FrancophonIA/ELRC3.0 huggingface dataset:
English: and associated names for which the MAH is F. HoffmanLa Roche Ltd.
Slovenian: in povezanih imen, katerih imetnik dovoljenja za promet z zdravilom je F. Hoffman - La Roche Ltd. Napotitveni postopek je bil sprožen na sestanku decembra 2014.
English: Section 4.2 - Posology and methods of administration
Slovenian: Poglavje 4.2 - Odmerjanje in načini uporabe
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee;
Slovenian: • odbor je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom;
English: and associated names.
Slovenian: in povezana imena.
English: There are no MAH-sponsored studies of CMV treatment in oncology patients.
Slovenian: Ni študij zdravljenja CMV pri onkoloških bolnikih, ki bi jih sponzoriral imetnik dovoljenja za promet z zdravilom.
English: There are no MAH-sponsored studies of CMV treatment in stem cell transplant recipients.
Slovenian: Ni študij zdravljenja CMV pri prejemnikih presajenih matičnih celic, ki bi jih sponzoriral imetnik dovoljenja za promet z zdravilom.
English: Package Leaflet
Slovenian: Navodilo za uporabo
English: The first renewal procedure for the vaccine was finalised in June 2004.
Slovenian: Prvi postopek za podaljšanje dovoljenja za cepivo se je končal junija 2004.
English: London, June 2008 EMEA/532090/2007- Rev.1
Slovenian: London, junij 2008 EMEA/532090/2007- Rev.1
English: The initial mutual recognition procedure was finalised on 24 June 1999 and eleven other Member States authorised the product at this time.
Slovenian: Prvotni postopek medsebojnega priznavanja je bil zaključen dne 24. junija 1999, takrat pa je enajst drugih držav članic izdalo dovoljenja za promet s tem zdravilom.
English: The CVMP Opinion was adopted on 17 April 2007 and the subsequent Commission Decision on 29 June 2007.
Slovenian: Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto dne 17. aprila 2007, s tem povezana odločba Komisije pa dne 29. junija 2007
English: EMEA/532090/2007-Rev.1
Slovenian: EMEA/532090/2007-Rev.1-SL
English: Denmark could not agree with the granting of the marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use (CVMP).
Slovenian: Danska se z odobritvijo dovoljenja za promet z zdravilom ni mogla strinjati in zadevo napotila na Koordinacijsko skupino za medsebojno priznavanje in decentralizirane postopke (CMD(v)) in naknadno na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: In March 2006 an application for a marketing authorisation for this vaccine was submitted, following a repeat use mutual recognition procedure, with Germany acting as Reference Member State.
Slovenian: Marca 2004 je bila vložena vloga za odobritev dovoljenja za promet s tem cepivom, na podlagi tega pa ponovno sprožen postopek za medsebojno priznavanje, v katerem je Nemčija delovala kot referenčna država članica.
English: The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/82/EC, the relevant EU guidelines and the relevant monographs of the Ph.Eur.
Slovenian: Proizvodnja in testiranje cepiva Bovilis BVD potekata v skladu z ustreznimi zahtevami Direktive 2001/82/ES, ustreznimi smernicami EU in ustreznimi monografijami Evropske farmakopeje.
English: Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.
Slovenian: Zdravilo Bovilis BVD je dovoljenje za promet najprej pridobilo v Nemčiji kot Bovilis BVD-MD.
English: The product is indicated for the active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with BVDV.
Slovenian: Zdravilo je indicirano za aktivno imunizacijo krav in telic, starih osem mesecev in več, za zaščito fetusov pred transplacentarno okužbo z BVDV.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/BOVILIS BVD-MD
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4) ZA ZDRAVILO BOVILIS BVD/BOVILIS BVD-MD
English: Therefore the requested additional specified extraneous testing requirement was not scientifically justified for Bovilis BVD.
Slovenian: Tako zahtevek za zahtevana dodatna posebna testiranja na tuje snovi za zdravilo Bovilis BVD ni znanstveno utemeljen.
English: Bovilis BVD/Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Slovenian: Zdravilo Bovilis BVD/Bovilis BVD-MD je cepivo z inaktiviranim virusom, ki vsebuje inaktiviran antigen virusnega seva citopatske goveje virusne diareje (GVD) C-86.
English: Denmark considered that the proposed testing regime to demonstrate freedom from extraneous agents was insufficient to ensure that Bovilis BVD/Bovilis BVD-MD would not interfere with their national eradication campaigns for certain animal diseases and that, therefore, the benefit/risk assessment for Bovilis BVD/Bovilis BVD-MD was unfavourable, authorisation of the product representing a potential serious risk to animal health.
Slovenian: Danska je menila, da predlagani režim testiranja za predstavitev odsotnosti tujih snovi v zadostni meri ne zagotavlja, da zdravilo Bovilis BVD/Bovilis BVD-MD ne bi oviralo nacionalnih programov za izkoreninjenje določenih bolezni živali ter da razmerje med koristmi in tveganji za zdravilo Bovilis BVD/Bovilis BVD-MD ni ugodno, tako da bi morebitna odobritev dovoljenja za promet z zdravilom lahko pomenila možno resno tveganje za zdravje živali.
English: The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je zaključil, da je proizvodnja cepiva Bovilis BVD v skladu z načeli dobre proizvodne prakse, da se testiranja surovin na tuje snovi izvajajo v skladu z ustreznimi zahtevami ter da testiranja zaključenih serij zdravila Bovilis BVD na virus slinavke in parkljevke (FMDV), virus goveje levkemije (BLV), virus bolezni modrikastega jezika (BTV) in virusov za infekciozni goveji rinotraheitis (IBRV) niso potrebna za ustrezne monografije.
English: The CVMP concluded that the benefit - risk assessment for Bovilis BVD was favourable.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da je ocena razmerja med koristmi in tveganji za zdravilo Bovilis BVD ugodna.
English: During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Bovilis BVD/Bovilis BVD-MD.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je na zasedanju novembra 2006 sprožil napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Bovilis BVD/Bovilis BVD-MD. Imetnik dovoljenja za promet je bil naprošen za predložitev vseh podpornih podatkov, ki bi upravičili pozitivno razmerje med koristmi in tveganji za zdravljenje živali.
English: monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je opazil neskladnosti (v zvezi s testiranji na tuje snovi) v monografijah Evropske farmakopeje za inaktivirana cepiva za govedo in za obravnavanje tega vprašanja pisno zaprosil Evropsko direkcijo za kakovost zdravil (EDQM).
English: The CVMP considered that in general, the absence of extraneous agents in vaccines can be ensured by: GMP compliance of the production system
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je menil, da se lahko na splošno odsotnost tujih snovi pri cepivih lahko zagotovi z: upoštevanjem dobre proizvodne prakse v proizvodnem sistemu testiranje surovin na tuje snovi po potrebi testiranjem serij končnega zdravila na tuje snovi.
English: ● you are pregnant.
Slovenian: · če ste noseči.
English: The results of these prespecified analyses are as follows:
Slovenian: Rezultati teh vnaprej določenih analiz so naslednji:
English: It is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Slovenian: Pomembno je izbrati dobro validirano in robustno metodologijo, da se izognemo lažno negativnim ali lažno pozitivnim rezultatom.
English: The median age was 64 years.
Slovenian: Srednja starost je bila 64 let.
English: every 3 weeks.
Slovenian: dne vsake 3 tedne).
English: Pack of 1 vial.
Slovenian: Pakiranje po 1 vialo.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika morate zdravilo uporabiti takoj.
English: • lack of energy,
Slovenian: · pomanjkanje energije,
English: Your doctor will discuss this with you.
Slovenian: Zdravnik se bo o tem pogovoril z vami.
English: Two of the eight cases did not have radiological confirmation via MRI.
Slovenian: Dva od osmih primerov nista bila radiološko potrjena z MRI.
