VEDROP Oral solution Ref.[9886] Active ingredients: Tocofersolan

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.

To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50. The result is the volume of Vedrop in ml:

Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg) / 50

The following table gives the volume of oral solution in function of patients' weights.

Special populations

Hepatic or renal impairment

Experience with tocofersolan therapy in patients with renal impairment or underlying liver impairment has demonstrated no need to adapt the dose regimen of Vedrop (see section 4.4).

Method of administration

Vedrop is administered orally with or without water. The 1-ml or 2-ml oral syringes included in the container are designed to assist in measuring out the exact dose in accordance with the prescribed posology.

Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.

In case of overdose, a symptomatic treatment should be proposed.

2 years.

After first opening the bottle: 1 month.

This medicinal product does not require any special storage conditions.

Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal. Oral syringes with housing of LDPE and piston of polystyrol. Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.

Boxes containing:

• one 10 ml bottle and one 1 ml oral syringe
• one 20 ml bottle and one 1 ml oral syringe
• one 60 ml and one 2 ml oral syringe

Not all pack sizes may be marketed.

Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack.

The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml. One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan.

The 2 ml oral syringe is graduated from 0.1 to 2 ml in steps of 0.1 ml. One graduation of the 2-ml oral syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan.