FrancophonIA/ELRC3.0 huggingface dataset:
English: Cariprazine should be used with caution in patients with risk factors for stroke.
Danish: Cariprazin skal anvendes med forsigtighed hos patienter med risikofaktorer for apopleksi.
English: If you forget to take Reagila
Danish: Hvis du har glemt at tage Reagila
English: No dose adjustment is required in patients with mild to moderate renal impairment (Creatinine Clearance (CrCl) ≥ 30 mL/min and < 89 mL/min).
Danish: Der er ikke behov for dosisjustering hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance (CrCl) ≥ 30 ml/min og < 89 ml/min).
English: QR code to be included www.reagila.com
Danish: QR-kode skal anføres www.reagila.com
English: Metabolism of cariprazine and its major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), is mediated mainly by CYP3A4 with a minor contribution of CYP2D6.
Danish: Metaboliseringen af cariprazin og dets vigtigste aktive metabolitter, desmethyl-cariprazin (DCAR) og didesmethyl-cariprazin (DDCAR), medieres overvejende af CYP3A4, med et mindre bidrag fra CYP2D6.
English: With cariprazine no QT interval prolongation was detected compared to placebo in a clinical trial designed to assess QT prolongation (see section 5.1).
Danish: Med cariprazin sås der ingen forlængelse af QT-intervallet sammenlignet med placebo i et klinisk forsøg, som var designet til at vurdere QT-forlængelse (se pkt.
English: (Rare side effect) - combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness.
Danish: (Sjælden bivirkning ) - en kombination af feber, svedafsondring, muskelstivhed og sløvhed eller søvnighed.
English: Cariprazine and its metabolites were excreted in milk of rats during lactation.
Danish: Cariprazin og dets metabolitter blev udskilt i mælk hos diegivende rotter.
English: However, a statistically significant difference (p< 0.001) in favour of cariprazine over risperidone was observed from Week 10 onward (Table 2).
Danish: Der blev dog observeret en statistisk signifikant forskel (p< 0,001) til fordel for cariprazin i forhold til risperidon fra uge 10 og frem (tabel 2).
English: Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box.
Danish: Gennemsigtig, hård blister i PVC/PE/PVDC, varmeforseglet med hård aluminiumsfolie som bagside i en foldet kartonæske.
English: Cariprazine and its major active metabolites are not substrates of P-glycoprotein (P-gp), the organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), and the breast cancer resistance protein (BCRP).
Danish: Cariprazin og dets vigtigste aktive metabolitter er ikke substrater for P-glykoprotein (P-gp), de organiske aniontransporterende polypeptider 1B1 og 1B3 (OATP1B1 og OATP1B3), samt brystcancerresistensprotein (BCRP).
English: Akathisia was reported in 10.0% in patients treated with cariprazine and 5.2% in the risperidone group.
Danish: Akatisi blev rapporteret hos 10,0 % i af de patienter, der blev behandlet med cariprazin, og 5,2 % i risperidon-gruppen.
English: Adverse drug reactions (ADRs) based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term.
Danish: Bivirkninger baseret på poolede data fra studier af cariprazin til behandling af skizofreni er opstillet efter systemorganklasse og foretrukken term.
English: In the negative symptom study, the mean change of body weight was -0.3 kg for cariprazine and +0.6 kg for risperidone and PCS weight gain was observed in 6% of the cariprazine group while 7.4% of the risperidone group.
Danish: I studiet af negative symptomer var den gennemsnitlige ændring i legemsvægt -0,3 kg for cariprazin og +0,6 kg for risperidon, og vægtøgning med mulig klinisk relevans blev observeret hos 6 % i cariprazin-gruppen og 7,4 % i risperidon-gruppen.
English: Concomitant administration of strong or moderate CYP3A4 inducers (see section 4.5).
Danish: Samtidig administration af kraftige eller moderate CYP3A4-induktorer (se pkt.
English: It is currently unknown whether cariprazine may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a second barrier method.
Danish: Det vides på nuværende tidspunkt ikke, om cariprazin kan nedsætte virkningen af hormonelle antikonceptiva med systemisk virkning, og derfor skal kvinder, som anvender hormonelle antikonceptiva med systemisk virkning, anvende en ekstra barrieremetode.
English: Photophobia Cataract
Danish: Fotofobi Katarakt
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: After repeated administration plasma exposure of cariprazine and its two major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), increases proportionally over the therapeutic dose range of 1.5 to 6 mg.
