FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic metabolic acidosis in paediatric patients can reduce growth rates.
Danish: Kronisk metabolisk acidose hos børn kan reducere væksthastigheden.
English: Topiramate is not intended for acute treatment.
Danish: Topiramat er ikke indiceret til akut behandling.
English: The recommended total daily dose of approximately 5 - 9 mg/kg/day in two divided doses as adjunctive therapy in the paediatric population (children aged 2 years and above) was endorsed by the CHMP.
Danish: Den anbefalede totale daglige dosis på ca. 5-9 mg/kg/dag fordelt på to separate doser som tillægsbehandling hos den pædiatriske population (børn over 2 år) blev godkendt af CHMP.
English: ≥1/10,000 to <1/1,000
Danish: ≥1/10.000 til <1/1.000
English: Although there was a dose dependent decrease in EE exposure for doses between 200-800 mg/day (in epilepsy patients), there was no significant dose dependent change in EE exposure for doses of 50-200 mg/day (in healthy volunteers).
Danish: Selvom der sås et dosisafhængigt fald i EE for doser mellem 200-800 mg/døgn (hos epilepsipatienter), var der ikke nogen signifikant dosisafhængig ændring i EE for doser mellem 50-200 mg/døgn (hos raske forsøgspersoner).
English: This has been reported with topiramate monotherapy and topiramate as part of a polytherapy regimen.
Danish: Dette er rapporteret både med topiramat som monoterapi og ved brug af topiramat som en del af et polyfarmaciregime.
English: Buckinghamshire HP 14 4HJ United Kingdom
Danish: Buckinghamshire HP 14 4HJ Storbritannien
English: Sometimes the dose of some of your other medicines or Topamax will have to be adjusted.
Danish: Nogle gange er det nødvendigt at justerer dosis af den anden medicin eller af Topimax.
English: “Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
Danish: “Topiramat er indiceret til migræneprofylakse hos voksne efter en nøje vurdering af alternative behandlingsmuligheder.
English: The pharmacokinetics of topiramate are linear with plasma clearance remaining constant and area under the plasma concentration curve increasing in a dose-proportional manner over a 100 to 400 mg single oral dose range in healthy subjects.
Danish: Farmakokinetikken for topiramat er lineær, således at plasmaclearance forbliver konstant, og arealet under plasmakoncentrationskurven stiger proportionalt med dosis over et område på 100-400 mg hos raske forsøgspersoner ved enkel oral dosis.
English: The active substance is topiramate.
Danish: Aktivt stof: Topiramat.
English: Additional pharmacokinetic drug interaction studies
Danish: Supplerende farmakokinetiske interaktionsstudier:
English: Hard capsules [To be completed nationally]
Danish: Hårde kapsler [Udfyldes nationalt]
English: Nausea, diarrhoea
Danish: Kvalme, diare
English: These decreases are usually mild to moderate (average decrease of 4 mmol/l at doses of 100 mg/day or above in adults and at approximately 6 mg/kg/day in paediatric patients).
Danish: Det er sædvanligvis mildt til moderat (gennemsnitlig fald på 4 mmol/l ved doser på 100 mg/døgn eller der over hos voksne og på ca. 6 mg/kg/døgn hos børn).
English: • Problems with learning
Danish: • Indlæringsproblemer
English: A determination should be made whether patients with history of eye disorders should be treated with topiramate.
Danish: Det skal vurderes, om patienter med øjenlidelser i anamnesen bør behandles med topiramat.
English: Therefore the CHMP considered that the use of topiramate as adjunctive therapy in adults with partial onset seizures with or without secondary generalization is supported.
Danish: Derfor var CHMP af den opfattelse, at brugen af topiramat som tillægsbehandling hos voksne med partielle anfald med eller uden sekundær generalisering er underbygget.
English: ≥1/1,000 to <1/100
Danish: ≥1/1.000 til <1/100
English: Your doctor will usually start you on a low dose of Topamax and slowly increase your dose until the best dose is found for you.
Danish: Lægen vil tit starte med at give dig en lav dosis og langsomt øge dosis til den dosis, som bedst får dine anfald under kontrol.
English: Drink fluids right after to make sure all of the food and medicine mixture is swallowed.
Danish: Drik et glas vand lige efter for at sikre, at al mad og medicin synkes.
English: Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, Denmark
Danish: Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, Danmark
English: Whether topiramate can exert some effect on bones (i.e. apart from that described for metabolic acidosis) and as a consequence on growth, has not been fully elucidated.
Danish: Det er endnu ikke fuldstændig klart, om topiramat kan påvirke knoglerne (bortset fra bivirkningerne i forbindelse med metabolisk acidose) og dermed væksten.
English: General dosing recommendations for Topamax in special patient populations
Danish: Generelle doseringsanbefalinger for Topimax i særlige patient populationer
English: In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults.
Danish: I modsætning til primært snævervinklet glaukom, der er usædvanligt under 40-års alderen, har sekundært akut snævervinklet glaukom i forbindelse med topiramat været rapporteret hos både børn og voksne.
English: As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topamax is used during pregnancy.
Danish: Som med andre antiepileptika er der en risiko for fosterskade, hvis Topimax bruges under graviditet.
English: Dihydroergotamine (Oral and Subcutaneous) Haloperidol
Danish: Dihydroergotamin (oral and subkutant)
English: There would appear to be both a clinically and statistically significant evidence of efficacy with topiramate as add-on treatment to commonly used AEDs in POS indications.
Danish: Der lader til at være både klinisk og statistisk signifikant evidens for virkningen af topiramat som tillægsbehandling til almindeligt brugte AED'er ved partielle anfaldsindikationer.
English: Hypokalaemia, increased appetite, polydipsia
Danish: Metabolisk acidose, hypokalæmia, øget appetit, polydipsi
English: Warning statements have also been included that topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis and also that the patient's history of eye disorders should be considered when treated with topiramate.
Danish: Der er ligeledes medtaget advarsler om, at topiramat bør bruges med forsigtighed hos patienter, der lider af sygdomme eller modtager behandlinger, som udgør en risikofaktor for forekomsten af metabolisk acidose, og at der bør tages højde for patienters tidligere øjensygdomme ved behandlingen med topiramat.
English: In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when given as adjunctive therapy in epilepsy patients taking valproic acid.
Danish: I et andet studie var AUC for EE statistisk signifikant nedsat ved doser på 200, 400 og 800 mg topiramat daglig (hhv. 18%, 21% og 30%), når det blev givet som adjuverende behandling til epilepsipatienter, der samtidig fik valproat.
English: Face oedema, calcinosis
Danish: Ødem i ansigtet, calcinosis
English: It is recommended that patients on topiramate treatment should be monitored for weight loss.
Danish: Det anbefales, at patienter i topiramat behandling kontrolleres for vægttab.
English: A suitable warning to the effect that the possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax has been included and is supported by the CHMP.
Danish: En passende advarsel om, at muligheden for nedsat kontraceptionsvirkning og hyppigere gennembrudsblødninger bør overvejes for patienter, der tager oral kontraception (kombinationsprodukter) sammen med Topimax, er blevet medtaget og støttes af CHMP.
English: • Pain in the kidney area and/or bladder caused by kidney stones
Danish: • Smerter i nyreområdet og/eller blæren pga. nyresten
English: • other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g.
Danish: • anden medicin, der forringer eller nedsætter din dømmekraft, koncentration eller koordinations evne (f. eks. medicin, der svækker centralnervesystemet, såsom muskelafslappende midler og sovemedicin).
English: It is recommended that therapy be initiated at a low dose followed by titration to an effective dose.
Danish: Det anbefales at opstarte behandlingen med lave doser for derefter at titrere til optimal dosis.
English: Mood disturbances/depression and suicidal tendency, acute myopia and secondary angle closure glaucoma and metabolic acidosis have been included and identified as an important risk in the Risk Management Plan (RMP).
Danish: 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Humørsvingninger/depression og selvmordstanker, akut myopi, snævervinklet glaukom og metabolisk acidose er blevet medtaget og identificeret som en vigtig risiko i risikostyringsplanen (RMP).
English: Examples are applesauce, custard, ice cream, porridge, pudding or yogurt.
Danish: Eksempler på blød føde er æblemos, budding, is, grød, dessert eller yoghurt.
English: In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose.
Danish: I kliniske undersøgelser var 200 mg den laveste effektive dosis som tillægsbehandling.
English: In both studies, Topamax (50-200 mg/day in healthy volunteers and 200-800 mg/day in epilepsy patients) did not significantly affect exposure to NET.
Danish: Begge studier med Topimax (50-200 mg/døgn hos raske forsøgspersoner og 200-800 mg/døgn hos epilepsipatienter) viste ingen signifikant påvirkning af NET.
English: Topiramate increased the frequency at which γ-aminobutyrate (GABA) activated GABAA receptors, and enhanced the ability of GABA to induce a flux of chloride ions into neurons, suggesting that topiramate potentiates the activity of this inhibitory neurotransmitter.
Danish: Topiramat forøgede hyppigheden, hvorved γ-aminobutyrat (GABA) aktiverede GABAA-receptorerne, og forøgede GABAs evne til at inducere en strøm af chloridioner ind i neuronerne.
English: Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
Danish: Topiramat er indiceret til forebyggelse af migræne hos voksne efter omhyggelig evaluering af alternative behandlingsmuligheder.
English: Topiramate enhances γ-aminobutyrate-activated chloride channels and inhibits excitatory neurotransmission, through actions on kainate subtypes of glutamate receptors and ∝-amino-3-hydroxy-5-methylisoxazole-4-propionic acid receptors.
Danish: Topiramat forstærker de γ-aminobutyrataktiverede chloridkanaler og hæmmer den excitatoriske neurotransmission ved at virke på kainat-undertyper af glutamatreceptorer og ∝-amino-3-hydroxy-5-methylisoxazol-4-propionsyre-receptorer.
English: The plasma and renal clearance of topiramate are decreased in patients with impaired renal function (CLCR ≤ 60 ml/min), and the plasma clearance is decreased in patients with end-stage renal disease.
Danish: Plasma og renal clearance af topiramat er nedsat hos patienter med nedsat nyrefunktion (kreatininclearance ≤ 60 ml/min) og plasmaclearance er nedsat hos patienter med terminal nyresygdom.
English: An association of hyperammonemia with topiramate monotherapy or concomitant treatment with other anti-epileptics has not been established.
Danish: En forbindelse mellem hyperammoniæmi og topiramatmonoterapi eller samtidig behandling med andre antiepileptika har ikke kunnet påvises.
English: In mice, fetal weights and skeletal ossification were reduced at 500 mg/kg/day in conjunction with maternal toxicity.
Danish: Hos mus var føtalvægt og skeletal ossifikation reduceret ved 500 mg/kg/døgn i forening med modertoksicitet.
English: The addition or withdrawal of valproic acid does not produce clinically significant changes in plasma concentrations of Topamax and, therefore, does not warrant dosage adjustment of Topamax.
Danish: Tillæg eller seponering af valproat giver ikke nogen klinisk relevant ændring i plasmakoncentrationen af Topimax, og dosisjustering af Topimax er derfor ikke nødvendig.
English: Topamax hard capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food.
Danish: Topimax hårde kapsler kan synkes hele eller åbnes forsigtigt og hele indholdet strøs ud på en lille mængde (en teskefuld) blød føde.
English: Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day.
Danish: Visse patienter med svært behandlelige (refraktære) former for epilepsi har tolereret doser på 1.000 mg/døgn ved topiramatmonoterapi.
English: Following administration of multiple doses of 50 mg and 100 mg of topiramate twice a day, the mean plasma elimination half-life was approximately 21 hours.
Danish: Efter gentaget administration af henholdsvis 50 mg og 100 mg topiramat 2 gange daglig var den gennemsnitlige plasmaeliminations halveringstid ca. 21 timer.
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
Danish: Ved vedvarende metabolisk acidose bør dosisreduktion eller seponering af topiramat overvejes (brug dosisnedtrapning).
English: It is also an inhibitor of some isozymes of carbonic anhydrase.
Danish: Det hæmmer ligeledes nogle isozymer af kulsyreanhydrase.
English: • Decreased or loss of hearing.
Danish: • Nedsat hørelse eller tab af hørelsen
English: Drug-drug interaction studies conducted under single dose conditions in healthy volunteers and multiple dose conditions in patients with bipolar disorder, yielded similar results.
Danish: Lægemiddelinteraktionsstudier gennemført som enkeltdosisforsøg hos raske forsøgspersoner og flerdosisforsøg hos patienter med bipolære lidelser gav samme resultat.
English: The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate.
Danish: Steady-state farmakokinetikken af hydrochlorthiazid blev ikke signifikant påvirket ved samtidig administration af topiramat.
English: In juvenile rats, daily oral administration of topiramate at doses up to 300 mg/kg/day during the period of development corresponding to infancy, childhood, and adolescence resulted in toxicities similar to those in adult animals (decreased food consumption with decreased body weight gain, centrolobullar hepatocellular hypertrophy).
Danish: Hos unge rotter resulterede daglig oral administration af topiramat i doser op til 300 mg/kg/døgn under udviklingsperioden, svarende til spædbarnsalder, barndom og ungdom, i toksicitet magen til den, der blev set hos voksne dyr (nedsat fødeindtagelse med nedsat øgning af legemsvægten, centrilobulær hepatocellulær hypertrofi).
English: You may find it best to do this over the small portion of food onto which you will be pouring the sprinkles.
Danish: Dette kan gøres over den mad, du vil strø medicinen ud over.
English: The clinical significance of the effect of topiramate on metformin pharmacokinetics is unclear.
Danish: Den kliniske betydning af topiramats virkning på metformins farmakokinetik er uklar.
English: A dietary supplement or increased food intake may be considered if the patient is losing weight while on topiramate.
Danish: Det kan være nødvendigt at give kosttilskud eller øge kostindtaget, hvis patienten taber sig under behandlingen med topiramat.
English: Following twice a day dosing with 50 mg and 100 mg of topiramate the mean renal clearance was approximately 18 ml/min and 17 ml/min, respectively.
Danish: Ved en dosering 2 gange daglig med 50 mg og 100 mg topiramat var den gennemsnitlige renale clearance henholdsvis 18 ml/min og 17 ml/min.
English: • Clumsiness, or problems with walking
Danish: • Klodsethed eller gangproblemer
English: This is seen to be supportive of the proposed indication of topimarate as adjunctive therapy for partial onset seizures with or without secondarily generalised seizures in the paediatric population.
Danish: Dette anses for at underbygge den foreslåede indikation for topimarat som tillægsbehandling ved partielle anfald med eller uden sekundær generalisering hos den pædiatriske population.
English: Stevens-Johnson syndrome* erythema multiforme*, skin odour abnormal, periorbital oedema*, urticaria localised
Danish: StevensJohnsons syndrom*, erythema multiforme*, unormal hudlugt, periorbital ødem*, lokal urticaria ,
English: Risperidone
Danish: Risperidon
English: • Localized swelling in the skin
Danish: • Lokaliseret hævelse i huden
English: 5.3 - Preclinical safety data
Danish: 5.3 - Prækliniske sikkerhedsdata
English: No dose adjustment is recommended for the elderly, provided that renal function is in tact.
Danish: Der anbefales ingen dosisjustering for ældre, såfremt nyrefunktionen er intakt.
English: Plasma clearance of topiramate is unchanged in elderly subjects in the absence of underlying renal disease.
Danish: Plasmaclearance af topiramat er uændret hos ældre patienter uden nyresygdom.
English: • Ringing sound in the ears
Danish: • Ringen for ørerne
English: Topiramate showed a reduction of PTGC seizures rate in the American/CR study, and when both studies were combined.
Danish: Topiramat viste en reduktion af hyppigheden for primært generaliserede tonisk-kloniske anfald i den undersøgelse, der blev foretaget i USA og Costa Rica, og når begge undersøgelser blev kombineret.
English: Regarding the posology for topiramate, in general the titration schedules in monotherapy and adjunct therapy in Section 4.2 Posology of the SPC are consistent across MS SPCs, although there are differences depending on age range for use.
Danish: Hvad angår doseringen af topiramat, er titreringsskemaerne ved monoterapi og tillægsbehandling i punkt "4.2 Dosering" i produktresuméet generelt de samme i alle medlemsstaternes produktresuméer, selv om der er forskelle i brugen alt efter aldersgruppe.
English: A 15% decrease in the AUCτ,ss of pioglitazone with no alteration in Cmax,ss was observed.
Danish: For pioglitazon blev der observeret et fald på 15% i AUCτ,ss, men ingen ændringer i Cmax,ss.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperaemia (redness) and increased intraocular pressure.
Danish: Oftalmologiske fund kan omfatte myopi, affladiget forkammer, okulær hyperæmi (rødme) og forøget intraokulært tryk.
English: If you stop taking Topamax
Danish: Hvis du holder op med at tage Topimax
English: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax.
Danish: Risikoen for nedsat effekt af oral kontraception og den øgede risiko for gennembrudsblødning skal tages i betragtning hos patienter, der tager kombinerede orale kontraceptiva og Topimax.
English: Animal studies have shown excretion of topiramate in milk.
Danish: Dyreforsøg har vist, at topiramat udskilles i modermælk.
English: High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Danish: High Wycombe Buckinghamshire HP14 4HJ Storbritannien
English: The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response.
Danish: Dosis bør derefter øges hver eller hver anden uge med en stigning på 1-3 mg/kg/døgn (fordelt på 2 doser) for at opnå det optimale kliniske respons.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Alu/alu blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Alu/alu blister
English: When concomitant antiepileptic drugs (AEDs) are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control.
Danish: Når samtidigt administrerede antiepileptika seponeres med henblik på monoterapi med topiramat bør der tages hensyn til den muligevirkning, dette kan have på anfaldskontrollen.
English: No study has shown that good migraine control prevents gestational hypertension or pre eclampsia.
Danish: Ingen undersøgelse har vist, at en god migrænekontrol forebygger svangerskabshypertension eller præeklampsi.
English: In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 µg ethinyl estradiol (EE), Topamax given in the absence of other medications at doses of 50 to 200 mg/day was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive.
Danish: I et farmakokinetisk interaktionsstudie med raske frivillige, som samtidig fik oral kontraception (kombinationsprodukt) med 1 mg norethisteron (NET) og 35 μg ethinylestradiol (EE) og Topimax i doser på 50-200 mg/døgn (som eneste andet lægemiddel), blev der ikke observeret statistisk signifikante ændringer i AUC for norethisteron eller ethinylestradiol.
English: A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity
Danish: • Raynauds syndrom, en lidelse, der påvirker blodkarrene i fingre, tæer og ører og forårsager smerte og kuldefølelse
English: On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome.
Danish: I sjældne tilfælde, hvor Topimax administreres som tillægsbehandling til phenytoin, kan det være nødvendigt at justere dosis af phenytoin for at opnå optimal klinisk effekt.
English: The studies showing an association between the occurrence of gestational hypertension or pre eclampsia more commonly in women with migraine do not prove a causal relationship between migraine and either pre eclampsia or hypertension.
Danish: De undersøgelser, der viser en forbindelse mellem den hyppigere forekomst af svangerskabshypertension eller præeklampsi hos kvinder med migræne, er ikke et bevis for en årsagssammenhæng mellem migræne og enten præeklampsi eller hypertension.
English: • Frequent urination
Danish: • Hyppig vandladning
English: In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis.
Danish: I kliniske forsøg nedtrappedes døgndosis med 50-100 mg om ugen hos voksne med epilepsi og med 25-50 mg om ugen hos voksne, der behandles med topiramat i doser op til 100 mg/døgn ved migræneprofylakse.
English: A contraindication for the use of topiramate for the indication of epilepsy in pregnancy and women of childbearing potential if not using effective methods of contraception was not considered warranted by the CHMP.
Danish: En kontraindikation for brugen af topiramat til indikationen epilepsi hos gravide og fertile kvinder, hvis ikke der anvendes effektive kontraceptionsmetoder, blev ikke betragtet som påkrævet af CHMP.
English: The mean Cmax following multiple, twice a day oral doses of 100 mg to healthy subjects was 6.76 µg/ml.
Danish: Den gennemsnitlige Cmax ved gentaget oral administration af 100 mg 2 gange daglig til raske forsøgspersoner var 6,76 μg/ml.
English: As in adults, hepatic enzyme inducing anti-epileptic drugs decrease the steady-state plasma concentrations.
Danish: Som hos voksne nedsætter andre enzyminducerende antiepileptika steadystate plasmakoncentrationerne af topiramat.
English: If you forget to take Topamax
Danish: Hvis du har glemt at tage Topimax
English: ADRs that were reported in children but not in adults in double-blind controlled studies include: eosinophilia, psychomotor hyperactivity, vertigo, vomiting, hyperthermia, pyrexia, and learning disability.
Danish: Bivirkninger, som er rapporteret hos børn, men ikke hos voksne i dobbelt-blinde forsøg, inkluderer: eosinofili, psykomotorisk hyperaktivitet, vertigo, opkastning, hypertermi, feber og indlæringsvanskeligheder.