国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
calcifediol
FAES FARMA
A11CC06
calcifediol
0,266mg
capsules
(5/1x5/) in blister
Prescription
Registered
2020-12-30
1 of 5 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 完全なドキュメントを読む
1 de 9 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. 2 de 9 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 完全なドキュメントを読む