ONE-ALPHA Solution for injection (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 2 microgram/ml injection.
Qualitative and quantitative composition
Alfacalcidol 2 micrograms/ml. Excipients with known effect: Ethanol, sodium citrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, colourless liquid in 1 ml one-point-cut amber glass ampoule.
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 The dosage of One-Alpha Injection is the same as for One-Alpha in its oral presentations. Initial dosage for all indications: Adults and children over 20 kg bodyweight: 1 microgram/day Elderly: ...
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 on regular haemodialysis administration of doses between 1-4 micrograms of intravenous 1 α-hydroxyvitamin D3 resulted in increased levels of 1,25 dihydroxyvitamin D. Formation of 1,25 dihydroxyvitamin ...
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
Citric acid Ethanol Sodium citrate Propylene glycol Water for injection
Incompatibilities
None known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store at 2 to 8°C. Keep the ampoule in the outer carton in order to protect it from light.
Nature and contents of container
10 0.5 ml amber glass ampoules. 10 1.0 ml amber glass ampoules. Not all pack sizes may be marketed.
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)
PL 00043/0183
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 July 1991 Date of latest renewal: 11 November 2005
Date of revision of the text
March 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
