Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Water for injection
CSL Behring GmbH
V07AB
Water for injection
.
Solvent for parenteral use
Solvents and diluting agents, incl. irrigating solutions
Not marketed
2019-08-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER WATER FOR INJECTIONS 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 is and what it is used for 2. What you need to know before you use Water for Injections 3. How to use Water for Injections 4. Possible side effects 5. How to store Water for Injections 6. Contents of the pack and other information 1. WHAT WATER FOR INJECTIONS 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 The following sections contain information that you and your doctor should consider before you use Water for Injections. DO NOT USE WATER FOR INJECTIONS • as an injection or infusion on its own Water for Injections 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. This will tell you whether or not you can receive the solution. WARNINGS AND PRECAUTIONS Water for Injections should not be used on its own. Before you use Water for Injections: • it should always be mixed with one or more medicines Before you are given medicines mixed with Water for Injections your doctor will check that: • the medicines are stable in Water for Injec Read the complete document
Health Products Regulatory Authority 24 January 2022 CRN00CGVY Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Water for Injections 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 50ml 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 on its own 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Water for Injections is hypotonic and it should not be administered alone 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None 4.6 FERTILITY, PREGNANCY AND LACTATION None 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None 4.8 UNDESIRABLE EFFECTS None Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance Section, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; website: www.hpra.ie; Email: medsafety@hpra.ie Health Products Regulatory Authority 24 January 2022 CRN00CGVY Page 2 of 3 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 Sum Read the complete document