FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Uncommon
Danish: Ikke almindelig Sjælden
English: Atrial fibrillation Supraventricular tachycardia Arrhythmia Hypertension Syncope
Danish: Ventrikulær takykardi Kongestiv hjertesvigt Atrieflimmer Supraventikulær takykardi Arytmi
English: Xagrid contains lactose.
Danish: Xagrid indeholder lactose.
English: Xagrid contains lactose
Danish: Xagrid indeholder lactose
English: Pulmonary hypertension Pneumonia Pleural effusion Dyspnoea Epistaxis
Danish: Pulmonal hypertension Pneumoni Pleura-effusion Dyspnø
English: • If you have further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: Gastrointestinal disorder
Danish: Obstipation Gastrointestinal e gener
English: What Xagrid is and what it is used for What you need to know before you take Xagrid How to take Xagrid
Danish: Det skal De vide, før De begynder at tage Xagrid Sådan skal De tage Xagrid Bivirkninger
English: Nausea Flatulence
Danish: Nyresvigt Nykturi
English: If you take more Xagrid than you should
Danish: Hvis De har taget for meget Xagrid
English: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Pruritus
Danish: Astæni
English: Therefore platelets should be monitored frequently.
Danish: Antallet vil muligvis stige til værdier over baseline, hvorfor blodplader bør overvåges hyppigt.
English: Colitis Gastritis Gingival bleeding
Danish: Colitis Gastritis Gingivalblødning
English: The active substance is anagrelide.
Danish: Aktivt stof: Anagrelid.
English: Anaemia Pancytopenia Thrombocytopenia Haemorrhage
Danish: Væskeretention Ødemer Vægttab
English: Chest pain Fever Chills Malaise Weakness
Danish: Kuldegysninger Utilpashed Svaghed
English: Excipient(s) with known effect
Danish: AUC (ved NOEL-dosis
English: Infections are more likely.
Danish: Infektioner er mere sandsynlige.
English: Diameter: about 8 mm.
Danish: Diameter: cirka 8 mm.
English: The mechanism of this syndrome is not understood.
Danish: Mekanismen i dette syndrom kendes ikke.
English: Your doctor will take further measures.
Danish: Lægen vil sørge for yderligere foranstaltninger.
English: Take your next dose at the usual time.
Danish: Tag den næste dosis til sædvanlig tid.
English: (Invented) Name Strength
Danish: (Påfundet) navn Styrke
English: Its duration of action is 24 hours - also depending on dose.
Danish: Virkningens varighed er 24 timer - også afhængigt af dosen.
English: System Organ Class
Danish: System Organ Klasse
English: These effects are usually reversible.
Danish: Disse virkninger er i reglen reversible.
English: The overall design of the study was adequately pre-specified in the protocol and was considered acceptable.
Danish: Undersøgelsens generelle opbygning var tilstrækkeligt forud specificeret i protokollen og blev betragtet som acceptabel.
English: Tell your doctor if these effects cause you any problems or if they last for more than one week.
Danish: Fortæl din læge, hvis disse virkninger giver dig problemer, eller hvis de varer i mere end en uge.
English: 1103 Budapest, Gyömrői út 19-21.
Danish: 1103 Budapest Gyömrői út 19-21 Ungarn.
English: Caution is required with concomitant use.
Danish: Forsigtighed er påkrævet ved samtidig brug.
English: Contact your doctor immediately or go to the casualty department of the nearest hospital.
Danish: Kontakt omgående din læge eller skadestuen på det nærmeste hospital.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FREMLAGT AF EMEA
English: - bioequivalence with the monocomponent products has been adequately demonstrated.
Danish: - Bioækvivalens med monokomponentprodukter er blevet tilstrækkeligt dokumenteret.
English: If hypotension occurs, probably as a consequence of this mechanism, it can be corrected by volume expansion
Danish: Hvis der forekommer hypotension, sandsynligvis som en følge af denne mekanisme, kan den korrigeres ved volumenekspansion
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret denne medicin til dig personligt.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE MED NAVNE, LÆGEMIDDELFORM, STYRKEN PÅ LÆGEMIDDELPRODUKTET, ADMINISTRATIONSVEJ, ANSØGERE / INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE
English: With regards to safety, there were 3 drop-out subjects.
Danish: Med hensyn til sikkerhed var der 3 frafaldne undersøgelsespersoner.
English: Dose reduction and/or discontinuation of the diuretic may also be required.
Danish: Dosisreduktion og/eller seponering af diuretikummet kan også være påkrævet.
English: • Heart failure after acute myocardial infarction (during the first 28 days).
Danish: • Hjertestop efter akut myokardieinfarkt (i de første 28 dage).
English: The recommended dose is one tablet daily.
Danish: Den anbefalede dosis er en tablet daglig.
English: Alcohol enhances the hypotensive effect.
Danish: Alkohol øger den hypotensive effekt.
English: Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Danish: Nogle af disse patienter udviklede alvorlige infektioner, der i nogle få tilfælde ikke responderede på intensiv antibiotikabehandling.
English: Lisonorm may influence the ability to drive and operate machines (particularly during the initial period of treatment).
Danish: Lisonorm kan påvirke evnen til at føre motorkøretøj og betjene maskiner (specielt i den indledende periode af behandlingen).
English: The magnitude of antihypertensive effect should be closely monitored after administering the initial dose.
Danish: Størrelsen af den antihypertensive effekt skal nøje monitoreres efter administration af den første dosis.
English: The applicant, Gideon Richter, sought a Marketing Authorisation in several member states (CZ, EE, LT, LV, PL, RO, and SK,) through the Mutual Recognition Procedure with Hungary acting as the reference member state.
Danish: Ansøgeren, Gideon Richter, søgte om markedsføringstilladelse i flere medlemsstater (CZ, EE, LT, LV, PL, RO og SK) via den gensidige godkendelsesprocedure med Ungarn, der fungerede som referencemedlemsstat.
English: A total of 96 post-dose adverse events were reported by 35 of the 48 subjects who received at least one dose of the study medication.
Danish: Der blev indberettet i alt 96 postdosis bivirkninger af 35 af de 48 undersøgelsespersoner, der fik mindst en dosis af undersøgelseslægemidlet.
English: Additionally, there was a high incidence of QT prolongation observed in 16.7% subjects (n=8).
Danish: Derudover var der en høj forekomst af forlænget QT-interval, som observeredes hos 16,7 % af undersøgelsespersonerne (n=8).
English: The use of ACE inhibitors is not recommended during the first trimester of pregnancy and they are contraindicated in the second and third trimester.
Danish: Anvendelse af ACE-hæmmere kan ikke anbefales i første trimester af graviditeten, og de er kontraindicerede i andet og tredje trimester.
English: • insulin and oral antidiabetics
Danish: • insulin og orale antidiabetika
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Danish: Dette fænomen lod til at forekomme hyppigere under de første uger af en kombineret behandling og hos patienter med nedsat nyrefunktion.
English: In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
Danish: Hos patienter med normal nyrefunktion og uden andre komplicerende faktorer, forekommer der sjældent neutropeni.
English: No experience is available with the use of Lisonorm in pregnant women from adequately controlled clinical studies.
Danish: Der er ingen tilgængelige erfaringer med brugen af Lisonorm til gravide kvinder fra tilstrækkeligt kontrollerede kliniske undersøgelser.
English: The effective half-life of lisinopril is 12.6 hours.
Danish: Den effektive halveringstid for lisinopril er 12,6 timer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LISONORM AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LISONORM OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Since amlodipine is slowly absorbed, gastric lavage can be useful in some cases.
Danish: Da amlodipin absorberes langsomt, kan gastrisk lavage være nyttigt i visse tilfælde.
English: The sampling interval and wash-out period were considered long enough and the statistical evaluation was also appropriate.
Danish: Prøveinterval og udvaskningsperiode blev betragtet som tilstrækkeligt lange, og også den statistiske evaluering var relevant.
English: - severe itching of the skin (with raised lumps).
Danish: - alvorlig hudkløe (med hævede områder).
English: • Unstable angina pectoris (excluding Prinzmetal's angina).
Danish: • Ustabil angina pectoris (med undtagelse af Prinzmetals angina).
English: Always take Lisonorm exactly as your doctor has told you.
Danish: Tag altid Lisonorm nøjagtigt efter lægens anvisning.
English: Therefore, concomitant administration should be carefully considered and only undertaken with increased caution and regular monitoring of both serum potassium levels and renal function.
