Summary of Product Characteristics (SmPC) - Bacteriostatic water for injection
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 solution for injection/ Alprostadil powder for solution for injection (PL 00057/0941, 0942).
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 25oC.
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
20/09/2024