natgillin/translations-raw huggingface dataset:
Med hensyn til tilbageholdelsestiden fremlagde indehaveren af markedsføringstilladelsen en tilfredsstillende restkoncentrationsundersøgelse hos svin.
With regard to the withdrawal period, a satisfactory residue depletion study in pigs was provided by the marketing authorisation holder.
Det blev beregnet, at en koncentration på 16,9 mg/l var den minimale dosis, der ville give den maksimale effekt.
It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Modstandsdygtighed over for lincomycin skyldes ofte plasmidbårne faktorer (erm-gener) med kodning for methylaser, der ændrer det ribosomale bindingssted og ofte fører til krydsresistens over for andre antimikrobielle stoffer i macrolid-, lincosamid- og streptogramingruppen.
Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm genes) coding for methylases modifying the ribosomal binding site and frequently leading to cross-resistance to other antimicrobials of the macrolides, lincosamides and streptogramins group.
Oral anvendelse (i drikkevand)
Oral use (via drinking water)
Behandlingen er symptomatisk.
There is no specific antidote, treatment is symptomatic.
Videnskabelige konklusioner og begrundelser for ændring af produktresuméet, etiketteringen og indlægssedlen
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Undlad at indgive samt give adgang til vand indeholdende lincomycin til kaniner, hamstre, marsvin, chinchillaer, heste eller drøvtyggere, eftersom det vil kunne medføre alvorlige gastrointestinale forstyrrelser.
Do not administer, and do not allow access to water containing lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.
Selv om der ikke er nogen standardiseret metode til bestemmelse af MIC for antibiotika mod B. hyodysenteriae, stod det med hensyn til in vitro-følsomhedsdataene klart, at størstedelen af isolaterne falder uden for den tilsyneladende vildtypepopulation.
With regard to the in vitro susceptibility data, although there is no standardised methodology for determination of the MIC for antibiotics against B. hyodysenteriae, it was evident that the majority of isolates fall outside the apparent wild-type population.
Ved tegn på åndedrætssymptomer efter eksponering søges lægehjælp og denne advarsel bør vises til lægen.
If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
Følsomheden af Mycoplasma hyopneumoniae over for antimikrobielle stoffer er vanskelig at teste in vitro som følge af tekniske begrænsninger.
The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Lægemidlets sikkerhed under drægtighed, laktation eller æglægning er ikke fastlagt for de dyrearter, som lægemidlet er beregnet til.
The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay in the target species.
In vitro-dataene fra offentliggjort litteratur og fra indehaveren af markedsføringstilladelsens egen undersøgelse viste, at MIC-fordelingen for lincomycin var bred og ikke unimodal.
The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MIC distribution for lincomycin was wide and not unimodal.
"Mycoplasma hyopneumoniaes følsomhed over for antimikrobielle stoffer er vanskelig at teste in vitro som følge af tekniske begrænsninger.
“The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Lincomycinhydrochlorid 470,6 mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)
470,6 mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)
Pakningsstørrelser: Flaske med 150 g Flaske med 1,5 kg
Bottle of 150 g Bottle of 1.5 kg
Hvor det er muligt, bør behandlingen være baseret på lokal epidemiologisk information (på regionalt niveau og bedriftsniveau) om responsen af enzootisk pneumoni/nekrotisk enteritis på behandling med lincomycin."
Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.”
Opbevaringstid efter første åbning af beholderen: anvendes straks.
Shelf life after first opening the container: use immediately.
Koncentrationen af lincomycin skal reguleres i henhold til dette for at opnå den rigtige dosis.
In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.
CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link
CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link procedure, the CVMP concluded that this indication should also be deleted from the product information for Lincocin.
Hvad angår indikationen for behandling og metafylakse af svinedysenteri forårsaget af Brachyspira hyodysenteriae og/eller andre bakterier, der er følsomme over for lincomycin, fremlagde indehaveren af markedsføringstilladelse data om minimale inhibitoriske koncentrationer (MIC) fra flere undersøgelser (herunder nylige interne undersøgelser foretaget i 2016), kliniske undersøgelser og undersøgelser fra den videnskabelige litteratur.
Concerning the indication for treatment and metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae and/or other bacteria susceptible to lincomycin, the marketing authorisation holder presented Minimum Inhibitory Concentration (MIC) data from several studies (including recent proprietary studies performed in 2016), clinical trials and studies from the scientific literature.
På baggrund af de tilgængelige data og i betragtning af variabiliteten i vandindtaget og dermed de behandlede dyrs dosis blev en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 dage foreslået.
preferable; based on the data available and taking into account the variability of water intake and hence the dose ingested by the treated animals, a dose rate of 5 mg lincomycin per kg of body weight for 7 days was proposed.
TEKSTEN ”KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Lincomycin indgår i det enterohepatiske kredsløb.
Lincomycin undergoes enterohepatic circulation.
Lincocin 40% Lincomycin (som lincomycinhydrochlorid)
Lincocin 40% Lincomycin (as lincomycin hydrochloride)
Det er påvist, at Lincocin er effektivt til behandling og metafylakse af enzootisk pneumoni forårsaget af M. hyopneumoniae hos svin.
Lincocin has been shown to be efficacious for the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae in pigs.
De fremlagte kliniske data viste, at Lincocin var effektivt til behandling og metafylakse af nekrotisk enteritis forårsaget af C. perfringens i en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 på hinanden følgende dage.
The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens at a dose rate of 5 mg lincomycin per kg of body weight for 7 consecutive days.
De fremlagte kliniske data viste, at Lincocin var effektivt til behandling og metafylakse af enzootisk pneumoni forårsaget af M. hyopneumoniae, når det blev administreret i en dosis på 10 mg lincomycin pr. kg kropsvægt i 21 på hinanden følgende dage.
The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae when administered at 10 mg lincomycin per kg of body weight for 21 consecutive days.
In vitro-dataene fra offentliggjort litteratur og fra indehaveren af markedsføringstilladelsens egen undersøgelse viste, at MIC-værdierne for lincomycin var brede og ikke var unimodale.
The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MICs for lincomycin had wide ranges and were not unimodal.
Må ikke anvendes i tilfælde nedsat leverfunktion.
Do not use in cases of hepatic dysfunction.
Må ikke blandes med lægemidler til dyr.
Do not mix with any other veterinary medicinal product
Det er ligeledes dokumenteret, at Lincocin er effektivt til behandling og metafylakse af nekrotisk enteritis forårsaget af C. perfringens hos kyllinger.
Lincocin has also been proven to be efficacious in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens in chickens.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Behandlingen bør så vidt muligt baseres på lokale epidemiologiske oplysninger (på regionalt niveau, for det enkelte landbrug) om, hvordan enzootisk pneumoni/nekrotisk enteritis reagerer på behandling med lincomycin.
Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.
CVMP anerkendte, at det var vanskeligt at fastlægge en enkelt dosis og fastslog, at forslaget om en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 dage var acceptabelt, selv om dosis var en smule vilkårligt valgt.
The CVMP acknowledged the difficulties in determining a single dose and agreed that although somewhat arbitrarily selected, the proposal for a dose rate of 5 mg lincomycin per kg of body weight for 7 days is acceptable.
6.4 Særlige opbevaringsforhold
SPECIAL STORAGE CONDITIONS
Silica, vandfri, kolloid Laktosemonohydrat
Colloidal anhydrous silica Lactose monohydrate
• indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen
• the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Det dobbelte dosisinterval uden en klar vejledning til slutbrugeren om, hvornår lægemidlet skal administreres i henholdsvis den højeste og den laveste dosis, blev dog anset for at være uklart.
It seemed to be in line with the posology assessed in the studies provided; however, the two-fold dose range with no clear guidance for the end-user as to when to administer the product at either the higher or lower limit of the range was considered to be ambiguous.
Til støtte for indikationen for behandling og metafylakse af enzootisk pneumoni forårsaget af Mycoplasma hyopneumoniae fremlagde indehaveren af markedsføringstilladelsen in vitrofølsomhedsdata, herunder en nylig intern undersøgelse, og kliniske data, herunder feltundersøgelser.
In support of the indication for treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae the marketing authorisation holder provided in vitro susceptibility data, including a recent proprietary study, and clinical data, including field studies.
Svin og kyllinger
Pigs and chickens
Der foreligger ældre undersøgelser foretaget med mikrobiologiske metoder, og de viser, at en tilbageholdelsestid på nul dage kunne være passende.
Older studies, using microbiological methods, are available and indicate that a zero-day withdrawal period could be appropriate; however, these studies are not considered to have been conducted to current standards.
Ved gennemtrængning af tarmvæggen fordeles lincomycin i vidt omfang til alt væv, især lunger og ledhuler.
Crossing the intestinal barrier, lincomycin is widely distributed to all tissues, especially the lungs and joint cavities; the volume of distribution is about 1 litre.
MARKEDSFØRINGSTILLADELSES NUMMER (NUMRE) Udfyldes nationalt.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Zoetis Hungary Kft.
Hungary Zoetis Hungary Kft. Budapest, Alkotás u.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hvert g indeholder:
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Behandling og metafylakse af enzootisk pneumoni forårsaget af Mycoplasma hyopneumoniae.
Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Behandling og metafylakse af nekrotisk enteritis forårsaget af Clostridium perfringens.
Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Svin, Fjerkræ (slagtekyllinger)
Pigs, poultry (broilers)
Begrundelser for ændring af produktresuméet, etiketteringen og indlægssedlen
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
De pågældende undersøgelser blev dog foretaget i perioden 1977-1993, og MIC for isolaterne blev ikke bestemt i størstedelen af de fremlagte kliniske undersøgelser.
The clinical data provided indicated that Lincocin was effective for the treatment of swine dysentery caused by B. hyodysenteriae; however, the studies in question were conducted in the period 1977-1993 and the MICs of isolates were not determined in the majority of clinical studies submitted.
Enzootisk pneumoni: 10 mg lincomycin pr. kg kropsvægt (svarende til 25 mg af lægemidlet pr. kg kropsvægt) i 21 på hinanden følgende dage.
Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days.
Nekrotisk enteritis: 5 mg lincomycin pr. kg kropsvægt (svarende til 12,5 mg af lægemidlet pr. kg kropsvægt) i 7 på hinanden følgende dage.
Necrotic enteritis: 5 mg lincomycin per kg of body weight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days.
DYREARTER Svin og kyllinger.
TARGET SPECIES Pigs and chickens.
• CVMP har gennemgået produktresuméet, etiketteringen og indlægssedlen som forelagt af indehaveren af markedsføringstilladelsen og taget alle de indsendte data i betragtning anbefalede CVMP ændringen af markedsføringstilladelserne for Lincocin og relaterede navne, jf. bilag I. Produktresumé, etikettering og indlægsseddel for disse fremgår af bilag III.
the CVMP has recommended the amendment of the marketing authorisations for Lincocin and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
2 dage efter behandlingens afslutning var restkoncentrationerne i lever, nyrer og muskler alle under MRL. Én sammensat muskelprøve ud af tre havde restkoncentrationer, der lå en smule over MRL (57 µg/kg i forhold til 50 µg/kg).
One composite muscle sample out of three had residues slightly above the MRL (57 µg/kg versus 50 µg/kg).
INDIKATION(ER) Læs indlægssedlen inden brug.
Read the package leaflet before use.
Pulver til anvendelse i drikkevand
powder for use in drinking water
VETERINÆRLÆGEMIDLETS NAVN Lincocin 400 mg/g pulver til brug i drikkevand.
NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin 400 mg/g powder for use in drinking water.
• Måldyrearter
• Target species
− Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Lincomycin (som lincomycinhydrochlorid) 400 mg
Each g contains: Lincomycin (as lincomycin hydrochloride) 400 mg
Til anvendelse i drikkevand
In drinking water use
Derfor bør brugen af lægemidlet ikke tillades til æglæggende fugle, som producerer æg til menneskeligt konsum.
Not authorised for use in laying birds producing eggs for human consumption.
Til behandling og metafylakse (”gruppebehandling”) af nekrotisk enteritis forårsaget af Clostridium perfringens.
For the treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Lægemiddelform Dyrearter
Animal species
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Begge kan forårsage allergiske reaktioner hos nogle personer.
This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people.
Der kan forekomme antagonisme mellem lincomycin og macrolider som f.eks. erythromycin og andre bakteriedræbende antibiotika.
Antagonism may exist between lincomycin and macrolides such as erythromycin and other bactericidal antibiotics; concurrent use is therefore not recommended due to competitive binding at the 50S ribosomal subunit of the bacterial cell.
INDLÆGSSEDDEL Lincocin 400 mg/g pulver til brug i drikkevand
PACKAGE LEAFLET: Lincocin 400 mg/g powder for use in drinking water
VETERINÆRLÆGEMIDLETS NAVN Lincocin 400 mg/g pulver til opløsning i drikkevand
NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin 400 mg/g powder for use in drinking water
ANGIVELSE AF AKTIVE STOFFER Hvert gram indeholder 400 mg lincomycin (som lincomycinhydrochlorid).
Lincocin 400 mg/g powder for use in drinking water Lincomycin (as lincomycin hydrochloride) STATEMENT OF ACTIVE SUBSTANCES Each g contains 400 mg lincomycin (as lincomycin hydrochloride).
Med hensyn til æglæggende høns er der ingen data til støtte for en tilbageholdelsestid for æg.
Regarding laying hens, there are no data to support a withdrawal period in eggs; hence, the use of the product should not be authorised in laying birds producing eggs for human consumption.
− Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Oral til anvendelse i drikkevand
Oral via the drinking water
Indehaver af markedsføringstilladelsen: Udfyldes nationalt.
Manufacturer responsible for batch release: To be completed nationally
Indehaveren af markedsføringstilladelsen fremlagde in vitro-følsomhedsdata, herunder en nylig intern undersøgelse fra 2016, kliniske undersøgelser og data fra den videnskabelige litteratur, til støtte for den foreslåede harmoniserede indikation for behandling og metafylakse af nekrotisk enteritis forårsaget af Clostridium perfringens.
To support the proposed harmonised indication for treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens, the marketing authorisation holder presented in vitro susceptibility data including a recent proprietary study from 2016, clinical studies and data from the scientific literature.
Svin, kyllinger Oral
Pigs, chickens
Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr: Produktet indeholder lincomycin og laktosemonohydrat.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Medlemsstaternes gennemførelse af standpunktet:
Implementation of the position by the Member States:
26. juli 2019
26 July 2019
26. juni 2019
26 June 2019
Vedtagelse af CMDh's standpunkt ved konsensus: CMDh-mødet i maj 2019 Oversættelser af bilagene for indstillingen fremsendes til de nationale kompetente myndigheder:
Transmission to National Competent Authorities of the translations of the annexes to the position:
Sjælden (forekommer hos færre end 1 ud af 1.000 patienter)
Rare (affects less than 1 in 1,000 people)
Punkt 4.4
Section 4.4
Vedtaget af PRAC d. 14.-17. marts 2016
Adopted at the 14-17 March 2016 PRAC
Den øgede risiko synes at være relateret til behandlingens intensitet og varighed.
The increased risk appears to be related to the degree and duration of immunosuppression.
Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger om signaler
New product information wording - Extracts from PRAC recommendations on signals
Axitinib skal seponeres, hvis patienten udvikler nefrotisk syndrom.
Axitinib should be discontinued if the patient develops nephrotic syndrome.
Bivirkninger, hvis hyppighed ikke kendes (kan ikke beregnes ud fra forhåndenværende data):
Not known side effects are (frequency cannot be estimated from the available data):
• Lavt indhold af fibrinogen i blodet (et protein, der medvirker til blodets størkning)
• Low fibrinogen levels in the blood (a protein involved in blood clotting)
• tumorer, herunder hudkræft.
• tumours, including skin cancer.
Indlægsseddel: Det er ikke nødvendigt at foretage ændringer i indlægssedlen.
Package Leaflet (PL) No changes to the PL are needed.
Mutagenicitet og karcinogenicitet
Mutagenicity and carcinogenicity/Carcinogenicity
Punkt 4.8 Bivirkninger
4.8 Undesirable effects
• forskellige former for kræft, herunder blodkræft, lymfekræft og hudkræft
• various types of cancers including blood, lymph and skin cancers
Når <De> <du> tager {X}, skal <De> <du> derfor undgå for megen eksponering for sollys, og <De> <du> skal bruge beskyttende påklædning og solcreme med en høj beskyttelsesfaktor.
Therefore, when taking <X>, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
Behandling med {X} kan medføre en øget risiko for:
Taking <X> could put you at greater risk of:
Det anbefales at monitorere for proteinuri før og regelmæssigt under behandlingen med axitinib.
Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended.
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data): hypofibrinogenæmi
Frequency not known (cannot be estimated from the available data): hypofibrinogenaemia
Det er rapporteret, at seponering af den immunsupprimerende behandling kan medføre partiel regression af den lymfoproliferative sygdom.
It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder.
Hvis MAS opstår eller mistænkes, skal evaluering og behandling startes så hurtigt som muligt, og mercaptopurin skal seponeres.
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with mercaptopurine should be discontinued.
• lymfoproliferative sygdomme o behandling med {X} øger risikoen for at få en type kræft, der kaldes "lymfoproliferativ sygdom".
• lymphoproliferative disorders o treatment with <X> increases your risk of getting a type of cancer called lymphoproliferative disorder.
Hvis MAS opstår eller mistænkes, skal evaluering og behandling startes så hurtigt som muligt, og azathioprin skal seponeres.
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued.
Ved behandlingsregimer, der består af flere immunsupprimerende lægemidler, herunder thiopuriner, kan dette medføre dødsfald.
With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death.
Hos patienter, der udvikler moderat til svær proteinuri, skal dosis reduceres eller behandlingen afbrydes midlertidigt (se pkt.
For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment (see section 4.2).
Læger skal være opmærksomme på symptomer på infektion forårsaget af f.eks. Epstein-Barr-virus (EBV) og cytomegalovirus (CMV), da disse kan udløse MAS.
Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.