Danish: Efter gentagen administration stiger plasmaeksponering for cariprazin og dets to vigtigste aktive metabolitter, desmethyl-cariprazin (DCAR) og didesmethyl-cariprazin (DDCAR), proportionalt i det terapeutiske dosisinterval på 1,5 til 6 mg.
English: What you need to know before you take Reagila
Danish: Det skal du vide, før du begynder at tage Reagila
English: Risk of cerebrovascular accidents (CVA)
Danish: Risiko for cerebrovaskulære hændelser
English: Vision blurred Eye irritation Intraocular pressure increased
Danish: Øjenirritation Øget intraokulært tryk
English: 1103 Budapest HUNGARY
Danish: 1103 Budapest UNGARN
English: Risperidone LS mean
Danish: Risperidon LS middel
English: However, a statistically significant difference (p=0.002) in favour of cariprazine over risperidone was observed from Week 14 onward (Table 2).
Danish: Der blev dog observeret en statistisk signifikant forskel (p< 0,002) til fordel for cariprazin i forhold til risperidon fra uge 14 og frem (tabel 2).
English: It is currently unknown if cariprazine may reduce the effectiveness of systemically acting hormonal contraceptives and therefore women using systemically acting hormonal contraceptives should add a barrier method (see section 4.5).
Danish: Det vides på nuværende tidspunkt ikke, om cariprazin kan nedsætte virkningen af hormonelle antikonceptiva med systemisk virkning, og derfor skal kvinder, som anvender hormonelle antikonceptiva med systemisk virkning, anvende en ekstra barrieremetode (se pkt.
English: Cases of venous thromboembolism have been reported with antipsychotic medicinal products.
Danish: Der er blevet rapporteret om tilfælde af venøs tromboemboli i forbindelse med antipsykotika.
English: Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Danish: Tegn på højt blodsukker er overdreven tørst, store vandladninger, øget appetit og en følelse af svaghed - har haft krampeanfald eller epilepsi.
English: Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole) depression (herbal therapy containing St. John's wort (Hypericum perforatum) and medicines containing nefazodone) epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin) heart disease (medicines containing diltiazem and verapamil) sleepiness (medicines containing modafinil) high blood pressure in the lungs (medicines containing bosentan).
Danish: Cushings syndrom, hvor kroppen danner for meget cortisol (lægemidler, som indeholder ketoconazol) depression (urtemidler, som indeholder prikbladet perikon (Hypericum perforatum) og lægemidler, som indeholder nefazodon) epilepsi og krampeanfald (lægemidler, som indeholder carbamazepin, phenobarbital eller phenytoin) hjertesygdomme (lægemidler, som indeholder diltiazem eller verapamil) søvnighed (lægemidler, som indeholder modafinil) højt blodtryk i lungerne (lægemidler, som indeholder bosentan).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Gedeon Richter Plc.
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Gedeon Richter Plc.
English: Elevated liver transaminases (ALT, AST) are frequently observed with antipsychotic treatment.
Danish: Forhøjede levertransaminaser Forhøjede levertransaminaser (ALAT, ASAT) ses hyppigt ved behandling med antipsykotika.
English: Other medicines and Reagila
Danish: Brug af anden medicin sammen med Reagila
English: Safety and efficacy of cariprazine have not been evaluated in patients with severe hepatic impairment (Child-Pugh score between 10 and 15).
Danish: Cariprazins sikkerhed og virkning er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-score mellem 10 og 15).
English: Women of childbearing potential must be advised to avoid pregnancy while on Reagila.
Danish: Kvinder i den fødedygtige alder skal instrueres om at undgå graviditet, så længe de anvender Reagila.
English: Ask your doctor about appropriate choices of contraception.
Danish: Tal med lægen om den bedst egnede prævention.
English: Cariprazine and its metabolites are excreted in milk of rats during lactation (see section 5.3).
Danish: Cariprazin og dets metabolitter udskilles i mælken hos rotter under diegivning (se pkt.
English: Parkinsonism was experienced in 7.8% and 1.0% in cariprazine and placebo group respectively.
Danish: Parkinsons sygdom forekom hos hhv. 7,8 % og 1,0 % i cariprazin- og placebo-gruppen.
English: Titanium dioxide (E 171) Gelatin
Danish: Titandioxid (E171) Gelatine
English: During the double-blind treatment period, > 60 msec increases from baseline in QTcB were observed in 3 cariprazine-treated patients (3.1%) and 2 placebo-treated patients (2%).
Danish: Under den dobbeltblindede behandlingsperiode blev der observeret en stigning på > 60 msek fra baseline i QTcB hos 3 cariprazinbehandlede patienter (3,1 %) og 2 placebobehandlede patienter (2 %).
