natgillin/translations-raw huggingface dataset:
progesterone, estradiol), testosterone; - glucocorticoids (hydrocortisone, dexamethasone); - omeprazole (used to treat diseases related to gastric acid production); - paracetamol (used to treat pain and fever); - theophylline (used to improve bronchial air flow); - nefazodone (used to treat depression); - aprepitant (used to treat nausea); - some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.
estradiol, testosteron), - glukokortikoidi (kot sta hidrokortizon, deksametazon), - omeprazol (uporablja se za zdravljenje bolezni, povezanih z nastajanjem želodčne kisline), - paracetamol (uporablja se za lajšanje bolečine in zbijanje visoke telesne temperature), - dekstrometorfan (uporablja se za zdravljenje kašlja), - teofilin (uporablja se za izboljšanje pretoka zraka v bronhijih), - nefazodon (uporablja se za zdravljenje depresije), - aprepitant (uporablja se za zdravljenje slabosti), - nekateri plini (kot so enfluran, halotan in izofluran), ki se uporabljajo za splošno anestezijo.
Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), poor appetite or loss of appetite, eye infection, heart rhythm disturbances (change as in adults, ECG changes), abdominal pain, vomiting, diarrhoea, skin inflammation, rash, general weakness.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužba dihal, okužba ušesa, anemija, nenormalnosti različnih vrst krvnih celic (bele krvne celice ali trombociti), slab apetit ali izguba apetita, okužba očesa, motnje srčnega ritma (spremembe kot pri odraslih, spremembe na EKG), bolečina v trebuhu, bruhanje, driska, vnetje kože, izpuščaj, splošna oslabelost.
Hepatomegaly Abnormal liver function tests
Bolezni jeter, žolčnika in žolčevodov hepatitis hepatomegalija nenormalni izvidi testov delovanja jeter
− If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Influenza, respiratory infections, poor appetite or loss of appetite, dizziness, convulsions (fits), irregular or slow heart rate, cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, abnormal liver function tests, itching, pain in the muscles or joints.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): gripa, okužbe dihal, slab apetit ali izguba apetita, omotičnost, konvulzije (napadi), nepravilen ali počasen srčni utrip, kašelj, bruhanje, bolečina v trebuhu, driska, navzea, vnetje ali povečanje jeter, nenormalni testi delovanja jeter, srbenje, bolečina v mišicah ali sklepih.
QT/QTc prolonged Heart rate irregular
Srčne bolezni podaljšanje QT/QTc nepravilen srčni utrip motnje srčne prevodnosti šum na srcu
A tabular overview of the frequency of the ADRs in paediatric patients is given below.
Pregled neželenih učinkov za pediatrične bolnike v obliki tabele je naveden spodaj.
Consequently, if Eurartesim is more suitable for a pregnant woman than other artemisinin-based combination therapies with a higher range of experience (or sulfadoxine-pyrimethamine), Eurartesim may be used in the 2nd and 3 trimester.
Zato se zdravilo Eurartesim sme uporabljati v 2. in 3. trimesečju nosečnosti, če je za nosečnico primernejše od drugih kombiniranih zdravljenj na osnovi artemizinina (ali sulfadoksina/pirimetamina), s katerimi je več izkušenj.
Eurartesim 160 mg/20 mg film-coated tablets.
IME ZDRAVILA Eurartesim 160 mg/20 mg filmsko obložene tablete
Always take Eurartesim exactly as your doctor has told you to.
Pri jemanju zdravila Eurartesim natančno upoštevajte navodila zdravnika.
2 x 320 mg / 40 mg tablets
2 x 320 mg / 40 mg tableti
nitrendipine, verapamil, felodipine, amlodipine); - some medicines used to treat HIV (antiretroviral medicinese): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); - some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); - medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,
nifedipin, nitrendipin, verapamil, felodipin, amlodipin), - nekatera zdravila za zdravljenje okužbe z virusom HIV (antiretrovirusna zdravila): zaviralci proteaze (kot so amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), nenukleozidni zaviralci reverzne transkriptaze (kot so efavirenz, nevirapin), - nekatera zdravila, ki se uporabljajo za zdravljenje mikrobnih okužb (kot so telitromicin,
If Eurartesim is more suitable for a pregnant woman than other artemisinin-based combination therapies with a higher range of experience (or sulfadoxine-pyrimethamine), Eurartesim may be used in the 2nd and 3rd trimester.
Zdravilo Eurartesim se sme uporabljati v 2. in 3. trimesečju nosečnosti, če je za nosečnico primernejše od drugih kombiniranih zdravljenj na osnovi artemizinina (ali sulfadoksina/pirimetamina), s katerimi je več izkušenj.
How to store Eurartesim
Shranjevanje zdravila Eurartesim
Infections and infestations
Infekcijske in parazitske bolezni okužba s
Eurartesim 320 mg/40 mg film-coated tablets.
IME ZDRAVILA Eurartesim 320 mg/40 mg filmsko obložene tablete
Pruritis
Dojenje
nitrendipine, verapamil, felodipine, amlodipine); - some medicines used to treat HIV (antiretroviral medicines): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); - some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); - medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,
Primeri so našteti spodaj (vendar obstaja še veliko drugih): - nekatera zdravila za zdravljenje visokega holesterola v krvi (kot so atorvastatin, cerivastatin, lovastatin, simvastatin), - zdravila, ki se uporabljajo za zdravljenje hipertenzije in težav s srcem (kot so diltiazem, nifedipin, nitrendipin, verapamil, felodipin, amlodipin), - nekatera zdravila za zdravljenje okužbe z virusom HIV (antiretrovirusna zdravila): zaviralci proteaze (kot so amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), nenukleozidni zaviralci reverzne transkriptaze (kot so efavirenz, nevirapin), - nekatera zdravila, ki se uporabljajo za zdravljenje mikrobnih okužb (kot so telitromicin, rifampicin, dapson), - zdravila, ki vam pomagajo zaspati: benzodiazepini (kot so midazolam, triazolam, diazepam, alprazolam, zaleplon, zolpidem),
What you need to know before you or your child takes Eurartesim Do not take Eurartesim if you or your child:
Kaj morate vedeti, preden boste vi ali vaš otrok vzeli zdravilo Eurartesim
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba
Thrombocythaemia Splenomegaly Lymphadenopathy Hypochromasia
Bolezni krvi in limfatičnega sistema trombocitopenija levkopenija/nevtrope nija nespecificirane levkocitoze anemija trombocitemija splenomegalija limfadenopatija hipokromazija
Vomiting Diarrhoea Nausea
Očesne bolezni konjunktivitis
− imidazole and triazole antifungal medicinal products,
− antimikotika imidazol in triazol
Vomiting Diarrhoea Abdominal pain
Bolezni prebavil bruhanje driska navzea bolečina v trebuhu
Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate) and 40 mg artenimol.
Ena filmsko obložena tableta vsebuje 320 mg piperakin tetrafosfata (v obliki tetrahidrata) in 40 mg artenimola.
Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate) and 20 mg artenimol.
Ena filmsko obložena tableta vsebuje 160 mg piperakin tetrafosfata (v obliki tetrahidrata) in 20 mg artenimola.
Eurartesim 160 mg/20 mg tablets piperaquine tetraphosphate/artenimol
Eurartesim 160 mg/20 mg tablete piperakin tetrafosfat/artenimol
Concomitant Medication checklist
KLINIČNI PODATKI
36 to less than 75 Three 320 mg/40 mg tablets a day
9 tablet več kot 75 Štiri 320 mg/40 mg tablete na dan
Respiratory tract infection Influenza
Infekcijske in parazitske bolezni gripa okužba s
Eurartesim 320 mg/40 mg film-coated tablets piperaquine tetraphosphate / artenimol
Eurartesim 320 mg/40 mg filmsko obložene tablete piperakin tetrafosfat/artenimol
Acanthosis Pruritis
artezunatom.
Eurartesim 160 mg/20 mg film-coated tablets piperaquine tetraphosphate/artenimol
Eurartesim 160 mg/20 mg filmsko obložene tablete piperakin tetrafosfat/artenimol
Four 320 mg/40 mg tablets a day
Ena 320 mg/40 mg tableta na dan
Metabolism and nutrition disorders
Presnovne in prehranske motnje anoreksija
Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α- artenimol-G with no cytochrome P450-mediated metabolism.
Študije na mikrosomih človeških jeter so pokazale, da je artenimol presnavljala UDP-glukuronosiltransferaza (UGT1A9 in
9 tablets Film-coated tablets.
filmsko obložene tablete - 3 tablete filmsko obložene tablete - 6 tablet filmsko obložene tablete - 9 tablet filmsko obložene tablete - 12 tablet
Stomatitis Nausea
PRETISNI OMOT
quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine or sotalol; medicines used to treat depression such as amitriptyline, fluoxetine or sertraline; medicines used to treat mental health problems such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine; medicines used to treat infections.
zdravila, ki se uporabljajo duševnih težav, kot so fenotiazini, sertindol, sultoprid, klorpromazin, haloperidol, mezoridazin, pimozid ali tioridazin; zdravila, ki se uporabljajo za zdravljenje okužb.
Eurartesim 320 mg/40 mg tablets piperaquine tetraphosphate / artenimol
IME ZDRAVILA Eurartesim 320 mg/40 mg tablete piperakin tetrafosfat/artenimol
Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 160 mg piperakin tetrafosfata (v obliki tetrahidrata; PKP) in 20 mg artenimola.
Respiratory tract infection Ear infection
P. falciparum okužba dihal okužba ušesa
Talk to your doctor or pharmacist before taking this medicine if you or your child:
Pred začetkom jemanja zdravila Eurartesim se posvetujte z zdravnikom ali farmacevtom, če:
Contents of the pack and other information What Eurartesim contains
Kaj vsebuje zdravilo Eurartesim
Thrombocytopenia Leukopenia/neutrope nia
Okvarjeno delovanje jeter in ledvic
Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 320 mg piperakin tetrafosfata (v obliki tetrahidrata; PKP) in 40 mg artenimola.
