Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
buprenorphine, Quantity: 5 mg
Sandoz Pty Ltd
Buprenorphine
Drug delivery system, transdermal
Excipient Ingredients: levulinic acid; oleyl oleate; povidone; polyethylene; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/MDI copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate
Transdermal
4, 2, 1
(S8) Controlled Drug
BUPRENORPHINE SANDOZ 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. BUPRENORPHINE SANDOZ patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. BUPRENORPHINE SANDOZ patches are not indicated as an as-needed (PRN) analgesia.
Visual Identification: Rectangular transdermal patch with rounded edges having transparent release liner on bottom side and pale yellowish-brown adhesive foil imprinted (in black ink) with "Buprenorphinum 5 micrograms/h" on upper side; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-06-16
Buprenorphine Sandoz® 1 BUPRENORPHINE SANDOZ® 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 BUPRENORPHINE SANDOZ? Buprenorphine Sandoz Transdermal Drug Delivery System (“patches”) contains the active ingredient buprenorphine. Buprenorphine Sandoz 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 Buprenorphine Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BUPRENORPHINE SANDOZ? 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 Buprenorphine Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Buprenorphine Sandoz 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 BUPRENORPHINE SANDOZ? • 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 Buprenorphine Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BUPRENORPHINE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using Buprenorphine Sandoz. • Tell your doctor or pharmacist if you are taking any other medicines that you use to h Read the complete document
210329-Buprenorphine Sandoz-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION BUPRENORPHINE SANDOZ (BUPRENORPHINE BASE) TRANSDERMAL DRUG DELIVERY SYSTEM 1. NAME OF THE MEDICINE Buprenorphine base 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Buprenorphine Sandoz is a buprenorphine matrix transdermal drug delivery system (patch) and is available in seven strengths: 5 micrograms per hour, 10 micrograms per hour, 15 micrograms per hour, 20 micrograms per hour, 25 micrograms per hour, 30 micrograms per hour and 40 micrograms per hour. The composition of all seven strengths is identical except for patch size. The proportion of buprenorphine in the adhesive matrix is the same in each strength. The amount of buprenorphine released from each system per hour is proportional to the surface area of the patch. The skin is the limiting barrier to diffusion from the system into the bloodstream. _Buprenorphine Sandoz 5 micrograms/h _ WARNINGS _LIMITATIONS OF USE_ Because of the risks associated with the use of opioids, Buprenorphine Sandoz 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_ Buprenorphine Sandoz 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 Buprenorphine Sandoz. Be aware of situations which increase 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 Read the complete document