国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Alfacalcidol
Leo Laboratories Limited
A11CC; A11CC03
Alfacalcidol
2 microgram(s)/millilitre
Oral drops, solution
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; alfacalcidol
Marketed
1999-07-26
PACKAGE LEAFLET: INFORMATION FOR THE USER ONE-ALPHA ® 2 MICROGRAMS/ML ORAL DROPS alfacalcidol 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet One-Alpha oral drops will be called One-Alpha. WHAT IS IN THIS LEAFLET: 1. What One-Alpha ® is and what it is used for 2. What you need to know before you take One-Alpha ® 3. How to take One-Alpha ® 4. Possible side effects 5. How to store One-Alpha ® 6. Contents of the pack and other information 1. WHAT ONE-ALPHA ® IS AND WHAT IT IS USED FOR One-Alpha contains the active substance alfacalcidol. One-Alpha belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth. One-Alpha works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. One-Alpha is used to treat diseases where the amount of calcium in your body needs to be changed. It is used to treat: Changes in bone caused by kidney failure (osteodystrophy). Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. The glands may make the amount of calcium in your blood too high (hyperparathyroidism). The glands may make the amount of calcium in your blood too low (hypopar 完全なドキュメントを読む
Health Products Regulatory Authority 11 December 2020 CRN009VYR Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT One-Alpha 2 micrograms/ml oral drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alfacalcidol 2 micrograms/ml. Each drop (0.05 millilitre) contains 0.1 micrograms (100 nanograms) alfacalcidol. Excipients with known effect: Ethanol equivalent to 14 vol%, methylparahydroxybenzoate (E218) 1.5 mg/ml, macrogolglycerol hydroxystearate 22.6 mg/ml, sorbitol (E420) 452 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution. Slightly turbid to clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS One-Alpha is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 a-hydroxylation such as when there is reduced renal function. The main indications are: a) Renal osteodystrophy b) Hyperparathyroidism (with bone disease) c) Hypoparathyroidism d) Neonatal hypocalcaemia e) Nutritional and malabsorptive rickets and osteomalacia f) Pseudo-deficiency (D-dependent) rickets and osteomalacia g) Hypophosphataemic vitamin D resistant rickets and osteomalacia. 4.2 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 20 kg bodyweight: 0.05 microgram/kg/day To administer this medicine hold the dropper in a vertical position, upside down. The drops should flow immediately but if they do not, tap the bottle gently. Do not shake the bottle. Half-drop doses should be rounded up to the next whole number of drops. Health Products Regulatory Authority 11 December 2020 CRN009VYR Page 2 of 7 Plasma levels should initially be measured at weekly intervals. The daily dose of One-Alpha may be increased by increments of 0.25-0.5 microgram. When the dose is stabilised, measurements may be taken every 2-4 weeks. Most adult 完全なドキュメントを読む