FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, SevoFlo has been commonly used off-label (use that is not officially authorised) as an anaesthetic for cats for more than 10 years and therefore its use in cats is considered to be ‘well-established'.
Danish: SevoFlo har desuden har været almindeligt anvendt "off-label" (anvendelse, som ikke er officielt godkendt) til bedøvelse af katte i over ti år, og anvendelsen heraf hos katte er derfor "almindeligt anerkendt".
English: The European Medicine's Agency decided that SevoFlo's benefits are greater that its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved SevoFlo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about SevoFlo
Danish: Andre oplysninger om SevoFlo
English: SevoFlo received a marketing authorisation valid throughout the EU for SevoFlo on 11 December
Danish: SevoFlo modtog en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 11. december 2002.
English: When a dog or cat is given a mixture of oxygen and sevoflurane to breathe, the sevoflurane is inhaled into its lungs and is carried by the blood into the brain.
Danish: Når en hund eller kat gives en blanding af ilt og sevofluran til at indånde, inhaleres sevofluranen ned i lungerne og transporteres via blodet til hjernen.
English: Sevoflurane mimics the action of GABA, a substance that naturally reduces brain activity, and blocks the action of glutamate, which stimulates the activity of the brain.
Danish: Sevofluran efterligner virkningen af GABA, som er et stof, der naturligt nedsætter hjerneaktiviteten, og som blokerer virkningen af glutamat, der stimulerer hjerneaktiviteten.
English: The effectiveness of SevoFlo was comparable to isoflurane.
Danish: Virkningen af SevoFlo var sammenlignelig med virkningen af isofluran.
English: SevoFlo must not be given to animals with a genetic susceptibility to malignant hyperthermia.
Danish: SevoFlo må ikke gives til dyr, som er genetisk disponeret for malign hypertermi.
English: The dog or cat breathes in the gas mixture, which causes it to become unconscious.
Danish: Hunden eller katten indånder gasblandingen og bliver derved bevidstløs.
English: Pregnant and breast-feeding women must not come into contact with the product and they should also avoid operating rooms and animal recovery areas where the product is being used or has recently been used.
Danish: Gravide og ammende kvinder må ikke komme i kontakt med lægemidlet og bør heller ikke opholde sig i operationsrum og opvågningsområder, hvor det anvendes eller for nylig har været anvendt.
English: Studies in dogs found that SevoFlo was as effective at starting and maintaining anaesthesia as other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam.
Danish: Studier hos hunde viste, at SevoFlo var lige så effektivt til at fremkalde og vedligeholde bedøvelse som andre bedøvelsesmidler, såsom isofluran (en anden bedøvelsesgas), thiopental, propofol, og ketamin plus diazepam.
English: Studies showed that sevoflurane could be used safely with several other medicines commonly used in dogs before or during operations, for maintenance of anaesthesia.
Danish: Studierne viste, at sevofluran kunne anvendes sikkert sammen med flere andre lægemidler, som almindeligvis anvendes hos hunde før eller under operationer, til vedligeholdelse af bedøvelse.
English: SevoFlo is given using specialised anaesthetic equipment, usually in a carefully controlled gas mixture including oxygen.
Danish: SevoFlo gives ved hjælp af specielt bedøvelsesudstyr, normalt i en nøje kontrolleret gasblanding med ilt.
English: For the full list of side effects of SevoFlo, and for the full list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved SevoFlo og den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: An overview of SevoFlo and why it is authorised in the EU
Danish: Oversigt over SevoFlo, og hvorfor det er godkendt i EU
English: What is SevoFlo and what is it used for?
Danish: Hvad er SevoFlo, og hvad anvendes det til?
English: For cats, a review of published scientific literature showed that SevoFlo is effective for anaesthesia and that it is compatible with a range of sedative and pain-relieving medicines used in anaesthesia.
Danish: For katte viste en gennemgang af den videnskabelige litteratur, at SevoFlo var effektivt til bedøvelse og var kompatibelt med en række beroligende og smertestillende lægemidler, som anvendes i forbindelse med bedøvelse.
English: Why is SevoFlo authorised in the EU?
Danish: Hvorfor blev SevoFlo godkendt i EU?
