Bacteriostatic Saline for Injection: Clinical Particulars
Active ingredient: sodium chloride
- 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
- 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 Saline for Injection
2. Qualitative and quantitative composition
Each vial contains sodium chloride, 0.9% w/v.
Excipient(s) with known effect
Each vial contains benzyl alcohol, 0.9% w/v.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile Solution
4. Clinical particulars
4.1 Therapeutic indications
To be used to reconstitute Prostin E2 Sterile Solution 10 mg/ml.
4.2 Posology and method of administration
Extra-amniotic only.
4.3 Contraindications
Not applicable.
4.4 Special warnings and precautions for use
Not applicable.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Fertility, pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Benzyl alcohol is contained in the diluent and has been reported to be associated with a fatal "gasping syndrome" in premature infants.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Not applicable.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code: V07AB
5.2 Pharmacokinetic properties
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Benzyl alcohol
Sterile water for injection
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Store below 25°C. Discard any remaining solution after use.
6.5 Nature and contents of container
Type I flint glass vials and rubber closures (EP) which are sealed with a flip-top aluminium cap. Vials contain 18.5 ml or 50 ml.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
8. Marketing authorisation number
PL 00057/1513
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 15 February 1990
Date of latest renewal: 23 May 2003
10. Date of revision of the text
04/2020
Ref: BA 4_2