Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine
Grunenthal Ltd
N02AE01
Buprenorphine
70microgram/1hour
Transdermal patch
Transdermal
Schedule 3 (CD No Register)
Caution - AMP level prescribing advised
BNF: 04070200; GTIN: 5012854067103
PACKAGE LEAFLET: INFORMATION FOR THE USER TRANSTEC ® 35 MICROGRAMS/H / 52.5 MICROGRAMS/H / 70 MICROGRAMS/H TRANSDERMAL PATCH Buprenorphine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Transtec is and what it is used for 2. What you need to know before you use Transtec 3. How to use Transtec 4. Possible side effects 5. How to store Transtec 6. Further information 1. WHAT TRANSTEC IS AND WHAT IT IS USED FOR Transtec is an analgesic (a pain-relieving medicine) intended to relieve moderate to severe cancer pain and severe pain that has not responded to other types of painkillers. Transtec acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through the skin into the blood. Buprenorphine is an opioid (strong pain reliever), which reduces pain by acting on the central nervous system (specific nerve cells in the spinal cord and in the brain). The effect of the transdermal patch lasts for up to four days. Transtec is not suitable for the treatment of acute (short-lasting) pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRANSTEC DO NOT USE TRANSTEC, - if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6); - if you are dependent on strong pain relievers (opioids); - if you suffer from a disease in which you have or may have great difficulty breathing - if you are taking monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression) or you have taken this type of medicine i Belgenin tamamını okuyun
OBJECT 1 TRANSTEC 35 MICROGRAMS TRANSDERMAL PATCH Summary of Product Characteristics Updated 24-Apr-2015 | Napp Pharmaceuticals Limited 1. Name of the medicinal product TRANSTEC 35 ® micrograms/h transdermal patch TRANSTEC 52.5 ® micrograms/h transdermal patch TRANSTEC 70 ® micrograms/h transdermal patch 2. Qualitative and quantitative composition TRANSTEC 35 micrograms/h transdermal patch: One transdermal patch contains 20 mg buprenorphine. Area containing the active substance: 25 cm 2 Nominal release rate: 35 micrograms of buprenorphine per hour (over a period of 96 hours). TRANSTEC 52.5 micrograms/h transdermal patch: One transdermal patch contains 30 mg buprenorphine. Area containing the active substance: 37.5 cm 2 Nominal release rate: 52.5 micrograms of buprenorphine per hour (over a period of 96 hours). TRANSTEC 70 micrograms/h transdermal patch: One transdermal patch contains 40 mg buprenorphine. Area containing the active substance: 50 cm 2 Nominal release rate: 70 micrograms of buprenorphine per hour (over a period of 96 hours). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Skin coloured transdermal patch with rounded corners marked: TRANSTEC 35 µg/h, buprenorphinum 20 mg TRANSTEC 52.5 µg/h, buprenorphinum 30 mg TRANSTEC 70 µg/h, buprenorphinum 40 mg 4. Clinical particulars 4.1 Therapeutic indications Moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics. TRANSTEC is not suitable for the treatment of acute pain. 4.2 Posology and method of administration Posology _Patients over 18 years of age_ The TRANSTEC dosage should be adapted to the condition of the individual patient (pain intensity, suffering, individual reaction). The lowest possible dosage providing adequate pain relief should be given. Three transdermal patch strengths are available to provide such adaptive treatment: TRANSTEC 35 micrograms/h, TRANSTEC 52.5 micrograms/h and TRANSTEC 70 micrograms/h. _Initial dose selection_: patients who have previously Belgenin tamamını okuyun