Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Qutenza 179mg cutaneous patch (2012)

Εκδότης

Εκδότης Astellas Pharma Ltd
Διεύθυνση 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Qutenza 179 mg cutaneous patch.

Qualitative and quantitative composition

Each 280 cm2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per ...

Pharmaceutical form

Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the ...

Therapeutic indications

Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone ...

Posology and method of administration

Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies with other medicinal products have been performed as only transient low ...

Pregnancy and lactation

No clinical data on exposed pregnancies are available. Studies in animals have not shown teratogenic ...

Effects on ability to drive and use machines

No studies on the effects of Qutenza on the ability to drive and use machines have been performed. However, ...

Undesirable effects

Of the 1,327 patients treated with Qutenza in randomized controlled trials, 883 (67%) reported adverse ...

Overdose

No case of overdose has been reported. Qutenza is required to be administered by a physician or under ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other local anaesthetics ATC code: N01BX04 Mechanism of action Capsaicin, ...

Pharmacokinetic properties

The capsaicin contained in Qutenza is intended for delivery into the skin. In vitro data (active substance ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Patch Matrix: Silicone adhesives Diethylene glycol monoethyl ether Silicone oil Ethylcellulose N50 (E462) ...

Incompatibilities

Not applicable.

Shelf life

Unopened sachet: 4 years After opening sachet: apply Qutenza within 2 hours

Special precautions for storage

Qutenza cutaneous patch: Store flat in the original sachet and carton. Store below 25°C. Cleansing gel: ...

Nature and contents of container

The Qutenza patch is stored in a paper coated aluminium foil sachet with acrylnitrile-acrylic acid copolymer ...

Special precautions for disposal and other handling

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. ...

Marketing authorization holder

Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Netherlands

Marketing authorization number(s)

EU/1/09/524/001-002

Date of first authorization / renewal of the authorization

15/05/2009

Date of revision of the text

21/02/2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.