natgillin/translations-raw huggingface dataset:
Zonegran bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for zonisa - mid, over for andre af indholdsstofferne eller over for sulfonamider (en type antibiotika).
Zonegran should not be used in people who may be hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Zonegran opve - jer risiciene som tillægsbehandling hos voksne patienter med partielle anfald med eller uden sekundær generalisering.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zonegran’ s benefits are greater than its risks as adjunctive therapy in the treatment of adult patients with partial onset seizures, with or without secondary generalisation.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Zonegran.
The Committee recommended that Zonegran be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zonegran til Eisai Limited den 10. marts 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran to Eisai Limited on 10 March 2005.
Den fuldstændige EPAR om Zonegran findes her.
The full EPAR for Zonegran can be found here.
EU/ 1/ 04/ 307/ 001 EU/ 1/ 04/ 307/ 002 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 005 EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 010 EU/ 1/ 04/ 307/ 011 EU/ 1/ 04/ 307/ 012 EU/ 1/ 04/ 307/ 013
EU Number EU/ 1/ 04/ 307/ 001 EU/ 1/ 04/ 307/ 002 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 005 EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 010 EU/ 1/ 04/ 307/ 011 EU/ 1/ 04/ 307/ 012 EU/ 1/ 04/ 307/ 013
Særnavn Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran
Invented name Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran
Styrke 25 mg 25 mg 50 mg 100 mg 25 mg 100 mg 100 mg 100 mg 50 mg 50 mg 100 mg 50 mg 25 mg
Strength 25 mg 25 mg 50 mg 100 mg 25 mg 100 mg 100 mg 100 mg 50 mg 50 mg 100 mg 50 mg 25 mg
Lægemiddelform Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu) Blister (PVC/ PCTFE/ alu)
Packaging blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu)
Pakningsstørrelse 14 kapsler 56 kapsler 56 kapsler 56 kapsler 28 kapsler 28 kapsler 98 kapsler 196 kapsler 28 kapsler 14 kapsler 84 kapsler 84 kapsler 84 kapsler
Package size 14 capsules 56 capsules 56 capsules 56 capsules 28 capsules 28 capsules 98 capsules 196 capsules 28 capsules 14 capsules 84 capsules 84 capsules 84 capsules
Zonegran 25 mg kapsel, hård.
Zonegran 25 mg hard capsules.
Hver Zonegran- kapsel, hård indeholder 25 mg zonisamid.
Each Zonegran hard capsule contains 25 mg of zonisamide.
En hvid uigennemsigtig underdel og en hvid uigennemsigtig overdel hvorpå der er trykt logo og “ ZONEGRAN 25 ” i sort.
A white opaque body and a white opaque cap printed with a logo and “ ZONEGRAN 25” in black.
Zonegran er indiceret som supplerende behandling ved behandling af voksne patienter med partielle kramper med eller uden sekundær generalisering.
Zonegran is indicated as adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.
Zonegran- kapsel, hård er til oral anvendelse.
Zonegran hard capsules are for oral use.
Zonegran skal lægges til eksisterende behandling og dosis skal titreres på basis af klinisk virkning.
Zonegran must be added to existing therapy and the dose should be titrated on the basis of clinical effect.
Det er blevet vist, at doser på 300 til 500 mg i døgnet er effektive, om end nogle patienter især de, der ikke tager CYP3A4- inducerende stoffer, kan respondere på lavere doser.
Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Den anbefalede initiale døgndosis er 50 mg fordelt på to doser.
The recommended initial daily dose is 50 mg in two divided doses.
Efter en uge kan dosis øges til 100 mg daglig og derefter kan dosis øges med en uges interval med øgning på op til 100 mg.
After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at one weekly intervals, in increments of up to 100 mg.
4. 5).
Use of two weekly intervals should be considered for patients with renal or hepatic impairment and patients not receiving CYP3A4-inducing agents (see Section 4.5).
Zonegran kan indgives en eller to gange daglig efter titreringsfasen.
Zonegran can be administered once or twice daily after the titration phase.
Der skal udvises forsigtighed i starten af behandlingen hos ældre patienter, da der foreligger begrænset information om brugen af Zongran til disse patienter.
Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
4. 8)
Prescribers should also take account of the safety profile of Zonegran (see Section 4.8).
Sikkerheden og effekten hos børn og unge under 18 år er ikke fastslået.
The safety and effectiveness in children and adolescents under 18 years have not been established.
Brugen til disse patienter anbefales derfor ikke.
Therefore use in these patients is not recommended.
2 Patienter med nedsat nyrefunktion
2 Patients with renal impairment
Plasma- AUC for zonisamid blev øget med 35% hos patienter med creatininclearance < 20 ml/ min.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min.
5. 2)
Zonegran may be taken with or without food (see Section 5.2).
Seponering af Zonegran
Withdrawal of Zonegran
Når behandling med Zonegran skal seponeres, bør det ske gradvis.
When Zonegran treatment is to be discontinued, it should be withdrawn gradually.
I kliniske undersøgelser har dosisreduktioner på 100 mg med ugentlige intervaller været anvendt samtidig med dosisjustering af andre antiepileptika.
In clinical studies, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic drug doses.
Overfølsomhed over for zonisamid, over for et eller flere af hjælpestofferne eller over for sulfonamider.
Hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
Der forekommer alvorlige udslæt i forbindelse med Zonegranbehandling, herunder tilfælde af Stevens- Johnson- syndrom.
Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
I overensstemmelse med gængs klinisk praksis skal seponering af Zonegran hos patienter med epilepsi ske ved gradvis dosisreduktion for at reducere risikoen for kramper i forbindelse med seponering.
In accordance with current clinical practice, discontinuation of Zonegran in patients with epilepsy must be accomplished by gradual dose reduction, to reduce the possibility of seizures on withdrawal.
Der er utilstrækkelige data vedrørende seponering af ledsagende antiepileptika, straks der er opnået kontrol over kramperne med Zonegran i suppleringssituationen, for at nå frem til monoterapi med Zonegran.
There are insufficient data for the withdrawal of concomitant antiepileptic medications once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
Seponering af ledsagende antiepileptika skal derfor ske med forsigtighed.
Therefore withdrawal of concomitant anti-epileptic agents must be undertaken with caution.
Zonegran er et benzisoxazolderivat, som indeholder en sulfonamid gruppe.
Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Alvorlige immunbaserede bivirkninger, som har forbindelse med lægemidler indeholdende en sulfonamidgruppe, omfatter udslæt, allergisk reaktion og alvorlige hæmatologiske sygdomme inklusive aplastisk anæmi, der i meget sjældne tilfælde kan være fatalt.
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal.
3 Der er rapporteret tilfælde med agranulocytose, trombocytopeni, leukopeni, aplastisk anæmi, pancytopeni og leukocytose.
Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Nyresten har forekommet hos patienter behandlet med Zonegran.
3 Kidney stones have occurred in patients treated with Zonegran.
Zonegran skal anvendes med forsigtighed hos patienter, som har risikofaktorer for nephrolithiasis herunder tidligere stendannelse, familieanamnese med nephrolithiasis og hypercalcuri.
Zonegran should be used with caution in patients who have risk factors for nephrolithiasis, including prior stone formation, a family history of nephrolithiasis and hypercalcuria.
Disse patienter kan have en øget risiko for nyrestensdannelse og dermed forbundne tegn og symptomer så som nyrekolik, nyre - eller flankesmerter.
Such patients may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Derudover kan patienter, der tager andre lægemidler i forbindelse med nephrolithiasis have en øget risiko.
In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
4. 5).
Zonegran should be used with caution in patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate, as there are insufficient data to rule out a pharmacodynamic interaction (see Section 4.5).
Patienter eller dem, der tager sig af dem, skal gøres opmærksom på at opretholde væskebalancen og undgå udsættelse for meget høje temperaturer.
Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures.
Det omfatter kulsyreanhydrasehæmmere og lægemidler med antikolinerg virkning.
Caution should be used when Zonegran is prescribed with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Hos patienter, der tager Zonegran og som udvikler kliniske tegn og symptomer på pancreatitis, anbefales det at kontrollere pancreaslipase og amylase.
In patients taking Zonegran who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
Hos patienter, der tager Zonegran, hvor der udvikles alvorlige muskelsmerter/ eller svaghed enten med eller uden feber, anbefales det, at kontrollere markører for muskelskade herunder creatinfosfokinase og aldolase koncentrationen i serum.
In patients taking Zonegran, in whom severe muscle pain and/ or weakness develop either in the presence or absence of a fever, it is recommended that markers of muscle damage be assessed, including serum creatine phosphokinase and aldolase levels.
Hvis de er forhøjet uden anden årsag som f. eks. traume eller grand mal anfald, anbefales det at overveje at seponere Zonegran og påbegynde passende behandling.
If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that Zonegran discontinuation be considered and appropriate treatment initiated.
4. 6).
Women of child-bearing potential must use adequate contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
Læger, der behandler patienter med Zonegran skal prøve at sikre, at der bliver anvendt passende kontraception og bør anvende klinisk skøn ved vurderingen af, hvorvidt perorale kontraceptiva eller doseringen af bestanddelene i perorale kontraceptiva er passende, baseret på den enkelte patients kliniske situation.
Physicians treating patients with Zonegran should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether OCs, or the doses of the OC components, are adequate based on the individual patient’ s clinical situation.
Zonegran 100 mg kapsel, hård indeholder en gul farve, der kaldes sunset yellow FCF (E110), som kan være årsag til allergiske reaktioner.
Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), which may cause allergic reactions.
Der findes begrænsede data fra kliniske undersøgelser af patienter med en legemsvægt på mindre end 40 kg.
There is limited data from clinical studies in patients with a body weight of less than 40 kg.
Disse patienter skal derfor behandles med forsigtighed.
Therefore these patients should be treated with caution.
Hvis der opstå et betydeligt uønsket vægttab, bør seponering af Zonegran overvejes.
If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
Virkning af Zonegran på cytochrom P450 enzymer
Effect of Zonegran on cytochrome P450 enzymes
In vitro studier med anvendelse af humane levermikrosomer viser ingen eller lille (< 25%) hæmning af cytochrom P450 isozymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4 ved koncentrationer af zonisamid, der er omkring to gange eller større end klinisk relevante ubundne
In vitro studies using human liver microsomes show no or little (< 25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately two- fold or greater than clinically relevant unbound serum concentrations.
Det forventes derfor ikke, at Zonegran påvirker farmakokinetikken af andre lægemidler via cytochrom P450- mediere mekanismer, som det er vist for carbamazepin, phenytoin, ethinylestradiol og desipramin in vivo.
Therefore Zonegran is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Zonegrans mulighed for at indvirke på andre lægemidler
4 Potential for Zonegran to affect other medicinal products
Antiepileptika Hos epilepsipatienter resulterede ligevægtsdosering med Zonegran ikke i klinisk relevante farmakokinetiske virkninger på carbamazepin, lamotrigin, phenytoin natriumvalproat.
Anti-epileptic drugs In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Perorale kontraceptiva I kliniske undersøgelser af raske forsøgspersoner påvirkede ligevægtsdosering med Zonegran ikke serumkoncentrationen af ethinylestradiol eller norethisteron i et kombineret peroralt kontraceptivum.
Oral contraceptives In clinical studies in healthy subjects, steady-state dosing with Zonegran did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Kulsyreanhydrasehæmmere Der foreligger utilstrækkelige data til at udelukke mulige farmakodynamiske interaktioner med kulsyreanhydrasehæmmere som f. eks. topiramat.
Carbonic anhydrase inhibitors There are insufficient data to rule out possible pharmacodynamic interactions with carbonic anhydrase inhibitors such as topiramate.
P- gp- substrat Et in vitro- studie viser, at zonisamid er en svag hæmmer af P- gp (MDR1) med en IC50 på 267 µmol/ l, og zonisamid kan i teorien påvirke farmakokinetikken for lægemidler, der er P- gp- substrater.
P-gp substrate An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/ L and there is the theoretical potential for zonisamide to affect the pharmacokinetics of drugs which are P-gp substrates.
Det tilrådes at udvise forsigtighed, når zonisamid- behandling iværksættes eller standses, eller når zonisamid- dosis ændres hos patienter, som også får lægemidler, der er P- gp- substrater (fx digoxin, kinidin).
Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving drugs which are P-gp substrates (e. g. digoxin, quinidine).
I kliniske undersøgelser havde samtidig indgift af lamotrigin ingen åbenbar virkning på zonisamids farmakokinetik.
In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Samtidig indgift af disse lægemidler bør derfor undgås.
The combination of Zonegran with other medicinal products that may lead to urolithiasis may enhance the risk of developing kidney stones; therefore the concomitant administration of such medicinal products should be avoided.
Stoffer, der kan inducere eller hæmme disse enzymer, kan derfor påvirke zonisamids farmakokinetik:
Zonisamide is metabolised partly by CYP3A4 (reductive cleavage), and also by N-acetyl-transferases and conjugation with glucuronic acid; therefore, substances that can induce or inhibit these enzymes may affect the pharmacokinetics of zonisamide:
- Enzyminduktion:
- Enzyme Induction:
Ekspositionen for zonisamid er mindre hos epilepsipatienter, der får
Exposure to zonisamide is lower in epileptic patients receiving
Det er usandsynligt, at disse virkninger kan have klinisk betydning, når Zonegran føjes til en eksisterende behandling.
CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Ændringer i zonisamidkoncentrationen kan dog forekomme, hvis samtidig behandling med et CYP3A4- inducerende antiepileptikum eller andre lægemidler seponeres, får dosis justeret eller påbegyndes og justering af Zonegrandosis kan blive nødvendig.
These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Rifampicin er et potent CYP3A4- inducerende stof.
Rifampicin is a potent CYP3A4 inducer.
Hvis samtidig indgift er nødvendig, skal patienten kontrolleres tæt og Zonegrandosis og andre CYP3A4- substrater justeres efter behov.
If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
- CYP3A4 hæmning:
- CYP3A4 Inhibition:
Baseret på kliniske data synes kendte og ukendte uspecifikke CYP3A4 -
Based upon clinical data, known specific and non-specific CYP3A4
hæmmere ikke at have klinisk relevant virkning på zonisamids farmakokinetiske eksponeringsparametre.
inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Vedligeholdelsesdosering af enten ketoconazol (400 mg daglig) eller cimetidin (1200 mg daglig) havde ingen kliniske relevante virkninger på enkeltdosisfarmakokinetikken for zonisamid givet til raske forsøgspersoner.
Steady-state dosing of either ketoconazole (400 mg/ day) or cimetidine (1200 mg/ day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Ændring af Zonegrandosis skulle derfor ikke være nødvendig, når det gives samtidigt med kendte CYP3A4 - hæmmere.
Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Der bør gives specialistrådgivning til kvinder, der sandsynligvis kan blive gravide med henblik på vurderiing af den optimale behandling under graviditet.
Women of childbearing potential should be given specialist
Kvinder i den fødedygtige alder bør have rådgivning af en specialist med hensyn til mulige virkninger af Zonegran på fostret, og risikoen bør diskuteres med patienten i relation til fordelene, inden behandlingen påbegyndes.
5 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
Risikoen for medfødt defekt øges med en faktor 2 til 3 for børn af mødre, der er behandlet med et antiepileptikum.
The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medication.
Behandling med flere antiepileptika kan være forbundet med en højere risiko for kongenitte misdannelser end ved monoterapi.
Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy.
Kvinder i den fødedygtige alder skal anvende sikker antikonception under behandling med Zonegran og i en måned efter seponering.
Women of childbearing potential must use adequate contraception during treatment with Zonegran, and for one month after discontinuation.
Der foreligger ikke tilstrækkelige data om brugen af Zonegran hos gravide kvinder.
There are no adequate data from the use of Zonegran in pregnant women.
5. 3).
Studies in animals have shown reproductive toxicity (see Section 5.3).
Der bør ikke foretgages pludselig seponering af antiepileptisk behandling, da dette kan medføre gennembrudsanfald, som vil kunne få alvorlige følger for både moder og barn.
No sudden discontinuation of anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child.
Der bør træffes beslutning om, hvorvidt amningen skal ophøre eller man skal ophøre med/ afstå fra behandling med Zonegran.
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from Zonegran therapy.
På grund af lang retentionstid for zonisamid i organismen, bør amning ikke genoptages før en måned efter, at behandlingen med Zonegran er afsluttet.
Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed.
Nogle patienter kan opleve døsighed eller koncentrationsbesvær især tidligt i behandlingen eller efter en dosisøgning.
Some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase.
Patienterne skal rådes til at udvise forsigtighed i forbindelse med aktiviteter, der kræver stor årvågenhed f. eks. bilkørsel eller betjening af maskiner.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e. g., driving or operating machinery.
Zonegran er givet til 1. 200 patienter i kliniske undersøgelser, hvoraf mere end 400 fik Zonegran i mindst 1 år.
Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
4. 4).
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see Section 4.4).