FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections, including PML and opportunistic infections […] The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4).
Danish: Infektioner, inklusive PML og opportunistiske infektioner […] Varigheden af behandlingen med TYSABRI inden frembrud af infektion var mellem nogle få måneder og indtil flere år (se pkt.
English: Tell your doctor straight away if you have any of the following side effects…:
Danish: Fortæl det straks til lægen, hvis du bemærker en eller flere af følgende bivirkninger:
English: Natalizumab - Necrotising retinitis (EPITT no 18605)
Danish: Natalizumab - Nekrotiserende retinitis (EPITT nr. 18605)
English: Section 4.4 - Special warnings and precautions for use Infections including other opportunistic infections
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Infektioner, inklusive andre opportunistiske infektioner
English: […] If herpes encephalitis or meningitis occurs, TYSABRI should be discontinued and appropriate treatment for herpes encephalitis or meningitis should be administered.
Danish: […] Hvis herpes encephalitis eller meningitis opstår, skal TYSABRI seponeres og passende behandling for herpes encephalitis eller meningitis skal administreres.
English: Section 4.8 - Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘not known': Calciphylaxis
Danish: Punkt 4.8 - Bivirkninger Hud og subkutane væv Hyppighed "Ikke kendt": Kalcifylaksi
English: This adverse reaction occurs more frequently in patients with chronic kidney disease.
Danish: Denne bivirkning optræder hyppigere hos patienter med kronisk nyresygdom.
English: The condition is mainly observed in patients with end-stage renal disease on dialysis or in patients with known risk factors such as protein C or S deficiency, hyperphosphataemia, hypercalcaemia or hypoalbuminaemia.
Danish: Tilstanden ses hovedsageligt hos dialysepatienter i slutstadiet af deres nyresygdom eller hos patienter med kendte risikofaktorer såsom protein C- eller protein S-mangel, hyperfosfatæmi, hyperkalcæmi eller hypoalbuminæmi.
English: Patients presenting with eye symptoms such as decreased visual acuity, redness and painful eye should be referred for retinal screening for ARN.
Danish: Patienter med øjenrelaterede symptomer såsom nedsat synsskarphed, røde øjne og øjensmerter bør henvises til nethindescreening for ARN.
English: The treatment reported in these cases included antiviral therapy and in some cases, surgery (see section 4.4).
Danish: Den rapporterede behandling i disse tilfælde omfattede antiviral behandling og i enkelte tilfælde kirurgiske indgreb (se pkt.
English: Acute retinal necrosis (ARN) is a rare fulminant viral infection of the retina caused by the family of herpes viruses (e.g. varicella zoster).
Danish: Akut retinal nekrose (ARN) er en sjælden fulminant virusinfektion i nethinden forårsaget af herpesviridae-familien (f.eks. varicella zoster).
English: On rare occasions warfarin can cause serious skin conditions, including one called calciphylaxis that can start with a painful skin rash but can lead to other serious complications.
Danish: I sjældne tilfælde kan warfarin forårsage sjældne hudlidelser, herunder kalcifylaksi, som kan begynde med smertende udslæt og sidenhen medføre alvorlige komplikationer.
English: In post-marketing experience, rare cases of acute retinal necrosis (ARN) have been observed in patients receiving TYSABRI.
Danish: Efter markedsføringen er der observeret sjældne tilfælde af akut retinal nekrose (ARN) hos patienter i behandling med TYSABRI.
English: In case calciphylaxis is diagnosed, appropriate treatment should be started and consideration should be given to stopping treatment with warfarin.
Danish: Ved diagnosticering af kalcifylaksi bør passende behandling indledes, og seponering af warfarin overvejes.
English: Calciphylaxis is a rare syndrome of vascular calcification with cutaneous necrosis, associated with high mortality.
Danish: Kalcifylaksi er et sjældent syndrom, som forårsager vaskulær forkalkning og kutan nekrose forbundet med høj dødelighed.
English: A painful skin rash.
Danish: Smertende udslæt.
English: Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis).
Danish: Nogle tilfælde er observeret hos patienter med herpesinfektioner i centralnervesystemet (f.eks. meningitis og encephalitis forårsaget af herpesvirus).
English: • Impaired vision • Pain or redness of the eye(s)
Danish: • Nedsat synsskarphed • Røde øjne eller øjensmerter
English: Following clinical diagnosis of ARN, discontinuation of TYSABRI should be considered in these patients.
Danish: Efter klinisk diagnosticering af ARN bør seponering af TYSABRI overvejes.
English: Rare cases of calciphylaxis have been reported in patients taking warfarin, also in the absence of renal disease.
Danish: Der er rapporteret om sjældne tilfælde af kalcifylaksi hos patienter i behandling med warfarin, også hos patienter uden nyresygdom.
