FrancophonIA/ELRC3.0 huggingface dataset:
English: Peak plasma concentration (Cmax) occurs 6 to 10 hours after dosing.
Danish: Maksimal plasmakoncentration (Cmax) sker 6 til 10 timer efter dosering.
English: Patients planning pregnancy Lisonorm should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Hos patienter, der planlægger graviditet, skal Lisonorm udskiftes med en alternativ anti-hypertensiv behandling, der har en påvist sikkerhedsprofil til brug under graviditet.
English: Special caution is necessary when Lisonorm is taken together with the following medicines:
Danish: Det er nødvendigt at være særlig forsigtig, når Lisonorm tages sammen med følgende præparater:
English: As expected in this type of medicinal product, headache was the most commonly reported adverse event.
Danish: Som forventet ved denne type lægemiddel var hovedpine den almindeligst rapporterede bivirkning.
English: • Pregnancy and lactation (see section 4.6).
Danish: • Graviditet og amning (se punkt 4.6).
English: During a controlled clinical study (n=195), the incidence of adverse reactions was not higher in subjects receiving both active substances concomitantly than in patients on monotherapy.
Danish: Under en kontrolleret klinisk undersøgelse (n=195) var forekomsten af bivirkninger ikke højere hos forsøgspersoner, der fik begge de aktive indholdsstoffer samtidigt, end hos patienter i monoterapi.
English: Do not use Lisonorm tablets after the expiry date which is stated on the blisters and the carton after ‘Exp'.
Danish: Brug ikke Lisonorm-tabletter efter den udløbsdato, der står på blisterpakningerne og på æsken efter "Exp'" Udløbsdatoen er den sidste dag i den nævnte måned.
English: Symptomatic treatment (placing the patient in a supine position, monitoring - and when necessary, support - of cardiac function, blood pressure, fluid and electrolyte balance) is recommended.
Danish: Symptomatisk behandling (anbringelse af patienten i liggende stilling, monitoreringog om nødvendigt støtte - af hjertefunktion, blodtryk, væske- og elektrolytbalance) anbefales.
English: • Haemodynamically significant obstruction in the outflow tract of the left ventricle (aortic stenosis,
Danish: • Hæmodynamisk signifikant obstruktion i udløbskanalen fra venstre ventrikel (aortastenose,
English: • Hereditary or idiopathic angioedema (see section 4.4).
Danish: • Hereditært eller idiopatisk angioødem (se punkt 4.4).
English: For Lisonorm (new lisinopril 10mg/ amlodipine 5mg combination), a positive benefit/risk ratio had not been established given that the initial bioequivalence study submitted was not conducted with the appropriate control, and that preliminary results of a new bioequivalence study (No.67289) did not allow a full assessment of the benefit risk ratio.
Danish: For Lisonorm (ny lisinopril 10 mg/ amlodipin 5 mg-kombination) var der ikke dokumenteret noget positivt benefit/risk-forhold, idet den forelagte indledende bioækvivalensundersøgelse ikke var gennemført med behørig kontrol, og de præliminære resultater af en ny bioækvivalensundersøgelse (nr. 67289) tillod ikke en fuldstændig vurdering af benefit/riskforholdet.
English: This may result in prolonged bleeding, tiredness, weakness, disease of the lymph node, autoimmune disease (in which the body attacks itself).
Danish: Dette kan medføre forlænget blødning, træthed, svaghed, lymfeknudesygdom, autoimmunsygdom (hvor kroppen angriber sig selv).
English: Very rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant necrosis and (sometimes) death.
Danish: ACE-hæmmere er i yderst sjældne tilfælde blevet associeret med et syndrom, der starter med cholestatisk gulsot eller hepatitis og progredierer til fulminant nekrose og (sommetider) død.
English: Angioedema accompanied by laryngeal oedema is potentially fatal.
Danish: Angioødem ledsaget af laryngealt ødem kan være fatalt.
English: An Article 29 referral procedure was initiated due to concerns raised by the CZ and LV on the potential serious risk to public health regarding insufficient proof of bioequivalence since the Applicant did not use the originator´s products (Aulin Gel) as reference treatments but used monocomponent-containing generics in the originally submitted bioequivalence study.
Danish: Der blev indledt en indbringelsesprocedure i henhold til artikel 29 som følge af spørgsmål rejst af CZ og LV vedrørende en potentiel alvorlig risiko for folkesundheden i forbindelse med utilstrækkelig dokumentation for bioækvivalens, idet ansøgeren ikke benyttede de oprindelige produkter (Aulin Gel) som referencebehandlinger, men benyttede monokomponentholdige generika i den oprindeligt indbragte bioækvivalensundersøgelse.
English: Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Danish: Intestinalt angioødem bør medtages i den differentielle diagnosticering af patienter på ACE-hæmmere, der møder med abdominale smerter.
English: Appropriate measures include the subcutaneous administration of 0.3-0.5 mg adrenaline epinephrine or the slow intravenous administration of 0.1 mg adrenaline, followed by glucocorticoids and antihistamines, with simultaneous monitoring of vital functions.
Danish: Passende foranstaltninger omfatter subkutan administration af 0,3-0,5 mg adrenalin, epinephrin eller langsom intravenøs administration af 0,1 mg adrenalin efterfulgt af glucocorticoider og antihistaminer med samtidig monitorering af de vitale funktioner.
English: If the oedematous swelling involves the tongue, glottis or larynx, or it is likely to cause airway obstruction; emergency treatment should be initiated promptly.
Danish: Hvis den ødematøse hævelse omfatter tunge, glottis eller larynx, eller den med sandsynlighed kan forårsage luftvejsobstruktion, skal akut behandling omgående indledes.
English: INFORMATION IN BRAILLE Lisonorm 10/5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Lisonorm 10/5 mg
English: Very rare
Danish: Meget sjældent
English: The major elimination of non protein-bound fraction is accompanied by that of ACE-bound lisinopril at a slower rate, and this can result in prolonged antihypertensive action.
Danish: Den vigtigste elimination af ikke proteinbunden fraktion er ledsaget af eliminationen af ACE-bundet lisinopril i en langsommere hastighed, og dette kan medføre forlænget antihypertensiv aktion.
English: In controlled clinical trials conducted in diabetic patients, no changes of blood glucose level and no increase in the incidence of hypoglycaemia were ascertained.
Danish: Ved kontrollerede kliniske forsøg gennemført med diabetespatienter blev der ikke fundet nogen ændringer af blodglucoseniveau og ingen forøget forekomst af hypoglykæmi.
English: • lithium, antipsychotics, used to treat mental disorders
Danish: • lithium, antipsykotika, bruges til behandling af psykiske lidelser
English: Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for amlodipine provide no evidence for a teratogenic effect (see section 5.3).
Danish: Selv om visse dihydropyridinpræparater er teratogene på dyr, giver data fra rotter og kaniner for amlodipin ingen evidens for en teratogen virkning (se punkt 5.3).
English: In case of serious hypotension, the lower extremities should be elevated, and when intravenous administration of fluid does not elicit sufficient response, supportive treatment added-on with administration of peripheral vasopressor agents may be necessary, unless contraindicated.
Danish: I tilfælde af alvorlig hypotension skal underekstremiteterne eleveres, og hvis intravenøs administration af væske ikke giver tilstrækkelig respons, kan det være nødvendigt med yderligere støttende behandling samtidig med administration af perifere vasopressormidler, medmindre det er kontraindiceret.
English: In line with the regulatory requirements (CHMP/EWP/191583/2005), a formal proof of bioequivalence, evidence of a wide therapeutic experience, and an adequately established benefit/risk ratio should be demonstrated for new fixed dose combination products claiming substitution indication.
