BREVIBLOC esmolol hydrochloride 2.5 g powder for injection for infusion vial

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

esmolol hydrochloride, Quantity: 2500 mg

থেকে পাওয়া:

Phebra Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, powder for

রচনা:

Excipient Ingredients:

প্রশাসন রুট:

Intravenous Infusion

প্যাকেজ ইউনিট:

Pack of 1

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Supraventricular tachycardia,Brevibloc (esmolol HCl) 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.

পণ্য সারাংশ:

Visual Identification: White to almost white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2020-01-21

তথ্য লিফলেট

Brevibloc esmolol hydrochloride 2500mg powder for Injection Vial
Page 1 of 3
BREVIBLOC
® POWDER FOR INJECTION
CONTAINS ESMOLOL HYDROCHLORIDE 2500MG PER VIAL
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about Brevibloc Powder for
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 Powder for
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 POWDER
FOR INJECTION IS USED FOR
Brevibloc Powder for 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 Powder for
Injection helps restore the heart's
normal rhythm.
Brevibloc Powder for Injection belongs
to a group of medicines called beta-
blockers.
_ _
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BREVIBLOC
POWDER FOR 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
Powder for Injection in children.
BEFORE YOU ARE GIVEN
BREVIBLOC POWDER FOR
INJECTION
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT_
YOU SHOULD NOT BE GIVEN BREVIBLOC
POWDER FOR 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:

পণ্য বৈশিষ্ট্য

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