Arduan powder lyophilized and solvent for solution for injection

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

pipecuronium bromide

Dostupné s:

Gedeon Richter PLC

ATC kód:

M03AC06

INN (Mezinárodní Name):

pipecuronium bromide

Dávkování:

4mg

Léková forma:

powder lyophilized and solvent for solution for injection

Jednotky v balení:

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

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2020-05-18

Charakteristika produktu

2008-07-10
RGD: 70160/EN/1
RGD: 24962/HU/1
SUMMARY OF PRODUCT CHARACTERISTICS
for
ARDUAN 4 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
ARDUAN 4 MG LYOPHILIZED 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.
PHARMACEUTICAL FORM
Lyophilized powder for solution for injection.
White, almost white lyophilizate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Muscle
relaxation
on
a
background
of
general
anaesthesia
to
facilitate
endotracheal
intubation and surgical interventions 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.
Adults

initial doses of Arduan for intubation and subsequent surgery
Recommended doses: 0.06-0.08 mg/kg body weight.
With these doses good to excellent intubation conditions develop
within 150-180 seconds
and muscle relaxation lasts for approximately 60-90 minutes.
2/8

initial doses of Arduan for surgery following intubation with
succinylcholine
Recommended doses: 0.05 mg/kg body weight.
With these doses skeletal muscle relaxation lasts for 30-60 minutes.

doses of Arduan for the maintenance of muscle relaxation
Recommended doses: 0.01-0.02 mg/kg body weight.
These maintenance doses will prolong muscle relaxation, adequate for
surgery, for
approximately 30-60 minutes.

to patients with renal failure doses not higher than 0.04 mg/kg body
weight are
r