Ropenefix Caution For Usage

Direction for Reconstitution: Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes. Alternatively, Meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
For injection (Sterile Water for Injection 10 mL per 500 mg). This provides an approximate available concentration of 50 mg/mL. Constituted solutions are clear or pale yellow.
Meropenem FOR INJECTION USP for intravenous infusion maybe directly constituted with a compatible infusion fluid and then further diluted (50 to 200 mL) with the compatible infusion fluid, as needed.
Meropenem FOR INJECTION USP is compatible with the following infusion fluids: 0.9% sodium chloride, 5% or 10% glucose, 5% glucose with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride, 5% glucose with 0.02% sodium chloride, 5% glucose with 0.15% potassium chloride, 2.5% and 10% mannitol 5% glucose and Normosol-M. Also see Special Precautions for Storage as follows.
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 or 12 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.
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 3 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 vials may be directly constituted with 0.9% sodium chloride or 5% dextrose solution should be used immediately.
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.
Special Precautions for Storage: Store Meropenem powder for intravenous injection on infusion packs below 25°C.
To reduce microbiological hazard, solutions of Meropenem should be used as soon as practicable after reconstitution storage is necessary, hold at 2° to 8°C for not more than 24 hours, or the period shown in the following table, whichever is lesser. (See Table 6.)

Click on icon to see table/diagram/image

Solutions of Meropenem FOR INJECTION USP should not be frozen.
Incompatibilities: Meropenem is compatible with the solutions listed in Table 6 previously and should not be with or physically added to solutions containing other medicines.
Single use only.
Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.