FrancophonIA/ELRC3.0 huggingface dataset:
English: - “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
Maltese: - “Sindrome ta' tnixxija mhux kif suppost tal-ormon antidijuretiku”, li hi kundizzjoni li tikkawża livelli baxxi ta' sodium fid-demm
English: Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes.
Maltese: Javlor jingħatalek minn professjonista kwalifikat/a fil-qasam mediku bħala infużjoni ġol-vini (dripp ġol-vina tiegħek) li ddum 20 minuta.
English: Common Tachycardia Uncommon Myocardial ischaemia
Maltese: Iskemija mijokardijaka Infart mijokardijaku
English: Vinflunine is eliminated following a multi-exponential concentration decay, with a terminal half-life (t1/2) close to 40 h. DVFL is slowly formed and more slowly eliminated than vinflunine (t1/2 of approximately 120 h).
Maltese: DVFL hu ffurmat bil-mod u eliminat aktar bil-mod mill-vinflunine (t1/2 ta' bejn wieħed u ieħor 120 siegħa).
English: Common Ileus Dysphagia
Maltese: Soluzzjoni dilwita
English: The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Il-volum ta' Javlor (konċentrat) li jikkorrespondi mad-doża kkalkulata ta' vinflunine għandu jitħallat ġo borza ta' 100ml klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-infużjoni.
English: In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine.
Maltese: II total ta' 202 pazjent kienu kkurati bil-vinflunine.
English: NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon.
Maltese: Grad 3 stitikezza hi definita bħala stitikezza esaġerata li jkollha bżonn evakwazzjoni manwali jew enema, Grad 4 stitikezza bħala ostruzzjoni jew megakolon tossika.
English: *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0) 1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon.
Maltese: 2 *Istitut Nazzjonali tal-Kanċer, Kriterji ta' Tossiċità Komuni Verżjoni 2.0 (NCI -CTC v 2.0) 1 NCI CTC Grad 2 stitikezza hi definita bħala bżonn ta' lassattivi, Grad 3 bħala stitikezza esaġerata li jkollha bżonn evakwazzjoni manwali jew enema, Grad 4 bħala ostruzzjoni jew megakolon tossika.Mukożite Grad 2 hi definita bħala “moderata”, Grad 3 bħala “serja” u Grad 4 bħala “theddida għall-ħajja”
English: All metabolites identified are formed by the cytochrome CYP3A4 isoenzyme, except for 4-O-deacetylvinflunine (DVFL), the only active metabolite and main metabolite in blood which is formed by multiple esterases.
Maltese: Il-metaboliti kollha identifikati huma ffurmati mill-iżoenżima ċitokroma CYP3A4, ħlief għall4Odeaċetilvinflunine (DVFL), l-uniku metabolit attiv u metabolit ewlieni fid-demm li jifforma minn esterasi multipli.
English: Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0) 1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon.
Maltese: Kull Grad ieħor ta' tossiċità ≥ 3(serju jew ta' theddida għall-ħajja) (għajr rimettar jew dardir ta' Grad 3) 2 *Istitut Nazzjonali tal-Kanċer, Kriterji ta' Tossiċità Komuni Verżjoni 2.0 (NCI -CTC v 2.0) 1 NCI CTC Grad 2 stitikezza hi definita bħala bżonn ta' lassattivi, Grad 3 bħala stitikezza esaġerata li jkollha bżonn evakwazzjoni manwali jew enema, Grad 4 bħala ostruzzjoni jew megakolon tossika.Mukożite Grad 2 hi definita bħala “moderata”, Grad 3 bħala “serja” u Grad 4 bħala “theddida għall-ħajja” 2 NCI CTC
English: Hepatic impairment The recommended dose should be reduced in patients with hepatic impairment (see section 4.2).
Maltese: Id-doża rakkomandata għandha tiġi mnaqqsa f'pazjenti b'indeboliment epatiku (ara sezzjoni 4.2)
English: In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression.
