FrancophonIA/ELRC3.0 huggingface dataset:
English: Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush
Maltese: Trombożi fl-arterja ilijaka, xokk ipovolemiku, trombożi tar-riġel/driegħ arterjali, trombożi, fwawar, , trombożi venuża tal-ġenbejn, tromboflebite, flebite, flebite superfiċjali, pressjoni ortostatika baxxa, ematoma, iperemja, fwawar sħan
English: Hyperhydration (forced diuresis) should be administered according to the cisplatin SmPC to reduce the risk of renal toxicity associated with cisplatin therapy.
Maltese: Iperidrazzjoni (dijuresi sforzata) għandha tingħata skont l-SmPC ta' cisplatin sabiex jitnaqqas ir-riskju ta' tossiċità tal-kliewi marbuta ma' terapija b'cisplatin.
English: Palmar-plantar erythrodysaesthesia syndrome, rash, skin hyperpigmentation, dry skin, pruritus, alopecia,
Maltese: Eritrodisetesja ta' palmer-plantar, raxx, iperpigmentazzjo ni tal-ġilda, sindromu ta' ġilda xotta, ħakk, alopeċja,
English: Teysuno is an oral fluoropyrimidine anti-cancer medicinal product.
Maltese: mediċini oħra bbażati fuq fluoropyrimidine bħal dak ta' kontra l-moffa flucytosine.
English: Contents of the pack and other information What Teysuno contains - The active substances are tegafur, gimeracil and oteracil.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Teysuno - Is-sustanzi attivi huma tegafur, gimeracil u oteracil.
English: Dose reduction 2 (mg/m2)
Maltese: Tnaqqis fid-doża 2 (mg/m2)
English: How to store Teysuno
Maltese: Dożi ta' Teysuno
English: Adverse reactions of Grade 3 or higher such as increased blood creatinine, decreased creatinine clearance, toxic nephropathy, and acute renal failure have all been reported in patients receiving Teysuno in combination with cisplatin (see section 4.8).
Maltese: Reazzjonijiet avversi ta' Grad 3 jew ogħla bħal żieda tal-kreatinina fid-demm, tnaqqis fit-tneħħija ta' kreatinina, nefropatija tossika, u falliment renali akut lkoll ġew rapportati f'pazjenti li qed jieħdu Teysuno flimkien ma' cisplatin (ara sezzjoni 4.8).
English: Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
Maltese: Teysuno huwa indikat għal adulti -fit-trattament ta' kanċer tal-istonku avvanżat meta jingħata flimkien ma' cisplatin (ara sezzjoni 5.1).
English: Mean AUC0-inf and Cmax for 5-FU were approximately 3-fold greater following administration of Teysuno (50 mg expressed as tegafur content) than following administration of tegafur alone (800 mg), while AUC0-inf and Cmax values for the 5-FU metabolite α-fluoro-β-alanine (FBAL) were approximately 15- to 22-fold lower following administration of Teysuno than following administration of tegafur.
Maltese: L-AUC medju0-inf u Cmax għal 5-FU kienu madwar 3 darbiet aktar wara l-għoti ta' Teysuno (50 mg imfisser bħala kontenut ta' tegafur) milli t-teħid ta' tegafur waħdu (800 mg), waqt il-valuri ta' AUC0-inf u Cmax għall-metabolit tal-5-FU αfluoro-β-alanine (FBAL) kien ta' madwar 15- sa 22 darba inqas wara t-teħid ta' Teysuno milli għat-teħid ta' tegafur.
English: In vitro evaluation using primary cultures of human hepatocytes indicated that tegafur (0.7-70 µM), gimeracil (0.2-25 µM) and oteracil (0.04-4 µM) had little or no inductive effect on CYP1A2, CYP2B6 or CYP3A4/5 metabolic activities.
Maltese: 04-4 µM) ftit li xejn kellhom effett jew xejn affattu fuq lattivitajiet metaboliċi fuq CYP1A2, CYP2B6 jew CYP3A4/5.
English: Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg oteracil (as monopotassium).
Maltese: Kull kapsula iebsa fiha 15 mg tegafur, 4.35 mg gimeracil, u 11.8 mg oteracil (bħala monopotassium).
English: CLINICAL PARTICULARS
Maltese: KOMPOŻIZZJONI KWALITTATIVA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg oteracil (as salt).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula ibsa fiha 20 mg tegafur, 5.8 mg gimeracil and 15.
