FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Slovenian: Pri tiazolidindionih, vključno s pioglitazonom, so v obdobju trženja poročali o novo nastalem diabetičnem makularnem edemu ali njegovem poslabšanju z zmanjšanjem ostrine vida.
English: Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Slovenian: Zaradi pomanjkanja podatkov uporaba zdravila Incresync pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: Treatment-corrected change from baseline in HbA1c (%)†
Slovenian: Z zdravilom korigirana sprememba vrednosti HbA1c od izhodišča (%)† (1-stranski IZ)
English: Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
Slovenian: Pred uvedbo zdravljenja z zdravilom Incresync in v rednih časovnih presledkih med zdravljenjem priporočamo izvedbo ustreznih preiskav za oceno delovanja ledvic (glejte poglavje 4.4).
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Slovenian: Pri moških, ki so prejemali pioglitazon, delež zlomov ni bil večji (1,7 %) kot pri moških, ki so prejemali primerjalno zdravilo (2,1 %).
English: Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin.
Slovenian: V obdobju trženja so bila spontana poročila o takšnih reakcijah pridobljena tudi za alogliptin.
English: - 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.
Slovenian: - Incresync 25 mg/45 mg filmsko obložene tablete (tablete) so okrogle (premer približno 8,7 mm), obojestransko izbočene, filmsko obložene tablete rdeče barve z odtisnjenima sivima oznakama “A/P” in “25/45” na eni strani.
English: Fasting and postprandial glycaemic control is improved following treatment with pioglitazone in patients with type 2 diabetes mellitus.
Slovenian: Zdravljenje s pioglitazonom pri bolnikih s sladkorno boleznijo tipa 2 izboljša urejenost glikemije na tešče in po obroku.
English: and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Slovenian: Celotna pojavnost epizod hude hipoglikemije je bila pri bolnikih, zdravljenih z alogliptinom v odmerku 25 mg (0,1 %) ali 12,5 mg (0,1 %) primerljiva in manjša od pojavnosti pri bolnikih, zdravljenih s kontrolnim zdravilom (0,4 %) ali placebom (0,4 %).
English: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting.
Slovenian: Pri uporabi zaviralcev DPP-4 so poročali o pojavu preobčutljivostnih reakcij, vključno z anafilaktičnimi reakcijami, angioedemom in eksfoliativnimi kožnimi boleznimi, vključno s Stevens-Johnsonovim sindromom in multiformnim eritemom.
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Slovenian: Pri podganah, ki so prejemale pioglitazon do 2 leti, so opažali večjo pojavnost hiperplazije (samci in samice) ter tumorjev (samci) epitelija sečnega mehurja.
English: Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Slovenian: Ena 25 mg/45 mg filmsko obložena tableta vsebuje alogliptinijev benzoat in pioglitazonijev klorid v količini, ki ustreza 25 mg alogliptina in 45 mg pioglitazona.
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone.
Slovenian: Poročali so, da se je pri sočasni uporabi pioglitazona in gemfibrozila (zaviralec citokroma P450 2C8) vrednosti AUC pioglitazona povečala za 3-krat.
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
Slovenian: IME ZDRAVILA Incresync 25 mg/45 mg tablete alogliptin/pioglitazon
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo zdravljenje z dializo, uporaba zdravila Incresync ni priporočljiva (glejte poglavje 4.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 25 mg alogliptina (v obliki benzoata) in 45 mg pioglitazona (v obliki klorida).
English: 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.
Slovenian: Ena 12,5 mg/45 mg filmsko obložena tableta vsebuje alogliptinijev benzoat in pioglitazonijev klorid v količini, ki ustreza 12,5 mg alogliptina in 45 mg pioglitazona.
English: Your blood sugar levels may increase when you stop taking Incresync.
Slovenian: Po prenehanju jemanja zdravila Incresync se vrednost krvnega sladkorja lahko zviša.
English: - 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.
Slovenian: - Incresync 12,5 mg/45 mg filmsko obložene tablete (tablete) so okrogle (premer približno 8,7 mm), obojestransko izbočene, filmsko obložene tablete svetlo rdeče barve z odtisnjenima rdečima oznakama “A/P” in “12.5/45” na eni strani.
English: - 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.
Slovenian: - Incresync 12,5 mg/30 mg filmsko obložene tablete (tablete) so okrogle (premer približno 8,7 mm), obojestransko izbočene, filmsko obložene tablete svetle breskove barve z odtisnjenima rdečima oznakama “A/P” in “12.5/30” na eni strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 30 mg pioglitazona (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
Slovenian: IME ZDRAVILA Incresync 25 mg/30 mg tablete alogliptin/pioglitazon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 45 mg pioglitazona (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
Slovenian: IME ZDRAVILA Incresync 12,5 mg/30 mg tablete alogliptin/pioglitazon
English: Incresync is not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
Slovenian: Pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, uporaba zdravila Incresync ni priporočljiva.
English: Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Slovenian: Ena 25 mg/30 mg filmsko obložena tableta vsebuje alogliptinijev benzoat in pioglitazonijev klorid v količini, ki ustreza 25 mg alogliptina in 30 mg pioglitazona.
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
Slovenian: IME ZDRAVILA Incresync 12,5 mg/45 mg tablete alogliptin/pioglitazon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 25 mg alogliptina (v obliki benzoata) in 30 mg pioglitazona (v obliki klorida).
English: Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Slovenian: Če se telesna masa poveča, o tem obvestite zdravnika.
English: No studies in lactating animals have been conducted with the combined active substances of Incresync.
Slovenian: Študije s kombinacijo zdravilnih učinkovin zdravila Incresync pri živalih med laktacijo niso bile izvedene.
English: Swallow your tablet(s) whole with water.
Slovenian: Zdravilo Incresync je treba vzeti enkrat na dan. Tableto (tablete) pogoltnite celo (cele) skupaj z vodo.
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Slovenian: Pri bolnikih s hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, uporaba zdravila Incresync ni priporočljiva.
English: Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Slovenian: Ena 12,5 mg/30 mg filmsko obložena tableta vsebuje alogliptinijev benzoat in pioglitazonijev klorid v količini, ki ustreza 12,5 mg alogliptina in 30 mg pioglitazona.
English: 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)
Slovenian: • rifampicin (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb).
English: Study
Slovenian: Zdravljenje
English: 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
Slovenian: EU/1/13/842/001 10 filmsko obloženih tablet EU/1/13/842/002 14 filmsko obloženih tablet EU/1/13/842/003 28 filmsko obloženih tablet EU/1/13/842/004 30 filmsko obloženih tablet EU/1/13/842/005 56 filmsko obloženih tablet EU/1/13/842/006 60 filmsko obloženih tablet EU/1/13/842/007 90 filmsko obloženih tablet EU/1/13/842/008 98 filmsko obloženih tablet EU/1/13/842/009 100 filmsko obloženih tablet
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Slovenian: Incresync 25 mg/45 mg filmsko obložene tablete alogliptin/pioglitazon
English: 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
Slovenian: EU/1/13/842/019 10 filmsko obloženih tablet EU/1/13/842/020 14 filmsko obloženih tablet EU/1/13/842/021 28 filmsko obloženih tablet EU/1/13/842/022 30 filmsko obloženih tablet EU/1/13/842/023 56 filmsko obloženih tablet EU/1/13/842/024 60 filmsko obloženih tablet EU/1/13/842/025 90 filmsko obloženih tablet EU/1/13/842/026 98 filmsko obloženih tablet EU/1/13/842/027 100 filmsko obloženih tablet
English: 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
Slovenian: EU/1/13/842/028 10 filmsko obloženih tablet EU/1/13/842/029 14 filmsko obloženih tablet EU/1/13/842/030 28 filmsko obloženih tablet EU/1/13/842/031 30 filmsko obloženih tablet EU/1/13/842/032 56 filmsko obloženih tablet EU/1/13/842/033 60 filmsko obloženih tablet EU/1/13/842/034 90 filmsko obloženih tablet EU/1/13/842/035 98 filmsko obloženih tablet EU/1/13/842/036 100 filmsko obloženih tablet
English: 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
Slovenian: EU/1/13/842/010 10 filmsko obloženih tablet EU/1/13/842/011 14 filmsko obloženih tablet EU/1/13/842/012 28 filmsko obloženih tablet EU/1/13/842/013 30 filmsko obloženih tablet EU/1/13/842/014 56 filmsko obloženih tablet EU/1/13/842/015 60 filmsko obloženih tablet EU/1/13/842/016 90 filmsko obloženih tablet EU/1/13/842/017 98 filmsko obloženih tablet EU/1/13/842/018 100 filmsko obloženih tablet
English: Iron oxide red (E172) Iron oxide red (E172) Iron oxide black (E172)
Slovenian: rdeči železov oksid (E172)
English: - 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.
Slovenian: - Pomožne snovi so: manitol, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, laktoza monohidrat, hipromeloza, smukec, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172), makrogol 8000, šelak, karnauba vosek in glicerilmonooleat.
English: - 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, carnauba wax and glycerol mono-oleate.
Slovenian: - Pomožne snovi so: manitol, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, laktoza monohidrat, hipromeloza, smukec, titanov dioksid (E171), rdeči železov oksid (E172), makrogol 8000, šelak, karnauba vosek in glicerilmonooleat.
English: Incresync 12.5 mg/30 mg film-coated tablets
Slovenian: Incresync 12,5 mg/30 mg filmsko obložene tablete alogliptin/pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
Slovenian: Incresync 25 mg/30 mg filmsko obložene tablete alogliptin/pioglitazon
English: - 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).
Slovenian: - Pomožne snovi so: manitol, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, laktoza monohidrat, hipromeloza, smukec, titanov dioksid (E171), rdeči železov oksid (E172), makrogol 8000, šelak in črni železov oksid (E172).
