natgillin/translations-raw huggingface dataset:
Based on a population PK analysis that included 490 patients, where 41 patients were Asian and 449 patients were Non-Asian (361 White, 16 Black, 9 Others, and 63 Not reported), talazoparib CL/F was higher in Asian patients compared to Non-Asian patients, leading to 19% lower exposure (AUC) in Asian patients.
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih je 41 bolesnik bio azijskog porijekla, a 449 bolesnika nisu bili azijskog porijekla (361 pripadnik bijele rase, 16 pripadnika crne rase, 9 ostalih, dok 63 bolesnika nisu prijavila rasu), prividni peroralni klirens talazopariba bio je veći u bolesnika azijskog porijekla, u usporedbi s bolesnicima koji nisu bili azijskog porijekla, što vodi 19 % nižoj izloženosti (AUC) u bolesnika azijskog porijekla.
Very common (may affect more than 1 in 10 people) Being short of breath, feeling very tired, having pale skin, or fast heartbeat - these may be signs of a low red blood cell count (anaemia).
Vrlo često (mogu se javiti kod više od 1 na 10 osoba) - Nedostatak zraka, osjećaj velikog umora, blijeda koža ili brzi otkucaji srca - to mogu biti znakovi niskog broja eritrocita (anemija).
EMBRACA was an open-label, randomised, parallel, 2-arm multicentre study of Talzenna versus chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) in patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease.
EMBRACA je bilo otvoreno, randomizirano, paralelno, multicentrično ispitivanje na dvije skupine lijeka Talzenna u odnosu na kemoterapiju (kapecitabin, eribulin, gemcitabin, vinorelbin) u bolesnika s lokalno uznapredovalim ili metastatskim HER2-negativnim rakom dojke s mutiranim BRCA genom u zametnim stanicama koji prethodno nisu primili više od 3 režima citotoksične kemoterapije za svoju metastatsku ili lokalno uznapredovalu bolest.
Infection, developing chills or shivering, or fever or feeling hot - these may be signs of a low white blood cell count (neutropenia).
- Infekcija, pojavljivanje zimica ili drhtanja, ili vrućica ili se osjećate vruće - to mogu biti znakovi niskog broja leukocita (neutropenija).
Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.
Talzenna od 1 mg dostupna je u perforiranim blister pakiranjima s jediničnim dozama, koja sadrže 30 tvrdih kapsula, i u plastičnim bočicama s 30 tvrdih kapsula.
Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) BRCA mutant breast cancer model where the patient was previously treated with a platinum-based regimen.
Antitumorska aktivnost talazopariba zabilježena je i u modelu ksenografta bolesnika s rakom dojke s mutacijom gena BRCA kod kojeg je bolesnik prethodno bio liječen režimom na bazi platine.
Chemotherapy Median PFS=5.6 months 95% CI (4.2, 6.7)
Medijan PFS-a=5,6 mjeseci 95% CI (4,2; 6,7)
Platelet count < 50,000/μL
Broj trombocita < 50 000/μl
Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia).
- Dobivanje modrica ili krvarenje koje traje duže nego je to uobičajeno kada se ozlijedite - to mogu biti znakovi niskog broja trombocita (trombocitopenija).
Talzenna 0.25 mg hard capsules EU/1/19/1377/001
Talzenna 0,25 mg tvrde kapsule EU/1/19/1377/001
Do not open, crush or chew the capsules.
Kapsule nemojte otvarati, lomiti niti žvakati.
Asian
Azijska
c. Includes preferred terms of neutropenia and neutrophil count decreased.
Uključuje preporučene pojmove: neutropenija i smanjen broj neutrofila.
The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2).
Farmakokinetika talazopariba nije ispitivana u bolesnika kojima je potrebna hemodijaliza (vidjeti dio 4.2).
Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.
Talzenna se koristi za liječenje odraslih s tipom raka dojke poznatim kao rak dojke negativan na receptor HER2, koji ima naslijeđeni abnormalni BRCA genom.
EU/1/19/1377/002 (30 hard capsules) EU/1/19/1377/003 (60 hard capsules) EU/1/19/1377/004 (90 hard capsules)
EU/1/19/1377/002 (30 tvrdih kapsula) EU/1/19/1377/003 (60 tvrdih kapsula) EU/1/19/1377/004 (90 tvrdih kapsula)
If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to 0.75 mg once daily.
P-gp-a ne može izbjeći, potrebno je smanjiti dozu lijeka Talzenna na 0,75 mg jednom na dan.
