Brevibloc Premixed 10 mg/ml Solution for Infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

ESMOLOL HYDROCHLORIDE

Prieinama:

Baxter Healthcare Limited

ATC kodas:

C07AB; C07AB09

INN (Tarptautinis Pavadinimas):

ESMOLOL HYDROCHLORIDE

Dozė:

10 milligram(s)/millilitre

Vaisto forma:

Solution for infusion

Recepto tipas:

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

Gydymo sritis:

Beta blocking agents, selective; esmolol

Autorizacija statusas:

Marketed

Leidimo data:

2010-12-10

Pakuotės lapelis

EUROPEAN LABELLING CENTRE
ARTWORK APPROVAL
3rd DRAFT
DATE 14 May 2015
RA
PROOFREAD + APPROVED
MARKETING
APPROVED
Country
Name
Signature
Date
BE-30-01-984
Package leaflet:
Information for the patient
BREVIBLOC Premixed 10 mg/ml
Solution for Infusion
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 Infusion 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 shortness of breath, wheezing,
rash, itching or swelling of your face and lips
•
You have a very slow heartbeat (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

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brevibloc Premixed 10 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Brevibloc Premixed 10 mg/ml Solution for Infusion contains 10 mg of
esmolol hydrochloride per ml.
Each bag of 250
ml contains 2500 mg of esmolol hydrochloride.
Excipients:
This medicinal product contains approximately 30.45 mmol (or 700 mg)
of sodium per bag.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
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 judgment 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 Infusion is a ready-to-use 10
mg/ml iso-osmotic solution, recommended for
intravenous administration.
SUPRAVENTRICULAR TACHYARRYTHMIA (EXCEPT FOR PRE-EXCITATION SYNDROMES)
OR NON-
COMPENSATORY SINUS TACHYCARDIA
The Brevibloc dosage in supraventricular tachyarrhyt