Bacteriostatic Water for Injections

Bacteriostatic Water for Injections

Excipients with known effect: benzyl alcohol, see sections 4.3 and 4.4.Each 1 ml vial contains 9 mg/ml benzyl alcohol.For the full list of excipients see section 6.1

Sterile solution.

None. The product is intended as a diluent for Caverject Powder for Injection (PL 00057/0944, 0941, 0942, 0943).

Intracavernosal injection

Hypersensitivity to benzyl alcohol.

The solvent contains the preservative benzyl alcohol, which may cause anaphylactoid reactions.Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardio-vascular failure and haematological anomalies (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).Premature and low-birth weight infants may be more likely to develop toxicity.Benzyl alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).Benzyl alcohol can cross the placenta and has the potential for toxicity in the newborn. Medicines containing benzyl alcohol should therefore be avoided in pregnant women at or near term (see section 4.6).

None stated.

Benzyl alcohol can cross the placenta (see section 4.4).

None stated.

None stated.

None stated.

None stated.

None stated.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this Summary of Product Characteristics.

Benzyl alcohol Ph.EurWater for injection Ph.Eur

None stated

3 years

Store below 25°C.

1 ml pre-filled syringe with butyl rubber plunger stopper and tip cap containing 1 ml of solution.or1 ml pre-filled syringe with butyl rubber plunger stopper, syringe tip cap, tamper evident seal and locking device containing 1 ml of solution.

No special requirements.

Pfizer LimitedRamsgate RoadSandwichKent, CT13 9NJUnited Kingdom

PL 00057/0934

Date of first authorisation: 29 March 2012Date of latest renewal:

10/2014BW 3_4