Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
COLECALCIFEROL
SYRI Limited, t/a Thame Laboratories
A11CC05
COLECALCIFEROL
3000 IU/ML
Oral Solution
Product subject to prescription which may be renewed (B)
colecalciferol
Not Marketed
2015-01-30
PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL 3000 IU/ML 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 questions, ask your doctor or pharmacist. ► 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Colecalciferol 3000 IU/ml Oral Solution but it will be referred to as Colecalciferol Oral Solution or Colecalciferol throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Colecalciferol Oral Solution is and what it is used for 2. What you need to know before you take Colecalciferol Oral Solution 3. How to take Colecalciferol Oral Solution 4. Possible side effects 5. How to store Colecalciferol Oral Solution 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL ORAL SOLUTION IS AND WHAT IT IS USED FOR Colecalciferol Oral Solution is an oily solution which contains the active substance called colecalciferol (Vitamin D 3 ). Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. Vitamin D 3 is also essential for bone formation and normal bone metabolism. Colecalciferol Oral Solution is used for prevention and treatment of Vitamin D deficiency in adults, elderly and children over 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL ORAL SOLUTION DO NOT TAKE COLECALCIFEROL : ► If you are allergic (hypersensitive) to colecalciferol or any of the other ingredients of this medicine (listed in section 6). ► If you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria). ► If you ha Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colecalciferol 3000IU/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Colecalciferol Oral Solution contains the active substance, colecalciferol. Each ml contains 3000IU colecalciferol. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution A clear, yellow coloured solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colecalciferol is indicated for treatment and prevention of vitamin D deficiency in adults, elderly and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration For oral use Posology The dosage regimen based on the ‘National Osteoporosis Society Guideline 2013’ proposed for Colecalciferol 3000IU/ml Oral Solution in the treatment and prevention of vitamin D deficiency is as follows: _Adults and Elderly:_ · Treatment dose: 4000 IU daily (1.33ml) for 10 weeks (280,000 IU in total). · Maintenance dose: 800-2000 IU daily (0.27ml-0.67ml) (occasionally up to 4000 IU daily may be required). _Adolescents (children >12 years)_ For treatment and maintenance · 500 - 2000 IU/day (equivalent to 0.17 ml – 0.67 ml per day). _Dosage in hepatic impairment:_ No dose adjustment is required. _Dose in renal impairment:_ Colecalciferol should not be used in patients with severe renal impairment (typically defined as a patient with eGFR of <30 ml/min/1.73m 2 , where the normal eGFR is typically >90 ml/min/1.73m 2 ). _Dose in pregnancy and lactation:_ H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Belgenin tamamını okuyun