PICATO Gel (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Picato 150 micrograms/gram gel.
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.
Pharmaceutical form
Gel. Clear colourless gel.
Therapeutic indications
Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
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. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Eye exposure Contact with the eyes can cause chemical conjunctivitis and corneal burns. Patients should wash their hands thoroughly after applying the gel and following any contact with the treated area, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Interactions with systemically absorbed medicinal products are considered unlikely as Picato is not absorbed systemically.
Pregnancy and lactation
Pregnancy There are no data from the use of ingenol mebutate in pregnant women. Animal studies showed slight embryo-fetal toxicity (see section 5.3). Risks to humans receiving cutaneous treatment with ...
Effects on ability to drive and use machines
Picato has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions are local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration ...
Overdose
Overdosing of Picato could result in an increased incidence of local skin responses. Management of overdose should consist of treatment of clinical symptoms.
Pharmacodynamic properties
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, other chemotherapeutics ATC code: D06BX02 Mechanism of action The mechanism of action of ingenol mebutate for use in ...
Pharmacokinetic properties
The systemic pharmacokinetic profile of ingenol mebutate and its metabolites has not been characterised in humans due to the absence of quantifiable whole blood levels following cutaneous administration. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity. The non-clinical safety studies demonstrate that cutaneous ...
List of excipients
Isopropyl alcohol Hydroxyethylcellulose Citric acid monohydrate Sodium citrate Benzyl alcohol Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2ºC-8ºC). Tubes should be discarded after first opening.
Nature and contents of container
Single-dose laminate tubes with inner layer of High Density Polyethylene (HDPE) and aluminium as the barrier layer. Caps of HDPE. Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
LEO Laboratories Ltd., 285 Cashel Road, Crumlin, Dublin 12, Ireland
Marketing authorization number(s)
EU/1/12/796/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
