FrancophonIA/ELRC3.0 huggingface dataset:
English: The CMDh, having considered the PRAC recommendation dated 23 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Croatian: CMDh je nakon preporuke PRAC-a objavljene 23. srpnja 2014., u skladu s člankom 107.k stavcima 1. i 2. Direktive 2001/83/EZ, postigao sporazum o suspenziji odobrenja za stavljanje lijeka u promet za oralne otopine metadona koje sadrže povidon visoke molekulske mase (K90).
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for methadone medicinal products for oral use containing povidone.
Croatian: • PRAC je razmatrao postupak u skladu s člankom 107.i Direktive 2001/83/EZ za lijekove za peroralnu primjenu koji sadrže metadon i povidon;
English: • The PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml, which contains povidone K90 with an average molecular weight of 1,100,000.
Croatian: • PRAC je zabilježio da je povidon visoke molekulske mase bio prisutan samo u jednoj oralnoj otopini metadona doziranoj pri 2 mg/ml koja sadrži povidon K90 prosječne molekulske mase 1 100 000.
English: The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Croatian: PRAC je zaključio da je omjer koristi i rizika ovih lijekova povoljan pod uvjetom da su izmjene uvedene u informacije o lijeku kako bi se uskladila i ojačala poruka da su tablete samo za peroralnu primjenu i da se ne smiju injicirati.
English: • The PRAC considered that the proposed risk minimisation measures to update the product information could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90);
Croatian: • PRAC je smatrao da predložene mjere minimizacije rizika za ažuriranje informacija o lijeku nisu mogle umanjiti poznati rizik od zloporabe od strane namjenske ciljane populacije i povezanih potencijalnih ozbiljnih oštećenja koje uzrokuje injekcija povidona visoke molekulske mase (K90);
English: In the context of the review of methadone products containing povidone, the PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml (containing high molecular weight povidone, K90).
Croatian: U kontekstu procjene lijekova s metadonom koji sadrže povidon, PRAC je zabilježio da je povidon visoke molekulske mase prisutan samo u oralnoj otopini metadona u dozi od 2 mg/ml (sadržavajući 11,7 mg/ml povidona visoke molekulske mase, K90).
English: • The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Croatian: • PRAC je zaključio da je omjer koristi i rizika ovih lijekova povoljan pod uvjetom da su izmjene uvedene u informacije o lijeku kako bi se uskladila i ojačala poruka da su tablete samo za peroralnu primjenu i da se ne smiju injicirati.
English: Overall summary of the scientific evaluation of methadone products for oral use containing povidone
Croatian: Opći sažetak znanstvenog vrednovanja lijekova za peroralnu primjenu koji sadrže metadon i povidon
English: As a consequence, following the provisions under Article 107j(3) of Directive 2001/83/EC, the PRAC recommends the variation of marketing authorisations for methadone tablets containing low molecular weight povidone (K25 or K30).
Croatian: Posljedično tome, slijedeći odredbe članka 107.j stavka 3. Direktive 2001/83/EZ PRAC preporučuje izmjenu odobrenja za stavljanje u promet tableta metadona koje sadrže povidon niske molekulske mase (K25 ili K30).
English: These products are therefore not associated with the potential for harm of oral solutions containing high Mw.
Croatian: Ovi lijekovi stoga nisu povezani s potencijalom za oštećenje zdravlja koje ima oralna otopina koja sadrži povidon visoke molekulske mase.
English: As a consequence, following the provisions under Article 107j (3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Croatian: Posljedično tome, u skladu s odredbama članka 107.j stavka 3. Direktive 2001/83/EZ, PRAC preporučuje suspenziju odobrenja za stavljanje lijeka u promet za oralnu otopinu metadona koja sadrži povidon visoke molekulske mase (K90).
English: It was also noted that misuse by injection of methadone product is an inherent risk in the target population with evidence showing an occurrence of injection of methadone for oral use among injecting drug users varying from 5.0% to 79.5% (Winstock et al. 2010, Guichard et al. 2003, Waldvogel et al 2005, Judson G et al. 2010, and Vlahov D et al. 2007) and an underreporting considered to be likely.
Croatian: Također je zabilježeno da zloporaba injektiranjem lijekova koji sadrže metadon predstavlja svojstven rizik u ciljnoj populaciji s dokazom koji pokazuje učestalost injiciranja metadona za peroralnu primjenu kod intravenskih korisnika droga od 5,0 % do 79,5 % (Winstock et al.
