PRIMACOR INJECTION 1mgml

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Milrinone Lactate 1.427mg eqv Milrinone 1.00mg

זמין מ:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

קוד ATC:

C01CE02

כמות:

1mg

טופס פרצבטיות:

INJECTION

הרכב:

Milrinone Lactate 1.427mg eqv Milrinone 1.00mg 1mg

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

DELPHARM DIJON

מצב אישור:

ACTIVE

תאריך אישור:

1994-02-02

עלון מידע

 
Primacor® 

_Milrinone lactate _

Injection                                     

     [Sanofi-Aventis Logo] 

DESCRIPTION 
PRIMACOR, brand of milrinone lactate injection, is a member of a
new class of  bipyridine 
inotropic/vasodilator agents with
phosphodiesterase inhibitor activity,  distinct from digitalis 
glycosides or catecholamines. PRIMACOR (milrinone  lactate) is designated chemically as 
1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and
has the  following 
structure: 

Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and an 
empirical formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in 
chloroform and in water. As the lactate salt, it
is stable and colorless to pale yellow in solution. 
PRIMACOR is available as sterile aqueous solutions  of the
lactate salt of milrinone for 
injection or infusion intravenously. 
Sterile, single-dose ampoule: Single-dose ampoules of 10, 20 and 50 mL contain in each mL 
milrinone  lactate equivalent to 1 mg milrinone and 47 mg
Dextrose, Anhydrous, USP, in 
Water for Injection, USP. The pH is adjusted to between 3.2
and 4.0 with lactic acid or sodium 
hydroxide. The total concentration of lactic acid can
vary between 0.95 mg/mL and  1.29 
mg/mL. These ampoules  require
preparation of dilutions prior to administration to  patients 
intravenously. 
Pre-Mix Flexible Containers:
The nominal concentration of lactic acid is 0.282 mg/mL. Each mL
also contains 49.4  mg 
Dextrose, Anhydrous, USP. The pH is adjusted to between 3.2 and
4.0 with lactic  acid or 
sodium hydroxide. The flexible plastic container is comprised of polyvinyl  chloride with a foil 
overwrap. Water can perme

מאפייני מוצר

DESCRIPTION
PRIMACOR, brand of milrinone lactate injection, is a member of a new
class of bipyridine inotropic/
vasodilator agents with phosphodiesterase inhibitor activity, distinct
from digitalis glycosides or
catecholamines. PRIMACOR (milrinone lactate) is designated chemically
as 1,6-dihydro-2-methyl-
6-oxo-[3,4’-bipyridine]-5-carbonitrile lactate and has the following
structure:
Milrinone is an off-white to tan crystalline compound with a molecular
weight of 211.2 and an
empirical formula of C12H9N3O. It is slightly soluble in methanol, and
very slightly soluble in
chloroform and in water. As the lactate salt, it is stable and
colorless to pale yellow in solution.
PRIMACOR is available as sterile aqueous solutions of the lactate salt
of milrinone for injection or
infusion intravenously.
Sterile, single-dose ampoule: Single-dose ampoules of 10, 20 and 50 mL
contain in each mL
milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose,
Anhydrous, USP, in Water for
Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic
acid or sodium hydroxide. The
total concentration of lactic acid can vary between 0.95 mg/mL and
1.29 mg/mL. These ampoules
require preparation of dilutions prior to administration to patients
intravenously.
Pre-Mix Flexible Containers: The Flexible Containers provide two
ready-to use dilutions of
milrinone in volumes of 100 mL and 200 mL of 5% Dextrose Injection.
Each mL contains milrinone
lactate equivalent to 200 mcg milrinone.
The nominal concentration of lactic acid is 0.282 mg/mL. Each mL also
contains 49.4 mg Dextrose,
Anhydrous, USP. The pH is adjusted to between 3.2 and 4.0 with lactic
acid or sodium hydroxide.
The flexible plastic container is comprised of polyvinyl chloride with
a foil overwrap. Water can
permeate the plastic into the overwrap, but the amount is insufficient
to significantly affect the
pre-mix solution.
CLINICAL PHARMACOLOGY
PRIMACOR is a positive inotrope and vasodilator, with little
chronotropic activity different in
structure and mode of acti