natgillin/translations-raw huggingface dataset:
All patients who develop a rash while taking zonisamide 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 zonisamida 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 povzročajo kožne izpuščaje.
If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of zonisamide be considered and appropriate treatment initiated.
Ob očitnem pankreatitisu in ob odsotnosti drugih očitnih razlogov je treba razmisliti o prenehanju zdravljenja z zonisamidom in začetkom ustreznega zdravljenja pankreatitisa.
Zonisamide must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Uporaba zonisamida med nosečnostjo ni dovoljena, razen kadar je to nujno potrebno in samo če se oceni, da možna korist upravičuje tveganje za plod.
Therefore, modification of zonisamide dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Zato prilagajanje odmerka zonisamida pri sočasnem zdravljenju z znanimi zaviralci CYP3A4 ni potrebno.
Absolute bioavailability is estimated to be approximately 100%.
Presnova prvega prehoda naj bi bila zanemarljiva, absolutna biološka uporabnost je približno 100 %.
Zonisamide Mylan can make you perspire less, which can cause your body temperature to increase.
Mogoče se boste zaradi zdravila Zonisamid Mylan manj znojili, zaradi česar se vam lahko zviša telesna temperatura.
CYP3A4-inducing agents; or with renal or hepatic impairment
- brez induktorjev CYP3A4 ali z okvaro ledvic ali jeter
Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation in adults
Dodatno zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih bolnikih
Zonisamide Mylan is indicated as:
Zdravilo Zonisamid Mylan je indicirano kot:
Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen Treatment Regimen
Pediatrična populacija (starost 6 let in več) - priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka
If substantial undesirable weight loss occurs, discontinuation of zonisamide should be considered.
V primeru znatne neželene izgube telesne mase je treba razmisliti o prekinitvi zdravljenja z zonisamidom.
Potential for zonisamide to affect other medicinal products Anti-epileptic medicinal products
Možni učinki zonisamida na druga zdravila
• The child must not take any of these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
• ne sme jemati nobenega od naslednjih zdravil: zaviralcev karbonanhidraze (kot sta topiramat in acetazolamid) in antiholinergičnih zdravil (kot so klomipramin, hidroksizin, difenhidramin,
Subjects who experienced a seizure were titrated to the next target dose i.e. 800 mg carbamazepine or 400 mg of zonisamide.
Osebe, ki so imele epileptični napad, so bile titrirane na naslednji ciljni odmerek, tj. 800 mg karbamazepina ali 400 mg zonisamida.
Subjects who experienced a further seizure were titrated to the maximal target dose of 1200 mg carbamazepine or 500 mg zonisamide.
Osebe, ki so imele še en epileptični napad, so bile titrirane na najvišji ciljni odmerek 1200 mg karbamazepina ali 500 mg zonisamida.
The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients.
Zdi se, da je tveganje za z zonisamidom inducirano metabolno acidozo večje in potek težji pri mlajših bolnikih.
• on its own to treat seizures in adults
• Kot samostojno zdravilo za zdravljenje epileptičnih napadov pri odraslih.
Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Oftalmološke ugotovitve lahko vključujejo miopijo, poplitvitev sprednjega prekata in očesno hiperemijo (rdečino) ter zvišan znotrajočesni tlak.
A 50% or greater reduction from baseline in seizure frequency during the 12-week stable dose period was seen in 50% of the zonisamide-treated subjects and 31% of the patients on placebo.
Pri 50 % bolnikov, zdravljenih z zonisamidom, in pri 31 % bolnikov, ki so prejemali placebo, so v 12-tedenskem obdobju s stabilnim odmerkom opazili 50-odstotno ali večje zmanjšanje pogostnosti epileptičnih napadov.
Zonisamide Mylan 25 mg and 50 mg are available in blister packs of 14, 28, 56 capsules and perforated unit dose blister packs of 14 x 1 capsules.
Zonisamid Mylan 25 mg in 50 mg trde kapsule so na voljo v pretisnih omotih s po 14, 28, 56 trdih kapsul in v perforiranih pretisnih omotih za posamezni odmerek s po 14 x 1 kapsulo.
Women of childbearing potential must use effective contraception during treatment with zonisamide, and for one month after discontinuation.
Ženske v rodni dobi morajo med zdravljenjem z zonisamidom in en mesec po zaključenem zdravljenju uporabljati učinkovito kontracepcijo.
What Zonisamide Mylan is and what it is used for 2.
Kaj je zdravilo Zonisamid Mylan in za kaj ga uporabljamo
Kidney stones have occurred in paediatric patients (see section 4.4 Kidney stones for full warning).
Pri pediatričnih bolnikih so se pojavili ledvični kamni (za vsa opozorila glejte poglavje 4.4 Ledvični kamni).
6 to 8 mg/kg/day (once a day)
6 do 8 mg/kg/dan (enkrat na dan)
What Zonisamide Mylan looks like and contents of the pack
Izgled zdravila Zonisamid Mylan in vsebina pakiranja
• Periodic safety update reports
Redno posodobljena poročila o varnosti zdravila (PSUR)
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih vročinska kap
The most common adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release were decreased bicarbonate, decreased appetite, and decreased weight.
Neželeni učinki, ki so jih v randomiziranem, kontroliranem preskušanju, v katerem so primerjali zonisamid s karbamazepinom s podaljšanim sproščanjem, najpogosteje opazili, so bili znižanje bikarbonata, zmanjšanje apetita in zmanjšanje telesne mase.
Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of zonisamide should be considered.
Vendar pa je treba ob sumu na jetrni dogodek oceniti delovanje jeter in razmisliti o prekinitvi zdravljenja z zonisamidom.
Do not breast-feed whilst taking, or for one month after stopping Zonisamide Mylan.
Ne dojite med zdravljenjem ter vsaj še mesec dni po končanem zdravljenju z zdravilom Zonisamid Mylan.
Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Pri psih, ki so bili izpostavljeni koncentracijam, podobnim kot v klinični uporabi, so opazili spremembe na jetrih (povečanje, temnorjavo obarvanje, rahlo povečanje hepatocitov s koncentričnimi lamelarnimi telesci v citoplazmi ter citoplazemska vakuolizacija), povezane s povečano presnovo.
Paediatric population (aged 6 years and above) - recommended down-titration schedule Weight
Pediatrična populaciija (starost 6 let in več) - priporočeni režim zmanjševanja odmerka
28 hard capsules 56 hard capsules 98 hard capsules 196 hard capsules
Pretisni omoti: 28 trdih kapsul 56 trdih kapsul 98 trdih kapsul 196 trdih kapsul
Unexplained rash
Nepojasnjen izpuščaj
In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
Pri bolnikih z ledvično okvaro je ledvični očistek enkratnega odmerka zonisamida pozitivno koreliral z očistkom kreatinina.
Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonisamide Mylan may be required.
Pri zdravljenju bolnikov z blažjo do zmerno jetrno okvaro je potrebna potrebna previdnost in počasnejše prilagajanje odmerka zdravila Zonisamid Mylan.
Limited data indicate that pharmacokinetics in children and adolescents dosed to steady state at 1, 7 or 12 mg/kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Otroci in mladostniki (5 - 18 let): Omejeni podatki kažejo, da je farmakokinetika pri otrocih in mladostnikih v stanju dinamičnega ravnovesja pri odmerkih 1,7 ali 12 mg/kg na dan v deljenih odmerkih podobna kot pri odraslih po prilagoditvi glede na telesno maso.
Secondary Tonic-Clonic Generalized Tonic-Clonic
Sekundarni tonično-klonični
Zonisamide Mylan may be used:
Zdravilo Zonisamid Mylan se lahko uporablja:
Urine analysis abnormal
• nenormalni izvidi preiskave urina.
The combination of zonisamide 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.
Kombinacija zonisamida z drugimi zdravili, ki lahko povzročijo urolitiazo, lahko poveča nevarnost za nastanek ledvičnih kamnov.
