FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions from clinical studies are presented using frequencies for all-causality adverse events.
Maltese: Reazzjonijiet avversi minn studji kliniċi huma ppreżentati bl-użu ta' frekwenzi għal avvenimenti avversi għal kull kawżalità.
English: Medicinal products for which intestinal absorption is restricted by BCRP Tivozanib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown (see section 5.2).
Maltese: Prodotti mediċinali li għalihom l-assorbiment intestinali huwa ristrett minn BCRP Tivozanib jinibixxi l- proteina trasportatur BCRP in vitro, iżda r-rilevanza klinika ta' din is-sejba mhix magħrufa (ara sezzjoni 5.2).
English: Pooled data of 674 patients with advanced RCC who continued to receive tivozanib as their initial on trial therapy in the five core RCC monotherapy studies have been evaluated in the overall assessment of safety and tolerability of tivozanib.
Maltese: Dejta miġbura ta' 674 pazjent b'RCC avvanzat li komplew jirċievu tivozanib terapija tagħhom fuq prova inizjali fil-ħames studji ewlenin tal-monoterapija ta' RCC ġew evalwati fil-valutazzjoni ġenerali ta' sikurezza u tollerabilità ta' tivozanib.
English: 20 Gingivitis including gingival bleeding, gingival disorder, gingival pain and gingivitis 21 Alanine aminotransferase (ALT) increased / Aspartate aminotransferase (AST) increased including ALT increased and AST increased
Maltese: 20 Ġinġivite inkluż fsada ġinġivali, disturb ġinġivali, uġigħ ġinġivali u ġinġivite 21 Żieda fl-alanine aminotransferase (ALT) / Żieda fl-aspartate aminotransferase (AST) inkluż żieda fl-ALT u żieda fl-AST
English: Contains tartrazine.
Maltese: TA' EĊĊIPJENTI Fih tartrazina.
English: In clinical studies with tivozanib, arterial thromboembolic events (ATEs) have occurred (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, seħħew avvenimenti tromboembolitiċi arterjali (ĦAD) (ara sezzjoni 4.8).
English: Venous thromboembolism11
Maltese: Tromboemboliżmu venuż11
English: Tivozanib potently and selectively blocks all 3 Vascular Endothelial Growth Factor receptors (VEGFR) and has been shown to block various VEGF-induced biochemical and biologic responses in vitro, including VEGF-ligand-induced phosphorylation of all three VEGFR 1, 2 and 3, and proliferation of human endothelial cells.
Maltese: Tivozanib jibblokka b'mod qawwi u selettiv it-tliet riċetturi tal-Fattur tat-Tkabbir tal-Endotelju Vaskulari (VEGFR) u wera li jimblokka varji risponsi bijokimiċi u bijoloġiċi indotti mill-VEGF in vitro, inklużi fosforilazzjoni indotta mill-VEGF-ligand tat-tliet VEGFR 1, 2 u 3, u l-proliferazzjoni taċ-ċelluli endoteljali umani.
English: Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 4.4 and section 5.2).
Maltese: Pazjenti b'indeboliment epatiku moderat għandhom jiġu kkurati biss b'tivozanib ta' 1340 mikrogramma kapsula waħda kull jumejn li jista' jkollhom riskju akbar ta' reazzjonijiet avversi minħabba l-espożizzjoni miżjuda bid-doża ta' 1340 mikrogramma kuljum (ara sezzjoni 4.4 u sezzjoni 5.2).
English: Posterior Reversible Encephalopathy Syndrome (PRES) PRES (also known as reversible posterior leukoencephalopathy syndrome (RPLS)) was confirmed in one non-RCC patient after approximately 8 weeks on tivozanib.
Maltese: Sindromu tal-enċefalopatija riversibbli posterjuri (PRES) PRES (magħruf wkoll bħala sindromu tal-lewkoenċefalopatija riversibbli posterjuri (RPLS)) kien ikkonfermat f'pazjent wieħed mhux RCC wara madwar 8 ġimgħat fuq tivozanib.
English: Swallow the capsule whole.
Maltese: Ibla l-kapsula sħiħa.
English: Fotivda 890 microgram hard capsules tivozanib
Maltese: Fotivda 890 mikrogramma kapsuli iebsin tivozanib
English: AST, ALT, bilirubin, and AP should be monitored before initiation of and periodically throughout treatment with tivozanib because of the potential risk of hepatotoxicity (see section 4.2).
Maltese: AST, ALT, bilirubin, u AP għandhom jiġu mmonitorjati qabel ma jinbeda u perjodikament matul il-kura b'tivozanib minħabba r-riskju potenzjali ta' tossiċità fil-fwied (ara sezzjoni 4.2).
English: Furthermore, tivozanib was not an in vitro inhibitor of OAT1, OAT3, OCT2, MATE1 and MATE2-K or substrate of MRP2 and BCRP.
Maltese: Barra minn hekk, tivozanib ma kienx inibitur in vitro ta' OAT1, OAT3, OCT2, MATE1 u MATE2-K jew substrat ta' MRP2 u BCRP.
English: Elderly patients No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).
Maltese: Pazjenti anzjani L-ebda aġġustament fid-doża m'hu meħtieġ f'pazjenti ta' 65 sena jew akbar (ara sezzjonijiet 4.4 u 5.1).
English: Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram tivozanib.
Maltese: Kull kapsula iebsa fiha tivozanib idrokloridu monoidrat ekwivalenti għal 1340 mikrogramma tivozanib.
English: Magnesium stearate
Maltese: Stearat tal-manjeżju
English: • if laboratory tests show that there is protein in your urine Your doctor will monitor this at the beginning and during your treatment.
Maltese: • jekk it-testijiet tal-laboratorju juru li hemm proteina fl-awrina tiegħek It-tabib tiegħek ser jimmonitorja dan fil-bidu u waqt it-trattament tiegħek.
English: In clinical studies with tivozanib, hypertension (including persistent severe hypertension) has occurred (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, pressjoni għolja (inklużi pressjoni għolja severa persistenti) kienet osservata (ara sezzjoni 4.8).
English: d Hazard ratio for tivozanib arm vs. sorafenib arm subgroup analyses, based on unstratified Cox proportional hazards model.
Maltese: e Valur p nominali għal analiżi ta' sottogrupp bbażat fuq it-test ta' log rank mhux stratifikat.
English: 22 Erythema including erythema, generalised erythema and palmar erythema 23 Pruritus including generalised pruritus and pruritus
Maltese: 22 Eritema inkluż eritema, eritema ġeneralizzata u eritema palmari 23 Prurite inkluż prurite ġeneralizzata u prurite
English: • Memory loss.
Maltese: • Telf tal-memorja.
English: Hypothyroidism was reported as an adverse reaction for 5.6% of patients during initial therapy and was CTC Grade 2 or lower in all cases.
Maltese: Ġiet irrappurtat ipotiroidiżmu bħala reazzjoni avversa f'5.6% f'pazjenti waqt terapipija inizjali u kien CTC Grad 2 jew iktar baxx fil-każijiet kolla.
English: Each capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram of tivozanib.
Maltese: Kull kapsula fiha monoidrat idrokloridu tivozanib ekwivalenti għal 1340 mikrogramma ta' tivozanib.
English: Management of patients experiencing HFSR may include topical therapies for symptomatic relief with consideration of temporary interruption and/or reduction in treatment dose or, in severe or persistent cases, permanent discontinuation of treatment.
Maltese: L-immaniġġjar ta' pazjenti li jġarrbu HFSR jistgħu jinkludu terapiji topiċi għal serħan sintomatiku b'konsiderazzjoni ta' interruzzjoni temporanja u/jew it-tnaqqis fid-doża tat-trattament jew, f'każijiet serji jew persistenti, it-twaqqif permanenti tat-trattament.
English: Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Maltese: Fotivda huwa indikat għal kura għall-ewwel darba f' pazjenti adulti b'karċinoma avvanzata taċ-ċelluli renali (RCC) u għal pazjenti adulti li huma neqsin mis-sistema tal-inibitur VEGFR u mTOR wara l-progressjoni tal-marda wara trattament wieħed minn qabel bit-terapija ta' ċitokina għal RCC avvanzata.
