País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Buprenorphine 20mg; ;
Mundipharma New Zealand Ltd
Buprenorphine 20 mg
20 mg
Transdermal patch
Active: Buprenorphine 20mg Excipient: Polyacrylate. Durotak 387.2054 and Durotak 387.2051 Levulinic acid Oleyl oleate Povidone
Sachet, laminate, 2 individual wrapped patches, 2 patches
Class C4 Controlled Drug
Class C4 Controlled Drug
Janssen Pharmaceutica NV
Management of moderate to severe pain.
Package - Contents - Shelf Life: Sachet, laminate, 2 individual wrapped patches - 2 patches - 36 months from date of manufacture stored at or below 25°C
2006-03-17
NORSPAN ® PATCH 1 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 should be worn for seven days. 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. Selling or giving away NORSPAN is against the law. BEFORE YOU USE NORSPAN PATCHES _WHEN YOU MUST NOT USE _ _THEM _ DO NOT USE NORSPAN PATCHES IF YOU: have any breathing problems or have a condition where your lung function is severely impaired 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 Llegiu el document complet
NEW ZEALAND DATA SHEET NORSPAN® PATCH – NORSP010 Aug 2022 Page 1 of 21 NORSPAN® TRANSDERMAL PATCH Buprenorphine 1 PRODUCT NAME NORSPAN® 5mg Patch NORSPAN® 10mg Patch NORSPAN® 20mg Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NORSPAN® patch 5 Each square patch releases buprenorphine 5 micrograms per hour over 7 days The area containing the active substance: 6.25 cm 2 Total buprenorphine content: 5mg NORSPAN® patch 10 Each rectangular patch releases buprenorphine 10 micrograms per hour over 7 days The area containing the active substance: 12.5 cm 2 Total buprenorphine content: 10mg NORSPAN® patch 20 Each square patch releases buprenorphine 20 micrograms per hour over 7 days The area containing the active substance: 25 cm 2 Total buprenorphine content: 20mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM NORSPAN® patch is either rectangular (10 micrograms/hr) or square (5 and 20 micrograms/hr) 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 layer (“foil”) consisting of polyethylene terephthalate over the adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a release liner. Before use the release liner covering the adhesive layer is removed and discarded. FIGURE 1: Cross section drawing of NORSPAN® patch NEW ZEALAND DATA SHEET NORSPAN® PATCH – NORSP010 Aug 2022 Page 2 of 21 NORSPAN® patch is available in three different strengths: 5 micrograms per hour, 10 micrograms per hour and 20 micrograms per hour. The composition of all three strengths is identical except for patch size. The proportion of buprenorphine in the adhesive matrix is the same in each strength (10% by weight). The amount of buprenorphine released from each system per hour is proportio Llegiu el document complet