FrancophonIA/ELRC3.0 huggingface dataset:
English: On 26 April 2011 the reference Member State, Ireland, referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 26. april 2011 indbragte referencemedlemsstaten Irland sagen for CVMP i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State in the Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna and the withdrawal period for meat and offal in cattle is set at 70 days.
Danish: På grundlag af de foreliggende data anså CVMP benefit/risk-forholdet for at være positivt for Prontax 10 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin, forudsat at der i produktoplysningerne tilføjes de anbefalede foranstaltninger til risikonedsættelse vedrørende risikoen over for vandorganismer og organismer i gødning og tilbageholdelsestiden for kød og slagteaffald fra kvæg fastsættes til 70 dage.
English: Therefore, CVMP adopted a positive opinion on 8 February 2012 recommending the granting of a Marketing Authorisation for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names.
Danish: Den 8. februar 2012 vedtog CVMP derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Prontax 10 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin, og relaterede navne.
English: Opinion following an Article 33(4)F F referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names EMA/281970/2012
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 4F F, for Prontax 10 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin, og relaterede navne EMA/421479/2012
English: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs (and associated names) contains doramectin.
Danish: Prontax 10 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin (og relaterede navne) indeholder doramectin.
English: referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names
Danish: 1, for Prontax 10 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin, og relaterede navne
English: EU (MA) Number
Danish: MF (EU)-nummer
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage
English: This is an acceptable number because the disease is rare.
Danish: Dette er et acceptabelt antal, da sygdommen er sjælden.
English: Cerezyme is usually given by infusion every two weeks.
Danish: Cerezyme gives sædvanligvis ved infusion hver anden uge.
English: This document is a summary of the European public assessment report (EPAR) for Cerezyme.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cerezyme.
English: The first few infusions should be given slowly, but after these, the speed of infusion can be increased under the supervision of a doctor or nurse.
Danish: De første infusioner skal gives langsomt, men derefter kan infusionshastigheden øges under opsyn af en læge eller sygeplejerske.
English: The dose and how often the infusions are given need to be adjusted according to each individual patient's symptoms and response to treatment.
Danish: Dosen og hvor ofte infusionerne gives skal tilpasses hver enkelt patients symptomer og reaktion på behandlingen.
English: The patients must have symptoms that are not affecting the nervous system, including one or more of the following conditions:
Danish: Patienterne skal have symptomer, som ikke påvirker nervesystemet, herunder en eller flere af følgende tilstande:
English: It contains the active substance imiglucerase.
Danish: Det indeholder det aktive stof imiglucerase.
English: • an enlarged liver or spleen.
Danish: • forstørret lever eller forstørret milt.
English: After training, the patient or carer can give the infusion at home, if their doctor believes it is appropriate.
Danish: Efter behørig instruktion kan patienten eller plejeren give infusionen hjemme, hvis lægen anser det for hensigtsmæssigt.
English: • thrombocytopenia (low blood platelet counts);
Danish: • trombocytopeni (lavt antal blodplader)
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cerezyme.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Cerezyme.
English: The Committee decided that Cerezyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget konkluderede, at fordelene ved Cerezyme er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cerezyme to Genzyme Europe B.V. on 17 November 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cerezyme to Genzyme Europe B.V.
English: Other information about Cerezyme:
Danish: Andre oplysninger om Cerezyme:
English: For more information about treatment with Cerezyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cerezyme, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients can develop antibodies (proteins that are produced in response to Cerezyme and can affect treatment) and they should be monitored for any allergic reactions to Cerezyme.
Danish: Patienterne kan udvikle antistoffer (proteiner, der dannes i kroppen som reaktion på Cerezyme og som kan påvirke behandlingen), og de bør overvåges for allergiske reaktioner over for Cerezyme.
English: Patients with Gaucher disease should be managed by doctors who are knowledgeable about the disease's treatment.
Danish: Patienter med Gauchers sygdom bør behandles af læger med kendskab til behandling af sygdommen.
English: The full EPAR for Cerezyme can be found here.
Danish: Den fuldstændige EPAR for Cerezyme findes her.
English: Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA), which enables it to produce the enzyme.
Danish: Det aktive stof i Cerezyme, imiglucerase, er en kopi af dette enzym, som fremstilles ved hjælp af "rekombinant DNA-teknologi": Enzymet fremstilles af en celle, som har modtaget et gen (DNA), der sætter cellen i stand til at producere enzymet.
English: For type 1 Gaucher disease, Cerezyme has been studied in three studies involving a total of 40 patients.
Danish: Behandling af Gauchers sygdom type 1 med Cerezyme er undersøgt i tre undersøgelser af i alt 40 patienter.
English: Cerezyme should not be used in people who may be hypersensitive (allergic) to imiglucerase or any of the other ingredients.
Danish: Cerezyme må ikke anvendes til personer, der kan være overfølsomme (allergiske) over for imiglucerase eller andre af indholdsstofferne.
English: Imiglucerase replaces the missing enzyme in Gaucher disease, helping to break down glucosylceramide and stopping it building up in the body.
Danish: Imiglucerase erstatter det manglende enzym i Gauchers sygdom, som hjælper med at nedbryde glucosylceramid og forhindrer det i at hobe sig op i kroppen.
English: The CHMP decided that Cerezyme gives effective control of the non-neurological symptoms of types 1 and 3 Gaucher disease.
Danish: CHMP konkluderede, at Cerezyme giver effektiv kontrol med de ikke-neurologiske symptomer på Gauchers sygdom type 1 og 3.
English: Cerezyme is used in patients who have type 1 Gaucher disease, which does not affect the nerve cells, or type 3 Gaucher disease, which progresses slowly and affects the nerve cells.
Danish: Cerezyme anvendes hos patienter med Gauchers sygdom type 1, som ikke påvirker nervecellerne eller Gauchers sygdom type 3, som er langsomt fremskridende og påvirker nervecellerne.
English: The studies have shown that Cerezyme is as safe and effective as alglucerase in controlling the symptoms of Gaucher disease.
Danish: Undersøgelserne har vist, at Cerezyme er lige så sikkert og effektivt som alglucerase til at holde symptomerne på Gauchers sygdom under kontrol.
English: The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), coughing, urticaria (hives) or angioedema (swelling beneath the skin), pruritus (itching), rash and hypersensitivity (allergic) reactions.
Danish: De hyppigste bivirkninger ved Cerezyme (der ses hos mellem 1 og 10 patienter ud af 100) er dyspnø (åndenød), hoste, urticaria (nældefeber) eller angiødem (hævelse under huden), pruritus (kløe), udslæt og allergiske reaktioner.
English: For the full list of all side effects reported with Cerezyme, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Cerezyme fremgår af indlægssedlen.
English: For type 3 Gaucher disease, which is extremely rare, the company presented data from published articles and from a special register of Gaucher disease patients.
Danish: De oplysninger, firmaet har fremlagt om Gauchers sygdom type 3, som er en yderst sjælden form af sygdommen, stammer fra publicerede artikler og fra et særligt register over patienter med Gauchers sygdom.
English: It has also been shown that patients may safely switch from alglucerase to Cerezyme treatment.
Danish: Det er desuden påvist, at det er forsvarligt at lade patienterne skifte fra behandling med alglucerase til Cerezyme.
English: Cerezyme is a powder that is made up into a solution for infusion (a drip into a vein).
Danish: Cerezyme er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: Gaucher disease has previously been treated using an enzyme called alglucerase, which was prepared from human placentas.
Danish: Til behandling af Gauchers sygdom har man tidligere anvendt et enzym kaldet alglucerase, som blev fremstillet af human moderkage.
English: Without the enzyme, glucosylceramide builds up in the body, typically in the liver, spleen and bone marrow, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Danish: Uden enzymet ophobes glucocerebrosid i kroppen, typisk i lever, milt og knoglemarv, hvilket er årsag til sygdommens symptomer: anæmi (for lavt antal røde blodlegemer), træthed, tendens til at få blå mærker, blødningstendens, forstørret milt og lever samt knoglesmerter og knoglebrud.
English: What is the risk associated with Cerezyme?
Danish: Hvilke risici er der forbundet med Cerezyme?
English: The studies compared the ability of Cerezyme and alglucerase to control the symptoms of the disease, such as increasing the number of red blood cells and platelets in the blood, and decreasing the size of the liver and spleen.
Danish: I undersøgelserne har man undersøgt, hvor effektivt Cerezyme og alglucerase er til at holde symptomerne på sygdommen under kontrol, bl.a. til at øge antallet af røde blodlegemer og blodplader samt mindske størrelsen af leveren og milten.
English: Why has Cerezyme been approved?
Danish: Hvorfor blev Cerezyme godkendt?
English: Cerezyme is used for the long-term treatment of patients with Gaucher disease.
Danish: Cerezyme anvendes til langtidsbehandling af patienter med Gauchers sygdom, som er en sjælden, arvelig sygdom.
English: What is Cerezyme?
Danish: Hvad er Cerezyme?
English: • bone disease;
Danish: • knoglesygdom
English: What is Cerezyme used for?
Danish: Hvad anvendes Cerezyme til?
English: What benefit has Cerezyme shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cerezyme?
English: How has Cerezyme been studied?
Danish: Hvordan blev Cerezyme undersøgt?
English: Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product called glucosylceramide.
Danish: Dette enzym nedbryder normalt et fedtstof kaldet glucosylceramid, som er et affaldsprodukt.
English: How is Cerezyme used?
Danish: Hvordan anvendes Cerezyme ?
English: How does Cerezyme work?
Danish: Hvordan virker Cerezyme?
English: 1 bottle
Danish: 1 flaske
English: EU/1/11/692/001 Yellox
Danish: EU/1/11/692/001
English: Ocular use bottle (PE) 5 ml
Danish: Flaske (PE) 5 ml
English: Packaging Content (concentration)
Danish: (Særnavn) Navn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: 0.9 mg/ml
Danish: Yellox mg/ml
English: Eye drops, solution
Danish: Øjendråber, opløsning Okulær anvendelse
English: Packaging
Danish: Pakning
English: Content Package size Withdrawal Period
Danish: Indhold Pakningsstørrelse
English: Strength Pharmaceutical Form
Danish: EU nummer Særnavn Styrke Lægemiddelform Dyreart Administrationsvej
English: This summary was last updated in 11-2013.
Danish: Dette sammendrag blev sidst ajourført i 11-2013.
English: It is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Danish: Det indgives sædvanligvis en eller to gange dagligt, når der er behov for en hurtig initialvirkning sammen med en langtidsvirkning.
English: The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Danish: Den sædvanlige dosis er mellem 0,3 og 1,0 international enhed (IE) pr. kg legemsvægt dagligt.
English: Mixtard is given 30 minutes before a meal.
Danish: Mixtard indtages 30 minutter før et måltid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mixtard on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mixtard den 7. oktober 2002.
English: The full EPAR for Mixtard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Mixtard 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 Mixtard.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mixtard.
English: The injection site should be changed for each injection.
Danish: Der bør anvendes et nyt injektionssted ved hver injektion.
English: Other information about Mixtard
Danish: Andre oplysninger om Mixtard
English: A risk management plan has been developed to ensure that Mixtard is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Mixtard anvendes så sikkert som muligt.
English: By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde blodsukkeret under kontrol mindskes diabetessymptomerne og -komplikationerne.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Danish: Patientens blodsukker (glukose) bør måles jævnligt for at fastsætte den effektive minimumsdosis.
English: What measures are being taken to ensure the safe and effective use of Mixtard?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mixtard?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mixtard.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Mixtard.
English: For more information about treatment with Mixtard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mixtard, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mixtard, 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 Mixtard, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet fungerer på samme måde som naturligt produceret insulin og hjælper glukosen med at trænge ind i cellerne fra blodet.
English: About onethird of the patients had type 1 diabetes and the remainder had type 2 diabetes.
Danish: Omkring en tredjedel af patienterne havde type 1-diabetes, og de øvrige havde type 2-diabetes.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Danish: HbA1c giver en indikation af, hvor godt blodsukkeret reguleres.
English: The most common side effect with Mixtard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Mixtard (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
English: This gives Mixtard a longer duration of action.
Danish: Det giver Mixtard en længerevarende virkning.
English: Mixtard was effective for both type 1 and type 2 diabetes.
Danish: Mixtard var effektivt til behandling af såvel type 1- som type 2-diabetes.
English: The active substance in Mixtard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Danish: Det aktive stof i Mixtard, human insulin, produceres via en metode, der er kendt som "rekombinant teknologi": Insulinet fremstilles af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere insulin.
English: The CHMP decided that Mixtard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Mixtard opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Mixtard.
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at regulere blodsukkeret, eller hvor kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
English: Mixtard has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Danish: Mixtard er blevet undersøgt i en undersøgelse med i alt 294 patienter, dels med type 1-diabetes, hvor bugspytkirtlen ikke kan producere insulin, dels med type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt.
English: Mixtard is used to treat diabetes.
Danish: Mixtard anvendes til behandling af diabetes (sukkersyge).
English: Mixtard contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an ‘isophane', form which is absorbed much more slowly during the day.
Danish: Mixtard indeholder insulin i to former: en opløselig form, som er hurtigvirkende (inden for 30 minutter efter injektion), og "isofan" form, som optages meget langsommere dagen igennem.
English: Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Danish: Mixtard medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau svarende til det, der var observeret for andre typer human insulin.
English: It is available as vials, cartridges (Penfill) or pre-filled pens (InnoLet or FlexPen).
Danish: Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (InnoLet eller FlexPen).
English: Mixtard is a suspension for injection that contains the active substance human insulin.
Danish: Mixtard er en injektionsvæske, suspension, som indeholder det aktive stof human insulin.
English: What is the risk associated with Mixtard?
Danish: Hvilken risiko er der forbundet med Mixtard?
English: Mixtard is given by injection under the skin, in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Danish: Mixtard gives som injektion under huden i låret, bugvæggen (maveskindet), sædemuskelregionen (ballerne) eller deltamuskelregionen (skulderen).
English: The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Danish: I undersøgelsen blev Mixtard 30 sammenlignet med en tilsvarende blanding, som er fremstillet ved hjælp af en insulin-analog (insulin aspart).
English: Why has Mixtard been approved?
Danish: Hvorfor blev Mixtard godkendt?
English: Mixtard is a replacement insulin which is very similar to the insulin made by the pancreas.
Danish: Mixtard er et erstatningsinsulin, der næsten er identisk med det insulin, som produceres af bugspytkirtlen.
English: What is Mixtard?
Danish: Hvad er Mixtard?
English: Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:
Danish: Mixtard indeholder både hurtigt virkende (opløseligt) insulin og langtidsvirkende (isofan) insulin:
English: The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: Mængden af glykosyleret hæmoglobin (HbA1c), som er den procentdel af hæmoglobin i blodet, der binder glukose til sig, blev i undersøgelsen målt efter 12 uger.
English: What benefit has Mixtard shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Mixtard?
English: How has Mixtard been studied?
Danish: Hvordan blev Mixtard undersøgt?
English: What is Mixtard used for?
Danish: Hvad anvendes Mixtard til?
English: How is Mixtard used?
Danish: Hvordan anvendes Mixtard?
English: How does Mixtard work?
Danish: Hvordan virker Mixtard?
English: is justified.
Danish: er berettiget.
English: What is tylosin?
Danish: Hvad er tylosin?
English: 10 July 2017
Danish: 10. juli 2017
English: The European Commission issued a decision on 10 July 2017.
Danish: Europa-Kommissionen traf en afgørelse den 10. juli 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/121)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/121)
English: Which data has the CVMP reviewed?
Danish: Hvilke data gennemgik CVMP?
English: On 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Danish: Finland indledte den 22. juni 2016 en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF vedrørende disse veterinærlægemidler.