FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).
Danish: Frekvenserne defineres således: almindelig (>1/100, <1/10); usædvanlig (>1/1.000, <1/100); sjælden (>1/10.000, <1/1.000); meget sjælden (<1/10.000).
English: A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients when nateglinide is co-administered with CYP2C9 inhibitors.
Danish: En mere langvarig effekt og muligvis risiko for hypoglykæmi kan ikke udelukkes hos patienter når nateglinid administreres sammen med CYP2C9-hæmmere.
English: However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms.
Danish: Overdosering kan dog medføre kraftig glukosenedsættende virkning med udvikling af hypoglykæmisymptomer.
English: When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected.
Danish: Når nateglinid indgives postprandialt, påvirkes absorptionen (AUC) af stoffet ikke.
English: The decrease from baseline in HbA1c was -0.41% in the nateglinide plus metformin group and -0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI -0.03, 0.36]).
Danish: Formindskelsen af HbA1c fra baseline var -0,41% i nateglinid plus metformin gruppen og -0,57% i gliclazid plus metformin gruppen (forskel 0,17%, [95% KI -0,03,
English: If you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor.
Danish: Hvis du får symptomer på lavt blodsukker, skal du spise eller drikke noget, der indeholder sukker, og tale med din læge.
English: Rare: Hypersensitivity reactions such as rash, itching and urticaria.
Danish: Sjældne: Hypersensibilitetsreaktioner som udslæt, kløe og urticaria.
English: In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC (~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination half-life.
Danish: I et interaktionsstudie med sulfinpyrazon, en CYP2C9 hæmmer, blev der observeret en moderat øgning af nateglinid AUC (~28%) hos raske frivillige, uden ændring i den gennemsnitlige Cmax og elimineringshalveringstiden.
English: Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03
Danish: Farmakoterapeutisk klassifikation: D-phenylalaninderivat, ATC-kode: A10 BX 03
English: It is recommended that Trazec be administered prior to meals.
Danish: Det anbefales, at Trazec indgives før måltiderne.
English: The advisability of driving should be considered in these circumstances.
Danish: I disse tilfælde bør det overvejes, om bilkørsel kan tilrådes.
English: In completed clinical trials, symptoms of hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone,
Danish: I afsluttede kliniske undersøgelser blev symptomer på hypoglykæmi rapporteret i 10,4% af tilfældene med nateglinid monoterapi, 14,5% med nateglinid og metformin i kombination, 6,9% med metformin alene, 19,8% med glibenclamid alene og 4,1% med
English: People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia).
Danish: Diabetikere får af og til symptomer på lavt blodsukker (også kaldet hypoglykæmi).
English: Interaction studies with a 3A4 inhibitor have not been carried out in vivo.
Danish: Der har ikke været udført in vivo interaktionsstudier med 3A4-hæmmere.
English: Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1C <7.5%).
Danish: Symptomer på hypoglykæmi (ikke bekræftet af blodglukosekoncentrationen) blev observeret hos patienter, hvis baseline HbA1A var tæt på det terapuetiske mål (HbA1c <7,5%).
English: Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8).
Danish: Der er observeret hypoglykæmi hos patienter med type 2 diabetes i behandling med diæt og motion og hos patienter i behandling med orale antidiabetika (se pkt.
English: Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with metformin 500 mg three times daily monotherapy: -1.23 [95% CI: -1.48; -0.99] and with nateglinide 120 mg three times daily monotherapy -0.90 [95% CI: -1.14; -0.66]).
Danish: Nateglinid's virkning i monoterapi var mindre end metformins (fald i HbA1c (%) med 500 mg metformin 3 gange daglig i monoterapi: -1,23 [95% CI: -1,48; -0,99] og med nateglinid 120 mg 3 gange daglig i monoterapi: -0,90 [95% CI: -1,14; -0,66]).
English: Conversely, the coadministration of food or a glucose infusion results in an enhancement of insulin secretion.
Danish: Omvendt medfører samtidig fødeindtagelse eller glukoseinfusion en forøgelse af insulinsekretionen.
English: Insulin is a substance produced by a body organ called the pancreas.
Danish: Insulin er et stof produceret i bugspytkirtlen.
English: This may be increased to 120 mg three times daily.
Danish: Denne dosis kan øges til 120 mg 3 gange daglig før måltiderne.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products metabolised by CYP2C9 and CYP3A4.
Danish: Nateglinid har in vivo ingen klinisk relevant virkning på farmakokinetikken af lægemidler der metaboliseret af CYP2C9 og CYP3A4.
English: Take special care with Trazec
Danish: Vær særlig forsigtig med at anvende Trazec
English: Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent.
Danish: Tilgængelige data fra både in vitro og in vivo forsøg indikerer, at nateglinid overvejende metaboliseres af CYP2C9 med CYP3A4 involveret i mindre grad.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving or operating machinery.
Danish: Patienterne bør rådes til at tage særlige forholdsregler for at undgå hypoglykæmi under bilkørsel og ved maskinbetjening.
English: As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide.
Danish: Som ved andre antidiabetika er der observeret symptomer på hypoglykæmi efter indtagelse af nateglinid.
English: Elderly, malnourished patients and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucoselowering effect of these treatments.
Danish: Ældre underernærede patienter og patienter med nedsat adrenal- eller hypofysefunktion eller alvorlig nedsat nyrefunktion er mere modtagelige for disse behandlingers glukosenedsættende virkning.
English: when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c.
Danish: Når nateglinid indtages før et måltid, genetableres den tidlig eller førstefase insulinsekretion, som ikke eksisterer hos patienter med type 2 diabetes, hvilket medfører reduktion af postprandial glukose og HbA1c.
English: The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting enzyme inhibitors (ACEI).
Danish: Følgende lægemiddelgruppe kan forøge nateglinid's hypoglykæmiske virkning: Angiotensin konverterende enzymhæmmere (ACE-hæmmere).
English: Common: Abdominal pain, diarrhoea, dyspepsia, nausea.
Danish: Almindelige: abdominalsmerter, diarré, dyspepsi, kvalme.
English: These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness.
Danish: Disse symptomer omfatter sveden, rysten, svimmelhed, sultfornemmelse, palpitation, kvalme, træthed og svaghed.
English: Elderly: Age did not influence the pharmacokinetic properties of nateglinide.
Danish: Ældre: Alder havde ingen indflydelse på nateglinid's farmakokinetiske egenskaber.
English: Do not breast-feed during treatment with Trazec.
Danish: Du bør ikke amme, mens du er i behandling med Trazec.
English: Nateglinide is extensively metabolised.
Danish: Nateglinid metaboliseres kraftigt.
English: Gender: No clinically significant differences in nateglinide pharmacokinetics were observed between
Danish: Køn: Der er ikke blevet observeret klinisk signifikante forskelle i nateglinids farmakokinetisk mellem
English: The pharmacokinetics of warfarin (a substrate for CYP3A4 and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration with nateglinide.
Danish: De farmakokinetiske egenskaber af warfarin (et substrat for CYP3A4 og CYP2C9), diclofenac (et substrat for CYP2C9) og digoxin er uforandret ved samtidig indgift af nateglinid.
English: Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers.
Danish: Hypoglykæmi kan være vanskelig at genkende hos patienter i behandling med β-blokkere.
English: Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less insulin is secreted as glucose levels fall.
Danish: Nateglinidinduceret insulinsekretion ved pankreatiske β-celler er glukosesensitiv, således at der udskilles mindre insulin, efterhånden som glukosekoncentrationerne falder.
English: Conversely, these medicinal products had no effect on the pharmacokinetics of nateglinide.
Danish: Omvendt havde disse stoffer ingen virkning på nateglinid's farmakokinetiske egenskaber.
English: As nateglinide is highly protein-bound, dialysis is not an efficient means of
Danish: Da nateglinid er kraftigt proteinbundet, elimineres det ikke effektivt fra
English: Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med arvelig galactoseintolerance, en særlig form af heræditær lactasemangel (Lapp lactase deficiency) eller glucose-galactose malabsorption bør ikke indtage dette lægemiddel.
English: Similarly, there was no clinically significant pharmacokinetic interaction of Trazec with other oral antidiabetic agents such as metformin
Danish: Ligeledes var der ingen klinisk signifikant farmakokinetisk interaktion mellem Trazec og andre orale antidiabetiske lægemiddelstoffer såsom metformin og glibenclamid.
English: Do not take a double dose of Trazec to make up for the one that you missed.
Danish: Du må ikke tage en dobbeltdosis Trazec som erstatning for glemte enkeltdoser.
English: The usual dose of Trazec to start with is 60 mg before the three main meals.
Danish: Den normale startdosis af Trazec er 60 mg før hvert af de 3 hovedmåltider.
English: Trazec 60 mgfilm-coated tablets Trazec 120 mg film-coated tablets Trazec 180 mg film-coated tablets Nateglinide
Danish: Trazec 60 mg filmovertrukne tabletter Trazec 120 mg filmovertrukne tabletter Trazec 180 mg filmovertrukne tabletter Nateglinid
English: Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15-50 ml/min) was comparable between renal subjects requiring haemodialysis and healthy subjects.
Danish: Selv om der er et fald på 49% i Cmax for nateglinid hos dialysepatienter, kunne den systemiske tilgængelighed og halveringstiden hos diabetikere med moderat til svært nedsat nyrefunktion (kreatininclearance 1550 ml/min) sammenlignes for hæmodialysekrævende nyrepatienter og raske personer.
English: Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics that distinguish it from other sulphonylurea receptor ligands.
Danish: Nateglinid lukker ATP-afhængige kaliumkanaler i den β-cellemembran med karakteristika, der adskiller den fra andre sulfonylurinreceptorligander.
English: Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Trazec.
Danish: Det er derfor ikke er nødvendigt med dosisjustering af digoxin, warfarin eller andre lægemidler, der er substrater for CYP2C9 eller CYP3A4, ved samtidig indgift af Trazec.
English: Although safety was not compromised in this population dose adjustment may
Danish: Selv om sikkerhed ikke var kompromiteret i denne population kan dosisjustering være
English: It is used by people with type 2 diabetes.
Danish: Det anvendes til mennesker med type 2 diabetes (denne form for diabetes kaldes også ikke
English: In rabbits, at maternally toxic doses a higher incidence of foetuses with no gallbladder was observed.
Danish: Ved indgift til kaniner blev der ved en for moderen toksisk dosis nateglinid observeret højere incidens af fostre uden
English: It is especially important that you tell your doctor or pharmacist if you are taking: Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high blood pressure and certain heart conditions).
Danish: Det er især vigtigt, at du giver lægen eller apoteket besked, hvis du på nuværende tidspunkt tager: - Betablokkere eller angiotensin konverteringsenzymhæmmere (ACE-hæmmere) (anvendes f.eks.
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er især vigtigt for patienter, som har reduceret eller manglende opmærksomhed på advarselssymptomerne på hypoglykæmi eller for de patienter, som ofte oplever hypoglykæmiske perioder.
English: Trazec is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are
Danish: Trazec er et lægemiddel, der sænker blodsukkeret (glukose), og som indtages gennem munden (denne type lægemidler kaldes også orale antidiabetika).
English: • Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative)
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne • Type 1 diabetes (insulinkrævende diabetes mellitus og C-peptid negative)
English: The recommended maximum daily dose is 180 mg three times daily to be taken before the three main
Danish: Den anbefalede maksimale daglige dosis er 180 mg tre gange daglig indtaget før hvert af de tre
English: In combination with metformin, which mainly affected fasting plasma glucose, the effect of nateglinide on HbA1c was additive compared to either agent alone.
Danish: I kombination med metformin, som primært påvirkede fasteplasmaglukose, var virkningen på HbA1c additiv sammenlignet med begge stoffer hver for sig.
English: Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout).
Danish: - Medicinnedbrydningshæmmere, såsom fluconazol (anvendes til behandling af svampeinfektioner), gemfibrozil (anvendes til behandling af forstyrrelser i blodets fedt- og kolesterolindhold) og sulfipyrazon (anvendes til behandling af kronisk gigt).
English: Nateglinide is a rapid, short-acting oral insulin secretagogue.
Danish: Nateglinid er hurtigt, korttidsvirkende oralt insulinsekretionsfremkaldende stof.
English: Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such
Danish: Sjældne bivirkninger kan være let abnormalitet ved leverfunktionsprøver og overfølsomhedsreaktioner
English: if you have another medical condition that may cause low blood sugar (e.g. an under-active
Danish: - hvis du har andre lidelser, som kan give lavt blodsukker (f.eks. nedsat hypofyse- eller
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apoteket herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Renal impairment: The systemic availability and half-life of nateglinide in diabetic patients with mild, moderate (creatinine clearance 31-50 ml/min) and severe (creatinine clearance 15-30 ml/min) renal impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in healthy subjects.
Danish: Nedsat nyrefunktion: Der var ingen klinisk signifikant forskel mellem nateglinid's systemiske tilgængelighed og halveringstid hos diabetikere med let, moderat (kreatininclearance 31-50 ml/min) og svært (kreatininclearance 15-30 ml/min) nedsat nyrefunktion (ikke i dialyse) og hos raske personer.
English: The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids,
Danish: Følgende lægemiddelgrupper kan reducere nateglinid's hypoglykæmiske virkning: Diuretika,
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to medical prescription
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Trazec, like other oral antidiabetic agents, is not recommended for use in pregnancy.
Danish: Ligesom andre orale antidiabetika anbefales Trazec ikke
English: If you do get symptoms of low blood sugar, eat or drink something containing sugar.
Danish: Hvis du får symptomer på lavt blodsukker, skal du spise eller drikke noget, der
English: Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you.
Danish: Selv om du får medicinsk behandling af din diabetes, er det vigtigt, at du fortsætter med at følge den
English: 4.5 Interaction with other medicinal products and other forms of interaction A number of medicinal products influence glucose metabolism and possible interactions should therefore be taken into account by the physician:
Danish: Flere lægemidler har indvirkninger på glukosemetabolismen, og mulige interaktioner som følge af dette bør derfor tages i betragtning af lægen.
English: Ελλάδα
Danish: Ikke relevant
English: If you have any further questions, ask your doctor or pharmacist.
Danish: - Kontakte din læge eller apotek, hvis De har yderligere spørgsmål.
English: Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Danish: Selv om sikkerheden ikke var kompromitteret hos denne patientgruppe kan dosisjustering set i lyset af lavt Cmax blive nødvendig.
English: Not all pack sizes or tablet strengths may be
Danish: Ikke alle pakningstørrelser eller tabletstyrker er nødvendigvis markedsført i dit land.
English: This is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia.
Danish: Dette er specielt vigtigt, hvis du har svage eller ingen forvarsler om fald i blodsukkernivauet, eller hvis du ofte oplever perioder med lavt blodsukker.
English: Take Trazec before meals (see section 3, “How to take Trazec”).
Danish: 3 ”Hvordan De anvender Trazec”).
English: When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Danish: Tab af den glykæmiske kontrol kan forekomme, hvis en patient, som er stabiliseret med et hvilket som helst oralt hypoglykæmisk stof, udsættes for stress i form af f.eks. feber, traume, infektion eller operation.
English: Nateglinide should be used with caution in patients with moderate hepatic impairment.
Danish: Særlige patientgrupper Nateglinid bør anvendes med forsigtighed til patienter med moderat nedsat leverfunktion.
English: It is best to take it right before a main meal but you can take it up to 30 minutes before.
Danish: Det er bedst at tage Trazec umiddelbart før et hovedmåltid, men det kan tages inden for 30 minutter,
English: Hypromellose Titanium dioxide (E171) Talc
Danish: Hypromellose Titandioxid (E 171) Talcum
English: Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen.
Danish: Følgende bivirkninger baseret på erfaring med nateglinid og andre hypoglykæmiske lægemidler er blevet observeret.
English: Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia.
Danish: Som andre insulinsekretionsfremkaldende stoffer kan nateglinid fremkalde hypoglykæmi.
English: 6.2 Incompatibilities Not applicable 6.3 Shelf life 3 years
Danish: 6.2 Uforligeligheder
English: The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
Danish: - Andre indholsstoffer er laktosemonohydrat; cellulose, mikrokrystallinsk; povidon;
English: Hepatic impairment: The systemic availability and half-life of nateglinide in non-diabetic subjects with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in
Danish: Nedsat leverfunktion: Der var ingen klinisk signifikant forskel mellem nateglinid's systemiske tilgængelighed og halveringstid hos ikke-diabetikere med let til moderat nedsat leverfunktion og hos
English: Silica, colloidal anhydrous
Danish: Silica, kolloid vandfri
English: If you have accidentally taken too many tablets, talk to a doctor straight away.
Danish: Søg straks læge, hvis du kommer til at tage for mange tabletter.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Der kræves ingen dosisjustering hos patienter med let til moderat nedsat nyrefunktion.
English: You are advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Det tilrådes, at du tager dine forholdsregler for at undgå lavt blodsukker, når du kører bil.
English: Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported.
Danish: Der er indberetninger om mavesmerter, forstoppelse, diarré, kvalme og opkastninger.
English: If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help - or make sure that someone else does this for you.
Danish: Søg omgående læge - eller få nogen til at tilkalde lægehjælp for dig - hvis du kan mærke, at en kraftig hypoglykæmisk episode er på vej (som kan medføre bevidsthedstab eller kramper).
English: The active substance is nateglinide.
Danish: Hvad Trazec indeholder - Det aktive stof er nateglinid.
English: You should check with your doctor or
Danish: De bør konsultere
English: If you experience symptoms of low blood sugar - if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, “Possible side effects” - eat or drink something containing sugar.
Danish: Hvis du får symptomer på lavt blodsukker - hvis du bliver svimmel, uklar, sulten og rystende eller oplever andre af de symptomer, der er nævnt i pkt.
English: Trazec works by stimulating the pancreas to produce insulin more quickly.
Danish: Trazec fungerer ved at stimulere bugspytkirtlen, så den producerer insulin hurtigere, og det bidrager til at kontrollere blodsukkeret efter måltiderne.
English: 1 film-coated tablet contains 180 mg nateglinide.
Danish: 1 filmovertruken tablet indeholder 180 mg nateglinid.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Novartis Europharm Limited
English: The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
Danish: - Tabletovertrækker indeholder hypromellose; titandioxid (E171); talkum; macrogol og rød (60
English: 1 film-coated tablet contains 60 mg nateglinide.
Danish: 1 filmovertruken tablet indeholder 60 mg nateglinid.
English: Nateglinide is excreted in the milk following a peroral dose to lactating rats.
Danish: Efter oral dosering til diegivende rotter udskiltes nateglinid i modermælk.