FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is sonidegib (as phosphate).
Maltese: • Is-sustanza attiva hi sonidegib (bħala fosfat).
English: Each hard capsule contains 38.6 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 38.6 mg lactose monohydrate.
English: Crospovidone (Type A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate
Maltese: Crospovidone (Tip A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate
English: Iron oxide red (E172) Titanium dioxide (E171)
Maltese: Iron oxide aħmar (E172) Titanium dioxide (E171)
English: [Grade 3 (CK elevation >5 x ULN - 10 x ULN)] [Grade 4 (CK elevation >10 x ULN)]
Maltese: [Grad 3 (elevazzjoni tas-CK >5 x ULN - 10 x ULN)] [Grad 4 (elevazzjoni tas-CK >10 x ULN)]
English: MRI tumour response was evaluated by RECIST 1.1.
Maltese: Irrispons tat-tumur MRI kien evalwat minn RECIST 1.1.
English: Table 3 Laboratory abnormalities*
Maltese: Tabella 3 Anormalitajiet tal-laboratorju*
English: They are imprinted with “SONIDEGIB 200MG” and “NVR”.
Maltese: Għandhom fuqhom stampat “SONIDEGIB 200MG” u “NVR”.
English: INFORMATION IN BRAILLE Odomzo 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Odomzo 200 mg
English: The majority of patients (laBCC 74%, mBCC 92%) had undergone prior therapies including surgery (laBCC 73%, mBCC 85%), radiotherapy (laBCC 18%, mBCC 54%) and antineoplastic therapies (laBCC 23%, mBCC 23%).
Maltese: Il-biċċa l-kbira tal-pazjenti (laBCC 74%, mBCC 92%) kien kellhom qabel terapiji inkluż operazzjoni (laBCC 73%, mBCC 85%), radjuterapija (laBCC 18%, mBCC 54%) u terapiji antineoplastiċi (laBCC 23%, mBCC 23%).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 August 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 14 Awwissu 2015
English: • Capsule contents: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
Maltese: • Kontenuti tal-kapsula: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
English: AUCinf of sonidegib was 40%, 22% and 8% lower, respectively.
Maltese: L-AUCinf ta' sonidegib kien 40%, 22% u 8% aktar baxx, rispettivament.
English: 30 x 1 hard capsule
Maltese: 30 x 1 kapsula iebsa
English: • your periods stop
Maltese: • nuqqas ta' periods menstrwali
English: Iron oxide black (E172) Propylene glycol (E1520) Shellac
Maltese: Iron oxide iswed (E172) Propylene glycol (E1520) Shellac
English: CI: confidence interval
Maltese: CI: intervall ta' kunfidenza
English: Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Maltese: Tqala u treddigħ (ara sezzjonijiet 4.4 u 4.6).
English: Do not take Odomzo:
Maltese: Tiħux Odomzo:
English: Sonidegib did not inhibit apical efflux transporters, P-gp or MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Maltese: Sonidegib ma inibixxiex it-trasportaturi tal-effluss apikali, P-gp jew MRP2, it-trasportaturi ta' adozzjoni epatika OATP1B1 jew OATP1B3, it-trasportaturi ta' adozzjoni tal-anjoni organiku renali OAT1 u OAT3, jew it-trasportaturi ta' adozzjoni tal-kazzjoni organika OCT1 jew OCT2 f'konċentrazzjonijiet relevanti b'mod kliniku.
English: Aspartate amino transaminase (AST) increased
Maltese: Żieda tal-aspartat amino transaminasi (AST)
English: Biochemistry parameters Serum creatinine increased
Maltese: Parametri bijokimiċi Żieda tal-kreatinina fis-serum
English: Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
Maltese: Inibituri qawwija ta' CYP3A jinkludu, imma mhumiex limitati biss għal, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole u nefazodone.
English: • Emergency contact phone numbers
Maltese: • Numri tat-telefon fejn jistgħu jċemplu f'każ ta' emerġenza
English: 10 x 1 hard capsule
Maltese: 10 x 1 kapsula iebsa
English: Odomzo capsules contain lactose monohydrate.
Maltese: Il-kapsuli ta' Odomoz fihom il-lactose monohydrate.
English: • Adverse event reporting
Maltese: • Rappurtar ta' episodji avversi
English: Cr: creatinine; ULN: upper limit of normal
Maltese: ULN: l-ogħla limitu tan-normalità
English: Effect of ethnicity
Maltese: Effett tal-etniċità
English: Of the 230 patients, 16 had a diagnosis of Gorlin Syndrome (15 laBCC and 1 mBCC).
Maltese: Mill230 pazjent, 16 kellhom dijanjosi tas-Sindrome ta' Gorlin (15 laBCC u 1 mBCC).
English: Sonidegib is primarily metabolised by CYP3A4.
Maltese: Sonidegib hu mmetabolizzat primarjament b'CYP3A4.
English: • Intrauterine device (IUD)
Maltese: • Tagħmir intrauterinu (IUD)
English: Alanine amino transaminase (ALT) increased
Maltese: Żieda tal-analina amino transaminasi (ALT)
English: • Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
Maltese: • Qafas tal-kapsula: gelatin, iron oxide aħmar (E172), titanium dioxide (E171).
English: Cutaneous squamous cell carcinoma (cuSCC)
Maltese: Karċinoma taċ-ċellola skwamuża fil-ġilda (cuSCC)
English: Odomzo is provided in perforated unit-dose blisters containing 10 x 1 capsule.
Maltese: Odomzo hu disponibbli f'folji pperforati b'dożi singoli li fihom 10 x 1 kapsula.
English: The evaluation of safety in the paediatric population is based on data from 16 adult and 60 paediatric patients from Study CLDE225X2104 and 16 adult and 2 paediatric patients from Study CLDE225C2301.
Maltese: L-evalwazzjoni tas-sigurtà fil-popolazzjoni pedjatrika hi bbażata fuq dejta minn 16-il pazjent adult u 60 pazjent pedjatriku minn Studju CLDE225X2104, u 16-il pazjent adult u 2 pazjenti pedjatriċi minn Studju CLDE225C2301.
English: Patients were treated with Odomzo 200 mg daily (n=79) or with Odomzo 800 mg daily (n=150).
Maltese: Il-pazjenti kienu ttrattati b'200 mg Odomzo kuljum (n=79) jew bi 800 mg Odomzo kuljum (n=150).
English: moderate (Child-Pugh class B; n=8) or severe (Child-Pugh class C; n=9) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Maltese: Il-farmakokinetiċi ta' sonidegib kienu eżaminati f'suġġetti b'indeboliment epatiku minn ħafif (ChildPugh klassi A; n=8), moderat (Child-Pugh klassi B; n=8) jew gravi (Child-Pugh klassi C; n=9) u fi 8 suġġetti b'saħħithom b'funzjoni tal-fwied normali.
English: Sonidegib is also a breast cancer resistance protein (BCRP) inhibitor (IC50 ~1.5µM).
Maltese: Sonidegib hu wkoll inibitur tal-proteina reżistenti għall-kanċer tas-sider (BCRP) (IC50 ~1.5µM).
English: • Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.
Maltese: • Linka stampata: iron oxide iswed (E172), propylene glycol (E1520), shellac.
English: Patients should be closely monitored for muscle-related symptoms if Odomzo is used in combination with certain medicinal products that may increase the potential risk of developing muscle toxicity (e.g. CYP3A4 inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin and HMG-CoA reductase inhibitors) (see section 4.5).
Maltese: Il-pazjenti għandhom ikunu segwiti mill-qrib għal sintomi b'rabta mal-muskoli jekk Odomzo qed jintuża flimkien ma' ċerti prodotti mediċinali oħrajn li jistgħu jżidu r-riskju potenzjali li tiżivluppa tossiċità muskolari (eż. inibituri tas-CYP3A4, chloroquine, hydroxychloroquine, derivattivi tal-aċidu fibriku, penicillamine, zidovudine, niacin u inibituri tar-reduttasi ta' HMG-CoA) (ara sezzjoni 4.5).
English: • an intra-uterine device (“the coil” or IUD)
Maltese: • tagħmir intrauterin (“il-kojl” jew IUD)
English: Sonidegib was highly bound to human plasma proteins (human serum albumin and alpha-1 acid glycoprotein) in vitro (>97%), and binding was not concentration-dependent from 1 ng/ml to 2500 ng/ml.
Maltese: Sonidegib weħel b'saħħa mal-proteini umani fil-plażma (albumina tas-serum uman u aċidu alpha-1 glikoproteina) in vitro (>97%), u t-twaħħil ma kienx jiddependi mill-konċentrazzjoni minn 1 ng/ml għal 2500 ng/ml.
English: Amenorrhoea
Maltese: Amenorrea
English: Cmax of sonidegib after a single oral 800 mg dose was 20%, 21% and 60% lower in mild, moderate and severe hepatic impairment, respectively, compared to normal hepatic function.
Maltese: Is-Cmax ta' sonidegib wara doża waħda ta' 800 mg mogħtija oralment kien 20%, 21% u 60% aktar baxx f'pazjenti b'indeboliment epatiku ħafif, moderat u gravi, risepttivament, imqabbel ma' pazjenti b'funzjoni epatika normali.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: [CK elevation >2.5 x ULN - 5 x ULN]
Maltese: [żidiet fis-CK >ULN - 2.5 x ULN]
English: Grade 2, 3 or 4 with renal impairment (serum Cr > ULN)
Maltese: Grad 2, 3 jew 4 b'indeboliment tal-kliewi (serum Cr ≤ ULN)
English: Progressive Disease
Maltese: Marda Progressiva
English: AUClast was 35% lower in mild hepatic impairment, 14% higher in moderate hepatic impairment and 23% lower in severe hepatic impairment.
Maltese: L-AUClast kien 35% aktar baxx f'pazjenti b'indeboliment epatiku ħafif, 14% ogħla f'pazjenti b'indeboliment epatiku moderat u 23% aktar baxx f'pazjenti b'indeboliment epatiku gravi.
English: The median age of all patients receiving Odomzo 200 mg was 67 years (59.5% were >65 years of age), 60.8% were male and 89.9% Caucasian.
Maltese: L-età medja tal-pazjenti kollha mogħtija 200 mg Odomzo kienet ta' 67 sena (59.5% kellhom >65 sena), 60.8% kienu rġiel u 89.9% Kawkażjatiċi.
English: All the metabolites were deemed 4 to 90 times less potent than sonidegib.
Maltese: Il-metaboliti kollha kienu mistennija li jkunu 4 sa 90 darba inqas qawwija minn sonidegib.
English: Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St John's Wort (Hypericum perforatum).
Maltese: L-użu flimkien ta' indutturi qawwija ta' CYP3A għandu jkun evitat; dan jinkludi, imma mhuwiex limitat għal, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin u St John's Wort (Hypericum perforatum).
English: Nervous system disorders Dysgeusia
Maltese: Disturbi fis-sistema nervuża Disgweżja
English: The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC.
Maltese: II evalwa s-sigurtà ta' Odomzo fost total ta' 229 pazjent adult b'BCC avvanzata lokalment jew metastatika.
English: A phase II, randomised double-blind study of two dose levels (200 mg or 800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma (laBCC) (n=194) or metastatic basal cell carcinoma (mBCC) (n=36).
Maltese: II, randomizzat double-blind dwar żewġ livelli ta' doża (200 mg jew 800 mg darba kuljum) ta' Odomzo seħħ fost 230 pazjent li kellhom jew karċinoma taċ-ċellola bażali avvanzata lokalment (laBCC) (n=194) jew karċinoma taċ-ċellola bażali metastatika (mBCC) (n=36).
English: • has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Maltese: • li ma kellhiex isterektomija jew ooforektomija bilaterjali, jew li m'għandhiex insuffiċjenza ovarika prematura permanenti kkonfermata medikament,
English: Progression-free survival probability (%), (95% CI)
Maltese: Probabbiltà ta' sopravivenza ħielsa minn episodji (%), (95% CI)
English: The average steady state Ctrough for 200 mg was 830 ng/ml (range 200 to 2400 ng/ml) in cancer patients.
Maltese: Il-medja tal-istat wieqaf Ctrough għal 200 mg kien ta' 830 ng/ml (medda ta' 200 sa 2400 ng/ml) f'pazjenti bil-kanċer.
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/ml as per local availability.
Maltese: It-testijiet tat-tqal għandhom sensittività minima ta' 25 mIU/ml skont id-disponibbiltà lokali.
