natgillin/translations-raw huggingface dataset:
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions. 
Podrobnosti o ukrepih za zmanjšanje tveganj v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju ''Posebna opozorila in previdnostni ukrepi'' (poglavje 4.4).
Table 13 Efficacy Results from BO18225 Parameter 
Rezultati učinkovitosti preskušanja BO18225 Parameter
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Trazimera is given every 3 weeks. 
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Trazimera daje vsake 3 tedne.
For instructions on reconstitution of Trazimera intravenous formulation before administration, see section 6.6. 
Za navodila glede rekonstitucije zdravila Trazimera v intravenski obliki pred dajanjem glejte poglavje 6.6.
p-value versus AC→P 
p-vrednost v primerjavi z AC → P
If you receive Trazimera in combination with chemotherapy, some of them may also be due to the chemotherapy. 
Če zdravilo Trazimera prejemate v kombinaciji s kemoterapijo, so lahko nekateri neželeni učinki tudi posledica kemoterapije.
In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells. 
V splošnem velja, da je rezultat po metodi CISH pozitiven, če obstaja več kot 5 kopij gena HER2 na jedro v več kot 50 % tumorskih celic.
Do not stop using this medicine without talking to your doctor first. 
Če ste prenehali uporabljati zdravilo Trazimera Tega zdravila ne prenehajte uporabljati brez posvetovanja s svojim zdravnikom.
• You should use effective contraception during treatment with Trazimera and for at least 7 months after treatment has ended. 
• Med zdravljenjem z zdravilom Trazimera in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
Any remaining reconstituted solution should be discarded. 
Raztopino, ki ostane, je treba zavreči.
Monitoring may help to identify patients who develop cardiac dysfunction. 
Spremljanje lahko olajša razpoznavo bolnikov, pri katerih se pojavljajo motnje v delovanju srca.
DO NOT SHAKE! 
NE STRESAJTE!
• increased muscle tone or tension 
• astma povečan mišični tonus ali napetost
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Trazimera, or longer if a continuous decrease of LVEF is observed. 
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju zdravila Trazimera ali dlje, če se LVEF stalno zmanjšuje.
Trazimera may have a minor influence on the ability to drive or use machines (see section 4.8). 
Zdravilo Trazimera ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
Record the “discard by” date in the date field provided on the carton. 
Datum ''zavreči do'' zabeležite v podatkovno polje na škatlici.
This translates into an absolute benefit in terms of an 8 year disease free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment. 
To se izraža kot absolutna korist v smislu 8letnega preživetja brez ponovitve bolezni za 6,4 odstotne točke v prid 1-letnemu zdravljenju s trastuzumabom.
An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%). 
Absolutno korist 13 odstotnih točk v prid skupini, ki je prejemala trastuzumab, so ocenili v smislu 3letnega preživetja brez ponovitve bolezni (65 % v primerjavi z 52 %).
The efficacy results from Study MO16432 are summarized in Table 12. 
Rezultati učinkovitosti Študije MO16432 so povzeti v preglednici 12.
Therefore, these patients should not be treated with trastuzumab (see section 
Zato se takih bolnikov ne sme zdraviti s trastuzumabom (glejte poglavje
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 µg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. 
Vrednosti parametrov nelinearnega izločanja sta znašali 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
* (95% CI) 
* (95 % IZ)
These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine. 
Lahko se jih zdravi z analgetikom/antipiretikom, kot je meperidin ali paracetamol, ali antihistaminikom, kot je difenhidramin.
Ask your doctor or pharmacist for advice before taking any medicine. 
Posvetujte se z zdravnikom ali farmacevtom, preden boste vzeli katerokoli zdravilo.
If you experience any of the above symptoms when your treatment with Trazimera has finished, you should see your doctor and tell them that you have previously been treated with Trazimera. 
Če se vam katerikoli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Trazimera, obiščite svojega zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Trazimera.
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 popolnim patološkim odgovorom [pCR - pathological Complete Response] in preživetjem brez dogodka (Event Free Survival [EFS]) in varnost zdravila,
Trastuzumab 1 Year N=1693 
trastuzumab 1 leto n = 1.693
Trazimera is a biosimilar medicinal product. 
Zdravilo Trazimera je podobno biološko zdravilo.
(12.3-ne) 
(12,3 no)
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g., every 6 - 8 weeks). 
Za bolnike z asimptomatičnimi motnjami v delovanju srca je koristen pogostejši nadzor (npr. vsakih 6 do 8 tednov).
The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry. 
Glavna testna metoda, ki so jo uporabili za določanje pozitivnosti HER2 v ključnem preskušanju docetaksela skupaj s trastuzumabom ali brez njega, je bila imunohistokemija.
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. 
V zelo redkih primerih so se infuzijski in pljučni simptomi pojavili več kot 6 ur po začetku infundiranja trastuzumaba.
If you receive Trazimera 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. 
Če prejemate zdravilo Trazimera z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
(32-ne) 
(32,0-no)
Each carton contains one vial. 
Ena škatlica vsebuje eno vialo.
The median overall survival was extended by 4.6 months for patients in the combination arm. 
Mediana celokupnega preživetja je bila v skupini, ki je prejemala kombinacijo zdravil, daljša za 4,6 meseca.
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 foetus. 
Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se je potrebno uporabi trastuzumaba med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C. 
Po rekonstituciji s sterilno vodo za injekcije je pripravljena raztopina fizikalno in kemično stabilna 48 ur pri temperaturi 2 °C-8 °C.
Patients treated with Trazimera are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction. 
Pri bolnikih, ki so se zdravili z zdravilom Trazimera, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (NYHA - New York Heart Association, razred II-IV) ali asimptomatične motnje v delovanju srca.
Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC. 
Linearni očistek je bil 0,136 l/dan za bolnike z MBC, 0,112 l/dan za bolnike z EBC in 0,176 l/dan za bolnike z AGC.
Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). 
Trastuzumab je tudi močan mediator od protiteles odvisne celične citotoksičnosti (ADCC - Antibody-Dependent cell-mediated Cytotoxicity).
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa; ATC oznaka: L01XC03.
What Trazimera looks like and contents of the pack 
Izgled zdravila Trazimera in vsebina pakiranja
During a Trazimera infusion, chills, fever and other flu like symptoms may occur. 
Med infuzijo zdravila Trazimera se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
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. 
Previdnost je potrebna tudi pri zdravljenju bolnikov s povečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF < 55 %, in starejših bolnikih.
Trazimera is for single-use only, as the product contains no preservatives. 
Zdravilo Trazimera je samo za enkratno uporabo, saj ne vsebuje konzervansov.
• dry mouth and skin 
• krči v nogah suha usta in koža
5.2 Pharmacokineticproperties 
5.2 Farmakokinetične lastnosti
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. 
Ob pregledu varnosti zdravila po medianem spremljanju 3,5 do 3,8 leta je analiza preživetja brez ponovitve bolezni ponovno potrdila obseg koristi, ki jo je pokazala končna analiza preživetja brez ponovitve bolezni.
Like all medicines, Trazimera can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Trazimera neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Some of the side-effects you experience may be due to your underlying cancer. 
Vzrok nekaterim neželenim učinkom, ki jih opazite, je lahko vaša bolezen - rak.
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1). 
Pred začetkom zdravljenja je treba opraviti testiranje na HER2 (glejte poglavji 4.4 in 5.1).
From a microbiological point of view, the reconstituted solution and Trazimera infusion solution should be used immediately. 
Z mikrobiološkega stališča je treba pripravljeno raztopino zdravila Trazimera za infundiranje uporabiti takoj.
t1/2 range from Cmax,ss to Cmin,ss (day) 
Obseg t1/2od Cmax,ss do Cmin,ss (dan)
The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied. 
Varnosti nadaljevanja ali ponovnega zdravljenja s trastuzumabom pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
Denotes adverse reactions that are reported largely in association with Infusion-related reactions. 
Označuje neželene učinke, o katerih so večinoma poročali v zvezi z infuzijskimi reakcijami.
Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone. 
Trastuzumab so proučevali v randomiziranem, odprtem preskušanju 3. faze ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
• 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. 
• imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-fluorouracilom in cisplatinom.
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab. 
Če je mogoče, se po prekinitvi zdravljenja s trastuzumabom do 7 mesecev izogibamo zdravljenju z antraciklini.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied. 
Učinkovitosti trastuzumaba v kombinaciji s paklitakselom pri bolnikih, ki niso prejeli predhodne kemoterapije z antraciklinom, niso proučevali.
This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death. 
Tako stanje lahko škodi otroku v maternici in je povezano z nedozorelostjo pljuč ter lahko privede do smrti ploda.
Accurate and validated assay methods should be used (see sections 4.4 and 5.1). 
Treba je uporabljati točne in validirane testne metode (glejte poglavji 4.4 in
Danmark Pfizer ApS Tlf: +45 44 201 100 
Pfizer ApS Tlf: +45 44 201 100
Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions. 
Med najbolj resnimi in/ali pogostimi neželenimi učinki, o katerih so do zdaj poročali pri uporabi trastuzumaba (intravenske in subkutane oblike), so motnje v delovanju srca, infuzijske reakcije, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
Time to Disease Progression, Median months 
Čas do napredovanja bolezni, mediana (meseci)
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). 
Pri drugih parametrih so izboljšanje pri kombiniranem zdravljenju zabeležili pri celokupnem odgovoru (16,5 % v primerjavi s 6,7 %), deležu klinične koristi (42,7 % v primerjavi s 27,9 %) in času do napredovanja bolezni (4,8 meseca v primerjavi z 2,4 meseca).
- in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1). 
- v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom Trazimera,za lokalno napredovalo (tudi vnetno) bolezen ali tumorje s premerom > 2 cm (glejte poglavji 4.4 in 5.1).
If the patient has missed a dose of Trazimera by more than one week, a re-loading dose of Trazimera should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. 
Če je bolnik izpustil odmerek zdravila Trazimera za več kot 1 teden, mu je treba čim prej ponovno dati polnilni odmerek zdravila Trazimera v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
Cmin,ss = Cmin at steady state Cmax,ss = Cmax at steady state time to 90% of steady-state 
Cmin, ss = Cmin v stanju dinamičnega ravnovesja Cmax, ss = Cmax v stanju dinamičnega ravnovesja čas do 90 % stanja dinamičnega ravnovesja
Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly. 
Febrilna nevtropenija, levkopenija, anemija, trombocitopenija in nevtropenija so se pojavljale zelo pogosto.
Primary tumour type 
Vrsta primarnega tumorja
They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances. 
Vključujejo slabenje srčne mišice z možnostjo prehoda v srčno popuščanje, vnetje osrčnika in motnje srčnega ritma.
In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial. 
V preskušanju ToGA (BO18255) so bolnike, pri katerih so bili tumorji IHC3+ ali FISH pozitivni, definirali kot HER2-pozitivne in jih vključili v preskušanje.
If symptomatic cardiac failure develops during Trazimera therapy, it should be treated with standard medicinal products for CHF. 
Če se med zdravljenjem z zdravilom Trazimera razvije simptomatsko srčno popuščanje, ga je treba zdraviti s standardnimi zdravili za kongestivno srčno popuščanje.
As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. 
Posledično je trastuzumab tako v in vitro študijah kot tudi pri živalih zaviral proliferacijo človeških tumorskih celic, ki čezmerno izražajo HER2.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab. 
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m infundirano v 3 urah) samim ali skupaj s trastuzumabom.
12 weeks. 
70 mesecev.
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Trazimera (trastuzumab) and not trastuzumab emtansine. 
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Trazimera (trastuzumab) in ne trastuzumab emtanzin.
• (hypertonia) 
(hipertonija)
If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. 
Če odstotek LVEF pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, je treba zdravljenje prekiniti in v približno 3 tednih ponovno opraviti meritev LVEF.
Unopened vial can be stored up to 30ºC for a single period of up to 3 months. 
Neodprto vialo lahko shranite pri temperaturi do 30 °C za enkratno obdobje do 3 mesecev.
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. 
Analize za katerokoli drugo metodo, ki jo lahko uporabljamo za oceno izraženosti beljakovine ali gena HER2, lahko izvajajo le laboratoriji, ki uporabljajo ustrezne sodobne validirane metode.
In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e., did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4%). 
V treh ključnih kliničnih preskušanjih adjuvantnega zdravljenja s trastuzumabom v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (tj., ki niso prejeli trastuzumaba), in pri bolnikih, ki so prejeli trastuzumab zaporedno po taksanu (0,3 % do 0,4 %).
One vial contains 420 mg trastuzumab. 
Ena viala vsebuje 420 mg trastuzumaba.
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/m 
Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba, in visokim indeksom telesne mase (ITM) > 25 kg/m
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Trazimera, directing the stream into the lyophilised cake. 
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte ustrezen volumen (naveden zgoraj) sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Trazimera, in usmerite curek na liofiliziran prašek.
Median follow-up 12 months* Median follow-up 8 years** 
Mediani čas spremljanja 8 let**
Trastuzumab was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks. 
Trastuzumab so dajali tedensko s kemoterapijo, nato pa vsake 3 tedne, skupaj 52 tednov.
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator. 
Zdravilo shranjujte v dobro zaprti originalni ovojnini v hladilniku pri temperaturi 2 °C-8 °C.
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4). 
Kongestivno srčno popuščanje NYHA razreda II-IV, je pogost neželeni učinek, povezan z uporabo trastuzumaba; povezan je tudi s smrtnim izidom (glejte poglavje 4.4).
Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastrooesophageal junction not amenable to curative therapy. 
V preskušanje so vključili bolnike, ki se predhodno niso zdravili za HER2-pozitivni neoperabilni lokalno napredovali ali ponavljajoči se in/ali metastatski adenokarcinom želodca ali gastroezofagealnega prehoda ali niso bili primerni za zdravljenje.
Patients who receive anthracyclines after stopping trastuzumab may possibly be at increased risk of cardiac dysfunction. 
Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja s trastuzumabom, lahko obstaja večje tveganje za motnje v delovanju srca.
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. 
Študije kažejo, da imajo bolniki z rakom dojk, pri katerih tumorji čezmerno izražajo HER2, krajše preživetje brez ponovitve bolezni v primerjavi z bolniki, pri katerih tumorji ne izražajo HER2.
This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale. 
Preiskovalno metodo so zaradi kliničnega preskušanja izvajali v centralnem laboratoriju, kjer so za vrednotenje rezultatov uporabili lestvico od 0 do 3+.
What Trazimera contains - The active substance is trastuzumab. 
Kaj vsebuje zdravilo Trazimera - Učinkovina je trastuzumab.
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). 
Delež asimptomatskih motenj v delovanju srca je bil večji v skupini, ki se je zdravila 2 leti, (8,1 % v primerjavi s 4,6 % v skupini, ki se je zdravila 1 leto).