Meptid 100 mg/ml Solution for Injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Meptazinol

Disponibil de la:

Almirall, S.A.

Codul ATC:

N02AX; N02AX05

INN (nume internaţional):

Meptazinol

Dozare:

100 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Other opioids; meptazinol

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1983-10-10

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEPTID 100 MG/ML SOLUTION FOR INJECTION
Meptazinol
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 phamacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Meptid Injection is and what it is used for
2.
What you need to know before you use Meptid Injection
3.
How to use Meptid Injection
4.
Possible side effects
5.
How to store Meptid Injection
6.
Contents of the pack and other information
THIS MEDICINE CONTAINS MEPTAZINOL WHICH IS AN OPIOID, WHICH CAN CAUSE
ADDICTION. YOU CAN GET
WITHDRAWAL SYMPTOMS IF YOU STOP USING IT SUDDENLY.
1.
WHAT MEPTID INJECTION IS AND WHAT IT IS USED FOR
This medicine has been prescribed for you for the treatment of
moderate to severe pain, including post-
operative pain and the pain of renal colic. It contains meptazinol
which belongs to a class of medicines
called opioids, which are ‘pain relievers’. This medicine has been
prescribed to you and should not be given
to anyone else. Opioids can cause addiction and you may get withdrawal
symptoms if you stop using it
suddenly. Your prescriber should have explained how long you will be
using it for and when it is
appropriate to stop, how to do this safely.
The name of this medicine is Meptid 100 mg/ml Solution for Injection
but will be referred to as Meptid
Injection throughout the remainder of the leaflet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEPTID INJECTION
DO NOT USE MEPTID INJECTION IF YOU
-
are allergic to Meptazinol or any of the other ingredients of this
medicine (listed in Section 6)
-
have any alcohol-related problems
-

Caracteristicilor produsului

Health Products Regulatory Authority
28 January 2022
CRN00CS57
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meptid 100 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 100 mg of meptazinol (as
hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear colourless solution free from particulate matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of moderate to severe pain, including post-operative
pain, obstetric pain and the pain of renal colic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a strategy for ending
treatment with meptazinol in order to minimise the risk of addiction
and drug withdrawal syndrome (see section 4.4).
Posology
ADULTS
Intramuscular dosage: 75 to 100 mg meptazinol. This injection may be
repeated 2 to 4 hourly as required. For obstetric pain a
dose of 100 to 150 mg should be used according to weight. This dose
should approximate 2 mg/kg.
Intravenous dosage: 50 to 100 mg meptazinol by slow intravenous
injection. The injection may be repeated 2 to 4 hourly as
required. If vomiting occurs, a suitable antiemetic should be given.
Epidural/intrathecal use: this formulation is not suitable for these
routes.
ELDERLY
The adult dosage schedule can be used in the elderly.
PAEDIATRIC POPULATION
No data are available
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Patients with the following conditions:
● acute alcoholism and where there is a risk of paralytic ileus
● raised intracranial pressure or head injury (in addition to
interfering with respiration, affects pupillary responses vital
for neurological assessment)
Health Products Regulatory Authority
28 January 2022
CRN00CS57
Page 2 of 6
● phaeochromocytoma (risk of pressor response to histamine release)
● acut