FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant provided these pharmacokinetic results for amlodipine and lisinopril along with semi-logarithmic mean plasma concentration-time curves.
Danish: Ansøgeren fremlagde disse farmakokinetiske resultater for amlodipin og lisinopril sammen med semi-logaritmiske gennemsnitstidskurver for plasmakoncentrationen.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Lisinorm til andre.
English: Antidiabetics: Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicinal products (insulins, oral hypoglycaemic agents) may cause an increased blood glucose lowering effect with risk of hypoglycaemia.
Danish: Antidiabetika: Epidemiologiske undersøgelser har tydet på, at samtidig administration af ACEhæmmere og antidiabetika (insuliner, orale hypoglykæmiske midler) kan medføre øget blodglucosesænkende virkning med risiko for hypoglykæmi.
English: Lisonorm 10mg/5mg 10 mg/5 mg tablets oral use
Danish: Lisonorm 10mg/5mg 10 mg / 5 mg tabletter oral anvendelse
English: ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Danish: ACE-hæmmer-induceret hoste bør betragtes som en del af den differentiale diagnosticering af hoste.
English: These life-threatening reactions can be avoided by temporary withdrawal of ACE inhibitor therapy.
Danish: Disse livstruende reaktioner kan undgås ved midlertidig seponering af ACE-hæmmer-behandlingen.
English: This is especially likely in patients with renal insufficiency.
Danish: Dette er specielt sandsynligt hos patienter med nyreinsufficiens.
English: NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Danish: NSAID'er og ACE-hæmmere har en additiv effekt på forhøjelsen af serumkalium og kan medføre en nedsættelse af nyrefunktionen.
English: Patients receiving Lisonorm tablets who develop jaundice or marked elevations of hepatic enzymes should discontinue Lisonorm and receive appropriate medical follow-up.
Danish: Patienter, der får Lisonorm-tabletter, og som udvikler gulsot eller markant forhøjede leverenzymværdier, bør have seponeret Lisonorm og få passende medicinsk opfølgning.
English: Teratogenic or other embrio/fetotoxic effects were not found in rats and rabbits given up to 10 mg/kg amlodipine (8 times and 23 times, respectively, the maximum recommended human daily dose of 10 mg on a mg/m2 basis) during gestation.
Danish: Teratogene eller andre embryo-/føtotoksiske virkninger blev ikke fundet hos rotter og kaniner, der fik op til 10 mg/kg amlodipin (henholdsvis 8 gange og 23 gange den maksimalt anbefalede daglige humane dosis på 10 mg på en mg/m2 basis) i drægtighedsperioden.
English: Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when angiotensin converting enzyme inhibitors has been given concomitantly with a diuretic.
Danish: Visse hypertensive patienter uden nogen åbenbar præeksisterende vaskulær nyrelidelse har udviklet forhøjet blodurea og serumkreatinin, i reglen mindre og forbigående, specielt når der er indgivet angiotensinkonverterende enzymhæmmere samtidigt med et diuretikum.
English: Substantial decrease in blood pressure and hence symptomatic hypotension can occur in patients with volume and/or sodium depletion resulting from diuretic therapy, fluid loss of other origin such as excessive diaphoresis, prolonged vomiting and/or diarrhoea (see section 4.2).
Danish: Substantielt blodtryksfald og derfor symptomatisk hypotension kan forekomme hos patienter med volumen- og/eller natriummangel som følge af behandling med diuretikum, væsketab af anden oprindelse, såsom for kraftig diaforese, længere tids opkastning og/eller diarré (se punkt 4.2).
English: In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, lisinopril may block angiotensin II formation secondary to compensatory renin release.
Danish: Hos patienter, der gennemgår større kirurgiske indgreb, eller som er under anæstesi med midler, der fremkalder hypotension, kan lisinopril blokere angiotensin II-dannelse sekundært til den kompensatoriske renin-frigørelse.
English: Allopurinol, procainamide, cytostatics or immunosuppressive agents (systemic corticosteroids) may lead to an increased risk of leukopenia when administered concomitantly with ACE inhibitors.
Danish: Allopurinol, procainamid, cytostatika eller immunsuppressiva (systemiske corticosteroider) kan medføre øget risiko for leukopeni ved samtidig administration af ACE-hæmmere.
English: • anaesthetics, used in surgery or some dental procedures.
Danish: • bedøvende midler (anæstetika), bruges ved operationer eller visse tandlægebehandlinger.
English: Packs contain 30 tablets in white, opaque PVC/PE/PVDC-aluminium blisters.
Danish: Pakningen indeholder 30 tabletter i hvide, uigennemsigtige PVC/PE/PVDCaluminiumblisterpakninger.
English: A syndrome has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, positive ANA, elevated ESR value, eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations.
Danish: Der er indberettet et syndrom, der kan omfatte en eller flere af følgende lidelser: feber, vasculitis, myalgi, artralgi/artritis, positiv ANA, forhøjet ESRværdi, eosinofili og leukocytose, udslæt, fotosensitivitet eller andre dermatologiske manifestationer.
English: - swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.
Danish: - hævelse af ansigt, læber, tunge og/eller svælg, der kan medføre synkebesvær.
English: Fertility was not affected in female and male rats in doses up to 300 mg/kg (33 times the maximum recommended human daily dose when compared on a body surface area).
Danish: Fertiliteten blev ikke påvirket hos hun- og hanrotter ved doser på op til 300 mg/kg (33 gange den maksimalt anbefalede daglige humane dosis ved sammenligning baseret på kropsoverfladeareal).
English: • autonomous nervous system stimulants (sympathomimetics), such as ephedrine, phenylephrine,
Danish: • stimulanser af det autonome nervesystem (sympatomimetika), såsom efedrin, fenylefrin
English: Bronchospasm, Allergic alveolitis/Eosinophilic pneumonia, Sinusitis
Danish: Meget sjældent Bronkospasme, Allergisk alveolitis/eosinofil pneumoni, sinusitis
English: Amlodipine is transformed into inactive metabolites in the liver primarily, with 10 % of the unchanged parent compound excreted in the urine.
Danish: Amlodipin omdannes til inaktive metabolitter i leveren primært med 10 % af den uændrede modersubstans udskilt i urinen.
English: Interactions related to lisinopril
Danish: Interaktioner relateret til lisinopril
English: These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Danish: Disse reaktioner blev undgået ved en temporær seponering af ACE-hæmmer-behandlingen forud for hver aferese.
English: ADRs with amlodipine
Danish: ADR med amlodipin
English: Potassium-sparing diuretics (such as spironolactone, amiloride, triamterene, used to reduce fluid retention) may only be taken together with Lisonorm under close medical supervision.
Danish: Kaliumbesparende diuretika (såsom spironolacton, amilorid, triamteren, der bruges til at reducere væskeophobning) kan også tages sammen med Lisonorm under tæt overvågning af en læge.
English: • Hypersensitivity to lisinopril or to any other angiotensin converting enzyme (ACE) inhibitor.
Danish: • Overfølsomhed over for lisinopril eller noget andet angiotensinkonverterende enzym (ACE)
English: Adverse reactions were consistent with those reported previously with amlodipine and/or lisinopril.
Danish: Bivirkningerne var overensstemmende med det, der tidligere er rapporteret med amlodipin og/eller lisinopril.
English: Amlodipine is extensively metabolized by the liver to inactive metabolites with 10 % of the unchanged parent compound and 60 % of metabolites are excreted in the urine.
Danish: Amlodipin metaboliseres i vidt omfang i leveren til inaktive metabolitter med 10 % af den uændrede modersubstans, og 60 % af metabolitterne udskilles via urinen.
English: Hepatitis, Jaundice, Cholestasis
Danish: Hepatitis, gulsot, cholestase
English: • allupurinol, used to treat gout
Danish: • allupurinol, bruges til behandling af gigt
English: In hyperglycaemic patients, lisinopril contributes to the restoration of impaired endothelial function.
Danish: Hos hyperglykæmiske patienter bidrager lisinopril til genetablering af en nedsat endotelial funktion.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Den epidemiologiske evidens vedrørende risikoen for teratogenicitet efter eksponering for ACEhæmmere under første trimester af graviditeten har ikke været sikker.
English: Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis Rarely, patients receiving ACE inhibitors during low-density lipoproteins (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions.
Danish: Anafylaktoide reaktioner under lav-densitets lipoprotein- (LDL) aferese Det er sket i sjældne tilfælde, at patienter, der fik ACE-hæmmere under lav-densitets lipoprotein(LDL) aferese med dextransulfat har oplevet livstruende anafylaktoide reaktioner.
English: When advanced age is associated with decrease in renal function Lisonorm dose adjustments for patients with renal impairment apply (see section 4.2).
