Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TERIPARATIDE
ACCORD HEALTHCARE SDN.BHD.
TERIPARATIDE
3 Units; 1 Units
Intas Pharmaceuticals Limited Biopharma Division
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SONDELBAY SOLUTION FOR INJ IN PRE-FILLED PEN _Teriparatide 20 micrograms in 80 microliters _ 1 WHAT IS IN THIS LEAFLET 1. What Sondelbay is used for 2. How Sondelbay works 3. Before you use Sondelbay 4. How to use Sondelbay 5. While you are using it 6. Side effects 7. Storage and disposal of Sondelbay 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SONDELBAY IS USED FOR Sondelbay contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. Sondelbay is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids. Sondelbay is a biosimilar medicinal product of Forteo HOW SONDELBAY WORKS Teriparatide injection contains a synthetic form of natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness). BEFORE YOU USE SONDELBAY _When you must not use it _ • You must not use Sondelbay if you: • if you are allergic to teriparatide or any of the other ingredients of this medicine. • if you suffer from high calcium levels (pre-existing hypercalcaemia). • if you suffer from serious kidney problems. • if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to your bones. • if you have certain bone diseases. If you have a bone disease, tell your doctor. • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor. • if you have had radiation therapy involving your bones. • if you are pregnant or breast- feeding. _ _ Les hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains 20 micrograms of teriparatide* in 80 microliters. One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL). *Teriparatide, rhPTH(1-34), produced in _Escherichia coli_ , using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection (injection) Colourless, clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non- vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Sondelbay is 20 micrograms administered once daily. The maximum total duration of treatment with Sondelbay should be 24 months (see section 4.4). The 24-month course of Sondelbay should not be repeated over a patient’s lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of Sondelbay therapy, patients may be continued on other osteoporosis therapies. 2 Special populations _Elderly _ Dosage adjustment based on age is not required (see section 5.2). _Renal impairment _ Sondelbay must not be used in patients with severe renal impairment (see section 4.3.). In patients with moderate renal impairment, Sondelbay should be used with caution. No special caution is required for patients with mild renal impairment. _Hepatic i Les hele dokumentet