FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel mnenje.
English: • If you require such treatment, your dentist will use other methods available which do not contain arsenic.
Slovenian: • Če potrebujete tovrstno zdravljenje, bo zobozdravnik uporabil druga razpoložljiva sredstva, ki ne vsebujejo arzena.
English: The review of Caustinerf arsenical, Yranicid arsenical and associated names was initiated on 24 October 2013 at the request of the French medicines agency, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil Caustinerf arsenical in Yranicid arsenical ter povezanih imen se je začel dne 24. oktobra 2013 na zahtevo francoske agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
English: During the review, the CHMP considered measures to minimise the risks identified with these products but concluded that restrictions and additional guidance to dentists would not reduce the risks to an acceptable level.
Slovenian: Odbor CHMP je med pregledom obravnaval ukrepe za zmanjšanje ugotovljenih tveganj, povezanih s tema zdraviloma, vendar je zaključil, da omejitve in dodatna navodila za zobozdravnike ne bi zmanjšala tveganja na sprejemljivo raven.
English: Dentists should use other alternative methods available for removing dental pulp.
Slovenian: Zobozdravniki morajo uporabiti druge metode, ki so na voljo za odstranjevanje zobne pulpe.
English: Seven days later the tooth is re-opened and the infected pulp is surgically removed.
Slovenian: Čez sedem dni se zob ponovno odpre, okužena pulpa pa se kirurško odstrani.
English: In addition, epidemiology studies have shown an association between arsenic and spontaneous abortions and stillbirths.
Slovenian: Poleg tega so epidemiološke študije pokazale, da obstaja povezava med arzenom in spontanimi splavi ter rojstvom mrtvih otrok.
English: They contain 3 active substances: ephedrine hydrochloride, lidocaine and arsenic trioxide (arsenous anhydride).
Slovenian: Vsebujejo 3 zdravilne učinkovine: efedrinhidroklorid, lidokain in arzenov trioksid (arzenov anhidrid).
English: In a review conducted by the Agency's Committee for Medicinal Products for Human Use (CHMP), analyses of data from laboratory and population studies indicate that the arsenic contained in them may pose a risk of genotoxic effects that could increase the risk of cancer.
Slovenian: Med pregledom, ki ga je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji, so analize podatkov iz laboratorijskih in populacijskih študij pokazale, da bi arzen v pastah lahko predstavljal tveganje za genotoksične učinke, ki bi lahko povečali tveganje za raka.
English: The dental pastes are applied to the tooth after the tooth has been opened surgically.
Slovenian: Dentalne paste se nanesejo na zob, potem ko je bil ta kirurško odprt.
English: The CHMP recommendation was sent to the European Commission and on 11 July 2014 the Commission issued a legally binding decision revoking the authorisations for Caustinerf arsenical, Yranicid arsenical and associated names throughout the EU.
Slovenian: Priporočilo odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 11. julija 2014 izdala pravno zavezujoč sklep o preklicu dovoljenj za promet z zdraviloma Caustinerf arsenical in Yranicid arsenical ter povezanimi imeni po vsej EU.
English: In addition, there have been a small number of cases where arsenic is thought to have leaked into the areas around the teeth, causing parts of the tissue to die, including bone (osteonecrosis).
Slovenian: Poleg tega so zabeležili majhno število primerov, ko naj bi arzen uhajal v predele okoli zob, kar je povzročilo odmrtje delov tkiva, vključno s kostjo (osteonekroza).
English: On 25 April 2014, the European Medicines Agency recommended that the marketing authorisations for the dental pastes Caustinerf arsenical, Yranicid arsenical and associated names be revoked in the EU due to concerns over the risk of genotoxic effects (damage to the genetic material in cells) and cell death in tissues around the teeth.
Slovenian: Evropska agencija za zdravila je dne 25. aprila 2014 priporočila, da se dovoljenja za promet z dentalnima pastama Caustinerf arsenical in Yranicid arsenical ter povezanimi imeni v EU prekličejo zaradi zadržkov, povezanih s tveganjem za genotoksične učinke (poškodbe genskega materiala v celicah) in celično smrt v tkivih okoli zob.
English: The risk of arsenic from the dental paste leaking into the general circulation and the tissues surrounding the teeth cannot be excluded.
Slovenian: Tveganja za uhajanje arzena iz dentalne paste v krvni obtok in tkiva okoli zob ni mogoče izključiti.
English: • Caustinerf arsenical and Yranicid arsenical dental pastes will no longer be used for removing damaged nerves in teeth, because they may pose a risk of genotoxic effects (which can cause cancers) and cell death in tissues around the teeth which may be difficult to treat.
Slovenian: • Dentalni pasti Caustinerf arsenical in Yranicid arsenical se ne bosta več uporabljali za odstranjevanje poškodovanih živcev v zobeh, saj bi lahko predstavljali tveganje za genotoksične učinke (ki lahko povzročijo raka) in celično smrt v tkivih okoli zob, ki jo je včasih težko zdraviti.
English: Post-marketing surveillance of Caustinerf arsenical and Yranicid arsenical has identified a small number of cases of periodontal necrosis, including 12 cases of osteonecrosis.
Slovenian: Med spremljanjem zdravil Caustinerf arsenical in Yranicid arsenical v obdobju trženja so odkrili majhno število primerov nekroze obzobnih tkiv, vključno z 12 primeri osteonekroze.
English: Therefore, in the light of current standard of care available, the Committee concluded that the benefits of Caustinerf arsenical and Yranicid arsenical do not outweigh their risks and recommended that their marketing authorisations be revoked.
Slovenian: Odbor je zato ob upoštevanju trenutno razpoložljive standardne oskrbe zaključil, da koristi zdravil Caustinerf arsenical in Yranicid arsenical ne odtehtajo z njima povezanih tveganj, in priporočil preklic dovoljenj za promet z njima.
English: In vitro studies with Caustinerf arsenical and Yranicid arsenical have confirmed a clastogenic/aneugenic potential and there are published data showing that arsenic compounds have a toxic effect on reproduction in animals.
Slovenian: Študije zdravil Caustinerf arsenical in Yranicid arsenical in vitro so potrdile klastogeni/anevgeni potencial, objavljeni pa so tudi podatki, ki kažejo, da imajo arzenove spojine toksičen učinek na sposobnost razmnoževanja pri živalih.
English: The dental pastes, which contain an arsenic-based compound, arsenic trioxide, have been used to remove the damaged nerves in the dental pulp (the inside of the tooth).
Slovenian: Dentalni pasti, ki vsebujeta spojino na osnovi arzena, imenovano arzenov trioksid, sta se uporabljali za odstranjevanje poškodovanih živcev v zobni pulpi (notranjosti zoba).
English: The EMA recommendations are based on a review of data indicating a potential genotoxic effect of the products due to the presence of arsenic trioxide (arsenous anhydride).
Slovenian: Priporočila Evropske agencije za zdravila temeljijo na pregledu podatkov, ki kažejo, da bi lahko zdravili zaradi vsebnosti arzenovega trioksida (arzenovega anhidrida) imeli genotoksične učinke.
English: Caustinerf arsenical, Yranicid arsenical and associated names are dental pastes that have been used in procedures to remove the damaged nerves in the dental pulp.
Slovenian: Zdravili Caustinerf arsenical in Yranicid arsenical ter povezana imena so dentalne paste, ki so se uporabljale pri posegih za odstranitev poškodovanih živcev v zobni pulpi.
English: The EMA has concluded that the benefits of Caustinerf arsenical, Yranicid arsenical and associated names do not outweigh their risks and has recommended that their marketing authorisations in the EU be revoked.
Slovenian: Evropska agencija za zdravila je zaključila, da koristi zdravil Caustinerf arsenical in Yranicid arsenical ter povezanih imen ne odtehtajo z njimi povezanih tveganj, in priporočila preklic dovoljenj za promet z njimi v EU.
English: WHEREAS
Slovenian: KER
English: INTRODUCTION
Slovenian: UVOD
English: The CHMP is of the Opinion that Hexavac, can no longer be maintained in normal clinical usage for the following reasons:
Slovenian: Odbor za zdravila za uporabo v humani medicini meni, da Hexavaca ni več mogoče ohranjati v običajni klinični uporabi iz naslednjih razlogov:
English: The CHMP was requested to give an opinion as to whether the marketing authorisation for Hexavac should be maintained, varied, suspended or withdrawn in the context of an Article 18 of Council Regulation (EEC) No 2309/93, as amended, procedure.
Slovenian: Odbor za zdravila za uporabo v humani medicini je prejel prošnjo, da izrazi mnenje o tem, ali bi bilo treba dovoljenje za promet z zdravilom Hexavac vzdrževati, spremeniti, ukiniti ali dovoljenje odvzeti v smislu postopka, ki ga določa 18. člen Uredbe Sveta (EGS) št. 2309/93, kot je bila spremenjena.
English: DISCUSSION
Slovenian: RAZPRAVA
English: These findings were based on a rather limited number of infants but raised concerns because the findings of a challenge ‘weaker' than priming with or without booster dose are unexpected.
Slovenian: Te ugotovitve so temeljile na precej omejenem številu otrok, vendar so zbujale skrb zato, ker so rezultati stimulacije, ki je 'šibkejša' kot primarno cepljenje z obnovitvenim odmerkom ali brez njega, nepričakovani.
English: CONCLUSION
Slovenian: ZAKLJUČEK
English: The MAH proposed also to perform additional studies and further develop the Hepatitis B surveillance programme.
Slovenian: Imetnik dovoljenja za promet z zdravilom je tudi predlagal, da bi opravili dodatne raziskave in nadalje razvili program za nadzor hepatitisa B.
English: On the other hand, there are currently no reports on Hepatitis B breakthrough cases after Hexavac vaccination, considering that the EU is a low endemic region and individual risks would potentially increase only later in life.
Slovenian: Po drugi strani pa zaenkrat ni nobenih poročil o pojavu primerov hepatitisa B po cepljenju s Hexavacom, ob upoštevanju tega, da je EU območje z nizko endemičnostjo in da se tveganja pri posameznikih lahko povečajo le v kasnejšem obdobju življenja.
English: The CHMP considered that clinical alternatives exist, i.e. hexavalent vaccines or equivalent combinations of vaccines containing the same components as Hexavac.
Slovenian: Odbor za zdravila za uporabo v humani medicini meni, da klinične alternative obstajajo, in sicer heksavalentna cepiva ali enakovredne kombinacije cepiv, ki vsebujejo enake sestavine kot Hexavac.
English: Furthermore, the proposed amendments to the PI wording were insufficient to adequately address negative consequences on HepB efficacy resulting from variances in the manufacturing process.
Slovenian: Nadalje, predlagane spremembe Informacij o zdravilu ne zadostujejo za to, da bi z njimi lahko zadovoljivo odpravili negativne posledice za učinkovitost HepB sestavine, ki izhajajo iz razlik v postopku izdelave.
English: Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, polio virus and Haemophilus influenzae type b. This combined vaccine is indicated for primary and booster vaccination of children against the viruses and bacteria mentioned above.
Slovenian: Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, pridobljene iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, poliovirusa in Haemophilus influenzae tipa b. To kombinirano cepivo je indicirano za primarno in obnovitveno cepljenje otrok proti zgoraj omenjenim virusom in bakterijam.
English: The MAH proposed the development of strategies to identify the source of the problem, as well as to produce a more immunogenic formulation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal pripravo strategij za ugotavljanje izvora problema kot tudi za pripravo formulacije z večjo imunogenostjo.
English: Continuous efforts are being made to improve the immunogenicity of the HepB component of Hexavac.
Slovenian: Ugotovljena so bila nenehna prizadevanja za izboljšanje imunogenosti HepB sestavine Hexavaca.
English: Infants with an initial immune response between 10 and 100 mIU/ml anti HBsAg responded less efficiently or not at all to a single dose of monovalent Hepatitis B vaccine given at the age of 7-9 years, compared to those with initial titres between 100 and 1000 mIU/ml.
Slovenian: Pri otrocih, pri katerih se je začetni imunski odziv nahajal med 10 in 100 mIE/ml proti HbsAg, je v primerjavi z otroki, pri katerih so se začetni titri nahajali med 100 in 1000 mIE/ml, po enkratnem odmerku monovalentnega cepiva proti hepatitisu B, danega pri starosti 7 do 9 let, prišlo do manj učinkovitega odziva ali pa odziva sploh ni bilo.
English: Furthermore, the MAH has proposed to change the Product Information (PI), namely separate administration of pneumococcal and meningococcal conjugate vaccines.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom podal predlog za spremembo Informacij o zdravilu (Product Information, PI), in sicer, ločeno dajanje pnevmokoknih in meningokoknih konjugiranih cepiv.
English: Critical steps of the manufacturing process have been investigated by the marketing authorisation holder (MAH), and a modified process step was identified as the most likely strategy to enhance immunogenicity of the HepB component.
Slovenian: Imetnik dovoljenja za promet z zdravilom je preiskal kritične stopnje postopka izdelave in sprememba stopnje v postopku se je pokazala kot najverjetnejša strategija za povečanje imunogenosti HepB sestavine.
English: These facts were put into perspective with the clinical consequences observed so far and the apparent low benefits and uncertainties obtained from the Hepatitis B vaccination utilising Hexavac for the target population.
Slovenian: Ta dejstva so bila preučena z vidika doslej opaženih kliničnih posledic in očitnih majhnih koristi ter negotovosti, ki jih za ciljno populacijo prinaša cepljenje proti hepatitisu B s Hexavacom.
English: Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with Hexavac, the CHMP recommended the suspension for the Marketing Authorisation of Hexavac.
Slovenian: Ob upoštevanju vseh omenjenih dejavnikov, vključno s časovnim okvirom, ki je potreben za popolno preiskavo vseh vprašanj, povezanih z nizko imunogenostjo HepB sestavine po cepljenju s Hexavacom, je Odbor za zdravila za uporabo v humani medicini priporočil ukinitev dovoljenja za promet z zdravilom Hexavac.
English: Between July and September 2005, the marketing authorisation holder gave oral explanations to the CHMP and its working parties on the low immunogenicity of the HepB component in long-term protection against Hepatitis B afforded by Hexavac.
Slovenian: Med julijem in septembrom 2005 je imetnik dovoljenja za promet z zdravilom Odboru za zdravila za uporabo v humani medicini in njegovim delovnim skupinam dal ustna pojasnila glede nizke imunogenosti HepB sestavine pri dolgotrajni zaščiti pred hepatitisom B, ki jo nudi Hexavac.
English: Reference was made to the highly variable quality of the HepB component contained in Hexavac emerging from a manufacturing production in which the root cause of the low immunogenicity has failed to be identified.
Slovenian: Ugotovljene so bile velike razlike v kakovosti HepB sestavine, ki jo vsebuje Hexavac, kar izhaja iz postopka izdelave, pri katerem pa temeljnega vzroka za nizko imunogenost ni bilo mogoče ugotoviti.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATION OF HEXAVAC PRESENTED BY THE EMEA
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UKINITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM HEXAVAC, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Notwithstanding the MAH proposals, the CHMP considered that the applicability of the MAH proposals need to be substantiated by data, which validity needs to be determined.
Slovenian: Ne glede na predloge imetnika dovoljenja za promet z zdravilom pa je bil Odbor za zdravila za uporabo v humani medicini mnenja, da bi bilo treba primernost predlogov imetnika dovoljenja za promet z zdravilom podpreti s podatki, katerih veljavnost je treba ugotoviti.
English: Additional concerns were raised by the recent finding that children primary immunised with Hexavac apparently respond to a booster dose of a monovalent Hepatitis B vaccine as a function of the geometric mean titres (GMTs) achieved upon completion of the primary immunisation series.
Slovenian: Dodatno zaskrbljenost je povzročila nedavna ugotovitev, da pri otrocih, ki so bili primarno cepljeni s Hexavacom, očitno pride do odziva na obnovitveni odmerek monovalentnega cepiva proti hepatitisu B in sicer v odvisnosti od titrov geometričnih povprečij (GMT), doseženih po zaključku serij primarnega cepljenja.
English: Nevertheless, in accordance with the current knowledge, the CHMP considers that childhood Hepatitis B vaccines should be as immunogenic as possible necessitating a maximum of a single booster dose during adolescence to ensure protective efficacy at the time vaccinated subjects might be exposed to a higher risk of infection compared to infancy and childhood.
Slovenian: Kljub vsemu pa Odbor za zdravila za uporabo v humani medicini skladno s trenutno razpoložljivim znanjem meni, da morajo biti cepiva proti hepatitisu B, ki se uporabljajo v otroštvu, imunogena v največji možni meri in morajo zahtevati največ en obnovitveni odmerek med adolescenco za zagotovitev učinkovite zaščite v obdobju, v katerem bi cepljeni posamezniki lahko bili izpostavljeni večjemu tveganju okužbe v primerjavi z najzgodnejšim obdobjem življenja in otroštvom.
English: GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATION OF HEXAVAC
Slovenian: PODLAGA ZA UKINITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM HEXAVAC
English: These observations led to an intensive investigation programme agreed by the MAH to identify the reason for the lower immune response.
Slovenian: Te ugotovitve so vodile k temeljitemu raziskovalnemu programu za odkrivanje vzroka za manjši imunski odziv, s čimer se je strinjal imetnik dovoljenja za promet z zdravilom.
English: This variability seems to be related to currently uncontrollable variances in the manufacturing process of the recombinant HepB vaccine component.
Slovenian: Ta variabilnost je domnevno povezana z razlikami v postopkih izdelave HepB sestavine rekombinantnega cepiva, ki jih je zaenkrat nemogoče nadzorovati.
English: • The CHMP considered that the benefit/risk balance of Hexavac for primary and booster vaccination of children against diphtheria, tetanus, pertussis, Hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type
Slovenian: • Odbor za zdravila za uporabo v humani medicini je mnenja, da razmerje med koristmi in tveganji uporabe Hexavaca za primarno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, ki ga povzročajo vse znane podvrste virusov, poliomielitisu in invazivnim okužbam, ki jih povzroča Haemophilus influenzae tipa b, ni ugodno.
English: The CHMP has recommended the suspension of the Marketing Authorisations for Hexavac.
Slovenian: Odbor za zdravila za uporabo v humani medicini predlaga ukinitev dovoljenja za promet z zdravilom Hexavac.
English: Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine.
Slovenian: Izražena je bila zaskrbljenost zaradi nizke imunogenosti HepB sestavine, ki jo vsebuje Hexavac, in zaradi morebitnih posledic dolgotrajne zaščite pred okužbo s hepatitisom B ter obnovitvenega cepljenja po primarnem cepljenju s tem cepivom.
English: The MAH reiterated their commitment to establish a test to discriminate batches of Hexavac which have elucidated a good vs. an insufficient immune response during clinical trials.
Slovenian: Imetnik dovoljenja za promet z zdravilom je večkrat izrazil svoje zavzemanje za razvoj preizkusa, s katerim bi bilo mogoče razlikovati med serijami Hexavaca z dobrim in tistimi z nezadostnim imunskim odzivom med kliničnimi preizkušanji.
English: The concerns over the immunogenicity of the HepB component increased when lower than expected seroconversion rates were observed following the concomitant administration of Hexavac with other meningococcal and pneumococcal vaccines.
Slovenian: Zaskrbljenost glede imunogenosti HepB sestavine je narasla, ko so po sočasnem dajanju Hexavaca skupaj z drugimi meningokoknimi in pnevmokoknimi cepivi ugotovili, da so bile vrednosti serokonverzije manjše od pričakovanih.
English: On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
Slovenian: Odbor za zdravila za uporabo v humani medicini je 26. maja 2005 soglašal s tem, da je potrebno sklicati sestanek ad hoc izvedenske skupine za kratkotrajno in dolgotrajno zaščito pred hepatitisom, ki jo omogočajo rekombinantna cepiva proti hepatitisu B. Odbor za zdravila za uporabo v humani medicini je izrazil zaskrbljenost, ker obstajajo dokazi o nepredvidljivi variabilnosti odziva protiteles hepatitisa B po cepljenju s Hexavacom.
English: • Considering the data on low immunogenicity available today, the CHMP identified a potential risk associated to continued vaccination with Hexavac, in terms of long-term protection against Hepatitis B infection and subject boostability post priming with Hexavac.
Slovenian: • Ob upoštevanju podatkov o nizki imunogenosti, ki so danes na voljo, je Odbor za zdravila za uporabo v humani medicini ugotovil potencialno tveganje, povezano s ponavljajočim se cepljenjem s Hexavacom v smislu dolgotrajne zaščite pred okužbo s hepatitisom B in obnovitvenim cepljenjem posameznika po primarnem cepljenju s Hexavacom.
English: Issues pertaining to the relatively low immunogenicity of the Hepatitis B (HepB) component contained in Hexavac have been assessed and extensively discussed by the CHMP and its Working Parties (Biotechnology Working Party, Vaccines Working Party).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) in njegove delovne skupine (Delovna skupina za biotehnologijo, Delovna skupina za cepiva) so ocenili in izčrpno razpravljali o vprašanjih, ki se nanašajo na relativno nizko imunogenost hepatitis B (HepB) sestavine, ki jo vsebuje Hexavac.
English: Overall, the CHMP considered the multifactorial nature of the low immunogenicity of the HepB component in Hexavac.
Slovenian: Odbor za zdravila za uporabo v humani medicini je preučil naravo nizke imunogenosti HepB sestavine v Hexavacu, ki je odvisna od več dejavnikov.
English: On 14 September 2005, the European Commission (EC) triggered the procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Hexavac.
Slovenian: Ko je Odbor za zdravila za uporabo v humani medicini izrazil zaskrbljenost zaradi nizke imunogenosti HepB sestavine Hexavaca, je Evropska komisija 14. septembra 2005 sprožila postopek po 18. členu Uredbe Sveta (EGS) št. 2309/93, kot je bila spremenjena.
English: The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
Slovenian: Odbor za zdravila za uporabo v humani medicini je ugotovil, da je zmanjšana imunogenost HepB sestavine, ki jo je na tržišče dal imetnik dovoljenja za promet z zdravilom, posledica razlik v postopku izdelave te sestavine.