FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Slovenian: Morda boste potrebovali nujno zdravniško pomoč:
English: 2.9 m vs 2.8 m p=0.1746
Slovenian: z 2,8 m p = 0,1746
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
Slovenian: Neželeni učinki, ki jih niso opazili v kliničnih študijah, opaženi pa so bili pri kliničnih stopnjah izpostavljenosti v študijah na živalih in bi lahko bili pomembni za klinično uporabo, so: - atrofija roženičnega epitelija in translucence roženice - renalna papilarna nekroza - hepatocelularna nekroza in eozinofilna sinusoidalna infiltracija z makrofagi
English: 3.0 m vs 2.6 m p=0.0006
Slovenian: z 2,6 m p = 0,0006
English: 176 1.1% vs 23.5%
Slovenian: 176 1,1 % v prim.
English: HR 1.16
Slovenian: z 1,6 %
English: Gefitinib is extensively metabolised in humans.
Slovenian: • Zdravilna učinkovina je gefitinib.
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Slovenian: Dehidracija zaradi driske, navzee, bruhanja ali anoreksije Suha usta*, pretežno blaga (1. stopnja po CTC)
English: 5.7 m vs 5.8 m p<0.0001
Slovenian: s 5,8 m p < 0,0001
English: Numbers in square brackets are 96% confidence interval for overall survival
Slovenian: Številke v oglatih oklepajih so 96 % intervali zaupanja za razmerje ogroženosti za skupno preživetje ROG v celotni populaciji, sicer pa 95 % intervali zaupanja za ROG.
English: Weakness
Slovenian: • šibkost
English: Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Red and sore eyelids
Slovenian: • pordele in pekoče veke
English: Trial outcome index results were supportive of FACT-L and LCS results
Slovenian: Trial outcome index rezultati so potrdili rezultate FACT-L in LCS a Prikazane so vrednosti za zdravilo IRESSA v primerjavi s karboplatinom/paklitakselom N Število bolnikov, primernih za analize kakovosti življenja KŽ kakovost življenja
English: 5.6 m vs 2.8 m p<0.0001
Slovenian: z 2,8 m p < 0,0001
English: 9.5 m vs 6.3 m p<0.0001
Slovenian: s 6,3 m p < 0,0001
English: HR NC
Slovenian: PC:
English: Values presented are for IRESSA versus carboplatin/paclitaxel.
Slovenian: • fenitoin ali karbamazepin (za epilepsijo)
English: Measure
Slovenian: Odmerjanje
English: Hair loss
Slovenian: Bolezni nohtov
English: 42.9 v. 20.0 EGFR Mutation+
Slovenian: Pozitivna mutacija EGFR 259 (70,2 % v prim.
English: Adenocarcinoma
Slovenian: Proteinurija
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Slovenian: Ta se lahko pojavi akutno in je bila v nekaterih primerih smrtna (glejte poglavje 4.8).
English: 11.2 m vs 12.7 m
Slovenian: z 12,7 m
English: Bottle (glass)
Slovenian: Steklenička (steklo)
English: 1 bottle +1 adaptor + 3 oral syringes
Slovenian: 1 steklenica + 1 nastavek + 3 brizge za peroralno dajanje
English: MA (EU) number Invented name
Slovenian: (Izmišljeno) ime
English: Oral suspension
Slovenian: Peroralna suspenzija Peroralna uporaba
English: EU/1/04/303/005 Orfadin 4 mg/ml
Slovenian: 4 mg/ml
English: Immediate Packaging Content
Slovenian: Velikost pakiranja
English: Strength Pharmaceutical form Route of administration
Slovenian: Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
English: London, 23 July 2009 Doc.
Slovenian: London, 23. julija 2009 Sklic dok.
English: Ref. EMEA/448660/2009 EMEA/H/C/1041
Slovenian: EMA/123941/2010 EMEA/H/C/1041
English: In 2008, the CHMP had formulated a list of questions to be answered by the company.
Slovenian: Leta 2008 je CHMP pripravil seznam vprašanj, na katera naj bi družba odgovorila.
