FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ligament rupture, in line with a review provide by the MAH in which possible causal relationship in some cases without alternative explanations in combination with biological plausibility were identified.
Maltese: • Ftuq ta' ligament, b'konformità ma' analiżi pprovduta mill-MAH li fiha ġiet identifikata relazzjoni kawżali possibbli f'ċerti każijiet mingħajr spjegazzjonijiet alternattivi f'taħlita ma' plawżibbiltà bijoloġika.
English: However, most MRSA isolates are resistant to levofloxacin.
Maltese: Madankollu, ħafna milliżolati tal-MRSA huma reżistenti għal levofloxacin.
English: With regards the contra indication in patients with glucose-6phosphate dehydrogenase (G6PD) deficiency it was agreed to keep this relative contra indication in the warning section of the SmPC as it was approved in all but one MS.
Maltese: Fir-rigward tal-kontra-indikazzjoni f'pazjenti b'defiċjenza ta' glucose-6-phosphate dehydrogenase (G6PD), sar qbil sabiex din din il-kontro-indikazzjoni relattiva tinżamm fis-sezzjoni tat-twissijiet tal-SmPC hekk kif kienet approvata fl-SM kollha minbarra wieħed.
English: Furthermore, the wording is misleading as it implies that standard treatment is monotherapy.
Maltese: Barra minn hekk, it-test huwa qarrieqi peress li jimplika li t-trattament standard huwa monoterapija.
English: The warning under sub-heading “Interference with laboratory tests” was updated mainly to include sentence on M. tuberculosis, which is considered class labelling and which is included in the Company Core Data Sheet (CCDS).
Maltese: It-twissija taħt is-sottointestatura “Interferenza ma' testijiet tal-laboratorju” ġiet aġġornata l-aktar sabiex tinkludi sentenza dwar M. tuberculosis, li hija meqjusa tikkettar tal-klassi u li hija inkluża filKarta tad-Dejta Ewlenija tal-Kumpanija (CCDS).
English: As a fluoroquinolone antibacterial agent, levofloxacin inhibits DNA synthesis by acting on the DNA/DNA-gyrase complex and topoisomerase IV.
Maltese: Bħala aġent antibatterjali ta' fluorokwinolone, levofloxacin jinibixxi s-sinteżi tad-DNA billi jaġixxi fuq il-kumpless tad-DNA/DNAġirażi u topoisomerażi IV.
English: The warning on tendinitis and tendon rupture was amended to state that the risk of tendinitis and tendon rupture is increased in patients receiving daily doses of 1000 mg.
Maltese: It-twissija fuq tendonite u l-ftuq tat-tendon ġiet emendata sabiex tiddikjara li r-riskju ta' tendonite u ftuq tat-tendon jiżdied f'pazjenti li jirċievu dożaġġi ta' kuljum ta' 1000 mg.
English: In clinical practice, the most commonly prescribed antibiotics for sinusitis are betalactams (amoxicillin with or without clavulanic acid, oral second and third-generation cephalosporins), macrolides, and antipneumococcal fluoroquinolones.
Maltese: Fil-prattika klinika, l-aktar antibijotiċi preskritti b'mod komuni għas-sinożite huma betalactams (amoxicillin ma' jew mingħajr aċidu klavulaniku, ċefalosporini orali tat-tieni jew tielet ġenerazzjoni), makrolidi, u fluorokwinoloni antipnewmokokkali.
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information
Maltese: • Il-kumitat analizza d-dejta sottomessa mill-MAH mill-istudji kliniċi eżistenti, id-dejta dwar il-farmakoviġilanza u t-tagħrif ippubblikat li jiġġustifikaw l-armonizzazzjoni proposta talinformazzjoni dwar il-prodott
English: The MAH agreed that the harmonised wording for levofloxacin should also be in line with wording for other fluoroquinolones.
Maltese: L-MAH qabel li t-test armonizzat għal levofloxacin għandu jkun konformi wkoll mat-test għal fluorokwinoloni oħrajn.
English: The warning on prevention of photosensitisation was revised to further recommend precaution during treatment and 48 hours following treatment discontinuation.
Maltese: It-twissija dwar il-prevenzjoni ta' fotosensitizzazzjoni ġiet riveduta sabiex tirrakkomanda ulterjorment għaqal matul it-trattament u 48 siegħa wara li jitwaqqaf it-trattament.
English: The evidence was provided by the MAH including a cumulative review of all fatal cases due to hepatibilary disorders.
