Water For Injections Ph.Eur.
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT
Water for Injection Ph.Eur.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for injections 100.0 v/v
3. PHARMACEUTICAL FORM
Solvent or suspension medium in ampoules for dry substances for injection.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Not applicable (to be used as a suspension for a prescription only medicine).
4.2. Posology and Method of Administration
As 4.1
4.3. Contra-Indications
Not applicable.
4.4. Special Warnings and Special Precautions for Use
Not applicable.
4.5. Interactions 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.
5.3. Pre-clinical Safety Data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Water for Injections Ph.Eur. 100.0 v/v
6.2. Incompatibilities
None
6.3. Shelf-Life
6.4. Special Precautions for Storage
None.
6.5. Nature and Content of Container
Colourless glass ampoules, Glass Type I, according to Ph.Eur. in packs containing 5 or 10 ampoules.
6.6. Instructions for Use, Handling and Disposal
None.
ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
Novartis Pharmaceuticals UK Limited
T/A Ciba Laboratories
Frimley Business Park
Camberley
Surrey
GU6 7SR
8. MARKETING AUTHORISATION NUMBER(S)
PL 00101/0479
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
1 August 1997
10. DATE OF (PARTIAL) REVISION OF THE TEXT
November 1997