FrancophonIA/ELRC3.0 huggingface dataset:
English: • Rapid heartbeat.
Danish: • Hurtig hjerterytme (puls)..
English: Each tablet contains 200 mg quetiapine (as fumarate)
Danish: Hvar tablet indeholder 200 mg quetiapin (som fumarat)
English: 6 blisters of 10 tablets
Danish: 6 blistre á 10 tabletter
English: Each tablet contains 150 mg quetiapine (as fumarate)
Danish: Hvar tablet indeholder 150 mg quetiapin (som fumarat)
English: (13) See text below (14) Platelets ≤100 x 109/L on at least one occasion (15) Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome (16) Prolactin levels (patients >18 years of age): >20 μg/L (>869.56 pmol/L) males; >30 μg/L (>1304.34 pmol/L) females at any time.
Danish: (16) Prolaktinniveauer (patienter >18 år): >20 μg/l (>869,56 pmol/l) hankøn: >30 μg/l (>1304,34 pmol/l) hunkøn ved ethvert tidspunkt.
English: • Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
Danish: Du bør derfor tage tabletterne mindst 1 time før et måltid eller ved sengetid.
English: Each tablet contains 300 mg quetiapine (as fumarate)
Danish: Hvar tablet indeholder 300 mg quetiapin (som fumarat)
English: • treatment of bipolar disorder : o For the treatment of moderate to severe manic episodes in bipolar disorder o For the treatment of major depressive episodes in bipolar disorder o For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment .
Danish: • behandling af bipolar lidelse: o Til behandling af moderate til svære maniske episoder inden for bipolar lidelse.
English: Each tablet contains 400 mg quetiapine (as fumarate)
Danish: Hvar tablet indeholder 400 mg quetiapin (som fumarat)
English: 10 blisters of 10 tablets
Danish: 10 blistre á 10 tabletter
English: • Do not drink grapefruit juice while you are taking Seroquel XR .
Danish: Du må ikke drikke grapefrugtjuice, når du tager Seroquel Prolong, da det kan påvirke den måde, medicinen virker.
English: Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose.
Danish: Der kan være en øget risiko ved overdosering hos patienter med kendt alvorlig kardiovaskulær sygdom (se pkt.
English: Fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
Danish: Tal med din læge med det samme, hvis du: - Får feber, alvorlig muskelstivhed, svedtendens eller nedsat bevidsthed (en lidelse, som hedder
English: Orthostatic hypotension 4, 17 Venous thromboembolism1 Respiratory, thoracic and mediastinal disorder Common:
Danish: Luftveje, thorax og mediastinum Almindelig:
English: The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerability of the patient.
Danish: Afhængigt af det klinske respons og tolerabiliteten hos den enkelte patient, bør dosis justeres inden for det effektive doseringsinterval mellem 400 mg og 800 mg pr. dag.
English: Seroquel XR should be administered prior to bedtime.
Danish: Seroquel XL Denne indlægsseddel blev senest revideret {MM/YYYY}.
English: Coating
Danish: Vægtøgning
English: Your doctor will decide on your starting dose.
Danish: Din læge vil bestemme hvilken dosering, du skal starte med, og hvor mange Seroquel Prolong tabletter, du skal tage om dagen.
English: Syncope 4, 17
Danish: Ortostatisk hypotension4,17
English: (6) Calculation of Frequency for these ADR's have only been taken from postmarketing data with the immediate release formulation of Seroquel (7) Fasting blood glucose ≥126mg/dL(≥7.0 mmol/L) or a non fasting blood glucose ≥200mg/dL (≥11.1 mmol/L) on at least one occasion (8) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression (9) Based on >7% increase in body weight from baseline.
Danish: (7) Mindst ét tilfælde af fastende blodglukose ≥126 mg/dl (≥7,0 mmol/l) eller ikke fastende blodglukose ≥200 mg/dl (≥11,1 mmol/l).
English: • Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
Danish: • Overfølsomhedsreaktioner med f.eks hævelse af hals, ansigt og læber.
English: Seroquel XR 50 mg tablets are peach-coloured and engraved with “XR 50” on one side Seroquel XR 150 mg tablets are white and engraved with “XR 150” on one side Seroquel XR 200 mg tablets are yellow and engraved with “XR 200” on one side Seroquel XR 300 mg tablets are pale yellow and engraved with “XR 300” on one side Seroquel XR 400 mg tablets are white and engraved with “XR 400” on one side
Danish: Seroquel Prolong 50 mg tabletter er ferskenfarvede og præget med ”XR 50” på den ene side.
English: General disorders and administration site conditions Very common Withdrawal (discontinuation) symptoms 1, 10
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: This may make you feel dizzy or faint (may lead to falls).
Danish: • Fald i blodtryk når du rejser dig op. Du kan føle dig svimmel eller besvime (kan medføre fald).
English: Dysphagia (See section 4.8 Undesirable effects) has been reported with quetiapine.
Danish: Der er rapporteret dysfagi med quetiapin (se pkt.
English: The available evidence from placebo-controlled clinical trials with Seroquel is presented in sections 4.4, 4.8, 5.1 and 5.2..
Danish: De forhåndenværende beviser fra placebo-kontrollerede kliniske forsøg med Seroquel er anført i pkt.
English: IS - Iceland AstraZeneca A/S Roskildevej 22
Danish: AstraZeneca A/S, Albertslund, Danmark 12.
English: The absolute bioavailability is 88%.
Danish: Den absolutte biotilgængelighed er 88 %.
English: These occurrences were generally self-limiting and of short duration.
Danish: Disse tilfælde var generelt selvbegrænsende og kortvarige.
English: Only negative animals should be treated.
Danish: Kun negative dyr skal behandles.
English: ATC vet code: QP54AB51.
Danish: ATCvet-kode: QP54AB51.
English: To establish a treatment routine, it is recommended that the same day or date be used each month.
Danish: For at etablere en behandlingsrutine anbefales det at behandle samme dag eller dato i hver måned.
English: Date of first authorisation: 15/01/2015 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 15/01/2015 Dato for seneste fornyelse af markedsføringstilladelse:
English: The terminal plasma half-life is approximately 2 weeks in dogs.
Danish: Terminal plasmahalveringstid er ca. 2 uger hos hund.
English: The systemic absorption of afoxolaner is high.
Danish: Den systemiske absorption af afoxolaner er høj.
English: The veterinary medicinal product should be administered in accordance with the following table:
Danish: Det veterinærmedicinske lægemiddel skal indgives i henhold til følgende tabel:
English: No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.
Danish: Der blev ikke observeret bivirkninger hos raske, otte uger gamle hvalpe efter 6 behandlinger med op til 5 gange den maksimale dosis.
English: The recommended dose should be strictly observed in collies or related breeds.
Danish: Den anbefalede dosis bør overholdes nøje for collier eller beslægtede racer.
English: - This product may cause gastrointestinal disturbances if ingested.
Danish: - Præparatet kan forårsage gastrointestinale forstyrrelser, hvis det indtages.
English: The absolute bioavailability is 81% and 65% for the A3 and A4 forms, respectively.
Danish: Den absolutte biotilgængelighed er hhv. 81 % og 65 % for A3 og A4 formen.
English: For dogs above 60 kg appropriate combinations of chewable tablets should be used.
Danish: Til hunde, som vejer over 60 kg, skal der anvendes en passende kombination af tyggetabletter.
English: Further treatments may be indicated throughout the flea and/or tick season.
Danish: Yderligere behandling kan være nødvendig igennem hele loppe- og/eller flåtsæsonen.
English: To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment.
Danish: For at minimere risikoen for resistensudvikling anbefales det, at hunde undersøges for både cirkulerende antigener og for mikrofilarier i blodet ved sæsonstart for forebyggende behandling.
English: Post-marketing safety experience
Danish: Sikkerhedserfaringer efter markedsføring
English: Bodyweight (kg) of dog
Danish: Hundens kropsvægt (kg)
English: This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.
Danish: Dette fører til hyperpolarisering af neuromuskulærmembranen med deraf følgende paralyse og død hos parasitterne.
English: It is a fermentation product of Streptomyces milbemycinicus.
Danish: Det er et fermentationsprodukt fra Streptomyces milbemycinicus.
English: Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.
Danish: Det kan være nødvendigt at give yderligere månedlige behandlinger baseret på klinisk vurdering og hudskrab.
English: Special warnings for each species:
Danish: Særlige advarsler for hver dyreart:
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-riskforholdet.
English: Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
Danish: Samtidig behandling med andre P-gp substrater kan derfor føre til forøget giftighed.
English: As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Danish: Da demodecose er en multi-faktuel sygdom, anbefales det at behandle underliggende sygdom på passende måde, hvor det er muligt.
English: Each chewable tablet contains the active substances:
Danish: En tyggetablet indeholder følgende aktive stoffer:
English: Milbemycin oxime contains two major components, A3 and A4 (ratio of 20:80 for A3:A4).
Danish: Milbemycinoxim indeholder to hovedkomponenter, A3 og A4 (i forholdet 20:80 for A3: A4).
English: Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class.
Danish: Resistens hos parasitter kan udvikles over for enhver klasse af antiparasitære lægemidler ved hyppig anvendelse af et stof fra samme klasse.
English: NEXGARD SPECTRA is not indicated for removal of microfilariae from positive dogs.
Danish: NEXGARD SPECTRA er ikke beregnet til udryddelse af mikrofilarier fra positive hunde.
English: - In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld, især til børn, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Danish: Da der ikke foreligger data, skal behandling af hvalpe yngre end 8 uger og hunde, som vejer under 2 kg, baseres på den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
English: The mean maximum concentration (Cmax) is 1822 ± 165 ng/ml in plasma found 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Danish: Middel maksimal koncentration (Cmax) er 1822 ± 165 ng/ml i plasma påvist 2-4 timer (Tmax) efter en dosis på 2,5 mg/kg afoxolaner.
English: Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Danish: Isoxazoliner, blandt chloridkanalmodulatorerne, bindes til et bestemt og unikt område i insektets GABACl , hvorved de blokerer den præ- og postsynaptiske overførsel af chloridioner over cellemembraner.
English: Milbemycin oxime is a substrate for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Danish: Milbemycinoxim er et substrat for P-glycoprotein (P-gp) og kan derfor interagere med andre P-gp substrater (for eksempel digoxin og doxorubicin) eller andre makrocykliske laktoner.
English: Each chewable tablet contains:
Danish: En tablet indeholder:
English: Milbemycin oxime plasma concentrations peak quickly within the first 1-2 hours (Tmax) indicating that absorption from the chewable tablets is fast.
Danish: Maksimal milbemycinoxim plasmakoncentrationer nås hurtigt inden for de første 1-2 timer (Tmax), hvilket indikerer at absorptionen fra tyggetabletterne er hurtig.
English: The treatment schedule should be based on veterinary diagnosis and on the local epidemiological situation.
Danish: Behandlingsinterval: Behandlingsintervallet skal baseres på dyrlægens diagnose og på den lokale epidemiologiske status.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control.
Danish: Opretholdelse af de makrocykliske laktoners virkning er afgørende for at kunne kontrollere Dirofilaria immitis.
English: NEXGARD SPECTRA is not indicated for microfilariae clearance.
Danish: NEXGARD SPECTRA er ikke indiceret til udryddelse af mikrofilarier.
English: The veterinary medicinal product should be administered at a dose of 2.50-5.36 mg/kg of afoxolaner and 0.50-1.07 mg/kg of milbemycin oxime in accordance with the following table:
Danish: Det veterinærmedicinske lægemiddel skal administreres i en dosis på 2,50-5,36 mg/kg afoxolaner og 0,50-1,07 mg/kg milbemycinoxim i henhold til følgende tabel:
English: No therapeutic effect against adult Dirofilaria immitis has been established.
Danish: Der er ikke påvist nogen terapeutisk virkning mod voksne Dirofilaria immitis.
English: Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations.
Danish: Farmakoterapeutisk gruppe: antiparasitære midler, endektocider, milbemycinkombinationer.
English: The terminal half-lives and maximum concentrations (Cmax) following oral administration are 1.6 ± 0.4 days and 42 ± 11 ng/ml for the A3 form, 3.3 ± 1.4 days and 246 ±71 ng/ml for the A4 form.
Danish: Terminale halveringstider og maksimale koncentrationer (Cmax) efter oral administration er 1,6 ± 0,4 dage og 42 ± 11 ng/ml for A3 formen, 3,3 ± 1,4 dage og 246 ± 71 ng/ml for A4 formen.
English: Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines.
Danish: Langvarig afoxolanerinduceret hypereksitation resulterer i en ukontrolleret aktivitet i centralnervesystemet med deraf følgende drab af insekter og mider.
English: For oral use.
Danish: Til oral administration.
English: Both forms have low systemic clearance (75 ± 22 ml/h/kg for the A3 form and 41 ± 12 ml/h/kg for the A4 form).
Danish: Begge former har lav systemisk clearance (75 ± 22 ml/t/kg for A3 formen og 41 ± 12 ml/t/kg for A4 formen).
English: When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered.
Danish: Når det erstatter et andet præparat til forebyggelse af hjerteorm, bør første behandling med NEXGARD SPECTRA starte på den dato, hvor det tidligere præparat skulle have været givet.
English: Ask your veterinarian how to continue flea and tick treatment.
Danish: Spørg dyrlægen til råds om fortsat loppe- og flåtbehandling.
English: Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
Danish: Afoxolaner virker som en antagonist på ligand-styrede chloridkanaler, især de der styres af neurotransmitteren gamma-aminosmørsyre (GABA).
English: Treatment should continue until 1 month after the last exposure to mosquitoes.
Danish: Behandlingen bør fortsætte i en måned efter sidste myggeeksponering.
English: At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Danish: Baseret på dyrlægens skøn bør infesterede hunde behandles med et adulticid til at udrydde voksne hjerteorm.
English: If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ualmindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination.
Danish: Afoxolaner dræber lopper før ægproduktion og forebygger derfor smittespredning til omgivelserne.
English: Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Danish: Derfor bør anvendelsen af dette præparat baseres på en individuel vurdering af hvert enkelt tilfælde samt på lokale epidemiologiske informationer om målarternes aktuelle følsomhed for at begrænse sandsynligheden for fremtidig resistensudvikling.
English: Chewable tablets Read the package leaflet before use.
Danish: Tyggetabletter Læs indlægssedlen inden brug.
English: Therefore, the product should be administered at regular monthly intervals during the time of the year when mosquitoes are present, starting in the month after the first expected exposure to them.
Danish: Derfor skal præparatet anvendes med regelmæssige månedlige intervaller i den periode, hvor vektorerne er til stede, med opstart inden for en måned efter første forventede myggeeksponering.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: - This product may cause gastrointestinal disturbances if ingested.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Præparatet kan forårsage forstyrrelser i mave-tarmkanalen, hvis det indtages.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell.
Danish: Milbemycinoxim øger glutamatbindingen med efterfølgende øget indstrømning af chloridioner i cellen.
English: Manufacturer responsible for batch release: MERIAL,
Danish: Fremstiller ansvarlig for batchfrigivelse: MERIAL
English: Vomiting, diarrhoea, lack of energy, decreased appetite and itching were uncommonly observed.
Danish: Opkastninger, diarré, sløvhed, manglende appetit og kløe blev set, men var ualmindelige.
English: It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Det kan indgå som led i behandlingen af loppebetinget allergisk dermatitis (FAD).
English: One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Danish: 1 æske indeholder ét blister à 1, 3 eller 6 tyggetabletter eller 15 blistre à 1 tyggetablet.
English: 1 chewable tablet 3 chewable tablets 6 chewable tablets 15 chewable tablets
Danish: 1 tyggetabletter 3 tyggetabletter 6 tyggetabletter 15 tyggetabletter
English: Ancylostoma ceylanicum is reported as being endemic only in Southeast Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Danish: Ancylostoma ceylanicum er kun rapporteret som værende endemisk i Sydøstasien, Kina, Indien, Japan, visse stillehavsøer, Australien, Den Arabiske Halvø, Sydafrika samt Sydamerika.
English: Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/h/kg.
Danish: Afoxolaner fordeles til væv med et fordelingsvolumen på 2,6 ± 0,6 l/kg og en systemisk clearance på 5,0 ± 1,2 ml/t/kg.
English: Milbemycin oxime:
Danish: Milbemycinoxim:
English: The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.
Danish: Afoxolaners selektive toksicitet over for insekter og mider i forhold til pattedyr kan skyldes forskel i GABA-receptorernes følsomhed hos insekter og mider i forhold til pattedyrs receptorer.
English: NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes.
Danish: NEXGARD SPECTRA dræber Dirofilaria immitis larver (hjerteorm) i op til en måned efter at de er overført fra myg.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity in males and females.
Danish: Laboratoriestudier af rotter og kaniner har ikke afsløret teratogene virkninger eller nogen bivirkninger på reproduktionsevnen hos hanner og hunner.
English: Efficacy of the treatment against flea and tick infestations lasts for one month.
Danish: En behandling mod angreb af lopper og flåter er virksom i en måned.
English: Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Danish: Afoxolaner er et insekticid og acaricid, som hører til isoxazolinfamilien.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones.
Danish: Milbemycinoxim er et antiparasitært endectocid, som hører til gruppen af makrocykliske laktoner.
English: It is therefore recommended that all dogs 8 months of age or more, living in heartworm endemic areas, should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.
Danish: Det anbefales derfor, at alle hunde som er 8 måneder gamle eller ældre, som lever i områder med endemisk hjerteorm, testes for eksisterende infestation med hjerteorm, før de behandles med præparatet til forebyggelse af hjerteorm.
English: Dogs living in heartworm endemic areas, or those which have travelled to endemic areas, may be infested with adult heartworms.
Danish: Hunde fra områder med endemisk hjerteorm, eller som har rejst til endemiske områder, kan blive smittet med voksne hjerteorm.
English: Vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed.
Danish: Opkastninger, diarré, letargi, anorexi og pruritus var ualmindelige.