DUROGESIC fentanyl 12 micrograms/h transdermal patch sachet

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

fentanyl, Quantity: 2.1 mg

Saadav alates:

Janssen-Cilag Pty Ltd

INN (Rahvusvaheline Nimetus):

Fentanyl

Ravimvorm:

Drug delivery system, transdermal

Koostis:

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

Manustamisviis:

Topical

Ühikuid pakis:

5 patches

Retsepti tüüp:

(S8) Controlled Drug

Näidustused:

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.

Toote kokkuvõte:

Visual Identification: Rectangular shape with rounded corners, translucent system with printed border and "Durogesic 12 mcg fentanyl/h" in orange ink.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2005-11-23

Infovoldik

DUROGESIC
®
1
DUROGESIC
®
_TRANSDERMAL SYSTEM _
_Fentanyl _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
DUROGESIC 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
DUROGESIC 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
DUROGESIC 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 DUROGESIC 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 DUROGESIC 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
minimise 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 DUROGESIC.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DUROGESIC
patches. 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 DUROGESIC
against the benefits this medicine is
expected to have for you.
If you have any concerns about using
DUROGESIC, ask your doctor or
pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT

Toote omadused

CCDSv15 200206
1
DUROGESIC(200723)API
DUROGESIC

FENTANYL
AUSTRALIAN
PRODUCT
INFORMATION
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, DUROGESIC
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
DUROGESIC 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 DUROGESIC. 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
DUROGESIC.
1. NAME OF THE MEDICINE
Fentanyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in DUROGESIC is fentanyl.
DUROGESIC is 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 DOSAG