Water For Injections
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterilised water for injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100% Water for Injections
3 PHARMACEUTICAL FORM
Solution for injection
Clear glass ampoules containing, 2ml, 5ml, 10ml or 20ml Sterilised water for injections
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sterilised water for injections is used as a dissolvent and diluent for injectable medicines.
4.2 Posology and method of administration
Sterilised water for injections is administered by Intravenous Injection. Dosage for Adults (including the elderly) and Children:- as required, by intravenous injection.
4.3 Contraindications
None known.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
None known.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
None known.
5.1 Pharmacodynamic properties
ATC code K4D - Other injection solutions/infusions.
Sterilised water for injections is used as a dissolvent and diluent for injectable medicines
5.2 Pharmacokinetic properties
Not Applicable
5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None known
6.3 Shelf life
60 months
6.4 Special precautions for storage
Store below 25° C
6.5 Nature and contents of container
Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml
6.6 Special precautions for disposal
Only to be used as a diluent
7 MARKETING AUTHORISATION HOLDER
Hameln Pharmaceuticals Limited,
Nexus, Hurricane Lane,
Gloucester Business Park,
Gloucester GL3 4AG,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 01502 / 0069
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/10/2006
10 DATE OF REVISION OF THE TEXT
25/02/2015