Pikovit D tablets coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

vitamin A, vitamin D3, vitamin C, nicotinamide, calcium pantotenate, vitamin B2, vitamin B6, vitamin B1, folic acid, vitamin B12, calcium, phosphorus

제공처:

KRKA d.d.

ATC 코드:

A11AA03

INN (International Name):

vitamin A, vitamin D3, vitamin C, nicotinamide, calcium pantotenate, vitamin B2, vitamin B6, vitamin B1, folic acid, vitamin B12, calcium, phosphorus

복용량:

600IU+ 80IU+ 10mg+ 3mg+ 1,20mg+ 0,3mg+ 0,3mg+ 0,25mg+ 0,04mg+ 0,2mcg+ 12,5mg+ 10mg

약제 형태:

tablets coated

패키지 단위:

(30/2x15/) in blister

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2019-10-11

제품 특성 요약

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