Danish: Derfor bør samtidig administration nøje overvejes og kun foretages med øget forsigtighed og jævnlig monitorering af både serumkaliumniveauerne og nyrefunktionen.
English: • anticancer drugs
Danish: • medicin mod kræft
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Folded Carton
Danish: OPLYSNINGER, DER SKAL STÅ PÅ DEN YDRE EMBALLAGE Foldet æske
English: Elimination from the plasma is biphasic with a terminal elimination half-life of about 30-50 hours.
Danish: Udskillelse fra plasma er bifasisk med en endelig udskillelses-halveringstid på cirka 30-50 timer.
English: Like all medicines, Lisonorm can cause side effects, although not everybody gets them.
Danish: Lisonorm kan, som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The appearance of QT prolongation was similar in all 3 different treatment options, and there were no statistically significant differences between predose and post-dose QTc values.
Danish: Forekomsten af forlængelse af QTinterval var tilsvarende ved alle 3 forskellige behandlingsmuligheder, og der var ingen statistisk signifikante forskelle mellem prædosis og postdosis QTc-værdier.
English: Store in the original package in order to protect from light and moisture.
Danish: Opbevares i den originale pakning for at beskytte produktet mod lys og fugt.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: Pharmacokinetic parameters (AUC, Cmax, tmax, half-life) were not different from those observed after administration of the individual components separately.
Danish: Farmakokinetiske parametre (AUC, Cmax, tmax, halveringstid) adskilte sig ikke fra dem, der observeredes efter administration af de enkelte bestanddele separat.
English: Taking Lisonorm with food and drink Lisonorm can be taken with or without food, but alcohol should be avoided during treatment.
Danish: Lisonorms interaktioner med mad og drikkevarer Lisonorm kan indtages med eller uden mad, men du bør undgå alkohol under behandlingen.
English: If you have the impression that the effect of Lisonorm is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener, at virkningerne af Lisonorm er for kraftige eller for svage, bør du tale med lægen eller apoteket om det.
English: Its absorption is unaffected by the consumption of food.
Danish: Dets absorption påvirkes ikke ved indtagelse af føde.
English: Frequencies are defined as follows: 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 som: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Usædvanlig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000), Ikke kendt (kan ikke bestemmes ud fra tilgængelige data).
English: The maximum daily dose is one tablet.
Danish: Den maksimale dosis er en tablet daglig.
English: Allergic (hypersensitivity) reactions may occur with the use of Lisonorm .
Danish: Allergiske (overfølsomheds-) reaktioner kan forekomme ved brug af Lisonorm.
English: Accordingly, amlodipine is contraindicated during pregnancy.
Danish: Følgelig er amlodipin kontraindiceret under graviditet.
English: The antihypertensive efficacy of lisinopril is also maintained on the long term.
Danish: Den antihypertensive effekt af lisinopril bevares også på langt sigt.
English: In these patients, it is recommended to use a different type of dialysis membrane or a different class of antihypertensive agent.
Danish: Hos disse patienter anbefales det at benytte en anden type dialysemembran eller en anden klasse af antihypertensionsmiddel.
English: Frequencies are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Danish: Meget almindelig: Påvirker mere end 1 ud af 10 brugere Almindelig: Påvirker 1 til 10 ud af 100 brugere Ikke almindelig: Påvirker 1 til 10 ud af 1.000 brugere Sjælden: Påvirker 1 til 10 ud af 10.000 brugere Meget sjælden: Påvirker mindre end 1 ud af 10.000 brugere Ikke kendt: Hyppigheden kan ikke vurderes ud fra de tilgængelige data.
English: Due to the slow onset of action, acute hypotension does not occur.
Danish: På grund af den langsomt indsættende virkning forekommer der ingen akut hypotension
English: Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated and therefore, normal dose is recommended for older people.
Danish: Amlodipine anvendt ved lignende doser hos ældre eller yngre patienter tåles lige godt, og derfor anbefales normal dosis til ældre personer.
English: In such cases, Lisonorm should be discontinued immediately and the patient kept under close medical supervision until complete and sustained resolution of symptoms has occurred.
Danish: I sådanne tilfælde bør Lisonorm omgående seponeres, og patienten holdes under nøje lægelig observation, indtil symptomerne er helt og vedvarende ophørt.
English: If available, treatment with angiotensin II infusion may also be considered.
Danish: Hvis behandling med angiotensin II-infusion er tilgængelig, kan det også tages i betragtning.
English: Concomitant use with glyceryl trinitrate and other nitrates, or other vasodilators, may further reduce blood pressure.
Danish: Anvendelse samtidigt med glyceryltrinitrat og andre nitrater eller andre vasodilatorer kan yderligere reducere blodtrykket.
English: It reduces peripheral vascular resistance and systemic blood pressure.
Danish: Det reducerer den perifere vaskulære resistens og det systemiske blodtryk.
English: Subjects were selected by appropriate inclusion criteria and the regimen was standardized, excluding factors influencing pharmacokinetic interactions.
Danish: Undersøgelsespersonerne blev udvalgt efter relevante inklusionskriterier, og regimet var standardiseret og udelukkede faktorer, der kunne påvirke farmakokinetiske interaktioner.
English: SPECIAL STORAGE CONDITIONS Store below 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Skal opbevares ved temperaturer under 25 °C.
English: In the systemic circulation 95 to 98 % of amlodipine is bound to plasma protein.
Danish: I det systemiske kredsløb er 95 til 98 % af amlodipinet bundet til plasmaprotein.
English: When pregnancy is diagnosed, treatment with Lisonorm should be stopped immediately.
Danish: Hvis der konstateres graviditet, skal behandling med Lisonorm omgående seponeres.
English: Amlodipine clearance tends to be lower with resulting increase in AUC and elimination half-life in the elderly.
Danish: Amlodipin-clearance har tendens til at være lavere med påfølgende forhøjelse i AUC og udskillelseshalveringstid hos ældre.
English: Children and adolescents Lisonorm is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Danish: Lisonorm bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og effekt.
English: • Severe hypotension.
Danish: • Alvorlig hypotension.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel fare for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagne doser, genotoksicitet og karcinogent potentiale.
English: Pemphigus, Diaphoresis.
Danish: Pemphigus, diaforese.
English: There is, however, no clinical experience with the use of amlodipine in pregnancy.
Danish: Der findes dog ingen klinisk erfaring med brugen af amlodipin under graviditet.
English: Overdose is likely to result in very low blood pressure, which has to be closely monitored, and if characteristic symptoms such as dizziness and headache occur, you should be placed lying down with the face up.
Danish: Overdosering vil sandsynligvis medføre meget lavt blodtryk, der skal overvåges nøje, og hvis der opstår karakteristiske symptomer som svimmelhed og hovedpine, bør du lægge dig ned med ansigtet opad.
English: Preferably, sodium and/or volume depletion should be corrected before treatment with Lisonorm is started.
Danish: Natrium- og/eller volumenmangel skal helst korrigeres, før behandling med Lisonorm påbegyndes.
English: Overall, the CHMP considered that the applicant had responded adequately by providing the results of an additional study, BES No.67289, and had demonstrated formal proof of bioequivalence.
Danish: Alt i alt anså CHMP, at ansøgeren havde fremlagt tilstrækkeligt svar ved at dokumentere resultaterne af en yderligere undersøgelse, BES Nr.67289, og havde fremlagt formel dokumentation for bioækvivalens.
English: Intravenous administration of calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Danish: Intravenøs administration af calciumgluconat kan være gavnlig og ophæve virkningerne af calciumkanalblokade.
English: You might not have any symptoms from your too high blood pressure, but it may increase the risk of certain complications (such as stroke or heart attack), if you do not take your antihypertensive medicine regularly.
Danish: Det er ikke sikkert, du har symptomer på dit forhøjede blodtryk, men det kan øge risikoen for visse komplikationer (såsom hjerneblødning eller hjerteanfald), hvis du ikke tager din blodtryksmedicin regelmæssigt.
English: • narcotics, morphine and related drugs used to treat severe pain
Danish: • narkotika, morfin og lignende former for medicin til behandling af svære smerter
English: The antihypertensive effect of lisinopril usually ensues 1 hour after administration and peaks after 6 hours.
Danish: Den antihypertensive effekt af lisinopril følger i reglen 1 time efter administrationen og kulminerer efter 6 timer.
English: These changes may be accompanied by an increase in cardiac output at unchanged heart frequency, as well as an increase in renal blood flow.
Danish: Disse ændringer kan være ledsaget af en forøgelse af den kardielle effekt med uændret hjertefrekvens samt en forøgelse af blodgennemstrømningen i nyrerne.
English: No precise dosage recommendations have been established for such cases and, therefore, this medicinal product should be administered with caution to patients with hepatic impairment.
Danish: Der er ikke fastsat nogen præcise doseringsanbefalinger for sådanne tilfælde, og derfor bør dette lægemiddel administreres med forsigtighed til patienter med leverinsufficiens.
English: No pharmacokinetic interactions have been described between the active substances of Lisonorm .
Danish: Der er ikke beskrevet nogen farmakokinetiske interaktioner mellem de aktive stoffer i Lisonorm.
English: Once daily dosing of amlodipine reduces the blood pressure of hypertensive patients both in the supine and standing position throughout the 24-hour interval.
Danish: Dosering af amlodipin en gang dagligt reducerer blodtrykket hos hypertensive patienter, både i liggende og stående stilling over hele 24-timers intervallet.
English: • other medicines used to lower blood pressure (antihypertensives)
Danish: • anden medicin, der bruges til sænkning af blodtrykket (antihypertensiva)
English: Since no dose recommendations have been established, this medicinal product should therefore be administered with caution, weighing individually the expected benefits and potential risks of the treatment.
Danish: Da der ikke er fastlagt nogen dosisanbefalinger, bør dette lægemiddel derfor administreres med forsigtighed, idet de forventede fordele vejes op mod de potentielle risici ved behandlingen.
English: The most common adverse reactions with the combination were headache (8%), cough (5%), and dizziness (3%).
Danish: De mest almindelige bivirkninger ved kombinationen var hovedpine (8 %), hoste (5 %) og svimmelhed (3 %).
English: LC-MS/MS methods were validated for analysis of both compounds, and the stability of the samples was documented over the period of sample storage.
Danish: LC-MS/MS-metoder blev valideret for analyse af begge præparater, og prøvestabiliteten blev dokumenteret over prøveopbevaringsperioden.
English: If Lisonorm is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Danish: Hvis Lisonorm benyttes til sådanne patienter, tilrådes periodisk monitorering af leykocyttal, og patienterne bør instrueres om at rapportere eventuelle tegn på infektion.
English: If concomitant use of the abovementioned substances is needed, regular monitoring of potassium serum levels is recommended (see section 4.5).
Danish: Hvis der er behov for samtidig anvendelse af ovennævnte stoffer, anbefales regelmæssig monitorering af kaliumserumniveauerne (se punkt 4.5).
English: Do not take a double dose to make up for a forgotten tablet, to avoid the risk of overdose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: • Hypersensitivity to amlodipine or to any other dihydropyridine derivatives.
Danish: • Overfølsomhed over for amlodipin eller andre dihydropyridin-derivater.
English: Abrupt discontinuation of lisinopril treatment is not associated with any substantial rebound effect (blood pressure elevation).
Danish: Pludselig seponering af lisinopril-behandling er ikke forbundet med nogen substantiel rebound-effekt (blodtryksforhøjelse).
English: Amlodipine, however, is highly protein-bound and, therefore, dialysis is not likely to be of benefit (see section 4.4.)
Danish: Amlodipin er derimod stærkt proteinbundet, og det er derfor ikke sandsynligt, at dialyse vil være gavnligt (se punkt 4.4.)
English: This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State} {Name of the medicinal product} [See Annex I - To be completed nationally]
Danish: Dette lægemiddelprodukt er godkendt i medlemslandene af EØF under følgende navne: {Navnet på medlemsstaten} {Navnet på lægemidlet} [Se Bilag I - Skal udfærdiges nationalt]
English: Steady-state plasma levels are reached after 7 to 8 days of consecutive daily dosing.
Danish: Stationære plasmaniveauer nås efter 7 til 8 dages konsekutiv daglig dosering.
English: Driving and using machines Lisonorm can affect your ability to drive and use machinery safely.
Danish: Trafik- og arbejdssikkerhed Lisonorm kan påvirke din evne til at køre bil og betjene maskiner sikkert.
English: Micturition disorder, Nocturia, Increased urinary frequency
Danish: Miktionsforstyrrelse, nocturi, øget vandladningsfrekvens