FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Pemetrexed Krka 500 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 500 mg rekonstitueres med 20 ml natriumchlorid-injektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Survival Time (months)
Danish: Survi Time (months)
English: Haemoglobin decreased 33.0* Neutrophils/Granulocyte s decreased
Danish: Nedsat hæmoglobin Nedsat neutrofiler/ granulocytter Nedsat leukocytter Nedsat trombocytter
English: Rash/desquamation
Danish: Udslæt/hudafskalning
English: Fully supplemented patients
Danish: Fuldt tilskud
English: Excipients
Danish: Adenocaidnoma
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Common Rash/desquamation
Danish: Almindelig Udslæt/hudafskalning
English: Grade 34 toxicity
Danish: Toksicitet i grad 3
English: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
Danish: Tel: + 386 (0) 1 47 51 100
English: How to use Pemetrexed Krka
Danish: Sådan skal du bruge Pemetrexed Krka
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8
Danish: For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-delen og 1,8 måneder for placebo-delen, hazard ratio = 0,47, 95 % CI = 0,37-0,60; p = 0,00001.
English: Loxicom received a marketing authorisation valid throughout the EU on 10 February 2009.
Danish: Loxicom modtog en markedsføringstilladelse med gyldighed i hele EU den 10. februar 2009.
English: Further information on Loxicom can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/loxicom.
Danish: Yderligere oplysninger om Loxicom findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/loxicom.
English: Injections may be into a vein, muscles or under the skin.
Danish: Injektionerne kan gives i en vene, i muskler eller under huden.
English: For the 20 mg/ml solution for injection the meat withdrawal period is five days, and for the 50 mg/ml oral paste it is three days.
Danish: I forbindelse med injektionsvæsken, 20 mg/ml, er tilbageholdelsestiden for kød fem dage, og for den orale pasta, 50 mg/ml, er den tre dage.
English: Other information about Loxicom
Danish: Andre oplysninger om Loxicom
English: As for every medicine, the company provided studies on the quality of Loxicom.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Loxicom.
English: Loxicom is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Danish: Loxicom er et antiinflammatorisk lægemiddel, der anvendes hos kvæg, svin, heste, hunde og katte.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Loxicom.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Metacam, og det er ikke nødvendigt at gentage disse med Loxicom.
English: What are the benefits and risks of Loxicom?
Danish: Hvilke fordele og risici er der forbundet med Loxicom?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Loxicom has been shown to have comparable quality and to be bioequivalent to Metacam.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Loxicom er af sammenlignelig kvalitet og er bioækvivalent med Metacam.
English: An overview of Loxicom and why it is authorised in the EU
Danish: En oversigt over Loxicom, og hvorfor det er godkendt i EU
English: Loxicom can only be obtained with a prescription.
Danish: Loxicom udleveres kun efter recept.
English: This means that Loxicom contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Danish: Det betyder, at Loxicom indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder Metacam.
English: The precautions are the same as for the reference medicine since Loxicom is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Loxicom er et generisk lægemiddel.
English: For meat the withdrawal period is five days.
Danish: Tilbageholdelsestiden for kød er fem dage.
English: What is Loxicom and what is it used for?
Danish: Hvad er Loxicom, og hvad anvendes det til?
English: Loxicom contains the active substance meloxicam and is a ‘generic medicine'.
Danish: Loxicom indeholder det aktive stof meloxicam og er et "generisk lægemiddel".
English: For further information about using Loxicom, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Loxicom, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Why is Loxicom authorised in the EU?
Danish: Hvorfor blev Loxicom godkendt i EU?
English: Because Loxicom 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 Loxicom er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Loxicom, 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 Loxicom, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Loxicom contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Loxicom indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikkesteroide antiinflammatoriske lægemidler (NSAID'er).
English: Therefore, the Agency's view was that, as for Metacam, the benefit of Loxicom outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Loxicom opvejer de identificerede risici som for Metacam, og at det kan godkendes til anvendelse i EU.
English: It can be used with oral re-hydration therapy (fluids given by mouth to restore water levels in the body) to reduce diarrhoea in calves of over one week of age and young, non-lactating cattle.
Danish: Det kan anvendes med oral rehydreringsbehandling (væsker, der indgives gennem munden for at genoprette væskebalancen i kroppen) med henblik på at mindske diarré hos kalve, der er mere end én uge gamle, og hos ungkvæg, som ikke er diegivende.
English: It can be used to relieve pain following dehorning in calves and to support the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Danish: Det kan anvendes til lindring af smerter ved afhorning af kalve og som tillægsbehandling ved behandling af akut yverbetændelse (mastitis) i kombination med antibiotika.
English: Loxicom is available as an oral (taken by mouth) suspension, oral paste, chewable tablets and a solution for injection.
Danish: Loxicom fås som en oral suspension (dvs. en suspension, som indtages gennem munden), oral pasta, tyggetabletter og en opløsning til injektion.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Danish: Loxicom virker ved at blokere et enzym kaldet cyclooxygenase, der medvirker ved dannelsen af prostaglandiner.
English: As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Danish: Prostaglandiner udløser betændelse, smerter og væskeudskillelse (ekssudation) fra blodkarrene under inflammation og feber, og meloxicam mindsker disse sygdomstegn.
English: In pigs, Loxicom is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move that are not caused by an infection) and to support together with appropriate antibiotic therapy the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Danish: Hos svin anvendes Loxicom til at reducere lammelse og betændelse i forbindelse med ikkesmittefarlige sygdomme i bevægeapparatet (sygdomme, som påvirker bevægelsesevnen, og som ikke skyldes betændelse), og som tillæg til passende antibiotikabehandling ved behandling af sygdomme, der opstår efter faring, såsom puerperal septikæmi og toksæmi (mastitis-metritis-agalactia-syndrom).
English: In cattle, Loxicom is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Danish: Hos kvæg anvendes Loxicom i kombination med passende antibiotikabehandling til at mindske de kliniske symptomer på akut respiratorisk infektion (betændelse i lunger og luftveje).
English: Moreover, it is used to lessen inflammation and pain in musculoskeletal disorders.
Danish: Det anvendes desuden til at mindske betændelse og smerter ved muskuloskeletale lidelser.
English: In horses, Loxicom is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Danish: Hos heste anvendes Loxicom til at mindske smerter forbundet med mavesmerter (kolik), mindske betændelse og lindre smerter i forbindelse med både akutte og kroniske muskuloskeletale lidelser (sygdomme, der berører musklerne og knoglerne).
English: How has Loxicom been studied?
Danish: Hvordan er Loxicom blevet undersøgt?
English: Moreover, it is used to lessen pain and inflammation in musculo-skeletal disorders.
Danish: Det anvendes desuden til at lindre smerter og reducere betændelse ved muskuloskeletale lidelser.
English: In cats, Loxicom is used to reduce pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Danish: Hos katte anvendes Loxicom til at mindske smerter og betændelse efter ovariehysterektomi (kastrationsindgreb), ortopædkirurgi og mindre bløddelskirurgi.
English: How is Loxicom used?
Danish: Hvordan anvendes Loxicom?
English: How does Loxicom work?
Danish: Hvordan virker Loxicom?
English: In dogs, Loxicom is used to reduce pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Danish: Hos hunde anvendes Loxicom til at mindske smerter og betændelse efter ortopædkirurgi (f.eks. operation i forbindelse med knoglebrud) og bløddelskirurgi.
English: Strength Pharmaceutical Form
Danish: Styrke
English: The average length of response was 8.3 months.
Danish: Den gennemsnitlige responsvarighed var 8,3 måneder.
English: This was switched to full marketing authorisation on 26 July 2017.
Danish: Dette blev ændret til en fuldgyldig markedsføringstilladelse den 26. juli 2017.
English: Further information on Zykadia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Zykadia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 450 mg (3 capsules) once a day taken with food at the same time each day.
Danish: Den anbefalede dosis er 450 mg (3 kapsler) én gang dagligt sammen med et måltid på samme tid hver dag.
English: Zykadia received a conditional marketing authorisation valid throughout the EU on 06 May 2015.
Danish: Zykadia fik en betinget markedsføringstilladelse med gyldighed i hele EU den 6. maj 2015.
English: In two of these studies, involving 303 patients, the medicine was not compared with any other treatment.
Danish: I to af disse studier, hvori der deltog 303 patienter, blev lægemidlet ikke sammenlignet med anden behandling.
English: Other information about Zykadia
Danish: Andre oplysninger om Zykadia
English: In the second study, the overall response rate was 41% (57 of 140 patients) and the average length of response was 10.6 months.
Danish: I det andet studie var den samlede responsrate 41 % (57 ud af 140 patienter), og responsen varede i gennemsnit 10,6 måneder.
English: The European Medicines Agency therefore decided that Zykadia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Zykadia opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: As for all medicines, data on the use of Zykadia are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Zykadia løbende overvåget.
English: Zykadia contains the active substance ceritinib.
Danish: Zykadia indeholder det aktive stof ceritinib.
English: Side effects reported with Zykadia are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Zykadia vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Zykadia, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Zykadia, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Zykadia can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Zykadia udleveres kun efter recept, og behandlingen skal indledes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: What measures are being taken to ensure the safe and effective use of Zykadia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zykadia?
English: An overview of Zykadia and why it is authorised in the EU
Danish: En oversigt over Zykadia og hvorfor det er godkendt i EU
English: Zykadia was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Danish: Der blev oprindeligt udstedt en "betinget godkendelse" for Zykadia, fordi der afventedes yderligere dokumentation om lægemidlet.
English: Why is Zykadia authorised in the EU?
Danish: Hvorfor blev Zykadia godkendt i EU?
English: What is Zykadia and what is it used for?
Danish: Hvad er Zykadia, og hvad anvendes det til?
English: In the third study in 231 patients, Zykadia was compared with standard chemotherapy (medicines to treat cancer).
Danish: I det tredje studie hos 231 patienter blev Zykadia sammenlignet med standardkemoterapi (kræftlægemidler).
English: Regarding safety, the adverse effects with Zykadia generally appeared manageable.
Danish: Hvad sikkerheden angår, så det ud til, at bivirkningerne ved Zykadia som regel kunne håndteres.
English: The most common side effects with Zykadia (which may affect 1 or more people in 10) are diarrhoea, nausea (feeling sick), vomiting, tiredness, abnormal liver tests, abdominal (belly) pain, decreased appetite, weight loss, constipation, rash, increases in the level of a waste product called creatinine in the blood (a possible sign of kidney problems), oesophageal disorder (problems affecting the food pipe) and anaemia (low levels of red blood cells).
Danish: De hyppigste bivirkninger ved Zykadia (som kan forekomme hos mere end 1 ud af 10 personer) er diarré, kvalme, opkastning, træthed, abnorme leverprøver, mavesmerter, nedsat appetit, vægttab, forstoppelse, udslæt, forhøjet indhold af affaldsproduktet kreatinin i blodet (kan være tegn på nyreproblemer), problemer med spiserøret og lavt antal røde blodlegemer (anæmi).
English: The most common severe reactions (which may affect 1 or more people in 20) are abnormal liver tests, tiredness, diarrhoea, nausea, vomiting and hyperglycaemia (high blood sugar).
Danish: De hyppigste alvorlige bivirkninger (som kan forekomme hos mere end 1 ud af 20 personer) er abnorme leverprøver, træthed, diarré, kvalme, opkast og hyperglykæmi (forhøjet blodsukker).
English: Zykadia has been shown to be effective at treating advanced, ALK-positive NSCLC in three main studies in patients whose disease progressed despite previous treatment with the medicine crizotinib:
Danish: Zykadia er påvist at være effektivt til behandling af fremskreden, ALK-positiv NSCLC i tre hovedstudier med patienter, hos hvem sygdommen var skredet frem trods tidligere behandling med lægemidlet crizotinib:
English: The active substance in Zykadia, ceritinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Danish: Det aktive stof i Zykadia, ceritinib, virker ved at blokere aktiviteten af ALK, hvorved kræftens vækst og udbredelse nedsættes.
English: Zykadia has been shown to be effective at treating patients whose disease progressed during or shortly after treatment with crizotinib and who currently have very limited treatment options, as well as patients who have not been treated before.
Danish: Zykadia er påvist at være effektivt til behandling af patienter, hvis sygdom var skredet frem under behandlingen med crizotinib eller kort tid derefter, og som på nuværende tidspunkt har meget få behandlingsmuligheder, samt ikke tidligere behandlede patienter.
