FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, based on the activity spectrum of the combination, on general considerations of the pathogenesis of porcine proliferative enteropathy and on the available clinical data, it is considered that the indication for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by L. intracellularis, and associated enteric pathogens (E. coli) at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days in drinking water, approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, is justified.
Danish: Aktivitetsspektret for kombinationen og generelle betragtninger om patogenesen af porcin proliferativ enteropati og de foreliggende ikke-kliniske data giver derfor grundlag for indikationen behandling og forebyggelse af porcin proliferativ enteropati (ileitis) forårsaget af L. intracellularis og tilhørende enteropatogener (E. coli) ved en dosis på 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage i drikkevand, som godkendt under artikel 34-indbringelsesproceduren (EMEA/V/A/088) for Linco-Spectin 100.
English: Lincomycin-Spectinomycin Pulver
Danish: LincomycinSpectinomycin Pulver
English: 24192 León Spain
Danish: León-Vilecha, 30 24192 León
English: Germany Bela-Pharm GmbH & Co.KG
Danish: Tyskland Bela-Pharm GmbH & Co.KG Lohner Str. 19
English: Kepro B.V. Maagdenburgstraat
Danish: Maagdenburgstraat 17
English: Only one study with premixes for medicated feeding stuff containing the combination lincomycinspectinomycin against swine dysentery was submitted.
Danish: Der er kun forelagt én undersøgelse med kombinationen lincomycin-spectinomycin som premix til foderlægemiddel mod svinedysenteri.
English: Zone D'Activites Du Bois De Teillay 35150 Janze France
Danish: Zone D'Activites Du Bois De Teillay
English: Concerning powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw (10 mg combined actives/kg bw) per day for 7 days is considered effective in cases of porcine proliferative enteropathy caused by L. intracellularis, and possible associated pathogens among which is E. coli.
Danish: For pulver til opløsning i drikkevand anses en kombination af lincomycin og spectinomycin til svin i en dosis af 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt (10 mg kombinerede aktive stoffer/kg kropsvægt) pr. dag i 7 dage for at være effektiv ved porcin proliferativ enteropati forårsaget af L. intracellularis og eventuelle tilknyttede patogener, heriblandt E. coli.
English: Therefore, although overall the combination of lincomycin and spectinomycin showed to be clinically effective against E. coli in chickens, appropriate sentence should be included in SPC section 5.1 Pharmacodynamic properties to reflect the lack of absorption of spectinomycin in the gut.
Danish: Skønt kombinationen lincomycin-spectinomycin overordnet er påvist at være klinisk effektivt mod E. coli hos kyllinger, bør der derfor i produktresuméets pkt.
English: LINCOTRIMEX-PREMIX Lincomycin and Spectinomycin
Danish: LINCOTRIMEX-PREMIX Lincomycin og spectinomycin
English: Germany Zoetis Deutschland GmbH
Danish: Tyskland Zoetis Deutschland GmbH Schellingstrasse 1
English: In Campylobacter, variable but possibly high resistance rates were shown against lincomycin; however the situation could be more complex because those bacteria are also considered susceptible to spectinomycin, for which few data are available.
Danish: Der kan dog være tale om en mere kompleks situation, da disse bakterier desuden anses for at være følsomme for spectinomycin, hvilket der kun foreligger få data om.
English: In chickens, powders for use in drinking water containing a combination of lincomycin and spectinomycin at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days is considered effective in cases of CRD caused by M. gallisepticum and E. coli, and associated with a low mortality rate.
Danish: Hos kyllinger anses pulver til opløsning i drikkevand indeholdende en kombination af lincomycin og spectinomycin i en dosis af 16,65 mg lincomycin og 33,35 mg spectinomycin/kg kropsvægt (50 mg kombinerede aktive stoffer /kg kropsvægt) pr, dag i syv dage for at være effektiv ved luftvejssygdomme, der er forårsaget af M. gallisepticum og E. coli og har lav dødelighed.
English: Lincomycin-spectinomycin VMD Pulvis
Danish: Lincomycinspectinomycin VMD Pulvis
English: Pigs, poultry
Danish: Svin, fjerkræ
English: No appropriate efficacy data or no data at all have been presented regarding the other indications currently approved for the group of products under assessment.
Danish: For de øvrige aktuelt godkendte indikationer for den vurderede produktgruppe er data vedrørende virkning utilstrækkelige eller mangler helt.
English: 2.2 % w/w 2.2 % w/w
Danish: Linco-Spectin Premix for Medicated Feed w/w 2.2 % w/w
English: This study showed that, overall, the lincomycin-spectinomycin combination significantly improved the tested clinical, pathological and bacteriological endpoints in an experimental model of aerosol infection, at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days.
Danish: Undersøgelsen viste, at kombinationen lincomycinspectinomycin i en forsøgsmodel med aerosolinfektion medførte væsentlig overordnet bedring i de testede kliniske, patologiske og bakteriologiske endepunkter ved en dosis på 16,65 mg lincomycin og
English: Pigs, hens pigeons, ducks, turkeys
Danish: Svin, høns duer, ænder, kalkuner
English: Ramsgate Road Sandwich, Kent CT13 9NJ
Danish: CT13 9NJ
English: Lithuania Bela-Pharm GmbH & Co.KG
Danish: Bela-Pharm GmbH & Co.KG Lohner Str. 19
English: Podružnica Zagreb za promidžbu Petra Hektorovića 2 10000 Zagreb Croatia
Danish: Podružnica Zagreb za promidžbu
English: Most available clinical efficacy data relate to administration of the combination as powder for use in drinking water; those from the basis for the harmonised dosing regimen of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days for Linco-Spectin 100, as approved during the Article 34 referral procedure (EMEA/V/A/088).
Danish: Disse data danner grundlag for det harmoniserede dosisregime på 3,33 mg lincomycin og 6,67 mg spectinomycin/kg kropsvægt/dag i 7 dage for Linco-Spectin 100, som er godkendt under artikel 34-indbringelsesproceduren (EMEA/V/A/088).
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Danish: Spectinomycin er et antibiotikum i aminocyclitolgruppen og udvindes fra Streptomyces spectabilis.
English: Furthermore the CVMP recommended variations of the marketing authorisations for powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or chickens (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Danish: Desuden anbefalede CVMP ændring af markedsføringstilladelserne for pulver til anvendelse i drikkevand indeholdende en kombination af lincomycin og spectinomycin til svin og og/eller kyllinger (se bilag I) med Veterinærlægemidler indeholdende en kombination af lincomycin og spectinomycin
English: Pigs, chickens (broilers)
Danish: Svin, kyllinger (slagtekyllinger)
English: Linko-spectin 44 premix Lincomycin and Spectinomycin
Danish: Linko-spectin 44 premix Lincomycin og spectinomycin
English: Belgium Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Rumænien Zoetis Belgium SA Rue Laid Burniat, 1
English: Piglets, calves, chickens
Danish: Smågrise, kalve, kyllinger
English: Lithuania Zoetis Belgium SA Rue Laid Burniat, 1
Danish: Slovenien Zoetis Belgium SA Rue Laid Burniat, 1
English: 33,35 g/100 g
Danish: 5,5 g/kg 5,5 g/kg
English: Linco-Spectin 44 Premix Lincomycin and Spectinomycin
Danish: Linco-Spectin 44 Premix Lincomycin og spectinomycin
English: Pigs, chickens
Danish: Svin, Kyllinger
English: Lismay Premix, Prémistura medicamentosa para alimento medicamentoso
Danish: Lismay Premix, Prémistura medicamentosa para alimento medicamentoso g/1.5 kg g/1.5 kg
English: Linco-Spectin SP 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Danish: Linco-Spectin SP 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens w/w w/w
English: 33,3 g/150 g 66,6 g/150 g
Danish: g/1.5 kg g/1.5 kg
English: 4.11 Withdrawal period(s)
Danish: Når følgende måldyrearter i forvejen er godkendt, gælder nedenstående tilbageholdelsestider: 4.11 Tilbageholdelsestid
English: Calves, piglets, chickens
Danish: Kalve, svin, kyllinger
English: Lohner Str. 19
Danish: Stroupežnického 17
English: Very limited data or no data were provided to support the use of premixes for medicated feeding stuff and oral powders to be administered with the feed containing lincomycin and spectinomycin.
Danish: For anvendelse af premix til foderlægemiddel og oralt pulver til administration i foderet indeholdende lincomycin og spectinomycin er data meget begrænsede eller mangler helt.
English: Pigs, poultry (broiler, pullet) and turkey
Danish: Svin, fjerkræ (slagtekyllinger, hønekyllinger), kalkuner
English: Schellingstrasse 1
Danish: Ramsgate Road
English: # median (min-max)
Danish: # median (min-maks)
English: Updated analysis from CIBMTR to be submitted by end of December 2020.
Danish: Opdateret analyse fra CIBMTR skal indsendes i slutningen af december 2010.
English: The mechanism of action is multifactorial.
Danish: Virkningsmekanismen er multifaktoriel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/878/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/878/001
English: Almost all renal excretion occurs within the first 4 hours.
Danish: Næsten hele nyreudskillelsen sker i løbet af de første 4 timer.
English: You will receive this treatment four times a day for at least 21 days or until your symptoms resolve.
Danish: Du vil få denne behandling fire gange dagligt i mindst 21 dage, eller indtil dine symptomer svinder.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis indsendelsen af en PSUR og opdateringen af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: However, the clinical relevance of these findings is unknown.
Danish: Den kliniske relevans af disse fund kendes dog ikke.
English: Only clear solutions without visible particles should be used.
Danish: Der må kun anvendes klare opløsninger uden synlige partikler.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer registreres tydeligt i patientjournalen.
English: Summary of the Safety Profile
Danish: Sammenfatning af sikkerhedsprofilen
English: At an interim analysis of the on-going registry, data from 96 patients with severe VOD were available.
Danish: Ved en interimanalyse af den igangværende registrering forelå der data fra 96 patienter med svær VOD.
English: US Registry data
Danish: Amerikanske registerdata
English: This can be caused by medicines that are given prior to a stem cell transplantation.
Danish: Sygdommen kan forårsages af de lægemidler, der gives før en stamcelletransplantation.
English: Individual Studies
Danish: De enkelte undersøgelser
English: Data derived from an independent US registry have shown a beneficial effect of Defitelio in routine clinical practice.
Danish: Data fra et uafhængigt amerikansk register har vist gavnlig virkning af Defitelio ved rutinemæssig anvendelse i klinisk praksis.
English: • if you are taking medicine that increases the risk of bleeding
Danish: • hvis du tager medicin, som øger risikoen for blødning
English: It will be slowly injected (over a 2-hour period) into one of your veins.
Danish: Lægemidlet vil blive injiceret langsomt (i løbet af to timer) i en af dine vener.
English: There is no specific antidote for overdose and treatment should be symptomatic.
Danish: Der er ingen specifik antidot mod en overdosis, og behandlingen er symptomatisk.
English: However, the exact mechanism of action of defibrotide is not fully elucidated.
Danish: Den nøjagtige virkningsmekanisme for defibrotid er imidlertid ikke fuldt opklaret.
English: • if you have problems with blood circulation because your body cannot maintain a constant blood pressure.
Danish: • hvis du har problemer med kredsløbet, fordi din krop har svært ved at holde blodtrykket konstant.
English: • if you have heavy bleeding and need a blood transfusion
Danish: • hvis du bløder kraftigt og har behov for blodtransfusion
English: * produced from porcine intestinal mucosa.
Danish: * produceret af tarmmucosa fra svin.
English: • if you are undergoing surgery
Danish: • hvis du får foretaget en operation
English: Volume of distribution is around 10 L. In vitro studies demonstrate that 93% of Defitelio is bound to plasma proteins.
Danish: Fordelingsvoluminet er ca. 10 l. In vitro-studier viser, at 93 % af Defitelio binder til plasmaproteiner.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Danish: Hyppighed inddeles på følgende måde: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: Side effects in children (1 month to 18 years old) are expected to be similar in type, severity and frequency and no other special precautions are needed.
Danish: Bivirkningerne hos børn (fra 1 måned til 18 år) forventes at være af samme type, sværhed og hyppighed som hos voksne, og der kræves ingen andre særlige forsigtighedsregler.
English: Safety information in children are available from the prevention study conducted solely in children.
Danish: Oplysninger om sikkerheden hos børn fremgår af forebyggelsesundersøgelsen, der udelukkende blev udført hos børn.
English: • Data analysis from CIBMTR for patients treated and not treated with defibrotide
Danish: • Dataanalysen fra CIBMTR for patienter, der er behandlet og ikke behandlet med defibrotid
English: Considering the nature of the medicinal product, a risk to the newborns/infants is not expected.
Danish: I betragtning af lægemidlets art forventes der ikke at være risiko for nyfødte/spædbørn.
English: However there was no difference in incidence of serious bleeding or bleeding events with fatal outcome.
Danish: Der var imidlertid ingen forskel i forekomsten af alvorlige blødninger eller blødningshændelser med fatalt udfald.
English: The recommended dose in children from one month to 18 years of age is the same as in adults.
Danish: Den anbefalede dosis til børn fra en måned til 18 år er den samme som til voksne.
English: Adverse reactions observed are listed below, by system organ class and frequency.
Danish: De iagttagne bivirkninger er nedenfor opstillet efter systemorganklasse og hyppighed.
English: It is administered by intravenous infusion, over two hours.
Danish: Det administreres ved intravenøs infusion i løbet af to timer.
English: This is called an ‘intravenous infusion' or drip.
Danish: Dette kaldes “intravenøs infusion” eller drop.
English: Macrophages are considered the main target organ.
Danish: Makrofager anses for at være det vigtigste målorgan.
English: PAI-2 is known to be uniquely up-regulated in the placenta.
Danish: PAI-2 vides at blive entydigt opreguleret i placenta.
English: Measure 1
Danish: Foranstaltning 1
English: *=Kaplan Meier estimates for time-to-event analysis by Day100
Danish: *=Kaplan Meier-estimater for analyse af tid-til-hændelse på dag +100
English: The treatment should be administered for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve.
Danish: Behandlingen bør administreres i mindst 21 dage og fortsætte, indtil symptomerne og tegnene på svær VOD svinder.
English: If you are sexually active and you or your partner could become pregnant, you both must use effective contraception during treatment with Defitelio and for 1 week after stopping the treatment.
Danish: Hvis du er seksuelt aktiv, og du eller din partner kan blive gravid, skal I begge bruge effektiv prævention under behandlingen med Defitelio og en uge efter at være ophørt med behandlingen.
English: Preparation of Defitelio (use aseptic technique):
Danish: Klargøring af Defitelio (brug aseptisk teknik):
English: Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development.
Danish: På grund af denne maternelle toksicitet kan der ikke drages konklusioner om virkningerne af defibrotid på den embryoføtale udvikling.
English: The report will also reflect on the safety data being collected during prophylactic treatment, and any potential safety differences related to the difference in indication (ie treatment vs prophylactic therapy).
Danish: Rapporten vil desuden omhandle de sikkerhedsdata, der indsamles under profylaktisk behandling, samt eventuelle potentielle sikkerhedsmæssige forskelle i relation til forskellen i indikation (dvs. behandling vs. profylaktisk behandling).
English: You must not be given a double dose to make up for a missed dose.
Danish: Du må ikke få en dobbeltdosis som erstatning for en glemt dosis.
English: These data are from an open label registry and the subjects were not randomised.
Danish: Disse data er fra et åbent register, og patienterne blev ikke randomiseret.
English: The treatment with Defitelio can be initiated and continuously supervised only by an experienced doctor in a hospital or in a specialised centre for stem cells transplantation.
Danish: Behandlingen med Defitelio kan kun iværksættes og løbende overvåges af en erfaren læge på et hospital eller på et specialcenter for stamcelletransplantation.
English: If particles are observed and/or the liquid in the vial is not clear, the vial must not be used.
Danish: Hvis der iagttages partikler, og/eller hvis væsken i hætteglasset ikke er klar, må hætteglasset ikke anvendes.
English: Defitelio might be considered free of proarrhythmic toxicity related to QT changes.
Danish: Defitelio kan anses for at være fri for proarytmisk toksicitet forbundet med QT-forandringer.
English: In the treatment studies over 50% of the patients were children.
Danish: I behandlingsundersøgelserne udgjorde børn mere end 50 % af patienterne.
English: Date of latest renewal: 26 July 2018
Danish: Dato for første markedsføringstilladelse: 18. oktober 2013 Dato for seneste fornyelse: 26. juli 2018
English: OTHER 200 mg/2.5 mL Gentium Srl
Danish: ANDET 200 mg/2.5 mL Gentium Srl
English: In each of the clinical trials performed in the treatment of VOD, over 50% of patients were under the age of 18 years.
Danish: I hvert af de kliniske forsøg med behandling af VOD var mere end 50 % af patienterne under 18 år.
English: Defitelio is a medicine that contains the active substance defibrotide.
Danish: Defitelio er et lægemiddel, der indeholder det aktive stof defibrotid.
English: Median length of therapy in those treated with Defitelio was 22 days.
Danish: Den mediane behandlingsvarighed for patienter behandlet med Defitelio var 22 dage.
English: End of February
Danish: Slutningen af februar 2021
English: A controlled randomised prophylaxis study (Study 2004-000592-33) was conducted in the paediatric patients undergoing HSCT.
Danish: Der blev gennemført en kontrolleret, randomiseret forebyggelsesundersøgelse (2004-000592-33) hos pædiatriske patienter, der fik foretaget HSCT.
English: Cmax (µg/mL) tmax (h)# AUCt (µg/mL*h) AUC (µg/mL*h) Vd (mL) CL (L/h) Kel (1/h) t1/2 (h)
Danish: Cmax [µg/ml] tmax (t)# AUCt (µg/ml*t) AUC (µg/ml*t) Vd (ml) CL (l/t) Kel (1/t) t1/2 (t)
English: Survival by Day+100
Danish: Overlevelse på dag+100
English: Table 1: Treatment Study Results: Complete Response and Survival Rate of Severe VOD at Day+100
Danish: Resultater af behandlingsundersøgelsen: komplet respons og overlevelsesrate af svær VOD på dag +100
English: Historical Control
Danish: Historisk kontrolgruppe
English: The safety data from the pivotal study are supported and confirmed with data from the completed Treatment-IND study.
Danish: Sikkerhedsdataene fra pivotalstudiet er underbyggede og bekræftede med data fra det fuldførte Treatment-IND-studie.
English: Pharmacotherapeutic group: other antithrombotic agents; ATC code: B01AX01.
Danish: Farmakoterapeutisk klassifikation: Andre antitrombotiske midler, ATC-kode: B01AX01.
English: The frequency nature and severity of adverse reactions in children are otherwise the same as in adults.
Danish: Hos børn er hyppighed, art og sværhed af alvorlige reaktioner i øvrigt den samme som hos voksne.
English: Coppell et al in 2010 reported data from a large meta-analysis of 235 patients with severe VOD showing a background mortality rate of severe VOD of 84.3% and that this mortality rate has remained constant over several decades.
Danish: Coppell et al rapporterede i 2010 data fra en stor metaanalyse af 235 patienter med svær VOD, der viste, at baggrundsmortaliteten ved svær VOD er 84,3 % og har været konstant gennem flere årtier.
English: Maximum plasma concentrations peaked at the end of the infusion period and declined thereafter with a rapid clearance and most of samples were undetectable 3.5 hours after the start of the infusion.
Danish: Plasmakoncentrationerne nåede deres maksimum ved slutningen af infusionsperioden og aftog derefter med høj clearance og var i størstedelen af prøverne ikke-detektérbare 3,5 timer efter påbegyndelse af infusionen.
English: Patients (n=356) were randomised to receive 25 mg/kg/day from the start of conditioning or were randomised to receive no prophylaxis.
Danish: Patienterne (n=356) blev randomiseret til enten at få 25 mg/kg hver dag fra begyndelsen af konditioneringen eller ingen forebyggende behandling.
English: • if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for defibrotid eller et af de øvrige indholdsstoffer i Defitelio (angivet i afsnit 6)
English: Do not use Defitelio
Danish: Brug ikke Defitelio
English: Defitelio should always be diluted prior to use.
Danish: Defitelio skal altid fortyndes før brug.
English: • coagulopathy (disturbance of blood clotting)
Danish: • koagulopati (forstyrrelser i blodets størkning)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller karcinogenicitet.
English: Additional information is shown in the following Table 2.
Danish: Nedenstående tabel 2 indeholder nærmere oplysninger:
English: Like all medicines, Defitelio can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Talk to your doctor before using Defitelio:
Danish: Kontakt lægen, før du bruger Defitelio:
English: It is not known whether defibrotide is excreted in human milk.
Danish: Det er ukendt, om defibrotid udskilles i human mælk.
English: • severe allergic reaction (you might experience swelling of the hands, face, lips, tongue or throat,
Danish: • svær allergisk reaktion (f.eks. hævede hænder, ansigt, læber, tunge og hals, vejrtrækningsbesvær).
English: Defitelio should not be used during pregnancy unless the clinical condition of the woman requires treatment with Defitelio.
Danish: Defitelio bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med Defitelio.
English: The concentrate solution for infusion has to be diluted using aseptic technique.
Danish: Den koncentrerede infusionsvæske skal fortyndes med anvendelse af aseptisk teknik.