Atracurium besilate 50mg/5ml solution for injection ampoules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Atracurium besilate

Доступна с:

Pfizer Ltd

код АТС:

M03AC04

ИНН (Международная Имя):

Atracurium besilate

дозировка:

10mg/1ml

Фармацевтическая форма:

Solution for injection

Администрация маршрут:

Intravenous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 15010500; GTIN: 5015997143758

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR INJECTION
The active substance is atracurium besilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Atracurium Besilate Solution for Injection is and what it is used
for
2.
What you need to know before you use Atracurium Besilate Solution for
Injection
3.
How to use Atracurium Besilate Solution for Injection
4.
Possible side effects
5.
How to store Atracurium Besilate Solution for Injection
6.
Contents of the pack and other information
1.
WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND
WHAT IT IS USED FOR
Atracurium Besilate Solution for Injection is a medicine which acts as
a muscle relaxant.
Atracurium Besilate Solution for Injection 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 in patients in intensive care.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM
BESILATE SOLUTION FOR INJECTION
DO NOT USE ATRACURIUM BESILATE SOLUTION FOR INJECTION
-
IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO ATRACURIUM BESILATE
or any of the other
ingredients of this drug (see section 6)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING ATRACURIUM
BESILATE SOLUTION FOR
INJECTION IF YOU
-
are pregnant or breast-feeding (see Pregnancy and breast-feeding)
-
have
HEART OR CIRCULATION PROBLEMS
-
have
PROBLEMS WITH YOUR LUNGS
-
have a
HISTORY OF ALLERGY OR ASTHMA
-
suffer from
MYASTHENIA GRAVIS, EATON-LAMBERT SYNDROME OR OTHER NEUROMUSCULAR
DISEASES
(these may result in muscle weakness)
-
have
SEVERE ELECTROLYTE DISORDERS
(unusual levels of ions such as sodium, potassium or
chloride in your blood)
-
are
SUF

Характеристики продукта

OBJECT 1
ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR
INJECTION - VIAL
Summary of Product Characteristics Updated 31-Jan-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Atracurium Besilate 10 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Atracurium besilate 10 mg/ml (equivalent to atracurium 7.5 mg/ml)
2.5 ml of solution contains 25 mg atracurium besilate
5 ml of solution contains 50 mg atracurium besilate
25 ml of solution contains 250 mg atracurium besilate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
A clear colourless or faint yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Atracurium Besilate Injection is indicated as an adjunct to general
anaesthesia during surgery to relax
skeletal muscles, and to facilitate endotracheal intubation and
mechanical ventilation. It is also indicated
to facilitate mechanical ventilation in intensive care unit (ICU)
patients.
4.2 Posology and method of administration
USE AS AN ADJUNCT TO GENERAL ANAESTHESIA
Atracurium Besilate Injection should only be administered by
intravenous injection. DO NOT GIVE
ATRACURIUM BESILATE INJECTION INTRAMUSCULARLY since this may result in
tissue irritation and there are no
clinical data to support this route of administration.
To avoid distress to the patient, Atracurium Besilate Injection should
not be administered before
unconsciousness has been induced.
Atracurium Besilate Injection should not be mixed in the same syringe,
or administered simultaneously
through the same needle, with alkaline solutions (e.g. barbiturate
solutions).
See section 6.6 for a list of compatible infusion solutions.
In common with all neuromuscular blocking agents, monitoring of
neuromuscular function is
recommended during the use of Atracurium Besilate Injection in order
to individualise dosage
requirements.
Initial bolus doses for intubation
An initial atracurium besilate dose of 0.3 to 0.6 mg/kg (depending on
the duration of full block required),
given as an intrav