COMPOSITIONS :
Granisetron HCl Injection 3 mg/3 ml, each ml contains : Granisetron HCl equivalent to Granisetron 1 mg.
DESCRIPTIONS :
Granisetron HCl contains Granisetron HCl (equivalent to Granisetron) as an active ingredient is available in 1 mg/ml and 3 mg/3 ml injection.
INDICATIONS :
Granisetron HCl 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)
Adults
Intravenous :
- Prevention : A dose of 1 – 3 mg (10 – 40 mcg/kg) of Granisetron HCl 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) Granisetron HCl 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 Granisetron HCl may be administered, if required, at least 10 minutes apart. The maximum dose of Granisetron HCl to be administered over 24 hours should not exceed 9 mg.
Intramuscular :
Prevention and treatment : A dose of 3 mg of Granisetron HCl should be administered by the intramuscular route, 15 minutes prior to the start of chemotherapy. Two subsequent 3 mg doses of Granisetron HCl may be administered, if required, within a 24 hours period.
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 Granisetron HCl by the intramuscular route in children.
Radiotherapy induced nausea and vomiting (RINV)
Adults
Intravenous :
Prevention : A dose of 1 – 3 mg (10 – 40 mcg/kg) of Granisetron HCl 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.
Pediatrics
There is insufficient information to recommended use of Granisetron HCl in the prevention and treatment of RINV in children.
Post-operative nausea and vomiting (PONV)
Adults
Intravenous :
- Prevention : A dose of 1 mg (10 mcg/kg) of Granisetron HCl 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 Granisetron HCl 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 Granisetron HCl IV in one day.
Pediatrics
There is insufficient information to recommend use of Granisetron HCl in the prevention and treatment of postoperative nausea and vomiting in children.
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.
Granisetron HCl 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.
DRUG INTERACTIONS :
- Granisetron HCl did not induce or inhibit the cytochrome P450 drug metabolizing enzyme system or inhibit the activity of any well characterized P450 subfamilies.
- Hepatic enzyme induction with Phenobarbital resulted in an increase in total plasma clearance of intravenous Granisetron HCl of approximately one-quarter. Ketoconazole inhibited ring oxidation of Granisetron HCl. However, given the absence pf pK/pD relationship with Granisetron, these changes are believed to have no clinical consequences.
- Granisetron HCl has been safely administered in humans with benzodiazepines, neuroleptics and anti-ulcer medications, commonly prescribed with antiemetic treatments. Additionally, Granisetron HCl has shown no apparent drug interaction with emetogenic cancer chemotherapies.
- No specific interaction studies have been conducted in anesthetized patients, but Granisetron HCl has been safely administered with commonly used anesthetic and analgesic agents. In addition, the activity of the cytochrome P450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by Granisetron HCl.
ADVERSE REACTIONS :
Granisetron HCl has been well tolerated. In common with other drugs of this class, headache and constipation have been reported. Rare cases of hypersensitivity reactions, including rashes and anaphylaxis have been reported. Elevations in hepatic transaminases have been observed and at similar frequency in patients receiving comparator therapy.
PRESENTATIONS :
Granisetron HCl Injection 3 mg/3 ml Box, 10 ampoules @ 3 ml
Reg. No. GKL1902359443A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT AND DO NOT FREEZE
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
