Ondansetron 2 mg/ml solution for injection/infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ondansetron

Mevcut itibaren:

AS Kalceks

ATC kodu:

A04AA01

INN (International Adı):

Ondansetron

Doz:

2 milligram(s)/millilitre

Farmasötik formu:

Solution for injection/infusion

Terapötik alanı:

ondansetron

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2021-10-08

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION/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.
‒
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
‒
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ondansetron is and what it is used for
2.
What you need to know before you are given Ondansetron
3.
How Ondansetron is given
4.
Possible side effects
5.
How to store Ondansetron
6.
Contents of the pack and other information
1.
WHAT ONDANSETRON IS AND WHAT IT IS USED FOR
Ondansetron contains a medicine called ondansetron. This belongs to a
group of medicines called
antiemetics that relieve nausea and vomiting.
Adults
Ondansetron is used for the management of nausea and vomiting caused
by chemotherapy and
radiotherapy, and for the prevention and treatment of nausea and
vomiting after surgery.
Children and adolescents
Ondansetron is used for the management of nausea and vomiting caused
by chemotherapy in children
over 6 months of age and adolescents.
Ondansetron is used for the prevention and treatment of nausea and
vomiting after surgery in children
over 1 month of age and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ONDANSETRON
YOU SHOULD NOT BE GIVEN ONDANSETRON IF:
‒
you are allergic to ondansetron or any of the other ingredients of
this medicine (listed in
section 6);
‒
you are using apomorphine (to treat Parkinson’s disease).
You will not be given Ondansetron if any of the above apply to you. If
you are not sure, talk to your
doctor or nurse before you are given this medicine.
WARNINGS AND PRECAUTIONS
Ta

Ürün özellikleri

Health Products Regulatory Authority
09 December 2022
CRN00D4P6
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondansetron 2 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains ondansetron hydrochloride dihydrate
equivalent to 2 mg ondansetron.
Each ampoule with 2 ml solution contains ondansetron hydrochloride
dihydrate equivalent to 4 mg ondansetron.
Each ampoule with 4 ml solution contains ondansetron hydrochloride
dihydrate equivalent to 8 mg ondansetron.
Excipient with a known effect
Each ml of solution contains 3.52 mg sodium.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless solution, free from visible particles.
Osmolality 270-310 mOsmol/kg
pH of solution 3.0 ‒ 4.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults_
Ondansetron is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy,
and for the prevention and treatment of post‑operative nausea and
vomiting.
_Paediatric population_
IN CHILDREN OVER 6 MONTHS OLD AND ADOLESCENTS ondansetron is indicated
for the management of chemotherapy‑induced
nausea and vomiting.
IN CHILDREN OVER 1 MONTH OLD AND ADOLESCENTS ondansetron is indicated
for the prevention and treatment of post‑operative
nausea and vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The emetogenic potential of cytostatic or radiotherapy varies
depending on the dose level and therapeutic regimen. The
selection of dose regimen should be determined by the severity of the
emetogenic challenge.
Ondansetron is also available for rectal and/or oral administration
and allows the dosage to be individually adjusted. For rectal
or oral administration refer to the relevant product information.
ADULTS
Chemotherapy and radiotherapy induced nausea and vomiting
The recommended dose is 8 mg ondansetron intravenously (IV) or
intramuscularly (IM) immediately