FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratory studies showed that in sheep the vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year.
Danish: Laboratorieundersøgelserne viste, at vaccinen for fårs vedkommende begynder at virke 39 dage efter vaccinationen, og at beskyttelsen varer i ét år.
English: How does Syvazul BTV work?
Danish: Hvordan virker Syvazul BTV?
English: Do not pass it on to others.
Danish: Du bør ikke give det videre til andre.
English: You may need to read it again.
Danish: Du får muligvis behov for at læse den igen.
English: Absolute oral bioavailability is estimated to be 72%.
Danish: Absolut oral biotilgængelighed estimeres til 72%.
English: If you take more Trazec than you should
Danish: Hvis De tager mere Trazec, end De bør
English: The clinical experience in patients over 75 years of age is limited.
Danish: Den kliniske erfaring med patienter over 75 år er begrænset.
English: Trazec and older people Trazec can be used by people over 65 years of age.
Danish: Trazec og ældre Trazec kan anvendes af personer over 65 år.
English: Post-marketing data revealed very rare cases of erythema multiforme.
Danish: Post-marketing data har vist meget sjældne tilfælde af erythema multiforme.
English: Trazec and children and adolescents
Danish: Trazec og børn og unge
English: Treatment is therefore not recommended in these patient groups.
Danish: Behandling anbefales derfor ikke til disse patientgrupper.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 03.04.2001
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første godkendelse: 03.04.2001
English: If you forget to take a tablet simply take the next one before your next meal.
Danish: Hvis du glemmer at tage en tablet, skal du blot tage den næste før det næste måltid.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30°C.
English: See your doctor as soon as possible if you become pregnant during treatment.
Danish: Kontakt lægen så hurtigt som muligt, hvis du bliver gravid under behandlingen.
English: Your treatment may need to be adjusted.
Danish: Det kan være nødvendigt at justere behandlingen.
English: Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).
Danish: Nateglinid bør indtages 1-30 minutter før måltiderne (normalt morgenmad, frokost og aftensmad).
English: Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Danish: Trazec anbefales ikke til børn og unge (under 18 år), fordi virkningerne i denne aldersgruppe ikke er undersøgt.
English: if you have type 1 diabetes (i.e. your body does not produce any insulin).
Danish: - hvis du har type 1 diabetes (dvs. at din krop overhovedet ikke producerer insulin).
English: Take special care to avoid low blood sugar.
Danish: Vær særlig opmærksom på at undgå lavt blodsukker.
English: Nateglinide and its metabolites are rapidly and completely eliminated.
Danish: Nateglinid og dets metabolitter elimineres hurtigt og fuldstændigt.
English: if you have suffered a fever, an accident or an infection.
Danish: - hvis du har haft feber, har været ude for en ulykke eller har haft en infektion.
English: Swallow the tablets whole with a glass of water before the meal.
Danish: Tabletterne skal synkes hele med et glas vand før hovedmåltidet.
English: Nateglinide is rapidly and almost completely (≥ 90%) absorbed from an oral solution.
Danish: Nateglinid absorberes hurtigt og næsten fuldstændigt (≥90%) fra en oral opløsning.
English: An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Danish: En langtidsundersøgelse med nateglinid er ikke blevet udført, og derfor er langtidsfordelene associeret med forbedret glykæmisk kontrol ikke blevet vist.
English: In some cases your doctor may prescribe higher doses.
Danish: Din læge kan i visse tilfælde foreskrive en større dosis.
English: It helps to decrease blood sugar levels, especially after meals.
Danish: Det hjælper med at sænke blodsukkerniveauet, især efter måltiderne.
English: Via Provinciale Schito, 131 I-80058 Torre Annunziata - Napoli Italy
Danish: Via Provinciale Schito, 131 I-80058 Torre Annunziata - Napoli Italien
English: This medicine has been prescribed for you.
Danish: - Dette lægemiddel er ordineret til Dem personligt.
English: Like all medicines, Trazec can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Trazec have bivirkninger, selvom ikke alle får bivirkninger.
English: Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast
Danish: Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin, mens du er gravid eller
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på Deres apotek hvad De skal gøre ved medicin, der ikke længere er nødvendig.
English: The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be approximately 10 litres.
Danish: Nateglinid's steady-state distributionsvolumen baseret på intravenøse data vurderes til ca. 10 liter.
English: There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended.
Danish: Der er ingen data til rådighed om brugen af nateglinid til patienter under 18 år, og det anbefales derfor ikke til denne aldersgruppe.
English: In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals.
Danish: Hos patienter med type 2 diabetes begynder kroppen måske ikke at producere insulin hurtigt nok, efter at man har spist.
English: Some people are more likely to get symptoms of low blood sugar than others.
Danish: Nogle mennesker har større sandsynlighed for at udvikle symptomer på lavt blodsukker end andre.
English: 6-16% of the administered dose was excreted in the urine as unchanged drug.
Danish: Ca. 6-16% af den indgivne dosis blev udskilt med urinen i uændret form.
English: This depolarises the beta cell and leads to an opening of the calcium channels.
Danish: Dette depolariserer β-cellerne og medfører en åbning af calciumkanalerne.
English: For any information about this medicinal product, please contact the local representative of the
Danish: For yderligere information om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant
English: Medicines, including Trazec, may also produce symptoms of low blood sugar.
Danish: Visse lægemidler, herunder Trazec, kan også give symptomer på lavt blodsukker.
English: It is usually taken immediately (1 minute) before a meal but may be taken up to 30 minutes before meals.
Danish: Det bør normalt indtages umiddelbart (1 minut) før et måltid, men kan indtages indtil 30 minutter før
English: Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Trazec.
Danish: Alkohol kan forstyrre blodsukkerkontrollen, så det anbefales, at du taler med din læge om alkoholindtagelse under behandlingen med Trazec.
English: Nateglinide has shown a low potential for protein displacement in in vitro studies.
Danish: Nateglinid har vist lavt potentiale for proteindeplacering i in vitro-undersøgelser.
English: Studies in animals have shown developmental toxicity (see section 5.3).
Danish: Dyreundersøgelser har vist udviklingstoksicitet (se pkt.
English: Your doctor may adjust the dose of these medicines.
Danish: Det er muligt, at lægen justerer dosis af disse lægemidler.
English: There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot be assessed.
Danish: Der er ingen erfaring med anvendelse af nateglinid til gravide kvinder, hvorfor sikkerheden af Trazec ved human graviditet ikke kan vurderes.
English: The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c.
Danish: Den rekommenderede startdosis er 60 mg 3 gange daglig før måltiderne, specielt hos patienter der er nær HbA1c målet.
English: This results in a blood-glucose-lowering effect throughout the meal period.
Danish: Resultatet er en blodglukosenedsættende virkning under hele måltidet.
English: However, there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak plasma concentration (tmax).
Danish: Der er dog en forsinkelse i absorptionshastigheden karakteriseret ved et fald i Cmax samt en forsinkelse i opnåelse af maksimal plasmakoncentration (tmax).
English: Watch carefully for signs of low blood sugar, especially if you have exercised more strenuously than usual.
Danish: Vær på vagt over for symptomer på lavt blodsukker, især - hvis du har udøvet større fysisk aktivitet end normalt.
English: Take Trazec before the three main meals, usually:
Danish: Trazec skal tages før de 3 hovedmåltider, normalt:
English: At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis.
Danish: I sådanne tilfælde kan det være nødvendigt at standse behandlingen med orale hypoglykæmiske præparater og midlertidigt erstatte behandlingen med insulin.
English: if you know that you have a severe liver problem.
Danish: - hvis du ved, at du har en svær leverlidelse.
English: These were generally mild in nature and easily handled by intake of carbohydrates when necessary.
Danish: Symptomerne var generelt lette og nemme at behandle ved indtagelse af kulhydrat om nødvendigt.
English: A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache,
Danish: En meget sjælden bivirkning er hududslæt med blistre som rammer læber, øjne, mund sommetider
English: The extent of serum protein binding is independent of drug concentration over the test range of 0.1-10 μg Trazec/ml.
Danish: Omfanget af serumproteinbindingen er uafhængig af lægemiddelkoncentrationen i et testområde på 0,1-10 mikrogram Trazec/ml.
English: No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents.
Danish: Der er ikke udført kliniske undersøgelser af patienter med svært nedsat leverfunktion eller børn og unge.
English: Your doctor will determine the dosage you require.
Danish: Lægen afgør, hvilken dosis du skal tage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: Nateglinide was not teratogenic in rats.
Danish: Nateglinid viste ikke teratogenicitet hos rotter.
English: They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking.
Danish: Disse symptomer kan også være forårsaget af mangel på mad eller en for høj dosis af et eventuelt andet antidiabetikum.
English: Each blister pack contains 12, 60, 84, 120 or 360 tablets.
Danish: Hver blisterpakning indeholder 12, 60, 84, 120 eller 360 tabletter.
English: Diuretics (used in the treatment of high blood pressure).
Danish: - Diuretika (anvendes til behandling af for højt blodtryk).
English: Trazec tablets start to act quickly after you take them and are eliminated from the body rapidly.
Danish: Trazec tabletterne begynder at virke hurtigt, efter at du har indtaget dem, og stoffet udskilles hurtigt
English: The dosage of nateglinide should be determined by the physician according to the patient's
Danish: Dosis af nateglinid afgøres af lægen på baggrund af patientens behov.
English: In type 2 diabetic patients, the insulinotropic response to a meal occurs within the first 15 minutes following an oral dose of nateglinide.
Danish: Hos type 2 diabetikere indtræder den insulinotrope reaktion på et måltid inden for de første 15 minutter efter oral indgift af nateglinid.
English: Although it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in lactating women.
Danish: Selv om det ikke vides, om nateglinid udskilles i human modermælk, kan der være risiko for hypoglykæmi hos det ammede barn, og nateglinid bør derfor ikke gives til ammende kvinder.
English: Consistent with its short elimination half-life, there is no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily.
Danish: Konsistent med den korte elimineringshalveringstid er der ingen tilsyneladende akkumulation af nateglinid efter multiple doser på indtil 240 mg tre gange
English: Early insulin secretion is a mechanism for the maintenance of normal glycaemic control.
Danish: Tidlig insulinsekretion er en mekanisme til opretholdelse af normal blodglukosekontrol.
English: In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
Danish: Hos svækkede eller underernærede patienter bør initial- og vedligeholdelsesdosis være konservativ, og der kræves omhyggelig titrering for at undgå hypoglykæmisk reaktion.
English: The side effects caused by Trazec are usually mild to moderate.
Danish: Bivirkningerne ved Trazec er normalt lette til moderate.
English: There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic patients.
Danish: Der er et fald på 49% i Cmax for nateglinid hos dialysekrævende diabetikere.
English: There is no experience of an overdose of Trazec in clinical trials.
Danish: Der er ingen erfaring med overdosering af Trazec i kliniske undersøgelser.
English: Nateglinide is rapidly absorbed following oral administration of Trazec tablets prior to a meal, with mean peak drug concentration generally occurring in less than 1 hour.
Danish: Nateglinid absorberes hurtigt efter oral administration af Trazec tabletter før et måltid, og maksimal lægemiddelkoncentration optræder normalt inden for mindre end 1 time.
English: Take Trazec daily until your doctor tells you to stop.
Danish: Hvor længe skal Trazec tages Trazec skal tages dagligt, indtil lægen giver dig besked om at standse behandlingen.
English: Most of the [14C] nateglinide is excreted in the urine (83%), with an additional 10% eliminated in the faeces.
Danish: Størstedelen af 14C nateglinid udskilles i urinen (83%), mens yderligere 10% elimineres gennem fæces.
English: Insulin levels return to baseline within 3 to 4 hours, reducing post-meal
Danish: Insulinniveauerne returnerer til udgangsniveauet i løbet af 3-4 timer og reducerer
English: As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.
Danish: Da patienter med svær leversygdom ikke er undersøgt, er nateglinid kontraindiceret til denne patientgruppe.
English: Its effect is dependent on functioning beta cells in the pancreas islets.
Danish: Dets virkning afhænger af tilstedeværelsen af fungerende β-celler i de Langerhansske øer i pankreas.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTRE
English: Blisters: PVC/PE/PVDC moulded foil with aluminium lidding foil.
Danish: Blisterpakninger: PVC/PE/PVDC presset folie med bagbeklædning af aluminiumsfolie.
English: The main metabolites found in humans result from hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; activity of the main metabolites is about 5-6 and 3 times less potent than nateglinide, respectively.
Danish: Hovedmetabolitterne hos mennesker skyldes hydroxylation af isopropylsidekæden enten på methincarbon eller på en af methylgrupperne; hovedmetabolitternes aktivitet er henholdsvis ca. 5-6 og 3 gange mindre potent end nateglinid.
English: In vitro studies show that nateglinide is extensively bound (97-99%) to serum proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein.
Danish: In vitro-undersøgelser viser, at nateglinid er kraftigt bundet (97-99%) til serumproteiner, overvejende serumalbumin og i mindre grad glykoprotein α1-syre.
English: Do not use Trazec after the expiry date stated on the carton after EXP.
Danish: Anvend ikke Trazec efter udløbsdatoen, som er angivet på kartonen efter EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol.
Danish: Risikoen for hypoglykæmi hos type 2 diabetikere kan øges ved kraftig motion eller alkoholindtagelse.
English: Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Danish: Nateglinid er indiceret som kombinationsbehandling med metformin til patienter med utilstrækkelig kontrolleret type 2 diabetes på trods af en maksimal tolerabel dosis af metformin alene.
English: Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
Danish: - Kortikosteroider som prednison og kortison (anvendes til behandling af inflammationstilstande).
English: The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually
Danish: De mest almindelige bivirkninger er symptomer på lavt blodsukker (hypoglykæmi), som normalt er
English: Plasma concentrations decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of Trazec in volunteers and type 2 diabetic patients.
Danish: Plasmakoncentrationerne falder hurtigt, og nateglinid's elimineringshalveringstid var gennemsnitligt typisk på 1,5 timer i alle undersøgelser af Trazec med frivillige forsøgspersoner og type 2 diabetikere.
English: Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Trazec may also be monitored with 1-2 hour post-meal glucose.
Danish: Da den primære behandlingseffekt af Trazec er at reducere prandial glukose (som bidrager til HbA1c), kan den terapeutiske reaktion på Trazec også måles med 1-2 timer postprandial glukose.
English: Electrophysiological studies demonstrate that nateglinide has 45-300-fold selectivity for pancreatic beta cell versus cardiovascular K+ATP channels.
Danish: Elektrofysiologiske undersøgelser viser, at nateglinid har 45-300 gange større selektivitet for pankreatiske β-celler i forhold til kardiovaskulære K+ATP-kanaler.
English: Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and post-natal development.
Danish: Prækliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af siikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenecitet og toksicitet for fertilitet og postnatal udvikling.
English: In a clinical study in patients, Trazec was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Danish: I en klinisk patientundersøgelse blev Trazec indgivet i stigende doser indtil 720 mg dagligt i 7 dage, hvilket var veltolereret.
English: Talk to your doctor if you have any further questions or you think that any of these may apply to you.
Danish: Kontakt lægen, hvis du har yderligere spørgsmål eller mener, at du falder ind under en af ovennævnte grupper.
English: Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents.
Danish: Nateglinid er et aminosyrederivat (phenylalanin), som kemisk og farmakologisk er forskelligt fra andre antidiabetika.
English: Combination with metformin is associated with an increased risk of hypoglycaemia compared to
Danish: Kombination med metformin associeres med øget risiko for hypoglykæmi sammenlignet med
English: Severe hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with intravenous glucose.
Danish: Kraftige hypoglykæmiske reaktioner med koma, kramper eller andre neurologiske symptomer bør behandles med intravenøs glukose.
English: The efficacy of nateglinide in combination with metformin has been compared to the combination of gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a superiority design.
Danish: Nateglinid's virkning i kombination med metformin er blevet sammenlignet med kombinationen af gliclazid og metformin i et 6 måneders randomiseret, dobbelt-blindt studie i 262 patienter, hvor et superiority design blev anvendt.
English: Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide.
Danish: Mindre identificerede metabolitter var en diol, en isopropen og acylglukuronide(r) af nateglinid; kun den mindre isoprenmetabolit har en aktivitet, der er næsten lige så potent som nateglinid.
English: Packs contain 12, 60, 84, 120 and 360 tablets.
Danish: Pakninger med 12, 60, 84, 120 og 360 tabletter.
English: Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin.
Danish: Lægen kan ordinere Trazec sammen med et andet oralt antidiabetikum, der indeholder metformin.
English: The resulting calcium influx enhances insulin secretion.
Danish: Det resulterende calciuminflux forøger insulinsekretionen.
English: When these medicinal products are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycaemic control.
Danish: Hvis behandling med disse lægemidler påbegyndes eller standses hos patienter i behandling med nateglinid, skal patienten observeres grundigt for ændringer i den glykæmiske kontrol.
English: If any of these apply to you, monitor your blood sugar levels more carefully.
Danish: Hvis du er omfattet af et eller flere af disse forhold, bør du kontrollere dit blodsukkerniveau meget
English: Particular caution is recommended when nateglinide is co-administered with other more potent inhibitors of CYP2C9, e.g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers
Danish: Særlig forsigtighed anbefales når nateglinid administreres sammen med andre mere potente CYP2C9hæmmere, f.eks. fluconazol eller gemfibrozil, eller hos patienter, der er kendt for at være dårlige til at
English: Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements.
Danish: Justering af dosis bør baseres på regelmæssige målinger af glykosyleret hæmoglobin (HbA1c).
English: Hypoglycaemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns.
Danish: Hypoglykæmisymptomer uden bevidsthedstab eller neurologiske symptomer bør behandles med oral glukose og justering af dosis og/eller af spisemønsteret.
English: Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and
Danish: Øvrige bivirkninger i kliniske undersøgelser havde samme incidens hos Trazec-behandlede som hos
English: Important information about some of the ingredients of Trazec Trazec tablets contain lactose monohydrate.
Danish: Vigtige oplysninger om visse af indholdsstofferne i Trazec Trazec indeholder lactosemonohydrat.
English: The systemic availability and half-life in dialysis-dependent diabetic patients was comparable with healthy subjects.
Danish: Den systemiske tilgængelighed og halveringstiden hos dialysekrævende diabetikere kunne sammenlignes med raske personer.
English: In type 2 diabetic patients given Trazec over the dose range 60 to 240 mg before three meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and
Danish: Hos type 2 diabetikere, der indtager en dosis på 60-240 mg før tre måltider dagligt i en uge, viste nateglinid's lineære farmakokinetiske egenskaber for både AUC og Cmax, og tmax var uafhængig