CYSTADROPS 3.8 MGML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MERCAPTAMINE AS HYDROCHLORIDE

متاح من:

MEDISON PHARMA LTD

ATC رمز:

A16AA04

الشكل الصيدلاني:

OPHTHALMIC SOLUTION

تركيب:

MERCAPTAMINE AS HYDROCHLORIDE 3.8 MG

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RECORDATI RARE DISEASES, FRANCE

المجال العلاجي:

MERCAPTAMINE

الخصائص العلاجية:

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

تاريخ الترخيص:

2020-05-20

نشرة المعلومات

Cystadrops-3.8mg_ml-PIL-ENG-D12-F
Patient leaflet in accordance with the Pharmacists Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Cystadrops 3.8 mg/ml
Eye drops
Active ingredient and quantity:
Each 1 ml contains 3.8 mg cysteamine (mercaptamine)
Inactive ingredients and allergens in the preparation - see section 6
‘Additional information’. See
also ‘Important information about some of this medicine’s
ingredients’ in section 2.
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?
Cystadrops is indicated for the treatment of corneal cystine crystal
deposits in adults and children
from 2 years of age with cystinosis.
Therapeutic group - eye preparations
Cystinosis is a rare hereditary disease in which the body is unable to
remove excess cystine
(an amino acid). This causes cystine crystals to accumulate in various
organs (such as
kidney and eyes). Accumulation of crystals in the eye can lead to
increased sensitivity to
light (photophobia), corneal deterioration (keratopathy) and loss of
vision.
2.
Before using the medicine
Do not use this medicine if:

you are sensitive (allergic) to the active ingredient (cysteamine) or
to any of the other
ingredients in this medicine (see section 6 - “Additional
information”).
Special warnings about using this medicine
Contact lenses - Contact of the medicine with contact lenses should be
avoided. You should
remove contact lenses before using this medicine and put them back 15
minutes afterwards.
Children and adolescents
Cystadrops may be used in children from 2 years of age at the same
dose as in adults.
Drug interactions
If you are taking, have recently taken or

خصائص المنتج

_ _
1
1.
NAME OF THE MEDICINAL PRODUCT
CYSTADROPS
3.8
MG/ML
eye drops solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg
mercaptamine (cysteamine).
Excipient with known effect:
Each mL of eye drops solution contains 0.1 mg of benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Eye drops solution.
Viscous, clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cystadrops is indicated for the treatment of corneal cystine crystal
deposits in adults and children from
2 years of age with cystinosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Cystadrops should be initiated under the supervision of
a physician experienced in the
management of cystinosis.
Posology
The recommended dose is one drop in each eye, 4 times a day during
waking hours. The
recommended interval between each instillation is 4 hours. The dose
could be decreased progressively
(to a minimum total daily dose of 1 drop in each eye) depending on the
results of ophthalmic
examination (such as, corneal cystine crystal deposits, photophobia).
If the patient misses an instillation, the patient should be told to
continue the treatment with the next
instillation.
The dose should not exceed 4 drops a day in each eye.
The accumulation of corneal cystine crystals increases if Cystadrops
is discontinued. The treatment
should not be stopped.
_Paediatric population _
Cystadrops may be used in paediatric patients from 2 years of age at
the same dose as in adults (see
section 5.1).
The safety and efficacy of Cystadrops in children aged less than 2
years has not been established. No
data are available.
2
Method of administration
For ocular use.
Before the first admnistration, in order to facilitate the
administration, the patient should be told to
bring back Cystadrops at room temperature. After first opening, the
patient should be told to keep the
dropper bottle at room temperature.
To avoid sticky eyes in the morning, the patient s