FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions listed below have been identified in publications of studies with amino acid solutions with the same composition with regards to the amino acid content, involving over 900 patients receiving more than 2,500 doses of arginine and lysine during PRRT with various radiolabelled somatostatin analogues.
Danish: Studierne involverede over 900 patienter, der modtog mere end 2.500 doser arginin og lysin under PRRT med forskellige radioaktivt mærkede somatostatinanaloger.
English: Each infusion bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
Danish: Hver infusionspose indeholder 25 g L-argininhydrochlorid og 25 g L-lysinhydrochlorid.
English: NAME OF THE MEDICINAL PRODUCT LysaKare 25 g/25 g solution for infusion
Danish: Indlægsseddel: Information til patienten LysaKare 25 g/25 g infusionsvæske, opløsning
English: As LysaKare is administered with lutetium (177Lu) oxodotreotide, please also refer to section 4.4 of the lutetium (177Lu) oxodotreotide SmPC for further warnings specific to treatment with lutetium (177Lu)
Danish: 4.4 i produktresumeet for lutetium (177Lu)-oxodotreotid for yderligere oplysninger vedrørende advarsler, som er specifikke for behandling med lutetium (177Lu)-oxodotreotid.
English: NAME OF THE MEDICINAL PRODUCT LysaKare 25 g/25 g solution for infusion L-arginine hydrochloride/L-lysine hydrochloride
Danish: LysaKare 25 g/25 g infusionsvæske, opløsning L-argininhydrochlorid/ L-lysinhydrochlorid
English: ANNEX II
Danish: Tabel 1
English: Talk to your doctor before taking LysaKare if your kidneys, heart or liver are severely impaired or if you have a history of high blood levels of potassium (hyperkalaemia).
Danish: Hvis din nyre-, hjerte- eller leverfunktion er svært nedsat, eller hvis du har en sygehistorie med høje niveauer af kalium i blodet (hyperkaliæmi) skal du fortælle det til lægen, før du får LysaKare.
English: oxodotreotide and dose limiting if amino acids are not administered to reduce renal uptake and retention.
Danish: Nyrerne er det mest udsatte organ for toksicitet i forbindelse med lutetium (177Lu)oxodotreotid, og toksiciteten er dosisbegrænsende, hvis der ikke administreres aminosyrer med henblik på at reducere optagelsen og tilbageholdelsen i nyrerne.
English: LIST OF EXCIPIENTS Excipient: water for injections
Danish: Hjælpestof: Vand til injektionsvæsker
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
Danish: En pose med 1.000 ml indeholder 25 g L-argininhydrochlorid og 25 g L-lysinhydrochlorid.
English: The doctor will check your blood potassium levels, and will correct them if they are too high before starting the infusion.
Danish: Hvis de er for høje, vil de blive korrigeret, inden infusionen af LysaKare påbegyndes.
English: 1,000 mL
Danish: Infusionsvæske, opløsning 1.000 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each bag of 1,000 mL contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
Danish: Hver pose med 1.000 ml indeholder 25 g L-argininhydrochlorid og 25 g L-lysinhydrochlorid.
English: How to store LysaKare
Danish: Hvis du har fået for meget LysaKare
English: Table 1 Adverse drug reactions
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: For other tests which need to be performed before your treatment, please read the Lutathera leaflet.
Danish: Læs indlægssedlen for Lutathera for information om andre tests, der skal udføres inden behandlingen.
English: LysaKare is indicated for administration with PRRT with lutetium (177Lu) oxodotreotide therefore, it should only be administered by a health care provider experienced in the use of PRRT.
Danish: Eftersom LysaKare administreres med lutetium (177Lu)-oxodotreotid, henvises der også til pkt.
English: - If you get any side effects, talk to your doctor.
Danish: - Kontakt lægen hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: It must not be used in women who are pregnant.
Danish: Det må ikke gives til kvinder, der er gravide.
English: • dementia (loss of intellectual function).
Danish: • Demens (tab af intellektuel funktion).
English: The risk caused by radioactivity is thought to be very low.
Danish: Risikoen som følge af radioaktiviteten anses for at være meget lille.
English: This summary was last updated in 04-2011.
Danish: Dette sammendrag blev sidst ajourført i 07-2010.
English: A scan is taken three to six hours after the injection.
Danish: Scanningen foretages tre til seks timer efter injektionen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for DaTSCAN to GE Healthcare Limited on 27 July 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for DaTSCAN til GE Healthcare Limited den 27. juli 2000.
English: The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Danish: Lægemidlet bruges ved diagnosticering af de følgende tilstande hos voksne (18 år eller derover):
English: This document is a summary of the European public assessment report (EPAR) for DaTSCAN.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for DaTSCAN.
English: In the larger of the two studies, the sensitivity of DaTSCAN was 97%.
Danish: I den største af de to undersøgelser var følsomheden af DaTSCAN 97 %.
English: ioflupane (123I)
Danish: ioflupan (123I)
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DaTSCAN.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for DaTSCAN.
English: DaTSCAN is only handled and given by people who have experience in the safe handling of radioactive materials.
Danish: DaTSCAN må kun håndteres og indgives af personer med erfaring i sikker håndtering af radioaktivt materiale.
English: Other information about DaTSCAN:
Danish: Andre oplysninger om DaTSCAN:
English: The CHMP decided that DaTSCAN's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved DaTSCAN er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for DaTSCAN.
English: If this happens, the amount of DaTSCAN attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Danish: Hvis dette er tilfældet, vil mængden af DaTSCAN, der binder sig til disse nerveceller, være stærkt nedsat, hvilket vil fremgå af scanningen.
English: In movement disorders, DaTSCAN has been studied in 254 adults in two main studies.
Danish: I forhold til bevægelsesforstyrrelser blev DaTSCAN undersøgt i to hovedundersøgelser af 254 voksne.
English: For more information about treatment with DaTSCAN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med DaTSCAN, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: DaTSCAN is for diagnostic use only.
Danish: DaTSCAN er udelukkende til diagnostisk brug.
English: In movement disorders, DaTSCAN was effective at detecting changes in the brain due to Parkinson's disease or related diseases.
Danish: I forhold til bevægelsesforstyrrelser var DaTSCAN effektiv til at spore ændringer i hjernen forårsaget af Parkinsons sygdom eller beslægtede sygdomme.
English: In dementia, the sensitivity of DaTSCAN in distinguishing dementia caused by Lewy bodies from other types of dementia ranged from 75 to 80%.
Danish: I forhold til demens lå følsomheden af DaTSCAN til at skelne Lewy body-demens fra andre typer demens på mellem 75 og 80 %.
English: DaTSCAN is given by slow injection lasting no less than 15 to 20 seconds into an arm vein.
Danish: DaTSCAN gives ved langsom injektion (mindst 15 til 20 sekunder) i en armvene.
English: • movement disorders such as those seen in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
Danish: • Bevægelsesforstyrrelser som dem, der ses ved Parkinsons sygdom og andre beslægtede sygdomme, hvor tab af nerveceller medfører tremor (rysten), gangforstyrrelser (problemer med at gå) og muskelstivhed.
English: In the studies, images obtained in 45 healthy volunteers were compared with those obtained in 180 patients with Parkinson's disease or related diseases, and in 29 patients with essential tremor.
Danish: I undersøgelserne blev billeder fra 45 raske forsøgspersoner sammenholdt med billeder fra 180 patienter med Parkinsons sygdom eller beslægtede sygdomme og 29 patienter med essentiel tremor.
English: Because tremor can also occur in ‘essential tremor' (tremor whose cause is unknown), DaTSCAN is used to help distinguish between essential tremor and diseases related to Parkinson's disease;
Danish: Da rysten også kan opstå som følge af ”essentiel tremor” (rysten af ukendt årsag), benyttes DaTSCAN til at skelne mellem essentiel tremor og sygdomme forbundet med Parkinsons sygdom.
English: DaTSCAN should not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other ingredients.
Danish: DaTSCAN bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for ioflupan eller andre af indholdsstofferne.
English: DaTSCAN should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Danish: DaTSCAN må kun anvendes til patienter, der er henvist af en læge med erfaring i behandling af bevægelsesforstyrrelser eller demens.
English: In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of nerve cells in the striatum containing dopamine.
Danish: Hos patienter med Parkinsons sygdom og beslægtede sygdomme samt patienter med Lewy bodydemens forekommer der typisk tab af nerveceller indeholdende dopamin i striatum.
English: Resuscitation equipment should be available before DaTSCAN is given, in case the patient has an allergic reaction.
Danish: DaTSCAN må kun gives, når der er genoplivningsudstyr tilgængeligt, hvis patienten skulle få en allergisk reaktion.
English: In dementia, DaTSCAN has been studied in one main study involving 288 adults who had been diagnosed with dementia with Lewy bodies or Alzheimer's disease, or another form of dementia.
Danish: I forhold til demens blev DaTSCAN undersøgt i én hovedundersøgelse af 288 voksne diagnosticeret med Lewy body-demens eller Alzheimers sygdom eller en anden form for demens.
English: Ioflupane attaches specifically to structures on the surface of nerve cell endings in the striatum that are responsible for the transport of dopamine.
Danish: Ioflupan bindes specifikt til strukturer på overfladen af de terminaler af nervecellerne i striatum, der er ansvarlige for transport af dopamin.
English: When DaTSCAN is injected, ioflupane (123I) is distributed through the body in the blood and accumulates in the striatum, where it attaches to the structures that transport dopamine.
Danish: Når DaTSCAN indsprøjtes, fordeler ioflupan (123I) sig i kroppen via blodet og samler sig i striatum, hvor det bindes til de strukturer, der transporterer dopamin.
English: This means that the disease identified by the doctor reading the images obtained using DaTSCAN matched the existing diagnosis of the patients in 97% of cases.
Danish: Det vil sige, at den diagnose, lægerne havde stillet ved hjælp af billeder optaget med DaTSCAN, i 97 % af tilfældene svarede til den diagnose, patienterne havde i forvejen.
English: This can be seen using a special imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Danish: Dette kan ses ved hjælp af en særlig billeddannelsesteknik, der kaldes enkeltfotonemissionstomografi (SPECT), som finder det radioaktive jod-123.
English: When receiving DaTSCAN, patients must also take another medicine, such as iodine tablets, to prevent their thyroid gland from taking up the iodine contained in DaTSCAN.
Danish: Når patienterne får DaTSCAN, skal de også have et andet lægemiddel, såsom jodtabletter, der forhindrer skjoldbruskkirtlen i at optage jod fra DaTSCAN.
English: This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.
Danish: Derved bliver det muligt at skelne sygdomme forbundet med Parkinsons sygdom fra essentiel tremor og at skelne Lewy body-demens fra Alzheimers sygdom.
English: In all of the studies, the main measure of effectiveness was the accuracy of the diagnosis based on the images from the scan compared with the diagnosis made by a specialist doctor.
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt ved at sammenligne diagnosen fra scanningen med en diagnose stillet af en speciallæge.
English: DaTSCAN is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Danish: DaTSCAN benyttes til at skelne mellem en form for demens, der kaldes "Lewy body-demens", og Alzheimers sygdom.
English: The active substance in DaTSCAN, ioflupane (123I), is a radiopharmaceutical.
Danish: Det aktive stof i DaTSCAN, ioflupan (123I), er et radioaktivt lægemiddel.
English: What is the risk associated with DaTSCAN?
Danish: Hvilken risiko er der forbundet med DaTSCAN?
English: This is taken one to four hours before DaTSCAN.
Danish: Dette lægemiddel skal tages én til fire timer før og igen 12 til 24 timer efter DaTSCAN.
English: DaTSCAN is a solution for injection that contains the active substance ioflupane (123I).
Danish: DaTSCAN er en injektionsvæske (opløsning), der indeholder det aktive stof ioflupan (123I).
English: For the full list of all side effects reported with DaTSCAN, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for DaTSCAN fremgår af indlægssedlen.
English: It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
Danish: Det bruges til at påvise tab af nerveceller i det område af hjernen, der kaldes striatum, særligt de nerveceller, der udskiller det kemiske signalstof dopamin.
English: It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of the chemical element iodine.
Danish: Det indeholder et stof kaldet ioflupan, der er mærket med 123I (jod-123), en radioaktiv form af grundstoffet jod.
English: Why has DaTSCAN been approved?
Danish: Hvorfor blev DaTSCAN godkendt?
English: The most common side effect with DaTSCAN (seen in between 1 and 10 patients in 100) is headache.
Danish: De hyppigste bivirkninger ved DaTSCAN (som ses hos mellem 1 og 10 patienter ud af 100) er øget appetit, hovedpine, myrekryb og svimmelhed.
English: What is DaTSCAN used for?
Danish: Hvad anvendes DaTSCAN til?
English: What benefit has DaTSCAN shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved DaTSCAN?
English: How has DaTSCAN been studied?
Danish: Hvordan blev DaTSCAN undersøgt?
English: What is DaTSCAN?
Danish: Hvad er DaTSCAN?
English: How is DaTSCAN used?
Danish: Hvordan anvendes DaTSCAN?
English: How does DaTSCAN work?
Danish: Hvordan virker DaTSCAN?
English: Packaging Content Package sizeWithdrawal period
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: Invented Name Strength Pharmaceutical Form
Danish: EU-nummer Handelsnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: EU Number
Danish: Tilbageholdelsestid
English: Pharmaceutical form Route of administration
Danish: Lægemiddelform Administration Emballage
English: If pain persists for more than 12 hours, the doctor should be consulted again.
Danish: Hvis smerten vedvarer længere end 12 timer, skal man henvende sig til lægen igen.
English: The vaccine was first studied in a number of laboratory studies in pigs.
Danish: Vaccinen blev først undersøgt i en række laboratorieundersøgelser hos svin.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given.
Danish: Utilsigtet selvinjektion kan medføre svære smerter og hævelse, navnlig hvis der injiceres i et led eller en finger - dette kan medføre tab af fingeren, medmindre der straks iværksættes lægelig behandling.
English: Porcine circovirus vaccine (inactivated)
Danish: Porcint circovirus-vaccine (inaktiveret)
English: The full EPAR for Porcilis PCV ID can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Porcilis PCV ID findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Porcilis PCV ID on 28 August 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Porcilis PCV ID den 28. august 2015.
English: The vaccine is given using a suitable needle-free device for injection into the skin.
Danish: Vaccinen gives med en passende nålefri anordning til injektion i huden.
English: The vaccine does not contain any live PCV2 so that it cannot cause disease.
Danish: Vaccinen indeholder ingen levende PCV2 og kan derfor ikke forårsage sygdom.
English: The withdrawal period for meat from pigs treated with Porcilis PCV ID is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Porcilis PCV ID, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: PCVDs are considered to have a severe impact on pig production.
Danish: PCVD-sygdomme anses for at have alvorlig betydning for svineproduktionen.
English: The laboratory studies showed that the vaccine had its full effect against PCV2 by two weeks and that protection lasted 23 weeks after vaccination.
Danish: Laboratorieundersøgelserne viste, at vaccinen havde fuld virkning mod PCV2 i løbet af to uger, og at beskyttelsen varede i 23 uger efter vaccinationen.
English: If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected.
Danish: Ved utilsigtet selvinjektion skal der straks søges søge lægehjælp, selv om den injicerede mængde er meget lille.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Porcilis PCV ID's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Porcilis PCV ID opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede dette veterinærlægemiddel for at kunne anbefale udstedelse af en markedsføringstilladelse og fastlægge anvendelsesbetingelserne.
English: The most common side effect with Porcilis PCV ID (seen in more than 1 in 10 pigs) is a short-lived local reaction with hard non-painful swellings up to 2 cm in diameter which disappear within about five weeks of vaccination.
Danish: Den hyppigste bivirkning ved Porcilis PCV ID (som kan optræde hos mere end 1 ud af 10 svin) er en kortvarig lokal reaktion med hård, ikke-smertefuld hævelse på op til 2 cm i diameter, som svinder i løbet af ca. fem uger efter vaccinationen.
English: This is a summary of the European public assessment report (EPAR) for Porcilis PCV ID.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Porcilis PCV ID.
English: The vaccine contains small amounts of a protein from PCV2.
Danish: Vaccinen indeholder en lille smule protein fra PCV2.
English: When Porcilis PCV ID is given to pigs, the animals' immune system recognises the virus protein as ‘foreign' and reacts by building up an active immune response.
Danish: Når Porcilis PCV ID gives til svin, registrerer dyrenes immunsystem virusproteinet som "fremmed" og reagerer ved at opbygge en aktiv immunrespons.
English: PCV2 infection is widespread and nearly all pig herds are infected with PCV2.
Danish: Smitte med PCV2 er udbredt, og næsten alle svinebesætninger er smittet med PCV2.
English: In all three studies average daily weight gain in the finishing period was significantly higher in the pigs vaccinated with Porcilis PCV ID compared with the non-vaccinated pigs.
Danish: I alle tre undersøgelser var den gennemsnitlige daglige tilvækst i opfedningsperioden væsentligt højere hos svin vaccineret med Porcilis PCV ID end hos ikke-vaccinerede svin.
English: Porcilis PCV ID is an emulsion containing mineral oil.
Danish: Porcilis PCV ID er en emulsion, der indeholder mineralsk olie.
English: Similarly PCV2 viraemia was significantly lower in the vaccinated pigs compared with non-vaccinated pigs.
Danish: Tilsvarende var PCV2-viræmi væsentligt lavere hos de vaccinerede svin end hos de ikke-vaccinerede svin.
English: Porcilis PCV ID is a vaccine.
Danish: Porcilis PCV ID er en vaccine.
English: Porcilis PCV ID contains the active substance porcine circovirus (PCV2) ORF2 subunit antigen.
Danish: Porcilis PCV ID indeholder det aktive stof porcint circovirus (PCV2) ORF2 subunit-antigen.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Porcilis PCV ID, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Porcilis PCV ID, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Porcilis PCV ID has also been investigated in three field studies involving pig farms where PCV2 infection was present.
Danish: Porcilis PCV ID er desuden undersøgt i tre feltundersøgelser i svinebesætninger, hvor der var PCV2infektion.
English: PCV2 is recognised as the primary cause of post-weaning multisystemic wasting syndrome (PMWS), but is also associated with a number of other conditions collectively known as porcine circovirus disease in Europe (PCVD) e.g porcine respiratory disease complex (PRDC), enteritis, reproductive disorders.
Danish: PCV2 er anerkendt som den vigtigste årsag til syndromet multisystemisk svaghed (kakeksi) efter fravænning (PMWS), men er desuden knyttet til en række andre sygdomme, der tilsammen i Europa betegnes porcint circovirus-sygdom (PCVD).
English: Porcilis PCV ID contains the adjuvant light mineral oil and dl-α-tocopheryl acetate to enhance the immune response.
Danish: Porcilis PCV ID indeholder let mineralsk olie og dl-α-tocopherylacetat for at forstærke immunreaktionen (adjuvantia).
English: This will help reduce the PCV2 viraemia, virus load in the lungs and lymphoid tissue and virus shedding.
Danish: Dette vil mindske PCV2-viræmi, virusbelastning i lungerne og lymfevævet og udskillelse af virus.
English: The vaccine is used to reduce viraemia (presence of the virus in the blood), virus load in the lungs and lymphoid tissues and virus shedding.
Danish: Vaccinen anvendes til at mindske indholdet af virus i blodet (viræmi), virusbelastning i lungerne og lymfevævet og udskillelse af virus.
English: Porcilis PCV ID is a veterinary vaccine against porcine circovirus type 2 (PCV2) infection in pigs.
Danish: Porcilis PCV ID er en veterinærvaccine mod porcint circovirus type (PCV2) hos svin.