FrancophonIA/ELRC3.0 huggingface dataset:
English: After opening place the container back into the pouch, in case a second dose is necessary.
Danish: Når beholderen er åbnet, lægges den tilbage i posen, hvis endnu en dosis skulle blive nødvendig.
English: EXPIRY DATE EXP {month/year} Once opened use within 30 minutes.
Danish: Efter åbning skal produktet anvendes inden for 30 minutter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske
English: INDICATION(S) For induction of vomiting in dogs.
Danish: INDIKATIONER Til induktion af opkastning hos hunde.
English: Your dog must not be given this medicine if it: - has decreased consciousness, seizures or other similar neurologic symptoms or difficulties in breathing or swallowing that could make the dog inhale a part of the vomit potentially causing aspiration pneumonia - has ingested sharp foreign objects, acids or alkalis (e.g. drain or toilet bowl cleaners, household detergents, battery fluids), volatile substances (e.g. petroleum products, essential oils, air fresheners) or organic solvents (e.g. antifreeze, windshield wiper fluids, nail polish remover) - is hypersensitive to ropinirole or to any of the excipients.
Danish: - har indtaget skarpe fremmedlegemer, syrer eller baser (f.eks. afløbs- eller toiletrensemidler, husholdningsvaskemidler, batterivæsker), flygtige stoffer (f.eks. olieprodukter, essentielle olier, luftfriskere) eller organiske opløsningsmidler (f.eks. antifrostvæsker, sprinklervæske, neglelakfjerner).
English: Uncommon adverse reactions: Corneal ulceration.
Danish: Ikke almindelige reaktioner: sårdannelse på hornhinden.
English: ADMINISTRATION:
Danish: INDGIVELSE:
English: PHARMACEUTICAL FORM Eye drops solution in single-dose container.
Danish: LÆGEMIDDELFORM Øjendråber, opløsning i enkeltdosisbeholder.
English: If the dog does not vomit within 15 minutes after administration of the initial dose, a second dose may be given 15 to 20 minutes after administration of the initial dose.
Danish: Hvis hunden ikke kaster op inden for 15 minutter efter indgivelse af den indledende dosis, kan der gives en anden dosis 15 til 20 minutter efter indgivelse af den første dosis.
English: Please refer to sections 4.9 and 5.1 for further information.
Danish: 4.9 og 5.1.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops ropinirole
Danish: VETERINÆRLÆGEMIDLETS NAVN Clevor 30 mg/ml øjendråber ropinirol
English: The time to last vomit ranged from 30 to 82 minutes following ocular administration in a pharmacokinetic study in dogs.
Danish: I et farmakokinetikstudie i hunde varierede tiden til sidste opkast fra 30 til 82 minutter efter okulær indgivelse.
English: (µg/kg)
Danish: Ropinirol (µg/kg)
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
English: In case the dog does not vomit within 15 minutes after the initial administration, a second dose can be given 15 to 20 minutes after administration of the initial dose.
Danish: Dersom hunden ikke kaster op inden for 15 minutter efter den første indgivelse, kan der gives endnu en dosis 15 til 20 minutter efter indgivelse af den første dosis.
English: The safety of the product has not been studied in dogs with hepatic impairment.
Danish: Produktets sikkerhed er ikke blevet undersøgt hos hunde med nedsat leverfunktion.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol)
Danish: VETERINÆRLÆGEMIDLETS NAVN Clevor 30 mg/ml øjendråber, opløsning i enkeltdosisbeholder til hunde ropinirol (ropinirole)
English: PACKAGE LEAFLET: Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Danish: INDLÆGSSEDDEL: Clevor 30 mg/ml øjendråber, opløsning i enkeltdosisbeholder til hunde
English: Very common adverse reactions: Transient mild or moderate hyperaemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm.
Danish: Kortvarig, mild eller moderat hyperæmi i øjet, udflåd fra øjnene, fremfald af tredje øjenlåg og blefarospasme.
English: Instructions for administration
Danish: Brugsanvisning
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Clevor 30 mg/ml øjendråber, opløsning i enkeltdosisbeholder til hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution for dogs ropinirole
Danish: VETERINÆRLÆGEMIDLETS NAVN Clevor 30 mg/ml øjendråber, opløsning til hunde ropinirol
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Bortskaffelse: Læs indlægssedlen.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: Ropinirole
Danish: Natriumchlorid
English: Human albumin.
Danish: Humant albumin.
English: 72 hours.
Danish: 72 timer.
English: • These shall contain the following key elements:
Danish: • Disse skal indeholde følgende vigtige elementer:
English: No case of overdose has been reported.
Danish: Ingen tilfælde af overdosering er blevet indberettet.
English: Date of first authorisation: 23 March 2018
Danish: Dato for første markedsføringstilladelse: 23. marts 2018
English: This medicine contains cells of human origin.
Danish: Dette lægemiddel indeholder celler af human oprindelse.
English: Common side effects (may affect up to 1 to 10 patients):
Danish: Almindelige bivirkninger (kan påvirke op til 1 af 10 patienter):
English: In addition a long term follow-up was conducted up to Week 52.
Danish: Endvidere blev der foretaget langvarig opfølgning op til uge 52.
English: No in vivo interaction studies have been performed.
Danish: Der er ikke udført in vivo interaktionsstudier.
English: • The educational material for health professionals should contain:
Danish: • Undervisningsmaterialet for sundhedsprofessionelle skal inkludere:
English: Do not give this medicine to children and adolescents (i.e. aged under 18 years) because the potential benefits and risks are unknown.
Danish: Dette lægemiddel må ikke gives til børn og unge (under 18 år), da de mulige fordele og risici er ukendte.
English: EXP {XX-XXX-XXXX at XX:XX CET}
Danish: EXP {XX-XXX-XXXX kl. XX:XX CET}
English: Patients should be followed up for potential signs of infection after administration.
Danish: Patienter skal følges op for eventuelle tegn på infektion efter administration.
English: Procedural pain*
Danish: Procedurerelaterede smerter*
English: In general, these side effects are quite mild and disappear in the days following the fistula procedure.
Danish: Generelt er disse bivirkninger ret lette og forsvinder i dagene efter udrensningen.
English: As this medicine will be used during surgery, the hospital staff is responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Danish: Da dette lægemiddel vil blive anvendt under operation, er hospitalspersonalet ansvarlige for korrekt opbevaring af lægemidlet før og under anvendelsen såvel som for korrekt bortskaffelse.
English: eASC were not present in any of the tissues analysed after 3 months or 6 months.
Danish: eASC fandtes ikke i noget af det analyserede væv efter 3 måneder eller 6 måneder.
English: There are no data from the use of darvadstrocel in pregnant women.
Danish: Der er ingen data fra anvendelse af darvadstrocel til gravide kvinder.
English: 6 mL 30 million cells
Danish: 6 ml 30 millioner celler
English: Lack of de novo DSA generation was observed between Week 12 and Week 52.
Danish: Manglende de novo DSA-generation blev set mellem uge 12 og uge 52.
English: Because the final check takes place just before Alofisel is sent to the hospital, the results of this last check are not known when it is given to you.
Danish: Da den endelige kontrol finder sted lige inden Alofisel bliver sendt til hospitalet, kendes resultaterne af denne sidste kontrol ikke, når du får produktet.
English: The efficacy of Alofisel was assessed in the ADMIRE-CD study.
Danish: Effekten af Alofisel blev vurderet i ADMIRE-CD-studiet.
English: This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine.
Danish: Dette bør overvejes, hvis du er allergisk over for disse antibiotika, da disse antibiotika er tilsat under lægemidlets fremstillingsproces.
English: No association between DSA results and safety or efficacy up to Week 52 was seen in the subset tested.
Danish: Der er ikke set en sammenhæng mellem DSA resultater og sikkerhed eller effekt i op til 52 uger i de testede undergrupper.
English: The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppigheden af forekomst af bivirkninger er defineret i henhold til den følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • inject Alofisel.
Danish: • Injicere Alofisel.
English: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain
Danish: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spanien
English: This should be considered in patients with known hypersensitivity to these classes of antibiotics.
Danish: Dette bør overvejes hos patienter med kendt overfølsomhed over for disse antibiotikaklasser.
English: Do not store above 25 °C or below 15 °C.
Danish: Må ikke opbevares ved temperaturer over 25 °C eller under 15 °C.
English: A total of 212 patients were randomised, and 205 patients received a local injection of either Alofisel 120 million cells or placebo in a 1:1 design.
Danish: I alt blev 212 patienter randomiseret og 205 patienter modtog en lokal injektion af enten Alofisel 120 millioner stamceller eller placebo i et 1:1 design.
English: Therefore, no dose adjustment is required in elderly patients.
Danish: Det er derfor ikke nødvendigt at justere dosis til ældre patienter.
English: Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature.
Danish: Opbevar altid produktet i den ydre karton og i forsendelseskassen helt indtil administration for at holde den påkrævede temperatur.
English: In line with standards for the management of complex perianal fistulas, characterisation of the patient's fistulas is needed prior to treatment.
Danish: I overensstemmelse med standarderne for behandling af komplekse perianale fistler er en karakterisering af patientens fistler nødvendigt inden behandling.
