FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it is reasonable to accept that if efficacy in a given indication has been shown in the paediatric population in general, then those results can be extrapolated to a given lower age limit.
Danish: Hvis virkningen for en given indikation er blevet påvist i den pædiatriske population generelt, må det således med rimelighed antages, at disse resultater kan ekstrapoleres til en given lavere aldersgrænse.
English: Symptoms typically occur within 1 month of initiating topiramate therapy.
Danish: Symptomerne opstår typisk i løbet af første måned efter behandlingsstart.
English: - SI Šmartinska 53, Ljubljana, Slovenia
Danish: - SI Šmartinska 53, Ljubljana, Slovenien
English: The teratogenic effects seen in rats and rabbits were similar to those seen with carbonic anhydrase inhibitors, which have not been associated with malformations in humans.
Danish: De teratogene virkninger, der er set hos rotter og kaniner, er de samme, som er set for carbonanhydrasehæmmere, og som ikke har været associeret med misdannelser hos mennesker.
English: Phenytoin and carbamazepine decrease the plasma concentration of topimarate.
Danish: Phenytoin and carbamazepin reducerer plasmakoncentrationen af Topimax.
English: For the sake of consistency it was agreed to merge both adjunctive therapy indications to read:
Danish: For konsekvensens skyld blev det besluttet at samle begge tillægsbehandlingsindikationer som følger:
English: Consequently, any patient on phenytoin showing clinical signs or symptoms of toxicity should have phenytoin levels monitored.
Danish: Som en konsekvens heraf bør alle patienter i phenytoinbehandling, der udviser kliniske symptomer på toksicitet, have monitoreret phenytoinniveauet.
English: This explanation was considered to be reasonable and the proposed indication for the use of topiramate as adjunctive therapy in adults with primary generalized tonic-clonic seizures can be considered to be sufficiently supported.
Danish: Denne forklaring blev anset for at være fornuftig, og den foreslåede indikation for brugen af topiramat som tillægsbehandling hos voksne med primært generaliserede tonisk-kloniske anfald kan betragtes som tilstrækkeligt underbygget.
English: Systemic exposure of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), were also reduced by 13% and 15%, respectively.
Danish: Systemisk eksponering af de aktive metabolitter, 4-trans-hydroxyglibenclamid (M1) og 3-cis-hydroxyglibenclamid (M2) blev også reduceret med hhv. 13% og 15%.
English: Clinical studies have been conducted to assess the potential pharmacokinetic drug interaction between topiramate and other agents.
Danish: Kliniske studier er blevet udført for at vurdere den potentielle farmakokinetiske interaktion mellem topiramat og andre lægemidler.
English: In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3 fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated).
Danish: I dobbeltblindede kliniske undersøgelser forekom selvmordsrelaterede events (SREs) (selvmordstanker, selvmordsforsøg og selvmord) med en frekvens på 0,5% hos topiramatbehandlede patienter (46 ud af 8.652 behandlede patienter), hvilket er en næsten 3 gange højere frekvens end hos dem, der blev behandlet med placebo (0,2%; 8 ud af 4.045 behandlede patienter).
English: There is evidence of renal tubular reabsorption of topiramate.
Danish: Der er tegn på renal tubulær reabsorption af topiramat.
English: The results provided by this study reinforce those derived from the Study YP in children with Partial Onset Seizure.
Danish: Resultaterne af denne undersøgelse underbygger resultaterne af YP-undersøgelsen af børn med partielle anfald.
English: The extent of change in the clearance is unknown.
Danish: Det vides ikke, i hvilken udstrækning clearance ændres.
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Danish: Symptomerne omfatter akut synsnedsættelse og/eller okulære smerter.
English: The supplemental dose may differ based on the characteristics of the dialysis equipment being used.
Danish: Den supplerende dosis kan variere afhængigt af det anvendte dialyseudstyr.
English: Patients taking estrogen containing contraceptives should be asked to report any change in their bleeding patterns.
Danish: Patienter, der tager østrogenholdige kontraceptionspræparater, bør informeres om, at de skal rapportere alle ændringer i blødningsmønsteret.