English: ARN has been observed in patients being administered TYSABRI and can be potentially blinding.
Danish: ARN kan føre til blindhed og er observeret hos patienter i behandling med TYSABRI.
English: 5 ml (50 mg/ml) 2 pre-filled syringes + 2 safety needles
Danish: 5 ml (50 mg/ml) 2 fyldte injektionssprøjter + 2 beskyttede kanyler
English: 5 ml (50 mg/ml) 1 pre-filled syringe + 1 safety needle
Danish: 5 ml (50 mg/ml) 1 fyldt injektionssprøjte + 1 beskyttet kanyle
English: Content (concentration)
Danish: Stryrke Lægemiddelform Administration Emballage Indhold (koncentration)
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in calves.
Danish: * Relativ styrke bestemt ved en styrketest med mus, som blev sammenlignet med referencevaccine, der blev vist virksom hos kvæg.
English: Withdrawal period hydrolytic glass vials type I (EP) with butyl stopper (EP) and aluminium seal
Danish: Intramuskulær Type I hydrolytisk hætteglas af glas (EP) med butylprop og (EP) aluminiumsh ætte
English: Pharmaceutical Form
Danish: SærnavnStyrke Lægemiddel form
English: Packaging Content Package size
Danish: Emballage Indhold Pakningsst ørrelse
English: Strength
Danish: Indgivelsesv ej
English: Route of administration
Danish: Tilbageho ldelsestid
English: Both treatments were well tolerated.
Danish: Begge behandlinger var veltolererede.
English: Take care: - if you are over 65 years of age.
Danish: Vær forsigtig: - hvis du er over 65 år.
English: Its effect may be delayed if it is taken during or after meals.
Danish: Dets virkning kan forsinkes, hvis det tages under eller efter et måltid.
English: Swallow the tablets whole with a glass of water.
Danish: Synk tabletterne hele, med et glas vand.
English: - if you have drunk alcohol.
Danish: - hvis du har drukket alkohol.
English: Date of first authorisation: 03 April 2001 Date of latest renewal: 24 April 2006
Danish: Dato for første markedsføringstilladelse: 03 april 2001 Dato for seneste fornyelse: 24 april 2006
English: Starlix can be used by people over 65 years of age.
Danish: Starlix kan anvendes af personer over 65 år.
English: Elderly The clinical experience in patients over 75 years of age is limited.
Danish: Ældre Den kliniske erfaring med patienter over 75 år er begrænset.
English: • Type 1 diabetes (C-peptide negative)
Danish: • Type 1-diabetes (C-peptid-negativ)
English: Bear this in mind if you drive a car or operate machines as you might put yourself or others at risk.
Danish: Hav dette i tankerne, hvis du skal køre bil eller betjene maskiner, da du kan udsætte dig selv eller andre for fare.
English: +ATP channels.
Danish: +ATP-kanaler.
English: - if you are due to have an operation.
Danish: - hvis du skal opereres.
English: - if you have recently suffered a fever, an accident or an infection.
Danish: - hvis du for nylig har haft feber, har været ude for en ulykke eller har haft en infektion.
English: Medical attention may be necessary.
Danish: Det kan være nødvendigt med lægehjælp.
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: 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: Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Danish: Starlix anbefales ikke til børn og unge (under 18 år), da dets virkning i denne aldersgruppe ikke er blevet undersøgt.
English: Alcohol may disturb the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Starlix.
Danish: Alkohol kan forstyrre kontrollen af dit blodsukker, så du rådes til at tale med din læge vedrørende indtagelse af alkohol, mens du tager Starlix.
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: Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise programme your doctor has recommended for you.
Danish: Selvom om du er i behandling for din diabetes, er det vigtigt fortsat at følge diæten og/eller motionsprogrammet, som din læge har anbefalet dig.
English: Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar.
Danish: Fortsæt med at tage dette lægemiddel så længe din læge udskriver dette, sådan at det fortsat kan bidrage til at kontrollere dit blodsukker.
English: Approximately 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: Frequencies are defined as: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvenserne defineres således: Meget almindelig (1/10); almindelig (1/100 til <1/10); ikke almindelig (1/1.000 til <1/100); sjælden (1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndeværende data).
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: Et langtidsstudie med nateglinid er ikke blevet udført, og derfor er langtidsfordelene associeret med forbedret glykæmisk kontrol ikke blevet vist.
English: - if you are undernourished.
Danish: - hvis du er underernæret.
English: Such patients should take special care to avoid low blood sugar.
Danish: Disse patienter skal være særligt opmærksomme på at undgå lavt blodsukker.
