CYSTADANE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BETAINE ANHYDROUS

متاح من:

MEDISON PHARMA LTD

ATC رمز:

A16AA06

الشكل الصيدلاني:

POWDER FOR SOLUTION

تركيب:

BETAINE ANHYDROUS 1 G/G

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RECORDATI RARE DISEASES, FRANCE

المجال العلاجي:

BETAINE

الخصائص العلاجية:

Treatment of homocystinuria.

تاريخ الترخيص:

2023-07-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
The dispensing of this medicine requires a doctor’s prescription
CYSTADANE
POWDER FOR PREPARING AN ORAL SOLUTION
Active ingredient and quantity:
Betaine anhydrous 1 g /g.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have further questions, refer
to 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?
Treatment of homocystinuria.
Homocystinuria is an inherited (genetic) disease where the amino acid
methionine cannot be
broken down completely in the body.
Methionine is present in regular food protein (such as meat, fish,
milk, cheese, eggs). It is
converted
into
homocysteine,
which
is
then
converted
into
cysteine
during
digestion.
Homocystinuria is a disease caused by accumulation of homocysteine
which is not converted
into cysteine, and is characterized by formation of venous blood
clots, bone weakness, skeleton
defects, and crystals on the eye lens.
The purpose of using Cystadane, together with other treatments, such
as vitamin B6, vitamin
B12, folic acid and a specific diet, is to reduce the elevated
homocysteine levels in the body.
THERAPEUTIC GROUP: Amino acid derivatives.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to betaine.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE

If you notice side effects like headaches, vomiting, or a change in
your vision and you have
a type of homocystinuria called CBS (cystathionine beta-synthase
deficiency), contact the
doctor immediately. This may be a sign of swelling in the brain
(cerebral edema). In that
case, your doctor will monitor the methionine level in your body and
review your diet. Your
treatment with Cystadane may need to be discontinued.

If you are being treated w

خصائص المنتج

רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ
10.16
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
Treatment of homocystinuria
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
_Adult _
The recommended total daily dose in adult is 6 g per day administered
orally in divided doses
of 3 g two times per day.
_ _
_Paediatric population _
The recommended total daily dose in paediatric patients over 10 years
of age is the same as
adult. However, dose titration may be preferable in paediatric
patients.
In paediatric patients less than 10 years of age, the usual effective
dose regimen is 100
mg/kg/day given in 2 doses daily; increasing the frequency above twice
daily and/or the dose
above 150 mg/kg/day does not improve the homocysteine-lowering effect.
_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.Measuring spoons
are provided which
dispense 1 g of betaine anhydrous. It is recommended that a heaped
measuring spoon is
removed from the container and a flat surface e.g. base of a knife is
drawn across the top of
the measure. This will give 1 g of betaine anhydrous.
The powder should be mixed with water, juice, milk, formula or food
until completely
dissolved and ingested immediatel