Cystagon
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
05-11-2021
Charakterystyka produktu
(SPC)
05-11-2021
Sprawozdanie z oceny publicznego
(PAR)
18-06-2015
Składnik aktywny:
mercaptamine bitartrate
Dostępny od:
Recordati Rare Diseases
Kod ATC:
A16AA04
INN (International Nazwa):
mercaptamine bitartrate
Grupa terapeutyczna:
Other alimentary tract and metabolism products,
Dziedzina terapeutyczna:
Cystinosis
Wskazania:
Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Authorised
Data autoryzacji:
1997-06-23
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYSTAGON 50 MG HARD CAPSULES
CYSTAGON 150 MG HARD CAPSULES
Cysteamine bitartrate (mercaptamine bitartrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What CYSTAGON is and what it is used for
2.
Before you use CYSTAGON
3.
How to use CYSTAGON
4.
Possible side effects
5.
How to store CYSTAGON
6.
Further information
1.
WHAT CYSTAGON IS AND WHAT IT IS USED FOR
Cystinosis is a metabolic disease called ‘nephropathic cystinosis’
which is characterized by an
abnormal accumulation of the amino acid cystine in various organs of
the body such as the kidney,
eye, muscle, pancreas, and brain. Cystine build up causes kidney
damage and excretion of excess
amounts of glucose, proteins and electrolytes. Different organs are
affected at different ages.
CYSTAGON is prescribed to manage this rare inherited disorder.
CYSTAGON is a medicine that
reacts with cystine to decrease its level within the cells.
2.
BEFORE YOU USE CYSTAGON
DO NOT USE CYSTAGON
-
if you -or your child- are allergic (hypersensitive) to cysteamine
bitartrate or penicillamine or
any of the other ingredients of Cystagon.
-
If you are pregnant, this is particularly relevant during the first
trimester
-
if you are breast-feeding.
TAKE SPECIAL CARE WITH CYSTAGON
-
When your or your child’s disorder has been confirmed by leucocyte
cystine measurements, the
therapy with CYSTAGON must be started as soon as possible.
_ _
-
A few cases of skin lesions on elbows like little hard lumps have been
reported in children
treated with high doses of different
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CYSTAGON 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of cysteamine (as mercaptamine
bitartrate) .
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard Capsule
White, opaque hard capsules with CYSTA 50 on the body and RECORDATI
RARE DISEASES on
the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
CYSTAGON is indicated for the treatment of proven nephropathic
cystinosis. Cysteamine reduces
cystine accumulation in some cells (e.g. leukocytes, muscle and liver
cells) of nephropathic cystinosis
patients and, when treatment is started early, it delays the
development of renal failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CYSTAGON treatment should be initiated under the supervision of a
physician experienced in the
treatment of cystinosis.
The goal of therapy is to keep leucocyte cystine levels below 1 nmol
hemicystine/mg protein. White
blood cell (WBC) cystine levels should therefore be monitored to
adjust the dose. The WBC levels
should be measured 5 to 6 hours after dosing and should be checked
frequently when initiating therapy
(e.g. monthly) and every 3-4 months when on a stable dose.
•
_For children up to age 12 years,_
CYSTAGON dosing should be on the basis of body surface
area (g/m
2
/day). The recommended dose is 1.30 g/m
2
/day of the free base divided four times
daily.
•
_For patients over age 12_
_and over 50 kg weight,_
the recommended CYSTAGON dose is
2 g/day, divided four times daily.
Starting doses should be 1/4 to 1/6 of the expected maintenance dose,
increased gradually over 4-
6 weeks to avoid intolerance. The dose should be raised if there is
adequate tolerance and the
leucocyte cystine level remains >1 nmol hemicystine/mg protein. The
maximum dose of CYSTAGON
used in clinical trials was 1.95 g/m
2
/day.
The use of doses higher than 1.95 g/m
2
/day is not recommended (see section 4.4).
Digestive tolerance of cysteamine is improved
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