FrancophonIA/ELRC3.0 huggingface dataset:
English: In a prospective cardiovascular outcomes study (mean follow-up 5.5 years) the primary endpoint events of cardiovascular death or hospitalisation were similar between rosiglitazone and active comparators [HR 0.99 (95% CI 0.85 - 1.16)].
Danish: I en prospektiv undersøgelse af forekomsten af hjerte-kar-sygdomme (gennemsnitlig opfølgning i 5,5 år) var de primære endepunkter, død eller indlæggelse pga. hjerte-karsygdomme, lige hyppige hos de patienter, der fik rosiglitazon, og de patienter, der fik aktive komparatorer [HR 0,99 (95 % CI 0,85 - 1,16)].
English: 7, 28, 84, 90 or 112 film-coated tablets.
Danish: 7, 28, 84, 90 eller 112 filmovertrukne tabletter.
English: EU/1/00/137/010 7 tablets EU/1/00/137/011 28 tablets EU/1/00/137/015 84 tablets EU/1/00/137/018 90 tablets EU/1/00/137/012 112 tablets
Danish: EU/1/00/137/010 7 filmovertrukne tabletter EU/1/00/137/011 28 filmovertrukne tabletter EU/1/00/137/015 84 filmovertrukne tabletter EU/1/00/137/018 90 filmovertrukne tabletter EU/1/00/137/012 112 filmovertrukne tabletter
English: AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone
Danish: AVANDIA 2 mg filmovertrukne tabletter AVANDIA 4 mg filmovertrukne tabletter AVANDIA 8 mg filmovertrukne tabletter rosiglitazon
English: 56 film-coated tablets, unit dose pack
Danish: 56 filmovertrukne tabletter, enkeltdosispakning
English: Contains lactose (approximately 108 mg).
Danish: Indeholder lactose (hver tablet indeholder ca. 108 mg).
English: Iron oxide red E172.
Danish: Jernoxid rød E172.
English: in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Danish: Men alt i alt er foreliggende data om risikoen for myokardieiskæmi inkonklusive (se afsnit 4.8).
English: 4 Long-term studies show an increased incidence of bone fracture in patients, particularly female patients, taking rosiglitazone.
Danish: Langtidsundersøgelser viser en øget forekomst af frakturer hos især kvindelige patienter, der tager rosiglitazon.
English: In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)].
Danish: I en anden langtidsundersøgelse sås der øget forekomst af frakturer hos patienter i den kombinerede rosiglitazongruppe i sammenligning med den aktive kontrolgruppe [8,3 % versus 5,3 %, risikoratio 1,57 (95 % CI 1,26 - 1,97)].
English: Film coating (Opadry pink OY-L-24803): Hypromellose 6cP
Danish: Filmovertræk (Opadry lyserød OY-L-24803): Hypromellose 6cP
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common
Danish: Metabolisme og ernæring hypercholesterolæmi 1 Almindelig Almindelig hypertriglyceridæmi hyperlipidæmi vægtøgning øget appetit
English: Musculoskeletal and connective tissue disorders bone fractures4
Danish: Knogler, led, muskler og bindevæv frakturer4
English: Î Tell your doctor as soon as possible if you get any of these symptoms.
Danish: Fortæl det til lægen så hurtigt som muligt, hvis du får nogen af disse symptomer.
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets
Danish: 7 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 112 filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/137/005-009, EU/1/137/014, EU/1/137/017
English: The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets.
Danish: Tabletterne findes i blisterpakninger indeholdende 7, 28, 84, 90 og 112 filmovertrukne tabletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
English: Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandia.
Danish: Kvinder, som er infertile på grund af polycystisk ovariesyndrom, skal være opmærksomme på, at ægløsningen kan blive genetableret under behandling med Avandia.
English: Clinical trials data
Danish: Data fra kliniske forsøg
English: 7 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets 56 film-coated tablets, unit dose pack
Danish: 7 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 112 filmovertrukne tabletter 56 filmovertrukne tabletter, enkeltdosispakning
English: The frequency of adverse reactions identified from clinical trial data
Danish: Frekvens af bivirkninger identificeret under kliniske undersøgelser Bivirkning
English: Avandia 4 mg tablets are orange, marked "GSK" on one side and "4" on the other.
Danish: Avandia 4 mg tabletter er orange og præget ”GSK” på den ene side og ”4” på den anden.
English: Common Very common Very common
Danish: Meget Almindelig
English: • swelling (oedema) due to water retention.
Danish: • hævelse (ødem) på grund af væskeophobning.
English: Limited data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min) and therefore rosiglitazone should be used with caution in these patients.
Danish: Begrænsede data for patienter med alvorlig renal insufficiens (kreatinin clearance < 30 ml/min) er tilgængelige.
English: − known hypersensitivity to rosiglitazone or to any of the excipients
Danish: − overfølsomhed over for rosiglitazon eller over for et eller flere af hjælpestofferne
English: 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.
Danish: 56, 112, 168 eller 180 filmovertrukne tabletter eller 56 filmovertrukne tabletter, enkeltdosispakning.
English: The frequency of adverse reactions identified from post-marketing data
Danish: Frekvens af bivirkninger fundet efter markedsføring Bivirkning
English: INFORMATION IN BRAILLE avandia 8 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandia 8 mg
English: Read the package leaflet before use Use only as directed by your doctor
Danish: Læs indlægssedlen før brug
English: and your dose of Avandia may need to be changed.
Danish: Dit blodsukker vil blive tjekket, og din dosis af Avandia skal måske ændres.
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Danish: I forlængelse af bivirkningsdata fundet i kliniske undersøgelser er data fundet efter markedsføring af rosiglitazon listet i tabellen nedenfor.
English: Avandia 8 mg tablets are red-brown, marked "GSK" on one side and "8" on the other.
Danish: Avandia 8 mg tabletter er rødbrune og præget ”GSK” på den ene side og ”8” på den anden.
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Danish: Inden for hver organklasse er bivirkninger ved rosiglitazon i monoterapi listet med faldende frekvens.
English: In an update to this retrospective analysis that included 10 further studies that met the criteria for inclusion, but were not available at the time of the original analysis, the overall incidence of events typically associated with cardiac ischaemia was not statistically different for rosiglitazone containing regimens, 2.21% versus combined active and placebo comparators, 2.08% [HR 1.098 (95% CI 0.809 - 1.354)].
Danish: I en analyse opdateret med yderligere 10 undersøgelser, der opfyldte inklusionskriterierne, men som ikke var tilgængelige, da den oprindelige analyse blev foretaget, var der ikke statistisk forskel på forekomsten af hændelser, der typisk sættes i forbindelse med hjerteiskæmi, i behandlingsregimer med rosiglitazon (2,21 %) versus kombinerede aktive og placebo-komparatorer (2,08) [HR 1,098 (95 % CI 0,809 - 1,354)].
English: INFORMATION IN BRAILLE avandia 4 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandia 4 mg
English: INFORMATION IN BRAILLE avandia 2 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandia 2 mg
English: The tablets are provided in blister packs containing 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Danish: Tabletterne findes i blisterpakninger indeholdende 56, 112, 168 og 180 filmovertrukne tabletter eller som 56 filmovertrukne tabletter i enkeltdosis blister (unit dose).
English: Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Danish: Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Avandia til dig personligt.
English: Iron oxide red E172
Danish: Jernoxid rød E172
English: EU/1/00/137/013 168 tablets
Danish: EU/1/00/137/013 168 filmovertrukne tabletter
English: EU/1/00/137/016 180 tablets
Danish: EU/1/00/137/016 180 filmovertrukne tabletter
English: The ingredients may pass into breast milk and so may harm your baby.
Danish: Indholdsstofferne kan blive udskilt i modermælken
English: 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
Danish: 7, 28, 56, 84, 90 eller 112 filmovertrukne tabletter eller 56 filmovertrukne tabletter, enkeltdosispakning.
English: You can take Avandia with or without food.
Danish: Avandia kan tages sammen med et måltid eller på tom mave.
English: BEFORE YOU TAKE AVANDIA
Danish: Hvis du har glemt at tage Avandia
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare
Danish: Nedsat leverfunktion, primært kommet til udtryk ved forhøjede leverenzymer5
English: EU/1/00/137/003 112 tablets
Danish: EU/1/00/137/003 112 filmovertrukne tabletter
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet er receptpligtigt.
English: EU/1/00/137/002 56 tablets
Danish: EU/1/00/137/002 56 filmovertrukne tabletter
English: The tablets are provided in blister packs containing 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Danish: Tabletterne findes i blisterpakninger indeholdende 7, 28, 56, 84, 90 og 112 filmovertrukne tabletter eller som 56 filmovertrukne tabletter i enkeltdosis blister (unit dose).
English: Î Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: Common thrombocytopaenia
Danish: Almindelig Almindelig leukopeni trombocytopeni granulocytopeni
English: 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Danish: Forekomsten er højere ved 8 mg rosiglitazon sammenlignet med 4 mg rosiglitazon (som total daglig dosis).
English: Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Danish: Det kan være nødvendigt at øge overvågningen af patienten og at reducere dosis af sulfonylurinstof/insulin.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN AVANDIA 8 mg filmovertrukne tabletter.
English: • constipation
Danish: • mavesmerter
English: EU/1/00/137/004 56 tablet unit dose pack
Danish: EU/1/00/137/004 56 filmovertrukne tabletter, enkeltdosispakning
English: In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Danish: I kliniske undersøgelser med rosiglitazon har der været evidens for dosis-relateret vægtøgning.
English: Î Check with your doctor, as Avandia may not be suitable for you.
Danish: Det er ikke sikkert, at Avandia er den rigtige behandling til dig.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon.
English: Orange film-coated tablets debossed with “GSK” on one side and "4" on the other side.
Danish: Filmovertrukken tablet Orange filmovertrukne tabletter præget med "GSK" på den ene side og "4" på den anden side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 2 mg rosiglitazon.
