FrancophonIA/ELRC3.0 huggingface dataset:
English: Take special care with Imprida HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Danish: Vær ekstra forsigtig med at tage Imprida HCT - hvis du har et lavt niveau af kalium eller magnesium i blodet (med eller uden symptomer som fx muskelsvaghed, muskelkramper, unormal hjerterytme).
English: • swelling, reddening and pain along a vein
Danish: • hævelse, rødmen og smerte langs en blodåre
English: Reproductive toxicology
Danish: Reproduktionstoksikologi
English: Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
Danish: Når valsartan gives til patienter med hypertension, sker der et fald i blodtrykket uden påvirkning af pulsen.
English: The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness.
Danish: Det væsentligste symptom på overdosering af valsartan er risikoen for udtalt hypotension med svimmelhed.
English: Imprida HCT combines three 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 and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Danish: Imprida HCT kombinerer tre antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister, valsartan tilhører klassen kaldet angiotensin II-antagonister og hydrochlorthiazid tilhører klassen kaldet thiazid-diuretika.
English: Valsartan Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir)
Danish: Valsartan Hæmmere af optagelsestransportøren (rifampicin, ciclosporin) eller effluxtransportøren (ritonavir)
English: In a subgroup of 283 patients focusing on ambulatory blood pressure monitoring, clinically and statistically superior reductions in 24-hour systolic and diastolic blood pressures were observed with the triple combination compared to valsartan/hydrochlorothiazide, valsartan/amlodipine, and hydrochlorothiazide/amlodipine.
Danish: I en undergruppe med 283 patienter, hvor der blev fokuseret på ambulatorisk blodtryksmonitorering, blev der observeret klinisk og statistisk større reduktioner i 24-timers systolisk og diastolisk blodtryk ved trippelkombinationsbehandlingen sammenlignet med valsartan/hydrochlorthiazid, valsartan/amlodipin, og hydrochlorthiazid/amlodipin.
English: Hydrochlorothiazide, a sulphonamide, has been associated with an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma.
Danish: Hydrochlorthiazid, som er et sulfonamid, er blevet relateret til en idiosynkratisk reaktion, som kan resultere i akut forbigående myopi og akut lukketvinklet glaukom.
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol.
Danish: Absorptionen af thiaziddiuretika inklusive hydrochlorthiazid nedsættes af colestyramin og colestipol.
English: • inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
Danish: • betændelse i blodårer med symptomer som fx udslæt, purpurrøde pletter, feber (vaskulitis)
English: if you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of Imprida HCT (see section 6, “What Imprida HCT contains”).
Danish: - hvis du er overfølsom (allergisk) over for amlodipin, valsartan, hydrochlorthiazid, sulfonamid afledte stoffer (medicin, som bruges til at behandle infektioner i brystet eller urinvejene), eller et af de øvrige indholdsstoffer i Imprida HCT (se pkt.
English: • angioedema: swelling of face or lips or tongue, difficulty of breathing
Danish: • angioødem: hævet ansigt, læber eller tunge, svært ved at trække vejret,
English: The safety of Imprida HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Danish: Sikkerheden af Imprida HCT er blevet vurderet ved den maksimale dosis på 10 mg/320 mg/25 mg i et kontrolleret, kortvarigt (8 uger) klinisk forsøg med 2.271 patienter, af hvilke 582 fik valsartan i kombination med amlodipin og hydrochlorthiazid.
English: The maximum recommended dose of Imprida HCT is 10 mg/320 mg/25 mg.
Danish: Den maksimalt anbefalede dosis af Imprida HCT er 10 mg/320 mg/25 mg.
English: Manufacturer Novartis Pharma GmbH Roonstraße 25
Danish: Fremstiller Novartis Pharma GmbH Roonstraße 25
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Danish: Hos rotter medførte toksiske doser (600 mg/kg/dag) til moderen i de sidste dage af drægtighedsperioden samt i dieperioden lavere overlevelse, lavere vægtforøgelse og forsinket udvikling (pinna-løsning og åbning af øregang) hos ungerne (se pkt.
English: Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Danish: Thiazider, herunder hydrochlorthiazid, kan nedsætte den renale ekskretion af cytotoksiske midler (fx cyclophosphamid, methotrexat) og forstærke deres myelosuppressive virkning.
English: Caution is indicated in long-term administration of these
Danish: Forsigtighed skal iagttages ved langtidsbehandling med disse lægemidler.
English: • medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics;
Danish: • medicin, som kan nedsætte mængden af natrium i dit blod, såsom antidepressiva,
English: thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Danish: --sitet, hvorved elektrolytreabsorptionsmekanismerne påvirkes: direkte virkning gennem øgning af natrium- og chloridudskillelsen i omtrent samme omfang, og indirekte virkning gennem den diuretiske effekt, der reducerer plasmavolumenet med deraf følgende stigninger i plasmareninaktivitet, aldosteronudskillelse og kaliumtab i urin samt en reduktion i serumkalium.
English: Imprida HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.
Danish: Imprida HCT tabletter indeholder tre stoffer, som kaldes amlodipin, valsartan og hydrochlorthiazid.
English: No formal interaction studies with other medicinal products were performed with Imprida HCT.
Danish: Der er ikke udført formelle interaktionsstudier af Imprida HCT i kombination med andre lægemidler.
English: In the presence of renal impairment, mean peak plasma levels and AUC values of hydrochlorothiazide are increased and the urinary excretion rate is reduced.
Danish: Ved nedsat nyrefunktion er den gennemsnitlige peak-plasmakoncentration og AUC-værdi for hydrochlorthiazid øget, og udskillelsen i urinen er nedsat.
English: • low level of white blood cells and blood platelets
Danish: • lavt antal hvide blodlegemer og blodplader
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, 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 og clarithromycin samt verapamil og diltiazem) kan give anledning til signifikant stigning i amlodipins plasmakoncentration.
English: The triple combination therapy was statistically superior to each of the three dual combination treatments in reduction of diastolic and systolic blood pressures.
Danish: Trippelkombinationsbehandlingen var statistisk set bedre til at reducere systolisk og diastolisk blodtryk, end hver af de tre kombinationsbehandlinger med to stoffer.
English: These include potassium supplements or salt substitutes containing potassium, potassiumsparing medicines and heparin.
Danish: Dette omfatter kaliumtilskud eller salterstatninger, der indeholder kalium, kaliumbesparende medicin og heparin.
English: When Imprida HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Danish: Når Imprida HCT anvendes hos patienter med nedsat nyrefunktion, anbefales regelmæssig monitorering af serumelektrolytter herunder kalium, samt serum-kreatinin og serum-urinsyre.
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: Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Danish: Administration af thiaziddiuretika, herunder hydrochlorthiazid, sammen med D-vitamin eller calciumsalte kan forstærke stigningen i serumcalcium.
English: Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function.
Danish: Thiaziddiuretika bør administreres med forsigtighed til patienter med tilstande, som indebærer øget kaliumtab, fx nefropatier, der giver salttab, og præ-renal (kardiogen) nedsættelse af nyrefunktionen.
English: Concomitant use of thiazide type diuretics may lead to hypercalcaemia in patients pre-disposed for hypercalcaemia (e.g. hyperparathyroidism, malignancy or vitamin-D-mediated conditions) by increasing tubular calcium reabsorption.
Danish: Samtidig brug af thiaziddiuretika kan medføre hyperkalcæmi hos patienter, som er prædisponerede for hyperkalcæmi (fx hyperparathyroidisme, maligne sygdomme eller D-vitamin-medierede forhold) ved at øge den tubulære reabsorption af calcium.
English: Investigations
Danish: Studier
English: Hydrochlorothiazide may reduce the response to pressor amines such as noradrenaline.
Danish: Hydrochlorthiazid kan hæmme virkningen af karkontraherende aminer såsom noradrenalin.
English: • increase of urea nitrogen, creatinine and uric acid in the blood
Danish: • forøget indhold af urinstof, kreatinin og urinsyre i blodet
English: • breast enlargement in men
Danish: • brystforstørrelse hos mænd
English: Abdominal discomfort, abdominal pain upper
Danish: Abdominalt ubehag, øvre mavesmerter
English: Clinical monitoring and dose adjustment may thus be required.
Danish: Monitorering og dosisjustering kan være
English: In case severe or rapid hyponatraemia develops during Imprida HCT therapy, the treatment should be discontinued until normalisation of natraemia.
Danish: Hvis svær eller pludselig hyponatriæmi opstår under behandling med Imprida HCT, bør behandlingen seponeres, indtil natriumbalancen er normaliseret.
English: • dizziness, fainting on standing up
Danish: • svimmelhed eller besvimelse, når man rejser sig
English: Valsartan Others (cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide)
Danish: Valsartan Andre (cimitiden, warfarin, furosemid, digoxin, atenolol, indometacin, hydrochlorthiazid, amlodipin, glibenclamid)
English: There is limited experience with the use of Imprida HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Danish: Der er begrænset erfaring med brug af Imprida HCT til patienter med hjertesvigt og lidelser i kranspulsåren, især med den maksimale dosis.
English: Imprida HCT individual component
Danish: Imprida HCT enkelte komponenter
English: • impotence
Danish: • impotens
English: In patients with mild to moderate renal impairment, a 3-fold increase in hydrochlorothiazide AUC has been observed.
Danish: Hos patienter med let til moderat nedsat nyrefunktion er en 3 gange større AUC-værdi for hydrochlorthiazid observeret.
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products.
Danish: Kontraststoffer med iod I tilfælde af diuretikuminduceret dehydrering er der en øget risiko for akut nyresvigt, særlig ved høje doser af iodpræparat.
English: CARTON OF UNIT PACK
Danish: KARTON TIL ENKELTPAKNINGER
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors and thiazides such as hydrochlorothiazide.
Danish: Der er rapporteret reversible øgede serumkoncentrationer af lithium og toksicitet ved samtidig brug af ACEhæmmere og thiazider som fx hydrochlorthiazid.
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Imprida HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents.
Danish: Ændringerne i laboratorieværdier, som blev set i det kontrollerede kliniske forsøg af 8 ugers varighed, var små og i overensstemmelse med de farmakologiske virkningsmekanisme for komponenterne i monoterapi.
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid.
Danish: Thiaziddiuretika, herunder hydrochlorthiazid, kan ændre glucosetolerancen og forhøje serumværdier af kolesterol, triglycerider og urinsyre.
English: Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Danish: Det er rapporteret, at thiaziddiuretika, herunder hydrochlorthiazid, kan forværre eller aktivere systemisk lupus erythematosus.
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Danish: Som konsekvens af hæmningen af renin-angiotensin-aldosteron-systemet er der risiko for ændringer i nyrefunktionen hos særligt udsatte patienter.
English: • liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine
Danish: • leversygdom, der kan opstå sammen med gulfarvning af hud og øjne, eller mørk farvet urin
English: 280 film-coated tablets
Danish: 280 filmovertrukne tabletter
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Det frarådes at bruge angiotensin II-antagonister (AIIA) i første trimester af en graviditet (se pkt.
English: • severely decreased urine output
Danish: • svært nedsat vandladning
English: If you take more Imprida HCT than you should If you have accidentally taken too many Imprida HCT tablets, talk to a doctor immediately.You may require medical attention.
Danish: Hvis du ved et uheld har taget for mange Imprida HCT-tabletter, skal du straks kontakte en læge.
English: If hypokalaemia develops during hydrochlorothiazide therapy, Imprida HCT should be discontinued until stable correction of the potassium balance.
Danish: Hvis hypokaliæmi opstår under behandling med hydrochlorthiazid, bør Imprida HCT seponeres, indtil kaliumbalancen er genoprettet og stabil.
English: Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricaemia as well as precipitate gout in susceptible patients.
Danish: Hydrochlorthiazid kan muligvis øge serumurinsyre på grund af nedsat urinsyreclearance og udløse eller forværre hyperurikæmi, ligesom det kan forårsage arthritis urica hos følsomme patienter.
English: 280 x 1 film-coated tablet (unit dose)
Danish: 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Impotence
Danish: Impotens
English: • inflammation of the stomach lining or of the pancreas, gingival overgrowth, abnormal liver function test
Danish: • betændelse i maveslimhinden eller i bugspytkirtlen, overvækst af tandkødet, unormale værdier af leverfunktionstest
English: There is no relevant use of Imprida HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Danish: Det er ikke relevant at bruge Imprida HCT til behandling af essential hypertension hos patienter under 18 år.
English: Serum electrolyte changes
Danish: Ændringer i serumelektrolytter
English: if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
Danish: - hvis du har et højt niveau af calcium i blodet (med eller uden symptomer som fx kvalme, opkastning, forstoppelse, mavesmerter, hyppig vandladning, tørst, muskelsvaghed ogtrækninger.
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Imprida HCT.
Danish: Du må ikke indtage grapefrugt og grapefrugtjuice, mens du tager Imprida HCT.
English: Dantrolene (infusion) In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Danish: Hos dyr er der set letal ventrikelflimren og kardiovaskulært kollaps i forbindelse med hyperkaliæmi efter indgift af verapamil og dantrolen i.v.
English: Very rare Very rare
Danish: Meget sjælden Meget sjælden
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain (valsartan), combinations with dihydropyridine derivatives (amlodipine) and thiazide diuretics (hydrochlorothiazide), ATC code: C09DX01 valsartan, amlodipine and hydrochlorothiazide.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonist, almindelig (valsartan), kombination med dihydropyridinderivater (amlodipin) og thiazid diuretika (hydrochlorthiazid), ATC-kode: C09DX01 valsartan, amlodipin og hydrochlorthiazid.
English: Treatment with Imprida HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Danish: Behandling med Imprida HCT bør kun påbegyndes efter korrektion af hypokaliæmi og eventuel samtidig forekommende hypomagnesiæmi.
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Danish: I prækliniske sikkerhedsstudier med rotter forårsagede høje doser valsartan (200-600 mg/kg legemsvægt) reduktion af blodtal (erytrocytter, hæmoglobin og hæmatokritværdi) og tegn på ændringer i den renale hæmodynamik (lettere forhøjet plasma-urinstof, samt renal tubulær hyperplasi og basofili hos hanner).
English: Concomitant treatment with ciclosporin may increase the risk of hyperuricaemia and gout-type complications.
Danish: Anvendelse samtidig med ciclosporin kan øge risikoen for hyperurikæmi og arthritis urica-lignende komplikationer.
English: 56 x 1 film-coated tablet (unit dose) 90 film-coated tablets
Danish: 56 x 1 filmovertrukket tablet (enhedsdosis) 90 filmovertrukne tabletter
English: • sleep disturbances
Danish: • søvnforstyrrelser
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure
Danish: Samtidig administration af lægemidler, som hæmmer optagelsestransportøren (rifampicin, ciclosporin) eller effluxtransportøren (ritonavir) kan øge den systemiske eksponering for valsartan.
English: • weakness, bruising and frequent infections (aplastic anaemia)
Danish: • svaghedsfølelse, blå mærker og hyppige infektioner (aplastisk anæmi)
English: Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited Wimblehurst Road
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of
Danish: Disse doser hos rotter (200 og 600 mg/kg/dag) er cirka 6 og 18 gange højere end den maksimalt anbefalede humane dosis baseret på mg/m
English: Non-steroidal antiinflammatory medicines (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs
Danish: 2-hæmmere (COX-2hæmmere), acetylsalicylsyre (>3 g/dag) og ikkeselektive NSAID
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Imprida HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Danish: Følgende bivirkninger, som er opstillet efter systemorganklasser i henhold til MedDRA og hyppighed gælder for Imprida HCT (amlodipin/valsartan/hydrochlorthiazid) og amlodipin, valsartan og HCT individuelt.
English: The reductions in systolic/diastolic blood pressure with Imprida HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Danish: Reduktionen i systolisk/diastolisk blodtryk med Imprida HCT var 7,6/5,0 mmHg større end med valsartan/hydrochlorthiazid; 6,2/3,3 mmHg større end med, amlodipin/valsartan og 8,2/5,3 mmHg større end med amlodipin/hydrochlorthiazid.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Danish: Føde nedsætter eksponering af valsartan (målt ved AUC) med ca. 40 % og plasmakoncentrationen (Cmax) med ca. 50 %.
English: fever (erythema multiforme)
Danish: Erythema multiforme
English: Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Danish: Grundet risiko for hyperkaliæmi anbefales det, at samtidig indgift af calciumantagonister, såsom amlodipin, undgås hos patienter mistænkt for eller i behandling for malign
English: In the controlled trial of Imprida HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Danish: De modsat rettede effekter af valsartan 320 mg og hydrochlorthiazid 25 mg på kaliumniveauet i serum balancerede næsten hinanden hos mange patienter i det kontrollerede studie.
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 det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Danish: Antikolinerge midler (fx atropin, biperiden) kan øge biotilgængeligheden af diuretika af thiazidtypen, tilsyneladende ved at reducere den gastrointestinale motilitet og mavetømningshastigheden.
English: The effect of food on hydrochlorothiazide absorption, if any, has little clinical significance.
Danish: Fødeindtagelse har kun minimal, hvis overhovedet nogen klinisk betydning for absorptionen af hydrochlorthiazid.