natgillin/translations-raw huggingface dataset:
It is not known if ADENURIC may harm your unborn child. ADENURIC should not be used during pregnancy. 
Ni znano, ali zdravilo ADENURIC škodljivo vpliva na nerojenega otroka.
Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience. 
Izkušnje v obdobju po trženju kažejo, da so se redko pojavile resne alergijske/preobčutljivostne reakcije, vključno z življenjsko nevarnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in akutno anafilaktično reakcijo/šokom.
Seven hundred sixty (760) patients were randomized: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). 
Naključno je bilo razvrščenih sedemsto šestdeset (760) bolnikov: zdravilo ADENURIC 80 mg enkrat na dan (n=256), zdravilo ADENURIC 120 mg enkrat na dan (n=251) ali alopurinol 300 mg enkrat na dan (n=253).
Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary. 
Kolhicin/indometacin/hidroklorotiazid/varfarin Febuksostat se lahko daje sočasno s kolhicinom ali indometacinom brez prilagoditve odmerka febuksostata ali zdravilne učinkovine, ki se daje hkrati.
Two thousand and two hundred-sixty nine (2269) patients were randomized: ADENURIC 40 mg QD (n=757), ADENURIC 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756). 
Skupno je bilo vključenih 2.269 bolnikov: ADENURIC 40 mg na dan (n=757), ADENURIC 80 mg na dan (n=756) ali alopurinol 300/200 mg na dan (n=756).
6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively. 
V študiji CONFIRMS je bil delež bolnikov, pri katerih je bil dosežen primarni opazovani dogodek učinkovitosti (sUA < 6,0 mg/dl pri zadnjem pregledu) in z začetno vrednostjo sečne kisline ≥ 10 mg/dl, ki so bili zdravljeni z 40 mg febuksostata enkrat na dan 27 % (66/249), 80 mg febuksostata enkrat na dan 49 % (125/254) v primerjavi z 31 % (72/230) bolnikov zdravljenih z 300 mg/200 mg enkrat na dan alopurinola.
EU/1/08/447/001 28 film-coated tablets EU/1/08/447/002 84 film-coated tablets EU/1/08/447/005 14 film-coated tablets EU/1/08/447/006 42 film-coated tablets EU/1/08/447/007 56 film-coated tablets EU/1/08/447/008 98 film-coated tablets EU/1/08/447/013 14 film-coated tablets EU/1/08/447/014 28 film-coated tablets EU/1/08/447/015 42 film-coated tablets EU/1/08/447/016 56 film-coated tablets EU/1/08/447/017 84 film-coated tablets EU/1/08/447/018 98 film-coated tablets 
EU/1/08/447/001 28 filmsko obloženih tablet EU/1/08/447/002 84 filmsko obloženih tablet EU/1/08/447/005 14 filmsko obloženih tablet EU/1/08/447/006 42 filmsko obloženih tablet EU/1/08/447/007 56 filmsko obloženih tablet EU/1/08/447/008 98 filmsko obloženih tablet EU/1/08/447/013 14 filmsko-obloženih tablet EU/1/08/447/014 28 filmsko-obloženih tablet EU/1/08/447/015 42 filmsko-obloženih tablet EU/1/08/447/016 56 filmsko-obloženih tablet EU/1/08/447/017 84 filmsko-obloženih tablet EU/1/08/447/018 98 filmsko-obloženih tablet
Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with ADENURIC 40-240 mg QD. 
Analize populacijske farmakokinetike/farmakodinamike so bile izvedene pri 211 bolnikih s hiperurikemijo in protinom, zdravljenih z zdravilom ADENURIC 40-240 mg enkrat na dan. Na splošno se parametri farmakokinetike febuksostata, ocenjeni v teh analizah, ujemajo s tistimi, ki so jih pridobili pri zdravih osebah, kar kaže, da so zdrave osebe ustrezne za oceno farmakokinetike/farmakodinamike pri bolnikih s protinom.
EU/1/08/447/003 28 film-coated tablets EU/1/08/447/004 84 film-coated tablets EU/1/08/447/009 14 film-coated tablets EU/1/08/447/010 42 film-coated tablets EU/1/08/447/011 56 film-coated tablets EU/1/08/447/012 98 film-coated tablets EU/1/08/447/019 14 film-coated tablets EU/1/08/447/020 28 film-coated tablets EU/1/08/447/021 42 film-coated tablets EU/1/08/447/022 56 film-coated tablets EU/1/08/447/023 84 film-coated tablets EU/1/08/447/024 98 film-coated tablets 
EU/1/08/447/003 28 filmsko obloženih tablet EU/1/08/447/004 84 filmsko obloženih tablet EU/1/08/447/009 14 filmsko obloženih tablet EU/1/08/447/010 42 filmsko obloženih tablet EU/1/08/447/011 56 filmsko obloženih tablet EU/1/08/447/012 98 filmsko obloženih tablet EU/1/08/447/019 14 filmsko-obloženih tablet EU/1/08/447/020 28 filmsko-obloženih tablet EU/1/08/447/021 42 filmsko-obloženih tablet EU/1/08/447/022 56 filmsko-obloženih tablet EU/1/08/447/023 84 filmsko-obloženih tablet EU/1/08/447/024 98 filmsko-obloženih tablet
46% and 38%, of patients on final stable treatment of febuxostat 80 or 120 mg QD, respectively, had complete resolution of the primary palpable tophus from baseline to the Final Visit. 
Pri zaključnem obisku je bilo 46 % oziroma 38 % bolnikov stabilnih pri zdravljenju s febuksostatom 80 mg oziroma 120 mg enkrat na dan s popolnim razkrojem primarno tipljivega tofa.
(n=519) 1 results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses. 
(n=519) 1 za analize so bili zbrani podatki bolnikov, ki so prejemali bodisi 100 mg enkrat na dan (n=10: bolniki s serumskim kreatininom > 1,5 in  2,0 mg/dl) ali 300 mg enkrat na dan (n=509) * p < 0,001 v primerjavi z alopurinolom, # p < 0,001 v primerjavi z 80 mg
Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, non-purine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar. 
Febuksostat je močan, nepurinski selektivni zaviralec ksantinske oksidaze (NP-SIXO) z vrednostjo zaviranja Ki in vitro manj kot en nanomol na liter.
NAME OF THE MARKETING AUTHORISATION HOLDER 
Imetnik dovoljenja za promet:
In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03; 95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73). 
V preskušanju CARES iz obdobja trženja (glejte poglavje 5.1 za bolj podroben opis študije), je bila stopnja MACE (Major Adverse Cardiovascular Events) v skupini, ki je prejemala febuksostat podobna kot v skupini, ki je prejemala alopurinol (razmerje ogroženosti [HR - hazard ratio] 1,03; 95% interval zaupanja [IZ] 0,87-1,23), vendar je bil delež srčno-žilnih smrti večji v skupini zdravljeni s febuksostatom (4,3% v primerjavi z 3,2% bolnikov; HR 1,34; 95% IZ 1,03-1,73).
The ability of ADENURIC to lower serum uric acid levels was prompt and persistent. 
Zdravilo ADENURIC je takoj in dolgotrajno znižalo vrednosti sečne kisline v serumu.
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. 
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.
How to store ADENURIC 
Shranjevanje zdravila ADENURIC
• 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) 
• 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,
ADENURIC showed a superior and faster urate lowering activity compared to allopurinol. 
V primerjavi z alopurinolom je zdravilo ADENURIC imelo boljši in hitrejši učinek na zmanjšanje sečne kisline.
ADENURIC 120 mg film-coated tablets Febuxostat 
ADENURIC 120 mg filmsko obložene tablete febuksostat
ADENURIC 80 mg film-coated tablets Febuxostat 
ADENURIC 80 mg filmsko obložene tablete febuksostat
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). 
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).
Talk to your doctor before taking ADENURIC: 
Pred začetkom jemanja zdravila ADENURIC se posvetujte s svojim zdravnikom ali s farmacevtom:
Tablet core 
Obloga tablete
Diarrhoea**, nausea 
Pogosti driska**, navzea
ADENURIC 80 mg tablets Febuxostat 
IME ZDRAVILA ADENURIC 80 mg tablete febuksostat
ADENURIC 120 mg tablets Febuxostat 
IME ZDRAVILA ADENURIC 120 mg tablete febuksostat
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. 
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 %).
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%). 
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.
Nervousness 
Bolezni živčevja
Opadry II, Yellow, 85F42129 containing: Polyvinyl alcohol 
Opadry II rumena 85F42129, ki vsebuje: polivinil alkohol titanov dioksid (E171) makrogol 3350 smukec rumeni železov oksid (E172)
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. 
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.
Each tablet contains 80 mg of febuxostat. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg febuksostata.
Rare Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness 
Redki toksična epidermalna nekroliza*, Stevens-Johnsonov sindrom*,
Each tablet contains 120 mg of febuxostat. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 120 mg febuksostata.
ADENURIC 120 mg film-coated tablets 
IME ZDRAVILA ADENURIC 120 mg filmsko obložene tablete
ADENURIC 80 mg film-coated tablets 
IME ZDRAVILA ADENURIC 80 mg filmsko obložene tablete
Oedema 
Protin
Gout flares 
Patheon France
Package leaflet: Information for the user ADENURIC 80 mg film-coated tablets ADENURIC 120 mg film-coated tablets 
ADENURIC 80 mg filmsko obložene tablete ADENURIC 120 mg filmsko obložene tablete febuksostat
Liver function abnormalities** Uncommon 
Pogosti nenormalni rezultati jetrne funkcije** Občasni holelitiaza
− if you are less than 18 years of age. 
− če ste mlajši od 18 let.
There are no adequate or well-controlled studies in pregnant women. 
Ni zadostnih ali dobro kontroliranih študij pri nosečnicah.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19 June 2006 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 19 junij 2006
Effect of food: 
Vpliv hrane:
Most of the observed weight reduction was obtained within the first nine months of treatment. 
Večina opaženega zmanjšanja telesne mase je bila dosežena v prvih devetih mesecih zdravljenja.
Use in pregnancy is, therefore, not recommended. 
Uporaba med nosečnostjo zato ni priporočljiva.
Elderly patients have slightly higher exposure than young patients. 
Izpostavljenost starejših bolnikov je rahlo večja kot izpostavljenost mladih bolnikov.
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use. 
Obnovljen načrt upravljanja tveganja mora biti izdelan kot so CHMP smernice za sistem upravljanja tveganja za zdravila za humano uporabo.
WHAT ACOMPLIA IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO ACOMPLIA IN ZA KAJ GA UPORABLJAMO
The patient should be monitored and treated appropriately. 
Bolnik mora biti primerno nadzorovan in zdravljen.
Approximately 80% of the population were women, 87% Caucasian and 9% Black. 
Približno 80 % populacije so bile ženske, 87 % je bilo belcev in 9% črncev.
Obesity is a condition that can be associated with depressive disorders. 
Debelost je stanje, ki je lahko povezano z depresivnimi motnjami.
Table 2: 
Tabela 2:
The potential relevance of this to administration of a CB1 antagonist is unknown. 
Potencialni pomen tega za uporabo antagonista CB1 ni znan.
Patients should be instructed not to increase their dose of ACOMPLIA. 
Bolnikom morate naročiti, naj ne povečujejo odmerka zdravila ACOMPLIA.
In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies. 
Skupaj je bilo v klinične študije 2. in 3. faze vključenih več kot 6800 bolnikov.
− if you have previously suffered from depression or have had suicidal thoughts 
− če ste kdaj imeli depresijo ali ste razmišljali o samomoru,
INFORMATION IN BRAILLE ACOMPLIA 
PODATKI V BRAILLOVI PISAVI ACOMPLIA
Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health. 
Zdravnik vam bo svetoval potrebno dieto in raven telesne dejavnosti, ki bosta ustrezali vašemu stanju in splošnemu zdravju.
There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose. 
Specifičnega antidota za rimonabant ni, zato je treba v primeru prevelikega odmerjanja uvesti ustrezne podporne ukrepe.
A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies. 
Prokonvulzivno delovanje rimonabanta so ugotovili v eni od dveh študij farmakološke varnosti.
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races. 
Bolniki črnci imajo lahko do 31 % manjšo Cmax in 43 % manjšo AUC kot bolniki drugih ras.
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide. 
Depresivne motnje so lahko povezane z večjim tveganjem za samomorilne misli, samopoškodovanje in samomor.
In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals. 
V nekaterih primerih - ne pa v vseh - je bila sprožitev konvulzij po vsem sodeč povezana s stresom zaradi postopka, npr. rokovanja z živalmi.
− if you have diabetes (see section 4) 
− če imate sladkorno bolezen (glejte poglavje 4),
The pharmacokinetic profile demonstrates that a plateau in exposures is reached at 180 mg. 
Farmakokinetični profil kaže, da je plato izpostavljenosti dosežen s 180 mg.
Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself. 
Depresivno razpoloženje se lahko razvije pri bolnikih, ki nimajo očitnih dejavnikov tveganja, razen debelosti same.
5 How to store ACOMPLIA Further information 
5 Shranjevanje zdravila ACOMPLIA Dodatne informacije
Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC). 
Omejeni podatki kažejo na večjo izpostavljenost pri bolnikih z zmerno okvaro ledvic (40% povečanje AUC).
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. 
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.
Important information about some of the ingredients of ACOMPLIA ACOMPLIA tablets include lactose. 
Pomembne informacije o nekaterih sestavinah zdravila ACOMPLIA Tablete ACOMPLIA vsebujejo laktozo.
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. 
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.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan. 
Imetnik dovoljenja za promet se zaveže da bo izvedba študij in dodatne farmakovigilančne aktivnosti podrobno opisane v farmakovigilančnem planu.
The effects on body weight appeared to be consistent among men and women. 
Učinek na telesno maso se je pri moških in ženskah ujemal.
The safety and efficacy of rimonabant have not been evaluated beyond 2 years. 
Varnost in učinkovitost rimonabanta nista ocenjeni v obdobju, daljšem od 2 let.
ACOMPLIA should not be taken during pregnancy. 
Zdravila ACOMPLIA ne smete jemati med nosečnostjo.
Changes in HDL-C and TG in this population were similar to that of the non-diabetic population. 
Spremembe holesterola HDL in trigliceridov so bile v tej populaciji podobne kot v nediabetični populaciji.
− if you are currently being treated for epilepsy 
− če se trenutno zdravite zaradi epilepsije,
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. 
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.
− if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA 
− če ste preobčutljivi za (alergični na) rimonabant ali katerokoli sestavino zdravila ACOMPLIA
What ACOMPLIA is and what it is used for Before you take ACOMPLIA How to take ACOMPLIA Possible side effects 
Kaj je zdravilo ACOMPLIA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ACOMPLIA Kako jemati zdravilo ACOMPLIA Možni neželeni učinki
Clinical study results 
Rezultati kliničnih študij
LIST OF EXCIPIENTS Also contains lactose monohydrate. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo monohidrat.
Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4) 
Trenutno potekajoča velika depresivna motnja in/ali antidepresivno zdravljenje (glejte poglavje 4.4).
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
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. 
Le približno 3 % odmerka rimonabanta se izloči z urinom, približno 86 % odmerka pa se izloči z blatom kot nespremenjeno zdravilo in presnovki.
Convulsions were observed sporadically in studies in rodents and macaques. 
Konvulzije so sporadično opažali v študijah na glodalcih in makakih.
• Special Populations 
• Posebne populacije
The treatment should be introduced with a mildly reduced calorie diet. 
Zdravljenje se mora začeti z dieto z nekoliko zmanjšano vsebnostjo kalorij.
At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines. 
V priporočenem odmerku ni pričakovati, da bi ACOMPLIA zmanjšala sposobnost upravljanja vozil in strojev.
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%. 
Ko se telesna masa poveča s 65 na 200 kg, je pričakovano zmanjšanje Cmax 24 % in pričakovano povečanje Cdno za 5 %.
The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a wide concentration range. 
Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika (> 99,9 %) in v širokem razponu koncentracij ne kaže saturacije.
In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast. 
V kliničnih študijah so preiskovanci Zdravilo ACOMPLIA 20 mg jemali zjutraj, ponavadi pred zajtrkom.
Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded. 
Čeprav so pri teh odmerkih opazili toksične učinke pri samicah-materah, ni mogoče izključiti povezave s terapijo.
It works by blocking specific receptors in the brain and fat tissues called CB1 receptors. 
Deluje tako, da zavre posebne receptorje v možganih in maščobnem tkivu, ki jih imenujemo receptorji CB1.
The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects. 
Razlika v razpolovnem času je bila posledica razlik v perifernem volumnu porazdelitve zaradi manjše telesne mase japonskih preiskovancev.
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. 
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.
Patients who received ACOMPLIA 20 mg for one year were re-randomized to ACOMPLIA 20 mg or placebo. 
Bolnike, ki so eno leto dobivali zdravilo ACOMPLIA 20 mg, so ponovno randomizirali na zdravilo ACOMPLIA 20 mg ali placebo.
Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo. 
Rimonabant je selektiven antagonist kanabinoidnih receptorjev 1 (CB1), ki zavira farmakološke učinke kanabinoidnih agonistov in vitro in in vivo.
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect. 
Kognitivne raziskave v študijah klinične farmakologije so pokazale, da rimonabant nima pomembnega kognitivnega ali sedativnega učinka.
• Depressive disorders 
• Depresivne motnje
Taking ACOMPLIA with food and drink ACOMPLIA should be taken once daily in the morning before breakfast. 
Jemanje zdravila ACOMPLIA skupaj s hrano in pijačo Zdravilo ACOMPLIA morate vzeti enkrat na dan, zjutraj pred zajtrkom.
It is not known if rimonabant is excreted in human milk. 
Ni znano, ali se rimonabant izloča v materinem mleku.
Post-Marketing 
Postmarketinške izkušnje