Ikervis

Основна информация

  • Търговско наименование:
  • Ikervis
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Ikervis
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Ophthalmologicals,
  • Терапевтична област:
  • Corneal Diseases
  • Терапевтични показания:
  • Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
  • Каталог на резюме:
  • Revision: 6

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002066
  • Дата Оторизация:
  • 19-03-2015
  • EMEA код:
  • EMEA/H/C/002066
  • Последна актуализация:
  • 04-04-2020

Доклад обществена оценка

EMA/56994/2015

EMEA/H/C/002066

EPAR summary for the public

Ikervis

ciclosporin

This is a summary of the European public assessment report (EPAR) for Ikervis. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Ikervis.

For practical information about using Ikervis, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Ikervis and what is it used for?

Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent

layer covering the front of the eye) in adult patients with dry eye disease. It is used when treatment

with artificial tears (tear substitutes) is insufficient to improve the condition.

Ikervis contains the active substance ciclosporin.

How is Ikervis used?

Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare

professional trained in ophthalmology (eye medicine).

The medicine is available as single-dose eye drops and the recommended dose is one drop in each

affected eye daily at bedtime. The doctor should confirm the need for continuing treatment at least

every 6 months. If other eye drops are used, the different medicines must be given at least 15 minutes

apart. Ikervis should be given last.

For further information, see the package leaflet.

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

How does Ikervis work?

In patients with dry eye disease, either not enough tear fluid is produced to create the protective film

of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry

out too quickly. Without sufficient protection from the tear fluid, the cornea can get damaged and

become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision.

The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body’s natural

defences) that are involved in the processes that cause inflammation. Applying it directly to the eye

reduces inflammation and damage there but limits its effects elsewhere in the body.

What benefits of Ikervis have been shown in studies?

The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye

disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any

active substance). The main measure of effectiveness was the proportion of patients whose condition

responded to treatment after six months, as measured by a combination of damage to the cornea and

a score for the level of symptoms, including discomfort and pain. About 29% (44 of 154) of those

given Ikervis responded, compared with 23% (21 of 91) given the vehicle. The proportion of patients

who responded to treatment was therefore similar in the two groups, but when only the damage to the

cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLA-

DR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with

the dummy treatment.

What are the risks associated with Ikervis?

The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and

irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia

(red eye), and erythema (redness) of the eyelid. These symptoms are usually short lasting and occur

at the time the eye drops are used. For the full list of all side effects reported with Ikervis, see the

package leaflet.

The medicine must not be used in patients who have or are suspected to have an infection of the eye

or the tissues around the eye. For the full list of restrictions, see the package leaflet.

Why is Ikervis approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis’s benefits

are greater than its risks and recommended that it be approved for use in the EU. Although Ikervis had

not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain,

there was evidence that it could reduce the inflammation and damage to the cornea associated with

keratitis. The CHMP considered that this was clinically meaningful, since none of the available

medicines for the condition have been shown to reduce damage to the surface of the eye, which might

help prevent the progression of the disease. Regarding safety, the medicine was well tolerated, with

mainly short-lasting effects on the eye at the time the eye drops are used; the risk of effects on the

body as a whole was considered to be low.

What measures are being taken to ensure the safe and effective use of

Ikervis?

A risk management plan has been developed to ensure that Ikervis is used as safely as possible. Based

on this plan, safety information has been included in the summary of product characteristics and the

Ikervis

EMA/56994/2015

Page 2/3

package leaflet for Ikervis, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Ikervis

The European Commission granted a marketing authorisation valid throughout the European Union for

Ikervis on 19 March 2015.

The full EPAR and risk management plan summary for Ikervis can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 04-2015.

Ikervis

EMA/56994/2015

Page 3/3

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

IKERVIS 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

What IKERVIS is and what it is used for

What you need to know before you use IKERVIS

How to use IKERVIS

Possible side effects

How to store IKERVIS

Contents of the pack and other information

1.

What IKERVIS is and what it is used for

IKERVIS contains the active substance, ciclosporin. Ciclosporin belongs to a group of medicines

known as immunosuppressive agents that are used to reduce inflammation.

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).

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.

2.

What you need to know before you use

IKERVIS

Do NOT use IKERVIS

if you are allergic to ciclosporin or 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 IKERVIS for dropping in your eye(s).

Talk to your doctor or pharmacist before using IKERVIS

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

Children and adolescents

IKERVIS should not be used in children and adolescents below 18 years old.

Other medicines and IKERVIS

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Talk to your doctor if you are using eye drops containing steroids with IKERVIS as these might

increase the risk of side effects.

IKERVIS eye drops should be used

at least 15 minutes

after any other eye drops are used.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before using this medicine.

IKERVIS

should not be used

if you are pregnant.

If you could become pregnant you must use contraception while using this medicine.

IKERVIS is likely to be present in breast milk in very small amounts. If you are breast feeding talk to

your doctor before using this medicine.

Driving and using machines

Your vision may be blurred immediately after using IKERVIS eye drops. If this happens, wait until

your vision clears before you drive or use machines.

IKERVIS contains cetalkonium chloride

This medicine contains 0.05 mg cetalkonium chloride in 1 mL. Cetalkonium chloride may be absorbed

by soft contact lenses and may change the colour of the contact lenses. You should remove contact

lenses before using this medicine and put them back 15 minutes afterwards. Cetalkonium chloride may

also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at

the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this

medicine, talk to your doctor.

3.

How to use IKERVIS

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose

is one drop in each affected eye, once daily at bedtime.

Instructions for use

Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not

understand.

Wash your hands.

If you wear contact lenses, take them out at bedtime before using the drops; you can reinsert

them when you wake up.

Open the aluminium pouch, which contains 5 single-dose containers.

Take one single-dose container from the aluminium pouch.

Gently shake the single dose container prior to use.

Twist off the cap

(picture 1)

Pull down your lower eyelid

(picture 2)

Tilt your head back and look up at the ceiling.

Gently squeeze one drop of the medicine onto your eye. Make sure you do not touch your eye

with the tip of the single-dose container.

Blink a few times so that the medicine covers your eye.

After using IKERVIS, press a finger into the corner of your eye by the nose and close gently

the eyelids for 2 minutes

(picture 3)

. This helps to stop IKERVIS getting into the rest of the

body.

If you use drops in both eyes, repeat the steps for your other eye.

Discard the single dose container as soon as you have used it, even if there is still some liquid

left in it.

The remaining single-dose containers should be kept in the aluminium pouch.

If a drop misses your eye, try again.

If you use more IKERVIS than you should

, rinse your eye with water. Do not put in any more drops

until it is time for your next regular dose.

If you forget to use IKERVIS

, continue with the next dose as planned. Do not use a double dose to

make up for the forgotten dose. Do not use more than one drop each day in the affected eye(s).

If you stop using IKERVIS

without speaking to your doctor, the inflammation of the transparent

front part of your eye (known as keratitis) will not be controlled and could lead to impaired vision.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

The most common side effects are in and around the eyes.

Very common

(may affect more than 1 in 10 people)

Eye pain,

Eye irritation

Common

(may affect up to 1 in 10 people)

Redness of the eyelid,

Watery eyes,

Eye redness,

Blurred vision,

Swelling of the eyelid,

Redness of the conjunctiva (thin membrane covering the front part of the eye),

Iching in the eye

Uncommon

(may affect up to 1 in 100 people)

Discomfort in or around the eye when the drops are put into the eye, including feeling that there

is something in the eye,

Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye),

Tear disorder,

Eye discharge,

Irritation or inflammation of the conjunctiva (thin membrane covering the front part of the eye),

Inflammation of the iris (coloured part of the eye) or eyelid,

Deposits in the eye,

Abrasion to the outer layer of the cornea,

Red or swollen eyelids,

Cyst in the eyelid,

Immune response or scarring in the cornea,

Itching in the eyelid,

Bacterial infection or inflammation of the cornea (transparent front part of the eye),

Painful rash around the eye caused by the herpes zoster virus,

Headache

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store IKERVIS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton, the aluminium pouch

and on the single-dose containers after “EXP”. The expiry date refers to the last day of that month.

Do not freeze.

After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in

order to protect from light and avoid evaporation. Discard any opened individual single-dose container

with any remaining emulsion immediately after use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What IKERVIS contains

The active substance is ciclosporin. One millilitre of IKERVIS contains 1 mg of ciclosporin.

The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol,

poloxamer 188, sodium hydroxide (for pH adjustment) and water for injections.

What IKERVIS looks like and contents of the pack

IKERVIS is a milky white eye drops emulsion.

It is supplied in single-dose containers made of a low-density polyethylene (LDPE).

Each single-dose container contains 0.3 mL eye drops, emulsion.

The single-dose containers are wrapped in a sealed aluminium pouch.

Pack sizes: 30 and 90 single-dose containers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

SANTEN Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer

EXCELVISION

Rue de la Lombardière

ZI la Lombardière

F-07100 Annonay

France

SANTEN Oy

Niittyhaankatu 20

33720 Tampere

Finland

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Santen Oy

Tél/Tel : +32 (0) 24019172

Lietuva

Santen Oy

Tel: +370 37 366628

България

Santen Oy

Teл.: +359 (0) 888 755 393

Luxembourg/Luxemburg

Santen Oy

Tél/Tel: +352 (0) 27862006

Česká republika

Santen Oy

Tel: +420 234 102 170

Magyarország

Santen Oy

Tel.: +36 (06) 16777305

Danmark

Santen Oy

Tlf: +45 78737843

Malta

Santen Oy

Tel: + 358 (0) 3 284 8111

Deutschland

Santen GmbH

Tel: +49 (0) 3030809610

Nederland

Santen Oy

Tel: +31 (0) 207139206

Eesti

Santen Oy

Tel: +372 5067559

Norge

Santen Oy

Tlf: +47 21939612

Ελλάδα

Santen Oy

Τηλ: + 358 (0) 3 284 8111

Österreich

Santen Oy

Tel: +43 (0) 720116199

España

Santen Pharmaceutical Spain S.L.

Tel: + 34 914 142 485

Polska

Santen Oy

Tel.: +48 (0) 221168608

France

Santen

Tél: +33 (0) 1 70 75 26 84

Portugal

Santen Oy

Tel: + 351 308 805 912

Hrvatska

Santen Oy

Tel: + 358 (0) 3 284 8111

România

Santen Oy

Tel: +40 (0) 316300603

Ireland

Santen Oy

Tel: + 353 (0) 16950008

Slovenija

Santen Oy

Tel: + 358 (0) 3 284 8111

Ísland

Santen Oy

Sími: + 358 (0) 3 284 8111

Slovenská republika

Santen Oy

Tel: +421 (01) 23 332 5519

Italia

Santen Italy S.r.l.

Tel: +39 0236009983

Suomi/Finland

Santen Oy

Puh/Tel: +358 (0) 974790211

Κύπρος

Santen Oy

Τηλ: + 358 (0) 3 284 8111

Sverige

Santen Oy

Tel: +46 (0) 850598833

Latvija

Santen Oy

Tel: +371 677 917 80

United Kingdom

Santen UK Limited

Tel: + 44 (0) 345 075 4863

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu