natgillin/translations-raw huggingface dataset:
In population based PK analyses, patient age, bodyweight or race (including White and Japanese patients) were not significant covariates.
V populacijski farmakokinetični analizi starost bolnice, telesna masa ali rasa (vključno z belkami in japonskimi bolnicami) niso bile pomembne sospremenljivke.
Nausea events led to discontinuation in 2.3% of olaparib-treated patients (CTCAE Grade 2) and 0.8% of placebo-treated patients (CTCAE Grade 1); 0.8% and 0.4% of olaparib-treated patients discontinued treatment due to low grade (CTCAE Grade 2) vomiting and dyspepsia, respectively.
Primeri navzee so vodili do prenehanja zdravljenja pri 2,3 % bolnic, zdravljenih z olaparibom (2. stopnja po CTCAE), in pri 0,8 % bolnic, ki so prejemale placebo (1. stopnja po CTCAE); od bolnic, zdravljenih z olaparibom, je zaradi bruhanja oz. dispepsije nizke stopnje (2. stopnja po CTCAE) zdravljenje prenehalo 0,8 % bolnic oz. 0,4 % bolnic.
In this study 302 patients with a documented deleterious or suspected deleterious gBRCA mutation were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or physician's choice of chemotherapy (capecitabine 42%, eribulin 35%, or vinorelbine 17%) until progression or unacceptable toxicity.
V tej študiji so 302 bolnika s potrjeno škodljivo ali domnevno škodljivo mutacijo gBRCA v razmerju 2:1 randomizirali na prejemanje bodisi zdravila Lynparza (300 mg [2 x 150 mg v tabletah] dvakrat na dan) bodisi na kemoterapijo po zdravnikovi izbiri (42 % kapecitabin, 35 % eribulin ali 17 % vinorelbin), in sicer do napredovanja bolezni ali nesprejemljive toksičnosti.
If patients present with new or worsening respiratory symptoms such as dyspnoea, cough and fever, or an abnormal chest radiologic finding is observed, Lynparza treatment should be interrupted and prompt investigation initiated.
Če se pri bolniku pojavijo novi ali poslabšajo obstoječi dihalni simptomi, npr. dispneja, kašelj in zvišana telesna temperatura, ali je ugotovljen nenormalen radiološki izvid prsnih organov, je treba zdravljenje z zdravilom Lynparza prekiniti in takoj opraviti preiskave.
The safety and efficacy of olaparib in patients with gBRCA1/2-mutations who had HER2-negative metastatic breast cancer were studied in a Phase III randomised, open-label, controlled trial (OlympiAD).
Varnost in učinkovitost olapariba pri bolnikih z mutacijami gBRCA1/2 in HER2-negativnim metastatskim rakom dojk so raziskali v randomiziranem, odprtem kontroliranem preskušanju III. faze (OlympiAD).
Ovarian cancer was the primary tumour in 86% of the patients.
Rak jajčnikov je bil primarni tumor pri 86 % bolnic.
• cyclosporine, sirolimus, tacrolimus - used to suppress the immune system
• ciklosporin, sirolimus, takrolimus - uporabljajo se za zaviranje imunskega sistema,
• Your doctor will tell you how many capsules of Lynparza to take.
• Zdravnik vam bo povedal, koliko kapsul zdravila Lynparza morate vzeti.
Iron oxide black (E172)
Črnilo šelak črni železov oksid (E172)
Adverse reactions that most commonly led to dose interruptions and/ or reductions were anaemia (13.9%), vomiting (7.1%), nausea (6.6%), fatigue/asthenia (6.1%) and neutropenia (5.8%).
Neželeni učinki, ki so najpogosteje povzročili prekinitev uporabe in/ali zmanjšanje odmerka, so bili anemija (13,9 %), bruhanje (7,1 %), navzea (6,6 %), utrujenost/astenija (6,1 %) in nevtropenija (5,8 %).
Patients could not have received prior olaparib or other PARP inhibitor treatment.
Bolnice predhodno niso smele dobivati olapariba ali drugih zaviralcev PARP.
Number of patients at risk Olaparib 300 mg twice daily tablet
Število izpostavljenih tveganju Olaparib 300 mg tableta dvakrat na dan
There are no data in patients with severe hepatic impairment (Child-Pugh classification C).
Podatkov pri bolnikih s hudo okvaro jeter ni (klasifikacija Child-Pugh C).
In vitro, olaparib has been shown to be an inhibitor of BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K.
In vitro je ugotovljeno, da olaparib zavira BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 in MATE2K.
Very common Decreased appetite
Presnovne in prehranske motnje zelo pogosti zmanjšanje apetita občasni zmanjšanje apetita
Secondary efficacy endpoints included time from randomisation to second progression or death (PFS2), overall survival (OS), time from randomisation to discontinuation of treatment or death (TDT), time from randomisation to first subsequent anticancer therapy or death (TFST) and health related quality of life (HRQoL).
Sekundarni opazovani dogodki učinkovitosti so obsegali čas od randomizacije do drugega napredovanja bolezni ali smrti (PFS2), celokupno preživetje (OS), čas od randomizacije do prenehanja zdravljenja ali smrti (TDT - time to discontinuation of treatment), čas od randomizacije do prvega nadaljnjega zdravljenja proti raku ali smrti (TFST - time to first subsequent therapy) in zdravstveno kakovost življenja (HRQoL - health related quality of life).
Therefore, known strong inducers of this isozyme (e.g. phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarbital and St John's Wort) are not recommended with Lynparza, as it is possible that the efficacy of Lynparza could be substantially reduced.
Zato zdravila Lynparza ni priporočljivo uporabljati z znanimi močnimi induktorji tega izoencima (npr. s fenitoinom, rifampicinom, rifapentinom, karbamazepinom, nevirapinom, fenobarbitalom in šentjanževko), ker obstaja možnost, da se učinkovitost zdravila Lynparza bistveno zmanjša.
Film-coated tablets 56 film-coated tablets
filmsko obložene tablete 56 filmsko obloženih tablet
If a patient develops severe haematological toxicity or blood transfusion dependence, treatment with Lynparza should be interrupted and appropriate haematological testing should be initiated.
Če se pri bolniku pojavijo hudi hematotoksični učinki ali je odvisen od transfuzij krvi, je treba zdravljenje z zdravilom Lynparza prekiniti in uvesti ustrezno hematološko testiranje.
• Tablet core: copovidone, silica colloidal anhydrous, mannitol, sodium stearyl fumarate.
• Jedro tablete: kopovidon, koloidni brezvodni silicijev dioksid, manitol, natrijev stearilfumarat.
The recommended dose of Lynparza is 400 mg (eight capsules) taken twice daily, equivalent to a total daily dose of 800 mg.
Priporočeni odmerek zdravila Lynparza je 400 mg (osem kapsul) dvakrat na dan; to ustreza celotnemu dnevnemu odmerku 800 mg.
Summary of key efficacy findings for patients with gBRCA1/2-mutated HER2negative metastatic breast cancer in OlympiAD
Povzetek ključnih izsledkov o učinkovitosti pri bolnikih s HER2-negativnim metastatskim rakom dojk z mutacijo gBRCA1/2 v OlympiAD
• Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow
• Obloga tablete: hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid
Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Pri bolnikih, ki imajo raka dojk s pozitivnimi hormonskimi receptorji (HR), je morala bolezen prav tako napredovati med predhodnim hormonskim zdravljenjem ali po njem, ali morajo bolniki veljati za neprimerne za hormonsko zdravljenje.
The study compared the efficacy of olaparib maintenance treatment taken until progression with no maintenance treatment in 265 (136 olaparib and 129 placebo) PSR serous ovarian cancer patients who were in response (CR [complete response] or PR [partial response]) confirmed as per RECIST and/or as per CA-125 criteria as defined by Gynecologic Cancer InterGroup (GCIG) (at least a 50% reduction in CA-125 levels from the last pre-treatment sample, confirmed 28 days later) following completion of two or more previous platinum-containing chemotherapy.
