Not applicable.
5 years.
Not applicable.
Not applicable.
Benzyl alcohol
Sterile water for injection
Sterile Solution
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.
To be used to reconstitute certain medicinal products.
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code: V07AB
Not applicable.
08/2016
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
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.
PL 00057/1513
Not applicable.
Each vial contains sodium chloride, 0.9% w/v.
Excipient(s) with known effect
Each vial contains benzyl alcohol, 0.9% w/v.
Not applicable.
Not applicable.
Extra-amniotic only.
No special requirements.
Date of first authorisation: 15 February 1990
Date of latest renewal: 23 May 2003
Not applicable.
