FrancophonIA/ELRC3.0 huggingface dataset:
English: Female patients must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose (see section 4.6).
Estonian: Naissoost patsiendid peavad Erivedge-ravi ajal ja 24 kuu jooksul pärast viimase annuse manustamist kasutama kahte soovitatud rasestumisvastast meetodit, sealhulgas ühte väga efektiivset meetodit ja barjäärimeetodit (vt lõik 4.6).
English: • If you are male, you should not donate semen at any time during treatment and for 2 months after the final dose.
Estonian: • Kui te olete mees, ei tohi te doonorina spermat loovutada mis tahes ajal ravi jooksul ja 2 kuud pärast viimase annuse manustamist.
English: Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
Estonian: Must raudoksiid (E172) Punane raudoksiid (E172) Titaandioksiid (E171)
English: The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Estonian: Vismodegiibi põhilised eliminatsiooni teed on maksas toimuv metabolism ja sekretsioon sappi/soolde.
English: Read the specific instructions given to you by your doctor, particularly on the effects of Erivedge on unborn babies.
Estonian: Mida on vaja teada enne Erivedge võtmist Lugege arstilt saadud erijuhised, eriti Erivedge toime kohta veel sündimata lapsele.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Estonian: Ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, st on praktiliselt naatriumivaba.
English: In a WCBP, a medically supervised pregnancy test, conducted by a heath care provider, should be performed within 7 days prior to initiating treatment and monthly during treatment.
Estonian: Rasestuda võivale naisele tuleb tervishoiutöötaja poolt tehtav meditsiiniliselt kontrollitud rasedustest teha 7 päeva jooksul enne ravi alustamist ja ravi ajal kord kuus.
English: 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).
Estonian: Erivedge ohutust on hinnatud kliinilistes uuringutes, mille käigus said kaugelearenenud basaalrakkkartsinoomi (mis hõlmab nii metastaatilist kui lokaalselt kaugelearenenud basaalrakk-kartsinoomi) ravi 138 patsienti.
English: The patient educational material for Erivedge should contain the following key elements:
Estonian: Erivedge patsiendi teabematerjal peab sisaldama järgmisi põhielemente:
English: She must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose.
Estonian: Ta peab Erivedge-ravi ajal ja 24 kuu jooksul pärast viimase annuse manustamist kasutama kahte soovitatud rasestumisvastast meetodit, sealhulgas ühte väga efektiivset meetodit ja barjäärimeetodit.
English: You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
Estonian: Te peate ravi ajal või 24 kuu jooksul pärast selle ravimi viimase annuse manustamist teavitama oma arsti otsekohe sellest, kui:
English: *Of the 138 patients with advanced BCC, 10 were WCBP.
Estonian: *138-st kaugelearenenud basaalrakk-kartsinoomiga patsiendist 10 olid rasestuda võivad naised.
English: In general the safety profile observed was consistent in both mBCC and laBCC patients and across studies as described below.
Estonian: Üldiselt täheldati nii metastaatilise kui lokaalselt kaugelearenenud basaalrakk-kartsinoomiga patsientidel ning uuringute lõikes ühesugust ohutusprofiili, nagu on kirjeldatud allpool.
English: According to investigator assessment, the median time to maximum tumour reduction occurred in 6.7 and 5.5 months for laBCC and mBCC patients respectively.
Estonian: Uurija hinnangul oli keskmine aeg kasvaja suuruse maksimaalse vähenemiseni 6,7 ja 5,5 kuud vastavalt lokaalselt kaugelearenenud ja metastaatilise basaalrakulise kartsinoomiga patsientidel.
English: • Vasectomy,
Estonian: • vasektoomia,
English: Erivedge is unlikely to affect your ability to drive, use any tools or machines.
Estonian: Erivedge ei mõjuta tõenäoliselt autojuhtimise või masinatega töötamise võimet.
English: How to take Erivedge
Estonian: Kuidas Erivedge't võtta
English: • Serious skin reactions have been reported in association with Erivedge treatment.
Estonian: • Seoses Erivedge raviga on teatatud tõsistest nahareaktsioonidest.
English: Any unused medicinal product at the end of treatment must immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to the pharmacist or physician).
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks Kasutamata ravimpreparaat tuleb ravi lõppedes otsekohe hävitada vastavalt kohalikele nõuetele (nt võimalusel peab patsient tagastama kapslid apteekrile või arstile).
English: WCBP must be able to comply with effective contraceptive measures.
