Granisetron Kabi

Granisetron Kabi Dosage/Direction for Use

granisetron

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Dosage/Direction for Use
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 Granisetron Kabi 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 5 ml per mg.
Treatment (acute nausea): A dose of 1-3 mg (10-40 μg/kg) of Granisetron Kabi 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 5 ml per mg. Further maintenance doses of Granisetron Kabi 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 Granisetron Kabi 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 to 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 Granisetron Kabi should be administered by slow intravenous injection. The maximum dose of Granisetron 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.
Paediatric population: Currently available data are described in Pharmacology: Pharmacodynamics under Actions but no recommendation on a posology can be made. There is insufficient clinical evidence to recommend administration of the solution for injection to children in prevention and treatment of Post-operative nausea and vomiting (PONV).
Elderly and renal impairment: There are no special precautions required for its use in either elderly patients or those patients with renal or hepatic impairment.
Hepatic impairment: There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders. On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Administration may be either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes.
For instructions on dilution of the medicinal product before administration, see Cautions for Usage.
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