GRANISETRON KABI granisetron (as hydrochloride) 1mg/1mL concentrated injection ampoule

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

granisetron hydrochloride, Quantity: 1.12 mg/mL (Equivalent: granisetron, Qty 1 mg/mL)

Disponível em:

Fresenius Kabi Australia Pty Ltd

DCI (Denominação Comum Internacional):

granisetron hydrochloride

Forma farmacêutica:

Injection, concentrated

Composição:

Excipient Ingredients: hydrochloric acid; sodium chloride; sodium hydroxide; citric acid monohydrate; water for injections

Via de administração:

Intravenous Infusion

Unidades em pacote:

1, 10, 5

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy in adults and children. Prevention of nausea and vomiting induced by radiotherapy in adults only. Prevention and treatment of post-operative nausea and vomiting in adults only.

Resumo do produto:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2010-08-12

Folheto informativo - Bula

CMI for Granisetron Kabi
Injection
March 2018
Filename: GraCMI270218 clean
Page 1 of 3
Change: indication extension
GRANISETRON KABI
INJECTION
Granisetron (as hydrochloride)
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
hydrochloride.
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,
radiotherapy or surgery.
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.
•
YO

Características técnicas

Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
GRANISETRON KABI (GRANISETRON HYDROCHLORIDE)
1 NAME OF THE MEDICINE
Granisetron hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Granisetron hydrochloride is a white to off-white crystalline powder
which is
freely soluble in water and sodium chloride 0.9% at 20°C.
Granisetron Kabi Concentrated Injection contains granisetron
hydrochloride
equivalent to granisetron free base 1 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Concentrated Injection
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Prevention and treatment of nausea and vomiting induced by cytotoxic
chemotherapy in adults and children.

Prevention of nausea and vomiting induced by radiotherapy in adults
only.

Prevention and treatment of post-operative nausea and vomiting in
adults
only.
4.2 DOSE AND METHOD OF ADMINISTRATION
Granisetron Kabi is for intravenous administration only.
Chemotherapy induced nausea and vomiting
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 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 treatment doses of Granisetron Kabi may be administered if
required
at least 10 minutes apart. The maximum dose of Granisetron Kabi is 9
mg/24
hours.
Page 2 of 13
In trials, patients have received a total dose of 160 µg/kg of
intravenous
granisetron in one day. There is also clinical experience