Cisatracurium SXP

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

קנה את זה

הורד עלון מידע (PIL)
30-05-2024
הורד מאפייני מוצר (SPC)
30-05-2024

מרכיב פעיל:

Cisatracurium besylate

זמין מ:

Southern Cross Pharma Pty Ltd

סיווג:

Medicine Registered

עלון מידע

                                ________________________________________________________________________________ 
C: Products/Cisatracurium/CMI SXP oct12            
 14/10/12                                  
                                    Page 1
of 2
 
 
CISATRACURIUM SXP INJECTION SOLUTION 
_cisatracurium (as besylate) _
 
CONSUMER MEDICINE INFORMATION   
 
 
 
 
 
_ _
 
 
What is in this leaflet 
 
This leaflet answers some common 
questions about CISATRACURIUM 
SXP. It does not contain all of the 
available information. 
 
Reading this leaflet does not take the 
place of talking to your doctor or 
pharmacist. 
 
Taking any medicine involves some 
risk. It is possible that all risks 
associated with this medicine might not 
have been detected, despite proper 
testing. Only your doctor or pharmacist 
is able to weigh up all of the relevant 
facts, and you should consult them if 
you have any queries. 
 
If you have any concerns about the use 
of CISATRACURIUM SXP ask your 
doctor or pharmacist. 
 
KEEP THIS INFORMATION.  
You may want to read it again. 
 
This leaflet provides information about 
CISATRACURIUM SXP. The 
statements that are made in this leaflet 
cannot be applied to any other 
medicine, even those that are similar or 
appear to contain the same ingredients. 
 
What CISATRACURIUM 
SXP is used for 
 
CISATRACURIUM SXP is used to 
relax the body's muscles. 
CISATRACURIUM SXP will 
normally be given to you when you are 
in surgery, or during other medical 
procedures. CISATRACURIUM SXP 
is only used in conjunction with an 
anaesthetic, so you will be asleep 
during the procedure. 
 
If you have any questions about why 
CISATRACURIUM SXP is used ask 
your doctor. 
 
How does 
CISATRACURIUM SXP 
work? 
 
Cisatracurium besylate (the active 
ingredient in CISATRACURIUM 
SXP) belongs to a group of medi
                                
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מאפייני מוצר

                                C:Products/Cisatracurium/PI SXP 19apr13 TGA aprvd    
  19/4/13 
Page 1 of 15
PRODUCT INFORMATION
 
CISATRACURIUM SXP INJECTION SOLUTION 
 
NAME OF THE MEDICINE 
 
Cisatracurium (as besylate)  
 
Chemical name:
(1_R_,1'_R_,2_R_,2'_R_)-2,2'-(3,11-Dioxo-4,10-dioxatridecamethylene)
bis-
(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-
veratrylisoquinolinium) 
dibenzenesulfonate. 
_ _
The chemical structure of cisatracurium besylate is: 
 
 
 
Cisatracurium besylate 
 
Molecular formula: C
65
H
82
N
2
O
18
S
2  
                        MW:  1,243.5 
 
CAS number: 96946-42-8 
 
DESCRIPTION  
 
Cis-atracurium besylate is a white to off white powder 
 
The injection solution contains benzenesulfonic acid, Water for
Injections and is 
preservative free. 
 
PHARMACOLOGY 
 
Cisatracurium besylate, a stereoisomer of atracurium, is an
intermediate duration, 
nondepolarising benzylisoquinolinium skeletal muscle relaxant. 
 
PHARMACODYNAMICS 
 
Cisatracurium besylate binds to cholinergic receptors on the motor
endplate to 
antagonise the action of acetylcholine, resulting in a competitive
block of 
C:Products/Cisatracurium/PI SXP 19apr13 TGA aprvd    
  19/4/13 
Page 2 of 15
neuromuscular transmission. This action is readily reversed by
anticholinesterase 
agents such as neostigmine. 
 
The ED
95
 (dose required to produce 95% depression of the twitch response of
the 
adductor pollicis muscle to stimulation of the ulnar nerve) of
cisatracurium besylate is 
estimated to be 0.05 mg/kg bodyweight during opioid anaesthesia
(thiopentone, 
fentanyl, midazolam). The recommended intubation dose for
cisatracurium in adults is 
three times the ED
95
, which has a longer clinically effective duration than the 
recommended intubation dose of atracurium (two times the ED
95
) (see Dosage and 
Administration). 
 
The ED
95
 of cisatracurium besylate in children during halothane anaesthesia
is 0.04 
mg/kg bodyweight. 
  
PHARMACOKINETICS 
 
C
                                
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