Land: Malta
Sprog: engelsk
Kilde: Malta Medicines Authority
WATER FOR, INJECTIONS
DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece
V07AB
WATER FOR INJECTIONS 14.5 % (W/V)
SOLUTION FOR INFUSION OR INJECTION
WATER FOR INJECTIONS 14.5 % (W/V)
POM
ALL OTHER NON-THERAPEUTIC PRODUCTS
Withdrawn
2007-04-04
WATER FOR INJECTION COMPOSITION: Active ingredient: Water for injections Excipient: None PHARMACOTECHNICAL FORM: Solvent for parenteral use. CONTENT IN ACTIVE INGREDIENT: Each container contains 100% w/v Water for injections. DESCRIPTION – PACKAGING: Water for Injection is a clear, colorless liquid and is packed in polyethylene bottles of 100, 250, 500 and 1000ml and in polypropylene bags of 100, 250, 500 and 1000ml. PHARMACOTHERAPEUTIC CATEGORY: Solvents and dilution agents. MARKETING AUTHORIZATION HOLDER – MANUFACTURER: DEMO SA, 21 st km National Road Athens - Lamia, 145 68 Kryoneri, Athens, Greece, Tel. +30 210 8161802, Fax: +30 210 8161587 GENERAL INFORMATION: Since Water for Injection is only the vehicle used for the administration of other pharmaceutical products, the pharmacokinetic and pharmacodynamic properties depend on the nature of the drug being added. INDICATIONS: Water for Injection is used as a dilution and reconstitution agent for other pharmaceutical products for parenteral administration. CONTRAINDICATIONS: Water for Injection should not be administered as it is. Contraindications related to the drug being added should be taken into account. SPECIAL PRECAUTIONS AND WARNINGS DURING USE: Water for Injection is hypotonic and therefore should not be administered as it is. It should not be used for intravenous infusion, unless it has been adjusted in the appropriate isotonicity with an appropriate solvent. When Water for Injection is used as a dilution agent for hypertonic solutions, appropriate dilution should be made so as to make the final solution as isotonic as possible. Haemolysis may be induced after infusion of large volumes of hypotonic solutions using sterile Water for Injection as a dilution agent. When large volumes are administered, Læs hele dokumentet
Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. N AME OF THE MEDICINAL PRODUCT Water for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each container contains 100%w/v water for injection. 3. P HARMACEUTICAL F ORM Solvent for parenteral use. A clear colorless liquid 4. C LINICAL I NFORMATION 4.1 THERAPEUTIC INDICATIONS It is used for the preparation of parenteral solutions of some pharmaceutical substances that remain stable only in a dry state. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous use, intravenous drip infusion. 4.3 CONTRAINDICATIONS i) Water for injections must not be administrated alone. ii) Contraindications related to the drug being added should be taken into account. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Water for injection is hypotonic and it should not be administered as it is, because it may cause haemolysis. Water for injection should not be used for intravenous infusion, unless it has been adjusted in the appropriate isotonicity with an appropriate solvent. When water for injection is used as a dilution agent for hypertonic solutions, appropriate dilution should be made so as to make the final solution as isotonic as possible. When large volumes are administrated ionic balance should be checked regularly. Aseptic methods should be used for the preparation of the infusion product (sterilization of the cap and the infusion point, usage of a new and sterile infusion machine). The clarity, the shade and the absence of visible particles should be checked before usage. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not applicable 4.6 PREGNANCY AND LACTATION Not applicable 4.7 EFFECTS ON THE ABILITY TO DRIVE AND OPERATE MACHINES Not applicable Page 2 of 2 4.8 UNDESIRABLE EFFECTS If the water for injection is injected as it is, it may cause haemolysis. 4.9 OVERDOSE Læs hele dokumentet