FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have problems with your sight or any other eye problems when you are using Tegsedi, you should speak to your doctor.
Danish: Fortæl det til din læge, hvis du har problemer med synet eller andre øjenproblemer, mens du får Tegsedi.
English: Do not throw away the pre-filled syringe in your household waste.
Danish: Smid ikke den fyldte injektionssprøjte ud sammen med husholdningsaffaldet.
English: Glomerulonephritis/ renal function decline
Danish: Glomerulonefritis/forringelse af nyrefunktionen
English: PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY TEAR-OFF LID
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP AFRIVELIGT LÅG PÅ BAKKE
English: Tegsedi has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Tegsedi påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: NAME OF THE MEDICINAL PRODUCT Tegsedi 284 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Tegsedi 284 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Influenza like illness Peripheral swelling Injection site discolouration
Danish: Influenzalignende sygdom Perifer hævelse
English: Do not pull the plunger up by hand.
Danish: Træk ikke stemplet op manuelt.
English: • Advise HCPs that if the platelet count falls below 25 x 109/L, Tegsedi treatment should be permanently discontinued and corticosteroid therapy is recommended;
Danish: • Tilråde læger og sundhedspersonale, at behandling med Tegsedi seponeres permanent, og at behandling med kortikosteroider anbefales, hvis trombocyttallet falder til under 25 x 109/l
English: Special caution should be used in elderly patients, in patients taking anithrombotic medicinal products, antiplatelet medicinal products, or medicinal products that may lower platelet count (see section 4.5), and in patients with prior history of major bleeding events.
Danish: Der skal udvises særlig forsigtighed i forbindelse med ældre patienter, patienter, der får antitrombotika, antitrombotiske lægemidler eller lægemidler, der kan sænke trombocyttallet (se pkt.
English: Insert the needle
Danish: Indføring af kanylen
English: ‡ Additional risk factors for bleeding include age >60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events † It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline.
Danish: ‡ Yderligere risikofaktorer for blødning omfatter alder > 60 år, behandling med antikoagulantia eller antitrombotiske lægemidler og/eller tidligere tilfælde af væsentlige blødningshændelser.
English: Chills
Danish: Kanyle
English: Remove the needle cap
Danish: Tag kanylehætten af
English: Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia (see section 4.8).
Danish: Inotersen er forbundet med fald i trombocyttal, hvilket kan medføre trombocytopeni (se pkt.
English: Do not let go of the plunger.
Danish: Slip ikke stemplet.
English: Tegsedi may reduce cells in the blood responsible for clotting of the blood (platelets), which may result in a condition called thrombocytopenia (see section 4).
Danish: Tegsedi kan reducere antallet af de celler i blodet, som størkner blodet (blodplader).
English: If you are using any medicines that damage the kidney or affect kidney function, for example sulfonamides, aldosterone antagonists, and some types of painkillers, you should tell your doctor.
Danish: Fortæl det til din læge, hvis du bruger medicin, som kan beskadige nyrerne eller påvirke nyrefunktionen, for eksempel sulfonamider, aldosteronantagonister og visse typer smertestillende midler.
English: Bend and snap
Danish: Nyrer og urinveje
English: If any of the above happens, throw away the pre-filled syringe in a puncture-resistant (sharps) container and use a new pre-filled syringe.
Danish: Kassér den fyldte injektionssprøjte i en kanylebøtte, hvis noget af ovenstående sker, og brug en ny, fyldt injektionssprøjte.
English: In the Phase 3, NEURO-TTR trial, platelet count reductions to below normal (140 x 109/L ) were observed in 54% of patients treated with inotersen and 13% of placebo patients; reductions to below 100 x 10
Danish: I fase 3 NEUROTTR-forsøget blev der observeret fald i trombocyttal til under normalområdet (140 x 10
English: Remove needle cap by pulling it straight off. Do not twist it off.
Danish: Fjern kanylehætten ved at trække den lige af.
