natgillin/translations-raw huggingface dataset:
• The other ingredients are lactose monohydrate, cellulose microcrystalline,maize starch, hydroxypropylcellulose , magnesium stearate, and indigo carmine aluminium lake (E132) (for 5 mg) or iron oxide red (E172) (for 10 mg and 30 mg) or iron oxide yellow (E172) (for 15 mg).
Indigo carmine aliminium lake (E132) (za 5 mg) ili crveni željezov oksid (E172) (za 10 mg i 30 mg) ili žuti željezov oksid (E172) (za 15 mg).
Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Nepoznato žuči hepatitis žutica povišene vrijednosti alanin aminotransferaze (ALT) povišene vrijednosti aspartat aminotransferaze (AST) povišene vrijednosti gama-glutamil transferaze (GGT) povišene vrijednosti alkalne fosfataze
Potential for other medicinal products to affect aripiprazole A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
H2 receptora, smanjuje stopu apsorpcije aripiprazola, ali taj se učinak ne smatra klinički značajnim.
Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced to the recommended dose.
Nakon prekida primjene jakih induktora CYP3A4, doza aripiprazola potrebno je smanjiti na preporučenu dozu.
5 mg: EU/1/15/1045/001- 006, EU/1/15/1045/023 10 mg: EU/1/15/1045/007- 012, EU/1/15/1045/024 15 mg: EU/1/15/1045/013- 018, EU/1/15/1045/025 30 mg: EU/1/15/1045/019- 022, EU/1/15/1045/026
5 mg: EU/1/15/1045/001- 006, EU/1/15/1045/023 10 mg: EU/1/15/1045/007- 012, EU/1/15/1045/024 15 mg: EU/1/15/1045/013- 018, EU/1/15/1045/025
INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
16. PODACI NA BRAILLEOVOM PISMU Aripiprazol Accord 5 mg
Aripiprazole Accord contains lactose
Accord sadrži laktozu
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema,
Poremećaji imunološkog sustava alergijska reakcija (npr. anafilaktička reakcija, angioedem uključujući otečen jezik, edem jezika, edem lica, svrbež i urtikariju)
EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
EU/1/15/1045/017- 30 tableta EU/1/15/1045/018- 100 tableta
How to take Aripiprazole Accord
Kako čuvati Aripiprazol Accord
EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets
EU/1/15/1045/011- 30 tableta EU/1/15/1045/012- 100 tableta
Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
I te za prevenciju nove manične epizode u odraslih osoba s pretežno maničnim epizodama u kojih su prethodne manične epizode odgovorile na liječenje aripiprazolom (vidjeti dio 5.1).
What Aripiprazole Accord tablets contain
Accord tablete sadrže
What Aripiprazole Accord is and what it is used for
Accord i za što se koristi
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %), ekstrapiramidni poremećaj (18,4 %), akatizija (16,0 %) i umor (11,8 %); te često (≥ 1/100, < 1/10) bol u gornjem dijelu abdomena, ubrzan srčani ritam, povećanje tjelesne težine, pojačan tek, trzanje mišića i diskinezija.
Each 30 mg tablet contains 177 mg lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tableta od 30 mg sadrži 177 mg laktoze (u obliku hidrata).
To allow the start of the treatment at a low dose you can use an alternative formulation (oral solutionliquid) more suitable than Aripiprazole Accord.The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Kako bi se omogućio početak liječenja pri niskoj dozi, možete koristiti drugu formulaciju (oralnu otopinu - tekućinu) koja je prikladnija od lijeka Aripiprazol
• cardiovascular diseases (diseases of the heart and circulation),, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
• srčanih i krvožilnih bolesti, srčanih ili krvožilnih bolesti u obitelji, moždanog udara ili „mini“
Schizophrenia: the recommended starting dose for Aripiprazole Accord is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Accord je 10 ili 15 mg/dan uz dozu održavanja od 15 mg/dan koja se primjenjuje jedanput dnevno neovisno o obrocima.
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• serotoninski sindrom (reakcija koje može dovesti do osjećaja velike sreće, omamljenosti,
Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10-17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score  20 at baseline.
I u djece i adolescenata Aripiprazol se ispitivao u 30-tjednom placebom kontroliranom ispitivanju u kojem je sudjelovalo 296 djece i adolescenata (10-17 godina) koji su zadovoljavali DSM-IV kriterije za bipolarni poremećaj tipa
In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
U dva dugotrajna ispitivanja u adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom i u bolesnika s bipolarnim poremećajem liječenih aripiprazolom, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 37,0 %, a u mladića (< 2 ng/ml) 59,4 %.
Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tableta od 15 mg sadrži 88 mg laktoze (u obliku hidrata).
Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tableta od 10 mg sadrži 59 mg laktoze (u obliku hidrata).
Hydroxypropylcellulose Magnesium stearate Iron oxide yellow (E172)
Aripiprazol Accord 15 mg tablete laktoza hidrat celuloza, mikrokristalična kukuruzni škrob hidroksipropilceluloza magnezijev stearat željezov oksid, žuti (E172)
Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents 6 to 18 years of age have not yet been established.
Accord u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Manične epizode u bipolarnom poremećaju tipa I U dva trotjedna, placebom kontrolirana ispitivanja monoterapije fleksibilnom dozom u bolesnika s maničnim ili miješanim epizodama bipolarnog poremećaja tipa I, aripiprazol je pokazao nadmoćnu djelotvornost u odnosu na placebo u smanjenju maničnih simptoma tijekom 3 tjedna.
What Aripiprazole Accord tablets looks like and contents of the pack
Kako čuvati Aripiprazol Accord Sadržaj pakiranja i druge informacije
Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tableta od 5 mg sadrži 63 mg laktoze (u obliku hidrata).
It is important that you carry on taking Aripiprazole Accord for as long as your doctor has told you to.
Accord onoliko dugo koliko Vam je to rekao liječnik.
Aripiprazole Accord is for oral use.
Accord je namijenjen za peroralnu primjenu.
Aripiprazole Accord 5/10/15 mg tablets are also available in HDPE bottle with PPCRC closure containing 30 or 100 tablets.
Aripiprazol Accord 5/10/15 mg tablete također su dostupne u HDPE boci s PPCRC čepom koja sadrži
Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole.
Aripiprazol Accord 30 mg tablete: Jedna tableta sadrži 30 mg aripiprazola.
In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
U sporih CYP2D6 metabolizatora, istodobna uporaba jakih inhibitora CYP3A4 može rezultirati višim koncentracijama aripiprazola u plazmi u odnosu na one u brzih CYP2D6 metabolizatora.
Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Shizofrenija u adolescenata u dobi od 15 godina i starijih U kratkotrajnom placebom kontroliranom kliničkom ispitivanju u kojem su sudjelovala 302 adolescenta (13-17 godina) sa shizofrenijom, učestalost i vrsta nuspojava bile su slične onima u odraslih, osim što su sljedeće nuspojave bile prijavljene češće u adolescenata koji su primali aripiprazol nego u odraslih koji su primali aripiprazol (i češće nego uz placebo): Somnolencija/sedacija i ekstrapiramidni poremećaji bili su prijavljeni vrlo često (≥ 1/10), dok su često bili prijavljeni suha usta, pojačan apetit i ortostatska hipotenzija (≥ 1/100, < 1/10).Sigurnosni profil u 26-tjednom otvorenom produžetku ispitivanja bio je sličan onome opaženom u kratkotrajnom, placebom kontroliranom ispitivanju.
Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Aripiprazol Accord 15 mg tablete su žute, okrugle, bikonveksne neobložene tablete ukošene na rubovima, promjera oko 7,14 mm s utisnutom oznakom „A15“ na jednoj strani i bez oznake na drugoj strani.
Aripiprazole Accord 30 mg tablets
Aripiprazol Accord 30 mg tablete
Hydroxypropylcellulose Magnesium stearate Iron oxide red (E172)
Aripiprazol Accord 10 mg/ 30 mg tablete laktoza hidrat celuloza, mikrokristalična kukuruzni škrob hidroksipropilceluloza magnezijev stearat željezov oksid, crveni (E172)
• uncontrollable excessive shopping
- pretjerano kupovanje ili trošenje koje se ne može kontrolirati,
Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents aged below 18 years have not yet been established.
Razdražljivost povezana s autističnim poremećajem: Sigurnost i djelotvornost lijeka Aripiprazol
Aripiprazole Accord 10 mg tablets
Aripiprazol Accord 10 mg tablete
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
EU/1/15/1045/005- 30 tableta EU/1/15/1045/006- 100 tableta
Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Opći poremećaji i reakcije na mjestu primjene umor poremećaj regulacije tjelesne temperature (npr. hipotermija, pireksija) bol u prsištu periferni edem
Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Accord is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Accord je 15 mg i primjenjuje se jedanput dnevno neovisno o obrocima u obliku monoterapije ili kombinirane terapije (vidjeti dio 5.1).
Aripiprazole Accord 15 mg tablets
Aripiprazol Accord 15 mg tablete
Aripiprazole Accord 5 mg tablets
Aripiprazol Accord 5 mg tablete
Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Aripiprazol Accord 5 mg tablete: Jedna tableta sadrži 5 mg aripiprazola.
Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Aripiprazol Accord 10 mg tablete: Jedna tableta sadrži 10 mg aripiprazola.
Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Aripiprazol Accord 15 mg tablete: Jedna tableta sadrži 15 mg aripiprazola.
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.U populaciji adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 25,6 %, a u mladića (< 2 ng/ml) 45,0 %.
QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole.
KVALITATIVNI I KVANTITATIVNI SASTAV Aripiprazol Accord 5 mg tablete
Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting
Poremećaji probavnog sustava konstipacija dispepsija mučnina hipersekrecija sline povraćanje pankreatitis disfagija proljev nelagoda u abdomenu nelagoda u želucu
Lactose monohydrate Cellulose, microcrystalline Maize starch
Aripiprazol Accord 5 mg tablete laktoza hidrat celuloza, mikrokristalična kukuruzni škrob hidroksipropilceluloza magnezijev stearat boja
Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Aripiprazol Accord 10 mg tablete su ružičaste, bikonveksne neobložene tablete modificiranog pravokutnog oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A10“ na jednoj strani i bez oznake na drugoj strani.
Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Accord tablete izgledaju i sadržaj pakiranja Aripiprazol Accord 5 mg tablete su plave, bikonveksne neobložene tablete modificiranog pravokutnog oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A5“ na jednoj strani i bez oznake na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Accord 30 mg tablete aripiprazol
Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Ružičaste, okrugle, bikonveksne neobložene tablete ukošene na rubovima, promjera oko 9,1 mm s utisnutom oznakom „A30“ na jednoj strani i bez oznake na drugoj strani.
Do not take Aripiprazole Accord
Pokušajte uzimati Aripiprazol
Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Žute, okrugle, bikonveksne neobložene tablete ukošene na rubovima, promjera oko 7,14 mm s utisnutom oznakom „A15“ na jednoj strani i bez oznake na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Accord 5 mg tablete aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Accord 10 mg tablete aripiprazol
Renal impairment
Što Aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Accord 15 mg tablete aripiprazol
Talk to your doctor before taking Aripiprazole Accord
Upozorenja i mjere opreza Obratite se svom liječniku prije nego što uzmete Aripiprazol
Grand mal convulsion Serotonin syndrome Speech disorder
Poremećaji živčanog sustava akatizija ekstrapiramidalni poremećaj tremor glavobolja sedacija somnolencija omaglica tardivna diskinezija distonija neuroleptički maligni sindrom (NMS) konvulzije tipa grand mal serotoninski sindrom poremećaj govora
EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
EU/1/15/1045/019 14x1 tableta EU/1/15/1045/020 28x1 tableta EU/1/15/1045/026 49x1 tableta EU/1/15/1045/021 56x1 tableta EU/1/15/1045/022 98x1 tableta
EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
EU/1/15/1045/001 14x1 tableta EU/1/15/1045/002 28x1 tableta EU/1/15/1045/023 49x1 tableta EU/1/15/1045/003 56x1 tableta EU/1/15/1045/004 98x1 tableta
EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
EU/1/15/1045/013 14x1 tableta EU/1/15/1045/014 28x1 tableta EU/1/15/1045/025 49x1 tableta EU/1/15/1045/015 56x1 tableta EU/1/15/1045/016 98x1 tableta
Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Ružičaste, bikonveksne neobložene tablete modificiranog pravokutnog oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A10“ na jednoj strani i bez oznake na drugoj strani.
EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
EU/1/15/1045/007 14x1 tableta EU/1/15/1045/008 28x1 tableta EU/1/15/1045/024 49x1 tableta EU/1/15/1045/009 56x1 tableta EU/1/15/1045/010 98x1 tableta
Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Shizofrenija u adolescenata u dobi od 15 i više godina: preporučena doza za Aripiprazol
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
generalizirani anksiozni poremećaj, opsesivno kompulzivni poremećaj (OKP) i socijalnu fobiju,
Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
I u adolescenata u dobi od 13 godina i starijih tijekom najdulje 12 tjedana (vidjeti dio 5.1).
Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Plave, bikonveksne neobložene tablete modificiranog pravokutnog oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A5“ na jednoj strani i bez oznake na drugoj strani.
Breast-feeding
Aripiprazol
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
TVARI Jedna tableta sadrži 5 mg aripiprazola.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
TVARI Jedna tableta sadrži 10 mg aripiprazola.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
TVARI Jedna tableta sadrži 30 mg aripiprazola.
Gastrointestinal disorders
Nepoznato trombocitopenija
Posology
Prolaktin
11 April 2012
20. prosinca 2013.
EMEA/H/C/000255/W
EMEA/H/C/000169/WS/355 EMEA/H/C/000255/WS/355
es this withdrawal have for patients in clinical trials?
Koje posljedice ima ovo povlačenje za pacijente u kliničkim ispitivanjima?
a clinical trial and need more information about your treatment, contact the doctor who is
Ako sudjelujete u kliničkom ispitivanju te Vam je potrebno više informacija o Vašem liječenju, obratite se liječniku koji Vam pruža liječenje.
What was the recommendation of the CHMP at that tim
Koja je bila preporuka CHMP-a u tom trenutku?
The full European Public Assessment Report for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjelovito europsko javno izvješće o procjeni lijeka Prometax može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax.
Tvrtka je obavijestila CHMP da nema posljedica za pacijente koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi Exelon ili Prometax.
The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Cjelovito europsko javno izvješće o procjeni lijeka Exelon može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Exelon and Prometax are medicines containing the active substance rivastigmine.
Exelon i Prometax su lijekovi koji sadrže djelatnu tvar rivastigmin.
The withdrawal letter can be found here.
Dopis tvrtke kojim se obavještava Agenciju o povlačenju zahtjeva dostupan je ovdje.
The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Kapsule i oralne otopine mogu se također koristiti za liječenje blage do umjereno teške demencije u pacijenata s Parkinsonovom bolešću.
What are Exelon and Prometax?
Što su Exelon i Prometax?
This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Zahtjev je povučen nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour.
Svi oblici lijekova mogu se koristiti za liječenje pacijenata s blagom do umjereno teškom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other).
U pacijenata s Alzheimerovom bolešću određene živčane stanice umiru u mozgu što rezultira niskim razinama neurotransmitera acetilkolina (tvari koja omogućava živčanim stanicama međusobnu komunikaciju).
There are no consequences on the use of Exelon and Prometax in their author
Nema posljedica za korištenje lijekova Exelon i Prometax u njihovim odobrenim indikacijama.
The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl
Djelatna tvar u lijekovima Exelon i Prometax, rivastigmin djeluje blokadom enzima koji razgrađuju acetilkolin: acetilkolinesteraze i butirilkolinesteraze.
What is happening with Exelon and Prometax in their authorised ised indications.
Što se događa s lijekovima Exelon i Prometax kada je riječ o korištenju u njihovim odobrenim indikacijama?
uated the er the CHMP had o the questions, there were still some unresolved issues.
Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su uvijek postojale neke nedoumice.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks.
Sukladno navedenome, u vrijeme povlačenja, CHMP je smatrao kako koristi transdermalnih flastera Exelon/Prometax u liječenju pacijenata s teškom Alzheimerovom demencijom ne nadmašuju s njima povezane rizike.