Gravomit 3 mg

Indonesia • Ferron Par Pharmaceuticals

Indication

Granisetron is indicated for the prevention and treatment (control) of:

  • Acute and delayed nausea and vomiting associated with chemotherapy and radiotherapy
  • Postoperative nausea and vomiting

Composition

Each ml contains granisetron HCl 1,12 mg equivalent to granisetron 1 mg

Package

Box, 5 ampoules x 3 ml

Dosage Forms

Injection

ATC Classification

A04A

Warning

Alcohol
Consult Your Doctor
Safety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
Safe if Prescribed
This item is safe for use while operating heavy machinery.
Pregnancy
Consult Your Doctor
Safety of this item for use during pregnancy has not been established. Please consult your doctor.
Lactation
Consult Your Doctor
Safety of this item for use during lactation has not been established. Please consult your doctor.

Dosage

Chemotherapy induced nausea and vomitting (CINV)

Adults:
Intravenous:

  • Prevention: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered 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, prior to the start of chemotherapy.
  • Treatment: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered 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. Further treatment doses of granisetron may be administered, if required, at least 10 minutes apart. The maximum dose of granisetron to be administered over 24 hours should not exceed 9 mg.

Intramuscular:

  • Prevention and treatment: A dose of 3 mg of granisetron should be administered by the IM route, 15 minutes prior to the start of chemotherapy. Two subsequent 3 mg doses of granisetron may be administered, if required, within a 24 hours period.

Pediatrics:
Intravenous:
A dose of 10-40 mcg/kg body weight (up to 3 mg) should be administered as an intravenous 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 hours period if required. This additional dose should be administered until at least 10 minutes after the initial infusion.

Intramuscular:
Insufficient data are curently available to recommend the use of granisetron by the IM route in children.

Radiotherapy induced nausea and vomiting (RINV)

Adults:

  • Prevention: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered 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, prior to the start of radiotherapy.

Pediatrics:
There is insufficient information to recommend the use of granisetron in the prevention and treatment of RINV in children.

Post-operative nausea and vomiting (PONV)

Adults:

  • Prevention: A dose of 1 mg (10 mcg/kg) of granisetron should be administrated as a slow intravenous injection (over 30 seconds) prior to induction of anesthesia.
  • Treatment: A dose of 1 mg (10 mcg/kg) of granisetron should be administrated by slow intravenous injection (over 30 seconds). The maximum dose for patients undergoing anesthesia for surgery is a total dose of 3 mg of granisetron IV in one day.

Pediatrics:
There is insufficient data information to recommend the use of granisetron in the prevention and treatment of PONV in children.

* For detailed product information, see package insert.
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