FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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).
English: Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites.
Danish: Rimonabant bliver hovedsageligt elimeneret via metabolisme og efterfølgende udskillelse af metabolitter via galden.
English: The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.
Danish: De mest almindelige bivirkninger, som førte til afbrudt behandling var: kvalme, humørsvingninger med depressive symptomer, depressive sygdomme, uro og svimmelhed.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de forsøg og pharmacovigilace aktiviteter som er beskrevet i Pharmacovigilance planen.
English: Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).
Danish: Alvorlige psykiske hændelser inklusiv depression eller humørændringer er forekommet hos patienter i behandling med ACOMPLIA (se afsnittet BIVIRKNINGER).
English: 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.
Danish: I præ- og postnatale udviklingsforsøg i rotter, gav påvirkning af rimonabant in utero og via mælken ingen ændringer i indlæring og hukommelse, men tvivlsomme påvirkninger på motorisk aktivitet og respons på lyd blev observeret hos unge rotter, som et resultat af rimonabants påvirkning.
English: Tendonitis Muscle cramp Muscle spasms
Danish: Tendonitis Muskelkramper Muskelspasmer
English: Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.
Danish: Bikonvekse, tåreformede, hvide tabletter mærket med ”20” på den ene side.
English: 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).
Danish: Depressive sygdomme eller humørændringer med depressive symptomer er rapporteret hos op til 10 %, og selvmordstanker hos op til 1 %, af patienterne, der blev behandlet med rimonabant (se pkt.
English: The in vivo inhibitory effect on CYP2C8 has not been studied.
Danish: Den in vivo hæmmende effekt på CYP2C8 er ikke undersøgt.
English: A direct effect of rimonabant cannot be ruled out.
Danish: En direkte effekt af rimonabant kan ikke påvises.
English: 5 How to store ACOMPLIA Further information
Danish: Sådan opbevarer De ACOMPLIA Yderligere oplysninger
English: Increased incidence and/or severity of clinical signs suggestive of increased tactile hyperesthesia were observed in rodent studies.
Danish: Forøget incidens og/eller alvorlighed af kliniske tegn som antyder forøget berøringshypersesthesia, blev observeret i forsøg med gnavere.
English: Tablet polishing: carnauba wax (E903)
Danish: Tablet voks: carnauba voks (E903)
English: 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.
Danish: Almindelige bivirkninger hos patienter i behandling med ACOMPLIA, som forekommer i mere end 1 ud af 100 men mindre end 1 ud af 10, inkluderer: urolig mave, opkastning, problemer med at sove, nervøsitet, depression, irritabilitet, svimmelhed, diarre, uro, kløe, overdreven sved, muskelkramper eller spasmer, træthed, blå mærker, senesmerter og betændelse (tendonitis), hukommelsestab, rygsmerter (iskias), forandret følsomhed (mindre følsom eller sviende eller prikkende følelse) i hænder og fødder, hedetur, fald, influenza og forstuvning af led.
English: Special Populations
Danish: Specielle befolkningsgrupper:
English: Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable with the clinical exposures.
Danish: Sporadiske misdannelser (anencephalitis, mikro-ophthalmitis, udvidede hjerneventrikler og omphalocele) blev observeret i kanin embryfoetal toksicitetsforsøg ved doser, som gav påvirkninger som var sammenlignelige med klinisk påvirkning.
English: It works by blocking specific receptors in the brain and fat tissues called CB1 receptors.
Danish: Det virker ved at blokere specifikke receptorer, kaldet CB1- receptorer i hjernen og fedtvæv.
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.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Frankrig sanofi-aventis S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italien På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/344/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/344/007
English: The tablets contain approx. 115 mg lactose.
Danish: Tabletterne indeholder cirka 115 mg laktose.
English: Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Danish: Ugennemsigtige hvide HDPE dåser indeholdende 28, 98 og 500 filmovertrukne tabletter.
English: It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received rimonabant 20 mg was beyond that expected from weight loss alone.
Danish: 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.
English: Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Danish: Rimonabant hæmmer eller fremmer ikke andre CYPenzymer eller P-glycoprotein (P-gp) in vitro.
English: Swallow the tablet whole.
Danish: Tabletten skal synkes hel.
English: There are reports in the literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the brain changes during development.
Danish: Der er rapporter i litteraturen om, at den rumlige distribution og densitet af CB1- receptorer i hjernen ændres under udviklingen hos både gnavere og mennesker.
English: This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure (see section 5.2).
Danish: Dette kan skyldes en højere rimonabantclearance hos negroide end hos kaukasier, hvilket resulterer i lavere optagelse (se pkt.
English: If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Danish: Hvis depression bliver diagnoseret under rimonabant behandling, skal behandling med rimonabant stoppes.
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.
Danish: Korrektiv behandling eller afbrydelse af rimonabant resulterede i helbredelse i alle tilfælde og behandlingen udviste ingen forskelle sammenlignet med tilfælde rapporteret i kontrolgruppen.
English: Clinical study results
Danish: Resultater i kliniske forsøg
English: It is estimated that approximately half of the mean improvement in HbA1c in patients receiving rimonabant 20 mg was beyond that expected from weight loss alone.
Danish: 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.
English: ACOMPLIA should be used with caution in patients with moderate hepatic impairment.
Danish: ACOMPLIA bør anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion.
English: 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).
Danish: Som supplement til diæt og motion til behandling af svært overvægtige (obese) (BMI ≥ 30 kg/m2), eller overvægtige (BMI > 27 kg/m2) patienter med associerede risikofaktor(er), såsom type 2 diabetes eller dyslipidaemia (se pkt.
English: Following multiple once-daily doses of 20 mg to healthy subjects in the fasted state, maximum plasma concentrations of rimonabant are achieved in approximately 2 hours with steady state plasma levels achieved within 13 days (Cmax = 196 ± 28.1 ng/ml; Ctrough = 91.6 ± 14.1 ng/ml; AUC0-24 = 2960 ± 268 ng.h/ml).
Danish: Efter mange doser af 20 mg givet en gang dagligt til fastende sunde personer, opnås maksimal plasmakoncentration af rimonabant efter ca. 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).
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 filmovertrukne tabletter
English: If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.
Danish: Hvis psykisk sygdom diagnosticeres under behandling med rimonabant, skal behandlingen ophøre.
English: Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment.
Danish: Rimonabant metaboliseres i leveren, og derfor anbefales forsigtighed ved behandling af patienter med moderat nedsat leverfunktion.
English: In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast.
Danish: Til voksne er den anbefalede dosis en 20 mg tablet dagligt som tages om morgenen før morgenmaden.
English: Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro.
Danish: Rimonabant metaboliseres via både CYP3A og amidohydrolase (primært hepatiske) veje in vitro.
English: There are no data in severe renal impairment.
Danish: Der er ingen data vedrørende alvorlig nedsat nyrefunktion.
English: Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Danish: Døsighed (lethargi), rysten, nattesved, paniksymptomer, hikke, vrede, rastløshed (dysphoria), følelsesforstyrrelser, selvmordstanker, aggressivitet eller aggressiv opførsel, hypoglykæmi (lavt blodsukker).
English: − Nervous disorders: convulsions, disturbance in attention, headache.
Danish: Nervesystemet: kramper, koncentrationsforstyrrelser, hovedpine.
English: France sanofi-aventis S.p.A. Strada Statale 17, Km 22 67019 Scoppito (AQ) Italy
Danish: Strada Statale 17, Km 22 67019 Scoppito (AQ) Italien
English: Rimonabant, however, should be used with caution in these patients, see also section 5.3.
Danish: Dog bør rimonabant anvendes med forsigtighed til disse patienter, se også pkt.
English: ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Danish: ACOMPLIA fås i blisterpakninger med 14, 28, 30, 56, 84, 90 og 98 tabletter, i perforerede enkeltdosis- blisterpakninger med 70 x 1 tabletter, og i hvide plastikdåser med 28, 98 og 500 tabletter.
English: Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle label for the presentations of 28, 98 and 500 film-coated tablets
Danish: Pakning for præsentationerne med 28, 98 og 500 filmovertrukne tabletter i HDPE dåser/ HDPE dåse etiket for præsentationerne med 28, 98 og 500 filmovertrukne tabletter
English: Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Danish: Tristhed, nedtrykt humør tab af interesse for tidligere behagelige aktiviteter, ophidselse, irritabilitet, , langsomme, hæmmede handlinger, dårlig koncentration, uro, søvnløshed, tanker eller ord om død eller selvmord.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19 June 2006
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The absolute change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%).
Danish: Den absolutte ændring i HbA1c ved et år var -0,6 for rimonabant 20 mg (baseline 7,3 %) og +0,1 for placebo (baseline 7,2 %).
English: Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.
Danish: Behandling med rimonabant frarådes til patienter med ukontrolleret psykisk sygdom.
English: 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.
Danish: ACOMPLIA er indiceret til behandling af svært overvægtige eller overvægtige patienter med yderligere risikofaktorer såsom diabetes (sukkersyge) eller forhøjet indhold af fedtstoffer i blodet, kaldet lipider (dyslipidæmi, forstyrrelse i blodets lipidindhold; især kolesterol og triglycerider), som supplement til diæt og motion.
English: Memory loss Dizziness Hypoaesthesia Sciatica Paresthesia
Danish: Hukommelsestab Svimmelhed Hypoaesthesia Ischias
English: The usual dose is one 20 mg tablet to be taken once daily in the morning before breakfast.
Danish: Den normale dosis er en 20 mg tablet taget en gang dagligt om morgenen før morgenmaden.
English: Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant.
Danish: Samtidig administration af CYP3A4 hæmmere vil føre til forøget optagelse af rimonabant.
English: No dosage adjustment is required for patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med mild eller moderat nedsat leverfunktion.
English: ACOMPLIA is contraindicated during breast-feeding (see section 4.3).
Danish: ACOMPLIA er kontraindiceret under amning (se pkt.
English: At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines.
Danish: ACOMPLIA forventes ikke at nedsætte Deres evne til at køre bil eller betjene maskiner ved den anbefalede dosis.
English: The active substance is rimonabant.
Danish: Aktivt stof: rimonabant.
English: 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.
Danish: ACOMPLIAs udseende og pakningstørrelse ACOMPLIA er dråbeformet, hvide filmovertrukne tabletter mærket med ”20” på den ene side.
English: Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Danish: Anvend ikke dette lægemiddel, hvis De ammer, eller hvis De planlægger at amme Deres barn.
English: You need to start and continue a reduced calorie diet and a physical activity program to get best results.
Danish: For at få det bedste resultat er det er nødvendigt, at De starter og fortsætter med en reduceret kaloriediæt og fysisk aktivitet.
English: There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose.
Danish: Den farmakokinetiske profil viser et plateau i optagelse ved 180 mg. Der er ingen specifik antidot for rimonabant; Derfor bør hensigtsmæssige supportive monitoreringer initieres i tilfælde af overdosering.
English: No adverse effect of rimonabant treatment was observed on EEG patterns in rats.
Danish: Der blev ikke observeret nogen bivirkninger i EEG mønsteret hos rotter ved rimonabantbehandling.
English: In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast.
Danish: ACOMPLIA 20 mg blev taget om morgenen sædvanligvis før morgenmad i de kliniske forsøg.
English: Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant.
Danish: Samtidig administration af CYP3A4 fremmere forventes at føre til reduceret optagelse af rimonabant.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret ACOMPLIA til Dem personligt.
English: Always take ACOMPLIA exactly as your doctor has told you.
Danish: ACOMPLIA bør altid anvendes i nøje overensstemmelse med Deres læges instruktioner.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of rimonabant.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg rimonabant.
English: If you take more ACOMPLIA than you should If you take more ACOMPLIA than you should tell a doctor or pharmacist.
Danish: Hvis De har taget for mange ACOMPLIA tabletter Fortæl det til lægen eller apoteket, hvis De har taget mere ACOMPLIA, end de skulle.
English: Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Danish: Forsigtighed anbefales under samtidig anvendelse af ACOMPLIA og potente CYP3A4 hæmmere (f.eks. ketoconazol, itraconazol, ritonavir, telithromycin, clarithromycin, nefazodon).
English: For the triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 1.62 mmol/l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/l).
Danish: 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 (baseline TG 1,65 mmol/l).
English: Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
Danish: Rimonabant bør anvendes med forsigtighed i kombination med potente CYP3A4 hæmmere (f.eks. ketoconazol, itraconazol, ritonavir, telithromycin, clarithromycin, nefazodon) (se pkt.
English: Each tablet contains 20 mg rimonabant.
Danish: En tablet indeholder 20 mg rimonabant.
English: For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/l).
Danish: En middelforøgelse for HDL-C på 16,4 % blev set for rimonabant 20 mg (baseline HDL-C 1,24 mmol/l) sammenlignet med en forøgelse på 8,9 % for placebo (baseline HDL-C 1,21 mmol/l).
English: 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).
Danish: I et andet forsøg med obese behandlings-naive type II diabetikere (Serenade) var den absolutte ændring i HbA1c ved 6 måneder -0,8 for rimonabant 20 mg og -0,3 for placebo (baseline for begge grupper: 7,9 %) (forskel -0,51, CI95% -0,78, -0,24 p < 0,001).
English: One film-coated tablet contains 20 mg rimonabant.
Danish: En filmovertrukken tablet indeholder 20 mg rimonabant.
English: The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001).
Danish: Forskellen var statistisk signifikant (forskel 7,9 % CI95 6,6 %; 9,2 %, p < 0,001).
English: Data are insufficient to draw conclusions regarding pharmacokinetics in moderate hepatic impairment.
Danish: Der er ikke tilstrækkelige data til at drage konklusioner vedrørende moderat nedsat leverfunktion.
English: Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Danish: Filmovertræk: laktosemonohydrat, hypromellose 15 mPa.s (E464), titandioxid (E171), macrogol 3000
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.
Danish: For at kunne vurdere de potentielle risici ved behandling med rimonabant, bør lægen nøje undersøge, om patienten tidligere har haft en depressiv sygdom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters of the presentations of 30, 70 x 1 and 90 film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til præsentationerne på 30, 70 x 1 og 90 filmovertrukne tabletter
English: The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p< 0.001).
Danish: Forskellen var statistisk signifikant (forskel -13,3 % CI95 - 16,5; -10,2 % p < 0,001).
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis
English: No dosage adjustment is required in elderly (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre (se pkt.
English: 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.
Danish: Der blev observeret forbedringer i HbA1c og kropsvægt i forsøget med type 2 diabetes patienter (RIODiabetes) behandlet med metformin eller sulfonylurea, som var overvægtige eller obese.
English: Convulsions were observed sporadically in studies in rodents and macaques.
Danish: Kramper blev sporadisk observeret i forsøg med gnavere og javaneseraber.
English: Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ACOMPLIA include:
Danish: Ikke almindelige bivirkninger hos patienter i behandling med ACOMPLIA, som forekommer i mindre end 1 ud af 100, men mere end 1 ud af 1000, inkluderer:
English: Patients with hepatic insufficiency:
Danish: Patienter med nedsat leverfunktion:
English: Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
Danish: Tabletkerne: majsstivelse, laktosemonohydrat, povidon K 30 (E1201), natriumcroscarmellose (E468), natriumlaurilsulfat (E487), mikrokrystalinsk cellulose (E460), magnesiumstearat
English: Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, p<0.001).
Danish: Forskellen var statistisk signifikant (forskel - 0,7 %, CI95% -0,80;-0,5, p < 0,001).
English: − Skin and subcutaneous tissue disorders: rash.
Danish: Hud og subkutane væv: udslæt
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet er receptpligtigt.
English: 174 Avenue de France F-75013 Paris France
Danish: 174 Avenue de France F-75013 Paris, Frankrig