natgillin/translations-raw huggingface dataset:
Time to steady state is longer in obese patients (25 days) as a consequence of the higher volume of distribution in these patients.
Čas do stanja dinamičnega ravnovesja je pri debelih bolnikih daljši (25 dni), ker je volumen porazdelitve pri njih večji.
The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.
Najpogostejši neželeni učinki, ki so povzročili prekinitev, so bili: navzeja, spremembe razpoloženja z depresivnimi simptomi, depresivne motnje, anksioznost in omotica.
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.
Zdi se, da je navidezni periferni volumen porazdelitve rimonabanta povezan s telesno maso; debeli bolniki imajo večji volumen porazdelitve kot preiskovanci z normalno telesno maso.
− ritonavir (medicine for the treatment of HIV infections)
− ritonavir (zdravilo za zdravljenje okužbe s HIV),
A direct effect of rimonabant cannot be ruled out.
Neposrednega učinka rimonabanta ni mogoče izključiti.
The endocannabinoid system is a physiological system present in brain and peripheral tissues (including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods.
Endokanabinoidni sistem je fiziološki sistem v možganih in perifernih tkivih (vključno z adipociti), ki vpliva na ravnovesje energije, presnovo glukoze in lipidov ter na telesno maso in ki v nevronih mezolimbičnega sistema modulira vnos zelo okusne, sladke ali mastne hrane.
Laboratory adverse events ACOMPLIA has not been shown to alter laboratory test values.
Laboratorijski neželeni učinki Ni ugotovljeno, da bi ACOMPLIA spreminjala vrednosti laboratorijskih testov.
Data are insufficient to draw conclusions regarding pharmacokinetics in moderate hepatic impairment.
Podatkov ni dovolj za sklepanje o farmakokinetiki pri zmerni okvari jeter.
− metabolism and nutrition disorders: anorexia, decreased appetite,
− presnovne in prehranske motnje: anoreksija, zmanjšanje apetita
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Imetnik dovoljenja za promet mora zagotoviti vzpostavljen sistem vodenja farmakovigilance, ki mora delovati že pred prihodom zdravila na trg.
− if you are currently being treated for depression
− če se trenutno zdravite zaradi depresije
− nefazodone (anti-depressor)
− nefazodon (antidepresiv).
There was a treatment related increase in pup mortality in the pre-weaning period.
Opažena je bila večja s terapijo povezana umrljivost mladičev podgan v obdobju pred odstavitvijo.
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.
Uporaba rimonabanta pri zdravih preiskovancih na tešče ali z zelo mastnim obrokom je pokazala, da je bila Cmax na poln želodec večja za 67 % in AUC za 48 %.
• Race
• Rasa
You need to start and continue a reduced calorie diet and a physical activity program to get best results.
Da boste dosegli najboljše uspehe, morate začeti in vzdrževati manj kalorično dieto in program telesne dejavnosti.
No convulsions were observed in dogs during a 3 month study.
Med 3-mesečno študijo na psih konvulzij niso zabeležili.
This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure (see section 5.2).
Vzrok tega bi lahko bil večji očistek rimonabanta pri črncih kot pri belcih s posledično manjšo izpostavljenostjo (glejte poglavje 5.2).
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.
Bolnike, še posebej tiste, ki so kdaj imeli depresivno/razpoloženjsko motnjo (in njihove sorodnike ali druge osebe, ki za njih skrbijo) je treba opozoriti, da morajo biti pozorni na pojav tovrstnih simptomov.
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.
Po dolgotrajnejši uporabi pred parjenjem (9 tednov), ki je omogočila okrevanje po uvodnih vplivih rimonabanta, niso ugotovili neželenih učinkov na plodnost in cikličnost estrusa.
Potential for other medicinal products to affect rimonabant:
Možnost vpliva drugih zdravil na rimonabant:
If you are intolerant to some sugars, contact your doctor before taking this medicine.
Če ne prenesete nekaterih sladkorjev, se morate pred jemanjem tega zdravila posvetovati z zdravnikom.
The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of rimonabant in milk and/or inhibition of the suckling reflex that is reported in the literature to be initiated in neonatal mice by endocannabinoid signalling via CB1 receptors.
Večjo umrljivost mladičev podgan je morda mogoče pripisati nezmožnosti samic za dojenje ali pa zaužitju rimonabanta z mlekom in/ali zavrtju sesalnega refleksa, za katerega je v literaturi opisano, da ga pri novoskotenih miših sproži endokanabinoidni prenos prek receptorjev CB1.
Monitoring of blood glucose level is recommended in these patients.
Pri teh bolnikih je priporočljiv nadzor sladkorja v krvi.
Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01
Farmakoterapevtska skupina: Zaviralci apetita, brez dietnih pripravkov Oznaka ATC: A08AX01
Tablet polishing: carnauba wax (E903)
Glazura tablete: karnauba vosek (E903)
Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy.
Sočasna uporaba induktorjev CYP3A4 (npr. rifampicina, fenitoina, fenobarbitala, karbamazepina, šentjanževke) sicer ni raziskana, a pričakovati je, da lahko sočasna uporaba močnih induktorjev CYP3A4 zmanjša koncentracijo rimonabanta v plazmi in tako zmanjša njegovo učinkovitost.
Subjects with a 10% weight reduction Difference (CI 95%)
preiskovanci z 10 % zmanjšanjem telesne mase razlika (IZ95 %)
ACOMPLIA is contraindicated during breast-feeding (see section 4.3).
ACOMPLIA je kontraindicirana med obdobjem dojenja (glejte poglavje 4.3).
If you take more ACOMPLIA than you should If you take more ACOMPLIA than you should tell a doctor or pharmacist.
Če ste vzeli večji odmerek zdravila ACOMPLIA, kot bi smeli Če ste vzeli večji odmerek zdravila ACOMPLIA, kot bi smeli, morate to povedati zdravniku ali farmacevtu.
Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
Na splošno ACOMPLIA 20 mg ni pomembno vplivala na koncentracijo celotnega holesterola ali holesterola LDL.
The potential for inhibition of CYP2C8 in vivo appears to be low.
Kaže, da je potencial za zavrtje CYP2C8 in vivo majhen.
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA include: hallucinations.
Redki neželeni učinki, ki se pojavijo pri manj kot 1 od 1000 oseb in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ACOMPLIA, vključujejo: halucinacije.
The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended.
Farmakokinetika in varnost rimonabanta nista raziskani pri bolnikih s hudo okvaro jeter; uporaba zdravila pri teh bolnikih zato ni priporočljiva.
Potential for rimonabant to affect other medicinal products:
Možnost vpliva rimonabanta na druga zdravila:
Experience with rimonabant in overdosage is limited.
Izkušnje s prevelikim odmerjanjem rimonabanta so omejene.
The tablets contain approx. 115 mg lactose.
Tablete vsebujejo približno 115 mg laktoze.
Circulating metabolites do not contribute to its pharmacologic activity.
Presnovki v obtoku ne prispevajo k njegovemu farmakološkemu delovanju.
• Lactose
• Laktoza
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
Rimonabant so našli v mleku doječih podgan in zdravilo lahko zavre sesalni refleks.
In clinical studies for other indications, the following additional adverse reactions were commonly reported:
V kliničnih študijah pri drugih indikacijah so bili pogosto opisani naslednji dodatni neželeni učinki:
Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St John's wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or depression.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, npr. šentjanževko, rifampicin (antibiotik), zdravila za hujšanje, zdravila za izboljšanje lipidov (maščob) v krvi, zdravila proti diabetesu, zdravila proti epilepsiji (npr. fenitoin, fenobarbital, karbamazepin) ali zdravila proti depresiji.
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.
Sočasna uporaba orlistata, etanola ali lorazepama ni pomembno vplivala na koncentracijo rimonabanta v plazmi.
If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
Če se med zdravljenjem z zdravilom ACOMPLIA pojavijo simptomi depresije (glejte spodaj), zdravilo ACOMPLIA prenehajte jemati in se posvetujte s svojim zdravnikom.
− if you have severely impaired renal function
− če imate zelo okvarjeno delovanje ledvic,
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.
(ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Francija sanofi-aventis S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italija V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Navodilo je bilo odobreno "Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu/."
ACOMPLIA 20 mg nITT
ACOMPLIA 20 mg nZNZ
Asthenia/fatigue Influenza
Splošne težave astenija/ utrujenost gripa
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA.
Če med jemanjem zdravila ACOMPLIA zanosite, sumite, da ste zanosili, ali načrtujete nosečnost, se morate takoj posvetovati z zdravnikom.
Population pharmacokinetic analysis demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
Analiza populacijske farmakokinetike ob povečevanju telesne mase je pokazala manj nihanja v razmerju med najvišjo in najnižjo koncentracijo v plazmi, a nobenih razlik v AUC v stanju dinamičnega ravnovesja.
Experience in patients over 75 years and Orientals/Asians was limited.
Ni dovolj zkušenj pri bolnikih, starejših od 75 let in pri osebah orientalskega/azijskega porekla.
The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically.
Učinek delovanja ledvic na farmakokinetiko rimonabanta ni posebej raziskan.
In the pre- and post-natal development study in rats, exposure to rimonabant in utero and via lactation produced no alterations on learning or memory, but equivocal effects on motor activity and auditory startle response were observed in the pups as a result of rimonabant exposure.
V študiji pre- in postnatalnega razvoja pri podganah izpostavljenost rimonabantu in utero prek dojenja ni povzročila sprememb pri učenju ali pomnjenju, so pa pri mladičih podgan kot posledico izpostavljenosti rimonabantu opažali nejasne učinke na motorično delovanje in zdrznitev na slušni dražljaj.
Do not take this medicine when breast-feeding.
Ne jemljite tega zdravila, če dojite.
No conclusions can be drawn with regard to effects in patients over 75 years or in Asian/Oriental patients due to the low number of patients.
Zaradi majhnega števila bolnikov ni mogoče sklepati o učinkih pri bolnikih, starejših od 75 let, in pri bolnikih azijskega/orientalskega porekla.
In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that induced maternal toxicity (30 and 60 mg/kg/day).
V standardnih študijah plodnosti na podganjih samicah (uporaba zdravila 2 tedna pred parjenjem) so ugotovili nenormalno cikličnost estrusa ter zmanjšanje rumenih telesc in indeksa plodnosti ob odmerkih rimonabanta, ki so povzročili toksične učinke pri samicah-materah (30 in 60 mg/kg/dan).
During post-marketing experience the following side effects have also been reported (frequency not known):
Po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih (pogostnost neznana):
The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
Klinični učinek (zmanjšanje telesne mase) rimonabanta je bil pri črncih manjši kot pri belcih.
As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
Kot dodatek k dieti in telesni dejavnosti za zdravljenje debelih bolnikov (ITM ≥ 30 kg/m2), ali bolnikov s čezmerno telesno maso (ITM > 27 kg/m2) z enim ali dvema spremljajočima dejavnikoma tveganja, kot sta diabetes tipa 2 ali dislipidemija (glejte poglavje 5.1).
Due to the effect of rimonabant on the blood glucose level, when rimonabant is administered in diabetic patients, hypoglyceamia can occur (see section 4.8).
Zaradi učinka rimonabanta na koncentracijo sladkorja v krvi, se lahko pri bolnikih s sladkorno boleznijo po zaužitju rimonabanta pojavi hipoglikemija (glejte poglavje 4.8).
Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ACOMPLIA include: upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.
Pogosti neželeni učinki, ki se pojavijo pri več kot 1 od 100, a manj kot 1 od 10 oseb, in so bili zabeleženi pri bolnikih, ki so jemali zdravilo ACOMPLIA, vključujejo: razdražen želodec, bruhanje, težave s spanjem, živčnost, depresijo, razdražljivost, omotico, drisko, tesnobnost, srbenje, čezmerno znojenje, mišične krče ali spazme, utrujenost, podplutbe, bolečine in vnetje tetiv (tendinitis), poslabšanje spomina, bolečino v hrbtu (išias), spremenjeno zaznavanje (manjša občutljivost ali nenormalen pekoč občutek ali mravljinčenje) v dlaneh in stopalih, valove vročine, padec, gripo in izvin sklepov.
What ACOMPLIA looks like and contents of the pack ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Izgled zdravila ACOMPLIA in vsebina pakiranja ACOMPLIA 20 mg so bele filmsko obložene tablete v obliki solze, ki imajo na eni strani vtisnjeno oznako "20".
In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with metformin or sulfonylurea improvements in HbA1c and body weight were observed.
V preskušanju pri pretežkih ali debelih diabetikih tipa 2 (RIO - Diabetes), ki so dobivali metformin ali sulfonilsečnino, so ugotovili izboljšanje HbA1c in telesne mase.
Mild hepatic impairment does not alter rimonabant exposure.
Blaga okvara jeter ne spremeni izpostavljenosti rimonabantu.
France sanofi-aventis S.p.A. Strada Statale 17, Km 22 67019 Scoppito (AQ) Italy
Strada Statale 17, Km 22 67019 Scoppito (AQ) Italija
If you have any further questions on the use of this product ask your doctor or your pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Steady state rimonabant exposures are 3.3-fold higher than those observed after the first dose.
Izpostavljenost rimonabantu v stanju dinamičnega ravnovesja je 3,3-krat večja kot po prvem odmerku.
Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8).
Pri do 10 % bolnikov, ki so se zdravili z rimonabantom, so poročali o depresivnih motnjah ali spremembah razpoloženja s simptomi depresije, pri do 1 % bolnikov pa o pojavu samomorilnih misli (glejte poglavje 4.8).
− clarithromycin (antibiotic)
− klaritromicin (antibiotik),
Do not take ACOMPLIA
Ne uporabljajte zdravila ACOMPLIA
ACOMPLIA is indicated in the treatment of obese or overweight patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise.
Zdravilo ACOMPLIA je namenjeno za zdravljenje debelih ali bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja, kot sta diabetes ali povišane vrednosti maščob v krvi - t. i. lipidi (dislipidemija; predvsem holesterol in trigliceridi) kot dopolnilo k dieti in telesni dejavnosti.
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.
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.
The in vivo inhibitory effect on CYP2C8 has not been studied.
Zaviralni učinek na CYP2C8 in vivo ni raziskan.
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.
V literaturi je opisano, da se prostorska porazdelitev in gostota receptorjev CB1 v možganih med razvojem spreminjata tako pri glodalcih kot pri človeku.
The usual dose is one 20 mg tablet to be taken once daily in the morning before breakfast.
Običajni odmerek je ena 20 mg tableta; vzeti ga morate enkrat na dan, zjutraj pred zajtrkom.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/344/007
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/06/344/007
Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.
Bikonveksne bele tablete v obliki solze z vtisnjeno oznako "20" na eni strani.
Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Obloga tablete: laktoza monohidrat, hipromeloza 15 mPa.s (E464), titanov dioksid (E171), makrogol 3000
Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Rimonabant in vitro ne zavira in ne inducira drugih encimov CYP ali P-glikoproteina (P-gp).
− if you currently suffer from depression
− če imate depresijo
The absolute bioavailability of rimonabant has not been determined.
Absolutna biološka uporabnost rimonabanta ni ugotovljena.
HOW TO TAKE ACOMPLIA
KAKO JEMATI ZDRAVILO ACOMPLIA
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).
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).
These included headache, euphoria, fatigue and insomnia.
Ob tem so zabeležili le manj pomembne simptome, med katerimi so bili glavobol, evforija, utrujenost in nespečnost.
Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant.
Glede na podatke študij populacijske farmakokinetike blaga okvara ledvic ne vplivata na farmakokinetiko rimonabanta.
Patients with hepatic insufficiency:
Bolniki z insuficienco jeter:
- 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.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
− infections and infestations: sinusitis
− infekcijske in parazitske bolezni: sinuzitis,
Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Rimonabant ima in vitro veliko permeabilnost in ni substrat P-glikoproteina.
Paediatrics:
Pediatrični bolniki:
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Zaradi pomanjkanja podatkov o učinkovitosti in varnosti uporaba zdravila ACOMPLIA pri otrocih pod 18 let ni priporočljiva.
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:
V kliničnih študijah niso opazili škodljivih reakcij, v študijah na živalih pa so jih opazili pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti.
ACOMPLIA should be used with caution in patients over 75 years of age (see section 4.4).
Pri bolnikih, starejših od 75 let, zdravilo ACOMPLIA uporabljajte previdno (glejte poglavje 4.4).
− telithromycin (antibiotic)
− telitromicin (antibiotik),
Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant.
Pričakovati je mogoče, da sočasna uporaba induktorjev CYP3A4 zmanjša izpostavljenost rimonabantu.
In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
Med bolniki, ki so dobivali rimonabant v študijah, kontroliranih s placebom, je bil delež prekinitev zaradi neželenih reakcij 15,7%.
If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Če se med terapijo z rimonabantom diagnosticira depresija, se mora zdravljenje končati.
Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant.
Sočasna uporaba zaviralcev CYP3A4 poveča izpostavljenost rimonabantu.
Increased incidence and/or severity of clinical signs suggestive of increased tactile hyperesthesia were observed in rodent studies.
V študijah na glodalcih so ugotovili večjo incidenco in/ali izrazitost kliničnih znakov, ki nakazujejo povečano taktilno hiperestezijo.