ESMOCARD 100 mg/10 ml solution for injection

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Esmolol Hydrochloride

Prieinama:

Orpha-Devel Handels und Vertriebs GmbH

ATC kodas:

C07AB; C07AB09

INN (Tarptautinis Pavadinimas):

Esmolol Hydrochloride

Dozė:

100 milligram(s)

Vaisto forma:

Solution for injection

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Gydymo sritis:

Beta blocking agents, selective; esmolol

Autorizacija statusas:

Not marketed

Leidimo data:

2008-03-07

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
ESMOCARD 100 MG/10 ML SOLUTION FOR INJECTION
Esmolol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ESMOCARD 100 mg/10 ml solution for injection is and what it is
used for
2.
What you need to know before you use ESMOCARD 100 mg/10 ml solution
for injection
3.
How to use ESMOCARD 100 mg/10 ml solution for injection
4.
Possible side effects
5.
How to store ESMOCARD 100 mg/10 ml solution for injection
6.
Contents of the pack and other information
1.
WHAT ESMOCARD 100 MG/10 ML SOLUTION FOR INJECTION IS AND WHAT IT IS
USED FOR
ESMOCARD 100 mg/10 ml belongs to the group of beta blockers. These
medicines slow down the
heartbeat and reduce blood pressure.
ESMOCARD 100 mg/10 ml is used for short-term treatment if your heart
beats too fast.
ESMOCARD 100 mg/10 ml is also used during or straight after surgery if
your blood pressure gets
too high and/or your heart beats too fast.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
ESMOCARD 100 MG/10 ML SOLUTION FOR INJECTION
YOUR DOCTOR WILL NOT GIVE YOU ESMOCARD 100 MG/10 ML IF:
-
You are allergic to esmolol hydrochloride. The signs of an allergic
reaction include shortness of
breath, wheezing, rash, itching or swelling of your face and lips
-
You have a very slow heart beat (less than 50 beats per minute)
-
You have a fast or alternating fast and slow heartbeat
-
You have something called “severe heart block”. Heart block is a
problem with the electrical
messages that control your heartbeat
-
You have low blood pressure
-
You have a pr

Prekės savybės

Health Products Regulatory Authority
06 October 2020
CRN009Z86
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ESMOCARD 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).
Excipients: This medicinal product contains approximately 0.34 mmol
(or 7.88 mg) of sodium per vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
The solution is clear and colourless.
The solution has a pH between 4.5 to 5.5 and osmolarity of
approximately 140 mOsm/l.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ESMOCARD 100 mg/10 ml is indicated for supraventricular tachycardia
(except for pre-excitation syndromes) and for the rapid
control of the ventricular rate in 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.
ESMOCARD 100 mg/10 ml is also indicated for tachycardia and
hypertension occuring in the perioperative phase and non-
compensatory sinus tachycardia where, in the physician’s judgement
the rapid heart rate requires specific intervention.
ESMOCARD 100 mg/10 ml is not indicated for use in children aged up to
18 years (see section 4.2).
ESMOCARD 100 mg/10 ml is not intended for use in chronic settings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ESMOCARD 100 mg/10 ml solution for injection in a vial with 10 ml is a
clear solution ready for intravenous use. The
concentration of this product is 10 mg/ml esmolol hydrochloride.
SUPRAVENTRICULAR TACHYARRHYTHMIA
The dosage of ESMOCARD 100 mg/10 ml should be titrated individually. A
starting dose is required, followed by a
maintenance dosage.
The effective dose of ESMOCARD 100 mg/10 ml is within the range of 50
to 200 micrograms/kg/min, although doses as high
as 300 micrograms /kg/min