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STERILE SALINE SOLUTION (0.9%)

Active substance(s): NO ACTIVES PRESENT

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PRODUCT SUMMARY
1.

NAME OF THE MEDICINAL PRODUCT
Sterile Saline Solution (0.9%)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
None

3.

PHARMACEUTICAL FORM
Solution for injection.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
The diluent is supplied for reconstitution of an injectable preparation.

4.2.

Posology and method of administration
For administration according to instructions on the product to be reconstituted.

4.3.

Contra-indications
As for the product to be reconstituted.

4.4.

Special warnings and special precautions for use
As for the product to be reconstituted.

4.5.

Interactions with other medicinal products and other forms of interaction

As for the product to be reconstituted.

4.6.

Pregnancy and lactation
As for the product to be reconstituted.

4.7.

Effects on ability to drive and use machines
As for the product to be reconstituted.

4.8.

Undesirable effects
As for the product to be reconstituted.

4.9.

Overdose
As for the product to be reconstituted.

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
Sodium Chloride Ph. Eur.
Water for Injection Ph. Eur.

6.2.

Incompatibilities
As for the product to be reconstituted.

6.3.

Shelf life
48 months.

6.4.

Special precautions for storage
The diluent is supplied in combined pack for reconstitution of an injectable
preparation. The storage precautions on the pack will be that for the product
to be reconstituted.

6.5.

Nature and contents of container
0.5 ml Neutral type I glass ampoule or 5 ml and 25 ml neutral type I glass vial
with chlorobutyl stopper and aluminium overcaps.

6.6.

Instructions for use and handling
As for the product to be reconstituted.

ADMINISTRATION DATA

7.

MARKETING AUTHORISATION HOLDER

Smith Kline & French Laboratories Limited
Great West Road, Brentford, Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
or as for the product to be reconstituted.

8.

MARKETING AUTHORISATION NUMBER
PL 00002/0194

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/08/2008

10

DATE OF REVISION OF THE TEXT
07/08/2008

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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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