国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
esmolol hydrochloride, Quantity: 100 mg
Phebra Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium acetate trihydrate; glacial acetic acid
Intravenous
20 x 10mL vial, 5 x 10mL vial
(S4) Prescription Only Medicine
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.
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
Registered
1993-03-04
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 完全なドキュメントを読む
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 完全なドキュメントを読む