Študija je primerjala učinkovitost vzdrževalnega zdravljenja z olaparibom, uporabljanim do napredovanja, z neuporabo kakršnega koli vzdrževalnega zdravljenja pri 265 bolnicah (136 olaparib in 129 placebo) s PSR seroznim rakom jajčnikov, ki so bile v odzivu (popolnem odzivu [CR - complete response] ali delnem odzivu [PR - partial response]) potrjenem po merilih RECIST in/ali po kriterijih vrednosti CA-125, kot jih opredeljuje GCIG (Gynecologic Cancer InterGroup) (vsaj 50 % zmanjšanje koncentracije CA-125 od zadnje meritve na vzorcu pred zdravljenjem, potrjeno 28 dni pozneje), po dokončanju dveh ali več predhodnih kemoterapij na osnovi platine.
If a strong or moderate CYP3A inhibitor must be co-administered, the dose of Lynparza should be reduced (see sections 4.2 and 4.5).
Če je treba sočasno uporabiti močen ali zmeren zaviralec CYP3A, je treba odmerek zdravila Lynparza zmanjšati (glejte poglavji 4.2 in 4.5).
Among the patients entering the trial with measurable disease (target lesions at baseline), an objective response rate of 41% was achieved in the Lynparza arm versus 17% on placebo.
Med bolnicami, ki so vstopile v preizkušanje z merljivo boleznijo (ciljne lezije izhodiščno), je v skupini z zdravilom Lynparza doseglo objektivni delež odgovora 41 % bolnic in v skupini s placebom 17 % bolnic.
For patients with platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Pri bolnicah s ponovitvijo epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, je zdravljenje priporočljivo nadaljevati do napredovanja osnovne bolezni ali do nesprejemljive toksičnosti.
An exposure-response relationship between olaparib and decreases in haemoglobin has been demonstrated.
Med olaparibom in znižanjem hemoglobina je bilo dokazano razmerje izpostavljenosti in odziva.
Do not take Lynparza if any of the above apply to you.
Ne vzemite zdravila Lynparza, če navedeno velja za vas.
Lynparza co-administration with strong or moderate CYP3A inhibitors is not recommended (see section 4.5).
Sočasna uporaba zdravila Lynparza z močnimi ali zmernimi zaviralci CYP3A ni priporočljiva (glejte poglavje 4.5).
It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Uporabljamo ga potem, ko se je rak odzval na predhodno zdravljenje s standardno kemoterapijo na osnovi platine.
Lynparza is a white, opaque, hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Zdravilo Lynparza je bela, neprozorna trda kapsula z oznako "OLAPARIB 50 mg" in logom družbe AstraZeneca, natisnjenima s črnim črnilom.
Dose adjustments for co-administration with CYP3A inhibitors Concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternative agents should be considered.
Prilagoditve odmerka med sočasno uporabo zaviralcev CYP3A Sočasna uporaba močnih ali zmernih zaviralcev CYP3A ni priporočljiva in razmisliti je treba o drugih učinkovinah.
Patients whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled.
Vključene so bile bolnice, ki se jim je bolezen ponovila > 6 mesecev po dokončanju predzadnje kemoterapije na osnovi platine.
Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 400 mg twice daily.
Predklinične študije na podganah so pokazale, da ima olaparib neželene učinke na embrio-fetalno preživetje ter povzroča pomembne malformacije ploda pri izpostavljenostih, manjših od pričakovanih pri priporočenem odmerku za človeka 400 mg dvakrat na dan.
No unexpected adverse reactions were reported in a small number of patients who took a daily dose of up to 900 mg of olaparib tablets over two days.
Pri maloštevilnih bolnicah, ki so prejemale dnevni odmerek do 900 mg tablet olapariba v teku dveh dni, niso poročali o nepričakovanih neželenih učinkih.
In the olaparib arm 8% with measurable disease had a complete response versus 1.5% of patients in the comparator arm; 74/167 (44%) of patients in the olaparib arm had a partial response versus 14/66 (21%) of patients in the chemotherapy arm.
Popoln odziv je doseglo 8 % bolnikov v skupini z olaparibom in merljivo boleznijo ter 1,5 % v skupini s primerjalnim zdravilom; delen odziv je doseglo 74/167 (44 %) bolnikov v skupini z olaparibom in 14/66 (21 %) v skupini s kemoterapijo.
Important differences in posology between Lynparza tablets and capsules Lynparza tablets (100 mg and 150 mg) should not be substituted for Lynparza capsules (50 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Pomembne razlike v odmerjanju med tabletami in kapsulami zdravila Lynparza Tablet zdravila Lynparza (100 mg in 150 mg) se ne sme zamenjati s kapsulami zdravila Lynparza (50 mg) na podlagi miligrama za miligram, ker se odmerjanje in biološka uporabnost med eno in drugo obliko razlikujejo.
In Study 19, the incidence of anaemia was 22.8% (CTCAE grade ≥3 7.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 2.9%, 5.1% and 0%, respectively; 16.2% of patients treated with olaparib needed one or more blood transfusions during the treatment.
V Študiji 19 je bila pojavnost anemije 22,8 % (≥ 3. stopnje po CTCAE 7,4 %), pojavnost prekinitev uporabe 2,9 %, zmanjšanj odmerka 5,1 % in prenehanj uporabe 0 %; 16,2 % bolnic, ki so prejemale olaparib, je med zdravljenjem potrebovalo eno ali več transfuzij.
The analysis was performed using a Cox proportional hazards model including response to previous platinum chemotherapy (CR or PR) as a covariate.
Analiza je bila izvedena s Coxovim modelom sorazmernih ogroženosti, ki je kot sospremenljivko vključeval odziv (CR ali PR) na predhodno kemoterapijo na osnovi platine.
Breast-feeding during treatment and 1 month after the last dose (see section 4.6).
Dojenje med zdravljenjem in en mesec po zadnjem odmerku (glejte poglavje 4.6).
PARPs are required for the efficient repair of DNA single strand breaks and an important aspect of PARP-induced repair requires that after chromatin modification, PARP auto-modifies itself and dissociates from the DNA to facilitate access for base excision repair (BER) enzymes.
Pomemben vidik poprave s PARP zahteva, da se po modifikaciji kromatina PARP samospremeni in sprosti z DNA, da omogoči dostop encimom osnovnega popravljanja z izrezovanjem (BER - base excision repair).
White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Bela, neprozorna kapsula velikosti 0 z oznako "OLAPARIB 50 mg" in logom družbe AstraZeneca, natisnjenima s črnim črnilom.
In the placebo-treated group, 8.1% of patients remained on treatment for ≥2 years and 1.6% for ≥5 years.
V skupini, ki je prejemala placebo, je bil ta delež za ≥ 2 leti 8,1 % in za ≥ 5 let 1,6 %.
Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 300 mg twice daily.
Predklinične študije na podganah so pokazale, da ima olaparib neželene učinke na embrio-fetalno preživetje ter povzroča pomembne malformacije ploda pri izpostavljenostih, manjših od pričakovanih pri priporočenem odmerku za človeka 300 mg dvakrat na dan.
Tell your doctor straight away if you notice any of the following:
Če opazite kaj od naslednjega, nemudoma obvestite zdravnika:
In a post-hoc analysis of the subgroup of patients that had not progressed on chemotherapy other than platinum, the median PFS in the olaparib arm (n=22) was 8.3 months (95% CI 3.1-16.7) and 2.8 months (95% CI 1.4-4.2) in the chemotherapy arm (n=16) with a HR of 0.54 (95% CI 0.24-1.23).
V post-hoc analizi podskupin bolnikov, pri katerih bolezen ni napredovala med kemoterapijo brez platine, je bilo mediano PFS v skupini z olaparibom (n = 22) 8,3 meseca (95 % IZ: 3,1 do 16,7) in v skupini s kemoterapijo (n = 16) 2,8 meseca (95 % IZ: 1,4 do 4,2); ROg je bilo 0,54 (95 % IZ: 0,24 do 1,23).
There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST.
Za analize podskupin ter za vse bolnice s TFST ni bila uporabljena korekcija za večkratna testiranja.
