FrancophonIA/ELRC3.0 huggingface dataset:
English: The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
Croatian: Drugo je ispitivanje usporedilo monoterapiju lijekom Norvir, zidovudinom (drugim antivirotikom) koji se uzimao kao monoterapija i kombinaciju lijeka Norvir i zidovuduina u 356 odraslih osoba koje prije nisu uzimale terapiju za infekciju HIV-om.
English: When it is used as a booster, the side effects of Norvir depend on the other antiviral medicine being taken.
Croatian: Ako se koristi kao „booster“, nuspojave lijeka Norvir ovise o drugim antiviroticima koji se uzimaju.
English: For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni lijeka Norvir potražite u uputi o lijeku.
English: Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Croatian: Norvir, u kombinaciji s drugim antiviroticima, također je smanjio virusno opterećenje u djece.
English: For more information, see the package leaflet provided with the other medicine.
Croatian: Za dodatne informacije vidjeti uputu o lijeku koja se isporučuje s drugim lijekovima.
English: The full EPAR for Norvir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Norvir nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Norvir pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Croatian: Norvir je ispitivan kao „booster“u kliničkim ispitivanjima kojima se treba ocijeniti djelovanje antivirotika koja on pojačava.
English: What is Norvir used for?
Croatian: Za što se Norvir koristi?
English: What benefit has Norvir shown during the studies?
Croatian: Koje su koristi lijeka Norvir utvrđene u ispitivanjima?
English: How does Norvir work?
Croatian: Kako djeluje Norvir?
English: How is Norvir used?
Croatian: Kako se Norvir koristi?
English: How has Norvir been studied?
Croatian: Kako je Norvir ispitivan?
English: 1.850 GBq/ml Radiopharmaceutical precursor
Croatian: 1,850 GBq/ml
English: Invented name Strength Pharmaceutical form
Croatian: Farmaceutski oblik
English: Vial (glass)
Croatian: Radiofarmaceutski prekursor Bočica (staklena)
English: MA (EU) number (Invented)
Croatian: MA (EU) broj
English: Methadone is a synthetic opioid.
Croatian: Metadon je sintetički opijat.
English: Most of the patients were currently or previously included in OST programs.
Croatian: Većina bolesnika bila je prethodno ili trenutno uključena u OST programe.
English: • The PRAC considered the proportionate response to the evidence of harm.
Croatian: • PRAC je razmatrao proporcionalan odgovor na dokaz o štetnosti.
English: Therefore, the PRAC recommends the suspension of this product.
Croatian: Stoga je PRAC preporučio suspenziju ovog lijeka.
English: The timetable for the implementation of the agreement is set out in Annex V.
Croatian: Raspored provedbe sporazuma određen je u Dodatku V.
English: For the other three patients, this information was lacking.
Croatian: Ova informacija nije bila dostupna za ostala tri bolesnika.
English: This leads to ‘povidone storage disease' that may cause serious harm.
Croatian: To uzrokuje „bolest pohrane povidona” koji može uzrokovati ozbiljno oštećenje.
English: • Based on the available data, the PRAC concluded, that pursuant to Article 116 of Directive
Croatian: • Na temelju dostupnih podataka PRAC je zaključio da u skladu s člankom 116.
English: The review took into account 15 cases of serious adverse reactions reported in Norway.
Croatian: Procjena je obuhvatila 15 slučajeva ozbiljnih nuspojava prijavljenih u Norveškoj.
English: The condition for lifting the suspension of these marketing authorisations is set out in Annex IV.
Croatian: Uvjet za ukidanje suspenzije ovih odobrenja za stavljanje u promet opisan je u Dodatku IV.
English: However, available data do not demonstrate the effectiveness of povidone in mitigating this risk.
Croatian: Međutim, dostupni podatci ne pokazuju djelotvornost povidona u smanjivanju ovog rizika.
English: Supervised administration of every dose was also discussed but this would be difficult to consistently incorporate into daily OST practice and would lead to serious non-compliance.
Croatian: Također se raspravljalo o nadziranoj primjeni svake doze, ali to bi bilo teško dosljedno inkorporirati u dnevnu OST praksu te bi uzrokovalo ozbiljno nepridržavanje.
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Croatian: Za ukidanje suspenzije, nadležna nacionalna tijela država članica trebaju potvrditi da je nositelj odobrenja ispunio sljedeće uvjete:
English: For 12 of the 15 patients, evidence that they had been prescribed or used methadone (urine sample or patient's statement) was available.
