FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin monotherapy and post-marketing experience
Danish: Bivirkningsfrekvens identificeret i placebokontrollerede kliniske undersøgelser med sitagliptin-monoterapi og efter markedsføring
English: In addition, patients should be alerted to the risk of hypoglycaemia when TESAVEL is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienterne være opmærksomme på risikoen for hypoglykæmi, når TESAVEL anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Danish: TESAVEL er også indiceret som tillægsbehandling til insulin (med eller uden metformin), når diæt og motion plus stabil dosering af insulin ikke giver tilstrækkelig glykæmisk kontrol.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får TESAVEL (se punkt 4).
English: No dose adjustment for TESAVEL is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Danish: Dosisjustering af TESAVEL er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
English: Do not take TESAVEL - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6)
Danish: Tag ikke TESAVEL - hvis De er allergisk over for sitagliptin eller et af de øvrige indholdsstoffer i TESAVEL
English: Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Danish: Behandling med GLP-1 eller DPP-4-hæmmere i dyremodeller af type 2-diabetes har vist sig at forbedre betacellernes reaktion på glucose og at stimulere syntesen samt frigivelsen af insulin.
English: TESAVEL has no or negligible influence on the ability to drive and use machines.
Danish: TESAVEL påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Ask your pharmacist how to throw away medicines no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: What you need to know before you take TESAVEL
Danish: Det skal De vide, før De begynder at tage TESAVEL
English: HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Danish: HbA1c resultater i placebokontrollerede monoterapi-og kombinationsterapiundersøgelser*
English: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation
Danish: Meget almindelig (kan berøre flere end 1 ud af 10) : Lavt blodsukker.
English: If you take more TESAVEL than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Danish: Hvis De har taget for meget TESAVEL Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
English: TESAVEL should not be used during breast-feeding.
Danish: TESAVEL bør ikke anvendes under amning.
English: as dual oral therapy in combination with
Danish: som dual oral terapi sammen med
English: TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Danish: TESAVEL tilhører en klasse af orale anti-hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase-4-(DPP-4)-hæmmere.
English: When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når TESAVEL anvendes i kombination med et sulfonylurinstof eller sammen med insulin, kan en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
English: However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.
Danish: Når lægemidlet tages sammen med et sulfonylurinstof eller sammen med insulin kan lavt blodsukker (hypoglykæmi) forekomme.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TESAVEL in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med TESAVEL hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
Danish: Til patienter med svær nyreinsufficiens (GFR ≥15 til <30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR <15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg TESAVEL en gang dagligt.
English: TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Danish: TESAVEL er ikke undersøgt hos patienter med svær leverinsufficiens, og der bør udvises forsigtighed (se pkt.
English: If a hypersensitivity reaction is suspected, TESAVEL should be discontinued.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Tesavel seponeres.
English: How to take TESAVEL
Danish: Sådan skal De tage TESAVEL
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om TESAVEL findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
Danish: Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg TESAVEL en gang dagligt.
English: as triple oral therapy in combination with
Danish: som tripel oral behandling terapi sammen med
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas
Danish: STOP med at tage TESAVEL og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger: Svære og vedvarende smerter i maven, som kan stråle ud i ryggen, med eller uden kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pankreatitis).
English: TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Danish: TESAVEL indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP-4-hæmmere (dipeptylpeptidase-4-hæmmere).
English: Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Danish: Behandling med sitagliptin 100 mg en gang dagligt som monoterapi gav signifikante forbedringer i HbA1c, i faste-plasma-glucose, (FPG) og 2-timers postprandial glucose (2-timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvoraf den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
English: After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (PerProtocol Analysis).
Danish: Efter 54 uger var den gennemsnitlige reduktion i forhold til baseline i HbA1c -0,76% med sitagliptin og -0,64% med glipizid (Per Protocol Analysis).
English: If bullous pemphigoid is suspected, TESAVEL should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal TESAVEL seponeres.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Danish: Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af TESAVEL som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist).
English: Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Danish: Nogle patienter har oplevet følgende bivirkninger, efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning.
English: Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
Danish: MSD Α.Φ.Β.Ε.Ε Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com
English: For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control:
Danish: TESAVEL er indiceret til at forbedre den glykæmiske kontrol:
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Danish: For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR <45 ml/min samt ESRD-patienter med behov for hæmodialyse eller peritonealdialyse have lavere doser (se pkt.
English: What TESAVEL is and what it is used for What you need to know before you take TESAVEL How to take TESAVEL
Danish: Det skal De vide, før De begynder at tage TESAVEL Sådan skal De tage TESAVEL Bivirkninger
English: Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
Danish: De kliniske data der er beskrevet nedenfor tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administrres samtidigt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med TESAVEL Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
Danish: Peakplasmakoncentrationer (median Tmax) forkeom 1-4 timer efter dosering, gennemsnitlig plasma-AUC for sitagliptin var 8,52 µM•hr, Cmax var 950 nM. Sitagliptins absolutte biotilgængelighed er ca. 87%.
English: TESAVEL 25 mg tablets Sitagliptin
Danish: TESAVEL 25 mg tabletter sitagliptin
English: TESAVEL 100 mg tablets Sitagliptin
Danish: TESAVEL 100 mg tabletter sitagliptin
English: TESAVEL 50 mg tablets Sitagliptin
Danish: TESAVEL 50 mg tabletter sitagliptin
English: The overall incidence of gastrointestinal adverse reactions considered as drug-related in patients treated with sitagliptin was 2.7 % compared with 12.6 % in patients treated with metformin.
Danish: Reduktionen i HbA1c i forhold til de gennemsnitlige baseline værdier på 7,2% var -0,43% for sitagliptin og -0,57% for metformin (Per Protocol Analysis).Overordnet var incidensen for gastrointestinale bivirkninger, som blev anset for at være lægemiddelrelaterede, 2,7% hos patienter, der fik sitagliptin, sammenlignet med 12,6% hos de patienter, der fik metformin.
English: EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
Danish: EU/1/07/435/013 14 filmovertrukne tabletter EU/1/07/435/014 28 filmovertrukne tabletter EU/1/07/435/023 30 filmovertrukne tabletter EU/1/07/435/015 56 filmovertrukne tabletter EU/1/07/435/016 84 filmovertrukne tabletter EU/1/07/435/024 90 filmovertrukne tabletter EU/1/07/435/017 98 filmovertrukne tabletter EU/1/07/435/018 50 x 1 filmovertrukne tabletter
English: EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
Danish: EU/1/07/435/001 14 filmovertrukne tabletter EU/1/07/435/002 28 filmovertrukne tabletter EU/1/07/435/019 30 filmovertrukne tabletter EU/1/07/435/003 56 filmovertrukne tabletter EU/1/07/435/004 84 filmovertrukne tabletter EU/1/07/435/020 90 filmovertrukne tabletter EU/1/07/435/005 98 filmovertrukne tabletter EU/1/07/435/006 50 x 1 filmovertrukne tabletter
English: EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Danish: EU/1/07/435/007 14 filmovertrukne tabletter EU/1/07/435/008 28 filmovertrukne tabletter EU/1/07/435/021 30 filmovertrukne tabletter EU/1/07/435/009 56 filmovertrukne tabletter EU/1/07/435/010 84 filmovertrukne tabletter EU/1/07/435/022 90 filmovertrukne tabletter EU/1/07/435/011 98 filmovertrukne tabletter EU/1/07/435/012 50 x 1 filmovertrukne tabletter
English: The TECOS was a randomised in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Danish: Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret TESAVEL til Dem personligt.
English: Driving and using machines
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ€
English: TESAVEL 100 mg film-coated tablets Sitagliptin
Danish: TESAVEL 100 mg filmovertrukne tabletter sitagliptin
English: TESAVEL 25 mg film-coated tablets
Danish: TESAVEL 25 mg filmovertrukne tabletter
English: TESAVEL 100 mg film-coated tablets
Danish: TESAVEL 100 mg filmovertrukne tabletter
English: TESAVEL 25 mg film-coated tablets Sitagliptin
Danish: TESAVEL 25 mg filmovertrukne tabletter sitagliptin
English: TESAVEL 50 mg film-coated tablets Sitagliptin
Danish: TESAVEL 50 mg filmovertrukne tabletter sitagliptin
English: TESAVEL 50 mg film-coated tablets
Danish: TESAVEL 50 mg filmovertrukne tabletter
English: Paediatric No studies with TESAVEL have been performed in paediatric patients.
Danish: Børn Der er ikke udført undersøgelser med anvendelse af TESAVEL til børn.
English: What TESAVEL looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Danish: Sitagliptin 100 mg en gang dagligt som supplement til igangværende behandling med pioglitazon + metforminbehandling
English: Pharmaceutical form
Danish: Lægemiddelform Administrati on
English: 1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab
Danish: 1 hætteglas + 1 injektionssprøjte + 1 kanyle + 1 renseserviet
English: 12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
Danish: 12 hætteglas + 72 injektionssprøjter med påsat kanyle + 144 renseservietter
English: 2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
Danish: 2 hætteglas + 12 injektionssprøjter med påsat kanyle + 24 renseservietter
English: 1 vial + 6 injection syringes with attached needle + 12 cleansing swabs
Danish: 1 hætteglas + 6 injektionssprøjter med påsat kanyle + 12 renseservietter
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemidde l¬form
English: Withdrawal period
Danish: Tilbageho ldelsestid
English: Content Package size
Danish: Indhold Pakningsstør relse
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
Danish: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*: A/Brisbane/02/2018 (H1N1)pdm09- lignende stamme (A/Idaho/07/2018) 15 mikrogram HA** A/Kansas/14/2017 (H3N2)- lignende stamme (A/Indiana/08/2018) 15 mikrogram HA** B/Colorado/06/2017 - lignende stamme (B/Iowa/06/2017) 15 mikrogram HA** B/Phuket/3073/2013 - lignende stamme (B/Singapore/INFTT-16-0610/2016) 15 mikrogram HA**
English: --¹ 1 Each 0.5 ml dose contains:
Danish: 1 Hver 0,5 ml-dosis indeholder:
English: * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Danish: * opformeret i Madin Darby Canine Kidney (MDCK)-celler.
English: per 0.5 ml dose
Danish: pr. 0,5 ml-dosis
English: Intramuscular use Pre-filled syringe (glass) without needle
Danish: Fyldt injektionssprøjte (glas) uden kanyle
English: They may also have episodes of depression.
Danish: De kan også have episoder med depression.
English: Aripiprazole Zentiva aripiprazole
Danish: Aripiprazole Zentiva aripiprazol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aripiprazole Zentiva den 25. juni 2015.
English: The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Zentiva anvendes så sikkert som muligt.
English: The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Danish: Udvalget anbefalede, at Aripiprazole Zentiva godkendes til anvendelse i EU.
English: Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Danish: Aripiprazole Zentiva fås som tabletter (5, 10, 15 og 30 mg) og som tabletter, der opløses i munden (smeltetabletter) (10, 15 and 30 mg).
English: Other information about Aripiprazole Zentiva
Danish: Andre oplysninger om Aripiprazole Zentiva
English: In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Danish: Den virksomhed, der markedsfører Aripiprazole Zentiva, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Danish: • bipolar lidelse type I, en psykisk sygdom, hvor patienterne skiftevis har episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør.
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.
Danish: Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Zentiva i kroppen.
English: For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Zentiva, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Danish: Aripiprazole Zentiva anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, der tidligere har haft virkning af lægemidlet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
English: Aripiprazole Zentiva is used in patients with the following mental illnesses:
Danish: Aripiprazole Zentiva anvendes hos patienter med følgende psykiske sygdomme:
English: Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Aripiprazole Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: • skizofreni, der er en psykisk sygdom, som giver symptomer bl.a. i form tankeforstyrrelser og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
English: This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Danish: Det betyder, at Aripiprazole Zentiva svarer til et "referencelægemiddel", som allerede er godkendt i EU.
English: The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Aripiprazole Zentiva, aripiprazol, er et antipsykotisk lægemiddel.