GRANODEX SOLUTION FOR INJECTION 1MG/ML

PT. Ferron Par Pharmaceuticals (INDONESIA REP OF)🇸🇬 Health Sciences Authority

Approval Date: Sep 1, 2022
Approval ID: 0f9b55109fe525ff
Company: PT. Ferron Par Pharmaceuticals (INDONESIA REP OF)
Type: Therapeutic

Approval Details

Approval Id: 0f9b55109fe525ff
Drug Name: GRANODEX SOLUTION FOR INJECTION 1MG/ML
Product Name: GRANODEX SOLUTION FOR INJECTION 1MG/ML
Approval Number: SIN16589P
Approval Date: 2022-09-01
Registrant: GLORIOUS DEXA SINGAPORE PTE. LTD.
Licence Holder: GLORIOUS DEXA SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: Recommended Dosage: Cytostatic therapy Adults 3 mg granisetron which should be administered either in 15 ml infusion fluid as an intravenous bolus over not less than 30 seconds or diluted in 20 to 50 ml infusion fluid and administered over five minutes. Prevention: The majority of patients have required only a single dose of granisetron to control nausea and vomiting over 24 hours. Up to two additional doses of 3 mg granisetron may be administered within a 24-hour period. There is clinical experience in patients receiving daily administration for up to five consecutive days in one course of therapy. Prophylactic administration of granisetron should be completed prior to the start of cytostatic therapy. Treatment: The same dose of granisetron should be used for treatment as prevention. Additional doses should be administered at least 10 minutes apart. Maximum daily dosage: Up to three doses of 3 mg granisetron may be administered within a 24-hour period. The maximum dose of granisetron to be administered over 24 hours should not exceed 9 mg. Concomitant use of dexamethasone The efficacy of granisetron may be enhanced by the addition of dexamethasone. Elderly No special requirements apply to elderly patients. Children Prevention: A single dose of 40 mcg/kg body weight (up to 3 mg) should be administered as an intravenous infusion, diluted in 10 to 30 ml infusion fluid and administered over five minutes. Administration should be completed prior to the start of cytostatic therapy. Treatment: The same dose of granisetron as above should be used for treatment as prevention. One additional dose of 40 mcg/kg body weight (up to 3 mg) may be administered within a 24-hour period. This additional dose should be administered at least 10 minutes apart from the initial infusion. Patients with renal or hepatic impairment No special requirements apply to those patients with renal or hepatic impairment. Preparation of infusion Granisetron solution for injection or infusions must be prepared at the time of administration and under appropriate aseptic conditions. Adults: To prepare a dose of 3 mg, 3 ml is withdrawn from the ampoule and diluted either to 15 ml with 0.9% sodium chloride (for bolus administration) or in a compatible infusion fluid to a total volume of 20 to 50 ml, in any of the following solutions: 0.9% sodium chloride, Ringer’s lactate, 5% dextrose, and 20% mannitol solution. The mixtures solutions are stable within 24 hours at temperatures below 30ºC. Children: The appropriate dose is diluted with a compatible infusion fluid (as for adults) to a total volume of 10 to 30 ml, in any of the following solutions: 0.9% sodium chloride, Ringer’s lactate, 5% dextrose, and 20% mannitol solution. The mixtures solutions are stable within 24 hours at temperatures below 30ºC. Postoperative nausea and vomiting Adults Prevention: For prevention in adults, a single dose of 1 mg of granisetron should be diluted to 5 ml and administered as a slow intravenous injection (over 30 seconds). Administration should be completed prior to induction of anesthesia. Treatment: For the treatment of established postoperative nausea and vomiting in adults, a single dose of 1 mg of granisetron should be diluted to 5 ml and administered by slow intravenous injection (over 30 seconds). Maximum dose and duration of treatment: Two doses (2 mg) in one day. Preparation of injection Adults: To prepare a dose of 1 mg, 1 ml should be withdrawn from the ampoule and diluted to 5 ml with 0.9% sodium chloride. No other diluents should be used. Children: There is no experience in the use of granisetron in the prevention and treatment of postoperative nausea and vomiting in children. Granisetron is not therefore recommended for the treatment of postoperative nausea and vomiting in this age group. Elderly patients As for adults. Renally impaired and hepatically impaired patients As for adults.
Route Of Administration: INTRAVENOUS
Indication Info: Indications: Granisetron is indicated for the prevention or treatment of nausea and vomiting induced by cytostatic therapy and for the prevention and treatment of postoperative nausea and vomiting.
Contraindications: Contraindication: Granisetron is contraindicated in patients with known hypersensitivity to granisetron or to any of its excipients.
Atc Code: A04AA02
Atc Item Name: granisetron
Pharma Manufacturer Name: GLORIOUS DEXA SINGAPORE PTE. LTD.

Active Ingredients

Granisetron hydrochloride equivalent to granisetron

1mg/ml

GRANISETRON HYDROCHLORIDE EQUIVALENT TO GRANISETRON

1 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 1, 2022

Approval ID

0f9b55109fe525ff

Type

Therapeutic

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