natgillin/translations-raw huggingface dataset:
Some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase.
Nekateri bolniki lahko občutijo zaspanost ali težave s koncentracijo, predvsem v začetku zdravljenja ali po povečanju odmerka.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e. g., driving or operating machinery.
Bolnike je treba opozoriti, da morajo biti previdni med aktivnostmi, ki zahtevajo visoko stopnjo budnosti, npr. vožnja ali upravljanje s stroji.
Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
V kliničnih študijah je Zonegran jemalo več kot 1. 200 bolnikov, več kot 400 jih je Zonegran jemalo najmanj eno leto.
In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Poleg tega sta bili obširni pomarketinški študiji z zonisamidom na Japonskem od leta 1989 in v ZDA od leta 2000.
It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Treba se je zavedati, da je Zonegran benzisoksazolni derivat, ki vsebuje sulfonamidno skupino.
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).
Z zdravili, ki vsebujejo sulfonamidno skupino, so povezani resni neželeni učinki imunskega izvora, ki vključujejo izpuščaj, alergijske reakcije in večje hematološke motnje, vključno z aplastično anemijo, ki so zelo redko lahko usodni (glejte poglavje 4. 4).
The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Najpogostejše neželene reakcije v študijah nadzorovanega dodatnega zdravljenja so bile somnolenca, vrtoglavica in anoreksija.
Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Neželene reakcije, povezane z Zonegranom, ugotovljene v kliničnih študijah in pomarketinškem nadzoru, so navedene spodaj.
The frequencies are arranged according to the following scheme:
Pogostost je urejena po sledeči shemi:
very common common uncommon rare very rare
Zelo pogosti Pogosti Občasni Redki Zelo redki
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1,000 < 1/ 100 ≥ 1/ 10,000 < 1/ 1,000 < 1/ 10,000 including isolated reports
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1. 000 < 1/ 100 ≥ 1/ 10. 000 < 1/ 1. 000 < 1/ 10. 000 vključno s posameznimi primeri
System Organ Class (MedDRA terminology)
6 MedDRA podatkovna baza glede na organske sisteme Infekcijske in parazitske bolezni
Uncommon
Občasni Pljučnica Infekcija urinarnega trakta
Infections and infestation
Bolezni krvi in limfatičnega sistema Bolezni imunskega sistema
Pneumonia Urinary tract infection
Ekhimoza Hipersenzitivnost
6 System Organ Class (MedDRA terminology)
Presnovne in prehranske motnje
Very Common
Anoreksija
Common
Hipokaliemija
Uncommon
Metabolna acidoza
Very Rare
Psihiatrične
Blood and lymphatic system disorders
Vznemirjenost
Ecchymosis
Čustvena
Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Jeza
Immune system disorders
Halucinacije
Hypersensitivity
motnje
Metabolism and nutrition disorders
Razdražljivost
Anorexia
labilnost
Hypokalaemia
Agresija
Metabolic acidosis
Zmedenost Depresija
Psychiatric Disorders
Anksioznost Nespečnost Psihotične motnje
Agitation Irritability Confusional state Depression
Samomorilska nagnjenja Poskus samomora
Affect lability Anxiety Insomnia Psychotic disorder
Bolezni živčevja
Anger Aggression Suicidal ideation Suicide attempt
Bradifrenija
Hallucination
Konvulzije
Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Ataxia Dizziness Memory impairment Somnolence Diplopia
Vrtoglavica Poslabšanje spomina Somnolenca Diplopija
Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Motnje pozornosti Nistagmus Parestezije Motnje govora Tremor
Amnesia Coma Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome Status epilepticus Dyspnoea Pneumonia aspiration Respiratory disorder
Koma Epileptični napad grand mal Miastenijski sindrom Nevroleptični maligni sindrom Epileptični status Dispnea Aspiracijska pljučnica Motnje dihanja
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
Bolečina v trebuhu Konstipacija Diareja Dispepsija Navzea
Cholecystitis Cholelithiasis
Holecistitis
Hepatocellular damage
Hepatocelularna
Skin and subcutaneous tissue disorders
žolčnika in žolčevodov
Rash
Holelitiaza
Rhabdomyolysis
poškodba
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Bolezni kože in podkožja
Calculus urinary
Izpuščaj
Hydronephrosis Renal failure Urine abnormality
Anhidroza Multiformni eritem Pruritus Stevens- Johnsonov sindrom
7 System Organ Class (MedDRA terminology)
7 MedDRA podatkovna baza glede na organske sisteme Bolezni mišično - skeletnega sistema in vezivnega tkiva
Very Rare
Zelo redki Rabdomioliza
Investigations
Kamni v sečilih
Decreased bicarbonate
Preiskave
Weight decreased
Zmanjšanje
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Povišanje kreatinin -
Heat stroke
bikarbonat
In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Poleg tega so se pri bolnikih, ki so jemali Zonegran, pojavili posamezni primeri nenadne nepojasnjene smrti pri bolnikih z epilepsijo (SUDEP – “ Sudden Unexplained Death in Epilepsy Patients ”).
Additional information on special populations:
Dodatne informacije o posebnih populacijah:
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events:
Pregled postmarketinških podatkov je pokazal, da so bolniki, stari 65 let ali več, v primerjavi s splošno populacijo poročali o pogostejšem pojavljanju naslednjih dogodkov:
Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Stevens- Johnsonov sindrom (SJS) in z zdravili povzročen sindrom preobčutljivosti (DIHS – “ Drug Induced Hypersensitivity Syndrome ”).
In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt.
V nekaj primerih je bilo preveliko odmerjanje asimptomatsko, zlasti pri tistih, kjer se je takoj pojavilo bruhanje ali pa je bilo izvedeno izpiranje želodca.
A very high plasma concentration of 100.1 μ g/ ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Bolnik je postal komatozen, pojavila se je depresija dihanja, vendar se je po petih dneh brez posledic prebudil iz kome.
No specific antidotes for Zonegran overdose are available.
Za preveliko odmerjanje Zonegrana ni na voljo specifičnega antidota.
Zonisamide has a long elimination half-life so its effects may be persistent.
Zonasemid ima dolgo razpolovno dobo izločanja, zato njegovi učinki lahko vztrajajo.
Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Čeprav ni bila formalno preizkušena kot zdravljenje za preveliko odmerjanje, hemodializa zmanjša
Anti-epileptics, ATC code:
Antiepileptiki, oznaka ATC:
Efficacy has been demonstrated with Zonegran in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Učinkovitost Zonegrana je bila prikazana v štirih dvojno slepih s placebom kontroliranih študijah, ki so trajale do 24 tednov z odmerjanjem enkrat ali dvakrat na dan.
These studies show that the median
Te študije kažejo, da je srednje znižanje pogostosti parcialnih epileptičnih napadov povezano z odmerkom Zonegrana.
8 reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Trajna učinkovitost je dosežena pri odmerkih od 300 do 500 mg na dan.
The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
V teh modelih je zonisamid deloval kot antiepileptik širokega spektra.
The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
S tem zmanjšuje širjenje epileptičnega napada in zmanjša posledično epileptično aktivnost.
Absolute bioavailability is estimated to be approximately 100%.
Presnova prvega prehoda naj bi bila zanemarljiva, absolutna biorazpoložljivost je približno 100%.
Oral bioavailability is not affected by food, although peak plasma and serum concentrations may be delayed.
Na peroralno biorazpoložljivost hrana ne vpliva, čeprav so vrhovi plazemskih in serumskih koncentracij doseženi kasneje.
The increase at steady state was slightly more than expected on the basis of dose, probably due to the saturable binding of zonisamide to erythrocytes.
Povečanje v stanju dinamičnega ravnovesja je bilo nekoliko večje kot bi bilo pričakovati na osnovi odmerka, verjetno zaradi vezave zonisamida na eritrocite.
Zonisamide is 40 - 50% bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i. e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
In vitro študije so pokazale, da prisotnost drugih antiepileptičnih zdravil (kot npr. fenitoin, fenobarbiton, karbamazepin in natrijev valproat) ne vpliva na vezavo na proteine.
The apparent volume of distribution is about 1.1 – 1.7 l/ kg in adults indicating that zonisamide is extensively distributed to tissues.
Volumen porazdelitve pri odraslih je med 1, 1 - 1, 7 l/ kg, kar kaže na to, da se zonisamid močno porazdeljuje v tkiva.
Erythrocyte/ plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Razmerje eritrocit/ plazma je pri nižjih koncentracijah okoli 15 ter pri višjih okoli 3.
Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
9 Zonisamid se v osnovi presnavlja prek reduktivne cepitve obroča benzisoksazola izvornaga zdravila z CYO3A4, ki tvori 2- sulfamoilacetilfenol (SMAP – “ 2- sulphamoylacetylphenol ”), pa tudi z N - acetilacijo.
Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Navidezni očistek zonisamida v stanju dinamičnega ravnovesja po peroralnem dajanju je 0, 70 l/ h in končni razpolovni čas izločanja v odsotnosti induktorjev CYP3A4 približno 60 ur.
Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
Fluktuacije v serumski ali plazemski koncentraciji v intervalu odmerjanja so nizke (< 30%).
Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/ min); about 15 - 30% of the dose is eliminated unchanged.
Ledvični očistek nespremenjenega zonisamida je relativno nizek (približno 3, 5 ml/ min), približno 15 - 30% odmerka se iz telesa izloči nespremenjenega.
9 In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
Pri bolnikih z ledvično okvaro je ledvični očistek enkratnega odmerka zonisamida pozitivno koreliral z očistkom kreatinina.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min (see also section 4.2.).
Plazemska AUC zonisamida se je pri bolnikih z očistkom kreatinina < 20 ml/ min povečala za 35% (glejte poglavje 4. 2).
Patients with an impaired liver function:
Bolniki z jetrno okvaro:
The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Farmakokinetika zonisamida pri bolnikih z jetrno okvaro ni bila ustrezno preučena.
No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Med mladimi (starimi 21 – 40 let) in starejšimi (65 – 75 let) ni opaznih klinično pomembnih razlik v farmakokinetiki.
Adolescents (12-18 years):
Mladostniki (12 – 18 let):
Limited data indicate that pharmacokinetics in adolescents dosed to steady state at 1, 7 or 12 mg/ kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Omejeni podatki kažejo, da je farmakokinetika pri mladostnikih v stanju dinamičnega ravnovesja pri odmerkih 1, 7 ali 12 mg/ kg na dan v deljenih odmerkih podobna kot pri odraslih po prilagoditvi glede na telesno težo maso.
No clear Zonegran dose-concentration-response relationship has been defined.
Jasne povezava med odmerkom, koncentracijo in odgovorom pri Zonegranu ni bila opažena.
Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Starost (≥ 12 let) in spol po prilagoditvi učinkov zaradi telesne mase nimata očitnih učinkov na izpostavljenost zonisamidu pri epileptičnih bolnikih v stanju dinamičnega ravnovesja.
Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Ugotovitve do katerih so prišli pri psih, ki so bili izpostavljeni koncentracijam podobnim kot v klinični uporabi, ne pa tudi v kliničnih študijah so spremembe na jetrih (povečanje, temnorjavo obarvanje, rahlo povečanje hepatocitov s koncentričnimi lamelarnimi telesci v citoplazmi ter citoplazemska vakuolizacija), povezane s povečano presnovo.
Zonisamide was not genotoxic and has no carcinogenic potential.
Zonisamid ni genotoksičen in nima karcenogenega potenciala.
Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Zonisamid je povzročil razvojne nepravilnosti pri miših, podganah in psih, pri opicah je povzročil smrt zarodka, če je bil dan v času organogeneze v odmerkih in koncentracijah v materini plazmi, podobnimi ali nižjimi kot so terapevtski koncentracije pri ljudeh.
Microcrystalline cellulose Hydrogenated vegetable oil Sodium laurilsulfate.
Vsebina kapsule mikrokristalna celuloza hidrogenirano rastlinsko olje natrijev lavrilsulfat
Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
Telo kapsule: želatina titanijev dioksid (E171) šelak propilenglikol kalijev hidroksid črni železov oksid (E172)
10 6.3 Shelf life
6. 3 Rok uporabnosti
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56, and 84 hard capsules.
PVC/ PCTFE/ aluminijasti pretisni omot, škatla s 14, 28, 56 in 84 trdimi kapsulami.
Eisai Limited 3 Shortlands London W6 8EE United Kingdom
Eisai Limited 3 Shortlands London W6 8EE Velika Britanija
Zonegran 50 mg hard capsules.
Zonegran 50 mg trde kapsule
Each Zonegran hard capsule contains 50 mg of zonisamide.
Vsaka trda kapsula Zonegrana vsebuje 50 mg zonisamida.
A white opaque body and a grey opaque cap printed with a logo and “ ZONEGRAN 50” in black.
Bel, neprozoren spodnji del kapsule, z sivim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 50'' v črni barvi.
Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonegran might be required.
Bolniki z ledvično okvaro 13 Pri zdravljenju bolnikov z ledvično okvaro z Zonegranom je potrebna previdnost, saj so o zdravljenju teh bolnikov na voljo le omejeni podatki in je pri njih potrebno počasnejše prilagajanje odmerka.
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 rarley can be fatal.
Z zdravili, ki vsebujejo sulfonamidno skupino, so povezani resni neželeni učinki imunskega izvora, ki vključujejo izpuščaj, alergijske reakcije in večje hematološke motnje, vključno z aplastično anemijo, ki so zelo redko lahko usodni.
13 Kidney stones have occurred in patients treated with Zonegran.
14 Pri bolnikih, zdravljenih z Zonegranom, so se pojavili ledvični kamni.
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.
In vitro študije v katerih so uporabili humane jetrne mikrosome, niso pokazale ali pa so pokazale nizko (< 25%) inhibicijo izoencimov 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A4 citokroma P450, pri koncentracijah zonisamida, ki so bile dva ali večkrat višje od klinično pomembnih nevezanih 15 serumskih koncentracij.
14 Potential for Zonegran to affect other medicinal products
Možni učinki Zonegrana na druga zdravila
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy.
16 bolnicah, ki želijo zanositi, je treba ponovno preučiti.
15 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.
Ženske, za katere je verjetno, da bodo zanosile, potrebujejo nasvet specialista, da bodo lahko pretehtale najboljše možno zdravljenje v nosečnosti.
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.
Antiepileptičnega zdravljenja ne smemo nenadoma prekiniti, ker bi to lahko povzročilo prekinitvene epileptične napade, ki bi lahko imeli tako za mater kot za otroka resne posledice
16 System Organ Class (MedDRA terminology)
17 MedDRA podatkovna baza glede na organske sisteme Infekcijske in parazitske bolezni
Blood and lymphatic system disorders
Presnovne in prehranske motnje
Ecchymosis
Anoreksija
Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Hipokaliemija
Immune system disorders
Metabolna acidoza
Hypersensitivity
Psihiatrične
Metabolism and nutrition disorders
Vznemirjenost
Anorexia
Čustvena
Hypokalaemia
Halucinacije
Metabolic acidosis
Razdražljivost
Psychiatric Disorders
Zmedenost Depresija
Agitation Irritability Confusional state Depression
Anksioznost Nespečnost Psihotične motnje
Affect lability Anxiety Insomnia Psychotic disorder
Samomorilska nagnjenja Poskus samomora
Anger Aggression Suicidal ideation Suicide attempt
Bolezni živčevja
Hallucination
Bradifrenija
17 System Organ Class (MedDRA terminology)
18 MedDRA podatkovna baza glede na organske sisteme
Renal and urinary disorders General disorders and administration site conditions
Anhidroza Multiformni eritem Pruritus Stevens - Johnsonov sindrom Rabdomioliza
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Nefrolitiaza Utrujenost Gripi podobna bolezen Pireksija
Calculus urinary
Kamni v sečilih
Hydronephrosis Renal failure Urine abnormality
Hidronefroza Ledvična odpoved Nenormalnosti urina
Decreased bicarbonate
Znižan
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Povišanje
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events:
Pregled postmarketinških analiz je pokazal, da so bolniki, stari 65 let ali več, v primerjavi s splošno populacijo poročali o pogostejšem pojavljanju naslednjih dogodkov:
A very high plasma concentration of 100.1 μ g/ ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Pri bolniku, ki je zaužil prevelik odmerek Zonegrana in klonazepama, se je po približno 31 urah pojavila zelo visoka
18 Zonisamide is a benzisoxazole derivative.
Zonisamid je derivat benzisoksazola.
These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Trajna učinkovitost je dosežena pri odmerkih od 300 do 500 mg na dan.
Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
Zonisamid se v osnovi presnavlja prek reduktivne cepitve obroča benzisoksazola izvornaga zdravila z CYO3A4, ki tvori 2- sulfamoilacetilfenol (SMAP – “ 2- sulphamoylacetylphenol ”), pa tudi z N - acetilacijo.
19 Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Navidezni očistek zonisamida v stanju dinamičnega ravnovesja po peroralnem dajanju je 0, 70 l/ h in končni razpolovni čas izločanja v odsotnosti induktorjev CYP3A4 približno 60 ur.
Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
21 Zonisamid je povzročil razvojne nepravilnosti pri miših, podganah in psih, pri opicah je povzročil smrt zarodka, če je bil dan v času organogeneze v odmerkih in koncentracijah v materini plazmi, podobnimi ali nižjimi kot so terapevtski koncentracije pri ljudeh.
Gelatin Titanium dioxide (E171)
Telo kapsule: želatina titanijev dioksid (E171) šelak propilenglikol kalijev hidroksid črni železov oksid (E172)
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
PVC/ PCTFE/ aluminijasti pretisni omot, škatla s 14, 28, 56 in 84 trdimi kapsulami.
6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
EU/ 1/ 04/ 307/ 010 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 012
EU/ 1/ 04/ 307/ 010 22 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 012
Zonegran 100 mg hard capsules.
Zonegran 100 mg trde kapsule
Each Zonegran hard capsule contains 100 mg of zonisamide.
Vsaka trda kapsula Zonegrana vsebuje 100 mg zonisamida.
A white opaque body and a red opaque cap printed with a logo and “ ZONEGRAN 100” in black.
Bel, neprozoren spodnji del kapsule, z rdečim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 100'' v črni barvi.
22 Patients with renal impairment
24 Bolniki z ledvično okvaro
23 Kidney stones have occurred in patients treated with Zonegran.
25 Pri bolnikih, zdravljenih z Zonegranom, so se pojavili ledvični kamni.
Effect of Zonegran on cytochrome P450 enzyme
Učinek Zonegrana na encime citokrom P450