FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder has provided evidence that the baseline PK of doxycycline, when delivered orally to pigs at a dose of 12.5 mg/kg body weight will provide plasma levels of 0.71 - 1.14 µg/ml (Pijpers et al (1991) 1.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt bevis for, at baseline farmakokinetik for doxycyclin indgivet oralt til svin i en dosis på 12,5 mg/kg kropsvægt vil føre til plasmaniveauer på 0,71 - 1,14 µg/ml (Pijpers et al (1991)1.
English: Doxycycline is a broad-spectrum antibiotic, active against a large number of Gram-positive and Gramnegative, aerobe and anaerobe micro-organisms, Mycoplasmata, Chlamydiae and Rickettsia.
Danish: Doxycyclin er et bredspektret antibiotikum, der er virksomt over for et stort antal gram-positive og gramnegative, aerobe og anaerobe mikroorganismer, mycoplasma, Clamydia og Rickettsia.
English: Further the Marketing Authorisation Holder has also provided evidence (Bousquet et al. 1998)2 that doxycycline will concentrate in nasal secretions and if fed at dose regimens between 11.8 -13.3 mg/kg body weight for 1 hour per day concentrations of between 0.7 and 1 µg/ml are achieved in the lung and nasal concentrations of 1.7 +/- 0.4 µg/ml are reached.
Danish: Desuden har indehaveren af markedsføringstilladelsen også fremlagt bevis (Bousquet et al. 1998)2for, at doxycyclin vil blive koncentreret i sekreter fra næsen, og at hvis det indgives ved doseringer mellem 11,8 og 13,3 mg/kg kropsvægt i 1 time om dagen, opnås der koncentrationer på mellem 0,7 og 1 µg/ml i lungerne, og der opnås nasale koncentrationer på 1,7 +/- 0,4 µg/ml.
English: No data have been provided for chickens, however the Marketing Authorisation Holder submitted in support of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Danish: Der er ikke blevet fremsendt data for kyllinger, men indehaveren af markedsføringstilladelsen indsendte som støtte den nyligt indbragte sag i henhold til artikel 35 om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ og beregnet til indgivelse via drikkevandet (EMEA/V/A/047).
English: Do not combine with antibiotics that are bacteriocidal e.g. penicillins or cephalosporins.
Danish: Må ikke kombineres med bakteriocide antibiotika f.eks. penicilliner eller cefalosporiner.
English: Doxycycline belongs to the group of the tetracycline antibiotics.
Danish: Doxycyclin tilhører gruppen af tetracyclinantibiotika.
English: Carton box for the 10x100 grams Alufoil sachets with label for 100 gram sachets and leaflet
Danish: Kartonæske til 10 x 100 gram alufoliebreve med etiket til breve med 100 gram og indlægsseddel
English: It exerts its action by inhibiting the protein synthesis of the bacterial cell.
Danish: Det virker ved at hæmme proteinsyntesen i bakteriecellen.
English: If you know you are allergic to the tetracycline class of antibiotics, special care should be taken when handling this product or the medicated solution.
Danish: I tilfælde af allergi over for antibiotika af tetracyclin-klassen skal der udvises særlig forsigtighed under håndteringen af dette produkt og den medicinerede opløsning.
English: OTHER INFORMATION Pack sizes: 100g, 10x 100g, 250g, 500g and 1 kg Not all pack sizes may be marketed.
Danish: ANDRE OPLYSNINGER Pakningsstørrelser: 100 g, 10 x 100 g, 250 g, 500 g og 1 kg Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Sachets of 100g, 250g, 500g and 1 kg and 10x 100g in a carton box.
Danish: Poser med 100 g, 250 g, 500 g og 1 kg og 10 x 100 g i æske af karton.
English: Data had previously been submitted as part of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Danish: Der var tidligere blevet fremsendt data som en del af den nyligt indbragte sag i henhold til artikel 35 om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ, og beregnet til indgivelse via drikkevandet (EMEA/V/A/047).
English: Following administration of doxycycline hyclate at an actual dose of 21 mg/kg body weight to chickens mean plasma concentrations above 1 µg/ml were reached within 6 hours and lasted for 6 hours after cessation of medication.
Danish: Efter administration af doxycyclinhyclat til kyllinger med en faktisk dosis på 21 mg/kg kropsvægt opnåedes middel plasmakoncentrationer over 1 µg/ml i løbet af 6 timer, og som varede i 6 timer efter seponering af medicineringen.
English: When pigs are administered 12.5 mg doxycycline hyclate/kg bw/day for 8 days; meat withdrawal periods of 4 days will ensure consumer safety.
Danish: Når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i 8 dage, vil en tilbageholdelsestid på 4 dage garantere forbrugersikkerheden.
English: Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Danish: Kyllinger: Benyttes i flokke med klinisk sygdom til reduktion af mortalitet, morbiditet og kliniske symptomer samt til reduktion af læsioner på grund af pasteurellose forårsaget af Pasteurella multocida eller til at reducere morbiditet og læsioner i tilfælde af luftvejsinfektioner forårsaget af Ornithobacterium rhinotracheale (ORT).
English: PACKAGE SIZE 100 gram
Danish: PAKNINGSSTØRRELSE 100 gram
English: Following administration of doxycycline hyclate at an actual dose of 10 mg/kg body weight steady state plasma concentrations ranged from 0.75 to 0.93 µg/g between 12 and 96 hours after start of medication.
Danish: Efter administration af doxycyclinhyclat med en faktisk dosis på 10 mg/kg kropsvægt lå steady state-koncentrationen i området fra 0,75 til 0,93 µg/g mellem 12 og 96 timer efter påbegyndelse af medicineringen.
English: Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa.
Danish: Tetracycliner har et bredt aktivitetsspektrum, som hæmmer Gram-positive og Gram-negative bakterier, mycoplasmer, chlamydiae, rickettsier og visse protozoer.
English: Special precautions for use
Danish: Særlige forsigtighedsregler vedrørende brugen
English: 500 mg corresponding to 433 mg doxycycline 433 mg corresponding to 500 mg doxycycline hyclate
Danish: 500 mg svarende til 433 mg doxycyclin 433 mg corresponding to 500 mg doxycycline hyclate
English: Doxycycline is a semi-synthetic tetracycline antibiotic.
Danish: Doxycyclin er et halvsyntetisk antibiotikum af tetracyclintypen.
English: Four resistance mechanisms acquired by microorganisms against tetracyclines in general have been reported: Decreased accumulation of tetracyclines (decreased permeability of the bacterial cell wall and active efflux), protein protection of the bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations (preventing the tetracycline binding to ribosome).
Danish: Nedsat akkumulering af tetracycliner (nedsat permeabilitet af bakteriens cellevæg og aktivt effluks), proteinbeskyttelse af det bakterielle ribosom, enzymatisk inaktivering af antibiotikummets og rRNA-mutationer (som forhindrer tetracyclin i at binde sig til ribosomet).
English: Animal species
Danish: Lægemiddel-form Dyrearter
English: UK
Danish: Det Forenede Kongerige
English: Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administered together with antacids, kaolin and iron preparations.
Danish: Optagelsen af doxycyclin kan reduceres ved tilstedeværelse af store mængder calcium, jern, magnesium eller aluminium i foderet.
English: 4.4 Special warning for each target species.
Danish: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: Hungary Eurovet Animal Health B.V., P.O. 179,
Danish: Eurovet Animal Health B.V., P.O. 179,
English: • Chickens (broiler, pullet, breeder): 10 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by P. multocida and 20 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by
Danish: • Kyllinger (slagtekyllinger, unghøns, avlshøns):10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 3 til 4 dage til behandling af infektioner forårsaget af P. multocida, og 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 3 til 4 dage til behandling af infektioner forårsaget af O.
