natgillin/translations-raw huggingface dataset:
Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. 
Znano je, da humani imunoglobulini G4 (IgG4) prehajajo skozi placentno pregrado, in ker je pembrolizumab IgG4, obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
Pembrolizumab concentrations with weight-based dosing at 2 mg/kg every 3 weeks in paediatric patients (2 to 17 years) are comparable to those of adults at the same dose. 
Koncentracije pembrolizumaba med odmerjanjem na podlagi telesne mase 2 mg/kg vsake 3 tedne so pri pediatričnih bolnikih (starih od 2 do 17 let) primerljive s tistimi pri odraslih med uporabo enakega odmerka.
Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial. 
Bolniki z aktivnim neinfekcijskim pnevmonitisom, opravljeno alogensko presaditvijo v zadnjih 5 letih (ali > 5 let, toda z GVHD), aktivno avtoimunsko boleznijo ali zdravstvenim stanjem, ki je zahtevalo imunosupresijo, niso bili vključeni v nobeno od raziskav.
The reconstituted vials and/or diluted intravenous bags may be stored for a cumulative time of up to 96 hours in a refrigerator (2°C - 8°C). 
Pripravljene viale in/ali vrečke z razredčeno raztopino za intravensko uporabo so lahko shranjene v hladilniku (2 °C - 8 °C) do skupno 96 ur.
Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. 
Kortikosteroide je mogoče uporabiti tudi kot premedikacijo, če je pembrolizumab uporabljen v kombinaciji s kemoterapijo, kot antiemetično profilakso in/ali za ublažitev neželenih učinkov, povezanih s kemoterapijo.
Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2). 
Na podlagi modeliranja in simulacije razmerja odmerek/izpostavljenost za učinkovitost in varnost pembrolizumaba ni klinično pomembnih razlik v učinkovitosti ali varnosti pembrolizumaba pri samostojnem zdravljenju z odmerki 200 mg na 3 tedne, 2 mg/kg na 3 tedne in 400 mg na 6 tednov (glejte poglavje 4.2).
Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance. 
Katabolizem pembrolizumaba poteka po nespecifičnih poteh; presnova ne pripomore k njegovemu očistku.
KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih.
Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate 
razmerje ogroženosti (HR)* (98 % IZ) vrednost p (stratificirani logrank) RFS po 6 mesecih delež RFS RFS po 12 mesecih delež RFS RFS po 18 mesecih delež RFS
Not statistically significant after adjustment for multiplicity Based on patients with a best overall response as confirmed complete or partial response from the final analysis 
Ni statistično značilno po prilagoditvi glede multiplikativnosti Na podlagi bolnikov z najboljšim celokupnim odgovorom, potrjenim kot popolni oziroma delni odgovor, v končni analizi
Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g. PD-L2, RNA signature, etc.) predictive of pembrolizumab efficacy should be investigated together with more information regarding the pattern of expression of PD-L1 obtained in the ongoing NSCLC studies (P001, P010, P024 and P042) and urothelial carcinoma studies (KN045, KN052), HNSCC study (KN040) and resected Stage II melanoma adjuvant study (KN716): 
Raziskati je treba dodatne biomarkerje, ki niso PD-L1 po IHC (Immuno Histo Chemistry) statusu izraženosti (npr. PD-L2, RNA genetski podpis itd.), ki napovedujejo učinkovitost pembrolizumaba, skupaj z informacijami v zvezi z vzorcem izražanja PD-L1, ki je bil pridobljen v potekajočih študijah NSCLC (P001, P010, P024 in P042) in študijah urotelijskega raka (KN045, KN052), študiji HNSCC (KN040) in študiji adjuvantnega zdravljenja melanoma v stadiju II, po kirurški odstranitvi (KN716):
Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter. 
Raztopino za infundiranje aplicirajte intravensko v 30 minutah; skozi sterilen, nepirogen, 0,2 do 5 µm linijski ali dodatni filter, ki minimalno veže beljakovine.
KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment. 
Zdravilo KEYTRUDA okrepi odziv T celic, vključno s protitumorskim odzivom, tako, da povzroči blokado vezave PD-1 na PD-L1 in PD-L2, ki sta izražena na antigen prezentirajočih celicah in sta lahko izražena na tumorskih ali drugih celicah v mikrookolju tumorja.