English: In patients with ALK-positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Danish: Hos patienter med ALK-positiv NSCLC dannes en unormal form af ALK, der stimulerer kræftcellerne til at dele sig og vokse ukontrolleret.
English: What are the risks associated with Zykadia?
Danish: Hvilke risici er der forbundet med Zykadia?
English: The doctor may decide to reduce the dose or stop treatment temporarily if side effects occur.
Danish: Hvis der opstår bivirkninger, kan lægen beslutte at nedsætte dosis eller midlertidigt standse behandlingen.
English: Zykadia is a cancer medicine used on its own to treat adults with a type of lung cancer called nonsmall-cell lung cancer (NSCLC), when the disease is advanced.
Danish: Zykadia er et kræftlægemiddel, der anvendes alene til behandling af voksne med ikke-småcellet lungekræft (NSCLC), når sygdommen er fremskreden.
English: It is only used if the NSCLC is ‘ALKpositive', which means that the cancer cells have certain defects affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Danish: Det anvendes kun ved NSCLC, der er "ALKpositiv", dvs. at kræftcellerne har visse defekter i genet for proteinet ALK (anaplastisk lymfomkinase).
English: For the full list of side effects and restrictions with Zykadia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Zykadia fremgår af indlægssedlen.
English: Patients given Zykadia lived for an average of 16.6 months without their disease getting worse compared with 8.1 months in patients given standard chemotherapy.
Danish: De patienter, der fik Zykadia, levede i gennemsnit 16,6 måneder, uden at sygdommen blev værre, sammenholdt med 8,1 måneder for dem, der fik standardkemoterapi.
English: Results showed that patients given Zykadia lived for an average of 5.4 months without their disease getting worse (progression-free survival) compared with 1.6 months in patients given standard chemotherapy.
Danish: Resultaterne viste, at de patienter, der fik Zykadia, gennemsnitligt levede i 5,4 måneder, uden at sygdommen blev værre (progressionsfri overlevelse), sammenholdt med 1,6 måneder hos dem, som fik standardkemoterapi.
English: ALK belongs to a family of proteins called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them.
Danish: ALK er proteiner i familien receptortyrosinkinaser, der medvirker ved cellers vækst og ved dannelsen af nye blodkar, der forsyner dem.
English: In one study 56% of patients given Zykadia (92 of 163) were considered by the treating doctors to have shown a complete or partial response to the medicine.
Danish: I det ene studie vurderede de behandlende læger, at der var fuldstændig eller delvis respons på lægemidlet hos 56 % af de patienter, der fik Zykadia (92 ud af 163).
English: How is Zykadia used?
Danish: Hvordan anvendes Zykadia?
English: The presence of genetic defects affecting ALK (‘ALK-positive' status) has to be confirmed in advance by appropriate methods.
Danish: Det skal på forhånd med passende metoder være fastslået, at patienten har gendefekten for ALK (er "ALK-positiv").
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zykadia 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 Zykadia.
English: How does Zykadia work?
Danish: Hvordan virker Zykadia?
English: What benefits of Zykadia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zykadia?
English: Response to treatment was assessed using body scans and standardised criteria used for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Danish: Virkningen af behandlingen (responsen) blev vurderet ved hjælp af kropsskanning og standardiserede kriterier for organtumorer.
English: Zykadia has also been shown to be effective at treating patients who had not been treated before in a study in 376 patients.
Danish: I et studie med 376 patienter er Zykadia desuden påvist at være effektivt til behandling af ikke tidligere behandlede patienter.
English: This summary was last updated in March 2018.
Danish: Dette sammendrag blev sidst ajourført i marts 2018.
English: Sevohale1 (sevoflurane)
Danish: Sevohale1 (sevofluran)
English: The name of the medicine was changed to Sevohale on 29 July 2016.
Danish: Lægemidlets navn blev ændret til Sevohale den 29. juli 2016.
English: Other information about Sevohale
Danish: Andre oplysninger om Sevohale
English: 1 Previously known as Sevocalm
Danish: 1 Tidligere kendt som Sevocalm
English: Together, these combined actions result in loss of consciousness.
Danish: Til sammen medfører disse virkninger bevidstløshed.
English: What are the benefits and risks of Sevohale?
Danish: Hvilke fordele og risici er der forbundet med Sevohale?
English: Further information on Sevohale can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Sevohale findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.