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ONDANSETRON KABI 2 MG/ML SOLUTION FOR INJECTION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Anexo 6.00 do PT.G.087

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- sensation of warmth or flushing
- irritation and redness at the site of
injection
Uncommon
- low blood pressure, which can make you
feel faint or dizzy
- slow or uneven heart beat
- chest pain fits
- unusual body movements or shaking
- hiccups
- interference with liver function tests
Rare
- feeling dizzy or light headed
- blurred vision
- hypersensitivity reactions
- disturbance in heart rhythm (sometimes
causing a sudden loss of consciousness)
Very rare
- temporary blindness (most resolved within
20 minutes)
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet.
You can also report side effects directly
For UK: via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For Ireland via:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website:www.hpra.ie;
E-mail: medsafety@hpra.ie
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. HOW TO STORE ONDANSE­TRON KABI
Keep this medicine out of the sight and
reach of children.
Ondansetron Kabi must not be administered
after the expiry date, which is stated on the
ampoule label and carton. The expiry date
refers to the last day of that month.
Keep the ampoules in the outer carton, in
order to protect from light.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ondansetron Kabi contains
The active substance is ondansetron.
Each ampoule with 2 ml contains 4 mg
ondansetron.
Each ampou­
le with 4 ml contains 8 mg
ondansetron.

ondansetron hydrochloride dihydrate.
The other ingredients are sodium chloride,
sodium citrate dihydrate, citric acid
monohydrate and water for injections.
What Ondansetron Kabi looks like and
contents of the pack
Ondansetron Kabi is a clear and colourless
solution in colourless glass ampoules
containing 2 ml or 4 ml of solution for
injection.
Pack sizes: 1, 5 and 10 ampoules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way
Manor Park, Runcorn
Cheshire WA7 1NT
United Kingdom
Manufacturer:
Labesfal - Laboratórios Almiro S.A.
Lagedo, 3465-157 Santiago de Besteiros,
Portugal.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
BE: Ondansetron Fresenius Kabi 2 mg/ml,
solution injectable/ Injektionslösung/
oplossing voor injectie
CZ: Ondansetron Kabi 2 mg/ml, injekční
roztok
DK: Ondansetron
Fresenius
Kabi
injektionsvæske, opløsning
EL: Ondansetron Kabi 2 mg/ml ενέσιμο
διάλυμα
ES: Ondansetrón Fresenius Kabi 2 mg/ml,
inyectable
FI: Ondansetron Fresenius Kabi 2 mg/ml,
injektioneste, liuos
HU: Ondansetron Kabi 2 mg/ml injekció
IE: Ondansetron Kabi 2 mg/ml, solution
for injection
IT: Ondansetron Kabi 2 mg/ml, soluzione
iniettabile
NL: Ondansetron Kabi 2 mg/ml, oplossing
voor injectie
NO: Ondansetron Fresenius Kabi 2 mg/ml,
injeksjonsvæske, oppløsning
PL: Ondansetron Kabi 2 mg/ml roztwór
do wstrzykiwa n´
SE: Ondansetron Fresenius Kabi 2 mg/ml,
injektionsvätska, lösning
SK: Ondansetron Kabi 2 mg/ml injekčný
roztok
UK: Ondansetron Kabi 2 mg/ml, solution
for injection
This leaflet was last revised in February 2016
----------------------------

Each millilitre contains 2 mg ondansetron as

The following information is intended for
medical or healthcare professio­nals only.
A single dose greater than 16mg must not
be given due to the risk of dose dependent
increase in QT prolongation (see sections
4.2, 4.4, 4.8 and 5.1 of the SmPC).
Use only clear and colourless solutions.
For single use only. Any unused solution and
the ampoule should be adequately disposed
of, in accordance with local requirements.
To be used immediately after the ampoule
is opened.
Ondansetron Kabi may be diluted with
solutions for infusion containing:
Sodium chloride 9 mg/ml (0.9 % w/v)
solution
Glucose 50 mg/ml (5 % w/v) solution
Mannitol 100 mg/ml (10 % w/v) solution
Ringer’s lactate solution
Chemical and physical in-use stability has
been demonstrated for 48 hours at 25°C
with these solutions. Unless compatibility
is proven, the solution for infusion should
always be administered separately.
The diluted solutions should be stored
protected from light.

XXXXXX/XX
V005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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