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Product Code: 412365
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SUTENT 12.5 mg capsules ( Sunitinib )

The active substance is granisetron.

Each ml solution for injection contains 1 mg of granisetron (as the hydrochloride).

 

Kytril solution for injection is indicated in adults for the prevention and treatment of

- acute nausea and vomiting associated with chemotherapy and radiotherapy.

- post-operative nausea and vomiting.

Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.

Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.

 

Posology

Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV)

Prevention (acute and delayed nausea)

A dose of 1-3 mg (10-40 μg/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy. The solution should be diluted to 5ml per mg.

 

Treatment (acute nausea)

A dose of 1-3 mg (10-40 μg/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion and administered over 5 minutes. The solution should be diluted to 5ml per mg. Further maintenance doses of Kytril solution for injection may be administered at least 10 minutes apart. The maximum dose to be administered over 24 hours should not exceed 9 mg.

 

Combination with adrenocortical steroid

The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical steroid e.g. by 8-20 mg dexamethasone administered before the start of the cytostatic therapy or by 250 mg methyl-prednisolone administered prior to the start and shortly after the end of the chemotherapy.

 

Paediatric population

The safety and efficacy of Kytril solution for injection in children aged 2 years and above has been well established for the prevention and treatment (control) of acute nausea and vomiting associated with chemotherapy and the prevention of delayed nausea and vomiting associated with chemotherapy. A dose of 10-40 μg/kg body weight (up to 3 mg) should be administered as an i.v. infusion, diluted in 10-30 ml infusion fluid and administered over 5 minutes prior to the start of chemotherapy. One additional dose may be administered within a 24 hour-period if required. This additional dose should not be administered until at least 10 minutes after the initial infusion.

 

Post-operative nausea and vomiting (PONV)

A dose of 1 mg (10 μg/kg) of Kytril solution for injection should be administered by slow intravenous injection. The maximum dose of Kytril to be administered over 24 hours should not exceed 3 mg.

For the prevention of PONV, administration should be completed prior to induction of anaesthesia.

 

 

Pregnancy

There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measureit is preferable to avoid the use of granisetron during pregnancy.

 

Breastfeeding

It is unknown whether granisetron or its metabolites are excreted in human milk. As a precautionary measure, breast-feeding should not be advised during treatment with Kytril.

 

Fertility

In rats, granisetron had no harmful effects on reproductive performance or fertility.

The active substance is granisetron.

Each ml solution for injection contains 1 mg of granisetron (as the hydrochloride).

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