FrancophonIA/ELRC3.0 huggingface dataset:
English: Radionuclide myocardial perfusion imaging (MPI):
Slovenian: Radionuklidno slikanje miokardne perfuzije:
English: When possible, dipyridamole should be withheld for at least two days prior to regadenoson administration (see section 4.2).
Slovenian: Bolnik ne sme jemati dipiridamola vsaj dva dni pred dajanjem regadenozona (glejte poglavje 4.2).
English: Dipyridamole
Slovenian: Dipiridamol
English: The most common cardiovascular conditions were patients with a medical history of hypertension, dyslipidemia / hypercholesterolemia, diabetes mellitus, smoking, prior PCI and prior MI.
Slovenian: Najpogostejša obolenja srca in ožilja v anamnezi pri bolnikih so vključevala hipertenzijo, dislipidemijo / hiperholesterolemijo, sladkorno bolezen, kajenje, predhodno perkutano koronarno intervencijo (PCI) in predhodni miokardni infarkt.
English: Rapiscan 400 microgram solution for injection
Slovenian: Rapiscan 400 mikrogramov raztopina za injiciranje
English: Sensitivity Specificity
Slovenian: Specifičnost
English: Throat tightness, throat irritation, cough
Slovenian: • stiskanje v grlu, draženje grla, kašelj
English: Signs of hypersensitivity (rash, urticaria, angioedema, anaphylaxis and/or throat tightness) may be immediate or delayed onset.
Slovenian: Takoj ali z zamikom se lahko pojavijo znaki preobčutljivosti (izpuščaj, koprivnica, angioedem, anafilaksa in/ali stiskanje v grlu).
English: Angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged
Slovenian: Pogosti angina pektoris, atrioventrikularni blok, tahikardija, palpitacije, druge nenormalnosti EKG
English: Fractional Flow Reserve (FFR)
Slovenian: Meritev funkcionalne pretočne rezerve (FFR)
English: Musculoskeletal and connective tissue disorders: Common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva:
English: • rapid breathing
Slovenian: • hitro dihanje
English: Anxiety, insomnia
Slovenian: Občasni anksioznost, nespečnost
English: Elderly No dose adjustment is necessary (see section 5.2).
Slovenian: Starejši bolniki Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Excipients: Disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, disodium edetate, water for injections
Slovenian: Pomožne snovi: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat monohidrat, propilenglikol, dinatrijev edetat, voda za injekcije
English: • headache, dizziness
Slovenian: • glavobol, omotica
English: Rapiscan contains sodium
Slovenian: Zdravilo Rapiscan vsebuje natrij
English: Radionuclide MPI clinical trials conducted with regadenoson excluded patients with recent (within 3 months) myocardial infarction.
Slovenian: Radionuklidno slikanje miokardne perfuzije - bolniki z nedavnim (v zadnjih 3 mesecih) miokardnim infarktom niso bili vključeni v klinična preskušanja, opravljena z regadenozonom.
English: For the measurement of FFR, Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
Slovenian: Za merjenje funkcionalne pretočne rezerve (FFR) se zdravilo Rapiscan daje v obliki hitrega, 10sekundnega injiciranja v periferno veno s katetrom ali iglo velikosti 22 ali z večjim katetrom ali iglo.
English: In clinical trials first degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of regadenoson administration; transient second degree AV block with one dropped beat was observed in one patient receiving regadenoson.
Slovenian: V kliničnih študijah se je v roku 2 ur po dajanju regadenozona pri 3% bolnikov pojavil AV blok prve stopnje (podaljšanje intervala PR > 220
English: Use product only in medical facilities with cardiac monitoring and resuscitation equipment.
Slovenian: Zdravilo uporabljajte samo v zdravstvenih ustanovah, kjer obstaja možnost nadziranja srčne funkcije in je na voljo oprema za oživljanje srca.
English: Rapiscan may make you feel dizzy.
Slovenian: Zaradi zdravila Rapiscan ste lahko omotični.
