natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
Rare: may affect up to 1 in 1,000 people:
Redki: lahko se pojavijo pri največ 1 od 1.000 oseb: preobčutljivostne reakcije izpuščaj, koprivnica
Healthcare professionals are asked to report any suspected adverse reactions via [the national reporting system listed in Appendix V*].
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*].
These amendments to the relevant sections of the Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Ta dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so nastala med napotitvenim postopkom.
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]
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]
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]
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]
There have been reports of severe skin reactions associated with the administration of <active substance>.
Poročali so, da so z dajanjem <zdravilna učinkovina> povezane hude kožne reakcije.
[The following warning should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
[Za vsa zdravila, ki vsebujejo ambroksol in bromheksin, se mora v tem poglavju odraziti naslednje opozorilo]
Rare: rash, urticaria
Redki: izpuščaj, urtikarija
[The below paragraph should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
[Za vsa zdravila, ki vsebujejo ambroksol in bromheksin, se mora v tem poglavju odraziti spodnji odstavek]
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).
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).
Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus Skin and subcutaneous tissue disorders
Neznana pogostnost: anafilaktične reakcije, vključno z anafilaktičnim šokom, angioedemom in pruritusom
Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Neznana pogostnost: hude kožne neželene reakcije (vključno z multiformnim eritemom, StevensJohnsonovim sindromom/toksično epidermalno nekrolizo in akutno generalizirano eksantematozno pustulozo).
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo
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>.
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).
[The following sub-heading should appear at the end of this section] Reporting of side effects
[Na koncu tega poglavja je treba vključiti naslednje podpoglavje]
Rash, urticaria
Bolezni kože in podkožja
• Your doctor will decide how many treatments you need.
• Zdravnik bo določil, koliko zdravljenj potrebujete.
Date of first authorisation: 21 September 2018
Datum prve odobritve: 21. september 2018
b (months)
b (meseci)
NR: Not Reached
ND: ni doseženo
However, a potential risk to the breast-fed child cannot be excluded.
Toda možnega tveganja za dojenega otroka ni mogoče izključiti.
• It is very important that you do not miss a dose of this medicine.
• Zelo pomembno je, da ne izpustite odmerka tega zdravila.
The analysis of OS was performed approximately 13 months after the primary analysis of PFS.
Analizo OS so izvedli približno 13 mesecev po primarni analizi PFS.
Steady state was achieved at approximately 16 weeks.
Stanje dinamičnega ravnovesja je bilo doseženo po približno 16 tednih.
The presence of ADAs did not have a clinically relevant effect on safety.
Prisotnost ADAs ni klinično pomembno vplivala na varnost.
See Table 3 and Figures 1 and 2.
Glejte preglednico 3 in sliki 1 in 2.
This 1 patient received insulin.
Ta bolnik je prejemal insulin.
Dose escalation or reduction is not recommended.
Povečevanje ali zmanjševanje odmerka ni priporočljivo.
Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms.
Zdravnik lahko uporabi še druga zdravila, ki preprečujejo še hujše zaplete in za zmanjšanje vaših simptomov.
• you have an autoimmune disease (an illness where the body's immune system attacks its own cells);
• če imate kakšno avtoimunsko bolezen (bolezen, pri kateri telesni imunski sistem napada celice lastnega telesa);
Probability of PFS
Verjetnost PFS
Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje na področju zdravljenja raka.
The time to onset was 42 days.
Čas do pojava je bil 42 dni.
All Patients
Vsi bolniki
• has responded or stabilised after initial treatment with chemotherapy and radiotherapy.
• se je odzval ali stabiliziral po začetnem zdravljenju s kemoterapijo in obsevanjem.
Adrenal insufficiency
Adrenalna insuficienca
• Do not co-administer other medicinal products through the same infusion line.
• Tega zdravila ne dajajte skupaj z drugimi zdravili po isti infuzijski liniji.
If refrigerated, intravenous bags must be allowed to come to room temperature prior to use.
Če so intravenske vrečke shranjene v hladilniku, jih je treba pustiti, da pred uporabo dosežejo sobno temperaturo.
• The medicinal product, once diluted, should be used immediately.
• Ko je zdravilo razredčeno, ga je treba uporabiti takoj.
Patients with disease control at 12 months were given the option to be re-treated upon disease progression.
