FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Palonosetron Accord work?
Slovenian: Kako zdravilo Palonosetron Accord deluje?
English: the change to the authorisation is Eli Lilly.
Slovenian: Družba, ki je vložila vlogo za spremembo dovoljenj za promet z zdravilom, je Eli Lilly.
English: It may request a retive opinion.
Slovenian: Predlagatelj je zaprosil za ponovni pregled mnenja.
English: EMEA/H/C/000572/WS/007 EMEA/H/C/000573/W
Slovenian: EMEA/H/C/000552/WS/0076 EMEA/H/C/000572/WS/0076 EMEA/H/C/000573/WS/0076
English: There was also insufficient evidence th time, which is important when treating a long-term condition.
Slovenian: Prav tako ni bilo zadostnih dokazov, da je ta učinek mogoče vzdrževati dlje časa, kar je pomembno pri zdravljenju dolgotrajnih bolezni.
English: Neurotransmitters are chemica cells to communicate with one another.
Slovenian: Nevrotransmitorji so kemične snovi, ki omogočajo medsebojno komunikacijo živčnih celic.
English: The CHMP noted that the studies had not proven that duloxetine would provide a r the indication applied for.
Slovenian: Odbor CHMP je ugotovil, da študije niso dokazale, da duloksetin omogoča bistvene koristi pri indikaciji, za katero je bilo vloga vložena.
English: It works by preventi the neurotransmitters 5-hydroxytrypamine (also called serotonin) and no back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovni privzem nevrotransmitorjev 5-hidroksitripamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjači.
English: What consequences does this refusal have for patients in clin compassionate use programm
Slovenian: Kakšne posledice ima ta zavrnitev za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
English: What were the CHMP's main concerns that led to the refusal to the
Slovenian: Kateri so bili glavni zadržki CHMP, ki so privedli do zavrnitve spremembe dovoljenj za promet z zdravili?
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage extremities that can occur in patients with diabetes).
Slovenian: Zdravilo Ariclaim se uporablja za zdravljenje bolečin zaradi diabetične periferne nevropatije (poškodbe živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
English: MP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Slovenian: Dne 21. julija 2011 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili Ariclaim, Cymbalta in Xeristar, ki vsebujejo duloksetin.
English: In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (nonsteroidal anti-inflammatory drugs).
Slovenian: Poleg odobrenih načinov uporabe so nameravali vsa tri zdravila uporabljati za zdravljenje zmerne do hude kronične (dolgotrajne) somatske bolečine pri bolnikih, ki ne jemljejo protibolečinskih zdravil NSAID (nesteroidnih antirevmatikov).
English: ts of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in ne or placebo (a nts taking them in combination with NSAIDs.
Slovenian: Družba je predstavila rezultate petih glavnih študij pri 839 bolnikih s kronično somatsko bolečino: dve študiji pri bolnikih z bolečino v kolenu, ki jo je povzročil osteoartritis (otekanje in bolečina v sklepih) in tri študije pri bolnikih s kronično bolečino v križu.
English: Since these neurotransmitters are i of pain, blocking their re-uptake into nerve cells may improve the symptoms of p
Slovenian: Ker ti nevrotransmitorji sodelujejo pri zmanjševanju občutka bolečine, se lahko z zaviranjem njihovega ponovnega privzema v živčne celice izboljšajo tudi simptomi bolečine.
English: The change concerned the addition of a new e chronic somatic pain in patients not taking NSAIDs regularly.
Slovenian: Sprememba se je nanašala na dodatek nove indikacije, zdravljenja zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov.
English: Somatic pain is from the body surfaces (such as skin) or
Slovenian: Somatska bolečina izvira s telesnih površin (na primer s kože) ali iz mišično-skeletnih tkiv (kot so skeletne mišice, kosti in sklepi).
English: It does not include pain from h and intestines.
Slovenian: Ne vključuje pa bolečine, ki izvira iz notranjih organov, kot so želodec in prebavila.
English: Ariclaim, Cymbalta and Xeristar are medicines containin
Slovenian: Ariclaim, Cymbalta in Xeristar so zdravila, ki vsebujejo zdravilno učinkovino duloksetin.
English: By blocking their re-uptake, dul of these neurotransmitters in the spaces between these nerve cel communication between the cells.
Slovenian: Duloksetin z zaviranjem njihovega ponovnega privzema poveča količino teh nevrotrasmitorjev v prostorih med živčnimi celicami, s čimer se poveča stopnja komunikacije med celicami.
English: Patients in the studies were treated with duloxeti dummy treatment) with some patie effectiveness was the change in the severity of pain, as recorded by the patients after 12 or 13 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba resnosti bolečine, kot so jo vsakodnevno zabeležili bolniki na podlagi 11-točkovne lestvice po 12 ali 13 tednih zdravljenja.
English: The medicines are expected to work in the same way they do in diabetic periphera active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina duloksetin je zaviralec ponovnega privzema serotonina in noradrenalina.
English: The main measure of on an 11-point scale of the change elevant benefit in at its effect could be maintained over nformation was n elderly patients and its safety in the intended patients including the elderly.
Slovenian: Poleg tega bi potrebovali več podatkov o učinkih duloksetina pri starejših bolnikih in njegovi varnosti za bolnike, ki naj bi jih zdravili, vključno s starejšimi bolniki.
English: The CHMP therefore concluded that the benefits of d chronic somatic pain in patients not regularly taking NSAIDs had not been and recommended that
Slovenian: Odbor CHMP je zato sklenil, da dokazane koristi duloksetina pri zdravljenju zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov, večje od z njim povezanih tveganj.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CH
Slovenian: Agencija Evropske unije© Evropska agencija za zdravila, 2011.
English: The company informed the CHMP that there are currently no ongoing clinical t Cymb
Slovenian: Družba je obvestila odbor CHMP, da trenutno v Evropi ne poteka nobeno klinično preskušanje zdravil Ariclaim, Cymbalta in Xeristar pri bolnikih s kronično somatsko bolečino.
English: Page 2/2
Slovenian: 17. november 2011
English: uloxetine in the treatment of moderate to severe shown to outweigh its risks the change to the marketing authorisations be refused.
Slovenian: Kljub temu je odbor sklenil, da njegovi zadržki še vedno niso zadovoljivo odpravljeni ter potrdil svoje prvotno negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili.
English: The company that applied for examination of the opinion within 15 days of receipt of notification of this nega
Slovenian: Po proučitvi utemeljitve za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 17. novembra 2011 potrdil zavrnitev spremembe za dovoljenja za promet z zdravili.
English: 1 pre-filled syringe with needle safety guard
Slovenian: injekcijskih brizg napolnjena injekcijska brizga (steklena) z varnostno zaščito za iglo napolnjena injekcijska brizga (steklena) z varnostno zaščito za iglo
English: You will also have blood tests during your treatment.
Slovenian: Prav tako boste med zdravljenjem opravljali preiskave krvi.
English: Details on how to minimise the safety concerns through appropriate monitoring and management.
Slovenian: Podrobnosti, kako zmanjšati varnostna tveganja z ustreznim spremljanjem in obvladovanjem.
English: For all subgroup analyses, formal statistical testing was not planned.
Slovenian: Za vse analize podskupin formalno statistično testiranje ni bilo načrtovano.
English: 31 July 2021
Slovenian: 31. julij 2021
English: • Your doctor will monitor you carefully during the first infusion.
Slovenian: • Zdravnik vas bo med prvo infuzijo skrbno nadziral.
English: Do not try to treat yourself with other medicines.
Slovenian: Ne poskušajte se zdraviti sami z drugimi zdravili.
English: Before your treatment, your doctor will check your general health.
Slovenian: Pred zdravljenjem bo zdravnik preveril vaše splošno zdravstveno stanje.
English: • have been told that your cancer has spread to your brain
Slovenian: • so vam povedali, da se vam je rak razširil v možgane,
English: NE (NE)
Slovenian: NO (NO)
English: Pack of one vial.
