FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take too many Jalra tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Danish: Hvis du tager for mange Jalra tabletter, eller hvis en anden har taget din medicin, skal du straks kontakte din læge.
English: No data are available (see also section 5.1).
Danish: Der foreligger ingen data (se også pkt.
English: Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals.
Danish: Insulin er et stof, som er med til at sænke blodsukkeret, især efter måltiderne.
English: Oral use Jalra can be administered with or without a meal (see also section 5.2).
Danish: Oral anvendelse Jalra kan tages med eller uden mad (se også pkt.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: YDRE ÆSKE MED MULTIPAKNING (INKLUSIV BLUE BOX)
English: Liver function tests should be performed prior to the initiation of treatment with Jalra in order to know the patient's baseline value.
Danish: Leverfunktionstest skal udføres før initiering af behandling med Jalra for at kende patientens baseline-værdi.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: YDRE ÆSKE MED MULTIPAKNING (UDEN BLUE BOX)
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
Danish: C] vildagliptin blev ca. 85 % af dosis udskilt i ruinen, og 15 % af dosis genfindes i fæces.
English: Talk to your doctor, pharmacist or nurse before taking Jalra.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Jalra
English: If it is almost time for your next dose, skip the dose you missed.
Danish: Hvis det næsten er tid til næste dosis, springer du den glemte dosis over.
English: Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product.
Danish: Af disse patienter fik 2.264 patienter vildagliptin som monoterapi, og 1.520 patienter fik vildagliptin kombineret med et andet lægemiddel.
English: • Do not use any Jalra pack that is damaged or shows signs of tampering.
Danish: • Brug ikke Jalra, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: In vitro data in human kidney microsomes suggest that the kidney may be one of the major organs contributing to the hydrolysis of vildagliptin to its major inactive metabolite, LAY151.
Danish: In vitro data i humane nyre-mikrosomer indikerer, at nyren kan være et af de hovedorganer, der medvirker til hydrolysen af vildagliptin til dets inaktive hovedmetabolit, LAY151.
English: Your doctor may wish to alter your dose of Jalra if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids(generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Danish: Din læge vil muligvis ønske at ændre din Jalra-dosis, hvis du tager anden medicin såsom: - thiazider eller andre diuretika (også kaldet vanddrivende tabletter) - kortikosteroider (bruges normalt til at behandle betændelseslignende reaktioner) - Medicin, der påvirker skjoldbruskkirtlen - visse typer medicin, der påvirker nervesystemet.
English: Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
Danish: Selv om der ikke er set øget forekomst af hudlæsioner i kliniske undersøgelser, var der begrænset erfaring hos patienter med diabetiske hudkomplikationer.
English: Multipack: 336 (3 packs of 112) tablets.
Danish: Multipakning: 336 (3 pakker a 112) tabletter.
English: Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for 10 days.
Danish: Oplysningerne om de sandsynlige symptomer på overdosering er taget fra et studie af tolerabilitet af stigende doser hos raske forsøgspersoner, som fik Jalra i 10 dage.
English: There was no correlation between the severity of the hepatic disease and changes in the exposure to vildagliptin.
Danish: Der var ingen korrelation mellem graden af leversygdom og ændringerne i eksponering for vildagliptin.
English: Vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing CHF.
Danish: Vildagliptin blev ikke forbundet med en ændring i venstre ventrikels funktion eller forværring af allerede eksisterende CHF.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Danish: Det anbefales derfor, i overensstemmelse med rutinekontrollen af diabetespatienten, at monitorere for hudlæsioner, såsom blære- og sårdannelse.
English: It is not known if Jalra passes into breast milk.
Danish: Der er uvist om Jalra passerer ind i modermælken.
English: The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species and the high systemic exposure ratios at which tumours were observed.
Danish: Den øgede incidens af disse tumorer hos mus anses ikke for at udgøre en signifikant risiko for mennesker på grund af vildagliptins og dets hovedmetabolits manglende genotoksicitet, forekomsten af tumorer hos kun én art og de høje systemiske eksponeringsratioer, som tumorerne blev observeret ved.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Danish: Vildagliptin har et lavt potentiale for interaktion med samtidigt administrerede lægemidler.
English: More than 15,000 patients with type 2 diabetes participated in double-blind placebo- or activecontrolled clinical trials of up to more than 2 years' treatment duration.
Danish: Mere end 15.000 patienter med type 2-diabetes deltog i dobbeltblindede, placebo- eller aktivkontrollerede kliniske forsøg af op til over 2 års varighed.
English: The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations.
Danish: De fleste bivirkninger i disse forsøg var milde og forbigående og krævede ikke afbrydelse af behandlingen.
English: Due to lack of human data, Jalra should not be used during pregnancy.
Danish: På grund af manglende data for mennesker bør Jalra ikke anvendes under graviditet.
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH02
Danish: Farmakoterapeutisk klassifikation: Lægemidler til diabetes, dipeptidylpeptidase 4 (DPP-4)-hæmmere, ATC-kode: A10BH02
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal.
Danish: Patienter, som udvikler forhøjede transaminaseniveauer, skal monitoreres med en sekundær evaluering af leverfunktionen for at bekræfte resultatet og skal derefter følges med hyppige leverfunktionstest, indtil abnormaliteten/-erne er tilbage på normalen.
English: Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Jalra bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Danish: Anvendelse af vildagliptin er blevet forbundet med en risiko for udvikling af akut pankreatitis.
English: Liver function should be monitored during treatment with Jalra at three-month intervals during the first year and periodically thereafter.
Danish: Leverfunktionen skal monitoreres under behandling med Jalra med 3 måneders interval i det første år og derefter regelmæssigt.
English: • if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
Danish: • hvis du har type 1-diabetes (sukkersyge, hvor din krop ikke producerer insulin), eller hvis du er i en tilstand kaldet diabetisk ketoacidose.
English: DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Danish: DPP-4 bidrager delvist til hydrolysen af vildagliptin på basis af et in vivostudie af rotter med DPP-4-mangel.
English: At study endpoint (2 years), the HbA1c was similar to baseline values in both treatment groups and the body weight changes and hypoglycaemia differences were maintained.
Danish: Ved forsøgets afslutning (2 år) var HbA1c sammenlignelig med baseline-værdier i begge behandlingsgrupper, og ændringerne i kropsvægt og hypoglykæmi blev opretholdt.
English: Doses higher than 100 mg are not recommended.
Danish: Doser på over 100 mg frarådes.
English: Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Danish: Jalra 50 mg tabletter er runde, hvide til svagt lysegule og flade præget med ”NVR” på den ene side og ”FB” på den anden side.
English: • The active substance is vildagliptin.
Danish: • Aktivt stof: vildagliptin.
English: Animal studies have shown excretion of vildagliptin in milk.
Danish: Dyreforsøg har vist, at vildagliptin udskilles i mælk.
English: It can also develop if the body produces too much glucagon.
Danish: Du kan også få det, hvis kroppen producerer for meget glucagon (et hormon).
English: • 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.
Danish: • 50 mg daglig om morgenen, hvis du har moderat eller svær nyresygdom, eller hvis du er i dialyse.
English: LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Danish: LAY151-koncentrationerne var ca. 2-3 gange højere end hos patienter med svært nedsat nyrefunktion.
English: Your doctor will prescribe Jalra either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Danish: Din læge kan ordinere Jalra enten alene eller sammen med visse andre typer medicin mod sukkersyge, som du allerede tager, hvis disse har vist sig ikke at være tilstrækkeligt effektive til at kontrollere sukkersygen.
English: As monotherapy - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
Danish: Som monoterapi - hos patienter, som er utilstrækkeligt kontrolleret med diæt og motion alene, og for hvem metformin ikke er egnet på grund af kontraindikationer eller intolerans.
English: Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise.
Danish: Glucagon er et stof, som udløser en produktion af sukker i leveren, og det får blodsukkeret til at stige.
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Jalra.
Danish: Du bør også være særlig opmærksom på nye vabler eller sår, som du får, mens du tager Jalra.
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min).
Danish: Der kræves ingen dosisjustering for patienter med let nedsat nyrefunktion (kreatininclearance ≥ 50 ml/min).
English: Following oral administration in the fasting state, vildagliptin is rapidly absorbed, with peak plasma concentrations observed at 1.7 hours.
Danish: Efter oral administration fastende absorberes vildagliptin hurtigt med maksimal plasmakoncentration ved 1,7 timer.
English: Ethnic group Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Danish: Begrænsede data tyder på, at etnicitet ikke har nogen større indflydelse på vildagliptins farmakokinetik.
English: In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Danish: Hos ikke-diabetiske personer (normal glykæmi) stimulerer vildagliptin ikke insulinsekretionen eller sænker glucoseniveauet.
