Fentanyl HEXAL MAT 25 mcgh Transdermal Patch

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

FENTANYL BASE

Tilgjengelig fra:

IMEKS PHARMA SDN. BHD.

INN (International Name):

FENTANYL BASE

Enheter i pakken:

20Pieces Pieces; 5Pieces Pieces; 10Pieces Pieces

Produsert av:

HEXAL AG

Preparatomtale

KEY
die cut
pharma code area
die cut
pharma code area
LEAFLET
valid after 01.12.2012
165 mm
620 mm
143 mm
11 mm
11 mm
11 mm
11 mm
11 mm
11 mm
11 mm
165 mm
620 mm
143 mm
11 mm
11 mm
11 mm
11 mm
11 mm
11 mm
Example for the pre folded
leaflet
45 mm
80 mm
45 mm
80 mm
45x80 mm
45x80 mm
Reading direction Barcode
Leserichtung Laetus-Code
Placement of Materialnumber
55 mm from Paper edge
46218807
CONTENT
Fentanyl-HEXAL
®
MAT
25
µg/h:
One
transdermal
patch
(10.5cm
2
absorption area) contains 5.78 mg fentanyl (equivalent to 25µg/hour
agent
release).
Fentanyl-HEXAL
®
MAT
50
µg/h:
One
transdermal
patch
(21cm
2
absorption area) contains 11.56 mg fentanyl (equivalent to 50µg/hour
agent
release).
Transdermal system provides continuous systemic delivery of fentanyl,
a
potent opioid analgesic, for 72 hours.
DESCRIPTION
Transparent,
rounded,
right-angled
transdermal
patch,
consisting
of
a
protective foil (to be removed before using the patch) and two
functional
layers: a fentanyl-containing self-adhesive matrix layer and a
waterproof
carrier foil.
Size of the transdermal patch Fentanyl-HEXAL
®
MAT 25 µg/h is 10.5cm
2
and Fentanyl- HEXAL
®
MAT 50 µg/h is 21cm
2
.
The transdermal patch consists of two functional layers:
The upper side consists of a waterproof carrier foil. On it is a
fentanyl-
containing self-adhesive matrix layer. This matrix layer is covered by
a
stripping foil which is easily to be removed prior to use.
According to the different sizes of the absorption area of the two
systems of
10.5 and 21 cm
2
, about 25 and 50 micrograms fentanyl per hour is released
to the skin. This is guaranteed by the polymer matrix: along a
concentration
gradient between the drug-containing polymer matrix with high fentanyl
concentration and the skin with low fentanyl concentration, fentanyl
diffuses
through the diffusion-controlled membrane towards the lower concentra-
tion, i.e. towards the skin, continuously over a period of 72 hours.
The relative bioavailability of a transdermal patch of Fentanyl-HEXAL
®
MAT
is 92%. The di