국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALCATONIN/CALCITONIN SALMON
ZUELLIG PHARMA SDN BHD
SALCATONIN/CALCITONIN SALMON
1Units Units; 1 Units Units
Delpharm Huningue S.A.S.
MIACALCIC ® NASAL SPRAY Synthetic salmon calcitonin (200IU/metered dose) 1 WHAT IS IN THIS LEAFLET 1. What _Miacalcic Nasal Spray_ is used for 2. How _Miacalcic Nasal Spray_ works 3. Before you use _Miacalcic Nasal _ _Spray_ 4. How to use _Miacalcic Nasal Spray_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Miacalcic _ _Nasal Spray_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MIACALCIC NASAL SPRAY_ IS USED FOR _PREVENTION OF OSTEOPOROSIS _ In acute bone loss due to sudden immobilization such as in patients with osteoporotic fractures. Miacalcic should be supplemented with adequate doses of calcium and vitamin D, as needed by the individual patient, to prevent further loss of bone mass. The maximum duration of treatment is 3 months. _PAGET’S DISEASE (OSTEITIS DEFORMANS): _ Only in patients who do not respond to alternative treatments or for whom alternative treatments are not suitable: The duration of treatment is normally 3 months (also refer to HOW TO USE MIACALCIC NASAL SPRAY ). _ALGODYSTROPHY _ _OR _ _SUDECK’S _ _DISEASE _ _(NEURODYSTROPHIC DISORDERS): _ Neurodystrophic disorders due to various causes and predisposing factors such as post- traumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia and drug- induced neurotrophic disorders. The duration of treatment is up to 6 weeks. HOW _MIACALCIC NASAL SPRAY_ WORKS Calcitonin regulates the level of calcium in the blood. It is used to reverse bone loss and it is thought that it may also help in bone formation. If you have any questions about how Miacalcic works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE _MIACALCIC NASAL SPRAY _ • _When you must not use it_ _ _ _Allergic reactions _ Since salmon calcitonin is a polypeptide, allergic reactions are possible. Allergic- type reactions, including isolated cases of anaphylactic shock, have been reported in patients receiving Miacalcic. In patients with suspected hypersensi 전체 문서 읽기
Page 1 Malaysian Package Leaflet Miacalcic Nasal Spray Miacalcic Nasal Spray Regulator of calcium homeostasis . DESCRIPTION AND COMPOSITION Pharmaceutical form Nasal spray solution in bottles fitted with a metering pump delivering at least 14 doses of 200 IU salmon calcitonin per actuation. Active substance T he active substance is synthetic salmon calcitonin (INN name c alcitonin). One metered dose delivers 200 IU of synthetic salmon calcitonin. One International Unit (= IU) corresponds to about 0.2 micrograms of synthetic salmon calcitonin. Active moiety Salmo n calcitonin . Excipients Benzalkonium chloride, sodium chloride, hydrochloric acid (for pH adjust ment), water (purified, Eur.P.) . DESCRIPTION Clear, colourless solution. INDICATIONS Miacalcic Nasal Spray is indicated for the treatment of: Prevention of os teoporosis In acute bone loss due to sudden immobilization such as in patients with osteoporotic fractures (see PHARMACODYNAMICS ). Miacalcic should be supplemented with adequate doses of calcium and vitamin D, as needed by the individual patient, to preve nt further loss of bone mass. The maximum duration of treatment is 3 months. Paget’s disease (osteitis deformans): Only in patients who do not respond to alternative treatments or for whom alternative treatments are not suitable: The duration of treatment is normally 3 months (also refer to DOSAGE AND ADMINISTRATION). Algodystrophy or Sudeck’s disease (neurodystrophic disorders): 전체 문서 읽기