Gramet Injeksi

GRAMET^®
Solution injection

COMPOSITION
Each ml solution injection contain Granisetron HCl equivalent to 1 mg of Granisetron base.

INDICATIONS
Granisetron 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 ADMINISTRATION
Granisetron ampoules are for intravenous infusion only.
Standard dosage:

• Chemotherapy Induced Nausea and Vomiting (CINV):
  • Adults
    • Preventions: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered either as a slow IV-injection (over 30 seconds), or as an IV-infusion diluted in 20-50 ml infusion fluid and administered over 5 minutes, prior to the start of chemotherapy. Treatment: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered either as a slow IV-injection (over 30 seconds) or as an IV-infusion diluted in 20-50 ml infusion fluid and administered over 5 minutes, prior to the start of chemotherapy. 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 9 mg.
  • Pediatrics
    • A dose of 10-40 mcg body weight (up to 3 mg) should be administered as an IV-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-hour period if required. This additional dose should not be administered until at least 10 minutes after the initial infusion.
• Radiotherapy Induced Nausea and Vomiting (RINV):
  • Adults
    • Prevention: A dose of 1-3 mg (10-40 mcg/kg) of granisetron should be administered either as a slow IV-injection (over 30 seconds), or as an IV-infusion diluted in 20-50 ml infusion fluid and administered over 5 minutes, prior to the start of radiotherapy.
  • Pediatrics
    • There is insufficient information to recommend use of granisetron in the prevention and treatment of Radiotherapy Induced Nausea and Vomiting (RINV) in children.
• Post-operative Nausea and Vomiting (PONV):
  • Adults
    • Prevention: A dose of 1 mg (10 mcg/kg) of granisetron should be administered either as a slow IV-injection (over 30 seconds), prior to induction of anaesthesia.
    • Treatment: A dose of 1 mg (10 mcg/kg) of granisetron should be administered as a slow IV-injection (over 30 seconds). The maximum dose for patients undergoing anesthesia for surgery is a total dose of 3 mg of granisetron IV in one day.
  • Pediatrics
    • There is insufficient information to recommend use of granisetron in the prevention and treatment of Post Operative Nausea and Vomiting (PONV) in children.

Maximum dose and duration of treatment:
Two doses (2 mg) granisetron in one day.

Special dosage instructions:
No dosage adjustments required in geriatric patients and patients with hepatic/ renal impairment.

To prepare the dose of 3 mg, 3 ml is withdrawn from the ampoule and diluted with 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; sodium lactate injection BP or 10% mannitol injection BP.
No other diluents should be used.

CONTRAINDICATIONS
Hypersensitivity to granisetron or related substances.

PRECAUTIONS
Granisetron may reduce lower bowel motility, patients with signs of sub acute intestinal obstruction should be monitored following administration of granisetron.
There has be en no evidence from human studies that granisetron has any adverse effects on alertness.

Drug Interactions
No evidence of any interaction has been indicated between granisetron and cimetidine or lorazepam. No evidence of drug interactions has been observed.

Use in Pregnancy and Lactation
Whilst animal studies have shown no teratogenic effects, there is no experience of granisetron in human pregnancy. Therefore granisetron should not be administered to women who are pregnant unless there are compelling clinical reasons. There are no data on the excretion of granisetron in breast milk. Breast feeding should therefore be discontinued during therapy.

ADVERSE REACTIONS
Granisetron has been generally well tolerated in human studies. No extrapyramidal effects or other serious adverse reactions definitely related to the administration of granisetron have been observed. Cases of headache and constipation have been the most frequently noted adverse events, but the majority have been mild or moderate in nature and tolerated by patients, have been reported. Transient increases in mean levels of hepatic transaminases, remaining within the normal range, have be en seen.

OVERDOSAGE
There is no specific antidote for granisetron. In case of overdosage, symptomatic treatment should be given.

PHARMACEUTICAL PRECAUTIONS
Ampoules removed from the pack should be protected from direct sunlight. Do not freeze.
Ideally, intravenous infusions of granisetron should be prepared at the time of administration. After dilution (see Dosage and administration) the shelf-life is 24 hours when stored at ambient temperature in normal indoor illumination protected from direct sunlight. It must not be used after 24 hours. If to be stored after preparation, granisetron infusion must be prepared under appropriate aseptic conditions.
As a general precaution, granisetron should not be mixed in solution with other drugs.

Further Information
Granisetron is widely distributed with plasma protein binding of approximately 65%. It is rapidly and extensively metabolized mainly by N-demethylation and aromatic ring oxidation followed by conjugation; excretion is both urinary and faecal.

STORAGE
Do not store above 30°C. Protect from light.

PACKAGE
Box, 5 ampoules @ 1 ml
Box, 5 ampoules @ 3 ml
Reg. No. DKLl121634743A1

On Medical Prescription Only 
HARUS DENGAN RESEP DOKTER

Manufactured by :
PHAROS
Jakarta - Indonesia

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