FrancophonIA/ELRC3.0 huggingface dataset:
English: It can stop the growth of certain types of bacteria by attaching to the membrane surrounding the bacterial cell and upsetting the essential functions that keep the cell alive.
Danish: Det kan standse visse bakterietypers vækst ved at binde sig til membranen rundt om bakteriecellen og forstyrre de grundlæggende funktioner, der holder cellen i live.
English: Other information about Cubicin
Danish: Andre oplysninger om Cubicin
English: Prescribers should consider official guidance on the use of antibiotics.
Danish: De ordinerende læger skal følge de officielle retningslinjer for brug af antibiotika.
English: What measures are being taken to ensure the safe and effective use of Cubicin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cubicin?
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect how well treatment works;
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle, fordi den har spredt sig til det dybereliggende væv under huden, og at kirurgisk behandling derfor kan blive nødvendig, eller at patienten har andre lidelser, som kan have betydning for, hvor godt behandlingen virker.
English: Cubicin is an antibiotic medicine, which is used to treat the following bacterial infections:
Danish: Cubicin er et antibiotikum, der anvendes til behandling af følgende bakterieinfektioner:
English: Why is Cubicin approved?
Danish: Hvorfor blev Cubicin godkendt?
English: The decision to treat this type of infection with Cubicin should be based on the likelihood that the medicine will work against the infection and on advice from an expert;
Danish: Beslutningen om at behandle denne form for infektion med Cubicin skal baseres på sandsynligheden for, at lægemidlet virker mod infektionen, og på råd fra en ekspert.
English: Three main studies in adults and two in children aged between 1 and 17 years found that Cubicin was as effective as standard treatments at curing or improving infection.
Danish: Det er i tre hovedundersøgelser hos voksne og to hovedundersøgelser hos børn i alderen 1-17 år påvist, at Cubicin var lige så effektivt som standardbehandlinger til at helbrede eller bedre infektion.
English: What is Cubicin and what is it used for?
Danish: Hvad er Cubicin, og hvad anvendes det til?
English: The active substance in Cubicin, daptomycin, is an antibiotic that belongs to the group ‘lipopeptides'.
Danish: Det aktive stof i Cubicin, daptomycin, er et antibiotikum, som tilhører gruppen af "lipopeptider".
English: • bacteraemia (infection of the blood) caused by S. aureus.
Danish: • bakteriæmi (infektion i blodet) forårsaget af S. aureus.
English: The duration of treatment with Cubicin depends on the risk of complications and official recommendations.
Danish: Behandlingsvarigheden afhænger af risikoen for komplikationer og af de officielle anbefalinger.
English: Cubicin is given by infusion lasting 60 minutes in children aged 1 to 6 years and 30 minutes in those aged above 7 years.
Danish: Cubicin gives som infusion over 60 minutter hos børn i alderen 1-6 år og over 30 minutter hos børn fra 7 år og opefter.
English: What are the risks associated with Cubicin?
Danish: Hvilke risici er der forbundet med Cubicin?
English: In the first two studies involving 1,118 adults with complicated skin and soft tissue infections (mainly wound infections and major abscesses), Cubicin was effective in 67% of patients in one study and in 85% in the other.
Danish: I de første to undersøgelser, hvor 1 118 voksne med kompliceret hud- eller blødvævsinfektion (hovedsageligt sårinfektioner og større abscesser), var Cubicin effektivt hos 67 % af patienterne i én undersøgelse og hos 85 % i den anden.
English: The European Medicines Agency decided that Cubicin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Cubicin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cubicin.
English: Cubicin contains the active substance daptomycin.
Danish: Cubicin indeholder det aktive stof daptomycin.
English: Effectiveness varied between the two studies because of differences in the types of patients and infections being treated.
Danish: Virkningen varierede mellem de to undersøgelser, da patienttyperne og de behandlede infektionstyper ikke var de samme.
English: The third study involved 246 adults with bacteraemia caused by S. aureus, including 35 who also had right-sided infective endocarditis.
Danish: Den tredje undersøgelse omfattede 246 voksne med bakteriæmi forårsaget af S. aureus, herunder 35, der også havde højresidig infektiøs endocarditis.
English: Standard treatments comprised use of antibiotics such as vancomycin, a penicillin (including oxacillin, cloxacillin, flucloxacillin and nafcillin) or a cephalosporin.
Danish: Standardbehandlinger omfattede brugen af antibiotika som f.eks. vancomycin, penicillin (herunder oxacillin, cloxacillin, flucloxacillin og nafcillin) eller cephalosporin.
English: The first study in children and adolescents involved 396 patients with complicated skin and soft tissue infections without bacteraemia.
Danish: Den første undersøgelse hos børn og unge omfattede 396 patienter med komplicerede infektioner i hud eller blødt væv uden bakteriæmi.
English: There was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and softtissue infections.
Danish: Der forelå ikke tilstrækkelig dokumentation til at kunne understøtte brugen af Cubicin til behandling af bakteriæmi hos patienter, som ikke har enten højresidig infektiøs endocarditis eller komplicerede infektioner i hud eller blødt væv.
English: It is not intended to provide practical advice on how to use Cubicin.
Danish: Det er ikke en praktisk vejledning i, hvordan Cubicin bør anvendes.
English: • complicated infections of the skin and soft tissue below the skin in patients from 1 year of age.
Danish: • komplicerede hudinfektioner og infektioner i det bløde væv under huden hos patienter fra 1 år og opefter.
English: The second study in children and adolescents involved 73 patients with bacteraemia caused by S. aureus.
Danish: Den anden undersøgelse hos børn og unge omfattede 73 patienter med bakteriæmi forårsaget af S. aureus.
English: It is used in adults when the bacteraemia is associated with either of the two infections above, or in adolescents and children from 1 year of age when the bacteraemia is associated with complicated infections of the skin and soft tissue.
Danish: Det anvendes hos voksne, når bakteriæmien er forbundet med en af de to førnævnte infektioner, eller hos børn og unge fra 1 år og opefter, når bakteriæmien er forbundet med komplicerede infektioner i hud og blødt væv.
English: The most common side effects with Cubicin (seen in between 1 and 10 patients in 100) are infections caused by fungi (moulds and yeasts), urinary tract infections (infection of the structures that carry urine), Candida infection (a fungal infection), anaemia (low red blood cell counts), anxiety, insomnia (difficulty sleeping), dizziness, headache, hypertension (high blood pressure), hypotension (low blood pressure), gastrointestinal and abdominal pain (belly ache), nausea (feeling sick), vomiting, constipation, diarrhoea, flatulence (gas), bloating and distension (feeling as if the tummy is full), rash, pruritus (itching), pain in the limbs (arms or legs), infusion site reactions, pyrexia (fever), asthenia (weakness), abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage).
Danish: De hyppigste bivirkninger ved Cubicin (som optræder hos mellem 1 og 10 patienter ud af 100) er svampeinfektioner (skimmel- og gærsvampe), urinvejsinfektioner, candida-infektion (en svampeinfektion), lavt antal røde blodceller, angst, søvnbesvær, svimmelhed, hovedpine, forhøjet blodtryk, for lavt blodtryk, gastrointestinale smerter og mavesmerter, kvalme, opkastning, forstoppelse, diarré, luft i maven, oppustethed og udspilet mave, udslæt, kløe, smerte i arme eller ben, reaktioner på infusionsstedet, feber, kraftesløshed, unormale leverprøver og forhøjede blodkoncentrationer af et enzym kaldet CPK (en markør for muskelskader).
English: Higher doses (between 7 and 12 mg/kg once a day) are used if the skin or soft tissue infection is associated with bacteraemia.
Danish: Højere doser (7-12 mg/kg én gang dagligt) anvendes, hvis hud- eller blødvævsinfektionen er forbundet med bakteriæmi.
English: For the full list of side effects and restrictions with Cubicin, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cubicin fremgår af indlægssedlen.
English: • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus) in adults.
Danish: • højresidig infektiøs endocarditis (betændelse i hinden eller klapperne i højre side af hjertet) forårsaget af bakterien Staphylococcus aureus (S. aureus) hos voksne.
English: For more information about treatment with Cubicin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cubicin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that markets Cubicin will provide all doctors who are expected to use Cubicin with a dosage card to ensure the safe use of the medicine.
Danish: Den virksomhed, der markedsfører Cubicin, skal udlevere et doseringskort til alle læger for at sikre risikofri brug af lægemidlet.
English: Cubicin is given into a vein as an infusion lasting 30 minutes or as an injection lasting 2 minutes.
Danish: Cubicin gives som infusion i en blodåre over 30 minutter eller som en injektion over to minutter.
English: Serious side effects include hypersensitivity (allergic) reactions, eosinophilic pneumonia (infection of the lungs), drug rash with eosinophilia and systemic symptoms (DRESS, a severe reaction affecting the skin, blood and internal organs), angioedema (rapid swelling of deeper skin tissues) and rhabdomyolysis (breakdown of muscle fibres).
Danish: Alvorlige bivirkninger er overfølsomhedsreaktioner (allergiske reaktioner), eosinofil lungebetændelse (lungeinfektion), medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS, en alvorlig reaktion, der berører huden, blodet og de indre organer), angioødem (hurtig hævelse af de dybere hudlag) og rhabdomyolyse (nedbrydning af muskelfibre).
English: Cubicin is available as a powder that is made up into a solution for injection or infusion (drip) into a vein.
Danish: Cubicin fås som et pulver, der blandes til en opløsning til injektion eller infusion (drop i en vene).
English: In the group with endocarditis, treatment was successful in 42% (8 out of 19) of the patients receiving Cubicin compared with 44% (7 out of 16) of the patients receiving standard treatment.
Danish: I gruppen med endocarditis virkede behandlingen hos 42 % af de Cubicin-behandlede patienter (8 ud af 19) sammenholdt med 44 % (7 ud af 16) af de patienter, der fik standardbehandling.
English: Treatment was successful in 88% (227 out of 257) of the patients receiving Cubicin compared with 86% (114 out of 132) receiving standard treatment.
Danish: Behandlingen virkede hos 88 % (227 ud af 257) af de patienter, der fik Cubicin, sammenholdt med 86 % (114 ud af 132) af de patienter, der fik standardbehandling.
English: What benefits of Cubicin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cubicin?
English: Treatment was successful in 88% (45 out of 51) of the patients receiving Cubicin compared with 77% (17 out of 22) receiving standard treatment.
Danish: Behandlingen virkede hos 88 % (45 ud af 51) af de patienter, der fik Cubicin, sammenholdt med 77 % (17 ud af 22) af de patienter, der fik standardbehandling.
English: For practical information about using Cubicin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cubicin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For endocarditis and for skin or soft tissue infection with bacteraemia, the dose is 6 mg/kg once a day.
Danish: Ved endocarditis og infektioner i hud eller blødt væv med bakteriæmi er dosis 6 mg/kg én gang dagligt.
English: How is Cubicin used?
Danish: Hvordan anvendes Cubicin?
English: How does Cubicin work?
Danish: Hvordan virker Cubicin?
English: In adults, for skin or soft tissue infections without bacteraemia, Cubicin is given at a dose of 4 mg/kg body weight once a day.
Danish: Hos voksne, der har infektion i hud eller blødt væv, men ikke bakteriæmi, gives Cubicin i en dosis på 4 mg/kg legemsvægt én gang dagligt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cubicin have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cubicin.
English: In children the dose of Cubicin for skin or soft tissue infection without bacteraemia depends on the child's age and ranges between 5 and 10 mg/kg once a day.
Danish: Hos børn er Cubicin-dosen til behandling af hud- eller blødvævsinfektion uden bakteriæmi 5-10 mg/kg én gang dagligt afhængigt af barnets alder.
English: It also depends on the use and the way it is given.
Danish: Den afhænger også af anvendelsen og indgivelsesmetoden.
English: The full EPAR for Cepedex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cepedex findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cepedex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cepedex.
English: The European Commission granted a marketing authorisation valid throughout the EU for Cepedex on 13 December 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cepedex den 13/12/2016.
English: Cepedex is an alpha2-adrenoceptor agonist.
Danish: Cepedex er en alfa-2-adrenoceptor-agonist.
English: The Committee recommended that Cepedex be approved for use in the EU.
Danish: Udvalget anbefalede, at Cepedex godkendes til anvendelse i EU.
English: • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia).
Danish: • Ved udførelse af mildt til moderat smertefulde procedurer og undersøgelser, som kræver, at dyret holdes fast eller beroliges, og at det gøres mindre følsomt over for smerter (analgesi).
English: Cepedex dexmedetomidine
Danish: Cepedex dexmedetomidin
English: It works by attaching to receptors known as alpha2-adrenergic receptors and preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Danish: Det virker ved at binde sig til receptorer kaldet alfa-2-adrenerge receptorer og forhindre frigivelsen af neurotransmitteren noradrenalin fra kroppens nerveceller.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom sedation and analgesia depend on the dose that is used.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The company provided information on the quality and manufacture of Cepedex.
Danish: Virksomheden fremlagde data om kvaliteten og fremstillingen af Cepedex.
English: Cepedex is a medicine used to sedate (calm down) dogs and cats in the following situations:
Danish: Cepedex er et lægemiddel, som anvendes til at berolige hunde og katte i følgende situationer:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Cepedex has been shown to have comparable quality to Dexdomitor.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Cepedex er af sammenlignelig kvalitet med Dexdomitor.
English: For dogs the dose depends on their body surface area (calculated using bodyweight) and in cats it is based on bodyweight.
Danish: Hos hunde afhænger dosis af dyrets legemsoverflade (beregnet på baggrund af legemsvægt), og hos katte baseres dosis på legemsvægt.
English: Cepedex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).
Danish: Cepedex kan også anvendes til smertelindring og dyb beroligelse hos hunde ved udførelse af medicinske procedurer og mindre kirurgiske indgreb, hvor det bruges i kombination med butorphanol (et beroligende og bedøvende middel).
English: Cepedex contains the active substance dexmedetomidine and is a ‘generic medicine'.
Danish: Cepedex indeholder det aktive stof dexmedetomidin og er et "generisk lægemiddel".
English: What are the benefits and risks of Cepedex?
Danish: Hvilke fordele og risici er der forbundet med Cepedex?
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Danish: Dexmedetomidin er nært beslægtet med et andet stof, medetomidin, som også anvendes til beroligelse af dyr, og som har været anvendt i lægemidler til dyr i mange år.
English: Cepedex is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
Danish: Cepedex anvendes til ikkeinvasive procedurer, hvilket betyder, at proceduren ikke indebærer brud på huden eller en kropskavitet.
English: This means that Cepedex is similar to a ‘reference medicine' already authorised in the EU called Dexdomitor.
Danish: Det betyder, at Cepedex svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Dexdomitor.
English: What is Cepedex and what is it used for?
Danish: Hvad er Cepedex, og hvad anvendes det til?
English: • as premedication before inducing general anaesthesia.
Danish: • Ved præmedicinering forud for fuld bedøvelse.
English: It is not intended to provide practical advice on how to use Cepedex.
Danish: Det er ikke en praktisk vejledning i, hvordan Cepedex bør anvendes.
English: In dogs, Cepedex is given by injection into a vein or a muscle.
Danish: Hos hunde gives Cepedex ved injektion i en vene eller en muskel.
English: No additional studies were needed as Cepedex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as the reference medicine, Dexdomitor.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Cepedex er et generisk lægemiddel, der indgives ved injektion, og som har samme sammensætning og indeholder det samme aktive stof som referencelægemidlet, Dexdomitor.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cepedex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when giving Cepedex.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cepedex, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret, når Cepedex indgives.
English: In cats, it is given by injection into a muscle.
Danish: Hos katte gives Cepedex ved injektion i en muskel.
English: Other information about Cepedex?
Danish: Andre oplysninger om Cepedex
English: Why is Cepedex approved?
Danish: Hvorfor er Cepedex blevet godkendt?
English: Because Cepedex is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Danish: Da Cepedex er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, er forholdsreglerne de samme som for referencelægemidlet.
English: Because Cepedex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Cepedex er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Cepedex is available as a solution for injection and can only be obtained with a prescription.
Danish: Cepedex fås som injektionsvæske, opløsning, og udleveres kun efter recept.
English: For more information about treatment with Cepedex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Cepedex, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Cepedex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Cepedex, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The duration and depth of
Danish: Varigheden og dybden af beroligelsen og bedøvelsen afhænger af, hvilken dosis der anvendes.
English: How has Cepedex been studied?
Danish: Hvordan er Cepedex blevet undersøgt?
English: How is Cepedex used?
Danish: Hvordan anvendes Cepedex?
English: How does Cepedex work?
Danish: Hvordan virker Cepedex?
English: 1 pre-filled syringe of 150 mg + 2 needles, 1 prefilled syringe 100 mg + 2 needles
Danish: 1 fyldt injektionssprøjte 150 mg + 2 kanyler, 1 fyldt injektionssprøjte 100 mg + 2 kanyler
English: Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Indgivelsesvej Emballage Paknings-størrelse
English: This product may be harmful for the unborn child.
Danish: Dette produkt kan være skadeligt for det ufødte barn.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/05/2019
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20/05/2019
English: Pull out the needle and release the skin.
Danish: Træk kanylen ud og giv slip på huden
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/239/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/19/239/001
English: Iron (III)
Danish: Jern(III)
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Lot, {nummer}
English: Frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Danish: Hyppig og gentagen brug af antiprotozo-midler fra samme gruppe kan føre til resistensudvikling.
English: The active substances in Baycox Iron are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: De aktive substanser i Baycox Iron er godkendte substanser som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Hygienic measures may reduce the risk of porcine coccidiosis.
Danish: Hygiejniske foranstaltninger kan reducere risikoen for coccidiose.
English: The preferred injection site is the neck area (see illustration below).
Danish: Det foretrukne injektionssted er nakkeområdet (se illustration nedenfor).
English: To ensure the correct dosage, the piglets' body weight should be determined as accurately as possible.
Danish: For at sikre korrekt dosis bør pattegrisenes legemsvægt bestemmes så præcist som muligt.