Danish: Hvis den fremskredne alder er associeret med nedsat nyrefunktion, skal de gældende anvisninger om dosisjusteringer af Lisonorm til patienter med nedsat nyrefunktion følges (se punkt 4.2).
English: Whereas - the Applicant has submitted a bioequivalence study, No. 67289, which shows that the test product induces comparable PK profiles for amlodipine and lisinopril in the fixed dose combination to those of the reference products (monocomponents).
Danish: Ud fra følgende betragtninger: - Ansøgeren har fremlagt resultaterne af en bioækvivalensundersøgelse, nr. 67289, som viser, at undersøgelseslægemidlet giver PK-profiler for amlodipin og lisinopril i fastdosiskombination, som er sammenlignelige med værdierne for referencelægemidlerne (monokomponenter).
English: Amlodipine at this dose level prolonged both the gestation and labour duration.
Danish: Amlodipin ved dette dosisniveau forlængede både drægtighedsperioden og selve fødslen.
English: Hepatic failure, Hepatitis, Cholestatic jaundice, (see section 4.4)
Danish: Meget sjældent Leversvigt, hepatitis, cholestatisk gulsot, (se punkt 4.4)
English: Consequently, Lisonorm is contraindicated in pregnancy (see section 4.3).
Danish: Følgelig er Lisonorm kontraindiceret under graviditet (se punkt
English: Very rarely, neutropenia, agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors (see section 4.8).
Danish: Der er i yderst sjældne tilfælde indberettet neutropeni, agranulocytose, trombocytopeni og anæmi hos patienter, der fik ACE-hæmmere (se punkt 4.8).
English: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including lisinopril.
Danish: Angioødem i ansigt, ekstremiteter, læber, tunge, glottis og/eller larynx er blevet indberettet hos patienter behandlet med ACE-hæmmere, herunder lisinopril.
English: Others: In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, antiacid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non-steroidal antiinflammatory medicines, antibiotics and oral hypoglycaemic medicines.
Danish: Andet: Ved monoterapi er amlodipin blevet sikkert administreret sammen med thiaziddiuretika, betablokkere, ACE-hæmmere, langtidsvirkende nitrater, sublingval nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, antacida (aluminiumhydroxidgel, magnesiumhydroxid, simeticon), cimetidin, non-steroide anti-inflammatoriske lægemidler, antibiotika og orale hypoglykæmiske lægemidler.
English: • A history of angioedema relating to previous ACE inhibitor therapy.
Danish: • Angioødem med relation til tidligere ACE-hæmmerterapi i anamnesen.
English: Fixed dose combination
Danish: Fastdosis-kombination
English: - the safety profile of the test product shows no differences with respect to adverse events associated with the administration of amlodipine and lisinopril compared to either reference treatments.
Danish: - Undersøgelseslægemidlets sikkerhedsprofil udviser ikke nogen forskelle med hensyn til bivirkninger i forbindelse med administration af amlodipin og lisinopril sammenlignet med hver af referencebehandlingerne.
English: Substances affecting potassium levels: Potassium-sparing diuretics (e.g. spironolactone, amiloride, and triamterene), potassium supplements, or potassium-containing salt substitutes and other substances that may increase potassium levels (e.g. heparin) can lead to hyperkalaemia in combination with ACE inhibitors, particularly in patients with renal impairment and other pre-existing conditions (see section 4.4).
Danish: Stoffer, der påvirker kaliumniveauerne: Kaliumbesparende diuretika (f.eks. spironolakton, amilorid og triamteren), kaliumtilskud eller kaliumholdige saltsubstitutionsmidler og andre stoffer, der kan øge kaliumniveauerne (f.eks. heparin), kan medføre hyperkalæmi i kombination med ACE-hæmmere, specielt hos patienter med nedsat nyrefunktion og andre præeksisterende tilstande (se punkt 4.4).
English: [To be completed nationally] [See Annex I - To be completed nationally]
Danish: [Udfyldes nationalt] [Se Bilag I - Skal udfærdiges nationalt]
English: 6.5 Nature and contents of container 30 tablets in white, opaque PVC/PE/PVDC/Aluminium blisters.
Danish: 6.5 Emballagetype og pakningsstørrelse 30 tabletter i hvide, uigennemsigtige PVC/PE/PVDC-aluminiumblisterpakninger.