English: The most serious adverse reactions were:
Slovenian: Najresnejši neželeni učinki so bili:
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 klinično ustreznih podskupin.
English: Discuss with your doctor to make sure that you do not combine these medicine.
Slovenian: Posvetujte se s svojim zdravnikom in se tako prepričajte, da ne boste prejeli kombinacije teh zdravil.
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Slovenian: Objektivnih (delnih ali popolnih) radioloških odgovorov (kriterij po Macdonaldu) ni bilo.
English: f Observed in pediatric population only
Slovenian: f Opaženo samo pri pediatrični populaciji.
English: These results have been confirmed through an independent radiological review.
Slovenian: Te rezultate je potrdil neodvisen radiološki pregled.
English: ● Risk Management Plan (RMP)
Slovenian: ZDRAVILA Načrt za obvladovanje tveganja (RMP)
English: Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry.
Slovenian: Adjuvantno zdravljenje s taksani je bilo dovoljeno le, če je bilo zaključeno najmanj 12 mesecev pred vstopom v preskušanje.
English: • spontaneous reporting,
Slovenian: · pri spontanem poročanju;
English: Seven patients in each arm had an objective response.
Slovenian: Sedem bolnikov iz vsake skupine je imelo objektivni odgovor na zdravljenje.
English: Both co-primary objectives were met:
Slovenian: Oba primarna cilja sta bila dokazana:
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Slovenian: Če je indicirano, zdravljenje dokončno ukinemo ali začasno prekinemo, kot je opisano v poglavju 4.4.
English: Overall Survival 3
Slovenian: Celokupno preživetje 3
English: Objective response rate was low in both treatment arms and the difference was not significant.
Slovenian: Objektivni odgovor na zdravljenje je bil nizek pri obeh zdravljenih skupinah in razlika ni bila signifikantna.
English: South San Francisco, CA 94080-4990 USA
Slovenian: South San Francisco, CA 94080-4990 ZDA
English: The incidence varied between 10% (4/40) and 20% (3/15).
Slovenian: Incidenca se je gibala med 10 % (4/40) in 20 % (3/15).
English: Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
Slovenian: Nekateri od teh neželenih učinkov so privedli do različnih stopenj izgube vida, vključno s trajno slepoto.
English: Please consult your doctor for more information.
Slovenian: Za več informacij se posvetujte s svojim zdravnikom.
English: • problems with the eyes (including increased production of tears),
Slovenian: · težave z očmi (vključno s povečanim solzenjem),
English: Genentech, Inc. 1 Antibody Way Oceanside, CA 92056 USA
Slovenian: 1 Antibody Way Oceanside, CA 92056 ZDA
English: Overall Survival (final analysis)***
Slovenian: Celokupno preživetje (končna analiza)***
English: which may be severe.
Slovenian: ki je lahko hudo.
English: Avastin may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo Avastin lahko povzroči tudi spremembe rezultatov laboratorijskih testov, ki jih izvaja vaš zdravnik.
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 s svojim zdravnikom, če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje krvi iz kakršnih koli razlogov;
English: Systemic effects following intravitreal use
Slovenian: Sistemski učinki po intravitrealni uporabi
English: No specific studies in animals have been conducted to evaluate the effect on fertility.
Slovenian: Specifičnih študij na živalih za oceno učinka na plodnost niso izvajali.
English: Low albumin and high tumour burden are generally indicative of disease severity.
Slovenian: Nizek albumin in visoko tumorsko breme sta splošna pokazatelja resnosti bolezni.
English: Day 1, prior to FOLFOX-4, every 2 weeks
Slovenian: 1. dan, pred FOLFOX-4, vsaka 2 tedna
English: (≥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: pogosti (³ 1/100 do < 1/10), občasni (³ 1/1.000 do < 1/100), redki (³ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: According to the two-compartmental model, the elimination half-life is 18 days for a typical female patient and 20 days for a typical male patient.
Slovenian: Glede na dvoprostorni model je razpolovni čas izločanja 18 dni za tipično bolnico in 20 dni za tipičnega bolnika.
