FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment Regimen
Slovenian: Režim zdravljenja
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Slovenian: Farmakoterapevtska skupina: Antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX15
English: • The child should stay cool especially in hot weather
Slovenian: • mora ostati hladen, zlasti ob vročem vremenu;
English: • Take the child to a cool, shaded place
Slovenian: • otroka spravite na hladno in v senco,
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike nadzirati glede znakov samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
English: Effect of food Zonisamide Mylan may be taken with or without food (see section 5.2).
Slovenian: Učinki hrane Zdravilo Zonisamid Mylan se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulfonamides.
Slovenian: Preobčutljivost na učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, ali na sulfonamide.
English: Erythrocyte/plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Slovenian: Razmerje eritrocit/plazma je pri nižjih koncentracijah okoli 15 ter pri višjih okoli 3.
English: Zonisamide has a long elimination half-life so its effects may be persistent.
Slovenian: Zonisamid ima dolgo razpolovno dobo izločanja, zato njegovi učinki lahko vztrajajo.
English: • The child must drink plenty of cold water
Slovenian: • mora piti veliko hladne vode,
English: The incidence of a decrease in body weight of 10% or more was 10.7% (see section 4.4).
Slovenian: Pogostnost zmanjšanja telesne mase za 10 % ali več je bila 10,7 % (glejte poglavje 4.4).
English: Linearity / non-linearity
Slovenian: Linearnost/nelinearnost
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Slovenian: Simptomi vključujejo akutno zmanjšanje ostrine vida in/ali bolečine v očeh.
English: A pooled analysis of safety data on 95 elderly subjects has shown a relatively higher reporting frequency of oedema peripheral and pruritus compared to the adult population.
Slovenian: Analiza združenih podatkov o varnosti pri 95 starejših osebah je pokazala relativno visoko pogostnost perifernega edema in pruritusa v primerjavi z odraslo populacijo.
English: • Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines).
Slovenian: • Zvišana raven kisline v krvi in ledvični kamni: Ta tveganja zmanjšajte tako, da zagotovite, da otrok pije dovolj vode in da ne jemlje drugih zdravil, ki bi lahko povzročili ledvične kamne
English: - are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Slovenian: • če ste noseči ali lahko zanosite (za več informacij glejte poglavje "Nosečnost, dojenje in plodnost").
English: Date of first authorisation: 31 March 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 31. 03. 2016
English: The metabolites, which could not be detected in plasma, are devoid of anticonvulsant activity.
Slovenian: Presnovki, ki jih ni možno zaslediti v plazmi, nimajo antikonvulzivne aktivnost.
English: However, given that some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase, patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machines.
Slovenian: Ker pa nekateri bolniki lahko občutijo zaspanost ali težave s koncentracijo, predvsem v začetku zdravljenja ali po povečanju odmerka, je treba bolnike opozoriti, da morajo biti previdni med aktivnostmi, ki zahtevajo visoko stopnjo zbranosti, npr. vožnja ali upravljanje s stroji.
English: MonotherapyNewly diagnosed adult patients
Slovenian: MonoterapijaNa novo diagnosticirani odrasli bolniki
English: There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Slovenian: Za oceno morebitne povezave med odmerkom in trajanjem zdravljenja ter temi dogodki ni dovolj podatkov.
English: Preventing overheating and dehydration in children
Slovenian: Preprečevanje pregretja in dehidracije pri otrocih
English: Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
Slovenian: Fluktuacije v serumski ali plazemski koncentraciji v intervalu odmerjanja so nizke (< 30 %).
English: As with all antiepileptic medicines, sudden discontinuation of zonisamide should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Slovenian: Kot pri vseh drugih antiepileptikih se je treba nenadni prekinitvi uporabe zonisamida izogniti, saj lahko to povzroči izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
English: Weight loss leading to deterioration of general condition and failure to take anti-epilepsy medication has been related to a fatal outcome (see section 4.8).
Slovenian: Izguba telesne mase, ki povzroči poslabšanje splošnega stanja, in nejemanje zdravil proti epilepsiji sta bila povezana s smrtnim izidom (glejte poglavje 4.8).
English: Treatment includes discontinuation of zonisamide, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.
Slovenian: Zdravljenje vključuje ukinitev zonisamida, kolikor hitro je to mogoče po presoji lečečega zdravnika, in ustrezne ukrepe za znižanje znotrajočesnega tlaka.
English: The incidence of markedly abnormally low serum bicarbonate (a decrease to less than 17 mEq/l and by more than 5 mEq/l) was 3.8%.
Slovenian: Incidenca znatno neobičajno nizkega serumskega bikarbonata (znižanje na manj kot 17 mEq/l in za več kot 5 mEq/l) je bila 3,8 %.
English: Rifampicin is a potent CYP3A4 inducer.
Slovenian: Rifampicin je močan induktor CYP3A4.
English: - are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems.
Slovenian: • če ste mlajši kot 12 let, saj je pri vas morda večje tveganje za zmanjšano znojenje, vročinsko kap, pljučnico in težave z jetri.
English: A study showed that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy.
Slovenian: Študija je pokazala, da so otroci mater, ki so med nosečnostjo uporabljale zonisamid, manjši kot je pričakovano za njihovo starost ob rojstvu, v primerjavi z otroci mater, ki so se med nosečnostjo zdravile z monoterapijo z lamotriginom.
English: Paediatric population (aged 6 years and above)
Slovenian: Pediatrična populacija (starost 6 let in več)
English: Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received zonisamide for at least 1 year.
Slovenian: V kliničnih študijah je zonisamid jemalo več kot 1.200 bolnikov, več kot 400 jih je zonisamid jemalo najmanj eno leto.
English: Generally, zonisamide-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.
Slovenian: Ponavadi se metabolna acidoza, ki jo sproži zonisamid, pojavi zgodaj v poteku zdravljenja, primeri pa se lahko pojavijo kadarkoli med zdravljenjem.
English: The incidence of marked decreases in weight of 20% or more was 0.7%.
Slovenian: Incidenca znatnega zmanjšanja telesne mase za 20 % ali več je bila 0,7 %.
English: 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.
Slovenian: Povečanje v stanju dinamičnega ravnovesja je bilo nekoliko večje, kot bi bilo pričakovati na osnovi odmerka, verjetno zaradi nasičene vezave zonisamida na eritrocite.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnega razmišljanja ali vedenja.
English: The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Slovenian: Najpogostejše neželene reakcije v študijah nadzorovanega dodatnega zdravljenja so bile somnolenca, omotica in anoreksija.
English: At this higher dose level, juvenile rats showed a decrease in growth, learning, and developmental parameters.
Slovenian: Pri višjih ravneh se je pri podganjih mladičih pokazala upočasnitev parametrov rasti, učenja in razvoja.
English: P-gp substrate
Slovenian: Substrat P-gp
English: These increases are from about 5% to 8% for LBW, from about 8% to 10% for pre-term birth and from about 7% to 12% for SGA, all compared with mothers treated with lamotrigine monotherapy.
Slovenian: Ta povečanja so od približno 5 % do 8 % za majhno porodno telesno maso, od približno 8 % do 10 % za nedonošenost ali od približno 7 % do 12 % za dojenčke, ki so se rodili majhni za svojo gestacijsko starost, v primerjavi z materami, zdravljenimi z monoterapijo z lamotriginom.
English: System Organ Class (MedDRA terminology)
Slovenian: Organski sistem (terminologija MedDRA†)
English: Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/min); about 15 - 30 % of the dose is eliminated unchanged.
Slovenian: Ledvični očistek nespremenjenega zonisamida je relativno nizek (približno 3,5 ml/min), približno 15 - 30 % odmerka se iz telesa izloči nespremenjenega.
English: If you feel that the effect of Zonisamide Mylan is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če imate občutek, da je učinek zdravila Zonisamid Mylan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Physicians should discuss with patients and their carers the potential seriousness of heat stroke, situations in which it might arise, as well as action to take in the event of any signs or symptoms.
Slovenian: Zdravnik se mora z bolniki in njihovimi skrbniki pogovoriti o možni resnosti vročinske kapi, situacijah, v katerih se lahko pojavi, in o ukrepih, ki jih je treba storiti, če se pojavijo njeni znaki ali simptomi.
English: The apparent volume of distribution is about 1.1 - 1.7 l/kg in adults indicating that zonisamide is extensively distributed to tissues.
Slovenian: Volumen porazdelitve pri odraslih je med 1,1 - 1,7 l/kg, kar kaže na to, da se zonisamid močno porazdeljuje v tkiva.
English: Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).
Slovenian: Zdravnik bo spremljal ravni bikarbonata v krvi in ledvice vašega otroka (glejte tudi poglavje 4).
English: The long term effect of low bicarbonate levels on growth and development is unknown.
Slovenian: Dolgoročni učinek nizkih ravni bikarbonata na rast in razvoj ni znan.
English: The long term effect of weight loss in the paediatric population on growth and development is unknown.
Slovenian: Dolgoročni učinek izgube telesne mase pri pediatrični populaciji na rast in razvoj ni znan.
English: The incidence of decreased body weight is consistent across age groups (see section 4.8); however, given the potential seriousness of weight loss in children, weight should be monitored in this population.
Slovenian: Incidenca zmanjšanja telesne mase je bila v vseh starostnih skupinah konsistentna (glejte poglavje 4.8); vendar je treba zaradi možne resnosti izgube telesne mase pri otrocih telesno maso pri tej populaciji spremljati.
English: There have been cases of accidental and intentional overdose in adult and paediatric patients.
Slovenian: Znani so primeri slučajnega in namernega prevelikega odmerjanja pri odraslih in pediatričnih bolnikih.
English: Weight loss is potentially more serious in children (see section 4.4.
Slovenian: Izguba telesne mase je lahko pri otrocih bolj resna (glejte poglavje 4.4.
English: These effects were considered likely related to the decreased body weight and exaggerated pharmacologic effects of zonisamide at the maximum tolerated dose.
Slovenian: Menili so, da so ti učinki verjetno povezani z zmanjšano telesno maso in večjimi farmakološkimi učinki zonisamida pri največjem toleriranem odmerku.
English: • Give the child cold water to drink
Slovenian: • otroku dajte za piti mrzlo vodo.
English: Parent drug and SMAP can additionally be glucuronidated.
Slovenian: Izvorno zdravilo in SMAP se lahko dodatno glukuronidirata.
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing zonisamide (by gradual discontinuation or reduction of a therapeutic dose) as osteopenia may develop.
Slovenian: Če se metabolna acidoza razvije in vztraja, je treba razmisliti o zniževanju odmerka ali prekinitvi zdravljenja z zonisamidom (s postopno ukinitvijo ali zniževanjem terapevtskega odmerka), saj se lahko razvije osteopenija.
English: Children are most at risk especially in hot weather.
Slovenian: Otroci so tveganju najbolj izpostavljeni, ko je vroče.
English: If any of these applies to you, tell your doctor before you take Zonisamide Mylan.
Slovenian: Če kar koli od zgoraj navedenega velja za vas, to povejte zdravniku, preden začnete jemati zdravilo Zonisamid Mylan.
English: In some cases of weight decrease there was a delay in transition to the next Tanner stage and in bone maturation.
Slovenian: V nekaterih primerih zmanjšanja telesne mase je prišlo tudi do zakasnitve pri prehodu do naslednje stopnje po Tannerju in zorenju kosti.
English: Other medicines and Zonisamide Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Zonisamid Mylan Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Zonisamide lowers the 28-day average seizure frequency and the decrease is proportional (log-linear) to zonisamide average concentration.
Slovenian: Zonisamid zmanjšuje 28-dnevno povprečno pogostnost epileptičnih napadov, zmanjšanje pa je sorazmerno (log-linearno) glede na povprečne koncentracije zonisamida.
English: 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.
Slovenian: Starost (≥ 12 let) in spol, po prilagoditvi odmerkov zaradi telesne mase, nimata očitnih učinkov na izpostavljenost zonisamidu pri epileptičnih bolnikih v stanju dinamičnega ravnovesja.
English: There are no clinical data available on the effects of zonisamide on human fertility.
Slovenian: Ni kliničnih podatkov o vplivu zonisamida na plodnost pri ljudeh.
English: Heat stroke requiring hospital treatment and leading to death has been reported.
Slovenian: Poročali so o vročinski kapi, ki je zahtevala bolnišnično zdravljenje in je povzročila smrt.
English: Metabolic acidosis
Slovenian: Metabolna acidoza
English: Zonisamide Mylan must be added to existing therapy for paediatric patients aged 6 years and above.
Slovenian: Zdravilo Zonisamid Mylan je treba dodati obstoječemu zdravljenju pediatričnih bolnikov, starih 6 let in več.
English: Patients of weight > 55 kg
Slovenian: Bolniki s telesno maso > 55 kg
English: Your doctor may decide that you should stop using Zonisamide Mylan.
Slovenian: Mogoče bo zdravnik odločil, da morate prenehati jemati zdravilo Zonisamid Mylan.
English: • with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.
Slovenian: • Z drugimi antiepileptiki za zdravljenje epileptičnih napadov pri odraslih, mladostnikih in otrocih, starih 6 let in več.
English: Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Slovenian: Nekateri bolniki, zlasti tisti, ki ne jemljejo zdravil, ki so induktorji CYP3A4, se bodo morda odzvali že na manjše odmerke.
English: The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
Slovenian: Režim odmerjanja je 6-8 mg/kg/dan do največjega odmerka 500 mg/dan.
English: In adults, efficacy has been demonstrated with zonisamide in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Slovenian: Pri odraslih je bila učinkovitost zonisamida prikazana v štirih dvojno slepih s placebom kontroliranih študijah, ki so trajale do 24 tednov z odmerjanjem enkrat ali dvakrat na dan.
English: Such electrolyte imbalance has been observed with the use of zonisamide in placebo-controlled clinical trials and in the post-marketing period.
Slovenian: Takšno elektrolitsko neravnovesje so opazovali po uporabi zonisamida v s placebom kontroliranih kliničnih preskušanjih in v obdobju trženja.
English: Complex partial
Slovenian: Kompleksni parcialni
English: The safety and efficacy of zonisamide in children aged below 6 years or those below 20 kg have not yet been established.
Slovenian: Varnost in učinkovitost zonisamida pri otrocih, starih manj kot 6 let ali s telesno maso manj kot 20 kg, še nista bili dokazani.
English: Effect of zonisamide on cytochrome P450 enzymes
Slovenian: Učinek zonisamida na encime citokroma P450
English: It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Slovenian: Je antiepileptično zdravilo s šibko karboanhidrazno aktivnostjo in vitro.
English: There are limited data from the use of zonisamide in pregnant women.
Slovenian: Podatkov o uporabi zonisamida pri nosečnicah je malo.
English: Sulfonamide reactions
Slovenian: Reakcije na sulfonamid
English: Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in this population (see section 4.4 - Metabolic acidosis for full warning; see section 4.8 for incidence of low bicarbonate).
Slovenian: Pri tej populaciji je treba ustrezno oceniti in spremljati ravni bikarbonata v serumu (za vsa opozorila glejte poglavje 4.4 - Metabolna acidoza; glejte poglavje 4.8 za incidenco nizke ravni bikarbonata).
English: Women planning a pregnancy should meet with their specialists to reassess treatment with zonisamide and to consider other therapeutic options.
Slovenian: Ženske, ki načrtujejo zanositev, se morajo posvetovati z zdravnikom specialistom, da se ponovno oceni zdravljenje z zonisamidom in razmisli o drugih možnostih zdravljenja.
English: Adults - recommended dosage escalation and maintenance regimen
Slovenian: Odrasli - priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka
English: Heat stroke and dehydration Preventing overheating and dehydration in children
Slovenian: Vročinska kap in dehidracija Preprečevanje pregretja in dehidracije pri otrocih
English: Subjects were randomised to carbamazepine and zonisamide received treatment for a duration of up to 24 months depending on response.
Slovenian: Osebe so bile randomizirane v skupini s karbamazepinom in zonisamidom in so zdravilo glede na odziv prejemale do 24 mesecev.
English: The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients.
Slovenian: Zgoraj navedeni opozorila in previdnostni ukrepi veljajo tudi za mladostnike in pediatrične bolnike.
English: 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.
Slovenian: • zaviranje CYP3A4: Glede na klinične podatke znani specifični ali nespecifični zaviralci CYP3A4 nimajo klinično pomembnih učinkov na farmakokinetične parametre izpostavljenosti zonisamidu.
English: Zonisamide Mylan may be taken as monotherapy or added to existing therapy in adults.
Slovenian: Zdravilo Zonisamid Mylan se lahko uporablja kot monoterapija ali se doda k obstoječi terapiji pri odraslih.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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'').
English: The most common side effects of Zonisamide Mylan are mild.
Slovenian: Najpogostejši neželeni učinki zdravila Zonisamid Mylan so blagi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.
Slovenian: 500 mg za otroka s telesno maso več kot 55 kg (kateri odmerek je manjši) enkrat na dan.
English: - The recommended dose is 300 mg once a day.
Slovenian: • Priporočeni odmerek je 300 mg enkrat na dan.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Slovenian: Dodatno zdravljenje - z induktorji CYP3A4 (glejte poglavje 4.5)