natgillin/translations-raw huggingface dataset:
• Distribution of the product
• distribucije zdravila
After oral administration of a radiolabelled dose, vismodegib is absorbed and slowly eliminated by a combination of metabolism and excretion of parent drug substance, the majority of which is recovered in the faeces (82 % of the administered dose), with 4.4 % of the administered dose recovered in urine.
Po peroralni uporabi radioaktivno označenega odmerka se vismodegib absorbira in počasi odstrani s kombinacijo presnove in izločanja izvorne učinkovine, od katerega se večina (82 % uporabljenega odmerka) pojavi v blatu, 4,4 % uporabljenega odmerka pa v urinu.
**Includes preferred terms: liver function test abnormal, blood bilirubin increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, liver hepatic enzyme increased.
**Vključuje termine: nenormalne vrednosti jetrnih testov, zvišan bilirubin v krvi, zvišana gama glutamiltransferaza, zvišana aspartat aminotransferaza, zvišana alkalna fosfataza, zvišani jetrni encimi.
Erivedge is indicated for the treatment of adult patients with:
4.1 Terapevtske indikacije Zdravilo Erivedge je indicirano za zdravljenje odraslih bolnikov:
Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Erivedge neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Results from a clinical study demonstrated a 57% increase in vismodegib unbound drug concentrations on day 7 after co-treatment with 400 mg fluconazole (a moderate CYP2C9 inhibitor) daily, but this interaction is not expected to be clinically significant.
Izsledki klinične študije so pokazali 57-% zvečanje koncentracij nevezanega vismodegiba 7. dan po sočasnem zdravljenju s 400 mg flukonazola (zmernega zaviralca CYP2C9) na dan, a ni pričakovati, da bi bila ta interakcija klinično pomembna.
• Liver injury Serious skin reactions:
• resne kožne reakcije:
Do not take Erivedge if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Ne jemljite zdravila Erivedge, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev med zdravljenjem ali v 24 mesecih po zadnjem odmerku tega zdravila.
***** Cases of drug induced liver injury have been reported in patients during post-marketing use.
*****O primerih okvare jeter zaradi zdravil so pri bolnikih poročali po prihodu zdravila na trg.
Excipients Erivedge capsules contain lactose monohydrate.
Kapsule zdravila Erivedge vsebujejo laktozo monohidrat.
You must not become pregnant while taking this medicine.
Med jemanjem tega zdravila ne smete zanositi.
Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Zdravilo Erivedge sme predpisati le zdravnik specialist, ki ima izkušnje z vodenjem zdravljenja pri odobreni indikaciji, oziroma se ga sme predpisati le pod nadzorstvom takšnega zdravnika.
If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.
Bolnikom je treba naročiti, naj v primeru, da pozabijo vzeti odmerek zdravila, pozabljenega odmerka ne vzamejo, temveč naj jemanje nadaljujejo z naslednjim odmerkom po urniku.
What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Erivedge je zdravilo za zdravljenje raka in vsebuje učinkovino vismodegib.
The majority of patients were male (57%); 8% had mBCC whereas 92% had laBCC.
Večina bolnikov je bila moških (57 %): 8 % jih je imelo metastatski bazalnocelični karcinom, medtem ko jih je 92 % imelo lokalno napredovali bazalnocelični karcinom.
• if you are also taking St John's wort (Hypericum perforatum) - a herbal medicine used for depression (see “Other medicines and Erivedge”).
• jemljete tudi šentjanževko (Hypericum perforatum) - zeliščno zdravilo, ki se uporablja za zdravljenje depresije (glejte Druga zdravila in zdravilo Erivedge).
No dose adjustment is required in patients ≥ 65years of age (see section 5.2).
Bolnikom, starim 65 let ali več, odmerka ni treba prilagoditi (glejte poglavje 5.2).
• Brief background on Erivedge, its licensed indication and posology
• kratko ozadje o zdravilu Erivedge, njegovo indikacijo in odmerjanje
In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Študije in vitro kažejo, da ima vismodegib zmožnost, da deluje kot zaviralec beljakovine BCRP
Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Acute Generalised Exanthematous Pustulosis (AGEP)******
Stevens-Johnsonov sindrom (SJS) / toksična epidermalna nekroliza (TEN), reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) in akutna generalizirana eksantemska pustuloza (AGEP)******
A post-approval, open-label, non-comparative, multicenter, phase II clinical trial (MO25616) was conducted in 1232 patients with advanced BCC, of whom 1215 patients were evaluable for efficacy and safety with laBCC (n = 1119) or mBCC (n = 96).
Odprto, multicentrično preskušanje faze II brez primerjalne skupine (MO25616), ki je bilo zaveza pri pridobitvi dovoljenja za promet z zdravilom, je potekalo pri 1232 bolnikih z napredovalim bazalnoceličnim karcinomom, od tega so učinkovitost in varnost lahko ocenili pri 1215 bolnikih z lokalno napredovalim bazalnoceličnim karcinomom (n = 1119) ali metastatskim bazalnoceličnim karcinomom (n = 96).
If you are able to become pregnant:
Če obstaja možnost, da bi zanosili:
• To return unused capsules at the end of the treatment (disposal will depend on local requirements)
• Vrniti neporabljene kapsule po zaključku zdravljenja (odstranjevanje zdravila je odvisno od lokalnih zahtev).
The initial prescription and dispensing of Erivedge should occur within a maximum of 7 days of a negative pregnancy test (day of pregnancy test = day 1).
Omejitve za predpisovanje in izdajanje zdravila ženskam v rodni dobi Prvo predpisovanje in izdaja zdravila Erivedge morata biti opravljena v največ 7 dneh po negativnem testu nosečnosti (dan testa nosečnosti = dan 1).
Results from a clinical study demonstrated a 33% decrease in vismodegib unbound drug concentrations after 7 days co-treatment with 20 mg rabeprazole (a proton pump inhibitor) given 2 h before each vismodegib administration.
Izsledki klinične študije so pokazali 33-% zmanjšanje koncentracij nevezanega vismodegiba po 7 dneh sočasnega zdravljenja z 20 mg rabeprazola (zaviralca protonske črpalke), danega 2 uri pred vsakim dajanjem vismodegiba.
What Erivedge looks like and contents of the pack The capsules have a pink opaque coloured body marked “150 mg” and a grey cap marked "VISMO” in black edible ink.
Izgled zdravila Erivedge in vsebina pakiranja Kapsule imajo neprozorno telo rožnate barve z oznako "150 mg" in siv pokrovček, na katerem je s črnim užitnim črnilom izpisana oznaka "VISMO".
The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
Ocenjeni navidezni razpolovni čas vismodegiba v stanju dinamičnega ravnovesja je pri neprekinjeni vsakodnevni uporabi 4 dni.
A patient was considered a responder in the laBCC cohort if at least one of the following criteria was met and the patient did not experience progression: (1) ≥ 30 % reduction in lesion size [sum of the longest diameter (SLD)], from baseline in target lesions by radiography; (2) ≥ 30 % reduction in SLD from baseline in externally visible dimension of target lesions; (3) Complete resolution of ulceration in all target lesions.
Za bolnika v kohorti z lokalno napredovalim bazalnoceličnim karcinomom je veljalo, da se je odzval, če je izpolnjeval vsaj eno od naslednjih meril in njegova bolezen ni napredovala: (1) ≥ 30-% zmanjšanje velikosti ciljnih lezij [seštevek najdaljših premerov (SLD - sum of the longest diameter)] od izhodišča na podlagi radiografije, (2) ≥ 30-% zmanjšanje seštevka najdaljših premerov na zunaj vidnih dimenzij ciljnih lezij od izhodišča, (3) popolna izginitev ulceracij na vseh ciljnih lezijah.
• The need for monthly pregnancy tests even if the patient has amenorrhoea
• potrebo po opravljanju mesečnih testov nosečnosti, tudi če ima bolnica amenorejo
Not known (cannot be estimated from the available data).
Neznana (ni mogoče oceniti iz razpoložljivih podatkov) V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni »brez natrija«.
When vismodegib is administered with CYP inducers (rifampicin, carbamazepine, phenytoin, St. John´s wort), exposure to vismodegib may be decreased (see sections 4.3 and 4.4).
Ko damo vismodegib s spodbujevalci CYP (rifampicin, karbamazepin, fenitoin, šentjanževka), se lahko izpostavljenost vismodegibu zmanjša (glejte poglavji 4.3 in 4.4).
Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG).
Vismodegib se veže tako na albumin kot na alfa-1-kisli glikoprotein (AAG - alpha-1-acid glycoprotein) v človeškem serumu.
Patients with advanced BCC have an increased risk of developing cuSCC.
Bolniki z napredovalim bazalnoceličnim karcinomom imajo povečano tveganje za razvoj ploščatoceličnega karcinoma kože.
On the basis of the scientific conclusions for vismodegib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vismodegib is unchanged subject to the proposed changes to the product information.
