FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketoprofen may cause adverse reactions typical to non-steroidal anti-inflammatory drugs, such as diarrhoea which is caused by gastro-intestinal irritation and ulceration.
Danish: Ketoprofen kan give bivirkningsreaktioner, som er karakteristiske for nonsteroide antiinflammatoriske lægemidler, f.eks. diaré, forårsaget af irritation og sårdannelse i mavetarmkanalen.
English: Box 99, 24101 Salo The manufacturer responsible for batch release: Galena Oy, P.O.Box 1450, 70501 Kuopio, Finland 16.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Indehaver af markedsføringstilladelse: Vetcare Oy, P.O. Box 99, FI-24101 Salo, Finland Fremstiller: Galena Oy, P.O. Box 1450, FI-70501 Kuopio, Finland
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER The marketing authorisation holder: Vetcare Oy, P.O.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Meat and offal: 1 day.
Danish: Slagtning: 1 døgn.
English: TARGET SPECIES Cattle (adult cattle weighing about 600 kg).
Danish: DYREARTER Kvæg (voksent kvæg på ca. 600 kg)
English: PHARMACOLOGICAL PROPERTIES
Danish: FARMAKOLOGISKE OG FARMAKOKINETISKE OPLYSNINGER
English: 4.2 Indications for use, specifying the target species Alleviation of inflammation and reduction of fever in individual animals 4.3 Contraindications
Danish: INDIKATIONER Lindring af inflammation og feberreduktion hos individuelle dyr.
English: Box 99, 24101 Salo.
Danish: Vetcare Oy P.O. Box 99 FI-24101 Salo Finland
English: Batch
Danish: UDL.
English: Other non steroidal anti-inflammatory drugs (NSAID) must not be used simultaneously with the product and within 24 hours after the last dose of Dolovet, because the substances may compete in binding with proteins thus leading to toxic effects.
Danish: Andre nonsteroide antiinflammatoriske lægemidler (NSAID) må ikke bruges sammen med Dolovet Vet. og i op til 24 timer efter den sidste dosis af præparatet.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ketoprofen 2.4 g, constit.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Ketoprofen.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: Beholder og eventuelt restindhold tilbageleveres til apotek/leverandør eller til kommunal modtageordning.
English: Strength Animal species
Danish: DYREARTER
English: WITHDRAWAL PERIOD Meat and offail: 1 day Milk: zero days.
Danish: 10. TILBAGEHOLDELSESTID Slagtning: 1 døgn.
English: 2.4g ketoprofen per sachet of 15g powder
Danish: Hver pose med 15 g pulver indeholder 2,4 g ketoprofen
English: PACKAGE LEAFLET Dolovet vet 2.4 g oral powder NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing authorisation holder: Vetcare Oy, P.O.Box 99, 24101 Salo, Finland.
Danish: Indehaver af markedsføringstilladelsen: Vetcare Oy, P.O. Box 99, FI-24101 Salo, Finland.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn
English: METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY Orally for adult cattle weighing about 600 kg bw.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ Oral anvendelse til voksent kvæg på ca. 600 kg: 1 brev à 15 g en gang dagligt i 1-3 dage.
English: : One bag of 15 g once daily for 1 - 3 days.
Danish: Oral anvendelse til voksent kvæg på ca. 600 kg: 1 brev à 15 g en gang dagligt i 1-3 dage.
English: Milk: zero days.
Danish: 0 døgn.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION FI: 22.09.2003
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE [Dato]
English: Chicory root should only be used in adults and children over the age of 12 years.
Danish: Cikorierod bør kun anvendes til voksne og børn over 12 år.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Dette betyder, at selv om der ikke er tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkertpå denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: EMA/HMPC/286842/2013
Danish: Cikorierod EMA/HMPC/286842/2013
English: Chicory root is the common name for the root of the plant Cichorium intybus L. The plant is cultivated or gathered to obtain the root for medicinal use.
Danish: Cikorierod er fællesnavnet for roden fra planten Cichorium intybus L. Planten dyrkes eller indsamles for at høste roden til medicinsk anvendelse.
English: What is chicory root?
Danish: Hvad er cikorierod?
English: A doctor should be consulted if the symptoms persist following 2 weeks of treatment.
Danish: Hvis symptomerne vedbliver efter to ugers behandling, bør der søges læge.
English: Chicory root can also be found in combination with other herbal substances in some herbal medicines.
Danish: Cikorierod findes desuden kombineret med andre droger i visse plantelægemidler.
English: Information on the use and licensing of chicory root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder cikorierod, skal indhentes fra de relevante nationale myndigheder.
English: This summary is not intended to provide practical advice on how to use medicines containing chicory root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan lægemidler, der indeholder cikorierod, anvendes.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of chicory root.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af cikorierod.
English: Any applications for the licensing of medicines containing chicory root 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 cikorierod, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: The HMPC conclusions on the use of chicory root medicines for the relief of symptoms of mild digestive disorders and temporary loss of appetite are based on their ‘traditional use'.
Danish: HMPC's konklusioner om brugen af lægemidler med cikorierod til lindring af symptomer på milde fordøjelsesforstyrrelser og midlertidig appetitløshed er baseret på den "traditionelle anvendelse".
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing chicory root.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder cikorierod.
English: Further information on the risks associated with chicory root 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 lægemidlermed cikorierod, 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: Further information on the HMPC assessment of chicory root 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 cikorierod, 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: In its assessment, the HMPC took into account the well documented use of chicory root in digestive disorders and loss of appetite.
Danish: I vurderingen har HMPC taget hensyn til den veldokumenterede anvendelse af cikorierod til fordøjelsesbesvær og appetitløshed.
English: Detailed instruction on how to take chicory root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med cikorierod skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Other information about chicory root medicines
Danish: Andre oplysninger om lægemidler, der indeholder cikorierod
English: How are chicory root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder cikorierod, i EU?
English: Chicory root
Danish: Cikorierod
English: What are the risks associated with chicory root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder cikorierod?
English: The HMPC concluded that, on the basis of its long-standing use, chicory root can be used for the relief of symptoms of mild digestive disorders (such as feeling full, flatulence and slow digestion) and temporary loss of appetite.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at cikorierod kan anvendes til lindring af symptomer på mild fordøjelsesbesvær (såsom mæthedsfornemmelse, tarmluft (flatulens) og langsom fordøjelse) samt midlertidig appetitløshed.
English: Herbal medicines containing chicory root are usually available as herbal tea to be drunk.
Danish: Plantelægemidler med cikorierod fås normalt som urtete til drikkebrug.
English: What evidence supports the use of chicory root medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af cikorierod?
English: In addition, the HMPC considered that chicory rood contains bitter substances that may stimulate appetite and also a study in the laboratory, which showed an effect of chicory root in stimulating an increased secretion of bile (a fluid produced in the liver that helps to break down fats), thereby supporting its use in digestive disorders.
Danish: Desuden er inddraget en laboratorieundersøgelse, hvor det blev påvist, at cikorierod virker ved at stimulere og øge galdesekretionen (væske, der produceres i leveren, og som hjælper med at nedbryde fedtstoffer), hvilket underbygger lægemidlets anvendelse ved fordøjelsesbesvær.
English: For more information about treatment with chicory root 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 cikorierod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using chicory root 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 cikorierod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Chicory root preparations are obtained by comminuting the roots (reducing them into tiny pieces).
Danish: Cikorierod anvendes i form af findelte rødder.
English: Committee on Herbal Medicinal Products (HMPC)
Danish: EMA/HMPC/286842/2013 Udvalget for Plantelægemidler (HMPC)
English: You should take your medicine at the same time each day.
Danish: Du skal tage medicinen på samme tid hver dag.
English: Elimination Following an oral dose of
Danish: Elimination Efter en oral dosis af
English: a recent serious injury.
Danish: - en nylig alvorlig kvæstelse.
English: Contact your doctor immediately if you experience:
Danish: Kontakt din læge med det samme, hvis du oplever:
English: Very rare, not known
Danish: Sjælden Meget sjælden, ikke kendt
English: 15 months
Danish: 15 måneder.
English: Caution required due to ASA
Danish: Forsigtighed påkrævet på grund af ASA
English: Date of first authorisation: Date of latest renewal:
Danish: Dato for første godkendelse: Dato for seneste fornyelse:
English: Contact your doctor before stopping or restarting your treatment.
Danish: Kontakt din læge, før du stopper eller genoptager din behandling.
English: The clinical relevance is unknown.
Danish: Den kliniske relevans er ukendt.
English: Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial.
Danish: Derfor bør en sådan tilføjelse udføres med forsigtighed uden for kliniske situationer, hvor kombinationen har vist sig at være gavnlig.
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Danish: Den absolutte risiko for kardiovaskulære misdannelser blev øget fra mindre end 1 % til ca. 1,5 %.
English: It is recommended that patients not be given salicylates for an interval of six weeks after receiving the varicella vaccine.
Danish: Det anbefales, at patienter ikke får salicylater i et interval på seks uger efter at have fået varicellavaccine.
English: In addition, due to the presence of ASA, its use is also contraindicated in:
Danish: På grund af tilstedeværelsen af ASA er brugen desuden kontraindiceret i tilfælde af:
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Danish: Derudover gav sikkerhedsprofilen for denne patientundergruppe ikke anledning til særlig betænkelighed.
English: Thus, the results from this subset are in line with the overall trial results.
Danish: Dermed er resultaterne fra denne delmængde i overensstemmelse med de overordnede studieresultater.
English: Rhone 69800, France
Danish: Rhone 69800, Frankrig
English: Given that children, infants and toddlers are often only seen at a late stage of intoxication, they will usually have already reached the acidosis stage.
Danish: Da børn, nyfødte og småbørn ofte ses på et sent tidspunkt i forgiftningsprocessen, har de sædvanligvis allerede nået acidose-stadiet.
English: Other interactions with ASA
Danish: Andre interaktioner med ASA
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Danish: Følgelig kan en direkte effekt (let toksitet) eller en indirekte effekt (mindre velsmagende) ikke udelukkes.
English: • In children under 18 years of age, there is a possible association between ASA and Reye's syndrome.
Danish: • Hos børn under 18 år er der en mulig sammenhæng mellem ASA og Reyes syndrom.
English: It is preferable not to take this medicine during first and second trimesters of pregnancy.
Danish: Det er bedst ikke at tage dette lægemiddel under graviditetens første og andet trimester.
English: If you have had a heart attack, it should be prescribed for at least four weeks.
Danish: Hvis du har haft et hjerteanfald, skal medicinen udskrives til mindst fire uger.
English: Although no formal carcinogenicity studies have been performed with ASA, it has been shown that it is not a tumour promoter.
Danish: Selvom der ikke er udført formelle karcinogenicitetsstudier med ASA, er det blevet vist, at det ikke er en tumorpromoter.
English: Following toxic doses (10-20 g), the plasma half-life may be increased to over 20 hours.
Danish: Efter toksiske doser (10-20 g) kan plasmahalveringstiden øges til over 20 timer.
English: • Your doctor may order blood tests.
Danish: • kan din læge bede om at få taget blodprøver.
English: Periodic safety update reports (PSURs)
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: ASA is poorly bound to plasma proteins and its apparent volume of distribution is low (10 l).
Danish: ASA bindes dårligt til plasmaproteiner, og dets tilsyneladende distributionsvolumen er lavt (10 l).
English: The risk is believed to increase with dose and duration of therapy.
Danish: Denne risiko menes at stige i takt med dosis og behandlingsvarighed.
English: • fever, signs of infection or extreme tiredness.
Danish: • feber, tegn på infektion eller ekstrem træthed.
English: Anti-retroviral therapies (ART)
Danish: Antiretrovirale behandlinger (ART)
English: Single-dose studies have shown that the oral toxicity of ASA is low.
Danish: Enkeltdosisundersøgelser har vist, at den orale toksicitet af ASA er lav.
English: You should not breast-feed while using this medicine.
Danish: Du bør ikke amme, mens du tager dette lægemiddel.
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Danish: Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i resultat hos personer med ringe metabolisme.
English: This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
Danish: Dette randomiserede, open-label studie inkluderede 2.610 biomarker-positive ACS-patienter efter vellykket PCI.
English: • Third trimester of pregnancy (see section 4.6).
Danish: • Tredje trimester af graviditeten (se pkt.
English: This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours.
Danish: Denne fordel var konsistent på tværs af alder, køn og med eller uden fibrinolytika og blev observeret allerede efter omkring 24 timer.
English: Initial hyperventilation leads to respiratory alkalosis.
Danish: Initial hyperventilation fører til respiratorisk alkalose.
English: In addition, your doctor may identify changes in your blood or urine tests.
Danish: Derudover kan din læge eventuelt finde ændringer i resultaterne af dine blod- eller urinprøver.
English: Biotransformation and Elimination
Danish: Biotransformation og elimination
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt dødelig tilstand, der kræver øjeblikkelig behandling inklusive plasmaferese.
English: Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Danish: Selv om den iskæmiske fordel var konsistent i løbet af det første år, blev der observeret større reduktion i iskæmisk tilbagefald efter ACS i de første dage efter indledning af behandlingen.
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Danish: Ved lave koncentrationer (< 100 mikrogram/ml) er ca. 90 % af salicylsyren bundet til albumin.
English: Treat other signs of intoxication symptomatically.
Danish: Andre tegn på forgiftning behandles symptomatisk.
English: Therefore, this combination should be used with caution in patients taking low dose ASA for cardioprotection.
Danish: Derfor bør denne kombination anvendes med forsigtighed hos patienter, der får lavdosis ASA for kardioprotektion.
English: ASA is known to be excreted in limited amounts in human milk.
Danish: Det er kendt, at ASA udskilles i begrænsede mængder i human mælk.
English: For minor cuts and injuries e.g., cutting yourself shaving, this is usually of no concern.
Danish: Ved mindre sår og skader, som hvis du f.eks. skærer dig under barbering, er dette som regel ikke noget problem.
English: Varicella vaccine
Danish: Varicellavaccine
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret ud fra de følgende kategorier: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden < 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Minor GI symptoms, such as dyspepsia, are common and can occur anytime during therapy.
Danish: Mindre GI- symptomer såsom dyspepsi er almindelige og kan forekomme på alle tidspunkter under behandlingen.
English: • if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.
Danish: • hvis du har haft tidligere tilfælde af astma eller allergiske reaktioner inklusive allergi mod et lægemiddel, der anvendes til at behandle din sygdom.
English: Cytochrome P450 2C19 (CYP2C19)
Danish: Cytokrom P450 2C19 (CYP2C19
English: An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
Danish: Der er ikke etableret et passende dosisregime for denne patientpopulation i kliniske resultat-studier.
English: There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day.
Danish: Der findes ikke tilstrækkelig klinisk erfaring vedrørende anvendelsen af doser over 100 mg/dag og op til 500 mg/dag.
English: Platelets are very small structures in the blood which clump together during blood clotting.
Danish: Blodplader er meget små bestanddele i blodet, som klumper sig sammen, når blodet størkner.
English: A patient with poor metaboliser status will possess two loss-of function alleles as defined above.
Danish: En patient med status nedsat metabolisme vil besidde to ikke-funktionelle alleler, som beskrevet ovenfor.
English: • if you are in your last trimester of pregnancy.
Danish: • hvis du er gravid i tredje trimester.
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Danish: Patientpopulationen bestod af 19,7 % kvinder, og 29,2 % af patienterne var over 65 år.
English: a planned surgery (including dental) in the next seven days.
Danish: - et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage.
English: 117 Allee Des Parcs, St Priest,
Danish: 117 Allée Des Parcs, St. Priest,
English: Other interactions with clopidogrel and ASA
Danish: Andre interaktioner med clopidogrel og ASA
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Danish: I CURE blev 823 (6,6 %) patienter samtidigt behandlet med GPIIb/IIIa-receptorantagonist.
English: • In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Danish: • Hos patienter med akut myokardieinfarkt med elevation af ST-segmentet: Behandling bør startes så tidligt som muligt, efter symptomerne viser sig, og fortsættes i mindst 4 uger.
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Danish: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) Dette randomiserede, open-label studie inkluderede ACS patienter, som kræver PCI.
English: For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Danish: For at behandle denne tilstand kan lægen have indopereret en stent (rør) i den blokerede eller forsnævrede blodåre (arterie) for at genoprette en effektiv blodgennemstrømning.