FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Pazjenti b'laBCC kellhom leżjonijiet fil-ġilda li ma kinux xierqa għall-kirurġija (ma setgħux jiġu operati, immultiplikaw b'mod rikorrenti fejn fejqan permezz ta' tneħħija kirurġika kien meqjus bħala mhux probabbli jew li għalihom kirurġija kienet twassal għal deformità jew morbidità sostanzjali) u li għaliha radjuterapija ma kinitx ta' suċċess jew kienet kontraindikata jew ma kinitx xierqa.
English: The PRAC therefore recommends that the Product Information should be updated accordingly.
Maltese: Jekk jogħġbok irreferi għal dawn id-dokumenti għal aktar informazzjoni.
English: Erivedge can pass into semen.
Maltese: Donazzjoni ta' semen
English: After a single oral dose, vismodegib has a terminal half-life of ca. 12 days.
Maltese: Wara doża orali waħda, vismodegib ikollu half-life terminali ta' madwar 12-il ġurnata.
English: Effects of concomitant medicinal products on vismodegib
Maltese: Effetti ta' prodotti mediċinali li jittieħdu fl-istess waqt fuq vismodegib
English: Clinically significant PK interactions between vismodegib and P-gp inhibitors are not expected.
Maltese: Interazzjonijiet PK klinikament sinifikanti bejn vismodegib u inibituri ta' P-gp mhumiex mistennija.
English: The volume of distribution for vismodegib is low, ranging from 16.4 to 26.6 L. In vitro binding of vismodegib to human plasma proteins is high (97 %) at clinically relevant concentrations.
Maltese: Irbit in vitro ta' vismodegib mal-proteini fil-plażma umana huwa għoli (97%) f'konċentrazzjonijiet klinikament rilevanti.
English: What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Maltese: X'inhu Erivedge Erivedge huwa mediċina kontra l-kanċer u fih is-sustanza attiva vismodegib.
English: Itraconazole (a strong CYP3A4 inhibitor) 200 mg daily did not influence vismodegib AUC0-24h after 7 days co-treament in healthy volunteers.
Maltese: CYP2C9) kuljum, iżda din l-interazzjoni mhix mistennija li tkun klinikament sinifikanti. 200 mg kuljum ta' itraconazole (inibitur qawwi ta' CYP3A4) ma influwenzawx l-AUC0-24 siegħa ta'
English: • sulfasalazine - used for certain inflammatory disorders, and especially,
Maltese: • sulfasalazine - użat għal ċerti disturbi infjammatorji, u b'mod speċjali,
English: The use of Erivedge in children and adolescents under the age of 18 years is not recommended.
Maltese: L-użu ta' Erivedge fi tfal u adolexxenti b'età inqas minn 18-il sena mhux rakkomandat.
English: Cases of cuSCC have been reported in advanced BCC patients treated with Erivedge.
Maltese: Mhux magħruf jekk SCC hijiex relatata mat-trattament b'Erivedge.
English: • St. John's wort (Hypericum perforatum) - a herbal medicine used for depression, since you must not use it at the same time as Erivedge.
Maltese: John's wort (Hypericum perforatum) - mediċina mill-ħxejjex użata għad-depressjoni, peress li m'għandekx tużaha fl-istess waqt ma' Erivedge.
English: Results from a clinical study demonstrated no clinically significant PK interaction between vismodegib and itraconazole (a strong P-glycoprotein inhibitor) in healthy volunteers.
Maltese: Riżultati minn studju kliniku ma wrew l-ebda interazzjoni PK klinikament sinifikanti bejn vismodegib u itraconazole (inibitur qawwi ta' glikoproteina P) f'voluntiera f'saħħithom.
English: Upon continuous daily dosing, there is a 3 fold accumulation of vismodegib total plasma concentrations.
Maltese: Wara dożaġġ kontinwu ta' kuljum, ikun hemm akkumulazzjoni ta' 3 darbiet il konċentrazzjonijiet totali ta' vismodegib fil-plażma.
English: Hedgehog target genes.
Maltese: Erivedge huwa għall-użu orali.
English: 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.
Maltese: Fl-istudju dedikat ta' 26 ġimgħa dwar l-effett ta' vismodegib fuq il-fertilità fil-far, l-effetti marbuta ma' vismodegib fuq l-organi riproduttivi femminili kienu osservati b'100 mg/kg/jum immedjatament wara l-waqfien tat-trattament, u kienu jinkludu tnaqqis fl-impjantazzjoni, żieda fil-perċentwali ta' telf qabel l-impjantazzjoni, u numru mnaqqas ta' ommijiet b'embrijuni vijabbli.
English: Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Maltese: Taħt kondizzjonijiet klinikament rilevanti (stat fiss), il-PK ta' vismodegib mhix affettwata mill-ikel.
English: In the same study there were no histopathological findings in male reproductive organs and no effects on male fertility endpoints, including percent motile sperm, observed at 100 mg/kg/day at the end of dosing or recovery phase (corresponding to 1.3-fold of the steady-state AUC0-24h at the recommended human dose).
Maltese: Fl-istess studju ma kien hemm l-ebda sejba istopatoloġika fl-organi riproduttivi maskili u l-ebda effett fuq il-punti finali tal-fertilità maskili, inkluż il-perċentwali ta' sperma li tiċċaqlaq, osservati b'100 mg/kg/jum fl-aħħar tad-dożaġġ jew fil-fażi ta' rkupru (li tikkorrispondi għal 1.3 darbiet l-AUC0-24siegħa fi stat fiss bid-doża rakkomandata filbniedem).
English: • if you are breast-feeding or plan to breast-feed during the course of treatment or during the 24 months after your final dose of this medicine.
Maltese: • M'għandekx tagħti demm waqt it-trattament u għal 24 xahar wara l-aħħar doża tiegħek ta' din il-mediċina.
English: ******Cases of SCAR (including SJS/TEN, DRESS and AGEP) have been reported in patients during post-marketing use.
Maltese: ****** Waqt l-użu ta' wara t-tqegħid fis-suq, fil-pazjenti ġew irrappurtati każijiet ta' SCAR (inklużi SJS/TEN, DRESS u AGEP).
English: † Unevaluable/missing data included 1 mBCC and 4 laBCC patients.
Maltese: Data li ma tistax tiġi stmata/nieqsa kienet tinkludi pazjent wieħed b'mBCC u 4 pazjenti b'laBCC.
English: Therefore, mild and moderate renal impairment is unlikely to have a clinically significant effect on the pharmacokinetics of vismodegib.
Maltese: Għalhekk, indeboliment renali ħafif u moderat mhux probabbli li jkollu effett klinikament sinifikanti fuq il-farmakokinetika ta' vismodegib.
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.
Maltese: L-esponiment fil-firien nisa b'100 mg/kg jikkorrispondi għal 1.2 darbiet l-AUC0-24siegħa fi stat fiss bid-doża rakkomandata fil-bniedem.
English: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Maltese: Tel: +36 - 23 446 800
English: Key data are summarised in Table 2:
Maltese: Data importanti hija miġbura fil-qosor fit-Tabella 2:
English: The skin reactions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Maltese: Syndrome)/Nekroliżi Epidermali Tossika (TEN - Toxic Epidermal Necrolysis),
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.
Maltese: Ittestjar għat-tqala F'WCBP, għandu jsir test tat-tqala taħt superviżjoni medika, imwettaq minn fornitur tal-kura tas saħħa, fis-7 ijiem qabel ma jinbeda t-trattament u kull xahar waqt it-trattament.
English: Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
Maltese: Persistenza ta' nuqqas ta' mestrwazzjonijiet waqt it-trattament b'Erivedge għandha titqies li tindika tqala sakemm isiru valutazzjoni u konferma medika.
English: Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
Maltese: Qoxra tal-kapsula Iron oxide iswed (E172)
English: More information on the issues above is found in the sections “Pregnancy, breast-feeding and fertility” and “Contraception - for men and women”.
Maltese: Aktar informazzjoni dwar il-kwistjonijiet imsemmija hawn fuq tinsab fis-sezzjonijiet “Tqala, treddigħ u fertilità” u “Kontraċezzjoni - għall-irġiel u n-nisa”.
English: 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.
Maltese: Wara għoti orali ta' doża radjutikkettata, vismodegib jiġi assorbit u eliminat bil-mod permezz ta' kombinazzjoni ta' metaboliżmu u ta' tneħħija tas-sustanza mediċinali oriġinali, li l-maġġoranza tagħha tiġi rkuprata fl-ippurgar (82% tad-doża mogħtija), b'4.4% tad-doża mogħtija rkuprata fl-awrina.
English: Asthenia
Maltese: Erivedge
English: Counselling For a WCBP Erivedge is contraindicated in a WCBP who does not comply with the Erivedge Pregnancy Prevention Programme.
Maltese: HCPs għandhom jedukaw lill-pazjenti sabiex dawn jifhmu u jirrikonoxxu l-kondizzjonijiet kollha talProgramm għall-Prevenzjoni tat-Tqala ta' Erivedge.
English: In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
Maltese: Barra dan, fl-istudju ta' 26 ġimgħa dwar l-effett tossiku ġenerali ta' vismodegib, kien osservat tnaqqis fin-numru ta' corpora lutea b'100 mg/kg/jum; l-effett ma reġax lura għan-normal sal-aħħar ta' perjodu ta' rkupru ta' 8 ġimgħat.
English: In vitro binding to AAG is saturable at clinically relevant concentrations.
Maltese: Irbit in vitro ma' AAG huwa saturabbli f'konċentrazzjonijiet klinikament rilevanti.
English: WCBP, whose periods are irregular or stopped, must follow all the advice on effective contraception.
Maltese: WCBP, li l-mestrwazzjonijiet tagħha jkunu irregolari jew waqfu, għandha ssegwi l-parir kollu dwar kontraċezzjoni effettiva.
English: • topotecan - used for certain types of cancer,
Maltese: • topotecan - użat għal ċerti tipi ta' kanċer,
English: Due to the risk of embryo-foetal death or severe birth defects caused by vismodegib, women taking Erivedge must not be pregnant or become pregnant during treatment and for 24 months after the final dose (see sections 4.3 and 4.4).
Maltese: Minħabba r-riskju ta' mewt tal-embriju-fetu jew difetti severi tat-twelid ikkawżati minn vismodegib, nisa li jieħdu Erivedge m'għandhomx ikunu tqal jew joħorġu tqal waqt it-trattament u għal 24 xahar wara l-aħħar doża (ara sezzjonijiet 4.3 u 4.4).
English: It has not been determined whether cuSCC is related to Erivedge treatment.
Maltese: Ma ġiex stabbilit jekk cuSCC hijiex relatata ma' trattament b'Erivedge.
English: For men
Maltese: Tista'
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.
Maltese: valutazzjoni viżiva tat-tumur estern u tal-ulċerazzjoni, immaġini tat-tumur (fejn xieraq), u bijopsija tattumur.
English: 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.
Maltese: Dożi ta' > 150 mg ma rriżultawx f'konċentrazzjonijiet ogħla fil-plażma fil-provi kliniċi u pazjenti fuq dożi ta' > 150 mg kienu inklużi fl-analiżi.
English: • Instructions to stop Erivedge upon suspicion of pregnancy
Maltese: • Istruzzjonijiet biex jitwaqqaf Erivedge hekk kif ikun hemm suspett ta' tqala
English: Roche d.o.o Tel: +385 1 4722 333
Maltese: Tel: +385 1 4722 333
English: • Information for patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Maltese: • Informazzjoni għall-pazjenti dwar ir-riskji ta' teratoġeniċità assoċjati ma' Erivedge u l-ħtieġa li jiġi evitat esponiment tal-fetu
English: Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Maltese: Vismodegib jiġi eliminat bil-mod permezz ta' kombinazzjoni ta' metaboliżmu u ta' tneħħija tassustanza mediċinali oriġinali.
English: The following are recommended forms of highly effective methods:
Maltese: Li ġejjin huma forom rakkomandati ta' metodi effettivi ħafna:
English: Muscle spasms Arthralgia Pain in extremity
Maltese: Spażmi fil-muskoli Uġigħ fil-ġogi Uġigħ fl-estremitajiet
English: Microcrystalline cellulose
Maltese: Kontenut tal-kapsula Microcrystalline cellulose Lactose monohydrate Sodium lauril sulfate
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).
Maltese: Inibituri tar-rotta Hedgehog, (ara sezzjoni 5.1) bħal vismodegib, intwerew li huma embrijotossiċi u/jew teratoġeniċi f'ħafna speċijiet ta' annimali u jistgħu jikkawżaw malformazzjonijiet severi, inklużi anomaliji fil-kranju u l-wiċċ, difetti fil-linja tan-nofs u difetti fir-riġlejn u d-dirgħajn (ara sezzjoni 5.3). Erivedge m'għandux jintuża waqt it-tqala.
English: • Patient Brochure
Maltese: • Distribuzzjoni tal-prodott
English: Each hard capsule contains 150 mg of vismodegib.
Maltese: Kull kapsula fiha 150 mg ta' vismodegib.
English: • has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate.
Maltese: • ikun infirex lejn żoni fil-viċin (imsejjaħ karċinoma “avanzata lokalment” taċ-ċelluli bażi) u t tabib tiegħek jiddeċiedi li t-trattament b'kirurġija jew radjazzjoni mhuwiex xieraq.
English: Effects of vismodegib on concomitant medicinal products
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: How to take Erivedge
Maltese: Tiħux Erivedge:
English: Seven cases of severe cutaneous adverse reactions (SCARs) have been reported in association with vismodegib cumulatively.
Maltese: Seba' każijiet ta' reazzjonijiet avversi severi fil-ġilda (SCARs - severe cutaneous adverse reactions) kienu rrappurtati b'rabta ma' vismodegib b'mod kumulattiv.
English: Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.
Maltese: Vismodegib jintrabat ma' u jinibixxi l-proteina SMO u b'hekk jimblokka t-transduzzjoni tas-sinjal Hedgehog.
English: Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of vismodegib cannot be excluded (see also section 4.5).
Maltese: għandu jiġi evitat, peress li ma jistax jiġi eskluż riskju ta' konċentrazzjonijiet imnaqqsa fil-plażma u effikaċja mnaqqsa ta' vismodegib (ara wkoll sezzjoni 4.5).
English: Pregnancy
Maltese: Eċċipjenti
English: Frequencies are defined as:
Maltese: Il-frekwenzi huma ddefiniti bħala:
English: Contraception
Maltese: Teratoġeniċità
English: 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.
Maltese: Tnaqqis fl-ematokrit jew fl-għadd tal-plejtlits kien osservat f'xi klieb f'esponimenti klinikament rilevanti; madankollu, ma kienx hemm evidenza ta' effett primarju fuq il-mudullun f'annimali affettwati.
English: NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules
Maltese: Erivedge 150 mg kapsuli ibsin
English: (2) New ulceration of target lesions persisting without evidence of healing for at least 2 weeks, (3) New lesions by radiography or physical examination, (4) Progression of non-target lesions by RECIST.
Maltese: (osservati permezz ta' radjografija jew mid-dimensjoni viżibbli esternament), (2) Ulċerazzjoni ġdida tal-leżjonijiet immirati li ppersistiet mingħajr evidenza ta' fejqan għal mill-inqas ġimagħtejn, (3) Leżjonijiet ġodda osservati permezz ta' radjografija jew eżami fiżiku, (4) Progressjoni ta' leżjonijiet mhux fil-mira skont RECIST.
English: Nausea Diarrhoea Constipation Vomiting Dyspepsia
Maltese: Disġewżja Aġewżja
English: 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.
Maltese: LaBCC kienet iddefinita bħala leżjonijiet fil-ġilda li ma kinux adattati għall-kirurġija (ma setgħux jiġu operati, jew li għalihom kirurġija kienet twassal għal deformità sostanzjali) u li għalihom radjuterapija ma rnexxietx jew kienet kontraindikata.
English: Patients were treated with oral daily dosing of Erivedge at 150 mg.
Maltese: Il-pazjenti kienu ttrattati b'dożaġġ orali ta' kuljum ta' Erivedge 150 mg.
English: Prescriptions of Erivedge should be limited to 28 days of treatment and continuation of treatment requires a new prescription.
Maltese: Riċetti ta' Erivedge għandhom ikunu limitati għal 28 jum ta' trattament u l-kontinwazzjoni tat-trattament teħtieġ riċetta ġdida.
English: 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).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Erivedge f'kull sett tal-popolazzjoni pedjatrika b'karċinoma taċ-ċelluli bażi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
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).
Maltese: Inibituri tar-rotta Hedgehog (ara sezzjoni 5.1) bħal vismodegib, intwerew li huma embrijotossiċi u/jew teratoġeniċi f'ħafna speċijiet ta' annimali u jistgħu jikkawżaw malformazzjonijiet severi, inkluż anomaliji fil-kranju u l-wiċċ, difetti fil-linja tan-nofs u difetti fir-riġlejn u d-dirgħajn (ara sezzjoni 5.3). F'każ ta' tqala f'mara ttrattata b'Erivedge, it-trattament għandu jitwaqqaf minnufih.
English: Induction could lead to decreases in systemic exposure of the contraceptive steroids and thereby reduced contraceptive efficacy.
Maltese: Induzzjoni tista' twassal għal tnaqqis fl-esponiment sistemiku għall-isterojdi kontraċettivi u b'hekk tnaqqas l-effikaċja kontraċettiva.
English: After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Maltese: Wara dożaġġ kontinwu ta' darba kuljum, il-farmakokinetika ta' vismodegib tidher li mhix lineari minħabba assorbiment saturabbli u rbit mal-proteini saturabbli.
English: Printing ink Shellac glaze Iron oxide black (E172)
Maltese: Iron oxide iswed (E172)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vismodegib, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal vismodegib, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
Maltese: Il-half-life evidenti ta' vismodegib fi stat fiss hija stmata li hija ta' 4 ijiem b'dożaġġ kontinwu ta'
English: Increased number of degenerating germ cells and hypospermia in sexually immature dogs observed at ≥ 50 mg/kg/day in the 4-week general toxicity study was of undetermined relationship to vismodegib.
Maltese: Iż-żieda finnumru ta' ċelluli ġerminali li qed jiddeġeneraw u ipospermija fi klieb sesswalment immaturi osservati b'≥ 50 mg/kg/jum fl-istudju ġenerali ta'4 ġimgħat dwar l-effett tossiku ma kellhiex relazzjoni determinata għal vismodegib.
English: Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Maltese: Interruzzjonijiet fit-trattament sa 4 ġimgħat kienu permessi abbażi tat-tollerabilità individwali.
English: • loss of monthly periods in women of childbearing age,
Maltese: • telf tal-mestrwazzjonijiet ta' kull xahar f'nisa ta' età li jistgħu joħorġu tqal,
English: Hrvatska
Maltese: Alopeċja
English: For the laBCC cohort (n = 63), 94 % of patients had prior therapies including surgery (89 %), radiotherapy (27 %), and systemic/topical therapies (11 %).
Maltese: (89%), radjuterapija (27%), u terapiji sistemiċi/topiċi (11%).
English: • She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
Maltese: • Għandu jkollha test tat-tqala negattiv, imwettaq minn professjonist tal-kura tas-saħħa fi żmien 7 ijiem qabel tibda trattament b'Erivedge,
English: • Any male condom (with spermicide, if available),
Maltese: • Kull kondom għall-irġiel (bi spermiċida, jekk disponibbli),
English: • joint pain,
Maltese: • uġigħ fil-ġogi,
English: This is because it is not known if it is safe or effective in this age group.
Maltese: Dan għax mhux magħruf jekk huwiex sigur jew effettiv f'persuni f'dan il-grupp ta' età.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: D-79639 Grenzach-Wyhlen
English: • Not to breastfeed during treatment and for 24 months after Erivedge treatment
Maltese: • Ifakkru lill-pazjenti biex ma jagħtux demm matul it-trattament u għal 24 xahar wara l-aħħar doża
English: • Do not crush, open or chew the capsule, to avoid unintended exposure to the capsule contents.
Maltese: • Tfarrakx, tiftaħx u tomgħodx il-kapsula, biex jiġi evitat esponiment mhux intenzjonat għall kontenut tal-kapsula.
English: Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni tissuġġerixxi li l-età ma kellhiex impatt klinikament sinifikanti fuq il-konċentrazzjoni fi stat fiss ta' vismodegib.
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.
Maltese: Madankollu, riżultati ta' studju ta' interazzjoni bejn mediċina u oħra mwettaq f'pazjenti bil-kanċer urew li l-esponiment sistemiku għal rosiglitazone (sottostrat ta' CYP2C8) ma jinbidilx meta jingħata flimkien ma' vismodegib.
English: • loss of water from the body (dehydration),
Maltese: • telf ta' ilma mill-ġisem (deidratazzjoni),
English: Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma.
Maltese: Erivedge huwa mediċina kontra l-kanċer li jaħdem billi jikkontrolla waħda mill-proteini prinċipali involuti f'karċinoma taċċellula bażi.
English: The findings of premature fusion of the epiphyses indicate a potential risk for short stature and tooth deformities to infants and children (see section 5.3).
Maltese: Is-sejbiet ta' fużjoni prematura tal-epifisi jindikaw riskju potenzjali ta' statura qasira u deformità fis-snien għattrabi u t-tfal (ara sezzjoni 5.3).
English: • Information for women of childbearing potential
Maltese: • Informazzjoni dwar ir-rimi ta' medikazzjoni mhux mixtieqa
English: • Methodology to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Maltese: • Il-metodoloġija biex tinġabar informazzjoni dwar l-użu ta' Erivedge u l-konformità malprogramm ta' farmakoviġilanza tat-tqala u l-effettività tiegħu
English: • He must always use the recommended contraception (see the ‘Contraception' section below and section 4.6),
Maltese: • Għandu dejjem juża l-kontraċezzjoni rakkomandata (ara s-sezzjoni ‘Kontraċezzjoni' hawn taħt u s-sezzjoni 4.6),
English: • Bones stop growing (epiphyses premature fusion)
Maltese: • L-għadam jieqaf jikber (fużjoni prematura tal-epifisi)