natgillin/translations-raw huggingface dataset:
Andre P-gp-induktorer (herunder blandt andet carbamazepin, phenytoin og prikbladet perikon) kan nedsætte eksponeringen for talazoparib.
Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John's wort) may decrease talazoparib exposure.
Hormonreceptorpositiv (ER-positiv eller PgR-positiv) BRCA-status ud fra vurdering af centralt eller lokalt laboratorium, n (%)
BRCA status by central or local laboratory assessment, n (%)
Virkningen af talazoparib på repolarisering af hjertet hos 37 patienter med fremskredne solide tumorer blev undersøgt med tidsbestemte elektrokardiogrammer (EKG'er) for at vurdere forholdet mellem ændringer i QT-intervallet korrigeret for hjertefrekvens (QTc) fra baseline og de tilhørende plasmatalazoparib-koncentrationer.
The effect of talazoparib on cardiac repolarisation was evaluated using time-matched electrocardiograms (ECGs) in assessing the relationship between the change of the QT interval corrected for heart rate (QTc) from baseline and the corresponding plasma talazoparib concentrations in 37 patients with advanced solid tumours.
Tal med din læge om, hvilken prævention der kan være den rigtige for dig.
Talk to your healthcare provider about birth control methods that may be right for you.
Aktivt stof: talazoparib.
The active substance is talazoparib.
Talzenna 0,25 mg fås i perforerede blisterpakninger med 30, 60 eller 90 hårde kapsler og i plastbeholdere med 30 hårde kapsler.
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.
Omfatter de foretrukne termer for neutropeni og nedsat neutrofiltal.
c. Includes preferred terms of neutropenia and neutrophil count decreased.
Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Det skal du vide, før du begynder at tage Talzenna
What you need to know before you take Talzenna
Talzenna 0,25 mg hårde kapsler EU/1/19/1377/001
Talzenna 0.25 mg hard capsules EU/1/19/1377/001
- Hvis du ammer.
If you are breast-feeding.
Median PFS=5,6 måneder 95% CI (4,2; 6,7)
Chemotherapy Median PFS=5.6 months 95% CI (4.2, 6.7)
BRCA2-positiv
BRCA2-mutation positive
Talzenna nedsætter antallet af blodlegemer som f. eks. antallet af røde blodlegemer (blodmangel eller anæmi), antallet af hvide blodlegemer (neutropeni) eller antallet af blodplader (trombocytopeni).
Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia).
Virkningen af BCRP-hæmmere på talazoparibs farmakokinetik er ikke blevet undersøgt in vivo.
The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo.
Data fra et interaktionsstudie af lægemidler hos patienter med fremskredne, solide tumorer indikerede, at samtidig administration af 1 enkelt dosis 1 mg talazoparib med flere daglige doser af P-gpinduktoren rifampin 600 mg, hvor rifampin blev administreret 30 minutter før talazoparib på dagen, hvor talazoparib blev doseret, øgede talazoparib Cmax med ca. 37%, hvorimod AUCinf ikke blev påvirket i forhold til 1 enkelt dosis 1 mg talazoparib administreret alene.
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.
Talazoparib hæmmer ikke cytokrom (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4/5 eller CYP1A2, CYP2B6 eller CYP3A4 in vitro ved klinisk relevante koncentrationer.
In vitro, talazoparib was not an inhibitor of cytochrome (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 or inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Der kræves ingen dosisjustering for patienter med let nedsat leverfunktion (total bilirubin ≤ 1 × øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) > ULN eller total bilirubin > 1,0-1,5 × ULN og enhver ASAT).
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤ 1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST).
C)talazoparib til mennesker blev der ikke fundet større cirkulerende metabolitter i plasmaet, og talazoparib var eneste cirkulerende lægemiddelrelaterede stof.
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.
Samtidig administration af talazoparib og BCRP-hæmmere kan øge eksponeringen for talazoparib.
Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure.
Data fra et interaktionsstudie af lægemidler hos patienter med fremskredne, solide tumorer indikerede, at samtidig administration af flere daglige doser af P-gp-hæmmeren itraconazol 100 mg 2 gange dagligt med en enkelt dosis 0,5 mg talazoparib, øgede den samlede eksponering af talazoparib (AUCinf) og den maksimale koncentration (Cmax) med henholdsvis ca. 56 % og 40 % sammenlignet med en enkelt dosis på 0,5 mg talazoparib administreret alene.
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.
De mest almindelige (≥ 10 %) grad ≥ 3 bivirkninger af talazoparib var anæmi (35,2%), neutropeni (17,4%) og thrombocytopeni (16,8%).
The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Omfatter de foretrukne termer for træthed og asteni.
h. Includes preferred terms of fatigue and asthenia.
Den generelle sikkerhedsprofil for Talzenna bygger på poolede data fra 494 patienter, der fik talazoparib 1 mg dagligt i kliniske studier af solide tumorer, herunder 286 patienter fra et randomiseret fase 3-studie med germline BRCA-muteret (gBRCAm), lokalt fremskreden eller metastatisk HER2
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.
Talzenna 1 mg fås i perforerede blisterpakninger med 30 hårde kapsler og plastbeholdere med 30 hårde kapsler.
Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.
Talzenna må kun bruges til patienter med kraftigt nedsat nyrefunktion, hvis fordelene opvejer de mulige risici, og patienten skal nøje monitoreres med hensyn til nyrefunktion og bivirkninger (se pkt.
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).
Der skal foretages en graviditetstest af alle fertile kvinder forud for behandling (se pkt.
A pregnancy test should be performed on all women of childbearing potential prior to treatment (see section 4.4).
Virkningen på eksponeringen for talazoparib af andre P-gp-induktorer er dog ikke undersøgt.
However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Printblæk: Shellak (E904), propylenglycol (E1520), ammoniumhydroxid (E527), sort jernoxid (E172) og kaliumhydroxid (E525).
Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Baseret på en farmakokinetisk analyse, der omfattede 490 patienter, hvoraf 118 patienter havde let nedsat leverfunktion (total bilirubin ≤ 1,0× ULN og ASAT > ULN, eller total bilirubin > 1,01,5 × ULN og enhver ASAT), havde en let nedsat leverfunktion ingen virkning på farmakokinetikken for talazoparib.
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.
BRCA1-positiv
BRCA1-mutation positive
Talazoparib hæmmer ikke nogen af de større intestinale, hepatiske eller renale membrantransportproteiner (P-gp, BCRP, organisk anion-transporterende polypeptid (OATP)1B1, OATP1B3, organisk kationtransportør (OCT)1, OCT2, organisk aniontransportør (OAT)1, OAT3, galde-salt-eksportpumpe (BSEP), multidrug og toksinekstrudering (MATE)1 og MATE2-K) in vitro ved klinisk relevante koncentrationer.
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.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and the bottle or blister after EXP.
Asiatisk
Asian
Alle grader* n (%)
All grades* n (%)
- infektion, kuldegysninger eller rysten, feber eller føle sig varm - det kan være tegn på et lavt antal hvide blodlegemer (neutropeni).
Infection, developing chills or shivering, or fever or feeling hot - these may be signs of a low white blood cell count (neutropenia).
Da brugen af hormonal kontraception ikke kan anbefales til patienter med brystkræft, skal der anvendes 2 ikke-hormonale svangerskabsforebyggende metoder.
Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used.
Omfatter de foretrukne termer for leukopeni og nedsat antal hvide blodlegemer.
d. Includes preferred terms of leucopenia and white blood cell count decreased.
ORR (%, 95 % CI) Odds ratio (95 % CI) 2-sidet p-værdi p < 0,0001
ORR (%, 95% CI) Odds ratio (95% CI) 2-sided p-valuef p<0.0001
P-gp er sandsynligvis involveret i aktiv udskillelse af talazoparib via nyrerne.
P-gp is likely involved in talazoparib active renal secretion.
Platin
Platinum
Enkeltdoser i perforeret blister i polyvinylklorid/polyvinylidenklorid (PVC/PVdC) med aluminiumsfolie til at trække af.
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding.
Omfatter de foretrukne termer for thrombocytopeni og nedsat trombocyttal.
a. Includes preferred terms of thrombocytopenia and platelet count decreased.
- blå mærker eller du bløder længere end normalt, hvis du får et sår - det kan være tegn på et lavt antal blodplader (trombocytopeni).
Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia).
Fertile kvinder/kontraception til mænd og kvinder
Male and female contraception
De mest almindelige bivirkninger, der førte til dosisændring, var anæmi (33,0%), neutropeni (15,8%) og thrombocytopeni (13,4%).
The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Talzenna bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender kontraception (se pkt.
Talzenna is not recommended during pregnancy or for women of childbearing potential not using contraception (see section 4.4).
Hændelser, antal (%) Median (95 % CI), måneder Hazard ratio (95 % CI) 2-sidet p-værdi p= 0,1053
Events, number (%) Median (95% CI), months Hazard ratio (95% CI) 2-sided p-valueb p=0.1053
- Trombocytopeni: blå mærker eller at du bløder længere tid end normalt, hvis du får et sår - det kan være tegn på et lavt antal blodplader.
Thrombocytopenia: Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count
Myelosuppression bestående af anæmi, leukopeni/neutropeni og/eller thrombocytopeni er blevet indberettet hos patienter, der er blevet behandlet med talazoparib (se pkt.
Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8).
Talzenna er ikke undersøgt hos patienter med kraftigt nedsat nyrefunktion (CrCl < 30 ml/min.)
Talzenna has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or patients requiring haemodialysis.
Talzenna 1 mg hårde kapsler
Talzenna 1 mg hard capsules
- Neutropeni: infektion, får kuldegysninger eller rysten eller feber - det kan være tegn på et lavt antal hvide blodlegemer.
Neutropenia: Infection, developing chills or shivering, or fever - these may be signs of a low white blood cell count
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Pakningsstørrelse: Kartoner med 30 kapsler i en HDPE-beholder.
Pack size: cartons of 30 capsules in a HDPE bottle.
Hård kapsel 30 × 1 kapsler
30 × 1 capsules
Da brugen af hormonal kontraception ikke kan anbefales til patienter med brystkræft, skal der anvendes 2 ikke-hormonale svangerskabsforebyggende metoder (se pkt.
Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used (see section 4.6).
Omfatter de foretrukne termer for nedsat lymfocyttal og lymfopeni.
e. Includes preferred terms of lymphocyte count decreased and lymphopenia.
0,75 mg (tre 0,25 mg kapsler) 1 gang dagligt
0.75 mg (three 0.25 mg capsules) once daily
- Johannesurt/perikon (Hypericum perforatum), et naturlægemiddel, der bruges til nedtrykthed,
St. John's wort (Hypericum perforatum) - a herbal remedy used to treat mild depression and anxiety.
Den vigtigste udskillelsesvej for talazoparib er renal udskillelse af uomdannet lægemiddel (passiv filtrering og aktiv udskillelse).
Renal elimination of unchanged drug (passive filtration and active secretion) is the major route of talazoparib elimination.
De kan tages med eller uden mad og drikke (se pkt.
OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
4.7 Effects on ability to drive and use machines Talzenna may have a minor influence on the ability to drive and use machines.
Pakningsstørrelse: Karton med 30 × 1 kapsler i blister med enhedsdoser.
Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Der kræves ingen dosisjustering for patienter med let nedsat nyrefunktion (60 ml/min.
No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine clearance [CrCl] < 90 mL/min).
Kvinder, der kan blive gravide, skal bruge en sikker form for prævention, mens de bliver behandlet med Talzenna og i mindst 7 måneder efter sidste dosis Talzenna.
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.
Silicificeret mikrokrystalinsk cellulose (sMCC) (mikrokrystallinsk cellulose og siliciumdioxid)
Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 0.25 mg capsule shell
Virkningen af syrenedsættende stoffer
Effect of acid-reducing agents
Farmakokinetikken for talazoparib er ikke undersøgt for patienter, der har brug for hæmodialyse (se pkt.
The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2).
Hård kapsel 30 kapsler
30 capsules
Talzenna 0,25 mg hårde kapsler
Talzenna 0.25 mg hard capsules
4) før, de indleder behandling med talazoparib, under behandlingen og 7 måneder efter seponering af behandling med talazoparib.
Women of childbearing potential must use highly effective forms of contraception (see section 4.4) prior to starting treatment with talazoparib, during treatment, and for 7 months after stopping treatment with talazoparib.
Den samlede responsrate var 5,5 % for talazoparib sammenlignet med 0 % for kemoterapiarmen.
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.
Omfatter de foretrukne termer for anæmi, nedsat hæmatokrit og nedsat hæmoglobin.
b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased.
Hændelser, antal (%) Median (95 % CI), måneder Hazard ratio a (95 % CI) 2-sidet p-værdi p < 0,0001
Events, number (%) Median (95% CI), months Hazard ratioa (95% CI) 2-sided p-valueb p<0.0001
Farmakokinetikken for talazoparaib er ikke undersøgt for patienter med moderat (total bilirubin > 1,5-3,0 × ULN og evt. ASAT) eller svært nedsat leverfunktion (total bilirubin > 3,0 × ULN og evt. ASAT) (se pkt.
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).
Det anbefales ikke at bruge Talzenna til patienter med kraftigt nedsat nyrefunktion eller med behov for hæmodialyse (se pkt.
Talzenna is not recommended for use in patients with severe renal impairment or requiring haemodialysis (see section 5.2).
0,5 mg (to 0,25 mg kapsler) 1 gang dagligt
0.5 mg (two 0.25 mg capsules) once daily
Talazoparib var clastogent i en in vitro-kromosomaberrationsanalyse i humane, perifere blodlymfocytter og i en in vivomikronukleusanalyse af rotter ved en eksponering svarende til klinisk relevante doser.
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.
Inden behandlingsstart med Talzenna skal der foretages en komplet blodtælling, og der skal monitoreres månedligt og i henhold til den kliniske indikation (se tabel 2 og pkt.
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).
Mandlige patienter med kvindelige fertile partnere eller gravide partnere skal rådes til at anvende sikker kontraception (selv efter vasektomi) under behandlingen med Talzenna og i mindst 4 måneder efter sidste dosis.
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.
Talzenna 0,25 mg hårde kapsler Talzenna 1 mg hårde kapsler talazoparib
Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib
Kontraception til fertile kvinder
Contraception in women of childbearing potential
Talazoparib var clastogent i en in vitro-kromosomskade-analyse af humane, perifere blodlymfocytter og i en in vivo-knoglemarvsmikronukleus-analyse af rotter, men ikke mutagent i Ames-test (se pkt.
Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman.
Meget almindelig (kan påvirke flere end 1 ud af 10 personer) - lavt antal hvide blodlegemer, røde blodlegemer og blodplader - nedsat appetit - svimmelhed - hovedpine - kvalme - kaste op - diarré - smerter i mave/underliv - hårtab
Very common (may affect more than 1 in 10 people) Low counts of white blood cells, red blood cells, and blood platelets Decreased appetite
For 6 kvindelige patienter, der fik en enkelt oral dosis C)talazoparib, blev i gennemsnit 69 % (±8,6%) og 20% (±5,5%) af den samlede radioaktive dosis, der blev administreret, fundet i henholdsvis urin og fæces.
In 6 female patients given a single oral dose of [14C]talazoparib, a mean of 69% (±8.6%) and 20%
Mandlige patienter med kvindelige fertile partnere eller gravide partnere skal rådes til at anvende sikker kontraception (selv efter vasektomi) under behandlingen med Talzenna og i mindst 4 måneder efter sidste dosis (se pkt.
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).
Talzenna blokerer et enzym, der reparerer beskadiget DNA i kræftcellerne, så kræftcellerne ikke kan reparere sig selv og dermed dør.
Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells.
Hud og subkutane væv Meget almindelig Alopeci
Skin and subcutaneous tissue disorders
- Talzenna 0,25 mg hårde kapsler: hver kapsel indeholder talazoparibtosylat svarende til 0,25 mg talazoparib.
Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Kvalme
Headache
Randomiseringen blev stratificeret ud fra forudgående brug af kemoterapi mod metastatisk sygdom (0 vs. 1, 2 eller 3), triple negativ sygdomsstatus (triple negativ brystkræft (TNBC) sammenlignet med ikke-TNBC) samt metastaser i centralnervesystemet i anamnesen (ja vs. nej).
Of the 431 patients randomised onto EMBRACA, 287 were randomised to the Talzenna arm and 144 to the chemotherapy arm. Randomisation was stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non-TNBC), and history of central nervous system metastasis (yes versus no).
Derfor anbefales amning ikke under behandling med Talzenna og i mindst 1 måned efter den sidste dosis.
A risk to breast-fed children cannot be excluded and therefore breast-feeding is not recommended during treatment with Talzenna and for at least 1 month after the final dose.
Kapslerne må ikke åbnes, knuses eller tygges.
Do not open, crush or chew the capsules.
Hazard ratio var baseret på en stratificeret Cox-regressionsmodel med behandling som eneste kovariant (stratificeringsfaktorer: antal forudgående behandlinger med cytotoksisk kemoterapi, triple-negative-status, CNS metastaser i anamnesen) og var i forhold til samlet kemoterapi med < 1 til fordel for talazoparib.
(stratification factors: number of prior cytotoxic chemotherapy regimens, triple-negative status, history of central nervous system metastasis) and was relative to overall chemotherapy with < 1 favouring talazoparib.
Talzenna 0,25 mg kapsler talazoparib
NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg capsules talazoparib
Talzenna 1 mg leveres som uigennemsigtige ca. 14,30 mm x 5,32 mm hårde kapsler med svagt rød overdel (påtrykt ”Pfizer” med sort skrift) og hvid underdel (påtrykt ”TLZ 1” med sorte skrift).
Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
- 0,25 mg kapselskal: Hypromellose (HPMC), gul jernoxid (E172) og titandioxid (E171) - 1 mg kapselskal: Hypromellose (HPMC), gul jernoxid (E172), titandioxid (E171) og rød jernoxid (E172)
1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Dyspepsi
Diarrhoea