Croatian: Za 12 od 15 bolesnika bio je dostupan dokaz da im je bio propisan metadon ili da su koristili metadon (uzorak urina ili bolesnikova izjava).
English: Fourteen (14) cases of renal failure were reported.
Croatian: Prijavljeno je četrnaest (14) slučajeva zatajenja bubrega.
English: The cases concerned former or current injecting drug abusers, aged 24 to 53 years old.
Croatian: Dotični slučajevi ticali su se sadašnjih intravenskih korisnika droga koji su zlorabili lijek injektiranjem, u dobi od 24 do 53 godine.
English: Additional warnings in the label were further considered, but a direct information to the patients is challenging and according to the experts, such measures are unlikely to further minimise the risk of injection.
Croatian: Razmatrana su dodatna upozorenja na naljepnici, ali izravna informacija za bolesnika i dalje je izazov te prema mišljenju stručnjaka nije vjerojatno da će takve mjere nadalje smanjiti rizik od injekcije.
English: Treatment with methadone should be given in the context of a wider rehabilitation program, opioid substitution therapy (OST).
Croatian: Terapiju metadonom treba davati u kontekstu šireg programa rehabilitacije i terapije nadomještanjem opijatima (OST).
English: The inclusion of povidone K90 in oral methadone solutions was initially intended to enhance viscosity and reduce the risk of misuse by injection.
Croatian: Uključivanje povidona K90 u oralne otopine metadona u početku je bilo namijenjeno za povećavanje viskoznosti i smanjivanje rizika od zloporabe injekcije.
English: The PRAC noted that all these 15 cases reported “intentional drug misuse”, “product deposit” and “drug administered via inappropriate route” and were assessed by the regional pharmacovigilance centre in Norway as possibly or probably related to the injection of povidone.
Croatian: PRAC je zabilježio da je svih 15 slučajeva prijavilo „namjernu zloporabu lijeka”, „deponiranje lijeka” i „primjenu lijeka pogrešnim načinom” te su bili procijenjeni u regionalnom centru za farmakovigilanciju u Norveškoj kao moguće ili vjerojatno povezane s injekcijom povidona.
English: The efficacy of methadone in OST was acknowledged in this referral procedure.
Croatian: Djelotvornost metadona u OST potvrđena je u ovom arbitražnom postupku.
English: The overall effectiveness of methadone maintenance treatment is established in the literature and has been reviewed in several articles.
Croatian: Ukupna djelotvornost terapije održavanja metadonom utvrđena je u literaturi te je proučavana u nekoliko članaka.
English: Available data from the scientific literature suggests that an association between deposits of povidone and renal impairment has not been well established.
Croatian: Dostupni podatci iz znanstvene literature ukazuju na to da povezanost između naslaga povidona i oštećenja bubrega nije jasno utvrđena.
English: For one of the five patients the bone marrow biopsy showed about 90% histiocytic infiltration characteristic for povidone deposit and only about 5% of bone marrow available for erythropoiesis.
Croatian: Za jednog od pet bolesnika biopsija koštane srži pokazala je da oko 90 % histiocističnih karakteristika infiltracije histiocita za depozite povidona i samo oko 5 % koštane srži dostupne za eritropoezu.
English: The review of oral methadone medicines containing povidone started on 10 April 2014 under Article 107i of Directive 2001/83/EC.
Croatian: Procjena lijekova za peroralnu primjenu koji sadrže metadon i povidon počela je 10. travnja 2014 u skladu s člankom 107.i Direktive 2001/83/EZ.
English: Should this oral solution be repeatedly injected, povidone would be permanently retained and accumulate within organs and tissues, leading to potential serious harm.
Croatian: Ako se ova oralna otopina opetovano injicira povidon će se trajno zadržati i akumulirati unutar organa i tkiva te uzrokovati potencijalno ozbiljno oštećenje.
English: The product information of this methadone oral solution already contains clear advice that it should not be injected.
Croatian: Informacije o oralnim otopinama metadona već sadrže jasan savjet da se lijek ne smije injicirati.
English: In all cases, staining of biological samples supports the conclusion that povidone accumulated in the affected organs.
Croatian: U svim slučajevima bojanje bioloških uzoraka podržalo je zaključak da se povidon akumulira u zahvaćenim organima.
English: Six kidney biopsies were presented and all demonstrated deposits of povidone in the tubular-interstitial area.
Croatian: Prikazani su rezultati 6 biopsija bubrega i svi dokazuju depozite povidona u tubularno-intersticijskom području.
English: For the other eight cases, renal biopsies were lacking, but povidone deposits were detected in biopsies from other tissues.
Croatian: Za ostalih osam slučajeva nisu provedene biopsije bubrega, ali su naslage povidona nađene u bioptatima drugih tkiva.
English: To lift the suspension, this product should be appropriately reformulated taking into account its misuse potential.
Croatian: Da bi se ukinula suspenzija ovaj lijek treba preformulirati na odgovarajući način uzimajući u obzir njegov potencijal za zloporabu.
English: In most cases, prescription or use of methadone can be confirmed, while some of them also have admitted injecting oral methadone.
Croatian: U većini slučajeva moguće je potvrditi propisivanje ili uporabu metadona dok su pojedini bolesnici također priznali i injektiranje peroralne otopine metadona;
English: In nine cases a history of drug abuse with substances that have been injected was specified and in eight of these nine cases a history of injecting methadone intended for oral use was reported.
Croatian: U devet slučajeva anamneza zloporabe lijeka putem injiciranja supstanci specifično je pojašnjena te u osam od devet tih slučajeva prijavljena anamneza injiciranja metadona koji je bio namijenjen za peroralnu primjenu.
English: Methadone is used in the treatment of moderate to severe pain and is also used as maintenance/substitution medication in the management of opioid dependence.
Croatian: Metadon se koristi u liječenju umjerene do teške boli te se također koristi kao lijek za održavanje/nadomještanje u liječenju ovisnosti o opijatima.
English: Following parenteral administration, it is generally accepted that low molecular weight povidone (Mw <25 000) is readily excreted by the kidney: the glomerulus can excrete within a few days all povidone of Mw 40 000 or below; the normal glomerulus of healthy human subjects is relatively impermeable to povidone Mw >70 000 (while in humans with nephrotic disease, the permeability for larger molecules was increased); the reticuloendothelial system (RES) retains molecules with a Mw >110,000 (Ravin et al. 1952; Hulme and Hardwicke 1968).
Croatian: Nakon parenteralne primjene općeprihvaćeno stajalište je da se povidon niske molekulske mase (Mm < 25 000) lako izlučuje bubrezima: glomerul može izlučiti unutar nekoliko dana sav povidon molekulske mase 40 000 ili manje; normalan glomerul zdravog ispitanika relativno je nepropustan na povidon molekulske mase > 70 000 (dok u ljudi s nefrotskom bolešću propusnost za veće molekule je povećana); retikuloendotelni sustav (RES) zadržava molekule s Mm > 110 000 (Ravin et al. 1952.; Hulme and Hardwicke 1968.).
English: The distribution and elimination of povidone when administered intravenously has been well investigated and studies using radioactive labelled povidone of different molecular weight have demonstrated that clearance of polymers after intravenous administration is dependent on molecular weight.
Croatian: Distribucija i eliminacija intravenski primijenjenog povidona dobro je ispitana, a ispitivanja koja su koristila radioaktivno označeni povidon različitih molekulskih masa dokazala su da klirens polimera nakon intravenske primjene ovisi o molekulskoj masi.
English: It is mainly used in oral solutions (K90) as a viscosity-increasing agent, or as a binding agent (e.g. K25, K30) in tablets.
Croatian: Uglavnom se koristi u oralnim otopinama (K90) kao agens koji povećava viskoznost ili kao vezni agens (primjerice, K25, K30) u tabletama.
English: It followed the decision of NOMA to suspend the only methadonecontaining oral solution that contains povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Croatian: Procjena je uslijedila nakon odluke NOMA-e o suspenziji odobrenja jedine oralne otopine koja sadrži metadon i povidon, a koja se nalazi na tržištu, na temelju izvješća o ozbiljnim nuspojavama kod bivših ili sadašnjih ovisnika o ovom lijeku u Norveškoj.
English: Flexible-dose methadone maintenance therapy is more clinically effective than no drug therapy in dependent opioid users.
Croatian: Terapija održavanjem fleksibilnom dozom metadona klinički je djelotvornija od drugih terapija kod ovisnika o opijatima.
English: On 2nd April 2014, the Norwegian Medicines Agency, NOMA, triggered a referral under Article 107i of Directive 2001/83/EC concerning methadone-containing medicines for oral use containing povidone asking the PRAC to review the benefit-risk balance of all oral methadone medicines containing polyvinylpyrrolidone (more commonly known as povidone or PVP) authorised in the EU and to make a recommendation to the Human Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) on any measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Croatian: Norveška agencija za lijekove, NOMA, pokrenula je arbitražu u skladu s člankom 107.i Direktive 2001/83/EZ u vezi lijekova koji sadrže metadon za peroralnu primjenu te povidon tražeći od PRAC-a da procijeni omjer koristi i rizika za sve peroralne lijekove koji sadrže metadon i polivinilpirolidon (poznatiji kao povidon ili PVP) odobrene u EU-u i da dadne preporuku Skupini za koordinaciju za međusobno priznavanje i decentralizirane postupke za humane lijekove (CMDh) o bilo kojim mjerama potrebnim za osiguravanje sigurne i djelotvorne uporabe te o tome je li odobrenje za stavljanje u promet potrebno održati, izmijeniti, suspendirati ili povući.
English: For five patients, bone destruction and/or bone marrow affection (including anaemia) were reported and findings from biopsies showed accumulation of povidone in the bone marrow.
Croatian: Za pet bolesnika prijavljeno je uništavanje kosti i/ili zahvaćenost koštane srži (uključujući anemiju), a nalazi biopsije pokazali su akumulaciju povidona u koštanoj srži.
English: The PRAC reviewed all available safety data, in particular with regards to the risks associated with the misuse by injection of methadone products for oral use containing povidone.
Croatian: PRAC je pregledao sve dostupne podatke o sigurnosti, posebice s obzirom na rizike povezane sa zloporabom injektiranjem peroralnog metadona koji sadrži povidon.
English: Although the brand of methadone cannot be confirmed with certainty it is suspected, based on the availability of the product and pattern of usage in Western Norway that the observed serious adverse reactions (e.g. anaemia and bone marrow disorder) were caused by povidone deposition in drug abusers who have misused methadone oral solutions containing povidone K90.
Croatian: Iako se marka metadona ne može potvrditi sa sigurnošću, sumnja se, na temelju raspoloživosti lijeka i uzorka uporabe u zapadnoj Norveškoj, da su uočene nuspojave (primjerice anemija i poremećaj koštane srži) uzrokovani naslagama povidona u osoba koje su zlorabile oralne otopine metadona koje sadrže povidon K90.
English: Pathological fractures were observed in two of the five patients, with deposits of povidone also in the bone tissue.
Croatian: Patološki prijelomi uočeni su kod dva od pet bolesnika također s naslagama povidona u koštanom tkivu.
English: • The PRAC reviewed all available data from published literature, pre-clinical and clinical studies and post-marketing experience on the safety of methadone medicinal products for oral use containing povidone, responses submitted by the marketing authorisation holders (MAHs) in writing and during the oral explanations, the outcome of the ad-hoc expert advisory group meeting as well as stakeholders' submissions in particular with regards to the risks associated with the misuse of the products by injection which is a well-known risk in the target population;
Croatian: • PRAC je pregledao sve dostupne podatke iz objavljene literature, nekliničkih i kliničkih ispitivanja i iskustava nakon stavljanja lijeka u promet o sigurnosti peroralnih lijekova koji sadrže metadon i povidon, odgovore koje su predali nositelji odobrenja za stavljanje u promet (MAH-ovi) napismeno i tijekom usmenih objašnjenja, ishod ad-hoc stručnog savjetodavnog sastanka, kao i podneske dionika posebice s obzirom na rizike povezane sa zloporabom lijekova putem injiciranja što je dobro poznat rizik u ciljnoj populaciji;
English: There is evidence that lower molecular weight povidone (<25,000) is readily excreted but that higher Mw povidone (>110,000) is not, or (>70,000) only partially excreted;
Croatian: Postoji dokaz da se povidon niže molekulske mase (< 25 000) brzo izlučuje, ali se povidon više molekulske mase (> 110 000) ne izlučuje ili se izlučuje samo djelomično (> 70 000).
English: • The PRAC was of the opinion that available pre-clinical and clinical data provide evidence that high molecular weight povidone (>110,000) when injected is likely to be permanently retained in the body, in particular in the bone marrow and bone tissue.
Croatian: • PRAC je smatrao da dostupni neklinički i klinički podatci pružaju dokaz da povidon visoke molekulske mase (> 110 000) prilikom iniciranja u tijelo iskazuje sklonost trajnom zadržavanju u tijelu, posebice u koštanoj srži i koštanom tkivu.
English: High Mw povidone (>110,000) will not be excreted by the kidney and therefore will be retained in the body if repeatedly injected and may lead to serious harm;
Croatian: Povidon velike molekulske mase (> 110 000) neće se izlučiti putem bubrega i stoga će se zadržati u tijelu ako se opetovano injicira te može uzrokovati ozbiljno oštećenje;
English: • The PRAC considered case reports, including fatal cases, in former or current injecting drug users, and noted the serious adverse reactions, the nature of which (including bone marrow adverse effects and pathological fractures) was consistent with the accumulation of povidone and also noted that povidone deposition in organs and tissues had been seen on biopsies.
Croatian: • PRAC je razmatrao slučajeve, uključujući i smrtonosne slučajeve, kod bivših ili sadašnjih intravenskih korisnika droga i zabilježio ozbiljne nuspojave čija je priroda (uključujući i nuspojave na kostima i patološke prijelome) bila dosljedna s akumulacijom povidona te je također zabilježio da su naslage povidona u organima i tkivima zabilježene u biopsijama.
English: • The PRAC noted that the risk of misuse by injection of methadone products for oral use is wellknown in the target population, evidence of which is available from the literature;
Croatian: • PRAC je zabilježio da je rizik od zloporabe lijekova koji sadrže metadon za peroralnu primjenu putem injiciranja dobro poznat u ciljnoj populaciji, a dokaz je dostupan u literaturi;
English: Methadone tablets containing low Mw povidone (K25 or K30)
Croatian: Tablete metadona koje sadrže povidon niske molekulske mase (K25 ili K30)
English: High molecular weight povidone therefore accumulates if injected intravenously and povidone deposition in organs and tissues (in particular bone marrow and bone tissue) have been reported in the literature after substantial intravenous administration leading to ‘povidone storage disease' (Kepes et al. 1993; Kuo et al. 1997; Dunn et al. 1998; Huang et al. 2012).
Croatian: Stoga se povidon velike molekulske mase akumulira ako se injicira intravenski, a naslage povidona u organima i tkivima (posebice u koštanoj srži i kostima) prijavljene su u literaturi nakon značajne intravenske primjene koja je uzrokovala „bolest taloženja povidona” (Kepes at al. 1993.; Kuo et al. 1997.; Dunn et al. 1998.; Huang et al.
English: Povidone is an excipient available in a variety of different molecular sizes from K12 (low molecular weight (Mw), average Mw ~ 2000) to K90 (high Mw, average Mw 1,100,000).
Croatian: Povidon je pomoćna tvar dostupna u različitim molekulskim veličinama od K12 (niska molekulska masa, prosječna molekulska masa ~ 2000) do K90 (visoka molekulska masa, prosječna molekulska masa 1 100 000).
English: Other methadone products containing povidone concerned by the review are tablets and have lower Mw povidone (e.g. K25, K30, also in lower amount), which is known to be excreted from the kidney and therefore is expected not to be retained in the body.
Croatian: Drugi metadonski lijekovi koji sadrže povidon, a zahvaćeni su procjenom su tablete te sadrže povidon niže molekulske mase (primjerice K25, K30 također u nižim količinama), a za koje se zna da će se izlučivati iz bubrega i stoga se očekuje da se neće zadržavati u tijelu.
English: Methadone oral solution containing high molecular weight povidone (K90)
Croatian: Oralne otopine metadona koje sadrže povidon visoke molekulske mase (K90)
English: The CMDh also reached an agreement on the variation to the terms of the Marketing Authorisations for methadone tablets containing low molecular weight povidone (K25 or K30) for which the amendments to be introduced to the Summary of Product Characteristics and package leaflet are set out in Annex III.
Croatian: CMDh je također postigao dogovor o izmjeni uvjeta odobrenja za stavljanje lijeka u promet za tablete metadona koje sadrže povidon niske molekulske mase (K25 ili K30) za koje su izmjene koje će se uvesti u Sažetak opisa svojstava lijeka i uputu o lijeku opisane u Dodatku III.
English: Therefore, the PRAC considered that additional risk minimisation measures 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: Stoga je PRAC smatrao da dodatne mjere minimizacije rizika 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: • The PRAC considered that the potential for harm was likely to be associated with the misuse of methadone oral solutions containing high molecular weight povidone K90;
Croatian: • PRAC je smatrao da je vjerojatno da je potencijal za oštećenje povezan sa zloporabom oralnih otopina metadona koje sadrže povidon visoke molekulske mase K90;