METOCLOPRAMIDE 5mg/ml Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METOCLOPRAMIDE HYDROCHLORIDE

Available from:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

A03FA01

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/ml

Prescription type:

POM

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-12-18

Patient Information leaflet

Package leaflet: Information for the patient
METOCLOPRAMIDE 5MG/ML SOLUTION FOR INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
The product is known by METOCLOPRAMIDE 5mg/ml Solution for Injection
but will be referred to as Metoclopramide Injection throughout the
rest of this leaflet.
WHAT IS IN THIS LEAFLET
1. What Metoclopramide Injection is and what it is used for
2. What you need to know before you are given Metoclopramide Injection
3. How you will be given metoclopramide Injection
4. Possible side effects
5. How to store Metoclopramide Injection
6. Contents of the pack and other information
1. WHAT METOCLOPRAMIDE INJECTION IS AND WHAT IT IS USED FOR
Metoclopramide Injection 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
Metoclopramide Injection 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.
Paediatric population
Metoclopramide Injection 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 METOCLOPRAMIDE INJECTION
DO NOT USE METOCLOPRAMIDE INJECTION
•
if you are allergic to Metoclopramide or any of the other ingredients
of this medicine (listed in section 6)
•
if you are breast-feeding
•
if you have bleeding, obstruction or a tear in your stomach or gut
•
if you have had a stomach or bowel operation within the previous four
days
•
if you have or may have a rare tumour of the adrenal gland, which sits
near the kidney (pheochromocytoma)
•
if you have ever had involuntary muscle spasms (tardive dyskinesia),
when you have been treated with a medicine
•
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
METOCLOPRAMIDE 5mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2m1 contains 5.27mg (0.527% w/v) Metoclopramide Hydrochloride BP
equivalent to 10mg Anhydrous Metoclopramide Hydrochloride.
Excipients with known effect
Sodium metabisulphite- 1 mg (0.100 % w/v)
Sodium: 0.376mg/2ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult population
Metoclopramide 5mg/ml Solution for Injection 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
Metoclopramide 5mg/ml Solution for Injection is indicated in children
(aged 1-18
years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a
second line option
- 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).
All indications (adult population)
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.
All indications (paediatric population aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body w