natgillin/translations-raw huggingface dataset:
Effekten af oral kontraception kan være nedsat, selvom der ikke observeres gennembrudsblødning.
Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.
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.
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.
Opsummering af resultater fra supplerende kliniske farmakokinetiske interaktionsstudier
Summary of Results from Additional Clinical Pharmacokinetic Drug Interaction Studies
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).
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).
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.
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.
• Blødende gummer
• Bleeding gums
Seks metabolitter, dannet ved hydroxylering, hydrolyse og glukuronidering, er isoleret, karakteriseret og identificeret fra human plasma, urin og fæces.
Six metabolites, formed through hydroxylation, hydrolysis and glucuronidation, have been isolated, characterized and identified from plasma, urine and faeces of humans.
Samlet var antallet af føtale misdannelser hos mus øget for alle de lægemiddelbehandlede grupper (20, 100 og 500 mg/kg/døgn).
Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
Efter en drøftelse af denne indikations ordlyd blev følgende tekst betragtet som acceptabel for CHMP, hvad angår brugen af topiramat som monoterapi af epilepsi:
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:
Tal med lægen eller apoteket, inden du tager Topimax, hvis du:
Check with your doctor or pharmacist before taking Topamax if you:
Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Frankrig
Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France
• Forstyrret eller dårlig søvn
• Disturbed or poor quality sleep
Tal med din læge, hvis din menstruationsblødning ændrer sig, mens du tager p-piller og Topimax.
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topamax.
41470 Neuss, Tyskland
41470 Neuss, Germany
Dette bør gøres ved titrering til klinisk effekt.
This should be done by titrating to clinical effect.
Der sås minimale ændringer i farmakokinetikken af den aktive totale substans (risperidon plus 9-hydroxyrisperidon) og ingen ændringer for 9-hydroxyrisperidon.
Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
Desuden var der ikke nogen ændring i steady-state plasmakoncentrationen af topiramat under og efter seponering af lamotriginbehandlingen (gennemsnitlig døgndosis 327 mg).
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).
Det anbefales, at Topimax ikke anvendes sammen med alkohol eller andre CNS-supprimerende lægemidler.
It is recommended that Topamax not be used concomitantly with alcohol or other CNS depressant medicinal products.
Forhøjet intraokulært tryk af enhver art kan, hvis ubehandlet, medføre alvorlige sequelae, herunder permanent synstab.
Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Der er rapporteret tilfælde af overdosering med topiramat.
Overdoses of topiramate have been reported.
Personer med kendt nedsat nyrefunktion kan kræve længere tid for at nå steady-state efter hver dosis.
Subjects with known renal impairment may require a longer time to reach steady-state at each dose
Topiramat udviser lav variation i plasmakoncentrationer mellem forsøgspersoner og har derfor en forudsigelig farmakokinetik.
Topiramate exhibits low intersubject variability in plasma concentrations and, therefore, has predictable pharmacokinetics.
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).
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).
Størstedelen af bivirkningerne var milde til moderate.
The majority of ADRs were mild to moderate in severity.
Efter omfattende drøftelser af brugen af topiramat som migræneprofylakse blev følgende tekst anset for acceptabel for CHMP:
Following extensive discussion on the use of topiramate in the prophylaxis of migraine, the following text was considered to be acceptable to the CHMP:
Kronisk metabolisk acidose øger risikoen for dannelsen af nyresten og kan potentielt føre til osteopeni.
Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia.
Afhængigt af den tilgrundliggende sygdom anbefales passende evaluering (inklusive serumhydrogencarbonatniveau) ved topiramatbehandling.
Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy.
En øget forekomst af humørsvingninger og depressioner er observeret ved behandling med topiramat.
An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Topiramats orale clearance synes at blive reduceret, når det administreres sammen med metformin.
Oral plasma clearance of topiramate appears to be reduced when administered with metformin.
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.
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.
↔ = ingen effekt på plasmakoncentration (≤ 15% ændring) ** = Plasmakoncentration øges hos nogle patienter ↓ = Plasmakoncentration falder NS = Ikke undersøgt
↔ = No effect on plasma concentration (≤ 15% change) ** = Plasma concentrations increase in individual patients ↓ = Plasma concentrations decrease NS = Not studied
I en serie af in vitro og in vivo mutagenicitetsundersøgelser viste topiramat ikke genotoksisk potentiale.
In a battery of in vitro and in vivo mutagenicity assays, topiramate did not show genotoxic potential.
Samtidig administration af topiramat og valproat er blevet i forbindelse med hyperammoniæmi med eller uden encefalopati hos patienter, der har tolereret begge lægemidler alene.
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.
↔ 20% øget Cmax og AUC for nortriptylinmetabolit
↔ 20% increase in Cmax and AUC of nortriptyline metabolite
• 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
• 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
En meta-analyse af randomiserede, placebokontrollerede forsøg med antiepileptisk medicin har vist en svagt øget risiko for selvmordstanker og suicidal opførsel.
A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal ideation and behaviour.
Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo Norge
Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo Norway
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.
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.
8 41470 Neuss, Tyskland
8 41470 Neuss, Germany
I kliniske forsøg med børn blev topiramat seponeret gradvist over 2-8 uger.
In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
Hammerbakken 19, 3460 Birkerød, Danmark
Hammerbakken 19, 3460 Birkerød, Denmark
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.
Although not achieving statistical significance in a given paediatric age group, the general trend is toward numerical superiority to placebo in each age group.
• Hallucinationer
• Hallucinations
- SI Smartinska cesta 53, 1000 Ljubljana, Slovenien
- SI Smartinska cesta 53, 1000 Ljubljana, Slovenia
Du skal også tale med din læge, før du tager anden medicin, der indeholder topiramat, og som du får i stedet for Topimax.
You should also to talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topamax.
Rigelig væskeindtagelse før og under aktiviteter såsom motion og udsættelse for varme temperaturer kan nedsætte risikoen for varmerelaterede bivirkninger (se pkt.
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).
Hos den voksne population viste doser af topiramat på 100 mg eller derover større reduktion i månedlige migræneanfald end placebo.
In the adult population, topiramate at doses equal to or higher than 100 mg showed greater reductions in monthly migraine attacks than placebo.
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.
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.
Patienter (og deres støttepersoner) bør instrueres i at søge medicinsk bistand, hvis tegn på selvmordstanker og suicidal adfærd opstår.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Lithiumniveauerne bør monitoreres ved samtidig behandling med topiramat.
Lithium levels should be monitored when co-administered with topiramate.
• Unormale blodtal, f.eks. nedsat antal hvide blodlegemer eller blodplader eller øget antal eosinofile blodlegemer
• Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
I prækliniske undersøgelser er topiramat vist at have teratogen effekt hos den undersøgte dyreart (mus, rotter og kaniner).
In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits).
Bivirkninger, hvor hyppigheden ikke er kendt.
Side effects of unknown frequency
Hæmodialyse er vist at være en effektiv metode til at fjerne topiramat fra kroppen.
Haemodialysis has been shown to be an effective means of removing topiramate from the body.
Topiramat er klassificeret som et sulfamatsubstitueret monosaccharid.
Topiramate is classified as a sulfamate-substituted monosaccharide.
Topiramatkoncentrationa
Topiramate Concentrationa
Drik et glas vand straks efter for at sikre, at hele blandingen synkes.
Drink fluids immediately in order to make sure all of the mixture is swallowed.
Topiramat er kun svagt effektivt ved blokering af kloniske krampeanfald induceret af GABAA-receptorantagonisten pentylentetrazol.
Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole.
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.
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).
Monoterapi af epilepsi hos børn og voksne
Monotherapy for epilepsy in children and adults
I kliniske studier var der ingen konsistent sammenhæng mellem plasmakoncentration og effekt eller bivirkninger.
In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.
CHMP er af den opfattelse, at kontraindikationen for brugen af topiramat til indikationen migræneprofylakse hos gravide og fertile kvinder uden passende kontraception er berettiget, eftersom topiramats teratogenicitet er påvist hos tre dyrearter, og eftersom der eksisterer alternative akutte behandlinger og profylaksebehandlinger af migræne under graviditeten, som ikke har vist sig at være teratogene hos tre dyrearter.
The CHMP is of the view that the contraindication for the use of topiramate for the indication of migraine prophylaxis during pregnancy and in women of child bearing potential without adequate contraception is justified based on the demonstration of teratogenicity of topiramate in three animal species and the availability of alternative acute and prophylactic treatments for migraine during pregnancy that have not been shown to be teratogenic in three animal species.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Topiramat er et sulfamatsubstitueret monosaccharid.
Topiramate is a sulfamate-substituted monosaccharide.
Hos de kvinder, der kræver profylaksebehandling ved migræne, foretrækkes et stof, som ved lave doser har vist sig ikke at være teratogent hos tre dyrearter.
In those women who require prophylactic treatment for migraine, an agent not shown to be teratogenic in three animal species at low dose, is preferred.
Indehaveren af markedsføringstilladelsen var uenig i dette forslag og anførte, at det i alle undersøgelserne ikke forlangtes af patienterne, at de ikke havde responderet på migræneforebyggende lægemidler.
The MAH disagreed with this proposal stating that in all trials, patients were not required to have failed on prophylactic migraine medications.
Nogle patienter, specielt de der er prædisponerede for nefrolithiasis, kan have en øget risiko for nyrestensdannelse og associerede symptomer som nyrekolik, nyresmerter eller flankesmerter.
Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Under behandling med Topimax bør lægemidler som disse undgås, da de kan danne et fysiologisk miljø, der øger risikoen for dannelse af nyresten.
While using Topamax, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation.
Overdosering med topiramat kan medføre alvorlig metabolisk acidose (se pkt.
Topiramate overdose can result in severe metabolic acidosis (see section 4.4).
Et effektivt dosisinterval på 200-400 mg om dagen til voksne blev godkendt af CHMP.
An effective dose range of 200-400mg/day for adults was endorsed by the CHMP.
De hyppigst rapporterede bivirkninger, når topiramat blev føjet til risperidon behandling, var: døsighed (27% og 12%), paræstesier (22% og 0%) og kvalme (18% og 9% respektivt).
The most frequently reported AE's when topiramate was added to risperidone treatment were: somnolence (27% and 12%), paraesthesia (22% and 0%) and nausea (18% and 9% respectively).
Aktionspotentialer, som er fremkaldt af vedvarende depolarisering af neuroner, blokeres af topiramat på en tidsafhængig måde, hvilket indikerer en tilstandsafhængig blokade af natriumkanaler.
Action potentials elicited repetitively by a sustained depolarization of the neurons were blocked by topiramate in a time-dependent manner, suggestive of a state-dependent sodium channel blocking action.
Den hårde kapsel er fremstillet til patienter, der ikke kan synke hele tabletter, fx børn og ældre.
The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly.
Tilstande eller behandlinger, der disponerer for acidose (som nyresygdom, alvorlige respiratoriske tilstande, status epilepticus, diaré, operation, ketogen diæt eller visse lægemidler) kan virke additivt til topiramats nedsættelse af hydrogencarbonatkoncentrationen.
Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products) may be additive to the bicarbonate lowering effects of topiramate.
Interaktioner med andre lægemidler
Other medicinal product interactions
• Øget syreindhold i blodet
• Increased acid levels in the blood
Topiramat skal gives med forsigtighed til patienter med tilstande eller behandlinger, der repræsenterer en risikofaktor for metabolisk acidose.
Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis.
I rotter passerer topiramat placentabarrieren.
In rats, topiramate crosses the placental barrier.
Disse bivirkninger kan potentielt medføre farlige situationer for patienter i trafikken eller under arbejde med maskiner, specielt indtil patienterne er bekendt med, hvordan lægemidlet virker på dem.
These adverse reactions could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with the medicinal products established.
Selv om der ikke opnås statistisk signifikans i en given aldersgruppe (2-5 år, 6-9 år, 10-15 år og ≥16 år), er den generelle tendens, at tallet for topiramat overstiger tallet for placebo i hver aldersgruppe.
Although not achieving statistical significance in a given age group 2-5 yrs, 6-9 yrs, 10-15 yrs and ≥16 yrs, the general trend is toward numerical superiority to placebo in each age group.
Det er ikke nødvendigt at monitorere plasmakoncentrationen af topiramat for at optimere behandlingen med Topimax.
It is not necessary to monitor topiramate plasma concentrations to optimize therapy with Topamax.
Som for andre antiepileptika kan nogle patienter opleve en øget anfaldsfrekvens eller start af nye typer af anfald ved brug af topiramat.
As with other anti-epileptic drugs, some patients may experience an increase in seizure frequency or the onset of new types of seizures with topiramate.
Sammenligning af topiramats farmakokinetiske profil med andre antiepileptika viser en lang plasmahalveringstid, lineær farmakokinektik, overvejende renal clearance, ubetydelig proteinbinding samt fravær af klinisk relevante aktive metabolitter.
The pharmacokinetic profile of topiramate compared to other antiepileptic drugs shows a long plasma halflife, linear pharmacokinetics, predominantly renal clearance, absence of significant protein binding, and lack of clinically relevant active metabolites.
Evidensen for topiramats virkning og sikkerhed som monoterapi ved behandling af epilepsi bygger på 4 randomiserede, kontrollerede undersøgelser.
The evidence of the efficacy and safety of topiramate as monotherapy in the treatment of epilepsy has been presented from 4 randomised controlled studies.
Hvis du snart skal tage den næste dosis, så spring den glemte dosis over og fortsæt blot med den sædvanlige dosis.
However, if it is almost time for your next dose, skip the missed dose and continue as usual.
I situationer, hvor topiramat af medicinske grunde skal seponeres hurtigt, anbefales passende monitorering (se pkt.
In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
• til at forebygge migræneanfald hos voksne.
• to prevent migraine headaches in adults
Studier med mus ved samtidig administration af topiramat og carbamazepin eller phenobarbital viste synergistisk antikonvulsiv aktivitet, hvorimod kombination med phenytoin viste additiv antikonvulsiv aktivitet.
Studies in mice receiving concomitant administration of topiramate and carbamazepine or phenobarbital showed synergistic anticonvulsant activity, while combination with phenytoin showed additive anticonvulsant activity.
Bradykardi, sinusbradykardi, palpitationer
Bradycardia, sinus bradycardia, palpitations
Der er blevet observeret en lav bindingskapacitet af topiramat i/på erytrocytter, som er mættet ved plasmakoncentrationer over 4 μg/ml.
A low capacity binding site for topiramate in/on erythrocytes that is saturable above plasma concentrations of 4 µg/ml has been observed.
Topiramat virker på centralnervesystemet og kan medføre sløvhed, svimmelhed eller andre tilsvarende symptomer.
Topiramate acts on the central nervous system and may produce drowsiness, dizziness or other related symptoms.
Bivirkninger, der er set i kliniske forsøg og efter markedsføringen (indikeret med *) er i tabel 1 listet efter hyppighed i de kliniske forsøg.
ADRs identified in clinical trials, and during post-marketing experience (as indicated by “*”) are listed by their incidence in clinical trials in Table 1.
Partielle anfald med eller uden sekundær generalisering hos voksne og børn Resultaterne af 6 kontrollerede undersøgelser viser, at tillægsbehandling med topiramat hos voksne har betydelige terapeutiske fordele, når det gælder kontrollen af partielle anfald med eller uden sekundær generalisering.
Partial onset seizures (POS) with or without secondary generalization in Adults and Children The results of 6 controlled studies indicate that adjunctive therapy in adults with topiramate has significant therapeutic benefit in controlling partial onset seizures with or without secondary generalisation.
Andre lægemidler, som du bør tale med din læge eller apoteket om, er anden antiepileptisk medicin, risperidon, lithium, hydrochlorthiazid, metformin, pioglitazon, glibenclamid, amitriptylin, propranolol, diltiazem, venlafaxin og flunarizin.
Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine
Tilstrækkelig hydrering er meget vigtig ved topiramatbehandling.
Adequate hydration while using topiramate is very important.
Topimax (topiramat) bør ikke anvendes til forebyggelse af migræne hos børn pga. manglende dukumentation for sikkerhed og virkning.
Topamax (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy.