PRIMACOR INJECTION 1MG/ML SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MILRINONE (MILRINONE LACTATE)

זמין מ:

SANOFI-SYNTHELABO CANADA INC

קוד ATC:

C01CE02

INN (שם בינלאומי):

MILRINONE

כמות:

1MG

טופס פרצבטיות:

SOLUTION

הרכב:

MILRINONE (MILRINONE LACTATE) 1MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10ML & 20ML

סוג מרשם:

Prescription

איזור תרפויטי:

CARDIOTONIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0131285001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2005-08-01

מאפייני מוצר

PRODUCT MONOGRAPH
PR
PRIMACOR
* INJECTION
(milrinone lactate injection)
10 mL and 20 mL vials (1 mg milrinone/mL)
100 mL Flexible Container (200
:
g/mL)
INOTROPE/VASODILATOR
Date of Preparation:
*
Trade Mark of Sanofi-Synthelabo, Inc.
Dec 11, 1996
Sanofi-Synthelabo Canada Inc.
Date of revision:
Markham, Ontario
January 16, 2004
Control #: 087235
-2-
PRODUCT MONOGRAPH
PR
PRIMACOR
* INJECTION
(milrinone lactate injection)
10 mL and 20 mL vials (1 mg milrinone/mL)
PHARMACOLOGICAL CLASSIFICATION
inotrope/vasodilator
ACTION AND CLINICAL PHARMACOLOGY
PRIMACOR (milrinone lactate) Injection is a positive inotrope and
vasodilator, with little
chronotropic activity, different in structure and mode of action from
either the digitalis
glycosides or catecholamines.
Milrinone, at relevant inotropic and vasorelaxant concentrations, is a
selective inhibitor of peak
III cAMP phosphodiesterase isozyme in cardiac and vascular muscle.
This inhibitory action is
consistent with cAMP mediated increases in intracellular ionized
calcium and contractile force in
cardiac muscle, as well as with cAMP dependent contractile protein
phosphorylation and
relaxation in vascular muscle. Additional experimental evidence also
indicates that it is not a
beta-adrenergic agonist, nor does it inhibit sodium-potassium
adenosine triphosphatase activity
as do the digitalis glycosides.
Clinical studies in patients with congestive heart failure have shown
that PRIMACOR Injection
produces dose and plasma level-related increase in left ventricular
dP/dt, increase in forearm
blood flow indicating a direct arterial vasodilator activity of the
drug, and improves diastolic
function as evidenced by improvement in left ventricular diastolic
relaxation.
-3-
Studies in normal subjects have shown that PRIMACOR Injection produces
increases in the
slope of the left ventricular pressure-dimension relationship,
indicating a direct inotropic effect
of the drug. Both the inotropic and vasodilatory effects have been
observed over the therapeutic
range of milrinone plasma conc