Water For Injection Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Steri-Amp Water for Injections BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for Injections Ph. Eur 100.00%.
3. PHARMACEUTICAL FORM
Sterile solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
To be used in preparation or dilution of small volume injections.
4.2 Posology and method of administration
As required.
4.3 Contraindications
Not applicable.
4.4 Special warnings and precautions for use
Do not use unless the product is clear, or if there is evidence of leakage. Discard any surplus after use.
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 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients
None.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate.
6.5 Nature and contents of container
Plastic ampoule with a snap open closure containing 5ml, l0ml and 20ml.
6.6 Instructions for use and handling
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited
Trading as Ivax Pharmaceuticals UK
Albert Basin
Royal Docks
London
E16 2QJ
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00530/0686
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/10/2005
10 DATE OF REVISION OF THE TEXT
28/10/2005