English: Cariprazine and its major active metabolites are not inhibitors of transporters OATP1B1, OATP1B3, BCRP, organic cation transporter 2 (OCT2), and organic anion transporters 1 and 3 (OAT1 and OAT3) in vitro.
Danish: Cariprazin og dets vigtigste aktive metabolitter er ikke hæmmere af transportørerne OATP1B1, OATP1B3, BCRP, organisk kationtransportør 2 (OCT2) og organisk aniontransportør 1 og 3 (OAT1 og OAT3) in vitro.
English: Safety and efficacy of cariprazine have not been evaluated in patients with severe renal impairment (CrCl < 30 mL/min).
Danish: Cariprazins sikkerhed og virkning er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min).
English: 7 hard capsules 14 hard capsules 21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
Danish: 7 hårde kapsler 14 hårde kapsler 21 hårde kapsler 28 hårde kapsler 30 hårde kapsler 49 hårde kapsler 56 hårde kapsler 60 hårde kapsler 84 hårde kapsler 90 hårde kapsler 98 hårde kapsler
English: 21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
Danish: 21 hårde kapsler 28 hårde kapsler 30 hårde kapsler 49 hårde kapsler 56 hårde kapsler 60 hårde kapsler 84 hårde kapsler 90 hårde kapsler 98 hårde kapsler
English: Female patients of child-bearing potential must use highly effective contraceptive methods during treatment and for at least 10 weeks following the last dose of Reagila.
Danish: Kvindelige patienter i den fødedygtige alder skal anvende meget sikker antikonception under behandlingen og i mindst 10 uger efter den sidste dosis Reagila.
English: - seizure - loss of memory, loss of speech - eye discomfort in bright light - clouding of the lens in the eye leading to a decrease in vision (cataract) - difficulty in swallowing - reduced levels of a type of white blood cells, this can make you more susceptible to infections - underactive thyroid gland
Danish: - krampeanfald - hukommelsestab, manglende evne til at tale - ubehag ved skarpt lys, uklarhed i linsen i øjet, som medfører nedsat synsevne (grå stær) - synkebesvær - lavt antal af en type hvide blodlegemer; dette kan gøre dig mere udsat for infektioner - underaktiv skjoldbruskkirtel.
English: The same information is also available on the following URL: www.reagila.com
Danish: Disse oplysninger findes også på www.reagila.com
English: Cariprazine is metabolized by CYP3A4 and, to a lesser extent, by CYP2D6, to DCAR and HCAR.
Danish: Cariprazin metaboliseres af CYP3A4 og, i mindre grad, af CYP2D6 til DCAR og HCAR.
English: as well as PANSS-FSNS response rates (PANSS FSNS ≥ 30% improvement at Week 26; p= 0.003)
Danish: samt PANSS-FSNS responsrater (PANSS FSNS ≥ 30 % forbedring ved uge 26; p=0,003) understøttede resultaterne af de primære og sekundære virkningsparametre.
English: Co-administration of cariprazine with strong and moderate inducers of CYP3A4 may result in a significant decrease in total cariprazine exposure, therefore the co-administration of cariprazine and strong or moderate CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin) is contraindicated (see section 4.3).
Danish: Samtidig administration af cariprazin og kraftige eller moderate CYP3A4-induktorer kan medføre et betydeligt fald i eksponering for total cariprazin, og derfor er samtidig administration af cariprazin og kraftige eller moderate CYP3A4-induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin, prikbladet perikon (Hypericum perforatum), bosentan, efavirenz, etravirin, modafinil, nafcillin) kontraindiceret (se pkt.
English: Akathisia was reported in 3.9% in patients treated with cariprazine, versus 2.0% in the placebo group.
Danish: Akatisi blev rapporteret hos 3,9 % af de patienter, der fik cariprazin, kontra 2,0 % i placebogruppen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Reagila 1,5 mg hårde kapsler
English: Hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5-9).
Danish: Der er ikke behov for dosisjustering hos patienter med let til moderat nedsat leverfunktion (ChildPugh-score mellem 5 og 9).
English: 4Dystonia: Blepharospasm, Dystonia, Muscle tightness, Oromandibular dystonia, Torticollis, Trismus 5Other extrapyramidal diseases and abnormal movement disorders: Balance disorder, Bruxism, Drooling, Dysarthria, Gait deviation, Glabellar reflex abnormal, Hyporeflexia, Movement disorder, Restless legs syndrome, Salivary hypersecretion, Tongue movement disturbance 6Dyskinesia: Choreoathetosis, Dyskinesia, Grimacing, Oculogyric crisis, Protrusion tongue
Danish: 4Dystoni: Blefarospasme, dystoni, muskelstramhed, oromandibulær dystoni, torticollis, trismus 5Andre ekstrapyramidale sygdomme og forstyrrelser med unormale bevægelser: Balanceforstyrrelse, bruxismus, savlen, dysartri, afvigende gang, unormal glabella-refleks, hyporefleksi, bevægelsesforstyrrelse, uro i benene, overdreven spytafsondring, tunge-bevægelsesforstyrrelse 6Dyskinesi: Choreoathetose, dyskinesi, grimassering, okulogyr krise, tungeprotrusion
English: Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura red AC (E129).
Danish: Reagila 3 mg, 4,5 mg og 6 mg hårde kapsler indeholder Allura red AC (E129).
English: - feeling of restlessness and inability to sit still - Parkinsonism - a medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, steps, shaking, little or no facial expression, muscle stiffness, drooling
Danish: - rastløshed og manglende evne til at sidde stille - Parkinsons sygdom, som er en sygdom med mange forskellige symptomer, der omfatter nedsatte eller langsomme bevægelser, langsom tankegang, ryk, når armen eller benet bøjes (tandhjulsrigiditet), slæbende skridt, rysten, udtryksløst ansigt, muskelstivhed, savlen
English: Cariprazine has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Danish: Cariprazin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pughklasse C) (se pkt.
English: Akathisia2 Parkinsonism3
Danish: Nervesystemet Akatisi2 Parkinsons sygdom3
English: Cariprazine should be used cautiously in patients with history of seizures or with conditions that potentially lower the seizure threshold.
Danish: Cariprazin bør anvendes med forsigtighed hos patienter med tidligere krampeanfald eller med tilstande, som potentielt sænker krampetærsklen.
English: DCAR is further metabolized by CYP3A4 and to a lesser extent by CYP2D6 into DDCAR and HDCAR.
Danish: DCAR metaboliseres yderligere af CYP3A4 og i mindre grad af CYP2D6 til DDCAR og HDCAR.
English: Sleep disorders1 Anxiety
Danish: Søvnforstyrrelser1 Angst
English: The rate of discontinuation due to EPS related ADRs was low.
Danish: Seponering som følge af EPS-relaterede bivirkninger forekom sjældent.
English: Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 4.5).
Danish: Samtidig administration af kraftige eller moderate CYP3A4-hæmmere (se pkt.
English: Reagila 3 mg, 4.5 mg and 6 mg hard capsules contain Allura red AC (E 129), which may cause allergic reactions.
Danish: Reagila hårde kapsler med 3 mg, 4,5 mg og 6 mg indeholder Allura red AC (E129), som kan give allergiske reaktioner.
English: In a third multinational placebo controlled study using fixed/flexible doses of 3.0-6.0 mg and 6.0-9.0 mg cariprazine, both cariprazine doses groups showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Danish: I et tredje multinationalt placebo-kontrolleret studie med faste/fleksible doser på 3,0-6,0 mg og 6,0-9,0 mg cariprazin viste begge cariprazin-dosisgrupper statistisk signifikant forbedring for både det primære og det sekundære endepunkt i forhold til placebo.
English: Patients with an established diagnosis of diabetes mellitus or patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should be monitored for serum glucose levels.
Danish: Serumglukose skal overvåges hos patienter med en bekræftet diabetes mellitus-diagnose eller patienter med risikofaktorer for diabetes mellitus (f.eks. adipositas eller diabetes i familien), som indleder behandling med atypiske antipsykotika.
English: In the cariprazine clinical studies the incidence of ALT, AST elevation ADRs occurred in 2.2% of cariprazine-, 1.6% of risperidone- and 0.4% of placebo-treated patients.
Danish: I de kliniske studier af cariprazin forekom der bivirkninger med forhøjet ALAT/ASAT hos 2,2 % af de patienter, der fik cariprazin, 1,6 % af de patienter, der fik risperidon og 0,4 % af de patienter, der fik placebo.
English: Titanium dioxide (E 171) Propylene glycol Simeticone
Danish: Titandioxid (E171) Propylenglycol Simeticon
English: Women of childbearing potential must use highly effective contraception while taking Reagila and for at least 10 weeks after stopping treatment.
Danish: Kvinder i den fødedygtige alder skal bruge en meget effektiv prævention, mens de tager Reagila og i mindst 10 uger efter behandlingens afslutning.
English: In rat studies lower female fertility and conception indices were observed (see section 5.3).
Danish: I rottestudier er der blevet observeret lavere fertilitets- og konceptionsindekser hos hunner (se pkt.
English: Therefore, co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole verapamil) is contraindicated (see section 4.3).
Danish: Derfor er samtidig administration af cariprazin og kraftige eller moderate CYP3A4hæmmere (f.eks. boceprevir, clarithromycin, cobicistat, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, posaconazol, ritonavir, saquinavir, telaprevir, telithromycin, voriconazol, diltiazem, erythromycin, fluconazol, verapamil) kontraindiceret (se pkt.
English: Women of childbearing potential must use effective contraception during Reagila treatment.
Danish: Kvinder i den fødedygtige alder skal bruge effektiv prævention, mens de er i behandling med Reagila.
English: Alcohol should be avoided when taking Reagila.
Danish: Du må ikke indtage alkohol, mens du tager Reagila.
English: 2Akathisia: Akathisia, Psychomotor hyperactivity, Restlessness 3Parkinsonism: Akinesia, Bradykinesia, Bradyphrenia, Cogwheel rigidity, Extrapyramidal disorder, Gait disturbance, Hypokinesia, Joint stiffness, Tremor, Masked facies, Muscle rigidity, Musculoskeletal stiffness, Nuchal rigidity, Parkinsonism
Danish: 2Akatisi: Akatisi, psykomotorisk hyperaktivitet, rastløshed 3Parkinsons sygdom: Akinesi, bradykinesi, bradyfreni, tandhjulsrigiditet, ekstrapyramidal forstyrrelse, gangforstyrrelse, hypokinesi, ledstivhed, tremor, maskeansigt, muskelrigiditet, muskel- og knoglestivhed, nakkestivhed, Parkinsons sygdom
English: - if you are taking medicines used to treat: hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir) bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin and nafcillin) tuberculosis (medicines containing rifampicin)
Danish: - hvis du tager lægemidler til behandling af: leverbetændelse, som skyldes hepatitis C-virus (lægemidler, som indeholder boceprevir eller telaprevir) bakterieinfektioner (lægemidler, som indeholder clarithromycin, telithromycin, erythromycin eller nafcillin) tuberkulose (lægemidler, som indeholder rifampicin) hiv-infektioner (lægemidler, som indeholder cobicistat, indinavir, nelfinavir, ritonavir,
English: Black iron oxide (E 172) Propylene glycol Potassium hydroxide
Danish: Sort jernoxid (E172) Propylenglycol Kaliumhydroxid
English: ° abnormal sodium level in the blood
Danish: ° unormalt indhold af natrium i blodet
English: Cariprazine has not been evaluated in patients with severe (CrCl < 30 mL/min) renal impairment (see section 4.2).
Danish: Cariprazin er ikke blevet undersøgt hos patienter med svært (CrCl < 30 ml/min) nedsat nyrefunktion (se pkt.
English: If you are using hormonal contraceptives a so-called barrier method(e.g. condom or diaphragm) should also be used.
Danish: Hvis du bruger hormonprævention, skal du også bruge en såkaldt barrieremetode (f.eks. kondom eller pessar).
English: If you have taken more Reagila than your doctor has recommended or if, for example, a child has taken it by mistake, contact your doctor or go to the nearest hospital right away and take the pack of the medicine with you.
Danish: Hvis du har taget mere Reagila, end din læge har anbefalet, eller hvis f.eks. et barn har taget det ved en fejl, skal du kontakte lægen eller den nærmeste akutmodtagelse og tage medicinbeholderen med. Du kan blive svimmel på grund af lavt blodtryk, få uregelmæssig hjerterytme, føle dig søvnig eller træt, få unormale kropsbevægelser og have problemer med at stå og gå.
English: Gastrooesopha geal reflux disease
Danish: Gastroøsofagea l reflukssygdom
English: ° increases in the level of creatine phosphokinase in the blood
Danish: ° øget indhold af kreatinfosfokinase i blodet
English: Change LS mean (SE)
Danish: LSmiddelændring (SE)
English: In the long term maintenance of effect study, there was no clinically relevant difference in change of body weight from baseline to end of treatment (1.1 kg for cariprazine and 0.9 kg for placebo).
Danish: I de kortvarige studier var der en lidt større gennemsnitlig stigning i legemsvægt i cariprazin-gruppen i forhold til placebogruppen, hhv. 1 kg og 0,3 kg. I det langvarige studie vedrørende fastholdelse af virkning var der ikke nogen klinisk relevant forskel i ændring i legemsvægt fra baseline til afslutning af behandlingen (1,1 kg for cariprazin og 0,9 kg for placebo).