FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Slovenian: Redki povečanje koncentracije glukoze v krvi, podaljšan aktiviran delni tromboplastinski čas, zmanjšano število rdečih krvnih celic, zvišanje ravni alkalne fosfataze v krvi, povečane vrednosti kreatin fosfokinaze v krvi* * Neželeni učinki iz obdobja trženja.
English: How to store ADENURIC
Slovenian: Shranjevanje zdravila ADENURIC
English: • reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
Slovenian: • Rdečina kože (eritem), različni tipi izpuščajev (npr. srbeč, z belimi pikami, z mehurčki, z gnojnimi mehurčki, z luščenjem kože, noricam podoben izpuščaj), razširjena rdečina kože,
English: ADENURIC showed a superior and faster urate lowering activity compared to allopurinol.
Slovenian: V primerjavi z alopurinolom je zdravilo ADENURIC imelo boljši in hitrejši učinek na zmanjšanje sečne kisline.
English: ADENURIC 120 mg film-coated tablets Febuxostat
Slovenian: ADENURIC 120 mg filmsko obložene tablete febuksostat
English: ADENURIC 80 mg film-coated tablets Febuxostat
Slovenian: ADENURIC 80 mg filmsko obložene tablete febuksostat
English: Modelling and simulation analysis of data from a pre-clinical study in rats indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Slovenian: Modeliranje in simulacija analiznih podatkov predklinične študije, izvedene na podganah, v primeru sočasnega jemanja s febuksostatom kažejo, da je potrebno odmerek merkaptopurina/azatioprina zmanjšati na 20 % ali manj prvotno predpisanega odmerka (glejte poglavji 4.4 in 5.3).
English: Talk to your doctor before taking ADENURIC:
Slovenian: Pred začetkom jemanja zdravila ADENURIC se posvetujte s svojim zdravnikom ali s farmacevtom:
English: Tablet core
Slovenian: Obloga tablete
English: Diarrhoea**, nausea
Slovenian: Pogosti driska**, navzea
English: ADENURIC 80 mg tablets Febuxostat
Slovenian: IME ZDRAVILA ADENURIC 80 mg tablete febuksostat
English: ADENURIC 120 mg tablets Febuxostat
Slovenian: IME ZDRAVILA ADENURIC 120 mg tablete febuksostat
English: FACT study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups.
Slovenian: Študija FACT: V času 8 tedenskega preventivnega zdravljenja je večji delež oseb zdravljenih s febuksostat 120 mg (36 %) potreboval zdravljenje zaradi izbruha protina v kot v skupinah zdravljenih s febuksostatom 80 mg (22 %) in alopurinol 300 mg (21 %).
English: APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%).
Slovenian: Klinični izidi: Delež bolnikov, pri katerih je bilo treba zdraviti izbruh protina Študija APEX: V času 8 tedenskega preventivnega zdravljenja je večji delež oseb potreboval zdravljenje zagona putike v skupini s 120 mg febuksostata (36 %), kot v skupini s febuksostatom 80 mg (28 %), alopurinolom 300 mg (23 %) in placebo (20 %) skupinah.
English: Nervousness
Slovenian: Bolezni živčevja
English: Opadry II, Yellow, 85F42129 containing: Polyvinyl alcohol
Slovenian: Opadry II rumena 85F42129, ki vsebuje: polivinil alkohol titanov dioksid (E171) makrogol 3350 smukec rumeni železov oksid (E172)
English: ADENURIC achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups.
Slovenian: Pri bolnikih z okvaro ledvic, ki so bili naključno razporejeni v skupino, ki je prejemala alopurinol, je bila višina odmerka omejena na 100 mg enkrat na dan. Primarni opazovani dogodek učinkovitosti je bil v skupini, ki je jemala zdravilo ADENURIC, dosežen pri 44 % (80 mg enkrat na dan), 45 % (120 mg enkrat na dan) in 60 % (240 mg enkrat na dan) bolnikov v primerjavi z 0 % v skupinah, ki so prejemale alopurinol 100 mg enkrat na dan ali placebo.
English: Each tablet contains 80 mg of febuxostat.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg febuksostata.
English: Rare Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness
Slovenian: Redki toksična epidermalna nekroliza*, Stevens-Johnsonov sindrom*,
English: Each tablet contains 120 mg of febuxostat.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 120 mg febuksostata.
English: ADENURIC 120 mg film-coated tablets
Slovenian: IME ZDRAVILA ADENURIC 120 mg filmsko obložene tablete
English: ADENURIC 80 mg film-coated tablets
Slovenian: IME ZDRAVILA ADENURIC 80 mg filmsko obložene tablete
English: Oedema
Slovenian: Protin
English: Gout flares
Slovenian: Patheon France
English: Package leaflet: Information for the user ADENURIC 80 mg film-coated tablets ADENURIC 120 mg film-coated tablets
Slovenian: ADENURIC 80 mg filmsko obložene tablete ADENURIC 120 mg filmsko obložene tablete febuksostat
English: Liver function abnormalities** Uncommon
Slovenian: Pogosti nenormalni rezultati jetrne funkcije** Občasni holelitiaza
English: − if you are less than 18 years of age.
Slovenian: − če ste mlajši od 18 let.
English: There are no adequate or well-controlled studies in pregnant women.
Slovenian: Ni zadostnih ali dobro kontroliranih študij pri nosečnicah.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19 June 2006
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 19 junij 2006
English: Effect of food:
Slovenian: Vpliv hrane:
English: Most of the observed weight reduction was obtained within the first nine months of treatment.
Slovenian: Večina opaženega zmanjšanja telesne mase je bila dosežena v prvih devetih mesecih zdravljenja.
English: Use in pregnancy is, therefore, not recommended.
Slovenian: Uporaba med nosečnostjo zato ni priporočljiva.
English: Elderly patients have slightly higher exposure than young patients.
Slovenian: Izpostavljenost starejših bolnikov je rahlo večja kot izpostavljenost mladih bolnikov.
English: An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
Slovenian: Obnovljen načrt upravljanja tveganja mora biti izdelan kot so CHMP smernice za sistem upravljanja tveganja za zdravila za humano uporabo.
English: WHAT ACOMPLIA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO ACOMPLIA IN ZA KAJ GA UPORABLJAMO
English: The patient should be monitored and treated appropriately.
Slovenian: Bolnik mora biti primerno nadzorovan in zdravljen.
English: Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Slovenian: Približno 80 % populacije so bile ženske, 87 % je bilo belcev in 9% črncev.
English: Obesity is a condition that can be associated with depressive disorders.
Slovenian: Debelost je stanje, ki je lahko povezano z depresivnimi motnjami.
English: Table 2:
Slovenian: Tabela 2:
English: The potential relevance of this to administration of a CB1 antagonist is unknown.
Slovenian: Potencialni pomen tega za uporabo antagonista CB1 ni znan.
English: Patients should be instructed not to increase their dose of ACOMPLIA.
Slovenian: Bolnikom morate naročiti, naj ne povečujejo odmerka zdravila ACOMPLIA.
English: In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies.
Slovenian: Skupaj je bilo v klinične študije 2. in 3. faze vključenih več kot 6800 bolnikov.
English: − if you have previously suffered from depression or have had suicidal thoughts
Slovenian: − če ste kdaj imeli depresijo ali ste razmišljali o samomoru,
English: INFORMATION IN BRAILLE ACOMPLIA
Slovenian: PODATKI V BRAILLOVI PISAVI ACOMPLIA
English: Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.
Slovenian: Zdravnik vam bo svetoval potrebno dieto in raven telesne dejavnosti, ki bosta ustrezali vašemu stanju in splošnemu zdravju.
English: There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose.
Slovenian: Specifičnega antidota za rimonabant ni, zato je treba v primeru prevelikega odmerjanja uvesti ustrezne podporne ukrepe.
English: A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Slovenian: Prokonvulzivno delovanje rimonabanta so ugotovili v eni od dveh študij farmakološke varnosti.
English: Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Slovenian: Bolniki črnci imajo lahko do 31 % manjšo Cmax in 43 % manjšo AUC kot bolniki drugih ras.
English: Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Slovenian: Depresivne motnje so lahko povezane z večjim tveganjem za samomorilne misli, samopoškodovanje in samomor.
English: In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals.
Slovenian: V nekaterih primerih - ne pa v vseh - je bila sprožitev konvulzij po vsem sodeč povezana s stresom zaradi postopka, npr. rokovanja z živalmi.
English: − if you have diabetes (see section 4)
Slovenian: − če imate sladkorno bolezen (glejte poglavje 4),
English: The pharmacokinetic profile demonstrates that a plateau in exposures is reached at 180 mg.
Slovenian: Farmakokinetični profil kaže, da je plato izpostavljenosti dosežen s 180 mg.
English: Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Slovenian: Depresivno razpoloženje se lahko razvije pri bolnikih, ki nimajo očitnih dejavnikov tveganja, razen debelosti same.
English: 5 How to store ACOMPLIA Further information
Slovenian: 5 Shranjevanje zdravila ACOMPLIA Dodatne informacije
English: Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Slovenian: Omejeni podatki kažejo na večjo izpostavljenost pri bolnikih z zmerno okvaro ledvic (40% povečanje AUC).
English: The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and they were advised to increase their physical activity.
Slovenian: Bolniki v preskušanjih 3. faze so med preskušanji uživali restriktivno dieto, ki jo je predpisal dietetik, in svetovali so jim , naj povečajo svojo telesno dejavnost.
English: Important information about some of the ingredients of ACOMPLIA ACOMPLIA tablets include lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila ACOMPLIA Tablete ACOMPLIA vsebujejo laktozo.
English: In postmarketing experience, more than half of the patients who develop such reactions appear to do so within 1 month of starting treatment, approximately 80% appear to do so within 3 months.
Slovenian: Postmarketiška izkušnja je pokazala, da pri več kot polovici bolnikov, ki so razvili takšno razpoloženje, se je to pojavilo v prvem mesecu zdravljenja, pri približno 80 % pa v 3 mesecih.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Slovenian: Imetnik dovoljenja za promet se zaveže da bo izvedba študij in dodatne farmakovigilančne aktivnosti podrobno opisane v farmakovigilančnem planu.
English: The effects on body weight appeared to be consistent among men and women.
Slovenian: Učinek na telesno maso se je pri moških in ženskah ujemal.
English: The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
Slovenian: Varnost in učinkovitost rimonabanta nista ocenjeni v obdobju, daljšem od 2 let.
English: ACOMPLIA should not be taken during pregnancy.
Slovenian: Zdravila ACOMPLIA ne smete jemati med nosečnostjo.
English: Changes in HDL-C and TG in this population were similar to that of the non-diabetic population.
Slovenian: Spremembe holesterola HDL in trigliceridov so bile v tej populaciji podobne kot v nediabetični populaciji.
English: − if you are currently being treated for epilepsy
Slovenian: − če se trenutno zdravite zaradi epilepsije,
English: Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.
Slovenian: Glede na analizo populacijske farmakokinetike (starostni razpon od 18 do 81 let) ocenjujejo, da ima 75-letni bolnik 21 % večjo Cmax in 27 % večjo AUC kot 40-letni bolnik.
English: − if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA
Slovenian: − če ste preobčutljivi za (alergični na) rimonabant ali katerokoli sestavino zdravila ACOMPLIA
English: What ACOMPLIA is and what it is used for Before you take ACOMPLIA How to take ACOMPLIA Possible side effects
Slovenian: Kaj je zdravilo ACOMPLIA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ACOMPLIA Kako jemati zdravilo ACOMPLIA Možni neželeni učinki
English: Clinical study results
Slovenian: Rezultati kliničnih študij
English: LIST OF EXCIPIENTS Also contains lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo monohidrat.
English: Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)
Slovenian: Trenutno potekajoča velika depresivna motnja in/ali antidepresivno zdravljenje (glejte poglavje 4.4).
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: Only an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of the dose is excreted in the faeces as unchanged drug and metabolites.
Slovenian: Le približno 3 % odmerka rimonabanta se izloči z urinom, približno 86 % odmerka pa se izloči z blatom kot nespremenjeno zdravilo in presnovki.
English: Convulsions were observed sporadically in studies in rodents and macaques.
Slovenian: Konvulzije so sporadično opažali v študijah na glodalcih in makakih.
English: • Special Populations
Slovenian: • Posebne populacije
English: The treatment should be introduced with a mildly reduced calorie diet.
Slovenian: Zdravljenje se mora začeti z dieto z nekoliko zmanjšano vsebnostjo kalorij.
English: At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines.
Slovenian: V priporočenem odmerku ni pričakovati, da bi ACOMPLIA zmanjšala sposobnost upravljanja vozil in strojev.
English: As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Slovenian: Ko se telesna masa poveča s 65 na 200 kg, je pričakovano zmanjšanje Cmax 24 % in pričakovano povečanje Cdno za 5 %.
English: The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a wide concentration range.
Slovenian: Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika (> 99,9 %) in v širokem razponu koncentracij ne kaže saturacije.
English: In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast.
Slovenian: V kliničnih študijah so preiskovanci Zdravilo ACOMPLIA 20 mg jemali zjutraj, ponavadi pred zajtrkom.
English: Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded.
Slovenian: Čeprav so pri teh odmerkih opazili toksične učinke pri samicah-materah, ni mogoče izključiti povezave s terapijo.
English: Elimination:
Slovenian: Eliminacija:
English: It works by blocking specific receptors in the brain and fat tissues called CB1 receptors.
Slovenian: Deluje tako, da zavre posebne receptorje v možganih in maščobnem tkivu, ki jih imenujemo receptorji CB1.
English: The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Slovenian: Razlika v razpolovnem času je bila posledica razlik v perifernem volumnu porazdelitve zaradi manjše telesne mase japonskih preiskovancev.
English: ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
Slovenian: Varnost zdravila ACOMPLIA 20 mg so raziskali pri približno 2500 bolnikih, vključenih v študije, ki so proučevale presnovne učinke in učinke na zmanjšanje telesne mase pri čezmerno težkih in debelih bolnikih, ter pri približno 3800 bolnikih z drugimi indikacijami.
English: Patients who received ACOMPLIA 20 mg for one year were re-randomized to ACOMPLIA 20 mg or placebo.
Slovenian: Bolnike, ki so eno leto dobivali zdravilo ACOMPLIA 20 mg, so ponovno randomizirali na zdravilo ACOMPLIA 20 mg ali placebo.
English: Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo.
Slovenian: Rimonabant je selektiven antagonist kanabinoidnih receptorjev 1 (CB1), ki zavira farmakološke učinke kanabinoidnih agonistov in vitro in in vivo.
English: Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
Slovenian: Kognitivne raziskave v študijah klinične farmakologije so pokazale, da rimonabant nima pomembnega kognitivnega ali sedativnega učinka.
English: • Depressive disorders
Slovenian: • Depresivne motnje
English: Taking ACOMPLIA with food and drink ACOMPLIA should be taken once daily in the morning before breakfast.
Slovenian: Jemanje zdravila ACOMPLIA skupaj s hrano in pijačo Zdravilo ACOMPLIA morate vzeti enkrat na dan, zjutraj pred zajtrkom.
English: It is not known if rimonabant is excreted in human milk.
Slovenian: Ni znano, ali se rimonabant izloča v materinem mleku.
English: Post-Marketing
Slovenian: Postmarketinške izkušnje
English: Rimonabant 20 mg reduced the risk of weight regain.
Slovenian: Rimonabant v odmerku 20 mg je zmanjšal tveganje za ponovno povečanje telesne mase.
English: These were usually mild or moderate in severity and resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups.
Slovenian: Te motnje so bile ponavadi blage ali zmerne in so se v vseh primerih popravile (bodisi po korektivni terapiji ali prekinitvi rimonabanta) ter niso imele drugačnih značilnosti kot v kontrolnih skupinah.
English: Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/kg/day.
Slovenian: Vplive rimonabanta na pre- in postnatalni razvoj so raziskali pri podganah v odmerkih do 10 mg/kg/dan.
English: A similar increase in exposure is expected with other potent CYP3A4 inhibitors.
Slovenian: Podobno povečanje izpostavljenosti je mogoče pričakovati z drugimi močnimi zaviralci CYP3A4.
English: The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established.
Slovenian: Učinkovitost in varnost zdravljenja z rimonabantom pri bolnikih, starejših od 75 let, nista dovolj raziskani.
English: The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Slovenian: Delovanje zdravila ACOMPLIA se poveča, če hkrati uporabljate določena zdravila (t. i. zaviralce CYP3A4), npr.:
English: - You are advised to share the information in this leaflet with relatives or other relevant persons.
Slovenian: - S podatki v tem navodilu seznanite svoje sorodnike ali druge osebe, ki skrbijo za vas.
English: Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.
Slovenian: Zdravljenje mora obsegati splošne ukrepe, ki se uporabljajo pri prevelikem odmerjanju, npr. ohranitev prehodnih dihalnih poti, nadzorovanje srčno-žilnega delovanja ter splošne simptomatske in podporne ukrepe.
English: Gender: The pharmacokinetics of rimonabant are similar in female and male patients.
Slovenian: Spol: Farmakokinetika rimonabanta je pri bolnicah in bolnikih podobna.
English: Very common (≥10%); Common (≥1, <10%); Uncommon (≥0.1, <1%); Rare (≥0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Slovenian: Razvrstitev pričakovanih pogostnosti neželenih učinkov: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1,000 do < 1/100); redki (≥ 1/10,000 do < 1/1,000); zelo redki (< 1/10,000), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
English: The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered clinically relevant (for events < 1%).
Slovenian: Naslednja tabela (tabela 1) prikazuje vse neželene učinke, ki so se pojavili med zdravljenjem v s placebom kontroliranih študijah, pri bolnikih zdravljenih za zmanjšanje telesne mase in zaradi sorodnih presnovnih motenj, če je bila njihova incidenca statistično značilno večja kot pri placebu (za dogodke ≥1%) ali so bile ocenjene kot klinično pomembne (za dogodke <1%).
English: − Nervous disorders: convulsions, disturbance in attention, headache.
Slovenian: − bolezni živčevja: konvulzije, motnje pozornosti, glavobol.
English: Regarding reproductive parameters, at 30 mg/kg no differences were observed between treated animals and controls, at 60 mg/kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Slovenian: Kar zadeva reproduktivne parametre pri 30 mg/kg niso ugotovili razlik med zdravljenimi in kontrolnimi živalmi, pri 60 mg/kg so bili učinki še vedno opazni (zmanjšano število rumenih telesc, skupno število implantacij in plodov, sposobnih za življenje).
English: • Drug Interaction
Slovenian: • Interakcije z zdravili
English: Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development (see section 5.3).
Slovenian: Podatki iz študij na živalih sicer niso zadostni, vendar nakazujejo možne škodljive vplive na razvoj zarodka oz. ploda (glejte poglavje 5.3).
English: − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia.
Slovenian: − psihiatrična motnja: psihotične motnje vključno s halucinacijami, blodnjami in paranojo.
English: In obese patients, the elimination half-life is longer (about 16 days) than in non-obese patients (about 9 days) due to a larger volume of distribution.
Slovenian: Pri debelih bolnikih je eliminacijski razpolovni čas zaradi večjega volumna porazdelitve daljši (okrog 16 dni) kot pri bolnikih, ki niso debeli (okrog 9 dni).
English: Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%).
Slovenian: Sočasna uporaba ketokonazola (močnega zaviralca CYP3A4) je povečala AUC rimonabanta za 104% (95% napovedni interval: od 40% do 197%).