BACTERIOSTATIC WATER FOR INJECTION
Active substance(s): NOT APPLICABLE / NOT APPLICABLE / NOT APPLICABLE
NAME OF THE MEDICINAL PRODUCT
Bacteriostatic Water for Injections
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.
None. The product is intended as a diluent for Caverject Powder for Injection
(PL 00032/0188, 0203, 0214, 0227).
Posology and method of administration
Hypersensitivity to benzyl alcohol.
Special warnings and precautions for use
The solvent contains the preservative benzyl alcohol, which may cause anaphylactoid
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).
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
Benzyl alcohol can cross the placenta see section 4.4.
Effects on ability to drive and use machines
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
List of excipients
Benzyl alcohol Ph.Eur
Water for injection Ph.Eur
Special precautions for storage
Store below 25oC.
Nature and contents of container
1 ml pre-filled syringe with butyl rubber plunger stopper and tip cap
containing 1 ml of solution.
1 ml pre-filled syringe with butyl rubber plunger stopper, syringe tip cap,
tamper evident seal and locking device containing 1 ml of solution.
Special precautions for disposal and other handling
No special requirements.
MARKETING AUTHORISATION HOLDER
Kent, CT13 9NJ
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
15 March 1994 / 16 March 1999
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.