English: Incresync 12.5 mg/45 mg film-coated tablets
Slovenian: Incresync 12,5 mg/45 mg filmsko obložene tablete alogliptin/pioglitazon
English: The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat.
Slovenian: Domnevni mehanizem opaženega tumorogenega odziva pri samcih podgan je tvorba in prisotnost kamnov v sečilih s posledičnim draženjem in hiperplazijo.
English: What measures are being taken to ensure the safe and effective use of Vizamyl?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vizamyl?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vizamyl, veljavno po vsej Evropski uniji, izdala 22. avgusta 2014.
English: Doctors will therefore need to use the scan together with a clinical evaluation.
Slovenian: Zdravniki bodo zato morali uporabiti posnetke skupaj s klinično oceno.
English: 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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Vizamyl sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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.
Slovenian: Pri poznejši ponovni analizi so proučili podatke 68 izvirnih bolnikov skupaj z rezultati drugih bolnikov, ki so umrli po koncu izvirne študije, kar je pomenilo skupno 106 bolnikov.
English: It is not intended to provide practical advice on how to use Vizamyl.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What is Vizamyl and what is it used for?
Slovenian: Kaj je zdravilo Vizamyl in za kaj se uporablja?
English: A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vizamyl je bil pripravljen načrt obvladovanja tveganj.
English: What are the risks associated with Vizamyl?
Slovenian: Kakšna tveganja so povezana z zdravilom Vizamyl?
English: 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.
Slovenian: β-amiloidne lehe so obloge, ki so včasih prisotne v možganih oseb, ki imajo težave s spominom zaradi demence (kot so na primer Alzheimerjeva bolezen, demenca z Lewyjevimi telesci in demenca pri Parkinsonovi bolezni), ter tudi v možganih nekaterih starejših oseb, ki nimajo nobenih simptomov demence.
English: What benefits of Vizamyl have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vizamyl izkazalo v študijah?
English: 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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vizamyl večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Vizamyl.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vizamyl.
English: 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).
Slovenian: V tej ponovni analizi je bila večina strokovnjakov sposobna ralagati posnetke s približno 91-odstotno občutljivostjo (odkrili so 91 % bolnikov z lehami) in 90-odstotno specifičnostjo (pri 90 % bolnikih so pravilno ocenili odsotnost leh).
English: The type of scan used with Vizamyl is called positron-emission tomography (PET).
Slovenian: Vrsta preiskave, pri kateri se uporablja zdravilo Vizamyl, se imenuje pozitronska emisijska tomografija (PET).
English: 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.
Slovenian: Najpogostejši neželeni učinki zdravila Vizamyl (ki lahko prizadenejo med 1 in 10 bolnikov od 100) so zardevanje (rdečica na koži), in povišan krvni tlak.
English: 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.
Slovenian: Z varnostnega vidika zdravilo Vizamyl vključuje izpostavljenost bolnika majhni količini sevanja, ki je v razponu drugih odobrenih radiofarmakov, zato je varnostni profil sprejemljiv.
English: 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.
Slovenian: Poleg tega bo družba, ki trži zdravilo Vizamyl, omogočila dostop do izobraževalnega tečaja za vse zdravnike nuklearne medicine, za katere se pričakuje, da bodo uporabljali to zdravilo v Evropski uniji, s čimer bo zagotovila točno in zanesljivo tolmačenje posnetkov PET.
English: 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.
Slovenian: To pomeni, da so na podlagi preiskav PET kot pozitivne pravilno prepoznali med 81 in 93 % bolnikov, ki so imeli znatne količine leh v možganih.
English: 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.
Slovenian: Vendar je prisotno tveganje lažno pozitivnih rezultatov (kadar bolnike brez leh ocenijo kot pozitivne), zato se same preiskave z zdravilom Vizamyl ne smejo uporabljati za diagnosticiranje demence, temveč jih je treba obravnavati skupaj s klinično oceno bolnika.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%.
Slovenian: Ko so rezultate obdukcij primerjali s preiskavami PET, so ugotovili, da je bila občutljivost preiskav od 81- do 93-odstotna.
English: For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vizamyl preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: 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.
Slovenian: Poleg tega uporabnost zdravila Vizamyl pri napovedovanju razvoja Alzheimerjeve bolezni pri bolnikih, ki imajo težave s spominom, ali pri spremljanju odziva bolnikov na zdravljenje ni bila ugotovljena.
English: 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.
Slovenian: Študija je proučevala občutljivost slikanja PET (kako dobro je slikanje izpostavilo bolnike z znatnimi količinami leh v možganih), kadar so ga tolmačile usposobljene osebe.
English: 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.
Slovenian: Če je na posnetku PET β-amiloidnih leh malo ali če jih sploh ni (negativen rezultat preiskave), je malo verjetno, da ima bolnik Alzheimerjevo bolezen.
English: 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.
Slovenian: Zdravilna učinkovina v zdravilu Vizamyl, flutemetamol (18F), je radiofarmak, ki oddaja majhne količine sevanja in deluje tako, da se usmeri in veže na β-amiloidne lehe v možganih.