Granirex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Granisetron hydrochloride 1.12 mg/mL

Available from:

REX Medical Ltd

INN (International Name):

Granisetron hydrochloride 1.12 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Granisetron hydrochloride 1.12 mg/mL Excipient: Citric acid monohydrate Hydrochloric acid Methyl hydroxybenzoate Propyl hydroxybenzoate Sodium chloride Sodium hydroxide Water for injection

Units in package:

Vial, glass, Type I borosilicate glass 3 mL vial with rubber stopper and aluminium flip-off cap. 1 mL fill volume, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

Granisetron is indicated for the prevention of acute and delayed nausea and vomiting associated with cytostatic therapy, and for the prevention and treatment of post-operative nausea and vomiting.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I borosilicate glass 3 mL vial with rubber stopper and aluminium flip-off cap. 1 mL fill volume - 1 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze 24 hours opened stored at or below 25°C protect from light. Do not freeze - Vial, glass, Type I borosilicate glass 6 mL vial with rubber stopper and aluminium flip-off cap. 4 mL fill volume - 4 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze 24 hours opened stored at or below 25°C protect from light. Do not freeze

Authorization date:

2006-06-29

Summary of Product characteristics

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
GRANIREX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Granisetron hydrochloride injection
3 PHARMACEUTICAL FORM
GRANIREX is administered as the hydrochloride salt, granisetron
hydrochloride.
GRANIREX 0.1 mg/ml injection solution single-use vials contain a clear
colourless solution
equivalent to 0.1 mg of granisetron per 1 mL. The vial has a fill
volume of 1 mL.
GRANIREX 1 mg/ml injection solution vials contain a clear colourless
solution equivalent to 1
mg of granisetron per 1 mL. The single-use vials have a 1 mL fill
volume and the multi-use vials
have a 4 mL fill volume.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ADULTS:
Granisetron injection is indicated for use in adults for:
1. The prevention and treatment of nausea and vomiting induced by
cytotoxic chemotherapy;
2. The prevention of nausea and vomiting induced by radiotherapy.
3. The prevention and treatment of post-operative nausea and vomiting.
PAEDIATRIC:
Granisetron injection is indicated for the prevention of nausea and
vomiting induced
by cytotoxic chemotherapy.
4.2
Dose and method of administration
_Standard Dosage by indication for adult and paediatric patients are
shown below. _
Indication: Chemotherapy Induced Nausea and Vomiting (CINV)
Adults
Prevention of nausea and vomiting in adults
A single dose of 3 mg of Granisetron injection should be administered
as an intravenous
infusion, diluted in 20 to 50 mL infusion fluid and administered over
5 minutes prior to the start
of chemotherapy. The infusion should be commenced within 30 minutes
before the start of
chemotherapy.
Prophylactic administration of Granisetron injection should be
completed prior to the start of
chemotherapy.
In clinical trials, the majority of patients have required only a
single dose of granisetron to
control nausea and vomiting over 24 hours.
Treatment of established nausea and vomiting in adults
A single dose of 1 mg of Granisetron injection should be administered
as a 5 minute infusion.
Further treatment doses of Granisetron injec