FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/550/001 (box of 1 vial of 2 mL with grey stopper) EU/1/09/550/002 (box of 10 vials of 2 mL with grey stopper) EU/1/09/550/003 (box of 1 vial of 4 mL with grey stopper) EU/1/09/550/004 (box of 10 vials of 4 mL with grey stopper) EU/1/09/550/005 (box of 1 vial of 10 mL with grey stopper) EU/1/09/550/006 (box of 10 vials of 10 mL with grey stopper) EU/1/09/550/007 (box of 1 vial of 2 mL with black stopper) EU/1/09/550/008 (box of 10 vials of 2 mL with black stopper) EU/1/09/550/009 (box of 1 vial of 4 mL with black stopper) EU/1/09/550/010 (box of 10 vials of 4 mL with black stopper) EU/1/09/550/011 (box of 1 vial of 10 mL with black stopper) EU/1/09/550/012 (box of 10 vials of 10 mL with black stopper)
Maltese: EU/1/09/550/001 (kaxxa ta' kunjett wieħed ta' 2 mL b'tapp griż) EU/1/09/550/002 (kaxxa ta' 10 kunjetti ta' 2 mL b'tapp griż) EU/1/09/550/003 (kaxxa ta' kunjett wieħed ta' 4 mL b'tapp griż) EU/1/09/550/004 (kaxxa ta' 10 kunjetti ta' 4 mL b'tapp griż) EU/1/09/550/005 (kaxxa ta' kunjett wieħed ta' 10 mL b'tapp griż) EU/1/09/550/006 (kaxxa ta' 10 kunjetti ta' 10 mL b'tapp griż) EU/1/09/550/007 (kaxxa ta' kunjett wieħed ta' 2 mL b'tapp iswed) EU/1/09/550/008 (kaxxa ta' 10 kunjetti ta' 2 mL b'tapp iswed) EU/1/09/550/009 (kaxxa ta' kunjett wieħed ta' 4 mL b'tapp iswed) EU/1/09/550/010 (kaxxa ta' 10 kunjetti ta' 4 mL b'tapp iswed) EU/1/09/550/011 (kaxxa ta' kunjett wieħed ta' 10 mL b'tapp iswed) EU/1/09/550/012 (kaxxa ta' 10 kunjetti ta' 10 mL b'tapp iswed)
English: 2D barcode carrying the unique identifier included.
Maltese: 2D barcode li għandu l-identifikatur uniku inkluż.
English: Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Maltese: Sindromu ta' Tnixxija Antidijuretika mhux Addattata (SIADH) a
English: Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Maltese: PFS medjan kien ta' 3 xhur (vinflunine + BSC) kontra 1.5 xhur (BSC) (p=0.0012).
English: In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Maltese: Studji in vitro wrew li l-vinflunine ma kellux effetti stimulanti fuq l-attività CYP1A2, CYP2B6 jew CYP3A4 u lanqas effetti stimulanti fuq CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 u CYP3A4.
English: Thrombocytopenia (platelets < 100,000/mm3)
Maltese: Tromboċitopenja (plejtlets < 100,000/mm3)
English: Elderly (≥ 75 years)
Maltese: Anzjani (≥ 75 sena)
English: The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Maltese: Il-volum terminali tad-distribuzzjoni hu kbir, 2422±676 litri (bejn wieħed u ieħor 35 l/kg) li jissuggerixxi distribuzzjoni fit-tessut.
English: Severe anaemia and thrombocytopenia were less common (respectively 8.8 and 3.1 %).
Maltese: Anemija severa u tromboċitopenja kienu inqas komuni (8.8 u 3.1% rispettivament).
English: Neutropenia (ANC < 1000/mm3 ) or
Maltese: Neutropenja (ANC < 1000 /mm3 ) jew
English: Pack size of 1 and 10 vials.
Maltese: Kull pakkett fih 1 jew 10 kunjetti.
English: Grade 3/4 neutropenia was observed in 43.8% of patients.
Maltese: Newtropenja ta' grad 3/4 kienet osservata fi 43.8% tal-pazjenti.
English: Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Maltese: Kategorija farmakoterapewtika: aġenti neoplastiċi, vinka alkalojdi u analogi, Kodiċi ATC:
English: Uncommon Acute respiratory distress syndrome
Maltese: Mhux komuni Sindromu ta' għeja respiratorja akuta
English: When infused through a peripheral vein, vinflunine can induce venous irritation (see section 4.4).