English: Study TOPMAT-EPMN-105 provided evidence to support the extension to the wider ‘epilepsy' indication as this is the only study which included patients with a variety of seizure syndromes other than partial onset seizures.
Danish: TOPMAT-EPMN-105-undersøgelsen gav evidens til støtte for udvidelsen til at omfatte en bredere epilepsiindikation, eftersom det er den eneste undersøgelse, der omfattede patienter med forskellige andre anfaldssyndromer end partielle anfald.
English: In newly diagnosed patients, topiramate showed benefit in monotherapy in two (TOPMAT-EPMN-105 and TOPMAT-EPMN-106) out of the three studies conducted.
Danish: Hos nyligt diagnosticerede patienter viste topiramat en gavnlig virkning som monoterapi i to (TOPMAT-EPMN-105 og TOPMAT-EPMN-106) ud af de tre undersøgelser, der blev foretaget.
English: Oral contraceptives
Danish: Oral kontraception:
English: In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk.
Danish: Ydermere kan patienter, der er i behandling med andre lægemidler, som disponerer til nefrolithiasis, have en øget risiko.
English: • Involuntary shaking in the arms, hands or legs
Danish: • Ufrivillige rystelser i arme, hænder eller ben
English: A small number of people being treated with anti-epileptic medicines such as Topamax have had thoughts of harming or killing themselves.
Danish: Et lille antal personer, der har været behandlet med antiepileptisk medicin som Topimax, har haft tanker om at gøre skade på sig selv eller begå selvmord.
English: In some countries, topiramate was approved as a second- line prophylactic migraine medication.
Danish: I nogle lande blev topiramat godkendt som andetvalgs migræneforebyggende lægemiddel.
English: • Changes in mood or behaviour, including anger, nervousness, sadness
Danish: • Påvirkning af humør eller adfærd, f.eks. følelse af vrede, nervøsitet eller tristhed
English: • Sprinkle all of the capsule's contents onto a spoonful of soft food, taking care to see that the entire prescribed dosage is sprinkled onto the food.
Danish: • Strø hele kapselindholdet ud på en skefuld af den bløde mad, mens du er opmærksom på, at hele dosis kommer på maden.
English: Venlafaxine Flunarizine
Danish: Venlafaxin Flunarizin
English: • You may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.
Danish: • Du kan føle dig døsig eller træt, få unormale bevægelser eller problemer med at stå og gå, blive svimmel på grund af lavt blodtryk eller få unormal puls eller anfald.
English: In patients with or without a history of seizures or epilepsy, antiepileptic drugs including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
Danish: Hos patienter med eller uden anamnese med krampeanfald eller epilepsi bør antiepileptisk medicin inklusive topiramat gradvist seponeres for at minimere risikoen for anfald eller øget frekvens af anfald.
English: It is metabolized up to 50% in patients receiving concomitant antiepileptic therapy with known inducers of drug metabolizing enzymes.
Danish: Det metaboliseres op til 50% hos patienter, der samtidig får andre antiepileptika, som er kendt som enzyminducerende farmaka.
English: This is supported by studies in rats where topiramate was co-administered with probenecid, and a significant increase in renal clearance of topiramate was observed.
Danish: Dette understøttes af forsøg med rotter, hvor topiramat blev administreret sammen med probenecid, og der blev observeret en signifikant stigning i renal clearance af topiramat.
English: A total of 9 studies have been conducted and submitted in order to explore the efficacy of topiramate as add-on (adjunctive) therapy.
Danish: I alt 9 undersøgelser er blevet foretaget og indsendt for at undersøge topiramats virkning som tillægsbehandling.
English: There was no clinically significant effect of food on the bioavailability of topiramate.
Danish: Der var ingen klinisk signifikant effekt af fødeindtagelse på biotilgængeligheden af topiramat.
English: Assigned frequencies are as follows:
Danish: Hyppigheden er listet således:
English: Show this list to your doctor and pharmacist before you start a new medicine.
Danish: Vis listen til din læge og på apoteket, før du starter med at tage ny medicin.
English: Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.
