Cystadane
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-06-2019
Produktets egenskaber
(SPC)
13-06-2019
Offentlige vurderingsrapport
(PAR)
06-01-2017
Aktiv bestanddel:
Betaine anhydrous
Tilgængelig fra:
Recordati Rare Diseases
ATC-kode:
A16AA06
INN (International Name):
betaine anhydrous
Terapeutisk gruppe:
Other alimentary tract and metabolism products,
Terapeutisk område:
Homocystinuria
Terapeutiske indikationer:
Adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (CBS);5,10-methylene-tetrahydrofolate reductase (MTHFR);cobalamin cofactor metabolism (cbl).Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Produkt oversigt:
Revision: 14
Autorisation status:
Authorised
Autorisation dato:
2007-02-14
Indlægsseddel
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CYSTADANE 1 G ORAL POWDER
Betaine anhydrous
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 your 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 Cystadane is and what it is used for
2.
What do you need to know before you take Cystadane
3.
How to take Cystadane
4.
Possible side effects
5
How to store Cystadane
6.
Contents of the pack and other information
1.
WHAT CYSTADANE IS AND WHAT IT IS USED FOR
Cystadane contains betaine anhydrous which is intended to be an
adjunctive treatment of
homocystinuria, an inherited (genetic) disease where the amino acid
methionine cannot be broken
down completely by the body.
Methionine is present in regular food protein (e.g. meat, fish, milk,
cheese, eggs). It is converted into
homocysteine which is then normally converted into cysteine during
digestion. Homocystinuria is a
disease caused by the accumulation of homocysteine which is not
converted to cysteine and is
characterised by formation of clots in the veins, bone weakness, and
skeletal and crystalline lens
abnormalities. The use of Cystadane together with other treatments
such as vitamin B6, vitamin B12,
folate and a specific diet aims to reduce the elevated homocysteine
levels in your body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYSTADANE
DO NOT TAKE CYSTADANE
If you are allergic to betaine anhydrous.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Cystadane.
If you notice side effects like headaches, vomiting or a change in
your vision and you are of the
h
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cystadane 1 g oral powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 g of powder contains 1 g of betaine anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White crystalline free flowing powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adjunctive treatment of homocystinuria, involving deficiencies or
defects in:
cystathionine beta-synthase (CBS),
5,10-methylene-tetrahydrofolate reductase (MTHFR),
cobalamin cofactor metabolism (cbl).
Cystadane should be used as supplement to other therapies such as
vitamin B6 (pyridoxine), vitamin
B12 (cobalamin), folate and a specific diet.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cystadane treatment should be supervised by a physician experienced in
the treatment of patients with
homocystinuria.
Posology
_Children and Adult _
The recommended total daily dose is 100 mg/kg/day given in 2 doses
daily. However, the dose should
be individually titrated according to plasma levels of homocysteine
and methionine. In some patients
doses above 200 mg/ kg/day were needed to reach therapeutic goals.
Caution should be exercised with
up-titrating doses for patients with CBS deficiency due to the risk
for hypermethioninaemia.
Methionine levels should be closely monitored in these patients.
_Special populations _
_Hepatic or renal impairment _
Experience with betaine anhydrous therapy in patients with renal
insufficiency or non-alcoholic
hepatic steatosis has demonstrated no need to adapt the dose regimen
of Cystadane.
Method of administration
The bottle should be lightly shaken before opening. Three measuring
spoons are provided which
dispense either 100 mg, 150 mg or 1 g of betaine anhydrous. It is
recommended that a heaped
measuring spoon is removed from the bottle and a flat surface e.g.
base of a knife is drawn across the
top of the measure. This will give the following doses: small measure
100 mg, middle size
measure 150 mg and large
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