FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
Croatian: NAZIV LIJEKA GIOTRIF 30 mg tablete afatinib
English: GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Croatian: GIOTRIF 30 mg filmom obložene tablete EU/1/13/879/004
English: They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Imaju utisnutu oznaku “T20” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
English: GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Croatian: GIOTRIF 20 mg filmom obložene tablete EU/1/13/879/001
English: Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
Croatian: Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
Croatian: NAZIV LIJEKA GIOTRIF 40 mg tablete afatinib
English: 6.9 vs. 3.4 HR 0.70; p=0.0220 values presented for GIOTRIF vs. chemotherapy, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test
Croatian: vrijednosti predstavljene za GIOTRIF naspram kemoterapije; p-vrijednost temeljena na logističkoj regresiji p-vrijednost za vrijeme do pogoršanja temeljena na stratificiranom log-rank testu
English: GIOTRIF 40 mg film-coated tablets afatinib
Croatian: GIOTRIF 40 mg filmom obložene tablete afatinib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 30 mg)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 20 mg filmom obložene tablete afatinib
English: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Tamnoplava, ovalna, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T50” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
English: They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Imaju utisnutu oznaku “T50” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
English: GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
Croatian: GIOTRIF 40 mg filmom obložene tablete EU/1/13/879/007
English: Dyspepsia
Croatian: Dispneja
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 40 mg)
English: GIOTRIF 50 mg film-coated tablets afatinib
Croatian: GIOTRIF 50 mg filmom obložene tablete afatinib
English: They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Imaju utisnutu oznaku “T30” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
English: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Svijetloplava, okrugla, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T40” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 30 mg filmom obložene tablete afatinib
English: OS Months (median)
Croatian: Medijan OS-a (mjeseci)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 40 mg filmom obložene tablete afatinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg afatinib (as dimaleate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 40 mg afatinib (as dimaleate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 50 mg film-coated tablets afatinib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 50 mg filmom obložene tablete afatinib
English: Conjunctivitis Dry eye
Croatian: Konjunktivitis Sindrom suhog oka Keratitis
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/001
English: Liver function test abnormalities
Croatian: Poremećaji testova jetrene funkcije
English: They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Croatian: Imaju utisnutu oznaku “T40” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg afatinib (as dimaleate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
English: The primary endpoint was PFS as assessed by central independent review; secondary endpoints included OS and ORR.
Croatian: Primarni ishod je bio PFS na temelju središnje nezavisne procjene; sekundarni ishodi su uključivali ukupno preživljenje (engl. overall survival, OS) i stopu objektivnog odgovora (engl. objective response rate, ORR).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/004
English: titanium dioxide (E171), talc (E553b), polysorbate 80 (E433).
Croatian: GIOTRIF 30, 40 i 50 mg filmom obložene tablete hipromeloza (E464) makrogol 400 titanijev dioksid (E171) talk (E553b) polisorbat 80 (E433) indigo carmine aluminijev hidroksid (E132)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/007
English: Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Epistaksa
English: Cough
Croatian: Spol
English: MA (EU)Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Immediate Packaging
Croatian: Put primjene Unutarnje pakovanje Veličina pakovanja
English: For any of the following:
Croatian: Za bilo što od sljedećeg:
English: Events (%)
Croatian: događaji (%)
English: Do not try to treat yourself with other medicines.
Croatian: Nemojte pokušavati sami sebe liječiti drugim lijekovima.
English: 30th January 2020
Croatian: 30. siječnja
English: After opening
Croatian: Nakon otvaranja
English: Bavencio can cause harm to your unborn baby.
Croatian: Bavencio može naštetiti Vašem nerođenom djetetu.
English: • Do not co-administer other medicinal products through the same intravenous line.
Croatian: • Nemojte istodobno primjenjivati druge lijekove kroz istu intravensku liniju.
English: (18, not estimable)
Croatian: (18, nije se moglo procijeniti)
English: • give you other medicines in order to prevent complications and reduce your symptoms,
Croatian: • dati druge lijekove kako bi se spriječile komplikacije i ublažili simptomi
English: • Brief introduction to avelumab (indication and purpose of this tool)
Croatian: • Kratak uvod u avelumab (indikacija i svrha ove kartice)
English: Your doctor will decide how many treatments you need.
Croatian: Vaš će liječnik odlučiti koliko puta trebate primiti terapiju.
English: You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor.
Croatian: Bavencio ćete primati u bolnici ili klinici, pod nadzorom iskusnog liječnika.
English: • Feeling cold
Croatian: • osjećaj hladnoće
English: • you have had an organ transplant.
Croatian: • imate presađen organ.
English: Bavencio is used in adults to treat:
Croatian: Bavencio se primjenjuje u odraslih za liječenje:
English: If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines.
Croatian: Ako osjetite bilo koje od ovih simptoma dok uzimate Bavencio, ne pokušavajte ih sami liječiti drugim lijekovima.
English: Time to response (TTR)
Croatian: Vrijeme do odgovora (TTR)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja do primjene odgovornost su korisnika.
English: You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment.
Croatian: Obavljat ćete krvne pretrage tijekom liječenja i liječnik će pratiti Vašu tjelesnu težinu prije i tijekom liječenja.
English: Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Croatian: Potražite hitnu medicinsku pomoć ako dobijete upalu u bilo kojem dijelu tijela ili ako imate bilo koji od sljedećih znakova ili simptoma ili ako se oni pogoršavaju.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Croatian: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Švicarska
English: Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Croatian: Nemojte upravljati vozilima ili raditi sa strojevima nakon što ste primili Bavencio ako se ne osjećate dovoljno dobro.
English: The patient educational material should contain
Croatian: Edukacijski materijal za bolesnika mora sadržavati
English: • Inflammatory reaction of the whole body (Systemic inflammatory response syndrome)
Croatian: • upalna reakcija cijelog tijela (sindrom sistemskog upalnog odgovora)
English: Total systemic clearance increases with body weight.
Croatian: Ukupni sistemski klirens povećava se s tjelesnom težinom.
English: Some side effects may happen weeks or months after your last dose.
Croatian: Neke nuspojave mogu nastati tjednima ili mjesecima nakon zadnje doze.
English: Contents of the pack and other information What Bavencio contains
Croatian: Sadržaj pakiranja i druge informacije Što Bavencio sadrži
English: (10.2, not estimable)
Croatian: (10,2; nije se moglo procijeniti)
English: Suspected pneumonitis should be confirmed with radiographic imaging.
Croatian: Sumnju na pneumonitis treba potvrditi rendgenskom snimkom.
English: Blood tests and weight checks:
Croatian: Krvne pretrage i provjere tjelesne težine:
English: Any partially used or empty vials have to be discarded.
Croatian: Sve djelomično upotrijebljene ili prazne bočice treba baciti.
English: The treatment is directed to the management of symptoms.
Croatian: Liječenje je usmjereno na zbrinjavanje simptoma.
English: Bavencio has not been studied in children and adolescents below 18 years of age.
Croatian: Bavencio nije ispitan u djece i adolescenata mlađih od 18 godina.
English: Dose escalation or reduction is not recommended.
Croatian: Ne preporučuje se povisivati ili snižavati dozu.
English: Your doctor will check your general health before and during treatment with Bavencio.
Croatian: Liječnik će provjeriti Vaše opće zdravlje prije i tijekom liječenja lijekom Bavencio.
English: What Bavencio is and what it is used for
Croatian: Što je Bavencio i za što se koristi
English: Patients excluded from clinical studies
Croatian: Bolesnici isključeni iz kliničkih ispitivanja
English: * 1-sided p-value based on stratified log-rank.
Croatian: * jednostrana p-vrijednost na temelju stratificiranog log-ranga.
English: Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before all of your Bavencio treatments.
Croatian: Ovisno o odgovoru Vašeg tijela na liječenje, liječnik može odlučiti da Vam nastavi davati ove lijekove svaki put prije nego što primite Bavencio.
English: Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Croatian: Budući da je poznato da se protutijela mogu izlučivati u majčino mlijeko, ne može se isključiti rizik za novorođenče/dojenče.
English: Bavencio is for intravenous infusion only.
Croatian: Bavencio je samo za intravensku infuziju.
English: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Bavencio u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Other medicines and Bavencio
Croatian: Drugi lijekovi i Bavencio
English: BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable.
Croatian: Blinded Independent Central Review); CI: raspon pouzdanosti; NE: ne može se procijeniti.
English: • you have an autoimmune disease (a condition where the body attacks its own cells);
Croatian: • imate autoimunu bolest (stanje u kojem tijelo napada vlastite stanice)
English: Some side effects may not have symptoms and may only be discovered through blood tests.
Croatian: Neke nuspojave ne moraju imati simptome i mogu se otkriti samo krvnim pretragama.
English: Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space.
Croatian: Očekuje se da će se avelumab distribuirati u sistemsku cirkulaciju i u manjoj mjeri u izvanstanični prostor.
English: Do not freeze or shake the diluted solution.
Croatian: Ne zamrzavati ili tresti razrijeđenu otopinu.
English: The volume of distribution at steady state was 4.72 L.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže iznosio je 4,72 l.
English: IHC-MCV tumour status
Croatian: IHC-MCV tumorski status
English: 2.3 months).
Croatian: 13 mjeseci).
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Bavencio.
Croatian: • Kartica također treba imati prostor za unos podataka za kontakt liječnika i uključivati poruku s upozorenjem za zdravstvene radnike koji u bilo kojem trenutku liječe bolesnika, uključujući hitne situacije, da bolesnik primjenjuje Bavencio.
English: If you suffer from any of these you should seek urgent medical attention:
Croatian: Ako primijetite neki od ovih simptoma, morate potražiti hitnu medicinsku pomoć:
English: It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Croatian: Ne preporučuje se primjenjivati avelumab tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje avelumabom.
English: Please note that in some cases symptoms may be delayed, and may develop after your last dose.
Croatian: Imajte na umu da se ovi simptomi ponekad kasno javljaju i mogu se razviti i nakon zadnje doze.
English: Bavencio acts on your immune system and may cause inflammation in parts of your body (see section 2).
Croatian: Bavencio djeluje na Vaš imunološki sustav i može uzrokovati upalu u raznim dijelovima tijela (pogledajte dio 2).
English: Patients should be advised to use caution when driving or operating machinery until they are certain that avelumab does not adversely affect them.
Croatian: Bolesnicima treba savjetovati da budu oprezni pri upravljaju vozilima ili radu sa strojevima sve dok ne budu sigurni da avelumab nema štetan utjecaj na njih.
English: The pack size is 1 glass vial per carton.
Croatian: Veličina pakiranja je 1 staklena bočica po kutiji.
English: Many of the male monkeys used in these studies were sexually immature and thus no explicit conclusions regarding effects on male reproductive organs can be made.
Croatian: Mnogi mužjaci majmuna u ovim ispitivanjima nisu bili spolno zreli pa se stoga ne mogu donijeti nikakvi jasni zaključci o učincima na muške reproduktivne organe.
English: Hepatotoxicity (in combination with axitinib)
Croatian: Hepatotoksičnost (u kombinaciji s aksitinibom)
English: Forty-seven (53%) of the patients had visceral metastases.
Croatian: Četrdeset i sedam (53 %) bolesnika imalo je visceralne metastaze.
English: Patients were randomised (1:1) to one of the following treatment arms:
Croatian: Bolesnici su bili randomizirani (1:1) u jednu od sljedećih terapijskih skupina:
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of avelumab (see “Description of selected adverse reactions” below).
Croatian: Većina ih se, uključujući teške reakcije, povuče nakon uvođenja odgovarajuće medikamentozne terapije ili obustave primjene avelumaba (vidjeti “Opis odabranih nuspojava” niže).
English: The efficacy endpoints were based on 29 patients with 13 weeks of follow-up.
Croatian: Mjere ishoda djelotvornosti bile su temeljene na 29 bolesnika praćenih 13 tjedana.
English: Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity.
Croatian: Lijek Bavencio treba nastaviti primjenjivati prema preporučenom rasporedu sve do progresije bolesti ili neprihvatljive toksičnosti.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Rizik za dojenče ne može se isključiti.
English: Fertility The effect of avelumab on male and female fertility is unknown.
Croatian: Plodnost Učinak avelumaba na mušku i žensku plodnost nije poznat.
English: Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Croatian: Nemojte prestati s liječenjem lijekom Bavencio osim ako o tome niste razgovarali s liječnikom.
English: As expected for an antibody, avelumab does not bind to plasma proteins in a specific manner.
Croatian: Kao što se i očekuje za protutijelo, avelumab se ne veže specifično za proteine plazme.
English: • you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
Croatian: • imate infekciju virusom humane imunodeficijencije (HIV) ili sindrom stečene imunodeficijencije (SIDA)
English: The Patient Alert Card shall contain the following key messages:
Croatian: Kartica s upozorenjima za bolesnika sadržavat će sljedeće ključne poruke:
English: • Reminder to carry the Patient Alert Card at all times and to show it to all healthcare professionals that may treat them.
Croatian: • Podsjetnik da karticu s upozorenjima za bolesnika uvijek nose sa sobom i da je pokažu svim zdravstvenim radnicima koji bi ih mogli liječiti.
English: Date of first authorisation: 18 September 2017 Date of latest renewal: 20 June 2019
Croatian: Datum posljednje obnove odobrenja: 20. lipnja 2019.
English: It must not be administered as an intravenous push or bolus injection.
Croatian: Ne smije se primijeniti kao brza intravenska ili bolus injekcija.
English: Check with your doctor or nurse before you receive Bavencio if:
Croatian: Provjerite s liječnikom ili medicinskom sestrom prije nego što primite Bavencio ako:
English: Confirmed pancreatitis
Croatian: Potvrđeni pankreatitis
English: Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
Croatian: Nemojte čuvati neprimijenjeni dio koncentrata ili razrijeđene infuzijske otopine za ponovnu primjenu.
English: Conditional approval
Croatian: Uvjetno odobrenje
English: If you have any questions about axitinib, ask your doctor.
Croatian: Ako imate pitanja o aksitinibu, obratite se liječniku.
English: Although there was no clear dose-response relationship, it cannot be excluded that this finding was related to avelumab treatment.
Croatian: Iako nije bilo jasne povezanosti doze i odgovora, ne može se isključiti da je ovaj nalaz povezan s liječenjem avelumabom.
English: What Bavencio looks like and contents of the pack
Croatian: Kako Bavencio izgleda i sadržaj pakiranja
English: The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Croatian: Raspon pH otopine je 5,0 - 5,6, a osmolalnost između 270 i 330 mOsm/kg.
English: Therefore, avelumab has the potential to be transmitted from the mother to the developing foetus.
Croatian: Stoga se avelumab može prenijeti s majke na fetus u razvoju.
English: The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression.
Croatian: bolesnika (n=160, 71,4 %) s progresivnom bolešću nastavila je liječenje s oba lijeka i nakon progresije.
English: For Part A, an efficacy analysis was conducted in all 88 patients after a minimum follow-up of 36 months.
Croatian: U dijelu A, analiza djelotvornosti provedena je u svih 88 bolesnika nakon minimalnog praćenja od 36 mjeseci.
English: Women of childbearing potential/Contraception
Croatian: Žene reproduktivne dobi / kontracepcija
English: If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Croatian: Ako četvrta infuzija završi bez reakcija povezanih s infuzijom, premedikaciju prije sljedećih doza treba primjenjivati prema procjeni liječnika.
English: You will receive Bavencio as an infusion (a drip) into a vein (intravenously) over a period of 1 hour.
Croatian: Bavencio ćete primati kao infuziju (drip) u venu (intravenski) u trajanju od 1 sata.
English: Talk to your doctor before receiving Bavencio:
Croatian: Obratite se svom liječniku prije nego što primite Bavencio:
English: The patients had no symptoms, did not require any treatment for the overdose, and continued on avelumab therapy.
Croatian: Bolesnici nisu imali simptome, nije im bilo potrebno nikakvo liječenje zbog predoziranja i nastavili su s terapijom avelumabom.
English: Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Croatian: Dvadeset i dvoje od 29 (76 %) bolesnika s odgovorom odgovorilo je unutar 7 tjedana nakon prve doze avelumaba.
English: With a median OS follow-up of 19 months, OS data were immature with 27% deaths.
Croatian: Uz medijan praćenja OS-a od 19 mjeseci, podaci za OS nisu bili spremni za analizu, s 27 % smrtnih slučajeva.
English: Consistent with a limited extravascular distribution, the volume of distribution of avelumab at steady state is small.
Croatian: Sukladno ograničenoj ekstravaskularnoj distribuciji, volumen distribucije avelumaba u stanju dinamičke ravnoteže je malen.
English: Adrenal insufficiency
Croatian: Adrenalna insuficijencija
English: The diluted solution should be used immediately once prepared.
Croatian: Razrijeđenu otopinu treba primijeniti odmah nakon pripreme.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Croatian: U 1-mjesečnom i 3-mjesečnom ispitivanju toksičnosti ponovljenih doza u majmuna nije bilo primjetnih učinaka na ženske reproduktivne organe.
English: Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 20°C to 25°C and room light.
Croatian: Dokazano je da je razrijeđena otopina u primjeni kemijski i fizikalno stabilna 24 sata na temperaturi od 20 °C do 25 °C i uz sobno osvjetljenje.
English: Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Croatian: Avelumab se veže na PD-L1 i blokira interakciju PD-L1 i receptora 1 programirane smrti stanice (PD-1) i receptora B7.1.
English: Based on a population pharmacokinetic analysis from 1,629 patients, the value of total systemic clearance (CL) is 0.59 L/day.
Croatian: Na temelju analize populacijske farmakokinetike u 1629 bolesnika, vrijednost ukupnog sistemskog klirensa je 0,59 l/dan.