FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common ( 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti ( 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Median TSST (months)
Slovenian: Mediani TSST (meseci)
English: The primary endpoint was progression-free survival (PFS) defined as time from randomisation to progression determined by investigator assessment using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS), opredeljeno kot čas od randomizacije do napredovanja po raziskovalčevi oceni na podlagi modificiranih meril RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) ali do smrti.
English: Your doctor has prescribed Lynparza film-coated tablets for you.
Slovenian: Zdravnik vam je predpisal filmsko obložene tablete zdravila Lynparza.
English: Of the 94 patients on the placebo arm who received subsequent therapy, 49 (52%) received a PARP inhibitor.
Slovenian: Od 94 bolnic v skupini s placebom, ki so prejele nadaljnje zdravljenje, jih je 49 (52 %) prejelo zaviralec PARP.
English: Olaparib showed no mutagenic potential, but was clastogenic in mammalian cells in vitro.
Slovenian: Olaparib ni bil mutagen, se je pa izkazal za klastogenega v celicah sesalcev in vitro.
English: Patients were stratified by response to first-line platinum chemotherapy; complete response (CR) or partial response (PR).
Slovenian: Bolnice so stratificirali glede na odziv na kemoterapijo prve linije s platino; popoln odziv (CR - complete response) ali delen odziv (PR - partial response).
English: What you need to know before you take Lynparza
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lynparza
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX46
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX46
English: If you forget to take Lynparza, take your next normal dose at its scheduled time.
Slovenian: Če ste pozabili vzeti zdravilo Lynparza, vzemite naslednji normalni odmerek ob predvidenem času.
English: The active substance is olaparib.
Slovenian: Učinkovina je olaparib.
English: Median PFS (months)
Slovenian: Mediano PFS (meseci)
English: Pneumonitis, including events with a fatal outcome, has been reported in <1.0% of patients treated with Lynparza in clinical studies.
Slovenian: V kliničnih študijah je bil pnevmonitis, vključno s smrtnim izidom, opisan pri < 1,0 % bolnic, ki so bile zdravljene z zdravilom Lynparza.
English: Based on its mechanism of action (PARP inhibition), Lynparza could cause foetal harm when administered to a pregnant woman.
Slovenian: Glede na mehanizem delovanja (zavrtje PARP) zdravilo Lynparza lahko škoduje plodu, če se uporablja pri nosečnici.
English: The duration of therapy with olaparib in patients who developed MDS/AML varied from <6 months to >2 years; data with longer durations of exposure are limited.
Slovenian: Pri bolnicah, ki so zbolele za MDS/AML, je zdravljenje z olaparibom trajalo od < 6 mesecev do > 2 leti; podatkov o dolgotrajnejši izpostavljenosti je malo.
English: * (2-sided)
Slovenian: (2-stranska)
English: It cannot be excluded that olaparib may increase the exposure to substrates of BCRP (e.g. methotrexate, rosuvastatin), OATP1B1 (e.g. bosentan, glibenclamide, repaglinide, statins and valsartan), OCT1 (e.g. metformin), OCT2 (e.g. serum creatinine), OAT3 (e.g. furosemide and methotrexate), MATE1 (e.g. metformin) and MATE2K (e.g. metformin).
Slovenian: Ni mogoče izključiti možnosti, da olaparib poveča izpostavljenost BCRP (npr. metotreksatu, rosuvastatinu), OATP1B1 (npr. bosentanu, glibenklamidu, repaglinidu, statinom in valsartanu), OCT1 (npr. metforminu), OCT2 (npr. kreatininu v serumu), OAT3 (npr. furosemidu in metotreksatu), MATE1 (npr. metforminu) in MATE2K (npr. metforminu).
English: All patients had potential contributing factors for the development of MDS/AML; having received previous chemotherapy with platinum agents.
Slovenian: Vse bolnice so imele dejavnike, ki so lahko pripomogli k pojavu MDS/AML; predhodno so prejemale kemoterapijo z zdravili s platino.
English: • pimozide, quetiapine - used to treat mental health problems
Slovenian: • pimozid, kvetiapin - uporabljata se za zdravljenje težav z duševnim zdravjem,
English: Some of the patients had a history of previous cancer or of bone marrow dysplasia.
Slovenian: Nekatere bolnice so imele anamnezo predhodnega raka ali displazijo kostnega mozga.
English: Lynparza 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.
Slovenian: Zdravilo Lynparza se sme pri bolnikih s hudo okvaro ledvic uporabiti le, če koristi odtehtajo možna tveganja; bolnikom je potrebno skrbno spremljati delovanje ledvic in neželene dogodke.
English: • digoxin, diltiazem, furosemide, verapamil, valsartan - used to treat heart conditions or high blood pressure
Slovenian: • digoksin, diltiazem, furosemid, verapamil, valsartan - uporabljajo se za zdravljenje bolezni srca ali visokega krvnega tlaka,
English: • low white blood cell count (leukopenia or neutropenia) which may decrease your ability to fight infection and may be associated with fever.
Slovenian: • majhno število belih krvnih celic v krvi (levkopenija, nevtropenija), zaradi česar se lahko zmanjša vaša sposobnost za premagovanje okužb in je lahko povezano z vročino.
English: Symptoms of overdose are not established and there is no specific treatment in the event of Lynparza overdose.
Slovenian: Simptomi prevelikega odmerjanja niso ugotovljeni zato specifičnega zdravljenja za preveliko odmerjanje zdravila Lynparza ni.
English: If the blood parameters remain clinically abnormal after 4 weeks of Lynparza dose interruption, bone marrow analysis and/or blood cytogenetic analysis are recommended.
Slovenian: Če krvne vrednosti ostanejo klinično nenormalne še 4 tedne po prekinitvi uporabe zdravila Lynparza, je priporočljivo opraviti preiskavo kostnega mozga in/ali krvno citogenetsko analizo.
English: This is because Lynparza can affect the way some other medicines work.
Slovenian: Zdravilo Lynparza namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: Reports of pneumonitis had no consistent clinical pattern and were confounded by a number of pre-disposing factors (cancer and/or metastases in lungs, underlying pulmonary disease, smoking history, and/or previous chemotherapy and radiotherapy).
Slovenian: Opisani primeri pnevmonitisa niso imeli konsistentnega kliničnega vzorca in so jih spremljali številni predispozicijski dejavniki (rak in/ali metastaze v pljučih, osnovna bolezen pljuč, anamneza kajenja in/ali predhodna kemoterapija ali radioterapija).
English: • methotrexate - used to treat cancer, rheumatoid arthritis and psoriasis.
Slovenian: • metotreksat - uporablja se za zdravljenje raka, revmatoidnega artritisa in luskavice.
English: TFST (58% maturity) Number of events: Total number of patients (%)
Slovenian: TFST (~58 % zrelost) Število dogodkov: skupno število bolnic (%)
English: In solutions of purified proteins, the olaparib fraction bound to albumin was approximately 56%, which was independent of olaparib concentrations.
Slovenian: V raztopinah prečiščenih beljakovin je bil na albumin vezani delež olapariba približno 56 % in ni bil odvisen od koncentracije olapariba.
English: PFS2 (40% maturity) Number of events: Total number of patients (%)
Slovenian: PFS2 (~40 % zrelost) Število dogodkov: skupno število bolnic (%)
English: • at regular intervals decided by your doctor after the first year of treatment.
Slovenian: • po prvem letu zdravljenja pa v rednih presledkih, ki jih bo določil zdravnik.
English: Appropriate clinical monitoring is recommended for patients receiving this type of medicinal product concomitantly.
Slovenian: Bolnike, ki sočasno prejemajo to vrsto zdravil, je priporočljivo ustrezno klinično spremljati.
English: OUTER CARTON MULTIPACK -including the blue box
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA - z modrim okencem
English: • bosentan - used to treat pulmonary artery hypertension
Slovenian: • bosentan - uporablja se za zdravljenje pljučne arterijske hipertenzije,
English: In the event that a patient already receiving Lynparza requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of Lynparza may be substantially reduced (see section 4.5).
