natgillin/translations-raw huggingface dataset:
COX-2 findes i høje koncentrationer i adenomatøse polypper i tyktarmen og endetarmen. 
COX-2 is found at high levels in adenomatous colorectal polyps.
Den fuldstændige liste over begrænsningerne fremgår af indlægssedlen. 
For the full list of restrictions, see the
Onsenal nedsatte også antallet af polypper hos patienter i alderen 10 til 14 år med FAP. 
Onsenal also reduced the number of polyps in patients aged 10 to 14
Patienter, hvis krop nedbryder Onsenal langsomt, skal muligvis have en lavere startdosis. 
A lower starting dose may be needed in patients whose bodies may break Onsenal down slowly.
Hvordan virker Onsenal? 
How does Onsenal work?
Den fuldstændige liste over de indberettede bivirkninger ved Onsenal fremgår af indlægssedlen. 
For the full list of all side effects reported with Onsenal, see the
Hvilken fordel viser undersøgelserne, at der er ved Onsenal? 
What benefit has Onsenal shown during the studies?
Det fås som hvide kapsler (200 og 400 mg). 
It is available as white capsules
Den normale behandling af FAP-patienter skal fortsættes. 
The usual medical care for FAP
Hyppighed: ikke kendt 
Frequency: not known
Efter første åbning: 60 dage. 
After first opening: 60 days.
Dato for første markedsføringstilladelse: 09. februar 2018 
Date of first authorisation: 09 February 2018
Hvis dit barn får det dårligt 
If your child becomes unwell
Styrke (blækfarve) Indeholder også: 
Strength (ink colour) Also contains:
Den lavest mulige dosis bør anvendes. 
The lowest possible dosage should be used.
68,8 % af de raske voksne forsøgspersoner har beskrevet smagen som neutral. 
68.8% of healthy adult volunteers have described the taste as neutral.
ATC-kode: H02AB09 
ATC code: H02AB09
Desuden modificerer de kroppens immunrespons på diverse stimuli. 
In addition they modify the body's immune responses to diverse stimuli.
Infektioner og immunisering 
Infections and immunisation
Brug af Alkindi sammen med mad og drikke 
Alkindi with food and drink
50 kapsler 
50 capsules
Disse omfatter: - Grapefrugtjuice - Lakrids 
These include: - Grapefruit juice.
Spædbørn kræver hyppig evaluering og bør kontrolleres mindst hver 3.-4. måned til vurdering af vækst, blodtryk og almentilstand. 
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.
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. 
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.
Tlf. +31 (0)20 6615 072 info@diurnal.co.uk 
Tel. +31 (0)20 6615 072 info@diurnal.co.uk
Symptomerne ses typisk få dage eller uger efter påbegyndelse af behandlingen. 
Symptoms typically emerge within a few days or weeks of starting the treatment.
Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger. 
Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.
Behov for dosisjustering ved brug af sådanne lægemidler kan forventes, og patienterne bør overvåges nøje. 
The need for dose adjustment when such medicinal products are used can be anticipated and patients should be closely monitored.
intens følelse af lykke og opstemthed (eufori). 
intense feeling of happiness and excitement (euphoria).
Bindingen sker ved to proteinfraktioner. 
The binding is accounted for by two protein fractions.
De anvendes desuden på grund af deres potente antiinflammatoriske effekt ved lidelser i mange organsystemer. 
They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Psykose med hallucinationer og delirium Mani 
Psychosis with hallucinations and delirium Mania
Den biologiske halveringstid for hydrocortison er ca. 100 minutter. 
The biological half-life of hydrocortisone is about 100 minutes.
Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 Frankrig 
Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 France
Ved stresspåvirkning kan det være nødvendigt at øge dosis midlertidigt. 
During stress it may be necessary to increase the dose temporarily.
Der sås ingen bivirkninger eller episoder med Addison krise i nogen af studierne. 
There were no adverse reactions and no episodes of adrenal crisis seen in any of the studies.
