GRANISETRON Concentrate for solution for injection or infusion Ref.[8216] Active ingredients: Granisetron

Posology

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

Prevention (acute and delayed nausea and vomiting)

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

Treatment (acute nausea and vomiting)

A dose of 1–3 mg (10–40 µg/kg) of Granisetron 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 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 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. A dose of 10–40 µg/kg body weight (up to 3 mg) should be administered as an IV 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 Granisetron 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 section 5.1, 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.

Special populations

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 section 5.2).

Method of administration

Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20-50 ml infusion fluid and administered over 5 minutes.

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

There is no specific antidote for granisetron. In the case of overdose with the injection or infusion, symptomatic treatment should be given. Doses of up to 38.5 mg of granisetron as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.

3 years.

The product should be used immediately after opening. For single use only. Discard any remaining portion.

Shelf life after Dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in normal indoor illumination protected from direct sunlight. From a microbiological point of view, the product should be used immediately. If 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 dilution has taken place in controlled and validated aseptic conditions.

This product does not require any special temperature storage conditions.

Keep the ampoules in the outer carton in order to protect from light.

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

1 and 3 ml colourless ampoules.

Pack sizes: 5 × 1 ml, 10 × 1 ml, 5 × 3 ml and 10 × 3 ml

Not all pack sizes may be marketed.

Preparing the infusion

Adults

The contents of a 1 ml ampoule can be diluted to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted to a volume of 15 ml.

Granisetron can also be diluted in 20-50 ml compatible infusion fluid and then given over 5 minutes as an intravenous infusion in any of the following solutions:

0.9% w/v sodium chloride injection
0.18% w/v sodium chloride and 4% glucose injection
5% w/v glucose injection
Hartmann’s solution
1.87 % w/v sodium lactate injection
10% mannitol injection
1.4% w/v sodium hydrogen carbonate injection
2.74% w/v sodium hydrogen carbonate injection
4.2% w/v sodium hydrogen carbonate injection

No other diluents should be used.

Children 2 years of age and older

To prepare the dose of 10-40 µg/kg, the appropriate volume is withdrawn and diluted with infusion fluid (as for adults) to a total volume of 10-30 ml.

As a general precaution, Granisetron should not be mixed in solution with other drugs

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