FrancophonIA/ELRC3.0 huggingface dataset:
English: - You are advised to share the information in this leaflet with relatives or other relevant persons.
Estonian: - On soovitatav, et jagaksite käesolevas infolehes olevat teavet oma sugulaste või teiste asjassepuutuvate isikutega.
English: • OTHER CONDITIONS
Estonian: ● MUUD TINGIMUSED
English: The patient should be monitored and treated appropriately.
Estonian: Patsienti tuleb korralikult jälgida ja ravida.
English: An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
Estonian: Peab esitama kaasajastatud riskijuhtimisplaani vastavuses CHMP juhisega inimtervishoius kasutatavate ravimite riskijuhtimissüsteemide kohta.
English: Suicidal ideation Aggressiveness Aggressive behaviour
Estonian: Suitsidaalne mõtlemine Agressiivsus Agressiivne käitumine
English: Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Estonian: Depressiivsed reaktsioonid võivad esineda patsientidel, kellel pole ilmseid riskifaktoreid peale rasvumise enda.
English: A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Estonian: Rimonabanti prokonvulsiivset aktiivsust täheldati ühes kahest farmakoloogilise ohutuse uuringust.
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.
Estonian: Turustamisjärgsete kogemuste järgi, enam kui pooltel patsientidest, kel need reaktsioonid tekivad, ilmnevad need 1 kuu jooksul pärast ravi algust, ligikaudu 80%-l 3 kuu jooksul.
English: Difference (CI 95%)
Estonian: Erinevus (CI95%)
English: The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
Estonian: Rimonabanti efektiivsust ja ohutust ei ole hinnatud kauem kui 2 aastat.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: ● TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA
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.
Estonian: Kui te unustate ACOMPLIA't võtta Võtke tablett kohe kui teile meenub, kuid ärge võtke kahekordset annust, et võtmata annust tasa teha.
English: ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Estonian: ACOMPLIA't ei soovitata kasutada alla 18 aasta vanuste laste raviks, sest puuduvad andmed efektiivsuse ja ohutuse kohta.
English: WHAT ACOMPLIA IS AND WHAT IT IS USED FOR
Estonian: MIS RAVIM ON ACOMPLIA JA MILLEKS SEDA KASUTATAKSE
English: Injury, Poisoning and procedural complications
Estonian: Vigastus, mürgistus ja protseduuri tüsistused
English: INFORMATION IN BRAILLE ACOMPLIA
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) ACOMPLIA
English: What ACOMPLIA is and what it is used for Before you take ACOMPLIA How to take ACOMPLIA Possible side effects
Estonian: Mis ravim on ACOMPLIA ja milleks seda kasutatakse Mida on vaja teada enne ACOMPLIA võtmist Kuidas ACOMPLIA't võtta Võimalikud kõrvaltoimed
English: Signs and symptoms associated with depression could be:
Estonian: Depressiooniga seotud sümptomid ja ilmingud võivad olla alljärgnevad:
English: Most of the observed weight reduction was obtained within the first nine months of treatment.
Estonian: Enamus täheldatud kaalukaotusest saavutati esimese 9 ravikuuga.
English: Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)
Estonian: Samaaegne raske depressioon ja/või käimasolev antidepressiivne ravi (vt lõik 4.4).
English: • Diabetic patients
Estonian: • Diabeetilised patsiendid
English: ACOMPLIA should not be taken during pregnancy.
Estonian: ACOMPLIA't ei tohi võtta raseduse ajal.
English: Taking ACOMPLIA with food and drink ACOMPLIA should be taken once daily in the morning before breakfast.
Estonian: ACOMPLIA võtmine koos toidu ja joogiga ACOMPLIA't tuleb võtta üks kord päevas hommikul enne hommikusööki.
English: You need to start and continue a reduced calorie diet and a physical activity program to get best results.
Estonian: Te peate alustama ja järgima kalorivaest dieeti ning kehalise aktiivsuse programmi, saavutamaks paremaid ravitulemusi.
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.
Estonian: 3. faasi uuringutes osalenud patsiendid järgisid dietoloogi määratud piiratud dieeti ning neile soovitati kehalise koormuse suurendamist.
English: The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a wide concentration range.
Estonian: Seondumine inimese vereplasma valkudega in vitro on kõrge (> 99,9 %) ja mitte-satureeriv laias kontsentratsioonivahemikus.
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.
Estonian: Ravimi väljakirjutaja peab hoolikalt uurima, kas patsiendil on minevikus esinenud depressiivseid häireid, hindamaks rimonabantiga ravimise võimalikke ohte.
English: Patients should be instructed not to increase their dose of ACOMPLIA.
Estonian: Patsiente peab teavitama, et ACOMPLIA annust ei tohi suurendada.
English: Do not take this medicine when breast-feeding.
Estonian: Ärge võtke seda ravimit, kui te toidate last rinnaga.
English: Elderly patients have slightly higher exposure than young patients.
Estonian: Eakatel on süsteemne saadavus pisut kõrgem kui noortel patsientidel.
English: Experience in patients over 75 years and Orientals/Asians was limited.
Estonian: Kogemused üle 75 aasta vanuste ja idamaa/aasia patsientidega on piiratud.
English: Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development (see section 5.3).
Estonian: Loomkatsetes saadud andmed ei ole lõplikud, kuid viitavad võimalikule kahjulikule mõjule embrüonaalsele/loote arengule (vt lõik 5.3).
English: Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Estonian: Mustanahalistel võib Cmax olla 31 % madalam ja AUC 43 % madalam kui teistesse rassidesse kuuluvatel patsientidel.
English: The treatment should be introduced with a mildly reduced calorie diet.
Estonian: Ravi peab alustama koos mõõdukalt vähendatud kalorsusega dieediga.
English: Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Estonian: 80 % uuringupopulatsioonist olid naised, 87 % europiidsest rassist ja 9 % mustanahalised.
English: Effect of food:
Estonian: Toidu mõju
English: Clinical study results
Estonian: Kliiniliste uuringute tulemused
English: Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01
Estonian: Farmakoterapeutiline grupp: Tüsedusevastased ained, ATC-kood: A08AX01
English: Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.
Estonian: Teie arst annab teile soovitusi dieedi tüübi ja nõutava kehalise aktiivsuse kohta, mis sobivad teie seisundi ja tervisliku olukorraga.
English: Classification of expected frequencies of undesirable effects:
Estonian: Kõrvaltoimete klassifikatsioon oodatava esinemissageduse alusel:
English: The potential relevance of this to administration of a CB1 antagonist is unknown.
Estonian: KB-1 antagonisti sellise manustamise võimalik tähtsus ei ole teada.
English: Obesity is a condition that can be associated with depressive disorders.
Estonian: Rasvumine on seisund, millega seoses võib esineda depressiivseid häireid.
English: ACOMPLIA 20 mg was effective in maintaining weight loss up to two years.
Estonian: ACOMPLIA 20 mg oli efektiivne kaalulanguse säilitamisel kuni 2 aastat.
English: The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Estonian: Müügiloa hoidja peab tagama, et ravimi ohutusjärelvalve süsteem on olemas ja toimib enne ravimi turule toomist.
English: Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded.
Estonian: Ehkki nimetatud annuste korral täheldati toksilisust emasloomadele, ei saa välistada seost raviga.
English: Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment.
Estonian: Patsiente peaks aktiivselt jälgima psühhiaatriliste häirete nähtude ja sümptomite ilmnemise suhtes, eriti ravi alustamisele järgneva depressiooni suhtes.
English: The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
Estonian: Patsiente, kelle HbA1c oli <7%, oli rimonabandi rühmas 51% ja platseeborühmas 35%.
English: Experience with rimonabant in overdosage is limited.
Estonian: Kogemused rimonabanti üleannustamise kohta on piiratud.
English: As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Estonian: Kehakaalu tõustes 65 kg-lt 200 kg-ni, väheneb Cmax eeldatavasti 24% ja Cthrough tõuseb eeldatavasti 5 %.
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).
Estonian: Väga sage (≥ 10 %), sage (≥ 1, < 10 %), aeg-ajalt (≥ 0,1, < 1 %), harv (≥ 0,01, < 0,1 %), väga harv (< 0,01 %), ei teata (ei ole eeldatav olemasolevate andmete alusel).
English: • Other psychiatric conditions
Estonian: ● Teised psühhiaatrilised seisundid
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.
Estonian: Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel http://www.emea.europa.eu/.
English: See leaflet for further information.
Estonian: Lugege infolehte täpsema informatsiooni saamiseks
English: Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/kg/day.
Estonian: Rimonabanti toimet pre- ja postnataalsele arengule hinnati rottidel annustega kuni 10 mg/kg/päevas.
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA.
Estonian: Võtke arstiga otsekohe ühendust, kui te ravi ajal ACOMPLIA'ga jääte rasedaks, arvate olevat rase või plaanite rasestuda.
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.
Estonian: Need olid tavaliselt kerge või mõõduka raskusastmega, paranesid vastava ravi tulemusel või rimonabanti manustamise katkestamisel ega erinenud millegi poolest juhtudest, mida tuvastati kontrollrühmades.
English: Do not use ACOMPLIA after the expiry date which is stated on the outer packaging after EXP.
Estonian: Ärge kasutage ACOMPLIA't pärast kõlblikkusaega, mis on märgitud välispakendil pärast Kõlblik kuni.
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.
Estonian: Populatsioonifarmakokineetika analüüsi põhjal (vanus 18…81 aastat) on üle 75-aastastel patsientidel Cmax 27 % kõrgem ja AUC 27 % kõrgem kui 40-aastastel.
English: Patients who received ACOMPLIA 20 mg for one year were re-randomized to ACOMPLIA 20 mg or placebo.
Estonian: Patsiendid, kes said ACOMPLIA 20 mg üks aasta randomiseeriti uuesti ACOMPLIA 20 mg või platseeborühma.
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.
Estonian: ACOMPLIA 20 mg ohutust hinnati ligikaudu 2500 patsiendil, kes osalesid kliinilistes uuringutes ainevahetusliku ja kehakaalu langetava toime uurimiseks ülekaalulisuse ja rasvumise korral, ja ligikaudu 3800 patsiendil muudel näidustustel.
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.
Estonian: Ainult ligikaudu 3 % manustatud rimonabanti annusest eritub uriiniga, samal ajal kui 86 % eritub roojaga muutumatult või metaboliitidena.
English: Weight management and additional risk factors
Estonian: Kehakaalu langetamine ja riskifaktorid
English: Pruritus Hyperhidrosis
Estonian: Sügelus Hüperhidroos
English: Table 1: System Organ Class
Estonian: Organsüsteemi klass
English: Table 2:
Estonian: Tabel 2
English: Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
Estonian: ACOMPLIA 20 mg ei avaldanud üldiselt märkimisväärset mõju üldkolesterooli või LDL kolesterooli sisaldusele.
English: In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days).
Estonian: Ühekordse annuse ja korduvmanustamise uuringutes olid rimonabanti Cmax ja AUC tervetel jaapanlastel ja europiidsest rassist isikutel sarnased, kuid eliminatsiooni poolväärtusaeg oli jaapanlastel lühem (3…4 päeva) kui kaukaaslastel (ligikaudu 9 päeva).
English: Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Estonian: Depressiivsed häired võivad olla seotud suitsidaalsete mõtete, enesevigastamise või enesetapu suurenenud ohuga.
English: Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
Estonian: Rimonabanti leiti lakteerivate rottide piimast ja rimonabant võib pärssida imemisrefleksi.
English: In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals.
Estonian: Mõningatel, kuid mitte kõigil juhtudel võis krampide teke olla seotud uuringuprotseduuridest tuleneva stressiga loomade käsitsemisel.
English: The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established.
Estonian: Rimonabanti efektiivsus ja ohutus üle 75 aasta vanuste patsientide ravis on lõplikult kindlaks tegemata.
English: Infections and infestations
Estonian: Infektsioonid ja infestatsioonid infektsioon
English: Patients, especially those with a history of depressive disorders/mood alterations, (and relatives or other relevant persons) should be alerted about the need to monitor for the emergence of such symptoms and to seek medical advice immediately if these occur.
Estonian: Patsiendid, ennekõike need, kel varasemalt on esinenud depressiivseid häireid/meeleolu kõikumisi (ning nende sugulased ja muud asjassepuutuvad isikud), peavad olema teadlikud vajadusest jälgida selliste sümptomite võimalikku ilmnemist ja nende tekkimisel pöörduma otsekohe arsti poole.
English: Following dosing for a longer treatment duration prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse effects were seen on fertility or oestrous cyclicity.
Estonian: Kui ravimit manustati pikemat aega (9 nädalat) enne paaritumist, mis võimaldas taastumist rimonabanti esialgsetest mõjudest, ei täheldatud kõrvaltoimeid fertiilsusele või hormonaalsele tsüklile.
English: Rimonabant, however, should be used with caution in these patients, see also section 5.3.
Estonian: Siiski peab rimonabanti nendel patsientidel kasutama ettevaatlikult, vt ka lõik 5.3.
English: Circulating metabolites do not contribute to its pharmacologic activity.
Estonian: Tsirkuleerivatel metaboliitidel ei ole farmakoloogilist toimet.
English: Important information about some of the ingredients of ACOMPLIA ACOMPLIA tablets include lactose.
Estonian: Oluline teave mõningate ACOMPLIA koostisainete suhtes ACOMPLIA tabletid sisaldavad laktoosi.
English: Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%).
Estonian: Ketokonasooli (CYP3A4 tugevatoimeline inhibiitor) samaaegsel manustamisel suurenes rimonabanti AUC 104 % (95 % ennustusvahemik 40 %…197 %).
English: If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
Estonian: Kui te ravi ajal ACOMPLIA'ga täheldate endal depressioonisümptomeid (vt allpool), peate võtma ühendust oma arstiga ja peatama ravi.
English: If you are intolerant to some sugars, contact your doctor before taking this medicine.
Estonian: Kui te ei talu teatud suhkruid, informeerige sellest oma arsti enne ravimi võtmist.
English: Gender: The pharmacokinetics of rimonabant are similar in female and male patients.
Estonian: Sugu Rimonabanti farmakokineetika on meestel ja naistel samasugune.
English: 5 How to store ACOMPLIA Further information
Estonian: 5 Kuidas ACOMPLIA't säilitada Lisainfo
English: Patients should notify their physician if they become pregnant during treatment with ACOMPLIA.
Estonian: Patsiendid peavad informeerima arsti rasestumisest ravi ajal ACOMPLIA'ga.
English: Joint sprain *frequency is based only on reports in obese or overweight diabetic patients.
Estonian: *esinemissagedus baseerub ainult rasvunud või ülekaaluliste diabeetiliste patsientide andmetel
English: In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies.
Estonian: 2. ja 3. faasi kliinilistes uuringutes osales 6800 patsienti.
English: Dysphoria Emotional disorder
Estonian: Düsfooria Emotsionaalsed häired
English: Administration of rimonabant to healthy subjects in the fasted state or with a high fat meal demonstrated that Cmax and AUC were increased 67% and 48% respectively, under fed conditions.
Estonian: Rimonabanti manustamine tervetele isikutele tühja kõhuga või koos kõrge rasvasisaldusega toiduga näitas, et täis kõhuga suurenes Cmax 67 % ja AUC 48 %.
English: Potential for rimonabant to affect other medicinal products:
Estonian: Rimonabanti võimalik mõju teistele ravimitele
English: In the limited number of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg).
Estonian: Piiratud arvul mustanahalistel patsientidel oli kaalulangus vähem väljendunud (keskmine erinevus platseebost -2,9 kg).
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.
Estonian: Rasvunud patsientidel on suuremast jaotusruumalast tulenevalt eliminatsiooni poolväärtusaeg pikem (ligikaudu 16 päeva) kui mitterasvunud patsientidel (ligikaudu 9 päeva).
English: The apparent peripheral volume of distribution of rimonabant appears to be related to body weight, with obese patients having a higher volume of distribution than normal-weight subjects.
Estonian: Rimonabanti perifeerne jaotusruumala näib olevat sõltuvuses kehakaalust, olles rasvunud patsientidel suurem kui normaalkaalulistel isikutel.
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%).
Estonian: Alljärgnev tabel (tabel 1) näitab kõiki raviga seotud kõrvaltoimeid platseebo-kontrollitud uuringutes osalenud patsientidel, keda raviti kehakaalu vähendamiseks ja ülekaalulisega seotud metaboolsete häirete tõttu, kui nende kõrvaltoimete esinemissagedus ületas olulisel määral platseeborühma oma (juhtumid esinemissagedusega ≥ 1 %) või neid peeti kliiniliselt olulisteks (juhtumid esinemissagedusega < 1 %).
English: Irritability Nervousness Sleep disorders Insomnia Parasomnias
Estonian: Ärrituvus Närvilisus Unehäired Insomnia Parasomnia
English: The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Estonian: Poolväärtusaja erinevus oli tingitud jaapanlaste madalamast kehakaalust tingitud väiksemas jaotusruumalas.
English: Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Estonian: Piiratud andmed viitavad süsteemse saadavuse suurenemisele (AUC suurenemine 40 %) mõõduka neerukahjustusega patsientidel.
English: − Nervous disorders: convulsions, disturbance in attention, headache.
Estonian: - närvisüsteemi häired: krambid, tähelepanu häired, peavalu.
English: The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended.
Estonian: Rimonabanti farmakokineetikat ja ohutust ei ole uuritud tõsise maksakahjustusega patsientidel, mistõttu seda ei soovitata nendele patsientidele.
English: However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
Estonian: In vitro oli rimonabantil siiski vähene pärssiv toime CYP2C8 suhtes.
English: A direct effect of rimonabant cannot be ruled out.
Estonian: Rimonabanti otsest toimet ei saa välistada.
English: Population pharmacokinetic analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke.
Estonian: Populatsioonifarmakokineetika analüüs näitas, et rimonabanti farmakokineetika tervetel mittesuitsetajatel ei erine suitsetavate patsientide omast.
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).
Estonian: Reproduktiivsusnäitajate osas ei täheldatud erinevusi ravimit annuses 30 mg/kg saanud loomade ja kontrollisendite vahel, annuse korral 60 mg/kg olid erinevused endiselt täheldatavad (kollakeha, implantatsioonide, loodete üldarvu ja elujõuliste loodete arvu vähenemine).
English: Lethargy Tremor
Estonian: Letargia Treemor
English: Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo.
Estonian: Rimonabant on selektiivne kannabinoid-1 retseptori (KB-1) antagonist, mis pärsib kannabinoidagonistide farmakoloogilisi toimeid in vitro ja in vivo.
English: Name and address of the manufacturers responsible for batch release Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Prantsusmaa sanofi-aventis S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Itaalia Ravimi trükitud pakendi infolehel peab olema vastava ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress
English: Time to steady state is longer in obese patients (25 days) as a consequence of the higher volume of distribution in these patients.
Estonian: Rasvunud patsientidel kulub püsitasakaalu kontsentratsiooni saavutamiseks kauem aega (25 päeva) tulenevalt nende patsientide suuremast jaotusruumalast.
English: Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
Estonian: Kliinilise farmakoloogia uuringutes saadud kogemused näitavad, et rimonabantil puudub märkimisväärne kognitiivne või sedatiivne mõju.
English: Rimonabant has not been studied in patients being treated for epilepsy.
Estonian: Rimonabanti ei ole uuritud epilepsia ravi saavatel patsientidel.