English: What you need to know before you use Tegsedi Do not use Tegsedi if: - you are allergic to inotersen or any of the other ingredients of this medicine (listed in section - tests show you have excessively low numbers of platelets, the cells in your blood which stick together helping it clot - tests of kidney function or protein in the urine show signs of severe kidney problems - you have severe reduction in liver function (hepatic impairment) Warnings and precautions Before you begin treatment with Tegsedi, your doctor will measure your blood cells, liver function, kidney function, and protein levels in your urine.
Danish: - hvis du har fået taget prøver, der viser usædvanligt lave antal blodplader, som er de celler i blodet, der klæber sammen for at få blodet til at størkne - hvis undersøgelser af nyrefunktionen eller protein i urinen viser tegn på alvorlige nyreproblemer - hvis du har svært nedsat leverfunktion (leverinsufficiens)
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected.
Danish: Indholdet må ikke injiceres, hvis opløsningen er grumset eller indeholder synlige partikler.
English: Do not pull the cap off while holding the pre-filled syringe by the plunger.
Danish: Hold ikke på den fyldte injektionssprøjtes stempel, mens du trækker hætten af.
English: INJECTION 6.
Danish: Virkning og anvendelse 2.
English: If the solution looks cloudy, discoloured or has particles, throw the pre-filled syringe away in a puncture resistant (sharps) container, and use a new pre-filled syringe.
Danish: Kassér den fyldte injektionssprøjte i en kanylebøtte, hvis opløsningen er grumset, misfarvet eller indeholder partikler, og brug en ny, fyldt injektionssprøjte.
English: 9/L; one of these patients experienced a fatal intracranial haemorrhage.
Danish: Tre (3 %) patienter udviklede trombocyttal på < 25 x 109/l; den ene af disse patienter fik en letal intrakraniel blødning.
English: Do not put the needle cap back onto the pre-filled syringe.
Danish: Sæt ikke kanylehætten på den fyldte injektionssprøjte igen.
English: Platelet count < 100 x 10
Danish: Fald til under 100 x 10
English: Keep your hands away from the plunger to avoid pushing the plunger before you are ready to inject.
Danish: Hold hænderne på afstand af stemplet, så du undgår at skubbe stemplet ind ved en fejl, før du er klar til at injicere.
English: If glomerulonephritis is excluded, dosing may be resumed if clinically indicated and following improvement of renal function (see section 4.3).
Danish: Doseringen kan genoptages efter klinisk behov og efter at nyrefunktionen er forbedret, hvis glomerulonefritis kan udelukkes (se pkt.
English: How to use Tegsedi
Danish: Sådan skal du bruge Tegsedi
English: Patients should be monitored for signs of increased proteinuria and reduction in eGFR during treatment with inotersen (see section 4.4).
Danish: Glomerulonefritis/forringelse af nyrefunktionen Patienterne skal monitoreres for tegn på øget proteinuri og fald i eGFR under behandling med inotersen (se pkt.
English: If you are taking any medicines that can lower platelet count or stop blood from clotting, for example acetylsalicylic acid, clopidogrel, warfarin, heparin, rivoraxaban and dabigatran, you must tell your doctor before you use Tegsedi.
Danish: Fortæl det til din læge, inden du bruger Tegsedi, hvis du tager medicin, som kan sænke antallet af blodplader eller forhindre blodet i at størkne, for eksempel acetylsalicylsyre, clopidogrel, warfarin, heparin, rivoraxaban og dabigatran.
English: (haematoma) - Itching - Rash - Kidney damage leading to poor kidney function or kidney failure - Changes to your blood and urine test results (this may indicate infection or liver or kidney damage) - Flu like symptoms, such as high temperature, aches and chills (influenza-like illness) - Injection site swelling or skin discolouration
Danish: (eosinofili) - Nedsat appetit - En følelse af at skulle besvime eller svimmelhed, især når du rejser dig op (lavt blodtryk) - Blå mærker - Ansamling af blod i vævet, som kan ligne kraftige blå mærker (hæmatom) - Kløe - Udslæt - Nyreskade, som kan føre til dårlig nyrefunktion eller nyresvigt - Ændringer i resultater af blod- og urinprøver.
English: When the plunger comes to a stop, your injection is complete.
Danish: Injektionen er færdig, når stemplet stopper.
English: Injection site reactions Peripheral oedema
Danish: Reaktioner på injektionsstedet Perifert ødem
English: SC
Danish: TTR
English: Posology
Danish: KLARGØRING
English: Body
Danish: Administration
English: PREPARATION
Danish: Opbevaring
English: Three (3%) patients developed platelet counts < 25 x 10
Danish: Der blev observeret bekræftede trombocyttal på < 75 x 10
English: This summary was last updated in December 2013.
Danish: Dette sammendrag blev sidst ajourført i december 2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Contacera on 6 December 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Contacera den 6. december 2012.
English: Other information about Contacera:
Danish: Andre oplysninger om Contacera:
English: If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
Danish: Hvis en person utilsigtet injicerer sig selv med lægemidlet, skal der straks søges lægehjælp.
English: People who are hypersensitive to NSAIDs should avoid contact with Contacera.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med Contacera.
English: Therefore the CVMP's view was that, as for Metacam, Contacera's benefits are greater than its risks when used for the approved indications and the Committee recommended that Contacera be given a marketing authorisation.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Contacera - ligesom Metacam - er større end risiciene, når det anvendes til de godkendte indikationer, og udvalget anbefalede udstedelse af markedsføringstilladelse for Contacera.
English: It is available as a solution for injection (20 mg/ml) and an oral suspension (15 mg/ml).
Danish: Det fås som en opløsning til injektion (20 mg/ml) og en oral suspension (15 mg/ml).
English: Contacera is a medicine that contains the active substance meloxicam.
Danish: Contacera er et lægemiddel, der indeholder det aktive stof meloxicam.
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Danish: Det må ikke gives til dyr, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: Contacera contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Contacera indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikke-steroide antiinflammatoriske lægemidler (NSAID'er).
English: The product is not authorised for use in horses producing milk for human consumption.
Danish: Lægemidlet må ikke anvendes til heste, som producerer mælk til menneskeligt konsum.
English: What is the risk associated with Contacera?
Danish: Hvilken risiko er der forbundet med Contacera?
English: It can be used for the relief of postoperative pain following dehorning in calves.
Danish: Det kan anvendes til lindring af postoperative smerter ved afhorning af kalve.
English: Contacera is a ‘generic', which means that Contacera is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Danish: Contacera er et generisk lægemiddel, hvilket betyder, at Contacera svarer til et "referenceveterinærlægemiddel", som allerede er godkendt i EU (Metacam).
English: Why has Contacera been approved?
Danish: Hvorfor blev Contacera godkendt?
English: The CVMP considered that, in accordance with European Union requirements, Contacera has been shown to be bioequivalent to Metacam.
Danish: CVMP vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Contacera er bioækvivalent med Metacam.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically.
Danish: Der kan i meget sjældne tilfælde forekomme potentielt alvorlige eller dødelige anafylaktoide reaktioner (svarende til stærk overfølsomhed) efter injektion, og disse skal behandles symptomatisk.
English: A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Danish: Der blev observeret en let og forbigående hævelse på injektionsstedet efter injektion under huden hos kvæg og svin.
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 cyklooxygenase, der medvirker ved dannelsen af prostaglandiner.
English: It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Danish: Det er også den tid, der skal gå efter indgivelsen af lægemidlet, før mælken kan anvendes til menneskeligt konsum.
English: What is Contacera used for?
Danish: Hvad anvendes Contacera til?
English: For meat the withdrawal period with the 20 mg/ml solution for injection is five days and with the 15 mg/ml oral suspension it is three days.
Danish: Tilbageholdelsestiden for kød i forbindelse med opløsningen til injektion, 20 mg/ml, er fem dage, og for den orale suspension, 15 mg/ml, er den tre dage.
English: Consequently, Contacera's benefit is taken as being the same as that of the reference medicine.
Danish: Derfor anses fordelene ved Contacera for at være de samme som referencelægemidlets.
English: Contacera must not be used in horses less than six weeks of age or in cattle less than one week of age when used in the treatment of diarrhoea.
Danish: Contacera må ikke anvendes til behandling af diarré hos heste, der er mindre end seks uger gamle, eller til kvæg, der er mindre end en uge gamle.
English: Since Contacera is a generic medicine, studies have been conducted to show that Contacera has the same characteristics as the reference medicine, Metacam.
Danish: Da Contacera er et generisk lægemiddel, er undersøgelserne blevet udført med henblik på at påvise, at Contacera har samme karakteristika som referencelægemidlet Metacam.
English: Contacera should not be used in pregnant or lactating mares but it can be used during pregnancy and lactation for cattle and pigs.
Danish: Contacera bør ikke anvendes til drægtige eller diegivende hopper, men hos kvæg og svin kan det anvendes under drægtighed og diegivning.
English: For meat the withdrawal period is 15 days and for milk it is five days.
Danish: Tilbageholdelsestiden er 15 dage for kød og fem dage for mælk.
English: For meat the withdrawal period is five days.
Danish: Tilbageholdelsestiden er fem dage for kød.
English: Contacera must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Danish: Contacera må ikke anvendes til dyr med lever-, hjerte- og nyreproblemer, blødningsforstyrrelser eller som lider af irritation eller sår i fordøjelseskanalen.
English: It can be used for diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle.
Danish: Det kan anvendes ved diarré i kombination med oral tilførsel af vand (lægemidler, der indgives gennem munden for at genoprette vandbalancen i kroppen) med henblik på at mindske kliniske sygdomstegn hos kalve, der er mere end én uge gamle, og hos ungkvæg, som ikke er diegivende.
English: How has Contacera been studied?
Danish: Hvordan blev Contacera undersøgt?
English: Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine.
Danish: På grundlag af undersøgelsesresultaterne blev Contacera betragtet som bioækvivalent med referencelægemidlet.
English: In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan der forekomme en forbigående hævelse på injektionsstedet, der forsvinder af sig selv.
English: In pigs, Contacera is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Danish: Hos svin anvendes Contacera til at reducere symptomerne på halten og betændelse i forbindelse med ikke-smittefarlige sygdomme i bevægeapparatet (sygdomme, som påvirker bevægelsesevnen) og som støttebehandling i kombination med passende antibiotikabehandling til behandling af sygdomme, der opstår efter faring, såsom puerperal septikæmi og toksæmi (mastitis-metritis-agalactia-syndrom).
English: Side effects that occurred with the oral suspension in horses included isolated cases of adverse reactions typically associated with NSAIDs (slight urticaria and diarrhoea).
Danish: I forbindelse med den orale suspension til heste er der indberettet enkeltstående tilfælde af bivirkninger, som typisk er forbundet med NSAID'er (let urticaria og diarré).
English: Contacera is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Danish: Contacera anvendes til kvæg i kombination med passende antibiotikabehandling for at mindske de kliniske sygdomstegn på akut respiratorisk infektion (infektion i lunger og luftveje) og til behandling af akut mastitis (yverbetændelse).
English: What is Contacera?
Danish: Hvad er Contacera?
English: What benefit has Contacera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Contacera?
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
Danish: I meget sjældne tilfælde blev der indberettet nedsat appetit, letargi, mavesmerter og tyktarmsbetændelse.
English: In horses, Contacera is used for the relief of pain associated with colic (abdominal pain) and for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Danish: Hos heste anvendes Contacera til lindring af smerter forbundet med kolik (mavesmerter) og til lindring af betændelse og smerter ved såvel akutte som kroniske muskel- og knoglelidelser.
English: How does Contacera work?
Danish: Hvordan virker Contacera?
English: The treatment will be repeated every 3 weeks.
Danish: Behandlingen skal gentages hver 3. uge.
English: The possibility of genetic counselling should be considered.
Danish: Muligheden for genetisk rådgivning bør overvejes.
English: Recent (within 2 weeks) or current severe infection.
Danish: Nylig (inden for 2 uger) eller aktuel svær infektion.
English: Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
Danish: Dato for første markedsføringstilladelse: 21. september 2009 Dato for seneste fornyelse: 16. maj 2014
English: You should also drink water and eat high fibre foods.
Danish: Du skal også drikke vand og spise mad med højt fiberindhold.
English: Therefore, caution should be excercised when this type of combination is used.
Danish: Derfor bør der udvises forsigtighed, når denne form for kombination anvendes.
English: It is most unlikely that you will be asked to store this medicine yourself.
Danish: Det er meget usandsynligt, at du vil blive bedt om at opbevare denne medicin.
English: However a statistically significant effect was seen on progression-free survival.
Danish: Der kunne imidlertid ses en statistisk signifikant effekt på den progressionsfri overlevelse (PFS).
English: Intrathecal administration of Javlor may be fatal.
Danish: Intratekal administration af Javlor kan være fatal.
English: This is considered the most relevant population for the efficacy analysis, as it most closely reflects the population intended for treatment.
Danish: Dette anses for at være den mest relevante population for effektanalysen, da den bedst afspejler den påtænkte population til behandling.
English: All cases resolved rapidly without treatment discontinuation.
Danish: Alle tilfælde forsvandt hurtigt uden afbrydelse af behandlingen.
English: There are no data available on the use of vinflunine in pregnant women.
Danish: Der er ingen data fra anvendelse af vinflunin til gravide kvinder.
English: The use of gloves, goggles and protective clothing is recommended.
Danish: Det anbefales at anvende handsker, sikkerhedsbriller og beskyttelsestøj.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under punkt 6.6.
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Danish: Genetisk rådgivning anbefales også til patienter, der ønsker at få børn efter behandlingen.
English: Therefore, risks of clinically significant interactions should be unlikely.
Danish: Derfor er det usandsynligt, at der forekommer klinisk signifikante interaktioner.
English: To avoid extravasations it is important to be sure that the needle is correctly introduced before starting the infusion.
Danish: For at undgå ekstravasationer er det vigtigt at være sikker på, at nålen er ført rigtigt ind, inden infusionen startes.
English: See Section 4.
Danish: Se afsnit 4.
English: Organ toxicity: moderate, severe or life threatening
Danish: Organtoksicitet: moderat, alvorlig eller livstruende
English: Javlor with food and drink
Danish: Brug af Javlor sammen med mad og drikke
English: Pregnant staff should not handle Javlor.
Danish: Ansatte, som er gravide, bør ikke håndtere Javlor.
English: You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor.
Danish: Du skal tale med din læge, hvis du drikker grapefrugtjuice, da det kan forstærke virkningen af Javlor.
English: Day 1 treatment administration
Danish: Dag 1 administration af behandling
English: These toxic effects were dose-related and fully or-partially reversible following a 1-month recovery period.
Danish: Disse toksiske effekter var dosisrelaterede og helt eller delvist reversible efter en restitutionsperiode på 1 måned.
English: It is unknown whether vinflunine or its metabolites are excreted in human milk.
Danish: Det er uvist, om vinflunin eller dets metabolitter udskilles i human mælk.
English: However, this combination was associated with a particularly high risk of haematological toxicity.
Danish: Denne kombination var imidlertid forbundet med en særlig høj risiko for hæmatologisk toksicitet.
English: Each pack contains 1 or 10 vials.
Danish: Hver pakning indeholder 1 eller 10 hætteglas.
English: Javlor must not be given intrathecally (into the spine).
Danish: Javlor må ikke gives intratekalt (i rygraden).
English: First Event
Danish: Første hændelse