natgillin/translations-raw huggingface dataset:
Women planning a pregnancy should meet with their specialists to reassess treatment with zonisamide and to consider other therapeutic options. 
Ženske, ki načrtujejo zanositev, se morajo posvetovati z zdravnikom specialistom, da se ponovno oceni zdravljenje z zonisamidom in razmisli o drugih možnostih zdravljenja.
Adults - recommended dosage escalation and maintenance regimen 
Odrasli - priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka
Heat stroke and dehydration Preventing overheating and dehydration in children 
Vročinska kap in dehidracija Preprečevanje pregretja in dehidracije pri otrocih
Subjects were randomised to carbamazepine and zonisamide received treatment for a duration of up to 24 months depending on response. 
Osebe so bile randomizirane v skupini s karbamazepinom in zonisamidom in so zdravilo glede na odziv prejemale do 24 mesecev.
The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients. 
Zgoraj navedeni opozorila in previdnostni ukrepi veljajo tudi za mladostnike in pediatrične bolnike.
CYP3A4 inhibition: Based upon clinical data, known specific and non-specific CYP3A4 inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters. 
• zaviranje CYP3A4: Glede na klinične podatke znani specifični ali nespecifični zaviralci CYP3A4 nimajo klinično pomembnih učinkov na farmakokinetične parametre izpostavljenosti zonisamidu.
Zonisamide Mylan may be taken as monotherapy or added to existing therapy in adults. 
Zdravilo Zonisamid Mylan se lahko uporablja kot monoterapija ali se doda k obstoječi terapiji pri odraslih.
Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures and strenuous physical exercise depending on the condition of the patient. 
Bolnike ali njihove skrbnike je treba opozoriti na zadostno hidracijo in izogibanje izpostavljenosti visokim temperaturam in da ne izvajajo fizično napornih dejavnosti ob upoštevanju stanja bolnika.
In clinical studies of adult patients, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic medicine doses (where necessary). 
V kliničnih študijah pri odraslih so odmerek zdravila zmanjševali po 100 mg na teden s sočasno prilagoditvijo odmerka ostalih antiepileptičnih zdravil (kjer je bilo potrebno).
A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below 22 mmol/L. 
Skupaj 70,4 % pediatričnih bolnikov, ki so prejemali zonisamid v kontrolirani študiji ali odprtem podaljšku študije, je imelo zaradi zdravljenja vsaj eno izmerjeno vrednost bikarbonata pod 22 mmol/l.
Physicians treating patients with zonisamide should ensure that patients are fully informed about the need to use appropriate effective contraception and should use clinical judgement when assessing whether oral contraceptives (OCs), or the doses of the OC components, are adequate based on the individual patient's clinical situation. 
Zdravniki, ki za zdravljenje uporabljajo zonisamid, morajo zagotoviti, da so bolniki v celoti obveščeni o potrebi uporabe ustrezne učinkovite kontracepcije in s klinično presojo oceniti, ali so peroralni kontraceptivi ali odmerki učinkovin v peroralnih kontraceptivih ustrezni glede na klinično stanje posameznega bolnika.
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: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS). 
Pregled podatkov iz obdobja trženja kaže, da je pri bolnikih, starih več kot 65 let, večja pogostnost naslednjih neželenih učinkov kot pri splošni populaciji: Stevens-Johnsonov sindrom (SJS) in z zdravili povzročen sindrom preobčutljivosti (DIHS - ''Drug Induced Hypersensitivity syndrome'').
The most common side effects of Zonisamide Mylan are mild. 
Najpogostejši neželeni učinki zdravila Zonisamid Mylan so blagi.
If you take more Zonisamide Mylan than you should If you may have taken more Zonisamide Mylan than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you. 
Če ste vzeli večji odmerek zdravila Zonisamid Mylan, kot bi smeli Če ste vzeli večji odmerek zdravila Zonisamid Mylan, kot bi smeli, o tem takoj obvestite vašega skrbnika (sorodnika ali prijatelja), vašega zdravnika ali farmacevta, ali pa se zglasite na oddelku za nujno medicinsko pomoč najbližje bolnišnice in s seboj prinesite zdravilo.
In a zonisamide placebo-controlled study conducted in paediatric and adolescent patients, the proportion of patients with impaired cognition was numerically greater in the zonisamide group compared with the placebo group. 
V študiji zonisamida, kontrolirani s placebom, izvedeni pri pediatričnih bolnikih in mladostnikih, je bil delež bolnikov z okvarjenimi kognitivnimi funkcijami številčno večji v skupini z zonisamidom v primerjavi s skupino s placebom.
300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day. 
500 mg za otroka s telesno maso več kot 55 kg (kateri odmerek je manjši) enkrat na dan.
- The recommended dose is 300 mg once a day. 
• Priporočeni odmerek je 300 mg enkrat na dan.
Adjunctive therapy - with CYP3A4inducing agents (see section 4.5) 
Dodatno zdravljenje - z induktorji CYP3A4 (glejte poglavje 4.5)
In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving zonisamide. 
Poleg tega so se pri bolnikih, ki so jemali zonisamid, pojavili posamezni primeri nenadne nepojasnjene smrti pri bolnikih z epilepsijo (SUDEP - “Sudden Unexplained Death in Epilepsy Patients”).
Zonisamide Mylan with food and drink Zonisamide Mylan can be taken with or without food. 
Zdravilo Zonisamid Mylan skupaj s hrano in pijačo Zdravilo Zonisamid Mylan se lahko jemlje skupaj s hrano in pijačo ali brez njih.
Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or medicinal products) may be additive to the bicarbonate lowering effects of zonisamide. 
Stanja ali zdravljenja, ki bolnika izpostavljajo možnosti nastanka acidoze (na primer bolezen ledvic, hude bolezni dihal, epileptični status, driska, operacija, ketogena dieta ali zdravila), imajo lahko na zniževanje bikarbonata, ki je posledica zonisamida, aditiven učinek.
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, končni razpolovni čas izločanja v odsotnosti induktorjev CYP3A4 pa je približno 60 ur.
The warnings and precautions mentioned below are more relevant to paediatric and adolescent patients. 
Spodaj navedeni opozorila in previdnostni ukrepi so bolj pomembni za pediatrične bolnike in mladostnike.
Specific safety issues that were encountered in the paediatric studies were: decreased appetite and weight loss, decreased bicarbonate levels, increased risk of kidney stones and dehydration. 
Specifične težave glede varnosti, ki so jih opazili v študijah pri pediatrični populaciji, so bile: zmanjšanje apetita in izguba telesne mase, znižanje ravni bikarbonata, povečano tveganje za ledvične kamne in dehidracijo.
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 substances which are P-gp substrates. 
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 substanc, ki so substrati P-gp.
- The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or 
• Priporočeni dnevni odmerek je 6 do 8 mg na kg za otroka s telesno maso do 55 kg ali 300 do
Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition. 
Zonisamid ima tudi modulatorni učinek na z GABA posredovano nevronsko inhibicijo.
Symptoms may occur within hours to weeks of initiating therapy. 
Simptomi se lahko pojavijo v nekaj urah po začetku zdravljenja in do nekaj tednov zatem.
No specific antidotes for zonisamide overdose are available. 
Za preveliko odmerjanje zonisamida ni na voljo specifičnega antidota.
Studies in animals have shown changes in fertility parameters (see section 5.3). 
Študije na živalih so pokazale spremembe v parametrih plodnosti (glejte poglavje 5.3).
• monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1); 
• monoterapija za zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri bolnikih z na novo diagnosticirano epilepsijo (glejte poglavje 5.1);
In clinical studies of paediatric patients, down-titration was completed by dose reductions at weekly intervals in increments of about 2 mg/kg (i.e. in accordance with the schedule in Table 3). 
V kliničnih študijah s pediatričnimi bolniki so odmerek v tedenskih intervalih zmanjševali po približno 2 mg/kg (tj. v skladu z načrtom v preglednici 3).
