Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Disodium etidronate 200mg
Teva Pharma (New Zealand) Limited
Disodium etidronate 200 mg
200 mg
Tablet
Active: Disodium etidronate 200mg Excipient: Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified water
Blister pack, PVC/PE/PVDC/aluminium foil, 100 tablets, 100 tablets
Prescription
Prescription
Medichem SA
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/aluminium foil - 100 tablets - 3 years from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP closure - 100 tablets - 3 years from date of manufacture stored at or below 25°C
2006-08-18
ARROW - ETIDRONATE Disodium etidronate 200 mg Tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARROW - ETIDRONATE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ARROW - ETIDRONATE against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT ARROW - ETIDRONATE IS USED FOR Disodium etidronate, the active ingredient in ARROW - ETIDRONATE Tablets, belongs to a group of medicines called bisphosphonates. Bisphosphonates can be used to help bone diseases such as osteoporosis and Paget's disease. Your doctor may prescribe ARROW - ETIDRONATE to prevent and treat abnormal deposition of calcium in the bone. This condition may happen following spinal cord injury or total hip replacement. As part of the treatment, your doctor will give you calcium to take after completing the course of ARROW - ETIDRONATE. Your doctor may have prescribed ARROW - ETIDRONATE for another reason. Ask your doctor if you have any questions about why ARROW - ETIDRONATE has been prescribed for you. ARROW - ETIDRONATE SHOULD NOT BE GIVEN TO CHILDREN. There is no experience with the use of ARROW - ETIDRONATE in children. There is no evidence that ARROW - ETIDRONATE Tablets is additive. ARROW - ETIDRONATE is available only with a doctor's prescription. BEFORE YOU TAKE ARROW - ETIDRONATE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ARROW - ETIDRONATE IF YOU ARE ALLERGIC TO MEDICINES CONTAINING ETIDRONATE, BISPHOSPHONATES OR ANY OF THE 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 ARRO Прочитајте комплетан документ
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Arrow – Etidronate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of disodium etidronate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Off-white rectangular tablet marked “ED 2” on one side and ' ' on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OSTEOPOROSIS Etidronate is indicated for the treatment of osteoporosis in both men and women. This includes the prevention and treatment of corticosteroid induced osteoporosis and the prevention and treatment of osteoporosis in postmenopausal women. PAGET'S DISEASE Etidronate is indicated for the treatment of symptomatic Paget's disease of bone (osteitis deformans) when other therapy is considered inappropriate or cannot be tolerated. Effectiveness has been demonstrated primarily in patients with polyostotic Paget's disease with symptoms of pain and with clinically significant elevations of urinary hydroxyproline and serum alkaline phosphatase. In patients treated with etidronate at the dose of 5 mg/kg/day, the elevated urinary hydroxyproline and serum alkaline phosphatase decreased by 30% or more in about 4 out of 5 patients. Hydroxyproline either returned to normal or was decreased by at least 50% in about 3 out of 5 patients and alkaline phosphatase in about one-half of the patients. In controlled studies, approximately 3 out of 5 patients experienced decreased pain and/or improved mobility. Two out of 5 patients in the placebo group showed similar subjective improvement. Objective measurements in etidronate-treated patients have shown reductions of elevated cardiac output in about 2 out of 3 patients. Reductions in elevated skin temperature over Pagetic lesions have also been measured. The number of treated patients in these categories is still too small to predict with certainty how likely such a result will be in any given patient. Objective evidence of hearing improvement has not been demonstrated. The majority of patients with loca Прочитајте комплетан документ