Based on a population PK analysis that included 490 patients, where 132 patients had mild renal impairment (60 mL/min ≤ CrCL < 90 mL/min), 33 patients had moderate renal impairment (30 mL/min ≤ CrCL < 60 mL/min), and 1 patient had severe renal impairment (CrCL < 30 mL/min), talazoparib CL/F was decreased by 14% and 37% in patients with mild and moderate renal impairment, respectively, when compared to patients with normal renal function (CrCL ≥ 90 mL/min).
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih su 132 bolesnika imala blago oštećenje funkcije bubrega (60 ml/min ≤ CrCL < 90 ml/min), 33 bolesnika umjereno oštećenje funkcije bubrega (30 ml/min ≤ CrCL < 60 ml/min), a 1 bolesnik teško oštećenje funkcije bubrega (CrCL < 30 ml/min), prividni peroralni klirens talazopariba smanjio se za 14 %, odnosno 37 % u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega, u usporedbi s bolesnicima s normalnom funkcijom bubrega (CrCL ≥ 90 ml/min).
Talzenna 0.25 mg is available in perforated unit dose blister packs of 30, or 60, or 90 hard capsules and in plastic bottles of 30 hard capsules.
Talzenna od 0,25 mg dostupna je u perforiranim blister pakiranjima s jediničnim dozama, koja sadrže 30, 60 ili 90 tvrdih kapsula, i u plastičnim bočicama s 30 tvrdih kapsula.
Abbreviations: aBC=advanced breast cancer; CI=confidence interval; CNS=central nervous system; HR+=hormone receptor-positive; ITT=intent-to-treat; PCT=physician's choice treatment (chemotherapy); PFS=progression-free survival; TNBC=triple-negative breast cancer.
CNS=središnji živčani sustav (engl. central nervous system); HR+=s pozitivnim hormonskim receptorima; ITT=populacija predviđena za liječenje; PCT=liječnikov odabir liječenja (kemoterapija); PFS=preživljenje bez progresije bolesti; TNBC=trostruko negativni rak dojke (engl. triple-negative breast cancer).
If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.
Ako imate bilo kakvih pitanja u vezi djelovanja lijeka Talzenna ili razloga zašto
The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo.
Učinak inhibitora BCRP-a na farmakokinetiku talazopariba nije ispitivan in vivo.
Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure.
Istodobna primjena talazopariba s inhibitorima BCRP-a može povećati izloženost talazoparibu.
Based on a population PK analysis that included 490 patients, where 118 patients had mild hepatic impairment (total bilirubin ≤ 1.0 × ULN and AST > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the PK of talazoparib.
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih je 118 bolesnika imalo blago oštećenje funkcije jetre (ukupni bilirubin ≤ 1,0 × GGN i AST > GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN i bilo koji AST), blago oštećenje funkcije jetre nije imalo učinka na farmakokinetiku talazopariba.
Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia).
Talzenna smanjuje broj Vaših krvnih stanica, poput broja eritrocita (anemija), leukocita (neutropenija) ili broja trombocita (trombocitopenija).
Hormone receptor status, n (%)
Nedostaje Status hormonskih receptora, n (%) HER2-pozitivan
In vitro, talazoparib did not inhibit any of the major intestinal, hepatic or renal membrane transporters (P-gp, BCRP, organic anion transporting polypeptide [OATP]1B1, OATP1B3, organic cationic transporter [OCT]1, OCT2, organic anion transporter [OAT]1, OAT3, bile salt export pump [BSEP], multidrug and toxin extrusion [MATE]1 and MATE2-K) at clinically relevant concentrations.
In vitro, talazoparib nije inhibirao nijedan od glavnih membranskih prijenosnika za crijeva, jetru ili bubrege (P-gp, BCRP, organski anionski transportni polipeptid [OATP]1B1, OATP1B3, transporter organskog kationa [OCT]1, OCT2, transporter organskog aniona [OAT]1, OAT3, pumpu za izvoz žučnih soli [BSEP], proteine ekstruzije više lijekova i toksina [MATE]1 i MATE2-K) pri klinički značajnim koncentracijama.
The overall safety profile of Talzenna is based on pooled data from 494 patients who received talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 patients from a randomised Phase 3 study with germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer and 83 patients from a nonrandomised Phase 2 study in patients with germline BRCA-mutated locally advanced or metastatic breast cancer.
Ukupni profil sigurnosti primjene lijeka Talzenna temelji se na skupnim podacima 494 bolesnika koji su primali talazoparib u dozi od 1 mg dnevno u kliničkim ispitivanjima solidnih tumora, uključujući 286 bolesnika iz randomiziranog ispitivanja faze 3 s lokalno uznapredovalim ili metastatskim HER2negativnim rakom dojke s mutiranim BRCA genom u zametnim stanicama (gBRCAm) i 83 bolesnika iz nerandomiziranog ispitivanja faze 2 na bolesnicima s lokalno uznapredovalim ili metastatskim rakom dojke s mutiranim BRCA genom u zametnim stanicama.
BRCA mutation status (breast cancer susceptibility gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across both treatment arms.
BRCA (pozitivan gen 1 sklonosti za rak dojke [BRCA1] ili pozitivan gen 2 sklonosti za rak dojke [BRCA2]) bio je sličan u obje liječene skupine.
f. Includes preferred terms of abdominal pain, abdominal pain upper, abdominal discomfort and abdominal pain lower.
Uključuje preporučene pojmove: bol u abdomenu, bol u gornjem dijelu abdomena, nelagoda u abdomenu i bol u donjem dijelu abdomena.
Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Tinta za označavanje: šelak (E904), propilenglikol (E1520), amonijev hidroksid (E527), crni željezov oksid (E172) i kalijev hidroksid (E525).
Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).
Silicifirana mikrokristalična celuloza (mikrokristalična celuloza i silicijev dioksid)
Summary of efficacy results - EMBRACA study Talazoparib
Tablica 5. Sažetak rezultata djelotvornosti - ispitivanje EMBRACA Talazoparib
There is limited experience of overdose with talazoparib.
Iskustvo s predoziranjem s talazoparibom je ograničeno.
Following oral administration of a single 1 mg dose of [14C]talazoparib to humans, no major circulating metabolites were identified in plasma, and talazoparib was the only circulating drug-derived entity identified.
C] u ljudi nije pronađen nijedan glavni cirkulirajući metabolit u plazmi, a talazoparib je bio jedini zabilježeni cirkulirajući entitet dobiven iz lijeka.
Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day.
Anemija, neutropenija i trombocitopenija, nuspojave povezane s mijelosupresijom, bile su vrlo često zabilježene u bolesnika liječenih talazoparibom u dozi od 1 mg/dan.
To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved.
Kapsule je potrebno progutati cijele te se ne smiju otvarati niti otopiti kako bi se izbjegao kontakt sa sadržajem kapsule.
Talzenna is for oral use.
Talzenna se primjenjuje peroralno.
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner.
Bočica od polietilena visoke gustoće (HDPE) sa polipropilenskim (PP) zatvaračem, zatvorena zaštitnom folijom.
30 capsules
Tvrda kapsula 30 kapsula
Repeat-dose toxicity
Toksičnost kod ponavljane doze
Swallow whole.
Progutajte ih cijele.
Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co-administration of multiple daily doses of a P-gp inhibitor, itraconazole 100 mg twice daily with a single 0.5 mg talazoparib dose increased talazoparib total exposure (AUCinf) and peak concentration (Cmax) by approximately 56% and 40%, respectively, relative to a single 0.5 mg talazoparib dose administered alone.
Podaci iz ispitivanja interakcije između lijekova u bolesnika s uznapredovalim solidnim tumorima pokazali su da je istodobna primjena višekratnih dnevnih doza inhibitora P-gp-a, itrakonazola od 100 mg dva puta dnevno s jednokratnom dozom talazopariba od 0,5 mg, povećala ukupnu izloženost talazoparibu (AUCinf) i vršnu koncentraciju talazopariba (Cmax) za približno 56 %, odnosno 40 %, u usporedbi s jednokratnom dozom talazopariba od 0,5 mg kada se primjenjuje sam.
Women who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna.
Žene koje mogu zatrudnjeti moraju koristiti učinkovite metode protiv začeća (kontracepciju) tijekom liječenja lijekom Talzenna te najmanje 7 mjeseci nakon zadnje doze lijeka Talzenna.
The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Najčešće (≥ 10 %) nuspojave talazopariba stupnja ≥ 3 bile su anemija (35,2 %), neutropenija (17,4 %) i trombocitopenija (16,8 %).
Time from initial diagnosis of breast cancer to diagnosis of advanced breast cancer (years) n
Kategorije za vrijeme od početne dijagnoze raka dojke do dijagnoze uznapredovalog raka dojke < 12 mjeseci ≥ 12 mjeseci
Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co-administration of single 1 mg talazoparib dose with multiple daily doses of a P-gp inducer, rifampin 600 mg, with rifampin co-administered 30 minutes before talazoparib on the day of talazoparib dosing, increased talazoparib Cmax by approximately 37% whereas AUCinf was not affected relative to a single 1 mg talazoparib dose administered alone.
Podaci iz ispitivanja interakcije između lijekova u bolesnika s uznapredovalim solidnim tumorima pokazali su da je istodobna primjena jednokratne doze talazopariba od 1 mg s višekratnim dnevnim dozama induktora P-gp-a, rifampina od 600 mg, pri čemu se rifampin istodobno primjenjivao 30 minuta prije talazopariba na dan primjene doze talazopariba, povećala Cmax talazopariba za približno 37 % dok nije bilo utjecaja na AUCinf , u usporedbi s jednokratnom dozom talazopariba od 1 mg kada se primjenjuje sam.
The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Najčešće nuspojave koje su dovele do promjena doze bile su anemija (33,0 %), neutropenija (15,8 %) i trombocitopenija (13,4 %).
Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Veličina pakiranja: kutije s 30 × 1 kapsula u blisterima s jediničnim dozama.
Talzenna is not recommended for use in patients with severe renal impairment or requiring haemodialysis (see section 5.2).
Ne preporučuje se primjena lijeka Talzenna u bolesnika s teškim oštećenjem bubrega ili bolesnika kojima je potrebna hemodijaliza (vidjeti dio 5.2).
The population mean apparent volume of distribution (Vss/F) of talazoparib was 420 L. In vitro, talazoparib is approximately 74% bound to plasma proteins with no concentration dependence over the concentration range of 0.01 µM to 1 µM.
In vitro vezanje talazopariba na proteine plazme iznosi približno 74 % bez ovisnosti o koncentraciji kod raspona koncentracije od 0,01 µM do 1 µM.
30 × 1 capsules
Tvrda kapsula 30 × 1 kapsula
Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo micronucleus assay in rats at exposures similar to clinically relevant doses.
Talazoparib je bio klastogen u in vitro testu aberacije kromosoma u humanim limfocitima periferne krvi i u in vivo mikronukleus testu u štakora pri izloženostima sličnim klinički značajnim dozama.
BCRP inhibitors
Inhibitori BCRP-a
If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see section 4.2).
P-gp-a ne može izbjeći, potrebno je smanjiti dozu lijeka Talzenna (vidjeti dio 4.2).
Frequency categories are defined as: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Nuspojave temeljene na objedinjenim nizovima podataka razvrstanim prema klasifikaciji organskih sustava i kategoriji učestalosti sažete su u tablici 3. Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10) i često (≥ 1/100 i < 1/10).
4.7 Effects on ability to drive and use machines Talzenna may have a minor influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Monoterapija lijekom Talzenna indicirana je za liječenje odraslih bolesnika s mutacijama gena BRCA1/2 u zametnim stanicama koji boluju od lokalno uznapredovalog ili metastatskog HER2-negativnog raka dojke.
Fatigue/asthenia or dizziness may occur following administration of talazoparib.
Umor/astenija ili omaglica se mogu pojaviti nakon primjene talazopariba.
Talzenna may only be used in patients with severe renal impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for renal function and adverse events (see section 5.2).
Lijek Talzenna smije se primjenjivati u bolesnika s teškim oštećenjem bubrega samo ako korist nadmašuje mogući rizik, dok je potrebno pozorno pratiti funkciju bubrega i moguću pojavu štetnih događaja u bolesnika (vidjeti dio
Events, number (%) Median (95% CI), months Hazard ratio (95% CI) 2-sided p-valueb p=0.1053
Događaji, broj (%) Medijan (95 % CI), mjeseci Omjer hazarda (95% CI) p-vrijednost dvostranog testa p = 0,1053
Talzenna 1 mg hard capsules
Talzenna 1 mg tvrde kapsule
A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Sve žene reproduktivne dobi moraju napraviti test na trudnoću prije liječenja.
Pack size: cartons of 30 capsules in a HDPE bottle.
Veličina pakiranja: kutije s 30 kapsula po HDPE bočici.
b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased.
Uključuje preporučene pojmove: anemija, smanjen hematokrit i smanjen hemoglobin.
Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib.
U bolesnika koji su primali inhibitore enzima poli (adenozin difosfat-riboza) polimeraze (PARP), uključujući talazoparib, prijavljeni su mijelodisplastični sindrom/akutna mijeloična leukemija (MDS/AML).
ORR (%, 95% CI) Odds ratio (95% CI) 2-sided p-valuef p<0.0001
ORR (%, 95 % CI) Omjer izgleda (95 % CI) p-vrijednost dvostranog testa p < 0,0001
0.75 mg (three 0.25 mg capsules) once daily
0,75 mg (tri kapsule od 0,25 mg) jednom na dan
Efficacy data for EMBRACA based on the primary analysis as assessed by the independent review and investigator are summarised in Table 5.
