FrancophonIA/ELRC3.0 huggingface dataset:
English: Osimertinib should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia.
Croatian: Osimertinib treba trajno prekinuti u bolesnika u kojih dođe do kombinacije produljenja QTc intervala i bilo čega sljedećeg: torsade de pointes, polimorfna ventrikularna tahikardija, znakovi/simptomi ozbiljne aritmije.
English: However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see section 5.3).
Croatian: Međutim, osimertinib i njegovi metaboliti otkriveni su u štenaca koji sisaju te su postojali štetni učinci na rast štenaca i preživljenje (vidjeti dio 5.3).
English: Results from animal studies have shown that osimertinib has effects on male and female reproductive organs and could impair fertility (see section 5.3).
Croatian: Rezultati ispitivanja na životinjama pokazali su da osimertinib ima učinke na muške i ženske reproduktivne organe te da može smanjiti plodnost (vidjeti dio 5.3).
English: TAGRISSO has no or negligible influence on the ability to drive and use machines.
Croatian: TAGRISSO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.'
Croatian: TAGRISSO se koristi u liječenju odraslih osoba s vrstom raka pluća nazvanim „rak pluća nemalih stanica“.
English: Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy.
Croatian: Analiza mjera ishoda nakon progresije bolesti pokazala je da su se korisni učinci na PFS održali i tijekom sljedećih linija liječenja.
English: Following a single oral dose of 20 mg, 67.8% of the dose was recovered in faeces (1.2% as parent) while 14.2% of the administered dose (0.8% as parent) was found in urine by 84 days of sample collection.
Croatian: Nakon jednokratne peroralne doze od 20 mg, 67,8% doze izlučuje se u fecesu (1,2% u obliku ishodišnog spoja), dok je 14,2% primijenjene doze (0,8% u obliku ishodišnog spoja) pronađeno u urinu do 84. dana prikupljanja uzoraka.
English: The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%).
Croatian: Najčešće prijavljivane nuspojave bile su proljev (49%) i osip (47%).
English: The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes.
Croatian: Dobivenih 30 ml tekućine treba primijeniti u skladu s uputama proizvođača nazogastrične sonde, uz odgovarajuće ispiranje vodom.
English: In a modified embryofoetal development study in the rat, osimertinib caused embryolethality when administered to pregnant rats prior to embryonic implantation.
Croatian: U modificiranom ispitivanju embriofetalnog razvoja u štakora, osimertinib je uzrokovao embrioletalnost kada se primjenjivao u gravidnih ženki štakora prije implantacije embrija.
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1).
Croatian: Bolesnike u kojih se pojave znakovi i simptomi koji upućuju na keratitis, kao što su akutni nastup ili pogoršanje crvenila oka, suzenja, osjetljivosti na svjetlost, zamagljena vida, boli u oku i/ili crvenila oka, treba odmah uputiti specijalistu oftalmologije (vidjeti Tablicu 1 u dijelu 4.2).
English: The absolute bioavailability of TAGRISSO is 70% (90% CI 67, 73).
Croatian: Apsolutna bioraspoloživost lijeka TAGRISSO iznosi 70% (90% CI: 67, 73).
English: Based on population pharmacokinetic analysis, osimertinib apparent plasma clearance is 14.3 L/h, apparent volume of distribution is 918 L and terminal half-life of approximately 44 hours.
Croatian: Temeljeno na analizi populacijske farmakokinetike, prividni klirens osimertiniba u plazmi je 14,3 l/h, prividni volumen distribucije je 918 l i terminalni poluvijek je približno 44 sata.
English: What you need to know before you take TAGRISSO
Croatian: Što morate znati prije nego počnete uzimati TAGRISSO
English: See ‘Serious side effects' in section 4 for more information.
Croatian: Za više informacija pogledajte „Ozbiljne nuspojave“ u dijelu 4.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava, nuspojave su navedene po učestalosti, uz najčešće nuspojave navedene prve.
English: Other side effects Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: 30 x 1 film-coated tablets 28 x 1 film-coated tablets
Croatian: 30 x 1 filmom obložena tableta 28 x 1 filmom obložena tableta
English: Thirty-one percent (31%) (N=129) had received 1 prior line of therapy (EGFR-TKI treatment only), 69% (N=282) had received 2 or more prior lines.
Croatian: Trideset i jedan posto (31%) njih (N=129) je primilo 1 prethodnu liniju liječenja (samo inhibitor tirozin kinaze EGFR-a), dok je njih 69% (N=282) primilo 2 ili više prethodnih linija liječenja.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete TAGRISSO.
