Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical Particulars

6.1 List of excipients

None.
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

Dry Powder: The expiry date of the product is indicated on the packaging materials.

The reconstituted solution for injection remains chemically and physically stable for 24 hours at 2°C - 8°C.

The diluted solution for infusion will retain potency for up to 24 hours at room temperature

From the microbiological point of view, the product should be used immediately after opening/reconstitution/dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4     Special precautions for storage

Store below 25°C. Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5     Nature and contents of container

Glass vial with only moderate hydrolytic resistance (type III), tightly closed with a bromobutyl rubber stopper and sealed with an aluminum cap. Each vial contains 750 mg of cefuroxime. The carton contains 1, 5 or 55 vials.

Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling
Preparation of solution for intramuscular administration
Dissolve 750 mg of powder in 3 ml of water for injections.
Preparation of a solution for intravenous administration
Dissolve 750 mg of powder in 6 ml of water for injections.
The reconstituted solution is yellowish, without visible particles.

Instructions for constitution

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

Vial size   Routes of              Physical      Physical     Amount of Approximate administration         State         State        water to be cefuroxime added (mL) concentration
(mg/mL)* *
750 mg      intramuscular          suspension suspension 3 mL              216 Intravenous bolus      solution     solution     at least 6    116 mL intravenous infusion solution       solution     at least 6    116 mL*
* 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 the reconstitution medium is increased due to 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 24 hours at room temperature in:

0.9% Sodium Chloride Injection;
5% Glucose Injection;
0.18% Sodium Chloride plus 4% Glucose Injection;
5% Glucose and 0.9% Sodium Chloride Injection;
5% Glucose and 0.45% Sodium Chloride Injection;
5% Glucose and 0.225% Sodium Chloride Injection;
10% Glucose Injection;
10% Invert Sugar in Water for Injection;
Ringer’s Injection;
Lactated Ringer’s Injection;
M/6 Sodium Lactate Injection;
Hartmann’s Solution.

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

7. MANUFACTURER:
PJSC SIC “Borshchahivskiy CPP”, Kyiv, Ukraine