FrancophonIA/ELRC3.0 huggingface dataset:
English: This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Danish: Dette antivirale lægemiddel blokerer enzymet integrase, som hiv-virus behøver til at danne nye kopier af sig selv i kroppen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Triumeq, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Triumeq, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Triumeq is available as tablets (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudine) and the recommended dose is one tablet a day, taken with or without food.
Danish: Triumeq leveres som tabletter (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudin), og den anbefalede dosis er én tablet dagligt.
English: Regarding Triumeq's safety profile, this was expected to be similar to the safety profile of the single components and comparable to that of other HIV treatments.
Danish: Triumeqs sikkerhedsprofil forventedes at ligne de enkelte bestanddeles sikkerhedsprofiler og være sammenlignelig med andre hiv-behandlingers sikkerhedsprofil.
English: Triumeq can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Danish: Triumeq fås kun på recept, og behandlingen bør kun ordineres af en læge med erfaring i behandling af hiv-infektion.
English: Triumeq contains three active substances: dolutegravir, abacavir and lamivudine.
Danish: Triumeq indeholder tre aktive stoffer: dolutegravir, abacavir og lamivudin.
English: Patients were either given the Triumeq combination or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
Danish: Patienterne fik enten kombinationen Triumeq eller en anden kombination af tre lægemidler (Atripla), der ikke indeholdt en integrasehæmmer.
English: For more information about treatment with Triumeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Triumeq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The other two active substances, abacavir and lamivudine, are nucleoside reversetranscriptase inhibitors (NRTIs).
Danish: De to andre aktive stoffer, abacavir og lamivudin, er nukleosid-reverse-transcriptase-hæmmere (NRTI).
English: What are the risks associated with Triumeq?
Danish: Hvilke risici er der forbundet med Triumeq?
English: The company also looked at the way Triumeq was absorbed in the body in comparison with two separate tablets (dolutegravir and abacavir/lamivudine) containing the three medicines that make it up.
Danish: Virksomheden undersøgte desuden, hvordan Triumeq blev optaget i kroppen sammenlignet med to separate tabletter (dolutegravir og abacavir/lamivudin), der indeholdt de samme tre lægemidler, som Triumeq består af.
English: The CHMP also considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach.
Danish: CHMP tog desuden i betragtning, at Triumeq både kan tages med et måltid og mellem måltiderne; dette er en yderligere fordel sammenlignet med andre tilsvarende lægemidler, der skal tages enten sammen med et måltid eller på tom mave.
English: The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene.
Danish: CHMP bemærkede desuden, at kombinationen af dolutegravir, abacavir og lamivudin i én enkelt tablet er en ekstra behandlingsmulighed for patienter, der er smittet med hiv og er uden genet HLA-B (type
English: Triumeq is an antiviral medicine used to treat patients with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: Triumeq er et lægemiddel mod virus (et antiviralt lægemiddel), der anvendes til behandling af patienter med hiv (humant immundefektvirus), som er årsag til aids (erhvervet immundefektsyndrom).
English: One of the active substances in Triumeq, dolutegravir, is an integrase inhibitor.
Danish: Det ene aktive stof i Triumeq, dolutegravir, er en integrasehæmmer.
English: Triumeq must not be used together with dofetilide, a medicine used to control cardiac arrhythmia (unstable heartbeat).
Danish: Triumeq må ikke anvendes sammen med lægemidlet dofetilid, der anvendes mod ustabil hjerterytme (kardial arytmi).
English: In addition, the company that markets Triumeq will provide educational material for healthcare professionals expected to prescribe Triumeq that addresses the risk of abacavir-associated hypersensitivity.
Danish: Desuden skal den virksomhed, der markedsfører Triumeq, udlevere oplysningsmateriale til de sundhedspersoner, der ventes at ordinere Triumeq.
English: For practical information about using Triumeq, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Triumeq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Triumeq reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym mindsker Triumeq hiv-indholdet i blodet og holder det nede.
English: For the full list of restrictions with Triumeq, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger med Triumeq fremgår af indlægssedlen.
English: How is Triumeq used?
Danish: Hvordan anvendes Triumeq?
English: For the full list of all side effects reported with Triumeq, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Triumeq fremgår af indlægssedlen.
English: How does Triumeq work?
Danish: Hvordan virker Triumeq?
English: What benefits of Triumeq have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Triumeq?
English: It is important to treat these types of conditions as soon as possible.
Danish: Det er vigtigt, at disse typer tilstande behandles hurtigst muligt.
English: The procedure should be carried out under sterile conditions.
Danish: Proceduren skal foregå under sterile forhold.
English: This causes the gradual loss of the central part of a person's vision.
Danish: Dette medfører gradvist tab af den centrale del af en persons syn.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Macugen on 31 January 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Macugen den 31. januar 2006.
English: The full EPAR for Macugen can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Macugen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Macugen.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Macugen.
English: The symptoms of these conditions and instructions about what to do if a patient has these symptoms are explained in the package leaflet.
Danish: Symptomerne på disse tilstande og vejledning i, hvad man skal gøre, hvis en patient udviser disse symptomer, er beskrevet i indlægssedlen.
English: This improvement lasted for two years in patients who were given Macugen.
Danish: Forbedringen varede i to år hos patienter, som blev behandlet med Macugen.
English: The main measure of effectiveness was the proportion of patients losing less than 15 letters in a standard eye test.
Danish: Virkningen blev hovedsagelig målt på andelen af patienter, som mistede under 15 bogstaver i en standardsynstest.
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 Macugen.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Macugen.
English: Macugen is given as one injection of 0.3 mg into the affected eye every six weeks.
Danish: Macugen indgives som én injektion på 0,3 mg i det berørte øje hver sjette uge.
English: It must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes).
Danish: Det må ikke anvendes til patienter, som har eller formodes at have okulære eller periokulære infektioner (infektioner i eller omkring øjnene).
English: EPAR summary for the public pegaptanib
Danish: EPAR - sammendrag for offentligheden pegaptanib
English: Macugen has been studied in two main clinical studies involving a total of 1,190 patients and lasting up to two years.
Danish: Macugen er blevet undersøgt i to hovedundersøgelser af i alt 1 190 patienter med en varighed af op til to år.
English: An aptamer is a single strand of molecules called nucleotides that has been designed to attach to a specific molecule in the body.
Danish: En aptamer er en enkelt streng af molekyler kaldet nukleotider, som er udformet til at binde sig til et specifikt molekyle i kroppen.
English: The 3 mg dose did not bring any additional benefit.
Danish: Dosen på 3 mg forbedrede ikke virkningen.
English: The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Danish: Macula giver det centrale syn, som man bruger til hverdag, når man f.eks. fører motorkøretøj, læser og genkender ansigter.
English: The active substance in Macugen, pegaptanib, is an ‘aptamer'.
Danish: Det aktive stof i Macugen, pegaptanib, er en ”aptamer”.
English: What measures are being taken to ensure the safe use of Macugen?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Macugen?
English: Other information about Macugen
Danish: Øvrige oplysninger om Macugen:
English: The company that makes Macugen will provide educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Danish: Den virksomhed, som fremstiller Macugen, udleverer oplysningsmateriale til læger (for at minimere de risici, der er forbundet med injektionen i øjet) og til patienter (så de kan genkende eventuelle alvorlige bivirkninger og vide, hvornår de skal søge akut behandling hos deres læge).
English: For more information about treatment with Macugen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Macugen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: After one year of treatment, about 70% of the patients treated with Macugen 0.3 and 1 mg lost less than 15 letters in the eye test compared with about 55% of those who received the sham injection.
Danish: Efter ét års behandling mistede cirka 70 % af de patienter, der blev behandlet med Macugen 0,3 mg og 1 mg, under 15 bogstaver i synstesten, sammenlignet med cirka 55 % af de patienter, som modtog skininjektionen.
English: Antibiotic eye drops may also be given before and after the Macugen injection, to prevent eye infection.
Danish: Der kan også indgives antibiotiske øjendråber før og efter Macugen-injektionen for at forebygge infektion i øjet.
English: Before each injection, a local anaesthetic will be given to reduce or prevent any pain from the injection.
Danish: Før hver injektion indgives lokalbedøvelse for at reducere eller forebygge eventuelle smerter i forbindelse med injektionen.
English: Macugen is used to treat adults with the ‘wet' form of age-related macular degeneration (AMD).
Danish: Macugen anvendes til behandling af voksne med den ”våde” form af aldersrelateret maculadegeneration (AMD).
English: The patients were given either Macugen (0.3 mg, 1 mg or 3 mg) or a ‘sham' injection.
Danish: Patienterne fik enten Macugen (0,3 mg, 1 mg eller 3 mg) eller en skininjektion.
English: As Macugen when given by intravitreal injection can raise the pressure and cause bleeding within the eye, patients should be appropriately monitored after each injection.
Danish: Idet Macugen, når det indgives som intravitreal injektion, kan øge trykket og forårsage blødning i øjet, skal patienter overvåges nøje efter hver injektion.
English: If, after two injections, no benefit is seen on the patient's eyesight, the treatment should be stopped or withheld.
Danish: Hvis patientens syn ikke forbedres efter to injektioner, bør behandlingen afbrydes helt eller midlertidigt.
English: The CHMP decided that Macugen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Macugen opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Macugen.
English: The wet form of AMD is caused by the abnormal growth of blood vessels under the macula, which may leak fluid and blood and cause swelling.
Danish: Våd AMD skyldes abnorm vækst i blodkarrene under macula, som kan afgive væske og blod og forårsage hævelse.
English: What is the risk associated with Macugen?
Danish: Hvilken risiko er der forbundet med Macugen?
English: The CHMP noted that in patients with wet AMD Macugen 0.3 mg had similar effects on vision loss as Macugen 1 mg, therefore the lower dose was selected for approval.
Danish: CHMP bemærkede, at hos patienter med våd AMD havde Macugen 0,3 mg same virkning på synstab som Macugen 1 mg, og derfor blev den laveste dosis valgt til godkendelsen.
English: This is a procedure that is similar to a Macugen injection, but with no Macugen and no needle, in which a syringe is pressed against the eye but nothing is actually injected.
Danish: Dette er en procedure, som ligner en Macugen-injektion - men uden Macugen og uden kanyle - hvor en injektionssprøjte presses mod øjet, men intet stof rent faktisk indgives.
English: The most common side effects with Macugen (seen in more than 1 patient in 10) are anterior chamber inflammation (inflammation of the front part of the eye), pain in the eye, raised intraocular pressure (increased pressure inside the eye), punctate keratitis (small marks on the eye surface) and vitreous floaters or opacities (small particles or spots in the vision).
Danish: De hyppigste bivirkninger ved Macugen (som optræder hos flere end 1 ud af 10 patienter) er betændelse i øjets forkammer (den forreste del af øjet), øjensmerter, forhøjet intraokulært tryk (forhøjet tryk i øjet), punktformig keratitis (små mærker på øjets overflade) og pletter i synsfeltet (”flyvende fluer”) eller uklarheder (små partikler eller pletter i synsfeltet).
English: Pegaptanib has been designed to attach to and block a protein called vascular endothelial growth factor (VEGF).
Danish: Pegaptanib er udformet, så det binder sig til og blokerer et protein, der kaldes vaskulær endotelial vækstfaktor (VEGF).
English: This disease affects the central part of the retina called the macula at the back of the eye.
Danish: Sygdommen angriber den centrale del af nethinden, som kaldes macula, bagest i øjet.
English: Macugen must not be used in people who are hypersensitive (allergic) to pegaptanib or any of the other ingredients.
Danish: Macugen må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for pegaptanib eller andre af indholdsstofferne.
English: In the body, VEGF is involved in the growth of blood vessels and in making them more permeable.
Danish: I kroppen er VEGF med til at få blodkarrene til at vokse og gøre dem mere gennemtrængelige.
English: Why has Macugen been approved?
Danish: Hvorfor blev Macugen godkendt?
English: This reduces the growth of blood vessels in the eye and controls the leakage and swelling.
Danish: Dette hæmmer væksten i blodkarrene i øjet og regulerer væskeudsivningen og hævningen.
English: For the full list of all side effects reported with Macugen, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Macugen fremgår af indlægssedlen.
English: Macugen is a solution for injection into the eye that contains the active substance pegaptanib.
Danish: Macugen er en væske, opløsning, til injektion i øjet, som indeholder det aktive stof pegaptanib.
English: Macugen should only be given by an ophthalmologist (eye specialist) who is experienced in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Danish: Macugen må kun indgives af en oftalmolog (speciallæge i øjensygdomme) med erfaring i at give intravitreale injektioner (injektioner i glaslegemet, den geléagtige væske i øjet).
English: What is Macugen?
Danish: Hvad er Macugen?
English: What is Macugen used for?
Danish: Hvad anvendes Macugen til?
English: How has Macugen been studied?
Danish: Hvordan blev Macugen undersøgt?
English: What benefit has Macugen shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Macugen?
English: The pre-filled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel a certain volume and ensure the injection of the correct dose.
Danish: Derfor skal lægen, når injektionen klargøres, fjerne en vis volumen og sikre, at der indgives den korrekte dosis.
English: Pegaptanib injected into the eye blocks VEGF.
Danish: Pegaptanib, givet som injektion i øjet, blokerer VEGF.
English: Sometimes, endophthalmitis (an infection inside the eye), vitreous haemorrhage (bleeding into the eye) and retinal damage can occur after Macugen treatment.
Danish: I nogle tilfælde kan der efter behandling med Macugen opstå endoftalmitis (en infektion inden i øjet), blødning i glaslegemet og beskadigelse af nethinden.
English: How is Macugen used?
Danish: Hvordan anvendes Macugen?
English: It is available as a prefilled syringe.
Danish: Det leveres som en fyldt injektionssprøjte.
English: How does Macugen work?
Danish: Hvordan virker Macugen?
English: The Marketing Authorisation was subsequently renewed.
Danish: Markedsføringstilladelsen blev efterfølgende fornyet.
English: Safety of the product was satisfactorily demonstrated.
Danish: Produktets sikkerhed blev tilfredsstillende påvist.
English: This summary was last updated in August 2008.
Danish: Dette sammendrag blev sidst ajourført i 08-2008.
English: The vaccine is given by intramuscular injection.
Danish: Vaccinen gives ved intramuskulær injektion.
English: The European Commission granted a marketing authorisation, valid throughout the European Union, for Neocolipor to Mérial on 9 August 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neocolipor til Mérial den 9. august 2002.
English: Vaccination may cause a slight rise in the animal's body temperature (less than 1.5°C during a maximum period of 24 hours).
Danish: Vaccinationen kan forårsage en let forøgelse af dyrets kropstemperatur (mindre end 1,5°C i højst 24 timer).
English: Re-vaccination was shown to be effective at the intervals recommended.
Danish: Genvaccination viste sig at være effektiv ved de anbefalede intervaller.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEOCOLIPOR EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NEOCOLIPOR EPAR - sammendrag for offentligheden
English: The results presented showed statistical significance between vaccinates and non-vaccinates and thus demonstrated the efficacy of the vaccine.
Danish: Resultaterne viste statistiske forskelle mellem vaccinerede og ikke-vaccinerede dyr og påviste således vaccinens virkning.
English: Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (|K88 ad) F5 (K99) F6 (987P) and F41.
Danish: Neocolipor indeholder inaktiverede stammer af E. coli med adhesinerne F4ab (K88ab), F4ac (K88ac), F4ad (|K88 ad) F5 (K99) F6 (987P) og F41.
English: Safety data were also presented for the recommended use of the product both under laboratory conditions and in the field.
Danish: Der blev også fremlagt sikkerhedsdata for den anbefalede anvendelse af produktet, både i laboratorier og i felten.
English: A booster vaccination is given 2 weeks prior to each subsequent farrowing.
Danish: En booster-vaccination gives 2 uger før hver efterfølgende faring.
English: Gilts are animals which have produced fewer than two litters.
Danish: Gylte er dyr, som har fået mindre end to kuld unger.
English: Other information about Neocolipor:
Danish: Andre oplysninger om Neocolipor:
English: In the case of accidental self injection, seek medical advice immediately and show the package insert or label to a physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Neocolipor had been shown to be effective in the reduction of neonatal enterotoxicosis in piglets.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Neocolipor er effektiv til reduktion af neonatal enterotoxicose hos pattegrise.
English: A number of trials were carried out in both the laboratory and in the field in order to assess the efficacy of the product.
Danish: Der blev gennemført en række laboratorieundersøgelser og feltundersøgelser for at vurdere lægemidlets virkning.
English: Vaccination of the mother animal (sows and gilts) enables the offspring to receive a passive immunity during their first days of life against neonatal enterotoxicosis caused by E. coli strains carrying the adhesins F4, F5, F6 and F41.
Danish: Vaccinen gives til moderen (både søer og gylte), så afkommet i løbet af de første levedage opnår passiv immunitet over for neonatal enterotoxicose forårsaget af stammer af E. coli med adhesinerne F4, F5, F6 og F41.
English: Neocolipor is an inactivated vaccine intended to be used to reduce neonatal enterotoxicosis (a bacterial infection caused by strains of E.coli) in very young piglets.
Danish: Neocolipor er en inaktiveret vaccine beregnet til at reducere neonatal enterotoxicose (en bakterieinfektion forårsaget af stammer af E. coli) hos pattegrise.
English: The vaccine is intended for use 5-7 weeks before the birth of the litter (farrowing) with a second vaccination at 2 weeks prior to farrowing.
Danish: Vaccinen skal efter hensigten anvendes 5-7 uger før faring og endnu en gang 2 uger før faring.
English: Zero days (the vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated animals at the recommended dose).
Danish: Vaccinen indeholder ikke stoffer, der kan udgøre en risiko for forbrugere, som spiser kød fra dyr, der er vaccineret med den anbefalede dosis.
English: Why has Neocolipor been approved?
Danish: Hvorfor blev Neocolipor godkendt?
English: Neocolipor is administered to female pigs - both sows and gilts - in order to immunise their offspring against neonatal enterotoxicosis.
Danish: Neocolipor gives til søer (både søer og gylte) for at immunisere deres afkom over for neonatal enterotoxicose.
English: What is Neocolipor?
Danish: Hvad er Neocolipor?
English: What is Neocolipor used for?
Danish: Hvad anvendes Neocolipor til?
English: What are the side-effects of Neocolipor?
Danish: Hvilke bivirkninger er der ved Neocolipor?
English: What benefit has Neocolipor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Neocolipor?