Pikovit D tablets coated

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

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

Fáanlegur frá:

KRKA d.d.

ATC númer:

A11AA03

INN (Alþjóðlegt nafn):

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

Skammtar:

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

Lyfjaform:

tablets coated

Einingar í pakka:

(30/2x15/) in blister

Gerð lyfseðils:

OTC

Leyfisstaða:

Registered

Leyfisdagur:

2019-10-11

Vara einkenni

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