ADENOSINE INJECTION, USP SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ADENOSINE

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

C01EB10

SNN (starptautisko nepatentēto nosaukumu):

ADENOSINE

Deva:

3MG

Zāļu forma:

SOLUTION

Kompozīcija:

ADENOSINE 3MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

2ML

Receptes veids:

Prescription

Ārstniecības joma:

CLASS IV ANTIARRYTHMICS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2017-05-09

Produkta apraksts

PRODUCT MONOGRAPH
PR
ADENOSINE INJECTION, USP
(adenosine injection, USP, 3mg/mL)
Sterile
6 mg / 2 mL Prefilled Syringe
ANTIARRHYTHMIC
Mylan Pharmaceuticals ULC
Date of Preparation: July 16, 2014
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No: 175322
2
PRODUCT MONOGRAPH
PR
ADENOSINE INJECTION, USP
(adenosine injection, USP, 3 mg/mL)
6 mg / 2mL Prefilled Syringe
THERAPEUTIC CLASSIFICATION
Antiarrhythmic
PART I: HEALTH PROFESSIONAL INFORMATION
ACTION AND CLINICAL PHARMACOLOGY
Adenosine Injection 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.
Adenosine Injection is not effective in converting rhythms other than
PSVT, such as
atrial flutter, atrial fibrillation, or ventricular tachycardia to
normal sinus rhythm.
Hemodynamics
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 Adenosine Inje