English: Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Danish: Samtidig brug af stabile doser af immunsuppressiva (18 % af patienter) eller anti-TNF'er (33 %) eller begge dele (28 %) var tilladt under studiet.
English: The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential.
Danish: Effekten af ex vivo ekspansion på stamcellernes genetiske stabilitet er blevet vurderet in vitro uden indikation af karcinogent potentiale.
English: Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}.
Danish: Farmakoterapeutisk klassifikation: {endnu ikke tildelt}, ATC-kode: {endnu ikke tildelt}.
English: You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration.
Danish: Du kan have haft en konsultation med kirugen 2-3 uger før indgivelse af Alofisel.
English: The aim of the educational programme is to provide information on how to correctly administer the product in order to minimise the risk of medication errors and to increase awareness about the potential transmission of infectious agents.
Danish: Formålet med uddannelsesprogrammet er at give information om, hvordan produktet administreres korrekt for at minimere risikoen for medicineringsfejl og øge opmærksomheden omkring potentiel risiko for overførsel af potentielt inficeret materiale.
English: The full content of the 4 vials must be administered for the treatment of up to two internal openings and up to three external openings.
Danish: Alt indholdet af de 4 hætteglas skal administreres til behandlingen af op til to interne åbninger og op til tre eksterne åbninger.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/surgeon for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal det vurderes af din læge/kirurg før du får dette lægemiddel.
English: In the unlikely event that the results detected an infection, your treatment team will be informed who will tell you if you need any laboratory tests of treatment for the infection.
Danish: I det usandsynlige tilfælde, at resultaterne påviser en infektion af stamcellerne, vil dit behandlingsteam blive underrettet, og de vil fortælle dig, om du skal have taget nogle laboratorieundersøgelser eller have behandling for en evt. infektion.
English: • Guide for health professionals providing information on potential for microbial information and advice on steps to follow in case a positive culture is identified.
Danish: • Vejledning til sundhedsprofessionelle, som giver information om potentiel mikrobiel kontaminering samt råd om de trin, som skal følges, hvis der identificeres en positiv kultur ved dyrkning.
English: Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Danish: Patienter havde sivende komplekse perianale fistler med utilstrækkeligt respons på mindst en af følgende behandlinger: Antibiotika, immunsuppressiva eller anti-TNF'er.
English: The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established.
Danish: Pædiatrisk population Sikkerhed og virkning af darvadstrocel hos børn og unge i alderen 0-17 år er endnu ikke klarlagt.
English: After perianal and intrarectal injection of human eASC in athymic rats, cells were present in the rectum and jejunum at the site of injection for at least 14 days and were undetectable after 3 months.
Danish: Efter perianal og intrarektal injektion af human eASC i athymiske rotter, fandtes der stamceller i rectum og jejunum ved injektionsstedet i minimum 14 dage, men de var ikke detekterbare efter 3 måneder.
English: Some side effects of Alofisel treatment are related to the process of cleaning your fistulas.
Danish: Nogle af bivirkningerne ved behandling med Alofisel er relateret til processen, der består i rensning af dine fistler.
English: b) Identify the location of the internal openings.
Danish: b)Kortlæg placering af de interne åbninger.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP.
English: Alofisel is supplied on an individual patient basis.
Danish: Alofisel leveres til patienter på individuel basis.
English: Softly massage the area around the external openings for 20-30 seconds and cover the external openings with a sterile bandage.
Danish: Massér forsigtigt området omkring de eksterne åbninger i 20-30 sekunder og dæk de eksterne åbninger med en steril forbinding.
English: * Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments
Danish: * Inklusiv drænage af abscesser, anlæggelse/fjernelse af Seton-tråde, udskrabning, sammensyning af interne åbninger og medicinsk behandling
English: Perianal fistulas can cause pain, irritation and discharge of pus through the openings to the skin.
Danish: Perianale fistler kan forårsage smerter, irritation og udflåd af pus gennem åbningerne i huden.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Preserve the container away from heat and direct light sources and do not refrigerate or freeze.
Danish: Forsendelseskassen skal holdes væk fra varme og direkte lyskilder og må ikke opbevares i køleskab eller nedfryses.
English: Also contains: Dulbecco's Modified Eagle´s Medium (DMEM) and Human albumin.
Danish: Indeholder også: Dulbecco's Modified Eagle´s Medium (DMEM) og humant albumin.
English: The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Danish: Den følgende liste over bivirkninger er baseret på erfaring fra kliniske forsøg og vises efter systemorganklasse.
English: If after the procedure you feel ill or have fever, please inform your physician as soon as you can.
Danish: Hvis du føler dig syg eller får feber efter indgrebet, skal du underrette din læge, så snart du kan.
English: • Guide for surgeons and other health professionals describing the method of administration
Danish: • Skriftlig vejledning for kirurger og andre sundhedsprofessionelle, som beskriver administrationsmetoden.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: In the ADMIRE-CD study, 63/103 of the eASC-treated patient population were analysed for the presence of donor-specific antibodies (DSA) at baseline and Week 12.
Danish: I ADMIRE-CD-studiet blev 63/103 af den eASC-behandlede patientpopulation analyseret for tilstedeværelse af donor-specifikke anti-stoffer (DSA) baseline og uge 12.
English: Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated.
Danish: Alofisel må kun administreres af speciallæger erfarne i diagnosticering og behandling af sygdomme, for hvilke Alofisel er indiceret.
English: Alofisel group (Alofisel+standard of care*) N= 103
Danish: Alofisel-gruppe (Alofisel+standardbehandling*) N = 103
English: Women of childbearing age should use effective contraception during treatment with Alofisel.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandling med Alofisel.
English: Control group (Placebo+standard of care*) N= 102
Danish: Kontrolgruppe (Placebo+standardbehandling*) N = 102
English: There were no patients in Alofisel group with events of proctalgia of severe intensity and 3.9% patients with 4 events in the control group.
Danish: Der var ingen patienter i Alofisel-gruppen med proktalgi-hændelser af alvorlig intensitet, og 3,9 % af patienter med 4 hændelser i kontrolgruppen.
English: • Guide in form of a video for surgeons and other health professionals involved in the preparation and administration of Alofisel.
Danish: • Vejledning i form af en video til kirurger og andre sundhedsprofessionelle involveret i forberedelse og administration af Alofisel.
English: Of patients with DSA at Week 12, 7/23 (30%) had cleared DSA by Week 52.
Danish: Af patienter med DSA ved uge 12 havde 7/23 (30 %) elimineret DSA ved uge 52.
English: This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area.
Danish: Dette betyder, at det med en behandling med en dosis på i alt 120 millioner stamceller er muligt at behandle op til tre fistelkanaler, som munder ud i det perianale område.
English: e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Danish: e) Gentag trin (b), (c) og (d) for hvert hætteglas i rækken efter at stamcellerne fra det tidligere hætteglas er indgivet.
English: • Relevant information on the risk of medication errors and the potential for transmission of infectious agents and details on how to minimise these, including reception, storage and administration instructions (i.e. fistula conditioning, preparation and injection).
Danish: • Relevant information om risikoen for medicineringsfejl og muligheden for overførsel af smitsomme stoffer samt oplysninger om, hvordan denne risiko minimeres ved modtagelse, opbevaring og instruktioner i administration (dvs. forbehandling af fistel, forberedelse til injektion samt injektion i fistler).
English: Immediately prior to the administration of Alofisel, the fistula tracts should be conditioned as follows: a) If setons are in place, they must be removed.
Danish: Umiddelbart inden administration af Alofisel, skal fistelkanalerne forbehandles på følgende måde: a) Hvis, der er anlagt Seton-tråde, skal disse fjernes.
English: Adverse reactions System Organ Class
Danish: Bivirkninger Systemorganklasse
English: The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Danish: Produkttypen og den tilsigtede kliniske brug af darvadstrocel gør, at konventionelle undersøgelser af farmakokinetik (absorption, fordeling, metabolisme og elimination) ikke er relevante.
English: What you need to know before you are given Alofisel 3.
Danish: Det skal du vide, før du får Alofisel 3.
English: What Alofisel contains
Danish: Alofisel indeholder
English: The key secondary endpoints were defined as clinical remission (clinical closure of all treated fistula) and response (clinical closure of at least 50% of all treated fistulas) at Week 24.
Danish: De vigtigste sekundære effektmål var defineret som klinisk remission (klinisk lukning af alle behandlede fistler) og respons (klinisk lukning af mindst 50 % af alle behandlede fistler) ved uge 24.
English: Do not irradiate or otherwise sterilise.
Danish: Må ikke bestråles eller steriliseres på anden vis.
English: Store between 15 ºC and 25 ºC.
Danish: Opbevares ved temperaturer mellem 15 ºC og 25 ºC.
English: Prior to the launch of Alofisel in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Alofisel i hver medlemstat, skal indehaveren af markedsføringstilladelsen (MAH) og de nationale tilsynsmyndigheder være enige om indholdet og formatet af uddannelsessprogrammet, herunder kommunikationsmediet, nødvendighed for distribution og alle øvrige aspekter.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel sundhedsrisiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser.