FrancophonIA/ELRC3.0 huggingface dataset:
English: Common : apathia
Danish: Almindelig: apati
English: You may feel faint or dizzy when standing up from a sitting or lying position especially at the beginning of your treatment or if you restart your treatment after a break.
Danish: De kan muligvis føle Dem svag eller svimmel, når De rejser Dem fra siddende eller liggende stilling, specielt i begyndelsen af behandlingen, eller hvis De starter behandlingen igen efter en pause.
English: BATCH NUMBER
Danish: BATCHNUMMER BN: {tal}
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 gavnlig effekt på blodlipider med signifikant forhøjelse af HDL/total kolesterol-forholdet (ca. 4-13% af udgangsværdier), og signifikant reduktion af totale glycerider og totalt kolesterol.
English: Butylhydroxytoluene (E321) α-Tocopherol
Danish: Butylhydroxytoluen (E321) α-tokoferol
English: Cellulose, microcrystalline Povidone K 29-32
Danish: Mikrokrystallinsk cellulose Povidon K29-32
English: The test product has shown consistent single dose performance across the studies and sufficient reassurance has been provided that the steady state results submitted are representative of other batches.
Danish: Virkningen af en enkelt dosis af testpræparatet var konstant i alle undersøgelserne, og der foreligger tilstrækkelig sikkerhed for, at de fremlagte steady-state-resultater er repræsentative for andre batcher.
English: Very rare (affecting less than one person in 10,000): a reduction in red and white cells in the blood and an increase in urea and creatinine levels in the blood.
Danish: Meget sjælden (rammer under en person ud af 10.000): reduktion i antallet af røde og hvide blodlegemer i blodet og øget mængde urinstof og kreatinin i blodet.
English: Taking other medicines Tell your doctor if you are already taking any of the following as they may interact with your medicine:
Danish: Fortæl det til Deres læge, hvis De allerede bruger nogle af de følgende lægemidler, da disse lægemidler kan påvirke Deres medicin:
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Danish: Prækliniske data viser ingen speciel fare for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagne doser, genotoksicitet og karcinogenitet.
English: Arrowblue Produtos Farndacêuticos S.A., Torre Fernão Magalhães, 10˚ Esq., Av. D. João II - Lisboa, Portugal
Danish: Arrowblue Produtos Farndacêuticos S.A., Torre Fernão Magalhães, 10˚ Esq., Av. D. João II - Lissabon, Portugal
English: Doxazosin should be used with care in patients with Diabetic Autonomic Neuropathy.
Danish: Doxazosin bør anvendes med forsigtighed til patienter med diabetisk autonom neuropati.
English: Doxazosin is primarily metabolised by O-demethylation and hydroxylation.
Danish: Doxazosin metaboliseres primært ved O-demetylering og hydroxylering.
English: Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats
Danish: Det blev konstateret, at radioaktiviteten passerede placenta efter oral administration af mærket doxazosin til drægtige rotter.
English: Habituation has not been observed during long-term treatment with doxazosin.
Danish: Der er ikke observeret tilvænning under langtidsbehandling med doxazosin.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: 9 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN [Udfyldes nationalt]
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: Hos hypertensive patienter med en eller flere yderligere risikofaktorer for kardiovaskulær sygdom bør doxazosin ikke benyttes som enkeltstående lægemiddel ved førstevalgsbehandling af hypertension på grund af mulig øget risiko for udvikling af hjertesvigt.
English: Pack sizes: 28, 30, 56, 98, and 100 prolonged-release tablets
Danish: Pakningsstørrelser: 28, 30, 56, 98 og 100 depottabletter.
English: Very rare : increase of serum creatinine.
Danish: Meget sjælden: forhøjet serumkreatinin
English: The tablets should not be chewed, divided or crushed.
Danish: Kapslerne må ikke tygges, deles eller knuses.
English: Pharmacotherapeutic group: Alpha-adrenoceptor antagonists ATC code: C02CA04
Danish: Farmakoterapeutisk klassifikation: Alfa1-adrenoceptorantagonist, ATC-kode: C02CA04
English: If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint.
Danish: Men undlad at køre bil, betjene maskiner eller udføre aktiviter, som kan være farlige, hvis De bliver svimmel.
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 på diegivende rotter givet i en enkelt oral dosis radioaktivt doxazosin gav en akkumulation i modermælk med en maksimal koncentration på cirka 20 gange over den maternelle plasmakoncentration.
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 ved daglige doser, der medførte plasmakoncentrationer på henholdsvis 4 og 10 gange den humane eksponering (Cmax ogAUC), afslørede ingen tegn på fosterskader.
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: Plasmaeliminationen er tofaset med en endelig halveringstid på 22 timer, og dette er således basis for dosering en gang dagligt
English: Since doxazosin is strongly bound to plasma proteins dialysis is not indicated.
Danish: Da doxazosin er stærkt bundet til plasmaproteiner, er dialyse ikke indiceret.
English: Your medicine is in the form of prolonged-release tablets.
Danish: Deres medicin leveres i form af depottabletter.
English: Patients with acute heart diseases:
Danish: Patienter med akutte hjertelidelser:
English: They are used to treat high blood pressure or the symptoms caused by enlargement of the prostate gland in men.
Danish: De anvendes til behandling af højt blodtryk eller symptomer på forstørret prostatakirtel hos mænd.
English: - It is unlikely that the potential differences observed between the reference product and the generic versions influence the information in the Summary of Product Characteristics (SPC).
Danish: - det ikke er sandsynligt, at de eventuelle observerede forskelle mellem referencepræparatet og den generiske udgave vil påvirke oplysningerne i produktresuméet,
English: Caution is also recommended when doxazosin is administered concomitantly with medicinal products which may influence hepatic metabolism (e.g. cimetidine).
Danish: Forsigtighed anbefales ligeledes, hvis doxazosin administreres samtidigt med lægemidler, der kan påvirke levermetabolismen (f.eks. cimetidine).
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 human plasma indicerer, at doxazosin ikke har nogen indvirkning på proteinbindingen af digoxin, warfarin, fenytoin eller indometacin.
English: Methacrylic acid - ethyl acrylate copolymer (1:1) Dispersion 30 per cent Silica, colloidal anhydrous
Danish: Metakrylsyre - ætylakrylatcopolymer (1:1) Dispersion 30 procent Vandfrit kolloid silica
English: The tablets must be swallowed whole with a sufficient amount of liquid.
Danish: Tabletterne skal sluges hele med tilstrækkelig væske.
English: The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.
Danish: Bivirkningsprofilen ved kliniske forsøg med patienter med benign prostatahyperplasi svarede til det, der ses ved hypertension.
English: The clinical relevance of these findings is still unknown.
Danish: Den kliniske relevans af disse fund er stadig ikke kendt.
English: Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Republic of Ireland.
Danish: Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Irland.
English: Doxazosin is highly bound to plasma proteins (98%).
Danish: Bexaroten er stærkt bundet til plasmaproteiner (98%).
English: In patients with hypertension, the decrease in blood pressure during treatment with doxazosin was similar in both the sitting and standing position.
Danish: Hos patienter med hypertension var blodtrykssænkningen under behandlingen med doxazosin den samme i siddende og stående stilling.
English: Non-steroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin.
Danish: Ikke-steroide antireumatika eller østrogener kan reducere doxazosins antihypertensive effekt.
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 vedrørende patienter med leverinsufficiens og virkningerne af lægemidler, der vides at påvirke levermetabolisme (f.eks. cimetidin).
English: The pharmacokinetic properties of doxazosin lead to a minor variation in plasma levels.
Danish: Doxazosins farmakokinetiske egenskaber medfører en mindre variation i plasmaniveauerne.
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 forsøgspersoner med moderat leverinsufficiens medførte enkeltdosisadministration af doxazosin en forøgelse af AUC på 43% og et fald i oral clearance på ca. 40%.
English: This leaflet was last approved in [To be completed nationally].
Danish: Denne indlægsseddel blev senest godkendt i [udfyldes nationalt].
English: With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose.
Danish: Dosering en gang dagligt giver klinisk signifikant blodtrykssænkning hele dagen igennem og 24-timer efter administration.
English: At steady-state, the relative bioavailability of doxazosin from doxazosin prolonged-release compared to immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Danish: Ved steady-state var den relative biotilgængelighed for doxazosin fra doxazosin-depottablettersammenlignet med direkte virkende doxazosin - 54% ved 4 mg dosen og 59% ved 8 mg dosen.
English: Skin and subcutaneous tissue disorders:
Danish: Sygdomme i hud og subkutane væv:
English: Doxazosin may influence plasma renin activity and urinary excretion of vanillylmandelic acid.
Danish: Doxazosin kan påvirke plasmarenin-aktiviteten og udskillelse i urinen af vanillylmandelsyre.
English: In patients with severe hepatic impairment clinical experience is lacking and therefore the use of doxazosin is not recommended.
Danish: Hos patienter med alvorlig leverinsufficiens savnes klinisk erfaring, hvorfor anvendelse af doxazosin ikke kan anbefales.
English: Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin to treat benign prostatic hyperplasia (BPH).
Danish: Der bør udvises særlig forsigtighed med hypotensive patienter eller patienter med kendt ortostatisk dysregulation, som tager doxazosin for behandling af benign prostatahyperplasia (BPH).
English: Gastrointestinal disorders:
Danish: Gastrointestinale sygdomme:
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: Patients treated with immediate release doxazosin tablets against hypertension can be transferred to doxazosin prolonged-release and the dose titrated upwards as needed, while maintaining effect and tolerability.
Danish: Patienter behandlet med doxazosin-tabletter med umiddelbar frigivelse mod hypertension kan overføres til doxazosin-depottabletter og dosistitreres op efter behov, samtidig med at effekt og toleranc bevares.
English: - The scope of the referral was to agree whether Doxazosin “Arrow” 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 Doxazosin “Arrow” 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: The tablets are white, round and biconvex with the embossing ‘DL'.
Danish: Tabletterne er hvide, runde og bikonvekse med indstemplet ‘DL'.
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 resultere i regression af venstreventrikel-hypertrofi, hæmning af trombocytaggregation samt øget kapacitet af vævsplasminogen-aktivator.
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 til lægen eller apoteket, hvis De tager eller for nylig har taget andre lægemidler.
English: Distribution: App. 98% of doxazosin is protein-bound in plasma.
Danish: Distribution: Cirka 90% af doxazosin er proteinbundet i plasma.
English: - Essential hypertension - Symptomatic treatment of benign prostatic hyperplasia.
Danish: - Essentiel hypertension - Symptombehandling af benign prostatahyperplasi
English: Pharmacokinetic studies with doxazosin in the elderly have shown no significant alterations compared to younger patients.
Danish: Farmakokinetiske forsøg med doxazosin til ældre har ikke vist nogen signifikante forandringer sammenlignet med yngre patienter.
English: Blood and the lymphatic system disorders: Very rare : Reduction of erythrocytes, leucocytes and thrombocytes
Danish: Sygdomme i blod- og lymfesystem: Meget sjælden: Nedsat antal erytrocytter, leukocytter og trombocytter
English: The other ingredients in the tablet coat are methacrylic copolymer, silica colloidal anhydrous, macrogol and titanium dioxide (E-171)).
Danish: De øvrige indholdsstoffer i tabletovertrækket er metakrylcopolymer, vandfrit kolloid silica, makrogol og titaniumdioxid (E-171)).
English: If necessary, the dosage may be increased to 8 mg doxazosin once daily.
Danish: Om nødvendigt kan dosis øges til 8 mg doxazosin en gang dagligt.
English: 10 DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: Throughout the recommended dosage range, doxazosin has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
Danish: Over hele det anbefalede dosisområde har doxazosin kun mindre eller ingen effekt på blodtrykket hos patienter med normotensiv benign prostatahyperplasi (BPH).
English: If you are planning to have surgery and anaesthesia (even at the dentist) you should tell your doctor or dentist that you are taking Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names .
Danish: Hvis De har planlagt et kirurgisk indgreb og narkose (selv hos tandlægen), skal De fortælle lægen eller tandlægen, at De tager Doxazosin Retard Arrow 4 mg depottabletter og tilknyttede navne.
English: Doxazosin is not considered appropriate as first-line treatment, this does not exclude the second- or third-line use in combination with other types of antihypertensives.
Danish: Dette udelukker dog ikke anvendelse som anden eller tredje behandling i kombination med andre typer antihypertensiva.
English: Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Danish: Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, Storbritanninen
English: Doxazosin has a minor or moderate influence on the ability to drive and use machines, especially at the beginning of therapy.
Danish: Doxazosin har mindre eller moderat indflydelse på evnen til at føre bil eller betjene maskiner.
English: Do not chew, crush or divide them.
Danish: Kapslerne må ikke tygges, knuses eller deles.
English: Peak plasma levels are approximately one third of those of the same dose of immediate release doxazosin tablets.
Danish: Peak plasmaniveauer er cirka en tredjedel af værdierne for samme dosis i doxazosin-tabletter med direkte virkning.
English: White, round, biconvex tablets with bossing "DL"
Danish: Hvide, runde, bikonvekse, runde tabletter med indstemplet "DL"
English: Uncommon : arrhythmia, angina pectoris, bradycardia, tachycardia, myocardial infarction
Danish: Ikke almindelig: arytmi, angina pectoris, bradykardi, takykardi, myokardieinfarkt
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 at være fri for metabolske bivirkninger, og det er egnet til behandling af patienter med samtidig astma, diabetes, venstreventrikulær dysfunktion eller gigt.
English: Doxazosin may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Danish: Doxazosin kan anvendes til patienter med benign prostatahyperplasi (BPH), som er enten hypertensive eller normotensive, idet blodtryksforandringerne hos normotensive patienter er klinisk ubetydelige.
English: In patients taking Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names to treat high blood pressure (hypertension), doxazosin works by relaxing the blood vessels so that blood passes through them more easily.
Danish: Hos patienter, der tager Doxazosin Retard Arrow 4 mg depottabletter og tilknyttede navne til behandling af højt blodtryk (hypertension), fungerer doxazosin ved at afslappe blodkarrene, så blodet nemmere kan passere igennem dem.
English: Nervous system disorders:
Danish: Sygdomme i nervesystemet:
English: Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names are available in blister packs of 28, 30, 56, 98 and 100 tablets.
Danish: Doxazosin Retard Arrow 4 mg depottabletter og tilknyttede navne fås i blisterpakninger med 28, 30, 56, 98 og 100 taletter.
English: The clinical relevance of these findings is still uncertain.
Danish: Den kliniske relevans af disse fund er stadig usikker.
English: Patients with hepatic impairment: Doxazosin should be given with particular caution to patients with evidence of impaired liver function.
Danish: Patienter med leverinsufficiens: Doxazosin bør gives med særlig forsigtighed til patienter, der udviser tegn på nedsat leverfunktion.
English: Doxazosin 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: Doxazosin kan benyttes som enkeltstående lægemiddel eller i kombination med andet lægemiddel f.eks. et thiazid-diuretikum, beta-adrenoceptor blokerende middel, calcium-antagonist eller en ACE-hæmmer.
English: Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4.
Danish: Doxazosin-behandling af patienter med leverinsufficiens bør ske med forsigtighed (se afsnit 4.4).
English: Doxazosin should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Danish: Doxazosin bør administreres med forsigtighed til patienter med tegn på let til moderat leverinsufficiens (se afsnit 5.2).
English: Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitation, tachycardia, arrhythmia.
Danish: Hovedpine, svimmelhed, bevidstløshed, synkope, dyspnø, hypotension, palpitation, takykardi, arytmi.
English: Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Danish: Doxazosin potenserer andre antihypertensivas blodtrykssænkende effekt.
English: Pharmacokinetic studies with doxazosin in patients with renal impairment also showed no significant alterations compared to patients with normal renal function.
Danish: Farmakokinetiske forsøg med doxazosin til patienter med nyreinsufficiens viste heller ingen signifikante forandringer sammenlignet med patienter med normal nyrefunktion.
English: After oral administration of therapeutic doses, doxazosin in Doxazosin Retard Arrow 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 oral administration af terapeutiske doser absorberes doxazosin i Doxazosin Retard Arrow 4 mg depottabletter og tilknyttede navne godt med peak blodværdier, der nås gradvist 6 til 8 timer efter dosering.
English: If any of the side effects listed above gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names is not recommended for children and adolescents under the age of 18 years.
Danish: Doxazosin Retard Arrow 4 mg depottabletter og tilknyttede navne kan ikke anbefales til børn og unge under 18 år.
English: Doxazosin should be administered with caution in patients with the following acute heart diseases: Pulmonary oedema as a result of aortic or mitral stenosis, heart failure at high output, right sided heart failure as a result of pulmonary embolism or pericardiac effusion and left sided ventricular heart insufficiency with low filling pressure.
Danish: Doxazosin bør indgives med forsigtighed til patienter med følgende akutte hjertesygdomme: Pulmonalt ødem som følge af aortaklap- eller mitralklapstenose, hjertesvigt ved høj effekt, højresidet hjertesvigt som følge af lungeemboli eller perikardiel effusion og venstresidet ventrikulær hjerteinsufficiens med lavt fyldningstryk.
English: This is common in patients with enlargement of the prostate gland.
Danish: Dette er almindeligt hos patienter med forstørret prostatakirtel.