FrancophonIA/ELRC3.0 huggingface dataset:
English: Eurartesim 320 mg/40 mg tablets piperaquine tetraphosphate / artenimol
Slovenian: IME ZDRAVILA Eurartesim 320 mg/40 mg tablete piperakin tetrafosfat/artenimol
English: Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 160 mg piperakin tetrafosfata (v obliki tetrahidrata; PKP) in 20 mg artenimola.
English: Respiratory tract infection Ear infection
Slovenian: P. falciparum okužba dihal okužba ušesa
English: Talk to your doctor or pharmacist before taking this medicine if you or your child:
Slovenian: Pred začetkom jemanja zdravila Eurartesim se posvetujte z zdravnikom ali farmacevtom, če:
English: Contents of the pack and other information What Eurartesim contains
Slovenian: Kaj vsebuje zdravilo Eurartesim
English: Thrombocytopenia Leukopenia/neutrope nia
Slovenian: Okvarjeno delovanje jeter in ledvic
English: Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 320 mg piperakin tetrafosfata (v obliki tetrahidrata; PKP) in 40 mg artenimola.
English: EU/2/11/127/001 Recuvyra 50 mg/ml Transdermal
Slovenian: EU/2/11/127/001 Recuvyra 50 mg/ml transdermalna transdermalna viala (steklena)
English: Invented Name administration
Slovenian: Izmišljeno ime
English: 1 vial + 1 adapter + 15 syringes + 15 applicator tips
Slovenian: 1 viala + 1 adapter + 15 brizg + 15 aplikacijskih nastavkov
English: Packaging Content Package size Withdrawal period
Slovenian: Ovojnina Vsebina Velikost pakiranja Karenca
English: N/A
Slovenian: 10 ml
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 15 July 2016
Slovenian: Datum prve odobritve: 26. avgust 2011 Datum zadnjega podaljšanja: 15. julij 2016
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Slovenian: CLcr je prilagojen na telesno površino (BSA- »body surface area«) na sledeč način:
English: Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Slovenian: Zdravilo Levetiracetam Teva morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
English: You may take Levetiracetam Teva with or without food.
Slovenian: Levetiracetam Teva lahko vzamete s hrano ali brez nje.
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Slovenian: *Prevalenca je bistveno višja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki
English: This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
Slovenian: To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60% glede na običajno koncentracijo pred nosečnostjo).
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Slovenian: • če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Slovenian: Ne smete voziti ali upravljati stroev, dokler ni potrjeno, da ni vpliva na vašo sposobnost izvajanja teh dejavnosti.
English: No data on the interaction of levetiracetam with alcohol are available.
Slovenian: Podatkov o interakciji levetiracetama z alkoholom ni na voljo.
English: There was no effect on embryomortality and no increased incidence of malformations.
Slovenian: Vpliva na umrljivost zarodkov in povečanja pojava malformacij ni bilo.
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Slovenian: < 1/100); redki: (≥ 1/10.000 do < 1/1.000) in zelo redki: (< 1/10.000).
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.
Slovenian: Ne jemljite makrogola (zdravilo, ki se uporablja kot laksativ) eno uro pred in eno uro po jemanju levetiracetama, ker lahko zmanjša učinek levetiracetama.
English: Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Slovenian: Zaradi tega se makrogola ne sme jemati peroralno eno uro pred in eno uro po jemanju levetiracetama.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Slovenian: Preden začnete zdravilo jemati vi ali vaš otrok, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9 % of the dose).
Slovenian: Eden nastane s hidroksilacijo pirolidonskega obroča (1,6 % odmerka), drugi z odprtjem pirolidonskega obroča (0,9 % odmerka).
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilnega razmišljanja ali vedenja.
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Slovenian: Levetiracetam se uporablja pri vrsti epilepsije, kjer krči v začetku prizadanejo samo eno stran možganov, kasneje pa se lahko razširijo na večje površine na obeh straneh možganov (parcialni napadi s sekundarno generalizacijo ali brez nje).
English: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet that is to say essentially `sodium-free ´.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obloženo tableto, kar v bistvu pomeni ‘brez natrija'.
English: Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
English: • a more severe form of rash causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis)
Slovenian: • hujšo obliko izpuščaja, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza)
English: • If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Slovenian: • če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti se posvetujte z zdravnikom.
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Slovenian: Ta učinek je bil izrazit pri mlajših dojenčkih, z naraščanjem starosti je upadal in postal zanemarljiv okoli
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Slovenian: Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti: (≥ 1/10); pogosti: (≥ 1/100 do < 1/10); občasni: (≥ 1/1.000 do
English: However, if levetiracetam treatment is needed during breast-feeding, the benefit/risk of the treatment should be weighed considering the importance of breast-feeding.
