FrancophonIA/ELRC3.0 huggingface dataset:
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Maltese: • effett negattiv fuq il-ħila ta' mara biex ikollha t-tfal (ara l-paragrafi taħt il-lista ta' effetti sekondarji għal aktar rakkomandazzjonijiet),
English: These therapies in combination with Zirabev may increase the risk of severe side effects.
Maltese: Dawn it-terapiji flimkien ma' Zirabev jistgħu jżidu r-riskju ta' effetti sekondarji severi.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detenur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive,
Maltese: • infjammazzjoni tal-kisja niedja tal-ħalq u l-musrana, pulmun u l-passaġġi tal-arja, apparat riproduttiv u tal-awrina,
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and young adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Maltese: Irriżultati farmakokinetiċi juru li t-tneħħija u l-volum ta' distribuzzjoni ta' bevacizumab kienu komparabbli bejn pazjenti pedjatriċi u adulti meta normalizzati skont il-piż tal-ġisem.
English: Chemotherapy + bevacizumab (n=227)
Maltese: Kimoterapija + bevacizumab (n=227)
English: • Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Maltese: • Sensittività eċċessiva għal prodotti taċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO - Chinese
English: Zirabev will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Maltese: Zirabev se jingħata flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan lil pazjenti li ma jistgħux jirċievu terapija bi platinu.
English: The clinical benefit of bevacizumab as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and oestrogen receptor (ER) status).
Maltese: Il-benefiċċju kliniku ta' bevacizumab kif imkejjel mill-PFS deher fis-sottogruppi taħt studju, speċifikati minn qabel, kollha (inkluż intervall mingħajr il-marda, numru ta' postijiet b'metastasi, kimoterapija awżiljarja li ngħatat minn qabel, u stat ta' riċettur għall-estroġen (ER)).
English: ● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Maltese: ● Din il-mediċina tista' żżid ir-riskju ta' fsada jew iżżid ir-riskju ta' problemi bil-fejqan talferiti wara kirurġija.
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Maltese: Mudell esploratorju multivarjabbli ta' rigressjoni Cox bl-użu ta' selezzjoni b'lura indika li l-fatturi pronostiċi fil-linja bażi li ġejjin kienu assoċjati b'mod qawwi mas-sopravivenza b'mod mhux dipendenti mill-kura: sess, għadd taċ-ċelluli bojod tad-demm, plejtlits, telf tal-piż tal-ġisem fis6 xhur qabel id-dħul fil-prova, numru ta' siti metastatiċi, għadd tal-itwal dijametru tal-leżjonijiet immirati, punteġġ ta' Motzer.
English: In patients developing PRES, early recognition of symptoms with prompt treatment of specific symptoms including control of hypertension (if associated with severe uncontrolled hypertension) is recommended in addition to discontinuation of bevacizumab therapy.
Maltese: F'pazjenti li qed jiżviluppaw PRES, għarfien bikri tas-sintomi flimkien ma' kura immedjata ta' sintomi speċifiċi inkluż kontroll ta' pressjoni għolja (jekk assoċjati ma' pressjoni għolja severa mhux ikkontrollata) huwa rrakkomandat flimkien ma' waqfien tat-terapija b'bevacizumab.
English: Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Zirabev.
Maltese: Għalhekk, strateġiji ta' preservazzjoni tal-fertilità għandhom jiġu diskussi ma' nisa li jista' jkollhom it-tfal qabel ma jibdew il-kura b'Zirabev.
English: Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
Maltese: Rikorrenza ta' kanċer fl-ambjent ta' radjazzjoni minn qabel huwa fattur ta' riskju importanti addizzjonali għall-iżvilupp ta' fistuli GI-vaġinali.
English: Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab.
Maltese: Il-pazjenti jistgħu jkunu f'riskju akbar li jiżviluppaw perforazzjoni gastrointestinali u perforazzjoni tal-marrara meta kkurati b'bevacizumab.
