FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Kanjinti has been shown overall to have a comparable quality, safety and effectiveness to Herceptin.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Kanjinti po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Herceptin.
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Slovenian: Pri zgodnjem raku dojk zdravljenje poteka eno leto ali dokler se bolezen ne ponovi, pri metastatskem raku dojk in raku želodca pa traja, dokler je učinkovito.
English: The reference medicine for Kanjinti is Herceptin.
Slovenian: Referenčno zdravilo za zdravilo Kanjinti je zdravilo Herceptin.
English: Because Kanjinti is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Kanjinti.
Slovenian: Zdravilo Kanjinti je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Kanjinti ni treba ponavljati.
English: The active substance in Kanjinti, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Slovenian: Učinkovina v zdravilu Kanjinti, trastuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino HER2 in se veže nanjo.
English: Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin.
Slovenian: Študije so pokazale tudi, da zdravilo Kanjinti vzpostavi podobne ravni učinkovine v telesu kot zdravilo Herceptin.
English: Kanjinti is a ‘biosimilar medicine'.
Slovenian: Zdravilo Kanjinti je „podobno biološko zdravilo“.
English: Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Kanjinti primerjali z zdravilom Herceptin, so pokazale, da je učinkovina zdravila Kanjinti po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Herceptin.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Kanjinti outweighs the identified risk and it can be authorised.
Slovenian: Menila je, da koristi zdravila Kanjinti enako kot pri zdravilu Herceptin odtehtajo znana tveganja in se zdravilo lahko odobri.
English: How does Kanjinti work?
Slovenian: Kako zdravilo Kanjinti deluje?
English: How is Kanjinti used?
Slovenian: Kako se zdravilo Kanjinti uporablja?
English: Kanjinti contains the active substance trastuzumab.
Slovenian: Zdravilo Kanjinti vsebuje učinkovino trastuzumab.
English: Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Slovenian: Zdravilo Kanjinti se uporablja le, kadar rakavo tkivo dokazano čezmerno izraža receptorje HER2.
English: • Problems with balance or coordination
Slovenian: • težave z ravnotežjem ali koordinacijo
English: Compatibility with other concentrations is unknown.
Slovenian: Združljivost z drugimi koncentracijami ni znana.
English: These precautions are also applicable to children.
Slovenian: Ti previdnostni ukrepi veljajo tudi za otroke.
English: >R (Resistant)
Slovenian: >R (odporni)
English: Total parenteral nutrition:
Slovenian: Popolna parenteralna prehrana:
English: Frequency not known (cannot be estimated from available data)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivi h podatkov)
English: However, some may be serious and need medical attention.
Slovenian: Po drugi strani pa so nekateri lahko resni in zahtevajo zdravniško nego.
English: Not studied clinically.
Slovenian: Niso klinično preučili.
English: Therefore, every attempt should be made to identify Candida to species level.
Slovenian: Zato je treba storiti vse za to, da bi identificirali Candido do ravni vrste.
English: Treatment duration should be as short as possible depending on the patient's clinical and mycological response.
Slovenian: Trajanje zdravljenja mora biti čim krajše, odvisno od bolnikovega kliničnega in mikološkega odziva.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015}
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: {27. maj 2015}
English: Clinical Experience Successful outcome in this section is defined as complete or partial response.
Slovenian: Klinične izkušnje Uspešen izid je v tem delu opredeljen kot popoln ali delen odziv.
English: • You have had an allergic reaction to other azoles.
Slovenian: • ste kdaj doživeli alergijsko reakcijo na druge azole.
English: The asterisk (*) indicates a two-way interaction.
Slovenian: Zvezdica (*) označuje dvosmerno interakcijo.
English: In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Slovenian: Poleg tega so uspešen odziv ugotovili pri 1 od 3 bolnikov z okužbami, ki jih je povzročil več kot en organizem, vključno s Scedosporium spp.
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8 in 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: Difference in proportions and the 95% confidence interval (CI)
Slovenian: Razlike v deležih in 95 % interval zaupanja (IZ)
English: The clinical efficacy data were supported by limited susceptibility data.
Slovenian: Podatke o klinični učinkovitosti so podprli omejeni podatki o občutljivosti.
English: pH of the reconstituted solution is 4.0 to 7.0.
Slovenian: pH rekonstituirane raztopine je 4,0 do 7,0.
English: The recommended dose for adults (including elderly patients) is as follows:
Slovenian: Priporočeni odmerek za odrasle (vključno s starejšimi bolniki) je:
English: parapsilosis and C. tropicalis.
Slovenian: parapsilosis in C. tropicalis.
English: In this analysis a successful response was seen in 41 % of patients in both treatment arms.
Slovenian: V tej analizi so uspešen odziv ugotovili pri 41 % bolnikov v obeh terapevtskih krakih.
English: Osmolality: 500± 50 mOsm/kg
Slovenian: Osmolalnost: 500± 50 mOsm/kg
English: Four additional patients with fusariosis had an infection caused by several organisms; two of them had a successful outcome.
Slovenian: Dodatni štirje bolniki s fuzaridiozo so imeli okužbo, povzročeno z več organizmi; 2 od njih sta doživela uspešen izid.
English: The Investigator's assessment of successful outcome at each of these time points is shown in the following table.
Slovenian: Raziskovalčevo oceno uspešnega izida na vsaki od teh časovnih točk prikazuje naslednja preglednica.
English: Successful response was seen in 24 patients (15 complete, 9 partial responses).
Slovenian: Uspešen odziv so ugotovili pri 24 bolnikih (15 popolnih, 9 delnih odzivov).
English: The following instructions apply to both Treatment and Prophylaxis.
Slovenian: Naslednja navodila veljajo tako za zdravljenje kot tudi za profilakso
English: This impurity should be considered a substance with carcinogenic potential in humans.
Slovenian: To nečistočo je treba obravnavati kot snov s karcinogenim potencialom za ljudi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Frequency categories are expressed as: 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: Pogostnosti neželenih učinkov so opredeljene kot sledi: 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: Please refer to the treatment tables above.
Slovenian: Glejte preglednice zdravljenja zgoraj.
English: These results are relevant to other populations and routes of administration.
Slovenian: Ti izsledki se nanašajo tudi na druge populacije in načine uporabe.
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Slovenian: Ker pa je bilo na voljo le 9 primerov za EUCAST analizo, je zaenkrat premalo dokazov za postavitev kliničnih mejnih vrednosti za C. krusei.
English: The mechanism of action is unknown, although the site of action is most likely to be within the retina.
Slovenian: Mehanizem tega delovanja ni znan, mesto delovanja pa je najverjetneje v mrežnici.
English: The recommended dose for children and teenagers is as follows:
Slovenian: Priporočeni odmerek za otroke in mladostnike je sledeč:
English: Plasma protein binding is estimated to be 58 %.
Slovenian: Ocenjena vezava na beljakovine v plazmi je 58 %.
English: It may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia.
Slovenian: Lahko povzroči prehodne in reverzibilne spremembe vida, vključno z zamegljenim vidom, spremenjenim/okrepljenim vidnim zaznavanjem in/ali fotofobijo.
English: Patients who did not have an assessment 12 weeks after EOT were counted as failures.
Slovenian: Bolniki, ki niso imeli opravljene ocene 12 tednov po koncu terapije, so bili obravnavani kot neuspeh.
English: • Decreased sensitivity to touch
Slovenian: • zmanjšana občutljivost na dotik
English: However, tell your doctor or pharmacist if you think that a dose has been forgotten.
Slovenian: Vendar zdravniku ali farmacevtu vseeno povejte, če se vam zdi, da je bil odmerek pozabljen.
English: Prophylaxis should be initiated on the day of transplant and may be administered for up to 100 days.
Slovenian: Profilakso je treba začeti na dan transplantacije, uporablja pa se lahko največ 100 dni.
English: While affected, do not drive or operate any tools or machines.
Slovenian: Dokler občutite takšne učinke, ne smete voziti ali upravljati z orodji ali stroji.
English: This should include laboratory evaluation, particularly serum creatinine.
Slovenian: Nadzor mora vključevati laboratorijske preiskave, zlasti kreatinin v serumu.
English: • A disorder in which the body's immune system attacks part of the peripheral nervous system
Slovenian: • bolezen, pri kateri imunski sistem v telesu napade del perifernega živčevja
English: For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Slovenian: Tako je na primer mogoče pričakovati, da ima od 15 do 20 % azijske populacije zmanjšano presnovo.
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100 % mortality).
Slovenian: Ta študija je potrdila izsledke zgodnejše, prospektivne študije, v kateri so ugotovili pozitiven izid pri preskušancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100 % umrljivostjo).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika, vendar čas običajno ne sme presegati 24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku), razen če ni rekonstitucija opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Slovenian: Preverjanja identifikacije in občutljivosti na protimikrobno zdravilo pri vsakem takem izolatu je treba ponoviti, če pa je rezultat potrjen, je treba izolat poslati v referenčni laboratorij.
English: Maximum increase in prothrombin time was approximately 2-fold
Slovenian: Največje podaljšanje protrombinskega časa je bilo približno 2-kratno.
English: The majority (> 94 %) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Slovenian: Večina (> 94 %) celotne radioaktivnosti se tako po peroralni kot po intravenski uporabi izloči v prvih 96 urah.
English: The recommended dosing regimen for prophylaxis is the same as for treatment in the respective age groups.
Slovenian: Priporočeni režim odmerjanja pri profilaksi je enak kot pri zdravljenju pri ustreznih starostnih skupinah.
English: Insufficient evidence
Slovenian: Ni dovolj dokazov
English: This enzyme exhibits genetic polymorphism.
Slovenian: Ta encim kaže genetski polimorfizem.
English: Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Slovenian: Bolniki z oslabelim imunskim sistemom ali s težkimi okužbami bodo morda za preprečitev ponovitve okužbe potrebovali dolgotrajno zdravljenje.
English: Dosage adjustment (Adults)
Slovenian: Prilagajanje odmerka (odrasli)
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Slovenian: Od teh 7 bolnikov so 3 imeli okužbo oči, 1 okužbo sinusov in 3 diseminirano okužbo.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Slovenian: Ker boste zdravilo dobivali pod natančnim zdravniškim nadzorom, je malo verjetno, da bi bil kakšen odmerek izpuščen.
English: • Treatment of invasive aspergillosis.
Slovenian: • zdravljenje invazivne aspergiloze
English: Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children.
Slovenian: Sončne opekline ali hude kožne reakcije po izpostavljanju svetlobi ali soncu so bile pogostejše pri otrocih.
English: Depending upon your response to treatment, your doctor may increase or decrease the daily dose.
Slovenian: Odvisno od vašega odziva na zdravljenje bo zdravnik morda povečal ali zmanjšal vaš dnevni odmerek..
English: Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:
Slovenian: Drugi pomembni neželeni učinki z neznano pogostnostjo, pri katerih morate nemudoma obvestiti zdravnika:
English: Detailed information on dosage recommendations is provided in the following table:
Slovenian: Podrobne informacije o priporočilih za odmerjanje prikazuje naslednja preglednica:
English: Interaction Geometric mean changes (%)
Slovenian: Interakcija sprememba geometrične srednje vrednosti (%)
English: 1 Includes febrile neutropenia and neutropenia.
Slovenian: 1 Vključuje febrilno nevtropenijo in nevtropenijo.
English: Candida Species
Slovenian: Vrsta Candida
English: However, this reduced response was not correlated with elevated MICs.
Slovenian: Vendar pa ta zmanjšan odziv ni bil v korelaciji s povečanimi minimalnimi inhibitornimi koncentracijami (MIK).
English: Clinical studies examining QTc interval
Slovenian: Klinične študije, ki so preučevale interval QTc
English: Treatment should be as short as possible, however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Slovenian: Trajanje zdravljenja mora biti čim krajše, če pa se na podlagi ocene koristi in tveganj zdravljenje nadaljuje (glejte poglavje 4.2), se lahko pogostost nadzora zmanjša na enkrat mesečno, če ni sprememb vrednosti testov jetrne funkcije.
English: The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.
Slovenian: Večina nenormalnih testov jetrne funkcije je izginila med zdravljenjem brez prilagoditve odmerka, ali pa po prilagoditvi odmerka, vključno s prekinitvijo zdravljenja.
English: • Abnormal sense of taste
Slovenian: • nenormalno zaznavanje okusa
English: • Sinus bradycardia
Slovenian: • sinusna bradikardija,
English: • Treatment of serious fungal infections caused by Scedosporium spp.
Slovenian: • zdravljenje hudih glivičnih okužb, ki jih povzročajo Scedosporium spp.
English: • Bleeding in the eye
Slovenian: • krvavitve v očesu
English: Post-marketing data suggest there might be a higher occurrence of skin reactions (especially erythema) in the paediatric population compared to adults.
Slovenian: Podatki iz obdobja trženja kažejo, da je možna večja pojavnost kožnih reakcij (zlasti eritem) pri pediatrični populaciji v primerjavi z odraslimi.
English: Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Slovenian: Običajne študije farmakološke varnosti, genotoksičnosti in karcinogenega potenciala niso kazale posebnega tveganja za človeka.
English: The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Slovenian: Medsebojna delovanja v preglednici so predstavljena v sledečem vrstnem redu: kontraindikacije, delovanja, ki potrebujejo prilagajanje odmerka ter skrben klinični in/ali biološki nadzor, in nazadnje delovanja, ki nimajo pomembnih farmakokinetičnih interakcij, a bi lahko imela klinični pomen v tem terapevtskem področju.
English: In the light of these data the duration of treatment of the intravenous formulation should be no longer than 6 months.
Slovenian: V luči teh podatkov zdravljenje z intravenskim pripravkom ne sme trajati več kot 6 mesecev.
English: Blood products and short-term infusion of concentrated solutions of electrolytes:
Slovenian: Krvni pripravki in kratkotrajne infuzije koncentriranih raztopin elektrolitov:
English: : Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Slovenian: : Sedem (3 popolni, 4 delni odzivi) od 17 bolnikov je bilo uspešno zdravljenih z vorikonazolom.
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180 days after HSCT.
Slovenian: Uspešnost je bila opredeljena kot zmožnost nadaljevanja profilakse s preiskovanim zdravilom 100 dni po HSCT (brez prekinitve > 14 dni) in preživetje 180 dni po HSCT brez dokazane ali verjetne IGO.
English: Medicinal product [Mechanism of Interaction]
Slovenian: Zdravilo [mehanizem interakcije]
English: • Abnormal electrocardiogram (ECG)
Slovenian: • nenormalen elektrokardiogram (EKG)
English: Packs of 1 or 5 vials.
Slovenian: Pakiranja po 1 ali 5 vial.
English: Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Slovenian: Interakcije med vorikonazolom in drugimi zdravili so navedene v spodnji preglednici (enkrat na dan kot “QD”, dvakrat na dan kot “BID”, trikrat na dan kot “TID” in ni določeno kot “ND”).
English: • Existing symptomatic arrhythmias
Slovenian: • obstoječe simptomatske aritmije,
English: 8 See section 4.4.
Slovenian: 8 Glejte poglavje 4.4.
English: 6 See “Visual impairments” paragraph in section 4.8.
Slovenian: 6 Glejte odstavek "Okvare vida" v poglavju 4.8.
English: The median treatment duration was 15 days in both treatment arms.
Slovenian: Mediano trajanje zdravljenja je bilo v obeh terapevtskih krakih 15 dni.
English: • Deterioration of brain function that is a serious complication of liver disease
Slovenian: • poslabšanje delovanja možganov, ki je resen zaplet bolezni jeter
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Slovenian: Analiza varnostnih podatkov ni pokazala klinično pomembnih razlik glede na starost, raso ali spol.
English: One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
Slovenian: V eno študijo so vključili 31 bolnikov z možno, potrjeno ali verjetno invazivno aspergilozo (IA), od katerih je 14 bolnikov imelo potrjeno ali verjetno IA in so jih vključili v analize učinkovitosti MITT.
English: Patients less than 40 kg**
Slovenian: bolniki s telesno maso manj kot 40 kg **
English: Prophylaxis in Adults and Children
Slovenian: Profilaksa pri odraslih in otrocih
English: The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Slovenian: Zmanjšanega odmerka in/ali pogostnosti jemanja vorikonazola in flukonazola, ki bi preprečil pojav tega učinka, niso ugotovili.
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Slovenian: Smer puščice za vsak farmakokinetični parameter temelji na 90 % intervalu zaupanja razmerja geometrične srednje vrednosti, ki je lahko znotraj (↔), pod (↓) ali nad (↑) območjem 80-125 %.
English: This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Slovenian: Ta presnovek deluje minimalno antimikotično in ne prispeva k celokupni učinkovitosti vorikonazola.
English: A single adverse reaction of photophobia of 10 minutes duration was reported.
Slovenian: Poročali so o enem samem neželenem učinku, in sicer o fotofobiji, ki je trajala 10 minut.
English: The inter-individual variability of voriconazole pharmacokinetics is high.
Slovenian: Interindividualna variabilnost farmakokinetike vorikonazola je velika.
English: • Breathing difficulties.
Slovenian: • težave z dihanjem
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Slovenian: Po 180 dneh je bila stopnja preživetja 80,0 % (32/40), po 1 letu pa 70,0 % (28/40).
English: The primary endpoint was the rate of occurrence of proven and probable IFI during the first year after HSCT.
Slovenian: Primarni opazovani dogodek je bila stopnja pogostnosti dokazane in verjetne IGO v prvem letu po HSCT.
English: Women of child-bearing potential must always use effective contraception during treatment.
Slovenian: Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem vedno uporabljati učinkovito kontracepcijo.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Slovenian: Zdravljenje se lahko začne, preden so znani izvidi kultur in drugih laboratorijskih študij; ko so ti izvidi na voljo, je treba antiinfektivno zdravljenje ustrezno prilagoditi.