Country: Իսրայել
language: անգլերեն
source: Ministry of Health
WATER FOR INJECTIONS
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
B05XX
SOLVENT FOR PARENTERAL USE
WATER FOR INJECTIONS 100 %
PARENTERAL
Not required
B.BRAUN MELSUNGEN AG, GERMANY
OTHER I.V. SOLUTION ADDITIVES
preparation and dilution of medicines for parenteral administration
2020-03-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT WATER FOR INJECTION 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml solution contain: Water for injections 100 ml 3 PHARMACEUTICAL FORM Solvent for parenteral use Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Preparation and dilution of medicines for parenteral administration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Water for injection is used for dilution or dissolution of parenteral medicinal products. Dosage and duration of use depend on the instructions given for the medicinal product to be dissolved or diluted. Paediatric population The dosage should be based on the instructions given for the medicinal product to be dissolved or diluted. Method of administration The method of administration depends on the instructions given for the medicinal product to be dissolved/diluted. The medicinal product should be dissolved or diluted immediately before use. 4.3 CONTRAINDICATIONS There are no contraindications for water for injections as such. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Special warnings Water for injection must not be injected as such. Precautions for use 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Interactions between water for injection and other medicinal products are not known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Generally, water for injection can be used during pregnancy. Breast-feeding Water for injection can be used during breasteeding. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Water for injection has no influence on the ability to drive and use machines. 4.8 UNDESIRABLE EFFECTS None knownif used according to the instructions given. If water for injection is administered intravenously without additives, it may cause haemolysis and hypotonic disorders in the electrolte metabolism. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows conti read_full_document