FrancophonIA/ELRC3.0 huggingface dataset:
English: Lithuania Franvet, Zone Industrielle d'Etriché, 49500 Segré, France
Danish: Zone Industrielle d'Etriché, 49500 Segré, Frankrig
English: The general acceptance of the fact that antimicrobial treatment needs always to be combined with appropriate management and sanitary measures on the farm, to prevent the further spread of any particular microbe and thus reduce the risk for new clinical cases, makes it difficult to defend a need for very long treatment periods.
Danish: Det er almindelig anerkendt, at antimikrobiel behandling altid må kombineres med hensigtsmæssige sundhedsmæssige foranstaltninger på bedriften for at forhindre yderligere spredning af en given mikroorganisme og begrænse risikoen for nye kliniske tilfælde.
English: 200 AVENUE DE MAYENNE ZONE INDUSTRIELLE DES TOUCHES
Danish: Frankrig SOGEVAL 200 AVENUE DE MAYENNE ZONE INDUSTRIELLE DES TOUCHES 53000 LAVAL
English: Germany KLAT-Chemie GmbH Visbeker Str. 12
Danish: Tyskland KLAT-Chemie GmbH Visbeker Str. 12
English: Riudoms (Tarragona) Spain
Danish: Riudoms (Tarragona) Spanien
English: RIUDOMS (Tarragona) Spain
Danish: RIUDOMS (Tarragona) Spanien
English: Indication for treatment of swine dysentery caused by Brachyspira hyodysenteriae
Danish: Indikationen behandling af svinedysenteri forårsaget af Brachyspira hyodysenteriae
English: de la Industria, nº 30 Polígono Industrial de Alcobendas
Danish: de la Industria, nº 30
English: Rua Doutor António Loureiro Borges, 9/9A - 9ºA Miraflores, 1495-131 Algés Portugal
Danish: Rua Doutor António Loureiro Borges, 9/9A - 9ºA
English: 3991 RA Houten The Netherlands
Danish: 3991 RA Houten
English: Pharma SIS 4 San Stefano Str. Dobrich
Danish: Bulgarien Pharma SIS 4 San Stefano Str.
English: MEVET, S. A.U.
Danish: Spanien MEVET, S. A.U.
English: 40 000 000 IU (50g) Powder for oral solution
Danish: 40 000 000 IU (50g) Pulver til oral opløsning
English: 20864 Agrate Brianza (MB) Italy
Danish: 20864 Agrate Brianza (MB) Italien
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Danish: Videnskabelige konklusioner og begrundelse for ændring af produktresuméerne, etiketteringen og indlægssedlerne
English: S.C. PASTEUR -FILIALA FILIPESTI
Danish: Rumænien S.C. PASTEUR -FILIALA FILIPESTI Str. Principala, nr. 944
English: Vanatyl-Pulver für Tiere
Danish: Vanatyl-Pulver für Tiere Tylosin
English: SOGETYL 100 MUI POUDRE POUR SO LUTION BUVABLE POUR VEAUX PORCINS ET VOLAILLE
Danish: SOGETYL 100 MUI POUDRE POUR SOLUTION BUVABLE POUR VEAUX PORCINS ET VOLAILLE
English: The excessive use over time may explain the high proportion of resistance in B. hyodysenteriae strains, the cause for swine dysentery, reported from many European countries today.
Danish: Langstrakt overforbrug kan være forklaringen på, at der i dag fra mange europæiske lande indberettes en høj resistensandel i stammer af B. hyodysenteriae, årsagen til svinedysenteri.
English: 20 g/100 g powder Premix for medicated feeding stuff
Danish: 20 g/100 g powder Premix til medicineret foder
English: 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE France
Danish: Frankrig QALIAN 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE Frankrig
English: Thus, to state that the administration of oral tylosin for pigs should not exceed three weeks is likely to assure sufficient treatment efficacy for currently authorised indications in pigs and this measure would also satisfy the requirement to avoid unnecessary exposure and thus reduce the risk for resistance development.
Danish: En maksimal behandlingstid på tre uger for oralt tylosin til svin må derfor forventes at give tilstrækkelig behandlingsvirkning til de aktuelt godkendte indikationer for svin og vil desuden opfylde kravet om undgåelse af unødig eksponering og dermed risikoen for resistensudvikling.
English: Str. Principala, nr. 944 Filipestii de Padure, Jud.
Danish: Filipestii de Padure, Jud.
English: 4941 VX Raamsdonkveer The Netherlands
Danish: 4941 VX Raamsdonkveer Nederlandene
English: Tilsol 200, 200 g/1000g
Danish: Tilsol 200, 200 g/1000g Tylosin
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 12: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Danish: Hvis indikationerne for et produkt ikke angiver svinedysenteri, men heller ikke udelukker det, tilføjes følgende sætning i punkt 12: Der er påvist høj andel af in vitro-resistens i europæiske stammer af Brachyspira hyodysenteriae, hvilket er et tegn på, at produktet ikke vil være tilstrækkelig effektivt mod svinedysenteri.
English: 100 000 000 IU/jar Granules for oral solution
Danish: 100 000 000 IU/jar Granulat til oral opløsning
English: E-08950 Esplugues de Llobregat, Barcelona Spain
Danish: E-08950 Esplugues de Llobregat, Barcelona
English: NL-4941 VX Raamsdonksveer The Netherlands
Danish: NL-4941 VX Raamsdonksveer Nederlandene
English: 20 g/100 g powder Powder for oral solution
Danish: 20 g/100 g powder Pulver til oral opløsning
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Danish: Ændringer i de relevante afsnit af produktresuméet, etiketteringen og indlægssedlen
English: Lithuania Chemifarma S.p.A.
Danish: Rumænien Chemifarma S.p.A.
English: Denmark Elanco Animal Health A/S Eli Lilly Danmark A/S Lyskaer 3E, 2 tv.
Danish: Danmark Elanco Animal Health A/S Eli Lilly Danmark A/S Lyskaer 3E, 2 tv.
English: 08520 Les Franqueses del Valles (Barcelona) Spain
Danish: 08520 Les Franqueses del Valles (Barcelona)
English: 08150 Parets del Valles (Barcelona)
Danish: 08150 Parets del Valles (Barcelona) Spanien
English: It is however acknowledged that, regardless of the indication, for most oral tylosin formulations authorised for pigs at present the maximum recommended treatment duration is three weeks, indicating that this has in many cases been concluded to be a sufficient treatment period.
Danish: Den anbefalede maksimale behandlingsvarighed er imidlertid tre uger for de fleste orale formuleringer af tylosin til svin uanset indikation, hvilket tyder på, at denne behandlingsperiode i mange tilfælde er fundet tilstrækkelig.
English: In the CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in foodproducing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)
Danish: I CVMP's oplæg om anvendelse af makrolider, lincosamider og streptograminer (MLS) hos fødevareproducerende dyr i EU: resistensudvikling og betydningen heraf for menneskers og dyrs helbred (EMA/CVMP/SAGAM/741087/2009)
English: and Hidalgo et al. (2009) 6, that 90-100% of Brachyspira isolates demonstrate in vitro resistance.
Danish: og Hidalgo et al. (2009) 6, at 90-100 % af
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 4.5: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Hvis indikationerne for et produkt ikke angiver svinedysenteri, men heller ikke udelukker det, tilføjes følgende sætning i punkt 4.5: Der er påvist høj andel af in vitro-resistens i europæiske stammer af Brachyspira hyodysenteriae som tegn på, at produktet ikke vil være tilstrækkelig effektivt mod svinedysenteri.
English: Dr. Franje Tuđmana 3 10431, Sveta Nedelja Croatia
Danish: 10431, Sveta Nedelja Kroatien
English: S.P. VETERINARIA, S.A. CTRA.
