FrancophonIA/ELRC3.0 huggingface dataset:
English: PART III: BETAFERON MEDICATION RECORD
Croatian: Odgođena primjena lijeka Betaferon
English: Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
Croatian: Ako se razine znatno povise ili ako su povezane s kliničkim simptomima poput žutice, treba razmotriti ukidanje terapije lijekom Betaferon.
English: ‘How to store Betaferon' in the first part of this leaflet).
Croatian: Betaferon“ u prvom dijelu upute o lijeku).
English: Asthenia *
Croatian: Malaksalost *
English: After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.
Croatian: Nakon pripreme otopine 1 ml sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b*.
English: − 1 pre-filled syringe of solvent for Betaferon (sodium chloride solution 5.4 mg/ml (0.54% w/v)),
Croatian: (otopina natrijevog klorida (5,4 mg/ml (0,54 % m/V))),
English: B) Getting ready to inject
Croatian: B) Priprema za injiciranje
English: Reconstitution:
Croatian: Rekonstitucija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF THE SINGLE PACK AS AN INTERMEDIATE PACK OF MULTIPACKS OR MULTI-MONTH PACKS (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA POJEDINAČNOG PAKIRANJA KAO SREDNJEG PAKIRANJA VIŠESTRUKOG ILI VIŠEMJESEČNOG
English: This last triple pack should be used for treatment days 19, 21 and 23.
Croatian: Posljednje trostruko pakiranje treba upotrijebiti za dane liječenja 19,
English: Then draw up solution as far as the 1.0 ml mark on the syringe: 1.0 ml for the injections at day 19, 21 and 23 of therapy.
Croatian: 1,0 ml za injekcije na dane liječenja 19, 21 i 23.
English: Cardiomyopathy2
Croatian: Srčani poremećaji tahikardija kardiomiopatija2
English: Musculoskeletal and connective tissue disorders Hypertonia°
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija lupus eritematosus uzrokovan lijekom
English: i.e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “Flu-like symptom complex” denotes flu syndrome and/or a combination of at least two AEs from fever, chills, myalgia, malaise, sweating.
Croatian: § Reakcija na mjestu injiciranja (različite vrste) obuhvaća sve štetne događaje koji se javljaju na mjestu injiciranja, tj. sljedeće termine: krvarenje na mjestu injiciranja, preosjetljivost na mjestu injiciranja, upala na mjestu injiciranja, izraslina na mjestu injiciranja, nekroza na mjestu injiciranja, bol na mjestu injiciranja, reakcija na mjestu injiciranja, edem na mjestu injiciranja i atrofija na mjestu injiciranja
English: Suomi/Finland Bayer Oy
Croatian: Suomi/Finland
English: Betaferon 250 microgram (Placebo) n=317 (n=308)
Croatian: Betaferon mikrograma (placebo) n = 317 (n =
English: Bayer AB
Croatian: Bayer Oy
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg (8 m IU) per ml after reconstitution
Croatian: 250 µg (8 milijuna IU) po ml nakon pripreme otopine
English: Cessation of therapy with Betaferon should be considered (see also sections 4.3 and
Croatian: Betaferon (vidjeti također dijelove 4.3 i 4.8).
English: Separate Annex: INTRODUCTORY LEAFLET FOR TITRATION PACK
Croatian: Odvojeni dodatak: UVODNA UPUTA ZA TITRACIJSKO PAKIRANJE Liječnik Vam je propisao Betaferon za liječenje multiple skleroze.
English: After reconstitution, each millilitre contains 250 microgram (8.0 million IU) interferon beta-1b.
Croatian: Nakon pripreme otopine jedan mililitar sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b.
English: BATCH NUMBER Lot
Croatian: Log-rang test
English: Urinary incontinence
Croatian: Mokraćna inkontencija
English: Drawing up the injection
Croatian: Uvlačenje otopine u injekciju
English: ‘How to use Betaferon' in the first part of the package leaflet and to the Annex 'Self-injection procedure' in the second part of the package leaflet.
Croatian: Za opis pripreme i uporabe praška lijeka Betaferon molimo pogledajte dio 3 „Kako primjenjivati Betaferon“ u prvom dijelu upute o lijeku i Dodatak „Postupak samoinjiciranja“ u drugom dijelu upute o lijeku.
English: − 2-month pack with 2x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − pakiranje za 2 mjeseca s 2x14 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: − 3-month pack with 3x15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − pakiranje za 3 mjeseca s 3x15 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: Abscess
Croatian: Odlaganje
English: sinusitis, cough increased, shortness of breath (dyspnoea) - diarrhoea, constipation, nausea, vomiting, abdominal pain - rises in the blood levels of liver enzymes (will show up in blood tests) - skin disorder, rash - muscle stiffness (hypertonia), painful muscles (myalgia), muscular weakness (myasthenia),
Croatian: - poremećaji kože, osip - ukočenost mišića (hipertonija), bolni mišići (mialgija), slabost mišića (miastenija), bol u leđima, bol u udovima kao što su prsti na nogama i rukama - poteškoće s mokrenjem (zadržavanje mokraće), proteini u mokraći (utvrđuju se analizama mokraće),
English: 43% versus placebo HR = 0.57 [0.46, 0.71] p < 0.00001
Croatian: HR = 0,57 [0,46; 0,71]
English: This equals 250 microgram (8.0 million IU) interferon beta-1b.
Croatian: Jedan ml sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b.
English: Bayer Hungária Kft. Tel.:+36-14 87-41 00
Croatian: Tel.:+36-14 87-41 00
English: Gamma-glutamyltransferase increased, Hepatitis
Croatian: Poremećaji jetre i žuči povišeni bilirubin u krvi povišena razina gama-glutamil transferaze,
English: Lymphadenopathy
Croatian: Limfadenopatija
English: - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests) - inflammation of the liver (hepatitis) - skin discolouration
Croatian: - abnormalno ubrzani srčani otkucaji (tahikardija) - crvenkasto-žuti pigment (bilirubin) kojeg proizvodi Vaša jetra može rasti (to se utvrđuje krvnim pretragama)
English: Bayer Vital GmbH Tel: +49-(0)214-30 513 48
Croatian: Tel: +49-(0)214-30 513 48
English: − multipacks comprising 14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − višestruko pakiranje s 14 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: ► Injection site reactions.
Croatian: Reakcije na mjestu injiciranja.
English: Blood and lymphatic system disorders Lymphocyte count decreased (<1,500/mm³) ×
Croatian: Poremećaji krvi i limfnog sustava anemija trombocitopenija trombotička mikroangiopatija,
English: Tel.: +48-22-572 35 00
Croatian: Bayer Sp. z o.o. Tel.: +48-22-572 35 00
English: − Pack with 5 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − višestruko pakiranje s 5 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: The inactive ingredients of Betaferon include
Croatian: Pomoćne tvari lijeka Betaferon uključuju
English: CLINICAL PARTICULARS
Croatian: POSEBNE MJERE ČUVANJA
English: − Pack with 12 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − pakiranje s 12 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: Skin and subcutaneous tissue disorders Skin disorder
Croatian: Poremećaji bubrega i mokraćnog sustava Retencija mokraće
English: Psychiatric disorders Depression
Croatian: Depresija Anksioznost
English: − multipacks comprising 12 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − višestruko pakiranje s 12 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: Müllerstraße 178 13353 Berlin Germany
Croatian: 13353 Berlin
English: − multipacks comprising 15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Croatian: − višestruko pakiranje s 15 pojedinačnih pakiranja od kojih svako sadrži 1 bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu s iglom, 2 tupfera natopljena alkoholom ili
English: A) General advice
Croatian: Opći savjet
English: Dizziness
Croatian: Betaferon
English: Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Croatian: Poremećaji metabolizma i prehrane povećanje težine,
English: 6.1 List of excipients:
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: Use the blue triple pack 4 containing 3 syringes with a 0.25; 0.5; 0.75 and 1.0-ml marking, for treatment days 19, 21 and 23.
Croatian: Potom nastavite s plavim trostrukim pakiranjem 4 koje sadrži 3 štrcaljke s oznakom od 0,25, 0,50, 0,75 i 1,0
English: 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.
Croatian: Otapalo za pripremu otopine lijeka Betaferon 1,2 ml otopine natrijevog klorida od 5,4 mg/ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.
Croatian: 1 ml sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b nakon pripreme otopine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF MULTIPACK AS AN INTERMEDIATE PACK OF MULTI-MONTH PACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S VIŠE PAKIRANJA KAO SREDNJE PAKIRANJE VIŠEMJESEČNOG
English: Hypothyroidism
Croatian: Hipertonija
English: For details on storage conditions, see section 5.
Croatian: − Za pojedinosti u vezi s čuvanjem pogledajte dio 5. „Kako čuvati Betaferon“ ove upute o lijeku.
English: Gastrointestinal disorders Diarrhoea
Croatian: Poremećaji probavnog sustava pankreatitis
English: Manufacturer Bayer AG
Croatian: UAB Bayer
English: Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakiranje
English: 30 minutes.
Croatian: 30 minuta.
English: Date of first authorisation: 17 July 2015
Croatian: Datum prvog odobrenja: 17. srpnja 2015.
English: Talk to your doctor if you are not sure.
Croatian: Obratite se svom liječniku ukoliko niste sigurni.
English: - Your doctor will decide how many treatments you need.
Croatian: - Vaš će liječnik odlučiti koliko ciklusa liječenja trebate primiti.
English: *p-Value is nominal.
Croatian: *p-vrijednost je nominalna.
English: Time in Months
Croatian: Vrijeme u mjesecima
English: - If you are taking, have recently taken or might take any other medicines.
Croatian: Ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: You may experience more than one side effect at the same time.
Croatian: Možete imati i više od jedne nuspojave u isto vrijeme.
English: NA = not available
Croatian: ND = nije dostupno
English: Otherwise treatment should be discontinued.
Croatian: U protivnom, liječenje treba prekinuti.
English: - It is very important that you do not miss a dose of this medicine.
Croatian: - Vrlo je važno da ne propustite primiti dozu ovog lijeka.
English: It is available in cartons containing one glass vial.
Croatian: Dostupna je u kutijama koje sadrže jednu staklenu bočicu.
English: (see Table 22).
Croatian: (vidjeti Tablicu 22).
English: Data from these patients are too limited to draw any conclusion on safety or efficacy in this population.
Croatian: Podaci dobiveni od tih bolesnika su previše ograničeni za izvođenje bilo kakvih zaključaka o sigurnosti i djelotvornosti u toj populaciji.
English: Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms.
Croatian: Vaš liječnik Vam može dati druge lijekove kako bi se spriječile teže komplikacije i smanjili simptomi.
English: A total of 559 patients were randomised.
Croatian: Ukupno je randomizirano 559 bolesnika.
English: These side effects may happen anytime during treatment or even after your treatment has ended.
Croatian: Ove se nuspojave mogu dogoditi bilo kada za vrijeme liječenja ili čak nakon što je Vaše liječenje završilo.
English: These complications can be severe and can lead to death.
Croatian: Ove komplikacije mogu biti teške i mogu dovesti do smrtnog ishoda.
English: • Do not co-administer other medicinal products through the same infusion line.
Croatian: • Nemojte istodobno primjenjivati druge lijekove istom infuzijskom linijom.
English: Number at Risk
Croatian: Broj pod rizikom
English: All but two patients were white.
Croatian: Svi osim dvoje bolesnika bili su bijelci.
English: What KEYTRUDA is and what it is used for
Croatian: Što je KEYTRUDA i za što se koristi
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Croatian: Važno je sačuvati tu Karticu s upozorenjima i pokazati je svom partneru ili osobama koje skrbe za Vas.
English: All but one patient was white.
Croatian: Svi osim jednog bolesnika bili su bijelci.
English: - It is important that you keep the Alert Card with you during treatment.
Croatian: - Važno je sačuvati Karticu s upozorenjima za vrijeme Vašeg liječenja.
English: Allow up to 5 minutes for the bubbles to clear.
Croatian: Pričekajte do 5 minuta kako bi mjehurići nestali.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: Number (%
Croatian: Broj (%
English: Do not Freeze.
Croatian: Ne zamrzavati.
English: Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2
Croatian: Eastern Cooperative Oncology Group) status ≥2
English: Based on severity and type of reaction (Grade 2 or Grade 3)
Croatian: Ovisno o težini i vrsti reakcije (2. stupanj ili 3. stupanj)
English: ATC code: L01XC18
Croatian: ATK oznaka: L01XC18
English: Patients without disease progression could be treated for up to 24 months.
Croatian: Bolesnike bez progresije bolesti moglo se liječiti do najviše 24 mjeseca.
English: KEYTRUDA is used in adults to treat:
Croatian: KEYTRUDA se koristi u odraslih osoba za liječenje:
English: Common severe skin reactions s,
Croatian: Često teške kožne reakcije s,
English: Children and adolescents KEYTRUDA should not be used in children and adolescents below 18 years of age.
Croatian: Djeca i adolescenti KEYTRUDA se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: There were no Grade 5 hepatic events.
Croatian: Nije bilo jetrenih događaja 5. stupnja.
English: (n=84), or vinflunine 320 mg/m
Croatian: (n=84) ili vinflunin 320 mg/m
English: The potential risk of gastrointestinal perforation should be taken into consideration.
Croatian: Treba razmotriti potencijalni rizik od gastrointestinalne perforacije.
English: • The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first
Croatian: • Važnost toga da bolesnik ne pokušava samostalno liječiti nikakve simptome bez prethodnog savjetovanja sa svojim zdravstvenim radnikom
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: Ove podatke ćete također naći i u Kartici s upozorenjima za bolesnika koju Vam je dao Vaš liječnik.
English: They may occur if you had this kind of transplant in the past or if you get it in the future.
Croatian: Mogu se javiti ako ste ovu vrstu presađivanja primili u prošlosti ili ako joj se podvrgnete u budućnosti.
English: This can affect your ability to drive or to use machines.
Croatian: To može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Duration of Response
Croatian: Trajanje odgovora
English: • KEYTRUDA is for single use only.
Croatian: • KEYTRUDA je namijenjena isključivo za jednokratnu uporabu.
English: The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Croatian: Kartica podsjeća bolesnike na najvažnije simptome koje odmah moraju prijaviti liječniku/medicinskoj sestri.
English: Warnings and precautions Talk to your doctor or nurse before receiving KEYTRUDA.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek KEYTRUDA.
English: Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful.
Croatian: Na temelju dostupnih podataka o sigurnosti primjene kod kHL-a i drugih vrsta tumora, te razlike nisu klinički značajne.
English: A total of 861 patients were randomised.
Croatian: Ukupno je randomiziran 861 bolesnik.
English: Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well.
Croatian: Nemojte upravljati vozilima ni raditi sa strojevima nakon što primite lijek KEYTRUDA, osim ako ste posve sigurni da se osjećate dobro.
English: Hepatitis resolved in 36 patients.
Croatian: Hepatitis se povukao u 36 bolesnika.
English: The patient educational material should contain:
Croatian: Edukacijski materijal za bolesnika mora sadržavati:
English: • 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).
Croatian: • Važnost toga da bolesnik uvijek sa sobom nosi Karticu s upozorenjima za bolesnika i pokaže je pri svakom posjetu drugim zdravstvenim radnicima osim onom koji mu je propisao lijek (npr. zdravstvenim radnicima u hitnoj službi).
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); and not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The KEYNOTE-426 trial was not powered to evaluate efficacy of individual subgroups.
Croatian: Ispitivanje KEYNOTE-426 nije imalo statističku snagu za ocjenu djelotvornosti u pojedinačnim podskupinama.
English: PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months.
Croatian: Rezultati za PFS i ORR prijavljeni su iz interim analize provedene nakon medijana praćenja od 11 mjeseci.
English: These results should be interpreted in the context of the open-label study design and therefore taken cautiously.
Croatian: Te podatke treba tumačiti u kontekstu otvorenog dizajna ispitivanja i razmatrati ih uz oprez.
English: The Patient Information Brochure and Patient Alert Card shall contain the following key elements:
Croatian: Knjižica s informacijama za bolesnika i Kartica s upozorenjima za bolesnika sadržavat će sljedeće ključne elemente:
English: When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations.
Croatian: Pri ocjenjivanju PD-L1 statusa tumora važno je odabrati dobro validiranu i robusnu metodologiju kako bi se minimizirala mogućnost lažno negativnih ili lažno pozitivnih nalaza.
English: It is important that you also read the package leaflets for these other medicines.
Croatian: Važno je da pročitate upute o lijeku i za te druge lijekove.
English: Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Croatian: Kako je poznato da se protutijela mogu izlučiti u majčino mlijeko, ne može se isključiti rizik za novorođenče.
English: Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Croatian: Primijećeni su netipični odgovori (tj. početno prolazno povećanje veličine tumora ili nastanak novih malih lezija unutar prvih nekoliko mjeseci, nakon čega je uslijedilo smanjenje tumora).
English: 28.0 (14, not available)
Croatian: 28,0 (14, nije dostupno)
English: KEYTRUDA works by helping your immune system fight your cancer.
Croatian: KEYTRUDA djeluje tako da pomaže Vašem imunološkom sustavu u borbi protiv raka.
English: The educational programme is aimed at increasing the awareness of patients and/or their caregivers on the signs and symptoms relevant to the early recognition/identification of the potential immunerelated adverse reactions (irARs).
Croatian: Edukacijski program namijenjen je povećanju svijesti bolesnika i/ili njihovih skrbnika o znakovima i simptomima važnima za rano prepoznavanje/identifikaciju mogućih imunološki uzrokovanih nuspojava.
English: Efficacy results based on an additional seven months of follow-up are summarized in Table 10 and Figure 4.
Croatian: Rezultati za djelotvornost bazirani na 7 dodatnih mjeseci praćenja sažeto su prikazani u Tablici 10 i na Slici 4.
English: Severe skin reactions resolved in 64 patients.
Croatian: Teške kožne reakcije povukle su se u 64 bolesnika.
English: Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Croatian: Terapiju moraju započeti i nadzirati liječnici specijalisti s iskustvom u liječenju raka.
English: These side effects can sometimes become life-threatening and can lead to death.
Croatian: Ove nuspojave mogu ponekad biti opasne po život i mogu dovesti do smrti.
English: In 20 subjects with ocular melanoma included in KEYNOTE-001, no objective responses were reported; stable disease was reported in 6 patients.
Croatian: U 20 ispitanika s očnim melanomom uključenih u ispitivanje KEYNOTE-001 nije prijavljen nijedan objektivan odgovor; stabilna je bolest prijavljena u 6 bolesnika.
English: As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner.
Croatian: Kao što se i očekuje za protutijela, pembrolizumab se ne vezuje za proteine u plazmi na specifičan način.
English: Grade 4 or confirmed SJS or TEN Permanently discontinue
Croatian: 4. stupanj ili potvrđeni SJS ili TEN Trajno prekinuti
English: Not reached
Croatian: Nije dosegnut
English: Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8).
Croatian: Dok ne bude dostupno više podataka, potrebno je pažljivo razmotriti potencijalne koristi HSCT-a i mogući povećan rizik od komplikacija povezanih s transplantacijom u svakom pojedinom slučaju (vidjeti dio 4.8).
English: These medicines may interfere with the effect of KEYTRUDA.
Croatian: Ovi lijekovi mogu utjecati na učinak lijeka KEYTRUDA.
English: In addition, no safety and efficacy data are available in frailer patients (e.g., ECOG performance status 3) considered not eligible for chemotherapy.
Croatian: Nadalje, nema dostupnih podataka o sigurnosti i djelotvornosti u onemoćalih bolesnika (npr. funkcionalni ECOG status 3) za koje se smatralo da nisu pogodni za primanje kemoterapije.
English: The safety and efficacy of KEYTRUDA in children below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka KEYTRUDA u djece mlađe od 18 godina nisu još ustanovljene.