FrancophonIA/ELRC3.0 huggingface dataset:
English: Cattle: Subcutaneous use Pigs: Intramuscular use Read the package leaflet before use.
Danish: Kvæg: subkutan anvendelse Svin: intramuskulær anvendelse Læs indlægssedlen inden brug.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
English: Subcutaneous injection.
Danish: Subkutan injektion.
English: In vitro plasma protein binding studies determined that the mean concentration of the free active drug was 77 %.
Danish: plasmaproteinbinding viste, at den gennemsnitlige koncentration af frit aktivt stof var 77 %.
English: Gamithromycin skin concentrations were much higher than the plasma concentrations resulting in skin/plasma concentration ratios of approximately 21, 58, and 138 at two, five and ten days post-dosing, respectively, demonstrating extensive distribution and accumulation in skin tissue.
Danish: Gamithromycinkoncentrationen var meget højere i hud end i plasma, hvilket resulterede i en hud/plasma koncentrationsratio på ca. 21, 58 og 138 hhv. to, fem og ti dage efter dosering.
English: Antiinfectious agents / Antibiotics
Danish: Antiinfektiøse lægemidler/an tibiotika
English: Do not use in pregnant cows and heifers which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke anvendes til drægtige køer og kvier, hvis mælk er bestemt til menneskeføde, inden for 2 måneder forud for den forventede kælvningsdato.
English: Cattle, sheep and pigs.
Danish: Kvæg, får og svin.
English: The compound is absorbed rapidly into the target tissue for SRD.
Danish: Stoffet absorberes hurtigt i målvævet i forb.m.
English: 1 ml contains 150 mg of gamithromycin,
Danish: 1 ml indeholder 150 mg gamithromycin,
English: SC (cattle, sheep), IM (pigs)
Danish: s.c. (kvæg, får), i.m.
English: Pharmaco-logically active substance
Danish: Det farmakologisk aktive stof
English: The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae,Haemophilus parasuis and Bordetella bronchiseptica, the bacterial pathogens most commonly associated with BRD and SRD, and also Fusobacterium necrophorum and Dichelobacter nodosus.
Danish: Gamithromycin har et bredt antimikrobielt spektrum: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae, Haemophilus parasuis og Bordetella bronchiseptica, de hyppigst forekomne bakterielle patogener i forbindelse med BRD og SRD, samt Fusobacterium necrophorum og Dichelobacter nodosus.
English: For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site.
Danish: Ved behandling af kvæg med en legemsvægt over 250 kg og får med en legemsvægt over 125 kg, bør dosis deles, således at der ikke injiceres mere end 10 ml (kvæg) eller 5 ml (får) per injektionssted.
English: For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) and 5 ml (sheep) are injected at a single site.
Danish: Ved behandling af kvæg med en legemsvægt over 250 kg og får med en legemsvægt over 125 kg, bør dosis deles, således at der ikke injiceres mere end 10 ml (kvæg) og 5 ml (får) pr. injektionssted.
English: 1 ml contains 150 mg of gamithromycin
Danish: 1 ml indeholder 150 mg gamithromycin
English: Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for en vis type af antibiotika, kaldet makrolider, eller over for nogen af hjælpestofferne.
English: Pharmacotherapeutic group: Antibacterials for systemic use, macrolides ATC vet code: QJ01FA95.
Danish: Farmakoterapeutisk gruppe: Antibakterielle midler til systemisk brug, makrolider.
English: Based on laboratory animal data, gamithromycin has not produced any evidence of specific developmental or reproductive effects.
Danish: Undersøgelser på laboratoriedyr har ikke vist nogen negativ indflydelse på udvikling eller reproduktion.
English: Biliary excretion of the unchanged drug substance was the major route of elimination.
Danish: Galdevejene var den væsentlige rute for udskillelse af uomsat stof.
English: • Visible injection site swellings associated with occasional slight pain may develop very commonly in cattle for one day.
Danish: • Synlige hævelser på injektionsstedet, af og til forbundet med let smerte i en dag, er meget almindelige hos kvæg.
English: • Mild to moderate injection site swelling has been reported commonly in sheep and pigs in clinical trials, with occasional slight pain evident for one day in sheep.
Danish: • Milde til moderate hævelser på injektionsstedet var almindelige hos får og svin i kliniske undersøgelser, af og til forbundet med let smerte i en dag hos får.
English: Gamithromycin administered subcutaneously into the neck of sheep at a single dose of 6 mg/kg body weight is rapidly absorbed, and maximum plasma concentrations were observed between 15 minutes and 6 hours after dosing (2.30 hours on average) with high absolute bioavailability of 89%.
Danish: Gamithromycin, administreret subkutant i halsen på får ved en dosis på 6 mg/kg legemssvægt, absorberes hurtigt, og højeste plasmakoncentrationer sås efter 15 minutter til 6 timer efter doseringen (2,30 timer i gennemsnit) med høj absolut biotilgængelighed på 89 %.
English: A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep).
Danish: 1 ml/25 kg legemsvægt) i halsen (kvæg og svin) eller foran skulderpartiet (får).
English: Pigs: intramuscular injection.
Danish: Svin: intramuskulær injektion.
English: Polypropylene vial of 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Danish: Polypropylen-hætteglas indeholdende 100, 250 eller 500 ml med chlorbutyl gummiprop, polypropylen hætte og en krympeforsegling af aluminium.
English: Do not use in pregnant animals which are intended to produce milk for human consumption, within 2 months (cows, heifers) or 1 month (ewes) of expected parturition.
Danish: Må ikke anvendes til drægtige dyr, hvis mælk er bestemt til menneskeføde, inden for 2 måneder (køer, kvier) eller 1 måned (får) forud for den forventede fødselsdato.
English: Type 1 glass vial of 50, 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Danish: Hætteglas type-1-glas indeholdende 50, 100, 250 eller 500 ml med chlorbutyl gummiprop, polypropylen hætte og en krympeforsegling af aluminium.
English: Meat and offal: Cattle: 64 days.
Danish: Slagtning: Kvæg: 64 dage.
English: 50 μg/kg 300 μg/kg 200 μg/kg
Danish: 50 μg/kg 50 μg/kg 300 μg/kg 200 μg/kg
English: Pigs Intramuscular injection.
Danish: Svin Intramuskulær injektion.
English: Cattle, sheep, pigs
Danish: Kvæg, får, svin
English: Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for makrolidantibiotika eller nogen af hjælpestofferne.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial after EXP. Shelf-life after first opening the container: 28 days.
Danish: Dette veterinære lægemiddel må ikke anvendes efter den udløbsdato, som er angivet på hætteglasset efter EXP.
English: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Behandling og metafylakse af respirationsvejslidelser (BRD) hos kvæg forårsaget af infektioner med Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS VIAL 50 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas (50 ml)
English: Porcine 100 μg/kg 100 μg/kg
Danish: Svin 100 μg/kg 100 μg/kg
English: • Very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Danish: • Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)
English: • Common (more than 1 but less than 10 animals in 100 animals treated)
Danish: • Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr)
English: Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life (> 2 days).
Danish: Gamithromycin, administreret subkutant i halsen på kvæg ved en dosis på 6 mg/kg legemsvægt, resulterede i hurtig absorption med højeste plasmakoncentrationer efter 30 til 60 minutter med en lang plasmahalveringstid (> 2 dage).
English: Gamithromycin administered intramuscularly in pigs at single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 5 to 15 min, with a long plasma half-life (about 4 days).
Danish: Gamithromycin, administreret intramuskulært i svin ved en dosis på 6 mg/kg legemsvægt, resulterede i hurtig absorption med højeste plasmakoncentrationer efter 5 til 15 minutter med en lang plasmahalveringstid (> 4 dage).
English: D.
Danish: SRD.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske (50 ml, 100 ml, 250 ml)
English: Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.
Danish: Behandling af respirationslidelser hos svin (SRD) forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis og Bordetella bronchiseptica.
English: The efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management.
Danish: Faktorer såsom våde omgivelser samt uhensigtsmæssig management kan nedsætte virkningen af antimikrobiel behandling af klovsyge.
English: • Rare (more than 1 but less than 10 animals in 10,000 animals treated)
Danish: • Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr)
English: Not authorised for use in lactating animals producing milk for human consumption.
Danish: Må ikke anvendes til lakterende dyr hvis mælk er bestemt til menneskeføde.
English: Shelf life after first opening the container: 28 days Once opened, use by __/__/__
Danish: Opbevaringstid efter første åbning af beholderen: 28 dage.
English: Not for use in animals producing milk for human consumption
Danish: Ikke til dyr, hvis mælk er bestemt til menneskeføde
English: • Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Danish: • Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL 100 ml, 250 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas (100 ml, 250 ml)
English: Interaction with other medicinal products and other forms of interaction: Cross resistance may occur with other macrolides.
Danish: Interaktion med andre lægemidler og andre former for interaktion:
English: B.
Danish: BRD.
English: Bovine 20 μg/kg 200 μg/kg
Danish: Gamithromycin Gamithromycin Kvæg 20 μg/kg 200 μg/kg
English: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
Danish: ZACTRAN 150 mg/ml, injektionsvæske, opløsning, til kvæg, får og svin
English: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs Gamithromycin
Danish: ZACTRAN 150 mg/ml, injektionsvæske, opløsning til kvæg, får og svin gamithromycin
English: ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin
Danish: ZACTRAN 150 mg/ml, injektionsvæske, opløsning til kvæg og svin Gamithromycin
English: PACKAGE LEAFLET: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
Danish: INDLÆGSSEDDEL ZACTRAN 150 mg/ml, injektionsvæske, opløsning til kvæg, får og svin
English: Active substance: 150 mg of gamithromycin Excipients: 1 mg of monothioglycerol Colourless to pale yellow solution.
Danish: Aktivt indholdsstof: 150 mg gamithromycin.
English: SC (cattle) IM (pigs) Read the package leaflet before use.
Danish: (svin) Læs indlægssedlen inden brug.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL 500 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas (500 ml)
English: Solution for injection
Danish: Bortskaffelse: Læs indlægssedlen
English: Benefit/Risk Assessment
Danish: Benefit/risk-vurdering
English: The scientific value of these papers is rather limited.
Danish: Den videnskabelige værdi af disse dokumenter er ret begrænset.
English: GROUNDS FOR REFUSAL
Danish: BEGRUNDELSE FOR AFSLAG
English: The publications were grouped in three chapters according to the indications:
Danish: Publikationerne var grupperet i tre kapitler efter indikationer:
English: None of the CHMP questions were sufficiently answered.
Danish: Ingen af CHMP's spørgsmål var tilstrækkeligt besvaret.
English: A similar range is recommended in the Product Information in most countries.
Danish: Et tilsvarende interval anbefales i produktinformationen i de fleste lande.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MYDERISON
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF MYDERISON
English: It means that all drugs which metabolism depends on the activity of this system may potentially interact with tolperisone or vice versa.
Danish: Det betyder, at alle lægemidler, hvis metabolisering afhænger af dette systems aktivitet, potentielt kan interagere med tolperison eller vice versa.
English: A Potential Serious Risk for Public Health was raised by the Czech Republic, Lithuania and Slovakia.
Danish: Den Tjekkiske Republik, Litauen og Slovakiet gjorde opmærksom på en potentiel alvorlig risiko for folkesundheden.
English: The Marketing Authorisation Holder, Meditop Pharmaceutical Co. Ltd., was applying for marketing authorisations for Myderison in Czech Republic, Germany, Lithuania, Poland, Romania and Slovakia.
Danish: Indehaveren af markedsføringstilladelsen, Meditop Pharmaceutical Co. Ltd., ansøgte om markedsføringstilladelse for Myderison i Den Tjekkiske Republik, Tyskland, Litauen, Polen, Rumænien og Slovakiet.
English: The highly variable PK needs to be carefully addressed since the potential efficacy and safety implications are high.
Danish: Den meget varierende farmakokinetik skal undersøges nøje, da de potentielle implikationer for virkning og sikkerhed er store.
English: The third indication of Mydeton, rehabilitation after orthopaedic and traumatological surgery, is supported only by two observational studies.
Danish: Den tredje indikation for Mydeton, revalidering efter ortopæd- og traumekirurgi, støttes kun af to observationsundersøgelser.
English: The CHMP considered that the “Well-Established” use in accordance to Article 10(a) of Directive 2001/83/EC for Myderison has not been demonstrated.
Danish: CHMP konkluderede, at "almindelig anerkendt anvendelse" i overensstemmelse med artikel 10, stk. 1, litra a), i direktiv 2001/83/EF for Myderison ikke er dokumenteret.
English: Some information on the safety of tolperisone can only be collected from the publications submitted to support the use of tolperisone in selected indications, mentioned above.
Danish: Nogle oplysninger om tolperisons sikkerhed kan kun indsamles fra publikationer, som er indsendt til støtte for anvendelse af tolperison til udvalgte indikationer som nævnt ovenfor.
English: Out of the other publications six reported on the results of comparative, but open studies, and tolperisone was used added on to a very complex (medicinal and physical) combined therapy.
Danish: Af de øvrige publikationer rapporterede seks om resultaterne af sammenlignende, men dog åbne undersøgelser, og tolperison blev anvendt som tillæg til en meget kompliceret (medicinsk og fysisk) kombinationsbehandling.
English: Furthermore, the oral dose might need to be individualised within the recommended dose range 150-450 mg / day according to the clinical needs.
Danish: Desuden kunne der være behov for at individualisere den orale dosis inden for det anbefalede dosisinterval på 150-450 mg/dag alt efter klinisk behov.
English: Tolperisone is metabolised by the cytochrome P450 system in particular CYP2D6.
Danish: Tolperison metaboliseres af cytokrom P450-systemet, især CYP2D6.
English: In summary, there are no data on PK/PD relationship, no confirmation of sufficient efficacy and safety in such a variable PK and the dosing has not been properly selected, as well.
Danish: Sammenfattende foreligger der ingen data om PK/PD-forhold, ingen bekræftelse af tilstrækkelig virkning og sikkerhed i en så variabel farmakokinetik, og doseringen er heller ikke valgt korrekt.
English: The majority of clinical studies with tolperisone have been performed in a dose range of 150-450 mg/day.
Danish: De fleste kliniske undersøgelser med tolperison er udført i et dosisinterval på 150-450 mg/dag.
English: This procedure concerns a bibliographic application of tolperisone film-coated tablets with Hungary as the Reference Member State in the Mutual Recognition Procedure (MRP).
Danish: Denne sag vedrører en ansøgning baseret på bibliografiske data for tolperison filmovertrukne tabletter med Ungarn som referencemedlemsstat i forbindelse med proceduren for gensidig anerkendelse (MRP).
English: However there was no significant difference in the mobility of patients treated with tolperisone or placebo.
Danish: Der var dog ingen signifikant forskel i mobilitet hos patienter behandlet med tolperison i forhold til patienter behandlet med placebo.
English: From these 15 publications only one (Pratzel et al 1996) was published in an international peer reviewed journal that had acceptable standard and scientific value (double blind, randomised, placebo controlled).
Danish: Af disse 15 publikationer var kun en (Pratzel et al 1996) publiceret i et internationalt tidsskrift med peer review, som havde en acceptabel standard og videnskabelig værdi (dobbeltblindet, randomiseret, placebokontrolleret).
English: The originator medicinal product is Mydeton and it was developed by Gedeon Richter, Ltd.
Danish: Originalpræparatet er Mydeton, som er udviklet af Gedeon Richter, Ltd.
English: The other papers only refer to observational studies, congress-reports or reviews (published in Hungarian) having limited scientific value.
Danish: De øvrige dokumenter refererer kun til observationsundersøgelser, kongresrapporter eller gennemgange (publiceret på ungarsk) og har derfor begrænset videnskabelig værdi.
English: However in this trial the majority of the patients had taken tolperisone in higher dose than recommended in the SPC of the originator product.
Danish: I denne undersøgelse havde de fleste af patienterne imidlertid taget tolperison i højere doser end anbefalet i originalpræparatets produktresumé.
English: The CHMP acknowledged that there is a lack of reliable dose finding studies in publicly available sources but did not find enough justifications to support the claimed daily dose recommendation.
Danish: CHMP erkendte, at der mangler pålidelige dosisfindingsundersøgelser i offentligt tilgængelige kilder, men fandt ikke tilstrækkelige begrundelser for at støtte anbefalingen af den angivne daglige dosis.
English: The MAH presented a new study report, MDTP-T20091B, which was a PK study sponsored by Meditop performed in 48 healthy volunteers.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en ny undersøgelsesrapport, MDTP-T20091B, som var en farmakokinetisk undersøgelse sponsoreret af Meditop og udført på 48 raske frivillige forsøgspersoner.
English: No data of epidemiological studies on the safety of tolperisone in clinical use have been provided.
Danish: Der er ikke indsendt data vedrørende epidemiologiske undersøgelser af tolperisons sikkerhed ved klinisk anvendelse.
English: The CHMP considered that it was not clear whether tolperisone has also been registered in other EU countries or only in the countries mentioned by the MAH.
Danish: CHMP mente ikke, at det var klart, om tolperison også er registreret i andre EU-lande eller kun i de lande, som blev nævnt af indehaveren af markedsføringstilladelsen.
English: The CHMP noted that no formal or specific drug interaction studies have been performed.
Danish: CHMP bemærkede, at der ikke er udført formelle eller specifikke lægemiddelinteraktionsundersøgelser.
English: From these 6 papers only one (Stamenova et al. 2005) was published in an international peer reviewed journal.
Danish: Af disse 6 dokumenter var kun et (Stamenova et al. 2005) publiceret i et internationalt tidsskrift med peer review.
English: In view of the above the CHMP considered that information to justify the proposal for section 4.5 of the SPC was missing and therefore no conclusions could be reached on this regards.
Danish: I lyset af ovenstående mente CHMP, at de oplysninger, som kunne begrunde det foreslåede punkt 4.5 i produktresuméet, manglede og kunne derfor ikke nå frem til nogen konklusioner i den henseende.
English: - the documentation submitted is not sufficient to cover all aspect of the efficacy and safety assessment of tolperisone, in particular to justify the claimed therapeutic indication and posology.
Danish: - den indsendte dokumentation er ikke tilstrækkelig til dække alle aspekter af virknings- og sikkerhedsvurderingen af tolperison, især med hensyn til at begrunde den angivne terapeutiske indikation og dosis.
English: These data show that tolperisone was well tolerated in clinical use, and the side effects (generalized body weakness, fatigue, and dizziness) observed in these clinical trials were usually mild or moderate and did not necessitate the discontinuation of the treatment.
Danish: Disse data viser, at tolperison var veltolereret ved klinisk anvendelse, og at de bivirkninger (generel slaphed i kroppen, træthed og svimmelhed), som blev observeret i disse kliniske undersøgelser, normalt var milde eller moderate og ikke nødvendiggjorde seponering af behandlingen.
English: The trial was a placebo controlled, randomised, double blind dose-titration study of high standard.
Danish: Undersøgelsen var en placebokontrolleret, randomiseret, dobbeltblindet, dosistitreringsundersøgelse af høj standard.
English: The clinical relevance of interindividual variability of tolperisone PK and the potential impact of CYP2D6 polymorphism of the drug are unknown.
Danish: Den kliniske relevans af interindividuel variabilitet af tolperisons farmakokinetik og den potentielle indvirkning af lægemidlets CYP2D6-polymorfisme er ukendt.
English: The Marketing Application of Myderison had been submitted under the WEU (well established use) legal basis.
Danish: Ansøgningen om markedsføringstilladelse for Myderison blev indgivet i henhold til WEU-retsgrundlaget (almindelig anerkendt anvendelse).
English: The CHMP recommended the refusal of the granting of the Marketing Authorisation in the Concerned Member States and the revocation of the Marketing Authorisation for Myderison where the product is currently authorised.
Danish: anbefalede CHMP, at der gives afslag på markedsføringstilladelse i de berørte medlemsstater, og at markedsføringstilladelsen for Myderison tilbagekaldes i de medlemsstater, hvor lægemidlet er godkendt på nuværende tidspunkt.
English: The sources were not validated, not all the MAHs and data related to non various generic products were included.
Danish: Kilderne var ikke valideret, ikke alle indehavere af markedsføringstilladelser og data vedrørende ikke-forskellige generiske lægemidler var medtaget.
English: The other papers contain results of various observational studies, congress reports, and surveys (published in Hungarian).
Danish: De øvrige dokumenter indeholder resultater af forskellige observationsundersøgelser, kongresrapporter og andre undersøgelser (publiceret på ungarsk).