FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1030/001
English: * The above recommendations for dose modifications are based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, developed by the National Cancer Institute (USA).
Maltese: * Ir-rakkomandazzjoni ta' hawn fuq għal tibdil fid-doża jissejsu fuq il-Kriterji ta' Terminoloġija Komuni għal Episodji Avversi (CTCAE) v4.03, żviluppati min-National Cancer Institute (USA).
English: Very common * Based on worst laboratory value post-treatment regardless of baseline, grading by CTCAE version 4.03
Maltese: Komuni ħafna * Skont l-agħar valur tal-laboratorju wara t-trattament indipendentament mil-linja bażi, gradazzjoni skont is-CTCAE verżjoni 4.03
English: Each capsule contains 200 mg sonidegib.
Maltese: Kull kapsula fiha 200 mg sonidegib.
English: Response by digital clinical photograph was evaluated by World Health Organization (WHO) adapted criteria [partial response (PR): ≥50% decrease in the sum of the product of perpendicular diameters (SPD) of a lesion; complete response (CR): disappearance of all lesions; progressive disease: ≥25% increase in the SPD of lesions].
Maltese: Ir-rispons tar-ritratt kliniku diġitali kien evalwat skont il-kriterji adattati tal-Għaqda Dinjija tas-Saħħa (WHO) [rispons parzjali (PR): tnaqqis ta' ≥50% tas-somma tal-prodott tad-dijametri perpendikulari (SPD) tal-ferita; rispons komplut (CR): tneħħija tal-feriti kollha; marda progressiva: żieda ta' ≥25% tal-SPD tal-feriti].
English: Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway.
Maltese: Sonidegib hu inibitur tal-mogħdija tas-sinjali Hh b'bijodisponibbiltà orali.
English: • medicines such as ketoconazole (not including shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections
Maltese: • mediċini bħalma huma ketoconazole (ma jinkludix xampujiet u kremi), itraconazole, posaconazole jew voriconazole użati biex jittrattaw infezzjonijiet fungali
English: Effect of age, weight and gender
Maltese: Effetti tal-età, il-piż u s-sess
English: The toxicity of sonidegib as observed in studies C2301 and X2104 in adults was in line with the already known treatment related toxicity reported in adult patients with basal cell carcinoma.
Maltese: It-tossiċità ta' sonidegib kif osservata fi studji C2301 u X2104 fl-adulti kienet skont ittossiċità diġà magħrufa relatata mal-kura rrappurtata f'pazjenti adulti b'karċinoma taċ-ċelluli bażali.
English: Odomzo 200 mg hard capsules sonidegib
Maltese: Odomzo 200 mg kapsuli Sonidegib
English: Odomzo contains the active substance sonidegib.
Maltese: X'inhu Odomzo Odomzo fih is-sustanza attiva sonidegib.
English: The sonidegib plasma concentration-QTc analysis showed that the upper bound of one-sided 95% confidence interval for QTc increase was below 5 msec at steady-state Cmax for 800 mg daily doses, which provide 2.3-fold plasma exposure compared with the recommended 200 mg dose.
Maltese: Analiżi tal-QTc tal-konċentrazzjoni ta' sonidegib fil-plażma wriet li kien hemm żieda fil-parti superjuri ta' naħa minnhom tal-95% intervall ta' kunfidenza tal-QTc ta' anqas minn 5 msek fis-Cmax fi stat wieqaf f'każ ta' dożi ta' 800 mg mogħtija kuljum, li jipprovdu espożizzjoni fil-plażma ta' 2.3 drabi mqabbel mad-doża rrakkomandata ta' 200 mg.
English: Compared to the fasted state, the Cmax and AUC of Odomzo 800 mg was increased 7.8- and 7.4-fold, respectively when the dose was given with a high-fat meal.
Maltese: Imqabbel mal-istat ta' sawm, is-Cmax u l-AUC ta' 800 mg Odomzo żdied b'7.8 u 7.4 drabi, irrispettivament meta d-doża ngħatat ma' ikla b'livell għoli ta' xaħam.
English: Of these patients, 7 (58.3%) had up to grade 1 muscle symptoms while 43 (64.1%) patients not taking HMG-CoA reductase inhibitors experienced up to grade 3 symptoms.
Maltese: Minn dawn il-pazjenti, 7 (58.3%) kellhom sintomi muskolari fi grad 1 filwaqt li 43 pazjent (64.1%) li ma ħadux inibituri tal-HMG-CoA reduttasi kellhom sintomi sa grad 3. L-ebda pazjent li ħa inibituri tal-HMG-CoA reduttasi ma kellhom elevazzjonijiet tas-CK fi grad 3/4, għall-kuntrarju ta' 6 pazjenti (9.0%) li ma ħadux inibituri tal-HMG-CoA reduttasi.
English: Results from a clinical study demonstrated a change in sonidegib exposure (32% and 38% decrease in AUC and Cmax) after co-administration of a single dose of Odomzo 200 mg with esomeprazole (a proton pump inhibitor) at 40 mg daily for 6 days in healthy subjects.
Maltese: Ir-riżultati li ħarġu minn studju kliniku wrew bidla fl-espożizzjoni għal sonidegib (tnaqqis ta' 32% u 38% fl-AUC u Cmax) wara l-għoti konġunt ta' doża waħda ta' Odomzo 200 mg flimkien ma' esomeprazole (inibitur tal-pompa protonica) b'40 mg kuljum tul 6 ijiem f'pazjenti f'saħħithom.
English: • vitamin B3, also known as niacin
Maltese: B3, magħrufa wkoll bħala nijaċin
English: In healthy subjects, co-administration of a single 800 mg dose of sonidegib with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A inhibitor, resulted in a 2.25-fold and a 1.49-fold increase in sonidegib AUC and Cmax, respectively, compared with sonidegib alone.
Maltese: F'pazjenti b'saħħithom, l-għoti ta' doża waħda ta' 800 mg sonidegib ma' ketoconazole (200 mg darbtejn kuljum għal 14-il jum), inibitur qawwi ta' CYP3A, wassal għal żieda ta' 2.25 drabi u 1.49 drabi fl-AUC u s-Cmax ta' sonidegib, rispettivament, imqabbel ma' sonidegib waħdu.
English: The following are recommended barrier methods
Maltese: Ir-rakkomandazzjonijiet li ġejjin jipprovdu metodi ta' barriera
English: • Swallow the capsule whole.
Maltese: • Ibla' l-kapsula sħiħa.
English: • medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
Maltese: • mediċini bħal ritonavir, saquinavir, jew zidovudine użati biex jittrattaw l-AIDS jew l-HIV
English: Central
Maltese: Ċentrali
English: All patients starting therapy with Odomzo must be informed of the risk of muscle-related adverse events, including the possibility of rhabdomyolysis.
Maltese: Il-pazjenti kollha mogħtija t-terapija b'Odomzo għandhom ikunu mgħarrfa bir-riskju ta' episodji avversi b'rabta mal-muskoli, inkluż il-possibbiltà ta' rabdomijoliżi.
English: Sonidegib exhibited dose-proportional increases in AUC and Cmax over the dose range from 100 mg to 400 mg, but less than dose-proportional increases above 400 mg.
Maltese: Sonidegib wera żidiet proporzjonali għad-doża fl-AUC u s-Cmax meta mogħtija doża li tvarja minn 100 mg għal 400 mg, imma anqas miż-żidiet proporzjonali għad-doża meta mogħtija aktar minn 400 mg.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate).
Maltese: Kull kapsula iebsa fiha 200 mg sonidegib (bħala fosfat).
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg was increased 2.8- and 3.5-fold, respectively, when the dose was given with a light meal.
Maltese: Imqabbel mal-istat ta' sawm, is-Cmax u l-AUC ta' Odomzo 200 mg żdiedu bi 2.8 u 3.5 drabi, rispettivament, meta d-doża ngħatat ma' ikla ħafifa.
English: • vomiting
Maltese: • Vażektomija
English: • medicines such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
Maltese: • mediċini bħalma huma telithromycin, rifampicin jew rifabutin użati biex jittrattaw infezzjonijiet batteriċi
English: Gastro-oesophageal reflux disorder
Maltese: Disturb tar-rifluss gastroesofagali
English: Myopathy [muscular fatigue and muscular weakness]
Maltese: Mijopatija [għeja muskolari u dgħufija muskolari]
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V.
Maltese: FIS-SUQ Sun Pharmaceutical Industries Europe B.V.
English: • Do not use this medicine after the expiry date which is stated on the pack and the blister after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett u l-folja wara “EXP”.
