FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis.
Slovenian: V primeru nefritisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
English: Myasthenia Gravis) - Immune-Related Meningoencephalitis - Immune-Related Myocarditis - Immune-Related Nephritis - Immune-Related Myositis - Infusion-Related Reactions
Slovenian: - imunsko pogojeni hepatitis - imunsko pogojeni pnevmonitis - imunsko pogojeni kolitis - imunsko pogojeni pankreatitis - imunsko pogojene endokrinopatije (sladkorna bolezen tipa 1, hipotiroidizem,
English: 9.3, 40.0) in patients with PD-L1 expression ≥ 5%, 18.8% (95% CI: 10.9, 29.0) in patients with PD-L1 expression ≥ 1%, and 19.3% (95% CI: 12.7, 27.6) in all comers.
Slovenian: Potrjeni delež objektivnega odgovora s strani IRF po merilih RECIST v1.1 so bili 21,9 % (95-% IZ: 9,3; 40,0) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 18,8 % (95-% IZ: 10,9; 29,0) pri bolnikih z izražanjem PD-L1 ≥ 1 % in 19,3 % (95-% IZ: 12,7; 27,6) pri neselekcioniranih bolnikih.
English: Disease-specific precautions
Slovenian: Previdnostni ukrepi, povezani z boleznijo
English: Atezolizumab (1,200 mg)a + nab-paclitaxel (100 mg/m2)b,c
Slovenian: A atezolizumab (1200 mg)a + karboplatin (AUC 5)b + etopozid (100 mg/m2)b,c atezolizumab (1200 mg)a
English: For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15.
Slovenian: V vsakem 28-dnevnem ciklu se zdravilo Tecentriq uporabi 1. in 15. dan, nabpaklitaksel pa 1., 8. in 15. dan. Glejte tudi celotne informacije za predpisovanje zdravila, ki se uporablja v kombinaciji (glejte tudi poglavje 5.1).
English: Arm B in the ITT population (IMpower150)
Slovenian: Povzetek posodobljenih podatkov o učinkovitosti za skupino A v primerjavi s skupino B v populaciji ITT (IMpower150)
English: Cases of myositis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Slovenian: V kliničnih preskušanjih z atezolizumabom so opazili primere miozitisa, vključno s smrtnimi primeri (glejte poglavje 4.8).
English: • The Guide for healthcare professionals shall contain the following key elements: Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Tecentriq: - Immune-Related Hepatitis - Immune-Related Pneumonitis - Immune-Related Colitis - Immune-Related Pancreatitis - Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism,
Slovenian: Ustrezne informacije (npr. resnost, izrazitost, pogostnost, čas do pojava, reverzibilnost, kot je ustrezno) o naslednjih varnostnih tveganjih, povezanih z uporabo zdravila
English: Includes reports of thrombocytopenia and platelet count decreased.
Slovenian: Vključuje poročila o trombocitopeniji in zmanjšanju števila trombocitov.
English: Primary efficacy endpoint OS
Slovenian: Primarni opazovani dogodek učinkovitosti
English: Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy.
Slovenian: Imunsko pogojene nevropatije Guillain-Barréjev sindrom in demielinizacijske polinevropatije so se pojavili pri 0,2 % (5/3178)
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
Slovenian: V primeru diareje 2. ali 3. stopnje (povečanje za ≥ 4 iztrebljanja na dan v primerjavi z izhodiščem) ali (simptomatskega) kolitisa je treba zdravljenje z atezolizumabom odložiti.
English: Patients should be monitored for signs and symptoms of colitis.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov kolitisa.
English: ǂStratified by PD-L1 expression in tumour infiltrating immune cells, the number of prior chemotherapy regimens, and histology ** Based on the stratified log-rank test *** Based on Kaplan-Meier estimates
Slovenian: ǂStratificirani glede na ekspresijo PD-L1 na celicah imunskega sistema, ki infiltrirajo tumor, glede na število predhodnih shem kemoterapije in glede na histologijo
English: No. of stable disease Investigator-assessed DOR
Slovenian: Število stabilne bolezni
English: If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Slovenian: Če se neželeni učinek izboljša na ≤ 1. stopnjo, je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 myositis and corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) should be initiated.
