Vitamin D3 Krka tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

colecalciferol (vitamin D3)

Disponibil de la:

KRKA d.d.

Codul ATC:

A11CC05

INN (nume internaţional):

colecalciferol (vitamin D3)

Dozare:

1000IU

Forma farmaceutică:

tablets

Unități în pachet:

(30/3x10/) in blister, (60/6x10/) in blister, (90/9x10/) in blister

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-07-26

Caracteristicilor produsului

PI_Text038905_1
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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
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PI_Text038905_1
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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.