País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Colecalciferol
Consilient Health Limited
A11CC; A11CC05
Colecalciferol
25,000 international unit(s)
Oral solution
oral use
Pack with 1, 2, 3 or 4 ampoules
Product subject to prescription which may be renewed (B)
SMB Technology S.A
Vitamin D, colecalciferol
Vitamin D and analogues; colecalciferol
The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency
Marketed
2015-09-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALTAVITAD3 25,000 IU ORAL SOLUTION COLECALCIFEROL 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 quest ions, ask your doctor or pharmacist, or nurse. - This medicine has been prescribed for you only. Do not pass it onto 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 any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What altavitaD3 is and what it is used for 2. What you need to know before you use altavitaD3 3. How to use altavitaD3 4. Possible side effects 5. How to store altavitaD3 6. Contents of the pack and other informat ion 1. WHAT ALTAVITAD3 IS AND WHAT IT IS USED FOR altavitaD3 is a vitamin product containing colecalciferol (equivalent to vitamin D 3 ). Vitamin D can be found in some foods and also produced by the body when skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb calcium and it helps build bones. altavitaD3 25,000 IU is used: - for the prevent ion of vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D - with other medicines to treat certain bone condit ions, such as thinning of the bone (osteoporosis) - to treat vitamin D deficiency that has been confirmed by laboratory tests. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALTAVITAD3 DO NOT USE ALTAVITAD3 - if you are allergic to vitamin D or any of the other ingredients of altavitaD3 (listed in section 6) - if you have hypercalcaemia (high levels of calcium in the blood) - if you have hypercalciuria (high levels of calcium in the urine) - if you have pseudohypoparathyroidism (disturbed parathyro id hormone metabo lism) - if you have renal calculi (kidney stones) - if you have hypervitaminosis D (high levels of Leer el documento completo
Health Products Regulatory Authority 25 August 2020 CRN009T9M Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AltavitaD3 25,000IU oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml solution (1 single-dose oral solution) contains 0.625mg colecalciferol, equivalent to 25,000 IU vitamin D. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, slightly yellow, oily liquid with an orange odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Paediatric posology: - Prevention of deficiency 0-1 years 25,000 IU (1 single-dose oral solution) every 8 weeks. - Prevention of deficiency 1-18 years 25,000 IU (1 single-dose oral solution) every 6 weeks. - Treatment of deficiency 0-18 years 25,000 IU (1 single-dose oral solution) once every 2 weeks for 6 weeks (followed by maintenance therapy of 400-1000 IU/day, such as 1 25,000 IU single-dose oral solution) per month. Pregnancy and breastfeeding: - The high strength formulation is not recommended. Adults: - Prevention of vitamin D deficiency 25,000 IU/month (1 single-dose oral solution) Higher doses may be required in certain situations, see below - As an adjunct to specific therapy for osteoporosis: 25,000 IU/month (1 single-dose oral solution.) - Treatment of vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2 single-dose oral solutions) for 6-8 weeks, followed by maintenance therapy (1400-2000 IU /day may be required such as 50,000 IU (2 single-dose oral solutions) per month); follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. Certain populations are at high risk of vitamin D deficiency ,and may require higher doses and monitoring of serum 25(OH)D: - Leer el documento completo