ONDANSETRON 2 Mg/Ml Solution for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

可用日期:

Claris Lifesciences (UK) Limited

ATC代码:

A04AA01

INN（国际名称）:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

剂量:

2 Mg/Ml

药物剂型:

Solution for Injection

处方类型:

Product subject to prescription which may not be renewed (A)

治疗领域:

Serotonin (5HT3) antagonists

授权状态:

Authorised

授权日期:

2009-11-13

资料单张

The name of your medicine is Ondansetron 2 mg/ml Solution for
Injection, which will be called Ondansetron Injection or
Ondansetron throughout this leaet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaet. You may need to read it again.
-
If you have any further questions about your illness or your
medicine, ask your doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their symptoms are the
same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaet, please tell your doctor,
pharmacist or nurse. This includes any possible side effects
not listed in this leaet. See Section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ondansetron Injection is and what it is used for
2.
What you need to know before you have Ondansetron
Injection
3.
How to have Ondansetron Injection
4.
Possible side effects
5.
How to store Ondansetron Injection
6.
Contents of the pack and other information
1.
WHAT ONDANSETRON INJECTION IS AND WHAT IT IS USED FOR
Ondansetron Injection is a clear solution containing the active
ingredient ondansetron, which is an anti-emetic (prevents nausea
[feeling sick] and vomiting).
Ondansetron Injection is used for:
□
preventing nausea and vomiting caused by chemotherapy (in
adults and children) or radiotherapy for cancer (adults only)
□
preventing nausea and vomiting after surgery.
Ask your doctor, pharmacist or nurse if you would like any further
explanation about these uses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ONDANSETRON
INJECTION
DO NOT HAVE ONDANSETRON INJECTION IF:
□
you are taking apomorphine (used to treat Parkinson's
disease)
□
you are allergic (hypersensitive) to ondansetron or to other
selective 5HT3 receptor antagonists (e.g. granisetron,
dolasetron) or any of the other ingredients in Ondansetron
injection ( listed in section 6).
If you are not sure, talk to yo

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondansetron 2mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg ondansetron as ondansetron hydrochloride
dihydrate.
Each
glass
ampoule
of
2ml
contains
4mg
ondansetron
(as
hydrochloride
dihydrate) in
aqueous
solution
for
intramuscular or intravenous administration.
Each glass ampoule of 5ml
(containing 4 ml
of solution) contains 8mg Ondansetron (as hydrochloride dihydrate) in
aqueous solution for intramuscular or intravenous administration.
Excipients with known effect
Each ml of the solution contains 3.6 mg of Sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection. A clear colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:
Ondansetron 2mg/ml
Solution for
Injection is indicated for
the management
of
nausea and vomiting induced by
cytotoxic chemotherapy and radiotherapy.
Ondansetron injection is indicated for the prevention and treatment of
post-
operative nausea and vomiting (PONV).
_PAEDIATRIC POPULATION:_
Ondansetron injection is indicated for
the management
of
chemotherapy-induced nausea and vomiting (CINV)
in
children aged
6 months, and for the prevention and treatment of PONV in children
aged
1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING.
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 2mg/ml
Solution for Injection or
infusion should be flexible in the range of 8-32 mg a day and selected
as shown below.
_Emetogenic chemotherapy and radiotherapy:_
Ondansetron can be given either by rectal, oral (tablets or syrup),
intravenous or intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy,
Ondansetron 8mg should be administered as a
slow intravenous injection,
(in not
less than 30