English: Non-GI fistulae (see section 4.4)
Maltese: Pressjoni għolja (ara sezzjoni 4.4)
English: Overall survival Median (months) Hazard ratio 95% CI
Maltese: Numru ta' pazjenti Sopravivenza totali Medjan (xhur) 95% CI
English: In NSABP C-08, a phase III trial of bevacizumab in adjuvant treatment of patients with colon cancer, the incidence of new cases of ovarian failure, defined as amenorrhoea lasting 3 or more months, FSH level ≥ 30 mIU/mL and a negative serum β-HCG pregnancy test, has been evaluated in 295 premenopausal women.
Maltese: III ta' bevacizumab fil-kura awżiljarja ta' pazjenti b'kanċer tal-kolon, l-inċidenza ta' każijiet ġodda ta' insuffiċjenza tal-ovarji, definita bħala amenorrea li ddum 3 xhur jew aktar, livell ta' FSH ta' ≥ 30 mIU/ml u test tat-tqala b'β-HCG fis-serum negattiv, ġiet evalwata f'295 mara li kienu għadhom m'għaddewx mill-menopawża.
English: In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Maltese: Fil-fniek, bevacizumab intwera li jinibixxi l-fejqan tal-feritai f'dożi inqas mid-doża klinika proposta.
English: The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving bevacizumab in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Maltese: L-inċidenza ta' reazzjonijiet tromboemboliċi venużi fi provi kliniċi kienet simili f'pazjenti li kienu qed jirċievu bevacizumab flimkien ma' kimoterapija kienet simili għal dawk tal-kontroll li rċievew kimoterapija biss.
English: • Male: 88%
Maltese: • Irġiel: 88%
English: EU/1/13/858/001 EU/1/13/858/002
Maltese: EU/1/13/858/002
English: Grade b All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Maltese: Gradi kollha % Grad 3/4 % Gradi kollha % Grad 3/4 % Gradi kollha % Grad 3/4 %
English: Grade a
Maltese: Grad a
English: • Median age: 63 years
Maltese: • Età medjana: 63 sena
English: Dermatological toxicity
Maltese: Tossiċità dermatoloġika
English: Grade b
Maltese: Grad b
English: - The active substance is regorafenib.
Maltese: - Is-sustanza attiva hi regorafenib.
English: 0.005178 6.4 months
Maltese: 0.005178 6.4 xhur
English: • Caucasian: 36%, Asian: 41%
Maltese: 36%, Asjatiċi: 41%
English: <0.000001 1.9 months
Maltese: <0.000001 1.9 xhur
English: ≤5 times upper limit of normal (ULN) (maximum Grade 2)
Maltese: ≤5 darbiet il-limitu ta' fuq tan-normal (ULN) (massimu Grad 2)
English: >20 times ULN (Grade 4)
Maltese: >20 darba ULN (Grad 4)
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 13%; BCLC stage C: 87%
Maltese: • Kanċer tal-Fwied tal-Klinika ta' Barcelona (BCLC - Barcelona Clinic Liver Cancer) Stadju B: 13%; BCLC stadju C: 87%
English: Bayer AG
Maltese: Manifattur Bayer AG
English: Iron oxide red (E172) Iron oxide yellow (E172) Lecithin (derived from soya) Macrogol 3350
Maltese: Iron oxide isfar (E172) Lecithin (derivat mis-sojja) Macrogol 3350
English: System Organ Class (MedDRA)
Maltese: Organi (MedDRA)
English: • Aetiology included Hepatitis B (38%), Hepatitis C (21%), Non-Alcoholic Steato Hepatitis
Maltese: • Etjoloġija inklużi Epatite B (38%), Epatite C (21%), Epatite Steato Mhux Alkoħolika (NASH
English: Polyvinyl alcohol, partially hydrolysed Talc
Maltese: Polyvinyl alcohol, parzjalment idrolizzat
English: Stivarga contains the active substance regorafenib.
