FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro data indicate that regorafenib is a competitive inhibitor of the cytochromes CYP2C8 (Ki value of 0.6 micromolar), CYP2C9 (Ki value of 4.7 micromolar), CYP2B6 (Ki value of 5.2 micromolar) at concentrations which are achieved in vivo at steady state (peak plasma concentration of 8.1 micromolar).
Maltese: 0.6 mikromolari), CYP2C9 (valur Ki ta' 4.7 mikromolari), CYP2B6 (valur Ki ta' 5.2 mikromolari) f'konċentrazzjonijiet li huma miksuba in vivo fi stat fiss ( konċentrazzjoni massima fil-plażma ta'
English: Metabolites M-2 and M-5 are weak substrates of P-gp.
Maltese: M-2 u M-5 huma sottostrati għall-glikoproteina P u BCRP.
English: Two major and six minor metabolites of regorafenib have been identified in plasma.
Maltese: Fil-plażma kienu identifikati żewġ metaboliti prinċipali ta' regorafenib u sitta minuri.
English: There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.
Maltese: Ma kien hemm l-ebda indikazzjoni ta' potenzjal ġenotossiku ta' regorafenib ttestjati f'analiżi standard in vitro u in vivo fil-ġrieden.
English: >3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
Maltese: (Grad 2 jew ogħla) flimkien ma' bilirubin >2 darbiet ULN
English: P-value (one-sided)
Maltese: Valur p (naħa waħda)
English: Management of HFSR may include the use of keratolytic creams (e.g. urea-, salicylic acid-, or alpha hydroxyl acid-based creams applied sparingly only on affected areas) and moisturizing creams (applied liberally) for symptomatic relief.
Maltese: Immaniġġar ta' HFSR jista' jinkludi l-użu ta' krema keratolitika (eż. krema bbażata fuq urea, salicylic acid jew alpha hydroxyl acid applikata bil-qies biss fuq żoni affettwati) u krema idratanti (applikata b'mod ġeneruż skont il-bżonn) għal serħan sintomatiku.
English: Tablet core
Maltese: Kriżi ipertensiva
English: Of the 760 randomised patients, the median age was 61 years, 61% were male, 78% were Caucasian, and all patients had baseline ECOG Performance Status (PS of 0 or 1.
Maltese: Mis-760 pazjent li kienu randomised, l-età medjana kienet ta' 61 sena, 61% kienu rġiel, 78% kienu
English: Available clinical data and physiology-based pharmacokinetic modelling indicate similar steady-state exposure of regorafenib and its metabolites M-2 and M-5 in patients with mild or moderate renal impairment, compared to patients with normal renal function.
Maltese: Dejta klinika disponibbli u mmudellar farmakokinetiku bbażat fuq il-fiżjoloġija jindikaw esponiment simili għal regorafenib u l-metaboliti tiegħu M-2 u M-5 fi stat fiss f'pazjenti b'indeboliment renali ħafif jew moderat meta mqabbel ma' pazjenti b'funzjoni renali normali.
English: Severe liver injury*#
Maltese: Korriment serju talfwied*#
English: A KRAS mutation was reported in 57% of patients at study entry.
Maltese: Mutazzjoni KRAS kienet irrappurtata f'57% tal-pazjenti mad-dħul fl-istudju.
English: A higher incidence of hand foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome, severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga compared with Caucasians.
Maltese: hand foot skin reaction)/sindrome ta' eritrodisestesija palmari-plantari, anormalitajiet severi fit-test tal-funzjoni tal-fwied u disfunzjoni tal-fwied, ġiet osservata f'pazjenti Asjatiċi (b'mod partikulari
English: Taste disorders Dry mouth Gastrooesophageal reflux Gastroenteritis
Maltese: Rifluss gastroesofagali Gastroenterite
English: Metastatic colorectal cancer (CRC)
Maltese: Kanċer metastatiku tal-kolon u tar-rektum (CRC)
English: A second phase III, international, multi-centre, randomised, double blind, placebo-controlled study (CONCUR) evaluated the efficacy and safety of Stivarga in 204 pre-treated Asian patients (> 90% East Asian) with metastatic colorectal cancer who have progressed after failure of fluoropyrimidinebased chemotherapy.