Da Alkindi erstatter det naturlige hormon, som dit barn mangler, er bivirkninger ualmindelige; men: 
As Alkindi is replacing the normal hormone your child lacks, side effects are uncommon, however:
Da der var tale om et enkeltdosis-studie, var det primære effektmål cortisol-niveauet i serum efter 60 minutter. 
As this was a single-dose study, the primary efficacy assessment was serum cortisol at 60 minutes.
6 ud af 12 børn i kohorte 1 (i alderen 2,6-4,7 år) besvarede et justeret spørgeskema vedrørende smagen. 
Six of the 12 children in Cohort 1 (age range 2.6 to 4.7 years) responded to an adjusted palatability questionnaire.
Ved pludseligt ophør med medicinen kan barnet hurtigt få det meget dårligt. 
Stopping the medicine suddenly could quickly make your child very unwell.
Van Heuven Goedhartlaan 935 A 1181LD Amstelveen Holland 
Van Heuven Goedhartlaan 935 A 1181LD Amstelveen The Netherlands
Behandling med Alkindi bør ikke forhindre dit barn i at blive vaccineret. 
Taking Alkindi should not stop your child being vaccinated.
Fordeling 90 % eller derover af cirkulerende hydrocortison er reversibelt bundet til protein. 
Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein.
Kapselskallen må ikke sluges, men skal åbnes forsigtigt på følgende måde: 
The capsule shell must not be swallowed but carefully be opened as follows:
- 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. 
- If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth.
- Kapslen er fremstillet af hypromellose. 
- The capsule is made from hypromellose.
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. 
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.
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. 
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.
1 patient havde nyrehypoplasi, 1 patient havde atopisk dermatitis, og 1 patient havde rhinitis. 
1 patient had renal hypoplasia, 1 patient atopic dermatitis and 1 patient had rhinitis.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i appendiks V. 
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Hydrocortison metaboliseres via cytokrom P450 3A4 (CYP3A4). 
Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4).
I alvorlige situationer kræves en øjeblikkelig dosisøgning, og oral administration af hydrocortison skal erstattes med parenteral behandling. 
In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Administration af Alkindi sammen med blød mad (yoghurt eller frugtmos) er undersøgt in vitro, hvor der ikke er set nogen signifikant effekt på opløsning. 
The coadministration of Alkindi with soft food (yoghurt and fruit puree) has been studied in vitro with no significant effect on dissolution seen.
Hver æske indeholder 1 beholder. 
Each carton contains 1 bottle.
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). 
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).
hvis han/hun har det dårligt eller har en infektion. 
unwell or has an infection.
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. 
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.
Lige efter administrationen skal barnet have noget at drikke, f.eks. vand, mælk, brystmælk eller modermælkserstatning, for at sikre, at alt granulatet synkes. 
Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.
≥ 50 % af patienterne svarede 'meget god' til smagen, fornemmelsen i munden og synkeligheden, og at de sandsynligvis ville tage lægemidlet igen. 
≥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.
Glucocorticoider giver omfattende og forskelligartede metaboliske virkninger. 
Glucocorticoids cause profound and varied metabolic effects.
De fleste bivirkninger svinder efter dosisreduktion eller seponering, men specifik behandling kan være nødvendig. 
Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
- Nogle voksne patienter i behandling med hydrocortison (svarende til Alkindi) har oplevet angst, depression eller forvirring. 
- Some adult patients taking hydrocortisone (similar to Alkindi) became anxious, depressed or confused.
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. 
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.
- Ændringer i blodets kaliumniveau, der kan føre til forhøjet alkalinitet i kropsvæv eller kropsvæsker (hypokaliæmisk alkalose). 
- Changes in blood potassium levels, leading to excessive alkalinity of body tissues or fluids (hypokalaemic alkalosis).
Hypokaliæmisk alkalose 
Hypokalaemic alkalosis
Erstatningsterapi ved binyreinsufficiens hos spædbørn, børn og unge (fra 0 til <18 år). 
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
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. 
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.
Den ene proteinfraktion, corticosteroid-bindende globulin, er et glykoprotein; den anden proteinfraktion er albumin. 
One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.
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. 
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.
Detaljerede piktogrammer, som illustrerer, hvordan granulatet skal administreres, fremgår af indlægssedlen. 
Detailed pictograms on how to administer the granules are provided in the package leaflet.
Alkindi blev vurderet positivt, hvad smagen angår. 
Alkindi was positively assessed in terms of palatability.
Granulatet er hvidt til offwhite og er indeholdt i en gennemsigtig, farveløs hård kapsel (størrelse 00el). 
The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule.
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. 
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.
- Hos nogle patienter med allergier over for andre lægemidler er der set allergi over for hydrocortison. 
- In some patients with allergies to other medicines, allergy to hydrocortisone has been seen.
- hvis han/hun skal opereres. 
- due for an operation.
Hydrocortison kan anvendes under graviditet og amning, når kroppen ikke producerer nok kortisol. 
Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol.
Kapsel Hypromellose 
Capsule Hypromellose
Der er ikke gennemført studier hos patienter med nedsat lever- eller nyrefunktion. 
No studies have been conducted in patients with hepatic or renal impairment.
Udskillelse af granulat 
Excretion of granules
Gastritis Kvalme 
Gastritis Nausea
Alkindi påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Alkindi has no or negligible influence on the ability to drive and use machines.
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. 
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.
Farmakoterapeutisk gruppe: Corticosteroider til systemisk brug, glucocorticoider. 
Pharmacotherapeutic group: Corticosteroids for systemic use; Glucocorticoids.
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. 
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.
Alkindi svarer terapeutisk til konventionelle hydrocortisontabletter. 
Alkindi is therapeutically equivalent to conventional hydrocortisone tablets.
Langtidsbehandling med hydrocortison kan være forbundet med ændret knogleudvikling og reduceret vækst. 
Long-term treatment with hydrocortisone may be associated with changes in the development of bones and reduced growth.
Corticosteroider som erstatningsterapi hos personer med binyreinsufficiens medfører ikke immunsuppression, og administration af levende vacciner er derfor ikke kontraindiceret. 
Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
Af disse 24 patienter var 23 diagnosticeret med adrenogenitalt syndrom, og 1 var diagnosticeret med hypopituitarisme, herunder hypotyreose. 
Of these 24 patients, 23 had a diagnosis of CAH and 1 had a diagnosis of hypopituitarism including hypothyroidism.
Bivirkninger er derfor mindre sandsynlige ved brug af corticosteroider som erstatningsterapi. 
Undesirable effects are therefore less likely when using corticosteroids as replacement therapy.
Hård kapsel, der skal åbnes; indeholder en enkelt dosis granulat. 
Hard capsule for opening, containing a single dose of granules.
Hvis dit barn kaster op eller er meget dårlig, kan han/hun have brug for en injektion med hydrocortison. 
If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone.
Patienter/omsorgspersoner bør tilskyndes til at søge læge ved foruroligende psykiske symptomer, navnlig ved mistanke om nedtrykthed eller selvmordstanker. 
Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Den lavest effektive dosis steroid, som giver respons hos den enkelte patient, skal anvendes. 
The lowest appropriate dose of steroid according to the response of the individual patient should be used.
Hydrocortison er et glucocorticoid. 
Hydrocortisone is a glucocorticoid.
Det skyldes, at granulatets midte ikke absorberes i tarmen, når det har frigivet lægemidlet. 
This is because the centre of the granule is not absorbed in the gut after it has released the medicine.
MedDRAs systemorganklasse 
MedDRA system organ class
- hvis barnet er allergisk over for hydrocortison eller et af de øvrige indholdsstoffer i Alkindi (angivet i punkt 6). 
- If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Mikrokrystallinsk cellulose Hypromellose Magnesiumstearat Ethylcellulose 
Microcrystalline cellulose Hypromellose Magnesium stearate Ethyl cellulose
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. 
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.
Indimellem kan der ses granulat i afføringen, da granulatets midte ikke absorberes i tarmen, når det har frigivet det aktive stof. 
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.
Speciallægen vil instruere dig i, hvordan dette gøres i en nødsituation. 
Your endocrinologist will train you how to do this in an emergency.
Så snart den tilstødende sygdom er ovre, kan patienterne vende tilbage til den normale dosis Alkindi som erstatningsterapi. 
Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi.
Granulatet skal gives gennem munden og må ikke tygges. 
The granules should be given into the mouth and should not be chewed.
Det er nødvendigt at overvåge den kliniske respons, og patienterne bør observeres tæt for tegn, der kan kræve dosisjustering, herunder ændringer i klinisk status ved remission eller forværring af sygdommen, individuel respons på lægemidlet og stresspåvirkning (f.eks. kirurgi, infektion, traume). 
Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma).
Hvis parenteral hydrocortison er påkrævet, skal patienten behandles på en klinik med genoplivningsudstyr i tilfælde af Addison krise. 
Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis.
- Kontakt speciallægen, hvis dit barn oplever sløret syn eller andre synsforstyrrelser. 
- Contact your endocrinologist if your child experiences blurred vision or other visual disturbances.
overbegejstring og hyperaktivitet (mani). 
overexcitement and overactivity (mania).
I undersøgelsen blev der givet en enkeltdosis Alkindi granulat svarende til den enkelte patients sædvanlige morgendosis glucocorticoid. 
The study used a single dose of Alkindi granules equivalent to the previous morning's dose of each patient's usual glucocorticoid treatment.
Speciallægen vil overvåge barnets kaliumniveau for at tjekke for ændringer. 
Your endocrinologist will monitor your child's potassium levels to check for any changes.
Alkindi har ingen indvirkning på dit barns evne til at udføre opmærksomhedskrævende opgaver (f.eks. ridning eller cykling) eller betjene maskiner. 
Alkindi has no influence on a child's ability to perform skilled tasks (e.g. riding a bicycle) or using machines.
Hvis dit barn får bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. 
If your child gets any side effects, talk to your doctor or pharmacist.
Fertilitet Der foreligger ingen data om Alkindis mulige virkning på fertiliteten. 
Fertility There are no data available for possible effects of Alkindi on fertility.
Samtidig administration af lægemidler, der er hæmmere eller inducere af CYP3A4, kan derfor føre til uønskede ændringer i serumkoncentrationen af Alkindi med risiko for bivirkninger, navnlig Addison krise. 
Concomitant administration of medicinal products that are inhibitors or inducers of CYP3A4 may therefore lead to unwanted alterations in serum concentrations of Alkindi with the risk of adverse effects, particularly adrenal crisis.
Såkaldte barbiturater, der kan anvendes til behandling af krampeanfald (f.eks. phenobarbital og primidon). 
Medicines called barbiturates, which can be used to treat convulsions (including phenobarbital and primidone).
Hos børn, der kan spise blød mad, kan granulatet kommes på en skefuld kold eller stuevarm yoghurt, frugtmos eller lignende og gives direkte. 
For children who are able to take soft food, the granules may be sprinkled onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and given immediately.
Hydrocortison metaboliseres i leveren og de fleste kropsvæv til hydrogenerede og nedbrudte former, herunder tetrahydrocortison og tetrahydrocortisol, der udskilles i urinen, primært konjugeret som glucuronider, sammen med en meget lille mængde uomdannet hydrocortison. 
Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
Dosis skal tilpasses individuelt efter patientens respons på behandlingen. 
Dosage must be individualised according to the response of the individual patient.
Den administrerede dosis af Alkindi lå på mellem 1 og 4 mg. Forældrene/omsorgspersonerne (og om muligt børnene) vurderede smagen af Alkindi efter indgivelsen ved brug af en Likert-skala med 5 trin. 
The Alkindi dose range administered was 1 mg - 4 mg. Parents/carers (and where possible children) assessed the palatability of Alkindi after administration using a 5-item Likert scale.
Det vides ikke, om dette kan ske hos børn og unge, men sig det til speciallægen, hvis dit barn udvikler usædvanlig adfærd efter behandlingsstart med Alkindi (se pkt. 
It is not known if this would happen with children, but tell your endocrinologist if your child develops any unusual behaviour after starting Alkindi (see section 4).
Addison krise 
Adrenal crisis