FENTANYL SANDOZ fentanyl 37 micrograms/hour transdermal drug delivery system sachet

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

fentanyl, Quantity: 6.3 mg

제공처:

Sandoz Pty Ltd

INN (국제 이름):

Fentanyl

약제 형태:

Drug delivery system, transdermal

구성:

Excipient Ingredients: polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; 2,2'-azobisisobutyronitrile; 2-hydroxyethyl acrylate

관리 경로:

Transdermal

패키지 단위:

5, 10, 7, 8, 3, 2, 4, 1

처방전 유형:

(S8) Controlled Drug

치료 징후:

For the management of pain associated with cancer, palliative cancer and other conditions in patients where: - other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and - the pain is opioid-responsive, and - severe enough to require daily, continuous long term opioid treatment. Not for use in opioid-naive patients.

제품 요약:

Visual Identification: Dull, homogenous, rectangular transdermal drug delivery system on release liner, imprint on backing foil 'fentanyl 37.5 microgram/h'; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2009-12-22

제품 특성 요약

_Product Information Page 1 _
_Fentanyl Sandoz 12 / 25 / 37 / 50 / 75 / 100µg/h transdermal drug
delivery system _
_04/2017 _
_Sandoz Pty Ltd _
_ _
_Version 08 _
_ _
PRODUCT INFORMATION
FENTANYL SANDOZ
® 12 / 25 / 37 / 50 / 75 / 100ΜG/H
TRANSDERMAL DRUG DELIVERY SYSTEM
NAME OF THE MEDICINE
_ _
_Generic name: _
Fentanyl
_Chemical name: _
N-phenyl-N-[1-(2-phenylethyl)- 4-piperidinyl]propanamide
_Chemical structure: _
CAS:
437-38-7
Empirical formula:
C
22
H
28
N
2
O
MW:
336.5g/mol
DESCRIPTION
_ _
Fentanyl is a derivative of 4-anilinopiperidine. Fentanyl is a white
to off white solid
which is slightly soluble in aqueous neutral and alkaline solutions
but is readily
soluble in acidic aqueous solutions and organic solvents. It has a pKa
of 8.4 and a
partition
coefficient
(n-octanol:aqueous
buffer
pH
11)
log
P
of
3.94.
Two
polymorphic forms (I and II) have been identified for fentanyl,
although polymorphic
form II spontaneously converts to polymorphic form I.
Fentanyl Sandoz is a fentanyl matrix transdermal drug delivery system
(patch). It is a
drug in adhesive formulation designed to release fentanyl continuously
for 72 hours
after application to intact skin. It is available in six different
strengths delivering
fentanyl 12, 25, 37, 50, 75 or 100 micrograms/hour to the systemic
circulation. The
amount of fentanyl released from each patch per hour is proportional
to the surface
area. The composition per unit area of all patches is identical.
Fentanyl Sandoz is a transparent rounded oblong unit comprising a
protective liner
and two functional layers.
From the outer surface to the surface adhering to skin, these layers
include the
following: a backing of polyethylene terephthalate (PET) film; a drug
in adhesive
reservoir, which contains fentanyl and acrylic-vinylacetate copolymer;
an oversized
protective liner of siliconised PET.
Before use, the protective liner covering the adhesive layer is
removed and discarded.
_ _
_Product Information Page 2 _
_Fentanyl Sandoz 12 / 25 / 37 / 50 / 75 / 100µg/h transdermal drug
del