FrancophonIA/ELRC3.0 huggingface dataset:
English: By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs.
Danish: Når stoffet binder sig til interleukin-5 og blokerer dets aktivitet, nedsætter Cinqaero antallet af eosinofile blodlegemer i blodet og i lungerne.
English: The infusion should be given once every four weeks, for as long as the patient is considered to benefit, and doctors should re-assess at least once a year whether treatment should be continued.
Danish: Infusionen bør gives én gang hver fjerde uge, så længe patienten findes at have gavn af den.
English: For the full list of all side effects and restrictions with Cinqaero, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cinqaero fremgår af indlægssedlen.
English: The main measure of effectiveness was based on the number of flare-ups (exacerbations) of asthma during treatment.
Danish: Det vigtigste mål for behandlingens virkning var antallet af episoder med opblussen af astmaen under behandlingen.
English: The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease.
Danish: Fordelene ved Cinqaero er påvist i to hovedundersøgelser, der omfattede 953 patienter med eosinofili astma, der ikke var velkontrolleret med inhalerede binyrebarkhormoner eller anden astmamedicin til at forebygge sygdommen.
English: It is used as an additional treatment in adults with severe asthma that is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Danish: Det anvendes som supplerende behandling til voksne med svær astma, der ikke kan kontrolleres tilstrækkeligt med en kombination af højdosis-binyrebarkhormon indtaget ved inhalation plus et andet lægemiddel, der anvendes til at forebygge astma.
English: Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma.
Danish: Lægemidlet Cinqaero udleveres kun efter recept og bør ordineres af en læge med erfaring i at behandle eosinofil astma.
English: For practical information about using Cinqaero, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cinqaero, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Danish: Det aktive stof i Cinqaero, reslizumab, er et monoklonalt antistof, der er udformet, så det bindes til stoffet interleukin-5, som stimulerer de eosinofile
English: The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma.
Danish: Den reduktion i antal episoder med opblussen af sygdommen og forbedringen i lungefunktionen, der sås med Cinqaero, blev fundet klinisk relevant, navnlig for patienter, som ikke kan kontrolleres tilstrækkeligt med høje doser af binyrebarkhormoner til inhalation sammen med et andet lægemiddel til at forebygge astma.
English: It is available as a concentrate for making a solution for infusion (drip) into a vein.
Danish: Det fås som et koncentrat til fremstilling af en opløsning, der indgives i en vene med drop (infusion).
English: Cinqaero is an asthma medicine that is used to treat adults with a particular type of asthma called eosinophilic asthma.
Danish: Cinqaero er et astmalægemiddel til at behandle voksne med en særlig form for astma, eosinofil astma.
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Danish: Symptomerne ved eosinofil astma hænger sammen med, at der er for mange hvide blodlegemer af typen eosinofil, og at der er slim i lungerne.
English: stimulates the growth and activity of eosinophils.
Danish: blodlegemers vækst og aktivitet.
English: What benefits of Cinqaero have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cinqaero?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinqaero have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cinqaero.
English: How does Cinqaero work?
Danish: Hvordan virker Cinqaero?
English: How is Cinqaero used?
Danish: Hvordan anvendes Cinqaero?
English: Additionally there was evidence of an improvement in lung function and asthma symptoms, and a decrease in number of eosinophils in the blood in patients given Cinqaero.
Danish: Hos de patienter, der fik Cinqaero, var der desuden tegn på bedring i lungefunktionen og astmasymptomerne og et fald i antallet af eosinofile blodceller.
English: An appropriate positive control was used.
Danish: Der blev anvendt en passende positiv kontrol.
English: The result of the test was negative.
Danish: Resultatet af undersøgelsen var negativt.
English: The response was submitted to the EMEA on 23 March 2006.
Danish: Besvarelsen blev forelagt EMEA den 23. marts 2006.
English: The reason for this was that the United Kingdom national competent authority, Veterinary Medicines Directorate (VMD) considered that this medicinal product could present a potential serious risk to public health on the following grounds:
Danish: Begrundelsen herfor var, at Det Forenede Kongeriges kompetente myndighed, Veterinary Medicines Directorate (VMD), fandt, at produktet kan udgøre en alvorlig risiko for den offentlige sundhed af følgende grunde:
English: Therefore it can be concluded that the effect seen in vitro is not of biological relevance.