English: • Diabetic ketoacidosis, with or without coma
Danish: • Diabetisk ketoacidose med eller uden koma
English: It helps to control the level of sugar in the blood.
Danish: Det hjælper med at kontrollere mængden af sukker i blodet.
English: The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be approximately 10 litres.
Danish: Nateglinids steady-state distributionsvolumen baseret på intravenøse data vurderes til ca. 10 liter.
English: - Somatropin (a growth hormone).
Danish: - Somatropin (væksthormon).
English: The dosage of nateglinide should be determined by the physician according to the patient's requirements.
Danish: Dosis af nateglinid afgøres af lægen på baggrund af patientens behov.
English: Starlix is used to treat adult patients with type 2 diabetes.
Danish: Starlix bruges til at behandle voksne patienter med type 2-diabetes.
English: Approximately 75% of the administered [
Danish: Ca. 75% af det indgivne
English: Starlix is contraindicated in patients with:
Danish: Starlix er kontraindiceret til patienter med:
English: Watch carefully for signs of low blood sugar, especially: - if you have exercised more strenuously than usual.
Danish: Hold nøje øje med symptomer på lavt blodtryk, især - hvis du har motioneret hårdere end normalt.
English: These symptoms 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: If you have type 2 diabetes, your body may not start producing insulin quickly enough after meals.
Danish: Hvis du har type 2-diabetes, begynder din krop måske ikke at producere insulin hurtigt nok, efter at du har spist.
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 foreligger ingen data om brugen af nateglinid til patienter under 18 år, og det anbefales derfor ikke til denne aldersgruppe.
English: CYP2C9 and CYP3A4 substrates
Danish: CYP2C9 og CYP3A4-substrater
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 måltiderne.
English: Take Starlix before the three main meals, usually: - 1 dose before breakfast - 1 dose before lunch - 1 dose before dinner
Danish: Starlix skal tages før de 3 hovedmåltider, normalt: - 1 dosis før morgenmaden - 1 dosis før frokosten - 1 dosis før aftensmaden
English: Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia).
Danish: Din evne til at koncentrere sig eller reagere kan være nedsat, hvis du har lavt blodsukker (hypoglykæmi).
English: Insulin is a substance produced in the body by the pancreas.
Danish: Insulin er et stof produceret af kroppen i bugspytkirtlen.
English: These include:
Danish: Disse symptomer omfatter:
English: Adults 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: Do not stop taking Starlix unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Starlix med mindre din læge beder dig om det.
English: Not all pack sizes or tablet strengths may be available in your country.
Danish: Ikke alle pakningstørrelser eller tabletstyrker er nødvendigvis markedsført i dit land.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørelser er nødvendigvis markedsført.
English: Other events
Danish: Andre hændelser
English: Do not take Starlix - if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Starlix - hvis du er allergisk over for nateglinid eller et af de øvrige indholdsstoffer (angivet i punkt 6).
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 dagligt.
English: There is no experience of an overdose of Starlix in clinical trials.
Danish: Der er ingen erfaring med overdosering af Starlix i kliniske undersøgelser.
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 mælk, kan der være risiko for hypoglykæmi hos det ammede barn, og nateglinid bør derfor ikke gives til ammende kvinder.
English: Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Danish: Selvom sikkerheden ikke var kompromiteret i denne population, kan dosisjustering være nødvendig set i lyset af den lave Cmax.
English: Starlix works by stimulating the pancreas to produce insulin more quickly, which helps to keep blood sugar levels under control after meals.
Danish: Starlix fungerer ved at stimulere bugspytkirtlen, så den producerer insulin hurtigere, og det bidrager til at holde dit blodsukker under kontrol efter måltiderne.
English: Take Starlix before meals.
Danish: Tag Starlix inden et måltid.
English: 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: Nateglinide is rapidly absorbed following oral administration of Starlix 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 Starlix tabletter før et måltid, og maksimal lægemiddelkoncentration optræder normalt inden for mindre end 1 time.
English: It is especially important that you tell your doctor, pharmacist or nurse if you are taking: - Non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain).
Danish: Det er især vigtigt, at du giver lægen, apotekspersonalet eller sundhedspersonalet besked, hvis du på nuværende tidspunkt tager: - Non-steroide antiinflammatoriske midler (bruges f.eks. til at behandle muskel- eller ledsmerter).
English: Your doctor may check the amount of Starlix that you are taking on a regular basis and may adjust the dose according to your needs.
Danish: Din læge vil muligvis regelmæssigt tjekke den mængde af Starlix du tager, og vil muligvis tilrette dosis i forhold til dine behov.
English: You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you are not aware of the first signs of hypoglycaemia.
Danish: Du skal spørge din læge til råds vedrørende bilkørsel, hvis du hyppigt har hypoglykæmi, eller hvis du ikke er opmærksom på de første symptomer på hypoglykæmi.
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully, even if they are different from what is in this leaflet.
Danish: Følg nøje alle instruktioner som du modtager fra lægen, apoteket eller sundhedspersonalet, også selvom de måske afviger fra oplysningerne i denne indlægsseddel.
English: Although M1 metabolites show only slight hypoglycaemic activity (approximately 5 times lower than nateglinide), metabolite accumulation might increase the hypoglycaemic effect of the administered dose.
Danish: Selvom M1-metabolitter kun udviser svag hypoglykæmisk aktivitet (omkring 5 gange lavere end nateglinid), kan akkumuleringen af metabolitter øge den hypoglykæmiske effekt af den administrerede dosis.
English: The extent of serum protein binding is independent of drug concentration over the test range of 0.1-10 g Starlix/ml.
Danish: Omfanget af serumproteinbindingen er uafhængigt af lægemiddelkoncentrationen i et testområde på 0,1-10 mikrogram Starlix/ml.
English: Insulin levels return to baseline within 3 to 4 hours, reducing post-meal hyperinsulinaemia.
Danish: Insulinniveauerne returnerer til udgangsniveauet i løbet af 3-4 timer og reducerer postprandial hyperinsulinæmi.
English: There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed.
Danish: Der er ingen erfaring med anvendelse af nateglinid til gravide kvinder, hvorfor Starlix' sikkerhed hos gravide kvinder ikke kan vurderes.
English: Do not take Starlix if you are pregnant or planning to become pregnant.
Danish: Tag ikke Starlix, hvis du er gravid eller planlægger at blive gravid.
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 omhyggeligt.
English: Electrophysiological studies demonstrate that nateglinide has 45-300-fold selectivity for pancreatic beta cell versus cardiovascular K
Danish: Elektrofysiologiske undersøgelser viser, at nateglinid har 45-300 gange større selektivitet for pankreatiske β-celler i forhold til kardiovaskulære K
English: - if you are experiencing any symptoms of severe hyperglycaemia (very high blood sugar and/or diabetic ketoacidosis).
Danish: - hvis du oplever symptomer på alvorlig hyperglykæmi (meget højt blodsukker og/eller diabetisk ketoacidose).
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: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder entydig identifikator.
English: Absolute oral bioavailability is estimated to be 72%.
Danish: Absolut oral biotilgængelighed estimeres til
English: Blisters: PVC/PE/PVDC blisters, backed with a heat-sealable lacquered aluminium foil.
Danish: Blisterpakninger: PVC/PE/PVDC blister bagbeklædt med varmeforseglet, lakeret aluminiumsfolie.
English: Nateglinide should not be used in monotherapy.
Danish: Nateglinid bør ikke anvendes som monoterapi.
English: • Very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes and/or mouth, sometimes with headache, fever and/or diarrhoea
Danish: • Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): hududslæt med blisterdannelse, som rammer læber, øjne og/eller mund, sommetider med hovedpine, feber og/eller diarré
English: Studies in animals have shown developmental toxicity (see section 5.3).
Danish: Dyrestudier har vist udviklingstoksicitet (se pkt.
English: In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Danish: I et klinisk studie med patienter blev Starlix indgivet i stigende doser indtil 720 mg dagligt i 7 dage, hvilket var veltoleret.
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 surt α1-glykoprotein.
English: Since the primary therapeutic effect of Starlix is to reduce mealtime glucose (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1-2 hour post-meal glucose.
Danish: Da den primære behandlingseffekt af Starlix er at reducere prandial glukose (som bidrager til HbA1c), kan den terapeutiske reaktion på Starlix også måles med 1-2 timer postprandial glukose.
English: Diabetic patients may develop symptoms associated with low blood sugar (also called hypoglycaemia).
Danish: Diabetikere kan udvikle symptomer som hænger sammen med lavt blodsukker (også kaldet hypoglykæmi).
English: As nateglinide is highly protein-bound, dialysis is not an efficient means of removing it from the blood.
Danish: Da nateglinid er kraftigt proteinbundet, elimineres det ikke effektivt fra blodet ved dialyse.
English: Talk to your doctor before taking Starlix - if you know that you have a liver problem.
Danish: Kontakt lægen, før du tager Starlix - hvis du ved, at du har en leverlidelse.
English: The side effects caused by Starlix are usually mild to moderate.
Danish: Bivirkningerne ved Starlix er normalt lette til moderate.
English: - Salicylates such as aspirin (used as painkillers).
Danish: - Salicylater så som aspirin (bruges som smertestillende midler).
English: Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03
Danish: Farmakoterapeutisk klassifikation: D-phenylalaninderivat, ATC-kode: A 10 BX 03