FrancophonIA/ELRC3.0 huggingface dataset:
English: Nucala is provided as a lyophilised, white powder in a single-use vial for subcutaneous injection only.
Danish: Nucala leveres som et frysetørret, hvidt pulver i et engangshætteglas og er kun til subkutan injektion.
English: Dispose of the used syringe
Danish: Bortskaf den brugte sprøjte
English: The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Danish: Den anbefalede dosis af mepolizumab er 40 mg subkutant én gang hver 4. uge.
English: GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, Ireland.
Danish: GlaxoSmithKline Trading Services Ltd., Currabinny Co. Cork
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandling gives efter klinisk behov eller i henhold til den nationale giftcentrals anbefalinger (www.giftlinjen.dk).
English: Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt sprøjte Hver 1 ml fyldt sprøjte indeholder 100 mg mepolizumab.
English: The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will have 1 injection every four weeks.
Danish: Den anbefalede dosis til voksne og unge på 12 år og derover er 100 mg. Du vil få en indsprøjtning hver 4. uge.
English: Peel off the plastic cover
Danish: Fjern plastikovertrækket
English: *** The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving mepolizumab 100 mg subcutaneously.
Danish: ***De hyppigste symptomer, som var tilknyttet rapportering af systemiske, ikke-allergiske, injektionsrelaterede reaktioner, var udslæt, ansigtsrødme og myalgi.
English: Nucala 100 mg injection mepolizumab SC
Danish: Nucala 100 mg injektion mepolizumab s.c.
English: Solution for injection in pre-filled pen Multipack: 3 pre-filled pens (3 packs of 1 pre-filled pen).
Danish: Injektionsvæske, opløsning i fyldt pen Multipakning: 3 fyldte penne (3 pakninger med 1 fyldt pen).
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled pen.
Danish: Nucala fås som en 1 ml klar til opaliserende, farveløs til lysegul til lysebrun opløsning i en fyldt pen til engangsbrug.
English: • Nucala pre-filled syringe
Danish: • Nucala fyldt sprøjte
English: GlaxoSmithKline Manufacturing S.P.A. Strada Provinciale Asolana No. 90, Torrile, 43056, Parma, Italy
Danish: Strada Provinciale Asolana No. 90, Torrile, 43056, Parma, Italien eller
English: Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Danish: Børn fra 6 til 11 år Den anbefalede dosis af mepolizumab er 40 mg subkutant én gang hver 4. uge.
English: Powder for solution for injection Multipack: 3 (3 packs of 1) vials
Danish: Pulver til injektionsvæske, opløsning Multipakning: 3 (3 pakninger med 1) hætteglas
English: Take out your pre-filled syringe
Danish: Tag din fyldte sprøjte ud
English: Multipack: 3 pre-filled syringes (3 packs of 1 pre-filled syringe).
Danish: Multipakning: 3 fyldte sprøjter (3 pakninger med 1 fyldt sprøjte).
English: Nucala pre-filled syringe is for use under the skin only (subcutaneous).
Danish: Nucala fyldt sprøjte er kun til brug under huden (subkutant).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED PEN
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - FYLDT PEN
English: If necessary, the Nucala pre-filled pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30°C), when protected from light.
Danish: Nucala fyldt pen og fyldt sprøjte kan om nødvendigt tages ud af køleskabet og opbevares i den uåbnede pakning i op til 7 dage ved stuetemperatur (op til 30 °C), når beskyttet mod lys.
English: Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Danish: Voksne og unge over 12 år Den anbefalede dosis af mepolizumab er 100 mg subkutant én gang hver 4. uge.
English: Do not stop injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause your asthma symptoms and attacks to come back.
Danish: Hvis behandlingen med Nucala afbrydes midlertidigt eller stoppes helt, kan dine astmasymptomer og astmaanfald komme igen.
English: White plunge
Danish: Hvidt stempel
English: The Nucala pre-filled pen can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light.
Danish: Nucala fyldt pen kan tages ud af køleskabet og opbevares i den uåbnede karton i op til 7 dage ved stuetemperatur (op til 30 °C), beskyttet mod lys.
English: Sodium phosphate dibasic heptahydrate Polysorbate 80
Danish: Dinatriumphosphatheptahydrat Polysorbat 80
English: This magnitude of blood eosinophils reduction was maintained in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies.
Danish: Omfanget af reduktionen i antallet af eosinofile celler i blodet blev opretholdt hos patienter med svær refraktær eosinofil astma (n = 998) behandlet i gennemsnitligt 2,8 år (mellem 4 uger til 4,5 år) i åbne forlængelsesstudier.
English: The Nucala pre-filled syringe can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light.
Danish: Nucala fyldt sprøjte kan tages ud af køleskabet og opbevares i den uåbnede karton i op til 7 dage ved stuetemperatur (op til 30 °C), beskyttet mod lys.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (MULTIPACK ONLY WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (KUN MULTIPAKNINGER, UDEN BLÅ BOKS)
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet bruges med det samme, medmindre rekonstitueringen er udført under kontrollerede og validerede aseptiske forhold.
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Danish: Øvrige indholdsstoffer: saccharose, dinatriumphosphatheptahydrat, citronsyremonohydrat, polysorbat 80, EDTA-dinatriumdihydrat, vand til injektionsvæsker.
English: Powder for solution for injection 1 vial
Danish: Pulver til injektionsvæske, opløsning 1 hætteglas
English: This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
Danish: Dette vil lade stemplet komme op og kanylen
English: Solution for injection in pre-filled syringe.
Danish: Injektionsvæske, opløsning i fyldt sprøjte.
English: If your asthma symptoms get worse while receiving injections of Nucala
Danish: Hvis dine astmasymptomer forværres, mens du er i behandling med Nucala, så
English: How to store Nucala
Danish: Sådan opbevares Nucala
English: Excipients: Sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80
Danish: Hjælpestoffer: saccharose, dinatriumphosphatheptahydrat og polysorbat 80
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80.
Danish: Øvrige indholdsstoffer: saccharose, dinatriumphosphatheptahydrat og polysorbat 80.
English: Rate ratio (95% CI) p-value
Danish: Rate ratio (95 % konfidensinterval) p-værdi
English: Hypersensitivity and administration-related reactions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Package leaflet: Information for the user Nucala 100 mg powder for solution for injection mepolizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Nucala 100 mg pulver til injektionsvæske, opløsning mepolizumab Dette lægemiddel er underlagt supplerende overvågning.
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma administered mepolizumab subcutaneously every 4 weeks for 52 weeks, blood eosinophils were reduced from a geometric mean count at baseline to week 52 of 306 (n=16) to 48 (n=15) following 40 mg (for a weight < 40kg) and 331 to
Danish: Efter en dosis på henholdsvis 40 mg (for en kropsvægt < 40 kg) og 100 mg (for en kropsvægt ≥ 40 kg) subkutant hver 4. uge i 52 uger var antallet af eosinofile celler i blodet hos børn fra 6 til 11 år med svær refraktær eosinofil astma reduceret fra et geometrisk middeltal ved baseline til uge 52 på henholdsvis 306 (n=16) til 48 (n = 15) og 331 til 44 celler/mikrol (n = 10), en reduktion på henholdsvis 85 % og 87 %.
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled syringe.
Danish: Nucala fås som en 1 ml klar til opaliserende, farveløs til lysegul til lysebrun opløsning i en fyldt sprøjte til engangsbrug.
English: A total of 896 adults and 19 adolescent subjects with severe refractory eosinophilic asthma received either a subcutaneous or an intravenous dose of mepolizumab during three placebo-controlled clinical studies of 24 to 52 weeks duration.
Danish: I tre placebokontrollerede kliniske studier af 24 til 52 ugers varighed fik sammenlagt 896 voksne og 19 unge med svær refraktær eosinofil astma enten en subkutan eller en intravenøs dosis mepolizumab.
English: Reduction of exacerbation rate by baseline blood eosinophil count
Danish: Reduktion i eksacerbationsrate i forhold til baseline eosinofiltal i blodet.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger
English: Exacerbation rate per year Percent reduction Rate ratio (95% CI) p-value
Danish: Eksacerbationsrate pr. år Reduktion i procent Rate ratio (95 % konfidensinterval) p-værdi
English: Safely, throw the pen away if it has been kept out of the refrigerator for more than 7 days.
Danish: Sikkerhed; kassér medicinen, hvis den har været uden for køleskabet i mere end 7 dage.
English: Nucala is available in a pack containing 1 vial, or in multipacks with 3 individual vials.
Danish: Nucala fås i pakninger med 1 hætteglas eller i multipakninger med 3 enkelte hætteglas.
English: After reconstitution, each ml of solution contains 100 mg mepolizumab.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske 100 mg mepolizumab.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - FYLDT SPRØJTE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FYLDT SPRØJTE
English: Exacerbations rate per year Percent reduction Rate ratio (95% CI) p-value
Danish: Eksacerbationsrate pr. år Reduktion i procent Rate ratio (95 %
English: Nucala 100 mg powder for solution for injection
Danish: Nucala 100 mg pulver til injektionsvæske, opløsning
English: Multipack comprising 3 (3 packs of 1) pre-filled pens
Danish: Multipakning med 3 (3 pakninger á 1) fyldte penne.
English: Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled pen mepolizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Nucala 100 mg injektionsvæske, opløsning i fyldt pen mepolizumab Dette lægemiddel er underlagt supplerende overvågning.
English: Baseline (SD)
Danish: Baseline (SD) Middelændring i forhold til baseline (SE)
English: Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled syringe mepolizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Nucala 100 mg injektionsvæske, opløsning i fyldt sprøjte mepolizumab Dette lægemiddel er underlagt supplerende overvågning.
English: If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be used.
Danish: Hvis der er partikler i injektionsvæsken, eller hvis injektionsvæsken er uklar eller mælkeagtig, må injektionsvæsken ikke bruges.
English: Do not remove the needle cap at this stage.
Danish: Du må ikke fjerne kanylehætten endnu.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED SYRINGE MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INTERMEDIÆRE EMBALLAGE INTERMEDIÆR KARTON - FYLDT SPRØJTE MULTIPAKNING (UDEN BLÅ BOKS)
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED PEN MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INTERMEDIÆRE EMBALLAGE INTERMEDIÆR KARTON - FYLDT PEN MULTIPAKNING (UDEN BLÅ BOKS)
English: Local injection site reactions
Danish: Lokale reaktioner på administrationsstedet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (INDIVIDUAL PACKS INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (ENKELTPAKNINGER, MED BLÅ BOKS)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL FOR PRE-FILLED PEN MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET TIL FYLDT PEN MULTIPAKNING (MED BLÅ BOKS)
English: Solution for injection (injection) A clear to opalescent, colourless to pale yellow to pale brown solution
Danish: Injektionsvæske, opløsning (injektion) En klar til opaliserende, farveløs til lysegul til lysebrun opløsning.
English: 1 ml solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt sprøjte 1 ml opløsning i type 1 glassprøjte med fastmonteret kanyle (rustfrit stål) og passiv kanylebeskyttelse.
English: • fever (high temperature)
Danish: • feber
English: • If necessary, the pre-filled pen may be kept at room temperature, up to 30°C, for no more than
Danish: • Den fyldte pen kan om nødvendigt opbevares i op til 7 dage ved stuetemperatur, op til 30 °C, når den opbevares i den originale karton.
English: Nucala 100 mg powder for solution for injection mepolizumab
Danish: Nucala 100 mg pulver til injektionsvæske, opløsning mepolizumab
English: Multipack comprising 3 (3 packs of 1) pre-filled syringe
Danish: Multipakning med 3 (3 pakninger á 1) fyldte sprøjter.
English: Each 1 mL pre-filled pen contains 100 mg of mepolizumab.
Danish: Hver 1 ml fyldt pen indeholder 100 mg mepolizumab.
English: The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Danish: Sikkerhedsprofilen for mepolizumab hos patienter med svær refraktær eosinofil astma (n = 998) behandlet i gennemsnitligt 2,8 år (mellem 4 uger til 4,5 år) i åbne forlængelsesstudier svarede til den, der blev observeret i de placebokontrollerede studier.
English: Discard if left out of the refrigerator for more than 7 days.
Danish: Kassér medicinen, hvis den har været uden for køleskabet i mere end 7 dage.
English: Excipients
Danish: Rygsmerter
English: • If necessary, the pre-filled syringe may be kept at room temperature, up to 30°C, for no more than
Danish: • Den fyldte sprøjte kan om nødvendigt opbevares i op til 7 dage ved stuetemperatur, op til 30 °C, når den opbevares i den originale karton.
English: The immunogenicity profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Danish: Immunogenicitetsprofilen for mepolizumab hos patienter med svær refraktær eosinofil astma (n = 998) behandlet i gennemsnitligt 2,8 år (interval: 4 uger til 4,5 år) i åbne forlængelsesstudier svarede til den, der blev observeret i de placebokontrollerede studier.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - FOR PRE-FILLED SYRINGE MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET - FYLDT SPRØJTE MULTIPAKNING (MED BLÅ BOKS)
English: Know your pre-filled syringe
Danish: Kend din fyldte sprøjte
English: Each 1 ml pre-filled syringe contains 100 mg mepolizumab.
Danish: Hver 1 ml fyldt sprøjte indeholder 100 mg mepolizumab.
English: 1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt pen 1 ml opløsning i type 1 glassprøjte med fastmonteret kanyle (rustfrit stål) i en fyldt pen.
English: Automatic needle guard
Danish: Automatisk kanylebeskyttels e
English: The liquid should be clear to opalescent, colourless to pale yellow to pale brown.
Danish: Væsken skal være klar til opaliserende, farveløs til lysegul til lysebrun.
English: Mean Change From Baseline (SE) Difference (mepolizumab vs. placebo) 95% CI p-value
Danish: Forskel (mepolizumab vs. placebo)
English: 1 pre-filled syringe
Danish: 1 fyldt sprøjte
English: If you use more Nucala than you should
Danish: Hvis du har brugt for meget Nucala
English: Multipack comprising 3 (3 packs of 1) vials
Danish: Multipakning med 3 (3 pakninger med 1) hætteglas.
