GRANTRYL Solution for injection Ref.[51215] Active ingredients: Granisetron

Chemotherapy induced nausea and vomiting (CINV):

Posology

Adults

Prevention

A dose of 1-3 mg (10–40 µg/kg) of GRANTRYL should either be administered either as a slow intravenous injection (over 30 seconds), or as an intravenous infusion diluted in 20–50 ml infusion fluid (see Preparation of dosage form) and administered over 5 minutes, prior to the start of chemotherapy.

Treatment

A dose of 1-3 mg (10–40 µg/kg) of GRANTRYL should be administered either as a slow intravenous injection (over 30 seconds), or as an intravenous infusion diluted in 20–50 ml infusion fluid (see Preparation of dosage form) and administered over 5 minutes. Further maintenance doses of GRANTRYL may be administered, if required, at least 10 minutes apart. The maximum dose of GRANTRYL to be administered over 24 hours should not exceed 9 mg.

Paediatrics

GRANTRYL is contra-indicated in children under 2 years of age (see CONTRAINDICATIONS).

A dose of 10–40 µg/kg body weight (up to 3 mg) should be administered as an intravenous 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.

Radiotherapy induced nausea and vomiting (RINV):

Adults

Prevention

A dose of 1-3 mg (10–40 µg/kg) of GRANTRYL should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20-50 ml infusion fluid and administered over 5 minutes, prior to the start of radiotherapy.

Paediatrics

Due to lack of data, GRANTRYL is not recommended for prevention and treatment of RINV in children.

Post-operative nausea and vomiting (PONV):

Adults

Prevention

A dose of 1 mg (10 µg/kg) of GRANTRYL should be administered as a slow intravenous injection (over 30 seconds) prior to induction of anaesthesia

Treatment

A dose of 1 mg (10 µg/kg) of GRANTRYL should be administered as a slow intravenous injection (over 30 seconds). The maximum dose for patients undergoing anaesthesia for surgery is a total dose of 3 mg of GRANTRYL intravenous in one day.

h3.Paediatrics

Due to lack of data, GRANTRYL is not recommended for prevention and treatment of PONV in children.

Special dosage instructions

Elderly patients (65 yers of age or older)

No dosage adjustments required.

Renal impairment

No dosage adjustment required.

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, GRANTRYL should be used with a certain amount of caution in this patient group. See Pharmacokinetics.

Method of administration

Preparation of dosage form

Use immediately after reconstitution. Solutions should not be stored for longer than 24 hours at a temperature of 2–8°C unless prepared under controlled aseptic conditions.

Adults

GRANTRYL may be diluted with 20 to 50 ml of the following infusion fluids:

• 0,9% m/v sodium chloride
• 0,18% m/v sodium chloride and 4% m/v glucose
• 5% m/v glucose
• Hartmann’s solution
• Sodium lactate
• 10% m/v mannitol

Children (>2 years)

GRANTRYL may be diluted with 10 to 30 ml of the following infusion fluids:

• 0,9% m/v sodium chloride
• 0,18% m/v sodium chloride and 4% m/v glucose
• 5% m/v glucose
• Hartmann’s solution
• Sodium lactate
• 10% m/v mannitol

Headache may occur. There is no specific antidote for granisetron. In the case of over-dosage, symptomatic and supportive treatment should be given.

24 months.

Store in the original packaging (in the carton) at or below 30°C. Protect from light.

Diluted solution: Use immediately after reconstitution. Solutions should not be stored for longer than 24 hours at a temperature of 2–8°C unless prepared under controlled aseptic conditions. Any unused solution should be discarded after 24 hours.

KEEP MEDICINE OUT OF THE REACH OF CHILDREN.

Identification

GRANTRYL 1 mg/1 ml: A clear Type 1 glass ampoule containing a clear colourless solution. The content allows withdrawal of 1 ml.

GRANTRYL 3 mg/3 ml: A clear Type 1 glass ampoule containing a clear colourless solution. The content allows withdrawal of 3 ml.

Presentations

GRANTRYL 1 mg/1 ml: Packs of 5 × 1 ml Type I glass ampoules, packed in a PVC tray, contained in a cardboard carton

GRANTRYL 3 mg/3 ml: Packs of 5 × 5 ml Type I glass ampoules, packed in a PVC tray, contained in a cardboard carton.

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