FrancophonIA/ELRC3.0 huggingface dataset:
English: If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, 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 Xiliarx, må du ikke tage medicinen, men skal henvende dig til din læge.
English: Xiliarx contains lactose (milk sugar).
Danish: Xiliarx indeholder lactose (mælkesukker).
English: Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Xiliarx therapy is recommended.
Danish: Hvis en øgning i ASAT eller ALAT på 3x ULN eller derover varer ved, anbefales seponering af Xiliarx.
English: Adverse reactions reported in patients who received Xiliarx 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 Xiliarx som monoterapi i dobbeltblindede studier og tillægsbehandlinger, er opført nedenfor for hver indikation efter organsystemklasse og absolut hyppighed.
English: • if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for vildagliptin eller et af de øvrige indholdsstoffer i Xiliarx (angivet i pkt.
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Xiliarx.
Danish: Patienter, der udvikler gulsot eller andre symptomer, som tyder på leverdysfunktion, bør ophøre behandling med Xiliarx.
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Danish: • 100 mg daglig som 50 mg om morgenen og 50 mg om aftenen, hvis du tager Xiliarx alene, sammen med anden medicin kaldet metformin eller et glitazon, sammen med en kombination af metformin og et sulfonylurinstof eller sammen med insulin.
English: When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Danish: Når Xiliarx anvendes som monoterapi, i kombination med metformin, i kombination med glitazon, i kombination med metformin og et sulfonylurinstof eller i kombination med insulin (med eller uden metformin), er den anbefalede daglige dosis af vildagliptin 100 mg, administreret som én dosis på 50 mg om morgenen og én dosis på 50 mg om aftenen.
English: How Xiliarx works
Danish: Hvordan Xiliarx virker
English: You should not use Xiliarx if you are breast-feeding or plan to breast-feed.
Danish: Du må ikke tage Xiliarx, hvis du ammer eller planlægger at amme.
English: • if you are taking an anti-diabetic medicine known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Xiliarx in order to avoid low blood glucose [hypoglycaemia]).
Danish: • hvis du tager medicin mod diabetes, kaldet sulfonylurinstof (for at undgå at du får lavt blodsukker [hypoglykæmi], vil din læge måske nedsætte din dosis af sulfonylurinstoffet, når du tager det sammen med Xiliarx).
English: What Xiliarx looks like and contents of the pack Xiliarx 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Danish: Xiliarx 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: Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Danish: Xiliarx må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har alanin-aminotransferase (ALAT) eller aspartat-aminotransferase (ASAT) > 3x den øvre normale grænseværdi (ULN) (se også pkt.
English: Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Danish: Xiliarx 50 mg tabletter fås i pakninger med 7, 14, 28, 30, 56, 60, 90, 112, 180 eller 336 tabletter samt i multipakninger bestående af 3 pakker, som hver indeholder 112 tabletter.
English: Some patients have had the following side effects while taking Xiliarx and insulin (with or without metformin):
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx og insulin (med eller uden metformin):
English: A test to determine your liver function will be performed before the start of Xiliarx treatment, at threemonth intervals for the first year and periodically thereafter.
Danish: Du vil få taget en blodprøve til undersøgelse af din leverfunktion, før du starter med Xiliarxbehandlingen, med tre måneders interval i det første år og derefter regelmæssigt.
English: You should not use Xiliarx during pregnancy.
Danish: Du må ikke tage Xiliarx under graviditet.
English: • 50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine called a sulphonylurea.
Danish: • 50 mg daglig, som du tager på én gang om morgenen, hvis du tager Xiliarx sammen med anden medicin, kaldet sulfonylurinstof.
English: If a dose of Xiliarx is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis af Xiliarx glemmes, skal den tages så snart patienten kommer i tanke om det. En dobbeltdosis bør ikke tages på samme dag.
English: • Uncommon: Constipation
Danish: • Almindelig: Svimmelhed
English: Children and adolescents The use of Xiliarx in children and adolescents up to 18 years of age is not recommended.
Danish: Børn og unge Xiliarx anbefales ikke til børn og unge under 18 år.
English: Xiliarx is not recommended for use in children and adolescents under (< 18 years).
Danish: Xiliarx bør ikke anvendes til børn og unge (< 18 år).
English: If you stop taking Xiliarx
Danish: Hvis du holder op med at tage Xiliarx
English: When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.
Danish: Når Xiliarx kombineres med et sulfonylurinstof, er den anbefalede dosis af vildagliptin 50 mg én gang daglig om morgenen.
English: If you forget to take Xiliarx
Danish: Hvis du har glemt at tage Xiliarx
English: At the end of the study, effect on mean body weight was neutral (+0.6 kg in the vildagliptin group and -0.1 kg in the placebo group).