Gender (%) Female Male
Spol (%)
In patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min), AUC increased by 44% and Cmax by 26% compared with patients with normal renal function.
Pri bolnicah z zmerno okvaro ledvic (očistek kreatinina 31 do 50 ml/min) je bila vrednost AUC povečana za 44 % in vrednost Cmax za 26 % v primerjavi z bolnicami z normalnim delovanjem ledvic.
When dosed orally to rats, olaparib induced micronuclei in bone marrow.
Peroralno uporabljeni olaparib je pri podganah povzročil pojav mikrojeder v kostnem mozgu.
Due to the effect of food on olaparib absorption, patients should take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards.
Hrana vpliva na absorpcijo olapariba, zato morajo bolnice zdravilo Lynparza vzeti vsaj eno uro po jedi ter po možnosti ne smejo jesti do 2 uri po uporabi zdravila.
In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2.
Podatki in vitro tudi kažejo, da olaparib ni substrat OATP1B1, OATP1B3, OCT1, BCRP ali MRP2 in ni zaviralec OATP1B3, OAT1 ali MRP2.
In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (elevations) from baseline in blood creatinine was approximately 10%.
V kliničnih študijah zdravila Lynparza je bila pojavnost sprememb (zvišanj) kreatinina v krvi ≥ 2. stopnje po CTCAE v primerjavi z izhodiščem približno 10 %.
Number of objective responders: Total number of patients with measurable disease (%)
Število bolnikov z objektivnim odzivom: celotno število bolnikov z merljivo boleznijo (%) 95% IZ
C-olaparib to female patients, unchanged olaparib accounted for the majority of the circulating radioactivity in plasma (70%) and was the major component found in both urine and faeces (15% and 6% of the dose, respectively).
C-olapariba pri bolnicah je šla večina radioaktivnosti v plazmi (70 %) na račun nespremenjenega olapariba, ki je bil tudi glavna snov v urinu in blatu (15 % odmerka v urinu in 6 % v blatu).
First-line maintenance treatment of BRCA-mutated advanced ovarian cancer: SOLO1 Study
Prva linija vzdrževalnega zdravljenja napredovalnega raka jajčnikov in mutacijo gena BRCA: Študija SOLO1
In replicating cells this also leads to the formation of DNA double-strand breaks (DSBs) when replication forks meet the PARP-DNA adducts.
V celicah, ki se razmnožujejo, to povzroči tudi nastanek dvoverižne prekinitve DNA (DSBs-double-strand breaks), ko podvojevalne vilice naletijo na adukt PARP-DNA.
It is not known whether Lynparza passes into semen.
Ni znano, ali zdravilo Lynparza prehaja v seme (spermo).
Lynparza can be administered to patients with mild or moderate hepatic impairment (Child-Pugh classification A or B) with no dose adjustment (see section 5.2).
Zdravilo Lynparza se lahko daje bolnikom z blago ali zmerno okvaro jeter (klasifikacija Child-Pugh A ali B) brez prilagoditve odmerka (glejte poglavje 5.2).
Demographic and baseline characteristics were generally well balanced between the olaparib and comparator arms (see Table 7).
Demografske in izhodiščne značilnosti so bile med skupino z olaparibom in skupino s primerjalnim zdravilom na splošno dobro uravnotežene (glejte preglednico 7).
• you have certain side effects while you are taking Lynparza (see section 4).
• če se vam med jemanjem zdravila Lynparza pojavijo določeni neželeni učinki (glejte poglavje 4).
If strong or moderate CYP3A inhibitors must be coadministered, the dose of Lynparza should be reduced.
Če je treba sočasno uporabiti močne ali zmerne zaviralce CYP3A, je treba odmerek zdravila Lynparza zmanjšati.
Ovarian cancer was the primary tumour in 85% of the patients.
Rak jajčnikov je bil primarni tumor pri 85 % bolnic.
• The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day - a total of 4 tablets each day.
• Običajni priporočeni odmerek je 300 mg (dve 150 mg tableti) dvakrat na dan - skupaj 4 tablete vsak dan.
Patients who have received two or more platinum-containing regimens and whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled.
Vključene so bile bolnice, ki so prejemale dve ali več shem s platino in se jim je bolezen ponovila > 6 mesecev po dokončanju predzadnje predhodne kemoterapije na osnovi platine.
Throw away any Lynparza capsules that have been frozen.
Kapsule zdravila Lynparza, ki so bile zamrznjene, morate zavreči.
95% CI
ROg a 95 % IZ
bd Twice daily; DCO Data cut off; FAS Full analysis set; OS Overall survival
DCO = datum zamejitve podatkov; FAS (full analysis set) = polni nabor za analizo
At 2 years, 43% olaparib-treated patients remained progression free compared with only 15% placebo-treated patients.
Po 2 letih je bilo brez napredovanja bolezni 43 % bolnic, zdravljenih z olaparibom, in le 15 % bolnic, ki so prejemale placebo.
In clinical studies with the tablet formulation, the incidence of anaemia adverse reactions was 38.8% (CTCAE grade ≥3 17.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 15.7%, 10.8% and 1.9%, respectively; 20.9% of patients treated with olaparib needed one or more blood transfusions.
V kliničnih študijah zdravila v obliki tablet je bila pojavnost neželenih učinkov anemije 38,8 % (≥ 3. stopnje po CTCAE 17,4 %), pojavnost prekinitev uporabe 15,7 %, zmanjšanj odmerka 10,8 % in prenehanj uporabe 1,9 %; 20,9 % bolnic, ki so prejemale olaparib, je med zdravljenjem potrebovalo eno ali več transfuzij.
Confirmed ORR - DCO 09 December 2016
Potrjeni ORR - DCO 09. december 2016
The most frequent adverse reactions leading to dose interruption or dose reduction were nausea, anaemia, vomiting, neutropenia and fatigue.
Najpogostejši neželeni učinki, ki so povzročili prekinitev uporabe ali zmanjšanje odmerka, so bili navzea, anemija, bruhanje, nevtropenija in utrujenost.
What Lynparza contains The active substance is olaparib.
Kaj vsebuje zdravilo Lynparza Učinkovina je olaparib.
The key efficacy findings from Study 19 for BRCA-mutated patients are presented in Table 2, and Figures 1 and 2.
Ključne izsledke o učinkovitosti iz študije 19 za bolnice z mutacijo gena BRCA prikazujejo preglednica 2 in sliki 1 in 2.
A statistically significant improvement in PFS, the primary efficacy outcome, was demonstrated for olaparib-treated patients compared with those in the comparator arm (see Table 8 and Figure 6).
Pri bolnikih, zdravljenih z olaparibom, je bilo preživetje brez napredovanja bolezni (ki je bilo primarni opazovani dogodek učinkovitosti) statistično značilno boljše kot pri bolnikih v primerjalni skupini (glejte preglednico 8 in sliko 6).
If MDS and/or AML are confirmed while on treatment with Lynparza, it is recommended that Lynparza should be discontinued and the patient be treated appropriately.
Če je med zdravljenjem z zdravilom Lynparza potrjen MSD in/ali AML, je priporočljivo uporabo zdravila Lynparza prekiniti in bolnike ustrezno zdraviti.
In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate).
V kliničnih študijah z zdravilom Lynparza je bila pojavnost sprememb (zmanjšanj) ≥ 2. stopnje po CTCAE od izhodišča za hemoglobin 20 %, absolutno število nevtrofilcev 20 %, trombocitov 5 %, limfocitov 30 % in levkocitov 20 % (vsi odstotki so približni).
The primary endpoint was PFS assessed by blinded independent central review (BICR) using RECIST 1.1.
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni, ocenjeno s slepljenim neodvisnim centralnim pregledom (BICR - blinded independent central review) in uporabo RECIST 1.1.
Tell your doctor, pharmacist or nurse if you are taking or are planning to take any of the following medicines:
Zdravniku, farmacevtu ali medicinski sestri morate povedati, če jemljete ali boste morda začeli jemati katero od naslednjih zdravil: