natgillin/translations-raw huggingface dataset:
The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8). 
V kliničnih preskušanjih in v obdobju trženja zdravila so poročali o naslednjih klinično pomembnih imunsko pogojenih neželenih učinkih: uveitisu, artritisu, miozitisu, miokarditisu, pankreatitisu, Guillain-Barréjevem sindromu, miasteničnem sindromu, hemolitični anemiji, sarkoidozi in encefalitisu (glejte poglavji 4.2 in 4.8).
Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white. 
Od 834 bolnikov je bilo 60 % moških, 44 % starih ≥ 65 let (mediana starost je bila 62 let [razpon 18-89]) in 98 % je bilo belcev.
Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. 
Glede na izrazitost neželenega učinka je treba zadržati uporabo pembrolizumaba in uporabiti kortikosteroide.
Ninety percent of patients were treatment naïve, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. 
Devetdeset odstotkov bolnikov predhodno še ni bilo zdravljenih, 10 % pa jih je predhodno prejemalo adjuvantno ali neoadjuvantno kemoterapijo na osnovi platine.
KEYTRUDA 200 mg every 3 weeks n=514 
KEYTRUDA 200 mg vsake 3 tedne n = 514
A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells - MEL score) vs. PD-L1 negative. 
V okviru končne analize v študiji KEYNOTE-002 je bila opravljena analiza podskupin bolnikov, ki so bili PD-L1 pozitivni (izraženost PD-L1 pri ≥ 1 % tumorskih in s tumorjem povezanih imunskih celic v primerjavi z vsemi razpoložljivimi tumorskimi celicami - ocena po lestvici MEL), in PD-L1 negativni.
Of the patients who recovered, 92 (84%) were rechallenged with either pembrolizumab (3%) or axitinib (31%) monotherapy or with both (50%). 
Med bolniki, ki so okrevali, so pri 92 (84 %) ponovno uporabili ali pembrolizumab (3 %) ali aksitinib (31 %) kot samostojni zdravljenji ali kombinacijo obeh (50 %).
Secondary efficacy outcome measures were ORR and response duration. 
Sekundarni merili izida učinkovitosti sta bila ORR in trajanje odgovora.
The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function. 
Vpliv okvare ledvic na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago ali zmerno okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic.
Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment (see section 4.2). 
Pembrolizumaba niso raziskali pri bolnikih z zmerno ali hudo okvaro jeter (glejte poglavje 4.2).
Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8). 
Pembrolizumab je treba trajno ukiniti, če se kateri koli imunsko pogojeni neželeni učinek 3. stopnje znova pojavi oziroma če se pojavi toksičen imunsko pogojeni neželeni učinek 4. stopnje, razen v primeru endokrinopatij, ki so obvladljive z nadomeščanjem hormonov (glejte poglavji 4.2 in 4.8).
The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study. 
Učinkovitost pembrolizumaba v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom so raziskali v študiji KEYNOTE-407, randomizirani, dvojno slepi, multicentrični, s placebom nadzorovani študiji.
Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab. 
Bolniki na kemoterapiji, pri katerih je prišlo do neodvisno potrjenega napredovanja bolezni, so lahko prešli na zdravljenje s pembrolizumabom.
The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily. 
Varnost pembrolizumaba v kombinaciji z aksitinibom so ocenili v klinični študiji pri 429 bolnikih z napredovalim rakom ledvičnih celic, ki so prejemali 200 mg pembrolizumaba na 3 tedne in 5 mg aksitiniba dvakrat na dan.
Table 11 summarises efficacy results by PD-L1 expression and BRAF mutation status. 
Preglednica 11 prikazuje povzetek rezultatov učinkovitosti glede na izraženost PD-L1 in status mutacij BRAF.
The diluted solution must not be frozen. 
Razredčene raztopine ne smete zamrzniti.
th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm. 
Po razvrstitvi po 8. izdaji kriterijev AJCC je bil melanom pri skupno 82 bolnikih klasificiran kot stadij IIIA: pri 42 bolnikih v skupini s pembrolizumabom in 40 bolnikih v skupini s placebom; s skupno 13 RFS dogodki: 6 dogodki v skupini s pembrolizumabom in 7 dogodki v skupini s placebom.
