FrancophonIA/ELRC3.0 huggingface dataset:
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Danish: De veterinære lægemidler Suanovil 20, injektionsvæske, opløsning, og det tilsvarende generiske produkt, Captalin, er injektionsvæsker, opløsning, der indeholder 20 g spiramycin/100 ml, svarende til 600 000 IE spiramycin/ml.
English: No sufficient data or no data at all are available for all other indications and dosage regimens in cattle (i.e. metritis, enteric infections, omphalitis, omphalophlebitis, arthritis, interdigital abscesses) and all indications in pigs.
Danish: For alle andre indikationer og dosisregimer hos kvæg er data utilstrækkelige eller mangler helt (dvs. metritis, enteriske infektioner, omfalitis, omfaloflebitis, artritis, interdigitale abscesser), hvilket ligeledes gælder alle indikationer hos svin.
English: Do not administer more than 20 ml per injection site.
Danish: Der må højst gives 20 ml på hvert injektionssted.
English: Overall, the benefit-risk balance of all concerned products is considered positive provided their use will be limited to the treatment of bovine respiratory infections caused by susceptible strains of Pasteurella multocida and Mannheimia haemolytica at a dose of 100 000 IU/kg administered intramuscularly twice at 48 hours of interval.
Danish: Overordnet anses benefit/risk-forholdet for alle de omhandlede produkter positivt, forudsat at deres anvendelse indskrænkes til behandling af luftvejsinfektioner hos kvæg forårsaget af følsomme stammer af Pasteurella multocida og Mannheimia haemolytica med en dosis på 100 000 IE/kg intramuskulært to gange med 48 timers mellemrum.
English: By using the pharmacodynamic and pharmacokinetic data mentioned above, a detailed PK/PDassessment was performed, which was based on two parameters: the T>MIC, which is recommended for time-dependent antibiotics like the macrolides, and the AUC/MIC, which is recommended for specific macrolides like azithromycin.
Danish: På grundlag af disse data foretoges en detaljeret farmakokinetisk/farmakodynamisk vurdering baseret på to parametre: T>MIC, der anbefales anvendt for tidsafhængige antibiotika såsom makroliderne, og forholdet AUC/MIC, der anbefales anvendt for bestemte makrolider såsom azithromycin.
English: Meat and offal: 68 days.
Danish: Kød og indmad: 68 dage.
English: For the treatment of bovine respiratory diseases several appropriate clinical studies from 1988 and 1989 using the dose regime of 100 000 IU/kg body weight once or twice in 48 hours interval, have been presented.
Danish: Vedrørende behandling af luftvejssygdomme hos kvæg er der forelagt flere fyldestgørende kliniske undersøgelser fra 1988 og 1989 med doseringsregimet 100 000 IE/kg kropsvægt én eller to gange med 48 timers interval.
English: Spiramycin is able to reach so high tissue concentrations that it succeeds in penetrating into the cells to bind the 50S ribosomal subunits.
Danish: Spiramycin kan opnå så høje koncentrationer i vævet, at det kan trænge ind i cellerne og bindes til de ribosomale 50S subunits.
English: Therefore Captalin should not be used in animals producing milk for human consumption.
Danish: Captalin bør derfor ikke anvendes hos dyr, der producerer mælk til konsum.
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names, and generic products thereof, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Danish: under forudsætning af ændringer i produktinformationen, anbefalede CVMP ændring af markedsføringstilladelserne for Suanovil 20 og relaterede navne, Captalin og relaterede navne samt tilsvarende generiske produkter, idet produktresuméerne, mærkningen og indlægssedlerne ændres i henhold til bilag III.
English: Not authorised for use in animals producing milk for human consumption.
Danish: Ikke til anvendelse hos dyr, der producerer mælk til konsum.
English: Spiramycin is eliminated primarily by biliary excretion.
Danish: Spiramycin udskilles hovedsagelig gennem galden.
English: This withdrawal period is valid after administration of 100 000 IU/kg body weight twice at 48 hours of interval.
