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BACTERIOSTATIC SALINE FOR INJECTION

Active substance(s): SODIUM CHLORIDE

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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 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.
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.

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code:
V07AB

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

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

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 AUTHORISATION

Date of first authorisation: 15 February 1990
Date of latest renewal: 23 May 2003

10

DATE OF REVISION OF THE TEXT
08/09/2016

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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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