FrancophonIA/ELRC3.0 huggingface dataset:
English: Complete blood cell counts with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Danish: Før behandlingen bør der udføres komplet blodstatus med differentialtælling og trombocyttal samt
English: - Put used syringes into the puncture-proof container and keep this container out of the reach and
Danish: - Anbring brugte medicinsprøjter i den særlige beholder til skarpe genstande, og opbevar
English: Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration
Danish: Dette kan være tilfældet hos patienter, der behandles med kraftig radioterapi eller kemoterapi, eller hvor en tumor
English: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Danish: LÆGEMIDLETS NAVN Filgrastim ratiopharm 48 mio.IE/0,8 ml injektions- og infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion
Danish: LÆGEMIDLETS NAVN Filgrastim ratiopharm 30 mio. IE/0,5 ml injektions- og infusionsvæske, opløsning
English: Sickle cell crisis has happened in some patients with Sickle Cell Disease who have been
Danish: Nogle patienter med seglcellesygdom har fået seglcellekrise efter behandling med
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG INDGIVELSESVEJ(E) Filgrastim ratiopharm 30 mio. IE/0,5 ml injektions- og infusionsvæske, opløsning
English: Filgrastim ratiopharm 30 MIU/0.5 ml: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml solution.
Danish: Hver ml af opløsning til injektion eller infusion indeholder 60 millioner internationale enheder [mio. IE] (600 mikrogram) filgrastim Filgrastim ratiopharm 30 mio. IE/0,5 ml: En fyldt injektionssprøjte indeholder 30 millioner internationale enheder [mio. IE] (300 mikrogram) filgrastim i 0,5 ml.
English: Then, if ANC remains > 1.0 x 109/l for 3 more
Danish: Hvis det absolutte neutrofiltal holder sig > 1,0 x
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG INDGIVELSESVEJ(E) Filgrastim ratiopharm 48 mio. IE/0,8 ml injektions- og infusionsvæske, opløsning
English: Do not use any Filgrastim ratiopharm that is left in the syringe.
Danish: Eventuelle rester af Filgrastim ratiopharm i sprøjten må ikke anvendes.
English: Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/l.
Danish: Hvis leukocyttallet stiger til > 70 x109/l, bør filgrastim seponeres eller doseringen reduceres.
English: - The active substance is filgrastim.
Danish: Filgrastim ratiopharm indeholder: - Aktivt stof: filgrastim.
English: Filgrastim ratiopharm and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Danish: Hvis De donerer stamceller til eget brug, er den sædvanlige dosis 0,5 til 1 million internationale enheder (mio. IE) pr. kg legemsvægt om dagen.
English: An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
Danish: Der sås en øget incidens af embryonal
English: - neutropenia in patients with HIV infection, - peripheral blood stem cell mobilisation.
Danish: - Almen sløjhed grundet lav mængde af hvide blodlegemer (kronisk neutropeni), - Til at øge dannelsen af stamceller i blodet (mobilisering af perifere blodstamceller).
English: What should I do before I give myself a subcutaneous injection of Filgrastim ratiopharm?
Danish: Sådan gør De Dem klar til at give Dem selv en subkutan injektion af Filgrastim ratiopharm Forsøg at give indsprøjtningen på omtrent samme tidspunkt hver dag.
English: 6.3 Shelf life
Danish: 5.3 Prækliniske sikkerhedsdata
English: How do I inject Filgrastim ratiopharm myself?
Danish: - Lægen har ordineret Filgrastim ratiopharm til Dem personligt.
English: White cells are important as they
Danish: Hvide blodlegemer spiller en vigtig rolle i bekæmpelse af infektioner.
English: Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Danish: Knogler, led, muskler og bindevæv
English: Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
Danish: Det frarådes at seponere filgrastim præmaturt, d.v.s. før tidspunktet for det
English: 0.375 ml (40 µg/ml) 1 pre-filled pen
Danish: 0,375 ml (40 µg/ml) 1 fyldt pen
English: 0.65 ml (200 µg/ml) 1 pre-filled pen
Danish: 0,65 ml (200 µg/ml) 1 fyldt pen
English: 0.65 ml (200 µg/ml) 4 pre-filled pens
Danish: 0,65 ml (200 µg/ml) 4 fyldte penne
English: 0.65 ml (200 µg/ml) 4 pre-filled syringes with needle guard
Danish: 0,65 ml (200 µg/ml) 4 fyldte injektionssprøjter med kanylebeskyttelse
English: 0.375 ml (40 µg/ml) 4 pre-filled syringes with needle guard
Danish: 0,375 ml (40 µg/ml) 4 fyldte injektionssprøjter med kanylebeskyttelse
English: 0.65 ml (200 µg/ml) 1 pre-filled syringe with needle guard
Danish: 0,65 ml (200 µg/ml) 1 fyldt injektionssprøjte med kanylebeskyttelse
English: 0.375 ml (40 µg/ml) 1 pre-filled syringe with needle guard
Danish: 0,375 ml (40 µg/ml) 1 fyldt injektionssprøjte med kanylebeskyttelse
English: The full EPAR and risk management plan summary for Aripiprazole Mylan Pharma 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 Aripiprazole Mylan Pharma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Pharmathen on 30 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aripiprazole Pharmathen den 30. juni 2015.
English: Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Danish: Aripiprazole Mylan Pharma fås som tabletter (5, 10, 15 og 30 mg) og udleveres kun på recept.
English: The name of the medicine was changed to Aripiprazole Mylan Pharma on 3 June 2016.
Danish: Lægemidlets navn blev ændret til Aripiprazole Mylan Pharma den 3. juni 2016.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Danish: Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en "partiel agonist") af receptorerne for neurotransmitterne dopamin og 5hydroxytryptamin (også kaldet serotonin).
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Mylan Pharma.
English: A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Mylan Pharma anvendes så sikkert som muligt.
English: In addition, the company that markets Aripiprazole Mylan Pharma will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Danish: Den virksomhed, der markedsfører Aripiprazole Mylan Pharma, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Mylan Pharma, 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 Aripiprazole Mylan Pharma, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Mylan Pharma is broken down in the body.
Danish: Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Mylan Pharma i kroppen.
English: The Committee recommended that Aripiprazole Mylan Pharma be approved for use in the EU.
Danish: Udvalget anbefalede, at Aripiprazole Mylan Pharma godkendes til anvendelse i EU.
English: Aripiprazole Mylan Pharma is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Danish: Aripiprazole Mylan Pharma anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, der tidligere har haft virkning af lægemidlet.
English: Because Aripiprazole Mylan Pharma 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 Aripiprazole Mylan Pharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Abilify.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
English: Aripiprazole Mylan Pharma is used in patients with the following mental illnesses:
Danish: Aripiprazole Mylan Pharma anvendes hos patienter med følgende psykiske sygdomme:
English: This means that Aripiprazole Mylan Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Danish: Det betyder, at Aripiprazole Zentiva svarer til et "referencelægemiddel", som allerede er godkendt i EU.
English: For more information about treatment with Aripiprazole Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Mylan Pharma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Aripiprazole Mylan Pharma, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Aripiprazole Mylan Pharma, aripiprazol, er et antipsykotisk lægemiddel.
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Mylan Pharma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Mylan Pharma?
English: What are the benefits and risks of Aripiprazole Mylan Pharma?
Danish: Hvilke fordele og risici er der forbundet med Aripiprazole Mylan Pharma?
English: Other information about Aripiprazole Mylan Pharma
Danish: Andre oplysninger om Aripiprazole Mylan Pharma
English: What is Aripiprazole Mylan Pharma and what is it used for?
Danish: Hvad er Aripiprazole Mylan Pharma, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Aripiprazole Mylan Pharma.
Danish: Det er ikke en praktisk vejledning i, hvordan Aripiprazole Mylan Pharma bør anvendes.
English: Aripiprazole Mylan Pharma is used in patients aged 15 years or over;
Danish: Aripiprazole Mylan Pharma anvendes til patienter over 15 år,
English: For practical information about using Aripiprazole Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Aripiprazole Mylan Pharma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Aripiprazole Mylan Pharma is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Danish: Aripiprazole Mylan Pharma anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger.
English: Previously known as Aripiprazole Pharmathen.
Danish: Tidligere kaldet Aripiprazole Pharmathen.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Danish: aripiprazol bevirker derfor, at hjerneaktiviteten bliver normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen.
English: Why is Aripiprazole Mylan Pharma approved?
Danish: Hvorfor blev Aripiprazole Mylan Pharma godkendt?
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and is a ‘generic medicine'.
Danish: Aripiprazole Mylan Pharma er et lægemiddel, der indeholder det aktive stof aripiprazol.
English: Aripiprazole Mylan Pharma aripiprazole
Danish: Aripiprazole Mylan Pharma1
English: How has Aripiprazole Mylan Pharma been studied?