Slovenian: Pakiranje z eno vialo.
English: This medicine should not be given to children or adolescents below 18 years of age.
Slovenian: Tega zdravila ne smejo dobiti otroci ali mladostniki, mlajši od 18 let.
English: The time to onset was 18 and 33 days.
Slovenian: Čas do pojava je bil 18 in 33 dni.
English: Aseptic preparation, handling and storage
Slovenian: Aseptična priprava, ravnanje in shranjevanje
English: Your healthcare professional will throw away any medicines that are no longer being used.
Slovenian: Zdravstveni delavec bo zavrgel vso zdravilo, ki se ne uporablja več.
English: • Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
Slovenian: • Zdravniku morate povedati, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
English: Median in months
Slovenian: Mediana v mesecih
English: For the treatment to be fully effective, it is very important to keep having the infusions.
Slovenian: Da bi bilo zdravljenje resnično učinkovito, je zelo pomembno, da nadaljujete s prejemanjem infuzij.
English: The median age was 73 years.
Slovenian: Mediana starost je bila 73 let.
English: A total of 931 patients were enrolled.
Slovenian: Skupno so vključili 931 bolnikov.
English: Your doctor may:
Slovenian: Vaš zdravnik:
English: The primary efficacy outcome was overall survival.
Slovenian: Primarni izid učinkovitosti je bilo celokupno preživetje.
English: The study enrolled a total of 438 patients and had two patient cohorts.
Slovenian: Študija je skupaj vključila 438 bolnikov in je imela dve kohorti.
English: The frequency is based on the program wide exposure.
Slovenian: Pogostnost temelji na široki izpostavljenosti.
English: Reduce infusion rate or interrupt.
Slovenian: Zmanjšajte hitrost infundiranja ali ga prekinite.
English: • protein in urine (proteinuria)
Slovenian: • beljakovine v urinu (proteinurija)
English: ATC code: L01XC32
Slovenian: Oznaka ATC: L01XC32
English: This is because stopping treatment may stop the effect of the medicine.
Slovenian: S prenehanjem zdravljenja namreč lahko preneha tudi učinek zdravila.
English: OS results for each of steps 2 and 3 could be formally tested for statistical significance only if the result in the preceding step was statistically significant.
Slovenian: Rezultati celokupnega preživetja za vsakega od korakov 2 in 3 so lahko formalno testirali glede statistične značilnosti le, če je bil rezultat v prejšnjem koraku statistično značilen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: • Brief introduction to atezolizumab (indication and purpose of this tool)
Slovenian: • Kratko predstavitev atezolizumaba (indikacija in namen te kartice).
English: This regimen is administered every three weeks for four cycles.
Slovenian: Ta shema se aplicira na vsake tri tedne v skupno štirih ciklih.
English: These results should be interpreted with caution due to the open-label design of the study.
Slovenian: Te rezultate je treba zaradi odprte zasnove študije interpretirati previdno.
English: • No decline in ECOG performance status
Slovenian: • brez poslabšanja stanja zmogljivosti po ECOG;
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovi dokumentaciji.
English: This includes medicines obtained without a prescription, including herbal medicines.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta, vključno z zdravili rastlinskega izvora.
English: The Marketing Authorisation Holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Nederland Roche Nederland B.V.
Slovenian: Roche Nederland B.V.
English: The stratified log-rank p-value was 0.41 and therefore the results are considered not statistically significant in this population.
Slovenian: Stratificirana log-rang p-vrednost je bila 0,41, zato se rezultati v tej populaciji ne štejejo kot statistično značilni.
English: The storage details are as follows:
Slovenian: Podrobnosti shranjevanja so:
English: It is used when this cancer is advanced.
Slovenian: Pri tem raku ga uporabljamo, če je rak napredoval.
English: The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
Slovenian: Smernice za obravnavo teh neželenih učinkov so opisane v poglavjih 4.2 in 4.4.
English: • have an auto-immune disease (a condition where the body attacks its own cells)
Slovenian: • imate kakšno avtoimunsko bolezen (bolezen, pri kateri telo napade svoje lastne celice),
English: The median survival follow-up is 17 months.
Slovenian: Mediano spremljanje preživetja je 17 mesecev.
English: Antibodies are cleared principally by catabolism.
Slovenian: Protitelesa se odstranijo predvsem s katabolizmom.
English: Efficacy in elderly patients
Slovenian: Učinkovitost pri starejših bolnikih
English: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Tecentriq pri otrocih in mladostnikih, mlajših od 18 let, nista dokazani.
English: Patients were staged according to the American Joint Committee on Cancer (AJCC) 7th edition.
Slovenian: Stadij je bil pri bolnikih določen v skladu s 7. izdajo AJCC (American Joint Committee on Cancer).
English: • Do not use if this medicine is cloudy, discoloured or contains particles
Slovenian: • Zdravila ne uporabljajte, če je motno, obarvano ali vsebuje delce.
English: They may happen weeks or months after your last dose.
Slovenian: Ti neželeni učinki se lahko pojavijo še tedne ali mesece po zadnjem odmerku zdravila.
English: It is important that you also read the package leaflet for nab-paclitaxel.
Slovenian: Pomembno je, da preberete tudi navodilo za uporabo nab-paklitaksela.
English: • have had serious side effects because of other antibody therapies that help your immune system to fight cancer
Slovenian: • ste imeli resne neželene učinke zaradi drugih zdravljenj s protitelesi, ki pomagajo vašemu imunskemu sistemu, da premaguje raka,
English: Overall, ADA status appeared to have no clinically relevant impact on safety.
Slovenian: Prisotnost ADA po vsem sodeč ni klinično pomembno vplivala na varnost.
English: Immune-related adverse reactions affecting more than one body system have been observed.
Slovenian: Opazili so imunsko pogojene neželene učinke, ki vplivajo na več kot en organski sistem.
English: • low levels of adrenal hormones
Slovenian: • nizka raven nadledvičnih hormonov
English: Updated PFS results are also presented in Figures 4 and 5.
Slovenian: Posodobljeni rezultati PFS so prav tako prikazani na slikah 4 in 5.
English: Tecentriq may cause some side effects that you must tell your doctor about straight away.
Slovenian: Zdravilo Tecentriq lahko povzroči nekatere neželene učinke, o katerih morate takoj obvestiti svojega zdravnika.
English: Reported in studies outside the pooled dataset.
Slovenian: Zabeleženo v študijah izven združenih podatkov.
English: • have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Slovenian: • imate ali ste imeli kronično virusno okužbo jeter, vključno s hepatitisom B (HBV) ali hepatitisom C (HCV),
English: • have been given a live, attenuated vaccine
Slovenian: • ste se cepili z živim, oslabljenim cepivom.
English: • Give you other medicines to prevent complications and reduce symptoms.
Slovenian: • vam lahko da druga zdravila, da prepreči zaplete in zmanjša simptome,
English: This is because the effects of Tecentriq in this age group are not known.
Slovenian: Učinki zdravila Tecentriq v tej starostni skupini namreč niso znani.
English: A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body.
Slovenian: Monoklonsko protitelo je vrsta beljakovine in je zgrajeno tako, da prepozna specifično tarčo v telesu in se nanjo veže.
English: Asian patients
Slovenian: Azijski bolniki
English: No dose reduction was allowed.
Slovenian: Zmanjšanje odmerka ni bilo dovoljeno.
English: It is important that you also read the package leaflet for these medicines.
Slovenian: Pomembno je, da si preberete tudi navodila za uporabo teh zdravil.
English: A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Slovenian: Skupno je bilo vključenih 1225 bolnikov, v skladu z načrtom za analizo so prvih 850 randomiziranih bolnikov vključili v primarno analizo učinkovitosti.
English: The following information is intended for healthcare professionals only: Instructions for dilution
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za redčenje
English: • you are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na atezolizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • You will not be given Tecentriq if you are pregnant unless your doctor considers it necessary.
Slovenian: • Če ste noseči, zdravila Tecentriq ne boste dobili, razen če vaš zdravnik meni, da je nujno.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznak Uporabno do/EXP.
English: Tecentriq is available in a pack containing 1 glass vial.
Slovenian: Zdravilo Tecentriq je na voljo v pakiranjih, ki vsebujejo 1 stekleno vialo.
English: The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Slovenian: Uporabljene so naslednje kategorije pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
English: The use of in-line filter membranes is optional.
Slovenian: Uporaba linijskega membranskega filtra ni obvezna.
English: Primary efficacy endpoints n=185
Slovenian: Primarni opazovani dogodki učinkovitosti n = 185
English: A decision must be made whether to discontinue breast-feeding or to discontinue Tecentriq therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba ali za prenehanje dojenja ali za prenehanje uporabe zdravila Tecentriq, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: However, monoclonal antibodies are not expected to alter DNA or chromosomes.
Slovenian: Za monoklonska protitelesa ni pričakovano, da bi spremenila DNA ali kromosome.
English: • decreased number of lymphocyte (a type of white blood cells), which is associated with an increased risk of infection
Slovenian: • zmanjšano število limfocitov (vrste belih krvnih celic), ki je povezano s povečanim tveganjem okužbe
English: Do not co-administer other medicinal products through the same infusion line.
Slovenian: Drugih zdravil ne dajate sočasno z isto infuzijsko linijo.
English: Treatment with atezolizumab until loss of clinical benefit was permitted as defined by the following criteria:
Slovenian: Zdravljenje z atezolizumabom do izgube klinične koristi je bilo dovoljeno, kot je opredeljeno v naslednjih merilih:
English: Tell your doctor straight away if you notice any of the symptoms below:
Slovenian: Zdravnika morate takoj obvestiti, če opazite katerega od naslednjih simptomov:
English: Patients excluded from clinical trials
Slovenian: Bolniki, ki niso bili vključeni v klinična preskušanja
English: • myasthenia gravis, an illness that can cause muscle weakness
Slovenian: • miastenija gravis, bolezen, ki lahko povzroči šibkost mišic
English: *** Responses were ongoing in 63% of responders in the atezolizumab arm and in 21% of responders in the chemotherapy arm.
Slovenian: *** Odgovori so potekali pri 63 % odzivnih bolnikov v skupini z atezolizumabom in pri 21 % odzivnih bolnikov v skupini s kemoterapijo.
English: Isolated hypothyroidism may be managed with replacement therapy and without corticosteroids.
Slovenian: Izolirani hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem in brez kortikosteroidov.
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Tecentriq.
Slovenian: • Kartica mora vključevati tudi prostor za navedbo kontaktnih podatkov zdravnika in vsebovati opozorilo za zdravstvene delavce, ki kadarkoli zdravijo bolnika, tudi v nujnih stanjih, da bolnik uporablja zdravilo Tecentriq.
English: • Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Slovenian: • Opozorilo za bolnike glede pomena takojšnjega posvetovanja z zdravnikom, če imajo kateregakoli od navedenih znakov in simptomov, ter o pomembnosti dejstva, da se ne poskušajo zdraviti sami.
English: • Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
Slovenian: • odsotnost napredovanja tumorja na kritičnih anatomskih mestih (npr. leptomeningealna bolezen), ki jih pred ponovno uporabo zdravila ni mogoče enostavno obvladati in stabilizirati z zdravljenjem, dovoljenim po protokolu;
English: *The primary analysis population consists of the first 850 randomised patients
Slovenian: *Populacijo za primarno analizo sestavlja prvih 850 randomiziranih bolnikov.
English: Atezolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with atezolizumab.
Slovenian: Atezolizumaba se med nosečnostjo ne sme uporabljati, razen če bolničino klinično stanje zahteva zdravljenje z atezolizumabom.
English: Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
Slovenian: Stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) ≥ 2
English: If you notice any of the symptoms above, tell your doctor straight away.
Slovenian: Če opazite katerega od zgoraj naštetih simptomov, morate takoj obvestiti zdravnika.