natgillin/translations-raw huggingface dataset:
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Propylene glycol 
6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat propilenglikol dinatrijev edetat voda za injekcije
• Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle. 
• Zdravilo Rapiscan se daje v obliki hitrega, 10-sekundnega injiciranja v periferno veno s katetrom ali iglo velikosti 22 ali z večjim katetrom ali iglo.
Radionuclide myocardial perfusion imaging (MPI) 
Radionuklidno slikanje miokardne perfuzije
Renal impairment No dose adjustment is necessary (see section 5.2). 
Okvara ledvic Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Very common Gastrointestinal discomfort Common 
Zelo pogosti prebavno nelagodje
You should avoid breast-feeding for at least 10 hours after you are given Rapiscan. 
Vsaj 10 ur po tem, ko prejmete zdravilo Rapiscan, ne smete dojiti.
Despite low affinity for the A2A adenosine receptor, regadenoson has high potency for increasing coronary conductance in rat and guinea pig isolated hearts, with EC50 values of 6.4 nM and 6.7-18.6 nM, respectively. 
Kljub nizki afiniteti za receptor adenozina A2A, ima regadenozon veliko moč zvišati koronarno prevodnost na izoliranih srcih podgan in morskih prašičkov, pri čemer so bile vrednosti EC50 6,4 nM oz 6,7-18,6 nM. Regadenozon kaže selektivnost (≥ 215kratno) za zvišanje koronarne prevodnosti (odziv, ki ga posreduje A2A) glede na upočasnitev srčnega prevajanja AV vozla (odziv, ki ga posreduje A1), merjeno s časom AV prevajanja (srce podgane) ali intervalom S-H (srce budre).
Myocardial uptake of the radiopharmaceutical is proportional to CBF. 
Miokardni privzem radiofarmacevtskega izdelka je sorazmeren s koronarnim krvnim pretokom.
Appropriate bronchodilator therapy and resuscitative measures should be available prior to regadenoson administration. 
Pred dajanjem regadenozona je treba zagotoviti, da so na voljo ustrezno zdravljenje z bronhodilatatorji in ukrepi za oživljanje srca.
• fits, fainting, mini strokes (including weakness of the face or an inability to speak), reduced responsiveness (which may include a comatose state), trembling, sleepiness 
• krči, omedlevica, majhne kapi (vključno z oslabelostjo obraza ali nezmožnostjo govoriti),
Nervous system disorders: 
Bolezni imunskega sistema:
Usually, exercise on a treadmill is used to put the heart under stress before a scan. 
Za obremenitev srca pred slikanjem se običajno uporablja vadba na tekalni stezi.
Aminophylline has been used to attenuate adverse reactions to regadenoson (see section 4.4). 
Aminofilin se uporablja za zmanjšanje neželenih učinkov na regadenozon (glejte poglavje
No dose adjustment is needed in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter ni treba prilagajati odmerka.
Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle. 
Zdravilo Rapiscan se daje v obliki hitrega, 10-sekundnega injiciranja v periferno veno s katetrom ali iglo velikosti 22 ali z večjim katetrom ali iglo.
What Rapiscan contains 
Kaj vsebuje zdravilo Rapiscan
The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10-20 seconds after the sodium chloride 9 mg/ml (0.9%) solution for injection. 
Radiofarmacevtski izdelek za zdravilo, ki se uporablja za slikanje miokardne perfuzije je treba dati 1020 sekund po 0,9% (9 mg/ml) raztopini natrijevega klorida za injiciranje.
Hepatic impairment No dose adjustment is necessary (see section 5.2). 
Okvara jeter Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Keep this leaflet. 
• Navodilo shranite.
Solution for injection Clear, colourless solution. 
raztopina za injiciranje bistra, brezbarvna raztopina
The active substance in Rapiscan is regadenoson. 
Učinkovina v zdravilu Rapiscan je regadenozon.
Regadenoson should be used with caution in patients with recent myocardial infarction. 
Pri dajanju regadenozona bolnikom po nedavnem miokardnem infarktu je potrebna previdnost.
Haemodynamic effects 
Hemodinamični učinki
Rapiscan 400 microgram solution for injection regadenoson 
Rapiscan 400 mikrogramov raztopina za injiciranje regadenozon intravenska uporaba
Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson. 
Ishemija zaradi zdravila za farmakološko obremenitev, kot je regadenozon, lahko povzroči srčni zastoj s smrtnim izidom, življenje ogrožajoče ventrikularne aritmije in miokardni infarkt.
Very common Flushing Common 
Zelo pogosti vročinski oblivi
No dose adjustment is needed in patients with renal impairment. 
Pri bolnikih z okvaro ledvic ni treba prilagajati odmerka.
Hypersensitivity reactions including: Rash, urticaria, angioedema, anaphylaxis Psychiatric disorders: 
Občasni preobčutljivostne reakcije, vključno z naslednjimi: izpuščaj, koprivnica, angioedem,
Pain at injection site, general body pain 
Pogosti slabost, astenija Občasni bolečina na mestu injiciranja, splošne telesne bolečine
• bloating, diarrhoea, involuntary loss of faeces 
• napenjanje, driska, nehotno odvajanje blata
ANNEX 1 
PRILOGA I
Fatal cardiac arrest, life-threatening ventricular arrhythmias and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents. 
Ishemija zaradi zdravila za farmakološko obremenitev lahko povzroči srčni zastoj s smrtnim izidom, življenje ogrožajoče ventrikularne aritmije in miokardni infarkt.
FFR was measured after IV infusion of adenosine and IV injection of regadenoson (400 μg). 
injekciji regadenozona (400 µg).
• chest pain 
• kratka sapa
• shortness of breath 
• piskanje v pljučih
• 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan. 
• Takoj po injiciranju zdravila Rapiscan je treba dati 5 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
• 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan. 
• Takoj po injiciranju zdravila Rapiscan je treba dati 10 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
10 mL of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan. 
Takoj po injiciranju zdravila Rapiscan je treba dati 10 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
Vascular disorders: 
Žilne bolezni:
5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan. 
Takoj po injiciranju zdravila Rapiscan je treba dati 5 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
Hepatic impairment 
Pogosti hipotenzija
• blurred vision, eye pain 
• zamegljen vid, bolečina v očeh
Very common Headache, dizziness Common 
Bolezni živčevja: Zelo pogosti glavobol, omotica
Vision blurred, eye pain Ear and labyrinth disorders: Uncommon 
Občasni zamegljen vid, bolečina v očeh Ušesne bolezni, vključno z motnjami labirinta: Občasni tinitus
Disodium edetate 
Okvara jeter
Following intravenous administration of 
Po intravenskem dajanju z
Adenosine - regadenoson Agreement Rate (± SE) 62 ± 2% 63 ± 3% 63 ± 2% Number of Patients (n) 
Adenozin - regadenozon stopnja ujemanja (± SE) Število bolnikov (n)
MA (EU) number 
Številka postopka EMA
The study should be conducted according to an agreed protocol. 
Študija mora biti izvedena v skladu z dogovorjenim protokolom.
• Problems in other parts of the body. 
• težave v drugih delih telesa.
This leaflet was last revised in June 2019. 
Navodilo je bilo nazadnje revidirano junija 2019.
Overall survival does not require central review. 
Celokupno preživetje ne zahteva centralnega pregleda.
If you feel tired, do not drive or use machines until you feel better. 
Če se počutite utrujene, ne upravljajte vozil in strojev, dokler se ne počutite bolje.
• The infusion will last about 30 minutes. 
• Infundiranje bo trajalo približno 30 minut.
ATC code: not yet assigned 
Oznaka ATC: še ni bila dodeljena
• feeling tired 
• občutek utrujenosti
It is very important that you do not miss a dose of this medicine. 
Zelo pomembno je, da ne izpustite odmerka tega zdravila.
How much you will receive 
Koliko zdravila boste prejeli
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.