Atracurium Besylate Injection solution for injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

atracurium (atracurium besylate)

Доступна с:

Swiss Parenterals Ltd.

код АТС:

M03AC04

ИНН (Международная Имя):

atracurium (atracurium besylate)

дозировка:

10mg/ml

Фармацевтическая форма:

solution for injection

Штук в упаковке:

(5) ampoules 5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2022-04-12

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atracurium Besylate Injection 10 mg/ml, 5 ml
1.1
PRODUCT NAME
Atracurium Besylate Injection 10 mg/ml, 5 ml
1.2
STRENGTH
10 mg/ml
1.3
PHARMACEUTICAL DOSAGE FORM
Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
QUALITATIVE DECLARATION
Each ml contains:
Atracurium Besylate
2.2
QUANTITATIVE DECLARATION
Each ml contains:
Atracurium Besylate 10 mg
Water for Injections q.s.
3.
PHARMACEUTICAL FORM
Solution for Injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atracurium
Besylate
Injection
is
a
highly
selective,
competitive
or
non-
depolarising neuromuscular blocking agent, which is used as an adjunct
to general
anaesthesia to enable tracheal intubation to be performed and to relax
skeletal
muscles during surgery or controlled ventilation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Children: The dosage in children over the age of one month is the same
as that in
adults on a bodyweight basis
Elderly: Atracurium Besylate Injection may be used at standard dosage
in elderly
patients. It is recommended, however, that the initial dose be at the
lower end of
the range and that it be administered slowly.
Patients
with
reduced
renal
and/or
hepatic
function:
Atracurium
Besylate
Injection may be used at standard dosage at all levels of renal or
hepatic function,
including endstage failure.
Patients
with
cardiovascular
disease:
In
patients
with
clinically
significant
cardiovascular disease, the initial dose of Atracurium Besylate
Injection should be
administered over a period of 60 seconds.
Monitoring: In common with all neuromuscular blocking agents
monitoring of
neuromuscular function is recommended during the use of Atracurium
Besylate
Injection in order to individualise dosage requirements.
MODE OF ADMINISTRATION:
Injection:
Atracurium
Besylate
Injection is administered by
intravenous injection. The
dosage range for adults is 0.3 to 0.6 mg/kg (depending on the duration
of full
block required) and will provide adequate relaxation f