Pharmaceutical particulars : מידע רוקחי

6.        Pharmaceutical Particulars
6.1      List of excipients

None.

6.2      Incompatibilities
Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions.

The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Cefuroxime - Vit . However, if required, for patients receiving sodium bicarbonate injection by infusion the Cefuroxime - Vit may be introduced into the tube of the giving set.

Cefuroxime - Vit should not be mixed in the syringe with aminoglycoside antibiotics.

6.3      Shelf life
Dry Powder
The expiry date of the product is indicated on the packaging materials.

Shelf life after dilution:
Chemical and physical stability has been demonstrated for 12 hours at 25oC and 48 hours at 2-8oC.

Shelf life after reconstitution:
Chemical and physical stability has been demonstrated for 8 hours at 25oC and 48 hours at 2-8oC.

From a microbiological point of view the reconstituted solution should be used immediately. If reconstituted product is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C unless the preparation has taken place under controlled and validated aseptic conditions.

6.4     Special precautions for storage

Do not store above 25ºC.
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

Clear Glass (type III) vials with bromobutyl rubber stopper, flip-off cap.
Each pack contains 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      Amount of         Approximate administration          State         water to be      cefuroxime added (mL)       concentration
(mg/mL)* *

750 mg powder for solution for injection or infusion
750 mg         intramuscular               suspension       3 mL                216  intravenous bolus           solution      at least 6 mL       116 intravenous infusion     solution      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.
Dextrose 5% containing 20 mEq KCl
Heparin (10 and 50 units/ml) in 0.9% NaCl 10 and 40 mEq KCl in 0.9% NaCl 0.9% w/v Sodium Chloride Injection
5% Dextrose Injection
0.18% w/v Sodium Chloride plus 4% Dextrose Injection
5% Dextrose and 0.9% w/v Sodium Chloride Injection
5% Dextrose and 0.45% Sodium Chloride Injection
5% Dextrose and 0.225% Sodium Chloride Injection
10% Dextrose Injection
10% Invert Sugar in Water for Injection
Ringer’s Injection
Lactated Ringer’s Injection
M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP (Hartmann’s Solution).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.     MANUFACTURER:
ACS DOBFAR S.P.A.,
Via Alessandro Fleming 2,
37135, Verona, Italy.