Danish: Spanien S.P. VETERINARIA, S.A. Ctra.
English: Tylan 20 mg/g - ArzneimittelVormischung zur Herstellung von Fütterungsarzneimitteln für Schweine
Danish: Tylan 20 mg/gArzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Danish: Begrundelse for ændring af produktresuméet, etiketteringen og indlægssedlerne
English: 110 g tylosin tartate per 110 g powder (= 100 g tylosin-base)
Danish: 110 g tylosin tartate per 110 g powder (= 100 g tylosinbase)
English: TILOSINA 100 GANADEXIL
Danish: TILOSINA 100 GANADEXIL Tylosin
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 12 should be added: For information regarding swine dysentery see section 12.
Danish: Hvis indikationen eller indikationerne for et produkt ikke nævner svinedysenteri, man heller ikke udelukker det, tilføjes en krydshenvisning til afsnit 12: Se afsnit 12 vedrørende svinedysenteri.
English: Ceva Salute Animale S.p.A. Viale Colleoni, 15
Danish: Viale Colleoni, 15
English: TYLO 20 PM PORC VOLAILLE Tylosin phosphate
Danish: TYLO 20 PM PORC VOLAILLE
English: TRELACON G 250 PREMEZCLA Tylosin
Danish: TRELACON G 250 PREMEZCLA
English: LABORATORIOS MAYMO VIA AUGUSTA 302 08017 BARCELONA Spain
Danish: Frankrig LABORATORIOS MAYMO VIA AUGUSTA 302
English: IRIS Mednarodna trgovina d.o.o.,
Danish: Slovenien IRIS Mednarodna trgovina d.o.o., Cesta v Gorice 8
English: Elanco Animal Health Kölblgasse 8-10
Danish: Elanco Animal Health Grootslag 1-5
English: TYLOSINA BMP Powder Τylosin (from tylosin tartrate) 200 g/Kg
Danish: TYLOSINA BMP Powder Τylosin (from tylosin tartrate) 200 g/Kg Φαρμακούχο πρόμιγμα σε κόκκους για χοίρους και κοτόπουλα κρεωπαραγωγής
English: PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS
Danish: PHARMASIN 20 G/KG PREMELANGE MEDICAMENTEUX VOLAILLE PORCS
English: Pigs and chickens (not producing eggs for human consumption)
Danish: Svin, kyllinger (som ikke producerer æg til konsum)
English: Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf requirements can be made available, that would provide convincing support for specific dosing strategies for currently accepted indications for oral tylosin formulations for pigs.
Danish: Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf
English: TRELACON G 50 PREMEZCLA Tylosin
Danish: TRELACON G 50 PREMEZCLA
English: Germany Dopharma Research B.V. Zalmweg 24
Danish: Tyskland Dopharma Research B.V.
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 4.5 should be added: For information regarding swine dysentery see section 4.5.
Danish: Hvis indikationen eller indikationerne for et produkt ikke nævner svinedysenteri, man heller ikke udelukker det, tilføjes en krydshenvisning til afsnit 4.5: Se pkt.
English: 100 000 000 IU/jar Powder for oral solution
Danish: 100 000 000 IU/jar Pulver til oral opløsning
English: CONCENTRAT V007 TYLAN 100 Tylosin phosphate
Danish: CONCENTRAT V007 TYLAN
English: Lithuania Dopharma Research B.V. Zalmweg 24, 4941 VX Raamsdonksveer, the Netherlands
Danish: Zalmweg 24, 4941 VX Raamsdonksveer, Nederlandene
English: Hens and pigs
Danish: Høns og svin
English: Tylan powder for oral solution Tylosin
Danish: Tylan powder for oral solution
English: TYLAN vodorozpustný prášok Tylosin tartarate
Danish: HIDROTIL POLVO ORAL Tylosin tartarate
English: Kownaty 74
Danish: Zalmweg 24
English: It is acknowledged that for certain holdings where susceptibility of B. hyodysenteriae to tylosin is still evident a removal of this indication would restrict the availability of treatment options.
Danish: Det vedgås, at sletning af denne indikation vil indskrænke behandlingsmulighederne på visse bedrifter, hvor der stadig er tylosinfølsomme B. hyodysenteriae.
English: Eli Lilly Regional Operations GmbH
Danish: Rumænien Eli Lilly Regional Operations GmbH Elanco Animal Health
English: Pharmasin 100 mg/g Premix Tylosin phosphate
Danish: TYLAN 100 mg/g premix Tylosin phosphate
English: Non ruminating calves, pigs, poultry
Danish: Ikkedrøvtyggende kalve, svin, fjerkræ
English: Dopharma Reasearch B.V. Zalmweg 24
Danish: Nederlandene Dopharma Reasearch B.V.
English: Cattle, goats, sheep, pigs, poultry
Danish: Kvæg, geder, får, svin, fjerkræ
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Markiesstraat 1
Danish: Elanco Animal Health Markiesstraat 1
English: Given that, as stated in the above mentioned CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009), this substance class is critically important for veterinary medicine and for human use and, furthermore, that the development of resistance is reported for veterinary pathogens as well as zoonotic pathogens such as Campylobacter spp, extended treatment of pigs beyond what can be regarded medically motivated must be avoided.
Danish: På baggrund af, hvad der anføres i det nævnte oplæg fra CVMP om anvendelse af makrolider, lincosamider og streptograminer (MLS) hos fødevareproducerende dyr i EU: resistensudvikling og betydningen heraf for menneskers og dyrs helbred (EMA/CVMP/SAGAM/741087/2009), er denne klasse af stoffer afgørende vigtig i veterinær- og humanmedicinen.
English: Pharmasin 250 mg/g Premix Tylosin phosphate
Danish: Pharmasin 250 mg/g OG Tylosin phosphate
English: Calves, Pigs, ChickensBroilers (not producing eggs for human consumption)
Danish: Kalve, svin, slagtekyllinger (som ikke producerer æg til konsum)
English: Oral solution Calves, chickens, pigs
Danish: Oral opløsning Kalve, kyllinger, svin
English: TYLOSINE BUVABLE NOE
Danish: TYLOSINE BUVABLE NOE Tylosin tartarate
English: PHARMACIN 25% premix
Danish: PHARMACIN 25% premix Tylosin
English: Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets)
Danish: Svin, kyllinger (slagtekyllinge r, avlskyllinger, æglæggere, erstatningshø nniker)
English: Delete, where applicable, the indication ‘Swine dysentery caused by Brachyspira hyodysenteriae'.
Danish: Hvor det er relevant, slettes indikationen ”svinedysenteri forårsaget af Brachyspira hyodysenteriae”.
English: Pigs, poultry (broilers, pullets, layers and turkeys), bovine (preruminants calves).
Danish: Svin, fjerkræ (slagtekyllinge r, hønniker, æglæggere, kalkuner), kvæg (ikkedrøvtyggende kalve)
English: TYLAN 100 mg/g premix
Danish: Pharmasin 100 mg/g Premix
English: Lithuania bela-pharm GmbH & Co. KG Lohner Str. 19
Danish: Litauen bela-pharm GmbH & Co.
English: Calves, Pigs, ChickensBroilers, Turkeys (not producing eggs for human consumption)
Danish: Kalve, svin, slagtekyllinger , kalkuner (ikke til anvendelse hos fugle, der producerer æg til konsum)
English: Valdlauči, Ķekavas pag.,LV
Danish: Valdlauči, Ķekavas pag.,LV-1076 Letland
English: PHARMASIN 10% premix
Danish: PHARMASIN 10% premix Tylosin
English: PHARMASIN 2%
Danish: PHARMASIN 2% Tylosin
English: Tylosintartrat 100%
Danish: Tylosintartrat 100% Kompaktat
English: Industrial Veterinaria, S.AINVESA
Danish: Industrial Veterinaria, S.A - INVESA Esmeralda 19
English: Delete, where applicable, any specific dosing recommendation related to swine dysentery caused by Brachyspira hyodysenteriae.
Danish: Hvor det er relevant, slettes eventuelle særlige doseringsanbefalinger for svinedysenteri forårsaget af Brachyspira hyodysenteriae.
English: Chickens (broilers, pullets, laying hens), turkeys, pigs, calves
Danish: Kyllinger (slagtekyllinge r, hønniker, æglæggere), kalkuner, svin, kalve
English: Pigs, poultry (chicken, turkey)
Danish: Svin, fjerkræ (kyllinger, kalkuner)
English: Cattle, pigs, poultry
Danish: Kvæg, svin, fjerkræ
English: Tilosina 20% liquida Neofarma Tylosin tartarate
Danish: Tilosina 20% liquida TreI Tylosin tartarate
English: Poultry Pig
Danish: Kyllinger Svin
English: Tylosintartrat 100% Kompaktat Tylosin tartarate
Danish: Tylosintartrat 100% Tylosin tartarate
English: Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae.
Danish: Hvor det er relevant, slettes enhver omtale af svinedysenteri forårsaget af Brachyspira hyodysenteriae.
English: Broilers, layer hens and future layer pullets turkeys, pigs and cattle (claves)
Danish: Slagtekyllinge r, æglæggere, kommende æglæggere, kalkuner, svin, kvæg (kalve)
English: Denmark Huvepharma NV Uitbreidingstraat 80
Danish: Danmark Huvepharma NV Uitbreidingstraat 80
English: Tylo-Suscit 100% Kompaktat Tylosin tartarate
Danish: Tylo-Suscit 100% Kompaktat
English: Pig, poultry
Danish: Svin, fjerkræ
English: Pigs, poultry
Danish: Svin, kyllinger
English: Pigs, chicken, turkeys
Danish: Svin, kyllinger, kalkuner
English: Chicken, turkey, pig, cattle
Danish: Kyllinger, kalkuner, svin, kvæg
English: Germany bela-pharm GmbH & Co. KG Lohner Str. 19
Danish: Tyskland bela-pharm GmbH & Co.
English: Belgium Huvepharma NV Uitbreidingstraat 80
Danish: En Belgien Huvepharma NV Uitbreidingstraat 80
English: Pigs, poultry and cattle
Danish: Svin, fjerkræ, kvæg
English: Cattle (calves), pig, chicken, turkey
Danish: Kvæg (kalve), svin, kyllinger, kalkuner
English: Germany Huvepharma NV Uitbreidingstraat 80
Danish: Tyskland Huvepharma NV Uitbreidingstraat 80
English: Chickens, Pigs
Danish: Kyllinger, svin
English: Calf, pig, poultry
Danish: Kalve, svin, fjerkræ
English: Gabrofam OOD
Danish: Bulgarien Gabrofam OOD 7002 Russe
English: Oral solution Calves, swine and broilers.