Danish: Denne tilbageholdelsestid gælder efter administration af 100 000 IE/kg kropsvægt to gange med 48-timers interval.
English: The benefit-risk balance of Suanovil 20 and Spirovet is considered positive provided that their use in the treatment of mastitis will be limited to treatment of acute bovine S. aureus-mastitis caused by susceptible strains at a dose of 30 000 IU/kg administered intramuscularly twice at 24 hours of interval.
Danish: Benefit/risk-forholdet for Suanovil 20 og Spirovet anses for positivt, forudsat at deres anvendelse ved mastitis begrænses til behandling af akut S. aureus-mastitis hos kvæg forårsaget af følsomme stammer ved en dosis på 30 000 IE/kg intramuskulært to gange med 24 timers mellemrum.
English: Do not administer more than 15 ml per injection site.
Danish: Der må højst gives 15 ml på hvert injektionssted.
English: Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica at a dose regime of 100 000 IU/kg body weight twice at 48 hours of interval.
Danish: Behandling af luftvejsinfektioner forårsaget af Pasteurella multocida og Mannheimia haemolytica i en dosering på 100 000 IE/kg kropsvægt to gange med 48-timers mellemrum.
English: 29 avenue Tony Garnier 69007- Lyon France
Danish: 29 avenue Tony Garnier 69007- Lyon Frankrig
English: Therefore Spirovet should not be used for treatment of respiratory infections in animals producing milk for human consumption.
Danish: Spirovet bør derfor ikke anvendes til behandling af luftvejsinfektioner hos dyr, der producerer mælk til konsum.
English: A. For Suanovil 20 and its associated names listed in Annex I containing 600 000 IU spiramycin per ml
Danish: A. For Suanovil 20 og relaterede navne opført i bilag I indeholdende 600 000 IE spiramycin/ml
English: Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica.
Danish: Behandling af luftvejsinfektioner forårsaget af Pasteurella multocida og Mannheimia haemolytica.
English: INDICATIONS Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica.
Danish: INDIKATIONER Behandling af luftvejsinfektioner forårsaget af Pasteurella multocida og Mannheimia haemolytica.
English: Mastitis: 30 000 IU of spiramycin per kg body weight (i.e. 5 ml of product per 100 kg body weight) twice at 24 h of interval.
Danish: Mastitis: 30 000 IE spiramycin/kg kropsvægt (dvs. 5 ml produkt pr. 100 kg kropsvægt) to gange med 24 timers mellemrum.
English: Bacteria species
Danish: Bakterieart
English: Treatment of acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains sensitive to spiramycin.
Danish: Behandling af akut klinisk mastitis hos lakterende køer forårsaget spiramycinfølsomme stammer af Staphylococcus aureus.
English: Captalin solution for injection has been authorised by severeal Member States for use in cattle for the treatment of respiratory diseases at a dose of 100 000 IU/kg body weight twice at 48 hour interval and for the metaphylaxis of respiratrory diseases at a single dose of 100 000 IU/kg body weight.
Danish: Captalin, injektionsvæske, opløsning, er godkendt i flere medlemsstater til behandling af luftvejssygdomme hos kvæg i en dosering på 100 000 IE/kg kropsvægt med 48 timers mellemrum og til metafylakse af luftvejssygdomme i en enkelt dosis på 100 000 IE/kg kropsvægt.
English: 100 000 IU of spiramycin per kg body weight (i.e. 1 ml of product per 10 kg body weight) twice at 48 h of interval.
Danish: 100 000 IE spiramycin/kg kropsvægt (dvs. 1 ml produkt pr. 10 kg kropsvægt) to gange med 48 timers mellemrum.
English: This withdrawal period is valid for Suanovil 20 administered at the dose of 30 000 IU/per kg body weight, intramuscularly twice at 24 hours of interval.
Danish: Denne tilbageholdelsestid gælder for Suanovil 20 administreret i en dosis på 30 000 IE/kg kropsvægt intramuskulært to gange med 24 timers mellemrum.
English: Spiramycin is an antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria.
Danish: Spiramycin er et antibiotikum, der virker bakteriostatisk mod Mycoplasma, gramnegative og grampositive bakterier.
English: No residue depletion data in milk was provided following the admistration of Spirovet at the dose of 30 000 IU/per kg body weight, intramuscularly twice at 24 hours of interval.
Danish: Der blev ikke forelagt restkoncentrationsdata i mælk efter administration af Spirovet i en dosis på 30 000 IE/kg kropsvægt intramuskulært to gange med 24 timers mellemrum.
English: B. For Spirovet and its associated names listed in Annex I containing 600 000 IU spiramycin per ml
Danish: B. For Spirovet og relaterede navne opført i bilag I indeholdende 600 000 IE spiramycin/ml
English: The indication was substantiated by in vitro susceptibility data for Staphylococcus aureus strains and by PK data of spiramycin in the target species, on the basis of which a detailed PK/PD assessment has been performed.
Danish: Denne indikation var underbygget af in vitro-følsomhedsdata for stammer af Staphylococcus aureus og farmakokinetiske data for spiramycin hos måldyrearten, som har dannet grundlag for en detaljeret farmakokinetisk/farmakodynamisk vurdering.
English: Respiratory infections: 100 000 IU of spiramycin per kg body weight (i.e. 5 ml of product per 30 kg body weight) twice at 48 h of interval.
Danish: Luftvejsinfektioner: 100 000 IE spiramycin/kg kropsvægt (dvs. 5 ml produkt pr. 30 kg kropsvægt) to gange med 48 timers mellemrum.
English: Treatment of acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains sensitive to spiramycin at a dose regime of 30 000 IU/kg body weight twice at 24 hours of interval.
Danish: Behandling af akut klinisk mastitis hos lakterende køer forårsaget af spiramycinfølsomme stammer af Staphylococcus aureus i et dosisregime på 30 000 IE/kg kropsvægt to gange med 24 timers mellemrum.
English: When applying these concepts it has been concluded that based on PK/PD-considerations in cattle, following 2 injections at 100 000 IU/kg body weight at 48 hours interval, the spiramycin concentrations in lung, macrophages and bronchoalveolar lavage reached the respiratory pathogens with MICs up to 128 µg/ml.
Danish: Ved hjælp af disse begreber konkluderes det, at koncentrationen af spiramycin i lunger, makrofager og bronkoalveolær lavage nåede MIC-værdier for luftvejspatogenerne på op til 128 µg/ml baseret på farmakokinetiske/farmakodynamiske forhold hos kvæg efter to injektioner af 100 000 IE/kg kropsvægt med 48 timers interval.
English: This withdrawal period is valid for Spirovet administered at the dose of 30 000 IU/per kg body weight, intramuscularly twice at 24 hours of interval.
Danish: Denne tilbageholdelsestid gælder for Spirovet i en dosis på 30 000 IE/kg kropsvægt intramuskulært to gange med 24 timers mellemrum.
English: The recommended dose for acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains susceptible to spiramycin is 30 000 IU/kg body weight, intramuscularly twice at 24 hours of interval.
Danish: Den anbefalede dosis ved akut klinisk mastitis hos lakterende køer forårsaget af spiramycinfølsomme stammer af Staphylococcus aureus er 30 000 IE/kg kropsvægt intramuskulært to gange med 24 timers mellemrum.
English: The recommended dose for respiratory infections in cattle is 100 000 IU/kg body weight, intramuscularly twice at 48 hours of interval.
Danish: Den anbefalede dosis ved luftvejinfektioner hos kvæg er 100 000 IE/kg kropsvægt intramuskulært to gange med 48 timers mellemrum.
English: Further to the efficacy assessment the recommended dose for respiratory infections in cattle is 100 000 IU/kg body weight intramuscularly twice at 48 hours of interval.
Danish: På grundlag af vurderingen af virkning er den anbefalede dosis ved luftvejsinfektioner hos kvæg 100 000 IE/kg kropsvægt intramuskulært to gange med 48 timers mellemrum.
English: Residue depletion studies performed at the dose of 100 000 IU/kg body weight, intramuscularly at 48 hours interval, were available in adult cattle.
Danish: Der forelå restkoncentrationsundersøgelser hos voksent kvæg ved en dosis på 100 000 IE/kg kropsvægt intramuskulært med 48 timers mellemrum.
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddel -form
English: Route of Administration
Danish: Indgivelsesvej
English: Rixathon received a marketing authorisation valid throughout the EU on 15 June 2017.
Danish: Rixathon fik en markedsføringstilladelse med gyldighed i hele EU den 15. juni 2017.
English: It should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Danish: Det bør gives under tæt overvågning af en erfaren sundhedsperson på et sted, hvor genoplivningsudstyr er umiddelbart tilgængeligt.
English: Further information on Rixathon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rixathon.
Danish: Yderligere information om Rixathon findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Rixathon.
English: The cancer improved in just over 87% of those given Rixathon (271 of 311 patients), and in similar numbers of those given MabThera (274 of 313 patients).
Danish: Der sås bedring af kræftsygdommen hos lidt over 87 % af de patienter, der fik Rixathon (271 ud af 311), og hos et tilsvarende antal af dem, der fik MabThera (274 ud af 313).
English: These patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have symptoms of infection.
Danish: Disse patienter skal desuden have udleveret et patientkort, som de altid skal have på sig, og som angiver, at de straks skal kontakte lægen, hvis de får symptomer på infektion.
English: Depending on the condition being treated, the patients are also given other medicines to manage side effects.
Danish: Alt efter hvilken tilstand der behandles, får patienten også andre lægemidler til håndtering af bivirkninger.
English: This means that Rixathon is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Rixathon i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: As for all medicines, data on the use of Rixathon are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Rixathon løbende overvåget.
English: Other information about Rixathon
Danish: Andre oplysninger om Rixathon
English: What measures are being taken to ensure the safe and effective use of Rixathon?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rixathon?
English: An overview of Rixathon and why it is authorised in the EU
Danish: En oversigt over Rixathon, og hvorfor det er godkendt i EU
English: Why is Rixathon authorised in the EU?
Danish: Hvorfor er Rixathon godkendt i EU?
English: Side effects reported with Rixathon are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Rixathon vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The medicine is available for infusion (drip) into a vein.
Danish: Lægemidlet gives ved infusion (drop) i en vene.
English: In addition, Rixathon was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Rixathon or MabThera were added to other chemotherapy for part of the treatment.
Danish: Derudover var Rixathon lige så effektivt som MabThera i et hovedstudie, der omfattede 629 patienter med fremskredent ubehandlet follikulært lymfom, hvor Rixathon eller MabThera blev givet i tillæg til anden kemoterapi som en del af behandlingen.
English: In GPA and MPA, destroying B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Danish: Ved GPA og MPA fører ødelæggelsen af Bcellerne til nedsat dannelse af antistoffer, der menes at spille en vigtig rolle ved at angribe blodkarrene og forårsage inflammation.
English: The company marketing Rixathon will provide doctors with additional information about giving the medicine correctly.
Danish: Den virksomhed, der markedsfører Rixathon, vil udlevere supplerende oplysningsmateriale til læger om korrekt indgivelse af lægemidlet.
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Rixathon if they have severe heart problems.
Danish: Patienter med leddegigt, GPA, MPA eller pemphigus vulgaris må heller ikke få Rixathon, hvis de har alvorlige hjerteproblemer.
English: What is Rixathon and what is it used for?
Danish: Hvad er Rixathon, og hvad anvendes det til?
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a medicine to reduce fever).
Danish: Før hver infusion bør patienten gives et lægemiddel mod allergiske reaktioner (et antihistamin) og et febernedsættende lægemiddel (et antipyretikum).
English: Rixathon can only be obtained with a prescription.
Danish: Rixathon fås kun på recept.
English: Rixathon is a ‘biosimilar medicine'.
Danish: Rixathon er et "biosimilært" lægemiddel.
English: The most common side effects with Rixathon are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Danish: De hyppigste bivirkninger ved Rixathon er reaktioner i forbindelse med infusionen (f.eks. feber, kulderystelser og skælven), og de hyppigste alvorlige bivirkninger er infusionsrelaterede reaktioner, infektioner og hjerteproblemer.
English: The safety of Rixathon has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Danish: Sikkerheden ved Rixathon er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet MabThera.
English: The reference medicine for Rixathon is MabThera.
Danish: Referencelægemidlet for Rixathon er MabThera.
English: The active substance in Rixathon, rituximab, is a monoclonal antibody designed to attach to a protein called CD20, which is present on B cells.
Danish: Det aktive stof i Rixathon, rituximab, er et monoklonalt antistof, der er designet til at binde til proteinet CD20, som findes på overfladen af B-celler.
English: For more information about using Rixathon, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Rixathon, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Rixathon is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Danish: Rixathon er et lægemiddel til behandling af voksne med følgende former for blodkræft og betændelsesbetingede (inflammatoriske) sygdomme:
English: Rixathon contains the active substance rituximab.
Danish: Rixathon indeholder det aktive stof rituximab.
English: It will also provide doctors and patients using the medicine for rheumatoid arthritis, GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Danish: Den vil også udlevere oplysningsmateriale til læger og patienter, der anvender lægemidlet til behandling af leddegigt, GPA, MPA eller pemphigus, om risikoen for infektioner, herunder den sjældne alvorlige infektion progressiv multifokal leukoencefalopati (PML).
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Danish: • inflammatoriske sygdomme i blodkarrene (granulomatose med polyangiitis (GPA eller Wegeners granulomatose) og mikroskopisk polyangiitis (MPA))
English: What are the risks associated with Rixathon?
Danish: Hvilke risici er der forbundet med Rixathon?
English: Rixathon must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Danish: Rixathon må ikke anvendes til patienter, der er overfølsomme (allergiske) over for rituximab, museproteiner eller andre af indholdsstofferne eller til patienter med svær infektion eller alvorligt svækket immunsystem (kroppens naturlige forsvar).
English: Because Rixathon is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rixathon.
Danish: Da Rixathon er et biosimilært lægemiddel, behøver de studier af virkning og sikkerhed, der er udført for MabThera, ikke gentages for Rixathon.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rixathon has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Rixathon har en struktur, renhed og biologisk aktivitet, der svarer nøje til MabTheras, og at det fordeles i kroppen på samme måde.
English: All these data were considered sufficient to conclude that Rixathon will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Rixathon vil have de samme egenskaber som MabThera, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Rixathon outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Rixathon opvejer de identificerede risici som for MabThera, og at det kan godkendes til anvendelse i EU.
English: Laboratory studies comparing Rixathon with the reference medicine MabThera have shown that the active substance in Rixathon is highly similar to that in MabThera in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Rixathon med referencelægemidlet MabThera, har vist, at det aktive stof i Rixathon svarer nøje til MabThera, hvad angår struktur, renhed og biologisk aktivitet.
English: For the full list of side effects and restrictions of Rixathon, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rixathon fremgår af indlægssedlen.
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in rheumatoid arthritis and pemphigus (where B cells are involved in inflammation).
Danish: Dette hjælper ved lymfom og CLL (hvor B-celler er blevet til kræftceller) og ved leddegigt og pemphigus (hvor B-celler medvirker til inflammation).
English: Studies have also shown that giving Rixathon produces similar levels of the active substance in the body to giving MabThera.
Danish: Studier har også vist, at Rixathon giver samme mængde af det aktive stof i kroppen som MabThera.