Cisatracurium-AFT

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Cisatracurium besilate 0.268%{relative} equivalent to cisatracurium 0.2% w/v

Beschikbaar vanaf:

AFT Pharmaceuticals Ltd

INN (Algemene Internationale Benaming):

Cisatracurium besilate 0.268% w/v (equivalent to cisatracurium 0.2% w/v)

Dosering:

2 mg/mL

farmaceutische vorm:

Solution for injection

Samenstelling:

Active: Cisatracurium besilate 0.268%{relative} equivalent to cisatracurium 0.2% w/v Excipient: Benzenesulfonic acid Water for injection

Prescription-type:

Prescription

Geproduceerd door:

Yonsung Fine Chemicals Co. Limited

therapeutische indicaties:

Cisatracurium-AFT is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

Product samenvatting:

Package - Contents - Shelf Life: Ampoule, Type I glass - 10 ml - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, Type I glass - 5 ml - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, Type I glass - 2.5 ml - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, Type I glass - 10 ml - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, Type I glass - 5 ml - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, Type I glass - 2.5 ml - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisatie datum:

2013-05-13

Productkenmerken

PRODUCT INFORMATION
CISATRACURIUM-AFT
AFT PHARMACEUTICALS PTY LTD
NAME OF THE DRUG
Cisatracurium-AFT contains Cisatracurium besylate
The chemical name of cisatracurium besylate is
(1R,1’R,2R,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 molecular formula of
cisatracurium
besylate is C
65
H
82
N
2
O
18
S
2
and it has a molecular weight of 1243.5. The structural
formula is given below:
CAS Number: 96946-42-8
DESCRIPTION
Cisatracurium besylate is a white to yellowish powder.
Cisatracurium-AFT is supplied in two strengths, either 2 mg or 5 mg
(as the besylate
salt) of cisatracurium besylate per mL. Cisatracurium-AFT also
contains Water for
Injections
and
benzenesulfonic
acid.
Cisatracurium-AFT
does
not
contain
any
antimicrobial preservative and is intended for single patient use on
one occasion only.
Discard any residue.
PHARMACOLOGY
_PHARMACODYNAMICS _
Cisatracurium besylate, a stereoisomer of atracurium, is an
intermediate duration, non-
depolarising benzylisoquinolinium skeletal muscle relaxant.
Cisatracurium besylate binds
to cholinergic receptors on the motor end-plate to antagonise the
action of acetylcholine,
resulting in a competitive block of neuromuscular transmission. This
action is readily
reversed by anticholinesterase agents such as neostigmine.
1
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 3 x ED
95
,
which has a longer clinically effective duration than the recommended
intubation dose of
atracurium (2 x ED
95
) (see DOSAGE AND ADMINISTRATION).
The ED
95
of cisatracurium besylate in children during halothane anaesthesia is
0.04
mg/kg bodyweight.
Cisatracurium besylate undergoes degradation in the body at
physio