Maltese: Stivarga fih is-sustanza attiva regorafenib.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2018
English: Gastrointestinal perforation* Gastrointestinal fistula Pancreatitis
Maltese: Perforazzjoni gastrointestinali* Fistula gastrointestinali Pankreatite
English: >5 times ULN ≤20 times ULN (Grade 3)
Maltese: > 5 darbiet ULN ≤20 darba ULN (Grad 3)
English: Inhibitors of CYP3A4 and UGT1A9/inducers of CYP3A4
Maltese: Inibituri ta' CYP3A4 u UGT1A9/induttutri ta' CYP3A4
English: Bayer HealthCare Tél: +33-(0)800 87 54 54
Maltese: Tél: +33-(0)800 87 54 54
English: Regorafenib is a uridine diphosphate glucuronosyl transferase (UGT) 1A1 inhibitor (see section 4.5).
Maltese: Regorafenib huwa inibitur ta' uridine diphosphate glucuronosyl transferase (UGT) 1A1 (ara sezzjoni 4.5).
English: Posterior reversible encephalopathy syndrome (PRES)
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome)
English: Elderly Age did not affect the regorafenib pharmacokinetics over the studied age range (29 - 85 years).
Maltese: Anzjani L-età ma affettwatx il-farmakokinetika ta' regorafenib fuq il-firxa ta' età studjata (29 - 85 sena).
English: Pharmacokinetic interactions of other antibiotics have not been studied.
Maltese: Ma ġewx studjati interazzjonijiet farmakokinetiċi ta' antibijotiċi oħra.
English: • Loco-regional transarterial embolisation or chemoinfusion procedures: 61%
Maltese: • Embolizazzjoni transarterjali loko-reġjonali jew proċeduri ta' kimoinfużjoni: 61%
English: Myocardial infarction Myocardial ischaemia
Maltese: Infart mijokardijaku Iskemija mijokardijaka
English: UGT1A1 and UGT1A9 substrates
Maltese: Sustrati UGT1A1 u UGT1A9
English: PS ≥2 was reported during Stivarga treatment in 11.4% of patients.
Maltese: Waqt kura b'Stivarga PS ta' ≥2 kien irrappurtat fi 11.4% tal-pazjenti.
English: Laboratory parameter, (in % of samples investigated)
Maltese: Parametru tal laboratorju, (f'% talkampjuni investigati)
English: - The other ingredients are: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone (K-25) and silica colloidal anhydrous, iron oxide red (E172), iron oxide yellow (E172), lecithin (derived from soya), macrogol 3350, polyvinyl alcohol (partially hydrolysed), talc and titanium dioxide (E171) (see also section ‘Important information about some of the ingredients of Stivarga').
Maltese: - Is-sustanzi l-oħra huma: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone (K-25) u silica colloidal anhydrous, iron oxide aħmar (E172), iron oxide isfar (E172), lecithin (derivat mis-sojja), macrogol 3350, alkoħol polyvinyl (parzjalment idrolizzat), talk u titanium dioxide (E171) (ara wkoll is-sezzjoni ‘Tagħrif importanti dwar xi wħud mill-eċċippjenti ta' Stivarga').
English: The recommended daily dose in adults is 4 tablets of Stivarga 40 mg (160 mg regorafenib).
Maltese: Id-doża rakkomandata ta' kuljum fl-adulti hija 4 pilloli ta' Stivarga 40 mg (160 mg regorafenib).
English: Cellulose microcrystalline Croscarmellose sodium Magnesium stearate Povidone (K-25) Silica, colloidal anhydrous
Maltese: Croscarmellose sodium Magnesium stearate Povidone (K-25)
English: Titanium dioxide (E171)
Maltese: TalkTitanium dioxide (E171) 6.2 Inkompatibbiltajiet
English: Secondary endpoints including Time To Progression (TTP) and Overall Survival (OS (interim analysis) were also assessed.
Maltese: Kienu evalwati wkoll punti finali sekondarji inkluż Żmien sal-Progressjoni (TTP - Time To Progression) u Sopravivenza Globali (OS - Overall Survival) (analiżi interim).
English: Frequency groups are defined by the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and not known (cannot be estimated from the available data).
Maltese: Gruppi ta' frekwenza huma definiti skont il-konvenzjoni li ġejja: 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) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Hazard ratio* (95% CI)
Maltese: Medjan (95% CI)
English: Contains sodium and lecithin (derived from soya).
Maltese: Fih sodium u lecithin (derivat mis-sojja).
English: StevensJohnson syndrome Toxic epidermal necrolysis
Maltese: Sindrome ta' Stevens Johnson Nekrolisi tossika talepidermide
English: In vitro protein binding of M-2 and M-5 is higher (99.8% and 99.95%, respectively) than that of regorafenib.
Maltese: In vitro it-twaħħil mal-proteini ta' M-2 u M-5 huwa ogħla (99.8% u 99.95%, rispettivament) minn dak ta' regorafenib.
English: There is limited data in patients with PS ≥2.
Maltese: Hemm dejta limitata f'pazjenti li għandhom PS ta' ≥2.
English: Limited data in patients with moderate hepatic impairment (Child-Pugh B) indicate similar exposure, compared to patients with normal hepatic function after a single 100 mg dose of regorafenib.
Maltese: Dejta limitata f'pazjenti b'indeboliment epatiku moderat (Child-Pugh B) tindika esponiment simili meta mqabbla ma' pazjenti b'funzjoni epatika normali wara doża waħda ta' 100 mg regorafenib.
English: • Absence of both macroscopic vascular invasion and extra-hepatic tumour spread: 19%
Maltese: • Nuqqas ta' invażjoni vaskulari makroskopika u ta' firxa tat-tumur barra mill-fwied: 19%
English: The primary site of disease was colon (65%), rectum (29%), or both (6%).
Maltese: Is-sit primarju tal-marda kien il-kolon (65%), ir-rektum (29%), jew it-tnejn (6%).
English: 28 film-coated tablets 84 (3 x 28) film-coated tablets
Maltese: 28 pillola miksija b'rita 84 (3 x 28) pillola miksija b'rita
English: Efficacy parameter
Maltese: Parametri talEffikaċja
English: The incidence of Grade 3 hand-foot skin reaction in Asians was 20.5% (CRC), 23.5% (GIST) and 13.5% (HCC) (see sections 4.2 and 4.4).
Maltese: 5% (CRC), 23.5% (GIST) u 13.5% (HCC) (ara sezzjonijiet 4.2 u 4.4).
English: Figure 5: Kaplan-Meier curve of PFS (mRECIST)
Maltese: Kaplan-Meier ta' PFS (mRECIST)
English: Laboratory Parameter (in % of samples investigated)
Maltese: Parametru tal-laboratorju (f'% ta' kampjuni investigati)
English: Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
Maltese: Kull doża ta' kuljum ta' 160 mg fiha 2.427 mmol (jew 55.8 mg) ta' sodium (ara sezzjoni 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu
Maltese: Mediċini: http://www.ema.europa.eu.
English: M-5 (N-oxide and N-desmethyl), of approximately 90%.
Maltese: (N-oxide) u M-5 (N-oxide u N-desmethyl).
English: Pharmacokinetic data indicate that regorafenib may be given concomitantly with substrates of CYP2C8, CYP2C9, CYP3A4, and CYP2C19 without a clinically meaningful drug interaction (see also section 4.4).
Maltese: Dejta farmakokinetika tindika li regorafenib jista' jingħata flimkien ma' sustrati ta' CYP2C8, CYP2C9, CYP3A4, u CYP2C19 mingħajr interazzjoni klinikament sinifikanti tal-mediċina (ara wkoll sezzjoni 4.4).
English: M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
Maltese: M-5 jista' jiġi mnaqqas għal M-4 fl-apparat gastro-intestinali mill-flora ta' mikrobi, u dan jippermetti assorbiment mill-ġdid ta' M-4 (ċirkolazzjoni entero-epatika).
English: The in vitro inhibitory potency towards CYP3A4 (Ki value of 11.1 micromolar) and CYP2C19 (Ki value of 16.4 micromolar) was less pronounced.
Maltese: Il-qawwa inibitorja in vitro lejn CYP3A4 (valur Ki ta' 11.1 mikromolari) u CYP2C19 (valur Ki ta' 16.4 mikromolari) kienet inqas ovvja.
English: Mechanism of action and pharmacodynamic effects Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R).
