FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Kisqali approved?
Danish: Hvorfor blev Kisqali godkendt?
English: Women taking Kisqali with letrozole lived on average 25.3 months without the disease getting worse compared with 16.0 months in those taking placebo with letrozole.
Danish: Kvinder, der tog Kisqali sammen med letrozol, levede i gennemsnit i 25,3 måneder uden forværring af sygdommen, mens kvinder, der fik placebo sammen med letrozol, levede i gennemsnit i 16,0 måneder uden forværring af sygdommen.
English: What is Kisqali and what is it used for?
Danish: Hvad er Kisqali, og hvad anvendes det til?
English: What are the risks associated with Kisqali?
Danish: Hvilke risici er der forbundet med Kisqali?
English: Kisqali is a cancer medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women.
Danish: Kisqali er et kræftlægemiddel til behandling af fremskreden eller metastatisk brystkræft (kræft, der har spredt sig til andre dele af kroppen) hos kvinder, der har passeret menopausen.
English: Kisqali is used with an aromatase inhibitor (a cancer medicine that reduces oestrogen).
Danish: Kisqali anvendes sammen med en aromatasehæmmer (et kræftlægemiddel, som reducerer østrogen).
English: The most common side effects with Kisqali (which may affect more than 1 in 5 people) are low levels of white blood cells, headache, back pain, nausea (feeling sick), vomiting, diarrhoea, constipation, tiredness, hair loss and rash.
Danish: De hyppigste bivirkninger ved Kisqali (som kan forekomme hos mere end 1 ud af 5 personer) er lave niveauer af hvide blodlegemer, hovedpine, rygsmerter, kvalme, opkastning, diarré, forstoppelse, træthed, hårtab og udslæt.
English: The most common severe side effects with Kisqali (which may affect more than 1 in 50 people) are low levels of white blood cells, nausea, vomiting, tiredness, back pain, abnormal blood tests for liver function and low levels of phosphate in the blood (hypophosphataemia).
Danish: De hyppigste alvorlige bivirkninger ved Kisqali (som kan forekomme hos mere end 1 ud af 50 personer) er lave niveauer af hvide blodlegemer, kvalme, opkastning, træthed, rygsmerter, unormale blodprøveresultater for leverfunktionen og lave niveauer af fosfat i blodet (hypofosfatæmi).
English: For more information about treatment with Kisqali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kisqali, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Kisqali used with an aromatase inhibitor increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2negative breast cancer that is advanced or metastatic.
Danish: Kisqali anvendt sammen med en aromatasehæmmer forlængede den tid, der gik, inden sygdommen blev værre hos kvinder, som havde passeret menopausen, og som havde HR-positiv og HER2-negativ fremskreden eller metastatisk brystkræft.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisqali have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kisqali.
English: For practical information about using Kisqali, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kisqali, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Kisqali used?
Danish: Hvordan anvendes Kisqali?
English: What benefits of Kisqali have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kisqali?
English: How does Kisqali work?
Danish: Hvordan virker Kisqali?
English: Up to 10
Danish: Op til 10
English: This can sometimes be severe and prolonged.
Danish: Den kan undertiden være svær og langvarig.
English: Date of first authorisation: 24th May 2018
Danish: Dato for første markedsføringstilladelse: 24. maj 2018
English: This may not be relevant for the target population.
Danish: Dette er ikke nødvendigvis relevant for målpopulationen.
English: The attending specialist should then be contacted.
Danish: Den ansvarlige specialist bør derefter kontaktes.
English: This medicinal product is contraindicated in the following cases:
Danish: Dette lægemiddel er kontraindiceret i følgende tilfælde:
English: In all cases, HbA1c must be monitored every three months.
Danish: HbA1c skal under alle omstændigheder overvåges hver tredje måned.
English: These resolved subsequently.
Danish: Dette svandt efterfølgende.
English: Always ask your child's doctor for advice in such circumstances.
Danish: Spørg altid barnets læge til råds under sådanne omstændigheder.
English: Animal studies do not indicate a teratogenic potential.
Danish: Dyrestudier tyder ikke på teratogent potentiale.
English: It is administered directly into the child's mouth.
Danish: Det administreres direkte i barnets mund.
English: Biological analyses:
Danish: Biologiske analyser:
English: Summary of the safety profile:
Danish: Sammenfatning af sikkerhedsprofilen:
English: (In rare cases, it has taken 4 months to wean off insulin completely).
Danish: (I sjældne tilfælde har det taget 4 måneder at afvænne patienten fuldstændigt fra insulin).
