FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Slovenian: Primarni končni cilj preskušanja je bilo celotno preživetje, ki je bilo definirano kot čas od datuma randomizacije do datuma smrti ne glede na vzrok.
English: Ontruzant can cause breathing difficulties, especially when it is first given.
Slovenian: Zdravilo Ontruzant lahko povzroča težave z dihanjem, posebno takrat, ko vam ga dajo prvič.
English: Volume (mL) =
Slovenian: Volumen (ml) =
English: It is not known whether trastuzumab can affect reproductive capacity.
Slovenian: Ni znano, ali trastuzumab lahko škodljivo vpliva na sposobnost za razmnoževanje.
English: These tissues were fixed in formalin or Bouin's fixative.
Slovenian: Tkiva so bila fiksirana v formalinu ali Bouinovem fiksativu.
English: At the time of a safety update after a median of 3.5-3.8 years follow-up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Slovenian: Ob posodobitvi varnosti po medianem spremljanju 3,5-3,8 leta je analiza DFS spet potrdila velikost koristi, prikazane v končni analizi DFS.
English: AUC0-21days
Slovenian: AUC0-21 dni
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Slovenian: Vse odmerke morate prejeti pravočasno ali vsak teden ali vsake 3 tedne (odvisno od vaše sheme odmerjanja).
English: For time to response and duration of response no difference could be recorded between the arms.
Slovenian: Glede časa do odziva in trajanja odziva med skupinama ni bilo razlik v času.
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Slovenian: TTP = čas do napredovanja bolezni; “no” - ni bilo mogoče oceniti ali pa še ni bilo doseženo.
English: Other side effects that have been reported with Ontruzant use (frequency cannot be estimated from the available data):
Slovenian: Drugi neželeni učinki, o katerih so poročali pri uporabi zdravila Ontruzant (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: • you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
Slovenian: • ste kadar koli uporabljali ali trenutno uporabljate zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki se uporabljata za zdravljenje raka).
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Slovenian: Večina teh dogodkov nastopi znotraj 2,5 ure po začetku prve infuzije.
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Slovenian: Čezmerno izražanje HER2 opažamo pri 20 %-30 % primerov primarnega raka dojk.
English: Your doctor will closely supervise your therapy.
Slovenian: Vaš zdravnik bo natančno nadzoroval vaše zdravljenje.
English: Study MO16419
Slovenian: Študija MO16419.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Slovenian: Zdravnik vam bo predpisal odmerek in shemo zdravljenja, ki sta prava za vas.
English: Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Slovenian: Poročali so tudi o začetnem izboljšanju, ki mu sledi klinično poslabšanje in zapoznele reakcije s hitrim kliničnim poslabšanjem.
English: This could be more serious if you are already breathless.
Slovenian: Težave so lahko resnejše, če ste že zasopli.
English: Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Slovenian: Zdravnik bo med zdravljenjem in po njem redno nadzoroval vaše srce, vi pa morate zdravniku nemudoma povedati, če opazite katerega od zgoraj navedenih simptomov.
English: The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16).
Slovenian: t1/2 se zmanjšuje z zmanjševanjem koncentracij znotraj intervala odmerkov (glejte preglednico 16).
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Slovenian: Bolnike moramo posvariti pred možnostjo takega poznega nastopa in jim dati navodila, naj se obrnejo na svojega zdravnika, če se pojavijo ti simptomi.
English: Interruption or slowing the rate of the infusion may help control such symptoms.
Slovenian: Prekinitev ali upočasnitev hitrosti infuzije lahko pomaga pri nadzoru teh simptomov.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Slovenian: Več kot 70 % vključenih bolnikov je kazalo čezmerno izražanje 3+.
English: These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Slovenian: Ti učinki se pojavijo predvsem med prvo intravensko (“kapalno”) infuzijo v vašo veno in prvih nekaj ur po začetku infuzije.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Slovenian: Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje 2 pod “Opozorila in previdnostni ukrepi”).
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Slovenian: Bolnike, ki so jih razvrstili kot obarvanje 2+ ali 3+, so vključili, tiste, ki so se obarvali z 0 ali 1+, pa izključili.
English: • abnormally low oxygen levels in the blood
Slovenian: • nenormalno nizka raven kisika v krvi,
English: Therefore, no constant value for half-life of trastuzumab can be deduced.
Slovenian: Zato ni bilo mogoče določiti konstantne vrednosti za razpolovno dobo trastuzumaba.
English: Do not dilute with glucose solutions since these cause aggregation of the protein.
Slovenian: Ne redčite z raztopinami glukoze, ker povzročajo agregacijo beljakovin.
English: If you stop using Ontruzant
Slovenian: Če ste prenehali uporabljati zdravilo Ontruzant
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Slovenian: Vendar pa priporočajo tehnologijo SISH za vzporedno ocenjevanje histologije in morfologije tumorja.
English: The presence of trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 1 month of age.
Slovenian: Prisotnost trastuzumaba v serumu opičjih mladičev ni bila povezana z nobenimi neželenimi učinki na njihovo rast ali razvoj od kotitve do enega meseca starosti.
English: HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth.
Slovenian: HER2 najdemo v velikih količinah na površini nekaterih rakastih celic, kjer spodbuja njihovo rast.
English: A study of trehalose, a major formulation excipient, did not reveal any toxicities.
Slovenian: Študija trehaloze, glavne pomožne snovi zdravila, ni razkrila nikakršne toksičnosti.
English: In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Ontruzant should only be given by a doctor or nurse.
Slovenian: Zdravilo Ontruzant lahko daje samo zdravnik ali medicinska sestra.
English: Infusion solutions should be used immediately after dilution.
Slovenian: Infuzijske raztopine je treba porabiti takoj po razredčenju.
English: Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.
Slovenian: Pozorni moramo biti na pnevmonitis, posebno pri bolnikih, ki jih sočasno zdravimo s taksani.
English: • you suffer from breathlessness., especially if you are currently using a taxane.
Slovenian: • pri sebi opažate zasoplost, posebno še, če se trenutno zdravite s taksani.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 µg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Slovenian: Rezultati teh simulacij kažejo, da bo vsaj 95 % bolnikov po 7 mesecih doseglo koncentracije < 1 µg/ml (približno 3 % Cmin,ss, predvidene za populacijo, ali okrog 97-odstotno spiranje).
English: The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples.
Slovenian: Zunajcelična domena receptorja (ECD, p105) se lahko odcepi v krvni obtok in jo lahko merimo v vzorcih seruma.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Slovenian: To zdravilo vedno hranite v zaprtem originalnem pakiranju pri temperaturi 2 ºC - 8 ºC v hladilniku.
English: The median duration of follow-up in the trastuzumab arm was 3.8 years.
Slovenian: Mediano trajanje spremljanja v skupini s trastuzumabom je bilo 3,8 leta.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Slovenian: Reakcije na infuzijo, alergijskim podobne reakcije in preobčutljivost Ocenjujejo, da bo imelo približno 40 % bolnikov, zdravljenih s trastuzumabom, eno od oblik reakcije,
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Slovenian: Če je razredčena v aseptičnih razmerah, jo lahko hranite 24 ur (shranjujte pri temperaturi do 30 °C).
English: Ontruzant is for intravenous use.
Slovenian: Zdravilo Ontruzant je za intravensko uporabo.
English: t1/2 range from Cmax,ss to
Slovenian: Razpon t1/2 od Cmax,ss do
English: Due to non-linear elimination, total clearance increased with decreasing concentration.
Slovenian: Zaradi nelinearnega odstranjevanja je celotni očistek rastel ob padajoči koncentraciji.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ontruzant treatment.
Slovenian: Če se bodo pri vas razvili kakšni znaki popuščanja srca (znaki, da srce nezadostno črpa kri), vam bo zdravnik mogoče pregledoval delovanje srca pogosteje (vsakih šest do osem tednov), vam dal zdravila za popuščanje srca ali pa se boste mogoče morali prenehati zdraviti z zdravilom Ontruzant.
English: When Ontruzant binds to HER2 it stops the growth of such cells and causes them to die.
Slovenian: Ko se zdravilo Ontruzant veže na HER2, zaustavi rast takih celic in povzroči njihovo smrt.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Slovenian: Resne reakcije so uspešno zdravili s podpornim zdravljenjem, na primer kisikom, agonisti beta in kortikosteroidi.
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Slovenian: Rezultati učinkovitosti iz študije BCIRG 006 so povzeti v preglednicah 9 in 10.
English: To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Slovenian: Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, ki lahko zagotavlja validacijo postopkov testiranja.
English: What you need to know before you are given Ontruzant Do not use Ontruzant if:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ontruzant Ne uporabljajte zdravila Ontruzant, če:
English: If you receive Ontruzant in combination with chemotherapy, some of them may also be due to the chemotherapy.
Slovenian: Če prejemate zdravilo Ontruzant skupaj s kemoterapijo, lahko nekateri od njih nastanejo tudi zaradi kemoterapije.
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Slovenian: Pri adjuvantnem zdravljenju so trastuzumab proučevali v 4 velikih multicentričnih randomiziranih preskušanjih.
English: (week)
Slovenian: (tedni)
English: If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Slovenian: Če se nosečnica zdravi s trastuzumabom ali če bolnica zanosi med zdravljenjem s trastuzumabom ali v obdobju 7 mesecev po prejemu zadnjega odmerka trastuzumaba, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
English: 2616 LR Delft The Netherlands
Slovenian: 2616 LR Delft Nizozemska
English: Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Slovenian: Klinično pomembnega medsebojnega delovanja med trastuzumabom in sočasno uporabljenimi zdravili v kliničnih preskušanjih, niso opazili.
English: From a microbiological point of view, the reconstituted solution and Ontruzant infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba rekonstituirano raztopino in raztopino zdravila Ontruzant za infundiranje uporabiti takoj.
English: • You have early breast cancer, with high levels of a protein called HER2.
Slovenian: • imate zgodnjega raka dojk z visoko ravnijo beljakovine, ki se imenuje HER2;
English: 12.2 (6.2-ne)
Slovenian: 12,2 (6,2-no)
English: • dry mouth and skin
Slovenian: • suha usta in koža,
English: Fatalities have occurred within hours and up to one week following infusion.
Slovenian: Smrt je nastopila v nekaj urah do en teden po infuziji.
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Slovenian: Poleg tega so opravili primerjavo dveletnega zdravljenja s trastuzumabom z enoletnim zdravljenjem s trastuzumabom.
English: The dose of Ontruzant depends on your body weight.
Slovenian: Odmerek zdravila Ontruzant je odvisen od vaše telesne mase.
English: • low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
Slovenian: • zmanjšano število rdečih in belih krvničk (ki pomagajo pri borbi proti okužbi), včasih z zvišano telesno temperaturo,
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s trastuzumabom za vse podskupine pediatrične populacije za raka dojk in želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Slovenian: Dolgoročnih študij na živalih za ugotavljanje kancerogenega potenciala trastuzumaba ali za ugotavljanje njegovih učinkov na plodnost moških niso opravili.
English: Slight foaming of the product upon reconstitution is not unusual.
Slovenian: Lahno penjenje zdravila ob rekonstituciji ni nenavadno.
English: FP + H: fluoropyrimidine/cisplatin + trastuzumab FP: fluoropyrimidine/cisplatin a Odds ratio
Slovenian: FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a kvocient verjetnosti
English: However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates are unlikely to have a clinically meaningful effect on trastuzumab concentrations.
Slovenian: Vendar velikost učinka teh sospremenljivk na izpostavljenost trastuzumabu kaže, da je malo verjetno, da bi te sospremenljivke klinično pomembno vplivale na koncentracije trastuzumaba.
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal development period was observed.
Slovenian: Opazili so prehod trastuzumaba skozi posteljico v zgodnjem obdobju (20.-50. dan gestacije) in v poznem obdobju (120.-150. dan gestacije) razvoja ploda.
English: • swelling or bleeding at the back of the eyes
Slovenian: • otekanje ali krvavitev v očesnem ozadju,
English: Chemotherapy was administered as follows:
Slovenian: Kemoterapijo so dajali takole:
English: If the first dose is well tolerated the next doses may be given over 30 minutes.
Slovenian: Če boste dobro prenesli prvi odmerek, vam bodo naslednje odmerke dajali po 30 minut.
English: The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Slovenian: Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS]) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo intravenskega trastuzumaba.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Slovenian: Polnilni odmerek zdravila Ontruzant se daje kot 90-minutna intravenska infuzija.
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Slovenian: Ti dogodki se lahko pojavijo kot del reakcije na infuzijo ali pa nastopijo pozneje.
English: Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Slovenian: Zato teh bolnikov ne smemo zdraviti s trastuzumabom (glejte poglavje 4.3).
English: Total pathological complete response* (95% CI)
Slovenian: Popoln patološki celoten odziv* (95 % IZ)
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Slovenian: Hude anafilaktične reakcije, pri katerih je potrebno takojšnje dodatno posredovanje, se lahko navadno pojavijo bodisi med prvo bodisi med drugo infuzijo trastuzumaba (glejte poglavje 4.4) in so bile povezane s smrtnim izidom.
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Slovenian: V tem preskušanju je imelo 87 % vključenih bolnikov bolezen, ki je bila IHC3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC3+ in/ali FISH-pozitivna.
English: Other medicines and Ontruzant
Slovenian: Druga zdravila in zdravilo Ontruzant
English: Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Slovenian: Če se pojavi reakcija na infuzijo, je treba infundiranje trastuzumaba prekiniti ali upočasniti hitrost infundiranja, bolnika pa je treba spremljati, dokler vsi opaženi simptomi ne izzvenijo (glejte poglavje 4.2).
English: Patients were treated with trastuzumab until progression of disease.
Slovenian: Bolnike so zdravili s trastuzumabom do napredovanja bolezni.
English: Your doctor may prescribe Ontruzant for the treatment of breast and gastric cancer when:
Slovenian: Zdravnik vam lahko predpiše zdravilo Ontruzant za zdravljenje raka dojk in raka želodca, kadar:
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Slovenian: Razlika ni bila statistično značilna, vendar pa je več kot polovica bolnic iz skupine, ki je jemala le anastrozol po napredovanju bolezni, prešla na shemo, ki je vsebovala trastuzumab.
English: For instructions on reconstitution of Ontruzant intravenous formulation before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila Ontruzant v intravenski obliki pred dajanjem glejte poglavje 6.6.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ontruzant.
Slovenian: Zelo redko je pri bolnikih, ki so imeli pred zdravljenjem hude težave z dihanjem, prišlo do smrtnih primerov ob prejemu zdravila Ontruzant;
English: This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Slovenian: Pri tej raziskovalni metodi v kliničnem preskušanju, ki so jo opravljali v centralnem laboratoriju, so uporabljali lestvico od 0 do 3+.
English: Occasionally, symptoms start later than six hours after the infusion begins.
Slovenian: Včasih se simptomi pojavijo več kot šest ur po začetku infuzije.
English: Once the infusion is prepared it should be administered immediately.
Slovenian: Ko je infuzija pripravljena, jo uporabite takoj.
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to the trial MO16432.
Slovenian: Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno omejene na preskušanje MO16432.
English: Trastuzumab 1 Year N=1702***
Slovenian: Trastuzumab 1 leto N = 1702***
English: The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Slovenian: Volumen centralnega prostora je bil 2,62 l pri bolnikih z MBC in EBC in 3,63 l pri bolnikih z AGC.
English: In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Slovenian: V študiji primerjave metod (študija D008548) so ugotovili visoko stopnjo skladnosti (> 95 %) za tehniki SISH in FISH za odkrivanje genske amplifikacije HER2 pri bolnikih z rakom želodca.
English: Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Slovenian: Ženske v rodni dobi Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s trastuzumabom in še 7 mesecev po koncu zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
English: • hypertonia
Slovenian: • hipertonija
English: It may take up to 7 months for Ontruzant to be removed from the body.
Slovenian: Lahko traja do 7 mesecev, da se zdravilo Ontruzant odstrani iz telesa.
English: Observation N=1697***
Slovenian: Opazovanje N = 1697***
English: After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Slovenian: Po rekonstituciji s sterilno vodo za injekcije je rekonstituirana raztopina fizikalno in kemijsko stabilna 48 ur pri 2 °C-8 °C.
English: Treatment with Ontruzant (alone or with a taxane) may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Slovenian: Samostojno zdravljenje z zdravilom Ontruzant ali v kombinaciji s taksanom lahko vpliva na srce, posebno še, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with intravenous trastuzumab developed antibodies against trastuzumab.
Slovenian: V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko trastuzumabom, razvila protitelesa proti trastuzumabu.