Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 0.5 mg
Dr Falk Pharma Australia Pty Ltd
Tablet, orally disintegrating
Excipient Ingredients: magnesium stearate; mannitol; macrogol 6000; sodium acid citrate; sodium dihydrogen citrate; sodium bicarbonate; sucralose; povidone; docusate sodium
Oral
100 tablets, 20 tablets, 200 tablets, 60 tablets
(S4) Prescription Only Medicine
Jorveza? is indicated for the treatment of eosinophilic oesophagitis (EoE) in adults.
Visual Identification: White or almost white, round, biplane tablet with a smooth surface and facet, one side embossed with "0.5"; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-09-06
JORVEZA V08 09/2021 1 JORVEZA ® _Budesonide 0.5 mg and 1 mg orally disintegrating tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about JORVEZA tablets. 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. Your doctor has weighed the risk of you taking this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT JORVEZA IS USED FOR JORVEZA tablets contain the active ingredient, budesonide. Budesonide belongs to a group of medications called corticosteroids. JORVEZA tablets are used to treat eosinophilic oesophagitis (EoE) which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. JORVEZA is only available on a doctor’s prescription. There is not enough information to recommend the use of this medicine for children or adolescents. BEFORE YOU TAKE JORVEZA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing budesonide • any ingredients listed at the end of this leaflet. 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 • rash, itching or hives on the skin. DO NOT TAKE JORVEZA IF YOU HAVE UNCONTROLLED INFECTIONS OR ACTIVE TUBERCULOSIS. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU HAVE ANY ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR IF YOU ARE Đọc toàn bộ tài liệu
JORVEZA ® PI v09 1221 1 AUSTR 322645/AUSTR 350996 pi-approved-1221 1 / 11 AUSTRALIAN PRODUCT INFORMATION – JORVEZA ® (BUDESONIDE) ORALLY DISINTEGRATING TABLETS 1. NAME OF THE MEDICINAL PRODUCT Budesonide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orally disintegrating tablet contains either 0.5 mg or 1 mg of budesonide. Each budesonide orally disintegrating tablet also contains sucralose and sodium. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Orally disintegrating tablet Jorveza ® 0.5 mg tablet: White or almost white, round, biplane orally disintegrating tablet with ‘0.5’ debossed on one side. Jorveza ® 1 mg tablet: White or almost white, round, biplane orally disintegrating tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jorveza ® is indicated for the treatment of eosinophilic oesophagitis (EoE) in adults. _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic oesophagitis. Dosage The recommended daily dose for induction treatment is 2 mg budesonide as one 1 mg tablet in the morning and one 1 mg tablet in the evening. The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks. If a dose is missed, treatment should be continued at the prescribed dosage. A double dose should not be used to make up for a forgotten dose. The recommended daily dose for maintenance of remission is 1 mg budesonide as one 0.5 mg tablet in the morning and one 0.5 mg tablet in the evening, or 2 mg budesonide as one 1 mg tablet in the morning and one 1 mg tablet in the evening, depending on the individual clinical requirement of the patient. The maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of oesophageal inflammation in their acute disease state, see a Đọc toàn bộ tài liệu