Nimbex Forte 5mg/ml

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CISATRACURIUM

Fáanlegur frá:

The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC númer:

M03AC11

INN (Alþjóðlegt nafn):

CISATRACURIUM 5 mg/ml

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

CISATRACURIUM 5 mg/ml

Gerð lyfseðils:

POM

Lækningarsvæði:

MUSCLE RELAXANTS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2006-09-18

Upplýsingar fylgiseðill

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  INFORMATION FOR THE PHYSICIAN
   PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS 
(SPC) FOR FURTHER DETAILS ON THIS PRODUCT.
 TRADE NAME OF THE MEDICINAL PRODUCT
  Nimbex 2 mg/ml, solution for injection.
  Nimbex Forte 5 mg/ml, solution for injection
 QUALITATIVE AND QUANTITATIVE COMPOSITION
  Nimbex 2 mg/ml, solution for injection:
   Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml
   one ampoule of 10 ml contains 20 mg of cisatracurium
   one ampoule of 25 ml contains 50 mg of cisatracurium
   Nimbex Forte 5 mg/ml, solution for injection:
   Cisatracurium 5 mg as cisatracurium besilate 6.70 mg per 1 ml
  one vial of 30 ml contains 150 mg of cisatracurium
 PHARMACEUTICAL FORM
   Solution for Injection.
   Colourless to pale yellow or greenish yellow solution. 
Practically free from visible particulate matter.
 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.
 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. 
   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

Vara einkenni

 
Page 1 of 14 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Nimbex Forte 5mg/ml, solution for injection. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Cisatracurium 5mg as cisatracurium besilate 6.70mg per 1ml 

One vial of 30ml contains 150mg 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. 

4.2.1  MONITORING ADVICE 

Page 2 of 14 
As with other neuromuscular blocking agents, monitoring of neuromuscular function is 
recommended during the use of Nimbex in order to individualise dosage requirements. 

4.2.2  USE BY INTRAVENOUS BOLUS INJECTION 

4.2.2.1 DOSAGE IN ADULTS 

TRACHEAL INTUBATION. The recommended intubation dose of Nimbex  for adults is 
0.15mg/kg (body weight). This dose produced good to excellent