MILRINONE INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MILRINONE (MILRINONE LACTATE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

C01CE02

INN (Kansainvälinen yleisnimi):

MILRINONE

Annos:

1MG

Lääkemuoto:

SOLUTION

Koostumus:

MILRINONE (MILRINONE LACTATE) 1MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

10/20/50ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CARDIOTONIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2015-07-22

Valmisteyhteenveto

PRODUCT MONOGRAPH
MILRINONE INJECTION
(milrinone lactate injection)
1 mg/mL milrinone as lactate
10 mL, 20 mL and 50 mL vials
Inotrope/Vasodilator
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
May 28, 2014
Toronto, Ontario
M1B 2K9
CONTROL NO: 174105
-2-
PRODUCT MONOGRAPH
MILRINONE INJECTION
(milrinone lactate injection)
1 mg/mL milrinone as lactate
10 mL, 20 mL and 50 mL vials
THERAPEUTIC CLASSIFICATION
Inotrope/Vasodilator
ACTION AND CLINICAL PHARMACOLOGY
Milrinone Injection (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 decreases 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
-2-
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 milrinone 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.
Studies in normal subjects have shown that milrinone 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 concentrations of 100 to300 ng/mL.
PHARMACOKINETICS
Following intravenous loading inject