Ondansetron Kabi 2 mg/ml solution for injection (2ml vial)

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Disponible desde:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Código ATC:

A04AA01

Designación común internacional (DCI):

ONDANSETRON 4 mg

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

ONDANSETRON 4 mg

tipo de receta:

POM

Área terapéutica:

ANTIEMETICS AND ANTINAUSEANTS

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Authorised

Fecha de autorización:

2022-02-28

Información para el usuario

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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.
-
if you have undergone surgery to remove the palatine tonsils si

Ficha técnica

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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.
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
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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 or oral administration.
The recommended intravenous dose of ondansetron is 8 mg administered
as a slow
intravenous injection in not less than 30 seconds immediately before
treatment.
Oral or rectal treatment is recommended to protect against delayed or
prolonged emesis after
the first 24 hours.
For oral