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za vismodegib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo vismodegib, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca, odgovornega za sproščanje serij Roche Pharma AG
• The need to contact the healthcare professional immediately if a pregnancy is suspected during treatment or in the 24 months following treatment
• potrebo po takojšnjem kontaktiranju zdravstvenega delavca, če sumijo na nosečnost med zdravljenjem ali v 24 mesecih po zaključku zdravljenja
• St. John's wort (Hypericum perforatum) - a herbal medicine used for depression, since you must not use it at the same time as Erivedge.
• šentjanževko (Hypericum perforatum) - zeliščno zdravilo, ki se uporablja za zdravljenje depresije, ker je ne smete jemati, med tem ko se zdravite z zdravilom Erivedge.
• Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes.
• Rdečkaste, tarčam podobne lise ali okrogle zaplate na trupu pogosto z mehurčki v njihovem središču, luščenje kože, razjede v ustih, grlu, nosu, na genitalijah in očeh; preden se pojavijo,
Very limited data is available in patients with severe renal impairments.
Na voljo je zelo malo podatkov o bolnikih s hudo ledvično okvaro.
• has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
• je imela menstruacijo kadarkoli v zadnjih 12 zaporednih mesecih, • ni opravila histerektomije ali obojestranske ooforektomije ter nima medicinsko potrjene trajne prezgodnje odpovedi jajčnikov,
Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma.
Zdravilo Erivedge uporabljamo za zdravljenje odraslih, ki imajo posebno vrsto kožnega raka, imenovano napredovali bazalnocelični karcinom.
Decreased haematocrit or platelet count were observed in some dogs at clinically relevant exposures; however, there was no evidence of a primary effect on bone marrow in affected animals.
Pri nekaterih psih so ob klinično pomembnih izpostavljenostih zabeležili znižanje hematokrita ali števila trombocitov, vendar pri prizadetih živalih niso ugotovili primarnega vpliva na kostni mozeg.
Effects of concomitant medicinal products on vismodegib
Vplivi sočasno danih zdravil na vismodegib
PD = progressive disease, SD = stable disease, R = response, * = complete resolution of ulceration(s).
NB = napredovanje bolezni, SB = stabilna bolezen, O = odziv, * = popolna izginitev ulceracij(e).
NE = not estimable * Efficacy-evaluable patient population is defined as all enrolled patients who received any amount of Erivedge and for whom the independent pathologist's interpretation of archival tissue or baseline biopsy was consistent with BCC.
* Kot populacija bolnikov, primernih za oceno učinkovitosti, so opredeljeni vsi vključeni bolniki, ki so prejeli kakršno koli količino zdravila Erivedge in pri katerih se je ocena arhiviranega tkiva ali izhodiščne biopsije po pregledu neodvisnega patologa skladala z diagnozo bazalnoceličnega karcinoma.
• Bones stop growing (epiphyses premature fusion)
• prenehanje rasti kosti (prezgodnje zraščanje epifiz),
• hair loss (alopecia),
• driska, • izpadanje las (alopecija),
Erivedge contains lactose and sodium
Zdravilo Erivedge vsebuje laktozo in natrij
Dysgeusia Ageusia
Bolezni živčevja disgevzija agevzija hipogevzija
• National or other applicable specific arrangements for a prescription for Erivedge to be dispensed
• Nacionalna ali druga ustrezna posebna navodila glede predpisovanja in izdajanja zdravila
It is not known if Erivedge can pass into your breast milk and harm your baby.
Ni namreč znano, ali lahko zdravilo Erivedge prehaja v materino mleko in škoduje otroku;
For women taking Erivedge
Za ženske, ki jemljejo zdravilo Erivedge
• Pregnancy reporting form
• obrazec za poročanje nosečnosti
They are available in bottles with a child-resistant closure containing 28 capsules.
Na voljo so v plastenkah z za otroke varno zaporko, ki vsebujejo po 28 kapsul.
Malformations, including craniofacial anomalies, open perineum, and absent and/or fused digits, were observed in foetuses of dams at a dose which corresponded to 20 % of the typical steady-state exposure in patients, and a 100 % incidence of embryolethality was observed at higher doses.
Malformacije (vključno s kraniofacialnimi malformacijami, odprtim perinejem in odsotnostjo in/ali zraščenostjo prstov) so opažali pri plodovih samic v odmerkih, ki so ustrezali 20 % tipične izpostavljenosti v stanju dinamičnega ravnovesja pri bolnikih, pri večjih odmerkih pa so zabeležili
It may not be excluded that vismodegib may give rise to increased exposure of medicinal products transported by this protein, such as rosuvastatin, topotecan, and sulfasalazin.