Slovenian: Če bolnik, ki že prejema zdravilo Lynparza, potrebuje zdravljenje z močnim ali zmernim induktorjem CYP3A, se mora zdravnik, ki predpisuje zdravilo, zavedati, da se lahko učinkovitost zdravila Lynparza bistveno zmanjša (glejte poglavje 4.5).
English: A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis).
Slovenian: Pri maloštevilnih bolnicah, ki so jemale zdravilo Lynparza, se je pojavilo vnetje pljuč (pnevmonitis).
English: • you are taking certain medicines that may affect Lynparza (see section 2).
Slovenian: • če jemljete določena zdravila, ki lahko vplivajo na delovanje zdravila Lynparza (glejte poglavje 2),
English: Common side effects that may show up in blood tests:
Slovenian: Pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
English: Exploratory analyses of time to first subsequent therapy or death (TFST) and time to second subsequent therapy or death (TSST- an approximation of PFS2) were also performed.
Slovenian: Opravljeni sta bili tudi eksploratorni analizi časa do prvega nadaljnjega zdravljenja ali smrti (TFST - time to first subsequent therapy or death) in časa do drugega nadaljnjega zdravljenja ali smrti (TSST - time to second subsequent therapy or death), ki je približek PFS2.
English: When olaparib is bound to the active site of DNA-associated PARP it prevents the dissociation of PARP and traps it on the DNA, thus blocking repair.
Slovenian: Če je olaparib vezan na aktivno mesto z DNA povezane PARP, prepreči sprostitev PARP in jo ohrani vezano na DNA ter tako onemogoči popravilo.
English: In vitro, CYP3A4/5 were shown to be the enzymes primarily responsible for the metabolism of olaparib (see section 4.5).
Slovenian: In vitro je dokazano, da so CYP3A4/5 encimi, ki so predvsem odgovorni za presnovo olapariba (glejte poglavje 4.5).
English: Of patients treated with Lynparza, who entered the study with evidence of disease (target or non-target lesions at baseline), 15.0% experienced complete response compared with 9.1% of patients on placebo.
Slovenian: Med bolnicami, ki so prejemale zdravilo Lynparza in so v študijo vstopile z znaki bolezni (ciljne ali neciljne lezije izhodiščno), jih je popoln odziv doseglo 15,0 %, s placebom pa 9,1 %.
English: Both nausea and vomiting were reported to be intermittent for the majority of patients and can be managed by dose interruption, dose reduction and/or antiemetic therapy.
Slovenian: Navzea in bruhanje sta bila pri večini bolnic intermitentna in ju je mogoče obvladati s prekinitvijo uporabe, zmanjšanjem odmerka in/ali uporabo antiemetikov.
English: Embryofoetal toxicity
Slovenian: Embrio-fetalna toksičnost
English: Genetic counselling for patients tested for mutations in BRCA1/2 genes should be performed according to local regulations.
Slovenian: Genetsko svetovanje bolnikom, testiranim za prisotnost mutacij v genih BRCA1/2, je treba opraviti v skladu z lokalnimi predpisi.
English: Therefore, it is recommended that patients take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards (see section 4.2).
Slovenian: Zato je priporočljivo, da bolnice jemljejo zdravilo Lynparza vsaj eno uro po jedi ter po možnosti ne smejo jesti do 2 uri po uporabi zdravila (glejte poglavje 4.2).
English: In a female fertility study where rats were dosed until implantation, although extended oestrus was observed in some animals, mating performance and pregnancy rate was not affected.
Slovenian: V študiji plodnosti pri samicah, v kateri so podgane dobivale zdravilo do implantacije, so pri nekaterih živalih sicer opažali podaljšan estrus, a sposobnost parjenja in delež brejosti nista bila prizadeta.
English: The incidence of elevations in mean corpuscular volume from low or normal at baseline to above the ULN was approximately 55%.
Slovenian: Pojavnost povečanj povprečnega volumna eritrocitov (MCV) od majhnega ali normalnega izhodiščno do MCV nad ZNM je bila približno 55 %.
English: • phenytoin, carbamazepine, phenobarbital - used as a sedative or to treat fits (seizures) and epilepsy
Slovenian: • fenitoin, karbamazepin, fenobarbital - uporabljajo se kot pomirjevala ali za zdravljenje napadov krčev (epileptičnih napadov) in epilepsije,
English: Studies using human bone marrow cells also showed that direct exposure to olaparib can result in toxicity to bone marrow cells in ex vivo assays.
Slovenian: Študije, v katerih so uporabili celice humanega kostnega mozga so tudi dokazale, da je ob neposredni izpostavljenosti celic kostnega mozga olaparibu v ex vivo poskusih lahko le ta zanje toksičen.
English: Lynparza is for oral use.
Slovenian: Zdravilo Lynparza je za peroralno uporabo.
English: • ovarian cancer that has come back (recurred).
Slovenian: • raka jajčnikov, ki se je ponovil.
English: Baseline testing, followed by monthly monitoring of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment which may require dose interruption or reduction and/or further treatment (see sections 4.2 and 4.4).
Slovenian: Preiskava celotne krvne slike je priporočljiva na začetku zdravljenja, potem vsak mesec prvih 12 mesecev zdravljenja in pozneje redno, da bi med zdravljenjem odkrili klinično pomembne spremembe katere koli vrednosti, ki bi zahtevala prekinitev ali zmanjšanje odmerka in/ali dodatno zdravljenje (glejte poglavji 4.2 in 4.4).
English: C-olaparib, ~86% of the dosed radioactivity was recovered within a 7-day collection period, ~44% via the urine and ~42% via the faeces.
Slovenian: C-olapariba se je v 7 dneh zbiranja izločilo ~86 % radioaktivnega odmerka, ~44 % v urinu in ~42 % v blatu.
English: 56 film-coated tablets (7 blisters).
Slovenian: 56 filmsko obloženih tablet (7 pretisnih omotov).
English: Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or 2), however, there were reports of CTCAE grade 3 and higher events.
Slovenian: Anemija in drugi hematotoksični učinki so bili na splošno nizke stopnje (1 ali 2 po CTCAE), vendar so bili opisani tudi dogodki stopnje 3 ali več po CTCAE.
English: Studies in animals have shown reproductive toxicity including serious teratogenic effects and effects on embryofoetal survival in the rat at maternal systemic exposures lower than those in humans at therapeutic doses (see section 5.3).
Slovenian: Študije na živalih so pri podganah pokazale vpliv na sposobnost razmnoževanja, vključno z resnimi teratogenimi učinki in vplivom na embrio-fetalno preživetje pri sistemskih izpostavljenostih samicmater, manjših od izpostavljenosti pri človeku v terapevtskih odmerkih (glejte poglavje 5.3).
English: In population based PK analyses, patient age, gender, bodyweight or race (including White and Japanese patients) were not significant covariates.
Slovenian: V populacijski farmakokinetični analizi starost bolnikov, spol, telesna masa ali rasa (vključno z bolniki belci in japonskimi bolniki) niso bile pomembne sospremenljivke.
English: In vitro, human plasma protein binding of olaparib was dose-dependent; the fraction bound was approximately 91% at 1 µg/mL, reducing to 82% at 10 µg/mL and to 70% at 40 µg/mL.
Slovenian: In vitro je bila vezava olapariba na beljakovine v humani plazmi odvisna od odmerka; vezani delež je bil pri koncentraciji 1 µg/ml približno 91 % in se je pri koncentraciji 10 µg/ml zmanjšal na 82 % in pri koncentraciji 40 µg/ml na 70 %.
English: • Your doctor will tell you how many tablets of Lynparza to take.
Slovenian: • Zdravnik vam bo povedal, koliko tablet zdravila Lynparza morate vzeti.
English: Large rearrangements in the BRCA1/2 genes were detected in 7.4% (10/136) of the randomised patients.
Slovenian: Velike preureditve genov BRCA1/2 so ugotovili pri 7,4 % (10/136) randomiziranih bolnic.
English: Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).
Slovenian: Olaparib je vrsta zdravila proti raku, ki jih imenujemo zaviralci PARP (zaviralec poli [adenozin-difosfat-riboza] polimeraze).
English: • Swallow Lynparza tablets whole, with or without food.
Slovenian: • Tablete zdravila Lynparza morate pogoltniti cele, s hrano ali brez nje.
English: • telithromycin, clarithromycin, erythromycin - used for bacterial infections
Slovenian: • telitromicin, klaritromicin, eritromicin - uporabljajo se za zdravljenje bakterijskih okužb,
English: Number of events: Total number of patients (%)
Slovenian: Število dogodkov: celotno število bolnikov (%)
English: Female patients:
Slovenian: Ženske bolnice:
English: Ovarian cancer was the primary tumour in >80% of the patients.
Slovenian: Rak jajčnikov je bil primarni tumor pri > 80 % bolnic.
English: Co-administration with food slowed the rate (tmax delayed by 2.5 hours and Cmax reduced by approximately 21%) but did not significantly affect the extent of absorption of olaparib (AUC increased 8%).
Slovenian: Sočasna uporaba s hrano je upočasnila hitrost absorpcije (podaljšanje tmax za 2,5 ure in zmanjšanje vrednosti Cmax za približno 21 %), ni pa bistveno vplivala na obseg absorpcije olapariba (povečanje vrednosti AUC za 8 %).
English: OS analysis in patients with no prior chemotherapy for metastatic breast cancer indicated benefit in these patients with a HR of 0.45 (95% CI 0.27-0.77), while for further lines of therapy HR exceeded 1.
Slovenian: Analiza celokupnega preživetja pri bolnikih brez predhodne kemoterapije za metastatskega raka dojk je pri teh bolnikih pokazala korist z ROg 0,45 (95 % IZ: 0,27 do 0,77), medtem ko je pri nadaljnjih linijah zdravljenja ROg presegalo 1.
English: All patients had received first-line platinum-based therapy.
Slovenian: Vse bolnice so prejele zdravljenje prve linije na osnovi platine.
English: Following oral administration of olaparib via the capsule formulation, absorption is rapid with peak plasma concentrations typically achieved between 1 to 3 hours after dosing.
Slovenian: Po peroralni uporabi olapariba v kapsulah je absorpcija hitra in največja koncentracija v plazmi je praviloma dosežena od 1 do 3 ure po uporabi.
English: Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients.
Slovenian: Primeri navzee so vodili do prekinitve uporabe pri 14 % in zmanjšanja odmerka pri 4 % bolnic, zdravljenih z olaparibom.
English: It is not known whether olaparib or its metabolites are found in seminal fluid.
Slovenian: Ni znano, ali se olaparib ali njegovi presnovki pojavijo v semenski tekočini.
English: The Grade ≥ 3 adverse reactions occurring in > 2% of patients were anaemia (16%), neutropenia (6%), fatigue/asthenia (6%), leukopenia (3%), thrombocytopenia (2%) and vomiting (2%).
Slovenian: Neželeni učinki ≥ 3. stopnje, ki so se pojavili pri > 2 % bolnic so bili anemija (16 %), nevtropenija (6 %), utrujenost/astenija (6 %), levkopenija (3 %), trombocitopenija (2 %) in bruhanje (2 %).
English: Lynparza is used for the treatment of a type of ovarian cancer called “BRCA-mutated ovarian cancer”.
Slovenian: Zdravilo Lynparza uporabljamo za zdravljenje raka jajčnikov, imenovanega "rak jajčnikov z mutiranim genom BRCA".
English: • Capsule content: lauroyl macrogol-32 glycerides.
Slovenian: • Vsebina kapsule: makrogolglicerol lavrat-32.
English: After a number of rounds of replication, genomic instability can reach insupportable levels and result in cancer cell death, as cancer cells already have a high DNA damage load relative to normal cells.
Slovenian: Po številnih ponovitvah replikacije lahko genomska nestabilnost doseže nevzdržno raven in povzroči odmrtje rakave celice, ker rakave celice že imajo veliko okvar DNA v primerjavi z normalnimi.
English: • Taking the wrong dose or a tablet instead of a capsule could lead to Lynparza not working properly or to more side effects.
Slovenian: • Če vzamete napačen odmerek ali če vzamete tableto namesto kapsule, to lahko povzroči, da zdravilo Lynparza ne bo delovalo pravilno ali da bo imelo več neželenih učinkov.
English: Genetic counselling for patients with BRCA1/2 mutations should be performed according to local regulations.
Slovenian: Genetsko svetovanje bolnicam z mutacijami gena BRCA1/2 je treba opraviti v skladu z lokalnimi predpisi.
English: This medicinal product contains 0.24 mg sodium per 100 mg tablet and 0.35 mg sodium per 150 mg tablet, i.e. essentially “sodium-free”.
Slovenian: To zdravilo vsebuje 0,24 mg natrija na 100 mg tableto in 0,35 mg natrija na 150 mg tableto, kar v bistvu pomeni ‘brez natrija'.
English: Uncommon Hypersensitivity a, Dermatitis
Slovenian: Bolezni imunskega sistema pogosti izpuščaj občasni preobčutljivost a, dermatitis
English: Induction of CYP1A2, 2B6 and 3A4 has been shown in vitro with CYP2B6 being most likely to be induced to a clinically relevant extent.
Slovenian: In vitro so ugotovili indukcijo CYP1A2, 2B6 in 3A4; klinično pomembna indukcija je najverjetnejša pri CYP2B6.
English: Table 3 Summary of progression-free survival and overall survival: sBRCA mutated population in Study 19
Slovenian: Povzetek preživetja brez napredovanja bolezni in celokupnega preživetja: populacija z mutacijo gena sBRCA v študiji 19
English: The median follow-up time in censored patients was 25.3 months for olaparib versus 26.3 months for comparator.
Slovenian: Mediani čas spremljanja pri krnjenih bolnikih je bil 25,3 meseca v skupini z olaparibom in 26,3 meseca v skupini s primerjalnim zdravilom.
English: Using the same assay, the fraction bound to alpha-1 acid glycoprotein was 29% at 10 µg/mL with a trend of decreased binding at higher concentrations.
Slovenian: Z uporabo istega preskusa je bil na alfa-1 kisli glikoprotein vezani delež ob koncentraciji 10 µg/ml 29 % in opazen je bil trend zmanjševanja vezave pri večjih koncentracijah.
English: TFST (49% maturity)
Slovenian: TFST (49 % zrelost)
English: • itraconazole, fluconazole - used for fungal infections
Slovenian: • itrakonazol, flukonazol - uporabljata se za zdravljenje glivičnih okužb,
English: In vitro, olaparib is a substrate of the efflux transporter P-gp, however, this is unlikely to be of clinical significance (see section 4.5).
Slovenian: In vitro je olaparib substrat iztočnega prenašalca P-gp, vendar ni verjetno, da bi bilo to klinično pomembno (glejte poglavje 4.5).
English: • Taking the wrong dose or a capsule instead of a tablet could lead to Lynparza not working properly or to more side effects.
Slovenian: • Če vzamete napačen odmerek ali če vzamete kapsulo namesto tablete, to lahko povzroči, da zdravilo Lynparza ne bo delovalo pravilno ali da bo imelo več neželenih učinkov.
English: In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically.
Slovenian: V primeru prevelikega odmerjanja je treba uporabiti splošne podporne ukrepe in bolnike simptomatsko zdraviti.
English: There are no efficacy or safety data on maintenance retreatment with Lynparza following first or subsequent relapse in ovarian cancer patients or on retreatment of breast cancer patients (see section 5.1).
Slovenian: Podatkov o učinkovitosti ali varnosti za ponovno vzdrževalno zdravljenje z zdravilom Lynparza po prvi ali poznejši ponovitvi bolezni pri bolnicah z rakom jajčnikov ali za ponovno zdravljenje bolnikov z rakom dojk ni (glejte poglavje 5.1).