Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Ingenol mebutate
LEO Laboratories Ltd.
D06BX02
ingenol mebutate
Antibiotics and chemotherapeutics for dermatological use, Other chemotherapeutics
Keratosis, Actinic
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.
Revision: 10
Withdrawn
2012-11-15
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 Pročitajte cijeli dokument
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 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 Pročitajte cijeli dokument