Maxolon 5 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metoclopramide hydrochloride

Available from:

Amdipharm Limited

ATC code:

A03FA; A03FA01

INN (International Name):

Metoclopramide hydrochloride

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Propulsives; metoclopramide

Authorization status:

Not marketed

Authorization date:

1994-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MAXOLON
® 5 MG/ML SOLUTION FOR INJECTION
metoclopramide hydrochloride
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 or nurse.
- 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 nurse. This
includes any possible side effects not listed in
this leaflet. See section 4.
The product is known by name above but will be referred to as Maxolon
Injection throughout the rest of this
leaflet.
WHAT IS IN THIS LEAFLET
1. What Maxolon injection is and what it is used for
2. What you need to know before you are given Maxolon Injection.
3. How you will be given Maxolon Injection
4. Possible side effects
5. How to store Maxolon Injection
6. Contents of the pack and other information
1. WHAT MAXOLON INJECTION IS AND WHAT IT IS USED FOR
Maxolon 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
Maxolon 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
Maxolon 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 MAXOLON INJECTION
YOU MUST NOT BE GIVEN MAXOLON INJECTION:
- if you are allergic to metoclopramide hydrochloride or any of the
other ingredients of this medicine (

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2022
CRN00CZYN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxolon 5 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains metoclopramide hydrochloride monohydrate
equivalent to 10 mg of the anhydrous substance.
Excipient(s) with known effect:
Sodium Metabisulphite (E223)- 2.96 mg
Sodium- 6.22 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULT POPULATION
Maxolon 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
Maxolon 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
Metoclopramide should not be used in children younger than 1 year as
there are insufficient data regarding efficacy and safety
of the product in this population.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ROUTE OF ADMINISTRATION
The solution can be administered intravenously or intramuscularly.
Intravenous doses should be administered as a slow bolus (at least
over 3 minutes).
Health Products Regulatory Authority
14 September 2022
CRN00CZYN
Page 2 of 9
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 andvomiting and for the
prevention of radiotherapy induced nausea and vomiting (RINV):
therecommended 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 shoul