Graniz

Graniz Injection is a prescription medicine used to treat the symptoms of nausea and vomiting caused by chemotherapy, radiation or postoperative conditions.

Graniz Injection may be used alone or with other medications.

Graniz Injection belongs to a class of drugs called Antiemetics, Selective 5-HT3 Antagonist.

Chemically Granisetron Hydrochloride is

1-Methyl-N-[(3-endo)-9-methyl-9-aza bicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride.

Granisetron injection is indicated for the prevention or treatment of nausea and vomiting with the treatment of cancer by radiotherapy and chemotherapy and for the prevention of nausea and vomiting.

Usage

As directed by the physician.

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors, including:

• 5-HT1

• 5-HT1A

• 5-HT1B/C

• 5-HT2

and for

• Alpha1-adrenoreceptors

• Alpha2-adrenoreceptors

• Beta-adrenoreceptors

• Dopamine-D2 receptors

• Histamine-H1 receptors

• Benzodiazepine receptors

• Picrotoxin receptors

• Opioid receptors

Animal pharmacological studies have shown that in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and is effective in alleviating the retching and vomiting evoked by cytostatic treatment.

• Read the label carefully before use.

• Store below 30°C.

• Protect from light.

• Do not freeze.

• Keep out of the reach of children.

Cytostatic Therapy

The recommended dosage for Granisetron injection is 40 ug/kg administration intravenously within 30 minutes before initiation of chemotherapy.

Injection may be administered intravenously either

• Undiluted over 30 seconds

or

• Diluted over 5 minutes

One additional dose of 40 ug/kg body weight (up to 3 mg) may be administered within a 24-hour period if required.

This additional dose should be administered over five minutes.

The administration should be completed prior to the start of cytostatic therapy.

Renally Impaired

No special requirements apply.

Hepatically Impaired

No special requirements apply.

Post Operative Nausea and Vomiting

Adults

For prevention in adults, a single dose of 1 mg of Granisetron injection should be diluted to 5 ml and administered as a slow intravenous injection (over 30 seconds).

Administration should be completed prior to induction of anaesthesia.

For the treatment of established postoperative nausea and vomiting in adults, a single dose of 1 mg of Granisetron injection should be diluted to 5 ml and administered by slow intravenous injection (over 30 seconds).

Children

There is no experience in the use of Granisetron injection in the prevention and treatment of postoperative nausea and vomiting in children under 12 years of age.

Granisetron injection is therefore not recommended for the treatment of postoperative nausea and vomiting in this age group.

Elderly

As for adults.

Renally Impaired

As for adults.

Hepatically Impaired

As for adults.

Instructions For Use & Handling

As a general precaution, GRANIZ injection should not be mixed in solution with other drugs.

Prophylactic administration of Granisetron injection should be completed prior to the start of cytostatic therapy or induction of anesthesia.

Preparation Of The Infusion

Children

To prepare the dose of 40 ug/kg the appropriate volume is withdrawn and diluted with infusion fluid to a total volume of 10 to 30 ml.

Any one of the following solutions may be used:

• 0.9% w/v Sodium Chloride Injection

• 0.18% w/v Sodium Chloride Injection and 4% w/v Glucose Injection

• 5% w/v Glucose Injection

• Hartmann’s Solution for Injection

Adults

To prepare a dose of 1 mg, 1 ml should be withdrawn from the vial and diluted to 5 ml with 0.9% w/v Sodium Chloride Injection.

No other diluents should be used.

Ideally, intravenous infusion of Granisetron injection should be prepared at the time of administration.

After dilution, or when the container is opened for the first time, 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 infusions must be prepared under aseptic conditions.