Hidroferol capsules

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

calcifediol

可用日期:

FAES FARMA

ATC代码:

A11CC06

INN（国际名称）:

calcifediol

剂量:

0,266mg

药物剂型:

capsules

每包单位数:

(5/1x5/) in blister

处方类型:

Prescription

授权状态:

Registered

授权日期:

2020-12-30

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HIDROFEROL 0.266 MG SOFT CAPSULES
Calcifediol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes possible side effects
not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Hidroferol is and what it is used for
2.
Before you need to know before you take Hidroferol
3.
How to take Hidroferol
4.
Possible side effects
5.
How to store Hidroferol
6.
Contents of the pack and further information
1.
WHAT HIDROFEROL IS AND WHAT IT IS USED FOR
It contains a form of vitamin D, calcifediol, which is used to treat
vitamin D deficiency and derived
problems, when you need to start with high doses or spaced
administration in the time is required.
Vitamin D is involved in the human body, among others, to increase the
calcium absorption.
Hidroferol is used:
In adults:
In the treatment of vitamin D deficiency, in cases where initial
administration of high doses is required or
administration spaced in time is desirable, as in the following
situations:
-
For supportive treatment of osteoporosis
-
In patients with malabsorption syndrome (difficulty to absorb
nutrients)
-
Osteodystrophy (bone problems) or lack of calcium in patients with
kidney failure
-
Bone problems caused by corticosteroid drugs (anti-inflammatory used
in various diseases).
2.
BEFORE YOU NEED TO KNOW BEFORE YOU TAKE HIDROFEROL
DO NOT TAKE HIDROFEROL:
-
If you are allergic to calcifediol or any of the other ingredients of
this medicine (listed in section
6).
-
If you suffer from hypercalcaemia (calcium levels in the blood >10.5
mg/dl) or hypercalciuria
(high calc

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hidroferol0.266 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.266 mg of calcifediol (equivalent to 15.960 UI
of Vitamin D).
Excipients with known effect:
Each capsule contains 4.98 mg of ethanol, 31.302 mg of sorbitol
(E-420), 0.958 mg of sunset yellow (E-
110) and other excipients.
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Orange, oval soft gelatine capsule
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults:
Treatment of vitamin D deficiency, in those cases where the initial
administration of high doses is required
or administration spaced in time is preferred, as in the following
situations:

As adjuvant for the treatment of osteoporosis

In patients with malabsorption syndrome

Renal ostheodystrophy

Bone diseases induced by treatment with corticosteroid drugs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dietary intake of vitamin D and sun exposure vary among patients and
should be taken into account when
calculating the appropriate dose of vitamin D analoguedrugs such as
calcifediol.
The dose, frequency and duration of the treatment will be determined
according to plasma levels of 25-OH-
cholecalciferol, type and condition of the patient and other
comorbidities such as obesity, malabsorption
syndrome, treatment with corticosteroids. The dose to be administered
should produce serum calcium
levels between 9-10 mg/dl.
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Determination of 25-OH-cholecalciferol in plasma is considered the
most accepted way to diagnose
vitamin D deficiency. It is accepted that Vitamin D deficiency
existswhen serum levels of 25-OH-
cholecalciferol are< 20 ng/ml, while insufficiency of vitamin D
existswhen serum levels of 25-OH-
cholecalciferol are between 20 and 24 ng/ml.
In normal subjects mean serum concentrations are between 25 and 40
ng/ml of 25-OH-cholecalciferol.
The recommended dose is one capsule (0.266 mg of calcifediol) once a
month.

Vita