Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NALOXONHYDROCHLORIDE 2-WATER SAMENSTELLING overeenkomend met ; ; NALOXON ; OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; OXYCODON
Mundipharma Pharmaceuticals B.V.
N02AA55
NALOXONHYDROCHLORIDE 2-WATER COMPOSITION corresponding to ; ; NALOXONE ; OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; ; OXYCODONE
Tablet met verlengde afgifte
ETHYLCELLULOSE (E 462) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; STEARYLALCOHOL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Oxycodone and naloxone
Hulpstoffen: ETHYLCELLULOSE (E 462); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); STEARYLALCOHOL; TALK (E 553 B); TITAANDIOXIDE (E 171);
2013-12-30
NL PL Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg Versie 10 januari 2019 Pagina 1 van 10 PACKAGE LEAFLET: INFORMATION FOR THE USER TARGINACT 2,5 MG/1,25 MG, TABLET MET VERLENGDE AFGIFTE TARGINACT 15 MG/7,5 MG, TABLET MET VERLENGDE AFGIFTE TARGINACT 30 MG/15 MG, TABLET MET VERLENGDE AFGIFTE Oxycodone hydrochloride/naloxone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Targinact is and what it is used for 2. What you need to know before you take Targinact 3. How to take Targinact 4. Possible side effects 5. How to store Targinact 6. Contents of the pack and other information 1. WHAT TARGINACT IS AND WHAT IT IS USED FOR Targinact is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours. You have been prescribed Targinact for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation. These tablets are only for use in adults. How these tablets work These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Targinact, and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of Targinact, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers. 2. WHAT YOU Przeczytaj cały dokument
NL SmPC Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg Versie 7 juni 2018 Pagina 1 van 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Targinact 2,5 mg/1,25 mg, tablet met verlengde afgifte Targinact 15 mg/7,5 mg, tablet met verlengde afgifte Targinact 30 mg/15 mg, tablet met verlengde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION_ _ {Targinact 2.5 mg/1.25 mg} Each prolonged-release tablet contains 2.5 mg of oxycodone hydrochloride equivalent to 2.25 mg oxycodone and 1.25 mg naloxone hydrochloride as 1.37 mg of naloxone hydrochloride dihydrate equivalent to 1.13 mg naloxone. {Targinact 15 mg/7.5 mg} Each prolonged-release tablet contains 15 mg of oxycodone hydrochloride equivalent to 13.5 mg oxycodone and 7.5 mg naloxone hydrochloride as 8.24 mg of naloxone hydrochloride dihydrate equivalent to 6.75 mg naloxone. {Targinact_ _30 mg/15 mg} Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride equivalent to 27 mg oxycodone and 15 mg naloxone hydrochloride as 16.48 mg of naloxone hydrochloride dihydrate equivalent to 13.5mg naloxone {Targinact 2.5 mg/1.25 mg} Excipient with known effect: Each prolonged-release tablet contains 34.1 mg lactose anhydrous {Targinact 15 mg/7.5 mg} Excipient with known effect: Each prolonged-release tablet contains 53.0 mg lactose anhydrous {Targinact_ _30 mg/15 mg} Excipient with known effect: Each prolonged-release tablet contains 36.5 mg lactose anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet _{Targinact 2.5 mg/1.25 mg} _ Light yellow, round tablets, 5mm in size, with a film coating. _{Targinact 15 mg/7.5 mg} _ Grey, oblong tablets, with a nominal length of 9.5mm and with a film coating, embossed “OXN” on one side and “15” on the other. _{Targinact 30 mg/15 mg} _ Brown, oblong tablets, with a nominal length of 9.5mm and with a film coating, embossed “OXN” on one side and “30” on the other. NL SmPC Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg Versie Przeczytaj cały dokument