מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BUPRENORFINE
Sandoz B.V.
N02AE01
BUPRENORPHINE
Pleister voor transdermaal gebruik
BLAUWE INKT ; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT (75,0), BUTYLACRYLAAT (15,0), ACRYLZUUR (5,0), VINYLACETAAT (5,0) MET ALUMINIUMACETYLACETONAAT ALS CROSSLINKINGAGENT ; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, GLYCIDYLMETHACRYLAAT, HYDROXYETHYLACRYLAAT, VINYLACETAAT ; LEVULINEZUUR ; OLEYLOLEAAT ; POLYESTER ; POLYETHYLEENTEREPHTHALAAT ; POLYETHYLEENTEREPHTHALAAT, GESILICONEERD ; POVIDON K 90 (E 1201),
Transdermaal gebruik
Buprenorphine
Hulpstoffen: BLAUWE INKT; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, GLYCIDYLMETHACRYLAAT, HYDROXYETHYLACRYLAAT, VINYLACETAAT; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT (75,0), BUTYLACRYLAAT (15,0), ACRYLZUUR (5,0), VINYLACETAAT (5,0) MET ALUMINIUMACETYLACETONAAT ALS CROSSLINKINGAGENT; LEVULINEZUUR; OLEYLOLEAAT; POLYESTER; POLYETHYLEENTEREPHTHALAAT; POLYETHYLEENTEREPHTHALAAT, GESILICONEERD; POVIDON K 90 (E 1201);
2017-01-19
Sandoz B.V. Page 1/11 Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister voor transdermaal gebruik RVG 118909-10-11 1313-V3 1.3.1.3 Bijsluiter April 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER BUPRENORFINE SANDOZ ® PLEISTER 5 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK BUPRENORFINE SANDOZ ® PLEISTER 10 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK BUPRENORFINE SANDOZ ® PLEISTER 20 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK 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 [Nationally completed name] is and what it is used for 2. What you need to know before you use [Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains the active substance buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. It has been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller. [Nationally completed name] should not be used to relieve acute pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME] DO NOT USE [NATIONALLY COMPLETED NAME] IF YOU are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6); have breathing problems; are addicted to drugs; are taking a type קרא את המסמך השלם
Sandoz B.V. Page 1/13 Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister voor transdermaal gebruik RVG 118909-10-11 1311-V3 1.3.1.1 Samenvatting van de Productkenmerken April 2019 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Buprenorfine Sandoz pleister 5 microgram/uur, pleister voor transdermaal gebruik Buprenorfine Sandoz pleister 10 microgram/uur, pleister voor transdermaal gebruik Buprenorfine Sandoz pleister 20 microgram/uur, pleister voor transdermaal gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [5 micrograms/h:] Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm² area releasing a nominal 5 micrograms of buprenorphine per hour over a period of 7 days. [10 micrograms/h:] Each transdermal patch contains 10 mg of buprenorphine in a 12.5 cm² area releasing a nominal 10 micrograms of buprenorphine per hour over a period of 7 days. [20 micrograms/h:] Each transdermal patch contains 20 mg of buprenorphine in a 25 cm² area releasing a nominal 20 micrograms of buprenorphine per hour over a period of 7 days. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch [5 micrograms/h:] Rectangular beige coloured patch with rounded edges and imprinted with “Buprenorphin” and “5 μg/h” in blue colour. [10 micrograms/h:] Rectangular beige coloured patch with rounded edges and imprinted with “Buprenorphin” and “10 μg/h” in blue colour. [20 micrograms/h:] Rectangular beige coloured patch with rounded edges and imprinted with “Buprenorphin” and “20 μg/h ” in blue colour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. [Nationally completed name] is not suitable for the treatment of acute pain. [Nationally completed name] is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/13 Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister voor transdermaal gebruik RVG 118909-10 קרא את המסמך השלם