Vaxcel Granisetron

Vaxcel Granisetron Dosage/Direction for Use

granisetron

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Dosage/Direction for Use
Chemotherapy Induced Nausea and Vomiting (CINV): Adults: Intravenous: Prevention: A dose of 1 - 3mg (10 - 40mcg/kg) of Granisetron should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50ml infusion fluid and administered over 5 minutes, prior to the start of chemotherapy.
Treatment: A dose of 1 - 3mg (10 - 40mcg/kg) of Granisetron should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50ml 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 9mg.
Intramuscular: Prevention and Treatment: A dose of 3mg of Granisetron should be administered by the intramuscular route, 15 minutes prior to the start of chemotherapy. Two subsequent 3mg doses of Granisetron may be administered, if required, within a 24 hour period.
Pediatrics: Intravenous: A dose of 10 - 40mcg/kg body weight (up to 3mg) should be administered as an intravenous infusion, diluted in 10 to 30ml 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.
Intramuscular: Insufficient data are currently available to recommend the use of Granisetron by the intramuscular route in children.
Radiotherapy Induced Nausea and Vomiting (RINV): Adults: Intravenous: Prevention: A dose of 1 - 3mg (10 - 40mcg/kg) of Granisetron should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50ml 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 prevention and treatment of RINV in children.
Post-operative Nausea and Vomiting (PONV): Adults: Intravenous: Prevention: A dose of 1mg (10mcg/kg) of Granisetron should be administered as a slow intravenous injection (over 30 seconds) prior to induction of anesthesia.
Treatment: A dose of 1mg (10mcg/kg) of Granisetron should be administered by slow intravenous injection (over 30 seconds). The maximum dose for patients undergoing anesthesia for surgery is a total dose of 3mg of Granisetron i.v. in one day.
Pediatrics: There is insufficient information to recommend the use of Granisetron in prevention and treatment of postoperative nausea and vomiting in children.
Special Dosage Instructions: Geriatrics: No dosage adjustments required.
Renal impairment: No dosage adjustments required.
Hepatic impairment: No dosage adjustments required.
Method of administration: Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 - 50 ml infusion fluid and administered over 5 minutes.
Preparation of infusion: For adults: The appropriate dose can be diluted with infusion fluid, to a total volume of 20 to 50ml in any of the following compatible solutions, and stable for up to 24 hours at room temperature (25±2°C), beyond that any unused solution should be discarded: 0.9% sodium chloride injection; 0.18% sodium chloride + 4% dextrose; 5% dextrose; Hartmann's solution; Sodium lactate; Mannitol.
For children: The appropriate dose is diluted with infusion fluid (as for adults) to a total volume of 10 to 30ml.
Special Remarks: Admixtures of granisetron hydrochloride and dexamethasone sodium phosphate are compatible at concentrations of 10 to 60 μg/ml granisetron and 80 to 480 μg/ml dexamethasone sodium phosphate in either 0.9% sodium chloride or 5% glucose intravenous infusion fluids. The admixture will be stable for 24 hours.
Route of Administration: For intravenous injection & infusion.
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