BREVIBLOC Esmolol hydrochloride 100mg/10mL injection

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

esmolol hydrochloride, Quantity: 100 mg

Disponível em:

Phebra Pty Ltd

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: water for injections; hydrochloric acid; sodium acetate trihydrate; glacial acetic acid

Via de administração:

Intravenous

Unidades em pacote:

20 x 10mL vial, 5 x 10mL vial

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Supraventricular Tachycardia - for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. Esmolol is not intended for use in chronic settings where transfer to another agent is anticipated, or for treatment periods greater than 24 hours duration.

Resumo do produto:

Visual Identification: A clear, colourless to slight straw coloured solution free of visible particulate matter.; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

1993-03-04

Folheto informativo - Bula

Brevibloc esmolol hydrochloride 100mg/10mL Injection Vial
Page 1 of 3
BREVIBLOC
® INJECTION
CONTAINS ESMOLOL HYDROCHLORIDE 100 MG IN 10 ML
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about Brevibloc Injection. It
does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given Brevibloc Injection
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BREVIBLOC
INJECTION IS USED FOR
Brevibloc Injection is used as a short-
term treatment for irregular heartbeat
before, during or after surgery. It is
also used in emergency situations.
Irregular heartbeat, also known as
arrhythmia, means that there is a
disturbance of the heart's normal
rhythm or beat. Arrhythmia may be
caused by a number of factors,
including some heart diseases, an
overactive thyroid gland, or chemical
imbalances. Brevibloc Injection helps
restore the heart's normal rhythm.
Brevibloc Injection belongs to a group
of medicines called beta-blockers.
_ _
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BREVIBLOC
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it for
another reason.
_ _
This medicine is available only with a
doctor’s prescription.
There is not enough information to
recommend the use of Brevibloc
Injection in children.
BEFORE YOU ARE GIVEN
BREVIBLOC INJECTION
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT_
YOU SHOULD NOT BE GIVEN BREVIBLOC
INJECTION IF YOU HAVE AN ALLERGY TO:_ _

any medicine containing
esmolol
hydrochloride

any of the ingredients listed at the
end of this leaflet

any other beta-blocker medicines.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face lips tongue or
other parts of the body


Características técnicas

PRODUCT INFORMATION
Australian Product Information – Brevibloc
Page 1 of 17
Version 02.1 BREVIBLOC
®
(ESMOLOL HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Esmolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Brevibloc Injection is supplied as 100 mg/10 mL vial.
Brevibloc Powder for Injection is supplied in a 50 mL vial containing
2.5 g esmolol hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
100 MG/ 10 ML VIAL:
Brevibloc Injection is a clear, colourless to light yellow, sterile,
nonpyrogenic solution for intravenous infusion. The
single dose vial has a pH range of 4.5 to 5.5.
2.5 G VIAL:
Powder for concentrate for solution for infusion.
Esmolol hydrochloride powder is a white to almost white powder.
The reconstituted solution is a clear and colourless liquid free from
visible particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SUPRAVENTRICULAR TACHYCARDIA
Brevibloc is indicated for the rapid control of ventricular rate in
patients with atrial fibrillation or atrial flutter in
perioperative, postoperative, or other emergent circumstances where
short term control of ventricular rate with a
short-acting agent is desirable. Brevibloc is also indicated in non
compensatory sinus tachycardia where, in the
physician's judgement, the rapid heart rate requires specific
intervention. Brevibloc is not intended for use in chronic
settings where transfer to another agent is anticipated or for
treatment periods greater than 24 hours duration.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Note:_ Parenteral drug products should be inspected visually prior to
administration. Any solutions which contain
visible particulate matter or are hazy or discoloured should not be
used. Product is for single use in one patient
only. Discard any residue.
PRODUCT INFORMATION
BREVIBLOC
Australian Product Information – Brevibloc
Page 2 of 17
Version 02.1
100 MG/ 10 ML VIAL:
This dosage form is prediluted to provide a ready-to-use 10 mg/mL
concentration recommended for Brevibl