BREVIBLOC esmolol hydrochloride 2.5g/10mL injection

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

esmolol hydrochloride, Quantity: 250 mg/mL

Sẵn có từ:

Phebra Pty Ltd

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: propylene glycol; ethanol; water for injections; hydrochloric acid; sodium hydroxide; sodium acetate; glacial acetic acid

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

4x10mL ampoule (shrink wrap), 1x10mL ampoule

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Visual Identification: A clear colourless to slight straw coloured solution free of visible particulate matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1993-03-04

Đặc tính sản phẩm

PRODUCT INFORMATION
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_BREVIBLOC_
_®_
_ INJECTION _
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Product Information Brevibloc Injection
Page 1
_Version 02 _
BREVIBLOC
® INJECTION
NAME OF THE MEDICINE
Esmolol hydrochloride
Esmolol HCl ± methyl 3-[4-[2-hydroxy-3-(isopropylamino) propoxy]
phenyl] propionate hydrochloride.
Esmolol HCl has the empirical formula C
16
H
25
NO
4
.HCl and a molecular weight of 331.8. The CAS registry number
is 81161-17-3. It has one asymmetric centre and exists as a racemic
mixture.
_ _
_Structural Formula: _
_ _
_ _
_ _
DESCRIPTION
Brevibloc (esmolol HCl) is a beta
1
-selective (cardioselective) adrenergic receptor blocking agent with a
very short
duration of action (elimination half-life is approximately 9 minutes).
Esmolol HCl is a white to off-white crystalline powder. It is a
relatively hydrophilic compound which is very soluble
in water and freely soluble in alcohol. Its partition coefficient
(octanol/water) at pH 7.0 is 0.42 compared to 17.0 for
propranolol.
Brevibloc (esmolol HCl) Injection is a clear, colourless to light
yellow, sterile, nonpyrogenic solution for intravenous
infusion. The ampoule has a pH range of 3.5 to 5.5. The single dose
vial has a pH range of 4.5 to 5.5.
Excipients in the 10mL vial are sodium acetate trihydrate, acetic
acid-glacial, hydrochloric acid and Water for
Injection.
Excipients in the 10mL ampoule are sodium acetate trihydrate,
propylene glycol, ethanol, acetic acid, sodium
hydroxide, hydrochloric acid, and Water for Injection.
PHARMACOLOGY
Brevibloc (esmolol HCl) is a beta
1
-selective (cardioselective) adrenergic blocking agent with rapid
onset and a
short duration of action.
MECHANISM OF ACTION
Brevibloc (esmolol HCl) is a beta
1
-selective (cardioselective) adrenergic receptor blocking agent with
rapid onset,
a very short duration of action and no significant intrinsic
sympathomimetic or membrane stabilising activity at
therapeutic dosages. Its elimination half-life afte