natgillin/translations-raw huggingface dataset:
Allow the vial to stand undisturbed for approximately 5 minutes. 
Pustite stati vialo pri miru približno 5 minut.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če zdravila ne uporabite takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
Not known: frequency cannot be estimated from the available data 
Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Children and adolescents Trazimera is not recommended for anyone under the age of 18 years. 
Otroci in mladostniki Zdravilo Trazimera ni priporočljivo za mlajše od 18 let.
88397 Biberach an der Riss Germany 
88397 Biberach an der Riss Nemčija
For intravenous/I.V. 
za intravensko/i.v.
One vial contains either: 
Ena viala vsebuje:
• Your doctor will advise you of the risks and benefits of taking Trazimera during pregnancy. 
• Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Trazimera v času nosečnosti.
Clinical experience is limited in patients above 65 years of age. 
Klinične izkušnje pri bolnikih, starejših od 65 let, so omejene.
This helps your medicine work as well as it can. 
To vašemu zdravilu omogoči, da deluje kar najbolj učinkovito.
This could be more serious if you are already breathless. 
Težave so lahko resnejše, če že težko dihate.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear. 
Biološka aktivnost D7D in klinični vpliv zaradi povišanja ravni tega presnovka nista bila jasna.
Your doctor will prescribe a dose and treatment regimen that is right for you. 
Vaš zdravnik vam bo predpisal odmerek in režim zdravljenja, ki bo primeren za vas.
In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors. 
V drugih primerih odločitev glede potrebe po dodatni citotoksični kemoterapiji temelji na dejavnikih posameznika.
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanja strojevi
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions. 
Zdravilo ni namenjeno shranjevanju po rekonstituciji in redčenju, razen če je to potekalo v kontroliranih in validiranih aseptičnih pogojih.
Total pathological complete response 
Skupni popolni patološki odgovor
All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule). 
Vse odmerke morate prejeti v ustreznem času vsak teden ali vsake 3 tedne (glede na vašo shemo odmerjanja).
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. 
Prisotnost trastuzumaba v serumu opičjih mladičev ni bila povezana z nobenimi neželenimi učinki na njihovo rast ali razvoj od rojstva do 1 meseca starosti.
Trazimera can cause breathing difficulties, especially when it is first given. 
Zdravilo Trazimera lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
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. 
Primarni opazovani dogodek v preskušanju je bilo celokupno preživetje, ki so ga definirali kot čas od dneva randomizacije do dneva smrti iz kateregakoli vzroka.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja)
For monotherapy, the rate was 6% - 9%. 
Za monoterapijo je bil ta odstotek 6-9 %.
Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur. 
Bolnike je treba opozoriti na možnost tako poznega pojava simptomov in jim svetovati, naj takoj obvestijo svojega zdravnika, če se ti simptomi pojavijo.
Your doctor will closely supervise your therapy. 
Vaš zdravnik bo pozorno spremljal vaše zdravljenje.
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). 
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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached. 
TTP = čas do napredovanja bolezni (time to progression); ''no'' = ni bilo mogoče oceniti ali pa še ni bilo doseženo; IZ = interval zaupanja
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, vendar kljub temu nemudoma obvestite svojega zdravnika, če opazite kateregakoli od zgoraj naštetih simptomov.
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever 
• majhno število rdečih in belih krvnih celic (ki pomagajo v boju proti okužbi), včasih s povišano telesno temperaturo
What you need to know before you are given Trazimera 
Kaj morate vedeti, preden boste prejeli zdravilo Trazimera
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. 
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika z infuzijo povezane reakcije.
Interruption or slowing the rate of the infusion may help control such symptoms. 
Prekinitev ali upočasnitev hitrosti infundiranja lahko pomaga pri nadzoru teh simptomov.
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 zmernim (skladno z 2+) in močnim (skladno s 3+) čezmernim izražanjem HER2.
Trazimera should only be given by a doctor or nurse. 
Zdravilo Trazimera lahko daje le zdravnik ali medicinska sestra.
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 je treba opraviti v specializiranem laboratoriju, ki lahko zagotovi ustrezno validacijo postopkov testiranja (glejte poglavje 5.1).
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 v prvih nekaj urah po pričetku infuzije.
The dose of Trazimera depends on your body weight. 
Odmerek zdravila Trazimera je odvisen od vaše telesne mase.
Slight foaming of the product upon reconstitution is not unusual. 
