SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Bacteriostatic Water for Injections

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

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.

3    PHARMACEUTICAL FORM

Sterile solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

None. The product is intended as a diluent for Caverject Powder for Injection (PL 00032/0188, 0203, 0214, 0227).

4.2 Posology and method of administration

Intracavernosal injection

4.3 Contraindications

Hypersensitivity to benzyl alcohol.

4.4 Special warnings and precautions for use

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).

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

Benzyl alcohol can cross the placenta see section 4.4.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

None stated.

5.1 Pharmacodynamic properties

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

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.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzyl alcohol Ph.Eur Water for injection Ph.Eur

6.2 Incompatibilities

None stated

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25^oC.

6.5 Nature and contents of container

1 ml pre-filled syringe with butyl rubber plunger stopper and tip cap containing 1 ml of solution.

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

6.6 Special precautions for disposal and other handling

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Pfizer Limited Ramsgate Road Sandwich Kent, CT13 9NJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00057/0934

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 March 1994 / 16 March 1999

10 DATE OF REVISION OF THE TEXT

29/10/2014