Danish: Det kan derfor konkluderes, at den effekt, der er set in vitro, ikke er biologisk relevant.
English: The product is indicated to treat respiratory diseases in horses caused by Streptococcus equi subsp.
Danish: Produktet er indiceret til behandling af luftvejsinfektioner hos heste forårsaget af Streptococcus equi subsp.
English: Therefore, the Committee considered that no further mutagenicity study is required for the assessment of the substance.
Danish: Udvalget finder derfor ikke, at der er behov for yderligere mutagenicitetsundersøgelser for at vurdere stoffet.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Danish: I henhold til artikel 33, stk. 4 i direktiv 2001/82/EF, med senere ændringer, er sagen indbragt for CVMP.
English: zooepidemicus and severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli is involved.
Danish: zooepidemicus og svære bakterielle infektioner med høj risiko for septikæmi hos føl, hvor Escherichia coli er involveret.
English: One positive result on chromosome aberration was reported.
Danish: Der er beskrevet ét positivt resultat ved kromosomaberration.
English: Cobactan Powder and solvent for solution for injection
Danish: Cobactan Pulver og solvens til injektionsvæske, opløsning
English: The highest dose corresponded to the maximum tolerated in a dose range finding assay and also caused clear symptoms of toxicity but no lethality in all animals of the main study.
Danish: Den højeste dosis svarede til den maksimalt tolererede dosis i en dosistitreringsundersøgelse og medførte også tydelige tegn på toksicitet, men ingen letalitet hos samtlige dyr i hovedundersøgelsen.
English: Cobactan IV 4.5%, presented as a powder and solvent for solution for injection, contains 45 mg/ml cefquinome (as sulphate).
Danish: Cobactan IV 4,5 %, der dispenseres som pulver med solvens til injektionsvæske, indeholder 45 mg/ml cefquinom (som sulfat).
English: Taking into account the intrinsic values and limitations of the tests and that only one out of eleven studies has shown positive results, it is concluded that there are no concerns that 2,3-cyclohexenopyridine may present a potential serious risk to public health.
Danish: På baggrund af undersøgelsesmetodernes værdi og begrænsninger og det forhold, at kun én ud af 11 undersøgelser har givet positive resultater, konkluderes det, at der ikke er grund til at antage, at 2,3cyclohexenpyridin skulle udgøre en potentiel alvorlig risiko for folkesundheden.
English: The CVMP during its meeting of 14-16 March 2006 initiated a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Cobactan IV 4.5% containing cefquinome.
Danish: CVMP indledte på sit møde den 14.-16. marts 2006 en indbringelsesprocedure i henhold til artikel 33, stk. 4 i direktiv 2001/82/EF, med senere ændringer, for Cobactan IV 4,5 % indeholdende cefquinom.
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstillad elsen
English: The Reference Member State for the Mutual Recognition Procedure regarding Cobactan IV 4.5%, Germany, notified the EMEA on 2 March 2006 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding the product.
Danish: Tyskland, der er referencemedlemsstaten for den gensidige anerkendelsesprocedure vedrørende Cobactan IV 4,5 %, meddelte den 2. marts 2006 EMEA, at der ikke var opnået enighed om produktet i koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinærlægemidler (CMD(v)).
English: In conclusion, the CVMP agrees that it was sufficiently demonstrated that 2,3-cyclohexenopyridine has no clastogenic potential in vivo, and that further studies are not warranted.
Danish: Som konklusion er der i CVMP enighed om, at det er tilfredsstillende godtgjort, at 2,3-cyclohexenpyridin ikke har clastogent potentiale in vivo, og at der ikke er behov for yderligere undersøgelser.
English: The specifications of the active ingredient cefquinome sulphate sterile used in the manufacturing of Cobactan IV 4.5% and the specifications at release and at end of shelf-life for the powder of the finished product Cobactan IV 4.5% were provided.
Danish: Der er forelagt specifikationer for det aktive indholdsstof cefquinomsulfat, sterilt, der anvendes til fremstilling af Cobactan IV 4,5 %, samt specifikationer ved frigivelse og ved holdbarhedsperiodens udløb for pulveret i det færdige produkt Cobactan IV 4,5 %.
English: Given (1) the high proliferation rate of bone marrow tissue, (2) the intravenous route of administration, and (3) the high doses employed, it is highly unlikely that a second in vivo test in another tissue would give a positive result.
Danish: På baggrund af (1) den høje proliferationshastighed i knoglemarv, (2) den intravenøse indgivelsesvej og (3) de anvendte høje doser er det yderst usandsynligt, at endnu en in vivoundersøgelse med et andet væv vil give positivt resultat.
English: The clastogenic potential in vitro was not demonstrated in vivo.
Danish: Det clastogene potentiale in vitro er ikke blevet påvist in vivo.
English: Despite the fact that there have also been negative results in two in vivo micronucleus assays, the positive in vitro results are not negated, as both in vivo studies involved the assessment of effects in bone marrow cells.
Danish: Skønt der også har været negative resultater af to in vivo-mikronukleusundersøgelser, kan der ikke af denne grund ses bort fra de positive in vitro-resultater, da begge in vivo-undersøgelser bestod i en vurdering af virkningerne på knoglemarvsceller.
English: The CVMP concluded that the clastogenic potential in vitro was not demonstrated in vivo.
Danish: CVMP konkluderede, at det clastogene potentiale in vitro ikke er blevet påvist in vivo.
English: The positive finding in vitro was further investigated in an in vivo micronucleus test.
Danish: Det positive in vitro-resultat blev fulgt op i en in vivo-mikronukleusundersøgelse.
English: In vivo results are most relevant for human exposure, as these results “overrule” the results from in vitro tests.
Danish: In vivo-resultaterne er mest relevante for eksponering af mennesker, da de "tilsidesætter" resultaterne af in vitro-undersøgelser.
English: In the direct method, 2,3-cyclohexenopyridine induced slight structural chromosomal aberrations at 350 µg/ml with 24 and 48 h treatments.
Danish: Ved den direkte metode inducerede 2,3-cyclohexenpyridin lette strukturelle kromosomaberrationer ved behandling med 350 µg/ml i henholdsvis 24 og 48 timer.
English: As the in vivo results are most relevant for human exposure, these results “overrule” the results from the in vitro tests.
Danish: Da in vivoresultater er mest relevante for eksponering af mennesker, "tilsidesætter" de resultaterne af in vitroundersøgelser.
English: In Chinese hamster lung fibroblasts in vitro, 2,3-cyclohexenopyridine induced structural chromosomal aberrations at 600-700 µg/ml in a dose-dependent manner when including metabolic activation in the method.
Danish: I lungefibroblaster fra kinesiske hamstere inducerede 2,3-cyclohexenpyridin in vitro dosisafhængigt strukturelle kromosomaberrationer ved 600-700 µg/ml, når metabolisk aktivering medtoges i metoden.
English: The specifications at release and at end of shelf-life reports of contents of 2,3- cyclohexenopyridine of <1% and <1.5%, respectively.
Danish: Ifølge specifikationerne for det færdige produkt ved frigivelse og ved holdbarhedsperiodens udløb skal indholdet af 2,3cyclohexenpyridin være henholdsvis < 1 % og < 1,5 %.
English: In this study 2,3-cyclohexenopyridine was administered in 0.9% NaCl twice intravenously at an interval of 24 h at doses of 7.5, 25, and 75 mg/kg bw to male and female mice.
Danish: I denne undersøgelse blev 2,3-cyklohexenpyridin i 0,9 % NaCl givet to gange intravenøst med 24 timers interval til han- og hunmus i doser på 7,5, 25 og 75 mg/kg legemsvægt.
English: Genotoxicity testing was carried out at the impurity concentration of 1% with cefquinome (8 tests) and in addition 3 tests have been carried out with 2,3-cyclohexenopyridine alone.
Danish: Der er udført genotoksicitetsundersøgelser af cefquinom med et indhold af urenheden på 1 % (otte undersøgelser) foruden tre undersøgelser af 2,3-cyclohexenpyridin alene.
English: The maximum cefquinome concentrations measured in plasma of treated target animals (e.g. 2 µg/ml after a dose of 1 mg/kg bw) compared with the 2,3-cyclohexenopyridine concentrations expected (e.g. 1% of this impurity in cefquinome leading to 0.02 µg 2,3-cyclohexenopyridine/ml plasma) demonstrates that the concentrations of several hundred µg/ml in the positive in vitro test by far exceed the concentrations relevant in vivo.
Danish: De maksimale koncentrationer af cefquinom, der er målt i plasma på behandlede individer af måldyrearten (f.eks. 2 µg/ml efter en dosis på 1 mg/kg legemsvægt), sammenholdt med de forventede koncentrationer af 2,3-cyclohexenpyridin (f.eks. medfører et indhold på 1 % af denne urenhed i cefquinom en plasmakoncentration på 0,02 µg 2,3-cyclohexenpyridin/ml), viser, at koncentrationerne på flere hundrede µg/ml i den positive in vitro-undersøgelse ligger langt over de koncentrationer, der er relevante in vivo.
English: The specific findings of a clastogenic potential of 2,3- cyclohexenopyridine in one in vitro test at high concentrations was not confirmed to be present at the highest intravenous dose tested (2000 mg/kg bw) in the in vivo micronucleus test.
Danish: De specifikke resultater med hensyn til clastogent potentiale af 2,3-cyclohexenpyridin i én in vitroundersøgelse ved høje koncentrationer kunne ikke bekræftes ved den højeste afprøvede intravenøse dosis (2.000 mg/kg legemsvægt) i mikronukleusundersøgelsen in vivo.
English: 2.1 Considerations of the safety concerns regarding the starting material 2,3-cyclohexenopyridine
Danish: 2.1 Betragtninger vedrørende de sikkerhedsmæssige betænkeligheder ved udgangsmaterialet 2,3-cyclohexenpyridin
English: 2.3 Data concerning the mutagenicity and carcinogenicity of cefquinome and its starter material 2,3-cyclohexenopyridine.
Danish: 2.3 Data vedrørende mutagenicitet og carcinogenicitet af cefquinom og dets udgangsmateriale 2,3-cyclohexenpyridin
English: Specifications for cefquinome sulfate report a 2,3- cyclohexenopyridine content of <1%.
Danish: Ifølge specifikationerne for cefquinomsulfat skal indholdet af 2,3-cyclohexenpyridin være <1 %.
English: Out of the 11 genotoxicity studies available for 2,3-cyclohexenopyridine, either conducted with cefquinome containing the impurity 2,3-cyclohexenopyridine or with 2,3-cyclohexenopyridine on its own one test (chromosome aberration in vitro) resulted in a positive response and only at a high 2,3cyclohexenopyridine concentration whereas the subsequent mammalian in vivo micronucleus test resulted in a negative response.
Danish: Af de 11 genotoksicitetsundersøgelser, der foreligger for 2,3-cyclohexenpyridin, enten udført med cefquinom indeholdende urenheden 2,3-cyclohexenpyridin eller med 2,3-cyclohexenpyridin selv, har ét (in vitro-kromosomaberration) givet positiv respons, og kun ved høj koncentration af 2,3cyclohexenpyridin, hvorimod den efterfølgende in vivo-mikronukleusundersøgelse hos pattedyr var negativt.
English: 2.2 Data regarding the specification of cefquinome, in particular in relation the impurity 2,3-cyclohexenopyridine.
Danish: 2.2 Data vedrørende specifikationen af cefquinom, specielt hvad angår urenheden 2,3cyclohexenpyridin
English: Product invented name
Danish: Produktets handelsbete gnelse
English: Strength Animal species Frequency and route of administration
Danish: Lægemiddelform Styrke DyrearterDoseringshyppighed og indgivelsesvej
English: Also, the 4 in vivo genotoxicity tests performed with cefquinome at low and high concentrations of 2,3-cyclohexenopyridine were negative.
Danish: Desuden var resultaterne negative for de fire in vivo-genotokcisitetsundersøgelser, der er udført med cefquinom ved lav og høj koncentration af 2,3-cyclohexenpyridin.
English: The questions identified related to the concerns raised regarding the potential mutagenicity of 2,3cyclohexenopyridine, the starting material and impurity of cefquinome and were submitted to the Marketing Authorisation Holder on 16 March 2006.
Danish: De stillede spørgsmål vedrører de rejste betænkeligheder ved den mulige mutagenicitet af 2,3-cyclohexenpyridin, der er udgangsmateriale og optræder som urenhed i cefquinom.
English: It is considered that a negative result in a second in vivo study using a different tissue is required before the concerns about this impurity are allayed.
Danish: For at fjerne betænkelighederne ved denne urenhed anses det for nødvendigt, at endnu en in vivo-undersøgelse med et andet væv giver et negativt resultat.
English: • For the starting material 2,3 cyclohexenopyridine, which also occurs as an impurity in the active substance, cefquinome a positive in vitro mutagenicity assay has been reported.
Danish: • Der er beskrevet en positiv in vitro-mutagenicitetsundersøgelse for udgangsmaterialet 2,3cyclohexenpyridin, der også optræder som urenhed i lægemiddelstoffet cefquinom.
English: pipettes
Danish: pipetter
English: - if you have heart problems or high blood pressure
Danish: - hvis du har hjerteproblemer eller forhøjet blodtryk
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Danish: Dato for seneste fornyelse: 11. januar 2019
English: Elderly patients No dose adjustment is required in patients over 65 years.
Danish: Dosisjustering er ikke nødvendig hos patienter over 65 år.
English: LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Danish: Laventair Ellipta skal administreres på samme tidspunkt hver dag for at opretholde bronkodilatation.
English: • swelling, sometimes of the face or mouth (angioedema)
Danish: • hævelser, nogle gange i ansigtet eller i munden (angioødem)
English: - if you have severe liver problems
Danish: - hvis du har alvorlige leverproblemer.
English: Instructions for use: a) Prepare a dose
Danish: Brugervejedning: a) Klargøring af en dosis
English: Talk to your doctor before using this medicine: - if you have asthma (Don't use LAVENTAIR ELLIPTA to treat asthma)
Danish: Kontakt lægen, før du tager dette lægemiddel: - hvis du har astma (brug ikke Laventair Ellipta til behandling af astma)
English: There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Danish: Det er ikke relevant at anvende Laventair Ellipta i den pædiatriske population (i alderen under 18 år) til indikationen KOL.
English: If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Danish: Hvis du oplever nogle af de følgende symptomer, efter du har taget Laventair Ellipta, skal du stoppe med at tage denne medicin og straks kontakte din læge.
English: These include: - medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems
Danish: - medicin, som kaldes betablokkere (såsom propranolol), til behandling af forhøjet blodtryk eller andre hjerteproblemer
English: It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du tager Laventair Ellipta hver dag nøjagtigt efter lægens anvisning.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: Bivirkningernes hyppighed er defineret efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Danish: Sikkerhedsprofilen for Laventair Ellipta er baseret på sikkerhedserfaringer med umeclidinium/vilanterol og de to komponenter individuelt fra det kliniske udviklingsprogram, der omfattede 6.855 patienter med KOL, og fra spontan indrapportering.
English: EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
Danish: EU/1/14/899/001 1 inhalator med 7 doser EU/1/14/899/002 1 inhalator med 30 doser
English: Don't use LAVENTAIR ELLIPTA if you already use these medicines.
Danish: Du må ikke bruge Laventair Ellipta, hvis du allerede tager nogen af disse lægemidler.
English: Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare.
Danish: Akutte vejrtrækningsproblemer efter brug af Laventair Ellipta er sjældne.
English: The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 ”Laventair Ellipta indeholder lactose” og magnesiumstearat.
English: If you forget to use LAVENTAIR ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Laventair Ellipta Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Laventair Ellipta vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.