natgillin/translations-raw huggingface dataset:
Severe and prolonged (≥ 1 week) neutropenia can occur with this treatment which may increase the risk of patients developing serious infections.
Pri tem zdravljenju se lahko pojavi resna in podaljšana (≥ 1 teden) nevtropenija, ki lahko pri bolnikih poveča tveganje za razvoj resnih okužb.
If you have any questions on the use of this medicine, ask the doctor or nurse who is giving you the infusion.
Če imate kakršna koli vprašanja o uporabi tega zdravila, vprašajte zdravnika ali medicinsko sestro, ki vam daje infuzijo.
The efficacy results are shown in Table 7.
Rezultati učinkovitosti so prikazani v preglednici 7.
What Adcetris is and what it is used for
Kaj je zdravilo Adcetris in za kaj ga uporabljamo
Gastrointestinal complications
Gastrointestinalni zapleti
Testicular atrophy and degeneration were partially reversible following a 16-week treatment-free period.
Testikularna atrofija in degeneracija sta bili delno reverzibilni po 16-tedenskem obdobju brez zdravljenja.
If you develop infusion reactions (as stated previously), your doctor may stop giving this medicine and start support treatment.
Če se razvijejo infuzijske reakcije (kot so navedene zgoraj), lahko zdravnik preneha z dajanjem tega zdravila in uvede podporno zdravljenje.
Of the ITT population, 846 patients (64%) had Stage IV disease.
V populaciji ITT je imelo 846 bolnikov (64%) bolezen stadija IV.
After reconstitution/dilution, from a microbiological point of view, the product should be used immediately.
Po rekonstituciji/redčenju je treba zdravilo z mikrobiološkega vidika uporabiti takoj.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
For further efficacy results, see Table 12 and Figure 5.
Za nadaljnje rezultate učinkovitosti glejte preglednico 12 in sliko 5.
Your doctor or nurse will also monitor you during and after the infusion.
Zdravnik ali medicinska sestra vas bosta nadzirala med infundiranjem in po njem.
These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
Ti rezultati so skladni s farmakološkim učinkom MMAE na mitotski aparat (prekinitev mikrotubulnega omrežja) v celicah.
(95% CI [0.40, 0.81]) Stratified log-rank test p=0.001
(95% IZ [0,40, 0,81]) stratificirani test log-rank P = 0,001
The levels of MMAE metabolites have not been measured in human plasma.
Ravni presnovkov MMAE v človeški plazmi niso izmerili.
MMAE does not inhibit other isoforms.
MMAE ne zavira drugih izooblik.
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Median per IRF
Mediana po IRF
3.6 vials a.
3,6 viale a.
These infusion reactions can be serious or even fatal (known as an anaphylactic reaction).
Infuzijska reakcija je lahko huda ali celo smrtna (znana kot anafilaktična reakcija).
In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Pri ljudeh je bil povprečni volumen porazdelitve v stanju dinamičnega ravnovesja približno 6-10 l za ADC.
The median time from onset to resolution or improvement for all events ranged from 16 to 23.4 weeks.
Mediani čas od začetka do prenehanja ali izboljšanja vseh dogodkov je znašal od 16 do 23,4 tedna.
Other medicines and Adcetris
Druga zdravila in zdravilo Adcetris
The ADC is expected to be catabolised as a protein with component amino acids recycled or eliminated.
Pričakuje se, da se ADC katalizira kot beljakovina, pri čemer se sestavna aminokislina reciklira ali izloči.
The frequency of unique serious adverse drug reactions was ≤ 1%.
Pogostost edinstvenih resnih neželenih učinkov zdravila je znašala ≤ 1%.
Advanced age was a risk factor for febrile neutropenia in patients in both arms.
Višja starost je bila dejavnik tveganja za febrilno nevtropenijo pri bolnikih v obeh skupinah.
MMAE is a substrate of CYP3A4 and possibly CYP2D6.
MMAE je substrat encima CYP3A4 in morda tudi CYP2D6.
The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
Mediani čas od prvotne diagnoze sALCL do prvega odmerka zdravila ADCETRIS je bil 16,8 mesecev.
Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Pogostnost neželenih učinkov, navedenih v nadaljevanju in v preglednici 3, so določili na osnovi podatkov iz kliničnih študij.
HL at increased risk of relapse or progression
HL pri povečanem tveganju ponovitve ali napredovanja bolezni
The safety profile in elderly patients was consistent with that of adult patients.
Varnostni profil pri starejših bolnikih se je ujemal z varnostnim profilom pri odraslih bolnikih.
Treatment should be continued until disease progression or unacceptable toxicity(see section 4.4).
Zdravljenje je treba nadaljevati do napredovanja bolezni ali nesprejemljive toksičnosti (glejte poglavje 4.4).
What Adcetris is and what it is used for What you need to know before you are given Adcetris How Adcetris will be given Possible side effects
Kaj je zdravilo Adcetris in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Adcetris Kako se daje zdravilo Adcetris Možni neželeni učinki
Reconstituted/diluted solution: Use immediately or store in a refrigerator (2 C-8 °C) and use within 24 hours.
Rekonstituirana/razredčena raztopina: Uporabite takoj ali shranite v hladilniku (2 C-8 °C) ter porabite v 24 urah.
2.4 vials a.
2,4 viale a.
- are allergic to brentuximab vedotin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na brentuksimab vedotin ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, toda priporočil za odmerjanje ni mogoče podati.
Disease control rate (CR + PR + SD) Duration of response
Nadzorovana bolezen (CR + PR + SD) Trajanje odziva
There are no data from the use of ADCETRIS in pregnant women.
Podatkov o uporabi zdravila ADCETRIS pri nosečnicah ni.
A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba pretehtati potencialno tveganje dojenja za otroka in prednosti zdravljenja za mater.
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Velika Britanija
PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.
PML je redka demielinizacijska bolezen osrednjega živčnega sistema, ki je posledica reaktivacije latentnega JCV, in je pogosto smrtna.
Estimated 5-year OS Rate a.
Ocenjeno 5-letno celokupno preživetje a.
After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection.
Po prvem odmerku zdravila Adcetris v kombinaciji s kemoterapijo vam lahko zdravnik predpiše tudi zdravilo, ki pomaga preprečiti ali zmanjšati stopnjo resnosti nevtropenije (zmanjšanje števila belih krvnih celic), katera lahko poveča tveganje za okužbe.
40.5 months
40,5 meseca
CTCL is a cancer of a certain type of white blood cell called a ‘T-cell' that mainly affects the skin.
CTCL je rak določene vrste belih krvnih celic, imenovanih limfociti T, ki prizadene predvsem kožo.
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).
Zdravnik mora biti zlasti pozoren na simptome, ki nakazujejo na PML, in jih bolnik morda ne opazi (npr. kognitivni, nevrološki ali psihiatrični simptomi).
Response to treatment with ADCETRIS was assessed by Independent Review Facility (IRF) using the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007).
Odziv na zdravljenje z zdravilom ADCETRIS je ocenil neodvisen odbor za pregled (IRF) z uporabo revidiranih kriterijev odziva za maligni limfom (“Revised Response Criteria for Malignant Lymphoma”) (Cheson, 2007).
If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
Če je nosečnico treba zdraviti, jo je treba jasno opozoriti glede možnih tveganj za plod.
In the first cycle, higher MMAE exposure was associated with an absolute decrease in neutrophil count.
V prvem ciklusu je bila višja izpostavljenost MMAE povezana z absolutnim znižanjem števila nevtrofilcev.
Do NOT use Adcetris if you:
NE uporabljajte zdravila Adcetris:
The maximal recommended dose is 180 mg.
Največji priporočeni odmerek je 180 mg.
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Avstrija
Tell your doctor if you are taking any other medicines, if you have taken any recently, or if you start taking new ones.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Tega zdravila ne uporabljajte, če ste noseči, razen če zdravnik presodi, da so koristi za vas večje od možnega tveganja za nerojenega otroka.
Premedication may include paracetamol, an antihistamine and a corticosteroid.
Premedikacija lahko vključuje paracetamol, antihistaminik in kortikosteroid.
For intravenous use after reconstitution and dilution
za intravensko uporabo po rekonstituciji in razredčenju
Within each System Organ Class, adverse reactions are listed under frequency categories of: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Znotraj vsakega organskega sistema so neželeni učinki navedeni po kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The upper 90% confidence interval (CI) around the mean effect on QTc was < 10 msec at each of the Cycle 1 and Cycle 3 post-baseline time points.
Zgornji 90% interval zaupanja (IZ) okoli srednjega učinka na QTc je bil < 10 msek na vsaki časovni točki po izhodišču v 1. ciklu in 3. ciklu.
Partial Response
Delni odziv
Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Manj kot polovica bolnikov ključne populacije 2. faze z nevtropenijo 3. stopnje ali 4. stopnje je imela začasne povezane okužbe, pri čemer je bila večina začasnih povezanih okužb 1. ali 2. stopnje.
Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Podatki pri bolnikih s HL, ki niso kandidati za presaditev krvotvornih matičnih celic (PKMC)
Previously Untreated HL
Predhodno nezdravljeni HL
B symptoms
Simptomi B
More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
O resnejših neželenih dogodkih in spremembah odmerkov (vključno z odložitvami in zmanjšanjem odmerkov ter prekinitvami zdravljenja) so poročali pri starejših bolnih v primerjavi s celotno populacijo bolnikov, ki so sodelovali v študiji.
Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Devetinpetdeset odstotkov (59%) bolnikov je imelo ob ugotovitvi diagnoze bolezen v napredovalem stadiju (stadij III ali IV).
27.9 months
27,9 mesecev
Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Klasični Hodgkinov limfom izraža specifične beljakovine na površini celice, ki so drugačne od neklasičnega Hodgkinovega limfoma.
Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Zdravilo Adcetris se uporablja za zdravljenje CTCL v primerih, ko je na površini celic prisotna specifična vrsta proteina.
These patients should be monitored closely and managed according to best medical practice.
Te bolnike je treba skrbno nadzirati in zdraviti po najboljši medicinski praksi.
Proper aseptic technique throughout the handling of this medicinal product should be followed.
Ves čas ravnanja s tem zdravilom morate uporabljati ustrezne aseptične tehnike.
In vitro, MMAE was a substrate of P-gp and was not an inhibitor of P-gp at clinical concentrations.
In vitro je bil MMAE substrat P-gp in ne zaviralec P-gp v kliničnih koncentracijah.
Each vial contains approximately 13.2 mg of sodium.
Ena viala vsebuje približno 13,2 mg natrija.
Patients with known cerebral/meningeal disease, including history of PML were excluded from the study.
Bolniki z znano cerebralno/meningealno boleznijo, vključno z anamnezo PML, so bili izključeni iz študije.
This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 0,7% največjega priporočeneg dnevnega vnosa natrija s hrano za odrasle osebe.
The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Rekonstituirana raztopina v viali je bistra do rahlo opalescentna, brezbarvna raztopina s končno pH vrednostjo 6,6.
Exposures were approximately dose proportional with a trend observed for lower ADC exposures at lower ages/ body weights in the study population.
Izpostavljenosti so bile približno sorazmerne z odmerkom, s trendom z nižjo izpostavljenostjo ADC, ki je bil v študijski populaciji opažen pri nižjih starostih/telesnih masah.
Classical HL, sALCL and subtypes of CTCL (including MF and pcALCL) express CD30 as an antigen on the surface of their malignant cells.
Klasični HL, sALCL in podtipi CTCL (vključno z MF in pcALCL) izražajo CD30 kot antigen na površini svojih malignih celic.
Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
Bolniki, pri katerih se razvije limfopenija 3. stopnje ali 4. stopnje, lahko z zdravljenjem nadaljujejo brez prekinitve.
The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Delež najboljšega celokupnega odziva (ORR, “overall response rate”), po oceni odbora za neodvisni pregled (IRF, “independent review facility”), je bil v obeh študijskih fazah analiziran pri odmerku RP2D.
Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Na podlagi populacijske farmakokinetične ocene je bil običajen navidezen osrednji volumen porazdelitve za MMAE 35,5 l.
This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
To zdravilo vsebuje 13,2 mg natrija (glavne sestavine kuhinjske soli) na vialo.
Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Zagotavljanje rezultatov potekajoče neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet (PASS), ki se izvaja s populacijami bolnikov s HL in sALCL (študija MA25101).
Calculation to determine the total number of ADCETRIS vials needed:
Izračun za določitev skupnega števila potrebnih vial zdravila ADCETRIS:
This expression is independent of disease stage, line of therapy or transplant status.
To izražanje je neodvisno od stadija bolezni, vrste zdravljenja ali morebitne presaditve celic.
At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
V času analize je v obeh krakih mediani čas spremljanja modificiranega PFS znašal 24,6 mesecev Podatki iz vmesne analize OS
Best clinical response (n = 102 )
Najboljši klinični odziv (n = 102 )
ECOG status
Stanje zmogljivosti po ECOG
Relapsed or refractory sALCL
Ponovljen ali refraktarni sALCL
Best clinical response (n = 58 )
Najboljši klinični odziv (n = 58 )
Grade 3 (interfering with activities of daily living)
3. stopnja (motnje vsakodnevnih aktivnosti)
This medicine is given to you into a vein (intravenously) as an infusion.
To zdravilo se daje v veno (intravensko) v obliki infuzije.
The infusion may be restarted at a slower rate after symptom resolution.
Infundiranje se lahko ponovno začne z nižjo hitrostjo, ko simptomi izzvenijo.
In vitro studies using human liver microsomes indicate that MMAE inhibits only CYP3A4/5 at concentrations much higher than was achieved during clinical application.
Študije in vitro s človeškimi jetrnimi mikrosomi kažejo, da MMAE zavira samo CYP3A4/5 v koncentracijah, ki so veliko višje, kot so bile dosežene med klinično uporabo.
No patients required dose reduction or discontinued treatment for neutropenia.
Pri nobenem od bolnikov ni bilo potrebno zmanjšanje odmerka ali prekinitev zdravljenja zaradi nevtropenije.
Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Tega zdravila ne uporabljajte, če pred uporabo opazite kakršne koli trde delce ali obarvanost.
ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Periferna nevropatija, ki jo povzroči zdravilo ADCETRIS, je običajno učinek kumulativne izpostavljenosti temu zdravilu in je v večini primerov reverzibilna.
Patients who discontinued due to peripheral neuropathy received a median of 8 doses of ADCETRIS+AVD (A+AVD) before discontinuation of one or more agents.
Bolniki, pri katerih je bilo zdravljenje prekinjeno zaradi periferne nevropatije, so mediano prejeli 8 odmerkov zdravila ADCETRIS + AVD (A + AVD), preden so prenehali uporabljati eno ali več učinkovin.
Severity grade of neutropenia (signs and symptoms [abbreviated description of CTCAE a])
Stopnja resnosti nevtropenije (znaki in simptomi [okrajšan opis CTCAE a])
Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Oceno odziva so opravili v 2., 4., 7., 10., 13. in 16. ciklu in s slikanjem PET v 4. in 7. ciklu.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan 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.
Progressive multifocal leukoencephalopathy
Progresivna multifokalna levkoencefalopatija
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis)
4. stopnja (senzorična nevropatija, ki onemogoča vsakdanje dejavnosti ali motorična nevropatija, ki ogroža življenje ali vodi v paralizo)
Doxorubicin, vinblastine and dacarbazine (AVD)
Doksorubicin, vinblastin in dakarbazin (AVD)
Table 5 provides the efficacy results for modified PFS and overall survival (OS) in the ITT population and patients with Stage IV disease.
V preglednici 5 so navedeni rezultati učinkovitosti za modificirano PFS in celokupno preživetje (OS, “overall survival”) pri populaciji ITT in bolnikih z boleznijo stadija IV.
Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks
Zmanjšajte odmerek na 0,9 mg/kg do največ 90 mg vsaka 2 tedna.
No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Med obema skupinama zdravljenja niso zaznali pomembnih razlik glede kakovosti življenja (ki so jo ocenjevali z vprašalnikom EuroQol s petimi dimenzijami [EQ-5D] in splošnim vprašalnikom za funkcionalno oceno zdravljenja raka [FACT-G, “Functional Assessment of Cancer Therapy-General”]).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
V posamezni skupini glede na pogostnost so neželeni učinki navedeni po padajoči resnosti.
The analysis indicated that MMAE clearance was 2-fold lower in patients with low serum albumin concentrations <3.0 g/dl compared with patients with serum albumin concentrations within the normal range.
Analiza je pokazala, da je bil očistek MMAE 2-krat nižji pri bolnikih z nizkimi koncentracijami albumina v serumu < 3,0 g/dl v primerjavi z bolniki s koncentracijami albumina v serumu znotraj normalnega razpona.
No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Prednosti glede PFS ali OS pri bolnikih z enim dejavnikom tveganja ponovitve ali napredovanja bolezni niso bile opažene.
Excipient with known effect
Pomožne snovi z znanim učinkom
ADCETRIS dose (mg/kg) x patient's body weight (kg)
Odmerek zdravila ADCETRIS (mg/kg) x telesna masa bolnika (kg)
A monoclonal antibody is a protein which recognises certain cancer cells.
Monoklonsko protitelo je beljakovina, ki prepoznava nekatere rakave celice.
Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Od 329 bolnikov je bilo 165 bolnikov razporejenih v skupino z zdravilom ADCETRIS in 164 bolnikov v skupino s placebom.
Older patients who received G-CSF primary prophylaxis had lower incidence of neutropenia and febrile neutropenia than those who did not receive G-CSF primary prophylaxis.
Starejši bolniki, ki so prejeli primarno profilakso z G-CSF, so imeli manjšo incidenco nevtropenije in febrilne nevtropenije kot bolniki, ki niso prejeli primarne profilakse z G-CSF.
PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens.
O PML so poročali pri bolnikih, ki so prejeli zdravilo po predhodnem zdravljenju z več režimi kemoterapije.
Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse.
Analiza uporabe medicinskih virov (MRU, »medical resource utilization«) je pokazala, da je bilo hospitalizacij in ambulantnih obiskov, kot tudi delovnih dni/drugih dejavnosti, ki jih bolniki in skrbniki niso opravili, pri zdravljenju z zdravilom ADCETRIS manj v primerjavi z bolniki, ki so prejemali placebo, pri bolnikih s HL s povečanim tveganjem ponovitve bolezni.
You may experience the following side effects:
Pojavijo se lahko naslednji neželeni učinki:
The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Farmakokinetiko zdravila ADCETRIS v kombinaciji z AVD so ocenili v eni študiji 3. faze s podatki za 661 bolnikov.
Total volume per vial (10 mL/vial)
Skupni volumen na vialo (10 ml/vialo)