FrancophonIA/ELRC3.0 huggingface dataset:
English: When adding Byetta to a sulphonylurea or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels).
Danish: Når Byetta føjes til et sulfonylurinstof eller basal insulin, kan det være nødvendigt for lægen at nedsætte dosis af sulfonylurinstoffet eller den basale insulin, fordi der er risiko for hypoglycæmi (lavt blodsukkerindhold).
English: What is the risk associated with Byetta?
Danish: Hvilken risiko er der forbundet med Byetta?
English: It can be used with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, or metformin and a thiazolidinedione.
Danish: Det kan anvendes sammen med metformin, sulfonylurinstoffer, thiazolidindioner, metformin og et sulfonylurinstof eller metformin og et thiazolidindion.
English: Why has Byetta been approved?
Danish: Hvorfor blev Byetta godkendt?
English: Two further studies compared adding Byetta or an insulin to metformin and sulphonylureas.
Danish: I to andre undersøgelser sammenlignede man tilføjelse af Byetta eller et insulin til metformin og sulfonylurinstoffer.
English: Byetta can also be given to patients taking basal insulin (long-acting insulin such as insulin glargine) with or without metformin and/or pioglitazone (a thiazolidinedione) and whose blood glucose levels are not adequately controlled with these medicines.
Danish: Byetta kan også gives til patienter, som tager basal insulin (langtidsvirkende insulin såsom insulin glargin) med eller uden metformin og/eller pioglitazon (et thiazolidinedion), og hvis blodglukosemængder ikke er tilfredsstillende reguleret med disse lægemidler.
English: For the full list of all side effects reported with Byetta, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Byetta fremgår af indlægssedlen.
English: This helps with the control of blood glucose levels.
Danish: På denne måde er lægemidlet med til at regulere glukoseniveauet.
English: In another study involving 259 patients, Byetta was compared with placebo, as an add-on to insulin glargine.
Danish: I en anden undersøgelse, som omfattede 259 patienter, blev Byetta sammenlignet med placebo som tillægsbehandling til insulin glargin.
English: Byetta was more effective than placebo when it was given as add-on to insulin glargine (with or without other antidiabetes medications), as Byetta decreased HbA1c by an average of 1.7% compared with an average of 1.0% in patients taking placebo.
Danish: Byetta var mere effektivt end placebo, når det blev givet som tillægsbehandling til insulin glargin (med eller uden andre lægemidler mod diabetes), da Byetta fik HbA1c til at falde med gennemsnitlig 1,7 % sammenlignet med gennemsnitlig 1,0 % hos patienter, som fik placebo.
English: In five of the studies, Byetta was compared with placebo (a dummy treatment), as an add-on to metformin (336 patients), sulphonylureas with or without metformin (1,110 patients) or thiazolidinediones with or without metformin (398 patients).
Danish: I fem af undersøgelserne blev Byetta sammenlignet med placebo (en virkningsløs behandling) som tillægsbehandling til metformin (336 patienter), sulfonylurinstoffer med eller uden metformin (1 110 patienter) eller thiazolidindioner med eller uden metformin (398 patienter).
English: In studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were hypoglycaemia (when Byetta was used with sulphonylurea with or without metformin), nausea (feeling sick), vomiting and diarrhoea.
Danish: I undersøgelserne var de hyppigste bivirkninger ved Byetta (som optrådte hos flere end 1 ud af 10 patienter) hypoglycæmi (når Byetta blev anvendt sammen med et sulfonylurinstof med eller uden metformin), kvalme, opkastning og diarré.
English: Byetta is given by injection under the skin of the thigh, the abdomen (tummy) or the upper arm, using the injection pen.
Danish: Byetta gives som en injektion under huden i låret, maven eller overarmen ved hjælp af injektionspennen.
English: A dose higher than 10 micrograms twice a day is not recommended.
Danish: Det anbefales ikke at bruge en højere dosis end 10 mikrogram to gange dagligt.
English: What is Byetta?
Danish: Hvad er Byetta?
English: In one study, Byetta was compared with insulin glargine in 456 patients and in the other study it was compared with biphasic insulin in 483 patients.
Danish: I den ene undersøgelse, der omfattede 456 patienter, blev Byetta sammenlignet med insulin glargin, og i den anden, der omfattede 483 patienter, blev Byetta sammenlignet med bifasisk insulin.
English: When it was added to metformin and/or sulphonylureas, the 5-microgram dose of Byetta decreased HbA1c levels by an average of 0.59% after 30 weeks, and the 10-microgram dose decreased them by an average of 0.89%.
Danish: Når det blev føjet til metformin og/eller sulfonylurinstoffer, nedsatte en 5 mikrogramsdosis af Byetta HbA1c-niveauerne med gennemsnitlig 0,59 % efter 30 uger, og en 10 mikrogramsdosis nedsatte dem med gennemsnitlig 0,89 %.
English: When added to thiazolidinediones with or without metformin, the 10-microgram dose of Byetta reduced HbA1c levels by an average of 0.74% after 16 weeks and 0.84% after 26 weeks.
Danish: Når det blev føjet til thiazolidindioner med eller uden metformin, reducerede en 10 mikrogramsdosis af Byetta HbA1c-niveauerne med gennemsnitlig 0,74 % efter 16 uger og 0,84 % efter 26 uger.
English: The 10-microgram dose of Byetta decreased HbA1c by an average of 1.13% after 26 weeks, compared with an average of 1.10% with insulin glargine.
Danish: En 10 mikrogramsdosis af Byetta reducerede HbA1c med gennemsnitlig 1,13 % efter 26 uger sammenlignet med et gennemsnit på 1,10 % med insulin glargin.
English: In the final study, the 10-microgram dose of Byetta decreased HbA1c by an average of 1.01% after 52 weeks, compared with an average of 0.86% with biphasic insulin.
Danish: I den endelige undersøgelse reducerede en 10 mikrogramsdosis af Byetta HbA1c med gennemsnitlig 1,01 % efter 52 uger sammenlignet med et gennemsnit på 0,86 % med bifasisk insulin.
English: What is Byetta used for?
Danish: Hvad anvendes Byetta til?
English: How has Byetta been studied?
Danish: Hvordan blev Byetta undersøgt?
English: What benefit has Byetta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Byetta?
English: How is Byetta used?
Danish: Hvordan anvendes Byetta?
English: How does Byetta work?
Danish: Hvordan virker Byetta?
English: Adding Byetta to metformin or pioglitazone is not associated with this risk.
Danish: Denne risiko opstår ikke, når Byetta anvendes sammen med metformin eller et thiazolidindion.
English: In addition, aggressive behaviour was observed.
Danish: Desuden blev aggressiv adfærd observeret.
English: Number of tablets per day
Danish: Antal tabletter pr. dag
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på flasken.
English: One bottle per carton.
Danish: Én flaske pr. æske.
English: Fluoxetine is well absorbed after oral administration (approximately72%) and the absorption is not affected by feeding.
Danish: Fluoxetin absorberes godt efter oral administration (cirka 72 %), og absorptionen påvirkes ikke af fodring.
English: Therefore, fluoxetine should be used with caution with other veterinary medicinal products.
Danish: Derfor bør fluoxetin anvendes med forsigtighed sammen med andre veterinærlægemidler.
English: At the end of treatment it is not necessary to taper or reduce doses because of the long half-life of this veterinary medicinal product.
Danish: Ved afslutningen af behandlingen er det ikke nødvendigt at gradvist nedsætte eller reducere doseringer, grundet dette veterinærlægemiddels lange halveringstid.
English: If no improvement is noted within 4 weeks, case management should be re-evaluated.
Danish: Hvis der ikke ses forbedring inden for 4 uger, bør behandlingen af tilfældet re-evalueres.
English: This product should only be used in conjunction with a behaviour modification programme recommended by your veterinary surgeon.
Danish: Dette produkt bør kun anvendes i forbindelse med et modifikationsprogram for adfærd anbefalet af Deres dyrlæge.
English: Please inform your veterinary surgeon if your dog is receiving, or has had, any other medicines, even those not prescribed, as the product should not be given at the same time as many other medicines.
Danish: Underret Deres dyrlæge, hvis Deres hund får eller har fået nogen anden medicin, også uden recept, da produktet ikke bør gives på samme tid som mange andre lægemidler.
English: Clinical improvement with the product is expected within 1 or 2 weeks.
Danish: Klinisk forbedring med produktet forventes inden for 1 eller 2 uger.
English: Reconcile tablets may be given with or without food.
Danish: Reconciletabletter kan gives med eller uden foder.
English: Fluoxetine does not act as a sedative.
Danish: Fluoxetin virker ikke som et sedativ.
English: Elimination studies in dogs have shown that 29.8% and 44% of the dose were excreted in urine and faeces, respectively by 14 days following dosing.
Danish: Eliminationsundersøgelser hos hunde har vist, at henholdsvis 29,8 % og 44 % af dosis blev udskilt i hhv. urin og fæces 14 dage efter dosering.
English: Clinical studies have shown that a beneficial response has been demonstrated for up to 8 weeks treatment with fluoxetine.
Danish: Kliniske studier har vist, at et gavnligt respons er blevet påvist ved op til 8 ugers behandling med fluoxetin.
English: Pack size of one bottle.
Danish: Pakningsstørrelse med én flaske.
English: Though rare, seizures may occur in dogs treated with the product.
Danish: Omend sjældne kan krampeanfald forekomme hos hunde, der behandles med produktet.
English: Fluoxetine is largely metabolised by the P-450 enzyme system, although the precise isoform in dogs is unknown.
Danish: Fluoxetin metaboliseres hovedsageligt af P-450 enzymsystemet, selvom den nøjagtige isoform hos hunde er ukendt.
English: Clinical improvement with the product is expected within 1 to 2 weeks.
Danish: Der forventes klinisk forbedring med produktet inden for 1 til 2 uger.
English: In clinical studies these side effects were stopped immediately upon intravenous administration of a standard dose of diazepam.
Danish: I kliniske undersøgelser ophørte disse bivirkninger med det samme ved intravenøs administration af en standarddosis diazepam.
English: Accumulation of fluoxetine and norfluoxetine occurred following multiple doses until reaching a steady-state within approximately 10 days.
Danish: Akkumulering af fluoxetin og norfluoxetin forekom efter multiple doser, indtil der opnåedes et steadystate inden for cirka 10 dage.
English: If a dose is missed, the next scheduled dose should be administered as prescribed.
Danish: Hvis en dosis springes over, bør den næste planlagte dosis gives som ordineret.
English: To minimize the risk of adverse reactions, the recommended dose should not be exceeded.
Danish: For at minimere risikoen for bivirkninger, bør den anbefalede dosis ikke overskrides.
English: Tablet strength (mg)
Danish: Tabletstyrke (mg)
English: EXP {month/year} Once opened, use by….
Danish: {måned/år} Efter åbning: anvendes inden…
English: Treatment should be stopped if seizures occur.
Danish: Behandlingen bør stoppes i tilfælde af anfald.
English: Norfluoxetine Cmax and AUC were generally dose proportional but these values were 3 to 4 fold higher on day 21 than on day 1.
Danish: Norfluoxetin Cmax og AUC var generelt dosisproportionale, men disse værdier var 3 til 4 gange højere på dag 21 end på dag 1.
English: Discard any tablets remaining 30 days after opening.
Danish: Kassér alle tabletter, som er tilovers 30 dage efter åbning.
English: Artificial beef flavour Silica, colloidal anhydrous Calcium hydrogen phosphate dihydrate Magnesium stearate
Danish: Kunstigt oksekødssmagsstof Silica, kolloidt vandfrit Calciumhydrogenfosfatdihydrat Magnesiumstearat
English: Reconcile should not be given concomitantly with veterinary medicinal products that lower the seizure threshold (e.g. phenothiazines such as acepromazine or chlorpromazine).
Danish: Reconcile bør ikke gives samtidig med veterinærlægemidler, der sænker tærsklen for krampeanfald (f.eks. fenotiaziner såsom acepromazin eller klorpromazin).
English: Adverse reactions as described above, including seizures, are more common after overdose.
Danish: Bivirkninger som beskrevet ovenfor, inklusive krampeanfald, er mere almindelige efter overdosis.
English: If no improvement is noted within 4 weeks, consult your veterinary surgeon who will need to re-evaluate the dog's treatment.
Danish: Hvis der ikke ses forbedring inden for 4 uger rådspørges dyrlægen, som så skal re-evaluere hundens behandling.
English: The tablets are flavoured and most dogs will consume the tablet when offered by the owner.
Danish: Tabletterne er tilsat smagsstof, og de fleste hunde vil indtage tabletten, når den tilbydes af ejeren.
English: Fluoxetine lacks any significant affinity for neurotransmitter receptors, including the muscarinic cholinergic receptor, adrenergic receptors, or histaminergic H1 receptors, and does not have direct effects on the heart.
Danish: Fluoxetin mangler enhver signifikant affinitet for neurotransmitterreceptorer, inklusive den muskarine kolinerge receptor, adrenerge receptorer, eller histaminerge H1-receptorer og har ikke nogen direkte virkning på hjertet.
English: Reconcile should be administered orally at a once daily dose of 1 to 2 mg/kg bodyweight according to the dosage table below:
Danish: Reconcile bør gives peroralt med en én gang daglig dosis på 1 til 2 mg/kg legemsvægt i henhold til doseringsskemaet nedenfor:
English: The tablets are packaged in HDPE bottles, each bottle containing 30 tablets with a cotton coiler and desiccant canister.
Danish: Tabletterne er pakket i HDPE flasker, hvor hver flaske indeholder 30 tabletter med vat og en tørrekapsel.
English: Microcrystalline cellulose Sucrose (as compressible sugar ) Crospovidone
Danish: Mikrokrystallinsk cellulose Sukrose (som sammentrykkeligt sukker) Crospovidone
English: Following the last dose administration, fluoxetine and norfluoxetine plasma levels declined steadily in a log-linear fashion.
Danish: Efter administration af den sidste dosis faldt fluoxetin- og norfluoxetinplasmaniveauerne støt på en log-lineær måde.
English: As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defaecation and/or urination) and only in combination with behavioural modification techniques.
Danish: Som en hjælp i behandlingen af separationsrelaterede lidelser hos hunde, der er manifesteret ved destruktion og upassende adfærd (vokalisation og upassende defækation og/eller urinering) og kun i kombination med modifikationsteknikker for adfærd.
English: The maximum plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) for fluoxetine were approximately dose proportional between 0.75 and 1.5 mg/kg, with a greater than dose proportional increase at 3 mg/kg.
Danish: Den maksimale plasmakoncentration (Cmax) og arealet under plasmakoncentrationstidskurven (AUC) for fluoxetin var næsten proportional med dosis mellem 0,75 og 1,5 mg/kg, med en større end dosisproportional øgning ved 3 mg/kg.
English: As an aid in the treatment of separation-related disorders in dogs, such as destruction and vocalisation and inappropriate defaecation and/or urination.
Danish: Anvendes som en hjælp i behandlingen af separationsrelaterede lidelser hos hunde, såsom destruktion og vokalisation og upassende defækation og/eller urinering.
English: As a result of inhibiting serotonin uptake, fluoxetine enhances serotonergic neurotransmission and produces functional effects resulting from increased activation of serotonin receptors.
Danish: Som et resultat af at hæmme serotoninoptagelse forstærker fluoxetin serotonerg neurotransmission og frembringer funktionelle virkninger, der skyldes øget aktivering af serotoninreceptorer.
English: Fluoxetine is largely metabolised by the liver.
Danish: Fluoxetin metaboliseres hovedsageligt i leveren.
English: Discard any tablets remaining in the container after the shelf life has expired.
Danish: Kassér alle tabletter, der er tilbage i beholderen efter opbevaringstiden er udløbet.
English: - Panting, seizures, vomiting (rare).
Danish: - Stønnen, krampeanfald, opkastning (sjældne).
English: At doses in excess of the recommended dose, observed side effects at the therapeutic dose, including seizures, are exacerbated.
Danish: Ved doseringer udover den anbefalede dosis forværres observerede bivirkninger ved den terapeutiske dosis, inklusive krampeanfald.
English: A 6-week washout interval should be observed following discontinuation of therapy with the product prior to the administration of any veterinary medicinal product that may adversely interact with fluoxetine or its metabolite, norfluoxetine.
Danish: Der bør overholdes et 6 ugers udvaskningsinterval efter afbrydelse af behandling med produktet forud for indgivelse af et andet veterinærlægemiddel, der på uheldig måde kan interagere med fluoxetin eller dets metabolit, norfluoxetin.
English: Fluoxetine and its active metabolite nor-fluoxetine have been shown to be highly selective inhibitors of serotonin uptake both in vitro and in vivo.
Danish: Fluoxetin og dets aktive metabolit nor-fluoxetin har vist sig at være yderst selektive hæmmere af serotoninoptagelse både in vitro og in vivo.
English: Speckled, tan to brown round chewable tablets, embossed on one side with a number (as listed below):
Danish: Plettede, lysebrune til brune runde tygbare tabletter, påtrykt på den ene side med et nummer (som angivet nedenfor):
English: Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, foetotoxic or maternotoxic effect.
Danish: Laboratorieundersøgelser af rotter og kaniner har ikke afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: Fluoxetine is metabolised to norfluoxetine, an equipotent SSRI that contributes to the efficacy of the veterinary medicinal product.
Danish: Fluoxetin metaboliseres til norfluoxetin, en ækvipotent SSRI, der medvirker til veterinærlægemidlets virkning.
English: No effect on the reproductive capacity in male and female rats was noted.
Danish: Der blev ikke bemærket nogen virkning på den reproduktive kapacitet hos han- og hunrotter.
English: In a 21 day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/kg body weight to laboratory Beagles.
Danish: I en 21 dages undersøgelse blev fluoxetin givet daglig ved en dosis på 0,75, 1,5 og 3,0 mg/kg legemsvægt til laboratoriebeagles.
English: The safety of Reconcile has not been established in dogs less than 6 months of age or weighing less than 4 kg.
Danish: Sikkerheden ved Reconcile er ikke blevet fastlagt hos hunde, der er under 6 måneder gamle og vejer mindre end 4 kg.
English: - Decreased appetite (including anorexia); lethargy (very common).
Danish: - Nedsat appetit (inklusive anoreksi); apati (meget almindelige).
English: - Weight loss/loss of condition; mydriasis (uncommon).
Danish: - Vægttab/konditionstab; mydriasis (ikke almindelige).
English: Norfluoxetine plasma levels slowly appeared in plasma and were slowly eliminated with t½ values ranging from 44.2 to 48.9 hours on day 21.
Danish: Norfluoxetin plasmaniveauer fremkom langsomt i plasma og blev langsomt udskilt med t½-værdier, der strakte sig fra 44,2 til 48,9 timer på dag 21.
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) - 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: Date of first authorisation: 08.07.2008 Date of last renewal: 13/07/2018
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13.07.2018
English: In cases of accidental overdose your veterinary surgeon should be consulted immediately and symptomatic therapy should be initiated.
Danish: I tilfælde af overdosering ved et uheld bør De kontakte dyrlægen med det samme, og symptomatisk behandling bør indledes.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation, thus the use is not recommended during pregnancy and lactation.
Danish: Veterinærægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt, hvorfor anvendelse under drægtighed og laktation frarådes.
English: - 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) - 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: Do not store above 30 °C.
Danish: Må ikke opbevares over 30oC.
English: Chewable tablet.
Danish: Tygbar tablet.
English: - Urinary tract disorders (cystitis, urinary incontinence, urinary retention, stranguria); central nervous system signs (incoordination, disorientation) (common).
Danish: - Urinvejslidelser (cystit, urininkontinens, urinretention, stranguri); tegn i centralnervesystemet (inkoordination, desorientering) (almindelige).
English: Plasma levels readily declined with mean t½ values ranging from 4.6 to 5.7 hours on day 1 and from 5.1 to 10.1 hours on day 21.
Danish: Plasmaniveauer faldt hurtigt med middel t½---værdier, der strakte sig fra 4,6 til 5,7 timer på dag 1 og fra 5,1 til 10,1 timer på dag 21.
English: Do not use in dogs weighing less than 4 kg.
Danish: Må ikke anvendes til hunde, der vejer under 4 kg.
English: Do not use the product in conjunction with other serotonergic agents (e.g. sertraline) and monoamine oxidase inhibitors (MAOIs) [e.g., selegiline hydrochloride (L-deprenyl), amitraz] or tricyclic amines (TCAs) (e.g. amitriptyline and clomipramine).
Danish: Produktet må ikke anvendes i forbindelse med andre serotonerge midler (f.eks. sertralin) og monoaminoxidasehæmmere (MAO-hæmmere) [f.eks. selegilinhydroklorid (L-deprenyl), amitraz] eller tricykliske aminer (TCA'er) (f.eks. amitriptylin og clomipramin).
English: Fluoxetine inhibits catecholamine uptake only at high concentrations in vitro and has no effect on catecholamine uptake in vivo at doses that are used to inhibit serotonin uptake.
Danish: Fluoxetin hæmmer kun katekolaminoptagelse ved høje koncentrationer in vitro og har ingen virkning på katekolaminoptagelse in vivo ved doseringer, der anvendes til at hæmme serotoninoptagelse.
English: After administration, fluoxetine readily appeared in plasma with mean Tmax values ranging from 1.25 to 1.75 hours on day 1 and from 2.5 to 2.75 hours on day 21.
Danish: Efter administration forekom fluoxetin hurtigt i plasma med middel Tmax-værdier, der strakte sig fra 1,25 til 1,75 timer på dag 1 og fra 2,5 til 2,75 timer på dag 21.