natgillin/translations-raw huggingface dataset:
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Üks 25 mg / 45 mg õhukese polümeerikattega tablett sisaldab alogliptiinbensoaati ja pioglitasoonvesinikkloriidi koguses, mis vastab 25 mg alogliptiinile ja 45 mg pioglitasoonile.
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.
Üks 12,5 mg / 45 mg õhukese polümeerikattega tablett sisaldab alogliptiinbensoaati ja pioglitasoonvesinikkloriidi koguses, mis vastab 12,5 mg alogliptiinile ja 45 mg pioglitasoonile.
Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke]
Esmane liittulemusnäitaja [esmakordne kas surm südame-veresoonkonna nähu tagajärjel, surmaga mittelõppenud müokardiinfarkt ja surmaga mittelõppenud insult]
Table 1: Adverse reactions System organ class Adverse reaction
Organsüsteemi klass Kõrvaltoime
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 25 mg alogliptiini (bensoaadina) ja 45 mg pioglitasooni (vesinikkloriidina).
- 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 õhukese polümeerikattega tabletid (tabletid) on punased, ümmargused (ligikaudu 8,7 mm läbimõõduga), kaksikkumerad, õhukese polümeerikattega tabletid, mille ühele küljele on halli värviga trükitud „A/P” ja „25/45”.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the serum concentration of pioglitazone (see section 4.5).
(tsütokroom P450 2C8 indutseerija) põhjustab pioglitasooni seerumkontsentratsiooni suurenemist või vähenemist (vt lõik 4.5).
- 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 õhukese polümeerikattega tabletid (tabletid) on helepunased, ümmargused (ligikaudu 8,7 mm läbimõõduga), kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on punase värviga trükitud „A/P” ja „12.5/45”.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 12,5 mg alogliptiini (bensoaadina) ja 30 mg pioglitasooni (vesinikkloriidina).
Mean levels of liver enzymes decreased with treatment with pioglitazone.
Keskmine maksaensüümide sisaldus vähenes pioglitasoonraviga.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 12,5 mg alogliptiini (bensoaadina) ja 45 mg pioglitasooni (vesinikkloriidina).
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Tiasolidiindioonidega, sealhulgas pioglitasooniga, on turuletulekujärgselt teatatud äsja tekkinud või raskenenud diabeetilisest makulaarsest ödeemist koos nägemisteravuse vähenemisega.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 25 mg alogliptiini (bensoaadina) ja 30 mg pioglitasooni (vesinikkloriidina).
Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Üks 25 mg / 30 mg õhukese polümeerikattega tablett sisaldab alogliptiinbensoaati ja pioglitasoonvesinikkloriidi koguses, mis vastab 25 mg alogliptiinile ja 30 mg pioglitasoonile.
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 25 mg / 45 mg tabletid alogliptiin/pioglitasoon
In studies in vitro, alogliptin was found to be neither a substrate nor an inhibitor of key transporters associated with disposition of the active substance in the kidney: organic anion transporter-1, organic anion transporter-3 or organic cationic transporter-2 (OCT2).
Need transporterid on orgaaniliste anioonide transporter 1 (OAT1), OAT3 ja orgaaniliste katioonide transporter 2 (OCT2).
Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
Uurimata makrohematuuria (vt lõik 4.4).
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 25 mg / 30 mg tabletid alogliptiin/pioglitasoon
- 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 õhukese polümeerikattega tabletid Heledat virsikuvärvi, ümmargused (ligikaudu 8,7 mm läbimõõduga), kaksikkumerad, õhukese polümeerikattega tabletid, mille ühele küljele on punase värviga trükitud „A/P” ja „12.5/30”.
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 12,5 mg / 30 mg tabletid alogliptiin/pioglitasoon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 12,5 mg / 45 mg tabletid alogliptiin/pioglitasoon
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Turuletulekujärgselt on esinenud maksaensüümide suurenenud sisalduse ja hepatotsellulaarse düsfunktsiooni harvad juhud.
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Üks 12,5 mg / 30 mg õhukese polümeerikattega tablett sisaldab alogliptiinbensoaati ja pioglitasoonvesinikkloriidi koguses, mis vastab 12,5 mg alogliptiinile ja 30 mg pioglitasoonile.
Mean change from baseline in HbA1c (%)† (SE)
HbA1c keskmine muutus võrreldes algsega (%) (SE)
Iron oxide red (E172) Iron oxide red (E172) Iron oxide red (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Titaandioksiid (E171) Titaandioksiid (E171) Titaandioksiid (E171) Titaandioksiid (E171) Makrogool 8000
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Maksa ja sapiteede häired maksafunktsiooni häire, sh maksapuudulikkus teadmata
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 õhukese polümeerikattega tabletti EU/1/13/842/002 14 õhukese polümeerikattega tabletti EU/1/13/842/003 28 õhukese polümeerikattega tabletti EU/1/13/842/004 30 õhukese polümeerikattega tabletti EU/1/13/842/005 56 õhukese polümeerikattega tabletti EU/1/13/842/006 60 õhukese polümeerikattega tabletti EU/1/13/842/007 90 õhukese polümeerikattega tabletti EU/1/13/842/008 98 õhukese polümeerikattega tabletti EU/1/13/842/009 100 õhukese polümeerikattega tabletti
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 õhukese polümeerikattega tabletti EU/1/13/842/020 14 õhukese polümeerikattega tabletti EU/1/13/842/021 28 õhukese polümeerikattega tabletti EU/1/13/842/022 30 õhukese polümeerikattega tabletti EU/1/13/842/023 56 õhukese polümeerikattega tabletti EU/1/13/842/024 60 õhukese polümeerikattega tabletti EU/1/13/842/025 90 õhukese polümeerikattega tabletti EU/1/13/842/026 98 õhukese polümeerikattega tabletti EU/1/13/842/027 100 õhukese polümeerikattega tabletti
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/1/13/842/028 10 õhukese polümeerikattega tabletti EU/1/13/842/029 14 õhukese polümeerikattega tabletti EU/1/13/842/030 28 õhukese polümeerikattega tabletti EU/1/13/842/031 30 õhukese polümeerikattega tabletti EU/1/13/842/032 56 õhukese polümeerikattega tabletti EU/1/13/842/033 60 õhukese polümeerikattega tabletti EU/1/13/842/034 90 õhukese polümeerikattega tabletti EU/1/13/842/035 98 õhukese polümeerikattega tabletti EU/1/13/842/036 100 õhukese polümeerikattega tabletti
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 25 mg / 45 mg õhukese polümeerikattega tabletid alogliptiin/pioglitasoon
Film-coating
Kusepõievähk
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 õhukese polümeerikattega tabletti EU/1/13/842/011 14 õhukese polümeerikattega tabletti EU/1/13/842/012 28 õhukese polümeerikattega tabletti EU/1/13/842/013 30 õhukese polümeerikattega tabletti EU/1/13/842/014 56 õhukese polümeerikattega tabletti EU/1/13/842/015 60 õhukese polümeerikattega tabletti EU/1/13/842/016 90 õhukese polümeerikattega tabletti EU/1/13/842/017 98 õhukese polümeerikattega tabletti EU/1/13/842/018 100 õhukese polümeerikattega tabletti
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 25 mg / 30 mg õhukese polümeerikattega tabletid alogliptiin/pioglitasoon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 12,5 mg / 30 mg õhukese polümeerikattega tabletid alogliptiin/pioglitasoon
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg film-coated tablets alogliptin/pioglitazone
RAVIMPREPARAADI NIMETUS Incresync 12,5 mg / 45 mg õhukese polümeerikattega tabletid alogliptiin/pioglitasoon
- 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).
- Teised abiained on mannitool, mikrokristalliline tselluloos, hüdroksüpropüültselluloos, naatriumkroskarmelloos, magneesiumstearaat, laktoosmonohüdraat, hüpromelloos, talk, titaandioksiid (E171), punane raudoksiid (E172), makrogool 8000, šellak ja must raudoksiid (E172).
- 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.
- Teised abiained on mannitool, mikrokristalliline tselluloos, hüdroksüpropüültselluloos, naatriumkroskarmelloos, magneesiumstearaat, laktoosmonohüdraat, hüpromelloos, talk, titaandioksiid (E171), punane raudoksiid (E172), makrogool 8000, šellak, karnaubavaha ja glütseroolmonooleaat.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Rifampitsiini samaaegsel manustamisel võib olla vajalik pioglitasooni annust suurendada.
Vizamyl flutemetamol (
Vizamyl flutemetamool (
A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Vizamyli võimalikult ohutu kasutamine.
What measures are being taken to ensure the safe and effective use of Vizamyl?
Mis meetmed võetakse, et tagada Vizamyli ohutu ja efektiivne kasutamine?
The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Euroopa Komisjon andis Vizamyli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. augustil
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.
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Vizamyli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Vizamyl and what is it used for?
Mis on Vizamyl ja milleks seda kasutatakse?
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.
Hilisemas järelanalüüsis vaadeldi uuesti algse 68 patsiendi andmeid koos nende patsientide tulemustega, kes surid pärast algse uuringu lõppu, kokku 106 patsiendi andmeid.
Why is Vizamyl approved?
Miks Vizamyl heaks kiideti?
What are the risks associated with Vizamyl?
Mis riskid Vizamyliga kaasnevad?
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).
Järelanalüüsis analüüsis enamik arste uuringuid ligikaudu 91% tundlikkusega (tuvastati 91% patsientidest, kellel olid naastud) ja 90% spetsiifilisusega (90% naastudeta patsientidest tuvastati õigesti).
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.
See tähendab, et PET-uuringud tuvastasid õigesti positiivsena 81-93% patsientidest, kelle ajus oli olulises koguses naaste.
β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some older people with no symptoms of dementia.
Beeta-amüloidnaastud on ladestused, mis vahel esinevad patsientide ajus dementsusest (näiteks Alzheimeri tõbi, Lewy kehadega dementsus, Parkinsoni tõvega seotud dementsus) põhjustatud mäluprobleemide korral ja ka mõnedel dementsuse sümptomiteta eakatel.
It is not intended to provide practical advice on how to use Vizamyl.
Hindamisaruandes ei anta Vizamyli kasutamise praktilisi nõuandeid.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vizamyl's benefits are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee otsustas, et Vizamyli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
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.
Lisaks võimaldab Vizamyli turustav ettevõte kõigil nukleaarmeditsiini arstidel, kes seda ravimit Euroopa Liidus kasutada võivad, osaleda koolituskursusel, et tagada PET-kihtülesvõtete täpne ja usaldusväärne hindamine.
The most common side effects with Vizamyl (seen in between 1 and 10 patients in 100) are flushing (reddening of the skin) and increased blood pressure.
Vizamyli kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on punetus (nahapunetus), ja kõrgenenud vererõhk.
Doctors will therefore need to use the scan together with a clinical evaluation.
Seetõttu peavad arstid kasutama PET-kujutisi koos kliinilise hindamisega.
Patients should discuss the results of their PET scan with their doctor.
Patsiendid peavad arutama PET-uuringu tulemusi oma arstiga.
There is, however, a risk of false positive results (when patients without plaques are rated as positive), therefore Vizamyl scans should not be used on their own to diagnose dementia, but together with a clinical evaluation of the patient.
Siiski eksisteerib valepositiivsete tulemuste risk (kui naastuteta patsiendid saavad positiivse diagnoosi), mistõttu ei tohi dementsuse diagnoosimiseks kasutada ainult Vizamyliga tehtud uuringuid, vaid neile peab kaasnema patsiendi kliiniline hindamine.
The type of scan used with Vizamyl is called positron-emission tomography (PET).
Vizamyliga läbiviidavat uuringut nimetatakse positronemissioontomograafiaks (PET).
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Vizamyl.
Inimravimite komitee märkis aga, et Alzheimeri tõve praeguste ravimeetodite vähese efektiivsuse tõttu puuduvad veenvad tõendid patsientide ravimeetodite või nende ravitulemuste viivitamatuks paranemiseks pärast Vizamyli PET-uuringuid.
In terms of safety, Vizamyl involves exposure of the patient to small amounts of radiation, which is in the range of other approved radiopharmaceuticals, and the safety profile is therefore acceptable.
Ohutuse seisukohast kaasneb Vizamyliga patsiendile vähesel määral kiiritust, mis jääb teiste heakskiidetud radiofarmatseutiliste ravimite kiirgusnormi piiresse ning ohutusprofiil on seega vastuvõetav.
Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.
Vizamyl on radiofarmatseutiline ravim (ravim, mis sisaldab väikeses koguses radioaktiivset ainet), mille toimeaine on flutemetamool (18F); see on ette nähtud ainult diagnostiliseks kasutamiseks.
For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet.
Vizamyli kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
Other information about Vizamyl
Muu teave Vizamyli kohta
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.
Seda parandab oluliselt nende mäluprobleemidega patsientide diagnoosimist, kellel uuritakse Alzheimeri tõbe ja teisi dementsuse vorme.
In addition, the usefulness of Vizamyl in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Lisaks ei ole tuvastatud Vizamyli kasulikkust mäluprobleemidega patsientide Alzheimeri tõve arengu prognoosimisel ja patsientide ravivastuse jälgimisel.
If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Kui PET-uuringus ei tuvastata beeta-amüloidnaaste või neid on vähe (negatiivne tulemus), on ebatõenäoline, et patsiendil on Alzheimeri tõbi.
The radiation it emits can be detected on the PET scan, enabling doctors to see whether or not significant amount of plaques are present.
Kiirgust saab tuvastada PET-uuringu kujutisel, mis võimaldab arstidel näha, kas naaste esineb olulises koguses või ei.
The study looked at the sensitivity of the PET scans (how well scans identified patients who had significant amounts of plaques in the brain) when interpreted by skilled readers.
Uuringus vaadeldi PET-uuringu tundlikkust (kui hästi uuring tuvastas patsiendid, kelle ajus oli olulises koguses naaste), kui neid analüüsisid kogenud arstid.
For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Vizamyli kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vizamyl, including the appropriate precautions to be followed by healthcare professionals and patients.
Selle alusel lisati Vizamyli omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
At the end of the study, 68 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Uuringu lõpus tehti 68 patsiendil lahang, et tõendada lõplikult, kas nende ajus oli olulisel arvul beetaamüloidnaaste.
When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%.
Lahangutulemuste võrdlemisel PET-uuringutega selgus, et uuringute tundlikkus oli 8193%.
Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities.
Vizamyli kiirituse kogus on väga väike ja minimaalse vähi- või mis tahes pärilike kõrvalekallete riskiga.
Vizamyl was investigated in one main study in 176 patients nearing the end of their lives who had consented to autopsies when they died, in order to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Vizamyli uuriti ühes põhiuuringus, kus osales 176 kõrges eas patsienti, kes olid andnud nõusoleku surmajärgseks lahkamiseks, et teha lõplikult kindlaks, kas nende ajus on suures koguses beetaamüloidnaaste.
How does Vizamyl work?
Kuidas Vizamyl toimib?
Vizamyl is available as a solution that is given by injection into a vein, about 90 minutes before obtaining an image from a PET scan.
Vizamyli turustatakse lahusena, mida süstitakse veeni umbes 90 minutit enne PET-kujutise tegemist.
The active substance in Vizamyl, flutemetamol (18F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Vizamyli toimeaine flutemetamool (18F) on radiofarmatseutiline ravim, mis emiteerib väikeses koguses kiirgust ja kinnitub ajus olevatele beeta-amüloidnaastudele.
However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen in patients with different types of dementias as well as in older people with no symptoms.
Siiski ei piisa positiivsest tulemusest mäluhäiretega patsiendi diagnoosimiseks, sest naaste võib esineda eri tüüpi dementsuste korral ja samuti mõnel sümptomiteta eakal.
For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Vizamyliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
What benefits of Vizamyl have been shown in studies?
Milles seisneb uuringute põhjal Vizamyli kasulikkus?
The Committee noted that PET scans with Vizamyl have a high sensitivity and specificity for detecting a significant amount of beta-amyloid plaques in the brain, and that scans closely reflect what was seen at autopsy.
Komitee märkis, et Vizamyliga tehtud PETuuringute tundlikkus ja spetsiifilisus olulise koguse beeta-amüloidnaastude tuvastamiseks ajus on väga suur ning uuringute ja lahangute tulemused on väga sarnased.
Vizamyl is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Vizamyli kasutatakse mäluprobleemidega täiskasvanud patsientide aju kihtülesvõtete tegemiseks, et arstid saaksid kontrollida beeta-amüloidnaastude olemasolu ajus.
How is Vizamyl used?
Kuidas Vizamyli kasutatakse?