Fentavera patch transdermal

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

fentanyl

Beszerezhető a:

Acino AG

ATC-kód:

N02AB03

INN (nemzetközi neve):

fentanyl

Adagolás:

50mcg/h

Gyógyszerészeti forma:

patch transdermal

db csomag:

(5) patches

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2022-05-11

Termékjellemzők

V030 – May 2019 (PSUSA)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fentavera 12.5 micrograms/hour transdermal patch
Fentavera 25 micrograms/hour transdermal patch
Fentavera 50 micrograms/hour transdermal patch
Fentavera 75 micrograms/hour transdermal patch
Fentavera 100 micrograms/hour transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentavera 12.5 micrograms/hour:
1 transdermal
patch
contains
2.55 mg
fentanyl
in
a
patch
size
of
4.25 cm
2
and
releases
12.5 micrograms fentanyl per hour.
Fentavera 25 micrograms/hour:
1 transdermal patch contains 5.1 mg fentanyl in a patch size of 8.5 cm
2
and releases 25 micrograms
fentanyl per hour.
Fentavera 50 micrograms/hour:
1 transdermal patch contains 10.2 mg fentanyl in a patch size of 17 cm
2
and releases 50 micrograms
fentanyl per hour.
Fentavera 75 micrograms/hour:
1 transdermal patch contains 15.3 mg fentanyl in a patch size of 25.5
cm
2
and releases 75 micrograms
fentanyl per hour.
Fentavera 100 micrograms/hour:
1 transdermal patch contains 20.4 mg fentanyl in a patch size of 34 cm
2
and releases 100 micrograms
fentanyl per hour.
Excipient with known effect: soya oil (Ph.Eur.)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Fentavera is an opaque, colourless, rectangular-shaped patch with
round corners and imprint on the
backing foil:
“Fentanyl 12 µg/h” for Fentavera 12.5 micrograms/hour
“Fentanyl 25 µg/h” for Fentavera 25 micrograms/hour
“Fentanyl 50 µg/h” for Fentavera 50 micrograms/hour
“Fentanyl 75 µg/h” for Fentavera 75 micrograms/hour
“Fentanyl 100 µg/h” for Fentavera 100 micrograms/hour
4.
CLINICAL PARTICULARS
V030 – May 2019 (PSUSA)
4.1
THERAPEUTIC INDICATIONS
Adults
Fentavera is indicated for management of severe chronic pain that
requires continuous long-term
opioid administration.
Children
Long-term management of severe chronic pain in children from 2 years
of age who are already
receiving opioid therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Po