natgillin/translations-raw huggingface dataset:
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?
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. 
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.
This is a summary of the European public assessment report (EPAR) for Vizamyl. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo 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). 
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).
The type of scan used with Vizamyl is called positron-emission tomography (PET). 
Vrsta preiskave, pri kateri se uporablja zdravilo Vizamyl, se imenuje pozitronska emisijska tomografija (PET).
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. 
Najpogostejši neželeni učinki zdravila Vizamyl (ki lahko prizadenejo med 1 in 10 bolnikov od 100) so zardevanje (rdečica na koži), in povišan krvni tlak.
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. 
Z varnostnega vidika zdravilo Vizamyl vključuje izpostavljenost bolnika majhni količini sevanja, ki je v razponu drugih odobrenih radiofarmakov, zato je varnostni profil sprejemljiv.
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. 
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.
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 pomeni, da so na podlagi preiskav PET kot pozitivne pravilno prepoznali med 81 in 93 % bolnikov, ki so imeli znatne količine leh v možganih.
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. 
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.
When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%. 
Ko so rezultate obdukcij primerjali s preiskavami PET, so ugotovili, da je bila občutljivost preiskav od 81- do 93-odstotna.
For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
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.
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. 
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.
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. 
Študija je proučevala občutljivost slikanja PET (kako dobro je slikanje izpostavilo bolnike z znatnimi količinami leh v možganih), kadar so ga tolmačile usposobljene osebe.
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. 
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.
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. 
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.
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. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vizamyl in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
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. 
Vendar je odbor izpostavil, da zaradi omejenih učinkov trenutno razpoložljivih oblik zdravljenja Alzheimerjeve bolezni po slikanju PET z zdravilom Vizamyl ni trdnih dokazov o takojšnjem izboljšanju obravnave bolnikov ali izidov pri bolnikih.
For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Vizamyl naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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. 
Vendar tudi pozitiven rezultat sam po sebi ne zadošča za postavitev diagnoze pri bolnikih, ki imajo težave s spominom, saj so lehe lahko prisotne pri bolnikih z različnimi vrstami demenc in pri nekaterih starejših bolnikih brez simptomov.
For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Vizamyl, glejte navodilo za uporabo.
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 ocenjuje kot pomemben napredek pri diagnosticiranju bolnikov, ki imajo težave s spominom in pri katerih se ugotavlja morebitna Alzheimerjeva bolezen ali druge oblike demence.
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. 
Zdravilo Vizamyl je radiofarmak (zdravilo z majhno količino radioaktivne snovi), ki vsebuje zdravilno učinkovino flutemetamol (18F); namenjeno je samo diagnostični uporabi.
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. 
Odbor je izpostavil, da ima slikanje PET z zdravilom Vizamyl veliko občutljivost in specifičnost pri zaznavanju znatnih količin beta-amiloidnih leh v možganih, preiskave pa skoraj popolnoma odražajo rezultate obdukcije.
Why is Vizamyl approved? 
Zakaj je bilo zdravilo Vizamyl odobreno?
How is Vizamyl used? 
Kako se zdravilo Vizamyl uporablja?
After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Vizamyl. 
Ko se pridobi posnetek, ga odčitajo zdravniki nuklearne medicine, ki so posebej usposobljeni za tolmačenje posnetkov PET z zdravilom Vizamyl.
Patients should discuss the results of their PET scan with their doctor. 
Bolniki se morajo o izidih preiskave PET pogovoriti z zdravnikom.
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. 
Zdravilo Vizamyl je na voljo v obliki raztopine, ki se daje z injiciranjem v veno približno 90 minut pred slikanjem s PET.
Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias. 
Izdaja zdravila Vizamyl je le na recept, preiskave PET z zdravilom Vizamyl pa lahko naročijo samo zdravniki, ki imajo izkušnje s klinično obravnavo bolnikov z boleznimi, kot so Alzheimerjeva bolezen in druge demence.
Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities. 
Zdravilo Vizamyl oddaja majhno količino sevanja, ki je povezano z zelo majhnim tveganjem za raka in prirojene nepravilnosti.
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. 
Zdravilo Vizamyl so proučevali v eni glavni študiji s 176 bolniki, ki so se približevali koncu življenja in so pristali na obdukcijo po njihovi smrti, v kateri so poskušali dokončno dokazati, ali so imeli ti bolniki znatne količine β-amiloidnih leh v možganih.
The radiation it emits can be detected on the PET scan, enabling doctors to see whether or not significant amount of plaques are present. 
Sevanje, ki ga oddaja, zazna aparat za PET in tako omogoči zdravnikom, da ugotovijo, ali je morda prisotna večja količina leh.
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. 
Ob zaključku študije so opravili obdukcijo pri 68 bolnikih, da bi potrdili, ali so imeli v možganih znatne količine β-amiloidnih leh.
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. 
Zdravilo Vizamyl se uporablja med možganskimi preiskavami pri bolnikih, ki imajo težave s spominom, da lahko zdravniki ugotovijo, ali imajo morda v možganih večje količine β-amiloidnih leh.
How does Vizamyl work? 
Kako zdravilo Vizamyl deluje?
Other information about Vizamyl 
Druge informacije o zdravilu Vizamyl
Vizamyl flutemetamol ( 
Vizamyl flutemetamol (18F)
The disease can lead to loss of vision. 
Bolezen lahko povzroči izgubo vida.
‘Vernal' means that it usually occurs in the spring. 
„Vernalni“ pomeni, da se običajno pojavi spomladi.
London, 20 November 2008 Doc. 
London, 20. novembra 2008 Sklic na dok.
International non-proprietary name (INN): ciclosporin 
Mednarodno nelastniško ime (INN): ciklosporin
Because ciclosporin has been used for many years, the applicant presented data on experimental models from the scientific literature. 
Ker se ciklosporin uporablja že mnogo let, je predlagatelj predstavil podatke o poskusnih modelih iz znanstvene literature.
The Committee also noted that the long-term effectiveness of the medicine had not been investigated. 
Odbor je prav tako poudaril, da dolgotrajna učinkovitost zdravila ni bila raziskana.
The main measure of effectiveness chosen was the change in the symptoms of the disease after four weeks, as scored by the doctor. 
Glavno merilo učinkovitosti je bila sprememba simptomov bolezni po štirih tednih, kot jih je ocenil zdravnik.
This means that it reduces the activity of the immune system (the body's natural defences). 
To pomeni, da učinkuje na aktivnost imunskega sistema (naravno obrambo telesa).
Ciclosporin has been used since the mid1980s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ). 
Ciklosporin se od sredine osemdesetih let prejšnjega stoletja uporablja za preprečevanje zavrnitve pri bolnikih po presaditvi (ko imunski sistem napade presajeni organ).