FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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).
English: Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis.
Danish: Hvis parenteral hydrocortison er påkrævet, skal patienten behandles på en klinik med genoplivningsudstyr i tilfælde af Addison krise.
English: - Contact your endocrinologist if your child experiences blurred vision or other visual disturbances.
Danish: - Kontakt speciallægen, hvis dit barn oplever sløret syn eller andre synsforstyrrelser.
English: overexcitement and overactivity (mania).
Danish: overbegejstring og hyperaktivitet (mani).
English: The study used a single dose of Alkindi granules equivalent to the previous morning's dose of each patient's usual glucocorticoid treatment.
Danish: I undersøgelsen blev der givet en enkeltdosis Alkindi granulat svarende til den enkelte patients sædvanlige morgendosis glucocorticoid.
English: Your endocrinologist will monitor your child's potassium levels to check for any changes.
Danish: Speciallægen vil overvåge barnets kaliumniveau for at tjekke for ændringer.
English: Alkindi has no influence on a child's ability to perform skilled tasks (e.g. riding a bicycle) or using machines.
Danish: Alkindi har ingen indvirkning på dit barns evne til at udføre opmærksomhedskrævende opgaver (f.eks. ridning eller cykling) eller betjene maskiner.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis dit barn får bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Fertility There are no data available for possible effects of Alkindi on fertility.
Danish: Fertilitet Der foreligger ingen data om Alkindis mulige virkning på fertiliteten.
English: 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.
Danish: 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.
English: Medicines called barbiturates, which can be used to treat convulsions (including phenobarbital and primidone).
Danish: Såkaldte barbiturater, der kan anvendes til behandling af krampeanfald (f.eks. phenobarbital og primidon).
English: 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.
Danish: Hos børn, der kan spise blød mad, kan granulatet kommes på en skefuld kold eller stuevarm yoghurt, frugtmos eller lignende og gives direkte.
English: 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.
Danish: 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.
English: Dosage must be individualised according to the response of the individual patient.
Danish: Dosis skal tilpasses individuelt efter patientens respons på behandlingen.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: Adrenal crisis
Danish: Addison krise
English: Infection should not be more likely at a replacement dose of hydrocortisone, but all infections should be treated seriously and stress dosing of steroid initiated early (see section 4.2).
Danish: Der er formodentlig ikke større sandsynlighed for infektion ved indgivelse af hydrocortison som erstatningsterapi, men alle infektioner bør tages alvorligt, og steroidbehandling i dosering som ved stresspåvirkning bør påbegyndes tidligt (se pkt.
English: Replacement therapy in primary and secondary adrenal insufficiency Alkindi is given as replacement therapy by oral administration of granules according to clinical practice, in a dose to be titrated against individual clinical response.
Danish: Erstatningsterapi ved primær og sekundær binyreinsufficiens Alkindi gives som erstatningsterapi ved oral administration af granulat i henhold til klinisk praksis i en dosis, der skal titreres i forhold til den individuelle kliniske respons på behandlingen.
English: Following oral administration, hydrocortisone is rapidly absorbed from the gastro-intestinal tract and the oral Alkindi 4x5 mg was approximately 87 % bioavailable when compared to intravenous hydrocortisone in dexamethasone-suppressed healthy adult male volunteers.
Danish: Efter oral administration absorberes hydrocortison hurtigt fra mave-tarm-kanalen, og oralt Alkindi 4x5 mg var ca. 87 % biotilgængeligt sammenholdt med intravenøst hydrocortison hos dexamethasonsupprimerede raske voksne mandlige frivillige.
English: White to off-white granules which are contained in a transparent colourless hard capsule for opening; the strength is printed on the capsule.
Danish: Hvidt til offwhite granulat, der er indeholdt i en gennemsigtig, farveløs hård kapsel, der skal åbnes; styrken er påtrykt kapslen.
English: Do not swallow the capsule, risk of choking.
Danish: Kapslerne må ikke synkes - risiko for kvælning.
