AJ-ADENOSINE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ADENOSINE

Tersedia dari:

AGILA JAMP CANADA INC

Kode ATC:

C01EB10

INN (Nama Internasional):

ADENOSINE

Dosis:

3MG

Bentuk farmasi:

SOLUTION

Komposisi:

ADENOSINE 3MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

CLASS IV ANTIARRYTHMICS

Ringkasan produk:

Active ingredient group (AIG) number: 0113219001; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2015-11-03

Karakteristik produk

PRODUCT MONOGRAPH
PR
AJ-ADENOSINE
Adenosine Injection, USP
3 mg / mL
Sterile
6 mg / 2 mL Vial
&
6 mg / 2 mL Prefilled Syringe
ANTIARRHYTHMIC
AGILA JAMP CANADA INC.
DATE OF PREPARATION:
1380 – 203 Newton
August 15, 2013
Boucherville, Québec
Canada, J4B 5H2
CONTROL NO.: 166794
2
PRODUCT MONOGRAPH
PR
AJ-ADENOSINE
Adenosine Injection, USP
3 mg / mL
6 mg / 2 mL Vial
6 mg / 2 mL Prefilled Syringe
THERAPEUTIC CLASSIFICATION
Antiarrhythmic
PART I: HEALTH PROFESSIONAL INFORMATION
ACTION AND CLINICAL PHARMACOLOGY
AJ-ADENOSINE is an endogenous nucleoside occurring in all cells of the
body. When
injected intravenously adenosine slows atrioventricular (A-V) nodal
conduction, can
interrupt the reentry pathways through the A-V node and can restore
normal sinus rhythm
in
patients
with
paroxysmal
supraventricular
tachycardia
(PSVT),
including
PSVT
associated with Wolff-Parkinson-White syndrome.
Adenosine
is
antagonized
competitively
by
methylxanthines
such
as
caffeine
and
theophylline and potentiated by blockers of nucleoside transport such
as dipyridamole.
Adenosine is not blocked by atropine.
In controlled clinical trials, cumulative 60% and 92% of patients
converted to normal
sinus rhythm within one minute after 6 mg and 12 mg bolus doses of
adenosine injection,
respectively. In other controlled clinical trials with bolus doses of
3, 6, 9 and 12 mg some
patients with paroxysmal supraventricular tachycardia converted to
normal sinus rhythm
on 3 mg of adenosine injection. Reports in the medical literature
indicate success in
treating PSVT in pediatric patients (including newborns) with
adenosine injection in
doses equivalent by weight to those used in adults.
AJ-ADENOSINE is not effective in converting rhythms other than PSVT,
such as atrial
flutter, atrial fibrillation, or ventricular tachycardia to normal
sinus rhythm.
Hemodynamics
3
Adenosine is a potent vasodilator in most vascular beds, except in
renal afferent arterioles
and hepatic veins where it produces vasoconstriction. The intravenous
bolus dose of 6 or
12 mg AJ-AD