natgillin/translations-raw huggingface dataset:
• Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious. 
• Včasih se lahko med zdravljenjem ali občasno tudi po končanem zdravljenju pojavijo težave s srcem, ki so lahko resne.
The loading dose should be administered as a 90-minute intravenous infusion. 
Polnitveni odmerek se daje kot 90-minutna intravenska infuzija.
For monotherapy, the rate was 6% - 9%. 
Za monoterapijo je bil odstotek 6 do 9.
HER2 testing must be performed in a specialised laboratory which can ensure adequate validation of the testing procedures (see section 5.1). 
Testiranje na HER2 mora biti opravljeno v specializiranem laboratoriju, ki lahko zagotavlja ustrezno validacijo postopka testiranja (glejte poglavje 5.1).
Approximately 17% of cardiac dysfunction related events occurred after completion of trastuzumab. 
Približno 17 % dogodkov, povezanih z motnjo delovanja srca, je nastopilo po zaključku zdravljenja s trastuzumabom.
The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples. 
Zunajcelična domena receptorja (ECD, p105) se lahko odcepi v krvni obtok in jo lahko določamo v serumskih vzorcih.
Accurate and validated assay methods should be used (see sections 4.4 and 5.1). 
Treba je uporabljati točne in validirane metode (glejte poglavji 4.4 in 5.1).
Fatalities have occurred within hours and up to one week following infusion. 
Do smrtnih primerov je prišlo v nekaj urah ali do enega tedna po infuziji.
Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2. 
Te metode morajo biti dovolj natančne in točne, da pokažejo čezmerno izražanje HER2 ter ločijo med srednjim (skladno z 2+) in močnim (skladno s 3+) čezmernim izražanjem HER2.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation. 
Rezultati učinkovitosti iz vmesne analize učinkovitosti so presegli s protokolom vnaprej določeno statistično mejo za primerjavo enoletnega zdravljenja s trastuzumabom z opazovanjem.
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. 
Vaš zdravnik bo med zdravljenjem in po njem redno nadzoroval vaše srce, če pa opazite katerega koli od zgoraj naštetih simptomov, nemudoma obvestite svojega zdravnika.
• you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer). 
• prejemate ali ste kadar koli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki se uporabljata za zdravljenje raka).
AUCss, 0-21days 
AUCss, 0-21. dan
If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear. 
Če se med zdravljenjem pojavijo simptomi, kot je mrzlica ali zvišana telesna temperatura, ne smete voziti ali upravljati strojev, dokler ti simptomi ne izginejo.
Do not use with glucose-containing solutions. 
Ne uporabljajte raztopin, ki vsebujejo glukozo.
For storage conditions of the reconstituted medicinal product, see section 6.3 and 6.6. 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavji 6.3 in 6.6.
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. 
Ti učinki se pojavijo predvsem med prvo intravensko infuzijo (»kapljanjem« zdravila v žilo) in prvih nekaj ur po pričetku infuzije.
• you have severe breathing problems at rest due to your cancer or if you need oxygen treatment. 
• imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s kisikom.
If you miss an appointment, ask your doctor when to schedule your next dose. 
Če izpustite odmerjanje zdravila, se posvetujte z zdravnikom, kdaj naj načrtujete naslednji odmerek.
Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients. 
Reverzibilnost blage simptomatske in asimptomatske disfunkcije levega prekata je bila dokazana pri 79,5 % bolnikov.
Greater than 70% of patients enrolled exhibited 3+ overexpression. 
Več kot 70 % vključenih bolnikov je izkazovalo čezmerno izražanje stopnje 3+.
What KANJINTI is and what it is used for 
Kaj je zdravilo KANJINTI in za kaj ga uporabljamo
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. 
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
The efficacy results from the BCIRG 006 are summarised in Tables 9 and 10. 
Rezultati učinkovitosti iz preskušanja BCIRG 006 so povzeti v preglednicah 9 in 10.
Slight foaming of the product upon reconstitution is not unusual. 
Rahlo penjenje zdravila po rekonstituciji ni nenavadno.
150 mg vial 
150 mg viala
FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio 
FP+H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a razmerje obetov
Women who become pregnant should be advised of the possibility of harm to the foetus. 
Ženske, ki zanosijo, je treba opozoriti na možnost poškodb ploda.
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached. 
TTP = čas do napredovanja bolezni; “no” - ni bilo mogoče oceniti ali pa še ni bilo doseženo; IZ = interval zaupanja.
Other side effects can occur at any time during treatment with trastuzumab, not just related to an infusion. 
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem s trastuzumabom in niso povezani le z infuzijo.
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”). 
Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje 2, »Opozorila in previdnostni ukrepi«).
The cells are only stained in part of their membrane. 
Celične membrane so le delno obarvane.
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 
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), 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), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
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 KANJINTI treatment. 
Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom KANJINTI.
Doses up to this level were well tolerated. 
Odmerke do te vrednosti so bolniki dobro prenašali.
Infusion solutions should be used immediately after dilution. 
Infuzijsko raztopino je treba uporabiti takoj po razredčitvi.
Each carton contains one vial. 
Ena škatla vsebuje eno vialo.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. 
• Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli to zdravilo.
(32-ne) 
(32-no)
Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of KANJINTI that can be withdrawn from the vial. 
Povzročitev pretiranega penjenja med rekonstitucijo ali tresenje že pripravljene raztopine lahko povzroči težave s količino zdravila KANJINTI, ki ga odvzamemo iz viale.
Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes. 
Pozorno je treba spremljati znake pnevmonitisa, še posebno pri bolnikih, ki se sočasno zdravijo s taksani.
What you need to know before you are given KANJINTI 
Kaj morate vedeti, preden boste prejeli zdravilo KANJINTI
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. 
Vendar velikost učinka teh sospremenljivk na izpostavljenost trastuzumabu nakazuje, da je malo verjetno, da bi te sospremenljivke klinično pomembno vplivale na koncentracijo trastuzumaba.
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. 
Hude anafilaktične reakcije, ki zahtevajo takojšnje dodatno posredovanje se lahko pojavijo, ponavadi med prvo ali drugo infuzijo trastuzumaba (glejte poglavje 4.4); povezane so lahko tudi s smrtnim izidom.
AUC0-21days 
AUC0-21.dan
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures. 
Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, ki lahko zagotavlja ustrezno validacijo postopka testiranja.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given trastuzumab. 
Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi trastuzumaba prišlo do smrtnih primerov;
Anaphylactoid reactions have been observed in isolated cases. 
Anafilaktoidne reakcije so opazili v posameznih primerih.
If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”). 
Če boste začetni odmerek dobro prenašali, boste nadaljnje odmerke prejeli v 30 minutah (glejte poglavje 2, »Opozorila in previdnostni ukrepi«).
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed. 
Poleg tega so izvedli primerjavo dvoletnega zdravljenja s trastuzumabom z enoletnim zdravljenjem s trastuzumabom.
See section 5.1 for chemotherapy combination dosing. 
Glejte poglavje 5.1 za odmerjanje v kombinaciji s kemoterapijo.
Chemo + trastuzumab (n = 115) 
Kemoterapija + trastuzumab (n = 115)
Therefore, these patients should not be treated with KANJINTI (see section 4.3). 
Zato takih bolnikov ne smemo zdraviti z zdravilom KANJINTI (glejte poglavje 4.3).
Infusion reactions, allergic-like reactions and hypersensitivity 
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost
Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development period was observed. 
Opazili so prehod trastuzumaba prek placente v zgodnjem obdobju (20. do 50. dan gestacije) in v poznem obdobju (120. do 150. dan gestacije) razvoja ploda.
For instructions on reconstitution of KANJINTI intravenous formulation before administration, see section 6.6. 
Za navodila glede rekonstitucije zdravila KANJINTI v intravenski obliki pred dajanjem glejte poglavje 6.6.
The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population in breast and gastric cancer (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s trastuzumabom za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Paediatric population There is no relevant use of trastuzumab in the paediatric population. 
Pediatrična populacija Uporaba trastuzumaba pri pediatrični populaciji ni smiselna.
Tell a doctor or nurse straight away, if you notice any of the following side effects: 
Zdravniku ali medicinski sestri morate takoj povedati, če opazite katerega od naslednjih neželenih učinkov:
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with KANJINTI. 
Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi zdravila KANJINTI;
Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). 
Trastuzumab je tudi močan mediator od protiteles odvisne celične citotoksičnosti (antibody-dependent cell-mediated cytotoxicity - ADCC).
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. 
Razlika ni bila statistično značilna, vendar pa je več kot polovica bolnikov iz skupine, ki je jemala le anastrozol po napredovanju bolezni, prešla na shemo, ki je vsebovala trastuzumab.
Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. 
Bolniki lahko nadaljujejo zdravljenje tudi med obdobji reverzibilne mielosupresije, ki je posledica kemoterapije, vendar pa jih je v tem času treba skrbno spremljati zaradi zapletov nevtropenije.
HER2 overexpression assessment 
Ocena čezmernega izražanja HER2
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D). 
Trastuzumab pa lahko zviša celokupno izpostavljenost enemu presnovku doksorubicina (7-deoksi-13-dihidro-doksorubicinonu, D7D).
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti.
• performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products. 
• Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse, zlasti glede aseptične priprave parenteralnih zdravil.
Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate. 
Bolnikom, pri katerih se pojavijo simptomi, povezani z infundiranjem (glejte poglavje 4.4), je treba svetovati, naj ne vozijo avtomobilov ali upravljajo strojev, dokler ti ne izzvenijo.
The presence of anti-trastuzumab antibodies had no impact on the 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. 
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 trastuzumaba v intravenski obliki.
• abnormally low oxygen levels in the blood 
• nenormalno malo kisika v krvi
KANJINTI intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins. 
Zdravilo KANJINTI v intravenski obliki se daje kot intravenska infuzija (»s kapljanjem«) neposredno v vaše žile.
(6.2-ne) 
(6,2-no)
All the terms included are based on the highest percentage seen in pivotal clinical trials. 
Pri vseh navedenih neželenih učinkih je upoštevan najvišji odstotek, opažen v ključnih kliničnih preskušanjih.
The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC. 
Volumen centralnega prostora je bil 2,62 l za bolnike z MBC in EBC ter 3,63 l za bolnike z AGC.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during KANJINTI therapy and for 7 months after the last dose. 
Ker se humani IgG1 izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem z zdravilom KANJINTI in še 7 mesecev po zadnjem odmerku.
In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome. 
V redkih primerih so imele te reakcije klinični potek, ki je privedel do smrtnega izida.
A study of trehalose, a major formulation excipient did not reveal any toxicities. 
Študija trehaloze, glavne pomožne snovi, ni pokazala nobene toksičnosti.
• blood infection 
• okužba krvi
The median duration of follow-up in the trastuzumab arm was 3.8 years. 
Mediana spremljanja v skupini, ki je prejemala trastuzumab, je bila 3,8 leta.
It is not known whether trastuzumab is secreted in human milk. 
Ni znano, ali se trastuzumab izloča v materino mleko pri ljudeh.
The dose of KANJINTI depends on your body weight. 
Odmerek zdravila KANJINTI je odvisen od vaše telesne mase.
Median follow-up 8 years** 
Mediani čas spremljanja 8 let**
Median follow-up 12 months* 
Mediani čas spremljanja 12 mesecev*
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C. 
Če se ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; običajno ne presegajo 24 ur pri temperaturi od 2 °C do 8 °C.
Total pathological complete response* (95% CI) 
Skupni popolni patološki odgovor* (95-% IZ)
• altered taste 
• sprememba okusa
The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16). 
Razpolovni čas se zmanjšuje z zmanjševanjem koncentracije v odmernem intervalu (glejte preglednico 16).
• you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine. 
• ste imeli srčno popuščanje, koronarno arterijsko bolezen, bolezen srčnih zaklopk (šum na srcu), visok krvni tlak, če jemljete ali ste jemali zdravila proti visokemu krvnemu tlaku;
+1Hypotension 
+1hipotenzija pogosto
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised KANJINTI, directing the stream into the lyophilised cake. 
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte primerno količino (kot navedeno zgoraj) sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo KANJINTI, usmerite curek na liofiliziran prašek.
Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8). 
Bolniki morajo biti pod nadzorom vsaj šest ur po začetku prve infuzije in dve uri po začetku nadaljnjih infuzij zaradi nevarnosti pojava simptomov, kot so zvišana telesna temperatura, mrzlica in drugi simptomi, povezani z infundiranjem (glejte poglavji 4.4 in 4.8).
The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%). 
Delež je bil najvišji pri bolnikih, ki so trastuzumab prejeli sočasno s taksanom (2,0 %).
The efficacy results from study MO16432 are summarised in Table 12. 
Rezultati učinkovitosti študije MO16432 so povzeti v preglednici 12.
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. 
V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC 3+ in/ali FISH-pozitivna.
These events may occur as part of an infusion-related reaction or with a delayed onset. 
Ti učinki se lahko pojavijo kot del infuzijske reakcije ali pa nastopijo kasneje.
It is important to check the product labels to ensure that the correct formulation is being given as prescribed. 
Pomembno je preveriti ovojnino zdravila in zagotoviti, da prejmete pravilno obliko, ki vam je bila predpisana.
• You have early breast cancer, with high levels of a protein called HER2. 
• imate zgodnjega raka dojk, pri katerem so izražene velike količine beljakovine, ki se imenuje HER2;
- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). 
- po operaciji, kemoterapiji (neoadjuvantni ali adjuvantni) in radioterapiji (če je primerno) (glejte poglavje 5.1);
Ask your doctor or pharmacist for advice before taking any medicine. 
Posvetujte se z zdravnikom ali farmacevtom, preden boste vzeli katero koli zdravilo.
A minority of patients was tested using fluorescence in-situ hybridisation (FISH). 
Manjši del bolnikov so testirali z metodo fluorescenčne hibridizacije in situ (FISH).
The powder is a white to pale yellow pellet. 
Prašek je bele do rahlo rumene barve.
In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file. 
Za izboljšanje sledljivosti tega zdravila morata zdravnik ali farmacevt v vašo zdravstveno kartoteko zabeležiti zaščiteno ime in številko serije zdravila, ki ste ga prejeli.
Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227). 
Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno vezane na dve študiji (MO16432 in BO22227).
Pre-medication may be used to reduce risk of occurrence of these events. 
Za zmanjšanje tveganja pojava teh neželenih učinkov lahko uporabimo premedikacijo.
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in table 6: 
Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6.
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. 
Pogostnost infuzijskih reakcij vseh stopenj je bila različna po študijah glede na indikacijo, metodologijo zbiranja podatkov in glede na to, ali so trastuzumab dajali sočasno s kemoterapijo ali v monoterapiji.
Study M77001: Full analysis set (intent-to-treat), 24 months results 
Študija M77001: celotna skupina bolnikov (bolniki, ki so jih nameravali zdraviti, intent-to-treat), rezultati po 24 mesecih.
Monitoring may help to identify patients who develop cardiac dysfunction. 
Spremljanje lahko olajša razpoznavo bolnikov, pri katerih se pojavijo motnje v delovanju srca.
Adjuvant treatment 
Adjuvantno zdravljenje
Patients were treated with trastuzumab until progression of disease. 
Bolniki so prejemali trastuzumab do napredovanja bolezni.