Nimbex 2mg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CISATRACURIUM

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

M03AC11

INN (International Name):

CISATRACURIUM 2 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CISATRACURIUM 2 mg/ml

Prescription type:

POM

Therapeutic area:

MUSCLE RELAXANTS

Authorization status:

Withdrawn

Authorization date:

2005-10-17

Patient Information leaflet

Summary of Product Characteristics
N I M B E X
™
 cisatracurium 
besilate
1  NAME OF THE MEDICINAL PRODUCT
Nimbex 2 mg/ml, Solution for Injection.
2  QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml
one ampoule of 2.5 ml contains 5 mg of cisatracurium
one ampoule of 5 ml contains 10 mg of cisatracurium 
one ampoule of 10 ml contains 20 mg of cisatracurium 
one ampoule of 25 ml contains 50 mg of cisatracurium 
For excipients, see Section 6.1.
3 PHARMACEUTICAL 
FORM
Solution for Injection.
Colourless to pale yellow or greenish yellow solution. Practically
free from visible 
particulate matter.
4 CLINICAL 
PARTICULARS
Nimbex is an intermediate-duration, non-depolarising neuromuscular
blocking agent for 
intravenous administration.
4.1 THERAPEUTIC INDICATIONS
Nimbex is indicated for use during surgical and other procedures and
in intensive care. 
Nimbex can be used as an adjunct to general anaesthesia, or sedation
in the Intensive 
Care Unit (ICU) to relax skeletal muscles, and to facilitate tracheal
intubation and 
mechanical ventilation.
4.2  POSOLOGY AND METHOD OF ADMINISTRATION
Please note that Nimbex should not be mixed in the same syringe or
administered 
simultaneously through the same needle as propofol injectable emulsion
or with alkaline 
solutions such as sodium thiopentone (see section 6.2).
Nimbex contains no antimicrobial preservative and is intended for
single patient use.
MONITORING ADVICE
As with other neuromuscular blocking agents, monitoring of
neuromuscular function is 
recommended during the use of Nimbex in order to individualise dosage
requirements.
USE BY INTRAVENOUS BOLUS INJECTION
DOSAGE IN ADULTS
Tracheal Intubation. The recommended intubation dose of Nimbex for
adults is 
0.15 mg/kg (body weight). This dose produced good to excellent
conditions for tracheal 
intubation 120 seconds after administration of Nimbex, following
induction
of anaesthesia with propofol.
Higher doses will shorten the time to onset

Summary of Product characteristics

Page 1 of 15 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Nimbex® 2mg/ml, solution for injection. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Cisatracurium 2mg as cisatracurium besilate 2.68mg per 1ml 

One ampoule of 2.5ml contains 5mg of cisatracurium 
One ampoule of 5ml contains 10mg of cisatracurium 
One ampoule of 10ml contains 20mg of cisatracurium 
One ampoule of 25ml contains 50mg of cisatracurium 

For excipients, see Section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for Injection. 

Colourless to pale yellow or greenish yellow solution. Practically free from visible 
particulate matter. 

4. 
CLINICAL PARTICULARS 

Nimbex is an intermediate-duration, non-depolarising neuromuscular blocking agent for 
intravenous administration. 

4.1 
THERAPEUTIC INDICATIONS 

Nimbex is indicated for use during surgical and other procedures and in intensive care. 
Nimbex can be used as an adjunct to general anaesthesia, or sedation in the Intensive Care 
Unit (ICU) to relax skeletal muscles, and to facilitate tracheal intubation and mechanical 
ventilation. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Please note that Nimbex should not be mixed in the same syringe or administered 
simultaneously through the same needle as propofol injectable emulsion or with alkaline 
solutions such as sodium thiopentone. (see  section 6.2). 

Nimbex contains no antimicrobial preservative and is intended for single patient use. 

Monitoring advice 

Page 2 of 15 

As with other neuromuscular blocking agents, monitoring of neuromuscular function is 
recommended during the use of Nimbex in order to individualise dosage requirements. 

USE BY INTRAVENOUS BOLUS INJECTION 

DOSAGE IN ADULTS 

TRACHEAL