Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
WATER FOR, INJECTION
CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
V07AB
WATER FOR INJECTION
SOLVENT FOR PARENTERAL USE
WATER FOR INJECTION
POM
ALL OTHER NON-THERAPEUTIC PRODUCTS
Authorised
2019-03-04
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER WATER FOR INJECTIONS CSL BEHRING Solvent for parenteral use READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Water for Injections CSL Behring is and what it is used for 2. What you need to know before you use Water for Injections CSL Behring 3. How to use Water for Injections CSL Behring 4. Possible side effects 5. How to store Water for Injections CSL Behring 6. Contents of the pack and other information 1. WHAT WATER FOR INJECTIONS CSL BEHRING IS AND WHAT IT IS USED FOR Sterilised Water for Injections is used to dissolve and dilute other medicines that require mixing with water before they can be given as an injection or an infusion (a drip) into your veins, muscles or other tissues in the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE WATER FOR INJECTIONS CSL BEHRING The following sections contain information that you and your doctor should consider before you use Water for Injections CSL Behring. DO NOT USE WATER FOR INJECTIONS CSL BEHRING • as an injection or infusion on its own Water for Injections CSL Behring must only be used to dissolve or dilute necessary drugs. You should read the Patient Information Leaflet of your medicine or medicines that are being mixed with Water for Injections CSL Behring. This will tell you whether or not you can receive the solution. WARNINGS AND PRECAUTIONS Water for Injections CSL Behring should not be used on its own. Before you use Water for Injections CSL Behring: • it should always be mixed Olvassa el a teljes dokumentumot
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Water for Injections CSL Behring solvent for parenteral use _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ 1 vial contains 2, 2.5, 3, 4, 5, 5.6, 10, 15, 20, 40 or 50 ml water for injections _ _ 3. PHARMACEUTICAL FORM Solvent for parenteral use. Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use as a solvent for reconstitution of suitable medicinal products for parenteral use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and method of administration depend on the instructions given for the medicinal product to be dissolved or diluted. 4.3 CONTRAINDICATIONS Do not administer Water for Injections CSL Behring on its own. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Water for injection is hypotonic and it should not be administered alone. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None 4.6 FERTILITY, PREGNANCY AND LACTATION None 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None Page 2 of 4 4.8 UNDESIRABLE EFFECTS None 4.9 OVERDOSE None 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Solvent and diluting agent ATC code: V07AB Pharmacodynamics: Not applicable 5.2 PHARMACOKINETIC PROPERTIES Not applicable 5.3 PRECLINICAL SAFETY DATA Not applicable 6. PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Not applicable 6.2 INCOMPATIBILITIES For possible interactions and incompatibilities check Summary of Product Characteristics and Package Information Leaflet of the medicinal product which is intended to be reconstituted with Water for Injections CSL Behring. Those medicinal products known to be incompatible with water for injections must not be used. 6.3 SHELF LIFE 2.5, 3, 4, 5, 6, 10, 15, 20, 40, 50 mL: 5 years 2 mL: 30 months After opening, the product must be used immediately. For in use shelf life, after reconstitution of the medicinal product, check Summary of Product Characteristics and Package Information Leaflet of the Olvassa el a teljes dokumentumot