FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Slovenian: Pogostnost reakcij, povezanih z infuzijo, vseh stopenj je bila različna po študijah glede na indikacijo, metodologijo zbiranja podatkov in glede na to, ali so dajali trastuzumab sočasno s kemoterapijo ali v monoterapiji.
English: A vial of Ontruzant reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Slovenian: Viala zdravila Ontruzant, rekonstituirana z vodo za injekcije (ni priložena), je stabilna 48 ur pri 2 ºC8 ºC po rekonstituciji in je ne smete zamrzniti.
English: On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za trastuzumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo trastuzumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Ontruzant is given as an infusion into a vein (intravenous infusion, “drip”).
Slovenian: Zdravilo Ontruzant se daje kot infuzija v veno (intravenska infuzija, kapalna infuzija).
English: All the terms included are based on the highest percentage seen in pivotal clinical trials.
Slovenian: Pri vseh navedenih neželenih učinkih je upoštevan najvišji odstotek, ugotovljen v ključnih kliničnih preskušanjih.
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Slovenian: 1 Označuje neželene učinke, o katerih so večinoma poročali v povezavi z reakcijami, povezanimi z infuzijo.
English: The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects (see section 2 under “Warnings and precautions”).
Slovenian: Prvi odmerek zdravila boste prejemali 90 minut, med prejemanjem pa vas bo zaradi možnosti pojava neželenih učinkov, opazoval zdravstveni delavec (glejte poglavje 2 pod “Opozorila in previdnostni ukrepi”).
English: • You should use effective contraception during treatment with Ontruzant and for at least 7 months after treatment has ended.
Slovenian: • Med zdravljenjem z zdravilom Ontruzant in še vsaj 7 mesecev po končanju zdravljenja morate uporabljati učinkovito kontracepcijo.
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Slovenian: Podatki kažejo, da je bilo več koristnih učinkov pri bolnikih z višjo stopnjo čezmernega izražanja HER2 (3+).
English: Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
Slovenian: Zgodnji rak dojk je definiran kot primarni invazivni karcinom dojk brez metastaz.
English: Contents of the pack and other information What Ontruzant contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ontruzant
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
Slovenian: V zelo redkih primerih so se pri bolnikih pojavili simptomi reakcije na infuzijo in simptomi, povezani s pljuči, več kot šest ur po začetku infuzije trastuzumaba.
English: Trastuzumab 1 Year N=1693
Slovenian: Trastuzumab 1 leto N = 1693
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Slovenian: V ključnem preskušanju docetaksela (100 mg/m2, infundiranih v času 1 ure) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na podlagi antraciklinov.
English: +Cardiac failure (congestive)
Slovenian: +popuščanje srca (kongestivno)
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Slovenian: Spremljanje lahko olajša prepoznati bolnike, pri katerih se pojavijo motnje v delovanju srca.
English: Ontruzant is for single-use only, as the product contains no preservatives.
Slovenian: Zdravilo Ontruzant je samo za enkratno uporabo, ker ne vsebuje konservansov.
English: Some of these side effects may be serious and may lead to hospitalisation.
Slovenian: Nekateri od teh neželenih učinkov so lahko resni in bo morda potrebno zdravljenje v bolnišnici.
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Slovenian: Trastuzumab je tudi močan mediator od protiteles odvisne celične citotoksičnosti (antibody-dependent cell-mediated cytotoxicityADCC).
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Slovenian: Rezultati učinkovitosti iz preskušanja BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6:
English: • You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
Slovenian: • imate metastatskega raka dojk (raka dojk, ki se je razširil še na druga mesta zunaj prvotnega tumorja) z visoko ravnijo HER2.
English: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Slovenian: po operaciji, kemoterapiji (neoadjuvantni ali adjuvantni) in radioterapiji (če je primerno) (glejte poglavje 5.1);
English: For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Slovenian: Glede vseh drugih metod, ki bi se uporabljale za določanje beljakovine ali izražanja gena HER2, smejo analize opravljati le laboratoriji, ki uporabljajo ustrezne sodobne validirane metode.
English: Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Slovenian: Podrobnejših farmakokinetičnih študij pri starejših in tistih z ledvično ali jetrno okvaro niso opravili.
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Slovenian: Izhodiščne ravni HER2-ECD v krvi, ki so jih ugotovili pri bolnikih z MGC, so bile primerljive s tistimi pri bolnikih z MBC in EBC, očitnega vpliva na očistek trastuzumaba niso ugotovili.
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Slovenian: Do časa analize je umrlo skupaj 349 randomiziranih bolnikov: 182 bolnikov (62,8 %) v kontrolni skupini in 167 bolnikov
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Slovenian: Pogostnost je bila največja pri bolnikih, ki so prejeli trastuzumab sočasno s taksanom (2,0 %).
English: A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Slovenian: Volumski presežek 4 % zagotavlja, da lahko iz vsake viale odvzamete označeni odmerek 150 mg.
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Slovenian: Dodatek trastuzumaba kemoterapiji s paklitakselom je povzročil tudi 37-odstotno zmanjšanje tveganja smrti.
English: This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Slovenian: Ta intravenska oblika zdravila ni namenjena za subkutano uporabo in se sme dajati samo kot intravenska infuzija.
English: The majority of patients experienced resolution of symptoms and subsequently received further infusions of trastuzumab.
Slovenian: Pri večini bolnikov so simptomi izzveneli in so bolniki nato prejeli nadaljnje infuzije trastuzumaba.
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Slovenian: V študijo so vključili bolnike z na novo diagnosticiranim lokalno napredovalim (stadij III) ali vnetnim zgodnjim rakom dojk.
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Slovenian: Previdnost je potrebna tudi pri zdravljenju bolnikov z zvečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF < 55 %, starejših bolnikih.
English: 1Blood pressure increased
Slovenian: 1zvišan krvni tlak
English: Ontruzant may have a minor influence on the ability to drive or use machines (see section 4.8).
Slovenian: Zdravilo Ontruzant ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Slovenian: Lahko se zdravijo z analgetikom/antipiretikom, kot je meperidin (petidin) ali paracetamol, ali antihistaminikom, kot je difenhidramin.
English: The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Slovenian: Učinkovitosti trastuzumaba v kombinaciji s paklitakselom pri bolnikih, ki niso predhodno prejeli adjuvantnih antraciklinov, niso proučevali.
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in fetal death.
Slovenian: To stanje lahko škoduje otroku v maternici in ga povezujejo z nedozorelostjo pljuč, kar lahko povzroči smrt ploda.
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
Slovenian: Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi trastuzumaba v nosečnosti izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
English: Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Slovenian: Trastuzumab so raziskovali v randomiziranem, odprtem preskušanju 3. faze ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
English: For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Slovenian: Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celotnem odzivu (16,5 % proti 6,7 %); pogostnosti klinične koristi (42,7 % proti 27,9 %) in času do napredovanja bolezni (4,8 meseca proti 2,4 meseca).
English: A volume overage of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Slovenian: Volumski presežek 5 % zagotavlja, da lahko iz vsake viale odvzamete označeni odmerek 420 mg.
English: The efficacy results from Study MO16432 are summarized in Table 12.
Slovenian: Rezultati učinkovitosti iz študije MO16432 so povzeti v preglednici 12.
English: These are very common (may affect more than 1 in 10 people).
Slovenian: Ti so zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov).
English: (day)
Slovenian: (dni)
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6-8 weeks).
Slovenian: Za bolnike z asimptomatičnimi motnjami v delovanju srca je koristen pogostejši nadzor (npr. vsakih 6 do 8 tednov).
English: Docetaxel3 N=94
Slovenian: Docetaksel3 N = 94
English: If you experience any of the above symptoms when your treatment with Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant.
Slovenian: Če se kateri koli od zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Ontruzant, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Ontruzant.
English: The efficacy results from study BO18225 are summarized in Table 13:
Slovenian: Rezultati učinkovitosti iz študije BO18225 so povzeti v preglednici 13:
English: • insomnia (inability to sleep)
Slovenian: • nespečnost (nezmožnost spati),
English: To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Slovenian: Da bodo zagotovljeni validacija postopkov testiranja in natančni in reproducibilni rezultati testiranja, mora testiranje HER2 opravljati laboratorij, v katerem je zaposleno kvalificirano osebje.
English: 2) Swirl the vial gently to aid reconstitution.
Slovenian: 2) Nežno vrtite vialo, da pospešite rekonstitucijo.
English: If you receive Ontruzant with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Slovenian: Če prejemate zdravilo Ontruzant z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo, ki so priložena tem zdravilom.
English: Like all medicines, Ontruzant can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Ontruzant neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Do not use Ontruzant if you notice any particulate matter or discoloration prior to administration.
Slovenian: Ne uporabljajte zdravila Ontruzant, če pred uporabo opazite kakšne delce ali obarvanost.
English: Study H0649g: IHC3+ patient subset
Slovenian: Študija H0649g: podskupina bolnikov z IHC3+
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Slovenian: Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1-year trastuzumab treatment is associated with a 24% risk reduction compared to observation only (HR=0.76, 95% CI 0.67, 0.86).
Slovenian: Končna analiza, ki so jo opravili po medianem spremljanju 8 let, je pokazala, da je enoletno zdravljenje s trastuzumabom povezano s 24-odstotnim zmanjšanjem tveganja v primerjavi samo z opazovanjem (HR = 0,76, 95 % IZ 0,67, 0,86).
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ontruzant (trastuzumab) and not trastuzumab emtansine.
Slovenian: Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Ontruzant (trastuzumab) in ne trastuzumab emtanzin.
English: Study H0648g: IHC3+ patient subset
Slovenian: Študija H0648g: podskupina bolnikov z IHC3+
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Slovenian: • imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-flououracilom in cisplatinom.
English: If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Slovenian: Če bolnika zdravimo z antraciklini, je treba skrbno spremljati delovanje srca.
English: • blood infection
Slovenian: • okužba krvi.
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na trastuzumab, murine (mišje) beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Slovenian: Čeprav so ob uporabi Cairo-Bishopovih meril za diagnozo prisotne nekatere omejitve, ki vodijo v podcenitev števila primerov, je smiselna posodobitev Informacij o zdravilu, v katere je treba vključiti sindrom razpada tumorja z neznano pogostnostjo, ker je trastuzumab močan mediator citotoksičnosti, povzročene s celicami, odvisnimi od protiteles (antibody-dependent cell-mediated cytotoxicity ADCC).
English: The reconstituted Ontruzant results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Slovenian: Rekonstituirano zdravilo Ontruzant je brezbarvna do rahlo rumena prozorna tekočina in mora biti praviloma brez vidnih delcev.
English: Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Slovenian: Pri bolnikih, zdravljenih s trastuzumabom, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association [NYHA], razred II-IV) ali asimptomatične motnje v delovanju srca.
English: During an Ontruzant infusion, chills, fever and other flu like symptoms may occur.
Slovenian: Med infuzijo zdravila Ontruzant se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
English: FP +H N=294 HR (95% CI)
Slovenian: FP +H N = 294 HR (95 % IZ) vrednost p
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH.
Slovenian: Študije pogostnosti pozitivnosti HER2 pri raku želodca (RŽ) z imunohistokemijo (immunohistochemistry - IHC) in fluorescenčno hibridizacijo in situ (fluorescence in situ hybridization - FISH) ali kromogeno hibridizacijo in situ (chromogenic in situ hybridization - CISH) so pokazale, da se pozitivnost HER2 razlikuje v širokem obsegu, ki sega od 6,8 % do 34,0 % pri IHC in 7,1 % do 42,6 % pri FISH.
English: Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Slovenian: Med najresnejšimi in/ali pogostimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Ontruzant, so motnje v delovanju srca, reakcije, povezane z infuzijo, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) >25 kg/m2.
Slovenian: Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z večjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba, in velikim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
English: Duration of response, median months
Slovenian: Trajanje odziva, mediano število mesecev
English: The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Slovenian: Tveganje za nevtropenijo se lahko rahlo zveča, kadar dajemo trastuzumab z docetakselom po antraciklinski terapiji.
English: Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Slovenian: Dejavniki tveganja, povezani z intersticijsko boleznijo pljuč, vključujejo predhodno ali sočasno zdravljenje z drugimi načini zdravljenja raka, za katere je znano, da so z njo povezani, na primer s taksani, gemcitabinom, vinorelbinom in zdravljenje z obsevanjem.
English: Overall response rate,%
Slovenian: mediano število mesecev Celotna odzivnost, %
English: Other side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
Slovenian: Drugi neželeni učinki lahko nastopijo kadar koli med zdravljenjem z zdravilom Ontruzant in niso povezani le z infuzijo.
English: The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
English: in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1).
Slovenian: v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom Ontruzant, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
English: • altered taste
Slovenian: • spremenjeno okušanje,
English: Only patients with a large amount of HER2 will be treated with Ontruzant.
Slovenian: Z zdravilom Ontruzant bodo zdravili samo bolnike z veliko količino HER2.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Slovenian: Pogostnost asimptomatskih motenj v delovanju srca je bila večja v skupini z dveletnim zdravljenjem (8,1 % proti 4,6 % v skupini z enoletnim zdravljenjem).
English: Studies indicate that breast cancer patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2.
Slovenian: Študije kažejo, da imajo bolniki z rakom dojk, katerih tumorji čezmerno izražajo HER2, krajše preživetje brez bolezni kot bolniki, katerih tumorji HER2 ne izražajo čezmerno.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Slovenian: Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na podlagi antraciklinov, so zdravili s paklitakselom samim (175 mg/m2, infundiranih v času 3 ur) ali skupaj s trastuzumabom.
English: There are no immunogenicity data available for trastuzumab in gastric cancer.
Slovenian: Za trastuzumab pri raku želodca ni na voljo podatkov o imunogenosti.
English: Trastuzumab plus docetaxel4 N=110
Slovenian: Trastuzumab in docetaksel4 N = 110
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in etiketi viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The median overall survival was extended by 4.6 months for patients in the combination arm.
Slovenian: Mediano celotno preživetje je bilo pri bolnicah, ki so jemale kombinacijo zdravil, daljše za 4,6 meseca.
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Slovenian: Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek (CL), volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.