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0.9% Sodium Chloride Injection

SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

0.9% Sodium Chloride Injection.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

No active substance(s).

3 PHARMACEUTICAL FORM

50 ml of 0.9 % Sodium Chloride Injection solvent for solution for infusion, a colourless solution presented in a polypropylene bag.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Diluent and carrier solution for injectable drugs, intended to be used exclusively in combination with Sporanox™ IV.

4.2 Posology and method of administration

To be used exclusively in combination with Sporanox IV.

4.3 Contraindications

Situations in which Sodium Chloride Injection cannot be used.

4.4


Special warnings and precautions for use

To be used exclusively in combination with Sporanox IV.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

The solution can be used during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic classification: B05X A03 (IV solution additives, electrolyte solutions)

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6.1 List of excipients

Sodium chloride, water for injections.

6.2 Incompatibilities

The solution is compatible with a wide range of drugs, including Sporanox IV.

6.3 Shelf life

0.9% Sodium Chloride Injection:    3 years

6.4 Special precautions for storage

0.9% Sodium Chloride Injection:

Do not store above 25°C. Do not freeze.

6.5 Nature and contents of container

Flexible polypropylene infusion bag, equipped with a flexible inlet and outlet port, and containing 52 to 56 ml of 0.9% Sodium Chloride Injection.

6.6 Special precautions for disposal

Opening sodium chloride bag:

Tear outer wrap at notch and remove infusion bag.

Flush procedure before the infusion

Before the infusion, the catheter should be flushed to avoid compatibility problems

between residual amounts of other drugs and itraconazole.

-    Fill the extension line provided with the kit containing the 0.2 pm in-line filter with sterile 0.9% sodium chloride solution and connect directly to the indwelling intravenous catheter.

-    Flush the extension line provided with the kit and indwelling intravenous catheter with sterile 0.9% sodium chloride solution.

7 MARKETING AUTHORISATION HOLDER

Janssen-Cilag Ltd.

50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00242/0345

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/07/1999 / 21/07/2009

10 DATE OF REVISION OF THE TEXT

04/04/2015