DENPAX fentanyl 25 micrograms/hour transdermal patch

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

fentanyl, Quantity: 2.55 mg

Tilgjengelig fra:

Alphapharm Pty Ltd

INN (International Name):

Fentanyl

Legemiddelform:

Drug delivery system, transdermal

Sammensetning:

Excipient Ingredients: dimeticone 360; polyethylene terephthalate; polyvinylidene flouride; methylated trimethylated silica; heptane; titanium dioxide; potable water; trolamine; strong ammonia solution; industrial methylated spirit; styrene/acrylates copolymer; polyethylene; polytef; dimeticone 350; docusate sodium; propylene glycol; purified water; acrylates copolymer; methoxyisopropyl acetate; 2-ethylhexyl acrylate; ethyl acetate; Polyisocyanate; 4,4'-diphenylmethane diisocyanate; Silane; polypropylene; ethylene/propylene copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; tris(2,4-ditert-butyphenyl) phosphite; calcium stearate; aluminium magnesium hydroxide carbonate; perflouropropylene/vinylidene diflouride copolymer; 1,3,5-trimethyl-2,4,6-tris(3,5-ditert-butyl-4-hydroxybenzyl)benzene; aluminium calcium sodium silicate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; iron oxide red; pigment yellow 119; zinc stearate

Administreringsrute:

Transdermal

Enheter i pakken:

5

Resept typen:

(S8) Controlled Drug

Indikasjoner:

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.

Produkt oppsummering:

Visual Identification: Translucent, rectangular patch with rounded corners, randomly printed with white ink "Fentanyl 2.55mg delivers 25ug/hr", on a removable release liner; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2010-12-07

Informasjon til brukeren

DENPAX
_TRANSDERMAL SYSTEM_
_fentanyl_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
DENPAX should only be used when your doctor decides that other
treatment options are not able to effectively manage your
pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
DENPAX poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment
LIFE THREATENING RESPIRATORY DEPRESSION
DENPAX can cause life-threatening or fatal breathing difficulties
(slow, shallow, unusual or no breathing) even when used
as recommended. These problems can occur at any time during use but
the risk is higher when first starting DENPAX and
after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change
the dose as appropriate.
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL
Using DENPAX with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and
alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will mini-
mise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You must
not drink alcohol while using DENPAX.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DENPAX. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DENPAX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DENPAX IS USED
FOR
DENPAX is used to relieve chronic

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
DENPAX
_fentanyl transdermal patch _
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, DENPAX should
only be used in patients for
whom other treatment options, including non-opioid analgesics, are
ineffective, not tolerated or
otherwise inadequate to provide appropriate management of pain (see
section 4.4 Special Warnings
and Precautions for Use).
HAZARDOUS AND HARMFUL USE
DENPAX poses risks of hazardous and harmful use which can lead to
overdose and death. Assess the
patient’s risk of hazardous and harmful use before prescribing and
monitor the patient regularly during
treatment (see section 4.4. Special Warnings and Precautions for Use).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of DENPAX. Be aware
of situations which increase the risk of respiratory depression,
modify dosing in patients at risk and
monitor patients closely, especially on initiation or following a dose
increase (see section 4.4 Special
Warnings and Precautions for Use).
CONCOMITANT
USE
OF
BENZODIAZEPINES
AND
OTHER
CENTRAL
NERVOUS
SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant
use
of
opioids
with
benzodiazepines,
gabapentinoids,
antihistamines,
tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death. Limit dosages and
durations to the minimum required; and monitor patients for signs and
symptoms of respiratory
depression and sedation. Caution patients not to drink alcohol while
taking DENPAX.
1
NAME OF THE MEDICINE
Fentanyl
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in DENPAX is fentanyl.
DENPAX transdermal drug delivery systems are available in five
different strengths.
a
The lowest dose is designated as 12 micrograms/hour (however, the
actual dosage is 12.5
micrograms/hour) to distinguish it from a 125 micrograms/hour dosage
that co