English: The most frequent adverse reactions leading to tivozanib dose reduction/ interruption were hypertension (4.7%), diarrhoea (3.1%), fatigue
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti li jwasslu għal tnaqqis/interruzzjoni tad-doża ta' tivozanib kienu ipertensjoni (4.7%), dijarea (3.1%), għeja (1.8%).
English: Risk factors for hypothyroidism include prior history of hypothyroidism and use of anti-thyroid medications.
Maltese: Fatturi ta' riskju għal ipotirojdiżmu jinkludu storja preċedenti ta' ipotirojdiżmu u l-użu ta' mediċini antitirojde.
English: Tivozanib has not been studied in patients who had a VTE within the preceding 6 months of clinical study initiation.
Maltese: Tivozanib ma ġiex studjat f'pazjenti li kellhom ATE fis-6 xhur qabel il-bidu studju kliniku.
English: ALT increased / AST increased21
Maltese: Uġigħ addominali15
English: Pulmonary oedema was reported in two patients (0.3%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies.
Maltese: Ġiet irrappurtata edima pulmonari f'żewġ pazjenti (0.3%) li rċevew tivozanib bħala terapija inizjali fil-ħames studji ewlenin tal-monoterapija ta' RCC.
English: Increased testis weights were observed at a dose 7-fold higher than the recommended clinical dose.
Maltese: Żieda fil-piżijiet testikoli kienu osservati f'doża 7 darbiet ogħla mid-doża klinika rakkomandata.
English: In nonclinical studies assessing mating and fertility parameters in male rats, doses > 2-fold higher than the recommended clinical dose, produced increased epididymis and testis weights associated with infertility.
Maltese: Fi studji mhux kliniċi li jevalwaw parametri ta' tgħammir u fertilità fil-firien maskili, dożi > 2 darbiet ogħla mid-doża klinika rakkomandata, ipproduċew epididimis miżjuda u piżijiet tat-testikoli assoċjati ma' infertilità.
English: Hyperhidrosis Xeroderma
Maltese: Tromboemboliżmu venuż
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows.
Maltese: Ma ġewx osservati effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' espożizzjoni simili għall-livelli ta' espożizzjoni kliniċi u b'rilevanza possibbli għall-użu kliniku kienet kif ġej:
English: If any bleeding requires medical intervention, tivozanib should be temporarily interrupted.
Maltese: Jekk fsada teħtieġ intervent mediku, tivozanib għandu jitwaqqaf temporanjament.
English: The recommended dose is one Fotivda 1340 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken.
Maltese: Id-doża rakkomandata hija kapsula waħda Fotivda 1340 mikrogrammi, li tittieħed darba kuljum għal 21 jum (3 ġimgħat), segwita minn perjodu ta' 7 ijiem (ġimgħa) meta ma jittieħdux kapsuli.
English: Animal studies indicate that male and female fertility may be affected by treatment with tivozanib (see section 5.3).
Maltese: Studji fl-annimali jindikaw li fertilità fl-irġiel u nisa jistgħu jkunu affettwati permezz ta' trattament b'tivozanib (ara sezzjoni 5.3).
English: Based on the population pharmacokinetic analysis, there is no clinically relevant effect of age, gender or race on the pharmacokinetics of tivozanib.
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni, m'hemmx effett rilevanti klinikament ta' età, sess jew razza fuq il-farmakokinetika ta' tivozanib.
English: In clinical studies with tivozanib, hypothyroidism has been reported (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, ġie rrappurtat ipotirojdiżmu (ara sezzjoni 4.8).
English: • Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stomach; swollen and painful tongue; inflamed painful and/or bleeding gums.
Maltese: • Ġilda ħamra, minfuħa u muġugħa; infafet tal-ġilda; għaraq eċċessiv; urtikarja.
English: • Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
Maltese: • Sturdament; tisfir fil-widnejn; sturdament u sensazzjoni ta' dawran b'ħeffa kbira (vertigo).
English: • if you have problems with your liver.
Maltese: • jekk għandek problemi bil-fwied tiegħek.
English: It is currently unknown whether tivozanib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method (see section 4.6).
Maltese: Għadu mhux magħruf jekk tivozanib jistax inaqqas l-effettività ta' kontraċettivi ormonali, u għalhekk nisa li jużaw kontraċettivi ormonali għandhom iżidu metodu ta' kontraċezzjoni mekkanika (ara sezzjoni 4.6).
English: In repeat-dose toxicity studies in rats, abnormalities were noted in growing incisors (thin brittle teeth, tooth loss, malocclusions) at doses approximately 2-fold greater than the calculated human equivalent dose and growth plate hypertrophy was observed at doses approximately 0.7- to 7-fold greater than the calculated human equivalent dose.
Maltese: Fi studji ta' tossiċità minn dożi ripetuti fil-firien, anormalitajiet kienu nnotati fl-inċiżuri (snien fraġli irqiq, telf tas-snien, malokklużjoniet) b'dożi madwar żewġ darbiet aktar mid-doża ekwivalenti umana kkalkulata u ipertrofija tas-saffi tal-iżvilupp kienet osservata f'dożi ta' madwar 0.7-7 darbiet akbar mid-doża ekwivalenti tal-bniedem kkalkulata.
English: Deep vein thrombosis was also reported in two patients (0.3%) and was CTC Grade ≥ 3 in one patient (0.1%) receiving initial tivozanib therapy.
Maltese: Grad ≥ 3 f'pazjent wieħed (0.1%) li rċieva terapija inizjali b'tivozanib.
English: Adverse reactions occurring in patients who continued to receive tivozanib as their initial on trial therapy in the five RCC monotherapy studies were pooled and are listed below by MedDRA body system organ class (SOC) and frequency.
Maltese: Reazzjonijiet avversi li seħħew f'pazjenti li komplew jirċievu tivozanib bħala terapija tagħhom fuq prova inizjali fil-ħames studji ewlenin tal-monoterapija RCC kienu miġbura u huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi tal-ġisem MedDRA (SOC) u l-frekwenza.
English: Patients taking an oral BCRP substrate with a clinically-relevant efflux interaction in the gut should ensure that a suitable time window (e.g. 2 hours) is applied between administration of tivozanib and the BCRP substrate.
Maltese: Pazjenti li qed jieħdu sottostrat BCRP orali b'interazzjoni ta' effluss klinikament-rilevanti fil-musrana għandhom jiżguraw li perjodu taż-żmien xieraq (eż sagħtejn) jiġi applikat bejn l-amministrazzjoni tat-tivozanib u s-sottostrat BCRP.
English: • Tiredness; unusual weakness; pain (including in the mouth, bone, extremities, side of the body,
Maltese: • Għeja; dgħjufija mhux tas-soltu; uġigħ (inkluż fil-ħalq, għadam, estremitajiet, ġenb tal-ġisem,
English: • if you have symptoms of gastrointestinal perforation or fistula formation (developing a hole in the stomach or intestine or abnormal passages forming between parts of the intestine) such as severe stomach pain, chills, fever, nausea, vomiting or painful bowel obstruction, diarrhoea or rectal bleeding.
Maltese: • jekk għandek sintomi ta' perforazzjoni gastrointestinali jew formazzjoni ta' fistula (l-iżviluppar ta' toqba fl-istonku jew fil-musrana jew fil-passaġġi anormali li jiffurmaw bejn partijiet tal-musrana) bħal uġigħ qawwi fl-istonku, sirdat, deni, dardir, rimettar jew ostruzzjoni fl-imsaren bl-uġigħ, dijarea jew fsada rettali.
English: Tivozanib was shown to be teratogenic, embryotoxic and foetotoxic in pregnant rats at dose levels 5 times lower than the recommended clinical dose (based on a 60 kg human).
Maltese: Tivozanib wera' li huwa teratoġeniku, embrijotossiku u fetutossiku fil-firien tqal f'livelli ta' dożi 5 darbiet inqas mid-doża klinika rakkomandata (ibbażati fuq bniedem ta' 60 kg).
English: In clinical studies with tivozanib as monotherapy for the treatment of patients with RCC, cardiac failure has been reported (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib bħala monoterapija għall-kura ta'pazjenti b'RCC, insuffiċjenza kardijaka ġiet irrapportata (ara sezzjoni 4.8).
English: Epistaxis Rhinorrhoea Nasal congestion
Maltese: Sindromu tal-enċefalopatija riversibbli posterjuri
English: Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 5.2).
Maltese: Pazjenti b'indeboliment epatiku moderat għandhom jiġu ttrattati biss b'tivozanib kapsula waħda ta' 1340 mikrogramma kull jumejn minħabba li jista' jkollhom riskju akbar ta' reazzjonijiet avversi minħabba l-espożizzjoni miżjuda bid-doża ta' 1340 mikrogramma kuljum (ara sezzjoni 5.2).
English: Transient ischaemic attack Memory impairment4
Maltese: .8 Effetti mhux mixtieqa
English: reduced vision, or changes in your mental state) o a stroke, or signs and symptoms of a ‘mini-stroke' (transient ischaemic attack) o a heart attack o high blood pressure o diabetes o major surgery o multiple injuries such as broken bones and damage to internal organs o inability to move for a long period o heart failure which can cause shortness of breath or ankle swelling o inability to breathe, bluish colour on your skin, fingertips or lips, restlessness, anxiety,
Maltese: o attakk tal-qalb o pressjoni għolja tad-demm o dijabete o kirurġija maġġuri o korrimenti multipli bħal għadam miksur u ħsara lill-organi interni o inabbiltà li tiċċaqlaq għal perjodu twil o insuffiċjenza tal-qalb li jista' jikkawża qtugħ ta' nifs jew nefħa fl-għaksa o inabbiltà li tieħu n-nifs, kulur blu fuq il-ġilda tiegħek, ponot ta' swaba tiegħek jew xufftejk, tħossok bla sabar, ansjetà, konfużjoni, bidla fis-sensi jew sens ta' għarfien,
English: The clinical effects of strong CYP3A4 inducers on repeated daily dosing of tivozanib has not been studied but potentially the average time to reach steady-state and the average steady-state serum concentration of tivozanib may be reduced, due to the reduction in half-life.
Maltese: L-effetti kliniċi ta' indutturi qawwija ta' CYP3A4 fuq dożaġġ ripetut ta' kuljum ta' tivozanib ma ġewx studjata iżda potenzjalment l-ħin medju biex jilħqu stat stabbli u l-konċentrazzjoni medja fis-serum fi stat fiss ta' tivozanib jista' jitnaqqas, minħabba t-tnaqqis fin-nofs ħajja.
English: When dose reduction is necessary, the tivozanib dose can be reduced to 890 microgram once daily with the normal treatment schedule of 21 days of dosing, followed by a 7-day rest period.
Maltese: Meta tnaqqis fid-doża hija meħtieġa, id-doża ta' tivozanib tista' titnaqqas għal 890 mikrogramma darba kuljum bl-iskeda ta' trattament normali ta' 21 jum ta' dożaġġ, segwit minn perjodu ta' mistrieħ ta' 7 ijiem.
English: Fotivda 890 microgram
Maltese: Fotivda 890 mikrogramma kapsuli iebsin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Maltese: Akne inkluż akne u dermatite akneiforma
English: No capsules are taken
Maltese: Qoxra tal-kapsula
English: PRES is a neurological disorder that may present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Maltese: PRES huwa disturb newroloġiku li jista' jkun ippreżentat flimkien ma' uġigħ ta' ras, attakk ta' puplesija, letarġija, konfużjoni, għama u disturbi fil-vista u newroloġiċi oħrajn.
English: Capsule shell Gelatin
Maltese: Ma jittieħdux kapsuli
English: • Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals,
Maltese: • Fsada, eż fil-moħħ, mill-ħalq, ħanek, pulmuni, fl-istonku, ulċeri fl-imsaren, ġenitali femminili, anus, glandola adrenali.
English: Hypothyroidism
Maltese: Iperidrosi
English: • Diarrhoea
Maltese: • Dijarrea.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Maltese: Sintomi jinkludu uġigħ ta' ras, attakk ta' puplesija, nuqqas ta' enerġija, konfużjoni, għama jew disturbi fil-vista u newroloġiċi oħra.
English: The study included patients who had all undergone prior nephrectomy, and who had received either no prior therapy or no more than one prior systemic therapy in the metastatic setting (immunotherapy/chemotherapy); prior treatment with VEGF or mechanistic Target of Rapamycin (mTOR) targeted therapy was not allowed.
Maltese: L-istudju kien jinkludi pazjenti li kienu kollha li qabel kienu għamlu nefrektomija, u li kienu rċevew jew l-ebda terapija minn qabel jew mhux inqas minn terapija sistemika waħda fl-issettjar metastatiku (immunoterapija/kimoterapija); trattament minn qabel ma' VEGF jew terapija immirata lejn Mira mekkanistika ta' Rapamycin (mTOR) ma kienx permess.
English: Pregnancy
Maltese: Xeroderma
English: Unchanged tivozanib is the major circulating form of the molecule, and there were no major metabolites detected in serum at exposure equal to or greater than 10% of the total radioactivity exposure.
Maltese: Tivozanib mhux mibdul huwa l-aktar forma tal-molekula li jiċċirkola, u ma kienx hemm metaboliti maġġuri misjuba fis-serum fl-esponiment daqs jew akbar minn 10% tal-esponiment totali radjuattività.
English: • Hand-foot-syndrome with skin reddening, swelling, numbness and skin peeling on palms and soles.
Maltese: • Sindromu tal-idejn u s-saqajn bi ħmura tal-ġilda, nefħa, tnemnim u tqaxxir tal-ġilda fuq pali u l-qiegħ.
English: c p-value based on stratified Cochran-Mantel-Haenszel (CMH) statistic.
Maltese: • Jekk qed tiġi kkurat għal rata u ritmu anormali ta' taħbit tal-qalb (arritmija).
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100 persuna)
English: • Both you and your partner must use effective contraception.
Maltese: • Kemm inti u s-sieħeb tiegħek għandkom tużaw kontraċezzjoni effettiva.
English: - Printing ink, yellow: shellac, propylene glycol, strong ammonia solution, titanium dioxide
Maltese: - Linka tal-istampar, isfar: shellac, glikol tal-propylene, soluzzjoni qawwija tal-ammonju,
English: • Talk to your doctor when planning a baby, as Fotivda may affect the fertility of men and women.
Maltese: • Kellem lit-tabib tiegħek meta tippjana tarbija, peress li Fotivda jista' jaffettwa l-fertilità tal-irġiel u n-nisa.
English: Coronary artery insufficiency
Maltese: Insuffiċjenza talarterji koronarji
English: Tivozanib was shown to cause growth plate hypertrophy, absence of active corpora lutea and no maturing follicles in cynomolgus monkeys at dose levels that produced exposures equivalent to those seen at the recommended clinical dose.
Maltese: Tivozanib wera' li jikkawża ipertrofija tas-saffi tal-iżvilupp, nuqqas ta' corpora lutea attiva, u nuqqas ta' follikuli li jkunu qed jimmaturaw f'xadini ċinomolgi f'livelli ta' doża li produċew espożizzjonijiet ekwivalenti għal dawk li dehru fid-doża klinika rakkomandata.
English: Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favour of tivozanib; b p-value based on stratified log-rank test. Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2);
Maltese: Fatturi ta' stratifikazzjoni huma numru ta' trattamenti minn qabel (0 jew 1) u numru ta' siti metastatiċi/organi involuti (1 jew ≥2); c Valur p nominali bbażat fuq statistika Cochran-Mantel Haenszel (CMH) stratifikata.
English: • Paleness and tiredness from excess bleeding.
Maltese: • Diffikultà biex titkellem.
English: High blood pressure is the most serious and a very common side effect (see also in section 2 “Warnings and Precautions”).
Maltese: Pressjoni tad-demm għolja hija l-aktar effett sekondarju sekondarju u komuni ħafna (ara wkoll f'sezzjoni 2 "Twissijiet u prekawzjonijiet").
English: Pulmonary embolism was reported in patients (0.7%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies, with the majority CTC Grade ≥ 3 (see section 4.4).
Maltese: Ġiet irrappurtata emboliżmu pulmonari fil-pazjenti (0.7%) li rċieva tivozanib bħala terapija inizjali fil-ħames studji ewlenin tal-monoterapija ta' RCC, bil-maġġoranza CTC
English: Hard capsule with dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body.
Maltese: Kapsula iebsa b'tapp opak blu skur u korp opak isfar jgħajjat, stampat b'linka safra “TIVZ” fuq it-tapp u b'linka blu skura “LD” fuq il-korp.