natgillin/translations-raw huggingface dataset:
Colitis
VIALA
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.
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.
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.
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.
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
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).
The median time to onset was 7 months (range: 18 days to
Mediani čas do pojava je bil 7 mesecev (razpon: od 18 dni do 8,1 meseca).
MARKETING AUTHORISATION HOLDER Roche Registration GmbH Emil-Barell-Strasse 1
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
No. of responders (%) 95% CI
Št. bolnikov z odgovorom (%) 95-% IZ
Cases of diarrhoea or colitis have been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih atezolizumaba so opažali primere diareje ali kolitisa (glejte poglavje 4.8).
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,
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.
Secondary endpoints Investigator-assessed PFS (RECIST v1.1)
12-mesečno OS (%) PFS po oceni raziskovalca (RECIST v1.1)
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.
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.
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.
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).
Uncommon hyperthyroidismh, diabetes mellitusi, adrenal insufficiencyj
Bolezni endokrinega sistema zelo pogosti hipotiroidizemg pogosti hipotiroidizemg občasni hipertiroidizemh, sladkorna bolezeni, insuficienca nadledvičnih žlezj redki hipofizitisk
Nab-paclitaxel (100 mg/m2)b,c + carboplatin (AUC 6)c
bevacizumabd (15 mg/kg) + paklitaksel 2)b,c + karboplatinc (AUC 6) (200 mg/m bevacizumabd (15 mg/kg)
The median time to onset was 5.0 months (range: 9 days to
Mediani čas do pojava je bil 5,0 meseca (razpon: od 9 dni do 16,9 meseca).
Treatment may be resumed if the event improves to ≤ Grade 1 within
Zdravljenje z atezolizumabom se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo,
This means the lung cancer has: spread to other parts of the body come back after previous treatment.
To pomeni, da: se je razširil v druge dele telesa,
s Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative.
s Vključuje poročila o kolitisu, avtoimunskem kolitisu, ishemičnem kolitisu, mikroskopskem kolitisu,
Efficacy endpoint
Opazovani dogodek učinkovitosti
months).
9 tednov.
Therefore, its use in this age group is not relevant.
Zato njegova uporaba v tej starostni skupini ni primerna.
• Use of antibiotics according to national guidelines
• uporaba antibiotikov v skladu z nacionalnimi smernicami
Absorption / Distribution
Absorpcija/porazdelitev
No special considerations are needed.
Posebna obravnava ni potrebna.
These may be serious and require that you contact your doctor immediately.
Te so lahko resne, zato je potrebno, da se takoj posvetujete z zdravnikom.
It is important to have any symptoms diagnosed and treated as soon as possible.
Pomembno je, da se simptomi čim prej ugotovijo in zdravijo.
A risk to the breast-fed child cannot be excluded.
Tveganja za dojenega otroka se ne da izključiti.
Therefore, systemic pharmacodynamic effects such as blood pressure changes are unlikely.
Zato sistemski farmakodinamični učinki, kot so spremembe krvnega tlaka, niso verjetni.
Recurrences should be treated as a new manifestation of the disease.
Ponovitve bolezni je treba zdraviti kot nov pojav bolezni.
This benefit was maintained through week 100.
Koristi so se ohranile do 100. tedna.
• When to seek urgent attention from their health care provider
• kdaj poiskati nujno medicinsko pomoč pri zdravstvenem osebju
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)
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).
LOCF: Last Observation Carried Forward
LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward)
You will receive further injections only if your doctor's examinations reveal that your condition has not improved.
Dodatne injekcije boste prejeli samo, če bodo preiskave, ki jih bo opravil zdravnik, pokazale, da se stanje ni izboljšalo.
Patients should not drive or use machines until their visual function has recovered sufficiently.
Bolniki ne smejo voziti ali upravljati strojev, dokler se jim vid dovolj ne izboljša.
Please do not get alarmed, you might not experience any of these.
Ni razloga za zaskrbljenost, morda se vam ne bo pojavil nobeden od njih.
Allergic reactions (hypersensitivity) could potentially occur.
Lahko se pojavijo alergijske reakcije (preobčutljivost).
The statistically significant difference was maintained through week 52.
Statistično značilna razlika se je ohranila do 52. tedna.
Among those, 2,501 patients were treated with the recommended dose of 2 mg.
Od teh bolnikov jih je bilo 2.501 zdravljenih s priporočenim odmerkom 2 mg.
SD: Standard deviation
SD: standardna deviacija (Standard deviation)
No studies have been conducted on the mutagenic or carcinogenic potential of aflibercept.
Študij za ugotavljanje mutagenega ali kancerogenega potenciala aflibercepta niso izvedli.
From this timepoint all patients were treated if prespecified criteria were met.
Od tedaj so zdravili vse bolnike, ki so izpolnjevali vnaprej določene kriterije.
2mgE)
2 mg
The physician information in the educational material contains the following key elements:
Informacije za zdravnike v izobraževalnem gradivu morajo vsebovati naslednja ključna sporočila:
The majority of patients in both studies had Type II diabetes.
V obeh študijah je imela večina bolnikov sladkorno bolezen tipa II.
These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies.
Ti resni neželeni učinki, ki prizadenejo oko, so se v kliničnih študijah pojavili pri manj kot 1 od 1.900 injekcij.
Hypersensitivity***
Bolezni imunskega sistema preobčutljivost***
Over the 2 year treatment period patients received an average of 10.4 injections.
V 2-letnem obdobju zdravljenja so bolniki prejeli povprečno 10,4 injekcij.
* Conditions known to be associated with wet AMD.
* Stanja, za katera je znano, da so povezana z vlažno AMD.
Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity.
Mesečno zdravljenje se nadaljuje, dokler ni dosežena največja ostrina vida in/ali ni znakov napredovanja bolezni.
There are no data on the use of aflibercept in pregnant women.
Podatkov o uporabi aflibercepta pri nosečnicah ni.
Date of latest renewal: 13 July 2017
Datum prve odobritve: 22. november 2012 Datum zadnjega podaljšanja: 13. julij 2017
As with other large proteins, both free and bound aflibercept are expected to be cleared by proteolytic catabolism.
Kot pri drugih velikih proteinih je pričakovati, da se prosti in vezani aflibercept izločita s proteolitičnim katabolizmom.
Observed in the wet AMD studies only.
Opazili so jih samo v študijah vlažne AMD.
Differences for both endpoints were maintained through week 48.
Razlika za oba končna cilja se je ohranila do 48. tedna.
Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Dobili boste tudi lokalni anestetik za zmanjšanje oziroma preprečitev morebitne bolečine zaradi injekcije.
If required, sterile equipment for paracentesis should be available.
Vedno naj bo na voljo sterilna oprema, če bi bila potrebna paracenteza.
Remove the filter needle and properly dispose of it.
Filtrirno iglo odstranite in jo pravilno zavrzite.
Ocular and systemic safety profiles were similar to the safety observed in the pivotal studies VIEW1 and VIEW2.
Okularni in sistemski profil varnosti sta bila podobna varnostnemu profilu, ugotovljenem v ključnih študijah VIEW1 in VIEW2.
At week 24 these proportions were 80% and 67%, respectively.
V 24. tednu je bil ta delež 80 % oziroma 67 %.
Populations with limited data
Populacije za katere je na voljo malo podatkov
Aflibercept does not accumulate in the plasma when administered intravitreally every 4 weeks.
Aflibercept se v plazmi ne kopiči, če se aplicira intravitrealno vsake 4 tedne.
The safety and efficacy of Eylea have not been established in children and adolescents.
Varnost in učinkovitost zdravila Eylea pri otrocih in mladostnikih nista bili dokazani.
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.
Če se vaše stanje poslabša, se lahko interval med injekcijami skrajša, vendar ne na manj kot vsaka dva meseca v prvem letu zdravljenja.
- 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.
- 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.
PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes.
PlGF se veže samo na VEGFR-1, ki je prisoten tudi na površini levkocitov.
Following this, patients in both groups continued to be eligible for additional injections in case of disease persistence or recurrence.
Nato so bolniki v obeh skupinah prejeli dodatne injekcije, če je bolezen vztrajala ali se ponovila.
Make a new appointment for an examination and injection.
Dogovorite se za novi datum pregleda in injiciranje zdravila.
The interval between two injections should not be shorter than one month.
Interval med dvema injekcijama ne sme biti krajši od enega meseca.
If you are pregnant or planning to become pregnant, discuss this with your doctor before treatment with Eylea.
Če ste noseči ali načrtujete nosečnost, se posvetujte z zdravnikom, preden se začnete zdraviti z zdravilom Eylea.
In addition, the mean CNV lesion size decreased.
Dodatno se je zmanjšala povprečna velikost CNV lezije.
An independent comparative trial (DRCR.net Protocol T) utilised a dosing regimen based on strict OCT and vision re-treatment criteria.
V neodvisnem primerjalnem preskušanju (DRCR.net Protocol T) so uporabljali režim odmerjanja na osnovi natančne OCT in kriterijev za ponovno zdravljenje vida.
• The safety and efficacy of Eylea therapy administered to both eyes concurrently have not been systematically studied (see section 5.1).
• Varnosti in učinkovitosti zdravljenja z zdravilom Eylea, sočasno apliciranim v obe očesi, niso sistematično preučevali (glejte poglavje 5.1).
Furthermore, it is important for you to know that:
Za vas so pomembni tudi naslednji podatki:
Your treatment will continue with monthly injections until your condition is stable.
Zdravljenje z eno injekcijo na mesec se bo nadaljevalo, dokler bo vaše stanje stabilno.
What Eylea is and what it is used for
Kaj je zdravilo Eylea in za kaj ga uporabljamo
A doctor experienced in giving eye injections will inject Eylea into your eye under aseptic (clean and sterile) conditions.
Zdravnik, ki ima izkušnje z dajanjem injekcij v oko, vam bo injiciral zdravilo Eylea v oko v aseptičnih (čistih in sterilnih) pogojih.
Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments.
Glede na vaš odziv na zdravljenje, bo zdravnik določil načrt nadaljnih pregledov in zdravljenja.
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”.
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'.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Spremljanje napredovanja bolezni lahko vključuje klinični pregled, funkcijske preiskave in slikovne metode (npr. optična koherentna tomografija ali fluoresceinska angiografija).
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.
Če nimate težav ali vam zdravnik ni drugače svetoval, zdravniški pregledi med injekcijami niso potrebni.
Before the injection your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection.
Pred injiciranjem vam bo zdravnik previdno očistil oko z razkužilom, da se prepreči okužba.
There is a theoretical risk of such events following injection of Eylea into the eye.
Teoretično obstaja tveganje, da se taki dogodki pojavijo po injiciranju zdravila Eylea v oko.
In patients presenting with clinical signs of irreversible ischaemic visual function loss, the treatment is not recommended.
Pri bolnikih s kliničnimi znaki ireverzibilne izgube vidne funkcije zaradi ishemije se zdravljenja ne priporoča.
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.
Če poteka zdravljenje istočasno na obeh očesih, to lahko privede do povečane sistemske izpostavljenosti, ki lahko poveča tveganje za sistemske neželene učinke.
Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Sočasne uporabe fotodinamičnega zdravljenja (PDT - Photodynamic Therapy) z verteporfinom in zdravila Eylea niso preučevali, zato varnostni profil ni dokazan.
Your doctor will determine the most appropriate treatment schedule for you.
Zdravnik vam bo določil načrt zdravljenja, ki je za vas najbolj primeren.
A positive value favours Eylea.
Pozitivna vrednost je v korist zdravila Eylea.
The treatment interval is then extended to two months.
Interval med posameznimi odmerki se nato podaljša na dva meseca.
If your condition goes away and then comes back, your doctor may re-start the treatment.
Če se bolezen pozdravi in se nato ponovi, lahko zdravnik ponovno začne zdravljenje.
Nominal p-value
Nominalna vrednost p
PlGF can synergize with VEGFA in these processes, and is also known to promote leucocyte infiltration and vascular inflammation.
PlGF lahko v teh procesih deluje sinergično z VEGF-A, znano pa je tudi, da pospešuje infiltracijo levkocitov in vnetje žil.
Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Prekomerna aktivacija teh receptorjev z VEGF-A lahko povzroči patološko neovaskularizacijo in prekomerno žilno prepustnost.
Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino aflibercept ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Confirmation that the vial is for single use only
• poudarek, da je viala samo za enkratno uporabo
Additionally, region (Europe/Australia vs. Japan) had been included as factor for VIVIDDME, and history of MI and/or CVA as a factor for VISTADME.
Dodatno je bila vključena regija (Evropa/Avstralija v primerjavi z Japonsko) kot dejavnik za študijo VIVIDDME in anamneza MI in/ali CVA kot dejavnik za študijo VISTADME.
For handling of the medicinal product before administration, see section 6.6.
Za navodila glede ravnanja z zdravilom pred uporabo glejte poglavje 6.6.
Special precaution is needed in patients with poorly controlled glaucoma (do not inject Eylea while the intraocular pressure is ≥ 30 mmHg).
Posebna previdnost je potrebna pri bolnikih z neustrezno zdravljenim glavkomom (zdravila Eylea ne injicirajte, če je intraokularni tlak ≥ 30 mmHg).
The reduction of CNV size and reduction in CRT were generally maintained in the second year of the studies.
Zmanjšana CNV in zmanjšana CRT sta bili običajno ohranjeni tudi v drugem letu študij.
A total of 3,102 patients constituted the safety population in the eight phase III studies.
V osmih študijah III. faze je bilo v populacijo za oceno varnosti zdravila vključenih skupaj 3.102 bolnikov.
Active or suspected ocular or periocular infection.
Aktivna okužba očesa ali periokularna okužba ali sum nanjo.
Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
Pri indikacijah niso opazili razlik med skupinami, zdravljenimi z afliberceptom in primerjalno skupino.
At total of 67 subjects in this group received Eylea rescue treatment.
Skupno 67 bolnikov v tej skupini je prejelo rešilno zdravljenje z zdravilom Eylea.
The monitoring and treatment schedule should be determined by the treating physician based on the individual patient's response.
Načrt spremljanja in zdravljenja bolnika mora določiti lečeči zdravnik in sicer glede na odziv posameznega bolnika na zdravljenje.
Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Bolnike je treba poučiti, da takoj poročajo o vseh simptomih, ki bi lahko kazali na endoftalmitis ali če se pojavi kateri koli od zgoraj omenjenih dogodkov.
Such effects are not expected after ocular administration with very low systemic exposure.
Taki učinki niso pričakovani po okularni uporabi, kjer je sistemska izpostavljenost zelo majhna.
Available data do not suggest a need for a dose adjustment with Eylea in these patients (see section 5.2).
Glede na razpoložljive podatke odmerka zdravila Eylea pri teh bolnikih ni treba prilagajati (glejte poglavje 5.2).
The difference between treatment groups was statistically significant in favour of Eylea in both studies.
Razlika med zdravljenima skupinama je bila v obeh študijah statistično značilna v korist zdravila Eylea.
Patients in the laser control group could receive additional laser photocoagulation (called ‘rescue laser treatment') beginning at week 12 with a minimum interval of 12 weeks.
Bolniki v kontrolni skupini z laserskim zdravljenjem so bili lahko dodatno zdravljeni z lasersko fotokoagulacijo (imenovano »rešilno lasersko zdravljenje«), ki se je začelo v 12. tednu, z najkrajšim intervalom 12 tednov.
Decreases in mean CNV area were evident in all dose groups in both studies.
Zmanjšanje povprečne velikosti CNV lezije je bilo očitno pri vseh skupinah odmerkov v obeh študijah.
• Concomitant use of other anti-VEGF (vascular endothelial growth factor) There is no data available on the concomitant use of Eylea with other anti-VEGF medicinal products (systemic or ocular).
• Sočasna uporaba drugih zaviralcev VEGF (žilni endotelijski rastni dejavnik) Na voljo ni podatkov glede sočasne uporabe zdravila Eylea z drugimi zaviralci VEGF (sistemski ali okularni).
• Use of povidone iodine or equivalent
• uporaba povidon jodida ali drugega ustreznega sredstva
After 6 consecutive monthly injections, patients received treatment only if they met pre-specified retreatment criteria, except for patients in the control group in the GALILEO study who continued to receive sham (control to control) until week 52.
Po šestih zaporednih mesečnih injekcijah so bolniki prejeli zdravilo le, če so izpolnjevali vnaprej določene kriterije za ponovno zdravljenje, razen bolniki v kontrolni skupini v študiji GALILEO, ki so še naprej prejemali placebo (kontrola kontrolne skupine) do 52. tedna.
The MAH ensures that, following discussions and agreement with the National Competent Authorities in each Member State where Eylea is marketed, ophthalmological clinics where Eylea is expected to be used are provided with an updated physician information pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom zagotavlja, da bo po dogovoru s pristojnim nacionalnim organom v vsaki državi članici, kjer je zdravilo Eylea na trgu, vse očesne klinike, kjer se pričakuje, da bodo zdravilo Eylea uporabljali, prejele posodobljen paket izobraževalnih gradiv za zdravnike, ki bo vseboval naslednje:
In patients treated with Eylea, the majority of whom were classified as having Type II diabetes, a rapid and robust response in morphology (CRT, DRSS level) was observed.
Pri bolnikih, zdravljenih z zdravilom Eylea, od katerih jih je bila večina razvrščenih med bolnike s sladkorno boleznijo tipa II, je bil opažen hiter in robusten morfološki odgovor (CRT, DRSS nivo).
If you experience a sudden decrease in vision, or an increase in pain and redness in your eye after your injection, contact your doctor immediately.
Če se vam vid nenadoma poslabša ali se po injekciji povečata bolečina in pordelost očesa, se takoj posvetujte z zdravnikom.
Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
Filtrirno iglo potisnite v sredino zamaška viale, dokler ni cela igla v viali in se konica dotakne dna ali spodnjega roba viale.
Your doctor will monitor your response to treatment and may continue your treatment by gradually increasing the interval between your injections to maintain a stable condition.
Zdravnik bo spremljal vaš odziv na zdravljenje in za vzdrževanje stabilnega stanja morda nadaljeval zdravljenje s postopnim podaljševanjem intervala med injekcijami.
Eylea is indicated for adults for the treatment of
Zdravilo Eylea je indicirano pri odraslih za zdravljenje
If your condition starts to worsen with a longer treatment interval, your doctor will shorten the interval accordingly.
Če se bo pri podaljšanem intervalu zdravljenja vaše stanje začelo slabšati, bo zdravnik interval ustrezno skrajšal.
In all cases, both the intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
V vseh primerih je treba zato ustrezno spremljati intraokularni tlak in perfuzijo glave vidnega živca in ustrezno ukrepati.