FrancophonIA/ELRC3.0 huggingface dataset:
English: Advice for Veterinarian
Danish: Vejledning til dyrlægen
English: A colourless to pale yellow solution.
Danish: Farveløs til svagt gul opløsning.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: Shelf life after first opening the container: 3 months
Danish: Opbevaringstid efter første åbning af beholderen: 3 måneder.
English: If the bodyweight loss since previous monthly weighing has been <3% bodyweight per month, the dose should be increased without adjusting for the dog's current bodyweight.
Danish: Hvis vægttabet siden foregående måned er <3 % af legemsvægten pr. måned, skal dosis øges uden at korrigere for hundens aktuelle legemsvægt.
English: 20 ml packed with 2 dosing devices of 1 ml 50 ml packed with 2 dosing devices of 3 ml 150 ml packed with 2 dosing devices of 10 ml
Danish: 20 ml pakket med 2 sprøjter à 1 ml 50 ml pakket med 2 sprøjter à 3 ml 150 ml pakket med 2 sprøjter à 10 ml
English: Dose 1 = Starting dose = Initial BW x
Danish: Dosis 1 = Startdosis = begyndelsesvægt x
English: In subsequent required conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times the volume administered in the previous month) up to a maximum dose of the veterinary medicinal product of 0.2 ml/kg current bodyweight.
Danish: Ved efterfølgende øgninger, skal dosis forøges med 50 % (dosisvolumen forøges til 1,5 gang doseringen, som blev givet i den foregående måned) op til det maksimale dosisvolumen af veterinærlægemidlet på 0,2 ml/kg aktuel legemsvægt.
English: Following these initial 4 weeks of therapy, dose adjustments are made monthly according to effect as described in section 9.
Danish: Efter 4 ugers behandling foretages dosisjusteringer hver måned i forhold til effekten beskrevet i afsnit 9.
English: Dose 6 = Dose 5 x 1.5
Danish: Dosis 6 = Dosis 5 x 1,5
English: After two weeks of therapy, the initial dose (number of ml administered) should be increased by 100% (doubled).
Danish: Efter to ugers behandling skal initialdosis (antal ml administreret) øges med 100 % (fordobles).
English: On rare occasions, reports of change of behaviour such as polyphagia, or very rarely reports of aggression associated with food and feeding have been observed in Slentrol-treated dogs.
Danish: Hos hunde behandlet med Slentrol er der i sjældne tilfælde blevet rapporteret adfærdsændringer såsom polyfagi, og i meget sjældne tilfælde aggression associeret med foder og fodring.
English: Dose 5 = Dose 4 x 1.5
Danish: Dosis 5 = Dosis 4 x 1,5
English: In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
Danish: I kliniske forsøg tog de behandlede dyr hurtigt på i vægt efter behandlingens afslutning, når foderet ikke blev reduceret.
English: MTP (Microsomal Trigylyceride transfer Protein) inhibitors as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental toxicity.
Danish: Gruppen af MTP (Microsomal Triglyceride transfer Protein)-hæmmere har potentiale til at forstyrre udviklingen af blommesækken, og laboratorieundersøgelser i rotter og kaniner og har vist tegn på at de er embryoletale, teratogene og reproduktionstoksiske.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: Dogs with evidence of liver dysfunction should not be treated with the veterinary medicinal product.
Danish: Dyr med symptomer på leverdysfunktion bør ikke behandles med veterinærlægemidlet.
English: Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be
Danish: Hunde, der får andre behandlinger sideløbende med veterinærlægemidlet, bør holdes under opsyn for interaktioner.
English: The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated, before commencing treatment with the veterinary medicinal product.
Danish: Leverfunktionen skal undersøges hos hunde, der er under mistanke for at have en leverlidelse eller dysfunktion, inden behandlingen med veterinærlægemidlet iværksættes.
English: MTP inhibitors (microsomal trigylyceride transfer protein inhibitors) as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental
Danish: Gruppen af MTP-hæmmerne (microsomal triglyceride transfer protein inhibitors) har potentiale til at forstyrre udviklingen af blommesækken, og laboratorieundersøgelser i rotter og kaniner og har vist tegn på, at de er embryoletale, teratogene og reproduktionstoksiske.
English: Any indication of progressive liver damage or of dysfunction should result in discontinuation of treatment.
Danish: Enhver indikation på udvikling af leverskade eller af nedsat leverfunktion skal medføre afbrydelse af behandlingen.
English: Where the veterinary medicinal product has been administered on food, discard unconsumed food immediately to avoid unintentional ingestion by other animals or persons in the household.
Danish: Kassér straks levnet foder, hvis veterinærlægemidlet er doseret i foderet for at undgå, at andre dyr eller personer i husholdningen indtager det utilsigtet.
English: In clinical trials, treated dogs rapidly regained weight following cessation of treatment when diet was not restricted.
Danish: I kliniske forsøg tog de behandlede hunde hurtigt på i vægt efter behandlingens afslutning, når foderet ikke blev reduceret.
English: Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the veterinary medicinal product and dose adjustments are made monthly according to effect as described below.
Danish: Efter disse første 4 ugers behandling skal hunden vejes månedligt gennem behandlingen med veterinærlægemidlet og der skal foretages månedlige dosisjusteringer i overensstemmelse med effekten beskrevet senere.
English: Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment and dose adjustments are made monthly according to effect as described below.
Danish: Efter disse første 4 ugers behandling skal hundene vejes månedligt gennem behandlingen og der skal månedligt foretages dosisjusteringer i overensstemmelse med effekten, som beskrevet senere.
English: Resolution of adverse reactions will occur shortly after the suspension of treatment.
Danish: Bivirkningerne ophører kort efter afslutning af behandlingen.
English: These signs will resolve spontaneously following treatment discontinuation.
Danish: Disse symptomer forsvinder spontant efter seponering af behandlingen.
English: Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 5 år Opbevaringstid efter første åbning af den indre emballage: 3 måneder
English: Do not use in dogs during pregnancy and lactation.
Danish: Må ikke anvendes til hunde under drægtighed og diegivning.
English: Fertility studies have not been conducted in the target species - use in dogs intended for breeding should be subject to a risk-benefit analysis by your veterinarian.
Danish: Undersøgelser vedrørende formeringen er ikke foretaget hos hunde - brug til en avlshund skal derfor vurderes af dyrlægen.
English: Any clinical indication of liver disease or dysfunction during treatment should be investigated through the evaluation of liver function.
Danish: Enhver klinisk indikation på leverlidelse eller nedsat leverfunktion under behandlingen skal undersøges ved leverfunktionsprøver.
English: Dogs should undergo a physical examination by a veterinarian before commencing treatment, and a desired bodyweight or body condition score identified.
Danish: Før behandling skal hunden undersøges af en dyrlæge og der skal fastlægges et ønsket mål for legemsvægt eller kondition.
English: Slentrol must not be used during pregnancy and lactation.
Danish: Slentrol må ikke gives under drægtighed og diegivning.
English: Although not observed in clinical trials, in the case where bodyweight loss since previous monthly weighing has been 12% per month (equivalent to 0.4% bodyweight per day), the dose should be reduced by 25%.
Danish: Selv om det ikke er forekommet i kliniske undersøgelser, og i tilfælde hvor vægttabet siden den foregående måneds vejning har været ≥12 % pr. måned (svarende til 0,4 % legemsvægt dagligt), skal dosisvolumen reduceres med 25 %.
English: When the veterinary medicinal product is drawn into syringe, administer immediately.
Danish: Veterinærlægemidlet administreres umiddelbart efter afmåling i en sprøjte.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Søg straks lægehjælp, hvis produktet indtages ved et uheld og vis indlægssedlen eller etiketten til lægen.
English: The duration of treatment with the veterinary medicinal product must not exceed 12 months and the dose of the veterinary medicinal product must not exceed a maximum of 0.2 ml/kg current bodyweight
Danish: Behandlingsvarigheden med veterinærlægemidlet må ikke overskride 12 måneder, og dosis af veterinærlægemidlet må ikke overskride 0,2 ml/kg aktuel legemsvægt (1 mg/kg dirlotapid).
English: In order to avoid this rebound weight gain, it is necessary during treatment or at the end of treatment at the latest, to establish the appropriate level of food intake and physical activity needed to ensure long term maintenance of the bodyweight.
Danish: For at undgå dette tilbagefald, er det nødvendigt under eller senest efter afslutning af behandlingen at fastlægge en passende fodrings- og motionsplan for at sikre en vedvarende vedligeholdelse af legemsvægten.
English: Bottles of 20 ml are packed with two dosing devices of 1 ml.
Danish: Flasker på 20 ml er forsynet med to doseringssprøjter på 1 ml.
English: If the bodyweight loss since previous monthly weighing has been 3% bodyweight per month (equivalent to 0.1% bodyweight per day); the dose (number of ml administered) should be kept the same.
Danish: Hvis tabet af legemsvægt siden sidste måneds vejning er ≥3 % pr. måned (svarende til 0,1 % legemsvægt daglig) skal dosis (antal ml) fortsætte.
English: The recommended starting dose is 0.05 mg/kg initial bodyweight per day (0.01 ml/kg/day).
Danish: Den anbefalede daglige initialdosis er 0,05 mg/kg af udgangslegemsvægten (0,01 ml/kg/dag).
English: Dogs should undergo a physical examination before commencing treatment, and a desired bodyweight or a body condition score identified.
Danish: Før behandling skal hunden undersøges og der skal fastlægges et ønsket mål for legemsvægt eller kondition.
English: Bottles of 150 ml are packed with two dosing devices of 10 ml.
Danish: Flasker på 150 ml er forsynet med to doseringssprøjter på 10 ml.
English: In clinical studies, vomiting, sometimes accompanied by signs of lethargy, anorexia or diarrhoea was observed during treatment with the veterinary medicinal product.
Danish: I kliniske undersøgelser blev der under behandlingen med veterinærlægemidlet somme tider set opkastning ledsaget af sløvhed, appetitløshed eller diarré.
English: Fourth monthly weighing where bodyweight loss < 3% per month since previous weighing
Danish: Fjerde månedlige vejning hvor vægttabet er <3 % pr. måned siden sidste vejning.
English: Bottles of 50 ml are packed with two dosing devices of 3 ml.
Danish: Flasker på 50 ml er forsynet med to doseringssprøjter på 3 ml.
English: The recommended starting dose of Slentrol is 0.05 mg/kg (0.01ml/kg) by oral administration.
Danish: Den anbefalede startdosis af Slentrol er 0,05 mg/kg (0,01 ml/kg) til indgift gennem munden.
English: Sporadic and mild ALT (alanine aminotransferase) elevations up to 4 times the upper reference range and not associated with histopathological liver lesions or noticeable changes in other liver parameters may be observed in some dogs during the course of treatment.
Danish: Hos nogle hunde blev der under behandlingen observeret sporadisk og mild stigning i ALT (alaninaminotransferase) op til 4 gange det øverste referenceområde uden sammenhæng med histopatologiske leverskader eller mærkbare forandringer i andre leverparametre.
English: Orion Pharma Animal Health Tel: +46 (0)8 623 64 40
Danish: Orion Pharma Animal Health Tlf: +45 49 12 67 65
English: Third monthly weighing where bodyweight loss < 3% per month since previous weighing
Danish: Tredje månedlige vejning hvor vægttabet er <3 % pr.måned siden sidste vejning.
English: The recommended starting dose of the veterinary medicinal product is 0.05 mg/kg initial bodyweight per day (0.01 ml/kg/day).
Danish: Den anbefalede daglige startdosis af veterinærlægemidlet er 0,05 mg/kg (0,01 ml/kg/dag) af den oprindelige legemsvægt.
English: Do not use during pregnancy or lactation.
Danish: Må ikke anvendes under drægtighed eller diegivning.
English: In case of contact with the skin, wash off any veterinary medicinal product immediately with soap and
Danish: Vask straks med sæbe og vand, hvis veterinærlægemidlet kommer i kontakt med huden.
English: Sverige
Danish: Danmark
English: Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term maintenance of the bodyweight.
Danish: Derfor skal der iværksættes en passende fodrings- og motionsplan for at sikre en vedvarende vedligeholdelse af legemsvægten.
English: If your dog suffers from repeated vomiting, diarrhoea or significantly reduced appetite and excessive weight loss, you should consult your veterinary surgeon who may
Danish: Hvis hunden bliver ved med at kaste op, har diarré eller markant nedsat madlyst og et stærkt vægttab, skal dyrlægen kontaktes, og det kan måske blive nødvendigt at stoppe behandlingen.
English: DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Danish: DOSERINGSTABEL TIL VÆGTTAB Dosisniveau
English: ADVERSE REACTIONS
Danish: SÆRLIG ADVARSEL
English: Do not use in dogs in the growth phase.
Danish: Må ikke anvendes til ikke udvoksede hunde.
English: If accidental eye exposure occurs, flush the eyes immediately with clean
Danish: Skyl straks øjet med rent vand, hvis veterinærlægemidlet ved et uheld kommer i øjet.
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Actira and associated names (See Annex 1).
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003, for Actira og tilknyttede navne (se bilag I).
English: Oral use
Danish: Oral användning
English: Berkshire RG14 1JA UK
Danish: Berkshire RG14 1Ja Storbritannien
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT and SE on 5 December 2006.
Danish: Denne procedure er en indbringelsesprocedure efter en gensidig anerkendelsesprocedure vedrørende ovennævnte ansøgning om ændring, som blev indgivet for Actira filmovertrukne tabletter den 5. december 2006 til Tyskland som referencemedlemsstat og de berørte medlemsstater AT, BE, DK, EL, ES, FI, IT, LU, PT og SE.
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Danish: Actira filmovertrukne tabletter indeholder 400 mg moxifloxacin som hydrochlorid.
English: Film-coated tablet
Danish: Filmdragerade tabletter
English: The MRP variation application DE/H/158/01/II/32 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Danish: Ansøgningen om ændring under proceduren for gensidig anerkendelse DE/H/158/01/II/32 vedrørte en udvidelse af indikationen til at omfatte let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis.
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 00144 Roma
Danish: Viale Shakespeare, 47 00144 Rom
English: AT - Austria
Danish: AT - Österrike
English: ACTIRA 400 MG
Danish: Actira 400 mg 400 mg
English: Objections and concerns over the efficacy and safety of Actira in the proposed indication were raised during the Mutual Recognition variation procedure.
Danish: I løbet af den gensidige anerkendelsesprocedure vedrørende ændringen blev der rejst indsigelser og betænkeligheder vedrørende effekten og sikkerheden ved Actira i forbindelse med den ansøgte indikation.
English: EL - Greece
Danish: EL - Grekland
English: QUÍMICA FARMACEUTICA BAYER, S. L.
Danish: QUÍMICA FARMACEUTICA BAYER, S. L. Av. Baix Llobregat, 3 y 5
English: Av. Baix Llobregat, 3 y 5 08970 Sant Joan DespiBarcelona
Danish: 08970 Sant Joan Despi - Barcelona Spain
English: LU - Luxembourg Bayer Healthcare AG 51368 Leverkusen
Danish: LU - Luxemburg Bayer HealthCare AG 51368 Leverkusen
English: - The Committee considered that robust data is available showing the efficacy of Actira in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Danish: - Udvalget var af den opfattelse, at der eksisterer fyldestgørende data for virkningen af Actira i forbindelse med indikationen "Behandling af let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis", dog må moxifloxacin på grund af fremkomsten af resistens over for N. gonorrhoeae ikke anvendes i empirisk monoterapi, medmindre moxifloxacin-resistent N. gonorrhoeae kan udelukkes.
English: Pharmaceutical Form
Danish: Läkemedelsform Administreringssätt
English: Marketing Authorisation Holder
Danish: Innehavare av godkännande för försäljning Läkemedlets namn Styrka
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Actira and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Actira and associated names (see Annex I).
Danish: - CHMP anbefalede derfor, at der for Actira og tilknyttede navne (se bilag I) foretages ændring af afsnit 4.1, 4.2, 4.3, 4.4, 5.1 og 5.2 i produktresuméet samt relevante afsnit af indlægssedlen som beskrevet i bilag III.
English: 7.5 mg/kg
Danish: > 0.5 mg/l
English: Susceptible
Danish: Følsomhed
English: 5.4 mg/kg
Danish: 4 mg/l
English: EU/1/18/1335/001 POTELIGEO 4 mg/ml
Danish: EU/1/18/1335/001 POTELIGEO 4 mg/ml Koncentrat til infusionsvæske, opløsning intravenøs anvendelse hætteglas
English: 1 vial
Danish: 1 stk
English: Dogs were followed for 18 weeks after treatment.
Danish: Hundene blev fulgt i 18 uger efter behandling.
English: Area vascularity should be maintained.
Danish: Vaskularisering af området bør opretholdes.
English: Summary of the cumulative percent of fracture unions by week and treatment Weeks
Danish: Resumé af kumulativ procent af frakturheling for uge og behandling Uger
English: Do not use more than 3.2 ml.
Danish: Anvend ikke mere end 3,2 ml.
English: Follow the instructions for preparation below.
Danish: Følg anvisningerne for klargøring nedenfor.
English: Date of first authorisation: 14/12/2011 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 14/12/2011 Dato for seneste fornyelse af markedsføringstilladelse:
English: Dry the fracture site to the extent possible.
Danish: Tør frakturstedet i det omfang det er muligt.
English: The kit also includes:
Danish: Sættet indeholder også:
English: For reconstitution.
Danish: Til rekonstitution.
English: TruScient is active at the site of implantation.
Danish: TruScient er aktivt på implantationsstedet.
English: In the case of dogs receiving concentrations or amounts greater than those recommended, treatment of adverse effects, where required, should be symptomatic.
Danish: I tilfælde, hvor hunde får højere koncentrationer eller større mængder end de anbefalede, bør behandling af bivirkninger, når det er påkrævet, være symptomatisk.
English: Development of BMP-2 antibodies occurred in 6.9% of dogs receiving TruScient vs. 4.3% of dogs in the control group.
Danish: Udvikling af BMP-2 antistoffer forekom hos 6,9 % af de hunde, der fik TruScient vs. 4,3 % af hundene i kontrolgruppen.
English: The possibility of an immune response to the product should be evaluated in cases where an undesirable effect with immunological background is suspected.
Danish: Risikoen for en immunologisk reaktion over for produktet skal vurderes i tilfælde hvor der er mistanke om en bivirkning med immunologisk baggrund.
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Danish: Det højeste niveau af cirkulerende dibotermin alfa (0,1 % af den implanterede dosis) blev observeret inden for 6 timer efter implantationen.
English: No studies have been performed in dogs with known autoimmune diseases.
Danish: Der er ikke udført studier med hunde med kendte autoimmune sygdomme.
English: BMP-2 plays a critical role during foetal development.
Danish: BMP-2 har en kritisk funktion under den føtale udvikling.
English: The influence of anti-BMP-2 antibody formation on foetal development has not been assessed.
Danish: Indflydelsen af anti-BMP-2 antistofdannelse på føtal udvikling er ikke undersøgt.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian surgeon.
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: Therefore, in the absence of clinical data, the veterinary medicinal product should not be used for direct applications to trabecular bone when transient bone resorption may create a risk of bone fragility and, thus, increase the risk of implant failure.
Danish: Derfor, i mangel af kliniske data, bør veterinærlægemidlet ikke anvendes til applikation direkte på trabekulær knogle, når forbigående knogleresorption kan udgøre en risiko for knogleskørhed og dermed øge risikoen for mislykket implantation.
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats.
Danish: Ved intravenøs injektion var den terminale halveringstid for dibotermin alfa 16 minutter hos rotter.
English: This medicinal product should only be used in breeding, pregnant and lactating dogs following a risk/benefit assessment by the responsible veterinarian.
Danish: Dette veterinære lægemiddel bør kun anvendes hos avlshunde, drægtige og diegivende tæver efter en vurdering af risici/fordele af den ansvarlige dyrlæge.
English: TruScient should be used by an appropriately qualified veterinarian.
Danish: TruScient bør anvendes af en dyrlæge med passende kvalifikationer.
English: 10 ml Do not use more than 3.2 ml for reconstitution
Danish: 10 ml Anvend ikke mere end 3,2 ml til rekonstitution
English: Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Danish: Behandling af frakturer af lange knogler og bløddele bør være baseret på almindelig praksis, herunder kontrol af infektion.