Maltese: III, internazzjonali, multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo (CONCUR), evalwa l-effikaċja u s-sigurtà ta' Stivarga f'204 pazjenti Asjatiċi kkurati minn qabel (> 90% mill-Asja tal-Lvant) b'kanċer metastatiku talkolorektum li kellhom progressjoni wara falliment ta' kimoterapija bbażata fuq fluoropyrimidine.
English: 5.0 months
Maltese: 5.0 xhur
English: NA Best Supportive Care Hazard ratio < 1 favours Stivarga ** based on investigator's assessment of tumour response by modified RECIST Response rate (complete or partial response), DCR (complete response, partial response and stable disease maintained for 6 weeks)
Maltese: Proporzjon ta' Periklu < 1 favur Stivarga ** ibbażat fuq valutazzjoni tal-investigatur tar-rispons tat-tumur skont RECIST modifikat Rata ta' Rispons (rispons komplut jew parzjali), DCR (rispons komplut, rispons parzjali u marda stabbli miżmuma għal 6 ġimgħat)
English: * fatal cases have been reported ** palmar-plantar erythrodysesthesia syndrome in MedDRA terminology # according to drug-induced liver injury (DILI) criteria of the international DILI expert working group
Maltese: # skont il-kriterju ta' korriment tal-fwied indott mill-mediċina(DILI - drug-induced liver injury) tal grupp internazzjonali ta' esperti li qed jaħdmu fuq DILI
English: You will usually take Stivarga as long as you are benefiting and not suffering unacceptable side effects.
Maltese: Normalment se tieħu Stivarga sakemm tkun qed tibbenefika u ma tkunx qed issofri effetti sekondarji inaċċettabbli.
English: The hazard ratio (95% CI) of OS was 0.653 (0.476 to 0.895) for patients with KRAS wild-type tumours and 0.867 (0.670 to 1.123) for patients with KRAS mutant tumours, with no evidence of heterogeneity in treatment effect (non-significant interaction test).
Maltese: KRAS tat-tip selvaġġ u ta' 0.867 (0.670 sa 1.123) għall-pazjenti b'tumuri bi KRAS mutant, bl-ebda evidenza ta' eteroġeneità fl-effett tal-kura (test ta' interazzjoni mhux sinifikanti).
English: Administration of regorafenib with a 5-day break prior to administration of irinotecan resulted in an increase of approximately 44% in AUC of SN-38, a substrate of UGT1A1 and an active metabolite of irinotecan.
Maltese: L-għoti ta' regorafenib b'waqfa ta' 5 ijiem qabel l-għoti ta' irinotecan wassal għal żieda ta' madwar 44% fl-AUC ta' SN-38, substrat ta' UGT1A1
English: In preclinical studies regorafenib has demonstrated potent antitumour activity in a broad spectrum of tumour models including colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects.
Maltese: Fi studji ta' qabel l-użu kliniku regorafenib wera attività potenti kontra t-tumur f'firxa wiesa' ta' mudelli ta' tumuri inkluż mudelli ta' tumur tal-kolon u tar-rektum, tal-istroma gastro-intestinali u epatoċellulari li x'aktarx huwa medjat mill-effetti anti-anġjoġeneċi u anti-proliferattivi tiegħu.
English: Stivarga 40 mg tablets are light pink and oval, marked with “BAYER” on one side and “40” on the other side.
Maltese: Pilloli Stivarga 40 mg huma roża ċari u ovali, immarkati b'“BAYER” fuq naħa waħda u “40” fuq innaħa l-oħra.
English: The addition of Stivarga to BSC resulted in a significantly longer survival, compared to placebo plus BSC with a hazard ratio of 0.550 (p = 0.000159 stratified log rank test) and a median OS of 8.8 months vs. 6.3 months [95% CI 0.395, 0.765].
Maltese: (p = 0.000159 test log rank stratifikat) u OS medjana ta' 8.8 xhur vs. 6.3 xhur [CI ta' 95% 0.395, 0.765].
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between patients with mild hepatic impairment (Child-Pugh A) and normal hepatic function.
Maltese: Fi studji kliniċi, ma kienet osservata l-ebda differenza rilevanti fl-esponiment, fis-sigurtà jew fl effikaċja bejn pazjenti b'indeboliment epatiku ħafif (Child-Pugh A) u dawk b'funzjoni epatika normali.
English: The most serious adverse drug reactions in patients receiving Stivarga are severe liver injury, haemorrhage, gastrointestinal perforation and infection.
Maltese: - Problemi severi fil-fwied, fsada, perforazzjoni gastro-intestinali u infezzjoni.
English: In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients treated with Stivarga, compared to patients receiving placebo (29.6% vs. 7.5% CRC, 60.6% vs. 25.8% GIST and 31.0% vs. 6.2% HCC).
Maltese: III ikkontrollati bil-plaċebo, l-inċidenza globali ta' pressjoni għolja kienet ogħla f'pazjenti ttrattati b'Stivarga, meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo (29.6% kontra 7.5% CRC, 60.6% kontra 25.
English: § Best Supportive Care * Hazard ratio < 1 favours Stivarga ** NR: not reached
Maltese: L-Aħjar kura ta' appoġġ * Proporzjon ta' periklu < 1 jiffavorixxi Stivarga
English: There is insufficient data on patients who discontinued sorafenib therapy due to sorafenib-related toxicity or only tolerated a low dose (< 400 mg daily) of sorafenib.
Maltese: Hemm data insuffiċjenti dwar pazjenti li waqqfu t-terapija ta' sorafenib minħabba tossiċità relatata ma' sorafenib jew li ttolleraw biss doża baxxa (< 400 mg kuljum) ta' sorafenib.
English: When re-starting treatment, decrease dose by 40 mg (one tablet).
Maltese: Meta terġa' tibda l-kura, naqqas id-doża b'40 mg (pillola waħda).
English: Alopecia Dry skin Exfoliative rash
Maltese: Alopeċja Ġilda xotta
English: Following oral administration, mean elimination half-life for regorafenib and its metabolite M-2 in plasma ranges from 20 to 30 hours in different studies.
Maltese: Wara għoti mill-ħalq, il-half life medja tal-eliminazzjoni ta' regorafenib u tal-metabolit tiegħu M-2 filplażma tvarja minn 20 sa 30 siegħa fi studji differenti.
English: 3rd occurrence Discontinue treatment with Stivarga permanently.
Maltese: Waqqaf il-kura b'Stivarga b'mod permanenti.
English: Taking too much Stivarga may make some side effects more likely or more severe, especially: - skin reactions (rash, blisters, redness, pain, swelling, itching or peeling of your skin) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - mouth sores (mucosal inflammation)
Maltese: Teħid żejjed ta' Stivarga jista' jżid il-probabbiltà jew is-severità ta' xi effetti sekondarji, speċjalment: - reazzjonijiet fil-ġilda (raxx, infafet, ħmura, uġigħ, nefħa, ħakk jew tqaxxir tal-ġilda tiegħek) - bidliet fil-vuċi jew ħanqa (disfonija) - movimenti tal-imsaren frekwenti jew maħlula (dijarea) - feriti fil-ħalq (infjammazzjoni fil-mukuża) - ħalq xott
English: Figure 3: Kaplan-Meier curves of OS
Maltese: Kaplan-Meier tal-OS
English: A clinical probe substrate study was performed to evaluate the effect of 14 days of dosing with 160 mg regorafenib on the pharmacokinetics of probe substrates of CYP2C8 (rosiglitazone) CYP2C9 (S-warfarin), CYP 2C19 (omeprazole) and CYP3A4 (midazolam).
Maltese: Sar studju kliniku investigattiv ta' sustrat biex jiġi evalwat l-effett ta' 14-il ġurnata ta' dożaġġ b'160 mg regorafenib fuq il-farmakokinetika ta' sustrati taħt investigazzjoni ta' CYP2C8
English: Only 59.5 % of patients enrolled in the CONCUR study were also previously treated with VEGF- or EGFR-targeted agents.
Maltese: 59.5% biss tal-pazjenti rreġistrati fl-istudju CONCUR kienu wkoll ikkurati fil-passat b'mediċini li jimmiraw VEGF jew EGFR.
English: Of the 199 randomised patients, the mean age was 58 years, 64% were male, 68% were Caucasian, and all patients had baseline ECOG Performance Status (PS of 0 or 1.
Maltese: Mill-199 pazjent randomised, l-età medja kienet ta' 58 sena, 64% kienu rġiel, 68% kienu Kawkażi, u l pazjenti kollha kellhom
English: Regorafenib reaches mean peak plasma levels of about 2.5 mg/l at about 3 to 4 hours after a single oral dose of 160 mg given as 4 tablets each containing 40 mg.
Maltese: Regorafenib jilħaq livelli massimi medji fil-plażma ta' madwar 2.5 mg/l f'madwar 3 sa 4 sigħat wara doża orali waħda ta' 160 mg mogħtija bħala 4 pilloli li kull waħda fiha 40 mg.
English: Both metabolites, M-2 and M-5, exhibit non-linear accumulation, which might be caused by enterohepatic recycling or saturation of the UGT1A9 pathway.
Maltese: Iż-żewġ metaboliti, M-2 u M-5, juru akkumulazzjoni mhux lineari, li tista' tkun ikkawżata minn riċiklaġg entero-epatiku jew saturazzjoni tar-rotta UGT1A9.
English: 10.6 months
Maltese: 10.6 xhur
English: In the placebo-controlled phase III trials, the overall incidence of haemorrhage was 18.2% in patients treated with Stivarga and 9.5% in patients receiving placebo.
Maltese: III ikkontrollati bil-plaċebo, l-inċidenza globali ta' emorraġija kienet ta' 18.2% f'pazjenti kkurati b'Stivarga u 9.5% f'pazjenti li kienu qed jirċievu plaċebo.
English: Patients receiving regorafenib who experienced disease progression and for whom in the investigator's opinion, treatment with regorafenib was providing clinical benefit, were offered the opportunity to continue open-label regorafenib.
Maltese: Pazjenti li kienu qed jirċievu regorafenib li esperjenzaw progressjoni tal-marda u li għalihom fl-opinjoni tal-investigatur, il-kura b'regorafenib kienet qed tipprovdi benefiċċju kliniku, kienu offruti l-opportunità li jkomplu b'regorafenib open-label.
English: Following single doses of 60 mg or 100 mg, the average relative bioavailability of tablets compared to an oral solution was 69% and 83%, respectively.
Maltese: 60 mg jew100 mg, il-bijodisponibiltà relattiva medja tal-pilloli mqabbla ma' soluzzjoni orali kienet ta'
English: The mean daily regorafenib dose received was 140 mg.
Maltese: Id-doża medja ta' kuljum ta' regorafenib riċevuta kienet ta' 140 mg.
English: In vitro data indicate that regorafenib as well as its active metabolite M-2 inhibit glucuronidation mediated by UGT1A1 and UGT1A9 whereas M-5 only inhibits UGT1A1 at concentrations which are achieved in vivo at steady state.
Maltese: Dejta in vitro tindika li regorafenib kif ukoll il-metabolit attiv tiegħu M-2 jinibixxu l glukuronidazzjoni medjata minn UGT1A1 u UGT1A9 filwaqt li M-5 jinibixxi UGT1A1 biss f'konċentrazzjonijiet li huma miksuba in vivo fi stat fiss.
English: Grade
Maltese: PROVVISTA
English: 6.3 Shelf life
Maltese: 3.2 xhur
English: PFS was also significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.311, p<0.000001), median PFS 3.2 months with Stivarga vs. 1.7 months with placebo.
Maltese: PFS kienet ukoll itwal b'mod sinifikanti f'pazjenti li kienu qed jirċievu Stivarga flimkien ma' BSC (proporzjon ta' periklu: 0.311, p<0.000001), PFS medjana ta' 3.2 xhur b'Stivarga vs.
English: In total, 760 patients were randomised 2:1 to receive 160 mg regorafenib (4 tablets Stivarga each containing 40 mg regorafenib) orally once daily (N=505) plus Best Supportive Care (BSC or matching placebo (N=255) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
Maltese: B'kollox, 760 pazjent kienu randomised 2:1 biex jirċievu 160 mg regorafenib (4 pilloli Stivarga li kull waħda fiha 40 mg regorafenib) mill-ħalq darba kuljum (N=505) flimkien mal-Aħjar
English: Most patients (52%) received 3 or fewer previous lines of treatment for metastatic disease.
Maltese: Il-maġġoranza tal-pazjenti (52%) irċevew 3 jew inqas linji preċedenti ta' kura għall-marda metastatika.
English: Hypokalaemia Hypophosphatemia Hypocalcaemia Hyponatraemia Hypomagnesaemia Hyperuricaemia Dehydration
Maltese: - tgħaddi demm fl-ippurgar jew tgħaddi ippurgar iswed - tgħaddi demm fl-awrina
English: Stivarga plus BSC (n= 500)
Maltese: Stivarga (N=505)
English: Results from animal studies indicate that regorafenib can impair male and female fertility (see section 5.3).
Maltese: Riżultati minn studji fuq l-annimali jindikaw li regorafenib jista' jtellef il-fertilità maskili u femminili (ara sezzjoni 5.3).
English: In addition, 56 placebo plus BSC patients received open-label Stivarga after cross-over following disease progression and a total of 41 Stivarga plus BSC patients continued Stivarga treatment after disease progression.
Maltese: Barra dan, 56 pazjent fuq plaċebo flimkien ma' BSC ħadu Stivarga open-label wara cross-over minħabba progressjoni tal-marda u total ta' 41 pazjent fuq Stivarga flimkien ma' BSC komplew il kura b'Stivarga wara progressjoni tal-marda.
English: Other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital and St. John's wort) may also increase metabolism of regorafenib.
Maltese: (eż. phenytoin, carbamazepine, phenobarbital u St.
English: Package Leaflet: Information for the user Stivarga 40 mg film-coated tablets regorafenib
Maltese: Informazzjoni għall-utent Stivarga 40 mg pilloli miksija b'rita regorafenib
English: No QTc prolonging effects were observed after administration of 160 mg regorafenib at steady state in a dedicated QT study in male and female cancer patients.
Maltese: Ma kienux osservati effetti ta' titwil ta' QTc wara għoti ta' 160 mg regorafenib fi stat fiss fi studju dwar QT f'pazjenti maskili u femminili bil-kanċer.
English: Table 4a: Treatment emergent liver enzyme test abnormalities reported in placebo-controlled phase III trial in Asian patients with metastatic CRC (CONCUR)
Maltese: Tabella 4a: Anormalitajiet fit-testijiet tal-laboratorju tal-enzimi tal-fwied li dehru mal-kura rrappurtati fil-prova ta' fażi
English: These may be signs of an infection.
Maltese: Dawn jistgħu jkunu sinjali ta' infezzjoni.
English: Muscle spasms
Maltese: Stivarga Plaċebo
English: Take special care with Stivarga
Maltese: Pazjenti f'Riskju Stivarga
English: • ECOG Performance Status (PS) of 0: 66% or ECOG PS of 1: 34%
Maltese: Stat ta' Ħila (PS - Performance Status) ta' ECOG fil-linja bażi ta' 0 jew 1.
English: Figure 4: Kaplan-Meier curve of OS
Maltese: Kaplan-Meier ta' OS
English: Concentration of free triiodothyronine (FT3) post baseline below lower limit of normal (<LLN) was reported in 29.2% of patients treated with Stivarga and in 20.4% of patients receiving placebo.
Maltese: Konċentrazzjoni ta' triiodothyronine ħieles (FT3 - free triiodothyronine) taħt il-limitu l-aktar baxx tannormal (<LLN - below lower limit of normal) wara l-linja bażi kienet irrappurtata f'29.2% tal-pazjenti kkurati b'Stivarga u f'20.
English: An increase in AUC of irinotecan of approximately 28% was also observed.
Maltese: Kienet osservata wkoll żieda ta' madwar 28% fl-AUC ta' irinotecan.
English: In particular, regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation.
Maltese: B'mod partikolari, regorafenib jinibixxi KIT mutat, fattur onkoġeniku maġġuri f'tumuri talistroma gastro-intestinali, u b'hekk jimblokka l-proliferazzjoni taċ-ċelluli tat-tumur.
English: An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat).
Maltese: Eżempji ta' ikla ħafifa (kontenut ta' xaħam baxx) jinkludu porzjon wieħed ta' ċereali (madwar 30 g), tazza waħda ta' ħalib xkumat, porzjon wieħed ta' ħobż mixwi bil-ġamm, tazza waħda ta' meraq tat-tuffieħ, u kikkra waħda ta' kafè jew tè (520 kalorija, 2 g xaħam).
English: In total, 199 patients with GIST were randomised 2:1 to receive either 160 mg regorafenib plus Best Supportive Care (BSC) (N=133) orally once daily or matching placebo plus BSC (N=66) for 3 weeks on therapy followed by 1 week off therapy.
Maltese: Aħjar Kura ta' Appoġġ (BSC - Best Supportive Care; N=133) mill-ħalq darba kuljum jew plaċebo li jikkorrispondi flimkien ma' BSC (N=66) għal 3 ġimgħat fuq terapija segwit minn ġimgħa waħda mingħajr terapija.
English: The most frequently observed adverse drug reactions at this dose were dermatological events, dysphonia, diarrhoea, mucosal inflammation, dry mouth, decreased appetite, hypertension, and fatigue.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina osservati b'mod frekwenti b'din id-doża kienu avvenimenti dermatoloġiċi, disfonija, dijarea, infjammazzjoni tal-mukuża, ħalq xott, tnaqqis fl-aptit, pressjoni għolja, u għeja.
English: The safety and efficacy of Stivarga in children and adolescents in the indication of gastrointestinal stromal tumours (GIST) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Stivarga fi tfal u adolexxenti fl-indikazzjoni ta' tumuri tal-istroma gastrointestinali (GIST) ma ġewx determinati s'issa.
English: These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Maltese: Dawn l-avvenimenti huma magħrufa wkoll li huma komplikazzjonijiet komuni relatati mal-marda f'pazjenti b'tumuni intra-addominali malinni.
English: Bayer S.p.A. Tel: +39-02-397 81
Maltese: Tel: +39-02-397 81
English: Fatal outcomes associated with infection were observed more often in patients treated with Stivarga (1.0%), compared to patients receiving placebo (0.3%), and were mainly respiratory events.
Maltese: Riżultati fatali assoċjati ma' infezzjoni kienu osservati aktar ta' spiss f'pazjenti ttrattati b'Stivarga (1.0%), meta mqabbla ma' pazjenti li rċevew plaċebo (0.3%), u fil-biċċa l-kbira kienu avvenimenti respiratorja.
English: There is limited data on regorafenib in the black patient population.
Maltese: Hemm dejta limitata dwar regorafenib fil-popolazzjoni ta' pazjenti suwed.
English: Interrupt therapy until toxicity resolves to Grade 0-1.
Maltese: waqqaf it-terapija għal tal-inqas 7 ijiem, sakemm it-tossiċità titjieb għal Grad 0-1.
English: In particular, tell your doctor if you are taking anything in this list or any other medicines: - some medicines to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole and voriconazole) - some medicines to treat pain (e.g. mefenamic acid, diflunisal, and niflumic acid) - some medicines to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin) - medicines typically used to treat epilepsy (seizures) (e.g. phenytoin, carbamazepine or phenobarbital) - methotrexate, a medicine typically used to treat cancer - rosuvastatin, fluvastatin, atorvastatin, medicines typically used to treat high cholesterol - warfarin or phenprocoumon, medicines typically used to thin your blood - St. John's wort (medicine obtained also without a prescription), a herbal treatment for depression.
Maltese: - sinjali/sintomi ta' reazzjoni allerġika li jistgħu jinkludu raxx mifrux u sever, tħossok se tirremetti, deni, qtugħ ta' nifs, suffejra, bidliet fil-kimiċi magħmula mill-fwied (reazzjoni ta' sensittività eċċessiva) - attakk tal-qalb, uġigħ fis-sider (infart u iskemija mijokardijaka) - pressjoni għolja b'mod sever li tikkawża uġigħ ta' ras, konfużjoni, vista mċajpra, tqalligħ, rimettar, u aċċessjonijiet (kriżi ipertensiva) - infjammazzjoni tal-frixa kkaratterizzata minn uġigħ fiż-żona tal-istonku, dardir, rimettar u deni
English: The exposure of metabolites M-2 (N-oxide) and M-5 (N-oxide and N-desmethyl) is higher when regorafenib is given with a low fat breakfast, compared to fasting condition and lower when given with a high fat meal, compared to fasting condition.
Maltese: M-2 (N-oxide) u M-5 (N-oxide u N-desmethyl) huwa ogħla meta regorafenib jingħata ma' kolazzjon bi ftit xaħmijiet meta mqabbel ma' stat sajjem u inqas meta jingħata ma' ikla b'ħafna xaħmijiet meta mqabbel ma' stat sajjem.
English: Blood and lymphatic system disorders
Maltese: Cellulose microcrystalline
English: Store in the original package in order to protect from moisture.
Maltese: Sustanzi antineoplastiċi, inibitur ta' protein kinase;
English: Each film-coated tablet contains 40 mg regorafenib.
Maltese: Kull pillola miksija b'rita fiha 40 mg ta' regorafenib.
English: It is recommended to monitor biochemical and metabolic parameters during Stivarga treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Maltese: Huwa rrakkomandat li l-parametri bijokimiċi u metaboliċi jiġu ssorveljati waqt kura b'Stivarga u jekk meħtieġ għandha tinbeda terapija ta' sostituzzjoni xierqa skont il-prattika klinika normali.