FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Danish: Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca. 40-60%.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with amlodipine/valsartan.
Danish: Hvis der samtidigt gives et diuretikum, kan risikoen for lithiumtoksicitet muligvis være yderligere øget med amlodipin/valsartan.
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Danish: Administration af amlodipin sammen med grapefrugt eller grapefrugtjuice kan ikke anbefales, da biotilgængeligheden kan øges hos nogle patienter, hvilket kan resultere i en øget blodtrykssænkende effekt.
English: if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for valsartan eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77 % increase in exposure to simvastatin compared to simvastatin alone.
Danish: Samtidig administration af multiple doser af 10 mg amlodipin sammen med 80 mg simvastatin har resulteret i en 77% stigning i eksponeringen for simvastatin sammenlignet med simvastatin alene.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet, reproduktions- og udviklingstoksicitet.
English: See also information under the heading “Do not take Amlodipine/Valsartan Mylan”.
Danish: Se også information under overskriften ”Tag ikke Amlodipine/Valsartan Mylan”.
English: Cellulose microcrystalline
Danish: Mikrokrystallinsk cellulose
English: The safety of amlodipine/valsartan has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Danish: Amlodipin/valsartans sikkerhed er blevet evalueret i fem kontrollerede kliniske studier med 5.175 patienter, hvoraf 2.613 fik valsartan i kombination med amlodipin.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and angiotensin II receptor blockers (ARBs).
Danish: På baggrund af de fælles farmakodynamiske egenskaber er disse resultater også relevante for andre ACE-hæmmere og angiotensin II-receptorhæmmer (ARBer).
English: White high density polyethylene (HDPE) bottle with white opaque polypropylene cap with aluminium induction sealing liner wad.
Danish: Hvid flaske af polyethylen med høj densitet (HDPE) med hvidt, uigennemsigtigt polypropylenlåg med aluminiumsinduktionsforsegling.
English: 320 mg/day and a 60 kg patient).
Danish: 320 mg/dag til en patient, der vejer 60 kg).
English: Patients with high cardiovascular risks - heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year - were excluded.
Danish: Patienter med høje kardiovaskulære risici - hjertesvigt, type I- og dårligt kontrolleret type II-diabetes og en anamnese med myokardieinfarkt eller slagtilfælde inden for det sidste år - blev ekskluderet.
English: Not known (frequency cannot be estimated from the available data): trembling, rigid posture, masklike face, slow movements and a shuffling, unbalanced walk.
Danish: Ikke kendt (hyppigheden kan ikke klarlægges ud fra de tilgængelige data): rysten, stiv kropsholdning, maskeagtigt ansigt, langsomme bevægelser og en slæbende gang ude af balance.
English: Pack sizes: 28, 56 or 98 film-coated tablets.
Danish: Pakningsstørrelser: 28, 56 eller 98 filmovertrukne tabletter.
English: In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Danish: For at undgå toksicitet fra tacrolimus, kræver administrering af amlodipin til en patient, der behandles med tacrolimus, overvågning af blodniveauerne af tacrolimus og dosisjustering af tacrolimus efter behov.
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Danish: Data fra dyrestudier tyder på, at amlodipin binder til både dihydropyridin og ikke- dihydropyridin-bindingssteder.
English: Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure ≥95 and <110 mmHg) were enrolled.
Danish: Voksne med let til moderat ukompliceret essentiel hypertension (middel siddende diastolisk blodtryk ≥95 og <110 mmHg) blev inkluderet.
English: Amlodipine/Valsartan Mylan and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Danish: Amlodipine/Valsartan Mylan og ældre patienter (65 år og derover) Din læge bør udvise forsigtighed, når dosis øges.
English: There is an increased risk of hypotension in patients receiving clarithromycin with amlodipine.
Danish: Der er en øget risiko for hypotension hos patienter, der får clarithromycin sammen med amlodipin.
English: Max. daily dose (mg)
Danish: Maksima l daglig dosis (mg)
English: Amlodipine/valsartan should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Amlodipin/valsartan skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: Amlodipine/valsartan should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Amlodipin/valsartan skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serumkreatinin kan stige hos disse patienter.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1 % with the amlodipine/valsartan combination.
Danish: Den gennemsnitlige incidens af perifert ødem fordelt ligeligt over alle doser var 5,1% med amlodipin/valsartan kombinationen.
English: Do not take Amlodipine/Valsartan Mylan with grapefruit or grapefruit juice.
Danish: Tag ikke Amlodipine/Valsartan Mylan sammen med grapefrugt eller grapefrugtjuice.
English: To date there is no experience of the safe use of amlodipine/valsartan in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af amlodipin/valsartan til patienter, som kort tid forinden har modtaget nyretransplantation.
English: NDEA Limit in ng/day
Danish: NDEA Grænsevær di (ng/dag)
English: Clinically significant hypotension due to amlodipine/valsartan overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering med amlodipin/valsartan kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget en AIIA, skal observeres tæt for hypotension (se pkt.
English: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Danish: Halveringstiden af amlodipin er forlænget og AUC større hos patienter med nedsat leverfunktion; der kan ikke gives nogen anbefaling vedrørende dosering.
English: Amlodipine/valsartan was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Danish: Amlodipin/valsartan er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med middel siddende diastolisk blodtryk ≥110 mmHg og <120 mmHg.
English: Close observation of patients is recommended when amlodipine is co administered with clarithromycin.
Danish: Der anbefales nøje observation af patienter, når amlodipin administreres samtidig med clarithromycin.
English: It is recommended to take Amlodipine/Valsartan Mylan with some water.
Danish: Det anbefales at tage Amlodipine/Valsartan Mylan med lidt vand.
English: Renal impairment There are no available clinical data in severely renally impaired patients.
Danish: Nedsat nyrefunktion Der er ingen tilgængelige kliniske data fra patienter med alvorligt nedsat nyrefunktion.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with amlodipine/valsartan as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Yderligere information om de individuelle komponenter Bivirkninger, som tidligere er indrapporteret for hver enkelt af de individuelle komponenter (amlodipin eller valsartan), kan også være potentielle bivirkninger med amlodipin/valsartan, selv i de tilfælde, hvor de ikke er set i kliniske studier eller i perioden efter markedsføring.
English: Abrupt withdrawal of amlodipine/valsartan has not been associated with a rapid increase in blood pressure.
Danish: Pludselig seponering af amlodipin/valsartan er ikke blevet forbundet med hurtig blodtryksstigning.
English: No dosage adjustment of amlodipine/valsartan is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Danish: Det er ikke nødvendigt at justere dosis af amlodipin/valsartan hos patienter med let til moderat nedsat nyrefunktion (GFR >30 ml/min/1,73 m2).
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4(amlodipine) fold the clinical exposure (based on AUC).
Danish: Niveauet for ingen observerede bivirkninger (NOEL) på den føtale udvikling er set ved 3 (valsartan) og 4 (amlodipin) gange den kliniske eksponering (baseret på AUC).
English: Amlodipine/valsartan has not been studied in any patient population other than hypertension.
Danish: Amlodipin/valsartan er ikke undersøgt i andre patientgrupper end hypertension.
English: Following oral administration of amlodipine/valsartan, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Danish: Efter oral administration af amlodipin/valsartan opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6-8 timer.
English: In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life.
Danish: Amlodipins clearance har tendens til at falde hos ældre patienter, hvilket resulterer i øget areal under kurven (AUC) og øget eliminationshalveringstid.
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Danish: Hæmmere af optagelsestransportøren (rifampicin, ciclosporin) eller effluxtransportøren (ritonavir) Resultatet af et in vitro-studie med humant levervæv indikerede, at valsartan er substrat for den hepatiske optagelsestransportør OATP1B1 og af den hepatiske effluxtransportør MRP2.
English: The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5 %), type 2 diabetes (36.1 %), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6 %), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9 %), current cigarette smoking (21.9 %).
Danish: Patienterne havde mindst én ekstra risikofaktor for koronar hjertelidelse f.eks. tidligere myokardieinfarkt eller apopleksi (>6 måneder før inkludering) eller dokumenteret anden aterosklerotisk kardiovaskulær sygdom (tilsammen 51,5%), type 2-diabetes (36,1%), HDL-kolesterol <35 mg/dl (<0,906 mmol/l) (11,6%), venstre ventrikel-hypertrofi diagnosticeret ved elektrokardiogram eller ekkokardiografi (20,9%), aktuel cigaretrygning (21,9%).
English: Within 2 years after Commission Decision
Danish: Senest to år efter
English: Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2 % versus 7.7 %, RR 1.38, 95 % CI [1.25-1.52] p<0.001).
Danish: Blandt de sekundære endepunkter var incidensen af hjertesvigt (del af et sammensat kardiovaskulært endepunkt) signifikant højere i amlodipin-gruppen sammenlignet med chlorthalidon-gruppen (10,2% versus 7,7%; RR 1,38; 95% KI [1,25-1,52]; p <0,001).
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker (ARB) in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Danish: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) var et studie, der skulle undersøge fordelen ved at tilføje aliskiren til standardbehandling med en ACE-hæmmer eller en angiotensin II-receptorhæmmer (ARB) hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Danish: Hos hypertensive patienter med normal nyrefunktion resulterede terapeutiske doser af amlodipin i en nedsat renal vaskulær modstand med øget glomerulær filtrationshastighed og effektivt renal plasma flow, uden ændring i filtrationsfraktionen eller proteinuri.
English: Swelling of the tongue and throat which causes great difficulty breathing.
Danish: - Hævelse af tunge eller svælg, hvilket kan gøre det meget svært at trække vejret.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning af mistænkte formodede vigtig.
English: Amlodipine/Valsartan Mylan is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets.
Danish: Amlodipine/Valsartan Mylan er tilgængelig i blisterpakninger indeholdende 14, 28, 30, 56, 90 eller 98 tabletter.
English: You should never take Amlodipine/Valsartan Mylan again.
Danish: Du bør aldrig tage Amlodipine/Valsartan Mylan igen.
English: If hypotension occurs with amlodipine/valsartan, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer hypotension med amlodipin/valsartan, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Danish: 28 filmovertrukne tabletter 56 filmovertrukne tabletter 98 filmovertrukne tabletter
English: There is a risk of increased tacrolimus blood levels when co administered with amlodipine.
Danish: Der er en risiko for øget blodniveauer af tacrolimus ved samtidig administrering med amlodipin.
English: Hepatic impairment Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment.
Danish: Der er meget få tilgængelige kliniske data vedrørende amlodipin-administration til patienter med nedsat leverfunktion.
English: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Danish: Samtidig brug af kaliumtilskud, kaliumbesparende diuretika, kaliumholdige salterstatninger eller anden medicin, som øger indholdet af kalium (heparin osv.), skal foretages med forsigtighed og under hyppig monitorering af kaliumniveauet.
English: Extrapyramidal disorder
Danish: Ekstrapyramidal forstyrrelse
English: Amlodipine/Valsartan Mylan combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Danish: Amlodipine/Valsartan Mylan kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister og valsartan tilhører klassen kaldet angiotensin II-antagonister.
English: Bottle:
Danish: Flaske:
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan.
Danish: Der er rapporteret reversibelt forhøjede serumkoncentrationer og toksicitet af lithium ved administration af lithium sammen med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin II-antagonister, inklusive valsartan.
English: Amlodipine/Valsartan Mylan is also available in bottles containing 28, 56 or 98 tablets.
Danish: Amlodipine/Valsartan Mylan findes også i flasker indeholdende 28, 56 eller 98 tabletter.
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6 % versus 7.9 %, respectively).
Danish: I kliniske studier, hvor valsartan blev sammenlignet med en ACE-hæmmer, var incidensen af tør hoste signifikant (p <0,05) mindre hos patienter i behandling med valsartan end hos patienter i behandling med en ACE-hæmmer (henholdsvis 2,6% versus 7,9%).
English: The rate and extent of absorption of amlodipine/valsartan are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Danish: Hastigheden og graden af amlodipin/valsartanabsorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: Mean systemic AUC of valsartan is higher by 70 % in the elderly than in the young, therefore caution is required when increasing the dosage.
Danish: Middel systemisk AUC af valsartan er 70% højere hos ældre end hos yngre.
English: A randomised double-blind morbidity-mortality study called the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACE-inhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.
Danish: Et randomiseret, dobbeltblindet morbiditets-mortalitets studie kaldet ”Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calciumantagonist) eller lisinopril 10-40 mg/dag (ACEhæmmer) som førstevalgsbehandling i stedet for et thiaziddiuretikum, chlorthalidon 12,5-25 mg/dag ved let til moderat hypertension.
English: There is no experience of overdose with amlodipine/valsartan.
Danish: Der er ingen erfaring med overdosering af amlodipin/valsartan.
English: * mostly consistent with cholestasis
Danish: * Oftest som følge af kolestase
English: If you get these symptoms, stop taking Amlodipine/Valsartan Mylan and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Amlodipine/Valsartan Mylan og kontakte din læge med det samme.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Amlodipine/Valsartan Mylan or observed with a higher frequency than with Amlodipine/Valsartan Mylan:
Danish: Bivirkninger, som er rapporteret ved behandling med valsartan og amlodipin alene, og som enten ikke er set ved behandling med Amlodipine/Valsartan Mylan, eller som er set hyppigere end ved behandling med Amlodipine/Valsartan Mylan:
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95 % CI [0.89-1.02] p=0.20.
Danish: Der var dog ingen signifikant forskel på mortalitet af alle årsager mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling, RR 0,96; 95% KI [0,89-1,02]; p=0,20.
English: For bottle packs: After first opening use within 100 days.
Danish: For flasker: Skal anvendes inden for 100 dage efter anbrud.
English: Pack sizes: 14, 14x1 (unit dose), 28, 28x1 (unit dose), 30x1 (unit dose), 56, 56x1 (unit dose), 90x1 (unit dose), 98 or 98x1 (unit dose) film-coated tablets.
Danish: Pakningsstørrelser: 14, 14 x 1 (enkeltdosis), 28, 28 x 1 (enkeltdosis), 30 x 1 (enkeltdosis), 56, 56 x 1 (enkeltdosis), 90 x 1 (enkeltdosis), 98 eller 98 x 1 (enkeltdosis) filmovertrukne tabletter.
English: Linearity Amlodipine and valsartan exhibit linear pharmacokinetics.
Danish: Linearitet Amlodipin og valsartan udviser lineær farmakokinetik.
English: The amlodipine component of Amlodipine/Valsartan Mylan inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Amlodipine/Valsartan Mylan hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: The usual dose of Amlodipine/Valsartan Mylan is one tablet per day.
Danish: Den sædvanlige dosis af Amlodipine/Valsartan Mylan er én tablet dagligt.
English: Do not take Amlodipine/Valsartan Mylan: if you are allergic to amlodipine or to any other calcium channel blockers.
Danish: Tag ikke Amlodipine/Valsartan Mylan - hvis du er allergisk over for amlodipin eller andre calciumantagonister.
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure.
Danish: Samtidig administration af kraftige eller moderate CYP3A4-hæmmere (proteasehæmmere, svampemidler af azoltypen, makrolider som f.eks. erythromycin samt verapamil og diltiazem) kan give anledning til signifikant stigning i amlodipins plasmakoncentration.
English: NDMA Limit in ng/day
Danish: NDMA Grænsev ærdi (ng/dag)
English: If you take more Amlodipine/Valsartan Mylan than you should If you have taken too many tablets of Amlodipine/Valsartan Mylan, or if someone else has taken your tablets, consult a doctor immediately.
Danish: Hvis du har taget for meget Amlodipine/Valsartan Mylan Hvis du har taget for mange Amlodipine/Valsartan Mylan-tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
English: The safety and efficacy of amlodipine/valsartan in children aged below 18 years have not been established.
Danish: Amlodipin/valsartans sikkerhed og virkning hos børn under 18 år er ikke klarlagt.