English: But, the company withdrew its application before responding to the questions.
Slovenian: Vendar je družba umaknila svojo vlogo, še preden je odgovorila na vprašanja.
English: The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Slovenian: Družba je morala predložiti svoje odgovore Odboru za napredne terapije v skladu z novo zakonodajo Evropske unije o naprednih terapijah.
English: Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Slovenian: Poleg tega družba ni predložila dovolj dokazov o tem, da je zdravilo varno, da ga je mogoče izdelati zanesljivo ali da ni škodljivo za okolje ali ljudi, ki so v tesnem stiku z bolnikom.
English: Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Slovenian: Končno je CHMP menil, da ni dovolj informacij o toksičnosti zdravila, njegovi porazdelitvi v telesu in vlogi nekaterih genov in nečistoč v zdravilu.
English: It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Slovenian: Uporabljalo naj bi se pri neodzivnem (ki se ne odziva na zdravljenje) ali ponavljajočem se (ki se ponavlja) raku.
English: This is a type of medicine that works by delivering genes into the body.
Slovenian: To je vrsta zdravila, ki dovaja gene v telo.
English: The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Slovenian: Novi geni povzročijo, da telo začne ali preneha proizvajati beljakovino, ki lahko pomaga pri zdravljenju bolezni.
English: The application was at day 120 of the procedure when the company withdrew.
Slovenian: Družba je vlogo umaknila na 120. dan postopka.
English: Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Slovenian: Zdravilo Contusugene Ladenovec Gendux naj bi se uporabljalo za zdravljenje karcinoma skvamoznih celic glave in vratu (vrste raka, ki se začne v celicah sluznice ustne votline, nosu, žrela ali ušes).
English: Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Contusugene Ladenovec Gendux contusugene ladenovec
English: The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Contusugene Ladenovec Gendux so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Slovenian: Ker rakave celice vsebujejo poškodovano DNK, beljakovina p53 bodisi pomaga popraviti DNK bodisi povzroči odmrtje celic.
English: The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
Slovenian: Beljakovina p53 tudi zmanjša tvorbo krvnih žil, ki oskrbujejo rakave celice.
English: The p53 protein normally contributes to the repair of damaged DNA, causes cell death when the DNA cannot be repaired and helps control the formation of blood vessels.
Slovenian: Beljakovina p53 običajno prispeva k popravilu poškodovane DNK, povzroča odmiranje celic, kjer DNK ni mogoče popraviti, in pomaga nadzorovati tvorbo krvnih žil.
English: The Committee was of the opinion that the company had not shown that Contusugene Ladenovec Gendux was beneficial to patients.
Slovenian: Odbor je menil, da družba ni dokazala, da je zdravilo Contusugene Ladenovec Gendux koristno za bolnike.
English: In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
Slovenian: V eni glavni študiji s 123 bolniki z neodzivnim ali ponavljajočim se karcinomom skvamoznih celic glave in vratu so zdravilo Contusugene Ladenovec Gendux primerjali z metotreksatom (drugo zdravilno učinkovino za zdravljenje raka).
English: On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Slovenian: Družba Gendux Molecular Limited je dne 12. junija 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Contusugene Ladenovec Gendux, namenjenim zdravljenju ponavljajočega se ali neodzivnega karcinoma skvamoznih celic glave in vratu.
English: The virus in Contusugene Ladenovec Gendux is an ‘adenovirus' that has been modified so that it does not cause disease in humans.
Slovenian: Virus v zdravilu Contusugene Ladenovec Gendux je „adenovirus“, ki je bil spremenjen tako, da ne povzroča bolezni pri ljudeh.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Contusugene Ladenovec Gendux?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Contusugene Ladenovec Gendux could not have been approved for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Slovenian: Na podlagi pregleda podatkov je CHMP v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Contusugene Ladenovec Gendux ni mogoče odobriti za zdravljenje ponavljajočega se ali neodzivnega raka skvamoznih celic glave in vratu.
English: Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Contusugene Ladenovec Gendux je bilo razvito kot vrsta zdravila za napredno terapijo, imenovano „zdravilo za genetsko terapijo“.