Maltese: Meta infużat minn vina periferali, vinflunine jista' jikkaġuna irritazzjoni ġol-vina (ara sezzjoni 4.4).
English: A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).
Maltese: Interazzjoni possibbli ma' paklitaksel u doċetaksel (CYP3 substrati) ġiet issuġġerita minn studju in vitro (inibizzjoni ħafifa tal-metaboliżmu ta' vinflunine).
English: A pharmacokinetic phase I study was performed in 2 groups of patients with renal impairment classified according to the calculated creatinine clearance (CrCl) values: group 1 (n=13 patients) with moderate impairment (40 mL/min ≤ CrCl ≤ 60 mL/min) and group 2 (n=20 patients) with severe impairment (20 mL/min ≤ CrCl < 40 mL/min).
Maltese: Studju farmakokinetiku ta' fażi I sar f'żewġ gruppi ta'pazjenti b'indeboliment renali ikklassifikati skont il-valuri kkalkulati tat-tneħħija tal-krejatinine (CrCl): grupp 1 (n= 13-il pazjent) b'indeboliment moderat (40 mL/min ≤ CrCl ≤ 60 mL/min) u grupp 2 (n=20 pazjent) b'indeboliment sever (20 mL/min ≤ CrCl < 40 mL/min).
English: Vinflunine is moderately bound to human plasma proteins (67.2±1.1%) with a ratio between plasma and whole blood concentrations of 0.80±0.12.
Maltese: Distribuzzjoni Vinflunine hu moderatament marbut mal-proteini tal-plażma umani (67.2±1.1%) b'proportzjon bejn il plażma u l-konċentrazzjonijiet sħaħ ta' 0.80±0.12.
English: Tabulated list of adverse reactions
Maltese: Lista tabulta ta' reazzjonijiet avversi
English: Renal impairment
Maltese: Falliment renali
English: Infections and infestations Common Neutropenic infection Infections (viral, bacterial, fungal) Uncommon Neutropenic sepsis
Maltese: Infezzjoni newtropeniku Infezzjonijiet (virali, batterjali, fungali)
English: Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Maltese: Grad ≥ 3 Stitikezza seħħet f'15.3% tal-pazjenti kkurati.
English: General precautions for preparation and administration.
Maltese: Prekawzjonijiet ġenerali għall-preparazzjoni u għall-amministrazzjoni.
English: Febrile neutropenia defined as ANC < 1,000/mm3and fever ≥ 38.5°C of unknown origin without clinically microbiologically documented infection (NCI CTC version 2.0) was observed in 5.2% of patients.
Maltese: < 1,000/mm3 u deni ≥ 38.5°C ta' oriġini mhux magħrufa mingħajr infezzjoni mikrobijoloġika klinikament dokumentata (NCI CTC verżjoni 2.0) kienet osservata f'5.2% tal-pazjenti.
English: For detailed instructions on administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dettaljati dwar l-amministrazzjoni, ara sezzjoni 6.6.
English: In clinical studies, patients with CrCl (creatinine clearance) > 60 mL/min were included and treated at the recommended dose.
Maltese: Fi studji kliniċi, pazjenti b'CrCl (kreatinine clearance)> 60 mL/min kienu inklużi u kkurati bid-doża rakkomandata.
English: Pharmacokinetics of vinflunine was not modified for patients 70 ≤ age < 75 years and 75 ≤ age < 80 years.
Maltese: Il-farmakokinetiċi ta' VFL ma nbidlux għal pazjenti ta' 70 ≤ età < 75 sena u 75 ≤ età < 80 sena.
English: Baseline ANC < 1,500/mm3 for the first administration, baseline ANC < 1,000/mm3 for subsequent administrations (see section 4.4).
Maltese: Linja tal-bażi ANC < 1,500/mm3 għall-ewwel amministrazzjoni, linja tal-bażi ANC < 1,000/mm3 għal amministrazzjonijiet sussegwenti (ara sezzjoni 4.4). Plejtlits < 100,000/mm3 (ara sezzjoni 4.4).
English: Frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: Reazzjonijiet avversi huma mniżżlin f'lista hawn taħt mill-Klassi tas-Sistema tal-Organu, frekwenza u grad ta' severità (NCI CTC verżjoni 2.0). Frekwenza ta' reazzjonijiet avversi huma definiti bl-użu talkonvenzjoni kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1,000,< 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Maltese: Il-proċeduri tattrasferimenti kollha jeħtieġu adeżjoni stretta ma' tekniċi mhux settiċi, preferibbilment li jimpjegaw kappun tas-sigurtà għal-fluss vertikali tal-lamin.
English: When infused through a peripheral vein, vinflunine can induce Grade 1 (22% of the patients, 14.1% of the cycles), Grade 2 (11.0% of the patients, 6.8% of the cycles) or Grade 3 (0.8% of the patients, 0.2% of the cycles) venous irritation.
Maltese: 1% taċċikli), Grad 2 (11.0% tal-pazjenti, 6.8% taċ-ċikli) jew Grad 3 (0.8% tal-pazjenti, 0.2% taċ-ċikli)
English: Uncommon Visual disturbance
Maltese: Disturbi fil-vista
English: Vinflunine pharmacokinetics was not modified in those patients, however based on hepatic biologic parameter modifications following vinflunine administration (gamma glutamyl transferases (GGT), transaminases, bilirubin), the dose recommendations are as follows:
Maltese: Il-farmakokinetiċi tal-vinflunine ma ġiex immodifikat f'dawk ilpazjenti, madankollu bbażata fuq modifikazzjonijiet ta' parametri epatiċi bijoloġiċi wara l amministrazzjoni tal-vinflunine (gamma glutamyl transferasi (GGT), transaminasi, bilirubin), irrakkomandazzjonijiet tad-dożi huma kif ġejjin:
English: Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
Maltese: Grad 2 hu definit bħala “moderat”, Grad 3 bħala “serju” u Grad 4 bħala “theddida għall ħajja” (ara Lista 2 fis-sezzjoni 4.2).
English: Other medicines and Javlor
Maltese: Mediċini oħra u Javlor
English: Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients.
Maltese: Infezzjoni b'newtropenja ta' Grad 3/4 kienet osservata fi 2.8% tal-pazjenti.
English: Grade 3 was experienced by 0.6% patients.
Maltese: Grad 3 kienet mġarrba minn 0.6% tal-pazjenti.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Maltese: Dispnea seħħet f'3.2% tal-pazjenti imma rari kienet severa (Grad 3/4: 1.2%).
English: Constipation is managed by medical care (see section 4.4).
Maltese: L-istitikezza titmexxa mill-assistenza medika (ara sezzjoni 4.4).
English: Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine.
Maltese: Newtropenja, lewkopenja, anemija u tromboċitopenja huma reazzjonijiet avversa frekwenti ta' vinflunine.
English: Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
Maltese: B'kollox 8 pazjenti (0.6% tal-popolazzjoni kkurata) mietu kawża ta' infezzjoni bħala komplikazzjoni li seħħet waqt newtropenja.
English: A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively.
Maltese: Studju f'fażi I evalwa l-effett tal-kura ketokonażol (inibitur CYP3A4 potenti) fuq farmakokinetiċi talvinflunine indikaw li l-ko-amministrazzjoni ta' ketokonażol (400 mg orali darba kuljum għal tmint ijiem) irriżulta f'30% u 50% żieda f'espożizzjonijiet tad-demm lejn vinflunine u l-metabolit tiegħu 4Odeaċetilvinflunine DVFL, rispettivament.
English: Table 1: Dose delay for subsequent cycles due to toxicity
Maltese: Tabella 1: Dewmien tad-doża għall-ċikli sussegwenti minħabba tossiċità Tossiċità
English: A pharmacokinetic interaction between vinflunine and pegylated/liposomal doxorubicin was observed, resulting in a 15% to 30% apparent increase in vinflunine exposure and a 2 to 3-fold apparent decrease of doxorubicin AUC, whereas for doxorubicinol, the concentrations of the metabolite were not affected.
Maltese: Interazzjoni farmakokinetika bejn vinflunine u doksorubiċin peġilat/liposomali ġiet osservata, u tirriżulta f'żieda apparenti ta'15% sa 30% ta' espożizzjoni tal-vinflunine u tnaqqis apparenti ta' doksorubiċin AUC minn 2 sa 3 darbiet, filwaqt li għal doksorubiċinol, il-konċentrazzjonijiet talmetabolit ma kinux affettwati.
English: One 2 mL vial contains 50 mg of vinflunine (as ditartrate) One 4 mL vial contains 100 mg of vinflunine (as ditartrate) One 10 mL vial contains 250 mg of vinflunine (as ditartrate)
Maltese: Kull kunjett fih jew 2 mL (50 mg vinflunine), 4 mL (100 mg vinflunine) u 10 mL (250 mg vinflunine) ta' konċentrat għas-soluzzjoni għall-infużjoni.
English: Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C) Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
Maltese: Newtropenja bid-deni (ANC < 1,000/mm3 u deni ≥ 38,5°C) Grad ta' Mukosite jew Stitikezza 2 ≥ 5 ijiem jew Grad ≥ 3 kull tul ta' żmien1
English: - with a prothrombin time > 70% NV (Normal Value) and presenting at least one of the following criteria: [ ULN (Upper Limit of Normal) < bilirubin ≤ 1.5×ULN and/or 1.5xULN < transaminases ≤ 2.5×ULN and/or ULN < GGT ≤ 5×ULN ].
Maltese: - Ma hemm bżonn ta' ebda aġġustament fid-doża f'pazjenti - b'ħin prothrombin > 70% NV (Valur Normali) u li jippreżentaw għallinqas wieħed mill kriterji li ġejjin [ ULN (Limitu ta' Fuq tan-Normal) < bilirubin ≤ 1.5×ULN u/jew 1.5xULN < transaminasi ≤ 2.5×ULN u/jew ULN < GGT ≤ 5×ULN ],
English: Javlor 25 mg/mL sterile concentrate vinflunine
Maltese: U MNEJN GĦANDU JINGĦATA Javlor 25 mg/mL konċentrat sterili vinflunine
English: Uncommon Odynophagia Gastric disorders Oesophagitis
Maltese: Odinofaġia Disturbi Gastriċi Esofaġite Disturbi ġenġivali
English: • The Javlor solution for infusion should be infused over 20 minutes.
Maltese: • Is-soluzzjoni għall-infużjoni Javlor għandha tkun infużata għal aktar minn 20 minuta.
English: Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Maltese: Grad 3 rimettar bħala ≥ 6 episodji fi 24 siegħa fuq pretrattament; jew bżonn ta' fluwidi ġol-vini.
English: Nevertheless, vinflunine should be used with caution in patients with increase of the proarrhythmic risk (e.g. congestive heart failure, known history of QT interval prolongation, hypokalaemia) (see section 4.8).
Maltese: Madankollu, vinflunine għandu jintuża b'attenzjoni f'pazjenti b'żieda ta' riskju proarritmiku (eż insuffiċjenza konġestiva tal-qalb, storja magħrufa ta' dewmien fl intervall QT, hipokalemija) (ara sezzjoni 4.8).
English: The doses recommended in patients of at least 75 years old are as follows: - in patients of at least 75 years old but less than 80 years, the dose of vinflunine to be given is 280 mg/m² every 3 weeks.
Maltese: Id-dożi rakkomandati f'pazjenti ta' mill-inqas 75 sena huma kif ġej: - f'pazjenti ta' mill-inqas 75 sena iżda iżgħar minn 80 sena, id-doża ta' vinflunine li għandha tingħata hija ta' 280 mg/m² kull 3 ġimgħat.
English: Either peripheral lines or a central catheter can be used for vinflunine administration.
Maltese: Linji periferali jew kateter ċentrali jistgħu jintużaw għall-amministrazzjoni tal-vinflunine.
English: Hypersensitivity to the active substance or other vinca alkaloids.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew vinka alkalojdi oħrajn.
English: Therefore the concomitant use of vinflunine and potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole and grapefruit juice) or inducers (such as rifampicin and Hypericum perforatum (St John's wort)) should be avoided since they may increase or decrease vinflunine and DVFL concentrations (see section 4.4 and 5.2).
Maltese: B'hekk l-użu konkomitanti ma' vinflunine ta' inibituri CYP3A4 potenti (bħal ritonavir, ketokonażol u itrakonażol u meraq tal-grejpfrut) jew stimulanti (bħal rifampiċin u Hypericum perforatum (St John's wort)) għandhom ikunu evitati minħabba li jistgħu iżidu jew inaqqsu l-konċentrazzjonijiet tal vinflunine u DVFL (ara sezzjoni 4.4 u 5.2).
English: Content of the pack and other information What Javlor contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Javlor
English: The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Maltese: L-użu konkomitanti ta' inibituri potenti jew stimulanti potenti ta' CYP3A4 bil-vinflunine għandu jiġi evitat (ara sezzjoni 4.5).
English: - chills, excessive sweating - allergy, dehydration, headache, skin rash, itching - digestive problems, pain in the mouth, on the tongue and toothache, taste alteration - muscular weakness, pain in jaw, pain in extremity, back pain, pain in joints, muscular pain, bone pain, ear pain - dizziness, insomnia, transiant loss of consciousness - difficulties with body movements - fast heartbeat, raised blood pressure, reduced blood pressure - breathing difficulties, cough, chest pain - swelling of your arms, hands, feet, ankles, legs or other parts of your body - inflammation of the veins (phlebitis).
Maltese: - rjiħat, għaraq eċċessiv, - allerġija, deidrazzjoni, uġigħ ta' ras, raxx, ħakk, - problemi diġestivi, uġigħ ġol-ħalq, fuq l-ilsien u uġigħ fis-snien, tibdil fit-togħma, - dgħjufija fil-muskoli, uġigħ fix-xedaq, uġigħ f'estremitajiet, uġigħ fid-dahar, uġigħ fil-ġogi, uġigħ muskolari, uġigħ f'għadam, uġigħ fil-widnejn,
English: The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4).
Maltese: L-użu konkomitani ta' vinflunine ma' prodotti mediċinali oħrajn li idewmu l-intervall QT/QTc għandu jiġi evitat (ara sezzjoni 4.4).
English: The median overall survival was 6.9 months (vinflunine + BSC) vs. 4.6 months (BSC), but the difference did not reach statistical significance; hazard ratio 0.88 (95% CI 0.69, 1.12).
Maltese: Is-sopravivenza medjana fuq kollha bl-intenzjoni li tikkura (ITT) popolazzjoni kienet 6.9 xhur (vinflunine + BSC) kontra 4.6 xhur (BSC); imma d-differenza ma laħħqitx sinifikat statistiku; proporzjon ta' riskju 0.88 (95% CI 0.69, 1.12).
English: No modification of vinflunine and DVFL pharmacokinetics was observed in 25 patients presenting varying degrees of hepatic impairment, compared to patients with normal hepatic function.
Maltese: Indeboliment epatiku L-ebda modifikazzjoni tal-farmakokinetiċi tal-vinflunine u DVFL ma kienu osservati fil-25 pazjent li ppreżentaw gradi varji ta' indeboliment epatiku, meta kkumparat ma' pazjenti b'funzjoni epatika normali.
English: Organ toxicity: moderate, severe or life threatening
Maltese: Tossiċità fl-organi: moderata, serja jew ta' theddida għall-ħajja
English: Recommended co-medication
Maltese: TAL-PRODOTT MEDIĊINALI
English: Special attention is recommended when vinflunine is administered to patients with prior history of myocardial infarction/ischaemia or angina pectoris (see section 4.8).
Maltese: infart mijokardijaku/iskemija jew anġina pettoris (ara sezzjoni 4.8).
English: Common Rash Urticaria
Maltese: Raxx Urtikarja
English: Pharyngolaryngeal pain
Maltese: Uġigħ faringolarinġi
English: - The recommended dose of vinflunine is 200 mg/m² given once every 3 weeks in patients with moderate liver impairment (Child-Pugh grade B) or in patients with a prothrombin time ≥ 50% NV and bilirubin > 3×ULN and transaminases > ULN and GGT > ULN.
Maltese: - Id-doża rakkomandata ta' vinflunine hi 200mg/m² mogħtija darba kull 3 ġimgħat f'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh grad B) jew f'pazjenti b'ħin protrombin ≥ 50% NV u bilirubin > 3×ULN u transaminases > ULN u GGT > ULN,
English: Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Maltese: Ir-rabta ma' l-aċidu glikoproteina alfa-1 u mal plejtlits hi negliġibbli (< 5%).
English: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France
Maltese: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Franza
English: Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne France
Maltese: Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne Franza
English: In the subgroup analyses of prior cisplatin use versus BSC for progression free survival (PFS), the results were: HR (95% CI) = [0.55 (0.34 - 0.89); p=0.0129] in the absence of prior cisplatin, and a HR (95% CI) = [0.64 (0.48 - 0.85); p=0.0040] in the presence of prior cisplatin.
Maltese: HR (95% CI) = [0.55 (0.34 - 0.89); p=0.0129] in the absence of prior ċisplatin, u HR (95% CI) = [0.64 (0.48 - 0.85); p=0.0040] fl'assenza ta' ċisplastin preċedenti.
English: Instructions for administration should be followed as described in section 6.6.
Maltese: Istruzzjonijiet għall-amministrazzjoni għandha tkun segwita kif deskritt f'sezzjoni 6.6.
English: For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3.
Maltese: Għall-amministrazzjonijiet sussegwenti, vinflunine hu kontraindikat f'suġġetti b' linja ta' bażi ANC < 1,000/mm3 jew plejtlits <100,000/mm3.
English: A statistically significant difference on overall survival (p=0.040) was also seen in the eligible population (which excluded 13 patients with clinically significant protocol violations at baseline who were not eligible for treatment); hazard ratio 0.78 (95% CI 0.61, 0.99).
Maltese: Differenza statistikament sinifikattiva fuq is-sopravivenza totali (p=0.040) dehret fil-popolazzjoni eliġibbli (li jeskludi 13-il pazjent b'vjolazzjonijiet ta' protokoll klinikament sinifikanti fuq il-linja ta bażi li ma kienux eliġibbli għall-kura); proporzjon ta' riskju 0.78 (95% CI 0.61,0.99).
English: Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Maltese: Ileus grad 3/4 irraportata f'1.9% tal-pazjenti kienet riversibbli meta tmexxiet millassistenza medika.
English: Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3.
Maltese: L-introduzzjoni ta' vinflunine huwa kontraindikat f'suġġetti b'linja ta' bażi ANC < 1,500/mm3 jew plejtlits <100,000/mm3.
English: Glucose 50 mg/mL (5%) solution for infusion may also be used.
Maltese: Glukosju 50 mg/mL (5%) soluzzjoni għall-infużjoni jista' wkoll jintuża.
English: Severe hyponatraemia, including cases due to syndrome of inappropriate antidiuretic hormone secretion (SIADH), has been observed with the use of vinflunine (see section 4.8).
Maltese: Iponatremija severa, li tinkludi każijiet minħabba s-sindrome ta' tnixxija mhux kif suppost tal-ormon antidijuretiku (SIADH), ġiet osservata bl-użu ta' vinflunine (ara sezzjoni 4.8).
English: Intrathecal administration of Javlor may be fatal.
Maltese: L-għoti ta' Javlor ġot-teka jista' jkun fatali.
English: Tinnitus
Maltese: Ileus
English: Vomiting
Maltese: Vinflunine
English: Frequency Adverse Reactions
Maltese: Reazzjoniijiet Avversi
English: This is further confirmed by the population pharmacokinetic analysis (56 patients with CrCl between 20 mL/min and 60 mL/min), showing that vinflunine clearance is influenced by the creatinine clearance value (Cockcroft and Gault formula).
Maltese: Din hi ikkomfermata aktar mill-analiżi farmakokinetika tal-popolazzjoni (56 pazjent b'CrCl bejn 20 mL/min u 60 mL/min), li juru li ttneħħija tal-vinflunine hi nfuwenzata bil-valur tat-tneħħija tal-kreatinine (Formula Cockcroft u Gault).
English: Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Maltese: Newtropenja Grad 4 (ANC< 500/mm3)> 7 ijiem280 mg/m²
English: Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Maltese: Każijiet rari ta' Sindromu ta' Enċefalopatija Posterjuri Riversibbli kienu rapportati (ara sezzjoni 4.4).
English: Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Maltese: Id-doża rakkomandata hi 320 mg/m² ta' vinflunine f'infużjoni ġol-vina ta' 20 minuta kull 3 ġimgħat.
English: Vinflunine has shown to be clastogenic (induces chromosome breakage) in the in vivo micronucleus test in rat as well as mutagenic and clastogenic in a mouse lymphoma assay (without metabolic activation).
Maltese: Vinflunine wera li hu klastoġeniku (jikkaġuna ksur kromosomali) fl-eżami in vivo multinukleo fil-far kif ukoll mutaġeniku u klastoġeniku fl-analiżi ta' limfoma fil-ġrieden (mingħajr attivazzjoni metabolika).
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jista' jolqot minn 1 sa 10 persuni)