Vedrop
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-08-2019
Charakterystyka produktu
(SPC)
22-08-2019
Sprawozdanie z oceny publicznego
(PAR)
21-09-2017
Składnik aktywny:
tocofersolan
Dostępny od:
Recordati Rare Diseases
Kod ATC:
A11HA08
INN (International Nazwa):
tocofersolan
Grupa terapeutyczna:
Vitamins
Dziedzina terapeutyczna:
Cholestasis; Vitamin E Deficiency
Wskazania:
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.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Authorised
Data autoryzacji:
2009-07-23
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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