দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BUDESONIDE
RAFA LABORATORIES LTD
A07EA06
TABLETS ORODISPERSIBLE
BUDESONIDE 0.5 MG
PER OS
Required
DR. FALK PHARMA, GERMANY
BUDESONIDE
Treatment of eosinophilic esophagitis (EoE) in adults.
2023-03-22
1 Patient Leaflet According to the Pharmacists' Regulations (Preparations) – 1986 This medicine is sold with a doctor's prescription only Jorveza® 0.5 mg Jorveza® 1 mg Orodispersible tablets Active ing redient: Each Jorveza 0.5 mg orodispersible tablet contains: 0.5 mg budesonide. Each Jorveza 1 mg orodispersible tablet contains: 1 mg budesonide. For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. Read this entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is the medicine intended for? The medicine is intended for the treatment of eosinophilic esophagitis in adults. Therapeutic group: steroidal (corticosteroidal) anti-inflammatory medicine with local activity. 2. Before using the medicine Do not use the medicine if: You are sensitive (allergic) to the active ingredient (budesonide) or to any of the other ingredients the medicine contains (for a list of the other ingredients, see section 6). Special warnings regarding the use of this medicine: Before starting the treatment with the medicine, tell your doctor if: • You have tuberculosis, high blood pressure, osteoporosis. • You or someone in your family has diabetes. • You have ulcers in the stomach or in the intestine. • You have increased pressure in your eye (which can cause glaucoma), glaucoma, eye problems such as clouding of the lens (cataract), or if someone in your family has glaucoma. • You have liver or kidney disease. If you have any of the conditions mentioned above, you may be at an increased risk of side effects. Your doctor will decide whether the medicine is suitable for you and whether appropriate monitoring is necess সম্পূর্ণ নথি পড়ুন
1 Jorveza 1 mg-DL-April 2023 1. NAME OF THE MEDICINAL PRODUCT Jorveza 0.5 mg Jorveza 1 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jorveza 0.5 mg orodispersible tablets Each orodispersible tablet contains 0.5 mg of budesonide. _ _ _Excipient with known effect _ Each 0.5 mg orodispersible tablet contains 26 mg sodium. Jorveza 1 mg orodispersible tablets Each orodispersible tablet contains 1 mg of budesonide. _ _ _Excipient with known effect _ Each 1 mg orodispersible tablet contains 26 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible white round tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment with this medicinal product should be initiated by a gastroenterologist or a physician experienced in the diagnosis and treatment of eosinophilic esophagitis. Posology _Induction of remission _ _ _ The recommended daily dose 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. _Maintenance of remission_ The recommended daily dose 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 1-mg-tablet in the morning and one 1-mg-tablet in the evening, depending on the individual clinical requirement of the patient. A maintenance dose of 1 mg budesonide twice daily is recommended for patients with long standing disease history and/or high extent of esophageal inflammation in their acute disease state, see also section 5.1. The duration of maintenance therapy is determined by the treating physician. _Special populations _ _Renal impairment _ 2 There are currently no data available for patients with renal impairment. Because budesonide is not excreted via the kidneys, patie সম্পূর্ণ নথি পড়ুন