GRANITROX Injection

Granisetron 3 mg / 3 ml

Category:

COMPOSITIONS :

Granitrox® Injection 3 mg/3 ml, each ml contains : Granisetron HCl equivalent to Granisetron 1 mg.

 

DESCRIPTIONS : 

Granitrox® contains Granisetron HCl (equivalent to Granisetron) as an active ingredient is available in 1 mg/ml and 3 mg/3 ml injection.

 

INDICATIONS : 

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

  • Acute and delayed nausea and vomiting associated with chemotherapy and radiotherapy.
  • Post-operative nausea and vomiting.

 

DOSAGE AND ADMINISTRATIONS : 

Standard dosage

Chemotherapy induced nausea and vomiting (CINV)

  1. Adults

Intravenous :

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

Intramuscular :

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

2. Pediatrics

Intravenous :
A dose of 10 – 40 mcg/kgBW (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 not be administered until at least 10 minutes after the initial infusion.

Intramuscular :
Insufficient data are currently available to recommend the use of Granitrox® by the intramuscular route in children.

Radiotherapy induced nausea and vomiting (RINV)

  1. Adults

Intravenous :

Prevention : A dose of 1 – 3 mg (10 – 40 mcg/kg) of Granitrox® 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 be start of radiotherapy.

2. Pediatrics
There is insufficient information to recommended use of Granitrox® in the prevention and treatment of RINV in children.

Post-operative nausea and vomiting (PONV)

  1. Adults

Intravenous :

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

2. Pediatrics
There is insufficient information to recommend use of Granitrox® in the prevention and treatment of postoperative nausea and vomiting in children.

3. Maximum dose and duration treatment
Two doses (2 mg) in one day.

Special dosage instruction

  • Geriatrics : No dosage adjustments required.
  • Renal impairment : No dosage adjustments required.
  • Hepatic impairment : No dosage adjustments required.

Instructions for use, handling and disposal

Preparation of infusion :

  • For adults : The appropriate dose is diluted with infusion fluid, to a total volume of 20 – 50 ml in any of the following solutions : 0.9 % sodium chloride and 5% Dextrose.
  • For children : The appropriate dose is diluted with infusion fluid (as for adults) to a total volume of 10 – 30 ml.

Granitrox® has been shown to be stable for at least 24 hours when stored at ambient temperature in any of following solutions : 0.9 % sodium chloride and 5% Dextrose.

 

OVERDOSAGE : 

There is no specific antidote for Granisetron HCl. In the case of overdosage with Granisetron HCl, symptomatic treatment should be given. Overdosage of up to 38.5 mg of Granisetron HCl as a single injection has been reported without symptoms or only the occurrence of a slight headache.

 

CONTRAINDICATIONS : 

In patient with known hypersensitivity to Granisetron or its excipients.

 

WARNINGS AND PRECAUTIONS : 

  • As Granisetron HCl may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored closely following administration of Granisetron HCl.
  • Pregnancy and lactation : There are no studies in pregnant women and it is not known whether Granisetron is excreted in human milk. Use of Granisetron HCl during pregnancy or lactation should be limited to situations where the potential benefit to the mother justifies the potential risk to the fetus or nursing infant.
  • Effects on ability to drive and use machines : There are no data on the effect of Granisetron HCl on the ability to drive or use machinery.

 

PRESENTATIONS :

Granitrox® Injection 3 mg/3 ml             Box, 5 ampoules @ 3 ml              Reg. No DKL1902359343A1

 

STORAGE :

STORE BELOW 30°C, PROTECT FROM LIGHT AND DO NOT FREEZE

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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