Danish: Hvordan blev Aripiprazole Mylan Pharma undersøgt?
English: How is Aripiprazole Mylan Pharma used?
Danish: Hvordan anvendes Aripiprazole Mylan Pharma?
English: Because Aripiprazole Mylan Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Danish: Patientundersøgelserne har derfor kun skullet vise, at det er bioækvivalent med referencelægemidlet, Abilify.
English: How does Aripiprazole Mylan Pharma work?
Danish: Hvordan virker Aripiprazole Mylan Pharma?
English: A comprehensive review of the published data was provided.
Danish: Der blev forelagt en udtømmende gennemgang af de publicerede data.
English: The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Danish: Udvalget blev desuden anmodet om at fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages.
English: aureus (skin disease).
Danish: aureus (hudsygdomme).
English: Thus, it was possible for the animals to receive the indicated dose of antibiotic.
Danish: Det var således muligt for dyrene at få den indicerede dosis antibiotikum.
English: 17170 Amer SPAIN
Danish: 17170 Amer SPANIEN
English: No specific risk to animal health was identified.
Danish: Der blev ikke påvist specifik risiko for dyrs sundhed.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicant/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: Fluoroquinolones have been authorised for use in these species for many years.
Danish: Fluorquinoloner har været godkendt til anvendelse hos disse arter i mange år.
English: Grounds for maintaining the marketing authorisations
Danish: Begrundelse for opretholdelse af markedsføringstilladelserne
English: Resistance transmission has not been studied specifically in rabbits.
Danish: Resistensoverførsel er ikke specifikt undersøgt for kaniner.
English: These species account for 85% of the animal (meat) production whilst e.g. rabbits only account for 0.7% of the French animal production (EMA, 2011)6, France being one of the biggest rabbit producers in the EU.
Danish: Disse arter tegner sig for 85 % af den animalske (kød)produktion, mens f.eks. kaniner kun udgør 0,7 % af den franske animalske produktion (EMA, 2011)6, idet Frankrig er en af de største kaninproducenter i EU.
English: The treatment did not affect the estimated water consumption of animals (about 100 ml/kg body weight).
Danish: Behandlingen havde ingen indflydelse på dyrenes skønnede vandforbrug (ca. 100 ml/kg kropsvægt).
English: Of the strains examined, 86.67% were susceptible to enrofloxacin, 10% were intermediate and 3.33% were resistant.
Danish: Af de undersøgte stammer var 86,7 % følsomme for enrofloxacin, 10 % var intermediære, og 3,33 % var resistente.
English: A second pharmacokinetic study was carried out in order to confirm the dose.
Danish: Der blev udført endnu en farmakokinetisk undersøgelse til bekræftelse af doseringen.
English: • Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Danish: • Når det er muligt, bør fluorquinoloner kun anvendes efter forudgående følsomhedstestning.
English: • Official and local antimicrobial policies should be taken into account when the product is used.
Danish: • Officielle og lokale retningslinjer for brug af antibiotika bør følges ved produktets anvendelse.
English: Fluoroquinolones are also authorised for use in cattle, pigs and poultry.
Danish: Fluorquinoloner er endvidere godkendt til anvendelse hos kvæg, svin og fjerkræ.
English: Risk for public health
Danish: Risiko for folkesundheden
English: • Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Danish: • Fluorquinoloner bør forbeholdes behandling af kliniske tilstande, der har responderet dårligt eller forventes at respondere dårligt på andre klasser af antibiotika.
English: Horizontal and vertical resistance transmission in poultry and pigs has been studied taking into account the specific characteristic of each animal production (Petersen.
Danish: Den horisontale og vertikale resistensoverførsel hos fjerkræ og svin er undersøgt under hensyntagen til de særlige karakteristika af de pågældende dyreproduktioner (Petersen.
English: In summary it may be concluded that today there is sufficient susceptibility to allow adequate treatment against the target animal pathogen Pasteurella.
Danish: Sammenfattende kan det konkluderes, at følsomheden i dag er tilstrækkelig til at tillade adækvat behandling mod den patogene målorganisme Pasteurella.
English: The efficacy of the product has been demonstrated in a well conducted GCP compliant trial.
Danish: Produktets virkning er godtgjort i en veludført GCP-overensstemmende undersøgelse.
English: However, data indicates that in the long run treatment could result in a decrease of efficacy of the treatment of the disease in rabbits and thus it is important that use is limited to cases where it is clearly needed and should be combined with good husbandry practices.
Danish: Dataene viser dog, at behandlingen på langt sigt kan medføre et fald i virkningen af sygdomsbehandlingen hos kaniner, hvorfor det er vigtigt at begrænse anvendelsen til klart nødvendige tilfælde og at kombinere den med god avlspraksis.
English: There are no data available that would allow the Committee to estimate the risk for rabbits alone but it seems adequate to allow for the extrapolation of information from poultry and pigs.
Danish: Der foreligger ikke data, der giver udvalget mulighed for at vurdere risikoen for kaniner alene, men det forekommer fyldestgørende at ekstrapolere oplysninger fra fjerkræ og svin.
English: Gran Via Carlos III 98 - 7ª 08028 Barcelona SPAIN
Danish: Gran Via Carlos III 98 - 7ª 08028 Barcelona SPANIEN
English: Therefore, there are no data available to characterise the risk to public health specifically linked to intake of rabbit meat or contact with food producing rabbits.
Danish: Der findes derfor ikke oplysninger, der specifikt karakteriserer risikoen for folkesundheden ved indtagelse af kaninkød eller kontakt med fødevareproducerende kaniner.
English: The pharmacokinetic/pharmacodynamic relationship was discussed in relation to the dosage regimens for the clinical trials provided.
Danish: Den farmakokinetiske/farmakodynamiske sammenhæng blev drøftet i forbindelse med dosisregimerne i de forelagte kliniske undersøgelser.
English: A less well characterised and possibly slightly higher risk as compared to other species could be acceptable in case of a minor species.
Danish: En mindre velkarakteriseret og måske lidt større risiko end for andre arter kan anses for acceptabelt for en mindre betydningsfuld dyreart.
English: Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Danish: Kaniner avles i kontinuerlige systemer, hvor resistente bakterier med tiden kan være persistente, men den samlede risiko vil være lav på grund af det lave forbrug af kaninkød.
English: Restrictions on availability of antimicrobials for rabbits may cause animal health and welfare concerns.
Danish: Begrænsning i adgangen til antibiotika til kaniner kan medføre risici for dyrenes sundhed og velfærd.
English: The prudent use recommendations and warnings that are listed in the product information for these products should be strictly followed and the products should not be used as a first line treatment.
Danish: Produktinformationens anbefalinger og advarsler om hensigtsmæssig brug af disse produkter bør overholdes nøje, og produkterne bør ikke være førstevalgsbehandling.
English: The products are authorised for use in the target species chickens, turkeys and rabbits.
Danish: Produkterne er godkendt til anvendelse i måldyrearterne kyllinger, kalkuner og kaniner.
English: Risk to public health due to spread of resistant bacteria from treated animals Data from the RESAPATH 2009 and 2010 annual reports (French surveillance network for antimicrobial resistance in pathogenic bacteria of animal origin) were provided.
Danish: Risiko for folkesundheden på grund af spredning af resistente bakterier fra behandlede dyr Der blev forelagt data fra årsberetningerne for 2009 og 2010 fra RESAPATH (det franske overvågningsnetværk for antimikrobiel resistens af patogene bakterier af animalsk oprindelse).
English: In addition this process seems to be immediate which means that the overall time during which faeces of rabbits are exposed to enrofloxacin during treatment is not significantly higher than without the coprophagy practice.
Danish: Denne proces synes desuden at foregå øjeblikkeligt, hvilket betyder, at den samlede tid, hvor kaninens fæces eksponeres for enrofloxacin under behandlingen, ikke er nævneværdigt højere, end den ville være uden koprofagi.
English: In relation to the first risk, the use of fluoroquinolones is identified as a risk factor for spread of MRSA but this would be an issue mainly in case of high prevalence of MRSA in animals and/or close contact between animals and humans.
Danish: Hvad angår den første risiko er anvendelse af fluorquinoloner udpeget som en risikofaktor for spredning af MRSA, men vil hovedsagelig være et problem ved høj forekomst af MRSA hos dyrene og/eller tæt kontakt mellem dyr og mennesker.
English: Regarding S. aureus, 89% (2009) and 82% (2010) of the bacterial isolates were susceptible to enrofloxacin.
Danish: Af S. aureus var 89 % (2009) og 82 % (2010) af isolaterne følsomme for enrofloxacin.
English: Several MIC data on P. multocida isolated from clinical samples from 30 Spanish rabbit farms in 2006 and 2007 were provided.
Danish: Der blev forelagt flere sæt MIC-data for P. multocida, der var isoleret fra kliniske prøver fra 30 spanske kaninfarme i 2006 og 2007.