Ikervis 1mgmL eye drops emulsion

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CICLOSPORIN

Boleh didapati daripada:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

CICLOSPORIN

Unit dalam pakej:

90 Units; 30 Units; 30 Units; 90 Units

Dikeluarkan oleh:

EXCELVISION

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IKERVIS
®
1MG/ML EYE DROPS, EMULSION
Ciclosporin A (1mg/ml)
WHAT IS IN THIS LEAFLET
1.
What Ikervis is used for
2.
How Ikervis works
3.
Before you use Ikervis
4.
How to use Ikervis
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ikervis
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IKERVIS IS USED FOR
Ikervis is used to treat adults with severe
keratitis (inflammation of the cornea, the
transparent layer in the front part of the
eye). It is used in those patients who
have
dry
eye
disease,
which
has
not
improved
despite
treatment
with
tear
substitutes (artificial tears).
Ikervis is also used to treat severe vernal
keratoconjunctivitis (VKC) in children
from
4
years
of
age
through
adolescence.
Talk to a doctor if you do not feel better
or if you feel worse.
You
should
visit
your
doctor
at
least
every 6 months to assess the effect of
Ikervis
HOW IKERVIS WORKS
Ikervis
contains
the
active
ingredient
ciclosporin.
Ciclosporin
belongs
to
a
group
of
medicines
known
as
immunosuppressive
agents.
These
medicines
are
used
to
reduce
inflammation.
BEFORE YOU USE IKERVIS
-
_When you must not use it_
Do NOT use Ikervis:
•
If you are allergic to ciclosporin
or
to any of the other
ingredients of this
medicine
(listed
in
section
“Ingredients”)
•
If you have an eye infection.
-
_Before you start to use it_
Talk to your doctor or pharmacist before
using Ikervis
FOR TREATMENT OF SEVERE KERATITIS IN
DRY EYE DISEASE
•
If you have previously had an eye
infection by the herpes virus that
might have damaged the transparent
front part of the eye (cornea)
•
If
you
are
taking
any
medicines
containing steroids
•
If you are taking any medicines to
treat glaucoma
Contact lenses can further damage the
transparent front part of the eye (cornea).
Therefore,
you
should
remove
your
contact lenses at bedtime before using
Ikervis; you can reinsert them when you
wake up
FOR TREATMENT OF SEVERE VKC
•
If you had an eye

Ciri produk

23363400
1. NAM E OF THE M EDI CIN AL PROD UCT
IKER VIS ®
2. QUALIT ATIVE A ND QUANTI TA TIVE
COMPOSITION
Excipient with kno wn effect:
chloride  (see section  4.4). For the full list of excipients, 
see section 6.1.
3. PRODUCT DESCRIPTION
IKER VIS ®  1 m g/m l,   eye  drops,  emuls ion is  a  ster ile, 
p re serv ativ e-free, positiv ely-char ged, oil  in   water 
emu ls ion  drug  product  th at  contains  the drug 
substan ce Ciclospor in at  a concentration  of 1mg/m l. 
T he emulsion  is milky -white in appear an ce.
4. CLINICAL P ARTICULARS
4.1 Therapeutic indication
Treatm ent of se ve re  keratitis  in adult  patients  with 
d ry  eye  diseas e,  w hich  has not impr oved  despit e 
tr eatment with tear substitutes (see section 5.1).
4.2 Posol ogy and method of ad ministrati on
IKE RVIS ® t reatm en t m ust  be  in itiated  by an  oph th alm ologis t 
or  a h ealth care p rofes sional  qualied  in  oph th alm ology .
Posology
Adults
The r ecommended  dose is one  drop  of IKER VIS
® once 
daily to be applied to the af fected eye(s) at bedtime.
Response  to treatment  should be reassessed  at least 
If a dose  is missed,  treatment  should be continued  on 
the  next  day as normal.  Patients  should be advised  not 
to instil mor e than one dr op in the affected eye(s).
Elderly patients
The  elderly  population  has been  studied  in clinical 
studies. No dose adjustment is r equired.
Patients with r enal or hepatic impair ment
The  effect  of IKER VIS
® has  not been  studied  in patients 
with  hepatic  or renal  impairment.  However, no  special 
considerations ar e needed in these populations.
Paediatric population
Ther e is  no  relevant  use of IKER VIS ® in  childr en and 
keratitis  in adult  patients  with dry eye  disease,  which has 
not impr oved despite tr eatment with tear substitutes.
Me