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

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

atracurium (atracurium besylate)

MAH:

Kalceks JSC

ATC_code:

M03AC04

INN:

atracurium (atracurium besylate)

dosage:

10mg/ml

pharmaceutical_form:

solution for injection/infusion

units_in_package:

(5) ampoules 5ml

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2019-03-11

SPC

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