FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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).
English: Children and adolescents Teysuno is not recommended for children under 18 years of age.
Danish: Børn og unge Teysuno anbefales ikke til børn under 18 år.
English: Other clinical studies with Teysuno in combination with cisplatin
Danish: Andre kliniske forsøg med Teysuno i kombination med cisplatin
English: 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.
Danish: Kvinder i den fertile alder skal tilrådes at undgå graviditet, mens de er i behandling med dette lægemiddel.
English: Teysuno can be continued after stopping cisplatin.
Danish: Behandlingen med Teysuno kan fortsættes efter, at behandlingen med cisplatin er stoppet.
English: 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:
Danish: 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:
English: Each hard capsule contains 70.2 mg lactose monohydrate.
Danish: Hver hård kapsel indeholder 70,2 mg lactosemonohydrat.
English: However, co-administration may decrease clearance and, thus increase plasma levels of 5-FU.
Danish: Samtidig indgift kan imidlertid reducere clearance og dermed øge plasmaniveauerne af 5-FU.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingsko mplikationer:
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.
Danish: 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.
English: Each hard capsule contains 93.6 mg lactose monohydrate.
Danish: Hver hård kapsel indeholder 93,6 mg lactosemonohydrat.
English: Hyperhydration (forced diuresis) should be administered according to the cisplatin SmPC to reduce the risk of renal toxicity associated with cisplatin therapy.
Danish: Forhydrering (forceret diurese) bør iværksættes ifølge produktresumeet til cisplatin for at mindske risikoen for nyretoksicitet i forbindelse med cisplatinbehandling.
English: 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.
Danish: 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.
English: 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
Danish: 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
English: Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Danish: Det tilrådes at udvise forsigtighed, eftersom folinsyre vides at fremme aktiviteten af 5-FU.
English: 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.
Danish: 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.
English: No data is available regarding Teysuno administration in patients with end stage renal disease requiring dialysis (see section 4.3).
Danish: Der findes ingen tilgængelig data vedrørende administration af Teysuno til patienter med terminal, dialysekrævende nyreinsufficiens (se pkt.
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).
Danish: 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).
English: The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Danish: Plasmakoncentrationerne af uracil returnerede til baselineniveauer ca. 48 timer efter dosis, hvilket tyder på, at gimeracils hæmning af DPD reverseres.
English: Caution is advised as co-administration may increase the toxicity of Teysuno.
Danish: Det tilrådes at udvise forsigtighed, eftersom samtidig indgift kan øge toksiciteten af Teysuno.
English: Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
Danish: Oteracil, gimeracil, 5-FU og tegafur var hhv. 8,4 %, 32,2 %, 18,4 % og 52,3 % proteinbundet.
English: 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).
Danish: 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.
English: If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Danish: Hvis det er indiceret, bør phenytoindosis justeres ifølge produktresumeet til phenytoin.
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.
Danish: 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.
English: If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take Teysuno.
Danish: Hvis du har taget brivudin, skal du vente mindst 4 uger efter endt behandling med brivudin før du må starte behandling med Teysuno.
English: Other fluoropyrimidines
Danish: Andre fluoropyrimidiner
English: 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).
Danish: 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.
English: Do not take Teysuno if you: - are allergic to tegafur, gimeracil, oteracil or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Teysuno: - hvis du er allergisk over for tegafur, gimeracil, oteracil eller et af de øvrige indholdsstoffer i
English: Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition
Danish: Konfusion, rastløshed, personlighedsforstyrrelse, hallucination, depression, angst, nedsat libido, hæmmet seksualdrift
English: 5-FU is metabolised by the liver enzyme DPD.
Danish: 5-FU metaboliseres af leverenzymet DPD.
English: Hyperbilirubinaemia, alanine aminotransferase increased, aspartate aminotransferase increased
Danish: Hyperbilirubinæmi, øget alanin aminotransferase, øget aspartat aminotransferase
English: Detailed information this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Danish: Der er detaljerede oplysninger om dette lægemiddel på det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: Dose modifications for renal toxicities
Danish: Dosisændringer på grund af renale toksiciteter
English: Cisplatin dose modification at the start of the cycle of treatment
Danish: Dosisændring af cisplatin ved starten på et behandlingsforløb
English: Based on the results of in vitro studies, a part of oteracil is non-enzymatically degraded to 5-azauracil (5-AZU) by gastric fluid, and is then converted to cyanuric acid (CA) in the digestive tract.
Danish: Baseret på resultater af in-vitro forsøg degraderes en del af oteracil ikke-enzymatisk til 5-azauracil (5-AZU) af gastrisk væske og konverteres derefter til cyanurinsyre (CA) i mave-tarm-kanalen.
English: Following a reduced dose of Teysuno 20 mg/m2 administered once daily to the severe renal impairment group (CrCl < 30 ml/min), the single-dose AUC0-inf and multiple-dose AUC0-τ values for 5-FU were approximately 2-fold higher in the severe renal impairment group compared to those observed in the normal renal function group receiving 30 mg/m2 twice daily.
Danish: Efter en reduceret dosis Teysuno på 20 mg/m2 administreret én gang dagligt til gruppen med svært nedsat nyrefunktion (CrCl < 30 ml/min) var enkeltdosis-AUC0-inf- og flerdosis-AUC0-τ-værdier for 5FU ca. dobbelt så høje i gruppen med svært nedsat nyrefunktion sammenlignet med værdierne, der blev observeret i gruppen med normal nyrefunktion, der fik 30 mg/m2 to gange dagligt.
English: Maximum plasma uracil concentration was observed at 4 hours, with a return to baseline levels within approximately 48 hours after dosing, indicating the reversibility of the DPD inhibition by gimeracil.
Danish: Den maksimale plasmakoncentration af uracil blev observeret efter 4 timer, medens plasmakoncentrationerne faldt til baselineniveauet inden for ca. 48 timer efter dosering, hvilket indikerer reversibiliteten af gimeracils hæmning af DPD.
English: Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
Danish: Teysuno er indiceret hos voksne til behandling af fremskreden ventrikelcancer, når det gives sammen med cisplatin (se pkt.
English: The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Danish: Teysunos sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Administration of Teysuno with a meal reduced exposure to oteracil and gimeracil, with a more pronounced effect for oteracil than for gimeracil (see section 5.2).
Danish: Indgift af Teysuno samtidig med et måltid reducerede eksponering for oteracil og gimeracil, med en mere udtalt virkning for oteracil end for gimeracil (se pkt.
English: Teysuno dose changes within a 21-day treatment cycle
Danish: Dosisændringer af Teysuno i et 21-dages behandlingsforløb
English: A Phase I study established the current regimen by evaluating cohorts of Teysuno and cisplatin of 30 mg/m2 and 60 mg/m2 (dose-limiting toxicities [DLTs] seen were fatigue, and diarrhoea and dehydration); 25 mg/m2 and 60 mg/m2; and 25 mg/m2 and 75 mg/m2.
Danish: Et fase I-forsøg fastsatte det nuværende regime ved at evaluere kohorter af Teysuno og cisplatin på 30 mg/m2 og 60 mg/m2 (observerede dosisbegrænsende toksiciteter var træthed, diarré og dehydrering),; 25 mg/m2 og 60 mg/m2 samt 25 mg/m2 og 75 mg/m2.
English: • End stage renal disease patients requiring dialysis.
Danish: • Patienter med terminal, dialysekrævende nyreinsufficiens.
English: Refer to the cisplatin SmPC for eye disorders observed with cisplatin therapy.
Danish: Der henvises til produktresumeet til cisplatin vedrørende øjenlidelser, der er observeret med cisplatinbehandling.
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.
Danish: Der er beskrevet en klinisk signifikant interaktion mellem brivudin og fluorpyrimidiner (f.eks. capecitabin, 5-FU, tegafur), som et resultat af brivudins hæmning af dihydropyrimidindehydrogenase.
English: Endpoint Population
Danish: Endepunkt Population
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno (see section 4.3 and 4.5).
Danish: Behandling med brivudin kan initieres 24 timer efter sidste dosis af Teysuno (se pkt.
English: - Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Teysuno is contraindicated in pregnancy (see section 4.3).
Danish: Teysuno er kontraindiceret under graviditet (se pkt.
English: - Low platelet count leading to an increased chance of bleeding o If you have bleeding of the skin, mouth (caused by brushing teeth), nose, respiratory tract, stomach, gut, etc., stop taking Teysuno and contact your doctor immediately.
Danish: - Lavt antal blodplader, der medfører en øget blødningsrisiko o Hvis du bløder fra huden, munden (når du børster tænder), næsen, luftrøret, maven, tarmene osv., skal du holde op med at tage Teysuno og kontakte lægen med det samme.
English: However, nitromidazoles may reduce clearance of 5-FU and thus increase plasma levels of 5-FU.
Danish: Nitromidazoler kan reducere clearance af 5-FU og dermed øge plasmaniveauerne af 5-FU.
English: They are provided in blisters containing 14 capsules each.
Danish: De fås i blisterkort á 14 kapsler.
English: What you need to know before you take Teysuno
Danish: Det skal du vide, før du begynder at tage Teysuno
English: Manifestations of acute overdose reported include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation, bleeding, bone marrow depression, and respiratory failure.
Danish: Manifestationer, der er indberettet på akut overdosering, inkluderer kvalme, opkastning, diarré, mucositis, gastrointestinal irritation, blødning, knoglemarvsdepression og respirationssvigt.
English: doses, steady-state conditions are reached for tegafur, gimeracil, and oteracil at the latest by Day 8.
Danish: Efter indgift af 30 mg/m2 doser opnås steady-state for tegafur, gimeracil og oteracil senest på dag 8.
English: Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno.
Danish: Cisplatin bør seponeres efter 6 behandlingsforløb uden ophør af Teysuno.
English: • Lacrimal disorder includes adverse reactions of increased lacrimation, dry eye, and acquired dacryostenosis;
Danish: • Tårevejslidelser omfatter bivirkninger i form af øget tåresekretion, tørre øjne og erhvervet dacryostenose
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Der er detaljerede oplysninger om dette lægemiddel på det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Danish: Farmakokinetikken for enkelt- og flerdosis af Teysuno i kombination med cisplatin blev evalueret i tre forsøg.
English: LIST OF EXCIPIENTS Also contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Teysuno hårde kapsler indeholder også 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.
Danish: I et dosiseskalerende forsøg til sammenligning af tolerabiliteten af 5-FU ved behandling med Teysuno og tegafur + gimeracil (intet oteracil) kunne 25 mg/m2 dosisniveauet ikke opnås uden oteracil på grund af forekomsten af dosisbegrænsende toksiciteter (grad 3 diarré hos 2 patienter og hjerte/respirationsstop hos 1 patient) i behandlingsarmen med tegafur + gimeracil.
English: Gender, n (%)
Danish: Køn, n (%)
English: Manufacturer Nordic Pharma Tolweg 15
Danish: Fremstiller Nordic Pharma Tolweg 15
English: Caution is advised as co-administration of Teysuno and coumarin anticoagulation therapy may increase the risk of bleeding (see section 4.4).
Danish: Det tilrådes at udvise forsigtighed, eftersom samtidig indgift af Teysuno og coumarin antikoagulantia eller coumarinderivater kan øge blødningsrisikoen (se pkt.
English: Dose modifications for Teysuno for adverse reactions in general except for haematologic and renal toxicities
Danish: Dosisændring af Teysuno på grund af generelle bivirkninger undtagen hæmatologiske og renale toksiciteter.
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
Danish: Teysuno kan ikke erstattes af andre fluoropyrimidinbaserede lægemidler hæmmere af enzymet CYP2A6, som aktiverer Teysuno, såsom tranylcypromin og methoxsalen - folinsyre (bruges ofte ved kemoterapi med methotrexat) - blodfortyndende lægemidler: coumarin antikoagulanter såsom warfarin - medicin til behandling af epileptiske kramper/anfald eller rysten, såsom phenytoin - medicin mod urinsyregigt såsom allopurinol
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.
Danish: Gennemsnitlig AUC0-inf og Cmaks for 5-FU var ca. 3 gange større efter indgift af Teysuno (50 mg udtrykt som tegafurindhold) end efter indgift af tegafur alene (800 mg), mens AUC0-inf og Cmaks værdier for 5-FU metabolitten α-fluoro-β-alanin (FBAL) var ca. 15 til 22 gange lavere efter indgift af Teysuno end efter indgift af tegafur.
English: It should be taken with water at least 1 hour before or 1 hour after a meal (see section 4.2).
Danish: Lægemidlet skal indtages med vand mindst 1 time inden eller 1 time efter et måltid (se pkt.
English: Teysuno is an oral fluoropyrimidine anti-cancer medicinal product.
Danish: Teysuno er et oralt, anti-cancer lægemiddel med fluoropyrimidin.
English: • Pregnancy and breast-feeding.
Danish: • Graviditet og amning.
English: Table 3: Teysuno dose reduction schedule for treatment-related toxicities in general, except for haematologic and renal toxicities
Danish: Tabel 3: Dosisreduktionsplan for generelle, behandlingsrelaterede toksiciteter forårsaget af Teysuno, undtagen hæmatologiske og renale toksiciteter Grad af toksiciteta
English: Platelet count ≥100 x 109/l
Danish: Trombocyttal ≥100 x 109/l
English: - Do not use Teysuno after the expiry date which is stated on the outer carton and blister after EXP.
Danish: - Brug ikke Teysuno efter den udløbsdato, der står på pakningen.
English: Lactose (one type of sugar).
Danish: Teysuno indeholder lactose (et sukkerstof).
English: Table 6: Minimum criteria to resume Teysuno treatment following its suspension due to a toxicity Non-haematologic
Danish: Tabel 6: Minimumskriterier for genoptagelse af Teysuno-behandling efter pausering på grund af toksicitet
English: However, polyglutamated methotrexate inhibits thymidylate synthase and dihydrofolate reductase, potentially increasing cytotoxicity of 5-FU.
Danish: Polyglutameret methotrexat hæmmer thymidylatsyntase og dihydrofolatreduktase, hvilket potentielt kan øge cytotoksiciteten af 5-FU.
English: Advanced gastric cancer
Danish: Fremskreden ventrikelcancer
English: Neoplasms benign, malignant and unspecified (Incl.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)
English: Tumour haemorrhage, cancer pain
Danish: Tumorblødning, cancersmerter
English: - Mental: seeing and hearing some things that are not there, personality change, unable to sit still, confusion, feeling of nervousness, depression, sexual dysfunction - Nerve:, voice disorder, inability to speak and understand words, memory problem, unsteady gait, balance problems, one sided body weakness, sleepiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, seizures
Danish: - Psykisk: Se og høre ting der ikke er der, personlighedsændring, manglende evne til at sidde stille, forvirring, nervøsitet, depression, seksuel dysfunktion - Nerver: Stemmelidelser, manglende evne til at tale og forstå ord, hukommelsesproblem, usikker gang, balanceproblemer, svækkelse i den ene side af kroppen, søvnighed,
English: There were no significant differences in AUCs of 5-FU, tegafur, gimeracil, or oteracil after either single or multiple dose administration of Teysuno 30 mg/m2 twice daily in patients with mild,
Danish: Der var ingen signifikante forskelle i AUC for 5-FU, tegafur, gimeracil eller oteracil efter indgift af enten enkelt- eller flerdosis Teysuno 30 mg/m2 to gange dagligt hos patienter med mildt, moderat eller svært nedsat leverfunktion sammenlignet med patienter med normal leverfunktion.
English: The capsules should be taken by mouth with water at least 1 hour before or 1 hour after a meal (see section 5.2).
Danish: Kapslerne skal indtages gennem munden med vand mindst 1 time inden eller 1 time efter et måltid (se pkt.
English: This leaflet was last revisedin
Danish: Denne indlægsseddel blev senest ændret