English: Warnings and precautions - Odomzo may cause muscle problems.
Maltese: Twissijiet u prekawzjonijiet - Odomzo jista' jwassal għal problemi muskolari.
English: Other medicines and Odomzo
Maltese: Mediċini oħra u Odomzo
English: Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Maltese: Tagħrif ieħor dwar il-punti ta' hawn fuq jista' jinstab fit-taqsimiet “Tqala”, “Treddigħ”, “Fertilità” u “Kontraċezzjoni għan-nisa u l-irġiel”.
English: In healthy subjects, co-administration of a single dose of 800 mg sonidegib with rifampicin (600 mg daily for 14 days), a strong CYP3A inducer, resulted in 72% and 54% decreases in sonidegib AUC and Cmax respectively, compared with when sonidegib was given alone.
Maltese: F'pazjenti b'saħħithom, l-għoti ta' doża waħda ta' 800 mg sonidegib flimkien ma' rifampin (600 mg kuljum għal 14-il jum), induttur qawwi ta' CYP3A, wassal għal tnaqqis ta' 72% u 54% fl-AUC u sCmax ta' sonidegib, rispettivament, imqabbel ma' meta sonidegib ingħata waħdu.
English: Table 4 Efficacy overview per central review and local investigator assessment by FASa
Maltese: Tabella 4 Ħarsa ġenerali lejn l-effikaċja skont konsulta ċentrali u l-evalwazzjoni talinvestigatur lokali minn FASa
English: Table 2 Adverse drug reactions observed in the phase II pivotal study Primary system organ class Preferred term
Maltese: Sistema primarja ta' klassifika tal-organi Terminu ppreferut
English: Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations and other severe midline defects.
Maltese: L-effetti teratoġeniċi kienu jinkludu malformazzjonijiet vertebrali, tar-riġel distali u diġitali, malformazzjoni kranjofaċjali gravi u difetti gravi fil-linja medjana.
English: Grade 1 [CK elevation >ULN - 2.5 x ULN]
Maltese: Grad 2 mingħajr indeboliment tal-kliewi (serum Cr ≤ ULN) [elevazzjoni tas-CK >2.5 x ULN - 5 x ULN]
English: Among these women, amenorrhoea was observed in 1 patient (20%).
Maltese: Fost dawn innisa, l-amenorrea dehret f'pazjent wieħed (20%).
English: There was no evidence of clearance change with repeated dosing based on the population pharmacokinetic analysis and estimated accumulation at steady state was 19-fold irrespective of dose.
Maltese: Ma kienx hemm evidenza ta' bidla fit-tneħħija b'dożi ripetuti skont analiżi farmakokinetika tal-popolazzjoni u l-akkumulazzjoni stmata fi stat wieqaf kien ta' 19-il darba irrispettivament middoża.
English: The secondary endpoints included duration of response, time to tumour response and progression free survival (PFS) according to mRECIST in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Maltese: L-endpoints sekondarji inklużi matul ir-rispons, iżżmien ta' rispons tat-tumur u ta' sopravivenza libera mill-progressjoni (PFS) skont mRECIST f'pazjenti b'laBCC u RECIST 1.1 f'pazjenti b'mBCC kif iddeterminat minn konsulta ċentrali.
English: • a medicine called penicillamine used to treat rheumatoid arthritis
Maltese: • mediċina msejħa penicillamine użata biex tittratta l-artrite rewmatojde
English: Severity of CK elevation
Maltese: Żidiet gravi fis-CK
English: Reproductive and developmental toxicity
Maltese: Tossiċità riproduttiva u fl-iżvilupp
English: • high level of creatinine (kidney function)
Maltese: • livell għoli ta' kreatinina (funzjoni tal-kliewi)
English: If a strong CYP3A4 inducer must be used concomitantly with sonidegib, consideration should be given to increasing the daily dose of sonidegib to 400-800 mg.
Maltese: Jekk hemm bżonn li induttur qawwi ta' CYP3A4 jintuża flimkien ma' sonidegib, wieħed għandu jikkunsidra li jżid id-doża ta' sonidegib għal 400-800 mg kuljum.
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Maltese: Il-pazjenti b'BCC avvanzata għandhom riskju iżjed li jiżviluppaw cuSCC.
English: Capsule shell
Maltese: Qafas tal-kapsula
English: Cases of cuSCC have been reported in advanced BCC patients treated with Odomzo.
Maltese: Kienu rrappurtati każijiet ta' cuSCC f'pazjenti b'BCC avvanzata ttrattati b'Odomzo.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Maltese: Qabel it-tnedija f'kull Stat Membru d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel ma' dan li ġej mal-Awtorità Nazzjonali Kompetenti:
English: The most commonly reported grade 3/4 laboratory abnormalities with an incidence of ≥5% occurring in patients treated with Odomzo 200 mg were lipase increase and blood CK increase (Table 3).
Maltese: Anormalitajiet tal-laboratorju relevanti klinikament L-aktar anormalitajiet tal-laboratorju fi grad 3/4 rrappurtati b'inċidenza ta' ≥5% li seħħew fost pazjenti ttrattati b'200 mg Odomzo kienu żieda fil-lipasi u żieda fis-CK fid-demm (Tabella 3).
English: • She must use 2 methods of recommended contraception (see the “Contraception” section below and section 4.6) while she is taking Odomzo, unless she commits to not having sexual intercourse (abstinence).
Maltese: • Għandha tuża żewġ metodi ta' kontraċezzjoni rrakkomandati (ara t-taqsima dwar “IlKontraċezzjoni” hawn taħt u s-sezzjoni 4.6) waqt li qed tieħu Odomzo, sakemm ma tintrabatx li mhux se jkollha x'taqsam sesswalment (astinenza).
English: • Diaphragm (with spermicide, if available)
Maltese: • Dijaframma (bi spermiċida, jekk disponibbli)
English: Additionally, amenorrhoea has been observed in clinical trials in women of childbearing potential (see section 4.8).
Maltese: Barra minn hekk, kienet osservata amenorrea waqt provi kliniċi f'nisa li jistgħu joħorġu tqal (ara sezzjoni 4.8).
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg increased 1.8- and 1.6-fold, respectively, when a moderate meal was taken 2 hours before the administration.
Maltese: Imqabbel mal-istat ta' sawm is-Cmax u l-AUC ta' Odomzo 200 mg żdiedu b'1.8 u 1.6 drabi, rispettivament, meta ttieħdet ikla moderata sa sagħtejn qabel l-għoti tad-doża.
English: However, results of a drug-drug interaction study in cancer patients demonstrate that the systemic exposure of bupropion (a CYP2B6 substrate) and warfarin (a CYP2C9 substrate) is not altered when co-administered with sonidegib.
Maltese: Madankollu, ir-riżultati ta' studju ta' interazzjoni bejn mediċina u oħra f'pazjenti bil-kanċer juri li l-esponiment sistemiku ta' bupropion (sottostrat ta' CYP2B6) u warfarin (sottostrat ta' CYP2C9) ma jinbidilx meta jingħataw flimkien ma' sonidegib.
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 sonidegib cannot be excluded (see also section 4.5).
Maltese: It-trattament flimkien ma' indutturi qawwija ta' CYP (eż. rifampicin, carbamazepine jew phenytoin) għandu jkun evitat, minħabba li ma jistax ikun eskluż riskju li jonqsu l-konċentrazzjonijiet fil-plażma u li tonqos l-effikaċja ta' sonidegib (ara wkoll sezzjoni 4.5).
English: The elimination half-life (t1/2) of sonidegib estimated from population pharmacokinetic modeling was approximately 28 days.
Maltese: Il-half life tal-eliminazzjoni (t1/2) ta' sonidegib stmata mill-imudellar tal-farmakokinetiċi tal-popolazzjoni kienet ta' madwar 28 jum.
English: Unchanged sonidegib in faeces represented 88.7% of the administered dose and was not detectable in urine.
Maltese: Sonidegib mhux mibdul fl-ippurgar kien jirrappreżenta 88.7% tad-doża mogħtija u ma deherx fl-awrina.
English: Adult (≥18 years of age) patients with laBCC or mBCC who were not candidates for radiotherapy, surgery or other local therapies, were randomised to receive Odomzo at either 200 mg or 800 mg daily until disease progression or unacceptable toxicity.
Maltese: Pazjenti adulti (≥18-il sena) b'laBCC jew mBCC li ma kenux kandidati għar-radjuterapija, operazzjoni jew terapiji lokali oħrajn, kienu randomizzati sabiex jingħataw Odomzo jew 200 mg jew 800 mg kuljum sakemm tibqa' tipprogressa l-marda jew ikun hemm tossiċità inaċċettabbli.