EU/2/11/127/001 Recuvyra 50 mg/ml Transdermal
EU/2/11/127/001 Recuvyra 50 mg/ml transdermalna transdermalna viala (steklena)
1 vial + 1 adapter + 15 syringes + 15 applicator tips
1 viala + 1 adapter + 15 brizg + 15 aplikacijskih nastavkov
Packaging Content Package size Withdrawal period
Ovojnina Vsebina Velikost pakiranja Karenca
Date of first authorisation: 26 August 2011 Date of latest renewal: 15 July 2016
Datum prve odobritve: 26. avgust 2011 Datum zadnjega podaljšanja: 15. julij 2016
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr je prilagojen na telesno površino (BSA- »body surface area«) na sledeč način:
Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Levetiracetam Teva morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
You may take Levetiracetam Teva with or without food.
Levetiracetam Teva lahko vzamete s hrano ali brez nje.
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
*Prevalenca je bistveno višja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki
This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60% glede na običajno koncentracijo pred nosečnostjo).
• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
• če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Ne smete voziti ali upravljati stroev, dokler ni potrjeno, da ni vpliva na vašo sposobnost izvajanja teh dejavnosti.
No data on the interaction of levetiracetam with alcohol are available.
Podatkov o interakciji levetiracetama z alkoholom ni na voljo.
There was no effect on embryomortality and no increased incidence of malformations.
Vpliva na umrljivost zarodkov in povečanja pojava malformacij ni bilo.
< 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
< 1/100); redki: (≥ 1/10.000 do < 1/1.000) in zelo redki: (< 1/10.000).
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.
Ne jemljite makrogola (zdravilo, ki se uporablja kot laksativ) eno uro pred in eno uro po jemanju levetiracetama, ker lahko zmanjša učinek levetiracetama.
Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Zaradi tega se makrogola ne sme jemati peroralno eno uro pred in eno uro po jemanju levetiracetama.
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Preden začnete zdravilo jemati vi ali vaš otrok, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
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).
Eden nastane s hidroksilacijo pirolidonskega obroča (1,6 % odmerka), drugi z odprtjem pirolidonskega obroča (0,9 % odmerka).
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilnega razmišljanja ali vedenja.
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).
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).
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet that is to say essentially `sodium-free ´.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obloženo tableto, kar v bistvu pomeni ‘brez natrija'.
Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
• a more severe form of rash causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis)
• hujšo obliko izpuščaja, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza)
• If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti se posvetujte z zdravnikom.
This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Ta učinek je bil izrazit pri mlajših dojenčkih, z naraščanjem starosti je upadal in postal zanemarljiv okoli
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
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
However, if levetiracetam treatment is needed during breast-feeding, the benefit/risk of the treatment should be weighed considering the importance of breast-feeding.
Če je zdravljenje z levetiracetamom v obdobju dojenja potrebno, se mora pretehtati razmerje med koristjo in tveganjem zdravljenja glede na pomembnost dojenja.
You should continue Levetiracetam Teva treatment for as long as your doctor has told you.
Levetiracetam Teva morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Učinkovitost dializne ekstrakcije levetiracetama je 60 %, primarnega presnovka pa 74 %.
What you need to know before you take Levetiracetam Teva Do not take Levetiracetam Teva
Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Teva Ne jemljite zdravila Levetiracetam Teva
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
ks = 0,45 pri dojenčkih do 1 leta starosti; ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah;
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.
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.
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.
• Dose in adults and adolescents (from 16 years of age):
• Odmerjanje pri odraslih in mladostnikih (od 16 leta starosti:)
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK United Kingdom
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK Velika Britanija
At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kot na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
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).
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).
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.
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.
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).
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).
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
Kaj je zdravilo Levetiracetam Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Teva Kako jemati zdravilo Levetiracetam Teva
• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
• za samostojno zdravljenje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
Levetiracetam Teva contains Sodium
Levetiracetam Teva vsebuje natrij
The daily dose must be individualised according to renal function.
Dnevni odmerek je treba prilagoditi individualno glede na delovanje ledvic.
Swallow Levetiracetam Teva tablets with a sufficient quantity of liquid (e.g. a glass of water).
Način uporabe Tablete zdravila Levetiracetam Teva zaužijte z dovolj tekočine (npr. s kozarcem vode).
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
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
What Levetiracetam Teva is and what it is used for
Kaj je zdravilo Levetiracetam Teva in za kaj ga uporabljamo
Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Največjo koncentracijo v plazmi (Cmax) dosežemo 1,3 ure po odmerku.
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.
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.
The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Varnost in učinkovitost levetiracetama pri otrocih in mladostnikih, mlajših od 16 let, pri samostojnem zdravljenju nista bili dokazani.
• 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
• 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
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.
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.