Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
buprenorphine, Quantity: 40 mg
Mundipharma Pty Ltd
Buprenorphine
Drug delivery system, transdermal
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
Transdermal
4 patches, 2 patches
(S8) Controlled Drug
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.
Visual Identification: Beige coloured rectangular patch with rounded corners on an aluminised rigid removable protective layer. The trade name and the strength is printed on the patch.; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-09-07
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 Lees het volledige document
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, Lees het volledige document