FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Once dose (2 ml) contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER En dosis (2 ml) indeholder:
English: Another key contributor to boar taint, skatole, may also be reduced as an indirect effect.
Danish: Som en indirekte virkning kan skatol, en anden nøglesubstans for ornelugt, ligeledes reduceres.
English: Shelf life after first opening: 28 days at 2-8 °C.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Opbevaringstid efter første åbning af den indre emballage: 28 dage ved 2-8 °C.
English: PACKAGE LEAFLET: Improvac, solution for injection for pigs
Danish: INDLÆGSSEDDEL: Improvac injektionsvæske, opløsning til gris
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 2 ml, by subcutaneous injection (injection given under the skin).
Danish: 2 ml, subkutan injektion (injektionen skal gives under huden).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Improvac injektionsvæske, opløsning til gris
English: The needle should be directed perpendicular to the skin surface.
Danish: Kanylen skal rettes vinkelret mod hudoverfladen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Improvac injektionsvæske, opløsning
English: Cardboard box with 4 bottles of 250 ml.
Danish: Papæske med 4 flasker på 250 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/005 - 100 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/095/005 - 100 ml
English: Once broached, the container should be returned to the refrigerator and then can be broached once more during the next 28 days, then discarded immediately after use.
Danish: Flasken kan brydes en gang til inden 28 dage, hvorefter den kasseres umiddelbart efter anvendelse.
English: DEAE-Dextran Chlorocresol Urea
Danish: DEAE-dextran
English: − very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Danish: − Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)
English: Gonadotropin releasing factor (GnRF) analogue-protein conjugate min. 300 µg.
Danish: Gonadotropin releasing factor (GnRF) analog-protein konjugat min. 300 µg.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml and 250 ml HDPE bottles
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 100 ml og 250 ml HDPE-flasker
English: PACKAGE SIZE 1 x 100 ml
Danish: PAKNINGSSTØRRELSE 1 x 100 ml
English: Cardboard box with 10 bottles of 100 ml.
Danish: Papæske med 10 flasker på 100 ml.
English: Special care should be taken to avoid accidental self-injection and needle stick injury when administering the veterinary medicinal product.
Danish: Når veterinærlægemidlet administreres, skal der udvises særlig omhu for at undgå uforsætlig selvinjektion og kanylestiksskader.
English: Cardboard box with 1 bottle of 250 ml.
Danish: Papæske med 1 flaske på 250 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 1 x 100 ml and 1 x 250 ml HDPE bottles
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æsker, 1x100 ml og 1x250 ml HDPE-flasker
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 10 x 100 ml and 4 x 250 ml HDPE bottles
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æsker, 10x100 ml og 4x250 ml HDPE-flasker
English: EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Danish: Efter anbrud: Anvendes i løbet af 28 dage.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Cardboard box with 1 bottle of 100 ml.
Danish: Papæske med 1 flaske på 100 ml.
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Danish: − Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr)
English: − common (more than 1 but less than 10 animals in 100 animals treated )
Danish: − Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/095/002 - 10 x 100 ml
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Danish: − Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
English: PACKAGE SIZE 10 x 100 ml 4 x 250 ml
Danish: PAKNINGSSTØRRELSE 10 x 100 ml
English: 6.1 List of excipient(s)
Danish: 6.1 Fortegnelse over hjælpestoffer
English: London, 24 January 2008 Doc.
Danish: London, den 24. januar 2008 Ref.dok.
English: How are these medicines expected to work?
Danish: Hvordan forventes disse lægemidler at virke?
English: This means that they were to be similar to biological medicines that are already authorised in the European Union (EU) and contain the same active substances (also known as the ‘reference medicines').
Danish: Det betyder, at de ville svare til biologiske lægemidler, der allerede er godkendt i EU, og indeholde de samme aktive stoffer (også kaldet referencelægemidlerne).
English: Ref. EMEA/4193/2008
Danish: EMEA/90169/2008
English: These three medicines are all solutions for injection that contain 100 International Units of insulin per millilitre.
Danish: Disse tre lægemidler er alle opløsninger til injektion, som indeholder 100 internationale enheder insulin pr. milliliter.
English: What were these medicines expected to be used for?
Danish: Hvad forventedes disse lægemidler anvendt til?
English: The three ‘Marvel insulins' were to contain one or both types of insulin:
Danish: De tre Marvel-insuliner skulle have indeholdt én eller begge typer insulin:
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Danish: CHMP havde formuleret en række spørgsmål, som virksomheden skulle besvare, men virksomheden havde endnu ikke indsendt sine svar.
English: These medicines would have contained insulin in two different forms: a soluble form, which acts quickly (within 30 minutes of injection), and an ‘isophane' form, which is absorbed more slowly and gives a longer duration of action.
Danish: Disse lægemidler ville have indeholdt insulin i to forskellige former: en opløst form, som virker hurtigt (inden for 30 minutter efter injektion), og en isophan form, som absorberes langsommere og giver en længere virkningsvarighed.
English: The application was at day 120 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 120, da virksomheden trak sin ansøgning tilbage.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Yderligere oplysninger om biosimilære lægemidler findes i spørgsmål og svar-dokumentet her.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis cirka to måneder om at udstede tilladelsen.
English: The CHMP was also concerned that the company had not supplied enough information on how the active substance or the finished products are made, and that the processes used to make them had not been validated.
Danish: CHMP var også betænkelig ved, at virksomheden ikke havde fremlagt tilstrækkeligt med oplysninger om, hvordan det aktive stof eller de færdige produkter fremstilles, og at de processer, der anvendes i fremstillingen, ikke var blevet valideret.
English: The medicines were expected to be used to treat patients with diabetes who need insulin to maintain their blood levels within normal levels, and to control diabetes in newly diagnosed patients and pregnant women.
Danish: Disse lægemidler forventedes anvendt til behandling af patienter med diabetes, som behøver insulin for at fastholde deres blodniveauer inden for normalområderne, og til kontrol af diabetes hos nydiagnosticerede patienter og gravide kvinder.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Danish: Diabetes er en sygdom, der gør, at kroppen ikke producerer tilstrækkeligt med insulin til at kunne kontrollere blodsukkerniveauet.
English: The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Danish: Referencelægemidlerne for disse insuliner skulle have været Humulin S, Humulin I og Humulin M3.
English: International non-proprietary name (INN): human insulin
Danish: Internationalt fællesnavn (INN): humant insulin
English: The active substance, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Danish: Det aktive stof, insulin human, produceres ved hjælp af en metode kaldet rekombinant dna-teknologi: Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere insulin.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (dag 180) til virksomheden.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der forelægges virksomheden.
English: It also presented the results of one main study in 526 patients with diabetes, who received either the Marvel insulins or the Humulin insulins for up to 12 months.
Danish: Virksomheden fremlagde også resultaterne af en hovedundersøgelse med 526 diabetespatienter, som havde fået enten Marvel-insulinerne eller Humulin-insulinerne i op til 12 måneder.
English: The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Danish: Virksomheden fremlagde data fra undersøgelser, der var udformet til at kunne vise, at Marvelinsulinerne var sammenlignelige med referencelægemidlerne i forsøgsmodeller og hos mennesker.
English: The main concerns of the CHMP were that the comparability of the Marvel insulins and the Humulin insulins had not been shown.
Danish: CHMP's vigtigste betænkeligheder bestod i, at sammenligneligheden af Marvel-insulinerne og Humulin-insulinerne ikke var blevet påvist.
English: The main measure of effectiveness was the effect of the medicines on the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: Det primære mål for virkning var lægemidlernes indvirkning på niveauerne af et stof i blodet, som kaldes glykosyleret hæmogobin (HbA1c), der giver en indikation af, hvor godt blodsukkeret kontrolleres.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Det brev, som virksomheden sendte til EMEA med underretning om tilbagetrækningen af ansøgningen, kan læses hfer.
English: They were to be available in vials or as cartridges to be used in injection pens.
Danish: De skulle have været leveret i hætteglas eller som cylinderampuller til anvendelse i injektionspenne.
English: The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin.
Danish: Undersøgelserne med raske frivillige viste ikke, at Marvel-insulinerne havde den samme sænkende virkning på blodsukkerniveauerne som Humulin-insulinerne, og hovedundersøgelsen viste en trend i Humulins favør.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes currently with the Marvel insulins.
Danish: Virksomheden har informeret CHMP om, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Marvelinsulinerne.
English: The company presented the results of studies carried out in 24 healthy volunteers looking at the effect of the Marvel insulins on blood sugar levels, compared with the Humulin insulins.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der var blevet gennemført med 24 raske frivillige, og i hvilke virkningen af Marvel-insulinerne på blodsukkerniveauer, sammenlignet med Humulin-insulinerne, var blevet undersøgt.
English: • Insulin Human 30/70 Mix Marvel: 30% soluble insulin and 70% isophane insulin.
Danish: • Insulin Human 30/70 Mix Marvel: 30 % opløst insulin og 70 % isophaninsulin.
English: On 20 December 2007, Marvel LifeSciences Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, for the treatment of diabetes mellitus.
Danish: Den 20. december 2007 meddelte Marvel LifeSciences Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel til behandling af diabetes mellitus.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
English: Therefore, at the time of the withdrawal, the CHMP's view was that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not be considered as biosimilar to the reference medicinal products Humulin S, Humulin I and Humulin M3.
Danish: Da ansøgningen blev trukket tilbage, var CHMP derfor af den opfattelse, at Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel ikke kunne anses for at være biosimilære med referencelægemidlerne Humulin S, Humulin I and Humulin M3.
English: • Insulin Human Rapid Marvel: soluble insulin,
Danish: • Insulin Human Rapid Marvel: opløst insulin
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel are replacement insulins, which contain an active substance that is identical to the insulin made by the pancreas.
Danish: Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel er erstatningsinsuliner, som indeholder et aktivt stof, der er identisk med det insulin, som produceres i bugspytkirtlen.
English: Based on the review of the data, the CHMP had some concerns and was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus.
Danish: Efter gennemgang af de foreliggende data havde CHMP sine betænkeligheder og var af den foreløbige opfattelse, at Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel ikke kunne være blevet godkendt til behandling af diabetes mellitus.
English: What are Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel?
Danish: Hvad er Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel?
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel were to be ‘biosimilar' medicines.
Danish: Insulin Human Rapid Marvel, Insulin Human Long Marvel og Insulin Human 30/70 Mix Marvel skulle have været biosimilære lægemidler.
English: • Insulin Human Long Marvel: isophane insulin,
Danish: • Insulin Human Rapid Marvel: isophaninsulin
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Insulin Human Rapid Marvel, Insulin Human Long Marvel or Insulin Human 30/70 Mix Marvel?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Insulin Human Rapid Marvel, Insulin Human Long Marvel eller Insulin Human 30/70 Mix Marvel eller i programmer for anvendelse med særlig udleveringstilladelse?
English: A procedure under Article 29(4) was therefore triggered in June 2012.
Danish: En procedure i henhold til artikel 29, stk. 4, blev derfor iværksat i juni 2012.
English: Glimepiride has been authorised in the EU since 1996.
Danish: Glimepirid har været tilladt i EU siden 1996.
English: The Applicant therefore only performed the required bioequivalence studies.
Danish: Ansøgeren udførte derfor kun de krævede bioækvivalensundersøgelser.
English: • the CHMP reviewed the available data and the justifications submitted by the Applicant,
Danish: • CHMP gennemgik de tilgængelige data og begrundelser, der var indsendt af ansøgeren
English: This implies that the composition of the different strengths will have the same impact on the in vivo absorption.
Danish: Dette medfører, at sammensætningen af de forskellige styrker vil have samme virkning på in vivo-optagelsen.
English: Overall summary of the scientific evaluation of Glimepirida Parke-Davis and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Glimepirida Parke-Davis og relaterede navne (se bilag I)
English: Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
Danish: Vedrørende partikelstørrelsen af lægemiddelstoffet anførte ansøgeren, at der anvendes en mikroniseret kornstørrelse af glimepirid, hvilket sikrer, at 95 % af partiklerne er under 10 μm, og at 50 % af partiklerne er under 4 μm.
English: Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Danish: Endelig anførte ansøgeren, at glimepirid udviser lineære farmakokinetiske egenskaber.
English: Regarding the risk for incomplete dissolution, the CHMP considered that the test and reference formulations exhibited a similar performance, indicating a similar risk for all formulations.
Danish: Vedrørende risikoen for ufuldstændig opløsning var CHMP af den opfattelse, at testen og referenceformuleringerne udviste en ensartet virkningsgrad, hvilket indikerer en lignende risiko for alle formuleringer.
English: As a result, all tablet strengths have the same average weight (170 mg) and identical qualitative and quantitative composition in terms of functional excipients, with the exception of small differences in the quantity of the filler lactose monohydrate, which is used proportionally to compensate for the differences in the active substance content (less than 5 % of the total tablet weight) resulting from the range of tablet strengths.
