Water For Injections
PRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT
Water for Injections BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable.
3. PHARMACEUTICAL FORM
Injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
As a diluent.
4.2 Posology and Method of Administration
Route of Administration Parenteral.
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 BP
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
3 years.
6.4. Special Precautions for Storage
Store below 30°C
6.5. Nature and Content of Container
Colourless 2ml type 1 neutral glass ampoules.
6.6. Instruction for Use, Handling and Disposal
Not applicable.
ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
Glaxo Wellcome UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
8. MARKETING AUTHORISATION NUMBER(S)
PL 10949/0092
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15th October 1998
10. DATE OF (PARTIAL) REVISION OF THE TEXT
June 1998. This is the first SmPC.