FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean age of patients was 66 years (59.9% aged 65 and over, 19.7% aged 75 and over), 63% of patients were men, and all were Caucasian.
Danish: Patienternes gennemsnitsalder var 66 år (59,9 % i alderen 65 og derover, 19,7 % i alderen 75 og derover), 63 % af patienterne var mænd, og alle var kaukasere.
English: In healthy adult subjects, patiromer caused a dose dependent increase in faecal potassium excretion, and a corresponding decrease in urinary potassium excretion with no change in serum potassium.
Danish: Hos raske voksne forsøgspersoner medførte patiromer en dosisafhængig stigning i den fækale udskillelse af kalium og en tilsvarende reduktion i udskillelsen af kalium i urinen uden ændring i serumkalium.
English: Other liquids cannot be used as they may contain high amounts of potassium.
Danish: Brug ikke andre væsker, da de kan indeholde store mængder kalium.
English: Figure 1: Mean (95% CI) serum potassium over time Baseline Serum K+ > 5.0 to 5.5 mEq/L
Danish: Figur 1: Gennemsnitlig (95 % CI) serumkalium over tid Baseline-serum K+ > 5,0 til 5,5 meq/l
English: Baseline, mean (SD) Week 4 Change from Baseline, Mean ± SE (95% CI) p value
Danish: Ændring ved uge 4 i forhold til baseline, gennemsnit ± SE (95 % CI) p-værdi
English: The mean daily doses of patiromer were 13 g and 21 g in patients with serum potassium of 5.1 to <5.5 mEq/L and 5.5 to <6.5 mEq/L, respectively.
Danish: Den gennemsnitlige daglige dosis af patiromer var 13 g og 21 g hos patienter med serumkalium på henholdsvis 5,1 til < 5,5 meq/l og 5,5 til < 6,5 meq/l.
English: The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest visit at which the patient's serum potassium was first outside of the range of 3.8 to <5.5 mEq/L or to Part B Week 4 if the patient's serum potassium remained in the range.
Danish: Det primære slutpunkt i Del B var ændringen i serumkalium fra baseline i Del B til det første besøg, hvor patientens serumkalium var uden for intervallet på 3,8 til < 5,5 meq/l, eller til uge 4 i Del B, hvis patientens serumkalium forblev i intervallet.
English: PHARMACEUTICAL FORM Powder for oral suspension.
Danish: Pulver til oral suspension.
English: Veltassa contains calcium as part of the counterion complex.
Danish: Veltassa indeholder calcium som en del af modion-komplekset.
English: Patients initiated spironolactone at 25 mg/day at the same time as their randomised treatment (patiromer 12.6 g BID or placebo), and were up-titrated to 50 mg/day after Day 14 if serum potassium was >3.5 and ≤5.1 mEq/L.
Danish: Patienterne startede med 25 mg spironolacton om dagen samtidig med deres randomiserede behandling (patiromer 12,6 g BID eller placebo) og blev optitreret til 50 mg/dag efter 14 dage, hvis serumkaliumniveauet var >3,5 og ≤5,1 mEq/l.
English: For the Part A secondary outcome, 76% (95% CI: 70%, 81%) of patients had a serum potassium in the target range of 3.8 mEq/L to <5.1 mEq/L at Part A Week 4.
Danish: For det sekundære resultat i Del A havde 76 % (95 % CI: 70 %, 81 %) af patienterne et niveau af serumkalium i målintervallet på 3,8 meq/l til < 5,1 meq/l ved uge 4 i Del A.
English: Follow-Up (day)
Danish: Opfølgni ng (dag)
English: 5.5 to <6.5 mEq/L (n=147) Serum Potassium (mEq/L)
Danish: 5,5 til < 6,5 meq/l (n=147) Serumkalium (meq/l)
English: • low blood magnesium seen in tests
Danish: • diarré mavesmerter luft i maven lavt indhold af magnesium i blodet påvist i prøver
English: More placebo patients (91% [95% CI: 83%, 99%]) developed a serum potassium ≥5.1 mEq/L at any time during Part B than patiromer patients (43% [95% CI: 30%, 56%]), p<0.001.
Danish: Der var flere patienter på placebo (91 % [95 % CI: 83 %, 99 %], der udviklede et niveau af serumkalium ≥ 5,1 meq/l på et hvilket som helst tidspunkt under Del B, end patienter på patiromer (43 % [95 % CI: 30 %, 56 %]), p < 0,001.
English: • problems swallowing
Danish: • problemer med at synke
English: The active substance is patiromer (as patiromer sorbitex calcium).
Danish: Aktivt stof: patiromer (som patiromersorbitexcalcium).
English: INFORMATION IN BRAILLE VELTASSA 25.2 G
Danish: INFORMATION I BRAILLESKRIFT VELTASSA 25,2 G
English: Check with your doctor or pharmacist if you are not sure.
Danish: Kontakt lægen eller apotekspersonalet, hvis du er i tvivl.
English: The mixture should be taken within 1 hour of initial suspension.
Danish: Blandingen skal indtages inden for 1 time efter klargøring af suspensionen.
English: Veltassa works by attaching to potassium in your gut.
Danish: Veltassa fungerer ved at binde sig til kalium i din tarm.
English: Serum potassium levels
Danish: Serumkaliumniveauer
English: Mean (95% Cl) Serum Potassium (mEq/L)
Danish: Gennemsnitlig (95 % Cl) serumkalium (meq/l)
English: • Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g of patiromer.
Danish: • Veltassa 25,2 g pulver til oral suspension: Hvert brev indeholder 25,2 g patiromer.
English: In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to <5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor treatment were randomised to continue patiromer or to receive placebo for 8 weeks to evaluate the effect of withdrawing patiromer on serum potassium.
Danish: I Del B blev 107 patienter, der i Del A havde et baseline-niveau af serumkalium på 5,5 meq/l til < 6,5 meq/l, og hvis niveau af serumkalium var i målintervallet (3,8 meq/l til < 5,1 meq/l) ved uge 4 i Del A, og som stadig fik behandling med en RAAS-inhibitor, randomiseret til at fortsætte med patiromer eller til at modtage placebo i 8 uger for at vurdere virkningen af ophør med patiromer på niveauet af serumkalium.
English: Veltassa contains sorbitol as part of the counterion complex.
Danish: Veltassa indeholder sorbitol som en del af modion-komplekset.
English: Patiromer increases faecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.
Danish: Patiromer øger den fækale udskillelse af kalium via binding af kalium i lumenen i mave-tarm-kanalen.
English: How to take Veltassa
Danish: Sådan skal du tage Veltassa
English: INFORMATION IN BRAILLE VELTASSA 8.4 G
Danish: INFORMATION I BRAILLESKRIFT VELTASSA 8,4 G
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: 5.3) tyder dyrestudier ikke på direkte eller indirekte skadelige virkninger.
English: Patients with a baseline serum potassium of 5.1 mEq/L to <5.5 mEq/L (mmol/L) received a starting dose of 8.4 g patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L received a starting dose of 16.8 g patiromer per day (as a divided dose).
Danish: Patienter med et baselineniveau af serumkalium på 5,1 meq/l til < 5,5 meq/l (mmol/l) fik en startdosis på 8,4 g patiromer pr. dag (som en opdelt dosis), og patienter med et baselineniveau af serumkalium på 5,5 meq/l til < 6,5 meq/l fik en startdosis på 16,8 g patiromer pr. dag (som en opdelt dosis).
English: In patients with a baseline serum potassium of >5.0 to 5.5 mEq/L who received an initial dose of 8.4 g patiromer per day, the mean daily dose was 14 g; in those with a baseline serum potassium of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g patiromer per day, the mean daily dose was 20 g during the entire study.
Danish: Hos patienter med baseline-serumkalium > 5,0 til 5,5 meq/l, der fik en startdosis på 8,4 g patiromer pr. dag, var den gennemsnitlige daglige dosis 14 g. Hos personer med baseline-serumkalium > 5,5 til < 6,0 meq/l, der fik en startdosis på 16,8 g patiromer pr. dag, var den gennemsnitlige daglige dosis 20 g under hele studiet.
English: INFORMATION IN BRAILLE VELTASSA 16.8 G
Danish: INFORMATION I BRAILLESKRIFT VELTASSA 16,8 G
English: Discontinuing patiromer
Danish: Ophør af behandling med patiromer
English: Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
Danish: Hvert brev indeholder 8,4 g patiromer (som patiromersorbitexcalcium) Hvert brev indeholder 16,8 g patiromer (som patiromersorbitexcalcium) Hvert brev indeholder 25,2 g patiromer (som patiromersorbitexcalcium)
English: If you miss more than one dose, contact your doctor.
Danish: Tal med din læge, hvis du har glemt mere end én dosis.
English: Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension patiromer (as patiromer sorbitex calcium)
Danish: Veltassa 8,4 g pulver til oral suspension Veltassa 16,8 g pulver til oral suspension Veltassa 25,2 g pulver til oral suspension patiromer (som patiromersorbitexcalcium)
English: • Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g of patiromer.
Danish: • Veltassa 16,8 g pulver til oral suspension: Hvert brev indeholder 16,8 g patiromer.
English: (CKD) on stable doses of at least one RAAS inhibitor (i.e. angiotensin converting enzyme inhibitor [ACEI], angiotensin II receptor blocker [ARB] or aldosterone antagonist [AA]).
Danish: Sikkerheden og virkningen af patiromer blev påvist i et todelt, enkelt-blindet, randomiseret seponeringsstudie, hvor denne behandling blev vurderet hos hyperkaliæmiske patienter med kronisk nyresygdom (CKD) på en stabil dosis af mindst én RAAS-inhibitor (dvs. en angiotensinomdannende enzymhæmmer [ACEI], angiotensin II-receptorblokker [ARB] eller aldosteronantagonist [AA]).
English: • levothyroxine: a medicine to treat thyroid hormone deficiency
Danish: • ciprofloxacin: et lægemiddel til behandling af bakterieinfektioner levothyroxin: et lægemiddel til behandling af mangel på skjoldbruskkirtelhormon metformin: et lægemiddel til behandling af diabetes quinidin: et lægemiddel til behandling af uregelmæssig hjerterytme.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 25.2 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - Veltassa 25,2 g
English: • Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer
Danish: • Veltassa 8,4 g pulver til oral suspension: Hvert brev indeholder 8,4 g patiromer.
English: Ask your doctor or pharmacist if you are not sure.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension
Danish: LÆGEMIDLETS NAVN Veltassa 8,4 g pulver til oral suspension Veltassa 16,8 g pulver til oral suspension Veltassa 25,2 g pulver til oral suspension
English: 3 years
Danish: 6.3 Opbevaringstid 3 år
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 16.8 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - Veltassa 16,8 g
English: Nausea Vomiting
Danish: Kvalme Opkastning
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager denne medicin hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 25.2 g powder for oral suspension patiromer
Danish: LÆGEMIDLETS NAVN Veltassa 25,2 g pulver til oral suspension patiromer
English: • diarrhoea
Danish: Forstoppelse Diarré
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 25,2 g patiromer (som patiromersorbitexcalcium)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 8.4 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - Veltassa 8,4 g
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/004 30 sachets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/17/1179/004 30 breve
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension patiromer
Danish: LÆGEMIDLETS NAVN Veltassa 8,4 g pulver til oral suspension patiromer
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/007 30 sachets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/17/1179/007 30 breve
English: NAME OF THE MEDICINAL PRODUCT Veltassa 16.8 g powder for oral suspension patiromer
Danish: LÆGEMIDLETS NAVN Veltassa 16,8 g pulver til oral suspension patiromer
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/001 30 sachets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/17/1179/001 30 breve
English: • starting dose: 8.4 g patiromer (the content of one 8.4 g sachet) once daily
Danish: Den anbefalede dosis er: startdosis: 8,4 g patiromer (indholdet af ét brev på 8,4 g) én gang dagligt maksimal dosis: 25,2 g patiromer (indholdet af ét brev på 25,2 g) én gang dagligt
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 16,8 g patiromer (som patiromersorbitexcalcium)
English: If powder remains in the glass after drinking,
Danish: Hvis der stadig er pulver tilbage i glasset, når du har drukket indholdet, skal du tilsætte mere vand, omrøre og drikke det med det samme.
English: Posology
Danish: Indtagelse
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 8,4 g patiromer (som patiromersorbitexcalcium)
English: More placebo patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥5.5 mEq/L at any time during
Danish: Der var flere patienter på placebo (60 % [95 % CI: 47 %, 74 %]), udviklede et niveau af serumkalium ≥ 5,5 meq/l på et hvilket som helst tidspunkt under Del B, end patienter på patiromer (15 % [95 % CI: 6 %, 24 %]), p < 0,001.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 25.2 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BREV med Veltassa 25,2 g
English: If you take more Veltassa than you should
Danish: Hvis du har taget for meget Veltassa
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 16.8 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BREV med Veltassa 16,8 g
English: EU/1/17/1179/008 60 sachets
Danish: EU/1/17/1179/008 60 breve
English: EU/1/17/1179/006 90 sachets
Danish: EU/1/17/1179/006 90 breve
English: What Veltassa is and what it is used for What you need to know before you take Veltassa How to take Veltassa
Danish: Det skal du vide, før du begynder at tage Veltassa Sådan skal du tage Veltassa Bivirkninger
English: EU/1/17/1179/009 90 sachets
Danish: EU/1/17/1179/009 90 breve
English: EU/1/17/1179/005 60 sachets
Danish: EU/1/17/1179/005 60 breve
English: EU/1/17/1179/003 90 sachets
Danish: EU/1/17/1179/003 90 breve
English: EU/1/17/1179/002 60 sachets
Danish: EU/1/17/1179/002 60 breve
English: The recommended dose is:
Danish: Oversigt over indlægssedlen:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 8.4 g
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BREV med Veltassa 8,4 g
English: Patients on dialysis
Danish: Patienter, der er i dialyse
English: 28x1 tablets l t o r
Danish: 28x1 tabletter t r
English: Package size blister (OPA/Al/PVC - Al), calendar
Danish: Pakningsstørrelse blister (OPA/Al/PVCAl), kalender
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Lægemiddelform Administrationsvej
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets (multipack)
Danish: 90 (3 x 30) tabletter (multipakning)
English: MA (EU) Numbers Invented name
Danish: MF (EU)-nummer
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold
English: 20 ml
Danish: Hætteglas (glas) 20 ml
English: Do not mix with other products.
Danish: Bør ikke blandes med andre produkter.
English: 16 months.
Danish: 16 måneder.
English: Apply the usual aseptic procedures.
Danish: Anvend sædvanlige aseptiske procedurer.
English: Concerned Member States:
Danish: Berørte medlemsstater:
English: After reconstitution: 2 hours.
Danish: Efter opløsning: 2 timer.
English: 08014 BARCELONE
Danish: 08014 BARCELONA
English: For more information, contact the manufacturer.
Danish: Producenten kan kontaktes for mere information.
English: ANNEX I SCIENTIFIC CONCLUSIONS PRESENTED BY THE EMEA
Danish: BILAG I FAGLIGE KONKLUSIONER FREMLAGT AF EMEA
English: Duration of immunity induced by the vaccination scheme described under 5.7 : protection until the age of 6 weeks.
Danish: Varighed af immunitet i henhold til vaccinationsskemaet beskrevet under 5.7 : beskyttelse indtil 6ugers alderen.
English: The CVMP considered the written responses provided by the Applicant, the joint Rapporteur-CoRapporteur's assessment report on the response of the Applicant and the comments from CVMP members.
Danish: CVMP behandlede de skriftlige besvarelser fra ansøgeren, vurderingsrapporten fra den fælles rapportør/medrapportøren vedrørende ansøgerens besvarelse og bemærkningerne fra CVMP's medlemmer.
English: Hands should be washed and disinfected after vaccinating.
Danish: Hænder bør vaskes og desinficeres efter vaccination.
English: Store between 2°C and 8°C, protected from light.
Danish: Opbevares mellem 2oC og 8oC, beskyttet for lys.
English: The basis for arbitration procedure was the withdrawal period of zero days.
Danish: Grundlaget for voldgiftsproceduren var tilbageholdelsestiden på 0 dage.
English: No side-effect has been observed following administration of 10 times the recommended dose of vaccine.
Danish: Ingen bivirkninger er observeret efter administration af 10 gange den anbefalede vaccinedosis.
English: It is, therefore, recommended that no other vaccines should be administered within 14 days before or after vaccination with Avinew.
Danish: Derfor anbefales det ikke at anvende andre vacciner inden for 14 dage før eller efter vaccination med Avinew.
English: ANNEX II LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES
Danish: BILAG II LISTE OVER VETERINÆRLÆGEMIDLETS LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, EMBALLAGE OG PAKNINGSSTØRRELSER I MEDLEMSSTATERNE
English: • the removal of the main sources of virus (i.e. intestines and upper respiratory tract) in the processing plant;
Danish: • fjernelsen af de vigtigste viruskilder (dvs. tarme og øvre luftveje) i forarbejdningsanlægget;
English: Concern was expressed by the Netherlands, that a withdrawal time of zero days would not be acceptable.
Danish: Nederlandene udtrykte bekymring for, at en tilbageholdelsestid på 0 dage ikke kunne accepteres.
English: Sandringham House Harlow Business Park ESSEX CM 19 5TG UNITED KINGDOM
Danish: Sandringham House Harlow Business Park ESSEX CM 19 5TG DET FORENEDE KONGERIGE
English: Birds should be deprived of water for two hours prior to vaccination.
Danish: Fuglene bør være uden vand i 2 timer før vaccinationen.
English: I RELAND
Danish: I RLAND
English: Powder for suspension
Danish: Pulver til mikstur, suspension
English: Av. Maria Lamas, Lote 19 - BL.
Danish: Av. Maria Lamas, Lote 19 - BL. A Piso
English: Because Newcastle disease virus can cause a transitory conjunctivitis in man, it is recommended to wear respiratory and eye protection in compliance with current European standards.
Danish: Fordi Newcastle disease virus kan forårsage forbigående konjunktivitis hos mennesker, anbefales det at bære beskyttelse af respirationsveje og øjne i overensstemmelse med gældende europæiske standarder.
English: The virus titre required to produce infection in 50 % of the embryos inoculated
Danish: Den virustiterværdi, som er nødvendig for at foretage infektion i 50% af de inokulerede embryoer.
English: Place one drop of the vaccine solution on the eye of each bird, allow the drop to spread and release the bird.
Danish: Placer en dråbe af vaccineopløsningen på øjet af hver fugl, lad dråben brede sig og frigør fuglen.
English: For the preparation and administration of the vaccine, use sterile material free from disinfectant and/or antiseptic.
Danish: Til fremstilling og administration af vaccinen, skal anvendes sterilt materiale fri for desinficerende og/eller antiseptisk middel.
English: The presence of disinfectant and/or antiseptic in water and material used for the preparation of vaccine solution is not compatible with an effective vaccination.
Danish: Tilstedeværelsen af desinficerende og/eller antiseptisk middel i vand og materiale, der anvendes til fremstilling af vaccineopløsningen, er ikke forenelig med en effektiv vaccination.
English: 5.10 Withdrawal periods
Danish: 5.10 Tilbageholdelsestid
English: Spray the vaccine solution above the birds using a spray capable of producing micro-droplets (mean diameter 80-100 µm).
Danish: Vaccineopløsningen sprøjtes ud over fuglene, idet der anvendes en sprøjte der kan producere microdråber (gennemsnitlig diameter 80-100 µm).
English: Considering the product to be a live vaccine with a zoonotic agent and the fact that live Newcastle Disease virus was found in the cloaca and trachea of vaccinated birds up to 8 days after vaccination, a withdrawal period of 7 days was considered acceptable by the Netherlands.
Danish: I betragtning af, at produktet var en levende vaccine med en zoonotisk agens, og at der var fundet levende Newcastle disease virus i cloaca og trachea på vaccinerede fugle i op til 8 dage efter vaccinationen, blev en tilbageholdelsestid på 7 dage anset for rimelig af Nederlandene.
English: LUXEM BURG
Danish: LUXEM BOURG
English: Moreover, a reversion to virulence trial carried out in the laboratory has shown that the vaccine virus does not acquire any pathogenic characteristic after 10 passages in chickens.
Danish: Endvidere har en laboratorieundersøgelse af reversion til virulens vist, at vaccinevirus ikke giver nogen patogene karakteristika efter 10 passager i kyllinger.
English: Infection of unvaccinated birds with the vaccine virus from vaccinated birds does not induce any sign of disease.
Danish: Infektion af uvaccinerede fugle med vaccinevirus fra vaccinerede fugle giver ingen tegn på sygdom.
English: Vaccine virus can spread to unvaccinated birds.
Danish: Vaccinevirus kan spredes til uvaccinerede fugle.
English: Marketing authorization holder : MERIAL
Danish: Indehaver af markedsføringstilladelse: MERIAL
English: The ventilation system of the poultry house should be inoperative during the spray administration.
Danish: Ventilationssystemet i fjerkræstalden skal være ude af funktion under sprøjtningen.
English: Care should be taken when handling the vaccine preparation.
Danish: Der bør udvises forsigtighed i omgang med vaccinen.
English: The VG/GA strain is lentogenic and naturally apathogenic for chickens.
Danish: VG/GA stammen er lentogen og naturlig apatogen for kyllinger.
English: Active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.
Danish: − Aktiv immunisering over for Newcastle disease for at reducere dødelighed og kliniske symptomer i tilslutning til sygdommen.
English: When using mains water, treat all water to come into contact with the vaccine with skimmed milk powder at a rate of 2.5 g per litre in order to neutralise traces of chlorine.
Danish: Når der anvendes vand fra hovedledningen, skal al vand der kommer i kontakt med vaccinen behandles med skummetmælkspulver i en mængde på 2,5 g/l for at neutralisere spor af klor.
English: Therefore, the CVMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics is set out in Annex III for Avinew.
Danish: Derfor har CVMP anbefalet, at der udstedes markedsføringstilladelse(r) for Avinew.
English: 2000 doses
Danish: 2000 doser
English: The vaccine induces active immunisation against Newcastle disease, as demonstrated by challenge test.
Danish: Vaccinen inducerer aktiv immunitet over for Newcastle disease vist ved challenge test.