ESMOLOL AMOMED 100 MG10 ML

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

ESMOLOL HYDROCHLORIDE

Disponible des:

AOP ORPHAN PHARMACEUTICALS ISRAEL LTD, ISRAEL

Codi ATC:

C07AB09

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

ESMOLOL HYDROCHLORIDE 10 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

AOP ORPHAN PHARMACEUTICALS GMBH, AUSTRIA

Área terapéutica:

ESMOLOL

indicaciones terapéuticas:

Esmolol Amomed 100 mg/10 ml is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in adult patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short-acting agent is desirable.Esmolol Amomed 100 mg/10 ml is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia in adult patients where, in the physician’s judgement the rapid heart rate requires specific intervention.Esmolol Amomed 100 mg/10 ml is not intended for use in chronic settings.

Data d'autorització:

2022-04-30

Fitxa tècnica

1
NAME OF THE MEDICINAL PRODUCT
Esmolol Amomed 100 mg/10 ml
solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 10 ml solution for injection contains 100 mg
Esmolol hydrochloride.
1 ml aqueous solution contains 10 mg Esmolol hydrochloride
(10 mg/ml).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Esmolol Amomed 100 mg/10 ml is indicated for
supraventricular tachycardia (except for pre-excitation
syndromes) and for the rapid
control of the ventricular rate in
adult patients with atrial fibrillation or atrial flutter in
perioperative, postoperative, or other circumstances
where short-term control of the ventricular rate with a short-acting
agent is desirable.
Esmolol Amomed 100 mg/10 ml is also indicated for
tachycardia and hypertension occuring in the perioperative
phase and non-
compensatory sinus tachycardia in adult
patients where, in the physician’s judgement the rapid heart
rate requires specific intervention.
Esmolol Amomed 100 mg/10 ml is not intended for use in
chronic settings.
4.2
Posology and method of administration
Esmolol Amomed 100 mg/10 ml solution for injection is
a clear solution ready for intravenous use. The concentration of this
product is 10
mg/ml Esmolol hydrochloride.
SUPRAVENTRICULAR
TACHYARRHYTHMIA
The dosage of Esmolol should be titrated individually. A starting dose
is required, followed by a maintenance
dosage.
The effective dose of Esmolol hydrochloride is within the
range of 50 to 200 micrograms/kg/min, although doses as
high as 300
micrograms/kg/min have been used. In a few
patients the average effective dosage of 25 micrograms/
kg/min has been adequate.
As the desired heart rate or safety endpoint (e.g. lowered
blood pressure) is approached, OMIT the loading infusion and
reduce the
incremental dose in the maintenance infusion from 50 micrograms/kg/min
to 25 micrograms/kg/min or
lower.
If necessary, the interval betwee