English: The most common adverse drug reactions occurring in ≥10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus.
Maltese: L-aktar reazzjonijiet komuni avversi mill-mediċina f'≥10% tal-pazjenti ttrattati b'200 mg Odomzo kienu spażmi muskolari, allopeċja, diżgweżja, għeja, dardir, uġigħ muskoloskeletriku, dijarrea, tnaqqis fil-piż, tnaqqis fl-aptit, mijalġja, uġigħ fl-addome, uġigħ ta' ras, uġigħ, rimettar u ħakk.
English: Event-free probability (%), (95% CI) 6 months 9 months 12 months Progression-free survival No. of events* No. censored Median (months) 95% CI
Maltese: Probabbiltà ta' ħelsien minn episodji (%), (95% CI) 6 xhur 9 xhur 12-il xahar Sopravivenza ħielsa minn progressjoni Nru ta' episodji* Nru ċċensurat Medja (xhur) 95% CI
English: In the phase II pivotal study, 2 (14.3%) out of 14 women of either child-bearing potential or of child-bearing age sterilised by tubal ligation developed amenorrhoea while on treatment with Odomzo 200 mg or 800 mg once daily.
Maltese: II, 2 (14.3%) minn 14-il mara li jew setgħu joħorġu tqal jew li kellhom età li setgħu joħorġu tqal sterilizzati b'ligazzjoni tubali żviluppaw amenorrea waqt it-trattament b'200 mg jew 800 mg Odomzo darba kuljum.
English: Very common * Of the 79 patients receiving Odomzo 200 mg, 5 were women of childbearing age.
Maltese: Komuni ħafna * Mid-79 pazjent mogħtija 200 mg Odomzo, 5 kienu nisa f'età li jistgħu joħorġu tqal.
English: Musculoskeletal and connective tissue disorders Muscle spasms
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Spażmi fil-muskoli
English: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Maltese: Sun Pharmaceutical Industries Europe B.V.
English: Objective response rate, n (%) 95% CI Best overall response, n (%) Complete response
Maltese: Rata ta' rispons objettiv, n (%) 95% CI
English: Population pharmacokinetic analyses showed that there are no clinically relevant effects of age (range tested from 20-93 years, mean 61 years), body weight (range tested 42-181 kg, mean 77 kg), gender, or creatinine clearance (range tested 27.3-290 ml/min, mean 92.9 ml/min) on the systemic exposure of sonidegib.
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni wrew li l-età (firxa evalwata minn 20-93 sena, medja 61 sena), il-piż (firxa evalwata 42-181 kg, medja 77 kg), is-sess, jew it-tneħħija tal-kreatinina (firxa evalwata 27.
English: In the phase II pivotal trial, 12 (15.2%) patients treated with Odomzo 200 mg took concomitant HMG-CoA reductase inhibitors (9 took pravastatin, 3 took non-pravastatin HMG-CoA reductase inhibitors including rosuvastatin and simvastatin).
Maltese: 2%) mill-pazjenti mogħtija 200 mg Odomzo ħadu fl-istess ħin inibituri tal-HMG-CoA reduttasi (9 ħadu pravastatin, 3 ħadu inibituri tal-HMG-CoA reduttasi mhux pravastatin inkluż rosuvastatin u simvastatin).
English: The CTCAE is a standardised classification of side effects used in assessing medicinal products for cancer therapy.
Maltese: Is-CTCAE hi sistema ta' klassifikazzjoni standardizzata ta' effetti sekondarji użata biex tevalwa prodotti mediċinali għat-terapija tal-kanċer.
English: • constipation
Maltese: • konstipazzjoni
English: Odomzo is contraindicated in woman of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see section 4.3).
Maltese: Odomzo hu kontraindikat għal mara li tista' toħroġ tqila li ma timxix mal-Programm ta' Prevenzjoni ta' Tqala ta' Odomzo (ara sezzjoni 4.3).
English: Based on a population pharmacokinetic analysis of 351 patients who received oral doses of Odomzo in the dose range of 100 mg to 3000 mg, the apparent steady-state volume of distribution (Vss/F) was 9170 litres.
Maltese: Skont analiżi farmakokinetika tal-popolazzjoni ta' 351 pazjent mogħtija dożi orali ta' Odomzo fil-firxa tad-dożi ta' bejn 100 mg u 3000 mg, il-volum ta' distribuzzjoni apparenti fi stat wieqaf (Vss/F) kien ta' 9170 litru.
English: In the phase II pivotal study muscle spasms were the most common “muscle-related” adverse events, and were reported in fewer patients in the Odomzo 200 mg group (54%) than in the Odomzo 800 mg group (69%).
Maltese: II l-iktar episodji avversi komuni “relatati mal-muskoli” kienu spażmi muskolari, u kienu rrappurtati f'anqas pazjenti fost dawk mogħtija 200 mg Odomzo (54%) milli fost il-grupp mogħti 800 mg Odomzo (69%).
English: • surgical sterilisation.
Maltese: • sterlizzazzjoni b'operazzjoni.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes fuq il-konvenzjoni li ġejja (CIOMS III): komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • She must be able to comply with effective contraceptive measures.
Maltese: • Trid tkun kapaċi timxi mal-miżuri għal kontraċezzjoni effettiva.
English: The sonidegib-related toxicity reported in paediatric patients was similar to the results reported in adults, with the exceptions of a reduced incidence of muscle toxicity (e.g. CK elevations observed in 16.7% of paediatric patients compared with 50% of adults in study X2104) and the observation of post-natal development effect particularly with prolonged exposure (reported as cases of epiphyseal plate of phalanx disorder, knee subchondral condensation of area of growth plate, physeal distal femur disorder, chondropathy, and chipped tooth).
Maltese: It-tossiċità relatata ma' sonidegib irrappurtata f'pazjenti pedjatriċi kienet simili għarriżultati rrappurtati fl-adulti, bl-eċċezzjonijiet tal-inċidenza mnaqqsa ta' tossiċità tal-muskoli (eż. żidiet fis-CK osservati f'16.7% tal-pazjenti pedjatriċi meta mqabbla ma' 50% tal-adulti fi studju X2104), u l-osservazzjoni tal-effett tal-iżvilupp wara t-twelid, b'mod partikulari b'esponiment fit-tul (irrappurtat bħala każijiet ta' disturb tal-epiphyseal plate of phalanx, kondensazzjoni subkondrali tal-irkoppa taż-żona tal-plate tat-tkabbir, disturb tal-physeal distal femur, kondropatija, u snien imxelfin).
English: Based on in vitro data, sonidegib is not a substrate of P-gp, BCRP or multi-resistance protein 2 (MRP2).
Maltese: Skont dejta in vitro, sonidegib mhuwiex sottostrat ta' P-gp, BCRR jew tal-proteina multireżistenti 2 (MRP2).
English: 10 x 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 10 x 1 kapsula iebsa f'folji tal-PCTFE/PVC/aluminju pperforati li fihom dożi singoli.
English: • high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase
Maltese: • livelli għolja tal-enzimi li ġejjin: fosfokinasi tal-kreatinina (funzjoni tal-muskoli), lipasi u/jew amilasi (funzjoni tal-frixa), analina aminotransferasi (ALT) u/jew aspartat aminotransferasi
English: Adverse drug reactions for the recommended dose from the phase II pivotal clinical study (Table 2) are listed by Medical Dictionary for Regulatory Activities (MedDRA) version 18 system organ class.
Maltese: Ir-reazzjonijiet avversi tal-mediċina għad-doża rrakkomandata skont studju pivotali kliniku f'fażi II (Tabella 2) jinsabu mniżżla skont is-sistema tal-klassifika tal-organi li tidher fid-Dizzjunarju Mediku tal-Attivitajiet Regolatorji (MedDRA) verżjoni 18.
English: The median duration of exposure to sonidegib during Study C2301 was 2.8 months (range 0.4 to 33.2 months) for adult patients and 3.5 months (range 1.3 to 5.7 months) for paediatric patients.
Maltese: It-tul medjan tal-esponiment ta' sonidegib matul Studju C2301 kien ta' 2.8 xhur (medda minn 0.4 sa 33.2 xhur) għall-pazjenti adulti, u 3.5 xhur (medda minn 1.3 sa 5.7 jum) għall-pazjenti pedjatriċi.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX48
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħrajn, Kodiċi ATC:
English: The median duration of treatment was 11.0 months for patients treated with Odomzo at the recommended dose of 200 mg (range 1.3 to 41.3 months).
Maltese: It-tul medju tat-trattament kien ta' 11.0 xhur għall-pazjenti ttrattati bid-doża rrakkomandata ta' 200 mg Odomzo (medda ta' 1.3 sa 41.3 xhur).
English: • medicines such as carbamazepine, phenytoin or phenobarbital used to treat acute seizures
Maltese: • mediċini bħalma huma carbamazepine, phenytoin jew phenobarbital użati biex jittrattaw attakki epilettiċi
English: Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see sections 4.4 and 4.6).
Maltese: Nisa li jistgħu joħorġu tqal li ma jimxux mal-Programm ta' Prevenzjoni ta' Tqala ta' Odomzo (ara sezzjonijiet 4.4 u 4.6).
English: • a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression.
Maltese: • mediċina erbali msejħa St John's wort (magħrufa wkoll bħala Hypericum perforatum) użata biex tittratta d-dipressjoni.
English: Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC).
Maltese: Sinjali anormali Hh kienu marbuta mal-patoġenesi ta' bosta tipi ta' kanċer inkluż tal-karċinoma taċċellola bażilari (BCC).
English: • Vasectomy
Maltese: • vitamina
English: The median duration of exposure to sonidegib during Study X2104 was 97 days (range 34 to 511 days) for adult patients and 55 days (range 2 to 289 days) for paediatric patients.
Maltese: It-tul medjan tal-esponiment ta' sonidegib matul Studju X2104 kien ta' 97 jum (medda minn 34 sa 511 jum) għall-pazjenti adulti, u 55 jum (medda minn 2 sa 289 jum) għall-pazjenti pedjatriċi.
English: Unchanged sonidegib represented 36% of circulating radioactivity and the major circulating metabolite (45% of parent exposure) identified in plasma is the hydrolysis product of sonidegib and is pharmacologically inactive.
Maltese: Sonidegib mhux mibdul irrappreżenta 36% tarradjuattività ċirkolatorja u l-metabolit ċirkolatorju ewlieni (45% tal-espożizzjoni ġenitur) identifikat fil-plażma hu l-prodott idroliżi ta' sonidegib u hu inattiv farmakoloġikament.
English: Of the 230 patients randomised, 79 patients were assigned to Odomzo 200 mg. Of these 79 patients, 66 (83.5%) were laBCC patients (37 [46.8%] with aggressive histology and 29 [36.7%] with non-aggressive histology) and 13 (16.5%) were mBCC patients.
Maltese: Minn dawn id79 pazjent, 66 (83.5%) kienu pazjenti b'laBCC (37 [46.8%] b'istoloġija aggressiva u 29 [36.7%] b'istoloġija mhux aggressiva) u 13 (16.
English: It is available in pack sizes of 10 and 30 capsules.
Maltese: Kull pakkett fih 10 jew 30 kapsula iebsa.
English: For patients with laBCC, the Independent Review Committee (IRC) Composite Overall Response was integrated from centrally evaluated MRI scans, digital clinical photographs and histopathology according to mRECIST.
Maltese: Għal pazjenti b'laBCC, ir-Rispons Ġenerali Kompost tal-Kumitat ta' Konsulta Indipendenti (IRC) kien integrat skont skens tal-MRI, ritratti kliniċi diġitali u istopatoloġija skont mRECIST evalwati b'mod ċentralizzat.
English: • becomes amenorrhoeic following cancer therapy, including treatment with Odomzo.
Maltese: • li spiċċat b'amenorrea wara terapija għall-kontra l-kanċer, inkluż trattament b'Odomzo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001 10 hard capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1030/001 10 kapsuli iebsa EU/1/15/1030/002 30 kapsula iebsa
English: Sonidegib and its metabolites are eliminated primarily by the hepatic route with 93.4% of the administered dose recovered in the faeces and 1.95% recovered in urine.
Maltese: Sonidegib u l-metaboliti tiegħu huma eliminati primarjament mir-rotta epatika bi 93.4% tad-doża mogħtija rkuprata fl-ippurgar u 1.95% rkuprata fl-awrina.