natgillin/translations-raw huggingface dataset:
Sub-population analyses 
Analize podpopulacij
KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment. 
Zdravilo KEYTRUDA boste prejeli v bolnišnici ali ambulanti pod nadzorom zdravnika z izkušnjami pri zdravljenju raka.
28.0 (14, not available) 
28,0 (14, ni na voljo)
What KEYTRUDA is and what it is used for 
Kaj je zdravilo KEYTRUDA in za kaj ga uporabljamo
In 20 subjects with ocular melanoma included in KEYNOTE-001, no objective responses were reported; stable disease was reported in 6 patients. 
Med 20 preiskovanci z očesnim melanomom, ki so bili vključeni v študijo KEYNOTE-001, ni bilo objektivnega odgovora; o stabilni bolezni so poročali pri 6 bolnikih.
Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. 
Na podlagi podatkov o varnosti, ki so na voljo za cHL in druge vrste tumorjev, te razlike niso klinično pomembne.
The safety profile in these paediatric patients was generally similar to that seen in adults treated with pembrolizumab. 
Varnostni profil je bil pri teh pediatričnih bolnikih na splošno podoben kot pri odraslih, zdravljenih s pembrolizumabom.
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. 
Opaženi so bili netipični odgovori (tj. prehodno začetno povečanje velikosti tumorja ali majhne nove lezije v prvih nekaj mesecih zdravljenja, čemur je sledilo zmanjšanje tumorja).
Liver enzymes should be monitored before initiation of and periodically throughout treatment. 
Jetrne encime je treba spremljati pred začetkom zdravljenja in periodično med zdravljenjem.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
(n=84), or vinflunine 320 mg/m 
(n = 84) ali vinflunin 320 mg/m
BRAF mutation status in melanoma 
Status mutacije BRAF pri melanomu
The Patient Information Brochure and Patient Alert Card shall contain the following key elements: 
Vodnik za bolnike in opozorilna kartica za bolnika morata vsebovati naslednje ključne elemente:
Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. 
Povečanje odmerka aksitiniba na 10 mg dvakrat na dan je bilo dovoljeno z uporabo enakih meril.
• KEYTRUDA is for single use only. 
• Zdravilo KEYTRUDA je samo za enkratno uporabo.
These reactions are presented by system organ class and by frequency. 
Ti učinki so prikazani po organskih sistemih in pogostnosti.
If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. 
Če so viale in/ali intravenske vrečke shranjene v hladilniku, jih morate pustiti, da pred uporabo dosežejo sobno temperaturo.
The MAH shall ensure that in each Member State where KEYTRUDA is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe and use KEYTRUDA have access to/are provided with the patient educational material. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo KEYTRUDA trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali zdravilo KEYTRUDA, imeli dostop do/prejeli izobraževalno gradivo za bolnike.
Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. 
Devetinpetdeset odstotkov bolnikov z zvišano vrednostjo ALT je prejemalo sistemske kortikosteroide.
Table 27 summarises the key efficacy measures for the TPS ≥ 50% population. 
Preglednica 27 povzema ključna merila učinkovitosti za TPS ≥ 50 % populacijo.
KEYTRUDA is used in adults to treat: 
Zdravilo KEYTRUDA uporabljamo pri odraslih za zdravljenje:
Efficacy and safety data from patients ≥ 75 years are limited. 
Podatkov o varnosti in učinkovitosti pri bolnikih, starih ≥ 75 let, je malo.
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. 
Zdravljenje morajo uvesti in nadzorovati zdravniki specialisti z izkušnjami pri zdravljenju raka.
KEYTRUDA may be given in combination with other anti-cancer medicines. 
Zdravilo KEYTRUDA se lahko uporablja v kombinaciji z drugimi zdravili proti raku.
Exclusion criteria were similar to those of KEYNOTE-002. 
Merila za nevključitev so bila podobna kot v študiji KEYNOTE-002.
Examples of these may include corticosteroids, such as prednisone. 
