RENOXITIN Powder for solution for injection / infusion Ref.[8247] Active ingredients: Cefoxitin

Posology

There are very limited clinical safety and efficacy data supporting the dose of cefoxitin. Therapeutic guidelines should be adhered to.

Based on these very limited clinical data and some supporting pharmacokinetic/pharmacodynamic data, the following may be appropriate:

Adults and adolescents

2g every 4-6 hours to a maximum of 12g/day.

Renal impairment

There are extremely little data on the administration of cefoxitin in patients with renal impairment. Great caution is advised when cefoxitin is administered to these patients. In adults with renal impairment, an initial loading dose of 2 g can be administered.

After the loading dose, the following recommendations can be used as guide for maintenance treatment:

* In patients on haemodialysis, the loading dose of 2 g should be given after each haemodialysis, and the maintenance treatment should be given as indicated in the table above.

Paediatric population

There are insufficient data to recommend a posology in children aged up to 11 years.

Method of administration

Cefoxitin may be administered by slow intravenous injection over a period of 3 to 5 minutes.

A solution of this medicinal product may also be administered by continuous intravenous infusion.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

Βeta-lactam antibiotics exposes to a risk of encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements) and, particularly, in case of overdose or reduced renal function.

3 years.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C and 2-8°C with Water for Injections. 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.

After dilution of the reconstituted solution with the solvents listed in section 6.6:

Do not refrigerate.

Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C.

From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of user.

This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Renoxitin is supplied in vials containing 1 g or 2 g cefoxitin as the sodium salt, closed with chlorobutyl rubber stopper and sealed with an aluminium capsule with polypropylene flip-off.

Renoxitin 1 g Powder for solution for injection is available in packs of 1, 5, 10, 20, 25, 50 and 100 vials.

Not all pack sizes may be marketed.

Cefoxitin may be reconstituted with 10 ml water for injections. Immediately after reconstitution, this Cefoxitin solution can be also added to 40 ml of the following solutions, frequently used in infusion(1g or 2g into 50 ml solution, corresponding to 20 to 40mg/ml):

• sodium chloride 0.9%,
• glucose 5% or 10%,
• mixed solution of glucose 5% and sodium chloride 0.9%,
• glucose 5% buffered with sodium bicarbonate 0.02%,
• glucose 5% supplemented with saline solution 0.2% or 0.45%,
• Ringer’s Lactate solution,
• mixed solution of glucose 5% and Ringer Lactate,
• mixed solution of fructose 5% or 10% in water for injections,
• fructose 10% solution in saline solution,
• Sodium lactate solution at M/6.

This medicine may be given together with other antibiotics (intravenously with separate syringes or infusions).

When this medicine is administered at the same time as another antibiotic, it is important that the antibiotics are not mixed in the same syringe or infusion.

Reconstitution

Renoxitin should be reconstituted with water for injections: 1 g is soluble in 2 ml. Although, Renoxitin is very soluble, for intravenous use it is preferable to add 10 ml of water for injections to the 1 g vial or to the 2 g vial. It should be shaken to dissolve and then withdraw the entire contents of the vial into a syringe.

Dilution

The reconstituted solution should be diluted with the solvents mentioned above in section 6.6: add around 40 ml of the solvent to the reconstituted solution in order to reach a total volume of 50 ml.

The product should be used immediately after reconstitution/dilution.

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