FrancophonIA/ELRC3.0 huggingface dataset:
English: Atrial fibrillation and atrial flutter are caused by problems in the conduction of electrical impulses in the upper chambers of the heart (atria).
Danish: Atrieflimren og atrieflagren skyldes problemer ved overføringen af elektriske impulser i hjertets øvre kar (atria).
English: The medicine has a number of effects on the heart muscle, including reducing the flow of potassium ions (charged particles) out of the heart cells.
Danish: Lægemidlet har en række virkninger på hjertemusklen, herunder reduktion af strømmen af kaliumioner (ladede partikler) ud af hjertecellerne.
English: How is MULTAQ expected to work?
Danish: Hvordan forventes MULTAQ at virke?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har indgivet sine svar på spørgsmålene, gennemgår CHMP disse og vil muligvis stille eventuelle ubesvarede spørgsmål på dag 180, inden det afgiver en udtalelse.
English: MULTAQ was expected to help patients maintain normal heart rhythm and to reduce the heart rate.
Danish: MULTAQ forventedes at kunne hjælpe patienter med at opretholde en normal hjerterytme og nedsætte hjertefrekvensen.
English: Based on the review of the data and the company's response to the CHMP's list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that MULTAQ could not be approved for the treatment of atrial fibrillation or atrial flutter.
Danish: På baggrund af gennemgangen af dataene og virksomhedens svar på CHMP's liste med spørgsmål på tidspunktet for tilbagetrækning af ansøgningen havde CHMP sine betænkeligheder og var af den foreløbige opfattelse, at MULTAQ ikke kunne godkendes til behandling af atrieflimren eller atrieflagren.
English: The patients' heart rates were measured when they were resting.
Danish: Patienternes hjertefrekvenser blev målt i hviletilstand.
English: What was MULTAQ expected to be used for?
Danish: Hvad skulle MULTAQ anvendes til?
English: The studies examined how long it took for atrial fibrillation or flutter to return.
Danish: I undersøgelserne blev det undersøgt, hvor lang tid der gik, før patienternes atrieflimren eller atrieflagren vendte tilbage.
English: According to their guidelines for medicines used to correct heart rhythm, the CHMP would need to assess the results of a trial comparing MULTAQ to an existing medicine before it can be granted a licence.
Danish: I henhold til deres retningslinjer for vurdering af lægemidler til korrigering af hjerterytme ville CHMP skulle vurdere resultaterne af en undersøgelse, der havde til formål at sammenligne MULTAQ med et eksisterende lægemiddel, før der kunne udstedes en markedsføringstilladelse.
English: The company presented the results of two clinical trials comparing the effects of MULTAQ and placebo (a dummy treatment) on the maintenance of normal heart rhythm.
Danish: Virksomheden fremlagde resultaterne af to kliniske undersøgelser, der sammenlignede virkningen af MULTAQ og placebo (en snydebehandling) med hensyn til opretholdelse af en normal hjerterytme.
English: The Company has informed the CHMP that there are no consequences for patients currently included in clinical trials with MULTAQ.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ikke vil få nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med MULTAQ.
English: The company also presented the results of a third study that compared the effects of MULTAQ and placebo on the heart rate in 174 patients who had had atrial fibrillation continuously for over six months.
Danish: Virksomheden fremlagde også resultaterne af en tredje undersøgelse, som sammenlignede virkningen af MULTAQ og placebo på hjertefrekvensen hos 174 patienter, som havde haft vedvarende atrieflimren eller atrieflagren i mere end seks måneder.
English: The CHMP was concerned that the studies presented by the company had not sufficiently shown that MULTAQ's effects on heart rate and rhythm would be beneficial to patients, since they had not compared MULTAQ to an existing medicine licensed for the same conditions.
Danish: CHMP havde betænkeligheder ved, at de af virksomheden fremlagte undersøgelsesdata ikke i tilstrækkelig grad viste, at MULTAQ's virkning på hjertefrekvensen og -rytmen ville være gavnlig for patienterne, eftersom man ikke havde sammenlignet MULTAQ med et eksisterende lægemiddel, der var godkendt til behandling af disse tilstande.
English: MULTAQ was to be used to treat patients with atrial fibrillation or atrial flutter.
Danish: MULTAQ skulle have været anvendt til behandling af patienter med atrieflimren eller atrieflagren.
English: The CHMP also had concerns over a higher rate of side effects in patients taking MULTAQ than those taking placebo.
Danish: CHMP havde også betænkeligheder over en højere bivirkningsfrekvens hos patienter, der tog MULTAQ, sammenlignet med patienter, som fik placebo.
English: The CHMP was also concerned that the levels of MULTAQ could be altered in patients taking some other medicines, including medicines used to treat the heart.
Danish: CHMP havde også betænkeligheder ved, at koncentrationerne af MULTAQ kunne ændre sig hos patienter, som tog anden medicin samtidig, herunder hjertemedicin.
English: Patients should be instructed not to increase their dose of ZIMULTI.
Danish: Patienter bør instrueres i ikke at forøge dosis af ZIMULTI.
English: Subjects with a 5% weight reduction
Danish: Personer med 5 % vægt reduktion
English: ZIMULTI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Danish: ZIMULTI er ikke anbefalet til brug hos børn under 18 år p.g.a. mangel på data vedrørende effekt og sikkerhed.
English: ZIMULTI should not be taken during pregnancy.
Danish: ZIMULTI bør ikke anvendes under graviditet.
English: Very common (≥10%); Common (≥ 1, <10%); Uncommon (≥ 0.1, <1%); Rare (≥ 0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 10 %); Almindelig (≥ 1, < 10 %); Usædvanlig (≥ 0,1, < 1 %); Sjælden (≥ 0,01, < 0,1 %); Meget sjælden (< 0,01 %), ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: The in vitro human plasma protein binding of rimonabant is high (>99.9%) and non-saturable over a wide concentration range.
Danish: In vitro human plasmaproteinbinding af rimonabant er høj (> 99,9 %) og ikke-mættet over et stort koncentrationsområde.
English: Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Danish: ZIMULTI 20 mg havde generelt ingen signifikant effekt på Total-C eller LDL-C niveauer.
English: Patients should notify their physician if they become pregnant during treatment with ZIMULTI.
Danish: Patienter bør informere deres læge, hvis de bliver gravide under behandling med ZIMULTI.
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ZIMULTI.
Danish: Kontakt straks Deres læge hvis De bliver gravid, hvis De har formodning om, at De er gravid eller planlægger at blive gravid, mens De anvender ZIMULTI.
English: INFORMATION IN BRAILLE ZIMULTI
Danish: INFORMATION I BRAILLE-SKRIFT ZIMULTI
English: Do not use ZIMULTI after the expiry date which is stated on the outer packaging after EXP.
Danish: Brug ikke ZIMULTI efter den udløbsdato, der står på pakningen.
English: The percentage of patients reaching HbA1c <7% was 51% in the rimonabant group and 35% in the placebo group.
Danish: Procentdelen af patienter, som opnåede HbA1c < 7 %, var 51 % i rimonabant-gruppen og 35 % i placebo-gruppen.
English: Joint sprain *frequency is based only on reports in obese or overweight diabetic patients.
Danish: Ledforstuvning * frekvens er kun baseret på rapporter på obese eller overvægtige personer.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen
English: If you experience symptoms of depression (see below) during treatment with ZIMULTI you should contact your doctor and stop the treatment.
Danish: Hvis De oplever depressive symptomer (se nedenfor) under behandling med ZIMULTI, bør De kontakte Deres læge og stoppe behandlingen.
English: Injury, Poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Important information about some of the ingredients of ZIMULTI ZIMULTI tablets include lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i ZIMULTI ZIMULTI indeholder laktose.
English: Subjects with a 10% weight reduction Difference (CI 95%)
Danish: Personer med 10 % vægt reduktion Forskel (CI 95 %)
English: Taking ZIMULTI with food and drink ZIMULTI should be taken once daily in the morning before breakfast.
Danish: Hvordan man anvender ZIMULTI sammen med mad og drikkevarer ZIMULTI bør tages en gang dagligt om morgenen før morgenmaden.
English: If you forget to take ZIMULTI Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Danish: Tag tabletten så snart De husker det, men De må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: 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.
Danish: Sikkerheden for ZIMULTI 20 mg er blevet undersøgt hos ca. 2500 patienter i forsøg som undersøgte effekten på metabolisme og vægttab hos overvægtige og stærkt overvægtige patienter og hos ca. 3800 patienter i andre indikationer.
English: Since ZIMULTI tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Danish: Da ZIMULTI indeholder laktose, bør patienter med sjældne, arvelige problemer med galaktoseintolerans, Lapp laktasemangel eller glukose-galaktose malabsorption, ikke tage denne medicin.
English: Regarding reproductive parameters, at 30 mg/kg no differences were observed between treated animals and controls , at 60 mg/kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Danish: 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 (mindre antal af corpora lutea, total implantationsfostre og levedygtige fostre).
English: Patients had a BMI ≥30 kg/m² or BMI>27 kg/m² with hypertension and/or dyslipidemia at inclusion.
Danish: Patienterne havde et BMI ≥ 30 kg/m2 eller BMI > 27 kg/m2 med hypertension og/eller dyslipaedimia ved inklusionen.
English: ZIMULTI 20 mg was effective in maintaining weight loss up to two years.
Danish: ZIMULTI 20 mg var effektiv til at vedligeholde vægttab i op til 2 år.
English: 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.
Danish: Signifikant middelvægtreduktion fra baseline til et år for ZIMULTI 20 mg versus placebo blev demonstreret i tre forsøg foretaget med ikke diabetes patienter.
English: The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥1%) or considered clinically relevant (for events <1%).
Danish: Den følgende tabel (Tabel 1) viser alle behandlingsrelaterede bivirkninger fra 4 placebokontrollerede 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 %) eller når den blev betragtet som klinisk relevant (for tilfælde < 1 %).
English: Patients who received ZIMULTI 20 mg for one year were re-randomized to ZIMULTI 20 mg or placebo.
Danish: Patienter, der fik ZIMULTI 20 mg, blev rerandomiseret til at få ZIMULTI 20 mg eller placebo.
English: − if you are less than 18 years of age.
Danish: ZIMULTI til personer under 18 år
English: Serious psychiatric events including depression or mood changes have been reported in patients taking ZIMULTI (see section POSSIBLE SIDE EFFECTS).
Danish: Alvorlige psykiske hændelser inklusiv depression eller humørændringer er forekommet hos patienter i behandling med ZIMULTI (se afsnittet BIVIRKNINGER).
English: What ZIMULTI is and what it is used for Before you take ZIMULTI How to take ZIMULTI Possible side effects
Danish: ZIMULTIs virkning, og hvad De skal bruge det til Det skal De vide, før De begynder at bruge ZIMULTI Sådan skal De bruge ZIMULTI Bivirkninger
English: WHAT ZIMULTI IS AND WHAT IT IS USED FOR
Danish: ZIMULTIS VIRKNING, OG HVAD DE SKAL BRUGE DET TIL
English: ZIMULTI should be used with caution in patients over 75 years of age (see section 4.4).
Danish: ZIMULTI bør anvendes med forsigtighed hos patienter ældre end 75 år (se pkt.
English: Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ZIMULTI 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 ZIMULTI, 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: Non-diabetic studies
Danish: Ikke-diabetesforsøg
English: Laboratory adverse events ZIMULTI has not been shown to alter laboratory test values.
Danish: Laboratorie bivirkninger ZIMULTI har ikke vist påvirkning af laboratorietestværdier.
English: 5 How to store ZIMULTI Further information
Danish: Sådan opbevarer De ZIMULTI Yderligere oplysninger
English: ZIMULTI is contraindicated during breast-feeding (see section 4.3).
Danish: ZIMULTI er kontraindiceret under amning (se pkt.
English: Psychiatric disorders disorders Mood alterations with depressive symptoms Anxiety
Danish: Depressive sygdomme Humørsvingninger med depressive symptomer Angst
English: ZIMULTI 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: ZIMULTI fås i blisterpakninger med 14, 28, 30, 56, 84, 90 og 98 tabletter, i perforerede enkeltdosisblisterpakninger med 70 x 1 tabletter, og i hvide plastikdåser med 28, 98 og 500 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: ZIMULTI should be used with caution in patients with moderate hepatic impairment.
Danish: ZIMULTI bør anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/345/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/345/007
English: Do not pass it on to others.
Danish: Lad derfor være med at give ZIMULTI til andre.
English: If you take more ZIMULTI than you should If you take more ZIMULTI than you should tell a doctor or pharmacist.
Danish: Hvis De har taget for mange ZIMULTI tabletter Fortæl det til lægen eller apoteket, hvis De har taget mere ZIMULTI, end de skulle.
English: ZIMULTI 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: ZIMULTI 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: ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT)
Danish: ZIMULTI 20 mg filmovertrukne tabletter (rimonabant)
English: PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Danish: PVC-aluminium pakning indeholdende 14, 28, 30, 56, 84, 90 og 98 filmovertrukne tabletter.
English: Diabetic study
Danish: Diabetesforsøg
English: The active substance is rimonabant.
Danish: - Aktivt stof: rimonabant.
English: Take special care with ZIMULTI
Danish: Vær ekstra forsigtig med at tage ZIMULTI
English: Caution is advised during concomitant use of ZIMULTI and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Danish: Forsigtighed anbefales under samtidig anvendelse af ZIMULTI og potente CYP3A4 hæmmere (f.eks. ketoconazol, itraconazol, ritonavir, telithromycin, clarithromycin, nefazodon).
English: Always take ZIMULTI exactly as your doctor has told you.
Danish: ZIMULTI bør altid anvendes i nøje overensstemmelse med Deres læges instruktioner.
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: MARKETING AUTHORIZATION NUMBER EU/1/06/345/001-011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/345/001-011
English: The active ingredient of ZIMULTI is rimonabant.
Danish: Det aktive stof i ZIMULTI hedder rimonabant.
English: In clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast.
Danish: ZIMULTI 20 mg blev taget om morgenen sædvanligvis før morgenmad i de kliniske forsøg.
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: 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: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 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: 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: System Organ Class
Danish: Tabel 1: Organ-klasse system Meget almindelig Almindelig
English: Driving and using machines At the recommended dose, ZIMULTI is not expected to reduce your ability to drive and use machines.
Danish: ZIMULTI forventes ikke at nedsætte Deres evne til at køre bil eller betjene maskiner ved den anbefalede dosis.
English: At two years, the difference in total weight loss between ZIMULTI and placebo was -4.2 kg (CI95% -5.0;-3.4, p<0.001).
Danish: Ved 2 år var forskellen i totalt vægttab mellem ZIMULTI og placebogruppen -4,2 kg (CI955,0;-3,4, p < 0,001).
English: 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
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: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE
English: NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets rimonabant
Danish: LÆGEMIDLETS NAVN ZIMULTI 20 mg filmovertrukne tabletter rimonabant
English: Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ZIMULTI include:
Danish: Ikke almindelige bivirkninger hos patienter i behandling med ZIMULTI, som forekommer i mindre end 1 ud af 100, men mere end 1 ud af 1000, inkluderer:
English: 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).
Danish: Forskellen mellem 20 mgog placebo-gruppen, i den gennemsnitlige ændring af kropsvægt, var 3,8 kg (CI95% -5,0, -2,6 p < 0,001).
English: Like all medicines, ZIMULTI can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on ZIMULTI include: nausea and upper respiratory tract infection.
Danish: ZIMULTI kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 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).
Danish: 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).
English: NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN ZIMULTI 20 mg filmovertrukne tabletter.
English: What ZIMULTI contains
Danish: ZIMULTI indeholder:
English: This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen Spørg på apoteket, hvordan De skal aflevere medicinrester.
English: What ZIMULTI looks like and contents of the pack ZIMULTI 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Danish: ZIMULTI er dråbeformet, hvide filmovertrukne tabletter mærket med ”20” på den ene side.
English: Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ZIMULTI include: hallucinations.
Danish: Sjældne bivirkninger hos patienter i behandling med ZIMULTI, som forekommer i mindre end 1 ud af 1000, inkluderer:
English: 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).
Danish: 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 (forskel4,9 kg CI95 % -5,3; -4,4, p < 0,001).
English: 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).
Danish: 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).