FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Telmisartan Teva Pharma, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Telmisartan Teva Pharma, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva Pharma on 3 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Telmisartan Teva Pharma den 3. oktober 2011.
English: pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: Hvis målet for blodtrykket ikke nås, kan dosis øges til 80 mg, eller der kan anvendes andre lægemidler mod forhøjet blodtryk, såsom hydrochlorothiazid, som tillægsbehandling.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Danish: Dette medfører, at blodtrykket falder, hvorved de risici, som er forbundet med forhøjet blodtryk, såsom hjertetilfælde eller slagtilfælde, reduceres.
English: Telmisartan Teva Pharma is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Danish: Telmisartan Teva Pharma anvendes også til forebyggelse af hjerte-kar-problemer (problemer med hjertet og blodkarrene), såsom hjertetilfælde og slagtilfælde.
English: This is a summary of the European Public Assessment Report (EPAR) for Telmisartan Teva Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Telmisartan Teva Pharma.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day
Danish: Patienter med mildt eller moderat nedsat leverfunktion bør ikke få højere dosis end 40 mg dagligt.
English: This means that Telmisartan Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Danish: Det betyder, at Telmisartan Teva Pharma er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Micardis.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva Pharma has been shown to have comparable quality and to be bioequivalent to Micardis.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Telmisartan Teva Pharma er af sammenlignelig kvalitet og er bioækvivalent med Micardis.
English: Telmisartan Teva Pharma is a medicine that contains the active substance telmisartan.
Danish: Telmisartan Teva Pharma et lægemiddel, der indeholder det aktive stof telmisartan.
English: Because Telmisartan Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Telmisartan Teva Pharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Telmisartan Teva Pharma is a ‘generic medicine'.
Danish: Telmisartan Teva Pharma er et "generisk lægemiddel".
English: Because Telmisartan Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Danish: Da Telmisartan Teva Pharma er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Micardis.
English: Other information about Telmisartan Teva Pharma:
Danish: Andre oplysninger om Telmisartan Teva Pharma
English: What are the benefit and risk of Telmisartan Teva Pharma?
Danish: Hvilken fordel og risiko er der forbundet med Telmisartan Teva Pharma?
English: Why has Telmisartan Teva Pharma been approved?
Danish: Hvorfor blev Telmisartan Teva Pharma godkendt?
English: The Committee recommended that Telmisartan Teva Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Telmisartan Teva Pharma.
English: How has Telmisartan Teva Pharma been studied?
Danish: Hvordan blev Telmisartan Teva Pharma undersøgt?
English: What is Telmisartan Teva Pharma?
Danish: Hvad er Telmisartan Teva Pharma?
English: How does Telmisartan Teva Pharma work?
Danish: Hvordan virker Telmisartan Teva Pharma?
English: How is Telmisartan Teva Pharma used?
Danish: Hvordan anvendes Telmisartan Teva Pharma?
English: What is Telmisartan Teva Pharma used for?
Danish: Hvad anvendes Telmisartan Teva Pharma til?
English: Date of first authorisation: 26 September 2007 Date of latest renewal: 23 July 2012
Danish: Dato for første markedsføringstilladelse: 26. september 2007 Dato for seneste fornyelse: 23. juli 2012
English: However, the magnitude of change is not clinically significant, so that Galvus can be given with or without food.
Danish: Men ændringens størrelse er ikke klinisk signifikant, så Galvus kan gives med eller uden mad.
English: How to take Galvus • Swallow the tablets whole with some water.
Danish: Hvordan du skal tage Galvus • Synk tabletterne hele med lidt vand.
English: • Take Galvus every day for as long as your doctor tells you.
Danish: • Tag Galvus hver dag, så længe din læge siger, at du skal gøre det.
English: Your doctor will tell you exactly how many tablets of Galvus to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange Galvustabletter du skal tage.
English: • if you have moderate or severe kidney disease (you will need to take a lower dose of Galvus).
Danish: • hvis du har en moderat eller alvorlig nyresygdom (det er nødvendigt, at du tager en lavere dosis af Galvus).
English: Some symptoms need immediate medical attention: You should stop taking Galvus and see your doctor immediately if you experience the following side effects:
Danish: Nogle symptomer kræver øjeblikkelig lægelig opmærksomhed: Du skal stoppe med at tage Galvus og straks kontakte din læge, hvis du oplever nogle af følgende bivirkninger:
English: Do not stop taking Galvus unless your doctor tells you to.
Danish: Hold ikke op med at tage Galvus, medmindre lægen siger det.
English: The active substance of Galvus, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Danish: Det aktive stof i Galvus, vildagliptin, tilhører en gruppe af lægemidler, der hedder ”orale antidiabetika”.
English: Do not take Galvus:
Danish: Tag ikke Galvus:
English: Galvus is not a substitute for insulin in insulin-requiring patients.
Danish: Galvus kan ikke erstatte insulin hos insulinkrævende patienter.
English: Talk to your doctor, pharmacist or nurse before taking Galvus
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Galvus
English: EU/1/07/414/001 7 tablets EU/1/07/414/002 14 tablets EU/1/07/414/003 28 tablets EU/1/07/414/004 30 tablets EU/1/07/414/005 56 tablets EU/1/07/414/006 60 tablets EU/1/07/414/007 90 tablets EU/1/07/414/008 112 tablets EU/1/07/414/009 180 tablets EU/1/07/414/010 336 tablets
Danish: EU/1/07/414/001 7 tabletter EU/1/07/414/002 14 tabletter EU/1/07/414/003 28 tabletter EU/1/07/414/004 30 tabletter EU/1/07/414/005 56 tabletter EU/1/07/414/006 60 tabletter EU/1/07/414/007 90 tabletter EU/1/07/414/008 112 tabletter EU/1/07/414/009 180 tabletter EU/1/07/414/010 336 tabletter
English: EU/1/07/414/018 336 tablets (3 packs of 112)
Danish: EU/1/07/414/018 336 tabletter (3 pakker a 112)
English: Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Galvus for 10 days.
Danish: Oplysningerne om de sandsynlige symptomer på overdosering er taget fra et studie af tolerabilitet af stigende doser hos raske forsøgspersoner, som fik Galvus i 10 dage.
English: Due to lack of human data, Galvus should not be used during pregnancy.
Danish: På grund af manglende data for mennesker bør Galvus ikke anvendes under graviditet.
English: If you take too many Galvus tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Danish: Hvis du tager for mange Galvus tabletter, eller hvis en anden har taget din medicin, skal du straks kontakte din læge.
English: Liver function tests should be performed prior to the initiation of treatment with Galvus in order to know the patient's baseline value.
Danish: Leverfunktionstest skal udføres før initiering af behandling med Galvus for at kende patientens baseline-værdi.
English: How Galvus works
Danish: Hvordan Galvus virker
English: Your doctor may wish to alter your dose of Galvus if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids (generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Danish: Din læge vil muligvis ønske at ændre din Galvus-dosis, hvis du tager anden medicin såsom: - thiazider eller andre diuretika (også kaldet vanddrivende tabletter) - kortikosteroider (bruges normalt til at behandle betændelseslignende reaktioner) - medicin, der påvirker skjoldbruskkirtlen - visse typer medicin, der påvirker nervesystemet.
English: Your doctor will prescribe Galvus either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Danish: Din læge kan ordinere Galvus enten alene eller sammen med visse andre typer medicin mod sukkersyge, som du allerede tager, hvis disse har vist sig ikke at være tilstrækkeligt effektive til at kontrollere sukkersygen.
English: No studies on the effect on human fertility have been conducted for Galvus (see section 5.3).
Danish: Der er ikke udført studier vedrørende Galvus virkning på human fertilitet (se pkt.
English: Oral use Galvus can be administered with or without a meal (see also section 5.2).
Danish: Oral anvendelse Galvus kan tages med eller uden mad (se også pkt.
English: • Do not use any Galvus pack that is damaged or shows signs of tampering.
Danish: • Brug ikke Galvus, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Galvus bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Liver function should be monitored during treatment with Galvus at three-month intervals during the first year and periodically thereafter.
Danish: Leverfunktionen skal monitoreres under behandling med Galvus med 3 måneders interval i det første år og derefter regelmæssigt.
English: It is not known if Galvus passes into breast milk.
Danish: Der er uvist om Galvus passerer ind i modermælken.
English: Following withdrawal of treatment with Galvus and LFT normalisation, treatment with Galvus should not be reinitiated.
Danish: Efter behandlingsophør med Galvus og normalisering af leverfunktion, bør behandling med Galvus ikke genoptages.
English: Driving and using machines If you feel dizzy while taking Galvus, do not drive or use machines.
Danish: Trafik- og arbejdssikkerhed Hvis du føler dig svimmel, når du tager Galvus, må du ikke køre bil eller betjene maskiner.
English: Galvus works by making the pancreas produce more insulin and less glucagon.
Danish: Galvus virker ved at få bugspytkirtlen til at producere mere insulin og mindre glucagon.
English: • Uncommon (may affect up to 1 in 100 people): Tiredness
Danish: • Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): Træthed
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Galvus.
Danish: Du bør også være særlig opmærksom på nye vabler eller sår, som du får, mens du tager Galvus.
English: Adverse reactions reported in patients who received Galvus 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 Galvus som monoterapi i dobbeltblindede studier og tillægsbehandlinger, er opført nedenfor for hver indikation efter organsystemklasse og absolut hyppighed.
English: The usual dose of Galvus is either:
Danish: Den sædvanlige dosis er:
English: Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Galvus therapy is recommended.
Danish: Hvis en øgning i ASAT eller ALAT på 3x ULN eller derover varer ved, anbefales seponering af Galvus.
English: The safety and efficacy of Galvus in children and adolescents (< 18 years) have not been established.
Danish: Galvus' sikkerhed og virkning hos børn og unge (< 18 år) er ikke klarlagt.
English: You should not use Galvus during pregnancy.
Danish: Du må ikke tage Galvus under graviditet.
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 Galvus (angivet i pkt.
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus 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 Galvus alene, sammen med anden medicin kaldet metformin eller et glitazon, sammen med en kombination af metformin og et sulfonylurinstof eller sammen med insulin.
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Galvus.
Danish: Patienter, der udvikler gulsot eller andre symptomer, som tyder på leverdysfunktion, bør ophøre behandling med Galvus.
English: Galvus is used to treat adult patients with type 2 diabetes.
Danish: Galvus bruges til at behandle voksne patienter med type 2-diabetes (sukkersyge).
English: If you stop taking Galvus
Danish: Hvis du holder op med at tage Galvus
English: Galvus contains lactose (milk sugar).
Danish: Galvus indeholder lactose (mælkesukker).
English: You should not use Galvus if you are breast-feeding or plan to breast-feed.
Danish: Du må ikke tage Galvus, hvis du ammer eller planlægger at amme.
English: Galvus is not recommended for use in children and adolescents (< 18 years).
Danish: Galvus bør ikke anvendes til børn og unge (< 18 år).
English: If you think you may be allergic to vildagliptin or any of the other ingredients of Galvus, 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 Galvus, må du ikke tage medicinen, men skal henvende dig til din læge.
English: Placebo-corrected mean change in HbA1c (%) at week 24 (95% CI)
Danish: Placebokorrigeret gennemsnitlig ændring i HbA1c (%) ved uge 24 (95 % CI)
English: If you forget to take Galvus
Danish: Hvis du har glemt at tage Galvus
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 Galvus 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 Galvus).
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 Galvus 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: Children and adolescents The use of Galvus in children and adolescents up to 18 years of age is not recommended.
Danish: Børn og unge Galvus anbefales ikke til børn og unge under 18 år.
English: What Galvus looks like and contents of the pack Galvus 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Danish: Galvus 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: A test to determine your liver function will be performed before the start of Galvus treatment, at three-month intervals for the first year and periodically thereafter.
Danish: Du vil få taget en blodprøve til undersøgelse af din leverfunktion, før du starter med Galvusbehandlingen, med tre måneders interval i det første år og derefter regelmæssigt.
English: Galvus 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: Galvus 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: If a dose of Galvus is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis af Galvus glemmes, skal den tages så snart patienten kommer i tanke om det. En dobbeltdosis bør ikke tages på samme dag.
English: Galvus 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: Galvus må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN (se også pkt.4.2 og 5.2).
English: Galvus 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: Galvus 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: Some patients have had the following side effects while taking Galvus and insulin (with or without metformin):
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus og insulin (med eller uden metformin):
English: Galvus 50 mg tablets
Danish: Galvus 50 mg tabletter
English: • 50 mg daily taken as one dose in the morning if you are taking Galvus with another medicine called a sulphonylurea.
Danish: • 50 mg daglig, som du tager på én gang om morgenen, hvis du tager Galvus sammen med anden medicin, kaldet sulfonylurinstof.
English: Galvus contains lactose
Danish: Galvus indeholder lactose
English: What you need to know before you take Galvus
Danish: Det skal du vide, før du begynder at tage Galvus
English: • Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose
Danish: • Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): Ondt i halsen, løbende næse
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 Galvus kombineres med et sulfonylurinstof, er den anbefalede dosis af vildagliptin 50 mg én gang daglig om morgenen.
English: Galvus should not be used during breast-feeding.
Danish: Galvus bør ikke anvendes under amning.
English: Galvus 50 mg tablets vildagliptin
Danish: Galvus 50 mg tabletter vildagliptin
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus 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 Galvus 100 mg daglig.
English: Some patients have had the following side effects while taking Galvus alone:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus alene:
English: Therefore Galvus should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Danish: Derfor skal Galvus anvendes med forsigtighed til disse patienter (se også pkt.
English: How long to take Galvus
Danish: Så længe skal du tage Galvus
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Galvus 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: The amount of Galvus people have to take varies depending on their condition.
Danish: Så meget Galvus skal du tage, og hvornår du skal tage det Den mængde Galvus, du skal tage, afhænger af din sygdomstilstand.
English: Table 5 Adverse reactions reported in patients who received Galvus 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Danish: Tabel 5 Bivirkninger, der blev rapporteret hos patienter, der fik Galvus 50 mg to gange dagligt i kombination med metformin og et sulfonylurinstof (N=157)
English: Table 6 Adverse reactions reported in patients who received Galvus 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 Galvus 100 mg dagligt i kombination med insulin (med eller uden metformin) i dobbeltblindede studier (N=371)
English: Some patients have had the following side effects while taking Galvus, metformin and a sulphonylurea:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus, metformin og et sulfonylurinstof:
English: Some patients have had the following side effects while taking Galvus and metformin:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus og metformin:
English: How to take Galvus
Danish: Sådan skal du tage Galvus
English: Some patients have had the following side effects while taking Galvus and a glitazone:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus og et glitazon:
English: Table 1 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with metformin in double-blind studies (N=208)
Danish: Tabel 1 Bivirkninger rapporteret hos patienter, der fik Galvus 100 mg daglig i kombination med metformin i dobbeltblindede studier (N=208)
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 Galvus Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Table 4 Adverse reactions reported in patients who received Galvus 100 mg daily as monotherapy in double-blind studies (N=1,855)
Danish: Tabel 4 Bivirkninger rapporteret hos patienter, der fik Galvus 100 mg daglig som monoterapi i dobbeltblindede studier (N=1.855)
English: What Galvus is and what it is used for What you need to know before you take Galvus How to take Galvus
Danish: Det skal du vide, før du begynder at tage Galvus Sådan skal du tage Galvus Bivirkninger
English: Table 2 Adverse reactions reported in patients who received Galvus 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Danish: Tabel 2 Bivirkninger rapporteret hos patienter, der fik Galvus 50 mg daglig i kombination med et sulfonylurinstof i dobbeltblindede studier (N=170)
English: What Galvus contains
Danish: Galvus indeholder:
English: Some patients have had the following side effects while taking Galvus and a sulphonylurea:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Galvus og et sulfonylurinstof: