Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tocofersolan
Recordati Rare Diseases
A11HA08
tocofersolan
Vitamins
Cholestasis; Vitamin E Deficiency
Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
Revision: 13
Authorised
2009-07-23
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE USER VEDROP 50 MG/ML ORAL SOLUTION Tocofersolan This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. WHAT IS IN THIS LEAFLET 1. What Vedrop is and what it is used for 2. What you need to know before you take Vedrop 3. How to take Vedrop 4. Possible side effects 5. How to store Vedrop 6. Contents of the pack and other information 1. WHAT VEDROP IS AND WHAT IT IS USED FOR Vedrop contains vitamin E (in the form of tocofersolan). It is used to treat lack of vitamin E due to digestive malabsorption (where nutrients from the food are not easily absorbed during digestion) in patients from birth (full term newborns) up to 18 years of age suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEDROP DO NOT TAKE VEDROP - If you are allergic to vitamin E (d-alpha-tocopherol) or any of the other ingredients of this medicine (listed in section 6). - Vedrop must not be used in newborn premature babies. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Vedrop if you have: Problems with your kidney or dehydration. Vedrop should be used with caution and your kidney function closely monitored, because polyethylene glycol, part of the active Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol. Excipients: Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Slightly viscous, pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment with Vedrop should be initiated and supervised by a physician experienced in the management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis. Bioavailability of vitamin E from Vedrop differs from that of other medicinal products. The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan. Plasma vitamin E level should be monitored monthly for at least the first few months of therapy, thereafter at regular intervals and the dose adjusted accordingly if necessary. Posology The recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of d-alpha-tocopherol in the form of tocofersolan). The dose should be prescribed in ml. The dose should be adjusted according to plasma vitamin E level. 3 To calculate the dose of Vedrop to be adm Прочетете целия документ