FrancophonIA/ELRC3.0 huggingface dataset:
English: • Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
Maltese: • Remettar u s-sogħla bid-demm, li jista' jkun aħmar ileqq jew jidher bħal kafe mitħun.
English: Efficacy with cabozantinib was observed in medullary thyroid cancer patients with wild-type or mutant RET.
Maltese: L-effikaċja b'cabozantinib ġiet osservata f'pazjenti b'kanċer fil-medulla tat-tirojdi b'RET wild-type jew mutanti.
English: 100 mg/day dose
Maltese: Doża ta' 100 mg/jum
English: Wound complications have been observed with cabozantinib.
Maltese: Ġew osservati komplikazzjonijiet tal-ġrieħi b'cabozantinib.
English: • Joint pain, muscle spasms
Maltese: • Uġigħ fil-ġogi, spażmi muskolari
English: Juvenile rats (comparable to a >2 year old pediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and bile duct hyperplasia.
Maltese: Firien ġovanili (komparabbli ma' popolazzjoni pedjatrika ta' > sentejn) li ngħataw cabozantinib urew żieda fil-parametri ta' ċelluli tad-demm bojod, tnaqqis fl-ematopojesi, sistema riproduttiva tal-mara pubixxenti/immatura (mingħajr dewmien fil-ftuħ tal-vaġina), abnormalitajiet fis-snien, kontenut u densità imnaqqsa ta' minerali fl-għadam, pugmentazzjoni fil-fwied u iperplasja fil-passaġġ biljari.
English: Renal and urinary disorders proteinuria, dysuria, haematuria renal failure acute
Maltese: Disturbi fil-kliewi u fis-sistema urinarja proteinurja, disurja, ematurja falliment tal-kliewi akut
English: Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
Maltese: Infezzjonijiet u Infestazzjonijiet axxess (li jinkludi vixxerali, ġilda, snien), pnewmonja, follikulite, infezzjoni bil-moffa (li tinkludi ġilda, orali, ġenitali)
English: Figure 1: Kaplan Meier curve of progression free survival
Maltese: Figura 1: Kurva ta' Kaplan-Maier għal sopravivenza mingħajr progressjoni
English: Black iron oxide (E172) (20 mg capsules only) Red iron oxide (E172) (80 mg capsules only) Titanium dioxide (E171)
Maltese: Red iron oxide (E172) (kapsuli ta' 80 mg biss)
English: Because oral contraceptives might possibly not be considered as “effective methods of contraception,” they should be used together with another method, such as a barrier method (see section 4.5).
Maltese: Peress li kontraċettivi orali jistgħu possibbilment ma jkunux kkonsidrati bħala “metodi effettivi ta' kontraċezzjoni” għandhom jintużaw flimkien ma' metodu ieħor, bħal metodu ta' barriera (ara sezzjoni
English: In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
Maltese: Fi studji ta' tossiċità b'dożi ripetuti fil-far u fil-kelb li damu sejrin għal sa 6 xhur, organi bersalljati għat-tossiċità kienu l-passaġġ GI, mudullun, tessuti limfojdi, il-kliewi, tessuti adrenali u tal-passaġġ riproduttiv.
English: 140 mg/day dose
Maltese: Doża ta' 140 mg/jum
English: The COMETRIQ 20 mg capsules contain cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Maltese: Il-kapsuli f'COMETRIQ 20 mg fihom cabozantinab (S)-malate ekwivalenti għal 20 mg cabozantinib.
English: Each 28 day pack contains enough medicine for 28 days.
Maltese: Kull pakkett ta' 28 jum fih biżżejjed mediċina għal 28 jum.
English: Sverige/Ruotsi/Svíþjóð Tlf/Puh/Tel/Sími: +46 8 451 60 00 Deutschland, Österreich
Maltese: +46 8 451 60 00 Deutschland, Österreich
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply).
Maltese: 21 x 20 mg kapsuli u 7 x 80 mg kapsuli (doża ta' 140 mg/jum għal 7 ijiem).
English: An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in cancer patients.
Maltese: Kienet osservata żieda fil-linja bażi tal-intervall ta' QT ikkorreġut minn Friderica (QTcF) ta' 10 - 15 ms fil-Jum 29 (imma mhux fil-Jum 1) wara li cabozantinib beda jingħata bħala trattament (f'doża ta' 140 mg qd) fi studju kliniku b'kontrolli f'pazjenti bil-kanċer.
English: Do not use this medicine after the expiry date which is stated on the blister card after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja tal-kartuna wara EXP.
