Pharmaceutical particulars : מידע רוקחי

6.        Pharmaceutical Particulars
6.1       List of excipients

None.

6.2       Incompatibilities

Cefuroxime Medo 750 mg should not be mixed in the syringe with aminoglycoside antibiotics.

6.3       Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted solution:
Immediate use of the reconstituted solution is recommended.
Chemical and physical stability has been demonstrated:
- for 5 hours at 25°C and 48 hours at 2°C -8°C (in refrigerator) for the reconstituted solutions for intramuscular or intravenous injection with water for injections; - for 4 hours at 25°C and 24 hours at 2°C -8°C (in refrigerator) for the reconstituted solutions for intravenous infusion.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally be no longer than 24 hours at 2°C – 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.


6.4       Special precautions for storage
Store below 30ºC. Store in the original package in order to protect from light.

For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
6.5     Nature and contents of container

Type I clear glass vials having a nominal capacity of 15 ml that are sealed with a 20 mm bromobutyl rubber stopper and an aluminium cap.


Box of 10 vials.
6.6   Special precautions for disposal and other handling

Instructions for constitution

Table 4. Additional volumes and concentrations which may be useful when fractional doses are required.

Additional volumes and concentrations, which may be useful when fractional doses are required
Vial size       Routes of    Physical State  Amount of      Approximate administration                 water to be   cefuroxime added (mL)    concentration
(mg/mL)* *

750 mg powder for solution or suspension for injection or infusion
750 mg         intramuscular     suspension        3 mL            216 intravenous       solution bolus                               at least 6 mL   116 intravenous       solution infusion                            at least 6 mL* 116

* Reconstituted solution to be added to 50 or 100 mL of compatible infusion fluid (see information on compatibility, below)

** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/mL.

Compatibility

Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 4 hours at 25 ºC and 24 hours at 2°C -8°C (in refrigerator) in: 
0.18% w/v Sodium Chloride plus 4% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride Injection
5% Dextrose and 0.45% Sodium Chloride Injection
Potassium chloride (10 and 40 mEqL) in 0.9% Sodium chloride Injection 5% Dextrose Injection
10% Dextrose Injection
0.9% w/v Sodium chloride Injection
Ringers Injection
Ringers lactate Injection

Freshly prepared solution for IV administration is yellowish, while suspension for IM administration is almost white.
Solution can turn darker when standing but change of intensity of color of diluted solution does not affect safety of administration and effectiveness of medicinal product.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.     MANUFACTURER:
Medochemie LTD (Factory C), 2, Michael Erakleous, Agios Athanassios Industrial Area, 4101 Agios Athanassios, Limassol, Cyprus