FrancophonIA/ELRC3.0 huggingface dataset:
English: Doravirine demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.
Slovenian: Vrednost EC50 (50 % maksimalne efektivne koncentracije) doravirina proti divjemu tipu laboratorijskih sevov HIV-1, testirana v prisotnosti 100 % normalnega človeškega seruma z uporabo poročevalskih celic MT4-GFP, je bila 12,0 ± 4,4 nM. Doravirin je izkazal protivirusno aktivnost proti obsežni skupini primarnih izolatov HIV-1 (A, A1, AE, AG, B, BF, C, D, G, H) z vrednostjo EC50 od 1,2 do 10,0 nM.
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Slovenian: Občasni konstipacija, nelagodje v trebuhu 5, napetost trebuha, dispepsija, mehko blato 6, motnja gastrointestinalne motilitete
English: 20-200 mg QD individualised dose, doravirine 100 mg QD
Slovenian: 20-200 mg 1x/dan individualiziran odmerek, doravirin 100 mg 1x/dan
English: DRV + r + NRTIs*
Slovenian: DRV + r + 2 NRTI
English:  doravirine AUC 1.15 (1.07, 1.24) Cmax 1.11 (0.97, 1.27) C24 1.24 (1.13, 1.36)
Slovenian:  doravirin AUC 1,15 (1,07; 1,24) Cmax 1,11 (0,97; 1,27) C24 1,24 (1,13; 1,36)
English: • 1 bottle with 30 film-coated tablets.
Slovenian: • 1 plastenka s 30 filmsko obloženimi tabletami,
English: Doravirine 25 mg
Slovenian: Doravirin 25 mg
English: • kidney damage, kidney problems, kidney stones
Slovenian: • okvara ledvic, težave z ledvicami, ledvični kamni
English: When doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Slovenian: Če je doravirin uporabljen sočasno z rifabutinom, je treba odmerek doravirina povečati na 100 mg dvakrat na dan (te odmerke je treba vzeti v presledku približno 12 ur) (glejte poglavje 4.2).
English: • tacrolimus (a medicine used to control your body's immune response after a transplant)
Slovenian: • takrolimus (zdravilo za obvladovanje telesnega imunskega odziva po presaditvi).
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets).
Slovenian: • 90 filmsko obloženih tablet (3 plastenke po 30 filmsko obloženih tablet).
English: Expected: ↔ doravirine ↔ enfuviritide maraviroc
Slovenian: Pričakovano: ↔ doravirin ↔ enfuvirtid maravirok
English:  doravirine AUC 3.54 (3.04, 4.11) Cmax 1.31 (1.17, 1.46) C24 2.91 (2.33, 3.62) (Inhibition of CYP3A)
Slovenian:  doravirin AUC 3,54 (3,04; 4,11) Cmax 1,31 (1,17; 1,46) C24 2,91 (2,33; 3,62) (zavrtje CYP3A)
English: What Pifeltro contains
Slovenian: Kaj vsebuje zdravilo Pifeltro
English: Mutagenesis Doravirine was not genotoxic in a battery of in vitro or in vivo assays.
Slovenian: Doravirin v skupini preizkusov in vitro in in vivo ni bil genotoksičen.
English: What Pifeltro is used for
Slovenian: Za kaj uporabljamo zdravilo Pifeltro
English: Recommendation Concerning Co-administration with doravirine
Slovenian: Priporočilo glede sočasne uporabe z doravirinom
English: Doravirine 200 mg
Slovenian: Doravirin 200 mg
English:  dolutegravir AUC 1.36 (1.15, 1.62) Cmax 1.43 (1.20, 1.71) C24 1.27 (1.06, 1.53) (Inhibition of BCRP)
Slovenian:  dolutegravir AUC 1,36 (1,15; 1,62) Cmax 1,43 (1,20; 1,71) C24 1,27 (1,06; 1,53) (zavrtje BCRP)
English: Gastrointestinal disorders Common nausea, diarrhoea, flatulence, abdominal pain vomiting
Slovenian: Bolezni prebavil Pogosti navzea, diareja, napenjanje, bolečine v trebuhu bruhanje
English: Doravirine 50 mg
Slovenian: Doravirin 50 mg
English: Co-administration of doravirine and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Slovenian: Sočasna uporaba doravirina in zdravil, ki zavirajo CYP3A, lahko poveča koncentracijo doravirina v plazmi, vendar pa med sočasno uporabo z zaviralci CYP3A odmerka doravirina ni treba prilagoditi.
English: Doravirine 100 mg
Slovenian: Doravirin 100 mg
English: • constipation, stomach discomfort, swollen or bloated stomach (abdominal distension),
Slovenian: • zaprtost, nelagodje v trebuhu, otekel ali napihnjen trebuh, težave z želodcem, mehko blato, krči v trebuhu
English: Interactions table
Slovenian: Preglednica medsebojnih delovanj
English: What Pifeltro is
Slovenian: Kaj je zdravilo Pifeltro
English: Nucleoside Reverse Transcriptase Inhibitors tenofovir disoproxil (245 mg QD, doravirine 100 mg SD)
Slovenian: Nukleozidni zaviralci reverzne transkriptaze dizoproksiltenofovirat (245 mg 1x/dan, doravirin 100 mg enkratni odmerek)
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1 infected subjects.
Slovenian: Na podlagi populacijske farmakokinetične analize doravirina pri zdravih osebah in preiskovancih, okuženih s HIV-1, niso ugotovili klinično pomembnih rasnih razlik v farmakokinetiki doravirina.
English: Expected: ↔ doravirine ↔ emtricitabine tenofovir alafenamide
Slovenian: Pričakovano: ↔ doravirin ↔ emtricitabin tenofoviralafenamid
English: Doravirine has not been studied in patients with end-stage renal disease and has not been studied in dialysis patients (see section 5.2).
Slovenian: Doravirin ni raziskan pri bolnikih s končno odpovedjo ledvic in pri bolnikih na dializi (glejte poglavje 5.2).
English: Renal and urinary disorders Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis General disorders and administration site conditions Common fatigue
Slovenian: Bolezni sečil Redki akutna okvara ledvic, ledvična motnja, kamen v sečilih, nefrolitiaza Splošne težave in spremembe na mestu aplikacije Pogosti utrujenost
English: Pharmacokinetic Enhancers ritonavir (100 mg BID, doravirine 50 mg SD)
Slovenian: Farmakokinetični ojačevalci ritonavir (100 mg 2x/dan, doravirin 50 mg enkratni odmerek)
English:  lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
Slovenian:  lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
English: Mean CD4 change from baseline
Slovenian: Povprečna sprememba CD4 od izhodišča študija DRIVE-FORWARD
English: Expected:  doravirine daclatasvir
Slovenian: Pričakovano:  doravirin daklatasvir
English: Expected: ↔ doravirine ↔ abacavir
Slovenian: Pričakovano: ↔ doravirin ↔ abakavir emtricitabin
English: B.
Slovenian: V II.
English:  doravirine AUC 1.00 (0.89, 1.12) Cmax 1.06 (0.88, 1.28) C24 0.98 (0.88, 1.09)
Slovenian:  doravirin AUC 1,00 (0,89; 1,12) Cmax 1,06 (0,88; 1,28) C24 0,98 (0,88; 1,09)
English: If you get any side effects, talk to your doctor,pharmacist, or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: It is not known whether the exposure to doravirine will increase in patients with severe hepatic impairment.
Slovenian: Ni znano, ali se izpostavljenost doravirinu pri bolnikih s hudo okvaro jeter poveča, zato je v primeru uporabe doravirina pri bolnikih s hudo okvaro jeter potrebna previdnost (glejte poglavje 5.2).
English: Musculoskeletal and connective tissue disorders Uncommon myalgia, arthralgia
Slovenian: Redki alergijski dermatitis, rozacea Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni mialgija, artralgija
English:  doravirine AUC 0.74 (0.61, 0.90) Cmax 0.76 (0.63, 0.91) C24 0.80 (0.63, 1.03)
Slovenian:  doravirin AUC 0,74 (0,61; 0,90) Cmax 0,76 (0,63; 0,91) C24 0,80 (0,63; 1,03)
English: Expected:  doravirine (Inhibition of CYP3A4)
Slovenian: Pričakovano:  doravirin (zavrtje CYP3A4)
English: • muscle pain, joint pain
Slovenian: • bolečina v mišicah, bolečina v sklepih
English: ↔ elvitegravir cobicistat-boosted elvitegravir
Slovenian: ↔ elvitegravir s kobicistatom ojačeni elvitegravir
English: Skin and subcutaneous tissue disorders Common rash
Slovenian: Bolezni kože in podkožja Pogosti izpuščaj
English: Expected: ↔ buprenorphine ↔ naloxone
Slovenian: Pričakovano: ↔ buprenorfin ↔ nalokson
English: Integrase Strand Transfer Inhibitors dolutegravir (50 mg QD, doravirine 200 mg QD)
Slovenian: Zaviralci prenosa zapisa integraze dolutegravir (50 mg 1x/dan, doravirin 200 mg 1x/dan)
English: After week 24, all subjects randomized to receive doravirine were switched to (or maintained on) doravirine 100 mg. Additional subjects were randomized in Part II to receive either doravirine 100 mg or EFV, each in combination with FTC/TDF.
Slovenian: Po 24. tednu so vsi preiskovanci, ki so bili randomizirani na prejemanje doravirina, prešli na (ali so še naprej uporabljali) 100 mg doravirina.
English: No dose adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic odmerka doravirina ni treba prilagoditi.
English: There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats up to 7 times the exposure in humans at the RHD.
Slovenian: Med uporabo doravirina pri podganah v izpostavljenostih, ki so bile do 7-krat večje kot je izpostavljenost pri človeku med uporabo RHD, niso ugotovili vplivov na plodnost, sposobnost za parjenje ali zgodnji razvoj zarodka.
English: Protease Inhibitors ritonavir
Slovenian: ↔ ojačeni zaviralci proteaz
English: cobicistat
Slovenian: kobicistat
English: Expected: ↓ doravirine (Induction of CYP3A)
Slovenian: Pričakovano: ↓doravirin (indukcija CYP3A)
English: Expected: ↓doravirine (Induction of CYP3A)
Slovenian: Pričakovano: ↓ doravirin (indukcija CYP3A)
English: Baseline CD4 cell count was carried forward for subjects who discontinued assigned therapy due to lack of efficacy.
Slovenian: Obravnavanje manjkajočih podatkov: Metoda opaženega neuspeha: pri preiskovancih, ki so dodeljeno zdravljenje prenehali uporabljati zaradi izostanka učinkovitosti, je bil uporabljen prenos izhodiščnega števila celic CD4.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: †- boosted PIs (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
Slovenian: Zaviralci proteaz z ritonavirjem† ojačeni zaviralci proteaz (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, sakvinavir, tipranavir)
English: 50 to < 65
Slovenian: od 50 do < 65
English: Median (IQR), months
Slovenian: mediana (IQR), meseci
English: The effect of food
Slovenian: Učinek hrane
English: Tell your doctor straight away if you notice any of the following symptoms which could be a sign of serious blood disorder:
Slovenian: Takoj obvestite zdravnika, če opazite kateregakoli izmed naslednjih simptomov, ki so lahko znak resne bolezni krvi:
English: Overall survival (interim analysis)c
Slovenian: Celokupno preživetje (vmesna analiza)
English: 90537 Feucht Germany
Slovenian: 90537 Feucht Nemčija
English: The OS interim analysis was performed at 51% for the total number of planned events.
Slovenian: Vmesno analizo OS so opravili pri 51 % skupnega števila načrtovanih dogodkov.
English: Minimum, maximum
Slovenian: mediana najmanj, največ
English: You can take Talzenna with food or between meals.
Slovenian: Zdravilo Talzenna lahko vzamete s hrano ali med obroki.
English: Frequency categories are defined as: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Slovenian: Pogostnosti so opredeljene na naslednji način: zelo pogosti (≥ 1/10) in pogosti (≥ 1/100 do < 1/10).
English: Take the carton and this leaflet so that the doctor knows what you have been taking.
Slovenian: S seboj vzemite škatlo in to navodilo za uporabo, da bo zdravnik vedel, kaj ste vzeli.
English: To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved.
Slovenian: Da ne pride do stika z vsebino kapsule, moramo kapsulo pogoltniti celo in je ne smemo odpirati ali raztapljati.
English: The median duration of exposure was 5.4 months (range 0.03-61.1).
Slovenian: Mediano trajanje izpostavljenosti je bilo 5,4 meseca (razpon 0,03-61,1).
English: Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.
Slovenian: Zdravilo Talzenna uporabljamo, kadar se rak razširi zunaj prvotnega tumorja ali v druge dele telesa.
English: Most of the histopathologic findings were generally reversible while the testes findings were partially reversible after 4 weeks of dosing cessation.
Slovenian: Večina histopatoloških sprememb je bila na splošno reverzibilnih, spremembe na testisih pa so bile delno reverzibilne po 4 tednih prekinitve odmerjanja.
English: Recommended dose reductions are indicated in Table 1.
Slovenian: Priporočena zmanjšanja odmerka so navedena v preglednici 1.
English: Age, sex, and body weight
Slovenian: Starost, spol in telesna masa
English: Food intake decreased the rate but not the extent of talazoparib absorption.
Slovenian: Vnos hrane je zmanjšal hitrost, ne pa obsega absorpcije talazopariba.
English: g. For talazoparib Grade 1 is 21% and Grade 2 is 2%.
Slovenian: Delež stopnje 1 pri talazoparibu je 21 %, delež stopnje 2 pa 2 %.
English: However, based on urinary excretion data the absolute bioavailability is at least 41% with fraction absorbed of at least 69% (see Elimination).
Slovenian: Vendar je na podlagi podatkov o izločanju z urinom absolutna biološka uporabnost vsaj 41 %, pri čemer je faktor absorpcije najmanj 69 % (glejte Izločanje).
English: If you feel dizzy, weak, or tired (these are very common side effects of Talzenna), you should not drive or use machines.
Slovenian: Če ste omotični, oslabeli ali utrujeni (to so zelo pogosti neželeni učinki zdravila Talzenna), ne smete upravljati vozil ali strojev.
English: Co-administration should only be considered after careful evaluation of the potential benefits and risks.
Slovenian: Sočasna uporaba pride v poštev šele po skrbni oceni morebitnih koristi in tveganj.
English: Talzenna could harm an unborn baby.
Slovenian: Zdravilo Talzenna lahko škoduje nerojenemu otroku.
English: The absolute bioavailability study has not been conducted in humans.
Slovenian: Študije absolutne biološke uporabnosti pri ljudeh niso izvedli.
English: Do not take a double dose to make up for the forgotten or vomited capsules.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno ali izbruhano kapsulo.
English: Symptoms of overdose are not established.
Slovenian: Simptomov prevelikega odmerjanja niso ugotovili.
English: No prior treatment with a PARP inhibitor was permitted.
Slovenian: Predhodno zdravljenje z zaviralcem PARP ni bilo dovoljeno.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če je ovojnina poškodovana ali kaže znake odpiranja.
English: The secondary objectives were objective response rate (ORR), overall survival (OS), safety, and PK.
Slovenian: Sekundarni cilji so bili objektivni odziv na zdravljenje (ORR - objective response rate), celokupno preživetje (OS - overall survival), varnost in FK.
English: Please see section “Male and female contraception” below.
Slovenian: Glejte spodnje poglavje ''Kontracepcija pri moških in ženskah''.
English: If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakršnakoli vprašanja o tem, kako deluje zdravilo Talzenna ali zakaj so vam predpisali to zdravilo, se posvetujte z zdravnikom.
English: As a result, the cancer cells can no longer repair themselves and they die.
Slovenian: Posledica tega je, da se rakave celice ne morejo več popravljati, zato odmrejo.
English: If you stop taking Talzenna Do not stop taking Talzenna unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Talzenna Zdravila Talzenna ne prenehajte jemati, razen če vam tega ne naroči zdravnik.
English: Abbreviations: n=number of patients; N/A=not applicable.
Slovenian: Okrajšave: n = število bolnikov; N/A = navedba smiselno ni potrebna (not applicable).
English: Adverse reactions based on pooled dataset from 5 studies (N=494) System organ class Frequency Preferred term
Slovenian: Neželeni učinki na podlagi združene zbirke podatkov iz 5 študij (n = 494) Organski sistem Pogostnost Priporočeni izraz
English: This is probably the net effect of both P-gp induction and inhibition by rifampin under the tested conditions in the drug-drug interaction study.
Slovenian: To je verjetno neto učinek indukcije P-gp in inhibicije z rifampicinom pod preskušanimi pogoji v študiji medsebojnega delovanja zdravil.
English: Efficacy data for EMBRACA based on the primary analysis as assessed by the independent review and investigator are summarised in Table 5.
Slovenian: Podatki o učinkovitosti iz študije EMBRACA na podlagi primarne analize, kot so jih ocenili z neodvisnim pregledom in po oceni raziskovalca, so povzeti v preglednici 5.
English: Curcumin is found in turmeric root and you should not use large amounts of turmeric root, but using spices in food is not likely to cause a problem.
Slovenian: Kurkumin najdemo v koreniki kurkume, zato večjih količin korenike kurkume ne smete uporabljati, vendar pa uporaba začimb v hrani verjetno ne bo povzročila težav.
English: Other medicines and Talzenna
Slovenian: Druga zdravila in zdravilo Talzenna
English: The study demonstrated a statistically significant improvement in PFS for Talzenna compared with chemotherapy (see Table 5).
Slovenian: Študija je pokazala statistično pomembno izboljšanje PFS pri zdravilu Talzenna v primerjavi s kemoterapijo (glejte preglednico 5).
English: The safety and efficacy of Talzenna in children and adolescents < 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Talzenna pri otrocih in mladostnikih, starih < 18 let, nista bili dokazani.
English: Abbreviations: CI=confidence interval; PFS=progression-free survival.
Slovenian: Okrajšave: IZ = interval zaupanja; PFS = preživetje brez napredovanja bolezni (progression-free survival).
English: What you need to know before you take Talzenna 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Talzenna 3.
English: The results have shown that age, sex, and body weight had no clinically relevant effect on the PK of talazoparib.
Slovenian: Rezultati so pokazali, da starost, spol in telesna masa nimajo klinično pomembnega učinka na FK talazopariba.
English: You will have regular blood tests during treatment with Talzenna to check your blood cells (white blood cells, red blood cells, and platelets).
Slovenian: Med zdravljenjem z zdravilom Talzenna boste imeli redne preiskave krvi za preverjanje vaših krvnih celic (bele krvne celice, rdeče krvne celice in krvne ploščice).
English: Children and adolescents Talzenna is not to be used in children or adolescents (under 18 years of age).
Slovenian: Otroci in mladostniki Zdravila Talzenna ni dovoljeno uporabljati pri otrocih ali mladostnikih (mlajših od 18 let).
English: f. Stratified CMH test.
Slovenian: Stratificirani test CMH.
English: Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 62.3% of patients receiving Talzenna.
Slovenian: Do prilagajanja odmerka (zmanjšanja odmerka ali prekinitve zdravljenja) zaradi kateregakoli neželenega učinka je prišlo pri 62,3 % bolnikov, ki so prejemali zdravilo Talzenna.
English: b. Stratified Log-rank test. c. 51% of the projected final number of OS events occurred (163 of 321 deaths).
Slovenian: Zgodilo se je 51 % predvidenega končnega števila dogodkov (163 od 321 smrti).
English: They can be taken with or without food (see section 5.2).
Slovenian: Kapsule lahko jemljemo s hrano ali brez nje (glejte poglavje 5.2).
English: If you forget to take Talzenna
Slovenian: Če ste pozabili vzeti zdravilo Talzenna
English: Talzenna with food and drink
Slovenian: Zdravilo Talzenna skupaj s hrano in pijačo
English: It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor'.
Slovenian: Gre za vrsto zdravila proti raku, ki je znano kot ''zaviralec PARP (poli-ADP-riboza polimeraze)''.
English: Median age (y [range]) Age category (y), n (%)
Slovenian: Mediana starost (y [razpon]) Starostna kategorija (y), n (%)
English: Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer.
Slovenian: Pri bolnikih s spremembami (mutacijami) v genih BRCA obstaja tveganje za pojav nekaterih oblik raka.
English: Contact with the capsule content should be avoided.
Slovenian: Izogibajte se stiku z vsebino kapsule.
English: Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Talzenna mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: No significant effect of acid-reducing agents on talazoparib exposure is expected, given sufficient solubility of talazoparib at all pHs between 1 and 6.8.
Slovenian: Pomembnega učinka zdravil za zmanjševanje kisline na izpostavljenost talazoparibu ni pričakovati, saj je talazoparib dovolj topen pri vseh vrednostih pH od 1 do 6,8.
English: What Talzenna is and what it is used for 2.
Slovenian: Kaj je zdravilo Talzenna in za kaj ga uporabljamo 2.
English: Talazoparib should not be started until patients have recovered from haematological toxicity caused by previous therapy (≤ Grade 1).
Slovenian: Zdravljenja s talazoparibom ne smemo začeti, dokler bolniki ne okrevajo po hematološki toksičnosti, ki je posledica predhodnega zdravljenja (≤ stopnja 1).
English: Randomised Phase 3 study EMBRACA
Slovenian: Randomizirana študija 3. faze EMBRACA
English: Your healthcare provider will perform a test to make sure that Talzenna is right for you.
Slovenian: Zdravstveni delavec bo opravil preiskavo za potrditev, da je zdravilo Talzenna pravo za vas.
English: If you get certain side effects while you are taking Talzenna (see section 4), your doctor may lower your dose or stop treatment, either temporarily or permanently.
Slovenian: Če se vam med jemanjem zdravila Talzenna pojavijo določeni neželeni učinki (glejte poglavje 4), vam bo zdravnik morda zmanjšal odmerek ali prekinil zdravljenje, bodisi začasno bodisi trajno.
English: No deaths were reported due to myelosuppression-related adverse reactions.
Slovenian: O smrtnih izidih kot posledici neželenih učinkov, povezanih z mielosupresijo, niso poročali.
English: Following repeated daily dosing, plasma talazoparib concentrations reached steady-state within 2 to 3 weeks.
Slovenian: Po ponavljajočem se vsakodnevnem dajanju so koncentracije talazopariba v plazmi dosegle stanje dinamičnega ravnovesja v 2 do 3 tednih.
English: The European Medicines Agency has waived the obligation to submit the results of studies with talazoparib in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s talazoparibom za vse podskupine pediatrične populacije pri raku dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Talzenna may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Talzenna ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English:  Grade 1
Slovenian:  stopnja 1
English: In this PDX model talazoparib decreased tumour growth and increased γH2AX level and apoptosis in the tumours.
Slovenian: Pri tem modelu PDX je talazoparib zmanjšal rast tumorja in povečal raven γH2AX ter apoptozo v tumorjih.
English: Black or African American White
Slovenian: Azijci temnopolti ali Afroameričani belci drugo niso navedli
English: Fertility Talazoparib may reduce fertility in men.
Slovenian: Plodnost Talazoparib lahko zmanjša plodnost pri moških.
English: Dose modification and management Withhold Talzenna until levels resolve to
Slovenian: Prilagajanje in uravnavanje odmerkov Prekinite zdravljenje z zdravilom Talzenna, dokler ravni ne dosežejo
English: Talazoparib is a substrate of P-gp and BCRP transporters.
Slovenian: Talazoparib je substrat prenašalcev P-gp in BCRP.
English: OTHER SPECIAL WARNING(S), IF NECESSARY 8.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA