Pharmacia Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221


Summary of Product Characteristics last updated on the eMC: 17/09/2009
SPC Bacteriostatic Saline for Injection


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1. NAME OF THE MEDICINAL PRODUCT

Bacteriostatic Saline for Injection


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Chloride, EP 0.9% w/v.


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3. PHARMACEUTICAL FORM

Solution


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

To be used to reconstitute certain medicinal products.


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4.2 Posology and method of administration

Extra-amniotic only.


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4.3 Contraindications

Not applicable.


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4.4 Special warnings and precautions for use

Not applicable.


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4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.


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4.6 Pregnancy and lactation

Not applicable.


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4.7 Effects on ability to drive and use machines

Not applicable.


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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.


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4.9 Overdose

Not applicable.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Not applicable.


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5.2 Pharmacokinetic properties

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Benzyl alcohol and water for injection.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

60 months.


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6.4 Special precautions for storage

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


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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.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Pharmacia Limited

Davy Avenue

Milton Keynes

MK5 8PH

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PL 0032/0149


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 February 1990

Date of renewal of authorisation: 23 May 2003


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10. DATE OF REVISION OF THE TEXT

April 2001

Ref: BA1_0

Legal category: POM



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22267/SPC/


Active Ingredients/Generics

 
   sodium chloride