Estonian: Rasestuda võiv naine peab olema võimeline järgima efektiivseid rasestumisvastaseid meetmeid.
English: • The healthcare professional should report confirmed pregnancies to the MAH
Estonian: • Tervishoiutöötaja peab kinnitatud rasedustest teavitama müügiloa hoidjat
English: • She must tell her healthcare provider if any of the following occur during treatment and for 24 months after her final dose:
Estonian: • ta peab oma tervishoiutöötajat teavitama sellest, kui ravi ajal või 24 kuu jooksul pärast viimase annuse manustamist leiab aset midagi järgnevalt loetletust:
English: • The need to keep Erivedge capsules out of sight and reach of children
Estonian: • Vajadus hoida Erivedge kapsleid laste eest varjatud ja kättesaamatus kohas
English: • Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
Estonian: Nõuded asjaomase ravimi perioodiliste ohutusaruannete esitamiseks on sätestatud direktiivi 2001/83/EÜ artikli 107c punkti 7 kohaselt liidu kontrollpäevade loetelus (EURD loetelu) ja iga hilisem uuendus avaldatakse Euroopa ravimite veebiportaalis.
English: 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.
Estonian: Lokaalselt kaugelearenenud basaalrakulise kartsinoomiga patsientidel esinesid nahakolded, mille puhul oli kirurgiline ravi sobimatu (mitteopereeritav, lokaalselt retsidiveerunud kasvaja, mille puhul kuratiivset resektsiooni peeti ebatõenäoliseks või kellel operatsiooni tulemuseks oleks märkimisväärne deformatsioon või haigusseisund) ning kiiritusravi ebaedukas või vastunäidustatud või sobimatu.
English: • The need to refer the patient to a specialist physician
Estonian: • Vajadus suunata patsient arst-spetsialisti konsultatsioonile
English: After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Estonian: Pärast pidevat üks kord päevas manustamist on vismodegiibi farmakokineetika mittelineaarne küllastuva imendumise ja küllastuva valkudega seonduvuse tõttu.
English: • That the patient should tell the healthcare professional about any adverse event
Estonian: • Patsient peab teavitama tervishoiutöötajat võimalikest kõrvaltoimetest
English: Figure 2 SHH4476g Locally Advanced BCC Cohort
Estonian: Joonis 2 SHH4476g lokaalselt kaugelearenenud basaalrakulise kartsinoomi kohort
English: • 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.
Estonian: • kui te olete rase, arvate end olevat rase või kavatsete rasestuda ravi ajal või 24 kuu jooksul pärast selle ravimi viimase annuse manustamist.
English: • does not have a XY genotype, Turner's syndrome, or uterine agenesis,
Estonian: • kellel ei ole XY-genotüüpi, Turneri sündroomi või emaka ageneesi, • kellel tekib amenorröa vähiravi, sh Erivedge-ravi järgselt.
English: Therefore, Erivedge may be taken without regard to meals.
Estonian: Seetõttu võib ravimit manustada söögiaegadest sõltumatult.
English: Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to Erivedge.
Estonian: Erivedge't saanud pediaatrilistel patsientidel on kirjeldatud epifüüside enneaegset sulgumist ja enneaegset puberteeti.
English: • The need for adequate contraceptive measures (even if the woman has amenorrhoea) during treatment and for 24 months after Erivedge treatment
Estonian: • Vajadus kasutada piisavaid rasestumisvastaseid meetmeid (isegi kui naisel on amenorröa) ravi ajal ja 24 kuud pärast Erivedge-ravi
English: • muscle, tendon, ligament, bone pain,
Estonian: • lihas-, kõõlus-, sideme-, luuvalu,
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,
Estonian: • ravi jooksul kord kuus tehtav rasedustest peab andma negatiivse vastuse, isegi kui on tekkinud amenorröa,
English: • Distribution of the product
Estonian: • Toote turustamine
English: • The need for adequate contraceptive measures during treatment and for 24 months after Erivedge treatment
Estonian: • Vajadus kasutada piisavaid rasestumisvastaseid meetmeid ravi ajal ja 24 kuud pärast Erivedge-ravi
English: Programme (see sections 4.4 and 4.6).
Estonian: ja 4.6).
English: It has not been determined whether cuSCC is related to Erivedge treatment.
Estonian: Pole kindlaks tehtud, kas naha lamerakk-kartsinoom on seotud Erivedge-raviga.
