natgillin/translations-raw huggingface dataset:
Common: - Symptoms of low blood sugar (hypoglycaemia) may occur when Incresync is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Incresync jemljete skupaj z insulinom ali s sulfonilsečninami (npr. glipizid, tolbutamid,
Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Imetnik dovoljenja za promet z zdravilom Takeda Pharma A/S
INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
PODATKI V BRAILLOVI PISAVI Incresync 12,5 mg/45 mg
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Večji delež zlomov so opazili pri ženskah, ki so prejemale pioglitazon (2,6 %), kot pri ženskah, ki so prejemale primerjalno zdravilo (1,7 %).
INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
PODATKI V BRAILLOVI PISAVI Incresync 12,5 mg/30 mg
Warnings and precautions Talk to your doctor or pharmacist before taking Incresync: - if you have type 1 diabetes (your body does not produce insulin).
• če imate sladkorno bolezen tipa 1 (telo ne proizvaja insulina).
Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common
Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti pogosti pogosti nazofaringitis pogosti sinuzitis občasni pogosti
Foetal growth restriction was apparent in animal studies with pioglitazone.
V študijah pioglitazona na živalih so opazili omejitev rasti plodov.
Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
• Trenutni rak sečnega mehurja ali rak sečnega mehurja v anamnezi (glejte poglavje 4.4).
INFORMATION IN BRAILLE Incresync 25 mg/30 mg
PODATKI V BRAILLOVI PISAVI Incresync 25 mg/30 mg
Metabolism and nutrition disorders hypoglycaemia common common
Presnovne in prehranske motnje hipoglikemija pogosti pogosti
Incresync may, therefore, be administered with or without food.
Zdravilo Incresync se tako lahko jemlje s hrano ali brez nje.
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9).
Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u > 9) uporabe alogliptina niso raziskovali.
Placebo-corrected change from baseline in HbA1c (%)†
S placebom korigirana sprememba vrednosti HbA1c od izhodišča (%)† (2-stranski 95 % IZ)
You may experience visual disturbances while taking this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem tega zdravila se lahko pojavijo motnje vida.
- Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
• Težave z jetri, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu, neobičajna ali nepojasnjena utrujenost, izguba apetita, temen urin ali rumeno obarvanje kože ali očesnih beločnic.
Incresync contains lactose
Zdravilo Incresync vsebuje laktozo
- if you have heart failure or have had heart failure in the past.
• če imate ali ste kdaj imeli srčno popuščanje.
Alogliptin as add-on therapy to pioglitazone with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Alogliptin kot dodatek k zdravljenju s pioglitazonom in z metforminom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s 30 mg pioglitazona in z metforminijevim kloridom (povprečni odmerek = 1.867,9 mg) je v 52. tednu povzročil izboljšanja glede na izhodiščne vrednosti HbA1c.
How to store Incresync
Shranjevanje zdravila Incresync
Incresync 25 mg/45 mg film-coated tablets
Incresync 25 mg/45 mg filmsko obložene tablete
There is no experience of using Incresync in pregnant women or during breast-feeding.
Pri nosečnicah ali doječih materah ni izkušenj z uporabo zdravila Incresync.
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 sečnega mehurja, vključno s krvjo v urinu, bolečino med uriniranjem ali nenadno potrebo po uriniranju.
25 mg/30 mg film-coated tablets
25 mg/30 mg filmsko obložene tablete
After administration of single, oral doses of up to 800 mg in healthy subjects, alogliptin was rapidly absorbed with peak plasma concentrations occurring 1 to 2 hours (median Tmax) after dosing.
Največje koncentracije v plazmi so bile dosežene 1 do 2 uri (mediana vrednost Tmax) po odmerku.
12.5 mg/45 mg film-coated tablets
12,5 mg/45 mg filmsko obložene tablete
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.
Okrogle (premer približno 8,7 mm), bikonveksne, filmsko obložene tablete rdeče barve z odtisnjenima sivima oznakama “A/P” in “25/45” na eni strani.
However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
Odmerka glede na starost ni treba prilagajati (glejte poglavje 4.4), vendar pa je pri bolnikih z višjo starostjo treba alogliptin odmerjati previdno, saj pri tej populaciji bolnikov obstaja tveganje za oslabljeno delovanje ledvic.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Pri bolnikih, mlajših od 75 let, s sladkorno boleznijo tipa 2 in že obstoječo hujšo makrovaskularno boleznijo, so izvedli študijo kardiovaskularnega izida zdravljenja s pioglitazonom.
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.
Izgled zdravila Incresync in vsebina pakiranja - Incresync 25 mg/30 mg filmsko obložene tablete (tablete) so okrogle (premer približno 8,7 mm), obojestransko izbočene, filmsko obložene tablete breskove barve z odtisnjenima sivima oznakama “A/P” in “25/30” na eni strani.
Printing ink 12.5 mg/30 mg film-coated tablets
Črnilo za tisk 12,5 mg/30 mg filmsko obložene tablete
12.5 mg/30 mg film-coated tablets
12,5 mg/30 mg filmsko obložene tablete
Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Pri odmerkih od 2 do 60 mg so opazili sorazmerna povečanja koncentracije v serumu.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Pri tiazolidindionih, vključno s pioglitazonom, so v obdobju trženja poročali o novo nastalem diabetičnem makularnem edemu ali njegovem poslabšanju z zmanjšanjem ostrine vida.
Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Zaradi pomanjkanja podatkov uporaba zdravila Incresync pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
Treatment-corrected change from baseline in HbA1c (%)†
Z zdravilom korigirana sprememba vrednosti HbA1c od izhodišča (%)† (1-stranski IZ)
Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
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).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Pri moških, ki so prejemali pioglitazon, delež zlomov ni bil večji (1,7 %) kot pri moških, ki so prejemali primerjalno zdravilo (2,1 %).
Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin.
V obdobju trženja so bila spontana poročila o takšnih reakcijah pridobljena tudi za alogliptin.
- 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 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.
Fasting and postprandial glycaemic control is improved following treatment with pioglitazone in patients with type 2 diabetes mellitus.
Zdravljenje s pioglitazonom pri bolnikih s sladkorno boleznijo tipa 2 izboljša urejenost glikemije na tešče in po obroku.
and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
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 %).
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.
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.
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.
Pri podganah, ki so prejemale pioglitazon do 2 leti, so opažali večjo pojavnost hiperplazije (samci in samice) ter tumorjev (samci) epitelija sečnega mehurja.
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
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.
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.
Poročali so, da se je pri sočasni uporabi pioglitazona in gemfibrozila (zaviralec citokroma P450 2C8) vrednosti AUC pioglitazona povečala za 3-krat.
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
IME ZDRAVILA Incresync 25 mg/45 mg tablete alogliptin/pioglitazon
Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis (see section 4.2).
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).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 25 mg alogliptina (v obliki benzoata) in 45 mg pioglitazona (v obliki klorida).
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.
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.
Your blood sugar levels may increase when you stop taking Incresync.
Po prenehanju jemanja zdravila Incresync se vrednost krvnega sladkorja lahko zviša.
- 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 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.
- 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 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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 30 mg pioglitazona (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
IME ZDRAVILA Incresync 25 mg/30 mg tablete alogliptin/pioglitazon
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 45 mg pioglitazona (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
IME ZDRAVILA Incresync 12,5 mg/30 mg tablete alogliptin/pioglitazon
Incresync is not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
Pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, uporaba zdravila Incresync ni priporočljiva.
Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
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.
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
IME ZDRAVILA Incresync 12,5 mg/45 mg tablete alogliptin/pioglitazon
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 25 mg alogliptina (v obliki benzoata) in 30 mg pioglitazona (v obliki klorida).
Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Če se telesna masa poveča, o tem obvestite zdravnika.
No studies in lactating animals have been conducted with the combined active substances of Incresync.
Študije s kombinacijo zdravilnih učinkovin zdravila Incresync pri živalih med laktacijo niso bile izvedene.
Swallow your tablet(s) whole with water.
Zdravilo Incresync je treba vzeti enkrat na dan. Tableto (tablete) pogoltnite celo (cele) skupaj z vodo.
Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Pri bolnikih s hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, uporaba zdravila Incresync ni priporočljiva.
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
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.
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 (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb).
Study
Zdravljenje
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 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
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Incresync 25 mg/45 mg filmsko obložene tablete alogliptin/pioglitazon
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 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
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 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
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 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
Iron oxide red (E172) Iron oxide red (E172) Iron oxide black (E172)
rdeči železov oksid (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.
- 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.
- 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.
- 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.
Incresync 12.5 mg/30 mg film-coated tablets
Incresync 12,5 mg/30 mg filmsko obložene tablete alogliptin/pioglitazon
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
Incresync 25 mg/30 mg filmsko obložene tablete alogliptin/pioglitazon
- 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).
- 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).
Incresync 12.5 mg/45 mg film-coated tablets
Incresync 12,5 mg/45 mg filmsko obložene tablete alogliptin/pioglitazon
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.
Domnevni mehanizem opaženega tumorogenega odziva pri samcih podgan je tvorba in prisotnost kamnov v sečilih s posledičnim draženjem in hiperplazijo.
What measures are being taken to ensure the safe and effective use of Vizamyl?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vizamyl?
The European Commission granted a marketing authorisation valid throughout the European Union for Vizamyl on 22 August 2014.
Evropska komisija je dovoljenje za promet z zdravilom Vizamyl, veljavno po vsej Evropski uniji, izdala 22. avgusta 2014.
Doctors will therefore need to use the scan together with a clinical evaluation.
Zdravniki bodo zato morali uporabiti posnetke skupaj s klinično oceno.
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.
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.
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.
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.
It is not intended to provide practical advice on how to use Vizamyl.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Vizamyl and what is it used for?
Kaj je zdravilo Vizamyl in za kaj se uporablja?
A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Vizamyl je bil pripravljen načrt obvladovanja tveganj.
What are the risks associated with Vizamyl?
Kakšna tveganja so povezana z zdravilom Vizamyl?
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.
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.
What benefits of Vizamyl have been shown in studies?
Kakšne koristi je zdravilo Vizamyl izkazalo v študijah?