FrancophonIA/ELRC3.0 huggingface dataset:
English: To prevent side effects, the dose of Nemdatine is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Nemdatine gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: The Committee recommended that Nemdatine be approved for use in the EU.
Danish: Udvalget anbefalede, at Nemdatine godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Nemdatine?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nemdatine?
English: In addition, overstimulation of the NMDA receptors may result in cell damage or death.
Danish: Desuden kan overstimulering af NMDA-receptorerne medføre cellebeskadigelse eller -død.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Danish: Neurotransmittere er kemiske stoffer i nervesystemet, der gør det muligt for nerveceller at kommunikere med hinanden.
English: Nemdatine is a ‘generic medicine'.
Danish: Nemdatine er et "generisk lægemiddel".
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Danish: Behandling bør kun indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom.
English: It contains the active substance memantine.
Danish: Det indeholder det aktive stof memantin.
English: What are the benefits and risks of Nemdatine?
Danish: Hvilke fordele og risici er der forbundet med Nemdatine?
English: Nemdatine is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Nemdatine er et lægemiddel til behandling af patienter med moderat til svær Alzheimers sygdom, dvs. en type demens (en hjernesygdom), der gradvis påvirker hukommelse, intellektuelle evner og adfærd.
English: What is Nemdatine and what is it used for?
Danish: Hvad er Nemdatine, og hvad anvendes det til?
English: Nemdatine is available as 5 mg, 10 mg, 15 mg and 20 mg tablets and can only be obtained with a prescription.
Danish: Nemdatine fås som tabletter (5 mg, 10 mg, 15 mg og 20 mg) og udleveres kun efter recept.
English: This means that Nemdatine is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Danish: Det betyder, at Nemdatine er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Ebixa.
English: The cause of Alzheimer's disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.
Danish: Årsagen til Alzheimers sygdom er ukendt, men den hukommelsessvækkelse, sygdommen medfører, menes at skyldes forstyrrelse af signaler i hjernen.
English: The active substance in Nemdatine, memantine, is an antidementia medicine.
Danish: Det aktive stof i Nemdatine, memantin, er et lægemiddel mod demens.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Nemdatine should be reassessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Nemdatine by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Nemdatine.
English: It is not intended to provide practical advice on how to use Nemdatine.
Danish: Det er ikke en praktisk vejledning i, hvordan Nemdatine bør anvendes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nemdatine has been shown to have comparable quality and to be bioequivalent to Ebixa.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Nemdatine er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
English: Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Danish: Memantin virker ved at blokere en bestemt type receptorer kaldet NMDA-receptorer, som signalstoffet glutamat normalt binder sig til.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Nemdatine, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nemdatine, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Why is Nemdatine approved?
Danish: Hvorfor er Nemdatine blevet godkendt?
English: For more information about treatment with Nemdatine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nemdatine, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Ebixa.
English: Because Nemdatine is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Nemdatine er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Nemdatine is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Danish: Da Nemdatine er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Ebixa.
English: For practical information about using Nemdatine, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Nemdatine, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Danish: Memantin forbedrer signaloverførslen i hjernen ved at blokere NMDA-receptorerne, så symptomerne på Alzheimers sygdom mindskes.
English: How has Nemdatine been studied?
Danish: Hvordan er Nemdatine blevet undersøgt?
English: How is Nemdatine used?
Danish: Hvordan anvendes Nemdatine?
English: The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Danish: Ved moderat eller svær nyresygdom kan det være nødvendigt med en lavere dosis.
English: For more information, see the package leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: How does Nemdatine work?
Danish: Hvordan virker Nemdatine?
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Danish: Den hukommelsessvækkelse, der ses ved Alzheimers sygdom, er blevet sat i forbindelse med ændringer i signaloverførslen via glutamat i hjernen.
English: The Prescriber Guide should highlight the following:
Danish: Ordinationsvejledningen bør sætte fokus på følgende:
English: • Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Danish: • Patientudvælgelseskriterier, herunder at pioglitazon ikke bør bruges som førstelinjebehandling og understregning af behovet for regelmæssig vurdering af fordele ved behandlingen.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Danish: Forud for udlevering af ordinationsvejledningen i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen og den nationale kompetente myndighed blive enige om indholdet og formatet af informationsmaterialet samt en kommunikationsplan.
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Danish: Indehaveren af markedsføringstilladelsen skal udarbejde informationsmateriale, som er målrettet alle læger, som forventes at ordinere/anvende pioglitazon.
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states.
Danish: Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, der skal implementeres af medlemslandene.
English: • This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Danish: • Informationsmaterialet har til formål at skærpe opmærksomheden omkring vigtige identificerede risici for blærecancer og hjerteinsufficiens, og de overordnede anbefalinger har til formål at optimere risk-benefit-balancen på patientniveau.
English: • The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Danish: • Informationsmaterialet til lægen bør omfatte: Produktresumé, indlægsseddel og en ordinationsvejledning.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer,
Danish: • Forsigtighed ved brug hos ældre i lyset af aldersbetingede risici (især blærecancer, knoglebrud og hjerteinsufficiens).
English: • The risk of heart failure and relevant risk minimisation advice.
Danish: • Risikoen for hjerteinsufficiens og relevant rådgivning om risikominimering.
English: • The risk of bladder cancer and relevant risk minimisation advice.
Danish: • Risikoen for blærecancer og relevant rådgivning om risikominimering.
English: Package size l t o r
Danish: Pakningsstørrelse l t o r
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Indgivelsesvej
English: EU Number
Danish: EU-nummer.
English: The recommended dose is:
Danish: Den anbefalede dosis er:
English: The dose given depends on your weight.
Danish: Den dosis, der gives, afhænger af din vægt.
English: Avoid vigorous mixing.
Danish: Undgå voldsom blanding.
English: • severe allergic reactions,
Danish: • alvorlige allergiske reaktioner,
English: Date of first authorisation: 23 March 2015 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 23 marts 2015 Dato for seneste fornyelse:
English: very rare (<1/10,000).
Danish: meget sjælden (<1/10.000).
English: The doctor will decide if you will need to be treated for longer periods.
Danish: Lægen bestemmer, om du behøver at blive behandlet i længere tid.
English: • You suffer from breathing difficulties such as asthma.
Danish: • du har åndedrætsbesvær, såsom astma.
English: Tell your doctor immediately if you notice any of the following:
Danish: Fortæl det straks til lægen, hvis du bemærker noget af følgende:
English: In this study, semen analysis was conducted after 8 weeks of continuous treatment.
Danish: I dette studie blev semen analyseret efter 8 ugers uafbrudt behandling.
English: Swirl gently until all material is dissolved.
Danish: Drej forsigtigt rundt, indtil alt materiale er opløst.
English: In clinical studies, healthy volunteers received up to two times the proposed daily dose.
Danish: I kliniske studier fik raske frivillige op til 2 gange den foreslåede daglige dosis.
English: The bioavailability of cangrelor is complete and immediate.
Danish: Cangrelors biotilgængelighed er fuldstændig og øjeblikkelig.
English: The doctor will decide how much Kengrexal you receive, and will prepare the medicine.
Danish: Lægen bestemmer, hvor meget Kengrexal du får, og forbereder medicinen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens eget ansvar.
English: Sorbitol is a source of fructose.
Danish: Sorbitol er en kilde til fructose.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: - If you have uncontrolled very high blood pressure.
Danish: - hvis du har meget højt, ubehandlet blodtryk.
English: Severe/life-threatening
Danish: Alvorlig/livstruende
English: Initial excretion was rapid, such that approximately 50% of the administered radioactivity was recovered in the first 24 hours, and 75% was recovered by 48 hours.
Danish: Startudskillelse var hurtig, så ca. 50 % af den administrerede radioaktivitet blev genvundet i løbet af de første 24 timer, og 75 % var genvundet efter 48 timer.
English: Adverse reactions are classified according to frequency and system organ class.
Danish: Bivirkninger er klassificeret efter hyppighed og systemorganklasse.
English: Bleeding is the most likely pharmacological effect of overdose.
Danish: Blødning er den mest sandsynlige farmakologiske virkning af overdosering.
English: ** Transfusion was uncommon 101/12,565 (0.8%).
Danish: ** Transfusion var ikke almindelig 101/12.565 (0,8 %).
English: Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Danish: Data fra den sammenlagte CHAMPION-population med over 25.000 PCI-patienter giver yderligere klinisk støtte for sikkerheden.
English: No dose adjustment is needed in elderly (≥75 years) patients.
Danish: Dosisjustering er ikke nødvendig hos ældre (≥ 75 år) patienter.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Danish: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000),
English: Mean clearance was approximately 43.2 L/kg.
Danish: Gennemsnitlig clearance var ca. 43,2 l/kg.
English: Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below: a.
Danish: Flere relaterede termer for bivirkninger er samlet i tabellen og omfatter medicinske termer som beskrevet herunder: a.
English: System organ class
Danish: Organsystemklasse
English: Do not use without dilution.
Danish: Må ikke bruges uden fortynding.
English: It is unknown whether Kengrexal is excreted in human milk.
Danish: Det er ukendt, om Kengrexal udskilles i human mælk.
English: Breast cancer resistance protein (BCRP)
Danish: Brystcancer-resistensprotein (BCRP)
English: Instructions for preparation
Danish: Instruktioner for forberedelse
English: The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer.
Danish: Bolus og infusion skal iværksættes før proceduren og fortsættes i mindst 2 timer eller under hele proceduren, hvad der end er længst.
English: Aseptic procedures should be used for the preparation of Kengrexal.
Danish: Der skal anvendes aseptiske procedurer til forberedelse af Kengrexal.
English: • Bleeding from anywhere in the body.
Danish: • Blødning hvor som helst i kroppen.
English: Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects.
Danish: Din læge beslutter, hvordan du skal behandles, og vil bl.a. stoppe lægemidlet og overvåge dig for tegn på bivirkninger.
English: Start the infusion immediately after administration of the bolus.
Danish: Start infusion straks efter administration af bolus.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Danish: Patienter med HFI kan ikke nedbryde fructose, hvilket kan medføre alvorlige bivirkninger.
English: The median duration of cangrelor infusion was 129 minutes.
Danish: Cangrelorinfusionens medianvarighed var 129 minutter.
English: Bleeding can be serious, and fatal outcomes have been reported.
Danish: Blødning kan være alvorlig, og der er rapporteret dødsfald.
English: • You have been told by your doctor that you have an intolerance to some sugars.
Danish: • lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: No dose adjustment is needed for these populations.
Danish: Dosisjustering er ikke nødvendig i disse populationer.
English: These effects were not apparent at lower doses and were reversible following cessation of dosing.
Danish: Disse virkninger var ikke synlige ved lavere doser og var reversible efter seponering af dosis.
English: GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of patients.
Danish: GPIIb/IIIa-hæmmere var kun tilladt som redningsbehandling og blev anvendt til 2,9 % af patienterne.
English: Possible implications for the in vivo situation have not been investigated, but caution is advised when cangrelor is to be combined with a BCRP substrate.
Danish: Mulige konsekvenser for situationen in vivo er ikke blevet undersøgt, men forsigtighed tilrådes, når cangrelor skal kombineres med et BCRP-substrat.
English: IDR a Primary endpoint from logistic regression adjusted for loading dose and patient status.
Danish: IDR aPrimært endepunkt fra logistisk regression justeret for belastningsdosis og patientstatus.
English: • You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
Danish: • du nogensinde har haft en allergisk reaktion på Kengrexal eller et af dets indholdsstoffer.
English: Cangrelor should be used with caution in these patients.
Danish: Cangrelor skal bruges med forsigtighed til disse patienter.
English: There are no or limited amount of data from the use of Kengrexal in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Kengrexal til gravide kvinder.
English: • swollen face.
Danish: • hævelser i ansigtet.
English: Carcinogenicity studies have not been performed.
Danish: Der er ikke udført studier af karcinogent potentiale.
English: Cytochrome P450 (CYP)
Danish: Cytokrom P450 (CYP)
English: See section 4.2 for information on paediatric use.
Danish: 4.2 for oplysninger om pædiatrisk anvendelse).
English: • Bleeding under the skin or around the eye,
Danish: • Blødning under huden eller omkring øjet,
English: This medicine will be given to you by a healthcare professional.
Danish: Du får denne medicin af sundhedspersonale.
English: If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Danish: Hvis du har arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, må du ikke få dette lægemiddel.
English: This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required.
Danish: Denne opløsning genererer en koncentration på 200 mikrogram/ml og bør være tilstrækkelig til mindst 2 timers dosering efter behov.
English: • variations in blood pressure,
Danish: • variationer i blodtryk,
English: p-values for secondary endpoints based on Chi-squared test.
Danish: p-værdier for sekundære endepunkter baseret på Chi-square-test.
English: Non-clinical data reveal no special safety risk for humans based on studies of safety pharmacology, mutagenicity and clastogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, mutagenicitet og klastogent potentiale.
English: Patients 100 kg and over will require a minimum of two bags.
Danish: Patienter, som vejer 100 kg og derover, skal have mindst 2 poser.
English: Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound.
Danish: Cangrelor har et fordelingsvolumen 3,9 l. Cangrelor er 97-98 % proteinbundet i plasma.
English: The medicinal product should be inspected visually for particulate matter after reconstitution.
Danish: Lægemidlet skal inspiceres visuelt for partikelmateriale efter rekonstitution.
English: IDR a p-values based on Chi-squared test.
Danish: IDR a p-værdier baseret på Chi-square-test.
English: If side effects occur, they may need medical attention.
Danish: Hvis der forekommer bivirkninger, kan de kræve lægehjælp.
English: No interaction on cangrelor was observed.
Danish: Der blev ikke observeret nogen interaktion for cangrelor.
English: • Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the site of an injection under the skin causing swelling),
Danish: • Mindre blå mærker kan forekomme overalt på kroppen (herunder også små røde mærker på huden eller ved injektionsstedet under huden, der medfører hævelse),
English: Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data from all CHAMPION studies.
Danish: Tabel 1 viser bivirkninger, der er påvist efter en sammenlægning af kombinerede data fra alle CHAMPION-studier.
English: Talk to your doctor before using Kengrexal if:
Danish: Fortæl det til lægen, før du får Kengrexal hvis:
English: The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients and healthy volunteers.
Danish: Cangrelors farmakokinetiske egenskaber er vurderet og påvist at være lineære hos patienter og raske frivillige.
English: Death/MI/IDR/ST
Danish: Dødsfald/MI/IDR/ST
English: You must tell your doctor before receiving this medicine if you have HFI.
Danish: Inden du får dette lægemiddel, skal du fortælle din læge, hvis du har HFI.
English: Risk of dyspnoea
Danish: Risiko for dyspnø
English: Ensure the bolus is completely administered before the start of PCI.
Danish: Kontrollér, at hele bolus administreres før start af PCI.
English: No effect on female fertility parameters were observed in animal studies of Kengrexal.
Danish: Der blev ikke observeret virkninger på kvindelige fertilitetsparametre i dyreforsøg med Kengrexal.
English: There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes.
Danish: Der findes ingen antidot mod Kengrexal, men Kengrexals farmakokinetiske halveringstid er 3-6 minutter.
English: Of the recovered material, 58% was found in urine and the remaining 35% was found in faeces, presumably following biliary excretion.
Danish: Af det genvundne materiale blev 58 % fundet i urin og de resterende 35 % i fæces, formodentlig efter udskillelse via galde.
English: * Including events with fatal outcome.
Danish: hændelser med letalt resultat.
English: • increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
Danish: • øget blodkreatinin i blodet (identificeret med blodprøver), hvilket er tegn på nedsat nyrefunktion,
English: Haematoma >5 cm
Danish: Hæmatom >5 cm
English: Hypersensitivity reactions may occur after treatment with Kengrexal.
Danish: Overfølsomhedsreaktioner kan forekomme efter behandling med Kengrexal.
English: Cerebral haemorrhage, cerebrovascular accident.
Danish: Cerebral blødning, cerebrovaskulær hændelse.