FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to posology, as some patients may experience loose stools or diarrhoea after the intake of two capsules per day during the first few weeks of treatment, it is advisable to start treatment with half the recommended daily dose, i.e. one capsule of diacerein 50 mg per day.
Croatian: S obzirom na doziranje te imajući u vidu da neki bolesnici mogu iskusiti mekanu stolicu ili proljev nakon unosa dvije kapsule po danu tijekom prvih nekoliko tjedana liječenja, preporučuje se započeti liječenje polovicom preporučene dnevne doze, tj. jednom kapsulom diacereina od 50 mg na dan.
English: The PRAC recommended not to use diacerein-containing medicinal product for patients older than 65 years, but did not consider it as a contraindication.
Croatian: PRAC je preporučio da se ne koriste lijekovi koji sadrže diacerein kod bolesnika starijih od 65 godina, ali ta dob nije smatrana kontraindikacijom.
English: In spontaneous reports, one quarter of serious gastrointestinal cases were related with diarrhoea.
Croatian: U spontanim izvješćima, jedna četvrtina ozbiljnih probavnih slučajeva bila je povezana s proljevom.
English: In addition treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected.
Croatian: Pored toga, liječenje diacereinom treba obustaviti ako se uoči povišenje jetrenih enzima ili se sumnja na znakove ili simptome oštećenja jetre.
English: It was noted that favourable results for the primary criterion, analogue visual scale (VAS) assessment of pain on movement, were shown in patients treated with 50mg/day.
Croatian: Zabilježeno je da su dokazani povoljni rezultati za primarni kriterij procjenom boli kod kretanja analognom vizualnom ljestvicom (VAS) kod bolesnika koji su liječeni dozom od 50 mg/dan.
English: In addition, warnings were considered necessary for patients receiving concomitantly diuretics, cardiac glycosides or laxatives.
Croatian: Pored toga, upozorenja su smatrana potrebnim za bolesnike koji su istovremeno primali diuretike, srčane glikozide ili laksative.
English: Pain and functional disability of the affected joints are the main manifestations of osteoarthritis.
Croatian: Bol i funkcionalna nesposobnost zahvaćenih zglobova glavne su manifestacije osteoartritisa.
English: Diacerein and its active metabolite, rhein, are anthranquinone derivates.
Croatian: Diacerein i njegov aktivni metabolit rein derivati su antrakinona.
English: In the second clinical trial, diacerein was included in one of the control groups in a trial intending to demonstrate the effect of hyaluronic acid intra-articular injections in OA progression which was not demonstrated.
Croatian: U drugom kliničkom ispitivanju diacerein je uključen u jednu kontrolnu skupinu u ispitivanju čiji je cilj bio dokazati učinak intraartikularnih injekcija hijaluronske kiseline na napredak OA koji nije dokazan.
English: Furthermore, as previously assessed, a paracetamol sparing effect (in eight trials) and a sparing effect on NSAIDs (in one trial) could be detected, but further research would be needed as proof of evidence.
Croatian: Nadalje, u skladu s prethodnom procjenom, mogao se uočiti učinak poštede paracetamola (u osam ispitivanja) te poštedni učinak NSAID-a (u jednom ispitivanju), ali potrebno je daljnje istraživanje kako bi se to dokazalo.
English: It was also noted that in the majority of cases diacerein-induced diarrhoea started soon after treatment initiation, and seemed to be reversible after cessation of treatment.
Croatian: Također je zabilježeno da je u većini slučajeva proljev potaknut diacereinom započeo odmah nakon početka liječenja te se čini da je bio reverzibilan nakon prekida liječenja.
English: The CMDh also agreed with the PRAC that the PSURs should be submitted on a yearly basis.
Croatian: CMDh se također složio s PRAC-om da PSUR-eve treba dostavljati na godišnjoj bazi.
English: To conclude, the review found that the most frequently reported reactions with diacerein were, as expected, gastrointestinal disorders, especially diarrhoeas, which were frequently severe and leading to complications such as dehydration and disturbances of fluid and electrolyte balance.
Croatian: Za zaključak, pregled je otkrio da su najčešće prijavljene reakcije s diacereinom bile, kako se to i očekivalo, probavni poremećaji, posebice proljevi koji su često bili teški i uzrokovali su komplikacije poput dehidracije i poremećaja ravnoteže tekućina i elektrolita.
English: Only the Dougados study showed efficacy on variables related to a beneficial impact of diacerein on structural progression or disease modifying properties in OA.
Croatian: Samo je Dougadosovo ispitivanje pokazalo djelotvornost na varijablama povezanim s korisnim utjecajem diacereina na strukturalni napredak ili na modificirajuća svojstva bolesti kod OA.
English: Diacerein, as other anthraquinone derivatives, has a hepatotoxic effect for which the mechanism of action is unknown.
Croatian: Diacerein kao i drugi derivati antrakinona ima hepatotoksični učinak čiji mehanizam djelovanja nije poznat.
English: However, although double blind was an intended methodological feature of the clinical trials performed with diacerein, it was considered doubtful that blinding was achieved in practice, considering the very apparent effects (urine coloration, diarrhoea) produced by diacerein.
Croatian: Međutim, iako je dvostruko slijepi dizajn određen kao metodološka značajka kliničkih ispitivanja provedenih s diacereinom, bilo je upitno je li maskiranje postignuto u praksi uzimajući u obzir vrlo očite učinke (promjena boje urina, proljev) koje uzrokuje diacerein.
English: Furthermore, the PRAC considered that periodic updated safety reports (PSURs) should be submitted on a yearly basis.
Croatian: Nadalje, PRAC je smatrao da periodička izvješća o neškodljivosti lijeka (PSUR) treba predavati na godišnjoj bazi.
English: A laxative effect was observed in up to 50% of the diacerein-treated patients in clinical studies.
Croatian: Laksativni učinak zabilježen je u do 50 % bolesnika liječenih diacereinom u kliničkim ispitivanjima.
English: A reduction in the use of NSAID was only shown in one study and therefore a sparing effect of diacerein on NSAIDs could not be confirmed.
Croatian: Redukcija u uporabi NSAID-a dokazana je samo u jednom ispitivanju i stoga se poštedni učinak diacereina na NSAID nije mogao potvrditi.
English: In view of the above, the ANSM requested the PRAC to give a recommendation on the balance of benefits and risks of diacerein containing medicinal products in the authorised indications and whether their marketing authorisations should be maintained, varied, suspended or withdrawn.
Croatian: U smislu prethodno navedenog, ANSM je zatražila od PRAC-a preporuku o uravnoteženju koristi i rizika lijekova koji sadrže diacerein u odobrenim indikacijama te mišljenje treba li njihovo odobrenje za stavljanje u promet održati, izmijeniti, suspendirati ili povući.
English: Also, diacerein is no longer recommended for patients aged 65 years and above.
Croatian: Diacerein se također više ne preporučuje za bolesnike u dobi od 65 godina.
English: This point was not addressed in any of the trials.
Croatian: Ovo pitanje nije razjašnjeno u kliničkim ispitivanjima.
English: The present review showed that rash, pruritus and eczema were the most common cutaneous reactions reported in clinical trials but available post-marketing data revealed cases of erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Croatian: Aktualni pregled pokazao je da su osip, pruritus i ekcem bili najčešće kutane reakcije prijavljene u kliničkim ispitivanjima ali dostupni podaci nakon stavljanja lijeka u promet otkrili su slučajeve multiformnog eritema, Stevens Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize (TEN).
English: In addition, and according to the clinical trials and bibliographical data, the efficacy appeared weak in the symptomatic treatment of osteoarthritis with low impact on pain and functional symptoms and with no demonstration of a decrease of NSAIDs intake in the population treated with diacerein.
Croatian: Pored toga, u skladu s kliničkim ispitivanjima i bibliografskim podacima, djelotvornost se čini slabijom kod simptomatskog liječenja osteoartritisa sa slabim utjecajem na bol i funkcionalne simptome i bez dokazivanja smanjenog unosa NSAID lijekova kod populacije liječene diacereinom.
English: To ensure adequate screening of the patients at start of treatment, the PRAC also recommended that diacerein is only initiated by specialists experienced in the treatment of osteoarthritis.
Croatian: Kako bi se osigurao odgovarajući probir bolesnika na početku liječenja, PRAC je također preporučio da se liječenje diacereinom započne samo od strane specijalista iskusnih u liječenju osteoartritisa.
English: Diacerein was mainly indicated as an oral treatment for osteoarthritis (OA), a chronic joint degenerative disease with a high prevalence in the ageing population.
Croatian: Diacerein je uglavnom indiciran kao oralna terapija osteoartritisa (OA), kronične degenerativne bolesti zglobova s visokom prevalencijom u populaciji koja stari.
English: The main studies evaluating structural progression or disease modifying properties in OA ((i) Echodiah study (Dougados et al. 2001) with 255 patients in the diacerein arm and 252 under placebo for three years of treatment; and (ii) Pham study (2004) which included 85 patients in the diacerein arm and 85 under placebo during one year) did not show convincing evidence of efficacy of diacerein on pain or physical functioning.
Croatian: 2001.) s 255 bolesnika koji su primali diacerein i 252 bolesnika u skupini koja je primala placebo tijekom tri godine liječenja; i (ii) Pham ispitivanje (2004.) koje je uključivalo 85 bolesnika u skupini koja je primala diacerein i 85 bolesnika koji su primali placebo tijekom godine dana) nisu pokazali uvjerljiv dokaz djelotvornosti diacereina na bol ili fizikalno funkcioniranje.
English: Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Croatian: Bolesnike treba savjetovati da ograniče unos alkohola dok se liječe diacereinom.
English: In 2012, the French national competent authority (Agence nationale de sécurité du médicament et des produits de santé, ANSM) initiated a review of the benefit-risk of diacerein containing medicinal products that underlined the occurrence of very frequent digestive disorders, cases of hepatitis and serious skin reactions in patients treated with diacerein.
Croatian: U 2012. godini francuske državne vlasti (Agence nationale de sécurité du médicament et des produits de santé, ANSM) započele su s pregledom omjera koristi i rizika za lijekove koji sadrže diacerein što je naglasilo pojavu visoke učestalosti probavnih poremećaja, slučajeve hepatitisa i ozbiljnih kožnih reakcija u bolesnika liječenih diacereinom.
English: With regards to the potential risk of hepatic reactions, several hepatic events have been reported, including serious hepatic reactions and one fatal case of hepatitis was reported.
Croatian: S obzirom na potencijalni rizik od jetrenih reakcija, prijavljeno je nekoliko jetrenih događaja uključujući ozbiljne jetrene reakcije i jedan smrtonosni slučaj hepatitisa.
English: As part of this referral procedure, the PRAC reviewed all available data on the efficacy of diacerein containing medicinal products.
Croatian: Kao dio postupka arbitraže, PRAC je pregledao sve dostupne podatke o djelotvornosti lijekova koji sadrže diacerein.
English: Finally, information on the cutaneous risk in the Summary of Product Characteristics (SmPC) was considered necessary.
Croatian: Naposljetku, smatra se da je potrebno uključiti informacije o kutanim rizicima u Sažetak opisa svojstava lijeka (SmPC).
English: The PRAC considered that it is of importance that patients stop their treatment with diacerein as soon as diarrhoea occurs, in order to prevent diarrhoea complications such as dehydration and hypokalaemia.
Croatian: PRAC je smatrao da je važno da bolesnici prekinu liječenje diacereinom čim se pojavi proljev kako bi se spriječile komplikacije poput dehidracije i hipokalijemije.
English: It was also concluded that diacerein should no longer be recommended in patients aged 65 years and above as this patient population is more vulnerable to diarrhoea complications.
Croatian: Zaključeno je da se diacerein više ne bi smio preporučivati kod bolesnika u dobi od 65 godina i više jer je ta populacija bolesnika osjetljivija na komplikacije proljeva.
English: The available data were therefore not sufficient to conclude on the structure modifying effects of diacerein in osteoarthritis and no data were available regarding a potential effect of diacerein for delaying surgery.
Croatian: Dostupni podaci stoga nisu bili dostatni za donošenje zaključka u pogledu modificirajućih učinaka diacereina na strukturu kod osteoartritisa i nije bilo dostupnih podataka u vezi potencijalnog učinka diacereina na odgodu kirurškog zahvata.
English: Although it was noted that the data from clinical studies showed no significant differences in hepatic disorders between diacerein and the placebo group, when present, hepatic disorders were in most of cases in the diacerein group.
Croatian: Iako je zabilježeno da podaci iz kliničkih ispitivanja nisu pokazali značajne razlike u jetrenim poremećajima između skupine koja je primala diacerein i placebo, jetreni su poremećaji kad bi se javljali uglavnom bili prisutni u skupini s diacereinom.
English: Finally, several double-blind randomised clinical trials analysed the alleged NSAID sparing effect of diacerein as a secondary endpoint.
Croatian: Naposljetku, nekoliko dvostruko slijepih, randomiziranih kliničkih ispitivanja analiziralo je navodni poštedni učinak NSAID-a na diacerein kao sekundarnu krajnju točku.
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diacerein containing medicinal products for which the amendments to the product information are set out in annex III and subject to the condition set out in Annex IV.
Croatian: CMDh je razmotrivši revidirane konačne preporuke PRAC-a od 10. srpnja 2014. godine u skladu s člankom 107.k stavcima 1. i 2. Direktive 2001/83/EZ izrazio stajalište o izmjeni odobrenja za stavljanje lijekova u promet koji sadrže diacerein za koje su nadopune informacija o lijeku opisane u Dodatku III. te su podložne uvjetima opisanim u Dodatku IV.
English: The evidence obtained from different meta-analysis of the clinical trials performed with diacerein showed a small beneficial effect of diacerein in the treatment of OA of the knee and hip with different criteria for the inclusion of the clinical trials in the meta-analyses.
Croatian: Dokaz dobiven iz različitih meta analiza kliničkih ispitivanja provedenih s diacereinom pokazali su mali korisni učinak diacereina u liječenju osteoartritisa koljena i kuka s različitim kriterijima za uključivanje kliničkog ispitivanja u meta analize.
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 with regards to diacerein containing medicinal products, agrees with the recommendation therein as stated below:
Croatian: CMDh nakon što je razmotrio revidiranu konačnu preporuku PRAC-a od 10. srpnja 2014. godine s obzirom na lijekove koji sadrže diacerein, slaže se s preporukama iznesenim u nastavku:
English: The product information should reflect the recommendation to monitor signs of hepatic injury and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury.
Croatian: Informacije o lijeku moraju sadržavati preporuku za nadzor znakova ozljede jetre i oprez koji je potreban kad se diacerein koristi istovremeno s drugim lijekovima koje se povezuje s ozljedama jetre.
English: It was reiterated that structure-modifying effects of cartilage by diacerein in OA and long-term efficacy had not been demonstrated by the presented studies; however, a carry-over effect was confirmed by three studies.
Croatian: Ponovljeno je da učinci diacereina koji modificiraju strukturu hrskavice u osteoartritisu i dugoročna djelotvornost nisu dokazane trenutnim ispitivanjima; međutim, učinak prijenosa potvrđen je u tri ispitivanja.
English: Notwithstanding this, and given the new proposals from the MAHs on possible measures to minimise the risks, the PRAC carried out a new assessment of the available data in the context of the re-examination.
Croatian: Ne uzimajući u obzir sve navedeno i s obzirom na nove prijedloge nositelja odobrenja o mogućim mjerama minimizacije rizika, PRAC je proveo nove procjene o dostupnim podacima u smislu ponovnog pregleda.
English: Some studies revealed that 25% patients with diarrhoea during diacerein treatment experienced chronic diarrhoeas, defined by diarrhoea persisting more than 4 weeks.
Croatian: Neka su ispitivanja otkrila da je 25% bolesnika s proljevom tijekom liječenja diacereinom iskusilo kronične proljeve koji su potrajali dulje od 4 tjedna.
English: • The PRAC considered that the available data supporting the use of diacerein have shown a modest but statistically significant effect in the treatment of osteoarthritis of the knee and hip, with a delayed effect.
Croatian: • PRAC je smatrao da su dostupni podaci koji podupiru uporabu diacereina pokazali skromni, ali statistički značajan učinak na liječenje osteoartritisa koljena i kuka s odgođenim učinkom.
English: These included reducing the posology recommendation at the start of the treatment, and new measures such as a contraindication in patients with liver disease, a strong recommendation for patients to stop treatment as soon as diarrhoea occurs and a restriction of use in patients aged 65 years and above.
Croatian: Te su uključivale preporuke o doziranju na početku liječenja i nove mjere poput kontraindikacija kod bolesnika s bolesti jetre i snažnu preporuku za bolesnike koji su prekinuli liječenje čim se pojavio proljev te ograničenje uporabe u bolesnika u dobi od 65 i više godina.
English: In addition, meta-analyses confirmed a small but consistent beneficial effect of diacerein on OA symptoms.
Croatian: Pored toga, meta analize potvrdile su mali, ali dosljedni korisni učinak diacereina na simptome osteoartritisa.
English: Therefore, diacerein is still a relevant option for some patients for symptomatic treatment of OA of the hip and knee, but caution is advised and patients must stop treatment should diarrhoea develop.
Croatian: Stoga, diacerein je još uvijek važna opcija za neke bolesnike u simptomatskom liječenju OA koljena i kuka, ali se savjetuje oprez i upućuje na činjenicu da se s liječenjem mora prekinuti ako se pojavi proljev.
English: Diacerein has a delayed initial onset of action and should not be recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Croatian: Diacerein ima odgođeni nastup djelovanja i ne smije ga se preporučivati kod bolesnika s rapidno ubrzanim progresivnim osteoartritisom kuka jer mogu imati slabiji odgovor na diacerein.
English: Based on the totality of the data available on the safety and the efficacy of diacerein, and considering all the risk minimisation measures proposed during assessment and the re-examination procedure, the PRAC concluded that the benefit-risk balance of diacerein-containing medicinal products remained favourable in the symptomatic treatment osteoarthritis, subject to changes to the product information and conditions.
Croatian: Na temelju ukupnih dostupnih podataka o sigurnosti i djelotvornosti diacereina te uzimajući u obzir sve mjere minimizacije rizika koje su predložene tijekom procjene i postupka ponovnog pregleda podataka, PRAC je zaključio da je omjer koristi i rizika lijekova koji sadrže diacerein u simptomatskom liječenju osteoartritisa podložan promjenama u informacijama o lijeku i uvjetima izdavanja lijeka.
English: With regards to the risk of gastrointestinal disorders, diarrhoea was a common and expected reaction of diacerein.
Croatian: S obzirom na rizik od probavnih poremećaja, proljev je bio česta i očekivana reakcija diacereina.
English: Finally, with regards to the risk of cutaneous disorders, safety concerns were raised with diacerein following a publication of a fatal case of a toxic epidermal necrolysis, with diacerein being the most suspected drug for the events.
Croatian: Konačno, s obzirom na rizik od kutanih poremećaja, pojavile su se sigurnosne bojazni kod uzimanja diacereina nakon objavljivanja smrtonosnog slučaja toksične epidermalne nekrolize kod koje je diacerein bio najsuspektniji lijek.
English: With regards to the safety profile of diacerein, it was noted that the most frequently reported events with diacerein when used as per label (100mg/day) in the clinical trials, were loose stools and diarrhoea, including severe diarrhoea.
Croatian: S obzirom na sigurnosni profil diacerein, zabilježeno je da su najčešće prijavljivani događaji s diacereinom kad se primjenjivao u skladu s označivanjem (100 mg/dan) u kliničkim ispitivanjima bili mekana stolica i proljev uključujući i teški proljev.
English: The PRAC also noted that spontaneous notifications reported serious cases of diarrhoea with dehydration and electrolyte disorders.
Croatian: PRAC je zabilježio da spontane obavijesti sadrže prijavljene ozbiljne slučajeve proljeva s dehidracijom i poremećajima elektrolita.
English: Diacerein is a symptomatic slow acting drug in osteoarthritis (SYSADOA).
Croatian: Diacerein je simptomatski lijek sporog djelovanja za liječenje osteoartritisa (SYSADOA).
English: The PRAC acknowledged that although neither the available randomised clinical trials nor the metaanalyses were without flaws, clinical trials show a modest and statistically significant effect for diacerein in the end-points pain relief and function disability.
Croatian: PRAC je potvrdio da iako niti dostupni podaci iz randomiziranih kliničkih ispitivanja niti iz meta analiza nisu savršeni, klinička ispitivanja pokazuju umjereni i statistički značajan učinak diacereina u krajnjim točkama olakšavanja boli i funkcionalne onesposobljenosti.
English: These included a recommendation to start treatment at half the normal daily dose, a contraindication in patients with a history and/or current liver disease and a clear recommendation for patients to stop treatment as soon as diarrhoea occurs.
Croatian: To uključuje preporuke o početku liječenja s polovicom uobičajene doze, kontraindikaciju za bolesnike s anamnezom i/ili trenutnom bolesti jetre i jasnu preporuku za bolesnika o prekidu liječenja čim se pojavi proljev.
English: The high dropout rate due to diarrhoea in clinical trials showed that the acceptability of the treatment was worse in the diacerein group than in the placebo group.
Croatian: Visoki postotak izostanaka u kliničkim ispitivanjima zbog proljeva pokazao je da je prihvatljivost liječenja bila gora u skupini koja je primala diacerein nego u skupini koja je primala placebo.
English: The structure-modifying effects of diacerein have also been assessed in few studies as well as its NSAIDs sparing effect (secondary endpoint).
Croatian: Učinci promjene strukture lijeka diacerein također su procijenjeni u nekoliko ispitivanja kao i u nekoliko poštednih učinaka NSAID lijekova (sekundarna krajnja točka).
English: • The PRAC considered the grounds for re-examination provided by the MAHs in writing and in the oral explanations;
Croatian: • PRAC je razmatrao temelje za ponovnu procjenu koje je osigurao nositelj odobrenja napismeno i usmeno;
English: In addition, given the gastrointestinal risk and potential risk of hepatic reactions, the PRAC considered necessary to restrict prescription to specialists experienced in the treatment of osteoarthritis.
Croatian: Osim toga, s obzirom na rizik od probavnih poremećaja i potencijalni rizik od jetrenih reakcija, PRAC je smatrao potrebnim ograničiti propisivanje na liječnike iskusne u liječenju osteoartritisa.