FrancophonIA/ELRC3.0 huggingface dataset:
English: Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.
Danish: Eurican Herpes 205 er beregnet til at beskytte hvalpene mod denne infektion i de første få levedage.
English: Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.
Danish: Eurican Herpes 205 anvendes til immunisering af drægtige tæver til forebyggelse af dødsfald, kliniske symptomer og skader hos hvalpe forårsaget af infektioner med hundeherpesvirus inden for de første levedage.
English: Other information about Eurican Herpes 205:
Danish: Andre oplysninger om Eurican Herpes 205:
English: The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus.
Danish: Den anden undersøgelse havde til formål at vise, hvilken beskyttelse hvalpene får fra tæver vaccineret mod hundeherpesvirus.
English: Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection.
Danish: Eurican Herpes 205 er et pulver og solvens (opløsningsvæske), der anvendes til at fremstilling af en injektionsvæske, emulsion.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Eurican Herpes 205 opvejer eventuelle risici ved immunisering af raske katte mod hundeherpesvirus.
English: The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals.
Danish: Injektion af Eurican Herpes 205 kan medføre forbigående hævelse på indstiksstedet hos op til 10 % af dyrene.
English: Eurican Herpes 205 showed good protection from canine herpes virus.
Danish: Eurican Herpes 205 gav god beskyttelse mod hundeherpesvirus.
English: When injected, this small exposure helps the dog's immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies.
Danish: Når hunden udsættes for denne lille dosis antigener, vil dens immunsystem producere antistoffer mod hundeherpesviruset for at udrydde det.
English: Why has Eurican Herpes 205 been approved?
Danish: Hvorfor blev Eurican Herpes 205 godkendt?
English: They recommended that Eurican Herpes 205 should be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Eurican Herpes 205.
English: Eurican Herpes 205 contains small amounts of canine herpes virus antigens.
Danish: Eurican Herpes 205 indeholder små mængder antigener fra hundeherpesvirus.
English: How has the effectiveness of Eurican Herpes 205 been studied?
Danish: Hvordan blev virkningen af Eurican Herpes 205 undersøgt?
English: What is Eurican Herpes 205?
Danish: Hvad er Eurican Herpes 205?
English: What are the side effects of Eurican Herpes 205?
Danish: Hvilke bivirkninger har Eurican Herpes 205?
English: What is Eurican Herpes 205 used for?
Danish: Hvad anvendes Eurican Herpes 205 til?
English: How does Eurican Herpes 205 work?
Danish: Hvordan virker Eurican Herpes 205?
English: What benefit has Eurican Herpes 205 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Eurican Herpes 205?
English: 09 October 2013
Danish: Den 09. oktober 2013
English: Committee for Human Medicinal Products.
Danish: Udvalget for Lægemidler til Mennesker.
English: The European Commission issued a decision on this opinion on 09 October 2013.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 09. oktober 2013.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, hvis de frembringer samme mængde af det aktive stof i kroppen.
English: The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
Danish: Udvalget bemærkede desuden, at undersøgelserne var udført af ansøgeren før offentliggørelsen af den nye, opdaterede vejledning1 for produkter af denne type.
English: The company wanted the authorisation to be recognised in Belgium, France, Germany, Luxembourg, Malta, Netherlands, Sweden and United Kingdom (the ‘concerned Member States').
Danish: Frankrig, Tyskland, Luxembourg, Malta, Nederlandene, Sverige og Det Forenede Kongerige ("de berørte medlemsstater").
English: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party.
Danish: Spørgsmål og svar: Udtalelser om specifikke spørgsmål stillet til arbejdsgruppen vedrørende farmakokinetik.
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den danske sundhedsstyrelse indbragte sagen til CHMP med henblik på voldgift den 21. december 2012.
English: Sandoz A/S submitted Methylphenidate Sandoz for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Cyprus, Finland, Poland, Portugal and Spain, as well as Iceland and Norway.
Danish: Sandoz A/S ansøgte om godkendelse af Methylphenidate Sandoz ved den gensidige anerkendelsesprocedure på grundlag af den oprindelige godkendelse, der blev udstedt af Danmark den 29. marts 2012, og som desuden er gyldig ved en decentral procedure i Cypern, Finland, Polen, Portugal og Spanien samt i Island og Norge.
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Sandoz.
Danish: Den 25. juli 2013 gennemførte Det Europæiske Lægemiddelagentur (EMA) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Methylphenidate Sandoz.
English: It is available as a modified-release tablet, which releases some of the active substance immediately (the ‘immediate-release phase') and the rest over several hours.
Danish: Det leveres som en tablet med modificeret udløsning, der udløser en del af det aktive stof med det samme ("den hurtige udløsningsfase") og resten i løbet af nogle timer.
English: What is Methylphenidate Sandoz?
Danish: Hvad er Methylphenidate Sandoz?
English: Methylphenidate belongs to a group of medicines called ‘psychostimulants' and is thought to work by enhancing the activity of areas of the brain that control attention and concentration.
Danish: Methylphenidat tilhører en gruppe lægemidler, der kaldes "psykostimulantia", og menes at virke ved at øge aktiviteten i de områder i hjernen, der styrer opmærksomhed og koncentration.
English: Requirements for demonstration of bioequivalence for generics of biphasic modified release formulations for oral use.
Danish: Krav til påvisning af bioækvivalens for generiske lægemidler med bifasisk modificeret udløsning til oral anvendelse.
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Danish: Det har været på markedet siden 1950'erne både som tabletter og kapsler med hurtig udløsning, hvor methylphenidat udløses med det samme, samt som tabletter med modificeret udløsning, der udløser alt det aktive stof eller en del heraf langsommere over nogle timer.
English: Methylphenidate Sandoz is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Danish: Methylphenidate Sandoz er et generisk lægemiddel, der er baseret på et "referencelægemiddel" ved navn Concerta, som i forvejen er godkendt i alle EU's medlemsstater.
English: Methylphenidate is a medicine that is used to treat children aged between 6 and 18 years of age who have ADHD (attention deficit/hyperactivity disorder), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Danish: Methylphenidat er et lægemiddel, der anvendes til behandling af børn mellem seks og 18 år med ADHD (hyperaktiv opmærksomhedsforstyrrelse), dvs. en tilstand, hvor barnet vedholdende er ude af stand til at koncentrere sig, er hyperaktivt og udviser impulsiv adfærd.
English: Why was Methylphenidate Sandoz reviewed?
Danish: Hvorfor blev Methylphenidate Sandoz vurderet igen?
English: As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation.
Danish: Da det i produktinformationen er anført, at tabletten kan tages sammen med et måltid eller mellem måltiderne, var det nødvendigt med en bioækvivalensundersøgelse under ikke-fastende betingelser, for at der kan udstedes markedsføringstilladelse.
English: The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Sandoz was bioequivalent for the immediate-release phase to its reference product.
Danish: Begrundelsen for indbringelsen var indvendinger rejst af Tyskland og Nederlandene, som fandt, at bioækvivalensundersøgelsen, der var udført under ikke-fastende betingelser, ikke viste, at Methylphenidate Sandoz var bioækvivalent med referenceproduktet hvad angår den hurtige udløsningsfase.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Danish: CHMP tog stilling på grundlag af vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget og konkluderede, at den manglende påvisning af bioækvivalensen mellem Methylphenidate Sandoz og referencelægemidlet i den hurtige udløsningsfase og under ikke-fastende betingelser skyldtes forskelle mellem patienterne med hensyn til de virkninger, som et fedtrigt måltid har på kroppens håndtering af lægemidlerne, og ikke forskelle mellem formuleringerne af de to lægemidler, samt at der er påvist bioækvivalens med referencelægemidlet.
English: The CHMP therefore concluded that the benefits of Methylphenidate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Methylphenidate Sandoz opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Sandoz outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Methylphenidate Sandoz opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Danmark, kan anerkendes i andre EU-medlemsstater.
English: This overview was last updated in 09-2019.
Danish: Denne oversigt blev sidst ajourført i 09-2019.
English: It is available as tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).
Danish: Det findes som tabletter (500 og 1.000 mg) og som oral opløsning (100 mg/ml).
English: The total dose for the whole day should be less than 100 mg per kilogram body weight.
Danish: Den samlede daglige dosis bør være mindre end 100 mg pr. kg kropsvægt.
English: The doctor may interrupt treatment if iron levels get too low.
Danish: Lægen kan afbryde behandlingen, hvis jernniveauet bliver for lavt.
English: Patients with thalassaemia major need frequent blood transfusions.
Danish: Patienter med thalassæmi major har behov for hyppige blodtransfusioner.
English: Further information on Ferriprox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
Danish: Yderligere information om Ferriprox findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
English: • on its own, when standard iron chelator treatment cannot be used or does not work well enough;
Danish: • alene, når en jernchelaterende standardbehandling ikke kan anvendes eller ikke fungerer godt nok
English: Ferriprox received a marketing authorisation valid throughout the EU on 25 August 1999.
Danish: Ferriprox fik en markedsføringstilladelse med gyldighed i hele EU den 25. august 1999.
English: Deferoxamine was given by injection under the skin overnight.
Danish: Deferoxamin blev indgivet ved injektion under huden for natten.
English: Over time, the excess iron can damage important organs such as the heart and liver.
Danish: Med tiden kan overskud af jern beskadige vitale organer såsom hjerte og lever.
English: • in combination with another iron chelator, when treatment with one iron chelator on its own does not work or when iron levels need to be rapidly or intensively corrected to prevent or treat lifethreatening conditions (mainly affecting the heart).
Danish: • i kombination med et andet jernchelat, når behandling med ét jernchelat ikke fungerer, eller når jernniveauerne hurtigt eller intensivt skal korrigeres for at forebygge eller behandle livstruende sygdomme (som primært påvirker hjertet).
English: Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Danish: Mindre hyppige men mere alvorlige bivirkninger er agranulocytose (meget lave mængder af granulocytter, en form for hvide blodlegemer) og neutropeni (lave mængder af neutrofiler, en form for hvide blodlegemer, der bekæmper infektioner).
English: It attaches to iron in the body to form a compound that can be removed from the body, mainly in the urine, and to a lesser extent in the stools.
Danish: Det binder sig til jernet i kroppen og danner en forbindelse, som kan fjernes fra kroppen, hovedsageligt gennem urinen og i mindre grad i afføringen.
English: As for all medicines, data on the use of Ferriprox are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ferriprox løbende overvåget.
English: This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
Danish: Det er en arvelig sygdom, hvor patienterne ikke er i stand til at danne tilstrækkeligt hæmoglobin, som er det protein i de røde blodlegemer, der transporterer ilt rundt i kroppen.
English: Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.
Danish: Patienter bør straks underrette deres læge, hvis de har symptomer, der kan skyldes en infektion, såsom feber, ondt i halsen og influenzalignende symptomer.
English: The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests.
Danish: Lægen kan justere dosen af Ferriprox alt efter, hvor godt patientens jernindhold reguleres, hvilket bør måles hver 2.-3. måned med blodprøver.
English: The blood ferritin level indicates how much iron is being stored in the body.
Danish: Ferritin-niveauet viser, hvor meget jern der er lagret i kroppen.
English: There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.
Danish: Der var for få patienter i studiet til at bevise, om en sådan behandling er lige så effektiv som deferoxamin taget alene.
English: Transfused red cells bring iron into the body.
Danish: De overførte røde blodlegemer bringer jern ind i kroppen.
English: What measures are being taken to ensure the safe and effective use of Ferriprox?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ferriprox?
English: Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ferriprox vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency decided that Ferriprox'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 Ferriprox opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The average blood ferritin levels were similar in the two treatment groups.
Danish: De gennemsnitlige ferritin-niveauer i de to behandlingsgrupper var lig hinanden.
English: Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia.
Danish: Ferriprox fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i at behandle thalassæmi.
English: Removing iron in this way helps to correct the iron overload and prevent damage from excess iron.
Danish: Udskillelse af jern på denne måde bidrager til at afhjælpe jernophobningen og forebygge skader på grund af overskud af jern.
English: Other information about Ferriprox
Danish: Andre oplysninger om Ferriprox
English: The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Danish: Virksomheden, der markedsfører Ferriprox, skal sørge for, at patienter eller deres omsorgspersoner får udleveret et påmindelseskort med information om vigtigheden af regelmæssige kontroller af neutrofiltal, af at holde øje med symptomer på infektion og af at undgå at blive gravid under behandling med Ferriprox.
English: When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Danish: Når patienten tager Ferriprox, bør vedkommendes neutrofiltal kontrolleres regelmæssigt (hver uge i det første år og derefter sjældnere).
English: If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often.
Danish: Hvis patienten får en infektion, bør behandlingen med Ferriprox ophøre midlertidigt, og neutrofiltallet kontrolles oftere.
English: The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Danish: Den anbefalede dosis af Ferriprox er 25 mg pr. kg legemsvægt én gang ugentligt.
English: Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
Danish: Ferriprox blev undersøgt hos 247 patienter over 6 år med thalassæmi major.
English: An overview of Ferriprox and why it is authorised in the EU
Danish: En oversigt over Ferriprox, og hvorfor det er godkendt i EU
English: The main measure of effectiveness was the change in the levels of ferritin in the blood.
Danish: Virkningen blev hovedsageligt bedømt på ændringen af ferritin-niveauet i blodet.
English: The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Danish: De hyppigste bivirkninger ved Ferriprox (som kan forekomme hos mere end 1 ud af 10 personer) er rødbrun urin (der viser, at der bliver udskilt jern), kvalme, mavesmerter og opkastninger.
English: Ferriprox contains the active substance deferiprone.
Danish: Ferriprox indeholder det aktive stof deferipron.
English: Why is Ferriprox authorised in the EU?
Danish: Hvorfor er Ferriprox godkendt i EU?
English: For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ferriprox, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: With repeated transfusions, the iron builds up because the body does not have a natural way of removing excess iron.
Danish: Med gentagne transfusioner ophobes jern, fordi kroppen ikke kan fjerne overskydende jern ad naturlig vej.
English: Ferriprox (deferiprone)
Danish: Ferriprox (deferipron)
English: Ferriprox is used:
Danish: Ferriprox anvendes:
English: What is Ferriprox and what is it used for?
Danish: Hvad er Ferriprox, og hvad anvendes det til?
English: In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
Danish: I et andet studie med deltagelse af 60 patienter, der blev behandlet over 12 måneder, blev en kombination af Ferriprox og deferoxamin (Ferriprox i 5 dage plus deferoxamin i 2 dage hver uge) sammenlignet med deferoxamin alene.
English: For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger ved Ferriprox fremgår af indlægssedlen.
English: Ferriprox must not be used in women who are pregnant or breastfeeding.
Danish: Ferriprox må ikke anvendes af kvinder, der er gravide eller ammer.
English: However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Danish: Den gennemsnitlige koncentration af jern i leveren hos Ferriprox-behandlede patienter syntes dog at stige mere end hos patienter behandlet med deferoxamin.
English: The active substance in Ferriprox, deferiprone, is an iron chelator.
Danish: Det aktive stof i Ferriprox, deferipron, er et "jernchelat".
English: Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis.
Danish: Ferriprox må heller ikke anvendes sammen med lægemidler, der kan forårsage neutropeni eller agranulocytose.
English: In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
Danish: I et offentliggjort studie førte Ferriprox sammen med deferoxamin også til større fald i jern i hjertet sammenlignet med patienter, der tager deferoxamin alene.
English: The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
Danish: I hovedstudiet, der omfattede 71 patienter, blev Ferriprox sammenlignet med deferoxamin, et andet jernchelat, over 2 år.
English: Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Danish: Ferritin-niveauet i blodet blev reduceret i samme grad hos patienter, der fik kombinationsbehandlingen, som hos patienter, der fik deferoxamin alene.
English: What are the risks associated with Ferriprox?
Danish: Hvilke risici er der forbundet med Ferriprox?
English: Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Danish: Ferriprox må ikke anvendes hos personer, der har haft neutropeni eller agranulocytose.