FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the patient is prescribed a different presentation, the prescriber should highlight to the patient the packaging differences between the different presentations (focus on colour differentiation, warning statements on carton, thickness and length of the provided syringe).
Danish: • Hvis patienten får ordineret forskellige pakninger, bør den ordinerende læge over for patienten fremhæve forskellene mellem de forskellige pakninger (fokus på farveforskellen, advarslerne på kartonen, tykkelsen og længden af den medfølgende sprøjte).
English: − in patients with porphyria;
Danish: − hos patienter med porfyri
English: Patients can be discharged when no longer requiring insulin treatment, when stable on a combination of AMGLIDIA and insulin or when stable on insulin alone.
Danish: Patienten kan udskrives, når der ikke længere behøves insulinbehandling, når patienten er stabil på en kombination af AMGLIDIA og insulin eller er stabil på insulin alene.
English: No interaction was observed when glibenclamide was taken at least 4 hours before colesevelam.
Danish: Der blev ikke set nogen interaktion, når glibenclamid blev indtaget mindst fire timer før colesevelam.
English: If ketone bodies are present, an insulin injection must be given rapidly to restore the metabolic situation.
Danish: Hvis ketonstoffer er tilstede, skal der hurtigt gives en injektion af insulin for at rette op på den metaboliske situation.
English: If ketonuria is detected, you must inject insulin immediately according to the procedure defined beforehand with your child's doctor and contact him/her or his/her team for advice.
Danish: Hvis der påvises ketonuri, skal du straks indsprøjte insulin efter den metode, du på forhånd har aftalt med dit barns læge, og kontakte lægen eller dennes kolleger for at få råd.
English: AMGLIDIA contains sodium and benzoate salt
Danish: AMGLIDIA indeholder natrium og benzoatsalt
English: If a dose is forgotten, there is a risk of hyperglycaemia.
Danish: Hvis en dosis glemmes, er der risiko for hyperglykæmi.
English: Pre-lunch or pre-evening meal glucose values fall more rapidly and are generally a better marker of response to AMGLIDIA.
Danish: Glukoseværdierne før frokost eller før aftensmåltidet falder hurtigere og er sædvanligvis en bedre markør for responsen på AMGLIDIA.
English: Note: if air gets into the syringe, empty the syringe into the bottle and start the procedure again.
Danish: Bemærk: Hvis der kommer luft ind i sprøjten, tømmes sprøjten ned i flasken, og proceduren gentages.
English: Two cases of severe hypoglycaemia were observed, which were considered related to the medicinal product.
Danish: Der blev iagttaget to tilfælde af svær hypoglykæmi, som blev anset for at have sammenhæng med lægemidlet.
English: If at the end of a 5 to 6-week period, there is no evidence of a response with insulin doses similar to those at starting, administration of doses up to 2 mg/kg/day for a week may be tried.
Danish: Hvis der i slutningen af en 5-6-ugers periode ikke er tegn på respons ved insulindoser svarende til initialdosis, kan administration af 2 mg/kg/dag i en uge forsøges.
English: For patients still under insulin at day 6, maintain the dose of AMGLIDIA for at least 4 weeks.
Danish: For patienter, som stadig får insulin på dag 6, skal dosis af AMGLIDIA fortsættes i mindst 4 uger.
English: AMGLIDIA with alcohol
Danish: Brug af AMGLIDIA sammen med alkohol
English: Patients must be closely monitored for at least 48 hours and, depending on the patient's condition at this time, the physician will decide if additional monitoring is necessary.
Danish: Patienterne skal overvåges tæt i mindst 48 timer, og lægen afgør derefter, om der er behov for yderligere overvågning, afhængigt af patientens tilstand på dette tidspunkt.
English: Long-acting sulphonamides
Danish: Langtidsvirkende sulfonamider
English: Nicotinic acid (in high doses)
Danish: Nicotinsyre (i høje doser)
English: Dosage adjustments and long-term management
Danish: Dosisjusteringer og langtidsbehandling
English: This must be followed by continuous infusion of more dilute glucose solution (10%) at the rate needed to maintain blood-glucose above 100 mg/dL (100 mg/dL = 5.5 mmol/L).
Danish: Dette skal efterfølges af kontinuerlig infusion af en mere fortyndet glukoseopløsning (10 %) med den hastighed, der er nødvendig for at holde blodglukose over 100 mg/dl (100 mg/dl = 5,5 mmol/l).
English: Disulfiram-like reactions have occurred very rarely following the concomitant use of alcohol and glibenclamide.
Danish: Disulfiram-lignende reaktioner er meget sjældent forekommet efter samtidig brug af alkohol og glibenclamid.
English: This was a phase II, single-centre, prospective, open-label, non-randomised study.
Danish: Studiet var et prospektivt, åbent, ikke randomiseret fase II-enkeltcenterstudie.
English: Blood-glucose level must be checked immediately and AMGLIDIA taken as soon as possible.
Danish: Blodglukose skal straks kontrolleres, og AMGLIDIA tages snarest muligt.
English: The nearest volume to the calculated one should be used.
Danish: Der bør anvendes det volumen, som er nærmest det beregnede.
English: If very low blood sugar occurs that affects consciousness, emergency services should be called and an intravenous glucose injection performed.
Danish: Hvis der opstår meget lavt blodsukker, som påvirker bevidstheden, skal der tilkaldes akuthjælp og der skal gives en intravenøs injektion af glukose.
English: Women of childbearing potential / Contraception
Danish: Kvinder i den fødedygtige alder/antikonception
English: In any other cases, AMGLIDIA 6 mg/mL should be preferred.
Danish: I alle andre tilfælde bør AMGLIDIA 6 mg/ml foretrækkes.
English: The elimination half-lives were similar for the two suspensions (almost 8 hours) and a little shorter than those observed with the crushed Daonil tablets.
Danish: Eliminationshalveringstiden var den samme for de to suspensioner (næsten 8 timer) og lidt kortere, end hvad der blev iagttaget med de knuste Daonil-tabletter.
English: Throughout the transfer period, administer bolus insulin or insulin pump boluses with meals as required to maintain reasonable glycemic control.
Danish: I hele overførselsperioden administreres bolusinsulin eller insulinpumpe-boluser sammen med et måltid som nødvendigt til opretholdelse af rimelig glykæmisk kontrol.
English: As shown in the literature and in the clinical studies performed with AMGLIDIA, the average daily dose is expected to be around 0.2 to 0.5 mg/kg/day in most of the patients suffering from neonatal diabetes.
Danish: Som det er påvist i litteraturen og i det kliniske studie, der blev udført med AMGLIDIA, forventes den gennemsnitlige daglige dosis at være ca. 0,2-0,5 mg/kg/dag hos de fleste af de patienter, som har neonatal diabetes.
English: − hypersensitivity to the active substance, other sulphonylureas or sulphonamides or to any of the excipients listed in section 6.1;
Danish: − overfølsomhed over for det aktive stof, andre sulfonylurinstoffer eller sulfonamider eller over for et eller flere af hjælpestofferne anført i punkt 6.1
English: Glibenclamide is strongly bound to plasma albumin (99%), which may account for certain drug interactions, but is not easily detached by acidic medicinal products.
Danish: Glibenclamid er stærkt bundet til plasmaalbumin (99 %), hvad der måske forklarer visse lægemiddelinteraktioner, men det frigøres ikke let af sure lægemidler.
English: Since no interaction study between glibenclamide and milk has been performed, and despite absence of food effect on glibenclamide absorption, recommendation is given to administer the suspension 15 minutes before child's milk feeding.
Danish: Da der ikke er foretaget nogen interaktionsundersøgelse mellem glibenclamid og mælk, anbefales det trods den manglende effekt af fødeindtagelse på absorptionen af glibenclamid at administrere suspensionen 15 minutter før, barnet får mælk.
English: Care should be taken when prescribing and administering AMGLIDIA to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL).
Danish: Der bør udvises forsigtighed ved ordination og administration af AMGLIDIA for at undgå doseringsfejl som følge af forveksling mellem milligram (mg) og milliliter (ml).
English: AMGLIDIA should not be used in patients with insulin-dependent type 1 diabetes mellitus with evidence of auto-immune destruction of beta cells.
Danish: AMGLIDIA bør ikke anvendes til patienter med insulinafhængig diabetes mellitus type 1 med tegn på autoimmun destruktion af β-celler.
English: Amglidia is not bioequivalent with (crushed) tablets containing the same amount of glibenclamide.
Danish: AMGLIDIA er ikke bioækvivalent med (knuste) tabletter, der indeholder den samme mængde glibenclamid.
English: − in patients with ketoacidosis, continuous intravenous insulin injection and intravenous infusion of physiologic saline remains the benchmark treatment.
Danish: − hos patienter med ketoacidose er kontinuerlig intravenøs insulininjektion og intravenøs infusion af fysiologisk saltvand fortsat standardbehandling
English: In pregnant women insulin is recommended for blood sugar control.
Danish: Til gravide kvinder anbefales insulin til blodsukkerregulering.
English: Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and are medical emergencies requiring immediate treatment as soon as the cause is diagnosed or suspected before immediately admitting the patient to hospital.
Danish: Svære hypoglykæmiske reaktioner med koma, krampeanfald eller andre neurologiske forstyrrelser er mulige og er akutte situationer, der kræver øjeblikkelig behandling, så snart årsagen er diagnosticeret eller formodet, før patienten straks indlægges.
English: Transfer to sulfonylureas occurred in childhood with a median [IQR] at transfer of 4.8 years [1.7 - 11.4 years].
Danish: Overførsel til sulfonylurinstoffer skete i barndommen med en median [IQR] ved overførsel på 4,8 år [1,7-11,4 år].
English: • Patients and/or their caretakers should be explained that: They are prescribed a dose of Amglidia in mL according to their body weight.
Danish: • Patienter og/eller deres omsorgspersoner skal have forklaret, at: dosis af Amglidia ordineres i ml i henhold til legemsvægten.
English: - This medicine has been prescribed for your child only.
Danish: - Lægen har ordineret dette lægemiddel til dit barn personligt.
English: Tell the doctor if you know that your child is affected by G6PD deficiency and contact him/her if you notice that your child is pale as compared to usually.
Danish: Sig det til lægen, hvis du ved, at dit barn har G6PD-mangel, og kontakt lægen, hvis du ser, at dit barn er blegere end normalt.
English: Draw back the plunger to obtain the desired volume (figure 4A).
Danish: Træk stemplet tilbage, så det ønskede volumen opnås (figur 4A).
English: Transitory increased transaminases
Danish: Forbigående forhøjede transaminaser
English: You should check capillary blood sugar of your child and follow the instructions described in section 4.
Danish: Du skal kontrollere sukkerindholdet i kapillærblod fra dit barn, og følge anvisningerne i afsnit 4.
English: Colesevelam used to lower cholesterol
Danish: Colesevelam, der anvendes til at sænke kolesterol
English: Pharmacotherapeutic group: Drugs used in diabetes, sulphonylureas, ATC code: A10BB01
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, sulfonylurinstoffer, ATC-kode: A10BB01
English: The symptoms of moderate hypoglycaemia, without loss of consciousness or neurological signs, must be completely corrected by taking sugar, adjusting the dose and/or changing dietary behaviour.
Danish: Symptomer på moderat hypoglykæmi, uden bevidsthedstab eller neurologiske tegn, skal korrigeres fuldstændigt ved sukkerindtagelse, dosisjustering og/eller kostændringer.
English: Seventy-five patients (93%) remained on sulphonylurea alone at most recent follow-up and 6/81(7%) were on sulphonylurea and daily insulin.
Danish: 75 patienter (93 %) fik fortsat sulfonylurinstof som monoterapi ved seneste opfølgning og 6/81 (7 %) var på sulfonylurinstof og daglig insulin.
English: • The choice of the Amglidia strength should be defined according to the prescribed posology and the patient's body weight.
Danish: • Styrken af Amglidia vælges i henhold til den ordinerede dosering og patientens legemsvægt.
English: Do not use any other syringe to administer AMGLIDIA.
Danish: Brug ikke nogen anden sprøjte til at indgive AMGLIDIA.
English: The same child had a transient and minimal ASAT 73 IU/L, and ALAT 42 IU/L increased (normal range below 60 and 40 respectively).
Danish: Samme barn havde forbigående minimalt forhøjet ASAT 73 IE/l, og ALAT 42 IE/l (normalområde mindre end hhv. 60 og 40).
English: Administering glibenclamide to a diabetic enhances the post-prandial insulinotropic response.
Danish: Administration af glibenclamid til en diabetiker styrker den postprandiale insulinotrope respons.
English: Neutropenia and transitory increased transaminases One child had punctually low leucocytes level, but close to the normal range (neutrophils 1.3×103/µL for a lower limit of normal of 1.5×103/µL).
Danish: Neutropeni og forbigående forhøjede transaminaser Ét barn fik tidsmæssigt sammenfaldende lavt leukocytniveau, der dog var tæt på normalområdet (neutrofiler 1,3 × 103/μl, hvor den nedre grænse af normalområdet er 1,5 × 103/μl).
English: A large international long-term term study of treatment for neonatal diabetes due to KCNJ11 mutations is ongoing and results were reported in 81 patients of the 90 patients originally included with a median [interquartile range] follow-up duration of 10.2 years [9.3-10.8 years].
Danish: Der pågår et stort internationalt, langsigtet studie af behandling af neonatal diabetes forårsaget af mutationer i KCNJ11, og resultater blev indberettet hos 81 patienter ud af de 90 patienter, som oprindeligt blev inkluderet med en median [interkvartilt interval] opfølgningsvarighed på 10,2 år [9,310,8 år].
English: Talk to your doctor before your child is given AMGLIDIA.
Danish: Kontakt lægen, før dit barn får AMGLIDIA.
English: You must talk to a doctor if your child does not feel better or if he/she feels worse after a few days.
Danish: Kontakt lægen, hvis dit barn får det værre eller ikke får det bedre i løbet af et par dage.
English: The oral syringe in the carton should be used only with this medicine.
Danish: Den orale sprøjte i æsken bør kun bruges med dette lægemiddel.
English: None of patients experienced deterioration in glycaemic control, defined as an increase of HbA1c by > 0.5% and exceeding 5.6% in patients with baseline HbA1c ≤ 5.6% or an increase of HbA1c by > 0.5% in patients with baseline HbA1c > 5.6%.
Danish: Ingen af patienterne fik forringet den glykæmiske kontrol, defineret som en stigning i HbA1c på >0,5 % til over 5,6 % hos patienter med baseline-HbA1c ≤5,6 %, eller en stigning i HbA1c på >0,5 % hos patienter med baseline-HbA1c >5,6 %.
English: G6PD is an enzyme evolved in sugar metabolism.
Danish: G6PD er et enzym, der er involveret i sukkerstofskiftet.
English: Remove the syringe from the adaptor.
Danish: Tag sprøjten ud af adapteren.
English: - Increase in sensitivity of the skin to sunlight.
Danish: - Øget lysfølsomhed af huden.
English: Bosentan used to treat high blood pressure in the blood vessels between the heart and the lungs.
Danish: Bosentan, der anvendes til behandling af for højt tryk i blodkarrene mellem hjertet og lungerne.
English: Medicines
Danish: Lægemidler
English: • Choice of the syringe to be used: After the total daily dose and the strength to be used have been defined, the frequency of the daily administration should be pointed out and the corresponding volume per administration should be calculated.
Danish: • Valg af sprøjte: Efter fastlæggelse af den samlede dagsdosis og den styrke, der skal anvendes, fastlægges hyppigheden af den daglige administration, og det tilsvarende volumen pr. administration beregnes.
English: Those not already mentioned above, which could happen in children as well are listed below.
Danish: Nedenfor er nævnt de bivirkninger, der ikke allerede er nævnt ovenfor, og som også kunne optræde hos børn.
English: In case of nausea glycaemia seems to be maintained and insulin does not need to be re-introduced until the patient is able to take the glibenclamide suspension.
Danish: Ved kvalme synes glykæmien at blive opretholdt, og der er ikke behov for genindførelse af insulin, før patienten er i stand til at få glibenclamid-suspensionen.
English: In a phase II, single-centre, prospective, open-label, non-randomised study, acceptability, efficiency and tolerance of the switch from crushed tablets to Amglidia suspension were measured.
Danish: I et prospektivt, åbent, ikke-randomiseret fase II-enkeltcenterstudie måltes acceptabilitet, effektivitet og tolerance af skift fra knuste tabletter til AMGLIDIA-suspension.
English: For first use
Danish: Ved første gangs brug
English: Increased toxicity of ciclosporin
Danish: Øget toksicitet af ciclosporin
English: Women of childbearing potential planning a pregnancy should be switched from oral glibenclamide to insulin.
Danish: Kvinder, der er i den fødedygtige alder og planlægger graviditet, bør skifte fra oralt glibenclamid til insulin.
English: Rifampicin used to treat infections including tuberculosis
Danish: Rifampicin, der anvendes til behandling af infektioner, herunder tuberkulose
English: However, close monitoring of blood-glucose is required in all cases (please also refer to recommendations given under the heading “dose omission” further below) and adequate measures to restore euglycemia (e. g. application of a third daily AMGLIDIA dose or insulin) must be taken.
Danish: Nøje overvågning af blodglukose er dog nødvendig i alle tilfælde (se også anbefalingerne under overskriften "udeladt dosis" nedenfor), og der bør træffes passende foranstaltninger til genopretning af euglykæmi (f.eks. anvendelse af en tredje daglig dosis AMGLIDIA, eller insulin).
English: The screw cap should then be replaced on the bottle with the adaptor and not removed during the 30-day use.
Danish: Skruelåget sættes derefter tilbage på flasken med adapteren og aftages ikke under de 30 dages anvendelse.
English: No interaction studies have been performed for the two oral suspensions of glibenclamide (0.6 mg/mL and 6 mg/mL).
Danish: Der ikke udført interaktionsstudier for de to orale glibenclamid-suspensioner (0,6 mg/ml og 6 mg/ml).
English: The conversion rate between micronised tablets and the suspension has not been established.
Danish: Der er ikke fastlagt et omregningsforhold mellem mikroniserede tabletter og suspensionen.
English: Postprandial responses involving secretion of insulin and peptide-C continue to be enhanced after at least 6 months of treatment and even over many years in the case of neonatal diabetes by potassium channel disorders.
Danish: Postprandiale reaktioner, der involverer udskillelse af insulin og C-peptid, er fortsat øget efter mindst 6 måneders behandling, endog gennem mange år, ved neonatal diabetes forårsaget af kaliumkanalforstyrrelser.
English: Glibenclamide crosses the placenta mostly in small amounts; however, transfer is highly variable among patients.
Danish: Glibenclamid passerer placenta i hovedsagelig små mængder, der dog varierer stærkt mellem patienterne.
English: See your doctor, nurse or your hospital pharmacist immediately.
Danish: Kontakt straks lægen, sygeplejersken eller hospitalsfarmaceuten.
English: Anaphylactic reaction including dyspnoea, hypotension and shock.
Danish: Immunsystemet Anafylaktiske reaktioner, herunder dyspnø, hypotension og shock.
English: The Prescriber's Guide shall contain the following key messages:
Danish: Ordinationsvejledningen skal indeholde følgende hovedpunkter:
English: A summary of the interactions detailed above and further interactions are summarised in the table below.
Danish: Tabellen nedenfor viser en sammenfatning af ovenstående interaktioner og yderligere interaktioner.
English: This medicinal product contains 2.8 mg of sodium per mL oral suspension, equivalent to 0.1% of the WHO recommended daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 2,8 mg natrium pr. ml oral suspension, svarende til 0,1 % den af WHO anbefalede daglige indtagelse af 2 g natrium til en voksen.
English: The symptoms of hypoglycaemia may also be milder or absent where hypoglycaemia develops gradually or where there is autonomic neuropathy.
Danish: Symptomerne på hypoglykæmi kan også være lettere eller helt mangle, når hypoglykæmien udvikles gradvis, eller når der er autonom neuropati.
English: Glibenclamide may increase the risk of low blood sugar and therefore have a moderate influence on the ability to drive, to take part in road traffic otherwise or use machines.
Danish: Glibenclamid kan øge risikoen for lavt blodsukker og kan derfor have moderat indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Transitory diarrhea, vomiting and abdominal pain and dyspepsia Two children had abdominal pain (one with transient diarrhea and vomiting during the same episode) that were considered related to the medicinal product.
Danish: Forbigående diarré, opkastning og abdominalsmerter og dyspepsi To børn fik abdominalsmerter (det ene med forbigående diarré og opkastning i samme episode), som blev anset for at have sammenhæng med lægemidlet.
English: Quinolone antibiotics
Danish: Antibiotika af quinolontypen
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Oxypentifylline used to improve peripheral blood flow
Danish: Oxypentifyllin, der anvendes til at forbedre den perifere blodgennemstrømning
English: Sometimes, blood-glucose concentration will fall even though the patient is on a fixed dose of AMGLIDIA.
Danish: Blodglukosekoncentrationen falder undertiden, selvom patienten får en fast dosis af AMGLIDIA.
English: The exposures were respectively similar for the two glibenclamide oral suspensions, and greater than those observed after administration of crushed Daonil tablets.
Danish: Eksponeringerne var ens for de to orale glibenclamid-suspensioner og større end dem, der blev observeret efter administration af knuste Daonil-tabletter.
English: AMGLIDIA has moderate influence on the ability to drive and use machines since glibenclamide may increase the risk of hypoglycaemia.
Danish: AMGLIDIA påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner, da glibenclamid kan øge risikoen for hypoglykæmi.
English: Therefore, glibenclamide should be administered at least 4 hours prior to colesevelam.
Danish: Glibenclamid bør derfor administreres mindst fire timer før colesevelam.
English: If you notice any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: The syringe must be rinsed thoroughly with water, wiped dry after each use and replaced back into the medicine's carton.
Danish: Efter hver gangs brug skal sprøjten skylles grundigt med vand, tørres af og lægges tilbage i lægemidlets æske.
English: If vomiting occurs more than 30 minutes following administration of AMGLIDIA, no new dose should be given.
Danish: Hvis opkastning finder sted mere end 30 minutter efter indgift af AMGLIDIA, skal der ikke gives en ny dosis.
English: The educational material is aimed at increasing awareness about the four presentations available (two strengths of the product, each containing either a 1mL or a 5mL syringe) and at minimising the risk of hypoglycaemia in case of mix-ups of the different presentations.
Danish: Informationsmaterialet tager sigte på at øge bevidstheden om de fire tilgængelige pakninger (to styrker af produktet, hver indeholdende enten en 1 ml- eller en 5 ml-sprøjte) og på at minimere risikoen for hypoglykæmi ved sammenblanding af de forskellige pakninger.