देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
calcium (calcium carbonate), colecalciferol
Losan Pharma GmbH
առկա չէ (A12AX)
calcium (calcium carbonate), colecalciferol
1000mg+ 22mcg(880IU)
tablets effervescent
(20) in plastic container
Prescription
Registered
2022-04-12
SPECIFICATION - DENK PHARMA product name: CalciD-Denk artwork: leaflet language(s): EN, FR, PT material number: 5201/003 revision of text: 03/2021 open format: 420 x 200 mm fold: 1 x pre-folded (Einbruchfalz) folded format: 210 x 200 mm pharma code: 676 paper grammar: 40 g/m 2 printing colours: PANTONE YELLOW C BLACK revision/date: 1 / 22.03.2021, KRi 2 / 31.03.2021, KRi 3 / 01.04.2021, KRi 4 / 01.04.2021, KRi 5 / 16.04.2021, KRi 6 / 16.04.2021, KRi _CalciD-Denk_ Effervescent tablet | oral use Mineral and vitamin combi‑ nation preparation Active ingredients: calcium and vitamin D 3 (colecalciferol) For use in adults Package leaflet: Information for the patient READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doc‑ tor or pharmacist has told you. – Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – If you get any side effects, talk to your doctor or pharmacist. This in‑ cludes any possible side effects not listed in this leaflet. See section 4. – You must talk to a doctor if you do not feel better or if you feel worse. What is in this leaflet 1. WHAT CALCID‑DENK IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCID‑DENK 3. HOW TO TAKE CALCID‑DENK 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CALCID‑DENK 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What CalciD-Denk is and what it is used for CalciD‑Denk is a combined mineral and vita‑ min product for the treatment of calcium and vitamin D deficiency states. It is used: • as an addition to treatments for osteoporo‑ sis (a skeletal disorder with decreased bone mass) in patients with simultaneous calcium and vitamin D deficiency. • to correct a simultaneous calcium and vitamin D deficiency in the elderly. You must talk to a doctor if you do not feel better or if you feel worse. 2. What you need to know पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CalciD-Denk 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: calcium, colecalciferol Each effervescent tablet contains 1,000 mg calcium (as calcium carbonate) and 22 µg colecalciferol (vitamin D 3 , equivalent to 880 I.U.). Excipients with known effect: Each effervescent tablet contains 396 mg lactose monohydrate, 3.7 mg sucrose, 94.5 mg sodium and soya oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Effervescent tablet Round, white to off-white biplane effervescent tablets with bevelled edges on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As support for a specific osteoporosis treatment in patients with proven or high risk of simultaneous calcium and vitamin D deficiencies. Compensation for simultaneous calcium and vitamin D deficiency in the elderly. Calcium carbonate and colecalciferol are for use by adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 effervescent tablet once a day. _Paediatric population_ Calcium carbonate and colecalciferol are not intended for use in children and adolescents. _Dosage in patients with hepatic impairment_ No dose adjustment is required. _Dosage in patients with renal impairment_ Calcium carbonate and colecalciferol are not permitted to be used in patients with severe renal impairment. 2 Method of administration Oral ingestion after dissolving. The effervescent tablets are to be dissolved in a glass of water for immediate drinking. Length of use Treatment of the calcium deficiency and osteoporosis is to be applied for the long term. Treatment duration is based on the targeted therapeutic goal. 4.3 CONTRAINDICATIONS Calcium carbonate and colecalciferol are not permitted to be used in patients with: - Hypersensitivity to the active substances, soy, peanuts, or any of the excipients listed in section 6.1. - Illnesses or circumstances that can cause hypercalcaemia or hypercalciuria. - Severe renal insufficiency. - Kidney stones, nephrocalc पूरा दस्तावेज़ पढ़ें