FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Osigraft (seen in between 1 and 10 patients in 100) are erythema (redness), tenderness, swelling over the implant site, heterotopic ossification (development of bone in abnormal areas) or myositis ossificans (abnormal bone growth in the muscle), and the formation of antibodies against eptotermin alfa.
Danish: De hyppigste bivirkninger ved Osigraft (som optræder hos mellem 1 og 10 ud af 100 patienter) er erytem (rødmen), ømhed, hævelse på implantatstedet, heterotopisk ossifikation (knogledannelse i abnorme områder) eller myositis ossificans (abnorm knoglevækst i musklen) og dannelse af antistoffer mod eptotermin alfa.
English: Osigraft is a powder to be made up into a suspension for implantation.
Danish: Osigraft er et pulver, der blandes til en suspension til implantation.
English: It is a copy of a protein called osteogenic protein 1, also known as bone morphogenetic protein 7 (BMP-7), that is produced naturally by the body and which helps the formation of new bone tissue.
Danish: Det er en kopi af et protein kaldet osteogent protein 1, også kendt som knoglemorfogenetisk protein 7 (BMP-7), der produceres naturligt i kroppen og fremmer dannelsen af nyt knoglevæv.
English: The main study of Osigraft was carried out in 122 patients with unhealed tibial fractures who were treated either with the medicine or with an autograft.
Danish: Der blev gennemført en hovedundersøgelse med Osigraft hos 122 patienter med uhelede skinnebensbrud, som blev behandlet med enten Osigraft eller et autotransplantat.
English: Immediately before use, Osigraft is mixed with 2 to 3 ml of sodium chloride solution to make up a suspension that has the consistency of wet sand.
Danish: Osigraft blandes umiddelbart inden brug med 2-3 ml natriumchloridopløsning til en suspension med konsistens som vådt sand.
English: The main measure of effectiveness, which was assessed after nine months, was whether the broken bone had healed.
Danish: Virkningen, der blev vurderet efter ni måneder, blev hovedsagelig bedømt på, hvorvidt den brækkede knogle var helet.
English: • where the fracture is disease-related (such as metabolic bone disease or cancer);
Danish: • patienter, hvis brud er sygdomsrelateret (f.eks. metabolisk knoglesygdom eller kræft)
English: It is used in patients who have previously had an autograft (a bone graft taken from their own bone, usually the hip) that has failed or when such a graft is not possible.
Danish: Det anvendes hos patienter, som tidligere har fået et autotransplantat (et knogletransplantat taget fra patienternes egne knogler, sædvanligvis fra hoften), der ikke fungerede, eller hos hvem en sådan transplantation ikke er mulig.
English: It contains the active substance eptotermin alfa.
Danish: Det indeholder det aktive stof eptotermin alfa.
English: This was detected by looking at signs of repair of the fracture on an X-ray, whether the patient had any pain and was able to bear weight on the tibia, and whether there was any need for further treatment of the fractured tibia.
Danish: Dette blev målt ved at se på tegnene på sammenvoksning af bruddet på et røntgenbillede; på, hvorvidt patienten havde smerter og var i stand til at belaste skinnebenet; og på, hvorvidt der var behov for yderligere behandling af det brækkede skinneben.
English: When implanted, eptotermin alfa stimulates the formation of new bone, helping to repair the broken bone.
Danish: Når det implanteres, stimulerer eptotermin alfa dannelsen af nyt knoglevæv og er med til at reparere den brækkede knogle.
English: What is the risk associated with Osigraft?
Danish: Hvilken risiko er der forbundet med Osigraft?
English: It is used in skeletally mature patients (who have stopped growing).
Danish: Det bruges hos patienter med fuldt udvokset skelet (som ikke længere vokser).
English: • without enough skin or blood supply at the fracture site;
Danish: • patienter med utilstrækkelig huddækning eller blodtilførsel på brudstedet
English: The replacement eptotermin alfa acts in same way as naturally produced BMP-7.
Danish: Det supplerende eptotermin alfa fungerer på samme måde som BMP-7, der produceres naturligt i kroppen.
English: This mixture is then placed by the surgeon directly at the fracture site in contact with the prepared broken bone ends.
Danish: Kirurgen påfører herefter blandingen direkte på brudstedet på de klargjorte ender af den brækkede knogle.
English: Why has Osigraft been approved?
Danish: Hvorfor blev Osigraft godkendt?
English: The active substance in Osigraft, eptotermin alfa, acts on the bone structure.
Danish: Det aktive stof i Osigraft, eptotermin alfa, indvirker på knoglestrukturen.
English: • with a tumour near the fracture;
Danish: • patienter, som har en tumor i nærheden af bruddet
English: For the full list of all side effects reported with Osigraft, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Osigraft fremgår af indlægssedlen.
English: What is Osigraft?
Danish: Hvad er Osigraft?
English: Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce it.
Danish: Det dannes af celler, som har fået indsat et gen (dna), der sætter dem i stand til at producere det.
English: What is Osigraft used for?
Danish: Hvad anvendes Osigraft til?
English: How has Osigraft been studied?
Danish: Hvordan blev Osigraft undersøgt?
English: What benefit has Osigraft shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Osigraft?
English: • skeletally immature (still growing);
Danish: • patienter, hvis skelet endnu ikke er fuldt udvokset (som stadig vokser)
English: How is Osigraft used?
Danish: Hvordan anvendes Osigraft?
English: How does Osigraft work?
Danish: Hvordan virker Osigraft?
English: Where necessary, treatment can be repeated every twelve weeks.
Danish: Om nødvendigt kan behandlingen gentages hver 12. uge.
English: Bravecto Plus received a marketing authorisation valid throughout the EU on 8 May 2018.
Danish: Bravecto Plus fik en markedsføringstilladelse med gyldighed i hele EU den 8. maj 2018.
English: Further information on Bravecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
Danish: Yderligere oplysninger om Bravecto Plus findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
English: The medicine should be kept in the original package until use, in order to prevent children directly accessing the medicine.
Danish: Lægemidlet bør opbevares i den originale pakning indtil brug for at undgå, at børn får direkte adgang til lægemidlet.
English: Bravecto Plus kills fleas and ticks within 48 hours.
Danish: Bravecto Plus dræber lopper og flåter i løbet af 48 timer.
English: This medicine is harmful if swallowed.
Danish: Dette lægemiddel er skadeligt, hvis det indtages.
English: The pipette to use is selected on the basis of the cat's weight.
Danish: Den pipette, der skal anvendes, vælges ud fra kattens vægt.
English: The European Medicines Agency decided that Bravecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Bravecto Plus opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Fluralaner acts as an ‘ectoparasiticide'.
Danish: Fluralaner virker som et "ektoparasiticid".
English: Other information about Bravecto Plus
Danish: Andre oplysninger om Bravecto Plus
English: The most common side effects with Bravecto Plus (which may affect up to 1 in 10 animals) are mild and short-lived reactions at the application site such as hair loss, flaking skin and scratching.
Danish: De hyppigste bivirkninger ved Bravecto Plus (som kan optræde hos op til 1 ud af 10 dyr) er lette, kortvarige reaktioner på påføringsstedet, såsom hårtab, skællende hud og kløe.
English: Bravecto Plus is effective at preventing heartworm disease for 8 weeks.
Danish: Bravecto Plus forebygger effektivt hjerteormsygdom i 8 uger.
English: For ear mite infestations, a veterinary check is necessary 28 days after treatment.
Danish: Ved øremideangreb skal dyrlægen foretage en kontrol 28 dage efter behandlingen.
English: The spot-on solution is available in different strengths for cats of different weights.
Danish: Spot-on opløsningen fås i forskellige styrker til katte med forskellig vægt.
English: An overview of Bravecto Plus and why it is authorised in the EU
Danish: En oversigt over Bravecto Plus og hvorfor det er godkendt i EU
English: Fluralaner kills fleas and ticks that have ingested the cat's blood by causing uncontrolled activity of their nervous system.
Danish: Fluralaner dræber lopper og flåter, der har indtaget kattens blod, ved at forårsage ukontrolleret aktivitet i deres nervesystem.
English: The medicine's actions against fleas and ticks last for 12 weeks after being applied.
Danish: Lægemidlets virkning mod lopper og flåter varer i 12 uger efter påføringen.
English: Bravecto Plus was as effective as another medicine containing emodepside and praziquantel.
Danish: Bravecto Plus var lige så effektivt som et andet lægemiddel, der indeholder emodepsid og praziquantel.
English: The content of one full Bravecto Plus pipette is applied to the cat's skin at the base of the skull.
Danish: Indholdet af en fuld Bravecto Plus-pipette påføres på kattens hud ved kraniebunden.
English: Fluralaner and moxidectin are already authorised on their own for the treatment of parasitic infestations.
Danish: Fluralaner og moxidectin er allerede godkendt hver for sig til behandling af parasitangreb.
English: Suitable gloves should be worn when handling or applying Bravecto Plus to cats.
Danish: Der bør bruges egnede beskyttelseshandsker, når Bravecto Plus håndteres eller påføres katte.
English: In case of skin contact, the affected area should be rinsed immediately with soap and water whilst in case of eye contact, the affected area should be rinsed immediately with water.
Danish: I tilfælde af hudkontakt bør det berørte område straks vaskes med sæbe og vand, og i tilfælde af øjenkontakt bør øjnene straks skylles med vand.
English: Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact, either when handling the product or when handling the treated animal.
Danish: Hududslæt, stikken og prikken eller følelsesløshed er indberettet for nogle få personer efter hudkontakt enten ved håndtering af produktet eller det behandlede dyr.
English: What is Bravecto Plus and what is it used for?
Danish: Hvad er Bravecto Plus, og hvad anvendes det til?
English: For more information about using Bravecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Bravecto Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Bravecto Plus is a veterinary medicine used in cats to treat mixed infestations with both ticks or fleas and ear mites and/or worms that live inside the body.
Danish: Bravecto Plus er et veterinærlægemiddel, der anvendes til katte til behandling af blandede angreb med både flåter eller lopper og øremider og/eller orme, der lever i kroppen.
English: Bravecto Plus was as effective as selamectin, another medicine already licensed for the treatment of ear mites in cats.
Danish: Bravecto Plus var lige så effektivt som selamectin, et andet lægemiddel, der allerede er godkendt til behandling af øremider hos katte.
English: In case of spillage on table or floor surfaces, excess Bravecto Plus spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
Danish: Hvis der spildes på bordet eller gulvet, bør overskydende Bravecto spot-on opløsning fjernes med en papirserviet og området vaskes med et rengøringsmiddel.
English: This means that it kills parasites present on the skin or in the fur or ears of animals, such as fleas, ticks and ear mites.
Danish: Det betyder, at det dræber parasitter, der lever på dyrets hud, i pelsen eller i ørerne, såsom lopper, flåter og øremider.
English: For the full list of side effects and restrictions of Bravecto Plus, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Bravecto Plus fremgår af indlægssedlen.
English: What are the risks associated with Bravecto Plus?
Danish: Hvilke risici er der forbundet med Bravecto Plus?
English: Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the cats' environment.
Danish: Fluralaner dræber lopperne, før de kan lægge æg, og begrænser dermed spredning af smitte til kattens omgivelser.
English: This results in paralysis and death of the parasites.
Danish: Dette bevirker, at parasitterne lammes eller dør.
English: In a field study of 167 cats infested with 5 or more ear mites, treatment with Bravecto Plus resulted in 94% of cats free from ear mites 14 days after treatment and 100% of cats free from ear mites 28 days after treatment.
Danish: I et feltstudie med 167 katte, der var angrebet af 5 eller flere øremider, bevirkede behandlingen med Bravecto Plus, at 94 % af kattene var fri for øremider 14 dage efter behandlingen, og 100 % af kattene var fri for øremider 28 dage efter behandlingen.
English: Why is Bravecto Plus authorised in the EU?
Danish: Hvorfor blev Bravecto Plus godkendt i EU?
English: Two laboratory studies involving healthy cats which were artificially infected with heartworm larvae showed Bravecto Plus to be 100% effective in preventing heartworm disease during 8 weeks.
Danish: To laboratoriestudier med raske katte, som kunstigt blev smittet med hjerteormlarver, viste, at Bravecto Plus var 100 % effektivt til at forebygge hjerteormsygdom i 8 uger.
English: Bravecto Plus is available as a spot-on solution in a pipette.
Danish: Bravecto Plus fås som spot-on-opløsning i en pipette.
English: • to prevent heartworm disease Bravecto Plus must only be used when there is a need to treat ticks or fleas and one or more of the parasites listed above.
Danish: Bravecto Plus må kun anvendes, når det er nødvendigt at behandle for flåter eller lopper og en eller flere af ovennævnte parasitter.
English: Bravecto Plus spot-on solution should be kept away from heat, sparks, open flames or other fire sources as it is highly flammable.
Danish: Bravecto Plus spot-on opløsning er meget brandfarlig og bør derfor holdes på afstand af varme, gnister, åben ild og andre antændelseskilder.
English: A field study involving cats naturally infested with ticks and/or fleas showed treatment with Bravecto Plus to reduce tick and flea counts by more than 95% and to be as effective as treatment using fipronil, another medicine already licensed for the treatment of ticks and fleas.
Danish: Et feltstudie, der omfattede katte med naturligt angreb af flåter og/eller lopper, viste, at behandling med Bravecto Plus reducerer antallet af flåter og lopper med over 95 %, og at det er lige så effektivt som fipronil, et andet lægemiddel, der allerede er godkendt til behandling af flåter og lopper.
English: Bravecto Plus contains the active substances fluralaner and moxidectin.
Danish: Bravecto Plus indeholder de aktive stoffer fluralaner og moxidectin.
English: Moxidectin kills parasites present in the body of animals such as roundworms, hookworms and heartworm as well as ear mites.
Danish: Moxidectin dræber parasitter, der findes i kroppen på dyr som f.eks. rundorm, hageorm og hjerteorm samt øremider.
English: • to treat roundworms and hookworms in the gut
Danish: • behandling af rundorme og hageorme i tarmene
English: The active substances in Bravecto Plus, fluralaner and moxidectin, work via different routes to kill parasites.
Danish: De aktive stoffer i Bravecto Plus, fluralaner og moxidectin, dræber parasitter på hver sin måde.
English: In order to be exposed to the active substance fluralaner, fleas and ticks must commence feeding on the cat.
Danish: For at lopper og flåter kan blive udsat for det aktive stof fluralaner, skal de først begynde at tage næring fra katten.
English: Another field study involving cats naturally infected with roundworms and/or hookworms showed treatment with Bravecto Plus to reduce faecal egg counts by 100%.
Danish: Et andet feltstudie, der omfattede katte med naturligt angreb af rundorm og/eller hageorm, viste, at behandling med Bravecto Plus reducerer antallet af æg i afføringen med 100 %.
English: Moxidectin causes paralysis and death of these parasites by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.
Danish: Moxidectin griber ind i udvekslingen af signaler mellem nervecellerne i parasitternes nervesystem (neurotransmission), hvorved de lammes og dør.
English: If skin reactions occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis der opstår hudreaktioner, bør der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Contact with the application site should be avoided until it is no longer noticeable.
Danish: Påføringsstedet bør først berøres, når det ikke længere er synligt i forhold til resten af huden.
English: How is Bravecto Plus used?
Danish: Hvordan anvendes Bravecto Plus?
English: What benefits of Bravecto Plus have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Bravecto Plus?
English: • to treat flea infestations.
Danish: • behandling af loppeangreb.
English: How does Bravecto Plus work?
Danish: Hvordan virker Bravecto Plus?
English: • to treat ear mite infestations
Danish: • behandling af øremideangreb
English: • to treat tick infestations
Danish: • behandling af flåtangreb
English: 2.4 Risks for pregnant women
Danish: 2.4 Risici for gravide kvinder
English: 2.5 Advice to doctors
Danish: 2.5 Råd til læger
English: No new substantial data were submitted.
Danish: Der blev ikke indsendt væsentlige nye oplysninger.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede undersøgelser af gravide kvinder.
English: Pregnant women should not handle the product.
Danish: Gravide må ikke håndtere produktet.
English: Precautionary measures:
Danish: Forebyggende foranstaltninger:
English: SCIENTIFIC CONCLUSIONS 1.
Danish: FAGLIGE KONKLUSIONER 1.
English: This is considered to be the appropriate way of expressing such an advice to doctors.
Danish: Det vurderes at være den rigtige måde at udtrykke et sådant råd til læger på.
English: 2.1 Systemic effect on sedation and hypotension
Danish: 2.1 Systemisk indvirkning på sedation og hypotension
English: Treatment should be supportive with appropriate intensive therapy.
Danish: Behandlingen skal understøttes med passende intensiv behandling.
English: Tijdsch.for Diergeneeskunde deel 131 Maart aflevering 6 2006.
Danish: Tijdsch.for Diergeneeskunde deel 131 Maart atlevring 6 2006.
English: Remove contaminated clothes.
Danish: Tag forurenet tøj af.
English: The recommendation to wear gloves when handling such a product was considered impractical for the veterinarian.
Danish: Anbefalingen om at bruge handsker ved håndtering af et sådant lægemiddel blev anset for at være upraktisk for dyrlæger.
English: The advice to doctors lists the potential clinical effects and suggested treatment.
Danish: Rådene til læger opremser mulige kliniske virkninger og foreslået behandling.
English: Furthermore, it is stated that it is not known whether Precedex is excreted in human milk.
Danish: Det fremgår desuden, at det ikke vides, om Precedex udskilles i human modermælk.
English: Such effects had never been reported after use of the product (detomidine).
Danish: Der havde aldrig været indberettet sådanne virkninger efter anvendelse af lægemidlet (detomidin).
English: Following this request, the CVMP during its meeting of 15-17 July 2008 restarted the procedure for evaluating the products indicated by the Member States.
Danish: Efter denne anmodning genoptog CVMP på sit møde den 15.-17. juli 2008 evalueringsproceduren vedrørende de lægemidler, der var angivet af medlemsstaterne.
English: It was considered that the term toxicity implies an overdose and since that will not always be the case, a modification was agreed upon.
Danish: Det blev vurderet, at termen toksicitet indebærer en overdosis, og eftersom dette ikke altid vil være tilfældet, enedes man om en let ændring.
English: A revised list of questions addressed to the Marketing Authorisation Holders concerned was adopted on 16 July 2008.
Danish: En revideret liste over spørgsmål til de pågældende indehavere af markedsføringstilladelser blev vedtaget den 16. juli 2008.
English: These products are used for sedation or analgesia in various species.
Danish: Lægemidlerne anvendes til sedation eller som analgesika til forskellige arter.
English: 2.3 Eye contact
Danish: 2.3 Øjenkontakt
English: The proposed precautionary measures relate to different user safety concerns.
Danish: De foreslåede forebyggende foranstaltninger vedrører forskellige spørgsmål om brugersikkerhed.
English: In addition, Article 78 of Directive 2001/82/EC applies only to the addition of precautionary measures in this procedure.
Danish: Artikel 78 i direktiv 2001/82/EF finder endvidere kun anvendelse på tilføjelser af forebyggende foranstaltninger i henhold til denne procedure.
English: Remove contaminated clothes that are in direct contact with skin.
Danish: Fjern kontamineret tøj, der er i direkte berøring med huden.
English: This resulted in a set of precautionary measures, which was agreed by all concerned Member States and the applicant at the time.
Danish: Dette medførte en række forebyggende foranstaltninger, som samtlige berørte medlemsstater og ansøgeren på det pågældende tidspunkt vedtog.
English: 4, 40472 Düsseldorf, GERMANY
Danish: 4 40472 Düsseldorf, TYSKLAND
English: Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), SPAIN
Danish: Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), SPANIEN
English: The safety of Precedex during labour and delivery has not been studied.
Danish: Sikkerheden ved Precedex under fødselsveer og fødsel er ikke undersøgt.
English: 2.2 Skin contact
Danish: 2.2 Hudkontakt
English: The CVMP concluded that the recommended general statements on precautionary measures are final recommendations given in response to the notification received from the Netherlands.
Danish: Udvalget konkluderede, at de anbefalede generelle udtalelser om forebyggende foranstaltninger er de endelige anbefalinger, der gives som svar på meddelelsen fra Nederlandene.
English: • Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact.
Danish: • Irritation, overfølsomhed, kontaktdermatitis og systemiske virkninger kan ikke udelukkes efter hudkontakt.
English: This resulted in the wording as proposed, which was agreed by all concerned Member States and the applicant.
Danish: Dette medførte den foreslåede formulering, som samtlige berørte medlemsstater og ansøgeren på det pågældende tidspunkt vedtog.
English: 161895/3 of 06.12.2002 (expired)
Danish: 161895/3 af 6.12.2002 (udløbet)
English: The maximal exposure was estimated to 0.3 ml Sedivet (3 mg romifidine).
Danish: Den maksimale dosis blev vurderet til at være 0,3 ml Sedivet (3 mg romifidin).
English: Ventricular arrhythmias have also been reported.
Danish: Der er også indberettet ventrikulær arytmi.
English: Having considered all available data, the CVMP concluded that the proposed precautionary measures regarding skin contact seem appropriate.
Danish: Efter at have behandlet alle foreliggende oplysninger konkluderede CVMP, at de foreslåede forebyggende foranstaltninger vedrørende hudkontakt forekommer hensigtsmæssige.
English: Precedex is a product containing dexmedetomidine, the active enantiomer of medetomidine, that is approved for use in humans in the United States.
Danish: Precedex er et lægemiddel, som indeholder dexmedetomidin, den aktive enantiomer af medetomidin, der er godkendt til humanmedicinsk brug i USA.
English: Oral exposure was not reported.
Danish: Der forelå ingen indberetninger om oral indtagelse.