Ondansetron Kabi 0.16 mg/ml solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ondansetron hydrochloride dihydrate

Verfügbar ab:

Fresenius Kabi Deutschland GmbH

ATC-Code:

A04AA01

INN (Internationale Bezeichnung):

Ondansetron hydrochloride dihydrate

Darreichungsform:

Solution for infusion

Therapiebereich:

ondansetron

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2022-06-10

Gebrauchsinformation

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT_ _
ONDANSETRON KABI 0.08 MG/ML SOLUTION FOR INFUSION
ONDANSETRON KABI 0.16 MG/ML SOLUTION FOR INFUSION_ _
ondansetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 are given Ondansetron Kabi
3.
How Ondansetron Kabi is given
4.
Possible side effects
5.
How to store Ondansetron Kabi
6.
Contents of the pack and other information
1.
WHAT ONDANSETRON KABI IS AND WHAT IT IS USED FOR
Ondansetron Kabi belongs to a group of medicines called anti-emetics,
medicines 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 YOU NEED TO KNOW BEFORE YOU ARE GIVEN ONDANSETRON KABI
DO NOT USE ONDANSETRON KABI _ _
-
if you are allergic to ondansetron or other selective 5HT
3
receptor antagonists (e.g.
granisetron, dolastron) or any of the other ingredients of this
medicine (listed in section 6).
-
if you are treated with apomorphine (used to treat Parkinson’s
disease)
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Ondansetron
Kabi.
-
if you have had allergy 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.
This medicine can
block the mobility of the lower gut.
-
if you have any liver problems.
-
if y

Fachinformation

Health Products Regulatory Authority
10 January 2024
CRN00DZZ7
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondansetron Kabi 0.16 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ondansetron Kabi 0.16 mg/ml solution for infusion
1 ml solution for infusion contains 0.16 mg ondansetron (as
hydrochloride dihydrate).
Each bottle with 50 ml contains 8 mg ondansetron.
Excipient with known effect:
Each ml of solution contains 3.57 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless and practically particle-free solution.
pH: 3.3 – 4.0
Osmolality: 270 - 330 mOsmol/kg
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 infusion.
Posology
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 or oral
administration.
The recommended dose of ondansetron is 8 mg administered as an
intravenous infusion over 15 minutes immediately before
treatment.
Oral or rectal treatment is recommended to protect against delayed or
prolonged emesis afte