FrancophonIA/ELRC3.0 huggingface dataset:
English: 34-41.4 kg Max
Danish: 34-41,4 kg Maks.
English: Similar results for the efficacy of guanfacine in the treatment of ADHD were established in 2 randomised, double-blind, placebo-controlled, fixed-dose (range of 1-4 mg/day) monotherapy trials in paediatric patients (children and adolescents 6-17 years old inclusive).
Danish: Lignende resultater for virkningen af guanfacin til behandling af ADHD blev klarlagt i 2 randomiserede, dobbeltblindede, placebokontrollerede studier med fastdosis monoterapi (interval fra 1-4 mg/dag) hos pædiatriske patienter (børn og unge i alderen 6 til og med 17 år).
English: • diarrhoea, abdominal discomfort or constipation
Danish: • diarré, mave- eller fordøjelsesbesvær
English: Intuniv 1 mg prolonged-release tablets Intuniv 2 mg prolonged-release tablets Intuniv 3 mg prolonged-release tablets Intuniv 4 mg prolonged-release tablets
Danish: Intuniv 1 mg depottabletter Intuniv 2 mg depottabletter Intuniv 3 mg depottabletter Intuniv 4 mg depottabletter
English: Study (SPD503-315) was a 41 week long term maintenance of efficacy study which included an open-label phase (up to 13 weeks) followed by double-blind, placebo-controlled, randomised-withdrawal phase (up to 26 weeks), conducted in paediatric patients (children and adolescents aged 6-17 years old inclusive) (n=526 in the open-label phase and n=315 in the double-blind randomised-withdrawal phase) to assess the efficacy, safety, and tolerability of once-daily dosing with guanfacine (children: 1-4 mg/day, adolescents:1-7 mg/day) in the treatment of ADHD.
Danish: Studie (SPD503-315) var et 41 ugers-studie af virkningen af vedligeholdelsebehandling, der inkluderede en open-label-fase (op til 13 uger) efterfulgt af en dobbeltblindet, placebokontrolleret, randomiseret tilbagetrækningsfase (op til 26 uger) udført hos pædiatriske patienter (børn og unge i alderen 6 til og med 17 år) (n=526 i open-label-fasen og n=315 i den dobbeltblinde, randomiserede tilbagetrækningsfase) for at vurdere guanfacins virkning, sikkerhed og tolerabilitet ved dosering en gang dagligt (børn: 1-4 mg/dag, voksne: 1-7 mg/dag) ved behandling af ADHD.
English: 58.5 kg and above
Danish: 58,5 kg og derover Maks.
English: Cardiovascular conditions.
Danish: Hjerte-kar-sygdomme.
English: In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than >60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
Danish: I fase II-III randomiserede, dobbeltblinde monoterapistudier var forhøjelser i QTc-intervalforlængelse, der overskred ændringer fra baseline med over >60 ms Fridericia-korrektion og Bazett-korrektion hhv. 0 (0,0 %) og 2 (0,3 %) hos placebopatienter og hhv. 1 (0,1 %) og 1 (0,1 %) hos Intuniv-patienter.
English: In addition a 15-week, double-blind, randomised, placebo-controlled, dose-optimisation study (SPD503-312) conducted in adolescents aged 13-17 years (n=314) to confirm the efficacy, safety, and tolerability of guanfacine (1-7 mg/day) in the treatment of ADHD.
Danish: Desuden blev der udført et 15-ugers, dobbeltblindet, randomiseret, placebokontrolleret dosisoptimeringsstudie (SPD503-312) hos unge i alderen 13-17 år (n=314) for at bekræfte guanfacins virkning, sikkerhed og tolerabilitet (1-7 mg/dag) til behandling af ADHD.
English: Guanfacine showed significantly greater improvement compared to placebo regardless of time (AM or PM) of administration (placebo-adjusted LS mean difference of -9.4 and -9.8 for AM and PM dosing, respectively, p<0.001).
Danish: Guanfacin viste signifikant større forbedring sammenlignet med placebo uanset administrationstidspunktet (før eller efter kl. 12) (placebojusteret mindste kvadraters gennemsnitlige forskel på -9,4 og -9,8 for dosering hhv. før eller efter kl. 12, p<0,001).
English: In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than 60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
Danish: I randomiserede, dobbeltblinde fase II-III-studier med monoterapi var der henholdsvise forhøjelser i QTc-intervalforlængelse, der overskred ændringer fra baseline over 60 ms Fridericia-korrektion og Bazett-korrektion 0 (0,0 %) og 2 (0,3 %) hos placebopatienter og 1 (0,1 %) og 1 (0,1 %) hos Intunivpatienter.
English: Prior to prescribing, it is necessary to conduct a baseline evaluation to identify patients at increased risk of somnolence and sedation, hypotension and bradycardia, QT-prolongation arrhythmia and weight increase/risk of obesity.
Danish: Før ordinering er det nødvendigt at udføre en baselineevaluering(evaluering af udgangspunktet) for at identificere patienter med en øget risiko for døsighed og sedation, hypotension og bradykardi, arytmi forårsaget af QT-forlængelse og vægtøgning/risiko for fedme.
English: Intuniv contains lactose.
Danish: Intuniv indeholder lactose.
English: Nervous system disorders Somnolence
Danish: Nervesystemet Døsighed
English: The impact of renal impairment on the pharmacokinetics of guanfacine in paediatric patients (children and adolescents 6-17 years old) was not assessed.
Danish: Påvirkningen af en nedsat nyrefunktion på guanfacins farmakokinetik hos pædiatriske patienter (børn og unge i alderen 6-17 år) er ikke vurderet.
English: • The 3 mg and 4 mg tablets also contain indigo carmine E 132 and yellow iron oxide E 172 What Intuniv looks like and contents of the pack
Danish: • Tabletterne med 3 mg og 4 mg indeholder også indigocarmin E132 og gul jernoxid E 172
English: • fits or convulsions
Danish: • kvalme eller opkastning
English: Carton
Danish: KARTON
English: Some of these side effects are more likely to occur at the start of treatment and may disappear as you continue with your treatment, if you experience any of these side effects contact your doctor straight away.
Danish: Nogle af disse bivirkninger opstår hyppigere i starten af behandlingen og kan forsvinde, når du fortsætter behandlingen.
English: 41.5-49.4 kg Max
Danish: 41,5-49,4 kg Maks.
English: The impact of hepatic impairment on the pharmacokinetics of guanfacine in paediatric patients (children and adolescents 6-17 years old) was not assessed.
Danish: Påvirkningen af en nedsat leverfunktion på guanfacins farmakokinetik hos pædiatriske patienter (børn og unge i alderen 6-17 år) er ikke vurderet.
English: • The other ingredients are hypromellose, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (Type A), microcrystalline cellulose, silica colloidal anhydrous, sodium laurilsulphate, polysorbate 80, fumaric acid, glyceryl dibehenate.
Danish: lactosemonohydrat, povidon, crospovidon (Type A), mikrokrystallinsk cellulose, silica, kolloid vandfri, natriumlaurilsulfat, polysorbat 80, fumarsyre, glyceroldibehenat.
English: Middle insomnia
Danish: Insomni midt om natten
English: 7.14mm round, white to off-white tablets debossed with ‘1MG' on one side and ‘503' on the other side.
Danish: 7,14 mm runde, hvide til off-white tabletter præget med '1MG' på den ene side og med '503' på den anden side.
English: Blisters
Danish: BLISTRE
English: Fluconazole, itraconazole, posaconazole Fungal infections.
Danish: Fluconazol, itraconazol, posaconazol
English: • feeling agitated
Danish: • en følelse af at være ophidset (agitation)
English: Blood pressure and heart rate increase upon discontinuation of Intuniv Blood pressure and pulse may increase following discontinuation of Intuniv.
Danish: Forhøjet blodtryk og forhøjet hjertefrekvens efter seponering af Intuniv Efter seponering af Intuniv kan blodtrykket og pulsen stige.
English: If you are worried, speak to your doctor.
Danish: Kontakt lægen, hvis du er bekymret.
English: Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
Danish: Hver 3 mg tablet indeholder 37,81 mg lactose (som monohydrat).
English: o somnolence and sedation o hypotension o bradycardia
Danish: • Tegn og symptomer på: o døsighed og sedation o hypotension o bradykardi
English: Blood pressure and heart rate increase upon discontinuation Blood pressure and pulse may increase following discontinuation of Intuniv.
Danish: Forhøjet blodtryk og forhøjet hjertefrekvens efter seponering Efter seponering af Intuniv kan blodtrykket og pulsen stige.
English: CYP3A4 and CYP3A5 inhibitors
Danish: CYP3A4- og CYP3A5-hæmmere
English: Moderate CYP3A4/5 inhibitors
Danish: Moderate CYP3A4/5hæmmere
English: 7 prolonged-release tablets 28 prolonged-release tablets
Danish: 7 depottabletter 28 depottabletter
English: Intuniv 3 mg tablet 7.94mm round, green tablets debossed with ‘3MG' on one side and ‘503' on the other side.
Danish: Intuniv 3 mg tablet 7,94 mm runde, grønne tabletter præget med '3MG' på den ene side og med '503' på den anden side.
English: 7 prolonged-release tablets 28 prolonged-release tablets 84 prolonged-release tablets
Danish: 7 depottabletter 28 depottabletter 84 depottabletter
English: • reduced heart rate
Danish: • nedsat puls
English: • feeling sleepy (somnolence)
Danish: • følelse af at være søvnig (døsighed)
English: 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustments (see section 4.4).
Danish: Det anbefales, at en klinisk bedømmelse skal udføres i løbet af denne periode med efterfølgende overvågning hver 6. måned og hyppigere overvågning efter dosisjusteringer (se pkt.
English: Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
Danish: Hver 4 mg tablet indeholder 50,42 mg lactose (som monohydrat).
English: The effects of guanfacine in the treatment of ADHD has been examined in 5 controlled studies in children and adolescents (6 to 17 years), 3 short-term controlled trials in children and adolescents aged 6 to 17 years, 1 short-term controlled study in adolescents aged 13 to 17 years, and 1 randomised withdrawal trial in children and adolescents aged 6-17 years, all of whom met the DSM-IV-TR criteria for ADHD.
Danish: Virkningen af guanfacin ved behandling af ADHD er blevet undersøgt i 5 kontrollerede studier af børn og unge (i alderen 6-17 år), 3 kortvarige kontrollerede studier af børn og unge i alderen 6-17 år,
English: 28 prolonged-release tablets 84 prolonged-release tablets
Danish: 28 depottabletter 84 depottabletter
English: 12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG' on one side and ‘503' on the other side.
Danish: 12,34 mm x 6,10 mm aflange, grønne tabletter præget med '4MG' på den ene side og med '503' på den anden side.
English: Dose= 5 mg
Danish: dosis=5 mg
English: Other CYP3A4/5 inhibitors may have a comparable effect, see table 3 for a list of examples of moderate and strong CYP3A4/5 inhibitors, this list is not definitive.
Danish: Se tabel 3 for en liste med eksempler på moderate og kraftige CYP3A4/5-hæmmere.
English: Renal and urinary disorders Enuresis
Danish: Nyrer og urinveje Enurese
English: Intuniv 1 mg pack sizes: 7 or 28 tablets.
Danish: Intuniv 1 mg pakningsstørrelser: 7 eller 28 tabletter.
English: • wetting yourself (enuresis)
Danish: • ufrivillig vandladning (enurese)
English: Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
Danish: Hver 2 mg tablet indeholder 44,82 mg lactose (som monohydrat).
English: 12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG' on one side and “503” on the other side.
Danish: 12,34 mm x 6,10 mm aflange, hvide til off-white tabletter præget med '2MG' på den ene side og med '503' på den anden side.
English: It is therefore recommended that patients will be closely monitored weekly during dose titration and stabilisation (see section 4.2), and every 3 months during the first year, taking into consideration clinical judgement.
Danish: Det anbefales derfor, at patienterne overvåges nøje ugentligt i løbet af dosistitrering og -stabilisering (se pkt.
English: Dose= 7 mg
Danish: dosis=7 mg
English: Dose= 6 mg
Danish: dosis=6 mg
English: What Intuniv contains
Danish: Intuniv indeholder:
English: Dose= 4 mg
Danish: dosis=4 mg
English: How to take Intuniv
Danish: Sådan skal du tage Intuniv
English: Sinus arrhythmia
Danish: Sinus arytmi
English: Other CYP3A4 inducers may have a comparable effect, see table 3 for a list of examples of CYP3A4/5 inducers, this list is not definitive.
Danish: Se tabel 3 for en liste med eksempler på CYP3A4/5-inducere.
English: Caution should be used when Intuniv is administered to patients taking ketoconazole and other moderate and strong CYP3A4/5 inhibitors, a decrease in the dose of Intuniv within the recommended dose range is proposed (see section 4.2).
Danish: Der bør udvises forsigtighed, når Intuniv administreres til patienter, der tager ketoconazol og andre moderate og kraftige CYP3A4/5-hæmmere.
English: What Intuniv is and what it is used for What you need to know before you take Intuniv How to take Intuniv
Danish: Det skal du vide, før du begynder at tage Intuniv Sådan skal du tage Intuniv Bivirkninger
English: Intuniv 2 mg pack sizes: 7, 28 or 84 tablets.
Danish: Intuniv 2 mg pakningsstørrelser: 7, 28 eller 84 tabletter.
English: Incidence Category
Danish: Størrelse af virkning
English: • educational therapy
Danish: • pædagogisk behandling
English: Very rare: may affect up to 1 in 10,000 people
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer):
English: Lisdexamfetamine dimesylate
Danish: Lisdexamfetamindimesylat
English: There was a substantial increase in the rate and extent of guanfacine exposure when administered with ketoconazole; the guanfacine peak plasma concentrations (Cmax) and exposure (AUC) increased 2- and 3-fold, respectively.
Danish: Den maksimale koncentration af guanfacin (Cmax) og eksponeringen (AUC) var hhv. 2 og 3 gange forhøjet.
English: Treatment groups
Danish: Behandlin gs-grupper
English: • The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on one side and 503 on the other side.
Danish: • 1 mg depottabletter er runde og hvide, hårde tabletter, præget med 1MG på den ene side og med 503 på den anden side.
English: EU/1/15/1040/003 7 prolonged-release tablets EU/1/15/1040/004 28 prolonged-release tablets EU/1/15/1040/005 84 prolonged-release tablets
Danish: EU/1/15/1040/003 7 depottabletter EU/1/15/1040/004 28 depottabletter EU/1/15/1040/005 84 depottabletter
English: Intuniv 4 mg pack sizes: 28 or 84 tablets.
Danish: Intuniv 4 mg pakningsstørrelser: 28 eller 84 tabletter.
English: • The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one side and 503 on the other side.
Danish: • 2 mg depottabletter er ovale og hvide, hårde tabletter, præget med 2MG på den ene side og med 503 på den anden side.
English: Intuniv 3 mg pack sizes: 28 or 84 tablets.
Danish: Intuniv 3 mg pakningsstørrelser: 28 eller 84 tabletter.
English: • The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on one side and 503 on the other side.
Danish: • 3 mg depottabletter er runde og grønne, hårde tabletter, præget med 3MG på den ene side og med 503 på den anden side.
English: • Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine
Danish: • Hver 1 mg tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin
English: • The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side.
Danish: • 4 mg depottabletter er ovale og grønne, hårde tabletter, præget med 4MG på den ene side og med 503 på den anden side.
English: EU/1/15/1040/001 7 prolonged-release tablets EU/1/15/1040/002 28 prolonged-release tablets
Danish: EU/1/15/1040/001 7 depottabletter EU/1/15/1040/002 28 depottabletter
English: Intuniv 1 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Danish: Intuniv 1 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin.
English: • Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine
Danish: • Hver 4 mg tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin
English: EU/1/15/1040/008 28 prolonged-release tablets EU/1/15/1040/009 84 prolonged-release tablets
Danish: EU/1/15/1040/008 28 depottabletter EU/1/15/1040/009 84 depottabletter
English: • Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine
Danish: • Hver 2 mg tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin
English: Intuniv 4 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Danish: Intuniv 4 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin.
English: Intuniv 2 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Danish: Intuniv 2 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin.
English: Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Danish: Hver tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin.
English: • Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine
Danish: • Hver 3 mg tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin
English: Intuniv 2 mg prolonged-release tablets Guanfacine
Danish: Intuniv 2 mg depottabletter Guanfacin
English: Intuniv 3 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Danish: Intuniv 3 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor or pharmacist before taking this medicine.
Danish: Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke kan tåle eller fordøje visse sukkerarter.
English: EU/1/15/1040/006 28 prolonged-release tablets EU/1/15/1040/007 84 prolonged-release tablets
Danish: EU/1/15/1040/006 28 depottabletter EU/1/15/1040/007 84 depottabletter
English: Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Danish: Hver tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin.
English: Intuniv 1 mg prolonged-release tablets Guanfacine
Danish: Intuniv 1 mg depottabletter Guanfacin
English: Intuniv 4 mg prolonged-release tablets Guanfacine
Danish: Intuniv 4 mg depottabletter Guanfacin
English: Heart rate decreased
Danish: Nedsat puls
English: • feeling weak (asthenia)
Danish: • svaghedsfølelse (asteni)
English: Intuniv 3 mg prolonged-release tablets Guanfacine
Danish: Intuniv 3 mg depottabletter Guanfacin
English: General disorders Fatigue
Danish: Almene symptomer Træthed
English: Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Danish: Hver tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin.
English: Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Danish: Hver tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin.
English: Intuniv 3 mg prolonged-release tablets
Danish: Intuniv 3 mg depottabletter
English: If you take more Intuniv than you should
Danish: Hvis du har taget for meget Intuniv
English: • social therapy
Danish: • social behandling
English: Intuniv 4 mg prolonged-release tablets
Danish: Intuniv 4 mg depottabletter
English: Intuniv 2 mg prolonged-release tablets
Danish: Intuniv 2 mg depottabletter
English: Excipients
Danish: Respondenter
English: Affect lability
Danish: Affektlabilitet
English: Intuniv 1 mg prolonged-release tablets
Danish: Intuniv 1 mg depottabletter
English: Pallor
Danish: Perikon
English: • Summary of Product Characteristics (SmPC) and Package Leaflet
Danish: • Produktresumé og indlægsseddel
English: What is colistin?
Danish: Hvad er colistin?
English: 14 July 2016
Danish: 14. juli 2016
English: This advice critically reviewed information on
Danish: Disse anvisninger gennemgik kritiske oplysninger om
English: The European Commission issued a decision on 14 July 2016.
Danish: Europa-Kommissionen traf en afgørelse den 14. juli 2016.
English: Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Danish: Colistin anvendes til behandling og forebyggelse af sygdomme, der skyldes følsomme bakterier (f.eks. Escherichia coli) hos svin, fjerkræ, kaniner, kvæg, får og geder.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/111)
English: 2 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
Danish: 2 om at begrænse indikationerne, måldyrearterne og behandlingsvarigheden for de pågældende produkter og tilføje advarsler om forsvarlig brug i produktinformationen.
English: the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health and the possible impact on human and animal health.
Danish: anvendelsen af colistin hos fødevareproducerende dyr i EU, dets effekt på udviklingen af resistens over for denne kategori af antimikrobielle stoffer hos bakteriearter, der er vigtige for menneskers og dyrs sundhed, og den mulige indvirkning heraf på menneskers og dyrs sundhed.
English: Colistin belongs to the polymyxin group of antibiotics.
Danish: Colistin tilhører den gruppe antibiotika, der kaldes polymyxiner.
English: The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Danish: CVMP blev anmodet om at gennemgå markedsføringstilladelserne og de tilgængelige data for at sikre ansvarlig anvendelse af stoffet med henblik på at beskytte dyrs sundhed og begrænse muligheden for en fremtidig risiko for folkesundheden.
English: These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab).
Danish: Der er tale om veterinærlægemidler, der indeholder colistin kombineret med 14 forskellige antimikrobielle stoffer fra forskellige klasser, f.eks. β-laktamer, tetracykliner, makrolider, sulfonamider og trimethoprim (se bilag I under fanebladet "All documents").
English: Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States.
Danish: Colistin kombineret med andre antimikrobielle stoffer fås til gruppebehandling af gastrointestinale og respiratoriske infektioner hos fødevareproducerende dyr i forskellige EU-medlemsstater.
English: Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally EMA/461505/2016
Danish: Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration EMA/461505/2016
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Danish: EMA's Udvalg for Lægemidler til Dyr (CVMP) har konkluderet, at det generelle benefit/risk-forhold for de nævnte veterinærlægemidler er negativt, dels som følge af den manglende kliniske relevans, dels på baggrund af, at overeksponering for colistin kan udgøre en potentiel risiko for dyrs og menneskers sundhed ved at fremskynde forekomsten af resistens mod colistin.