PRIMACOR INJECTION 1MGML

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MILRINONE

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

MILRINONE

Units in package:

10ml Ampoules

Manufactured by:

DELPHARM DIJON

Patient Information leaflet

Not applicable

Summary of Product characteristics

Primacor 1mg/ml Solution for Injection
Milrinone
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1mg/ml of the active substance Milrinone.
For excipients, see List of Excipients
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to pale yellow liquid.
CLINICAL PARTICULARS
Therapeutic indications
PRIMACOR is indicated for the short -term intravenous treatment of patients with
acute decompensated heart failure. Patients receiving PRIMACOR should be observed
closely wi th appropriate electrocardiographic equipment. The facility for immediate
treatment of potential cardiac events, which may include life threatening ventricular
arrythmias, must be available.The majority of experience with intravenous
PRIMACOR has been in p atients receiving digoxin and diuretics.
There is no experience in controlled trials with infusions of PRIMACOR for periods
exceeding 48 hours.
Posology and method of administration
PRIMACOR should be administered with a loading dose followed by a continuous
infusion (maintenance dose) according to the following guidelines:
LOADING DOSE
50 mcg/kg: Administer slowly over 10 minutes
The table below shows the loading dose in milliliters (mL) of PRIMACOR (1mg/mL) by
patient body weight (kg).
Loading Dos e (mL) Using 1 mg/mL Concentration
The loading dose may be given undiluted, but diluting to a rounded total volume of
10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the
injection rate.