natgillin/translations-raw huggingface dataset:
• 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.
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.