FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Hvis en bivirkning bliver alvortlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt I denne indlægsseddel, bør De fortælle det til Deres læge.
English: Methacrylic acid - ethyl acrylate copolymer (1:1) Dispersion 30 per cent Silica, colloidal anhydrous
Danish: Methacrylsyre - ethylakrylat copolymer (1:1) Dispersion 30 procent Kolloidalt vandfrit silica
English: Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended.
Danish: Da der ikke findes klinisk erfaring fra patienter med svær leverinsufficiens, anbefales anvendelse til disse patienter ikke.
English: They are available in PVC/PVDC/aluminium blisters packs of 28 tablets [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) tablets and in HDPE tablet containers of 100, 250 tablets].
Danish: De findes i PVC/PVDC/aluminium blisterpakninger, der indeholder 28 tabletter [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tabletter og i HDPE tabletbeholdere med 100, 250 tabletter.
English: Blood and lymphatic system disorders: Very rare: Reduction of erythrocytes, leucocytes and thrombocytes
Danish: Sygdomme i blod- og lymfesystem: Meget sjælden: Reduktion i erythrocytter, leukocytter og thrombocytter
English: Butylhydroxytoluene (E321) α-Tocopherol
Danish: Butylhydroxytoluen (E321) α-Tocopherol
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 er kun begrænsede data vedrørende patienter med nedsat leverfunktion og om virkningerne af lægemidler, der vides at have indflydelse på levermetabolismen (f.eks. cimetidin).
English: • if you have or have had a blockage in your gut
Danish: • hvis De har eller har haft nogen form for obstruktion af fordøjelseskanalen
English: PVC/PVDC/aluminium blisters
Danish: Blister (PVC/PVDC/aluminium)
English: • painkillers called non-steroidal anti-inflammatory medicine (NSAIDs) eg.
Danish: • Smertestillende midler, der kaldes non-steroide inti-inflammatoriske midler (NSAID'er), f.eks. Ibuprofen
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 en klinisk undersøgelse af 12 forsøgspersoner med moderat nedsat leverfunktion resulterede en administration af en enkeltdosis doxazosin i en øgning af AUC på 43% og et fald i oral clearance på cirka 40%.
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 venstre ventrikulær hypertrofi, hæmning af thrombocytophobning såvel som forbedret kapacitet af vævsplasminogen-aktivator.
English: LIST OF EXCIPIENTS Contains butylhydroxytoluene (E321) PHARMACEUTICAL FORM AND CONTENTS 100 prolonged-release tablets 250 prolonged-release tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use The tablets should be swallowed whole.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder butylhydroxytoluen (E321) LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 depottabletter 250 depottabletter ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral anvendelse Tabletter skalæ sluges hele.
English: HDPE tablet container
Danish: HDPE tabletbeholder
English: Sympathomimetics may reduce the antihypertensive effect of doxazosin; doxazosin may reduce blood pressure and vascular reactions to dopamine, ephedrine, epinephrine, metaraminol, methoxamine and phenylephrine.
Danish: Sympatomimetika kan nedsætte den antihypertensive virkning af doxazosin; doxazosin kan nedsætte blodtrykket og vaskulære reaktioner for dopamin, efedrin, epinefrin, metaraminol, methoxamin og fenylefrin.
English: Like all medicines, Doxagamma 4 mg prolonged release tablets and associated names can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Doxagamma 4 mg depottabletter og dermed forbundne navne have bivirkninger, selvom ikke alle får bivirkninger.
English: • if you have liver problems
Danish: • hvis De har problemer med leveren
English: Contains butylhydroxytoluene (E321)
Danish: Indeholder butylhydroxytoluen (E321)
English: Caution is also recommended when doxazosin is administered concomitantly with medicinal products, which may influence hepatic metabolism (e.g. cimetidine).
Danish: Der anbefales også forsigtighed, når doxazosin gives somtidig med lægemidler, der kan øve indflydelse på levermetabolismen (f.eks. cimetidin).
English: - The scope of the referral was to agree whether Doxagamma 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 Doxagamma 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: At steady-state, the relative bioavailability of doxazosin from Doxagamma 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 var den relative biotilgængelighed for doxazosin fra Doxagamma 4 mg depottabletter og dermed forbundne navne sammenlignet med den umiddelbare frigivelsesform 54% ved 4 mg dosis og 59% ved 8 mg dosis.
English: • if you need a blood test as Doxagamma 4 mg prolonged release tablets and associated names can affect some test results.
Danish: • Hvis De skal have taget en blodprøve, da Doxagamma 4 mg depottabletter og dermed forbundne navne kan påvirke visse testresultater
English: Doxazosin may influence plasma renin activity and urinary excretion of vanillylmandelic acid.
Danish: Doxazosin kan øve inflydelse på plasma reningaktivitet og udskillelse i urinen af vaniljemandelsyre.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING HDPE TABLET CONTAINER
Danish: MINDSTEKRAV TIL DEN UMIDDELBARE EMBALLAGE HDPE TABLET BEHOLDER
English: Your ‘modified release' tablets have been specially designed to slowly release the medicine from the tablet shell.
Danish: Deres tabletter med 'modificeret frigivelse' er specielt udformet til langsom frigivelse af lægemidlet fra tabletskallen, Skallen nedbrydes ikke, men passerer igennem kroppen.
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 metaboliske bivirkninger og er passende for behandling af patienter med samtidig eksisterende astma, diabetes, venstre ventrikulær fejlfunktion eller podagra
English: After oral administration of therapeutic doses, doxazosin in Doxagamma 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, bliver doxazosin i Doxagamma 4 mg depottabletter og dermed forbundne navne godt absorberet med peak blodniveauer gradvis nået ved 6 til 8 timer efter dosering.
English: Pharmacokinetic studies with doxazosin in the elderly have shown no significant alterations compared to younger patients.
Danish: Farmakokinetiske undersøgelser med doxazosin depottabletter hos ældre har vist, at der ikke er signifikante ændringer sammenlignet med yngre patienter.
English: Peak plasma levels are approximately one third of those of the same dose of immediate release doxazosin tablets.
Danish: Peak plasmaniveauer er omkring en tredjedel af niveauet opnået efter administration af doxazosin tabletter med umiddelbar frigivelse.
English: If you stop taking Doxagamma 4 mg prolonged release tablets and associated names Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure.
Danish: Hvis De holder op med at tage Doxagamma 4 mg depottabletter og dermed forbundne navne Lad være med pludselig at holde op med at tage Deres medicin, da det kan medføre alvorlige ændringer i Deres blodtryk.
English: Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) tablets Calendar packs of 28 and 98
Danish: Æsker med 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tabletter Kalenderpakninger med 28 og 98 depottabletter Enhedsdoseringspakning med 50 x 1
English: UK Tel: 00 44 1707 853000
Danish: Det Forenede Kongerige Tlf.: 00 44 1707 853000
English: This leaflet was last approved in [To be completed nationally].
Danish: Denne indlægsseddel blev senest godkendt den [Udfyldes national].
English: - The other ingredients are macrogol, microcrystalline cellulose, povidone, butylhydroxytoluene
Danish: - De øvrige indholdsstoffer er makrogol, mikrokrystallinsk cellulose, povidon,
English: UK Tel: 00 44 1707 853000 Fax: 00 44 1707 650734
Danish: Det Forenede Kongerige Tlf.: 00 44 1707 853000 Fax: 00 44 1707 650734
English: ASSOCIATED NAMES
Danish: DERMED FORBUNDNE NAVNE:
English: • medicine containing Dopamine, Metaraminol, Methoxamine, Adrenaline (Epinephrine) cough and cold remedies as they may contain Ephedrine, Phenylephrine.
Danish: • Medicin, der indeholder dopamin, metaraminol, methoxamin, adrenalin (epinefrin), hoste- og forkølelsesmidler, der kan indeholde efedrin, fenylefrin
English: Pharmacokinetic studies with doxazosin in patients with renal impairment also showed no significant alterations compared to patients with normal renal function.
Danish: Farmakokinetiske undersøgelser med doxazosin hos patienter med nedsat nyrefunktion viste heller ikke nogen signifikante ændringer sammenlignet med patienter med normal nyrefunktion.
English: Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitation, tachycardia, arrhythmia.
Danish: Hovedpine, svimmelhed, bevidstløshed, synkope, dyspnøe, hypotension, palpitationer, takykardi, arytmi.
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 gives med forsigtighed til patienter med følgende akutte hjertesygdomme: Lungeødem som et resultat af aorta- eller mitralstenose, hjertesvigt ved højt output, højresidig hjertesvigt som et resultat af lungeemboli, perikardial effusion og venstresidig ventrikulær hjerteinsufficiens med lavt fyldningstryk.
English: If necessary, the dosage may be increased to 8 mg doxazosin once daily.
Danish: Om nødvendigt kan dosis øges til 8 mg doxazosin én gang daglig.
English: Alternatively, breastfeeding must be stopped, if treatment with Doxagamma 4 mg prolonged release tablets and associated names is unavoidable.
Danish: Alternativt skal amning stoppes, hvis behandling med Doxagamma 4 mg depottabletter og dermed forbundne navne er uundgåelig.
English: The usual starting dose is one Doxagamma 4 mg prolonged release tablets and associated names tablet once a day.
Danish: Den sædvanlige startdosis er én Doxagamma 4 mg depottabletter og dermed forbundne navne tablet én gang daglig.
English: Doxagamma 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: Doxagamma 4 mg depottabletter og dermed forbundne navne har moderat indflydelse på evnen til at køre bi log betjene maskiner, især i begyndelsen af behandlingen.
English: The majority of the adverse reactions were transient The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.
Danish: Bivirkningsprofilen i kliniske afprøvninger hos patienter med benign prostatahyperplasi svarede til den, der ses ved hypertension.
English: Symptomatic treatment of prostatic hyperplasia:
Danish: Symptomatisk behandling af prostatahyperplasi:
English: Patients with renal impairment: Since there is no change in pharmacokinetics in patients with impaired renal function, and since there are no signs that doxazosin aggravates existing renal impairment, the usual dose can be used in these patients.
Danish: Da der ikke er nogen ændring i farmakokinetikken hos patienter med nedsat nyrefunktion, og da der ikke er nogen tegn på, at doxazosin forværrer eksisterende nedsat nyrefunktion, kan normal dosering generelt anvendes til disse patienter.
English: Patients treated with immediate release doxazosin tablets against hypertension can be transferred to Doxagamma 4 mg prolonged release tablets and associated names 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 Doxagamma 4 mg depottabletter og dermed forbundne navne, og dosis titreret opad efter behov, mens virkning og tolerans bibeholdes
English: The occurrence of adverse reactions are mainly due to the pharmacological properties of the medicinal product.
Danish: Forekomsten af bivirkninger skyldes hovedsagelig lægemidlets farmakologiske egenskaber, og hovedparten af bivirkningerne var forbigående.
English: White, round, biconvex tablets with bossing “DL”
Danish: Hvide, runde bikonvekse tabletter med påtrykt “DL” på den ene side.
English: Doxazosin has been administered together with thiazide diuretics, furosemide, beta-blocking agents, antibiotics, oral hypoglycaemic agents, uricosuric agents, or anticoagulants without adverse drug interactions.
Danish: Doxazosin er blevet administreret sammen med thiaziddiuretika, furosemid, beta-blokerende midler, antibiotika, orale hypoglykæmiske midler, urikosuriske midler eller antikoagulantia uden bivirkningersreaktioner.
English: To treat hypertension, your doctor may give you another medicine to take along with Doxagamma 4 mg prolonged release tablets and associated names .
Danish: Til behandling af hypertension kan Deres læge give Dem anden medicin, der skal tages sammen med Doxagamma 4 mg depottabletter og dermed forbundne navne.
English: Doxagamma 4 mg prolonged release tablets and associated names should not be used during pregnancy unless clearly needed.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne bør ikke anvendes under graviditet, medmindre der er et klart behov.
English: If you forget to take Doxagamma 4 mg prolonged release tablets and associated names Take it as soon as you remember.
Danish: Hvis De glemmer at tage Doxagamma 4 mg depottabletter og dermed forbundne navne Tag den, så snart De kommer i tanke om den.
English: Doxagamma 4 mg prolonged release tablets and associated names can also be given to men suffering from an enlarged prostate gland, as it can relax the muscles allowing urine to be passed more easily.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne kan også gives til mænd, der lider af en forstørret prostatakirtel, da det kan afslappe musklerne og dermed tillade urinen at passerer lettere
English: Doxagamma 4 mg prolonged release tablets and associated names can treat high blood pressure (hypertension) by relaxing the blood vessels in the body and lowering blood pressure.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne kan behandle forhøjet blodtryk (hypertension) ved at afslappe blodkarrene i kroppen og sænke blodtrykket.
English: The pharmacokinetic properties of doxazosin in Doxagamma 4 mg prolonged release tablets and associated names lead to a minor variation in plasma levels.
Danish: De farmakokinetiske egenskaber ved doxazosin i Doxagamma 4 mg depottabletter og dermed forbundne navne leder til en mindre variation i plasmaniveauer.
English: Uncommon: nightmares, amnesia, emotional instability Rare: depression, agitation
Danish: Usædvanlig: Mareridt, hukommelsestab, følelsesmæssig ustabilitet Sjælden: Depression, agitation
English: Doxagamma 4 mg prolonged release tablets and associated names tablets are white, round, biconvex tablets with bossing “DL”.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne tabletter er hvide, runde, bikonvekse tabletter med “DL” påtrykt.
English: Ear and labyrinth disorders: Uncommon: tinnitus
Danish: Sygdomme i det ydre og indre øre: Usædvanlig: Tinnitus
English: Administration of Doxagamma 4 mg prolonged release tablets and associated names to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Danish: Administration af Doxagamma 4 mg depottabletter og dermed forbundne navne til patienter med prostatahyperplasi resulterer i en signifikant forbedring af urodynamikken og symptomer som et resultat af en selektiv blokade af alfa-adrenoreceptorer lokaliseret prostatas muskelstroma, kapsel og hals.
English: Doxagamma 4 mg prolonged release tablets and associated names is unlikely to affect your blood pressure unless you suffer from hypertension.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne vil sandsynligvis ikke påvirke Deres blodtryk, medmindre De lider af hypertension.
English: Peak/trough ratio of Doxagamma 4 mg prolonged release tablets and associated names is less than half that of immediate release doxazosin tablets.
Danish: Peak/bølgedalsratio for Doxagamma 4 mg depottabletter og dermed forbundne navne er mindre end halvdelen af den for doxazosin tabletter med umiddelbar frigivelse.
English: Throughout the recommended dosage range, Doxagamma 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: Henover det anbefalede doseringsområde har Doxagamma 4 mg depottabletterne og dermed forbundne navne kun lille eller ingen virkning på blodtrykket hos normotensive patienter med benign prostatahyperplasi (BPH).
English: 10 prolonged-release tablets 20 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 56 prolonged-release tablets 60 prolonged-release tablets 90 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets 140 prolonged-release tablets
Danish: 10 depottabletter 20 depottabletter 28 depottabletter 30 depottabletter 50 depottabletter 56 depottabletter 60 depottabletter 90 depottabletter 98 depottabletter 100 depottabletter 140 depottabletter
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én depottablet indeholder 4 mg doxazosin (som mesilat).
English: Adults: Usually 4 mg doxazosin once daily.
Danish: Sædvanligvis 4 mg doxazosin én gang daglig.
English: Doxagamma 4 mg prolonged release tablets and associated names 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: Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes til ved benign prostatahyperplasi (BPH) patienter, der er enten hypertensive eller normotensive, da ændringer i blodtrykket hos normotensive patienter er klinisk usignifikant.
English: Respiratory, thoracic and mediastinal disorders: Common: dyspnoea, rhinitis
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum: Almindelig: Dyspnøe, rhinit
English: Children and adolescents: Doxagamma 4 mg prolonged release tablets and associated names are not recommended for patients under the age of 18 years.
Danish: Doxagamma 4 mg depottabletter og dermed forbundne navne anbefales ikke til patienter under 18 år gamle.
English: Doxagamma 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: Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes som monoterapi eller i kombination med andre lægemidler, f.eks. et thiaziddiuretikum, et beta-adrenoreceptorblokerende middel, en calciumantagonist eller en ACE-hæmmer.
English: Uncommon: arrhythmia, angina pectoris, bradycardia, tachycardia, myocardial infarction
Danish: Almindelig: Palpitationer, brystsmerter Usædvanlig: Arytmi, angina pectoris, bradykardi, takykardi, myokardieinfarkt
English: Administration of Doxagamma 4 mg prolonged release tablets and associated names in hypertensive patients causes a clinically significant reduction in blood pressure as a result of a reduction in systemic vascular resistance.
Danish: Administration af Doxagamma 4 mg depottabletter og dermed forbundne navne hos hypertensive patienter medfører en klinisk signifikant reduktion af blodtrykket som et resultat af en reduktion i den systemiske vaskulære modstand.
English: - Essential hypertension - Symptomatic treatment of benign prostatic hyperplasia.
Danish: Symptomatisk behandling af benign prostatahyperplasi.
English: 5 HOW TO STORE DOXAGAMMA 4 MG PROLONGED RELEASE TABLETS AND
Danish: 5 HVORDAN DE OPBEVARER DOXAGAMMA 4 MG DEPOTTABLETTER OG
English: Doxazosin should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Danish: Doxazosin bør gives med forsigtighed til patienter med tegn på lettere til moderat nedsat leverfunktion (se pkt.
English: Uncommon: alopecia, oedema of the face/general oedema Rare: rash, pruritus, purpura
Danish: Usædvanlig: Alopecia, ødem i ansigtet/generelt ødem Sjælden: Udslæt, pruritus, purpura
English: What Doxagamma 4 mg prolonged release tablets and associated names contains - The active substance is 4 mg of doxazosin as doxazosin mesilate.
Danish: Hvad Doxagamma 4 mg depottabletter og dermed forbundne navne indeholder - Det aktive stof er 4 mg doxazosin som doxazosinmesilat).
English: Doxazosin is extensively metabolised with <5% excreted as unchanged product.
Danish: Doxazosin bliver omfattende metaboliseret med <5% udskilt som uændret produkt Doxazosin bliver primært metaboliseret ved O-demethylering og hydroxylering.
English: Common: muscle cramps, fatigue, malaise, headache, somnolence Uncommon: tremor, muscular stiffness Rare: paraesthesia
Danish: Almindelig: Muskelkramper, træthed, malaise, hovedpine, somnolens Usædvanlig: Tremor, muskelstivhed Sjælden: Paræstesi
English: Each prolonged-release tablet contains 4 mg of doxazosin (as mesylate).
Danish: Hver depottablet indeholder 4 mg doxazosin (som mesilat).
English: Do not take Doxagamma 4 mg prolonged release tablets and associated names if you are pregnant or breast-feeding.
Danish: De må ikke tage Doxagamma 4 mg depottabletter og dermed forbundne navne, hvis De er gravid eller ammer.