natgillin/translations-raw huggingface dataset:
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.
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.