FrancophonIA/ELRC3.0 huggingface dataset:
English: Part II.1.d) of Annex I of Directive 2001/83/EC is states that “ the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Slovenian: V delu II(1)(d) Priloge I k Direktivi 2001/83/ES je navedeno, da je treba „v pregledih neklinične in/ali klinične dokumentacije obrazložiti pomembnost vseh predloženih podatkov o zdravilu, ki se razlikuje od zdravila, namenjenega za trženje.
English: The experts reports submitted during the referral procedure suggest that that there could be a slightly lower exposure to loratadine, based on the results of the supportive pharmacokinetic study provided by the MAH.
Slovenian: Strokovna poročila, ki so bila predložena med napotitvenim postopkom, kažejo, da bi bila izpostavljenost loratadinu lahko nekoliko nižja, in sicer na podlagi rezultatov podporne farmakokinetične študije, ki jo je zagotovil imetnik dovoljenja za promet z zdravilom.
English: the CHMP has recommended the refusal of the granting of the marketing authorisation for Loraxin and associated names (see Annex I).
Slovenian: CHMP je priporočil, da se izdaja dovoljenja za promet z zdravilom Loraxin in povezanimi imeni zavrne (glej Prilogo I).
English: During the re-examination procedure, the MAH did not demonstrate adequately that the published literature of loratadine is directly applicable to Loraxin.
Slovenian: Imetnik dovoljenja za promet z zdravilom med postopkom ponovnega pregleda ni zadovoljivo dokazal, da se objavljena literatura o loratadinu lahko neposredno uporablja za Loraxin.
English: Loratadine is not a BCS class I (high solubility-high permeability) or III ((high solubility-low permeability) substance, which might otherwise have supported an extrapolation based on the pharmaceutical data.
Slovenian: Loratadin ni snov, ki bi se po klasifikaciji BCS uvrščala v razred I (dobra topnostdobra permeabilnost) ali III (dobra topnost-slaba permeabilnost), s čimer bi bilo sicer mogoče utemeljiti ekstrapolacijo na podlagi farmacevtskih podatkov.
English: Instead, as it is a BCS class II (low solubility-high permeability) or IV (low solubility-low permeability) substance additional data would be needed to support the relevance of the bibliographic data to demonstrate efficacy and safety of Loraxin.
Slovenian: Ker se snov po klasifikaciji BCS uvršča v razred II (slaba topnost-dobra permeabilnost) ali IV (slaba topnost-slaba permeabilnost), so potrebni dodatni podatki, s katerimi bi bilo mogoče podpreti pomembnost bibliografskih podatkov za dokazovanje učinkovitosti in varnosti Loraxina.
English: As it could not be established whether a potentially lower or higher exposure to loratidine compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature would constitute any efficacy or safety concerns, the CHMP therefore maintained its concern that this is a potential serious risk to public health.
Slovenian: Ker ni bilo mogoče ugotoviti, ali bi lahko morebitna nižja ali višja izpostavljenost loratadinu v primerjavi z izpostavljenostjo, ki je bila dosežena po aplikaciji zdravila, uporabljenega v temeljnih kliničnih študijah, opisanih v predloženi literaturi, vzbudila pomisleke glede učinkovitosti ali varnosti, je CHMP vztrajal pri svojem pomisleku, da to lahko pomeni resno tveganje za javno zdravje.
English: The MAH expressed its disagreement with the CHMP opinion, focusing its scientific grounds on the following points, for which the MAH argues that clear justifications or evidence have not been presented to explain:
Slovenian: Imetnik dovoljenja za promet z zdravilom se ni strinjal z mnenjem CHMP v okviru znanstvenih utemeljitev glede naslednjih dejstev, za katera navaja, da niso bili predstavljeni jasni razlogi ali dokazi:
English: The mutual recognition marketing authorisation application presented for the medicinal product Loraxin 10 mg tablets is a well-established use (WEU) application according to Article 10a of Directive 2001/83/EC.
Slovenian: Vloga za pridobitev dovoljenja za promet s tabletami Loraxin 10 mg na podlagi medsebojnega priznavanja temelji na dejstvu, da je raba zdravila že dobro uveljavljena v skladu s členom 10(a) Direktive 2001/83/ES.
English: In several plasma samples the concentration of loratadine was below the lowest level of quantification (LLOQ).
Slovenian: V več vzorcih plazme koncentracija loratadina ni dosegla spodnje meje določanja.
English: • Pharmacokinetic data
Slovenian: • Farmakokinetični podatki
English: As mentioned previously, Annex I of Directive 2001/83/EC states that the non-clinical and/or clinical overviews must explain the relevance of any data submitted in relation to the product under application.
Slovenian: Kot je bilo že navedeno, je v Prilogi I k Direktivi 2001/83/ES navedeno, da je treba s pregledi neklinične in/ali klinične dokumentacije pojasniti pomembnost vseh podatkov o zdravilu, za katero je bila podana vloga.
English: Norway
Slovenian: Norveško
English: The marketing authorisation for Loraxin and associated names will have to be suspended in the reference Member State, where the product is currently authorised, until such time as adequate data is presented, which will allow a judgment to be made that in spite of the existing formulation differences, Loraxin and the products included in the literature references are considered similar, such that the data generated with these products may be considered relevant to Loraxin, and therefore address the potential serious risk to public health identified by Sweden and Poland.
Slovenian: Dovoljenje za promet z zdravilom Loraxin in povezanimi imeni bo treba začasno umakniti v referenčnih državah članicah, v katerih je promet z zdravilom trenutno dovoljen, dokler ne bodo predloženi ustrezni podatki, ki bodo omogočali presojo, da se zdravilo Loraxin in zdravila, na katera se sklicuje literatura, kljub obstoječim razlikam v farmacevtski obliki štejejo za podobna, tako da je mogoče podatke, ki so bili pridobljeni s temi zdravili, šteti za pomembne za Loraxin, in s tem obravnavati morebitno resno tveganje za javno zdravje, ki je bilo ugotovljeno na Švedskem in Poljskem.
English: Overall, the CHMP was still of the view that due to its limitations, the study could not confirm the relevance of the bibliographic data submitted to demonstrate safety and efficacy of Loraxin.
Slovenian: CHMP je na splošno še vedno menil, da s študijo zaradi njenih omejitev ni bilo mogoče potrditi primernosti bibliografskih podatkov, ki so bili predloženi za dokazovanje varnosti in učinkovitosti Loraxina.
English: The report of a pharmacokinetic study (Report V-808) submitted by the MAH in support of the marketing authorisation application was considered by the CHMP, since the inclusion of pharmacokinetic data in support of a well-established use application could be considered, if it is intended to show the relevance of the literature used to demonstrate safety and efficacy as regards the product concerned.
Slovenian: CHMP je preučil poročilo farmakokinetične študije (poročilo V-808), ki ga je imetnik dovoljenja za promet z zdravilom kot dokazilo priložil vlogi za pridobitev dovoljenja za promet z zdravilom, saj je mogoče upoštevati vključitev farmakokinetičnih podatkov, ki so kot dokazilo priloženi vlogi na podlagi dobro uveljavljene rabe, če se z njimi dokazuje pomembnost uporabljene literature za dokazovanje varnosti in učinkovitosti zadevnega zdravila.
English: Therefore the CHMP was of the view that the submitted pharmacokinetic study report V-808 did not confirm the relevance of the bibliographic data submitted to demonstrate safety and efficacy of Loraxin.
Slovenian: CHMP je tako menil, da predloženo poročilo farmakokinetične študije V-808 ni potrdilo primernosti predloženih bibliografskih podatkov za dokazovanje varnosti in učinkovitosti Loraxina.
English: Based on the pharmacokinetic study results used to bridge Loraxin to the published literature, there is a potential for difference in exposure after Loraxin administration as compared to the product Clarityn, and the MAH has not adequately justified why this potential difference in exposure is unlikely to have a clinically significant difference in efficacy or safety.
Slovenian: Iz rezultatov farmakokinetične študije, ki je bila uporabljena za povezavo zdravila Loraxin z objavljeno literaturo, je razvidno, da lahko nastanejo razlike v izpostavljenosti po aplikaciji zdravila Loraxin v primerjavi z zdravilom Clarityn, imetnik dovoljenja za promet z zdravilom pa ni zadovoljivo utemeljil, zakaj ta morebitna razlika v izpostavljenosti ne bo povzročila klinično pomembne razlike v učinkovitosti ali varnosti.
English: Based on the published literature and the pharmacokinetic study results used to bridge Loraxin to the published literature, the relevance of the literature data submitted which concern a product different from the product intended for marketing was not addressed satisfactorily.
Slovenian: Na podlagi objavljene literature in rezultatov farmakokinetične študije, ki so bili uporabljeni za povezavo zdravila Loraxin z objavljeno literaturo, pomembnost predloženih podatkov iz literature, ki se nanašajo na drugačno zdravilo od tega, ki je namenjeno za promet, ni bila zadovoljivo obravnavana.
English: Therefore the CHMP considered the provided clinical data to be very limited and not strong enough to address what a potential difference in exposure, compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.
Slovenian: CHMP je zaradi tega menil, da so predloženi klinični podatki zelo omejeni in ne kažejo dovolj zanesljivo, kako lahko morebitna razlika med izpostavljenostjo, v primerjavi z izpostavljenostjo po aplikaciji zdravila iz ključnih kliničnih študij, ki so opisane v predloženi bibliografiji, vpliva na učinkovitost in varnost pri vsaki indikaciji.
English: As discussed previously a pharmacokinetic study was provided to bridge Loraxin to the published literature and the AUCt and Cmax of Loraxin to the product Clarityn did not conform to the acceptance interval of 0.8-1.25 for the parent compound, loratadine.
Slovenian: Kot je bilo že navedeno, predložena farmakokinetična študija, ki naj bi povezala Loraxin z objavljeno literaturo, ter AUCt in Cmax, ki naj bi Loraxin povezala z zdravilom Clarityn, niso ustrezali razponu sprejemljivosti 0,81,25 za izhodno sestavino loratadin.
English: In view of the above, the CHMP considered that the pharmaceutical, pharmacokinetic and clinical data/documentation referred to by the MAH was not considered sufficient to establish the relevance of the bibliographic data to Loraxin.
Slovenian: CHMP je glede na navedeno menil, da farmacevtski, farmakokinetični in klinični podatki/dokumentacija, ki jih je navedel imetnik dovoljenja za promet z zdravilom, ne zadoščajo za dokazovanje pomembnosti bibliografskih podatkov za Loraxin.
English: On the basis of the bibliographic data submitted, taken together with the pharmaceutical, pharmacokinetic and clinical documentation, the MAH failed to establish the relevance of these data to demonstrate safety and efficacy of Loraxin.
Slovenian: Na podlagi predloženih bibliografskih podatkov, ob upoštevanju farmacevtske, farmakokinetične in klinične dokumentacije, imetnik dovoljenja za promet z zdravilom ni mogel dokazati pomembnosti teh podatkov za dokazovanje varnosti in učinkovitosti zdravila Loraxin.
English: why the applied loratadine 10 mg product would cause a potential serious risk to public health how the applied loratadine 10 mg product would cause a potential serious risk to public health
Slovenian: zakaj bi aplikacija zdravila, ki vsebuje 10 mg loratadina, lahko resno ogrozila javno zdravje;
English: Finland Vitabalans Oy Varastokatu 8
Slovenian: Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland
English: Furthermore, there were extensive inter-subject variabilities in the absorption parameters of loratadine.
Slovenian: Poleg tega so se pri parametrih absorpcije loratadina pokazala velika nihanja med posameznimi poskusnimi osebami.
English: The Marketing Authorisation Holder is requested to present adequate data, which will allow a judgment to be made that in spite of the existing formulation differences, Loraxin and the products included in the literature references are considered similar, such that the data generated with these products may be considered relevant to Loraxin.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora predložiti ustrezne podatke, ki bodo omogočali presojo, da se Loraxin in zdravila, na katera se sklicuje literatura, kljub obstoječim razlikam v farmacevtski obliki štejejo za podobna, tako da je mogoče podatke, ki so bili pridobljeni s temi zdravili, šteti za pomembne za Loraxin.
English: It is also noted that the case for the safety concerns due to potentially higher exposures has not been adequately addressed by the MAH.
Slovenian: Navedeno je bilo tudi, da imetnik dovoljenja za promet z zdravilom ni ustrezno obravnaval varnostnih pomislekov zaradi morebitne višje izpostavljenosti.
English: • The data referred to by the MAH is not considered sufficient to address what a potential difference in exposure, compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.
Slovenian: • Podatki, na katere se je skliceval imetnik dovoljenja za promet z zdravilom, ne kažejo dovolj zanesljivo, kako lahko morebitna razlika med izpostavljenostjo, v primerjavi z izpostavljenostjo po aplikaciji zdravila iz ključnih kliničnih študij, ki so opisane v predloženi bibliografiji, vpliva na učinkovitost in varnost pri vsaki indikaciji.
English: The MAH's argument that the literature on the originator product is relevant for their product on the basis of the submitted pharmaceutical data is not considered scientifically valid by CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se sklicuje na literaturo o originalnem zdravilu in svoje navedbe podpre s predloženimi farmacevtskimi podatki, vendar ta argument po mnenju CHMP ni znanstveno veljaven.
English: • Pharmaceutical data
Slovenian: • Farmacevtski podatki
English: Therefore, a scientifically valid approach such as the demonstration of comparable kinetics may be necessary to bridge Loraxin to a similar product.
Slovenian: Zaradi tega je za povezavo zdravila Loraxin s podobnim zdravilom morda mogoče treba uporabiti znanstveno veljaven pristop, na primer dokaz o primerljivi kinetiki.
English: In order to show the relevance of the bibliographic data used in support of the application for Loraxin, the MAH referred to pharmaceutical, pharmacokinetic and clinical data.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dokazoval pomembnost bibliografskih podatkov, ki jih je navedel v vlogi za Loraxin, s sklicevanjem na farmacevtske, farmakokinetične in klinične podatke.
English: Denmark
Slovenian: Danski
English: The median age was 64 years.
Slovenian: Mediana starost je bila 64 let.
English: ● if you are pregnant.
Slovenian: ● če ste noseči.
English: It is therefore not authorised to be used in this way.
Slovenian: Zato tudi ni odobreno za tovrstno uporabo.
English: Treatment comparison Other factor
Slovenian: Primerjava zdravljenj Drug dejavnik
English: 25-75 percentile (months)
Slovenian: 25-75 percentilov (meseci)
English: * primary analysis
Slovenian: * primarna analiza
English: The incidence varied between 10% (4/40) and 20% (3/15).
Slovenian: Pojavnost se je gibala med 10 % (4/40) in 20 % (3/15).
English: Both co-primary objectives were met:
Slovenian: Dosegli so oba sočasna primarna cilja:
English: Please consult your doctor, even if these above statements were only applicable to you in the past.
Slovenian: Posvetujte se z zdravnikom, tudi če je zgoraj navedeno za vas veljalo samo v preteklosti.
English: These results have been confirmed through an independent radiological review.
Slovenian: Te rezultate je potrdil tudi neodvisen radiološki pregled.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Slovenian: Če je indicirano, je treba zdravljenje trajno ali začasno prekiniti, kot je opisano v poglavju 4.4.
English: Patients older than 65 years have an increased risk of experiencing the following side effects:
Slovenian: Pri bolnikih, starejših od 65 let, obstaja povečano tveganje za naslednje neželene učinke:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 2019
Slovenian: Datum prve odobritve: 14. februar 2019
English: Discuss with your doctor to make sure that you do not combine these medicine.
Slovenian: Posvetujte se z zdravnikom in se tako prepričajte, da ne boste prejemali kombinacije teh zdravil.
English: It has not been developed or made for injection into the eye.
Slovenian: Niso ga razvili in izdelali za injiciranje v oko.
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Slovenian: Objektivnih (delnih ali popolnih) radioloških odzivov (merila po MacDonaldu) ni bilo.
English: System organ class (SOC)
Slovenian: Organski sistem (SOC - system organ class)
English: Please consult your doctor for more information.
Slovenian: Za več informacij se posvetujte z zdravnikom.
English: These results were consistent with those from various sensitivity analyses and in clinically relevant subgroups.
Slovenian: Ti rezultati so bili skladni z rezultati iz različnih občutljivostnih analiz in rezultati v klinično ustreznih podskupinah.
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (oziroma navesti) v bolnikovo kartoteko.
English: In Part II, treatment assignment was double-blind with respect to bevacizumab.
Slovenian: V 2. delu je bila dodelitev zdravljenja dvojno slepa glede bevacizumaba.
English: Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem (in do 6 mesecev po njem) uporabljati učinkovito kontracepcijo.
English: Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry.
Slovenian: Adjuvantno zdravljenje s taksani so dovolili le, če so ga bolniki zaključili najmanj 12 mesecev pred vstopom v preskušanje.
English: Objective response rate was low in both treatment arms and the difference was not significant.
Slovenian: Objektivni odziv na zdravljenje je bil nizek pri obeh zdravljenih skupinah in razlika ni bila pomembna.
English: • abnormal urine test (protein in the urine),
Slovenian: • nenormalne izvide urinskih preiskav (beljakovine v urinu),
English: ● you may develop a severe migraine.
Slovenian: ● lahko dobite hudo migreno.
English: Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason.
Slovenian: Posvetujte se z zdravnikom, če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje krvi iz kakršnihkoli razlogov.
English: (See section 4.2 for information on paediatric use).
Slovenian: (Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Slovenian: Za dodatne informacije glede statusa receptorja humanega epidermalnega rastnega faktorja 2 (HER2) glejte poglavje 5.1.
English: Please discuss with your doctor if you noticed this previously.
Slovenian: Pogovorite se z zdravnikom, če ste to že kdaj opazili.
English: The adverse reactions listed in this section fall into the following frequency categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: ● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Slovenian: ● To zdravilo poveča tveganje za pojav beljakovin v urinu, zlasti če že imate visok krvni tlak.
English: There were no grade 4 or 5 hypertension events.
Slovenian: Hipertenzije stopnje 4 ali 5 ni bilo.
English: Table 6 Treatment regimens in trial NO16966 (mCRC)
Slovenian: Preglednica 6 Sheme zdravljenja v preskušanju NO16966 (mCRC)
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Slovenian: Hudi neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) vključujejo:
English: Therefore, caution should be exercised before initiating therapy in these patients.
Slovenian: Zato je pred uvedbo zdravljenja pri teh bolnikih potrebna previdnost.
English: Data are unadjusted for the differential time on treatment.
Slovenian: Podatki niso prilagojeni glede na različno trajanje zdravljenja.
English: Name and address of the manufacturer of the biological active substance Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
Slovenian: Ime in naslov izdelovalca biološke učinkovine Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
English: No specific studies in animals have been conducted to evaluate the effect on fertility.
Slovenian: Specifičnih študij na živalih za oceno vpliva na plodnost niso izvedli.
English: *Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Slovenian: *Analiza celokupnega preživetja na podlagi kliničnih podatkov na dan 31. januarja 2007 **Primarna analiza na podlagi kliničnih podatkov na dan 31. januarja 2006 glede na kontrolno skupino
English: intravenous bolus injection immediately after leucovorin
Slovenian: injekcija v bolusu takoj po levkovorinu
English: * if specified, the frequency has been derived from clinical trial data
Slovenian: * kjer je pogostnost navedena, so jo pridobili iz podatkov iz kliničnih preskušanj
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Slovenian: • nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot običajno,
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Slovenian: Izrazi predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem in ne posamezno stanje ali priporočeni izraz po MedDRA (Medical Dictionary for Regulatory Activites - medicinski slovar za regulatorne aktivnosti).
English: ● any severe bleeding.
Slovenian: ● kakršnakoli huda krvavitev.
English: Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Slovenian: Izdelovalec Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Irska
English: Day 1, prior to FOLFOX-4, every 2 weeks
Slovenian: 1. dan, pred shemo FOLFOX-4, vsaka 2 tedna
English: Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Slovenian: Študij za ovrednotenje mutagenega in kancerogenega potenciala bevacizumaba niso izvedli.
English: This does not necessarily mean that these side effects were strictly caused by bevacizumab.
Slovenian: To ne pomeni nujno, da je te neželene učinke povzročil izključno bevacizumab.