Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
capsaicin
GP Grenzach Produktions GmbH
N01BX04
capsaicin
179mg/280cm^2
transdermal therapeutic system
sachet and 50g cleansing gel in tube
Prescription
Registered
2020-05-12
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Qutenza 179 mg cutaneous patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 280 cm 2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm 2 of patch. Excipient with known effect Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm 2 ) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with ‘capsaicin 8%’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain. 4.2 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 The cutaneous patch should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful area should be determined by the physician and marked on the skin. Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy, painful diabetic peripheral neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia). Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain. The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of Qutenza to reduce potential application related discomfort. The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding Belgenin tamamını okuyun