KYTRIL FOR INFUSION 3 MG/3ML

CENEXI SAS (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Jun 22, 1992
Approval ID: ed4abd7b31876762
Company: CENEXI SAS (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: ed4abd7b31876762
Drug Name: KYTRIL FOR INFUSION 3 MG/3ML
Product Name: KYTRIL FOR INFUSION 3 MG/3ML
Approval Number: SIN07089P
Approval Date: 1992-06-22
Registrant: DCH AURIGA SINGAPORE
Licence Holder: DCH AURIGA SINGAPORE
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: Dosage and administration Cytostatic therapy Intravenous Kytril ampoules are for intravenous administration only. Adults 3mg Kytril which should be administered either in 15ml 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: in clinical trials, the majority of patients have required only a single dose of Kytril to control nausea and vomiting over 24 hours. Up to two additional doses of 3mg Kytril 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 Kytril should be completed prior to the start of cytostatic therapy. Treatment: the same dose of Kytril 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 3mg Kytril may be administered within a 24-hour period. The maximum dose of Kytril to be administered over 24 hours should not exceed 9mg. Concomitant use of dexamethasone The efficacy of Kytril may be enhanced by the addition of dexamethasone. Elderly No special requirements apply to elderly patients. Children Prevention: a single dose of 40micrograms/kg body weight (up to 3mg) 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 Kytril as above should be used for treatment as prevention. One additional dose of 40micrograms/kg body weight (up to 3mg) 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. Administration Adults To prepare a dose of 3mg, 3ml is withdrawn from the ampoule and diluted either to 15ml with 0.9% w/v Sodium Chloride Injection BP [British Pharmacopeia] (for bolus administration) or in infusion fluid to a total volume of 20 to 50 ml in any of the following solutions: 0.9% w/v Sodium Chloride Injection BP; 0.18% w/v Sodium Chloride and 4% w/v Glucose Injection BP; 5% w/v Glucose Injection BP; Hartmann's Solution for Injection BP; Sodium Lactate Injection BP; or 10% Mannitol Injection BP (for infusion). No other diluents should be used. Children To prepare the dose of 40micrograms/kg the appropriate volume (up to 1ml from the 1mg ampoule or up to 3ml from the 3mg ampoule) is withdrawn and diluted with infusion fluid (as for adults) to a total volume of 10 to 30ml. Oral The tablet is only indicated for use in the prevention of nausea and vomiting induced by cytostatic therapy. Adults (Tablets) Prevention: 1mg twice a day or 2mg once a day during cytostatic therapy. The first dose should be administered within one hour before the start of cytostatic therapy. Kytril is also available as ampoules for intravenous administration. The maximum dose of Kytril administered over 24 hours should not exceed 9mg. Treatment: There is insufficient information to recommend the oral administration of Kytril in the treatment of nausea and vomiting induced by cytostatic therapy. Concomitant use of dexamethasone The efficacy of Kytril may be enhanced by the addition of dexamethasone. Elderly No special requirements apply to elderly patients. Children There is insufficient information to recommend the oral administration of Kytril in the prevention and treatment of nausea and vomiting induced by cytostatic patients. Patients with renal or hepatic impairment No special requirements apply to those patients with renal or hepatic impairment. Post-operative nausea and vomiting Intravenous Adults Prevention: for prevention in adults, a single dose of 1mg of Kytril should be diluted to 5ml 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 post-operative nausea and vomiting in adults, a single dose of 1mg of Kytril should be diluted to 5ml and administered by slow intravenous injection (over 30 seconds). Maximum dose and duration of treatment: two doses (2mg) in one day. Administration Adults To prepare a dose of 1mg, 1ml should be withdrawn from the ampoule and diluted to 5ml with 0.9% w/v Sodium Chloride Injection BP. No other diluents should be used. Children There is no experience in the use of Kytril in the prevention and treatment of post-operative nausea and vomiting in children. Kytril is not therefore recommended for the treatment of post-operative 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 and usage Tablets Kytril is indicated for the prevention of nausea and vomiting induced by cytostatic therapy. Ampoules Kytril is indicated for the prevention or treatment of nausea and vomiting induced by cytostatic therapy and for the prevention and treatment of post-operative nausea and vomiting.
Contraindications: Contraindications Kytril 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: DKSH SINGAPORE PTE. LTD.

Active Ingredients

GRANISETRON EQV GRANISETRON HCl

3 mg/3 ml

GRANISETRON EQV GRANISETRON HCl

3 mg/3 ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 22, 1992

Approval ID

ed4abd7b31876762

Type

Therapeutic

Back to HSA Approvals