Water For Injections
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for Injections
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as a diluent for reconstitution of CSL Behring coagulation products
4.2 Posology and method of administration
Posology Not applicable
Method of administration Intravenous injection.
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
None
Interaction with other medicinal products and other forms of interaction
4.5
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
60 months
6.4 Special precautions for storage
Avoid freezing which may damage the container.
6.5 Nature and contents of container
Pack sizes Container details
4 ml, 10 ml, 15 ml, 20 ml Injection vial clear glass type I (Ph. Eur)
with rubber infusion stopper and cap.
6.6 Special precautions for disposal
Do not use after the expiry date given on the pack and container.
Do not use solutions, which are cloudy or contain residues (deposits/particles). Reconstitution and withdrawal must be carried out under aseptic conditions.
After administration, any unused solution and the administration equipment must be discarded appropriately.
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
02/07/2015