Arduan 4mg powder lyophilized and solvent for solution for injection

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

pipecuronium bromide

Commercializzato da:

Gedeon Richter PLC

Codice ATC:

M03AC06

INN (Nome Internazionale):

pipecuronium bromide

Dosaggio:

4mg

Forma farmaceutica:

powder lyophilized and solvent for solution for injection

Confezione:

(25/5x5/) glass vial 10ml, in blister and (25/5x5/) solvent in ampoules 2ml, in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2015-05-15

Scheda tecnica

SUMMARY
Of'
PRODUCT
CHARACTERISTICS
tor
Arduan
4
mg
powder
and
solvent for solution for injection
L
NAME
OF
THE
MEDICINAL
PRODUCT
Arduan
4
mg
powder
and
solvent for solution for injection
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
4.0 mg pipecuronium bromide in each vial.
For a full list
of
excipients, see section 6.1.
3.
J>HARMACEUTICAL.FORM
Powder
for
solution for injection.
White, almost white lyophilizate.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic
indications
Arduan
is
indicated
a..'>
a
component
of
general
anaesthesia,
to
facilitate
endotracheal
intubation and
to
provide skeletal muscle relaxation.
It
can be used in the course
of
surgery
where muscle relaxation lasting more than 20-30 minutes is required.
4.2
Posology
and
method
of
administration
As in the case for all other neuromuscular blocking agents, the dosage
of
Arduan should be
individualised in each patient.
The method
of
anaesthesia, expected duration
of
surgery,
possible interaction with other drugs that are administered before and
during anaesthesia,
concomitant diseases and present condition
of
the patient should be taken into account when
determining the dose. The use
of
peripheral nerve stimulator is recommended for monitoring
neuromuscular block and recovery.
Arduan
should
be
administered
intravenously.
•
[ni.Jial
doses
of
Arduan
for
intubation and subsequent surgerv
Recommended doses: 0.06-0.08 mg/kg body weight.
With these doses good to excellent intubation '"'',''
1
'tl
and muscle relaxation lasts for approximately 60-90
•
Initial doses
ofArduan
for
surgerv following intubation with succinvlcholine
Recommended doses: 0.05 mg!kg body weight.
With these doses skeletal muscle relaxation lasts for 30-60 minutes.
•
.Qoscs
of
Arduan for the maintenance
ofmuscl_~relaxation
Recommended doses: 0.01-0.02 mg/kg body weight.
These maintenance doses
\Vi1l
prolong muscle relaxation, adequate tor surgery, for
approximately 30-60 minutes.
•
To patients with renal failure doses not higher than 0.04 mg/kg body
weight are
recommended. (Prolongation
of