natgillin/translations-raw huggingface dataset:
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.
Zdravilna učinkovina zdravila Contusugene Ladenovec Gendux, contusugene ladenovec, je vrsta virusa, ki je bila spremenjena tako, da lahko prenese gen p53 v celice telesa.
Contusugene Ladenovec Gendux is a suspension for injection that contains the active substance contusugene ladenovec.
Zdravilo Contusugene Ladenovec Gendux je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino contusugene ladenovec.
The Company did not inform the Agency of any patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux.
Družba agencije ni obvestila o morebitnih bolnikih, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Contusugene Ladenovec Gendux.
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.
Po injiciranju v tumor naj bi zdravilo Contusugene Ladenovec Gendux gen p53 preneslo v rakave celice, kjer naj bi povzročil povečano tvorbo beljakovine p53.
How is Contusugene Ladenovec Gendux expected to work?
Kako naj bi zdravilo Contusugene Ladenovec Gendux delovalo?
What was Contusugene Ladenovec Gendux expected to be used for?
Za kaj naj bi se zdravilo Contusugene Ladenovec Gendux uporabljalo?
EU (MA) number Invented name
EU (MA) številka
The following new adverse reactions were added during this procedure:
V tem postopku so bili dodani naslednji novi neželeni učinki:
Nine additional studies (and one reanalysis of data from the registration studies) have become available.
Na voljo je še devet dodatnih študij (in ena ponovna analiza podatkov iz registracijskih študij).
Worldwide, levofloxacin was first approved in 1993 in Japan followed by the United States in 1996.
V svetovnem merilu je bil levofloksacin najprej odobren leta 1993 na Japonskem, nato pa leta 1996 v Združenih državah.
• The committee considered the referral under Article 30 of Directive 2001/83/EC
• Odbor je upošteval napotitev v skladu s členom 30 Direktive 2001/83/ES.
There are differences between Member States concerning the individual paragraphs in this section.
V posameznih odstavkih tega poglavja obstajajo med državami članicami razlike.
However, the role of macrolides has dramatically decreased in many countries due to the increased level of S pneumoniae resistance.
V mnogih državah pa je vloga makrolidov dramatično upadla zaradi povečane ravni odpornosti S pneumoniae.
Antibiotic therapy may subsequently be changed in the light of culture results and clinical response.
Zdravljenje z antibiotiki je mogoče naknadno spreminjati glede na rezultate kultur in klinični odziv.
Use during pregnancy was agreed to be kept in this section.
Dogovorili so se, da bo uporaba med nosečnostjo še naprej navedena v tem poglavju.
These concentrations provide sufficient bactericidal activity on bacterial strains with sensitivity level up to 0.5-1 mg/l.
Te koncentracije zagotavljajo zadostno baktericidno dejavnost na bakterijske seve s stopnjo občutljivosti do 0,5-1 mg/l.
There were three pivotal studies supporting this indication.
Izvedene so bile tri ključne študije, ki so podprle to indikacijo.
Thus, the outcome of this referral procedure does not include any evaluation of levofloxacin 750 mg.
Zato izid tega napotitvenega postopka ne vključuje nobene ocene levofloksacina v odmerku 750 mg.
Patients with CAP who are moderately to severely ill, are usually hospitalized.
Bolniki z ZBP, ki so zmerno do hudo bolni, so običajno hospitalizirani.
Overall summary of the scientific evaluation of Tavanic and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Tavanic in povezanih imen (glejte Prilogo I)
Furthermore, the wording is misleading as it implies that standard treatment is monotherapy.
Poleg tega je besedilo zavajajoče, saj nakazuje, da je standardno zdravljenje monoterapija.
The EUCAST information was aligned with the current EUCAST recommendations.
Informacije odbora EUCAST so bile usklajene z njegovimi trenutnimi priporočili.
The main differences in this section accepted by the CHMP are listed below.
Glavne razlike v tem poglavju, ki jih je sprejel odbor CHMP, so naštete spodaj.
