natgillin/translations-raw huggingface dataset:
Patienten skal have målt serumkreatininniveauet før behandling med Aclasta.
Patients should have their serum creatinine level measured before receiving Aclasta.
Hos patienter med en nylig lavenergi hoftefraktur, anbefales det at give en infusion med Aclasta to eller flere uger efter hoftefraktur helingen.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair.
Patienten skal være velhydreret før og efter administration af Aclasta, dette er især vigtigt for patienter, som får behandling med diuretika.
Patients must be appropriately hydrated prior to and following administration of Aclasta; this is especially important for patients receiving diuretic therapy.
Der tilrådes forsigtighed, når Aclasta administreres sammen med lægemidler, der har signifikant indvirkning på nyrefunktionen (f. eks. aminoglykosider eller diuretika, som kan være årsag til dehydrering).
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration).
Patienter med hypocalcæmi skal behandles med tilstrækkelig indgivelse af calcium og D- vitamin før behandling med Aclasta påbegyndes.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta.
Andre forstyrrelser af mineralmetabolismen skal også behandles effektivt (f. eks. hypothyroidisme, intestinal calciummalabsorption).
Other disturbances of mineral metabolism must also be effectively treated (e. g. diminished parathyroid reserve, intestinal calcium malabsorption).
Lægen bør overveje klinisk monitorering af disse patienter.
Physicians should consider clinical monitoring for these patients.
Øget omsætning af knoglevævet er karakteristisk for Pagets sygdom af knoglerne.
Elevated bone turnover is a characteristic of Paget’ s disease of the bone.
På grund af zoledronsyres hurtige effekt på knogleomsætningen kan der udvikles forbigående hypocalcæmi, til tider symptomatisk, og er almindeligvis maksimal inden for de første 10 dage efter infusion af Aclasta.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Aclasta.
Det anbefales at give tilstrækkeligt med calcium og D- vitamin i forbindelse med administration af Aclasta.
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Yderligere tilrådes det kraftigt hos patienter med Pagets sygdom at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig, i mindst 10 dage efter administration af Aclasta.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration.
Hos patienter med Pagets sygdom anbefales det at måle serum calcium før infusion af Aclasta.
Measurement of serum calcium before infusion of Aclasta is recommended for patients with Paget´s disease.
Det anbefales at give en støddosis D- vitamin på 50. 000 til 125. 000 IU oralt eller intramuskulært før den første Aclasta infusion hos patienter med en nylig lavenergi hoftefraktur.
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
Aclasta må ikke blandes eller gives intravenøst med andre stoffer og skal gives gennem en separat infusionsslange ved en konstant infusionshastighed.
Aclasta must not be mixed or given intravenously with any other medication and must be given through a separate vented infusion line at a constant infusion rate.
Infusionen skal gennemføres i henhold til standard medicinsk praksis.
The infusion must be conducted according to standard medical practice.
- Opbevar Aclasta utilgængeligt for børn.
- Keep Aclasta out of the reach and sight of children.
- Anvend ikke Aclasta efter den udløbsdato, som er angivet på æsken og flasken.
- Do not use Aclasta after the expiry date which is stated on the carton and bottle.
Hvis præparatet
- After opening the bottle, the product should be used immediately in order to avoid microbial
ikke anvendes med det samme, er brugeren ansvarlig for opbevaringstid og – betingelser, som normalt ikke vil være længere end 24 timer ved 2°C - 8°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
lg EMEA/ H/ C/ 666
ise EMEA/ H/ C/ 666
sa EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
or EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
til EPAR - sammendrag for offentligheden
uth EPAR summary for the public
ret Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
ra This document is a summary of the European Public Assessment Report (EPAR).
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
ise undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
ge Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvis du ønsker yderligere oplysninger om din sygdomstilstand eller behandling, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Hvis du ønsker
What is ACOMPLIA?
tor yderligere oplysninger om baggrunden for CHMP’ s anbefalinger, kan du læse de faglige drøftelser (også en del af denne af EPAR).
lon
Hvad er ACOMPLIA? au ACOMPLIA er et lægemiddel, som indeholder det aktive stof rimonabant.
ACOMPLIA is a medicine containing the active substance rimonabant.
Det leveres som hvide, dråbeformede tabletter. ere Hvad anvendes ACOMPLIA til?
It is available as white, teardrop- shaped tablets. no
30 kg/ m², eller • som er overvægtige (med et BMI større end eller lig med 27 kg/ m²), og som også har en eller læ
ACOMPLIA is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, ct
flere andre risikofaktorer som f. eks. type 2- diabetes eller dyslipidæmi (unormalt højt fedtindhold i blodet).
such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
Lægemidlet udleveres kun efter recept. ke
The medicine can only be obtained with a prescription. du
Patienterne bør desuden r ik
The medicine should not be used in patients who ro
følge en diæt med reduceret kalorieindhold og øge deres fysiske aktivitetsniveau.
have severe problems with their liver or their kidneys. lp
Det aktive stof i ACOMPLIA, rimonabant, er en cannabinoid- receptorantagonist.
The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist.
Det virker ved at blokere en bestemt type receptorer, der kaldes cannabinoid- receptorer type 1 (CB1).
It acts by blocking a specific type of receptor, the cannabinoid type 1 (CB1) receptors.
Disse receptorer dle
The receptors are ina
Receptorerne findes også i adipocytter (fedtvæv). mi
also found in adipocytes (fat tissue).
Virkningerne af ACOMPLIA blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. ge
The effects of ACOMPLIA were first tested in experimental models before being studied in humans. dic
nærmere på patienter med type 2- diabetes.
One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Undersøgelserne sammenlignede virkningen af ACOMPLIA
The Me
En undersøgelse så også nærmere på, hvordan dette vægttab kunne vedligeholdes det andet år.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged studies compared the effect of ACOMPLIA with that of a placebo (a dummy treatment) on weight loss
lg Der er desuden foretaget fire undersøgelser af ACOMPLIA, hvor det blev anvendt som hjælp til at stoppe rygning.
One study also looked at how this loss could be maintained during the second year.
sa målte virkningen af behandlinger på 10 uger (et år i en af undersøgelserne) med hensyn til opnåelse af rygestop og tilbagefald det følgende år.
ise Four studies of ACOMPLIA as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
til Hvilken fordel viser undersøgelserne, at der er ved ACOMPLIA?
or What benefit has ACOMPLIA shown during the studies?
Efter et år havde alle patienter, der fik ACOMPLIA, opnået et større vægttab end dem, der fik placebo: de tabte gennemsnitligt 4, 9 kg mere end patienterne i placebo- gruppen, undtagen i undersøgelsen af
After one year, all patients who received ACOMPLIA lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the
ret sukkersygepatienter, hvor forskellen i vægttabet var 3, 9 kg.
uth difference in the weight loss was 3.9 kg.
ise at vurdere virkningen af ACOMPLIA på dette område.
The studies in smoking cessation did not show consistent results, and the effect of ACOMPLIA in this area was difficult to estimate.
tor Hvilken risiko er der forbundet med ACOMPLIA?
ra What is the risk associated with ACOMPLIA?
I løbet af undersøgelserne var de hyppigste bivirkninger ved ACOMPLIA (som ses hos flere end 1 ud af
During the studies, the most common side effects with ACOMPLIA (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
bivirkninger ved ACOMPLIA fremgår af indlægssedlen.
For the full list of all side effects
10 patienter) kvalme og infektioner i det øvre åndedrætssystem.
ge reported with ACOMPLIA, see the Package Leaflet.
ACOMPLIA bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for rimonabant ere eller andre af indholdsstofferne, eller af patienter, som ammer.
ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
ACOMPLIA bør heller ikke anvendes til patienter med svær depression, eller som behandles med antidepressive midler, da det kan øge risikoen for depression, herunder selvmordstanker hos et mindre antal patienter.
It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of lon depression, including thoughts about suicide in a small minority of patients.
forsigtighed i kombination med visse lægemidler, f. eks. ketoconazol eller itraconazol (lægemidler mod svamp), ritonavir (anvendes ved hiv- infektion), telithromycin eller clarithromycin (antibiotika). læ
Caution should be used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics). no
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at ACOMPLIA har vist sig effektivt til opnåelse af vægttab hos overvægtige eller svært overvægtige patienter med tilknyttede risikofaktorer. ke
The Committee for Medicinal products for Human Use (CHMP) concluded that ACOMPLIA had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Udvalget besluttede, at fordelene ved ACOMPLIA er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med r ik
The Committee decided that ACOMPLIA’ s benefits are greater than its risks when used, in addition to diet and ct
risikofaktorer såsom type 2- diabetes eller dyslipidæmi.
exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ACOMPLIA.
The Committee recommended that ACOMPLIA be given marketing authorisation. du
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af ACOMPLIA? te
Which measures are being taken to ensure the safe use of ACOMPLIA?
Firmaet, som fremstiller ACOMPLIA, iværksætter et program, der skal sikre, at lægemidlet anvendes til patienter til sundhedsmæssige formål frem for af kosmetiske årsager (ved at give uddannelsespakker til dle
The company that makes ACOMPLIA will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for ro
patienter og læger), og føre tilsyn med, hvordan lægemidlet anvendes.
patients and doctors, and to monitor how the medicine is used.
Firmaet anvender specifikke databaser til overvågning af bivirkninger ved ACOMPLIA, navnlig bivirkninger forbundet med nervesystemet. mi
The company will use specific databases to monitor ACOMPLIA’ s side effects, especially those linked to the nervous system. lp
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union ge
The European Commission granted a marketing authorisation valid throughout the European Union for ACOMPLIA to sanofi-aventis on 19 June 2006. ina
Læ
The full EPAR for ACOMPLIA can be found here.
Dette sammendrag blev sidst ajourført i 10- 2007.
This summary was last updated in 10-2007. dic Me
alg EU- nummer
e d is EU number
s EU/ 1/ 06/ 344/ 001
or administration EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002
Blister (PVC/ aluminium)
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
14 tabletter
14 tablets 28 tablets
til EU/ 1/ 06/ 344/ 002 EU/ 1/ 06/ 344/ 003
th EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004
Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet Film-coated tablet
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
28 tabletter 56 tabletter
56 tablets 70x1 tablets
t EU/ 1/ 06/ 344/ 004
u EU/ 1/ 06/ 344/ 005
Blister (PVC/ aluminium)
Blister (PVC/ aluminium)
70x1 tabletter
84 tablets
re EU/ 1/ 06/ 344/ 005 EU/ 1/ 06/ 344/ 006
a EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 007
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
Blister (PVC/ aluminium) Bottle (HDPE)
84 tabletter 98 tabletter
98 tablets 28 tablets
e EU/ 1/ 06/ 344/ 007
r EU/ 1/ 06/ 344/ 008
98 tabletter 500 tabletter
98 tablets
to EU/ 1/ 06/ 344/ 010
e EU/ 1/ 06/ 344/ 009
Blister (PVC/ aluminium)
Bottle (HDPE)
30 tabletter
500 tablets
au EU/ 1/ 06/ 344/ 011
g EU/ 1/ 06/ 344/ 010 EU/ 1/ 06/ 344/ 011
90 tabletter
30 tablets 90 tablets
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pro l i na d ic M e 1/ 1
1 BILAG I ng er PRODUKTRESUME ea uto ris er et til 1.
d ise or uth ra ge lon ANNEX I
LÆGEMIDLETS NAVN
SUMMARY OF PRODUCT CHARACTERISTICS no ct du ro lp ina dic Me
alg
1 1.
ACOMPLIA 20 mg filmovertrukne tabletter
d ACOMPLIA 20 mg film-coated tablets
alg En tablet indeholder 20 mg rimonabant.
Each tablet contains 20 mg rimonabant.
s Tabletterne indeholder cirka 115 mg laktose.
115 mg lactose.
til et 3.
uth 3.
Bikonvekse, tåreformede, hvide tabletter mærket med ” 20 ” på den ene side.
ra Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “ 20 ” on one side.
ris uto 4.
ge 4.
5. 1). er
4.1 Therapeutic indications lon 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). no
4. 2 Dosering og indgivelsesmåde ng
4.2 Posology and method of administration
Til voksne er den anbefalede dosis en 20 mg tablet dagligt som tages om morgenen før morgenmaden. læ
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. ct
Behandlingen bør introduceres med en lettere reduceret kaloriediæt.
The treatment should be introduced with a mildly reduced calorie diet. du
Sikkerhed og effekt af rimonabant er ikke undersøgt ud over 2 år. ke
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
•
• Special Populations ro
5. 2).
No dosage adjustment is required in elderly (see section 5.2).
ACOMPLIA bør anvendes med forsigtighed te
ACOMPLIA should be used with lp
4. 4).
caution in patients over 75 years of age (see section 4.4).
Patienter med nedsat leverfunktion: dle
Patients with hepatic insufficiency: ina
4. 4 og 5. 2). mi
ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2). dic
Patienter med nedsat nyrefunktion: ge
Patients with renal impairment:
5. 2).
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
4. 4 og 5. 2).
ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
Læ
Me
ACOMPLIA er ikke anbefalet til brug hos børn under 18 år p. g. a. mangel på data vedrørende effekt og sikkerhed.
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
2 4. 3 Kontraindikationer
2 4.3 Contraindications
Amning.
d Lactation.
4. 4).
Ongoing major depressive illness and/ or ongoing antidepressive treatment (see section 4.4)
alg 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
ise 4.4 Special warnings and precautions for use
4. 8).
or 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).
til Hos patienter med eksisterende selvmordstanker og/ eller med selvmordstanker og depressiv sygdom i anamnesen, bør rimonabant kun anvendes såfremt udbyttet ved behandlingen vurderes at overstige
In patients with current suicidal ideations and/ or with a history of suicidal ideation and depressive disorder rimonabant
et disse risici hos den individuelle patient (se pkt.
uth should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
4. 3 og 4. 8).
(See section 4.3 and 4.8).
Depressive sygdomme kan associeres med en øget risiko for at gøre skade
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
ris For at kunne vurdere de potentielle risici ved behandling med rimonabant, bør lægen nøje undersøge, om patienten tidligere har haft en depressiv sygdom.
ra 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.
uto Depressive tilstande kan forekomme hos patienter, som ikke har nogen åbenlyse risikofaktorer, bortset fra fedme.
ge Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Hvis depression bliver diagnoseret under rimonabant behandling, skal er
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. lon Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment.
behandling med rimonabant stoppes.
If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Patienten skal monitoreres og behandles på passende vis. ng
The patient should be monitored and treated appropriately.
Patienter, især dem med depressive sygdomme/ humør ændringer i anamnesen, (og pårørende eller andre relevante personer) bør gøres opmærksom på, at det er nødvendigt at monitorere forekomsten af læ
Patients, especially those with a history of depressive disorders/ mood alterations, (and relatives or no
sådanne symptomer og at søge læge øjeblikkeligt, hvis de skulle forekomme.
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.
Hvis psykisk ke
• Other psychiatric conditions ct
sygdom diagnosticeres under behandling med rimonabant, skal behandlingen ophøre. r ik
If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped. du
• Kramper Rimonabant er ikke undersøgt hos patienter i behandling for epilepsi.
• Seizures Rimonabant has not been studied in patients being treated for epilepsy.
Dog bør te
Rimonabant, ro
5. 3.
however, should be used with caution in these patients, see also section 5.3.
• Nedsat leverfunktion dle
• Hepatic impairment lp
Farmakokinetik og sikkerhed af rimonabant er ikke undersøgt hos patienter med svært nedsat leverfunktion; anvendelse hos disse patienter anbefales ikke. mi
The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended. ina
Der er begrænset data hos patienter med moderat nedsat nyrefunktion og ingen data vedrørende patienter med svært nedsat nyrefunktion.
• Renal impairment There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Rimonabant bør ikke anvendes hos patienter med svært nedsat nyrefunktion (se pkt.
Rimonabant should not be used in patients with severe renal impairment (see section dic
Læ
4.2 and 5.2).
• Ældre Effekt og sikkerhed af rimonabant hos patienter over 75 år er ikke tilstrækkeligt fastsat.
• Elderly The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently Me
5. 2).
Rimonabant should be used with caution in this population (see section 5.2).
3 Den kliniske effekt (vægttab) af rimonabant hos negroide er lavere end hos kaukasiere.
3 • Race The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
Dette kan skyldes en højere rimonabantclearance hos negroide end hos kaukasier, hvilket resulterer i lavere optagelse (se pkt.
This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure
5. 2).
d (see section 5.2).
• Diabetes patienter På grund af rimonabants effekt på blodsukkerniveauet, kan hypoglykæmi forekomme, når rimonabant
Monitoring of blood glucose level is
alg gives til diabetes patienter (se afsnit 4. 8).
or recommended in these patients.
s • Lægemiddelinteraktion Rimonabant bør anvendes med forsigtighed i kombination med potente CYP3A4 hæmmere (f. eks.
• Drug Interaction
4. 5).
uth Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
et • Lactose Da ACOMPLIA indeholder laktose, bør patienter med sjældne, arvelige problemer med
• Lactose
er galaktoseintolerans, Lapp laktasemangel eller glukose- galaktose malabsorption, ikke tage denne medicin.
ra Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
ris Patienter bør instrueres i ikke at forøge dosis af ACOMPLIA.
ge Patients should be instructed not to increase their dose of ACOMPLIA.
uto Patienter som havde haft kardivaskulært event (myokardieinfarkt, hjerteanfald etc.) inden for mindre end 6 måneder, blev ekskluderet i forsøgene med rimonabant. ea 4. 5 Interaktion med andre lægemidler og andre former for interaktion
Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago lon were excluded in the studies for rimonabant.