Procysbi 75mg gastro-resistant capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Mercaptamine bitartrate

Mevcut itibaren:

Chiesi Ltd

ATC kodu:

A16AA04

INN (International Adı):

Mercaptamine bitartrate

Doz:

75mg

Farmasötik formu:

Gastro-resistant capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF:

Bilgilendirme broşürü

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.
−
If you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your d

Ürün özellikleri

OBJECT 1
PROCYSBI 75 MG GASTRO-RESISTANT HARD CAPSULES
Summary of Product Characteristics Updated 05-Jun-2018 | Chiesi
Limited
1. Name of the medicinal product
PROCYSBI 75 mg gastro-resistant hard capsules
2. Qualitative and quantitative composition
Each 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.
Light blue size 0 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.
Posology
The assay-dependent therapeutic goal is to maintain a white blood cell
(WBC) cystine level < 1 nmol
hemicystine/mg protein, 30 min after dosing, by adjusting the dose.
For patients adherent to a stable dose
of PROCYSBI, and who do not have easy access to an adequate facility
for measuring their WBC cystine,
the goal of therapy should be to maintain plasma cysteamine
concentration > 0.1 mg/L, 30 min after
dosing.
_Transferring patients from immediate-release cysteamine bitartrate
hard capsules _
Patients with cystinosis taking immediate-release cysteamine
bitartrate may be transferred to a total daily
dose of PROCYSBI equal to their previous total daily dose of
immediate-release cysteamine bitartrate.
Patients being transferred from immediate-release cysteamine
bitartrate to PROCYSBI should have their
WBC cystine levels measured in 2 weeks, and thereafter every 3 months
to assess optimal dosage as
described above.
Measurement timing: The determination of WBC cystine