FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be given to patients with severe liver or kidney disease, patients with a disease causing inflammation of the bowel, or patients with certain problems affecting the heart or blood vessels.
Danish: Det må ikke gives til patienter, der har svære lever- eller nyresygdomme, patienter med sygdomme, der forårsager betændelse i tarmen, eller patienter med visse problemer, der påvirker hjertet eller blodkarrene.
English: Onsenal must not be given to patients with severe liver or kidney problems.
Danish: Onsenal må ikke gives til patienter med svære lever- eller nyreproblemer.
English: By blocking the activity of COX-2, celecoxib helps to slow down the formation of polyps by stopping them developing their own blood supply and by increasing the rate of cell death.
Danish: Celecoxib blokerer COX-2-enzymets aktivitet og bidrager derved til at hæmme dannelsen af polypper, idet det forhindrer dem i at udvikle deres egen blodforsyning og øger den hastighed, hvormed cellerne dør.
English: It must not be used in patients who have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type reactions after taking aspirin or an NSAID, including another COX-2 inhibitor.
Danish: Det må ikke anvendes til patienter, som har aktive sår eller blødninger i mave eller tarm, eller til patienter, som har haft overfølsomhedslignende reaktioner, efter at de har taget aspirin eller et NSAID, herunder en anden COX-2-hæmmer.
English: In patients with moderate liver disease, the dose of Onsenal should be halved.
Danish: Patienter med moderat leversygdom skal have halv dosis Onsenal.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal is available
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Onsenal findes her.
English: Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Danish: Onsenal anvendes som et supplement til kirurgi (til at fjerne polypperne) og endoskopisk kontrol, hvor lægen anvender et endoskop, som er et tyndt rør, til at se ind i tarmen og derved kontrollere, om polypperne udvikler sig.
English: Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Danish: Onsenal må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for celecoxib, et eller flere af indholdsstofferne eller sulfonamider (såsom visse antibiotika).
English: This is a genetic disease that causes ‘adenomatous intestinal polyps', growths that project from the lining of the colon or rectum (large intestine).
Danish: Det er en genetisk sygdom, der forårsager adenomatøse polypper i tarmen, dvs. udvækster på indersiden af colon eller rectum (endetarmen).
English: COX-2 is found at high levels in adenomatous colorectal polyps.
Danish: COX-2 findes i høje koncentrationer i adenomatøse polypper i tyktarmen og endetarmen.
English: For the full list of restrictions, see the
Danish: Den fuldstændige liste over begrænsningerne fremgår af indlægssedlen.
English: Onsenal also reduced the number of polyps in patients aged 10 to 14
Danish: Onsenal nedsatte også antallet af polypper hos patienter i alderen 10 til 14 år med FAP.
English: A lower starting dose may be needed in patients whose bodies may break Onsenal down slowly.
Danish: Patienter, hvis krop nedbryder Onsenal langsomt, skal muligvis have en lavere startdosis.
English: How does Onsenal work?
Danish: Hvordan virker Onsenal?
English: For the full list of all side effects reported with Onsenal, see the
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Onsenal fremgår af indlægssedlen.
English: What benefit has Onsenal shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Onsenal?
English: It is available as white capsules
Danish: Det fås som hvide kapsler (200 og 400 mg).
English: The usual medical care for FAP
Danish: Den normale behandling af FAP-patienter skal fortsættes.
English: Frequency: not known
Danish: Hyppighed: ikke kendt
English: After first opening: 60 days.
Danish: Efter første åbning: 60 dage.
English: Date of first authorisation: 09 February 2018
Danish: Dato for første markedsføringstilladelse: 09. februar 2018
English: If your child becomes unwell
Danish: Hvis dit barn får det dårligt
English: Strength (ink colour) Also contains:
Danish: Styrke (blækfarve) Indeholder også:
English: The lowest possible dosage should be used.
Danish: Den lavest mulige dosis bør anvendes.
English: 68.8% of healthy adult volunteers have described the taste as neutral.
Danish: 68,8 % af de raske voksne forsøgspersoner har beskrevet smagen som neutral.
English: ATC code: H02AB09
Danish: ATC-kode: H02AB09
English: In addition they modify the body's immune responses to diverse stimuli.
Danish: Desuden modificerer de kroppens immunrespons på diverse stimuli.
English: Infections and immunisation
Danish: Infektioner og immunisering
English: Alkindi with food and drink
Danish: Brug af Alkindi sammen med mad og drikke
English: 50 capsules
Danish: 50 kapsler
English: These include: - Grapefruit juice.
Danish: Disse omfatter: - Grapefrugtjuice - Lakrids
English: Infants require frequent assessment and should be evaluated at a minimum every 3 to 4 months to assess growth, blood pressure, and general well-being.
Danish: Spædbørn kræver hyppig evaluering og bør kontrolleres mindst hver 3.-4. måned til vurdering af vækst, blodtryk og almentilstand.
English: In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening.
Danish: I situationer, hvor kroppen udsættes for voldsom fysisk og/eller psykisk stress, kan patienterne have brug for en øget dosis, navnlig om eftermiddagen eller aftenen.
English: Tel. +31 (0)20 6615 072 info@diurnal.co.uk
Danish: Tlf. +31 (0)20 6615 072 info@diurnal.co.uk
English: Symptoms typically emerge within a few days or weeks of starting the treatment.
Danish: Symptomerne ses typisk få dage eller uger efter påbegyndelse af behandlingen.
English: Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: The need for dose adjustment when such medicinal products are used can be anticipated and patients should be closely monitored.
Danish: Behov for dosisjustering ved brug af sådanne lægemidler kan forventes, og patienterne bør overvåges nøje.
English: intense feeling of happiness and excitement (euphoria).
Danish: intens følelse af lykke og opstemthed (eufori).
English: The binding is accounted for by two protein fractions.
Danish: Bindingen sker ved to proteinfraktioner.
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Danish: De anvendes desuden på grund af deres potente antiinflammatoriske effekt ved lidelser i mange organsystemer.
English: Psychosis with hallucinations and delirium Mania
Danish: Psykose med hallucinationer og delirium Mani
English: The biological half-life of hydrocortisone is about 100 minutes.
Danish: Den biologiske halveringstid for hydrocortison er ca. 100 minutter.
English: Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 France
Danish: Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 Frankrig
English: During stress it may be necessary to increase the dose temporarily.
Danish: Ved stresspåvirkning kan det være nødvendigt at øge dosis midlertidigt.
English: There were no adverse reactions and no episodes of adrenal crisis seen in any of the studies.
Danish: Der sås ingen bivirkninger eller episoder med Addison krise i nogen af studierne.
English: As Alkindi is replacing the normal hormone your child lacks, side effects are uncommon, however:
Danish: Da Alkindi erstatter det naturlige hormon, som dit barn mangler, er bivirkninger ualmindelige; men:
English: As this was a single-dose study, the primary efficacy assessment was serum cortisol at 60 minutes.
Danish: Da der var tale om et enkeltdosis-studie, var det primære effektmål cortisol-niveauet i serum efter 60 minutter.
English: Six of the 12 children in Cohort 1 (age range 2.6 to 4.7 years) responded to an adjusted palatability questionnaire.
Danish: 6 ud af 12 børn i kohorte 1 (i alderen 2,6-4,7 år) besvarede et justeret spørgeskema vedrørende smagen.
English: Stopping the medicine suddenly could quickly make your child very unwell.
Danish: Ved pludseligt ophør med medicinen kan barnet hurtigt få det meget dårligt.
English: Van Heuven Goedhartlaan 935 A 1181LD Amstelveen The Netherlands
Danish: Van Heuven Goedhartlaan 935 A 1181LD Amstelveen Holland
English: Taking Alkindi should not stop your child being vaccinated.
Danish: Behandling med Alkindi bør ikke forhindre dit barn i at blive vaccineret.
English: Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein.
Danish: Fordeling 90 % eller derover af cirkulerende hydrocortison er reversibelt bundet til protein.
English: The capsule shell must not be swallowed but carefully be opened as follows:
Danish: Kapselskallen må ikke sluges, men skal åbnes forsigtigt på følgende måde:
English: - If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth.
Danish: - hvis dit barn har svært ved at synke mad, eller hvis der er tale om en for tidligt født baby, der endnu ikke får mad gennem munden.
English: - The capsule is made from hypromellose.
Danish: - Kapslen er fremstillet af hypromellose.
English: The study consisted of three consecutive cohorts, the first including 12 patients aged 2 to less than 6 years, the second including 6 patients aged 28 days to less than 2 years, and the third including 6 neonates aged from birth to less than 28 days.
Danish: Studiet bestod af tre konsekutive kohorter, hvoraf den første omfattede 12 patienter i alderen 2 til < 6 år, den anden omfattede 6 patienter i alderen 28 dage til < 2 år, og den tredje omfattede 6 nyfødte i alderen 0 til < 28 dage.
English: Treatment should be limited to the minimum dosage required to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual.
Danish: Behandlingen skal begrænses til mindst mulige dosis til opnåelse af den ønskede kliniske respons, og når det er muligt at reducere dosen, skal dette gøres gradvist.
English: 1 patient had renal hypoplasia, 1 patient atopic dermatitis and 1 patient had rhinitis.
Danish: 1 patient havde nyrehypoplasi, 1 patient havde atopisk dermatitis, og 1 patient havde rhinitis.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i appendiks V.
English: Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4).
Danish: Hydrocortison metaboliseres via cytokrom P450 3A4 (CYP3A4).
English: In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Danish: I alvorlige situationer kræves en øjeblikkelig dosisøgning, og oral administration af hydrocortison skal erstattes med parenteral behandling.
English: The coadministration of Alkindi with soft food (yoghurt and fruit puree) has been studied in vitro with no significant effect on dissolution seen.
Danish: Administration af Alkindi sammen med blød mad (yoghurt eller frugtmos) er undersøgt in vitro, hvor der ikke er set nogen signifikant effekt på opløsning.
English: Each carton contains 1 bottle.
Danish: Hver æske indeholder 1 beholder.
English: In all 24 patients Alkindi was found to increase cortisol values from baseline as expected: median baseline cortisol 14.1 mmol/l (range 14.1 - 104.5), median Cmax 535.2 mmol/l (range 346.2 - 1445.1).
Danish: Hos alle 24 patienter øgede Alkindi cortisol-værdierne i forhold til baseline som forventet: median cortisol-værdi ved baseline 14,1 mmol/l (interval 14,1-104,5), median Cmax 535,2 mmol/l (interval 346,2-1445,1).
English: unwell or has an infection.
Danish: hvis han/hun har det dårligt eller har en infektion.
English: Among parents and carers asked about their child's experience of taking the medication (n=23), 82.6% agreed/strongly agreed that their child found swallowing Alkindi easy; 65.2% agreed/strongly agreed that their child showed a positive reaction after Alkindi administration; 95.5% would be happy to give their child Alkindi in the future; and 95.5% said that they would prefer Alkindi for their child's treatment over their usual hydrocortisone formulation.
Danish: Blandt forældre og omsorgspersoner, der blev spurgt om deres barns oplevelse ved indtagelse af lægemidlet (n = 23), svarede 82,6 %, at de var enige/meget enige i, at deres barn fandt det let at synke Alkindi; 65,2 % svarede, at de var enige/meget enige i, at deres barn udviste en positiv reaktion efter indgivelsen af Alkindi; 95,5 % svarede, at de gerne ville give deres barn Alkindi fremadrettet, og 95,5 % svarede, at de ville foretrække Alkindi til behandling af deres barn frem for den sædvanlige formulering af hydrocortison.
English: Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.
Danish: Lige efter administrationen skal barnet have noget at drikke, f.eks. vand, mælk, brystmælk eller modermælkserstatning, for at sikre, at alt granulatet synkes.
English: ≥50% subjects reported that the taste, feel in mouth and ease of swallowing were very good and that they were likely to take the medicinal product again.
Danish: ≥ 50 % af patienterne svarede 'meget god' til smagen, fornemmelsen i munden og synkeligheden, og at de sandsynligvis ville tage lægemidlet igen.
English: Glucocorticoids cause profound and varied metabolic effects.
Danish: Glucocorticoider giver omfattende og forskelligartede metaboliske virkninger.
English: Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Danish: De fleste bivirkninger svinder efter dosisreduktion eller seponering, men specifik behandling kan være nødvendig.
English: - Some adult patients taking hydrocortisone (similar to Alkindi) became anxious, depressed or confused.
Danish: - Nogle voksne patienter i behandling med hydrocortison (svarende til Alkindi) har oplevet angst, depression eller forvirring.
English: A total of 30 healthy (but dexamethasone-suppressed) adult male subjects in two phase 1 studies and 24 paediatric patients with adrenal insufficiency in two phase 3 studies have been treated with Alkindi.
Danish: I alt 30 raske (men dexamethason-supprimerede) voksne mandlige forsøgspersoner i to fase 1-studier og 24 pædiatriske patienter med binyreinsufficiens i to fase 3-studier er blevet behandlet med Alkindi.
English: - Changes in blood potassium levels, leading to excessive alkalinity of body tissues or fluids (hypokalaemic alkalosis).
Danish: - Ændringer i blodets kaliumniveau, der kan føre til forhøjet alkalinitet i kropsvæv eller kropsvæsker (hypokaliæmisk alkalose).
English: Hypokalaemic alkalosis
Danish: Hypokaliæmisk alkalose
English: Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Danish: Erstatningsterapi ved binyreinsufficiens hos spædbørn, børn og unge (fra 0 til <18 år).
English: This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
Danish: Denne type relativ insufficiens kan vare ved i flere måneder efter seponering af behandlingen; hvis der opstår stressende situationer i den periode, bør behandling med corticosteroid derfor genoptages.
English: One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.
Danish: Den ene proteinfraktion, corticosteroid-bindende globulin, er et glykoprotein; den anden proteinfraktion er albumin.
English: If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use.
Danish: Hvis granulatet hældes ud på en skefuld blød mad, skal det indgives med det samme (inden for 5 minutter) og må ikke gemmes til senere.
English: Detailed pictograms on how to administer the granules are provided in the package leaflet.
Danish: Detaljerede piktogrammer, som illustrerer, hvordan granulatet skal administreres, fremgår af indlægssedlen.
English: Alkindi was positively assessed in terms of palatability.
Danish: Alkindi blev vurderet positivt, hvad smagen angår.
English: The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule.
Danish: Granulatet er hvidt til offwhite og er indeholdt i en gennemsigtig, farveløs hård kapsel (størrelse 00el).
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 formodentlig ikke indiceret ved reaktioner, der skyldes kronisk forgiftning, medmindre patienten har en tilstand, der gør ham/hende særligt modtagelig over for uønskede virkninger ved hydrocortison.
English: - In some patients with allergies to other medicines, allergy to hydrocortisone has been seen.
Danish: - Hos nogle patienter med allergier over for andre lægemidler er der set allergi over for hydrocortison.
English: - due for an operation.
Danish: - hvis han/hun skal opereres.
English: Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol.
Danish: Hydrocortison kan anvendes under graviditet og amning, når kroppen ikke producerer nok kortisol.
English: Capsule Hypromellose
Danish: Kapsel Hypromellose
English: No studies have been conducted in patients with hepatic or renal impairment.
Danish: Der er ikke gennemført studier hos patienter med nedsat lever- eller nyrefunktion.
English: Excretion of granules
Danish: Udskillelse af granulat
English: Gastritis Nausea
Danish: Gastritis Kvalme
English: Alkindi has no or negligible influence on the ability to drive and use machines.
Danish: Alkindi påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Changing from conventional oral glucocorticoid treatment to Alkindi When changing patients from conventional oral hydrocortisone replacement therapy to Alkindi, an identical total daily dose may be given.
Danish: Skift fra konventionel oral glucocorticoidbehandling til Alkindi Når patienter skifter fra konventionel oral hydrocortison-erstatningsterapi til Alkindi, kan der gives en tilsvarende samlet daglig dosis.
