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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ Telephone: +44 (0)1304 616 161 Fax: +44 (0)1304 656 221 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 17/09/2009

SPC	Bacteriostatic Saline for Injection

Table of Contents

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 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

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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

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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

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Link to this document from your website: http://emc.medicines.org.uk/medicine/22267/SPC/Bacteriostatic Saline for Injection/

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Legal Categories

	POM – Prescription Only Medicine
	P – Pharmacy
	GSL – General Sales List
	CE Mark

Active Ingredients/Generics

sodium chloride

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