Procysbi
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
26-05-2023
Produktets egenskaber
(SPC)
26-05-2023
Offentlige vurderingsrapport
(PAR)
03-10-2013
Aktiv bestanddel:
mercaptamine bitartrate
Tilgængelig fra:
Chiesi Farmaceutici S.p.A
ATC-kode:
A16AA04
INN (International Name):
mercaptamine
Terapeutisk gruppe:
Other alimentary tract and metabolism products,
Terapeutisk område:
Cystinosis
Terapeutiske indikationer:
Procysbi 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.
Produkt oversigt:
Revision: 16
Autorisation status:
Authorised
Autorisation dato:
2013-09-05
Indlægsseddel
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROCYSBI 25 MG GASTRO-RESISTANT HARD CAPSULES
PROCYSBI 75 MG GASTRO-RESISTANT HARD CAPSULES
cysteamine (mercaptamine bitartrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have 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 PROCYSBI is and what it is used for
2.
What you need to know before you take PROCYSBI
3.
How to take PROCYSBI
4.
Possible side effects
5.
How to store PROCYSBI
6.
Contents of the pack and other information
1.
WHAT PROCYSBI IS AND WHAT IT IS USED FOR
PROCYSBI contains the active substance cysteamine (also known as
mercaptamine) and is taken for
the treatment of nephropathic cystinosis in children and adults.
Cystinosis is a disease affecting how
the body functions, with 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.
PROCYSBI is a medicine that reacts with cystine to decrease its level
within the cells. Cysteamine
therapy should be initiated promptly after confirmation of the
diagnosis of cystinosis to achieve
maximum benefit.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCYSBI
DO NOT TAKE PROCYSBI
−
If you are allergic to cysteamine (also known as mercaptamine) or any
of the other ingredients
of this medicine (listed in section 6).
−
If you are allergic to penicillamine (this is not “penicillin”,
but a medicine us
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
PROCYSBI 25 mg gastro-resistant hard capsules
PROCYSBI 75 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROCYSBI 25 mg gastro-resistant hard capsule
Each gastro-resistant hard capsule contains 25 mg of cysteamine (as
mercaptamine bitartrate).
PROCYSBI 75 mg gastro-resistant hard capsule
Each gastro-resistant hard capsule contains 75 mg of cysteamine (as
mercaptamine bitartrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule.
PROCYSBI 25 mg
gastro-resistant hard capsule
Light blue size 3 (15.9 x 5.8 mm) hard capsules imprinted “25 mg”
in white ink and a light blue cap
imprinted with “PRO” in white ink.
PROCYSBI 75 mg gastro-resistant hard capsule
Light blue size 0 (21.7 x 7.6 mm) hard capsules imprinted “75 mg”
in white ink and a dark blue cap
imprinted with “PRO” in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROCYSBI
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
PROCYSBI treatment should be initiated under the supervision of a
physician experienced in the
treatment of cystinosis.
Cysteamine
therapy must be initiated promptly once the diagnosis is confirmed
(i.e., increased WBC
cystine) to achieve maximum benefit.
Posology
White blood cell (WBC) cystine concentration may for instance be
measured by a number of different
techniques such as specific WBC subsets (e.g., granulocyte assay) or
the mixed leukocyte assay with
each assay having different target values. Healthcare professionals
should refer to the assay-specific
therapeutic targets provided by individual testing laboratories when
making decisions regarding
diagnosis and PROCYSBI dosing
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