Bolniki, pri katerih je bila bolezen po 12 mesecih obvladana, so imeli možnost ponovnega zdravljenja po napredovanju bolezni.
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.
PFS2 je opredeljeno kot čas od datuma randomizacije do datuma drugega napredovanja bolezni (opredeljenega v okviru običajne lokalne klinične prakse) ali smrti.
ATC code: L01XC28
Oznaka ATC: L01XC28
In humans, antibodies may be transferred to breast milk, but the potential for absorption and harm to the newborn is unknown.
Pri človeku protitelesa lahko prehajajo v materino mleko, a možnost absorpcije in škode za novorojenčka ni znana.
PFS was assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.
PFS je bila ocenjena s slepljenim neodvisnim centralnim pregledom (BICR - “Blinded Independent Central Review”) v skladu z merili RECIST v1.1.
EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
EU/1/18/1322/002 120-mg viala EU/1/18/1322/001 500-mg viala
Common Terminology Criteria for Adverse Events, version 4.03.
Enotna razvrstitvi meril neželenih učinkov (“Common Terminology Criteria for Adverse Event”), različica 4.03.
The demographics and baseline disease characteristics were well balanced between study arms.
Demografske značilnosti in izhodiščne značilnosti bolezni so bile med študijskima skupinama dobro uravnotežene.
If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Če imate vprašanja o tem, kako deluje zdravilo IMFINZI ali zakaj ste ga dobili, vprašajte zdravnika ali farmacevta.
Fertility There are no data on the potential effects of durvalumab on fertility in humans or animals.
Plodnost Podatkov o možnih vplivih durvalumaba na plodnost pri človeku ali živalih ni.
<Other sources of information>
Drugi viri informacij
Any Grade (%)
Katera koli stopnja (%)
Carcinogenicity and mutagenicity The carcinogenic and genotoxic potential of durvalumab has not been evaluated.
Karcinogenost in mutagenost Karcinogenega in genotoksičnega potenciala durvalumaba niso ocenili.
Children and adolescents IMFINZI should not be used in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravila IMFINZI se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
Dati ga je treba kot raztopino za intravensko infundiranje v obdobju 60 minut (glejte poglavje 6.6).
• has spread within your lung and cannot be removed by surgery, and
• razširil v pljučih in ga ni mogoče odstraniti z operacijo in
Grade 3-4 (%)
3.-4. stopnja (%)
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.
Varnost in učinkovitost zdravila IMFINZI pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Končna koncentracija razredčene raztopine mora biti med 1 mg/ml in 15 mg/ml.
• painful urination
• boleče uriniranje
This includes herbal medicines and medicines obtained without a prescription.
To velja tudi za zeliščna zdravila in druga zdravila, ki ste jih dobili brez recepta.
Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker).
Randomizacija je bila stratificirana po spolu, starosti (< 65 let in ≥ 65 let) in kadilsko stanje (kadilci in nekadilci).
• Call your doctor straight away to reschedule your appointment.
• Takoj pokličite zdravnika, da se boste dogovorili za nov datum obiska.
There are insufficient number of patients to determine ADA impact on efficacy.
Število bolnikov je premajhno, da bi ugotovili, kakšen vpliv imajo ADA na učinkovitost.
If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy.
Če v 3 do 5 dneh kljub uporabi kortikosteroidov ne pride do izboljšanja, takoj začnite z dodatnim imunosupresivnim zdravljenjem.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI.
Večina teh, učinkov vključno s hudimi, je izzvenela po uvedbi ustreznega zdravljenja ali prenehanju uporabe zdravila IMFINZI.
IMFINZI (n = 476)
Zdravilo IMFINZI (n = 476)
No overall differences in safety were reported between elderly (≥ 65 years) and younger patients.
Glede varnosti niso poročali o razlikah med starejšimi (starimi 65 let ali več) in mlajšimi bolniki v celoti.
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).
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).
• It is not known if IMFINZI passes into human breast milk.
• Ni znano, ali zdravilo IMFINZI prehaja v materino mleko.
Probability of OS
Verjetnost OS
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.
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.
What IMFINZI is and what it is used for
Kaj je zdravilo IMFINZI in za kaj ga uporabljamo
The terminal half-life (t1/2), based on baseline CL, was approximately 18 days.
Terminalni razpolovni čas (t1/2) na podlagi izhodiščnega očistka je bil približno 18 dni.
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti lastniško ime in številko serije uporabljenega zdravila.
• you have had an organ transplant;
• če imate kakšen presajen organ;
However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
Toda če imate neželene učinke, ki vam poslabšajo sposobnost za zbranost in reagiranje, morate biti pri upravljanju vozil in strojev previdni.
Do not store any unused portion of the infusion solution for re-use.
Morebitnega neporabljenega dela raztopine za infundiranje ne shranjujte za ponovno uporabo.
IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Zdravilo IMFINZI boste dobili v bolnišnici ali ambulanti pod nadzorstvom izkušenega zdravnika.
Tumour assessments were conducted every 8 weeks for the first 12 months and then every 12 weeks thereafter.
Ocenjevanje tumorja so izvajali na 8 tednov prvih 12 mesecev, nato pa na 12 tednov.
The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg.
Raztopina ima pH približno 6,0 in osmolalnost približno 400 mOsm/kg.
Store in the original package in order to protect from light.
Shranjujte v originalni ovojni za zagotovitev zaščite pred svetlobo.
The improvements in PFS and OS in favour of patients receiving IMFINZI compared to those receiving placebo were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history, EGFR mutation status and histology.
Izboljšanje PFS in OS v korist prejemnikov zdravila IMFINZI v primerjavi s prejemniki placeba so dosledno opažali v vseh vnaprej določenih analiziranih podskupinah, vključno z etnično pripadnostjo, starostjo, spolom, anamnezo kajenja, stanjem mutacij EGFR in histologijo.
Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with durvalumab, and includes the serious side effects listed in section 2:
Nemudoma se posvetujte z zdravnikom, če se vam pojavi kateri od naslednjih neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih z durvalumabom in vključujejo resne neželene učinke, navedene v poglavju 2:
For single use only.
samo za enkratno uporab
Disease characteristics were as follows: Stage IIIA (53%), Stage IIIB (45%), histological sub-groups of squamous (46%), non-squamous (54%).
Značilnosti bolezni so bile: stadij IIIA (53 %), stadij IIIB (45 %), histološki podskupini ploščatocelični (46 %), neploščatocelični (54 %).
Night sweats
• nočno znojenje
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
ALT: alanin-aminotransferaza; AST: aspartat-aminotransferaza; ZNM: zgornja meja normalne vrednosti.
Patient-reported symptoms, function and health-related quality of life (HRQoL) were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Simptome, funkcijo in zdravstveno kakovost življenja po navedbi bolnikov so evidentirali z uporabo EORTC QLQ-C30 in njegovega modula za pljučnega raka (EORTC QLQ-LC13).
One patient also received infliximab treatment.
En bolnik je prejemal tudi zdravljenje z infliksimabom.
PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment.
PD-L1 lahko inducirajo vnetni signali (npr. IFN-gama) in je lahko izražen tako na tumorskih celicah kot na imunskih celicah v mikrookolju tumorja.
Grade 3 or 4, or any Grade with positive biopsy
3. ali 4. stopnja ali katera koli stopnja s pozitivno biopsijo trajno prenehajte uporabljati
Recommended treatment modifications for IMFINZI and management recommendations
Priporočene prilagoditve zdravljenja z zdravilom IMFINZI in priporočila za obvladovanje
A decision must be made whether to discontinue breast feeding or to discontinue or abstain from durvalumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba, ali naj ženska prekine z dojenjem ali naj prekine zdravljenje z durvalumabom oziroma sploh ne začne zdravljenja z njim, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za žensko.
Eight patients experienced hypothyroidism following hyperthyroidism.
Osmim bolnikom se je po hipertiroidizmu pojavil hipotiroidizem.
Secondary efficacy endpoints included PFS at 12 months (PFS 12) and 18 months (PFS 18) from randomisation and Time from Randomisation to Second Progression (PFS2).
Sekundarni cilji študije učinkovitosti so obsegali PFS po 12 mesecih (PFS 12) in 18 mesecih (PFS 18) od randomizacije, in čas od randomizacije do drugega napredovanja bolezni (PFS2).
• reaction to the infusion of the medicine that can cause fever or flushing
• reakcija na infundiranje zdravila, ki lahko povzroči vročino ali zardevanje
No formal pharmacokinetic (PK) drug-drug interaction studies have been conducted with durvalumab.
Z durvalumabom niso izvedli formalnih farmakokinetičnih (PK) študij medsebojnega delovanja zdravil.
IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage.
Zdravilo IMFINZI vam bodo odmerjali v bolnišnici ali ambulanti in za shranjevanje zdravila bodo odgovorni zdravstveni delavci.
• Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
• a condition leading to high blood sugar levels (type 1 diabetes mellitus)
• bolezen, ki povzroča visoke koncentracije sladkorja v krvi (sladkorna bolezen tipa 1)
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino (učinkovine) ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Ask your doctor if you can breast-feed during or after treatment with IMFINZI.
• Vprašajte zdravnika, ali smete dojiti med zdravljenjem z zdravilom IMFINZI in po njem.
What you need to know before you are given IMFINZI
Kaj morate vedeti, preden boste dobili zdravilo IMFINZI
Data on patients aged 75 years of age or older are limited.
Podatkov o bolnikih, ki so stari 75 let ali več, je malo.
g frequency is based on events not observed in the PACIFIC Study but observed in other clinical trials (n=1889).
Pogostnost se nanaša na dogodke, ki jih niso opažali v študiji PACIFIC, opažali pa so jih v drugih kliničnih študijah (n = 1889).
Pack size of 1 vial.
Pakiranje vsebuje 1 vialo.
Durvalumab has no or negligible influence on the ability to drive and use machines.
Durvalumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
• če ste alergični na durvalumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6
Based on population PK analysis, slightly lower exposure are expected in ADA-positive patients however, the reduction of PK exposure is less than 30% compared to a typical patient and is not considered clinically relevant.
Na podlagi populacijske farmakokinetične analize je mogoče pri bolnikih s prisotnimi ADA pričakovati nekoliko manjšo izpostavljenost zdravilu, vendar je farmakokinetična izpostavljenost za manj kot 30 % manjša od izpostavljenosti pri tipičnem bolniku in ne velja za klinično pomembno.
IMFINZI is for intravenous use.
Zdravilo IMFINZI je namenjeno za intravensko uporabo.
Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Glede na mehanizem delovanja zdravila IMFINZI se lahko pojavijo še drugi potencialno imunsko pogojeni učinki.
The LC13 and C30 were assessed at baseline, every 4 weeks for the first 8 weeks, followed by every 8 weeks until completion of the treatment period or discontinuation of IMFINZI due to toxicity or disease progression.
LC13 in C30 so ocenili izhodiščno, potem na 4 tedne prvih 8 tednov in nato na 8 tednov do konca obdobja zdravljenja ali do prenehanja zdravljenja z zdravilom IMFINZI zaradi toksičnosti ali napredovanja bolezni.
Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Durvalumab je pridobljen v celicah sesalcev (jajčnik kitajskega hrčka) s tehnologijo rekombinantne DNK.
Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth (see section 5.3).
Razpoložljivi toksikološki podatki pri opicah cynomolgus so pokazali nizko koncentracijo durvalumaba v materinem mleku 28. dan po rojstvu (glejte poglavje 5.3).
Events of pancreatitis have been reported in patients in the clinical study programme.
V programu kliničnih študij so pri bolnikih poročali o primerih pankreatitisa.
Human IgG1 is known to cross the placental barrier and placental transfer of durvalumab was confirmed in animal studies.
Znano je, da človeški IgG1 prehajajo skozi placentno pregrado in prehajanje durvalumaba skozi placento so potrdili s študijami na živalih.
No dose adjustment is required for elderly patients (≥ 65 years of age) (see section 5.1).
Starejšim bolnikom (starost ≥ 65 let) odmerka ni treba prilagoditi (glejte poglavje 5.1).
k includes colitis, enteritis, enterocolitis, and proctitis.
Vključuje kolitis, enteritis, enterokolitis in proktitis.
What IMFINZI is and what it is used for What you need to know before you are given IMFINZI How you are given IMFINZI Possible side effects
Kaj je zdravilo IMFINZI in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo IMFINZI Kako boste dobili zdravilo IMFINZI Možni neželeni učinki
It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Pri klinično stabilnih bolnikih z začetnimi znaki napredovanja bolezni je priporočeno z zdravljenjem nadaljevati, dokler napredovanje bolezni ni potrjeno.