English: For more information about using SevoFlo, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af SevoFlo, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Safety information has been included in the summary of product characteristics and the package leaflet for SevoFlo, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for SevoFlo, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: What are the risks associated with SevoFlo?
Danish: Hvilke risici er der forbundet med SevoFlo?
English: The most common side effects with SevoFlo, which may affect more than 1 in 10 animals, are low blood pressure, rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches and vomiting.
Danish: De hyppigste bivirkninger ved SevoFlo (som kan optræde hos mere end 1 ud af 10 dyr) er lavt blodtryk, hurtig vejrtrækning, muskelspændinger, irritation, midlertidigt vejrtrækningsstop, sitren og opkastning.
English: It contains the active substance sevoflurane, a chemical which is a liquid at room temperature, but when heated becomes a gas (vaporises).
Danish: Det er et kemisk stof, der ved rumtemperatur er en væske, men som bliver til en gas (fordamper), når det opvarmes.
English: If a person accidentally inhales sevoflurane vapour, this may cause symptoms such as shivering, nausea, headache, low blood pressure, decreased heart rate and even reduced breathing.
Danish: Hvis en person ved et uheld indånder sevoflurandampe, kan der forekomme symptomer som kulderystelser, kvalme, hovedpine, lavt blodtryk, langsom hjerterytme og endda langsom vejrtrækning.
English: SevoFlo is a general anaesthetic for dogs and cats.
Danish: SevoFlo anvendes til fuld bedøvelse af hunde og katte.
English: SevoFlo is used to bring about and maintain general anaesthesia (loss of consciousness).
Danish: SevoFlo anvendes til at fremkalde og opretholde fuld bedøvelse (bevidstløshed).
English: Care must therefore be taken when handling SevoFlo: any spillage must be removed immediately, the vapour must not be inhaled, and any contact with the product by mouth must be avoided.
Danish: Eventuelt spild skal straks fjernes, dampene må ikke indåndes, og lægemidlet må ikke komme i kontakt med munden.
English: This is a rare life-threatening condition usually triggered by exposure to certain general anaesthetics that is associated with muscle spasm and very high body temperatures.
Danish: Dette er en sjælden, livstruende tilstand, der er forbundet med muskelspasmer og en meget høj kropstemperatur, der normalt udløses af eksponering for visse midler til fuld bedøvelse.
English: In case of accidental contact with the skin or eyes, or for more information, the package leaflet should be consulted.
Danish: I tilfælde af utilsigtet hud- eller øjenkontakt skal man følge anvisningerne i indlægssedlen.
English: How is SevoFlo used?
Danish: Hvordan anvendes SevoFlo?
English: How does SevoFlo work?
Danish: Hvordan virker SevoFlo?
English: What benefits of SevoFlo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved SevoFlo?
English: SevoFlo produced a relatively rapid and smooth start of anaesthesia in dogs, followed by a good recovery.
Danish: Den bedøvende virkning af SevoFlo hos hunde indtrådte forholdsvis hurtigt og uden problemer, og opvågnen efter bedøvelsen forløb fint.
English: It has no agonist activity.
Danish: Det har ingen agonist-aktivitet.
English: Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, Hungary, Iceland, Ireland, Luxembourg, The Netherlands, Norway, Slovakia, Slovenia, Spain, Sweden
Danish: Belgien, Cypern, Estland, Finland, Grækenland, Holland, Irland, Island, Luxembourg, Norge, Slovakiet, Slovenien, Spanien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig
English: Try to take the tablet at the same time each day.
Danish: Forsøg at tage tabletten på samme tid hver dag.
English: France, Portugal
Danish: Frankrig, Portugal
English: Animal studies are insufficient.
Danish: Data fra dyreforsøg er utilstrækkelige.
English: The following measures are, however, suggested in case of overdose.
Danish: Imidlertid foreslås følgende forholdsregler i tilfælde af overdosering:
English: Concomitant intake of food increases the absorption by approximately 15%.
Danish: Samtidig fødeindtagelse øger absorptionen med ca. 15 %.
English: Atacand Plus is indicated for the:
Danish: Atacand Plus er indiceret til:
English: Sugar in your urine.
Danish: • Sukker i urinen.
English: A similar effect has also been reported with AIIRAs.
Danish: En tilsvarende virkning er indberettet for AIIRA'er.
English: It is important to keep taking Atacand Plus every day.
Danish: Det er vigtigt at fortsætte med at tage Atacand Plus hver dag.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslandene under følgende navne: Navn
English: Approximately 70% of an oral dose is eliminated in the urine within 48 hours.
Danish: Ca. 70 % af en oral dosis elimineres i urinen inden for 48 timer.
English: Taking Atacand Plus with food and drink (in particular alcohol)
Danish: Brug af Atacand Plus sammen med mad og drikke (især alkohol)
English: you have ever had allergy or asthma.
Danish: - hvis du har/har haft allergi eller astma.
English: It is used for treating high blood pressure (hypertension) in adult patients.
Danish: Det bruges til at behandle forhøjet blodtryk (hypertension) hos voksne patienter.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Danish: Der er begrænset erfaring med hydrochlorthiazid under graviditet, især i første trimester.
English: There was no evidence that either compound is carcinogenic.
Danish: Der var intet tegn på, at nogen af komponenterne var karcinogene.
English: Sympathomimetic medicinal products may be administered if the above-mentioned measures are not sufficient.
Danish: Sympatomimetiske lægemidler kan gives, hvis de ovennævnte tiltag ikke slår til.
English: It makes your blood vessels relax and widen.
Danish: Det får dine blodårer til at slappe af og udvide sig.
English: It helps your body to get rid of water and salts like sodium in your urine.
Danish: Det hjælper din krop med at udskille vand og salte som f.eks. natrium i urinen.
English: Steroids such as prednisolone.
Danish: • Steroider såsom prednisolon.
English: If you are using certain medicines, your doctor may need to do blood tests from time to time.
Danish: Hvis du tager visse typer medicin, vil din læge eventuelt tage blodprøver indimellem.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Non-Perforated calendar foil (7, 14, 28, 56 and 98 tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT Ikke-perforerede kalender-blisterkort (7, 14, 28, 56 og 98 tabletter)
English: Candesartan is highly bound to plasma protein (more than 99%).
Danish: Candesartan er stærkt bundet til plasmaproteiner (mere end 99 %).
English: There is no experience with the use of Atacand Plus in children (below the age of 18 years).
Danish: Der er ingen erfaring med brugen af Atacand Plus hos børn (under 18 år).
English: The bioavailability of candesartan is not affected by food.
Danish: Biotilgængeligheden af candesartan påvirkes ikke af mad.
English: Your doctor may occasionally do blood tests to check whether Atacand Plus has had any effect on your blood (agranulocytosis).
Danish: Din læge vil eventuelt tage nogle blodprøver indimellem for at undersøge, om Atacand Plus har påvirket dit blod (agranulocytose).
English: Available interaction studies indicate no effect on CYP2C9 and CYP3A4.
Danish: De tilgængelige interaktionsundersøgelser indikerer ingen effekt på CYP2C9 og CYP3A4.
English: Dose adjustment of antidiabetic medicinal products, including insulin, may be required.
Danish: Dosisjustering af antidiabetika, herunder insulin, kan være nødvendig.
English: Penicillin (an antibiotic).
Danish: • Penicillin (antibiotika).
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Danish: Hydrochlorthiazid bør ikke anvendes til essentiel hypertension hos gravide kvinder undtagen i sjældne situationer, hvor anden behandling ikke har kunnet anvendes.
English: Therefore do not stop taking Atacand Plus without first talking to your doctor.
Danish: Derfor må du ikke holde op med at tage Atacand Plus uden først at have talt med din læge.
English: Elderly population No dose adjustment is necessary in elderly patients.
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter.
English: Important information about some of the ingredients of Atacand Plus Atacand Plus contains lactose which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Atacand Plus Atacand Plus indeholder lactose, som er en form for sukker.
English: It also has a role in the pathogenesis of organ hypertrophy and end organ damage.
Danish: Det har også en rolle i patogenesen for organhypertrofi og målorganets beskadigelse.
English: Loop diuretics are preferred to thiazides in this population.
Danish: Loop-diuretika bør foretrækkes frem for thiazider til denne population.
English: Some people may feel tired or dizzy when taking Atacand Plus.
Danish: Nogle personer kan føle træthed eller svimmelhed, når de tager Atacand Plus.
English: Therefore, the use of Atacand Plus is not recommended until this condition has been corrected.
Danish: Atacand Plus bør derfor ikke bruges, før denne tilstand er blevet korrigeret.
English: Angiotensin II Receptor Antagonists (AIIRAs):
Danish: Angiotensin II-receptor-antagonister (AIIRA'er):
English: Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.
Danish: Størstedelen af den antihypertensive effekt opnås almindeligvis inden for 4 uger efter påbegyndt behandling.
English: Pituitary hormone (ACTH).
Danish: • Hypofysehormon (ACTH).
English: Medicines for diabetes (tablets or insulin).
Danish: • Medicin mod diabetes (tabletter eller insulin).
English: Your doctor will normally advise you to stop taking Atacand Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Atacand Plus.
Danish: Din læge vil almindeligvis råde dig til at holde op med at tage Atacand Plus, før du bliver gravid, eller så snart som du bliver opmærksom på, at du er gravid, og vil råde dig til at tage anden medicin i stedet for Atacand Plus.
English: The frequencies used in the tables throughout section 4.8 are: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Danish: 4.8, er: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Atacand Plus can be taken with or without food.
Danish: Atacand Plus kan tages med eller uden mad.
English: Therefore Atacand Plus should not be given to children.
Danish: Atacand Plus må derfor ikke gives til børn.
English: The blood pressure was reduced from 166/90 to 145/80 mmHg in the candesartan group, and from 167/90 to 149/82 mmHg in the control group.
Danish: Blodtrykket blev reduceret fra 166/90 til 145/80 mmHg i candesartangruppen og fra 167/90 til 149/82 mmHg i kontrolgruppen.
English: Just take the next dose as normal.
Danish: Fortsæt blot med den sædvanlige dosis.
English: If re-administration of treatment is essential, it is recommended to protect areas exposed to the sun or to artificial UVA radiation.
Danish: Hvis det er vigtigt at genoptage behandlingen, anbefales det, at de områder, der udsættes for sollys eller kunstig UVA-stråling, beskyttes.
English: If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs monitored.
Danish: I tilfælde af symptomatisk hypotension skal der iværksættes symptomatisk behandling, og de vitale funktioner skal monitoreres.
English: Atacand Plus may cause a reduction in number of white blood cells.
Danish: Atacand Plus kan medføre nedsættelse af antallet af hvide blodlegemer.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Danish: Så længe der ikke foreligger kontrollerede, epidemiologiske data om risikoen med AIIRA'er, kan der være lignende risici ved denne gruppe lægemidler.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ}.
English: Periodic monitoring of serum potassium is recommended when Atacand Plus is administered with such medicinal products, and with the following medicinal products that could induce torsades de pointes:
Danish: Periodisk monitorering af serumkalium anbefales, når Atacand Plus administreres sammen med sådanne lægemidler og med følgende lægemidler, der kan inducere torsades de pointes:
English: Since there is no effect on the degradation of kinins, or on the metabolism of other substances, such as substance P, AIIRAs are unlikely to be associated with cough.
Danish: Eftersom der ikke er nogen virkning på nedbrydningen af kininer eller på metabolismen af andre substanser, som f.eks. substans P, er det ikke sandsynligt, at AIIRAbehandling er forbundet med hoste.
English: you have a disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism).
Danish: - hvis du har en sygdom i binyrerne, som kaldes Conns syndrom (kaldes også primær hyperaldosteronisme).
English: These changes were considered to be caused by the pharmacological action of candesartan and to be of little clinical relevance.
Danish: Disse ændringer blev vurderet som værende fremkaldt af candesartans farmakologiske virkning og til at have ringe klinisk relevans.
English: Do not use Atacand Plus after the expiry date which is stated on the carton, blister pack or bottle.
Danish: • Brug ikke Atacand Plus efter den udløbsdato, der står på pakningen, blisterkortet eller medicinglasset.
English: There is no clinically significant interaction between hydrochlorothiazide and food.
Danish: Der er ingen klinisk signifikant interaktion mellem hydrochlorthiazid og mad.
English: Atacand Plus once daily provides effective and smooth blood pressure reduction over 24 hours, with little difference between maximum and trough effects during the dosing interval.
Danish: Atacand Plus en gang dagligt giver effektiv og jævn blodtryksreduktion over 24 timer med ringe forskel mellem maksimum- og minimumvirkningen i løbet af doseringsintervallet.
English: A reduction in your red or white blood cells or platelets.
Danish: • Et fald i de røde eller hvide blodlegemer eller blodpladerne.
English: Labelling
Danish: ETIKETTERING
English: Very rarely, hypotension may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.
Danish: Meget sjældent kan hypotensionen være så alvorlig, at det kræver anvendelse af intravenøs væske og/eller vasopressorbehandling.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis kombinationen er nødvendig, anbefales tæt monitorering af serum-lithium.
English: However, the blood pressure response and the incidence of adverse events are similar after a given dose of Atacand Plus in young and elderly patients (see section 4.2).
Danish: Blodtryksreduktion og bivirkningsfrekvens er dog ens efter en given dosis af Atacand Plus hos yngre og ældre patienter (se punkt 4.2).
English: If this is not sufficient, plasma volume should be increased by infusion of isotonic saline solution.
Danish: Hvis dette ikke er tilstrækkeligt, bør plasmavolumen øges ved infusion af isotonisk natriumchloridopløsning.
English: If a photosensitivity reaction occurs, it is recommended to stop treatment.
Danish: Hvis en lysfølsomhedsreaktion forekommer, anbefales det, at behandlingen seponeres.
English: Based on in vitro data, no interaction would be expected to occur in vivo with medicinal products whose metabolism is dependent upon cytochrome P450 isoenzymes CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4.
Danish: Baseret på in vitro data forventes der ingen interaktion in vivo med lægemidler, hvis metabolisme er afhængig af cytokrom P450-isoenzymerne CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4.
English: At the doses contained in Atacand Plus, only minimal effects were observed.
Danish: Ved de doser, som Atacand Plus indeholder, er kun observeret minimal effekt.
English: Following an oral dose of 14C-labelled candesartan cilexetil, approximately 26% of the dose is excreted in the urine as candesartan and 7% as an inactive metabolite while approximately 56% of the dose is recovered in the faeces as candesartan and 10% as the inactive metabolite.
Danish: Efter en oral dosis af 14C mærket candesartancilexetil udskilles ca. 26 % af dosis i urinen som candesartan og 7 % som en inaktiv metabolit, mens ca. 56 % af dosis genfindes i fæces som candesartan og 10 % som den inaktive metabolit.
English: High temperature (fever).
Danish: • Forhøjet temperatur (feber).
English: When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment with Atacand Plus.
Danish: Når der føres motorkøretøj eller betjenes maskiner, skal der tages højde for, at der lejlighedsvist kan optræde svimmelhed og træthed under behandling med Atacand Plus.
English: With continuous treatment, most of the reduction in blood pressure is attained within four weeks and is sustained during long-term treatment.
Danish: Ved fortsat behandling opnås størstedelen af blodtryksreduktionen i løbet af 4 uger, og den opretholdes under langtidsbehandling.
English: After administration of a single dose of Atacand Plus, onset of the antihypertensive effect generally occurs within 2 hours.
Danish: Efter indgift af en enkelt dosis Atacand Plus indtræder den antihypertensive virkning sædvanligvis inden for 2 timer.
English: You can take Atacand Plus with or without food.
Danish: • Du kan tage Atacand Plus med eller uden mad.
English: Withdrawals from treatment due to adverse events were similar with candesartan cilexetil/hydrochlorothiazide (2.3-3.3%) and placebo (2.7-4.3%).
Danish: Afbrydelse af behandlingen på grund af bivirkninger var ens for candesartancilexetil/hydrochlorthiazid (2,3-3,3 %) og placebo (2,7-4,3 %).
English: Patients received candesartan or placebo with other antihypertensive treatment added as needed.
Danish: Patienterne fik candesartan eller placebo sammen med anden antihypertensiv behandling, som blev tillagt efter behov.
English: There was no statistically significant difference in the primary endpoint, major cardiovascular events (cardiovascular mortality, non-fatal stroke and non-fatal myocardial infarction).
Danish: Der var ingen statistisk signifikant forskel for det primære endepunkt, større kardiovaskulære hændelser (kardiovaskulær mortalitet, ikke-letal apopleksi og ikke-letal myokardieinfarkt).