Brevibloc Premixed 10 mg/ml Solution for Injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

ESMOLOL HYDROCHLORIDE

Saatavilla:

Baxter Healthcare Limited

ATC-koodi:

C07AB; C07AB09

INN (Kansainvälinen yleisnimi):

ESMOLOL HYDROCHLORIDE

Annos:

10 milligram(s)/millilitre

Lääkemuoto:

Solution for injection

Prescription tyyppi:

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

Terapeuttinen alue:

Beta blocking agents, selective; esmolol

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2010-12-10

Pakkausseloste

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Package leaflet: Information for the patient
BREVIBLOC Premixed 10 mg/ml Solution for
Injection
Esmolol hydrochloride
Read all of this leaflet carefully before you are given this
medicine. 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, nurse or
pharmacist
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet.
Throughout this leaflet, BREVIBLOC Premixed 10 mg/ml Solution for
Injection
will be called Brevibloc.
What is in this leaflet:
1.
What Brevibloc is and what it is used for
2.
What you need to know before you are given Brevibloc
3.
How you will be given Brevibloc
4.
Possible side effects
5.
How to store Brevibloc
6.
Contents of the pack and other information
1.
What Brevibloc is and what it is used for
Brevibloc contains a medicine called esmolol. It belongs to a group of
medicines called ‘beta-blockers’. It works by controlling the rate
and force of
your heartbeat. It can also help to reduce your blood pressure.
It is used to treat:
•
Heartbeat problems, when your heart beats too fast
•
Heartbeat problems and an increase in your blood pressure if this
happens during or straight after an operation.
2. What you need to know before you are given
Brevibloc
Your doctor will not give you Brevibloc if:
•
You are allergic (hypersensitive) to esmolol, to other beta-blocker
medicines, or any of the other ingredients of this medicine (listed in
section
6).
The signs of an allergic reaction include

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brevibloc Premixed 10 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Brevibloc Premixed 10 mg/ml Solution for Injection contains 10 mg of
esmolol hydrochloride per ml.
Each vial of
10 ml contains 100 mg of esmolol hydrochloride.
Excipients:
This medicinal product contains approximately 1.22 mmol (or 28 mg) of
sodium per vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless to light yellow solution.
The solution has a pH between 4.5 to 5.5 and osmolarity of
approximately 300 mOsm/l.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Supraventricular tachycardia (except for pre-excitation syndromes) or
non-compensatory sinus tachycardia
Brevibloc is indicated 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.
Brevibloc is also indicated for non-compensatory sinus tachycardia
where, in the physician’s judgement the rapid heart
rate requires specific intervention.
Tachycardia and hypertension occurring in the perioperative phase
Treatment
of tachycardia and hypertension that
occur during induction of anesthesia and tracheal
intubation,
during
surgery, on emergence from anesthesia, and in the postoperative
period, when in the physician’s judgment such specific
intervention is considered indicated.
Brevibloc is not indicated for use in children aged up to 18 years
(see section 4.2). Brevibloc is not intended for use in
chronic settings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Brevibloc Premixed 10 mg/ml Solution for Injection is a ready-to-use
10 mg/ml solution recommended for intravenous
administration.
This dosage form is used to administer the appropriate Brevibloc
loading dose or bolus dose by hand held syringe.
SUPRAVENTRICULAR
TACHYARRYTHMIA
(EXCEPT
FOR
PRE-