Elitan 10mg/2ml, solution for injection

Ország: Málta

Nyelv: angol

Forrás: Malta Medicines Authority

Aktív összetevők:

METOCLOPRAMIDE HYDROCHLORIDE

Beszerezhető a:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC-kód:

A03FA01

INN (nemzetközi neve):

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/ml

Gyógyszerészeti forma:

SOLUTION FOR INJECTION

Összetétel:

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/ml

Recept típusa:

POM

Terápiás terület:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2016-06-21

Betegtájékoztató

pil-metoclinj-3.1-MT
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELITAN 10 MG/2 ML SOLUTION FOR INJECTION
Metoclopramide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Elitan is and what it is used for
2.
What you need to know before you are given Elitan
3.
How to use Elitan
4.
Possible side effects
5.
How to store Elitan
6.
Contents of the pack and other information
1.
WHAT ELITAN IS AND WHAT IT IS USED FOR
Elitan is an antiemetic. It contains a medicine called
“metoclopramide”. It works on a part of your
brain that prevents you from feeling sick (nausea) or being sick
(vomiting).
Adult population
Elitan is used in adults:
- to prevent nausea and vomiting that may occur after surgery
- to treat nausea and vomiting including nausea and vomiting which may
occur with a migraine
- to prevent nausea and vomiting caused by radiotherapy
pil-metoclinj-3.1-MT
Paediatric population
Elitan is used in children (aged 1-18 years) only if other treatment
does not work or cannot be
used:
- to prevent delayed nausea and vomiting that may occur after
chemotherapy
- to treat nausea and vomiting that has occurred after surgery
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ELITAN
DO NOT USE ELITAN IF:
•
If you are allergic to metoclopramide or any of the other ingredients
of this medicine
(listed in section 6).You have bleeding, obstruction or a tear in your
stomach or gut.
•
You have or may have a rare tumour of the adrenal gland, which sits
near the kidney
(pheochromocytoma).
•
You

Termékjellemzők

SPCmetoclinj1.2-MT
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Elitan 10mg/2ml, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide hydrochloride.
Each 2ml ampoule contains metoclopramide hydrochloride equivalent to
10mg of the
anhydrous substance.
Excipient with known effect: 10.470mg/ml benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution for intramuscular or intravenous
administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS ADULT POPULATION
Elitan is indicated in adults for:
- Prevention of post-operative nausea and vomiting (PONV)
- Symptomatic treatment of nausea and vomiting, including acute
migraine induced
nausea and vomiting
- Prevention of radiotherapy induced nausea and vomiting (RINV).
PAEDIATRIC POPULATION
Elitan is indicated in children (aged 1-18 years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a second
line option.
SPCmetoclinj1.2-MT
2
- Treatment of established post-operative nausea and vomiting (PONV)
as a second line
option.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The solution can be administered intravenously or intramuscularly.
Intravenous doses should be administered as a slow bolus (at least
over 3 minutes).
For prevention of PONV a single dose of 10mg is recommended.
For the symptomatic treatment of nausea and vomiting, including acute
migraine induced
nausea and vomiting and for the prevention of radiotherapy induced
nausea and vomiting
(RINV): the recommended single dose is 10 mg, repeated up to three
times daily
The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.
The injectable treatment duration should be as short as possible and
transfer to oral or
rectal treatment should be made as soon as possible.
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to
three times
daily by intravenous route. The maximum dose in 24 hours is 0.5 mg/kg
body weight.
_ _