FrancophonIA/ELRC3.0 huggingface dataset:
English: Inflamed or injured liver cells may leak higher than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated liver enzymes in blood tests.
Slovenian: Vnete ali poškodovane jetrne celice lahko v kri sproščajo več določenih snovi (jetrnih encimov), kot je normalno, tako da je raven jetrnih encimov v krvi na preiskavah krvi zvišana.
English: In study TDM4370g/BO21977, consistent treatment benefit of trastuzumab emtansine was seen in the majority of pre-specified subgroups evaluated, supporting the robustness of the overall result.
Slovenian: V študiji TDM4370g/BO21977 so ugotovili konsistentno dobrobit zdravljenja s trastuzumabom emtanzinom pri večini vnaprej opredeljenih ocenjenih podskupin; to potrjuje zanesljivost celotnega rezultata.
English: This abnormality causes the structure of the liver to change and can change how the liver functions.
Slovenian: Ta nepravilnost povzroči spreminjanje zgradbe jeter in lahko spremeni delovanje jeter.
English: In this patient population:
Slovenian: V tej populaciji so bili:
English: Do not administer trastuzumab emtansine at doses greater than 3.6 mg/kg once every 3 weeks 6.
Slovenian: Trastuzumaba emtanzina ne dajajte v odmerkih, večjih od 3,6 mg/kg vsake 3 tedne.
English: The infusion site should be closely monitored for possible subcutaneous infiltration during administration (see section 4.8).
Slovenian: Mesto infundiranja je treba skrbno kontrolirati zaradi možne subkutane infiltracije med dajanjem zdravila (glejte poglavje 4.8).
English: The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data and therefore patients with severe renal impairment should be monitored carefully.
Slovenian: Morebitne potrebe po prilagoditvi odmerka bolnikom s hudo ledvično okvaro ni mogoče ugotoviti, ker ni dovolj podatkov.
English: Some symptoms could be yellowing of your skin and whites of your eyes (jaundice).
Slovenian: Med simptomi je lahko porumenelost kože in očesnih beločnic (zlatenica).
English: The median PFS was 9.2 months in the trastuzumab plus docetaxel arm and 14.2 months in the trastuzumab emtansine arm (hazard ratio, 0.59; p = 0.035), with a median follow-up of approximately 14 months in both arms.
Slovenian: Mediana PFS je bila 9,2 meseca v skupini s kombinacijo trastuzumaba in docetaksela ter 14,2 meseca v skupini s trastuzumabom emtanzinom (razmerje ogroženosti 0,59, p = 0,035); mediani čas spremljanja je bil v obeh skupinah približno 14 mesecev.
English: · Breathing problems: Kadcyla can cause serious breathing problems such as shortness of breath (either at rest or while performing any type of activity) and cough.
Slovenian: · Težave z dihanjem: Zdravilo Kadcyla lahko povzroči resne težave z dihanjem, na primer kratko sapo (lahko v mirovanju ali med izvajanjem kakršne koli dejavnosti) in kašelj.
English: Your doctor will check your blood regularly for decreased platelets.
Slovenian: Kri vam bo zdravnik redno pregledoval, da bi ugotovili, ali se je morda zmanjšalo število krvnih ploščic.
English: There are no data from the use of trastuzumab emtansine in pregnant women.
Slovenian: O uporabi trastuzumaba emtanzina pri nosečnicah ni podatkov.
English: · If you do become pregnant during treatment with Kadcyla, tell your doctor straight away.
Slovenian: · Če med zdravljenjem z zdravilom Kadcyla zanosite, morate to takoj povedati zdravniku.
English: Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Slovenian: Pri zdravljenju bolnikov z jetrno okvaro moramo biti previdni (glejte poglavji 4.2 in 5.2).
English: In the KATHERINE (BO27938) study, 3.7% (15/401) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 5 were also positive for neutralizing antibodies.
Slovenian: V študiji KATHERINE (BO27938) je imelo 3,7 % (15/401) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu, od katerih je jih je imelo 5 tudi nevtralizirajoča protitelesa.
English: Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated.
Slovenian: Z infundiranjem povezane reakcije so minile v nekaj urah do enem dnevu po koncu infuzije.
English: In case of overdose, the patient should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Slovenian: Pri prevelikem odmerjanju je treba pri bolniku natančno kontrolirati znake in simptome neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
English: Following trastuzumab emtansine dosing, 5.1% (63/1243) of patients tested positive for anti-trastuzumab emtansine antibodies at one or more post-dose time points.
Slovenian: Po uporabi je imelo 5,1 % (63/1243) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu na eni ali več časovnih točkah po odmerku.
English: If you experience flushing, shivering fits, fever, trouble breathing, low blood pressure or a rapid heartbeat (infusion-related reaction), blurred vision, tiredness, headache, or dizziness, do not drive, cycle, use tools or machines until these reactions stop.
Slovenian: Če se vam pojavijo rdečica, napadi mrazenja, zvišana telesna temperatura, težave z dihanjem, nizek krvni tlak ali hitro bitje srca (z infundiranjem povezana reakcija), zamegljen vid, utrujenost, glavobol ali omotica, ne upravljajte vozil, ne kolesarite in ne uporabljajte orodij ali strojev, dokler te reakcije ne minejo.
English: There have been no studies performed with other routes of administration.
Slovenian: Študij o drugih načinih aplikacije niso izvedli.
English: If you get any of the side effects after your treatment with Kadcyla has stopped, talk to your doctor or nurse and tell them that you have been treated with Kadcyla.
Slovenian: Če se vam kateri od neželenih učinkov pojavi po koncu zdravljenja z zdravilom Kadcyla, se morate posvetovati z zdravnikom ali medicinsko sestro in morate povedati, da ste dobivali zdravilo Kadcyla.
English: Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Slovenian: Med znaki in simptomi so dispneja, kašelj, utrujenost in pljučni infiltrati.
English: Developmental toxicity of trastuzumab has been identified in the clinical setting although it was not predicted in the non-clinical program.
Slovenian: kliničnem okolju so ugotovili razvojno toksičnost trastuzumaba, čeprav je na podlagi predkliničnega programa ni bilo pričakovati.
English: In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
Slovenian: V študijah faze I in II je imelo 6,4 % (24/376) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu.
English: Transaminase elevations were generally transient with peak elevation at day 8 after administration of therapy and subsequent recovery to Grade 1 or less prior to the next cycle.
Slovenian: Zvišanje transaminaz je bilo na splošno prehodno; vrh je doseglo 8. dan po uporabi zdravila in se je nato izboljšalo na 1. stopnjo ali manj pred naslednjim ciklom.
English: The median duration of response was not reached with trastuzumab emtansine vs. 9.5 months in the control arm.
Slovenian: Mediano trajanje odgovora na zdravljenje s trastuzumabom emtanzinom ni bilo doseženo, v kontrolni skupini pa je bilo 9,5 mesecev.
English: The reconstituted solution should be free of visible particulates, clear to slightly opalescent.
Slovenian: Pripravljena raztopina mora biti brez vidnih delcev in bistra do rahlo opalescenčna.
English: Observed cases may have been confounded by comorbidities and/or concomitant medicinal products with known hepatotoxic potential.
Slovenian: V zabeleženih primerih so na to morda vplivale sočasne bolezni in/ali sočasno uporabljena zdravila z možnimi hepatotoksičnimi učinki.
English: Grade 3 or 4 events were reported in 0.4% of patients with MBC.
Slovenian: Primere 3. ali 4. stopnje so zabeležili pri 0,4 % bolnikov z MBC.
English: Trastuzumab emtansine exposure (AUC) at Cycle 3 after repeated dosing in patients with mild or moderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Slovenian: Izpostavljenost trastuzumabu emtanzinu (AUC) v 3. ciklu po dajanju ponavljajočih se odmerkov bolnikom z blago ali zmerno okvarjenim delovanjem jeter je bila v območju, ki so ga opazili pri bolnikih z normalnim delovanjem jeter.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC14
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC14
English: DM1 was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Slovenian: DM1 in vitro ni bil mutagen v bakterijskem preizkusu reverzne mutacije (Amesov test).
English: Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Slovenian: Druga redka nepravilnost, ki se lahko pojavi na jetrih, je stanje, imenovano nodularna regenerativna hiperplazija (NRH).
English: METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution
Slovenian: za intravensko uporabo po pripravi in redčenju
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
Slovenian: V kliničnih študijah sta bili incidenca in izrazitost trombocitopenije večji pri azijskih bolnikih (glejte poglavje 4.8).
English: Discontinue treatment
Slovenian: Prenehanje zdravljenja
English: Figure 1 Kaplan-Meier Curve of Invasive Disease-Free Survival in KATHERINE
Slovenian: Slika 1: Kaplan-Meierjeva krivulja preživetja brez invazivne bolezni v študiji KATHERINE
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients.
Slovenian: V kliničnih študijah sta bili incidenca in izrazitost trombocitopenije večji pri azijskih bolnikih.
English: It must not be administered as an intravenous push or bolus.
Slovenian: Ne sme se ga dajati kot hiter intravenski odmerek ali bolus.
English: You should not breast-feed during treatment with Kadcyla.
Slovenian: Med zdravljenjem z zdravilom Kadcyla ne smete dojiti.
English: Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported.
Slovenian: O reakcijah, povezanih z infundiranjem, so poročali pri 1,6 % bolnikov z EBC; dogodkov 3. ali 4. stopnje ni bilo.
English: If you stop Kadcyla treatment Do not stop treatment with this medicine without talking to your doctor first.
Slovenian: Zdravljenja s tem zdravilom ne prenehajte, ne da bi se prej posvetovali z zdravnikom.
English: The objective response rate (ORR) was 58.0% with trastuzumab plus docetaxel and 64.2% with trastuzumab emtansine.
Slovenian: Delež objektivnega odgovora na zdravljenje je bil 58,0-% s kombinacijo trastuzumaba in docetaksela ter 64,2-% s trastuzumabom emtanzinom.
English: NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis.
Slovenian: Na nodularno regenerativno hiperplazijo jeter je treba pomisliti pri vseh bolnikih s kliničnimi simptomi portalne hipertenzije in/ali s cirozi podobno sliko na računalniški tomografiji (CT) jeter, a z normalnimi vrednostmi transaminaz in brez drugih znakov ciroze.
English: Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Slovenian: Pri zdravljenju bolnikov z jetrno okvaro moramo biti previdni zaradi znane hepatotoksičnosti, opažene pri uporabi trastuzumaba emtanzina (glejte poglavji 4.4 in 5.2).
English: The MAH shall agree the content and format of the Kadcyla (trastuzumab emtansine) educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla (trastuzumab emtansine) is launched in each Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora o vsebini in obliki izobraževalnega gradiva za zdravilo Kadcyla (trastuzumab emtanzin) dogovoriti s pristojnim nacionalnim organom v vsaki državi članici pred prihodom zdravila Kadcyla (trastuzumaba emtanzina) na trg.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično zdravilo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/885/001
English: · If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: · Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: It is recommended that platelet counts are monitored prior to each trastuzumab emtansine dose.
Slovenian: Število trombocitov je priporočljivo kontrolirati pred vsakim odmerkom trastuzumaba emtanzina.
English: Baseline patient and tumour characteristics were well balanced between treatment groups.
Slovenian: Izhodiščne značilnosti bolnikov in tumorjev so bile med terapevtskima skupinama dobro uravnotežene.
English: A cumulative effect of trastuzumab emtansine on transaminases has been observed, and generally recovered when treatment was discontinued.
Slovenian: Opažali so kumulativni učinek trastuzumaba emtanzina na transaminaze; na splošno so se vrednosti normalizirale po prenehanju zdravljenja.
English: Platelets help your blood to clot so you might get unexpected bruising or bleeding (such as nose bleeds, bleeding from gums).
Slovenian: Krvne ploščice sodelujejo pri strjevanju krvi, zato se lahko pojavijo nepričakovane modrice ali krvavitve (na primer iz nosu ali dlesni).
English: No dose relationship was observed in clinical studies.
Slovenian: niso bili vključeni v klinične študije.
English: A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
Slovenian: V sedmih kliničnih študijah so skupno 1243 bolnikom ob različnih časih testirali odziv protiteles proti zdravilu (ADA - anti-drug antibody) na trastuzumab emtanzin.
English: Patients with dyspnoea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary events.
Slovenian: Bolniki z dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni, sočasnih bolezni in sočasnega obsevanja pljuč imajo lahko večje tveganje za pljučne neželene dogodke.
English: · If the Kadcyla infusion solution leaks into the area around the infusion site you may develop tenderness or redness of your skin, or swelling at the infusion site.
Slovenian: · Če raztopina za infundiranje Kadcyla pronica v predel okrog mesta infundiranja, se lahko pojavi občutljivost ali pordelost kože ali oteklost na mestu infundiranja.
English: Hepatotoxicity, Hepatic failure, Nodular regenerative hyperplasia, Portal hypertension
Slovenian: odpoved jeter, nodularna regenerativna hiperplazija, portalna hipertenzija
English: Pulmonary Toxicity Interstitial lung disease (ILD) or pneumonitis
Slovenian: Intersticijska bolezen pljuč ali pnevmonitis
English: Pharmacokinetics of trastuzumab emtansine in patients with mild (creatinine clearance CLcr 60 to 89 mL/min, n = 254) or moderate (CLcr 30 to 59 mL/min, n = 53) renal impairment were similar to those in patients with normal renal function (CLcr ³ 90 mL/min, n = 361).
Slovenian: [CLcr] od 60 do 89 ml/min, n = 254) ali zmerno (CLcr od 30 do 59 ml/min, n = 53) ledvično okvaro podobna kot pri bolnikih z normalnim delovanjem ledvic (CLcr ³ 90 ml/min, n = 361).
English: Increased Transaminase (AST/ALT)
Slovenian: Zvišanje transaminaz (AST/ALT)
English: Hyperbilirubinemia Grade 2 (> 1.5 to ≤ 3´ the ULN)
Slovenian: Hiperbilirubinemija 2. stopnja (> 1,5 do ≤ 3´ ZNM)
English: In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of >10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors.
Slovenian: V opazovalni študiji (BO39807) se je pri približno 22 % (7 od 32) bolnikov z MBC, ki so imeli ob začetku zdravljenja s trastuzumabom emtanzinom izhodiščno vrednost LVEF 40-49%, pojavilo zmanjšanje LVEF za > 10 % od izhodišča in/ali kongestivno srčno popuščanje; večina teh bolnikov je imela druge srčno-žilne dejavnike tveganja.
English: By inhibiting tubulin polymerization, both DM1 and trastuzumab emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death.
Slovenian: Z zavrtjem polimerizacije tubulina DM1 in trastuzumab emtanzin ustavita celice v fazi celičnega cikla G2/M in navsezadnje povzročita apoptotično smrt celic.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/885/002
English: In patients with MBC, the overall incidence of peripheral neuropathy was 29.0% and 8.6% for Grade ≥ 2.
Slovenian: Pri bolnikih z MBC je bila skupna incidenca perifernih nevropatij 29,0 % in perifernih nevropatij ³ 2. stopnje 8,6 %.
English: You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
Slovenian: Zdravnik oziroma medicinska sestra vas bo opazovala med dajanjem zdravila in vsaj še 90 minut po prvem odmerku za primer, če bi se pojavil kateri koli neželeni učinek.
English: The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies.
Slovenian: Varnost trastuzumaba emtanzina so ocenili v kliničnih študijah pri 2611 bolnikih z rakom dojk.
English: You will be observed by a doctor or nurse while it is being given and for at least 30 minutes following the dose, in case you have any side effects.
Slovenian: Zdravnik oziroma medicinska sestra vas bo opazovala med dajanjem zdravila in vsaj še 30 minut po odmerku za primer, če bi se pojavil kateri koli neželeni učinek.
English: Increased Aspartate Transaminase (AST)
Slovenian: Zvišanje aspartattransaminaze (AST)
English: General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age (> 50 years), low baseline LVEF values (< 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI (> 25 kg/m2).
Slovenian: Med splošnimi dejavniki tveganja za srčni dogodek in tistimi, ki so jih ugotovili v študijah adjuvantnega zdravljenja raka dojk s trastuzumabom, so višja starost (> 50 let), nizek izhodiščni LVEF (< 55 %), nizek LVEF pred uporabo paklitaksela ali po njej med adjuvantnim zdravljenjem, predhodna ali sočasna uporaba antihipertenzivnih zdravil, predhodno zdravljenje z antraciklinom in visok ITM
English: - Systemic exposures (AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairment were approximately 38% and 67% lower than that of patients with normal hepatic function, respectively.
Slovenian: - Sistemska izpostavljenost trastuzumabu emtanzinu (AUC) v 1. ciklu je bila pri bolnikih z blago jetrno okvaro približno 38 %, pri bolnikih z zmerno jetrno okvaro pa 67 % nižja kot pri bolnikih z normalnim delovanjem jeter.
English: · Do not use this medicine after the expiry date which is stated on the outer carton and vial after EXP.
Slovenian: · Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do in na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Dedicated embryo-foetal development studies have not been conducted in animals with trastuzumab emtansine.
Slovenian: Namenskih študij embrio-fetalnega razvoja s trastuzumabom emtanzinom pri živalih niso izvedli.
English: · Bleeding problems: Kadcyla can lower the number of platelets in your blood.
Slovenian: · Težave s krvavitvami: Zaradi zdravila Kadcyla se vam lahko zmanjša število krvnih ploščic
English: Table 1 Dose reduction schedule
Slovenian: Preglednica 1: Shema zmanjševanja odmerka Shema zmanjševanja odmerka
English: Trastuzumab emtansine has not been studied in patients with serum transaminases > 2.5 ´ ULN or total bilirubin > 1.5 ´ ULN prior to initiation of treatment.
Slovenian: Trastuzumab emtanzin ni bil raziskan pri bolnikih, ki imajo pred uvedbo zdravljenja serumske transaminaze > 2,5´ ZNM ali celokupni bilirubin > 1,5´ ZNM.
English: · Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain
Slovenian: ● Tako kot trastuzumab se tudi trastuzumab emtanzin veže na domeno IV zunajcelične domene
English: Patients should be observed during the infusion and for at least 90 minutes following the initial infusion for fever, chills, or other infusion-related reactions.
Slovenian: Bolnike je treba med infundiranjem in vsaj še 90 minut po prvem odmerku opazovati zaradi možnosti zvišanja telesne temperature, pojava mrzlice in drugih z infundiranjem povezanih reakcij.
English: Based on population PK analysis, following intravenous administration, the central volume of distribution of trastuzumab emtansine was (3.13 L) and approximated that of plasma volume.
Slovenian: Na podlagi populacijske farmakokinetične analize je bil po intravenski uporabi centralni volumen porazdelitve trastuzumaba emtanzina 3,13 l in je bil približno tolikšen kot volumen plazme.
English: Patient demographics and baseline tumor characteristics were balanced between treatment arms.
Slovenian: Demografski podatki bolnikov in izhodiščne značilnosti tumorja so bili med terapevtskima skupinama dobro uravnoteženi.
English: No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Bolnikom z blago ali zmerno ledvično okvaro začetnega odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: · You should continue to take your contraception for at least 7 months after your last dose of
Slovenian: · Z uporabo kontracepcije nadaljujte vsaj še 7 mesecev po zadnjem odmerku zdravila Kadcyla.
English: Permanently discontinue trastuzumab emtansine in the absence of another likely cause for the elevation of liver enzymes and bilirubin, e.g. liver metastasis or concomitant medication
Slovenian: Dokončno prenehajte uporabljati trastuzumab emtanzin, če ni drugega verjetnega vzroka za zvišanje jetrnih encimov in bilirubina, npr. jetrnih zasevkov ali sočasnega zdravljenja.
English: The MAH shall ensure that in parallel to the launch of Kadcyla (trastuzumab emtansine), all health care professionals who may prescribe, dispense or administer Kadcyla (trastuzumab emtansine) and/or Herceptin (trastuzumab) are provided with a health care professional (HCP) educational pack.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila Kadcyla (trastuzumaba emtanzina) na trg, vsi zdravstveni delavci, ki lahko predpišejo, izdajo ali aplicirajo zdravilo Kadcyla (trastuzumab emtanzin) in/ali zdravilo Herceptin (trastuzumab) prejemejo paket izobraževalnih gradiv za zdravstvene delavce, ki ga sestavljajo:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Slovenian: Vsebnost natrija v pomožnih snoveh To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Use caution with these agents and consider additional monitoring when concomitant use is medically necessary.
Slovenian: Pri uporabi teh zdravil je potrebna previdnost in razmisliti je treba o dodatnem nadzoru,
English: Treat at the same dose level
Slovenian: Zdravljenje nadaljujte z enakim odmerkom.