Atracurium 10 mg/ml solution for injection/infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Atracurium besilate

Disponível em:

Hikma Farmacêutica (Portugal) S.A.

Código ATC:

M03AC; M03AC04

DCI (Denominação Comum Internacional):

Atracurium besilate

Dosagem:

10 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection/infusion

Tipo de prescrição:

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

Área terapêutica:

Other quaternary ammonium compounds; atracurium

Status de autorização:

Not marketed

Data de autorização:

2014-07-04

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATRACURIUM 10 MG/ML SOLUTION FOR INJECTION/INFUSION
Atracurium besilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING
ATRACURIUM.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What Atracurium is and what it is used for
2. What you need to know before you take Atracurium
3. How to take Atracurium
4. Possible side effects
5. How to store Atracurium
6. Contents of the pack and other information
1.
WHAT ATRACURIUM IS AND WHAT IT IS USED FOR
The active substance in Atracurium is atracurium besilate, This
belongs to a group of medicines
called muscle relaxants.
Atracurium is used:
• to relax muscles during operations on adults and children over 1
month of age
• to help insert a tube into the windpipe (tracheal intubation), if
a person needs help to breathe
• to relax the muscles of adults in intensive care
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATRACURIUM
DO NOT TAKE ATRACURIUM IF:
• you are allergic to atracurium besilate, any other muscle relaxant
or any of the other
ingredients in Atracurium (listed in Section 6)
• you have reacted badly to an anaesthetic before.
Do not take Atracurium if any of the above applies to you.
If you are not sure, talk to your doctor, nurse or pharmacist before
you have Atracurium.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before receiving Atracurium.
• you have muscle weakness, tiredness or difficulty in co-ordinating
your movements
(myasthenia gravis)
• you have a neuromuscular disease, such as a muscle wasting
disease, paralysis, motor neurone
disease or cerebral palsy
• you have a burn which requires medical treatment
• you have ever had an allergic reaction to any muscle relaxant
which was given as part of an
operation
• you have a history of sensitiv

Características técnicas

Health Products Regulatory Authority
19 December 2022
CRN00CR5T
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atracurium 10 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 10 mg of atracurium besilate.
Each 2.5 ml ampoule contains 25 mg of atracurium besilate
Each 5 ml ampoule contains 50 mg of atracurium besilate
Each 25 ml vial contains 250 mg of atracurium besilate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or Infusion
Clear and colourless solution
pH: 3.25 – 3.65
Osmolality: 10 – 30 mOsmol/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atracurium is a highly selective, competitive or non-depolarising
neuromuscular blocking agent. It is used as an adjunct to
general anaesthesia or sedation in the intensive care unit (ICU), to
relax skeletal muscles, and to facilitate tracheal intubation
and mechanical ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADMINISTRATION BY INJECTION IN ADULTS
Route of administration: Intravenous injection or continuous infusion.
Atracurium is administered by intravenous injection. The dosage range
recommended for adults is 0.3 to 0.6 mg/kg
(depending on the duration of full block required) and will provide
adequate relaxation for about 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous injection of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to 0.2
mg/kg as required. Successive supplementary dosing does
not give rise to accumulation of neuromuscular blocking effect.
Spontaneous recovery from the end of full block occurs in about 35
minutes as measured by the restoration of the tetanic
response to 95% of normal neuromuscular function.
The neuromuscular block produced by Atracurium can be rapidly reversed
by standard doses of anticholinesterase agents, such
as neostigmine and edrophonium, accompanied or preceded by atropine,
with no evidenc