Common aspartate aminotransferase increased, alanine aminotransferase increased, hypercalcaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased hypercalcaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased 
Pogosti zvišana aspartat-aminotransferaza, zvišana alaninaminotransferaza, hiperkalciemija, zvišana alkalna fosfataza v krvi, zvišan bilirubin v krvi, zvišan kreatinin v krvi hiperkalciemija, zvišana alanin-aminotransferaza, zvišana aspartataminotransferaza, zvišana alkalna fosfataza v krvi zvišana alkalna fosfataza v krvi, hiperkalciemija, zvišan bilirubin v krvi
Common hyponatraemia, hypokalaemia, hypocalcaemia hyponatraemia, hypocalcaemia hypokalaemia, hyponatraemia, hypocalcaemia 
Pogosti hiponatriemija, hipokaliemija, hipokalciemija hiponatriemija, hipokalciemija hipokaliemija, hiponatriemija, hipokalciemija
ORR difference, % (95% CI) 
razlika ORR, % (95 % IZ)
KEYNOTE-054: Placebo-controlled trial for the adjuvant treatment of patients with completely resected melanoma 
KEYNOTE-054: S placebom nadzorovano preskušanje adjuvantnega zdravljenja bolnikov s popolnoma kirurško odstranjenim melanomom
- If you are a woman who could become pregnant, you must use adequate birth control while you are being treated with KEYTRUDA and for at least 4 months after your last dose. 
- Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom KEYTRUDA in vsaj še
Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy. 
O hipotiroidizmu so pogosteje poročali pri bolnikih s HNSCC, ki so se predhodno zdravili z obsevanjem.
KEYNOTE-361 is an ongoing Phase III, randomised, controlled, open-label clinical trial of pembrolizumab with or without platinum-based combination chemotherapy versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. 
KEYNOTE-361 je potekajoče, randomizirano, kontrolirano, odprto klinično preskušanje III. faze pembrolizumaba s kombinirano kemoterapijo na osnovi platine ali brez takšne kemoterapije v primerjavi s kemoterapijo kot prvo linijo zdravljenja pri bolnikih z napredovalim ali metastatskim urotelijskim rakom.
In patients with ALT ≥ 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. 
Pri bolnikih z vrednostjo ALT ≥ 3-kratno ZNM (2. do 4. stopnja, n = 116) se je vrednost ALT v 94 % znižala na 0. ali 1. stopnjo.
• Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. 
• Potrebno količino do 4 ml (100 mg) koncentrata povlecite iz viale in jo prenesite v intravensko vrečko, ki vsebuje natrijev klorid 9 mg/ml (0,9 %) ali glukozo 50 mg/ml (5 %), da pripravite razredčeno raztopino s končno koncentracijo od 1 do 10 mg/ml.
Sixty-one percent of patients had received Auto-SCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 36% of patients had prior radiation therapy. 
Enainšestdeset odstotkov bolnikov je prejelo avto-SCT, 38 % jih ni bilo primernih za presaditev, 17 % jih predhodno ni prejemalo brentuksimaba vedotina in 36 % bolnikov je predhodno prejelo radioterapijo.
Pembrolizumab is most commonly associated with immune-related adverse reactions. 
Pembrolizumab je najpogosteje povezan z imunsko pogojenimi neželenimi učinki.
Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian. 
Pri 370 bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, so bile izhodiščne značilnosti: mediana starost 74 let (82 % starih 65 let ali več), 77 % moških ter 89 % belcev in 7 % Azijcev.
In this patient population, the most frequent adverse reactions were diarrhoea (54%), hypertension (45%), fatigue (38%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysaesthesia syndrome (28%), nausea (28%), ALT increased (27%), AST increased (26%), dysphonia (25%), cough (21%), and constipation (21%). 
V tej populaciji bolnikov so bili najpogostejši neželeni učinki diareja (54 %), hipertenzija (45 %), utrujenost (38 %), hipotiroidizem (35 %), zmanjšan apetit (30 %), sindrom palmarno-plantarne eritrodisestezije (28 %), navzea (28 %), zvišanje vrednosti ALT (27 %), zvišanje vrednosti AST (26 %), disfonija (25 %), kašelj (21 %) in zaprtost (21 %).
There is no information on overdose with pembrolizumab. 
Informacij o prevelikem odmerjanju pembrolizumaba ni.
• If ALT or AST ≥ 3 times ULN but < 10 times ULN without concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1. 
• Če je ALT ali AST ≥ 3-krat nad ZNM, a < 10-krat nad ZNM, in celokupni bilirubin ob tem ni ≥ 2-krat nad ZNM, je treba zadržati uporabo tako zdravila KEYTRUDA kot aksitiniba, dokler se neželeni učinki ne zmanjšajo na stopnjo 0-1.
Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy. 
Štiriinosemdeset odstotkov jih je bilo neodzivnih na vsaj eno predhodno zdravljenje, vključno s 35 %, ki so bili neodzivni na zdravljenje prve linije.
In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. 
Pri bolnikih s HNSCC, ki so prejemali pembrolizumab v kombinaciji s kemoterapijo s platino in 5-fluorouracilom (n = 276), je bila pojavnost hipotiroidizma 15,2 %, vsi primeri so bili 1. ali 2. stopnje.
The Kaplan-Meier curve based on the final analysis for OS is shown in Figure 12. 
Kaplan-Meierjeva krivulja na podlagi končne analize za OS je prikazana na sliki 12.
Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white. 
Od 540 bolnikov je bilo 61 % moških, 43 % starih ≥ 65 let (mediana starost je bila 62 let [razpon 15-89]) in 98 % je bilo belcev.
Adverse reactions known to occur with pembrolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy. 
Pri kombiniranem zdravljenju se lahko pojavijo neželeni učinki, za katere je znano, da se lahko pojavijo pri samostojnem zdravljenju s pembrolizumabom ali kemoterapijo, čeprav o teh neželenih učinkih v kliničnih preskušanjih kombiniranega zdravljenja morda niso poročali.
Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%). 
Med razlogi, zaradi katerih bolniki niso bili primerni za zdravljenje s cisplatinom, so bili: izhodiščni očistek kreatinina < 60 ml/min (50 %), ocena zmogljivosti po ECOG lestvici 2 (32 %), ocena zmogljivosti po ECOG lestvici 2 in izhodiščni očistek kreatinina < 60 ml/min (9 %) in drugo (srčno popuščanje v razredu III, periferna nevropatija 2. stopnje ali več in izguba sluha 2. stopnje ali več; 9 %).
The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild hepatic impairment (as defined using the US National Cancer Institute criteria of hepatic dysfunction) compared to patients with normal hepatic function. 
Vpliv okvare jeter na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago okvaro jeter (opredeljeno po merilih ameriškega Nacionalnega onkološkega inštituta za moteno delovanje jeter) v primerjavi z bolniki z normalnim delovanjem jeter.
The primary efficacy outcome measures were progression free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS). 
Primarni merili izida učinkovitosti sta bili preživetje brez napredovanja bolezni (PFS - progression free survival, ocenjeno po integrirani radiološki in onkološki presoji [IRO] na podlagi meril RECIST, različica 1.1) ter celokupno preživetje (OS - overall survival).
For severe infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2). 
V primeru hudih z infuzijo povezanih reakcij je treba infundiranje ustaviti in pembrolizumab trajno ukiniti (glejte poglavje 4.2).
#) of patients with duration ≥ 12 months 
#) bolnikov s trajanjem ≥ 12 mesecev
Chemotherapy (n=137) 
kemoterapija (n = 137)
• If ALT or AST ≥ 10 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. 
• Če je ALT ali AST ≥ 10-krat nad ZNM, ali če je > 3-krat nad ZNM, in je ob tem celokupni bilirubin ≥ 2-krat nad ZNM, je treba trajno ukiniti tako zdravilo KEYTRUDA kot aksitinib in razmisliti o zdravljenju s kortikosteroidi.
Based on a recommendation by an external Data Monitoring Committee, the accrual in the pembrolizumab monotherapy arm was stopped for patients whose tumours express PD-L1 with a CPS < 10. 
Na podlagi priporočila zunanjega Odbora za spremljanje podatkov (Data Monitoring Committee) se je v skupino z monoterapijo s pembrolizumabom ustavilo vključevanje bolnikov, pri katerih tumorji izražajo PD-L1 s CPS < 10.
Other medicines and KEYTRUDA Tell your doctor - If you are taking other medicines that make your immune system weak. 
Zdravniku povejte: - če jemljete druga zdravila, ki lahko oslabijo imunski sistem.
An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or ≥ 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDx 
V študiji KEYNOTE-052 je bila narejena analiza pri bolnikih, ki so imeli tumorje z izraženostjo PD-L1 s CPS < 10 (n = 251; 68 %) ali ≥ 10 (n = 110; 30 %) na podlagi testa PD-L1, opravljenega z IHC 22C3 pharmDx
Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited. 
Podatkov o varnosti pembrolizumaba pri bolnikih, starih ≥ 75 let, ki so zdravilo prejemali zaradi adjuvantnega zdravljenja melanoma, je malo.
Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal. 
Zapleti alogenske HSCT pri klasičnem Hodgkinovem limfomu Med 23 bolniki s cHL, pri katerih je bila po zdravljenju s pembrolizumabom opravljena alogenska HSCT, se je pri 6 bolnikih (26 %) razvila GVHD, v enem primeru s smrtnim izidom, pri 2 bolnikih (9 %) pa se je razvila huda VOD jeter (po pripravi bolnika za presaditev z zmanjšano intenzivnostjo), v enem primeru s smrtnim izidom.
Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison. 
Rezultati učinkovitosti za celokupno preživetje so bili na podlagi primerjave med skupinami skladni ne glede na starost tumorskega vzorca (nov ali arhivski).
Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma. 
Dvainosemdeset odstotkov je imelo M1c stadij, 73 % je imelo predhodno vsaj dve in 32 % je imelo predhodno tri ali več sistemskih zdravljenj za napredovali ipilimumab:
For patients with Grade 3 or Grade 4 endocrinopathy that improved to Grade 2 or lower and is controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. 
Pri bolnikih z endokrinopatijo 3. ali 4. stopnje, ki se izboljša na 2. ali nižjo stopnjo in se uredi z nadomeščanjem hormonov, se po predhodnem postopnem zmanjševanju odmerka kortikosteroida (če je potrebno) lahko razmisli o nadaljevanju uporabe pembrolizumaba, če je to indicirano.
Based on patients with a best overall response as confirmed complete or partial response Based on Kaplan-Meier estimation 
Na podlagi bolnikov z najboljšim celokupnim odgovorom, potrjenim kot popolni ali delni odgovor Na podlagi Kaplan-Meierjeve ocene
Of the 89 patients receiving 2 mg/kg of pembrolizumab who were previously treated with ipilimumab, 53% were male, 33% were ≥ 65 years of age and the median age was 59 years (range 18-88). 
Od 89 bolnikov, ki so prejemali 2 mg/kg pembrolizumaba in so bili predhodno zdravljeni z ipilimumabom, je bilo 53 % moških, 33 % starih ≥ 65 let, mediana starost pa je bila 59 let (razpon: 18-88).
Figure 9: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407 
Slika 9: Kaplan-Meierjeva krivulja celokupnega preživetja v študiji KEYNOTE-407
Hypothyroidism resolved in 153 (23.7%) patients, 10 with sequelae. 
Hipotiroidizem je izzvenel pri 153 bolnikih (23,7 %), pri 10 je pustil posledice.
Assessment of tumour status was performed every 9 weeks. 
Stanje tumorja so ocenjevali na 9 tednov.
The median area under the concentration time curve at steady state over 3 weeks (AUC0-3weeks) was 794 mcg∙day/mL at a dose of 2 mg/kg every 3 weeks and 1,053 mcg∙day/mL at a dose of 200 mg every 3 weeks. 
Mediana površina pod krivuljo koncentracije po času v stanju dinamičnega ravnovesja v obdobju 3 tednov (AUC0-3tedne) je bila 794 µg∙dan/ml ob odmerku 2 mg/kg na 3 tedne in 1.053 µg∙dan/ml ob odmerku 200 mg na 3 tedne.
* Cetuximab, platinum, and 5-FU 
* Cetuksimab, platina in 5-fluorouracil
Uncommon uveitis uveitis 
Občasni uveitis uveitis
Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. 
Pembrolizumab se iz obtoka odstrani s katabolizmom, zato presnovnih medsebojnih delovanj zdravil ni pričakovati.
Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. 
Štiriinosemdeset odstotkov je imelo M1c stadij in 8 % bolnikov je imelo v anamnezi metastaze v možganih.
* Based on the stratified Cox proportional hazard model NR = not reached 
* Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti ND = ni dosežena
Use of pembrolizumab in urothelial cancer for patients who are considered ineligible for cisplatincontaining chemotherapy and whose tumours express PD-L1 with CPS ≥ 10 
Uporaba pembrolizumaba pri bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, in pri katerih tumorji izražajo PD-L1 s CPS ≥ 10
The median follow-up time was 10.5 months (range: 0.2 to 20.4 months). 
Mediani čas spremljanja je znašal 10,5 meseca (razpon: 0,2 do 20,4 meseca).
The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC. 
Študija ni vključevala bolnikov z rakom nazofarinksa, aktivno avtoimunsko boleznijo, ki je v zadnjih 2 letih zahtevala sistemsko zdravljenje, bolnikov z zdravstvenim stanjem, ki je zahtevalo imunosupresivno zdravljenje, in bolnikov, ki so se predhodno zdravili s 3 ali več režimi sistemskega zdravljenja ponovljenega in/ali metastatskega HNSCC.
Pembrolizumab should be withheld for Grade ≥ 3 until recovery to Grade ≤ 1 hyperthyroidism. 
Uporabo pembrolizumaba je treba v primeru hipertiroidizma ≥ 3. stopnje zadržati, dokler se ne izboljša na ≤ 1. stopnjo.
Table 20: OS by PD-L1 Expression 
Preglednica 20: OS glede na izraženost PD-L1
• Withdraw the required volume up to 2 mL (50 mg) of KEYTRUDA and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. 
• Potrebno količino do 2 ml (50 mg) zdravila KEYTRUDA povlecite iz viale in jo prenesite v intravensko vrečko, ki vsebuje natrijev klorid 9 mg/ml (0,9 %) ali glukozo 50 mg/ml (5 %), da pripravite razredčeno raztopino s končno koncentracijo od 1 do 10 mg/ml.
Common thrombocytopaenia, lymphopaenia febrile neutropaenia, leukopaenia, lymphopaenia anaemia, neutropaenia, leukopaenia, thrombocytopaenia 
Pogosti trombocitopenija, limfopenija febrilna nevtropenija, levkopenija, limfopenija anemija, nevtropenija, levkopenija, trombocitopenija
The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. 
Pri teh bolnikih je treba pretehtati korist zdravljenja s pembrolizumabom in tveganje za morebitno zavrnitev organa.
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults (see section 5.1). 
Zdravilo KEYTRUDA je v kombinaciji z aksitinibom indicirano za prvo linijo zdravljenja napredovalega raka ledvičnih celic (RCC - renal cell carcinoma) pri odraslih (glejte poglavje 5.1).
Urothelial Carcinoma 
Urotelijski rak
Uncommon hepatitis hepatitis 
Občasni hepatitis hepatitis
powder for concentrate for solution for infusion 1 vial 
prašek za koncentrat za raztopino za infundiranje 1 viala
Boehringer Ingelheim (BIB) Pharma GmbH & Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany 
KG Birkendorfer Straße 65 88397 Biberach an der Riss Nemčija
Patients on chemotherapy who experienced independently verified progression of disease after the first scheduled disease assessment were able to crossover and receive 2 mg/kg or 10 mg/kg of pembrolizumab every 3 weeks in a double-blind fashion. 
Bolniki na kemoterapiji, pri katerih je po prvi predvideni oceni bolezni po 12 tednih zdravljenja prišlo do napredovanja bolezni, ki je bilo neodvisno potrjeno, so lahko prešli na dvojno slepo prejemanje 2 mg/kg ali 10 mg/kg pembrolizumaba na 3 tedne.
Vascular disorders Very common hypertension 
Žilne bolezni Zelo pogosti hipertenzija
erythema, dry skin severe skin reactions s, dermatitis acneiform, dermatitis, dry skin, alopecia, eczema, erythema 
eritem, suha koža hude kožne reakcije s, akneiformni dermatitis, dermatitis, suha koža, alopecija, ekcem, eritem
- Do not breast-feed while taking KEYTRUDA. 
- Med uporabo zdravila KEYTRUDA ne dojite.