WATER FOR INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

WATER FOR INJECTIONS

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

B05XX

Pharmaceutical form:

SOLVENT FOR PARENTERAL USE

Composition:

WATER FOR INJECTIONS 100 %

Administration route:

PARENTERAL

Prescription type:

Not required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic group:

OTHER I.V. SOLUTION ADDITIVES

Therapeutic indications:

preparation and dilution of medicines for parenteral administration

Authorization date:

2020-03-31

Summary of Product characteristics

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