natgillin/translations-raw huggingface dataset:
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 14 marts, 2011 Dato for seneste fornyelse: 19 november, 2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Svimmelhed, hovedpine, dysgeusi
Dizziness, headache, dysgeusia
KI = konfidensinterval, fuldt analysesæt = alle randomiserede, behandlede patienter analyseret som efter tildelt behandling (primær analysepopulation)
Overall Survival Intent-to-treat Full analysis set Progression-free Survival Full analysis set CI = confidence interval; Full analysis set = all randomised, treated patients analysed as allocated (primary analysis population)
Der skal være en periode på mindst 4 uger mellem endt behandling med brivudin og initiering af behandling med Teysuno.
There must be at least a 4-week waiting period between end of treatment with brivudine and start of Teysuno therapy.
Samlet dagsdosis i mga
Total daily dose in mga
I dette forsøg blev 7 patienter med moderat nedsat nyrefunktion behandlet med 20 mg/m2 Teysuno to gange dagligt, mens 7 patienter med svært nedsat nyrefunktion fik Teysuno 20 mg/m2 én gang dagligt.
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.
Første dosisreduktiona: til 20 mg/m2 BSA ≥ 2,13 m2
First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Hvis en eller flere af bivirkningerne bliver alvorlige, skal du holde op med at tage Teysuno og fortælle det til lægen med det samme.
If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Dosisændring af Teysuno på grund af toksicitet, når lægemidlet anvendes i kombination med cisplatin, kan udføres på to måder.
Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Minimumskriterierne for genoptagelse af Teysuno-behandlingen er anført i tabel 6.
For minimum criteria for resumption of Teysuno treatment, see Table 6.
En sammenligning af sikkerheden mellem 71 patienter ≥70 år (ældre) og 450 patienter <70 år, der blev behandlet med Teysuno i kombination med cisplatin i FLAGS forsøget, påviste, at forekomsten af alle bivirkninger af grad 3 eller værre (62 % vs. 52 %), alle alvorlige bivirkninger (30 % vs. 19 %) og frekvensen af udtrædelse før tid på grund af bivirkninger af både Teysuno og cisplatin (21 % vs. 12 %) lod til at være højere blandt patienter ≥70 år.
Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients <70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old.
Efter en enkeltdosis Teysuno varierede T1/2-værdier fra 6,7 til 11,3 timer for tegafur, fra 3,1 til 4,1 timer for gimeracil og fra 1,8 til 9,5 timer for oteracil.
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.
Den farmakokinetiske profil af 5-FU var den samme både med og uden oteracil.
The 5-FU pharmacokinetic profile was similar in the presence and absence of oteracil.
Eftersom CYP2A6 er det enzym, der er ansvarligt for omdannelse af tegafur til 5-FU, bør samtidig indgift af en kendt CYP2A6-hæmmer og Teysuno undgås, da Teysunos virkning kan blive nedsat (se pkt.
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).
Tabel 1: Tilladte standard doser og dosisreduktioner for Teysuno og/eller cisplatin
Table 1: Standard dose and dose reductions allowed for Teysuno and/or for cisplatin
DPD-inducere
DPD inducers
Den anbefalede sædvanlige dosis Teysuno givet i kombination med cisplatin er 25 mg/m2 (udtrykt som tegafurindhold) to gange dagligt, morgen og aften, i 21 konsekutive dage efterfulgt af 7 dages pause (1 behandlingsforløb).
The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m2 (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle).
Der er ikke udført forsøg med Teysuno alene eller i kombination med cisplatin hos pædiatriske patienter.
No studies have been performed with Teysuno alone or in combination with cisplatin in paediatric patients.
Proteinbinding i humant serum var ikke afhængigt af koncentration over et interval på 0,1 til 1,0 µg/ml for oteracil, gimeracil og 5-FU og 1,2 til 11,8 µg/ml for tegafur.
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.
