natgillin/translations-raw huggingface dataset:
Reported in clinical studies and in the post-marketing setting.
Poročila iz kliničnih študij in iz obdobja trženja zdravila.
“Numerous” and “intermediate” groups were combined to define the “abundant” group.
Skupini “številno” in “vmesno” so združili v skupino “obilno”.
The majority of patients (72%) were treated with one prior anti-angiogenic therapy.
Večina bolnikov (72 %) se je zdravila z enim predhodnim antiangiogenim zdravljenjem.
investigator's choice (n = 121)
izbira raziskovalca (n = 121)
Thus, the effect of nivolumab on male and female fertility is unknown.
Učinek nivolumaba na plodnost pri moških in ženskah ni znan.
However, the role of this biomarker (tumour PD-L1 expression) has not been fully elucidated.
Vendar pa vloga tega biološkega označevalca (ekspresija PD-L1 tumorja) ni bila povsem pojasnjena.
With a minimum of 63 months follow-up in NSCLC, no new safety signals were identified.
Pri spremljanju uporabe zdravila pri NSCLC, ki je trajalo najmanj 63 mesecev, niso odkrili novih varnostnih signalov.
Efficacy from both studies was evaluated by the same IRRC.
Učinkovitost je v obeh študijah ovrednotil isti neodvisni odbor za radiološki pregled (IRRC).
Infectious and other aetiologies of diarrhoea should be ruled out, therefore appropriate laboratory tests and additional examinations must be performed.
Izključiti je treba okužbe in druge vzroke driske, zato je treba izvesti ustrezne laboratorijske teste in dodatne preiskave.
Use of nivolumab in melanoma patients with rapidly progressing disease
Uporaba nivolumaba pri bolnikih z melanomom s hitro napredujočo obliko bolezni
Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or polyolefin).
Koncentrat prenesite v sterilno, izpraznjeno steklenico ali intravenski vsebnik (PVC ali poliolefin).
Follow-up was ongoing at the time of data submission.
V času predložitve podatkov je spremljanje še trajalo.
Not available as median unstable due to low number of patients and censoring with 24 months of follow-up
Ni podatka zaradi nestabilne mediane, ki je posledica majhnega števila bolnikov in krnjenja podatkov pri 24-mesečnem spremljanju.
withhold the next dose of OPDIVO,
zadrži naslednji odmerek zdravila OPDIVO,
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 Združene države Amerike
No Grade 5 endocrinopathy was reported.
O primerih endokrinopatij stopnje 5 niso poročali.
Patients with cardiac or cardiopulmonary symptoms should be assessed for potential myocarditis.
Bolnike s srčnimi ali srčno-pljučnimi simptomi je treba ovrednotiti glede možnega miokarditisa.
Rare cases of SJS and TEN some of them with fatal outcome have been observed (see sections 4.2 and 4.4).
Poročali so o redkih primerih SJS in TEN, nekateri od njih so se končali s smrtnim izidom (glejte poglavji 4.2 in 4.4).
For patients weighing less than 40 kg, the total volume of infusion must not exceed 4 mL per kilogram of patient weight.
Pri bolnikih s telesno maso, manjšo od 40 kg, skupni volumen infuzije ne sme preseči 4 ml na kilogram telesne mase bolnika.
Updated analysis (24-month follow-up)
Dopolnjena analiza (24-mesečno spremljanje)
Based on modelling of dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between a nivolumab dose of 240 mg every 2 weeks or 3 mg/kg every 2 weeks.
Na osnovi modeliranja razmerij učinkovitosti in varnosti glede na odmerek/izpostavljenost ni klinično pomembnih razlik v učinkovitosti in varnosti uporabe nivolumaba v odmerku 240 mg vsaka 2 tedna ali 3 mg/kg vsaka 2 tedna.
Data unstable due to the limited duration of response for Cohort B resulting from censoring.
b Nestabilnost podatkov je posledica omejenega trajanja odziva za kohorto B, kar je posledica krnjenja.
The MAH shall ensure that in each Member State where OPDIVO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use OPDIVO have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer bo zdravilo OPDIVO na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali OPDIVO, imeli dostop/prejeli naslednji paket izobraževalnih gradiv:
Stable disease, n (%) Duration of response in all responders (months)c
Stabilna bolezen, n (%) Trajanje odziva pri vseh bolnikih z odzivom (meseci)c
NE: non-estimable
NE: neocenljivo.
OPDIVO should not be frozen.
Zdravila OPDIVO ne smete zamrzovati.
Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
predpiše uporabo drugih zdravil, da prepreči zaplete in ublaži simptome,
Data available indicate that the onset of nivolumab effect is delayed such that benefit of nivolumab above chemotherapy may take 2-3 months.
Razpoložljivi podatki kažejo, da je nastop učinka nivolumaba zakasnjen, zato lahko traja 2 do 3 mesece, da korist nivolumaba preseže korist kemoterapije.
Treatment with nivolumab may increase the risk of rejection in solid organ transplant recipients.
Zdravljenje z nivolumabom lahko poveča tveganje za zavrnitev pri prejemnikih presadkov čvrstih organov.
Prior adjuvant or neoadjuvant therapy was allowed if it was completed at least 6 weeks prior to randomisation.
Predhodno adjuvantno ali neoadjuvantno zdravljenje je bilo dovoljeno, če je bilo dokončano vsaj 6 tednov pred randomizacijo.
OS results at an additional analysis undertaken at a minimum follow-up of 36 months show outcomes consistent with the original analysis.
Rezultati celokupnega preživetja pri dodatni analizi, izvedeni po najmanjšem obdobju spremljanja 36 mesecev, so konsistentni z originalno analizo.
After 28 months of follow-up, median OS was not reached in either of the nivolumab containing arms regardless of BRAF status.
Po 28 mesecih spremljanja mediana celokupnega preživetja ni bila dosežena v nobeni od skupin zdravljenja, ki je vključevalo nivolumab, ne glede na status BRAF.
Assessment according to discrete PD-L1 expression intervals were not included in the prespecified analyses due to the small sample sizes within the intervals.
Vrednotenje po diskretnih intervalih ekspresije PD-L1 ni bilo vključeno v vnaprej predvidene analize zaradi premajhne velikosti vzorcev znotraj intervalov.
Prior to launch of OPDIVO in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila OPDIVO na trg se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
The frequency is based on the program-wide exposure.
Pogostnost temelji na podatkih iz programa razširjene uporabe.
The effects of OPDIVO in pregnant women are not known, but it is possible that the active substance, nivolumab, could harm an unborn baby.
Učinki zdravila OPDIVO pri nosečnicah niso znani, vendar pa obstaja možnost, da učinkovina nivolumab škoduje nerojenemu otroku.
This observation was maintained with the OS results with a minimum followup of 36 months.
Opažanja so se ohranila z rezultati za OS po najmanjšem obdobju spremljanja 36 mesecev.
Problems with your lungs such as breathing difficulties or cough.
težave s pljuči, kot so težave z dihanjem ali kašelj.
- Adjuvant treatment of melanoma (monotherapy): study
- Adjuvantno zdravljenje melanoma (monoterapija): študija
Based on a stratified proportional hazards model.
Na osnovi modela stratificiranih proporcionalnih ogroženosti.
Updated analysis Minimum follow-up: 62.7 months a Post-hoc analysis; results should be interpreted with caution as the subgroup samples sizes are small and, at the time of the analysis, the PD-L1 IHC 28-8 pharmDx assay was not analytically validated at the 10% or 50% expression levels.
Dopolnjena analiza Najmanjše obdobje spremljanja: 62,7 meseca a Post-hoc analiza; rezultate je treba interpretirati previdno, saj je velikost vzorca podskupine majhna, v času analize pa test PD-L1 IHC 28-8 pharmDx ni bil analitično validiran pri vrednostih ekspresije 10 % ali 50 %.
PD-L1+ TAIC in the tumour microenvironment were qualitatively assessed, and characterised as “numerous”, “intermediate”, and “rare” based on pathologist assessments.
PD-L1+ TAIC v mikrookolju tumorja so kvalitativno ocenili in na osnovi ocene patologa označili z izrazi “številno”, “vmesno” in “redko”.
Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
Nivolumab je humano monoklonsko protitelo, zato študij farmakokinetičnih interakcij niso izvedli.
For instructions on the preparation and handling of the medicinal product before administration, see section 6.6.
Za navodila glede priprave in ravnanja z zdravilom pred aplikacijo glejte poglavje 6.6.
Based on the stratified DerSimonian-Laird test.
Na osnovi stratificiranega DerSimonian-Lairdovega testa.
Randomisation was stratified by tumour PD-L1 status and M stage (M0/M1a/M1b versus M1c).
Randomizacija je bila stratificirana glede na status PD-L1 tumorja in M stadij (M0/M1a/M1b v primerjavi z M1c).
What OPDIVO is and what it is used for 2.
Kaj je zdravilo OPDIVO in za kaj ga uporabljamo 2.
Guidelines for permanent discontinuation or withholding of doses are described in Table 4.
Smernice za trajno ukinitev zdravljenja ali zadržanje odmerka so navedene v preglednici 4.
The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and > 2 for 21% of patients.
Število predhodnih režimov sistemskega zdravljenja je bilo naslednje: 1 pri 27 % bolnikov, 2 pri 51 % bolnikov in > 2 pri 21 % bolnikov.
For storage conditions after preparation of the infusion, see section 6.3.
Za pogoje shranjevanja po pripravi raztopine za infundiranje glejte poglavje 6.3.
Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Zdravnik se bo z vami pogovoril o možnih neželenih učinkih in vam pojasnil vsa tveganja in koristi zdravljenja.
75 28.88 (18.10, NR)
75 28,88 (18,10; ND)
Withdraw the required volume of OPDIVO concentrate using an appropriate sterile syringe.
Potrebni volumen koncentrata zdravila OPDIVO izvlecite v ustrezno sterilno injekcijsko brizgo.
How to use OPDIVO 4.
Kako uporabljati zdravilo OPDIVO 4.
Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them.
Zaradi možnih neželenih učinkov, kot je utrujenost (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri vožnji ali upravljanju strojev, dokler se z gotovostjo ne izkaže, da nivolumab pri njih nima škodljivih vplivov na tovrstne aktivnosti.
Do not take any other medicines during your treatment without talking to your doctor first.
Med zdravljenjem ne jemljite nobenega drugega zdravila, ne da bi se o tem najprej posvetovali z zdravnikom.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available post-marketing data).
Pogostnost je opredeljena kot: 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), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov po začetku trženja).
EU/1/15/1014/001 40 mg vial EU/1/15/1014/002 100 mg vial EU/1/15/1014/003 240 mg vial
EU/1/15/1014/001 40 mg viala EU/1/15/1014/002 100 mg viala EU/1/15/1014/003 240 mg viala
RFS, assessed by investigator, was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death due to any cause, whichever occurred first.
Preživetje brez ponovitve bolezni je ocenil raziskovalec, opredeljeno pa je bilo kot čas med datumom randomizacije in datumom prve ponovitve (lokalno, regionalno ali oddaljene metastaze), pojava novega primarnega melanoma ali nastopa smrti zaradi katerega koli vzroka, kar koli se je zgodilo prej.
Treatment with nivolumab may increase the risk of severe GVHD and death in patients who have had prior allogeneic HSCT, mainly in those with prior history of GVHD.
Zdravljenje z nivolumabom lahko poveča tveganje za hudo GVHD in smrt pri bolnikih, ki so imeli predhodno alogensko HSCT, predvsem tistih z GVHD v anamnezi.
OPDIVO is for intravenous use only.
Zdravilo OPDIVO je namenjeno le za intravensko uporabo.
One of the Grade 3 pneumonitis cases worsened over 11 days with a fatal outcome.
Pri enem bolniku s pnevmonitisom stopnje 3 se je stanje po 11 dneh poslabšalo in končalo s smrtjo.
Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab or nivolumab in combination with ipilimumab may occur at any time during or after discontinuation of therapy.
Bolnike je treba neprestano nadzirati (še vsaj do 5 mesecev po aplikaciji zadnjega odmerka), saj se neželeni učinki nivolumaba ali nivolumaba v kombinaciji z ipilimumabom lahko pojavijo v katerem koli času med zdravljenjem ali po ukinitvi zdravljenja.
What you need to know before you use OPDIVO 3.
Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO 3.
PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
FARMACEVTSKA OBLIKA IN VSEBINA sterilni koncentrat
Frequencies of laboratory terms reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Pogostnost laboratorijskih terminov odraža delež bolnikov s poslabšanjem glede na izhodiščne laboratorijske izvide.
Recommended dose and infusion time
Priporočeni odmerek in čas infundiranja
Uncommon tubulointerstitial nephritis tubulointerstitial nephritis
Občasni tubulointersticijski nefritis tubulointersticijski nefritis
Computed using Kaplan-Meier method.
Izračunano z uporabo Kaplan-Meierjeve metode.
99.79% CI 95% CI
99,79 % IZ 95 % IZ
N responders/ N evaluablea 95% CIb a includes confirmed and unconfirmed responses, scans were mandatory only at week 8/9 and week 52.
95 % interval zaupanjab a vključuje potrjene in nepotrjene odzive, kontrolni pregledi so bili obvezni le v 8/9.
3.6 (Not available)
3,6 (ni podatka)
The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
Neodprta viala je lahko pri kontrolirani sobni temperaturi do 25 ⁰C in sobni svetlobi shranjena do 48 ur.
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Stevens-Johnsonov sindrom (SJS) ali toksična epidermalna nekroliza (TEN)
For adjuvant therapy, the maximum treatment duration with OPDIVO is 12 months.
Pri adjuvantnem zdravljenju sme zdravljenje z zdravilom OPDIVO trajati največ 12 mesecev.
Stopping your treatment may stop the effect of the medicine.
Če zdravljenje prekinete, lahko učinek zdravila izostane.
No new safety signals were identified in all treated patients and the overall safety profile of nivolumab was similar across subgroups.
Pri nobenem od zdravljenih bolnikov niso odkrili novih varnostnih signalov, celokupni varnostni profil nivolumaba pa je bil podoben pri vseh podskupinah zdravljenih bolnikov.
Determined for subjects with CR or PR NE = non-estimable
Določeno pri bolnikih s CR ali PR NE: neocenljivo.
Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Zvišanje vrednosti aspartat-aminotransferaze (AST), alanin-aminotransferaze (ALT) ali skupnega bilirubina stopnje 2
Additional outcome measures included duration and timing of response.
Dodatna merila izida so vključevala trajanje odziva in čas do nastopa odziva.
Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D.
Izide zdravljenja o katerih so poročali bolniki (PROs, patient-reported outcomes) so ocenili s pomočjo vprašalnikov EORTC QLQ-C30, EORTC QLQ-H&N35 in 3-stopenjskim EQ-5D.
Nivolumab CL in cHL patients was approximately 32% lower relative to NSCLC.
Pri bolnikih s cHL je bil očistek nivolumaba približno 32 % manjši, kot pri bolnikih z NSCLC.
Inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis and Stevens-Johnson syndrome).
vnetje kože, ki lahko napreduje do hude kožne reakcije (znane kot toksična epidermalna nekroliza in Stevens-Johnsonov sindrom).
30th June 2021
30. junij 2021
A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in six patients (12%) within the first 6 weeks post-transplantation, with three patients responding to steroids.
O febrilnem sindromu, ki je zahteval zdravljenje s kortikosteroidi, brez odkritega infektivnega vzroka, so poročali pri šestih bolnikih (12 %) v prvih 6 tednih po presaditvi, s tremi bolniki, ki so odgovorili na zdravljenje s kortikosteroidi.
It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Nivolumab je monoklonsko protitelo, vrsta beljakovine, ki prepozna in se pritrdi na posebno ciljno mesto v telesu.
The median time to onset of objective response was 3.5 months (range: 1.4-24.8 months) after the start of nivolumab treatment.
Mediana časa do nastopa objektivnega odziva je znašala 3,5 meseca (razpon: 1,4-24,8 meseca) po začetku zdravljenja z nivolumabom.
Baseline characteristics were similar across the two studies and cohorts (see Table 20 below).
Izhodiščne lastnosti so v obeh študijah in kohortah podobne (glejte preglednico 20 v nadaljevanju).
Permanently discontinue treatment (see section 4.4)
Zdravljenje trajno ukinite (glejte poglavje 4.4).
The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with OPDIVO use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early recognition/identification of those adverse events.
Izobraževalni program je namenjen povečanju ozaveščenosti o možnosti pojava imunsko pogojenih neželenih učinkov pri uporabi zdravila OPDIVO, kako ukrepati v primeru njihovega pojava in okrepiti ozaveščenost bolnikov oziroma njihovih skrbnikov, o znakih in simptomih, ki so pomembni za zgodnje prepoznavanje/opredelitev teh neželenih učinkov.
Preparation and administration
Priprava in aplikacija
Confidence interval for ORR calculated using the Clopper-Pearson method.
Interval zaupanja za delež objektivnega odziva (ORR) je izračunan s Clopper-Pearsonovo metodo.
c included 4 drug-related deaths: 1 pneumonitis, 1 acute respiratory failure, 1 respiratory failure, and 1 cardiovascular failure.
Vključuje 4 z uporabo zdravila povezane smrtne izide: 1 pnevmonitis, 1 akutno respiratorno odpoved, 1 respiratorno odpoved in 1 kardiovaskularno odpoved.
Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Stevens-Johnsonov sindrom, vitiligo, multiformni eritem, alopecija, psoriaza
What OPDIVO is and what it is used for
Kaj je zdravilo OPDIVO in za kaj ga uporabljamo
The safety and tolerability of nivolumab were investigated in a phase 1, open-label dose-escalation study in various tumour types, including malignant melanoma.
Varnost in prenašanje nivolumaba so raziskovali v odprti študiji 1. faze s povečevanjem odmerka pri različnih vrstah tumorjev, vključno z malignim melanomom.
Calculating the dose
Izračun odmerka
Not reached (2.9-20.5+)
ni dosežena (2,9-20,5+)
Patients had to have a Karnofsky Performance Score (KPS) ≥ 70%.
Bolniki so imeli oceno stanja telesne zmogljivosti po Karnofskem (KPS)  70 %.
Combination phase, every 3 weeks for 4 dosing cycles
Faza kombiniranega zdravljenja, vsake 3 tedne, 4 odmerki
All prescribers of OPDIVO must be familiar with the Physician Information and Management Guidelines.
Vsak zdravnik, ki predpisuje zdravilo OPDIVO, se mora seznaniti z izobraževalnim gradivom za zdravnike in smernicami za ukrepanje.
The median duration of response was not reached (range: 4.4-16.6+ months).
Mediana trajanja odziva ni bila dosežena (razpon: 4,4-16,6+ meseca).
Hyperacute GVHD, defined as acute GVHD occurring within 14 days after stem cell infusion, was reported in three patients (6%).
O hiperakutni GVHD, ki je bila opredeljena kot akutna GVHD, ki se je pojavila v 14 dneh po infundiranju matičnih celic, so poročali pri treh bolnikih (6 %).
Most patients present with asymptomatic increases in serum creatinine.
Večina bolnikov je imela le asimptomatsko zvišano vrednost serumskega kreatinina.
Sixteen percent of patients had received prior adjuvant therapy; the most common adjuvant treatment was interferon (9%).
16 % bolnikov se je predhodno zdravilo adjuvantno, najpogosteje uporabljeno adjuvantno zdravilo pa je bil interferon (9 %).
What you need to know before you use OPDIVO
Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO
With a minimum of 62.6 months follow-up, OS benefit remains consistently demonstrated across subgroups.
Pri spremljanju, ki je trajalo najmanj 62,6 meseca, je korist za celokupno preživetje ostala konsistentna po vseh podskupinah bolnikov.
Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines.
Na osnovi farmakodinamičnih lastnosti nivolumaba je njegov vpliv na sposobnost vožnje in upravljanja strojev malo verjeten.
Due to the small numbers of patients in the subgroups, and exploratory nature of the analysis, no definitive conclusions can be drawn from these data.
Zaradi majhnega števila bolnikov v podskupini in eksplorativne narave analize ti podatki ne omogočajo definitivnih zaključkov.
Uncommon bronchitis bronchitis, aseptic meningitis
Občasni bronhitis bronhitis, aseptični meningitis
OPDIVO alone or in combination with ipilimumab may cause changes in the results of tests carried out by your doctor.
Zdravilo OPDIVO lahko samo ali v kombinaciji z ipilimumabom povzroči spremembe v izvidih preiskav, ki jih bo opravil zdravnik.
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
O posebnih razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
Table 9: Best overall response, time and duration of response (CA209037)
Preglednica 9: Najboljši celokupni odziv, čas in trajanje odziva (študija CA209037)
All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Po mnenju raziskovalcev nobeden ni bil povezan z uporabo nivolumaba, razen aritmije (atrijska fibrilacija, tahikardija in ventrikularna aritmija).
Rare cases of SJS and TEN some of them with fatal outcome have been observed.
Poročali so o redkih primerih SJS in TEN, nekateri od njih so se končali s smrtnim izidom.
Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
Podatki o daljšem obdobju spremljanja iz kohorte B (najmanj 20,5 meseca) in učinkovitosti iz kohorte C iz študije CA209205 so prikazani v preglednici 22.
Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Poročali so o atipičnih odzivih (npr. prehodno povečanje velikosti tumorja ali pojav manjših novih sprememb na začetku zdravljenja v prvih nekaj mesecih, nato pa je sledilo zmanjšanje tumorja).
Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia.
Anemija je sestavljen izraz, ki med drugimi vzroki vključuje hemolitično anemijo in avtoimunsko anemijo.