FrancophonIA/ELRC3.0 huggingface dataset:
English: Take this leaflet and any left-over tablets with you, so the doctor knows what you have taken.
Danish: Tag denne indlægsseddel og resterende tabletter med Dem, så lægen kan se, hvad De har taget.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/ MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLETS/LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Animal studies have shown reduced foetal survival at high doses (see section 5.3).
Danish: Dyrestudier har vist reduceret fosteroverlevelse ved høj dosering (se afsnit 5.3).
English: Postural hypotension and in rare cases syncope may occur at the beginning of therapy, especially at very high doses but also when treatment is recommenced after a break.
Danish: Der kan optræde postural hypotension og i sjældne tilfælde besvimelse i begyndelsen af terapien, navnlig ved meget høj dosering men også når behandlingen genoptages efter en pause.
English: If this happens do not drive or operate machinery.
Danish: Hvis De er døsig, må De ikke køre eller betjene maskiner.
English: Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended.
Danish: Idet der ikke findes nogen klinisk erfaring med patienter med alvorlig leverinsufficiens, anbefales brug hos disse patienter ikke.
English: Doxazosin has shown to be an effective blocker of 1A subtype of alpha-adrenoceptors which make up more than 70% of the adrenergic subtypes in prostate.
Danish: Doxazosin har vist sig effektivt at blokere 1A subtypen af alfa-adrenoceptorer, som udgør mere end 70 % af adrenerge subtyper i prostata.
English: • if you are allergic to doxazosin or to any of the ingredients listed above
Danish: • Hvis De er allergisk for doxazosin eller et af ovennævnte indholdsstoffer
English: • if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs
Danish: • Hvis De ved, at De er overfølsom for quinazolin (fx prazosin, terazosin), som er den kemiske familie med medicin, som doxazosin tilhører
English: There are no adequate data from the use of doxazosin prolonged release tablets in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af doxazosin-depottabletter hos gravide kvinder.
English: Doxazosin is extensively metabolised with <5% excreted as unchanged product.
Danish: Metaboliseringen af doxazosin er omfattende med en ekskretion på <5 % i form af uændret produkt.
English: These medicines work by widening your blood vessels, making it easier for your heart to pump blood through them.
Danish: Denne medicin fungerer ved at udvide blodkarrene, og den gør det derved nemmere for hjertet at pumpe gennem karrene.
English: Pharmacotherapeutic group: Alpha-adrenoceptor antagonists, ATC code: C02CA04
Danish: Farmakoterapeutisk klassifikation: Alfa-adrenoceptor-antagonister, ATC-code: C02CA04
English: • if you suffer from liver problems
Danish: • Hvis De har leverproblemer
English: Common: apathia
Danish: Almindelig: apati
English: • Non-steroidal anti-inflammatory drugs (NSAIDs)
Danish: • Ikke-steroidalt antireumatikum (NSAID)
English: There are no studies concerning interactions with agents influencing hepatic metabolism.
Danish: Der er ingen studier vedrørende interaktionen med midler, der påvirker levermetabolismen.
English: White round biconvex tablets marked “DL” on one side.
Danish: Hvide, runde biconvex-tabletter mærket “DL” på den ene side.
English: Doxazosin is primarily metabolised by O-demethylation and hydroxylation.
Danish: Metaboliseringen af doxazosin sker primært ved O-demetylation og hydroxylation.
English: Studies in pregnant rabbits and rats at daily doses resulting in plasma concentrations 4 and 10 times the human exposure (Cmax and AUC), respectively, revealed no evidence of harm to the foetus.
Danish: Forsøg med drægtige kaniner og rotter med daglige doseringer, som resulterede i plasmakoncentrationer på henholdsvis 4 og 10 gange den humane eksponering (Cmax og AUC), viste ingen tegn på fosterskade.
English: This effect is thought to result from selective blockade of the alpha-1adrenoceptors located in the vasculature.
Danish: Effekten menes at skyldes en selektiv blokering af de alfa-1-adrenoceptorer, der befinder sig i vaskulaturen.
English: Increase in plasma renin activity and tachycardia have rarely been seen during long-term treatment.
