FrancophonIA/ELRC3.0 huggingface dataset:
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Croatian: preosjetljivošću na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 zatajenjem srca ili anamnezom zatajenja srca (NYHA stadiji I do IV) oštećenjem funkcije jetre dijabetičkom ketoacidozom postojećim ili preboljenim karcinomom mokraćnog mjehura neispitanom makroskopskom hematurijom.
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Croatian: često često često često često povišena kreatin fosfokinaza u krvi često povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza7
English: Takeda Belgium Tél/Tel: +32 2 464 06 11 Takeda-belgium@takeda.com
Croatian: België/Belgique/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Croatian: često (mogu se pojaviti u do 1 na 10 osoba) infekcija dišnih puteva poremećen vid povećanje tjelesne težine utrnulost manje često (mogu se pojaviti u do 1 na 100 osoba) upala sinusa (sinusitis) poteškoće sa spavanjem (nesanica)
English: - The active substance in Glustin is pioglitazone.
Croatian: Djelatna tvar Glustina je pioglitazon.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar a liječili su se lijekom Glustin i inzulinom došlo je do zatajenja srca.
English: Glustin contains lactose monohydrate
Croatian: Glustin sadrži laktozu hidrat
English: as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
Croatian: kao monoterapija - u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) u kojih se kontrola ne postiže dijetom i tjelovježbom i u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošenja kao dvojna peroralna terapija u kombinaciji s metforminom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos monoterapiji metforminom u najvećoj podnošljivoj dozi sulfonilurejom, samo u odraslih bolesnika s nepodnošenjem metformina ili u kojih je metformin kontraindiciran, s nedostatnom kontrolom glikemije usprkos monoterapiji sulfonilurejom u najvećoj podnošljivoj dozi.
English: How to store Glustin
Croatian: Kako čuvati Glustin
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Croatian: Nuspojave koje su bile zabilježene češće (˃ 0,5%) nego uz placebo ili kao izolirani slučaj u bolesnika koji su primali pioglitazon u dvostruko slijepim ispitivanjima navedene su niže prema MedDRA pojmovima, klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: Your doctor will ask you to have blood tests periodically during treatment with Glustin.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Glustin povremeno napravite krvne pretrage, da bi se provjerilo radi li Vaša jetra normalno.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Croatian: U razdoblju nakon stavljanja lijeka u promet zabilježeni su slučajevi novonastalog ili pogoršanja već postojećeg dijabetičkog makularnog edema smanjivanjem oštrine vida uz tiazolidindione, uključujući pioglitazon.
English: You can usually continue to take other medicines whilst you are being treated with Glustin.
Croatian: Za vrijeme liječenja lijekom Glustin obično možete nastaviti uzimati druge lijekove.
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Croatian: 4 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
English: Blurred vision due to swelling (or fluid) at the back of the eye has also been reported in patients taking Glustin (frequency cannot be estimated from the available data).
Croatian: U bolesnika koji uzimaju Glustin zabilježen je i zamagljen vid zbog oticanja (ili nakupljanja tekućine) na stražnjoj strani oka (učestalost se ne može procijeniti iz dostupnih podataka).
English: Bladder Cancer
Croatian: Karcinom mokraćnog mjehura
English: Takeda Oy Puh/Tel: +358 20 746 5000
Croatian: Puh/Tel: +358 20 746 5000
English: Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Glustin in combination with insulin.
Croatian: Lokalizirano oteknuće (edemi) također su vrlo često (mogu se pojaviti kod više od 1 na 10 osoba) nastajali u bolesnika koji su uzimali Glustin u kombinaciji s inzulinom.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glustin.
Croatian: Kad uzimate Glustin, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 114,51 mg laktoza hidrata (vidjeti dio 4.4).
English: Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 76,34 mg laktoza hidrata (vidjeti dio 4.4).
English: Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 92,87 mg laktoza hidrata (vidjeti dio 4.4).
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Glustin.
Croatian: Karcinom mokraćnog mjehura manje je često (može se pojaviti u do 1 na 100 osoba) nastao u bolesnika koji uzimaju Glustin.
English: Frequency of adverse reactions of pioglitazone by treatment regimen Monotherapy
Croatian: Učestalost nuspojava pioglitazona prema režimu liječenja
English: common common uncommon macular oedema not known not known not known not known not known
Croatian: često često manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato Poremećaji uha i labirinta vrtoglavica manje često
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5)
Croatian: Zabilježeno je da istovremena primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u plazmi (vidjeti dio 4.5).
English: 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Croatian: 1 Nakon stavljanja lijeka na tržište, kod bolesnika koji su liječeni pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
English: - if you have or have ever had bladder cancer.
Croatian: ako imate ili ste imali karcinom mokraćnog mjehura. ako imate krv u mokraći, a niste proveli odgovarajuće pretrage.
English: The other side effects that have been experienced by some patients taking Glustin are:
Croatian: Ostale nuspojave koje su osjetili neki bolesnici koji uzimaju
English: Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Glustin.
Croatian: Kod bolesnika koji su uzimali Glustin prijavljene su alergijske reakcije s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
English: - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
Croatian: ako imate zatajenje srca ili ste prije imali zatajenje srca. ako imate bolest jetre. ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti koja uzrokuje nagli gubitak na tjelesnoj težini, mučninu i povraćanje).
English: Glustin 30 mg tablets
Croatian: Glustin 30 mg tablete
English: Glustin 45 mg tablets
Croatian: Glustin 45 mg tablete
English: EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010 EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
Croatian: EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
English: Glustin 15 mg tablets
Croatian: Glustin 15 mg tablete
English: Each Glustin 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Glustin od 30 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
English: - Glustin 45 mg tablets are white to off-white, round, flat tablets marked “45” on one face, “AD4” on the other.
Croatian: Glustin 45 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate, s oznakom ‘45' na jednoj strani i ‘AD4' na drugoj strani.
English: Glustin 15 mg tablets Glustin 30 mg tablets Glustin 45 mg tablets
Croatian: Glustin 30 mg tablete Glustin 45 mg tablete pioglitazon
English: Each Glustin 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Glustin od 45 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
English: Each Glustin 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Glustin od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
English: Glustin 30 mg tablets are white to off-white, round, flat tablets marked “30” on one face, “AD4” on the other.
Croatian: Glustin 30 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate, s oznakom ‘30' na jednoj strani i ‘AD4' na drugoj strani.
English: EU/1/00/151/008 14 tablets EU/1/00/151/004 28 tablets EU/1/00/151/017 30 tablets EU/1/00/151/005 50 tablets EU/1/00/151/024 56 tablets EU/1/00/151/018 84 tablets EU/1/00/151/019 90 tablets EU/1/00/151/006 98 tablets
Croatian: EU/1/00/151/008 14 tableta EU/1/00/151/004 28 tableta EU/1/00/151/017 30 tableta EU/1/00/151/005 50 tableta EU/1/00/151/024 56 tableta EU/1/00/151/018 84 tableta EU/1/00/151/019 90 tableta EU/1/00/151/006 98 tableta
English: Glustin 45 mg tablets pioglitazone
Croatian: NAZIV LIJEKA Glustin 45 mg tablete pioglitazon
English: EU/1/00/151/009 14 tablets EU/1/00/151/010 28 tablets EU/1/00/151/020 30 tablets EU/1/00/151/011 50 tablets EU/1/00/151/012 56 tablets EU/1/00/151/021 84 tablets EU/1/00/151/022 90 tablets EU/1/00/151/013 98 tablets
Croatian: EU/1/00/151/009 14 tableta EU/1/00/151/010 28 tableta EU/1/00/151/020 30 tableta EU/1/00/151/011 50 tableta EU/1/00/151/012 56 tableta EU/1/00/151/021 84 tableta EU/1/00/151/022 90 tableta EU/1/00/151/013 98 tableta
English: Glustin 15 mg tablets pioglitazone
Croatian: NAZIV LIJEKA Glustin 15 mg tablete pioglitazon
English: Glustin 30 mg tablets pioglitazone
Croatian: NAZIV LIJEKA Glustin 30 mg tablete pioglitazon
English: - Glustin 15 mg tablets are white to off-white, round, convex tablets marked “15” on one face, “AD4” on the other.
