Qutenza transdermal therapeutic system

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

capsaicin

Fáanlegur frá:

GP Grenzach Produktions GmbH

ATC númer:

N01BX04

INN (Alþjóðlegt nafn):

capsaicin

Skammtar:

179mg/280cm^2

Lyfjaform:

transdermal therapeutic system

Einingar í pakka:

sachet and 50g cleansing gel in tube

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2020-05-12

Vara einkenni

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