English: - Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days.
Danish: - Kød og indvolde: 12 dage efter en dosering på 20 mg/kg kropsvægt i 4 dage.
English: Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially susceptibility of A. pleuropneumoniae and O. rhinotracheale may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr På grund af bakteriernes forventelige varierende følsomhed (tidsmæssig, geografisk) over for doxycyclin, hvor særligt A. pleuropneumoniae og O. rhinotracheale kan udvise forskelle i følsomheden fra et land til et andet og endog fra en gård til en anden, anbefales det at udføre bakteriologisk prøvetagning og følsomhedstestning.
English: (1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40
Danish: 29 , 475-485 3 Bousquet E., Morvan H., AitkenI., Morgan J.H.(1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40
English: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 consecutive days.
Danish: 12,5 mg doxycyclinhyclat (25 mg produkt) per kg kropsvægt per dag i 4 på hinanden følgende dage.
English: F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 51: 374 - 379
Danish: F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Anti-microbial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 5 De Jong et al.: A pan-European survey of antimicrobial susceptibility towards human-use antimicrobial drugs among zoonotic and commensal bacteria isolated from healthy food producing animals.
English: PHARMACEUTICAL FORM Yellow powder for use in drinking water.
Danish: LÆGEMIDDELFORM Gult pulver til brug i drikkevand.
English: PHARMACEUTICAL FORM Yellow crystalline powder for use in drinking water.
Danish: LÆGEMIDDELFORM Gult, krystallinsk pulver til brug i drikkevand.
English: 6.4 Storage precautions
Danish: 6.4 Særlige opbevaringsforhold
English: Pigs and chickens (broiler, pullet, breeder).
Danish: Svin og kyllinger (slagtekyllinger, unghøns, avlshøns).
English: The chicken meat residue depletion data for both dosing regimens (10 mg doxycycline hyclate per kg body weight per day for 4 days and 20 mg doxycycline hyclate per kg body weight per day for 4 days) were submitted.
Danish: Restkoncentrationsdataene for kyllingekød for begge doseringer (10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage og 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage) blev fremsendt.
English: Chickens: - Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days.
Danish: Kyllinger: - Kød og indvolde: 3 dage efter en dosering på 10 mg/kg kropsvægt i 4 dage.
English: Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline.
Danish: Svin: Til behandling af de kliniske symptomer i forbindelse med luftvejsinfektioner hos svin forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida og Mycoplasma hyopneumoniae, der er følsomme over for doxycyclin.
English: TARGET SPECIES Pigs and chickens (broiler, pullet, breeder).
Danish: DYREARTER Svin og kyllinger (slagtekyllinger, unghøns, avlshøns).
English: • Pigs: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4
Danish: • Svin:12,5 mg doxycyclinhyclat (25 mg lægemiddel) pr. kg kropsvægt pr. dag i 4 på hinanden følgende dage.
English: If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician.
Danish: Hvis der opstår symptomer som f.eks. hududslæt efter eksponering, skal der straks søges lægehjælp.
English: Doxycycline hyclate France: Doxycycline Excipients
Danish: Doxycyclinhyclat FR: Doxycycline Hjælpestoffer:
English: A chicken meat withdrawal period of 3 days when chickens are treated with 10 mg doxycycline hyclate/kg bw/day for 4 days; and a meat withdrawal period of 12 days when the chicken are treated with 20 mg doxycycline hyclate/kg bw/day for 4 days can be accepted.
Danish: En tilbageholdelsestid for kyllingekød på 3 dage, når kyllingerne behandles med 10 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage, og en tilbageholdelsestid på 12 dage, når kyllingerne behandles med 20 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage kan accepteres.
English: MARKETING AUTHORISATION NUMBER To be completed nationally
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER Udfyldes nationalt
English: PACKAGE SIZE 10x100 gram
Danish: PAKNINGSSTØRRELSE 10 x 100 gram
English: 10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and
Danish: 10 mg doxycyclinhyclat (20 mg produkt) per kg kropsvægt per dag i 3-4 på hinanden følgende dage i tilfælde af infektion forårsaget af P. multocida og
English: In addition a chicken meat withdrawal period of 12 days following a dose rate of 20 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
Danish: Desuden blev en tilbageholdelsestid for kyllingekød på 12 dage efter en dosis på 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage anset for at være acceptabel.
English: 20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale.
Danish: 20 mg doxycyclinhyclat (40 mg produkt) per kg kropsvægt per dag i 3-4 på hinanden følgende dage i tilfælde af infektion forårsaget af O. rhinotracheale.
English: Doxycycline is primarily excreted with the faeces.
Danish: Doxycyclin udskilles primært med fæces.
English: A chicken meat withdrawal period of 3 days following a dose rate of 10 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
Danish: En tilbageholdelsestid for kyllingekød på 3 dage efter en dosis på 10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage blev anset for at være acceptabel.
English: Because doxycycline is highly lipid soluble, it has a good tissue penetration.
Danish: På grund af dets høje lipidopløselighed udviser doxycyclin en god vævspenetration.
English: Powder for use in drinking water pigs, chickens (non-egg laying)
Danish: Svin, Kyllinger (non-egg laying)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Udfyldes nationalt
English: Chickens
Danish: Gnmsnt.
English: • Chickens (broiler, pullet, breeder): Where clinical disease is present in the flock, to reduce mortality, morbidity and clinical signs and to reduce lesions due to Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by O. rhinotracheale.
Danish: • Kyllinger (slagtekyllinger, unghøns, avlshøns): Når der er klinisk sygdom i flokken, for at nedbringe dødelighed, morbiditet og kliniske tegn, og for at nedbringe læsioner på grund af
English: In pig pathogens resistance against doxycycline may also vary; especially susceptibility figures of A. pleuropneumoniae may differ from country to country and even farm to farm.
Danish: Særligt kan A. pleuropneumoniae udvise forskelle i følsomheden fra et land til et andet og endog fra en gård til en anden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDLÆGSSEDDEL
English: NL-5531 AE Bladel,
Danish: Handelsweg 25, NL-5531 AE Bladel, The Netherlands
English: LEAFLET
Danish: Vinsyre
English: Evaluation of the Benefit-risk balance
Danish: Vurdering af benefit/risk-forholdet
English: • Target species;
Danish: • Dosering;
English: Soludox, 500 mg/g, Water Soluble Powder for Pigs
Danish: Soludox, 500 mg/g, Water Soluble Powder for Svin
English: Applicant/
Danish: Til brugeren
English: Benefit Risk assessment
Danish: Benefit/risk-vurdering
English: Pigs Chickens
Danish: Svin Kyllinger
English: The pig meat residue depletion data was made available and supported a meat withdrawal period of 4 days when pigs are administered 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Danish: Restkoncentrationsdataene for svinekød blev indsendt, og disse understøttede en tilbageholdelsestid på 4 dage, når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i op til 8 dage.
English: Residue depletion data in chickens support a meat withdrawal period of 3 days when chickens are administered at 10 mg doxycycline hyclate/kg body weight/day for 4 days.
Danish: Restkoncentrationsdata for kyllinger understøtter en tilbageholdelsestid på 3 dage, når kyllinger indgives 10 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage.
English: Residue depletion data in chickens support a meat withdrawal period of 12 days when chickens are administered at 20 mg doxycycline hyclate/kg body weight/day for 4 days.
Danish: Restkoncentrationsdata hos kyllinger understøtter en tilbageholdelsestid på 12 dage, når kyllinger indgives 20 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage.
English: MARKETING AUTHORISATION HOLDER To be completed nationally
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt
English: Residue depletion data in pigs support a meat withdrawal period of 4 days when pigs are administered at 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Danish: Restkoncentrationsdata hos svin understøtter en tilbageholdelsestid på 4 dage, når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i op til 8 dage.
