FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is 20 mg once daily.
Danish: Til behandling af NSAID-associeret gastrisk og duodenalt ulcus er den anbefalede dosis 20 mg én gang dagligt.
English: For the treatment of symptomatic gastro-oesophageal reflux disease, the recommended dose is 20 mg daily.
Danish: Til behandling af symptomatisk gastroøsofageal reflukssygdom er den anbefalede dosis 20 mg dagligt.
English: In patients with poorly responsive duodenal ulcer 40 mg once daily is recommended and healing is usually achieved within four weeks.
Danish: Hos patienter med duodenalt ulcus, som reagerer dårligt på behandling, anbefales 40 mg én gang dagligt, og helbredelsen sker som regel inden for otte uger.
English: In patients with poorly responsive gastric ulcer 40 mg once daily is recommended and healing is usually achieved within eight weeks.
Danish: Hos patienter med gastrisk ulcus, som reagerer dårligt på behandling, anbefales 40 mg én gang dagligt, og helbredelsen sker som regel inden for otte uger.
English: The scope of the referral included all licences, whether prescription only (POM/Rx) or non-prescription (over-thecounter or OTC).
Danish: Indbringelsen omfattede alle tilladelser, både for receptpligtige lægemidler og for håndkøbslægemidler.
English: For the treatment of duodenal ulcers, the recommended dose is 20 mg once daily.
Danish: Til behandling af duodenalt ulcus er den anbefalede dosis 20 mg én gang dagligt.
English: Regarding the prevention of relapse of H. pylori negative duodenal ulcers, the available literature was reviewed.
Danish: Den tilgængelige litteratur vedrørende forebyggelse af tilbagefald af H. pylori-negative duodenale ulcera blev gennemgået.
English: For the treatment of gastric ulcers, the recommended dose is 20 mg once daily.
Danish: Til behandling af gastrisk ulcus er den anbefalede dosis 20 mg én gang dagligt.
English: The CHMP considered that the currently available information is not sufficient for a warning in the SPC, however, due to the concerns raised, the outcome of the proposed MAH epidemiological study on the risk of falls and fractures will be assessed in order to determine the implications for the Losec SPC.
Danish: Imidlertid vil udfaldet af den af indehaveren af markedsføringstilladelsen foreslåede epidemiologiske undersøgelse af risikoen for fald og frakturer blive vurderet for at påvise betydningen for produktresuméet for Losec.
English: It is in the so-called “idiopathic ulcers” that the prevention of relapse of H. pylori negative duodenal and gastric ulcer indications are indicated.
Danish: Forebyggelse af tilbagefald af H. pylori-negative duodenalt og gastrisk ulcusindikationer er indiceret ved såkaldte ”idiopatiske ulcera”.
English: For the treatment of reflux oesophagitis, the recommended dose is 20 mg once daily.
Danish: Til behandling af refluksøsofagitis er den anbefalede dosis 20 mg én gang dagligt.
English: A response is usually seen in two to four weeks.
Danish: Virkning kan sædvanligvis ses efter to til fire uger.
English: The full EPAR and risk management plan summary for Duloxetine Zentiva 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 Duloxetine Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duloxetine Zentiva.
English: The Committee recommended that Duloxetine Zentiva be approved for use in the EU.
Danish: Udvalget anbefalede, at Duloxetine Zentiva godkendes til anvendelse i EU.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Danish: Hos patienter, der har virkning af Duloxetine Zentiva, bør behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage, eller længere hos patienter, der tidligere har haft gentagne perioder med depression.
English: A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Duloxetine Zentiva anvendes så sikkert som muligt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, 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 Duloxetine Zentiva, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg).
Danish: Duloxetine Zentiva fås som enterokapsler (30 og 60 mg).
English: Duloxetine Zentiva contains the active substance duloxetine and is is a ‘generic medicine'.
Danish: Duloxetine Zentiva indeholder det aktive stof duloxetin og er et "generisk lægemiddel".
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af disse neurotransmittere i overgangen mellem nervecellerne og forbedrer derved kommunikationen mellem cellerne.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Danish: Til generaliseret angst er den anbefalede startdosis 30 mg én gang dagligt, men dosis kan sættes op til 60, 90 eller 120 mg, afhængigt af virkningen hos patienten.
English: This means that Duloxetine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Danish: Det betyder, at Duloxetine Zentiva svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
English: For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day.
Danish: Til svær depression er den anbefalede dosis af Duloxetine Zentiva 60 mg én gang dagligt.
English: Duloxetine Zentiva is used to treat adults with the following diseases:
Danish: Duloxetine Zentiva anvendes til behandling af voksne med følgende tilstande:
English: For more information about treatment with Duloxetine Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Duloxetine Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Duloxetine Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Cymbalta.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.
Danish: For patienter, hos hvem Duloxetine Zentiva virker, skal behandlingen fortsætte i flere måneder for at undgå tilbagevenden af sygdommen.
English: Other information about Duloxetine Zentiva
Danish: Andre oplysninger om Duloxetine Zentiva
English: What measures are being taken to ensure the safe and effective use of Duloxetine Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duloxetine Zentiva?
English: What are the benefits and risks of Duloxetine Zentiva?
Danish: Hvilke fordele og risici er der forbundet med Duloxetine Zentiva?
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day.
Danish: Til smerter forårsaget af sukkersygebetingede nervelidelser er den anbefalede dosis 60 mg dagligt, men nogle patienter kan have behov for en højere dosis på op til 120 mg dagligt.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);
Danish: • smerter ved sukkersygebetingede nervelidelser i fødder, ben, hænder og arme som følge af beskadigelse af nerverne (perifer diabetisk neuropati)
English: What is Duloxetine Zentiva and what is it used for?
Danish: Hvad er Duloxetine Zentiva, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Duloxetine Zentiva.
Danish: Det er ikke en praktisk vejledning i, hvordan Duloxetine Zentiva bør anvendes.
English: For practical information about using Duloxetine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Duloxetine Zentiva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because Duloxetine Zentiva 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 Duloxetine Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Duloxetine Zentiva duloxetine
Danish: Duloxetine Zentiva duloxetin
English: Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Duloxetine Zentiva er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet Cymbalta.
English: Why is Duloxetine Zentiva approved?
Danish: Hvorfor blev Duloxetine Zentiva godkendt?
English: The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.
Danish: Når behandlingen ophører, bør det ske gennem gradvis nedsættelse af dosis af Duloxetine Zentiva.
English: Since these neurotransmitters are involved in maintaining mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Når der blokeres for deres genoptagelse i nervecellerne, opnår patienten derfor en bedring i symptomerne på depression, angst og neuropatiske smerter.
English: How has Duloxetine Zentiva been studied?
Danish: Hvordan blev Duloxetine Zentiva undersøgt?
English: How is Duloxetine Zentiva used?
Danish: Hvordan anvendes Duloxetine Zentiva?
English: How does Duloxetine Zentiva work?
Danish: Hvordan virker Duloxetine Zentiva?
English: Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.
Danish: Oncaspar fik en markedsføringstilladelse med gyldighed i hele EU den 14. januar 2016.
English: Further information on Oncaspar can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR Oncaspar.
Danish: Yderligere information om Oncaspar findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR Oncaspar.
English: The healthcare professional should give the medicine in a hospital where resuscitation equipment is available.
Danish: Sundhedspersonerne bør give lægemidlet på et hospital, hvor der er genoplivningsudstyr til rådighed.
English: It contains the active substance pegaspargase.
Danish: Det indeholder det aktive stof pegaspargase.
English: As for all medicines, data on the use of Oncaspar are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Oncaspar løbende overvåget.
English: However, the data in adult patients were limited and the company that markets the medicine is to provide further data of its benefit in this group of patients.
Danish: For voksne patienter var data dog begrænsede, og den virksomhed, der markedsfører lægemidlet, skal fremlægge yderligere data om dets fordele hos denne patientgruppe.
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Danish: Normale celler kan derimod producere deres egen asparagin og påvirkes mindre af lægemidlet.
English: Other information about Oncaspar
Danish: Andre oplysninger om Oncaspar
English: This compares with 66% of those treated with another asparaginase.
Danish: Dette skal sammenholdes med 66 % af dem, der blev behandlet med et andet lægemiddel indeholdende asparaginase.
English: For more information about using Oncaspar, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Oncaspar, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Oncaspar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Oncaspar?
English: Oncaspar is used in combination with other cancer medicines.
Danish: Oncaspar anvendes i kombination med andre lægemidler.
English: Side effects reported with Oncaspar are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Oncaspar vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Oncaspar and why it is authorised in the EU
Danish: En oversigt over Oncaspar, og hvorfor det er godkendt i EU
English: Oncaspar also comes with the advantage of requiring fewer injections as the medicine stays longer in the body than some other asparaginases.
Danish: Oncaspar har desuden den fordel, at det kræver færre indsprøjtninger, da lægemidlet forbliver længere i kroppen end visse andre asparaginaser.
English: The European Medicines Agency therefore decided that Oncaspar's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Oncaspar opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Oncaspar can only be obtained with a prescription and only healthcare professionals with experience of cancer treatments should prescribe and give the medicine.
Danish: Oncaspar udleveres kun efter recept, og kun sundhedspersoner med erfaring i kræftbehandling bør ordinere og give lægemidlet.
English: The asparaginase enzyme in this medicine is linked to a chemical which slows down its removal from the body and can reduce the risk of allergic reactions.
Danish: Enzymet asparaginase i dette lægemiddel er bundet til et kemisk stof, der hæmmer dets udskillelse fra kroppen og kan nedsætte risikoen for allergiske reaktioner.
English: The company that markets Oncaspar will complete two more studies on the safety and effectiveness of Oncaspar, which will help further clarify the benefits and risks of this medicine in adults and in newly diagnosed patients.
Danish: Desuden skal den virksomhed, der markedsfører Oncaspar, gennemføre to yderligere studier af sikkerheden og virkningen af Oncaspar for yderligere at klarlægge fordelene og risiciene ved dette lægemiddel hos voksne og hos nydiagnosticerede patienter.
English: Oncaspar is normally given every 14 days by injection into a muscle or by infusion (drip) into a vein, with the dose depending on age and body surface area.
Danish: Oncaspar gives normalt hver 14. dag ved injektion i en muskel eller ved infusion (drop) i en vene, idet dosis afhænger af alder og legemsoverflade.
English: The most common side effects with Oncaspar (which may affect more than 1 in 10 people) include signs of liver problems (raised levels of liver enzymes and bilirubin in the blood), reduced blood clotting, high levels of fats in the blood, high levels of blood glucose and low levels of white blood cells accompanied by fever.
Danish: De hyppigste bivirkninger ved Oncaspar (som kan forekomme hos mere end 1 ud af 10 personer) omfatter tegn på leverproblemer (forhøjede lever-enzymer og bilirubin i blodet), reduceret størkning af blodet, højt indhold af fedt i blodet, højt blodsukkerniveau og et lavt niveau af hvide blodlegemer ledsaget af feber.
English: In a study in 118 children newly diagnosed with ALL, 75% of those treated with Oncaspar (in combination with other medicines) were free of the cancer after 7 years, without having relapse or a new cancer during that period.
Danish: I et studie, som omfattede 118 børn med nydiagnosticeret ALL, var 75 % af dem, der blev behandlet med Oncaspar (i kombination med andre lægemidler) fri for kræft efter 7 år uden tilbagefald eller ny
English: Why is Oncaspar authorised in the EU?
Danish: Hvorfor blev Oncaspar godkendt i EU?
English: What is Oncaspar and what is it used for?
Danish: Hvad er Oncaspar, og hvad anvendes det til?
English: Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to asparaginase.
Danish: Studierne viste, at Oncaspar er effektivt hos patienter med ALL, herunder patienter, der var allergiske over for andre lægemidler, der indeholder asparaginase.
English: Oncaspar is a cancer medicine used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts.
Danish: Oncaspar er et kræftlægemiddel til behandling af voksne og børn, der lider af akut lymfoblastær leukæmi (ALL), en kræftform udgående fra de hvide blodlegemer, der kaldes lymfoblaster.
English: Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis (including pancreatitis caused by previous asparaginase treatments) or patients who have had severe bleeding or serious blood clots following asparaginase treatment.
Danish: Oncaspar må ikke anvendes hos patienter med svær leversygdom, patienter, der har haft bugspytkirtelbetændelse (herunder bugspytkirtelbetændelse forårsaget af tidligere behandling med asparaginase), eller patienter, der har fået svære blødninger eller alvorlige blodpropper efter behandling med asparaginase.
English: What are the risks associated with Oncaspar?
Danish: Hvilke risici er der forbundet med Oncaspar?
English: As for its risks, the side effects of Oncaspar are similar to those of other asparaginase medicines and are considered manageable
Danish: Hvad angår risiciene, svarer bivirkningerne ved Oncaspar til bivirkningerne ved andre asparaginaselægemidler, og de kan behandles.
English: In another study of 76 children whose cancer returned after earlier treatment, around 40% of Oncaspar-treated patients (some of whom were allergic to other asparaginase treatments) were cleared of the cancer, compared with 47% of patients treated with an asparaginase comparator.
Danish: I et andet studie, som omfattede 76 børn, hvis kræft vendte tilbage efter tidligere behandling, blev omkring 40 % kræftfri af dem, der blev behandlet med Oncaspar (hvoraf nogle var allergiske over for andre asparaginase-lægemidler), sammenholdt med 47 % af dem, der blev behandlet med et sammenligningslægemiddel af asparaginasetypen.
English: The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Danish: Det aktive stof (pegaspargase) indeholder enzymet asparaginase, der virker ved at nedbryde aminosyren asparagin i blodet og derved nedsætte dens koncentration.
English: For the full list of side effects of Oncaspar, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Oncaspar fremgår af indlægssedlen.
English: How is Oncaspar used?
Danish: Hvordan anvendes Oncaspar?
English: What benefits of Oncaspar have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Oncaspar?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oncaspar 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 Oncaspar.
English: The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
Danish: Kræftcellerne behøver denne aminosyre for at vokse og formere sig.
English: How does Oncaspar work?
Danish: Hvordan virker Oncaspar?
English: The sooner treatment is started, the better the chances of survival.
Danish: Jo tidligere behandlingen indledes, desto større chance er der for overlevelse.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orfadin on 21 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orfadin den 21. februar 2005.
English: As the company had submitted the additional information requested, the ‘exceptional circumstances' ended on 21 September 2009.
Danish: Efter at virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de "særlige omstændigheder" ophævet den 21. september 2009.
English: This is a summary of the European public assessment report (EPAR) for Orfadin.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Orfadin.
English: With additional Orfadin treatment, the survival rate increases to 82%.
Danish: Ved supplerende behandling med Orfadin øges overlevelsesprocenten til 82 %.
English: Other information about Orfadin
Danish: Andre oplysninger om Orfadin
English: This is a programme through which doctors can request a medicine for one of their patients before the medicine is fully authorised.
Danish: Det er et program, hvorigennem læger kan anmode om udlevering af et lægemiddel til en af deres patienter, inden lægemidlet er godkendt fuldt ud.
English: It is available as capsules (2 mg, 5 mg, 10 mg and 20 mg) and as a suspension (4 mg/ml) to be taken by mouth.
Danish: Det fås som kapsler (2 mg, 5 mg, 10 mg og 20 mg) og som en suspension (4 mg/ml) til indtagelse gennem munden.
English: The recommended starting dose is 1 mg per kilogram body weight per day, divided into two doses.
Danish: Den anbefalede startdosis er 1 mg/kg legemsvægt pr. dag opdelt i to doser.
English: Orfadin nitisinone
Danish: Orfadin nitisinon
English: A risk management plan has been developed to ensure that Orfadin is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Orfadin anvendes så sikkert som muligt.
English: For example, a baby less than two months old with HT-1 would normally have only a 28% chance of surviving for five years using a modified diet alone.
Danish: F.eks. vil en baby, der er under to måneder gammel, og som lider af HT-1, normalt kun have 28 % chance for at overleve i 5 år, hvis der udelukkende anvendes en ændret diæt.
English: The largest study of Orfadin was carried out in 257 patients in 87 different hospitals in 25 countries, as part of a ‘compassionate-use' programme.
Danish: Den største undersøgelse af Orfadin omfattede 257 patienter fra 87 forskellige hospitaler i 25 lande og er et led i et program for anvendelse med særlig udleveringstilladelse.
English: Because the number of patients with HT-1 is low, the disease is considered ‘rare', and Orfadin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 December 2000.
Danish: Da antallet af patienter med HT-1 er lavt, betragtes sygdommen som "sjælden", og Orfadin blev udpeget som lægemiddel til sjældne sygdomme den 29. december 2000.
English: Many of these side effects can be the result of high tyrosine levels caused by patients not eating the right foods.
Danish: Mange af disse bivirkninger kan skyldes et for højt tyrosinniveau, som forekommer hos patienter, der ikke får den rette kost.