English: • herbal preparations containing St. John's wort (Hypericum perforatum)
Danish: • helsekostpræparater med prikbladet perikum (Hypericum perforatum)
English: Impotence, Gynaecomastia
Danish: Impotens, gynækomasti
English: Uncommon Hypersensitivity/angioedem a of the face, extremities, lips, tongue, glottis and/or larynx (see section 4.4), Rash, Pruritus
Danish: Hypersensitivitet/angioødem i ansigtet, ekstremiteterne, læber, tunge, glottis og/eller larynx (se punkt 4.4), udslæt, pruritus
English: Deterioration of blood-picture: decrease of red blood cells, of platelets (thrombocytopenia), of white blood cells (neutropenia, leucopenia, agranulocytosis).
Danish: Forværrede blodværdier: Nedsat antal røde blodlegemer, blodplader (trombocytopeni), hvide blodlegemer (neutropeni, leukopeni, agranulocytose).
English: Therefore, the Applicant acknowledged the limitations arising from the product selection in the initial pivotal BE study and performed a study (Protocol No 67289) to investigate bioequivalence of LISONORM FORTE (fixed-combination of amlodipine 10 mg and lisinopril 20 mg), co-administration of NORVASC 10 mg (containing amlodipine 10 mg) and PRINIVIL 20 mg (containing lisinopril 20 mg), and LISONORM (fixed-combination of amlodipine 5 mg and lisinopril 10 mg) under fasting conditions.
Danish: Derfor anerkendte ansøgeren de begrænsninger, der opstod ved produktvalget i den indledende centrale BE-undersøgelse, og gennemførte en undersøgelse (Protokol nr. 67289) med henblik på at undersøge bioækvivalensen af LISONORM FORTE (fast kombination af amlodipin 10 mg og lisinopril 20 mg), samtidig administration af NORVASC 10 mg (indeholdende amlodipin 10 mg) og PRINIVIL 20 mg (indeholdende lisinopril 20 mg) og LISONORM (fast kombination af amlodipin 5 mg og lisinopril 10 mg) under fastende betingelser.
English: Elevations in potassium serum levels have been observed in some patients treated with ACE inhibitors.
Danish: Forhøjede kaliumserumniveauer er observeret hos nogle af de patienter, der blev behandlet med ACEhæmmere.
English: ADRs with lisinopril
Danish: ADR med lisinopril
English: Amlodipine is a dihydropyridine-type calcium channel blocker.
Danish: Amlodipin er en calciumkanalblokker af dihydropyridine-typen.
English: The following adverse drug reactions (ADRs) have been reported during the treatment with lisinopril and amlodipine independently :
Danish: Følgende bivirkninger (ADR) er indberettet under behandling med lisinopril og amlodipin uafhængigt af hinanden:
English: In controlled clinical trials, the following adverse reactions were reported in ≥ 1% of patients with either concomitantly administered amlodipine plus lisinopril or with amlodipine and lisinopril monotherapies (see Table below):
Danish: I kontrollerede kliniske forsøg indberettedes følgende bivirkninger hos ≥ 1 % af patienterne ved enten samtidigt administreret amlodipin plus lisinopril eller ved amlodipin og lisinopril monoterapier (se nedenstående tabel):
English: Anaphylactoid reactions in haemodialysis patients
Danish: Anafylaktoide reaktioner hos hæmodialyserede patienter
English: Surgery/general anaesthesia
Danish: Kirurgiske indgreb/generel anæstesi
English: CYP3A4 inducers: Co-administration with anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort/Hypericum perforatum) may lead to reduced plasma concentrations of amlodipine.
Danish: CYP3A4-induktorer: Samtidig administration af antikonvulsiva (f.eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon), rifampicin, helsekostpræparater, der indeholder prikbladet perikum) kan medføre reducerede plasmakoncentrationer af amlodipin.
English: Lisinopril can be removed from the plasma by dialysis.
Danish: Lisinopril kan fjernes fra plasma ved dialyse.
English: Erythema multiforme, Angioedema, Urticaria
Danish: Erythema multiforme, angioødem, urtikaria
English: Overdose can result in excessive peripheral vasodilatation with marked hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Danish: Overdosering kan medføre kraftig perifer vasodilatation med markant hypotension, kredsløbschok, elektrolytforstyrrelser, nyresvigt, hyperventilation, takykardi, palpitationer, bradykardi, svimmelhed, angst og hoste.
English: The bioavailability of amlodipine is 64 to 80 %; its volume of distribution is approximately 20 l/kg.
Danish: Biotilgængeligheden for amlodipin er 64 til 80 %.
English: Additional side effects that have been reported with either amlodipine or lisinopril alone (the two active substances), and may also occur with Lisonorm are the following:
Danish: Yderligere bivirkninger, der er rapporteret med de to aktive stoffer i tabletterne hver for sig (amlodipin og lisinopril), og som også kan forekomme med Lisonorm, er følgende:
English: Based on the data provided, bioequivalence for both amlodipine 10 mg and lisinopril 20 mg after administration of single oral doses of LISONORM FORTE, co-administration of NORVASC 10 mg and PRINIVIL 20 mg, or administration of LISONORM (fixed-combination of amlodipine 5 mg and lisinopril 10 mg) could be concluded.
Danish: Baseret på de indbragte data kunne bioækvivalens for både amlodipin 10 mg og lisinopril 20 mg efter administration af enkelte orale doser af LISONORM FORTE, samtidig administration af NORVASC 10 mg og PRINIVIL 20 mg eller administration af LISONORM (fast kombination af amlodipin 5 mg og lisinopril 10 mg) udledes.
English: Store below 25°C.
Danish: Skal opbevares ved temperaturer under 25 °C.
English: Insomnia, Mood altered
Danish: Insomni, stemningsændring
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se Bilag I - Skal udfærdiges nationalt]
English: Lisonorm is a new fixed-dose combination containing 10mg lisinopril (an ACE inhibitor) and 5mg amlodipine (a calcium antagonist), indicated for patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Danish: Lisonorm er en ny fastdosis kombination, der indeholder 10 mg lisinopril (en ACE-hæmmer) og 5 mg amlodipin (en calcium-antagonist), indiceret til patienter med et blodtryk, som er tilstrækkeligt reguleret med lisinopril og amlodipin indgivet samtidigt ved samme dosisniveau.
English: Common side effects in a clinical trial with Lisonorm tablets were: headache, cough, dizziness, palpitations (a quicker or irregular heart beat), and pruritus.
Danish: Almindelige bivirkninger i et klinisk forsøg med Lisonorm var følgende: Hovedpine, hoste, svimmelhed, palpitationer (en hurtigere eller uregelmæssig puls) og kløe.
English: In the case of renal function deterioration, the use of Lisonorm should be discontinued and replaced by the individual components adequately adjusted.
Danish: I tilfælde af, at nyrefunktionen forringes, skal Lisonorm seponeres og erstattes af de enkelte indholdsstoffer i tilstrækkelig dosering.
English: xylometazoline and salbutamol, used to treat congestion, cough, cold and asthma.
Danish: • medicintyperne xylometazolin og salbutamol, bruges til at behandle blodansamlinger, hoste og astma
English: What LISONORM contains - The active substances are lisinopril and amlodipine.
Danish: Hvad Lisonorm indeholder - De aktive stoffer er lisinopril og amlodipin.
English: Lisonorm tablet is a combination product of amlodipine, which belongs to a group of medicines called calcium channel blockers, and lisinopril, which belongs to a group of medicines called angiotensinconverting enzyme (ACE) inhibitors.
Danish: Amlodipin tilhører en medicingruppe kaldet calciumkanalblokkere, og lisinopril tilhører en medicingruppe kaldet angiotensinkonverterende enzymhæmmere (ACE-hæmmere).
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Dyspnoea, Rhinitis
Danish: Dyspnø, rhinitis
English: ACE inhibitors therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Eksponering for behandling med ACE-hæmmere under andet og tredje trimester vides at inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi).
English: Member State Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelsen
English: The gastrointestinal absorption of Lisonorm is not influenced by food.
Danish: Absorptionen af Lisonorm i mavetarmkanalen påvirkes ikke af føde.
English: In the case of renal function deterioration, Lisonorm should be withdrawn and replaced by the therapy with individual components adequately adjusted.
Danish: I tilfælde af nedsættelse af nyrefunktionen skal Lisonorm seponeres og erstattes af behandling med de enkelte indholdsstoffer i tilstrækkelig dosering.
English: Pancreatitis, Intestinal angioedema
Danish: Meget sjældent Pankreatitis, intestinalt angioødem
English: In some patients with bilateral renal artery stenosis or with a stenosis of the artery to a solitary kidney, who have been treated with angiotensin converting enzyme inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.
Danish: Hos visse patienter med bilateral nyrearteriestenose eller med stenose i arterien til en enkelt nyre, der er blevet behandlet med ACE-hæmmere, er der observeret forhøjet blodurea og serumkreatinin, i reglen ved seponering af behandlingen.