English: Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmarplantar erythrodysaesthesia syndrome (PPES), and gastrointestinal (GI) events (abdominal or mouth pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Maltese: Każijiet li ġeneralment jseħħu b'mod bikri jinkludu ipokalċemija, ipokalemija, tromoċitopenija, pressjoni għolja, sindromu ta' eritrodisestesija palmar-plantar (PPES - palmar-plantar erythrodysaesthesia syndrome), u każijiet gastrointestinali (GI) (uġigħ fl-addome u fil-ħalq, infjammazzjoni mukożali, stitikezza, dijarea, remettar).
English: COMETRIQ 20 mg hard capsules
Maltese: COMETRIQ 20 mg kapsuli ibsin
English: 7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).
Maltese: 7 x 20 mg kapsuli u 7 x 80 mg kapsuli (doża ta' 100 mg/jum għal 7 ijiem).
English: Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Maltese: Għalhekk, it-teħid flimkien ta' impedituri qawwija ta' CYP3A4 (eż., ritonavir, itraconazole, erythromycin, clarithromycin,meraq tal-grejpfrut) ma' cabozantinub għandu jsir b'reqqa.
English: How to store COMETRIQ
Maltese: X'fih COMETRIQ
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti b'komplikazzjonijiet fil-fejqan ta' ġrieħi li jeħtieġu intervent mediku.
English: COMETRIQ 80 mg hard capsules
Maltese: COMETRIQ 80 mg kapsuli ibsin
English: All three subgroups showed increased PFS in the cabozantinib arm compared to the placebo arm (HRs of 0.23, 0.53, and 0.30 for RET mutation positive, negative, and unknown subgroups, respectively).
Maltese: It-tliet sottogruppi wrew żieda filPFS fil-grupp ta' cabozantinib meta mqabbel mal-grupp tal-plaċebo (HRs ta' 0.23, 0.53 u 0.30 għal mutazzjoni pożittiva, negattiva jew mhux magħrufa tas-sottogruppi ta' RET.
English: Results from a study in patients with hepatic impairment indicate that exposure (AUC0-inf) increased by 81% and 63% in subjects with mild and moderate hepatic impairment, respectively (90% CI for AUC0-inf: 121.44% to 270.34% for mild and 107.37% to 246.67% for moderate).
Maltese: Riżultat minn studju fuq pazjenti b'indeboliment tal-fwied jindika li l-esponiment (AUC0-inf) żdied b'81% u 63% f'individwi b'indeboliment tal-fwied ħafif għal moderat rispettivament (90% CI għal AUC0-inf: 121.44% sa 270.
English: The most frequent adverse reactions of any grade (experienced by at least 20% of patients) included diarrhoea, PPES, weight decreased, decreased appetite, nausea, fatigue, dysgeusia, hair colour changes, hypertension, stomatitis, constipation, vomiting, mucosal inflammation, asthenia, and dysphonia.
Maltese: L-aktar reazzjonijiet avversi frekwenti ta' kwalunkwe grad (esperjenzati f'tal-anqas 20% talpazjenti) kienu jinkludu dijarea, PPES, tnaqqis fil-piż, tnaqqis fl-aptit, tqalligħ, għeja, disgewsja, bidliet fil-kulur tax-xahar, pressjoni għolja, stomatite, stitikezza, remettar, infjammazzjoni mukosali, astenja, u disfonja.
English: Investigations weight decreased, serum ALT, AST, and ALP increased, blood LDH increased, blood TSH increased, lymphopenia, neutropenia, thrombocytopenia blood creatinine phosphokinase increased activated partial thromboplastin time shortened, eosinophil count increased, platelet count increased
Maltese: Investigazzjonijiet tnaqqis fil-piż, żieda fl-ALT, AST u ALP fis-serum, żieda fl-LDH fiddemm, żieda fitTSH fid-demm, limfopenja, newtropenja, tromboċitopenija creatinine phosphokinase fid-demm ogħla activitated partial thromboplastin time mqassar, żieda flgħadd ta' eosinofili, żieda fl-għadd ta' pjastrini
English: 21 x 20 mg capsules (60 mg/day dose for a 7-day supply).
Maltese: 21 x 20 mg kapsula (doża ta' 60 mg/jum għal 7 ijiem).
English: The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension.
Maltese: L-aktar reazzjonijiet avversi serji komuni assoċjati ma' cabozantinib huma pnewmonja, infjammazzjoni mukożali, ipokalċemija, disfaġja, deidrazzjoni, emboliżmu pulmonari u pressjoni għolja.