Nephrolithiasis may lead to chronic kidney damage.
Nefrolitiaza lahko trajno poškoduje ledvice.
- This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
• Ta odmerek se lahko povečuje v korakih po največ 1 mg na kg telesne mase v enotedenskih do dvotedenskih intervalih.
These effects are unlikely to be of clinical significance when zonisamide 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 zonisamide 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 zonisamida.
The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Mehanizem delovanja zonisamida še ni popolnoma raziskan, vendar pa verjetno deluje na napetostno odvisne natrijeve in kalcijeve kanalčke in s tem prepreči sinhronizirano proženje nevronov.
Caution should be used when treating patients with history of eye disorders with zonisamide.
Pri zdravljenju bolnikov z anamnezo očesnih bolezni z zonisamidom je potrebna previdnost.
Increase at weekly intervals in increments of 1 mg/kg
Povečevanje v tedenskih intervalih po 1 mg/kg
What Zonisamide Mylan is and what it is used for Zonisamide Mylan contains the active substance zonisamide, and is used as an antiepileptic medicine.
Zdravilo Zonisamid Mylan vsebuje učinkovino zonisamid in se uporablja kot antiepileptično zdravilo.
Zonisamide must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, ne smejo uporabljati zonisamida, razen kadar je to nujno potrebno in samo če se oceni, da možna korist upravičuje tveganje za plod.
Potential medicinal product interactions affecting zonisamide In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
V kliničnih študijah sočasno zdravljenje z lamotriginom ni imelo očitnih učinkov na farmakokinetiko zonisamida.
Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma.
Koncentracije v materinem mleku so podobne tistim v plazmi pri materi.
Very rare (may affect up to 1 in 10,000 people): - memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever,
• izguba spomina, koma, nevroleptični maligni sindrom (nezmožnost gibanja, znojenje, vročina,
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 zonisamid 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 zonisamidom takoj prekiniti.
Pharmacodynamic effects The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
Antikonvulzivna aktivnost zonisamida je bila ocenjena v več modelih in na več vrstah tako z induciranimi kot prirojenimi epileptičnimi napadi.
Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Bolezni imunskega sistema preobčutljivost preobčutljivostni sindrom zaradi zdravila kožni izpuščaj z eozinofilijo in s sistemskimi simptomi
CYP3A4-inducing agents
- brez induktorjev CYP3A4
Increase at weekly intervals in increments of 100 mg
Povečevanje v tedenskih intervalih po 100 mg
Seizure Sub-type (6 month seizure freedom-PP population) All partial
Podtip epileptičnega napada (6 mesecev brez epileptičnega napada - populacija PP)
Acute myopia and secondary angle closure glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Akutna miopija in sekundarni glavkom zaprtega zakotja Pri odraslih in pediatričnih bolnikih, ki so prejemali zonisamid, so poročali o sindromu akutne miopije, povezane s sekundarnim glavkomom zaprtega zakotja.
Unit Dose Blisters: 56 x 1 hard capsules
Pretisni omoti za posamezni odmerek: 56 x 1 trda kapsula
Unit Dose Blisters: 14 x 1 hard capsules
Pretisni omoti za posamezni odmerek: 14 x 1 trda kapsula
Anhidrosis Erythema multiforme Stevens-Johnson syndrome
Bolezni kože in podkožja izpuščaj pruritus alopecija anhidroza multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza
† MedDRA version 13.1
† Različica MedDRA 13.1 Dodatne informacije za posebne skupine bolnikov
Aggression Suicidal ideation Suicide attempt
• jeza, agresivnost, samomorilne misli, poskus samomora;
Method of administration Zonisamide Mylan hard capsules are for oral use.
Zdravilo Zonisamid Mylan trde kapsule se uporablja peroralno.
Mylan Pharmaceuticals S.L.
España Mylan Pharmaceuticals, S.L
This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Ta sindrom je lahko povezan s supraciliarnim izlivom, kar povzroči premik leče in šarenice navzpred, s sekundarnim glavkomom zaprtega zakotja.
- This may be increased by up to 100 mg at intervals of two weeks.
• Ta odmerek se lahko povečuje v korakih po največ 100 mg v dvotedenskih intervalih.
300 mg per day (once a day).
300 mg na dan (enkrat na dan).
Therefore use in patients with severe hepatic impairment is not recommended.
Zdravila pri bolnikih z jetrno okvaro niso preizkušali, zato uporabe pri bolnikih s hudo jetrno okvaro ne priporočamo.
Zonisamide Mylan belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Zdravilo Zonisamid Mylan spada v skupino zdravil (sulfonamidi), ki lahko povzročajo hude alergijske reakcije, hude kožne izpuščaje in bolezni krvi, kar je zelo redko lahko usodno.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema levkopenija trombocitopenija
Patients of weight 20 to 55 kga
1. teden 2. do 8. teden Bolniki s telesno maso 20 do 55 kga
PVC-PVdC/Aluminium foil blisters in cardboard cartons containing 28, 56, 98 and 196 capsules.
PVC/PVdC/aluminijevi pretisni omoti v škatli s po 28, 56,98 in 196 trdih kapsul.
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 Zonisamide Mylan might be required.
Pri zdravljenju bolnikov z ledvično okvaro z zdravilom Zonisamid Mylan je potrebna previdnost, saj so o zdravljenju teh bolnikov na voljo le omejeni podatki, zato je pri njih potrebno počasnejše prilagajanje odmerka.
Twelve months seizure freedom PP-population ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
≤ 4 epileptični napadi med 3mesečnim izhodiščnim obdobjem > 4 epileptični napadi med 3mesečnim izhodiščnim obdobjem
If you forget to take Zonisamide Mylan - If you forget to take a dose, don't worry: take the next dose when it is due.
• Če ste pozabili vzeti odmerek zdravila Zonisamid Mylan, ne skrbite.
There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with zonisamide has been achieved in the add-on situation, in order to reach monotherapy with zonisamide.
Za prehod z dodatne terapije na monoterapijo z zonisamidom z ukinitvijo drugih antiepileptičnih zdravil po tem, ko z zonisamidom dosežemo nadzor nad napadi, ni dovolj podatkov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Zonisamide Mylan 25 mg hard capsules
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zonisamid Mylan 25 mg trde kapsule
Zonisamide should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Pri odraslih bolnikih, sočasno zdravljenih z zaviralci karboanhidraze, na primer topiramatom ali acetazolamidom, moramo zonisamid uporabljati previdno, ker ni na voljo zadostnih podatkov, da bi lahko izključili možno farmakodinamično interakcijo (glejte poglavje 4.4).
Adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release System Organ Class (MedDRA terminology†)
Neželeni učinki, ki so jih v randomiziranem, kontroliranem preskušanju monoterapije, v katerem so primerjali zonisamid s karbamazepinom s podaljšanim sproščanjem
Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Psihiatrične motnje vznemirjenje depresija nespečnost nihanje razpoloženja tesnoba stanje zmedenosti akutna psihoza agresija samomorilne misli halucinacije
4.2 Posology and method of administration
4.2 Odmerjanje in način uporabe Odmerjanje-odrasli
Zonisamide should be used with caution in adult patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate or acetazolamide, as there are insufficient data to rule out a pharmacodynamic interaction (see also section 4.4 Paediatric Population and section 4.5).
Previdnost pri uporabi zonisamida je potrebna pri odraslih bolnikih, ki sočasno jemljejo zaviralce karboanhidraze, kot na primer topiramat ali acetazolamid, ker je na voljo premalo podatkov, da bi lahko izključili farmakodinamične interakcije (glejte tudi poglavje 4.4 Pediatrična populacija in poglavje 4.5).
Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
zonisamid karbamazepin n (populacija ITT) Šest mesecev brez epileptičnega napada razl.
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.
Nephrolithiasis Calculus urinary Hydronephrosis Renal failure
Bolezni sečil nefrolitiaza kamni v sečilih hidronefroza ledvična odpoved nenormalnosti urina
These studies show that the median reduction in partial seizure frequency is related to zonisamide dose with sustained efficacy at doses of 300-500 mg per day.
Te študije kažejo, da je srednje znižanje pogostosti parcialnih epileptičnih napadov povezano z odmerkom zonisamida.
Weight decreased Blood creatinine phosphokinase increased Alanine aminotransferase increased
Preiskave znižan bikarbonat zmanjšanje telesne mase zvišanje kreatin-kinaze v krvi zvišanje alaninaminotransferaze zvišanje aspartataminotransferaze neobičajna analiza urina
Zonisamide should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.5).
Zonisamida se pri pediatričnih bolnikih ne sme uporabljati sočasno z drugimi zaviralci karboanhidraze, kot sta topiramat in acetazolamid (glejte poglavje 4.5).
If you are younger than 6 years old, Zonisamide Mylan is not recommended for you - are elderly, as your dose of Zonisamide Mylan may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonisamide Mylan (see section 4 Possible Side Effects) - suffer from liver problems, as your dose of Zonisamide Mylan may need adjusting - have eye problems such as glaucoma - suffer from kidney problems as your dose of Zonisamide Mylan may need adjusting - have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
• če ste starejši, saj bo vaš odmerek zdravila Zonisamid Mylan morda potrebno prilagoditi in ker se vam utegne med jemanjem zdravila Zonisamid Mylan verjetneje pojaviti alergijska reakcija, hud kožni izpuščaj, oteklost stopal in nog ter srbenje (glejte poglavje 4, Možni neželeni učinki);
Hypokalaemia Metabolic acidosis Renal tubular acidosis
Presnovne in prehranske motnje anoreksija hipokaliemija metabolna acidoza renalna tubulna cidoza
Serious immune based adverse reactions that are associated with medicinal products containing a sulfonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see section 4.4).
Z zdravili, ki vsebujejo sulfonamidno skupino, so povezani resni neželeni učinki imunskega izvora, ki vključujejo izpuščaj, alergijske reakcije in večje hematološke motnje, vključno z aplastično anemijo, ki so zelo redko lahko usodni (glejte poglavje 4.4).
1 mg/kg/day (once a day)
1 mg/kg/dan (enkrat na dan)
Kidney stones
Ledvični kamni
Therefore, withdrawal of concomitant anti-epileptic medicinal products must be undertaken with caution.
Zato se je treba sočasnemu jemanju teh zdravil izogibati.
Adverse reactions associated with zonisamide obtained from adjunctive use clinical studies and post-marketing surveillance System Organ
Neželeni učinki, povezani z zonisamidom, iz klinične študije dodatnega zdravljenja in opazovanja v obdobju trženja zdravila
Week 1 + 2 Week 3 + 4 Week 5 to 10
+ 4. teden 5. do 10. teden
Black iron oxide (E172) Potassium hydroxide
Tiskarsko črnilo šelak črni železov oksid (E172) kalijev hidroksid
14 hard capsules 28 hard capsules 56 hard capsules
Pretisni omoti: 14 trdih kapsul 28 trdih kapsul 56 trdih kapsul
Increase at twoweekly intervals in increments of up to 100 mg
Povečanje v dvotedenskih intervalih po največ 100 mg
Serious immune based adverse reactions that are associated with medicinal products containing a sulfonamide 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 s smrtnim izidom.
Fatigue Pyrexia Irritability
Splošne težave in spremembe na mestu aplikacije utrujenost pireksija razdražljivost
PVC-PVdC/Aluminium foil blisters in cardboard cartons containing 14, 28 and 56 capsules.
PVC/PVdC/aluminijevi pretisni omoti v škatli s po 14, 28 in 56 trdimi kapsulami.
Increase at twoweekly intervals in increments of 1 mg/kg
Povečanje v dvotedenskih intervalih po največ 1 mg/kg