BACTERIOSTATIC SALINE FOR INJECTION
Active substance(s): SODIUM CHLORIDE
NAME OF THE MEDICINAL PRODUCT
Bacteriostatic Saline for Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains sodium chloride, 0.9% w/v.
Excipient(s) with known effect
Each vial contains benzyl alcohol, 0.9% w/v.
For the full list of excipients, see section 6.1
To be used to reconstitute certain medicinal products.
Posology and method of administration
Special warnings and precautions for use
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
Effects on ability to drive and use machines
Benzyl alcohol is contained in the diluent and has been reported to be associated with a fatal "gasping
syndrome" in premature infants.
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:
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code:
Preclinical safety data
List of excipients
Sterile water for injection
Special precautions for storage
Store below 25°C. Discard any remaining solution after use.
Nature and contents of container
Type I flint glass vials and rubber closures (EP) which are sealed with a flip-top aluminium
cap. Vials contain 18.5 ml or 50 ml.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Kent CT13 9NJ
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 15 February 1990
Date of latest renewal: 23 May 2003
DATE OF REVISION OF THE TEXT