Simdax 2.5 mgml concentrate for solution for infusion.

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Levosimendan

זמין מ:

ORION PHARMA (MY) SDN. BHD.

INN (שם בינלאומי):

Levosimendan

יחידות באריזה:

1 Vials; 4 Vials; 10 Vials

תוצרת:

ORION CORPORATION, ORION PHARMA

מאפייני מוצר

PACKAGE INSERT
1
NAME OF THE MEDICINAL PRODUCT
Simdax 2.5 mg/ml concentrate for solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 2.5 mg of levosimendan. One 5 ml vial
contains 12.5 mg of
levosimendan.
Excipient with known effect: Ethanol.
This medicinal product contains 785 mg/ml ethanol (alcohol). For a
full list of excipients, see
section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The concentrate is a clear yellow or orange solution for dilution
prior to administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Simdax is indicated for the short-term treatment of acutely
decompensated severe chronic heart
failure (ADHF) in situations where conventional therapy is not
sufficient, and in cases where
inotropic support is considered appropriate (see section 5.1.).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Simdax is for in-hospital use only. It should be administered in a
hospital setting where adequate
monitoring facilities and expertise with the use of inotropic agents
are available.
_Posology_
The dose and duration of treatment should be individualised according
to the patient's clinical
condition and response.
The treatment should be initiated with a loading dose of 6-12
microgram/kg infused over
10 minutes followed by a continuous infusion of 0.1 microgram/kg/min
(see section 5.1).
The lower loading dose of 6 microgram/kg is recommended for patients
on concomitant
intravenous vasodilators or inotropes or both at the start of the
infusion. Higher loading doses
within this range will produce a stronger haemodynamic response but
may be associated with
a transient increased incidence of adverse reactions. The response of
the patient should be
assessed with the loading dose or within 30 to 60 minutes of dose
adjustment and as clinically
indicated. If the response is deemed excessive (hypotension,
tachycardia), the rate of the infusion
may be decreased to 0.05 microgram/kg/min or discontinued (see section
4.4). If the initial dose
is tole