FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rebetol, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rebetol, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The haemolytic anaemia may affect a patient's heart function and lead to abnormal test values for substances such as uric acid and bilirubin in the blood.
Danish: Hæmolytisk anæmi kan påvirke patienters hjertefunktion og medføre unormale værdier for stoffer såsom urinsyre og bilirubin i blodet.
English: It can also be used in previously untreated patients aged three years and over whose livers are working properly.
Danish: Det kan også anvendes hos patienter på over tre år, der ikke tidligere har modtaget behandling, og hvis lever fungerer korrekt.
English: In most of the studies, the main measure of effectiveness was the amount of virus in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later.
Danish: I de fleste af undersøgelserne var det primære effektmål mængden af hepatitis C-virus i blodet før og efter seks måneders eller et års behandling og ved opfølgningen seks måneder senere.
English: Why has Rebetol been approved?
Danish: Hvorfor blev Rebetol godkendt?
English: Triple therapy led to a 30% increase in the number of previously untreated early responders who were cured after six months.
Danish: Den tredobbelte behandling resulterede i en stigning på 30 % i antallet af tidligere ubehandlede patienter, der var helbredt efter seks måneder.
English: It has also been studied in 1,699 adults whose disease had come back after previous treatment or whose previous treatment had failed.
Danish: Rebetol blev ligeledes undersøgt hos 1 699 voksne, hvor sygdommen var kommet tilbage efter en tidligere behandling, eller hvor en tidligere behandling var slået fejl.
English: Combination treatment including Rebetol was effective in around a quarter of the adults whose disease had come back after previous treatment or whose previous treatment did not work, and over half of the children and adolescents treated.
Danish: Kombinationsbehandling med Rebetol var effektiv hos ca. en fjerdedel af de voksne, hvis sygdom var kommet tilbage efter tidligere behandling, eller hvor den tidligere behandling var slået fejl, og hos over halvdelen af de behandlede børn og unge.
English: The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Danish: Det aktive stof i Rebetol, ribavirin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: The dose of Rebetol is based on the patient's body weight, and ranges from five to six capsules a day in adults.
Danish: Dosen af Rebetol beregnes efter patientens legemsvægt og ligger på mellem fem og seks kapsler dagligt hos voksne patienter.
English: What is Rebetol?
Danish: Hvad er Rebetol?
English: The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.
Danish: I disse undersøgelser blev effektiviteten hovedsagelig målt på det antal patienter, der ikke havde påviselige mængder af hepatitis C-virus i blodet 24 uger efter behandlingens afslutning.
English: In adults who had not been treated before, Rebetol in combination with interferon alfa 2b was more effective than interferon alfa 2b on its own, with 41% of the patients responding to the combination treatment and 16% to the interferon alone.
Danish: Hos ikke tidligere behandlede voksne var Rebetol i kombination med interferon alfa-2b mere effektivt end interferon alfa-2b alene, idet 41 % af patienterne responderede på kombinationsbehandlingen, og 16 % responderede på interferon alene.
English: Additional data from the published literature show the positive effects of ribavirin-containing medicines when taken in different combinations, including combinations with peginterferon alfa-2a and a class of medicines known as direct acting antivirals (or DAAs).
Danish: Supplerende data fra faglitteraturen påviser ribavirinholdige lægemidlers positive virkning, når de tages i forskellige kombinationer, herunder i kombination med peginterferon alfa-2a og en gruppe af lægemidler kaldet direkte virkende antivirale midler (eller DAA'er).
English: The Committee noted that Rebetol in combination with other medicines, including peginterferon alfa and DAAs is effective against long-term hepatitis C virus infection in adults and children.
Danish: Udvalget konstaterede, at Rebetol i kombination med andre lægemidler, herunder peginterferon alfa og DAA'er, er effektiv mod langvarig infektion med hepatitis C-virus hos voksne og børn.
English: Rebetol is used in combination with other medicines to treat adults with long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Danish: Rebetol anvendes i kombination med andre lægemidler til behandling af voksne patienter med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
English: Rebetol in combination with peginterferon alfa 2b was also effective in adults with cirrhosis or HIV.
Danish: Rebetol i kombination med peginterferon alfa-2b var også effektivt hos voksne med cirrose eller hiv.
English: For the full list of side effects reported with Rebetol, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rebetol fremgår af indlægssedlen.
English: In all of the studies, Rebetol was given in combination with interferon alfa-2b or peginterferon alfa-2b.
Danish: I alle undersøgelser blev Rebetol givet i kombination med interferon alfa-2b eller peginterferon alfa-2b.
English: What benefit has Rebetol shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rebetol?
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ribavirin in combination with peginterferon alfa 2b and boceprevir was shown to be more effective than the dual combination with peginterferon alfa 2b alone.
Danish: I undersøgelserne med tredobbelt kombinationsbehandling hos patienter med hepatitis C type 1 og kompenseret leversygdom var ribavirin i kombination med peginterferon alfa-2b og boceprevir mere effektivt end den dobbelte kombination med peginterferon alfa-2b alene.
English: Response rates were higher when Rebetol was used with peginterferon alfa 2b.
Danish: Responsraterne var højere, når Rebetol blev anvendt sammen med peginterferon alfa-2b.
English: How has Rebetol been studied?
Danish: Hvordan blev Rebetol undersøgt?
English: What is Rebetol used for?
Danish: Hvad anvendes Rebetol til?
English: How is Rebetol used?
Danish: Hvordan anvendes Rebetol?
English: Rebetol is taken with food each day in two divided doses (morning and evening).
Danish: Den daglige dosis Rebetol er fordelt på to doser (morgen og aften) og tages ved måltiderne.
English: How does Rebetol work?
Danish: Hvordan virker Rebetol?
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ribavirin in a triple therapy combination with peginterferon alfa-2b and boceprevir.
Danish: Der blev udført to hovedundersøgelser med i alt 1 503 voksne patienter med hepatitis C type 1 og kompenseret leversygdom.
English: This summary was last updated on: 02-2013.
Danish: Dette sammendrag blev sidst ajourført den: 02-2013.
English: A second dose may be given after 24 hours if required.
Danish: Efter den første dosis kan der gives endnu en dosis efter 24 timer, hvis det er nødvendigt.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Recocam on 13/09/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Recocam den 13/09/2011.
English: Other information about Recocam:
Danish: Andre oplysninger om Recocam:
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Recocam.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med Recocam.
English: The medicine should not be used in horses producing milk for human consumption.
Danish: Lægemidlet bør ikke anvendes til heste, som producerer mælk til menneskeligt konsum.
English: The withdrawal period for Recocam for meat is 15 days for cattle and five days for pigs and horses.
Danish: Tilbageholdelsestiden for kød er 15 dage for kvæg og fem dage for svin og heste.
English: Recocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Danish: Recocam er et lægemiddel til kvæg, grise og heste, som indeholder det aktive stof meloxicam.
English: As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Danish: Da prostaglandinerne er de stoffer, der udløser betændelse, smerter, ekssudation og feber, mindsker meloxicam disse kliniske tegn.
English: The Committee recommended that Recocam be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Recocam.
English: Recocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Recocam indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikke-steroide antiinflammatoriske lægemidler (NSAID'er).
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere et enzym kaldet cyclooxygenase, der medvirker ved dannelsen af prostaglandin.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan der forekomme anafylaktiske reaktioner.
English: The CVMP considered that, in accordance with European Union requirements, Recoocam is bioequivalent to Metacam.
Danish: CVMP vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Recoocam er bioækvivalent med Metacam.
English: Therefore the CVMP's view was that, as for Metacam, Recocam's benefits are greater than its risks when used for the approved indications.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Recocam ligesom Metacam opvejer risiciene, når det anvendes til de godkendte indikationer.
English: What is the risk associated with Recocam?
Danish: Hvilken risiko er der forbundet med Recocam?
English: It can be used with oral re-hydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle.
Danish: Det kan anvendes ved diarré med oral tilførsel af vand hos kalve, der er mere end en uge gamle, og hos ikke-lakterende ungkvæg.
English: Although Recocam is a generic medicine no bioequivalence studies have been provided as the composition of the product is sufficiently similar to the reference product Metacam for the products to be considered essentially similar.
Danish: Selvom Recocam er et generisk lægemiddel, er der ingen bioækvivalensundersøgelser gennemført, da sammensætningen af lægemidlet og referencelægemidlet Metacamen er tilstrækkelig ens til, at lægemidlerne kan anses for i det væsentlige at svare til hinanden.
English: Milk can be taken five days after administration in cattle.
Danish: Der kan malkes fem dage efter indgivelse af lægemidlet til kvæg.
English: Recocam is a ‘generic' medicine which means that Recocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Danish: Recocam er et generisk lægemiddel, hvilket betyder, at Recocam svarer til et ”referenceveterinærlægemiddel”, som allerede er godkendt i EU (Metacam).
English: Recocam was considered to be bioequivalent with the reference medicine.
Danish: Recocam blev anset for at være bioækvivalent med referencelægemidlet.
English: It is given as a single injection of 0.4 mg per kg body weight into a muscle.
Danish: Det gives som en enkelt injektion på 0,4 mg pr. kg. kropsvægt i en muskel.
English: It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of certain diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.
Danish: Recocam anvendes til svin med henblik på at reducere symptomerne på halten og betændelse i forbindelse med ikke-smittefarlige sygdomme i bevægeapparatet (sygdomme, som påvirker bevægelsesevnen) og til behandling af visse sygdomme, der opstår efter faring, såsom puerperal septikæmi og toksæmi (mastitis-metritis-agalactia-syndrom) i kombination med passende antibiotikabehandling.
English: Why has Recocam been approved?
Danish: Hvorfor blev Recocam godkendt?
English: Consequently, Recocam's benefit is taken as being the same as that of the reference medicine.
Danish: Derfor anses fordelene ved Recocam for at være de samme som referencelægemidlets.
English: In cattle and pigs, subcutaneous, intramuscular and intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of cattle treated in clinical studies.
Danish: Der forekom kun let og forbigående hævelse på injektionsstedet efter subkutan administration hos mindre end 10 % af kvæget i de kliniske undersøgelser.
English: In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Danish: Recocam anvendes til kvæg i kombination med passende antibiotikabehandling for at mindske de kliniske tegn på akut respiratorisk infektion (infektion i lunger og luftveje) og til behandling af akut mastitis (yverbetændelse).
English: Recocam is ‘bioequivalent' to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
Danish: Recocam er ”bioækvivalent” med referenceveterinærlægemidlet, hvilket betyder, at Recocam svarer til Metacam, hvad angår den måde, hvorpå det optages og virker i kroppen.
English: What is Recocam used for?
Danish: Hvad anvendes Recocam til?
English: How has Recocam been studied?
Danish: Hvordan blev Recocam undersøgt?
English: What is Recocam?
Danish: Hvad er Recocam?
English: Recocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein.
Danish: Hos kalve gives Recocam som en enkelt injektion på 0,5 mg pr. kg. kropsvægt under huden eller i en vene.
English: Recocam is used in horses to relieve colic (abdominal pain) and for the alleviation of inflammation and relief of pain in musculo-skeletal disorders.
Danish: Recocam anvendes til heste til at afhjælpe kolik (mavesmerter) og betændelse og smerter ved lidelser i bevægeapparatet.
English: Recocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein.
Danish: Recocam gives som en enkelt injektion på 0,6 mg pr. kg. kropsvægt i en vene.
English: What benefit has Recocam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Recocam?
English: No information is available.
Danish: Der findes ingen tilgængelig information.
English: - Milk:
Danish: - Mælk:
English: Strict aseptic precautions should be observed.
Danish: Der bør observeres strenge aseptiske forsigtighedsregler.
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Danish: Brugen af produktet bør være baseret på følsomhedstest og tage hensyn til officiel og lokal antimikrobiel politik.
English: The dosage was repeated 48 hours later.
Danish: Doseringen blev gentaget efter 48 timer.
English: Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Danish: Håndter ikke dette produkt, hvis De ved, at De er sensibiliseret eller hvis De er blevet rådet til ikke at arbejde med sådanne præparater.
English: 1 Marketing Authorisation not granted Reference Member State for the Mutual recognition Procedure
Danish: 1 Markedsføringstilladelse afslået Referencemedlemsstaten for den gensidige anerkendelsesprocedure
English: 88 days
Danish: 88 dage
English: Escherichia coli resistance has been reported.
Danish: Der er blevet rapporteret om Escherichia coli resistens.
English: Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigt, læber eller øjne eller åndedrætsbesvær er mere alvorlige symptomer, som kræver øjeblikkelig lægehjælp.
English: By their nature such chromosomal mutations tend to be relatively slow in developing and occur primarily by vertical transmission.
Danish: I kraft af deres natur har sådanne kromosomale mutationer tendens til at blive udviklet ret langsomt, og de opstår primært ved lodret transmission.
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Danish: FREMSTILLERENS BATCHNUMMER <Batch> <Lot> <BN> {nummer}
English: 06516 CARROS CEDEX FRANCE
Danish: 06516 CARROS CEDEX FRANKRIG
English: Pharmacotherapeutic group: Penicillins with extended spectrum ATCVet code: QJ01CA04
Danish: Farmakoterapeutisk gruppe: Penicilliner med udvidet spektrum ATCvet-kode: QJ01CA04
English: In case of the occurrence of allergic reaction, the treatment should be immediately withdrawn.
Danish: Hvis der opstår en allergisk reaktion, bør behandlingen straks seponeres.
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY} or <month YYYY> PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN {måneder/år} eller <måneder/år> FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant.
English: (as trihydrate) Excipient:
Danish: (som trihydrat) Hjælpestof:
English: Intramuscular injection (cattle, pigs).
Danish: Intramuskulær injektion (kvæg, svin).
English: In case of accidental contact with eyes, rinse immediately with copious amounts of water.
Danish: I tilfælde af en utilsigtet kontakt med øjnene, skyl øjeblikkeligt med rigelige mængder vand.
English: However, an ADI for penicillins was not established.
Danish: Der blev imidlertid ikke fastsat en ADI-værdi for penicilliner.
English: The use of heavier animals would have given extra assurance about residues levels at the injection site and would have made all studies homogenous.
Danish: Brugen af tungere dyr ville have givet større sikkerhed om restkoncentrationerne på injektionsstedet og ville have gjort alle undersøgelserne ensartede.
English: Shake well before use.
Danish: Omryst godt før brug.
English: It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine.
Danish: Det anbefales, at den maksimalt administrerede mængde pr. injektionssted ikke overskrider 20 ml hos kvæg og 5 ml hos svin.
English: - Pigs:
Danish: - Svin:
English: On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table:
Danish: På dette grundlag har CVMP foreslået MRL-værdier for amoxicillin og andre penicilliner, og amoxicillin indgår nu i bilag I til Rådets forordning (EØF) nr. 2377/90 som angivet i følgende tabel:
English: If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Danish: Hvis De udvikler symptomer som f.eks. udslæt efter eksponering, bør De rådspørge en læge og vise lægen denne advarsel.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin.
Danish: En uhensigtsmæssig brug af produktet kan forøge prævalensen af resistente bakterier over for amoxicillin.
English: Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person.
Danish: På baggrund af kendte tilfælde af allergiske reaktioner ved meget små doser anbefalede JECFA, at den daglige indtagelse af benzylpenicillin med føden holdes så lav som praktisk muligt og i alle tilfælde under 30 µg moderstof pr. person.
English: Aluminium stearate Propylene glycol dicaprylate/dicaprate
Danish: Aluminiumstearat Propylenglycol dicaprylat/dicaprat
English: Accidental injection is dangerous - see package leaflet before use.
Danish: Utilsigtet injektion er farlig - læs indlægssedlen inden brug.
English: Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Danish: Der bør anvendes en smalspektret antibakteriel terapi som primær behandling, hvor følsomhedstestene tyder på, at denne fremgangsmåde sandsynligvis vil være effektiv.
English: The mean half-life of elimination is 7 hours.
Danish: Middel halveringstiden for elimination er på 7 timer.
English: However, there are data to show residue depletion from at least one injection site which received the maximum volume and therefore the studies could be accepted for the purposes of setting the meat withdrawal period in cattle.
Danish: Der foreligger imidlertid data, som viser restkoncentrationen fra mindst et injektionssted, som blev indgivet den maksimale volumen, og derfor kan undersøgelserne accepteres til fastsættelse af tilbageholdelsestiden for kød fra kvæg.
English: Do not use in animals with known hypersensitivity to penicillin or other substances of the β-lactam group.
Danish: Bør ikke anvendes til dyr med kendt overfølsomhed over for penicillin eller andre stoffer i β-lactam gruppen.
English: Its structure contains the β-lactam ring and thiazolidine ring common to all penicillins.
Danish: Dens struktur indeholder β-lactam ringen og thiazolidin ringen, som er fælles for alle penicilliner.
English: The mean half-life of elimination is 12 hours.
Danish: Middel halveringstiden for elimination er på 12 timer.
English: Hypersensitity reactions unrelated to dose can be observed.
Danish: Der kan blive observeret overfølsomme reaktioner, som ikke er dosisrelaterede.
English: A withdrawal period of 88 days is therefore established for cattle.
Danish: Der blev derfor fastsat en tilbageholdelsestid på 88 dage for kvæg.
English: Amoxicillin belongs to β-lactams antibiotic family.
Danish: Amoxicillin tilhører gruppen med β-lactam antibiotika.
English: Considering that there is data at an additional time point (90 days) where residues were below the limit of quantification the addition of a 10 % ‘uncertainty factor' was accepted.
Danish: Da der foreligger data for endnu et tidspunkt (dag 90), hvor restkoncentrationerne lå under kvantificeringsgrænsen, blev tilføjelsen af en usikkerhedsfaktor på 10 % accepteret.
English: The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Danish: CVMP har fastsat MRL-værdierne således, at forbrugernes samlede indtagelse med føden ikke vil overskride denne grænse på 30 µg.
English: However, the actual withdrawal period for the product is to be based on the injection site residues.
Danish: Selve tilbageholdelsestiden for produktet skal imidlertid baseres på restkoncentrationerne på injektionsstedet.
English: This veterinary medicinal product does not require any special storage conditions required.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: The other two kidney samples were below the limit of quantification (25 µg/kg).
Danish: De to øvrige nyreprøver lå under kvantificeringsgrænsen (25 µg/kg).