FrancophonIA/ELRC3.0 huggingface dataset:
English: One child had dyspepsia, which was considered related to the medicinal product.
Danish: Ét barn fik dyspepsi, som blev anset for at have sammenhæng med lægemidlet.
English: Reduction of AMGLIDIA dose should be anticipated by the treating physician and certainly if the glucose values are going below 4 mmol/L (72 mg/dL).
Danish: Reduktion of AMGLIDIA bør forudses af den behandlende læge og navnlig, hvis glukoseværdierne skal være under 4 mmol/l (72 mg/dl).
English: You should therefore never stop the medicine without checking with the doctor looking after your child. Seek advice from your doctor.
Danish: Du må derfor aldrig holde op med at give lægemidlet uden at aftale det med den læge, der har ansvaret for dit barn.
English: Adverse reactions reported with glibenclamide (oral suspension or crushed tablets) in children, in the frame of treatment of neonatal diabetes are listed below by system organ class and frequency grouping.
Danish: Bivirkninger rapporteret med glibenclamid (oral suspension eller knuste tabletter) hos børn ved behandling af neonatal diabetes er anført nedenfor for hver systemorganklasse og hyppighedsgruppe.
English: Blood-glucose should be monitored periodically throughout treatment with glibenclamide.
Danish: Blodglukose bør overvåges periodisk under hele behandlingen med glibenclamid.
English: Adverse reactions (diarrhoea/nausea/reduced appetite/abdominal pain) were reported in 10/81(12%); these were transient, and no patients discontinued sulphonylurea as a result.
Danish: Der blev indberettet om bivirkninger (diarré/kvalme/nedsat appetit/abdominalsmerter) hos 10/81 (12 %); disse var forbigående, og ingen patienter ophørte med sulfonylurinstof på grund heraf.
English: Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity.
Danish: Glibenclamid kan øge plasmakoncentrationen af ciclosporin og potentielt forårsage øget toksicitet af ciclosporin.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If your child's capillary blood sugar exceeds 3 g/L (or 300 mg/dL or 16.5 mmol/L), check for the presence of ketonuria with a finger stick or urine stick tests according to your child's doctor recommendations.
Danish: Hvis dit barns blodsukker er over 3 g/l (eller 300 mg/dl eller 16,5 mmol/l), skal du kontrollere, om der er ketonuri, med en fingerstick eller urinteststrimmel som anbefalet af dit barns læge.
English: To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day.
Danish: For at undgå overskridelse af den acceptable dagsdosis af natriumbenzoat bør dagsdosis af AMGLIDIA ikke overstige 1 ml/kg/dag.
English: The most frequent adverse reactions are hypoglycemia, transitory diarrhea and abdominal pain.
Danish: De hyppigste bivirkninger er hypoglykæmi, forbigående diarré og abdominalsmerter.
English: Published data from 11 glibenclamide-treated mothers indicate that glibenclamide is not excreted in human milk and hypoglycemia in the breast-fed newborns was not reported.
Danish: Publicerede data fra 11 mødre behandlet med glibenclamid tyder på, at glibenclamid ikke udskilles i modermælk, og der er ikke indberettet om hypoglykæmi hos nyfødte brystbørn.
English: If a hypoglycaemic coma is diagnosed or suspected, the patient should quickly receive an intravenous injection of concentrated glucose solution (0.5 g/kg body weight as a 30% glucose solution).
Danish: Ved diagnosticeret eller formodet hypoglykæmisk koma skal patienten hurtigt have en intravenøs injektion af koncentreret glukoseopløsning (0,5 g/kg legemsvægt som 30 % glukoseopløsning).
English: Always give the medicine before feeding,
Danish: Indgiv altid lægemidlet før et måltid.
English: The dose in mL per administration and the number of administrations per day have to carefully follow the medical prescription.
Danish: Dosis i ml pr. administration og antallet af administrationer pr. dag skal nøje følge ordinationen.
English: Population pharmacokinetic approach was used to compare steady state concentrations following 0.9 mg twice daily in children with body weights between 10 - 30 kg and 1.25 mg twice daily in adults.
Danish: Der blev anvendt en populationsfarmakokinetisk metode til sammenligning af steady statekoncentrationerne efter 0,9 mg to gange dagligt hos børn med legemsvægt mellem 10 og 30 kg, og 1,25 mg to gange dagligt hos voksne.
English: Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
Danish: Stigning i bilirubinæmi efter dets fortrængning fra albumin kan øge neonatal ikterus, som kan udvikle sig til kernikterus (aflejring af ukonjugeret bilirubin i hjernevæv).
English: The average dose reported in the literature (clinical trials and case reports) is of approximately 0.5 mg/kg/day.
Danish: Den gennemsnitlige dosis, der er rapporteret i litteraturen (kliniske forsøg og individuelle rapporter), er på ca. 0,5 mg/kg/d.
English: Neonatal diabetes is a disease where the child's body does not release enough insulin to control the level of blood sugar; AMGLIDIA is used only in patients who still have some ability to make insulin.
Danish: Neonatal diabetes er en sygdom, hvor barnets krop ikke frigiver tilstrækkeligt insulin til at kontrollere blodsukkeret; AMGLIDIA anvendes kun hos patienter, der stadig har nogen evne til at producere insulin.
English: Anabolic steroids and male sex hormones
Danish: Anabolske steroider og mandlige kønshormoner
English: Clarithromycin is an antibiotic used to treat certain infections
Danish: Clarithromycin, der er et antibiotikum, der anvendes til behandling af visse infektioner
English: Stimulation of insulin secretion by glibenclamide in response to a meal is of major significance.
Danish: Glibenclamids stimulation af insulinudskillelsen som respons på et måltid er af stor betydning.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs websted: http://www.ema.europa.eu.
English: When limited to clinical trials or prospective data collections only, the average dose decreases to 0.2 to 0.3 mg/kg/day.
Danish: Når der kun ses på kliniske forsøg eller prospektive dataindsamlinger falder den gennemsnitlige dosis til 0,2-0,3 mg/kg/dag.
English: Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANCE
Danish: Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANKRIG
English: Hypereosinophilia, leucopenia, mild or severe thrombocytopenia, which can lead to purpura.
Danish: Hypereosinofili, leukopeni, let eller svær trombocytopeni, som kan føre til purpura.
English: You should only use the syringe which has been prescribed by your doctor.
Danish: Du må kun bruge den sprøjte, lægen har ordineret.
English: • The prescription should state the calculated daily dose in mL, the strength of Amglidia to be used, the number of administrations over which the daily dose is divided, as well as the volume in mL to be administered for each dose and the size of the syringe to be used.
Danish: • Recepten skal angive den beregnede dagsdosis i ml, den styrke af Amglidia, der skal anvendes, antallet af administrationer, som dagsdosis skal fordeles på, samt mængden i ml, som skal administreres for hver dosis, og størrelsen af den sprøjte, der skal anvendes.
English: Patients with complications were older at age of transfer to sulfonylurea than those without complications (median age at transfer: 20.5 v 4.1 years, p=0.0005).
Danish: Patienter med komplikationer var ældre ved overførsel til sulfonylurinstof end patienter uden komplikationer (median alder ved overførsel hhv. 20,5 og 4,1 år, p = 0,0005).
English: Bioavailability studies have demonstrated that nonmicronised tablets provide serum glibenclamide concentrations that are not bioequivalent to those from micronised tablets.
Danish: Biotilgængelighedsundersøgelser har vist, at ikke-mikroniserede tabletter giver koncentrationer af glibenclamid i serum, som ikke er bioækvivalente med koncentrationer opnået med mikroniserede tabletter.
English: AMGLIDIA contains the active substance called glibenclamide which belongs to a group of medicines called sulphonylureas used for lowering blood sugar (blood-glucose).
Danish: AMGLIDIA indeholder det aktive stof glibenclamid, der tilhører lægemiddelgruppen sulfonylurinstoffer, som anvendes til at sænke blodsukkeret (blodglukose).
English: The most serious adverse reaction is hypoglycemia (see section 4.4).
Danish: Den alvorligste bivirkning er hypoglykæmi (se pkt.
English: The relative bioavailability was 121.6% for the 0.6 mg/mL suspension and 114.1% for the 6 mg/mL suspension compared to the crushed Daonil tablets.
Danish: Den relative biotilgængelighed var 121,6 % for suspensionen på 0,6 mg/ml, og 114,1 % for suspensionen på 6 mg/ml, i forhold til de knuste Daonil-tabletter.
English: If there is a clear reduction in insulin requirement at this dose of 2 mg/kg/day (reduction in insulin to at least 60% of pre-AMGLIDIA dose), then it is worth continuing a higher dose of AMGLIDIA over a prolonged period of time in selected cases.
Danish: Hvis der ved denne dosis på 2 mg/kg/dag er en klar reduktion af insulinbehovet (reduktion af insulin til mindst 60 % af dosis før AMGLIDIA), er det i udvalgte tilfælde værd at fortsætte med en højere dosis af AMGLIDIA gennem en længere periode.
English: In case of milk feeding, recommendation is given to administer the suspension 15 minutes before child's milk feeding.
Danish: Når barnet får mælk, anbefales det at indgive suspensionen 15 minutter før, barnet får mælk.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: As soon as insulin is discontinued, the dose of AMGLIDIA is adjusted according to capillary blood glucose.
Danish: Så snart insulin seponeres, skal dosis af AMGLIDIA justeres i overensstemmelse med kapillærblodglukose.
English: With respect to the 2nd and 3rd trimester published data did not find fetotoxic effects.
Danish: Hvad angår 2. og 3. trimester er der ikke fundet forstertoksiske virkninger i publicerede data.
English: Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins, include oral anticoagulants, phenytoin, salicylates and other non-steroidal anti-inflammatory agents.
Danish: Lægemidler med høj proteinbinding, som også kan potentiere den hypoglykæmiske virkning af glibenclamid på grund af fortrængning af glibenclamid fra plasmaproteiner, omfatter orale antikoagulantia, phenytoin, salicylater og andre non-steroide antiinflammatoriske lægemidler.
English: Administration through a feeding tube should be avoided.
Danish: Administration gennem sonde til enteral ernæring bør undgås.
English: Under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
Danish: Under påvirkning af sympatolytiske lægemidler som betablokkere, clonidin, guanethidin og reserpin kan tegnene på adrenerg modregulering af hypoglykæmi være reducerede eller mangle.
English: The values for maximum plasma concentrations (Cmax) were similar for the two suspensions (201.71 ± 71.43 ng/mL for the 6 mg/mL suspension and 206.93 ± 67.33 ng/mL for the 0.6 mg/mL suspension).
Danish: De maksimale plasmakoncentrationer (Cmax) var ens for de to suspensioner (201,71 ± 71,43 ng/ml for suspensionen på 6 mg/ml og 206,93 ± 67,33 ng/ml for suspensionen på 0,6 mg/ml).
English: Since AMGLIDIA is administered with an oral syringe graduated in mL, the calculated daily dose should be expressed in mL by the physician explicitly stating the strength to be used.
Danish: Da AMGLIDIA indgives med en oral sprøjte inddelt i ml, bør lægen udtrykke den beregnede dagsdosis i ml med udtrykkelig angivelse af, hvilken styrke der skal anvendes.
English: Adrenaline (epinephrine) and other sympathomimetic agents (used to treat serious allergic reaction, cardiovascular arrest, asthma)
Danish: Adrenalin og andre sympatomimetika (anvendes til behandling af alvorlige allergiske reaktioner, hjertestop, astma)
English: This medicine contains 2.80 mg of sodium per mL.
Danish: Dette lægemiddel indeholder 2,80 mg natrium pr. ml.
English: The MAH shall ensure that, in each Member State where Amglidia is marketed, all healthcare professionals who are expected to prescribe Amglidia, have access to the following educational guide:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, der forventes at ordinere Amglidia i hver medlemsstat, hvor Amglidia markedsføres, har, adgang til følgende uddannelsesmateriale:
English: If capillary blood glucose is < 7 mmol/L reduce insulin.
Danish: Hvis kapillærblodglukose er <7 mmol/l, reduceres insulin.
English: If on insulin pump, reduce basal rate of insulin pump by 50% and reduce further in accordance with capillary blood-glucose measurements.
Danish: Hvis der anvendes insulinpumpe, reduceres insulinpumpens basalhastighed med 50 % og reduceres yderligere i overensstemmelse med målingerne af kapillærblodglukose.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Each syringe is included in a specific presentation.
Danish: Hver sprøjte er indeholdt i en specifik pakning.
English: In patients on sulphonylurea alone, blood glucose control has been improved after transfer to sulfonylureas with median [IQR] HbA1c of 5.9% [5.4-6.5%] at 1 year vs 8.0 % [7.2-9.2 %] before transfer (p< 0.0001), and remained very well controlled after 10 years with a median [IQR] HbA1c of 6.4% [5.9-7.2 %].
Danish: Hos patienter på sulfonylurinstof alene var blodglukosekontrol forbedret efter overførsel til sulfonylurinstoffer med median [IQR] HbA1c på 5,9 % [5,4-6,5 %] efter 1 år 8,0 % [7,2; 9,2 %] før overførsel (p< 0,0001) og var fortsat velkontrolleret efter 10 år med en median [IQR] HbA1c på 6,4 % [5,9-7,2 %].
English: If the child does not suck, slowly press the plunger of the syringe so that the suspension trickles into the mouth.
Danish: Hvis barnet ikke sutter, skal du langsomt trykke på sprøjtens stempel, så suspensionen siver ind i munden.
English: The doctor may start insulin therapy again, when ketonemia or ketonuria were found to be responsible for the major vomiting.
Danish: Lægen kan starte insulinbehandlingen igen, hvis det var ketonæmi eller ketonuri, der forårsagede den store opkastning.
English: Tell the doctor if your child is pale, sweating, has irregular heart rhythm or seems disoriented, confused or unresponsive.
Danish: Fortæl det til lægen, hvis dit barn er blegt, sveder, har uregelmæssig puls eller virker desorienteret, forvirret eller ikke reagerer.
English: Available data are described in section 5.2.
Danish: Tilgængelige data er beskrevet i pkt.
English: Abnormal blood test results (very common: may affect more than 1 in 10 people) Laboratory blood tests may show changes in blood cells (decrease in white blood cells: leucopenia) and effects on liver function (brief increase in enzymes called transaminases).
Danish: Abnorme blodprøveresultater (meget almindelig: forekommer hos mere end 1 ud af 10 personer) Blodprøver kan vise ændringer i blodlegemerne (fald i hvide blodlegemer (leukopeni)) og påvirkning af leverfunktionen (kortvarig stigning i enzymer kaldet transaminaser).
English: Prior to launch of Amglidia in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of an educational material for Amglidia, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden Amglidia lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den nationale kompetente myndighed om indholdet og udformningen af uddannelsesmaterialet om Amglidia, herunder kommunikationsmedier, distributionsmetoder og lignende.
English: Overdose of sulphonamides can result in hypoglycaemia.
Danish: Overdosering af sulfonamider kan medføre hypoglykæmi.
English: Treatment using sulphonylureas in neonatal diabetes linked to potassium channel disorders is supported by published studies showing measurable improvements in glycaemic control and suggesting neuro-psychomotor and neuro-psychological deficiencies, which are greater in younger patients.
Danish: Behandling med sulfonylurinstoffer ved neonatal diabetes knyttet til kaliumkanalforstyrrelser bekræftes af offentliggjorte undersøgelser, der viser målelig bedring af glykæmisk kontrol og tyder på neuro-psykomotoriske og neuropsykologiske mangler, som er større hos yngre patienter.
English: In case of a partial response on lower doses, as shown by reduced insulin requirements, a further dose increase up to 2.8 mg/kg/day may be tried in selected cases.
Danish: Ved partiel respons på lavere doser, som fremgår af reduceret insulinbehov, kan der i udvalgte tilfælde forsøges en yderligere dosisforøgelse på op til 2,8 mg/kg/dag.
English: There is a risk of hypoglycaemia.
Danish: Der er risiko for hypoglykæmi.
English: Finally, draw back the plunger until graduation corresponding to the prescribed dose in ml (figure 4C).
Danish: Træk til sidst stemplet tilbage til den inddeling, der svarer til den ordinerede dosis i ml (figur 4C).
English: White, odourless suspension.
Danish: Hvid suspension uden lugt.
English: 1 oral syringe (1 mL) 1 oral syringe (5 mL) 1 syringe adaptor.
Danish: 1 oral sprøjte (1 ml) 1 oral sprøjte (5 ml) 1 sprøjteadapter.
English: Make sure you have the box containing the syringe size prescribed by your doctor.
Danish: Sørg for, at du har den karton, der indeholder en sprøjte af den størrelse, lægen har ordineret.
English: Tell your doctor or pharmacist if you notice any of the following side effects: - Skin rash: itching, nettle rash (urticarial), allergic skin reaction, blistering of the skin, skin inflammation.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du oplever en eller flere af nedenstående bivirkninger: - Hududslæt: kløe, nældefeber (urticaria), allergisk hudreaktion, blærer i huden, hudbetændelse.
English: Hypoglycaemia may occur when taking other medicinal products.
Danish: Der kan forekomme hypoglykæmi ved anvendelse af andre lægemidler.
English: Oral glucose tolerance tests and intravenous glucose tolerance tests revealed good insulin response to glucose and maintained incretin effect after ten years.
Danish: Orale glukosetoleranstests og intravenøse glukosetoleranstests viste god insulinrespons på glukose og bevaret inkretinvirkning efter ti år.
English: The dose is measured by drawing the plunger of the syringe back until it reaches the marking for the dose the doctor has prescribed for your child.
Danish: Dosis afmåles ved at trække sprøjtens stempel tilbage, indtil det når mærket svarende til den dosis, lægen har ordineret til dit barn.
English: Ten patients (7 boys/3 girls) with KCNJ11 mutation, with median age 2.7 years (0.3 to 16.2) andmedian duration of glibenclamide therapy 2.3 years (6 days to 11.3 years) were treated.
Danish: Der blev behandlet 10 patienter (7 drenge/3 piger) med KCNJ11-mutationen, med medianalder 2,7 år (0,3 til 16,2) og median varighed af behandling med glibenclamid 2,3 år (6 dage til 11,3 år).
English: In those patients, treatment should be started at the lowest dose and dosage levels strictly followed, to avoid hypoglycaemic reactions (see section 4.4).
Danish: Hos sådanne patienter skal behandlingen påbegyndes ved laveste dosis, og dosisniveauet skal overholdes nøje for at undgå hypoglykæmiske reaktioner (se pkt.
English: Higher doses have occasionally been reported in the literature with doses as high as 2.8 mg/kg/day without undesirable effects and with full transfer off insulin.
Danish: Der er lejlighedsvis rapporteret højere doser i litteraturen med på op til 2,8 mg/kg/dag uden bivirkninger og med fuld overførsel fra insulin.
English: Teeth problems (common: may affect up to 1 in 10 people): - Tooth discoloration.
Danish: Tandproblemer (almindelig: forekommer hos indtil 1 ud af 10 personer): - Misfarvning af tænder
English: • Amglidia is a suspension to be administered with a provided oral syringe graduated in mL.
Danish: • Amglidia er en suspension, der skal indgives med den medfølgende orale sprøjte, som er inddelt i ml.
English: From data published in the literature, treatment with sulfonylurea is reported to be successful in approximately 90% of the patients with neonatal diabetes associated with K-ATP channel mutations.
Danish: Ifølge publicerede data i litteraturen er behandling med sulfonylurinstoffer rapporteret som vellykket hos ca. 90 % af patienterne med neonatal diabetes i forbindelse med mutationer af K-ATP-kanalen.
English: Insulin reduction should be done using the pre-meal glucose.
Danish: Insulin bør reduceres ved hjælp af glukose inden måltidet.
English: Cyclophosphamides
Danish: Cyclophosphamider
English: Sulphonylureas like glibenclamide have been shown to be effective in certain genetic mutations responsible for the genesis of neonatal diabetes.
Danish: Sulfonylurinstoffer som glibenclamid er påvist at være effektive ved visse genetiske mutationer, der er årsag til neonatal diabetes.
English: Diabetes symptoms may reappear and may lead to a serious disturbance of the body's metabolism with high blood levels of ketones (ketoacidosis), dehydration and disturbance of the balance of acids in the body.
Danish: Sukkersygesymptomerne kan vende tilbage og medføre alvorlig forstyrrelse af stofskiftet med højt indhold af ketoner i blodet (ketoacidose), dehydrering og forstyrrelse af syrebalancen.
English: Glibenclamide, a second-generation, short half-life sulphonylurea, is a hypoglycaemic agent that reduces blood-glucose by stimulating insulin release by the pancreas; this effect depends on the presence of active beta-cells or beta-cells made active by glibenclamide in the pancreatic islets in certain cases of neonatal diabetes.
Danish: Glibenclamid, der er et andengenerations sulfonylurinstof med kort halveringstid, er et hypoglykæmisk middel, som nedsætter blodglukose ved at stimulere frigivelsen af insulin fra pancreas; denne virkning afhænger af tilstedeværelsen af aktive ß-celler eller ß-celler, der er gjort aktive af glibenclamid, i pancreas-øerne ved visse tilfælde af neonatal diabetes.
English: Skin rash, pruritus, urticaria, allergic skin reaction.
Danish: Hududslæt, kløe, urticaria, allergisk hudreaktion.
English: - The active substance is glibenclamide.
Danish: - Aktivt stof: glibenclamid.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne), der er ansvarlig(e) for batchfrigivelse
English: Transitory diarrhea Abdominal pain Vomiting Dyspepsia
Danish: Forbigående diarré Abdominalsmerter Opkastning Dyspepsi
English: Signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent
Danish: Tegn på adrenerg modregulering af hypoglykæmi kan være reducerede eller mangle
English: There are 2 presentations for a same strength: one with a syringe of 1mL and one with a syringe of 5 mL.
Danish: der er 2 pakninger med samme styrke: en med en sprøjte på 1 ml og en med en sprøjte på 5 ml.
English: Isoniazid used to treat tuberculosis
Danish: Isoniazid, der anvendes til behandling af tuberkulose