Dosisjustering af Teysuno for næste dosis/i næste behandlingsforløb
Teysuno dose adjustment for next dose / next cycle
Hvis du holder op med at tage Teysuno
If you stop taking Teysuno
In-vitro-evaluering med humane levermikrosomer tydede på, at hverken tegafur, gimeracil eller oteracil viste nogen relevant hæmmende virkning på enzymaktiviteten af de cytokrom P450 isoformer, der blev testet (dvs. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4).
In vitro evaluation using human liver microsomes indicated that neither tegafur, gimeracil nor oteracil showed any relevant inhibitory effects on enzyme activities of the cytochrome P450 isoforms tested (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4).
Niveauer af tegafur, gimeracil, oteracil og 5-FU var kvantificerbare i 10 timer efter dosis.
Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Hypotension, dyb venetrombose, hypertension
Hypotension, deep vein thrombosis, hypertension
Den vigtigste metaboliske vej for tegafur er gennem konvertering til 5-FU via CYP2A6 i leveren, hvor gimeracil var stabil i humant leverhomogenat (S9 fraktion) med adenosin 3'-phosphat 5'-phosphosulphate lithiumsalt (PAPS, en kofaktor for sulfotransferase) eller nicotinamid adenin dinucleotid phosphat (NADPH).
The main metabolic pathway for tegafur is through conversion to 5-FU via CYP2A6 in the liver, whereas gimeracil was stable in human liver homogenate (S9 fraction) with adenosine 3'-phosphate 5'-phosphosulfphate lithium salt (PAPS; a co-factor for sulfotransferase) or nicotinamide adenine dinucleotide phosphate (NADPH).
Efter en enkeltdosis Teysuno blev ca. 3,8 % til 4,2 % af indgivet tegafur, 65 % til 72 % af indgivet gimeracil og 3,5 % til 3,9 % af indgivet oteracil udskilt uændret i urinen.
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.
Gimeracil påvirkede ikke renal clearance af tegafur, FBAL og 5-FU efter indgift af Teysuno i sammenligning med clearance efter indgift af tegafur alene.
There was no effect of gimeracil on renal clearance of tegafur, FBAL, and 5-FU following administration of Teysuno as compared to their clearance following administration of tegafur alone.
Tredje forekomst
Third occurrence
Termen perifer neuropati omfatter følgende indberettede bivirkninger: perifer sensorisk neuropati, paræstesi, hypæstesi, perifer neuropati, polyneuropati, neurotoksicitet og dysæstesi.
The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Tabel 2: Beregning af standard og reducerede doser efter legemsoverflade (m2)
Table 2: Standard and reduced dose calculations by body surface area (m2)
Samtidig indgift af andre fluoropyrimidiner såsom capecitabin, 5-FU, tegafur eller flucytosin kan medføre additiv toksicitet, og er derfor kontraindiceret.
Co-administration of other fluoropyrimidines such as capecitabine, 5-FU, tegafur, or flucytosine can lead to additive toxicities, and is contraindicated.
Teysuno ordineres af læger til behandling af voksne med fremskreden mavekræft (ventrikelcancer) og tages sammen med cisplatin, et andet lægemiddel mod cancer.
Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine.
Anden dosisreduktiona: til 15 mg/m2 BSA ≥ 2,17 m2
Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Teysuno indeholder de aktive stoffer tegafur, gimeracil og oteracil.
Teysuno contains the active substances tegafur gimeracil and oteracil.
Teysuno er ikke blevet undersøgt hos patienter med ventrikelcancer og MSI.
Teysuno has not been studied in gastric cancer patients with MSI.
Toksicitetsforsøg med gentagen dosering hos rotter, hunde og aber producerede ændringer, der typisk associeres med indgift af et anti-cancer lægemiddel, der fremkalder cytotoksiske virkninger på populationer med hurtigt delende celler, såsom anæmi, reduktion i immun- og fordøjelsessystemets funktion, afbrydelse af spermatogenese og atrofi af forplantningsorganerne hos hanner og hunner.
