Granisetron Kabi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Granisetron hydrochloride 1.12 mg/mL (equivalent to granisetron 1 mg/mL)

Dosage:

1 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL Excipient: Citric acid monohydrate Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

Adults: Granisetron is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy. The prevention of nausea and vomiting induced by radiotherapy. The prevention and treatment of postoperative nausea and vomiting. Children: Granisetron is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I, clear, 3 mL, in outer cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type I, clear, 1 mL, in outer cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type I, clear, 3 mL, in outer cardboard carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type I, clear, 1 mL, in outer cardboard carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type I, clear, 3 mL, in outer cardboard carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type I, clear, 1 mL, in outer cardboard carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2014-05-15

Patient Information leaflet

CMI for Granisetron Kabi
Injection
March, 2019
GRANISETRON KABI
INJECTION
Granisetron
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Granisetron Kabi.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking Granisetron
Kabi
against
the
benefits
they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT GRANISETRON KABI
IS USED FOR
This medicine contains the active
ingredient granisetron.
Granisetron
Kabi
belongs
to
a
group
of
medicines
called
anti-
emetics.
Granisetron Kabi is given to stop
you
feeling
sick
(nauseous)
or
being
sick
(vomiting).
It
is
especially useful when you need to
have medical treatment that may
cause you to feel or be sick, for
example,
chemotherapy
or
radiotherapy.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor’s
prescription.
BEFORE
YOU
ARE
GIVEN
GRANISETRON KABI
_WHEN YOU MUST NOT BE GIVEN IT_
You must not be given Granisetron
Kabi if you have an allergy to:
•
any
medicine
containing
granisetron
•
any of the ingredients listed
at the end of this leaflet.
Some
of
the
symptoms
of
an
allergic
reaction
may
include
shortness of breath, wheezing or
breathing difficulty; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
If you are not sure whether you
should be given this medicine, talk
to your doctor.
_BEFORE YOU ARE GIVEN IT_
Tell your doctor if
•
You have allergies to any
other
medicines,
foods,
preservatives or dyes.
•
YOU HAVE HAD AN ALLERGIC
REACTION
WITH
OTHER
MEDICINES
USED
TO
PREVENT
OR
TREAT
NAUSEA
AND
VOMITING,
SUCH
AS
ONDANSETRO

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
GRANISETRON KABI, granisetron hydrochloride concentrated Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains granisetron hydrochloride equivalent to 1 mg
granisetron.
3 ml contains granisetron hydrochloride equivalent to 3 mg
granisetron.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granisetron is administered as the hydrochloride salt, granisetron
hydrochloride.
Granisetron
Kabi
Concentrated
Injection
solution
contains
a
clear
colourless
solution equivalent to 1 mg of granisetron per 1 mL.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Granisetron injection is indicated for use in adults for:
The prevention and treatment of nausea and vomiting induced by
cytotoxic
chemotherapy;
The prevention of nausea and vomiting induced by radiotherapy.
The prevention and treatment of post-operative nausea and vomiting.
PEDIATRIC:
Granisetron injection is indicated for the prevention of nausea and
vomiting
induced by cytotoxic Chemotherapy
.
4.2
DOSE AND METHOD OF ADMINISTRATION
_CHEMOTHERAPY INDUCED NAUSEA AND VOMITING_
_Intravenous Administration_
Adults: For prevention of nausea and vomiting in adults, a single dose
of 3 mg of
Granisetron Kabi 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 Kabi should be completed
prior to the
start of chemotherapy.
In clinical trials, the majority of patients have required only a
single dose of
granisetron injection to control nausea and vomiting over 24 hours.
For treatment of established nausea and vomiting in adults, a single
dose of 1 mg
of Granisetron Kabi should be administered as a 5 minute infusion.
Further
Page 1 of 12
treatment doses of Granisetron Kabi may be administered if required at
least 10
minutes apart. The maximum dose of Granisetron Kabi is 9 mg