FrancophonIA/ELRC3.0 huggingface dataset:
English: It was to be available as a concentrate to make a solution for infusion (drip) into a vein.
Danish: Det skulle have været leveret som et koncentrat til infusionsvæske, opløsning (drop i en vene).
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application for Docetaxel Sun for commercial reasons.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skete af kommercielle grunde.
English: How is Docetaxel Sun expected to work?
Danish: Hvordan forventes Docetaxel Sun at virke?
English: On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Docetaxel Sun til behandling af forskellige typer kræft.
English: The company had not carried out a study to demonstrate that Docetaxel Sun is bioequivalent to the reference medicine, because this is not required if the medicines are simple solutions that are given into a vein.
Danish: Virksomheden havde ikke gennemført nogen undersøgelse for at påvise, at Docetaxel Sun er bioækvivalent med referencelægemidlet, da dette ikke er påkrævet, hvis lægemidlerne er almindelige opløsninger, der indgives i en blodåre (to lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen).
English: Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016
Danish: EMA/396891/2016
English: This may help to reduce psychotic and manic symptoms and prevent them from returning.
Danish: Dette kan mindske de psykotiske og maniske symptomer og forhindre dem i at vende tilbage.
English: On 8 January 2016, Mylan S.A.S.
Danish: Den 8. januar 2016 meddelte Mylan S.A.S.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 January 2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Its exact mechanism of action is unknown, but it attaches to several types of receptors on nerve cells in the brain.
Danish: Dets nøjagtige virkningsmekanisme kendes ikke, men man ved, at det bindes til flere forskellige typer receptorer på nerveceller i hjernen.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the reason for withdrawal was identification of manufacturing issues.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes problemer med fremstillingen.
English: This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Danish: Det betyder, at Aripiprazole Mylan svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
English: The company informed the CHMP that there were no consequences for patients in clinical trials.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Aripiprazole Mylan.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Aripiprazole Mylan.
English: Aripiprazole Mylan was developed as a ‘generic medicine'.
Danish: Aripiprazole Mylan blev udviklet som et "generisk lægemiddel".
English: It was to be available as tablets (5, 10, 15 and 30 mg) and as 10 and 15 mg orodispersible tablets (tablets that dissolve in the mouth).
Danish: Aripiprazole Mylan forventedes at fås som tabletter (5, 10, 15 og 30 mg) og som tabletter der opløses i munden (smeltetabletter) (10 og 15 mg).
English: It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder.
Danish: Det forventedes desuden anvendt til behandling af moderate til svære maniske episoder og til forebyggelse af nye maniske episoder hos voksne, der har bipolar sygdom type I, og som tidligere har haft virkning af lægemidlet, og til behandling i op til 12 uger af moderate til svære maniske episoder hos patienter på 13 år og ældre med bipolar sygdom type I.
English: The CHMP considered that the tests to support a biowaiver were not acceptable.
Danish: CHMP fandt, at testene til støtte for afkald på en bioækvivalensundersøgelse ikke kunne godtages.
English: Aripiprazole Mylan was expected to be used to treat schizophrenia in patients aged 15 years or over.
Danish: Aripiprazole Mylan forventedes anvendt til behandling af skizofreni hos patienter over 15 år.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters.
Danish: Det betyder, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5hydroxytryptamin, men virkningen er svagere end af de naturlige neurotransmittere.
English: The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Aripiprazole Mylan, aripiprazol, er et antipsykotisk lægemiddel.
English: What is Aripiprazole Mylan?
Danish: Hvad er Aripiprazole Mylan?
English: Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify.
Danish: Da Aripiprazole Mylan er et generisk lægemiddel, havde virksomheden fremlagt resultaterne af undersøgelser hos forsøgspersoner for at vise, at Aripiprazole Mylan, 10 mg tabletter og 10 mg smeltetabletter, var bioækvivalente med de tilsvarende tabletter af referencelægemidlet, Abilify.
English: The CHMP considered that the dissolution tests required for the biowaiver had not been carried out according to existing recommendations and thus, bioequivalence for all the different strengths of tablets and orodispersible tablets had not been demonstrated.
Danish: CHMP fandt, at opløselighedstestene til støtte for afkald på en bioækvivalensundersøgelse ikke var udført i henhold til eksisterende anbefalinger, og at der derfor ikke var påvist bioækvivalens af alle de forskellige styrker af tabletterne og smeltetabletterne.
English: To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine.
Danish: For at støtte en ansøgning om afkald på en bioækvivalensundersøgelse fremlagde virksomheden desuden laboratorietest for at vise, at andre styrker af Aripiprazole Mylantabletter opløses på samme måde som referencelægemidlet.
English: Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder.
Danish: Virkningen af aripiprazol ændrer aktiviteten af dopamin og 5-hydroxytryptamin, som er abnorm ved skizofreni og bipolar sygdom.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.
Danish: officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Aripiprazole Mylan til behandling af skizofreni og behandling og forebyggelse af maniske episoder hos patienter med bipolar sygdom type I.
English: Aripiprazole Mylan is a medicine that contains the active substance aripiprazole.
Danish: Aripiprazole Mylan er et lægemiddel, der indeholder det aktive stof aripiprazol.
English: Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder.
Danish: På baggrund af gennemgangen af dataene var CHMP på tidspunktet for tilbagetrækningen af ansøgningen af den foreløbige opfattelse, at Aripiprazole Mylan ikke kunne være blevet godkendt til behandling af skizofreni eller til behandling og forebyggelse af maniske episoder ved bipolar sygdom type I.
English: What was Aripiprazole Mylan expected to be used for?
Danish: Hvad forventedes Aripiprazole Mylan anvendt til?
English: agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Danish: Aripiprazol menes at virke ved delvis stimulation (dvs. som en "partiel agonist") på receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin).
English: The biowaiver removes the need to repeat bioequivalence studies for all the other strengths of Aripiprazole Mylan tablets.
Danish: Derved er det unødvendigt at gentage bioækvivalensundersøgelserne for alle de øvrige tabletstyrker af Aripiprazole Mylan.
English: How is Aripiprazole Mylan expected to work?
Danish: Hvordan forventes Aripiprazole Mylan at virke?
English: This action disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that nerve cells use to communicate with neighbouring cells.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til naboceller ved hjælp af signalstoffer (neurotransmittere).
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Aripiprazole Mylan eller i programmer for anvendelse af Aripiprazole Mylan med særlig udleveringstilladelse?
English: *MU : Million Units
Danish: *MU: Million enheder
English: Do not use after the expiry date stated on the label.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
English: The use of supplementary supportive treatments improves prognosis.
Danish: Brugen af andre støttende behandlinger øger prognosen.
English: Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Danish: Tre separate 5-dages behandlinger skal indledes på dag 0, dag 14 og dag 60.
English: After injection it is quickly bound to specific receptors of a large variety of cells.
Danish: Efter injektion bindes det hurtigt til specifikke receptorer på mange forskellige celler.
English: Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006
Danish: Dato for første markedsføringstilladelse: 06.11.2001 / Dato for seneste fornyelse af markedsføringstilladelse: 21.11.2006
English: These parameters return to normal in the week following the last injection.
Danish: Disse parametre normaliseres inden for 1 uge efter den sidste injektion.
English: These clinical signs disappear within 7 days without any particular treatment.
Danish: De kliniske symptomer forsvinder efter 7 dage uden behandling.
English: Dogs and cats.
Danish: Hund og kat.
English: Purified gelatin of porcine origin
Danish: Renset gelatine af porcin oprindelse
English: EXP: {month/year}
Danish: EXP {måneder/år}
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: A slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase were observed very commonly in safety studies.
Danish: En let nedgang i hvide blodlegemer, blodplader og røde blodlegemer og stigning i koncentration af alanin aminotransferase var meget almindelige under studierne af sikkerheden.
English: Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
Danish: Interferon virker ikke direkte og specifikt på den patogene virus, men udøver sin virkning ved hæmning af de inficerede cellers interne syntesemekanismer.
English: No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders.
Danish: Der foreligger ingen oplysninger vedrørende fremkaldelse af langvarige bivirkninger for hunde og katte, specielt for autoimmune forstyrrelser.
English: Interaction with other medicinal products and other forms of interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion
English: Store in the original carton.
Danish: Opbevares i den originale emballage.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: Any person intending to import, sell, supply and/or use VIRBAGEN OMEGA must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende VIRBAGEN OMEGA, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/eller anvendelse finder sted.
English: In some cases, during treatment, the following transitory clinical signs may be observed in dogs and cats:
Danish: I nogle tilfælde, under behandlingen, kan følgende forbigående kliniske symptomer observeres hos hund og kat:
English: Such side effects have been described after multiple and long-term administration of type I interferon in man.
Danish: Disse bivirkninger er beskrevet efter flere og langvarig indgivelse af type I interferon til mennesker.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: Overdose (symptoms, emergency procedures, antidotes)
Danish: Overdosis (symptomer, nødforanstaltninger, modgift)
English: However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.
Danish: Da der ikke foreligger nogen oplysninger om mulige interaktioner mellem interferon og andre præparater, bør anden støttende behandling bruges forsigtigt og efter en grundig risiko/effekt-analyse.
English: After a tenfold overdose in both dog and cat the following clinical signs have been observed:
Danish: Efter en tidobbelt overdosering hos både hunde og katte er følgende kliniske symptomer observeret:
English: Szent Istvàn krt.11.II/21.
Danish: VIRBAC Hungary KFT Szent Istvàn krt.11.II/21.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation).
Danish: Replikationsmekanismen bliver stoppet hovedsagelig i celler, der er inficeret med virus, både ved ødelæggelse af mRNA og inaktivering af translationsproteiner (2'5' oligo-adenylat syntetaseaktivering).
English: For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered.
Danish: For hunde anbefales det derfor, at der ikke gives vacciner, indtil hunden ser ud til at være rask.
English: Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV).
Danish: Den nøjagtige virkemåde for interferon omega kendes ikke fuldt ud, men kan være en forstærkning specielt hos hunde af kroppens ikke-specifikke forsvar overfor parvovirose og hos katte mod retrovirosis fra katteslægten (FeLV, FIV).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Lyophilisate: white pellet.
Danish: Lyofilisat: hvid pellet.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Danish: Må ikke blandes med lægemidler til dyr undtaget solvens der leveres til brug med dette veterinærlægemiddel.
English: Sodium chloride Water for injections
Danish: Natriumklorid Vand til injektionsvæsker
English: Each dose of 1 ml contains:
Danish: Hver dosis af 1 ml indeholder:
English: Solvent: colourless liquid.
Danish: Solvens: farveløs væske.
English: 5 MU presentation:
Danish: 5 MU pakning:
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains:
Danish: ANGIVELSE AF AKTIVE STOFFER Hver dosis af 1 ml indeholder: Aktivt stof:
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: The product should be used with the accompanying solvent only.
Danish: Præparatet bør kun bruges med den medfølgende solvens.
English: Pregnancy and lactation
Danish: Drægtighed og laktation
English: In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
Danish: Hos katte, der er inficeret med FIV, var dødeligheden lav (5 %) og blev ikke påvirket af behandlingen.
English: Lyophilisate: white pellet Solvent: colourless liquid
Danish: Lyofilisat: hvid pellet Solvens: farveløs væske
English: The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/FIV infections.
Danish: Derfor kan det ikke udelukkes, at der forekommer autoimmune forstyrrelser for dyr der er i behandling, og skal overvejes i forhold til de risici, der er forbundet med FeLV/FIV infektioner.
English: Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Danish: Hund og kat: Det har vist sig, at fuld overholdelse af den anbefalede dosering er nødvendig for at opnå klinisk effekt.
English: Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
Danish: Omega interferon fra dyr af katteslægten, produceret ved gensplejsning, er et type I interferon i nær familie med alfa interferon.
English: Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.
Danish: Reduktion i dødelighed og kliniske tegn på parvovirose (enterisk form) hos hunde fra de er en måned gamle.
English: SPECIAL WARNING(S) Special warnings for each target species
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER Særlige advarsler for hver dyreart
English: • slight increase of respiratory rate
Danish: • let øgning af respirationsfrekvens
English: Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin.
Danish: Hætteglas af type I glas lukket med gummiprop af butylgummipolymer overfladebehandlet med en lak af fluorocarbonpolymer.
English: Cats: In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
Danish: Kat: I tilfælde af gentagne behandlinger af kroniske sygdomme i forbindelse med hepatitis, hjerte- og nyresvigt skal den tilsvarende sygdom monitoreres før behandling med VIRBAGEN OMEGA.
English: No information is available on the safety and efficacy from the concurrent use of this product with any vaccine.
Danish: Der foreligger ingen oplysninger vedrørende præparatets sikkerhed og effekt, hvis det anvendes sammen med vacciner.
English: In the case of intravenous administration in cats, increased adverse reactions may be seen, e.g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
Danish: Ved intravenøs administration hos katte kan øget forekomst af bivirkninger ses, som f.eks. hypertermi, blød fæces, anoreksi, nedsat tørst og kollaps.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr
English: No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents.
Danish: Der er ikke observeret interaktion i behandlingen med VIRBAGEN OMEGA og antibiotika, solvens mod dehydrering, vitaminer og ikkesteroide antiinflammatorisk stoffer.
English: Cat vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
Danish: Kattevaccination under og efter behandling med VIRBAGEN OMEGA er kontraindikeret, da både FeLV og FIV infektioner vides at være immunosuppressive.
English: Sodium hydroxide 0.2 M Sodium chloride D-Sorbitol
Danish: Natriumhydroxid 0,2 M Natriumklorid
English: • slight increase of body temperature.
Danish: • let øgning af kropstemperatur