Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
amiodarone hydrochloride, Quantity: 150 mg
Sanofi-Aventis Australia Pty Ltd
Amiodarone hydrochloride
Injection, solution
Excipient Ingredients: polysorbate 80; benzyl alcohol; water for injections
Intravenous
10x3mL, 6x3mL ampoules
Medicine Registered
(S4) Prescription Only Medicine
Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome, supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation. Cordarone X intravenous may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. Cordarone X intravenous should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise
Visual Identification: Pale yellow clear solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-09-30
CORDARONE X ® _Amiodarone hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cordarone X tablets and injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. In deciding to give you Cordarone X, your doctor has weighed the risks of you taking Cordarone X against the benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT CORDARONE X IS USED FOR Cordarone X is used to control a fast or irregular heart beat. It works by lengthening the gap between one heart beat and the next, helping to bring the heart rate to a slower and more regular pace. Cordarone X is not recommended for use in children. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE IT _WHEN YOU MUST NOT USE_ _CORDARONE X_ 1. DO NOT USE CORDARONE X IF YOU ARE ALLERGIC TO AMIODARONE OR IODINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. The symptoms of an allergic reaction may include a rash, itching, swelling, coughing, an asthma attack or hayfever. 2. DO NOT USE CORDARONE X IF YOU ARE PREGNANT OR INTENDING TO GET PREGNANT. Cordarone X is best avoided in the 3 months before getting pregnant and during pregnancy. This is because it can stay in the body for several months even after you stop taking it. 3. DO NOT BREASTFEED IF YOU ARE USING CORDARONE X AS IT CAN BE FOUND IN BREAST MILK. If you are breastfeeding, alternative feeding arrangements such as bottle feeding should be made for your baby. TALK TO YOUR DOCTOR ABOUT THE RISKS AND BENEFITS OF TAKING CORDARONE X DURING PREGNANCY AND BREASTFEEDING. 4. DO NOT USE CORDARONE X IF YOU HAVE OR HAVE HAD ANY THYROID PROBLEMS. 5. DO NOT USE CORDARONE X Izlasiet visu dokumentu
cor-x-ccdsv21-piv19-25nov21 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION – CORDARONE X 100 ® , CORDARONE X 200 ® AND CORDARONE X INTRAVENOUS ® (AMIODARONE HYDROCHLORIDE) 1 NAME OF THE MEDICINE Amiodarone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of the Cordarone X range of products is amiodarone hydrochloride. Tablets Each 200 mg tablet of amiodarone contains approximately 75 mg organic iodine and in the steady state, metabolism of 300 mg amiodarone yields 9 mg/day of iodine. Injection Each ampoule contains 150 mg amiodarone hydrochloride in 3 mL. For the full list of excipients, see Section 6.1 List of excipients. Excipient with known effect: Tablets contain Lactose monohydrate 3 PHARMACEUTICAL FORM TABLETS Cordarone X 100 - white to off-white biconvex tablet embossed on one side with '100' and 'action potential' and scored on other. Cordarone X 200 - white to off-white biconvex tablet embossed with '200' and 'action potential' on one side and scored on the other. INJECTION Cordarone X Intravenous is a clear, pale yellow solution for intravenous administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome, supraventricular, nodal and ventricular tachyardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended cor-x-ccdsv21-piv19-25nov21 Page 2 of 27 that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest X-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation. Cordarone X Intravenous may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. Cordarone X Intravenous should only be used where facilities exist for cardiac monitoring and defibrill Izlasiet visu dokumentu