ONE-ALPHA Capsules (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
One-Alpha 1 microgram soft capsules. One-Alpha 0.25 microgram soft capsules. One-Alpha 0.5 microgram soft capsules.
Qualitative and quantitative composition
Each capsule contains 1 microgram of alfacalcidol. Each capsule contains 0.25 micrograms of alfacalcidol. Each capsule contains 0.5 micrograms of alfacalcidol. Excipient with known effect: Sesame oil. ...
Pharmaceutical form
One-Alpha 1 microgram soft capsules: Brown, egg-shaped soft gelatin capsules, holding 0.1 g oily solution. One-Alpha 0.25 microgram soft capsules: Cream-coloured, egg-shaped soft gelatin capsules, holding ...
Therapeutic indications
One-Alpha is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1-α hydroxylation such as when there is reduced renal function. The main indications are: Renal ...
Posology and method of administration
Posology Initial dose for all indications: Adults and children over 20 kg bodyweight: 1 microgram/day Elderly: 0.5 microgram/day Neonates and premature infants: 0.05-0.1 microgram/kg/day Children under ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypercalcaemia, metastatic calcification.
Special warnings and precautions for use
During treatment with One-Alpha, serum calcium and serum phosphate levels should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. PTH, alkaline ...
Interaction with other medicinal products and other forms of interaction
Thiazide diuretics and calcium containing preparations Concurrent use of thiazide diuretics or calcium containing preparations may enhance the risk of hypercalcaemia. Calcium levels should be monitored. ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data from the use of alfacalcidol in pregnant women. Studies in animals have shown reproductive toxicity at high doses. Therefore, One-Alpha is not recommended during ...
Effects on ability to drive and use machines
Alfacalcidol has no or negligible direct influence on the ability to drive and use machines. However, the patient should be informed that dizziness may occur during treatment and take this into account ...
Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. The most frequently reported undesirable effects are various ...
Overdose
Excessive intake of One-Alpha may lead to the development of hypercalcaemia, however, the effect is reversed rapidly on withdrawal. In severe cases of hypercalcaemia general supportive measures should ...
Pharmacodynamic properties
Pharmacotherapeutic group: Vitamin D and analogues ATC code: A11CC03 Alfacalcidol is converted rapidly in the liver to 1,25-dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator ...
Pharmacokinetic properties
In patients with renal failure, 1-5 µg/day of 1α-hydroxyvitamin D (1α-OHD3) increased intestinal calcium and phosphorus absorption in a dose-related manner. This effect was observed within 3 days of starting ...
Preclinical safety data
The non-clinical toxicity of alfacalcidol is attributed to the known vitamin D-effect of calcitriol on calcium homeostasis, which is characterised by hypercalcaemia, hypercalciuria and eventually soft ...
List of excipients
One-Alpha1 microgram soft capsules: Sesame oil All-rac-α-tocopherol Gelatine Glycerol Potassium sorbate Black iron oxide Red iron oxide One-Alpha0.25 microgram soft capsules: Sesame oil All-rac-α-tocopherol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life One-Alpha 1 microgram soft capsules: 3 years. One-Alpha 0.25 microgram soft capsules: 3 years. One-Alpha 0.5 microgram soft capsules: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.
Special precautions for disposal and other handling
None.
Marketing authorization holder
LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
Marketing authorization number(s)
One-Alpha 1 microgram soft capsules: PL 00043/0050 One-Alpha 0.25 microgram soft capsules: PL 00043/0052 One-Alpha 0.5 microgram soft capsules: PL 00043/0206
Date of first authorization / renewal of the authorization
Date of first authorisation: One-Alpha 1 microgram soft capsules: 26 January 1978 One-Alpha 0.25 microgram soft capsules: 25 January 1978 One-Alpha 0.5 microgram soft capsules: 22 September 1999 Date of ...
Date of revision of the text
November 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