English: 68.8% and 80.5% of the patients with moderate and severe renal impairment respectively were treated with insulin (mean daily dose of 56 units and 51.6 units respectively) at baseline.
Danish: 68,8 % og 80,5 % af patienterne med henholdsvis moderat og svært nedsat nyrefunktion blev behandlet med insulin (gennemsnitlig daglig dosis på henholdsvis 56 enheder og 51,6 enheder) ved baseline.
English: These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
Danish: Disse transaminaseforhøjelser var generelt asymptomatiske, ikkeprogredierende og ikke associeret med kolestase eller gulsot.
English: Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Danish: Patienter, som oplever svimmelhed som en bivirkning, bør derfor undgå at køre bil eller betjene maskiner.
English: Following withdrawal of treatment with Jalra and LFT normalisation, treatment with Jalra should not be reinitiated.
Danish: Efter behandlingsophør med Jalra og normalisering af leverfunktion, bør behandling med Jalra ikke genoptages.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med vildagliptin i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: * p< 0.05 for comparison versus placebo
Danish: * p< 0,05 for sammenligning mod placebo
English: Some patients have had the following side effects while taking Jalra, metformin and a sulphonylurea: • Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra, metformin og et sulfonylurinstof: • Almindelige: Svimmelhed, rysten, svaghed, lavt blodsukker, øget svedtendens
English: Jalra works by making the pancreas produce more insulin and less glucagon.
Danish: Jalra virker ved at få bugspytkirtlen til at producere mere insulin og mindre glucagon.
English: How Jalra works
Danish: Hvordan Jalra virker
English: There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.
Danish: Der kan være en øget risiko for angioødem hos patienter, som samtidig tager ACE-hæmmere (se pkt.
English: Adverse reactions reported in patients who received Jalra in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Danish: De bivirkninger, der blev rapporteret hos patienter, der fik Jalra som monoterapi i dobbeltblindede studier og tillægsbehandlinger, er opført nedenfor for hver indikation efter organsystemklasse og absolut hyppighed.
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Danish: Administration af vildagliptin resulterer i hurtig og fuldstændig hæmning af DPP-4-aktiviteten, hvilket resulterer i øgede fastende og postprandiale endogene niveauer af inkretinhormonerne GLP-1 (glukagonlignende peptid 1) og GIP (glucoseafhængigt insulinotropt polypeptid).
English: Driving and using machines If you feel dizzy while taking Jalra, do not drive or use machines.
Danish: Trafik- og arbejdssikkerhed Hvis du føler dig svimmel, når du tager Jalra, må du ikke køre bil eller betjene maskiner.
English: The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.
Danish: De fleste tilfælde var milde og forsvandt ved fortsat vildagliptin behandling.
English: 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
Danish: 7 tabletter 14 tabletter 28 tabletter 30 tabletter 56 tabletter 60 tabletter 90 tabletter 112 tabletter 180 tabletter 336 tabletter
English: A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
Danish: En større andel af tilfælde blev rapporteret, når vildagliptin blev administreret i kombination med en ACE-hæmmer (angiotensin converting enzyme hæmmer).
English: No studies on the effect on human fertility have been conducted for Jalra (see section 5.3).
Danish: Der er ikke udført studier vedrørende Jalras virkning på human fertilitet (se pkt.
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Danish: Ved 600 mg oplevede en forsøgsperson ødem i hænder og fødder og en stigning i kreatininfosfokinase (CPK), aspartataminotransferase (ASAT), C-reaktivt protein (CRP) og myoglobin.
English: Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.
Danish: Resultaterne af studier med disse orale antidiabetika har ikke vist nogen klinisk relevante farmakokinetiske interaktioner.
English: Table 7 Post-marketing adverse reactions
Danish: Tabel 7 Bivirkninger fra post-marketing
English: Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Danish: Vildagliptin er ikke et cytokrom P (CYP) 450-enzymsubstrat og hæmmer eller inducerer ikke CYP 450-enzymer, og der vil derfor være lav risiko for interaktion med aktive stoffer, som er substrater, hæmmere eller inducere af disse enzymer.
English: Lactose, anhydrous Cellulose, microcrystalline Sodium starch glycolate (type A) Magnesium stearate
Danish: Lactose, vandfri Cellulose, mikrokrystallinsk Natriumstivelseglycoat (type A) Magnesiumstearat
English: You should not use Jalra during pregnancy.
Danish: Du må ikke tage Jalra under graviditet.
English: Combination with pioglitazone, metformin and glyburide
Danish: Kombination med pioglitazon, metformin og glyburid
English: AUC of the metabolites LAY151 and BQS867 increased on average about 1.5, 3 and 7-fold in patients with mild, moderate and severe renal impairment, respectively.
Danish: AUC af metabolitterne LAY151 og BQS867 blev øget gennemsnitlig ca. 1,5, 3 og 7 gange hos patienter med henholdsvis let, moderat og svært nedsat nyrefunktion.
English: The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the glucuronide (BQS867) and the amide hydrolysis products (4% of dose).
Danish: Hovedmetabolitten (LAY 151), som er farmakologisk inaktiv og hydrolyseproduktet af cyanodelen, gør rede for 57 % af dosis, efterfulgt af glukuronidet (BQS867) og amidhydrolyseprodukterne (4 % af dosis).
English: Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:
Danish: Vildagliptin er indiceret til behandling af type 2-diabetes mellitus hos voksne:
English: In these trials, vildagliptin was administered as monotherapy in drugnaïve patients with type 2 diabetes or in combination in patients not adequately controlled by other antidiabetic medicinal products.
Danish: I disse forsøg blev vildagliptin givet som monoterapi til medicin-naive patienter med type 2-diabetes eller som kombinationsbehandling til patienter, som var utilstrækkeligt kontrolleret med andre antidiabetika.
English: White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet.
Danish: Hvid til svagt lysegul, rund (8 mm i diameter), flad tablet med skrå kant.
English: A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Danish: Der blev udført et toårigt karcinogenicitetsstudie på rotter ved orale doser på op til 900 mg/kg (ca. 200 gange human eksponering ved den maksimale anbefalede dosis).
English: Limited data from patients with end stage renal disease (ESRD) indicate that vildagliptin exposure is similar to that in patients with severe renal impairment.
Danish: Begrænsede data fra patienter med nyresygdom i sidste stadie (end-stage renal disease: ESRD) indikerer, at eksponeringen for vildagliptin er sammenlignelig med den, der ses hos patienter med svært nedsat nyrefunktion.
English: Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Jalra therapy is recommended.
Danish: Hvis en øgning i ASAT eller ALAT på 3x ULN eller derover varer ved, anbefales seponering af Jalra.
English: If you think you may be allergic to vildagliptin or any of the other ingredients of Jalra, do not take this medicine and talk to your doctor.
Danish: Hvis du tror, du er overfølsom over for vildagliptin eller et af de øvrige indholdsstoffer i Jalra, må du ikke tage medicinen, men skal henvende dig til din læge.
English: Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 47,82 mg lactose (vandfri).
English: Combination with amlodipine, ramipril, valsartan or simvastatin
Danish: Kombination med amlodipin, ramipril, valsartan eller simvastatin
English: The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.
Danish: Eksponeringen for vildagliptin efter en enkelt dosis hos patienter med let og moderat nedsat leverfunktion var reduceret (med henholdsvis 20 % og 8 %), mens eksponeringen for vildagliptin hos patienter med stærkt nedsat leverfunktion var øget med 22 %.
English: • Store in the original package in order to protect from moisture.
Danish: • Opbevares i den originale pakning for at beskytte mod fugt.
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Danish: Den større øgning af insulin/glukagon-ratioen under hyperglykæmi på grund af forhøjede inkretinhormonniveauer bevirker, at der sker et fald i fastende og postprandial glucoseproduktion i leveren, hvilket fører til mindsket glykæmi.
English: There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.
Danish: Der er ingen erfaringer med anvendelse af vildagliptin i kliniske forsøg med patienter med NYHAfunktionsklasse IV, og vildagliptin bør derfor ikke anvendes til disse patienter.
English: There is limited experience in patients with ESRD on haemodialysis.
Danish: Der er begrænsede erfaringer med patienter med ESRD i hæmodialyse.
English: You should not use Jalra if you are breast-feeding or plan to breast-feed.
Danish: Du må ikke tage Jalra, hvis du ammer eller planlægger at amme.
English: This helps to control the blood sugar level.
Danish: Det hjælper med at kontrollere blodsukkeret.
English: Some patients have had the following side effects while taking Jalra and insulin (with or without metformin):
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra og insulin (med eller uden metformin):
English: Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose).
Danish: Vildagliptin fjernes ved hæmodialyse i begrænset omfang (3 % over en 3-4 timers hæmodialysesession startende 4 timer efter dosering).