FrancophonIA/ELRC3.0 huggingface dataset:
English: This regimen has been documented in over 300 intercurrent illness episodes within the clinical study programme.
Danish: Dette regimen er dokumenteret i over 300 interkurrente sygdomsepisoder inden for det kliniske forsøgs program.
English: The clinical response should be monitored in patients with these conditions.
Danish: Den kliniske respons bør overvåges hos patienter med disse tilstande.
English: • Weakening of the bones - this may cause bone fractures
Danish: • Svækkelse af knoglerne - dette kan forårsage knoglebrud
English: This may occur during commencement of treatment and during dose adjustments.
Danish: Dette kan forekomme i starten af behandlingen og under dosisjusteringer.
English: In which case, symptomatic treatment should be instituted as necessary.
Danish: I et sådant tilfælde bør symptomatisk behandling iværksættes efter behov.
English: The effect of corticosteroids may be reduced for 3-4 days after treatment with mifepristone.
Danish: Virkningen af kortikosteroider kan være reduceret i 3-4 dage efter behandling med mifepriston.
English: Stopping Plenadren may be life threatening.
Danish: At holde op med at tage Plenadren kan være livstruende.
English: If you have forgotten to take your tablet in the morning, take it as soon as possible thereafter.
Danish: Hvis De har glemt at tage Deres tablet om morgenen, skal De tage den, så snart De kommer i tanker om det.
English: The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established.
Danish: Plenadrens sikkerhed og virkning hos børn/unge under 18 år er endnu ikke klarlagt.
English: - if for any other reason your general health is declining although you take your medicine as prescribed; seek immediate medical care.
Danish: - hvis Deres generelle helbred af en hvilken som helst anden grund bliver dårligere, selv om De tager Deres medicin som ordineret; søg omgående lægehjælp.
English: Plenadren is not recommended for use in children and adolescents under 18 years old as it has not been studied in these patients.
Danish: Plenadren bør ikke anvendes hos børn og unge under 18 år, da det ikke er blevet undersøgt hos disse patienter.
English: • Diabetes or problems with blood sugar levels (shown in blood tests)
Danish: • Diabetes eller problemer med blodsukkerniveauet (påvist i blodprøver)
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer)
English: Concomitant infections
Danish: Samtidige infektioner
English: It is important that you continue treatment with Plenadren during pregnancy.
Danish: Det er vigtigt, at De fortsætter behandlingen med Plenadren under graviditet.
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Danish: De anvendes endvidere i kraft af deres potente antiinflammatoriske virkninger ved lidelser i mange organsystemer.
English: Fatigue has been reported as very common.
Danish: Træthed er indberettet som meget almindelig.
English: Most reactions resolve after dose reduction, although specific treatment may be necessary.
Danish: De fleste reaktioner forsvinder efter dosisreduktion, men særlig behandling kan være nødvendig.
English: Talk to your doctor if you experience any of these side effects:
Danish: Tal med lægen, hvis De oplever en af disse bivirkninger:
English: Events have been reported in patients treated with Plenadren.
Danish: Der er blevet indberettet hændelser hos patienter i behandling med Plenadren.
English: Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Danish: Shire Pharmaceuticals Ireland Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
English: • You should preferably be in an upright position.
Danish: • De bør helst være i en oprejst stilling, når De tager Deres medicin.
English: If you experience any signs or symptoms listed in the section “The need for additional doses of Plenadren”, contact your doctor immediately.
Danish: Hvis De oplever et eller flere af de tegn og symptomer, der er anført i afsnittet ”Behov for yderligere doser Plenadren”, skal De straks kontakte lægen.
English: If extra doses are needed frequently and regularly, you should contact your doctor for re-evaluation of your maintenance dose.
Danish: Hvis der ofte og regelmæssigt er behov for ekstra doser, bør De kontakte Deres læge og få Deres vedligeholdelsesdosis revurderet.
English: Using higher than normal doses of hydrocortisone
Danish: Brug af højere end normale doser hydrocortison
English: A common maintenance dose is 20-30 mg per day, given once daily in the morning.
Danish: En almindelig vedligeholdsdosis er 20-30 mg per dag, givet én gang daglig om morgenen.
English: Paediatric population No pharmacokinetic data are available in children or adolescents.
Danish: Pædiatrisk population Der foreligger ingen farmakokinetiske data hos børn/unge.
English: It belongs to a group of medicines called corticosteroids.
Danish: Det tilhører en gruppe lægemidler, der kaldes kortikosteroider.
English: If it is not enough to double the daily dose, you should take a third dose 6 to 10 hours after the second dose (6-10 hour intervals between doses).
Danish: Hvis det ikke er nok at fordoble den daglige dosis, bør De tage en tredje dosis 6 til 10 timer efter den anden dosis (6-10 timers intervaller mellem doserne).
English: However, talk to your doctor if you plan to breast-feed your baby.
Danish: De bør dog tale med Deres læge, hvis De planlægger at amme Deres spædbarn.
English: If more than one daily administration is required the morning dose should be given as instructed, additional doses given later during the day can be given with or without food.
Danish: Hvis der er behov for mere end én daglig administration, skal morgendosis indtages som anvist, og yderligere doser senere på dagen kan indtages med eller uden mad.
English: You should then take the second dose of this medicine 6 to 10 hours after the morning dose.
Danish: De bør da tage den anden dosis af lægemidlet 6 til 10 timer efter morgendosen.
English: The need for additional doses of Plenadren
Danish: Behov for yderligere doser Plenadren
English: Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Danish: Indberetninger af akut toksicitet og/eller dødsfald efter overdosering med hydrocortison er sjældne.
English: Glucocorticoids occur naturally in the body, and help to maintain your general health and well-being.
Danish: Glukokortikoider forekommer naturligt i kroppen og hjælper med til at opretholde Deres gode helbred og velbefindende.
English: It is therefore important to continue taking this medicine as prescribed by your doctor.
Danish: Det er derfor vigtigt at fortsætte med at tage lægemidlet som ordineret af Deres læge.
English: In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
Danish: Hos patienter med nogen resterende endogen cortisolproduktion kan en lavere dosis være tilstrækkelig.
English: The terminal half-life of cortisol following administration of Plenadren was about 3 hours and formulation release controlled.
Danish: Den terminale halveringstid af cortisol efter administration af Plenadren var cirka 3 timer med kontrolleret udløsning af formuleringen.
English: Your blood pressure may increase, you may gain extra weight and your blood sugar may become too high.
Danish: Blodtrykket kan stige, måske vil De tage på i vægt, og Deres blodsukkerniveau kan blive for højt.
English: A small amount of cortisol is excreted in the urine unchanged (<0.5% of the daily production), meaning that cortisol is eliminated completely by metabolism.
Danish: En lille mængde cortisol udskilles uændret i urinen (<0,5 % af den daglige produktion), hvilket betyder, at cortisol elimineres fuldstændigt ved metabolisme.
English: If you are changing treatment from other hydrocortisone tablets to Plenadren you may experience side effects during the first weeks.
Danish: Hvis De skifter behandling fra andre hydrocortisontabletter til Plenadren, kan De få bivirkninger i løbet af de første uger.
English: Ask your doctor promptly for information on how you should handle these situations.
Danish: Bed straks Deres læge om information om, hvordan De skal håndtere sådanne situationer.
English: Plenadren is given as maintenance therapy.
Danish: Plenadren gives som vedligeholdelsesterapi.
English: They will normally disappear with time, if not contact your doctor.
Danish: Bivirkningerne vil normalt forsvinde i løbet af nogen tid, men hvis de ikke gør det, skal De kontakte Deres læge.
English: The dose must therefore be increased temporarily and your doctor may advise you to use other hydrocortisone tablets instead of, or in addition to Plenadren.
Danish: Deres dosis skal derfor øges midlertidigt, og Deres læge vil muligvis råde Dem til at tage andre hydrocortisontabletter i stedet for - eller samtidig med Plenadren.
English: OTHER Shire Services BVBA
Danish: ANDET Shire Services BVBA
English: A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies.
Danish: I alt er 80 patienter (173 patient-år til dato) blevet behandlet med hydrocortison med modificeret udløsning i kliniske forsøg.
English: An increased dose is necessary occasionally in order for the body to cope with increased stress such as fever.
Danish: En øget dosis er nødvendig i særlige tilfælde for at få kroppen til at klare sig i forbindelse med øget stress som for eksempel feber.
English: If you are affected do not drive or use machines, until you have discussed the issue with your doctor.
Danish: Hvis De bliver påvirket af medicinen, må De ikke føre motorkøretøj eller betjene maskiner, før De har drøftet emnet med Deres læge.
English: This may require dose adjustment of hydrocortisone.
Danish: Dette kan kræve dosisjustering af hydrocortison.
English: Frequency of adverse reactions Very common Common
Danish: Hyppighed af bivirkninger Meget almindelig
English: If used with mifepristone, a treatment used to end a pregnancy, the effect of Plenadren may be reduced.
Danish: Hvis Plenadren anvendes sammen med mifepriston, som er et lægemiddel, der anvendes til at afslutte en graviditet, kan virkningen af Plenadren blive nedsat.
English: The absorption rate of hydrocortisone was reduced after food intake resulting in a delay in the time to maximal concentration in plasma from on average less than 1 hour to over 2.5 hours.
Danish: Absorptionshastigheden af hydrocortison blev reduceret efter fødeindtagelse, hvilket resulterede i en forsinkelse i tid til maksimal koncentration i plasma fra i gennemsnit mindre end 1 time til mere end 2,5 time.
English: Following oral administration, hydrocortisone is rapidly and well absorbed from the gastrointestinal tract and the absorption has been reported to be more than 95% for an oral 20 mg dose (tablets).
Danish: Efter oral administration absorberes hydrocortison hurtigt og effektivt fra mave-tarm-kanalen, og absorptionen er rapporteret at være mere end 95 % for en oral 20 mg dosis (tabletter).
English: The dose is specific for you and is decided by your doctor.
Danish: Deres dosis er specielt valgt til Dem af Deres læge.
English: Once the intercurrent illness episode is over, patients can return to the normal maintenance dose.
Danish: Så snart den interkurrente sygdomsepisode er ovre, kan patienterne vende tilbage til den normale vedligeholdelsesdosis.
English: Gastric emptying and motility disorders
Danish: Gastrisk tømning og motilitetsforstyrrelser
English: Not all pack sizes may be available in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i Deres land.
English: Untreated adrenal insufficiency during pregnancy is associated with poor outcome of both the mother and the foetus, therefore it is important to continue treatment during pregnancy.
Danish: Ubehandlet binyrebarkinsufficiens under graviditet associeres med dårligt udfald hos både moderen og fostret, og det er derfor vigtigt at fortsætte behandlingen under graviditet.
English: The daily dose of Plenadren may have to be doubled or tripled in milder conditions such as a mild infection or stress.
Danish: Det vil muligvis være nødvendigt at fordoble eller tredoble Deres daglige dosis Plenadren i lette sygdomstilfælde som for eksempel mild infektion eller stress.
English: The terminal half-life has been reported to be about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets.
Danish: Den terminale halveringstid er rapporteret at være 1,5 timer efter intravenøs og oral dosering af hydrocortisontabletter.
English: Treatment of adrenal insufficiency in adults.
Danish: Behandling af binyrebarkinsufficiens hos voksne.
English: Please discuss this with your doctor and follow the instructions on how to act in these situations.
Danish: De bør drøfte dette med Deres læge og følge lægens anvisninger i, hvorledes De skal handle i sådanne situationer.
English: • St. John's wort - used to treat depression and other conditions
Danish: • Prikbladet perikum - anvendes til behandling af depression og andre tilstande
English: Immune system disorders Activation of infection (tuberculosis, fungal and viral infections including herpes).
Danish: Immunsystemet Aktivering af infektion (tuberkulose, svampe- og virusinfektioner herunder herpes).
English: Psychiatric disorders Euphoria and psychosis, insomnia.
Danish: Psykiske forstyrrelser Eufori og psykose, insomni.
English: Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone.
Danish: Behandling er sandsynligvis ikke indiceret til reaktioner, der skyldes kronisk forgiftning, medmindre patienten har en tilstand, der ville gøre ham/hende usædvanlig modtagelig over for dårlige virkninger fra hydrocortison.
English: Therefore, there is no reason to believe that replacement doses of hydrocortisone will exacerbate any systemic infection or worsen the outcome of such an infection.
Danish: Der er derfor ingen grund til at tro, at substitutionsdoser af hydrocortison vil forværre en systemisk infektion eller forværre udfaldet af en sådan infektion.
English: These side effects can be: stomach pain, feeling sick and tiredness.
Danish: Disse bivirkninger kan være: ondt i maven, kvalme og træthed.
English: If you are to have surgery, tell your doctor/dentist before the surgery that you are taking this medicine.
Danish: Hvis De skal gennemgå kirurgi, skal De forinden fortælle Deres læge/tandlæge, at De tager dette lægemiddel.
English: Treatment of primary adrenal insufficiency often warrants addition of a mineralocorticoid.
Danish: Behandling af primær binyrebarkinsufficiens berettiger ofte tilføjelse af et mineralokortikoid.
English: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgium
Danish: Shire Services BVBA Rue Montoyer 47 B - 1000 Bruxelles Belgien
English: 40 mg is the highest maintenance dose studied.
Danish: Den højeste vedligeholdelsesdosis, der er undersøgt, er 40 mg.
English: The pivotal study was a randomised, two-period 12-week crossover multi-centre trial in 64 patients with primary adrenal insufficiency, 11 of whom had concomitant diabetes mellitus and 11 had hypertension.
Danish: Det pivotale studie var et randomiseret, 12 ugers, cross-over, multicenterforsøg med 2 perioder med 64 patienter med primær binyrebarkinsufficiens, hvoraf 11 havde samtidig diabetes mellitus, og 11 havde hypertension.
English: Plenadren can be used during pregnancy.
Danish: Plenadren kan anvendes under graviditeten.
English: Glucocorticoids cause profound and varied metabolic effects.
Danish: Glukokortikoider giver omfattende og forskelligartede metaboliske virkninger.
English: During long-term prophylactic treatment with any of the antibiotics, adjustment of the hydrocortisone dosage should be considered.
Danish: Under langvarig, profylaktisk behandling med et af disse antibiotika bør justering af hydrocortisondosis overvejes.
English: The transport of cortisol across membranes is expected to be mediated mainly by passive diffusion and therefore renal and biliary clearances are negligible.
Danish: Transport af cortisol gennem membraner forventes at være medieret hovedsageligt ved passiv diffusion, og derfor er nyre- og galde-clearance ubetydelig.
English: Plenadren contains a substance called hydrocortisone (sometimes called cortisol).
Danish: Plenadren indeholder et stof, der kaldes hydrocortison (det kaldes også cortisol).
English: Dosing according to individual clinical response is recommended.
Danish: Det anbefales at fastsætte dosis ifølge individuel klinisk respons.
English: This terminal half-life is similar to the pharmacokinetics of endogenous cortisol that also is secretion-controlled.
Danish: Denne terminale halveringstid ligner farmakokinetikken af endogent cortisol, der også er sekretionsstyret.
English: When your illness is over, return to your normal maintenance dose of this medicine.
Danish: Når Deres sygdom er ovre, skal De vende tilbage til Deres normale vedligeholdelsesdosis af lægemidlet.
English: CYP 3A4 is involved in the clearance of cortisol by the formation of 6β-hydroxycortisol which is excreted in urine.
Danish: CYP 3A4 er involveret i cortisols clearance ved dannelse af 6β hydroxycortisol, som udskilles i urin.
English: This may happen when you have stomach problems involving vomiting and/or diarrhoea.
Danish: Dette kan være tilfældet, hvis De har maveproblemer, der omfatter opkastning og/eller diaré.
English: There is no indication that Plenadren, in doses used for replacement therapy, will have an effect on fertility.
Danish: Der er ingen indikation for, at Plenadren, i doser, der anvendes i substitutionsterapi, vil have en virkning på frugtbarheden.
English: Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels.
Danish: Hydrocortison gives som en substitutionsterapi, der stiler efter at genskabe normale cortisolniveauer.
English: Additional side effects have been reported for other hydrocortisone medicines.
Danish: Der er indberettet yderligere bivirkninger i forbindelse med andre hydrocortison-lægemidler.
English: The dose of hydrocortisone should be carefully monitored during pregnancy in women with adrenal insufficiency.
Danish: Hydrocortisondosis bør overvåges omhyggeligt under graviditet hos kvinder med binyrebarkinsufficiens.
English: Hydrocortisone is a class II active substance according to the biopharmaceutical classification system (BCS) with a high intestinal permeability and a low dissolution rate, especially at higher doses.
Danish: Hydrocortison er et klasse II aktivt stof ifølge det biofarmaceutiske klassifikationssystem (BCS) med en høj intestinal permeabilitet og en lav opløsningshastighed, især ved højere doser.
English: In plasma, cortisol is bound to corticosteroid-binding globulin (CBG, also called transcortin) and albumin.
Danish: Cortisol er bundet i plasma til kortikosteroidbindende globulin (CBG - også kaldet transcortin) og albumin.
English: In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral, preferably intravenous treatment.
Danish: I alvorlige situationer kræves en øjeblikkelig dosisøgning, og oral administration af hydrocortison skal erstattes med parenteral, helst intravenøs behandling.
English: The immediate-release part provides a rapid onset of absorption and the extended-release part provides a more extended plasma profile of cortisol.
Danish: Den umiddelbare udløsning giver en hurtig start på absorptionen, og den forlængede udløsning giver en mere forlænget plasmaprofil af cortisol.
English: Do not take this medicine with grapefruit juice as the juice will conflict with the action of this medicine.
Danish: Drik ikke grapefrugtjuice, mens De tager Plenadren, da grapefrugtjuice vil forstyrre virkningen af dette lægemiddel.
English: Adrenal insufficiency occurs when your adrenal glands (just above your kidneys) do not produce enough of the hormone cortisol.
Danish: Binyrebarkinsufficiens optræder, når binyrerne (lige over nyrerne) ikke producerer nok af hormonet cortisol.
English: If divided, crushed or chewed this may prevent the hydrocortisone dose in the tablet to cover the whole day, as it should.
Danish: Hvis tabletterne deles, knuses eller tygges, kan det forhindre hydrocortison-dosen i at dække hele dagen, som den bør.
English: Compared to conventional tablets given three times daily, once daily modified-release tablets resulted in an increased cortisol exposure during the first four hours after intake in the morning but reduced exposure in the late afternoon/evening and over the 24-hour period (Figure 1).
Danish: Sammenlignet med konventionelle tabletter givet tre gange daglig resulterede tabletter med modificeret udløsning givet én gang daglig i en øget cortisol-eksponering i de første fire timer efter indtagelse om morgenen, men reducerede eksponeringen sent om eftermiddagen/aftenen og over perioden på 24 timer (figur 1).
English: Patients should be instructed to take Plenadren orally with a glass of water on awakening at least 30 minutes before food intake, preferably in an upright position and between 6.00 am and 8.00 am in the morning.
Danish: Patienterne bør instrueres i at tage Plenadren oralt med et glas vand, når de vågner og mindst 30 minutter inden indtagelse af mad - helst i oprejst stilling og mellem kl. 06 og 08 om morgenen.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: However, seek immediate medical help if you notice any of the following: severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, reduced consciousness, delirium (very confused state).
Danish: De skal imidlertid søge øjeblikkelig lægehjælp, hvis De bemærker noget af følgende: alvorlig svaghed, besvimelse, mavesmerter, kvalme, opkastning, rygsmerter, forvirring, nedsat bevidsthed, delirium (meget forvirret tilstand).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FLASKE
English: You should tell your doctor if you become pregnant as the dose of Plenadren may have to be adjusted.
Danish: De bør fortælle det til Deres læge, hvis De bliver gravid, da det muligvis vil være nødvendigt at justere Deres Plenadren-dosis.
English: In situations when the body is exposed to excessive physical and/or mental stress, patients may need additional substitution of immediate release hydrocortisone tablets especially in the afternoon/evening, see also section ‘Use in intercurrent illness' where other ways of temporarily increasing the dose of hydrocortisone is described.
Danish: I situationer, hvor kroppen udsættes for voldsom fysisk og/eller mental stress, kan patienterne have behov for yderligere substitution af hydrocortisontabletter med umiddelbar udløsning, især om eftermiddagen/aftenen, se endvidere afsnittet ‘Anvendelse i forbindelse med interkurrent sygdom', der beskriver andre måder til midlertidigt at øge dosen af hydrocortison.
English: Symptoms may range from excitement/arousal to mania or psychosis.
Danish: Symptomer på overdosering kan spænde fra begejstring/ophidselse til mani eller psykose.
English: Oral replacement doses must be individualised according to the clinical response.
Danish: Orale substitutionsdoser skal tilpasses den enkelte efter klinisk respons.
English: INFORMATION IN BRAILLE Plenadren 5 mg
Danish: INFORMATION I BRAILLESKRIFT Plenadren 5 mg
English: Since severe renal impairment may affect medicinal products completely eliminated via metabolism, dose adjustment may be needed.
Danish: Da svær nyreinsufficiens kan påvirke lægemidlets fuldstændige elimination via metabolisme, kan dosisjustering være nødvendig.