Ondansetron 2mg/ml Solution for Injection or Infusion (2ml amp)

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Активни састојак:

ONDANSETRON HYDROCHLORIDE, DIHYDRATE

Доступно од:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

АТЦ код:

A04AA01

INN (Међународно име):

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2 mg/ml

Фармацеутски облик:

SOLUTION FOR INJECTION/INFUSION

Састав:

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2 mg/ml

Тип рецептора:

POM

Терапеутска област:

ANTIEMETICS AND ANTINAUSEANTS

Статус ауторизације:

Withdrawn

Датум одобрења:

2019-04-09

Информативни летак

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
(ONDANSETRON)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS
ADMINISTERED TO YOU BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
• IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
• 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 Solution for Injection is and what it is used for
2. What you need to know before Ondansetron Solution for Injection is
administered
3. How to administer Ondansetron Solution for Injection
4. Possible side effects
5. How to store Ondansetron Solution for Injection
6. Contents of the pack and other information
The name of your medicine is Ondansetron 2mg/ml Solution for Injection
or Infusion (also referred
to as Ondansetron injection or Ondansetron throughout this leaflet).
1. WHAT ONDANSETRON SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Ondansetron injection contains a medicine called ondansetron. This
belongs to a group of medicines
called anti-emetics.
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, nurse or pharmacist if you would like any further
explanation about these uses.
2. WHAT YOU NEED TO KNOW BEFORE ONDANSETRON SOLUTION FOR INJECTION IS
ADMINISTERED
DO NOT HAVE_ _ONDANSETRON SOLUTION FOR INJECTION
• if you are taking apomorphine (used to treat Parkinson’s
disease).
• if you are allergic to ondansetron or any of the other ingredients
in Ondansetron
Injection (listed in Section 6).
_ _
If you are not sure, talk to your doctor, nurse or pharmacist before
having Ondansetron injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or p

Карактеристике производа

Page
1
of
17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ondansetron 2mg/ml Solution for Injection or Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2mg of ondansetron (as hydrochloride dihydrate)
Each 2ml ampoule contains 4mg of ondansetron (as hydrochloride
dihydrate)
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection or Infusion
Clear, colourless solution, free from particles
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Adults
Ondansetron hydrochloride is indicated for the management of nausea
and vomiting
induced by cytotoxic chemotherapy and radiotherapy. Ondansetron
hydrochloride is for the
prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric Population
Ondansetron hydrochloride 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 hydrochloride should be flexible in the range of 8-32mg a
day and selected as
shown below.
_Emetogenic chemotherapy and radiotherapy_
: Ondansetron hydrochloride can be given
either by rectal, oral (tablets or syrup), intravenous or
intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy,
Ondansetron
hydrochloride 8mg should be administered as a slow intravenous or
intramuscular injection
immediately before treatment, followed by 8 mg orally twelve hourly.
Page
2
of
17
To protect against delayed or prolonged emesis after the first 24
hours, oral or rectal
treatment with Ondansetron hydrochloride should be continued for up to
five days after a
course of treatment.
_Highly emetogenic chem