natgillin/translations-raw huggingface dataset:
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of
Kognitive undersøgelser i klinisk farmakologiske forsøg viste, at rimonabant er blottet for kognitiv eller sedativ effekt.
d any significant cognitive or sedative effect.
tor 4. 8 Bivirkninger
ise 4.8 Undesirable effects
2500 patienter i forsøg som undersøgte effekten på metabolisme og vægttab hos overvægtige og stærkt overvægtige patienter og hos ca.
or uth ZIMULTI 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.
3800 patienter i andre indikationer.
In placebo-controlled studies, the discontinuation rate due to
I placebokontrollerede forsøg var frekvensen af afbrudt behandling, pga. ere bivirkninger, 15, 7% for patienter, der fik rimonabant.
ra adverse reactions was 15.7% for patients receiving rimonabant.
De mest almindelige bivirkninger, som førte til afbrudt behandling var: kvalme, humørsvingninger med depressive symptomer, depressive sygdomme, uro og svimmelhed. ng
The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive ge disorders, anxiety and dizziness. on
Disse var sædvanligvis milde eller læ
These were usually mild or moderate in severity and ol
Korrektiv behandling eller afbrydelse af rimonabant resulterede i helbredelse i alle tilfælde og behandlingen udviste ingen forskelle sammenlignet med tilfælde rapporteret i kontrolgruppen.
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. tn uc
Den følgende tabel (Tabel 1) viser alle behandlingsrelaterede bivirkninger fra 4 placebokontrollerede ke
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 d
forsøg med patienter, som blev behandlet for vægttab og relaterede metaboliske sygdomme, når forekomsten var statistisk signifikant større end den tilsvarende placebofrekvens (for tilfælde ≥ 1%) r ik
statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered ro
eller når den blev betragtet som klinisk relevant (for tilfælde < 1%).
clinically relevant (for events < 1%). lp
Meget almindelig (≥ 10%); Almindelig (≥ 1, < 10%); Usædvanlig (≥ 0, 1, < 1%); Sjælden (≥ 0, 01, < te
Very common (≥ 10%); Common (≥ 1, < 10%); Uncommon (≥ 0.1, < 1%); Rare (≥ 0.01, < 0.1%); Very ina
0, 1%); Meget sjælden (< 0, 01%), ikke kendt (kan ikke estimeres ud fra de forhåndenværende data). dle
rare (< 0.01%), Not known (cannot be estimated from the available data). dic
De alvorligste bivirkninger skal anføres først. mi ge Læ
Me
Organ- klasse system Infektioner og parasitære sygdomme
System Organ Class
Almindelig Gastroenteritis
Very common
lg Metabolisme og ernæring
Rare
Hypoglykæmi *
Infections infestations Metabolism and
Psykiske forstyrrelser
and Upper respiratory Gastroenteritis tract infection
Depressive
Hypoglycaemia*
Paniksymptomer
nutrition disorders
Hallucinationer
Psychiatric disorders
sygdomme
Depressive disorders
Vrede
Panic symptoms Anger
Humørsvingninger med depressive
Hallucinations
Dysphoria Følelses -
Mood alterations Dysphoria
symptomer Angst
with depressive symptoms Anxiety Irritability
forstyrrelser Selvmordstanker
Emotional disorder Suicidal ideation Aggressiveness
ret
d ise
Irritabilitet Nervøsitet Søvnforstyrrelser
Nervousness Sleep disorders Insomnia
Aggressivitet Aggressiv adfærd
Aggressive behaviour
Hukommelsestab
or Parasomnias
tor
uth Nervous system disorders
Svimmelhed Hypoaesthesia Ischias
Memory loss Dizziness Hypoaesthesia Sciatica
Rødme au Paræstesi
Paresthesia ge
ere Luftveje, thorax og mediastinum
ra
Hikke
Vascular disorders Respiratory,
Mave- tarmkanalen
Hot flush on
Kvalme
thoracic and
ng
ol
Diarré Opkastning
mediastinal disorders tn
læ
Nausea
Pruritus Hyperhidrosis
uc
Nattesved
Diarrhoea Vomiting
Knogler, led, muskler og bindevæv
Skin and subcutaneous tissue
ke
d
Tendonitis Muskelkramper Muskelspasmer
Pruritus Hyperhidrosis
Almene symptomer
Night sweats
Slaphed/ træthed Influenza
disorders ro
Traumer, forgiftninger og
Musculoskeletal
Fald
Tendonitis
behandlingskomplikationer
and Muscle cramp connective
Blå mærker Ledforstuvning
ina
* frekvens er kun baseret på rapporter på obese eller overvægtige personer. te
Muscle spasms
- Infektioner og parasitære sygdomme: sinusitis
tissue disorders General disorders
- Mave- tarmkanalen: ondt i maven, tør mund.
Asthenia/ fatigue Influenza
Efter markedsføring Følgende bivirkninger er yderligere rapporteret efter markedsføring (hyppighed ikke kendt):
Injury, Poisoning and procedural Me
Læ
Fall Contusion
-
complications
Psykiske forstyrrelser: psykotiske tilstande inklusive hallucinationer, vrangforestillinger
Joint sprain
og paranoia.
*frequency is based only on reports in obese or overweight diabetic patients.
- - -
In clinical studies for other indications, the following additional adverse reactions were commonly reported: − infections and infestations: sinusitis − metabolism and nutrition disorders: anorexia, decreased appetite, − gastrointestinal disorders: stomach discomfort, dry mouth.
Mave- tarm kanalen: mavesmerter.
6 Post-Marketing In addition the following adverse reactions were reported during postmarketing (frequency not known): − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia. − Skin and subcutaneous tissue disorders: rash. − Nervous disorders: convulsions, disturbance in attention, headache. − gastrointestinal disorders: abdominal pain.
6 Laboratorie bivirkninger ZIMULTI har ikke vist påvirkning af laboratorietestværdier.
Laboratory adverse events ZIMULTI has not been shown to alter laboratory test values.
lg Erfaring med overdosering af rimonabant er begrænset.
Experience with rimonabant in overdosage is limited.
I et enkeltdosis toleranceforsøg, blev doser på op til 300 mg givet til et begrænset antal forsøgspersoner.
d 300 mg were administered to a limited number of subjects with only minor symptoms reported.
Ved forsøget blev der rapporteret svage
These
Disse inkluderede hovedpine, eufori, træthed og insomnia.
ise included headache, euphoria, fatigue and insomnia.
Behandling bør bestå
Treatment should consist of
til af generelle principper anvendt ved behandling af overdosis, såsom at holde luftvejene fri, monitorering af kardiovaskulær funktion og generelle og supportive målinger.
or the general measures employed in the management of overdoses, such as keeping airways
FARMAKOLOGISKE EGENSKABER
uth unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.
ise 5. 1 Farmakodynamiske egenskaber
PHARMACOLOGICAL PROPERTIES ra ge 5.1 Pharmacodynamic properties on
tor Farmakoterapeutisk klassifikation:
Pharmaco-therapeutic group:
Antiobesitas middel ATC- kode:
Anti obesity agent ol
A08AX01
A08AX01 tn
effekt af cannabinoid agonister in vitro og in vivo.
Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo. uc
Rimonabant er en selektiv cannabinoid- 1 receptor (CB1) antagonist som hæmmer den farmakologiske
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 d
Systemet har effekt på energibalance, glukose, lipidmetabolisme og kropsvægt.
in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods. ro
Resultater i kliniske forsøg læ
Clinical study results lp ina
Patienterne inkluderet i fase 3 forsøgene fulgte en restriktiv diæt under forsøget ordineret af en diætist og de blev rådet til at ke
The patients dic
forøge deres fysiske aktivitet.
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.
Patienterne havde et BMI ≥ 30 kg/ m2 eller BMI > 27 kg/ m2 med hypertension og/ eller dyslipaedimia ved inklusionen.
Patients had a BMI ≥ 30 kg/ m² or BMI > 27 kg/ m² Me
kaukasier og 9% negroide.
Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Erfaring med patienter over 75 år og orientalere/ asiater er begrænset.
Experience in patients over 75 years and Orientals/ Asians was limited.
Signifikant middelvægtreduktion fra baseline til et år for ZIMULTI 20 mg versus placebo blev te
Significant mean weight reductions from baseline to one year for ZIMULTI 20 mg versus placebo were demonstrated in three studies conducted in non-diabetic patients.
Et middel vægttab på 6, 5 kg fra baseline til et år blev vist for ZIMULTI 20 mg versus et middelvægttab på 1, 6 kg for placebo (forskel - 4, 9 kg CI95% - 5, 3; - 4, 4, p < 0, 001). dle
A mean weight loss of 6.5 kg from baseline to one year was shown for ZIMULTI 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3; -4.4, p < 0.001).
Procentdelen af patienter som tabte 5% og 10% af deres baseline kropsvægt efter 1 års behandling er vist i Tabel 2: mi ge Læ
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in table 2:
ZIMULTI Placebo 20 mg
Placebo ZIMULTI 20 mg
lg nITT
nITT
sa Vægt ved baseline (kg)
Weight at baseline (kg)
Personer med 5%
Subjects with a 5% weight reduction
ret Forskel (CI 95%)
Difference (CI 95%)
Personer med 10%
Subjects with a 10% 7.8% weight reduction
tor Det meste af den observerede vægtreduktion blev set inden for de første 9 måneders behandling.
ise or Most of the observed weight reduction was obtained within the first nine months of treatment.
ZIMULTI 20 mg var effektiv til at vedligeholde vægttab i op til 2 år.
uth ZIMULTI 20 mg was effective in maintaining weight loss up to two years.
Vægttab ved 2 år var 5, 1 kg for patienter, der fik ZIMULTI 20 mg og 1, 2 kg for placebo (forskel – 3, 8 kg; CI95 - 4, 4, - 3, 3; p < 0, 001).
Weight loss at two years was 5.1 kg for patients who received ZIMULTI 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p < 0.001).
au Rimonabant 20 mg reducerede risikoen for vægtforøgelse.
ra Rimonabant 20 mg reduced the risk of weight regain.
Patienter, der fik ZIMULTI 20 mg, blev re - randomiseret til at få ZIMULTI 20 mg eller placebo.
Patients who received ZIMULTI 20 mg for one ge year were re-randomized to ZIMULTI 20 mg or placebo.
Ved 2 år havde patienter, der fortsatte på ere rimonabant, et gennemsnitlig totalt vægttab på 7, 5 kg over de 2 år, mens patienter, der blev re - randomiseret til placebogruppen i det andet år, havde et gennemsnitligt totalt vægttab på 3, 1 kg over de 2 år.
At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to on
Ved 2 år var forskellen i totalt vægttab mellem ZIMULTI og placebogruppen - 4, 2 kg (CI95 - 5, 0; - 3, 4, p < 0, 001). ng
At two years, the difference in total weight loss between ZIMULTI and placebo was -4.2 kg (CI95% -5.0; -3.4, ol
Behandling med rimonabant var associeret med en signifikant reduktion i livsmål, en kendt markør for læ
Treatment with rimonabant was associated with significant reductions in waist circumference, a uc
intra- abdominalt fedt.
known marker of intra-abdominal fat. d
Der kan ikke drages ke
In the limited number ro
nogle konklusioner vedrørende effekt for patienter over 75 år eller for asiater/ orientalere p. g. a. af det lave antal patienter. r ik
No conclusions can be drawn with regard to effects in patients over 75 years or in Asian/ Oriental patients lp
Vægtstyring og yderligere risikofaktorer te
due to the low number of patients. ina
I ikke- diabetesforsøgene med en blandet population af personer med/ uden (behandlet) dyslipidemia blev en forøgelse i HDL- C og et fald i triglycerider observeret (efter et år).
dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed.
En middelforøgelse for HDL- C på 16, 4% blev set for rimonabant 20 mg (baseline HDL- C 1, 24 mmol/ l) sammenlignet med dle
For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 Me
en forøgelse på 8, 9% for placebo (baseline HDL- C 1, 21 mmol/ l).
mmol/ l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/ l).
Forskellen var statistisk signifikant (forskel 7, 9% CI95 6, 6%; 9, 2%, p < 0, 001).
The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p < 0.001).
For triglycerider blev der set et middelfald på 6, 9% ved rimonabant 20 mg (baseline TG 1, 62 mmol/ l) sammenlignet med en forøgelse på 5, 8% for placebo mi
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).
Det estimeres at ca. halvdelen af den observerede forbedring i HDL- C og triglyserider hos patienter, der fik rimonabant 20 mg var ud over det, der forventedes fra vægttab alene. ge
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.
ZIMULTI 20 mg havde generelt ingen signifikant effekt på Total- C eller LDL- C niveauer.
Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Diabetes) behandlet med metformin eller sulfonylurea, som var overvægtige eller obese.
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.
8 Efter et år så man et middelvægttab på 5, 3 kg for ZIMULTI 20 mg versus et tab ved placebo på 1, 4 kg (forskel - 3, 9 kg CI95% - 4, 6; - 3, 3, p < 0, 001).
8 At one year a mean weight loss of 5.3 kg was shown for ZIMULTI 20 mg versus a loss on placebo of 1.4 kg (Difference – 3.9 kg CI95% -4.6; -3.3 p < 0.001).
Procentdelen af patienter, som opnåede
In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p < 0.001).
sa HbA1c < 7%, var 51% i rimonabant- gruppen og 35% i placebo- gruppen.
The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
Forskellen mellem 20 mg - og placebo- gruppen, i den gennemsnitlige ændring af kropsvægt, var 3, 8 kg (CI95% - 5, 0, - 2, 6 p < 0, 001).
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).
til Det estimeres, at ca. halvdelen af middelforbedringen i HbA1c hos patienter, der fik rimonabant 20 mg var ud over den forventede effekt på vægttabet alene.
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.
ret 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
ise Farmakokinetikken for rimonabant er forholdsvis proportional op til 20 mg.
AUC increased less than
For doser over 20 mg forøgedes AUC mindre end proportionalt.
d in proportion to dose above 20 mg.
tor Absorption:
ise Absorption:
Rimonabant viser høj in vitro permeabilitet og er ikke et substrat af P- glycoprotein.
The absolute
Den absolutte biotilgængelighed for rimonabant er ikke bestemt.
uth bioavailability of rimonabant has not been determined.
Efter mange doser af 20 mg givet en gang dagligt til
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
2 timer med et steady state plasmaniveau opnået efter 13 dage (Cmax = 196 + 28, 1 ng/ ml; Cmin = 91, 6 + 14, 1 ng/ ml; AUC0- 24 = 2960 + 268 ng. h/ ml).
ra ng/ ml; Ctrough = 91.6 ± 14.1 ng/ ml; AUC0-24 = 2960 ± 268 ng. h/ ml).
Steady state rimonabant eksponering er 3, 3 gange højere end det ere observerede efter første dosis.
Steady state rimonabant exposures are 3.3-fold higher than those observed after the first dose.
Farmakokinetisk populationsanalyse viste mindre udsving i max. til min. plasmakoncentration, men ingen forskel i steady state AUC, som vægten øges.
Population pharmacokinetic analysis ge demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
Som vægten forøges fra 65 kg til 200 kg, forventes Cmax at falde 24% og Cmin forventes at forøges med 5%.
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% on
Tiden til steady state er længere hos obese patienter (25 dage) som en konsekvens af det højere ng
Time to steady state is longer in obese patients (25 days) as a consequence of the higher volume of distribution in these patients.
Farmakokinetiske populationsanalyser indikerer, at rimonabants farmakokinetik er den samme for sunde, ikke- rygende personer og patienter som ryger. læ
analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke. tn uc
Administration af rimonabant til sunde fastende personer eller med et meget fedt måltid, viste at Cmax og AUC forøgedes henholdsvis 67% og 48% ved fedt måltid.
In ro
ZIMULTI 20 mg blev taget om ke
clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast. lp
In vitro human plasmaproteinbinding af rimonabant er høj (> 99, 9%) og ikke- mættet over et stort koncentrationsområde.
The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a ina
Det tilsyneladende perifere distributionsvolume for rimonabant synes at være relateret til kropsvægt, hvor obese patienter har et højere distributionsvolume end personer med te
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 dic
normal vægt. dle
Me
Cirkulerende metabolitter bidrager ikke til den farmakologiske aktivitet. mi
Circulating metabolites do not contribute to its pharmacologic activity.
Rimonabant bliver hovedsageligt elimeneret via metabolisme og efterfølgende udskillelse af ge
Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites.
Kun omkring 3% af rimonabant- dosis bliver elimineret via urinen, mens omkring 86% af dosis udskilles i fæces som uomdannet stof og metabolitter.
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.
9 dage) p. g. a. af et Læ
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.
Race:
9 Special Populations Race:
I enkelt - og gentagen- dosisforsøg var Cmax og AUC for rimonabant ens hos sunde japanske og kaukasiske personer, men eliminationshalveringstiden var kortere hos japanske personer (3- 4 dage)
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).
Negroide
The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
sa patienter kan have op til 31% lavere Cmax og 43% lavere AUC end patienter af anden race.
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
til Rimonabants farmakokinetik er ens i kvindelige og mandlige patienter.
The pharmacokinetics of rimonabant are similar in female and male patients.
ret Ældre:
Elderly:
Baseret på farmakokinetiske populationsanalyser (alder fra 18- 81 år), er en 75- årig patient estimeret til at have en 21% højere Cmax
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.
ise og en 27% højere AUC end en 40- årig patient.
d ise Patients with hepatic insufficiency:
Patienter med nedsat leverfunktion:
or regarding pharmacokinetics in moderate hepatic impairment.
tor Lettere nedsat leverfunktion ændrer ikke rimonabant- optagelse.
uth were not evaluated.
Patienter med alvorlig nedsat leverfunktion blev ikke evalueret.
Patients with renal impairment:
Patienter med nedsat nyrefunktion: au Nyrefunktionens effekt på farmakokinetikken af rimonabant er ikke specifikt undersøgt. ere Mild nedsat nyrefunktion, synes ikke at påvirke farmakokinetikken af rimonabant baseret på farmakokinetiske populationsforsøg.
Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect ge the pharmacokinetics of rimonabant.
Der er ingen data vedrørende alvorlig nedsat nyrefunktion. ng
There are no data in severe renal impairment. on
5. 3 Prækliniske sikkerhedsdata læ
5.3 Preclinical safety data ol
Bivirkninger, som ikke blev observeret i kliniske forsøg, men som blev set i dyr ved udsættelse for niveauer svarende til kliniske niveauer og med mulig relevans for klinisk brug, var som følger:
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to tn
Der blev ikke observeret ke
No convulsions were observed in dogs during a 3 month study.
kramper hos hunde under et 3 måneders forsøg.
to be associated with procedural stress such as handling of the animals.
En r ik
A proconvulsant activity of ro
proconvulsant aktivitet af rimonabant blev fundet i et ud af to safety farmakologiforsøg.
rimonabant was found in one of two safety pharmacology studies.
Der blev ikke observeret nogen bivirkninger i EEG mønsteret hos rotter ved rimonabantbehandling.
No adverse effect of rimonabant treatment was observed on EEG patterns in rats. lp
Forøget incidens og/ eller alvorlighed af kliniske tegn som antyder forøget berøringshypersesthesia, te
Increased incidence and/ or severity of clinical signs suggestive of increased tactile hyperesthesia were ina
En direkte effekt af rimonabant kan ikke påvises. dle
A direct effect of rimonabant cannot be ruled out. dic
En direkte effekt af rimonabant kan ikke påvises. mi
Me
I standard fertilitetsforsøg med hunrotter (dosering i 2 uger før parring) var der abnorm østrus cyklus og en nedsættelse af corpora lutea og fertilitetsindeks ved rimonabantdoser, som inducerede maternal toksicitet (30 og 60 mg/ kg/ dag).
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).
som tillod restitution for de initiale påvirkninger af rimonabant, blev der ikke set bivirkninger på fertilitet og østruscyklus.
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.
Vedrørende reproduktive parametre, blev der ikke observeret nogen forskel mellem behandlede og kontroldyr ved 30 mg/ kg, ved 60 mg/ kg var der stadig observeret effekt Læ
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).