FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Odbor je menil, da možnost genotoksičnih in rakotvornih učinkov ter učinkov na sposobnost razmnoževanja zaradi sistemske izpostavljenosti arzenovemu trioksidu ob pomanjkljivem vedenju o tem, kakšna je stopnja sistemske izpostavljenosti po dentalni uporabi paste, ki vsebuje arzenov trioksid, ni sprejemljiva.
English: The MAHs did not recently conduct any clinical trial with arsenic trioxide in dental paste.
Slovenian: Imetnika dovoljenja za promet z zdravilom v zadnjem času nista izvedla nobenega kliničnega preskušanja z arzenovim trioksidom v dentalni pasti.
English: • restrict the indication to the second line use;
Slovenian: • omejitev indikacije na uporabo teh zdravil kot zdravil druge izbire;
English: The CHMP acknowledges that:
Slovenian: Odbor CHMP je ugotovil:
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).
Slovenian: • odbor CHMP je obravnaval napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za zdravili Caustinerf arsenical in Yranicid arsenical ter druga povezana imena za lokalno zdravljenje (glejte Prilogo I);
English: • the risk of necrosis to periodontal tissues is high in comparison to the other serious adverse events and the necrosis of periodontal tissues together with infectious complications remain a very serious known adverse effect, hard to treat and difficult to control despite the SmPC
Slovenian: • da je tveganje za nekrozo obzobnih tkiv veliko v primerjavi s tveganjem za druge resne neželene dogodke in da je nekroza obzobnih tkiv skupaj z zapleti zaradi okužb še vedno zelo resen znan neželeni učinek, ki ga je kljub priporočilom v povzetku glavnih značilnosti zdravila težko zdraviti in nadzorovati.
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.
Slovenian: • da so poročali o številnih primerih osteonekroze, nekroze mehkih tkiv in zobne pulpe, fistule na kosti ter razbarvanja dlesni, ki veljajo za resne neželene učinke, njihovo zdravljenje pa je zelo zapleteno;
English: The risk of genotoxicity including human fertility, foetal development and carcinogenicity induced by arsenic trioxide was reviewed.
Slovenian: Opravljen je bil pregled tveganja za genotoksičnost, ki je vključeval plodnost pri človeku, razvoj ploda in rakotvornost, ki jo povzroča arzenov trioksid.
English: In addition, the Committee is of the view that the risk of tissue necrosis cannot be ruled out even under the conditions of careful dental practice and the proposed SmPC recommendations.
Slovenian: Poleg tega je odbor menil, da tveganja za nekrozo tkiv ni mogoče izključiti niti v primeru previdne uporabe v zobozdravstveni praksi in upoštevanja predlaganih priporočil v povzetku glavnih značilnosti zdravila.
English: Overall summary of the scientific evaluation of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Caustinerf arsenical in Yranicid arsenical ter drugih povezanih imen za lokalno zdravljenje (glejte Prilogo I)
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.
Slovenian: Sočasno je imetnik dovoljenja za promet z zdravilom izvedel nove analize genotoksičnosti (Amesov test ter mikronukleusni test in vitro) z izvlečki dentalne paste Caustinerf arsenical in zabeležil pozitivne rezultate samo pri mikronukleusnem testu in vitro.
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.
Slovenian: • odbor CHMP je upošteval genotoksičnost arzenovega trioksida in da je njegova uporaba povezana z možnim tveganjem za rakotvornost ter resne neželene učinke, kot je nekroza tkiv, ki ima včasih lahko posledice;
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.
Slovenian: Potem ko je proučil vse razpoložljive podatke iz predkliničnih in kliničnih študij, objavljene literature in izkušenj v obdobju trženja, povezane z zdraviloma Caustinerf arsenical in Yranicid arsenical ter drugimi povezanimi imeni za lokalno zdravljenje, ki sta jih zagotovila imetnika dovoljenja za promet z zdravilom v pisni dokumentaciji in med ustno obrazložitvijo, je odbor menil, da je uporaba zdravil Caustinerf arsenical in Yranicid arsenical ter drugih povezanih imen za lokalno zdravljenje povezana s tveganji za rakotvornost in resne neželene učinke, povezane z nekrozo, ki ima včasih lahko posledice.
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.
Slovenian: Odbor CHMP je proučil spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom in ki naj bi zmanjšale omenjena tveganja, ter zaključil, da s temi ukrepi za zmanjšanje tveganja ne bi bilo mogoče zmanjšati tveganj za resne neželene učinke na klinično sprejemljivo raven.
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.
Slovenian: Pri ocenjevanju je odbor CHMP upošteval vse razpoložljive podatke, ki sta jih predložila imetnika dovoljenja za promet z zdravilom, ter objavljeno literaturo in podatke, ki so na voljo državam članicam.
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.
Slovenian: Med razpravami so obravnavali ukrepe za zmanjšanje tveganja, ki sta jih predlagala imetnika dovoljenja za promet z zdravilom in med katerimi so bile spremembe informacij o zdravilu (omejitev uporabe, dodatne kontraindikacije pri pediatrični populaciji ter med nosečnostjo in dojenjem), gradivo za obveščanje ter študija o varnosti zdravila po pridobitvi dovoljenja za promet (PASS).
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.
Slovenian: Ker z zdravilom Caustinerf arsenical ali Yranicid arsenical niso bile izvedene nobene študije o vplivu na sposobnost razmnoževanja pri živalih, sta imetnika dovoljenja za promet z zdravilom predložila še kratek pregled razpoložljivih podatkov iz znanstvene literature v zvezi z učinki anorganskega arzena na sposobnost razmnoževanja.
English: Zizine) which revealed a potential of genotoxicity related to the use of arsenic trioxide.
Slovenian: Zizine) sta opravila pregled literature, ki je razkril možnost genotoksičnosti, povezane z uporabo arzenovega trioksida.
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;
Slovenian: o da se indikacija omeji tako, da se bodo zdravila uporabljala kot zdravila zadnje izbire, tj. takrat, ko tehnike anestezije niso na voljo ali pa jih ni mogoče uporabiti pri bolnikih iz EU, o da se kontraindicira uporaba zdravil pri otrocih, nosečnicah in ženskah, ki dojijo, o da se poudarijo revidirana indikacija in lokalni pogoji, zapiranje zdravljene votline, s katerim se bo čim bolj zmanjšalo neposredno uhajanje materiala in pronicanje arzena, skrajšanje izpostavljenosti (3 dni namesto 7 dni) ob skrbnem spremljanju in opozorilo glede pojava bolečine;
English: On 24 October 2013, the CHMP started a referral procedure for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use.
Slovenian: Odbor CHMP je dne 24. oktobra 2013 začel napotitveni postopek za zdravili Caustinerf arsenical in Yranicid arsenical ter druga povezana imena za lokalno zdravljenje.
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.
Slovenian: Imetnika dovoljenja za promet z zdravilom sta izvedla preskuse in vitro, da bi ocenila genotoksičnost zdravila Caustinerf arsenical, ter predložila rezultate izčrpnega pregleda vpliva arzenovih spojin na somatske celice, ki ga je opravil strokovnjak na področju toksikologije.
English: The CHMP therefore concluded that the benefit-risk balance of arsenic trioxide containing medicinal products is not favourable.
Slovenian: Zato je odbor CHMP zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo arzenov trioksid, ni ugodno.
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.
Slovenian: • odbor CHMP je menil, da so razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvotnih dovoljenj za promet z zdraviloma Caustinerf arsenical in Yranicid arsenical ter drugimi povezanimi imeni za lokalno zdravljenje, pri odobreni indikaciji omejeni;
English: • no clinical practice guideline endorses the use of arsenic dental paste,
Slovenian: • da uporabe dentalne paste, ki vsebuje arzen, ne podpirajo nobene smernice klinične prakse;
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.
Slovenian: Imetnika dovoljenja za promet z zdravilom sta potrdila, da sta predložila vse razpoložljive podatke in da ne bosta mogla predložiti nobenih dodatnih podatkov, ki bi dokazovali klinično korist zdravil Caustinerf arsenical in Yranicid arsenical ter drugih povezanih imen za lokalno zdravljenje pri lokalni anesteziji.
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.
Slovenian: • odbor CHMP je proučil vse podatke, ki so na voljo za zdravili Caustinerf arsenical in Yranicid arsenical ter druga povezana imena za lokalno zdravljenje, v zvezi z genotoksičnostjo in tveganjem za rakotvornost.
English: Finally the CHMP noted that no national, European and international guideline endorse the use of arsenic dental paste in clinical practice.
Slovenian: Odbor CHMP je poudaril še, da uporabe dentalne paste, ki vsebuje arzen, v klinični praksi ne podpirajo nobene nacionalne, evropske ali mednarodne smernice.
English: Grounds for revocation of the marketing authorisations of Caustinerf arsenical, Yranicid arsenical and associated names for topical use
Slovenian: Podlaga za preklic dovoljenj za promet z zdraviloma Caustinerf arsenical in Yranicid arsenical ter povezanimi imeni za lokalno zdravljenje
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.
Slovenian: Odbor CHMP je menil, da sta zdravili Caustinerf arsenical in Yranicid arsenical ter druga povezana imena za lokalno zdravljenje povezani z možnimi tveganji za rakotvornost in nekrozo tkiv ter kažejo omejeno učinkovitost pri odobreni indikaciji.
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.
Slovenian: • odbor CHMP je zato na podlagi razpoložljivih podatkov zaključil, da genotoksičnost in tveganje za rakotvornost ter nekrozo tkiv, povezana z uporabo zdravil Caustinerf arsenical in Yranicid arsenical ter povezanih imen za lokalno zdravljenje pri neboleči lokalni devitalizaciji zobne pulpe odtehtata omejene koristi.
English: Caustinerf arsenical, Yranicid arsenical and other associated names for topical use are indicated in the painless topical devitalisation of the dental pulp.
Slovenian: Zdravili Caustinerf arsenical in Yranicid arsenical ter druga povezana imena za lokalno zdravljenje so indicirana za nebolečo lokalno devitalizacijo zobne pulpe.
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.
Slovenian: • vključitev opozorila v zadevnem poglavju povzetka glavnih značilnosti zdravila, da tveganja za rakotvornost ni mogoče izključiti in da obstaja tveganje za nekrozo obzobnih tkiv.
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.
Slovenian: • odbor CHMP je upošteval mnenje imetnika dovoljenja za promet z zdravilom, da so bili predloženi vsi razpoložljivi podatki in da ni mogoče predložiti nobenih dodatnih podatkov, ki bi dokazovali klinično korist zdravil Caustinerf arsenical in Yranicid arsenical ter povezanih imen za lokalno zdravljenje pri neboleči lokalni devitalizaciji zobne pulpe;
English: recommendations.
Slovenian: Znanstveni zaključki
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.
Slovenian: Odbor CHMP je zato zaključil, da razmerje med tveganji in koristmi zdravil Caustinerf arsenical in Yranicid arsenical ter drugih povezanih imen za lokalno zdravljenje pri indikaciji „neboleča lokalna devitalizacija zobne pulpe“ ni ugodno.
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.
Slovenian: Posledično je odbor CHMP zaključil, da razmerje med tveganji in koristmi za zdravili Caustinerf arsenical in Yranicid arsenical ter povezana imena za lokalno zdravljenje ni ugodno.
English: Even in case of the best practice the necrotic adverse reactions cannot be ruled out due to the specifics of dental anatomy or accidental spillage.
Slovenian: Neželenih učinkov, povezanih z nekrozo, zaradi posebne zgradbe zob ali nenamernega razlitja ni mogoče izključiti niti v primeru najboljše prakse.
English: The CHMP took in account the MAH's position.
Slovenian: Odbor CHMP je upošteval mnenje imetnika dovoljenja za promet z zdravilom.
English: Your doctor will explain more.
Slovenian: Zdravnik vam bo razložil več o tem.
English: 3) have not been investigated.
Slovenian: 3) nista raziskani.
English: The clinical relevance of this finding is unknown.
Slovenian: Klinični pomen te ugotovitve ni znan.
English: This medicine should not be used in children and adolescents as it has not been studied enough in these populations.
Slovenian: To zdravilo se ne sme uporabljati pri otrocih in mladostnikih, ker pri tej populaciji ni bilo dovolj raziskano.
English: A risk to the breast-feeding infant cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: It is especially important that you tell your doctor if you are also taking:
Slovenian: Še zlasti je pomembno, da zdravniku poveste, če jemljete:
English: Once opened this medicine must be used immediately.
Slovenian: Ko je zdravilo odprto, ga je treba uporabiti takoj.
English: Other types of skin infections have not been studied.
Slovenian: Drugih vrst kožnih okužb niso preučevali.
English: • Allergic reaction
Slovenian: • alergijska reakcija
English: The eGFR was calculated using the MDRD4 equation.
Slovenian: Vrednost eGFR je bila izračunana z uporabo enačbe MDRD4.
English: Resistance to antibiotics
Slovenian: Odpornost na antibiotike
English: The film-coated tablets can be taken with or without food.
Slovenian: Filmsko obložene tablete se lahko jemljejo s hrano ali brez nje.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo protibakterijskih učinkovin.
English: It works by stopping the growth of certain bacteria which can cause serious infections.
Slovenian: Deluje tako, da zaustavi razraščanje določenih bakterij, ki lahko povzročijo hude okužbe.
English: If a rapid antibiotic effect is needed, the intravenous administration should be considered.
Slovenian: Če je potreben hiter antibiotični učinek, je treba razmisliti o intravenski aplikaciji.
English: Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Slovenian: Pomembno: pred predpisovanjem prosimo preberite povzetek glavnih značilnosti zdravila (SmPC).
English: Sivextro will be given to you by a nurse or doctor.
Slovenian: Zdravilo Sivextro vam bosta dala medicinska sestra ali zdravnik.
English: 6 vials
Slovenian: 6 vial
English: Reconstituted solutions containing visible particles should be discarded.
Slovenian: Rekonstituirane raztopine, ki vsebujejo vidne delce, je treba zavreči.
English: Other side effects may include:
Slovenian: Med drugimi neželenimi učinki so:
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Slovenian: Mejne vrednosti minimalnih inhibitornih koncentracij (MIK), ki jih je določil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST - European Committee on Antimicrobial Susceptibility Testing), so:
English: The bag should not be shaken.
Slovenian: Vrečke se ne sme stresati.
English: • Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)
Slovenian: • Skupina Streptococcus anginosus (vključuje S. anginosus, S. intermedius in S. constellatus)
English: Available in packs of 1 vial and 6 vials.
Slovenian: Na voljo v pakiranjih po 1 viala in 6 vial.
English: The clinical experience in patients ≥75 years is limited.
Slovenian: Kliničnih izkušenj pri bolnikih, starih 75 let ali več, je malo.
English: Bacteria can become resistant to treatment with antibiotics over time.
Slovenian: Bakterije lahko sčasoma postanejo odporne na zdravljenje z antibiotiki.
English: The absolute bioavailability of tedizolid is above 90%.
Slovenian: Absolutna biološka uporabnost tedizolida je več kot 90 %.
English: • anaemia (low red blood cells)
Slovenian: • anemijo (majhno število rdečih krvnih celic),
English: • Itching all over the body
Slovenian: • srbenje po celem telesu
English: Peel, then push
Slovenian: Odlepite in nato potisnite
English: Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.
Slovenian: Zdravljenje s protibakterijskimi učinkovinami spremeni normalno floro debelega črevesa in lahko omogoči čezmerno razraščanje C. difficile.
English: • if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na tedizolid fosfat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Tedizolid demonstrated linear pharmacokinetics with regard to dose and time.
Slovenian: Tedizolid kaže linearno farmakokinetiko glede na odmerek in čas.
English: Other than tedizolid, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites.
Slovenian: Poleg tedizolida, ki predstavlja približno 95 % vrednosti AUC vsega radioaktivnega ogljika v plazmi, v obtoku ni drugih pomembnih presnovkov.
English: Medicinal products inhibiting peristalsis are contraindicated in this situation.
Slovenian: Zdravila, ki zavirajo peristaltiko, so v teh okoliščinah kontraindicirana.
English: Pharmacokinetic studies were conducted in healthy volunteers and population pharmacokinetic analyses were conducted in patients from Phase 3 studies.
Slovenian: Farmakokinetične študije so bile izvedene pri zdravih prostovoljcih, populacijske farmakokinetične analize pa pri bolnikih iz študij 3. faze.
English: Do not use Sivextro:
Slovenian: Ne uporabljajte zdravila Sivextro:
English: If you stop taking Sivextro without the advice of your doctor, your symptoms may get worse.
Slovenian: Če ste prenehali jemati zdravilo Sivextro, čeprav vam tega ni svetoval zdravnik, se vaši simptomi lahko poslabšajo.
English: Intravenous use after reconstitution and dilution For single use only
Slovenian: za intravensko uporabo po rekonstituciji in redčenju samo za enkratno uporabo
English: The potential for serotonergic interactions has not been studied in either patients or healthy volunteers (see section 5.2).
Slovenian: Verjetnosti za serotoninergično medsebojno delovanje niso preučevali niti pri bolnikih niti pri zdravih prostovoljcih (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, druge protimikrobne učinkovine, oznaka ATC: J01XX11
English: Non-susceptible microorganisms
Slovenian: Neobčutljivi mikroorganizmi
English: Elderly population (≥65 years)
Slovenian: Starejša populacija (≥ 65 let)
English: The combined storage time (from reconstitution to dilution to administration) must not exceed 24 hours when stored at either room temperature or in a refrigerator (2°C - 8°C).
Slovenian: Skupen čas shranjevanja (od rekonstitucije do redčenja do uporabe) ne sme presegati 24 ur, če je shranjeno ali pri sobni temperaturi ali v hladilniku (2 °C - 8 °C).
English: The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at least 16 times that in immunocompetent animals (see section 4.4).
Slovenian: Razmerje AUC/MIK za dosego bakteriostaze pri nevtropeničnih miših je bilo za vsaj 16-krat večje kot pri imunokompetentnih živalih (glejte poglavje 4.4).
English: • Abnormal smelling urine, abnormal blood tests
Slovenian: • nenormalen vonj urina, nenormalni izvidi krvnih preiskav