Bacteriostatic Saline For Injection
1. NAME OF THE MEDICINAL PRODUCT
Bacteriostatic Saline for Injection
2. 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
3. PHARMACEUTICAL FORM
4.1 Therapeutic indications
To be used to reconstitute certain medicinal products.
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 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: www.mhra.gov .uk/yellowcard.
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code: V07AB
Benzyl alcohol Sterile water for injection
Store below 25°C. Discard any remaining solution after use.
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.
No special requirements.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Date of first authorisation: 15 February 1990 Date of latest renewal: 23 May 2003