ATRACURIUM BESILATE 10 Micromol Solution for Injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

ATRACURIUM BESILATE

Fáanlegur frá:

HOSPIRA UK Ltd

INN (Alþjóðlegt nafn):

ATRACURIUM BESILATE

Skammtar:

10 Micromol

Lyfjaform:

Solution for Injection

Gerð lyfseðils:

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

Leyfisstaða:

Authorised

Leyfisdagur:

0000-00-00

Upplýsingar fylgiseðill

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 TAKING 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. 
Before you are given Atracurium Besilate Solution for Injection 
3. 
How you are given Atracurium Besilate Solution for Injection 
4. 
Possible side effects 
5. 
How to store Atracurium Besilate Solution for Injection 
6. Further 
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. 
BEFORE YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION FOR 
INJECTION 

YOU WILL NOT BE GIVEN 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) 

TAKE SPECIAL CARE WITH 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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atracurium Besilate 10 mg/ml Solution for Injection, ampoules.
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
For a 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).
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), gi