Danish: I henhold til myndighedskravene (CHMP/EWP/191583/2005) skal der foreligge en formel dokumentation for bioækvivalens, bevis for en bred terapeutisk erfaring og et tilstrækkeligt dokumenteret benefit/risk-forhold for nye fastdosiskombinationsprodukter, som påberåber sig substitutionsindikation.
English: It is not known whether amlodipine is excreted in human milk.
Danish: Det vides ikke, om amlodipin udskilles i modermælk.
English: Rarely, acute renal failure may occur, especially in patients with compromised renal function such as the elderly or dehydrated.
Danish: I sjældne tilfælde kan der forekomme akut nyresvigt, især hos patienter med nedsat nyrefunktion, såsom ældre eller dehydrerede.
English: Other antihypertensives: Concomitant use of these agents may increase the hypotensive effects of Lisonorm .
Danish: Andre antihypertensiva: Samtidig anvendelse af disse midler kan øge de hypotensive virkninger af Lisonorm.
English: You must stop taking Lisonorm and seek medical attention immediately if you develop any of the following symptoms of angioedema: - difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
Danish: Du skal omgående ophøre at tage Lisonorm og søge læge, hvis du oplever nogle af følgende symptomer på angioødem: - åndedrætsbesvær med eller uden hævelse af ansigt, læber, tunge og/eller svælg.
English: Amlodipine exerts antianginal effect through the dilation of peripheral arterioles as well as through reduction of cardiac afterload, without resulting in reflex tachycardia, and accordingly, energy consumption and oxygen demand of cardiac muscle decrease.
Danish: Amlodipin udøver antianginal virkning ved dilatation af perifere arterioler samt via reduktion af det kardielle afterload uden, at det medfører refleks-takykardi, og følgelig energiforbrug og iltbehov ved kardiel muskelrelaksation.
English: In summary, there were no differences with respect to adverse events associated with the administration of amlodipine and lisinopril between the three investigated treatments, and no additional safety issues were raised by the results of the study.
Danish: Sammenfattet var der ingen forskelle med hensyn til bivirkninger forbundet med administration af amlodipin og lisinopril mellem de tre undersøgte behandlinger, og undersøgelsens resultater gav ikke anledning til nogen yderligere sikkerhedsspørgsmål.
English: Compensatory activation of the renin-angiotensin-aldosterone system (RAAS) should be expected and therefore, counter-regulatory mechanisms activated by ACE inhibitors may contribute to the restoration of physiological responses to increased salt intake.
Danish: Kompensatorisk aktivering af renin-angiotensin-aldosteronsystemet (RAAS) er forventeligt, og derfor kan modregulatoriske mekanismer aktiveret af ACE-hæmmere bidrage til retablering af fysiologiske responser på øget indtagelse af salt.
English: If a medicinal product that affects potassium levels is to be prescribed in combination with lisinopril, monitoring of potassium serum levels is advised.
Danish: Hvis et lægemiddel, der påvirker kaliumniveauerne, skal ordineres i kombination med lisinopril, tilrådes monitorering af kaliumserumniveauerne.
English: Calcium channel blocking activity, for example elicits direct arterial dilation accompanied by sodium and water retention.
Danish: Den calciumkanal-blokerende aktivitet fremkalder for eksempel direkte arteriel dilatation ledsaget af natrium- og vand-retention.
English: 10 mg/5 mg tablets oral use
Danish: 10 mg / 5 mg tabletter oral anvendelse
English: Lisonorm should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.
Danish: Lisonorm bør anvendes med yderste forsigtighed til patienter med kollagen vaskulær sygdom, behandling med immunsuppressiva, behandling med allopurinol eller procainamid eller en kombination af disse komplicerende faktorer, specielt hvis der er præeksisterende nedsat nyrefunktion.
English: The elimination of lisinopril is prolonged in renal impairment and therefore, dose reduction may be necessary (see section 4.2).
Danish: Eliminationen af lisinopril er forlænget ved nedsat nyrefunktion, og derfor kan en dosisreduktion være nødvendig (se punkt 4.2).
English: In patients with renal impairment, changes in amlodipine plasma concentrations are not correlated with degree of renal impairment.
Danish: Hos patienter med nyreinsufficiens er ændringer i amlodipin-plasmakoncentrationer ikke korreleret til graden af nyreinsufficiensen.
English: Lithium: Lithium elimination may be reduced during concomitant use of ACE inhibitor and therefore, serum lithium levels should be monitored.
Danish: Lithium: Lithium-udskillelsen kan være nedsat ved samtidig anvendelse af ACE-hæmmer, og derfor bør serumlithiumniveauerne monitoreres.
English: If hypotension occurs, the patient should be placed in a supine position and intravenous fluid replacement (intravenous infusion of physiologic saline) should be administered if necessary.
Danish: Hvis der forekommer hypotension, skal patienten placeres i liggende stilling, og der indgives om nødvendigt væskeerstatning intravenøst (intravenøs infusion af fysiologisk saltvand).
English: How to store Lisonorm Further information
Danish: Sådan opbevarer du Lisonorm Yderligere oplysninger
English: Symptomatic hypotension
Danish: Symptomatisk hypotension
English: No teratogenic effects of lisinopril were seen in mice, rats and rabbits given doses that were 55 times, 33 times and 0.15 times, respectively, the maximum recommended human daily dose.
Danish: Der sås ingen teratogene virkninger af lisinopril i mus, rotter og kaniner, der fik doser, der var henholdsvis 55 gange, 33 gange og 0,15 gange den maksimalt anbefalede daglige humane dosis.
English: CYP3A4 inhibitors: A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4 (plasma concentration increases by approximately 50% and the effect of amlodipine is increased).
Danish: CYP3A4-hæmmere: En undersøgelse på ældre patienter har vist, at diltiazem hæmmer metaboliseringen af amlodipin, sandsynligvis via CYP3A4 (plasmakoncentrationen øges med cirka 50 %, og effekten af amlodipin øges).
English: Amlodipine is slowly and almost completely absorbed from the gastrointestinal tract following oral administration.
Danish: Amlodipin absorberes langsomt og næsten fuldstændigt fra mave-tarm-kanalen efter oral administration.
English: Diuretics: When a diuretic is added to the therapy of a patient receiving Lisonorm the antihypertensive effect is usually additive (see section 4.4).
Danish: Diuretika: Hvis der tilføjes et diuretikun til behandlingen af en patient, der får Lisonorm, er den antihypertensive effekt i reglen additiv (se punkt 4.4).
English: Pancreatitis, Gastritis, Gingival hyperplasia
Danish: Pankreatitis, gastritis, gingival hyperplasi
English: Non-steroidal anti-inflammatory drugs (NSAIDs): Chronic administration of NSAIDs, including high-dosed acetylsalicylic acid ≥ 3 g/day, may reduce the antihypertensive effect of an ACE inhibitor.
Danish: Non-steroide antiinflammatoriske stoffer (NSAID'er): Kronisk administration af NSAID'er, herunder højdosis acetylsalicylsyre ≥ 3 g/dag, kan reducere den antihypertensive virkning af en ACE-hæmmer.
English: If you forget to take Lisonorm
Danish: Hvis du glemmer at tage Lisonorm
English: Adverse reactions were usually mild, transient and rarely warranted the discontinuation of treatment with Lisonorm .
Danish: Bivirkningerne var i reglen milde, forbigående og berettigede sjældent seponering af behandlingen med Lisonorm.
English: The 90% confidence intervals calculated for AUC(0-t), AUC(0-inf) and Cmax were within the range of 0.8-1.25 for both components (lisinopril and amlodipine).
Danish: De 90 % konfidensintervaller beregnet for AUC(0-t), AUC(0-inf) og Cmax lå inden for området 0,8-1,25 for begge komponenter (lisinopril og amlodipin).
English: Lisonorm is used to treat hypertension (high blood pressure).
Danish: Lisonorm bruges til behandling af forhøjet blodtryk (hypertension).
English: Although its primary effect is mediated by the renin-angiotensin-aldosterone system, lisinopril is also effective in hypertensive patients with low plasma renin activity.
Danish: Selv om dets primære effekt formidles via renin-angiotensin-aldosteronsystemet, er lisinopril også effektivt hos hypertensive patienter med lav plasma-renin aktivitet.
English: Lisinopril mitigates the kaliuretic effect of diuretics.
Danish: Lisinopril dæmper diuretikaenes kaliuretiske effekt.
English: The possibility that more potent inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
Danish: Muligheden for, at mere potente hæmmere af CYP3A4 dvs. ketoconazol, itraconazol, ritonavir) kan øge plasmakoncentrationen af amlodipin i større omfang end diltiazem kan ikke udelukkes.
English: Psoriasis, Urticaria, Alopecia
Danish: Psoriasis, urtikaria, alopeci
English: • medicines used to treat bacterial (rifampicin), HIV (ritonavir) or fungal infections (ketoconazole).
Danish: • medicin til behandling af bakterielle infektioner (rifampicin), HIV-infektioner (ritonavir) eller svampeinfektioner (ketoconazol)
English: Neutropenia and agranulocytosis are reversible after discontinuation of the ACE inhibitor.
Danish: Neutropeni og agranulocytose er reversible efter seponering af ACE-hæmmeren.
English: Aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy As with all vasodilators, Lisonorm should be administered with caution to patients with obstruction in the outflow tract of the left ventricle and with stenosis of mitral valve.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved alle vasodilatorer skal Lisonorm administreres med forsigtighed til patienter med obstruktion i udstrømningskanalen fra venstre ventrikel samt med mitralklapstenose.
English: hypertrophic cardiomyopathy), mitral stenosis or cardiogenic shock.
Danish: hypertrofisk kardiomyopati), mitralstenose eller kardiogent chok.
English: The time to reach peak plasma concentrations (tmax) of amlodipine is similar in elderly and younger subjects.
Danish: Tid til maksimale plasmakoncentrationer (tmax) af amlodipin er tilsvarende hos ældre og yngre forsøgspersoner.
English: Lisonorm is not recommended for breast-feeding mothers, as lisinopril may be excreted in human milk (see section 4.3).
Danish: Lisonorm frarådes til ammende mødre, idet lisinopril kan udskilles i modermælk (se punkt 4.3).
English: Interactions related to amlodipine
Danish: Interaktioner relateret til amlodipin
English: Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy.
Danish: Typisk er hosten ikke-produktiv og ophører efter seponering af behandlingen.
English: White or off-white, round, flat, bevel-edged tablet with a score line on one side and with an engraving „A+L” on the reverse side.
Danish: Hvid eller off-white, rund, flad tablet med affaset kant og delekærv på den ene side med indgraveringen “A+L” på den anden side.
English: Tricyclic antidepressants/antipsychotics/anaesthetics/narcotics: Concomitant use with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Danish: Tricykliske antidepressiva/antipsykotika/anæstetika/narkotika: Anvendelse samtidigt med ACEhæmmere kan medføre yderligere nedsættelse af blodtrykket (se punkt 4.4).
English: Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Erythema multiforme.
Danish: Meget sjældent Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme.
English: Amlodipine reduces the tone of smooth muscle in arterioles and hence the peripheral vascular resistance which lowers systemic blood pressure.
Danish: Amlodipin reducerer tonus i den glatte muskulatur i arterioler og dermed den perifere vaskulære resistens, der sænker det systemiske blodtryk.
English: Amlodipine (n=64)
Danish: Amlodipin (n=64)
English: Lisinopril is an angiotensin converting enzyme (ACE) inhibitor, which results in reduction of plasma angiotensin II and consequently aldosterone levels and elevates those of vasodilatory bradykinin.
Danish: Lisinopril er en angiotensinkonverterende enzymhæmmer (ACE-hæmmer), hvilket medfører en reduktion af angiotensin II i plasma og følgelig også af aldosteron-niveauerne og forhøjer niveauerne af vasodilatorisk bradykinin.
English: The geometric mean ratios, 90% confidence intervals and corresponding intra-individual CVs for Cmax, AUC0-t and AUC0-∞ for amlodipine and lisinopril were also presented.
Danish: Også de geometriske gennemsnitsforhold, 90 % konfidensintervaller og tilsvarende intra-individuelle CV'er for Cmax, AUC0-t og AUC0-∞ for amlodipin og lisinopril blev fremlagt.
English: Since food does not affect absorption, Lisonorm may be taken irrespective of meals.
Danish: Da føde ikke påvirker absorptionen, kan Lisonorm indtages med eller uden mad.
English: Uncommon Myocardial infarction (see section 4.4), Tachycardia, Palpitations,
Danish: Myokardieinfarkt (se punkt 4.4), takykardi, palpitationer,
English: In addition to its direct blood pressure lowering effect, lisinopril mitigates albuminuria by modifying the haemodynamic conditions and tissue structure in the renal glomeruli.
Danish: Ud over den direkte blodtrykssænkende effekt dæmper lisinopril albuminuri ved at modificere de hæmodynamiske betingelser og vævsstrukturen i nyrernes glomeruli.
English: WHAT LISONORM IS AND WHAT IT IS USED FOR
Danish: LISINORMS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: Diameter: about 8 mm The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Danish: Diameter: cirka 8 mm Delekærven er der, for at tabletten kan deles, så den er nemmere at sluge, ikke for at kunne dosere to halve tabletter.
English: - The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A) and magnesium stearate.
Danish: - De øvrige indholdsstoffer er mikrokrystallinsk cellulose, natriumstivesesglycolat (type A) og magnesiumstearat.
English: In clinical studies, there was no age-related change in the efficacy or safety profile of amlodipine or lisinopril.
Danish: Ved kliniske undersøgelser var der ingen aldersrelaterede ændringer i effekt- eller sikkerhedsprofilen for amlodipin eller lisinopril.
English: This is more likely to occur in patients with pre-existing renal impairment.
Danish: Det er mere sandsynligt, at dette vil forekomme hos patienter med eksisterende nyreinsufficiens.
English: Pharmacokinetic parameters were calculated for amlodipine and lisinopril by the means of Bioequiv 3.5 software using a model independent approach.
Danish: De farmakokinetiske parametre blev beregnet for amlodipin og lisinopril ved hjælp af Bioequiv 3.5 softwaren under anvendelse af en modeluafhængig metode.
English: Amlodipine cannot be removed from the plasma by dialysis.
Danish: Amlodipin kan ikke fjernes fra plasma ved dialyse.
English: It inhibits the influx of calcium into myocardial and vascular smooth muscle cells through the inhibition of slow calcium ion channels of the cell membranes.
Danish: Det hæmmer tilstrømningen af calcium til myokardiet og vaskulære glatmuskelceller via hæmning af de langsomme calciumionkanaler i cellemembranerne.
English: Weight increase, Weight decrease
Danish: Vægtforøgelse, vægttab
English: The angioedema was diagnosed by procedures including CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor.
Danish: Angioødemet blev diagnosticeret via procedurer, der omfattede CT-scanning eller ultralyd eller ved kirurgisk indgreb, og symptomerne ophørte efter, at ACE-hæmmeren var seponeret.
English: Pregnancy and breast-feeding Lisonorm must not be taken during pregnancy and breast-feeding.
Danish: Lisonorm må ikke tages under graviditet og amning.