English: Pharmacotherapeutic group: Corticosteroids for systemic use; Glucocorticoids.
Danish: Farmakoterapeutisk gruppe: Corticosteroider til systemisk brug, glucocorticoider.
English: Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Danish: Patienter/omsorgspersoner bør desuden være opmærksomme på psykiske forstyrrelser, der eventuelt kan optræde enten under eller umiddelbart efter dosisnedtrapning/seponering af systemiske steroider, selvom sådanne bivirkninger ikke er indberettet ofte.
English: Alkindi is therapeutically equivalent to conventional hydrocortisone tablets.
Danish: Alkindi svarer terapeutisk til konventionelle hydrocortisontabletter.
English: Long-term treatment with hydrocortisone may be associated with changes in the development of bones and reduced growth.
Danish: Langtidsbehandling med hydrocortison kan være forbundet med ændret knogleudvikling og reduceret vækst.
English: Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
Danish: Corticosteroider som erstatningsterapi hos personer med binyreinsufficiens medfører ikke immunsuppression, og administration af levende vacciner er derfor ikke kontraindiceret.
English: Of these 24 patients, 23 had a diagnosis of CAH and 1 had a diagnosis of hypopituitarism including hypothyroidism.
Danish: Af disse 24 patienter var 23 diagnosticeret med adrenogenitalt syndrom, og 1 var diagnosticeret med hypopituitarisme, herunder hypotyreose.
English: Undesirable effects are therefore less likely when using corticosteroids as replacement therapy.
Danish: Bivirkninger er derfor mindre sandsynlige ved brug af corticosteroider som erstatningsterapi.
English: Hard capsule for opening, containing a single dose of granules.
Danish: Hård kapsel, der skal åbnes; indeholder en enkelt dosis granulat.
English: If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone.
Danish: Hvis dit barn kaster op eller er meget dårlig, kan han/hun have brug for en injektion med hydrocortison.
English: Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Danish: Patienter/omsorgspersoner bør tilskyndes til at søge læge ved foruroligende psykiske symptomer, navnlig ved mistanke om nedtrykthed eller selvmordstanker.
English: The lowest appropriate dose of steroid according to the response of the individual patient should be used.
Danish: Den lavest effektive dosis steroid, som giver respons hos den enkelte patient, skal anvendes.
English: Hydrocortisone is a glucocorticoid.
Danish: Hydrocortison er et glucocorticoid.
English: This is because the centre of the granule is not absorbed in the gut after it has released the medicine.
Danish: Det skyldes, at granulatets midte ikke absorberes i tarmen, når det har frigivet lægemidlet.
English: MedDRA system organ class
Danish: MedDRAs systemorganklasse
English: - If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis barnet er allergisk over for hydrocortison eller et af de øvrige indholdsstoffer i Alkindi (angivet i punkt 6).
English: Microcrystalline cellulose Hypromellose Magnesium stearate Ethyl cellulose
Danish: Mikrokrystallinsk cellulose Hypromellose Magnesiumstearat Ethylcellulose
English: Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10-15 mg/m2/day in patients with congenital adrenal hyperplasia (CAH), typically in three or four divided doses.
Danish: Den anbefalede dosis hydrocortison ved erstatningsterapi er 8-10 mg/m2/dag for patienter med binyreinsufficiens alene og 10-15 mg/m2/dag hos patienter med adrenogenitalt syndrom, typisk fordelt på tre eller fire doser.
English: The granules may sometimes be seen in stools since the centre of the granule is not absorbed in the gut after it has released the active substance.
Danish: Indimellem kan der ses granulat i afføringen, da granulatets midte ikke absorberes i tarmen, når det har frigivet det aktive stof.
English: Your endocrinologist will train you how to do this in an emergency.
Danish: Speciallægen vil instruere dig i, hvordan dette gøres i en nødsituation.
English: Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi.
Danish: Så snart den tilstødende sygdom er ovre, kan patienterne vende tilbage til den normale dosis Alkindi som erstatningsterapi.
English: The granules should be given into the mouth and should not be chewed.
Danish: Granulatet skal gives gennem munden og må ikke tygges.