natgillin/translations-raw huggingface dataset:
The QTc interval prolongation potential of TAGRISSO was assessed in 210 patients who received osimertinib 80 mg daily in AURA2.
Potencial zdravila TAGRISSO za podaljšanje intervala QTc so ocenili pri 210 bolnikih, ki so prejemali 80 mg osimertiniba na dan v študiji AURA2.
If administration via nasogastric tube is required, the same process as above should be followed but using volumes of 15 mL for the initial dispersion and 15 mL for the residue rinses.
Če je potrebna uporaba po nazogastrični sondi, je treba upoštevati zgoraj opisani postopek, vendar je treba za začetno disperzijo uporabiti 15 ml in za izpiranje ostanka 15 ml tekočine.
Dose reduction guidelines for adverse reactions toxicities are provided in Table 1.
Smernice za zmanjšanje odmerka v primeru neželenih učinkov/toksičnosti so navedene v preglednici 1.
• If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice.
• Če načrtujete nosečnost po zadnjem odmerku tega zdravila, za nasvet prosite zdravnika.
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).
Na podlagi kliničnih študij prilagajanje odmerka ni potrebno pri bolnikih z blago okvaro jeter (Child-Pugh A) ali z zmerno okvaro jeter (Child-Pugh B).
30 x 1 film-coated tablets 28 x 1 film-coated tablets
30 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta
• Digoxin - used for irregular heart beat or other heart problems.
• digoksin - uporablja se za zdravljenje neenakomernega srčnega utripa ali drugih bolezni srca.
• TAGRISSO may interfere with how well oral hormonal contraceptives work.
• Zdravilo TAGRISSO lahko ovira delovanje peroralnih hormonskih kontraceptivov.
This medicinal product is for oral use.
To zdravilo je namenjeno za peroralno uporabo.
Clinical PK interactions with CYP3A4 substrates are unlikely.
Klinično farmakokinetično medsebojno delovanje s substrati CYP3A4 ni verjetno.
You must also do this after completing treatment with TAGRISSO:
Kontracepcijo morate uporabljati tudi po končanem zdravljenju z zdravilom TAGRISSO:
Microcrystalline cellulose Low-substituted hydroxypropyl cellulose Sodium stearyl fumarate
Jedro tablete manitol mikrokristalna celuloza nizkosubstituirana hidroksipropilceluloza natrijev stearilfumarat
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%).
V primerjavi z mlajšimi bolniki (< 65 let) je več bolnikov v starosti ≥ 65 let poročalo neželene učinke, ki so zahtevali prilagoditve odmerka raziskovanega zdravila (prekinitve ali zmanjšanja) (13,4 % v primerjavi s 7,6 %).
Pulmonary ILD/Pneumonitis
Pljučni IBP/pnevmonitis
Patients in the TAGRISSO arm received TAGRISSO 80 mg orally once daily until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Bolniki v skupini z zdravilom TAGRISSO so prejemali 80 mg zdravila TAGRISSO peroralno enkrat na dan, dokler se ni pojavilo neprenašanje zdravljenja ali dokler raziskovalec ni ugotovil, da zdravljenje bolniku klinično ne koristi več.
QTc interval prolongation with signs/symptoms of serious arrhythmia
Podaljšanje intervala QTc z znaki/simptomi resnih motenj srčnega ritma
If signs and symptoms suggestive of SJS appear, TAGRISSO should be interrupted or discontinued immediately.
Če se pojavijo znaki ali simptomi, ki nakazujejo SJS, je treba zdravljenje z zdravilom TAGRISSO nemudoma prekiniti ali končati.
Also some other medicines can affect the way TAGRISSO works.
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila TAGRISSO.
It is recommended that concomitant use of strong CYP3A inducers (e.g. Phenytoin, rifampicin and carbamazepine) with TAGRISSO should be avoided.
Sočasni uporabi močnih induktorjev CYP3A (npr. fenitoina, rifampicina, karbamazepina) in zdravila TAGRISSO se je priporočljivo izogniti.
Carcinogenicity studies have not been performed with osimertinib.
Študij kancerogenosti z osimertinibom niso izvedli.
Forty-seven percent (47%) of patients had metastatic bone disease.
Sedeminštirideset odstotkov (47 %) bolnikov je imelo metastatsko bolezen kosti.
Based on a pharmacokinetic analysis of 134 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 1216 patients with normal hepatic function osimertinib exposures were similar.
Na podlagi farmakokinetične analize 134 bolnikov z blago okvaro jeter, 8 bolnikov z zmerno okvaro jeter in 1216 bolnikov z normalnim delovanjem jeter je bila izpostavljenost osimertinibu podobna.
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.
Analiza izboljšanja z zdravjem povezane kakovosti življenja in telesnega delovanja Obe skupini sta poročali o podobnem izboljšanju na večini funkcijskih področij in v splošnem zdravstvenem stanju/z zdravjem povezani kakovosti življenja; to kaže, da se je celotno zdravstveno stanje bolnikov izboljšalo.
QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Takšno podaljšanje lahko poveča tveganje za ventrikularne tahiaritmije (npr. torsade de pointes) ali nenadno smrt.
Based on population PK analysis, there was no relationship between markers of hepatic function (ALT, AST, bilirubin) and osimertinib exposure.
Na podlagi populacijske farmakokinetične analize ni povezave med označevalci delovanja jeter (ALT, AST, bilirubin) in izpostavljenostjo osimertinibu.
Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval.
O rednih kontrolah elektrokardiograma (EKG) in elektrolitov je treba razmisliti pri bolnikih s kongestivnim srčnim popuščanjem, elektrolitskimi motnjami in prejemnikih zdravil, za katera je znano, da podaljšajo interval QTc.
There are no or limited amount of data from the use of osimertinib in pregnant women.
Podatkov o uporabi osimertiniba pri nosečnicah je malo ali jih sploh ni.
A CNS ORR of 54% (27/50 patients; 95% CI: 39.3, 68.2) was observed with 12% of these responses being complete responses.
ORR v CNS je bil 54 % (27/50 bolnikov, 95 % IZ: 39,3; 68,2) in 12 % teh odzivov je bilo popolnih odzivov.
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).
Tako zavre rast celic, bistveno manj pa deluje proti EGFR v celičnih linijah divjega tipa (navidezne IC50 proti fosfo-EGFR od 480 nM do 1,8 µM).
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.
Degenerativne spremembe so se pojavile v modih podgan in psov, izpostavljenih osimertinibu ≥ 1 mesec, in pri podganah se je plodnost samcev zmanjšala po 3-mesečni izpostavljenosti osimertinibu.
There is limited experience with accidental overdoses in humans.
Izkušenj z naključnim prevelikim odmerjanjem pri človeku je malo.
What you need to know before you take TAGRISSO
Kaj morate vedeti, preden boste vzeli zdravilo TAGRISSO
Patient tumour tissue samples were required to have one of the two common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), as identified by local or central testing.
Vzorci bolnikovega tumorskega tkiva so morali imeti eno od dveh pogostih mutacij EGFR, za kateri je znano, da sta povezani z občutljivostjo za EGFR TKI (Ex19del ali L858R); kar je bilo ugotovljeno z lokalnim ali centralnim testiranjem.
• Stevens-Johnson syndrome, which can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms.
• Stevens-Johnsonov sindrom, ki se lahko pojavi kot rdečkaste, tarčam podobne pege ali okrogle lise, pogosto s centralnimi mehurji na trupu, luščenjem kože, razjedami v ustih, žrelu, nosu, na spolovilih in očeh; pred tem se lahko pojavijo zvišana telesna temperatura in gripi podobni simptomi.
Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies.
Zdravljenje z zdravilom TAGRISSO mora uvesti zdravnik, ki ima izkušnje z zdravili za zdravljenje raka.
In the 411 pre-treated EGFR T790M mutation-positive patients, the total ORR by Blinded Independent Central Review (BICR) was 66% (95% CI: 61, 71).
Pri 411 predhodno zdravljenih bolnikih s pozitivno mutacijo EGFR T790M je bil ORR po slepljenem neodvisnem centralnem pregledu (BICR) 66 % (95 % IZ: 61; 71).
Grade 3 and Grade 4 adverse reactions across both studies were 9.7% and 0.9%, respectively.
V obeh študijah skupaj je bilo neželenih učinkov 3. stopnje 9,7 % in 4. stopnje 0,9 %.
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.
Trajno ukinite zdravljenje z osimertanibom, če se bolniku pojavi podaljšanje intervala QTc v kombinaciji s čimer koli od naslednjega: torsade de pointes, polimorfna ventrikularna tahikardija, znaki/simptomi resne motnje srčnega ritma.
Results from animal studies have shown that osimertinib has effects on male and female reproductive organs and could impair fertility (see section 5.3).
Rezultati študij na živalih so pokazali, da osimertinib vpliva na reproduktivne organe samcev in samic in lahko okvari plodnost (glejte poglavje 5.3).
TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.'
Zdravilo TAGRISSO uporabljamo za zdravljenje odraslih z vrsto pljučnega raka, imenovanega “nedrobnocelični rak pljuč”.
It is not known whether osimertinib or its metabolites are excreted in human milk.
Ni znano, ali se osimertinib ali njegovi presnovki pri človeku izločajo v materino mleko.
The LC13 was initially administered once a week for the first 6 weeks, then every 3 weeks before and after progression.
LC13 so uvodoma uporabljali enkrat na teden prvih 6 tednov in nato vsake tri tedne pred napredovanjem in po njem.
Pregnancy - information for men
Nosečnost - informacije za moške
Pathology findings in the testes seen following 1 month dosing were reversible in rats; however, a definitive statement on reversibility of these lesions in dogs cannot be made.
Patološke spremembe v modih, ugotovljene po 1 mesecu uporabe, so bile pri podganah reverzibilne, dokončne ugotovitve o reverzibilnosti teh sprememb pri psih pa ni mogoče podati.
There are no clinical data available to recommend a dose adjustment of TAGRISSO.
Kliničnih podatkov, ki bi omogočali priporočilo za prilagoditev odmerka zdravila TAGRISSO, ni na voljo.
Changes in cardiac contractility
Spremembe v krčljivosti srca
TAGRISSO has not been studied in children or adolescents.
Zdravilo TAGRISSO pri otrocih in mladostnikih ni raziskano.
Moderate CYP3A4 inducers (e.g. bosentan, efavirenz, etravirine, modafinil) may also decrease osimertinib exposure and should be used with caution, or avoided when possible.
Izpostavljenost osimertinibu lahko zmanjšajo tudi zmerni induktorji CYP3A4 (npr. bosentan, efavirenz, etravirin, modafinil), zato jih je treba uporabljati previdno oziroma se jim je treba izogniti, če je mogoče.
Taking the extremes of body weight into consideration, from <43 kg to >88 kg, AZ5104 metabolite ratios ranged from 11.8% to 9.6% while for AZ7550 it ranged from 12.8% to 8.1%, respectively.
Upoštevaje skrajne vrednosti telesne mase od < 43 do > 88 kg so bila razmerja presnovka AZ5104 v razponu od 11,8 % do 9,6 %, presnovka AZ7550 pa med 12,8 % in 8,1 %.
The absolute bioavailability of TAGRISSO is 70% (90% CI 67, 73).
Absolutna biološka uporabnost zdravila TAGRISSO je 70 % (90 % IZ: 67 do 73).
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.
Glavni izsledki v študijah toksičnosti ponavljajočih se odmerkov pri podganah in psih so obsegali atrofične, vnetne in/ali degenerativne spremembe, ki so prizadele epitelije roženice (ob sočasnih roženičnih translucencah in motnostih pri psih na oftalmološkem pregledu), prebavil (vključno z jezikom), kože ter moških in ženskih reproduktivnih organov ter sekundarne spremembe v vranici.
Includes cases reported within the clustered terms: Interstitial lung disease, pneumonitis.
Združuje primere, poročane z izrazoma: intersticijska bolezen pljuč, pnevmonitis.
Studies in animals have shown reproductive toxicity (embryolethality, reduced foetal growth, and neonatal death, see section 5.3).
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja (smrt zarodka, zmanjšana rast ploda in smrt novorojenčka, glejte poglavje 5.3).
Based on in vitro data, osimertinib is an inhibitor of BCRP and P-gp (see section 4.5).
Na podlagi podatkov in vitro je osimertinib zaviralec BCRP in P-gp (glejte poglavje 4.5).
Gastric pH modifying agents can be concomitantly used with TAGRISSO without any restrictions.
Zdravila, ki spreminjajo želodčni pH, je mogoče uporabljati sočasno z zdravilom TAGRISSO brez omejitev.
Other side effects Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer.
Zdravilo TAGRISSO vsebuje učinkovino osimertinib; ta spada v skupino zdravil, imenovanih zaviralci protein-kinaze, ki se uporabljajo za zdravljenje raka.
Adverse reactions have been assigned to the frequency categories in Table 2 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the 1142 EGFR mutation positive NSCLC patients who received TAGRISSO at a dose of 80 mg daily in the FLAURA, AURA3, AURAex, AURA 2 and AURA1 studies.
Neželeni učinki v preglednici 2 so razvrščeni po kategorijah pogostnosti, kjer je bilo mogoče, na podlagi incidence primerljivih poročil o neželenih učinkih v združeni analizi podatkov 1142 bolnikov z NSCLC in pozitivno mutacijo EGFR, ki so prejemali zdravilo TAGRISSO v odmerku 80 mg na dan v študijah FLAURA, AURA3, AURAex, AURA2 in AURA1.
Findings in the ovaries seen following 1 month dosing were reversible.
Spremembe, opažene na jajčnikih po 1-mesečni uporabi, so bile reverzibilne.
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.
Po enkratnem peroralnem odmerku 20 mg se je 67,8 % odmerka pojavilo v blatu (1,2 % kot matična spojina), 14,2 % uporabljenega odmerka (0,8 % kot matična spojina) pa v urinu do 84. dne zbiranja.
4.4 Special warnings and precautionsfor use
4.4 Posebna opozorila in previdnostni ukrepi
• Stomatitis - inflammation of the inner lining of the mouth.
• Stomatitis - vnetje sluznice ust.
A BICR assessment of these scans resulted in a subgroup of 128/556 (23%) patients with CNS metastases and these data are summarised in Table 4.
Na podlagi ocene BICR (Blinded Independent Central Review) teh posnetkov je bila oblikovana podskupina 128/556 (23 %) bolnikov z metastazami v CNS; ti podatki so povzeti v preglednici 4.
In patients treated with TAGRISSO 80 mg once daily, dose reductions due to adverse reactions occurred in 2.1% of the patients.
Med bolniki, ki so prejemali zdravilo TAGRISSO 80 mg enkrat na dan, so zaradi neželenih učinkov odmerek zmanjšali 2,1 % bolnikom.
Yellow iron oxide (E 172) Red iron oxide (E 172) Black iron oxide (E 172)
Obloga tablete polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec rumeni železov oksid (E 172) rdeči železov oksid (E 172) črni železov oksid (E 172)
• TAGRISSO may pass into semen.
• Zdravilo TAGRISSO lahko prehaja v spermo.
Patients were evaluated for LVEF at screening and every 12 weeks thereafter.
LVEF so pri bolnikih ocenili ob presejanju in so ga nato ocenjevali na 12 tednov.
10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED)
10 FILMSKO OBLOŽENIH TABLET V PRETISNEM OMOTU (PERFORIRANI) 7 FILMSKO OBLOŽENIH TABLET V PRETISNEM OMOTU (PERFORIRANI)
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati to zdravilo.
Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Opomba: Izrazitost kliničnih neželenih učinkov je ocenjena po Terminološko poenotenih kriterijih za neželene dogodke (CTCAE - Common Terminology Criteria for Adverse Events) ameriškega Nacionalnega inštituta za raka (NCI - National Cancer Institute), verzija 4.0.
Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy.
Analiza opazovanih dogodkov po napredovanju je pokazala, da se je korist za preživetje brez napredovanja bolezni ohranila med nadaljnjimi linijami zdravljenja.
Strong CYP3A4 inducers can decrease the exposure of osimertinib.
Močni induktorji CYP3A lahko zmanjšajo izpostavljenost osimertinibu.
Keratitis was reported in 0.7% (n=8) of the 1142 patients treated with TAGRISSO in the FLAURA and AURA studies.
O keratitisu so poročali pri 0,7 % (n = 8) od 1142 bolnikov, zdravljenih z zdravilom TAGRISSO v študijah FLAURA in AURA.
A pharmacokinetic study in patients with renal impairment has not been conducted.
Farmakokinetične študije pri bolnikih z okvaro ledvic niso izvedli.
• Aliskiren-used for high blood pressure.
• aliskiren - uporablja se za zdravljenje visokega krvnega tlaka.
The hepatic impairment marker serum albumin showed an effect on the PK of osimertinib.
Označevalec okvare jeter serumski albumin je pokazal vpliv na farmakokinetiko osimertiniba.
Therefore, CYP3A4 inhibitors are not likely to affect the exposure of osimertinib.
Zato ni verjetno, da bi zaviralci CYP3A4 vplivali na izpostavljenost osimertinibu.
At steady-state, circulating plasma concentrations are typically maintained within a 1.6 fold range over the 24-hour dosing interval.
V stanju dinamičnega ravnovesja se koncentracija v krožeči plazmi v 24-urnem odmernem intervalu praviloma ohrani znotraj 1,6-kratnega območja.
• Dabigatran - used to prevent blood clots.
• dabigatran - uporablja se za preprečevanje krvnih strdkov.
Population estimated mean volume of distribution at steady-state (Vss/F) of osimertinib is 918 L indicating extensive distribution into tissue.
Populacijsko ocenjen povprečni volumen porazdelitve osimertiniba v stanju dinamičnega ravnovesja (Vss/F) je 918 l; to kaže na obsežno porazdelitev v tkiva.
See also Section 2.
Glejte tudi poglavje 2.
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.
Analiza senzitivnosti PFS, opravljena s slepljenim neodvisnim centralnim pregledom (BICR - Blinded Independent Central Review), je pokazala mediano vrednost PFS 11,0 mesecev z zdravilom TAGRISSO in 4,2 meseca s kemoterapijo.
A consistent pattern in safety and efficacy results was observed in the analysis of AURA Phase 2 studies.
V analizi študij AURA 2. faze so opažali skladnost rezultatov o varnosti in učinkovitosti.
National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Terminološko poenoteni kriteriji za neželene učinke ameriškega Nacionalnega inštituta za raka (National Cancer Institute Common Terminology Criteria for Adverse Events), verzija 4.0.
The median duration of follow up for PFS was 12.6 months.
Spremljanje glede preživetja brez napredovanja bolezni je mediano trajalo 12,6 meseca.
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.
Na podlagi študij in vitro osimertinib v klinično pomembnih koncentracijah kompetitivno zavira CYP 3A4/5, ne pa CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 in 2E1.
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).
Ko so osimertinib uporabili pri brejih podganah med gestacijo in nato med zgodnjim obdobjem dojenja, so dokazali izpostavljenost dojenih mladičev osimertinibu in njegovim presnovkom ter zmanjšano preživetje mladičev in njihovo slabo rast (ob odmerkih 20 mg/kg ali več).
Driving and using machines TAGRISSO has no or no marked influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo TAGRISSO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Patient-reported symptoms and health-related quality of life (HRQL) were electronically collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Izidi po navedbi bolnikov (PRO - patient reported outcomes) Simptomi po navedbi bolnikov in z zdravjem povezana kakovost življenja so bili evidentirani elektronsko z uporabo EORTC QLQ-C30 in njegovega modula za raka pljuč (EORTC QLQ-LC13).
There is no specific treatment in the event of TAGRISSO overdose.
Specifičnega zdravljenja za preveliko odmerjanje zdravila TAGRISSO ni.
Patients were randomised 1:1 to receive either TAGRISSO (n=279, 80 mg orally once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg orally once daily or erlotinib 150 mg orally once daily).
Bolnike so v razmerju 1:1 randomizirali na prejemanje zdravila TAGRISSO (n = 279, 80 mg peroralno enkrat na dan) ali primerjalnega EGFR TKI (n = 277, gefitinib 250 mg peroralno enkrat na dan ali erlotinib 150 mg peroralno enkrat na dan).
St. John's Wort should not be used together with TAGRISSO (see section 4.5).
Šentjanževke se ne sme uporabljati skupaj z zdravilom TAGRISSO (glejte poglavje 4.5).
Based on a clinical pharmacokinetic study in patients at 80 mg, food does not alter osimertinib bioavailability to a clinically meaningful extent.
Na podlagi klinične farmakokinetične študije pri bolnikih z odmerkom 80 mg hrana ne vpliva na biološko uporabnost osimertiniba v klinično pomembni meri.
In a modified embryofoetal development study in the rat, osimertinib caused embryolethality when administered to pregnant rats prior to embryonic implantation.
V prilagojeni študiji embriofetalnega razvoja pri podganah je osimertinib povzročil smrt zarodkov, če so ga uporabili pri brejih podganah pred implantacijo zarodkov.
In the FLAURA and AURA studies, diarrhoea was reported in 49% of patients of which 39% were Grade 1 events, 8.0% Grade 2 and 1.2% were Grade 3; no Grade 4 or 5 events were reported.
V študijah FLAURA in AURA so o driski poročali pri 49 % bolnikov: 39 % primerov je bilo 1. stopnje, 8,0 % 2. stopnje in 1,2 % 3. stopnje; o driski 4. ali 5. stopnje niso poročali.