FrancophonIA/ELRC3.0 huggingface dataset:
English: Inactivated Bordetella bronchiseptica, strain 833CER: ........................................9.8 BbCC(*) Recombinant Type D Pasteurella multocida toxin (PMTr): ............................ ≥ 1 MED63(**) (*) Bordetella bronchiseptica Cell Count in log10.
Danish: Inaktiveret Bordetella bronchiseptica, stamme 833CER: ...................................... 9,8 BbCC(*) Rekombinant Type D Pasteurella multocida-toksin (PMTr): ........................... ≥ 1 MED63(**) (*) Bordetella bronchiseptica-celletal i log10.
English: Inactivated Bordetella bronchiseptica, strain 833CER: ............................................ 9.8 BbCC Recombinant Type D Pasteurella multocida toxin (PMTr): ................................... ≥ 1 MED63
Danish: Inaktiveret Bordetella bronchiseptica, stamme 833CER: .......................................... 9,8 BbCC Rekombinant Type D Pasteurella multocida-toksin (PMTr): .................................. ≥ 1 MED63
English: Shelf life after first opening the immediate packaging: 10 hours stored at room temperature.
Danish: Opbevaringstid efter første åbning af den indre emballage: 10 timer ved opbevaring ved stuetemperatur.
English: (**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63% of the animals.
Danish: (**) Murin Effektiv Dosis 63: subkutan vaccination af mus med 0,2 ml af en 5 gange fortyndet vaccine bevirker en serokonversion hos mindst 63% af dyrene.
English: RHINISENG suspension for injection for pigs.
Danish: RHINISENG injektionsvæske, suspension til grise.
English: 20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and aluminium cap.
Danish: Flasker af polyethylen (PET) a 20 ml, 50 ml, 100 ml og 250 ml lukket med en gummiprop og aluminiumshætte.
English: Basic vaccination: sows and gilts which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Danish: Der indgives en dosis på 2 ml ved intramuskulær injektion i halsmusklerne ifølge nedenstående skema: Grundvaccination: søer og gylte, som ikke tidligere er vaccineret med produktet, skal gives to injektioner med 3-4 ugers mellemrum.
English: For passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Danish: Til passiv beskyttelse af smågrise via kolostrum efter aktiv immunisering af søer og gylte for at reducere de kliniske tegn og læsioner forårsaget af progressiv og non-progressiv atrofisk rhinitis (nysesyge), samt for at reducere det vægttab, der ledsager infektioner med Bordetella bronchiseptica og Pasteurella multocida, i opvækstperioden.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE AND VIAL LABEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET PÅ FLASKE OG HÆTTEGLAS
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTONÆSKE
English: Type II colourless glass vials of 50 ml and 100 ml .
Danish: Farveløse type I-hætteglas a 20 ml Farveløse type II-hætteglas a 50 ml og 100 ml
English: Formaldehyde .................................................................................................................. 0.8 mg For the full list of excipients, see section 6.1.
Danish: Formaldehyd .................................................................................................................... 0,8 mg Hvid, homogen suspension
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF (FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at necropsy in 10% of animals.
Danish: Hos 10% af dyrene iagttages der ved obduktion en misfarvning af muskelfibrene på inokuleringsstedet (0,5 cm i bredden x 2 cm i længden).
English: Store and transport refrigerated (2 °C to 8 °C).
Danish: Opbevares og transporteres nedkølet (2°C - 8°C) Beskyttes mod lys.
English: Tel. +34 972 430660
Danish: Tlf. +34 972 430660
English: Pack sizes: - Cardboard box with 1 or 10 glass vials of 10 doses.
Danish: Pakningsstørrelser: - Kartonæske med 1 eller 10 hætteglas a 10 doser.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af selvindgivelse ved hændeligt uheld forventes kun en mindre reaktion på injektionsstedet.
English: EXP {month/ year} Once opened, use within a 10-hour period, stored at 15 ºC to 25 ºC.
Danish: {måned/år} Efter anbrud, anvendes inden for en periode på 10 timer ved opbevaring mellem 15 og 25°C.
English: PACKAGE LEAFLET: RHINISENG suspension for injection for pigs
Danish: RHINISENG injektionsvæske, suspension til grise
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 ºC to 25 ºC.
Danish: Opbevaringstid efter anbrud af den indre emballage: 10 timer ved opbevaring mellem 15 og 25ºC.
English: - Cardboard box with 1 or 10 PET bottles of 10 doses.
Danish: - Kartonæske med 1 eller 10 PET-flasker a 10 doser.
English: Vaccinate only healthy animals.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Kun raske dyr bør vaccineres.
English: - Cardboard box with 1 PET bottle of 125 doses.
Danish: - Kartonæske med 1 PET-flaske a 125 doser.
English: Adjuvants:
Danish: INDLÆGSSEDDEL:
English: Name and address of the manufacturer
 responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse Laboratorios Hipra, S.A.
English: - Cardboard box with 1 PET bottle of 50 doses.
Danish: - Kartonæske med 1 PET-flaske a 50 doser.
English: - Cardboard box with 1 PET bottle of 25 doses.
Danish: - Kartonæske med 1 PET-flaske a 25 doser.
English: - Cardboard box with 1 glass vial of 25 doses.
Danish: - Kartonæske med 1 hætteglas a 25 doser.
English: Name and address of the manufacturer of the biological active substances
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer) Laboratorios Hipra, S.A.
English: - Cardboard box with 1 glass vial of 50 doses.
Danish: - Kartonæske med 1 hætteglas a 50 doser.
English: Store and transport refrigerated.
Danish: Opbevares og transporteres nedkølet Beskyttes mod lys.
English: The company that applied for authorisation is Portola Pharma UK Limited.
Danish: Den virksomhed, der søgte om tilladelse, er Portola Pharma UK Limited.
English: It was to be available as capsules.
Danish: Det skulle markedsføres som kapsler.
English: EMA/501901/2018EMA/501901/2018EMEA/H/C/004309
Danish: EMA/501901/2018 EMEA/H/C/004309
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial.
Danish: Hvis du deltager i et klinisk studie og har behov for mere information om din behandling, kan du kontakte den forsøgslæge, der behandler dig.
English: Refusal of the marketing authorisation for Dexxience (betrixaban)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Dexxience (betrixaban)
English: What was Dexxience expected to be used for?
Danish: Hvad forventedes Dexxience anvendt til?
English: Dexxience is a medicine that contains the active substance betrixaban.
Danish: Dexxience er et lægemiddel, der indeholder det aktive stof betrixaban.
English: Refusal of the marketing authorisation for Dexxience (betrixaban) EMA/501901/2018
Danish: Afslag på ansøgningen om markedsføringstilladelse for Dexxience (betrixaban) EMA/501901/2018
English: The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness.
Danish: Virksomheden fremlagde resultaterne af ét hovedstudie med deltagelse af mere end 7 500 voksne, som var blevet indlagt på hospital på grund af en nylig sygdom.
English: What is Dexxience?
Danish: Hvad er Dexxience?
English: It was to be used in adults admitted to hospital for the treatment of a recent medical illness.
Danish: Det skulle anvendes hos voksne, der er indlagt på hospital til behandling af nyligt opstået sygdom.
English: This means that it blocks factor Xa, a protein which is involved in the production of thrombin.
Danish: Det vil sige, at det blokerer faktor Xa, der er et protein, som medvirker til dannelsen af trombin.
English: These patients may be at high risk of blood clots because of reduced mobility during their hospital treatment as well as other underlying conditions that increase the risk.
Danish: Disse patienter kan have en høj risiko for blodpropper som følge af nedsat bevægelighed under deres hospitalsindlæggelse samt andre underliggende sygdomme, der øger risikoen.
English: Blood clots that start off in the veins can move to another part of the body such as the lungs and the brain where they can cause severe problems with breathing or stroke.
Danish: Blodpropper, der opstår i venerne, kan flytte sig til andre dele af kroppen som f.eks. lungerne og hjernen, hvor de kan forårsage alvorlige vejrtrækningsproblemer eller slagtilfælde.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: Derfor var CHMP på daværende tidspunkt af den opfattelse, at fordelene ved Dexxience ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism.
Danish: Den 22. marts 2018 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse om anbefaling af afslag på ansøgningen om markedsføringstilladelse for lægemidlet Dexxience, der er beregnet til forebyggelse af venøs tromboemboli.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Dexxience.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Dexxience.
English: Also, patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine.
Danish: Desuden havde patienter, der blev behandlet med Dexxience, flere blødningsepisoder end dem, der blev behandlet med sammenligningspræparatet.
English: Treatment with Dexxience was compared with enoxaparin, another medicine for preventing blood clots.
Danish: Behandling med Dexxience blev sammenlignet med enoxaparin, et andet lægemiddel til forebyggelse af blodpropper.
English: Thrombin is needed for blood to clot.
Danish: Trombin er nødvendigt for, at blodet kan størkne.
English: By blocking factor Xa, the medicine reduces the levels of thrombin in the blood and this reduces the risk of blood clots forming in blood vessels.
Danish: Ved at blokere faktor Xa nedsætter lægemidlet blodets indhold af trombin, og derved mindskes risikoen for dannelse af blodpropper i blodårerne.
English: The CHMP considered that the main study did not satisfactorily show Dexxience's effectiveness when used for preventing blood clots in patients admitted to hospital for recent medical illness.
Danish: CHMP fandt, at hovedstudiet ikke i tilstrækkelig grad havde påvist virkningen af Dexxience, når det blev anvendt til forebyggelse af blodpropper hos patienter, der var indlagt på hospital til behandling af en nyligt opstået sygdom.
English: The patients were at high risk of venous thromboembolism because of their age, presence of a protein indicating a blood clot, previous blood clots, cancer and lack of mobility during hospital treatment.
Danish: Patienterne havde høj risiko for venøs tromboemboli på grund af alder, tilstedeværelse af et protein, der indikerer en blodprop, tidligere blodpropper, kræft og mangel på bevægelighed under hospitalsindlæggelsen.
English: This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions for whom any episode of bleeding could have serious consequences, and Dexxience's long persistence in the body could complicate management of bleeding.
Danish: Dette blev vurderet som en væsentlig betænkelighed, eftersom lægemidlet skulle anvendes hos patienter med alvorlig underliggende sygdom, for hvem en blødningsepisode kan have alvorlige konsekvenser, og da Dexxiences lange tilstedeværelse i kroppen kan komplicere behandlingen af blødningen.
English: After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 26 July 2018.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en revurdering af den oprindelige udtalelse, men fastholdt den 26. juli 2018 afslaget på ansøgningen om markedsføringstilladelse.
English: How does Dexxience work?
Danish: Hvordan virker Dexxience?
English: Dexxience was expected to be used to prevent venous thromboembolism (formation of blood clots in veins).
Danish: Dexxience skulle anvendes til forebyggelse af venøs tromboemboli (dannelse af blodpropper i venerne).
English: The main measure of effectiveness was the occurrence of deep vein thrombosis (blood clot in a deep vein, usually in the leg), or of pulmonary embolism (blood clot in the lung), or death from a blood clot.
Danish: Det primære mål for virkning var forekomsten af dyb venetrombose (blodprop i en dyb vene, typisk i benet), lungeemboli (blodprop i lungen) eller død som følge af en blodprop.
English: The active substance in Dexxience, betrixaban, is a ‘factor Xa inhibitor'.
Danish: Det aktive stof i Dexxience, betrixaban, er en faktor Xa-hæmmer.
English: EMA/501901/2018
Danish: juli 2018
English: The full EPAR and risk management plan summary for Pemetrexed Accord 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 Pemetrexed Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Accord.
English: The Committee recommended that Pemetrexed Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Pemetrexed Accord godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Pemetrexed Accord is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pemetrexed Accord anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Accord has been shown to be comparable to Alimta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Accord er sammenligneligt med Alimta.
English: Pemetrexed Accord is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed Accord er et kræftlægemiddel til behandling af to typer af lungekræft:
English: What are the benefits and risks of Pemetrexed Accord?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Accord?
English: Other information about Pemetrexed Accord
Danish: Andre oplysninger om Pemetrexed Accord
English: This means that Pemetrexed Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Danish: Det betyder, at Pemetrexed Accord svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
English: What is Pemetrexed Accord and what is it used for?
Danish: Hvad er Pemetrexed Accord, og hvad anvendes det til?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Accord, 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 Pemetrexed Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: No additional studies were needed as Pemetrexed Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Danish: Der var ikke brug for yderligere undersøgelser, da Pemetrexed Accord er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
English: It is not intended to provide practical advice on how to use Pemetrexed Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed Accord bør anvendes.
English: Because Pemetrexed Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed Accord er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
English: Pemetrexed Accord contains the active substance pemetrexed.
Danish: Pemetrexed Accord indeholder det aktive stof pemetrexed.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Accord?
English: The active substance in Pemetrexed Accord, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Danish: Det aktive stof i Pemetrexed Accord, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: For more information about treatment with Pemetrexed Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pemetrexed Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Danish: Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi Lægemidlet Pemetrexed Accord er et "generisk lægemiddel".
English: For practical information about using Pemetrexed Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Accord.
Danish: For at mindske bivirkningerne under behandlingen med Pemetrexed Accord bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12.
English: When Pemetrexed Accord is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Pemetrexed Accord gives sammen med cisplatin, bør der desuden før og efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
English: Pemetrexed Accord is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Accord fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How has Pemetrexed Accord been studied?
Danish: Hvordan er Pemetrexed Accord blevet undersøgt?
English: Why is Pemetrexed Accord approved?
Danish: Hvorfor er Pemetrexed Accord blevet godkendt?
English: How does Pemetrexed Accord work?
Danish: Hvordan virker Pemetrexed Accord?
English: How is Pemetrexed Accord used?
Danish: Hvordan anvendes Pemetrexed Accord?
English: Type (formulation)
Danish: Type (formulering)
English: Following a request from companies concerned, the PRAC re-examined its initial recommendation.
Danish: Efter en henvendelse fra en berørt virksomhed revurderede PRAC sin indledende anbefaling.
English: Commission decision date: 23/11/2017.
Danish: Dato for Kommissionens afgørelse: 23. november
English: The review of gadolinium contrast agents was initiated on 17 March 2016 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af gadoliniumholdige lægemidler blev iværksat den 17. marts 2016 på EuropaKommissionens foranledning i henhold til artikel 31 i direktiv 2001/83/EF.
English: restrict use to liver scans
Danish: begrænses til leverscanninger
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations in March 2017.
Danish: Gennemgangen blev først foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som i marts 2017 fremsatte en række anbefalinger.
English: These body scans rely on the magnetic fields produced by water molecules in the body.
Danish: Disse kropsscanninger bygger på de magnetiske felter, der dannes af vandmolekyler i kroppen.
English: The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Danish: De endelige anbefalinger er blevet fremsendt til Europa-Kommissionen, som har vedtaget en endelig, retligt bindende beslutning med gyldighed i alle EU-medlemsstater.
English: The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Danish: Det sidste trin i gennemgangsproceduren var Europa-Kommissionens vedtagelse af en retligt bindende beslutning med gyldighed i alle EU's medlemsstater.
English: • If you have any questions about your scan, speak to your doctor.
Danish: • Spørg lægen, hvis du har spørgsmål om scanningen.
English: • Healthcare professionals should always use the lowest dose that provides sufficient enhancement for diagnosis.
Danish: • Sundhedspersoner bør altid anvende den lavest mulige dosis, der giver tilstrækkelig kontrastforstærkning til diagnosticering.
English: • It is known that small amounts of gadolinium may remain in the brain after a scan with these agents, although there is currently no evidence that these small amounts cause any harm.
Danish: • Det er kendt, at små mængder gadolinium kan aflejres i hjernen efter en scanning med disse stoffer, selvom der for øjeblikket ikke er dokumentation for, at disse små mængder forårsager nogen skade.
English: OptiMARK (gadoversetamide) is the only gadolinium contrast agent that was authorised centrally via EMA in the EU.
Danish: OptiMARK (gadoversetamid) er det eneste gadoliniumholdige kontrastmiddel, der er godkendt centralt via EMA i EU.