Section 6.3

Shelf life text replaced with new text.

After reconstitution:

Intravenous bolus injection administration

A solution for bolus injection is prepared by dissolving the drug product Meronem 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 controlled room temperature (15-25ºC).

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 Meronem 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 6 hours at controlled room temperature (15-25ºC) or 24 hours at 2-8ºC. The prepared solution should, if refrigerated, be used within 2 hours after it has left the refrigerator. 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 Meronem in 5% glucose (dextrose) solution should be used immediately, i.e. within one hour following reconstitution.

Section 10

Date of revision updated to 21 November 2011.

Section 1

The word TRADE removed from title so title now reads NAME OF MEDICINAL PRODUCT

Section 2

Following text removed from table: “Excipeint: Anhydrous sodium carbonate 104mg 208mg”

Following sentence removed: “For each gram of meropenem(anhydrous potency) the vial contains 90mg (3.9mmol) of sodium”

Following new text added below table: “For excipients, see 6.1 ”

Section 3

Previous sentence “Powder for constitution for intravenous administration” removed and replaced with the following new text: “Powder for solution for injection of infusion.”

Section 4.4

Following new text added 8^th paragraph: Meronem may reduce serum valproic acid levels.  Sub-therapeutic levels may be reached in some patients. 

Last paragraph last sentence removed: Keep all medicines away from children.

Section 4.8

Text is now in-line with MedDRA frequency descriptor table, aligning frequency with system order class and MedDRA terminology.

New text added to table under common frequency “Increases in serum”

New text also added under not known frequency “Haemolytic anaemia”

The following text, stated after the side effects table, was deleted: “For convulsions, the incidence is calculated on exposure in clinical trials with infections other than meningitis however a casual link with Meronem has not been established” And replaced with following new text:

For convulsions, the incidence is calculated on exposures in patients with infections other than meningitis.

Section 4.9

Following new sentence added to the 1^st paragraph: Limited post-marketing experience indicates that adverse events following overdosage are consistent with the adverse event profile described in section 4.8.

Section 6.2

Reformatted section text now not in a table.

Section 6.4

Content of table not changed table reformatted and following new text added below table: Solutions of Meronem should not be frozen.

Section 10