Granisetron 3mg/3ml concentrate for solution for injection ampoules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Granisetron hydrochloride

Tillgänglig från:

hameln pharma Ltd

ATC-kod:

A04AA02

INN (International namn):

Granisetron hydrochloride

Dos:

1mg/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intravenous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04060000; GTIN: 4260016650583 5016386000126

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
GRANISETRON 1 MG/ML
concentrate for solution for injection or infusion
HAMELN
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side effects not
listed in this leaflet.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS
ONLY:
PREPARATION GUIDE FOR:
HAMELN
Active substance: Granisetron hydrochloride
WHAT IS IN THIS LEAFLET:
1. What Granisetron is and what it is used for
2. What
you
need
to
know
before
you
are
given
Granisetron
3. How Granisetron will be given
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and other information
1.
WHAT GRANISETRON IS AND WHAT IT IS USED
FOR
Granisetron 1 mg/ml concentrate for solution for injection
or infusion contains a medicine called granisetron. This
belongs to a group of medicines called ‘5-HT
3
receptor
antagonists’ or ‘antiemetics’.
Granisetron is used to prevent or treat nausea (feeling
sick) and vomiting (being sick) caused by other medical
treatments, such as chemotherapy or radiotherapy for
cancer, and by surgery.
The solution for injection or infusion is for use in adults,
adolescents and children from 2 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN GRANISETRON
DO NOT USE GRANISETRON
-
if you are ALLERGIC (hypersensitive) to granisetron or
any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using
Granisetron
Ch

Produktens egenskaper

OBJECT 1
GRANISETRON 1 MG/ML CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 27-Jun-2017 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Granisetron 1 mg/ml concentrate for solution for injection or infusion
2. Qualitative and quantitative composition
The active substance is granisetron hydrochloride.
1ml concentrate for solution for injection or infusion contains 1.12
mg granisetron hydrochloride
equivalent to 1 mg granisetron.
3 ml concentrate for solution for injection or infusion contains 3.36
mg granisetron hydrochloride
equivalent to 3 mg granisetron.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for injection or infusion
The solution for injection is a clear, colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Granisetron is indicated in adults for the prevention and treatment of
- acute nausea and vomiting associated with chemotherapy and
radiotherapy.
- post-operative nausea and vomiting.
Granisetron is indicated for the prevention of delayed nausea and
vomiting associated with chemotherapy
and radiotherapy.
Granisetron is indicated in children aged 2 years and above for the
prevention and treatment of acute
nausea and vomiting associated with chemotherapy.
4.2 Posology and method of administration
POSOLOGY
Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV)
Prevention (acute and delayed nausea and vomiting)
A dose of 1 – 3 mg (10 – 40 µg/kg) of Granisetron should be
administered either as a slow intravenous
injection or as a diluted intravenous infusion 5 minutes prior to the
start of chemotherapy or radiotherapy.
The solution should be diluted to 5 ml per mg.
Treatment (acute nausea and vomiting)
A dose of 1 – 3 mg (10 – 40 µg/kg) of Granisetron should be
administered either as a slow intravenous
injection or as a diluted intravenous infusion and administered over 5
minutes. The solution should be
diluted to 5 ml per mg. Further maintenance doses o