Picato
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-03-2020
Charakterystyka produktu
(SPC)
04-03-2020
Sprawozdanie z oceny publicznego
(PAR)
04-03-2020
Składnik aktywny:
Ingenol mebutate
Dostępny od:
LEO Laboratories Ltd.
Kod ATC:
D06BX02
INN (International Nazwa):
ingenol mebutate
Grupa terapeutyczna:
Antibiotics and chemotherapeutics for dermatological use, Other chemotherapeutics
Dziedzina terapeutyczna:
Keratosis, Actinic
Wskazania:
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-11-15
Ulotka dla pacjenta
37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
PICATO 150 MICROGRAMS/GRAM GEL
ingenol mebutate
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 Picato is and what it is used for
2.
What you need to know before you use Picato
3.
How to use Picato
4.
Possible side effects
5.
How to store Picato
6.
Contents of the pack and other information
1.
WHAT PICATO IS AND WHAT IT IS USED FOR
Picato contains the active substance ingenol mebutate.
This medicine is used for topical (on the skin) treatment of actinic
keratosis, also called solar keratosis,
in adults. Actinic keratoses are rough areas of skin found in people
who have been exposed to too
much sunshine over the course of their lifetime. Picato 150
micrograms/gram gel is used for actinic
keratosis on the face and scalp.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PICATO
DO NOT USE PICATO
-
If you are allergic to ingenol mebutate or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Picato.
-
Do not get Picato in your eyes. Wash your hands thoroughly after you
have applied the gel.
Wash your hands again if you happen to touch the area where you
applied the gel. Take care not
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Charakterystyka produktu
1
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_ _
_ _
_ _
_ _
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_ _
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
Picato 150 micrograms/gram gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 150 mcg of ingenol mebutate. Each tube
contains 70 mcg of ingenol
mebutate in 0.47 g of gel.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
Clear colourless gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Picato is indicated for the cutaneous treatment of non-hyperkeratotic,
non-hypertrophic actinic
keratosis in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Actinic keratosis on the face and scalp in adults _
One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate)
should be applied once daily
to the affected area for 3 consecutive days.
Optimal therapeutic effect can be assessed approximately 8 weeks after
treatment.
A repeat treatment course of Picato can be given if an incomplete
response is seen at a follow-up
examination after 8 weeks or if lesions that are cleared at this
examination recur in subsequent
examinations.
_Paediatric population _
There is no relevant use of Picato in the paediatric population.
_Elderly population _
No dose adjustment is required (see section 5.1).
_Immunocompromised patients _
Clinical data on treatment in immunocompromised patients is not
available, but systemic risks are not
expected since ingenol mebutate is not absorbed systemically.
Method of administration
Medicinal product no longer authorised
3
The content of one tube covers a treatment area of 25 cm
2
(e.g. 5 cm x 5 cm). The tube is for single
use only and should be discarded after use (see section 6.6).
The gel from the tube should be squeezed onto a fingertip
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