GRANISETRON

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 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 5 ml per mg. Treatment (acute nausea) A dose of 1-3 mg (10-40 μg/kg) of Granisetron 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 5 ml per mg. Further maintenance doses of Granisetron solution for injection may be administered al least 10 minutes apart. The maximum dose to be administered over 24 hours should not exceed 9 mg. 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 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.

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 (10μg/kg) of Granisetron solution for injection 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. 1 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.

). 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. 6.

Summary of the safety profile The most frequently reported adverse reactions for Granisetron are headache and constipation which may be transient. 5). Tabulated list of adverse reactions The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with granisetron and other 5-HT3 antagonists.

The frequencies used in the table below are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to < 1/1,000) and very rare (<1/10,000). 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration. As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.

In patients with pre-existing arrhythmias or cardiac conduction disorders this might lead to clinical consequences. 5). g. dolasetron, ondansetron) has been reported This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially 'sodium free' Serotonin syndrome There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).

Appropriate observation of patients for serotonin syndrome-like symtoms is advised.

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