Maltese: Regorafenib huwa sustanza orali li jneħħi l-attività tat-tumur billi jimblokka b'mod qawwi bosta protein kinases, inkluż kinases involuti fl-anġjoġenesi (VEGFR1, -2, -3, TIE2), fl-onkoġenesi (KIT, RET, RAF-1, BRAF, BRAF
English: Severe liver function test abnormalities (Grade 3 to 4) and hepatic dysfunction with clinical manifestations (including fatal outcomes) have been reported in a small proportion of patients (see section 4.8).
Maltese: Anormalitajiet severi fit-testijiet tal-funzjoni tal-fwied (Grad 3 sa 4) u disfunzjoni epatika b'manifestazzjonijiet kliniċi (inkluż riżultati fatali) kienu rrappurtati fi proporzjon żgħir ta' pazjenti (ara sezzjoni 4.8).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: The HR for OS was 0.772 (95% CI, 0.423, 1.408; p = 0.199; median OS not reached in either arm); 85% of patients initially randomised to the placebo arm received post-progression treatment with regorafenib (see Table 6, Figure 3).
Maltese: L-HR ta' OS kienet 0.772 (95% CI, 0.423, 1.408; p = 0.199; OS medjana ma ntlaħqet fl-ebda grupp); 85% tal-pazjenti li inizjalment kienu randomised għall-grupp tal-plaċebo rċevew kura wara lprogressjoni b'regorafenib (ara Tabella 6, Figura 3).
English: The main circulating metabolites of regorafenib in human plasma are M-2 (N-oxide) and M-5 (N-oxide and N-desmethyl), which are pharmacologically active and have similar concentrations as regorafenib at steady state.
Maltese: regorafenib li jiċċirkolaw fil-plażma umana huma M-2 (N-oxide) u M-5 (N-oxide u N-desmethyl), li huma farmakoloġikament attivi u li għandhom konċentrazzjonijiet simili għal regorafenib fi stat fiss.
English: The maximum daily dose is 160 mg.
Maltese: Id-doża massima ta' kuljum hija 160 mg.
English: Other side effects with Stivarga listed by frequency:
Maltese: Effetti sekondarji oħra b'Stivarga elenkati skont il-frekwenza:
English: • Child-Pugh A: 98%, Child-Pugh B: 2%
Maltese: • Status ta' Prestazzjoni (PS - Performance Status) ta' ECOG ta' 0: 66% jew PS ta' ECOG ta' 1: • Child-Pugh A: 98%, Child-Pugh B: 2%
English: Secondary endpoints were Progression-Free Survival (PFS), Time To Progression (TTP), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Maltese: Punti finali sekondarji kienu Sopravivenza Mingħajr Progressjoni (PFS - Progression-Free Survival), Żmien salProgressjoni (TTP - Time To Progression), Rata Oġġettiva ta' Rispons tat-Tumur (ORR - Objective Tumour Response Rate) u Rata ta' Kontroll tal-Marda (DCR - Disease Control Rate).
English: Stivarga plus BSC (n= 374)
Maltese: Stivarga flimkien ma' BSC (n= 374)
English: Pack of 84 (3 bottles of 28) film-coated tablets.
Maltese: Pakkett ta' 84 (3 fliexken ta' 28) pillola miksija b'rita.
English: The analysis of the primary efficacy endpoint Progression-Free Survival (PFS) was conducted after 144 PFS events (central blinded assessment).
Maltese: Progression-Free Survival) sar wara 144 avveniment ta' PFS (valutazzjoni ċentrali blinded).
English: The incidence of Grade 3 hand-foot skin reaction was 17.1% (CRC), 22.0% (GIST) and 12.3% (HCC).
Maltese: L-inċidenza ta' reazzjoni tal-ġilda tal-idejn u s-saqajn ta' Grad 3 kienet ta' 17.1% (CRC), 22.0% (GIST) u 12.3% (HCC).
English: In vitro data indicate that regorafenib is metabolized by cytochrome CYP3A4 and uridine diphosphate glucuronosyl transferase UGT1A9.
Maltese: Dejta in vitro tindika li regorafenib huwa metabolizzat miċ-ċitokromju CYP3A4 u minn uridine diphosphate glucuronosyl transferase UGT1A9.
English: There are no data on the effect of Stivarga on human fertility.
Maltese: M'hemmx dejta dwar l-effett ta' Stivarga fuq il-fertilità umana.
English: Hand-foot skin reaction** Rash
Maltese: Reazzjoni tal-ġilda tal-idejn u s-saqajn** Raxx
English: The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Maltese: PFS sekondarja medjana (kif imkejla mill-valutazzjoni tal-investigatur) kienet ta' 5.0 u 4.5 xhur, rispettivament.
English: ALT increased § Best Supportive Care * Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
Maltese: * Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE - Common Terminology Criteria for Adverse Events), Verżjoni 4.0
English: Avoid drinking grapefruit juice while taking Stivarga.
Maltese: Evita li tixrob meraq tal-grejpfrut waqt li qed tieħu Stivarga.
English: Your doctor may change your dose.
Maltese: Probabbiltà ta' Sopravivenza
English: Table 1: Recommended dose modifications and measures for HFSR Skin toxicity grade
Maltese: Tabella 1: Modifikazzjonijiet tad-doża u miżuri għal HFSR irrakkomandati Grad ta' tossiċità tal-ġilda
English: The hazard ratio (95% CI) of PFS was 0.475 (0.362 to 0.623) for patients with KRAS wild-type tumours and 0.525 (0.425 to 0.649) for patients with KRAS mutant tumours.
Maltese: Il-proporzjon ta' periklu (CI ta' 95%) ta' PFS kien ta' 0.475 (0.362 sa 0.623) għall-pazjenti b'tumuri bi KRAS tat-tip selvaġġ u ta' 0.525 (0.425 sa 0.649) għall-pazjenti b'tumuri bi KRAS mutant.
English: M-5 is finally excreted via M-4 as M-6 (carboxylic acid) in faeces.
Maltese: M-4 bħala M-6 (carboxylic acid) fl-ippurgar.
English: Other medicines and Stivarga
Maltese: Mediċini oħra u Stivarga
English: Gastrointestinal perforation (including fatal outcome) and fistulae have been reported in patients treated with Stivarga (see section 4.8).
Maltese: Perforazzjoni (inkluż riżultat fatali) u fistuli gastrointestinali kienu rrappurtati f'pazjenti trattati b'Stivarga (ara sezzjoni 4.8).
English: This medicine contains 1.68 mg of lecithin (derived from soya) per daily dose (4 tablets).
Maltese: Din il-mediċina fiha 1.68 mg ta' lecithin (derivat mis-sojja) f'kull doża ta' kuljum (4 pilloli).
English: Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4).
Maltese: Kull doża ta' kuljum ta' 160 mg fiha 1.68 mg ta' lecithin (derivat mis-sojja) (ara sezzjoni 4.4).
English: Placebo plus BSC (n=253)
Maltese: Plaċebo (N=255)
English: The incidence of Grade 3 hypertension was 8.7% (CRC), 28.0% (GIST) and 15.2% (HCC).
Maltese: L-inċidenza ta' pressjoni għolja ta' Grad 3 kienet ta' 8.7% (CRC), 28.0% (GIST) u 15.
English: Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Maltese: Peress li dejta limitata biss hija disponibbli għall-pazjenti b'indeboliment epatiku moderat (Child Pugh B), ma tistax tingħata rakkomandazzjoni ta' doża.
English: Metabolites may be reduced or hydrolysed in the gastrointestinal tract by microbial flora, allowing reabsorption of the unconjugated active substance and metabolites (enterohepatic circulation).
Maltese: Il-metaboliti jistgħu jitnaqqsu jew jiġu idrolizzati fl-apparat gastro-intestinali mill-flora mikrobika, li tippermetti assorbiment mill-ġdid tas-sustanza attiva u tal-metaboliti mhux konjugati (ċirkolazzjoni enteroepatika).
English: Inhibitors of P-glycoprotein and BCRP/Inducers of P-glycoprotein and BCRP In vitro studies indicate that the active metabolites M-2 and M-5 are substrates for P-glycoprotein and BCRP.
Maltese: Inibituri ta' glikoproteina P u BCRP/Indutturi ta' glikoproteina P u BCRP Studji in vitro jindikaw li l-metaboliti attivi