One-Alpha caps. 0.25 mcg

Šalis: Jordanija

kalba: anglų

Šaltinis: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Veiklioji medžiaga:

Alfacalcidol 0.25 mcg

Prieinama:

الشركة العربية للمستحضرات الطبية والزراعية - Arab Company for Medical & Agricultural Products

ATC kodas:

A11CC03

INN (Tarptautinis Pavadinimas):

Alfacalcidol 0.25 mcg

Dozė:

0.25 mcg

Vienetai pakuotėje:

30 caps

Pagaminta:

ليو فارما برودكتس (الدانمارك)

Produkto santrauka:

4.14 :سعر الجمهور + الضريبة

Pakuotės lapelis

053622
Scale Get-up Item No. Rev. No. Sent by e-mail
Subject Date Date Date
Colour Sign. Sign. Sign.
Preparation Supplier / Place of production
Strength
Comments:
▲
100%
E+A V
053622
N/A
RBE
EBD
Black
One-Alpha
®
- capsules, drops, injection
Page 1 of 2 Pointsize: 5,8 pt
Denmark
27/06/16 16/12/16
INS 170 x 320 mm
LEO
1. NAME OF MEDICINAL PRODUCT
One-Alpha
®
Alfacalcidol
Carefully read this insert before administering this product. It
contains
information about your treatment. If you have any doubt or you are not
sure about something, please ask your physician or Pharmacist chemist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one prescribed by your
physician.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
Alfacalcidol 0.25 microgram, 0.5 microgram and 1 microgram
Pack sizes: 10, 30, 50 and 100 capsules
Excipients the clinician should be aware of: Sesame oil
DROPS
Alfacalcidol 2 micrograms/ml (one drop provides 0.1 microgram)
Excipients the clinician should be aware of: Ethanol, sorbitol, methyl
parahydroxybenzoate, macrogolglycerol hydroxystearate
Pack sizes: 10 ml and 20 ml
SOLUTION FOR INJECTION
Alfacalcidol 2 micrograms/ml (for i.v. use)
Pack sizes: 0.5 ml x 10 ampules and 1 ml x 10 ampules
List of excipients, see section 6.1
Not all pack sizes, strengths and formulations may be marketed
3. PHARMACEUTICAL FORM
CAPSULES
Soft capsules; cream-coloured (0.25 microgram), pink (0.5 microgram),
or brownish (1 microgram)
DROPS
Oral drops; slightly cloudy to clear, colourless
SOLUTION FOR INJECTION
Solution for injection (for i.v. use); clear and colourless
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diseases caused by disturbances in the calcium metabolism in
consequence of reduced endogenous
production of 1.25-dihydroxyvitamin D
3
. Renal osteodystrophy, postoperative or idiopathic
hypo-parathyroidism, pseudohypoparathyroidism, as an adjunct to the
management of tertiary
hyperparathyroidism, vitamin D-resistant rickets or osteomalacia,
vitamin D-d