Simdax concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levosimendan

Available from:

Orion Corporation

ATC code:

C01CX08

INN (International Name):

levosimendan

Dosage:

2,5mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

glass vial 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-10-24

Summary of Product characteristics

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Simdax 2.5 mg/ml concentrate for solution for infusion.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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
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) 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.