FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel Acino Pharma can be started between a few days and 35 days after the attack;
Danish: Acino Pharma kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Clopidogrel Acino Pharma is a ‘generic medicine'.
Danish: Clopidogrel Acino Pharma er et ‘generisk lægemiddel'.
English: Clopidogrel Acino Pharma can be started between seven days and six months after the stroke;
Danish: Behandlingen med Clopidogrel Acino Pharma kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter,
English: Because Clopidogrel Acino Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Acino Pharma er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The full EPAR for Clopidogrel Acino Pharma can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Acino Pharma findes her.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Danish: • patienter med perifer arteriesygdom (problemer med blodgennemstrømningen i arterierne).
English: Clopidogrel Acino Pharma is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Acino Pharma er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: What are the benefit and risk of Clopidogrel Acino Pharma?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Acino Pharma?
English: The Committee recommended that Clopidogrel Acino Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Acino Pharma.
English: The active substance in Clopidogrel Acino Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Acino Pharma, clopidogrel, er en trombocytfunktionshæmmer.
English: Why has Clopidogrel Acino Pharma been approved?
Danish: Hvorfor blev Clopidogrel Acino Pharma godkendt?
English: How has Clopidogrel Acino Pharma been studied?
Danish: Hvordan blev Clopidogrel Acino Pharma undersøgt?
English: What is Clopidogrel Acino Pharma?
Danish: Hvad er Clopidogrel Acino Pharma?
English: How is Clopidogrel Acino Pharma used?
Danish: Hvordan anvendes Clopidogrel Acino Pharma?
English: What is Clopidogrel Acino Pharma used for?
Danish: Hvad anvendes Clopidogrel Acino Pharma til?
English: How does Clopidogrel Acino Pharma work?
Danish: Hvordan virker Clopidogrel Acino Pharma?
English: All these signs resolve spontaneously within 24 hours.
Danish: Alle disse tegn forsvinder spontant inden for 24 timer.
English: This summary was last updated in July 2019.
Danish: Dette sammendrag blev sidst ajourført i 07-2019.
English: Contact with the applicator should be avoided.
Danish: Berøring med applikatoren bør undgås.
English: Broadline received a marketing authorisation valid throughout the EU on 4 December 2013.
Danish: Broadline fik en markedsføringstilladelse med gyldighed i hele EU den 4. december 2013.
English: The product is to be used only when all three groups of parasites are targeted at the same time.
Danish: Produktet anvendes kun, når alle tre grupper af parasitter er omfattet på samme tid.
English: Other information about Broadline
Danish: Andre oplysninger om Broadline
English: Handling of treated animals should be limited until the application site is dry and children should not play with treated animals during this period.
Danish: Håndtering af behandlede dyr bør begrænses, indtil påføringsstedet er tørt, og børn må ikke lege med behandlede dyr i denne periode.
English: Fipronil kills adult parasites.
Danish: Fipronil dræber voksne parasitter.
English: The European Medicine Agency decided that Broadline's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Broadline opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: This means that they kill parasites that live inside the body of animals.
Danish: Det betyder, at de dræber parasitter, der lever inde i dyrets krop.
English: Further information on Broadline can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/broadline.
Danish: Yderligere information om Broadline findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/broadline.
English: People applying the medicine should not smoke, eat or drink while doing so and should wash their hands after handling the product.
Danish: Personer, som påfører lægemidlet, må ikke ryge, spise eller drikke imens og skal efterfølgende vaske hænder.
English: Why is Broadline authorised in the EU?
Danish: Hvorfor er Broadline godkendt i EU?
English: An overview of Broadline and why it is authorised in the EU
Danish: En oversigt over Broadline, og hvorfor det er godkendt i EU
English: What is Broadline and what is it used for?
Danish: Hvad er Broadline, og hvad anvendes det til?
English: The content of one full applicator (appropriate to the cat's weight) is applied directly to the cat's skin after parting the hair, in a single spot on the middle of the neck.
Danish: Indholdet af en fuld applikator (svarende til kattens vægt) påføres direkte på kattens hud på et og samme sted midt på nakken, efter at pelsen er delt.
English: Consequently, it is recommended that recently treated animals do not sleep with owners, especially children.
Danish: Det frarådes derfor at lade nybehandlede dyr sove sammen med dyrets ejer, navnlig børn.
English: What are the risks associated with Broadline?
Danish: Hvilke risici er der forbundet med Broadline?
English: Broadline must not be used in sick or recovering animals.
Danish: Broadline må ikke anvendes hos dyr, der er syge eller afkræftede.
English: For lungworm a second treatment may be recommended one month after the initial treatment.
Danish: Hvad angår lungeorm, kan der anbefales endnu en behandling en måned efter den første behandling.
English: If the cat licks the application site, temporary excessive salivation may occur.
Danish: Hvis katten slikker på påføringsstedet, kan der forekomme midlertidig kraftig savlen.
English: Broadline can also be used to prevent heartworm disease for one month.
Danish: Broadline kan desuden anvendes til forebyggelse af angreb af hjerteorm i en måned.
English: Broadline (fipronil/(S)methoprene/eprinomectin/praziquantel)
Danish: Broadline (fipronil/(S)methopren/eprinomectin/praziquantel)
English: People with known hypersensitivity to any of the ingredients should avoid contact with the product.
Danish: Personer med kendt overfølsomhed (allergi) over for et eller flere af indholdsstofferne bør undgå kontakt med produktet.
English: This means that they kill external parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Danish: Det vil sige, at de dræber parasitter, der lever på dyrets hud eller i pelsen, f.eks. lopper og flåter.
English: It treats tick infestations and prevents new infestations for up to three weeks.
Danish: Det anvendes til behandling af flåtangreb og forhindrer nye angreb i op til tre uger.
English: (S)-methoprene is an insect growth regulator which stops the flea life cycle by killing eggs and blocking the development of juvenile flea stages and causing their death.
Danish: (S)-methopren regulerer insekters vækst og blokerer loppers livscyklus ved at dræbe æggene og standse loppernes udvikling i et tidligt stadium, så de dør.
English: For more information about using Broadline, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Broadline, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: For ticks, effectiveness was between 85 and 93% for Broadline-treated cats compared with 92 and 98% for cats treated with the comparator product.
Danish: For flåter var Broadlines effektivitet 85-93 % mod 92-98 % for katte behandlet med sammenlignings-produktet.
English: Broadline was 100% effective against the L4 larval stage of heartworm.
Danish: Broadlines effektivitet var 100 % mod hjerteorm på L4-larvestadiet.
English: The study showed effectiveness of 86 to 87% against adult fleas for Broadline throughout the 30 day post-treatment period compared with between 76 and 82% for cats treated with another medicine containing just fipronil and (S)-methoprene.
Danish: I studiet var Broadlines effektivitet 86-87 % over for voksne lopper i hele 30-dages perioden efter behandlingen mod 76-82 % for katte, der kun var blevet behandlet med et andet lægemiddel, der kun indeholdt fipronil og (S)-methopren.
English: Broadline-treated cats were compared to cats treated with a spot-on product containing the worm medicines emodepside and praziquantel.
Danish: Katte behandlet med Broadline blev sammenlignet med katte behandlet med et spot-on produkt, der indeholdt ormemidlerne emodepsid og praziquantel.
English: If a cat swallows the medicine, it may result in vomiting (being sick) and/or short-lived effects on the nervous system, shown by signs such as lack of muscular coordination, disorientation, lack of interest in surroundings and pupil dilation.
Danish: Hvis katten synker lægemidlet, kan det medføre opkastning og/eller kortvarig påvirkning af nervesystemet, der viser sig ved manglende koordination af muskler, desorientering, manglende interesse for omgivelserne og udvidede pupiller.
English: It may also be used as part of a treatment strategy for flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Det kan desuden anvendes som led i en behandlingsstrategi anvendt ved overfølsomhed for loppebid (en allergisk reaktion på loppebid).
English: Broadline was more than 90% effective in reducing lungworm larvae at 28 days after treatment and all treated cats showing respiratory signs (such as wheezing, persistent coughing and a runny nose) were clinically cured.
Danish: Broadline var mere end 90 % effektivt til at nedbringe antallet af lungeormslarver 28 dage efter behandlingen, og alle de behandlede katte, som havde luftvejssymptomer (såsom hvæsende vejrtrækning, vedholdende hoste og løbende snude) blev klinisk raske.
English: Twenty cats naturally infested with lungworm were treated with Broadline.
Danish: 20 katte med naturlige lungeormsangreb blev behandlet med Broadline.
English: Broadline is a veterinary medicine used to treat cats with, or at risk of, mixed infestations by tapeworms, roundworms and external parasites (fleas, ticks, and a burrowing mite called Notoedres cati which is a cause of mange).
Danish: Broadline er et veterinærlægemiddel, der anvendes til behandling af katte, der er eller risikerer at blive udsat for blandede angreb af bændelorm, rundorm og ydre parasitter (lopper, flåter og miden Notoedres cati, som er årsag til skab).
English: If eye irritation persists, or if side effects are noticed, medical advice should be sought and the package leaflet or label shown to the doctor.
Danish: Ved vedvarende øjenirritation eller bivirkninger søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: The study showed over 98% effectiveness of the medicine against the mite, with a clinical cure in all animals.
Danish: i studiet blev det påvist, at lægemidlets effektivitet var 98 % mod mideangreb, og alle dyrene blev klinisk raske.
English: Effectiveness was measured by identifying adult worm segments (tapeworms) or counting worm eggs (roundworms) in faeces at day 14 after treatment.
Danish: Virkningen blev målt ved påvisning af voksne ormesegmenter (bændelorm) eller optælling af ormeæg (rundorm) i dyrenes afføring på dag 14 efter behandlingen.
English: The measure of effectiveness was reduction of the number of Notoedres cati mites found in skin scrapings compared to cats that received no treatment.
Danish: Virkningen blev bedømt på nedgangen i antallet af Notoedres cati-mider, der blev fundet i hudskrabninger, sammenlignet med ubehandlede katte.
English: How is Broadline used?
Danish: Hvordan anvendes Broadline?
English: It must not be used in rabbits or in cases of hypersensitivity (allergy) to any of the ingredients.
Danish: Det må ikke anvendes hos kaniner eller dyr, der er overfølsomme (allergiske) over for et eller flere af indholdsstofferne.
English: The effectiveness of Broadline against cat mange was examined in a laboratory study with 18 naturally infested cats.
Danish: Virkningen af Broadline mod skab hos katte blev undersøgt i et laboratoriestudie med 18 naturligt angrebne katte.
English: The effectiveness of Broadline to prevent heartworm disease was shown in three laboratory studies, using artificially infected cats.
Danish: Virkningen af Broadline til forebyggelse af hjerteorm blev påvist i tre laboratoriestudier med katte, der var kunstigt inficeret.
English: What benefits of Broadline have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Broadline?
English: It blocks channels in their nerve cells that allow charged chloride particles (ions) to pass, interfering with the transmission of nerve signals and leading to overstimulation and death.
Danish: Det blokerer de kanaler i nervecellerne, der transporterer ladede klorpartikler (kloridioner) og griber derved ind i nervernes signaloverførsel, hvilket medfører overstimulation og død.
English: How does Broadline work?
Danish: Hvordan virker Broadline?
English: The effectiveness of Broadline against fleas and ticks was investigated in an EU field study involving cats infested with fleas, ticks, or both.
Danish: Virkningen af Broadline mod lopper og flåter blev undersøgt i et EU-feltstudie med katte, som var angrebet af lopper, flåter eller begge dele.
English: The other two active substances in Broadline, eprinomectin and praziquantel, act as ‘endoparasiticides'.
Danish: De to aktive stoffer i Broadline, eprinomectin og praziquantel, virker som "endoparasiticider".
English: For external parasites, Broadline treats flea infestations and prevents new infestations for at least one month; it also prevents environmental flea contamination for over a month.
Danish: Hvad angår ydre parasitter, behandler Broadline loppeangreb og forhindrer nye angreb i mindst én måned.
English: Broadline contains four active substances: fipronil, (S)-methoprene, eprinomectin and praziquantel.
Danish: Broadline indeholder fire aktive stoffer, nemlig fipronil, (S)-methopren, eprinomectin og praziquantel.
English: The effectiveness of Broadline against feline lungworm was investigated in a field study in Italy.
Danish: Virkningen af Broadline mod lungeorm hos katte blev undersøgt i et feltstudie i Italien.
English: Eprinomectin interferes with channels in the nerve and muscle cells of roundworms that allow charged chloride particles (ions) to pass, leading to their paralysis and death.
Danish: Eprinomectin blokerer kanalerne i rundormenes nerve- og muskelceller, som gør det muligt for ladede klorpartikler at passere (kloridioner), hvilket medfører, at de lammes og dør.
English: The main measure of effectiveness was reduction of numbers of worm larvae in faeces at 28 days after single treatment.
Danish: Virkningen blev hovedsagelig målt på nedgangen i antallet af ormelarver i afføringen 28 dage efter enkeltbehandling.
English: Two of the active substances in Broadline, fipronil and (S)-methoprene, act as ‘ectoparasiticides'.
Danish: To af de aktive stoffer i Broadline, fipronil og (S)-methopren, virker som "ektoparasiticider".
English: Broadline is available as a spot-on solution in applicators of two different volume sizes for use in cats of various bodyweights and can only be obtained with a prescription.
Danish: Det leveres som en spot-on opløsning i applikatorer i to forskellige volumenstørrelser til katte med forskellig kropsvægt.
English: For worms, Broadline is used to treat tapeworms, roundworms and hookworms in the gut as well as a type of worm that infects the bladder and two types of feline lungworm.
Danish: Hvad angår orm, anvendes Broadline mod bændelorm, rundorm og hageorme i tarmene foruden en type orm, der angriber blæren, samt to typer lungeorm hos katte.
English: Mild and short-lived skin reactions (itching, hair loss) may occur at the application site.
Danish: På påføringsstedet kan der komme lette, kortvarige hudreaktioner (kløe, hårtab).
English: Praziquantel acts on the cell membranes of tapeworms, leading to the death of the parasite.
Danish: Praziquantel virker på bændelorms cellemembraner, så parasitten lammes og dør.
English: The effectiveness of Broadline against intestinal worms was investigated in one EU field study involving cats with tapeworm, roundworm or hookworm infections or mixed infections.
Danish: Virkningen af Broadline mod indvoldsorme blev undersøgt i et EU-feltstudie af katte med rundorm, bændelorm eller hageorm eller begge dele.
English: The study showed almost 100% effectiveness against tapeworms, roundworms and hookworms for both Broadline and the comparator product.
Danish: I EU-ormestudiet var både Broadlines og sammenligningsproduktets effektivitet næsten 100 % mod bændelorm og rundorm.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docefrez to Sun Pharmaceutical Industries Europe B.V. on 15 May 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docefrez til Sun Pharmaceutical Industries Europe B.V, den 15. maj 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Docefrez.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docefrez.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docefrez.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Docefrez.
English: Docefrez can be used on its own after other treatments have failed.
Danish: Docefrez kan anvendes alene, når andre behandlinger har været virkningsløse.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet kan ligeledes findes på EMA's hjemmeside.
English: Other information about Docefrez:
Danish: Andre oplysninger om Docefrez:
English: No additional studies in patients were needed as Docefrez is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Danish: Der var ikke behov for yderligere undersøgelser af patienter, da Docefrez gives som infusion og indeholder det samme aktive stof som referencelægemidlet Taxotere.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Danish: • Prostatakræft, når kræften ikke reagerer på hormonbehandling.
English: Docefrez is given as a one-hour infusion every three weeks.
Danish: Docefrez gives hver tredje uge ved en infusion, der varer en time.
English: The full EPAR for Docefrez can be found here.
Danish: Den fuldstændige EPAR for Docefrez findes her.
English: Docefrez is used to treat the following types of cancer:
Danish: Docefrez anvendes til behandling af følgende kræftformer:
English: The Committee recommended that Docefrez be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Docefrez.
English: The active substance in Docefrez, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docefrez, docetaxel, tilhører gruppen af lægemidler mod kræft kendt som taxaner.
English: Because Docefrez is a generic medicine, the company provided data on docetaxel from the published literature.
Danish: Da Docefrez er et generisk lægemiddel, har virksomheden fremlagt data om docetaxel fra den publicerede litteratur.
English: Docefrez is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Danish: Docefrez må kun bruges, når neutrofiltallet (en type hvide blodlegemer) er mindst 1 500 celler/mm3.
English: Docefrez is a ‘generic medicine'.
Danish: Docefrez er et generisk lægemiddel.
English: This means that Docefrez is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Danish: Det betyder, at Docefrez ligner et referencelægemiddel ved navn Taxotere, som allerede er godkendt i EU.
English: Because Docefrez is a generic medicine, its benefit and risk are taken as being the same as the
Danish: Eftersom Docefrez er et generisk lægemiddel, anses dets fordele og risici for at være de samme som referencelægemidlets.
English: What are the benefit and risk of Docefrez?
Danish: Hvilken fordel/risiko er der forbundet med Docefrez?
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Taxotere.
English: Docefrez is used with cisplatin and 5-fluorouracil.
Danish: Docefrez anvendes i kombination med cisplatin og 5-fluorouracil.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Det kan også anvendes i kombination med andre lægemidler til behandling af kræft (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) hos patienter, som ikke tidligere er blevet behandlet for deres kræftsygdom, eller når andre behandlingsformer har været virkningsløse, afhængigt af hvilken type og fase brystkræft der behandles.
English: The CHMP concluded that, in accordance with EU requirements, Docefrez has been shown to be comparable to Taxotere.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Docefrez' kvalitet, sikkerhed og virkning svarer til Taxoteres.
English: Docefrez should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Docefrez bør kun anvendes på afdelinger, der er specialiseret i kemoterapi (med lægemidler mod kræft), og under overvågning af en læge, der er specialiseret i brug af kemoterapi.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Danish: • Gastrisk adenocarcinom (en form form mavekræft) hos patienter, som ikke tidligere er blevet behandlet for deres kræftsygdom.
English: Docefrez is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Docefrez anvendes i kombination med prednison eller prednisolon (antiinflammatoriske lægemidler).
English: Why has Docefrez been approved?
Danish: Hvorfor blev Docefrez godkendt?
English: For more information about treatment with Docefrez, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Docefrez fremgår af indlægssedlen (også en del af EPAR).
English: Docefrez is a powder and solvent that is made up to a solution for infusion (drip into a vein).
Danish: Docefrez er et pulver og en solvens, der anvendes til at fremstille en infusionsvæske, opløsning (intravenøst drop).
English: • head and neck cancer in patients whose cancer is advanced (has started to spread).
Danish: • Hoved- og halskræft hos patienter med fremskreden kræft (dvs. som er begyndt at metastasere).
English: For full details, see the Summary of Product Characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (der ligeledes er en del af denne EPAR).
English: Docefrez is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Danish: Docefrez anvendes i kombination med cisplatin og 5fluorouracil (andre lægemidler mod kræft).