Podaci o djelotvornosti za ispitivanje EMBRACA temeljeni na primarnoj analizi prema neovisnoj procjeni i ispitivaču sažeti su u tablici 5. Kaplan-Meierove krivulje za PFS prikazane su na slici 1.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva Vrlo često Alopecija
Anthracycline
Antraciklin
Race, n (%)
Rasa, n (%)
Resume Talzenna at next lower dose
Nastavite uzimati sljedeću nižu dozu lijeka Talzenna
The PK of talazoparib have not been studied in patients with moderate (total bilirubin > 1.5 to 3.0 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3.0 × ULN and any AST) (see section 4.2).
Farmakokinetika talazopariba nije ispitivana u bolesnika s umjerenim (ukupni bilirubin > 1,5 do 3,0 × GGN i bilo koji AST) ili teškim oštećenjem funkcije jetre (ukupni bilirubin > 3,0 × GGN i bilo koji AST) (vidjeti dio 4.2).
0.5 mg (two 0.25 mg capsules) once daily
0,5 mg (dvije kapsule od 0,25 mg) jednom na dan
Progression-free survival by BICR
Preživljenje bez progresije bolesti prema BICR-u
0.25 mg (one 0.25 mg capsule) once daily Complete blood count should be obtained prior to starting Talzenna therapy and monitored monthly and as clinically indicated (see Table 2 and section 4.4).
Potrebno je pribaviti kompletnu krvnu sliku prije početka terapije lijekom Talzenna te je pratiti mjesečno i prema kliničkoj potrebi (vidjeti tablicu 2 i dio 4.4).
Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.
Breast Cancer Resistance Protein, BCRP) te se uglavnom izlučuje bubrežnim klirensom kao nepromijenjeni spoj.
The complete response rate was 5.5% for talazoparib compared to 0% for the chemotherapy arm. e. Per RECIST 1.1, confirmation of CR/PR was not required.
Ukupna stopa odgovora iznosila je 5,5 % za talazoparib u usporedbi s 0 % za skupinu liječenu kemoterapijom.
Effect of acid-reducing agents
Učinak lijekova koji smanjuju kiselinu
Events, number (%) Median (95% CI), months Hazard ratioa (95% CI) 2-sided p-valueb p<0.0001
Događaji, broj (%) Medijan (95 % CI), mjeseci Omjer hazarda a (95 % CI) p-vrijednost dvostranog testa p < 0,0001
Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy) during treatment with Talzenna, and for at least 4 months after the final dose (see section 4.4).
Muške bolesnike koji imaju partnerice reproduktivne dobi ili trudne partnerice treba savjetovati da koriste učinkovitu kontracepciju (čak i nakon vazektomije) tijekom liječenja lijekom Talzenna te najmanje 4 mjeseca nakon zadnje doze (vidjeti dio 4.4).
How to take Talzenna
Kako uzimati lijek Talzenna
1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Ovojnica kapsule od 1 mg hipromeloza (HPMC) crveni željezov oksid (E172) žuti željezov oksid (E172) titanijev dioksid (E171)
Dose modification and management Withhold Talzenna until levels resolve to
Ne uzimajte lijek Talzenna dok se razine ne vrate na
Carbamazepine and phenytoin - anti-epileptics used to treat seizures or fits.
Sljedeći lijekovi mogu smanjiti učinak lijeka Talzenna: - Karbamazepin i fenitoin - antiepileptici koji se koriste u liječenju epileptičkih ili drugih napadaja.
0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
Ovojnica kapsule od 0,25 mg hipromeloza (HPMC) žuti željezov oksid (E172) titanijev dioksid (E171)
e. Includes preferred terms of lymphocyte count decreased and lymphopenia.
Uključuje preporučene pojmove: smanjen broj limfocita i limfopenija.
How to store Talzenna
Kako čuvati lijek Talzenna
Men with female partners who are pregnant or able to become pregnant should use effective birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.
Muškarci koji imaju partnerice koje su trudne ili mogu zatrudnjeti moraju koristiti učinkovitu metodu protiv začeća (kontracepciju) , čak i nakon vazektomije, tijekom liječenja lijekom Talzenna te najmanje 4 mjeseca nakon zadnje doze.
However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
P-gp-a na izloženost talazoparibu nije ispitivana.
Talzenna 0.25 mg hard capsules
Talzenna 0,25 mg tvrde kapsule