FrancophonIA/ELRC3.0 huggingface dataset:
English: Polyvinylchloride bag containing 200 ml of solvent in individual over-pouch.
Croatian: Vrećica od polivinilklorida koja sadrži 200 ml otapala u pojedinačnom paketiću.
English: Active substance:
Croatian: Potkožna primjena:
English: (ml)
Croatian: Ltd.
English: Polyvinylchloride bag containing 800 ml of solvent in individual over-pouch.
Croatian: Vrećica od polivinilklorida koja sadrži 800 ml otapala u pojedinačnom paketiću.
English: Polyvinylchloride bag containing 400 ml of solvent in individual over-pouch.
Croatian: Vrećica od polivinilklorida koja sadrži 400 ml otapala u pojedinačnom paketiću.
English: Sterile solvent
Croatian: Sterilno otapalo
English: Glass ampoule of 1,000; 2,000 or 4,000 doses of the vaccine.
Croatian: (Ampule od 1.000, 2.000 ili 4.000 doza) NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: Further information on Aranesp's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Dodatne informacije o trenutačnim primjenama lijeka Aranesp nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was a reduction in the number of transfusions of red blood cells.
Croatian: Glavna mjera učinkovitosti bilo je smanjenje broja transfuzija eritrocita.
English: The CHMP was of the opinion that changes to the study design of one study and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.
Croatian: CHMP je smatrao da promjene u konceptu jednog ispitivanja i isključivanje velikog broja bolesnika iz analize rezultata dovode u pitanje valjanost podataka.
English: This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
Croatian: To znači da darbepoetin alfa djeluje dulje pa se može davati rjeđe nego prirodni eritropoetin.
English: In addition, one study conducted in the United States was not in line with EU recommendations for treatment of patients with myelodysplastic syndromes.
Croatian: Osim toga, jedno ispitivanje provedeno u Sjedinjenim Američkim Državama nije bilo u skladu s preporukama EU-a za liječenje bolesnika s mijelodisplastičnim sindromima.
English: On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.
Croatian: Dana 21.veljače 2018. tvrtka Amgen Europe B.V. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za dodavanje liječenja anemije u odraslih bolesnika s mijelodisplastičnim sindromima postojećem odobrenju za stavljanje lijeka u promet.
English: The applicant presented data from two main studies in 356 anaemic patients with myelodysplastic syndromes.
Croatian: Podnositelj zahtjeva predstavio je podatke iz dva glavna ispitivanja na 356 anemičnih bolesnika s mijelodisplastičnim sindromima.
English: What is Aranesp?
Croatian: Što je Aranesp?
English: The medicine was to be used in patients who did not need frequent blood transfusions and who had a low or intermediate risk of their condition progressing to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells).
Croatian: Lijek se trebao koristiti u bolesnika koji nisu trebali česte transfuzije krvi i u kojih je postojao nizak ili umjeren rizik od pogoršanja stanja do akutne mijeloične leukemije (AML, vrste karcinoma koji zahvaća bijele krvne stanice).
English: • adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
Croatian: • odraslih koji primaju kemoterapiju za „nemijeloidni karcinom” (karcinom koji ne potječe iz koštane srži).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
Croatian: EMA/165563/2018 EMEA/H/C/000332
English: • adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Croatian: • odraslih i djece s „kroničnim zatajenjem bubrega” (dugotrajne, progresivne bolesti koja narušava sposobnost pravilnog rada bubrega)
English: The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks.
Croatian: U prvom ispitivanju lijek Aranesp uspoređen je s placebom (prividnim liječenjem) tijekom 24 tjedna.
English: Aranesp is a medicine already used to treat anaemia (low red-blood-cell count) that is causing symptoms in the following groups of patients:
Croatian: Aranesp je lijek koji se već koristi za liječenje anemije (niske razine crvenih krvnih stanica) koja uzrokuje simptome u sljedećih skupina bolesnika:
English: What is happening with Aranesp in its authorised uses?
Croatian: Što se događa s lijekom Aranesp kada je riječ o odobrenim primjenama?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not considered to be reliable and the Committee concluded that the change to the use of the medicine could not have been approved based on the data presented by the company.
Croatian: Stoga je u vrijeme povlačenja zahtjeva CHMP smatrao da se rezultati ispitivanja ne mogu smatrati pouzdanima i Odbor je zaključio da se promjena u pogledu uporabe lijeka ne može odobriti na temelju podataka koje je dostavila tvrtka.
English: What was Aranesp expected to be used for?
Croatian: Za što se Aranesp trebao koristiti?
English: In the second study, all patients received Aranesp for 13 weeks and the study measured the level of haemoglobin, the main constituent of red blood cells, in the blood.
Croatian: U drugom ispitivanju svi su bolesnici primali lijek Aranesp tijekom 13 tjedana, a tijekom ispitivanja mjerena je razina hemoglobina, glavnog sastojka eritrocita u krvi.
English: Aranesp, acts exactly like a natural hormone called erythropoietin that is made by the kidneys to stimulate red blood cell production, but it is very slightly different in its structure.
Croatian: Aranesp, djeluje točno poput prirodnog hormona eritropoetina koji stvaraju bubrezi kako bi stimulirali produkciju eritrocita, ali postoji mala razlika u njihovim strukturama.
English: In the treatment of anaemia in patients with myelodysplastic syndromes, Aranesp was expected to work in the same way as it does in its existing indications.
Croatian: Očekivalo se da će u liječenju anemije u bolesnika s mijelodisplastičnim sindromima Aranesp djelovati na isti način kao što djeluje u svojim postojećim indikacijama.
English: Darbepoetin alfa, the active substance in
Croatian: Darbepoetin alfa, djelatna tvar u lijeku
English: There are no consequences for the use of Aranesp in its authorised uses.
Croatian: Nema posljedica na primjenu lijeka Aranesp za odobrene primjene.
English: Aranesp was also expected to be used to treat anaemia in patients with myelodysplastic syndromes, a group of bone marrow disorders.
Croatian: Očekivalo se također da će se Aranesp koristiti za liječenje anemije u bolesnika s mijelodisplastičnim sindromima, skupini poremećaja koštane srži.
English: By acting in the same way as erythropoietin, Aranesp stimulates the body to make more red blood cells and so treats anaemia.
Croatian: Djelujući na isti način kao i eritropoetin, Aranesp stimulira tijelo da proizvodi više eritrocita te tako liječi anemiju.
English: How does Aranesp work?
Croatian: Kako djeluje Aranesp?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aranesp could not have been approved for the treatment of anaemia in adult patients with myelodysplastic syndromes.
Croatian: Na temelju pregleda podataka u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Aranesp za liječenje anemije u odraslih bolesnika s mijelodisplastičnim sindromima.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on the CHMP's opinion that the data provided do not allow the Committee to authorise use in myelodysplastic syndromes.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela kako povlači zahtjev zbog mišljenja CHMP-a da izneseni klinički podatci ne omogućuju Odboru da odobri uporabu lijeka u slučaju mijelodisplastičnih sindroma.
English: Aranesp has been authorised since June 2001.
Croatian: Lijek Aranesp odobren je od lipnja 2001. Sadržava djelatnu tvar darbepoetin alfa.
English: The company informed the Agency that there are no Amgen-sponsored ongoing clinical trials with Aranesp.
Croatian: Tvrtka je obavijestila Agenciju da nema posljedica za bolesnike koji su uključeni u klinička ispitivanja koje naručuje Amgen, a u kojima se koristi lijek Aranesp.
English: It contains the active substance darbepoetin alfa.
Croatian: Povlačenje zahtjeva za izmjenu odobrenja za stavljanje u promet lijeka Aranesp (darbepoetin alfa)
English: The children's age ranged from 17 days to 6 years.
Croatian: Dob djece varirala je od 17 dana do šest godina.
English: The timetable for the implementation of the agreement is set out in Annex IV.
Croatian: Raspored primjene sporazuma određen je u Prilogu IV.
English: A review of these cases indicated that, four cases had a fatal outcome.
Croatian: Pregledom navedenih slučajeva pokazalo se da su četiri slučaja imala smrtni ishod.
English: The remaining cases were all life-threatening but resulted in full recovery.
Croatian: Preostali slučajevi bili su opasni po život, ali je došlo do potpunog oporavka.
English: In such clinical settings it is not expected that codeine use brings any significant benefit, while the risks identified can be of serious consequences.
Croatian: U takvim kliničkim uvjetima ne očekuje se da uporaba kodeina donosi veliku korist, dok utvrđeni rizici mogu predstavljati rizike od ozbiljnih posljedica.
English: Therefore, this continues to represent a variable safety risk across all paediatric age groups.
Croatian: To stoga ostaje promjenjiv sigurnosni rizik u svim dobnim skupinama pedijatrijske populacije.
English: Individuals are normally classified as poor (PM), extensive (EM) or ultrarapid metabolisers (UM), depending on the activity of the enzyme.
Croatian: Osobe se uobičajeno klasificiraju kao slabi (PM), ekstenzivni (EM) ili vrlo brzi metabolizatori (UM), ovisno o aktivnosti enzima.
English: Overall, the majority (38/50) of the cases were in patients younger than 12 years of age and 6 were fatal cases.
Croatian: Općenito govoreći, u većini slučajeva (38/50) bila je riječ o pacijentima mlađima od 12 godina, a šest je slučajeva završilo smrtnim ishodom.
English: The PRAC also considered data from the European Pharmacovigilance database (Eudravigilance), a drug utilisation study of the patterns of prescription of codeine and performed a consultation with European healthcare professional organisations and with the Paediatric Committee (PDCO).
Croatian: PRAC je također uzeo u obzir podatke iz europske farmakovigilancijske baze podataka (Eudravigilance), ispitivanja obrazaca propisivanja kodeina u ispitivanjima uporabe lijeka te je proveo savjetovanje s europskim liječničkim organizacijama i Pedijatrijskim odborom (PDCO).
English: Data analyses from the Eudravigilance database identified a total of 50 case reports that could be related to opiate toxicity, of which 31 cases were in those younger than 6 years (including 4 fatal cases), 7 cases in older than 6 years and younger than 12 years (including 1 fatal case) and the remaining 12 cases were on those older than 12 and younger than 18 years (including 1 fatal case).
Croatian: Analizama podataka iz baze podataka Eudravigilance utvrđeno je ukupno 50 prijavljenih slučajeva koji bi mogli biti povezani s opioidnom toksičnošću; u 31 slučaju pacijenti su bili mlađi od šest godina (uključujući četiri smrtna slučaja), u sedam slučajeva pacijenti su bili stariji od šest godina i mlađi od 12 godina (uključujući jedan smrtni slučaj) te u preostalih 12 slučajeva pacijenti su bili stariji od 12 godina i mlađi od 18 godina (uključujući jedan smrtni slučaj).
English: Codeine is converted into morphine in the body by cytochrome P450 2D6 (CYP2D6), an enzyme which shows genetic polymorphism.
Croatian: Kodein se u tijelu pretvara u morfin zahvaljujući citokromu P450 2D6 (CYP2D6), enzimu koji pokazuje genetički polimorfizam.
English: Treatment guidelines recommend treatment of persistent chronic cough in paediatric patients based on aetiology.
Croatian: U smjernicama za liječenje preporučuje se liječenje upornog kroničnog kašlja u pedijatrijskih pacijenata koje se temelji na etiologiji.
English: Cough is a reflex response to mechanical, chemical, or inflammatory irritation of the tracheobronchial tree.
Croatian: Kašalj je refleksna reakcija na mehaničku, kemijsku ili upalnu iritaciju traheobronhalnog stabla.
English: The risk of opioid toxicity is especially pronounced among UMs due to its serious consequences of respiratory depression.
Croatian: Rizik od opioidne toksičnosti osobito je naglašen među vrlo brzim metabolizatorima zbog ozbiljnih posljedica u obliku respiratorne depresije.
English: However, there is little clinical data in the medical literature to support the efficacy of codeine in the
Croatian: Međutim, u liječničkoj literaturi postoji malo kliničkih podataka kojima bi se potkrijepila učinkovitost kodeina u
English: A review of serious and fatal cases in paediatric patients from the literature, global pharmacovigilance databases and regulatory authorities suggests that the respiratory depressant effects of codeine may influence the occurrence of respiratory complications.
Croatian: Ocjena ozbiljnih i smrtnih slučajeva u pedijatrijskih pacijenata iz literature, globalnih farmakovigilancijskih baza podataka i zakonodavnih tijela ukazuje na to da učinci kodeina u obliku respiratorne depresije mogu utjecati na pojavu respiratornih komplikacija.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for codeine containing medicinal products for the treatment of cough and/or cold in children.
Croatian: • PRAC je razmotrio postupak u skladu s člankom 31. Direktive 2001/83/EZ koji proizlazi iz podataka o farmakovigilanciji za proizvode koji sadržavaju kodein za liječenje kašlja i/ili prehlade u djece.
English: The large majority of childhood respiratory infections with cough are caused by viral infections, which are self-limiting and only last for a few days whereas in the case of chronic cough, treatment should be directed at the underlying disease2,3 (American Academy of Paediatrics Committee on Drugs 1997, American Academy of Paediatrics, AAP publications retired or reaffirmed 2006).
Croatian: Velika većina respiratornih infekcija u djece popraćena kašljem prouzročena je virusnim infekcijama, koje su samoograničavajuće i koje traju samo nekoliko dana, dok bi se u slučajevima kroničnog kašlja liječenje trebalo usredotočiti na uzročnu bolest2,3 (Američka akademija Pedijatrijskog odbora za lijekove 1997., Američka pedijatrijska akademija, publikacije Američke pedijatrijske akademije koje su povučene ili 2006. godine ponovno potvrđene).
English: 1 Article 31 pharmacovigilance referral for codeine used for management of pain in paediatric patients (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f symptomatic treatment of cough and/or cold as current evidence does not find codeine to be more effective than placebo for acute cough in children.
Croatian: 1 Upućivanje na farmakovigilanciju na temelju članka 31. za kodein koji je upotrijebljen za ublažavanje boli u pedijatrijskih pacijenata (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f simptomatskom liječenju kašlja i/ili prehlade jer postojeći dokazi ne pokazuju da je za liječenje akutnog kašlja u djece kodein učinkovitiji od placeba.
English: Apart from its use as an analgesic for relief of pain, it is also used for the symptomatic treatment of cough and/or cold.
Croatian: Osim što se upotrebljava kao analgetik za ublažavanje boli, kodein se upotrebljava i za simptomatsko liječenje kašlja i/ili prehlade.
English: However, the CMDh considered that in view of the recommended contra indication of the use of codeine for cough and/or cold in children below 12 years of age, some marketing authorisations may have to be revoked.
Croatian: Međutim, CMDh je smatrao da bi, imajući na umu preporučene kontraindikacije uporabe kodeina za liječenje kašlja i/ili prehlade u djece mlađe od 12 godina, neka odobrenja za stavljanje lijeka u promet mogla biti opozvana.
English: Further to consideration of all data available at that time, the PRAC concluded that codeine remained an effective analgesic for the treatment of acute moderate pain in children above 12 years of age which is not considered to be relieved by other analgesics.
Croatian: Daljnjim razmatranjem svih dostupnih podataka PRAC je zaključio da kodein ostaje učinkovit analgetik za liječenje akutne umjerene boli u djece starije od 12 godina za koju se smatra da je ostali analgetici ne ublažavaju.
English: A randomised clinical trial (Jaffe G et al, 1983) and an epidemiological study (De Blasio F et al, 2012) did not show a significant effect of the treatment with codeine in cough and/or cold in children.
Croatian: U randomiziranom kliničkom ispitivanju (Jaffe G et al, 1983.) i epidemiološkom ispitivanju (De Blasio F et al, 2012.) nije dokazan znatan učinak liječenja kodeinom kašlja i/ili prehlade u djece.
English: Therefore, the marketing authorisation holders of codeine containing medicinal products in oral formulations should discuss with the National Competent Authorities in the Member States the applicability of this minimisation measure in their territory.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet lijekova koji sadržavaju kodein u obliku za oralnu primjenu trebali bi stoga s nacionalnim nadležnim tijelima u državama članicama raspraviti o primjenjivosti mjera smanjenja rizika na svojem području.
English: The symptoms of morphine toxicity may be increased in these settings.
Croatian: U navedenim okolnostima simptomi trovanja morfinom mogli bi se pojačati.
English: Codeine suppresses the cough reflex through a direct effect on the cough centre in the medulla.
Croatian: Kodein zaustavlja refleks kašlja izravnim djelovanjem na centar za kašalj u moždini.
English: The unpredictable and variable metabolism of codeine in children, governed by CYP2D6 polymorphism, may cause some children to exhibit morphine-related serious adverse events such as breathing difficulties or respiratory depression even within the recommended doses.
Croatian: Nepredvidljiv i promjenjiv metabolizam kodeina u djece, kojim upravlja polimorfni enzim CYP2D6, u neke djece može prouzročiti ozbiljne nuspojave povezane s morfinom kao što su poteškoće s disanjem ili respiratorna depresija, čak i u preporučenim dozama.
English: Whereas EMs or UMs are at risk of morphine toxicity, PMs may be at an increased risk of a lack of therapeutic effect.
Croatian: Dok su metabolizatori EM ili UM u opasnosti od trovanja morfinom, metabolizatori PM mogu imati povećan rizik od nedostatka terapijskog učinka.
English: Pediatrics 2007;119(2):405.
Croatian: AAP Publications Retired or Reaffirmed, October 2006. Pediatrics 2007;119(2):405.
English: Codeine, also known as methylmorphine, binds to µ-opioid receptors to produce analgesia and euphoria, as well as respiratory depression, miosis, and reduced gastric motility.
Croatian: Kodein, poznat i pod nazivom metilmorfin, veže se na µ-opioidne receptore kako bi prouzročio analgeziju i euforiju, kao i respiratornu depresiju, miozu te smanjenu želučanu pokretljivost.
English: Therefore, in addition to the PRAC recommendation to vary the marketing authorisations, the CMDh also agreed that if a marketing authorisation cannot be varied in line with the terms of the CMDh agreement, member states may consider the revocation of that marketing authorisation.
Croatian: Stoga, osim s preporukom PRAC-a za izmjenu odobrenja za stavljanje lijeka u promet, CMDh se složio da u slučajevima kada odobrenje za stavljanje lijeka u promet nije moguće izmijeniti prema zaključcima CMDh-a, države članice mogu razmotriti opoziv tog odobrenja za stavljanje lijeka u promet.
English: The PRAC took into account that the enzymatic systems responsible for the metabolism of codeine in children older than 12 years of age can be considered comparable to that of adults.
Croatian: PRAC je uzeo u obzir činjenicu da bi se enzimski sustav koji je odgovoran za metabolizam kodeina u djece starije od 12 godina mogao smatrati usporedivim s enzimskim sustavom odraslih osoba.
English: The PRAC reviewed all available data from different sources: clinical trials, observational studies, metaanalyses, post-marketing data and further published literature data on the use of codeine containing products in children for treatment of cough and/or cold.
Croatian: PRAC je pregledao sve dostupne podatke iz različitih izvora: kliničkih ispitivanja, studija promatranja, metaanaliza, podatke nakon izdavanja odobrenja za stavljanje lijeka u promet i podatke iz dodatnih objavljenih izvora o primjeni proizvoda koji sadržavaju kodein u djece za liječenje kašlja i/ili prehlade.
English: The CMDh, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and agreed that the marketing authorisation(s) for should be revoked or varied, as applicable.
Croatian: Nakon što je razmotrio preporuku PRAC-a, CMDh se slaže s općim znanstvenim zaključcima PRAC-a i donio je zaključak da odobrenje(a) za stavljanje lijeka u promet treba prema potrebi opozvati ili izmijeniti.
English: Therefore, whenever reference to codeine is made in these SmPC sections and the product is a combination of codeine and other active substances, the wording is amended to include the invented name of these products instead of the INN “codeine”.
Croatian: Stoga se pri svakom upućivanju na kodein u tim dijelovima sažetaka opisa svojstava lijeka, kada je proizvod kombinacija kodeina i ostalih aktivnih tvari, tekst izmjenjuje kako bi uključio izmišljen naziv tih lijekova umjesto popisa međunarodnih nezaštićenih imena „kodein”.
English: All codeine containing medicinal products approved for the treatment of cough and/or cold in paediatric population, including single and combination products authorised in the European Union are included in this review.
Croatian: U tu ocjenu uključeni su svi lijekovi koji sadržavaju kodein, a koji su odobreni za liječenje kašlja i/ili prehlade u pedijatrijskoj populaciji, uključujući jedinstvene i kombinirane proizvode koje je odobrila Europska unija.
English: The present referral under Article 31 of Directive 2001/83/EC concerns the use of codeine in paediatric patients for the cough and/or cold indications as triggered on 02 April 2014 by the German National Competent Authority (BfArM) due to the applicability of the above risk measures also to these indications.
Croatian: U trenutačnom upućivanju na temelju članka 31. Direktive 2001/83/EZ razmatra se uporaba kodeina u pedijatrijskih pacijenata koja je indicirana za kašalj i/ili prehladu, a pokrenulo ga je 2. travnja 2014. njemačko nacionalno nadležno tijelo (BfArM) zbog primjenjivosti prethodno navedenih mjera rizika i na te indikacije.
English: Efficacy data is therefore limited, with no recent and well-established controlled scientific studies to clearly support the benefit of codeine in the approved indications for cough and/or cold for the paediatric population.
Croatian: Podaci o učinkovitosti stoga su ograničeni te ne postoje detaljna kontrolirana znanstvena ispitivanja koja bi jasno potkrijepila korist kodeina u odobrenim indikacijama za liječenje kašlja i/ili prehlade u pedijatrijskoj populaciji.