Ondansetron Kabi 2 mg/ml solution for injection

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ondansetron

Disponible desde:

Fresenius Kabi Deutschland GmbH

Código ATC:

A04AA; A04AA01

Designación común internacional (DCI):

Ondansetron

Dosis:

2 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

Área terapéutica:

Serotonin (5HT3) antagonists; ondansetron

Estado de Autorización:

Marketed

Fecha de autorización:

2007-07-06

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT_ _
ONDANSETRON KABI 2 MG/ML SOLUTION FOR INJECTION_ _
ondansetron
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.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Ondansetron Kabi is and what it is used for
2.
What you need to know before you use Ondansetron Kabi
3.
How to use Ondansetron Kabi
4.
Possible side effects
5.
How to store Ondansetron Kabi
6.
Contents of the pack and other information
1.
WHAT ONDANSETRONKABI IS AND WHAT IT IS USED FOR
Ondansetron Kabi belongs to a group of medicines called anti-emetics,
drugs against feeling
sick
or
being
sick.
Some
medical
treatment
with
medicines
for
treatment
of
cancer
(chemotherapy) or radiotherapy can make you feel sick (nausea) or be
sick (vomiting). Also
after surgical treatment you can feel sick (nausea) or be sick
(vomiting). Ondansetron Kabi may
help to prevent or to stop these effects.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE ONDANSETRON KABI
DO NOT USE ONDANSETRON KABI _ _
-
if you are hypersensitive to ondansetron or to other selective 5HT
3
receptor antagonists
(e.g.granisetron, dolastron) or to any of the excipients (listed in
section 6).
-
if you are treated with apomorphine (drug to treat Parkinson’s
disease)
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Ondansetron Kabi
-
if you have reacted hypersensitive to other medicines against feeling
sick or being sick, such
as granisetron or palonosetron.
-
if you have a blockage in your gut or suffer from severe constipation.
Ondansetron can
impede the mobility of the lower gut.
-
if you have any hepatic impairment.
2
-
if you have undergone surgery to remove the palatine tonsils situated
a

Ficha técnica

Health Products Regulatory Authority
18 April 2023
CRN00CZN8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondansetron Kabi 2 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Ondansetron hydrochloride dihydrate equivalent to 2 mg ondansetron.
Each ampoule with 2 ml contains 4 mg ondansetron.
Each ampoule with 4 ml contains 8 mg ondansetron.
1 ml solution for injection contains 3.34 mg of sodium as sodium
citrate dihydrate and sodium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults:_
Ondansetron Kabi is indicated for management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy
Ondansetron Kabi is also indicated for the prevention and treatment of
post-operative nausea and vomiting (PONV).
_Paediatric Population: _
Ondansetron Kabi is indicated for the management of
chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6
months, and for prevention and treatment of PONV in children aged ≥1
month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous injection or for intravenous infusion after dilution.
For instructions on dilution of the product before administration, see
section 6.6.
Chemotherapy and radiotherapy induced nausea and vomiting (CINV and
RINV)
_Adults_
The emetogenic potential of cancer treatment varies according to the
doses and combinations of chemotherapy and
radiotherapy regimens used. The route of administration and dose of
Ondansetron Kabi should be flexible in the range of 8-32
mg a day and selected as shown below.
Emetogenic chemotherapy and radiotherapy
For patients receiving emetogenic chemotherapy or radiotherapy
ondansetron can be given either by intravenous ororal
administration.
The recommended intravenous dose of ondansetron is 8 mg administered
as a slow intravenous injection in not less than 30
seconds imme