Verkazia

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

ciclosporin

Saatavilla:

Santen Oy

ATC-koodi:

S01XA18

INN (Kansainvälinen yleisnimi):

ciclosporin

Terapeuttinen ryhmä:

Ophthalmologicals

Terapeuttinen alue:

Conjunctivitis; Keratitis

Käyttöaiheet:

Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-07-06

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VERKAZIA 1 MG/ML EYE DROPS, EMULSION
ciclosporin
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 Verkazia is and what it is used for
2.
What you need to know before you use Verkazia
3.
How to use Verkazia
4.
Possible side effects
5.
How to store Verkazia
6.
Contents of the pack and other information
1.
WHAT VERKAZIA IS AND WHAT IT IS USED FOR
Verkazia contains the active ingredient, ciclosporin. Ciclosporin
reduces the activity of the body’s
immune (defence) system and in this way it reduces inflammation (body
response to harmful stimuli).
Verkazia is used to treat children and adolescents aged 4 to 18 years
with severe vernal
keratoconjunctivitis (an allergic condition of the eye that occurs
more frequently in spring and affects
the transparent layer in the front part of the eye and the thin
membrane covering the front part of the
eye).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VERKAZIA
DO NOT USE VERKAZIA
-
if you are allergic to ciclosporin or to any of the other ingredients
of this medicine (listed in
section 6).
-
if you have had or have a cancer in or around your eye.
-
if you have an eye infection.
WARNINGS AND PRECAUTIONS
Only use Verkazia in your eye as described under section 3. Do not
exceed the treatment period
prescribed by your doctor.
Talk to your doctor or pharmacist before using Verkazia:
-
if you have had an eye infection or if you suspect you have an eye
infection.
-
if you have any other kind of eye disease.

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Verkazia 1 mg/mL eye drops, emulsion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of emulsion contains 1 mg of ciclosporin.
Excipient with known effect
One mL of emulsion contains 0.05 mg cetalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, emulsion.
Milky white emulsion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Treatment of severe vernal keratoconjunctivitis (VKC) in children from
4 years of age and
adolescents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Verkazia treatment should only be initiated by an ophthalmologist or a
healthcare professional
qualified in ophthalmology.
Posology
_Children from 4 years of age and adolescents _
The recommended dose is one drop of Verkazia 4 times a day (morning,
noon, afternoon and evening)
to be applied to each affected eye during the VKC season. If signs and
symptoms of VKC persist after
the end of the season, the treatment can be maintained at the
recommended dose or decreased to one
drop twice daily once adequate control of signs and symptoms is
achieved. Treatment should be
discontinued after signs and symptoms are resolved, and reinitiated
upon their recurrence.
_Missed dose _
If a dose is missed, treatment should be continued on the next
instillation as normal. Patients should be
advised not to instill more than one drop for each instillation in the
affected eye(s).
_Paediatric population _
There is no relevant use of Verkazia in children below 4 years in the
treatment of severe vernal
keratoconjunctivitis.
_ _
_ _
3
_Patients with renal or hepatic impairment _
The effect of Verkazia has not been studied in patients with renal or
hepatic impairment. However, no
special dose adjustment is needed in these populations.
Method of administration
Ocular use
_Precautions to be taken before administering the medicinal product _
Patients should be instructed to first wash their hands.
Prior to administration, the single-dose contain