FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Pigs and chickens
Danish: Svin og kyllinger
English: 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.
Danish: Der foreligger ældre undersøgelser foretaget med mikrobiologiske metoder, og de viser, at en tilbageholdelsestid på nul dage kunne være passende.
English: 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.
Danish: Ved gennemtrængning af tarmvæggen fordeles lincomycin i vidt omfang til alt væv, især lunger og ledhuler.
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Danish: MARKEDSFØRINGSTILLADELSES NUMMER (NUMRE) Udfyldes nationalt.
English: Hungary Zoetis Hungary Kft. Budapest, Alkotás u.
Danish: Zoetis Hungary Kft.
English: Cherrywood Business Park
Danish: Cherrywood Business Park Loughlinstown Co. Dublin Ireland
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hvert g indeholder:
English: Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Danish: Behandling og metafylakse af enzootisk pneumoni forårsaget af Mycoplasma hyopneumoniae.
English: Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Danish: Behandling og metafylakse af nekrotisk enteritis forårsaget af Clostridium perfringens.
English: Pigs, poultry (broilers)
Danish: Svin, Fjerkræ (slagtekyllinger)
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Begrundelser for ændring af produktresuméet, etiketteringen og indlægssedlen
English: 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.
Danish: De pågældende undersøgelser blev dog foretaget i perioden 1977-1993, og MIC for isolaterne blev ikke bestemt i størstedelen af de fremlagte kliniske undersøgelser.
English: Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days.
Danish: Enzootisk pneumoni: 10 mg lincomycin pr. kg kropsvægt (svarende til 25 mg af lægemidlet pr. kg kropsvægt) i 21 på hinanden følgende dage.
English: Necrotic enteritis: 5 mg lincomycin per kg of body weight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days.
Danish: Nekrotisk enteritis: 5 mg lincomycin pr. kg kropsvægt (svarende til 12,5 mg af lægemidlet pr. kg kropsvægt) i 7 på hinanden følgende dage.
English: TARGET SPECIES Pigs and chickens.
Danish: DYREARTER Svin og kyllinger.
English: 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.
Danish: • 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.
English: One composite muscle sample out of three had residues slightly above the MRL (57 µg/kg versus 50 µg/kg).
Danish: 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).
English: Read the package leaflet before use.
Danish: INDIKATION(ER) Læs indlægssedlen inden brug.
English: powder for use in drinking water
Danish: Pulver til anvendelse i drikkevand
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin 400 mg/g powder for use in drinking water.
Danish: VETERINÆRLÆGEMIDLETS NAVN Lincocin 400 mg/g pulver til brug i drikkevand.
English: Pharmacokinetic particulars
Danish: Farmakokinetiske oplysninger
English: • Target species
Danish: • Måldyrearter
English: 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).
Danish: − Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
English: Each g contains: Lincomycin (as lincomycin hydrochloride) 400 mg
Danish: Lincomycin (som lincomycinhydrochlorid) 400 mg
English: In drinking water use
Danish: Til anvendelse i drikkevand
English: Not authorised for use in laying birds producing eggs for human consumption.
Danish: Derfor bør brugen af lægemidlet ikke tillades til æglæggende fugle, som producerer æg til menneskeligt konsum.
English: For the treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Danish: Til behandling og metafylakse (”gruppebehandling”) af nekrotisk enteritis forårsaget af Clostridium perfringens.
English: Animal species
Danish: Lægemiddelform Dyrearter
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people.
Danish: Begge kan forårsage allergiske reaktioner hos nogle personer.
English: 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.
Danish: Der kan forekomme antagonisme mellem lincomycin og macrolider som f.eks. erythromycin og andre bakteriedræbende antibiotika.
English: PACKAGE LEAFLET: Lincocin 400 mg/g powder for use in drinking water
Danish: INDLÆGSSEDDEL Lincocin 400 mg/g pulver til brug i drikkevand
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin 400 mg/g powder for use in drinking water
Danish: VETERINÆRLÆGEMIDLETS NAVN Lincocin 400 mg/g pulver til opløsning i drikkevand
English: 53., 1123 Hungary
Danish: Budapest, Alkotás u. 53., 1123
English: 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).
Danish: ANGIVELSE AF AKTIVE STOFFER Hvert gram indeholder 400 mg lincomycin (som lincomycinhydrochlorid).
English: 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.
Danish: Med hensyn til æglæggende høns er der ingen data til støtte for en tilbageholdelsestid for æg.
English: 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).
Danish: − Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Oral via the drinking water
Danish: Oral til anvendelse i drikkevand
English: Manufacturer responsible for batch release: To be completed nationally
Danish: Indehaver af markedsføringstilladelsen: Udfyldes nationalt.
English: 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.
Danish: 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.
English: Route of administration
Danish: Andrew Street
English: Pigs, chickens
Danish: Svin, kyllinger Oral
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr: Produktet indeholder lincomycin og laktosemonohydrat.
English: Implementation of the position by the Member States:
Danish: Medlemsstaternes gennemførelse af standpunktet:
English: 26 July 2019
Danish: 26. juli 2019
English: 26 June 2019
Danish: 26. juni 2019
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Danish: Vedtagelse af CMDh's standpunkt ved konsensus: CMDh-mødet i maj 2019 Oversættelser af bilagene for indstillingen fremsendes til de nationale kompetente myndigheder:
English: Rare (affects less than 1 in 1,000 people)
Danish: Sjælden (forekommer hos færre end 1 ud af 1.000 patienter)
English: Section 4.4
Danish: Punkt 4.4
English: Adopted at the 14-17 March 2016 PRAC
Danish: Vedtaget af PRAC d. 14.-17. marts 2016
English: The increased risk appears to be related to the degree and duration of immunosuppression.
Danish: Den øgede risiko synes at være relateret til behandlingens intensitet og varighed.
English: New product information wording - Extracts from PRAC recommendations on signals
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger om signaler
English: Axitinib should be discontinued if the patient develops nephrotic syndrome.
Danish: Axitinib skal seponeres, hvis patienten udvikler nefrotisk syndrom.
English: Not known side effects are (frequency cannot be estimated from the available data):
Danish: Bivirkninger, hvis hyppighed ikke kendes (kan ikke beregnes ud fra forhåndenværende data):
English: • Low fibrinogen levels in the blood (a protein involved in blood clotting)
Danish: • Lavt indhold af fibrinogen i blodet (et protein, der medvirker til blodets størkning)
English: • tumours, including skin cancer.
Danish: • tumorer, herunder hudkræft.
English: Package Leaflet (PL) No changes to the PL are needed.
Danish: Indlægsseddel: Det er ikke nødvendigt at foretage ændringer i indlægssedlen.
English: Mutagenicity and carcinogenicity/Carcinogenicity
Danish: Mutagenicitet og karcinogenicitet
English: 4.8 Undesirable effects
Danish: Punkt 4.8 Bivirkninger
English: • various types of cancers including blood, lymph and skin cancers
Danish: • forskellige former for kræft, herunder blodkræft, lymfekræft og hudkræft
English: Therefore, when taking <X>, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
Danish: 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.
English: Taking <X> could put you at greater risk of:
Danish: Behandling med {X} kan medføre en øget risiko for:
English: Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended.
Danish: Det anbefales at monitorere for proteinuri før og regelmæssigt under behandlingen med axitinib.
English: Frequency not known (cannot be estimated from the available data): hypofibrinogenaemia
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data): hypofibrinogenæmi
English: It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder.
Danish: Det er rapporteret, at seponering af den immunsupprimerende behandling kan medføre partiel regression af den lymfoproliferative sygdom.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with mercaptopurine should be discontinued.
Danish: Hvis MAS opstår eller mistænkes, skal evaluering og behandling startes så hurtigt som muligt, og mercaptopurin skal seponeres.
English: • lymphoproliferative disorders o treatment with <X> increases your risk of getting a type of cancer called lymphoproliferative disorder.
Danish: • lymfoproliferative sygdomme o behandling med {X} øger risikoen for at få en type kræft, der kaldes "lymfoproliferativ sygdom".
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued.
Danish: Hvis MAS opstår eller mistænkes, skal evaluering og behandling startes så hurtigt som muligt, og azathioprin skal seponeres.
English: With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death.
Danish: Ved behandlingsregimer, der består af flere immunsupprimerende lægemidler, herunder thiopuriner, kan dette medføre dødsfald.
English: For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment (see section 4.2).
Danish: Hos patienter, der udvikler moderat til svær proteinuri, skal dosis reduceres eller behandlingen afbrydes midlertidigt (se pkt.
English: Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
Danish: Læger skal være opmærksomme på symptomer på infektion forårsaget af f.eks. Epstein-Barr-virus (EBV) og cytomegalovirus (CMV), da disse kan udløse MAS.
English: Mercaptopurine (XALUPRINE); azathioprineLymphoproliferative disorders (EPITT no 18503)
Danish: Mercaptopurin (Xaluprine); azathioprinlymfoproliferative sygdomme (EPITT nr. 18503)
English: A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities.
Danish: Et behandlingsregime bestående af flere immunsuppressiva, herunder thiopuriner, bør derfor anvendes med forsigtighed, da det kan medføre lymfoproliferative sygdomme, i nogle tilfælde med dødelig udgang.
English: Patients receiving immunosuppressive therapy, including <azathioprine> <mercaptopurine> are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ.
Danish: Patienter i immunsupprimerende behandling, herunder med <azathioprin> <mercaptopurin>, har en øget risiko for at udvikle lymfoproliferative sygdomme og andre maligniteter, især hudcancer (melanom og non-melanom), sarkomer (Kaposi og non-Kaposi) og cervixcancer in situ.
English: What you need to know before you <take> <use> X Warnings and precautions Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X If you are receiving immunosuppressive therapy, taking <X> could put you at greater risk of:
Danish: Det skal <De> <du> vide, før <De> <du> begynder at <tage> <bruge> {X} Advarsler og forsigtighedsregler Kontakt lægen<,> <eller> <apotekspersonalet> <eller sundhedspersonalet>, før <De> <du> <tager> <bruger> {X}.
English: Package leaflet (mercaptopurine and azathioprine) 2.
Danish: Indlægsseddel (mercaptopurin og azathioprin) 2.
English: A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders.
Danish: En kombination af flere immunsuppressiva administreret samtidigt øger risikoen for EpsteinBarr-virus (EBV)-relaterede lymfoproliferative sygdomme.
English: Summary of Product Characteristics (mercaptopurine)
Danish: Produktresumé (mercaptopurin)
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine.
Danish: Makrofag-aktiveringssyndrom (MAS) er en kendt, livstruende tilstand, der kan udvikles hos patienter med autoimmune sygdomme, navnlig inflammatorisk tarmsygdom, og der kan potentielt være en øget følsomhed for udvikling af syndromet ved brug af azathioprin.
English: Rare: neoplasms including lymphoproliferative disorders, skin cancers (melanomas and nonmelanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ…(see section
Danish: cyster og polypper) Sjældne bivirkninger: neoplasmer, herunder lymfoproliferative sygdomme, hudcancer (melanom og non-melanom), sarkomer (Kaposis og non-Kaposis) og cervixcancer in situ ... (se pkt.
English: o A combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).
Danish: o En kombination af flere immunsupprimerende lægemidler, der gives samtidigt, øger risikoen for sygdomme i lymfesystemet på grund af en virusinfektion (Epstein-Barr-virus-relaterede lymfoproliferative sygdomme).
English: In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Danish: Der er rapporteret proteinuri, herunder grad 3- og 4-proteinuri, i kliniske studier med axitinib (se pkt.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD) (unlicensed indication), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine.
Danish: Makrofag-aktiveringssyndrom (MAS) er en kendt, livstruende tilstand, der kan udvikles hos patienter med autoimmune sygdomme, navnlig inflammatorisk tarmsygdom (ikke-godkendt indikation), og der kan potentielt være en øget følsomhed for udvikling af syndromet ved brug af mercaptopurin.
English: • developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis
Danish: • udvikling af en alvorlig lidelse, der hedder makrofag-aktiveringssyndrom (kraftig aktivering af hvide blodlegemer forbundet med en betændelseslignende reaktion (inflammation)).
English: Summary of Product Characteristics (azathioprine)
Danish: Produktresumé (azathioprin)
English: Tigecycline (TYGACIL) - Hypofibrinogenaemia (EPITT no
Danish: Tigecyclin (Tygacil) - hypofibrinogenæmi (EPITT nr. 18479)
English: Axitinib (INLYTA) - Nephrotic syndrome (EPITT no
Danish: Axitinib (Inlyta) - nefrotisk syndrom (EPITT nr. 18484)
English: Blood and lymphatic system disorders
Danish: Produktresumé 4.8 Bivirkninger Tabel over bivirkninger Blod og lymfesystem
English: 10 mg + 20 mg + 30 mg blister (PVC/alu) in a card
Danish: 10 mg + 20 mg + 30 mg
English: These include, among others:
Danish: Disse omfatter blandt andet:
English: This medicine may pose a risk for the environment.
Danish: Dette lægemiddel kan udgøre en risiko for miljøet.
English: * Fatal events were reported.
Danish: * Der var rapporteret letale hændelser.
English: Approximately 90% of patients included in this analysis were Asian or White.
Danish: Ca. 90% af de inkluderede patienter i denne analyse var asiatere eller hvide.
English: Your doctor may decrease the dose of your medicine depending on how well you tolerate it.
Danish: Din læge vil måske nedsætte din dosis af lægemidlet afhængigt af, hvor godt du tåler det.
English: Data based on data cut-off date of 29 July 2016.
Danish: Data baseret på data cut-off-dato den 29. juli 2016.
English: • Swallow the tablet whole with a glass of water.
Danish: • Slug tabletten hel med et glas vand.
English: • Take the tablet at about the same time each day.
Danish: • Tag tabletten på omtrent samme tid hver dag.
English: Dose modifications may be required based on individual safety and tolerability.
Danish: Det kan være nødvendigt at justere dosis baseret på individuel sikkerhed og tolerabilitet.
English: Therefore, the statistical significance of OS improvement could not be formally assessed.
Danish: Den statistiske signifikans af forbedringen af OS kunne således ikke bedømmes tilstrækkeligt.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Danish: Patienter skal opfordres til at tage deres dosis på omtrent samme tidspunkt hver dag.
English: Dose (once daily)
Danish: Dosis (en gang dagligt)
English: Age, race, gender, body weight
Danish: Alder, race, køn og kropsvægt
English: Recommended starting dose
Danish: Anbefalet startdosis
English: Vizimpro is for oral use.
Danish: Vizimpro er til oral anvendelse.
English: • You can take the tablet with or without meals.
Danish: • Du kan tage tabletten sammen med eller uden mad.
English: However, according to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached.
Danish: I overensstemmelse med den hierarkiske model, blev analysen imidlertid stoppet efter ORR-testningen, fordi den statistiske signifikans ikke blev opnået.
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Danish: Ved vurdering af en patients EGFR-mutationsstatus er det vigtigt, at der bliver valgt en grundigt valideret og robust metode for at undgå falsk negative eller falsk positive resultater.
English: Vizimpro has not been studied in children or adolescents and it must not be given to patients under the age of 18 years.
Danish: Børn og unge Vizimpro er ikke blevet undersøgt hos børn eller unge, og det må ikke gives til patienter under 18 år.
English: However, based on the oral bioavailability of 80%, these membrane transport proteins are unlikely to have any impact on dacomitinib absorption.
Danish: Baseret på den orale biotilgængelighed på 80%, er det imidlertid ikke sandsynligt, at disse membrantransportproteiner har indvirkning på absorptionen af dacomitinib.
English: This medicine contains lactose (found in milk or dairy products).
Danish: Dette lægemiddel indeholder lactose (som findes i mælk og mejeriprodukter).
English: Vizimpro tablets come in different strengths.
Danish: Vizimpro tabletter findes i forskellige styrker.
English: Do not take Vizimpro:
Danish: Tag ikke Vizimpro:
English: Symptoms may be similar to those from lung cancer.
Danish: Symptomerne kan være de samme, som dem der opstår ved lungekræft.
English: a. From stratified Cox Regression.
Danish: a. Fra stratificeret Cox-regressionsanalyse.
English: It is not known whether dacomitinib and its metabolites are excreted in human milk.
Danish: Det vides ikke, om dacomitinib og dets metabolitter udskilles i human mælk.