Primer takšnih zdravil so kortikosteroidi, na primer prednizon.
The safety and efficacy of KEYTRUDA in children below 18 years of age have not yet been established. 
Varnost in učinkovitost zdravila KEYTRUDA pri otrocih, starih manj kot 18 let, še nista bili dokazani.
- It is not known if KEYTRUDA passes into your breast milk. 
- Ni znano, ali zdravilo KEYTRUDA prehaja v materino mleko.
18.9 (11, not available) 
18,9 (11, ni na voljo)
Participants were enrolled across 28 tumour types by primary diagnosis. 
Vključeni preiskovanci so imeli kot primarno diagnozo 28 vrst tumorjev.
It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with KEYTRUDA. 
Vsebuje tudi opozorilo, da si zabeležijo kontaktne podatke zdravnika in opozorilo drugim zdravnikom, da se bolnik zdravi z zdravilom KEYTRUDA.
The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. 
Pot PD-1/PD-L1 je domnevno povezana z vzdrževanjem tolerance za plod v času nosečnosti.
Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady state is small (~6.0 L; CV: 20%). 
Skladno z majhno zunajžilno porazdelitvijo je volumen porazdelitve pembrolizumaba v stanju dinamičnega ravnovesja majhen (~6,0 l, KV: 20 %).
Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. 
Pembrolizumaba se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje s pembrolizumabom.
Do not store any unused portion of the infusion solution for reuse. 
Neporabljenega ostanka raztopine za infundiranje ne shranite za ponovno uporabo.
If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2°C to 8°C. 
Če ni uporabljena takoj, sta kemična in fizikalna stabilnost zdravila KEYTRUDA med uporabo dokazani za 96 ur na temperaturi 2 °C do 8 °C.
As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. 
Kot je pričakovano za protitelo, se pembrolizumab ne veže specifično na beljakovine v plazmi.
In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature. 
V 1-mesečni in 6-mesečni toksikološki študiji ponavljajočih se odmerkov pri opicah ni bilo opaznih učinkov na spolne organe samcev in samic, vendar številne živali v teh študijah niso bile spolno zrele.
The relationship between body weight and clearance supports the use of either fixed dose or body weight-based dosing to provide adequate and similar control of exposure. 
Razmerje med telesno maso in očistkom potrjuje, da tako uporaba fiksnega odmerka kot odmerka glede na telesno maso zagotavljata ustrezno in podobno obvladovanje izpostavljenosti.
Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8). 
Dokler ne bo na voljo več podatkov, je treba pri vsakem bolniku posebej skrbno pretehtati možne koristi HSCT in možno večje tveganje za pojav zapletov, povezanih s presaditvijo (glejte poglavje 4.8).
Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases. 
Dejavnika, povezana z zgodnjimi smrtmi, sta bila hitro napredujoča bolezen med predhodnim zdravljenjem s platino in metastaze v jetrih.
PD-L1 status in melanoma 
Status PD-L1 pri melanomu
Immune system disorders Common infusion related reaction infusion related reaction a infusion related reaction 
Bolezni imunskega sistema Pogosti z infuzijo povezana reakcija z infuzijo povezana reakcija z infuzijo povezana reakcija
What you need to know before you are given KEYTRUDA 
Kaj morate vedeti, preden boste prejeli zdravilo KEYTRUDA
BRAF wild type 
divji tip BRAF
Grade 2 with creatinine > 1.5 to ≤ 3 times upper limit of normal (ULN) 
2. stopnja s kreatininom > 1,5- do ≤ 3-krat nad zgornjo normalno mejo (ZNM)
Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients. 
Zdravljenje s pembrolizumabom lahko poveča tveganje za zavrnitev pri prejemnikih presadkov čvrstih organov.
Table 1: Recommended treatment modifications for KEYTRUDA 
Preglednica 1: Priporočene prilagoditve zdravljenja z zdravilom KEYTRUDA
This can affect your ability to drive or to use machines. 
To lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
Dose delay or discontinuation (see also section 4.4) 
Odložitev odmerka ali ukinitev zdravljenja (glejte tudi poglavje 4.4)
Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. 
Bolnike je treba spremljati glede znakov in simptomov adrenalne insuficience in hipofizitisa (vključno s hipopituitarizmom) in izključiti druge vzroke.
What KEYTRUDA is and what it is used for What you need to know before you are given KEYTRUDA How you are given KEYTRUDA Possible side effects 
Kaj je zdravilo KEYTRUDA in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo KEYTRUDA Kako boste prejeli zdravilo KEYTRUDA Možni neželeni učinki
These results indicate a potential risk, based on its mechanism of action, that administration of pembrolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth. 
Ti rezultati kažejo na možno tveganje, da bi uporaba pembrolizumaba med nosečnostjo zaradi njegovega mehanizma delovanja lahko povzročila okvaro ploda, vključno z večjimi deleži splavov ali mrtvorojenosti.
Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. 
Ženske v rodni dobi morajo med zdravljenjem s pembrolizumabom in vsaj še 4 mesece po zadnjem odmerku pembrolizumaba uporabljati učinkovito kontracepcijo.
Pembrolizumab may have a minor influence on the ability to drive and use machines. 
Pembrolizumab ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). 
Za obe zdravili je treba upoštevati navodila za ukrepanje (glejte poglavje 4.2 in SmPC aksitiniba).
Not reached (0.0+, 45.6+) 
ni dosežena (0,0+; 45,6+)
Grades 3 or 4 myocarditis Grades 3 or 4 encephalitis Grades 3 or 4 Guillain-Barré syndrome 
miokarditis 3. ali 4. stopnje encefalitis 3. ali 4. stopnje Guillain-Barréjev sindrom 3. ali 4. stopnje
Data from patients ≥ 65 years are too limited to draw conclusions on cHL population (see section 5.1). 
Podatkov pri bolnikih, starih ≥ 65 let, je premalo, da bi lahko podali zaključke glede populacije s cHL (glejte poglavje 5.1).
Your doctor will monitor you for signs and symptoms, which may include skin rash, liver inflammation, abdominal pain, or diarrhoea. 
Zdravnik vas bo spremljal glede znakov in simptomov, ki lahko vključujejo izpuščaj na koži, vnetje jeter, bolečine v trebuhu ali drisko.
The potential risk of gastrointestinal perforation should be taken into consideration. 
Upoštevati je treba morebitno tveganje za perforacije v prebavilih.
These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. 
Ti študiji sta zajeli bolnike, pri katerih ASCT in BV nista bila uspešna, bolnike, ki niso bili primerni za ASCT, ker niso mogli doseči popolne ali delne remisije z rešilno kemoterapijo in zdravljenje z BV ni bilo uspešno, ali ASCT ni bila uspešna in niso prejeli BV.
• The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first 
• Opozorilo, naj bolniki ne poskušajo sami zdraviti katerih koli simptomov, ne da bi se posvetovali z zdravnikom
Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. 
Pet preiskovancev v študiji ni bilo primernih za ASCT zaradi drugih razlogov, ne zaradi neuspeha rešilne kemoterapije.
The European Medicines Agency has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s pembrolizumabom za eno ali več podskupin pediatrične populacije za zdravljenje Hodgkinovega limfoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients with mild or moderate infusion reaction may continue to receive pembrolizumab with close monitoring; premedication with antipyretic and antihistamine may be considered. 
Bolniki z blago ali zmerno z infuzijo povezano reakcijo lahko pembrolizumab še naprej prejemajo pod skrbnim nadzorom; razmisliti je treba o premedikaciji z antipiretikom in antihistaminikom.
Prior to launch of KEYTRUDA in each Member State the 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 KEYTRUDA na trg v vsaki posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vseh drugih vidikih programa.
Response was assessed in KN087 and KN013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at week 12. 
Odgovor so v KN087 ocenjevali na 12 tednov in v KN013 na 8 tednov; prva načrtovana poizhodiščna ocena je bila v 12. tednu.
Chemotherapy OS by PD-L1 Expression Number of Events (number of patients)* 
izraženost PD-L1 pembrolizumab kemoterapija OS glede na izraženost PD-L1 število dogodkov (število bolnikov)*
Table 19 summarises the key efficacy measures for the ITT population at the final analysis. 
Preglednica 19 povzema ključna merila učinkovitosti za populacijo ITT pri končni analizi.
Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. 
Predhodno zdravljenje je obsegalo dvojno shemo s platino (100 %); bolniki so prejeli eno (69 %) ali dve ali več (29 %) linij zdravljenja.
There were no Grade 5 hepatic events. 
Jetrnih učinkov 5. stopnje ni bilo.
• Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA. 
• Aseptično dodajte 2,3 ml vode za injekcije, da dobite raztopino zdravila KEYTRUDA 25 mg/ml (pH 5,2-5,8).
cardiac arrhythmia (including atrial fibrillation) 
motnja srčnega ritma (vključno z atrijsko fibrilacijo)
Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”). 
Randomizacija je bila stratificirana po kategorijah tveganja (ugodna kategorija v primerjavi s srednjo in v primerjavi s slabo) in po geografskem področju (Severna Amerika v primerjavi z Zahodno Evropo v primerjavi s "preostalim svetom").
The same scoring system was used for metastatic melanoma (MEL score). 
Sistem točkovanja je enak kot je bil uporabljen pri metastatskem melanomu (ocena po lestvici MEL).
All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. 
Vsi predpisovalci zdravila KEYTRUDA morajo biti seznanjeni z informacijami za zdravnike in navodili za ukrepanje.
BRAF mutations were reported in 302 (36%) patients. 
O mutacijah BRAF so poročali pri 302 bolnikih (36 %).
The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. 
Uporabi sistemskih kortikosteroidov ali imunosupresivov pred uvedbo pembrolizumaba se je treba izogibati, ker lahko vplivajo na farmakodinamično aktivnost in učinkovitost pembrolizumaba.
For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured. 
V primeru suma na imunsko pogojene neželene učinke je treba poskrbeti za ustrezno oceno za potrditev etiologije oziroma izključitev drugih vzrokov.
KEYTRUDA must be administered by intravenous infusion over 30 minutes. 
Zdravilo KEYTRUDA je treba aplicirati v intravenski infuziji v 30 minutah.
Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel. 
Petintrideset odstotkov je imelo izraženost PD-L1 TPS < 1 % [negativno], 19 % je bilo vzhodnih Azijcev in 60 % je prejemalo paklitaksel.
Of the 154 patients, 134 were enrolled with solid tumours, 18 with Hodgkin lymphoma, and 2 with other lymphomas. 
Od 154 bolnikov je bilo 134 vključenih s čvrstimi tumorji, 18 s Hodgkinovim limfomom in 2 z drugimi limfomi.
• Slowly swirl the vial to allow reconstitution of the lyophilised powder. 
• Vialo počasi vrtite, da se liofiliziran prašek lahko raztopi.
In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis. 
Dokler takšnih podatkov ni, je treba pembrolizumab v tej populaciji uporabljati previdno, po skrbni oceni možnih koristi in tveganj za posameznega bolnika.
Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity. 
Uporabo aksitiniba je bilo mogoče prekiniti ali odmerek zmanjšati na 3 mg dvakrat na dan in nato na 2 mg dvakrat na dan, da bi obvladali toksične učinke.
Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN 
2. stopnja z aspartat-aminotransferazo (AST) ali alanin-aminotransferazo (ALT) > 3- do 5-krat nad ZNM, ali s celokupnim bilirubinom > 1,5- do 3-krat nad ZNM
• The importance of carrying the Patient Alert Card at all times and to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals). 
• Opozorilo, naj imajo opozorilno kartico za bolnika ves čas pri sebi in jo pokažejo ob vseh obiskih pri drugih zdravnikih (npr. na urgenci).
Upon improvement to Grade ≤ 1, corticosteroid taper should be initiated and continued over at least 1 month. 
Po izboljšanju na ≤ 1. stopnjo je treba začeti postopoma zmanjševati odmerek kortikosteroida v obdobju vsaj 1 meseca.
Hepatitis resolved in 36 patients. 
Izzvenel je pri 36 bolnikih.
Not reached (2.7, 13.8+) 
ni dosežena (2,7; 13,8+)
Secondary efficacy outcome measures were duration of response, PFS, and OS. Table 21 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients. 
Sekundarna merila izida učinkovitosti so bila trajanje odgovora, PFS in OS. Preglednica 21 povzema ključna merila učinkovitosti v raziskovani populaciji študije ob končni analizi na podlagi medianega časa spremljanja 11,4 meseca (v razponu od 0,1 do 41,2 meseca) za vse bolnike.
The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. 
Ključni merili primernosti za vključitev v to študijo sta bili metastatski ploščatocelični NSCLC, ne glede na stanje izraženosti PD-L1 tumorja, in brez predhodnega sistemskega zdravljenja metastatske bolezni.
Based on method by Miettinen and Nurminen 
Na podlagi metode Miettinena in Nurminena
• Description of the main signs or symptoms of the irARs and the importance of notifying their treating physician immediately if symptoms occur 
• Opis glavnih znakov in simptomov imunsko pogojenih neželenih učinkov in opozorilo, da zdravnika obvestijo takoj, ko se simptomi pojavijo
The major efficacy outcome measures (ORR and CRR) were assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria. 
Glavni merili izida učinkovitosti (ORR in CRR) sta bili ocenjeni s slepim neodvisnim centralnim pregledom na podlagi revidiranih meril IWG (International Working Group) iz leta 2007.
- It is important that you keep the Alert Card with you during treatment. 
- Pomembno je, da imate opozorilno kartico ves čas pri sebi.
Metabolism and nutrition disorders Very common decreased appetite hypokalaemia, decreased appetite decreased appetite 
Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita hipokaliemija, zmanjšanje apetita zmanjšanje apetita
- if you are allergic to pembrolizumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). 
Zdravila KEYTRUDA ne smete prejeti - če ste alergični na pembrolizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 "Vsebina pakiranja in dodatne informacije").
Patients must have received first line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression ≤ 12 months following completion of therapy. 
Bolniki so morali predhodno prejemati prvo linijo zdravljenja, ki je vključevala platino, za lokalno napredovalo/metastatsko bolezen ali kot neoadjuvantno/adjuvantno zdravljenje s ponovitvijo/napredovanjem ≤ 12 mesecev po dokončanju zdravljenja.
If you miss an appointment to get KEYTRUDA - Call your doctor right away to reschedule your appointment. 
Če izpustite obisk pri zdravniku, ko bi morali prejeti zdravilo KEYTRUDA - Takoj pokličite zdravnika in se dogovorite za obisk.
The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild hepatic impairment and tumour burden. 
Naslednji dejavniki niso klinično pomembno vplivali na očistek pembrolizumaba: starost (razpon od 15 do 94 let), spol, rasa, blaga ali zmerna okvara ledvic, blaga okvara jeter in tumorsko breme.
The reconstituted or diluted solution must not be frozen. 
Pripravljene ali razredčene raztopine ne smete zamrzniti.
For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year. 
Pri bolnikih, ki so dokončali 24-mesečno zdravljenje, ali pa je bil dosežen popolni odgovor, se je zdravljenje s pembrolizumabom lahko ponovno uvedlo, če je bolezen napredovala, bolniki pa so se lahko zdravili do 1 dodatnega leta.
The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. 
Učinkovitost in varnost pembrolizumaba pri bolnikih s tumorji brez izraženosti PD-L1 nista bili dokazani.
The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. 
Vplive različnih sospremenljivk na farmakokinetiko pembrolizumaba so ocenili v populacijskih farmakokinetičnih analizah.
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. 
V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati glede znakov in simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.