Klisyri

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

tirbanibulin

MAH:

Almirall, S.A.

ATC_code:

D06BX03

INN:

tirbanibulin

therapeutic_group:

Antibiotics and chemotherapeutics for dermatological use

therapeutic_area:

Keratosis, Actinic

therapeutic_indication:

Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

leaflet_short:

Revision: 1

authorization_status:

Authorised

authorization_date:

2021-07-16

PIL

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KLISYRI 10 MG/G OINTMENT
tirbanibulin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Klisyri is and what it is used for
2.
What you need to know before you use Klisyri
3.
How to use Klisyri
4.
Possible side effects
5.
How to store Klisyri
6.
Contents of the pack and other information
1.
WHAT KLISYRI IS AND WHAT IT IS USED FOR
Klisyri contains the active substance tirbanibulin. It is used for the
treatment of mild actinic keratosis
in adults. Actinic keratosis is a rough area of skin that has
developed in people who have been exposed
to too much sunshine over a long time. Klisyri should only be used for
flat actinic keratosis on the face
and scalp.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KLISYRI
DO NOT USE KLISYRI
•
if you are allergic to tirbanibulin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Klisyri
_ _
•
Do not use Klisyri until the area to be treated has healed from any
previous medicine, procedure
or surgical treatment. Do not apply Klisyri on open wounds or broken
skin.
•
Wash your hands if you happen to touch the area where you applied the
ointment.
•
Do not get Klisyri in your eyes. If it

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Klisyri
_ _
10 mg/g ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10 mg of tirbanibulin.
Each sachet contains 2.5 mg of tirbanibulin in 250 mg ointment.
Excipients with known effects:
Propylene glycol 890 mg/g ointment
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment.
White to off-white ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Klisyri is indicated for the field treatment of non-hyperkeratotic,
non-hypertrophic actinic keratosis
(Olsen grade 1) of the face or scalp in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Tirbanibulin ointment should be applied to the affected field on the
face or scalp once daily for one
treatment cycle of 5 consecutive days. A thin layer of ointment should
be applied to cover the
treatment field of up to 25cm
2
.
If a dose is missed, the patient should apply the ointment as soon as
he/she remembers and then he/she
should continue with the regular schedule. However, the ointment
should not be applied more than
once a day.
Tirbanibulin ointment should not be applied until the skin is healed
from treatment with any previous
medicinal product, procedure or surgical treatment and should not be
applied to open wounds or
broken skin (see section 4.4).
Therapeutic effect can be assessed approximately 8 weeks after
treatment starts. If the treated area
does not show complete clearance at the follow-up examination, about 8
weeks after the treatment
cycle started or thereafter, the treatment should be re-evaluated and
management re-considered.
No clinical data on treatment for more than 1 treatment course of 5
consecutive days are available (see
section 4.4). If recu