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Maltese: L-għoti fl-istess waqt ta' impeditur tal-proton-pump (proton pump inhibitor, PPI) esomeprazole (40 mg kuljum għal 6 ijiem) b'doża waħda ta' 100 mg cabozantinib lil voluntiera b'saħħithom ma rriżultax f'effett klinikament sinifikanti fl-esponiment ta' cabozantinib fil-plażma (AUC).
English: • Atrial fibrillation (a fast and erratic heartbeat)
Maltese: • Fibrilazzjoni atrijali (qalb tħabbat bil-qawwa jew b'mod erratiku)
English: Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti li jiżviluppaw infart mijokardjali akut jew kull komplikazzjoni tromboembolitika arterjali oħra klinikament sinifikanti.
English: • Blurred vision
Maltese: • Smigħ indebolit
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/890/002
English: The COMETRIQ 80 mg capsules contain cabozantinib (S)-malate equivalent to 80 mg of cabozantinib.
Maltese: Il-kapsuli f'COMETRIQ 80 mg fihom cabozantinab (S)-malate ekwivalenti għal 80 mg ta' cabozantinib.
English: 100 mg Dose
Maltese: Doża ta' 100 mg
English: Number of subjects at risk Month
Maltese: Numru ta' individwi f'riskju
English: Results from a study in patients with renal impairment indicate that the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment, compared to subjects with normal renal function.
Maltese: Riżultati minn studju fuq pazjenti b'indeboliment tal-kliewi jindikaw li l-proporzjonijiet ta' medji LS ġeometriċi għal cabozantinib fil-plażma, Cmax u AUC0-inf kienu 19% u 30% ogħla, għal individwi b'indeboliment tal-kliewi ħafif (90% CI għal Cmax 91.60% sa 155.
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Maltese: cabozantinib f'voluntiera b'saħħithom, madwar 81% tar-radjuattività mogħtija kienet irkuprata b'54% fl-ippurgar u 27% fl-awrina.
English: A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Maltese: Ikla b'ħafna xaħam żiedet moderatament il-valuri Cmax u l-AUC (41% u 57%, rispettivament) meta mqabbel ma' kundizzjonijiet ta' sawm f'voluntiera b'saħħithom li ngħataw doża orali waħda ta' 140 mg cabozantinib.
English: Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux COMETRIQ - jekk inti allerġiku għal cabozantinib jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Reversible posterior leukoencephalopathy syndrome
Maltese: Disturbi fis-sistema endokrinarja ipotajrojdiżmu
English: Metabolism and nutrition disorders decreased appetite, hypocalcaemia, hypophosphataemia, hyperbilirubinemia, hypokalaemia, hypomagnesaemia dehydration, hypoalbuminaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni tnaqqis fl-aptit, ipokalċemija, ipofosfatemija, iperbilirubinemija, ipokalimja, ipomanjesemija deidrazzjoni, ipoalbumenija
English: CEA Responsea
Maltese: MANIFATTUR RESPONSABBLI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/890/001
English: 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
Maltese: 7 x 20 mg u 7 x 80 mg kapsuli (100 mg/jum doża għal forniment ta' 7 ijiem) 21 x 20 mg u 7 x 80 mg kapsuli (140 mg/jum doża għal forniment ta' 7 ijiem) Pakkett ta' 28 jum li fih:
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Maltese: Fil-firien, cabozantinib ikkaġuna telf wara l-impjantazzjoni, edema fetali, palat/xoffa maqsuma, aplasja dermali u denb mgħawweġ jew rudimentari.
English: What you need to know before you take COMETRIQ 3.
Maltese: X'għandek tkun taf qabel ma tieħu COMETRIQ 3.
English: Nervous system disorders dysgeusia, headache, dizziness cerebrovascular accident, peripheral neuropathy, paraesthesia, ageusia, tremor ataxia, disturbance in attention, hepatic encephalopathy, loss of consciousness, speech disorder, posterior reversible encephalopathy syndrome
Maltese: Disturbi fis-sistema nervuża disgewsja, uġigħ ta' ras, stordament inċident ċerebrovaskulari, newropatija periferali, paraestesija, agewsja, rogħda atassja, disturb fl-attenzjoni, enċefalopatija eparika, nuqqas ta' koxjenza, disturb fid-diskors, sindromu ta' enċefalopatija riversibbli posterjuri
English: Results from a study in patients with renal impairment indicate that the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function.
Maltese: 26%) u 2% u 6-7% ogħla (90% CI għal Cmax 78.64% sa 133.52%; AUC0-inf 79.61% sa 140.
English: 60 mg/day dose
Maltese: Doża ta' 60 mg/jum
English: - Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin, and rifampicin - Allergy medicines such as fexofenadine and ranolazine - Steroids used to reduce inflammation or treat a number of different diseases of the immune system - Medicines used to treat epilepsy or fits such as phenytoin, carbamazepine, and phenobarbital - Herbal preparations containing St. John's Wort (Hypericum perforatum), sometimes used for treating depression or depression-related conditions such as anxiety - Medicines used to thin the blood, such as warfarin - Medicines to treat high blood pressure or other heart conditions, such as aliskiren, ambrisentan,
Maltese: clarithromycin u rifampicin - Mediċini tal-allerġija bħal fexofenadine u ranolazine - Sterojdi użati biex inaqqsu l-infjammazzjoni jew biex jikkuraw għadd differenti ta' mard marbut mas-sistema immuni - Mediċini użati għall-kura ta' epilessija jew ħmar il-lejl bħal phenytoin, carbamazepine u phenobarbital - Preparazzjonijiet bi ħxejjex li jkun fihom St John's Wort (Hypericum perforatum), li xi kultant jintuża biex jikkura d-depressjoni jew kondizzjonijiet marbuta mad-depressjoni bħal ansjetà - Mediċini użati biex iraqqu d-demm, bħal warfarina - Mediċini użati fil-kura tal-pressjoni għolja tad-demm jew kondizzjonijiet oħra tal-qalb, bħal aliskiren, ambrisentan, dabigatran etexilate, digoxin, talinolol u tolvaptan - Mediċini użati għad-dijabete, bħal saxagliptin u sitagliptin - Mediċini użati għall-kura ta' gotta, bħal colchicine - Mediċini użati biex jikkuraw HIV jew AIDS, bħal ritonavir, maraviroc u emtricitabine - Mediċini użati għall-kura ta' infezzjonijiet virali bħal efavirenz - Mediċini użati biex jipprevjenu r-riġetazzjoni ta' trapjanti (cyclosporine) i programmi ta'
English: Proteinuria has been observed with cabozantinib.
Maltese: L-emorraġija ġiet osservata b'cabozantinib.
English: • Chills, tremors
Maltese: • Sirdat, rogħda
English: Tel: +372 60 15 540 Ελλάδα, Κύπρος, Malta
Maltese: Tel: +372 60 15 540
English: Pack for the 60 mg daily dose 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) Each 60 mg daily dose contains three grey 20 mg capsules.
Maltese: Pakkett għad-doża ta' 60 mg ta' kuljum21 x 20 mg kapsuli (doża ta' 60 mg/jum għal 7 ijiem) Kull doża ta' 60 mg kuljum fiha tliet kapsuli griżi ta' 20 mg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/890/003
English: The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Maltese: Il-livell ta' effetti avversi mhux osservati (NOAEL - the no observed adverse effect level) għal dawn ir-riżultati kien inqas mil-livelli ta' esponiment kliniku uman fid-doża terapewtika maħsuba.
English: BLISTER CARD, 60 mg dose
Maltese: Pakkett għad-doża ta' 60 mg darba kuljum
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/890/005 56 kapsula (4 kartun b'folja ta' 7 x 20 mg u 7 x 80 mg) (doża ta' 100 mg/jum għal 28 jum)
English: Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Maltese: Studji fl-annimali wrew effetti embriju-fetali u teratoġeniċi (ara sezzjoni 5.3). Ir-riskju potenzjali għall-bniedem mhux magħruf.
English: How to take COMETRIQ 4.
Maltese: Kif għandek tieħu COMETRIQ 4.
English: Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Maltese: L-għoti ta' impedituri ta' MRP2 jista' jirriżulta f'żidiet fil-konċentrazzjonijiet ta' cabozantinib filplażma.
English: CYP3A4 inducers and inhibitors
Maltese: Sensibilizzaturi u impedituri ta' CYP3A4
English: 60 mg Dose
Maltese: Doża ta' 60 mg
English: What COMETRIQ looks like and contents of the pack COMETRIQ 20 mg capsules are grey and have “XL184 20mg” printed on one side.
Maltese: Il-kapsuli ta' COMETRIQ 20 mg huma griżi u għandhom "XL184 20mg" stampat fuq naħa minnhom.
English: Avoid becoming pregnant while being treated with COMETRIQ.
Maltese: Evita li tinqabad tqila waqt li qed tkun ikkurata b'COMETRIQ.
English: Therefore chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Maltese: Għalhekk, l-għoti kroniku ta' sustanzi li huma sensibilizzaturi qawwija ta' CYP3A4 ma' cabozantinib għandu jiġi evitat, (ara sezzjonijiet 4.2 u 4.5).
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Maltese: Tagħrif in vitro juri li cabozantinib huwa sottostrat ta' MRP2.
English: Hemorrhage has been observed with cabozantinib.
Maltese: Il-pressjoni għolja ġiet osservata b'cabozantinib.
English: PHARMACEUTICAL FORM AND CONTENTS 60 mg Dose 28 day pack: 84 capsules (4 blister cards of 21 x 20 mg capsules) for the 60 mg daily dose for a 28 day supply.
Maltese: U KONTENUT Doża ta' 60 mg Pakkett ta' 28 jum: 84 kapsula (kartun ta' 4 folji ta': 21 x 20 mg kapsula) għal doża ta' kuljum ta' 60 mg għal 28 jum.
English: Blister cards containing:
Maltese: Disturbi fil-fwied u fil-marrara:
English: Do not store above 25 ºC.
Maltese: Taħżinx f'temperatura 'l fuq minn 25ºC.
English: The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Maltese: Il-kapsuli ibsin huma oranġjo b' "XL184 80mg" stampat bl-iswed fil-korp tal-kapsula.
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Maltese: L-ebda aġġustament mhu indikat meta sustanzi li jimmodifikaw l-pH tal-istonku (jiġifieri PPIs, antagonisti riċettaturi ta' H2, u antaċidi) jingħataw flimkien ma' cabozantinib.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma bażati fuq il-gradi kollha u huma mfissra bħala komuni ħafna (≥1/10), komuni (≥1/100 sa 1/10), mhux komuni (≥1/1,000 sa 1/100); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule.
Maltese: Il-kapsuli ibsin huma griżi b' "XL184 20mg" stampat bl-iswed fil-korp tal-kapsula.
English: PHARMACEUTICAL FORM AND CONTENTS 140 mg Dose 28 day pack: 112 capsules (4 blister cards of 21 x 20 mg capsules and 7 x 80 mg capsules) for the 140 mg daily dose for a 28 day supply.
Maltese: Pakkett ta' 28 jum: 112-il kapsula (kartun ta' 4 folji ta': 21 x 20 mg kapsuli u 7 x 80 mg kapsuli) għal doża ta' kuljum ta' 140 mg għal 28 jum.
English: aspergilloma
Maltese: asperġilloma
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Maltese: Kapsula iebsa fiha cabozantinab (S)-malate ekwivalenti għal 20 mg cabozantinib.
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Maltese: 7 x 20 mg kapsuli u 7 x 80 mg kapsuli (doża ta' 100 mg/jum għal 7 ijiem) Kull doża ta' 100 mg kuljum, tikkonsisti f'kombinazzjoni ta' kapsula waħda griża ta' 20 mg u kapsula oranġjo ta' 80 mg.
English: Ear and labyrinth disorders ear pain, tinnitus hypoacusis
Maltese: Disturbi filwidnejn u fissistema labirintika uġigħ fil-widnejn, tinnite ipoakusi
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
Maltese: Kapsula iebsa fiha cabozantinab (S)-malate ekwivalenti għal 20 mg jew 80 mg cabozantinib.
English: • Swollen lymph glands
Maltese: • Infjammazzjoni tal-għajnejn, kataretti
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti li jiżviluppaw s-sindromu nefrotiku.
English: These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Maltese: Sindromu ta' lewkoenċefalopatija posterjuri riversibbli.
English: Hepatobiliary disorders cholelithiasis
Maltese: Tfal u adolexxenti
English: Pack for the 100 mg daily dose
Maltese: Pakkett għad-doża ta' 100 mg darba kuljum
English: If you take COMETRIQ whilst using oral contraceptives, the oral contraceptives may be ineffective.
Maltese: Jekk qed tieħu COMETRIQ waqt li qed tuża kontraċettivi orali, il-kontraċettivi orali jistgħu ma jkunux effettivi.
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, hair colour changes, rash, dry skin, alopecia, erythema hyperkeratosis, acne, blister, hair growth abnormal, skin exfolation, skin hypopigmentation skin ulcer, telangiectasia
Maltese: Disturbi fil-ġilda u fit-tessut ta' taħt ilġilda sindromu ta' eritrodisestesija palmar-plantar, bidliet fil-kulur tax-xagħar, raxx, ġilda xotta, alopeċja, eritema iperkeratosi, akne, infafet, xagħar jikber b'mod abnormali, tqaxxir tal-ġilda, ipopigmentazzjoni tal-ġilda ulċera fil-ġilda, telangijektasja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/004 84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply) 13.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/890/004 84 kapsula (4 kartun b'folja ta' 21 x 20 mg) (doża ta' 60 mg/jum għal 28 jum) 13.