FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Maltese: Ġiet deskritta interazzjoni klinikament sinifikanti bejn brivudine u fluoropyrimidines (eż. capecitabine, 5-Fluorouracil, tegafur), li tirriżulta mill-impediment ta' dihyrdropyrimidine dehydrogenase minn brivudine.
English: Respiratory, tThoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Following a single dose of Teysuno, T1/2 values ranged from 6.7 to 11.3 hours for tegafur, from 3.1 to 4.1 hours for gimeracil, and from 1.8 to 9.5 hours for oteracil.
Maltese: Wara doża waħda ta' Teysuno, valuri ta' T1/2 kienu jvarjaw minn 6.7 sa 11.3 sigħat għal tegafur, minn 3.1 sa 4.1 sigħat għal gimeracil, u minn 1.8 sa 9.5 sigħat għal oteracil.
English: Pulmonary embolism, respiratory tract haemorrhage, exertional dyspnoea, pharyngolaryngeal pain, rhinorrhoea, pharyngeal erythema, rhinitis allergic, dysphonia, productive cough, nasal congestion
Maltese: Emboliżmu pulmonari, emorraġija tal-passaġġ respiratorju, dispnea tal-isforz, uġigħ faringolaringeali, rinorrea, eritema faringeali, rinite allerġika, disfonja, sogħla produttiva, konġestjoni nażali.
English: Dose modifications for toxicity should be made according to Tables 1, 3, 4, and 5.
Maltese: Il-modifikazzjonijiet fid-doża minħabba tossiċtà trid isir skont Tabelli 1, 3, 4, u 5.
English: Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle
Maltese: Perforazzjoni gastrointestinali, esofaġite, infezzjoni gastrointestinali, ileju, sadd gastrointestinali, axxite, edema tax-xofftejn, spażmu esofaġeali, ulċera gastrika, mard ta' rifluss gastroesofageali, gastrite refluss, fibrosi retroperitoneali, disturb gastrointestinali, emorraġija anali, murliti, tnixxija eċċessiva ta' riq, tifwieq, disturb tal-glandola tar-riq, kejlite, erofaġja, glossodinja, uġigħ fil-ħalq, ,snien fraġli
English: Carnauba wax
Maltese: Xema' ta' Carnauba
English: • History of severe and unexpected reactions to fluoropyrimidine therapy.
Maltese: • Storja ta' reazzjonijiet severi u mhux mistennija għal terapija bi fluoropyrimidine.
English: The most common treatment-related ocular disorders among patients in studies in Europe/United States of America (EU/USA) treated with Teysuno in combination with cisplatin were lacrimal disorders (8.8%), including increased lacrimation, dry eye, and acquired dacryostenosis (see section 4.8).
Maltese: Id-disturbi okulari l-aktar komuni marbuta mal-kura fost pazjenti fi studji li saru fl-Ewropa/l-Istati Uniti (UE/USA) kkurati b'Teysuno flimkien ma' cisplatin kienu disturbi marbuta mad-dmugħ (8.8%), li jinkludu lakrimazzjoni, għajnejn xotti, u dakrijostenosi miksuba (ara sezzjoni 4.8).
English: Coumarin-derivative anticoagulant
Maltese: Antikoagulant derivat mill-kumarin
English: A Phase I study investigated the pharmacokinetics of Teysuno monotherapy in Asian (Chinese/Malay) and Caucasian (US) patients.
Maltese: Studju ta' Fażi I stħarreġ il-farmakokinetiċi ta' monoterapija ta' Teysuno f'pazjenti Ażjatiċi (Ċiniżi/Malażjani) u Kawkasi (US).
English: Puh/Tel: +358 (0)10 231 1040 info@nordicdrugs.fi
Maltese: +358 (0)10 231 1040 info@nordicdrugs.fi
English: Contusion, medication error a Adverse reactions in the Investigations system organ class (SOC) have been reallocated to clinically appropriate SOCs related to their target organ.
Maltese: Kontużjoni, żball tal-mediċina a Reazzjonijiet avversi li jinsabu taħt Investigazzjonijiet fis-sistema tal-klassifika tal-organi (SOC) ġew allokati mill-ġdid f'sistema ta' Klassifika ta' Organi marbuta mal-organu Relatat.
English: In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
Maltese: III ta' FLAGS ma deherx li kien hemm relazzjoni bejn l-AUC ta' 5-FU (driegħ ta' Teysuno/cisplatin) u l-konċentrazzjoni ta' 5-FU (driegħ ta' 5-FU/cisplatin) matul Ċiklu 1 u riżultati ta' effikaċja ta' sopravivenza globali (overall survival (OS)) jew sopravivenza mingħajr progressjoni (progression-free survival (PFS)).
English: Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl >80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Maltese: Il-paragun bejn 218-il pazjent b'indeboliment tal-kliewi ħafif bl-linja bażi ta' riferiment (CrCl 51 sa 80 ml/min) u 297 pazjent b'funzjoni tal-kliewi normali bl-linja bażi ta' riferiment (CrCl >80 ml/min) ittrattat b'Teysuno flimkien ma' cisplatin fl-istudju ta' FLAGS kien jindika li ma kienx hemm differenzi klinikament sinifikanti fis-sigurtà bejn pazjenti li kellhom indeboliment ħafif tal-kliewi u pazjenti b'funzjoni normali tal-kliewi.
English: Each dose reduction results in approximately 20-25% reduction of dose.
Maltese: Kull tnaqqis tad-doża jirriżulta f'madwar tnaqqis ta' 20-25% fid-doża.
English: The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with Teysuno-based therapy.
Maltese: Il-frekwenzi ta' reazzjonijiet avversi rari u rari ħafna relevanti għas-saħħa huma minn stħarriġ ta' sar wara t-tqegħid fis-suq fuq 866,000 pazjent fl-Ażja (ilmaġġoranza Ġappuniżi) li ġew ikkurati b'terapija bbażata fuq Teysuno.
English: This 28 day period is one treatment cycle.
Maltese: Il-perijodu ta' 28 jum huma ċiklu ta' kura waħda.
English: Central and peripheral neuropathy has been reported in patients treated with Teysuno in combination with cisplatin.
Maltese: In-newropatija ċentrali u periferali ġiet rapportata f'pazjenti trattati b'Teysuno flimkien ma' cisplatin.
English: However, metabolites of folinate/folinic acid will form a ternary structure with thymidylate synthase and fluorodeoxyuridine monophosphate (FdUMP), potentially increasing the cytotoxicity of 5-FU.
Maltese: Madanakollu, metaboliti ta' folinate/folinic acid ser jifformaw struttura ternarja b' thymidylate synthase u fluorodeoxyuridine monophosphate (FdUMP), li potenzjalment tista' żżid iċ-ċitotossiċità ta' 5-FU.
English: The use of coumarin-derivative anticoagulant in clinical trials has been associated with elevated INR and gastrointestinal bleeding, bleeding tendency, haematuria, and anaemia in patients receiving Teysuno therapy.
Maltese: L-użu ta' antikoagulanti derivat minn kumarin fi provi kliniċi ġie assoċjat ma' INR elevat u emorraġija gastrointestinali, tendenza ta' emorraġiji, ematurja, u anemija f'pazjenti li jirċievu t-terapija b'Teysuno.
English: Refer to the cisplatin SmPC for eye disorders observed with cisplatin therapy.
Maltese: Irreferi għall-SmPCta' cisplatin għal disturbi marbuta mal-għajnejn osservati b'terapija ta' cisplatin.
English: As CYP2A6 is the major enzyme responsible for the conversion of tegafur to 5-FU, co-administration of a known CYP2A6 inhibitor and Teysuno should be avoided as effectiveness of Teysuno could be decreased (see section 5.2).
Maltese: Peress li CYP2A6 hija l-enzima prinċipalment responsabbli għall-konverżjoni ta' tegafur għal 5-FU, l-għoti flimkien tal-impeditur magħruf ta' CYP2A6 u Teysuno għandu jiġi evitat peress li l-effettività ta' Teysuno tista' titnaqqas (ara sezzjoni 5.2).
English: The incidence of blood and lymphatic systems disorders adverse reactions observed across all cycles in the moderate and severe renal impairment patients were 28.6% and 44.4%, respectively.
Maltese: L-inċidenza ta' reazzjonijiet avversi marbuta ma' disturbi tad-demm u s-sistema limfatika osservati fiċ-ċikli kollha f'pazjenti b'indeboliment tal-kliewi moderat u sever kienu 28.6% u 44.4% rispettivament.
English: Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno.
Maltese: Cisplatin għandu jitwaqqaf wara 6 ċikli mingħajr ma jitwaqqaf Teysuno.
English: Gastrointestinal haemorrhage, stomatitis, gastrointestinal inflammation, flatulence, abdominal pain, dysphagia, abdominal discomfort, dyspepsia, dry mouth
Maltese: Uġigħ ta' żaqq, stomatite, infjammazzjoni gastrointestinali, emorraġija gastrointestinali, disfaġja, skonfort abdominali, dispepsja, gass, ħalq xott
English: • Moderate renal impairment (CrCl 30 to 50 ml/min) The recommended standard dose in patients with moderate renal impairment is 20 mg/m2 twice daily (expressed as tegafur content) (see sections 4.8 and 5.2).
Maltese: Id-doża standard rakkomandata f'pazjenti li għandhom indeboliment tal-kliewi moderat hi ta' 20 mg/m2 darbtejn kuljum (mfissra skont il-kontenut ta' tegafur) (ara sezzjonijiet 4.8 u 5.2).
English: Teysuno contains
Maltese: It-tielet każ
English: Following a single dose of Teysuno, approximately 3.8% to 4.2% of administered tegafur, 65% to 72% of administered gimeracil, and 3.5% to 3.9% of administered oteracil were excreted unchanged in the urine.
Maltese: Wara l-għoti ta' doża waħda ta' Teysuno, madwar 3.8% sa 4.2% ta' tegafur li ngħata, 65% sa 72% ta' gimeracil li ngħata, u 3.5% sa 3.9% ta' oteracil li ngħata kien eliminat mingħajr ma nbidlu fl-awrina.
English: Dyspnoea, epistaxis, hiccups, cough
Maltese: Dardir, remettar, dijarea, stitikezza
English: Titanium dioxide (E171) Sodium lauryl sulphate Talc
Maltese: Sodium lauryl sulphate
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.>
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno (see section 4.3 and 4.5).
Maltese: It-trattament bi brivudine jista' jibda 24 siegħa wara l-aħħar doża ta' Teysuno (ara sezzjonijiet 4.3 u 4.5).
English: Teysuno should only be given on Days 1 to 21 of each cycle, i.e., treatment should not be given on Days 22 to 28 of a cycle.
Maltese: Teysuno għandu jingħata fil-Jum 1 sa 21 ta' kull ċiklu, i.e., il-kura m'għandhiex tingħata filJum 22 sa 28 taċ-ċiklu.
English: The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
Maltese: Il-frekwenzi ta' reazzjonijiet avversi komuni ħafna, komuni, u mhux komuni huma minn 593 pazjent ikkurat b'Teysuno flimkien ma' cisplatin fi provi kliniċi.
English: Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication
Maltese: Aċċident ċerebrovaskulari, infart ċerebrali, disturb ċerebrovaskulari, konvulżjoni, puplesija iskemika, sinkope, emiparesi, afasja, atassja, enċefalopatija metabolika, nuqqas ta' konoxxenza, newrite akustika, indeboliment ta' memorja, disturbi filbilanċ, ħedla, rogħda, agewsja, parosmija, sensazzjoni ta' ħruq, formikazzjoni.
English: Studies in Japanese patients have suggested an effect of CYP2A6*4 polymorphism on Teysuno pharmacokinetics.
Maltese: Studji f'pazjenti Ġappuniżi ssuġġerew effett ta' polimorfiżmu ta' CYP2A6*4 fuq il-farmakokinetiċi ta' Teysuno.
English: In a Phase I Teysuno monotherapy study that investigated the pharmacokinetics of components and metabolites in patients with normal and impaired renal function, patients with mild renal impairment (CrCl 51 to 80 ml/min) receiving the same monotherapy dose of 30 mg/m2 twice daily (the maximum tolerated dose for monotherapy) as patients with normal renal function (CrCl >80 ml/min) had an increase in mean 5-FU AUC0-inf relative to that of the normal patients.
Maltese: Fi studju ta' Fażi 1 ta' monoterapija ta' Teysuno li stħarreġ il-farmakokinetiċi ta' komponenti u metaboliti f'pazjenti b'funzjoni tal-kliewi normali u indeboliti, pazjenti b'indeboliment tal-kliewi ħafif (CrCl 51 sa 80 ml/min) li qed jirċievu l-istess doża ta' monoterapija ta' 30 mg/m2 darbtejn kuljum
English: Dizziness, headache, dysgeusia
Maltese: Dispnea, epistassi, sulluzzu, sogħla
English: Haematologic
Maltese: Ematoloġiċi
English: Each pack contains 42 capsules or 84 capsules.
Maltese: Kull pakkett fih 42 kapsula jew 84 kapsula.
English: - Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Maltese: - Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna ta' barra u t-tikketta wara EXP.
English: The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Maltese: It-terminu newropatija periferali tinkludi r-reazzjonijiet avversi rapportati li ġejjin: newropatija sensorjali periferali, paraestesija, ipoestesija, newropatija periferali, polinewropatija, newrotossiċità u disestesija.
English: Calculated creatinine clearance ≥30 ml/mina Neutrophils ≥1.5 x 109/l
Maltese: Neutrofili ≥1.5 x 109/l
English: Capsule contents Lactose monohydrate Magnesium stearate
Maltese: Lactose monohydrate
English: Although no intravenous data are available for Teysuno in humans, the volume of distribution could be roughly estimated from the apparent volume of distribution and urinary excretion data as 16 l/m2, 17 l/m2, and 23 l/m2 for tegafur, gimeracil and oteracil, respectively.
Maltese: Għalkemm data dwar l-għoti fil-vina ta' Teysuno fil-bniedem mhux disponibbli, il-volum ta' distribuzzjoni jista' jiġi stmat bejn wieħed u ieħor mill-volum apparenti ta' distribuzzjoni u t-tagħrif dwar eliminazzjoni awrinarja bħala 16 l/m2, 17 l/m2, u 23 l/m2 għal tegafur, gimeracil u oteracil, rispettivament.
English: Erectile dysfunction, breast tenderness, nipple pain
Maltese: Disfunzjoni fl-erezzjoni, tenerezza fissider, uġigħ fil-beżżula tas-sider
English: Suomi/Finland Nordic Drugs
Maltese: België/Belgique/Belgien Nordic Pharma
English: Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 15.8 mg oteracil (as monopotassium).
Maltese: Kull kapsula iebsa fiha 20 mg tegafur, 5.8 mg gimeracil, u 15.8 mg oteracil (bħala monopotassium).
English: Detailed information this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettronika tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Patients receiving oral coumarin-derivative anticoagulant therapy must have their anticoagulant response (International Normalized Ratio for prothrombin time [INR] or prothrombin time [PT]) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Maltese: Pazjenti li qed jirċievu terapija antikoagulanti orali derivata minn kumarin għandhom ikollhom rrispons antikoagulanti tagħhom (Proporzjon Internazzjonali Normalizzat għal ħin ta' prothrombin [INR] jew ħin ta' prothrombin [PT]) immonitorat mill-qrib u d-doża antikoagulanti hekk aġġustata (ara sezzjoni 4.5).
English: The standard and reduced Teysuno and cisplatin doses and calculations according to body surface area (BSA) for doses of Teysuno given in combination with cisplatin are provided in Table 1 and Table 2, respectively.
Maltese: Id-dożi standard u mnaqqsa ta' Teysuno u cisplatin u kalkulazzjonijiet skont l-erja tas-superfiċje tal-ġisem (BSA) għal dożi ta' Teysuno li jingħataw f'kombinazzjoni ma' cisplatin huma pprovduti f'Tabella 1 u Tabella 2, rispettivament.
English: Toxicity gradesa
Maltese: Tossiċita okulari
English: Teysuno 15 mg/4.35 mg/11.8 mg hard capsules tegafur/gimeracil/oteracil
Maltese: Teysuno 15 mg/4.35 mg/11.8 mg kapsuli tegafur/gimeracil/oteracil
English: The combination of tegafur, gimeracil, and oteracil was set at 1:0.4:1 molar ratio as optimum in order to maintain 5-FU exposure and thus sustain anti-tumour activity while reducing toxicity associated with 5-FU alone.
Maltese: Il-kombinazzjoni ta' tegafur, gimeracil, u oteracil ġiet stabbilita f'1:0.4:1 bħala l-aħjar proporzjon molari sabiex tinżamm l-espożizzjoni ta' 5-FU u b'hekk tiġi sostnuta l-attività ta' kontra t-tumuri waqt li titnaqqas it-tossiċità marbuta ma' 5-FU waħdu.
English: Dose reduction 1 (mg/m2)
Maltese: Tnaqqis fid-doża 1 (mg/m2)
English: Printing ink
Maltese: Sopravivenza mingħajr
English: Discontinue treatment a According to the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0. b For Grade 2 nausea and/or vomiting, the anti-emetic therapy should be optimized prior to a suspension of Teysuno.
Maltese: Waqqaf il-kura a Skont il-Common Terminology Criteria for Adverse Events (CTCAE) tal-Programm tal-Evalwazzjoni tatTerapija tal-kanċer, l-Istitut Nazzjonali tal-Kanċer tal-Istati Uniti, verżjoni 3.0.
English: Uncommon side effects (may affect 1 to 10 in 1,000 people) include:
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw minn 1 sa 10 persuni f'1,000) jinkludu:
English: Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Maltese: Il-kawtela hija rakkomandata peress li folinic acid huwa magħruf li jħarrax l-attività ta' 5-FU.
English: Data from a multicentre, multinational (excluding Asia), randomised, controlled, open-label Phase III clinical study (FLAGS) support the use of Teysuno in combination with cisplatin for the treatment of patients with advanced gastric cancer.
Maltese: III, li kien multiċentrali, multinazzjonali (li jeskludi l-Ażja), bilkontrolli, randomised u open-label (FLAGS) issostni l-użu ta' Teysuno flimkien ma' cisplatin għallkura ta' pazjenti b'kanċer tal-istonku avvanzat.
English: After administration of a single dose of 50 mg Teysuno (expressed as tegafur content) in man (approximately 30 mg/m2 based on body surface area of 1.56 to 2.10 m2 for a typical patient; N=14),
Maltese: Wara t-teħid ta' doża waħda ta' 50 mg Teysuno (mfisser bħala kontenut ta' tegafur) fil-bniedem (madwar 30 mg/m2 skont l-erja tas-superfiċje tal-ġisem ta' bejn 1.56 sa 2.10 m2 għal pazjent tipiku;
English: Capsule shell Gelatin
Maltese: U KONTENUT Kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
Maltese: Teysuno 15 mg/4.35 mg/11.8 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg hard capsules
Maltese: Teysuno 20 mg/5.8 mg/15.8 mg kapsuli ibsin
English: Carriers of HBV who require treatment with Teysuno should be closely monitored for signs and symptoms of active HBV infection throughout therapy, and follow-up monitoring for hepatic function tests or viral markers are recommended.
Maltese: Portaturi ta' HBV li jeħtieġu trattament b'Teysuno għandhom jiġu monitorati mill-qrib għal sinjali u sintomi ta' infezzjoni attiva tal-HBV matul it-terapija kollha, u monitoraġġ ta' follow-up għal testijiet tal-funzjoni tal-fwied jew markaturi virali huwa rakkomandat.
English: The following headings are used to rank the adverse reactions by frequency: 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), and not known (cannot be estimated from the available data).
Maltese: It-titli li ġejjin jintużaw sabiex jiggradaw ir-reazzjonijiet avversi skont il-frekwenza: 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), rari ħafna (<1/10,000) u mhux magħrufa (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Teysuno dose modification criteria
Maltese: Ebda modifikazzjoni fid-doża
English: The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey.
Maltese: Il-kapsula għandha korp opak bajdani u kappa opaka kannella li fuqha hemm stampat “TC448” bil-griż.
English: Neutropenic sepsis, septic shock, sepsis, infection, pneumonia, bacteremia, respiratory tract infection, upper respiratory tract infection, pyelonephritis acute, urinary tract infection, pharyngitis, nasopharyngitis, rhinitis, tooth infection, candidiasis, oral herpes, paronychia, furuncle
Maltese: Sepsis newropeniku, xokk settiku, sepsis, pnewmonja, batteremja, infezzjoni fil-passaġġ respiratorju, infezzjoni fil-passaġġ respiratorju ta' fuq, pajelonefrite akuta, infezzjoni talpassaġġ awrinarju, faringite, nażofarinġite, rinite, infezzjoni tas-snien, kandidijasi, herpes orali, paronikja, infafaet
English: Treatment with Teysuno produced various skin effects in rat (keratosis of footpad and tail) and dog (skin crusts and erosions).
Maltese: Il-kura b'Teysuno ipproduċiet effetti diversi fuq il-ġilda fil-firien (keratosi ta' sieq u d-denb) u l-klieb (qxur fil-ġilda u tekil).
English: Luxembourg/Luxemburg Nordic Pharma Tél/Tel: +32 (0)3 820 5224 info@nordicpharma.be
Maltese: Tél/Tel: +32 (0)3 820 5224 info@nordicpharma.be
English: Leukoencephalopathy, anosmia
Maltese: Lewkoenċefalop atija, anosmija
English: Dehydration, hypokalaemia, hyponatraemia, hypocalcaemia, hypomagnesaemia, hypoalbuminaemia, hyperkalaemia
Maltese: Diżidrazzjoni, ipokalemija, iponatremija, ipokalċemija, ipomanesemija, ipoalbuminemija, iperkalemija
English: For minimum criteria for resumption of Teysuno treatment, see Table 6.
Maltese: Għal kriterji minimi sabiex terġa' tibda tingħata l-kura ta' Teysuno, ara Tabella 6.
English: Teysuno 20 mg/5.8 mg/15.8 mg hard capsules tegafur/gimeracil/oteracil
Maltese: Teysuno 20 mg/5.8 mg/15.8 mg kapsuli tegafur/gimeracil/oteracil
English: In addition, 5-fluorouridine-triphosphate (FUTP) is incorporated into RNA causing disruption of RNA functions.
Maltese: Barra minn hekk, 5-fluorouridine-triphosphate (FUTP) huwa inkorporat f'RNA u jikkaġuna sfrattu fil-funzjonijiet ta' RNA.
English: This treatment cycle is repeated every 4 weeks.
Maltese: Dan iċ-ċiklu ta' kura jiġi ripetut kull 4 ġimgħat.
English: - inhibitors of the enzyme CYP2A6 which activates Teysuno such as tranylcypromine and methoxsalen - folinic acid (often used in chemotherapy with methotrexate) - blood-thinning medicines: coumarin-derivative anticoagulants such as warfarin - medicines for the treatment of seizures or tremors such as phenytoin - medicines that treat gout such as allopurinol
Maltese: Teysuno ma jistax jiġi sostitwit għal mediċini oħra orali ta' fluoropyrimidine - impedituri tal-enzima CYP2A6 li tattiva Teysuno bħal tranylcypromine u methoxsalen - aċidu foliniku (li xi kultant jintuża fil-kimoterapija b'methotrexate) - mediċini li jraqqu d-demm: antikoagulanti derivattivi ta' kumarin bħal warfarina - mediċini għall-kura ta' puplesiji jew rogħda bħal phenytoin - mediċini li jikkuraw il-gotta bħal allopurinol
English: Patients with rare hereditory problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabasorption should not take this medicinal product.
Maltese: Intolleranza/assorbiment mhux tajjeb ta' glucose/galactose Dan il-prodott mediċinali fih lactose.