Slovenian: V primeru miozitisa 2. ali 3. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
English: Patients with liver metastases did not show improved PFS or OS with atezolizumab, nab-paclitaxel and carboplatin, compared to nab-paclitaxel and carboplatin (HR of 0.93, 95% CI: 0.59, 1.47 for PFS and HR of 1.04,
Slovenian: nab-paklitakselom in karboplatinom v primerjavi z nab-paklitakselom in karboplatinom (RO 0,93, 95
English: The physician educational material should contain:
Slovenian: • Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: A phase III, open-label, multi-center, international, randomised study, OAK, was conducted to evaluate the efficacy and safety of atezolizumab compared with docetaxel in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen.
Slovenian: Za oceno učinkovitosti in varnosti atezolizumaba v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki jim je bolezen napredovala med shemo zdravljenja na osnovi platine ali po takšnem zdravljenju, so izvedli multicentrično, mednarodno, odprto randomizirano študijo faze III (OAK).
English: Symptomatic Colitis
Slovenian: ali simptomatski kolitis
English: or
Slovenian: y
English: Colitis
Slovenian: VIALA
English: CI = confidence interval; DOR = duration of response; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Slovenian: PFS (progression-free survival) = preživetje brez napredovanja bolezni; RECIST (Response Evaluation Criteria in Solid Tumours) v1.1 = merila RECIST; IZ = interval zaupanja; ORR (objective response rate) = delež objektivnega odgovora; DOR (duration of response) = trajanje odgovora; OS (overall survival) = celokupno preživetje.
English: Withhold until adverse reactions recovers to Grade 0-1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Slovenian: Odložite uporabo zdravila, dokler se neželeni učinek v 12 tednih ne izboljša na 0. do 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
English: The observed OS improvement was consistently demonstrated across subgroups of patients including those with brain metastases at baseline (HR of 0.54, 95% CI: 0.31, 0.94; median OS of 20.1
Slovenian: Opaženo izboljšanje celokupnega preživetja je bilo dosledno dokazano v podskupinah bolnikov, vključno z bolniki, ki so izhodiščno imeli zasevke v možganih (RO 0,54; 95-% IZ: 0,31; 0,94; mediano celokupno preživetje 20,1 meseca z atezolizumabom in 11,9 meseca z docetakselom), in bolniki, ki nikoli niso kadili (RO 0,71; 95-% IZ: 0,47; 1,08; mediano celokupno preživetje 16,3 meseca z atezolizumabom in 12,6 meseca z docetakselom).
English: The median time to onset was 7 months (range: 18 days to
Slovenian: Mediani čas do pojava je bil 7 mesecev (razpon: od 18 dni do 8,1 meseca).
English: MARKETING AUTHORISATION HOLDER Roche Registration GmbH Emil-Barell-Strasse 1
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: No. of responders (%) 95% CI
Slovenian: Št. bolnikov z odgovorom (%) 95-% IZ
English: Cases of diarrhoea or colitis have been observed in clinical trials with atezolizumab (see section 4.8).
Slovenian: V kliničnih preskušanjih atezolizumaba so opažali primere diareje ali kolitisa (glejte poglavje 4.8).
English: Nausea, diarrhoea, stomatitis, fatigue, pyrexia, mucosal inflammation, decreased appetite, weight decreased, hypertension and proteinuria were reported higher (≥5% difference) in patients receiving atezolizumab in combination with bevacizumab,
Slovenian: Pri bolnikih, ki so prejemali atezolizumab v kombinaciji z bevacizumabom, paklitakselom in karboplatinom, so pogosteje (z ≥ 5-% razliko) poročali o slabosti, diareji, stomatitisu, utrujenosti, zvišani telesni temperaturi, vnetju sluznice, zmanjšanem apetitu, zmanjšanju telesne mase, hipertenziji in proteinuriji.
English: Secondary endpoints Investigator-assessed PFS (RECIST v1.1)
Slovenian: 12-mesečno OS (%) PFS po oceni raziskovalca (RECIST v1.1)
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Slovenian: Zdravljenje z atezolizumabom se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
English: Tel: +49 (0) 7624 140
Slovenian: Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
English: Tel: +43 (0) 1 27739
Slovenian: Roche Austria GmbH Tel: +43 (0) 1 27739
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg oral prednisone or equivalent per day.
Slovenian: Zdravljenje z atezolizumabom se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo, odmerek kortikosteroidov pa je zmanjšan na ≤ 10 mg peroralnega prednizona na dan (ali ekvivalenta).
English: Uncommon hyperthyroidismh, diabetes mellitusi, adrenal insufficiencyj
Slovenian: Bolezni endokrinega sistema zelo pogosti hipotiroidizemg pogosti hipotiroidizemg občasni hipertiroidizemh, sladkorna bolezeni, insuficienca nadledvičnih žlezj redki hipofizitisk
English: Nab-paclitaxel (100 mg/m2)b,c + carboplatin (AUC 6)c
Slovenian: bevacizumabd (15 mg/kg) + paklitaksel 2)b,c + karboplatinc (AUC 6) (200 mg/m bevacizumabd (15 mg/kg)
English: The median time to onset was 5.0 months (range: 9 days to
Slovenian: Mediani čas do pojava je bil 5,0 meseca (razpon: od 9 dni do 16,9 meseca).
English: Treatment may be resumed if the event improves to ≤ Grade 1 within
Slovenian: Zdravljenje z atezolizumabom se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo,
English: This means the lung cancer has: spread to other parts of the body come back after previous treatment.
Slovenian: To pomeni, da: se je razširil v druge dele telesa,
English: s Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative.
Slovenian: s Vključuje poročila o kolitisu, avtoimunskem kolitisu, ishemičnem kolitisu, mikroskopskem kolitisu,
English: Efficacy endpoint
Slovenian: Opazovani dogodek učinkovitosti
English: months).
Slovenian: 9 tednov.
English: Therefore, its use in this age group is not relevant.
Slovenian: Zato njegova uporaba v tej starostni skupini ni primerna.
English: • Use of antibiotics according to national guidelines
Slovenian: • uporaba antibiotikov v skladu z nacionalnimi smernicami
English: Absorption / Distribution
Slovenian: Absorpcija/porazdelitev
English: No special considerations are needed.
Slovenian: Posebna obravnava ni potrebna.
English: These may be serious and require that you contact your doctor immediately.
Slovenian: Te so lahko resne, zato je potrebno, da se takoj posvetujete z zdravnikom.
English: It is important to have any symptoms diagnosed and treated as soon as possible.
Slovenian: Pomembno je, da se simptomi čim prej ugotovijo in zdravijo.
English: A risk to the breast-fed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka se ne da izključiti.
English: Therefore, systemic pharmacodynamic effects such as blood pressure changes are unlikely.
Slovenian: Zato sistemski farmakodinamični učinki, kot so spremembe krvnega tlaka, niso verjetni.
English: Recurrences should be treated as a new manifestation of the disease.
Slovenian: Ponovitve bolezni je treba zdraviti kot nov pojav bolezni.
English: This benefit was maintained through week 100.
Slovenian: Koristi so se ohranile do 100. tedna.
English: • When to seek urgent attention from their health care provider
Slovenian: • kdaj poiskati nujno medicinsko pomoč pri zdravstvenem osebju
English: 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)
Slovenian: 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).
English: LOCF: Last Observation Carried Forward
Slovenian: LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward)
English: You will receive further injections only if your doctor's examinations reveal that your condition has not improved.
Slovenian: Dodatne injekcije boste prejeli samo, če bodo preiskave, ki jih bo opravil zdravnik, pokazale, da se stanje ni izboljšalo.
English: Patients should not drive or use machines until their visual function has recovered sufficiently.
Slovenian: Bolniki ne smejo voziti ali upravljati strojev, dokler se jim vid dovolj ne izboljša.
English: Please do not get alarmed, you might not experience any of these.
Slovenian: Ni razloga za zaskrbljenost, morda se vam ne bo pojavil nobeden od njih.
English: Allergic reactions (hypersensitivity) could potentially occur.
Slovenian: Lahko se pojavijo alergijske reakcije (preobčutljivost).
English: The statistically significant difference was maintained through week 52.
Slovenian: Statistično značilna razlika se je ohranila do 52. tedna.
English: Among those, 2,501 patients were treated with the recommended dose of 2 mg.
Slovenian: Od teh bolnikov jih je bilo 2.501 zdravljenih s priporočenim odmerkom 2 mg.
English: SD: Standard deviation
Slovenian: SD: standardna deviacija (Standard deviation)
English: No studies have been conducted on the mutagenic or carcinogenic potential of aflibercept.
Slovenian: Študij za ugotavljanje mutagenega ali kancerogenega potenciala aflibercepta niso izvedli.
English: From this timepoint all patients were treated if prespecified criteria were met.
Slovenian: Od tedaj so zdravili vse bolnike, ki so izpolnjevali vnaprej določene kriterije.