Danish: Effekten af oral kontraception kan være nedsat, selvom der ikke observeres gennembrudsblødning.
English: In addition, a 13% and 16% decrease in Cmax,ss and AUCτ,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUCτ,ss of the active keto-metabolite.
Danish: Endvidere blev der observeret et fald på henholdsvis 13% og 16% i Cmax,ss og AUCτ,ss for den aktive hydroxymetabolit og et fald på 60% i Cmax,ss og AUCτ,ss for den aktive ketometabolit.
English: Summary of Results from Additional Clinical Pharmacokinetic Drug Interaction Studies
Danish: Opsummering af resultater fra supplerende kliniske farmakokinetiske interaktionsstudier
English: Appropriate advice has been included in section 4.6 about the risks to the mother and foetus of treatment and the risks of not treating epilepsy during pregnancy (see SPC section 4.6).
Danish: Passende oplysninger er medtaget i punkt 4.6 om behandlingens risici for moderen og fosteret og om de risici, der er forbundet med ikke at behandle epilepsi under graviditeten (se punkt 4.6 i produktresuméet).
English: There would appear to be a reduction in all measured parameters (Cmax, Tmax and AUC) for Ethinyl Estradiol associated with concomitant topiramate administration in the epilepsy study.
Danish: Det lader til, at der er en reduktion i alle målte parametre (Cmax, Tmax og AUC) for ethinylestradiol i forbindelse med samtidig indgivelse af topiramat i epilepsiundersøgelsen.
English: • Bleeding gums
Danish: • Blødende gummer
English: Six metabolites, formed through hydroxylation, hydrolysis and glucuronidation, have been isolated, characterized and identified from plasma, urine and faeces of humans.
Danish: Seks metabolitter, dannet ved hydroxylering, hydrolyse og glukuronidering, er isoleret, karakteriseret og identificeret fra human plasma, urin og fæces.
English: Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
Danish: Samlet var antallet af føtale misdannelser hos mus øget for alle de lægemiddelbehandlede grupper (20, 100 og 500 mg/kg/døgn).
English: After discussion of the wording for this indication, the following text was considered to be acceptable to the CHMP for the use of topiramate in monotherapy for epilepsy:
Danish: Efter en drøftelse af denne indikations ordlyd blev følgende tekst betragtet som acceptabel for CHMP, hvad angår brugen af topiramat som monoterapi af epilepsi:
English: Check with your doctor or pharmacist before taking Topamax if you:
Danish: Tal med lægen eller apoteket, inden du tager Topimax, hvis du:
English: Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France
Danish: Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Frankrig
English: • Disturbed or poor quality sleep
Danish: • Forstyrret eller dårlig søvn
English: Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topamax.
Danish: Tal med din læge, hvis din menstruationsblødning ændrer sig, mens du tager p-piller og Topimax.
English: 41470 Neuss, Germany
Danish: 41470 Neuss, Tyskland
English: This should be done by titrating to clinical effect.
Danish: Dette bør gøres ved titrering til klinisk effekt.
English: Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
Danish: Der sås minimale ændringer i farmakokinetikken af den aktive totale substans (risperidon plus 9-hydroxyrisperidon) og ingen ændringer for 9-hydroxyrisperidon.
English: In addition, there was no change in steady state plasma concentration of topiramate during or after removal of lamotrigine treatment (mean dose of 327 mg/day).
Danish: Desuden var der ikke nogen ændring i steady-state plasmakoncentrationen af topiramat under og efter seponering af lamotriginbehandlingen (gennemsnitlig døgndosis 327 mg).
English: It is recommended that Topamax not be used concomitantly with alcohol or other CNS depressant medicinal products.
Danish: Det anbefales, at Topimax ikke anvendes sammen med alkohol eller andre CNS-supprimerende lægemidler.
English: Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Danish: Forhøjet intraokulært tryk af enhver art kan, hvis ubehandlet, medføre alvorlige sequelae, herunder permanent synstab.
English: Overdoses of topiramate have been reported.
Danish: Der er rapporteret tilfælde af overdosering med topiramat.
English: Subjects with known renal impairment may require a longer time to reach steady-state at each dose
Danish: Personer med kendt nedsat nyrefunktion kan kræve længere tid for at nå steady-state efter hver dosis.
English: Topiramate exhibits low intersubject variability in plasma concentrations and, therefore, has predictable pharmacokinetics.
Danish: Topiramat udviser lav variation i plasmakoncentrationer mellem forsøgspersoner og har derfor en forudsigelig farmakokinetik.
English: Following oral administration of 100 mg topiramate to healthy subjects, a mean peak plasma concentration (Cmax) of 1.5 µg/ml was achieved within 2 to 3 hours (Tmax).
Danish: Efter oral administration af 100 mg topiramat til raske forsøgspersoner blev en gennemsnitlig peak plasmakoncentration (Cmax) på 1,5 μg/ml opnået inden for 2-3 timer (Tmax).
English: The majority of ADRs were mild to moderate in severity.
Danish: Størstedelen af bivirkningerne var milde til moderate.
English: Following extensive discussion on the use of topiramate in the prophylaxis of migraine, the following text was considered to be acceptable to the CHMP:
Danish: Efter omfattende drøftelser af brugen af topiramat som migræneprofylakse blev følgende tekst anset for acceptabel for CHMP:
English: Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia.
Danish: Kronisk metabolisk acidose øger risikoen for dannelsen af nyresten og kan potentielt føre til osteopeni.
English: Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy.
Danish: Afhængigt af den tilgrundliggende sygdom anbefales passende evaluering (inklusive serumhydrogencarbonatniveau) ved topiramatbehandling.
English: An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Danish: En øget forekomst af humørsvingninger og depressioner er observeret ved behandling med topiramat.
English: Oral plasma clearance of topiramate appears to be reduced when administered with metformin.
Danish: Topiramats orale clearance synes at blive reduceret, når det administreres sammen med metformin.
English: There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters.
Danish: Der var ingen relevant effekt på væksten af de lange knogler (tibia) eller mineraldensiteten af knoglerne (femur), den tidlige udvikling (før fravænning) og udviklingen af kønsorganer, den neurologisk udvikling (inklusive bedømmelse af hukommelse og indlæringsevne), parring og fertilitet eller hysterotomiparametre.
English: ↔ = No effect on plasma concentration (≤ 15% change) ** = Plasma concentrations increase in individual patients ↓ = Plasma concentrations decrease NS = Not studied
Danish: ↔ = ingen effekt på plasmakoncentration (≤ 15% ændring) ** = Plasmakoncentration øges hos nogle patienter ↓ = Plasmakoncentration falder NS = Ikke undersøgt
English: In a battery of in vitro and in vivo mutagenicity assays, topiramate did not show genotoxic potential.
Danish: I en serie af in vitro og in vivo mutagenicitetsundersøgelser viste topiramat ikke genotoksisk potentiale.
English: Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either medicinal product alone.
Danish: Samtidig administration af topiramat og valproat er blevet i forbindelse med hyperammoniæmi med eller uden encefalopati hos patienter, der har tolereret begge lægemidler alene.
English: ↔ 20% increase in Cmax and AUC of nortriptyline metabolite
Danish: ↔ 20% øget Cmax og AUC for nortriptylinmetabolit
English: • Severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, and erythma multiforme, a condition of raised red spots that can blister
Danish: • Alvorlige hudreaktioner f.eks. Stevens-Johnsons syndrom, en livstruende hudreaktion, hvor det øverste hudlag løsner sig fra det nederste, og erythema multiforme, en reaktion med hævede røde pletter, som kan danne blister
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal ideation and behaviour.
Danish: En meta-analyse af randomiserede, placebokontrollerede forsøg med antiepileptisk medicin har vist en svagt øget risiko for selvmordstanker og suicidal opførsel.
English: Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo Norway
Danish: Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo Norge
English: It has been noted that weight loss is a pertinent feature of treatment with topiramate in some patients and a warning stating that patients on long term topiramate treatment should be regularly weighed and monitored for continuing weight loss has been included.
Danish: Det er blevet bemærket, at vægttab er et relevant aspekt af behandlingen med topiramat hos nogle patienter, og en advarsel om, at patienter, der langtidsbehandles med topiramat, bør vejes regelmæssigt og overvåges for yderligere vægttab, er blevet medtaget.
English: 8 41470 Neuss, Germany
Danish: 8 41470 Neuss, Tyskland
English: In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
Danish: I kliniske forsøg med børn blev topiramat seponeret gradvist over 2-8 uger.
English: Hammerbakken 19, 3460 Birkerød, Denmark
Danish: Hammerbakken 19, 3460 Birkerød, Danmark
English: Although not achieving statistical significance in a given paediatric age group, the general trend is toward numerical superiority to placebo in each age group.
Danish: Selv om der ikke opnås statistisk signifikans i en given pædiatrisk aldersgruppe, er den generelle tendens, at tallet for topiramat overstiger tallet for placebo i hver aldersgruppe.
English: • Hallucinations
Danish: • Hallucinationer
English: - SI Smartinska cesta 53, 1000 Ljubljana, Slovenia
Danish: - SI Smartinska cesta 53, 1000 Ljubljana, Slovenien
English: You should also to talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topamax.
Danish: Du skal også tale med din læge, før du tager anden medicin, der indeholder topiramat, og som du får i stedet for Topimax.
English: Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8).
Danish: Rigelig væskeindtagelse før og under aktiviteter såsom motion og udsættelse for varme temperaturer kan nedsætte risikoen for varmerelaterede bivirkninger (se pkt.
English: In the adult population, topiramate at doses equal to or higher than 100 mg showed greater reductions in monthly migraine attacks than placebo.
Danish: Hos den voksne population viste doser af topiramat på 100 mg eller derover større reduktion i månedlige migræneanfald end placebo.
English: There does not appear to be any statistically significant difference between the plasma concentration of risperidone when administered concomitantly with topiramate either in healthy subjects or in patients with Bipolar Disorder.
Danish: Der lader ikke til at være nogen statistisk signifikant forskel på plasmakoncentrationen af risperidon, når det indgives samtidig med topiramat, hverken hos sunde forsøgspersoner eller hos patienter med bipolær lidelse.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og deres støttepersoner) bør instrueres i at søge medicinsk bistand, hvis tegn på selvmordstanker og suicidal adfærd opstår.
English: Lithium levels should be monitored when co-administered with topiramate.
Danish: Lithiumniveauerne bør monitoreres ved samtidig behandling med topiramat.
English: • Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
Danish: • Unormale blodtal, f.eks. nedsat antal hvide blodlegemer eller blodplader eller øget antal eosinofile blodlegemer
English: In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits).
Danish: I prækliniske undersøgelser er topiramat vist at have teratogen effekt hos den undersøgte dyreart (mus, rotter og kaniner).
English: Side effects of unknown frequency
Danish: Bivirkninger, hvor hyppigheden ikke er kendt.
English: Haemodialysis has been shown to be an effective means of removing topiramate from the body.
Danish: Hæmodialyse er vist at være en effektiv metode til at fjerne topiramat fra kroppen.
English: Topiramate is classified as a sulfamate-substituted monosaccharide.
Danish: Topiramat er klassificeret som et sulfamatsubstitueret monosaccharid.
English: Topiramate Concentrationa
Danish: Topiramatkoncentrationa
English: Drink fluids immediately in order to make sure all of the mixture is swallowed.
Danish: Drik et glas vand straks efter for at sikre, at hele blandingen synkes.
English: Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole.
Danish: Topiramat er kun svagt effektivt ved blokering af kloniske krampeanfald induceret af GABAA-receptorantagonisten pentylentetrazol.
English: Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (section 4.4).
Danish: Da mange lægemidler udskilles i modermælken, bør det besluttes, om amningen skal afbrydes eller topiramatbehandlingen seponeres, idet der samtidig skal tages højde for vigtigheden af lægemidlet for moderen (se pkt.
English: Monotherapy for epilepsy in children and adults
Danish: Monoterapi af epilepsi hos børn og voksne
English: In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.
Danish: I kliniske studier var der ingen konsistent sammenhæng mellem plasmakoncentration og effekt eller bivirkninger.