FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking the activity of EGF receptors, the cancer cells no longer receive the messages needed for growth and multiplication.
Danish: Når EGFreceptorernes aktivitet blokeres, modtager kræftcellerne ikke længere de signaler, der får dem til at vokse og dele sig.
English: For practical information about using Caprelsa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Caprelsa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Caprelsa used?
Danish: Hvordan anvendes Caprelsa?
English: How does Caprelsa work?
Danish: Hvordan virker Caprelsa?
English: What benefits of Caprelsa have been shown in the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Caprelsa?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Caprelsa have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Caprelsa.
English: • Avoid contact by mouth.
Danish: • Undgå kontakt via munden.
English: Therefore they should be used with caution.
Danish: De bør derfor anvendes med forsigtighed.
English: Elimination from blood is largely complete within 24 hours.
Danish: Eliminationen fra blodet er i stor udstrækning komplet i løbet af 24 timer.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/035/007
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/02/035/007
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 December 2002
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 11. december 2002
English: The half-life for the slow elimination phase is approximately 50 minutes.
Danish: Halveringstiden for den langsomme eliminationsfase er ca. 50 minutter.
English: Inspired concentration:
Danish: Inspireret koncentration:
English: Appropriate treatment should readily be instituted.
Danish: Adækvat behandling bør straks iværksættes.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years 6.4 Special precautions for storage
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år 6.4 Særlige opbevaringsforhold
English: • Do not inhale the vapour directly.
Danish: • Indånd ikke dampen direkte.
English: Medical attention should be sought if irritation persists.
Danish: Der bør søges lægehjælp, hvis irritationen varer ved.
English: There are limited data to support the safety of sevoflurane in animals less than 12 weeks of age.
Danish: Der findes begrænsede data til underbygning af sevoflurans sikkerhed hos dyr under 12 uger.
English: Therefore, the lack of significant colour change should not be taken as an assurance of adequate hydration.
Danish: Mangel på betydende farveændring bør derfor ikke tages som en forsikring om en tilstrækkelig fugtighedsgrad.
English: There is no information on the adjustment of the maintenance dose in cats.
Danish: Der findes ingen oplysninger vedrørende justering af vedligeholdelsesdosis hos katte.
English: Advice to doctors: Maintain a patent airway and give symptomatic and supportive treatment.
Danish: Vejledning for læger: Oprethold frie luftveje og giv symptomatisk og understøttende behandling.
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO EXP {måneder/år}
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 almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (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: The elimination of sevoflurane is biphasic in nature, with an initial rapid phase and a second, slower phase.
Danish: Eliminationen af sevofluran har en bifasisk karakter med en initial hurtig fase og en sekundær, langsommere fase.
English: Hepatic oxygen delivery and consumption were not significantly altered at concentrations up to 2.0 MAC.
Danish: Hepatisk iltoptagelse og iltforbrug blev ikke ændret signifikant ved koncentrationer op til 2,0 MAC.
English: Active substance: Each bottle contains 250 ml sevoflurane (100%).
Danish: Aktivt stof: Hver flaske indeholder 250 ml sevofluran (100%).
English: • From an environmental point of view, it is considered good practice to use charcoal filters with scavenging equipment.
Danish: • Udfra et miljømæssigt synspunkt anses det for god praksis at anvende trækulsfiltre sammen med udsugningsudstyr.
English: Sevoflurane is metabolised to a limited extent in the dog (1 to 5%).
Danish: Sevofluran metaboliseres i begrænset omfang hos hunde (1 til 5%).
English: CO2 absorbents should be replaced routinely regardless of the state of the colour indicator.
Danish: CO2-absorberende stoffer bør udskiftes rutinemæssigt uden hensyn til farveindikatorens tilstand.
English: If it is suspected that the CO2 absorbent may be desiccated, it must be replaced.
Danish: Hvis der er mistanke om, at det CO2-absorberende stof kan være udtørret, bør det udskiftes.
English: If these symptoms occur, the individual should be removed from the source of exposure and medical attention sought.
Danish: Hvis disse symptomer forekommer, skal personen fjernes fra eksponeringskilden og der skal søges lægehjælp.
English: Date of last renewal: 6 November 2007
Danish: Dato for seneste fornyelse: 06/11/2007
English: Multiples of MAC are used as a guide for surgical levels of anaesthesia, which are typically 1.3 to 1.5 times the MAC value.