English: 2001/83/EC the benefit risk balance of methadone oral solutions containing povidone K90 is not favourable;
Croatian: omjer koristi i rizika oralnih otopina metadona koje sadrže povidon K90 nije povoljan;
English: K30) were to be injected, it is expected to be readily excreted and not to accumulate and therefore was not associated with the potential for harm of oral solutions containing high Mw.
Croatian: • PRAC je smatrao da se u slučaju injiciranja povidona niske molekulske mase koji se nalazi u tabletama metadona (K25 ili K30) očekuje da će se povidon lako izlučiti iz organizma, a ne akumulirati te da stoga nije povezan s potencijalom za oštećenje oralnih otopina koje sadrže povidon visoke molekulske mase.
English: in addition to the acknowledged difficulty of adequately mitigate the well-known risk of misuse in the target population, the PRAC concluded that the benefits no longer outweigh the risks for methadone oral solution containing povidone K90.
Croatian: Uzimajući u obzir prijavljene ozbiljne nuspojave, uključujući i zahvaćenost koštane srži (primjerice anemija) i patološke prijelome, kao i potencijal za akumulaciju povidona visoke molekulske mase prilikom injiciranja pored prepoznate poteškoće u odgovarajućem smanjenju dobro poznatog rizika od zloporabe u ciljnoj populaciji, PRAC je zaključio da koristi više ne nadmašuju rizike za oralnu otopinu metadona koja sadrži povidon K90.
English: However, the causality of povidone deposits and bone marrow failure and skeletal fracture has been reasonably demonstrated, and the mechanism of pathophysiology appears to be related to the spatial competition of deposits and bone marrow (Kepes et al 1993; Kuo et al 1997; Dunn et al 1998; Huang et al 2012).
Croatian: Međutim, uzročna povezanost između naslaga povidona i zatajenja koštane srži te koštanog prijeloma dostatno su dokazani, a i čini se da je patofiziološki mehanizam povezan sa spacijalnim natjecanjem između naslaga i koštane srži (Kepes et al.
English: Constipation (severe
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: • 18 months.
Croatian: • 18 mjeseci.
English: Magyarország Teva Gyógyszergyár Zrt.
Croatian: Teva Gyógyszergyár Zrt.
English: TTP=time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Croatian: TTP = vrijeme do progresije bolesti; "np" pokazuje da se nije moglo procijeniti ili da još nije bilo dostignuto
English: Tumour size <2 cm >2 cm
Croatian: ≤2 cm >2 cm
English: Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Croatian: Swensweg 5, Postbus 552, 2003 RN Haarlem Nizozemska
English: Second episode: discontinue treatment.
Croatian: Druga epizoda: prekinuti liječenje
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Croatian: Liječnik će razgovarati s Vama o mogućim nuspojavama i objasniti Vam rizike i koristi liječenja.
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Croatian: Liječnik će izračunati površinu Vašeg tijela u kvadratnim metrima (m2) i odrediti dozu koji trebate primiti.
English: During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Croatian: Tijekom infuzije u bolnici mogu se javiti sljedeće vrlo česte alergijske reakcije (mogu se javiti u više od 1 na 10 osoba):
English: What Docetaxel Teva is and what it is used for
Croatian: Što je Docetaksel Teva i za što se koristi
English: Frequency not known (cannot be estimated from the available data):
Croatian: Učestalost nije poznata (ne može se procjeniti iz dostupnih podataka):
English: H-2100 Gödöllő,
Croatian: H-2100 Gödöllő, Mađarska
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba primijeniti odmah.
English: Number of patients in TAC group
Croatian: Broj bolesnika u TAC skupini
English: 2003 RN Haarlem The Netherlands
Croatian: 2003 RN Haarlem Nizozemska
English: Best overall response to study treatment
Croatian: Najbolji ukupni odgovor na liječenje tijekom studije
English: The safety and efficacy of Docetaxel Teva in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Croatian: Sigurnost primjene i djelotvornost Docetaksela Teva u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nije još ustanovljena.
English: Hazard ratio (TAC/FAC)
Croatian: Omjer rizika (TAC/FAC)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
Croatian: Datum prvog odobrenja: 26. siječanj 2010.
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Croatian: Tijekom liječenja, muškarci i žene trebaju primjenjivati kontracepcijska sredstva, a muškarci i još najmanje 6 mjeseci nakon prekida terapije (vidjeti dio 4.6).
English: Progressive disease as best overall Response (%) *Unstratified log rank test
Croatian: Progresija bolesti kao najbolji ukupni odgovor (%) * nestratificirani log-rang test
English: Date of latest renewal: 22 May 2014
Croatian: Datum posljednje obnove odobrenja: 14. srpnja 2014.
English: The estimated hazard ratio was using Cox proportional hazard model with treatment group as the factor.
Croatian: Omjer rizika procijenjen je po Cox modelu proporcionalnog rizika s liječenom skupinom kao faktorom.
English: What you need to know before you use Docetaxel Teva
Croatian: Što morate znati prije nego počnete primjenjivati Docetaksel Teva
English: How to store Docetaxel Teva Contents of the pack and other information
Croatian: Kako čuvati Docetaksel Teva Sadržaj pakiranja i druge informacije
English: Docetaxel Teva will be given by infusion into one of your veins (intravenous use).
Croatian: Docetaksel Teva ćete dobiti infuzijom u jednu od vena (intravenska primjena).
English: Median time to progression (weeks):
Croatian: Medijan vremena do progresije (tjedni)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Croatian: potreban je oprez pri istodobnom liječenju bolesnika tim lijekovima zbog mogućnosti značajne interakcije.
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Croatian: Studijska populacija uključivala je bolesnike s tehnički neoperabilnom bolešću, bolesnike s malom vjerojatnošću kirurškog izliječenja i bolesnike kod kojih se težilo očuvanju organa.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: The name of this medicine is Docetaxel Teva.
Croatian: Ovaj lijek se zove Docetaksel Teva.
English: Other medicines and Docetaxel Teva
Croatian: Drugi lijekovi i Docetaksel Teva
English: RECOMMENDATIONS FOR THE SAFE HANDLING
Croatian: PREPORUKE ZA SIGURNO RUKOVANJE
English: This medicine should not be used after the expiry date which is stated on the carton and vials after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočicama iza oznake „EXP“.
English: Before each treatment with Docetaxel Teva, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva.
Croatian: Prije svake primjene Docetaksel Teva, obavit ćete krvne pretrage kako bi se provjerilo imate li dovoljno krvnih stanica te odgovarajuću funkciju jetre kako biste mogli primiti Docetaksel Teva.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Croatian: Taj režim je primjenjivan svaka tri tjedna, tijekom 4 ciklusa u slučaju da je barem minimalni odgovor (≥ 25% smanjenje dvodimenzonalno mjerene veličine tumora) bio primijećen nakon 2 ciklusa.
English: Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Croatian: Docetaksel se ne smije primjenjivati u bolesnika s teškim oštećenjima jetre, jer o tome ne postoje dostupni podaci (vidjeti dio 4.2. i 4.4).
English: Docetaxel1 n=94
Croatian: Docetaksel1 n=94
English: Docetaxel plus trastuzumab1 n=92
Croatian: Docetaksel + trastuzumab1 n=92
English: To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Croatian: Potrebno je uzeti u obzir kod trudnica ili dojilja, djece i visokorizičnih skupina, kao što su bolesnici s bolešću jetre ili epilepsijom.
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders)
Croatian: • smanjena razina natrija, kalija, magnezija i/ili kalcija u krvi (poremećaji ravnoteže elektrolita).
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Croatian: Farmakoterapijska skupina: Antineoplastici, Taksani, ATK oznaka: L01CD 02.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docetaxel Teva may be harmful for the unborn baby.
Croatian: Ne smijete zatrudnijeti tijekom uzimanja ovog lijeka i morate provoditi učinkovite mjere kontracepcije tijekom liječenja, jer Docetaksel Teva može biti štetan za nerođeno dijete.
English: If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel which may be more severe.
Croatian: Ako ste imali alergijsku reakciju na paklitaksel, možete također doživjeti alergijsku reakciju na docetaksel, koja može biti teža.
English: ≥35 years
Croatian: ≥35 godina
English: Docetaxel Teva contains alcohol.
Croatian: Docetaksel Teva sadrži alkohol.
English: Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Croatian: Toksična smrt zabilježena je u jednog bolesnika u AT skupini (kongestivno zatajenje srca) i u 4 bolesnika u AC skupini (1 zbog septičnog šoka i 3 zbog kongestivnog zatajenja srca).
English: Overall survival was also significantly longer (p=0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Croatian: Ukupno preživljenje bilo je također značajno dulje (p=0,0201) u korist TCF skupine s rizikom smanjenja smrtnosti od 22,7%.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT water for injections
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Between infusions of Docetaxel Teva the following may occur, and the frequency may vary with the combinations of medicines that are received:
Croatian: Između infuzija Docetaksel Teva mogu se pojaviti sljedeće nuspojave, a učestalost može varirati ovisno o kombinacijama lijekova koje ste primili:
English: (26.8-ne)
Croatian: (26,8-np)
English: Concentrate and solvent for solution for infusion.