English: The safety profile of Teysuno in a post-marketing safety surveillance study in Japan of 4,177 patients treated with Teysuno for advanced gastric cancer was generally similar to that seen with this regimen and in the Japanese registration studies (i.e., major toxicities were leukocytopaenia, anorexia, and nausea/vomiting).
Maltese: Il-profil ta' sigurtà ta' Teysuno fi studju ta' sorvelljanza dwar is-sigurtà wara t-tqegħid fis-suq fil-Ġappun fuq 4,177 pazjent ikkurat b'Teysuno għal kanċer tal-istonku avvanzat kien ġeneralment bħal dak li deher f'dan il-programm ta' kura u fl-istudji ta' reġistrazzjoni Ġappuniża (i.e., tossiċitajiet maġġuri kienu lewkoċitopenja, anoreksja, u dardir/remettar).
English: Mean 5-FU maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) values were approximately 3-fold higher after Teysuno administration than after administration of tegafur alone, despite a 16-fold lower Teysuno dose (50 mg of tegafur) compared to tegafur alone (800 mg), and are attributed to inhibition of DPD by gimeracil.
Maltese: Il-konċentrazzjoni massima medja ta' 5-FU fil-plażma (Il-valuri ta' Cmax) u l-erja taħt il-kurva ta' konċentrazzjoni-ħin (AUC) kienu madwar 3 darbiet ogħla wara t-teħid ta' Teysuno meta mqabbel mat-teħid ta' tegafur waħdu, minkejja doża 16-il darba aktar baxxa ta' Teysuno (50 mg ta' tegafur) meta mqabbla ma' tegafur waħdu (800 mg), u huma attribwiti għall-impediment ta' DPD b'gimeracil.
English: Teysuno was not found to be mutagenic when tested in the in vitro Ames assay.
Maltese: Teysuno ma nstabx li hu mutaġeniku meta ġie ttestjat in vitro fl-assaġġ ta' Ames.
English: Renal function, as reflected by creatinine clearance, was the primary factor that influenced gimeracil exposure and 5-FU exposure.
Maltese: Il-funzjoni tal-kliewi, kif murija bit-tneħħija ta' kreatinina, kien il-fattur prinċipali li influwenza l-espożizzjoni għal gimeracil u l-espożizzjoni għal 5-FU.
English: Consistent with the lower CYP2A6 activity in the Asian patients, tegafur AUC0-12 was higher and T1/2 was longer in the Asian group compared to the Caucasian group.
Maltese: Konsistenti mal-inqas attività ta' CYP2A6 f'pazjenti Ażjatiċi, lAUC ta' tegafur0-12 kien ogħla u T1/2 kien itwal fil-grupp Ażjatiku meta mqabbel mal-grupp Kawkasi.
English: Despite the lack of DLTs in the last cohort, the dose of cisplatin was not elevated beyond 75 mg/m2.
Maltese: Minkejja n-nuqqas ta' DLTs fl-aħħar koorti, id-doża ta' cisplatin ma ġietx elevata lil hinn minn 75 mg/m2.
English: Refer to “Dose modifications for special populations / Renal impairment for guidance.”
Maltese: Irreferi għal,” Modifikazzjonijiet fid-doża għal popolazzjonijiet speċjali /Indeboliment tal-kliewi”.
English: Other oral fluorpyrimidines
Maltese: Fluoropyrimidines orali oħrajn
English: Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
Maltese: Kura marbuta mat-trażżin tal-mudullu, li tinkludi newtropenija, lewkopenija, tromboċitopenija, anemija u panċitopenija, ġiet rapportata fost pazjenti kkurati b'Teysuno flimkien ma' cisplatin.
English: In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
Maltese: Fi studju Ġappuniż ta' Fażi I li utilizza 5 gruppi ta' dożaġġ b'dożi li jvarjaw minn 25 sa 200 mg/korp, kien hemm żieda proporzjonali għad-doża fl-espożizzjoni għal tegafur, gimeracil u oteracil.
English: Teysuno capsules are usually taken for 21 days followed by a 7 day rest period (when no capsules are taken).
Maltese: Il-kapsuli ta' Teysuno ġeneralment jittieħdu għal 21 jum segwiti minn perijodu ta' mistrieħ ta' 7 ijiem (meta l-ebda kapsula ma ttieħed).
English: The capsule has an opaque white body and opaque white cap imprinted “TC442” in grey.
Maltese: Il-kapsula għandha korp abjad opak u kappa opaka bajda li fuqha hemm stampat “TC442” bil-griż.
English: Tel: +39 (0)2 241 26710/26711 info@nordicpharma.it
Maltese: Nordic Pharma Tel: +39 (0)2 753 2629 info@nordicpharma.it
English: Female
Maltese: Ġenerali
English: The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Maltese: Il-farmakokinetiċi (PK) b'doża waħda u multipla ta' Teysuno f'kombinazzjoni ma' cisplatin kienu evalwati fi tliet studji.
English: Administration of Teysuno under fed conditions resulted in decreased AUC0-inf for oteracil of approximately 71% and gimeracil of approximately 25% relative to fasting administration.
Maltese: It-teħid ta' Teysuno fuq l-ikel irriżulta fi tnaqqis fl-AUC0-inf għal oteracil ta' madwar 71% u ta' gimeracil ta' madwar 25% mata mqabbel mat-teħid marbut mas-sawm.
English: Gastro-oesophageal junction Both
Maltese: Issospendi l-kura sal-Grad 0 jew 1
English: The protein binding in human serum was not concentration-dependent over a range of 0.1 to 1.0 µg/ml for oteracil, gimeracil, and 5-FU and 1.2 to 11.8 µg/ml for tegafur.
Maltese: Ir-rabta ma' proteini fis-serum tal-bniedem ma kienx jiddependi fuq il-konċentrazzjoni fuq il-medda ta' bejn 0.1 sa 1.0 µg/ml għal oteracil, gimeracil, u 5-FU u 1.2 sa 11.8 µg/ml għal tegafur.
English: Administration of Teysuno in hepatitis B virus carriers, HBc antigen negative and HBc antibody positive patients, or HBs antigen negative and HBs antibody positive patients may result in reactivation of hepatitis B.
Maltese: L-għoti ta' Teysuno lil portaturi tal-virus ta' epatite B, pazjenti li rriżultaw negattiv għall-antiġen ta' HBc u pożittivi għal antikorp HBc, jew pazjenti negattivi għall-antiġen HBs u pożittivi għall-antikorp ta' HBs, jista' jirriżulta f'riattivazzjoni ta' epatite B.
English: Nordic Pharma
Maltese: Luxembourg/Luxemburg Nordic Pharma
English: In this study, 521 patients were randomised to treatment with Teysuno (25 mg/m2 orally twice daily for 21 days followed by a 7-day rest period) and cisplatin (75 mg/m2 intravenous infusion once every 4 weeks); and 508 patients were randomised to treatment with 5-FU (1000 mg/m2/24 hours as a continuous intravenous infusion on Days 1 through 5 repeated every 4 weeks) and cisplatin (100 mg/m2 as an intravenous infusion on Day 1 repeated every 4 weeks).
Maltese: pazjenti ġew magħżula b'mod każwali għal kura b'5-FU (1000 mg/m-2/24 siegħa bħala infużjoni ġolvina kontinwa minn f'Jum 1 sa 5 ripetut kull 4 ġimgħat) u cisplatin (100 mg/m2 bħala infużjoni ġol vina f'Jum 1 ripetuta kull 4 ġimgħat).
English: The increase in 5-FU exposure in patients with mild renal impairment in this study together with the results of simulation in the population pharmacokinetic analysis suggest that a Teysuno dose of 25 mg/m2 twice daily in patients with mild renal impairment could achieve 5-FU plasma concentrations similar to those obtained in patients with normal renal function receiving 30 mg/m2 twice daily as monotherapy and also those with moderate renal impairment receiving 20 mg/m2 twice daily.
Maltese: Iż-żieda fl-espożizzjoni ta' 5-FU f'pazjenti b'indeboliment ħafif tal-kliewi f'dan l-istudju flimkien mar-riżultati ta' stimulazzjoni fl-analiżi farmakokinetika tal-popolazzjoni jissuġerixxu li ddoża ta' Teysuno ta' 25 mg/m2 darbtejn kuljum f'pazjenti b'indeboliment tal-kliewi ħafif jistgħu jiksbu konċentrazzjonijiet fil-plażma ta' 5-FU simili għal dawk miksuba f'pazjenti b'funzjoni tal-kliewi normali li qed jieħdu 30 mg/m2 darbtejn kuljum bħala monoterapija u wkoll dawk b'indeboliment tal-kliewi moderat li qed jieħdu 20 mg/m2 darbtejn kuljum.
English: 30 to 49 ml/min Start treatment at one reduced dose level
Maltese: 30 sa 49 ml/min Ibda l-kura b'livell wieħed ta' doża mnaqqsa
English: Total daily dose in mga
Maltese: Doża totali ta' kuljum f'mga
English: 5-FU is metabolised by the liver enzyme DPD.
Maltese: Dan il-prodott mediċinali fih lactose.
English: In a dose escalation study comparing the tolerability of 5-FU in Teysuno and tegafur + gimeracil (no oteracil), the 25 mg/m2 dose level could not be attained in the absence of oteracil due to the occurrence of dose limiting toxicities (Grade 3 diarrhoea in 2 patients, and cardio-respiratory arrest in 1 patient) in the tegafur+gimeracil arm.
Maltese: Fi studju b'doża dejjem tikber li qabbel it-tollerabilità ta' 5-FU f'Teysuno u tegafur + gimeracil (mingħajr oteracil), il-livell tad-doża ta' 25 mg/m2 ma setax jintlaħaq fin-nuqqas ta' oteracil minħabba t-tossiċitajiet li bdew jillimitaw id-doża (dijarea ta' Grad 3 f'2 pazkenti, u arrest kardjorespiratorju f'pazjent wieħed) fil-parti tal-istudju ta' tegafur+gimeracil.
English: Using plasma uracil concentrations to assess DPD activity in clinical studies, no marked changes in plasma uracil concentrations were observed after administration of a single 800 mg dose of tegafur while plasma uracil concentrations increased markedly after administration of a single 50 mg dose of Teysuno (reflecting DPD inhibition by gimeracil).
Maltese: Permezz ta' konċentrazzjonijiet ta' uracil fil-plażma sabiex tiġi assessjata l-attività ta' DPD fi studji kliniċi, l-ebda bidliet notevoli f'konċentrazzjonijiet ta' uracil fil-plażma ma ġew osservati wara l-għoti ta' doża waħda ta' 800 mg ta' tegafur filwaqt li konċentrazzjonijiet ta' uracil fil-plażma żdiedu b'mod notevoli wara doża waħda ta' 50 mg ta' Teysuno (li jirrifletti impediment ta' DPD b'gimeracil).
English: Bone marrow suppression
Maltese: Mard tal-pulmun interstizzjali
English: Number of capsules for each dose (2 doses/day)
Maltese: Għadd ta' kapsuli f'kull doża (2 dożi/jum)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Siq Nordic Group B.V.
English: Teysuno dose
Maltese: Tqala u treddigħ
English: Patients with low white blood cell counts should be monitored carefully for infection and risk of other complications of neutropaenia and treated as medically indicated (e.g., with antibiotics, granulocyte-colony stimulating factor [G-CSF]).
Maltese: Pazjenti li għandhom għadd baxx ta' ċelluli tad-demm bojod għandhom jiġu monitorati b'attenzjoni għal infezzjonijiet u r-riskju ta' komplikazzjonijiet ta' newtropenija, u kkurati kif indikat b'mod mediku (eż., b'antibijotiċi, fattur li jistimula r-razza ta' granuloċiti [G-CSF]).
English: For the primary endpoint of overall survival, Teysuno in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin (see Table 9).
Maltese: Għall-ewwel punt aħħari ta' riferiment għal sopravivenza globali, Teysuno f'kombinazzjoni ma' cisplatin ma kienx inferjuri għal 5-FU f'kombinazzjoni ma' cisplatin (ara Tabella 9).
English: Tumour haemorrhage, cancer pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Maltese: Il-kontenut tal-kapsuli
English: There is therefore a high risk for developmental toxicity at clinical doses, primarily due to tegafur (5-FU) and to oteracil to a lesser extent.
Maltese: Għalhekk, hemm riskju għoli ta' tossiċità tal-iżvilupp f'dożi kliniċi, prinċipalment dovuti għal tegafur (5-FU) u għal oteracil fuq firxa inqas.
English: • Severe renal impairment (CrCl below 30 ml/min) Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Maltese: darbtejn kuljum f'pazjenti b'funzjoni tal-kliewi normali (ara sezzjoni 5.2), l-għoti ta' Teysuno mhux rakkomandat minħabba l-inċidenza possibilment ogħla ta' każijiet avversi marbuta ma' disturbi fid-demm u s-sistema limfatika għajr meta l-benefiċċji jisbqu b'mod ċar ir-riskji (ara sezzjonijiet 4.4 u 4.8).
English: Ear and labyrinth disorders
Maltese: Disturbi talwidnejn u tassistema labirintika
English: Grade 1 Any occurrence
Maltese: Grad 1 Kull każ
English: - are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines - have known genetic deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) - are pregnant or breast-feeding - have severe blood disorders - have kidney disease requiring dialysis - are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Maltese: jew kellek reazzjonijiet severi jew mhux mistennija bi fluoropyrimidines - għandek nuqqas ġenetiku tal-enzima dihydropyrimidine dehydrogenase (DPD) - inti tqila jew qed tredda' - jekk kellek disturbi tad-demm severi - jekk għandek mard tal-kliewi li jeħtieġ id-dijalisi - jekk qed tiġi ttrattat issa jew kont ittrattat fl-aħħar 4 ġimgħat bi brivudine bħala parti minn terapija għal herpes zoster (ġidri r-riħ jew ħruq ta' Sant'Antnin).
English: After single dose administration, there was a statistically significant decrease in 5-FU and gimeracil Cmax for the severe hepatic impairment group relative to that of the normal group, but this difference was not observed after multiple dose administration.
Maltese: Wara t-teħid ta' doża waħda, kien hemm tnaqqis statistikament sinifikanti fl-5-FU u gimeracil Cmax għall-grupp b'indeboliment tal-fwied sever meta mqabbel mal-grupp normali, imma din id-differenza ma kinetx osservata wara l-għoti ta' doża multipla.
English: Teysuno belongs to the fluoropyrimidine class of medicines known as “antineoplastic agents” which stop the growth of cancer cells.
Maltese: Saru tmintax-il studju farmakokinetiku addizzjonali bl-użu tal-programm ta' kura rilevanti bħala monoterapija.
English: PCTFE/PVC/Al opaque blisters containing 14 capsules each.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji opaki ta' PCTFE/PVC/Al li fihom 14-il kapsula kull waħda.
English: Common side effects (may affect 1 to 10 in 100 people) include:
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw minn persuna 1 sa 10 f'100) jinkludu:
English: Patients treated with Teysuno in combination with cisplatin should be closely monitored and laboratory tests, including haematology, liver function, renal function, and serum electrolytes, should be performed frequently.
Maltese: Pazjenti li jingħataw il-kura b'Teysuno flimkien ma' cisplatin għandhom jiġu sorveljati mill-qrib u testijiet tal-laboratorju li jinkludu ematoloġija, funzjoni tal-fwied, funzjoni tal-kliewi u elettroliti fis-serum, għandhom isiru ta' spiss.
English: Exfoliative rash, skin exfoliation, necrolytic migratory erythema, blood blister, dermatitis allergic, skin reaction, dermatitis acneiform, erythema, increased tendency to bruise, purpura, hyperhidrosis, night sweats, nail atrophy, pigmentation disorder, skin discoloration, hypertrichosis
Maltese: Raxx li jqaxxar, tqaxxir tal-ġilda, eritema migratorja nekrolitika, nfafet bid-demm, dermatite allerġika, reazzjoni tal-ġilda, dermatite akneiform, eritema tendenza ogħla biex titbenġel, purpura, iperidrosi, għaraq bil-lejl, atropija taddwiefer, disturb fil-pigmentazzjoni, tibdil fil-kulur tal-ġilda, ipertrikossi.
English: Teysuno was clastogenic in vitro using Chinese hamster lung cells and was weakly clastogenic in vivo in mouse bone marrow.
Maltese: Teysuno kien klastoġeniku in vitro permezz taċ-ċelluli pulmonari tal-ħemster Ċiniż u kien klastoġeniku b'mod ħafif in vivo fil-mudullun tal-ġurdien.
English: In this study, 7 patients with moderate renal impairment were treated with 20 mg/m2 Teysuno twice daily, while 7 patients with severe renal impairment received Teysuno 20 mg/m2 once daily.
Maltese: F'dan l-istudju, 7 pazjenti b'indeboliment moderat tal-kliewi kienu kkurati b'20 mg/m2 Teysuno, darbtejn kuljum, filwaqt li 7 pazjenti b'indeboliment renali sever ħadu 20 mg/m2
English: The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Maltese: Il-konċentrazzjoni ta' uracil fil-plażma kienetġiet lura fil-livelli bażi ta' riferiment wara 48 siegħa wara li tingħata d-doża, li jindika r-riversibilità tal-impediment ta' DPD b'gimeracil.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt).
Maltese: Kull kapsula ibsa fiha 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (bħala melħ).
English: Vision disorder, lacrimal disorder, conjunctivitis, corneal disorder b
Maltese: Disturbi fil-vista, disturbi fid-dmugħ, disturb fl-għajnejn, konġuntivite, Disturb kornealib
English: Renal failure, blood creatinine increased, glomerular filtration rate decreased, blood urea increased
Maltese: Falliment tal-kliewi, żieda fil-kreatinina fiddemm, tnaqqis fir-rata ta' filtrazzjoni glomerulari, żieda fl-urea ddemm
English: Neoplasms benign, malignant and unspecified (incl.
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (Inklużi ċesti u polipi)
English: Toxic nephropathy, oligouria, haematuria, renal impairment, pollakiuria, blood creatine increased, blood creatinine decreased
Maltese: Nefropatija tossika, oligourja, ematurja, indeboliment renali, , pollakijurija, żieda fil-kreatinina fid-demm, tnaqqis ta' kreatinina fid-demm
English: There are no clinical data on the distribution of radiolabeled components of Teysuno.
Maltese: Mhemmx tagħrif kliniku fuq id-distribuzzjoni ta' komponenti radjutikkettati ta' Teysuno.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Maltese: Tagħrif farmakodinamiku/tossikoloġiku disponibbli fl-annimali wera li Teysuno u l-metaboliti tiegħu jiġu eliminati fil-ħalib (għal dettalji ara sezzjoni 5.3).
English: - acute liver failure - pancreas infection - muscle breakdown - loss of sense of smell - sun allergy - widespread blood clotting and bleeding - disease affecting the white matter of the brain - serious illness with blistering of the skin, mouth and genitals recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)
Maltese: - falliment tal-fwied akut - infezzjoni fil-frixa - il-muskoli jċedu - telf fix-xamm - allerġija għax-xemx - emboli tad-demm u emorraġiji mifruxa - mard li jaffettwa l-materja l-bajda tal-moħħ - mard serju b'infafet fuq il-ġilda, il-ħalq u l-ġenitali - rikorrenza (riattivazzjoni) tal-infezzjoni tal-epatite B meta diġà kellek epatite B fil-passat
English: The only Grade 3 or higher adverse reaction was reduced visual acuity.
Maltese: L-unika reazzjoni avversa ta' Grad 3 jew ogħla kienet it-tnaqqis fl-akuwità viżwali.
English: In the Phase III (FLAGS) study, tegafur AUC was significantly higher in patients with the CYP2A6*4 allele, however, no significant difference was found for 5-FU AUC and for the incidence of adverse reactions.
Maltese: III (FLAGS), l-AUC ta' tegafur kien sinifikament ogħla f'pazjenti bl-allele CYP2A6*4, madanakollu, ebda differenza sinifikanti ma nstabet għal AUC ta' 5FU u għall-inċidenza ta' reazzjonijiet avversi.
English: Cisplatin a Expressed as tegafur content.
Maltese: Kif jidher Teysuno u l-kontenut tal-pakkett
English: Following both single dose (50 mg) and multiple dose (30 mg/m2 twice daily) administration of Teysuno in man, maximum uracil concentrations reflecting DPD inhibition were observed approximately 4 hours postdose.
Maltese: Wara l-għoti ta' doża waħda (50 mg) u doża multipla (30 mg/m2 darbtejn kuljum) l-għoti ta' Teysuno fil bniedem, konċentrazzjonijiet massimi ta' uracil li jirrifletti l-impediment ta' DPD kienu osservati madwar 4 sigħat wara d-doża.
English: Teysuno has not been studied in gastric cancer patients with MSI.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM