natgillin/translations-raw huggingface dataset:
However, in most cases during Kadcyla treatment, liver enzyme levels are elevated mildly and temporarily, do not cause any symptoms, and do not affect liver function.
Toda v večini primerov so zvišanja jetrnih encimov med zdravljenjem z zdravilom Kadcyla blaga in prehodna, ne povzročajo simptomov in ne prizadenejo delovanja jeter.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C.
Kemična in fizikalna stabilnost pripravljene raztopine med uporabo sta dokazani za do 24 ur pri temperaturi od 2 do 8 °C.
In the event of a true hypersensitivity reaction (in which severity of reaction increases with subsequent infusions), trastuzumab emtansine treatment must be permanently discontinued.
Pri dejanski preobčutljivostni reakciji (pri kateri se njena izrazitost pri nadaljnjih infuzijah povečuje) je treba zdravljenje s trastuzumabom emtanzinom dokončno ukiniti.
Patients (n = 110) received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks until disease progression or unacceptable toxicity.
Bolniki (n = 110) so prejemali 3,6 mg/kg trastuzumaba emtanzina intravensko na 3 tedne do napredovanja bolezni ali nesprejemljivih neželenih učinkov.
Figure 3 Kaplan-meier curve of overall survival
Slika 3: Kaplan-Meierjeva krivulja celokupnega preživetja
Patients develop multiple nodules in the liver that can change how the liver functions.
Bolnikom se v jetrih pojavijo številni vozliči, ki lahko spremenijo delovanje jeter.
Administration of trastuzumab emtansine to pregnant women is not recommended and women should be informed of the possibility of harm to the foetus before they become pregnant.
Uporaba trastuzumaba emtanzina pri nosečnicah ni priporočljiva in ženske je treba seznaniti z možnostjo za okvaro ploda, preden zanosijo.
Patients were randomized (1:1) to receive trastuzumab or trastuzumab emtansine.
Bolnike so (v razmerju 1:1) randomizirali na prejemanje trastuzumaba ali trastuzumaba emtanzina.
DM1 did not inhibit major CYP450 enzymes in vitro.
DM1 in vitro ni zavrl pomembnih encimov CYP450.
ALT = alanine transaminase; AST = aspartate transaminase, CHF = congestive heart failure, LVEF = left ventricular ejection fraction, LVSD = left ventricular systolic dysfunction, TBILI = Total Bilirubin, ULN = upper limit of normal * Prior to starting trastuzumab emtansine treatment.
ALT = alanin-transaminaza, AST = aspartat-transaminaza, CHF = kongestivno srčno popuščanje (congestive heart failure), LVEF = iztisni delež levega prekata (left ventricular ejection fraction), LVSD = sistolična disfunkcija levega prekata (left ventricular systolic dysfunction), ZNM = zgornja meja normale * Pred začetkom zdravljenja s trastuzumabom emtanzinom.
Kadcyla (trastuzumab emtansine) and Herceptin (trastuzumab) are two very different products with different active substances never to be used interchangeably.
Zdravili Kadcyla (trastuzumab emtanzin) in Herceptin (trastuzumab) sta dve zelo različni zdravili z različnima učinkovinama, ki se nikoli ne smeta uporabljati izmenljivo.
Independent of race, the incidence of Grade 3 or 4 events (< 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Neodvisno od rase je bila incidenca dogodkov 3. ali 4. stopnje (< 50.000/mm3) pri bolnikih z MBC, zdravljenih s trastuzumabom emtanzinom, 8,7 % in 5,7 % pri bolnikih z EBC.
Patients with treated brain metastases were eligible for enrollment if they did not require therapy to control symptoms.
Bolniki z zasevki na možganih so bili primerni za vključitev, če za obvladovanje simptomov niso potrebovali zdravljenja.
