FrancophonIA/ELRC3.0 huggingface dataset:
English: What [Neurontin and associated names] is and what it is used for Before you take [Neurontin and associated names] How to take [Neurontin and associated names] Possible side effects
Slovenian: Kaj je zdravilo [Neurontin in povezana imena] in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo [Neurontin in povezana imena] Kako jemati zdravilo [Neurontin in povezana imena] Možni neželeni učinki
English: • Allergic reaction such as hives
Slovenian: • alergijska reakcija, npr. koprivnica
English: Pfizer Aps Lautrupvang 8 2750 Ballerup Denmark
Slovenian: Pfizer Aps Lautrupvang 8 2750 Ballerup Danska
English: Also supplied as a titration pack for treatment of neuropathic pain containing 40 x 300 mg capsules and 10 x 600 mg tablets.
Slovenian: Za zdravljenje nevropatskih bolečin je na voljo tudi titracijsko pakiranje s 40 x 300 mg kapsulami in 10 x 600 mg tabletami.
English: Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents.
Slovenian: Farmakokinetika gabapentina v stanju dinamičnega ravnovesja je pri zdravih preiskovancih podobna kot pri bolnikih z epilepsijo, ki dobivajo ta antiepileptična zdravila.
English: Gabapentin slightly reduces the release of monoamine neurotransmitters in vitro.
Slovenian: Gabapentin in vitro rahlo zmanjša sproščanje monoaminskih nevrotransmiterjev.
English: Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
Slovenian: Gabapentin smete med nosečnostjo uporabiti le, če možna korist za mater jasno odtehta možno tveganje za plod.
English: Cmax = Maximum steady state plasma concentration tmax = Time for Cmax
Slovenian: Cmax = največja koncentracija v plazmi v stanju dinamičnega ravnovesja tmax = čas do Cmax t1/2 = eliminacijski razpolovni čas
English: In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of corresponding steady-state trough plasma concentrations.
Slovenian: Pri bolnikih z epilepsijo je koncentracija gabapentina v cerebrospinalnem likvorju približno 20 % ustrezne najmanjše plazemske koncentracije v stanju dinamičnega ravnovesja.
English: It is recommended that gabapentin be taken at the earliest two hours following antacid administration.
Slovenian: Gabapentin je priporočljivo vzeti najmanj dve uri po uporabi antacida.
English: In vitro studies with radiolabeled gabapentin have characterized a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant and analgesic activity of gabapentin and its structural derivatives.
Slovenian: Študije in vitro z radioaktivno označenim gabapentinom so pokazale novo peptidno vezavno mesto v tkivu podganjih možganov, vključno z neokorteksom in hipokampusom, ki je morda povezano z antikonvulzivnim in analgetičnim delovanjem gabapentina in njegovih strukturnih izpeljank.
English: Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.
Slovenian: Gabapentin uporabite pri nosečih materah le, če je očitno, da koristi odtehtajo tveganja.
English: • Feeling tired, fever
Slovenian: • občutek utrujenosti, zvišana telesna temperatura
English: False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests.
Slovenian: Pri semikvantitativnem določanju celotnih beljakovin v urinu s testnimi trakovi se lahko pojavijo lažno pozitivni izvidi.
English: How to store [Neurontin and associated names] Further information
Slovenian: Shranjevanje zdravila [Neurontin in povezana imena] Dodatne informacije
English: Gabapentin does not interact with sodium channels in vitro and so differs from phenytoin and carbamazepine.
Slovenian: Gabapentin in vitro ne interagira z natrijevimi kanali in se tako razlikuje od fenitoina in karbamazepina.
English: Slower titration of gabapentin dosage may be appropriate for individual patients.
Slovenian: Za posamezne bolnike utegne biti primerno počasnejše titriranje odmerka gabapentina.
English: The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours.
Slovenian: Njegov eliminacijski razpolovni čas ni odvisen od odmerka in v povprečju znaša od 5 do 7 ur.
English: In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour haemodialysis treatment is recommended.
Slovenian: Poleg vzdrževalnega odmerka je priporočljiv dodaten odmerek od 200 do 300 mg po vsakih 4 urah hemodialize.
English: withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain.
Slovenian: odtegnitvene reakcije (večinoma anksioznost, nespečnost, navzea, bolečine, znojenje), bolečine v prsih.
English: An increased incidence of hydroureter and/or hydronephrosis was observed in rats given 2000 mg/kg/day in a fertility and general reproduction study, 1500 mg/kg/day in a teratology study, and 500, 1000, and 2000 mg/kg/day in a perinatal and postnatal study.
Slovenian: Večjo incidenco hidroureterja in/ali hidronefroze so opažali pri podganah, ki so dobivale 2000 mg/kg/dan v študiji plodnosti in splošne reprodukcije, 1500 mg/kg/dan v študiji teratogenosti ter 500, 1000 in 2000 mg/kg/dan v perinatalni in postnatalni študiji.
English: A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, such as diabetes or shingles.
Slovenian: Periferne nevropatske bolečine (ki se pojavljajo predvsem v nogah in/ali rokah) so lahko posledica najrazličnejših bolezni, npr. diabetesa in pasovca.
English: Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other active substances that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs.
Slovenian: Gabapentin je po zgradbi soroden nevrotransmiterju GABA (gama-aminomaslena kislina), toda njegov mehanizem delovanja se razlikuje od mehanizma pri različnih drugih zdravilnih učinkovinah, ki vplivajo na sinapse GABA, vključno z valproatom, barbiturati, benzodiazepini, zaviralci GABA-transaminaze, zaviralci prevzema GABA, antagonisti GABA in predzdravili GABA.
English: In addition, the MAH confirmed the intention, in a letter of commitment, to submit across EU a paediatric liquid formulation in order to provide a dosage form more suitable for use in children.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom v pismu obveze potrdil namen, da bo po vsej EU predložil otroško tekočo obliko, da bo odmerjanje bolj primerno za otroke.
English: Gabapentin, the active substance of [Neurontin and associated names], is excreted in human milk.
Slovenian: Gabapentin, zdravilna učinkovina v zdravilu [Neurontin in povezana imena], se izloča v materino mleko.
English: • Decreased platelets (blood clotting cells)
Slovenian: • zmanjšano število trombocitov (krvnih ploščic, potrebnih za strjevanje krvi)
English: [Neurontin and associated names] should not be taken during pregnancy, unless you are told otherwise by your doctor.
Slovenian: Zdravila [Neurontin in povezana imena] ne smete jemati med nosečnostjo, razen če vam tako naroči zdravnik.
English: Because the effect on the breast-fed infant is unknown, caution should be exercised when gabapentin is administered to a breast-feeding mother.
Slovenian: Učinek na dojenega otroka ni znan, zato je treba gabapentin pri doječih materah uporabljati previdno.
English: 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] Capsules: 20, 30, 50, 84, 90, 98, 100, 200, 500, 1000 Tablets: 20, 30, 45, 50, 84, 90, 100, 200, 500
Slovenian: Kapsule: 20, 30, 50, 84, 90, 98, 100, 200, 500, 1000
English: • High blood pressure, flushing or dilation of blood vessels
Slovenian: • visok krvni tlak, zardevanje ali razširitev žil
English: In general, plasma gabapentin concentrations in children > 5 years of age are similar to those in adults when dosed on a mg/kg basis.
Slovenian: Na splošno je bila koncentracija gabapentina v plazmi ob odmerjanju na podlagi mg/kg pri otrocih, starejših od 5 let, podobna kot pri odraslih.
English: The risk of birth defects is increased by a factor of 2 - 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Slovenian: Tveganje za prirojene hibe je pri otrocih mater, ki dobivajo kakšno antiepileptično zdravilo, 2- do 3-krat večje.
English: − The active substance is gabapentin.
Slovenian: − Zdravilna učinkovina je gabapentin.
English: Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABAA, GABAB, benzodiazepine, glutamate, glycine or N-methyl-daspartate receptors.
Slovenian: Gabapentin se v klinično pomembnih koncentracijah ne veže na druge pogoste možganske receptorje za zdravila ali nevrotransmiterje, vključno z receptorji za GABAA, GABAB, benzodiazepine, glutamat, glicin ali N-metil-d-aspartat.
English: incontinence
Slovenian: inkontinenca
English: • Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking
Slovenian: • jeza do drugih, zmedenost, nihanje razpoloženja, depresija, tesnobnost, živčnost, težave z razmišljanjem
English: Pfizer Corporation Austria Gesellschaft m.b.H Floridsdorfer Hauptstraße 1 1210 Wien, Austria
Slovenian: Pfizer Corporation Austria Gesellschaft m.b.H Floridsdorfer Hauptstraße 1 1210 Wien, Avstrija
English: Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day.
Slovenian: Potem je mogoče odmerek glede na bolnikov odziv in prenašanje povečevati po 300 mg/dan na 2 do 3 dni do največjega odmerka 3600 mg/dan.
English: [Neurontin and associated names] is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
Slovenian: Ni pričakovati, da bi imelo zdravilo [Neurontin in povezana imena] medsebojne učinke z drugimi zdravili za zdravljenje epilepsije ali s peroralnimi kontracepcijskimi tabletami.
English: The MAH confirmed the intention, in a letter of commitment, to submit across EU a paediatric liquid formulation in order to provide a dosage form more suitable for use in children.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v pismu obveze potrdil namen, da bo po vsej EU predložil otroško tekočo obliko, da bo odmerjanje bolj primerno za otroke.
English: In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months.
Slovenian: Učinkovitost in varnost pri zdravljenju perifernih nevropatskih bolečin, npr. boleče diabetične nevropatije in poherpetične nevralgije, v kliničnih študijah nista bili raziskani v terapevtskem obdobju, daljšem od 5 mesecev.
English: Table 3 Summary of gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours administration
Slovenian: Povzetek povprečnih (% KV) farmakokinetičnih parametrov gabapentina v stanju dinamičnega ravnovesja po uporabi na 8 ur farmakokinetični parameter
English: Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms.
Slovenian: Gabapentin deluje na osrednje živčevje in lahko povzroči zaspanost, omotico in druge sorodne simptome.
English: • Inflammation of the liver, yellowing of the skin and eyes
Slovenian: • vnetje jeter, porumenelost kože in oči
English: hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Slovenian: hostilnost, zmedenost in čustvena labilnost, depresija, anksioznost, živčnost, nenormalno mišljenje
English: Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years.
Slovenian: Gabapentin so dve leti dajali mišim v odmerkih 200, 600 in 2000 mg/kg/dan in podganam v odmerkih 250, 1000 in 2000 mg/kg/dan.
English: − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: − Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: acute renal failure
Slovenian: akutna odpoved ledvic
English: 300 mg once a day
Slovenian: 300 mg trikrat na dan
English: Floridsdorfer Haupstraße 1 1210 Wien, Austria
Slovenian: Floridsdorfer Haupstraße 1 1210 Wien, Avstrija
English: • Low white blood cell counts
Slovenian: • zmanjšanje števila belih krvnih celic
English: Use in patients undergoing haemodialysis
Slovenian: Uporaba pri bolnikih na hemodializi
English: No effects were observed in pregnant mice given 500 mg/kg/day (approximately 1/2 of the daily human dose on a mg/m2 basis).
Slovenian: Nobenih učinkov niso opazili pri brejih miših, ki so dobivale 500 mg/kg/dan (kar je približno 1/2 dnevnega odmerka na podlagi mg/m2).
English: Cardiac disorders Rare:
Slovenian: Srčne bolezni Redki:
English: Floridsdorfer Hauptstraße 1 1210 Wien, Austria
Slovenian: Floridsdorfer Hauptstraße 1 1210 Wien, Avstrija
English: Continue taking [Neurontin and associated names] until your doctor tells you to stop.
Slovenian: Zdravilo [Neurontin in povezana imena] jemljite, dokler vam zdravnik ne naroči, da nehajte.
English: These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during organogenesis and in rats given 500, 1000, or 2000 mg/kg prior to and during mating and throughout gestation.
Slovenian: Ti učinki so se pojavili, ko so breje miši dobivale peroralne odmerke 1000 ali 3000 mg/kg/dan med organogenezo oz. podgane 500, 1000 ali 2000 mg/kg pred parjenjem in med njim ter v času gestacije.
English: Furthermore, attempts to withdraw concomitant anti-epileptics in treatment refractory patients on more than one anti-epileptic, in order to reach gabapentin monotherapy is not recommended as a low success rate is expected, as with other anti-epileptics.
Slovenian: Poleg tega poskusi odtegnitve sočasno uporabljanih antiepileptikov za zdravljenje neodzivnih bolnikov na več antiepileptikih zaradi uvedbe monoterapije z gabapentinom niso priporočljivi zaradi pričakovane nizke stopnje uspešnosti; podobno kot pri drugih antiepileptikih.
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Slovenian: Najpogosteje opisane so heiloshiza, srčnožilne malformacije in defekti nevralne cevi.
English: Therefore, the MAH proposal of a harmonised wording was endorsed; as follows: “Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.”
Slovenian: Zato je bil predlog imetnika dovoljenja za promet z zdravilom (MAH) glede usklajenega besedila potrjen v naslednji obliki: „Gabapentin je indiciran za zdravljenje periferne nevropatske bolečine, npr. boleče diabetične nevropatije in postherpetične nevralgije pri odraslih.“
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN RAZLOGI ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Gabapentin administration to rats increases GABA turnover in several brain regions in a manner similar to valproate sodium, although in different regions of brain.
Slovenian: Aplikacija gabapentina pri podganah v več možganskih predelih podobno kot natrijev valproat poveča obrat GABA, vendar v drugih predelih možganov.
English: Gabapentin is present in the breast milk of breast-feeding women.
Slovenian: Gabapentin se izloča v mleko doječih žensk.
English: Steady state plasma gabapentin concentrations are predictable from single-dose data.
Slovenian: Koncentracija gabapentina v stanju dinamičnega ravnovesja je predvidljiva iz podatkov o enkratnem odmerku.
English: Therefore, the following indication was agreed by the CHMP: “Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.” The posology is to be adjusted individually depending on response and tolerability.
Slovenian: Zato CHMP soglaša z naslednjo indikacijo: „Gabapentin je indiciran kot monoterapija pri odraslih in mladostnikih, starih 12 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje.“ Odmerjanje je potrebno prilagoditi posamezniku glede na odziv in prenašanje.
English: Rare side-effects which may affect less than 1 person in 1000 are listed below:
Slovenian: Spodaj so našteti redki neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 1000 oseb:
English: Boulevard de la Plaine, 17 B-1050 Bruxelles Belgium
Slovenian: Boulevard de la Plaine, 17 B-1050 Bruxelles Belgija
English: Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.
Slovenian: Gabapentin ni ne in vitro ne in vivo izzval strukturnih kromosomskih aberacij v celicah sesalcev in ni izzval nastajanja mikrojeder v kostnem mozgu hrčkov.
English: Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Slovenian: Začetni odmerek navadno znaša med 300 mg in 900 mg na dan. Potem je mogoče odmerek postopoma povečati do največ 3600 mg na dan in vaš zdravnik vam bo naročil, da zdravilo jemljite v treh deljenih odmerkih, tj. enkrat zjutraj, enkrat popoldne in enkrat zvečer.
English: DOSING CHART - INITIAL TITRATION
Slovenian: PREGLEDNICA ODMERJANJA - UVODNO TITRIRANJE 1. dan
English: No interaction between gabapentin and phenobarbital, phenytoin, valproic acid, or carbamazepine has been observed.
Slovenian: Med gabapentinom in fenobarbitalom, fenitoinom, valproinsko kislino ali karbamazepinom niso ugotovili medsebojnega delovanja.
English: convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Slovenian: konvulzije, hiperkinezije, dizartrija, amnezija, tremor, nespečnost, glavobol, zaznave kot so parestezije ali hipestezija, nenormalna koordinacija, nistagmus, okrepljeni, oslabljeni ali odsotni refleksi
English: • Problems with abnormal movements such as writhing, jerking movements and stiffness
Slovenian: • težave zaradi nenormalnih gibov, npr. zvijanje, trzanje in otrplost
English: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia Musculoskeletal, connective tissue and bone disorders Common:
Slovenian: Stevens-Johnsonov sindrom, angioedem, multiformni eritem, alopecija
English: On dialysis-free days, there should be no treatment with gabapentin.
Slovenian: Ob dneh brez dialize bolniki ne smejo dobiti gabapentina.
English: 4.1 Therapeutic indications
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije Epilepsija
English: • Feeling drowsy, dizziness, lack of coordination
Slovenian: • občutek zaspanosti, omotica, nekoordiniranost gibov
English: Film-coated tablets
Slovenian: Filmsko obložene tablete
English: hallucinations
Slovenian: halucinacije
English: “Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).” An update of efficacy data in children has been made in section 5.1.
Slovenian: „Gabapentin je indiciran kot dodatno zdravljenje pri odraslih in otrocih, starih 6 let in več, ki imajo parcialne napade s sekundarno generalizacijo ali brez nje (glejte poglavje 5.1).“ V poglavju 5.1 so posodobljeni podatki o učinkovitosti pri otrocih.
English: Peak plasma drug concentrations in rats at 2000 mg/kg/day are 10 times higher than plasma concentrations in humans given 3600 mg/day.
Slovenian: Ob odmerku 2000 mg/kg/dan je največja plazemska koncentracija zdravila pri podganah 10-krat večja kot plazemska koncentracija pri ljudeh, ki dobivajo 3600 mg/dan.
English: The most common undesirable effects observed in clinical trials consisted of somnolence, dizziness, ataxia, fatigue, fever and viral infection.
Slovenian: Najpogostejši neželeni učinki med kliničnimi raziskavami so bili somnolenca, omotica, ataksija, utrujenost, zvišana telesna temperatura in virusna okužba.
English: Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.
Slovenian: Zato naj bi med nosečnostjo, če je to mogoče, jemali le eno zdravilo za zdravljenje epilepsije, vendar le po nasvetu zdravnika.
English: • Difficulty breathing, bronchitis, sore throat, cough, dry nose
Slovenian: • težko dihanje, bronhitis, bolečine v grlu, kašelj, suhost nosu
English: Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
Slovenian: Gabapentin je indiciran za zdravljenje periferne nevropatske bolečine, npr. boleče diabetične nevropatije in postherpetične nevralgije pri odraslih.
English: Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Slovenian: Poleg tega so v kliničnih študijah pri otrocih pogosto poročali o agresivnem vedenju in hiperkinezijah.
English: Gabapentin induced delayed ossification in the skull, vertebrae, forelimbs, and hindlimbs in rodents, indicative of fetal growth retardation.
Slovenian: Gabapentin pri glodalcih upočasni osifikacijo lobanje, vretenc ter sprednjih in zadnjih udov, kar nakazuje upočasnjeno rast ploda.
English: However, several amendments to the SPC were introduced.
Slovenian: Kljub temu je Povzetek glavnih značilnosti zdravila (SPC) večkrat dopolnjen.
English: A statistically significant increase in the incidence of pancreatic acinar cell tumors was found only in male rats at the highest dose.
Slovenian: Ob največjem odmerku so le pri podganjih samcih ugotovili statistično značilno povečanje incidence tumorjev pankreatičnih acinarnih celic.
English: Adults
Slovenian: Odrasli:
English: It was not mutagenic in vitro in standard assays using bacterial or mammalian cells.
Slovenian: V standardnih preizkusih in vitro z uporabo bakterijskih celic in celic sesalcev ni bil mutagen.
English: No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Developmental delay in children of mothers with epilepsy has been observed rarely.
Slovenian: Antiepileptične terapije ne smete prekiniti nenadoma, ker to lahko povzroči občasna poslabšanja napadov, ki imajo lahko resne posledice za mater in otroka.
English: Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).
Slovenian: Pri bolnikih z okrnjenim delovanjem ledvic in bolnikih na hemodializi je priporočljiva prilagoditev odmerka (glejte poglavje 4.2).
English: • Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear
Slovenian: • pljučnica, okužba dihal, okužba sečil, okužba, vnetje ušesa
English: movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Slovenian: motnje gibanja (npr. horeoatetoza, diskinezija, distonija)
English: • Efficacy issues
Slovenian: • Vprašanja učinkovitosti
English: • Decrease in white blood cells, increase in weight
Slovenian: • zmanjšanje števila belih krvnih celic, zmanjšanje telesne mase