Atracurium Besylate 10mg/ml Solution for Injection/Infusion solution for injection/infusion

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

atracurium (atracurium besylate)

Beschikbaar vanaf:

Kalceks JSC

ATC-code:

M03AC04

INN (Algemene Internationale Benaming):

atracurium (atracurium besylate)

Dosering:

10mg/ml

farmaceutische vorm:

solution for injection/infusion

Eenheden in pakket:

(5) ampoules 2,5ml

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2022-11-03

Bijsluiter

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 s

Productkenmerken

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 neuromuscular block produced by atracurium besilate can be rapidly
reversed by standa