البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
Teriparatide, Quantity: 0.25 mg/mL
Generic Health Pty Ltd
Injection, solution
Excipient Ingredients: glacial acetic acid; water for injections; sodium acetate; cresol; mannitol; hydrochloric acid; sodium hydroxide
Subcutaneous
1 x pre-filled cartridge, 3 x pre-filled cartridge
(S4) Prescription Only Medicine
Teriparatide Lupin is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. ,Teriparatide Lupin is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.
Visual Identification: Clear, colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2023-04-05
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – TERIPARATIDE LUPIN (TERIPARATIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Teriparatide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled pen of Teriparatide Lupin of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. Teriparatide Lupin is a sterile, colourless, clear, isotonic solution in pre-filled pens. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teriparatide Lupin is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. Teriparatide Lupin is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture. 4.2 DOSE AND METHOD OF ADMINISTRATION Each dose of 80 microlitres contains 20 micrograms of teriparatide. The recommended dose of Teriparatide Lupin is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. Based on clinical experience, treatment with Teriparatide Lupin is recommended for a lifetime duration of 24 months treatment (for post-treatment efficacy, see SECTION 5.1 PHARMACODYNAMIC PROPERTIES - Teriparatide Lupin-pi-v1 Page 2 of 24 (teriparatide) solution for injection CLINICAL TRIALS). Teriparatide Lupin should be prescribed to patients with a full explanation and their informed consent on the lifetime duration of 24 months treatment. Calcium and vitamin D supplements are advised in patients with a low dietary intake of these nutrients. USE IN MALES – Primary or secondary h اقرأ الوثيقة كاملة