FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Maltese: Il-punt finali primarju kien ir-rata ta' rispons oġġettiv (ORR - objective response rate) kif evalwat minn faċilità ta' analiżi indipendenti (IRF - independent review facility) kif miġbur fil-qosor fitTabella 2.
English: 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.
Maltese: Ma jistax jiġi eskluż li vismodegib jista' jwassal għal esponiment akbar għal prodotti mediċinali trasportati minn din il-proteina, bħal rosuvastatin, topotecan, u sulfasalazin.
English: Vismodegib is present in semen.
Maltese: Vismodegib huwa preżenti fis-semen.
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.
Maltese: Skont il-valutazzjoni mill-investigatur, iż-żmien medjan sa tnaqqis massimu tat-tumur seħħ fi żmien 6.7 u 5.5 xhur għal pazjenti b'laBCC u b'mBCC rispettivament.
English: Vismodegib inhibits UGT2B7 in vitro and it may not be excluded that inhibition can take place in vivo in the intestine.
Maltese: Vismodegib jinibixxi UGT2B7 in vitro u ma jistax jiġi eskluż li l-inibizzjoni tista' sseħħ in vivo fl imsaren.
English: For the metastatic cohort, the majority of patients had prior therapies, including surgery (91%), radiotherapy (62%) and systemic therapy (16%).
Maltese: Għall-koorti metastatiku, il-maġġoranza tal-pazjenti kellhom terapiji preċedenti, inklużi kirurġija (91%), radjuterapija (62%) u terapija sistemika (16%).
English: The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Erivedge fit-tfal u l-adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati.
English: WCBP must be able to comply with effective contraceptive measures.
Maltese: WCBP trid tkun tista' tikkonforma ma' miżuri ta' kontraċezzjoni effettiva.
English: • muscle, tendon, ligament, bone pain,
Maltese: • uġigħ fil-muskoli, fit-tendons, fil-ligamenti, fl-għadam,
English: • locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
Maltese: • karċinoma taċ-ċelluli bażi avanzata lokalment li mhux adattata għall-kirurġija jew għal radjuterapija (ara sezzjoni 5.1).
English: Metastatic BCC was defined as BCC that had spread beyond the skin to other parts of the body, including the lymph nodes, lung, bones and/or internal organs.
Maltese: BCC metastatika kienet iddefinita bħala BCC li nfirxet 'il bogħod mill-ġilda għal partijiet oħra tal-ġisem, inklużi l-glandoli tal-limfa, il-pulmun, l-għadam u/jew l-organi interni.
English: • you stop using contraception,
Maltese: • tieqaf tuża kontraċezzjoni,
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).
Maltese: Syndrome/TEN - Toxic Epidermal Necrolysis), Reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug reaction with eosinophilia and systemic symptoms) u pustulożi eżantematuża ġeneralizzata akuta (AGEP - acute generalized exanthemaetous pustulosis), li jistgħu jkunu ta' periklu għall-ħajja, ġew irrappurtati waqt l-użu ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
Maltese: Rispons komplut inkiseb f'4.8% talpazjenti fil-koorti ta' mBCC u fi 33.4% fil-koorti ta' laBCC.
English: Metastatic BCC was defined as histologically confirmed distant metastasis.
Maltese: BCC metastatika kienet iddefinita bħala metastasi fil-bogħod ikkonfermata istoloġikament.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: In the dedicated 26-week vismodegib rat fertility study, significantly increased absolute weights of seminal vesicles and reduced absolute weights of prostate were observed.
Maltese: Fl-istudju dedikat ta' 26 ġimgħa dwar l-effett ta' vismodegib fuq il-fertilità fil-far, kienu osservati żidiet sinifikanti fil-piżijiet assoluti ta' seminal vesicles u tnaqqis fil-piżijiet assoluti tal-prostata.
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,
Maltese: • Għandu jkollha test tat-tqala negattiv kull xahar waqt it-trattament, anki jekk issir amenorrejika,
English: The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Maltese: Ir-rotot ewlenin ta' eliminazzjoni ta' vismodegib jinvolvu metaboliżmu epatiku u sekrezzjoni biljari/intestinali.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX43.
Maltese: Sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, Kodiċi ATC:
English: Clinically significant PK interactions between vismodegib and CYP450 inhibitors are not expected.
Maltese: Mhumiex mistennija interazzjonijiet PK klinikament sinifikanti bejn vismodegib u inibituri ta' CYP450.
English: 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:
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment epatiku ħafif, moderat jew sever iddefinit abbażi ta' kriterji ta' indeboliment epatiku tan-National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG):
English: Additionally, amenorrhoea has been observed in clinical trials in WCBP (see section 4.8).
Maltese: Barra dan, fi provi kliniċi f'WCBP kien osservat telf tal-mestrwazzjoni (ara sezzjoni 4.8).
English: • itchiness.
Maltese: • stitikezza,
English: • Widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Maltese: • Raxx mifrux, deni, u tkabbir tal-glandoli tal-limfa (sindrome DRESS jew sindrome ta' sensittività eċċessiva għall-mediċina).
English: Very common ( ≥ 1/10)
Maltese: Komuni ħafna (≥ 1/10)
English: Patients with a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problema ereditarja rari ta' intolleranza għal galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: 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.
Maltese: (1) tnaqqis ta' ≥ 30 % fid-daqs tal-leżjoni [total tal-itwal dijametru (SLD - sum of the longest diameter)], mil-linja bażi ta' leżjonijiet immirati minn radjografija; (2) tnaqqis ta' ≥ 30 % f'SLD mil-linja bażi fid-dimensjoni viżibbli esterna ta' leżjonijiet immirati; (3) Fejqan komplut tal-ulċerazzjoni fil-leżjonijiet immirati kollha.
English: • if you are also taking St John's wort (Hypericum perforatum) - a herbal medicine used for depression (see “Other medicines and Erivedge”).
Maltese: • jekk qed tieħu wkoll St John's wort (Hypericum perforatum) - mediċina mill-ħxejjex użata għad-depressjoni (ara “Mediċini oħra u Erivedge”).
English: • Intrauterine device (IUD).
Maltese: • Vażektomija, • Apparat ġewwa l-utru (IUD - intrauterine device).
English: Based on population pharmacokinetic analysis of combined data from 121 males and 104 females, gender did not appear to affect the pharmacokinetics of vismodegib.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' data kkombinata minn 121 raġel u 104 nisa,
English: Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink.
Maltese: Qafas opak ta' lewn roża mmarkat b'“150 mg” u għatu griż opak immarkat b'“VISMO” b'linka sewda.
English: 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.
Maltese: Riżultati minn studju kliniku wrew tnaqqis ta' 33% fil konċentrazzjonijiet ta' vismodegib mhux marbut wara 7 ijiem ta' trattament fl-istess waqt b'20 mg rabeprazole (inibitur tal-pompa tal-protoni) mogħti sagħtejn qabel kull għoti ta' vismodegib.
English: Very limited data is available in patients with severe renal impairment.
Maltese: Hemm disponibbli data limitata ħafna f'pazjenti b'indeboliment renali sever.
English: PD = progressive disease, SD = stable disease, R = response, * = complete resolution of ulceration(s).
Maltese: Nota: Id-daqs tat-tumur huwa bbażat fuq it-total tal-itwal dimensjonijiet tal-leżjonijiet immirati. PD = marda progressiva, SD = marda stabbli, R = rispons, * = fejqan komplut tal-ulċerazzjoni(jiet).
English: Fertility impairment in human males is not expected (see Section 5.3).
Maltese: Mhux mistenni indeboliment fil-fertilità fl-irġiel (ara Sezzjoni 5.3).
English: Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to Erivedge.
Maltese: F'pazjenti pedjatriċi esposti għal Erivedge kienu rrappurtati fużjoni prematura tal-epifisi u pubertà prekoċi.
English: Criteria for a woman of childbearing potential (WCBP) A WCBP is defined in the Erivedge Pregnancy Prevention Programme as:
Maltese: Kriterji għal mara li tista' toħroġ tqila (WCBP - woman of child-bearing potential) WCBP hija ddefinita fil-Programm għall-Prevenzjoni tat-Tqala ta' Erivedge bħala:
English: 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).
Maltese: John's wort), l-esponiment għal vismodegib jista' jonqos (ara sezzjonijiet 4.3 u 4.4).
English: In clinical trials with aBCC, approximately 40 % of patients were of geriatric age (≥ 65 years).
Maltese: Fi provi kliniċi dwar aBCC, madwar 40% tal-pazjenti kellhom età ġerjatrika (≥ 65 sena).
English: The majority of patients were male (57%); 8% had mBCC whereas 92% had laBCC.
Maltese: 8% kellhom mBCC waqt li 92% kellhom laBCC.
English: 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.
Maltese: Fost il-pazjenti fil-popolazzjoni li setgħet tiġi evalwata għall-effikaċja, bil-marda li setgħet titkejjel u li kienet ikkonfermata istoloġikament, 68.5% u 36.9% irrispondew għat-trattament fil-koorti ta' laBCC u mBCC, rispettivament, permezz ta' RECIST v1.1.
English: Among patients who achieved tumour reduction, the median time to maximum tumour reduction occurred in 5.6 and 5.5 months for laBCC and mBCC patients respectively, based on the IRF assessment.
Maltese: Fost il-pazjenti li laħqu tnaqqis tat-tumur, iż-żmien medjan sa tnaqqis massimu tat-tumur seħħ fi żmien 5.6 u 5.5 xhur għall-pazjenti b'laBCC u b'mBCC rispettivament, ibbażat fuq evalwazzjoni minn IRF.
English: In addition, the ratio of organ weight to terminal body weight was significantly increased for epididymis, cauda epididymis, testes and seminal vesicles.
Maltese: Barra dan, il-proporzjon tal-piż tal-organi għall-piż terminali tal-ġisem żdied b'mod sinifikanti għallepididymis, cauda epididymis, testikoli u seminal vesicles.
English: • Liver injury Serious skin reactions:
Maltese: • Reazzjonijiet severi fil-ġilda:
English: The following are recommended forms of barrier methods:
Maltese: Metodu ta' kontraċezzjoni rakkomandata:
English: Vismodegib concentrations are strongly correlated with AAG levels, showing parallel fluctuations of AAG and total vismodegib over time and consistently low unbound vismodegib levels.
Maltese: Il-konċentrazzjonijiet ta' vismodegib huma korrelatati sew mal-livelli ta' AAG, u juru varjazzjonijiet paralleli ta' AAG u vismodegib totali matul iż-żmien u livelli konsistentement baxxi ta'
English: • a condom (with spermicide, if available)
Maltese: • kondom (bi spermiċida, jekk disponibbli)
English: Fertility preservation strategies should be discussed with WCBP prior to starting treatment with Erivedge.
Maltese: Strateġiji ta' preservazzjoni talfertilità għandhom jiġu diskussi ma' WCBP qabel ma jinbeda trattament b'Erivedge.
English: The bottle cap material is Polypropylene.
Maltese: L-għatu tal-flixkun huwa magħmul minn Polypropylene.
English: You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Maltese: M'għandekx toħroġ tqila waqt li qed tieħu din il-mediċina (ara sezzjoni 2 “Tiħux Erivedge” u “Tqala, treddigħ u fertilità”).
English: Flank pain
Maltese: U LUŻU
English: • rifampicin - used for bacterial infections,
Maltese: • rifampicin - użat għall-infezzjonijiet ikkawżati minn batterji,
English: **Includes preferred terms: liver function test abnormal, blood bilirubin increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, liver hepatic enzyme increased.
Maltese: MedDRA = Dizzjunarju Mediku għall-Attivitajiet Regolatorji. **Tinkludi termini ppreferuti: test tal-funzjoni tal-fwied mhux normali, żieda ta' bilirubina fid-demm, żieda f'gamma-glutamyl transferase, żieda f'aspartate aminotransferase, żieda f'alkaline phosphatase, żieda fl-enzimi
English: For men taking Erivedge
Maltese: DATA TA' SKADENZA
English: • She must use 2 methods of recommended contraception (see the ‘Contraception' section below and section 4.6) while she is taking Erivedge, unless she commits to not having sexual intercourse (abstinence),
Maltese: • Għandha tuża 2 metodi ta' kontraċezzjoni rakkomandata (ara s-sezzjoni ‘Kontraċezzjoni' hawn taħt u s-sezzjoni 4.6) waqt li tkun qed tieħu Erivedge, sakemm ma tikkommettix ruħha li ma jkollhiex x'taqsam sesswalment (astinenza),
English: • Do not store above 30 °C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 30 °C.
English: • becomes amenorrhoeic following cancer therapy, including treatment with Erivedge.
Maltese: • il-mestrwazzjoni tagħha tieqaf wara terapija għall-kanċer, inkluż trattament b'Erivedge.
English: Dysgeusia Ageusia
Maltese: TWISSIJIET SPEĊJALI
English: The median duration of treatment was 12.9 months (range 0.7 to 47.8 months).
Maltese: 12.9 xhur (firxa minn 0.7 sa 47.
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: Erivedge fih tip ta' zokkor imsejjaħ lactose.
English: In clinical trials, treatment with Erivedge was continued until disease progression or until unacceptable toxicity.
Maltese: Fi provi kliniċi, trattament b'Erivedge tkompla sal-progressjoni tal-marda jew sa tossiċità inaċċettabbli.
English: Suomi/Finland Roche Oy
Maltese: Suomi/Finland
English: 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).
Maltese: Ibbażat fuq analiżi PK tal-popolazzjoni f'pazjenti b'indeboliment renali ħafif (CrCl skont l-indiċi talBSA 50 sa 80 mL/min, n=58) u moderat (CrCl skont l-indiċi tal-BSA 30 sa 50 mL/min, n=16), indeboliment ħafif u moderat tal-funzjoni renali ma kellu l-ebda effett klinikament sinifikanti fuq il farmakokinetika ta' vismodegib (ara sezzjoni 4.2).
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.
Maltese: Ma kienx hemm evidenza ta' effett tossiku fuq il-ġeni f'analiżi in vitro (mutaġenesi riversiva tal batterji [Ames] u analiżi ta' anormalitajiet fil-kromożomi tal-limfoċiti umani) jew fl-analiżi in vivo tal mikronukleu tal-mudullun tal-firien.
English: • Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
Maltese: • Il-ħtieġa li jiġi żgurat li l-pazjenti kollha jimlew u jiffirmaw il-Formola ta' Verifika tal-Għoti ta' Pariri dwar Erivedge li għandha tkun preżenti fil-materjal edukattiv għall-professjonisti tal kura tas-saħħa • Formoli għar-rappurtar ta' avvenimenti avversi
English: Myalgia
Maltese: Ġelatina
English: Responders
Maltese: Astenja
English: 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.
Maltese: Malformazzjonijiet, inkluż anomaliji tal-kranju u tal-wiċċ, perineum miftuħ, u swaba' nieqsa u/jew imwaħħlin flimkien, kienu osservati fil-feti ta' ommijiet b'dożi li jikkorrispondu għal 20% tal esponiment tipiku fi stat fiss fil-pazjenti, u b'dożi ogħla kienet osservata inċidenza ta' mewt tal embriju ta' 100%.
English: Additional findings at clinically relevant exposures included faecal changes; skeletal muscle twitching or tremors; alopecia; swelling, follicular hyperkeratosis, and inflammation in paw pads; and increased LDL and HDL cholesterol.
Maltese: Sejbiet addizzjonali f'esponimenti klinikament rilevanti jinkludu bidliet fl-ippurgar; kontrazzjonijiet jew rogħda fil-muskoli skeletali; alopeċja, nefħa,
English: Patients with severe renal impairment should be carefully monitored for adverse reactions.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: 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.
Maltese: F'erba' provi kliniċi open label ta' fażi 1 u 2, il-pazjenti kienu ttrattati b'mill-inqas doża waħda ta' monoterapija ta' Erivedge f'dożi ta' ≥ 150 mg.
English: Other side effects are presented in order of severity and frequency:
Maltese: Effetti sekondarji oħra huma ppreżentati skont is-severità u l-frekwenza:
English: Women of childbearing potential (WCBP)
Maltese: Nisa li jistgħu joħorġu tqal (WCBP - women of child-bearing potential)
English: For the locally advanced cohort, the majority of patients had prior therapies, including surgery (85%), radiotherapy (28%) and systemic therapy (7%).
Maltese: Għall-koorti b'avanz lokali, il-maġġoranza tal-pazjenti kellhom terapiji preċedenti, inklużi kirurġija (85%), radjuterapija (28%) u terapija sistemika (7%).
English: • Diaphragm (with spermicide, if available).
Maltese: • dijaframma (bi spermiċida, jekk disponibbli).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Hedgehog pathway signalling through the Smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of Glioma-Associated Oncogene (GLI) transcription factors and induction of
Maltese: Is-sinjalar tar-rotta Hedgehog permezz tal-Proteina transmembranika llixxjata (SMO - Smoothened transmembrane protein) iwassal għall-attivazzjoni u għal-lokalizzazzjoni nukleari ta' fatturi ta' transkrizzjoni tal-Onkoġene Assoċjata ma' Glijoma (GLI - Glioma-Associated Oncogene) u għallinduzzjoni ta' ġeni fil-mira ta' Hedgehog.
English: Erivedge is indicated for the treatment of adult patients with:
Maltese: Erivedge huwa indikat għat-trattament ta' pazjenti adulti b':
English: Amongst these women, amenorrhoea was observed in 3 patients (30 %).
Maltese: Fost dawn in-nisa, telf tal-mestrwazzjoni kien osservat fi 3 pazjenti (30%).
English: • Emergency contact phone numbers
Maltese: • Numri tat-telefon għal kuntatt ta' emerġenza
English: • muscle spasm,
Maltese: • spażmu fil-muskoli,
English: • a diaphragm (with spermicide, if available).
Maltese: • Dijaframma (bi spermiċida, jekk disponibbli).
English: Alopecia Pruritus Rash
Maltese: FULJETT TA' TAGĦRIF
English: In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Maltese: reżistenza tal-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: 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).
Maltese: n=6), u sever (kriterji NCI-ODWG, n=3), il-profil farmakokinetiku ta' vismodegib kien komparabbli ma' dak ta' individwi b'funzjoni epatika normali (n=9) (ara sezzjoni 4.2).
English: Complete Response 0 Partial Response Stable disease Progressive disease ‡ 1
Maltese: Marda stabbli Marda progressiva ‡ 1
English: Of a total number of 138 patients in 4 clinical trials of Erivedge in advanced basal cell carcinoma, approximately 40 % of patients were ≥ 65 years old and no overall differences in safety and efficacy were observed between these patients and younger patients.
Maltese: 40% tal-pazjenti kellhom età ta' ≥ 65 sena u ma kienet osservata l-ebda differenza globali fis-sigurtà u l-effikaċja bejn dawn il-pazjenti u pazjenti iżgħar.
English: *** Observed in patients during a post-approval study with 1215 safety evaluable patients.
Maltese: *** Osservati f'pazjenti waqt studju ta' wara l-approvazzjoni b'1215-il pazjent li setgħu jiġu evalwati għassigurtà.
English: Very rare ( < 1/10,000)
Maltese: Rari ħafna (< 1/10,000)
English: 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.
Maltese: Riżultati minn studju kliniku wrew żieda ta' 57% fil-konċentrazzjonijiet ta' vismodegib mhux marbut fil-jum 7 wara trattament fl-istess waqt b'400 mg fluconazole (inibitur moderat ta'
English: However, the interaction study was of only 7 days duration and it cannot be excluded that vismodegib upon longer treatment is an inducer of enzymes which metabolise contraceptive steroids.
Maltese: Madankollu, l-istudju ta' interazzjoni dam biss 7 ijiem u ma jistax jiġi eskluż li vismodegib bi trattament aktar fit-tul huwa induttur ta' enzimi li jimmetabolizzaw sterojdi kontraċettivi.