Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Buprenorphine
Mundipharma Pty Ltd
Medicine Registered
NORSPAN ® _TRANSDERMAL DRUG DELIVERY SYSTEM_ _Buprenorphine (boo-pree-nor-feen)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NORSPAN Transdermal Drug Delivery System ("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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NORSPAN PATCHES ARE USED FOR NORSPAN patches contain buprenorphine. Buprenorphine belongs to a group of medicines called opioid analgesics. NORSPAN patches are used to relieve moderate to severe pain. Opioid analgesics such as buprenorphine have been used to treat pain for many years. Your doctor, however, may prescribe it for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. NORSPAN patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch can be worn for seven days. They should not be used for acute pain. As with all strong painkillers, your body may become used to you using buprenorphine patches. Using them may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop using buprenorphine suddenly, so it is important to use it exactly as directed by your doctor. This medicine is only available with a doctor's prescription. BEFORE YOU USE NORSPAN PATCHES _WHEN YOU MUST NOT USE_ _THEM_ DO NOT USE NORSPAN PATCHES IF YOU: • suffer from difficult or shallow breathing such as acute asthma, impaired lung function or chronic bronchitis • have confusion and shaking due to stopping drinking alcohol • have just had an operation or are about to have surgery on your spine for pain relie Olvassa el a teljes dokumentumot
NORSPAN ® transdermal patch PI (Orbis RA-0027 Mar 13) Supersedes mfpnorsp10712 mfpnorsp10313 Page 1 of 16 PRODUCT INFORMATION NORSPAN ® TRANSDERMAL DRUG DELIVERY SYSTEM 5, 10 AND 20 MICROGRAMS PER HOUR NAME OF THE MEDICINE Buprenorphine base (active). The structural formula is: CAS Registry Number: 52485-79-7 The inactive ingredients in NORSPAN transdermal drug delivery system (patch) are levulinic acid, oleyl oleate, povidone, Duro Tak 387-2051, Duro Tak 387-2054 and polyethylene terephthalate. DESCRIPTION Buprenorphine is a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether and slightly soluble in cyclohexane. The pKa is 8.5. The chemical name of buprenorphine is (2S)-2-[17-(cyclopropylmethyl)-4, 5α- epoxy-3-hydroxy-6-methoxy-6α, 14-ethano-14α-morphinan-7α-yl]-3, 3-dimethylbutan-2-ol. The molecular weight is 467.6 and the empirical formula is C 29 H 41 NO 4 . NORSPAN patches are either a rectangular (10 micrograms per hour), or square (5 and 20 micrograms per hour), beige-coloured, matrix patch with rounded corners, marked with the trade name and consisting of a protective liner and functional layers. Proceeding from the outer surface towards the surface adhering to the skin, the layers are (1) a beige-coloured web backing layer of polyester material; (2) an adhesive matrix rim without buprenorphine; (3) a separating foil over the adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and ( Olvassa el a teljes dokumentumot