- Approval Id
- 8216743d7aba4026
- Drug Name
- GRANISETRON FRESENIUS INJECTION 1MG/ML
- Product Name
- GRANISETRON FRESENIUS INJECTION 1MG/ML
- Approval Number
- SIN16141P
- Approval Date
- 2021-03-29
- Registrant
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Licence Holder
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **DOSAGE AND ADMINISTERING PROCEDURE**
**Cytostatic therapy**
**Intravenous**
Granisetron ampoules are for intravenous administration only.
**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:** in clinical trials, 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 micrograms/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 micrograms/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.
**Administration**
**Adults**
To prepare a dose of 3 mg, 3 mL is withdrawn from the ampoule and diluted either to 15 mL with NaCl 0.9% infusion solution or in infusion fluid to a total volume of 20 to 50 mL in any of the following solutions: NaCl 0.9% infusion solution, Dextrose 5% infusion solution and Ringer Lactate infusion solution. No other diluents should be used.
**Children**
To prepare the dose of 40 micrograms/kg the appropriate volume (up to 1 mL from the 1mg ampoule or up to 3 mL from the 3 mg ampoule) is withdrawn and diluted with infusion fluid (as for adults) to a total volume of 10 to 30 mL.
**Post-operative nausea and vomiting**
**Intravenous**
**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 post-operative nausea and vomiting in adults, a single dose of 1 mg of Granisetron should be diluted to 5ml and administered by slow intravenous injection (over 30 seconds).
**Maximum dose and duration of treatment:** two doses (2 mg) in one day.
**Administration**
**Adults**
To prepare a dose of 1 mg, 1 mL should be withdrawn from the ampoule and diluted to 5ml with NaCl 0.9% infusion solution. No other diluents should be used.
**Children**
There is no experience in the use of Granisetron in the prevention and treatment of post-operative nausea and vomiting in children. Granisetron 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 DRIP, INTRAVENOUS BOLUS
- 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 post-operative nausea and vomiting.
- Contraindications
- **CONTRAINDICATION**
Known hypersensitivity to Granisetron or any of the excipients.
- Atc Code
- A04AA02
- Atc Item Name
- granisetron
- Pharma Manufacturer Name
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/15bc26a40571352c/fresenius-kabi-singapore-pte-ltd
