FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Evicto, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Evicto, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evicto, 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 Evicto, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: How has Evicto been studied?
Danish: Hvordan er Evicto blevet undersøgt?
English: Evicto is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worms that live inside the body.
Danish: Evicto er et lægemiddel mod parasitter, der anvendes til behandling og forebyggelse af angreb fra parasitter, der lever på huden eller i pelsen på katte og hunde, såsom lopper og mider, samt til behandling af orm, der lever i kroppen.
English: How is Evicto used?
Danish: Hvordan anvendes Evicto?
English: The contents of the tube are squeezed onto the skin after parting the fur at the base of the neck between the shoulder blades.
Danish: Pelsen i den nederste del af nakken skilles mellem skulderbladene, og tubens indhold presses ud på huden.
English: It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Danish: til behandling og forebyggelse af loppeangreb hos katte og hunde ved at dræbe voksne lopper, deres larver og deres æg på dyret og i kuldene hos drægtige eller diegivende katte eller hunde.
English: How does Evicto work?
Danish: Hvordan virker Evicto?
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Danish: til forebyggelse af hjerteorm hos katte og hunde til behandling af øremider hos katte og hunde til behandling af voksne spolorme og hageorme i tarmene hos katte til behandling af voksne spolorme i tarmene hos hunde til behandling af angreb med bidende lus hos katte og hunde til behandling af sarcoptesskab hos hunde.
English: Their frequency is unknown.
Danish: Hyppigheden heraf er ukendt.
English: 20 October 2015
Danish: Den 20. oktober 2015
English: or hybrids of both species.
Danish: eller hybrider af begge arter.
English: Moreover, the intended use does not require medical supervision.
Danish: Desuden kræver den tilsigtede anvendelse ikke lægeligt tilsyn.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom healthcare practitioner should be consulted.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Betula pendula Roth and/or Betula pubescens Ehrh., folium
Danish: Betula pendula Roth og/eller Betula pubescens Ehrh., folium
English: Although there are few clinical studies, including a study in 15 patients with urinary tract infections which suggested a positive effect on the urinary infection, data are too limited to be used as evidence.
Danish: Selvom nogle få kliniske undersøgelser, herunder en undersøgelse hos 15 patienter med urinvejsinfektioner, har tydet på en positiv virkning ved urinvejsinfektioner, er data endnu for begrænsede til at kunne anvendes som tilstrækkelig dokumentation.
English: Birch leaf
Danish: Birkeblad
English: They must also not be used in patient with conditions where a reduced fluid intake is recommended (such as severe heart or kidney disease).
Danish: De må heller ikke anvendes til patienter med tilstande, hvor der anbefales nedsat væskeindtag (såsom svær hjerte- eller nyresygdom).
English: Birch leaf is the common name for the leaves of the tree Betula pendula Roth and/or Betula pubescens Ehrh.
Danish: Birkeblad er fællesnavnet for bladene af træet Betula pendula Roth og/eller Betula pubescens Ehrh.
English: What is birch leaf?
Danish: Hvad er birkeblad?
English: Birch leaf medicines must not be used in patients who are hypersensitive (allergic) to birch leaf or birch pollen.
Danish: Lægemidler med birkeblad må ikke anvendes til patienter, der er overfølsomme (allergiske) over for birkeblad eller birkepollen.
English: Any applications for the licensing of medicines containing birch leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder birkeblad, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of birch leaf medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder birkeblad, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: If symptoms persist during treatment, a doctor or a qualified
Danish: Hvis symptomerne fortsætter under behandlingen, bør der søges råd hos en læge eller en anden kvalificeret sundhedsmedarbejder.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing birch leaf.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder birkeblad.
English: Further information on the HMPC assessment of birch leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder birkeblad, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with birch leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder birkeblad, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instruction on how to take birch leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler indeholdende birkeblad skal anvnedes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of birch leaf.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af birkeblad.
English: This summary is not intended to provide practical advice on how to use medicines containing birch leaf.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder birkeblad, anvendes.
English: Side effects that have been reported with birch leaf medicines include diarrhoea, feeling or being sick, and allergic reactions such as itching, rash and stuffy and runny nose.
Danish: Ved brug af lægemidler med birkeblad er beskrevet bivirkninger som diarré, kvalme, opkastning og allergiske reaktioner såsom kløe, udslæt og tilstoppet og løbende næse.
English: The leaves for medicinal use are obtained either from trees that have been cultivated or found in the wild.
Danish: Bladene til medicinsk anvendelse fås enten fra dyrkede eller vildtvoksende træer.
English: Birch leaf medicines should only be used in adults and adolescents above 12 years of age.
Danish: Lægemidler indeholdende birkeblad bør kun anvendes til voksne og børn over 12 år og anvendes saædvanligvis i et tidsrum på 2-4 uger.
English: Other information about birch leaf medicines
Danish: Andre oplysninger om lægemidler, der indeholder birkeblad
English: How are birch leaf medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder birkeblad, i EU?
English: What are the risks associated with birch leaf medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder birkeblad?
English: What evidence supports the use of birch leaf medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af birkeblad?
English: Hence, the HMPC conclusions on the use of birch leaf medicines are based on their long-standing use.
Danish: HMPC's konklusioner om brugen af lægemidler med birkeblad er derfor baseret på lægemidlernes "mangeårige anvendelse".
English: Birch leaf preparations are obtained by powdering or comminuting (reducing into tiny pieces) the dried leaf, or as dry or liquid extracts.
Danish: Tilberedninger af birkeblad fremstilles ved r findeling eller pulverisering af de tørrede blade eller som tørt eller flydende ekstrakt.
English: The HMPC conclusions on the use of birch leaf medicines to increase the production of urine are based on their ‘traditional use' in minor urinary tract problems.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler indeholdende birkeblad er baseret på den "traditionel anvendelse" til at øge urinproduktionen ved lettere urinvejsgener.
English: For more information about treatment with birch leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder birkeblad, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as water or alcohol).
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra matematerialet i vand eller alkohol.
English: Herbal medicines containing birch leaf preparations are usually available as herbal tea or in solid and liquid forms to be taken by mouth.
Danish: Plantelægemidler med birkeblad fås normalt som urtete eller i fast eller flydende form til indtagelse gennem munden.
English: For practical information about using birch leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med birkeblad, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For dry extracts the solvent is then evaporated to obtain the extract.
Danish: Ved fremstilling af tørekstrakter fordampes opløsningsmidlet herefterfor at opnå det tørre ekstrakt.
English: The HMPC concluded that, on the basis of its long-standing use, birch leaf medicines can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine, in order to achieve flushing of the urinary tract.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at lægemidler med birkeblad kan anvendes ved lettere urinvejsproblemer for at øge urinproduktionen og opnå en bedre gennemskylning af urinvejene.
English: These measures will help protect the environment.
Danish: Disse forholdsregler medvirker til at beskytte miljøet.
English: Children from birth to 23 months:
Danish: Børn fra fødsel til 23 måneder:
English: Take your next dose as scheduled.
Danish: Tag din næste dosis som planlagt.
English: Linearity / non-linearity
Danish: Linearitet/non-linearitet
English: This is a longterm treatment, possibly lasting for months or years.
Danish: Dette er en længerevarende behandling, der muligvis kan vare måneder eller år.
English: This age group may therefore require higher doses than are necessary in adults.
Danish: Denne aldersgruppe kan derfor behøve højere doser, end hvad der er nødvendigt hos voksne.
English: and/or Decreases <LLN
Danish: og/eller Faldende < LLN
English: and Once (1×)
Danish: og En gang (1×)
English: Frequency not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: If you miss a dose, take it as soon as you remember on that day.
Danish: Hvis du glemmer en dosis, så tag den, så snart du husker det den samme dag.
English: The educational programme is aimed to inform healthcare professionals and patients to minimise the risks of:
Danish: Uddannelsesprogrammet har til hensigt at informere sundhedspersonale og patienter for at minimere risici for:
English: Interaction with food
Danish: Interaktion med mad
English: In the clinical setting, this effect may be more pronounced.
Danish: I den kliniske virkelighed kan denne effekt være mere udtalt.
English: Additional tests may be required to monitor the blood levels of some of these medicines.
Danish: Supplerende undersøgelser kan være nødvendige for at kontrollere blodniveauet af nogle af disse lægemidler.
English: • Serum creatinine remains significantly elevated and
Danish: • Serum-kreatinin forbliver signifikant forhøjet og
English: 2900 Komarom HUNGARY
Danish: 2900 Komarom UNGARN
English: • Change in the colour of the skin
Danish: • Ændringer i farven på huden
English: The potential for toxicity to reproduction was assessed in rats and rabbits.
Danish: Potentialet for reproduktionstoksicitet blev vurderet hos rotter og kaniner.
English: Body weight, height and sexual development
Danish: Kropsvægt, højde og seksuel udvikling
English: The dosing recommendations for elderly patients are the same as described above.
Danish: Dosisrekommendationer for ældre patienter er de samme som beskrevet ovenfor.
English: No effect on the offspring was noted.
Danish: Der blev ikke set nogen effekt på afkommet.
English: No fertility data is available for humans.
Danish: Der er ingen fertilitetsdata tilgængelige for mennesker.
English: However, the initial dose should be the same as in adults, followed by individual titration.
Danish: Imidlertid bør startdosis være den samme som hos voksne, efterfulgt af individuel titrering.
English: These side effects are uncommon.
Danish: Disse bivirkninger er ikke almindelige.
English: Elderly patients (≥65 years of age)
Danish: Ældre patienter (≥ 65 år)
English: Your doctor will calculate the dose you need and tell you how many tablets to take each day.
Danish: Din læge vil beregne den dosis, der passer til dig, og fortælle dig hvor mange tabletter, du skal tage hver dag.
English: As the patient grows the doctor will adjust the dose.
Danish: Efterhånden som patienten vokser, vil lægen justere dosis.
English: However, this dosing recommendation was not prospectively assessed in the clinical studies.
Danish: Imidlertid blev denne dosisrekommendation ikke vurderet prospektivt i de kliniske studier.
English: These were dose-dependent.
Danish: Disse var dosisafhængige.
English: These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.
Danish: Disse stammer fra spontane rapporter, hvor det ikke altid er muligt at fastsætte en pålidelig frekvens eller årsagssammenhæng med eksponering af lægemidlet.
English: Since dosing is individually adjusted according to response this is not expected to have clinical consequences.
Danish: Da dosering er justeret individuelt i henhold til respons, forventes dette ikke at have kliniske konsekvenser.
English: • Abnormal level of acid in blood
Danish: • Unormalt niveau af syre i blodet
English: As needed.
Danish: Efter behov.
English: Not recommended
Danish: Anbefales ikke
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Danish: De fleste af bivirkningerne er milde til moderate og vil almindeligvis forsvinde efter et par dage til et par ugers behandling.
English: The mean elimination half-life (t½) ranged from 8 to 16 hours.
Danish: Den gennemsnitlige eliminationshalveringstid (t½) varierede fra 8 til 16 timer.
English: Vision and hearing
Danish: Syn og hørelse
English: • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
Danish: • Alt efter hvordan du reagerer på behandlingen, kan din læge senere justere din behandling til højere eller lavere dosis.
English: 6 months)
Danish: - 6. måned)
English: • Non-compliance of the posology and biological monitoring
Danish: • Ikke-compliance med dosering og biologisk monitorering
English: Older people (age 65 years and over)
Danish: Ældre (65 år og derover)
English: • If you experience partial loss of vision,
Danish: • Hvis du oplever delvist tab af dit syn,
English: Table 4 Summary of safety monitoring recommendations
Danish: Tabel 4 Opsummering af anbefalinger for sikkerhedsmonitorering
English: Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size.
Danish: Doser (i mg/kg) skal beregnes og afrundes til nærmeste hele tabletstørrelse.
English: Some side effects could be serious and need immediate medical attention.
Danish: Visse bivirkninger kan være alvorlige og kræve omgående lægehjælp.
English: Some side effects could become serious.
Danish: Visse bivirkninger kan blive alvorlige.
English: - if you have moderate or severe kidney disease.
Danish: - hvis du har en moderat eller alvorlig nyresygdom.
English: Safety monitoring schedules for renal and liver parameters are recommended.
Danish: Planer for sikkerhedsmonitorering for nyre- og leverparametre anbefales.
English: - if you are currently taking any other iron chelator medicines.
Danish: - hvis du for tiden indtager anden jernkelatormedicin.
English: Additional periodic distributions after launch should be performed, notably after substantial safety modifications of the product information justifying educational material updates.
Danish: Yderligere skal der periodisk efter lancering udleveres uddannelsesmateriale, specielt efter betydelige sikkerhedsrelaterede ændringer til produktinformationen, som retfærdiggør en opdatering af materialet.
English: Medical treatment may be necessary.
Danish: Akut medicinsk behandling kan være nødvendig.
English: The study enrolled 145 adult and 21 paediatric patients.
Danish: I studiet deltog 145 voksne og 21 pædiatriske patienter.
English: Show them the pack of tablets.
Danish: Vis lægen pakken med tabletter.
English: - Thereafter
Danish: - Herefter
English: • If you get reduced hearing, tell your doctor as soon as possible.
Danish: • Hvis du får nedsat hørelse, så fortæl det til lægen hurtigst muligt.
English: This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions.
Danish: Dette skyldes, at blod indeholder jern, og at din krop ikke har en naturlig metode til at fjerne det overskydende jern, du får med blodtransfusionerne.
English: Over time, the excess iron can damage important organs such as the liver and heart.
Danish: På længere sigt kan det overskydende jern ødelægge vigtige organer såsom leveren og hjertet.
English: However, repeated blood transfusions can cause a build-up of excess iron.
Danish: Imidlertid kan gentagne blodtransfusioner forårsage ophobning af overskydende jern.
English: LLN: lower limit of the normal range
Danish: LLN: nedre grænse af normalområdet
English: The rashes resolve spontaneously in most cases.
Danish: Udslættene forsvinder spontant i de fleste tilfælde.
English: Every 2 weeks during first month of therapy.
Danish: Hver 2. uge den første behandlingsmåned.
English: The film-coated tablets should be swallowed whole with some water.
Danish: Filmovertrukne tabletter bør sluges hele med lidt vand.
English: Do not take a double dose on the next day to make up for the forgotten tablet(s).
Danish: Du må ikke tage en dobbeltdosis den næste dag som erstatning for de(n) glemt(e) tablet(ter).
English: After 20 units (about 100 ml/kg) of PRBC
Danish: Efter 20 enheder (ca. 100 ml/kg) af PRBC
English: There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended.
Danish: Der er ingen tilgængelige data for genoptagelse af behandlingen hos patienter, der genophober jern efter at have opnået et tilfredsstillende jernniveau i kroppen, og derfor kan det ikke anbefales at genoptage behandlingen.
English: Gastrointestinal perforation 1, acute pancreatitis
Danish: Gastrointestinal perforation 1, akut pankreatitis
English: In severe cases, this reintroduction could be conducted in combination with a short period of oral steroid administration.
Danish: I alvorlige tilfælde kan denne behandling påbegyndes igen i kombination med en kort periode med oralt administreret steroid.
English: The causes of the rises in serum creatinine have not been elucidated.
Danish: Årsagerne til stigningerne i serum-kreatinin er ikke blevet klarlagt.
English: Acidbase balance should be monitored as clinically indicated in these populations.
Danish: Syre-basebalance, bør overvåges som klinisk indiceret i disse populationer.
English: Annually thereafter.
Danish: Årligt herefter.
English: In children younger than 6 years old exposure was about 50% lower than in adults.
Danish: Hos børn under 6 år var eksponeringen omkring 50 % lavere end hos voksne.
English: In patients treated with doses >21 mg/kg/day - When target is reached
Danish: Til patienter behandlet med doser > 21 mg/kg/dag - Når målet er nået
English: Acute pancreatitis has been reported, particularly in children and adolescents.
Danish: Der er blevet rapporteret om akut pancreatitis, særligt hos børn og unge.
English: - busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant).
Danish: - busulfan (bruges som behandling for at ødelægge den originale knoglemarv inden en transplantation).
English: If possible, evaluation of the pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose adjustment.
Danish: Om muligt skal farmakokinetikken (AUC, clearance) af en busulfan testdosis evalueres for at muliggøre dosisjustering.
English: [Blisters]
Danish: [Blister]
English: No such effects were observed in iron-preloaded rats.
Danish: Sådanne effekter blev ikke set hos jern-præeksponerede rotter.
English: X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Danish: Værdi 2 X og Y er dagene (skal fastsættes), hvor målingerne før behandling skal udføres.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.