English: 2mgE)
Slovenian: 2 mg
English: The physician information in the educational material contains the following key elements:
Slovenian: Informacije za zdravnike v izobraževalnem gradivu morajo vsebovati naslednja ključna sporočila:
English: The majority of patients in both studies had Type II diabetes.
Slovenian: V obeh študijah je imela večina bolnikov sladkorno bolezen tipa II.
English: These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies.
Slovenian: Ti resni neželeni učinki, ki prizadenejo oko, so se v kliničnih študijah pojavili pri manj kot 1 od 1.900 injekcij.
English: Hypersensitivity***
Slovenian: Bolezni imunskega sistema preobčutljivost***
English: Over the 2 year treatment period patients received an average of 10.4 injections.
Slovenian: V 2-letnem obdobju zdravljenja so bolniki prejeli povprečno 10,4 injekcij.
English: * Conditions known to be associated with wet AMD.
Slovenian: * Stanja, za katera je znano, da so povezana z vlažno AMD.
English: Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity.
Slovenian: Mesečno zdravljenje se nadaljuje, dokler ni dosežena največja ostrina vida in/ali ni znakov napredovanja bolezni.
English: There are no data on the use of aflibercept in pregnant women.
Slovenian: Podatkov o uporabi aflibercepta pri nosečnicah ni.
English: Date of latest renewal: 13 July 2017
Slovenian: Datum prve odobritve: 22. november 2012 Datum zadnjega podaljšanja: 13. julij 2017
English: As with other large proteins, both free and bound aflibercept are expected to be cleared by proteolytic catabolism.
Slovenian: Kot pri drugih velikih proteinih je pričakovati, da se prosti in vezani aflibercept izločita s proteolitičnim katabolizmom.
English: Observed in the wet AMD studies only.
Slovenian: Opazili so jih samo v študijah vlažne AMD.
English: Differences for both endpoints were maintained through week 48.
Slovenian: Razlika za oba končna cilja se je ohranila do 48. tedna.
English: Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Slovenian: Dobili boste tudi lokalni anestetik za zmanjšanje oziroma preprečitev morebitne bolečine zaradi injekcije.
English: If required, sterile equipment for paracentesis should be available.
Slovenian: Vedno naj bo na voljo sterilna oprema, če bi bila potrebna paracenteza.
English: Remove the filter needle and properly dispose of it.
Slovenian: Filtrirno iglo odstranite in jo pravilno zavrzite.
English: Ocular and systemic safety profiles were similar to the safety observed in the pivotal studies VIEW1 and VIEW2.
Slovenian: Okularni in sistemski profil varnosti sta bila podobna varnostnemu profilu, ugotovljenem v ključnih študijah VIEW1 in VIEW2.
English: At week 24 these proportions were 80% and 67%, respectively.
Slovenian: V 24. tednu je bil ta delež 80 % oziroma 67 %.
English: Populations with limited data
Slovenian: Populacije za katere je na voljo malo podatkov
English: Aflibercept does not accumulate in the plasma when administered intravitreally every 4 weeks.
Slovenian: Aflibercept se v plazmi ne kopiči, če se aplicira intravitrealno vsake 4 tedne.
English: The safety and efficacy of Eylea have not been established in children and adolescents.
Slovenian: Varnost in učinkovitost zdravila Eylea pri otrocih in mladostnikih nista bili dokazani.
English: If your condition worsens, the interval between injections can be shortened, but to not less than every two months in the first year of treatment.
Slovenian: Če se vaše stanje poslabša, se lahko interval med injekcijami skrajša, vendar ne na manj kot vsaka dva meseca v prvem letu zdravljenja.
English: - the safety and efficacy of Eylea when administered to both eyes at the same time has not been studied and if used in this way may lead to an increased risk of experiencing side effects.
Slovenian: - Varnosti in učinkovitosti zdravila Eylea pri sočasnem dajanju v obe očesi hkrati niso preučevali in če se uporablja na ta način lahko privede do povečanega tveganja za pojav neželenih učinkov.
English: PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes.
Slovenian: PlGF se veže samo na VEGFR-1, ki je prisoten tudi na površini levkocitov.
English: Following this, patients in both groups continued to be eligible for additional injections in case of disease persistence or recurrence.
Slovenian: Nato so bolniki v obeh skupinah prejeli dodatne injekcije, če je bolezen vztrajala ali se ponovila.
English: Make a new appointment for an examination and injection.
Slovenian: Dogovorite se za novi datum pregleda in injiciranje zdravila.
English: The interval between two injections should not be shorter than one month.
Slovenian: Interval med dvema injekcijama ne sme biti krajši od enega meseca.
English: If you are pregnant or planning to become pregnant, discuss this with your doctor before treatment with Eylea.
Slovenian: Če ste noseči ali načrtujete nosečnost, se posvetujte z zdravnikom, preden se začnete zdraviti z zdravilom Eylea.
English: In addition, the mean CNV lesion size decreased.
Slovenian: Dodatno se je zmanjšala povprečna velikost CNV lezije.
English: An independent comparative trial (DRCR.net Protocol T) utilised a dosing regimen based on strict OCT and vision re-treatment criteria.
Slovenian: V neodvisnem primerjalnem preskušanju (DRCR.net Protocol T) so uporabljali režim odmerjanja na osnovi natančne OCT in kriterijev za ponovno zdravljenje vida.
English: • The safety and efficacy of Eylea therapy administered to both eyes concurrently have not been systematically studied (see section 5.1).
Slovenian: • Varnosti in učinkovitosti zdravljenja z zdravilom Eylea, sočasno apliciranim v obe očesi, niso sistematično preučevali (glejte poglavje 5.1).
English: Furthermore, it is important for you to know that:
Slovenian: Za vas so pomembni tudi naslednji podatki:
English: Your treatment will continue with monthly injections until your condition is stable.
Slovenian: Zdravljenje z eno injekcijo na mesec se bo nadaljevalo, dokler bo vaše stanje stabilno.
English: What Eylea is and what it is used for
Slovenian: Kaj je zdravilo Eylea in za kaj ga uporabljamo
English: A doctor experienced in giving eye injections will inject Eylea into your eye under aseptic (clean and sterile) conditions.
Slovenian: Zdravnik, ki ima izkušnje z dajanjem injekcij v oko, vam bo injiciral zdravilo Eylea v oko v aseptičnih (čistih in sterilnih) pogojih.
English: Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments.
Slovenian: Glede na vaš odziv na zdravljenje, bo zdravnik določil načrt nadaljnih pregledov in zdravljenja.
English: Important information about some of the ingredients of Eylea This medicine contains less than 1 mmol (23 mg) of sodium per dose which means it is essentially “sodium-free”.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Eylea To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Slovenian: Spremljanje napredovanja bolezni lahko vključuje klinični pregled, funkcijske preiskave in slikovne metode (npr. optična koherentna tomografija ali fluoresceinska angiografija).
English: Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections.
Slovenian: Če nimate težav ali vam zdravnik ni drugače svetoval, zdravniški pregledi med injekcijami niso potrebni.
English: Before the injection your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection.
Slovenian: Pred injiciranjem vam bo zdravnik previdno očistil oko z razkužilom, da se prepreči okužba.
English: There is a theoretical risk of such events following injection of Eylea into the eye.
Slovenian: Teoretično obstaja tveganje, da se taki dogodki pojavijo po injiciranju zdravila Eylea v oko.
English: In patients presenting with clinical signs of irreversible ischaemic visual function loss, the treatment is not recommended.
Slovenian: Pri bolnikih s kliničnimi znaki ireverzibilne izgube vidne funkcije zaradi ishemije se zdravljenja ne priporoča.
English: If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Slovenian: Če poteka zdravljenje istočasno na obeh očesih, to lahko privede do povečane sistemske izpostavljenosti, ki lahko poveča tveganje za sistemske neželene učinke.
English: Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Slovenian: Sočasne uporabe fotodinamičnega zdravljenja (PDT - Photodynamic Therapy) z verteporfinom in zdravila Eylea niso preučevali, zato varnostni profil ni dokazan.
English: Your doctor will determine the most appropriate treatment schedule for you.
Slovenian: Zdravnik vam bo določil načrt zdravljenja, ki je za vas najbolj primeren.
English: A positive value favours Eylea.
Slovenian: Pozitivna vrednost je v korist zdravila Eylea.
English: The treatment interval is then extended to two months.
Slovenian: Interval med posameznimi odmerki se nato podaljša na dva meseca.
English: If your condition goes away and then comes back, your doctor may re-start the treatment.
Slovenian: Če se bolezen pozdravi in se nato ponovi, lahko zdravnik ponovno začne zdravljenje.
English: Nominal p-value
Slovenian: Nominalna vrednost p