FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects e Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, and drug eruption and pemphigoid.
Danish: Bivirkninger e Hududslæt er en sammensat term, der inkluderer makulopapuløst udslæt, erytematøst udslæt, kløende udslæt, follikulært udslæt, makuløst udslæt, morbilliformt udslæt, papuløst udslæt, pustuløst udslæt, papuloskvamøst udslæt, vesikuløst udslæt, generaliseret udslæt, dermatitis, acneiform dermatitis, allergisk dermatitis, atopisk dermatitis, bulløs dermatitis, eksfoliativ dermatitis, psoriasiform dermatitis, medikamentelt udslæt og pemfigoid.
English: Nivolumab - Pemphigoid (EPITT no 18759)
Danish: Nivolumab - Pemfigoid (EPITT nr. 18759)
English: Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dose in the first trimester, show no increased risk of undesirable effects in the foetus.
Danish: Data fra flere hundrede gravide kvinder behandlet med standard dosis (<200 mg / dag) fluconazol, administreret som en enkelt eller gentagne doser, i første trimester viser ingen øget risiko for uønsket fosterpåvirkning.
English: There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis.
Danish: Der har været rapporter om multiple medfødte abnormiteter (herunder brakycefali, øredysplasi, stor forreste fontanelle, femoral bøjning og radio-humeral synostose) hos spædbørn, hvis mødre var blevet behandlet i tre eller flere måneder med høje doser (400-800 mg dagligt) fluconazol mod kokcidioidomykose.
English: Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary.
Danish: Fluconazol i standarddoser og kortvarige behandlinger bør ikke anvendes under graviditet, medmindre det vurderes klart nødvendigt.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/68687/2017
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/113478/2017
English: Fluconazole in high dose and/or in prolonged regimens should not be used during pregnancy except for potentially life-threatening infections.
Danish: Fluconazol i høje doser og/eller i længerevarende behandlingsforløb bør ikke anvendes under graviditet, undtagen ved potentielt livstruende infektioner.
English: Fluconazole - Spontaneous abortion and stillbirth (EPITT no 18666)
Danish: Fluconazol - Spontane aborter og dødfødsler (EPITT nr.
English: 4 - Possible side effects Skin rash sometimes with blisters, itching
Danish: Hududslæt, undertiden med blærer, kløe
English: Water may be given.
Danish: Der kan gives vand.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: Sympathetic neurotransmission is prevented and the level of consciousness decreases.
Danish: Sympatisk neurotransmission forhindres, og bevidsthedsniveauet falder.
English: Dogs: IM, IV Cats: IM
Danish: Hunde: IM, IV Katte: IM
English: The stopper may be safely punctured up to 100 times.
Danish: Proppen kan gennemstikkes sikkert op til 100 gange.
English: The eyes should be protected by a suitable eye lubricant.
Danish: Øjnene bør beskyttes med en passende øjensalve.
English: At maximal effect, the animal is relaxed, recumbent and does not respond to external stimulus.
Danish: Ved maksimal effekt er dyret roligt, ligger ned og reagerer ikke på stimulering udefra.
English: Spontaneous recovery occurs within 3 hours.
Danish: Der forekommer spontan opvågning inden for tre timer.
English: All known metabolites lack pharmacological activity.
Danish: Alle kendte metabolitter er uden farmakologisk aktivitet.
English: The following doses are recommended:
Danish: Følgende doser anbefales:
English: Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
Danish: Nervøse, aggressive eller ophidsede dyr bør have mulighed for at falde til ro, før behandlingen påbegyndes.
English: In a clinical study, the requirement for propofol was reduced by 50%.
Danish: I en klinisk undersøgelse blev behovet for propofol reduceret med 50 %.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the package after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på pakningen efter UDL.D.
English: Frequent and regular monitoring of respiratory and cardiac function should be performed.
Danish: Hyppig og regelmæssig overvågning af åndedræts- og hjertefunktion skal foretages.
English: The dose should be adjusted to the type of surgery, length of procedure and patient temperament.
Danish: Dosis bør justeres efter typen af kirurgisk indgreb, procedurens længde samt patientens temperament.
English: Vomiting may occur 5-10 minutes after injection.
Danish: Der kan forekomme opkastning 5-10 minutter efter injektion.
English: 1 ml contains:
Danish: 1 ml indeholder:
English: However this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.
Danish: Varigheden er dog afhængig af en række variabler, og yderligere analgesi bør administreres efter klinisk skøn.
English: The corresponding doses based on body weight are presented in the following tables.
Danish: Doseringer baseret på legemsvægt angives i de følgende tabeller.
English: Pulse oximetry may be useful but is not essential for adequate monitoring.
Danish: Pulsoximetri kan være nyttig, men er ikke nødvendig for tilstrækkelig overvågning.
English: To be used with precaution in elderly animals.
Danish: Bør anvendes med forsigtighed hos ældre dyr.
English: Within 15 minutes dogs and cats are normally awake and standing.
Danish: I løbet af 15 minutter er hunden eller katten sædvanligvis vågen og står op.
English: The veterinary medicinal product is intended for:
Danish: Veterinærlægemidlet er beregnet til:
English: In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively.
Danish: I en klinisk undersøgelse blev behovet for propofol og tiopental reduceret med henholdsvis 30 % og 60 %.
English: According to studies in rats, the maximum concentration in the central nervous system is several times that of the corresponding concentration in plasma.
Danish: Ifølge forsøg med rotter er maksimumkoncentrationen i centralnervesystemet mange gange det, der svarer til den tilsvarende koncentration i plasma.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN ”KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: <{MM/YYYY}>
Danish: <{MM/ÅÅÅÅ}>
English: For deep sedation and analgesia with butorphanol
Danish: Til dyb sedation og analgesi med butorphanol
English: In some dogs and cats, a decrease in respiratory rate may occur.
Danish: Hos nogle hunde og katte kan der forekomme en nedsættelse af respirationsfrekvensen.
English: Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.
Danish: Det anbefales at benytte en sprøjte med passende skalering for at sikre korrekt dosering ved administrering af små mængder.
English: Metabolites are excreted mainly in the urine (51% of the dose), and to a lesser extent in the faeces.
Danish: Metabolitterne udskilles for det meste i urinen (51 % af dosen) og i mindre grad i afføringen.
English: In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 - 4 hours.
Danish: I en klinisk undersøgelse bevirkede dexmedetomidin postoperativ analgesi i 0,5-4 timer.
English: Dexmedetomidine is also rapidly distributed in the body and penetrates the blood-brain barrier readily.
Danish: Dexmedetomidin distribueres også hurtigt i kroppen og penetrerer let blodhjernebarrieren.
English: Biotransformations in the cat occur by hydroxylation in the liver.
Danish: Biotransformation hos kat sker ved hydroxylering i leveren.
English: Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives ATCvet code: QN05CM18
Danish: Farmakoterapeutisk gruppe: psykoleptika, hypnotika og sedativa ATCvet-kode: QN05CM18.
English: All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect.
Danish: Alle anæstesimidler, der benyttes til induktion eller vedligeholdelse af anæstesi, bør administreres til effekt.
English: Ventricular arrhythmias have also been reported.
Danish: Ventrikulære arytmier er også rapporteret.
English: Cepedex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Danish: Cepedex indeholder dexmedetomidin som det aktive stof, der frembringer sedation og analgesi hos hunde og katte.
English: Respiration rate can occasionally decrease.
Danish: Respirationsfrekvensen kan lejlighedsvis blive nedsat.
English: It is recommended that animals are fasted for 12 hours prior to Cepedex administration.
Danish: Det anbefales, at dyret bliver fastet i 12 timer inden anvendelsen af Cepedex.
English: The elimination half-life (t1⁄2) is 40-50 minutes.
Danish: Halveringstiden (t½) for elimination er 40-50 minutter.
English: Do not use in animals with cardiovascular disorders.
Danish: Bør ikke anvendes til dyr med kardiovaskulære lidelser.
English: The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
Danish: Den maksimale plasmakoncentration nås ca. 0,24 t. efter intramuskulær administration.
English: Dexmedetomidine is a potent and selective α2-adrenoceptor agonist that inhibits the release of noradrenaline from noradrenergic neurons.
Danish: Dexmedetomidin er en potent og selektiv α2-adrenoceptor-agonist, som hæmmer frigivelsen af noradrenalin fra noradrenerge neuroner.
English: The veterinary medicinal product is not intended for repeat injections.
Danish: Veterinærlægemidlet er ikke beregnet til gentagne injektioner.
English: The duration and depth of the sedation and analgesia are dose-dependent.
Danish: Varigheden og dybden af sedationen og analgesien er dosis afhængig.
English: By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.
Danish: På grund af dets α2-adrenerge aktivitet forårsager dexmedetomidin en nedsættelse af hjertefrekvens og legemstemperatur.
English: Atipamezole does not reverse the effect of ketamine.
Danish: Atipamezol ophæver ikke virkningen af ketamin.
English: Respiratory and haemodynamic symptoms should be treated symptomatically.
Danish: Respiratoriske og hæmodynamiske symptomer skal behandles symptomatisk.
English: Metabolites are excreted mainly in the urine and to a lesser extent in the faeces.
Danish: Metabolitterne udskilles hovedsagelig i urinen og i mindre grad i afføringen.
English: After treatment, the animal should not be given water or food before it is able to swallow.
Danish: Efter behandlingen bør dyret ikke tilbydes vand eller foder, før det er i stand til at synke.
English: Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
Danish: Behandlede dyr skal under proceduren og opvågningen holdes varme og ved konstant temperatur.
English: When dexmedetomidine is used for premedication in cats, the same dose is used.
Danish: Når dexmedetomidin bruges til præmedicinering hos katte, anvendes den samme dosis.
English: The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg.
Danish: Biotilgængeligheden af dexmedetomidin er 60 %, og fordelingsvolumen (Vd) er 0,9 l/kg.
English: Cat Weight
Danish: Katte Vægt
English: Vomiting, hypothermia and nervousness have been reported after such use.
Danish: Der er rapporteret tilfælde af opkastning, hypotermi og nervøsitet efter brugen af disse medikamenter.
English: (equivalent to dexmedetomidine
Danish: (svarende til dexmedetomidin
English: Attention should be given during the administration of intravenous induction medicinal products to effect.
Danish: Der bør udvises særlig opmærksomhed under indgivelse af intravenøs induktionsmedicin til effekt.
English: Some dogs and cats may also vomit at the time of recovery.
Danish: Nogle hunde og katte kan også kaste op ved opvågning.
English: *only IM
Danish: *kun IM
English: Overdose (symptoms, emergency procedures, antidotes) Dogs:
Danish: Overdosering (symptomer, nødforanstaltninger, modgift):
English: Disposal: read package leaflet.
Danish: Vedrørende bortskaffelse: Læs indlægssedlen.
English: The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
Danish: Den gennemsnitlige eliminationshalveringstid for dexmedetomidin blev forøget til 1,6 t., og den totale eksponering (AUC) steg med 50 %.
English: Sodium hydroxide (E 524) (for pH adjustment) Hydrochloric acid (E507) (for pH adjustment) Water for injections
Danish: Natriumhydroxid (E524) (til pH-justering) Saltsyre (E507) (til pH-justering) Vand til injektionsvæsker
English: In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin.
Danish: I tilfælde af hud- eller slimhindekontakt skal det berørte område straks vaskes med rigeligt vand, og forurenet beklædning med kontakt til huden skal fjernes.
English: A slight decrease in temperature may be observed.
Danish: Der kan forekomme et mindre temperaturfald.
English: It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Danish: Det anbefales også at have oxygen til rådighed, hvis der skulle være tegn på eller mistanke om hypoxæmi.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler i forbindelse med opbevaring.
English: Anticholinergics should be used with caution with dexmedetomidine.
Danish: Antikolinerge midler bør anvendes med forsigtighed sammen med dexmedetomidin.
English: The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
Danish: Brugen af andre centralnervesystemsedativer kan forventes at forstærke virkningerne af dexmedetomidin, og der bør derfor foretages en passende justering af dosen.
English: Brady- and tachyarrhythmias have been reported.
Danish: Der er blevet rapporteret brady- og takyarytmi.
English: Therefore the use of the product during pregnancy and lactation is not recommended.
Danish: Derfor frarådes brug af produktet under drægtighed og laktation.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: In the circulation, dexmedetomidine is largely bound to plasma proteins (>90%).
Danish: I kredsløbet binder dexmedetomidin sig for det meste til hundens og kattens plasmaproteiner (>90 %).
English: Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/or with a blue tinge.
Danish: På grund af perifer vasokonstriktion og venøs desaturation i forbindelse med normal arteriel iltning kan der ses et blegt og/eller blåligt skær på slimhinderne.
English: Dexmedetomidine also induces a number of other α2-adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Danish: Dexmedetomidin inducerer ligeledes en række andre α2-adrenoceptor-medierede virkninger, der omfatter hårrejsning, depression af motoriske og sekretoriske funktioner i gastrointestinalkanalen, diurese og hyperglykæmi.
English: Shelf life of the veterinary medicinal product as packaged for sale: 4 years Shelf-life after first opening the immediate packaging: 56 days.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 4 år Holdbarhed efter første åbning af den inderste emballage: 56 dage.
English: Do not use in animals with severe systemic disease or in animals that are moribund.
Danish: Bør ikke anvendes til dyr, som lider af alvorlige systemiske lidelser eller er døende.
English: Methyl parahydroxybenzoate (E 218)
Danish: Methylparahydroxybenzoat (E 218)
English: Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Danish: De volatile anæstesikrav til vedligeholdelse af anæstesien reduceres også.
English: The specific α2-adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Danish: Den specifikke α2-adrenoceptor-antagonist, atipamezol, som er godkendt til brug hos dyr, er kun blevet anvendt eksperimentelt hos mennesker til at ophæve virkningen af dexmedetomidin-inducerede virkninger.
English: The veterinary medicinal product is intended for: - Dogs: intravenous or intramuscular use - Cats: intramuscular use
Danish: Veterinærlægemidlet er beregnet til: - Hunde: intravenøs eller intramuskulær anvendelse - Katte: intramuskulær anvendelse
English: Corneal opacities may occur during sedation (see also the section on Special precautions for the use in animals).
Danish: Der kan forekomme cornea-uklarhed under sedationen (se også punktet Særlige forsigtighedsregler vedrørende brug til dyr).
English: Blood pressure will increase initially and then return to normal or below normal.
Danish: Blodtrykket vil først stige og derefter vende tilbage til det normale eller lidt under det normale.
English: Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes.
Danish: Sedationen varer mindst 120 minutter efter indgivelse, analgesien i mindst 90 minutter.
English: Dog Weight
Danish: Hunde Vægt
English: Date of first authorisation:13/12/2016 <Date of last renewal:> <{DD/MM/YYYY}> <{DD month YYYY}.>
Danish: Dato for første markedsføringstilladelse:13/12/2016.
English: Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and Nmethylation in the liver.
Danish: Væsentlige biotransformationer hos hunde inkluderer hydroxylering, konjugering med glukoronsyre og N-methylering i leveren.
English: Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.
Danish: Dyb sedation og analgesi hos hunde i kombination med butorphanol til kliniske undersøgelser og mindre kirurgiske indgreb.
English: When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.
Danish: Ved indgivelse sammen med butorphanol (0,1 mg/kg) til dyb sedation og analgesi, er den intramuskulære dosis af dexmedetomidin 300 mikrogram pr. kvadratmeter legemsoverflade.
English: If symptoms occur, seek the advice of a physician.
Danish: Søg råd hos en læge, hvis der opstår symptomer.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Danish: Kontakt dyrlægen eller apotekspersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: Dosing for cats is presented in the following table.
Danish: Doseringen for katte angives i tabellen nedenfor.
English: The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration.
Danish: De forventede sedative og analgesiske virkninger opnås inden for 15 minutter efter indgivelse og varer i op til 60 minutter efter indgivelse.
English: For non-invasive, mildly to moderately painful procedures and examinations requiring restraint, sedation and analgesia:
Danish: Til ikke-invasive, let til moderat smertefulde procedurer og undersøgelser, der kræver fiksering, bedøvelse og analgesi.
English: Muscle tremors may occur during sedation.
Danish: Der kan forekomme muskulære trækninger under sedationen.
English: Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Danish: Præmedicinering af hunde og katte inden påbegyndelse og vedligeholdelse af generel anæstesi.
English: Dogs: Dexmedetomidine doses are based on body surface area:
Danish: Hunde: Dexmedetomidindoser til hunde er baseret på deres legemsoverflade:
English: Cats: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 ng/ml.
Danish: Katte: Efter en 40 mikrogram/kg legemsvægt intramuskulær dosis er Cmax 17 ng/ml.
English: Atipamezole should not be administered prior to 30 minutes following ketamine administration.
Danish: Atipamezol bør ikke gives før 30 minutter efter administration af ketamin.
English: Dogs: intravenous or intramuscular use Cats: intramuscular use Read the package leaflet before use.
Danish: Hunde: intravenøs eller intramuskulær anvendelse Katte: intramuskulær anvendelse Læs indlægssedlen inden brug.
English: Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.
Danish: Til ikke invasive, svagt til moderat smertefulde procedurer og undersøgelser, der kræver fiksering, sedation og analgesi af hunde og katte.
English: The premedication dose of dexmedetomidine is 125 - 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Danish: Dosis af dexmedetomidin ved præmedicinering er 125-375 mikrogram pr. kvadratmeter legemsoverflade, som indgives 20 minutter inden induktion ved anæstesikrævende procedurer.
English: (mcg/kg)
Danish: (µg/kg)
English: The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination half-life (t1⁄2) is one hour.
Danish: Fordelingsvolumet (Vd) er 2,2 l/kg, og eliminationshalveringstiden (t½) er en time.
English: Dexmedetomidine has a high clearance and its elimination depends on the hepatic blood flow.
Danish: Dexmedetomidin har en høj clearance, og eliminationen afhænger af det hepatiske blodflow.
English: As in dogs dexmedetomidine has a high clearance in cats and its elimination depends on the hepatic blood flow.
Danish: Som hos hunde har dexmedetomidin en høj clearance hos katte, og eliminationen afhænger af det hepatiske blodflow.
English: Interactions with other medicinal products and other forms of interaction The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
Danish: Interaktioner med andre lægemidler og andre former for interaktion Anvendelse af andre midler, der dæmper centralnervesystemet, forventes at forstærke virkningerne af dexmedetomidin, hvorfor dosis bør justeres derefter.
English: The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.
Danish: Administration af dexmedetomidin til hvalpe under 16 uger og killinger under 12 uger er ikke undersøgt.
English: Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.
Danish: Syge og svækkede hunde og katte skal kun præmedicineres med dexmedetomidin før påbegyndelse og vedligeholdelse af generel bedøvelse, baseret på en vurdering af risici og fordele.