BUPREDERMAL buprenorphine 5 micrograms/hour transdermal drug delivery system sachet

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

buprenorphine, Quantity: 5 mg

Tilgjengelig fra:

Mundipharma Pty Ltd

INN (International Name):

Buprenorphine

Legemiddelform:

Drug delivery system, transdermal

Sammensetning:

Excipient Ingredients: levulinic acid; oleyl oleate; povidone; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; heptane; aluminium acetylacetonate

Administreringsrute:

Transdermal

Enheter i pakken:

2 Sachet, 4 Sachets, 1 Sachet

Resept typen:

(S8) Controlled Drug

Indikasjoner:

BUPREDERMAL patches are indicated for the management of severe pain 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 ? requires daily, continuous, long-term treatment. BUPREDERMAL patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. BUPREDERMAL patches are not indicated as an as-needed (PRN) analgesia.

Produkt oppsummering:

Visual Identification: Beige coloured square patch with rounded corners on a aluminised rigid removable protective layer.The trade name and the strength are printed on the patch.; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2017-09-07

Informasjon til brukeren

BUPREDERMAL® Transdermal Drug Delivery System
1
BUPREDERMAL
® TRANSDERMAL DRUG DELIVERY SYSTEM
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING BUPREDERMAL PATCHES?
BUPREDERMAL Transdermal Drug Delivery System ("patches") contain the
active ingredient buprenorphine. BUPREDERMAL
patches are used for the management of pain severe enough to require
daily, long-term opioid treatment and for which other
forms of treatment have failed or are otherwise inappropriate to
provide sufficient management of pain.
For more information, see Section 1. Why am I using BUPREDERMAL
patches? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BUPREDERMAL PATCHES?
Do not use if you have ever had an allergic reaction to buprenorphine
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
BUPREDERMAL patches? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BUPREDERMAL patches and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BUPREDERMAL PATCHES?
•
Your doctor will tell you exactly how much to take.
•
Follow the instructions given to you by your doctor or your
pharmacist.
More instructions can be found in Section 4. How do I use BUPREDERMAL
patches? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BUPREDERMAL PATCHES?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using BUPREDERMAL
patches.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you relax,
a

Preparatomtale

BUPREDERMAL
®
PATCH
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION – BUPREDERMAL
®
(BUPRENORPHINE) TRANSDERMAL DRUG DELIVERY SYSTEM
(PATCH)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, BUPREDERMAL
patches 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 _
BUPREDERMAL patches pose 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
BUPREDERMAL patches. 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
using BUPREDERMAL patches._ _
1
NAME OF THE MEDICINE
Buprenorphine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUPREDERMAL
patches are available in seven strengths: 5 micrograms per hour, 10
micrograms per hour, 15 micrograms per hour, 20 micrograms per hour,