ESMOCARD LYO 2500 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esmolol Hydrochloride

Available from:

Orpha-Devel Handels und Vertriebs GmbH

ATC code:

C07AB; C07AB09

INN (International Name):

Esmolol Hydrochloride

Dosage:

2500 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Beta blocking agents, selective; esmolol

Authorization status:

Not marketed

Authorization date:

2011-02-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESMOCARD LYO 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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 or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ESMOCARD LYO is and what it is used for
2.
What you need to know before you use ESMOCARD LYO
3.
How to use ESMOCARD LYO
4.
Possible side effects
5.
How to store ESMOCARD LYO
6.
Contents of the pack and other information
1. WHAT ESMOCARD LYO IS AND WHAT IT IS USED FOR
ESMOCARD LYO belongs to the group of beta blockers. These medicines
slow down the heart beat
and reduce blood pressure.
ESMOCARD LYO is used for short term treatment if your heart beats too
fast.
ESMOCARD LYO 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 LYO
YOUR DOCTOR WILL NOT GIVE YOU ESMOCARD LYO 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 problem with the blood supply to your heart
-
You are receiving or have recently received verapamil. You must not be
given ESMOCARD LYO
within 48 hours of when you stop receiving verapamil
-
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Summary of Product characteristics

Health Products Regulatory Authority
06 October 2020
CRN009Z86
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ESMOCARD LYO 2500 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A vial of 50 ml contains 2500 mg esmolol hydrochloride.
Each ml of reconstituted concentrate for solution for infusion
contains 50 mg esmolol hydrochloride (50 mg/ml).
Each ml of the diluted solution for infusion contains 10 mg esmolol
hydrochloride (10 mg/ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
The powder is white to almost white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ESMOCARD LYO is indicated for supraventricular tachycardia (except for
pre-excitation syndromes), and for the rapid control of
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 LYO is also indicated for tachycardia and hypertension
occurring in the perioperative phase and
non-compensatory sinus tachycardia where, in physician’s judgement
the rapid heart rate requires specific intervention.
ESMOCARD LYOis not indicated for use in children aged up to 18 years
(see section 4.2).
ESMOCARD LYO is not intended for use in chronic settings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ESMOCARD LYO 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MUST NOT BE ADMINISTERED WITHOUT
RECONSTITUTION/DILUTION.
The reconstituted/diluted solution for infusion must be used
immediately after opening (see sections 4.4 and 6).
The administration of incorrect reconstituted/diluted ESMOCARD LYO may
result in death (see section 4.4).
POSOLOGY
SUPRAVENTRICULAR TACHYARRHYTHMIA
The dosage of ESMOCARD LYO should be titrated individually. A starting
dose is required, followed by a maintenance dosage.
The effective dose of ESMOCARD LYO is within the r