Summary of Product Characteristics (SmPC) - Water for Injections
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections
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
Solution for injection/infusion
4.1 Therapeutic indications
For use as a solvent for reconstitution of suitable medicinal products
4.2 Posology and method of administration
Posology
Not applicable
Method of administration
Not applicable
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
None
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.
4.8 Undesirable effects
None.
4.9 Overdose
None.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvent and diluting agent
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
None.
6.3 Shelf life
2.5, 3, 4, 5, 5.6, 10, 15, 20, 40, 50 ml: 60 months 2 ml: 30 months
6.4 Special precautions for storage
Do not store above 30°C.
2ml: Do not store above 25°C.
Do not freeze.
6.5 Nature and contents of container
Pack sizes Container details
2 ml, 2.5 ml, 3 ml, 4 ml, 5 ml
5.6 ml, 10 ml
15 ml
20 ml
40 ml, 50 ml
In 6 ml injection vial clear glass type I (Ph. Eur.) with chlorobutyl or bromobutyl rubber infusion stopper and cap
In 10 ml injection vial clear glass type I (Ph. Eur.) with chlorobutyl or bromobutyl rubber infusion stopper and cap
In 15 ml injection vial clear glass type I (Ph. Eur.) with chlorobutyl or bromobutyl rubber infusion stopper and cap
In 25 ml injection vial clear glass type I (Ph. Eur.) with chlorobutyl or bromobutyl rubber infusion stopper and cap
In 50 ml injection vial clear glass type I (Ph. Eur.) with chlorobutyl or bromobutyl rubber infusion stopper and cap
6.6 Special precautions for disposal and other handling
- Do not use after the expiry date given on the carton and vial label.
- Do not use visibly cloudy solutions or solutions still containing flakes or particles.
- Reconstitution and withdrawal must be carried out under aseptic conditions.
- Any unused solution should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
8 MARKETING AUTHORISATION NUMBER
PL 15036/0015
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31st December1997
10 DATE OF REVISION OF THE TEXT
09/07/2023