Bacteriostatic Water for Injection: Clinical Particulars
Active ingredient: no active ingredients
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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 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
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. 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 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
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
10/2014
BW 3_4