CYSTAGON 50 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

CYSTEAMINE AS BITARTRATE

Dostupné z:

MEDISON PHARMA LTD

ATC kód:

A16AA04

Forma lieku:

HARD CAPSULE

Zloženie:

CYSTEAMINE AS BITARTRATE 50 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

RECORDATI RARE DISEASES, FRANCE

Terapeutické oblasti:

MERCAPTAMINE

Terapeutické indikácie:

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.

Dátum Autorizácia:

2019-06-30

Príbalový leták

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
CYSTAGON 50 MG, 150 MG
HARD CAPSULES
NAME AND QUANTITY OF ACTIVE INGREDIENT:
CYSTAGON - Each hard capsule contains cysteamine (as cysteamine
bitartrate) 50mg,
150mg
_ _
* Inactive ingredients and allergens: see section 6 of this leaflet
(‘Additional
information’).
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Cystagon is intended for treating patients who have been diagnosed
with
nephropathic cystinosis.
The medicine reduces the buildup of cystine in several types of cells
(such as
white blood cells, muscle and liver cells) in nephropathic cystinosis
patients, and
when treatment is started early, the medicine postpones development of
kidney
failure.
THERAPEUTIC GROUP: medicines for treating metabolic diseases.
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 buildup causes kidney damage and excretion of excess amounts
of
glucose, proteins and electrolytes. Different organs are affected at
different ages.
2. BEFORE USING THIS MEDICINE
X DO NOT USE THIS MEDICINE IF:
•
you or your child are sensitive (allergic) to the active substance
cysteamine bitartrate, penicillamine, or any of the other ingredients
of
Cystagon (see section 6 ‘Additional information’).
•
you are pregnant, particularly during the first trimester.
•
you are breastfeeding.
2
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
When your or your chi

Súhrn charakteristických

PHYSICIAN'S PRESCRIBING INFORMATION
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 cysteamine
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 when the medici