natgillin/translations-raw huggingface dataset:
KEYTRUDA works by helping your immune system fight your cancer. 
Zdravilo KEYTRUDA deluje tako, da imunskemu sistemu pomaga premagovati rak.
Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. 
V primeru suma na pnevmonitis je treba pnevmonitis potrditi z radiografskim slikanjem in izključiti druge vzroke.
Methotrexate, docetaxel, or cetuximab 
Metotreksat, docetaksel ali cetuksimab
If you have any of the following conditions, call or see your doctor right away. 
Če opazite katerega od naslednjih pojavov, takoj pokličite ali obiščite zdravnika.
Patients treated with KEYTRUDA must be given the Patient Alert Card and be informed about the risks of KEYTRUDA (see also package leaflet). 
Bolniki, ki so zdravljeni z zdravilom KEYTRUDA, morajo prejeti opozorilno kartico za bolnike in morajo biti obveščeni o tveganjih, povezanih z zdravljenjem z zdravilom KEYTRUDA (glejte tudi Navodilo za uporabo).
In patients with solid tumours and other lymphomas, the ORR was 5.9%, no patient had a complete response and 8 patients (5.9%) had a partial response. 
Pri bolnikih s čvrstimi tumorji in drugimi limfomi je bil ORR 5,9 %, pri nobenem bolniku ni prišlo do popolnega odgovora, pri 8 bolnikih (5,9 %) pa je prišlo do delnega odgovora.
Common (may affect up to 1 in 10 people) - lung infection - decrease in the number of red blood cells; decreased number of white blood cells (neutrophils, 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - okužba pljuč - zmanjšano število rdečih krvnih celic, zmanjšano število belih krvnih celic (nevtrofilcev,
Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered. 
Po okrevanju je mogoče razmisliti o ponovni uvedbi enega samega zdravila ali zaporedoma obeh.
• sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks. 
• sunitinib v odmerku 50 mg peroralno enkrat na dan 4 tedne in nato 2 tedna brez zdravljenja.
Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). 
Redko so opazili primere SJS in TEN, v nekaterih primerih so se ti končali s smrtnim izidom (glejte poglavji 4.2 in 4.4).
*Adverse reaction frequencies presented in Table 2 may not be fully attributable to pembrolizumab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. 
*Pogostnosti neželenih učinkov, navedene v preglednici 2, morda niso v celoti posledica le zdravljenja s pembrolizumabom, temveč lahko odražajo tudi osnovno bolezen ali uporabo drugih zdravil v kombinaciji.
Corticosteroid therapy may be considered. 
Lahko se razmisli o zdravljenju s kortikosteroidi.
Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. 
Imunsko pogojeni neželeni učinki so se pojavili tudi po zadnjem odmerku pembrolizumaba.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see “Description of selected adverse reactions” below). 
Večina, vključno s hudimi učinki, je po uvedbi ustreznega zdravljenja ali ukinitvi zdravljenja s pembrolizumabom izzvenela (glejte "Opis izbranih neželenih učinkov" spodaj).
* Includes patients without measurable disease at baseline by independent radiology IRO = Integrated radiology and oncologist assessment using RECIST 1.1 
* Vključuje bolnike, ki izhodiščno po neodvisni radiološki presoji niso imeli merljive bolezni IRO = integrirana radiološka in onkološka presoja z uporabo RECIST 1.1
Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. 
Na podlagi maloštevilnih podatkov iz kliničnih študij se lahko pri bolnikih, pri katerih se imunsko pogojenih neželenih učinkov ne da obvladati z uporabo kortikosteroidov, razmisli o uporabi drugih sistemskih imunosupresivov.
• Genomic analyses using whole exome sequencing and/or RNAseq (e.g. 
• Genomske analize s sekvencioniranjem celotnega eksoma in/ali sekvencioniranjem RNA (npr. Nanostring RNA genetski podpis)
* Cetuximab, platinum, and 5-FU † Based on the stratified Cox proportional hazard model ‡ Response: Best objective response as confirmed complete response or partial response 
* Cetuksimab, platina in 5-fluorouracil Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor
The patient will be provided with the Patient Alert Card with each prescription. 
Bolnik bo prejel opozorilno kartico vsakokrat, ko mu bo zdravilo predpisano.
Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered. 
Pri teh bolnikih se pri 55 % zvišanje vrednosti ALT na > 3-krat nad ZNM ni ponovilo, bolniki, pri katerih se je vrednost ALT ponovno zvišala za > 3-krat nad ZNM, pa so vsi okrevali.
KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) 
KEYNOTE-087 in KEYNOTE-013: odprti študiji pri bolnikih s ponovljenim ali neodzivnim klasičnim Hodgkinovim limfomom (cHL)
Disease subtypes were 80% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted. 
Podtipi bolezni so bili: 80 % nodularna skleroza, 11 % mešanocelični, 4 % z limfociti bogati in 2 % tip limfocitne deplecije.
The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment. 
Mediana celokupnega preživetja (OS) je pri pembrolizumabu znašala 8,4 meseca v primerjavi s 7,1 meseca pri standardnem zdravljenju.
Exposure to pembrolizumab as expressed by peak concentration (Cmax) or area under the plasma concentration time curve (AUC) increased dose proportionally within the dose range for efficacy. 
Izpostavljenost pembrolizumabu, izražena z največjo koncentracijo (Cmax) ali površino pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC), se je v razponu odmerkov za učinkovitost povečevala sorazmerno odmerku.
Do not stop treatment with KEYTRUDA unless you have discussed this with your doctor. 
Zdravljenja z zdravilom KEYTRUDA ne prenehajte, ne da bi se o tem posvetovali z zdravnikom.
% ongoing 
% še trajajočih
The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known. 
Varnost ponovne uvedbe zdravljenja s pembrolizumabom pri bolnikih, pri katerih se je pojavil imunsko pogojeni miokarditis, ni znana.
Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. 
Večina imunsko pogojenih neželenih učinkov, ki so se pojavili med zdravljenjem s pembrolizumabom, je bila reverzibilnih in so jih obvladali s prekinitvami uporabe pembrolizumaba, uporabo kortikosteroidov in/ali podporno oskrbo.
#) of patients with duration ≥ 6 months Number (% 
#) bolnikov s trajanjem ≥ 6 mesecev število (%
Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. 
Bolnike je treba spremljati glede sprememb delovanja jeter (na začetku zdravljenja, periodično med zdravljenjem in kot je indicirano glede na klinično oceno) in simptomov hepatitisa ter izključiti druge vzroke.
Sixty-seven percent (67%) of patients had M1 disease and the majority had Stage IV disease (Stage IV 32%, Stage IVa 14%, Stage IVb 4%, and Stage IVc 44%). 
Sedeminšestdeset odstotkov (67 %) bolnikov je imelo M1 bolezen, večina bolnikov pa je imela bolezen v stadiju IV (stadij IV 32 %, stadij IVa 14 %, stadij IVb 4 % in stadij IVc 44 %).
Each vial contains an excess fill of 0.25 ml (total content per vial 4.25 ml) to ensure the recovery of 4 ml of concentrate. 
Vsaka viala vsebuje prekomerno polnitev 0,25 ml (celotna vsebina na vialo 4,25 ml) za zagotovitev dobljene količine 4 ml koncentrata.
For patients ≥ 75 years, pembrolizumab combination therapy should be used with caution after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). 
Pri bolnikih, starih ≥ 75 let, je treba kombinirano zdravljenje s pembrolizumabom uporabljati previdno, po skrbni oceni možnih koristi in tveganj za posameznega bolnika (glejte poglavje 5.1).
Uncommon type 1 diabetes mellitus type 1 diabetes mellitus type 1 diabetes mellitus 
sladkorna bolezen tipa 1 sladkorna bolezen tipa 1
Uncommon epilepsy epilepsy myasthenic syndrome 
Občasni epilepsija epilepsija miastenični sindrom
% ongoing at 12 months 
% še trajajočih po 12 mesecih
- KEYTRUDA can cause harm or death to your unborn baby. 
- Zdravilo KEYTRUDA lahko škoduje nerojenemu otroku ali povzroči njegovo smrt.
Overall Survival (%) 
celokupno preživetje (OS) (%)
In urothelial cancer, a higher number of deaths within 2 months was observed in pembrolizumab compared to chemotherapy (see section 5.1). 
Pri urotelijskem raku so pri pembrolizumabu v 2 mesecih opažali večje število smrti kot pri kemoterapiji (glejte poglavje 5.1).
(see Table 22). 
Kit (glejte preglednico 22).
Immune-related adverse reactions (see section 4.4) 
Imunsko pogojeni neželeni učinki (glejte poglavje 4.4)
3 weeks (maximum of 6 cycles of platinum and 5-FU) 
(največ 6 ciklusov platine in 5-fluorouracila)
Two patients (< 0.1%) discontinued pembrolizumab due to hypothyroidism. 
Dvema bolnikoma (< 0,1 %) so ukinili zdravljenje s pembrolizumabom zaradi hipotiroidizma.
The frequencies are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. 
Pogostnosti temeljijo na vseh poročanih neželenih učinkih zdravila, ne glede na raziskovalčevo oceno o vzročnosti.
For signs or symptoms of SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. 
V primeru znakov in simptomov SJS in TEN je treba uporabo pembrolizumaba zadržati, bolnika pa napotiti k ustreznemu specialistu na preiskave in zdravljenje.
Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity. 
Podtipa bolezni sta bila: 97 % nodularna skleroza in 3 % mešanocelični.
, influenza like illness, chills 
, gripi podobna bolezen, mrzlica
Your doctor may withhold the next dose of KEYTRUDA or stop your treatment with KEYTRUDA. 
Zdravnik lahko odloži naslednji odmerek ali prekine zdravljenje z zdravilom KEYTRUDA.
PD-L1 negative n=428 
PD-L1 negativni n = 428
The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. 
V stanju dinamičnega ravnovesja geometrijska srednja vrednost (KV %) končnega razpolovnega časa znaša 22 dni (32 %).
Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. 
Klinično stabilni bolniki z začetnimi znaki napredovanja bolezni so lahko nadaljevali zdravljenje, dokler napredovanje bolezni ni bilo potrjeno.
People get KEYTRUDA when their cancer has spread or cannot be taken out by surgery. 
Bolniki prejmejo zdravilo KEYTRUDA, ko se je rak razširil ali ga ni mogoče odstraniti z operacijo.
More frequent monitoring of liver enzymes as compared to when the medicines are used in monotherapy may be considered. 
Lahko se razmisli o pogostejšem spremljanju jetrnih encimov, kot v primeru uporabe zdravil v okviru samostojnega zdravljenja.
• a kind of skin cancer called melanoma 
• vrste kožnega raka, imenovanega melanom,
Median (95% CI), months 
mediana (95 % IZ), meseci
In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data. 
V analizi podskupine so pri majhnem številu bolnikov, ki niso nikoli kadili, opazili zmanjšano korist pembrolizumaba za preživetje v primerjavi s kemoterapijo, vendar zaradi majhnega števila bolnikov končni zaključki na podlagi teh podatkov niso mogoči.
• IHC staining for PD-L2 
• Barvanje po metodi IHC za PD-L2
When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. 
Če se zdravilo KEYTRUDA uporablja kot del kombiniranega zdravljenja skupaj z intravensko kemoterapijo, je treba zdravilo KEYTRUDA aplicirati prvo.
Warnings and precautions Talk to your doctor or nurse before receiving KEYTRUDA. 
Opozorila in previdnostni ukrepi Preden prejmete zdravilo KEYTRUDA, se posvetujte z zdravnikom ali medicinsko sestro.
When used in combination with pembrolizumab, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer (see section 5.1). 
Če je aksitinib uporabljen v kombinaciji s pembrolizumabom, se lahko razmisli o povečanju odmerka aksitiniba nad začetnih 5 mg v presledkih šest tednov ali več (glejte poglavje 5.1).
Assessment of PD-L1 status 
Ocena statusa PD-L1
Table 17 summarises key efficacy measures for the entire population (TPS  1%) and for the patients with TPS  50%, and Figure 11 shows the Kaplan-Meier curve for OS (TPS  1%), based on a final analysis with median follow up of 42.6 months. 
Preglednica 17 povzema ključna merila učinkovitosti za celotno populacijo (TPS  1 %) in za bolnike s TPS  50 %, slika 11 pa prikazuje Kaplan-Meierjevo krivuljo celokupnega preživetja (TPS  1 %) na podlagi končne analize z medianim časom spremljanja 42,6 meseca.
Not reached (1.4+, 18.2+) 
ni dosežena (1,4+; 18,2+)
Feeling tired or weak is a very common side effect of KEYTRUDA. 
Utrujenost in šibkost sta zelo pogosta neželena učinka zdravila KEYTRUDA.
Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia). 
Randomizacija je bila stratificirana glede na izraženost PD-L1 tumorja (TPS < 1 % [negativni] ali TPS ≥ 1 %), raziskovalčevo izbiro paklitaksela ali nab-paklitaksela in geografsko regijo (vzhodna Azija ali ne-vzhodna Azija).
The most common tumour types by histology were Hodgkin lymphoma (11.7%), glioblastoma multiforme (9.1%), neuroblastoma (6.5%), osteosarcoma (6.5%) and melanoma (5.2%). 
Najpogostejše vrste tumorjev glede na histologijo so bile: Hodgkinov limfom (11,7 %), multiformni glioblastom (9,1 %), nevroblastom (6,5 %), osteosarkom (6,5 %) in melanom (5,2 %).
For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. 
Pri adjuvantnem zdravljenju melanoma je treba zdravilo KEYTRUDA uporabljati do ponovitve bolezni, pojava nesprejemljivih toksičnih učinkov oziroma mora zdravljenje trajati do enega leta.
A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja s pembrolizumabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja s pembrolizumabom za mater.
However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). 
Vendar pa je kortikosteroide ali druge imunosupresive mogoče uporabiti po uvedbi zdravljenja s pembrolizumabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.4).
BRAF mutations were reported in 20 (39%) patients. 
Mutacije BRAF so bile ugotovljene pri 20 (39 %) bolnikih.
While the analysis in patients with PD-L1 positive tumours was a co-primary endpoint, pre-defined subgroup analyses were performed in patients whose tumours were PD-L1 negative, BRAF mutation positive or negative. 
Medtem ko je bila analiza pri bolnikih s PD-L1 pozitivnimi tumorji sočasni primarni opazovani dogodek, so bile izvedene tudi vnaprej predvidene analize po podskupinah pri bolnikih s PD-L1 negativnimi tumorji ter pozitivno ali negativno mutacijo BRAF.
Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. 
Bolniki, pri katerih se je po postopku presaditve razvila GVHD, imajo lahko povečano tveganje za pojav GVHD po zdravljenju s pembrolizumabom.
Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually. 
Pri bolnikih so slikovne preiskave opravljali vsakih 12 tednov po prvem odmerku pembrolizumaba prvi dve leti, nato pa vsakih 6 mesecev od 3. do 5. leta in nato enkrat na leto.
A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy. 
Skupno 67 bolnikov v skupini s placebom in kemoterapijo je v času napredovanja bolezni prešlo na samostojno zdravljenje s pembrolizumabom, še dodatnih 18 bolnikov pa je pri nadaljnjem zdravljenju prejelo zaviralca kontrolnih točk.
Table 22: ORR and OS by PD-L1 Expression 
Preglednica 22: ORR in OS glede na izraženost PD-L1
Each vial contains an excess fill of 10 mg (0.4 mL) to ensure the recovery of 50 mg of KEYTRUDA per vial. 
Vsaka viala vsebuje prekomerno polnitev 10 mg (0,4 ml) za zagotovitev dobljene količine 50 mg zdravila KEYTRUDA na vialo.
These medicines may interfere with the effect of KEYTRUDA. 
Ta zdravila lahko medsebojno delujejo z zdravilom KEYTRUDA.
Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4). 
Opomba: Stopnje toksičnosti so navedene v skladu z verzijo 4.0 Terminološko poenotenih meril neželenih učinkov Nacionalnega onkološkega inštituta (NCI-CTCAE v4; “National Cancer Institute Common Terminology Criteria for Adverse Events.
Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth 
Pogosti kolitis n, suha usta kolitis n, suha usta kolitis n, suha usta
Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative. 
Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (98 %), je bilo 82 % PD-L1 pozitivnih in 18 % PD-L1 negativnih.
Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. 
Bolniki s pozitivnimi tumorskimi mutacijami EGFR ali ALK so pred prejemom zdravila KEYTRUDA morali prejeti tudi tarčno zdravljenje.
Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category 
Preglednica 29: Rezultati učinkovitosti v študiji KEYNOTE-426 po kategoriji tveganja IMDC
AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court 
AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland (MD) 21703 ZDA
No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively. 
Toksikološko pomembnih ugotovitev ni bilo, koncentracija, pri kateri niso opazili neželenih učinkov (no observed adverse effect level - NOAEL), je bila v obeh študijah ≥ 200 mg/kg, kar je 19-kratnik izpostavljenosti pri človeku ob odmerku 10 mg/kg oziroma 94-kratnik izpostavljenosti pri človeku ob odmerku 2 mg/kg.
Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids. 
Hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem brez prekinitve osnovnega zdravljenja in brez kortikosteroidov.
Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar. 
Po uporabi pembrolizumaba 200 mg na 3 tedne pri bolnikih s cHL je opažena mediana Cmin v stanju dinamičnega ravnovesja do 40 % višja kot pri drugih vrstah tumorjev, zdravljenih z enakim odmerkom, vendar pa je razpon glede na koncentracije podoben.
Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable. 
Absorpcija Pembrolizumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). 
Zapleti, vključno z boleznijo presadka proti gostitelju, pri ljudeh s presadkom kostnega mozga (matičnih celic) z uporabo donorskih matičnih celic (alogenska presaditev).
There are no notable differences in median Cmax between cHL and other tumour types. 
Glede mediane Cmax med cHL in drugimi vrstami tumorjev ni opaznih razlik.
Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated, and pembrolizumab should be withheld for adrenal insufficiency or symptomatic hypophysitis until the event is controlled with hormone replacement. 
Za zdravljenje adrenalne insuficience je treba uporabiti kortikosteroide in drugo nadomeščanje hormonov, kot je klinično indicirano; uporabo pembrolizumaba je treba v primeru adrenalne insuficience ali simptomatskega hipofizitisa prekiniti, dokler stanje ni urejeno z nadomeščanjem hormonov.
However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA. 
Vendar pa vam tekom zdravljenja z zdravilom KEYTRUDA zdravnik lahko predpiše kortikosteroide za zmanjšanje neželenih učinkov, ki bi jih lahko imeli zaradi zdravila KEYTRUDA.
If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered. 
V primeru ponovne uporabe aksitiniba se lahko razmisli o zmanjšanju odmerka v skladu s SmPC aksitiniba.
In patients with cHL (n=241) the incidence of hypothyroidism was 14.1% (all Grades) with 0.4% Grade 3. 
Pri bolnikih s cHL (n = 241) je bila pojavnost hipotiroidizma 14,1 % (vse stopnje) z 0,4 % 3. stopnje.
% with duration ≥ 6 months % with duration ≥ 9 months 
% s trajanjem ≥ 6 mesecev % s trajanjem ≥ 9 mesecev
People get KEYTRUDA after they have had surgery to remove melanoma to help prevent their cancer from coming back (adjuvant therapy). 
Bolniki prejmejo zdravilo KEYTRUDA po kirurški odstranitvi melanoma za preprečevanje ponovitve bolezni (adjuvantno zdravljenje).
There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1). 
Podatkov o varnosti in učinkovitosti zdravila KEYTRUDA pri bolnikih z očesnim melanomom je malo (glejte poglavje 5.1).
Randomisation to the chemotherapy and the chemotherapy-pembrolizumab arms remains open. 
Randomizacija v skupini s kemoterapijo in s kemoterapijo-pembrolizumabom ostaja odprta.
Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab. 
Pri bolnikih z EGFR aktivirajočo mutacijo ali ALK translokacijo je bolezen napredovala tudi med uporabo odobrenega zdravljenja za primer takšnih mutacij, preden so dobili pembrolizumab.
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes. 
Bolnike je treba spremljati glede hiperglikemije ali drugih znakov in simptomov sladkorne bolezni.
Patients should be monitored for suspected severe skin reactions and other causes should be excluded. 
Bolnike je treba spremljati glede hudih kožnih reakcij in izključiti druge vzroke.