Danish: Multipla af MAC-værdien bruges som vejledning for kirurgisk anæstesiniveau, som typisk er 1,3 til 1,5 gange MAC-værdien.
English: SevoFlo overdose may result in profound respiratory depression.
Danish: Overdosering af SevoFlo kan resultere i dyb respirationsdepression.
English: Benzodiazepines and opioids:
Danish: Benzodiazepiner og opioider:
English: 1,1,3,3,3-pentafluoro-2-(fluoromethoxy)propene (C4H2F6O), also known as Compound A, is produced when sevoflurane interacts with soda lime or barium hydroxide.
Danish: 1,1,3,3,3-pentafluoro-2-(fluoromethoxy)propene (C4H2F6O), også kendt som Compound A, produceres, når sevofluran reagerer med natronkalk eller bariumhydroxid.
English: Reaction with barium hydroxide results in a greater production of Compound A than does the reaction with soda lime.
Danish: Reaktionen med bariumhydroxid resulterer i en større produktion af Compound A end reaktionen med natronkalk.
English: Direct exposure to eyes may result in mild irritation.
Danish: Direkte kontakt med øjnene kan resultere i let irritation.
English: It may be reversed by administration of anticholinergics.
Danish: Det kan reverseres ved administration af antikolinergika.
English: Although Compound A is a dose-dependent nephrotoxin in rats, the mechanism of this renal toxicity is unknown.
Danish: Selvom Compound A hos rotter er nyretoksisk afhængigt af dosis, er mekanismen ved denne nyretoksicitet ukendt.
English: STATEMENT OF ACTIVE SUBSTANCES 100% sevoflurane
Danish: ANGIVELSE AF AKTIVE STOFFER 100% sevofluran
English: Therefore, respiration must be monitored closely and supported when necessary with supplementary oxygen and/or assisted ventilation.
Danish: Respirationen skal derfor monitoreres tæt og skal om nødvendigt understøttes med ekstra ilt og/eller assisteret ventilation.
English: Interaction with other veterinary medicinal products and other forms of interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion
English: The elimination time from adipose tissue is more prolonged than from the brain.
Danish: Eliminationstiden fra fedtvæv er mere langvarig end fra hjernen.
English: No other metabolic pathways for sevoflurane have been identified.
Danish: Der er ikke fundet andre metaboliske veje for sevofluran.
English: The Minimum Alveolar Concentration (MAC) of sevoflurane in dogs is 2.36% and the MAC in cats 3.1%.
Danish: Den Mindste Alveolære Koncentration (MAC) for sevofluran er hos hunde 2,36% og MAC er 3,1% hos katte.
English: Sevoflurane produces unconsciousness by its action on the central nervous system.
Danish: Sevofluran fremkalder bevidstløshed ved sin virkning på centralnervesystemet.
English: In case of accidental contact with the skin, wash affected area with abundant water.
Danish: I tilfælde af utilsigtet kontakt med huden vaskes det afficerede område med rigelige mængder vand.
English: The colour indicator of most CO2 absorbents does not necessarily change as a result of desiccation.
Danish: Farveindikatoren i de fleste CO2-absorberende stoffer skifter ikke nødvendigvis som et resultat af udtørring.
English: This is an idiosyncratic response very occasionally seen after repeated exposure.
Danish: Dette er en idiosynkratisk reaktion, der efter gentagen udsættelse for stofferne ses meget sjældent.
English: The principle metabolites are hexafluoroisopropanol (HFIP) with release of inorganic fluoride and CO2.
Danish: Hovedmetabolitterne er hexafluoroisopropanol (HFIP) med frigørelse af uorganisk fluorid og CO2.
English: • Pregnant and breast-feeding women should not have any contact with the product and should avoid operating rooms and animal recovery areas.
Danish: • Gravide og ammende kvinder bør ikke have nogen som helst kontakt med produktet og bør undgå operationsstuer og dyrenes opvågningsområder.
English: • All scavenging/extraction systems must be adequately maintained.
Danish: • Alle udsugningssystemer skal vedligeholdes på en hensigtsmæssig måde.
English: Phenothiazines and alpha-2-agonists:
Danish: Fentiaziner og alfa-2- agonister:
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code: QN 01AB08
Danish: Farmakoterapeutisk gruppe: Inhalationsanæstetikum ATCvet-kode: QN 01 AB 08
English: Alpha-2-agonists cause bradycardia which may occur when they are used with sevoflurane.
Danish: Alfa2-agonister forårsager bradykardi, som kan forekomme, når de anvendes sammen med sevofluran.
English: The low solubility of sevoflurane also facilitates rapid elimination by the lungs.
Danish: Sevoflurans lave opløselighed fremmer også en hurtig elimination gennem lungerne.
English: • Ensure that operating rooms and animal recovery areas are provided with adequate ventilation or scavenging systems to prevent the accumulation of anaesthetic vapour.
Danish: • Man skal sikre, at operationsstuerne og dyrenes opvågningsområder er forsynet med tilstrækkelig ventilation eller udsugningssystemer for at forhindre ophobning af anæstesigas.
English: In humans sevoflurane increases both the intensity and duration of neuromuscular blockade induced by nondepolarising muscle relaxants.
Danish: Hos mennesker øger sevofluran både intensiteten og varigheden af den neuromuskulære blokade fremkaldt af non-depolariserende muskelrelaksantia.
English: Adjustment is, therefore, left to the discretion of the veterinarian.
Danish: Justering er derfor overladt til dyrlægens skøn.
English: However, it is recommended that such animals be monitored carefully during sevoflurane anaesthesia.
Danish: Det anbefales dog, at sådanne dyr monitoreres omhyggeligt under sevoflurananæstesi.
English: The pharmacokinetics of sevoflurane have not been investigated in the cat.
Danish: Sevoflurans farmakokinetik er ikke undersøgt hos katte.
English: Neuromuscular blocking agents have been used in cats anaesthetised with sevoflurane without any unexpected effects.
Danish: Neuromuskulære blokkere er blevet brugt til katte, som var anæsteseret med sevofluran, uden uventede virkninger.
English: Sevoflurane concentration for induction may be set initially, or may be achieved gradually over the course of 1 to 2 minutes.
Danish: Sevoflurankoncentration til induktion kan indstilles ved starten eller de kan indstilles gradvis i løbet af 1 til 2 minutter.
English: Limited clinical experience in administering sevoflurane to animals with renal, hepatic and cardiovascular insufficiency suggests that sevoflurane may be safely used in these conditions.
Danish: Den begrænsede kliniske erfaring med at give sevofluran til dyr med nyre-, lever- og kardiovaskulær insufficiens tyder på, at sevofluran med sikkerhed kan bruges ved disse tilstande.
English: Its concentration in a circle absorber system increases with increasing sevoflurane concentrations and with decreasing fresh gas flow rates.
Danish: Koncentrationen i et cirkelsystem med absorber stiger med stigende koncentrationer af sevofluran og med faldende friskgas flow.
English: Use only according to the risk/benefit assessment of the responsible veterinarian.
Danish: Produktet må kun anvendes i henhold til den ansvarlige dyrlæges risiko-/udbyttevurdering.
English: WITHDRAWAL PERIOD(S) Not applicable.
Danish: 10. TILBAGEHOLDELSESTID(ER) Ikke relevant.
English: Studies in dogs and cats show that anticholinergic premedication is compatible with sevoflurane anaesthesia in dogs and cats.
Danish: Undersøgelser i hunde og katte viser, at antikolinerg præmedicinering er forligelige med sevofluran anæstesi hos hunde og katte.
English: The necessity for and choice of premedication is left to the discretion of the veterinarian.
Danish: Behovet for og valget af præmedicin er overladt til dyrlægens skøn.
English: Facilities for artificial ventilation, oxygen enrichment and circulatory resuscitation should be immediately available.
Danish: Udstyr til kunstig ventilation, ilttilførsel og kredsløbsgenopretning bør være umiddelbart tilgængeligt.
English: Respiratory depression may lead to respiratory acidosis and respiratory arrest (at sevoflurane concentrations of 2.0 MAC and above) in spontaneously breathing dogs and cats.
Danish: Respirationsdpression kan føre til respiratorisk acidose og respirationsstop (ved sevoflurankoncentrationer på 2,0 MAC og derover) hos spontant respirerende hunde og katte.
English: • Care should be taken when dispensing SevoFlo, with immediate removal of any spillage.
Danish: • Der skal udvises forsigtighed ved påfyldning af SevoFlo, med umiddelbar fjernelse af spild.
English: Serum fluoride fell quickly after anaesthesia ended and had returned to baseline by 24 hours post-anaesthesia.
Danish: Serum fluorid faldt hurtigt efter afslutning af anæstesien og var tilbage på udgangspunktet 24 timer efter anæstesien.
English: Parent compound (the dominant fraction) is eliminated via the lungs.
Danish: Modersubstansen (den dominerende fraktion) elimineres via lungerne.
English: Since the reaction of carbon dioxide with absorbents is exothermic, this temperature increase will be determined by the quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anaesthetic circle system, metabolic status of the dog and ventilation.
Danish: Da reaktionen mellem kuldioxid og absorberende stoffer er eksotermisk, vil denne temperaturstigning være bestemt af den absorberede mængde CO2, hvilket igen vil afhænge af friskgas flow i anæstesi-cirkelsystemet, hundens metaboliske status og ventilation.
English: Preanaesthetic doses for premedicants may be lower than the label directions for their use as a single medication.
Danish: Præanæstetisk dosering af præmedicin kan være lavere end doseringsvejledningerne for anvendelse som eneste medicin.
English: In dogs with head injuries or other conditions placing them at risk from increased ICP, it is recommended that hypocapnia be induced by means of controlled hyperventilation as a means of preventing changes in ICP.
Danish: Hos hunde med kranietraumer eller andre tilstande, der bringer dem i risiko ved et forhøjet ICP, anbefales, at der for at forebygge ændringer i ICP etableres hypokapni ved hjælp af kontrolleret hyperventilation.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 100% sevoflurane
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 100% sevofluran
English: Sevoflurane administration is compatible with the intravenous barbiturates and propofol and in cats alfaxalone and ketamine.
Danish: Tilførsel af sevofluran er forligelig med intravenøse barbiturater og propofol, og hos katte med alfaxalon og ketamin.
English: In a laboratory study, the use of an acepromazine/oxymorphone/thiopental/sevoflurane anaesthetic regimen resulted in prolonged recoveries in all the dogs treated, compared to recoveries in dogs anaesthetised with sevoflurane alone.
Danish: I en laboratorieundersøgelse førte anvendelse af en anæstesiprocedure med acepromazin/oxymorphon/tiopental/sevofluran til forlænget opvågning hos alle de behandlede hunde sammenlignet med opvågningen hos hunde, der kun blev behandlet med sevofluran.
English: Sevoflurane may cause a small increase in intracranial pressure (ICP) under conditions of normocapnia in dogs.
Danish: Sevofluran kan forårsage en lille stigning i det intrakranielle tryk (ICP) under normokapniske omstændigheder hos hunde.
English: Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC. Sevoflurane causes systemic vasodilation and produces dosedependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Danish: Sevofluran har en varierende virkning på hjertefrekvensen, som har en tendens til at øge fra udgangspunktet ved lav MAC og gå ned ved øgende MAC. Sevofluran fremkalder systemisk vasodilatation og medfører dosisafhængige fald i det arterielle middelblodtryk, total perifer modstand, hjertets minutvolumen og muligvis i myokardiets kontraktionsstyrke og relakseringshastighed.
English: In common with all volatile agents, sevoflurane may cause hypotension in hypovolaemic animals such as those requiring surgery to repair traumatic injury, and lower doses should be administered in combination with appropriate analgesics.
Danish: Ligesom andre flygtige stoffer, kan sevofluran forårsage hypotension hos hypovolæmiske dyr, såsom dyr, der kræver operation for at udbedre traumatiske skader, og der skal gives lavere doser i kombination med passende analgetika.
English: SevoFlo is presented in a cardboard box containing a 250 ml polyethylene naphthalate (PEN) bottle with a Quik-Fil closure.
Danish: SevoFlo udleveres i papkarton indeholdende en 250 ml polyetylennafthalat (PEN)-flaske med QuikFil-låg.
English: In dogs exposed to 4% sevoflurane for 3 hours, mean peak maximum serum fluoride concentrations of 20.0 ± 4.8 µmol/l have been observed after 3 hours of anaesthesia.
Danish: Hos hunde, der har fået 4% sevofluran i 3 timer, er der observeret middel maksimalkoncentrationer af serum fluorid på 20,0 ± 4,8 µmol/l efter 3 timers anæstesi.
English: Once formed, HFIP is rapidly conjugated with glucuronic acid and eliminated as a urinary metabolite.
Danish: Så snart det er dannet, konjugeres HFIP hurtigt med glukoronsyre og elimineres som metabolit i urinen.
English: Arterial blood pressure should be monitored at frequent intervals during sevoflurane anaesthesia.
Danish: Det arterielle blodtryk bør kontrolleres med hyppige intervaller under sevofluran anæstesi.
English: In dogs concentrations of sevoflurane below 2.0 MAC result in a small net increase in total liver blood flow.
Danish: Sevoflurankoncentrationer under 2,0 MAC resulterer i en lille netto forøgelse af den totale levergennemblødning hos hunde.
English: The use of sevoflurane with nondepolarising muscle relaxants has not been evaluated in dogs.
Danish: Brugen af sevofluran sammen med non-depolariserende muskelrelaksantia er ikke belyst hos hunde.
English: In order to minimise this reaction in rebreathing anaesthetic circuits, SevoFlo should not be passed through soda lime or barium hydroxide that has been allowed to dry out.
Danish: For at reducere denne reaktion i anæstesisystemer med genånding, bør SevoFlo ikke passere gennem natronkalk eller bariumhydroxid, som har fået lov til at tørre ud.
English: If eye exposure occurs, the eye should be flushed with plenty of water for 15 minutes.
Danish: I tilfælde af kontakt med øjnene skal øjnene skylles med rigeligt vand i 15 minutter.
English: • Avoid using masking procedures for prolonged induction and maintenance of general anaesthesia.
Danish: • Undgå at anvende maskeprocedurer til langvarig induktion og vedligeholdelse af generel anæstesi
English: Do not use in animals with a known or suspected genetic susceptibility to malignant hyperthermia.
Danish: Bør ikke anvendes til dyr med kendt eller mistænkt genetisk tilbøjelighed til malign hypertermi.
English: • Halogenated anaesthetic agents may induce liver damage.
Danish: • Halogenerede anæstesimidler kan medføre leverskade.
English: In cats sevoflurane has been shown to exert some neuromuscular blocking effect, but this is only apparent at high doses.
Danish: Hos katte er det vist, at sevofluran udøver nogen neuromuskulær blokade, men dette ses kun ved høje doser.
English: Sevoflurane has a depressive effect on respiration characterised by a fall in ventilation frequency.
Danish: Sevofluran har en respirationsdeprimerende virkning, karakteriseret ved et fald i respirationsfrekvensen.
English: Limited data are available on the effects of the highly potent alpha-2agonists (medetomidine, romifidine and dexmedetomidine) as premedication.
Danish: Der findes begrænsede data angående virkningerne af de højpotente alfa-2-agonister (medetomidin, romifidin og dexmedetomidin) som præmedicin.
English: Clinical data for the cat indicate rapid onset of, and recovery from, sevoflurane anaesthesia.
Danish: Kliniske data hos katten indikerer hurtig indtræden af, og restitution efter, sevofluran anæstesi.
English: Sevoflurane produces only modest increases in cerebral blood flow and metabolic rate, and has little or no ability to potentiate seizures.
Danish: Sevofluran giver kun beskeden stigning i den cerebrale gennemblødning og metabolisme og har ingen eller kun ringe evne til at udløse kramper.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE
English: In the dog sevoflurane may increase intracranial pressure at concentrations of 2.0 MAC and above under normal partial pressures of carbon dioxide (normocapnia), but intracranial pressure has been shown to remain within normal range at sevoflurane concentrations of up to 1.5 MAC if hypocapnia is induced by hyperventilation.
Danish: Hos hunde kan sevofluran ved normalt partialtryk af kuldioksid (normokapni), øge det intrakranielle tryk ved koncentrationer på 2,0 MAC og derover, men det er vist, at det intrakranielle tryk forbliver indenfor normalområdet ved sevoflurankoncentrationer på op til 1,5 MAC, hvis der etableres hypokapni ved hjælp af hyperventilation.
English: Αlpha-2-agonists have an anaesthetic sparing effect and therefore the dose of sevoflurane should be reduced accordingly.
Danish: Alfa-2-agonister har en anæstesibesparende virkning og dosis af sevofluran skal reduceres i overensstemmelse hermed.
English: Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other appropriate techniques.
Danish: Kardiovaskulær depression skal behandles med plasmaekspandere, pressorstoffer, antiarytmika eller andre hensigtsmæssige teknikker.
English: SevoFlo contains no stabiliser and does not affect the calibration or operation of these vaporisers.
Danish: SevoFlo indeholder ingen stabilisator og påvirker ikke kalibreringen eller funktionen af disse fordampere.