FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Mayzent will ensure that doctors expected to prescribe the medicine receive educational materials, including a checklist covering the necessary screening, pre-treatment and longterm monitoring of patients.
Danish: Den virksomhed, der markedsfører Mayzent, skal sørge for, at de læger, der forventes at ordinere lægemidlet, modtager oplysningsmateriale, herunder en tjekliste, der omfatter den nødvendige screening, forbehandling og langtidsovervågning af patienterne.
English: By attaching to these receptors, siponimod stops lymphocytes from travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in MS.
Danish: Ved at binde til disse receptorer forhindrer siponimod lymfocytterne i at bevæge sig fra lymfeknuderne mod hjernen og rygmarven og begrænser dermed den skade, som de forårsager ved multipel sklerose.
English: The active substance in Mayzent, siponimod, blocks the action of some receptors (targets) on cells called sphingosine-1-phosphate receptors, which are involved in the movement of lymphocytes (immune cells) around the body.
Danish: Det aktive stof i Mayzent, siponimod, blokerer aktiviteten af visse cellereceptorer (mål), der kaldes sphingosin-1-fosfatreceptorer, som er med til at regulere lymfocytters (immune cellers) bevægelse i kroppen.
English: For more information about using Mayzent, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Mayzent, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: It is used in patients with active disease, which means that patients still have relapses or signs of inflammation can be seen in scans.
Danish: Det anvendes hos patienter med aktiv sygdom, dvs. patienter, der stadig får attakter, eller hos hvem scanninger viser tegn på inflammation.
English: The side effects with Mayzent are similar to those with another medicine (fingolimod) for MS working in a similar way, and are considered acceptable.
Danish: Bivirkningerne ved Mayzent svarer til bivirkningerne ved et andet lægemiddel (fingolimod) mod multipel sklerose, der virker på lignende måde, og anses som acceptable.
English: In MS, the immune system (the body's defences) attacks and damages the protective sheath around the nerves in the brain and spinal cord.
Danish: Ved multipel sklerose angriber og beskadiger immunsystemet (kroppens naturlige forsvar) den beskyttende skede omkring nerverne i hjernen og rygmarven.
English: During the study, 25% of patients with active secondary progressive MS taking Mayzent had disease progression compared with 35% of patients taking placebo (a dummy treatment).
Danish: I studiet sås sygdomsprogression hos 25 % af de patienter med aktiv sekundær progressiv multipel sklerose, der tog Mayzent, sammenholdt med 35 % af de patienter, der tog placebo (et uvirksomt stof).
English: For the full list of side effects and restrictions of Mayzent, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Mayzent fremgår af indlægssedlen.
English: Mayzent can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the management of MS.
Danish: Mayzent fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af multipel sklerose.
English: Mayzent must not be used in patients who are hypersensitive (allergic) to siponimod, or to peanut, soya or any of the other ingredients of the medicine.
Danish: Mayzent må ikke anvendes hos patienter, der er allergiske over for det aktive stof (siponimod), jordnødder, soja eller andre af indholdsstofferne.
English: Mayzent is a medicine used to treat adults with an advanced form of MS known as secondary progressive MS (MS).
Danish: Mayzent er et lægemiddel til behandling af voksne med en fremskreden form for multipel sklerose, der kaldes sekundær progressiv multipel sklerose.
English: How is Mayzent used?
Danish: Hvordan anvendes Mayzent?
English: How does Mayzent work?
Danish: Hvordan virker Mayzent?
English: What benefits of Mayzent have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mayzent?
English: Treatment is started with a dose of 0.25 mg daily for two days.
Danish: Behandlingen påbegyndes med en dosis på 0,25 mg dagligt i to dage, som derefter øges gradvist, indtil vedligeholdelsesdosen nås på den 6. dag.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mayzent have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mayzent.
English: Mayzent was effective at delaying the progression of secondary progressive MS in patients with active disease; however, the beneficial effects of the medicine were not demonstrated in patients without an active disease.
Danish: Mayzent er effektivt til at forsinke progressionen af sekundær progressiv multipel sklerose hos patienter med aktiv sygdom.
English: Maximum plasma concentration is reached within 30 minutes in children.
Danish: Den maksimale plasmakoncentration nås i løbet af 30 minutter hos børn.
English: This medicine may cause people to forget what happened after they have been given it.
Danish: Dette lægemiddel kan få personer til at glemme, hvad der skete, efter de fik det.
English: • You're unable to empty the syringe or you spill some of the contents
Danish: • Du ikke er i stand til at tømme sprøjten, eller du spilder noget af indholdet
English: Do not use this medicine if the packaging has been opened or damaged.
Danish: Brug ikke lægemidlet, hvis emballagen er blevet åbnet eller er beskadiget.
English: Less than 1% of the dose is recovered in urine as unchanged medicinal product..
Danish: Under 1 % af dosis genfindes i urinen som uændret lægemiddel.
English: This is due to an increase of approximately 50% in the volume of distribution corrected for total body weight.
Danish: Dette skyldes en forøgelse på ca. 50 % af fordelingsvoluminet, korrigeret for total kropsvægt.
English: In very rare cases breathing might stop.
Danish: meget sjældne tilfælde kan vejrtrækningen stoppe.
English: Standard doses are indicated below:
Danish: Standarddoser er indikeret nedenfor:
English: • Temporary memory loss.
Danish: • Midlertidigt hukommelsestab.
English: • Difficulty co-ordinating muscles
Danish: • Problemer med at koordinere muskler
English: • Do not give the patient another dose of BUCCOLAM.
Danish: • Giv ikke patienten endnu en dosis BUCCOLAM.
English: Read all of this leaflet carefully, before you start giving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at give dette lægemiddel, da den indeholder vigtige oplysninger.
English: The initial and terminal elimination half-lives are 27 and 204 minutes, respectively.
Danish: De initiale og terminale halveringstider for elimination er hhv. 27 og 204 minutter.
English: Do not give more than one dose.
Danish: Giv ikke mere end én dosis.
English: The information on how to give this medicine is also shown on the tube label.
Danish: Vejledning i at give dette lægemiddel er også vist på tubens etiket.
English: If in any doubt, call for immediate medical help if:
Danish: Hvis du er i tvivl, skal du søge øjeblikkelig lægehjælp, hvis:
English: The major fraction of plasma protein binding is due to albumin.
Danish: Den største fraktion af plasmaproteinbinding skyldes albumin.
English: Depending on age, your child will have received one of the following doses, in specifically colour labelled packaging:
Danish: Afhængigt af alderen har dit barn fået en af følgende doser i pakninger med specifikke farver på etiketten:
English: Do not give more than the amount of medicine prescribed by a doctor for the patient.
Danish: Giv ikke mere end den mængde lægemiddel, som lægen har ordineret til patienten.
English: • If the seizure does not stop within 10 minutes, call an ambulance.
Danish: • Hvis krampeanfaldet ikke stopper inden for 10 minutter, skal du ringe efter en ambulance.
English: 1000 Brussels Belgium
Danish: 1000 Bruxelles Belgien
English: Please discuss with your doctor if you need further advice.
Danish: Rådfør dig med lægen, hvis du har behov for yderligere rådgivning.
English: Only move them if they are in danger from, for example, deep water, fire or sharp objects.
Danish: Barnet må kun flyttes, hvis der er fare, f.eks. dybt vand, ild eller skarpe genstande.
English: If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption.
Danish: Hvis det ikke er nogen fordel af at tømme maven, skal der gives aktivt kul for at reducere absorptionen.
English: Keep the syringe to show to the ambulance staff or doctor.
Danish: Behold sprøjten, så du kan vise den til ambulancepersonalet eller lægen.
English: Children younger than 3 months: BUCCOLAM should not be given to children younger than 3 months since there is not enough information in this age group.
Danish: Børn under 3 måneder: BUCCOLAM må ikke gives til børn under 3 måneder, da der ikke er tilstrækkelig information for denne aldersgruppe.
English: A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2).
Danish: En anden eller gentagen dosis når anfald opstår igen efter et initial respons skal ikke gives uden medicinsk rådgivning på forhånd (se pkt.