Grade ≥ 3 with creatinine > 3 times ULN 
≥ 3. stopnja s kreatininom > 3-krat nad ZNM
Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment. 
Preiskovanci, pri katerih tumorji izražajo PD-L1 s CPS < 10 in so že vključeni v skupino z monoterapijo s pembrolizumabom, lahko nadaljujejo z zdravljenjem.
Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy. 
Bolniki, pri katerih so se aktivne okužbe pojavile med zdravljenjem s pembrolizumabom, so prejemali ustrezno zdravljenje.
The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4). 
Najresnejši neželeni učinki so bili imunsko pogojeni neželeni učinki in hude z infuzijo povezane reakcije (glejte poglavje 4.4).
NR (1.5+, 38.9+) 
ND (1,5+; 38,9+)
Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well. 
Potem, ko prejmete zdravilo KEYTRUDA, ne upravljajte vozil ali strojev, če niste povsem prepričani, da se dobro počutite.
Based on best response of stable disease or better Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer 
Na podlagi najboljšega odgovora "stabilna bolezen" ali boljšega Na podlagi Kaplan-Meierjevih ocen; vključuje 84 bolnikov, ki so imeli odgovor 6 mesecev ali več
The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL. 
Učinkovitost pembrolizumaba so raziskali v študijah KEYNOTE-087 in KEYNOTE-013, ki sta bili multicentrični, odprti študiji zdravljenja 241 bolnikov s cHL.
Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. 
V primeru imunsko pogojenih endokrinopatij bo morda potrebno dolgotrajno hormonsko nadomestno zdravljenje.
Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). 
Značilnosti bolezni so bile: ploščatocelična (18 %) in neploščatocelična (82 %), M1 (99 %) in metastaze v možganih (9 %).
Table 29 summarises the efficacy measures by IMDC risk category from the pre-specified interim analysis. 
Preglednica 29 povzema ključna merila učinkovitosti po kategoriji tveganja IMDC iz vnaprej določene vmesne analize.
Sixty-five percent of patients had M1c stage, 9% had a history of brain metastases, 66% had no and 34% had one prior therapy. 
Petinšestdeset odstotkov bolnikov je imelo M1c stadij, 9 % jih je imelo v anamnezi metastaze v možganih, 66 % jih predhodno ni prejemalo zdravljenja, 34 % pa jih je predhodno prejemalo eno zdravljenje.
Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013. 
Skupno 20 bolnikov s cHL, starih 65 let ali več, je bilo zdravljenih s pembrolizumabom v študijah KEYNOTE-087 in KEYNOTE-013.
• a kind of cancer called classical Hodgkin lymphoma 
• vrste raka, imenovane klasični Hodgkinov limfom,
Pembrolizumab was administered prior to chemotherapy on Day 1. 
Pembrolizumab je bil 1. dan uporabljen pred kemoterapijo.
Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative. 
Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (79 %), je bilo 69 % (n = 294) PD-L1 pozitivnih in 31 % (n = 134) PD-L1 negativnih.
The prescriber must discuss the risks of KEYTRUDA therapy with the patient. 
Predpisovalec zdravila se mora o tveganjih, povezanih z zdravljenjem z zdravilom KEYTRUDA, pogovoriti z bolnikom.
You may experience more than one side effect at the same time. 
Hkrati se vam lahko pojavi več neželenih učinkov.
In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response. 
V populaciji s Hodgkinovim limfomom je bil ORR 50,0 %, pri 2 bolnikih (11,1 %) je prišlo do popolnega odgovora in pri 7 bolnikih (38,9 %) do delnega odgovora.
In this patient population, the median observation time was 7.3 months (range: 1 day to 31 months) and the most frequent adverse reactions with pembrolizumab were fatigue (32%), nausea (20%), and diarrhoea (20%). 
V tej populaciji bolnikov je mediani čas opazovanja znašal 7,3 mesece (v razponu od 1 dneva do 31 mesecev), najpogostejši neželeni učinki zdravljenja s pembrolizumabom pa so bili utrujenost (32 %), navzea (20 %) in diareja (20 %).
PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells). 
Izraženost PD-L1 so testirali retrospektivno z imunohistokemičnim testom s protitelesom 22C3 proti PD-L1; 84 % bolnikov je imelo PD-L1-pozitivni melanom (izraženost PD-L1 pri ≥ 1 % tumorskih in s tumorjem povezanih imunskih celic v primerjavi z vsemi razpoložljivimi tumorskimi celicami).
Sixtynine (44.8%) patients had 1 or more Grades 3 to 5 adverse reactions of which 6 (3.9%) patients had 1 or more adverse reactions that resulted in death. 
Devetinšestdeset (44,8 %) bolnikov je imelo enega ali več neželenih učinkov od 3. do 5. stopnje, 6 od teh bolnikov (3,9 %) je imelo enega ali več neželenih učinkov, ki so povzročili smrt.
Pembrolizumab has not been studied in patients with severe renal impairment. 
Pembrolizumaba niso raziskali pri bolnikih s hudo okvaro ledvic.
Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. 
Bolnike je treba spremljati glede sprememb delovanja ščitnice (na začetku zdravljenja, periodično med zdravljenjem in kot je indicirano glede na klinično oceno) ter kliničnih znakov in simptomov motenj delovanja ščitnice.
10.3 (6.7, NA) 
10,3 (6,7; NP)
Tables 23 and 24 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS ≥ 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy. 
Preglednici 23 in 24 povzemata ključna merila učinkovitosti za pembrolizumab v študiji KEYNOTE-048 pri bolnikih, ki imajo tumorje z izraženostjo PD-L1 s CPS ≥ 1, ob času končne analize, ki je bila opravljena po medianem času spremljanja 13 mesecev za pembrolizumab v kombinaciji s kemoterapijo in po medianem času spremljanja 11,5 meseca za samostojno zdravljenje s pembrolizumabom.
Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor. 
Med bolniki, ki so imeli tumorje z mutacijo BRAF, jih je bilo 139 (46 %) predhodno zdravljenih z zaviralcem BRAF.
Table 18: Efficacy results in KEYNOTE-087 and KEYNOTE-013 
Preglednica 18: Rezultati učinkovitosti v študijah KEYNOTE-087 in KEYNOTE-013
Seventy-four percent of patients had received Auto-SCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. 
Štiriinsedemdeset odstotkov bolnikov je prejelo avto-SCT, 26 % jih ni bilo primernih za presaditev in 45 % bolnikov je predhodno prejelo radioterapijo.
Secondary efficacy outcome measures were overall response rate (ORR) and response duration. 
Sekundarni merili izida učinkovitosti sta bili celokupni delež odgovora (ORR - overall response rate) in trajanje odgovora.
The Kaplan-Meier curves for OS and PFS are shown in Figures 9 and 10. 
Kaplan-Meierjevi krivulji za OS in PFS sta prikazani na slikah 9 in 10.
Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signaling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3). 
Podatkov o uporabi pembrolizumaba pri nosečnicah ni. S pembrolizumabom niso izvedli študij vpliva na sposobnost razmnoževanja na živalih, vendar pa so v modelih brejosti pri miših ugotovili, da zaviranje signalizacije PD-L1 okvari toleranco na plod in povzroči večjo izgubo plodov (glejte poglavje 5.3).
Blood and lymphatic system disorders Very common anaemia anaemia, neutropaenia, thrombocytopaenia 
Bolezni krvi in limfatičnega sistema Zelo pogosti anemija anemija, nevtropenija, trombocitopenija
The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15. 
Kaplan-Meierjeva krivulja celokupnega preživetja (OS) za TPS ≥ 50 % populacijo je prikazana na sliki 15.
Common pneumonitis pneumonitis pneumonitis 
Pogosti pnevmonitis pnevmonitis pnevmonitis
Table 2: Adverse reactions in patients treated with pembrolizumab* 
Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih s pembrolizumabom*
% with duration ≥ 6 months 
% s trajanjem ≥ 6 mesecev
Use of pembrolizumab for adjuvant treatment of patients with melanoma A trend toward increased frequency of severe and serious adverse reactions in patients ≥ 75 years was observed. 
Uporaba pembrolizumaba pri adjuvantnem zdravljenju bolnikov z melanomom Pri bolnikih, starih ≥ 75 let, so opazili nagnjenost k povečani pogostnosti hudih in resnih neželenih učinkov.
Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease. 
Pri šestnajstih odstotkih (16 %) bolnikov je bolezen napredovala po neoadjuvantnem ali adjuvantnem zdravljenju s kemoterapijo, ki je vključevala platino, 84 % bolnikov pa se je predhodno zdravilo z 1-2 režimoma sistemskega zdravljenja za metastatsko bolezen.
Preliminary data from an early review showed a reduced survival with pembrolizumab monotherapy in patients whose tumours express PD-L1 with a CPS < 10 compared with standard chemotherapy. 
Preliminarni podatki iz zgodnjega pregleda so pokazali zmanjšano preživetje pri monoterapiji s pembrolizumabom pri bolnikih, pri katerih tumorji izražajo PD-L1 s CPS < 10, v primerjavi s standardno kemoterapijo.
Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%). 
Pnevmonitis se je pojavil pogosteje pri bolnikih, ki so se predhodno zdravili z obsevanjem v predelu prsnega koša (8,1 %), kot pri bolnikih, ki se predhodno niso zdravili z obsevanjem v predelu prsnega koša (3,4 %).
Forty-five percent had no prior therapies for advanced melanoma. 
Petinštirideset odstotkov jih predhodno ni bilo zdravljenih zaradi napredovalega melanoma.
What KEYTRUDA looks like and contents of the pack KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 - 5.8. 
Izgled zdravila KEYTRUDA in vsebina pakiranja Zdravilo KEYTRUDA je bistra do nekoliko opalescentna, brezbarvna do rahlo rumenkasta raztopina, pH 5,2-5,8.
Over 15 weeks of follow-up, patients treated with pembrolizumab had stable global health status/QoL, while those treated with investigator's choice chemotherapy had a decline in global health status/QoL. 
Med 15-tedenskim spremljanjem so imeli bolniki, zdravljeni s pembrolizumabom, stabilno celotno zdravstveno stanje/kakovost življenja, medtem ko se je bolnikom, ki so prejemali kemoterapijo po raziskovalčevi izbiri, celotno zdravstveno stanje/kakovost življenja poslabšalo.
BRAF mutant without prior BRAF treatment 
mutacija BRAF brez predhodnega zdravljenja BRAF
Uncommon pancreatitis pancreatitis pancreatitis 
Občasni pankreatitis pankreatitis pankreatitis
(18.3, NA) 
(18,3; NP)
Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. 
Bolnike je treba spremljati glede sprememb delovanja ledvic in izključiti druge vzroke motenega delovanja ledvic.
Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to ≤ 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. 
Bolnikom, ki so prenesli 5 mg aksitiniba dvakrat na dan 2 zaporedna ciklusa zdravljenja (tj. 6 tednov), niso imeli z aksitinibom povezanih neželenih učinkov > 2. stopnje in so imeli krvni tlak dobro urejen do ≤ 150/90 mm Hg, je bilo odmerek aksitiniba dovoljeno povečati na 7 mg dvakrat na dan.
Disease characteristics were: 21% HPV positive and 95% had Stage IV disease (Stage IVa 21%, Stage IVb 6%, and Stage IVc 69%). 
Značilnosti bolezni so bile: 21 % HPVpozitivnih in 95 % bolnikov z boleznijo v IV. stadiju (stadij IVa 21 %, stadij IVb 6 % in stadij IVc
Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology. 
Pembrolizumab je humanizirano monoklonsko protitelo proti receptorjem programirane celične smrti 1 (PD-1) (IgG4 izotip kapa s spremembo zaporedja za stabilizacijo v predelu Fc), pridobljeno s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Results for patients previously treated with ipilimumab (n=84) and naïve to treatment with ipilimumab (n=52) who received 10 mg/kg of pembrolizumab every 3 weeks were similar to those seen in patients who received 2 mg/kg of pembrolizumab every 3 weeks. 
Rezultati pri bolnikih, predhodno zdravljenih z ipilimumabom (n = 84) ali nezdravljenih z ipilimumabom (n = 52), ki so prejemali 10 mg/kg pembrolizumaba na 3 tedne, so bili podobni kot pri bolnikih, ki so prejemali 2 mg/kg pembrolizumaba na 3 tedne.
In patients with NSCLC, pneumonitis occurred in 8.1% with a history of prior thoracic radiation. 
Pri bolnikih z NSCLC se je pnevmonitis pojavil pri 8,1 % tistih, ki so imeli v anamnezi predhodno obsevanje prsnega koša.
The baseline and prognostic disease characteristics of the study population of KEYNOTE-052 included a proportion of patients eligible for a carboplatin-based combination, for whom the benefit is being assessed in a comparative study, and patients eligible for mono-chemotherapy, for whom no randomised data are available. 
Med izhodiščnimi in prognostičnimi značilnostmi bolezni v raziskovani populaciji študije KEYNOTE-052 je bil del bolnikov, primernih za kombinirano zdravljenje na podlagi karboplatina, za katere se korist zdravljenja ocenjuje v primerjalni študiji, ter del bolnikov, primernih za samostojno kemoterapijo, za katere podatki o randomizaciji niso na voljo.
Patient Alert Card 
Opozorilna kartica za bolnike
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa.
Investigations Very common blood creatinine increased alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased 
Preiskave Zelo pogosti zvišan kreatinin v krvi zvišana alaninaminotransferaza, zvišana aspartataminotransferaza, zvišan kreatinin v krvi
Table 28 summarises key efficacy measures from the pre-specified interim analysis. 
Preglednica 28 povzema ključna merila učinkovitosti iz vnaprej določene vmesne analize.
All patients received pembrolizumab for a median of 3 doses (range 1-35 doses), with 130 patients (84.4%) receiving pembrolizumab for 2 doses or more. 
Vsi bolniki so prejeli mediano 3 odmerke pembrolizumaba (v razponu od 1 do 35 odmerkov) in 130 bolnikov (84,4 %) je prejelo 2 odmerka pembrolizumaba ali več.
Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Tumour response was assessed at 12-week intervals. 
Sekundarna merila izida učinkovitosti so bila delež nadzora nad boleznijo (DCR, vključno s popolnim odgovorom, delnim odgovorom in stabilno boleznijo), trajanje odgovora, preživetje brez napredovanja bolezni in celokupno preživetje.
A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. 
Skupno 1.019 odraslih bolnikov so randomizirali (v razmerju 1:1) na prejemanje pembrolizumaba v odmerku 200 mg vsake tri tedne (n = 514) ali placeba (n = 505) do enega leta oziroma do ponovitve bolezni ali pojava nesprejemljivih toksičnih učinkov.
No clinical data are available on the possible effects of pembrolizumab on fertility. 
Kliničnih podatkov o možnih učinkih pembrolizumaba na plodnost ni na voljo.
In KEYNOTE-051, 154 paediatric patients (60 children aged 6 months to less than 12 years and 94 adolescents aged 12 years to 18 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg every 3 weeks. 
V študiji KEYNOTE-051 je 154 pediatričnih bolnikov (60 otrok, v starosti od 6 mesecev do manj kot 12 let, in 94 mladostnikov, v starosti od 12 do 18 let) z napredovalim melanomom ali PD-L1 pozitivnimi, napredovalimi, ponovljenimi ali neodzivnimi čvrstimi tumorji ali limfomi prejemalo 2 mg/kg pembrolizumaba vsake 3 tedne.
If you have any further questions about your treatment, ask your doctor. 
Če imate dodatna vprašanja o svojem zdravljenju, se posvetujte z zdravnikom.
The safety of pembrolizumab was evaluated in a 1-month and a 6-month repeat-dose toxicity study in Cynomolgus monkeys administered intravenous doses of 6, 40 or 200 mg/kg once a week in the 1-month study and once every two weeks in the 6-month study, followed by a 4-month treatment-free period. 
Varnost pembrolizumaba so ocenili v 1-mesečni in 6-mesečni študiji toksičnosti ponavljajočih se odmerkov pri opicah Cynomolgus, ki so prejemale intravenske odmerke 6, 40 ali 200 mg/kg enkrat na teden v 1-mesečni študiji in enkrat na dva tedna v 6-mesečni študiji, čemur je sledilo 4-mesečno obdobje brez zdravljenja.
The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. 
Pogostnosti, navedene v nadaljevanju in v preglednici 2, temeljijo na vseh poročanih neželenih učinkih zdravila, ne glede na raziskovalčevo oceno vzročnosti.
Grade ≥ 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN 
≥ 3. stopnja z AST ali ALT > 5-krat nad ZNM ali celokupni bilirubin > 3-krat nad ZNM
Hypothyroidism may be managed with replacement therapy without treatment interruption. 
Hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem brez prekinitve osnovnega zdravljenja.