FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine Hexal must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Danish: Rivastigmine Hexal bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rivastigmin, andre stoffer afledt af carbamat eller andre af indholdsstofferne.
English: The active substance in Rivastigmine Hexal, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Rivastigmine Hexal, rivastigmin, er et middel til behandling af demens.
English: The global symptom score also improved more in the patients taking Rivastigmine Hexal.
Danish: Også i score vedrørende overordnede funktioner var der større bedring hos de patienter, der fik Rivastigmine Hexal.
English: The CHMP concluded that Rivastigmine Hexal has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine Hexal på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
English: The patients with dementia due to Parkinson's disease taking Rivastigmine Hexal capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Danish: Af de patienter, der havde demens som følge af Parkinsons sygdom, gav Rivastigmine Hexal-kapsler en bedring i de kognitive symptomer på 2,1 points, sammenholdt med en forværring på 0,7 points hos dem, der fik placebo.
English: What is the risk associated with Rivastigmine Hexal?
Danish: Hvilken risiko er der forbundet med Rivastigmine Hexal?
English: All of the studies lasted six months and compared the effects of Rivastigmine Hexal with those of placebo (a dummy treatment).
Danish: I dem alle blev virkningerne af Rivastigmine Hexal sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: In the three studies of Rivastigmine Hexal in patients with Alzheimer's dementia, patients taking doses of Rivastigmine Hexal between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Danish: Hos de patienter, der fik Rivastigmine Hexal, 6 til 9 mg dagligt, øgedes de kognitive symptomer med 0,2 points fra et udgangspunkt på 22,9 points ved undersøgelsens start (lavere score = bedre præstationer).
English: Why has Rivastigmine Hexal been approved?
Danish: Hvorfor blev Rivastigmine Hexal godkendt?
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine Hexal's benefits did not outweigh its risks.
Danish: Udvalget konkluderede først, at fordelene ved Rivastigmine Hexal ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
English: The types of side effects seen with Rivastigmine Hexal depend on the type of dementia it is being used to treat.
Danish: Bivirkningerne af Rivastigmine Hexal afhænger af den form for demens, patienten har.
English: Rivastigmine Hexal is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Det kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: What is Rivastigmine Hexal?
Danish: Hvad er Rivastigmine Hexal?
English: How has Rivastigmine Hexal been studied?
Danish: Hvordan blev Rivastigmine Hexal undersøgt?
English: What benefit has Rivastigmine Hexal shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rivastigmine Hexal?
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Danish: Hos de patienter, der fik placebo, var der en stigning på 2,6 points fra et udgangspunkt på 22,5.
English: For the global score, patients taking Rivastigmine Hexal had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Danish: For score vedrørende overordnede funktioner var der en stigning på 4,1 points hos patienterne på Rivastigmine Hexal.
English: By blocking these enzymes, Rivastigmine Hexal allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Rivastigmine Hexal hjernens indhold af acetylcholin.
English: How is Rivastigmine Hexal used?
Danish: Hvordan anvendes Rivastigmine Hexal?
English: What is Rivastigmine Hexal used for?
Danish: Hvad anvendes Rivastigmine Hexal til?
English: How does Rivastigmine Hexal work?
Danish: Hvordan virker Rivastigmine Hexal?
English: It is given once every three weeks as an infusion lasting 10 minutes.
Danish: Det gives én gang hver tredje uge ved en infusion, der varer 10 minutter.
English: Other information about Ciambra
Danish: Andre oplysninger om Ciambra
English: The full EPAR and risk management plan summary for Ciambra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Ciambra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ciambra is a ‘generic medicine'.
Danish: Ciambra er et "generisk lægemiddel".
English: This is a summary of the European public assessment report (EPAR) for Ciambra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ciambra.
English: The Committee recommended that Ciambra be approved for use in the EU.
Danish: Udvalget anbefalede, at Ciambra godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Ciambra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ciambra anvendes så sikkert som muligt.
English: Ciambra contains the active substance pemetrexed.
Danish: Ciambra indeholder det aktive stof pemetrexed.
English: Ciambra is a cancer medicine used to treat two types of lung cancer:
Danish: Ciambra er et kræftlægemiddel til behandling af to typer af lungekræft:
English: This means that Ciambra is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Danish: Det betyder, at Ciambra svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Alimta.
English: What are the benefits and risks of Ciambra?
Danish: Hvilke fordele og risici er der forbundet med Ciambra?
English: What is Ciambra and what is it used for?
Danish: Hvad er Ciambra, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ciambra has been shown to be comparable to Alimta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ciambra er sammenligneligt med Alimta.
English: What measures are being taken to ensure the safe and effective use of Ciambra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ciambra?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ciambra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ciambra, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: No additional studies were needed as Ciambra is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Danish: Der var ikke brug for yderligere undersøgelser, da Ciambra er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Danish: • fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekarcinom, hvor det anvendes enten i kombination med cisplatin hos tidligere ubehandlede patienter eller som eneste behandling hos patienter, der tidligere har fået kræftbehandling.
English: It is not intended to provide practical advice on how to use Ciambra.
Danish: Det er ikke en praktisk vejledning i, hvordan Ciambra bør anvendes.
English: Because Ciambra is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ciambra er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why is Ciambra approved?
Danish: Hvorfor er Ciambra blevet godkendt?
English: The active substance in Ciambra, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Danish: Det aktive stof i Ciambra, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Ciambra.
Danish: For at mindske bivirkningerne bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12 under behandlingen med Ciambra.
English: For more information about treatment with Ciambra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ciambra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: For practical information about using Ciambra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ciambra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When Ciambra is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Ciambra gives sammen med cisplatin, bør der desuden før eller efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
English: Ciambra is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Ciambra fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How has Ciambra been studied?
Danish: Hvordan er Ciambra blevet undersøgt?
English: How is Ciambra used?
Danish: Hvordan anvendes Ciambra?
English: How does Ciambra work?
Danish: Hvordan virker Ciambra?
English: 400 mg Powder for concentrate for solution for infusion
Danish: 400 mg pulver til koncentrat til infusionsvæske, opløsning
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse hætteglas af glas
English: Content (concentration)
Danish: MF (EU)-nummer
English: Movymia teriparatide
Danish: Movymia teriparatid
English: The full EPAR for Movymia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Movymia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Danish: Det øger også optagelsen af kalcium fra fødevarer og forebygger, at der går for meget kalcium tabt i urinen.
English: This is a summary of the European public assessment report (EPAR) for Movymia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Movymia.
English: This means that Movymia is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Movymia svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Movymia must not be used during pregnancy or breastfeeding.
Danish: Movymia må ikke anvendes under graviditet og amning.
English: Other information about Movymia
Danish: Andre oplysninger om Movymia
English: The two-year course of Movymia should be given only once during a patient's lifetime.
Danish: Det to-årige behandlingsforløb med Movymia må kun gives én gang i løbet af en patients livstid.
English: A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body.
Danish: En undersøgelse af 54 raske kvinder har vist, at de samme doser af de to lægemidler givet som injektion under huden medførte samme niveauer af det aktive stof teriparatid i kroppen.
English: This was considered sufficient to conclude that Movymia will behave in the same way in terms of effectiveness and safety.
Danish: Udvalget anså dette for tilstrækkeligt til at konkludere, at Movymia vil optræde på samme måde med hensyn til virkning og sikkerhed.
English: • men who are at an increased risk of fractures;
Danish: • mænd med en øget risiko for knoglebrud
English: What measures are being taken to ensure the safe and effective use of Movymia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Movymia?
English: Movymia contains the active substance teriparatide.
Danish: Movymia indeholder det aktive stof teriparatid.
English: The most common side effect with Movymia (seen in more than 1 patient in 10) is pain in the arms or legs.
Danish: Den hyppigste bivirkning med Movymia (som ses hos flere end 1 ud af 10 behandlede) er smerter i arme eller ben.
English: The reference medicine for Movymia is Forsteo.
Danish: Referencelægemidlet for Movymia er Forsteo.
English: Further, Movymia and Forsteo produced similar effects on calcium levels in the blood.
Danish: Desuden havde både Movymia og Forsteo samme virkning på kalciumniveauet i blodet.
English: • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Danish: • mænd og kvinder med en øget risiko for knoglebrud på grund af langvarig behandling med binyrebarkhormoner (en type steroider).
English: Movymia must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Danish: Movymia må ikke anvendes hos patienter, der har andre knoglesygdomme, som f.eks. Pagets sygdom, knoglekræft eller knoglemetastaser (kræft, der har bredt sig til knoglerne), patienter, som har fået stråleterapi på knoglerne, eller patienter, som har hyperkalcæmi (højt kalciumindhold i blodet), eller som har forhøjet alkalisk phosphatase (et enzym) af ukendte årsager eller svær nyresygdom.
English: Why is Movymia approved?
Danish: Hvorfor blev Movymia godkendt?
English: Movymia is a ‘biosimilar medicine'.
Danish: Movymia er et "biosimilært" lægemiddel.
English: What is Movymia and what is it used for?
Danish: Hvad er Movymia, og hvad anvendes det til?
English: What are the risks associated with Movymia?
Danish: Hvilke risici er der forbundet med Movymia?
English: It is not intended to provide practical advice on how to use Movymia.
Danish: Det er ikke en praktisk vejledning i, hvordan Movymia bør anvendes.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Knogleskørhed opstår, når der ikke dannes tilstrækkelig knoglemasse til at erstatte den knoglemasse, som naturligt nedbrydes.
English: For more information about treatment with Movymia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Movymia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended dose is 20 micrograms of Movymia given once a day as an injection under the skin of the thigh or abdomen (belly).
Danish: Den anbefalede dosis af Movymia er 20 mikrogram givet én gang dagligt som en injektion under huden i låret eller på maven.
English: Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Movymia can be used for up to two years.
Danish: Patienterne bør tage kalcium- og D-vitamintilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Movymia has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) gennemgik materiale, der viste, at Movymia har en struktur, renhed og biologisk aktivitet, som i høj grad minder om Forsteos, og stoffet fordeles i kroppen på samme måde.
English: Movymia is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system.
Danish: Movymia fås som en injektionsvæske, opløsning, i cylinderampuller (med 600 mg mikrogram teriparatid) beregnet til anvendelse med ServoPen Fix-systemet.
English: Gradually, the bones become less dense and more likely to break.
Danish: Knoglerne bliver gradvis tynde og skrøbelige, og sandsynligheden for brud øges.
English: It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Danish: Ligesom hormonet virker det ved at stimulere knogledannelse gennem dets virkning på de knogledannende celler (osteoblaster).
English: Patients may inject themselves once they have been trained.
Danish: Når patienterne har fået undervisning, kan de selv foretage injektionen.
English: Laboratory studies comparing Movymia with Forsteo have shown that the active substance in Movymia is highly similar to that in Forsteo in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenlignede Movymia med Forsteo, har vist, at det aktive stof i Movymia minder meget om Forsteo, hvad angår struktur, renhed og biologisk aktivitet.
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Danish: Hos kvinder er knogleskørhed mere almindelig efter overgangsalderen, hvor indholdet af det kvindelige kønshormon østrogen falder.
English: For practical information about using Movymia, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Movymia, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Movymia, teriparatide, is identical to part of the human parathyroid hormone.
Danish: Det aktive stof i Movymia, teraparatid, er identisk med det menneskelige paratyroideahormon.
English: Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.
Danish: Knogleskørhed kan også forekomme som bivirkning til behandling med binyrebarkhormoner hos mænd og kvinder.
English: Movymia is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:
Danish: Movymia er et lægemiddel til behandling af knogleskørhed (osteoporose) hos:
English: For the full list of all side effects reported with Movymia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Movymia fremgår af indlægssedlen.
English: • women who have been through the menopause.
Danish: • kvinde efter overgangsalderen.
English: Because Movymia is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not need to be repeated for Movymia.
Danish: Movymia er et biosimilært lægemiddel, og det har derfor ikke været nødvendigt at gennemføre undersøgelser af Movymias virkning og sikkerhed, da det aktive stof, teriparatid, allerede er undersøgt for Forsteo.
English: How does Movymia work?
Danish: Hvordan virker Movymia?
English: In these patients, Movymia has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Danish: Det er påvist, at Movymia hos disse patienter i væsentlig grad reducerer forekomsten af brud på rygsøjlen og øvrige knoglebrud med undtagelse af hoftebrud
English: What benefits of Movymia have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Movymia?
English: How is Movymia used?
Danish: Hvordan anvendes Movymia?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Movymia have 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 Movymia.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Movymia on 11 January 2017.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Movymia.
English: Thus, as for Forsteo, the benefit outweighs the identified risks and the Committee recommended that Movymia be given marketing authorisation.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Forsteo.
English: The product information was amended accordingly.
Danish: Produktinformationen blev ændret i overensstemmelse hermed.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: It was however acknowledged that in some patients a lower dose of 5mg could be effective.
Danish: Det erkendtes dog, at en lavere dosis på 5 mg kunne være effektiv hos nogle patienter.
English: Grounds for the PRAC recommendation
Danish: Begrundelse for PRAC's anbefaling
English: The currently recommended daily dose in the elderly and in patients with hepatic impairment is 5mg, and this dose recommendation remains unchanged in the product information.
Danish: Den aktuelt anbefalede dagsdosis til ældre og patienter med nedsat leverfunktion er 5 mg, og denne dosis forbliver uændret i produktinformationen.
English: The PRAC therefore agreed that the recommended daily dose of zolpidem should not be reduced for adults.
Danish: PRAC fandt derfor, at den anbefalede dagsdosis af zolpidem ikke burde nedsættes for voksne.
English: Therefore in July 2013, AIFA requested the PRAC to give a recommendation under Article 31 of Directive 2001/83/EC on whether marketing authorisation of these products should be maintained, varied, suspended, or withdrawn.
Danish: AIFA anmodede derfor i juli 2013 PRAC om at fremsætte en udtalelse i henhold til artikel 31 i direktiv 2000/83/EF om, hvorvidt markedsføringstilladelserne for disse lægemidler burde opretholdes, ændres, suspenderes eller inddrages.