English: Summary of product characteristics, labelling and package leaflet
Danish: Bilag III Produktresumé, etikettering, indlægsseddel
English: Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179 5530 AD Bladel The Netherlands
Danish: Handelsveg 25 - PO Box 179 5530 AD Bladel The Netherlands
English: France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline
Danish: FR: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline
English: France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline.
Danish: FR: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline.
English: Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel The Netherlands
Danish: Handelsveg 25 - PO Box 179, 5530 AD Bladel The Netherlands
English: Lithuania Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel
Danish: Handelsveg 25 - PO Box 179, 5530 AD Bladel
English: DATE ON WHICH THE TEXT WAS LAST APPROVED To be completed nationally
Danish: DATO FOR SENESTE GODKENDELSE AF TEKSTEN Skal udfyldes
English: Soludox 500 mg/g powder for use in drinking water for chickens
Danish: Soludox 500 mg/g powder for use in drinking water for Kyllinger
English: Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate
Danish: Doxycyclinhyclat 500 mg, svarende til 433 mg doxycyclin.
English: Soludox 500 mg/g powder for use in drinking water for pigs
Danish: Soludox 500 mg/g powder for use in drinking water for Svin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only)
Danish: Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only)
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens Doxycycline hyclate.
Danish: Soludox 500 mg/g pulver til brug i drikkevand til svin og kyllinger.
English: Poland Eurovet Animal Health B.V., Handelsweg 25,
Danish: Eurovet Animal Health B.V.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER
English: • Amounts to be administered;
Danish: • Dyrearter, som lægemidlet er beregnet til;
English: Erbitux has been authorised since June 2004.
Danish: Erbitux har været godkendt siden juni 2004.
English: It is already used to treat the following types of cancer:
Danish: Det anvendes allerede til behandling af følgende kræftformer:
English: These ‘subgroup analyses' attempted to identify a group of patients that would benefit from treatment.
Danish: I disse ‘undergruppeanalyser' blev det tilstræbt at identificere en gruppe af patienter, som ville drage fordel af behandlingen.
English: As a result, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Danish: Som følge heraf kan tumorcellerne ikke længere modtage de signaler, der får dem til at vokse, udvikle sig og spredes.
English: ‘Metastatic' means that the cancer has spread to other parts of the body;
Danish: ‘Metastatisk' betyder, at kræften har spredt sig til andre dele af kroppen
English: The CHMP was also concerned over discrepancies in the studies' findings between the two main measures of effectiveness.
Danish: CHMP var også betænkelig ved uoverensstemmelserne i undersøgelsesresultaterne mellem de to vigtigste målestokke for effekt.
English: The company presented the results of two main studies involving a total of 1,801 adults with advanced, metastatic or recurrent non-small cell lung cancer who had not been treated before.
Danish: Virksomheden fremlagde resultaterne af to hovedundersøgelser, som omfattede i alt 1 801 voksne med fremskreden, metastatisk eller recidiverende ikke-småcellet lungekræft, der ikke tidligere var blevet behandlet.
English: In November 2009, following the re-examination, the CHMP added a further concern over the ways in which the studies' results were analysed after they can been completed.
Danish: I november 2009 efter revurderingen tilføjede CHMP en yderligere betænkelighed ved de måder, hvorpå resultaterne af undersøgelserne var blevet analyseret, efter at de var afsluttet.
English: The main measures of effectiveness were how long the patientssurvived and how long they lived without their cancer getting worse.
Danish: Det primære effektmål var, hvor længe patienterne overlevede, og hvor længe de levede, uden at kræften forværredes.
English: Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Erbitux cetuximab
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Erbitux cetuximab
English: There are no consequences on the use of Erbitux in its authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser for anvendelse af Erbitux til de godkendte indikationer, for hvilke benefit/risk-forholdet forbliver uændret.