Atracurium besilate 10 mg/ml solution for injection/infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Atracurium besilate

Boleh didapati daripada:

AS Kalceks

Kod ATC:

M03AC; M03AC04

INN (Nama Antarabangsa):

Atracurium besilate

Dos:

10 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection/infusion

Jenis preskripsi:

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

Kawasan terapeutik:

Other quaternary ammonium compounds; atracurium

Status kebenaran:

Marketed

Tarikh kebenaran:

2017-11-24

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR INJECTION/INFUSION
atracurium besilate
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 nurse.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Atracurium Besilate is and what it is used for
2.
What you need to know before you receive Atracurium Besilate
3.
How to use Atracurium Besilate
4.
Possible side effects
5.
How to store Atracurium Besilate
6.
Contents of the pack and other information
1.
WHAT ATRACURIUM BESILATE IS AND WHAT IT IS USED FOR
Atracurium Besilate belongs to a group of medicines called muscle
relaxants.
Atracurium Besilate is used during surgery to relax muscles and to
assist with inserting a breathing
tube and with artificial breathing. It is also used to help with
artificial breathing at patients in intensive
care units.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ATRACURIUM BESILATE
ATRACURIUM BESILATE CANNOT BE ADMINISTERED:
-
if you are
allergic to atracurium besilate, cisatracurium or any of the other
ingredients of this
medicine (listed in section 6).
If you think that this applies to you talk to your doctor before
Atracurium Besilate is administered to
you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Atracurium Besilate
-
if you have an allergy or bronchial asthma;
-
if you have ever had an allergic reaction to other medicines similar
to Atracurium Besilate that
blocks the transmission of impulses between a nerve and muscle;
-
if you suffer from muscle weakness, tiredness or difficulty in
coordination of movements
(
_myasthenia gravis_
);
-
if you suffer from a neuromuscular disease;
-
if you have a heart disease or you are sensitive to a drop in blood
pressure;
-
if you have

Ciri produk

Health Products Regulatory Authority
02 September 2022
CRN00CT4N
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atracurium besilate 10 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 10 mg of atracurium besilate.
Each ampoule (2.5 ml) contains 25 mg of atracurium besilate.
Each ampoule (5 ml) contains 50 mg of atracurium besilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless or yellowish solution, free from visible particles.
pH of solution is 3.30 to 3.65 and osmolality is 10 – 30 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is used as an adjunct to general anaesthesia to
facilitate tracheal intubation, to relax skeletal muscles during
surgery or controlled ventilation, and to facilitate mechanical
ventilation of patients in the intensive care unit.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_ _
_Dosage by intravenous injection _
Atracurium besilate is administered by intravenous injection. The
usual dose for adults ranges from 0.3 to 0.6 mg/kg of body
weight (depending on the required duration of full block) and provides
adequate relaxation for 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.
Caesarean Section:
Atracurium besilate is suitable for maintenance of muscle relaxation
during Caesarean section as it does not cross the placenta
in clinically significant amounts following recommended doses
(0.3‑0.6 mg/kg).
Spontaneous recovery of normal muscle tone occurs after approximately
35 minutes when neuromuscular function restored to
95 % of its baseline (measured by the restoration of the tetanic
response).
The neuromuscul