Summary of Product Characteristics Updated 03-May-2019 | Pfizer Limited
Bacteriostatic Saline for Injection
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 Prostin E2 Sterile Solution 10 mg/ml.
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
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.
Date of first authorisation: 15 February 1990
Date of latest renewal: 23 May 2003
Ref: BA 4_2
Ramsgate Road, Sandwich, Kent, CT13 9NJ
+44 (0)1304 616161
+44 (0)1304 616 161