English: Glibenclamide should not be given during pregnancy.
Danish: Glibenclamid bør ikke gives under graviditet.
English: Tel: + 33 (0)1 58 28 16 80 Fax: + 33 (0)1 58 28 16 90
Danish: Tlf.: + 33 (0)1 58 28 16 80 Fax: + 33 (0)1 58 28 16 90
English: Clinical data are not available.
Danish: Der foreligger ingen kliniske data.
English: Hospitalisation may then prove necessary and sugar may have to be administered for several days.
Danish: Indlæggelse kan i så fald være nødvendig, og det kan være nødvendigt at administrere sukker i flere dage.
English: In very rare cases, an intolerance to alcohol may occur.
Danish: I meget sjældne tilfælde kan der forekomme alkoholintolerans.
English: This may be done as an outpatient.
Danish: Dette kan foretages som ambulant patient.
English: Do not give a double dose to make up for a forgotten dose.
Danish: Du må ikke give en dobbeltdosis som erstatning for den glemte dosis.
English: In isolated cases, photosensitivity may occur.
Danish: I enkelte tilfælde kan der forekomme fotosensitivitet.
English: You will be requested to bring back remaining AMGLIDIA oral suspension to your doctor at each consultation.
Danish: Du vil blive bedt om at medbringe den tilbageværende rest af AMGLIDIA oral suspension til lægen ved hver konsultation.
English: The following adverse reactions have been observed in a clinical study (Neogli study).
Danish: Følgende bivirkninger er iagttaget i et klinisk studie (Neogli-studiet).
English: However, reduced alertness may also be of concern when participating in road traffic.
Danish: Svækkelse af opmærksomheden kan dog også være bekymrende i trafikken.
English: It is recommended that such patients change treatment to insulin.
Danish: For sådanne patienter anbefales det, at de skifter behandling til insulin.
English: The bottle does not need to be shaken before administration.
Danish: Det er ikke nødvendigt at ryste flasken før administration.
English: Special care should be taken when calculating the dose.
Danish: Der bør udvises ekstra omhu ved beregning af dosis.
English: This medicine is not intended to be used in pregnant women and patients planning a pregnancy should inform their doctor.
Danish: Dette lægemiddel er ikke beregnet til anvendelse hos gravide, og patienter, der planlægger at blive gravide, bør underrette lægen.
English: It should be ensured that the proper dose and strength are communicated and dispensed.
Danish: Det bør sikres, at der formidles og udleveres den korrekte dosis og styrke.
English: Incorrect control of plasma sugar (see section 2 “Do not give AMGLIDIA”)
Danish: Ukorrekt kontrol af sukkerindholdet i plasma (se afsnit 2 "Giv ikke AMGLIDIA")
English: There is a risk of high blood sugar.
Danish: Der er risiko for højt blodsukker.
English: Before each administration, it should be verified that the correct strength and syringe are used.
Danish: Før hver administration bør det verificeres, at der anvendes korrekt styrke og sprøjte.
English: In addition undesirable effects gathered from the use in adults is of importance given the small database in children.
Danish: Bivirkninger baseret på brug hos voksne er desuden vigtige i betragtning af den lille mængde data om børn.
English: The medicine should be given at the same times each day.
Danish: Lægemidlet bør gives på samme klokkeslæt hver dag.
English: Give basal and bolus insulin as usual on Day 1.
Danish: Der gives basal- og bolusinsulin som sædvanligt på dag 1.
English: Pre-breakfast glucose may be very slow to fall.
Danish: Glukose før morgenmaden kan være meget længe om at falde.
English: Bullous eruptions, exfoliative dermatitis, erythema multiforme have occasionally been reported in adults.
Danish: Bulløse eruptioner, exfoliativ dermatitis og erythema multiforme er undertiden indberettet for voksne.
English: Adolescents are not in need of this oral suspension formulation.
Danish: Unge behøver ikke en formulering som denne orale suspension
English: Kidney failure does not affect its elimination as long as creatinine clearance remains above 30 ml/min.
Danish: Nyresvigt påvirker ikke dets elimination, så længe kreatininclearance er over 30 ml/min.
English: Blood affections generally reversible when treatment stops.
Danish: Påvirkning af blodet er sædvanligvis reversibel, når behandlingen ophører.
English: Concomitant use of alcohol and glibenclamide should be avoided.
Danish: Samtidig brug af alkohol og glibenclamid bør undgås.
English: - Transient visual disturbances.
Danish: - Forbigående synsforstyrrelser.
English: Monitoring and dosage adjustment of ciclosporin are therefore recommended when both medicinal products are co-administered.
Danish: Der anbefales derfor overvågning og dosisjustering af ciclosporin, når de to lægemidler administreres samtidigt.
English: The plasma glibenclamide levels in the simulated paediatric population were approximately 30%-60% lower than the adult levels.
Danish: Plasmaniveauerne af glibenclamid hos den simulerede pædiatriske population var ca. 30 % -60 % lavere end niveauerne hos voksne.
English: The food effect on the speed or the level of absorption of glibenclamide oral suspension has not been investigated.
Danish: Fødevarers effekt på absorptionshastigheden eller -niveauet af glibenclamid oral suspension er ikke undersøgt.
English: In some children glycemic control can be better achieved when AMGLIDIA is administered 3 times or 4 times daily.
Danish: Hos nogle børn kan glykæmisk kontrol bedre opnås, når AMGLIDIA administreres 3 eller 4 gange dagligt.
English: It is important you do not adjust yourself the doses of either AMGLIDIA or insulin, unless specifically directed to do so by your child's doctor.
Danish: Det er vigtigt, at du ikke selv justerer doserne af hverken AMGLIDIA eller insulin, medmindre du udtrykkeligt bliver bedt om det af barnets læge.
English: You should check your child's blood sugar (capillary blood sugar).
Danish: Du bør kontrollere dit barns blodsukker (kapillærblodsukker).
English: The glycosylated haemoglobin level should be measured every three months to assess the child's metabolic equilibrium.
Danish: Niveauet af glykosyleret hæmoglobin bør bestemmes hver tredje måned for at vurdere barnets metaboliske balance.
English: Keep the bottle tightly closed.
Danish: Flasken holdes tæt lukket.
English: Such low blood sugar should be managed by taking sugar by mouth followed by a snack or meal.
Danish: Et sådant lavt blodsukker skal behandles ved at tage sukker gennem munden efterfulgt af en snack eller et måltid.
English: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne France
Danish: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne Frankrig
English: Ask your doctor to determine at which frequency capillary blood sugar should be checked.
Danish: Bed lægen om at afgøre, hvor ofte der skal kontrolleres kapillærblodsukker.
English: Patients occasionally may have very high glucose values, i.e. > 20 mmol/L (> 360 mg/dL).
Danish: Nogle patienter kan lejlighedsvis have meget høje glukoseværdier, dvs. > 20 mmol/l (> 360 mg/dl).
English: There were no reported episodes of severe hypoglycaemia.
Danish: Der var ingen indberettede episoder af svær hypoglykæmi.
English: Ten patients were switched to glibenclamide oral suspension and treatment with oral suspension continued for 3 months.
Danish: Ti patienter blev overført til glibenclamid oral suspension, og behandlingen med oral suspension fortsatte i tre måneder.
English: Patients or their caretakers should be reminded to use the correct syringe as stated in their prescription.
Danish: patienterne eller deres omsorgspersoner bør påmindes om at anvende den korrekte sprøjte, som fremgår af deres recept.
English: In some cases these high glucose values seem to settle with the normal dose of AMGLIDIA.
Danish: I nogle tilfælde synes disse høje glukoseværdier at rette sig med den normale dosis AMGLIDIA.
English: Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).
Danish: Benzoatsalt kan bevirke øget gulsot (gulfarvning af hud og øjne) hos nyfødte (op til 4 uger gamle).
English: The risk of low blood sugar is increased if the medicine is not taken with a meal, is taken with alcohol, or if combined with certain medicines.
Danish: Risikoen for lavt blodsukker øges, hvis lægemidlet ikke tages sammen med et måltid, hvis det tages sammen med alkohol eller i kombination med visse lægemidler.
English: It should therefore not be prescribed for these patients, and the use of an alternative treatment is strongly recommended, if available.
Danish: Det bør derfor ikke ordineres til sådanne patienter, og det tilrådes kraftigt at anvende et behandlingsalternativ, hvis et sådant foreligger.
English: Safety and efficacy of Amglidia in elderly patients has not been established since the medicinal product is indicated in the paediatric population.
Danish: Sikkerheden og virkningen af AMGLIDIA hos ældre er ikke fastlagt, da lægemidlet er indiceret til den pædiatriske population.
English: Microvascular complications were reported in 7/81(9%) patients; there were no macrovascular complications.
Danish: Der blev indberettet om mikrovaskulære komplikationer hos 7/81 (9 %) patienter; der var ingen makrovaskulære komplikationer.
English: Patients with G6PD enzyme deficiency
Danish: Patienter med G6PD-enzymmangel
English: Transient visual disturbances (blurred vision or accommodation disorder), especially early in treatment, with or without glycaemic variation.
Danish: Forbigående synsforstyrrelser (sløret syn eller akkomodationsforstyrrelser), navnlig tidligt i behandlingen, med eller uden glykæmisk variation.
English: 1 x 30 mL bottle.
Danish: 1 x 30 ml flaske.
English: Do not lay the child down directly after administration.
Danish: Læg ikke barnet ned umiddelbart efter indgivelsen.
English: In some patients, there may be an initial diarrhea when the dose of glibenclamide suspension is increased but it settles if the dose is maintained.
Danish: Hos nogle patienter kan der være initial diarré, når dosis af glibenclamid-suspensionen øges, men dette svinder, hvis dosis fastholdes.
English: This medicine may cause allergic reactions, which may be serious in isolated cases, including difficulties to breath, low blood pressure and shock.
Danish: Dette lægemiddel kan forårsage allergiske reaktioner, som i enkelte tilfælde kan være alvorlige, herunder åndedrætsbesvær, lavt blodtryk og chok.
English: Repeat the same protocol every week until insulin independence is achieved.
Danish: Gentag samme protokol hver uge, indtil insulinuafhængighed er opnået.
English: Based on a limited amount of published data, the use of glibenclamide during the 1st trimester does not seem to cause an increase in congenital malformations.
Danish: Baseret på offentliggjorte data af begrænset omfang synes brugen af glibenclamid i 1. trimester ikke at medføre stigning i medfødte misdannelser.
English: Your doctor will prescribe the specific presentation and strength including the particular syringe you should use.
Danish: Lægen vil ordinere den specifikke pakning og styrke, herunder den bestemte sprøjte, du skal bruge.
English: Ciclosporin used to prevent rejection of the transplanted organ
Danish: Ciclosporin, der anvendes til at forhindre afstødning af det transplanterede organ
English: If your child presents any of theses symptoms, you should immediately go to the nearest emergency department.
Danish: Hvis dit barn har nogen af disse symptomer, skal du straks tage til nærmeste akutmodtagelse.
English: Overall, the safety profile of Glibenclamide is in line with the safety profile of others sulfonylureas.
Danish: Overordnet er sikkerhedsprofilen af glibenclamid på linje med sikkerhedsprofilen af andre sulfonylurinstoffer.
English: Then push the plunger to remove as many air bubbles as possible from the syringe (figure 4B).
Danish: Skub derefter på stemplet, så der fjernes så mange luftbobler som muligt fra sprøjten (figur 4B).
English: Close monitoring of blood-glucose by the patient's family must be continued until the family and the physician, if he/she had to be contacted, are certain that the patient is out of danger.
Danish: Blodglukose bør fortsat overvåges tæt af patientens familie, indtil familien og lægen (hvis det har været nødvendigt at kontakte denne) er sikre på, at patienten er uden for fare.
English: It may be necessary to adjust the dosage of AMGLIDIA in patients suffering from intercurrent infections, trauma, shock or anaesthesia:
Danish: Det kan være nødvendigt at justere dosis af AMGLIDIA hos patienter med tilstødende infektioner, traume, shock eller anæstesi:
English: Once steady state is reached, capillary blood glucose does no longer need to be daily monitored except in clinical situations at risk of metabolic unbalance (see below).
Danish: Når steady state er nået, er det ikke længere nødvendigt at overvåge kapillærblodglukose dagligt, undtagen i kliniske situationer hvor der er risiko for metabolisk ubalance (se nedenfor).
English: These values were approx. 40% greater than those obtained for the crushed tablet (148.34 ± 46.74 ng/mL).
Danish: Disse værdier var ca. 40 % større end dem, der blev opnået med den knuste tablet (148,34 ± 46,74 ng/ml).
English: After such a severe episode of hypoglycaemia, the child and family should see the child's doctor to check the appropriateness of the dose of glibenclamide suspension.
Danish: Efter en så svær episode af hypoglykæmi bør barnet og familien ses af barnets læge med henblik på kontrol af, om dosen af glibenclamid suspension er passende.
English: Repeat the same protocol every day until insulin independence is achieved.
Danish: Gentag samme protokol hver dag, indtil insulinuafhængighed er opnået.
English: After oral administration, glibenclamide is absorbed rapidly and induces its effect within 2.5 hours with a duration of up to 15 hours, although the elimination half-life is 5 to 10 hours.
