This information is intended for use by health professionals

1. Name of the medicinal product

Bacteriostatic Water for Injections

2. Qualitative and quantitative composition

Excipient with known effect

Each 1 ml vial contains 9.45 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 00057/0944, 0941, 0942, 0943).

4.2 Posology and method of administration

Intracavernosal injection

4.3 Contraindications

Hypersensitivity to benzyl alcohol.

4.4 Special warnings and precautions for use

Bacteriostatic Water for Injections contains benzyl alcohol (see section 2).The preservative benzyl alcohol may cause hypersensitivity reactions.

Intravenous administration of benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Benzyl alcohol containing formulations should only be used in neonates if it is necessary and if there are no alternatives possible. Premature and low-birth weight neonates may be more likely to develop toxicity. Benzyl alcohol containing formulations should not be used for more than 1 week in children under 3 years of age unless necessary. If use of a benzyl alcohol-containing formulation of Bacteriostatic Water for Injections is necessary, it is important to consider the combined daily metabolic load of benzyl alcohol from all sources, especially in patients with liver or kidney impairment, as well as in pregnant or breast-feeding women, because of the risk of accumulation and toxicity (metabolic acidosis).

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

Pregnancy

Bacteriostatic Water for Injections contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta (see section 4.4).

Breastfeeding

Bacteriostatic Water for Injections contains benzyl alcohol as a preservative. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant (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. Pharmacological properties
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 (E1519) 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°C.

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

Date of first authorisation: 29 March 2012

Date of latest renewal:

10. Date of revision of the text

12/2020