Croatian: Koncentrat i otapalo za otopinu za infuziju.
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Teva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Croatian: Od Vas će se tražiti da uzmete premedikaciju koja se sastoji od oralnih kortikosteroida, poput deksametazona, dan prije primjene Docetaksel Teva te još dan ili dva nakon toga, kako bi se smanjile određene nuspojave, koje se mogu pojaviti nakon infuzije Docetaksel Teva, osobito alergijske reakcije i zadržavanje tekućine u tijelu (oticanje ruku, stopala, nogu ili povećanje tjelesne težine).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah,vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika te ne bi smjeli biti dulji od 24 sata pri temperaturi od 2 do 8°C, osim ako se postupak razrjeđivanja proveo u kontroliranim i validiranim aseptičkim uvjetima.
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Croatian: Ako se reakcije preosjetljivosti pojave u obliku blažih simptoma, poput navale crvenila ili lokalnih reakcija na koži, to ne zahtijeva prekid terapije.
English: Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Croatian: Odzivna upalna reakcija na mjestu iniciranja (ponovna pojava kožne reakcije na mjestu prethodne ekstravazacije nakon primjene docetaksela na drugom mjestu) zapažena je na mjestu prethodne ekstravazacije (učestalost nije poznata)..
English: In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Croatian: U slučajevima teške neutropenije (< 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporučuje se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favour of the TCF arm.
Croatian: Rizik smanjenja progresije bio je 32,1% i bio je udružen sa značajnim produljenjem TTP (p=0,0004) u korist
English: • inflammation of the colon, small intestine, which could be fatal (frequency not known);
Croatian: • upala debelog crijeva, tankog crijeva, koja može biti smrtonosna (nepoznata učestalost);
English: Docetaxel Teva will be administered to you by a healthcare professional.
Croatian: Docetaksel Teva će Vam davati zdravstveni djelatnik.
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dohvata djece..
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Croatian: Sekundarni ishodi uključivali su promjenu u stupnju boli, opću procjenu kvalitete života prema EuroQoL-5D, ljestvici simptoma karcinoma pluća (Lung Cancer Symptom Scale) i promjene u
English: ≥50 years
Croatian: ≥50 godina
English: Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol (see leaflet for further information).
Croatian: Docetaksel bočica s koncentratom: polisorbat 80, bezvodni etanol (za dodatne informacije vidjeti Uputu o lijeku).
English: Reconstituted solution must be further diluted in the infusion diluent before administration.
Croatian: Rekonstituirana otopina se mora dodatno razrijediti u otopini za infuziju prije primjene.
English: A total of 1,006 patients with KPS≥60 were randomised to the following treatment groups:
Croatian: Ukupno 1006 bolesnika s KPS > 60 randomizirani su prema liječenju u sljedeće skupine:
English: Neutropenic infection
Croatian: Neutropenijska infekcija
English: In this study, 87% of patients had disease that was IHC 3+,
Croatian: U ovoj studiji 87% bolesnika imalo je IHC
English: and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Croatian: 3+, a 95% uključenih bolesnika imalo je IHC 3+ i/ili FISH pozitivne rezultate.
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p=0.0121) and a longer time to definitive worsening of Karnofsky performance status (p=0.0088) compared to patients treated with CF.
Croatian: Bolesnici liječeni s TCF imali su do 5% dulje vrijeme do definitivnog pogoršanja zdravstvenog statusa prema upitniku QLQ-C30 (p=0,0121) i dulje vrijeme do definitivnog pogoršanja prema Karnofski izvedbenom statusu (p=0,0088) u usporedbi s bolesnicima liječenim s CF.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Croatian: * omjer rizika manji od 1 ukazuje da je TAC povezan s duljim preživljenjem bez znakova bolesti i ukupnim preživljenjem u usporedbi s FAC-om
English: Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure.
Croatian: Dva bolesnika u TAC skupini i 4 bolesnika u FAC skupini umrli su od zatajenja srca.
English: Each carton contains:
Croatian: Jedno pakiranje sadrži:
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Croatian: febrilna neutropenija (uključujući neutropeniju povezanu s vrućicom i primjenom antibiotika) ili neutropenijska sepsa
English: Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Croatian: Radioterapija je provedena na megavoltažnim uređajima uz frakcioniranje jednom na dan (2 Gy na dan, 5 dana tjedno kroz 7 tjedana, u ukupnoj dozi od 70-72 Gy).