País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Cholecalciferol
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol
50,000 international unit(s)
Oral solution
Oral use
pack with 1, 2, 3, 4, 5 or 6 single dose
Product subject to prescription which may be renewed (B)
SMB Technology S.A
Vitamin D, colecalciferol
Vitamin D and analogues; colecalciferol
For the treatment of vitamin D deficiency
Not marketed
2015-07-10
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 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 information 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 50,000 IU is used 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 parathyroid hormone metabolism) • if you have renal calculi (kidney stones) • if you have hypervitaminosis D (high levels of vitamin D in the blood). Warnings and precautions Talk to your doctor, pharmacist or nurse before using altavitaD3 if you: • are undergoing treatment with certain medicines used to treat heart disorders (e.g., cardiac glycosides, such as digoxin) • have sarcoidosis (an immune system disorder which may cause Leer el documento completo
Health Products Regulatory Authority 15 September 2023 CRN00DTS3 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Altavita D3 50,000 IU oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1mlsolution(1single-doseoralsolution)contains1.25mgcolecalciferol,equivalentto 50,000IUvitaminD3. Forafulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Oralsolution. Clear,slightlyyellow,oilyliquidwithanorangeodour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ThetreatmentofvitaminDdeficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Paediatricposology: Duetoalackofclinicaldata,altavitaD3isnotrecommended. Pregnancyandbreastfeeding: Duetoalackofclinicaldata,altavitaD3isnotrecommended. Adults: TreatmentofvitaminDdeficiency(<25nmol/l)50,000IU/week(1single-doseoralsolution)for6-8 weeks,followedbymaintenancetherapy(equivalentto1400-2000IU/day,suchas1single-dose 50,000IUoralsolutionpermonth)mayberequired;follow-up25(OH)Dmeasurementsshouldbe madeapproximatelythreetofourmonthsafterinitiatingmaintenancetherapy toconfirmthatthetarget levelhasbeenachieved). CertainpopulationsareathighriskofvitaminDdeficiency,andmayrequirehigherdoses andmonitoringofserum25(OH)D: Institutionalisedorhospitalisedindividuals Darkskinnedindividuals Individualswithlimitedeffectivesunexposureduetoprotectiveclothingorconsistentuseofsun screens Obeseindividuals Patientsbeing evaluatedforosteoporosis Useofcertain concomitantmedications(e.g.,anticonvulsantmedications,glucocorticoids) Patientswithmalabsorption,includinginflammatoryboweldiseaseandcoeliacdisease ThoserecentlytreatedforvitaminDdeficiency,andrequiringmaintenancetherapy. Health Products Regulatory Authority 15 September 2023 CRN00DTS3 Page 2 of 6 Specialpopulations _Renalimpairment_ altavitaD3shouldnotbeusedincombinationwithcalciuminpatientswithsevererenalimpairment. _Hepaticimpairment_ Noposologyadjustmentisrequiredinpatientswithhepaticimpairment. Methodofadministration PatientsshouldbeadvisedtotakealtavitaD3preferab Leer el documento completo