English: • does not have a XY genotype, Turner's syndrome or uterine agenesis,
Maltese: • li m'għandhiex ġenotip XY, is-sindrome ta' Turner jew aġeneżi uterina,
English: Partial response Disease stabilisation Disease progression Unknown Time to tumour response (months) Median 95% CI Duration of response No. of events* No. censored Median (months) 95% CI
Maltese: Rispons parzjali Stabilizzazzjoni tal-marda Progressjoni tal-marda Mhux magħruf Żmien għar-rispons mit-tumur (xhur) Medju 95% CI
English: Treatment interruptions of up to 3 weeks were allowed based on individual tolerability.
Maltese: It-trattament seta' jitwaqqaf sa 3 ġimgħat skont ittollerabbiltà tal-individwu.
English: Sun Pharmaceutical Industries Europe B.V. Tlf: +31 23 568 55 01
Maltese: Tlf: +31 23 568 55 01
English: Haematological parameters Haemoglobin decreased
Maltese: Parametri ematoloġiċi Tnaqqis fl-emoglobina
English: Agents that may decrease sonidegib plasma concentration
Maltese: Aġenti li jistgħu jżidu l-konċentrazzjoni ta' sonidegib fil-plażma
English: Muscle toxicity is the most clinically relevant side effect reported in patients receiving sonidegib therapy and is believed to be a class effect of inhibitors of the Hedgehog (Hh) signalling pathway.
Maltese: L-aktar effett sekondarju relevanti klinikament f'pazjenti mogħtija terapija b'sonidegib hu t-tossiċità muskolari u jidher li hu effett tal-klassi ta' inibituri tal-mogħdija ta' sinjali Hedgehog (Hh).
English: Ranbaxy Italia S.p.A. Tel: +39 02 33 49 07 93
Maltese: Sun Pharma Laboratorios S.L. Tel: +34 93 342 78 90
English: How to store Odomzo
Maltese: X'fih Odomzo
English: • medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
Maltese: • mediċini bħalma huma statini u derivattivi tal-aċidu fibriku użati biex jittrattaw kolesterol għoli u lipidi
English: Study CLDE225C2301 was a Phase II, multi-centre, open-label, single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-activated relapsed medulloblastoma.
Maltese: multiċentriku, open-label, b'parti waħda, dwar l-effikaċja u s-sigurtà ta' sonidegib orali f'pazjenti b'medulloblastoma rikaduta attivata minn Hh.
English: If clinically notable elevation of CK is detected, renal function should be assessed (see section 4.2).
Maltese: Jekk wieħed jinnota żieda klinika fis-CK, wieħed għandu jevalwa l-funzjoni tal-kliewi (ara sezzjoni 4.2).
English: Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.
Maltese: Sonidegib li jeħel ma' Smo se jinibixxi s-sinjali Hh u konsegwentament jimblokka t-traslokazzjoni tas-sinjal.
English: Substances that are BCRP substrates with narrow therapeutic range (e.g. methotrexate, mitoxantrone, irinotecan, topotecan) should be avoided.
Maltese: Sustanzi li huma sottostrati ta' BCRP b'firxa terapewtika dejqa (eż. methotrexate, mitoxantrone, irinotecan, topotecan) għandhom ikunu evitati.
English: • diarrhoea or heartburn
Maltese: • Żomm dan il-fuljett.
English: A population pharmacokinetic analysis did not find significant influence of renal function (creatinine clearance >27 ml/min) on the apparent clearance (CL/F) of sonidegib suggesting that dose adjustment is not necessary in patients with renal impairment.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ma sabitx li kien hemm influwenza qawwija fuq il-funzjoni tal-kliewi (it-tneħħija tal-kreatinina kienet ta' >27 ml/min) fejn tidħol it-tneħħija apparenti (CL/F) ta' sonidegib u dan jissuġġerixxi li mhux meħtieġ aġġustament taddoża f'pazjenti b'indeboliment renali.
English: Efficacy and safety of sonidegib have been studied in two clinical studies involving a total of 62 paediatric patients.
Maltese: L-effikaċja u s-sigurtà ta' sonidegib ġiet studjata f'żewġ studji kliniċi li kienu jinvolvu total ta' 62 pazjent pedjatriku.
English: Sun Pharma Laboratorios S.L.
Maltese: Ranbaxy Italia S.p.A.
English: • you stop using contraception
Maltese: • waqaft tuża l-kontraċezzjoni
English: Odomzo may cause severe birth defects, You must not become pregnant while taking this medicine (see “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men” in section 2 for more information).
Maltese: M'għandekx toħroġ tqila waqt li qed tieħu din ilmediċina (ara “Tqala”, “Treddigħ”, “Fertilità” u “Kontraċezzjoni għan-nisa u l-irġiel” f'sezzjoni 2 għal aktar tagħrif).
English: Patient-reported outcomes were evaluated as an exploratory endpoint using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its associated head and neck cancer specific module (H&N35).
Maltese: Ir-riżultati rrappurtati mill-pazjenti kienu evalwati bħala endpoint esploratorju billi ntuża lKwestjonarju Core 30 tal-Kwalità tal-Ħajja dwar l-Organizzazzjoni Ewropea għar-Riċerka u tTrattament tal-Kanċer (EORTC QLQ-C30) u l-modulu speċifiku assoċjat mal-kanċert tar-ras u lgħonq (H&N35).
English: It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway and eventually activates and releases glioma-associated oncogene (GLI) transcription factors which induces the transcription of Hh target genes involved in proliferation, differentiation and survival.
Maltese: Hu jeħel ma' Smoothened (Smo), molekula li tixbah lil riċettur imqabbad mal-proteina G li tirregola pożittivament il-mogħdija Hh u eventwalment tattiva u tirrilaxxa l-fatturi traskrittivi tal-onkoġenu assoċjat mal-glijoma (GLI) li jinduċi t-traskrizzjoni tal-ġeni tir Hh involuti fil-proliferazzjoni, id-differenzazzjoni u s-sopravivenza.
English: The Cmax and AUCinf of sonidegib in Japanese healthy subjects were 1.56 and 1.68-fold higher, respectively, than those seen in Western healthy subjects for a single dose of 200 mg.
Maltese: Is-Cmax u l-AUCinf ta' sonidegib f'suġġetti b'saħħithom Ġappuniżi kienu 1.56 u 1.68 drabi ogħla, rispettivament, minn dawk f'suġġetti b'saħħithom mill-Punent f'każ ta' doża waħda ta' 200 mg.
English: Amylase increased
Maltese: Żieda tal-amilasi
English: Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment (see section 4.4).
Maltese: Minħabba r-riskju ta' mewta embrijofetali jew difetti gravi fit-twelid ikkawżati minn sonidegib, nisa li qed jieħdu Odomzo ma jistgħux ikunu tqal jew joħorġu tqal waqt it-trattament u sa 20 xahar wara li jtemmu t-trattament (ara sezzjoni 4.4).
English: You must follow the Odomzo Pregnancy Prevention Programme.
Maltese: Għandek issegwi il-Programm ta' Prevenzjoni tat-Tqala ta' Odomzo.
English: Grade 3/4 increase in blood CK was reported in 8% of patients taking Odomzo 200 mg.
Maltese: Kienet irrappurtata żieda tas-CK fid-demm għal Grad 3/4 fi 8% tal-pazjenti mogħtija 200 mg Odomzo.
English: Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly.
Maltese: Sonidegib jgħaddi minn metaboliżmu primarjament b'CYP3A4, u l-għoti flimkien ta' inibituri jew indutturi qawwija ta' CYP3A4 jistgħu jżidu jew inaqqsu l-konċentrazzjonijiet ta' sonidegib b'mod qawwi.
English: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Maltese: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V.
English: The primary efficacy endpoint of the study was objective response rate according to modified Response Evaluation Criteria in Solid Tumours (mRECIST) in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Maltese: L-endpoint primarju tal-effikaċja tal-istudju kien ir-rata ta' rispons objettiv skont il-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (mRECIST) fost pazjenti b'laBCC u RECIST 1.1 f'pazjenti b'mBCC kif iddeterminat minn konsulta ċentrali.
English: The capsules must not be opened due to risk of teratogenicity (see section 5.3).
Maltese: Il-kapsuli m'għandhomx jinfetħu minħabba riskju ta' teratoġeniċità (ara sezzjoni 5.3).
English: Muscle-related events including CK elevation
Maltese: Episodji b'rabta mal-muskoli inkluż żieda tas-CK