In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of zonisamide should be considered. 
Če se pojavijo znaki ali simptomi dehidracije, oligohidroze ali zvišane telesne temperature, je treba razmisliti o prekinitvi zdravljenja z zonisamidom.
Dosage escalation and maintenance 
Stopnjevanje in vzdrževanje odmerka
The amounts by which bicarbonate is decreased are usually small - moderate (average decrease of approximately 3.5 mEq/l at daily doses of 300 mg in adults); rarely patients can experience more severe decreases. 
Znižanje bikarbonata je ponavadi majhno do zmerno (ob dnevnih odmerkih 300 mg pri odraslih je povprečno znižanje približno 3,5 mEq/l); pri bolnikih redko pride do večjega znižanja.
- Zonisamide Mylan capsules must be swallowed whole with water. 
- Kapsule zdravila Zonisamid Mylan morate pogoltniti cele z nekaj vode.
Heat stroke requiring hospital treatment was diagnosed in some cases. 
V nekaterih primerih je bila diagnosticirana vročinska kap, ki je zahtevala bolnišnično zdravljenje.
Recommended escalation and maintenance doses are given in Table 2. 
Priporočeni odmerki za stopnjevanje in vzdrževanje so navedeni v preglednici 2.
Prescribers should also take account of the safety profile of zonisamide (see section 4.8). 
Zdravnik, ki predpisuje zonisamid, mora upoštevati tudi njegov varnostni profil (glejte poglavje 4.8).
In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression. 
Pri drugih pa so se po prevelikem odmerjanju pojavili simptomi kot na primer somnolenca, navzea, gastritis, nistagmus, mioklonus, koma, bradikardija, zmanjšana ledvična funkcija, hipotenzija in depresija dihanja.
When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest. 
Ko primerjamo isti odmerek, imajo preiskovanci z višjo telesno maso nižje serumske koncentracije v stanju dinamičnega ravnovesja, vendar pa je ta učinek relativno skromen.
If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg. 
Če je potreben višji odmerek: povečujte ga v dvotedenskih intervalih po 100 mg do največ 500 mg.
Increased levels of hepatobiliary parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) and bilirubin have occurred in paediatric and adolescent patients, without any consistent pattern in the observations of values above the upper limit of normal. 
Pri pediatričnih bolnikih in mladostnikih so se zvišale ravni hepatobiliarnih parametrov, kot so alaninaminotransferaza (ALT), aspartat-aminotransferaza (AST), gama-glutamiltransferaza (GGT) in bilirubin, brez doslednega vzorca opažanja vrednosti nad zgornjo mejo normalne vrednosti.
Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily. 
Vrednosti AUC in Cmax za zonisamid se po enkratnem odmerku v intervalu od 100 - 800 mg in po večkratnem odmerku v intervalu od 100 do 400 mg enkrat na dan povečujeta skoraj linearno.
The recommended adult dose 
Priporočni odmerek za odrasle:
The frequencies are arranged according to the following scheme: 
Pogostost je opredeljena po sledeči shemi: zelo pogosti pogosti
- Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide Mylan, which may require an adjustment of your dose of Zonisamide Mylan. 
• Druga zdravila, na primer fenitoin, karbamazepin, fenobarbiton in rifampicin, lahko zmanjšajo koncentracijo zdravila Zonisamid Mylan v vaši krvi, zato bo mogoče treba prilagoditi odmerek zdravila Zonisamid Mylan, ki ga jemljete.
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 plazemsko koncentracijo zonisamida pri bolnikih z zmanjšanjo ledvično funkcijo, zato jo lahko uporabimo kot zdravljenje prevelikega odmerjanja, če je to klinično indicirano.
In patients taking zonisamide who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored. 
Pri bolnikih, zdravljenih z zonisamidom, pri katerih se pojavijo klinični znaki in simptomi pankreatitisa, je priporočljivo spremljanje ravni pankreatične lipaze in amilaze.
Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after zonisamide therapy is completed. 
Zaradi dolgega zadrževanja zonisamida v telesu se z dojenjem ne sme pričeti prej kot mesec dni po prenehanju zdravljenja z zonisamidom.
Among 465 subjects in the paediatric safety database (including a further 67 subjects from the extension phase of the controlled clinical trial) there were 7 deaths (1.5%; 14.6/1000 person-years): 2 cases of status epilepticus, of which one was related to severe weight loss (10% within 3 months) in an underweight subject and subsequent failure to take medication; 1 case of head injury/haematoma, and 4 deaths in subjects with pre-existing functional neurological deficits for various causes (2 cases of pneumonia-induced sepsis/organ failure, 1 SUDEP and 1 head injury). 
Med 465 bolniki v podatkovni bazi za varnost pri pediatrični populaciji (vključno s še 67 bolniki iz faze podaljšanega kontroliranega kliničnega preskušanja) je umrlo 7 bolnikov (1,5 %; 14,6/1.000 oseb-let): 2 primera epileptičnega statusa, od katerih je bil en povezan s hudo izgubo telesne mase (10 % v 3 mesecih) pri bolniku s prenizko telesno maso, ki ni jemal zdravil; 1 primer poškodbe glave/hematoma, 4 umrli bolniki pa so imeli obstoječe funkcijske nevrološke primanjkljaje zaradi različnih vzrokov (2 primera sepse zaradi pljučnice/odpovedi organov, 1 primer nenadne nepojasnjene smrti pri bolnikih z epilepsijo (SUDEP“Sudden Unexplained Death in Epilepsy Patients”) in 1 poškodba glave).
Most adverse effects observed in the juvenile rats were similar to those seen in the repeated-dose toxicity studies of zonisamide in adult rats, but renal tubular hyaline droplets and transitional hyperplasia were observed in the juvenile study only. 
Večina neželenih učinkov, ki so jih opazili pri podganjih mladičih, je bila podobna tistim, ki so jih opazili v študijah toksičnosti pri ponavljajočih odmerkih zonisamida pri odraslih podganah, vendar so renalne tubularne hialinske kapljice in tranzicijsko hiperplazijo opazili le v študiji pri mladičih.
Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing. 
Zonisamid se po peroralnem dajanju skoraj popolnoma absorbira in doseže vrh serumskih ali plazemskih koncentracij po dveh do petih urah.
Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above) In paediatric patients (aged 6 years and above), efficacy has been demonstrated with zonisamide in a double-blind, placebo-controlled study, which included 207 subjects and had a treatment duration of up to 24 weeks. 
Dodatno zdravljenje pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje, pri mladostnikih in pediatričnih bolnikih (starih 6 let in več) Pri pediatričnih bolnikih (starih 6 let in več) so učinkovitost dokazali v dvojno slepi, s placebom kontrolirani študiji z zonisamidom, v katero je bilo vključenih 207 bolnikov, ki se je zdravilo do 24 tednov.
- Zonisamide Mylan should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide. 
• Zdravilo Zonisamid Mylan morate pri odraslih previdno uporabljati, kadar ga jemljete skupaj z zdravili, ki lahko povzročajo ledvične kamne, na primer s topiramatom ali acetazolamidom.
Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, France 
Mylan S.A.S 117 allee des Parcs, 69800 Saint Priest, Francija
Following a suspected recent overdose, emptying the stomach by gastric lavage or by induction of emesis may be indicated with the usual precautions to protect the airway. 
Po sumu na nedavno preveliko odmerjanje je indicirano izpiranje želodca ali induciranje bruhanja ob običajni zaščiti dihalne poti.
Recommended escalation and maintenance doses are given in Table 1. 
Priporočeni stopnjevani in vzdrževalni odmerki so navedeni v preglednici 1.
- Do not take a double dose to make up for a forgotten dose. 
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in patients taking zonisamide who have underlying conditions which might increase the risk of acidosis, in patients who are at an increased risk of adverse consequences of metabolic acidosis and in patients with symptoms suggestive of metabolic acidosis. 
Ustrezno določanje in spremljanje koncentracij serumskega bikarbonata je potrebno pri bolnikih, ki jemljejo zonisamid in imajo osnovne bolezni, ki bi lahko zvečale tveganje acidoze, pri bolnikih z zvečanim tveganjem neželenih posledic metabolne acidoze in pri bolnikih s simptomi, ki kažejo na metabolno acidozo.
If zonisamide is prescribed during pregnancy, patients should be fully informed of the potential harm to the foetus and use of the minimal effective dose is advised along with careful monitoring. 
Če se zonisamid predpiše v nosečnosti, je treba bolnico obvestiti o vseh možnih tveganjih za plod; svetujeta se uporaba najmanjšega še učinkovitega odmerka in skrbno spremljanje.
This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase. 
Metabolna acidoza je posledica izgube bikarbonata preko ledvic zaradi inhibitornega učinka zonisamida na karboanhidrazo.
The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems. 
Zdravnik vam bo odmerek mogoče zvečeval počasneje, če se bodo pojavili neželeni učinki, če ste starejši ali če imate težave z ledvicami ali jetri.
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 serumskih koncentracij nevezane učinkovine.
Therefore children aged 6 years and above and with a body weight less than 20 kg should be treated with caution. 
Zato je treba otroke, stare 6 let in več, s telesno maso manj kot 20 kg, zdraviti previdno.
Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg: - The starting dose is 1 mg per kg of body weight taken once a day. 
Uporaba pri otrocih (starih 6 do 11 let) in mladostnikih (starih 12 do 17 let) s telesno maso vsaj 20 kg:
Zonisamide Mylan is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg. 
Zdravilo Zonisamid Mylan ni priporočljivo za otroke, ki imajo prenizko telesno maso ali imajo slab apetit, pri tistih, ki tehtajo manj kot 20 kg, pa ga je treba uporabljati previdno.
The adverse event profile of zonisamide in paediatric patients aged 6 to 17 years in placebo-controlled clinical studies was consistent with that of adults. 
Profil neželenih učinkov zonisamida pri pediatričnih bolnikih, starih 6 do 17 let, v kliničnih študijah, kontroliranih s placebom, je bil enak kot pri odraslih.
Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800 
Mylan Healthcare GmbH Tel: + 49 800 0700 800
Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome. 
V povezavi z zdravljenjem z zonisamidom se pojavljajo resni izpuščaji, vključno s primeri Stevens-Johnsonovega sindroma.
Zonisamide Mylan is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation). 
Zdravilo Zonisamid Mylan se uporablja za zdravljenje epileptičnih napadov, ki prizadenejo del možganov (parcialni napadi), tem pa lahko sledi napad, ki prizadene vse možgane (sekundarna generalizacija), lahko pa tudi ne.
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.
If your child's skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid: - take your child to a cool, shaded place - sponge your child's skin with cool (not cold) water - give your child cold water to drink - seek urgent medical assistance. 
Če postane koža vašega otroka na otip zelo vroča in je znojenja zelo malo ali ga ni, otrok postane zmeden, ima mišične krče ali postaneta srčni utrip ali dihanje hitrejša: - otroka spravite na hladno in v senco, - otrokovo kožo hladite s hladno (ne mrzlo) vodo, - otroku dajte piti mrzlo vodo, - poiščite nujno zdravniško pomoč.
117 Allee des Parcs, 69 800 Saint Priest, France 
117 Allee des Parcs, 69 800 Saint Priest, Francija
There is no need for dose adjustment with any of the AEDs including CYP3A4 inducers. 
Potrebe za prilagoditev odmerka ni pri nobenih AEZ, vključno z induktorji CYP3A4.
Note: a. To ensure a therapeutic dose is maintained the weight of a child should be monitored and the dose reviewed as weight changes occur up to a weight of 55 kg. 
Za zagotovitev vzdrževanja terapevskega odmerka je treba nadzirati telesno maso otroka in ob spremembah telesne mase do 55 kg prilagoditi odmerek.
The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect. 
Najpogosteje poročajo o zajčji ustnici, kardiovaskularnih malformacijah in okvarah nevralne cevi.