SIMDAX 2.5 MGML

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

LEVOSIMENDAN

MAH:

BIO-MED - J.R LTD, ISRAEL

ATC_code:

C01CX08

pharmaceutical_form:

CONCENTRATE FOR SOLUTION FOR INFUSION

composition:

LEVOSIMENDAN 2.5 MG/ML

administration_route:

I.V

prescription_type:

Required

manufactured_by:

ORION CORPORATION ORION PHARMA,FINLAND

therapeutic_group:

LEVOSIMENDAN

therapeutic_area:

LEVOSIMENDAN

therapeutic_indication:

Therapeutic indications: Short-term treatment of acutely decompensated severe chronic heart failure.Simdax should only be used as add-on therapy in situations where conventional therapy with e.g. diuretics, ACE-inhibitors and digitalis is not sufficient and where there is a need for inotropic support.

authorization_date:

2013-12-31

SPC

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Simdax 2.5 mg/ml.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each ml of concentrate
_ _
for solution for infusion 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
P
HARMACEUTICAL
F
ORM
Concentrate for solution for infusion.
The concentrate is a clear yellow or orange solution for dilution
prior to administration.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Simdax is indicated for the short-term
_ _
treatment of acutely decompensated severe chronic
heart failure (ADHF). Simdax should only be used as add-on therapy in
situations where
conventional therapy with e.g. diuretics, ACE-inhibitors and digitalis
_ _
is not sufficient, where
there is a need for inotropic support (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 o