A general consideration to be taken into account is that ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Treba je upoštevati splošno ugotovitev, da ABS običajno ni huda okužba in da je povezan z visokimi ravnmi spontane ozdravitve (90 %).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Treba je upoštevati uradne smernice za ustrezno uporabo protibakterijskih sredstev.
Based on the review of data the CHMP adopted a harmonised Module 3.
Na podlagi pregleda podatkov je odbor CHMP sprejel usklajeni modul 3.
Section 4.6 - Fertility, Pregnancy and Lactation
Poglavje 4.6 - Plodnost, nosečnost in dojenje
The proposed harmonised indication wording was considered to better reflect the current overall European treatment recommendations.
Za predlagano usklajeno besedilo o indikaciji se meni, da bolje izraža trenutna splošna evropska priporočila za zdravljenje.
This is adequate for most infective diseases (respiratory and skin) listed in the levofloxacin indications.
To zadošča za večino infekcijskih bolezni (dihal in kože), ki so naštete med indikacijami za levofloksacin.
The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Metoda in statistični pristop sta bila pregledana skupaj s predloženimi podatki, odbor CHMP pa je presodil, da je ocenjena pogostnost ustrezna.
Antibiotic therapy is indicated and usually starts empirically, covering typical organisms with or without atypical organisms.
Zdravljenje z antibiotiki je indicirano in se običajno začne empirično, tako da pokriva tipične organizme z atipičnimi organizmi ali brez njih.
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%.
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 %.
The studies above mentioned do not permit to overcome this issue as no placebocontrolled studies were performed.
Zgoraj navedene študije te težave niso odpravile, saj ni bila izvedena nobena študija, ki bi bila nadzorovana s placebom.
In conclusion, the CHMP adopted a harmonised wording for section 5.1
Če povzamemo, je odbor CHMP sprejel usklajeno besedilo poglavja 5.1.
Namely, the inclusion of bacteroides sp. other than B. fragilis was removed due to the natural intermediate susceptibility to levofloxacin.
Tako je bila vključitev bacteroides sp. razen B. fragilis odstranjena zaradi naravne srednje občutljivosti za levofloksacin.
• Hypoglycaemic coma, in line with the CCSI version 4 for levofloxacin submitted as part of the PSUR 27;
• hipoglikemična koma, v skladu z različico CCSI 4 za levofloksacin, ki je bila oddana kot del poročila PSUR 27;
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.
Splošno besedilo o razvrščanju pogostnosti in neželene reakcije, pridobljene iz izkušenj v času trženja zdravila, so bile razjasnjeni, pogostnost števila dogodkov pa revidirana.
Information on development, manufacture and control of the film coated tablets and solution for infusion has been presented in a satisfactory manner.
Informacije o razvoju, izdelavi in nadzoru filmsko obloženih tablet in raztopine za infundiranje so bile zadovoljivo predstavljene.
A warning on the need to have an adequate diagnosis of ABS and AECB before the use of levofloxacin is added.
Dodano je bilo opozorilo o potrebi po ustrezni diagnozi ABS in AEKB pred uporabo levofloksacina.
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.
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.
• 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.
• 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.
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.
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.
No other discrepancies in this section were detected in regard to special populations: impaired renal function and/or elderly.
V tem poglavju niso bila odkrita druga odstopanja glede posebnih skupin bolnikov: okvarjena ledvična funkcija in/ali starejši.
In this regard a recent published epidemiologic study revealed an increased risk (OR 4.5) of fluoroquinolones for retinal detachment.
V zvezi s tem je nedavno objavljena epidemiološka študija odkrila povečano tveganje za odstop mrežnice (OR 4.5) pri uporabi fluorokinolonov.
The warning on prevention of photosensitisation was revised to further recommend precaution during treatment and 48 hours following treatment discontinuation.
Opozorilo o preprečevanju preobčutljivosti za svetlobo je bilo revidirano tako, da še naprej priporoča previdnost med zdravljenjem in 48 ur po zaključku zdravljenja.
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.
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.
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.
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.
The SPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Pri uskladitvi povzetka glavnih značilnosti zdravila so bile upoštevane vse ustrezne terapevtske in regulatorne smernice v EU.
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.
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.
In particular, the indications and their associated posology recommendations were harmonised.
Usklajene so bile zlasti indikacije in z njimi povezana priporočila o odmerjanju.
The gold standard for these pathogens remains penicillin (with the exception of MRSA - Methicillin-resistant staphylococcus aureus).
Zlati standard za te patogene ostaja penicilin (razen okužb z MRSA - proti meticilinu odpornimi Staphylococcus aureus).
The pivotal study was CAPSS-101, a large registration study that showed levofloxacin to be equivalent to ciprofloxacin in well-documented chronic bacterial prostatitis, and these data have ever since been supplemented by two published studies.
Ključna študija je bila CAPSS-101, obsežna registracijska študija, ki je dokazala, da je levofloksacin enakovreden ciprofloksacinu pri dobro dokumentiranem kroničnem bakterijskem prostatitisu, ti podatki pa so bili od tedaj dopolnjeni še z dvema objavljenima študijama.
Acute bacterial sinusitis (ABS)
Akutni bakterijski sinusitis (ABS)
This indication has been approved in all MS based on four pivotal studies.
Ta indikacija je bila odobrena v vseh državah članicah na podlagi štirih ključnih študij.
Since the granting of this indication in the EU, twenty two additional studies have become available including 4 recent trials of levofloxacin used as a comparator versus tigecycline (2 studies), docycycline (one study) and nemonoxacin (one study).
Od odobritve te indikacije v EU je na voljo že dvaindvajset dodatnih študij, vključno s štirimi nedavnimi preskušanji levofloksacina, uporabljenega kot primerjalno zdravilo za primerjavo s tigeciklinom (dve študiji), dociciklinom (ena študija) in nemonoksacinom (ena študija).
In this case, “alternative” is defined as: to be used in case of hypersensitivity to a preferred drug or widespread prevalence of clinically relevant resistance in the population being treated.
V tem primeru je „alternativni“ definiran kot: za uporabo v primeru preobčutljivosti za izbrano zdravilo ali velike razširjenosti klinično pomembne odpornosti v zdravljeni populaciji.
Monitoring cases of haemolytic anaemia in these patients is recommended.
Pri teh bolnikih je priporočeno spremljanje hemolitične anemije.
The proposed harmonised warning on G-6-PD deficiency was supported by a review provided by the MAH on all G6PD cases and no new safety information was found.
Predlagano usklajeno opozorilo glede pomanjkanja G-6-PD je podprl pregled, ki ga je izvedel imetnik dovoljenja za promet za vse primere G6PD, v okviru katerega niso bile ugotovljene nobene nove informacije o varnosti.
• “Palpitation” and “ventricular tachycardia which may result in cardiac arrest” supported by data from clinical trials and post-marketing data provided by the MAH;
• „palpitacije“ in „ventrikularna tahikardija, ki ji lahko sledi srčni zastoj“, ki so podprte s podatki iz kliničnih preskušanj in podatki iz časa trženja zdravila, ki jih je predložil imetnik dovoljenja za promet z zdravilom;
This section was further amended to clearly mention that treatment with levofloxacin is contraindicated during breastfeeding and to include information on fertility also in line with the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling, January 2009.
To poglavje je bilo nadalje spremenjeno tako, da jasno navaja, da je zdravljenje z levofloksacinom kontraindicirano v času dojenja, in da vključuje informacije o plodnosti v skladu s Smernicami o oceni tveganja zdravil za razmnoževanje in laktacijo pri človeku odbora CHMP: od podatkov do označevanja, januar 2009.
Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Zdravilo Tavanic je mogoče uporabljati tudi za zaključek terapije pri bolnikih, pri katerih je prišlo do izboljšanja v času začetnega zdravljenja z intravenskim levofloksacinom.
The warning on tendinitis and tendon rupture was amended to state that the risk of tendinitis and tendon rupture is increased in patients receiving daily doses of 1000 mg.
Opozorilo o tenditisu in pretrganju kit je bilo spremenjeno tako, da navaja, da je tveganje za tenditis in pretrganje kit povečano pri bolnikih, ki prejemajo dnevne odmerke 1 000 mg.
The harmonised warning on QT interval prolongation was amended in line with the updated recommendation from the CHMP' pharmacovigilance working party dated 16 April 2012 with regards fluoroquinolones and risk of QT-interval prolongation.
Usklajeno opozorilo o podaljšanju intervala QT je bilo spremenjeno v skladu s posodobljenim priporočilom Delovne skupine za farmakovigilanco odbora CHMP z dne 16. aprila 2012, ki se nanaša na fluorokinolone in tveganje za podaljšanje intervala QT.
As mentioned above, resistance of E.coli to fluoroquinolon and the need for prescribers to consider local prevalence resistance was included in this section.
Kot je navedeno zgoraj, sta bili v to poglavje vključeni odpornost E.coli proti fluorokinolonu in potreba, da zdravniki, ki predpisujejo zdravilo, upoštevajo lokalno prevalenco odpornosti.
The discrepancies in this section regarded the use during pregnancy and in patients with glucose-6phosphate dehydrogenase (G6PD) deficiency (divergence in one MS).
Odstopanja v tem poglavju so se nanašala na uporabo pri nosečnicah in bolnikih s pomanjkanjem glukoza-6-fosfat-dehidrogenaze (G6PD) (razhajanje v eni državi članici).
The Cmax/MIC ration of 10 and an AUC/MIC ratio of 100 are recommended in the literature to represent a rapid bactericidal activity.
Razmerje Cmaks./MIK 10 in razmerje AUC/MIK 100 sta v literaturi priporočeni kot hitra baktericidna dejavnost.
This proposal for a restricted indication is in line with the current EU treatment guidelines to not overall recommend fluoroquinolones as first line treatment option.
Predlog za omejeno indikacijo je v skladu s trenutnimi smernicami za zdravljenje v EU, ki v splošnem fluorokinolonov ne priporočajo kot zdravljenja prve izbire.
This amendment is based on a newly submitted analysis showing that elderly are more vulnerable for tendon injury if received daily 1000 mg compared to 750 mg, epidemiologic studies, additional risk in renal impaired patients without dose adjustment and taking into account the biological plausibility of dose dependent cytotoxicity of fluoroquinolones these findings suggests that dosages of 1000 mg per day are an additional risk factor for tendon injuries.
Ta sprememba temelji na nedavno predloženi analizi, ki dokazuje, da so starejši bolniki bolj nagnjeni k poškodbam kit, če prejemajo dnevno 1 000 mg, v primerjavi s 750 mg, epidemioloških študijah in dodatnem tveganju za bolnike z okvarami jeter brez prilagoditve odmerka, ob upoštevanju biološke verjetnosti za od odmerka odvisno citotoksičnost fluorokinolonov pa ta odkritja nakazujejo, da so dnevni odmerki 1 000 mg dodaten dejavnik tveganja za poškodbe kit.
Fluoroquinolones are particularly useful in severe cases due to their coverage of Gram-negative organisms as well as the more common H. influenzae and S. pneumoniae.
Fluorokinoloni so še posebno uporabni v hudih primerih, saj pokrivajo po Gramu negativne organizme ter pogostejše organizme H. influenzae in S. pneumoniae.
Since Anthrax is life-threatening, especially when the route of infection is inhalation it was agreed the following harmonised wording for:
Ker je vranični prisad življenjsko nevaren, zlasti če se okužba širi z vdihavanjem, so se dogovorili za naslednje usklajeno besedilo za:
In particular, the table of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints and the table of susceptible species were revised.
Še zlasti so bile revidirane spremembe mejnih vrednosti Evropskega odbora za testiranje občutljivosti na antibiotike (EUCAST) in preglednice dovzetnih vrst.
The warning on pneumococcal pneumonia was deleted since it was considered covered by the information included in section 4.1 that levofloxacin should only be considered as alternative treatment in such cases.
Opozorilo o pnevmokokni pljučnici je bilo izbrisano, saj naj bi bilo zajeto že v informacijah, vključenih v poglavje 4.1, da je treba levofloksacin v takih primerih upoštevati samo kot alternativno zdravljenje.
Although levofloxacin is not considered the drug of choice for the treatment of AECB, it is recommended as one of the possible alternatives for the treatment in the case of frequent exacerbations and in the case of severe chronic obstructive pulmonary disease (COPD).
Čeprav levofloksacin ni izbrano zdravilo za zdravljenje AEKB, je priporočeno kot ena izmed možnih alternativ za zdravljenje v primeru pogostih poslabšanj in v primeru hude kronične obstruktivne pljučne bolezni (KOPB).
Tavanic, solution for infusion, 5 mg/ml
Tavanic, raztopina za infundiranje, 5 mg/ml
The MAH submitted a proposal for harmonisation of the Quality module.
Imetnik dovoljenja za promet z zdravilom je predložil predlog za uskladitev modula o kakovosti.
This indication was not approved in one MS, due to the fact that the pivotal studies (five studies) did not use a conventional comparator also considering that, for uncomplicated SSTI the use of fluoroquinolones is not considered appropriate and for complicated SSTI the results were not clearly favouring levofloxacin.
Indikacija ni bila odobrena v eni državi članici, ker ključne študije (pet študij) niso vključile običajnega primerjalnega zdravila, ter ob upoštevanju, da se za nezapletene OKMT uporaba fluorokinolonov ne zdi ustrezna, za zapletene OKMT pa izidi niso prikazali jasne prednosti levofloksacina.
However, most MRSA isolates are resistant to levofloxacin.
Kljub temu pa je večina izolatov MRSA odpornih na levofloksacin.
Levofloxacin has been studied in large AECB controlled trials with an active comparator but no placebo-controlled study has been conducted.
Levofloksacin je bil proučevan v obsežnih nadzorovanih preskušanjih AEKB z aktivnim primerjalnim zdravilom, izvedena pa ni bila nobena študija, nadzorovana s placebom.
The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggested appropriate changes in the text where divergences exist and in some cases summarised the information already included in these sections (e.g. in section 5.2 of the SmPC information on tissue distribution was summarised).
Imetnik dovoljenja za promet, ki je bil naprošen za oceno vseh drugih poglavij nacionalno odobrenih povzetkov glavnih značilnosti zdravila, je predlagal ustrezne spremembe v besedilu, v katerem obstajajo razhajanja, in v nekaterih primerih povzel informacije, ki so že vključene v teh poglavjih (npr. v poglavju 5.2 povzetka glavnih značilnosti zdravila je povzel informacije o razporeditvi v tkiva).
The pivotal study was study LOFBO-UTI-060: A multicenter, double-blind, randomized study to compare the safety and efficacy of oral levofloxacin with that of Floxin (ofloxacin) in the treatment of uncomplicated urinary tract infections in women.
Ključna študija je bila študija LOFBO-UTI-060: multicentrična, dvojno slepa, randomizirana študija, v kateri so primerjali varnost in učinkovitost peroralnega levofloksacina z varnostjo in učinkovitostjo zdravila Floxin (ofloksacin) pri zdravljenju nezapletenih okužb sečil pri ženskah.
In addition, it was agreed to include precautions for use in case of treatment of anthrax in section 4.4 to include reference for consultation of national and/or international consensus documents.
Poleg tega so se dogovorili za vključitev previdnostnih ukrepov v primeru zdravljenja vraničnega prisada v poglavje 4.4, ki tako vključuje sklic za upoštevanje veljavnih nacionalnih in/ali mednarodnih dokumentov o soglasju glede zdravljenja vraničnega prisada.