Milrinone Generic Health

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Milrinone 1 mg/mL

Disponible desde:

Max Health Limited

Designación común internacional (DCI):

Milrinone 1 mg/mL

Dosis:

1 mg/mL

formulario farmacéutico:

Concentrate for injection

Composición:

Active: Milrinone 1 mg/mL Excipient: Glucose Lactic acid Sodium hydroxide Water for injection

tipo de receta:

Prescription

Fabricado por:

Erregierre SpA

indicaciones terapéuticas:

Milrinone is indicated for the short term intravenous therapy of severe congestive heart failure. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. Also indicated for low output states following cardiac surgery, including weaning from cardio-pulmonary bypass pump.

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, Type I, 10 mL capacity, packed into cardboard containers - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 72 hours diluted stored at or below 25°C

Fecha de autorización:

2015-02-16

Ficha técnica

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DATA SHEET
1
NAME OF MEDICINE
Milrinone Generic Health, 1 mg/mL injection concentrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sterile, single-dose ampoule contains 1 mg/mL milrinone (as
lactate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Injection concentrate.
Clear, colourless to pale yellow solution, practically free from
visible particles.
The pH is between 3.2 and 4.0.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Milrinone is indicated for the short term intravenous therapy of
severe congestive heart failure.
The majority of experience with intravenous milrinone has been in
patients receiving digoxin and
diuretics.
Milrinone is also indicated for low output states following cardiac
surgery, including weaning
from cardio-pulmonary bypass pump.
4.2
DOSE AND METHOD OF ADMINISTRATION
Milrinone should be administered with a loading dose followed by a
continuous infusion
(maintenance dose) according to the following guidelines:
LOADING DOSE
50 mcg/kg administered slowly over 10 minutes
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MAINTENANCE DOSE
TABLE 1
INFUSION RATE
TOTAL DAILY DOSE
(24 HOURS)
MINIMUM
0.375 mcg/kg/min
0.60 mg/kg
STANDARD
0.50 mcg/kg/min
0.77 mg/kg
MAXIMUM
0.75 mcg/kg/min
1.13 mg/kg
Note: Administer as a continuous intravenous infusion.
The infusion rate should be adjusted according to haemodynamic and
clinical response. Patients
should be closely monitored. Most patients show an improvement in
haemodynamic status as
evidenced by increases in cardiac output and reductions in pulmonary
capillary wedge pressure.
Note: See "Dosage Adjustment in Renally Impaired Patients".
Dosage may be titrated to the maximum haemodynamic effect and should
not exceed
1.13 mg/kg/day. Duration of therapy should depend upon patient
responsiveness.
Intravenous infusions of milrinone should be administered as described
in Table 2.
TABLE 2 • MILRINONE - RATES OF INFUSION FOR CONCENTRATIONS OF 100
MCG/ML, 150 MCG/ML AND 200
MCG/ML. INFUSION DELIVERY RATE MILRINONE
(MCG/KG/MIN)
100 MCG/ML
(ML/KG/HR)