natgillin/translations-raw huggingface dataset:
Children and adolescents Talk to your doctor about the following risks:
Otroci in mladostniki Z zdravnikom se posvetujte o naslednjih tveganjih:
In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Poleg tega obstajajo obširne izkušnje z zonisamidom v obdobju trženja na Japonskem od leta 1989 in v ZDA od leta 2000.
Most reports occurred during periods of warm weather.
Večina teh primerov se je zgodila v obdobjih toplega vremena.
Steady state was achieved within 13 days.
Stanje dinamičnega ravnovesja je bilo doseženo v trinajstih dneh.
They occur during the first month of treatment and usually decrease with continued treatment.
Pojavljajo se med prvim mesecem zdravljenja in običajno z nadaljevanjem zdravljenja izzvenijo.
Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.
Tega zdravila ne dajajte otrokom, starim manj kot 6 let, saj za to starostno skupino ni znano, ali so morebitne koristi večje od tveganj.
Note: * All doses are once daily.
Opomba: * Vsi odmerki so enkrat na dan.
General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Indicirana je splošna podporna terapija, vključno s pogostim spremljanjem vitalnih znakov in skrbnim opazovanjem.
Altogether, data on effects on long-term growth and development are limited.
Na splošno so podatki o učinku na dolgoročno rast in razvoj omejeni.
Suicide ideation and behaviour
Samomorilno razmišljanje in vedenje
Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.
Prepričajte se, da ste o tveganjih in koristih uporabe zonisamida za epilepsijo med nosečnostjo v celoti obveščeni.
Zonisamide was not genotoxic and has no carcinogenic potential.
Zonisamid ni genotoksičen in nima kancerogenega potenciala.
• Keep the child's skin cool with water
• otrokovo kožo hladite z vodo,
PP = Per Protocol Population; ITT = Intent To Treat Population *Primary endpoint
PP = populacija po protokolu; ITT = populacija z namenom zdravljenja *Primarni opazovani dogodek
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for zonisamide.
Mehanizem tveganja še ni znan, vendar razpoložljivi podatki ne izključujejo možnosti povečanega tveganja pri zonisamidu.
Paediatric Population).
Pediatrična populacija).
Tell your doctor as this may need to be monitored.
O tem obvestite zdravnika, ker bo mogoče to treba spremljati;
Studies in animals have shown changes in fertility parameters.
Študije na živalih so pokazale spremembe v parametrih plodnosti.
When a child is taking zonisamide:
Če otrok jemlje zonisamid:
incontinence), status epilepticus (prolonged or repeated seizures)
inkontinenca), epileptični status (dolgotrajen ali ponavljajoč se napad krčev);
The dose should be titrated on the basis of clinical effect.
Odmerek je treba titrirati na podlagi kliničnega učinka.
Do not try to drive.
V tem času ne vozite avtomobila.
- Zonisamide Mylan can be taken once or twice daily, as instructed by your doctor.
- Zdravilo Zonisamid Mylan lahko jemljete enkrat ali dvakrat na dan, kot vam je naročil zdravnik.
Titration Phase
Faza titriranja
• Body weight: You should monitor your child's weight every month and see your doctor as soon as possible if your child is not gaining enough weight.
• Telesna masa: vsak mesec spremljajte telesno maso svojega otroka in pojdite k zdravniku takoj, ko lahko, če otrok ne pridobiva ustrezno na telesni masi.
In these cases it is therefore recommended that the zonisamide total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of zonisamide (25 mg, 50 mg and 100 mg).
Zato v teh primerih priporočajo, naj se celotni odmerek zonisamida zaokroži navzgor ali navzdol do najbližjega razpoložljivega odmerka, ki ga je možno doseči z jakostmi kapsul zonisamida, ki so komercialno na voljo (25 mg, 50 mg in 100 mg).
At a higher dose level (2-3-fold systemic exposure compared to therapeutic exposure) renal histopathological effects were more severe and only partially reversible.
Pri višjih ravneh odmerka (2-3-kratna sistemska izpostavljenost v primerjavi s terapevtsko izpostavljenostjo) so bili ledvični histopatološki učinki resnejši in le delno reverzibilni.
- Do not chew the capsules.
- Kapsul ne žvečite.
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Some patients may respond to lower doses.
Nekateri bolniki se lahko odzovejo že na manjše odmerke.
Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.
Primer: Otrok, ki tehta 25 kg, naj vzame 25 mg enkrat na dan prvi teden, nato pa poveča dnevni odmerek za 25 mg na začetku vsakega tedna, dokler ni dosežen dnevni odmerek med 150 do 200 mg.
Subjects who were seizure-free for 26 weeks at a target dose level continued on this dose for another 26 weeks.
Osebe, ki 26 tednov s ciljnim odmerkom niso imele epileptičnega napada, so s tem odmerkom nadaljevale še 26 tednov.
Usual Maintenance Dose
Običajni vzdrževalni odmerek
None of these risk factors can reliably predict stone formation during zonisamide treatment.
Noben od teh dejavnikov tveganj ne more zanesljivo napovedati nastanka kamnov med zdravljenjem z zonisamidom.
- If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and half in the evening.
- Če jemljete zdravilo Zonisamid Mylan dvakrat na dan, vzemite polovico dnevnega odmerka zjutraj, drugo polovico pa zvečer.
You should not stop your treatment without discussing this with your doctor.
Ne prenehajte zdravljenja, ne da bi se pred tem posvetovali z zdravnikom.
Zonisamide exposure increases with time until steady state is achieved by approximately 8 weeks.
Izpostavljenost zonisamidu s časom narašča, dokler ni doseženo stanje dinamičnega ravnovesja po približno 8 tednih.
All these effects and specifically weight loss may have deleterious implications for growth and development, and may lead to general deterioration of health.
Vsi neželeni učinki, še zlasti izguba telesne mase, imajo lahko škodljiv vpliv na rast in razvoj ter povzročijo splošno krhanje zdravja.
Treatment Regimen
Režim zdravljenja
Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Farmakoterapevtska skupina: Antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX15
• The child should stay cool especially in hot weather
• mora ostati hladen, zlasti ob vročem vremenu;
• Take the child to a cool, shaded place
• otroka spravite na hladno in v senco,
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike nadzirati glede znakov samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Effect of food Zonisamide Mylan may be taken with or without food (see section 5.2).
Učinki hrane Zdravilo Zonisamid Mylan se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulfonamides.
Preobčutljivost na učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, ali na sulfonamide.
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 has a long elimination half-life so its effects may be persistent.
Zonisamid ima dolgo razpolovno dobo izločanja, zato njegovi učinki lahko vztrajajo.
• The child must drink plenty of cold water
• mora piti veliko hladne vode,
The incidence of a decrease in body weight of 10% or more was 10.7% (see section 4.4).
Pogostnost zmanjšanja telesne mase za 10 % ali več je bila 10,7 % (glejte poglavje 4.4).
Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Simptomi vključujejo akutno zmanjšanje ostrine vida in/ali bolečine v očeh.
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.
Analiza združenih podatkov o varnosti pri 95 starejših osebah je pokazala relativno visoko pogostnost perifernega edema in pruritusa v primerjavi z odraslo populacijo.
• 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).
• 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
- are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
• če ste noseči ali lahko zanosite (za več informacij glejte poglavje "Nosečnost, dojenje in plodnost").
Date of first authorisation: 31 March 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 31. 03. 2016
The metabolites, which could not be detected in plasma, are devoid of anticonvulsant activity.
Presnovki, ki jih ni možno zaslediti v plazmi, nimajo antikonvulzivne aktivnost.
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.
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.
MonotherapyNewly diagnosed adult patients
MonoterapijaNa novo diagnosticirani odrasli bolniki
There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Za oceno morebitne povezave med odmerkom in trajanjem zdravljenja ter temi dogodki ni dovolj podatkov.
Preventing overheating and dehydration in children
Preprečevanje pregretja in dehidracije pri otrocih
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 %).
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.
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.
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).
Izguba telesne mase, ki povzroči poslabšanje splošnega stanja, in nejemanje zdravil proti epilepsiji sta bila povezana s smrtnim izidom (glejte poglavje 4.8).
Treatment includes discontinuation of zonisamide, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.
Zdravljenje vključuje ukinitev zonisamida, kolikor hitro je to mogoče po presoji lečečega zdravnika, in ustrezne ukrepe za znižanje znotrajočesnega tlaka.
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%.
Incidenca znatno neobičajno nizkega serumskega bikarbonata (znižanje na manj kot 17 mEq/l in za več kot 5 mEq/l) je bila 3,8 %.
Rifampicin is a potent CYP3A4 inducer.
Rifampicin je močan induktor CYP3A4.
- are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems.
• če ste mlajši kot 12 let, saj je pri vas morda večje tveganje za zmanjšano znojenje, vročinsko kap, pljučnico in težave z jetri.
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.
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.
Paediatric population (aged 6 years and above)
Pediatrična populacija (starost 6 let in več)
Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received zonisamide for at least 1 year.
V kliničnih študijah je zonisamid jemalo več kot 1.200 bolnikov, več kot 400 jih je zonisamid jemalo najmanj eno leto.
Generally, zonisamide-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.
Ponavadi se metabolna acidoza, ki jo sproži zonisamid, pojavi zgodaj v poteku zdravljenja, primeri pa se lahko pojavijo kadarkoli med zdravljenjem.
The incidence of marked decreases in weight of 20% or more was 0.7%.
Incidenca znatnega zmanjšanja telesne mase za 20 % ali več je bila 0,7 %.
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 nasičene vezave zonisamida na eritrocite.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnega razmišljanja ali vedenja.
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, omotica in anoreksija.
At this higher dose level, juvenile rats showed a decrease in growth, learning, and developmental parameters.
Pri višjih ravneh se je pri podganjih mladičih pokazala upočasnitev parametrov rasti, učenja in razvoja.
P-gp substrate
Substrat P-gp
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.
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.
System Organ Class (MedDRA terminology)
Organski sistem (terminologija MedDRA†)
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.
If you feel that the effect of Zonisamide Mylan is too strong or too weak, talk to your doctor or pharmacist.
Če imate občutek, da je učinek zdravila Zonisamid Mylan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
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.
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.
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.
Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).
Zdravnik bo spremljal ravni bikarbonata v krvi in ledvice vašega otroka (glejte tudi poglavje 4).
The long term effect of low bicarbonate levels on growth and development is unknown.
Dolgoročni učinek nizkih ravni bikarbonata na rast in razvoj ni znan.
The long term effect of weight loss in the paediatric population on growth and development is unknown.
Dolgoročni učinek izgube telesne mase pri pediatrični populaciji na rast in razvoj ni znan.
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.
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.
There have been cases of accidental and intentional overdose in adult and paediatric patients.
Znani so primeri slučajnega in namernega prevelikega odmerjanja pri odraslih in pediatričnih bolnikih.
Weight loss is potentially more serious in children (see section 4.4.
Izguba telesne mase je lahko pri otrocih bolj resna (glejte poglavje 4.4.
These effects were considered likely related to the decreased body weight and exaggerated pharmacologic effects of zonisamide at the maximum tolerated dose.
Menili so, da so ti učinki verjetno povezani z zmanjšano telesno maso in večjimi farmakološkimi učinki zonisamida pri največjem toleriranem odmerku.
• Give the child cold water to drink
• otroku dajte za piti mrzlo vodo.
Parent drug and SMAP can additionally be glucuronidated.
Izvorno zdravilo in SMAP se lahko dodatno glukuronidirata.
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.
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.
Children are most at risk especially in hot weather.
Otroci so tveganju najbolj izpostavljeni, ko je vroče.
If any of these applies to you, tell your doctor before you take Zonisamide Mylan.
Če kar koli od zgoraj navedenega velja za vas, to povejte zdravniku, preden začnete jemati zdravilo Zonisamid Mylan.
In some cases of weight decrease there was a delay in transition to the next Tanner stage and in bone maturation.
V nekaterih primerih zmanjšanja telesne mase je prišlo tudi do zakasnitve pri prehodu do naslednje stopnje po Tannerju in zorenju kosti.
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.
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.
Zonisamide lowers the 28-day average seizure frequency and the decrease is proportional (log-linear) to zonisamide average concentration.
Zonisamid zmanjšuje 28-dnevno povprečno pogostnost epileptičnih napadov, zmanjšanje pa je sorazmerno (log-linearno) glede na povprečne koncentracije zonisamida.
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 odmerkov zaradi telesne mase, nimata očitnih učinkov na izpostavljenost zonisamidu pri epileptičnih bolnikih v stanju dinamičnega ravnovesja.
There are no clinical data available on the effects of zonisamide on human fertility.
Ni kliničnih podatkov o vplivu zonisamida na plodnost pri ljudeh.
Heat stroke requiring hospital treatment and leading to death has been reported.
Poročali so o vročinski kapi, ki je zahtevala bolnišnično zdravljenje in je povzročila smrt.
Metabolic acidosis
Metabolna acidoza
Zonisamide Mylan must be added to existing therapy for paediatric patients aged 6 years and above.
Zdravilo Zonisamid Mylan je treba dodati obstoječemu zdravljenju pediatričnih bolnikov, starih 6 let in več.
Patients of weight > 55 kg
Bolniki s telesno maso > 55 kg
Your doctor may decide that you should stop using Zonisamide Mylan.
Mogoče bo zdravnik odločil, da morate prenehati jemati zdravilo Zonisamid Mylan.
• with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.
• Z drugimi antiepileptiki za zdravljenje epileptičnih napadov pri odraslih, mladostnikih in otrocih, starih 6 let in več.
Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Nekateri bolniki, zlasti tisti, ki ne jemljejo zdravil, ki so induktorji CYP3A4, se bodo morda odzvali že na manjše odmerke.
The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
Režim odmerjanja je 6-8 mg/kg/dan do največjega odmerka 500 mg/dan.
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.
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.
Such electrolyte imbalance has been observed with the use of zonisamide in placebo-controlled clinical trials and in the post-marketing period.
Takšno elektrolitsko neravnovesje so opazovali po uporabi zonisamida v s placebom kontroliranih kliničnih preskušanjih in v obdobju trženja.
Complex partial
Kompleksni parcialni
The safety and efficacy of zonisamide in children aged below 6 years or those below 20 kg have not yet been established.
Varnost in učinkovitost zonisamida pri otrocih, starih manj kot 6 let ali s telesno maso manj kot 20 kg, še nista bili dokazani.
Effect of zonisamide on cytochrome P450 enzymes
Učinek zonisamida na encime citokroma P450
It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Je antiepileptično zdravilo s šibko karboanhidrazno aktivnostjo in vitro.
There are limited data from the use of zonisamide in pregnant women.
Podatkov o uporabi zonisamida pri nosečnicah je malo.
Sulfonamide reactions
Reakcije na sulfonamid
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).
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).
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.