FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 50 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET ENKELTDOSISBLISTER TIL 50 MG FILMOVERTRUKNE TABLETTER
English: Hepatic impairment
Danish: Opkastning Kvalme
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 100 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET ENKELTDOSISBLISTER TIL 100 MG FILMOVERTRUKNE TABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 50 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP KALENDERBLISTERKORT TIL 50 MG FILMOVERTRUKNE TABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 100 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP KALENDERBLISTERKORT TIL 100 MG FILMOVERTRUKNE TABLETTER
English: Verzenios 100 mg film-coated tablets abemaciclib
Danish: Verzenios 100 mg filmovertrukne tabletter abemaciclib
English: Verzenios 50 mg film-coated tablets abemaciclib
Danish: Verzenios 50 mg filmovertrukne tabletter abemaciclib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL ANVENDELSE I KALENDERBLISTERKORTET TIL 150 MG FILMOVERTRUKNE TABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL ANVENDELSE I KALENDERBLISTERKORTET TIL 50 MG FILMOVERTRUKNE TABLETTER
English: Grade 3 Toxicity
Danish: Toksicitet grad
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL ANVENDELSE I KALENDERBLISTERKORTET TIL 100 MG FILMOVERTRUKNE TABLETTER
English: When given together with an aromatase inhibitor or fulvestrant to treat your breast cancer, the recommended dose of Verzenios is 150 mg taken by mouth twice daily.
Danish: Den anbefalede dosis er 150 mg Verzenios to gange dagligt, når lægemidlet gives sammen med en aromatasehæmmer eller fulvestrant til behandling af din brystkræft.
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Danish: Tel: + 39- 055 42571
English: Hepatic metabolism is the main route of clearance for abemaciclib.
Danish: Abemaciclib metaboliseres primært via leveren.
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Danish: Tel: + 31-(0) 30 60 25 800
English: Protect from light.
Danish: Beskytte mod lys.
English: Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014
Danish: Dato for første markedsføringstilladelse: 24/07/2009 Dato for seneste fornyelse af markedsføringstilladelse: 06/06/2014
English: ATC Vet Code: QI09AA07
Danish: ATCvet-kode: QI09AA07.
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C - 8 °C).
English: Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.
Danish: På grund af nye feltstammer (PCV genotype) bør manglende forventede effekt (LEE) hændelser indsendes elektronisk årligt.
English: These clinical signs normally resolve without treatment.
Danish: Disse kliniske tegn forsvinder normalt uden behandling.
English: One injection from 21 days of age.
Danish: En injektion fra 21 dages alderen.
English: This resolves spontaneously within 48 hours without treatment.
Danish: Dette forsvinder spontant inden for 48 timer uden behandling.
English: In case of such reactions, appropriate treatment is recommended.
Danish: I tilfælde af en anafylaktisk reaktion anbefales passende behandling.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State 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 its 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 veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: The vaccine is to be administered aseptically.
Danish: Vaccinen skal administreres under aseptiske forhold.
English: SPAIN
Danish: SPANIEN
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende dette veterinære lægemiddel skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: 2000 Rockford Road, Charles City IA 50616
Danish: 2000 Rockford Road, Charles City
English: Hepes acid
Danish: Hepes syre
English: Use vaccination devices according to the manufacturer's instructions.
Danish: Vaccinationsudstyret skal avendes ifølge producentens vejledning.
English: 50 doses 125 doses
Danish: 50 doser 125 doser
English: Pigs (piglets) from 3 weeks of age.
Danish: Svin (smågrise) fra 3 ugers alderen.
English: Squalane
Danish: Squalan
English: Minimum Essential Medium without phenol red Sodium bicarbonate
Danish: Minimum Essential Medium uden phenolrødt Natriumbicarbonat
English: Vaccination schedule:
Danish: Vaccinationsprogram:
English: Interactions with other medicinal products and other forms of interaction:
Danish: Interaktion med andre lægemidler og andre former for interaktion:
English: 10 doses (20 ml)
Danish: 10 doser (20 ml)
English: The use of a multi-dosing syringe is recommended.
Danish: Det anbefales at anvende en flerdosis-sprøjte.
English: Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Danish: Lokale vævsreaktioner i form af hævelser omkring injektionsstedet er meget almindelige og kan vare i op til 26 dage.
English: Shelf life of the veterinary medicinal product as package for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år.
English: CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: a) The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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 veterinærlægemidlet 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,
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på ydre emballage og flaske.
English: A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
Danish: En midlertidig stigning i kropstemperaturen (op til 1,7 °C) er meget almindelig inden for de første 24 timer efter vaccination.
English: 0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Danish: 0,1 mg * Relativ potens bestemt ved ELISA antigen-kvantificering (in vitro potenstest) sammenlignet med en referencevaccine.
English: Exceptionally, a large proportion of animals may react in some specific herds after vaccination.
Danish: Undtagelsesvis kan en stor andel af dyr i specifikke svinebesætninger reagere efter vaccination.
English: b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
Danish: b) At den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: It is intended to stimulate active immunity against PCV2 in piglets.
Danish: Den skal stimulere aktiv immunitet mod PCV2 i smågrise.
English: The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Danish: Det hævede område er sædvanligvis under 5 cm i diameter, men i nogle tilfælde kan hævelsen være større.
English: Pigs (piglets)
Danish: Svin (smågrise)
English: Shelf life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: Anvendes straks.
English: Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting.
Danish: Pludselige milde overfølsomhedslignende reaktioner kan almindeligvis opstå efter vaccination, resulterende i forbigående kliniske tegn så som opkastning.
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder: Må ikke blandes med andre veterinærlægemidler.
English: Administer one dose of 2 ml to piglets in the neck behind the ear.
Danish: En dosis på 2 ml til smågrise indgives i nakken bag øret.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: EXP {month/year} Once broached use immediately.
Danish: EXP{måned/år} Efter anbrud anvendes straks.
English: 1348 Louvain-la-Neuve BELGIUM
Danish: 1348 Louvain-la-Neuve
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Single intramuscular injection of one dose (2 ml).
Danish: En intramuskulær injektion med en dosis (2 ml).
English: Special precautions for use in animals: Avoid stress in the animals before and after the time of vaccination.
Danish: Særlige forholdsregler til brug hos dyr: Undgå at stresse dyret før og efter vaccination.
English: Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Danish: Papæske med polyethylenflasker med en chlorobutyl elastomerlukke og aluminiumslåg.
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Danish: Fremstiller ansvarlig for batchfrigivelse: Zoetis Manufacturing & Research Spain, S.L.
English: Specific pharmacovigilance requirements:
Danish: Krav til lægemiddelovervågning:
English: The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.
Danish: Effekten hos svin med en meget høj koncentration af maternelle antistoffer, der f.eks. skyldes vaccination af moderen, er ikke påvist.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Disposal: read the package leaflet.
Danish: Bortskaffelse: Læs indlægssedlen.
English: Pregnancy and lactation: Do not use during pregnancy and lactation.
Danish: Drægtighed og laktation: Må ikke anvendes under drægtighed og laktation.
English: One dose of 2 ml contains:
Danish: En dosis på 2 ml indeholder:
English: Zero days.
Danish: 0 dage.
English: Vaccinate only healthy animals.
Danish: Kun raske dyr må vaccineres.
English: Adjuvants:
Danish: Adjuvanser:
English: Severe anaphylactic reactions are uncommon but may be lethal.
Danish: Alvorlige anafylaktiske reaktioner er ikke almindelige, men kan være dødelige.
English: In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
Danish: Kliniske undersøgelser, hvor der blev fortaget obduktioner af injektionsstedet 8 uger efter administration af en enkeltdosis vaccine, viste en mild til moderat granulomatøs inflammation af muskelfibrene ved injektionsstedet.
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr.
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til svin, inaktiverede virale vacciner
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Do not use in breeding boars.
Danish: Må ikke anvendes til avlsorner.
English: Zero days
Danish: 0 dage
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “ KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: MARKETING AUTHORISATION NUMBERS
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE
English: A milky white to pink opaque liquid, free from visible particles
Danish: En mælkehvid til pink uigennemsigtig opløsning uden synlige partikler.
English: QUANTITY OF THE ACTIVE SUBSTANCES
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER)
English: Camprodón s/n "la Riba" 17813 Vall de Bianya
Danish: 17813 Vall de Bianya
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Danish: Aktiv immunisering af svin over 3 uger mod Porcint Circovirus type 2 (PCV2) til reduktion af virusmængde i blod og lymfevæv og læsioner i lymfevæv i forbindelse med PCV2-infektion samt for at reducere kliniske symptomer - herunder tab af daglig vægtøgning og dødelighed som følge af PostWeaning Multisystemic Wasting Syndrom (PMWS).
English: Shake well before administration and intermittently during the process of vaccination.
Danish: Omryst vaccinen grundigt før indgivelse og med jævne mellemrum i løbet af vaccinationsproceduren.
English: The excipients 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 anført under 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,
English: Withdrawal period(s): Zero days.
Danish: Tilbageholdelsestid: 0 dage.
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer) Zoetis Inc.
English: Per dose of 2 ml:
Danish: En dosis på 2 ml:
English: Duration of immunity: 19 weeks post-vaccination.
Danish: Varighed af immunitet: 19 uger efter vaccination.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æsker med 10 beholdere med 10, 50 eller 125 doser Æske med 1 beholder med 10, 50 eller 125 doser
English: CLINICAL PARTICULARS 4.1 Target species
Danish: KLINISKE OPLYSNINGER 4.1 Dyrearter, som lægemidler er beregnet til
English: Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Danish: Papæske med 10 beholdere med 10 doser (20 ml), 50 doser (100 ml) eller 125 doser (250 ml).
English: Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Danish: Papæske med 1 beholder med 10 doser (20 ml), 50 doser (100 ml) eller 125 doser (250 ml).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket til beholder 50 og 125 doser
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Onset of immunity: from 3 weeks post-vaccination.
Danish: Indtræden af immunitet: fra 3 uger efter vaccination.
English: Suvaxyn PCV suspension for injection for pigs
Danish: Suvaxyn PCV injektionsvæske, suspension til svin
English: Avoid stress in the animals before and after the time of vaccination.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Undgå stress hos dyret før og efter vaccination.
English: Suspension for injection
Danish: Injektionsvæske, suspension
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs
Danish: INDLÆGSSEDDEL: Suvaxyn PCV injektionsvæske, suspension til svin
English: The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Danish: Vaccinestammen er en inaktiveret rekombinant Porcint Circovirus type 1 som udtrykker Porcint Circovirus type 2 ORF-protein.
English: 6 BATCH NUMBER
Danish: BATCHNUMMER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label 10 doses
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til beholder
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidler er beregnet til
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Danish: Efter indgivelse af dobbelt dosis vaccine er der ikke observeret andre bivirkninger, end de der er nævnt i afsnit 4.6.
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
Danish: Inaktiveret rekombinant Porcint Circovirus type 1 som Porcint Circovirus type 2 ORF-protein 1,6 ≤
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
Danish: En injektion af en dosis (2 ml) fra 21 dages alderen i nakken bag øret.
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
Danish: Inaktiveret rekombinant Porcint Circovirus type 1 som Porcint Circovirus type 2 ORF2-protein
English: Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Danish: Æske med 10 beholdere med 50 doser Æske med 10 beholdere med 125 doser
English: Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses
Danish: Æske med 1 beholder med 50 doser Æske med 1 beholder med 125 doser
English: USA
Danish: BELGIEN
English: No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Danish: Efter indgivelse af en dobbelt dosis vaccine er der ikke observeret andre bivirkninger, end de der er nævnt i afsnit 6.
English: MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelsen:
English: ANSM did not agree to the changes as requested by the company.
Danish: ANSM accepterede ikke ændringerne som anmodet af virksomheden.
English: What is Cardioxane?
Danish: Hvad er Cardioxane?
English: 1 A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
Danish: En procedure, hvorved godkendelse af et lægemiddel i én EU-medlemsstat anerkendes af en anden medlemsstat.
English: The company that markets the medicine is Clinigen Healthcare Limited.
Danish: Den virksomhed, der markedsfører lægemidlet, er Clinigen Healthcare Limited.
English: Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at en sådan sletning kan godtages.
English: It contains the active substance dexrazoxane.
Danish: Det indeholder det aktive stof dexrazoxan.
English: Why was Cardioxane reviewed?
Danish: Hvorfor blev Cardioxane vurderet igen?
English: Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France.
Danish: Cardioxane er godkendt ved en gensidig anerkendelsesprocedure1, der er baseret på den oprindelige godkendelse udstedt af Frankrig.
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Danish: Resultatet af en procedure i medfør af artikel 13 i forordning (EF) nr.
English: Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom.
Danish: Cardioxane er godkendt i Tjekkiet, Tyskland, Frankrig, Italien, Nederlandene, Polen, Spanien og Det Forenede Kongerige.