DUTRAN 100 fentanyl 100 mcg/hr transdermal patch pouch

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

fentanyl, Quantity: 16.5 mg

可用日期:

Medis Pharma Pty Ltd

INN（国际名称）:

Fentanyl

药物剂型:

Drug delivery system, transdermal

组成:

Excipient Ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane

给药途径:

Transdermal

每包单位数:

5 patches

处方类型:

(S8) Controlled Drug

疗效迹象:

For the management of pain associated with cancer, palliative care, 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-na?ve patients.

產品總結:

Visual Identification: Rectangular, round cornered, transparent and colourless patch with 30 cm2 active surface area contained in a protective pouch made from composite foil.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2012-08-28

资料单张

DUTRAN CMI 050315
Page
1 of 5
DUTRAN TRANSDERMAL DRUG DELIVERY SYSTEM
_ contains the active ingredient fentanyl _
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DUTRAN. 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 using DUTRAN
against the benefits this medicine
is expected to have for you.
If you have any concerns about
using DUTRAN, ask your doctor
or pharmacist.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT DUTRAN IS USED
FOR
DUTRAN is used to relieve chronic
or long-lasting pain, which
requires strong painkillers.
DUTRAN contains a medicine
called fentanyl. This strong pain
reliever belongs to a group of
medicines known as
opioid
analgesics. Fentanyl
relieves pain
by blocking the nerves that
recognise pain messages from the
body.
Each patch is applied onto the skin
every 72 hours (3 days). The patch
releases a continuous amount of
fentanyl that is absorbed through
the skin in contact with the patch.
Your doctor may have prescribed
DUTRAN for another reason. Ask
your doctor if you have any
questions about why this medicine
has been prescribed for you.
_Warning _
_ _
DUTRAN PATCHES MAY BE
RETRIEVED AND ABUSED BY ADDICTS.
PLEASE ENSURE THAT USED PATCHES
ARE CONCEALED AND DISPOSED OF
CAREFULLY. RETURN UNUSED PATCHES
TO THE PHARMACY (SEE DISPOSAL AT
THE END OF THIS LEAFLET).
KEEP USED AND UNUSED PATCHES
WHERE CHILDREN CANNOT REACH
THEM.
BEFORE YOU USE DUTRAN
_When you must not use it _
_ _
Do not use DUTRAN
•
if you have an allergy to
fentanyl or any of the
ingredients. See Product
Description at the end of this
leaflet for a list of ingredients.
•
for acute pain or pain following
surgery
•
for mild or intermittent pain
•
at a starting dose greater than
25 micrograms/hour if you
have never had opioid
analgesics for pain relief.
Do not use DUTRAN if the
packaging is

产品特点

AUSTRALIAN PRODUCT INFORMATION - DUTRAN
TM (FENTANYL)
TRANSDERMAL DRUG DELIVERY SYSTEM
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Dutran 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 _
Dutran 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 Dutran. 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 Dutran.
1.
NAME OF THE MEDICINE
Fentanyl
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dutran is available in five different strengths delivering fentanyl
12, 25, 50, 75 or 100
microgram/hour to the systemic circulation.
DUTRAN 12
– Each transdermal patch with 3.75 cm
2
active surface area contains 2.063 mg
fentanyl with a rele