natgillin/translations-raw huggingface dataset:
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
Farmacevtska oblika Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula Trda kapsula
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)
Način uporabe zdravila Ovojnina Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu) Peroralno Pretisni omot (PVC/ PCTFE/ Alu)
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
Velikost pakiranja 14 kapsul 56 kapsul 56 kapsul 56 kapsul 28 kapsul 28 kapsul 98 kapsul 196 kapsul 28 kapsul 14 kapsul 84 kapsul 84 kapsul 84 kapsul
Zonegran 25 mg hard capsules.
Zonegran 25 mg trde kapsule
Each Zonegran hard capsule contains 25 mg of zonisamide.
Vsaka trda kapsula Zonegrana vsebuje 25 mg zonisamida.
A white opaque body and a white opaque cap printed with a logo and “ ZONEGRAN 25” in black.
Bel, neprozoren spodnji del kapsule, z belim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 25'' v črni barvi.
Zonegran is indicated as adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.
Zonegran je indiciran kot dodatna terapija pri zdravljenju odraslih bolnikov s parcialnimi epileptičnimi napadi z ali brez sekundarne generalizacije.
Zonegran must be added to existing therapy and the dose should be titrated on the basis of clinical effect.
Zonegran se mora dodati že obstoječi terapiji, odmerek pa se prilagaja na osnovi kliničnih učinkov.
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.
Nekateri bolniki pa se odzivajo tudi na nižje odmerke, predvsem tisti, ki ne prejemajo induktorjev CYP3A4.
The recommended initial daily dose is 50 mg in two divided doses.
Priporočen začetni dnevni odmerek je 50 mg na dan, razdeljen v dva odmerka.
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.
Po enem tednu odmerek lahko povišamo na 100 mg na dan, zatem pa lahko odmerek povišujemo v tedenskih intervalih do po 100 mg.
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).
Pri bolnikih z ledvično ali jetrno okvaro in bolnikih, ki ne prejemajo induktorjev CYP3A4, je treba razmisliti o dvotedenskih intervalih (glejte poglavje 4. 5).
Zonegran can be administered once or twice daily after the titration phase.
Po prilagoditvi odmerka se lahko Zonegran jemlje v enem ali dveh dnevnih odmerkih.
Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
Pri starejših bolnikih je na začetku zdravljenja potrebna previdnost, saj so podatki o zdravljenju teh bolnikov z Zonegramom omejeni.
Prescribers should also take account of the safety profile of Zonegran (see Section 4.8).
Zdravnik, ki predpisuje Zonegran, mora upoštevati tudi varnostni profil zdravila (glejte poglavje 4. 8).
The safety and effectiveness in children and adolescents under 18 years have not been established.
Varnost in učinkovitost pri otrocih in mladostnikih mlajših od 18 let ni bila ugotovljena.
Therefore use in these patients is not recommended.
Zato uporabe Zonegrana pri teh bolnikih ne priporočamo.
2 Patients with renal impairment
2 Bolniki z ledvično okvaro
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.
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.
Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
Ker se zonasemid in presnovki izločajo preko ledvic, je treba pri bolnikih, pri katerih se razvije akutna ledvična odpoved ali pa se pojavi klinično pomemben vztrajen porast serumskega kreatinina, zdravljenje z Zonegranom takoj prekiniti.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min.
Plazemska AUC zonisamida se pri bolnikih z očistkom kreatinina < 20 ml/ min poveča za 35%.
Therefore use in patients with severe hepatic impairment is not recommended.
Uporaba zdravila pri bolnikih z jetrno okvaro ni bila preizkušena, zato uporabe pri bolnikih s hudo jetrno okvaro ne priporočamo.
Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran may be required.
Pri zdravljenju bolnikov z blažjo do zmerno jetrno okvaro je potrebna previdnost in počasnejše prilagajanje odmerka Zonegrana.
Zonegran may be taken with or without food (see Section 5.2).
Zonegran se lahko jemlje s hrano ali brez nje (glejte poglavje 5. 2).
Withdrawal of Zonegran
Odtegnitev Zonegrana
When Zonegran treatment is to be discontinued, it should be withdrawn gradually.
Prenehanje zdravljenja z Zonegranom mora biti postopno.
In clinical studies, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic drug doses.
V kliničnih študijah so odmerek Zonegrana zmanjševali po 100 mg na teden s sočasno prilagoditvijo odmerka ostalih antiepileptičnih zdravil.
Hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
Preobčutljivost za zonisamid ali katerokoli pomožno snov ali sulfonamide.
Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
V povezavi z zdravljenjem z Zonegranom se pojavljajo resni izpuščaji, vključno s primeri Stevens- Johnsonovega sindroma.
Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash.
Pri bolnikih, pri katerih se razvije izpuščaj, ki ga ni mogoče razložiti na noben drug način, je treba pretehtati možnost ukinitve Zonegrana.
All patients who develop a rash while taking Zonegran must be closely supervised, with additional levels of caution applied to those patients receiving concomitant antiepileptic agents that may independently induce skin rashes.
Vse bolnike, pri katerih se med jemanjem Zonegrana pojavi izpuščaj, je treba skrbno nadzirati, še posebej pa je treba biti pozoren pri tistih bolnikih, ki sočasno prejemajo antiepileptična zdravila, ki lahko že sama po sebi povzročajo kožne izpuščaje.
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.
V skladu s trenutno klinično prakso je treba Zonegran ukiniti s postopnim zmanjšanjem odmerka zaradi zmanjšanja možnosti pojavljanja epileptičnih napadov ob odtegnitvi.
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.
Za morebitno monoterapijo z Zonegramom in ukinitvijo drugih antiepileptičnih zdravil po tem, ko dosežemo nadzor nad napadi, ni dovolj podatkov.
Therefore withdrawal of concomitant anti-epileptic agents must be undertaken with caution.
Zato je potrebna previdnost pri odtegnitvi drugih antiepileptikov.
Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Zonegran je 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.
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.
3 Kidney stones have occurred in patients treated with Zonegran.
3 Pri bolnikih, zdravljenih z Zonegranom, so se pojavili ledvični kamni.
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.
Pri zdravljenju bolnikov, ki imajo rizične dejavnike za nefrolitiazo, vključno s pojavom ledvičnih kamnov pred zdravljenjem, družinsko anamnezo nefrolitiaze ali hiperkalciurie, je potrebna previdnost.
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.
Pri teh bolnikih obstaja povečana nevarnost za pojav ledvičnih kamnov in z njimi povezanih znakov in simptomov kot na primer renalne kolike, renalne bolečine ali bolečine v ledjih.
In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Povečano nevarnost za nastanek ledvičnih kamnov imajo tudi bolniki, ki jemljejo druga zdravila povezana z nefrolitiazo.
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).
Previdnost pri uporabi Zonegrana je potrebna pri bolnikih, ki sočasno jemljejo inhibitorje karboanhidraze, kot na primer topiramat, ker je na voljo premalo podatkov, da bi lahko izključili farmakodinamične interakcije (glejte poglavje 4. 5).
Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Pri pediatričnih bolnikih so se pojavili primeri zmanjšanega potenja in povišane telesne temperature.
Most reports occurred during periods of warm weather.
Večina teh primerov se je pojavila v obdobjih toplega vremena.
Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures.
Bolnike ali njihove skrbnike je potrebno opozoriti na zadostno hidracijo in izogibanje izpostavljanju visokim temperaturam.
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.
Med te spadajo inhibitorji karboanhidraze in zdravila z antiholinergično aktivnostjo.
In patients taking Zonegran who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
Pri bolnikih, zdravljenih z Zonegranom, pri katerih se pojavijo klinični znaki in simptomi pankreatitisa, je priporočljivo spremljanje ravni pankreatične lipaze in amilaze.
If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of Zonegran be considered and appropriate treatment initiated.
Ob očitnem pankreatitisu in ob odsotnosti drugih očitnih razlogov je treba razmisliti o prenehanju zdravljenja z Zonegranom in začetkom ustreznega zdravljenja pankreatitisa.
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.
Pri bolnikih, zdravljenih z Zonegranom, pri katerih se pojavi huda mišična bolečina in/ ali oslabelost v prisotnosti povišane telesne temperature ali brez nje, je priporočljivo merjenje ravni označevalcev mišične okvare, vključno z ravnmi kreatin- fosfokinaze in aldolaze.
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.
Če sta povišani in ob odsotnosti drugih očitnih razlogov kot na primer travma ali epileptični napad grand mal, je treba razmisliti o prenehanju označevalcev epileptičnih napadov zdravljenja z Zonegranom in začetkom ustreznega zdravljenja.
Women of child-bearing potential must use adequate contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
Ženske v rodni dobi morajo med ter vsaj še mesec dni po končanem zdravljenju z Zonegranom uporabljati ustrezno kontracepcijo (glejte poglavje 4. 6).
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.
Zdravniki, ki zdravijo bolnike z Zonegranom, bi morali poskrbeti, da ti med zdravljenjem uporabljajo ustrezno kontracepcijo in bi morali uporabiti klinično presojo pri oceni ali so peroralni kontraceptivi (OC – “ oral contraceptive ”) ali odmerki komponent OC ustreznih glede na bolnikovo klinično situacijo.
Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), which may cause allergic reactions.
Zonegran 100 mg trde kapsule vsebujejo rumeno barvilo, imenovano oranžno FCF (E110), ki lahko povzroči alergijske reakcije.
Therefore these patients should be treated with caution.
O zdravljenju bolnikov s telesno maso manjšo kot 40 kg so na voljo le omejeni podatki, zato je pri zdravljenju teh bolnikov potrebna previdnost.
Zonegran may cause weight loss.
Zonegran lahko povzroči izgubo telesne mase.
A dietary supplement or increased food intake may be considered if the patient is losing weight or is underweight whilst on this medication.
V primeru, da bolnik med zdravljenjem z Zonegranom izgublja telesno maso ali pa ima prenizko telesno maso, je treba razmisliti o prehranskih dopolnilih ali povečanem vnosu hrane.
If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
V primeru znatne neželene izgube telesne mase je treba razmisliti o prekinitvi zdravljenja z Zonegranom.
Effect of Zonegran on cytochrome P450 enzymes
Učinek Zonegrana na encime citokrom P450
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 4 serumskih koncentracij.
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.
Zato ni pričakovati, da bi Zonegran preko mehanizmov, povezanih s citokromom P450, vplival na farmakokinetiko drugih zdravil, kot je bilo in vivo pokazano za karbamazepin, fenitoin, etinilestradiol in desipramin.
4 Potential for Zonegran to affect other medicinal products
Možni učinki Zonegrana na druga zdravila
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.
Antiepileptična zdravila Pri bolnikih z epilepsijo odmerjanje Zonegrana v stanju dinamičnega ravnovesja ni imelo klinično pomembnih farmakokinetičnih učinkov na karbamazepin, lamotrigin, fenitoin ali natrijev valproat.
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.
Peroralni kontraceptivi V kliničnih študijah pri zdravih preiskovancih odmerjanje Zonegrana v stanju dinamičnega ravnovesja ni imelo vpliva na serumske koncentracije etinilestradiola ali noretisterona v kombiniranem peroralnem kontraceptivu.
Carbonic anhydrase inhibitors There are insufficient data to rule out possible pharmacodynamic interactions with carbonic anhydrase inhibitors such as topiramate.
Inhibitorji karboanhidraze Da bi izključili možne farmakodinamične interakcije z inhibitorji karboanhidraze, kot na primer topiramat, ni na voljo zadostnih podatkov.
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.
Substrat P- gp Študija in vitro je pokazala, da je zonisamid šibak inhibitor P- gp (MDR1) z IC50 267 µmol/ l in da obstaja teoretična možnost, da bi zonisamid vplival na farmakokinetiko zdravil, ki so substrati P- gp.
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).
Pri bolnikih, ki prejemajo tudi zdravila, ki so substrati P- gp (npr. digoksin, kinidin), je pri uvajanju ali ukinjanju zdravljenja z zonisamidom ali spreminjanju odmerka zonisamida potrebna previdnost.
Potential medicinal product interactions affecting Zonegran
Možni učinki zdravil na Zonegran
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.
Zato se je treba sočasnemu jemanju teh zdravil izogibati.
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:
Zato lahko substance, ki inducirajo ali inhibirajo te encime, vplivajo na farmakokinetiko zonisamida:
Exposure to zonisamide is lower in epileptic patients receiving
• encimska indukcija: izpostavljenost zonisamidu pri epileptičnih bolnikih, ki so zdravljeni z zdravili, ki inducirajo CYP3A4, kot na primer fenitoin, karbamazepin in fenobarbiton je nižja.
CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
V primeru, ko je Zonegran dodan obstoječi terapiji, ti učinki niso klinično pomembni.
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.
Vendar pa se lahko pojavijo spremembe v koncentraciji zonisamida v primeru ukinitve, prilagajanja ali novega uvajanja antiepileptičnih ali drugih zdravil, ki inducirajo CYP3A4, zato bo morda potrebna prilagoditev odmerka Zonegrana.
If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
V primeru, da je sočasno jemanje zdravil nujno potrebno, je treba bolnika skrbno spremljati in odmerek Zonegrana ali ostalih CYP3A4 substratov primerno prilagoditi.
- CYP3A4 Inhibition:
• CYP3A4 inhibicija:
inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Glede na klinične podatke znani specifični ali nespecifični inhibitorji CYP3A4 nimajo klinično pomembnih učinkov na farmakokinetične parametre izpostavljenosti zonisamidu.
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.
Odmerjanje v stanju dinamičnega ravnovesja tako ketokonazola (400 mg/ dan) kot cimetidina (1200 mg/ dan) nista imela klinično pomembnih učinkov na farmakokinetiko enkratnega odmerka zonisamida pri zdravih preiskovancih.
Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Zato prilagajanje odmerka zonisamida pri sočasnem zdravljenju z znanimi inhibitorji CYP3A4 ni potrebno.
Zonegran must not be used during pregnancy unless clearly necessary, in the opinion of the physician, and only if the potential benefit is considered to justify the risk to the foetus.
Zonegrana ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
The need for anti- epileptic treatment should be reviewed in patients planning to become pregnant.
Uporablja se ga lahko le v primeru, ko možna korist opravičuje tveganje za plod.
If Zonegran is prescribed, careful monitoring is recommended.
Potrebo po antiepileptičnem zdravljenju pri
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy.
5 bolnicah, ki želijo zanositi, je treba ponovno preučiti.
Women of childbearing potential should be given specialist
V primeru, da zdravnik predpiše Zonegran, je potrebno skrbno spremljanje nosečnice.
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.
Ženske, za katere je verjetno, da bodo zanosile, potrebujejo nasvet specialista, da bodo lahko pretehtale najboljše možno zdravljenje v nosečnosti.
The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medication.
Pri otrocih mater, zdravljenih z antiepileptičnim zdravilom, se tveganje prirojene okvare zveča za dvakrat do trikrat.
Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy.
Antiepileptično zdravljenje z več zdravili je lahko povezano z večjim tveganjem prirojenih okvar kot monoterapija.
Women of childbearing potential must use adequate contraception during treatment with Zonegran, and for one month after discontinuation.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še štiri tedne po njem.
There are no adequate data from the use of Zonegran in pregnant women.
Ni zadostnih podatkov o uporabi Zonegrana pri nosečnicah.
Studies in animals have shown reproductive toxicity (see Section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from Zonegran therapy.
Treba se je odločiti ali prekiniti z dojenjem ali prenehati zdravljenje oziroma se trenutno vzdržati zdravljenja z Zonegranom.
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.
Zaradi dolgega zadrževanja zonisamida v telesu se z dojenjem ne sme pričeti prej kot mesec dni po prenehanju zdravljenja z Zonegranom.