FrancophonIA/ELRC3.0 huggingface dataset:
English: ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Slovenian: ACOMPLIA je na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 in 98 tabletami,perforiranih pretisnih omotih za enkratni odmerek, ki vsebujejo 70 x 1 tableto in belih plastenkah z 28, 98 ali 500 tabletami.
English: The in vivo inhibitory effect on CYP2C8 has not been studied.
Slovenian: Zaviralni učinek na CYP2C8 in vivo ni raziskan.
English: There are reports in the literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the brain changes during development.
Slovenian: V literaturi je opisano, da se prostorska porazdelitev in gostota receptorjev CB1 v možganih med razvojem spreminjata tako pri glodalcih kot pri človeku.
English: The usual dose is one 20 mg tablet to be taken once daily in the morning before breakfast.
Slovenian: Običajni odmerek je ena 20 mg tableta; vzeti ga morate enkrat na dan, zjutraj pred zajtrkom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/344/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/06/344/007
English: Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.
Slovenian: Bikonveksne bele tablete v obliki solze z vtisnjeno oznako "20" na eni strani.
English: Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Slovenian: Obloga tablete: laktoza monohidrat, hipromeloza 15 mPa.s (E464), titanov dioksid (E171), makrogol 3000
English: Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Slovenian: Rimonabant in vitro ne zavira in ne inducira drugih encimov CYP ali P-glikoproteina (P-gp).
English: − if you currently suffer from depression
Slovenian: − če imate depresijo
English: The absolute bioavailability of rimonabant has not been determined.
Slovenian: Absolutna biološka uporabnost rimonabanta ni ugotovljena.
English: HOW TO TAKE ACOMPLIA
Slovenian: KAKO JEMATI ZDRAVILO ACOMPLIA
English: Following multiple once-daily doses of 20 mg to healthy subjects in the fasted state, maximum plasma concentrations of rimonabant are achieved in approximately 2 hours with steady state plasma levels achieved within 13 days (Cmax = 196 ± 28.1 ng/ml; Ctrough = 91.6 ± 14.1 ng/ml; AUC0-24 = 2960 ± 268 ng.h/ml).
Slovenian: Po večkratni uporabi 20 mg enkrat na dan na tešče pri zdravih preiskovancih doseže rimonabant največjo plazemsko koncentracijo v približno 2 urah, plazemsko koncentracijo v stanju dinamičnega ravnovesja pa v 13 dneh (Cmax = 196 ± 28,1 ng/ml; Cdno = 91,6 ± 14,1 ng/ml; AUC0-24 = 2960 ± 268 ng.h/ml).
English: These included headache, euphoria, fatigue and insomnia.
Slovenian: Ob tem so zabeležili le manj pomembne simptome, med katerimi so bili glavobol, evforija, utrujenost in nespečnost.
English: Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant.
Slovenian: Glede na podatke študij populacijske farmakokinetike blaga okvara ledvic ne vplivata na farmakokinetiko rimonabanta.
English: Patients with hepatic insufficiency:
Slovenian: Bolniki z insuficienco jeter:
English: - If any of the side effects get serious, or if you notice any side effect 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: − infections and infestations: sinusitis
Slovenian: − infekcijske in parazitske bolezni: sinuzitis,
English: Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Slovenian: Rimonabant ima in vitro veliko permeabilnost in ni substrat P-glikoproteina.
English: Paediatrics:
Slovenian: Pediatrični bolniki:
English: ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Slovenian: Zaradi pomanjkanja podatkov o učinkovitosti in varnosti uporaba zdravila ACOMPLIA pri otrocih pod 18 let ni priporočljiva.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Slovenian: V kliničnih študijah niso opazili škodljivih reakcij, v študijah na živalih pa so jih opazili pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti.
English: ACOMPLIA should be used with caution in patients over 75 years of age (see section 4.4).
Slovenian: Pri bolnikih, starejših od 75 let, zdravilo ACOMPLIA uporabljajte previdno (glejte poglavje 4.4).
English: − telithromycin (antibiotic)
Slovenian: − telitromicin (antibiotik),
English: Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant.
Slovenian: Pričakovati je mogoče, da sočasna uporaba induktorjev CYP3A4 zmanjša izpostavljenost rimonabantu.
English: In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
Slovenian: Med bolniki, ki so dobivali rimonabant v študijah, kontroliranih s placebom, je bil delež prekinitev zaradi neželenih reakcij 15,7%.
English: If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Slovenian: Če se med terapijo z rimonabantom diagnosticira depresija, se mora zdravljenje končati.
English: Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant.
Slovenian: Sočasna uporaba zaviralcev CYP3A4 poveča izpostavljenost rimonabantu.
English: Increased incidence and/or severity of clinical signs suggestive of increased tactile hyperesthesia were observed in rodent studies.
Slovenian: V študijah na glodalcih so ugotovili večjo incidenco in/ali izrazitost kliničnih znakov, ki nakazujejo povečano taktilno hiperestezijo.
English: Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
Slovenian: Rimonabant morate uporabljati previdno v kombinaciji z močnimi zaviralci CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirjem, telitromicinom, klaritromicinom, nefazodonom) (glejte poglavje 4.5).
English: Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro.
Slovenian: Rimonabant se in vitro presnavlja s CYP3A in amidohidrolazo (pretežno jetrno).
English: Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment.
Slovenian: Rimonabant se presnavlja v jetrih, zato je pri bolnikih z zmerno okvaro jeter potrebna previdnost.
English: It is estimated that approximately half of the mean improvement in HbA1c in patients receiving rimonabant 20 mg was beyond that expected from weight loss alone.
Slovenian: Ocenjujejo, da je približno polovica povprečnega izboljšanja HbA1c pri bolnikih, ki so dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase.
English: It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received rimonabant 20 mg was beyond that expected from weight loss alone.
Slovenian: Ocenjujejo, da je približno polovica ugotovljenega izboljšanja holesterola HDL in trigliceridov pri bolnikih, ki so dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase.
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le na recept.
English: One film-coated tablet contains 20 mg rimonabant.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg rimonabanta.
English: Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).
Slovenian: Pri bolnikih, ki so jemali zdravilo ACOMPLIA, so poročali o pojavu resnih duševnih motenj, vključno z depresijo ali motnjami razpoloženja (glejte poglavje MOŽNI NEŽELENI UČINKI).
English: In patients with current suicidal ideations and/or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
Slovenian: Pri bolnikih, ki imajo samomorilne misli in/ali bolnikih, ki so kdaj imeli samomorilne misli ali depresivno motnjo, se rimonabanta ne sme uporabljati, če koristi zdravljenja pri posameznem bolniku ne prevladajo nad temi tveganji (glejte poglavji 4.3 in 4.8).
English: What ACOMPLIA contains
Slovenian: Kaj vsebuje zdravilo ACOMPLIA
English: Joint sprain *frequency is based only on reports in obese or overweight diabetic patients.
Slovenian: * pogostnost temelji na poročilih pri debelih ali čezmerno težkih bolnikih s sladkorno boleznijo.
English: − gastrointestinal disorders: stomach discomfort, dry mouth.
Slovenian: − bolezni prebavil: nelagodje v želodcu, suha usta.
English: − if you have impaired liver function
Slovenian: − če imate okvarjeno delovanje jeter,
English: However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
Slovenian: Vendar rimonabant in vitro rahlo zavira CYP2C8.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
Slovenian: A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
English: In the non-diabetic studies including a mixed population of subjects with/without (treated) dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed.
Slovenian: Obvladovanje telesne mase in dodatni dejavniki tveganja V študijah nediabetičnih bolnikov, vključno z mešano populacijo preiskovancev z (zdravljeno) dislipidemijo ali brez nje, so (po enem letu) ugotovili zvišanje holesterola HDL in znižanje trigliceridov.
English: • Other psychiatric conditions
Slovenian: • Druge duševne motnje
English: Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable with the clinical exposures.
Slovenian: V študijah embrio-fetalnih toksičnih učinkov pri kuncih so opažali sporadične malformacije (anencefalija, mikrooftalmija, razširitev možganskih prekatov in omfalokela) ob odmerkih, ki so povzročili izpostavljenosti, podobne kliničnim izpostavljenostim.
English: ACOMPLIA 20 mg film-coated tablets (rimonabant)
Slovenian: ACOMPLIA 20 mg filmsko obložene tablete (rimonabant)
English: This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Slovenian: Neprozorne bele plastenke iz HDPE z 28, 98 ali 500 filmsko obloženimi tabletami.
English: Each tablet contains 20 mg rimonabant.
Slovenian: Ena tableta vsebuje 20 mg rimonabanta.
English: In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported.
Slovenian: V študijah prenašanja posamičnega odmerka so omejenemu številu preiskovancev dali odmerke do 300 mg.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 98 filmsko obloženih tablet 500 filmsko obloženih tablet
English: • Diabetic patients
Slovenian: • Bolniki s sladkorno boleznijo
English: 70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
Slovenian: Perforirani pretisni omoti za enkratni odmerek iz PVC-aluminija s 70 x 1 filmsko obloženo tableto.
English: The absolute change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%).
Slovenian: Po enem letu je bila absolutna sprememba HbA1c z 20 mg rimonabanta -0,6 (izhodiščno 7,3 %) in s placebom +0,1 (izhodiščno 7,2 %).
English: PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Slovenian: Pretisni omoti iz PVC-aluminija s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami.
English: The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001).
Slovenian: Razlika je bila statistično značilna (razlika 7,9 %, IZ95 % 6,6 %, 9,2 %; p<0,001).
English: Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Slovenian: Zdravniku morate povedati, če otroka dojite ali ga nameravate dojiti.
English: Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, p<0.001).
Slovenian: Razlike so bile statistično značilne (razlika -0,7 %, IZ95 % -0,80, -0,5; p<0,001).
English: Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
Slovenian: Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat
English: If you forget to take ACOMPLIA Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Slovenian: Ne vzenite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Nausea
Slovenian: Dojenje.
English: The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p< 0.001).
Slovenian: Razlika je bila statistično značilna (razlika13,3 %, IZ95 % -16,5 %, -10,2 %; p<0,001).
English: ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and
Slovenian: Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.4 in
English: Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Slovenian: Znaki in simptomi povezani z depresijo so lahko: žalost, depresivno razpoloženje, izguba interesa za aktivnosti, pri katerih ste nekoč uživali, vznemirjenost, razdražljivost, upočasnjena, zavrta aktivnost, slaba koncentracija, tesnoba, težave pri spanju (nespečnost), misli ali pogovor o smrti ali samomoru.
English: For the triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 1.62 mmol/l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/l).
Slovenian: Trigliceridi so se ob 20 mg rimonabanta v povprečju znižali za 6,9 % (izhodiščni trigliceridi 1,62 mmol/l), ob placebu pa zvišali za 5,8 % (izhodiščni trigliceridi 1,65 mmol/l).
English: Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Slovenian: Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat Obloga tablete: laktoza monohidrat, hipromeloza 15 mPa.s (E464), titanov dioksid (E171), makrogol
English: ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
Slovenian: Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
English: The active ingredient of ACOMPLIA is rimonabant.
Slovenian: Zdravilna učinkovina v zdravilu ACOMPLIA je rimonabant.
English: The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in the table 2.
Slovenian: Tabela 2 prikazuje odstotek bolnikov, ki so po enem letu zdravljenja izgubili 5 % oz. 10 % izhodiščne telesne mase.
English: No treatment-related malformations were seen in the rat.
Slovenian: Pri podganah niso ugotovili z zdravljenjem povezanih malformacij.
English: − ketoconazole (antifungal medicine)
Slovenian: − ketokonazol (zdravilo proti glivicam),
English: − itraconazole (antifungal medicine)
Slovenian: − itrakonazol (zdravilo proti glivicam),
English: Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle label for the presentations of 28, 98 and 500 film-coated tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla z 28, 98 in 500 filmsko obloženimi tabletami v plastenkah iz HDPE / nalepka za plastenko iz HDPE oprem z 28, 98 in 500 filmsko obloženimi tabletami
English: Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
Slovenian: Pri 3,2% debelih bolnikov oziroma čezmerno težkih bolnikih, pri katerih so bili prisotni tudi dejavniki tveganja in ki so dobivali rimonabant 20 mg, so poročali o depresivnih motnjah.
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Slovenian: Če se kateri od zgoraj navedenih simptomov pojavi ali poslabša po začetku zdravljenja, morate o tem obvestiti zdravnika.
English: Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg.
Slovenian: Nad 20 mg je AUC naraščala manj kot sorazmerno odmerku.
English: in people under 18 years of age.
Slovenian: Podatkov o uporabi zdravila ACOMPLIA pri osebah, mlajših od 18 let,
English: No dosage adjustment is required in elderly (see section 5.2).
Slovenian: Pri starejših bolnikih odmerjanja ni treba prilagoditi (glejte poglavje 5.2).
English: Marketing Authorisation Holder sanofi-aventis
Slovenian: Imetnik dovoljenja za promet sanofi-aventis
English: Tendonitis Muscle cramp Muscle spasms
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva tendinitis mišični krč mišični spazmi
English: NAME OF THE MEDICINAL PRODUCT ACOMPLIA 20 mg film-coated tablets rimonabant
Slovenian: IME ZDRAVILA ACOMPLIA 20 mg filmsko obložene tablete
English: Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Slovenian: Med sočasno uporabo zdravila ACOMPLIA in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja, telitromicina, klaritromicina, nefazodona) je potrebna previdnost.
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis
English: sanofi-aventis 174 avenue de France F-75013 Paris France
Slovenian: sanofi-aventis 174 avenue de France F-75013 Paris Francija
English: No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni potrebno prilagoditi (glejte poglavje 5.2).
English: For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/l).
Slovenian: Ob 20 mg rimonabanta se je holesterol HDL v povprečju zvišal za 16,4 % (izhodiščni holesterol HDL 1,24 mmol/l), ob placebu pa za 8,9 % (izhodiščni holesterol HDL 1,21 mmol/l).
English: In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo.
Slovenian: V kliničnih preskušanjih se pojavnost epileptičnih napadov pri bolnikih, ki so prejemali rimonabant ni razlikovala od pojavnosti pri bolnikih, ki so prejemali placebo, vendar pa je treba rimonabant pri teh bolnikih uporabljati previdno.
English: No dosage adjustment is required for patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni potrebno prilagoditi.
English: − Skin and subcutaneous tissue disorders: rash.
Slovenian: − bolezni kože in podkožja: izpuščaj.
English: The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p< 0.001).
Slovenian: Razlika v povprečni spremembi telesne mase med prejemniki 20 mg rimonabanta in prejemniki placeba je bila 3,8 kg (IZ95 % -5,0, -2,6, p < 0,001).
English: Weight Management
Slovenian: Obvladovanje telesne mase
English: Rimonabant has not been studied in patients being treated for epilepsy.
Slovenian: Pri bolnikih, ki so se zdravili zaradi epilepsije, uporabe rimonabanta niso proučevali.
English: ACOMPLIA 20 mg
Slovenian: ACOMPLIA 20 mg placebo
English: Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
Slovenian: Med postmarketiško izkušnjo so poročali o naslednjih neželenih učinkih (pogostnost neznana): krči, motnje pozornosti, privid (napačno prepričanje), paranoja, izpuščaj, glavobol in bolečina v trebuhu.
English: The prescriber should carefully investigate if the patient has had a depressive disorder in the past in order to evaluate the potential risks with rimonabant treatment.
Slovenian: Pri vrednotenju možnih tveganj zdravljenja z rimonabantom mora zdravnik skrbno preveriti, če je bolnik kdaj imel depresivno motnjo.
English: Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.
Slovenian: Pri bolnikih z nenadzorovanimi resnimi duševnimi motnjami zdravljenja z rimonabantom ne priporočamo.
English: Memory loss Dizziness Hypoaesthesia Sciatica Paresthesia
Slovenian: Bolezni živčevja poslabšanje spomina omotica hipestezija išias parestezija letargija tremor
English: Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites.
Slovenian: Rimonabant se v glavnem izloča s presnovo in nadaljnjo izločitvijo presnovkov v žolču.
English: HOW TO STORE ACOMPLIA
Slovenian: SHRANJEVANJE ZDRAVILA ACOMPLIA
English: No adverse effect of rimonabant treatment was observed on EEG patterns in rats.
Slovenian: Pri podganah niso ugotovili neželenega vpliva rimonabanta na vzorec EEG.
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Injury, Poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve padec kontuzija zvin sklepa
English: Weight loss at two years was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p< 0.001).
Slovenian: Zmanjšanje telesne mase po dveh letih je bilo pri bolnikih, ki so dobivali zdravilo ACOMPLIA 20 mg, 5,1 kg in pri bolnikih, ki so dobivali placebo, 1,2 kg (razlika -3,8 kg, IZ95 % -4,4, -3,3; p<0,001).
English: Diarrhoea Vomiting
Slovenian: Žilne bolezni valovi vročine
English: The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Slovenian: Sočasna uporaba rimonabanta ni pomembno spremenila farmakokinetike kombiniranega peroralnega kontraceptiva z etinilestradiolom/levonorgestrelom v stanju dinamičnega ravnovesja.
English: The active substance is rimonabant.
Slovenian: Zdravilna učinkovina je rimonabant.
English: MARKETING AUTHORIZATION NUMBER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Slovenian: O bolnikih z zmerno okvaro ledvic so na voljo le omejeni podatki.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s 14, 28, 30, 56, 70, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje hiperhidroza nočno znojenje