Slovenian: Če je zdravljenje z levetiracetamom v obdobju dojenja potrebno, se mora pretehtati razmerje med koristjo in tveganjem zdravljenja glede na pomembnost dojenja.
English: You should continue Levetiracetam Teva treatment for as long as your doctor has told you.
Slovenian: Levetiracetam Teva morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Slovenian: Učinkovitost dializne ekstrakcije levetiracetama je 60 %, primarnega presnovka pa 74 %.
English: What you need to know before you take Levetiracetam Teva Do not take Levetiracetam Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Teva Ne jemljite zdravila Levetiracetam Teva
English: ks = 0.45 in Term infants to 1 year old; ks = 0.55 in Children to less than 13 years and in adolescent female; ks = 0.7 in adolescent male
Slovenian: ks = 0,45 pri dojenčkih do 1 leta starosti; ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah;
English: The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Slovenian: Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Slovenian: In vitro študije so pokazale, da levetiracetam vpliva na nivo Ca2+ znotraj nevrona preko delne inhibicije Ca2+ kanalov tipa N in zmanjšanjem sproščanja Ca2+ iz zalog znotraj nevrona.
English: • Dose in adults and adolescents (from 16 years of age):
Slovenian: • Odmerjanje pri odraslih in mladostnikih (od 16 leta starosti:)
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK United Kingdom
Slovenian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK Velika Britanija
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Slovenian: Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kot na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Slovenian: Rezultati, povezani z vedenjskimi in emocionalnimi funkcijami, kažejo pri bolnikih, ki se zdravijo z levetiracetamom, poslabšanje agresivnega obnašanja, ki se izmeri na standardiziran in sistematičen način z uporabo validiranega merskega instrumenta (CBCL - Achenbach Child Behavior Checklist).
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Slovenian: Predmarketinški podatki iz kliničnih študij, izvedenih pri odraslih, kažejo, da levetiracetam ne vpliva na serumsko koncentracijo drugih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona) in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2 % (95 % CI: -7.8 8.2).
Slovenian: 73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR), je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95 % CI: 7,8-8,2).
English: What Levetiracetam Teva is and what it is used for What you need to know before you take Levetiracetam Teva How to take Levetiracetam Teva Possible side effects
Slovenian: Kaj je zdravilo Levetiracetam Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Teva Kako jemati zdravilo Levetiracetam Teva
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Slovenian: • za samostojno zdravljenje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
English: Levetiracetam Teva contains Sodium
Slovenian: Levetiracetam Teva vsebuje natrij
English: The daily dose must be individualised according to renal function.
Slovenian: Dnevni odmerek je treba prilagoditi individualno glede na delovanje ledvic.
English: Swallow Levetiracetam Teva tablets with a sufficient quantity of liquid (e.g. a glass of water).
Slovenian: Način uporabe Tablete zdravila Levetiracetam Teva zaužijte z dovolj tekočine (npr. s kozarcem vode).
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO
English: 74770 Opava-Komarov Czech Republic
Slovenian: 74770 Opava-Komarov
English: What Levetiracetam Teva is and what it is used for
Slovenian: Kaj je zdravilo Levetiracetam Teva in za kaj ga uporabljamo
English: Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Slovenian: Največjo koncentracijo v plazmi (Cmax) dosežemo 1,3 ure po odmerku.
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Slovenian: Neželeni učinki, ki jih niso opazili v kliničnih študijah, opazili pa so jih v študijah pri podganah in v manjši meri pri miših (pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti) ter imajo možen pomen za klinično uporabo, so naslednji: jetrne spremembe, ki kažejo na prilagoditveni odgovor, kot so povečanje mase jeter in centrolobularna hipertrofija, maščobna infiltracija in zvišanje jetrnih encimov v plazmi.
English: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Slovenian: Varnost in učinkovitost levetiracetama pri otrocih in mladostnikih, mlajših od 16 let, pri samostojnem zdravljenju nista bili dokazani.
English: • symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
Slovenian: • simptome kot so nizek volumen urina, utrujenost, slabost, bruhanje, zmedenost in otekanje nog, gležnjev ali stopal saj so lahko to znaki nenadnega zmanjšanja delovanja ledvic
English: At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Slovenian: Pri 3600 mg/kg/dan se je samo v eni od dveh študij embriofetalnega razvoja telesna masa plodu rahlo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Slovenian: • široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom)
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Slovenian: Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalov, povzročeno z Zn2+ in β- karbolini.
English: - The active substance is levetiracetam.
Slovenian: - Učinkovina je levetiracetam.
English: In all of the above cases an oral solution should be used.
Slovenian: V vseh zgoraj naštetih primerih se priporoča uporaba peroralne raztopine.
English: In a pooled analysis, the percentage of patients who achieved 50 % or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7 %, 31.6 % and 41.3 % for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Slovenian: Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50- ali več odstotno zmanjšanje pogostnosti napadov parcialnega izvora na teden pri stalnem odmerku (12/14 tednov), je bil 27,7 % pri bolnikih, ki so prejemali 1000 mg, 31,6 % pri bolnikih, ki so prejemali 2000 mg in 41,3 % pri bolnikih, ki so prejemali 3000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
English: If you take more Levetiracetam Teva than you should
Slovenian: Če ste vzeli večji odmerek zdravila Levetiracetam Teva, kot bi smeli
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti: pojavijo se pri več kot 1 od 10 oseb
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 50x1 film-coated tablet 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 50x1 filmsko obložena tableta 60 filmsko obloženih tablet 100 flmsko obloženih tablet 120 filmsko obloženih tablet 200 filmsko obloženih tablet
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Slovenian: Odmerki 1800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase zarodka, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Slovenian: Dve študiji embriofetalnega razvoja pri podganah so izvedli z odmerki 400, 1200 in 3600 mg/kg/dan.
English: • flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
Slovenian: • gripi podobne simptome in izpuščaj na obrazu, ki se v nadaljevanju razširi in ga spremlja visoka temperatura, zvišane vrednosti jetrnih encimov pri krvnih testih in povečanje števila določenega tipa belih krvnih celic (eozinofilija) ter povečane bezgavke (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi [DRESS]
English: In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.
Slovenian: Prav tako jakosti tablet, ki so na voljo, niso primerne za doseganje začetnega odmerka pri otrocih, ki so težki do 25 kg, za uporabo pri bolnikih, ki ne morejo pogoltniti tablet ali za dajanje odmerkov nižjih od 250 mg.
English: Other medicines and Levetiracetam Teva
Slovenian: Druga zdravila in zdravilo Levetiacetam Teva
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Slovenian: Ugotovili so, da se levetiracetam pri populaciji po protokolu ne razlikuje (ni manjvredno) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
English: Contents of the pack and other information What Levetiracetam Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Levetiracetam Teva
English: However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Slovenian: Vendar pa podatki nakazujejo, da je pri otrocih, ki jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Slovenian: Zdravnik mora glede na starost, telesno maso in odmerek predpisati najustrežnejšo farmacevtsko obliko, velikost pakiranja in jakost.
English: A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Slovenian: Pri odraslih in otrocih so ugotovili pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij v slini/plazmi se giblje med 1 in 1,7 za tableto za peroralno uporabo in za peroralno raztopino 4 ure po odmerku).
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Slovenian: Levetiracetam in sorodni analogi kažejo vrstni red afinitete za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo protiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
English: • a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Slovenian: • kožni izpuščaj, ki lahko tvori mehurčke in po videzu spominja na majhne tarče (na sredini temne pike, obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem)
English: *The colourants are: 250 mg film-coated tablets: brilliant blue FCF (E133) and indigotine (E132).
Slovenian: *Barvila so: 250 mg filmsko obložene tablete: briljantno modro FCF (E133) in indigotin (E132).
English: • weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
Slovenian: • šibkost, vrtoglavico ali omotico ali težave z dihanjem, saj so to lahko znaki resne alergijske
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/kg twice daily every two weeks).
Slovenian: pri odraslih in mladostnikih, težkih več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri dojenčkih, starejših od 6 mesecev, otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna; pri dojenčkih (mlajših od 6 mesecev): zmanjšanje odmerka ne sme preseči 7 mg/kg dvakrat na dan vsaka dva tedna).
English: • decreased number of blood platelets, decreased number of white blood cells;
Slovenian: • zmanjšano število krvnih ploščic, zmanjšano število belih krvnih celic • zmanjšanje telesne mase, povečanje telesne mase
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Slovenian: Poleg tega je bilo v študijo o varnosti v obdobju po začetku trženja zdravila vključenih 101 dojenčkov, mlajših od 12 mesecev.
English: Transparent PVC/PVdC - aluminium blisters.
Slovenian: Prozorni pretisni omot iz PVC/PVdC-aluminija.