Pharmaceutical particulars : מידע רוקחי

6.        PHARMACEUTICAL PARTICULARS

6.1       List of excipients
Sodium carbonate
6.2       Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3       Shelf life
The expiry date of the product is indicated on the packaging materials.

After reconstitution:

Intravenous bolus injection administration
A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 2 hours at 25°C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

The constituted solutions should not be frozen.
Intravenous infusion administration
A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% glucose (dextrose) solution for infusion to a final concentration of 1 to 20 mg/ml. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 4 hours at 25°C.

Constituted solutions of Meropenem/ANFARM IV in 5% glucose (dextrose) solution should be used immediately, i.e. within one hour following reconstitution.

The constituted solutions should not be frozen.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

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6.4       Special precautions for storage
Do not store above 25°C.
Protect from light.

Do not freeze the reconstituted solution.

For storage conditions after reconstitution of the medicinal product, see section 6.3.


6.5       Nature and contents of container
Uncoloured glass vials type III having a capacity of 20 ml stoppered with bromobutyl rubber  stoppers having a diameter of 20 mm.

The medicinal product is supplied in pack size of 10 vials.


6.6       Special precautions for disposal and other handling
Injection
Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.

Infusion
For intravenous infusion meropenem vials may be directly constituted with 0.9% sodium chloride or 5% glucose solutions for infusion.

Each vial is for single use only.

Standard aseptic techniques should be used for solution preparation and administration.
The solution should be shaken before use.

Any unused product or waste material should be disposed of in accordance with local requirements.