Repeat-dose toxicity studies in rats, dogs and monkeys produced changes typically associated with administration of an anti-cancer medicinal product eliciting cytotoxic effects on populations of rapidly dividing cells, such as anaemia, decrease in the immune and digestive system function, disruption of spermatogenesis, and atrophy in male and female reproductive organs.
Hyppigheden af bivirkninger i blod- og lymfesystem på tværs af alle cykler var 28,6 % og 44,4 % hos patienter med hhv. moderat og svær nyreinsufficiens.
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.
Folinat/folinsyre
Folinate/folinic acid
Hvis du har glemt at tage Teysuno
If you forget to take Teysuno
Der er ikke udført kliniske forsøg, der sammenligner Teysuno med andre orale 5-FU-forbindelser.
No clinical trials are available comparing Teysuno versus other oral 5-FU compounds.
Derfor bør Teysuno ikke indgives til børn eller unge under 18 år.
Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Der er indberettet central og perifer neuropati hos patienter i behandling med Teysuno i kombination med cisplatin.
Central and peripheral neuropathy has been reported in patients treated with Teysuno in combination with cisplatin.
Der foreligger farmakodynamiske/toksikologiske data om dyr, der viser, at Teysuno eller dets metabolitter udskilles i mælk (der er yderligere oplysninger under pkt.
Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Sammenhængen mellem følsomhed for 5-FU og MSI hos patienter med ventrikelcancer er uklar, og sammenhængen mellem Teysuno og MSI ved ventrikelcancer kendes ikke.
The association between 5-FU sensitivity and MSI in patients with gastric cancer is unclear and the association between Teysuno and MSI in gastric cancer is unknown.
Brivudin må ikke administreres samtidig med Teysuno.
Brivudine must not be administered concomitantly with Teysuno.
Sædvanlig dosisa: 25 mg/m2
Standard dosea: 25 mg/m2
Gimeracil øger eksponeringen af 5-fluorouracil (5-FU) ved at hæmme DPD, det primære enzym ved metabolisering af 5-FU.
Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU.
Gimeracil hæmmer metabolismen af 5-FU ved reversibelt og selektivt at hæmme DPD, det primære metaboliske enzym for 5-FU, så højere plasmakoncentrationer af 5-FU kan opnås med indgift af en lavere dosis tegafur.
Gimeracil inhibits the metabolism of 5-FU by reversibly and selectively inhibiting DPD, the primary metabolic enzyme for 5-FU, so that higher plasma concentrations of 5-FU are achieved with the administration of a lower dose of tegafur.
Patienter i ambulant behandling bør få udleveret recept på både antiemetika og lægemidler mod diarré.
Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Behandlingsrelateret knoglemarvssuppression, inklusive neutropeni, leukopeni, trombocytopeni, anæmi og pancytopeni, er indberettet for patienter, der er blevet behandlet med Teysuno i kombination med cisplatin.
Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
• Kontraindikationer for cisplatin.
• Contraindications for cisplatin; refer to the cisplatin SmPC.
I dette forsøg blev 521 patienter randomiseret til behandling med Teysuno (25 mg/m2 peroralt to gange dagligt i 21 dage efterfulgt af en hvileperiode på 7 dage) og cisplatin (75 mg/m2 intravenøs infusion en gang hver 4. uge), og 508 patienter blev randomiseret til behandling med 5-FU (1000 mg/m2/døgn som kontinuerlig intravenøs infusion på dag 1 til og med 5, gentaget hver 4. uge) og cisplatin (100 mg/m2 som intravenøs infusion på dag 1,
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).
De sædvanlige og reducerede doser af Teysuno og cisplatin samt beregninger i forhold til legemsoverflade (BSA - Body Surface Area) for doser af Teysuno givet i kombination med cisplatin er anført i hhv. tabel 1 og 2.
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.
Vertigo, tilstoppet øre, ubehag i øret
Vertigo, ear congestion, ear discomfort
Teysuno-kapslerne skal synkes med vand mindst 1 time inden eller 1 time efter et måltid.
Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal.
In-vitro-evaluering med primære dyrkninger af humane hepatocytter tydede på, at tegafur (0,770 µM), gimeracil (0,2-25 µM) og oteracil (0,04-4 µM) kun havde ringe eller ingen virkning på den metaboliske aktivitet af CYP1A2, CYP2B6 og CYP3A4/5.
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.
Hos mennesker var den umiddelbare terminale eliminationshalveringstid (T1/2) af 5-FU, der blev observeret efter indgift af Teysuno (indeholdende tegafur, et 5-FU pro-drug) længere (ca. 1,6-1,9 timer) end den, der tidligere var indberettet efter intravenøs indgift af 5-FU (10 til 20 minutter).
In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Børn og unge Teysuno anbefales ikke til børn under 18 år.
Children and adolescents Teysuno is not recommended for children under 18 years of age.
Andre kliniske forsøg med Teysuno i kombination med cisplatin
Other clinical studies with Teysuno in combination with cisplatin
Kvinder i den fertile alder skal tilrådes at undgå graviditet, mens de er i behandling med dette lægemiddel.
Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with this medicinal product.
Behandlingen med Teysuno kan fortsættes efter, at behandlingen med cisplatin er stoppet.
Teysuno can be continued after stopping cisplatin.
Sjældne bivirkninger (kan forekomme hos 1 til 10 ud af 10.000 personer) og meget sjældne bivirkninger (kan forekomme hos færre end 1 ud af 10.000 personer) omfatter:
Rare side effects (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people) include:
Hver hård kapsel indeholder 70,2 mg lactosemonohydrat.
Each hard capsule contains 70.2 mg lactose monohydrate.
Samtidig indgift kan imidlertid reducere clearance og dermed øge plasmaniveauerne af 5-FU.
However, co-administration may decrease clearance and, thus increase plasma levels of 5-FU.
Traumer, forgiftninger og behandlingsko mplikationer:
Injury, poisoning and procedural complications
Stigningen i eksponeringen for 5-FU hos patienter med mildt nedsat nyrefunktion i dette forsøg sammen med resultaterne af simulation i den farmakokinetiske populationsanalyse tyder på, at en Teysuno-dosis på 25 mg/m2 to gange dagligt hos patienter med mildt nedsat nyrefunktion kunne opnå plasmakoncentrationer af 5-FU, der var den samme som hos patienter med normal nyrefunktion, der fik 30 mg/m2 to gange dagligt som monoterapi, og også som hos patienter med moderat nedsat nyrefunktion, der fik 20 mg/m2 to gange dagligt.
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.
Hver hård kapsel indeholder 93,6 mg lactosemonohydrat.
Each hard capsule contains 93.6 mg lactose monohydrate.
Forhydrering (forceret diurese) bør iværksættes ifølge produktresumeet til cisplatin for at mindske risikoen for nyretoksicitet i forbindelse med cisplatinbehandling.
Hyperhydration (forced diuresis) should be administered according to the cisplatin SmPC to reduce the risk of renal toxicity associated with cisplatin therapy.
Der blev udført et fase I-studie for at evaluere farmakokinetikken af de aktive stoffer i Teysuno og deres metabolitter hos cancerpatienter med nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
A Phase I study was conducted to evaluate the PK of the components of Teysuno and their metabolites in cancer patients with impaired renal function compared to those with normal renal function.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Teysuno, hvis du har: - en blodsygdom - en nyresygdom mave- og/eller tarmproblemer såsom smerter, diarré, opkastning eller dehydrering - en øjensygdom såsom tørre øjne eller øget tåreflåd en eksisterende eller tidligere infektion i leveren med hepatitis B-virus, da lægen så muligvis vil kontrollere dig nøjere
Warnings and precautionsTalk to your doctor before taking teysuno if you have: blood disorders kidney disease stomach and/or bowel problems such as pain, diarrhoea, vomiting and dehydration eye disorders, such as “dry eye” or increased tearing a current or previous infection of the liver with the hepatitis B virus, since your doctor may want to monitor you more closely
Det tilrådes at udvise forsigtighed, eftersom folinsyre vides at fremme aktiviteten af 5-FU.
Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Det er en fast dosiskombination af tre aktive stoffer: Tegafur - som efter absorption konverteres til anti-cancer stoffet 5-FU, gimeracilen DPD-hæmmer (dihydropyrimidin-dehydrogenase) som forebygger kroppens degradering af 5-FU, og oteracil - en OPRT-hæmmer (orotat phosphoribosyltransferase), der reducerer aktiviteten af 5-FU i normale gastrointestinale slimhinder.
It is a fixed dose combination of three active substances, tegafur, which after absorption is converted into the anti-cancer substance 5-FU; gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU by the body; and, oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa.
Der findes ingen tilgængelig data vedrørende administration af Teysuno til patienter med terminal, dialysekrævende nyreinsufficiens (se pkt.
No data is available regarding Teysuno administration in patients with end stage renal disease requiring dialysis (see section 4.3).
Ved at bruge plasmakoncentrationer af uracil til at vurdere DPD-aktiviteten i kliniske forsøg blev der ikke observeret markerede ændringer i plasmakoncentrationerne af uracil efter indgift af en enkelt dosis 800 mg tegafur, mens plasmakoncentrationerne af uracil øgedes markant efter indgift af en enkelt dosis 50 mg Teysuno (hvilket viser gimeracils hæmning af DPD).
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).
Plasmakoncentrationerne af uracil returnerede til baselineniveauer ca. 48 timer efter dosis, hvilket tyder på, at gimeracils hæmning af DPD reverseres.
The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Det tilrådes at udvise forsigtighed, eftersom samtidig indgift kan øge toksiciteten af Teysuno.
Caution is advised as co-administration may increase the toxicity of Teysuno.
Oteracil, gimeracil, 5-FU og tegafur var hhv. 8,4 %, 32,2 %, 18,4 % og 52,3 % proteinbundet.
Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
Hvis der observeres nedsat glomerulær filtrationshastighed, bør Teysuno- og/eller cisplatindosis justeres i henhold til tabel 4, og der bør initeres alle nødvendige støttende foranstaltninger (se pkt.
If deterioration of glomerular filtration rate is observed, Teysuno and/or cisplatin dose should be adjusted according to Table 4, and appropriate supportive measures taken (see section 4.2).
Hvis det er indiceret, bør phenytoindosis justeres ifølge produktresumeet til phenytoin.
If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Efter indgift af både enkeltdosis (50 mg) og flerdosis (30 mg/m2 to gange dagligt) af Teysuno hos mennesker blev maksimale uracilkoncentrationer observeret ca. 4 timer efter dosis, hvilket viser DPD-hæmningen.
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.
Hvis du har taget brivudin, skal du vente mindst 4 uger efter endt behandling med brivudin før du må starte behandling med Teysuno.
If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take Teysuno.
Andre fluoropyrimidiner
Other fluoropyrimidines
Behandling med Teysuno anbefales ikke til patienter med svært nedsat nyrefunktion pga. en mulig højere forekomst af bivirkninger i blod- og lymfesystemet og risiko for uventet højere eksponering for 5-FU som følge af fluktuationer i nyrefunktionen hos disse patienter, medmindre fordelene klart opvejer risiciene (se pkt.
Treatment with Teysuno is not recommended in patients with severe renal impairment due to possibly higher incidence of adverse events of the blood and lymphatic system and the possibility of unexpectedly higher exposure to 5-FU as a result of fluctuations in renal function in these patients, unless the benefits clearly outweigh the risks (see sections 4.2, 4.8 and 5.2).