English: Approximately 96-98% of midazolam is bound to plasma proteins.
Danish: Ca. 96-98 % af midazolam er bundet til plasmaproteiner.
English: Exposure following a second dose in the same seizure episode Simulated exposure data show that the overall AUC approximately doubles when a second dose is administered at 10, 30 and 60 minutes following the first dose.
Danish: Eksponering efter en anden dosis i løbet af den samme anfaldsperiode Simulerede eksponeringsdata viser, at det samlede AUC ca. fordobles, når en anden dosis indgives 10, 30 og 60 minutter efter den første dosis.
English: Paediatric patients aged 3 to 6 months
Danish: Pædiatriske patienter i alderen 3 til 6 måneder
English: The safety and efficacy of midazolam in children aged 0 to 3 months has not been established.
Danish: Midazolams sikkerhed og virkning hos børn i alderen 0 til 3 måneder er ikke klarlagt.
English: Do not give BUCCOLAM if the patient has:
Danish: Giv ikke BUCCOLAM, hvis patienten har:
English: Flumazenil may be useful as an antidote.
Danish: Flumazenil kan være nyttig som en antidot.
English: Small quantities of midazolam are found in human milk.
Danish: Små mængder midazolam findes i human mælk.
English: BUCCOLAM may make the patient sleepy, forgetful or affect their concentration and co-ordination.
Danish: BUCCOLAM kan gøre patienten søvnig, glemsom eller påvirke koncentrationen og koordinationen.
English: Check that the medicine is the correct dose for your child, according to their age.
Danish: Kontroller, at det er den korrekte dosis lægemiddel til dit barn i henhold til barnets alder.
English: Midazolam is almost entirely eliminated by biotransformation.
Danish: Midazolam er næsten udelukkende elimineret via biotransformation.
English: Ask a doctor, pharmacist or nurse to show you how to take or administer this medicine.
Danish: Bed en læge, apotekspersonalet eller en sygeplejerske om at vise dig, hvordan du skal tage eller indgive denne medicin.
English: In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Danish: Ved behandling af en overdosering med alle former for lægemidler, skal der tages hensyn til, at der kan være indtaget flere stoffer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with BUCCOLAM in the subset of the paediatric population < 3months old, on the grounds that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for these paediatric patients.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med BUCCOLAM i undergruppen af den pædiatriske population < 3 måneder, med den begrundelse, at det specifikke lægemiddel ikke repræsenterer en signifikant terapeutisk fordel i forhold til eksisterende behandlinger for disse pædiatriske patienter.
English: Do not give more than one dose Step 1
Danish: Giv ikke mere end én dosis Trin 1
English: No data on exposed pregnancies are available for the first two trimesters of pregnancy.
Danish: Der er ingen tilgængelige data fra eksponerede graviditeter for graviditetens første to trimestre.
English: Calcium-channel blockers
Danish: Calciumkanal-blokkere
English: Support your child's head with something soft, such as a cushion or your lap.
Danish: Støt barnets hoved med noget blødt, såsom en pude eller dit skød.
English: An increased risk for falls and fractures has been recorded in elderly benzodiazepine users.
Danish: En øget risiko for faldtendens og frakturer er blevet registreret hos ældre brugere af benzodiazepiner.
English: Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use.
Danish: Respirationsdepression forekommer med en hyppighed på op til 5 %, selvom dette er en kendt komplikation ved anfald såvel som relateret til anvendelsen af midazolam.
English: How long this lasts depends on how much BUCCOLAM was given..
Danish: Hvor længe, dette varer, afhænger af, hvor meget BUCCOLAM barnet har fået.
English: Your doctor will prescribe the appropriate dose of BUCCOLAM your child needs, generally according to your child's age.
Danish: Lægen vil ordinere den dosis BUCCOLAM, som dit barn har behov for, normalt i henhold til barnets alder.
English: Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Danish: Der skal tages særligt hensyn til respiratoriske og kardiovaskulær funktioner ved intensivbehandling.
English: Nausea and vomiting Very rare:
Danish: Kvalme og opkastning Meget sjælden:
English: 6.6 Special precautions for disposal and other handling Administration of BUCCOLAM
Danish: 6.6 Regler for bortskaffelse og anden håndtering Administration af BUCCOLAM
English: The terminal half-life decreased by about 50-60%.
Danish: Den terminale halveringstid var reduceret med ca. 50 - 60 %.
English: Altered elimination of midazolam
Danish: Ændret elimination af midazolam
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - 2Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: - på anmodning fra Det Europæiske Lægemiddelagentur - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: There are no or limited amount of data from the use of midazolam in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af midazolam til gravide kvinder.
English: This should be avoided in patients taking BUCCOLAM.
Danish: Dette skal undgås hos patienter, der tager BUCCOLAM.
English: Even though small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop breast-feeding.
Danish: Selvom små mængder BUCCOLAM kan udskilles i mælken, kan det være, at det ikke er nødvendigt at stoppe amningen.
English: This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.
Danish: Dette er meget vigtigt, da virkningen af de involverede lægemidler kan styrkes eller svækkes, når der bruges mere end en form for medicin på samme tid.
English: As a result it may not be necessary to stop breast feeding following a single dose of midazolam.
Danish: Som et resultat heraf kan det være, at det ikke er nødvendigt at stoppe amningen efter en enkelt dosis midazolam.
English: Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 5. september 2011 Dato for seneste fornyelse: 26. kan 2016
English: The different doses each have a different colour, which is shown on the carton, the tube and the syringe containing the medicine.
Danish: De forskellige doser har forskellige farver, hvilket er vist på kartonen, tuben og sprøjten med lægemidlet.
English: 3 to 6 months hospital setting
Danish: 3 til 6 måneder hospitalsregi
English: The risk for new-born infants should be taken into account in the event of administration of midazolam in the third trimester of pregnancy.
Danish: Risikoen for nyfødte spædbørn skal tages i betragtning i tilfælde af indgivelse af midazolam i løbet af graviditetens tredje trimester.
English: Pharmacodynamic Drug-Drug Interactions (DDI)
Danish: Farmakodynamiske lægemiddelinteraktioner (drug-drug interactions, DDI)
English: Midazolam is excreted in low quantities (0.6%) in human milk.
Danish: Midazolam udskilles i små mængder (0,6 %) i human mælk.
English: If the patient who will be given this medicine is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask a doctor for advice before taking this medicine.
Danish: Hvis patienten, der får denne medicin, er gravid eller ammer, har mistanke om, at hun er gravid, eller planlægger at blive gravid, skal lægen spørges til råds, før dette lægemiddel tages.
English: • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis)
Danish: • En sygdom i nerver og muskler, der forårsager muskelsvaghed (myasthenia gravis)
English: • Muscle spasms and muscle tremors (shaking of your muscles that you cannot control)
Danish: • Muskelspasmer og muskelrysten (rysten af dine muskler, som du ikke kan kontrollere)
English: In a population pharmacokinetic study, the metabolite levels are shown to be higher in younger than older paediatric patients and thus likely to be of more importance in children than in adults.
Danish: I et populationsfarmakologisk studie blev det vist, at niveauet af metabolit er større hos yngre end hos ældre pædiatriske patienter, og det er derfor sandsynligt, at det er af større vigtighed hos børn end hos voksne.
English: • The seizure does not stop within 10 minutes
Danish: • Krampeanfaldet ikke stopper i løbet af 10 minutter
English: Preparing to give this medicine
Danish: Forberedelse til at give lægemidlet
English: There is a slow and insignificant passage of midazolam into the cerebrospinal fluid.
Danish: Der er en langsom og ikke signifikant passage af midazolam ind i cerebrospinalvæsken.
English: It also exerts a sedative and sleepinducing effect of pronounced intensity, and an anxiolytic and a muscle-relaxant effect.
Danish: Det udøver også en sederende og søvninducerende virkning af udpræget intensitet og en anxiolytisk og muskelafslappende virkning.
English: 1000 Brussels
Danish: 1000 Bruxelles
English: If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.
Danish: Hvis anfaldet ikke er stoppet i løbet af 10 minutter efter indgivelse af midazolam, skal der søges akutmedicinsk hjælp, og den tomme sprøjte skal gives til sundhedspersonalet for at give information om den dosis, patienten har fået.
English: Babies born after this medicine is administered during childbirth can also have poor suckling, breathing difficulties and poor muscle tone at birth.
Danish: Børn, der fødes efter dette lægemiddel blev anvendt under fødslen, kan også have en dårlig sutterefleks, vejrtrækningsbesvær og dårlig muskeltonus ved fødslen.
English: • Sleepiness or losing consciousness
Danish: • Søvnighed eller bevidsthedstab
English: After oromucosal administration, only systemic clearance will be affected.
Danish: Efter indgivelse via mundhulen vil kun den systemiske clearance påvirkes.
English: The free base is a lipophilic substance with low solubility in water.
Danish: Den frie base er et lipofilt stof med en lav vandopløselighed.
English: The pharmacological action of midazolam is characterized by short duration because of rapid metabolic transformation.
Danish: Midazolams farmakologiske virkning er karakteriseret ved en kort varighed på grund af en hurtig metabolisk transformation.
English: Patients should be observed carefully after being given the medicine.
Danish: Børnene skal observeres nøje, efter de har fået lægemidlet.
English: Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution.
Danish: Laryngotrakeal indsættelse skal undgås for at undgå utilsigtet aspiration af opløsningen.
English: One episode of pruritus was possibly attributed to the use of buccal midazolam.
Danish: En episode med pruritus kunne muligvis skyldes brugen af bukkal midazolam.
English: Midazolam has an anticonvulsant effect.
Danish: Midazolam har en antikonvulsiv virkning.
English: Simulated pharmacokinetic parameters for the recommended posology in children aged 3 months to less than 18 years, based on a population pharmacokinetic study are provided in tabulated format below:
Danish: Simulerede farmakokinetiske parametre for den anbefalede dosering til børn i alderen 3 måneder til under 18 år, baseret på et populationsfarmakologisk studie, gives i tabelform nedenunder:
English: Antiepileptics
Danish: Antiepileptika
English: The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables midazolam to form the hydrochloride salt with acids.
Danish: Den basiske nitrogen i position 2 af imidazobenzodiazepin ringsystemet gør midazolam i stand til at danne hydrochloridsaltet med syrer.
English: Midazolam is highly lipophilic and distributes extensively.
Danish: Midazolam er meget lipofilt og fordeles ekstensivt.
English: Pharmacotherapeutic group: Psycholeptics, benzodiazepine derivatives ATC code: N05CD08.
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, benzodiazepin-derivater ATC-kode: N05CD08.
English: • antihistamines (to treat allergies).
Danish: • antihistaminer (til behandling af allergi).
English: Giving high doses of BUCCOLAM during the last 3 months of pregnancy can cause abnormal heart beat in the unborn child.
Danish: Hvis der gives høje doser af BUCCOLAM i løbet af de sidste 3 måneder af graviditeten, kan det forårsage unormal hjerterytme hos det ufødte barn.
English: There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
Danish: Der er ingen andre prækliniske data af relevans for den ordinerende læge ud over dem, som allerede er inkluderet i andre afsnit i produktresumeet.
English: Metabolism of midazolam and other benzodiazepines is accelerated by xanthines.
Danish: Metabolismen af midazolam og andre benzodiazepiner accelereres af xanthiner.
English: Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.
Danish: Da forholdet mellem metabolit og udgangsstof er større hos yngre børn, kan en forsinket respirationsundertrykkelse som et resultat af en høj aktiv metabolitkoncentration i aldersgruppen 3-6 måneder ikke udelukkes.
English: Signs may include chest pain which may spread to the child's neck and shoulders and down their left arm.
Danish: Tegn kan omfatte brystsmerter, som kan spredes til barnets hals og skuldre og ned i den venstre arm.
English: • A lung condition that causes difficulty breathing on a regular basis.
Danish: • En lungesygdom, der regelmæssigt forårsager vejrtrækningsbesvær.