FrancophonIA/ELRC3.0 huggingface dataset:
English: inhaler (ABS/PE/PP) 3 inhalers (3 x 60 doses)
Danish: 3 inhalatorer (3 x 60 doser)
English: Pack size inhaler (ABS/PE/PP) 1 inhaler (60 doses)
Danish: 1 inhalator (60 doser)
English: Treatment is once daily.
Danish: Behandlingen er én gang dagligt.
English: This summary was last updated in December 2016.
Danish: Dette sammendrag blev sidst ajourført i december 2016.
English: The overall duration of treatment depends on the horse's response, but should not exceed 14 days.
Danish: Den samlede varighed af behandlingen afhænger af hestens reaktion, men bør ikke overstige 14 dage.
English: The European Commission granted a marketing authorisation valid throughout the EU for Equioxx on 25 June 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equioxx den 25. juni 2008.
English: These are typically mild and resolve without treatment.
Danish: Disse er typisk milde og forsvinder normalt uden behandling.
English: The full EPAR for Equioxx can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Equioxx findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This authorisation was based on the authorisation granted to Previcox in 2004 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Equioxx i 2004 ("informeret samtykke").
English: Two forms of a medicine are bioequivalent when they produce the same levels of active substance in the body.
Danish: To lægemiddelformer er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
English: This is a summary of the European public assessment report (EPAR) for Equioxx.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Equioxx.
English: The withdrawal period for meat from horses treated with Equioxx is 26 days.
Danish: Tilbageholdelsestiden for kød fra heste, der behandles med Equioxx, er 26 dage.
English: It contains the active substance firocoxib.
Danish: Det indeholder det aktive stof firocoxib.
English: People should avoid contact of the medicine with eyes and skin and wash their hands after handling the product.
Danish: Personer bør undgå, at lægemidlet kommer i kontakt med øjne og hud, og vaske hænder efter håndtering af produktet.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Equioxx's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Equioxx opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The dose depends on the bodyweight of the animal except for the tablets which are for horses of 450 to 600 kg bodyweight and where the dose is one tablet.
Danish: Dette omfatter dog ikke tabletter til heste, som vejer mellem 450 -600 kg, hvor dosen er en tablet.
English: By reducing the production of prostaglandins, Equioxx helps reduce the responses of inflammation, including pain.
Danish: Ved at hæmme produktionen af prostaglandiner bidrager Equioxx til at mindske reaktionerne på betændelse, herunder smerte.
English: The studies showed that Equioxx oral paste given daily for 14 days was as effective as the comparator medicines.
Danish: Undersøgelserne viste, at Equioxx i oral pasteform givet dagligt i 14 dage var ligeså effektivt som sammenligningslægemidlet.
English: Equioxx is a medicine used in horses to relieve pain and inflammation in the joints caused by osteoarthritis (a long-term disease causing damage and pain in the joints) and to reduce the lameness that is associated with the disease.
Danish: Equioxx er et lægemiddel, der anvendes til heste for at lindre smerte og inflammation i leddene forårsaget af osteoarthritis (en langvarig sygdom, der medfører beskadigelse og smerte i leddene) og for at reducere lammelse, der er forbundet med sygdommen.
English: The solution for injection is given into a vein while the paste and tablets are given by mouth.
Danish: Opløsningen til injektion indgives i en vene, mens pastaen og tabletterne gives gennem munden.
English: For the full list of all side effects reported with Equioxx and the full list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Equioxx og den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: The active substance in Equioxx, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oygenase-s (COX-2) inhibitors' (or Coxibs).
Danish: Det aktive stof i Equioxx, firocoxib, er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), der tilhører gruppen af "cyclo-oxygenase 2 (COX-2)-hæmmere" (eller Coxibs) .
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Danish: Det blokerer COX2-enzymet og hæmmer dermed produktionen af prostaglandiner, der medvirker i betændelsesprocessen.
English: This means that the solution for injection and the chewable tablets can be expected to produce similar results to the oral paste.
Danish: Dette betyder, at opløsningen til injektion og tyggetabletterne kan forventes at danne resultater, der svarer til resultaterne for oral pasta
English: Two field studies investigated the effectiveness of Equioxx oral paste in treating horses with lameness of more than 4 weeks due to osteoarthritis.
Danish: To feltundersøgelser så nærmere på virkningen af Equioxx i oral pastaform til behandling af heste med lammelse, der varer mere end 4 uger på grund af osteoarthritis.
English: It is not intended to provide practical advice on how to use Equioxx.
Danish: Det er ikke en praktisk vejledning i, hvordan Equioxx bør anvendes.
English: Equioxx can only be obtained with a prescription.
Danish: Equioxx udleveres kun efter recept.
English: One study in the USA compared Equioxx to another NSAID medicine, phenylbutazone, and the second study in Europe compared Equioxx to the NSAID
Danish: En undersøgelse i USA sammenlignede Equioxx med et andet NSAID-lægemiddel, phenylbutazon, og den anden undersøgelse sammenlignede Equioxx med et NSAID, vedaprofen.
English: What is Equioxx and what is it used for?
Danish: Hvad er Equioxx, og hvad anvendes det til?
English: Other information about Equioxx:
Danish: Andre oplysninger om Equioxx
English: If the medicine is accidentally swallowed or someone accidentally injects themselves, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis en person indtager eller utilsigtet injicerer sig selv med lægemidlet, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Equioxx must not be used at the same time as corticosteroid medicines or other NSAIDs.
Danish: Equioxx må ikke anvendes samtidig med kortikosteroider eller andre NSAID'er.
English: Why is Equioxx approved?
Danish: Hvorfor blev Equioxx godkendt?
English: What are the risks associated with Equioxx?
Danish: Hvilke risici er der forbundet med Equioxx?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Equioxx, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Equioxx, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: The most common side effects with Equioxx (which may affect more than 1 in 10 horses) are ulcers or sores of the lining of the mouth or the skin around the mouth.
Danish: De mest almindelige bivirkninger ved Equioxx (som kan forekomme hos mere end 1 ud af 10 heste) er mavesår eller sår i mundens slimhinde eller huden rundt om munden.
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when giving the product.
Danish: Kvinder i den fødedygtige alder skal undgå kontakt med produktet eller anvende engangshandsker ved håndtering af produktet.
English: Equioxx is available as a solution for injection, an oral paste and chewable tablets.
Danish: Equioxx fås som en opløsning til injektion, oral pasta og tyggetabletter.
English: The most common side effects with Equioxx (which may affect up to 1 in 100 horses) are salivation and lip and tongue swelling associated with the mouth sores.
Danish: De mest almindelige bivirkninger ved Equioxx (som forekommer hos op til 1 ud af 100 heste) er spytflåd, hævelse af læbe og tunge forbundet med mundsår.
English: Equioxx oral paste and Equioxx solution for injection have been studied in a laboratory and found to be bioequivalent.
Danish: Equioxx i oral pastaform og Equioxx som opløsning til injektionsvæske blev undersøgt i et laboratorium og viste sig at være bioækvivalente.
English: Equioxx must not be used in breeding, pregnant or lactating horses.
Danish: Equioxx må ikke anvendes hos avlsheste eller drægtige eller diegivende heste.
English: Similarly Equioxx oral paste and Equioxx chewable tablets have been shown to be bioequivalent.
Danish: Equioxx i oral pastaform og Equioxx som tyggetabletter viste sig også at være bioækvivalente.
English: What benefits of Equioxx have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Equioxx?
English: How is Equioxx used?
Danish: Hvordan anvendes Equioxx?
English: How does Equioxx work?
Danish: Hvordan virker Equioxx?
English: Equioxx must not be used in horses suffering from stomach or gut disorders and bleeding, nor in case of reduced liver, heart or kidney function or bleeding disorders.
Danish: Det må heller ikke anvendes i tilfælde af reduceret lever-, hjerte- eller nyrefunktion eller blødningsforstyrrelser.
English: For more information about treatment with Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Equioxx, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Equioxx, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: This is a summary of the European public assessment report (EPAR) for Thorinane.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Thorinane.
English: The full EPAR for Thorinane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Thorinane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Thorinane is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Thorinane svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Other information about Thorinane
Danish: Andre oplysninger om Thorinane
English: What measures are being taken to ensure the safe and effective use of Thorinane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Thorinane?
English: The Committee recommended that Thorinane be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Thorinane.
English: Why is Thorinane approved?
Danish: Hvorfor blev Thorinane godkendt?
English: The most common side effect with Thorinane (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Thorinane to prevent blood clots during surgery.
Danish: Den hyppigste bivirkning med Thorinane (som kan forekomme hos mere end 1 ud af 10 personer) er blødning; alvorlig blødning er set hos ca. 4 ud af 100 personer, der har fået Thorinane til forebyggelse af blodpropper under operation.
English: In addition, a study in 20 healthy subjects has shown that the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Danish: Derudover har en undersøgelse af 20 raske forsøgspersoner vist, at de samme doser af de to lægemidler givet som indsprøjtning under huden har samme effekt på blodstørkningsfaktorerne, ud fra forskellige værdier, der afspejler, hvordan lægemidlet virker i kroppen.
English: When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart.
Danish: Når der opstår blodpropper inde i blodårerne, kan de forhindre blokere for blodtilstrømningen til organerne, herunder hjertet.
English: What is Thorinane and what is it used for?
Danish: Hvad er Thorinane, og hvad anvendes det til?
English: In the treatment of unstable angina and heart attack Thorinane is given with aspirin (acetylsalicylic acid).
Danish: Ved behandling af ustabil angina pectoris og hjerteanfald gives Thorinane sammen med aspirin (acetylsalicylsyre).
English: Thorinane is a ‘biosimilar medicine'.
Danish: Thorinane er et "biosimilært" lægemiddel.
English: For more information about treatment with Thorinane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Thorinane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Extensive laboratory studies comparing Thorinane with Clexane have shown that Thorinane is highly similar to Clexane in terms of structure, purity and biological activity.
Danish: Omfattende laboratorieundersøgelser, der sammenlignede Thorinane med Clexane, har vist, at Thorinane minder meget om Clexane, hvad angår struktur, renhed og biologisk aktivitet.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Danish: Agenturets Udvalg for Lægemidler til mennesker (CHMP) konkluderede, at der ikke er nogen klinisk betydningsfuld forskel mellem Thorinane og Clexane, hvad angår virkning og sikkerhed, og at fordelene opvejer de identificerede risici som for Clexane.
English: It is not intended to provide practical advice on how to use Thorinane.
Danish: Det er ikke en praktisk vejledning i, hvordan Thorinane bør anvendes.
English: What are the risks associated with Thorinane?
Danish: Hvilke risici er der forbundet med Thorinane?
English: The reference medicine for Thorinane is Clexane.
Danish: Referencelægemidlet for Thorinane er Clexane.
English: Thorinane must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Danish: Thorinane må ikke gives til patienter med eksisterende større blødning, alvorlige problemer med blodpropdannelse eller lidelser, der øger risikoen for blødning eller problemer i forbindelse hermed, f.eks. mavesår eller slagtilfælde.
English: The active substance in Thorinane, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Danish: Det aktive stof i Thorinane, enoxaparin, tilhører gruppen af antikoagulerende (blodfortyndende) midler, der kaldes "lavmolekylære hepariner".
English: Thorinane is an anticoagulant medicine (a medicine to prevent blood clots).
Danish: Thorinane er et antikoagulerende (blodfortyndende) lægemiddel til forebyggelse af blodpropper.
English: Thorinane enoxaparin sodium
Danish: Thorinane enoxaparinnatrium
English: The active substance in Thorinane is enoxaparin sodium.
Danish: Det aktive stof i Thorinane er enoxaparinnatrium.
English: For practical information about using Thorinane, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Thorinane, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Thorinane used?
Danish: Hvordan anvendes Thorinane?
English: For the full list of all side effects reported with Thorinane, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Thorinane fremgår af indlægssedlen.
English: Studies have shown that Thorinane has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Danish: Undersøgelser har vist, at Thorinanes struktur og biologiske aktivitet minder meget om Clexanes, og at de to lægemidler har samme effekt på blodstørkningsfaktorerne.
English: Thorinane is available as a solution for injection in pre-filled syringes.
Danish: Thorinane fås som injektionsvæske i fyldte sprøjter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thorinane have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Thorinane.
English: What benefits of Thorinane have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Thorinane?
English: How does Thorinane work?
Danish: Hvordan virker Thorinane?
English: It contains two different active substances:
Danish: Den indeholder to forskellige aktive stoffer:
English: • you are over 70 years old.
Danish: • De er over 70 år gammel.
English: Number of Days per Week
Danish: Antal dage/uge
English: This means one or more active substances are released slowly over a period of time.
Danish: Det betyder, at et eller flere af de aktive stoffer frigives langsomt over et stykke tid.
English: The majority of the dose was excreted within 96 hours.
Danish: Størstedelen af dosis blev udskilt inden for 96 timer.
English: Your cholesterol problem may return.
Danish: Deres kolesterolproblemer kan vende tilbage.
English: • You are pregnant or plan to become pregnant.
Danish: • De er gravid eller planlægger at blive gravid.
English: This condition requires immediate medical attention.
Danish: Denne tilstand kræver omgående lægehjælp.
English: • you drink large amounts of alcohol.
Danish: • De drikker væsentlige mængder alkohol.
English: Component of a multi-pack, can't be sold separately.
Danish: Del af en multipakning, kan ikke sælges separat.
English: • If you miss a dose, do not take an extra dose.
Danish: • Hvis De glemmer en dosis, skal De ikke tage en ekstra dosis.
English: • Alcohol abuse.
Danish: • Alkoholmisbrug.
English: • You should start by taking one tablet a day.
Danish: • De bør starte med at tage én tablet om dagen.
English: An apparent hypersensitivity reaction has been reported (< 1 %).
Danish: Der er rapporteret om en tilsyneladende hypersensitivitetsreaktion (< 1 %).
English: Your doctor will decide if Pelzont is right for you.
Danish: Lægen vil beslutte, om Pelzont er rigtigt for Dem.
English: • Age > 70 years
Danish: • Alder >70 år.
English: How much to take
Danish: Så meget skal De tage
English: In most people, at first there are no signs of cholesterol problems.
Danish: Hos de fleste mennesker er der i begyndelsen ingen tegn på kolesterolproblemer.
English: What should I know about cholesterol and triglycerides?
Danish: Hvad bør De vide om kolesterol og triglycerider?
English: If you take aspirin for any other reason, continue to follow your doctor's advice.
Danish: Hvis De tager aspirin af andre grunde, skal De fortsat følge lægens råd.
English: In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Danish: I tilfælde af overdosering er det hensigtsmæssigt at anvende de sædvanlige symptomatiske og understøttende forholdsregler.
English: Continue with your usual dose the next evening or at bedtime.
Danish: Fortsæt med den sædvanlige dosis den næste aften eller ved sengetid.
English: • Take Pelzont once a day, in the evening or at bedtime.
Danish: • Tag Pelzont én gang dagligt, om aftenen eller ved sengetid.
English: Weeks on Treatment
Danish: Uger i behandling
English: The name of your medicine is Pelzont.
Danish: Navnet på Deres medicin er Pelzont.
English: • It is important to follow the advice given in section 3 How to take Pelzont.
Danish: • Det er vigtigt, at De følger vejledningen i afsnit 3 Sådan skal De tage Pelzont.
English: In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Pelzont.
Danish: Desuden er en eller flere af følgende symptomer set som del af en allergisk reaktion over for Pelzont.
English: Tell your doctor about all of your medical conditions.
Danish: Fortæl lægen om Deres helbredstilstand.
English: • when you cannot tolerate a statin or when a statin is not recommended for you.
Danish: • når De ikke kan tåle et statin, eller når De ikke bør få et statin.
English: Some people get dizzy after taking Pelzont.
Danish: Nogle mennesker kan føle sig svimle, efter de har taget Pelzont.
English: Blood tests and monitoring
Danish: Blodprøver og kontrol
English: • decreased glucose (sugar) tolerance
Danish: • Nedsat glucose-(sukker)tolerance
English: Laropiprant crosses the placenta in rats and rabbits.
Danish: Laropiprant passerer placenta hos rotter og kaniner.
English: PVC/Aclar blisters: 2 years.
Danish: PVC/Aclar blister: 2 år.
English: Adjustment of diet and/or hypoglycaemic therapy may be necessary.
Danish: Justering af diæt og/eller hypoglykæmisk behandling kan være nødvendig.
English: Periodic serum creatine kinase (CK) should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.
Danish: Periodisk serumkreatinkinase (CK) bør overvejes i sådanne situationer, men der er ingen sikkerhed for, at monitorering vil forhindre forekomst af svær myopati.
English: Pelzont with food, drink and alcohol
Danish: Brug af Pelzont sammen med mad, drikke og alkohol
English: • a sudden serious allergic reaction (anaphylactic shock).
Danish: • En pludselig alvorlig allergisk reaktion (anafylaktisk shock).
English: • you have any allergies.
Danish: • De har allergi.
English: Daily doses greater than 2,000 mg/40 mg have not been studied and therefore are not recommended.
Danish: Daglige doser over 2.000 mg/40 mg er ikke undersøgt og bør derfor ikke anvendes.
English: Liver function tests are recommended before initiation, every 6 to 12 weeks for the first year, and periodically (e.g. semi-annually) thereafter.
Danish: Leverfunktionsprøver anbefales før behandlingsstart, hver 6.-12. uge i det første år og derefter periodisk (f.eks. halvårligt).
English: Efficacy and safety of Pelzont in combination with simvastatin > 40 mg were not included in this study.
Danish: Pelzonts sikkerhed og effekt i kombination med simvastatin > 40 mg var ikke inkluderet i denne undersøgelse.
English: Rare: rhinitis
Danish: Sjælden: rhinitis
English: Laropiprant is highly bound (> 99 %) to plasma proteins, and its binding is independent of concentration.
Danish: Laropiprant er i høj grad (> 99%) bundet til plasmaproteiner, og dets binding er uafhængig af koncentrationen.
English: It is not known if Pelzont will harm your unborn baby.
Danish: Det er ukendt, om Pelzont kan skade Deres ufødte barn.
English: • In the event of an overdose, the following side effects were reported:
Danish: • I forbindelse med overdosis har man set følgende bivirkninger: