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BACTERIOSTATIC SALINE FOR INJECTION

Active substance(s): SODIUM CHLORIDE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bacteriostatic Saline for Injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride, EP 0.9% w/v.

3

PHARMACEUTICAL FORM
Solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To be used to reconstitute certain medicinal products.

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.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not applicable.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Benzyl alcohol and water for injection.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
60 months.

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 fliptop aluminium cap. Vials contain 18.5 ml or 50 ml.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00057/1513

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 15 February 1990
Date of renewal of authorisation: 24 October 1997

10

DATE OF REVISION OF THE TEXT
30/04/2014

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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.

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