QUTENZA Cutaneous patch (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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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 cm² of patch. Excipient with known effect: Each 50 g tube of cleansing gel for Qutenza contains 0.2 ...
Pharmaceutical form
Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm²) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, ...
Therapeutic indications
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.
Posology and method of administration
The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician. Posology Qutenza should be applied to the most painful skin areas (using ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Health care professionals should wear nitrile gloves when handling patches and when cleansing treatment areas (see section 4.2). It is advisable to administer Qutenza in a well ventilated treatment area. ...
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 levels of systemic absorption have been shown to occur with Qutenza.
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of capsaicin in pregnant women. Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the likelihood that ...
Effects on ability to drive and use machines
Qutenza has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Of the 1826 patients treated with Qutenza in randomized controlled trials, 1089 (59.6%) reported adverse reactions considered related to the medicinal product by the investigator. ...
Overdose
No case of overdose has been reported. Qutenza is required to be administered by a physician or under the supervision of a physician. Therefore, overdosing is unlikely to occur. Overdose may be associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anaesthetics, other local anaesthetics ATC code: N01BX04 Mechanism of action Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective ...
Pharmacokinetic properties
The capsaicin contained in Qutenza is intended for delivery into the skin. In vitro data (active substance dissolution and skin permeation assays) demonstrate that the rate of release of capsaicin from ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, and repeated-dose toxicity. Genotoxicity studies performed with capsaicin ...
List of excipients
Patch: Matrix: Silicone adhesives Diethylene glycol monoethyl ether Silicone oil Ethylcellulose N50 (E462) Backing layer: Polyester backing film Printing ink containing Pigment White 6 Removable protective ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 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: Store below 25°C.
Nature and contents of container
The Qutenza patch is stored in a paper coated aluminium foil sachet with acrylnitrile-acrylic acid copolymer heat seal layer. Qutenza is available in a kit containing one or two individually sealed Qutenza ...
Special precautions for disposal and other handling
Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. The use of a mask and protective glasses is recommended, see section 4.2. Used and unused patches ...
Marketing authorization holder
Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
Marketing authorization number(s)
EU/1/09/524/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
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