FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasmar, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Tasmar, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Danish: Det aktive stof i Tasmar, tolcapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: The main measure of effectiveness was how long the patients spent in the ‘off' or in the ‘on' state.
Danish: Det primære effektmål var, i hvor lang tid patienterne var i "on"- eller ”off”tilstand.
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler i hjernen, der producerer neurotransmitteren dopamin, at dø, og hjernens dopaminindhold falder.
English: What is the risk associated with Tasmar?
Danish: Hvilken risiko er der forbundet med Tasmar?
English: Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.
Danish: Tasmar må ikke anvendes til patienter, der behandles med lægemidler, der kaldes ikke-selektive monoaminoxidasehæmmere.
English: Tasmar can cause liver injury, which can be fatal in rare cases.
Danish: Tasmar kan beskadige leveren, i sjældne tilfælde med døden til følge.
English: For the full list of restrictions see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: The main measure of effectiveness was the number of patients with an increase in ‘on' time of one hour or more, during the three weeks following the switch.
Danish: Det primære effektmål var antallet af patienter, der opnåede en forlængelse af "on"-perioden på mindst en time i løbet af tre uger efter lægemiddelskiftet.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Danish: Parkinsons sygdom er en fremadskridende hjernesygdom, der medfører rysten, langsomme bevægelser og muskelstivhed.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke);
Danish: • tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, der sædvanligvis skyldes antipsykotiske lægemidler), rhabdomyolyse (nedbrydning af muskelfibrene) eller hedeslag,
English: Tasmar is used together with other standard treatments for Parkinson's disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have ‘fluctuations' towards the end of the period between two doses of their standard combination.
Danish: Tasmar anvendes sammen med andre standardlægemidler til behandling af Parkinsons sygdom (enten en kombination af levodopa og benserazid eller en kombination af levodopa og carbidopa), når patienterne får ”fluktuationer”' hen mod slutningen af perioden mellem to doser af standardkombinationen.
English: The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), loss of appetite, diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
Danish: De hyppigste bivirkninger ved Tasmar (som optræder hos flere end 1 ud af 10 patienter) er kvalme, appetitløshed, diarré, bevægelsesvanskeligheder, muskeltrækninger, hovedpine, svimmelhed, søvnforstyrrelser, forstærket drømmetendens, søvnighed, forvirring, sansebedrag og svimmelhed i oprejst stilling.
English: When patients add Tasmar to their existing anti Parkinson's disease medication, they need to be made aware that they may experience some of the side effects of levodopa, although these can often be reduced by lowering the dose of levodopa.
Danish: Når Tasmar gives som tillægsbehandling til den Parkinson-behandling, patienterne får i forvejen, skal de gøres opmærksom på, at de kan få nogle af bivirkningerne ved levodopa, men at dette ofte kan afhjælpes ved at mindske levodopa-dosis.
English: Tasmar is used to treat patients with Parkinson's disease.
Danish: Tasmar anvendes til behandling af Parkinsons sygdom.
English: Tasmar is always given with levodopa and benserazide or with levodopa and carbidopa.
Danish: Tasmar anvendes altid i kombination med enten levodopa og benserazid eller med levodopa og carbidopa.
English: What is Tasmar?
Danish: Hvad er Tasmar?
English: Why has Tasmar been approved?
Danish: Hvorfor blev Tasmar godkendt?
English: For the full list of all side effects reported with Tasmar, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tasmar fremgår af indlægssedlen.
English: All of the studies compared Tasmar with placebo (a dummy treatment) when they were added to the patient's existing medication (levodopa and either carbidopa or benserazide).
Danish: I alle undersøgelserne sammenlignedes Tasmar med placebo (en virkningsløs behandling) som tillægsbehandling til den behandling, patienten fik i forvejen (levodopa og enten carbidopa eller benserazid).
English: Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catecholO-methyl transferase (COMT).
Danish: Tolcapon blokerer et enzym catechol-O-methyltransferase (COMT), som medvirker ved nedbrydningen af levodopa i kroppen.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Danish: • fæokromocytom (en svulst i binyrerne),
English: The CHMP decided that Tasmar's benefits are greater than its risks in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Danish: CHMP konkluderede, at fordelene ved Tasmar opvejer risiciene som tillægsbehandling til levodopa/benserazid eller levodopa/carbidopa hos patienter med levodopa-følsom Parkinsons sygdom af ukendt årsag og motoriske fluktuationer og som ikke reagerer på eller tolerer andre COMT-hæmmere.
English: Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Danish: Fluktuationer er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "off-perioder", hvor patienten er immobil.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Danish: Levodopa svarer til neurotransmitteren dopamin, som kan tages gennem munden.
English: What is Tasmar used for?
Danish: Hvad anvendes Tasmar til?
English: As a result, levodopa remains active for longer.
Danish: Derved forlænges virkningen af levodopa.
English: How has Tasmar been studied?
Danish: Hvordan blev Tasmar undersøgt?
English: There was a reduction of about 20 to 30% in ‘off' time in patients taking Tasmar.
Danish: Hos patienter, som fik Tasmar, bevirkede det, at "off"-perioderne blev reduceret med 20 til 30 %.
English: What benefit has Tasmar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tasmar?
English: How is Tasmar used?
Danish: Hvordan anvendes Tasmar?
English: Treatment should be stopped in patients who develop liver problems.
Danish: Hvis patienten får leverproblemer, skal behandlingen afbrydes.
English: How does Tasmar work?
Danish: Hvordan virker Tasmar?
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide physicians who are expected to prescribe/use Leflunomide medac with a physician educational pack containing the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen (MAH) vil forsyne alle læger, som forventes at ordinere/anvende Leflunomide medac, med en undervisningspakke for læger indeholdende følgende:
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Danish: Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Danish: Læger og patienter skal gøres opmærksomme på, at der findes en ad hocinformationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Danish: • At der er risiko for teratogen effekt og at svangerskab derfor skal undgås, indtil plasmaniveauet af leflunomid er passende.
English: The Physician Leaflet should contain the following key messages:
Danish: Informationsfolderen til læger bør indeholde følgende nøgleinformation:
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Danish: • Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs) (f.eks. methotrexat)
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Danish: • At der er risiko for alvorlig leverskade, og det derfor er vigtigt med regelmæssige målinger af ALAT (SGPT) for at overvåge leverfunktionen.
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Danish: • Behovet for rådgivning af patienter om vigtige risici i forbindelse med behandling med leflunomid og passende forholdsregler under behandlingen.
English: • The Summary of Product Characteristics • Physician Leaflet
Danish: • Produktresumé • Informationsfolder til læger
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: None known.
Danish: Ingen kendte.
English: Recovery occurs normally within 24-36 hours after treatment.
Danish: Genopretning sker normalt inden for 24-36 timer efter behandling.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: These effects will usually resolve without treatment.
Danish: Disse bivirkninger vil sædvanligvis forsvinde uden behandling.
English: 0.5 Minimum of 15 Minimum of 48
Danish: 0,5 Minimum 15 Minimum 48
English: A dry white residue may also be observed.
Danish: Tørre hvide rester kan også ses.
English: ATCvet code: QP53AC54.
Danish: ATCvet kode: QP53AC54.
English: Batch {number}
Danish: Batch {nummer}
English: 1 pipette 4 pipettes 6 pipettes
Danish: 1 pipette 4 pipetter 6 pipetter
English: Method of administration:
Danish: Administrationsmetode:
English: All dogs in a household should be treated with a suitable flea product.
Danish: Alle hunde i husstanden bør behandles med et egnet loppemiddel.
English: • administer the product in a well-ventilated area;
Danish: • administrer lægemidlet et sted, hvor der er god ventilation
English: For application to the dog's skin only.
Danish: Kun til anvendelse på hundens hud.
English: • wear protective gloves when handling or applying the product;
Danish: • brug beskyttelseshandsker ved håndtering eller administration af lægemidlet
English: EXP {month/year}
Danish: EXP {måned/år}
English: In case of accidental exposure of cats:
Danish: I tilfælde af utilsigtet eksponering hos katte:
English: However, potential transmission of infectious disease by sand flies cannot be excluded if conditions are unfavourable.
Danish: Imidlertid kan potentiel overførsel af smitsomme sygdomme fra sandfluer ikke udelukkes, hvis forholdene er ugunstige.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Danish: Man må ikke spise, drikke eller ryge når man håndterer det veterinære lægemiddel.
English: The appropriate combination of pipettes should be used
Danish: Den passende kombination af ovenstående pipetter bør anvendes
English: If this occurs, rinse slowly and gently with water.
Danish: Hvis dette sker, skyl langsomt og forsigtigt med vand.
English: Activyl Tick Plus should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: Activyl Tick Plus må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktive stoffer:
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år.
English: Pentobarbital, phenobarbital or propofol might be indicated if repeated occasions of cramp/tremors occur.
Danish: Pentobarbital, phenobarbital eller propofol kan være indiceret, hvis der opstår gentagne tilfælde af kramper/tremor.
English: One size of unit-dose pipette only per box.
Danish: Kun en størrelse pipetter per æske.
English: This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours.
Danish: Dette medfører et hurtigt indsættende stop for fødeindtagelse inden for 0 til 4 timer efter behandling, efterfulgt af et stop i æglægning (oviposition), paralyse og død inden for 4 til 48 timer.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG
English: This product is highly flammable.
Danish: Dette produkt er letantændeligt.
English: Used pipettes should be disposed of immediately.
Danish: Brugte pipetter bør smides ud med det samme.
English: insecticides; permethrin, combinations.
Danish: insecticider, permethrin, kombinationer.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton, foil and pipette after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken, aluminiumsfoliebrevet og pipetten efter forkortelsen 'EXP'.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Danish: VETERINÆRLÆGEMIDLETS NAVN
English: A proper treatment of the pet´s environment by additional chemical or physical measures is recommended.
Danish: Derudover anbefales en grundig behandling af kæledyrets omgivelser med kemiske midler eller fysiske foranstaltninger.
English: Weight of dog (kg)
Danish: Hundens vægt (kg)
English: Step 2: The dog should be standing for easy application.
Danish: Trin 2: Hunden bør stå op for at lette applikationen.
English: One pipette delivers:
Danish: En pipette giver:
English: Absorption through the skin also occurs, but this systemic absorption is partial and not relevant for the clinical efficacy.
Danish: Der sker ligeledes en absorption igennem huden, men den systemiske absorption er kun delvis og ikke relevant for den kliniske virkning.
English: These signs are usually transient and generally resolve within 24 - 48 hours.
Danish: Disse symptomer er normalt forbigående og forsvinder som regel inden for 24-48 timer.
English: The following table defines the size of pipette to be used according to the weight of the dog:
Danish: Nedenstående tabel angiver, hvilken størrelse pipette der skal anvendes, afhængigt af hundens vægt:
English: No adverse reactions were observed in dogs aged 8 weeks and older, treated 8 times at 4 week intervals or 6 times at 2 week intervals, with 5 times the recommended dose.
Danish: Der blev ikke set bivirkninger hos hunde der var 8 uger eller ældre, behandlet 8 gange med 4 ugers interval eller 6 gange med 2 ugers interval, med 5 gange den anbefalede dosis.
English: For this reason the transmission of infectious diseases by ticks cannot be excluded.
Danish: Derfor kan overførsel af smitsomme sygdomme fra skovflåter ikke udelukkes.
English: Do not administer orally or via any other route.
Danish: Må ikke administreres oralt eller via nogen anden indgivelsesvej.
English: The pipette consists of a blister film (polypropylene/cyclic-olefin- copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium child-resistant sachet.
Danish: Pipetten består af en blisterfilm (polypropylen/cyclic-olefin-copolymer/polypropylen) og et folielåg (aluminium/polypropylen co-ekstruderet) forseglet i børnesikrede aluminiumsbreve.
English: To avoid adverse reactions:
Danish: For at undgå bivirkninger:
English: The product should not be used in dogs younger than 8 weeks or dogs weighing less than 1.2 kg.
Danish: Produktet bør ikke anvendes til hunde yngre end 8 uger eller hunde, der vejer mindre end 1,2 kg.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (pipette label)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER (pipette label)
English: STATEMENT OF ACTIVE SUBSTANCES
Danish: ANGIVELSE AF AKTIVE STOFFER
English: This product is for external topical application only.
Danish: Dette produkt er kun beregnet til udvortes topikal applikation.
English: A clear, colourless to yellow or brown-coloured solution.
Danish: En klar, farveløs til gul eller brunfarvet opløsning.
English: 10 DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: In case of frequent shampooing, the duration of activity may be reduced.
Danish: Ved hyppig vask kan virkningstiden reduceres.
English: People with known hypersensitivity to indoxacarb and/or permethrin should avoid contact with this product.
Danish: Personer med kendt overfølsomhed over for indoxacarb og/eller permethrin bør undgå kontakt med dette produkt.
English: Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35
Danish: Indehaver af markedsføringstilladelsen: Intervet International BV Wim de Körverstraat 35
English: Special precautions for use in animals: The product should not be used in dogs younger than 8 weeks or dogs weighing less than 1.2 kg.
Danish: Særlige forholdsregler vedrørende brug til dyr: Produktet bør ikke anvendes til hunde yngre end 8 uger eller hunde, der vejer mindre end 1,2 kg.
English: • on the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children;
Danish: • lad ikke børn berøre dyret samme dag, som det er blevet behandlet, og lad ikke dyret sove i samme seng som dets ejer, især ikke hos børn
English: Developing stages of fleas in the dog's immediate surroundings are killed following contact with the treated dogs.
Danish: Loppens forskellige udviklingsstadier, der findes i hundens nærmeste omgivelser, bliver dræbt, når de kommer i kontakt med behandlede hunde.
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: Eventuelle ubrugte veterinære lægemidler eller affald fra sådanne veterinære lægemidler skal destrueres i overensstemmelse med de lokale krav.
English: Propyl gallate (E310) Propylene glycol monomethyl ether (Dowanol PM)
Danish: Propylgallat (E310) Propylenglycolmonomethylether (Dowanol PM)
English: Keep away from heat, sparks, open flame or other sources of ignition.
Danish: Må ikke opbevares i nærheden af varme, gnister, åben ild eller anden antændingskilde.
English: These changes do not affect the safety or efficacy of the veterinary medicinal product.
Danish: Disse forandringer har ingen indflydelse på det veterinære lægemiddels sikkerhed eller virkning.
English: Permethrin belongs to the Type I class of pyrethroids, which are acaricides and insecticides with repellent activity.
Danish: Permethrin tilhører Type 1-klassen af pyrethroider, som er acaricider og insekticider med repellerende virkning.
English: Intervet Productions SA Rue de Lyons 27460 Igoville France
Danish: Intervet Productions SA Rue de Lyons 27460 Igoville Frankrig
English: After treatment, ticks will generally be killed and fall off the host within 48 hours after infestation without having had a blood meal but an attachment of single ticks after treatment cannot be excluded.
Danish: Flåter vil generelt blive dræbt efter behandling og falde af værten inden for 48 timer efter infestation uden at have suget blod, men det kan ikke udelukkes, at enkelte flåter sætter sig fast efter behandlingen.
English: For larger dogs, apply the contents of the pipette evenly to 2 (medium dogs) or 3 (large dogs) or 4 (very large dogs) spots along the backline from the shoulder to the base of the tail.
Danish: Ved behandling af større hunde bør pipettens indhold fordeles ligeligt på 2 (mellemstore hunde) eller 3 (store hunde) eller 4 (ekstra store hunde) steder langs ryggens midtlinje fra skulderen til haleroden.
English: Step 1: Hold the pipette in an upright position away from your face.
Danish: Trin 1: Hold pipetten med spidsen opad og pegende væk fra dit ansigt.
English: Manufacturer responsible for batch release: Intervet Productions SA Rue de Lyons
Danish: Fremstiller ansvarlig for batchfrigivelse: Intervet Productions SA Rue de Lyons
English: The veterinary medicinal product remains effective when treated dogs are exposed to sunlight or immersed in water (e.g. swimming, bathing).
Danish: Det veterinære lægemiddel forbliver effektivt, selvom den behandlede hund udsættes for sollys eller vand (f.eks. svømning og badning).
English: Part the hair until the skin is visible and place the pipette tip against the skin between the shoulder blades.
Danish: Skil hårene indtil huden er synlig og placér pipettespidsen mod huden mellem skulderbladene.
English: The frequency of adverse reactions is defined using the following convention:
Danish: Hyppigheden af bivirkninger er defineret som:
English: 40.1 - 60 Extra large dogs
Danish: 40,1 - 60 Ekstra store hunde
English: Following a single spot-on application of the product, indoxacarb and permethrin can still be detected in both skin and hair coat after 4 weeks post-treatment.
Danish: Efter en enkelt spot-on applicering af produktet kan indoxacarb og permethrin stadig findes i både hud og hår 4 uger efter behandling.
English: Ticks already attached on the dog may not be killed within two days after treatment and may remain attached and visible.
Danish: Fastsiddende flåter på hunden dræbes ikke nødvendigvis inden for 2 dage efter behandling og kan forblive fastsiddende og synlige.
English: • wash hands immediately after use and wash off any product in contact with the skin immediately with soap and water;
Danish: • vask hænder straks efter brug og vask straks med vand og sæbe, hvis lægemidlet kommer i kontakt med huden.
English: Veterinary medicinal product not subject to prescription.
Danish: Lægemidlet er ikke veterinærreceptpligtigt.
English: If ticks of these species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week.
Danish: Hvis flåter af disse arter er til stede når præparatet appliceres, er det ikke sikkert at de alle dræbes inden for 48 timer, men forventeligt inden for en uge.