Granirex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Granisetron hydrochloride 1.12mg equivalent to 1.0 mg granisetron base

Available from:

REX Medical Ltd

INN (International Name):

Granisetron hydrochloride 1.12 mg (equiv. 1.0 mg granisetron base)

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Granisetron hydrochloride 1.12mg equivalent to 1.0 mg granisetron base Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry white 04F58804 Purified water   Sodium starch glycolate

Units in package:

Blister pack, PVC film/Al foil, 10 tablets

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

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC film/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC film/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC film/Al foil - 50 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-06-29

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
NAME OF MEDICINE
GRANIREX
Granisetron hydrochloride tablets
PRESENTATION
GRANIREX 1 mg tablets are white, barrel-shaped, biconvex and
film-coated. They
are debossed with ‘G1’ on one side and ‘BMM’ on the other
side. Each tablet
contains 1 mg of granisetron (as hydrochloride salt).
INDICATIONS
GRANIREX tablets are indicated in adults for the prevention of acute
and delayed
nausea and vomiting associated with cytostatic therapy.
DOSAGE AND ADMINISTRATION
GRANIREX should be administered at a dose of 1 mg twice daily for up
to seven
days
following
cytostatic
therapy.
The
first
dose
of
GRANIREX
should
be
administered no more than 1 hour before the start of therapy.
DOSAGE ADJUSTMENT IN SPECIAL POPULATIONS
_Renal impairment:_
There is no evidence that changes in GRANIREX dosage are required in
patients
with renal impairment.
_ _
_Hepatic impairment:_
There is no evidence that changes in GRANIREX dosage are required in
patients
with hepatic impairment.
_ _
_Elderly:_
There is no evidence that changes in GRANIREX dosage are required in
elderly
patients.
_ _
_Children:_
There are no data to support the use of GRANIREX in children.
CONTRAINDICATIONS
Hypersensitivity
to
granisetron
or
any
component
of
the
GRANIREX
tablet
preparation (see Excipients).
WARNINGS AND PRECAUTIONS
Granisetron increases large bowel transit time; therefore, patients
with subacute
intestinal obstruction should be monitored following administration of
GRANIREX
tablets.
Patients with hypersensitivity reactions to other selective 5HT3
receptor antagonists
have also reported reactions to granisetron.
As with other 5HT3 receptor antagonists, granisetron has been reported
to produce
changes in ECG readings, including prolonging the QT interval. This
may be clinically
significant in patients with pre-existing arrhythmias or cardiac
conduction disorders.
GRANIREX should be administered with caution to patients who have
electrolyte
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abnormalities, cardiac co-morbidities or taking other medicinal
p