English: Pink film-coated tablets debossed with “GSK” on one side and "2" on the other side.
Danish: Filmovertrukken tablet Lyserøde filmovertrukne tabletter præget med "GSK" på den ene side og "2" på den anden side.
English: Patients with renal impairment (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in patients with mild and moderate renal insufficiency.
Danish: Patienter med nedsat nyrefunktion (se afsnit 4.4 Væskeretention og hjerteinsufficiens):
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN AVANDIA 2 mg filmovertrukne tabletter.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN AVANDIA 4 mg filmovertrukne tabletter.
English: • heart failure
Danish: Hjerte hjerteinsufficiens2
English: Check with your doctor or pharmacist if you are not sure.
Danish: Fortæl det til din læge eller på apoteket, hvis du tager nogen af disse.
English: as monotherapy - in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with - metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Danish: Som tripel-kombinationsbehandling med - metformin og et sulfonylurinstof, til patienter (særligt overvægtige patienter) med insufficient glykæmisk kontrol trods kombinationsbehandling (se afsnit 4.4).
English: Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin.
Danish: Vægtøgningen var større, når rosiglitazon blev anvendt i kombination med insulin.
English: Myocardial Ischaemia
Danish: Lactosemonohydrat
English: Red-brown film-coated tablets debossed with “GSK” on one side and "8" on the other side.
Danish: Filmovertrukken tablet Rødbrune filmovertrukne tabletter præget med "GSK" på den ene side og "8" på den anden side.
English: Don't stop taking Avandia
Danish: Hvis du holder op med at tage Avandia
English: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Danish: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien.
English: Lactose monohydrate Glycerol triacetate
Danish: Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat
English: General disorders and administration site conditions oedema
Danish: Almene symptomer og reaktioner på administrationsstedet ødem
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
Danish: EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 8 mg tabletter rosiglitazon
English: What Avandia looks like and contents of the pack Avandia 2 mg tablets are pink and marked "GSK" on one side and "2" on the other.
Danish: Avandia 2 mg tabletter er lyserøde og præget ”GSK” på den ene side og ”2” på den anden.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 2 mg tabletter rosiglitazon
English: Eye disorders
Danish: Øjne Makulaødem
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 4 mg tabletter rosiglitazon
English: MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien.
English: • chest pain (angina)
Danish: • hævet og kløende udslæt (nældefeber)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 2 mg rosiglitazon
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 8 mg filmovertrukne tabletter rosiglitazon
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 4 mg filmovertrukne tabletter rosiglitazon
English: Film coating (Opadry pink OY-L-24802):
Danish: Filmovertræk (Opadry lyserød OY-L-24802): Hypromellose 6cP
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets rosiglitazone
Danish: LÆGEMIDLETS NAVN AVANDIA 2 mg filmovertrukne tabletter rosiglitazon
English: Triple oral therapy
Danish: Tripel-kombinationsbehandling
English: Others
Danish: Meget
English: What Avandia is and what it is used for Before you take Avandia How to take Avandia Possible side effects
Danish: Oversigt over indlægssedlen: Det skal du vide, før du begynder at tage Avandia
English: Very rare skin reactions (e.g. urticaria, pruritus, rash)
Danish: Hudreaktioner (for eksempel nældefeber, kløe, udslæt)
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Danish: GlaxoSmithKline Pharmaceuticals S.A. Tel.: + 48 (0)22 576 9000
English: Excipient
Danish: Exp
English: Common hypertriglyceridaemia Common
Danish: Almindelig Almindelig leukopeni trombocytopeni agranulocytose
English: Weight gain
Danish: − nedsat leverfunktion
English: ATCvet code QI04AA02.
Danish: ATC kode: QI04AA02.
English: Revaccination Annual.
Danish: Revaccination Årligt.
English: The periodic safety update report (PSUR) cycle should be re-started for submission of 6 monthly reports (covering all authorised presentations of this product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Danish: Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
English: The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.
Danish: Indehaveren af markedsføringstilladelsen bør anvende et passende system til kvantificering af de aktive ingredienser så hurtigt som muligt ved blandestadiet.
English: One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Danish: En injektion: fra 1-månedsalderen hos naive dyr (eller fra 2,5 måneders-alderen for dyr født af immune får).
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Anvendelse af dette veterinærlægemiddel kan kun tillades under særlige omstændigheder fastsat af det europæiske fællesskabs lovgivning om kontrol med bluetongue.
English: Shelf life of the veterinary medicinal product as package for sale: 18 months.
Danish: Opbevaringstid for det veterinære lægemiddel i salgspakning: 18 måneder.
English: The level of efficacy for other species may differ from that observed in sheep.
Danish: Effektiviteten hos andre dyrearter kan variere fra den, der er observeret hos får.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Danish: De aktive stoffer, der hovedsageligt er af biologisk oprindelse med det formål at give aktiv immunitet, er ikke omfattet af Forordning (EF) nr. 470/2009.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af det immunologiske veterinærlægemiddel på hele eller en del af sit område, hvis det godtgøres:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,