FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.2 Posology and method of administration The Committee harmonised the doses of Valtrex to be used for the different conditions.
Danish: 4.2 Dosering og indgivelsesmåde Udvalget harmoniserede de doser af Valtrex, som anvendes til forskellige tilstande.
English: It should also be used with caution during breast-feeding.
Danish: Det bør også anvendes med forsigtighed af ammende kvinder.
English: The CHMP recommended that Valtrex should not be used in people who may be hypersensitive (allergic) to valaciclovir, aciclovir or to any of the excipients.
Danish: CHMP anbefalede, at Valtrex ikke bør anvendes hos personer, der kan være overfølsomme (allergiske) over for valaciclovir, aciclovir eller andre af hjælpestofferne.
English: Valtrex is an antiviral medicine that contains the active substance valaciclovir.
Danish: Valtrex er et antiviralt lægemiddel, der indeholder det aktive stof valaciclovir.
English: 1,000 mg twice a day for at least five days for treating immunocompromised patients.
Danish: 1 000 mg to gange dagligt i mindst fem dage til behandling af immunkompromitterede patienter.
English: 500 mg once a day for suppressing the recurrence of HSV infections in immunocompetent adults and 500 mg twice daily in immunocompromised adults.
Danish: 500 mg én gang dagligt til suppression af recidiverende HSV-infektioner hos immunkompetente voksne og 500 mg to gange dagligt hos immunkompromitterede voksne.
English: • For the prevention of cytomegalovirus infection following organ transplantation in adults and adolescents, the recommended dosage is 2000 mg four times a day, to be started as early as possible after the transplant.
Danish: • Til forebyggelse af cytomegalovirusinfektion efter organtransplantation hos voksne og unge er den anbefalede dosis 2 000 mg fire gange dagligt og påbegyndes så tidligt som muligt efter transplantationen.
English: • HSV infections of the skin and mucous membranes including: the treatment of the first episode of genital herpes in immunocompetent patients; the treatment of recurrent episodes of genital herpes in immunocompetent and immunocompromised patients (patients with a weakened immune system); the suppression of the recurrence of genital herpes in immunocompetent and immunocompromised patients; treatment of herpes labialis (cold sores); the treatment and suppression of recurrent ocular (eye) HSV infection;
Danish: • behandling og suppression af HSV-infektioner i hud og slimhinder, herunder: behandling af primær infektion af genital herpes hos immunkompetente patienter behandling af recidiverende genital herpes hos immunkompetente og immunkompromitterede patienter (patienter med svækket immunsystem) suppression af recidiverende genital herpes hos immunkompetente og immunkompromitterede patienter behandling af herpes labialis (forkølelsessår) behandling og suppression af recidiverende HSV-øjeninfektion
English: • For the treatment of herpes zoster, the recommended dose is 1000 mg three times a day for seven days in immunocompetent adults.
Danish: • Til behandling af herpes zoster er den anbefalede dosis 1 000 mg tre gange dagligt i syv dage hos immunkompetente voksne.
English: • the treatment of herpes zoster in adults with mild or moderate immunosuppression (reduced activity of the immune system);
Danish: • behandling af herpes zoster hos voksne med mild til moderat immunsuppression (patienter med reduceret aktivitet i immunsystemet)
English: • the treatment of herpes zoster (shingles) and ophthalmic zoster (shingles around the eye) in immunocompetent adults (patients with an immune system that works normally);
Danish: • behandling af herpes zoster (helvedesild) og zoster ophthalmicus (helvedesild omkring øjnene) hos immunkompetente voksne (patienter med et normalt fungerende immunsystem)
English: • For use in HSV infections of the skin and mucous membranes, the following doses are recommended: 500 mg twice a day for treating immunocompetent patients.
Danish: • Til anvendelse ved HSV-infektioner i hud og slimhinder anbefales følgende doser: 500 mg to gange dagligt til behandling af immunkompetente patienter.
English: Valtrex was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af koordinationsgruppen for gensidig anerkendelse og decentrale procedurerhumanmedicinske lægemidler (CMD(h)), at Valtrex skulle harmoniseres.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zactran on 24 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zactran den 24. juli 2008.
English: The full EPAR for Zactran can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zactran findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Zactran
Danish: Andre oplysninger om Zactran
English: The cattle may also show signs of slight pain at the site of injection for one day.
Danish: Kvæg kan desuden vise tegn på let smerte på injektionsstedet i en dag.
English: This is a summary of the European public assessment report (EPAR) for Zactran.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zactran.
English: It is not intended to provide practical advice on how to use Zactran.
Danish: Det er ikke en praktisk vejledning i, hvordan Zactran bør anvendes.
English: Why is Zactran approved?
Danish: Hvorfor blev Zactran godkendt?
English: What is Zactran and what is it used for?
Danish: Hvad er Zactran, og hvad anvendes det til?
English: These local reactions are short-lived and typically resolve within 2 days for pigs and 4 days for sheep.
Danish: Disse lokale reaktioner er kortvarige og fortager sig sædvanligvis inden for to dage for svin og fire dage for får.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zactran's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Zactran opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The main measures of effectiveness were respiratory and depression scores as well as body temperature.
Danish: De vigtigste mål for virkningen var scoreværdierne for vejrtrækning og depression samt kropstemperaturen.
English: The withdrawal period is 64 days for meat from cattle, 16 days for meat from pigs and 29 days for meat from sheep treated with Zactran.
Danish: Tilbageholdelsestiden er 64 dage for kød fra kvæg, 16 dage for kød fra svin og 29 dage for kød fra får, der er behandlet med Zactran.
English: As Zactran is an antibiotic, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Danish: Da Zactran er et antibiotikum, er det vigtigt at følge anvisningerne i indlægssedlen nøje for at minimere risikoen for antibiotikaresistens.
English: Cattle weighing more than 250 kg, and pigs and sheep weighing more than 125 kg, will need to have the dose divided and injected at more than one site.
Danish: For kvæg på over 250 kg og svin og får på over 125 kg må dosis opdeles, så den injiceres på flere steder.
English: What are the risks associated with Zactran?
Danish: Hvilke risici er der forbundet med Zactran?
English: It should also not be used within 2 months of calving in pregnant cows and heifers intended to produce milk for human consumption or within 1 month of lambing in pregnant ewes intended to produce milk for human consumption.
Danish: Det bør heller ikke anvendes de sidste to måneder før kælvning hos drægtige køer og kvier, som skal producere mælk til menneskeligt konsum, eller den sidste måned før læmning hos drægtige får, som skal producere mælk til menneskeligt konsum.
English: Zactran is given as a single dose, by injection under the skin for cattle and sheep and into muscle for pigs.
Danish: Zactran gives som en enkeltdosis ved injektion under huden hos kvæg og får, og i en muskel hos svin.
English: It works by blocking the bacteria's ribosomes, which are parts of the cells where proteins are produced, and so prevents the bacteria from growing.
Danish: Det virker ved at blokere bakteriernes ribosomer, som er dele af cellerne, der producerer proteiner.
English: The medicine is not authorised for use in animals producing milk for human consumption.
Danish: Lægemidlet må ikke anvendes til dyr, som producerer mælk til menneskeligt konsum.
English: As the efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions or inappropriate farm management, treatment of foot rot should therefore be undertaken along with other flock management tools.
Danish: Da virkningen af antimikrobiel behandling af klovspalteforrådnelse kan svækkes af andre faktorer som f.eks. våde omgivelser eller uhensigtsmæssig forvaltning af landbrugsbedriften, bør behandlingen af klovspalteforrådnelse gennemføres sammen med andre flokstyringsredskaber.
English: Zactran must not be given to animals hypersensitive (allergic) to any macrolide, and must not be used at the same time as other macrolides or another type of antibiotic called lincosamides.
Danish: Zactran må ikke gives til dyr, som er overfølsomme (allergiske) overfor noget makrolid, og må ikke anvendes samtidig med andre makrolider eller en anden type antibiotika kaldet linkosamider.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label should be presented to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: • foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum needing systemic treatment (treatment reaching the bacteria via the blood stream, e.g. by injection).
Danish: • klovspalteforrådnelse hos får, der er forårsaget af Dichelobacter nodosus og Fusobacterium necrophorum, og som kræver systemisk behandling (hvor behandlingen når bakterierne via blodbanen, f.eks. ved injektion).
English: Zactran contains the active substance gamithromycin.
Danish: Zactran indeholder det aktive stof gamithromycin.
English: People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran.
Danish: Personer, som er hypersensitive (allergiske) over for lignende antibiotika (makrolidgruppen), bør undgå kontakt med Zactran.
English: Treatment success was 97% in the Zactran-treated pigs compared to 93% in the tildipirosin group.
Danish: Behandlingens succesrate var 97 % hos de svin, der blev behandlet med Zactran, sammenholdt med 93 % hos gruppen på tildipirosin.
English: The swelling generally resolves in 3 to 14 days but may persist in some cattle for up to
Danish: Hævelsen fortager sig sædvanligvis efter 3-14 dage, men kan hos nogle kreaturer vare ved i op til 35 dage efter behandlingen.
English: In a study involving 364 sheep with typical signs of foot rot, 98% of Zactran-treated sheep were successfully treated after 3 weeks compared to 93% of tilmicosin-treated sheep based on lameness scores.
Danish: I en undersøgelse hos 364 får med typiske tegn på klovspalteforrådnelse blev 98 % af de får, der blev behandlet med Zactran, helbredt efter 3 uger sammenlignet med 93 % af de får, der fik tilmicosin, baseret på scoreværdierne for lammelse.
English: Zactran was as effective as tilmicosin in treating severe foot rot in sheep.
Danish: Zactran var ligeså effektivt som tilmicosin til behandling af svær klovspalteforrådnelse hos får.
English: When treating foot rot in sheep, appropriate flock management measures should be used, such as keeping sheep in a dry environment.
Danish: Ved behandling af klovspalteforrådnelse hos får skal der træffes passende foranstaltninger til at sikre, at flokken holdes i tørre omgivelser.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zactran, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zactran, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: The active substance of Zactran, gamithromycin, is an antibiotic of the macrolide group.
Danish: Det aktive stof i Zactran, gamithromycin, er et antibiotikum i makrolidgruppen.
English: Zactran may cause irritation to the eyes or the skin.
Danish: Zactran kan forårsage øjen- og hudirritation.
English: For the metaphylaxis of BRD, the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely also to develop the disease.
Danish: Virkningen af Zactran til metafylaktisk behandling af luftvejssygdom hos kvæg blev sammenlignet med virkningsløs behandling (placebo) hos kvæg, som havde været i kontakt med syge dyr på samme landbrugsbedrift, og som derfor også måtte forventes at udvikle sygdommen.
English: Zactran can also be used metaphylactically, which means to treat at the same time both diseased cattle and healthy cattle in close contact with them, in order to prevent healthy animals from developing infection and so prevent further spread of the disease.
Danish: Det betyder, at man på samme tid behandler både syge kreaturer og raske kreaturer, som er i tæt kontakt med de syge, for at forhindre de raske dyr i at udvikle symptomer og således forhindre, at sygdommen spredes yderligere.
English: • swine respiratory disease (SRD), a lung infection in pigs, caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica;
Danish: • luftvejsinfektion hos svin (SRD), der er en lungeinfektion forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis og Bordetella bronchiseptica
English: The most common side effects with Zactran in pigs and sheep (which may affect up to 1 in 10 animals) are mild to moderate swellings at the site of injection.
Danish: Hos svin og får er den hyppigste bivirkning ved Zactran (som kan optræde hos op til 1 ud af 10 dyr) let til moderat hævelse på injektionsstedet.
English: Similarly, if Zactran comes into direct contact with skin, the affected area should be washed immediately with clean water.
Danish: I tilfælde af direkte hudkontakt skal det berørte område ligeledes omgående skylles med rent vand.
English: The most common side effects with Zactran in cattle (which may affect more than 1 in 10 cattle) are swellings at the site of injection.
Danish: Hos kvæg er den hyppigste bivirkning ved Zactran (som kan optræde hos op til 1 ud af 10 kreaturer) hævelse på injektionsstedet.
English: Therefore, contact with skin or eyes should be avoided.
Danish: Undgå derfor, at Zactran kommer i kontakt med hud eller øjne.
English: For the full list of all side effects reported with Zactran, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zactran fremgår af indlægssedlen.
English: A second field study in pigs with SRD compared Zactran to tulathromycin, however, in this study Zactran was not as effective as tulathromycin.
Danish: I endnu en feltundersøgelse hos svin med luftvejssygdom blev Zactran sammenlignet med tulathromycin, men i denne undersøgelse var Zactran ikke så effektivt som tulathromycin.
English: If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water.
Danish: I tilfælde af direkte øjenkontakt skal øjnene omgående skylles med rent vand.
English: Zactran was shown to be effective in the treatment and metaphylaxis of BRD associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Zactran viste sig effektivt til behandling og metafylaktisk behandling af luftvejssygdom hos kvæg, som var forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: What benefits of Zactran have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zactran?
English: For the treatment of BRD, Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) in cattle already affected by the disease.
Danish: I undersøgelserne blev Zactran til behandling af luftvejssygdom hos kvæg sammenlignet med et andet makrolidantibiotikum (tulathromycin) hos kvæg, der allerede havde sygdommen.
English: How does Zactran work?
Danish: Hvordan virker Zactran?
English: When using Zactran for metaphylaxis of BRD, the presence of the disease in the herd should be established first;
Danish: Før Zactran anvendes til metafylaktisk behandling af luftvejssygdom hos kvæg, skal det være fastslået, at sygdommen er til stede i besætningen
English: In the treatment of BRD, Zactran was shown to be as effective as tulathromycin.
Danish: Til behandling af luftvejssygdom hos kvæg viste Zactran sig at være lige så effektivt som tulathromycin.
English: How is Zactran used?
Danish: Hvordan anvendes Zactran?
English: • bovine respiratory disease (BRD), a lung infection in cattle, caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: • luftvejsinfektion hos kvæg (BRD), der er en lungeinfektion forårsaget af bakterierne Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: For the treatment of SRD, a field study was conducted in pigs with SRD comparing Zactran to tildipirosin, another macrolide antibiotic.
Danish: Der blev udført en feltundersøgelse hos svin med luftvejssygdom, hvor Zactran blev sammenlignet med et andet makrolidantibiotikum, tildipirosin.
English: For more information about treatment with Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Zactran, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Zactran, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Zactran, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Zactran is a type of antibiotic called a macrolide that is used to treat the following bacterial infections:
Danish: Det anvendes til behandling af følgende bakterieinfektioner:
English: E-mail info@ema.europa.eu Website www.ema.europa.eu
Danish: E-mail nfo@ema.europa.eu Website www.ema.europa.eu
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Activyl to Intervet International BV on 18/02/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Activyl til Intervet International BV den 18/02/2011.
English: Other information about Activyl:
Danish: Andre oplysninger om Activyl:
English: Activyl should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Danish: Activyl må ikke hældes ud i overfladevand, da det kan være skadeligt for vandorganismer.
English: This means that it will kill parasites that live on the skin or in the fur of animals, such as fleas.
Danish: Det betyder, at det dræber parasitter, der lever på dyrs hud eller i dyrs pels, som f.eks. lopper.
English: This active compound interferes with the parasites' nervous system and causes paralysis and death.
Danish: Det aktive stof påvirker parasitternes nervesystem og forårsager lammelse og død.
English: Dogs and cats might salivate after treatment.
Danish: Hos katte og hunde kan der forekomme savlen efter behandlingen.
English: What is the risk associated with Activyl?
Danish: Hvilken risiko er der forbundet med Activyl?
English: The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of flea infestations in dogs and cats.
Danish: CVMP konkludere, at fordelene ved Activyl er større end risiciene ved behandling og forebyggelse af loppeangreb hos hunde og katte.
English: Activyl is given as a single treatment.
Danish: Activyl gives som en enkeltdosisbehandling.
English: Furthermore, the CVMP concluded that the product is effective as part of a treatment strategy for flea allergy dermatitis and recommended that Activyl be given a marketing authorisation.
Danish: CVMP konkluderede desuden, at produktet er effektivt som led i en behandlingsstrategi mod loppeforårsaget dermatitis, og anbefalede udstedelse af markedsføringstilladelse for Activyl.
English: In the main field study, dogs and cats of various breeds, age groups, gender and different weights were treated either with Activyl or fipronil, another spot-on medicine which is authorised in the European Union for this indication.
Danish: I hovedfeltundersøgelsen blev hunde og katte af forskellige racer, aldersgrupper, køn og vægtklasser enten behandlet med Activyl eller fipronil, et andet spot-onlægemiddel, som er godkendt til denne indikation i Den Europæiske Union.
English: Activyl is a medicine that contains the active substance indoxacarb.
Danish: Activyl er et lægemiddel, der indeholder det aktive stof indoxacarb.
English: If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.
Danish: Ved utilsigtet kontakt med hud eller øjne skal øjnene skylles med vand, og huden vaskes med vand og sæbe.
English: Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment.
Danish: Der blev forelagt oplysninger om den farmaceutiske kvalitet, om hvordan produktet tåles af katte og hunde, om sikkerheden for mennesker ved kontakt med produktet og om sikkerheden for miljøet.
English: The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Activyl is as effective as the comparator medicine.
Danish: Resultaterne af laboratorieundersøgelserne og feltundersøgelserne hos både katte og hunde viste, at Activyl er lige så effektivt som sammenligningspræparatet.
English: The product should be kept away from heat, sparks, open flames or other sources of ignition.
Danish: Produktet må ikke komme i kontakt med varmekilder, gnister, åben ild eller antændelseskilder.
English: The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat's neck at the base of its head, or between the shoulder blades and along the back of dogs.
Danish: Indholdet af én fuld Activyl-pipette (passende til dyret og dets vægt) påføres direkte på huden, efter at pelsen er delt, i kattens nakke ved den nedre del af kraniet eller mellem skulderbladene og langs ryggen hos hunde.
English: Care should be taken to ensure that the content of the pipette should not come into contact with the eyes of the recipient or other animals.
Danish: Man skal sikre sig, at pipettens indhold ikke kommer i kontakt med øjne, hverken dyrets egne eller andre dyrs.
English: Why has Activyl been approved?
Danish: Hvorfor blev Activyl godkendt?
English: Pet owners should avoid skin contact with the pipette contents.
Danish: Kæledyrsejere bør undgå hudkontakt med pipettens indhold.
English: Efficacy against flea infestations of more than 95% was achieved in dogs by 14 days post treatment and in cats by 42 days post treatment in the study.
Danish: I undersøgelsen opnåede man en virkning mod loppeangreb på over 95 % 14 dage efter behandlingen hos hunde og 42 dage efter behandlingen hos katte.