FrancophonIA/ELRC3.0 huggingface dataset:
English: GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines
Danish: PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer % = procentdel af børn med en titer lig med eller over “the cut-off” * = samtidig administration med DTPa-IPV vacciner ** = samtidig administration med DTPa-Hib-TT vacciner
English: Pharmaceutical form
Danish: Lægemiddelform Indgivelsesv ej
English: [See Annex I - To be completed nationally]
Danish: [Udfyldes nationalt]
English: PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Danish: % = procentdel af børn med en titer lig med eller over ”the cut-off” PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer
English: For a full list of excipients, see section 6.1.
Danish: (tetanustoksin), eller et af de øvrige indholdsstoffer (se afsnit 6).
English: Marketing authorisation under exceptional circumstances
Danish: Markedsføringstilladelse under særlige omstændigheder
English: <ANNEX IV
Danish: BILAG IV
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER SÆRLIGE OMSTÆNDIGHEDER OG <SIMILARITET> <OG> <UNDTAGELSE> <OG> <ANMODNING OM <MARKEDSFØRINGSBESKYTTELSE> <DATABESKYTTELSE> I ET ÅR> FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: [ For the status on marketing authorisation under exceptional circumstances and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]
Danish: [ For the status on marketing authorisation under exceptional circumstances and, where appropriate, for similarity and derogation, please select the statement(s) as provided below.]
English: <one-year <marketing protection> <data exclusivity>>
Danish: <<Markedsføringsbeskyttelse><Databeskyttelse> i et år>
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
Danish: <ansøgeren kan i sin ansøgning påvise, at lægemidlet, selv om det er similært med {det godkendte lægemiddel til sjældne sygdomme}, er sikrere, mere effektivt eller på anden vis klinisk overlegent (som defineret i artikel 3 i Kommissionens forordning (EC) nr. 847/2000) ved den samme terapeutiske indikation> <og>
English: <The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.>
Danish: <Efter at have vurderet ansøgningen er CHMP af den opfattelse, at risk/benefit-forholdet er positivt for anbefaling af udstedelse af markedsføringstilladelse under særlige omstændigheder.
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Danish: <CHMP er af den opfattelse, at «lægemidlets navn» er similært med allerede godkendte lægemidler til sjældne sygdomme i henhold til artikel 3 i Kommissionens forordning (EC) nr. 847/2000.
English: These reactions resolve without treatment in 2 to 5 days.
Danish: Disse bivirkninger fortager sig uden behandling i løbet af 2-5 dage.
English: A single booster injection can be given every 6 months to maintain immunity.
Danish: Der kan gives en enkelt boosterinjektion hver 6. måned for at opretholde immuniteten.
English: Protection starts at the beginning of pregnancy and lasts for 6 months.
Danish: Beskyttelsen begynder i starten af drægtighedsperioden og varer i 6 måneder.
English: If the animals come into contact with the virus the immune system will be able to respond quickly.
Danish: Hvis dyret kommer i kontakt med virusset, vil immunsystemet reagere hurtigt.
English: Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
Danish: Yderligere information om ReproCyc ParvoFLEX findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
English: The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating.
Danish: Det indledende vaccinationsforløb omfatter to indsprøjtninger med 3 ugers mellemrum, hvor den anden injektion gives mindst 3 uger før parring.
English: An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
Danish: En stigning i kropstemperaturen kan forekomme efter vaccination (hos op til 1 ud af 10 dyr), men fortager sig inden for 24-48 timer.
English: The withdrawal period for meat from pigs treated with ReproCyc ParvoFLEX is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra grise, der behandles med ReproCyc ParvoFLEX, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019.
Danish: ReproCyc ParvoFLEX fik en markedsføringstilladelse med gyldighed i hele EU den 26/04/2019.
English: The vaccine contains a porcine parvovirus protein that does not cause disease.
Danish: Vaccinen indeholder et porcint parvovirusprotein, som ikke forårsager sygdom.
English: The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site.
Danish: Den hyppigste bivirkning ved ReproCyc ParvoFLEX (som kan forekomme hos mere end 1 ud af 10 dyr) er kortvarig rødme eller hævelse (op til 4 cm) på injektionsstedet.
English: The European Medicines Agency decided that ReproCyc ParvoFLEX's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved ReproCyc ParvoFLEX opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af ReproCyc ParvoFLEX, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer.
Danish: ReproCyc ParvoFLEX indeholder også adjuvansen (indholdsstof, der styrker immunreaktionen) carbomer.
English: This will help protect the unborn piglets against porcine parvovirus infections during pregnancy.
Danish: Dette vil bidrage til at beskytte fostrene mod infektioner med porcin parvovirus under graviditeten.
English: ReproCyc ParvoFLEX is a vaccine.
Danish: ReproCyc ParvoFLEX er en vaccine.
English: A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters.
Danish: En feltundersøgelse i Spanien viste, at når ReproCyc ParvoFLEX blev givet til søer, var den lige så effektiv som en godkendt porcin parvovirusvaccine, Parvoseng, målt ved fertiliteten hos vaccinerede dyr, antallet af dødsfødsler og kuldstørrelsen.
English: When ReproCyc ParvoFLEX is given to female pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it.
Danish: Når ReproCyc ParvoFLEX gives til søer, genkender dyrenes immunsystem virusproteinet som "fremmed" og danner antistoffer mod det.
English: Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus.
Danish: Tre laboratoriestudier viste, at ReproCyc ParvoFLEX beskytter mod transplacental porcin parvovirusinfektion, eftersom mere end 95 % af pattegrisene fra vaccinerede søer var beskyttet mod infektion, og der ingen forekomst var af parvovirus.
English: Other information about ReproCyc ParvoFLEX
Danish: Andre oplysninger om ReproCyc ParvoFLEX
English: ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine)
Danish: ReproCyc ParvoFLEX (inaktiveret porcin parvovirusvaccine)
English: An overview of ReproCyc ParvoFLEX and why it is authorised in the EU
Danish: Oversigt over ReproCyc ParvoFLEX, og hvorfor det er godkendt i EU
English: ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine) EMA/153444/2019
Danish: ReproCyc ParvoFLEX (inaktiveret porcin parvovirusvaccine) EMA/245834/2019
English: Porcine parvovirus causes infertility, still births and small litters in female pigs.
Danish: Porcin parvovirus er årsag til ufrugtbarhed, dødsfødsler og små kuld hos søer.
English: ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2.
Danish: ReproCyc ParvoFLEX indeholder inaktiveret (dræbt) porcin parvovirus, stamme 27a, viralt protein 2.
English: ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta.
Danish: ReproCyc ParvoFLEX er en veterinærvaccine, der gives til søer for at beskytte deres fostre mod porcin parvovirusinfektion via placenta.
English: ReproCyc ParvoFLEX can only be obtained with a prescription and is available as an injection.
Danish: ReproCyc ParvoFLEX udleveres kun efter recept og fås som injektion.
English: What is ReproCyc ParvoFLEX and what is it used for?
Danish: Hvad er ReproCyc ParvoFLEX, og hvad anvendes det til?
English: Why is ReproCyc ParvoFLEX authorised in the EU?
Danish: Hvorfor blev ReproCyc ParvoFLEX godkendt i EU?
English: What are the risks associated with ReproCyc ParvoFLEX?
Danish: Hvilken risiko er der forbundet med ReproCyc ParvoFLEX?
English: How is ReproCyc ParvoFLEX used?
Danish: Hvordan anvendes ReproCyc ParvoFLEX?
English: It is given into the muscle of female pigs from 5 months of age.
Danish: Det gives til søer fra 5-måneders alderen som en injektion i en muskel.
English: What benefits of ReproCyc ParvoFLEX have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved ReproCyc ParvoFLEX?
English: How does ReproCyc ParvoFLEX work?
Danish: Hvordan virker ReproCyc ParvoFLEX?
English: The recommended starting dose is 1 mg per kilogram body weight per day.
Danish: Den anbefalede startdosis er 1 mg pr. kilogram kropsvægt dagligt.
English: Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Nityr findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nityr (nitisinone)
Danish: Nityr (nitisinon)
English: Nityr (nitisinone) EMA/396203/2018
Danish: Nityr (nitisinon) EMA/396203/2018
English: Other information about Nityr
Danish: Andre oplysninger om Nityr
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har desuden udført et studie, der viser, at det er "bioækvivalent" med referencelægemidlet.
English: Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient's response and body weight.
Danish: Behandlingen bør indledes hurtigst muligt, og dosis af Nityr tilpasses patientens behandlingsrespons og legemsvægt.
English: What measures are being taken to ensure the safe and effective use of Nityr?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nityr?
English: As for all medicines, data on the use of Nityr are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Nityr løbende overvåget.
English: An overview of Nityr and why it is authorised in the EU
Danish: En oversigt over Nityr, og hvorfor det er godkendt i EU
English: What is Nityr and what is it used for?
Danish: Hvad er Nityr, og hvad anvendes det til?
English: What are the benefits and risks of Nityr?
Danish: Hvilke fordele og risici er der forbundet med Nityr?
English: Because Nityr 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 Nityr er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: As for every medicine, the company provided studies on the quality of Nityr.
Danish: Som for ethvert andet lægemiddel har virksomheden fremlagt studier af kvaliteten af Nityr.
English: For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Nityr se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Nityr vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Nityr er af sammenlignelig kvalitet og er bioækvivalent med Orfadin.
English: Nityr is intended for long-term use.
Danish: Nityr er beregnet til langtidsbehandling.
English: Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Danish: Nityr udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af læger med erfaring i behandling af HT-1.
English: Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Danish: Nityr er et lægemiddel, der anvendes til behandling af arvelig tyrosinæmi type 1 (HT-1).
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet Orfadin, og de behøver ikke at blive gentaget for Nityr.
English: Why is Nityr authorised in the EU?
Danish: Hvorfor blev Nityr godkendt i EU?
English: Nityr is available as 10 mg tablets to be taken by mouth.
Danish: Nityr fås som tabletter (10 mg), der tages gennem munden.
English: Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is converted into harmful substances.
Danish: Patienter med HT-1 mangler et af disse enzymer, så tyrosin ikke nedbrydes, som det skal, i deres krop, men i stedet omdannes til skadelige stoffer.
English: However, as the unconverted tyrosine remains in the body during Nityr treatment, patients need to eat
Danish: Det uomdannede tyrosin forbliver dog i kroppen under behandlingen med Nityr, og patienterne skal derfor
English: The diet also needs to be low in phenylalanine, as this is converted to tyrosine in the body.
Danish: Diæten skal også have lavt indhold af phenylalanin, da dette omdannes til tyrosin i kroppen.
English: Nityr contains the active substance nitisinone and is a ‘generic medicine'.
Danish: Nityr indeholder det aktive stof nitisinon og er et "generisk lægemiddel".
English: The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Danish: Det aktive stof i Nityr, nitisinon, blokerer et enzym, der omdanner tyrosin til skadelige stoffer.
English: This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Orfadin.
Danish: Det betyder, at Nityr indeholder samme aktive stof og virker som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Orfadin.
English: Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Danish: Nityr anvendes i kombination med en diæt med begrænset indtagelse af aminosyrerne tyrosin og phenylalanin.
English: Therefore, the Agency's view was that, as for Orfadin, the benefit of Nityr outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Nityr opvejer de identificerede risici som for Orfadin, og at det kan godkendes til anvendelse i EU.
English: a special diet low in tyrosine.
Danish: spise en særlig diæt med lavt indhold af tyrosin.
English: How has Nityr been studied?
Danish: Hvordan blev Nityr undersøgt?
English: How is Nityr used?
Danish: Hvordan anvendes Nityr?
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and, as a result, harmful substances are formed, causing serious liver problems and liver cancer.
Danish: Derved dannes der skadelige stoffer, som hober sig op i kroppen, hvilket medfører alvorlige leverproblemer og leverkræft.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nityr have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nityr.
English: How does Nityr work?
Danish: Hvordan virker Nityr?
English: The MAH(s) should provide new randomised controlled data that will be able to robustly demonstrate that the benefits of calcitonin-containing medicines outweigh risks in patients with osteoporosis taking into account the increased risk of cancer and cancer mortality associated with long term use of calcitonin.
Danish: Analyser af randomiserede kontrollerede studier udført hos patienter med osteoarthritis og osteoporose har vist, at calcitonin er forbundet med statistisk signifikant øget risiko for cancer sammenlignet med placebobehandlede patienter.
English: Annex IV Conditions for the lifting of the suspension of the Marketing Authorisations (intranasal formulations)
Danish: Bilag III Ændringer til de relevante sektioner i produktresumé og indlægsseddel (formuleringer til injektion)
English: In order to lift the suspension of the MA, National Competent Authorities shall ensure that the following conditions are fulfilled by the MAH(s) of intranasal formulations of calcitonin-containing medicines:
Danish: Virkning og anvendelse [den nuværende godkendte ordlyd skal slettes og erstattes af følgende ordlyd] <særnavn> kan bruges ved følgende sygdomme: - Forebyggelse af knogletab hos patienter, der pludseligt er blevet immobile, fx patienter, som er sengeliggende pga. knoglebrud.
English: Conditions for the lifting of the suspension of the Marketing Authorisations (intranasal formulations)
Danish: Almindelige bivirkninger: Kræft (efter langtidsbehandling)
English: • Try to take it at about the same time each day.
Danish: • Prøv at tage det på omtrent samme tidspunkt hver dag.
English: Eating less than usual;
Danish: • Spiser mindre end normalt.
English: You may experience:
Danish: De kan opleve:
English: • In this type of epilepsy, fits first affect only one side of your brain.
Danish: • I denne type epilepsi påvirker anfaldene i begyndelsen kun den ene side af hjernen.
English: Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Danish: • Overdreven følelse af velvære, De ser og/eller hører ting, der ikke er der
English: Instead take Lacosamide Accord at the next time that you would normally take it.
Danish: I stedet skal De tage Lacosamide Accord næste gang, at De normalt ville tage den.
English: • you are often dizzy or fall over.
Danish: • De ofte bliver svimmel eller falder.
English: • you have thoughts of harming or killing yourself.
Danish: • De har tanker om at gøre skade på eller dræbe Dem selv.
English: Date of first authorisation: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 18. september 2017
English: Do not take Lacosamide Accord if any of the above applies to you.
Danish: Tag ikke Lacosamide Accord, hvis noget af ovenstående gælder for Dem.
English: Excipient(s) with known effect:
Danish: Hjælpestof(fer) med kendt virkning:
English: • medicines to treat heart problems;
Danish: • Medicin til behandling af hjerteproblemer
English: It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired.
Danish: Det anbefales derfor at indlede behandling med sirup og skifte til tabletter, hvis det ønskes.
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from available data).
Danish: Hyppigheden er defineret som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og ikke kendt (kan ikke estimeres ud fra forhåndværende data).
English: Risk related to epilepsy and antiepileptic medicinal products in general
Danish: Risiko relateret til epilepsi og antiepileptiske lægemidler generelt
English: • Lacosamide Accord may be used on its own or with other antiepileptic medicines.
Danish: • Lacosamide Accord kan bruges alene eller med andre antiepileptiske lægemidler.
English: • Do not stop taking Lacosamide Accord without talking to your doctor, as your epilepsy may come back again or become worse.
Danish: • Stop ikke med at tage Lacosamide Accord uden først at tale med Deres læge, da Deres epilepsi kan komme tilbage igen eller blive værre.
English: You should continue to take Lacosamide Accord until your doctor tells you to stop.
Danish: De skal fortsætte med at tage Lacosamide Accord, indtil lægen beder Dem om at stoppe.
English: This dose is called a maintenance dose and will depend on how you respond to Lacosamide Accord.
Danish: Denne dosis kaldes vedligeholdelsesdosis og vil afhænge af, hvordan De reagerer på Lacosamide Accord.
English: This presentation is not suitable for this category of patients.
Danish: Denne præsentation er ikke egnet til denne patientktegori.
English: • You have been given this medicine to lower the number of fits (seizures) you have.
Danish: • De har fået dette lægemiddel for at nedbringe antallet af anfald (krampeanfald) De oplever.
English: Lacosamide Accord is used as a long term treatment.
Danish: Lacosamide Accord bruges som langtidsbehandling.
English: The volume of distribution is approximately 0.6 L/kg.
Danish: Fordeling Fordelingsvolumet er ca. 0,6 l/kg.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.