English: Hedgehog pathway inhibitors, (see section 5.1) such as vismodegib, have been demonstrated to be embryotoxic and/or teratogenic in multiple animal species and can cause severe malformations, including craniofacial anomalies, midline defects and limb defects (see section 5.3).
Estonian: Hedgehogi raja inhibiitorid (vt lõik 5.1) nagu vismodegiib on paljudel loomaliikidel olnud embrüotoksilised ja/või teratogeensed ning võivad põhjustada raskeid väärarenguid, kaasa arvatud näokolju arenguhäireid, neuraaltoru sulgumise defekte ja jäsemete väärarenguid (vt lõik 5.3).
English: However, irreversible defects in growing teeth and premature closure of the femoral epiphyseal plate, observed in rat toxicity studies at clinically relevant exposures, represent risks to post-natal development.
Estonian: Kuid ohtu postnataalsele arengule näitavad kasvavate hammaste pöördumatud defektid ja reieluu epifüüsiplaadi enneaegne sulgumine, mida täheldati rottide toksilisuse uuringutes kliiniliselt oluliste kontsentratsiooni väärtuste puhul.
English: Carcinogenic potential was identified in rats only and was limited to benign hair follicle tumors, including pilomatricomas and keratoacanthomas respectively at ≥ 0.1-fold and ≥0.6-fold of the steady-state AUC(0-24h) of the recommended human dose.
Estonian: Kartsinogeenne potentsiaal tuvastati ainult rottidel ja see piirdus healoomuliste karvafolliikuli kasvajatega, sealhulgas pilomatrikoomide ja keratoakantoomidega püsiseisundi AUC(0...24h) väärtuste juures, mis olid vastavalt ≥ 0,1 korda ja
English: • The need to contact the healthcare professional if the female partner suspects that she is pregnant while the patient is treated with Erivedge or in the 2 months following treatment
Estonian: • Vajadus kontakteeruda tervishoiutöötajaga juhul, kui naissoost partner kahtlustab rasedust ajal, mil patsient saab ravi Erivedge'ga või 2 kuu jooksul pärast ravi
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Estonian: Kaugelearenenud basaalrakk-kartsinoomiga patsientidel on suurem risk naha lamerakk-kartsinoomi tekkeks.
English: 4.1 Therapeutic indication
Estonian: 4.1 Näidustused
English: In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
Estonian: Lokaalselt kaugelearenenud basaalrakulise kartsinoomi kohordis hinnati kasvaja ravile reageerimist välise tuumori ja haavandumise visuaalse hindamise, kasvaja piltdiagnostika (võimalusel) ja biopsia alusel.
English: How to store Erivedge
Estonian: Kuidas Erivedge't säilitada
English: There was no evidence of genotoxicity in in vitro assays (reverse bacterial mutagenesis [Ames] and human lymphocyte chromosome aberration assays) or in the in vivo rat bone marrow micronucleus assay.
Estonian: In vitro testides (bakteriaalse mutageneesi [Ames] ja inimese lümfotsüütide kromosoomiaberratsiooni testid) ning in vivo rottide luuüdi mikrotuumade testis genotoksilisuse ilminguid ei täheldatud.
English: To avoid potential foetal exposure during pregnancy, male patients must always use a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose.
Estonian: Vältimaks loote võimalikku kokkupuudet ravimiga raseduse ajal, peavad meessoost patsiendid Erivedge-ravi ajal ja 2 kuu jooksul pärast viimase annuse manustamist kasutama alati kondoomi (võimalusel koos spermitsiidiga), isegi pärast vasektoomiat, kui on seksuaalvahekorras naispartneriga.
English: Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Estonian: Kliinilisele olukorrale vastavates tingimustes (püsiseisund) ei mõjuta toit vismodegiibi farmakokineetikat.
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Estonian: Alustades toote turustamist saadab müügiloa hoidja laiali tervishoiutöötajatele suunatud kirja, mis sisaldab järgmist:
English: However, results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) is not altered when co-administered with vismodegib.
Estonian: Kuid vähihaigetel läbi viidud ravimite koostoimeuuringu tulemused näitasid, et koos vismodegiibiga manustamisel ei muutunud rosiglitasooni (CYP2C8 substraat) süsteemne kontsentratsioon.
English: Patients were treated with oral daily dosing of Erivedge at 150 mg.
Estonian: Patsiendid said ravi Erivedge'ga suukaudses ööpäevases annuses 150 mg.
English: The exposure in female rats at 100 mg/kg corresponds to 1.2-fold of the steady-state AUC0-24h at the recommended human dose.
Estonian: Emasloomadel oli 100 mg/kg ööpäevas manustamisel ravimi ekspositsioon 1,2 korda suurem inimestele soovitatava annuse kasutamisel saavutatavatest tasakaaluseisundi AUC0-24h väärtustest).
English: Criteria for a woman of childbearing potential (WCBP) A WCBP is defined in the Erivedge Pregnancy Prevention Programme as:
Estonian: Rasestuda võiva naise kriteeriumid Erivedge raseduse vältimise programmis määratletakse rasestuda võivat naist kui:
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Estonian: Pidage kapslite tagastamise osas nõu oma arsti või apteekriga.
English: Median Progression Free survival (months) (95 % CI)
Estonian: Keskmine progressioonivaba elulemus (kuud) (95 % CI)
English: In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Estonian: Toime spetsiifilistele ensüümidele ja transporteritele In vitro uuringud näitavad, et vismodegiib võib toimida rinnavähi resistentsusvalgu (BCRP) inhibiitorina.
English: • The need for the patient to report a suspected pregnancy immediately to the treating healthcare professional
Estonian: • Patsiendi kohustus teatada raseduse kahtlusest otsekohe raviarstile
English: • a diaphragm (with spermicide, if available).
Estonian: • diafragma (võimalusel koos spermitsiidiga).
English: • Premature puberty (precocious puberty)
Estonian: • enneaegne puberteet
English: Severe cutaneous adverse reactions (SCARs) including cases of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during post-marketing use (see section 4.8).
Estonian: Turuletulekujärgsel kasutamisel on teatatud rasketest nahareaktsioonidest (severe cutaneous adverse reactions, SCAR-id), sealhulgas Stevensi-Johnsoni sündroomi/toksilise epidermaalse nekrolüüsi (SJS/TEN), eosinofiilia ja süsteemsete sümptomitega ravimireaktsiooni (drug reaction with eosinophilia and systemic symptoms, DRESS) ja ägeda generaliseerunud eksantematoosse pustuloosi (acute generalised exanthematous pustulosis, AGEP) juhtudest, mis võivad olla eluohtlikud (vt lõik 4.8).
English: They are available in bottles with a child-resistant closure containing 28 capsules.
Estonian: Lastekindla korgiga pudelis on 28 kapslit.
English: Table 1 ADRs occurring in patients treated with Erivedge MedDRA SOC Very common
Estonian: Tabel 1 Erivedge'ga ravitud patsientidel täheldatud kõrvaltoimed MedDRA organsüsteemi klass
English: Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
Estonian: Mikrokristalliline tselluloos Laktoosmonohüdraat Naatriumlaurüülsulfaat Povidoon (K29/32) Naatriumtärklisglükolaat (tüüp A) Talk
English: Erivedge is contraindicated in WCBP who do not comply with the Erivedge Pregnancy Prevention Programme.
Estonian: Erivedge on vastunäidustatud rasestuda võivatel naistel, kes ei järgi Erivedge raseduse vältimise programmi.
English: Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway.
Estonian: Vismodegiib on suu kaudu manustatav Hedgehogi raja väikesemolekuliline inhibiitor.
English: Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Estonian: Erivedge't tohib määrata ja ravi peab toimuma ainult vastava haiguse ravikogemusega spetsialisti järelevalve all.
English: • She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
Estonian: • 7 päeva jooksul enne Erivedge-ravi alustamist tervishoiutöötaja poolt tehtud rasedustest peab andma negatiivse vastuse,
English: No increases in plasma vismodegib levels or toxicity were observed during these clinical trials.
Estonian: Nendes kliinilistes uuringutes ei täheldatud vismodegiibi plasmakontsentratsiooni suurenemist ega toksilisust.
English: • Information for patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Estonian: • Teave patsientidele Erivedge'ga seotud teratogeensete riskide ja vajaduse kohta vältida loote kokkupuudet ravimiga
English: • Any male condom (with spermicide, if available),
Estonian: • mehe kondoom (võimalusel koos spermitsiidiga),
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of vismodegib.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 150 mg vismodegiibi.
English: Common ( ≥ 1/100 to < 1/10)
Estonian: Sage (≥ 1/100 kuni < 1/10)
English: Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Estonian: Vismodegiibi eliminatsioon on aeglane, toimudes metabolismi ja muutumatul kujul ravimi eritumise teel.
English: For health care providers (HCP)
Estonian: Tervishoiutöötajatele
English: • The need to use condoms when having sex with a female partner during treatment and for 2 months after Erivedge treatment
Estonian: • Vajadus kasutada kondoomi, kui on seksuaalvahekorras naispartneriga, ravi ajal ja 2 kuud pärast Erivedge-ravi
English: Prior to study enrolment, diagnosis of BCC was confirmed by histology.
Estonian: Enne uuringusse kaasamist kinnitati basaalrakk-kartsinoomi diagnoos histoloogiliselt.
English: • carbamazepine, phenytoin - used for epilepsy,
Estonian: • karbamasepiin, fenütoiin - epilepsiaravimid,
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Estonian: • Tagastada kasutamata jäänud kapslid ravi lõppedes (hävitamine sõltub kohalikest nõuetest) Telefoninumbrid kontakteerumiseks hädaolukorras
English: The extent to which vismodegib is excreted in breast milk is not known.
Estonian: Vismodegiibi rinnapiima eritumise ulatus ei ole teada.
English: • The need for the patient to report immediately to the treating healthcare professional if his partner becomes pregnant whilst he is taking Erivedge or shortly after he has stopped taking Erivedge
Estonian: • Patsiendi kohustus teavitada raviarsti otsekohe sellest, kui tema partner rasestub ajal, mil ta kasutab Erivedge't või vahetult pärast Erivedge-ravi lõpetamist
English: The patient reminder card should contain the following key elements:
Estonian: Patsiendi meelespeakaart peab sisaldama järgmisi põhielemente
English: Additionally, amenorrhoea has been observed in clinical trials in WCBP (see section 4.8).
Estonian: Lisaks on kliinilistes uuringutes täheldatud rasestuda võivatel naistel amenorröad (vt lõik 4.8).
English: • A requirement to inform patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Estonian: • Nõue teavitada patsiente Erivedge'ga seotud teratogeensetest riskidest ja vajadus vältida loote kokkupuudet ravimiga
English: • The need to use condoms (even if the man has had a vasectomy) if his sexual partner is pregnant or a women of childbearing potential during treatment and for 2 months after Erivedge treatment
Estonian: • Vajadus kasutada kondoomi (isegi kui mehele on tehtud vasektoomia), kui tema seksuaalpartner on rase või rasestuda võiv naine, ravi ajal ja 2 kuud pärast Erivedge-ravi
English: Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of ethinyl estradiol and norethindrone is not altered when co-administered with vismodegib.
Estonian: Vähihaigetel läbi viidud ravimite koostoimeuuringud näitasid, et koos vismodegiibiga manustamisel ei muutunud etinüülöstradiooli ja noretindrooni süsteemne kontsentratsioon .
English: Prior to study enrollment, diagnosis of BCC was confirmed by histology.
Estonian: Enne uuringusse kaasamist kinnitati basaalrakulise kartsinoomi diagnoos histoloogiliselt.
English: • severe: 3 x ULN < TB < 10 x ULN, AST any
Estonian: • raske: 3 x ULN < TB < 10 x ULN, igasugune ASAT (vt lõik 5.2)
English: Seven cases of severe cutaneous adverse reactions (SCARs) have been reported in association with vismodegib cumulatively.
Estonian: Seoses vismodegiibi kasutamisega on kumulatiivselt teatatud seitsmest raske nahareaktsiooni (severe cutaneous adverse reactions, SCAR) juhust.
English: HDPE bottle with a child-resistant closure containing 28 hard capsules.
Estonian: 28 kõvakapslit sisaldav lastekindla korgiga HDPE pudel.
English: Do this during treatment and for 2 months after your final dose of this medicine.
Estonian: See on vajalik ravi ajal ja 2 kuu jooksul pärast selle ravimi viimase annuse manustamist.
English: Effects of concomitant medicinal products on vismodegib
Estonian: Samaaegselt kasutatavate ravimite toime vismodegiibile
English: • You should not donate blood at any time during treatment and for 24 months after your final dose of this medicine.
Estonian: • Te ei tohi doonorina verd anda mis tahes ajal ravi jooksul ja 24 kuud pärast selle ravimi viimase annuse manustamist.
English: Erivedge 150 mg hard capsules vismodegib
Estonian: Erivedge 150 mg kõvakapslid vismodegiib
English: The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
Estonian: Ravimi pideval igapäevasel manustamisel on vismodegiibi poolväärtusaeg püsiseisundi tingimustes hinnanguliselt 4 päeva.