Granisetron Martindale Pharma 3mg/3ml Concentrate for Solution for Injection/Infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Granisetron hydrochloride

Pieejams no:

Martindale Pharmaceuticals Ltd

ATĶ kods:

A04AA; A04AA02

SNN (starptautisko nepatentēto nosaukumu):

Granisetron hydrochloride

Deva:

3mg/3ml

Zāļu forma:

Concentrate for solution for injection

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Serotonin (5HT3) antagonists; granisetron

Autorizācija statuss:

Not marketed

Autorizācija datums:

2008-09-05

Lietošanas instrukcija

MODULE 1 1.3 PRODUCT INFORMATION
APPLICANT: MARTINDALE PHARMACEUTICALS
LTD
PRODUCT: GRANISETRON MARTINDALE PHARMA
® 3MG/3ML CONCENTRATE
FOR SOLUTION FOR INJECTION/INFUSION
LEAFLET
MODULE 1 1.3 PRODUCT INFORMATION
APPLICANT: MARTINDALE PHARMACEUTICALS
LTD
PRODUCT: GRANISETRON MARTINDALE PHARMA
® 3MG/3ML CONCENTRATE
FOR SOLUTION FOR INJECTION/INFUSION
PACKAGE LEAFLET INFORMATION FOR THE PATIENT GRANISETRON MARTINDALE PHARMA
3MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Granisetron 3mg/3ml
(Concentrate for Solution for Injection/Infusion)
WHAT IS IN THIS LEAFLET
1.
What Granisetron Martindale Pharma is and what it is used for
2.
What you need to know before you are given Granisetron Martindale
Pharma
3.
How you will be given Granisetron Martindale Pharma
4.
Possible side effects
5.
How to store Granisetron Martindale Pharma
6.
Contents of the pack and other information
1. WHAT GRANISETRON MARTINDALE PHARMA IS AND WHAT IT IS USED FOR
Granisetron Martindale Pharma contains a medicine called granisetron.
This belongs
to a group of medicines called ‘5-HT
3
receptor antagonists’ or ‘anti-emetics’.
Granisetron Martindale Pharma is used to prevent or treat nausea and
vomiting
(feeling and being sick) caused by other medical treatments, such as
chemotherapy
or radiotherapy for cancer, and by surgery.
The solution for injection is for use in adults and children from 2
years old.
Granisetron Martindale Pharma will be given to you by a doctor or
nurse in a hospital
environment.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GRANISETRON MARTINDALE
PHARMA
DO NOT TAKE GRANISETRON MARTINDALE PHARMA
•
If you are allergic to granisetron or any other ingredients of this
medicine
(listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
having the
injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before taking Granisetron Martindale
Pharma if you:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR Y

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Granisetron Martindale Pharma 3mg/3ml Concentrate for Solution for
Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is granisetron.
Each 3 ml of concentrate contains 3mg granisetron (as hydrochloride)
(1 mg/ml)
Each 1 ml of concentrate contains 27 mg sodium chloride, equivalent to
10.62 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion
The solution for injection/infusion is a sterile, clear and colourless
liquid, with a pH of 4.0 – 6.0. The osmolarity of the
product is approximately 310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Granisetron Martindale Pharma 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 Martindale Pharma solution for injection is indicated for
the prevention of delayed nausea and vomiting
associated with chemotherapy and radiotherapy.
Granisetron Martindale Pharma solution for injection 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)
A dose of 1-3 mg (10-40µg/kg) of Granisetron Martindale Pharma
solution for injection should be administered either
as a slow intravenous injection or as a diluted intravenous infusion 5
minutes prior to the start of chemotherapy.
The
solution should be diluted to 5ml per mg.
TREATMENT (ACUTE NAUSEA)
A dose of 1-3 mg (10-40µg/kg) of Granisetron Martindale Pharma
solution for injection 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 5ml per mg. Further maintenance doses