If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying trastuzumab emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
Če je sočasna uporaba močnih zaviralcev CYP3A4 neizogibna, pride v poštev odložitev zdravljenja s trastuzumabom emtanzinom, dokler se močni zaviralec CYP3A4 ne odstrani iz obtoka (približno 3 eliminacijski razpolovni časi zaviralca), če je to mogoče.
In more severe cases, swelling of your face or tongue, trouble swallowing or difficulty breathing may occur.
V hujših primerih se lahko pojavijo oteklost obraza ali jezika, težave s požiranjem ali dihanjem.
The infusion may be continued after the symptoms improve.
Po izboljšanju simptomov se lahko infundiranje nadaljuje.
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Neželeni učinki so spodaj navedeni po organskem sistemu (razvrstitvi MedDRA) in kategoriji pogostnosti.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po pripravi in razredčenju glejte poglavje 6.3.
Patients should be clinically monitored on an ongoing basis for signs/symptoms of neurotoxicity.
Bolnike je treba stalno klinično kontrolirati zaradi možnih znakov ali simptomov nevrotoksičnosti.
If you are not sure, talk to your doctor or nurse before you are given Kadcyla.
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden boste dobili zdravilo Kadcyla.
· Heart problems: Kadcyla can weaken the heart muscle.
· Težave s srcem: Zdravilo Kadcyla lahko oslabi srčno mišico.
These reactions were usually mild or moderate and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site.
Te reakcije so bile po navadi blage ali zmerne in so obsegale eritem, občutljivost, draženje kože, bolečino ali oteklost na mestu infundiranja.
The co-primary efficacy endpoints of the study were progression-free survival (PFS) as assessed by an independent review committee (IRC) and overall survival (OS) (see Table 7 and Figures 2 to 3).
progression-free survival) po oceni neodvisnega odbora za pregled (IRC - independent review committee) in celokupno preživetje (OS - overall survival) (glejte preglednico 7 in sliki 2 in 3).
Kadcyla is used to treat breast cancer in adults when: · the cancer cells have many HER2 proteins on them - your doctor will test your cancer cells for this.
Zdravilo Kadcyla uporabljamo za zdravljenje raka dojk pri odraslih: · če imajo rakave celice na svoji površini veliko beljakovine HER2 - zdravnik bo zato opravil preiskavo rakavih celic,
There are insufficient data to establish the safety and efficacy in patients ≥ 75 years due to limited data in this subgroup.
Za ugotovitev varnosti in učinkovitosti pri bolnikih, starih ≥ 75 let, ni dovolj podatkov.
· When prepared as a solution for infusion Kadcyla is stable for up to 24 hours at 2°C to 8°C, and must be discarded thereafter.
· Če je zdravilo Kadcyla pripravljeno kot raztopina za infundiranje, je stabilno do 24 ur pri temperaturi od 2 do 8 °C, potem pa ga je treba zavreči.
The primary efficacy endpoint of the study was Invasive Disease-Free Survival (IDFS).
Primarni končni cilj učinkovitosti v študiji je bilo preživetje brez invazivne bolezni (IDFS - invasive disease-free survival).
If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Če se pri vas pojavi reakcija, bodo infundiranje upočasnili ali ustavili in vas zdravili, da bi nevtralizirali neželene učinke.
Patients with thrombocytopenia (≤ 100,000/mm3) and patients on anti-coagulant treatment (e.g. warfarin, heparin, low molecular weight heparins) should be monitored closely while on trastuzumab emtansine treatment.
Bolnike s trombocitopenijo (≤ 100.000/mm3) in bolnike, ki prejemajo antikoagulante (npr. varfarin, heparin, nizkomolekularne heparine), je treba med zdravljenjem s trastuzumabom emtanzinom natančno kontrolirati.
Some of these bleeding events resulted in fatal outcomes.
Nekateri primeri teh krvavitev so se končali s smrtjo.
Patients were treated with trastuzumab emtansine or trastuzumab for a total of 14 cycles unless there was recurrence of disease, withdrawal of consent, or unacceptable toxicity, whichever occurred first.
Bolnike so zdravili s trastuzumabom emtanzinom ali trastuzumabom skupno 14 ciklov, razen v primeru ponovitve bolezni, umika privolitve ali nesprejemljive toksičnosti, kar od tega se je zgodilo najprej.
How much you will be given · You will be given 3.6 mg of Kadcyla for every kilogram of your body weight.
Koliko zdravila Kadcyla boste dobili · Dobili boste 3,6 mg zdravila Kadcyla na kilogram telesne mase.
· Neurological problems: Kadcyla can damage nerves.
· Nevrološke težave: Zdravilo Kadcyla lahko okvari živce.
(ECD), as well as to Fcγ receptors and complement C1q.
(ECD - extracellular domain) HER2 ter na receptorje Fcγ in komplement C1q.
However, the magnitude of effect of these covariates on trastuzumab emtansine exposure suggests that these covariates are unlikely to have any clinically meaningful effect on trastuzumab emtansine exposure.
Vendar velikost njihovega učinka na izpostavljenost trastuzumabu emtanzinu kaže, da ni verjetno, da bi te sospremenljivke kakor koli klinično pomembno vplivale na izpostavljenost trastuzumabu emtanzinu.
No significant difference was observed in the PK of trastuzumab emtansine among patients < 65 years (n = 577), patients between 65-75 years (n = 78) and patients > 75 years (n = 16).
Farmakokinetika trastuzumaba emtanzina se ni bistveno razlikovala med bolniki, starimi < 65 let (n = 577), bolniki, starimi od 65 do 75 let (n = 78), in bolniki, starimi > 75 let (n = 16).
Patients should be observed during the infusion and for at least 30 minutes after infusion.
Bolnike je treba opazovati med infundiranjem in vsaj še 30 minut po njem.
Description of the key differences between trastuzumab emtansine and trastuzumab in relation to indication, dose, administration and packaging differences.
Opis glavnih razlik med trastuzumabom emtanzinom in trastuzumabom glede indikacij, odmerka, aplikacije in ovojnine.
If a prescription for Kadcyla (trastuzumab emtansine) is written electronically, it is important to ensure that the medicinal product prescribed is trastuzumab emtansine and not trastuzumab.
Če je recept za zdravilo Kadcyla (trastuzumab emtanzin) elektronski, je pomembno zagotoviti, da je predpisano zdravilo trastuzumab emtanzin in ne trastuzumab.
The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
Delež objektivnega odgovora je bil 32,7 % (95-% interval zaupanja: 24,1, 42,1), n = 36, tako po pregledu IRC kot po pregledu raziskovalca.
Kadcyla delayed patient-reported time to symptom progression for 7.1 months compared with 4.6 months for the control arm (Hazard Ratio 0.796 (0.667, 0.951); p-value 0.0121).
Zdravilo Kadcyla je zakasnilo čas do napredovanja simptomov, o katerem so poročali bolniki, za 7,1 meseca v primerjavi s 4,6 meseca v kontrolni skupini (razmerje ogroženosti 0,796 (0,667, 0,951); p-vrednost 0,0121).
Patients with baseline elevation of ALT (e.g. due to liver metastases) may be predisposed to liver injury with a higher risk of a Grade 3-5 hepatic event or liver function test increase.
Bolniki z izhodiščnim zvišanjem ALT (npr. zaradi jetrnih zasevkov) imajo lahko večje tveganje za poškodbo jeter z večjim tveganjem za jetrne neželene dogodke stopnje 3 do 5 ali zvišanje jetrnih testov.
You must not be given Kadcyla · if you are allergic to trastuzumab emtansine or any of the other ingredients of this medicine (listed in section 6).
· če ste alergični na trastuzumab emtanzin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In clinical studies, patients had a LVEF ³ 50% at baseline.
V kliničnih študijah so imeli bolniki izhodiščni LVEF ³ 50 %.
- Plasma concentrations of DM1 and DM1-containing catabolites (Lys-MCC-DM1 and MCC-DM1) were low and comparable between patients with and without hepatic impairment.
- Plazemske koncentracije DM1 in DM1 vsebujočih presnovkov (Lys-MCC-DM1 in MCC-DM1) so bile nizke in primerljive med bolniki z jetrno okvaro ali brez nje.
Patients should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
Bolniki naj prejmejo 14 ciklov zdravljenja v celoti, razen v primeru ponovitve bolezni ali neobvladljive toksičnosti.
The majority of the patients had Grade 1 or 2 events (≥ 50,000/mm3), with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥ 75,000/mm3) by the next scheduled dose.
Pri večini bolnikov je bil ta dogodek 1. ali 2. stopnje (≥ 50.000/mm3); najnižja vrednost je bila dosežena do 8. dne in se je na splošno izboljšala na stopnjo 0 ali 1. stopnjo (≥ 75.000/mm3) do naslednjega predvidenega odmerka.
Because most of the patients in trastuzumab emtansine clinical studies were females, the effect of gender on the PK of trastuzumab emtansine was not formally evaluated.
Ker je bila večina oseb v kliničnih študijah trastuzumaba emtanzina žensk, vpliva spola na farmakokinetiko trastuzumaba emtanzina niso formalno ocenili.
Trastuzumab emtansine has the mechanisms of action of both trastuzumab and DM1:
Trastuzumab emtanzin ima mehanizem delovanja obeh, trastuzumaba in DM1:
Patients treated with trastuzumab emtansine are at increased risk of developing left ventricular dysfunction.
Bolniki, zdravljeni s trastuzumabom emtanzinom, imajo večje tveganje za pojav disfunkcije levega prekata.
The liver is a primary organ for eliminating DM1 and DM1-containing catabolites.
Jetra so primarni organ za izločanje DM1 in DM1 vsebujočih presnovkov.
Patients with elevated transaminases improved to Grade 1 or normal within 30 days of the last dose of trastuzumab emtansine in the majority of the cases (see section 4.8).
Bolnikom z zvišanimi transaminazami se je stanje v večini primerov izboljšalo na 1. stopnjo ali se je normaliziralo v 30 dneh po zadnjem odmerku trastuzumaba emtanzina (glejte poglavje 4.8).
· Liver problems: Kadcyla can cause inflammation or damage to cells in the liver that can stop the liver from functioning normally.
· Težave z jetri: Zdravilo Kadcyla lahko povzroči vnetje ali okvaro jetrnih celic, ki lahko prepreči normalno delovanje jeter.
If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Če je razredčena v aseptičnih pogojih, je lahko shranjena do 24 ur pri temperaturi 2 do 8 °C.
· DM1, the cytotoxic component of trastuzumab emtansine, binds to tubulin.
● DM1, citotoksična komponenta trastuzumaba emtanzina, se veže na tubulin.
Increased transaminases were reported in 32.4% of patients with EBC.
O zvišanju transaminaz so poročali pri 32,4 % bolnikov z EBC.
Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine.
Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem s trastuzumabom emtanzinom in še 7 mesecev po zadnjem odmerku trastuzumaba emtanzina uporabljati učinkovito kontracepcijo.
Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Populacijska farmakokinetična analiza nakazuje, da starost nima klinično pomembnega vpliva na farmakokinetiko trastuzumaba emtanzina (glejte poglavji 5.1 in 5.2).
To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Uporabite pod nadzorom zdravnika, ki ima izkušnje z uporabo citotoksičnih zdravil.
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.
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.
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.
V študiji TDM4370g/BO21977 so ugotovili konsistentno dobrobit zdravljenja s trastuzumabom emtanzinom pri večini vnaprej opredeljenih ocenjenih podskupin; to potrjuje zanesljivost celotnega rezultata.
This abnormality causes the structure of the liver to change and can change how the liver functions.
Ta nepravilnost povzroči spreminjanje zgradbe jeter in lahko spremeni delovanje jeter.
In this patient population:
V tej populaciji so bili:
Do not administer trastuzumab emtansine at doses greater than 3.6 mg/kg once every 3 weeks 6.
Trastuzumaba emtanzina ne dajajte v odmerkih, večjih od 3,6 mg/kg vsake 3 tedne.
The infusion site should be closely monitored for possible subcutaneous infiltration during administration (see section 4.8).
Mesto infundiranja je treba skrbno kontrolirati zaradi možne subkutane infiltracije med dajanjem zdravila (glejte poglavje 4.8).
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.
Morebitne potrebe po prilagoditvi odmerka bolnikom s hudo ledvično okvaro ni mogoče ugotoviti, ker ni dovolj podatkov.
Some symptoms could be yellowing of your skin and whites of your eyes (jaundice).
Med simptomi je lahko porumenelost kože in očesnih beločnic (zlatenica).
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.
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.
· 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.
· 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.
Your doctor will check your blood regularly for decreased platelets.
Kri vam bo zdravnik redno pregledoval, da bi ugotovili, ali se je morda zmanjšalo število krvnih ploščic.
There are no data from the use of trastuzumab emtansine in pregnant women.
O uporabi trastuzumaba emtanzina pri nosečnicah ni podatkov.
· If you do become pregnant during treatment with Kadcyla, tell your doctor straight away.
· Če med zdravljenjem z zdravilom Kadcyla zanosite, morate to takoj povedati zdravniku.
Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Pri zdravljenju bolnikov z jetrno okvaro moramo biti previdni (glejte poglavji 4.2 in 5.2).
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.
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.
Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated.
Z infundiranjem povezane reakcije so minile v nekaj urah do enem dnevu po koncu infuzije.
In case of overdose, the patient should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Pri prevelikem odmerjanju je treba pri bolniku natančno kontrolirati znake in simptome neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
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.
Po uporabi je imelo 5,1 % (63/1243) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu na eni ali več časovnih točkah po odmerku.
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.
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.
There have been no studies performed with other routes of administration.
Študij o drugih načinih aplikacije niso izvedli.
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.
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.
Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Med znaki in simptomi so dispneja, kašelj, utrujenost in pljučni infiltrati.
Developmental toxicity of trastuzumab has been identified in the clinical setting although it was not predicted in the non-clinical program.
kliničnem okolju so ugotovili razvojno toksičnost trastuzumaba, čeprav je na podlagi predkliničnega programa ni bilo pričakovati.
In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
V študijah faze I in II je imelo 6,4 % (24/376) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu.
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.
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.
The median duration of response was not reached with trastuzumab emtansine vs. 9.5 months in the control arm.
Mediano trajanje odgovora na zdravljenje s trastuzumabom emtanzinom ni bilo doseženo, v kontrolni skupini pa je bilo 9,5 mesecev.
The reconstituted solution should be free of visible particulates, clear to slightly opalescent.
Pripravljena raztopina mora biti brez vidnih delcev in bistra do rahlo opalescenčna.
Observed cases may have been confounded by comorbidities and/or concomitant medicinal products with known hepatotoxic potential.
V zabeleženih primerih so na to morda vplivale sočasne bolezni in/ali sočasno uporabljena zdravila z možnimi hepatotoksičnimi učinki.
Grade 3 or 4 events were reported in 0.4% of patients with MBC.
Primere 3. ali 4. stopnje so zabeležili pri 0,4 % bolnikov z MBC.
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.
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.
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC14
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC14
DM1 was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
DM1 in vitro ni bil mutagen v bakterijskem preizkusu reverzne mutacije (Amesov test).
Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Druga redka nepravilnost, ki se lahko pojavi na jetrih, je stanje, imenovano nodularna regenerativna hiperplazija (NRH).
METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution
za intravensko uporabo po pripravi in redčenju
In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
V kliničnih študijah sta bili incidenca in izrazitost trombocitopenije večji pri azijskih bolnikih (glejte poglavje 4.8).