Danish: Der er sjældent konstateret forhøjet plasmareninaktivitet og takykardi ved langvarig behandling.
English: Most of the patients with prostatic hyperplasia are controlled with the initial dose.
Danish: Flertallet af patienter med prostatahyperplasi kontrolleres ved en indledende dosering.
English: The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-blockers.
Danish: Det aktive indholdsstof doxazosin i tabletterne tilhører en gruppe af medicin, der kaldes alfa-blokkere.
English: They should be informed about the potential risk for injuries and measures of precaution to minimise orthostatic symptoms.
Danish: Patienterne skal orienteres om den potentielle risiko for læsioner og foranstaltninger med henblik på at minimere ortostatiske symptomer.
English: CHMP was of the opinion that the bioequivalence was sufficiently established after single dose administration in two different bioequivalence studies (study 463/04 and 1995/04-05) and after multiple dose administration (study 5208/02-3) according to the CHMP guidelines.
Danish: CHMP var af den opfattelse, at bioækvivalensen efter indgivelse af en enkelt dosis i to forskellige bioækvivalensundersøgelser (undersøgelse 463/04 og 1995/04-05) og indgivelse af flere doser (undersøgelse 5208/02-3) var blevet tilstrækkeligt påvist i overensstemmelse med CHMP's retningslinjer.
English: Habituation has not been observed during long-term treatment with doxazosin.
Danish: Der er ikke observeret tilvænning ved langvarig behandling med doxazosin.
English: Studies in lactating rats given a single oral dose of radioactive doxazosin gave an accumulation in the breast milk with a maximum concentration of about 20 times greater than the maternal plasma concentration.
Danish: Forsøg med diegivende rotter, som fik en enkelt oral dosering af radioaktivt doxazosin, medførte akkumulering i brystmælken med en maksimal koncentration, som var ca. 20 gange større end moderens plasmakoncentration.
English: This includes any medicines you have bought for yourself, as well as those prescribed for you by a doctor.
Danish: Det gælder både medicin, som De selv har købt og medicin, som De har fået på recept.
English: Patients with acute heart diseases:
Danish: Patienter med akutte hjertesygdomme:
English: Doxazosin is highly bound to plasma proteins (98%).
Danish: Doxazosin bindes i høj grad til plasmaproteiner (98 %).
English: Contact your nearest casualty department or tell your doctor or pharmacist immediately.
Danish: De bør enten kontakte den nærmeste skadestue eller tale med Deres læge eller apotek.
English: • if you suffer from acute heart disease such as pulmonary oedema or heart failure
Danish: • Hvis De lider af akut hjertesygdom såsom lungeødem eller hjertefejl
English: In vitro data in human plasma indicate that doxazosin has no effect on protein binding of digoxin, warfarin, phenytoin or indomethacin.
Danish: In vitro-data i humant plasma viser, at doxazosin ingen effekt har på proteinbindingen af digoxin, warfarin, phenytoin eller indomethacin.
English: Doxazosin has a beneficial effect on blood lipids with significant increase of HDL/total cholesterol ratio (app. 4-13% of base line values), and significant reduction in total glycerides and total cholesterol.
Danish: Doxazosin har en effektiv virkning på blodlipider med signifikant forhøjelse af forholdet mellem HDL/kolesterol (ca. 4-13 % af baseline-værdierne) og en signifikant reduktion af glycerider og kolesterol.
English: 89079 Ulm, Germany Tel: 0049 731 40202
Danish: 89079 Ulm, Tyskland Tlf.: 0049 731 40202
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Danish: De prækliniske sikkerhedsdata viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og karcinogenicitet.
English: Distribution: App. 98% of doxazosin is protein-bound in plasma.
Danish: Distribution: Omtrent 98 % af doxazosinen er proteinbundet i plasma.
English: Non-steroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin.
Danish: Ikke-steroidalt antireumatikum eller estrogener kan reducere doxazosins antihypertensive effekt .
English: The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing
Danish: Plasmaelimineringen er tofaset og elimineringens halveringstid er 22 timer, hvilket danner grundlag for dosering en gang dagligt.
English: Since doxazosin is strongly bound to plasma proteins dialysis is not indicated.
Danish: Idet doxazosin i høj grad er bundet til plasmaproteiner, angives dialyse ikke.
English: Very rare side effects that may occur (in less than 1 in 10,000 people) are: - low white blood cells: low blood platelets, which may result in bruising or easy bleeding
Danish: Meget sjældne bivirkninger (mindre end 1 ud af 10.000 personer): lavt leukocyttal: lavt blodpladetal, som kan medføre suggilation eller nemt ved at bløde
English: The clinical relevance of these findings is still unknown.
Danish: Den kliniske relevans af disse fund er fortsat ukendt.
English: • Dopamine, ephedrine, adrenaline, metaraminol, metoxamine, phenylephrine (medicines used for the treatment of heart problems)
Danish: • Dopamin, efedrin, adrenalin, metaraminol, metoxamin, fenylefrin (medicin, som bruges til behandling af hjerteproblemer)
English: One prolonged-release tablet contains 4,85 mg doxazosin mesilate corresponding to 4 mg doxazosin - The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone, αtocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid - ethyl acrylate co-polymer (1:1), macrogol, and titanium dioxide (E171).
Danish: En depottablet indeholder 4,85 mg doxazosinmesilat svarende til 4 mg doxazosin - De øvrige indholdsstoffer er polyetylenoxid, mikrokrystallisk cellulose, povidon, α-tocopherol, kolloid ren silika, natriumstearylfumarat, methacrylsyre - etylakrylatcopolymer (1:1), macrogol, og titaniumdioxid (E171).
English: With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose.
Danish: Med en dosering en gang dagligt opnås en klinisk signifikant reduktion af blodtrykket hele dagen og 24 timer efter doseringsindgivelsen..
English: In a clinical study in 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase of AUC of 43% and a decrease in oral clearance of app. 40%.
Danish: I et klinisk forsøg med 12 deltagere med moderat leverforringelse resulterede en enkelt dosering af doxazosin i en stigning i AUC på 43 % og et fald i den orale clearance på ca. 40 %.
English: Blood and lymphatic system disorders: Very rare: Reduction of erythrocytes, leucocytes and thrombocytes
Danish: Sygdomme i blod- og lymfesystem: Meget sjælden: Reduktion af erytrocytter, leukocytter og trombocytter
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Nærværende lægemiddel er godkendt i medlemsstaterne i EØS med følgende navne: [Udfyldes ved afslutning af proceduren]
English: If necessary, the dosage may be increased to 8 mg doxazosin once daily.
Danish: Om nødvendigt kan doseringen øges til 8 mg doxazosin en gang dagligt.
English: Elimination:
Danish: Elimering:
English: Pharmacokinetic studies with doxazosin in the elderly have shown no significant alterations compared to younger patients.
Danish: Farmakokinetiske studier med doxazosin hos ældre mennesker har ikke udvist nogen signifikant ændring sammenlignet med yngre patienter.
English: Treatment with doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation as well as enhanced capacity of tissue plasminogen-activator.
Danish: Behandling med doxazosin har vist sig at medføre regression af venstre ventrikulære hypertrofi, ophobning af trombocytter samt forbedret kapacitet af vævsplasminogenaktivator.
English: - The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food with concern regarding the adequate sensitivity of to detect a difference between products,
Danish: - hensigten med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Cardoreg 4mg depottabletter og de tilknyttede navne afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom hypotension og svimmelhed, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995, hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer, og spørgsmålet om, hvorvidt denne afvigelse medfører, at undersøgelserne ikke er tilstrækkeligt følsomme til at kunne registrere forskelle mellem præparaterne,
English: Children and adolescents: Cardoreg 4 mg prolonged release tablets and associated names is not recommended for patients under the age of 18 years.
Danish: Børn og unge: Cardoreg-depottabletter på 4 mg og tilhørende navne anbefales ikke til patienter under 18 år.
English: Like all medicines, Cardoreg 4 mg prolonged release tablets and associated names can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Cardoreg-depottabletter på 4 mg og tilhørende navne have bivirkninger, selvom ikke alle får bivirkninger.
English: Methacrylic acid - ethyl acrylate copolymer (1:1) Dispersion 30 per cent Silica, colloidal anhydrous
Danish: Methacrylsyre - etylakrylatcopolymer (1:1), spredning på 30 % Silika, kolloid ren
English: There are only limited data in patients with liver impairment and on the effects of medicinal products known to influence hepatic metabolism (e.g. cimetidine).
Danish: Der findes kun begrænsede data for patienter med leverskader og for effekten af lægemidler, som vides at påvirke levermetabolismen (fx cimetidin).
English: Pack sizes: 20, 28, 30, 50, 98, 100 and 500 prolonged-release tablets (Normal blister: 20, 30, 50, 100, 500; calendar blister: 28, 98; unit dose blister: 30x1, 50x1, and 100x1)
Danish: Pakningsstørrelser: 20, 28, 30, 50, 98, 100 og 500 depottabletter (normal blister: 20, 30, 50, 100, 500; kalenderblister: 28, 98; enhedsdoseringsblister: 30x1, 50x1 og 100x1) Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: This leaflet was last approved in [To be completed nationally].
Danish: Denne indlægsseddel blev senest godkendt den [udfyldes nationalt].
English: Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats.
Danish: Det blev konstateret, at radioaktiviteten krydsede placenta, efter at mærket doxazosin var givet oralt til drægtige rotter.
English: Do not use Cardoreg 4 mg prolonged release tablets and associated names after the expiry date which is stated on the carton and blister.
Danish: Anvend ikke Cardoreg-depottabletter på 4 mg og tilhørende navne efter udløbsdatoen, som er angivet på karton og blister.
English: Peak plasma levels are approximately one third of those of the same dose of immediate release doxazosin tablets.
Danish: Det maksimale plasmaniveau udgør omtrent en tredjedel i forhold til den samme dosering af doxazosin-tabletter med øjeblikkelig afgivelse.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør tale med Deres læge eller apotek, hvis der er noget, De er i tvivl om..
English: Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Danish: Doxazosin potenserer blodtrykket og reducerer effekten af antihypertensiva.
English: At steady-state, the relative bioavailability of doxazosin from Cardoreg 4 mg prolonged release tablets and associated names compared to immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Danish: Ved steady state udgjorde den relative biotilgængelighed af doxazosin fra Cardoreg-depottabletter på 4 mg og tilhørende navne - sammenlignet med tabletter med øjeblikkelig afgivelse - 54 % ved dosering på 4 mg og 59 % ved dosering på 8 mg.
English: Caution is also recommended when doxazosin is administered concomitantly with medicinal products which may influence hepatic metabolism (e.g. cimetidine).
Danish: Det anbefales at være forsigtig med at give doxazosin samtidigt med lægemidler, som kan påvirke levermetabolismen (fx cimetidin).
English: Cardoreg 4 mg prolonged release tablets and associated names should not be used during pregnancy unless clearly needed.
Danish: Cardoreg-depottabletter på 4 mg og tilhørende navne må ikke bruges ved graviditet, medmindre der er et tydeligt behov herfor.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: These include:
Danish: Den slags medicin omfatter: :
English: If you forget to take Cardoreg 4 mg prolonged release tablets and associated names Try to take your tablets daily as prescribed.
Danish: Hvis De glemmer at tage Cardoreg-depottabletter på 4 mg og tilhørende navne Prøv at tage Deres tabletter dagligt som foreskrevet.
English: The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.
Danish: Bivirkningsprofilen i kliniske forsøg med patienter med benign prostatahyperplasi svarede til den for hypertension.
English: Doxazosin has shown to be free of metabolic adverse effects and is suitable for treatment of patients with coexistent asthma, diabetes, left ventricular dysfunction or gout.
Danish: Doxazosin har vist sig ikke at have metaboliske bivirkninger og er egnet til behandling af patienter med samtidig astma, diabetes, dysfunktion i venstre ventrikel eller gigt.
English: Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4.
Danish: Doxazosinterapi skal udføres med forsigtighed hos patienter med leverskader (se afsnit 4.4.
English: Pharmacokinetic studies with doxazosin in patients with renal impairment also showed no significant alterations compared to patients with normal renal function.
Danish: Farmakokinetiske studier med doxazosin hos patienter med nyreskader viste endvidere ingen signifikant ændring sammenlignet med patienter med normal nyrefunktion.
English: The clinical relevance of these findings is still uncertain.
Danish: Den kliniske relevans af disse fund er fortsat usikker.
English: Silica, colloidal anhydrous Sodium stearyl fumarate
Danish: Silika, colloid ren Natrium stearylfumarat
English: • Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infections or bladder stones
Danish: Benign hyperplasi og samtidig kongestion af de øvre urinveje, kronisk urinvejsinfektion eller blæresten
English: Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin prolonged release tablets to treat benign prostatic hyperplasia (BPH).
Danish: Hypotensive patienter eller patienter med kendt ortostatisk dysregulation, som tager doxazosin-depottabletter, kræver særlig opmærksomhed med henblik på behandling af benign prostatahyperplasi (BPH).
English: • if you have an infection or an obstruction of the urinary tract or bladder stones
Danish: • Hvis De har infektion eller tilstopning af urinvejene eller blæresten
English: The pharmacokinetic properties of doxazosin in Cardoreg 4 mg prolonged release tablets and associated names lead to a minor variation in plasma levels.
Danish: De farmakokinetiske egenskaber for doxazosin i Cardoreg-depottabletter på 4 mg og tilhørende navne indebar en mindre variation i plasmaniveauet.
English: Cardoreg 4 mg prolonged release tablets and associated names can be used as sole agent or in combination with another medicinal product e.g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Danish: Cardoreg-depottabletter på 4 mg og tilhørende navne kan anvendes som det eneste middel eller kombineres med et andet lægemiddel, fx en thiazid-diuretikum, beta-adrenoceptor blokeringsagent, kalciumantagonist eller en ACE-inhibitor.
English: In hypertensive patients with one or more additional risk factors for cardiovascular disease, doxazosin should not be used as a single agent for the first-line treatment of hypertension due to a possible increased risk for development of heart failure.
Danish: Da der kan være forøget risiko for udvikling af hjertefejl, bør doxazosin ikke anvendes som eneste middel som førstevalgsbehandling af hypertension hos hypertensive patienter med en eller flere yderligere risikofaktorer vedrørende kardiovaskulær sygdom.
English: Cardoreg 4 mg prolonged release tablets and associated names has moderate influence on the ability to drive and use machines, especially at the beginning of therapy.
Danish: Cardoreg-depottabletter på 4 mg og tilhørende navne har en moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner, navnlig i begyndelsen af en behandling.
English: Taking other medicines You should always tell your doctor about any medicines you are taking.
Danish: Indtagelse af anden medicin Hvis De tager anden medicin, skal De altid fortælle det til Deres læge.
English: Cardoreg 4 mg prolonged release tablets and associated names are white, round, biconvex tablets with bossing “DL” on one side.
Danish: Cardoreg-depottabletter på 4 mg og tilhørende navne er hvide, runde biconvex-tabletter mærket med “DL” på den ene side.
English: 20 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets 500 prolonged-release tablets
Danish: 20 depottabletter 28 depottabletter 30 depottabletter 50 depottabletter 98 depottabletter 100 depottabletter 500 depottabletter
English: Throughout the recommended dosage range, Cardoreg 4 mg prolonged release tablets and associated names has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
Danish: For hele det anbefalede doseringsområde har Cardoreg-depottabletter på 4 mg og tilhørende navne kun mindre eller ingen effekt på blodtrykket i patienter med normotensiv benign prostatahyperplasi (BPH).
English: The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency.
Danish: Bivirkningerne er anført efter kropssystem, organklasse og absolut frekvens.
English: After oral administration of therapeutic doses, doxazosin in Cardoreg 4 mg prolonged release tablets and associated names is well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing.
Danish: Efter at der gives orale terapeutiske doser, absorberes doxazosin i Cardoreg-depottabletter på 4 mg og tilhørende navne godt med et maksimalt blodniveau, som opnås i løbet af 6 til 8 timer efter doseringen.