Danish: Som følge heraf har alle tabletstyrkerne den samme gennemsnitsvægt (170 mg) og identisk kvalitativ og kvantitativ sammensætning med hensyn til funktionelle hjælpestoffer med undtagelse af små forskelle i mængden af fyldstoffet lactosemonohydrat, som anvendes proportionelt til at kompensere for forskellene i indholdet af aktive stoffer (under 5 % af den samlede tabletvægt) som følge af de forskellige tabletstyrker.
English: The CHMP also considered the fact that the particle size of the active substance is controlled to be reassuring.
Danish: CHMP fandt det også betryggende, at partikelstørrelsen af det aktive stof kontrolleres.
English: With such a low rate of dissolution, the Applicant considered that even the 1 mg strength possesses enough sensitivity to detect formulation differences.
Danish: Med så lav en opløsning anså ansøgeren, at selv 1-mg-styrken besad tilstrækkelig følsomhed til at detektere formuleringsforskelle.
English: The CHMP was therefore of the opinion that the benefit-risk ratio of Glimepirida Parke-Davis and associated names is favourable.
Danish: CHMP var derfor af den opfattelse, at risik/benefit-forholdet for Glimepirida Parke-Davis og relaterede navne var positivt.
English: The Applicant also considered that the observed decrease in drug dissolution could be solely attributed to the inherent characteristics of glimepiride and not to formulation differences.
Danish: Ansøgeren konstaterede også, at det observerede fald i lægemiddelopløsningen alene kunne tilskrives glimepirids iboende egenskaber og ikke formuleringsforskelle.
English: The Applicant also stated that the proposed tablets are developed as look-alike formulations.
Danish: Ansøgeren oplyste desuden, at de foreslåede tabletter udvikles som ”dobbeltgængerformuleringer” (”look-alike formulations”).
English: In addition, the fraction of absorbed glimepiride is consistently described as being non dose-dependent and close to 100%, as evidenced from the rapid and complete absorption from the gastro-intestinal tract with linear increase in Cmax and AUC.
Danish: Derudover er fraktionen af absorberet glimepirid konsekvent beskrevet som værende ikke-dosisafhængig og tæt på 100 %, som godtgjort af den hurtige og fuldstændige absorption fra mave-tarmkanalen med en lineær forhøjelse af Cmax og AUC.
English: Glimepiride is a second generation sulphonylurea anti-hyperglycaemic agent used in patients with type 2 diabetes mellitus insufficiently controlled by diet and exercise alone or in combination with insulin in patients in whom diet and exercise plus oral anti-hyperglycaemic therapy have failed to control blood glucose.
Danish: Glimepirid er et antihyperglykæmisk stof indeholdende et andengenerationssulfonylurinstof til behandling af patienter med type 2-diabetes mellitus, der er utilstrækkeligt kontrolleret med diæt og motion alene eller i kombination med insulin hos patienter, hvor diæt og motion plus oral antihyperglykæmisk behandling ikke har kunnet kontrollere blodsukkeret.
English: The CHMP was therefore of the view that differences between the different strengths with regard to the in vivo rate of drug release are very unlikely.
Danish: CHMP mente derfor, at forskelle mellem de forskellige styrker med hensyn til in vivoandelen af stoffrigørelsen var meget usandsynlig.
English: In conclusion, the CHMP was of the opinion that the exceptional conditions relating to safety referred to in the Guideline on the Investigation of Bioequivalence are applicable to this particular application, despite the recommendation that bio-equivalence studies should be performed with the highest strength for substances with low solubility.
Danish: Afslutningsvis var CHMP af den opfattelse, at de usædvanlige forhold vedrørende sikkerheden, som der henvises til i retningslinjerne for undersøgelse af bioækvivalens, finder anvendelse på denne særlige anvendelse, til trods for anbefalingen om at bioækvivalensundersøgelser bør udføres med den højeste styrke for stoffer med lav opløselighed.
English: The Applicant submitted a marketing authorisation application for Glimepirida Parke-Davis, based on claims of essential similarity to the marketed reference product.
Danish: Ansøgeren indsendte en ansøgning om markedsføringstilladelse for Glimepirida ParkeDavis baseret på påberåbelse af væsentlig lighed med det markedsførte referencelægemiddel.
English: The Applicant stated that it considered the ethical concerns linked to the risk of hypoglycaemia in healthy adults when designing the bioequivalence study.
Danish: Ansøgeren anførte, at man havde taget højde for de etiske betænkeligheder forbundet med risikoen for hyperglykæmi hos sunde voksne under udformningen af bioækvivalensundersøgelsen.