FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on the prescription status of this product can be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for dette lægemiddel findes på etiketten/den ydre emballage.
English: Veraflox is a medicine that contains pradofloxacin.
Danish: Veraflox er et lægemiddel, der indeholder pradofloxacin.
English: It can also be used in conjunction with dental treatment in dogs with severe gum infections.
Danish: Det kan også anvendes i kombination med tandbehandling til hunde med svære gummesygdomme.
English: The active substance in Veraflox, pradofloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Danish: Det aktive stof i Veraflox, pradofloxacin, tilhører en gruppe af antibiotika kaldet "fluoroquinoloner".
English: Pradofloxacin works by blocking some of the enzymes that are important in allowing bacteria to make copies of their DNA.
Danish: Pradofloxacin virker ved at blokere nogle af de enzymer, som spiller en vigtig rolle for, at bakterier kan lave kopier af deres eget DNA.
English: By blocking two enzymes called ‘DNA gyrase' and ‘topoisomerase IV', pradofloxacin stops the bacteria from growing and multiplying.
Danish: Ved at blokere to enzymer kaldet "DNA-gyrase" og "topoisomerase IV" forhindrer pradofloxacin bakterierne i at vokse og formere sig.
English: Wash hands after using these products.
Danish: Vask hænder efter brug af Veraflox-lægemidler.
English: It is available as brownish tablets containing 15 mg, 60 mg or 120 mg pradofloxacin, and as a yellowish/beige coloured oral suspension, containing 25 mg/ml pradofloxacin.
Danish: Det fås som brunlige tabletter indeholdende 15 mg, 60 mg eller 120 mg pradofloxacin og som gullig til beige oral suspension indeholdende 25 mg/ml pradofloxacin.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP), on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: In all of the studies the effectiveness of Veraflox was compared with antibiotics that are commonly used for the treatment of the infections studied (amoxicillin with or without clavulanic acid for the skin and urinary tract infections, and clindamycin for the gum infections).
Danish: I alle undersøgelserne blev virkningen af Veraflox sammenlignet med antibiotika, der er almindeligt brugt til behandling af de undersøgte infektioner (amoxicillin med eller uden clavulansyre for hud- og urinvejsinfektioner og clindamycin for gummeinfektioner).
English: The 60 mg and 120 mg tablets are only for use for dogs, and Veraflox oral suspension is only for use in cats.
Danish: 60-mg-tabletterne og 120-mgtabletterne må kun anvendes til hunde, og Veraflox oral suspension må kun anvendes til katte.
English: If Veraflox is swallowed accidentally, seek medical advice immediately and show the package leaflet or the label to the doctor.
Danish: Hvis en person utilsigtet kommer til at sluge Veraflox, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal medbringes og vises til lægen.
English: Veraflox products can be harmful to children if they are accidentally swallowed.
Danish: Veraflox-lægemidler kan være skadelige for børn, hvis lægemidlerne ved et uheld sluges.
English: People should ensure that Veraflox does not come into contact with their skin or eyes.
Danish: Veraflox må ikke komme i kontakt med hud eller øjne.
English: People who are hypersensitive (allergic) to quinolone antibiotics should avoid any contact with Veraflox.
Danish: Personer, som er overfølsomme (allergiske) over for quinoloner, bør undgå kontakt med Veraflox.
English: Veraflox must not be used in young growing dogs, in kittens below 6 weeks of age, in animals with joint problems caused by damage to the cartilage, or in animals with central nervous system disorders such as epilepsy.
Danish: Veraflox må ikke anvendes til unge hunde i vækstperioden, til killinger under 6-ugers-alderen, til dyr med skader i ledbrusken eller til dyr med sygdomme i centralnervesystemet, såsom epilepsi.
English: Why has Veraflox been approved?
Danish: Hvorfor blev Veraflox godkendt?
English: The standard dose for tablets is 3 mg pradofloxacin per kilogram body weight once a day.
Danish: Standarddosis for tabletter er 3 mg pradofloxacin pr. kilo legemsvægt én gang dagligt.
English: Veraflox must not be used in animals that may be hypersensitive (allergic) to fluoroquinolone antibiotics.
Danish: Veraflox må ikke anvendes til dyr, som kan være overfølsomme (allergiske) over for fluoroquinoloner.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Veraflox exceed the risks for the treatment of certain specified infections in dogs and cats and recommended that Veraflox be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Veraflox opvejer risiciene ved behandling af visse nærmere bestemte indikationer hos hunde og katte, og anbefalede udstedelse af markedsføringstilladelse for Veraflox.
English: The company presented the results of studies looking at the effectiveness of Veraflox against a range of bacterial infections in cats and dogs.
Danish: Virksomheden forelagde resultaterne af undersøgelser af virkningen af Veraflox mod en række bakterieinfektioner hos katte og hunde.
English: What is the risk associated with Veraflox?
Danish: Hvilken risiko er der forbundet med Veraflox?
English: More information on the benefit-risk balance can be found in the Scientific Discussion part of this EPAR.
Danish: Der kan findes yderligere oplysninger om risk-benefit-forholdet for Veraflox i den faglige drøftelse, der er en del af denne EPAR.
English: Therefore all products should be kept out of the reach and sight of children.
Danish: Derfor skal alle lægemidler opbevares utilgængeligt for børn.
English: The most common side effects in dogs and cats are mild transient gastro-intestinal disturbances including vomiting, although these have only been observed rarely.
Danish: De hyppigste bivirkninger hos hunde og katte er milde forbigående gastrointestinale forstyrrelser, inklusiv opkastning, men disse er kun set i sjældne tilfælde.
English: How has Veraflox been studied?
Danish: Hvordan blev Veraflox undersøgt?
English: For the oral suspension it is 5 mg pradofloxacin per kilogram body weight once a day.
Danish: Standarddosis for oral suspension er 5 mg pradofloxacin pr. kilo legemsvægt én gang daglig.
English: Veraflox must not be used in female animals that are pregnant or lactating.
Danish: Veraflox må ikke anvendes til drægtige eller diegivende dyr.
English: The full list of bacteria against which Veraflox is active can be found in the Summary of Product Characteristics (SPC).
Danish: Den fuldstændige liste over de bakteriearter, som Veraflox virker mod, findes i produktresuméet.
English: In addition, the oral suspension can also be used to treat some skin infections, including wound infections and abscesses, caused by certain specific bacteria.
Danish: Endvidere kan den orale suspension anvendes til behandling af visse hudinfektioner, herunder sårinfektioner og abscesser (bylder), forårsaget af nogle bestemte bakterier.
English: For more information see the package leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: Veraflox is well tolerated in cats and dogs with mild transient gastro-intestinal disturbances, including vomiting, being observed only in rare cases.
Danish: Veraflox er veltolereret hos katte og hunde, og der er kun i sjældne tilfælde set milde forbigående gastrointestinale forstyrrelser, inklusiv opkastning.
English: What is Veraflox used for?
Danish: Hvad anvendes Veraflox til?
English: In dogs, Veraflox is used to treat some skin infections, including wound infections, and acute urinary tract infections caused by certain specific bacteria.
Danish: Hos hunde anvendes Veraflox til behandling af visse hudinfektioner, herunder sårinfektioner, og akutte infektioner i urinvejene forårsaget af nogle bestemte bakterier.
English: What benefit has Veraflox shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Veraflox?
English: In cats, Veraflox is used to treat acute infections of the upper respiratory tract caused by certain specific bacteria.
Danish: Hos katte anvendes Veraflox til behandling af akutte infektioner i de øvre luftveje forårsaget af nogle bestemte bakterier.
English: In dogs, the medicine was studied in some skin, urinary tract and gum infections caused by certain specific bacteria.
Danish: For hunde blev der foretaget undersøgelser af lægemidlets virkning ved visse hud-, urinvejs- og gummeinfektioner forårsaget af nogle bestemte bakterier.
English: In cats, the medicine was studied in acute infections of the upper respiratory tract and also some skin infections caused by certain specific bacteria.
Danish: Hos katte blev der foretaget undersøgelser af lægemidlets virkning ved akutte infektioner i de øvre luftveje og ved visse hudinfektioner forårsaget af nogle bestemte bakterier.
English: How does Veraflox work?
Danish: Hvordan virker Veraflox?
English: This summary was last updated in 09- 2011.
Danish: Dette sammendrag blev sidst ajourført i 09-2011.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 11 July 2002.
Danish: Efter at virksomheden havde fremlagt de supplerende oplysninger, den var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 11. juli 2002.
English: Similar results were seen in HIV-1-infected children.
Danish: Der blev observeret lignende resultater hos hiv-1-smittede børn.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viramune on 5 February 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Viramune den 5. februar 1998.
English: The full EPAR for Viramune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Viramune findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Viramune was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of the approval.
Danish: Viramune blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet af videnskabelige årsager kun forelå begrænsede oplysninger.
English: Viramune is never taken on its own.
Danish: Viramune skal aldrig tages alene.
English: The prolonged-release tablets have not been tested in children under 3 years of age.
Danish: Depottabletterne er ikke blevet testet på børn under 3 år.
English: It must be taken with at least two other antiviral medicines.
Danish: Det skal tages sammen med mindst to andre antivirale lægemidler.
English: Viramune immediate-release has been studied in five studies involving a total of 1,956 adults.
Danish: Viramune tabletter med umiddelbar frigivelse blev undersøgt i fem undersøgelser, der omfattede i alt 1.956 voksne.
English: This is a summary of the European public assessment report (EPAR) for Viramune.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Viramune.
English: Because the medicine can cause serious rash, treatment should be started at low doses.
Danish: Da lægemidlet kan fremkalde alvorligt udslæt, skal behandlingen indledes med lave doser.
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 Viramune.
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 Viramune.
English: Patients should be monitored closely for signs of these side effects during the first 18 weeks of treatment, and blood tests for liver problems should be carried out regularly throughout treatment.
Danish: Patienterne skal observeres nøje for tegn på disse bivirkninger i løbet af de første 18 uger af behandlingen, og i hele behandlingsforløbet skal der regelmæssigt tages blodprøver for at teste for leverproblemer.
English: Viramune does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Viramune kurerer ikke hiv-1-infektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og udviklingen af infektioner og sygdomme, der er forbundet med aids.
English: For more information about treatment with Viramune, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Viramune, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: EPAR summary for the public nevirapine
Danish: EPAR - sammendrag for offentligheden nevirapin
English: Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours which allows it to be given less frequently.
Danish: Tabletter med umiddelbar frigivelse frigiver straks det aktive stof, og depottabletter frigiver det langsomt i løbet af nogle timer, hvilket gør, det ikke skal gives lige så tit.
English: Treatment with Viramune should be given by a doctor who has experience in the treatment of HIV infection.
Danish: Behandling med Viramune skal administreres af en læge med erfaring i behandling af hivinfektion.
English: CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV.
Danish: CD4 T-celler er hvide blodceller, som er vigtige, for at kroppen kan bekæmpe infektioner, men som dræbes af hiv.
English: Viramune, taken alone or in combination with one or two other antiviral medicines, has also been studied in two studies including 478 children.
Danish: Viramune, taget alene eller i kombination med et eller to andre antivirale lægemidler, blev også undersøgt i to undersøgelser, der omfattede 478 børn.
English: Viramune is an antiviral medicine.
Danish: Viramune er et antiviralt lægemiddel.
English: Other information about Viramune
Danish: Andre oplysninger om Viramune:
English: The dose should not be increased to the maintenance dose until any rash has cleared.
Danish: Dosis må ikke øges til vedligeholdelsesdosis, før eventuelt udslæt er forsvundet.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to infect cells in the body and make more viruses.
Danish: Det blokerer aktiviteten af revers transkriptase, et enzym, som produceres af hiv-1, og som gør det muligt for det at inficere celler i kroppen og producere mere virus.
English: It is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes i kombination med andre antivirale lægemidler til behandling af patienter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er en virus, der forårsager erhvervet immundefekt syndrom (aids).
English: The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Det aktive stof i Viramune, nevirapin, er en non-nukleosid revers transkriptasehæmmer (NNRTI).
English: Viramune, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines.
Danish: Viramune, taget i kombination med to andre antivirale lægemidler, var mere effektivt end kombinationer med to lægemidler.
English: The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in HIV-infected patients.
Danish: De yderligere undersøgelser viste, at depottabletterne var lige så effektive som tabletterne med umiddelbar frigivelse hos hivsmittede patienter.
English: The prolonged-release tablets must not be broken or chewed.
Danish: Depottabletterne må ikke knuses eller tygges.
English: The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and in the number of CD4 T-cells in the blood (CD4 cell count), and the number of patients whose disease got worse or who died.
Danish: De primære effektmål var ændringen i koncentrationen af hiv i blodet (viral belastning) og i antallet af CD4 T-celler i blodet (CD4-celletal) samt antallet af patienter, hvis sygdom blev forværret, eller som døde.
English: Treatment with Viramune must not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who had signs of liver problems while they were taking Viramune that returned when the medicine was started again.
Danish: Behandling med Viramune må ikke startes igen hos patienter, som tidligere har været nødsaget til at afbryde behandling med dette lægemiddel på grund af udslæt, allergiske reaktioner eller hepatitis, eller som har haft tegn på leverproblemer, mens de tog Viramune, som vendte tilbage, da behandling med dette lægemiddel blev genoptaget.
English: Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or of dying.
Danish: Voksne, som fik behandling med tre lægemidler, havde også større stigninger i CD4-celletal og en lavere risiko for sygdomsforværring eller død.
English: For children and adolescents, the starting dose is 150 mg per square metre of body surface area (calculated using the child's height and weight) or 4 mg/kg once a day for two weeks with Viramune oral suspension, after which the dose should be increased to a maintenance dose (calculated using the patient's body surface area or weight).
Danish: For børn og voksne er startdosis 150 mg pr. kvadratmeter kropsoverflade (beregnet ved hjælp af barnets højde og vægt) eller 4 mg/kg én gang dagligt i to uger med Viramune oral suspension, hvorefter dosis bør øges til en vedligeholdelsesdosis (beregnet ved hjælp af patientens kropsoverflade eller vægt).
English: By blocking this enzyme, Viramune, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym reducerer Viramune, når det tages i kombination med andre antivirale lægemidler, koncentrationen af hiv-1 i blodet og holder den på et lavt niveau.
English: In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral load fell by 99% in the three-medicine group, compared with 96% in the two-medicine group after 40 to 52 weeks.
Danish: Hos 151 behandlingsnaive patienter (som ikke tidligere havde fået behandling mod hivinfektion) faldt virusbelastningen efter 40 til 52 uger med 99 % i gruppen, som fik behandling med tre lægemidler, sammenlignet med 96 % i den gruppe, som fik behandling med to lægemidler.
English: Viramune must not be used in people who are hypersensitive (allergic) to nevirapine or any of the other ingredients.
Danish: Viramune må ikke anvendes til personer, som er overfølsomme (allergiske) over for nevirapin eller et eller flere af de øvrige indholdsstoffer.
English: It is available as immediaterelease (200 mg) and prolonged-release tablets (50, 100 and 400 mg) and as an oral suspension (50 mg/5 ml).
Danish: Det fås som tabletter med umiddelbar frigivelse (200 mg), som depottabletter (50, 100 and 400 mg) og som oral suspension (50 mg/5 ml).
English: Viramune is a medicine that contains the active substance nevirapine.
Danish: Viramune er et lægemiddel, der indeholder det aktive stof nevirapin.
English: The most common side effects with Viramune (seen in between 1 and 10 patients in 100) are rash, headache, nausea (feeling sick), fatigue, abdominal pain, diarrhoea, fever, hepatitis (inflammation of the liver) and signs of liver problems in the blood.
Danish: De mest almindelige bivirkninger ved Viramune (som optræder hos mellem 1 og 10 ud af 100 patienter) er udslæt, hovedpine, kvalme, træthed, mavesmerter, diarré, feber, hepatitis (leverbetændelse) og tegn på leverproblemer i blodet.
English: The Committee recommended that Viramune be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Viramune.
English: Viramune has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions.
Danish: Viramune har også været forbundet med alvorlige bivirkninger, herunder Stevens-Johnson syndrom og toksisk epidermal nekrolyse (livstruende allergiske hud- og slimhindereaktioner), alvorlig hepatitis og leversvigt samt alvorlige allergiske reaktioner.
English: If the patient cannot switch to the full dose within four weeks of starting Viramune, alternative treatments should be sought.
Danish: Hvis patienten ikke kan skifte til den fulde dosis senest fire uger efter, at behandlingen med Viramune er indledt, skal der findes en anden behandling.
English: For adults, treatment should start with 200 mg immediate-release tablets or oral suspension once a day for two weeks.
Danish: Behandlingen af voksne bør starte med 200 mg tabletter med umiddelbar frigivelse eller oral suspension én gang dagligt i to uger.
English: The prolonged-released tablets are not suitable for the initial two week phase for patients starting on Viramune and should not be used until any rash has cleared.
Danish: Depottabletter er ikke egnet til de første to uger for patienter, der starter med Viramune, og må ikke anvendes, før eventuelt udslæt er forsvundet.
English: In 398 treatment-experienced adults (who had taken treatment for HIV infection before), Viramune in combination with zidovudine and lamivudine led to a 38% reduction in viral load after 48 weeks, compared with a 28% rise in those taking zidovudine and lamivudine without Viramune.
Danish: Hos 398 voksne behandlingserfarne patienter (som tidligere havde fået behandling mod hivinfektion) førte behandling med Viramune i kombination med zidovudin og lamivudin til en 38 %-reduktion i virusbelastningen efter 48 uger sammenlignet med en 28 %-stigning hos de patienter, som fik behandling med zidovudin og lamivudin uden Viramune.
English: What is the risk associated with Viramune?
Danish: Hvilken risiko er der forbundet med Viramune?
English: The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine) and that there was insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after Viramune treatment.
Danish: Udvalget konstaterede, at størstedelen af de tilgængelige erfaringer med Viramune har været i kombination med nukleoside revers transkriptasehæmmere (NRTI'er, en type antiviralt lægemiddel), og at der ikke forelå tilstrækkelige videnskabelige data om brugen af kombinationsbehandling, heriblandt en proteasehæmmer (en anden type antiviralt lægemiddel), efter behandling med Viramune.
English: It must not be used in patients who have severe problems with their liver or signs of liver problems in the blood, or who are taking St John's wort (a herbal preparation used to treat depression).
Danish: Det må ikke anvendes til patienter, som har alvorlige leverproblemer eller tegn på leverproblemer i blodet, eller som tager perikum (en urtemedicin til behandling af depression).