FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with adrenal insufficiency and concomitant retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
Danish: Patienter med binyrebarkinsufficiens og samtidig retroviral infektion, såsom HIV, har behov for omhyggelig dosisjustering på grund af potentiel interaktion med antiretrovirale lægemidler og forhøjet hydrocortisondosis på grund af infektionen.
English: Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention.
Danish: Derfor skal patienter oplyses om tegn og symptomer på akut binyrebarkinsufficiens og binyrebarkkrise samt behovet for at søge øjeblikkelig lægehjælp.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow the tablets whole.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Synk tabletterne hele.
English: There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder.
Danish: Der foreligger ingen data vedrørende patienter med bekræftet langsom gastrisk tømning eller sygdom/lidelser med nedsat motilitet.
English: Glucocorticoids are important steroids for intermediary metabolism, immune function, musculoskeletal and connective tissue and the brain.
Danish: Glukokortikoider er vigtige steroider til intermediær metabolisme, immunfunktion, muskuloskeletalt væv og bindevæv samt hjernen.
English: The adverse reaction profile in the treatment of adrenal insufficiency is therefore not comparable to that in other conditions requiring much higher doses of oral or parenteral glucocorticoids.
Danish: Bivirkningsprofilen i behandlingen af binyrebarkinsufficiens er derfor ikke sammenlignelig med profilen ved andre tilstande, der kræver meget højere doser oral eller parenteral glukokortikoider.
English: • Salt and water retention causing swelling and raised blood pressure (shown on medical examination) and low potassium level in the blood
Danish: • Salt- og vandophobning i kroppen, der medfører hævelse og forhøjet blodtryk (påvist ved lægeundersøgelse) samt lavt kaliumniveau i blodet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Contact your doctor promptly for advice if you notice any of these.
Danish: Rådfør Dem straks med lægen, hvis De bemærker nogle af disse ting.
English: During adrenal crisis parenteral, preferably intravenous administration of hydrocortisone in high doses, together with sodium chloride 9 mg/ml (0.9%) solution for infusion, should be administered according to current treatment guidelines.
Danish: Under binyrebarkkrise skal der gives parenteral, helst intravenøs administration af hydrocortison i høje doser sammen med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning, i henhold til gældende retningslinjer for behandling.
English: Endocrine disorders Induction of glucose intolerance or diabetes mellitus.
Danish: Det endokrine system Fremprovokering af glukoseintolerans eller diabetes mellitus.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Plenadren på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids.
Danish: Farmakoterapeutisk klassifikation: Kortikosteroider til systemisk brug, glukokortikoider.
English: Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced.
Danish: Frugtbarheden hos kvinder med binyreinsufficiens eller cortisolmangel kan være nedsat.
English: • When you wake up in the morning swallow Plenadren tablets whole with a glass of water at least 30 minutes before your breakfast, preferable between 6.00 am and 8.00 am in the morning.
Danish: • Når De vågner om morgenen, skal De synke Plenadren-tabletten (tabletterne) hele sammen med et glas vand mindst 30 minutter, inden De spiser morgenmad; helst mellem kl. 06 og 08 om morgenen.
English: • Heartburn, aggravation of any existing stomach ulcer
Danish: • Halsbrand, forværring af eventuelt eksisterende mavesår
English: The following signs and symptoms may suggest that you need to take additional doses of Plenadren or other forms of hydrocortisone: fatigue, weight loss, stomach discomfort, feeling light headed when you change from sitting to standing or dizziness when standing, darkening of your skin particularly skin creases and exposed areas.
Danish: De følgende tegn og symptomer kan tyde på, at De har behov for at tage ekstra doser af Plenadren eller andre former for hydrocortison: træthed, vægttab, mavebesvær, følelse af at være omtåget, når De rejser Dem op fra siddende stilling, eller svimmelhed, når De står op, mørkere hud, især i hudfolder og udsatte områder.
English: The exposure increased three-fold when the dose of hydrocortisone modified-release increased from 5 mg to 20 mg.
Danish: Eksponeringen tredobledes, når dosen af hydrocortison med modificeret udløsning steg fra 5 mg til 20 mg.
English: However, these adverse reactions (abdominal pain, diarrhoea, nausea and fatigue) are mild or moderate, transient, of short duration but may require dose adjustment or additional concomitant medicinal products, see section 4.2.
Danish: Imidlertid er disse bivirkninger (abdominal smerte, diaré, kvalme og træthed) milde eller moderate, forbigående, af kort varighed, men kan kræve dosisjustering eller yderligere samtidige lægemidler, se pkt.
English: During long term treatment with medicines treating infections (antibiotics) the dose of Plenadren may need adjustment by your doctor.
Danish: Under langvarig behandling med lægemidler mod infektioner (antibiotika) vil det muligvis være nødvendigt, at Deres læge justerer Deres Plenadren-dosis.
English: Hydrocortisone (cortisol) is a lipophilic drug that is eliminated completely via metabolism with a low clearance and accordingly low intestinal and hepatic extraction ratios.
Danish: Hydrocortison (cortisol) er et lipofilt lægemiddel, der elimineres fuldstændigt via metabolisme med en lav clearance og tilsvarende lav intestinal og hepatisk ekstraktionsratio.
English: • Raised pressure in the eye (glaucoma), clouding of the lens in the eye (cataract)
Danish: • Forhøjet tryk i øjet (glaukom), øjets linse bliver sløret (katarakt)
English: There was an initial increase in the frequency of adverse reactions in about one in five patients, observed up to eight weeks after first changing from conventional hydrocortisone tablets given three times daily to once daily modified-release tablets.
Danish: Der var en initial stigning i hyppigheden af bivirkninger hos cirka én ud af fem patienter, observeret i op til otte uger efter de først havde skiftet fra konventionelle hydrocortisontabletter givet tre gange daglig til tabletter med modificeret udløsning givet én gang daglig.
English: These tablets deliver hydrocortisone to your body throughout the day.
Danish: Disse tabletter frigiver hydrocortison til kroppen hele dagen igennem.
English: MedDRA System Organ Class
Danish: MedDRAs systemorganklasse
English: Modified-release tablets are not recommended in patients with increased gastrointestinal motility, i.e., chronic diarrhoea, due to the risk of impaired cortisol exposure.
Danish: Tabletter med modificeret udløsning frarådes til patienter med øget gastrointestinal motilitet, dvs. kronisk diaré, på grund af risikoen for nedsat cortisol-eksponering.
English: In these situations you should seek immediate medical care in order to receive treatment with injections of hydrocortisone and extra fluid administration.
Danish: I sådanne situationer bør De omgående søge lægehjælp, så De kan få behandling med injektioner af hydrocortison samt få tilført ekstra væske.
English: In addition, tell your doctor or pharmacist if you are using any of the following medicines, as the dose of Plenadren may need to be changed:
Danish: De bør endvidere fortælle det til lægen eller apotekspersonalet, hvis De bruger et eller flere af følgende lægemidler, da det i så fald måske vil være nødvendigt at justere Deres Plenadren-dosis:
English: It is therefore important to take this medicine as directed by your doctor when driving or using machines.
Danish: Det er derfor vigtigt, at De tager denne medicin nøjagtigt efter lægens anvisning, hvis De skal føre motorkøretøj eller betjene maskiner.
English: Moreover, there is no reason to believe that doses of hydrocortisone used for replacement therapy in adrenal insufficiency may reduce the response to vaccines and increase the risk of generalised infection with live vaccines.
Danish: Der er desuden ingen grund til at tro, at hydrocortisondoser, som anvendes som substitutionsbehandling hos patienter med binyrebarkinsufficiens, vil reducere responsen til vacciner og øge risikoen for generaliseret infektion med levende vacciner.
English: • Do not divide, crush or chew the tablets.
Danish: • De må ikke dele, knuse eller tygge tabletterne.
English: • Mood changes such as feelings of overexcitement or losing touch with reality
Danish: • Humørsvingninger såsom en fornemmelse af voldsom ophidselse eller mistet jordforbindelse
English: The bioavailability (AUC0-24h) is 20% lower with the modified-release tablet compared to the same daily dose of hydrocortisone given as conventional tablets three times daily.
Danish: Biotilgængeligheden (AUC0-24h) er 20 % lavere for tabletten med modificeret udløsning sammenlignet med den samme daglige dosis hydrocortison givet som konventionelle tabletter tre gange daglig.
English: Fatigue and episodes of short-lasting vertigo have been reported.
Danish: Træthed og episoder med kortvarende vertigo er indberettet.
English: During short-term or temporary illnesses such as infection, fever, or physical stress such as surgery you will need more hydrocortisone since the body cannot produce the additional amount of cortisol required in these situations.
Danish: Under kortvarig eller forbigående sygdom såsom infektion, feber eller fysisk stress som for eksempel kirurgi, vil De have brug for mere hydrocortison, da kroppen ikke kan producere den ekstra mængde cortisol, der kræves i sådanne situationer.
English: Patients with adrenal insufficiency should be monitored for thyroid dysfunction as both hypothyroidism and hyperthyroidism may markedly influence the exposure of administered hydrocortisone.
Danish: Patienter med binyrebarkinsufficiens bør overvåges vedrørende skjoldbruskkirtelfunktion, da både hypothyroidisme og hyperthyroidisme kan have markant indflydelse på eksponeringen af det administrerede hydrocortison.
English: Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported.
Danish: Voldsom træthed og episoder med kortvarig svimmelhed (vertigo) er indberettet.
English: Hydrocortisone interactions listed below have been reported after therapeutic doses of glucocorticoids.
Danish: De nedenfor nævnte hydrocortison-interaktioner er indberettet efter terapeutiske doser af glukokortikoider.
English: When the oral dose is increased the total plasma exposure of cortisol increased less than proportional.
Danish: Når den orale dosis øges, øges cortisols totale eksponering i plasma mindre end proportionalt.
English: The coating system is a mixture of macrogol (3350), polyvinyl alcohol, talc and titanium oxide (E171).
Danish: Belægningen er en blanding af makrogol (3350), polyvinylalkohol, talkum (E553b) og titaniumoxid (E171).
English: Patients with adrenal insufficiency have been shown to have reduced parity, which is most likely due to the underlying disease, but there is no indication that hydrocortisone in doses for replacement therapy will affect fertility.
Danish: Patienter med binyrebarkinsufficiens har vist sig at have reduceret paritet, hvilket sandsynligvis skyldes den underliggende sygdom, men der er intet, der tyder på, at hydrocortison i doser, der anvendes i substitutionsbehandling, vil påvirke fertiliteten.
English: Upper abdominal pain Nausea
Danish: Smerte i øvre abdomen Kvalme
English: Acute adrenal insufficiency may develop in patients with known adrenal insufficiency who are on inadequate daily doses or in situations with increased cortisol need.
Danish: Der kan udvikles akut binyrebarkinsufficiens hos patienter med kendt binyrebarkinsufficiens, som får utilstrækkelige daglige doser, eller i situationer med et øget behov for cortisol.
English: The medicine delivers hydrocortisone to your body throughout the day.
Danish: Dette lægemiddel sørger for hydrocortison til kroppen hele dagen igennem.
English: Changing from conventional oral glucocorticoid treatment to Plenadren When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given.
Danish: Skift fra konventionel oral glukokortikoidbehandling til Plenadren Når patienter skifter fra konventionel, oral hydrocortison-substitutionsbehandling givet tre gange daglig til Plenadren, kan der gives en identisk total daglig dosis.
English: Changing patients from hydrocortisone tablets given twice daily, cortisone acetate or synthetic glucocorticoids to Plenadren has not been studied, but changing to a hydrocortisone equivalent daily dose of Plenadren is recommended in these instances; further dose individualisation may be required.
Danish: Patienters skift fra hydrocortisontabletter givet to gange daglig, cortisonacetat eller syntetiske glukokortikoider til Plenadren er ikke blevet undersøgt, men skift til et hydrocortison svarende til den daglige dosis Plenadren anbefales i disse tilfælde; yderligere dosisjustering kan være nødvendig.
English: Hydrocortisone is eliminated completely by metabolism by 11ßHSD type 1 and type 2 enzymes and CYP 3A4 in the liver and in peripheral tissue.
Danish: Hydrocortison elimineres metabolisk fuldstændigt af 11ßHSD type 1 og type 2 enzymer og CYP 3A4
English: Plenadren is used in adults to treat a condition known as adrenal insufficiency, or cortisol deficiency.
Danish: Plenadren anvendes til voksne til behandling af en tilstand, der kaldes binyrebarkinsufficiens eller cortisolmangel.
English: INFORMATION IN BRAILLE Plenadren 20 mg
Danish: INFORMATION I BRAILLESKRIFT Plenadren 20 mg
English: Do not stop taking it without consulting your doctor.
Danish: Hold ikke op med at tage detuden først at have talt med Deres læge.
English: • More prone to infection
Danish: • Mere modtagelig for infektion
English: Scientific reports do not support immunosuppressive effects of hydrocortisone in doses that have been used for replacement therapy in patients with adrenal insufficiency.
Danish: Videnskabelige rapporter støtter ikke immunosuppressive virkninger af hydrocortison i doser, der har været anvendt til substitutionsbehandling hos patienter med binyrebarkinsufficiens.
English: - if your thyroid gland is not working normally tell your doctor since your dose of Plenadren may need to be adjusted.
Danish: - hvis Deres skjoldbruskkirtel ikke fungerer normalt, skal De fortælle det til Deres læge, da det måske vil være nødvendigt at justere Deres Plenadren-dosis.
English: Date of latest renewal: 8
Danish: Dato for første markedsføringstilladelse: 3. november 2011 Dato for seneste fornyelse: 8. august 2016
English: Infants of mothers taking high doses of systemic glucocorticoids for prolonged periods may be at risk of adrenal suppression.
Danish: Spædbørn af mødre, der tager høje doser systemiske glukokortikoider i længerevarende perioder, kan have risiko for binyrebarksuppression.
English: At the discretion of the treating physician, immediate release hydrocortisone tablets can be given instead of Plenadren or may be added to treatment.
Danish: Efter den behandlende læges vurdering kan der gives hydrocortisontabletter med umiddelbar udløsning af det aktive stof i stedet for Plenadren, eller de kan gives som supplement til behandlingen.
English: If you forget to take Plenadren
Danish: Hvis De har glemt at tage Plenadren
English: Animal studies have also shown that prenatal exposure to high doses of glucocorticoids (but lower than teratogenic doses) may be associated with increased risk of intrauterine growth retardation, cardiovascular disease in adulthood and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour.
Danish: Dyreforsøg har også vist, at prænatal eksponering til høje doser glukokortikoider (men lavere end teratogene doser) kan være forbundet med en øget risiko for intrauterin vækstretardering, kardiovaskulær sygdom i voksenalderen og permanente ændringer i glukokortikoidreceptordensitet, omsætning af signalstoffer samt opførsel.
English: Treatment in pregnant women with adrenal insufficiency is unlikely to cause any harmful effects on the mother and/or the baby.
Danish: Behandling til gravide kvinder med binyrebarkinsufficiens vil med sandsynlighed ikke påføre moderen og/eller barnet skadelige virkninger.
English: If you stop taking Plenadren
Danish: Hvis De holder op med at tage Plenadren
English: Naturally-occurring glucocorticoids (hydrocortisone and cortisol), which also have salt-retaining properties, are used as replacement therapy in adrenal insufficiency.
Danish: Naturligt forekommende glukokortikoider (hydrocortison og cortisol), som også har saltretinerende egenskaber, anvendes som substitutionsterapi ved binyrebarkinsufficiens.
English: Intravenous administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia, see section 4.4.
Danish: Intravenøs administration af hydrocortison er berettiget under forbigående sygdomsepisoder såsom svære infektioner, i særdeleshed gastroenteritis associeret med opkastning og/eller diaré, høj feber af enhver ætiologi eller voldsom fysisk stress som for eksempel alvorlige uheld eller kirurgi under generel anæstesi, se pkt.
English: Reproductive studies in animals have shown that glucocorticoids can cause foetal abnormalities and reproductive toxicity, see section 5.3.
Danish: Reproduktionsstudier med dyr har vist, at glukokortikoider kan medføre føtale abnormiteter og reproduktiv toksicitet, se pkt.
English: In less severe situations when intravenous administration of hydrocortisone is not required, for instance low grade infections, fever of any aetiology and stressful situations such as minor surgical procedures, the normal oral daily replacement dose must be increased temporarily; the total daily dose should be increased by administering the maintenance dose twice or thrice daily with 8 ±2 hours intervals (an increase in number of administrations, not increasing the morning dose).
Danish: I mindre alvorlige situationer, hvor der ikke kræves intravenøs administration af hydrocortison, for eksempel low-grade infektioner, feber af enhver ætiologi samt stressende situationer såsom mindre kirurgiske procedurer, skal den normale, daglige, orale substitutionsdosis øges midlertidigt; den totale daglige dosis bør øges ved administration af vedligeholdelsesdosis to eller tre gange daglig med 8 ±2 timers intervaller (en stigning i antallet af administrationer og ikke en stigning i morgendosen).
English: It should be swallowed whole; tablets should not be divided, chewed or crushed.
Danish: Tabletten skal synkes hel og må ikke deles, tygges eller knuses.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: - på anmodning fra Det Europæiske Lægemiddelagentur - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Hydrocortisone is excreted in breast milk.
Danish: Hydrocortison udskilles i modermælk.
English: Hydrocortisone is a glucocorticoid.
Danish: Hydrocortison er et glukokortikoid.
English: Hydrocortisone is a glucocorticoid and the synthetic form of endogenously produced cortisol.
Danish: Hydrocortison er et glukokortikoid og den syntetiske form af endogent produceret cortisol.
English: The 5 mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).
Danish: 5 mg tabletterne indeholder endvidere rød jernoxid (E172), gul jernoxid (E172) og sort jernoxid (E172).
English: Prolonged use of high doses of glucocorticoids may produce posterior subcapsular cataracts, and glaucoma with possible damage to the optic nerves.
Danish: Længerevarende brug af høje doser glukokortikoider kan forårsage posterior subkapsulær katarakt og glaukom med mulig beskadigelse af de optiske nerver.
English: Metabolism and nutrition disorders Sodium and water retention and oedema tendency, hypertension, hypokalaemia.
Danish: Metabolisme og ernæring Natrium- og vandretention og tendens til ødem, hypertension, hypokaliæmi.
English: The clinical response needs to be monitored in patients given medicinal products affecting gastric emptying and motility, see section 4.4.
Danish: Den kliniske respons skal overvåges hos patienter, der tager lægemidler, der påvirker gastrisk tømning og motilitet, se pkt.
English: Eye disorders Increased intraocular pressure and cataract.
Danish: Øjne Øget intraokulært tryk og katarakt.
English: • Stomach pain/heartburn, feeling sick or nauseated
Danish: • Mavepine/halsbrand, kvalme
English: Psychiatric adverse reactions may occur with systemic glucocorticoids.
Danish: Der kan optræde psykiatriske bivirkninger i forbindelse med systemiske glukokortikoider.
English: Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations).
Danish: Dyreforsøg har vist, at prænatal eksponering til meget høje doser glukokortikoider kan medføre misdannelser (ganespalte, knoglemisdannelser).
English: This may require dose individualisation.
Danish: Dette kan gøre dosisindividualisering nødvendig.
English: The study compared modified-release tablets given once daily with conventional tablets given three times daily using the same daily dose of hydrocortisone (20 to 40 mg).
Danish: Forsøget sammenlignede tabletter med modificeret udløsning givet én gang daglig med konventionelle tabletter givet tre gange daglig ved brug af den samme daglige dosis hydrocortison (20 til 40 mg).
English: • Rifampicin or rifabutin - used to treat tuberculosis
Danish: • Rifampicin eller rifabutin - anvendes til behandling af tuberkulose
English: These medicines have also been given for other indications than adrenal insufficiency replacement therapy, often in higher doses.
Danish: Disse lægemidler er også givet for andre indikationer end substitutionsterapi ved binyrebarkinsufficiens, og ofte i en højere dosis.
English: There is no indication that hydrocortisone replacement therapy in pregnant women with adrenal insufficiency is associated with adverse outcome of the mother and/or the foetus.
Danish: Der er intet, der tyder på, at hydrocortisonsubstitutionsbehandling hos gravide kvinder med binyrebarkinsufficiens associeres med ugunstigt udfald for moderen og/eller fostret.
English: Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines.
Danish: Dårligt behandlet eller ubehandlet binyrebarkinsufficiens nedsætter evnen til at koncentrere sig og vil påvirke evnen til at føre motorkøretøj og betjene maskiner.