Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tocofersolan
Orphan Europe (UK
A11HA08
Tocofersolan
50mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060500
OBJECT 1 VEDROP Summary of Product Characteristics Updated 17-Nov-2017 | Orphan Europe (UK) Limited 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 Baca dokumen lengkapnya