Podatkov in vivo o medsebojnem delovanju ni. Ni mogoče izključiti, da lahko vismodegib povzroči povečano izpostavitev zdravilom, ki se prenašajo s to beljakovino, kot so rosuvastatin, topotekan in sulfasalazin.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
• Serious skin reactions have been reported in association with Erivedge treatment.
• V povezavi z zdravljenjem z zdravilom Erivedge so poročali o resnih kožnih reakcijah.
• Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate.
• vsebina kapsule: mikrokristalna celuloza, laktoza monohidrat, natrijev lavrilsulfat, povidon (K29/32), natrijev karboksimetilškrob (vrsta A), smukec in magnezijev stearat;
No dose adjustment is required in patients with mild, moderate or severe hepatic impairment defined based on National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG)- criteria for hepatic impairment:
Jetrna okvara Odmerka ni treba prilagoditi bolnikom z blago, zmerno ali hudo jetrno okvaro glede na merila NCIODWG (National Cancer Institute Organ Dysfunction Working Group) za jetrno okvaro:
*Of the 138 patients with advanced BCC, 10 were WCBP.
*Od 138 oseb z napredovalim bazalnoceličnim karcinomom je bilo 10 žensk v rodni dobi.
The most common adverse drug reactions (ADR) occurring in ≥ 30 % of patients, were muscle spasms (74.6 %), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8 %) and diarrhea (33.3%).
(74,6 %), alopecija (65,9 %), dizgevzija (58,7 %), zmanjšanje telesne mase (50,0 %), utrujenost (47,1 %), navzea (34,8 %) in driska (33,3 %).
How to take Erivedge
Kako jemati zdravilo Erivedge
• Erivedge exposes a teratogenic risk to the unborn child,
• zdravilo Erivedge predstavlja tveganje za teratogenost pri še nerojenem otroku;
Erivedge or during the 2 months after his final dose.
Erivedge ali v 2 mesecih po njegovem zadnjem odmerku tega zdravila.
No malignant tumors were identified in either species tested.
Pri nobeni vrsti v preskušanju niso ugotovili malignih tumorjev.
Patients who present with amenorrhoea during treatment with Erivedge should continue monthly pregnancy testing while on treatment.
Bolnice, ki dobijo amenorejo med zdravljenjem z zdravilom Erivedge, morajo s testi nosečnosti nadaljevati vsak mesec medtem, ko se zdravijo.
Upon continuous daily dosing, there is a 3 fold accumulation of vismodegib total plasma concentrations.
Akumulacija je pri neprekinjeni vsakodnevni uporabi 3-kratna celokupni plazemski koncentraciji vismodegiba.
A WCBP must understand that:
Ženska v rodni dobi mora razumeti, da:
• upset stomach or indigestion,
• razdražen želodec ali prebavne motnje,
39 months follow-up after last patient enrolled): efficacy-evaluable patients*,†
Izidi učinkovitosti zdravila Erivedge (ocena IRF po 21 mesecih in raziskovalca po 39 mesecih spremljanja po vključitvi zadnjega bolnika): bolniki, primerni za oceno učinkovitosti*
LaBCC patients had cutaneous lesions that were inappropriate for surgery (inoperable, multiply recurrent where curative resection deemed to be unlikely or for whom surgery would result in substantial deformity or morbidity) and for which radiotherapy was unsuccessful or contraindicated or inappropriate.
Bolniki z lokalno napredovalim bazalnoceličnim karcinomom so imeli kožne spremembe, ki niso bile primerne za operacijo (neoperabilne, večkratno ponovljene, kjer je bilo ocenjeno, da kurativna resekcija ni verjetna, ali kjer bi operacija povzročila bistveno deformacijo ali obolevnost), in pri katerih radioterapija ni bila uspešna, je bila kontraindicirana ali neprimerna.
Taking into account the PRAC Assessment Report on the PSUR(s) for vismodegib, the scientific conclusions of the CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za vismodegib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
• The need to refer the patient to a specialist physician
• bolnika je treba napotiti k zdravniku specialistu
*** Observed in patients during a post-approval study with 1215 safety evaluable patients.
***Opaženo pri bolnikih v študiji, ki je bila zaveza pri pridobitvi dovoljenja za promet, z vključenimi 1215
Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
Popolni odziv je doseglo 4,8 % bolnikov v kohorti z metastatskim bazalnoceličnim karcinomom in 33,4 % bolnikov v kohorti z lokalno napredovalim bazalnoceličnim karcinomom.
All reporting is based on ADRs of all grades using National Cancer Institute - Common Terminology Criteria for Adverse Events v 3.0 except where noted.
Institute - Common Terminology Criteria for Adverse Events) v3.0, razen kjer je označeno.
• Remind patients to return unused capsules at the end of the treatment (disposal will depend on local requirements)
• Opozoriti bolnika, da vrne neporabljenje kapsule po končanem zdravljenju (ravnanje z zdravilom je odvisno od lokalnih zahtev)
It is not known if SCC is related to treatment with Erivedge.
Ne vemo, ali je njegov nastanek povezan z zdravljenjem z zdravilom Erivedge.
In a clinical study in patients with hepatic impairment (degree of impairment based on subject's AST and total bilirubin levels) following multiple doses of vismodegib, it was shown that in patients with mild (NCI-ODWG criteria, n=8), moderate (NCI-ODWG criteria, n=6), and severe (NCI-ODWG criteria, n=3) hepatic impairment, the pharmacokinetic profile of vismodegib was comparable to that of subjects with normal hepatic function (n=9) (see section 4.2).
klinični študiji pri bolnikih z jetrno okvaro (stopnja okvare je temeljila na vrednosti posameznikove aspartat aminotransferaze (AST) in celokupne ravni bilirubina) so imeli po večkratnih odmerkih vismodegiba bolniki z blago (merila NCI-ODWG, n = 8), zmerno (merila NCI-ODWG, n = 6) in hudo (merila NCI-ODWG, n = 3) jetrno okvaro farmakokinetični profil vismodegiba primerljiv s profilom vismodegiba pri posameznikih z normalnim delovanjem jeter (n = 9) (glejte poglavje 4.2).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule contents
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
In case of pregnancy in a woman treated with Erivedge, treatment must be stopped immediately.
Če bolnica med zdravljenjem z zdravilom Erivedge zanosi, je treba zdravljenje nemudoma ustaviti.
LaBCC was defined as cutaneous lesions that were inappropriate for surgery (inoperable, or for whom surgery would result in substantial deformity) and for which radiotherapy was unsuccessful or contraindicated.
Lokalno napredovali bazalnocelični karcinom so opredelili kot kožne spremembe, ki niso primerne za operacijo (neoperabilne ali take, pri katerih bi operacija povzročila občutno deformacijo), in pri katerih radioterapija ni bila uspešna ali je kontraindicirana.
In case of pregnancy or missed menstrual periods If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.
Če bolnica zanosi, ji izostane menstruacija, ali iz kakšnega drugega razloga sumi, da bi lahko bila noseča, mora o tem nemudoma obvestiti svojega lečečega zdravnika.
In addition, the ratio of organ weight to terminal body weight was significantly increased for epididymis, cauda epididymis, testes and seminal vesicles.
Dodatno je bilo razmerje med maso organa in maso celotnega telesa pomembno povečano za nadmodek, rep nadmodka, moda in semenske mešičke.
Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink.
Neprozorno rožnato telo z oznako "150 mg" in neprozoren siv pokrovček z oznako "VISMO",
****Individual cases have been reported in patients with medulloblastoma during post-marketing use (see section
****Pri bolnikih z meduloblastomom so po prihodu zdravila na trg poročali o posameznih primerih (glejte poglavje 4.4).
The safety of Erivedge has been evaluated in clinical trials with 138 patients treated for advanced basal cell carcinoma (aBCC), which includes both metastatic BCC (mBCC) and locally advanced BCC (laBCC).
Varnost zdravila Erivedge so ocenili v kliničnih preskušanjih s 138 bolniki, zdravljenimi zaradi napredovalega bazalnoceličnega karcinoma, ki vključuje metastatski bazalnocelični karcinom in lokalno napredovali bazalnocelični karcinom.
Median Duration of Response (months) (95 % CI)
Mediana trajanja odziva (meseci) (95-% interval zaupanja)
• Safety advice for women of childbearing potential
• Varnostni nasveti za ženske v rodni dobi
Among patients in the efficacy-evaluable population with measurable and histologically confirmed disease, 68.5% and 36.9% responded to treatment in the laBCC and mBCC cohorts, respectively, by RECIST v1.1.
Med bolniki z merljivo in histološko potrjeno boleznijo, ki so bili primerni za oceno učinkovitosti, se jih je glede na merila RECIST v1.1 v kohorti z lokalno napredovalim bazalnoceličnim karcinomom na zdravljenje odzvalo 68,5 %, v kohorti z metastatskim bazalnoceličnim karcinomom pa 36,9 %.
WCBP, whose periods are irregular or stopped, must follow all the advice on effective contraception.
Ženske v rodni dobi, ki imajo neredne menstruacije ali jih nimajo, morajo upoštevati vse zahteve za učinkovito kontracepcijo.