GRANTRYL Film-coated tablet Ref.[51214] Active ingredients: Granisetron

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

4.1. Therapeutic indications

GRANTRYL is indicated for the prevention of:

  • acute and delayed nausea and vomiting associated with chemotherapy (CINV) and radiotherapy (RINV).

4.2. Posology and method of administration

Posology

Adults

Chemotherapy Induced Nausea and Vomiting (CINV)

Prevention:

The dose of GRANTRYL is 1 mg twice a day or 2 mg once a day, for up to one week following chemotherapy. The first dose of GRANTRYL should be administered within one hour before the start of therapy.

Radiotherapy Induced Nausea and Vomiting (RINV)

The dose of GRANTRYL is 2 mg once a day, for up to one week following radiotherapy. The first dose of GRANTRYL should be administered within one hour before the start of therapy.

Special populations

Geriatrics

No dosage adjustments required.

Renal impairment

No dosage adjustments required.

Hepatic Impairment

No dosage adjustments required.

Although present experience indicates that no dosage adjustment is required, care should be exercised when administering GRANTRYL to elderly patients and patients with renal or hepatic impairment.

Paediatric population

GRANTRYL is contraindicated in children under the age of 2 years (see section 4.3). There is insufficient information to recommend use of GRANTRYL in the prevention of RINV in children.

Method of administration

For oral administration

4.9. Overdose

Symptoms

Headaches may occur. Granisetron, as GRANTRYL, may prolong the QT interval.

Treatment

There is no specific antidote for GRANTRYL. In the case of overdosage, symptomatic and supportive treatment should be given. ECG monitoring is recommended in case of overdose with GRANTRYL.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store at or below 25°C protected from light and moisture.

Keep in original packaging until required for use.

6.5. Nature and contents of container

1, 5, 10 and 100 film-coated tablets are packed in a white opaque polyvinyl chloride film blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

Not all pack sizes are necessarily marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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