FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you have a history of blood clots (thrombosis) or have risk factors for blood clots (these risk factors and symptoms for a blood clot are listed in section 4,“Other side effects of combined
Danish: (Disse risikofaktorer samt symptomer på blodpropper er anført under pkt.
English: BEFORE YOU TAKE ACTIVELLE
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ACTIVELLE
English: Marszałka J. Piłsudskiego 5 95-200 Pabianice
Danish: Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
English: Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Danish: TEVA PHARMA BELGIUM NV Laarstraat 16
English: ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR
Danish: Grækenland ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR
English: S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România
Danish: Rumænien S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România
English: Sweden sanofi-aventis AB Box 14142
Danish: Sverige sanofi-aventis AB Box 14142
English: Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland
Danish: Storbritannien Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland
English: Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Danish: Letland sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
English: IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564 Greece
Danish: Grækenland IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564
English: SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
Danish: Grækenland SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
English: 1526 Ljubljana Slovenia
Danish: 1526 Ljubljana
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Danish: Danmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
English: Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Danish: Østrig ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
English: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Danish: Storbritannien Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
English: Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Danish: Tyskland neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
English: Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Danish: Østrig sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
English: Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
Danish: Storbritannien Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Danish: Storbritannien Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
English: Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
Danish: Storbritannien Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
English: B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
Danish: Rumænien LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
English: Czech Republic Generics [UK] Ltd. Station Close
Danish: Storbritannien Generics [UK] Ltd. Station Close
English: Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Danish: Grækenland ITF HELLAS S.A. Areos 103 and Ag. Triados 36, Palaio Faliro 17562
English: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Danish: Storbritannien Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4
English: Poligono Industrial Areta .Huarte-Pamplona (Navarra)
Danish: LABORATORIOS CINFA, S.A. OlazChipi, 10. Poligono Industrial Areta .Huarte-Pamplona (Navarra)
English: Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Danish: SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Danish: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
English: Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Danish: MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Danish: Holland ratiopharm Nederland B.V.
English: Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Danish: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Danish: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Danish: Telecom Gardens Medialaan 40
English: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Danish: Storbritannien Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22
English: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
Danish: Storbritannien Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
English: H-1056, Budapest Duna u.1
Danish: H-1056, Budapest
English: Czech Republic Krka, d.d., Novo mesto Šmarješka cesta 6
Danish: Slovenien Krka, d.d., Novo mesto Šmarješka cesta 6
English: LEK farmacevtska družba d.d.
Danish: Rumænien LEK farmacevtska družba d.d.
English: SANOFI-AVENTIS ROMÂNIA S.R.L.
Danish: Rumænien SANOFI-AVENTIS ROMÂNIA S.R.L.
English: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Danish: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Danish: Slovakiet sanofi-aventis Slovakia s.r.o.
English: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Danish: Storbritannien Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
English: 10 mg/ml oral drops, solution oral use
Danish: 10 mg/ml orale dråber, opløsning
English: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Danish: 92931 Paris La Défense Cedex FRANCE
English: Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
Danish: Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
English: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
Danish: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g. LT-09310 Vilnius Lithuania
English: Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Danish: Bulgarien Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd.
English: Luxembourg Apotex Europe B.V. Darwinweg 20
Danish: Luxembourg Apotex Europe B.V.
English: Czech Republic MEDA Pharma s.r.o.
Danish: MEDA Pharma s.r.o.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Danish: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
English: Zolpidem Genthion coated tablet oral use
Danish: Zolpidem Genthion overtrukken tablet Oral anvendelse
English: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Danish: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten brusetablet
English: Czech Republic Vitabalans Oy Varastokatu 8
Danish: Slovenien Vitabalans Oy Varastokatu 8
English: Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Danish: Storbritannien ratiopharm GmbH Graf Arco Strasse 3
English: Czech Republic ALKALOID-INT d.o.o.
Danish: Storbritannien ALKALOID-INT d.o.o.
English: Dodorest coated tablet oral use
Danish: Dodorest overtrukken tablet Oral anvendelse
English: Apotex Europe B.V. Darwinweg 20
Danish: Apotex Europe B.V.
English: Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Danish: Stilnoct 5mg fiilm-coated tablets overtrukken tablet Oral anvendelse
English: 110 00 Prague 10
Danish: Kodaňská 1441/46 110 00 Prague 10
English: Stilnoct, tabletten 10 mg tablet oral use
Danish: Stilnoct, tabletten 10 mg tablet
English: Stilnoct 10mg film-coated tablets coated tablet oral use
Danish: Stilnoct 10mg film-coated tablets overtrukken tablet Oral anvendelse
English: Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Danish: Takeda GmbH 2 Byk-Gulden Strasse
English: Stilnoct tablet oral use
Danish: Stilnoct overtrukken tablet Oral anvendelse
English: Zolsana 10 mg coated tablets coated tablet oral use
Danish: Zolsana 10 mg coated tablets overtrukken tablet Oral anvendelse
English: tablet oral use
Danish: overtrukken tablet Oral anvendelse
English: Zolsana 5 mg coated tablets coated tablet oral use
Danish: Zolsana 5 mg coated tablets overtrukken tablet Oral anvendelse
English: Zolpitop coated tablet oral use
Danish: Zolpitop overtrukken tablet Oral anvendelse
English: ADORMA 5 mg filmom obalené tablety 5 mg
Danish: ADORMA 5 mg filmom obalené tablety
English: Czech Republic SANDOZ s.r.o.
Danish: SANDOZ s.r.o.
English: Sanval 10 mg filmsko obožene tablete 10 mg
Danish: Sanval 10 mg filmsko obožene tablete
English: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Danish: Zolpidemtartraat ADOH 10 mg, bruistabletten brusetablet
English: Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Danish: Edluar 10 mg, tablet voor sublinguaal gebruik resoriblet
English: Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Danish: Edluar 5 mg, tablet voor sublinguaal gebruik resoriblet
English: Zolpidem "Hexal" - Filmtabletten
Danish: Zolpidem "Hexal" - Filmtabletten 10 mg
English: Italfarmaco S.p.A. Viale Fulvio 330 20126 Milano Italy
Danish: Viale Fulvio 330 20126 Milano Italy
English: Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Danish: Zolpidemtartaat Actavis 5 mg, tabletten tablet
English: ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italy
Danish: Viale Fulvio Testi 330, 20126 Milano, Italy
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Danish: Edluar 10 mg Sublingualtabletten 10 mg resoriblet
English: Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Danish: Zolpidemtartraat Actavis 10 mg, tabletten tablet
English: Sanval 10 mg filmom obložene tablete 10 mg
Danish: Sanval 10 mg filmom obložene tablete
English: Lunata 10 mg filmom obložene tablete 10 mg
Danish: Lunata 10 mg filmom obložene tablete
English: Zolpidem-CT 5 mg Filmtabletten
Danish: Zolpidem-CT 5 mg Filmtabletten 5 mg
English: sublingual tablet sublingual use
Danish: Sublingual anvendelse
English: Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Danish: Zolpidem-Actavis 10 mg Filmtabletten
English: Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Danish: Zolpidem Sandoz 10 mg Filmtabletten
English: Zoldem 10 mg film coated tablets
Danish: Zoldem 10 mg film coated tablets 10 mg
English: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Danish: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet
English: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Danish: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet
English: EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Danish: EDLUAR 10 mg nyelvalatti tabletta 10 mg resoriblet
English: Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Danish: Sverige ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Danish: Tyskland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolsana 5 mg filmsko obložene tablete 5 mg
Danish: Zolsana 5 mg filmsko obložene tablete
English: Zolsana 5 mg filmom obložene tablete 5 mg
Danish: Zolsana 5 mg filmom obložene tablete
English: INSOM 10 mg pezsgőtabletta effervescent tablet oral use
Danish: INSOM 10 mg pezsgőtabletta brusetablet
English: The European Commission issued a decision on 5 October 2010.
Danish: Europa-Kommissionen vedtog en beslutning den 5. oktober 2010.
English: The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Danish: Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Bulgarien, Tyskland, Frankrig, Irland og Italien ("de berørte medlemsstater").
English: Kristina Dunder (Sweden)
Danish: Kristina Dunder (Sverige)
English: Daniela Melchiorri (Italy)
Danish: Daniela Melchiorri (Italien)
English: What is Norsed Combi D?
Danish: Hvad er Norsed Combi D?
English: The grounds for the referral were concerns over the evidence provided of the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
Danish: Begrundelserne for indbringelsen var betænkeligheder med hensyn til dokumentationen for virkningen af dette kombinationslægemiddel, gyldigheden af påstandene om, at denne måde at kombinere aktive stoffer på ville være til fordel for patienterne sammenlignet med de enkelte aktive stoffer, og gyldigheden af påstandene om, at lægemidlet skabte bedre overensstemmelse (patienternes evne til at overholde behandlingen).
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den regulerende myndighed for lægemidler i Sverige indbragte den 29. april 2010 sagen for CHMP med henblik på voldgift.
English: Why was Norsed Combi D reviewed?
Danish: Hvorfor blev Norsed Combi D vurderet igen?
English: 5 October 2010
Danish: 5. oktober 2010
English: 20 May 2010
Danish: 20. maj 2010
English: Blocking the action of these cells leads to less bone loss.
Danish: Når aktiviteten af disse celler hæmmes, sker der mindre tab af knoglemasse.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Norsed Combi D outweigh its risks, and therefore the marketing authorisation for Norsed Combi D should be granted in all concerned Member States.
Danish: På baggrund af en vurdering af de tilgængelige data og den videnskabelige diskussion i udvalget konkluderede CHMP, at fordelene ved Norsed Combi D er større end risiciene, og at markedsføringstilladelsen for Norsed Combi D derfor bør udstedes i alle de berørte medlemsstater.
English: It is used to reduce the risk of fractures (in the hip and spine.
Danish: Det bruges til at reducere risikoen for frakturer i hoften og ryggraden.
English: The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Danish: De aktive stoffer i brusegranulatet tilfører calcium og D-vitamin, som er nødvendige for normal knogledannelse.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Norsed Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Norsed Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in other Member States of the EU.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Norsed Combi D. EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Norsed Combi D er større end risiciene, og at den markedsføringstilladelse, der er udstedt i Sverige, kan anerkendes i andre EU-medlemsstater.
English: It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol.
Danish: Det består af tabletter, der indeholder 35 mg risedronatnatrium, sammen med breve af brusegranulat, der indeholder 1000 mg calcium som calciumcarbonat og 880 IE colecalciferol.
English: Norsed Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Norsed Combi D anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos postklimakterielle kvinder.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Danish: Det hæmmer aktiviteten af osteoklasterne, som er de celler, der er med til at nedbryde knoglevævet.
English: The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Danish: Det aktive stof i tabletterne, risedronatnatrium, er et bifosfonat.
English: Norsed Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol.
Danish: Norsed Combi D er et lægemiddel, der indeholder de tre aktive stoffer risedronatnatrium, calciumcarbonat og colecalciferol.
English: Sanofi-aventis S.p.A. submitted Norsed Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006.
Danish: ansøgte om gensidig anerkendelse for Norsed Combi D på baggrund af den første markedsføringstilladelse, der blev udstedt af Sverige den 3. oktober 2006.
English: Co-rapporteur:
Danish: Medrapportør:
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Danish: MF (EU)-nummer (Særnavn) navn Styrke Lægemiddelform Administration
English: These measures should help to protect the environment.
Danish: Disse foranstaltninger skal hjælpe med til at beskytte miljøet.
English: Their effect is essentially confined to rapidly dividing organisms.
Danish: Deres virkning er i alt væsentligt begrænset til hurtigtdelende organismer.
English: Treatment of PPE (ileitis)
Danish: Behandling af PPE (ileitis)
English: Tylvalosin has a sixteen membered ring.
Danish: Tylvalosin har en sekstenleddet ring.
English: Opened bags should not be stored.
Danish: Åbnede poser må ikke opbevares.
English: Where feed intake is reduced, use the following formula:
Danish: Hvor fødeindtagelsen er reduceret, anvendes den følgende formel:
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Spørg din dyrlæge, hvordan du bortskaffer lægemidler, der ikke længere er påkrævet.
English: In order to obtain the correct dose, the concentration of Aivlosin has to be adjusted accordingly.
Danish: For at opnå den korrekte dosis skal koncentrationen af Aivlosin justeres i overensstemmelse hermed.
English: One additional yearly periodic safety update report (PSUR) is required, and thereafter PSURs shall be submitted at three-yearly intervals, unless otherwise required.
Danish: Yderligere én årlig periodisk sikkerhedsindberetning (PSUR) er påkrævet, og derefter skal PSUR'er indsendes med tre års mellemrum, medmindre andet kræves.
English: Bacteria can develop resistance to antimicrobial substances.
Danish: Bakterier kan udvikle resistens over for antimikrobielle stoffer.
English: Keep the bag tightly closed.
Danish: Hold posen tæt tillukket.
English: Wash contaminated skin.
Danish: Vask kontamineret hud.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: Consideration must be given to pigs whose daily feed intake is reduced or restricted.
Danish: Der skal tages hensyn til svin, hvis daglige foderration er nedsat eller begrænset.
English: Once opened use immediately.
Danish: Efter åbning anvendes straks
English: OTHER CONDITIONS:
Danish: • ANDRE BETINGELSER:
English: Calculate the total amount of product required with the formula:
Danish: Beregn den totale mængde nødvendigt produkt ved hjælp af den følgende formel:
English: Keep the container tightly closed.
Danish: Hold beholderen tæt tillukket.
English: The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
Danish: Den vigtigste metabolit af tylvalosin er 3-acetyltylosin (3AT), som også er mikrobiologisk aktiv.
English: The intake of medicated water depends on the clinical condition of the animals.
Danish: Indtagelsen af medicineret vand afhænger af dyrenes kliniske tilstand.
English: The tmax for tylvalosin is about 2.2 hours; the terminal half-life for the elimination is approximately 2.2 hours.
Danish: Tmax for tylvalosin er cirka 2,2 timer; den terminale eliminationshalveringstid er cirka 2,2 timer.
English: No breakpoint for Brachyspira hyodysenteriae has been established.
Danish: Der er ikke fastlagt nogen tærskelværdi for Brachyspira hyodysenteriae.
English: 10 days
Danish: 10 dage
English: They bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Danish: De binder sig til donorstedet og forhindrer den translokation, der er nødvendig for fortsat vækst af peptidkæden.
English: ATCvet code: QJ01FA92.
Danish: ATCvet-kode: QJ01FA92
English: Date of first authorisation: 9 September 2004.
Danish: Dato for første markedsføringstilladelse: 9. september 2004.
English: The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight.
Danish: Det svin, der skal behandles, skal vejes, og den mængde foder, svinet sandsynligvis vil indtage, skal estimeres ud fra det daglige foderindtag svarende til 5% af legemsvægten.
English: These studies demonstrated a modest but statistically significant reduction in the incidence of lower respiratory lesions (lung and air sac) and clinical signs in turkeys treated with tylvalosin compared with negative controls.
Danish: Disse undersøgelser viste en beskeden, men statistisk signifikant reduktion i forekomsten af lavere respiratoriske læsioner (lunge og luftsæk) og kliniske tegn hos kalkuner behandlet med tylvalosin sammenlignet med negative kontroller.
English: The clinical relevance of this reduced susceptibility is not fully explored.
Danish: Den kliniske relevans af denne nedsatte følsomhed er ikke undersøgt fuldt ud.
English: Tylvalosin (as tylvalosin tartrate)
Danish: Tylvalosin (som tylvalosintartrat)
English: The strategy for Mycoplasma gallisepticum infection should include efforts to eliminate the pathogen from the parent generation.
Danish: Strategien for Mycoplasma gallisepticum-infektion bør omfatte bestræbelser på at eliminere patogenet fra forældregenerationen.
English: Duration of treatment
Danish: Behandlings -varighed
English: In vitro metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-Oacetyltylosin.
Danish: Metabolismeundersøgelser in vitro har bekræftet, at udgangsstoffet hurtigt metaboliseres til 3-Oacetyltylosin.
English: Muscle Skin and fat Liver
Danish: Muskler Hud og fedt Lever
English: The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
Danish: Foderet med det orale pulver skal være den eneste foderration i de ovenfor anbefalede perioder.