Bacteriostatic saline

Overdose

Not applicable.

Shelf life

5 years.

Contraindications

Not applicable.

Incompatibilities

Not applicable.

List of excipients

Benzyl alcohol

Sterile water for injection

Pharmaceutical form

Sterile Solution

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.

Therapeutic indications

To be used to reconstitute certain medicinal products.

Pharmacotherapeutic group

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

Pharmacodynamic properties

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

Pharmacokinetic properties

Not applicable.

Bacteriostatic Saline price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

Date of revision of the text

08/2016

Name of the medicinal product

Bacteriostatic Saline for Injection

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

Special precautions for storage

Store below 25°C. Discard any remaining solution after use.

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.

Marketing authorisation number(s)

PL 00057/1513

Fertility, pregnancy and lactation

Not applicable.

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.

Special warnings and precautions for use

Not applicable.

Effects on ability to drive and use machines

Not applicable.

Dosage (Posology) and method of administration

Extra-amniotic only.

Special precautions for disposal and other handling

No special requirements.

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 15 February 1990

Date of latest renewal: 23 May 2003

Interaction with other medicinal products and other forms of interaction

Not applicable.