English: The pivotal study was an open-label single-dose single-centre trial in 24 paediatric patients aged less than 6 years requiring replacement therapy for adrenal insufficiency due to CAH, primary adrenal failure or hypopituitarism.
Danish: Hovedundersøgelsen var et åbet enkeltdosis-studie udført på ét center, der omfattede 24 pædiatriske patienter under 6 år med behov for erstatningsterapi på grund af nyreinsufficiens ved adrenogenitalt syndrom, primært binyresvigt eller hypopituitarisme.
English: Once the bottle has been opened, use the capsules within 60 days.
Danish: Efter åbning af beholderen skal kapslerne anvendes inden for 60 dage.
English: If you stop giving Alkindi
Danish: Hvis du holder op med at give Alkindi
English: Hydrocortisone is a synthetic version of the hormone cortisol.
Danish: Hydrocortison er en syntetisk version af hormonet kortisol.
English: Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intrauterine growth retardation and effects on brain growth and development.
Danish: Administration af corticosteroider til drægtige dyr kan forårsage anomalier i fosterets udvikling, herunder ganespalte, intrauterin vækstretardering og påvirkning af hjernens vækst og udvikling.
English: Hydrocortisone belongs to a group of medicines known as corticosteroids.
Danish: Hydrocortison tilhører en gruppe lægemidler, der kaldes kortikosteroider.
English: Medicines used to treat AIDS: efavirenz and nevirapine.
Danish: Lægemidler til behandling af aids: efavirenz og nevirapin.
English: If you give your child more Alkindi than you should, contact your endocrinologist or pharmacist for further advice as soon as possible.
Danish: Hvis du har givet dit barn for meget Alkindi, skal du kontakte speciallægen eller apotekspersonalet og få yderligere vejledning så hurtigt som muligt.
English: - Whichever method is used, the capsule is tapped to ensure all the granules are removed.
Danish: - Uanset metode skal der bankes forsigtigt på kapslen for at sikre, at alt granulatet kommer med.
English: You should not stop giving Alkindi without the advice of your endocrinologist as this could make your child seriously unwell very quickly.
Danish: Du må ikke holde op med at give dit barn Alkindi uden at rådføre dig med speciallægen, da det kan gøre ham/hende alvorligt syg meget hurtigt.
English: During illnesses, at times of surgical operations and during times of serious stress, your endocrinologist may recommend additional doses of Alkindi and may also advise that your child receives other forms of hydrocortisone instead of, or as well as, Alkindi.
Danish: Ved sygdom, kirurgiske indgreb og alvorlig stress kan speciallægen anbefale, at der indgives yderligere doser Alkindi, og at dit barn får andre former for hydrocortison i stedet for eller som supplement til Alkindi.
English: Sudden discontinuation of therapy with Alkindi risks triggering an adrenal crisis and death.
Danish: Pludselig seponering af behandlingen med Alkindi kan udløse Addison krise og dødsfald.
English: Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement.
Danish: Voldsom vægtøgning med nedsat højdevæksthastighed eller andre symptomer eller tegn på Cushings syndrom er et tegn på, at dosen af glucocorticoid som erstatningsterapi er for stor.
English: The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
Danish: Den videnskabelige litteratur beskriver nedenstående bivirkninger hos voksne patienter ved brug af andre lægemidler med hydrocortison givet som erstatningsterapi ved nyreinsufficiens med hyppigheden ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Pack sizes: 1 bottle containing 50 capsules
Danish: Pakningsstørrelser: 1 beholder med 50 kapsler
English: Medicinal product-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage.
Danish: Lægemiddel induceret sekundær binyrebarkinsufficiens kan opstå ved for hurtig seponering af corticosteroider og minimeres ved gradvis nedtrapning af dosen.
English: - Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine - Antibiotics: rifampicin and rifabutin - Barbiturates including phenobarbital and primidone - Antiretroviral medicinal products: efavirenz and nevirapine
Danish: - Krampestillende midler: phenytoin, carbamazepin og oxcarbazepin - Antibiotika: rifampicin og rifabutin - Barbiturater, herunder phenobarbital og primidon - Antiretrovirale lægemidler: efavirenz og nevirapin
English: 0.5 mg (red)
Danish: 0,5 mg (rød)
English: Your endocrinologist will decide on the right dose of Alkindi based on your child's weight or size (body surface area) and then adjust the dose of Alkindi as your child grows.
Danish: Speciallægen vil fastsætte den rette dosis Alkindi ud fra dit barns vægt eller størrelse (legemsoverflade) og derefter justere dosen, efterhånden som barnet vokser.
English: Studies in animals have shown reproductive toxicity of corticosteroids (see section 5.3)
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved brug af corticosteroider (se pkt.
English: 1 mg (blue)
Danish: 1 mg (blå)
English: - If your child has any reaction like swelling or shortness of breath after being given Alkindi, get medical help straight away and tell your endocrinologist as soon as possible as these can be signs of an allergic reaction (see section 2).
Danish: - Hvis dit barn får en reaktion som f.eks. hævelse eller åndenød efter indgivelse af Alkindi, skal du søge lægehjælp med det samme og underrette speciallægen så hurtigt som muligt, da dette kan være tegn på en allergisk reaktion (se pkt.
English: Granules in capsules for opening.
Danish: Granulat i kapsler, der skal åbnes.
English: Contents of the pack and other information What Alkindi contains
Danish: Pakningsstørrelser og yderligere oplysninger Alkindi indeholder:
English: - The active substance is hydrocortisone - Alkindi 0.5 mg granules in capsules for opening: each capsule contains 0.5 mg of hydrocortisone - Alkindi 1 mg granules in capsules for opening: each capsule contains 1 mg of hydrocortisone - Alkindi 2 mg granules in capsules for opening: each capsule contains 2 mg of hydrocortisone - Alkindi 5 mg granules in capsules for opening: each capsule contains 5 mg of hydrocortisone - The other ingredients are microcrystalline cellulose, hypromellose, magnesium stearate and ethyl cellulose.
Danish: - Aktivt stof: hydrocortison - Alkindi 0,5 mg granulat i kapsler, der skal åbnes: En kapsel indeholder 0,5 mg hydrocortison - Alkindi 1 mg granulat i kapsler, der skal åbnes: En kapsel indeholder 1 mg hydrocortison - Alkindi 2 mg granulat i kapsler, der skal åbnes: En kapsel indeholder 2 mg hydrocortison - Alkindi 5 mg granulat i kapsler, der skal åbnes: En kapsel indeholder 5 mg hydrocortison - De andre ingredienser er mikrokrystallinsk cellulose, hypromellose, magnesiumstearat og ethylcellulose.
English: Patients/and or carers should be warned that potentially severe psychiatric adverse reactions; euphoria, mania, psychosis with hallucinations and delirium have been seen in adult patients at replacement doses of hydrocortisone (see section 4.8).
Danish: Patienter og/eller omsorgspersoner bør advares om de potentielt svære psykiatriske bivirkninger eufori, mani, psykose med hallucinationer og delirium, som er set hos voksne patienter ved indgivelse af hydrocortison som erstatningsterapi (se pkt.
English: Parenteral 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.
Danish: Parenteral administration af hydrocortison er indiceret ved forbigående sygdomstilstande som f.eks. svære infektioner, herunder navnlig gastroenteritis med opkastning og/eller diarré, høj feber uanset årsag eller voldsom fysisk stress ved f.eks. alvorlige uheld eller kirurgi under fuld narkose.
English: Naturally-occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
Danish: Naturligt forekommende glucocorticoider (hydrocortison og cortison), som også har saltretinerende egenskaber, anvendes som erstatningsterapi ved binyreinsufficiens.
English: Medicines that may mean your endocrinologist will increase your child's dose of Alkindi include: Medicines used to treat epilepsy: phenytoin, carbamazepine, and oxcarbazepine.
Danish: Lægemidler, der kan medføre, at speciallægen vil øge dit barns dosis af Alkindi, omfatter: Lægemidler til behandling af epilepsi: phenytoin, carbamazepin og oxcarbazepin.
English: - Anti-fungals: itraconazole, posaconazole, voriconazole - Antibiotics: erythromycin and clarithromycin - Antiretroviral medicinal products: ritonavir - Grapefruit juice
Danish: - Svampemidler: itraconazol, posaconazol, voriconazol - Antibiotika: erythromycin og clarithromycin - Antiretrovirale lægemidler: ritonavir - Grapefrugtjuice - Lakrids
English: Alkindi granules can sometimes appear in a child's nappy or poo after taking Alkindi.
Danish: Der kan indimellem ses noget Alkindi granult i en barneble eller i afføringen efter indtagelse af Alkindi.
English: Euphoria
Danish: Eufori
English: Other medicines and Alkindi
Danish: Brug af anden medicin sammen med Alkindi
English: Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early.
Danish: Hos patienter med binyreinsufficiens er der risiko for livstruende Addison krise under en infektion, så den kliniske opmærksomhed på infektion bør være skærpet, og man bør rådføre sig med en speciallæge hurtigt.
English: - Medicines used to treat infections (antibiotics): erythromycin and clarithromycin.
Danish: - Lægemidler til behandling af infektioner (antibiotika): erythromycin og clarithromycin.
English: Alkindi is used when the body is not making enough cortisol, because part of the adrenal gland is not working (adrenal insufficiency, often caused by an inherited condition called congenital adrenal hyperplasia).
Danish: Alkindi anvendes, når kroppen ikke producerer nok kortisol som følge af en forstyrrelse i binyrerne (binyresvigt, der ofte er forårsaget af en arvelig sygdom, som kaldes adrenogenitalt syndrom).
English: - Medicine used to treat human immunodeficiency virus (HIV) infection and AIDS: ritonavir.
Danish: - Lægemidler til behandling af humant immundefektvirus (hiv)-infektion og aids: ritonavir.
English: The granules must be given orally and should not be chewed.
Danish: Granulatet skal indgives peroralt og må ikke tygges.
English: The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets and Alkindi in dexamethasone-suppressed healthy adult male volunteers.
Danish: Den terminale halveringstid for hydrocortison er ca. 1,5 timer efter intravenøs og oral administration af hydrocortison tabletter og Alkindi hos dexamethason-supprimerede raske voksne mandlige ffrivillige.
English: All inks contain Shellac, Propylene glycol, Concentrated ammonia solution
Danish: Alt blæk indeholder Shellac, propylenglycol, koncentreret ammoniumopløsning
English: Tell your endocrinologist or pharmacist if your child becomes ill, suffers severe stress, gets injured or is about to have surgery because your endocrinologist may need to increase the dose of Alkindi in these circumstances (see section 2).
Danish: Sig det til speciallægen eller apotekspersonalet, hvis dit barn bliver syg, oplever alvorlig stress, kommer til skade eller skal opereres, da det kan være, at dosis af Alkindi skal øges i disse situationer (se pkt.
English: Bone mineral density may be impacted in children when higher doses of replacement steroids are used.
Danish: Knoglemineraltætheden kan blive påvirket hos børn ved højere doser steroider som erstatningsterapi.
English: Medicines used to treat infections (antibiotics): rifampicin and rifabutin.
Danish: Lægemidler til behandling af infektioner (antibiotika): rifampicin og rifabutin.
English: Always use this medicine exactly as your endocrinologist, nurse or pharmacist has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter speciallægens, sygeplejerskens eller apotekspersonalets anvisning.
English: - The top of the capsule is twisted off. - The granules are either poured directly onto the child's tongue, or the granules are poured onto a spoon and placed in the child's mouth.
Danish: - Granulatet kan enten hældes direkte på barnets tunge eller kommes på en ske, der puttes i munden på barnet.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy which have been reported after use of systemic and topical corticosteroids.
Danish: Ved symptomer som sløret syn eller andre synsforstyrrelser bør det overvejes at henvise patienten til oftalmolog til vurdering af de mulige årsager, der kan omfatte grå stær, glaukom eller sjældne sygdomme som f.eks. central serøs korioretinopati, som er indberettet efter brug af systemiske og topikale corticosteroider.
English: Talk to your endocrinologist or pharmacist before giving Alkindi if your child is:
Danish: Kontakt speciallægen eller apotekspersonalet, før du giver Alkindi til dit barn:
English: - The printing ink on the capsules contains shellac, propylene glycol, and concentrated ammonia solution.
Danish: - Blækket på kapslerne indeholder shellac, propylenglycol og koncentreret ammoniumopløsning.
English: Do not stop giving your child Alkindi without asking your endocrinologist first.
Danish: Du må ikke holde op med at give dit barn Alkindi uden at tale med speciallægen først.
English: Alkindi contains a medicine called hydrocortisone.
Danish: Alkindi indeholder et stof, der hedder hydrocortison.
English: Patients with dysphagia or premature infants where oral feeding has not been established.
Danish: Patienter med dysfagi eller for tidligt fødte børn, der endnu ikke får mad gennem munden.
English: Your endocrinologist will monitor your child's growth and bones (see section 2).
Danish: Speciallægen vil overvåge dit barns vækst og knogleudvikling (se pkt.
English: The granules must not be added to liquid as this can result in less than the full dose being given, and may affect the taste masking which will allow the bitter taste of hydrocortisone to become apparent.
Danish: Granulatet må ikke kommes i væske, da det kan mindske dosen og påvirke smagsmaskeringen, hvorved hydrocortisonets bitterhed kan smages.
English: Let your endocrinologist know if you are worried about your child's growth (see section 4).
Danish: Sig det til speciallægen, hvis du er bekymret for dit barns vækst (se pkt.
English: There is no information on any effects of Alkindi on fertility.
Danish: Der foreligger ingen data om mulig indvirkning af Alkindi på frugtbarheden.
English: If your child has a dramatic change in behaviour, contact your endocrinologist (see section 2).
Danish: Hvis dit barn udviser kraftig adfærdsændring, skal du kontakte speciallægen (se pkt.
English: Medicines that may mean your endocrinologist will decrease your child's dose of Alkindi include: - Medicines used to treat fungal diseases: itraconazole, posaconazole, and voriconazole.
Danish: Lægemidler, der kan medføre, at speciallægen vil nedsætte dit barns dosis af Alkindi, omfatter: - Svampemidler: itraconazol, posaconazol og voriconazol.
English: Medicinal products inducing CYP3A4, requiring a potential increase in Alkindi dosing, include but are not limited to:
Danish: Lægemidler, der er inducere af CYP3A4, og som kan nødvendiggøre en øgning af dosis af Alkindi, omfatter, men er ikke begrænset til:
English: due for a vaccination.
Danish: hvis han/hun skal vaccineres.
English: Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of allergies to medicinal products.
Danish: Sjældne tilfælde af anafylaktoide reaktioner er set hos patienter, der har fået corticosteroider, navnlig patienter med tidligere lægemiddelallergier.
English: Medicinal products/substances inhibiting CYP3A4, requiring a potential decrease in Alkindi dosing, include but are not limited to:
Danish: Lægemidler/stoffer, der er hæmmere af CYP3A4, og som kan nødvendiggøre en reduktion af dosis af Alkindi, omfatter, men er ikke begrænset til:
English: The capsules are provided in highdensity polyethylene bottles with polypropylene closure with integrated desiccant.
Danish: Kapslerne fås i beholdere af højdensitetspolyetylen med polypropylenlåg med integreret tørremiddel.
English: Let the anaesthetist know your child is receiving Alkindi before your child has their operation.
Danish: Fortæl narkoselægen, at dit barn får Alkindi, før han/hun skal opereres.