Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Buprenorphine
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
Buprenorphine
2Pieces Pieces
LTS LOHMANN THERAPIE-SYSTEM AG
_CONSUMER_ _ _ _MEDICATION_ _ _ _INFORMATION_ _ _ _LEAFLET_ _ _ _(RIMUP)_ _ _ 1 SOVENOR ® TRANSDERMAL PATCH Buprenorphine (5mcg/hr, 10mcg/hr, 20mcg/hr) WHAT IS IN THIS LEAFLET 1. What Sovenor ® is used for 2. How Sovenor ® works 3. Before you use Sovenor® 4. How to use Sovenor ® 5. While you are taking it 6. Side effects 7. Storage and Disposal of Sovenor ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SOVENOR ® IS USED FOR These patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. They have been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller. HOW SOVENOR ® WORKS Sovenor® patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch can be worn up to seven days. They should not be used to relieve acute pain. BEFORE YOU TAKE SOVENOR ® _-When you must not use it _ Do not use Sovenor ® if you: - are allergic (hypersensitive) to buprenorphine or any of the other ingredients of Sovenor ® (see section ‘Product Description’); - have breathing problems such as acute asthma, impaired lung function or chronic bronchitis; - are addicted to drugs; - are taking a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks; - suffer from myasthenia gravis, a condition in which the muscles become weak and tire easily; - have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol; - are pregnant . Sovenor® must not be used to treat symptoms associated with drug withdrawal. _-Before you start take it _ - Before treatment with these patches tell your doctor or pharmacist if you:are treated with antidepressants. The use of these medicines together with Sovenor ® patches can lead to serotonin syndrome, a potentially life-threatening condit Lees het volledige document
PACKAGE INSERT _SOVENOR_® 5 MICROGRAMS/H TRANSDERMAL PATCH _SOVENOR_® 10 MICROGRAMS/H TRANSDERMAL PATCH _SOVENOR_® 20 MICROGRAMS/H TRANSDERMAL PATCH COMPOSITION _Buprenorphine _ Buprenorphine is a white or almost white crystalline powder very slightly soluble in water, freely soluble in acetone, soluble in methanol, ethanol and diethyl ether, and slightly soluble in cyclohexane. The chemical name is (2S)-2-[(-)- (5R,6R,7R,14S)-9α-cyclopropylmethyl- 4,5-epoxy-6,14-ethanomorphinan-7-yl] -3-hydroxy-6-methoxy-3,3- dimethylbutan-2-ol (CAS No:52485-79-7). The molecular formula is C29H41NO4 and molecular weight is 467.6. The inactive ingredients in _SOVENOR_® transdermal patches are: Adhesive matrix (containing buprenorphine): [(Z)- octadec-9-en-1-yl] oleate, povidone K90, 4oxopentanic acid, poly[acrylic acid-cobutylacrylate-co-(2- ethylhexyl)acrylate-covinylacetate] (5:15:75:5), crosslinked. Adhesive matrix (without buprenorphine): poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl) acrylate-co- vinylacetate] (5:15:75:5). Separating foil between the adhesive matrices with and without buprenorphine: poly(ethyleneterephthalate) – foil. Backing layer: poly(ethyleneterephthalate) – tissue. Release liner (on the front covering the adhesive matrix containing buprenorphine) (to be removed before applying the patch): poly(ethyleneterephthalate) – foil, siliconised, coated on one side with aluminium. DESCRIPTION _SOVENOR_® 5 MICROGRAMS/H TRANSDERMAL PATCH: contains 5 mg buprenorphine, with a release rate of 5 micrograms per hour, to be administered every 7 th day. Square, beige coloured patch with rounded corners marked _SOVENOR_® 5 mg 5 μg/h Area containing active substance: 6.25 cm 2 _SOVENOR_® 10 MICROGRAMS/H TRANSDERMAL PATCH: contains 10 mg buprenorphine, with a release rate of 10 micrograms per hour, to be administered every 7 th day. Square, beige coloured patch with rounded corners marked _SOVENOR_® 10 mg 10 μg/h Area containing active substance: 12.5 cm 2 _SOVENOR_® 20 MICROGRAMS/H TRANSDERMAL PATCH: Lees het volledige document