English: By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
Slovenian: S povečanjem tvorbe beljakovine p53 naj bi zdravilo Contusugene Ladenovec Gendux ozdravilo raka ali upočasnilo njegovo napredovanje.
English: What is Contusugene Ladenovec Gendux?
Slovenian: Kaj je zdravilo Contusugene Ladenovec Gendux?
English: The active substance in Contusugene Ladenovec Gendux, contusugene ladenovec, is a type of virus that has been modified so that it can carry the p53 gene into the cells of the body.
Slovenian: Zdravilna učinkovina zdravila Contusugene Ladenovec Gendux, contusugene ladenovec, je vrsta virusa, ki je bila spremenjena tako, da lahko prenese gen p53 v celice telesa.
English: Contusugene Ladenovec Gendux is a suspension for injection that contains the active substance contusugene ladenovec.
Slovenian: Zdravilo Contusugene Ladenovec Gendux je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino contusugene ladenovec.
English: The Company did not inform the Agency of any patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux.
Slovenian: Družba agencije ni obvestila o morebitnih bolnikih, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Contusugene Ladenovec Gendux.
English: Once injected into the tumour, Contusugene Ladenovec Gendux was expected to carry the p53 gene into the cancer cells, where the gene was expected to make the cell increase the production of the p53 protein.
Slovenian: Po injiciranju v tumor naj bi zdravilo Contusugene Ladenovec Gendux gen p53 preneslo v rakave celice, kjer naj bi povzročil povečano tvorbo beljakovine p53.
English: How is Contusugene Ladenovec Gendux expected to work?
Slovenian: Kako naj bi zdravilo Contusugene Ladenovec Gendux delovalo?
English: What was Contusugene Ladenovec Gendux expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Contusugene Ladenovec Gendux uporabljalo?
English: EU (MA) number Invented name
Slovenian: EU (MA) številka
English: The following new adverse reactions were added during this procedure:
Slovenian: V tem postopku so bili dodani naslednji novi neželeni učinki:
English: Nine additional studies (and one reanalysis of data from the registration studies) have become available.
Slovenian: Na voljo je še devet dodatnih študij (in ena ponovna analiza podatkov iz registracijskih študij).
English: Worldwide, levofloxacin was first approved in 1993 in Japan followed by the United States in 1996.
Slovenian: V svetovnem merilu je bil levofloksacin najprej odobren leta 1993 na Japonskem, nato pa leta 1996 v Združenih državah.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Slovenian: • Odbor je upošteval napotitev v skladu s členom 30 Direktive 2001/83/ES.
English: There are differences between Member States concerning the individual paragraphs in this section.
Slovenian: V posameznih odstavkih tega poglavja obstajajo med državami članicami razlike.
English: However, the role of macrolides has dramatically decreased in many countries due to the increased level of S pneumoniae resistance.
Slovenian: V mnogih državah pa je vloga makrolidov dramatično upadla zaradi povečane ravni odpornosti S pneumoniae.
English: Antibiotic therapy may subsequently be changed in the light of culture results and clinical response.
Slovenian: Zdravljenje z antibiotiki je mogoče naknadno spreminjati glede na rezultate kultur in klinični odziv.
English: Use during pregnancy was agreed to be kept in this section.
Slovenian: Dogovorili so se, da bo uporaba med nosečnostjo še naprej navedena v tem poglavju.
English: These concentrations provide sufficient bactericidal activity on bacterial strains with sensitivity level up to 0.5-1 mg/l.
Slovenian: Te koncentracije zagotavljajo zadostno baktericidno dejavnost na bakterijske seve s stopnjo občutljivosti do 0,5-1 mg/l.
English: There were three pivotal studies supporting this indication.
Slovenian: Izvedene so bile tri ključne študije, ki so podprle to indikacijo.
English: Thus, the outcome of this referral procedure does not include any evaluation of levofloxacin 750 mg.
Slovenian: Zato izid tega napotitvenega postopka ne vključuje nobene ocene levofloksacina v odmerku 750 mg.
English: Patients with CAP who are moderately to severely ill, are usually hospitalized.
Slovenian: Bolniki z ZBP, ki so zmerno do hudo bolni, so običajno hospitalizirani.
English: Overall summary of the scientific evaluation of Tavanic and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Tavanic in povezanih imen (glejte Prilogo I)
English: Furthermore, the wording is misleading as it implies that standard treatment is monotherapy.
Slovenian: Poleg tega je besedilo zavajajoče, saj nakazuje, da je standardno zdravljenje monoterapija.
English: The EUCAST information was aligned with the current EUCAST recommendations.
Slovenian: Informacije odbora EUCAST so bile usklajene z njegovimi trenutnimi priporočili.
English: The main differences in this section accepted by the CHMP are listed below.
Slovenian: Glavne razlike v tem poglavju, ki jih je sprejel odbor CHMP, so naštete spodaj.
English: A general consideration to be taken into account is that ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Slovenian: Treba je upoštevati splošno ugotovitev, da ABS običajno ni huda okužba in da je povezan z visokimi ravnmi spontane ozdravitve (90 %).
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Treba je upoštevati uradne smernice za ustrezno uporabo protibakterijskih sredstev.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Slovenian: Na podlagi pregleda podatkov je odbor CHMP sprejel usklajeni modul 3.
English: Section 4.6 - Fertility, Pregnancy and Lactation
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje
English: The proposed harmonised indication wording was considered to better reflect the current overall European treatment recommendations.
Slovenian: Za predlagano usklajeno besedilo o indikaciji se meni, da bolje izraža trenutna splošna evropska priporočila za zdravljenje.
English: This is adequate for most infective diseases (respiratory and skin) listed in the levofloxacin indications.
Slovenian: To zadošča za večino infekcijskih bolezni (dihal in kože), ki so naštete med indikacijami za levofloksacin.
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Slovenian: Metoda in statistični pristop sta bila pregledana skupaj s predloženimi podatki, odbor CHMP pa je presodil, da je ocenjena pogostnost ustrezna.
English: Antibiotic therapy is indicated and usually starts empirically, covering typical organisms with or without atypical organisms.
Slovenian: Zdravljenje z antibiotiki je indicirano in se običajno začne empirično, tako da pokriva tipične organizme z atipičnimi organizmi ali brez njih.
English: It was further agreed that consideration should be given to the European guidelines whereby quinolones are only recommended as first line therapy if the resistance rate for E. coli (responsible for 70-80% of all UTIs caused by Gram-negative) is below 10%.
Slovenian: Nadalje je bilo sklenjeno, da je treba upoštevati evropske smernice, v katerih so kinoloni priporočeni kot zdravljenje prve izbire samo, če je stopnja odpornosti E. coli (ki je odgovorna za 70-80 % vseh okužb sečil, ki jih povzročijo po Gramu negativni organizmi) nižja od 10 %.
English: The studies above mentioned do not permit to overcome this issue as no placebocontrolled studies were performed.
Slovenian: Zgoraj navedene študije te težave niso odpravile, saj ni bila izvedena nobena študija, ki bi bila nadzorovana s placebom.
English: In conclusion, the CHMP adopted a harmonised wording for section 5.1
Slovenian: Če povzamemo, je odbor CHMP sprejel usklajeno besedilo poglavja 5.1.
English: Namely, the inclusion of bacteroides sp. other than B. fragilis was removed due to the natural intermediate susceptibility to levofloxacin.
Slovenian: Tako je bila vključitev bacteroides sp. razen B. fragilis odstranjena zaradi naravne srednje občutljivosti za levofloksacin.
English: • Hypoglycaemic coma, in line with the CCSI version 4 for levofloxacin submitted as part of the PSUR 27;
Slovenian: • hipoglikemična koma, v skladu z različico CCSI 4 za levofloksacin, ki je bila oddana kot del poročila PSUR 27;
English: The general text of frequencies classification, and the adverse reaction obtained from post-marketing experience were clarified, and the frequency of a number of events was revised.
