FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally the CHMP noted that the current international consensus for the recognition of ‘sufficient evidence in humans of the carcinogenicity' of arsenic trioxide along with the strict limitation of arsenic trioxide in the drinking water does no longer support the use of arsenic trioxide within the therapeutic armamentarium.
Croatian: Naposljetku je CHMP primijetio kako trenutno postoji međunarodni konsenzus o potvrđenim „dostatnim dokazima za kancerogenost u ljudi” arsenova trioksida kao i strogim ograničenjima arsenova trioksida u vodi za piće, te se više ne podržava uporaba arsenova trioksida kao terapijskog sredstva.
English: The Committee considered that the potential for genotoxic, carcinogenic and reprotoxic effects of the systemic exposure to arsenic trioxide combined with the lack of knowledge about the extent of systemic exposure from the dental use of the arsenic trioxide paste is not acceptable.
Croatian: Povjerenstvo je zaključilo da potencijal za genotoksične, kancerogene i reprotoksične učinke sistemskog izlaganja arsenovom trioksidu u kombinaciji s nedostatkom spoznaja o stupnju sistemskog izlaganja iz dentalne uporabe paste arsenova trioksida nije prihvatljiv.
English: In its assessment the CHMP considered all available data submitted by the MAHs as well as published literature and data available to the Member States.
Croatian: U svojoj procjeni CHMP je uzeo u obzir sve dostupne podatke koje su predali nositelji odobrenja kao i objavljenu literaturu i podatke dostupne državama članicama.
English: A detailed analysis of the risks of clastogenicity or/and aneugenicity as those are recognised as a risk factor for cancer when impacting somatic cells, and teratogenicity, embryo-toxicity/spontaneous abortions and impaired male fertility, when impacting germinal cells.
Croatian: Slijedi detaljna analiza rizika klastogenosti ili/i aneugeničnog djelovanja budući da su oni prepoznati kao čimbenici rizika za karcinom prilikom utjecaja na somatske stanice te teratogenost, embriotoksičnost/spontane pobačaje i oštećenu plodnost kod muškaraca prilikom utjecaja na germinalne stanice.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use (see Annex I).
Croatian: • CHMP je razmotrio postupak u skladu s člankom 31. Direktive 2001/83/EZ za lijekove Caustinerf arsenical, Yranicid arsenical i druge pridružene nazive lijekova za topikalnu primjenu (vidjeti Prilog I.).
English: Also, since no reproductive toxicity studies in animals were conducted with Caustinerf arsenical or Yranicid arsenical, the MAHs provided a brief review of available data in scientific literature regarding effects of inorganic arsenic on reproduction.
Croatian: Također, s obzirom da nisu provedena ispitivanja reproduktivne toksičnosti na životinjama prilikom primjene lijekova Caustinerf arsenical ili Yranicid arsenical, nositelji odobrenja podnijeli su kratak pregled dostupnih podataka iz znanstvene literature u vezi s učincima anorganskog arsena na reprodukciju.
English: The CHMP took in account the MAH's position.
Croatian: CHMP je uzeo u obzir stajalište nositelja odobrenja.
English: The MAHs did not recently conduct any clinical trial with arsenic trioxide in dental paste.
Croatian: Nositelji odobrenja nisu nedavno provodili nikakva klinička ispitivanja s arsenovim trioksidom u zubnoj pasti.
English: In addition, following a review of the whole marketing authorisation supportive dossier a new information was highlighted by the MAH with regards to the systemic passage of arsenic that cannot be excluded.
Croatian: Pored toga, nakon pregleda ukupnog popratnog dosjea uz odobrenje za stavljanje lijeka u promet, nositelj odobrenja naglasio je nove informacije s obzirom na prolazak arsena kroz sistemski krvotok što se ne može isključiti.
English: In parallel, new genotoxicity assays (Ames test and in vitro micronuleus test) were conducted by the MAH with dental paste extracts of Caustinerf arsenical and the results were positive in the in vitro micronuleus test only.
Croatian: Usporedno s time, nova ispitivanja genotoksičnosti (Amesov test i in vitro testiranje mikronukleusa) koje je proveo nositelj odobrenja s ekstraktima zubne paste Caustinerf arsenical i rezultati su bili pozitivni samo za in vitro testiranje mikronukleusa.
English: The review of the available efficacy data (including data which became available since the initial marketing authorisation), showed limited efficacy of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in its approved indication which does not translate in evidence of a benefit for patients in particular in the current context of the therapeutic strategy where the knowledge acquired in pulp's devitalisation and analgesia techniques has considerably improved, and where safer options are available.
Croatian: Pregled dostupnih podataka o djelotvornosti (uključujući podatke koji su postali dostupni nakon dobivanja početnog odobrenja za stavljanje lijeka u promet) pokazuje ograničenu djelotvornost lijekova Caustinerf arsenical, Yranicid arsenical i drugih pridruženih naziva lijekova za topikalnu primjenu u njihovim odobrenim indikacijama koja se ne može protumačiti kao dokaz koristi za bolesnike, posebice u aktualnom kontekstu terapijske strategije gdje su se spoznaje stečene o devitalizaciji pulpe i tehnikama analgezije znatno poboljšale i gdje su dostupne sigurnije mogućnosti.
English: The risk of genotoxicity including human fertility, foetal development and carcinogenicity induced by arsenic trioxide was reviewed.
Croatian: Pregledan je rizik od genotoksičnosti uključujući i plodnost kod ljudi, fetalni razvoj i kancerogenost koju inducira arsenov trioksid.
English: The CHMP acknowledges that:
Croatian: CHMP potvrđuje da:
English: • has an impact on germinal cells and is reprotoxic in animals and humans, The CHMP is of the view that the overall risk of cancer, early foetal loss and impact on fertility associated with the use of Caustinerf arsenical, Yranicid arsenical and other medicinal products cannot be ruled out and the risk minimisation measures proposed by the MAHs will not allow avoiding the impact on human fertility.
Croatian: • ima utjecaj na germinalne stanice te je reprotoksičan u životinja i ljudi, CHMP smatra da se ukupan rizik od karcinoma, ranog gubitka ploda i utjecaja na plodnost koji su povezani s uporabom lijekova Caustinerf arsenical, Yranicid arsenical i drugih lijekova ne može isključiti i da mjere za smanjivanje rizika koje su predložili nositelji odobrenja neće omogućiti izbjegavanje utjecaja na plodnost kod ljudi.
English: Risk minimisation measures proposed by the MAH such as amendments to the product information (restriction for use, addition of contraindications in paediatric population and during pregnancy and lactation), communication material and a PASS were considered during the discussions.
Croatian: Tijekom rasprave razmatrane su mjere za smanjivanje rizika koje je predložio nositelj odobrenja poput izmjena informacija o lijeku (ograničenje uporabe, dodavanje kontraindikacija za pedijatrijsku populaciju te uporabu tijekom trudnoće i dojenja), materijali za komunikaciju i sigurnosna ispitivanja nakon stavljanja lijeka u promet (PASS).
English: After considering the data available and the risk minimisation measures proposed by the MAHs, the CHMP is of the view that the risk of osteonecrosis, soft tissue and dental necrosis, bone fistula and gingival discoloration is highly difficult to minimise or avoid.
Croatian: Nakon razmatranja dostupnih podataka i mjera za smanjivanje rizika koje su predložili nositelji odobrenja, CHMP smatra da je rizik od osteonekroze, nekroze mekog tkiva i dentalne nekroze, fistule na kostima i promjene boje gingive vrlo teško umanjiti ili izbjeći.
English: The CHMP is of the view that these risk minimisation measures would not be able to adequately reduce the risks associated to those products..
Croatian: CHMP je došao do zaključka da te mjere za smanjivanje rizika neće moći na odgovarajući način smanjiti rizike povezane s tim lijekovima.
English: The French NCA therefore referred the matter to the CHMP to give an opinion under Article 31 of Directive 2001/83/EC on whether the MAs of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use products should be maintained, varied, suspended or revoked.
Croatian: Francusko nacionalno nadležno tijelo uputilo je predmet CHMP-u kako bi se dobilo njihovo mišljenje u skladu s člankom 31. Direktive 2001/83/EZ o tome treba li odobrenja za stavljanje u promet lijekova Caustinerf arsenical, Yranicid arsenical i drugih pridruženih naziva lijekova za topikalnu primjenu zadržati, izmijeniti, privremeno oduzeti ili oduzeti.
English: The expert panel concluded that the benefit/risk of the product was negative.
Croatian: Panel stručnjaka zaključio je da je omjer koristi i rizika lijeka negativan.
English: • many cases of osteonecrosis, soft tissue and dental necrosis, bone fistula and gingival discoloration have been reported, which is considered as serious adverse effect, management of which is very complicated.
Croatian: • su prijavljeni mnogi slučajevi osteonekroze, nekroze mekog i zubnog tkiva, fistula na kostima i promjena boje gingive što se smatra ozbiljnim nuspojavama čije je liječenje vrlo složeno,
English: • The CHMP considered that the additional risk minimisation measures proposed by the Marketing Authorisation Holders would not be able to adequately reduce the risk of carcinogenicity and serious adverse reactions to a clinically acceptable level.
Croatian: • CHMP smatra da dodatne mjere za smanjivanje rizika koje su predložili nositelji odobrenja neće moći smanjiti rizik od kancerogenosti na odgovarajući način te incidenciju ozbiljnih nuspojava na klinički prihvatljivu razinu.
English: Having considered all available data from pre-clinical, clinical studies, published literature and postmarketing experience on Caustinerf arsenical, Yranicid arsenical and other associated names for topical use containing products provided by the MAHs in writing and during an Oral Explanation, the Committee considered that the use of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use is associated with risks of carcinogenicity and serious necrosis adverse reactions sometimes with sequelae.
Croatian: Imajući u vidu sve podatke dostupne iz nekliničkih i kliničkih ispitivanja, objavljenje literature i iskustva nakon stavljanja u promet lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu koje je nositelj odobrenja podnio pismeno i tijekom usmenog objašnjenja, Povjerenstvo je došlo do zaključka da je uporaba lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu povezana s rizicima od kancerogenosti i ozbiljnih nuspojava nekroze, ponekad i s posljedicama.
English: • The CHMP considered the genotoxicity of arsenic trioxide and that its use is associated with a potential risk of carcinogenicity and serious adverse reactions such as tissue necrosis sometimes leading to sequelae.
Croatian: • CHMP je razmotrio genotoksičnost arsenova trioksida i smatra da je njegova uporaba povezana s mogućim rizikom od kancerogenosti i ozbiljnim nuspojavama poput nekroze tkiva koja ponekad ima i posljedice.
English: On 24 October 2013, the CHMP started a referral procedure for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use.
Croatian: Dana 24. listopada 2013. CHMP je započeo postupak arbitraže za Caustinerf arsenical, Yranicid arsenical i druge pridružene nazive za topikalnu primjenu.
English: The MAHs conducted in vitro testing to assess the genotoxicity of the product Caustinerf arsenical and provided the results of an extensive review performed by an expert in toxicology on the impact of arsenic compounds on somatic cells.
Croatian: Nositelji odobrenja proveli su in vitro testiranje kako bi procijenili genotoksičnost lijeka Caustinerf arsenical i dostavili rezultate opsežne procjene koju je proveo stručnjak za toksikologiju o utjecaju arsenovih spojeva na somatske stanice.
English: • point out in the relevant SmPC section that the risk of carcinogenicity cannot be excluded and that there is a risk of necrosis of periodontal tissues.
Croatian: • se u određenom dijelu sažetka opisa svojstava lijeka (SmPC) istakne da se rizik od kancerogenosti ne može isključiti i da postoji rizik od nekroze perodontalnih tkiva.
English: The MAHs provided an extensive review of all available data from pre-clinical, clinical studies and postmarketing experience.
Croatian: Nositelji odobrenja osigurali su iscrpan pregled svih dostupnih podataka iz nekliničkih i kliničkih ispitivanja te iskustva nakon stavljanja lijeka u promet.
English: The CHMP considered the proposed changes by the MAHs in the Summary of Product Characteristics and Patient Leaflet to mitigate these risks and concluded that these risk minimisation measures would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level.
Croatian: CHMP je razmotrio izmjene SmPC-a i Upute o lijeku koje su predložili nositelji odobrenja radi smanjivanja tih rizika te zaključio da te mjere za smanjivanje rizika neće moći na odgovarajući način umanjiti rizike od ozbiljnih nuspojava na klinički prihvatljivu razinu.
English: The CHMP considered that Caustinerf arsenical, Yranicid arsenical and other associated names for topical use products are associated with potential risks of carcinogenicity, tissue necrosis and show a limited efficacy in their approved indication.
Croatian: CHMP smatra da su lijekovi Caustinerf arsenical, Yranicid arsenical i pridruženi nazivi lijekova za topikalnu primjenu povezani s potencijalnim rizicima od kancerogenosti, nekroze tkiva i da pokazuju ograničenu učinkovitost u svojoj odobrenoj indikaciji.
English: • The CHMP considered the totality of the data available for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in relation to its genotoxicity and the risk of carcinogenicity.
Croatian: • CHMP je razmotrio ukupne dostupne podatke za lijekove Caustinerf arsenical, Yranicid arsenical i pridružene nazive lijekova za topikalnu primjenu u vezi s njihovom genotoksičnosti i rizikom od kancerogenosti.
English: The provided study demonstrated low but measurable systemic level of arsenic after dental use.
Croatian: Dostavljeni rezultati ispitivanja pokazali su niske mjerljive razine arsena u sistemskom krvotoku nakon dentalne primjene.
English: Caustinerf arsenical, Yranicid arsenical and other associated names for topical use are indicated in the painless topical devitalisation of the dental pulp.
Croatian: Caustinerf arsenical, Yranicid arsenical i drugi pridruženi nazivi lijekova za topikalnu primjenu indicirani su za bezbolnu devitalizaciju zubne pulpe.
English: • The CHMP therefore concluded, in view of the available data, that the genotoxicity, the risk of carcinogenicity and tissue necrosis associated with the use of Caustinerf arsenical, Yranicid arsenical and associated names for topical use in the treatment of painless topical devitalisation of the dental pulp outweigh the limited benefits.
Croatian: • CHMP je stoga zaključio da, s obzirom na dostupne podatke, genotoksičnost, rizik od kancerogenosti i nekroze tkiva povezan s uporabom lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu u postupku bezbolne, topikalne devitalizacije pulpe zuba nadmašuje ograničene koristi.
English: • The CHMP considered that the available efficacy data, including data which became available since the initial marketing authorisations of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in its approved indication, were limited.
Croatian: • CHMP je došao do zaključka da su dostupni podaci o djelotvornosti, uključujući i podatke koji su postali dostupni nakon početnih odobrenja za stavljanje u promet, lijekova Caustinerf arsenical, Yranicid arsenical i drugih pridruženih naziva lijekova za topikalnu primjenu u njihovoj odobrenoj indikaciji ograničeni.
English: • A drug utilisation study (DUS) in order to verify the comprehension of the indication, the awareness of the safety concern, the minimisation measures in the SmPC in term of restriction of indication, the new caution related use of the product at different time (e.g. when the restricted indication is implemented/ 6 months after the implementation/ 18 months after the implementation).
Croatian: • ispitivanje potrošnje lijeka (DUS) kako bi se potvrdilo razumijevanje indikacije, svijest o dvojbama u pogledu sigurnosti, mjere za smanjivanje rizika navedene u SmPC-u u smislu ograničenja indikacije, nove uporabe lijeka povezane s mjerama opreza u različito vrijeme
English: The MAHs confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical benefit of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use containing products in local anaesthesia.
Croatian: Nositelji odobrenja potvrdili su da su dostavljeni svi dostupni podaci i da nisu u mogućnosti dostaviti nikakve dodatne podatke koji bi dokazali kliničku korist lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu u lokalnoj anesteziji.
English: The MAHs therefore applied for an USR to National Competent Authorities where the products are authorised, proposing to:
Croatian: Nositelji odobrenja stoga su se podnijeli su zahtjev za hitnim sigurnosnim ograničenjima (urgent safety restrictions - URS) nacionalnim nadležnim tijelima koja su lijekove odobrila s prijedlogom da:
English: Overall summary of the scientific evaluation of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use (see Annex I)
Croatian: Opći sažetak znanstvene procjene lijekova Caustinerf arsenical, Yranicid arsenical i drugih pridruženih naziva lijekova za topikalnu primjenu (vidjeti Prilog I.)
English: The CHMP therefore concluded that the benefit-risk balance of arsenic trioxide containing medicinal products is not favourable.
Croatian: CHMP je stoga zaključio da omjer koristi i rizika lijekova koji sadrže arsenov trioksid nije povoljan.
English: • The CHMP took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of Caustinerf arsenical, Yranicid arsenical and associated names for topical use in the painless topical devitalisation of the dental pulp.
Croatian: • CHMP je uzeo u obzir stajalište nositelja odobrenja da su dostavljeni svi dostupni podaci i da neće biti moguće dostaviti dodatne podatke za dokazivanje kliničke koristi lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu kod bezbolne devitalizacije pulpe zuba.
English: Grounds for revocation of the marketing authorisations of Caustinerf arsenical, Yranicid arsenical and associated names for topical use
Croatian: Temelji za oduzimanje odobrenja za stavljanje u promet lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu
English: o to contra-indicate the use of the products in children, pregnant and lactating women; o to reinforce the revised indication and local conditions, the sealing of the treated cavity in order to minimise direct leakage of the material and diffusion of the arsenic, the reduction of the exposure (3 days instead of 7 days) with close monitoring and warning of the occurrence of pain;
Croatian: • izmjene informacija o lijeku u dijelovima 4.1., 4.2., 4.3., 4.4., 4.5., 4.6., 4.8. i 5.3. SmPC-a: o ograničavanje indikacija na uporabu kao liječenje posljednjeg izbora, tj. u situacijama gdje nisu dostupne anestezijske tehnike ili ih nije moguće koristiti na bolesnicima iz EUa; o kontraindicirati uporabu lijekova u djece, trudnica i dojilja; o potkrijepiti revidirane indikacije i lokalne uvjete, plombiranje liječenog karijesa kako bi se smanjilo izravno propuštanje materijala i difuziju arsena, smanjenje izloženosti (3 dana umjesto 7 dana) uz pomni nadzor i upozorenje o pojavi bola;
English: Zizine) which revealed a potential of genotoxicity related to the use of arsenic trioxide.
Croatian: Pregledom literature koji su proveli nositelji odobrenja za stavljanje lijekova u promet (Septodont i A.T.O. Zizine) otkrivena je potencijalna genotoksičnost povezana s uporabom arsenova trioksida.
English: The CHMP therefore concluded that the benefit-risk balance of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in the indication of “painless topical devitalisation of the dental pulp” is not favourable.
Croatian: CHMP je stoga zaključio da omjer koristi i rizika lijekova Caustinerf arsenical, Yranicid arsenical i pridruženih naziva lijekova za topikalnu primjenu u indikaciji „bezbolna topikalna devitalizacija zubne pulpe” nije povoljan.
English: The CHMP, as a consequence, concluded that the risk-benefit balance for Caustinerf arsenical, Yranicid arsenical and associated names for topical use is not favourable.
Croatian: CHMP je stoga zaključio da omjer rizika i koristi za lijekove Caustinerf arsenical, Yranicid arsenical i pridružene nazive lijekova za topikalnu primjenu nije povoljan.
English: 3) have not been investigated.
Croatian: 3) nisu ispitane.
English: Your doctor will explain more.
Croatian: Liječnik će Vam reći više o tome.
English: Talk to a doctor if you do not feel better, or if you feel worse after 6 days.
Croatian: Obratite se liječniku ako se ne osjećate bolje, ili ako se osjećate lošije nakon 6 dana.
English: The clinical relevance of this finding is unknown.
Croatian: Klinički značaj ovog nalaza nije poznat.
English: It is especially important that you tell your doctor if you are also taking:
Croatian: Naročito je važno da obavijestite svog liječnika ako uzimate i:
English: Other side effects may include:
Croatian: Druge nuspojave mogu uključivati:
English: This medicine should not be used in children and adolescents as it has not been studied enough in these populations.
Croatian: Ovaj lijek ne smije se primjenjivati u djece i adolescenata jer nije dovoljno ispitan u tim populacijama.
English: Minimum Inhibitory Concentrations (mg/L)
Croatian: Minimalne inhibicijske koncentracije (mg/l)
English: Do not shake the bag.
Croatian: Nemojte protresati vrećicu.
English: Once opened this medicine must be used immediately.
Croatian: Nakon otvaranja, ovaj lijek se mora odmah primijeniti.
English: 3) or severely immunocompromised patients.
Croatian: 3) niti teško imunokompromitirane bolesnike.
English: Other types of skin infections have not been studied.
Croatian: Nisu ispitane druge vrste kožnih infekcija.
English: • Itching all over the body
Croatian: • svrbež po cijelom tijelu
English: Resistance to antibiotics
Croatian: Otpornost na antibiotike
English: Susceptible (≤S) Resistant (R>)
Croatian: Osjetljivi (≤S) Rezistentni (R>)
English: A risk to the breast-feeding infant cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2 međutim nije moguće dati preporuku o doziranju.
English: If you stop taking Sivextro without the advice of your doctor, your symptoms may get worse.
Croatian: Ako prestanete uzimati Sivextro bez savjeta liječnika, Vaši simptomi bi se mogli pogoršati.
English: The bag should not be shaken.
Croatian: Vrećica se ne smije protresati.
English: You should take all 6 tablets to complete your course of treatment, even if you have missed a dose.
Croatian: Morate uzeti svih 6 tableta da biste dovršili terapiju, čak i ako ste propustili dozu.
English: Sivextro will be given to you by a nurse or doctor.
Croatian: Sivextro će Vam dati medicinska sestra ili liječnik.
English: Date of first authorisation: 23 March 2015 Date of latest renewal:
Croatian: Datum prvog odobrenja: 23. ožujka 2015.