Croatian: Glustin 15 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘15' na jednoj strani i ‘AD4' na drugoj strani.
English: Suomi/Finland
Croatian: Suomi/Finland Takeda Oy
English: Deutschland
Croatian: Ísland
English: EU/1/00/151/007 14 tablets EU/1/00/151/001 28 tablets EU/1/00/151/014 30 tablets EU/1/00/151/002 50 tablets EU/1/00/151/023 56 tablets EU/1/00/151/015 84 tablets EU/1/00/151/016 90 tablets EU/1/00/151/003 98 tablets
Croatian: EU/1/00/151/007 14 tableta EU/1/00/151/001 28 tableta EU/1/00/151/014 30 tableta EU/1/00/151/002 50 tableta EU/1/00/151/023 56 tableta EU/1/00/151/015 84 tableta EU/1/00/151/016 90 tableta EU/1/00/151/003 98 tableta
English: The tablets are white to off-white, round, flat and marked ‘45' on one face, ‘AD4' on the other.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘45' s jedne strane i ‘AD4' s druge strane.
English: The tablets are white to off-white, round, flat and marked ‘30' on one face, ‘AD4' on the other.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘30' s jedne strane i ‘AD4' s druge strane.
English: The tablets are white to off-white, round, convex and marked ‘15' on one face, ‘AD4' on the other.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘15' s jedne strane i ‘AD4' s druge strane.
English: Glustin 30 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Glustin 30 mg
English: Glustin 45 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Glustin 45 mg
English: EU/1/00/151/001 EU/1/00/151/002
Croatian: EU/1/00/151/001 EU/1/00/151/002 EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010
English: Sun.
Croatian: C.
English: Package leaflet: Information for the patient Glustin 15 mg tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Glustin 15 mg tablete
English: Glustin 15 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Glustin 15 mg
English: 56 capsules
Croatian: 56 kapsula
English: EU/1/15/1075/001
Croatian: EU/1/15/1075/001 Feraccru
English: 30 mg Capsule, hard Oral use bottle (HDPE)
Croatian: 30 mg Kapsula, tvrda Peroralna primjena Bočica (HDPE)
English: EU (MA) Number
Croatian: EU (MA) broj
English: 26 July 2013
Croatian: 26. srpnja 2013.
English: It has been authorised in the European Union since 4 April 2008.
Croatian: Odobren je u Europskoj uniji od 4. travnja 2008. godine.
English: The withdrawal letter is available here.
Croatian: Dopis o povlačenju zahtjeva dostupan je ovdje.
English: The full European Public Assessment Report for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelokupno Europsko javno izvješće o ocjeni dokumentacije o lijeku za Effentora možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako ste uključeni u kliničko ispitivanje te Vam je potrebno više informacija o Vašem liječenju, obratite se liječniku koji Vam pruža liječenje.
English: In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
Croatian: U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u intenzitetu boli u roku od 60 minuta nakon uzimanja tablete.
English: Each patient ranked their pain intensity on a scale of 0 to 10.
Croatian: Svaki je bolesnik rangirao intenzitet boli na skali od 0 do 10.
English: It is a well-known substance, which has been used to control pain for many years.
Croatian: Ovo je vrlo dobro poznata tvar, koja se koristi već dugi niz godina za kontrolu boli.
English: The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Croatian: Trajanje liječenja utvrđeno je vremenom potrebnim da svaki bolesnik kontrolira 9 epizoda prodorne boli unutar razdoblja od 21 dan.
English: In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
Croatian: U svojem službenom dopisu, tvrtka je navela da je odlučila povući zahtjev nakon što je CHMP naveo da dostavljeni podaci nisu dostatni za odstranjivanje zabrinutosti Povjerenstva.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Croatian: Tvrtka je obavijestila CHMP da ovo nema posljedica za bolesnike koji su trenutno uključeni u klinička ispitivanja s lijekom Effentora.
English: The active substance in Effentora, fentanyl, is an opioid.
Croatian: Djelatna tvar u Effentora, fentanil, je opioid.
English: What consequences does this withdrawal have for patients in clinical trials?
Croatian: Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: There are no consequences on the use of Effentora in its authorised indication.
Croatian: Nema posljedica za korištenje lijeka Effentora u odobrenoj indikaciji.
English: The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Croatian: Djelovanje lijeka Effentora uspoređeno je s djelovanjem placebo lijeka (lažnog liječenja) u 79 bolesnika s neuropatskom boli (boli zbog oštećenja živca) u jednom ispitivanju, i u 77 bolesnika s boli u donjem dijelu leđa u drugom ispitivanju.
English: Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Croatian: Lijek Effentora dostupan je u obliku „bukalnih tableta“ (tableta koje se otapaju u ustima).
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila te sastavio popis pitanja.
English: Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Croatian: Nakon što se apsorbira, fentanil djeluje na receptore u mozgu i leđnoj moždini kako bi se kontrolirala bol.
English: What was Effentora expected to be used for?
Croatian: Za što se Effentora trebao koristiti?
English: On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Croatian: Dana 11. srpnja 2013. godine, Teva Pharma B.V. službeno je obavijestio Povjerenstvo za humane lijekove (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje lijeka u promet zbog nove indikacije za lijek Effentora da bi proširio liječenje za prodornu bol u odraslih bolesnika s kroničnom (dugoročnom) perzistirajućom boli prouzročenom drugim uzrocima osim rakom.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su uvijek postojale neke nedoumice.
English: The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Croatian: Trećim ispitivanjem, koje je trajalo 12 tjedana, ispitano je djelovanje lijeka Effentora u 148 bolesnika s dugoročnom boli koja nije povezana s rakom.
English: How was Effentora expected to work?
Croatian: Kako je Effentora trebao djelovati?
English: What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Croatian: Što se događa s lijekom Effentora kada je riječ o liječenju „prodorne“ boli u odraslih osoba oboljelih od raka?
English: The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Croatian: Podnositelj zahtjeva dostavio je podatke iz 3 glavna ispitivanja provedena u odraslih osoba s prodornom boli koji već koriste opioide.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Croatian: Prodorna bol nastupa kada bolesnik osjeti dodatnu, iznenadnu bol usprkos neprekidnom liječenju analgeticima.
English: It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Croatian: Već se koristi za liječenje „prodorne“ boli u odraslih osoba oboljelih od raka, koji koriste opioidne analgetike za kontrolu dugoročne boli uzrokovane rakom.
English: The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Croatian: Povjerenstvo je također iskazalo zabrinutost budući da su pacijenti obuhvaćeni ispitivanjima imali visoke razine pozadinske boli, a postoji mogućnost da nisu bili reprezentativni za predviđenu terapijsku grupu, koja se sastoji od bolesnika s prodornom boli, no čija se pozadinska bol može dobro regulirati redovnim liječenjem opioidima.
English: In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
Croatian: U odraslih osoba s dugotrajnom boli prouzročenom drugim uzrocima osim rakom, Effentora je trebao djelovati na isti način kao i u odraslih osoba s boli uzrokovanom rakom.
English: The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
Croatian: CHMP je smatrao da, iako je uporaba lijeka Effentora prihvaćena u bolesnika oboljelih od raka koji imaju ograničene izglede za preživljavanje, su potrebni daljnji podaci u prilog sigurne uporabe lijeka u odraslih osoba s boli koja nije povezana s rakom, a koji imaju normalno očekivano trajanje života te mogu imati potrebe za dugotrajnim liječenjem.
English: Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Croatian: Effentora se trebao koristiti za liječenje prodorne boli u odraslih osoba s dugoročnom perzistirajućom boli prouzročenom drugim uzrocima osim rakom, koji su već prethodno primali redovno liječenje opioidima za kontrolu njihove perzistirajuće boli.