FrancophonIA/ELRC3.0 huggingface dataset:
English: • If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib.
Danish: • Dacomitinib skal seponeres midlertidigt, hvis udslæt, erytematøse eller eksfoliative hudsygdomme af grad 2 vedvarer i mere end 72 timer, på trods af behandling.
English: The median duration of any grade and Grade ≥ 3 ILD/pneumonitis was 13 weeks and 1.5 weeks, respectively (see section 4.4).
Danish: Den mediane varighed af ILS/pneumonitis af enhver grad og grad ≥3 var henholdsvis 13 uger og 1,5 uger (se pkt.
English: PPIs should be avoided while receiving treatment with dacomitinib (see section 4.4).
Danish: PPI'er skal undgås under behandlingen med dacomitinib (se pkt.
English: Tél: +33 (0)1 58 07 34 40
Danish: Tel: +33 (0)1 58 07 34 40
English: • Weakness
Danish: • Svækkelse
English: There was no effect on reproductive organs in male rats given ≤ 2 mg/kg/day for 6 months (approximately 1.1 times the unbound AUC at the recommended human dose), or in dogs given ≤ 1 mg/kg/day for 9 months (approximately 0.3 times the unbound AUC at the recommended human dose).
Danish: ved den anbefalede humane dosis) eller hos hunde, der fik ≤1 mg/kg/dag i 9 måneder (ca. 0,3 gange det ubundne AUC ved den anbefalede humane dosis).
English: g Pruritus includes the following PTs: Pruritus, Rash pruritic.
Danish: Pruritus omfatter følgende foretrukne termer: Pruritus, kløende udslæt.
English: Woman of childbearing potential/Contraception
Danish: Fertile kvinder/prævention
English: The median time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to the worst episode of exfoliative skin conditions was 6 weeks.
Danish: Mediantiden til den første episode med eksfoliative hudsygdomme af enhver grad var 6 uger, og mediantiden til den alvorligste episode med eksfoliative hudsygdomme var 6 uger.
English: The median duration of any grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4).
Danish: Den mediane varighed af diarré af enhver grad og diarré af grad ≥3 var henholdsvis 20 uger og 1 uge (se pkt.
English: How to take Vizimpro
Danish: Sådan skal du tage Vizimpro
English: Dacomitinib was clastogenic in the in vitro human lymphocyte chromosome aberration assay at cytotoxic concentrations.
Danish: Ved cytotoksiske koncentrationer var dacomitinib klastogent i en in vitro human lymfocyt kromosomafvigelsesanalyse.
English: Following oral administration of a single 45-mg dose of [
Danish: Efter oral administration af en enkelt dosis [
English: Dacomitinib is a substrate for the membrane transport proteins P-gp and BCRP.
Danish: Mad ændrer ikke biotilgængeligheden i nogen klinisk relevant grad. Dacomitinib er et substrat for membrantransportproteinerne P-gp og BCRP.
English: Upon recovery to Grade ≤ 1, resume dacomitinib with a reduction of 1 dose level.
Danish: Når der indtræder bedring til grad ≤ 1, kan dacomitinib genoptages med en dosisreduktion svarende til 1 niveau.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Vizimpro Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Upon recovery to Grade ≤ 1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level.
Danish: Ved bedring til grad ≤ 1, skal dacomitinib genoptages på samme dosisniveau, eller en dosisreduktion svarende til 1 niveau skal overvejes.
English: e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis.
Danish: Stomatitis omfatter følgende foretrukne termer: Aftøs ulcus, cheilitis, mundtørhed, mucosal inflammation, mundsår, mundsmerter, orofaryngeale smerter, stomatitis.
English: The stratification factors were Race (Japanese vs mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation in exon 21) at randomisation per IWRS.
Danish: Stratificeringsfaktorerne var: race (japanere vs. kinesere fra fastlandet og andre østasiatere vs. ikke-østasiatere) og EGFR-mutationsstatus (deletion i exon 19 vs. L858R-mutationen i exon 21) ved randomisering ifølge IWRS.
English: The median time to the first episode of any grade of transaminases increased was approximately 12 weeks and the median time to the worst episode of transaminases increased was 12 weeks in patients receiving dacomitinib.
Danish: Mediantiden til den første episode med forhøjede transaminaser af enhver grad var ca. 12 uger, og mediantiden til den alvorligste episode med forhøjede transaminaser var 12 uger hos patienter, der fik dacomitinib.
English: The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time to the worst episode of ILD/pneumonitis was 16 weeks in patients receiving dacomitinib.
Danish: Mediantiden til den første episode med ILS/pneumonitis af enhver grad var 16 uger, og mediantiden til den alvorligste episode med ILS/pneumonitis var 16 uger hos patienter, der fik dacomitinib.
English: The active substance is dacomitinib (as dacomitinib monohydrate).
Danish: Vizimpro indeholder: - Aktivt stof: dacomitinib (som dacomitinibmonohydrat).
English: Stomatitis e
Danish: Vægttab a
English: The median duration of any grade and Grade ≥ 3 exfoliative skin conditions was 10 weeks and approximately 2 weeks, respectively.
Danish: Den mediane varighed af eksfoliative hudsygdomme af enhver grad og eksfoliative hudsygdomme af grad ≥3 var henholdsvis 10 uger og ca. 2 uger.
English: Palmar-plantar erythrodysaesthesia syndrome Skin fissures Dry skin f
Danish: Palmoplantar erytrodysæstesisyndrom Hudfissurer
English: Upon recovery, resume dacomitinib with a reduction of 1 dose level.
Danish: Når der indtræder bedring, kan dacomitinib genoptages med en dosisreduktion svarende til 1 niveau.
English: Vizimpro 15 mg tablet: each tablet contains 15 mg dacomitinib Vizimpro 30 mg tablet: each tablet contains 30 mg dacomitinib Vizimpro 45 mg tablet: each tablet contains 45 mg dacomitinib
Danish: Vizimpro 15 mg: hver tablet indeholder 15 mg dacomitinib Vizimpro 30 mg: hver tablet indeholder 30 mg dacomitinib Vizimpro 45 mg: hver tablet indeholder 45 mg dacomitinib - Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglykolat, magnesiumstearat (se pkt.
English: Impairment of fertility
Danish: Fertilitetsnedsættelse
English: If you become pregnant while taking this medicine, you should immediately talk to your doctor.
Danish: Du skal omgående fortælle det til lægen, hvis du bliver gravid, mens du tager dette lægemiddel.
English: The median time to the first episode of any grade rash and erythematous skin conditions was approximately 2 weeks and the median time to the worst episode of rash and erythematous skin conditions was 7 weeks in patients receiving dacomitinib.
Danish: Mediantiden til den første episode med udslæt og erytematøse hudsygdomme af enhver grad var ca. 2 uger, og mediantiden til den alvorligste episode med udslæt og erytematøse hudsygdomme var 7 uger hos patienter, der fik dacomitinib.
English: Duration of Response in Responders (per IRC) Number of responders per IRC review, n
Danish: Antal patienter der responderer ifølge IRCgennemgang, n (%)
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets dacomitinib
Danish: Vizimpro 15 mg filmovertrukne tabletter Vizimpro 30 mg filmovertrukne tabletter Vizimpro 45 mg filmovertrukne tabletter dacomitinib
English: Initiate treatment or provide additional treatment (e.g., oral antibiotics and topical steroids).
Danish: Start behandling eller giv yderligere behandling (fx oral antibiotika og topikale steroider).
English: The median time to the first episode of any grade diarrhoea was 1 week and the median time to the worst episode of diarrhoea was 2 weeks in patients receiving dacomitinib.
Danish: Mediantiden til den første episode med diarré af enhver grad var 1 uge, og mediantiden til den alvorligste episode med diarré var 2 uger hos patienter, der fik dacomitinib.
English: In humans, dacomitinib undergoes oxidation and glutathione conjugation as the major metabolic pathways.
Danish: Oxidering og glucuronidering er de primære metaboliseringsveje for dacometinib hos mennesker.
English: Initiate treatment (e.g., oral antibiotics and topical steroids).
Danish: Påbegynd behandling (fx oral antibiotika og topikale steroider).
English: Interstitial lung disease*c
Danish: Interstitiel lungesygdom*
English: Skin and subcutaneous tissue disorders Rash e
Danish: Hud og subkutane væv
English: C] dacomitinib, the most abundant circulating metabolite was O-desmethyl dacomitinib.
Danish: C]-mærket dacomitinib på 45 mg var O-desmethyldacomitinib den væsentligste cirkulerende metabolit.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Dispose unused medicinal product in accordance with local requirements.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: The median duration of any grade and Grade ≥ 3 rash and erythematous skin conditions was 53 weeks and 2 weeks, respectively.
Danish: For udslæt og erytematøse hudsygdomme var den mediane varighed af enhver grad og af grad ≥3 henholdsvis 53 uger og 2 uger.
English: Initiate treatment (e.g., antibiotics, topical steroids, and emollients).
Danish: Påbegynd behandling (fx antibiotika, topikale steroider og blødgørende midler).
English: In particular, the hazard ratios (HRs) for PFS per IRC review in Asian and non-Asian patients were 0.509 (95% CI: 0.391, 0.
Danish: Subgruppe analyserne af PFS ifølge gennemgangen af IRC baseret på baselinekarakteristika var overensstemmende med resultaterne fra den primære analyse af PFS. Specielt var hazard-ratioer for PFS hos asiatiske og ikke-asiatiske patienter ifølge gennemgangen af IRC henholdsvis 0,509 (95% CI: 0,391 0-662) og 0,889 (95% CI: 0,568-1,391).
English: h Nail disorder includes the following PTs: Ingrowing nail, Nail bed bleeding, Nail bed inflammation, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Danish: h Neglesygdom omfatter følgende foretrukne termer: Nedgroede negle, blødende neglerod, neglerodsinflammation, misfarvning af neglene, neglesygdom, negleinfektion, negletoksicitet, onykoklase, onykolyse, onykomadese, paronychia.
English: Do not stop taking Vizimpro unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Vizimpro, medmindre din læge fortæller dig det. Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib.
Danish: • Stil dacomitinib-behandling i bero ved udslæt, erytematøse eller eksfoliative hudsygdomme af grad ≥ 3.
English: INFORMATION IN BRAILLE Vizimpro 30 mg
Danish: Vizimpro 30 mg
English: Vizimpro 45 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Danish: - Vizimpro 45 mg filmovertrukne tabletter leveres som blå, runde, bikonvekse filmovertrukne tabletter, der er præget med “Pfizer” på den ene side og “DCB45” på den anden side.
English: The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Danish: Lav (sur) pH medfører højere opløselighed.
English: What Vizimpro looks like and contents of the pack Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, debossed with “Pfizer” on one side and “DCB15” on the other.
Danish: Udseende og pakningsstørrelser - Vizimpro 15 mg filmovertrukne tabletter leveres som blå, runde, bikonvekse filmovertrukne tabletter, der er præget med “Pfizer” på den ene side og “DCB15” på den anden side.
English: Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Danish: - Vizimpro 30 mg filmovertrukne tabletter leveres som blå, runde, bikonvekse filmovertrukne tabletter, der er præget med “Pfizer” på den ene side og “DCB30” på den anden side.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter.
English: INFORMATION IN BRAILLE Vizimpro 45 mg
Danish: Vizimpro 45 mg
English: • Tiredness
Danish: • Hudtørhed
English: Vizimpro 45 mg film-coated tablets
Danish: Vizimpro 45 mg filmovertrukne tabletter
English: Each film-coated tablet contains 121 mg of lactose monohydrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 121 mg lactosemonohydrat.
English: INFORMATION IN BRAILLE Vizimpro 15 mg
Danish: Vizimpro 15 mg
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Danish: Beskyt dig mod solen ved hjælp af beskyttende tøj og solcreme.
English: Each film-coated tablet contains 81 mg of lactose monohydrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 81 mg lactosemonohydrat.
English: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Danish: Blå, rund, bikonveks filmovertrukket tablet på 9,0 mm, præget med “Pfizer” på den ene side og “DCB45” på den anden side.
English: Dose modification and management for Vizimpro adverse reactions Adverse reactions
Danish: Dosisjustering og behandling ved bivirkninger i forbindelse med Vizimpro
English: • For Grade 2 rash, erythematous or exfoliative skin conditions, no dose modification is required.
Danish: • Dosisjustering er ikke nødvendig i forbindelse med udslæt af grad 2, erytematøse eller eksfoliative hudsygdomme.
English: Vizimpro 30 mg film-coated tablets
Danish: Vizimpro 30 mg filmovertrukne tabletter
English: EXPIRY DATE EXP
Danish: EXP
English: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Danish: Blå, rund, bikonveks filmovertrukket tablet på 7,5 mm, præget med “Pfizer” på den ene side og “DCB30” på den anden side.
English: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Danish: Blå, rund, bikonveks filmovertrukket tablet på 6,35 mm, præget med “Pfizer” på den ene side og “DCB15” på den anden side.
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Grade 3 rash and erythematous skin condition adverse reactions were the most frequently reported Grade 3 adverse reactions (25.5%).
Danish: De hyppigst rapporterede bivirkninger af grad 3 (25,5%) var udslæt og erytematøse hudsygdomme.
English: Vizimpro 15 mg film-coated tablets
Danish: Vizimpro 15 mg filmovertrukne tabletter
English: Polyvinyl alcohol - partially hydrolysed (E1203)
Danish: Opadry II Blue 85F30716 indeholdende: Polyvinylalkohol - delvist hydrolyseret (E1203) Talcum (E553b)
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg tablets dacomitinib
Danish: Vizimpro 30 mg tabletter dacomitinib
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg tablets dacomitinib
Danish: Vizimpro 45 mg tabletter dacomitinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate).
Danish: Hver filmovertrukket tablet indeholder 45 mg dacomitinib (som dacomitinibmonohydrat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate).
Danish: Hver filmovertrukket tablet indeholder 30 mg dacomitinib (som dacomitinibmonohydrat).
English: • For Grade ≥ 3 diarrhoea, withhold dacomitinib.
Danish: • Dacomitinib skal seponeres midlertidigt ved diarré af grad ≥ 3.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg tablets dacomitinib
Danish: Vizimpro 15 mg tabletter dacomitinib
English: • For Grade 1 exfoliative skin conditions, no dose modification is required.
Danish: • Dosisjustering er ikke nødvendig i forbindelse med eksfoliative hudsygdomme af grad 1.
English: • For Grade 1 rash or erythematous skin conditions, no dose modification is required.
Danish: • Dosisjustering er ikke nødvendig i forbindelse med udslæt eller erythematøse hudsygdomme af grad 1.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate).
Danish: Hver filmovertrukket tablet indeholder 15 mg dacomitinib (som dacomitinibmonohydrat).
English: Hepatic impairment
Danish: Træthed Asteni
English: Transaminases increased j
Danish: Forhøjede transaminaser Vægttab
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg film-coated tablets dacomitinib
Danish: Vizimpro 30 mg filmovertrukne tabletter dacomitinib
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg film-coated tablets dacomitinib
Danish: Vizimpro 45 mg filmovertrukne tabletter dacomitinib
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Danish: 30 filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg film-coated tablets dacomitinib
Danish: Vizimpro 15 mg filmovertrukne tabletter dacomitinib
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 40 mg lactosemonohydrat.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib.
Danish: Vizimpro 45 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder dacomitinibmonohydrat svarende til 45 mg dacomitinib.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Danish: Vizimpro 30 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder dacomitinibmonohydrat svarende til 30 mg dacomitinib.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Danish: Vizimpro 15 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder dacomitinibmonohydrat svarende til 15 mg dacomitinib.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Oversigt over indlægssedlen
English: 662) and 0.889 (95% CI: 0.568, 1.391), respectively.
Danish: Stratificeret HR-0,589 (95 % CI: 0,469; 0,739) Stratificeret log-rank p-værdi (2-sidet)<0,0001 Stratificeret log-rank p-værdi (1-sidet)<0,0001
English: Dry skin includes the following PTs: Dry skin, Xerosis.
Danish: Hudtørhed omfatter følgende foretrukne termer: hudtørhed, xerose.
English: i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Danish: Neglesygdom omfatter følgende foretrukne termer: Nedgroede negle, misfarvning af neglene, neglesygdom, negleinfektion, negletoksicitet, onykoklase, onykolyse, onykomadese, paronychia Forhøjede transaminaser omfatter følgende foretrukne termer: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser.
English: Patients with a history of ILD have not been studied.
Danish: Der findes ingen studier af patienter med ILS i anamnesen.
English: • Weight loss
Danish: Nedsat leverfunktion
English: BATCH NUMBER Lot
Danish: BATCHNUMMER
English: 0.83 ml (75 mg/0.83 ml)
Danish: Fyldt sprøjte (glas) 0,83 ml (75 mg/0,83 ml)
English: MA EU Number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn
English: 2 pre-filled syringes + 2 alcohol pads
Danish: 2 fyldte sprøjter + 2 alkoholservietter
English: 75 mg Solution for injection
Danish: 75 mg injektionsvæske, opløsning
English: Immediate Packaging
Danish: Subkutan anvendelse
English: These measures should help to protect the environment.
Danish: Disse foranstaltninger skal bidrage til at beskytte miljøet
English: ATCvet code: QI05AI01.
Danish: ATCvet kode: QI05AI01.
English: that may require symptomatic treatment.
Danish: Dette kan kræve symptomatisk behandling.
English: • Do not use after the expiry date stated on the label.
Danish: • Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
English: 10x1 ml (10 doses).
Danish: 10x1 ml (10 doser).
English: One dose of 1 ml contains:
Danish: 1 dosis på 1 ml indeholder:
English: Date of first authorisation: 6/03/2003 Date of last renewal: 6/03/2013
Danish: Dato for første markedsføringstilladelse: 06/03/2003 Dato for seneste fornyelse af markedsføringstilladelse: 06/03/2013
English: After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Danish: Efter inokulering multipliceres virus ikke hos hest men afgiver beskyttende proteiner.
English: Type I glass vial.
Danish: Type I hætteglas.
English: • A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Danish: • En let temperaturforøgelse (max. 1,5 °C) kan forekomme i 1 dag, undtagelsesvis i 2 dage.
English: • A transient swelling which usually regresses within 4 days may appear at the injection site.
Danish: • Forbigående hævelse, der sædvanligvis forsvinder i løbet af 4 dage, kan forekomme på injektionsstedet.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu
English: The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Danish: Da de aktive stoffer primært er af biologisk oprindelse med henblik på at give aktiv immunitet, er de ikke omfattet af Forordning (EU) 470/2009.
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP.
Danish: * vCP indhold kontrolleret ved global FAID50 (fluorescent assay infektiøs dosis 50 %) og qPCR rate mellem vCP.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Danish: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frankrig
English: The periodic safety update report (PSUR) cycle would be re-started for submission of 6 monthly reports (covering all authorised presentations of the 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 excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 if the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: Hjælpestoffer samt adjuvans, som angivet i produktresuméet punkt 6.1, er enten tilladte stoffer, der er inkluderet i tabel 1 i bilaget til Kommissionens forordning (EU) No 37/2010, der indikerer, at ingen MRL-værdier er påkrævet, eller disse stoffer anses ikke for at være omfattet af Forordning (EF) nr. 470/2009 når de anvendes som i dette lægemiddel.
English: Active substances:
Danish: Aktive substanser: