FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Fiasp (which may affect more than 1 in 10 people) is hypoglycaemia (excessively low blood sugar).
Danish: Den hyppigste bivirkning ved Fiasp (som kan forekomme hos op til 1 ud af 10 personer) er for lavt blodsukker (hypoglykæmi).
English: An overview of Fiasp and why it is authorised in the EU
Danish: En oversigt over Fiasp, og hvorfor det er godkendt i EU
English: When injected under the skin, Fiasp should be used in combination with an intermediate- or long-acting insulin that is given at least once a day.
Danish: Når Fiasp injiceres under huden, bør det anvendes i kombination med et mellemtids- eller langtidsvirkende insulin, der gives mindst én gang om dagen.
English: It contains the active substance insulin aspart, a rapid-acting insulin.
Danish: Det indeholder det aktive stof insulin aspart, der er et hurtigtvirkende insulin.
English: For more information about using Fiasp, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Fiasp, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The overall rate and severity of side effects was comparable with NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp.
Danish: Den overordnede forekomst og sværhedsgraden af bivirkningerne var sammenlignelig med NovoRapid, men hypoglykæmi forekom dog hyppigere i de første to timer efter indgivelse af en dosis Fiasp.
English: Both Fiasp and NovoRapid contain insulin aspart but Fiasp contains some different ingredients intended to help it to be absorbed rapidly.
Danish: Både Fiasp og NovoRapid indeholder insulin aspart, men Fiasp indeholder en række andre ingredienser, der hjælper det med at blive hurtigt optaget i kroppen.
English: The dose depends on the patient's blood glucose, which should be tested regularly to find the dose that gives good control of blood sugar.
Danish: Dosen afhænger af patientens blodsukker, der skal kontrolleres regelmæssigt for at fastsætte den dosis, der giver den bedste regulering af blodsukkeret.
English: What is Fiasp and what is it used for?
Danish: Hvad er Fiasp, og hvad anvendes det til?
English: Insulin aspart enters the bloodstream faster than human insulin after injection and therefore works more quickly.
Danish: Insulin aspart kommer ved injektion hurtigere ind i blodbanen end humant insulin og virker derfor hurtigere.
English: Why is Fiasp authorised in the EU?
Danish: Hvorfor er Fiasp godkendt i EU?
English: The benefits of Fiasp in reducing blood glucose as part of diabetes treatment have been shown in 4 main studies.
Danish: Fiasps evne til at reducere blodsukkeret som led i diabetesbehandling er påvist i fire hovedstudier.
English: In this study, Fiasp was at least as effective as the comparator: there was almost no change in HbA1c in patients given Fiasp at mealtime (0.05 percentage points) and a similar slight increase in those given Fiasp after a meal or NovoRapid at mealtime (0.35 and 0.23 percentage points respectively).
Danish: I dette studie var Fiasp mindst lige så effektivt som sammenligningspræparatet: Der var næsten ingen ændringer i HbA1c hos patienter, som fik Fiasp ved et måltid (0,05 procentpoint), og der sås en tilsvarende let stigning hos dem, der fik Fiasp efter et måltid eller NovoRapid ved et måltid (henholdsvis 0,35 og 0,23 procentpoint).
English: What are the risks associated with Fiasp?
Danish: Hvilke risici er der forbundet med Fiasp?
English: The main measure of effectiveness was the medicine's ability to decrease the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled over time.
Danish: Virkningen blev hovedsageligt bedømt på lægemidlets evne til at sænke blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodsukkeret er reguleret over tid.
English: Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier in adults given Fiasp, although the total extent of the lowering effect is similar.
Danish: I forhold til det allerede godkendte insulin aspart-middel, NovoRapid, indtræder den blodsukkersænkende virkning tidligere hos voksne, som får Fiasp, men den samlede virkning er den samme.
English: Hypoglycaemia can occur more quickly with Fiasp than with other mealtime insulins.
Danish: Hypoglykæmi kan forekomme hurtigere med Fiasp end med andre måltidsinsuliner.
English: In patients given Fiasp the HbA1c fell after 18 weeks by 1.16 percentage points, compared with 0.22 points in those on long-acting insulin and metformin alone.
Danish: Hos patienter, der fik Fiasp, var HbA1c efter 18 uger faldet med 1,16 procentpoint sammenholdt med 0,22 procentpoint hos dem, der kun fik et langtidsvirkende insulin og metformin.
English: For the full list of side effects and restrictions of Fiasp, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Fiasp fremgår af indlægssedlen.
English: The replacement insulin in Fiasp acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet i Fiasp virker på samme måde som naturligt dannet insulin og hjælper blodsukkeret (glukosen) med at komme ind i cellerne.
English: Fiasp is a solution for injection available in vials, cartridges or pre-filled pens and can only be obtained with a prescription.
Danish: Fiasp er en injektionsvæske, der fås i hætteglas, cylinderampuller eller fyldte injektionspenne, og den fås kun på recept.
English: How is Fiasp used?
Danish: Hvordan anvendes Fiasp?
English: A fourth study in 777 adolescents and children from 2 years of age with type 1 diabetes and a starting HbA1c of around 7.6% compared Fiasp (given at mealtime or 20 minutes after the start of the meal) with NovoRapid (given at mealtime).
Danish: Et fjerde studie hos 777 unge og børn fra to år og opad med type 1-diabetes og en HbA1c-startværdi på ca. 7,6 % sammenlignede Fiasp (givet 20 minutter inde i måltidet) med NovoRapid (givet ved et måltid).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fiasp have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fiasp.
English: How does Fiasp work?
Danish: Hvordan virker Fiasp?
English: One study involving 1,143 adults with type 1 diabetes whose starting HbA1c was around 7.6% found that after 6 months of treatment HbA1c fell by 0.32 percentage points with a mealtime dose of Fiasp, compared with 0.17 points with the other insulin.
Danish: Det ene studie omfattede 1.143 voksne med type 1diabetes, hvis HbA1c var ca. 7,6 %, og viste, at HbA1c efter 6 måneders behandling faldt med 0,32 procentpoint ved administration af en dosis Fiasp til et måltid sammenholdt med 0,17 procentpoint med det andet insulin.
English: What benefits of Fiasp have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Fiasp?
English: A third study involving 236 adults with type 2 diabetes and a starting HbA1c of around 7.9% found that adding mealtime Fiasp to treatment with a long-acting insulin and the diabetes medicine metformin improved blood glucose control.
Danish: Et tredje studie hos 236 voksne med type 2-diabetes og en HbA1c-startværdi på ca. 7,9 % viste, at en dosis Fiasp ved et måltid i tillæg til et langtidsvirkende insulin og diabetesmidlet metformin forbedrede reguleringen af blodsukkeret.
English: In the second study involving 689 adults with type 2 diabetes, the fall after 6 months of treatment (from a starting value of 7.96% and 7.89% respectively) was 1.38 points with Fiasp and 1.36 points with the comparator.
Danish: I det andet studie deltog 689 voksne med type 2-diabetes, og efter 6 måneders behandling udgjorde faldet 1,38 procentpoint med Fiasp og 1,36 procentpoint med referencelægemidlet (efter en startværdi på henholdsvis 7,96 % og 7,89 %).
English: Fiasp can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be injected into a vein but only by a doctor or a nurse.
Danish: Det kan alternativt injiceres i en blodåre, dog kun af en læge eller sygeplejerske.
English: A clinically relevant benefit in lowering blood glucose has been shown in studies with Fiasp.
Danish: Det er i studier af Fiasp påvist, at lægemidlet har en klinisk relevant evne til at sænke blodsukkeret.
English: • if you are more than 3 months pregnant.
Danish: • hvis du er mere end 3 måneder henne i graviditeten.
English: Some people feel dizzy or tired when taking Pritor.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Pritor.
English: One blister contains 7 or 10 tablets.
Danish: En blister indeholder 7 eller 10 tabletter.
English: Aluminium/aluminium blisters (PA/PA/Al/PVC/Al).
Danish: Aluminium/aluminium blister (PA/Al/PVC/Al eller PA/PA/Al/PVC/Al).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 December 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11. december 1998 Dato for seneste fornyelse: 11. december 2008
English: • if you are taking digoxin.
Danish: • hvis du tager digoxin.
English: : for further descriptions, please see sub-section “Description of selected adverse reactions” Description of selected adverse reactions
Danish: : For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger” Beskrivelse af udvalgte bivirkninger
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for glemte, individuelle doser.
English: Do not take Pritor
Danish: Tag ikke Pritor
English: Some side effects can be serious and need immediate medical attention You should see your doctor immediately if you experience any of the following symptoms:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægehjælp Du skal straks kontakte din læge, hvis du får nogle af følgende symptomer:
English: Non-steroidal anti-inflammatory medicinal products
Danish: Non steroide antiinflammatoriske lægemidler
English: (It is also better to avoid Pritor in early pregnancy see pregnancy section.)
Danish: (Du skal desuden helst undgå at bruge Pritor tidligt i graviditeten - se afsnittet om Graviditet)
English: Pritor contains sorbitol.
Danish: Pritor indeholder sorbitol.
English: Volume and/or sodium depletion should be corrected prior to administration of Pritor.
Danish: Volumen- og/eller natriumdepletering bør korrigeres før behandling med Pritor.
English: See also information under the heading “Do not take Pritor”.
Danish: Se også information under overskriften ”Tag ikke Pritor”.
English: Read the package leaflet for further information.
Danish: Læs indlægssedlen for flere oplysninger.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Danish: Den totale plasmaclearance, (Cltot), er høj (ca. 1.000 ml/min) sammenlignet med den hepatiske blodgennemstrømning (ca. 1.500 ml/min).
English: The recommended dose is one tablet a day.
Danish: Den anbefalede dosis er 1 tablet daglig.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaprotein (>99,5%), hovedsagelig til albumin og Alfa I-syreglycoprotein.
English: The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Danish: Telmisartans farmakokinetikske egenskaber er ikke anderledes hos ældre patienter i forhold til de der er under 65 år.
English: After oral (and intravenous) administration telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Danish: Efter oral (og intravenøs) administration blev telmisartan udskilt næsten udelukkende i fæces og hovedsagelig som uforandret stof.
English: You can take Pritor with or without food.
Danish: Pritor kan både tages med mad og uden.
English: Talk to your doctor before taking Pritor:
Danish: Kontakt lægen, før du tager Pritor:
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Der var ingen tegn på mutagenicitet eller relevant klasteogen aktivitet ved in vitro-forsøg og ingen tegn på karcinogenicitet i rotter og mus.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Danish: I farmakokinetiske studier med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100 %.
English: It is important that you take Pritor every day until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage Pritor hver dag, så længe lægen ikke har givet dig besked på andet.
English: Corticosteroïds (systemic route)
Danish: Kortikosteroider (systemisk administration)
English: No dose adjustment is necessary for elderly patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: If you forget to take Pritor
Danish: Hvis du har glemt at tage Pritor
English: Talk to your doctor before taking Pritor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager Pritor, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: Remove your Pritor tablet from the blister only directly prior to intake.
Danish: Tag først din Pritor-tablet ud af blisteren lige før indtagelse.
English: For more detailed information see above under the heading “Cardiovascular prevention”.
Danish: Find mere information i afsnittet ”Kardiovaskulær forebyggelse”.
English: Your doctor may need to change the dose of these other medications or take other precautions.
Danish: Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdsregler.
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Danish: Efter administration af den første dosis telmisartan indtræder den antihypertensive effekt gradvist indenfor 3 timer.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelige, ATC-kode: C09CA07.
English: There are no adequate data from the use of Pritor in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af telmisartan til gravide kvinder.
English: Adverse reactions have been ranked under headings of frequency using the following convention: 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).
Danish: 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).
English: Insomnia, depression, Anxiety
Danish: Søvnløshed, depression
English: If you have the impression that the effect of Pritor is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror, at virkningen af Pritor er for stærk eller svag, så sig det til lægen eller på apoteket.
English: Such conditions should be corrected before the administration of Pritor.
Danish: Sådanne tilstande bør korrigeres før behandling med Pritor.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Danish: I et studie medførte samtidig administration af telmisartan og ramipril en op til 2.5 gange øgning af AUC0-24 og Cmax af ramipril og ramiprilat.
English: Your doctor will normally advise you to stop taking Pritor before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Pritor.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Pritor, før du bliver gravid eller så snart du ved, du er gravid.
English: Tablets should be taken out of the blister shortly before administration.
Danish: Tabletterne skal tages ud af blisteren kort før administration.
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Danish: Telmisartan metaboliseres ved konjugation til glucuronidet til parent compound.
English: Pritor is used to treat essential hypertension (high blood pressure) in adults.
Danish: Pritor bruges til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Danish: Når telmisartan tages med føde, sker der en reduktion i arealet under plasmakoncentrationskurven (AUC0-) på ca. 6% (40 mg dosis) til ca. 19% (160 mg dosis).
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke “angiotensin-convertingenzyme” (kininase-II enzymet), som også nedbryder bradykinin.
English: Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Telmisartan skal opbevares i den forseglede blister på grund af tabletternes hygroskopiske egenskaber.
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Pritor (angivet i punkt 6).
English: Pritor may be less effective in lowering the blood pressure in black patients.
Danish: Pritor kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: When Pritor is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Pritor anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniveauerne for kalium og kreatinin.
English: • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: • hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren.
English: Pritor blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Pritor blokerer angiotensin II´s virkning, så blodkarrene afslappes og blodtrykket falder.
English: • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Danish: • Aldosteronisme (vand eller saltophobning i kroppen samtidig med ubalance i mineral sammensætningen)
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
Danish: • Andet og tredje trimester af graviditeten (se pkt.
English: 2, orthostatic hypotension
Danish: Hypotension 2, ortostatisk hypotension
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i originalpakning for at beskytte mod fugt.
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Danish: Hypoglykæmi (hos diabetespatienter)
English: Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Danish: Passende monitorering af blodglucose bør overvejes, og dosisjustering af insulin eller antidiabetika kan være nødvendig, når det er indiceret.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Danish: Hvis forhøjet blodtryk ikke behandles, kan der ske skader på blodkarrene i flere organer, som kan føre til hjerteanfald, hjerte- eller nyresvigt, slagtilfælde eller blindhed.
English: The safety and efficacy of Pritor in children and adolescents aged below 18 years have not been established.
Danish: Pritors sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Take it as soon as you remember then carry on as before.
Danish: Tag tabletten straks du kommer i tanke om det og fortsæt derefter som normalt.
English: The active substance is telmisartan.
Danish: Aktivt stof: telmisartan.
English: If you are intolerant to some sugars, consult your doctor before taking Pritor.
Danish: Hvis du ikke tåler visse sukkerarter, bør du kontakte lægen, før du tager Pritor.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Pritor.
Danish: Hvis du har nogen af ovenstående tilstande, så fortæl det til lægen eller på apoteket før du tager Pritor.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Possible side effects of Pritor
Danish: Bivirkninger ved Pritor
English: Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Danish: Kaiser-Wilhelm-Allee 51368 Leverkusen Tyskland
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre pakning
English: What you need to know before you take Pritor
Danish: Det skal du vide, før du begynder at tage Pritor
English: Concomitant use requiring caution.
Danish: Nedenstående kombinationer kræver forsigtighed.
English: Pritor is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Din læge vil vælge en anden behandling til dig, hvis du ønsker at amme, specielt hvis dit barn er nyfødt eller er født for tidlig.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på de fremstiller, der er ansvarlige for batchfrigivelse
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Pritor.
Danish: Når der føres motorkøretøj eller betjenes maskiner bør man være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Pritor, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: There is no experience regarding the administration of Pritor in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Pritor til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Danish: Forekomsten af tør hoste var signifikant lavere hos de patienter, der blev behandlet med telmisartan end hos dem, der blev behandlet med ACE-hæmmere i kliniske studier, som direkte sammenlignede disse to antihypertensive behandlinger.
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Danish: Telmisartan er en oralt administreret aktiv specifik angiotensin II-receptorsubtype 1 (AT1)-antagonist.
English: The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively.
Danish: De justerede DBP-ændringer fra baseline var henholdsvis -8,4 (1,5) mmHg; -4,5 (1,6) mmHg og -3,5 (2,1) mmHg.