Country: আর্মেনিয়া
ভাষা: ইংরেজি
সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
colecalciferol (vitamin D3)
KRKA d.d.
A11CC05
colecalciferol (vitamin D3)
1000IU
tablets
(30/3x10/) in blister, (60/6x10/) in blister, (90/9x10/) in blister
OTC
Registered
2021-07-26
PI_Text038905_1 – Updated: Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT Vitamin D3 Krka 1000 IU tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1000 IU of cholecalciferol, which corresponds to 10 mg of cholecalciferol concentrate (equivalent to 0.025 mg cholecalciferol). Excipients with known effect: Each tablet contains 1.93 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White or almost white, round, slightly biconvex tablets engraved with mark 2 on one side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prevention of vitamin D deficiency in adults, children and adolescents 6 to 18 years of age with an identified high risk. - Treatment of vitamin D deficiency in adults and adolescents 12 to 18 years of age. - In complex therapy of osteoporosis in adults, including postmenopausal, with vitamin D deficiency or an identified high risk of vitamin D deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _PREVENTION OF VITAMIN D DEFICIENCY IN ADULTS WITH AN IDENTIFIED HIGH RISK _ The recommended daily dose for adults is 1000 IU vitamin D (25 µg or 0.025 mg cholecalciferol). This corresponds to 1 Vitamin D3 Krka 1000 IU tablet daily. _TREATMENT OF VITAMIN D DEFICIENCY IN ADULTS_ This indication is not intended for self-medication. Treatment should be conducted by a physician. The dose should be determined based on the severity of the condition, the desired 25-hydroxyvitamin D level, and patient’s individual response to treatment. In general, the following dosage guidelines apply: - Initial treatment (6 to 12 weeks) CONFIDENTIAL Vitamin D3 Krka 1000 IU tablets MODULE 1 VOL: 1; P: 14 / 118 PI_Text038905_1 – Updated: Page 2 of 8 AGE GROUP CHOLECALCIFEROL DAILY DOSE NUMBER OF VITAMIN D3 KRKA 1000 IU TABLETS Adults 4000 IU vitamin D (100 µg or 0.1 mg cholecalciferol) 4 tablets daily - Maintenance dose AGE GROUP CHOLECALCIFEROL DAILY DOSE NUMBER OF VITAMIN D3 KRKA 1000 IU TABLETS Adults 2000 IU vitamin D (50 µg or 0. সম্পূর্ণ নথি পড়ুন