FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with diabetic macular oedema, the average number of letters they could read in an eye test before treatment was about 59 to 60; in patients given Eylea monthly this improved by around 12 letters, and in those given Eylea every other month by around 11 letters.
Slovenian: Pri bolnikih z makularnim edemom, ki je posledica sladkorne bolezni, je bilo povprečno število črk, ki so jih bolniki lahko prebrali na očesnem testu pred začetkom zdravljenja, med 59 in 60; pri bolnikih, ki so vsak mesec prejemali zdravilo Eylea, se je to izboljšalo za približno 12 črk, pri tistih, ki pa so zdravilo prejemali vsak drugi mesec, pa za okoli 11 črk.
English: Eylea was also investigated in two other main studies involving 366 patients with macular oedema following CRVO.
Slovenian: Zdravilo Eylea so proučevali tudi v dveh drugih študijah, ki sta vključevali 366 bolnikov z makularnim edemom, ki je posledica zapore osrednje mrežnične vene.
English: For the full list of side effects of Eylea, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Eylea, glejte navodilo za uporabo.
English: For BRVO, around 53% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 27% of patients who received laser treatment.
Slovenian: Pri zapori veje vene je pri približno 53 % bolnikov, ki so prejemali zdravilo Eylea, na očesnem testu v 24. tednu prišlo do izboljšanja za 15 črk ali več v primerjavi s 27 % pri bolnikih, ki so prejemali lasersko zdravljenje.
English: Macular oedema following retinal vein occlusion
Slovenian: Makularni edem po zapori mrežnične vene
English: In myopic choroidal neovascularisation, Eylea was investigated in a main study involving 122 patients, which compared Eylea with a sham injection.
Slovenian: Pri miopični horoidalni neovaskularizaciji, ki jo povzroča kratkovidnost, so zdravilo Eylea proučevali v glavni študiji, v katero je bilo vključenih 122 bolnikov.
English: How is Eylea used?
Slovenian: Kako se zdravilo Eylea uporablja?
English: • impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
Slovenian: • okvaro vida zaradi makularnega edema (otekanja), ki je posledica zapore glavne vene, ki dovaja kri iz očesne mrežnice (tj. stanja, znanega kot zapora osrednje mrežnične vene), ali manjših ven v mrežnici (stanja, znanega kot zapora veje vene);
English: For CRVO, overall about 60% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 17% of those given sham injections.
Slovenian: Pri zapori osrednje mrežnične vene je pri približno 60 % bolnikov, ki so prejemali zdravilo Eylea, na očesnem testu v 24. tednu prišlo do izboljšanja za 15 črk ali več v primerjavi s 17 % pri bolnikih, ki so prejemali injekcije placeba.
English: The studies in patients with macular oedema following CRVO also looked at the effects of treatment on an as-needed basis after 24 weeks.
Slovenian: ki je posledica zapore osrednje mrežnične vene, so proučevali tudi učinke zdravljenja, ki se daje po potrebi po 24 tednih.
English: Eylea also produced a significant improvement in vision in patients with macular oedema following CRVO and BRVO.
Slovenian: Zdravilo Eylea je prav tako povzročilo znatno izboljšanje vida pri bolnikih z makularnim edemom, ki je posledica zapore osrednje mrežnične vene ali zapore veje vene.
English: Diabetic macular oedema
Slovenian: V študijah makularnega edema,
English: 1/1 M
Slovenian: 1/1 Z
English: l t o r
Slovenian: o č
English: For all bisphosphonates
Slovenian: Za vse difosfonate
English: Annex IV Conditions of the marketing authorisation
Slovenian: Dodatek IV Pogoji dovoljenja za promet z zdravilom
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Slovenian: Pristojni nacionalni organi, katerih delovanje smiselno usklajuje referenčna država članica, morajo zagotoviti naslednje:
English: The communication should be based on the “key communication messages document” agreed by CHMP and annexed to the assessment report.
Slovenian: Obveščanje mora potekati v skladu s „ključnim dokumentom o obvestilnih sporočilih“, ki ga je določil CHMP in je priložen poročilu o oceni.
English: National Competent Authorities should ensure that Health Care Professionals will be informed of the measures agreed by CHMP to minimise the risk of atypical femoral fractures.
Slovenian: Pristojni nacionalni organi morajo zagotoviti, da bodo zdravstveni delavci obveščeni o ukrepih, ki jih je sprejel CHMP za zmanjševanje tveganja za atipične zlome stegnenice.
English: The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Slovenian: Imetniki dovoljenj za promet z zdravili se morajo v roku dveh mesecev po odločbi Komisije povezati s pristojnimi nacionalnimi organi in se dogovoriti o časovnem načrtu za predložitev načrtov za obvladovanje tveganja.
English: The MAHs should submit/update the Risk Management Plans to reflect "atypical femoral fractures" as potential risk.
Slovenian: Imetniki dovoljenj za promet z zdravili morajo predložiti/posodobiti načrte za obvladovanje tveganja, tako da bodo „atipični zlomi stegnenice“ navedeni kot možno tveganje.
English: 7 multi-dose vials
Slovenian: 7 vial z več odmerki
English: Eye drops, solution Ocular use vial (glass)
Slovenian: 20 µg/ml kapljice za oko, raztopina okularna uporaba viala (steklena) 1 ml
English: Cutaneous use tube (alu)
Slovenian: Uporaba na koži tuba (aluminijasta) 60 g
English: What you need to know before you take <active substance>:
Slovenian: Kaj morate vedeti, preden boste vzeli <zdravilna učinkovina>:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Kot je ustrezno, lahko informacije o zdravilu naknadno posodobijo pristojni organi držav članic v povezavi z referenčnimi državami članicami v skladu s postopki, predpisanimi v poglavju 4 naslova III Direktive 2001/83/ES.
English: 4.8 Adverse events
Slovenian: 4.8 Neželeni učinki
English: Rare: hypersensitivity reactions
Slovenian: Redki: preobčutljivostne reakcije
English: You can also report side effects directly via [the national reporting system listed in Appendix V*].
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na [nacionalni center za poročanje, ki je naveden v Prilogi V*].
English: [The following sub-heading should appear at the end of this section] Reporting of suspected adverse reactions
Slovenian: [Na koncu tega poglavja je treba vključiti naslednje podpoglavje] Poročanje o domnevnih neželenih učinkih
English: If you develop a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals), stop using <invented name> and contact your doctor immediately.
Slovenian: Če se pri vas pojavi kožni izpuščaj (vključno z ranami na sluznicah, kot so usta, grlo, nos, oči, spolovila), takoj prenehajte uporabljati zdravilo <izmišljeno ime> in se obrnite na zdravnika.
English: If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, <active substance> treatment should be discontinued immediately and medical advice should be sought.
Slovenian: Če so prisotni simptomi ali znaki progresivnega kožnega izpuščaja (včasih povezan z mehurji ali lezijami na sluznici), je treba takoj prekiniti zdravljenje z <zdravilna učinkovina> in se posvetovati z zdravnikom.
English: Rare: may affect up to 1 in 1,000 people:
Slovenian: Redki: lahko se pojavijo pri največ 1 od 1.000 oseb: preobčutljivostne reakcije izpuščaj, koprivnica
English: Healthcare professionals are asked to report any suspected adverse reactions via [the national reporting system listed in Appendix V*].
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na [nacionalni center za poročanje, ki je naveden v Prilogi V*].
English: These amendments to the relevant sections of the Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Slovenian: Ta dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so nastala med napotitvenim postopkom.
English: A. Summary of Product Characteristics [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Slovenian: A. Povzetek glavnih značilnosti zdravila [Za vsa zdravila v Prilogi I se dopolnijo obstoječe informacije o zdravilu (besedilo se ustrezno vstavi, nadomesti ali izbriše) tako, da odražajo dogovorjeno besedilo, ki je navedeno spodaj]
English: B. Package Leaflet [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Slovenian: B. Navodilo za uporabo [Za vsa zdravila v Prilogi I se dopolnijo obstoječe informacije o zdravilu (besedilo se ustrezno vstavi, nadomesti ali izbriše) tako, da odražajo dogovorjeno besedilo, ki je navedeno spodaj]
English: There have been reports of severe skin reactions associated with the administration of <active substance>.
Slovenian: Poročali so, da so z dajanjem <zdravilna učinkovina> povezane hude kožne reakcije.
English: [The following warning should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Slovenian: [Za vsa zdravila, ki vsebujejo ambroksol in bromheksin, se mora v tem poglavju odraziti naslednje opozorilo]
English: Rare: rash, urticaria
Slovenian: Redki: izpuščaj, urtikarija
English: [The below paragraph should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Slovenian: [Za vsa zdravila, ki vsebujejo ambroksol in bromheksin, se mora v tem poglavju odraziti spodnji odstavek]
English: Not known: frequency cannot be estimated from the available data Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) and pruritus Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).
Slovenian: Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov anafilaktične reakcije, vključno z anafilaktičnim šokom, angioedemom (hitro otekanje kože, podkožnega, sluzničnega ali podsluzničnega tkiva) in srbenjem hude kožne neželene reakcije (vključno z multiformnim eritemom, Stevens-Johnsonovim sindromom/toksično epidermalno nekrolizo in akutno generalizirano eksantematozno pustulozo).
English: Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus Skin and subcutaneous tissue disorders
Slovenian: Neznana pogostnost: anafilaktične reakcije, vključno z anafilaktičnim šokom, angioedemom in pruritusom
English: Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Slovenian: Neznana pogostnost: hude kožne neželene reakcije (vključno z multiformnim eritemom, StevensJohnsonovim sindromom/toksično epidermalno nekrolizo in akutno generalizirano eksantematozno pustulozo).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Slovenian: Dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo
English: There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of <active substance>.
Slovenian: Poročali so, da so z dajanjem <zdravilna učinkovina> povezane hude kožne reakcije, kot so multiformni eritem, Stevens-Johnsonov sindrom (SJS)/toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantematozna pustuloza (AGEP).
English: [The following sub-heading should appear at the end of this section] Reporting of side effects
Slovenian: [Na koncu tega poglavja je treba vključiti naslednje podpoglavje]
English: Rash, urticaria
Slovenian: Bolezni kože in podkožja
English: • Your doctor will decide how many treatments you need.
Slovenian: • Zdravnik bo določil, koliko zdravljenj potrebujete.
English: Date of first authorisation: 21 September 2018
Slovenian: Datum prve odobritve: 21. september 2018
English: b (months)
Slovenian: b (meseci)
English: NR: Not Reached
Slovenian: ND: ni doseženo
English: However, a potential risk to the breast-fed child cannot be excluded.
Slovenian: Toda možnega tveganja za dojenega otroka ni mogoče izključiti.
English: • It is very important that you do not miss a dose of this medicine.
Slovenian: • Zelo pomembno je, da ne izpustite odmerka tega zdravila.
English: The analysis of OS was performed approximately 13 months after the primary analysis of PFS.
Slovenian: Analizo OS so izvedli približno 13 mesecev po primarni analizi PFS.
English: Steady state was achieved at approximately 16 weeks.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo po približno 16 tednih.
English: The presence of ADAs did not have a clinically relevant effect on safety.
Slovenian: Prisotnost ADAs ni klinično pomembno vplivala na varnost.
English: See Table 3 and Figures 1 and 2.
Slovenian: Glejte preglednico 3 in sliki 1 in 2.
English: This 1 patient received insulin.
Slovenian: Ta bolnik je prejemal insulin.
English: Dose escalation or reduction is not recommended.
Slovenian: Povečevanje ali zmanjševanje odmerka ni priporočljivo.
English: Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms.
Slovenian: Zdravnik lahko uporabi še druga zdravila, ki preprečujejo še hujše zaplete in za zmanjšanje vaših simptomov.
English: • you have an autoimmune disease (an illness where the body's immune system attacks its own cells);
Slovenian: • če imate kakšno avtoimunsko bolezen (bolezen, pri kateri telesni imunski sistem napada celice lastnega telesa);
English: Probability of PFS
Slovenian: Verjetnost PFS
English: Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje na področju zdravljenja raka.
English: The time to onset was 42 days.
Slovenian: Čas do pojava je bil 42 dni.
English: All Patients
Slovenian: Vsi bolniki
English: • has responded or stabilised after initial treatment with chemotherapy and radiotherapy.
Slovenian: • se je odzval ali stabiliziral po začetnem zdravljenju s kemoterapijo in obsevanjem.
English: Adrenal insufficiency
Slovenian: Adrenalna insuficienca
English: • Do not co-administer other medicinal products through the same infusion line.
Slovenian: • Tega zdravila ne dajajte skupaj z drugimi zdravili po isti infuzijski liniji.
English: If refrigerated, intravenous bags must be allowed to come to room temperature prior to use.
Slovenian: Če so intravenske vrečke shranjene v hladilniku, jih je treba pustiti, da pred uporabo dosežejo sobno temperaturo.
English: • The medicinal product, once diluted, should be used immediately.
Slovenian: • Ko je zdravilo razredčeno, ga je treba uporabiti takoj.
English: Patients with disease control at 12 months were given the option to be re-treated upon disease progression.
Slovenian: Bolniki, pri katerih je bila bolezen po 12 mesecih obvladana, so imeli možnost ponovnega zdravljenja po napredovanju bolezni.
English: PFS2 is defined as the time from the date of randomisation until the date of second progression (defined by local standard clinical practice) or death.
Slovenian: PFS2 je opredeljeno kot čas od datuma randomizacije do datuma drugega napredovanja bolezni (opredeljenega v okviru običajne lokalne klinične prakse) ali smrti.
English: ATC code: L01XC28
Slovenian: Oznaka ATC: L01XC28
English: In humans, antibodies may be transferred to breast milk, but the potential for absorption and harm to the newborn is unknown.
Slovenian: Pri človeku protitelesa lahko prehajajo v materino mleko, a možnost absorpcije in škode za novorojenčka ni znana.
English: PFS was assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.
Slovenian: PFS je bila ocenjena s slepljenim neodvisnim centralnim pregledom (BICR - “Blinded Independent Central Review”) v skladu z merili RECIST v1.1.
English: EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
Slovenian: EU/1/18/1322/002 120-mg viala EU/1/18/1322/001 500-mg viala
English: Common Terminology Criteria for Adverse Events, version 4.03.
Slovenian: Enotna razvrstitvi meril neželenih učinkov (“Common Terminology Criteria for Adverse Event”), različica 4.03.
English: The demographics and baseline disease characteristics were well balanced between study arms.
Slovenian: Demografske značilnosti in izhodiščne značilnosti bolezni so bile med študijskima skupinama dobro uravnotežene.
English: If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Slovenian: Če imate vprašanja o tem, kako deluje zdravilo IMFINZI ali zakaj ste ga dobili, vprašajte zdravnika ali farmacevta.
English: Fertility There are no data on the potential effects of durvalumab on fertility in humans or animals.
Slovenian: Plodnost Podatkov o možnih vplivih durvalumaba na plodnost pri človeku ali živalih ni.
English: <Other sources of information>
Slovenian: Drugi viri informacij
English: Any Grade (%)
Slovenian: Katera koli stopnja (%)
English: Carcinogenicity and mutagenicity The carcinogenic and genotoxic potential of durvalumab has not been evaluated.
Slovenian: Karcinogenost in mutagenost Karcinogenega in genotoksičnega potenciala durvalumaba niso ocenili.
English: Children and adolescents IMFINZI should not be used in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravila IMFINZI se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
Slovenian: Dati ga je treba kot raztopino za intravensko infundiranje v obdobju 60 minut (glejte poglavje 6.6).
English: • has spread within your lung and cannot be removed by surgery, and
Slovenian: • razširil v pljučih in ga ni mogoče odstraniti z operacijo in
English: Grade 3-4 (%)
Slovenian: 3.-4. stopnja (%)
English: The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila IMFINZI pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Slovenian: Končna koncentracija razredčene raztopine mora biti med 1 mg/ml in 15 mg/ml.
English: • painful urination
Slovenian: • boleče uriniranje
English: This includes herbal medicines and medicines obtained without a prescription.
Slovenian: To velja tudi za zeliščna zdravila in druga zdravila, ki ste jih dobili brez recepta.
English: Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker).
Slovenian: Randomizacija je bila stratificirana po spolu, starosti (< 65 let in ≥ 65 let) in kadilsko stanje (kadilci in nekadilci).
English: • Call your doctor straight away to reschedule your appointment.
Slovenian: • Takoj pokličite zdravnika, da se boste dogovorili za nov datum obiska.
English: There are insufficient number of patients to determine ADA impact on efficacy.
Slovenian: Število bolnikov je premajhno, da bi ugotovili, kakšen vpliv imajo ADA na učinkovitost.
English: If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy.
Slovenian: Če v 3 do 5 dneh kljub uporabi kortikosteroidov ne pride do izboljšanja, takoj začnite z dodatnim imunosupresivnim zdravljenjem.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI.
Slovenian: Večina teh, učinkov vključno s hudimi, je izzvenela po uvedbi ustreznega zdravljenja ali prenehanju uporabe zdravila IMFINZI.
English: IMFINZI (n = 476)
Slovenian: Zdravilo IMFINZI (n = 476)
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients.
Slovenian: Glede varnosti niso poročali o razlikah med starejšimi (starimi 65 let ali več) in mlajšimi bolniki v celoti.
English: The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Slovenian: Ustrezne kategorije pogostnosti za vsak neželeni učinek so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti na podlagi razpoložljivih podatkov).
English: • It is not known if IMFINZI passes into human breast milk.
Slovenian: • Ni znano, ali zdravilo IMFINZI prehaja v materino mleko.
English: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
Slovenian: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court Frederick,
English: Probability of OS
Slovenian: Verjetnost OS
English: In the absence of data, durvalumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Slovenian: Dokler takšnih podatkov ni, je treba durvalumab v teh skupinah bolnikov uporabljati previdno ter po skrbnem individualnem pretehtanju možnih koristi in tveganj za posameznega bolnika.
English: 6545CG Nijmegen, Netherlands
Slovenian: 6545CG Nijmegen, Nizozemska
English: What IMFINZI is and what it is used for
Slovenian: Kaj je zdravilo IMFINZI in za kaj ga uporabljamo
English: The terminal half-life (t1/2), based on baseline CL, was approximately 18 days.
Slovenian: Terminalni razpolovni čas (t1/2) na podlagi izhodiščnega očistka je bil približno 18 dni.
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti lastniško ime in številko serije uporabljenega zdravila.
English: • you have had an organ transplant;
Slovenian: • če imate kakšen presajen organ;
English: However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
Slovenian: Toda če imate neželene učinke, ki vam poslabšajo sposobnost za zbranost in reagiranje, morate biti pri upravljanju vozil in strojev previdni.
English: Do not store any unused portion of the infusion solution for re-use.
Slovenian: Morebitnega neporabljenega dela raztopine za infundiranje ne shranjujte za ponovno uporabo.
English: IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Slovenian: Zdravilo IMFINZI boste dobili v bolnišnici ali ambulanti pod nadzorstvom izkušenega zdravnika.
English: Tumour assessments were conducted every 8 weeks for the first 12 months and then every 12 weeks thereafter.
Slovenian: Ocenjevanje tumorja so izvajali na 8 tednov prvih 12 mesecev, nato pa na 12 tednov.