Danish: Efter oral administration absorberes glibenclamid hurtigt og inducerer inden for 2,5 time sin virkning, der har en varighed på op til 15 timer trods eliminationshalveringstiden på 5 til 10 timer.
English: This medicine is an oral suspension, to be taken by mouth, which is a more convenient treatment for newborns and young children compared to regular injections of insulin.
Danish: Dette lægemiddel er en oral suspension, der skal tages gennem munden, som er en mere bekvem behandling til nyfødte og små børn end regelmæssige injektioner af insulin.
English: The minimum active concentration for the effect is considered to be 30-50 ng/mL glibenclamide.
Danish: Den laveste aktive koncentration, der frembringer virkningen, anses for at være 30-50 ng/ml glibenclamid.
English: Breast-feeding seems to be compatible, but as a precautious measure monitoring of the fully breast-fed infant's blood sugar level is advisable.
Danish: Amning synes at være foreneligt, men som sikkerhedsforanstaltning tilrådes det at overvåge det fuldt brysternærede barns blodsukker.
English: If you forget to give AMGLIDIA, there is a risk of high blood sugar.
Danish: Hvis du glemmer at give AMGLIDIA, er der risiko for højt blodsukker.
English: After enrolment, patients continued taking their usual doses of glibenclamide tablets for 1 month.
Danish: Efter inkludering fortsatte patienterne med deres sædvanlige doser af glibenclamid tabletter i 1 måned.
English: Clinical studies appear to suggest that CYP2C9 contributes significantly to glibenclamide metabolism in vivo.
Danish: Kliniske studier synes at tyde på, at CYP2C9 bidrager væsentligt til metaboliseringen af glibenclamid in vivo.
English: If no improvement is seen (unchanged insulin dose, similar glycaemic control and no improvement in neurology), AMGLIDIA should be discontinued.
Danish: Hvis der ikke ses forbedring (uændret insulindosis, samme glykæmiske kontrol og ingen forbedret neurologi), bør AMGLIDIA seponeres.
English: Contains sodium and benzoate, see leaflet for further information.
Danish: Indeholder natrium og benzoat, læs indlægssedlen for yderligere oplysninger.
English: Glibenclamide is completely metabolised by the liver into 3 inactive metabolites excreted via bile (60%) and urine (40%); elimination is complete in 45 to 72 hours.
Danish: Glibenclamid metaboliseres fuldstændigt i leveren til 3 inaktive metabolitter, der udskilles via galde (60 %) og urin (40 %); eliminationen er fuldstændig i løbet af 45 til 72 timer.
English: You must check your child's blood sugar (capillary blood sugar) and give AMGLIDIA as soon as you realise you have forgotten to use it.
Danish: Du skal kontrollere dit barns blodsukker (kapillærblodsukker) og give AMGLIDIA, så snart du bliver klar over, at du har glemt at bruge det.
English: With smaller bodyweight the concentration increased but exceeded the adult plasma levels in minimal extents only for poor metabolizers.
Danish: Ved mindre kropsvægt steg koncentrationen, men overskred kun for poor metabolizers minimalt plasmaniveauerne hos voksne.
English: While the child is awake, position the child in half-sitting position in the hollow of your arm, with the child's head resting on your arm.
Danish: Mens barnet er vågent, anbringes barnet i halvt siddende stilling omsluttet af din arm, så barnets hoved hviler på din arm.
English: It is recommended to wait for the child has swallowed the medicine before reverting back to lying position.
Danish: Det anbefales at vente på, at barnet har sunket lægemidlet, før barnet lægges tilbage i liggende stilling.
English: In case of major vomiting, ketonemia and ketonuria should be closely monitored by the treating doctor.
Danish: Ved større opkastninger bør ketonæmi og ketonuri overvåges nøje af den behandlende læge.
English: Potential risk
Danish: Potentiel risiko
English: Effect of interaction
Danish: Interaktionens virkning
English: Make sure that you use correct strength of the medicine and the appropriate oral syringe prescribed by your doctor to avoid accidental administration of too high or too low amounts.
Danish: Sørg for at bruge den korrekte styrke af lægemidlet og den egnede orale sprøjte, som er ordineret af lægen, så du undgår utilsigtet at indgive for store eller for små mængder.
English: Interactions of AMGLIDIA with other medicines are presented in the table below:
Danish: Vekselvirkninger (interaktioner) mellem AMGLIDIA og andre lægemidler er angivet i tabellen nedenfor: