natgillin/translations-raw huggingface dataset:
What Incresync looks like and contents of the pack - Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/30” printed in grey ink on one side. 
Kako Incresync izgleda i sadržaj pakiranja - Incresync 25 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete boje breskve, s oznakama „A/P“ i „25/30“ otisnutim sivom tintom na jednoj strani.
Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone 
Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete alogliptin/pioglitazon
INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg 
16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/30 mg
INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg 
16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/45 mg
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%). 
Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) naspram usporednog lijeka (1,5%).
Slight changes in cell counts may show up in blood tests. 
U krvnim nalazima su moguća manja odstupanja u broju stanica.
Effects of alogliptin on other medicinal products 
Učinci alogliptina na druge lijekove
INFORMATION IN BRAILLE Incresync 25 mg/30 mg 
16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/30 mg
Mean change from baseline in HbA1c (%)† (SE) 
Srednja promjena od početne vrijednosti HbA1c (%) (SE)
Incresync is used to lower blood sugar levels in adults with type 2 diabetes. 
Incresync je koristi za snižavanje razina šećera u krvi u odraslih bolesnika sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 zove se i inzulin neovisni dijabetes melitus.
Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4). 
Prije početka liječenja i povremeno tijekom liječenja Incresyncom preporučuje se procijeniti funkciju bubrega (vidjeti dio 4.4).
Your weight should be checked at regular intervals; if your weight increases, tell your doctor. 
Ako Vam se tjelesna težina poveća, obavijestite o tome liječnika.
LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values 
PPS = bolesnici koji su završili ispitivanje po protokolu (engl. per protocol set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) * Dokazana je statistička neinferiornost i superiornost
Warnings and precautions Talk to your doctor or pharmacist before taking Incresync: - if you have type 1 diabetes (your body does not produce insulin). 
• ako imate šećernu bolest tipa 1 (tijelo ne stvara inzulin)
There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. 
Nakon stavljanja lijeka u promet bilo je prijava slučajeva zatajenja srca kada se pioglitazon primjenjivao ili u bolesnika sa zatajenjem srca u anamnezi ili u kombinaciji s inzulinom.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Tablete Incresync sadrže laktozu i stoga se ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze i galaktoze.
• The package leaflet 
• zamućen ili iskrivljen vid
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting. 
Nakon stavljanja lijeka u promet bilo je spontano prijavljenih nuspojava akutnog pankreatitisa.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). 
Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) naspram onih liječenih usporednim lijekom (2,1%).
Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4) 
• Postojeći ili rak mokraćnog mjehura u anamnezi (vidjeti dio 4.4)
Placental transfer of alogliptin occurs in rats. 
U štakora alogliptin prolazi posteljicu.
Incresync 25 mg/45 mg film-coated tablets 
Incresync 25 mg/45 mg filmom obložene tablete
Musculoskeletal and connective tissues disorders myalgia common fracture bone common 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Prijelom kosti
NN: 
Nepoznato:
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medicinal product dose. 
U skupini liječenoj s 25 mg alogliptina klinički značajna sniženja HbA1c također su opažena bez obzira na osnovnu terapijsku dozu.
Incresync 25 mg/30 mg film-coated tablets 
Incresync 25 mg/30 mg filmom obložene tablete
and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively). 
Ukupna incidencija epizoda teške hipoglikemije bila je usporediva u bolesnika liječenih s 25 mg alogliptina ili 12,5 mg alogliptina, te niža od incidencije u bolesnika liječenih aktivnom kontrolom ili placebom (0,1%, 0,1%, 0,4% i 0,4%, istim redoslijedom).
- Incresync 25 mg/45 mg film-coated tablets (tablets) are red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/45” printed in grey ink on one side. 
- Incresync 25 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete crvene boje, s oznakama „A/P“ i „25/45“ otisnutim sivom tintom na jednoj strani.
25 mg/30 mg film-coated tablets 
25 mg/30 mg filmom obložene tablete
Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin. 
Nakon stavljanja alogliptina u promet također su primljene prijave slučajeva poremećaja funkcije jetre uključujući zatajenje jetre.
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone. 
Svaka filmom obložena tableta od 25 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
12.5 mg/45 mg film-coated tablets 
12,5 mg/45 mg filmom obložene tablete
12.5 mg/30 mg film-coated tablets 
12,5 mg/30 mg filmom obložene tablete
Printing ink 12.5 mg/30 mg film-coated tablets 
Tinta za označavanje 12,5 mg/30 mg filmom obložene tablete
- Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/30” printed in red ink on one side. 
- Incresync 12,5 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete svijetle boje breskve, s oznakama „A/P“ i „12.5/30“ otisnutim crvenom tintom na jednoj strani.
Incresync 12.5 mg/30 mg film-coated tablets 
Incresync 12,5 mg/30 mg filmom obložene tablete
Each 12.5 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone. 
Svaka filmom obložena tableta od 12,5 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
- Incresync 12.5 mg/45 mg film-coated tablets (tablets) are pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/45” printed in red ink on one side. 
- Incresync 12,5 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete blijedo crvene boje, s oznakama „A/P“ i „12.5/45“ otisnutim crvenom tintom na jednoj strani.
Diabetic ketoacidosis 
Gastroezofagealni refluks
Incresync 12.5 mg/45 mg film-coated tablets 
Incresync 12,5 mg/45 mg filmom obložene tablete
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known 
Poremećaji jetre i žuči Poremećaj funkcije jetre uključujući zatajenje jetre
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone 
NAZIV LIJEKA Incresync 25 mg/30 mg tablete alogliptin/pioglitazon
Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone. 
Svaka filmom obložena tableta od 25 mg/30 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 30 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone. 
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. 
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 30 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone. 
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride). 
Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 45 mg pioglitazona (u obliku pioglitazonklorida)
Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke] 
Primarni kompozitni ishod [prvi događaj KV smrti, IM bez smrtnog ishoda i moždanog udara bez smrtnog ishoda] Kardiovaskularna smrt* Infarkt miokarda bez smrtnog ishoda Moždani udar bez smrtnog ishoda 29 (1,1)
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone 
NAZIV LIJEKA Incresync 12,5 mg/45 mg tablete alogliptin/pioglitazon
Pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/45” printed in red ink on one side. 
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete, blijedo crvene boje s oznakama „A/P“ i „12,5/45“ otisnutim crvenom tintom na jednoj strani.
Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side. 
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete boje breskve s oznakama „A/P“ i „12,5/30“ otisnutim crvenom tintom na jednoj strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride). 
Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 30 mg pioglitazona (u obliku pioglitazonklorida)
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone 
NAZIV LIJEKA Incresync 12,5 mg/30 mg tablete alogliptin/pioglitazon
Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side. 
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete crvene boje s oznakama „A/P“ i „25/45“ otisnutim sivom tintom na jednoj strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride). 
Jedna tableta sadrži 25 mg alogliptina (u obliku alogliptinbenzoata) i 45 mg pioglitazona (u obliku pioglitazonklorida)
Nervous system disorders headache common common hypoaesthesia common insomnia uncommon 
Poremećaji živčanog sustava Hipoestezija
Treatment-corrected change from baseline in HbA1c (%)† 
Promjena od početne vrijednosti HbA1c korigirana za liječenje (1-strani CI)
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone 
NAZIV GOTOVOG LIJEKA Incresync 25 mg/45 mg tablete alogliptin/pioglitazon
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone. 
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 30 mg pioglitazona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride). 
Jedna tableta sadrži 25 mg alogliptina (u obliku alogliptinbenzoata) i 30 mg pioglitazona (u obliku pioglitazonklorida)
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. 
Svaka filmom obložena tableta od 12,5 mg/30 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 30 mg pioglitazona.
Uncommon (may affect up to 1 in 100 people): - Symptoms of bladder cancer including blood in your urine, pain when urinating or a sudden need to urinate. 
• Simptomi raka mokraćnog mjehura uključujući krv u mokraći, bol pri mokrenju ili neodgodivu potrebu za mokrenjem.
Placebo-corrected change from baseline in HbA1c (%)† 
Promjena od početne vrijednosti HbA1c (%) korigirana za placebo (2-strani 95% CI)
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate. 
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, laktoza hidrat, hipromeloza, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), makrogol 8000, šelak, karnauba vosak i glicerolmonooleat.
Renal impairment 
Učestalost nuspojava
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, laktoza hidrat, hipromeloza, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side. 
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete boje breskve s oznakama „A/P“ i „25/30“ otisnutim sivom tintom na jednoj strani.
In particular tell your doctor or pharmacist if you are taking any of the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) 
• rifampicin (koristi se za liječenje tuberkuloze i drugih infekcija).
Magyarország Takeda Pharma Kft. Tel: +361 2707030 
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234722722
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone 
Incresync 25 mg/45 mg filmom obložene tablete alogliptin/pioglitazon
Hepatic impairment 
• glavobolja
EU/1/13/842/001 10 film-coated tablets EU/1/13/842/002 14 film-coated tablets EU/1/13/842/003 28 film-coated tablets EU/1/13/842/004 30 film-coated tablets EU/1/13/842/005 56 film-coated tablets EU/1/13/842/006 60 film-coated tablets EU/1/13/842/007 90 film-coated tablets EU/1/13/842/008 98 film-coated tablets EU/1/13/842/009 100 film-coated tablets 
EU/1/13/842/001 10 filmom obloženih tableta EU/1/13/842/002 14 filmom obloženih tableta EU/1/13/842/003 28 filmom obloženih tableta EU/1/13/842/004 30 filmom obloženih tableta EU/1/13/842/005 56 filmom obloženih tableta EU/1/13/842/006 60 filmom obloženih tableta EU/1/13/842/007 90 filmom obloženih tableta EU/1/13/842/008 98 filmom obloženih tableta EU/1/13/842/009 100 filmom obloženih tableta
Takeda Pharma AS Tel: +372 6177 669 
Takeda Pharma AS Tel: ++372 6177 669 info@nycomed.ee
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, laktoza hidrat, hipromeloza, talk, titanijev dioksid (E171), crveni željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
EU/1/13/842/019 10 film-coated tablets EU/1/13/842/020 14 film-coated tablets EU/1/13/842/021 28 film-coated tablets EU/1/13/842/022 30 film-coated tablets EU/1/13/842/023 56 film-coated tablets EU/1/13/842/024 60 film-coated tablets EU/1/13/842/025 90 film-coated tablets EU/1/13/842/026 98 film-coated tablets EU/1/13/842/027 100 film-coated tablets 
EU/1/13/842/019 10 filmom obloženih tableta EU/1/13/842/020 14 filmom obloženih tableta EU/1/13/842/021 28 filmom obloženih tableta EU/1/13/842/022 30 filmom obloženih tableta EU/1/13/842/023 56 filmom obloženih tableta EU/1/13/842/024 60 filmom obloženih tableta EU/1/13/842/025 90 filmom obloženih tableta EU/1/13/842/026 98 filmom obloženih tableta EU/1/13/842/027 100 filmom obloženih tableta
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone 
Incresync 25 mg/30 mg filmom obložene tablete alogliptin/pioglitazon
The overall incidence of episodes of severe hypoglycaemia was comparable in patients treated with 25 mg alogliptin or 12.5 mg alogliptin, 
Najčešća nuspojava u bolesnika liječenih s 25 mg alogliptina bila je glavobolja.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
DODATAK II A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
EU/1/13/842/010 10 film-coated tablets EU/1/13/842/011 14 film-coated tablets EU/1/13/842/012 28 film-coated tablets EU/1/13/842/013 30 film-coated tablets EU/1/13/842/014 56 film-coated tablets EU/1/13/842/015 60 film-coated tablets EU/1/13/842/016 90 film-coated tablets EU/1/13/842/017 98 film-coated tablets EU/1/13/842/018 100 film-coated tablets 
EU/1/13/842/010 10 filmom obloženih tableta EU/1/13/842/011 14 filmom obloženih tableta EU/1/13/842/012 28 filmom obloženih tableta EU/1/13/842/013 30 filmom obloženih tableta EU/1/13/842/014 56 filmom obloženih tableta EU/1/13/842/015 60 filmom obloženih tableta EU/1/13/842/016 90 filmom obloženih tableta EU/1/13/842/017 98 filmom obloženih tableta EU/1/13/842/018 100 filmom obloženih tableta
Mannitol 
Takeda
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg film-coated tablets alogliptin/pioglitazone 
Incresync 12,5 mg/45 mg filmom obložene tablete alogliptin/pioglitazon
EU/1/13/842/028 10 film-coated tablets EU/1/13/842/029 14 film-coated tablets EU/1/13/842/030 28 film-coated tablets EU/1/13/842/031 30 film-coated tablets EU/1/13/842/032 56 film-coated tablets EU/1/13/842/033 60 film-coated tablets EU/1/13/842/034 90 film-coated tablets EU/1/13/842/035 98 film-coated tablets EU/1/13/842/036 100 film-coated tablets 
EU/1/18/842/028 10 filmom obloženih tableta EU/1/13/842/029 14 filmom obloženih tableta EU/1/13/842/030 28 filmom obloženih tableta EU/1/13/842/031 30 filmom obloženih tableta EU/1/13/842/032 56 filmom obloženih tableta EU/1/13/842/033 60 filmom obloženih tableta EU/1/13/842/034 90 filmom obloženih tableta EU/1/13/842/035 98 filmom obloženih tableta EU/0/00/000/036 100 filmom obloženih tableta
Carnauba wax 
Makularni edem
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets alogliptin/pioglitazone 
Incresync 12,5 mg/30 mg filmom obložene tablete alogliptin/pioglitazon
What is Vizamyl and what is it used for? 
Što je Vizamyl i za što se koristi?
The full EPAR and risk management plan summary for Vizamyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vizamyl nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A later re-analysis looked again at data from the original 68 patients together with results from others who had died after the end of the original study, making a total of 106 patients. 
Kasnija ponovna analiza ponovno je istražila podatke izvornih 68 bolesnika zajedno s rezultatima ostalih bolesnika koji su umrli nakon završetka izvornog ispitivanja, što čini ukupno 106 bolesnika.
What are the risks associated with Vizamyl? 
Koji su rizici povezani s lijekom Vizamyl?
What measures are being taken to ensure the safe and effective use of Vizamyl? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vizamyl?
It is not intended to provide practical advice on how to use Vizamyl. 
Svrha sažetka nije davati praktične savjete o korištenju lijeka Vizamyl.
In this re-analysis most readers could interpret the scans with a sensitivity of around 91% (91% of patients who had plaques were identified) and a specificity of 90% (90% of patients without plaques were correctly rated as not having plaques). 
U ovoj posljednjoj analizi većina osoba koja je očitavala snimke mogla je tumačiti snimke s osjetljivošću od otprilike 91% (91% bolesnika kojima su identificirani plakovi) i specifičnost od 90% (u 90% bolesnika bez plakova ispravno je utvrđeno da nemaju plakova).
In addition, the company that markets Vizamyl will provide access to a training course for all nuclearmedicine physicians expected to use this product in the European Union, in order to ensure accurate and reliable reading of the PET scan images. 
Nadalje, tvrtka koja stavlja lijek u promet Vizamyl omogućit će pristup tečajevima za obuku za sve liječnike nuklearne medicine za koje se očekuje da će koristiti ovaj proizvod u Europskoj uniji, kako bi se osiguralo točno i pouzdano očitavanje slika PET snimaka.
The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vizamyl na snazi u Europskoj uniji od 22. kolovoza 2014.
Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities. 
Vizamyl isporučuje vrlo malu količinu zračenja što predstavlja vrlo mali rizik od raka ili bilo kakvih nasljednih abnormalnosti.
This is a summary of the European public assessment report (EPAR) for Vizamyl. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Vizamyl.
This means that the PET scans correctly identified as positive between 81-93% of the patients who had significant amounts of plaques in their brain. 
To znači da su PET snimke ispravno identificirale pozitivno 81-93% bolesnika koji su imali značajne količine plakova u mozgu.
This is considered a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia. 
To se smatra značajnim poboljšanjem u dijagnosticiranju bolesnika s problemima pamćenja koji se evaluiraju zbog Alzheimerove bolesti i drugih tipova demencije.
Doctors will therefore need to use the scan together with a clinical evaluation. 
Stoga liječnici moraju koristiti snimke zajedno s drugim sredstvima kliničkog ocjenjivanja.
A risk management plan has been developed to ensure that Vizamyl is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vizamyl.