Nazione: Sudafrica
Lingua: inglese
Fonte: South African Health Products Regulatory Authority (SAHPRA)
Strides Pharma (SA) (Pty) Ltd
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CAPSULES
EACH CAPSULE CONTAINS ALFACALCIDOL 0,5 ug
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Strides Pharma SA (Pty) Ltd Date: 09 March 2021 Page 1 of 9 J.Viljoen PROPOSED PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 CALCILOS 0,25 ΜG CAPSULES, CALCILOS 0,5 ΜG CAPSULES, CALCILOS 1 ΜG CAPSULES ALFACALCIDOL CONTAINS SUGAR: Sorbitol 10 mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CALCILOS Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. CALCILOS has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. _ _ _ _ WHAT IS IN THIS LEAFLET 1. What CALCILOS is and what it is used for 2. What you need to know before you take CALCILOS 3. How to take CALCILOS 4. Possible side effects 5. How to store CALCILOS 6. Contents of the pack and other information 1. WHAT CALCILOS IS AND WHAT IT IS USED FOR Alfacalcidol belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Strides Pharma SA (Pty) Ltd Date: 09 March 2021 Page 2 of 9 J.Viljoen Vitamin D controls the levels of calcium and phosphate in your body. Your body needs both of these substances for healthy bones and teeth. Alfacalcidol works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. CALCILOS is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat: Changes in bone caused by kidney failure (renal bone disease). Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. o The glands may make the amount of calcium in your blood too low (hypoparathyroidism). o The glands may make the amount of calcium in your blood too high (hyperparathyroidism). Softening and deformity of the bones due to lack of calcium, phosphorus or vitamin D (rickets or Leggi il documento completo
Strides Pharma SA (Pty) Ltd Date: 09 March 2021 Page 1 of 11 J.Viljoen PROPOSED PROFESSIONAL INFORMATION SCHEDULING STATUS S4 1 NAME OF THE MEDICINE CALCILOS 0,25 µg capsules CALCILOS 0,5 µg capsules CALCILOS 1 µg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CALCILOS 0,25 ΜG CAPSULES: Each capsule contains 0,25 µg alfacalcidol. CALCILOS 0,5 ΜG CAPSULES: Each capsule contains 0,50 µg alfacalcidol. CALCILOS 1 ΜG CAPSULES: Each capsule contains 1 µg alfacalcidol. Excipient: Contains 98,7 mg arachis oil (peanut oil). Contains sugar: Sorbitol 10 mg. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM CALCILOS 0,25 µg capsules: Reddish brown coloured, oval shaped soft gelatine capsules containing clear oily liquid. CALCILOS 0,5 µg capsules: Light pink coloured, oval shaped soft gelatine capsules containing clear oily liquid. CALCILOS 1 µg capsules: Pale yellow coloured, oval shaped soft gelatine capsules containing clear oily liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strides Pharma SA (Pty) Ltd Date: 09 March 2021 Page 2 of 11 J.Viljoen a) Renal osteodystrophy b) Hypoparathyroidism c) Hyperparathyroidism (with bone disease) d) Hypophosphataemic vitamin D resistant rickets and osteomalacia e) Pseudo-deficiency (vitamin D-dependent) rickets f) Nutritional and malabsorptive rickets and osteomalacia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY INITIAL DOSE FOR ALL INDICATIONS _Adults:_ 1 µg daily _Children 20 kg body weight and above:_ 1 µg daily _Children less than 20 kg body weight:_ 0,05 µg/kg daily Elderly: 0,5 μg daily It is important to adjust dosage thereafter according to the biochemical responses and to avoid hypercalcaemia. Indices of response include levels of plasma calcium, alkaline phosphatase, parathyroid hormone, urinary calcium excretion as well as radiographic and histological investigations. Correct plasma levels should initially be measured at weekly intervals. The daily dose of Alfacalcidol may be increased by increments of 0,25 – 0,5 μg. Leggi il documento completo