Cystadrops
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-10-2021
Valmisteyhteenveto
(SPC)
18-10-2021
Julkisesta arviointikertomuksesta
(PAR)
22-02-2017
Aktiivinen ainesosa:
mercaptamine hydrochloride
Saatavilla:
Recordati Rare Diseases
ATC-koodi:
S01XA21
INN (Kansainvälinen yleisnimi):
mercaptamine
Terapeuttinen ryhmä:
Ophthalmologicals
Terapeuttinen alue:
Cystinosis
Käyttöaiheet:
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-01-18
Pakkausseloste
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CYSTADROPS 3.8 MG/ML EYE DROPS SOLUTION
cysteamine (mercaptamine)
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 any 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 Cystadrops is and what it is used for
2.
What you need to know before you use Cystadrops
3.
How to use Cystadrops
4.
Possible side effects
5.
How to store Cystadrops
6.
Contents of the pack and other information
1.
WHAT CYSTADROPS IS AND WHAT IT IS USED FOR
WHAT CYSTADROPS IS
Cystadrops is an eye drops solution that contains the active substance
cysteamine (also known as
mercaptamine).
WHAT IT IS USED FOR
It is used to reduce the quantity of cystine crystals in the surface
of the eye (cornea) in adults and
children from 2 years of age with cystinosis.
WHAT IS CYSTINOSIS
Cystinosis is a rare hereditary disease in which the body is unable to
remove excess cystine (an amino
acid), causing 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE CYSTADROPS
DO NOT USE CYSTADROPS
If you are allergic to cysteamine or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Cystadrops.
OTHER MEDICINES AND CYSTADROPS
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
PREGNANCY AND BREAS
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Valmisteyhteenveto
_ _
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
Method of administration
For ocular use.
3
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.
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