Rahlo penjenje zdravila po rekonstituciji ni neobičajno.
Serious reactions have been treated successfully with supportive therapy such as oxygen, beta- agonists, and corticosteroids. 
Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
Trazimera is for intravenous use. 
Zdravilo Trazimera je za intravensko uporabo.
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).
All the terms included are based on the highest percentage seen in pivotal clinical trials. 
Vsi navedeni neželeni učinki temeljijo na najvišjem odstotku, ki so ga opazili v ključnih kliničnih preskušanjih.
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 je treba testiranje opraviti v specializiranem laboratoriju, ki lahko zagotovi validacijo postopkov testiranja.
There is no relevant use of Trazimera in the paediatric population. 
Uporaba zdravila Trazimera pri pediatrični populaciji ni smiselna.
• you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer). 
• prejemate ali ste kadarkoli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki ju uporabljamo za zdravljenje raka).
FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin Odds ratio 
FP+H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin razmerje obetov
Once the infusion is prepared it should be administered immediately. 
Ko je infuzija pripravljena, jo je treba takoj infundirati.
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 Trazimera treatment. 
Če se bodo pri vas pojavili kakršnikoli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih 6 do 8 tednov); morda boste prejeli zdravila proti srčnemu popuščanju ali pa boste morali prekiniti zdravljenje z zdravilom Trazimera.
Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded. 
Bolnike z vrednostjo 2+ ali 3+ so vključili v preskušanje, tiste z 0 ali 1+ pa izključili.
For storage conditions of the reconstituted medicinal product, see sections 6.3 and 6.6. 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavji 6.3 in 6.6.
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, poročali so o smrtnih primerih (glejte poglavje 2, ''Opozorila in previdnostni ukrepi'').
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 jasno zabeležiti zaščiteno ime in številko serije uporabljenega zdravila.
These tissues were fixed in formalin or Bouin's fixative. 
Tkiva so fiksirali s formalinom ali v Bouinsovem fiksativu.
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake ''EXP''.
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D). 
Trastuzumab lahko poveča celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13- dihidro-doksorubicinonu, D7D).
Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported. 
Poročali so tudi o primerih začetnega izboljšanja, ki mu je sledilo klinično poslabšanje, in primerih zapoznelih reakcij s hitrim kliničnim poslabšanjem.
What Trazimera is and what it is used for 
Kaj je zdravilo Trazimera in za kaj ga uporabljamo
• 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 vzamete to zdravilo.
There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels. 
Obstajala je povezava med odcepljenim antigenom in vrednostmi SGOT/AST; del vpliva odcepljenega antigena na očistek bi bilo mogoče pojasniti z vrednostmi SGOT/AST.
The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10. 
Rezultati učinkovitosti iz preskušanja BCIRG 006 so povzeti v preglednicah 9 in 10.
In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials. 
Pri adjuvantnem zdravljenju so trastuzumab proučevali v 4 obsežnih, multicentričnih, randomiziranih preskušanjih:
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 pomembna, vendar pa je več kot polovica bolnic iz skupine, ki je prejemala le anastrozol, po napredovanju bolezni prešla na shemo, ki je vsebovala trastuzumab.
Doses up to this level were well tolerated. 
Odmerke do te velikosti so bolniki dobro prenašali.
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. 
Če se noseča ženska 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.
If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear. 
Če se vam med zdravljenjem pojavijo simptomi, kot je mrzlica ali zvišana telesna temperatura, ne smete voziti ali upravljati strojev, dokler ti simptomi ne izginejo.
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 katerokoli drugo zdravilo.
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Trazimera. 
Ta zdravila (ali katerikoli antraciklin) lahko poškodujejo srčno mišico in povečajo tveganje za nastanek težav s srcem pri uporabi zdravila Trazimera;
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'').
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 običajno lahko pojavijo med prvo ali drugo infuzijo trastuzumaba (glejte poglavje 4.4) in so lahko povezane tudi s smrtnim izidom.
• 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 potrebujete zdravljenje s kisikom.
The bag or bottle should be gently inverted to mix the solution in order to avoid foaming. 
Vrečko ali stekleničko je treba nežno obračati in zmešati raztopino tako, da se izognemo penjenju.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given Trazimera. 
Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi zdravila Trazimera prišlo do smrtnih primerov;
The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples. 
Zunajcelična domena receptorja (ECD - Extracellular Domain, p105) se lahko odcepi v krvni obtok in jo lahko določamo v serumskih vzorcih.
When Trazimera binds to HER2 it stops the growth of such cells and causes them to die. 
Ko se zdravilo Trazimera veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed. 
Poleg tega so izvedli tudi primerjavo 2-letnega zdravljenja s trastuzumabom z 1-letnim zdravljenjem s trastuzumabom.
If diluted aseptically, it may be stored for 24 hours (do not store above 30°C). 
Če je raztopljena v aseptičnih pogojih, jo lahko shranjujemo do 24 ur (shranjujte pri temperaturi do 30 °C).
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. 
Kljub temu velikost učinka teh sospremenljivk na izpostavljenost trastuzumabu kaže, da je malo verjetno, da bi te sospremenljivke klinično pomembno vplivale na koncentracijo trastuzumaba.
The loading dose should be administered as a 90-minute intravenous infusion. 
Polnilni odmerek se daje v obliki 90-minutne intravenske infuzije.
Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast. 
Zgodnji rak dojk je definiran kot nemetastatski, primarni, invazivni karcinom dojk.
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). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij trastuzumaba za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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 stopnje IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC 3+ in/ali FISH-pozitivna.
Concentration after reconstitution - 21 mg/mL 
koncentracija po rekonstituciji - 21 mg/ml
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 simptomi ne izzvenijo.
Some of these side effects may be serious and may lead to hospitalisation. 
Nekateri od teh neželenih učinkov so lahko resni in lahko zahtevajo zdravljenje v bolnišnici.
Therefore, these patients should not be treated with trastuzumab (see section 4.3). 
Zato se takih bolnikov ne sme zdraviti s trastuzumabom (glejte poglavje 4.3).
Other medicines and Trazimera 
Druga zdravila in zdravilo Trazimera
Overexpression of HER2 is observed in 20%-30% of primary breast cancers. 
Čezmerno izražanje HER2 so opazili pri 2030 % primarnega raka dojk.
Trastuzumab 1 Year N=1702*** 
trastuzumab 1 leto n = 1.702***
Chemo + Trastuzumab (n=115) 
Kemoterapija + trastuzumab (n = 115)
Treatment with Trazimera 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). 
Samostojno zdravljenje z zdravilom Trazimera ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
Observation N=1697*** 
opazovanje n = 1.697***
Other side effects can occur at any time during treatment with Trazimera, not just related to an infusion. 
Drugi neželeni učinki se lahko pojavijo kadarkoli med zdravljenjem z zdravilom Trazimera in niso povezani le z infuzijo.
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. 
V študiji za primerjavo metod (študija D008548) so ugotovili visoko stopnjo ujemanja (> 95 %) med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca.
Trazimera intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins. 
Zdravilo Trazimera v intravenski obliki se daje v obliki intravenske infuzije (''s kapljanjem'') neposredno v vaše žile.
The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+). 
Podatki kažejo, da so bili koristni učinki večji pri bolnikih z višjo stopnjo čezmernega izražanja HER2 (3+).
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 6 ur po začetku prve infuzije in 2 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).
It may take up to 7 months for Trazimera to be removed from your body. 
Lahko traja do 7 mesecev, da se zdravilo Trazimera popolnoma izloči iz vašega telesa.
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 prejemali sočasno s taksanom (2,0 %).
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 preskušanji (MO16432 in BO22227).
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30minute infusion. 
Če je bolnik začetni polnilni odmerek dobro prenašal, se lahko nadaljnje odmerke daje v obliki 30-minutne infuzije.
Women of childbearing potential should be advised to use effective contraception during treatment with Trazimera and for 7 months after treatment has concluded (see section 5.2). 
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Trazimera ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Trazimera therapy and for 7 months after the last dose. 
Ker se humani IgG izloča v materino mleko, potencialni škodljiv vpliv na otroka pa ni znan, ženske med zdravljenjem z zdravilom Trazimera in še 7 mesecev po zadnjem odmerku ne smejo dojiti.
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). 
Če se pojavi infuzijska reakcija, je treba infundiranje trastuzumaba prekiniti ali upočasniti njegovo hitrost in bolnika spremljati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
The powder is a white cake. 
Prašek je bela pogača.
Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. 
Predhodna kemoterapija mora vsebovati vsaj en antraciklinski in taksanski derivat, razen če bolniki niso bili primerni za takšno zdravljenje.