Slovenian: Splošno besedilo o razvrščanju pogostnosti in neželene reakcije, pridobljene iz izkušenj v času trženja zdravila, so bile razjasnjeni, pogostnost števila dogodkov pa revidirana.
English: Information on development, manufacture and control of the film coated tablets and solution for infusion has been presented in a satisfactory manner.
Slovenian: Informacije o razvoju, izdelavi in nadzoru filmsko obloženih tablet in raztopine za infundiranje so bile zadovoljivo predstavljene.
English: A warning on the need to have an adequate diagnosis of ABS and AECB before the use of levofloxacin is added.
Slovenian: Dodano je bilo opozorilo o potrebi po ustrezni diagnozi ABS in AEKB pred uporabo levofloksacina.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised PIs and thus to harmonise its divergent PIs across the European Union.
Slovenian: Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila (in povezanih imen), je Evropska komisija obvestila Sekretariat CHMP/EMA o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi razrešil razhajanja med nacionalno odobrenimi informacijami o zdravilu in uskladil razhajajoče se informacije po vsej Evropski uniji.
English: • Ligament rupture, in line with a review provide by the MAH in which possible causal relationship in some cases without alternative explanations in combination with biological plausibility were identified.
Slovenian: • pretrganje vezi, v skladu s pregledom, ki ga je posredoval imetnik dovoljenja za promet z zdravilom, in v katerem je bilo v nekaterih primerih identificirano morebitno vzročno razmerje brez alternativnih razlag v kombinaciji z biološko verjetnostjo.
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Slovenian: Rezultati izvedenih testov nakazujejo zadovoljivo doslednost in enotnost pomembnih značilnosti kakovosti zdravila, na podlagi česar je mogoče zaključiti, da bi zdravila morala izkazati zadovoljivo in enotno delovanje v kliničnem okolju.
English: No other discrepancies in this section were detected in regard to special populations: impaired renal function and/or elderly.
Slovenian: V tem poglavju niso bila odkrita druga odstopanja glede posebnih skupin bolnikov: okvarjena ledvična funkcija in/ali starejši.
English: In this regard a recent published epidemiologic study revealed an increased risk (OR 4.5) of fluoroquinolones for retinal detachment.
Slovenian: V zvezi s tem je nedavno objavljena epidemiološka študija odkrila povečano tveganje za odstop mrežnice (OR 4.5) pri uporabi fluorokinolonov.
English: The warning on prevention of photosensitisation was revised to further recommend precaution during treatment and 48 hours following treatment discontinuation.
Slovenian: Opozorilo o preprečevanju preobčutljivosti za svetlobo je bilo revidirano tako, da še naprej priporoča previdnost med zdravljenjem in 48 ur po zaključku zdravljenja.
English: In addition, the information on the combination treatment that may be required in case of nosocomial infections due to P. aeruginosa was deleted since it is considered not appropriate to be included in this section.
Slovenian: Poleg tega so bili izbrisane informacije o kombiniranem zdravljenju, ki je lahko potrebno v primeru nozokomialnih okužb s P. aeruginosa, saj naj vključitev v to poglavje ne bi bila ustrezna.
English: This review showed possible association within the fluoroquinolon class specifically the use of levofloxacin and exacerbation of myasthenia gravis although the reporting rate for this event remains extremely low.
Slovenian: Ta pregled je pokazal morebitno povezavo v okviru razreda fluorokinolonov, zlasti med uporabo levofloksacina in poslabšanjem miastenije gravis, čeprav stopnja poročanja o tem dogodku ostaja izjemno nizka.
English: The SPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Slovenian: Pri uskladitvi povzetka glavnih značilnosti zdravila so bile upoštevane vse ustrezne terapevtske in regulatorne smernice v EU.
English: The major objections preventing the granting of this indication in one MS was the X-ray criteria for the corroboration of the clinical diagnosis of sinusitis which was not defined clearly in one of the studies.
Slovenian: Glavne ovire, ki so preprečile odobritev te indikacije v eni državi članici, so bila rentgenska merila za potrditev klinične diagnoze sinusitisa, ki v eni od študij niso bili jasno opredeljeni.