FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: Hjælpestofferne anført under afsnit 6.1 i SPCet er enten tilladte hjælpestoffer hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Danish: Overdosering (symptomer, nødforanstaltninger, modgift): I tilfælde af overdosering bør symptomatisk behandling initieres.
English: Cardboard box containing one high density polyethylene (HDPE) bottle of 125 ml or 336 ml with a HDPE screw cap and a polypropylene measuring syringe.
Danish: Karton indeholdende en polyethylenflaske med 125 ml eller 336 ml med polyethylenskruelåg og en doseringssprøjte af polyethylen.
English: HDPE-bottle
Danish: HDPE-flaske
English: To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
Danish: Skal indgives enten tilsat en lille mængde foder, som gives lige inden fodring eller direkte i munden.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Danish: Meloxicam Meloxicam Kreaturer, geder, grise, kanin, dyr af hestefamili en
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Danish: Hvis der forekommer bivirkninger bør behandlingen afbrydes og dyrlægen kontaktes.
English: Active substance Meloxicam 15 mg.
Danish: Aktivt stof Meloxicam 15 mg.
English: Hydroxyethylcellulose Silica, colloidal anhydrous Disodium phosphate dodecahydrate Citric acid monohydrate Sodium cyclamate Sorbitol, liquid
Danish: Hydroxyethylcellulose Silica, kolloid vandfri Dinatriumphosphatdihydrat Citronsyremonohydrat Natriumcyclamat
English: Suomi/Finland Dechra Veterinary Products Oy Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Sweden
Danish: Dechra Veterinary Products Oy Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Sweden
English: Shelf-life after first opening of the immediate packaging: 5 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 5 måneder.
English: Do not use after the expiry date stated on the carton and the bottle after EXP.
Danish: Opbevaringstid efter første åbning af beholderen: 6 måneder Må ikke anvendes efter den udløbsdato, som er angivet på æsken og flasken efter EXP.
English: Withdrawal period(s):
Danish: Tilbageholdelsestid(er):
English: EXP (month/year) Once broached, use by ……….
Danish: EXP {MM/ÅÅÅÅ} Efter åbning anvendes inden…..
English: Novaquin 15 mg/ml oral suspension for horses
Danish: Novaquin 15 mg/ml oral suspension til heste
English: Excipients Sodium benzoate 1.75 mg
Danish: Hjælpestof Natriumbenzoat 1,75 mg
English: Yellowish-green viscous oral suspension.
Danish: Gullig-grøn tyktflydende oral suspension
English: Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Danish: Enkeltstående tilfælde af typiske non-steroide antiinflammatoriske bivirkninger (NSAID-præparater) er observeret i kliniske undersøgelser (let nældefeber, diarré).
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Danish: Særlige forsigtighedsregler for personer, som indgiver veterinærlægemidlet til dyr: Personer med kendt overfølsomhed over for NSAID-præparater bør undgå kontakt med veterinærlægemidlet.
English: Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Danish: Interaktioner med andre lægemidler og andre former for interaktion Må ikke indgives samtidig med glucocortikosteroider, andre NSAID-præparater eller antikoagulantia.
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ved overfølsomhed over for non-steroide antiinflammatoriske lægemidler (NSAID-præparater) bør kontakt med lægemidlet undgås.
English: Marketing authorisation holder: Le Vet Pharma B.V.
Danish: Indehaver af markedsføringstilladelsen Le Vet Beheer B.V.
English: EXP {month/year} Shelf-life of opened bottle: 5 months.
Danish: EXP {MM/ÅÅÅÅ} Holdbarhed efter åbning: 5 måneder.
English: Novaquin 15 mg/ml oral suspension for horses meloxicam
Danish: Novaquin 15 mg/ml oral suspension til heste meloxicam
English: Active substance: Meloxicam
Danish: Aktivt stof: Meloxicam 15 mg
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Excipient: Sodium benzoate
Danish: Natriumbenzoat Glycerol
English: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Danish: Må ikke gives samtidig med glucocortikosteroider, andre NSAID-præparater eller antikoagulantia.
English: Not all pack sizes may be marketed.For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette lægemiddel.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Produlab Pharma B.V.
English: Do not use in pregnant or lactating mares.
Danish: Må ikke anvendes til drægtige eller diegivende hopper.
English: Outer carton
Danish: Ydre emballage
English: 2 July 2012
Danish: Den 2. juli 2012
English: 1 Revlimid is marketed in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece Ireland, Italy, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Danish: 1 Revlimid markedsføres i Østrig, Belgien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Malta, Nederlandene, Polen, Portugal, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: Revlimid has been authorised in the European Union (EU) since 14 June 2007 and is marketed in 21 EU Member States1.
Danish: Revlimid har været godkendt i EU siden den 14. juni 2012 og markedsføres i 21 EU-medlemsstater1.
English: The applicant presented data from two main studies involving 1073 patients with newly diagnosed multiple myeloma.
Danish: Ansøgeren fremlagde data fra to hovedundersøgelser, hvori der deltog 1 073 patienter med nydiagnosticeret multipelt myelom.
English: Revlimid is an anticancer medicine.
Danish: Revlimid er et lægemiddel mod kræft.
English: What is Revlimid?
Danish: Hvad er Revlimid?
English: The full European Public Assessment Report for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Revlimid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is happening with Revlimid for the treatment of multiple myeloma?
Danish: Hvad vil der ske med brugen af Revlimid til behandling af multipelt myelom?
English: The letter from the company notifying the Agency of the withdrawal of the application is available here.
Danish: Virksomhedens brev til agenturet med meddelelsen om tilbagetrækningen kan ses her.
English: The active substance in Revlimid, lenalidomide, is an immunomodulating agent.
Danish: Det aktive stof i Revlimid, lenalidomid, er et immunmodulerende middel.
English: On 20 June 2012, Celgene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Revlimid, to extend its use to the treatment of patients with newly diagnosed multiple myeloma.
Danish: Den 20. juni 2012 meddelte Celgene Europe Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af markedsføringstilladelsen for Revlimid med henblik på tilføjelse af behandling af nydiagnosticeret multipelt myelom.
English: Therefore, more mature survival data and follow-up would be needed to conclude on the benefit-risk balance for this indication.
Danish: Det er derfor nødvendigt med mere fuldstændige data og opfølgning, før der kan drages konklusioner om benefit/risk-forholdet for denne anvendelse.
English: The company informed the CHMP that clinical trials or compassionate use programmes will not be interrupted and patients will continue to be carefully monitored with respect to overall survival and development of new cancers.
Danish: Virksomheden underrettede CHMP om, at kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse ikke vil blive afbrudt, og at patienterne fortsat vil blive nøje overvåget hvad angår samlet overlevelse og opståen af nye kræfttilfælde.
English: In newly diagnosed multiple myeloma, Revlimid was expected to work in the same way as it does in its existing indication.
Danish: Ved nydiagnosticeret multipelt myelom forventedes Revlimid at virke på samme måde som det gør til den eksisterende anvendelse.
English: The second study compared Revlimid with placebo in patients who had received an autologous stem cell transplant.
Danish: I den anden undersøgelse blev Revlimid sammenlignet med placebo hos patienter, der havde fået en autolog stamcelletransplantation.
English: What was Revlimid expected to be used for?
Danish: Hvad forventedes Revlimid anvendt til?
English: Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
Danish: Lenalidomid virker på flere forskellige måder ved multipelt myelom: Det blokerer for kræftcellernes vækst, forhindrer karvækst i svulsterne og stimulerer desuden forskellige specialiserede celler i immunsystemet til at angribe kræftcellerne.
English: Revlimid was also expected to be used for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with Revlimid, melphalan, and prednisone (other medicines to treat multiple myeloma), or following autologous stem cell transplant (a transplant of the patient's own blood-producing cells).
Danish: Revlimid forventedes yderligere anvendt til vedligeholdelsesbehandling af nydiagnosticeret multipelt myelom, der ikke er skredet frem efter indledende behandling med Revlimid, melfalan og prednison (andre lægemidler til behandling af multipelt myelom), eller efter autolog stamcelletransplantation (transplantation af patientens egne bloddannende celler).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Revlimid findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far require follow-up with more mature data to allow the Committee to reach a clear conclusion on the benefit-risk balance.
Danish: I sit officielle brev angav virksomheden, at den havde besluttet at trække ansøgningen tilbage på baggrund af CHMP's holdning, dvs. at de forelagte data kræver opfølgning med mere fuldstændige data, før udvalget kan drage en klar konklusion om benefit/risk-forholdet.
English: It is used in combination with dexamethasone (an antiinflammatory medicine) to treat adults with multiple myeloma whose disease has been treated at least once in the past (second-line treatment).
Danish: Det anvendes i kombination med dexamethason (et antiinflammatorisk lægemiddel) til behandling af voksne med multipelt myelom, når sygdommen i forvejen er blevet behandlet mindst én gang (dvs. andetvalgsbehandling).
English: There are no consequences on the use of Revlimid in its authorised indication, as Revlimid has a positive benefit-risk balance when used in patients with multiple myeloma who have already had one or more other types of treatment before2.
Danish: Tilbagetrækningen får ingen ingen konsekvenser for anvendelsen af Revlimid til den godkendte indikation, da Revlimid har et positivt benefit /risk-forholdet ved anvendelse hos patienter med multipelt myelom, som i forvejen har fået en eller flere andre typer behandlinger2.
English: Furthermore, since Revlimid was associated with an increased risk of developing new cancers, the CHMP could not rule out that the lack of a longer survival could be due to death caused by new cancers.
Danish: Da Revlimid er forbundet med øget risiko for opståen af nye kræfttilfælde, fandt CHMP desuden, at det ikke kunne udelukkes, at den manglede forbedring i overlevelse skyldtes nye kræfttilfælde.
English: The main measure of effectiveness was how long the patients survived without their disease getting worse.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden at deres sygdom forværredes.
English: Revlimid was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 12 December 2003 for multiple myeloma.
Danish: Revlimid blev udpeget som ”lægemiddel til sjældne sygdomme” den 12. december 2003 til behandling af multipelt myelom.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser Revlimid eller i programmer for anvendelse af Revlimid med særlig udleveringstilladelse?
English: How is Revlimid expected to work?
Danish: Hvordan forventes Revlimid at virke?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Revlimid in newly diagnosed multiple myeloma patients did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Revlimid ved nydiagnosticeret multipelt myelom ikke var tilfredsstillende påvist, og at fordelene ikke er større end risiciene.
English: In the first study, patients were given melphalan and prednisone together with either Revlimid or placebo (a dummy treatment) during an initial phase, followed by a maintenance phase where patients received Revlimid or placebo.
Danish: I den første undersøgelse fik patienterne i en indledende fase melfalan og prednison sammen med enten Revlimid eller placebo (virkningsløs behandling).
English: The Committee was concerned that, while there was a clear benefit in terms of delaying the progression of the disease in newly diagnosed multiple myeloma patients, this did not lead to a meaningful improvement of symptoms and longer survival.
Danish: Udvalget fandt der betænkeligt, at der trods klare fordele gennem forsinkelse af sygdommens fremadskriden ikke var opnået meningsfuld bedring i symptomer eller forbedret overlevelse ved nydiagnosticeret multipelt myelom.
English: This study looked at how long patients survived after the transplant without their disease getting worse.
Danish: I denne undersøgelse blev behandlingens virkning hovedsagelig bedømt på, hvor længe patienterne overlevede uden at sygdommen forværredes.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Revlimid could not have been approved to treat newly diagnosed multiple myeloma patients.
Danish: På tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder på baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål.
English: Before you start
Danish: Før du begynder
English: • 10 seconds has passed,
Danish: • Der er gået 10 sekunder,
English: These must NEVER be re-used.
Danish: De må ALDRIG genbruges.
English: Not known (frequency cannot be estimated from available data):
Danish: Ikke kendt (hyppighed kan ikke vurderes ud fra tilgængelige data):
English: Age over 65 years
Danish: Ældre over 65 år
English: The highest frequency seen among the various indications has been included.
Danish: Den højeste hyppighed, der er set i forbindelse med de forskellige indikationer, er anført.
English: They will also tell you the prescribed amount (volume).
Danish: De vil også fortælle dig, hvor meget du skal give (mængde).
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Danish: De primære non-respondenter blev ekskluderet fra studierne, og derfor blev disse patienter ikke yderligere undersøgt.
English: This step is important to get the proper dose.
Danish: Dette er vigtigt for at kunne udtage den korrekte dosis.
English: Component of a multipack, can't be sold separately.
Danish: Dele af multipakning, må ikke sælges separat.
English: • A 2nd “CLICK” is heard,
Danish: • Du hører ”KLIK” nummer 2,
English: Maintenance Dose Starting at week 4
Danish: Vedligeholdelsesdosis startende ved uge 4
English: Double-Blind Response at week 12
Danish: Dobbeltblind respons ved uge 12
English: Be careful that it does not fall over.
Danish: Pas på, at det ikke vælter.
English: Hulio can also be given alone.
Danish: Hulio kan også anvendes alene.
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Danish: PGA-F clear/minimal og ≥2-grad forbedring (%)
English: Each pack contains:
Danish: En pakning indeholder:
English: It is also normal to see air bubble(s).
Danish: Det er også normalt at se luftbobler.
English: • impotence.
Danish: • impotens.
English: 61352 Bad Homburg v. d. Höhe Germany
Danish: 61352 Bad Homburg v. d. Höhe Tyskland
English: • DO NOT touch the Orange Activator with your fingers (this is where the needle comes out).
Danish: • RØR IKKE den orange aktiveringsdel med fingrene (det er her kanylen kommer ud).
English: Components inside the pen may be broken.
Danish: De indvendige dele i pennen kan være blevet beskadiget.
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table 13).
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (tabel 13).
English: Make sure you know the prescribed amount .
Danish: Vær sikker på, at du kender den korrekte mængde.
English: ASASa Partial Remission
Danish: ASASa delvis remission
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor skal benefit/risk-balancen ved behandling tages meget nøje i betragtning.
English: • Stevens-Johnson syndrome;
Danish: • Stevens-Johnsons syndrom;
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Danish: BCVA blev enten forbedret eller vedligeholdt (<5 forringelse i forhold til bogstaver) i 88,4% af øjnene ved uge 78.
English: Clinical results were assessed for induction of remission at week 8 and for maintenance of remission at week 52.
Danish: De kliniske resultater blev vurderet for induktion af remission ved uge 8 og for vedligeholdelse af remission ved uge 52.
English: You should continue to inject Hulio for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Hulio så længe, din læge har sagt.
English: • dry eyes, dry mouth;
Danish: • tørre øjne, tør mund;
English: The educational program consists of a Patient Reminder Card.
Danish: Uddannelsesprogrammet består at et patientkort.
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Danish: Rapporterne indeholder tilfælde af lungetuberkulose og ekstra-pulmonal (dvs. dissemineret) tuberkulose.
English: Week 24 BASDAIb 50
Danish: Uge 24 BASDAIb 50
English: You will set the volume to the prescribed dose in a later step.
Danish: Du skal indstille dosis til den foreskrevne mængde på et senere trin.
English: • sensation of heart beating rapidly;
Danish: • fornemmelse af at hjertet slår hurtig;
English: ASAS Partial Remission BASDAIb 50
Danish: ASAS delvis remission BASDAIb 50
English: Monoclonal antibodies are proteins that attach to specific target in the body.
Danish: Monoklonale antistoffer er proteiner, som binder til et bestemt mål i kroppen.
English: Read the instructions carefully and follow them step by step.
Danish: Læs venligst vejledningen grundigt, og følg den trin for trin.
English: Hulio contains sodium and sorbitol
Danish: Hulio indeholder natrium og sorbitol
English: • In some patients the body may fail to produce enough of the blood cells that fight infections or help you to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som hjælper kroppen med at bekæmpe infektioner eller stoppe blødninger.
English: • swollen face, hands or feet;
Danish: • hævelse af ansigt, hænder eller fødder;
English: Clinical remission 12% 24%
Danish: Klinisk remission 12% 24%
English: Table 25: Maintenance regimen
Danish: Tabel 25: Vedligeholdelsesregime
English: If retreatment with Hulio is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med Hulio er indiceret, bør ovenstående vejledning for dosering og behandlingsvarighed følges.
English: Travel/recurrent infection
Danish: Rejser/tilbagevendende infektioner
English: Do not attempt to give your child an injection until you are sure that you understand how to do this.
Danish: Forsøg ikke at give dit barn en injektion, før du er sikker på, hvordan du skal gøre.
English: >32 weeks
Danish: >32 uger
English: The following side effects have been observed with adalimumab:
Danish: Følgende bivirkninger er observeret med adalimumab:
English: Hulio in combination with methotrexate, is indicated for:
Danish: Hulio er i kombination med methotrexat er indiceret til:
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, såsom adalimumab, påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: To help you remember which day(s) of the week Hulio should be injected, it may be helpful to make a note on a calendar or in a diary.
Danish: Som en hjælp til at huske på, hvilken/hvilke dag/dage du skal injicere Hulio, kan det være en god ide at lave en note i en kalender eller en lommebog.
English: b 2-sided P value from log rank test. c NE = not estimable.
Danish: b 2-sidet P-værdi fra log rank test. c NE = ikke estimerbar.
English: Hulio is a biosimilar medicinal product.
Danish: Hulio er et biosimilært lægemiddel.
English: Hulio is supplied as packs containing 1 or 2 boxes.
Danish: Hulio fås i pakninger med 1 eller 2 æsker.
English: • If you are over 65 years you may be more susceptible to infections while taking Hulio.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Hulio.