Maltese: B'mod partikolari, għandek tgħid lit-tabib tiegħek jekk qed tieħu mediċini li fihom wieħed minn dawn is-sustanzi attivi li ġejjin: - ketokonażol u itrakonażol, użati biex jikkuraw infezzjoni fungali, - opjojdi, użati għall-kura tal-uġigħ, - ritonavir, użat biex jikkura infezzjoni tal-HIV, - doksorubiċin u peġilat liposomali, użat biex jikkura xi tipi ta' kanċer, - rifampiċin, użat biex jikkura tuberkulosi jew meninġitide, - preparazzjoni bil-ħxejjex li fihom ipericum perforatum (St John's wort) użat biex jikkura depressjoni mhux serja sa moderata.
English: This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Maltese: Dan l-effett jista' jwassal għal żieda fir-riskju ta' arritmija ventrikulari għalkemm ma ġew osservati l-ebda arritmija ventrikulari bil- vinflunine.
English: In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration (see section 4.4).
Maltese: Sabiex tevita stitikezza, lassattivi u miżuri tad-dieta inkluż idratazzjoni orali huma rakkomandati minn jum 1 sa jum 5 jew 7 wara kull amministrazzjoni ta' vinflunine (ara sezzjoni 4.4).
English: Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine
Maltese: Tabella 4 Reazzjonijiet avversi osservati f'pazjenti b'karċinoma taċ-ċelluli transizzjonali talurotelju ikkurat bil-vinflunine
English: Tell your doctor immediately if you develop any of the following serious side effects while being treated with Javlor: - fever and / or chills which could be signs of infection, - chest pain which could be sign of heart attack, - constipation that resists to laxative treatment, - headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as “posterior reversible encephalopathy syndrome” (see section 2 “warnings and precautions”).
Maltese: - stitikezza li ma ċċedix bil-kura tal-lassattivi, - uġigħ ta' ras, tibdil fl'istat mentali li jista' jwassal għal konfużjoni u koma, konvulżjonijiet, vista mċajpra u pressjoni għolja, li jistgħu ikunu sinjali ta' disturbazzjoni newroloġika bħal “sindrome riversibbli ta' enċefalopatija posterjuri” (ara sezzjoni 2 “twissijiet u prekawzjonijiet”).
English: One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
Maltese: Kunjett wieħed ta' 10 mL jikkuntieni 250 mg ta' vinflunine (bħala ditartrat).
English: Very common Neutropenia Leucopenia Anaemia Thrombocytopenia Common Febrile neutropenia Immune system disorders Common Hypersensitivity
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: XX month YYYY
Maltese: X'inhu Javlor u gћalxiex jintuża
English: - in patients 80 years old and above, the dose of vinflunine to be given is 250 mg/m² every 3 weeks.
Maltese: - f'pazjenti ta' 80 sena u iktar, id-doża ta' vinflunine li għandha tingħata hija ta' 250 mg/m² kull 3 ġimgħat.
English: Vinflunine has not been evaluated in patients with severe hepatic impairment (Child-Pugh grade C), or in patients with a prothrombin time < 50%NV or with bilirubin > 5xULN or with isolated transaminases > 2.5xULN ( ≥ 5xULN only in case of liver metastases) or with GGT > 15xULN.
Maltese: Il-vinflunine ma ġiex evalwat f'pazjenti b'indeboliment tal-fwied sever (b'grad Child-Pugh C), jew f'pazjenti b'ħin protrombin < 50% NV jew b'bilirubin >5xULN jew b'transaminasi iżolati > 2.5xULN
English: • A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line.
Maltese: • Aċċess għal ġol-vina għandu jiġi stabbilit għal borża ta' 500ml klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-infużjoni jew glukosju 50 mg/mL (5%) soluzzjoni għall-infużjoni, fuq vina kbira preferibbilment fil-parti ta' fuq tad-driegħ mill-minkeb 'l isfel jew billi tintuża linja venuża ċentrali.
English: Vinflunine initial dose of 320 mg/m²
Maltese: Doża inizzjali ta' vinflunine ta' 320 mg/m² Doża inizzjali ta' vinflunine ta' 280 mg/m²
English: Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Maltese: Javlor għandu jingħata b'infużjoni ġol-vina ta' 20 minuta u MA JINGĦATAX b'bolus rapidu ġol-vini.
English: Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Maltese: Espożizzjoni tad-demm għall-vinflunine (AUC), ikkorrelata sinjifikament mas-severità tal-lewkopenji,
English: In the eligible population, the subgroup analyses according to the prior cisplatin use versus BSC on overall survival (OS) showed a HR (95% CI) = [0.64 (0.40 - 1.03); p=0.0821] in the absence of prior cisplatin, and a HR (95% CI) = [0.80 (0.60 - 1.06); p=0.1263] in the presence of prior cisplatin.
Maltese: BSC fuq sopravivenza totali (OS) wera HR (95% CI) = [0.64 (0.40 - 1.03); p=0.0821] fl-assenza ta' ċisplastin preċedenti.
English: In patients with moderate renal impairment (40 mL/min ≤ CrCl ≤ 60 mL/min), the recommended dose is 280 mg/m² given once every 3 weeks.
Maltese: F'pazjenti b'indeboliment renali moderat (40 mL/min ≤ CrCl ≤ 60 mL/min), id-doża rakkomandata hi ta' 280 mg/m² mogħtija darba kull tliet ġimgħat.
English: 280 mg/m² 250 mg/m²
Maltese: 280 mg/m²
English: One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
Maltese: Pazjent wieħed miet wara infart mijokardijaku u ieħor minħabba arrest kardjopulmonari.
English: Hematological toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: When adjusted on prognostic factors, the analyses of OS in the subgroups of patients without or with prior cisplatin showed a HR (95% CI) = [0.53 (0.32 - 0.88); p=0.0143] and a HR (95% CI) = [0.70 (0.530.94); p=0.0174], respectively.
Maltese: HR (95% CI) = [0.70 (0.53 - 0.94); p=0.0174], rispettivament.
English: 2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids.
Maltese: Grad 3 dardir hu definit bħala ebda teħid sinifikanti, li jirrikjedi fluwidi ġol-vini.
English: In the multi-centre, open-label controlled phase III clinical trial, 253 patients were randomised to treatment with vinflunine + BSC (best supportive care) and 117 patients to the BSC arm.
Maltese: III, 253 pazjent kienu magħżula bladdoċċ għall-kura bil-vinflunine + BSC (l-aħjar assistenza ta' għajnuna) u 117 pazjent għad-driegħ
English: Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Maltese: Javlor 25 mg/mL konċentrat għall-soluzzjoni għall-infużjoni vinflunine
English: When adjusted on prognostic factors, the analyses of PFS in the subgroups of patients without or with prior cisplatin showed a HR (95% CI) = [0.51(0.31 - 0.86); p=0.0111] and a HR (95% CI) = [0.63(0.48 - 0.84); p=0.0016], respectively.
Maltese: Meta aġġustat fuq fatturi prognostiċi, , l-analiżi tal-PFS fis-sotto-gruppi ta' f'pazjenti mingħajr jew bl-użu preċedenti ta' ċisplastin urew HR (95% CI) = [0.51(0.31 - 0.86); p=0.0111] u HR
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with doxorubicin.
Maltese: L'ebda interazzjoni farmakokinetika ma kienet osservata f'pazjenti meta l-vinflunine kienet kumbinata ma' doksorubiċin.
English: Uncommon Extravasation
Maltese: Sensittività eċċessiva
English: - if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
Maltese: - jekk inti allerġiku għas-sustanza attiva (vinflunine) jew għal vinka alkalojdi oħrajn (vinblastin, vinkristin, vindesin, vinorelbin),
English: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen
Maltese: Javlor huwa indikat fil-monoterapija għall-kura ta' pazjenti adulti b'karċinoma fiċ-ċelloli transizzjonali avvanzat jew metastatiku tal-apparat uroteljali wara falliment ta' dieta preċedenti li fih il-platinu.
English: In addition a pre-specified multivariate analysis performed on the ITT population demonstrated that vinflunine had a statistically significant treatment effect (p=0.036) on overall survival when prognostic factors (PS, visceral involvement, alkaline phosphatases, haemoglobin, pelvic irradiation) were taken into consideration; hazard ratio 0.77 (95% CI 0.61, 0.98).
Maltese: Barra dan, analiżi pre-speċifikata multivarjata li saret fuq il-popolazzjoni tal-ITT wriet li l-vinflunine kellu effett ta' kura statistikament sinjifikanti (p=0.036) fuq is-sopravivenza totali meta fatturi prognostiċi (PS, involviment tal-vixxri, fosfatasi alkalini, emoglobina, irradjazzjoni fil-pelvi) kienu meħuda f'konsiderazzjoni; proporzjon ta' riskju 0.
English: Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Maltese: Effetti fuq il-qalb huma effetti magħrufa tal-klassi tal-vinka alkalojdi.
English: Few QT interval prolongations have been observed after the administration of vinflunine.
Maltese: Ftit dewmien fl-intervall QT kienu osservati wara l-amministrazzjoni tal-vinflunine.
English: Musculoskeletal and connective tissue disorders
Maltese: - disturbi fil-kontrazzjoni tal-muskoli,
English: Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Maltese: Javlor fih is-sustanza attiva vinflunine, li jappartieni lil grupp ta' mediċini kontra l-kanċer li jissejħu vinka alkalojdi.
English: Therefore, risks of clinically significant interactions should be unlikely.
Maltese: B'hekk, riskji ta' effetti sinifikanti kliniċi jistgħu ma jkunux probabbli.
English: Myocardial infarction
Maltese: Disturbi gastro-intestinali
English: Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly higher than those in blood.
Maltese: L-istudji ta' distribuzzjoni ta'immaġnijiet wara vinflunine radjuattiv fil-firien urew li l-livelli komposti fil-pulmuni, kliewi, fwied, il-glandoli salivarji u endokrinarji, l-apparat gastro-intestinali kienu veloċement ogħla minn dawk fid-demm.
English: Renal and urinary disorders
Maltese: - problemi urinarji
English: According to an in vitro study, such changes could be related to adsorption of vinflunine on the liposomes and a modified blood distribution of both compounds.
Maltese: assorbiment ta' vinflunine fuq il-liposomi u distribuzzjoni modifikata tad-demm taż-żewġ kompożizzjonijiet.
English: Adverse reactions in all indications
Maltese: Reazzjonijiet avversi fl-indikazzjonijiet kollha
English: In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
Maltese: Studji in vitro wrew li l-vinflunine hu Pgp-substrat simili għal vinka alkalojdi oħra, imma b'affinità iktar baxxa.
English: 3rd consecutive event
Maltese: It-2 episodju konsekuttiv
English: Musculoskeletal pain
Maltese: Żieda fit transaminasi
English: Men and women with reproductive potential must use an effective method of contraception during the treatment and up to 3 months after the last vinflunine administration (see section 4.6).
Maltese: Kontraċezzjoni Irġiel u nisa b'potenzjali riproduttivi għandhom jużaw metodu effettiv ta' kontraċezzjoni waqt il-kura u sa tliet xhur wara l-aħħar amministrazzjoni tal-vinflunine (ara sezzjoni 4.6).
English: Preclinical data revealed moderate to severe neutropenia and mild anaemia, in all species tested, with liver toxicity in dogs and rats (characterized by dose-dependent increases in liver transaminases and hepatic necrosis/hepatocellular alterations at high doses).
Maltese: Dejta preklinikali żvelat newtropenja moderata għal severa u anemija mhux severa, f'kull speċi eżaminat, b'tossiċità fil-fwied fil-klieb u firien (karatterizzata b'żidiet dipendenti fuq id-dożi fit transaminasi tal-fwied u nekrosi epatika/alterazzjonijiet epatoċellulari b'dożi qawwija).
English: However, this combination was associated with a particularly high risk of haematological toxicity.
Maltese: Madankollu, din il-kumbinazzjoni kienet assoċjata ma' riskju partikolarment għoli ta' tossiċità ematoloġikali.
English: - visual disturbances - dry skin, redness of the skin - muscle contraction disorders - pain in the throat, gum disorders - weight increase - urinary problems - ringing or buzzing in the ears (tinnitus) - increase in liver enzymes (seen in blood test)
Maltese: disturbi gastro-intestinali, speċjalment stitikezza, anoreksja, dardir, stomatite/mukożite, rimettar, uġigħ addominali u dijarea; u disturbi ġenerali bħal astenija/għeja.
English: Common Dyspnoea Cough
Maltese: Dgħjufija muskolari
English: Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have been observed after administration of vinflunine.
Maltese: Sindromu ta' Enċefalopatija Posterjuri Riversibbli (PRES)
English: The recommended dose should be reduced in patients with moderate or severe renal impairment (see section 4.2).
Maltese: Id-doża rakkomandata għandha tiġi mnaqqsa f'pazjenti b'indeboliment renali moderat jew sever (ara sezzjoni 4.2).
English: Definitive Treatment discontinuation
Maltese: Disturbi fis-sistema immuni
English: Hyponatraemia
Maltese: Alopeċja
English: Javlor 25 mg/mL concentrate for solution for infusion
Maltese: Javlor 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni
English: Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Maltese: Informazzjoni għall-utent Javlor 25 mg/mL konċentrat għall-soluzzjoni għall-infużjoni
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jista' jolqot minn 1 sa 100 persuna)
English: Common Hypertension Vein thrombosis Phlebitis
Maltese: Użu fit-tfal u adolexxenti
English: - with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
Maltese: [ transaminasi > ULN u/jew GGT > 5×ULN ],
English: A pharmacokinetic and tolerability phase I study in patients with altered liver functions test has been completed (see section 5.2).
Maltese: Intemm studju ta' fażi I dwar il-farmakokinetika u t-tollerabbiltà f'pazjenti b'test tal-funzjonijiet talfwied mibdul (ara sezzjoni 5.2).
English: Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Maltese: Karatteristiċi kliniċi u radjoloġiċi normalment jiġu solvuti malajr mingħajr sekuweli wara t-twaqqif tat-trattament.
English: Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows:
Maltese: Stabbilità fl-użu kimikali u fiżikali kienet dimostrata għall-prodott mediċinali dilwit kif ġej:
English: For further cycles the dose should be adjusted in the event of toxicities (see section 4.2).
Maltese: Id-doża rakkomandata għandha tiġi mnaqqsa f'pazjenti b'tossiċità ematoloġika) ara sezzjoni 4.2).
English: In a population pharmacokinetic analysis in 372 patients (656 pharmacokinetic profiles), the total blood clearance was 40 l/h with low inter and intra-individual variability (25% and 8%, respectively, expressed as coefficient of variation).
Maltese: It-tneħħija tal-vinflunine u l-metaboliti tiegħu tgħaddi mill-ħara (2/3) u l-awrina F'analiżi farmakokinetika ta' popolazzjoni f'372 pazjent (656 profili farmakokinetiċi), it-tneħħija totali mid-demm kienet ta' 40 l/siegħa b'varjabilità inter- u intra-ndividwali (25% u 8%,
English: In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m².
Maltese: F'każ ta' Skala ta' Kapaċità WHO/ECOG (PS) ta' 1 jew PS ta' 0 u irradjazzjoni preċedenti fil-pelvi,
English: Uncommon Tumour pain
Maltese: Komuni ħafna Newtropenja
English: Very common Hyponatraemia
Maltese: GĦAMLA KWALITATTIVA
English: • The intravenous infusion should be started with half of the 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion, i.e. 250 mL, at a free flowing rate to flush the vein.
Maltese: • L-infużjoni ġol-vina għandha tinbeda b'nofs il-borża ta' 500ml klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-infużjoni jew glukosju 50 mg/mL (5%) soluzzjoni għall-infużjoni, jiġifieri
English: Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Maltese: Tabella 3: Aġġustament tad-doża minħabba tossiċità f'pazjenti b'indeboliment renali jew anzjani
English: Vinflunine did not induce peripheral neuropathy in animals.
Maltese: Vinflunine ma kkaġunax newropatija periferali fl-annimali.
English: Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine.
Maltese: Qabel kull ċiklu, il-monitoraġġ adegwat ta' l-għadd komplet tad-demm għandu jsir biex jiġi vverifikat l-għadd assolut tan-newtrofili (ANC), plejtlits u emoglobina bħala newtropenja, tromboċitopenja u anemija huma reazzjonijiet avversi frekwenti tal-vinflunine.
English: Very common Myalgia Common Muscular weakness Arthralgia
Maltese: Is-soluzzjoni dilwita għandha tintuża immedjatament
English: Constipation is a class effect of the vinca alkaloids: 11.8% of patients experienced severe constipation during treatment with vinflunine.
Maltese: 11.8% tal-pazjenti ġarrbu stitikezza severa waqt ilkura bil-vinflunine.
English: In patients with severe renal impairment (20 mL/min ≤ CrCl < 40 mL/min) the recommended dose is 250 mg/m² every 3 weeks (see section 5.2).
Maltese: F'pazjenti b'indeboliment renali sever (20 mL/min ≤ CrCl < 40 mL/min), id-doża rakkomandata hi ta'
English: - The recommended dose of vinflunine is 250 mg/m² given once every 3 weeks in patients with mild liver impairment (Child-Pugh grade A) or in patients with a prothrombin time ≥ 60% NV and 1.5×ULN < bilirubin ≤ 3×ULN and presenting at least one of the following criteria: [ transaminases > ULN and/or GGT > 5×ULN ].
Maltese: - b'transaminasi ≤ 2.5xULN (< 5xULN biss f'każ ta' metastasi fil-fwied) - Id-doża rakkomandata ta' vinflunine hi 250mg/m² mogħtija darba kull 3 ġimgħat f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh grad A) jew f'pazjenti b'ħin protrombin ≥ 60% NV u
English: Common Insomnia Nervous system disorders Very common Peripheral sensory neuropathy Common Syncope Headache Dizziness Neuralgia Dysgeusia Neuropathy Uncommon Peripheral motor neuropathy 0.4 Rare
Maltese: Is-sintomi kliniċi tipiċi huma, bi gradi varji: newroloġiċi (uġigħ ta' ras, konfużjoni,
English: Elderly patients (≥ 75 years) The recommended dose should be reduced in patients 75 years old and beyond (see section 4.2).
Maltese: Id-doża rakkomandata għandha titnaqqas f'pazjenti ta' 75 sena u iktar (ara sezzjoni 4.2).
English: Buccal disorders Dyspepsia
Maltese: Disturbi fil-ħalq Dispepsja
English: Common Ear pain Uncommon Vertigo
Maltese: Pressjoni għolja b'mod anormali
English: Constipation is a very common side effect of Javlor.
Maltese: JAVLOR jista' jikkawża effetti sekondarji bħal għeja u sturdament.