Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Meropenem Fresenius 500 mg: sodium carbonate
Meropenem Fresenius 1000 mg: 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 3 hours at up to 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.
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% 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 6 hours at up to 25°C or 24 hours under refrigerated conditions (2-8°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.

Reconstituted solution of the product in 5% dextrose solution should be used immediately.

The constituted solutions should not be frozen.
6.4 Special precautions for storage
Store below 30°C.
Do not freeze. Keep in the original package to protect from light.

6.5 Nature and contents of container

Meropenem Fresenius 500 mg
20 ml Type III glass vial with stopper & cap (bromobutyl rubber stopper with an aluminium cap)
Meropenem Fresenius 1000 mg
20 ml Type III glass vial with stopper & cap (bromobutyl rubber stopper with an aluminium cap)
The medicinal product is supplied in pack sizes of 1 or 10 vials.
Not all pack sizes may be marketed.

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% dextrose 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.

7. LICENSE HOLDER

NEOPHARM (ISRAEL) 1996 LTD
HASHILOACH 6, POB 7063 PETACH TIQVA 4917001