English: Remove the needle cap
Danish: Fjern kanylehætten
English: 1 pre-filled syringe.
Danish: 1 fyldt sprøjte.
English: Stopping treatment with Nucala
Danish: Sådan bliver du behandlet med Nucala
English: Each vial contains 100 mg of mepolizumab.
Danish: Hvert hætteglas indeholder 100 mg mepolizumab.
English: Nucala 100 mg solution for injection in pre-filled pen mepolizumab
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt pen mepolizumab
English: Nucala 100 mg solution for injection in pre-filled syringe mepolizumab
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt sprøjte mepolizumab
English: Eczema
Danish: Dosering
English: Nucala 100 mg solution for injection in pre-filled pen
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt pen.
English: Pull off the needle cap
Danish: Træk kanylehætten af
English: If you are breast-feeding, you must check with your doctor before you use Nucala.
Danish: Hvis du ammer, må du ikke få Nucala, medmindre du har aftalt det med lægen.
English: Breast-feeding
Danish: Mepolizumab
English: Nucala 100 mg solution for injection in pre-filled syringe
Danish: Nucala 100 mg injektionsvæske, opløsning i fyldt sprøjte.
English: {text}
Danish: {tekst}
English: Timetable for the implementation of this position
Danish: Tidsplan for implementering af denne indstilling
English: Adoption of CMDh position: {Month Year} CMDh meeting
Danish: Vedtagelse af CMDh's indstilling: CMDh-møde {måned år}
English: <Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)>
Danish: <Ændringer, der skal indføres i de relevante punkter i produktresumeet (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning)>
English: Annex <III> <IV>
Danish: Bilag <III> <IV>
English: Amendments to the product information of the nationally authorised medicinal product(s)
Danish: Ændringer i produktinformationen for det/de nationalt godkendte lægemiddel/lægemidler
English: To the extent that additional medicinal products containing {active substance(s) as EURD list entry} are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
Danish: I det omfang andre lægemidler indeholdende {det/de aktive stof(fer) i henhold til EURD-listen} allerede er godkendt eller søges godkendt i EU, anbefaler CMDh, at de relevante medlemsstater og ansøger/indehaver af markedsføringstilladelsen/-tilladelserne tager behørigt hensyn til CMDh's indstilling.
English: Transmission to National Competent Authorities of the translations of the annexes to the position: {DD/MM/YYYY}
Danish: Oversættelser af bilagene for indstillingen fremsendes til de relevante nationale myndigheder: {DD/MM/ÅÅÅÅ}
English: On the basis of the scientific conclusions for {active substance(s) as EURD list entry} the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing {active substance(s) as EURD list entry} is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for {det/de aktive stof(fer) i henhold til EURD-listen} er CMDh af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder {det/de aktive stof(fer) i henhold til EURD-listen}, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne omfattet af denne PSUR-vurdering bør ændres.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {active substance(s) as EURD list entry}, the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for {navn på det/de aktive stof(fer)} er CMDh nået frem til følgende videnskabelige konklusioner:
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): {DD/MM/YYYY}
Danish: Indstillingen implementeres i medlemsstaterne (indehaveren af markedsføringstilladelsen indsender variationsansøgning): {DD/MM/ÅÅÅÅ}
English: Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: <Annex III>
Danish: <Bilag III>
English: <Conditions to the Marketing Authorisation(s)>
Danish: <Betingelser for markedsføringstilladelsen/-tilladelserne>
English: <Summary of Product Characteristics>
Danish: <Produktresumé>
English: <Package Leaflet>
Danish: <Indlægsseddel>
English: Powder and solvent for solution for injection
Danish: Særnavn Styrke Lægemiddelform Administration Emballage
English: Route of administration
Danish: EMA's procedurenr.
English: Date of first authorisation: 15/05/2017.
Danish: Dato for første markedsføringstilladelse: 15/05/2017.
English: However, a clear antipyretic effect has been demonstrated in the first 48 hours after administration.
Danish: Imidlertid er der påvist en klar antipyretisk effekt i de første 48 timer efter administration.
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE
Danish: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANKRIG
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Danish: Officiel, national og regional antibiotikapolitik bør følges, når veterinærlægemidlet anvendes.
English: These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.
Danish: Disse reaktioner var forbigående og forsvandt normalt uden yderligere behandling i løbet af 5-15 dage, men i visse tilfælde varede de op til 49 dage.
English: Meat and offal: 56 days.
Danish: Slagtning: 56 dage.
English: Bovine 200
Danish: Kvæg 200
English: Therefore, the veterinary medicinal product should not be administered by pregnant women.
Danish: Derfor bør det veterinære lægemiddel ikke administreres af gravide kvinder.
English: The single dose volume should not exceed 15 ml per injection site.
Danish: Injektionsvolumen bør ikke overstige 15 ml pr. injektionssted.