English: Standard catheterisation and FFR measurement techniques are to be followed, and FFR should be measured as the lowest value of Pd/Pa achieved during steady state maximum hyperemia.
Slovenian: FFR je treba meriti kot najnižjo vrednost Pd/Pa, doseženo med hiperemijo v stanju ravnotežja.
English: Risk of seizure
Slovenian: Tveganje za epileptični napad
English: Regadenoson administration may result in adverse reactions such as dizziness, headache, and dyspnoea (see section 4.8) soon after administration.
Slovenian: Dajanje regadenozona lahko kmalu po aplikaciji povzroči neželene učinke kot so omotica, glavobol in dispneja (glejte poglavje 4.8).
English: Common side effects (affects 1 to 10 users in 100)
Slovenian: Pogosti neželeni učinki (pojavijo se pri do 1 do 10 od 100 bolnikov)
English: Back, neck or jaw pain, pain in extremity, musculoskeletal discomfort
Slovenian: Pogosti bolečina hrbta, vratu ali čeljusti, bolečina okončin, mišično-skeletno nelagodje Občasni artralgija
English: How to store Rapiscan
Slovenian: Kako se daje zdravilo Rapiscan
English: This is because caffeine can interfere with the effect of Rapiscan.
Slovenian: Vsa našteta živila vsebujejo kofein, ki lahko medsebojno učinkuje z učinki zdravila Rapiscan.
English: • 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.
Slovenian: • Radiofarmacevtski izdelek za zdravilo, ki se uporablja za slikanje miokardne perfuzije je treba dati 10-20 sekund po 0,9% (9 mg/ml) raztopini natrijevega klorida za injiciranje.
English: No serious cardiac adverse reactions occurred in patients receiving regadenoson 1 hour following inadequate exercise stress.
Slovenian: Pri bolnikih, ki so prejeli regadenozon 1 uro po nezadostni obrementitvi z vadbo, ni prišlo do resnih neželenih učinkov na srce.
English: Abdominal distension, diarrhoea, faecal incontinence Skin and subcutaneous tissue disorders: Common
Slovenian: Občasni trebušna distenzija, driska, fekalna inkontinenca Bolezni kože in podkožja:
English: When possible, dipyridamole should be withheld for at least two days prior to Rapiscan administration (see section 4.5).
Slovenian: Bolnik ne sme jemati dipiridamola vsaj dva dni pred dajanjem zdravila Rapiscan (glejte poglavje 4.5).
English: Regadenoson is administered by intravenous injection for pharmacologic stress radionuclide MPI.
Slovenian: Regadenozon se za farmakološko obremenitev radionuklidnega slikanja miokardne perfuzije daje v obliki intravenskega injiciranja.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Propylene glycol
Slovenian: 6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat propilenglikol dinatrijev edetat voda za injekcije
English: • Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
Slovenian: • 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.
English: Radionuclide myocardial perfusion imaging (MPI)
Slovenian: Radionuklidno slikanje miokardne perfuzije
English: Renal impairment No dose adjustment is necessary (see section 5.2).
Slovenian: Okvara ledvic Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Very common Gastrointestinal discomfort Common
Slovenian: Zelo pogosti prebavno nelagodje
English: You should avoid breast-feeding for at least 10 hours after you are given Rapiscan.
Slovenian: Vsaj 10 ur po tem, ko prejmete zdravilo Rapiscan, ne smete dojiti.
English: 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.
Slovenian: 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).
English: Myocardial uptake of the radiopharmaceutical is proportional to CBF.
Slovenian: Miokardni privzem radiofarmacevtskega izdelka je sorazmeren s koronarnim krvnim pretokom.
English: Appropriate bronchodilator therapy and resuscitative measures should be available prior to regadenoson administration.
Slovenian: Pred dajanjem regadenozona je treba zagotoviti, da so na voljo ustrezno zdravljenje z bronhodilatatorji in ukrepi za oživljanje srca.
English: • fits, fainting, mini strokes (including weakness of the face or an inability to speak), reduced responsiveness (which may include a comatose state), trembling, sleepiness
Slovenian: • krči, omedlevica, majhne kapi (vključno z oslabelostjo obraza ali nezmožnostjo govoriti),
English: Nervous system disorders:
Slovenian: Bolezni imunskega sistema:
English: Usually, exercise on a treadmill is used to put the heart under stress before a scan.
Slovenian: Za obremenitev srca pred slikanjem se običajno uporablja vadba na tekalni stezi.
English: Aminophylline has been used to attenuate adverse reactions to regadenoson (see section 4.4).
Slovenian: Aminofilin se uporablja za zmanjšanje neželenih učinkov na regadenozon (glejte poglavje
English: No dose adjustment is needed in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni treba prilagajati odmerka.
English: Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
Slovenian: 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.
English: What Rapiscan contains
Slovenian: Kaj vsebuje zdravilo Rapiscan
English: 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.
Slovenian: 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.
English: Hepatic impairment No dose adjustment is necessary (see section 5.2).
Slovenian: Okvara jeter Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Keep this leaflet.
Slovenian: • Navodilo shranite.
English: Solution for injection Clear, colourless solution.
Slovenian: raztopina za injiciranje bistra, brezbarvna raztopina
English: The active substance in Rapiscan is regadenoson.
Slovenian: Učinkovina v zdravilu Rapiscan je regadenozon.
English: Regadenoson should be used with caution in patients with recent myocardial infarction.
Slovenian: Pri dajanju regadenozona bolnikom po nedavnem miokardnem infarktu je potrebna previdnost.
English: Haemodynamic effects
Slovenian: Hemodinamični učinki
English: Rapiscan 400 microgram solution for injection regadenoson
Slovenian: Rapiscan 400 mikrogramov raztopina za injiciranje regadenozon intravenska uporaba
English: Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson.
Slovenian: Ishemija zaradi zdravila za farmakološko obremenitev, kot je regadenozon, lahko povzroči srčni zastoj s smrtnim izidom, življenje ogrožajoče ventrikularne aritmije in miokardni infarkt.
English: Very common Flushing Common
Slovenian: Zelo pogosti vročinski oblivi
English: No dose adjustment is needed in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic ni treba prilagajati odmerka.
English: Hypersensitivity reactions including: Rash, urticaria, angioedema, anaphylaxis Psychiatric disorders:
Slovenian: Občasni preobčutljivostne reakcije, vključno z naslednjimi: izpuščaj, koprivnica, angioedem,
English: Pain at injection site, general body pain
Slovenian: Pogosti slabost, astenija Občasni bolečina na mestu injiciranja, splošne telesne bolečine
English: • bloating, diarrhoea, involuntary loss of faeces
Slovenian: • napenjanje, driska, nehotno odvajanje blata
English: ANNEX 1
Slovenian: PRILOGA I
English: Fatal cardiac arrest, life-threatening ventricular arrhythmias and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents.
Slovenian: Ishemija zaradi zdravila za farmakološko obremenitev lahko povzroči srčni zastoj s smrtnim izidom, življenje ogrožajoče ventrikularne aritmije in miokardni infarkt.
English: FFR was measured after IV infusion of adenosine and IV injection of regadenoson (400 μg).
Slovenian: injekciji regadenozona (400 µg).
English: • chest pain
Slovenian: • kratka sapa
English: • shortness of breath
Slovenian: • piskanje v pljučih
English: Arthralgia
Slovenian: Norveška
English: • 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Slovenian: • Takoj po injiciranju zdravila Rapiscan je treba dati 5 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
English: • 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Slovenian: • Takoj po injiciranju zdravila Rapiscan je treba dati 10 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
English: 10 mL of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Slovenian: Takoj po injiciranju zdravila Rapiscan je treba dati 10 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
English: Vascular disorders:
Slovenian: Žilne bolezni:
English: 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Slovenian: Takoj po injiciranju zdravila Rapiscan je treba dati 5 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje.
English: Hepatic impairment
Slovenian: Pogosti hipotenzija
English: • blurred vision, eye pain
Slovenian: • zamegljen vid, bolečina v očeh
English: Very common Headache, dizziness Common
Slovenian: Bolezni živčevja: Zelo pogosti glavobol, omotica
English: Vision blurred, eye pain Ear and labyrinth disorders: Uncommon
Slovenian: Občasni zamegljen vid, bolečina v očeh Ušesne bolezni, vključno z motnjami labirinta: Občasni tinitus
English: Disodium edetate
Slovenian: Okvara jeter
English: Following intravenous administration of
Slovenian: Po intravenskem dajanju z
English: Adenosine - regadenoson Agreement Rate (± SE) 62 ± 2% 63 ± 3% 63 ± 2% Number of Patients (n)
Slovenian: Adenozin - regadenozon stopnja ujemanja (± SE) Število bolnikov (n)
English: MA (EU) number
Slovenian: Številka postopka EMA
English: The study should be conducted according to an agreed protocol.
Slovenian: Študija mora biti izvedena v skladu z dogovorjenim protokolom.
English: • Problems in other parts of the body.
Slovenian: • težave v drugih delih telesa.
English: This leaflet was last revised in June 2019.
Slovenian: Navodilo je bilo nazadnje revidirano junija 2019.
English: Overall survival does not require central review.
Slovenian: Celokupno preživetje ne zahteva centralnega pregleda.
English: If you feel tired, do not drive or use machines until you feel better.
Slovenian: Če se počutite utrujene, ne upravljajte vozil in strojev, dokler se ne počutite bolje.
English: • The infusion will last about 30 minutes.
Slovenian: • Infundiranje bo trajalo približno 30 minut.
English: ATC code: not yet assigned
Slovenian: Oznaka ATC: še ni bila dodeljena
English: • feeling tired
Slovenian: • občutek utrujenosti
English: It is very important that you do not miss a dose of this medicine.
Slovenian: Zelo pomembno je, da ne izpustite odmerka tega zdravila.
English: How much you will receive
Slovenian: Koliko zdravila boste prejeli
English: The events were Grade 3 or less unless stated otherwise:
Slovenian: Učinki so bili 3. stopnje ali manj, če ni navedeno drugače:
English: These serious side effects include:
Slovenian: Med temi resnimi neželenimi učinki so:
English: 31st October
Slovenian: 31. oktober
English: • Talk to your doctor about the contraception methods that you must use during this time.
Slovenian: • Z zdravnikom se posvetujte o načinu kontracepcije, ki jo morate uporabljati v tem času.
English: One of the 3 patients was treated with systemic corticosteroids.
Slovenian: Enega od 3 bolnikov so zdravili s sistemskimi kortikosteroidi.
English: Unopened vial 30 months
Slovenian: Neodprta viala 30 mesecev
English: Call your doctor as soon as possible to make another appointment.
Slovenian: Čim prej pokličite zdravnika, da se boste dogovorili za drug obisk.
English: Grades 1-5 (Frequency category)
Slovenian: 1.-5. stopnja (Kategorija pogostnosti)
English: Seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse:
Slovenian: Poiščite nujno zdravniško pomoč, če imate katerega od naslednjih znakov ali simptomov, ali če se vam kateri od njih poslabša:
English: Inflammation may cause serious damage to your body.
Slovenian: Vnetje lahko v telesu povzroči resno škodo.
English: No dose reductions are recommended.
Slovenian: Zmanjšanja odmerka niso priporočena.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smete mešati z drugimi zdravili, razen tistih, ki so omenjena v poglavju 6.6.
English: 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:
Slovenian: 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:
English: Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms.
Slovenian: Zdravnik vam lahko da še druga zdravila za preprečitev še hujših reakcij in za zmanjšanje vaših simptomov.
English: Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).
Slovenian: Izpostavljenost cemiplimabu je v vseh starostnih skupinah podobna (glejte poglavji 5.1 in 5.2).
English: Each carton contains 1 vial.
Slovenian: Vsaka škatla vsebuje 1 vialo.
English: 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.
Slovenian: Ker podatkov ni, je treba cemiplimab pri teh populacijah uporabljati previdno, po skrbnem ovrednotenju razmerja med koristmi in tveganji za bolnika.
English: • The patient alert card shall contain the following key messages:
Slovenian: • Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
English: Results are presented from 193 patients in Study 1540.
Slovenian: Prikazani so rezultati 193 bolnikov v študiji 1540.
English: Treatment may be continued until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje se sme nadaljevati do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: It is important that you keep this Patient Alert Card and show it to your partner or caregivers.
Slovenian: Pomembno je, da to opozorilno kartico za bolnika shranite in jo pokažete svojemu partnerju/partnerki ali tistim, ki skrbijo za vas.
English: Thyroid disorders can occur at any time during the treatment.
Slovenian: Ščitnične motnje se lahko pojavijo kadar koli med zdravljenjem.
English: This is because stopping your treatment may stop the effect of the medicine.
Slovenian: S prenehanjem zdravljenja namreč lahko preneha tudi učinek zdravila.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Slovenian: Zdravnik se bo z vami pogovoril o neželenih učinkih in vam bo pojasnil tveganja in koristi zdravljenja.
English: Efficacy and PD-L1 status
Slovenian: Učinkovitost in stanje PD-L1
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba čitljivo zabeležiti ime in serijsko številko uporabljenega zdravila.
English: Time to response Median (months) range (min:max)
Slovenian: Čas do odziva Mediana (meseci) razpon (min:maks)
English: The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila LIBTAYO pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: Guillain-Barre syndrome
Slovenian: Guillain-Barréjev sindrom
English: The physician will provide the Patient Alert Card to each patient.
Slovenian: Zdravnik bo vsakemu bolniku izročil opozorilno kartico za bolnika.
English: 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).
Slovenian: 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).
English: In particular, tell your doctor if you are taking or have ever taken any of the following medicines:
Slovenian: Še posebej morate zdravniku povedati, če jemljete ali ste kadar koli jemali katero od naslednjih zdravil:
English: • LIBTAYO can harm your unborn baby.
Slovenian: • Zdravilo LIBTAYO lahko škoduje vašemu nerojenemu otroku.
English: Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravila LIBTAYO se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: These animal species have similar maternal-foetal interface to that in humans.
Slovenian: Ti dve živalski vrsti imata med materjo in plodom podoben spoj, kot je pri človeku.
English: Patients excluded from clinical studies
Slovenian: Bolniki, ki niso bili vključeni v klinične študije
English: • you have an autoimmune disease (a condition where the body attacks its own cells)
Slovenian: • če imate kakšno avtoimunsko bolezen (avtoimunske bolezni so bolezni, pri katerih telo napade svoje lastne celice),
English: CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
Slovenian: IZ: interval zaupanja, NCP:neodvisen centralni pregled, ND: ni doseženo; +: označuje trajanje ob zadnji ocenitvi.
English: You may have more than one side effect at the same time.
Slovenian: Pojavi se vam lahko več neželenih učinkov istočasno.
English: Based on Kaplan Meier estimates d.
Slovenian: Na podlagi Kaplan-Meierjevih ocen.
English: If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.
Slovenian: Če so viale in/ali intravenske vrečke shranjene v hladilniku, jih je treba pustiti, da pred uporabo dosežejo sobno temperaturo.
English: The event was Grade 3 hypophysitis.
Slovenian: Šlo je za hipofizitis 3. stopnje.
English: It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Slovenian: Znano je, da se protitelesa (tudi IgG4) pri človeku izločajo v materino mleko; tveganja za dojene novorojenčke/dojenčke tako ni mogoče izključiti.
English: • Do not shake the vial.
Slovenian: • Viale ne stresajte.
English: Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.
Slovenian: Zdravnik bo določil, koliko zdravila LIBTAYO boste potrebovali in kolikokrat.