6.6 Special precautions for disposal Use only if the solution is clear without visible particles. Discard after single use. Discard any unused portion. 7. MARKETING AUTHORISATION HOLDER Noridem Enterprises Ltd., (trading as Fannin) Evagorou & Makariou, Mitsi Building 3, Suit.115, 1065 Nicosia, Cyprus. 6 MRPAR Sodium Chloride 0.9% w/v Injection BP 8 MARKETING AUTHORISATION NUMBER 24598/0002 9 DATE OF THE FIRST AUTHORISATION OR RENEWAL 7 September 2005 10 DATE OF REVISION OF THE TEXT 17/07/2008 UK/H/0859/001/MR 7 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Module 3 8 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Module 4 Labelling 9 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR 10 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR 11 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR 12 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR Module 5 Scientific discussion during initial procedure 1. INTRODUCTION Background This application was submitted by Noridem Enterprises Limited for Sodium Chloride 0.9% w/v Injection BP, via the Mutual Recognition Procedure. The UK acted as Reference Member State for the procedure, which was granted a UK licence on 26th August 2004. Sodium Chloride 0.9%w/v Injection is indicated as a pharmaceutical aid and diluent for the infusion of compatible drug additives and for diluting or dissolving drugs for parenteral administration. Other indications for sodium chloride injection include flushing of IV catheters, as a priming solution in haemodialysis procedures and to initiate and terminate blood transfusions (without haemolysing red blood cells). Sodium chloride injection may be added to compatible carbohydrate solutions, such as dextrose in water, to produce electrolytes. Based on the review of the data on quality, safety and efficacy, the RMS considered that the application for Sodium Chloride 0.9% w/v Injection BP could be approved for the indications stated above. Day 90 for the procedure was 11th November 2007, subsequent to which Marketing Authorisations were approved in Austria, Belgium, Denmark, Germany, Greece, Ireland, The Netherlands, Norway, Portugal, Spain and Sweden. Overall Benefit/Risk Assessment Sodium Chloride 0.9% w/v Injection BP is a well-known and widely used solvent. It is compatible with an extensive number of substances and can be used as a vehicle/diluent for the parenteral administration of other medicinal products. No preclinical studies were conducted, and none are required as the product is well-established for medicinal use. No clinical studies were conducted, and none are required as the product is well-established for medicinal use. The RMS has been assured that acceptable standards of GMP are in place at all sites responsible for the manufacture and assembly of this product prior to granting its national authorisation. For manufacturing sites within the community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at this site. 2. QUALITY ASPECTS S. Active Substance Synthesis of the drug substance from the designated starting materials has been adequately described, and appropriate in-process controls and intermediate specifications 13 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR are applied. Satisfactory specification tests are in place for all starting materials and reagents, and these are supported by relevant certificates of analysis. An appropriate specification is provided for the active substance sodium chloride, with suitable test methods and limits. Batch analysis data are provided and comply with the proposed specification. The active sodium chloride is packaged in multiple layer paper bags. Suitable specifications have been provided for all packaging materials and the primary packaging has been shown to comply with current guidelines concerning contact with foodstuff. Appropriate shelf-lives have been set for active sodium chloride, based on the available stability data provided by the active substance manufacturers. No formal stability data has been provided by the applicant, which is acceptable given that the active is known to be very stable and the European Pharmacopoeia monograph contains no degradation products. P. Medicinal Product Other Ingredients The only excipient used in this product is water for injections. Satisfactory certificates of analysis have been provided to show that it complies with the current European Pharmacopoeia monograph. No excipients of human or animal origin are used in this product. No genetically modified organisms are used in this product. Pharmaceutical Development The objective of the development programme was to produce a solution for injection containing 0.9% w/v sodium chloride that complied with the current British Pharmacopoeia monograph. Manufacturing Process An appropriate account of the manufacturing process has been provided. The manufacturing process has been validated and has shown satisfactory results. Finished Product Specification The finished product specification is satisfactory and in-line with the current British Pharmacopoeia monograph. Test methods have been described and have been adequately validated, as appropriate. Batch data have been provided and comply with the release specification. Certificates of analysis have been provided for any working standards used. Container-Closure System The product is packed into polypropylene 5 or 10ml ampoules packed into cartons of 50 or 20ml ampoules packed into cartons of 20. Satisfactory specifications and certificates of analysis have been provided for all packaging components. All primary packaging complies with the relevant regulations regarding materials for parenteral use. Product Stability Stability studies were performed in the packaging proposed for marketing and in accordance with current guidelines. All results from stability studies were within 14 MRPAR Sodium Chloride 0.9% w/v Injection BP UK/H/0859/001/MR specified limits. These data support a shelf-life of 2 years with the storage condition ‘Store below 25°C’. Bioequivalence/Bioavailability No bioequivalence studies have been submitted for this application and none were required. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), Labels The SPC, PIL and Labels are pharmaceutically acceptable. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC, as amended. The results indicate that the package leaflet is wellstructured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. MAA Forms The MAA forms are pharmaceutically satisfactory. Expert Report The pharmaceutical expert report has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical dossier. Conclusion The grant of a marketing authorisation is recommended. 3. PRE-CLINICAL ASPECTS No new preclinical data have been supplied with this application and none are required for an application of this type. 4. CLINICAL ASPECTS Clinical Pharmacology No new data were submitted and none are required for this type of application. Efficacy No new data were submitted and none are required for this type of application. Safety No new data were submitted and none are required for this type of application. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), Labels The SPC, PIL and labels are medically acceptable. The SPC is consistent with that for other similar products. Conclusion The grant of a marketing authorisation is recommended. 15 MRPAR Sodium Chloride 0.9% w/v Injection BP 5. UK/H/0859/001/MR OVERALL CONCLUSION QUALITY The important quality characteristics of Sodium Chloride 0.9% w/v Injection BP are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new preclinical data were submitted and none were required for an application of this type. EFFICACY No significant new or unexpected safety concerns were found during the clinical development. The SPC, PIL and labelling are appropriate for a product of this type. BENEFIT-RISK ASSESSMENT The quality of the product is acceptable and no new preclinical or clinical safety concerns have been identified. Extensive clinical experience with Sodium Chloride 0.9% w/v Injection BP is considered to have demonstrated the therapeutic value of the compound. The benefit-risk is considered to be positive. 16
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