FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition the following adverse reactions have been reported for other hydrocortisone medicinal products given for indications other than adrenal insufficiency replacement therapy in higher doses (frequencies not known).
Danish: Endvidere er følgende bivirkninger blevet indberettet for andre hydrocortison-lægemidler, der er givet i højere doser til andre indikationer end substitutionsterapi for binyrebarkinsufficiens (hyppighed ikke kendt).
English: Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing´s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Danish: Langvarig behandling med højere end fysiologiske hydrocortisondoser kan føre til kliniske tilstande, der minder om Cushings syndrom med tiltagen fedme, abdominal fedme, hypertension og diabetes og kan derved resultere i øget risiko for kardiovaskulær morbiditet og mortalitet.
English: Potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole erythromycin, telithromycin, clarithromycin, ritonavir and grapefruit juice can inhibit the metabolism of hydrocortisone, and thus increase blood levels.
Danish: Potente CYP 3A4-hæmmere såsom ketoconazol, itraconazol, posaconazol, voriconazol, erythromycin, telithromycin, chlarithromycin, ritonavir og grapefrugtjuice kan hæmme metabolismen af hydrocortison og derved øge niveauerne i blodet.
English: Plenadren replaces the natural cortisol that is missing in adrenal insufficiency.
Danish: Plenadren erstatter det naturlige cortisol, der mangler hos patienter med binyrebarkinsufficiens.
English: Plenadren comes in bottles with a screw cap containing 50 tablets.
Danish: Plenadren leveres i flasker med et skruelåg indeholdende 50 tabletter;
English: Such effects have not been reported in patients receiving replacement therapy with glucocorticoids in doses used in adrenal insufficiency.
Danish: Sådanne virkninger er ikke indberettet hos patienter, der modtog substitutionsterapi med glukokortikoider i doser, der anvendes ved binyrebarkinsufficiens.
English: Signs include high blood pressure, elevated plasma glucose levels and hypokalaemia.
Danish: Tegn på overdosering omfatter højt blodtryk, forhøjede plasmaglukoseniveauer og hypokaliæmi.
English: Overall, the frequency and type of adverse reactions were similar for Plenadren once daily modifiedrelease tablets and hydrocortisone tablets given three times daily in a 12-week study.
Danish: Overordnet var hyppigheden og typen af bivirkninger næsten ens for Plenadren-tabletter med modificeret udløsning givet én gang daglig og hydrocortison-tabletter givet tre gange daglig i et 12-ugers forsøg.
English: Old age and low body mass index are known risk factors for common adverse reactions of pharmacological doses of glucocorticoids such as osteoporosis, thinning of skin, diabetes mellitus, hypertension and increased susceptibility to infections.
Danish: Fremskreden alder og lav kropsmasseindeks er kendte risikofaktorer for almindelige bivirkninger af farmakologiske doser af glukokortikoider såsom osteoporose, udtynding af huden, diabetes mellitus, hypertension samt en øget modtagelighed over for infektioner.
English: Potent CYP 3A4 inducers such as phenytoin, rifabutin, carbamazepine, barbiturates, rifampicin, St. John's wort and less potent inducers such as the antiretroviral medicinal products efavirenz and nevirapine can enhance the metabolic clearance of cortisol, decrease terminal half-life and thus reduce circulating levels and increase fluctuations of cortisol (due to shorter terminal half-life).
Danish: Potente CYP 3A4-inducere såsom fenytoin, rifabutin, carbamazepin, barbiturater, rifampicin, prikbladet perikum og mindre potente inducere såsom de antiretrovirale lægemidler efavirenz og nevirapin kan forstærke den metaboliske clearance af cortisol, nedsætte den terminale halveringstid og dermed reducere de cirkulerende niveauer og øge variationerne af cortisolniveauerne (på grund af kortere terminal halveringstid).
English: Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate
Danish: Mikrokrystallinsk cellulose Pregelatiniseret stivelse (majs) Kolloid, vandfri silica Magnesiumstearat
English: The modified-release tablet has an outer coating layer that provides an immediate release of the drug and an extended release core.
Danish: Tabletten med modificeret udløsning har en yderbelægning, der giver umiddelbar udløsning af medicinen og en kerne med forlænget udløsning.
English: Cortisol is the principal glucocorticoid secreted by the adrenal cortex.
Danish: Cortisol er det vigtigste glukokortikoid, der dannes i den adrenale cortex.
English: Observed mean serum cortisol concentration versus clock time following single and multiple dosing in primary adrenal insufficiency patients (n=62) after oral administration of Plenadren given once daily and hydrocortisone thrice daily.
Danish: Observeret middel cortisolkoncentration i serum versus tidspunkt efter enkel og multipel dosering hos patienter med primær binyrebarkinsufficiens (n=62) efter oral administration af Plenadren givet én gang daglig og hydrocortison givet tre gange daglig.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate.
Danish: Alle glukokortikoider øger calciumekskretionen og reducerer hastigheden af knogleremodelleringen.
English: Patients suffering from long-term (chronic) adrenal insufficiency need a replacement therapy to survive.
Danish: Patienter, der lider af kronisk binyrebarkinsufficiens, har brug for at få en substitutionsbehandling for at overleve.
English: Plenadren has minor influence on the ability to drive and use machines.
Danish: Plenadren påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: You can breast-feed during Plenadren treatment.
Danish: De kan amme under behandlingen med Plenadren.
English: Untreated and poorly replaced adrenal insufficiency may affect the ability to drive and use machines.
Danish: Ubehandlet eller dårligt substitueret binyrebarkinsufficiens kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • Ketoconazole, itraconazole, posaconazole and voriconazole - used to treat fungal infections
Danish: • Ketoconazol, itraconazol, posaconazol og voriconazol - anvendes til behandling af svampeinfektioner
English: • Ritonavir, efavirenz and nevirapine - used to treat HIV infection
Danish: • Ritonavir, efavirenz og nevirapin - anvendes til behandling af HIV-infektion
English: - if you have short-term or temporary illness such as infections, fever or situations causing a great amount of physical stress, such as surgery: your dose of hydrocortisone must be temporarily increased.
Danish: - hvis De har en kortvarende eller forbigående sygdom såsom infektioner eller feber, eller hvis De oplever situationer, der giver voldsom fysisk stress som for eksempel kirurgi, skal Deres dosis af hydrocortison øges midlertidigt.
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any clinically significant impact on the child.
Danish: Det er næppe sandsynligt, at de hydrocortisondoser, der anvendes i substitutionsterapi, vil have nogen klinisk signifikant indflydelse på barnet.
English: Other medicines and Plenadren
Danish: Brug af anden medicin sammen med Plenadren
English: Talk to your doctor or pharmacist before taking Plenadren - when you have a condition that makes you unable to take this medicine or when the medicine is not absorbed properly from your stomach.
Danish: - hvis De har en tilstand, der gør Dem ude af stand til at tage denne medicin, eller hvis medicinen ikke bliver absorberet rigtigt i maven.
English: In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone.
Danish: Hos patienter med svær leverinsufficiens nedsættes den funktionelle levermasse og hermed evnen til at metabolisere hydrocortison.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: ETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: What Plenadren contains
Danish: Plenadren indeholder:
English: Adrenal crisis can develop in patients with acute adrenal insufficiency.
Danish: Der kan udvikles binyrebarkkrise hos patienter med akut binyrebarkinsufficiens.
English: There is no need for dosage adjustment in patients with mild to moderate renal impairment.
Danish: Det er ikke nødvendigt med dosisjustering hos patienter med mild til moderat nyreinsufficiens.
English: Doses of hydrocortisone used for replacement therapy are unlikely to have any effect on the child.
Danish: Det er usandsynligt, at de doser hydrocortison, der anvendes i substitutionsterapi, vil have nogen virkning på barnet.
English: This medicine may have minor influence on your ability to drive and use machines.
Danish: Lægemidlet kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 modified-release tablets
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 50 tabletter med modificeret udløsning
English: High (supra-physiological) dosages of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Danish: Høje (supra-fysiologiske) doseringer med hydrocortison kan give forhøjet blodtryk, salt- og vandretention og øget kaliumekskretion.
English: Plenadren 20 mg: the tablets are white.
Danish: 20 mg tabletterne er hvide.
English: • Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.
Danish: • Strækmærker, blå mærker, akne-lignende udslæt, voldsom hårvækst i ansigtet, langsom sårheling
English: The cortisol levels in your blood increase rapidly to a maximum level, about 1 hour after taking the tablet in the morning, and then gradually decrease over the day with no or almost no cortisol level in the blood in the late evening and night when the levels should be low.
Danish: Cortisolniveauerne i blodet øges hurtigt til et maksimumniveau omkring en time efter indtagelse af tabletten om morgenen, og derefter falder niveauet gradvis i løbet af dagen.
English: No study has been performed in patients with hepatic impairment, however data in the literature for hydrocortisone support that no dose adjustment is required in mild to moderate hepatic impairment.
Danish: Der er ikke udført studier hos patienter med leverinsufficiens, men data i litteraturen vedrørende hydrocortison understøtter, at der ikke er behov for dosisjustering i forbindelse med mild til moderat leverinsufficiens.
English: Acute adrenal insufficiency
Danish: Akut binyrebarkinsufficiens
English: • Phenytoin, carbamazepine and barbiturates - used to treat epilepsy
Danish: • Fenytoin, carbamazepin og barbiturater - anvendes til behandling af epilepsi
English: On the other hand, the extent of absorption and bioavailability was approximately 30% higher for the 20 mg tablet after food intake compared to fasting and there was no absorption failure or dose dumping.
Danish: 20 mg tabletten efter fødeindtagelse sammenlignet med fastende, og der var ingen absorptionssvigt eller ”dose-dumping”.
English: Increasing the dose of hydrocortisone at one dose occasion increases the total plasma exposure of cortisol less than proportional, see section 5.2.
Danish: Ved øgning af hydrocortisondosis ved ét dosistilfælde øges den totale cortisol-eksponering i plasma mindre end proportionalt, se pkt.
English: In case of age-related low body weight, monitoring of the clinical response is recommended and dose adjustment to a lower dose may be required, see section 5.2.
Danish: I tilfælde af aldersrelateret, lav legemsvægt anbefales det at overvåge den kliniske respons, og det kan være nødvendigt at justere dosis til en lavere dosis, se pkt.
English: Musculoskeletal and connective tissue disorders Osteoporosis with spontaneous fractures.
Danish: Knogler, led, muskler og bindevæv Osteoporose med spontane frakturer.
English: Carton containing 2 bottles of 50 modified-release tablets (100 tablets).
Danish: Karton indeholdende 2 flasker med 50 tabletter med modificeret udløsning (100 tabletter).
English: Plenadren 20 mg modified-release tablets EU/1/11/715/002
Danish: Plenadren 20 mg tabletter med modificeret udløsning EU/1/11/715/002
English: Plenadren 5 mg: the tablets are pink.
Danish: 5 mg tabletterne er lyserøde.
English: During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency.
Danish: Anvendelse i forbindelse med interkurrent sygdom Under interkurrent sygdom skal der udvises særlig opmærksomhed på risikoen for udvikling af akut binyrebarkinsufficiens.
English: What you need to know before you take Plenadren 3.
Danish: Det skal De vide, før De begynder at tage Plenadren Sådan skal De tage Plenadren Bivirkninger
English: How to take Plenadren
Danish: Sådan skal De tage Plenadren
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid Plenadren nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Patients with adrenal insufficiency on long-term glucocorticoid replacement therapy have been found to have reduced bone mineral density.
Danish: Patienter med binyrebarkinsufficiens, som er i langvarig substitutionsbehandling med glukokortikoid, har vist sig at have nedsat knoglemineraltæthed.
English: 50 modified-release tablets 100 modified-release tablets (2x50)
Danish: 100 tabletter med modificeret udløsning (2x50).
English: HDPE bottles with PP screw cap containing 50 modified-release tablets.
Danish: HDPE-flasker med PP-skruelåg indeholdende 50 tabletter med modificeret udløsning.
English: • Erythromycin, telithromycin and clarithromycin - used to treat bacterial infections
Danish: • Erythromycin, telithromycin og chlarithromycin - anvendes til behandling af bakterieinfektioner
English: Skin and subcutaneous tissue disorders Cushing-like symptoms, stria, ecchymoses, acne and hirsutism, impaired wound healing.
Danish: Hud og subkutane væv Cushing-lignende symptomer, striae, ekkymoser, akne og hirsutisme, forringet sårheling.
English: Gastrointestinal disorders Dyspepsia and deterioration of existing gastric ulcer.
Danish: Mave-tarm-kanalen Dyspepsi og forværring af eksisterende mavesår.
English: • Diarrhoea
Danish: • Diaré
English: • The active substance is hydrocortisone.
Danish: Aktivt stof: hydrocortison
English: Therefore, monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Danish: Det anbefales derfor at overvåge den kliniske respons, og dosisjustering kan være nødvendig, se pkt.
English: Use in intercurrent illness
Danish: 4.2 ‘Anvendelse i forbindelse med interkurrent sygdom'.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/001 50 modified-release tablets EU/1/11/715/003 100 (2x50) modified-release tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/715/001 50 tabletter med modificeret udløsning EU/1/11/715/003 100 (2x50) tabletter med modificeret udløsning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/002 50 modified-release tablets EU/1/11/715/006 100 (2x50) modified-release tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/715/002 50 tabletter med modificeret udløsning EU/1/11/715/006 100 (2x50) tabletter med modificeret udløsning
English: • Difficulty sleeping
Danish: • Søvnbesvær
English: During transient illnesses such as low grade infection, fever of any aetiology, stressful situations such as minor surgical procedures, the daily replacement dose must be increased temporarily, see section 4.2, ‘Use in intercurrent illness'.
Danish: I forbindelse med forbigående sygdom såsom low-grade infektion, feber af enhver ætiologi og stressende situationer såsom mindre kirurgiske procedurer skal den daglige substitutionsdosis øges midlertidigt, se pkt.
English: Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white.
Danish: Plenadren 20 mg tabletter med modificeret udløsning Tabletterne er runde (diameter 8 mm), konvekse og hvide.
English: In patients with severe renal impairment monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Danish: Hos patienter med svær nyreinsufficiens anbefales det at overvåge den kliniske respons, og dosisjustering kan være nødvendig, se pkt.
English: Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink.
Danish: Plenadren 5 mg tabletter med modificeret udløsning Tabletterne er runde (diameter 8 mm), konvekse og lyserøde.
English: Pharmacodynamic action
Danish: Farmakodynamisk virkning
English: • The other ingredients are hypromellose, microcrystalline cellulose, pregelatinised starch (maize), colloidal anhydrous silica and magnesium stearate.
Danish: Øvrige indholdsstoffer: hypromellose (E464), mikrokrystallinsk cellulose (E460), pregelatiniseret stivelse (majs), vandfri kolloid silica (E551) og magnesiumstearat.
English: Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three times daily (see section 5.2) clinical response needs to be monitored and further dose individualisation may be required.
Danish: På grund af en lavere biotilgængelighed af den daglige dosis Plenadren sammenlignet med biotilgængeligheden af konventionelle hydrocortisontabletter givet tre gange daglig (se pkt.
English: Plenadren 5 mg: Each modified-release tablet contains 5 mg of hydrocortisone.
Danish: Plenadren 5 mg: Hver tablet med modificeret udløsning indeholder 5 mg hydrocortison.
English: Carton containing 1 bottle of 50 modified-release tablets.
Danish: Karton indeholdende 1 flaske med 50 tabletter med modificeret udløsning.
English: Carton containing one bottle of 50 modified-release tablets.
Danish: Karton indeholdende en flaske med 50 tabletter med modificeret udløsning.
English: Plenadren 20 mg: Each modified-release tablet contains 20 mg of hydrocortisone.
Danish: Plenadren 20 mg: Hver tablet med modificeret udløsning indeholder 20 mg hydrocortison.
English: Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets Hydrocortisone
Danish: Plenadren 5 mg tabletter med modificeret udløsning Plenadren 20 mg tabletter med modificeret udløsning Hydrocortison
English: PHARMACEUTICAL FORM AND CONTENTS Modified-release tablet
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Tablet med modificeret udløsning.
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets
Danish: LÆGEMIDLETS NAVN Plenadren 5 mg tabletter med modificeret udløsning Plenadren 20 mg tabletter med modificeret udløsning
English: Plenadren can be used during breast-feeding.
Danish: Plenadren kan anvendes under amning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Plenadren 20 mg modified-release tablets hydrocortisone
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Plenadren 20 mg tabletter med modificeret udløsning hydrocortison
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Plenadren 5 mg modified-release tablets hydrocortisone
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Plenadren 5 mg tabletter med modificeret udløsning hydrocortison
English: PHARMACEUTICAL FORM Modified-release tablet.
Danish: Tablet med modificeret udløsning.
English: Adverse reactions from these studies and from postmarketing surveillance are listed below by system organ class and frequency as follows:
Danish: Bivirkninger fra disse studier og fra indberetninger efter markedsføringen er opstillet nedenfor efter systemorganklasser og hyppighed på følgende måde: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 5 mg.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet med modificeret udløsning indeholder hydrocortison 5 mg.
English: Plenadren 5 mg modified-release tablets EU/1/11/715/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) Plenadren 5 mg tabletter med modificeret udløsning EU/1/11/715/001
English: Plenadren 5 mg modified-release tablets Tablet coating
Danish: Plenadren 5 mg tabletter med modificeret udløsning Tabletbelægning
English: Plenadren 20 mg modified-release tablets Each modified-release tablet contains hydrocortisone 20 mg.
Danish: Plenadren 20 mg tabletter med modificeret udløsning Hver tablet med modificeret udløsning indeholder 20 mg hydrocortison.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 20 mg.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet med modificeret udløsning indeholder hydrocortison 20 mg.
English: Plenadren 20 mg modified-release tablets Tablet coating
Danish: Plenadren 20 mg tabletter med modificeret udløsning Tabletbelægning
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets hydrocortisone
Danish: LÆGEMIDLETS NAVN Plenadren 5 mg tabletter med modificeret udløsning hydrocortison
English: NAME OF THE MEDICINAL PRODUCT Plenadren 20 mg modified-release tablets hydrocortisone
Danish: LÆGEMIDLETS NAVN Plenadren 20 mg tabletter med modificeret udløsning hydrocortison
English: The patient must be carefully informed how to act in these situations and also advised to immediately seek medical attention should an acute deterioration occur; especially in cases of gastroenteritis, vomiting and/or diarrhoea leading to fluid and salt loss, as well as to inadequate absorption of oral hydrocortisone.
Danish: Dette gælder især i tilfælde af gastroenteritis, opkastning og/eller diaré, der medfører væske- og saltmangel samt utilstrækkelig absorption af oral hydrocortison.
English: If you take more Plenadren than you should
Danish: Hvis De har taget for meget Plenadren
English: Plenadren 5 mg modified-release tablets Each modified-release tablet contains hydrocortisone 5 mg.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Plenadren 5 mg tabletter med modificeret udløsning Hver tablet med modificeret udløsning indeholder 5 mg hydrocortison.
English: Diarrhoea
Danish: Tabletkerne
English: - if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Plenadren Tag ikke Plenadren - hvis De er allergisk over for hydrocortison eller et af de øvrige indholdsstoffer i Plenadren
English: Gastrointestinal disorders
Danish: Skjoldbruskkirtelfunktion
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Danish: Jernoxid rød (E172)
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Plenadren til Dem personligt.
English: Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015
Danish: Dato for første markedsføringstilladelse: 24. august 2005 Dato for seneste fornyelse: 24. april 2015
English: Please read it carefully.
Danish: Læs den omhyggeligt.
English: • rash made worse by sunlight;
Danish: • Udslæt forværret af sollys.
English: As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Danish: Såvel som behandling med FOSAVANCE kan din læge foreslå, at du foretager nogle ændringer i din livsstil, som kan hjælpe dig i din tilstand, for eksempel:
English: • you have been told you have trouble absorbing minerals in your stomach or intestines
Danish: • Du har fået at vide, at du har svært ved at optage mineraler i maven eller tarmen