Water For Injections Ph.Eur.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph.Eur.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
3 PHARMACEUTICAL FORM
Solution for Injections
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as a diluent for reconstitution of injectables
4.2 Posology and method of administration
Not applicable
4.3 Contraindications
Not applicable
4.4 Special warnings and precautions for use
Not applicable
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 ability to drive and use machines
Not applicable
4.8 Undesirable effects
Not applicable
4.9 Overdose
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable
5.2 Pharmacokinetic properties
Not applicable
Preclinical safety data
5.3
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable
6.2 Incompatibilities
No known incompatibilities.
6.3 Shelf life
60 months.
6.4 Special precautions for storage
Do not store above 30°C. Do not freeze.
6.5 Nature and contents of container
Glass Type I 10 ml syringe for 5 ml
Glass Type I 10 ml syringe for 10 ml Glass Type I 20 ml syringe for 15 ml
6.6 Special precautions for disposal
For use as a diluent for reconstitution of lyophilised injectables
7 MARKETING AUTHORISATION HOLDER
Grifols UK Ltd
St Andrews Road Cambridge CB4 1DP
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MARKETING AUTHORISATION NUMBER(S)
PL 04447/0016
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
5th October 1989
DATE OF REVISION OF THE TEXT
25/04/2008
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