natgillin/translations-raw huggingface dataset:
Drug induced liver injury*****
okvara jeter zaradi zdravil*****
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.
Kontraceptivni steroidi Izsledki študije medsebojnega delovanja zdravilo-zdravilo pri bolnikih z rakom so pokazali, da sistemska izpostavljenost etinilestradiolu in noretindronu ni spremenjena, ko ju dajemo sočasno z vismodegibom.
Fertility preservation strategies should be discussed with WCBP prior to starting treatment with Erivedge.
Z ženskami v rodni dobi se je treba pred začetkom zdravljenja z zdravilom Erivedge pogovoriti o strategijah za ohranitev plodnosti.
• If she needs to change contraception during treatment,
• mora med zdravljenjem zamenjati kontracepcijo;
Erivedge is contraindicated in WCBP who do not comply with the Erivedge Pregnancy Prevention Programme.
Zdravilo Erivedge je kontraindicirano pri ženskah v rodni dobi, ki ne upoštevajo Programa za preprečevanje nosečnosti med uporabo zdravila Erivedge.
In the dedicated 26-week vismodegib rat fertility study, vismodegib-related effects on female reproductive organs were observed at 100 mg/kg/day immediately after treatment discontinuation, including decreased implantations, increased percent preimplantation loss, and decreased number of dams with viable embryos.
V usmerjeni 26-tedenski študiji z vismodegibom, v kateri so preskušali plodnost na podganah, so pri odmerkih 100 mg/kg/dan takoj po prenehanju zdravljenja opazili z vismodegibom povezane učinke na reproduktivne organe samic, vključno z zmanjšano implantacijo, povečanim odstotkom izgub po implantaciji in zmanjšanim številom samic z zarodki, sposobnimi za preživetje.
Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and an uncommon pyridine ring cleavage.
Presnovne poti vismodegiba pri človeku vključujejo oksidacijo, glukuronidacijo in redko razcep piridinskega obroča.
The following are recommended forms of barrier methods:
Priporočene pregradne kontracepcijske metode so:
• Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide, gelatine,
• ovojnica kapsule: rdeči železov oksid (E 172), črni železov oksid (E 172), titanov dioksid, želatina;
Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
V klinično pomembnih okoliščinah (stanje dinamičnega ravnovesja) hrana ne vpliva na farmakokinetiko vismodegiba.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Investigator-Assessed mBCC (n = 33)
ocena raziskovalca metastatski bazalnocelični karcinom (n = 33)
• Do not use this medicine after the expiry date, which is stated on the bottle and carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Po končanem zdravljenju morajo bolniki neuporabljene kapsule takoj zavreči v skladu z lokalnimi predpisi (če je ustrezno, jih lahko npr. vrnejo farmacevtu ali zdravniku).
• muscle, tendon, ligament, bone pain,
• bolečine v mišicah, tetivah, vezeh, kosteh,
The European Medicines Agency has waived the obligation to submit the results of studies with Erivedge in all subsets of the paediatric population with basal cell carcinoma (see section 4.2 for information on paediatric use).
Erivedge za vse skupine pediatrične populacije z bazalnoceličnim karcinomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This is because Erivedge may harm or cause the death of your unborn baby.
Zdravilo Erivedge namreč lahko nerojenemu otroku škoduje ali povzroči, da umre;
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.
Izsledki študije medsebojnega delovanja pri bolnikih z rakom so pokazali, da se sistemska izpostavljenost rosiglitazonu (substrat CYP2C8) med sočasno uporabo z vismodegibom ne spremeni.
Due to safety concerns (see sections 4.4 and 5.3), this medicinal product should not be used in children and adolescents aged below 18 years.
Tega zdravila se zaradi pomislekov glede varnosti ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavji 4.4 in 5.3).
HDPE bottle with a child-resistant closure containing 28 hard capsules.
Plastenka z za otroke varno zaporko iz HDPE z 28 trdimi kapsulami.
• Erivedge exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman,
mora moški razumeti, da: • zdravilo Erivedge predstavlja tveganje za teratogenost pri še nerojenem otroku, če ima nezaščitene spolne odnose z nosečo žensko;
The patient educational material for Erivedge should contain the following key elements:
Izobraževalno gradivo za bolnika za zdravilo Erivedge mora vsebovati naslednje ključne elemente:
1-year survival rate (95 % CI)
1-letno preživetje (95-% interval zaupanja) N.o.
Precocious puberty****
Bolezni endokrinega sistema prezgodnja puberteta****
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.
Po raziskovalčevi oceni je bila mediana časa do največjega zmanjšanja tumorja 6,7 meseca za lokalno napredovali bazalnocelični karcinom in 5,5 meseca za metastatski bazalnocelični karcinom.
Patients with Gorlin syndrome who had at least one aBCC lesion and met inclusion criteria were eligible to participate in the study.
Za sodelovanje v študiji so bili primerni bolniki z Gorlinovim sindromom, ki so imeli vsaj eno lezijo napredovalega bazalnoceličnega karcinoma in so izpolnjevali merila za vključitev.
Effects of vismodegib on concomitant medicinal products
Vpliv vismodegiba na sočasno dana zdravila
In vitro, CYP2C8 was the most sensitive CYP isoform for vismodegib inhibition.
Za zaviralni učinek vismodegiba je bila od izoform CYP in vitro najbolj občutljiva izoforma CYP2CB.
In the dedicated 26-week vismodegib rat fertility study, significantly increased absolute weights of seminal vesicles and reduced absolute weights of prostate were observed.
V usmerjeni 26-tedenski študiji z vismodegibom, v kateri so proučevali plodnost podgan, so opazili pomembno povečanje absolutne mase semenskih mešičkov in zmanjšanje absolutne mase prostate.
• The healthcare professional should report confirmed pregnancies to the MAH
• zdravstveni delavec mora o potrjenih nosečnostih obveščati imetnika dovoljenja za promet
If you do become pregnant during the treatment with Erivedge, you must stop the treatment and inform your doctor immediately.
Erivedge, morate zdravljenje prekiniti in nemudoma obvestiti svojega zdravnika.
Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
Delni odziv je doseglo 32,1 % bolnikov v skupini z metastatskim bazalnoceličnim karcinomom in 35,1 % bolnikov v skupini z lokalno napredovalim bazalnoceličnim karcinomom.
• severe: 3 x ULN < TB < 10 x ULN, AST any
• huda: 3 x ZMN < CB < 10 x ZMN, ne glede na AST
• 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
• potreba po takojšnjem poročanju bolnikov svojemu lečečemu zdravniku, če je njihova partnerka zanosila medtem, ko je on jemal zdravilo Erivedge ali kmalu po tem, ko je prenehal jemati zdravilo Erivedge
Epiphyses premature fusion****
prezgodnje zraščanje epifiz****
• your periods stop,
• izostanejo vam menstruacije,
• mild:total bilirubin (TB) ≤ upper limit of normal (ULN), aspartate aminotransferase
• blaga: celokupni bilirubin (CB) ≤ zgornja meja normale (ZMN), aspartat aminotransferaza (AST) > ZMN ali ZMN < CB ≤ 1,5 x ZMN, ne glede na AST,
and moderate (BSA-indexed CrCl 30 to 50 mL/min, n=16) renal impairment, mild and moderate impaired renal function had no clinically significant effect on the pharmacokinetics of vismodegib (see section 4.2).
do 80 ml/min, n = 58) in zmerno (očistek kreatinina glede na telesno površino 30 do 50 ml/min, n = 16) ledvično okvaro so pokazale, da blago ali zmerno okvarjeno delovanje ledvic ni imelo klinično pomembnega učinka na farmakokinetiko vismodegiba (glejte poglavje 4.2).
You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
Zdravniku morate nemudoma povedati, če se vam med zdravljenjem ali v 24 mesecih po zadnjem odmerku zdravila zgodi kaj od naslednjega:
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.
Da bi preprečil izpostavljenost ploda med nosečnostjo, mora moški bolnik med jemanjem zdravila Erivedge in še 2 meseca po zadnjem odmerku tega zdravila med spolnim odnosom s partnerko vedno uporabiti kondom (s spermicidom, če je na voljo), tudi če je imel vazektomijo.
• He will tell his healthcare provider if his female partner becomes pregnant while he is taking
• mora svojemu zdravniku povedati, če njegova partnerka zanosi, medtem ko on jemlje zdravilo
Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway.
Vismodegib je peroralen malomolekulski zaviralec signalne poti Hedgehog.
• If she stops using contraception unless she commits to not having sexual intercourse (abstinence),
• ji izostane pričakovana menstruacija, • preneha uporabljati kontracepcijo, razen, če se zaveže, da ne bo imela spolnih odnosov
The healthcare professional's reminder card should contain the following key elements
Opozorilna kartica za zdravstvene delavce mora vsebovati naslednje ključne elemente
• The need to provide patients with the patient educational material and patient reminder cards
• bolnikom posredujejo izobraževalno gradivo za bolnika in opozorilno kartico za bolnika
• moderate: 1.5 x ULN < TB < 3 x ULN, AST any
• zmerna: 1,5 x ZMN < CB < 3 x ZMN, ne glede na AST,
• Description of the patient reminder card
• Opis opozorilne kartice za bolnika
Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Vismodegib se odstranjuje počasi, s kombinacijo presnove in izločanja izvorne učinkovine.
Unused capsules should be returned at the end of treatment
• Neuporabljene kapsule morate po končanem zdravljenju vrniti.
• Printing ink: shellac glaze and iron oxide black (E172).
• tiskarsko črnilo: šelakova glazura in črni železov oksid (E 172).
Human female fertility may be compromised by treatment with Erivedge (see section 5.3).
Zdravljenje z zdravilom Erivedge lahko zmanjša plodnost pri ženskah (glejte poglavje 5.3).
Clinically significant PK interactions between vismodegib and CYP450 substrates are not expected.
Klinično pomembnih farmakokinetičnih interakcij med vismodegibom in substrati CYP450 ni pričakovati.
• Instructions to stop Erivedge upon suspicion of pregnancy
• navodila za prekinitev zdravljenja z zdravilom Erivedge ob sumu na nosečnost
Rare ( ≥ 1/10,000 to < 1/1,000)
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)
• The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
• Potrebo po obveščanju bolnikov, da morajo takoj poročati svojemu lečečemu zdravniku, če gre za sum na nosečnost pri bolnici ali če gre za sum na nosečnost pri partnerki bolnika
• The need to use condoms when having sex with a female partner during treatment and for 2 months after Erivedge treatment
• potreba po uporabi kondoma pri spolnih odnosih z žensko partnerko med zdravljenjem in 2 meseca po končanem zdravljenju z zdravilom Erivedge
• Diaphragm (with spermicide, if available).
• diafragmo (s spermicidom, če je na voljo).
Median Progression Free survival (months) (95 % CI)
Mediana preživetja brez napredovanja bolezni (meseci) (95-% interval zaupanja)
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.
Pri ženskah v rodni dobi mora zdravstveni delavec opraviti zdravniško nadzorovan test nosečnosti v 7 dneh pred začetkom zdravljenja in vsak mesec med zdravljenjem.
• Information for women of childbearing potential
• Informacije za ženske v rodni dobi
Tell your doctor in case you notice any changes in your skin.• Never give this medicine to anyone else.
Povejte svojemu zdravniku, če opazite kakršne koli spremembe na koži.
Additionally, amenorrhoea has been observed in clinical trials in WCBP (see section 4.8).
Poleg tega so v kliničnih preskušanjih pri ženskah v rodni dobi opažali amenorejo (glejte poglavje 4.8).
Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to Erivedge.
Pri pediatričnih bolnikih, izpostavljenih zdravilu Erivedge, so poročali o prezgodnjem zraščanju epifiz in prezgodnji puberteti.
Results from a clinical study demonstrated no clinically significant PK interaction between vismodegib and itraconazole (a strong P-glycoprotein inhibitor) in healthy volunteers.
Izsledki klinične študije na zdravih prostovoljcih niso pokazali klinično pomembnih farmakokinetičnih interakcij med vismodegibom in itrakonazolom (močnim zaviralcem P-glikoproteina).
Prior to study enrolment, diagnosis of BCC was confirmed by histology.
Pred vključitvijo v študijo je bila diagnoza bazalnoceličnega karcinoma potrjena histološko.
There are limited data in older people.
Podatkov za starejše bolnike je malo.
• Keep the bottle tightly closed in order to protect from moisture.
• Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.
Vismodegib se veže na beljakovino SMO in tako blokira prenos signalov po poti Hedgehog.
† Unevaluable/missing data included 1 mBCC and 4 laBCC patients.
† Neocenljivi/manjkajoči podatki so obsegali 1 bolnika z metastatskim bazalnoceličnim karcinomom in 4 bolnike z lokalno napredovalim bazalnoceličnim karcinomom.
What Erivedge is and what it is used for
Kaj je zdravilo Erivedge in za kaj ga uporabljamo 2.
Of patients who had a confirmed response (partial or complete), the median Duration of Response was 23.0 months (95% CI: 20.4, 26.7) in the laBCC cohort and 13.9 months (95% CI: 9.2, NE) in the mBCC cohort.
Od bolnikov s potrjenim odzivom (delnim ali popolnim) je bila mediana trajanja odziva v kohorti z lokalno napredovalim bazalnoceličnim karcinomom 23,0 meseca (95-% interval zaupanja: 20,4 do
• Women of childbearing potential who do not comply with the Erivedge Pregnancy Prevention
• Ženske v rodni dobi, ki ne upoštevajo Programa preprečevanja nosečnosti med uporabo zdravila
In animal species, vismodegib has been shown to cause severe irreversible changes in growing teeth (degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and haemorrhage) and closure of the epiphyseal growth plate.
ireverzibilne spremembe v rasti zob (degeneracijo/nekrozo odontoblastov, nastanek tekočinskih cist v zobni pulpi, osifikacijo koreninskega kanala in krvavitve) in zaprtje epifizne rastne plošče.
• Any male condom (with spermicide, if available),
• kondom (s spermicidom, če je na voljo),
In four open label phase 1 and 2 clinical trials patients were treated with at least one dose of Erivedge monotherapy at doses ≥ 150 mg. Doses > 150 mg did not result in higher plasma concentrations in clinical trials and patients on doses > 150 mg have been included in the analysis.
V štirih odprtih kliničnih preskušanjih faze I in II so bolnike zdravili z vsaj enim odmerkom zdravila Erivedge v monoterapiji z odmerjanjem ≥ 150 mg.
• Pregnancy test within a maximum of 7 days prior to treatment initiation, and monthly medically supervised pregnancy tests during treatment
• test nosečnosti v največ 7 dneh pred pričetkom zdravljenja, mesečni testi nosečnosti med zdravljenjem, nadzorovani s strani zdravstvenih delavcev • potrebo po takojšnji prekinitvi zdravljenja z zdravilom Erivedge ob sumu na nosečnost
For the metastatic cohort, the majority of patients had prior therapies, including surgery (91%), radiotherapy (62%) and systemic therapy (16%).
V metastatski kohorti se je večina bolnikov predhodno zdravila, vključno z operacijo (91 %), radioterapijo (62 %) in sistemskim zdravljenjem (16 %).
Additionally, safety was assessed in a post approval study that included 1215 aBCC patients evaluable for safety and treated with 150 mg.
Dodatno so varnost zdravila ocenili v študiji, ki je bila zaveza pri pridobitvi dovoljenja za promet z zdravilom, in v katero so vključili 1215 bolnikov z napredovalim bazalnoceličnim karcinomom, primernih za oceno varnosti.
laBCC** (n = 63)
lokalno napredovali bazalnocelični karcinom** (n = 63)
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Keep the bottle tightly closed in order to protect from moisture
Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago
The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Imetnik dovoljenja za promet mora ob dajanju zdravila na trg poslati neposredno obvestilo za zdravstvene delavce (DHCP), ki mora vsebovati naslednje podatke:
The patient reminder card should contain the following key elements:
Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
• The need to ensure all patients complete and sign the Erivedge Verification of Counselling Form which is to be present in the healthcare professional educational material
• Vsi bolniki morajo izpolniti in podpisati obrazec, s katerim potrdijo, da so prejeli svetovanje.
What Erivedge contains
Kaj vsebuje navodilo
Each hard capsule contains 150 mg of vismodegib.
Ena trda kapsula vsebuje 150 mg vismodegiba.
Do this during treatment and for 2 months after your final dose of this medicine.
Tako morate ravnati med zdravljenjem in še 2 meseca po zadnjem odmerku tega zdravila.
The skin reactions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
pogosto nastopijo zvišana telesna temperatura in gripi podobni simptomi (Stevens
Complete Response 0 Partial Response Stable disease Progressive disease ‡ 1
Stabilna bolezen 20 Napredovanje bolezni
In general the safety profile observed was consistent in both mBCC and laBCC patients and across studies as described below.
Na splošno so bile opažene varnostne značilnosti pri bolnikih z metastatskim bazalnoceličnim karcinomom in bolnikih z lokalno napredovalim bazalnoceličnim karcinomom v študijah skladne, kot je opisano spodaj.
For the locally advanced cohort, the majority of patients had prior therapies, including surgery (85%), radiotherapy (28%) and systemic therapy (7%).
V lokalno napredovali kohorti se je večina bolnikov predhodno zdravila, vključno z operacijo (85 %), radioterapijo (28 %) in sistemskim zdravjenjem (7 %).
Seven cases of severe cutaneous adverse reactions (SCARs) have been reported in association with vismodegib cumulatively.
V povezavi z vismodegibom so kumulativno poročali o sedmih primerih hudih kožnih neželenih učinkov (severe cutaneous adverse reactions - SCAR).
Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma.
Deluje tako, da vpliva na eno ključnih beljakovin, vpletenih v bazalnocelični karcinom.
• The need to use condoms if his sexual partner is pregnant or a women of childbearing potential (even if the man has had a vasectomy) during treatment and for 2 months after Erivedge treatment
• potreba po uporabi kondoma, če je njihova spolna partnerka noseča ali v rodni dobi med zdravljenjem in 2 meseca po končanem zdravljenju z zdravilom Erivedge (tudi če je imel moški vazektomijo)
For health care providers (HCP)
Za zdravstvene delavce
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano Drugi viri informacij
• Premature puberty (precocious puberty)
• prezgodnja puberteta,
OTHER SPECIAL WARNINGS, IF NECESSARY Risk of severe birth defects
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
• does not have a XY genotype, Turner's syndrome, or uterine agenesis,
• nima genotipa XY, Turnerjevega sindroma ali agenezije maternice, • ima po zdravljenju raka, vključno z zdravilom Erivedge, amenorejo.
• symptomatic metastatic basal cell carcinoma
Kohorta z metastatskim bazalnoceličnim karcinomom
3 patients had a best percent change in tumour size of 0; these are represented by minimal positive bars in the figure.
0; ti bolniki so na sliki prikazni z najmanjšimi pozitivnimi stolpci.
• The need to keep Erivedge capsules out of sight and reach of children
• Potrebo po shranjevanju kapsul Erivedge nedosegljivo otrokom
‡ Progression in laBCC cohort is defined as meeting any of the following criteria: (1) ≥ 20 % increase in the sum of the longest dimensions (SLD) from nadir in target lesions (either by radiography or by externally visible dimension),
‡ Napredovanje v kohorti z lokalno napredovalim bazalnoceličnim karcinomom je opredeljeno kot izpolnjevanje katerega koli od naslednjih meril: (1) ≥ 20-% povečanje vsote najdaljših premerov ciljnih lezij od njene najnižje vrednosti (radiografsko ali po na zunaj vidni dimenziji), (2) nova ulceracija ciljnih lezij, ki brez znakov celjenja traja vsaj 2 tedna, (3) nove lezije radiografsko ali na kliničnem pregledu, (4) napredovanje neciljne lezije po RECIST.
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.
Kancerogeni potencial so ugotovili le pri podganah in je bil omejen na benigne tumorje lasnih foliklov, vključno s pilomatrikomi pri ≥ 0,1
No increases in plasma vismodegib levels or toxicity were observed during these clinical trials.
Med temi kliničnimi preskušanji niso opazili porastov koncentracij vismodegiba v plazmi ali povečanja toksičnosti.
The following are recommended forms of highly effective methods:
Priporočeni visokoučinkoviti načini kontracepcije so:
Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.6).
Pri nosečnici uporabljeno zdravilo Erivedge lahko povzroči embrio-fetalno smrt ali hude prirojene napake (glejte poglavje 4.6).
• loss of appetite and weight loss,
• izguba teka in hujšanje, • utrujenost,
Criteria for a woman of childbearing potential (WCBP) A WCBP is defined in the Erivedge Pregnancy Prevention Programme as:
Merila za ženske v rodni dobi Program preprečevanja nosečnosti med uporabo zdravila Erivedge opredeljuje žensko v rodni dobi kot:
Do not pass it on to others.
• Tega zdravila ne dajajte nikomur.
• The need for adequate contraceptive measures during treatment and for 24 months after Erivedge treatment
• potreba po ustrezni kontracepcijski zaščiti med zdravljenjem in 24 mesecev po končanem zdravljenju
• A requirement to inform patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
• zahtevo za obveščanje bolnikov glede teratogenih tveganj, povezanih z zdravilom Erivedge in potrebo po izogibanju izpostavljenosti ploda zdravilu