MILRINONE LACTATE INJECTION SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

MILRINONE (MILRINONE LACTATE)

Saadav alates:

STRIDES PHARMA CANADA INC

ATC kood:

C01CE02

INN (Rahvusvaheline Nimetus):

MILRINONE

Annus:

1MG

Ravimvorm:

SOLUTION

Koostis:

MILRINONE (MILRINONE LACTATE) 1MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

CARDIOTONIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2020-08-12

Toote omadused

PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION
(milrinone lactate injection)
SOLUTION FOR INTRAVENOUS USE
1 mg/mL milrinone (as milrinone lactate)
10 ML AND 20 ML VIALS
INOTROPE / VASODILATOR
Strides Pharma Canada Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 10, 2020
Varennes, Quebec
Canada, J3X 1P7
Submission Control No.: 241158
- 1 -
PRODUCT MONOGRAPH
Pr
Milrinone Lactate Injection
(milrinone lactate injection)
1 mg/mL milrinone (as milrinone lactate)
10 mL and 20 mL vials
THERAPEUTIC CLASSIFICATION
Inotrope / Vasodilator
ACTION AND CLINICAL PHARMACOLOGY
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 milrinone lactate 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.
Studies in normal subjects have shown that milrinone lactate injection
produces increases in the slope
of the left ventricular pressure-dimension relationship, indicating a
direct inotropic effect of
- 2 -
the drug. Both the inotropic and vasodilatory effects have been
observed over the therapeu