Danish: Ved afslutningen af studiet var virkningen på gennemsnits-kropsvægten neutral (+0,6 kg i vildagliptingruppen og -0,1 kg i placebo-gruppen).
English: Therefore Xiliarx should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Danish: Derfor skal Xiliarx anvendes med forsigtighed til disse patienter (se også pkt.
English: Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2).
Danish: Xiliarx må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN (se også pkt.
English: What you need to know before you take Xiliarx
Danish: Det skal du vide, før du begynder at tage Xiliarx
English: Xiliarx should not be used during breast-feeding.
Danish: Xiliarx bør ikke anvendes under amning.
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Xiliarx 100 mg daily were 1.4 and 2.7 kg, respectively.
Danish: I pioglitazon-tillægsstudiet var den absolutte vægtstigning 1,4 for placebo og 2,7 kg for Xiliarx 100 mg daglig.
English: Xiliarx contains lactose
Danish: Xiliarx indeholder lactose
English: Some patients have had the following side effects while taking Xiliarx, metformin and a sulphonylurea:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx, metformin og et sulfonylurinstof:
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Xiliarx is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Danish: Hos patienter med moderat til svært nedsat nyrefunktion eller med nyresygdom i sidste stadie (end-stage renal disease: ESRD) er den anbefalede dosis 50 mg én gang daglig (se også pkt.
English: Xiliarx 50 mg tablets
Danish: Xiliarx 50 mg tabletter
English: Xiliarx 50 mg tablets vildagliptin
Danish: Xiliarx 50 mg tabletter vildagliptin
English: The amount of Xiliarx people have to take varies depending on their condition.
Danish: Så meget Xiliarx skal du tage, og hvornår du skal tage det Den mængde Xiliarx, du skal tage, afhænger af din sygdomstilstand.
English: Table 5 Adverse reactions reported in patients who received Xiliarx 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Danish: Tabel 5 Bivirkninger, der blev rapporteret hos patienter, der fik Xiliarx 50 mg to gange dagligt i kombination med metformin og et sulfonylurinstof (N=157)
English: Table 6 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Danish: Tabel 6 Bivirkninger, der blev rapporteret hos patienter, der fik Xiliarx 100 mg dagligt i kombination med insulin (med eller uden metformin) i dobbeltblindede studier (N=371)
English: How long to take Xiliarx
Danish: Så længe skal du tage Xiliarx
English: • Uncommon: Diarrhoea, flatulence
Danish: • Ikke almindelige: Diare, luftafgang fra tarmen
English: The usual dose of Xiliarx is either:
Danish: Den sædvanlige dosis er:
English: Table 1 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with metformin in double-blind studies (N=208)
Danish: Tabel 1 Bivirkninger rapporteret hos patienter, der fik Xiliarx 100 mg daglig i kombination med metformin i dobbeltblindede studier (N=208)
English: • Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating
Danish: • Almindelige: Svimmelhed, rysten, svaghed, lavt blodsukker, øget svedtendens
English: Other side effects Some patients have had the following side effects while taking Xiliarx and metformin:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx og metformin:
English: Table 4 Adverse reactions reported in patients who received Xiliarx 100 mg daily as monotherapy in double-blind studies (N=1,855)
Danish: Tabel 4 Bivirkninger rapporteret hos patienter, der fik Xiliarx 100 mg daglig som monoterapi i dobbeltblindede studier (N=1.855)
English: How to take Xiliarx
Danish: Sådan skal du tage Xiliarx
English: In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of
Danish: Hos patienter med svært nedsat nyrefunktion reducerede vildagliptin HbA1c-værdien signifikant sammenlignet med placebo (difference på -0,56 %) fra en gennemsnitlig baseline-værdi på 7,7 %.
English: Table 2 Adverse reactions reported in patients who received Xiliarx 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Danish: Tabel 2 Bivirkninger rapporteret hos patienter, der fik Xiliarx 50 mg daglig i kombination med et sulfonylurinstof i dobbeltblindede studier (N=170)
English: What Xiliarx is and what it is used for What you need to know before you take Xiliarx How to take Xiliarx
Danish: Det skal du vide, før du begynder at tage Xiliarx Sådan skal du tage Xiliarx Bivirkninger
English: What Xiliarx contains
Danish: Xiliarx indeholder:
English: Table 3 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Danish: Tabel 3 Bivirkninger rapporteret hos patienter, der fik Xiliarx 100 mg daglig i kombination med et glitazon i dobbeltblindede studier (N=158)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Xiliarx Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: EU/1/08/486/011 336 tablets (3 packs of 112)
Danish: 336 tabletter (3 pakker a 112)
English: Some patients have had the following side effects while taking Xiliarx alone: • Common: Dizziness
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Xiliarx alene:
English: • Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose Some patients have had the following side effects while taking Xiliarx and a glitazone:
Danish: • Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): Ondt i halsen, løbende næse
English: 23 June 2014 EMA/427574/2014
Danish: Den 23. juni 2014 EMA/427574/2014
English: Zolpidem has been authorised via national procedures in all Member States of the EU.
Danish: Zolpidem er godkendt via nationale procedurer i alle EU's medlemsstater.
English: The review of zolpidem-containing medicines was initiated on 4 July 2013 at the request of the Italian Medicines Agency (AIFA) under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende zolpidem blev indledt den 4. juli 2013 på anmodning af den italienske lægemiddelstyrelse (AIFA) i henhold til artikel 31 i direktiv 2001/83/EF.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Disse oplysninger blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: Warnings have been introduced to the product information to highlight these risks.
Danish: Der er indsat advarsler i produktinformationen for at fremhæve disse risici.
English: A neurotransmitter is a chemical that carries signals between nerve cells.
Danish: En neurotransmitter er et kemisk stof, der overfører signaler mellem nerveceller.
English: Information to healthcare professionals
Danish: Information til sundhedspersonale
English: • Patients who have any concerns about their treatment should speak to their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål til deres behandling, bør kontakte deres læge eller apotek.
English: In order to minimise this risk, zolpidem should not be re-taken during the same night.
Danish: For at minimere denne risiko må zolpidem ikke tages igen samme nat.
English: By stimulating the receptor, zolpidem is able to enhance this effect, helping patients to sleep.
Danish: Ved at stimulere receptoren forstærker zolpidem denne virkning, så patienten lettere falder i søvn.
English: Changes made to the product information of zolpidem-containing medicines include strengthened warnings and precautions.
Danish: Ændringerne i produktinformationen for lægemidler indeholdende zolpidem består i skærpede advarsler og forsigtighedsregler.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Danish: 1 CMD(h) er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater.
English: These recommendations are based on a careful assessment of the available data on the safety and efficacy of zolpidem from clinical studies, post-marketing reports and the published literature.
Danish: Disse anbefalinger er baseret på en nøje vurdering af de foreliggende data om sikkerheden og virkningen af zolpidem fra kliniske undersøgelser, indberetninger efter markedsføring og den videnskabelige litteratur.
English: Zolpidem is a medicine used for the short-term treatment of insomnia.
Danish: Zolpidem er et lægemiddel, der anvendes til korttidsbehandling af søvnløshed.
English: Furthermore, patients should not drive or perform activities that require mental alertness for at least 8 hours after taking zolpidem.
Danish: Desuden må patienten ikke føre motorkøretøj eller udføre aktiviteter, der kræver årvågenhed, i et tidsrum på mindst otte timer efter at have taget zolpidem.
English: This receptor is part of a system in the brain that normally responds to a neurotransmitter called gamma-aminobutyric acid (GABA) and which reduces the activity of the brain, causing relaxation and sleepiness.
Danish: Denne receptor hører til et system i hjernen, som normalt aktiveres af neurotransmitteren gammaaminosmørsyre (GABA), og som nedsætter hjerneaktiviteten og virker afslappende og søvndyssende.
English: On 24 April 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficulty sleeping).
Danish: Den 24. april 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h))1 ved en flertalsafgørelse nye anbefalinger om zolpidemholdige lægemidler, der anvendes til korttidsbehandling af søvnløshed.
English: As zolpidem-containing medicines are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 24 April 2014.
Danish: Da lægemidler indeholdende zolpidem alle er godkendt nationalt, blev PRAC's anbefalinger overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedurelægemidler til mennesker (CMD(h)), som vedtog et endeligt standpunkt den 24. april 2013.
English: • It is important that patients do not exceed the recommended dose of zolpidem, which is 10 mg by mouth once a day; a lower dose may be prescribed to some adults.
Danish: • Det er vigtigt, at patienten ikke overskrider den anbefalede dosis af zolpidem, dvs. 10 mg gennem munden én gang dagligt; nogle voksne kan dog få ordineret en lavere dosis.
English: It acts by attaching to and stimulating a particular type of receptor on nerve cells called the alpha-1 GABA-A receptor (also called the omega-1 receptor).
Danish: Det virker ved at stimulere alfa-1-GABA-A-receptoren (også kaldet omega-1-receptoren) i nervecellerne.
English: • Patients should take the lowest effective dose, in a single intake just before bedtime.
Danish: • Patienten skal tage den laveste effektive dosis som en enkelt dosis umiddelbart før sengetid.
English: The normal recommended daily dose in adults, which must not be exceeded, remains at 10 mg, and for older patients and patients with reduced liver function it remains at 5 mg.
Danish: Den normale anbefalede daglige dosis hos voksne er fortsat på 10 mg og må ikke overskrides, og hos ældre patienter og patienter med nedsat leverfunktion er den fortsat 5 mg.
English: Some studies showed an association between intake of zolpidem in the middle of the night and impaired driving ability the next day.
Danish: Nogle undersøgelser viste sammenhæng mellem indtagelse af zolpidem midt om natten og nedsat evne til at føre motorkøretøj den påfølgende dag.
English: • Patients taking zolpidem should make sure there is a period of at least 8 hours between taking the medicine and driving or operating other machinery.
Danish: • Patienter, som tager zolpidem, skal sikre, at der går mindst otte timer, fra de tager lægemidlet, til de fører motorkøretøj eller betjener maskiner.
English: These recommendations followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety of zolpidem with regards to the risk of impaired driving, somnambulism, and reduced mental alertness (such as drowsiness and slower reactions) after taking the medicine, and information on its effectiveness at lower doses.
Danish: Disse anbefalinger blev fremsat efter, at EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) havde gennemgået dels de foreliggende data om sikkerheden af zolpidem med henblik på risikoen for nedsat evne til at føre motorkøretøj, søvngængeri og nedsat årvågenhed (såsom døsighed og nedsat reaktionsevne) efter indtagelse af lægemidlet, dels oplysninger om dets effektivitet i lavere doser.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Danish: Eftersom CMD(h) vedtog sit standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende afgørelse for hele EU den 23. juni 2014.
English: • The daily dose of zolpidem remains 10 mg a day in adults and 5 mg a day in the elderly and in patients with hepatic impairment; this dose must not be exceeded.
Danish: • Den daglige dosis af zolpidem er fortsat 10 mg dagligt til voksne og 5 mg dagligt til ældre og patienter med nedsat leverfunktion; disse doser må ikke overskrides.
English: The data analysed during the review showed that, while most cases of impaired driving were linked to the intake of a 10 mg daily dose of zolpidem, lower doses were not shown to significantly reduce the risk of impaired driving and were not consistently shown to be effective at population level.
Danish: Gennemgangen at dataene viste, at nedsat evne til at føre motorkøretøj oftest forekom ved en daglig dosis zolpidem på 10 mg, men at lavere doser ikke indebærer væsentligt mindre risiko for nedsat evne til at føre motorkøretøj, og på populationsniveau har det ikke været muligt konsekvent at påvise, at lavere doser er effektive.
English: Patients should take the lowest effective dose of zolpidem in a single intake just before going to bed and should not take another dose during the same night.
Danish: Patienten skal tage den laveste effektive dosis af zolpidem som en enkelt dosis umiddelbart før sengetid, og indtagelsen må ikke gentages samme nat.
English: • The risk of impaired mental alertness also increases if zolpidem is taken at higher than recommended doses, or if it is co-administered with other CNS depressants, alcohol, or illicit drugs.
Danish: • Risikoen for nedsat årvågenhed er ligeledes større, hvis zolpidem tages i højere doser end de anbefalede, eller tages sammen med andre CNS-depressiva, alkohol eller narkotika.
English: The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes have been made to the product information to minimise the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use.
Danish: CMD(h) fandt, at benefit/riskforholdet for disse lægemidler fortsat er positivt, men der er foretaget ændringer i produktinformationen for at mindske den kendte risiko for nedsat årvågenhed og evne til at føre motorkøretøj og betjene maskiner morgenen efter anvendelse af lægemidlet.
English: • Zolpidem-containing medicines are used for the short-term treatment of insomnia (difficulty sleeping).
Danish: • Lægemidler indeholdende zolpidem anvendes til korttidsbehandling af søvnløshed.
English: Since the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the central nervous system (brain and spinal cord), or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Danish: Risikoen for nedsat evne til at føre motorkøretøj er tilsyneladende større, hvis zolpidem tages sammen med andre lægemidler, der påvirker hjernen og rygmarven (centralnervesystemet), eller sammen med alkohol eller narkotika.
English: • Since the risk of reduced mental alertness and driving ability seems to increase if zolpidem is taken together with other medicines that cause drowsiness or lack of alertness, or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Danish: • Tilsyneladende er risikoen øget for nedsat årvågenhed og evne til at føre motorkøretøj, hvis zolpidem tages sammen med andre lægemidler, der forårsager døsighed og nedsat årvågenhed, eller sammen med alkohol eller narkotika.