English: Overall Survival (OS)
Slovenian: Celokupno preživetje (OS)
English: ***The final analysis of overall survival was performed when 266 deaths, which account for 73.7 % of enrolled patients, were observed.
Slovenian: ***Končna analiza celokupnega preživetja je bila opravljena, ko je nastopilo 266 smrti, kar je predstavljalo 73,7 % vključenih bolnic.
English: A total of 820 patients were randomised.
Slovenian: Skupno so randomizirali 820 bolnikov.
English: Date of latest renewal: 14 January 2015
Slovenian: Datum prve odobritve: 12. januar 2005 Datum zadnjega podaljšanja: 14. januar 2015
English: Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Slovenian: Študij za oceno mutagenega in kancerogenega potenciala bevacizumaba niso izvajali.
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) prosimo glejte poglavje 5.1.
English: In trial E2100, patients were treated until disease progression.
Slovenian: V preskušanju E2100 so bolnike zdravili do napredovanja bolezni.
English: Very rare cases of hypertensive encephalopathy have been reported, some of which were fatal.
Slovenian: Poročali so o zelo redkih primerih hipertenzivne encefalopatije, od katerih so bili nekateri smrtni.
English: When Avastin is injected directly into the eye (unapproved use), the following side effects may occur:
Slovenian: Kadar zdravilo Avastin injiciramo neposredno v oko (neodobrena uporaba), se lahko pojavijo naslednji neželeni učinki:
English: Prior hormonal therapy for the treatment of metastatic disease was allowed.
Slovenian: Za zdravljenje metastatske bolezni je bilo dovoljeno predhodno hormonsko zdravljenje.
English: • high blood pressure,
Slovenian: · visok krvni tlak,
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Slovenian: Napredovanje metastatske bolezni je bilo zavrto, mikrovaskularna prepustnost pa zmanjšana.
English: IRF assessment
Slovenian: Ocena IRF
English: Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly-diagnosed high-grade glioma.
Slovenian: Na voljo ni dovolj podatkov, da bi določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje malignosti.
English: Elderly patients: No dose adjustment is required in the elderly.
Slovenian: Posebne populacije Starejši bolniki: za starejše bolnike prilagajanje odmerka ni potrebno.
English: Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Slovenian: Podatki o malformacijah ploda, ki so jih opazili v obdobju po prihodu zdravila na trg, so vključeni v poglavje 4.6 Plodnost, nosečnost in dojenje ter 4.8 Neželeni učinki.
English: Dose reduction for adverse reactions is not recommended.
Slovenian: Zmanjšanje odmerka zaradi neželenih učinkov ni priporočljivo.
English: ● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Slovenian: · to zdravilo lahko povzroči okužbe in zmanjša število vaših nevtrofilcev (vrsta krvnih celic, ki so pomembne za zaščito pred bakterijami);
English: • post-authorisation safety studies,
Slovenian: · v varnostnih študijah po pridobitvi dovoljenja za promet;
English: Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Please consult your doctor, even if these above statements were only applicable to you in the past.
Slovenian: Prosimo, da se posvetujete s svojim zdravnikom, če so se zgoraj navedene navedbe na vas nanašale v preteklosti.
English: Each pack of Avastin contains one vial.
Slovenian: Vsako pakiranje zdravila Avastin vsebuje 1 vialo.
English: Invasive dental procedures are also an identified risk factor.
Slovenian: Invazivni zobozdravstveni posegi predstavljajo dodatni dejavnik tveganja.
English: A systematic premedication is not warranted.
Slovenian: Sistematska premedikacija ni potrebna.
English: These could be signs and symptoms of bone damage in the jaw (osteonecrosis).
Slovenian: Le-ti so lahko znaki in simptomi poškodbe kosti v čeljusti (osteonekroze).
English: If you have an allergic reaction, tell your doctor or a member of the medical staff straight away.
Slovenian: Če se pri vas pojavi alergijska reakcija, nemudoma obvestite zdravnika ali člana medicinskega osebja.
English: Do not stop treatment with Avastin unless you have discussed this with your doctor.
Slovenian: Ne prenehajte zdravljenja z zdravilom Avastin, ne da bi se o tem pogovorili s svojim zdravnikom.
English: FIGO staging version dated 1988 was used in this trial.
Slovenian: V tem preskušanju so uporabili klasifikacijo FIGO, verzija iz leta 1988.
English: It is not known whether bevacizumab is excreted in human milk.
Slovenian: Ni znano, ali se bevacizumab izloča v materino mleko.
English: Therefore, caution should be exercised before initiating therapy in these patients.
Slovenian: Zato je pred začetkom zdravljenja pri teh bolnikih potrebna previdnost.
English: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Switzerland
Slovenian: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Švica
English: ● It is possible that Avastin can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Slovenian: · možno je, da lahko zdravilo Avastin povzroči preobčutljivost in/ali reakcije, povezane z infundiranjem (reakcije, povezane z injiciranjem zdravila).
English: Please discuss with your doctor if you noticed this previously.
Slovenian: Pogovorite se s svojim zdravnikom, če ste to že kdaj opazili;
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Slovenian: Dolgoročni vplivi zdravljenja z bevacizumabom na plodnost niso znani.
English: Effects on wound healing were shown to be fully reversible.
Slovenian: Učinki na celjenje ran so bili popolnoma reverzibilni.
English: Data are unadjusted for the differential time on treatment.
Slovenian: Podatki niso prilagojeni različno dolgi dobi zdravljenja.
English: Before initiating Avastin, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Avastin je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: In patients who have previously received or are receiving intravenous bisphosphonates invasive dental procedures should be avoided, if possible.
Slovenian: Pri bolnikih, ki so predhodno prejemali ali trenutno prejemajo intravenske difosfonate, se je treba, če je to mogoče, izogibati invazivnim zobozdravstvenim posegom.
English: Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Slovenian: Posvetujte se s svojim zdravnikom, če imate rak v metastatski obliki, ki je prizadel vaše možgane;
English: Radiotherapy
Slovenian: Radioterapija
English: Later infusions may be given to you over 30 minutes.
Slovenian: Nadaljnje infuzije boste lahko prejeli v 30 minutah.
English: Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility.
Slovenian: Predmenopavzalne ženske (ženske z menstrualnim ciklom) boste morda opazile, da bodo vaše menstruacije postale neredne ali bodo izostale, oziroma bo vaša plodnost zmanjšana.
English: There are no clinical trial data on the use of Avastin in pregnant women.
Slovenian: Iz kliničnih preskušanj ni podatkov o uporabi zdravila Avastin pri nosečnicah.
English: It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease.
Slovenian: Pomembno je, da vaš zdravnik ve, če ste kdaj prejeli antracikline (na primer doksorubicin, specifično vrsto kemoterapije, ki jo uporabljajo pri zdravljenju nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen;
English: A total of 16 patients (4.4%) were > 75 years old.
Slovenian: Skupaj je bilo 16 bolnic (4,4 %) starejših od 75 let.
English: If you experience symptoms that affect your vision or concentration, or your ability to react, do not drive and use machines until symptoms disappear.
Slovenian: Če se pri vas pojavijo simptomi, ki vplivajo na vid oziroma koncentracijo ali vašo sposobnost odzivanja, ne vozite ali uporabljajte strojev, dokler simptomi ne izginejo.
English: It is recommended that treatment be continued until disease progression or unacceptable toxicity (see section 5.1, study MO22224).
Slovenian: Priporočljivo je, da se zdravljenje nadaljuje do napredovanja bolezni ali nesprejemljive toksičnosti (glejte poglavje 5.1, študija MO22224).
English: However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR= 0.91).
Slovenian: Vendar pa povečanje primarnega končnega cilja - celokupnega preživetja - za 2 meseca ni bilo signifikantno (razmerje ogroženosti = 0,91).
English: You should discuss this with your doctor.
Slovenian: O tem se pogovorite s svojim zdravnikom.