natgillin/translations-raw huggingface dataset:
The events were Grade 3 or less unless stated otherwise:
Učinki so bili 3. stopnje ali manj, če ni navedeno drugače:
These serious side effects include:
Med temi resnimi neželenimi učinki so:
31st October
31. oktober
• Talk to your doctor about the contraception methods that you must use during this time.
• Z zdravnikom se posvetujte o načinu kontracepcije, ki jo morate uporabljati v tem času.
One of the 3 patients was treated with systemic corticosteroids.
Enega od 3 bolnikov so zdravili s sistemskimi kortikosteroidi.
Unopened vial 30 months
Neodprta viala 30 mesecev
Call your doctor as soon as possible to make another appointment.
Čim prej pokličite zdravnika, da se boste dogovorili za drug obisk.
Grades 1-5 (Frequency category)
1.-5. stopnja (Kategorija pogostnosti)
Seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse:
Poiščite nujno zdravniško pomoč, če imate katerega od naslednjih znakov ali simptomov, ali če se vam kateri od njih poslabša:
Inflammation may cause serious damage to your body.
Vnetje lahko v telesu povzroči resno škodo.
No dose reductions are recommended.
Zmanjšanja odmerka niso priporočena.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smete mešati z drugimi zdravili, razen tistih, ki so omenjena v poglavju 6.6.
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a (4) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms.
Zdravnik vam lahko da še druga zdravila za preprečitev še hujših reakcij in za zmanjšanje vaših simptomov.
Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).
Izpostavljenost cemiplimabu je v vseh starostnih skupinah podobna (glejte poglavji 5.1 in 5.2).
Each carton contains 1 vial.
Vsaka škatla vsebuje 1 vialo.
In the absence of data, cemiplimab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Ker podatkov ni, je treba cemiplimab pri teh populacijah uporabljati previdno, po skrbnem ovrednotenju razmerja med koristmi in tveganji za bolnika.
• The patient alert card shall contain the following key messages:
• Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
Results are presented from 193 patients in Study 1540.
Prikazani so rezultati 193 bolnikov v študiji 1540.
Treatment may be continued until disease progression or unacceptable toxicity.
Zdravljenje se sme nadaljevati do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
It is important that you keep this Patient Alert Card and show it to your partner or caregivers.
Pomembno je, da to opozorilno kartico za bolnika shranite in jo pokažete svojemu partnerju/partnerki ali tistim, ki skrbijo za vas.
Thyroid disorders can occur at any time during the treatment.
Ščitnične motnje se lahko pojavijo kadar koli med zdravljenjem.
This is because stopping your treatment may stop the effect of the medicine.
S prenehanjem zdravljenja namreč lahko preneha tudi učinek zdravila.
Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Zdravnik se bo z vami pogovoril o neželenih učinkih in vam bo pojasnil tveganja in koristi zdravljenja.
Efficacy and PD-L1 status
Učinkovitost in stanje PD-L1
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba čitljivo zabeležiti ime in serijsko številko uporabljenega zdravila.
Time to response Median (months) range (min:max)
Čas do odziva Mediana (meseci) razpon (min:maks)
The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Varnost in učinkovitost zdravila LIBTAYO pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
Guillain-Barre syndrome
Guillain-Barréjev sindrom
The physician will provide the Patient Alert Card to each patient.
Zdravnik bo vsakemu bolniku izročil opozorilno kartico za bolnika.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
In particular, tell your doctor if you are taking or have ever taken any of the following medicines:
Še posebej morate zdravniku povedati, če jemljete ali ste kadar koli jemali katero od naslednjih zdravil:
• LIBTAYO can harm your unborn baby.
• Zdravilo LIBTAYO lahko škoduje vašemu nerojenemu otroku.
Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravila LIBTAYO se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
These animal species have similar maternal-foetal interface to that in humans.
Ti dve živalski vrsti imata med materjo in plodom podoben spoj, kot je pri človeku.
Patients excluded from clinical studies
Bolniki, ki niso bili vključeni v klinične študije
• you have an autoimmune disease (a condition where the body attacks its own cells)
• če imate kakšno avtoimunsko bolezen (avtoimunske bolezni so bolezni, pri katerih telo napade svoje lastne celice),
CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
IZ: interval zaupanja, NCP:neodvisen centralni pregled, ND: ni doseženo; +: označuje trajanje ob zadnji ocenitvi.
You may have more than one side effect at the same time.
Pojavi se vam lahko več neželenih učinkov istočasno.
Based on Kaplan Meier estimates d.
Na podlagi Kaplan-Meierjevih ocen.
If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.
Če so viale in/ali intravenske vrečke shranjene v hladilniku, jih je treba pustiti, da pred uporabo dosežejo sobno temperaturo.
The event was Grade 3 hypophysitis.
Šlo je za hipofizitis 3. stopnje.
It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Znano je, da se protitelesa (tudi IgG4) pri človeku izločajo v materino mleko; tveganja za dojene novorojenčke/dojenčke tako ni mogoče izključiti.
• Do not shake the vial.
• Viale ne stresajte.
Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.
Zdravnik bo določil, koliko zdravila LIBTAYO boste potrebovali in kolikokrat.
The recommended dose of LIBTAYO is 350 mg.
Priporočeni odmerek zdravila LIBTAYO je 350 mg.
After opening Once opened, the medicinal product should be diluted and infused immediately.
Po odprtju Ko je zdravilo enkrat odprto, ga je treba nemudoma razredčiti in infundirati.
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Zdravljenje mora uvesti in nadzorovati zdravnik, izkušen na področju zdravljenja raka.
Steady-state exposure is achieved after approximately 4 months of treatment.
Izpostavljenost v stanju dinamičnega ravnovesja je dosežena po približno 4 mesecih zdravljenja.
As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab.
Tako kot pri vseh terapevtskih beljakovinah tudi pri cemiplimabu obstaja možnost imunogenosti.
Patients should be monitored for evidence of suspected severe skin reactions and exclude other causes.
Bolnike je treba spremljati glede znakov sumljivih hudih kožnih reakcij in izključiti druge vzroke.
The information in this Package Leaflet can be found in the Patient Alert Card you have been given by your doctor.
Informacije, ki jih vsebuje to navodilo za uporabo, boste našli tudi na opozorilni izkaznici za bolnika, ki vam jo je dal zdravnik.
The selected adverse reactions described below are based on safety of cemiplimab in 591 patients in uncontrolled clinical studies.
Spodaj opisani izbrani neželeni učinki temeljijo na varnosti cemiplimaba pri 591 bolnikih v nekontroliranih kliničnih študijah.
These immune-related reactions may involve any organ system.
Ti imunsko pogojeni učinki lahko prizadenejo kateri koli organski sistem.
Any unused portion of the infusion solution should not be re-used and should be disposed in accordance with local requirements.
Neporabljenega dela raztopine za infundiranje se ne sme ponovno uporabiti in ga je treba zavreči v skladu z lokalnimi predpisi.
31st March
31. marec
For a full list of patients excluded from clinical trials, see section 5.1.
Za celoten seznam bolnikov, ki niso bili vključeni v klinična preskušanja, glejte poglavje 5.1.
Cemiplimab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Cemiplimab ni priporočljiv med nosečnostjo in za ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen če klinična korist odtehta možno tveganje.
• It is not known if LIBTAYO passes into your breast milk.
• Ni znano, ali zdravilo LIBTAYO prehaja v materino mleko.
As reported in the literature, PD-1 / PD-L1 signalling pathway plays a role in sustaining pregnancy by maintaining immunological tolerance and studies have shown that PD-1 receptor blockade results in early termination of pregnancy.
Kot je opisano v literaturi, igra signalna pot PD-1/PD-L1 vlogo pri ohranjanju nosečnosti z vzdrževanjem imunske tolerance, in študije so pokazale, da blokada receptorja PD-1 povzroči zgodnjo prekinitev nosečnosti.
All patients recovered from the infusion-related reaction.
Vsi bolniki so po reakcijah, povezanih z infundiranjem, okrevali.
These medicines may interfere with the effect of LIBTAYO.
Ta zdravila lahko vplivajo na učinek zdravila LIBTAYO.
The relationship between PD-L1 status and efficacy was analysed post-hoc in patients with available tissue samples.
Povezavo med stanjem PD-L1 in učinkovitostjo so analizirali post hoc pri bolnikih, za katere so bili na voljo vzorci tkiva.
• LIBTAYO is usually given every 3 weeks.
• Zdravilo LIBTAYO se po navadi daje na 3 tedne.
Confirmed objective response rate (ORR)
Potrjeni delež objektivnega odziva (ORR) a
There are no available data on the use of cemiplimab in pregnant women.
Podatkov o uporabi cemiplimaba pri nosečnicah ni.
• Central nervous system problems (such as meningitis)
• težave z osrednjim živčevjem (na primer meningitis),
Patients with DOR ≥ 6 months, % 93.1%
Bolniki z DOR ≥ 6 mesecev, %
Cemiplimab is expected to degrade to small peptides and individual amino acids.
Pričakovati je, da se cemiplimab razgradi v majhne peptide in posamezne aminokisline.
Efficacy results for Study 1540 are presented in Table 3.
Rezultati o učinkovitosti v študiji 1540 so prikazani v preglednici 3.
No neutralizing antibodies have been observed.
Nevtralizacijskih protiteles niso opažali.
• bruises on the skin or bleeding.
• podplutbe ali krvavitve na koži.
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po prvem odprtju ali razredčenju zdravila glejte poglavje 6.3.
The primary endpoint of Study 1540 was confirmed objective response rate (ORR), as assessed by independent central review (ICR).
Primarni opazovani dogodek študije 1540 je bil potrjeni delež objektivnega odziva (ORR - objective response rate ), ocenjen z neodvisnim centralnim pregledom (NCP).
Some inflammatory conditions may also lead to death and need treatment, or you may need to stop treatment with LIBTAYO.
Nekatere vnetne bolezni lahko celo povzročijo smrt in zahtevajo zdravljenje, ali pa bo morda treba vaše zdravljenje z zdravilom LIBTAYO končati.
Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2
3. ali 4. stopnja (izključujoč endokrinopatije) ali ponovna 2. stopnja
Overall survival a, c, d
Celokupno preživetjea, c, d. 12 mesecev
Among patients with mCSCC, 76.5% had distant metastases, and 22.6% had only nodal metastases.
Med bolniki z mPCKK jih je 76,5 % imelo oddaljene metastaze in 22,6 % le metastaze v bezgavkah.
If patients with locally advanced disease showed sufficient response to treatment, surgery with curative intent was permitted.
Pri bolnikih z lokalno napredovalo boleznijo, ki so dosegli zadosten odziv na zdravljenje, je bila dovoljena operacija s kurativnim namenom.
Patients should be monitored for signs and symptoms of pneumonitis.
Bolnike je treba spremljati glede znakov in simptomov pnevmonitisa.
Patients that had active infections or that were immunocompromised were not included in the main study.
Bolniki z aktivnimi okužbami in imunsko oslabeli bolniki niso bili vključeni v glavno študijo.
However, once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce the side effects that you may have with LIBTAYO.
A ko boste že prejemali zdravljenje z zdravilom LIBTAYO, vam bo zdravnik morda dal kortikosteroide za zmanjšanje neželenih učinkov, ki se vam lahko pojavijo z zdravilom LIBTAYO.
Dispose of any unused medicinal product or waste material in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The final concentration of the diluted solution should be between 1 mg/ml to 20 mg/ml.
Končna koncentracija razredčene raztopine mora biti med 1 mg/ml in 20 mg/ml.
Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing foetus resulting in foetal death (see section 5.3).
Študije na živalih so pokazale, da zavrtje poti PD1/PD-L1 lahko poveča tveganje za imunsko posredovano zavrnitev razvijajočega se ploda s posledično smrtjo ploda (glejte poglavje 5.3).
Grade 4 or confirmed SJS or TEN
4. stopnja ali potrjen SJS ali TEN
In Study 1540, patients received cemiplimab until progression of disease, unacceptable toxicity or completion of planned treatment [3 mg/kg every 2 weeks for 96 weeks or 350 mg every 3 weeks for 54 weeks].
V študiji 1540 so bolniki prejemali cemiplimab do napredovanja bolezni, nesprejemljivih toksičnih učinkov ali dokončanja načrtovanega zdravljenja [3 mg/kg na 2 tedna 96 tednov ali 350 mg na 3 tedne 54 tednov].
• It is important that you keep the Patient Alert Card with you during treatment.
• Pomembno je, da imate med zdravljenjem vedno pri sebi opozorilno kartico za bolnika.
o The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first.
o Opozorilo o tem, kako pomembno je, da bolnik ne poskuša sam zdraviti nobenih simptomov, ne da bi se prej posvetoval z zdravnikom.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of cemiplimab (see “Description of selected adverse reactions” below).
Večina teh, vključno s hudimi učinki, je izzvenela po uvedbi ustreznega zdravljenja ali prenehanju uporabe cemiplimaba (glejte "Opis izbranih neželenih učinkov", spodaj).
No clinical data are available on the possible effects of cemiplimab on fertility.
Kliničnih podatkov o možnih učinkih cemiplimaba na plodnost ni.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Med temi preiskovanci in mlajšimi preiskovanci na splošno niso opažali razlik v varnosti ali učinkovitosti.
Cemiplimab clearance after the first dose is approximately 0.33 l/day.
Po prvem odmerku je očistek cemiplimaba približno 0,33 l/dan.
If diluted solution is not administered immediately, it may be stored temporarily either:
Če razredčene raztopine ne uporabite nemudoma, je lahko prehodno shranjena ali:
Overall in Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients.
Skupno so bili v študijah 1423 in 1540 na voljo rezultati IHC PD-L1 za 75 bolnikov z napredovalim PCKK.
• Liver problems (hepatitis)
• težave z jetri (hepatitis),
• inflammation of the covering of the heart
• vnetje mrene, ki prekriva srce
• increased liver enzymes in blood, abnormal kidney function test
• zvišanje jetrnih encimov v krvi, nenormalen izvid preiskave delovanja ledvic
Of these 193 patients, 115 had mCSCC and 78 had laCSCC.
Od teh 193 bolnikov jih je 115 imelo mPCKK in 78 lnPCKK.
Cemiplimab has no or negligible influence on the ability to drive and use machines.
Cemiplimab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Clinical activity was observed regardless of tumour PD-L1 expression status.
Klinično delovanje so opažali ne glede na stanje izraženosti PD-L1 na tumorju.
From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 8°C).
Od tedaj, ko je zdravilo LIBTAYO pripravljeno z razredčenjem v intravenski vrečki, ga je mogoče pred uporabo shranjevati največ 8 ur pri temperaturi do 25 °C in ne več kot 24 ur v hladilniku (od 2 do 8 °C).
o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities.
o Opomnik, da lahko bolnik o vseh znanih ali domnevnih neželenih učinkih zdravila poroča tudi lokalnim regulatornim organom.
The total clearance appears to decrease by approximately 35% over time, resulting in a steady state clearance (CLss) of 0.21 l/day; the decrease in CL is not considered clinically relevant.
Po vsem sodeč se celotni očistek sčasoma zmanjša za približno 35 %, tako da je očistek v stanju dinamičnega ravnovesja (CLss) 0,21 l/dan; zmanjšanje očistka ne velja za klinično pomembno.
Your doctor will test your blood for certain side effects during your treatment.
Zdravnik bo med zdravljenjem zaradi določenih neželenih učinkov opravil preiskave krvi.
Do not stop treatment of LIBTAYO unless you have discussed this with your doctor.
Ne prenehajte zdravljenja z zdravilom LIBTAYO, ne da bi se o tem posvetovali z zdravnikom.
• If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant: while you are being treated with LIBTAYO and for at least 4 months after the last dose.
• Če lahko zanosite, morate uporabljati učinkovit način kontracepcije za preprečitev nosečnosti: medtem ko prejemate zdravljenje z zdravilom LIBTAYO in vsaj še 4 mesece po zadnjem odmerku.
Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients.
Datum zamejitve podatkov je bil 20. september 2018 za skupini 1 in 3 ter 10. oktober 2018 za skupino 2.
Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response.
b. Vključuje le bolnike s popolno ozdravitvijo predhodne prizadetosti kože; pri bolnikih z lokalno napredovalim PCKK v študiji 1540 je bila za potrditev popolnega odziva zahtevana biopsija.
The following side effects have been reported in clinical trials of patients with CSCC: Very common (may affect more than 1 in 10 people):
V kliničnih preskušanjih pri bolnikih s PCKK so poročali o naslednjih neželenih učinkih: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
What LIBTAYO is and what it is used for 2.
Kaj je zdravilo LIBTAYO in za kaj ga uporabljamo 2.
Patient Alert Card
Opozorilna kartica za bolnika
Concentrate for solution for infusion (sterile concentrate).
Koncentrat za raztopino za infundiranje (sterilen koncentrat).
The effect of hepatic impairment on the exposure of cemiplimab was evaluated by population PK analysis.
Vpliv okvare jeter na izpostavljenost cemiplimabu so ovrednotili s populacijsko farmakokinetično analizo.
Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab.
Podatki o koncentracijah so bili zbrani pri 548 bolnikih z različnimi čvrstimi tumorji, vključno s 178 bolniki s PCKK, ki so prejemali cemiplimab.
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Trajno prenehajte uporabljati ALT: alanin-aminotransferaza, AST: aspartat-aminotransferaza, ZMN: zgornja meja normalnih vrednosti.
What you need to know before you use LIBTAYO 3.
Kaj morate vedeti, preden boste uporabili zdravilo LIBTAYO 3.
o 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).
o Opomnik, naj ima bolnik opozorilno kartico za bolnika vedno pri sebi in naj jo pokaže na vseh obiskih pri drugih zdravstvenih delavcih razen pri zdravniku, ki je zdravilo predpisal (npr. zdravstveni delavci nujne medicinske pomoči).
Adverse reactions were serious in 8.6% patients and led to permanent discontinuation of cemiplimab in 5.8% of patients.
Neželeni učinki so bili resni pri 8,6 % bolnikov in so povzročili trajno prenehanje uporabe cemiplimaba pri 5,8 % bolnikov.
Absorption Cemiplimab is administered via the intravenous route and hence is completely bioavailable.
Absorpcija Cemiplimab se uporablja intravensko, zato je biološka uporabnost popolna.
Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and
Cemiplimab je popolnoma človeško imunoglobulinsko monoklonsko protitelo G4 (IgG4), ki se veže na receptor programirane celične smrti 1 (PD-1) in blokira njegovo interakcijo z ligandoma PD-L1 in PD-L2.
L-histidine monohydrochloride monohydrate Sucrose
L-histidinijev monoklorid monohidrat saharoza
A population PK analysis suggests that the following factors have no clinically significant effect on the exposure of cemiplimab: age, gender, body weight, race, cancer type, albumin level, mild hepatic impairment and renal impairment.
Populacijska farmakokinetična analiza kaže, da naslednji dejavniki ne vplivajo klinično pomembno na izpostavljenost cemiplimabu: starost, spol, telesna masa, rasa, vrsta raka, koncentracija albumina, blaga okvara jeter in okvara ledvic.
• you have had an organ transplant
• če imate presajen organ,
The MAH shall ensure that in each Member State where LIBTAYO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use LIBTAYO have access to/are provided with the following educational package: - A patient guide - A patient alert card
Imetnik dovoljenja za promet z zdravilom mora v vseh državah članicah, kjer bo zdravilo LIBTAYO na trgu, zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predvidoma predpisovali zdravilo LIBTAYO, in vsi bolniki/skrbniki, ki ga bodo predvidoma uporabljali, imeli dostop ali prejeli naslednji paket izobraževalnih gradiv: - Vodnik za bolnika - Opozorilna kartica za bolnika
The MAH should investigate biomarkers in order to confirm that PD-L1 expression is not predictive of efficacy.
Imetnik dovoljenja za promet z zdravilom mora raziskati biološke označevalce za potrditev, da izraženost PD-L1 ni napovednik učinkovitosti.
Prior to launch of LIBTAYO 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 LIBTAYO na trg v 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 morebitnimi drugimi vidiki programa.