Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
vitamin A, vitamin D3, vitamin C, nicotinamide, calcium pantotenate, vitamin B2, vitamin B6, vitamin B1, folic acid, vitamin B12, calcium, phosphorus
KRKA d.d.
A11AA03
vitamin A, vitamin D3, vitamin C, nicotinamide, calcium pantotenate, vitamin B2, vitamin B6, vitamin B1, folic acid, vitamin B12, calcium, phosphorus
600IU+ 80IU+ 10mg+ 3mg+ 1,20mg+ 0,3mg+ 0,3mg+ 0,25mg+ 0,04mg+ 0,2mcg+ 12,5mg+ 10mg
tablets coated
(30/2x15/) in blister
OTC
Registered
2019-10-11
1.3.1 Pikovit D SPC, Labeling and Package Leaflet AM SmPCPIL126768_1 22.02.2019 – Updated: 22.02.2019 Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT Pikovit D coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains: - 600 IU vitamin A (retinolum) as retinyl palmitate, - 80 IU cholecalciferol (cholecalciferolum, vitamin D 3 ), - 10 mg ascorbic acid (acidum ascorbicum, vitamin C), - 3 mg nicotinamide (nicotinamidum), - 1.20 mg calcium pantothenate (calcii pantothenas), - 0.30 mg riboflavin (riboflavinum, vitamin B 2 ), - 0.30 mg pyridoxine hydrochloride (pyridoxini hydrochloridum, vitamin B 6 ), - 0.25 mg thiamine nitrate (thiamini nitras, vitamin B 1 ), - 0.04 mg folic acid (acidum folicum), - 0.20 µg cyanocobalamin (cyanocobalaminum, vitamin B 12 ), - 12.5 mg calcium (calcium) as anhydrous calcium hydrogen phosphate, - 10 mg phosphorus (phosphorus) as anhydrous calcium hydrogen phosphate. Excipients with known effect: - maltitol (E965): 449.18 mg/tablet - liquid maltitol: 461.00 mg/tablet - quinoline yellow (E104): 0.10 mg/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. The tablets are round, biconvex, yellow, orange, green and red. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pikovit D coated tablets are intended for the treatment of Hypovitaminosis and avitaminosis in children, which is caused by inadequate intake or increased needs for vitamins. These conditions can occur, for example, in the following instances: lack of appetite, increased physical and psychological stress, during irregular or incomplete diet or after antibiotic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This product is intended for use in children 4 years of age and older. Posology Children from 4 to 6 years of age: 1 coated tablet 4 times a day. Children from 7 to 14 years of age: 1 coated tablet 5 times a day. 1.3.1 Pikovit D SPC, Labeling and Package Leaflet AM SmPCPIL126768_1 22.02.2019 – Updated: 22.02.2019 Page 2 of 8 In case of poor appetit Read the complete document