Danish: Oral opløsning Kalve, svin, slagtekyllinger
English: Porcine, chickens, calves
Danish: Svin, kyllinger, kalve
English: Calves, swine, chicken, turkeys
Danish: Svin, kalve, kyllinger, kalkuner
English: Animal species
Danish: Dyrearter, som lægemidlet er beregnet til
English: Swine, broilers
Danish: Svin, tamfugle
English: Poultry, swine, calves
Danish: Fjerkræ, svin, kalve
English: Pigs, chickens, turkeys, calves
Danish: Svin, kyllinger, kalkuner, kalve
English: Cattle, chickens, turkeys and pigs
Danish: Kvæg, kyllinger, kalkuner, svin
English: DELTAVIT
Danish: Dobrich
English: Poultry, pigs
Danish: Fjerkræ, svin
English: Cattle (calves), pig, chicken (broilers, future layers/breeder s), turkey
Danish: Kvæg (kalve) svin, kyllinger (slagtekyllinge r, kommende æglæggere/av lshøns), kalkuner
English: Cattle, pigs, chicken, turkey
Danish: Kvæg, svin, kyllinger, kalkuner
English: Calves, pigs, poultry
Danish: Kalve, svin, kyllinger
English: 7002 Russe
Danish: 1800-282 Lisboa
English: Calves, chickens, pigs
Danish: Kalve, kyllinger, svin
English: Swine, pigs, chickens, turkeys, calves for fattening
Danish: Svin, kyllinger, kalkuner, fedekalve
English: Lithuania Huvepharma NV Uitbreidingstraat 80
Danish: Rumænien Huvepharma NV Uitbreidingstraat 80
English: Chicken broilers, breeding pullets and laying hens, production pullets, turkey, pigs, calves
Danish: Slagtekyllinge r, hønekyllinger til avl, æglæggende høner, slagtehøns, kalkuner, svin, kalve
English: Chickens, turkeys, pigs
Danish: Kyllinger, kalkuner, svin
English: Pig, chicken (broilers, future layers/breeder s)
Danish: Svin, kyllinger (slagtekyllinger kommende æglæggere/ forældredyr)
English: PHARMASIN 100%
Danish: PHARMASIN 100% Tylosin
English: Chickens, turkeys, pigs and calves
Danish: Kyllinger, kalkuner, svin, kalve
English: Poultry, turkey, swine
Danish: Fjerkræ, kalkuner, svin
English: INDUSTRIAL VETERINARIA, S.A.
Danish: Spanien INDUSTRIAL VETERINARIA, S.A. Esmeralda 19.
English: Croatia
Danish: Litauen
English: Prahova
Danish: Prahova Rumænien
English: Pigs, chickens, turkeys and calves
Danish: Svin, slagtekyllinger , kalkuner, avlshøns og avlskalkuner
English: Calves, pigs, chicken, turkey
Danish: Kalve, svin, kyllinger, kalkuner
English: This summary was last updated in 12-2012.
Danish: Dette sammendrag blev sidst ajourført i 12-2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prometax on 4 December 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prometax den 4. december 1998.
English: The patches should not be cut into pieces.
Danish: Plastrene må ikke klippes i mindre stykker.
English: The patches can be worn during bathing and hot weather.
Danish: Plastrene kan beholdes på under badning og i varmt vejr.
English: The capsules should be swallowed whole.
Danish: Kapslerne skal synkes hele.
English: The full EPAR for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Prometax findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public rivastigmine
Danish: EPAR - sammendrag for offentligheden rivastigmin
English: This is a summary of the European public assessment report (EPAR) for Prometax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prometax.
English: The starting dose is 1.5 mg twice a day.
Danish: Startdosis er 1,5 mg to gange dagligt.
English: However, following a re-examination of this opinion, the Committee concluded that the medicine's modest effectiveness could also be of benefit to some of these patients.
Danish: Efter en ny gennemgang af denne udtalelse konkluderede udvalget imidlertid, at lægemidlets beskedne effekt samtidig kunne udgøre en gavnlig effekt for visse patienter.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Danish: Virkningen blev hovedsagelig bedømt på ændringen i symptomerne på to hovedområder: Dels kognitive funktioner (evnen til at tænke, lære og huske), dels overordnede funktioner (en kombination af flere områder bestående af generel funktionsevne, kognitive symptomer, adfærd og evne til at udføre daglige aktiviteter).
English: Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
Danish: Prometax-kapsler eller oral opløsning gives to gange dagligt sammen med morgen- og aftensmaden.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prometax.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Prometax.
English: The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Danish: Plastrene påføres ren, tør, ubehåret, sund hud på ryggen, overarmen eller brystkassen og skal skiftes hver 24 timer.
English: For more information about treatment with Prometax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prometax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Danish: De må ikke anbringes på irriteret eller rød hud, på låret eller maven eller på steder, hvor det vil gnide mod tætsiddende tøj.