ELEVIT

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Enheder i pakken:

DUS, 5 STRIP @ 6 TABLET SALUT SELAPUT

Autorisation dato:

2023-01-25

Produktets egenskaber

RESTRICTED
ELEVIT
1.
NAME OF THE MEDICINAL PRODUCT
Elevit.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition in terms of the active ingredient(s) (INN):
Elevit is a preparation containing multivitamins in combination with
minerals and trace
elements.
Quantitative composition in terms of the active ingredient(s) per
dosage form:
VITAMINS:
Vitamin B1 (Thiamine as Thiamine nitrate)
1.4 mg
Vitamin B2 (Riboflavin)
1.4 mg
Vitamin B3 (Nicotinamide)
18 mg
Vitamin B5 (Pantothenic acid as Calcium pantothenate)
6 mg
Vitamin B6 (Pyridoxine as Pyridoxine hydrochloride)
1.9 mg
Vitamin B7 (Biotin)
0.03 mg
Vitamin B9 (Folate as - folic acid
and L-methylfolate calcium)
800 mcg
Vitamin B12 (Cyanocobalamin)
2.6 mcg
Vitamin C (Ascorbic acid)
85 mg
Vitamin D3 (Colecalciferol)
1000 IU
Vitamin E (dl-alpha-tocopherol as
15 mg
dl-alpha-tocopheryl acetate)
MINERALS AND TRACE ELEMENTS:
Calcium (as Calcium hydrogen phosphate,
125 mg
Calcium pantothenate and L-methylfolate calcium)
Copper (as Cupric sulfate anhydrous)
1 mg
Iodine (as Potassium iodide)
220 mcg
Iron (as Ferrous bisglycinate)
27 mg
Magnesium (as Magnesium oxide, heavy)
100 mg
Manganese (as Manganese sulfate monohydrate)
2 mg
Selenium (as Sodium selenite)
50 mcg
Zinc (as Zinc citrate trihydrate)
11 mg
For the full list of excipient(s) see section ’List of
excipients’.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Elevit is a white to slightly greyish oval and biconvex film coated
tablet.
DISETUJUI OLEH BPOM: 16 JANUARI 2023
ID: EREG10036612100088
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4.
CLINICAL PARTICULARS
4.1.
Indication(s)
Multivitamin/ multimineral preparation for the prevention and
correction of vitamin and mineral
deficiencies in preparation for pregnancy as doctor recommendation,
during pregnancy and
lactation.
4.2.
Dosage and method of administration
4.2.1.
Method of administration
For oral use.
4.2.2.
Dosage regimen
One tablet daily to be taken as a whole with a glass of water
preferably with a meal. In case
of morning sickness, it is recommended that the tablet is taken at
noo