FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/17/1194/014 EU/1/17/1194/015 EU/1/17/1194/016 EU/1/17/1194/023 EU/1/17/1194/024 EU/1/17/1194/025 EU/1/17/1194/026 EU/1/17/1194/027 EU/1/17/1194/028
Danish: EU/1/17/1194/023 EU/1/17/1194/024 EU/1/17/1194/025 EU/1/17/1194/026 EU/1/17/1194/027 EU/1/17/1194/028
English: How to take Febuxostat Mylan
Danish: Sådan skal De tage Febuxostat Mylan
English: Febuxostat Mylan 80 mg film-coated tablets
Danish: Febuxostat Mylan 80 mg filmovertrukne tabletter
English: Renal and urinary disorders
Danish: Udbrud af artritis urica
English: Hepatic impairment
Danish: Hjerte-kar-lidelser
English: FRI
Danish: Ødem
English: EU/1/17/1194/009 EU/1/17/1194/010 EU/1/17/1194/011 EU/1/17/1194/012 EU/1/17/1194/013
Danish: EU/1/17/1194/009 EU/1/17/1194/010 EU/1/17/1194/011 EU/1/17/1194/012 EU/1/17/1194/013 EU/1/17/1194/014 EU/1/17/1194/015 EU/1/17/1194/016
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: • generalised skin rashes
Danish: *, imperiøs vandladning
English: Uncommon:
Danish: Ikke almindelige
English: Posology
Danish: Luftveje
English: Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Danish: Arthritis urica: Den anbefalede dosis til patienter med let nedsat leverfunktion er 80mg.
English: There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk.
Danish: Der er i forbindelse med brug af febuxostat i sjældne tilfælde indberettet udslæt, som kan være livstruende (Stevens-Johnsons syndrom).
English: Tabulated list of adverse reactions
Danish: Oversigt over bivirkninger i tabelform
English: EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020 EU/1/17/1194/021 EU/1/17/1194/022
Danish: EU/1/17/1194/001 EU/1/17/1194/002 EU/1/17/1194/003 EU/1/17/1194/004 EU/1/17/1194/005 EU/1/17/1194/006 EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020 EU/1/17/1194/021 EU/1/17/1194/022
English: • fatigue, chest pain, chest discomfort
Danish: • træthed, smerter i brystet, trykken for brystet
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform
English: Packaging
Danish: Pakningsstør
English: Withdrawal period
Danish: Tilbageholdelsestid relse
English: Target species
Danish: Dyrearter, som lægemidlet er beregnet til
English: Content Package size
Danish: Indgivelsesvej Emballage
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultatet af en procedure i henhold til artikel 29 i direktiv 2001/83/EF, som ændret
English: The European Commission issued a decision on 5 September 2013.
Danish: Europa-Kommissionen traf en beslutning den 5. september 2013.
English: • allergies, including severe allergic reactions;
Danish: • allergier, herunder alvorlige allergiske reaktioner
English: • organ transplantation.
Danish: • organtransplantation
English: What is Okrido?
Danish: Hvad er Okrido?
English: The company wanted the authorisation to be recognised in Germany and the Netherlands (the ‘concerned Member States').
Danish: Virksomheden ønskede denne godkendelse anerkendt i Tyskland og Nederlandene (de “berørte medlemsstater”).
English: Why was Okrido reviewed?
Danish: Hvorfor blev Okrido vurderet igen?
English: EMA/379127/2013 Rev.1 EMEA/H/A-29/1368
Danish: Den 5. september 2013 EMA/379127/2013 Rev.1 EMEA/H/A-29/1368
English: It is available as an oral solution (6mg/ml).
Danish: Det leveres som oral opløsning (6 mg/ml).
English: Okrido is used to treat a range of inflammatory and auto-immune conditions (diseases caused by the body's own defence system attacking normal tissue) including:
Danish: Okrido anvendes til behandling af en række inflammatoriske og autoimmune sygdomme (sygdomme, der skyldes, at kroppens eget forsvarssystem angriber normalt væv), herunder:
English: • some cancers, including leukaemia, lymphoma and myeloma;
Danish: • visse kræfttyper, herunder leukæmi, lymfom og myelom
English: In particular, as the two medicines contain different excipients (inactive ingredients), the Netherlands considered that further studies were needed to show that these differences did not result in relevant differences in the way the two medicines are absorbed by the body.
Danish: Da de to lægemidler indeholder forskellige hjælpestoffer (inaktive indholdsstoffer), fandt Nederlandene behov for yderligere undersøgelser til at vise, at disse forskelle ikke medførte relevante forskelle i den måde, de to lægemidler optages af kroppen på.
English: On 27 June 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Okrido.
Danish: Den 27. juni 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Okrido.
English: • diseases of the lungs (including asthma), upper airways (croup), blood vessels and heart, bowel or kidneys, muscles and joints (including rheumatoid arthritis) or the eye or nervous system;
Danish: • sygdomme i lunger (herunder astma), øvre luftveje (strubehoste), blodkar og hjerte, tarm eller nyrer, muskler og led (herunder leddegigt) eller øjne eller nervesystem
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 5 March 2013.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges lægemiddelstyrelse indbragte den 5. marts 2013 sagen for CHMP til voldgift.
English: Pharmapol Arzneimittelvertrieb GmbH submitted Okrido for mutual recognition on the basis of the initial authorisation granted by the United Kingdom's Medicines and Healthcare products Regulatory Agency on 19 April 2010.
Danish: Pharmapol Arzneimittelvertrieb GmbH indsendte en ansøgning for Okrido med henblik på gensidig anerkendelse på grundlag af den oprindelige godkendelse, der var udstedt af Det Forenede Kongeriges lægemiddelstyrelse den 19. april 2010.
English: The active substance in Okrido, prednisolone sodium phosphate, belongs to a group of medicines called glucocorticoids, which are substances that help to reduce inflammation.
Danish: Det aktive stof i Okrido, prednisolonnatriumphosphat, tilhører lægemiddelgruppen glukokortikoider, som er stoffer, der reducerer inflammation.
English: The CHMP therefore concluded that the benefits of Okrido outweigh its risks, and therefore the marketing authorisation for Okrido should be granted in all concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Okrido opvejer risiciene, og at der derfor burde udstedes markedsføringstilladelse for Okrido i alle de berørte medlemsstater.
English: Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that, based on the data submitted, Okrido is expected to produce comparable levels of the active substance in the body to the reference medicine.
Danish: Efter at have vurderet de foreliggende data og efter den videnskabelige drøftelse i udvalget konkluderede CHMP, at Okrido ud fra de forelagte oplysninger forventes at frembringe samme koncentrationer af det aktive stof i kroppen som referencelægemidlet.
English: Okrido is a medicine that contains the active substance prednisolone sodium phosphate.
Danish: Okrido er et lægemiddel, der indeholder det aktive stof prednisolonnatriumphosphat.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Okrido outweighs its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Okrido opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Det Forenede Kongerige, kan anerkendes i de øvrige EU-medlemsstater.
English: • skin conditions;
Danish: • hudsygdomme
English: Okrido is a generic medicine based on a ‘reference medicine' already authorised in the EU.
Danish: Det betyder, at Okrido svarer til et “referencelægemiddel” som i forvejen er godkendt i EU.
English: The reference medicine was Prednisolone 5 mg soluble tablets by Sovereign.
Danish: Referencelægemidlet var Prednisolone, opløselige tabletter, 5 mg, fra Sovereign.
English: The grounds for the referral were that sufficient data had not been provided to show that Okrido produces comparable levels of the active substance in the body to Prednisolone 5 mg soluble tablets by Sovereign.
Danish: Begrundelsen for indbringelsen var, at der ikke var forelagt tilstrækkelige data til at vise, at Okrido frembringer tilsvarende koncentrationer af det aktive stof som Prednisolone, opløselige tabletter, 5 mg, fra Sovereign.
English: In very rare cases, they may be serious or fatal.
Danish: I meget sjældne tilfælde kan de være alvorlige eller dødelige.
English: This summary was last updated in March 2018.
Danish: Dette sammendrag blev sidst ajourført i 03-2018.
English: Further information on Metacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Metacam findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Metacam received a marketing authorisation valid throughout the EU for Metacam on 7 January 1998.
Danish: Metacam fik en markedsføringstilladelse med gyldighed i hele EU den 7. januar 1998.
English: Other information about Metacam
Danish: Andre oplysninger om Metacam
English: These side effects occur usually within the first week of treatment and are generally transient (temporary).
Danish: Disse bivirkninger opstår som regel inden for den første uge af behandlingen og er sædvanligvis forbigående.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Danish: Personer, som er hypersensitive (allergiske) over for NSAID'er, bør undgå kontakt med Metacam.
English: The product is not authorised to use in horses producing milk for human consumption.
Danish: Produktet bør ikke anvendes til heste, der producerer mælk til menneskeligt konsum.
English: Injections may be into a vein, muscles or under the skin.
Danish: Injektionerne kan foretages i en vene, i muskler eller under huden.
English: For the 20 mg/ml and 40 mg/ml solution for injection the meat withdrawal period is 5 days and for the 15 mg/ml oral suspension it is 3 days.
Danish: I forbindelse med injektionsvæsken, 20 mg/ml og 40 mg/ml, er tilbageholdelsestiden for kød fem dage, og for den orale suspension, 15 mg/ml, er den tre dage.
English: The European Medicines Agency decided that Metacam's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Metacam opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The withdrawal period for meat is 5 days.
Danish: Tilbageholdelsestiden for kød er fem dage.
English: Another study in cattle involved 501 calves with diarrhoea.
Danish: En yderligere undersøgelse af kvæg omfattede 501 kalve med diarré.
English: Why is Metacam approved in the EU?
Danish: Hvorfor blev Metacam godkendt i EU?
English: An overview of Metacam and why it is authorised in the EU
Danish: En oversigt over Metacam og hvorfor det er godkendt i EU
English: All sows also received antibiotics.
Danish: Alle søer modtog også antibiotika.
English: Metacam contains the active substance meloxicam.
Danish: Metacam indeholder det aktive stof meloxicam.
English: The study showed that the dogs receiving meloxicam injection followed by oral doses had the best results in improving mobility based on a standard scoring system.
Danish: Undersøgelsen viste, at de hunde, der fik injektion af meloxicam efterfulgt af orale doser, opnåede det bedste resultat i form af forbedret mobilitet, baseret på et standardscoresystem.
English: What is Metacam and what is it used for?
Danish: Hvad er Metacam, og hvad anvendes det til?
English: If the product is accidentally swallowed or self-injected by a person, the advice of a doctor should be sought immediately.
Danish: Hvis en person utilsigtet indtager lægemidlet gennem munden eller ved selvinjektion, bør der straks søges læge.
English: The withdrawal period is 15 days for meat and 5 days for milk.
Danish: Tilbageholdelsestiden er 15 dage for kød og fem dage for mælk.
English: Metacam can only be obtained with a prescription.
Danish: Metacam udleveres kun efter recept.
English: A temporary swelling at the injection site can occur but resolves without intervention.
Danish: Der kan opstå en midlertidig hævelse på injektionsstedet, som dog svinder uden indgreb.
English: For further information about using Metacam, see the package leaflet or contact your veterinarian or pharmacist.
Danish: For mere information om brug af Metacam, se indlægssedlen, eller kontakt dyrlægen eller apotekspersonalet.
English: What are the risks associated with Metacam?
Danish: Hvilke risici er der forbundet med Metacam?
English: In addition to antibiotic therapy animals either received a single injection of Metacam or flunixin (another NSAID) for up to 5 days.
Danish: Ud over antibiotikabehandling modtog dyrene enten en enkelt injektion af Metacam eller flunixin (et andet NSAID) i op til 5 dage.
English: The withdrawal period is the time allowed after administration of the medicine before an animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før et dyr kan slagtes og kødet kan anvendes til menneskeligt konsum.
English: The formulation and dose to use depends on the animal species, its bodyweight and the condition being treated.
Danish: Den formulering og dosis, der skal anvendes, afhænger af dyret, dets kropsvægt og den sygdom, der behandles.
English: 46 cats received Metacam oral suspension for 28 days whilst 48 cats received placebo oral suspension.
Danish: 46 katte modtog Metacam som oral suspension i 28 dage, mens 48 katte modtog en uvirksom oral suspension.
English: Metacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs, cats and guinea pigs.
Danish: Metacam er et antiinflammatorisk lægemiddel, der anvendes hos kvæg, svin, heste, hunde, katte og marsvin.
English: These side effects resolve once treatment has stopped.
Danish: Disse bivirkninger forsvinder ved behandlingens ophør.
English: Metacam oral suspension was given for 5 days and compared with ketoprofen (another NSAID).
Danish: Metacam som oral suspension blev givet i 5 dage og sammenlignet med ketoprofen (et andet NSAID).
English: Metacam was effective in improving mobility and reducing pain from day 0-14 compared to the control group.
Danish: Metacam var effektivt til at bedre mobiliteten og nedsætte smerter fra dag 0 til 14 i forhold til kontrolgruppen.
English: The 40 mg/ml solution for injection should not be handled by pregnant women or women attempting to conceive as accidental self-injection may affect the development of the baby in the womb.
Danish: Injektionsvæsken, 40 mg/ml, bør ikke håndteres af gravide eller kvinder, der forsøger at blive gravide, da utilsigtet selvinjektion kan berøre det ufødte barns udvikling.
English: 37 cats received Metacam and 39 cats received carprofen (another NSAID) by subcutaneous (under the skin) injection immediately after receiving anaesthesia.
Danish: 37 katte fik Metacam, og 39 katte fik carprofen (et andet NSAID) ved subkutan injektion (under huden) umiddelbart efter at have fået anæstesi.
English: Metacam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Metacam indeholder meloxicam, som tilhører lægemiddelgruppen ikke-steroide antiinflammatoriske lægemidler (NSAID'er).
English: The main measure of effectiveness was blood levels of the stress hormone cortisol 30 minutes after surgery.
Danish: Det vigtigste mål for effektiviteten var blodets indhold af stresshormonet kortisol 30 minutter efter operationen.
English: All calves were given oral rehydration therapy and antibiotics.
Danish: Alle kalve gennemgik en oral rehydreringsbehandling og fik antibiotika.
English: A study in 187 sows with puerperal septicaemia and toxaemia compared Metacam with flunixin (another NSAID).
Danish: I et studie med 187 søer med puerperal septikæmi og toksæmi blev Metacam sammenlignet med flunixin (et andet NSAID).
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere enzymet cyclooxygenase, der medvirker ved dannelsen af prostaglandiner.
English: The main measure of effectiveness was the assessment of pain score at various time points up to 20 hours post-surgery.
Danish: Hovedeffektmålet var scoreværdierne for smerte på forskellige tidspunkter i op til 20 timer efter operationen.
English: A laboratory study in 30 guinea pigs compared Metacam oral suspension with placebo given about 45 minutes before surgical castration and on each of the following two days.
Danish: I en laboratorieundersøgelse hos 30 marsvin sammenlignedes Metacam, oral suspension, med placebo ved indgift ca. 45 minutter før kirurgisk kastration og på hver af de efterfølgende to dage.
English: The main measure of effectiveness was based on clinical signs of diarrhoea and the animal's behaviour, feed intake, body temperature, respiratory rate, heart rate and general condition.
Danish: Virkningen blev hovedsagelig målt på kliniske symptomer på diarré og dyrets adfærd, fødeindtagelse, kropstemperatur, vejrtrækningshastighed, hjerterytme og almentilstand.
English: Guinea pigs treated with Metacam had significantly higher frequency of feed intake (240 events) over three days, indicating that their pain was reduced, compared with guinea pigs given placebo (207 events).
Danish: Marsvin, der blev behandlet med Metacam, havde væsentligt hyppigere foderindtag (240 hændelser) i løbet af tre dage som tegn på, at de havde færre smerter end marsvin, der fik placebo (207 hændelser).
English: 326 cattle received Metacam given as an injection together with antibiotic therapy whilst 326 cattle received a placebo (dummy) injection and antibiotic therapy.
Danish: 326 stykker kvæg fik Metacam som injektion sammen med antibiotikabehandling, mens 326 stykker kvæg modtog en uvirksom injektion (placebo) og antibiotikabehandling.
English: In cattle, pigs and horses in very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Danish: Hos kvæg, grise og heste kan der i meget sjældne tilfælde forekomme anafylaktiske (allergiske) reaktioner, som kan være alvorlige (herunder dødelige).
English: Metacam injection was studied in 76 cats undergoing ovariohysterectomy.
Danish: Metacam som injektion blev undersøgt hos 76 katte, der fik foretaget ovariohysterektomi.
English: The main measure of effectiveness was based on their general condition, milk appearance and signs of udder inflammation.
Danish: Virkningen blev hovedsagelig målt på deres almentilstand, mælkens udseende og symptomer på yverbetændelse.
English: The study showed Metacam to be effective in reducing pain associated with the dehorning procedure.
Danish: Undersøgelsen viste, at Metacam er effektivt til at reducere smerter ved afhorning.
English: In one study three different meloxicam treatment schedules for acute locomotor disorders were compared.
Danish: I én undersøgelse sammenlignedes tre forskellige behandlingsprogrammer med meloxicam mod akutte lidelser i bevægeapparatet.
English: In addition slight urticaria (itchy rash) and diarrhoea can occur which are both typical side effects of NSAIDs and which resolve by themselves.
Danish: Ydermere kan der forekomme let nældefeber (kløende udslæt) og diarré, som begge er typiske NSAIDbivirkninger, der forsvinder af sig selv.
English: Metacam was comparable to flunixin in treating signs of infection and inflammation associated with puerperal septicaemia and toxaemia.
Danish: Metacam var sammenligneligt med flunixin ved behandling af symptomer på infektion og inflammation i forbindelse med puerperal septikæmi og toksæmi.
English: Calves treated with Metacam showed a significant improvement in their signs of diarrhoea compared with the control group.
Danish: Hos kalve behandlet med Metacam sås en betydelig bedring i symptomerne på diarré sammenlignet med kontrolgruppen.
English: The effectiveness of Metacam injection was studied in 209 pigs with non-infectious locomotor disorders.
Danish: Virkningen af Metacam som injektion blev undersøgt hos 209 grise med ikke-smittefarlige lidelser i bevægeapparatet.
English: It can be used to relieve post-operative pain following dehorning in calves and as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Danish: Det kan anvendes til lindring af postoperative smerter ved afhorning af kalve og som støtteterapi ved behandling af akut yverbetændelse (mastitis) i kombination med antibiotika.
English: Metacam significantly reduced lameness with 49% of the Metacam treated pigs with no lameness compared with 27% of the pigs which received the placebo treatment.
Danish: 49 % af grisene behandlet med Metacam havde ingen halten sammenlignet med 27 % af de grise, der havde modtaget den uvirksomme behandling.
English: Metacam 5 mg/ml solution for injection was comparable to carprofen in reducing post-operative pain in cats following ovariohysterectomy.
Danish: Metacam, injektionsvæske, opløsning, 5 mg/ml, var sammenligneligt med carprofen til at formindske postoperative smerter hos katte efter ovariohysterektomi.
English: In very rare cases anaphylactoid reactions and elevated liver enzymes have been reported.
Danish: Der er i meget sjældne tilfælde indberettet anafylaktiske reaktioner og forhøjede leverenzymer.
English: Metacam treated piglets had significantly reduced blood cortisol levels (which indicates that they were exposed to lower levels of stress) 30 minutes after castration compared with the control group.
Danish: Smågrise, der blev behandlet med Metacam, havde væsentligt lavere indhold af kortisol i blodet (som tegn på lavere stressniveau) 30 minutter efter kastration end kontrolgruppen.
English: In pigs, Metacam is used in non-infectious locomotor disorders (diseases that affect the ability to move) to reduce lameness and inflammation, relieve post-operative pain associated with minor soft tissue surgery such as castration, and for supportive therapy together with antibiotics in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome, a bacterial infection of the udder and/or the womb).
Danish: Hos grise anvendes Metacam i forbindelse med ikke-smittefarlige sygdomme i bevægeapparatet (sygdomme, som påvirker bevægelsesevnen) til at mindske halten og inflammation, til at lindre postoperative smerter forbundet med mindre bløddelskirurgi såsom kastration, og til støtteterapi i kombination med antibiotikabehandling ved behandling af sygdomme, der opstår efter fødsel (faring), såsom puerperal septikæmi og toksæmi (mastitis-metritis-agalactia-syndrom, en bakterieinfektion i yveret og/eller livmoderen).