Staquis

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

Crisaborole

Disponível em:

Pfizer Europe MA EEIG 

Código ATC:

D11AH06

DCI (Denominação Comum Internacional):

crisaborole

Grupo terapêutico:

Other dermatological preparations

Área terapêutica:

Dermatitis, Atopic

Indicações terapêuticas:

Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤ 40% body surface area (BSA) affected.

Resumo do produto:

Revision: 6

Status de autorização:

Withdrawn

Data de autorização:

2020-03-27

Folheto informativo - Bula

24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STAQUIS 20 MG/G OINTMENT
crisaborole
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, pharmacist, or
nurse.
-
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, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Staquis is and what it is used for
2.
What you need to know before you use Staquis
3.
How to use Staquis
4.
Possible side effects
5.
How to store Staquis
6.
Contents of the pack and other information
1.
WHAT STAQUIS IS AND WHAT IT IS USED FOR
Staquis contains the active substance crisaborole. Staquis is used on
the skin to control the symptoms
of mild to moderate atopic dermatitis in adults and children from 2
years of age. Atopic dermatitis,
also called atopic eczema, causes skin inflammation, redness,
itchiness, dryness, and thickening in
people prone to allergies. The ointment should not be used on more
than 40% of your body surface
area.
Crisaborole, the active substance in Staquis, is thought to work by
reducing inflammation and some
effects of the immune system (the body’s defences).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STAQUIS
DO NOT USE STAQUIS
-
if you are allergic to crisaborole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Staquis.
Staquis is not for use

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
Staquis 20 mg/g ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One g of ointment contains 20 mg of crisaborole.
Excipients with known effect
Propylene glycol, 90 mg/g of 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
Staquis is indicated for treatment of mild to moderate atopic
dermatitis in adults and paediatric
patients from 2 years of age with ≤ 40% body surface area (BSA)
affected.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_ _
A layer of ointment is to be applied twice daily to affected areas.
The ointment should only be applied to affected skin areas up to a
maximum of 40% BSA.
The ointment can be used on all skin areas except on the scalp. Use on
the scalp has not been studied.
The ointment can be used twice daily for up to 4 weeks per treatment
course. If any signs and/or
symptoms persist, or new areas affected with atopic dermatitis appear,
further treatment course(s) can
be used as long as the application does not exceed 40% BSA (see
section 5.1).
Use of the ointment should be discontinued if signs and/or symptoms on
treated areas persist after 3
consecutive treatment courses of 4 weeks each or if the signs and/or
symptoms worsen during
treatment.
Medicinal product no longer authorised
3
_Paediatric population _
For children and adolescents (2-17 years) the posology is the same as
for adults.
The safety and efficacy of Staquis in children less than 2 years of
age has not been established. No
data are available.
_Special populations _
_Hepatic impairment _
Clinical studies in subjects wit