natgillin/translations-raw huggingface dataset:
Eventuelle rester af Filgrastim ratiopharm i sprøjten må ikke anvendes.
Do not use any Filgrastim ratiopharm that is left in the syringe.
Hvis leukocyttallet stiger til > 70 x109/l, bør filgrastim seponeres eller doseringen reduceres.
Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/l.
Filgrastim ratiopharm indeholder: - Aktivt stof: filgrastim.
- The active substance is filgrastim.
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.
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.
Der sås en øget incidens af embryonal
An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
- Almen sløjhed grundet lav mængde af hvide blodlegemer (kronisk neutropeni), - Til at øge dannelsen af stamceller i blodet (mobilisering af perifere blodstamceller).
- neutropenia in patients with HIV infection, - peripheral blood stem cell mobilisation.
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.
What should I do before I give myself a subcutaneous injection of Filgrastim ratiopharm?
5.3 Prækliniske sikkerhedsdata
6.3 Shelf life
- Lægen har ordineret Filgrastim ratiopharm til Dem personligt.
How do I inject Filgrastim ratiopharm myself?
Hvide blodlegemer spiller en vigtig rolle i bekæmpelse af infektioner.
White cells are important as they
Knogler, led, muskler og bindevæv
Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Det frarådes at seponere filgrastim præmaturt, d.v.s. før tidspunktet for det
Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
0,375 ml (40 µg/ml) 1 fyldt pen
0.375 ml (40 µg/ml) 1 pre-filled pen
0,65 ml (200 µg/ml) 1 fyldt pen
0.65 ml (200 µg/ml) 1 pre-filled pen
0,65 ml (200 µg/ml) 4 fyldte penne
0.65 ml (200 µg/ml) 4 pre-filled pens
0,65 ml (200 µg/ml) 4 fyldte injektionssprøjter med kanylebeskyttelse
0.65 ml (200 µg/ml) 4 pre-filled syringes with needle guard
0,375 ml (40 µg/ml) 4 fyldte injektionssprøjter med kanylebeskyttelse
0.375 ml (40 µg/ml) 4 pre-filled syringes with needle guard
0,65 ml (200 µg/ml) 1 fyldt injektionssprøjte med kanylebeskyttelse
0.65 ml (200 µg/ml) 1 pre-filled syringe with needle guard
0,375 ml (40 µg/ml) 1 fyldt injektionssprøjte med kanylebeskyttelse
0.375 ml (40 µg/ml) 1 pre-filled syringe with needle guard
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.
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aripiprazole Pharmathen den 30. juni 2015.
The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Pharmathen on 30 June 2015.
Aripiprazole Mylan Pharma fås som tabletter (5, 10, 15 og 30 mg) og udleveres kun på recept.
Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Lægemidlets navn blev ændret til Aripiprazole Mylan Pharma den 3. juni 2016.
The name of the medicine was changed to Aripiprazole Mylan Pharma on 3 June 2016.
Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en "partiel agonist") af receptorerne for neurotransmitterne dopamin og 5hydroxytryptamin (også kaldet serotonin).
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Mylan Pharma.
This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Mylan Pharma anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma is used as safely as possible.
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.
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.
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.
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.
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Mylan Pharma i kroppen.
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.
Udvalget anbefalede, at Aripiprazole Mylan Pharma godkendes til anvendelse i EU.
The Committee recommended that Aripiprazole Mylan Pharma be approved for use in the EU.
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.
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.
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.
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.
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.
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.
Aripiprazole Mylan Pharma anvendes hos patienter med følgende psykiske sygdomme:
Aripiprazole Mylan Pharma is used in patients with the following mental illnesses:
Det betyder, at Aripiprazole Zentiva svarer til et "referencelægemiddel", som allerede er godkendt i EU.
This means that Aripiprazole Mylan Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
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.
For more information about treatment with Aripiprazole Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Aripiprazole Mylan Pharma, aripiprazol, er et antipsykotisk lægemiddel.
The active substance in Aripiprazole Mylan Pharma, aripiprazole, is an antipsychotic medicine.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Mylan Pharma?
What measures are being taken to ensure the safe and effective use of Aripiprazole Mylan Pharma?
Hvilke fordele og risici er der forbundet med Aripiprazole Mylan Pharma?
What are the benefits and risks of Aripiprazole Mylan Pharma?
Andre oplysninger om Aripiprazole Mylan Pharma
Other information about Aripiprazole Mylan Pharma
Hvad er Aripiprazole Mylan Pharma, og hvad anvendes det til?
What is Aripiprazole Mylan Pharma and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Aripiprazole Mylan Pharma bør anvendes.
It is not intended to provide practical advice on how to use Aripiprazole Mylan Pharma.
Aripiprazole Mylan Pharma anvendes til patienter over 15 år,
Aripiprazole Mylan Pharma is used in patients aged 15 years or over;
Hvis du ønsker praktisk vejledning om anvendelsen af Aripiprazole Mylan Pharma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Aripiprazole Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
Aripiprazole Mylan Pharma anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger.
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.
Tidligere kaldet Aripiprazole Pharmathen.
Previously known as Aripiprazole Pharmathen.
aripiprazol bevirker derfor, at hjerneaktiviteten bliver normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen.
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.
Hvorfor blev Aripiprazole Mylan Pharma godkendt?
Why is Aripiprazole Mylan Pharma approved?
Aripiprazole Mylan Pharma er et lægemiddel, der indeholder det aktive stof aripiprazol.
Aripiprazole Mylan Pharma contains the active substance aripiprazole and is a ‘generic medicine'.
Hvordan blev Aripiprazole Mylan Pharma undersøgt?
How has Aripiprazole Mylan Pharma been studied?
Hvordan anvendes Aripiprazole Mylan Pharma?
How is Aripiprazole Mylan Pharma used?
Patientundersøgelserne har derfor kun skullet vise, at det er bioækvivalent med referencelægemidlet, Abilify.
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.
Hvordan virker Aripiprazole Mylan Pharma?
How does Aripiprazole Mylan Pharma work?
Der blev forelagt en udtømmende gennemgang af de publicerede data.
A comprehensive review of the published data was provided.
Udvalget blev desuden anmodet om at fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages.
The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
aureus (hudsygdomme).
aureus (skin disease).
Det var således muligt for dyrene at få den indicerede dosis antibiotikum.
Thus, it was possible for the animals to receive the indicated dose of antibiotic.
17170 Amer SPANIEN
17170 Amer SPAIN
Der blev ikke påvist specifik risiko for dyrs sundhed.
No specific risk to animal health was identified.
Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
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
Fluorquinoloner har været godkendt til anvendelse hos disse arter i mange år.
Fluoroquinolones have been authorised for use in these species for many years.
Begrundelse for opretholdelse af markedsføringstilladelserne
Grounds for maintaining the marketing authorisations
Resistensoverførsel er ikke specifikt undersøgt for kaniner.
Resistance transmission has not been studied specifically in rabbits.
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.
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.
Behandlingen havde ingen indflydelse på dyrenes skønnede vandforbrug (ca. 100 ml/kg kropsvægt).
The treatment did not affect the estimated water consumption of animals (about 100 ml/kg body weight).
Af de undersøgte stammer var 86,7 % følsomme for enrofloxacin, 10 % var intermediære, og 3,33 % var resistente.
Of the strains examined, 86.67% were susceptible to enrofloxacin, 10% were intermediate and 3.33% were resistant.
Der blev udført endnu en farmakokinetisk undersøgelse til bekræftelse af doseringen.
A second pharmacokinetic study was carried out in order to confirm the dose.
• Når det er muligt, bør fluorquinoloner kun anvendes efter forudgående følsomhedstestning.
• Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
• Officielle og lokale retningslinjer for brug af antibiotika bør følges ved produktets anvendelse.
• Official and local antimicrobial policies should be taken into account when the product is used.
Fluorquinoloner er endvidere godkendt til anvendelse hos kvæg, svin og fjerkræ.
Fluoroquinolones are also authorised for use in cattle, pigs and poultry.
Risiko for folkesundheden
Risk for public health
• Fluorquinoloner bør forbeholdes behandling af kliniske tilstande, der har responderet dårligt eller forventes at respondere dårligt på andre klasser af antibiotika.
• 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.
Den horisontale og vertikale resistensoverførsel hos fjerkræ og svin er undersøgt under hensyntagen til de særlige karakteristika af de pågældende dyreproduktioner (Petersen.
Horizontal and vertical resistance transmission in poultry and pigs has been studied taking into account the specific characteristic of each animal production (Petersen.
Sammenfattende kan det konkluderes, at følsomheden i dag er tilstrækkelig til at tillade adækvat behandling mod den patogene målorganisme Pasteurella.
In summary it may be concluded that today there is sufficient susceptibility to allow adequate treatment against the target animal pathogen Pasteurella.
Produktets virkning er godtgjort i en veludført GCP-overensstemmende undersøgelse.
The efficacy of the product has been demonstrated in a well conducted GCP compliant trial.
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.
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.
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.
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.
Gran Via Carlos III 98 - 7ª 08028 Barcelona SPANIEN
Gran Via Carlos III 98 - 7ª 08028 Barcelona SPAIN
Der findes derfor ikke oplysninger, der specifikt karakteriserer risikoen for folkesundheden ved indtagelse af kaninkød eller kontakt med fødevareproducerende kaniner.
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.
Den farmakokinetiske/farmakodynamiske sammenhæng blev drøftet i forbindelse med dosisregimerne i de forelagte kliniske undersøgelser.
The pharmacokinetic/pharmacodynamic relationship was discussed in relation to the dosage regimens for the clinical trials provided.
En mindre velkarakteriseret og måske lidt større risiko end for andre arter kan anses for acceptabelt for en mindre betydningsfuld dyreart.
A less well characterised and possibly slightly higher risk as compared to other species could be acceptable in case of a minor species.
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.
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.
Begrænsning i adgangen til antibiotika til kaniner kan medføre risici for dyrenes sundhed og velfærd.
Restrictions on availability of antimicrobials for rabbits may cause animal health and welfare concerns.
Produktinformationens anbefalinger og advarsler om hensigtsmæssig brug af disse produkter bør overholdes nøje, og produkterne bør ikke være førstevalgsbehandling.
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.
Produkterne er godkendt til anvendelse i måldyrearterne kyllinger, kalkuner og kaniner.
The products are authorised for use in the target species chickens, turkeys and rabbits.
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).
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.
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.
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.
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.
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.
Af S. aureus var 89 % (2009) og 82 % (2010) af isolaterne følsomme for enrofloxacin.
Regarding S. aureus, 89% (2009) and 82% (2010) of the bacterial isolates were susceptible to enrofloxacin.
Der blev forelagt flere sæt MIC-data for P. multocida, der var isoleret fra kliniske prøver fra 30 spanske kaninfarme i 2006 og 2007.
Several MIC data on P. multocida isolated from clinical samples from 30 Spanish rabbit farms in 2006 and 2007 were provided.
Vedrørende den anden risiko - spredning af resistente zoonotiske bakterier og resistensgener via fødevarer - er denne risiko velkarakteriseret og blev i november 2006 genstand for en anbefaling fra CVMP om foranstaltninger til risikonedsættelse7.
Regarding the second risk, spread of resistant zoonotic bacteria and resistance genes via food, this is a well characterised risk for which CVMP in November 2006 recommended risk mitigation measures7.
Enrofloxacin er et antibiotikum tilhørende fluorquinolonerne, der af WHO er klassificeret som kritisk vigtige for menneskers sundhed ("Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009").
The enrofloxacin is an antimicrobial belonging to the class of fluoroquinolones, which are listed by the WHO as a critically important class of antimicrobials for human health (Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009).
Anvendelsen af fluorquinoloner hos kaniner kan derfor medføre større risiko for udvikling af antimikrobiel resistens, men der er tale om en teoretisk risiko.
The use of fluoroquinolones in rabbits may therefore have a higher risk on development of antimicrobial resistance, however this risk is theoretical.
Det er meget vigtigt, at anvendelse af sådanne antibiotika i veterinær- og humanmedicin finder sted i henhold til principperne om ansvarlig brug, dels for at bevare stoffernes virkning, dels for at mindske udviklingen og spredningen af antimikrobiel resistens til det mindst mulige.
It is very important that those antimicrobials are used in veterinary and human medicine according to responsible use principles to safeguard the efficacy of these substances and minimise the development of and dissemination of antimicrobial resistance.
Spredning af MRSA vil derfor først og fremmest forekomme fra svin (høj forekomst) og selskabsdyr (nær kontakt).
The species for which spread of MRSA would be important is therefore mainly swine (high prevalence) and companion animals (close contact).
Uheldigvis er det ikke tilstrækkeligt oplyst, hvilke kriterier der er lagt til grund for fortolkningen af årsberetningerne fra RESAPATH.
Unfortunately, there is insufficient information on the interpretation criteria used on the RESAPATH annual reports.
Risiko for dyrs sundhed
Risk to animals health
Ud fra administrationsmetoden kan det konkluderes, at risikoen ved behandling af kaniner svarer til risikoen ved behandling af fjerkræ.
From the route of administration it can be concluded that the risk of rabbit treatment would be similar to that of poultry.
Det kan derfor antages at anvendelsen af enrofloxacin hos kaniner ikke væsentligt øger den samlede anvendelse af enrofloxacin i EU, sammenholdt med dets anvendelse hos andre dyrearter.
Therefore it could be considered that the use of enrofloxacin in rabbits should not significantly increase overall use of enrofloxacin in the EU when compared to its use in other animal species.
Der blev foretaget følsomhedsbestemmelse af en række stammer af P. multocida i Spanien mellem 2009 og 2011, og antibiogrammet viste, at samtlige 61 testede isolater af P. multocida var følsomme.
Sensitivity of various strains of P. multocida was analysed in Spain between 2009 and 2011 and the antibiogram results showed that of a total of 61 P. multocida isolates all 61 strains were sensitive.
Af ovenstående grunde fandt udvalget det ikke rimeligt at tilbagekalde eller afslå godkendelse af disse produkter til kaniner, da det vil få negativ indvirkning på tilgængeligheden af midler til behandling af luftvejssygdomme i denne mindre betydningsfulde dyreart i tilfælde, hvor andre antibiotika ikke kan anvendes eller ikke er tilstrækkeligt effektive.
Taking into account the above reasoning the Committee considered that withdrawing or not authorising the use of these products in rabbit was considered not proportionate as this would create a negative impact on the availability of tools to treat respiratory diseases in this minor species, in cases when other antibiotics cannot be used or would not be sufficiently effective.