Maltese: Levidenza kienet ipprovduta mill-MAH inkluża analiżi kumulattiva tal-każijiet fatali kollha dovuti għal disturbi epatobiljari.
English: There are differences between Member States concerning the individual paragraphs in this section.
Maltese: Hemm differenzi bejn l-Istati Membri fil-paragrafi individwali f'din is-sezzjoni.
English: The warning on the superinfection was amended in line with the standard wording on this point included in the PI for all antibacterial agents.
Maltese: It-twissija dwar is-superinfezzjoni ġiet emendata b'konformità mat-test standard dwar dan il-punt inkluż fil-PI għall-sustanzi antibatterjali kollha.
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Maltese: Minn hawn 'il quddiem sejrin jingħataw f'sinteżi l-punti ewlenin diskussi għall-armonizzazzjoni tassezzjonijiet differenti tal-SmPC.
English: Since uUTI is defined as a presence of episodes of acute cystitis and acute pyelonephritism, the MAH proposed to harmonise this indication for “uncomplicated cystitis” to better reflect the patients population included in the study.
Maltese: Peress li uUTI hija definita bħala preżenza ta' episodji ta' ċistite akuta u pjelonefritiżma akuta, il-MAH ippropona li din l-indikazzjoni tiġi armonizzata għal “ċistite mhux ikkumplikata” sabiex tiġi riflessa aħjar il popolazzjoni tal-pazjenti inkluża fl-istudji.
English: Due to the combination of the MRP and National granted MAs some divergent information has been identified in the product information (PI) for Tavanic.
Maltese: Minħabba t-taħlita tal-MRP u l-MAs approvati b'mod nazzjonali, ġie identifikat xi tagħrif diverġenti fl-informazzjoni dwar il-prodott (PI) għal Tavanic.
English: Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections) in severe cases at risk of complications (such as frontal, sphenoidal, ethmoidal or pansinusitis), or in case of known or suspected bacterial resistance to commonly used classes of anti-infectives (according to history of patients or national and /or regional resistance data), or if previous anti-infective treatment has failed.
Maltese: Sinożite batterjali akuta (adegwatament djanjostikata skont linji gwida nazzjonali u/jew lokali dwar it-trattament ta' infezzjonijiet fl-apparat respiratorju) f'bosta każijiet f'riskju ta' kumplikazzjonijiet (bħal frontali, sfenojdali, etmojdali jew pansinusite), jew f'każ ta' reżistenza batterjali magħrufa jew issuspettata għal klassijiet użati b'mod komuni ta' antinfettivi (skont l-istorja medika talpazjenti jew dejta dwar ir-reżistenza nazzjonali u / jew reġjonali), jew jekk ikun falla t-trattament infettiv preċedenti.
English: Therefore, on the basis of the efficacy data provided by the MAH for ABS, Pharmacokinetic/Pharmacodynamic considerations and the extensive risk profile of levofloxacin, it was agreed that the wording for the ABS indication should be in line with the wording agreed for other the fluoroquinolon agents.
Maltese: Għaldaqstant, fuq il-bażi tad-dejta dwar l-effikaċja pprovduta mill-MAH għall-ABS, ilkunsiderazzjonijiet Farmakokinetiċi/Farmakodinamiċi u l-profil ta' riskju estensiv ta' levofloxacin, sar qbil dwar il-fatt li t-test għall-indikazzjoni tal-ABS għandu jkun konformi mat-test maqbul għal sustanzi fluorokwinolon oħrajn.
English: The proposal presented by the MAH reflected the latest scientific information including Core Safety Information (harmonisation of the safety sections of the SmPC: 4.3 to 4.9) agreed in April 2011 as an outcome of the PSUR worksharing, recent safety reviews of fluoroquinolones and new worldwide data on safety of fluoroquinolon.
Maltese: Ilproposta ppreżentata mill-MAH irriflettiet l-aħħar tagħrif xjentifiku inkluża l-Informazzjoni Ewlenija dwar is-Sigurtà (armonizzazzjoni tas-sezzjonijiet dwar is-sigurtà tal-SmPC: 4.3 sa 4.9) li sar qbil dwarha f'April 2011 bħala eżitu tal-qsim tax-xogħol tal-PSUR, analiżijiet riċenti tas-sigurtà ta' fluorokwinoloni u dejta ġdida minn madwar id-dinja dwar is-sigurtà ta' fluorokwinolon.
English: EU/1/14/982/001
Maltese: EU/1/14/982/001 Viekirax
English: 56 (4x14) tablets (multipack)
Maltese: 56 (4x14) pilloli (pakkett multiplu)
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/Alu)
Maltese: Folja (PVC/PE/PCTFE/Alu)
English: Viekirax
Maltese: Mnejn għandu jingħata
English: groin, tumour).
Maltese: groin, tumur).
English: Study AV-951-09-301
Maltese: Studju AV-951-09-301
English: Do not take Fotivda:
Maltese: Tiħux Fotivda:
English: • nafcillin, rifampicin, rifabutin, rifapentin (antibiotics);
Maltese: • nafcillin, rifampicin, rifabutin, rifapentin (antibijotiċi);
English: 1 Goitre including goitre and toxic nodular goitre
Maltese: 1 Goitre inkluż goitre u goitre nodulari tossiku
English: P-value (Log rank test)
Maltese: Valur p nominali (Test ta' Log rank)
English: The active substance is tivozanib.
Maltese: Is-sustanza attiva hi tivozanib.
English: Gastrointestinal perforation/fistula
Maltese: Perforazzjoni gastrointestinali/fistula
English: System Organ Class
Maltese: Sistema talKlassiifika talOrgani
English: Urticaria Dermatitis26
Maltese: Dermatite26
English: CYP and UGT in vitro studies
Maltese: CYP u UGT studji in vitro
English: See also Section 4 “Possible side effects”.
Maltese: Ara wkoll it-Taqsima 4 "Effetti sekondarji possibbli ".
English: • Swelling or irritation of the mucous membranes.
Maltese: • Nefħa jew irritazzjoni tal-membrani mukużi.
English: • phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
Maltese: • phenobarbital, phenytoin, carbamazepine (użati biex jikkuraw l-epilessija);
English: The intent-to-treat (ITT) population included 517 patients, 260 randomised to tivozanib and 257 randomised to sorafenib.
Maltese: Il-popolazzjoni tal-intenzjoni li tikkura (ITT) inkludiet 517-il pazjent, 260 randomizzat b'tivozanib u 257 randomizzati b'sorafenib.
English: Fotivda 890 microgram hard capsules EU/1/17/1215/001
Maltese: Fotivda 890 mikrogramma kapsuli iebsin EU/1/17/1215/001
English: Endocrine disorders
Maltese: Disturbi endokrinali
English: • dexamethasone (a corticosteroid to reduce inflammation and treat disorders of the immune system);
Maltese: • dexamethasone (kortikosterojde li jnaqqas infjammazzjoni u jittratta disturbi tas-sistema immunitarja);
English: Fotivda 1340 microgram
Maltese: Fotivda 1340 mikrogramma
English: Figure 1: Kaplan-Meier plot of progression free survival, independent radiological review (ITT Population)
Maltese: Figura 1: Plott Kaplan Meier ta' sopravivenza mingħajr progressjoni, reviżjoni radjoloġika indipendenti (ITT Popolazzjoni)
English: Arthralgia Myalgia Musculoskeletal chest pain
Maltese: Arthralġja Majalġja Uġigħ muskuloskeletali fis sider
English: Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) (see section 4.5).
Maltese: Il-koamministrazzjoni ma' preparazzjonijiet erbali li fihom St.John' s wort (Hypericum perforatum) (ara sezzjoni 4.5).
English: Fotivda 1340 microgram hard capsules EU/1/17/1215/002
Maltese: Fotivda 1340 mikrogramma kapsuli iebsin EU/1/17/1215/002
English: One patient experienced Grade 4 PRES and hypertension in Study AV-951-09-901.
Maltese: Grad 4 PRES u pressjoni għolja fl-Istudju AV-951-09-901.
English: Transporter in vitro studies
Maltese: Trasportatur fi studji in vitro
English: The most common adverse reactions of any grade include hypertension (47.6%), dysphonia (26.9%), fatigue (25.8%) and diarrhoea (25.5%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni ta' kwalunkwe grad jinkludi ipertensjoni (47.6%), disfonja (26.9%), għeja (25.8%) u dijarea (25.5%).
English: Flushing13
Maltese: Fwawar13
English: Fungal infection Pustular rash
Maltese: Infezzjonijiet fungali Raxx pustulari
English: Table 1: Tabulated list of adverse reactions (presented using frequencies for all-causality adverse events)
Maltese: Tabella 1: Lista tabulata ta' reazzjonijiet avversi (ippreżentati bl-użu ta' frekwenzi għal avvenimenti avversi ta' kull każwalità)
English: Objective Response Rate (95% CI), ITT Population
Maltese: Rata ta' Rispons Oġġettiv (95% CI), ITT Popolazzjoni
English: median OS was 28.2 months (95% CI 22.5, 33.0) in the tivozanib arm compared to 30.8 months (95% CI 28.4, 33.3) in the sorafenib arm (HR=1.147, p=0.276).
Maltese: L-OS medjan kien 28.2 xhur (95% CI 22.5, 33.0) fil-grupp ta' tivozanib meta mqabbel ma' 30.8 xhur (95% CI 28.4, 33.3) fil-grupp ta' sorafenib (HR = 1.147, p=0.276).
English: Posterior reversible encephalopathy syndrome (PRES)5
Maltese: Sindromu talenċefalopatija riversibbli posterjuri (PRES)5
English: Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Maltese: Tivozanib wera titjib sinifikanti statistikament fil-PFS u ORR fuq sorafenib minn reviżjoni ta' radjoloġija indipendenti (Tabella 2 u Figura 1).
English: Arterial thromboembolism10
Maltese: Tromboemboliżmu arterjali10
English: Both events were CTC Grade 3 (see section 4.4).
Maltese: Iż-żewġ avvenimenti kienu CTC Grad 3 (ara sezzjoni 4.4).
English: Duodenal ulcer
Maltese: Ulċera duwodenali
English: 6 Vision impairment including reduced visual acuity, vision blurred and visual impairment 7 Myocardial infarction (acute) / ischaemia including acute myocardial infarction, ischaemia and myocardial infarction 8 Tachycardia including sinus tachycardia, supraventricular tachycardia, tachycardia and tachycardia paroxysmal 9 Haemorrhage including adrenal haemorrhage, anal haemorrhage, cervix haemorrhage uterine, duodenal ulcer haemorrhage, gingival bleeding, haematemesis, haemoptysis, haemorrhagic anaemia, haemorrhagic erosive gastritis,
Maltese: Indeboliment fil-vista inkluż akutezza tal-vista mnaqqsa, vista mċajpra u tnaqqis fil-vista 7 Infart mijokardijaku (akut) / iskemija inkluż infart mijokardijaku akut, iskemija u infart mijokardijaku 8 Takikardija inkluż takikardja tas-sinus, takikardja supraventrikulari, takikardja u takikardja parossimali 9 Emorraġija inkluż emorraġija adrenali, emorraġija anali, emorraġija taċ-ċerviċi tal-utru, emorraġija tal-ulċera duwodenali, fsada fil-ħanek, ematemesi, emoptisi, anemija emorraġika, gastrite erożiva emorraġika, puplesija emorraġika, emorraġija fil-ħalq, emorraġija pulmonari u emorraġija fil-passaġġ respiratorju
English: 2 Peripheral neuropathy including hyperaesthesia, hypoaesthesia, mononeuropathy, neuropathy peripheral, peripheral sensory neuropathy and paraesthesia
Maltese: 2 Newropatija perferali inklużi iperestesija, ipoestesija, mononewropatija, newropatija periferali, newropatija sensorjali periferali u parasteżija
English: In vitro studies conducted in human liver microsomes and hepatocytes evaluating the activity of CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 suggested that tivozanib is a weak inhibitor of CYP2B6 and CYP2C8.
Maltese: Studji in vitro b'tivozanib jindikaw li mhuwiex induttur tal-enzima CYP. Studji in vitro li saru fuq mikrosomi tal-fwied uman u epatoċiti li jevalwaw l-attività ta' CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 u CYP3A4 ssuġġeriet li tivozanib huwa inibitur dgħajjef ta' CYP2B6 u CYP2C8.
English: • Posterior reversible encephalopathy syndrome (PRES).
Maltese: • Sindromu tal-enċefalopatija riversibbli posterjuri (PRES).
English: Pharmacotherapeutic group: antineoplastic agents, protein-kinase inhibitors, ATC code: L01XE34
Maltese: Aġenti antineoplastiċi, inibituri kinasi-proteina, Kodiċi ATC:
English: Myocardial infarction (acute) / ischaemia7 Angina pectoris Tachycardia8
Maltese: Infart mijokardijaku (akut) / iskemija7
English: In vitro metabolism studies have shown that CYP3A4 and CYP1A1 are capable of metabolising tivozanib.
Maltese: Studji tal-metaboliżmu in vitro wrew li CYP3A4 u CYP1A1 huma kapaċi li jimmetabolizzaw tivozanib.
English: 7 days (1 week)
Maltese: 7 ijiem (ġimgħa)
English: Cross-over to the tivozanib arm was permitted upon Response Evaluation Criteria In Solid Tumours (RECIST)-defined progression on sorafenib according to the protocol of a separate extension study.
Maltese: Kien permess li jaqsam għall-grupp tivozanib fuq Kriterji ta' Evalwazzjoni tar-Rispons Fit-Tumuri Solidi (RECIST) progressjoni definita fuq sorafenib skont il-protokoll ta' studju ta' estensjoni separata.
English: Printing ink (blue) Shellac
Maltese: Linka tal-istampar (blu) Shellac
English: Skin exfoliation Erythema22 Pruritus23
Maltese: Ġilda titqaxxar Eritema22 Prurite23 Alopeċja Raxx24
English: In vitro studies have shown that metabolites of tivozanib can undergo UGT mediated biotransformation via the UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9, and UGT1A10 pathways.
Maltese: Studji in vitro wrew li l-metaboliti ta' tivozanib jistgħu jgħaddu minn bijotrasformazzjoni medjata UGT permezz tas-sistemi UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9, u UGT1A10.
English: In the pivotal study, the dose was reduced for grade 3 events and interrupted for grade 4 events.
Maltese: Fl-istudju pivotali, id-doża tnaqqset għal avvenimenti ta' grad 3 u ġiet interrotta għal avvenimenti ta' grad 4.
English: In vitro protein binding studies have shown that tivozanib is > 99% bound to plasma proteins.
Maltese: Studji marbuta ma' proteina in vitro wrew li tivozanib huwa > 99% marbut mal-proteini tal-plażma.
English: Proteinuria Blood creatinine increased
Maltese: Proteina fl-awrina
English: QT/QTc prolongation
Maltese: Titwil fil-QT/QTc
English: The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor.
Maltese: Is-sustanza attiva Fotivda hi tivozanib, li huwa inibitur tal-proteina kinase.
English: Progression-Free Survival [median, months (95% CI)], ITT Population
Maltese: Progressjoni [medjan, xhur (95% CI)], ITT Popolazjoni
English: Direct N-glucoronidation of tivozanib was a minor pathway of metabolism in vitro.
Maltese: N-glukoronidazzjoni diretta ta' tivozanib kienet sistema minuri tal-metaboliżmu in vitro.
English: - Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminium lake (E132).
Maltese: - Linka tal-istampar, blu: shellac, glikol tal-propylene, soluzzjoni qawwija tal-ammonju, indigo carmine aluminium lake (E132).
English: Studies conducted in vitro have shown that tivozanib is not a potent inhibitor of UGT (UDP-glucuronosyltransferase) metabolic activities and clinically relevant drug-drug interactions are unlikely with medicinal products metabolised by these pathways.
Maltese: Studji mwettqa in vitro wrew li tivozanib mhuwiex inibitur potenti ta' attivitajiet metaboliċi UGT (UDP glukuronosiltransferase) u interazzjonijiet klinikament rilevanti tad-droga mhux probabbli ma' prodotti mediċinali metabolizzati minn dawn is-sistemi.
English: Arterial thromboembolic adverse reactions in the patients receiving tivozanib as initial therapy were ischaemic stroke (1.0%), myocardial infarction (0.7%), transient ischaemic attack (0.7%) and acute myocardial infarction (0.4%), the majority of which were at least CTC Grade 3, plus iliac artery thrombosis (0.1%).
Maltese: Reazzjonijiet avversi tromboemboliċi arterjali fil-pazjenti li rċevew tivozanib bħala terapija inizjali kienu puplesija iskemika (1.0%), infart mijokardijaku (0.7%), attakk iskemiku temporanju (0.7%) u infart mijokardijaku akut (0.4%), li l-maġġoranza minnhom kienu mill-inqas CTC grad 3, flimkien ma' trombożi tal-arterja tal-ilju (0.1%).
English: • Rashes with pus; fungal infections.
Maltese: • Raxx bil-materja; infezzjonijiet fungali
English: 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 available data).
Maltese: Il-frekwenzi huma definiti kif ġej: 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 magħruf (ma tistax tiġi evalwata mid-data disponibbli).
English: Exposure is dose proportional between 890 and 1340 microgram and dose related over the wider range of 450 mg and 1790 microgram.
Maltese: L-espożizzjoni hija doża proporzjonali bejn 890 u 1340 mikrogrammi u d-doża relatata fuq medda usa' ta' 450 mg u 1790 mikrogramma.
English: In a clinical study in healthy volunteers, co-administration of a single 1340 microgram dose of tivozanib with a strong CYP3A4 inducer at steady-state (rifampin 600 mg once daily) decreased the average half-life of tivozanib from 121 to 54 hours which was associated with a decrease in the single dose AUC0-∞ of 48% compared with AUC0-∞ in the absence of rifampin.
Maltese: Fi studju kliniku f'voluntiera f'saħħithom, il-koamministrazzjoni ta' doża waħda ta' 1340 mikrogramma ta' tivozanib ma' induttur qawwi ta' CYP3A4 fi stat stabbli (rifampin 600 mg darba kuljum) naqqas in-nofs ħajja medja ta' tivozanib minn 121 sa 54 siegħa li kienet assoċjata ma' tnaqqas fid-doża waħdanija AUC0-∞ ta' 48% meta mqabbel ma' AUC0-∞ fin-nuqqas ta' rifampin.
English: The other ingredients are: - Capsule content: mannitol, magnesium stearate.
Maltese: - Kontrenut tal-kapsula: mannitol, stearat tal-manjesju.
English: Average Cmax and AUC0-24hr were not significantly affected (8% increase and 6% decrease respectively).
Maltese: Cmax medja u AUC0-24hr ma kinux affettwati b'mod sinifikanti (żieda ta' 8% u 6% tnaqqis rispettivament).
English: • Joint pain; muscle pain.
Maltese: • Uġigħ fil-ġogi; uġigħ fil-muskoli.
English: Palmar-plantar erythrodysaesthesia syndrome / Hand foot skin reaction (PPE/HFS)
Maltese: Sindrome tal-idejn u ssaqajn (HFS/PPE)
English: Propylene glycol
Maltese: Glikol tal-propylene
English: [14C] Tivozanib was the predominant drug-related material in faeces.
Maltese: [14C] Tivozanib kien il-materjal predominanti relatata mal-mediċina fl-ippurgar.
English: Tivozanib inhibits the transporter protein BCRP in vitro, at concentrations that are likely to restrict the effect to intestinal BCRP activity in vivo.
Maltese: Tivozanib jinibixxi l-proteina trasportatur BCRP in vitro, f'konċentrazzjonijiet li jistgħu jirrestrinġu l-effett lil attività BCRP intestinali in vivo.
English: Propylene glycol Strong ammonia solution Titanium dioxide (E171) Tartrazine aluminium lake (E102)
Maltese: Strong ammonia solution Diossidu tat-titanju (E171) Tartrazine aluminium lake (E102)
English: Each hard capsule contains trace amounts of tartrazine (E102) (8-12% of the yellow printing ink composition) (see section 4.4).
Maltese: Kull kapsula iebsa fiha ammonti żgħar ħafna ta' tartrazine (E102) (8-12% tal-kompożizzjoni tal-linka safra tal-istampar) (ara sezzjoni 4.4).
English: Risk factors for VTEs include major surgery, multiple trauma, prior VTEs, advanced age, obesity, cardiac or respiratory failure, and prolonged immobility.
Maltese: Fatturi ta' riskju għall-VTEs jinkludu kirurġija maġġuri, trawma multipla, VTEs minn qabel, età avvanzata, l-obeżità, insuffiċjenza kardijaka jew respiratorja, u immobilità fit-tul.
English: Strong ammonia solution Indigo carmine aluminium lake (E132)
Maltese: Indigo carmine aluminium lake (E132)
English: The maximum change in QTcF from baseline was 9.3 ms (90% CI: 5, 13.6), which occurred 2.5 hours after dosing on Day 21.
Maltese: Il-bidla massima fil-QTcF mill-linja bażi kienet 9.3 ms (90% CI: 5, 13.6), li seħħet 2.5 sigħat wara d-dożaġġ fil-21 jum.
English: Dizziness Dysgeusia3
Maltese: Disfonija Sogħla
English: Tartrazine Fotivda 890 microgram hard capsules contain tartrazine (E102) which may cause allergic reactions.
Maltese: Fotivda 890 mikrogramm kapsuli iebsin fihom tartrazine (E102) li jistgħu jikkawżaw reazzjonijiet allerġiċi.
English: Fotivda 890 microgram and Fotivda 1340 microgram are available as packs of 21 capsules in HDPE-bottles with child-resistant closure.
Maltese: Fotivda 890 mikrogramma u Fotivda 1340 mikrogramma huma disponibbli bħala pakketti ta' 21 kapsuli fi fliexken HDPE b'tapp reżistenti għat-tfal.