TRACRIUM

Land: Indonesia

Språk: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv ingrediens:

ATRACURIUM BESILATE

Tilgjengelig fra:

MITSUBISHI TANABE PHARMA INDONESIA - Indonesia

INN (International Name):

ATRACURIUM BESILATE

Dosering :

50 MG

Legemiddelform:

INJEKSI

Enheter i pakken:

DUS, 5 AMPUL @ 5 ML

Produsert av:

ASPEN SVP (PTY) LTD - South Africa

Autorisasjon dato:

2021-12-23

Preparatomtale

TRACRIUM
ATRACURIUM BESYLATE
INJECTION 10MG/ML
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
_INJECTION:_
A sterile solution containing 10 mg atracurium besylate per mL,
without an antimicrobial preservative, supplied in ampoules.
2. PHARMACEUTICAL FORM
Solution for injection or infusion.
3. CLINICAL PARTICULARS
3.1 INDICATIONS
_TRACRIUM_ is a highly selective, competitive or non-depolarising
neuromuscular blocking agent which is used as an adjunct to general
anaesthesia to enable
tracheal intubation. _TRACRIUM_ injection is also used to be performed
and to relax skeletal muscles during surgery or controlled
ventilation, and to facilitate
mechanical ventilation in Intensive Care Unit (ICU) patients.
3.2 DOSAGE AND ADMINISTRATION
In common with all neuromuscular blocking agents monitoring of
neuromuscular function is recommended during the use of _TRACRIUM_ in
order to individualise
dosage requirements.
• USE BY INJECTION IN ADULTS
_TRACRIUM_ is administered by intravenous (i.v.)_ _injection. The
dosage range for adults is
0.3 to 0.6 mg/kg (depending on the duration of full block required)
and will provide adequate relaxation for 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the i.v. injection of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.l to 0.2
mg/kg as required. Successive supplementary dosing does not give rise
to accumulation of
neuromuscular blocking effect.
Spontaneous recovery from the end of full block occurs in about 35
minutes as measured by the restoration of the tetanic response to 95%
of normal
neuromuscular function.
The neuromuscular block produced by _TRACRIUM_ can be rapidly reversed
by standard doses of anticholinesterase agents, such as neostigmine
and
edrophonium, accompanied or preceded by atropine, with no evidence of
recurarisation.
• USE AS AN INFUSION IN ADULTS
After an initial bolus dose of 0.3 to 0.6 mg/kg, _TRACRIUM_ can be
used to maintain neuromuscular block during long surgical procedures
by administr