English: Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje lijekom TAGRISSO treba započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: • Aliskiren-used for high blood pressure.
Croatian: • Aliskiren - koristi se za liječenje visokog krvnog tlaka.
English: Patients received study therapy until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Croatian: Bolesnici su primali ispitivanu terapiju sve dok je nisu prestali podnositi ili dok ispitivač nije utvrdio da više ne ostvaruju kliničku korist.
English: This leads to inhibition of cell growth, while showing significantly less activity against EGFR in wild-type cell lines (apparent IC50s from 480 nM to 1.8 μM against phospho-EGFR).
Croatian: To dovodi do inhibicije rasta stanica, istodobno pokazujući značajno manje aktivnosti spram EGFR-a u staničnim linijama divljeg tipa (utvrđene vrijednosti IC50 od 480 nM do 1,8 µM za fosfo-EGFR).
English: These patients received TAGRISSO at a dose of 80 mg daily in two randomised Phase 3 studies (FLAURA, first line and AURA3, second line only), two single-arm studies (AURAex and AURA2, second line or greater) and one Phase 1 study (AURA1, first-line or greater) (see section 5.1).
Croatian: Ti su bolesnici primali TAGRISSO u dozi od 80 mg dnevno u dva randomizirana ispitivanja faze 3 (FLAURA - prva linija, i AURA3 - samo druga linija), dva ispitivanja s jednom skupinom (AURAex i AURA2 - druga ili kasnija linija) i jednom ispitivanju faze 1 (AURA1 - prva ili kasnija linija) (vidjeti dio 5.1).
English: Based on in vitro studies, 2 pharmacologically active metabolites (AZ7550 and AZ5104) have subsequently been identified in the plasma of preclinical species and in humans after oral dosing with osimertinib; AZ7550 showed a similar pharmacological profile to TAGRISSO while AZ5104 showed greater potency across both mutant and wild-type EGFR.
Croatian: Na temelju in vitro ispitivanja, naknadno su identificirana 2 farmakološki aktivna metabolita (AZ7550 i AZ5104) u plazmi nekliničkih vrsta i u ljudi, nakon peroralne primjene osimertiniba; AZ7550 pokazuje sličan farmakološki profil kao i TAGRISSO, dok AZ5104 ima veću potentnost i za mutirani i za divlji tip EGFR-a.
English: Both metabolites appeared slowly in plasma after administration of TAGRISSO to patients, with a median (min-max) tmax of 24 (4-72) and 24 (6-72) hours, respectively.
Croatian: Oba su se metabolita pojavila sporo u plazmi bolesnika nakon primjene lijeka TAGRISSO, uz medijan (min-max) tmax od 24 (4-72) odnosno 24 (6-72) sata.
English: Pulmonary ILD/Pneumonitis
Croatian: Plućni Intersticijska bolest pluća/pneumonitis
English: Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status of tumour derived DNA (from a tissue or a plasma sample) should be used.
Croatian: Smiju se koristiti samo robusni, pouzdani i osjetljivi testovi koji su dokazano korisni za određivanje statusa mutacije EGFR-a u tumorskoj DNK (iz uzorka tkiva ili plazme).
English: This analysis demonstrated a consistent treatment effect (HR 0.28; 95% CI: 0.20, 0.38) with that observed by investigator assessment.
Croatian: Analiza je pokazala terapijski učinak (HR 0,28; 95% CI: 0,20; 0,38) koji je bio u skladu s onim prema ocjeni ispitivača.
English: Degenerative changes were present in the testes in rats and dogs exposed to osimertinib for ≥1 month and there was a reduction in male fertility in rats following exposure to osimertinib for 3 months.
Croatian: Degenerativne promjene bile su prisutne u testovima u štakora i pasa izloženih osimertinibu tijekom razdoblja ≥1 mjesec te je postojalo smanjenje plodnosti mužjaka štakora nakon izlaganja osimertinibu tijekom 3 mjeseca.
English: Number of patients who had first subsequent treatment or died (%)
Croatian: Broj bolesnika kojima je uvedeno prvo sljedeće liječenje ili koji su umrli (%)
English: Severe renal impairment may influence the elimination of hepatically eliminated medicinal products.
Croatian: Teško oštećenje funkcije bubrega može utjecati na eliminaciju lijekova koji se eliminiraju putem jetre.
English: Administration of osimertinib once daily results in approximately 3 fold accumulation with steady-state exposures achieved by 15 days of dosing.
Croatian: Primjena osimertiniba jedanput dnevno rezultirala je približno trostrukom akumulacijom uz postizanje izloženosti u stanju dinamičke ravnoteže nakon 15 dana doziranja.
English: The following medicines may reduce how well TAGRISSO works:
Croatian: Sljedeći lijekovi mogu smanjiti djelovanje lijeka TAGRISSO:
English: • you have severe peeling of your skin.
Croatian: • Vam se koža jako ljušti.
English: In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively.
Croatian: Medijan vremena do nastupa u ispitivanju FLAURA odnosno AURA3 bio je 19 odnosno 22 dana, dok je medijan trajanja događaja stupnja 2 iznosio 19 odnosno 6 dana.
English: Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD.
Croatian: Potrebno je provesti pomnu procjenu svih bolesnika s akutnim nastupom i/ili neobjašnjivim pogoršanjem plućnih simptoma (dispneja, kašalj, vrućica) kako bi se isključio IBP.
English: It is recommended that concomitant use of strong CYP3A inducers (e.g. Phenytoin, rifampicin and carbamazepine) with TAGRISSO should be avoided.
Croatian: Preporučuje se izbjegavati istodobnu primjenu jakih induktora CY3A4 (npr. fenitoin, rifampicin i karbamazepin) s lijekom TAGRISSO.
English: Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B).
Croatian: Na temelju kliničkih ispitivanja, nije potrebna prilagodba doze u bolesnika s blagim oštećenjem funkcije jetre (Child Pugh A) ili s umjerenim oštećenjem funkcije jetre (Child Pugh B).
English: In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities.
Croatian: U kliničkim ispitivanjima lijeka TAGRISSO, ograničen je broj bolesnika liječen dozama do 240 mg dnevno, bez toksičnosti koja ograničava dozu.
English: When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens should be determined using a validated test method (see section 4.4).
Croatian: Kada se razmatra primjena lijeka TAGRISSO, potrebno je odrediti status mutacija EGFR-a na uzorku tumora ili plazme uporabom validirane metode testiranja (vidjeti dio 4.4).
English: The median PFS was 11.0 months 95% CI (9.6, 12.4).
Croatian: Medijan PFS-a iznosio je 11,0 mjeseci (95% CI: 9,6; 12,4).
English: National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Croatian: Zajednički terminološki kriteriji za nuspojave Nacionalnog instituta za rak, verzija 4.0.
English: Also some other medicines can affect the way TAGRISSO works.
Croatian: Također, neki lijekovi mogu utjecati na način djelovanja lijeka TAGRISSO.
English: Rare (0.02%)
Croatian: Rijetko (0,02%)
English: Clinical PK interactions with CYP3A4 substrates are unlikely.
Croatian: Kliničke farmakokinetičke interakcije sa supstratima CYP3A4 nisu vjerojatne.
English: At steady-state, circulating plasma concentrations are typically maintained within a 1.6 fold range over the 24-hour dosing interval.
Croatian: U stanju dinamičke ravnoteže, cirkulirajuće koncentracije u plazmi tipično se održavaju unutar raspona od 1,6 puta tijekom intervala doziranja od 24 sata.
English: Compared with younger subjects (<65), more subjects ≥65 years old had reported adverse reactions that led to study drug dose modifications (interruptions or reductions) (13.4% versus 7.6%).
Croatian: U usporedbi s mlađim ispitanicima (u dobi <65 godina), više je ispitanika u dobi od ≥65 godina prijavilo nuspojave koje su dovele do prilagodbe doze ispitivanog lijeka (privremeni prekid ili smanjenje doze) (13,4% naspram 7,6%).
English: Subjects on the chemotherapy arm who had objective radiological progression (by the investigator and confirmed by independent central imaging review) were given the opportunity to begin treatment with TAGRISSO.
Croatian: Ispitanicima u skupini liječenoj kemoterapijom koji su doživjeli objektivnu radiološku progresiju (prema ocjeni ispitivača i potvrđenu neovisnom središnjom procjenom snimaka) ponuđena je mogućnost da započnu liječenje lijekom TAGRISSO.
English: Secondary efficacy outcome measures included Duration of Response (DoR) and Progression-Free Survival (PFS).
Croatian: Mjere sekundarnih ishoda djelotvornosti uključivale su trajanje odgovora i preživljenje bez progresije bolesti (PFS).
English: A sensitivity analysis of PFS was conducted by a Blinded Independent Central Review (BICR) and showed a median PFS of 11.0 months with TAGRISSO compared with 4.2 months with chemotherapy.
Croatian: Analiza osjetljivosti PFS-a provedena je slijepom neovisnom središnjom procjenom (BICR), te je pokazala da medijan PFS-a iznosi 11,0 mjeseci uz TAGRISSO u odnosu na 4,2 mjeseca uz kemoterapiju.
English: Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete TAGRISSO:
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO.
Croatian: Žene reproduktivne dobi treba savjetovati da izbjegavaju trudnoću tijekom liječenja lijekom TAGRISSO.
English: The model included patient, treatment, visit, treatment-by-visit interaction, baseline symptom score, and baseline symptom score-by-visit interaction and used an unstructured covariance matrix.
Croatian: Taj je model uključivao bolesnika, liječenje, posjet, liječenje s obzirom na interakciju tijekom posjete, početni rezultat za simptome s obzirom na interakciju tijekom posjete, a koristio je nestrukturiranu kovarijantnu matricu.
English: Data is cumulative from FLAURA and AURA (AURA3, AURAex, AURA 2 and AURA1) studies; only events for patients receiving at least one dose of TAGRISSO as their randomised treatment are summarised.
Croatian: Podaci su kumulativni iz ispitivanja FLAURA i AURA (AURA3, AURAex, AURA2 i AURA1); prikazani su samo događaji u bolesnika koji su primili najmanje jednu dozu lijeka TAGRISSO, koji im je dodijeljen randomizacijom.
English: Key lung cancer symptoms analysis
Croatian: Analiza ključnih simptoma raka pluća
English: This side effect is uncommon: it may affect up to 1 in 100 people.
Croatian: Ova je nuspojava manje česta: može se javiti u do 1 na 100 osoba.
English: Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Croatian: Napomena: Intenzitet kliničkih nuspojava procijenjen prema Zajedničkim terminološkim kriterijima za nuspojave (CTCAE) Nacionalnog instituta za rak, verzija 4.0.
English: These findings showed evidence of reversibility following a 1 month off-dose.
Croatian: Ovi nalazi pokazali su se reverzibilnima nakon 1 mjeseca bez doziranja.
English: If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with TAGRISSO.
Croatian: Ako se pretragom utvrdi da su u Vašem raku prisutne određene promjene (mutacije) u genu koji se zove receptor epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR) i ako se rak proširio na drugo plućno krilo ili na druge organe, vjerojatno će odgovoriti na liječenje lijekom TAGRISSO.
English: Osimertinib is a Tyrosine Kinase Inhibitor (TKI).
Croatian: Osimertinib je inhibitor tirozin kinaze.
English: If you stop taking TAGRISSO
Croatian: Ako prestanete uzimati TAGRISSO
English: In vitro, osimertinib does not inhibit OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 and MATE2K at clinically relevant concentrations.
Croatian: In vitro, osimertinib ne inhibira OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 i MATE2K pri klinički relevantnim koncentracijama.
English: Population estimated mean volume of distribution at steady-state (Vss/F) of osimertinib is 918 L indicating extensive distribution into tissue.
Croatian: Populacijski procijenjen srednji volumen distribucije u stanju dinamičke ravnoteže (Vss/F) osimertiniba je 918 l, što upućuje na opsežnu distribuciju u tkiva.
English: Based on studies in animals, female fertility may be impaired by treatment with osimertinib.
Croatian: Na temelju ispitivanja u životinja, plodnost u ženki može biti smanjena kod terapije osimertinibom.
English: Osimertinib has also been demonstrated to bind covalently to rat and human plasma proteins, human serum albumin and rat and human hepatocytes.
Croatian: Također se pokazalo da se osimertinib kovalentno veže na proteine u plazmi ljudi i štakora, ljudski serumski albumin te hepatocite štakora i ljudi.
English: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment.
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
English: Case reports of Stevens-Johnson syndrome (SJS) have been reported rarely in association with TAGRISSO treatment.
Croatian: Slučajevi Stevens-Johnsonovog sindroma (SJS), povezani s liječenjem lijekom TAGRISSO, prijavljeni su rijetko.
English: If signs and symptoms suggestive of SJS appear, TAGRISSO should be interrupted or discontinued immediately.
Croatian: Ukoliko se pojave znakovi i simptomi koji ukazuju na SJS, primjena lijeka TAGRISSO mora se odmah privremeno ili trajno prekinuti.
English: HRQL and physical functioning improvement analysis Both groups reported similar improvements in most functioning domains and global health status/HRQL, indicating that patients' overall health status improved.
Croatian: Analiza poboljšanja kvalitete života vezane uz zdravlje i tjelesne funkcije Obje su skupine prijavile slična poboljšanja u većini domena tjelesne funkcije, kao i poboljšanja općeg zdravstvenog statusa/kvalitete života vezane uz zdravlje, što ukazuje na poboljšanje cjelokupnog zdravstvenog statusa bolesnika.
English: No clinical studies have been conducted to specifically evaluate the effect of renal impairment on the pharmacokinetics of osimertinib.
Croatian: Nisu provedena klinička ispitivanja koja bi specifično ocijenila učinak oštećenja funkcije bubrega na farmakokinetiku osimertiniba.
English: Based on in vitro studies, osimertinib is a competitive inhibitor of CYP 3A4/5 but not CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 and 2E1 at clinically relevant concentrations.
Croatian: Na temelju in vitro ispitivanja, pri klinički relevantnim koncentracijama, osimertinib je kompetitivni inhibitor CYP3A4/5, ali ne i CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 i 2E1.
English: The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea (accompanied by corneal translucencies and opacities in dogs at ophthalmology examination), GI tract (including tongue), skin, and male and female reproductive tracts with secondary changes in spleen.
Croatian: Glavni nalazi opaženi u ispitivanjima toksičnosti ponovljenih doza u štakora i pasa sastojali su se od atrofičnih, upalnih i/ili degenerativnih promjena koje su zahvaćale epitel rožnice (praćeno translucencijom i zamućenjima rožnice u pasa prilikom oftalmološkog pregleda), probavni sustav (uključujući jezik), kožu te reproduktivni sustav mužjaka i ženki uz sekundarne promjene na slezeni.
English: • you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease').
Croatian: • ako ste bolovali od upalne bolesti pluća (stanje poznato kao „intersticijska bolest pluća“)
English: The geometric mean exposure of both AZ5104 and AZ7550, based on AUC, was approximately 10% each of the exposure of osimertinib at steady-state.
Croatian: Geometrijska srednja vrijednost izloženosti i za AZ5104 i za AZ7550, na temelju AUC vrijednosti, bila je približno 10% svake od izloženosti osimertiniba u stanju dinamičke ravnoteže.
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
Croatian: U bolesnika u kojih se tijekom liječenja razviju relevantni srčani znakovi/simptomi potrebno je razmotriti praćenje srčane funkcije, uključujući ocjenu LVEF-a.
English: Number of patients who had second subsequent treatment or died (%)
Croatian: Broj bolesnika kojima je uvedeno drugo sljedeće liječenje ili koji su umrli (%)
English: When considering the use of TAGRISSO as a treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation positive status is determined.
Croatian: Kada se razmatra primjena lijeka TAGRISSO za liječenje lokalno uznapredovalog ili metastatskog NSCLC-a, važno je utvrditi pozitivan status mutacije EGFR-a.
English: The primary efficacy outcome measure of these two trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR).
Croatian: Mjera primarnog ishoda djelotvornosti u ova dva ispitivanja bio je ORR prema verziji 1.1 RECIST kriterija, procijenjen u slijepoj neovisnoj središnjoj procjeni (BICR).
English: Includes cases reported within the clustered terms: Interstitial lung disease, pneumonitis.
Croatian: Uključuje slučajeve prijavljene unutar skupnog pojma: Intersticijska bolest pluća, pneumonitis.
English: When osimertinib was administered to pregnant female rats throughout gestation and then through early lactation, there was demonstrable exposure to osimertinib and its metabolites in suckling pups plus a reduction in pup survival and poor pup growth (at doses of 20 mg/kg and above).
Croatian: Kada se osimertinib primjenjivao gravidnim ženkama štakora tijekom gestacije i zatim tijekom rane laktacije, postojala je dokaziva izloženost osimertinibu i njegovim metabolitima u mladunčadi koja sisa uz smanjeno preživljenje i usporen rast mladunčadi (pri dozama od 20 mg/kg i višima).
English: If you forget to take TAGRISSO
Croatian: Ako ste zaboravili uzeti TAGRISSO
English: Cartons of 30 x 1 tablets (3 blisters).
Croatian: Kutije od 30 x 1 tableta (3 blistera).