natgillin/translations-raw huggingface dataset:
Metformin (immediate- or extended-release formulations) ≥ 1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment. 
Metformin (v obliki s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki je moral biti vsaj polovica največjega odmerka) sulfonilsečnine, vsaj 8 tednov pred vključitvijo aRandomizirani in zdravljeni bolniki z izhodiščno in vsaj še 1 poizhodiščno meritvijo učinkovitosti bHbA1c analiziran z LRM (analiza longitudinalnih ponavljajočih se meritev)
Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4). 
O učinkih, povezanih s pomanjkanjem volumna (vključno z dehidracijo, hipovolemijo ali hipotenzijo) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
Nervous system disorders 
Bolezni živčevja motnje okušanja§
In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation. 
dne gestacije do 21. postnatalnega dneva; mladiči so bili posredno izpostavljeni in utero in med obdobjem dojenja.
Signs include feeling or being very sick, vomiting, stomach ache, muscular cramps, severe tiredness, or difficulty breathing. 
Znaki te motnje vključujejo občutek slabosti ali hudo slabost, bruhanje, bolečine v trebuhu, mišične krče, hudo utrujenost ali težko dihanje.
Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo. 
gPovprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM AstraZeneca AB
No dose adjustment is recommended for patients with mild renal impairment. 
Bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; - by delaying intestinal glucose absorption. 
Metformin lahko deluje po treh mehanizmih: - z zmanjšanjem nastajanja glukoze v jetrih z zavrtjem glukoneogeneze in glikogenolize,
In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anti-coagulatory effects of warfarin as measured by INR. 
sitagliptina, glimepirida, hidroklorotiazida, bumetanida, valsartana, digoksina (ki je substrat P-gp) ali varfarina (S-varfarina, ki je substrat CYP2C9); prav tako ni spremenil antikoagulantnih učinkov varfarina,
Tell your doctor before you start taking this medicineif you have any of these signs. 
Če imate katerega od teh znakov, morate to povedati zdravniku, preden začnete jemati to zdravilo.
Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks. 
Linearnost Izpostavljenost dapagliflozinu se je v razponu odmerkov od 0,1 do 500 mg povečevala sorazmerno povečanju odmerka.
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01). 
- značilno zmanjšanje absolutnega tveganja vseh zapletov sladkorne bolezni v skupini z metforminom (29,8 dogodka/1000 bolnik-let) v primerjavi z dieto samo (43,3 dogodka/1000 bolnik-let), p = 0,0023, ter v primerjavi z združenimi podatki skupin monoterapije s sulfonilsečnino in z insulinom (40,1 dogodka/1000 bolnik-let), p = 0,0034;
These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection. 
1,2 % s placebom), osebe z anamnezo pa so imele večjo verjetnost za ponavljajoče se okužbe.
Urticaria§ Erythema Pruritus§ 
Okvara ledvic
Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks. 
Med 12-tedensko uporabo 10 mg dapagliflozina na dan se je pri bolnikih s sladkorno boleznijo tipa 2 z urinom izločilo približno 70 g glukoze na dan (to ustreza 280
Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years. 
Pri bolnikih s sladkorno boleznijo tipa 2, ki so dobivali 10 mg dapagliflozina na dan do 2 leti,
Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis. 
okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis.
Results of (LOCFa) placebo-controlled studies up to 24 weeks of dapagliflozin in add-on combination with metformin or metformin plus sitagliptin 
Rezultati s placebom kontrolirane študije dapagliflozina kot dodatek metforminu samemu ali metforminu v kombinaciji s sitagliptinom po 24 tednih (LOCFa)
In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7% of subjects treated with dapagliflozin and 3.8% of subjects treated with placebo (see section 4.4). 
zabeležili pri 7,7 % tistih, ki so prejemali dapagliflozin, in pri 3,8 % tistih, ki so prejemali placebo (glejte poglavje 4.4).
Musculoskeletal and connective tissue disorders 
Bolezni mišično skeletnega sistema in vezivnega tkiva bolečine v hrbtu*
The following statements reflect the preclinical safety data of the individual active substances of Xigduo. 
Naslednje navedbe temeljijo na predkliničnih podatkih o varnosti za posamezni učinkovini zdravila
Dapagliflozin as an add-on to metformin alone or metformin plus sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant body weight reduction up to 24 weeks (p < 0.0001, Tables 3, 4 and 5). 
sulfonilsečnino ali insulinom (z dodatnimi peroralnimi zdravili za znižanje glukoze (vključno z metforminom) ali brez njih) je do 24. tedna statistično značilno znižal telesno maso (p < 0,0001, preglednice 3, 4 in 5).
Reported in ≥ 2% of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo. 
≥ 0,2 % preiskovancev ter pri ≥ 0,1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
≥ 15 mg/kg/day (associated with pup exposures that are ≥ 29 times the human values at the maximum recommended human dose). 
Dodatni toksični učinki na razvoj so bili omejeni na od odmerka odvisna zmanjšanja telesne mase mladičev, zabeležili pa so jih le pri odmerkih ≥ 15 mg/kg/dan (to je povezano z izpostavljenostjo mladičev, ki je ≥ 29-krat večja od izpostavljenosti človeka pri največjem priporočenem odmerku za človeka).
EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack) 
EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablet (skupno pakiranje)
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. 
To je bilo v terapevtskih odmerkih dokazano v kontroliranih srednjeročnih in dolgoročnih kliničnih študijah:
HbA1c analyzed using LRM (Longitudinal repeated measures analysis) Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s) 
Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika
Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products. 
Med slednjimi jih je 80 % jemalo samo metformin, 12 % jih je jemalo metformin in sulfonilsečnino, preostali pa so uporabljali druge peroralne antidiabetike.
Hypoglycaemia (when used with SU or insulin)b 
Presnovne in prehranske motnje hipoglikemija (med uporabo s sulfonilsečninami ali insulinom)b pomanjkanje volumnab,e žeja**
Dapagliflozin as an add-on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant mean reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 3, 4 and 5). 
sulfonilsečnino ali insulinom (z dodatnimi peroralnimi antidiabetiki (vključno z metforminom) ali brez njih) je po 24 tednih statistično značilno znižal HbA1c v primerjavi s prejemniki placeba (p < 0.0001, preglednice 3, 4 in 5).
Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%. 
jPovprečni odstotek spremembe od izhodišča za 10 mg dapagliflozina v primerjavi s placebom je bil: celokupni holesterol 2,5 % v prim.
EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets 
EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablet
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride 
Xigduo 5 mg/850 mg filmsko obložene tablete dapagliflozin/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl 
Xigduo 5 mg/850 mg tablete dapagliflozin/metforminijev klorid
Lactic acidosis 
Sulfonilsečnina
2Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study cAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period dLeast squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + oral glucose-lowering medicinal product ***The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001). 
*Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik Vrednost p < 0,05 v primerjavi s kombinacijo placebo + peroralni antidiabetik ***Odstotek spremembe telesne mase so analizirali kot sekundarni opazovani dogodek (p < 0,0001); absolutno spremembo telesne mase (v kg) so analizirali z nominalno vrednostjo p (p < 0,0001).
EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose) 
EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tableta (enkratni odmerek)
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride 
Xigduo 5 mg/1000 mg filmsko obložene tablete dapagliflozin/metforminijev klorid
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in
In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, respectively, compared with healthy matched control subjects. 
Okvara jeter Pri preiskovancih z blago ali zmerno okvaro jeter (Child-Pugh A in B) je bila Cmax dapagliflozina do 12 %
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets 
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablet
• redness of the skin (erythema),itching or an itchy rash (hives) 
• pordelost kože (rdečica), srbenje ali srbeč izpuščaj (koprivnica) Poročanje o neželenih učinkih
Treatment with dapagliflozin as an add-on to either metformin alone (dapagliflozin 10 mg QD or dapagliflozin 5 mg BID) or metformin plus sitagliptin, sulphonylurea or insulin resulted in statistically significant reductions in fasting plasma glucose (-1.90 to -1.20 mmol/l [-34.2 to -21.7 mg/dl]) compared with placebo (-0.58 to 0.18 mmol/l [-10.4 to 3.3 mg/dl]) at Week 16 (5 mg BID) or Week 24. 
1,20 mmol/l [-34,2 do -21,7 mg/dl]) v primerjavi s placebom (-0,58 do 0,18 mmol/l [-10,4 do 3,3 mg/dl])
• Lactic acidosis. 
mg metforminijevega klorida.
EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets 
EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablet
EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets 
EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablet
Blood creatinine increased**,b 
Preiskave zvišan hematokritg zmanjšan ledvični očistek kreatininab zvišanje kreatinina v krvi**,b zvišanje sečnine v
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl 
Xigduo 5 mg/1000 mg tablete dapagliflozin/metforminijev klorid
Very common (may affect more than 1 in 10 people) 
Drugi neželeni učinki vključujejo: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM AstraZeneca AB
These are the signs of low blood sugar: - shaking, sweating, feeling very anxious, fast heart beat - feeling hungry, headache, change in vision - a change in your mood or feeling confused. 
- lakota, glavobol, spremembe vida - sprememba razpoloženja ali zmedenost
EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets 
EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablet
Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin 
Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom metforminu po 52 tednih (LOCFa) Parameter
EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablets 
EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablet
Vulvovaginal pruritus** 
Motnje reprodukcije in dojk vulvovaginaln o srbenje**
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets 
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablet
• changes in taste 
• spremembe okusa • omotica
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets 
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablet
MARKETING AUTHORISATION HOLDER AstraZeneca AB 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM AstraZeneca AB
For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively). 
10 mg dapagliflozina -0,78 % in s placebom 0,02 %).
Add-on combination Sulphonylurea + Metformin1 
Razlika v primerjavi s kombinacijo glipizid + metforminc
EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack) 
EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
Package leaflet: Information for the patient Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride 
Navodilo za uporabo Xigduo 5 mg/850 mg filmsko obložene tablete Xigduo 5 mg/1000 mg filmsko obložene tablete dapagliflozin/metforminijev klorid Za to zdravilo se izvaja dodatno spremljanje varnosti.
At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide, respectively. 
HbA1c od izhodišča z dapagliflozinom -0,10 % in z glipizidom 0,20 %.
Dysuria Polyuria*,f 
Bolezni sečil dizurija* poliurija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje dapagliflozin-propandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 850
(95% CI) LOCF: Last observation carried forward bRandomised and treated subjects with baseline and at least 1 post-baseline efficacy measurement Least squares mean adjusted for baseline value dNon-inferior to glipizide + metformin p-value < 0.0001 
Randomizirani in zdravljeni preiskovanci z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti cPovprečje najmanjših kvadratov, korigirano za izhodiščno vrednost
Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, 
Metformin ≥ 1500 mg/dan,
LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product 
(95 % IZ) 1Metformin ≥ 1500 mg/dan, 2Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija cVsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost
During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50%) and placebo/comparator (1.50%), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3). 
ki so prejemali dapagliflozin (1,50 %), in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %), podoben.
Malignancies 
omotica
Signs of ‘lactic acidosis' are: - feeling or being very sick - vomiting, stomach ache - muscular cramps - severe tiredness - difficulty breathing. 
- občutek slabosti ali huda slabost - bruhanje, bolečine v trebuhu - mišični krči
Invented name/ Name 
Izmišljeno ime Ime
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA
Content (concentratio n) 
Vsebina (koncentracija)
Strength Pharmaceutic al form 
Farmacevtska oblika
It is available as tablets (1 mg). 
Na voljo je v obliki tablet (1 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005. 
Evropska komisija je dovoljenje za promet z zdravilom Azilect, veljavno po vsej Evropski uniji, izdala 21. februarja 2005.
The studies lasted 26 and 18 weeks, respectively. 
Študije so trajale 26 oziroma 18 tednov.
Other information about Azilect 
Druge informacije o zdravilu Azilect
The standard dose of Azilect is one tablet once a day. 
Priporočeni odmerek zdravila Azilect je ena tableta enkrat na dan.
The full EPAR for Azilect 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) za zdravilo Azilect je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Azilect shown during the studies? 
Kakšne koristi je zdravilo Azilect izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Azilect. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azilect.
The most common side effect with Azilect (seen in more than 1 patient in 10) is headache. 
Najpogostejši neželeni učinek zdravila Azilect (opažen pri več kot 1 bolniku od 10) je glavobol.
Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease. 
Zdravilo Azilect so raziskovali v treh glavnih študijah, ki so vključevale skupaj 1 563 bolnikov s Parkinsonovo boleznijo.
For more information about treatment with Azilect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Azilect preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Azilect večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS). 
Glavno merilo učinkovitosti je bila sprememba simptomov po 26 tednih, ki je bila ocenjena s standardno lestvico (Enotno ocenjevalno lestvico Parkinsonove bolezni - Unified Parkinson's Disease Rating Scale, UPDRS).
Azilect is a medicine that contains the active substance rasagiline. 
Azilect je zdravilo, ki vsebuje zdravilno učinkovino razagilin.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azilect. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The main measure of effectiveness was the time spent in the ‘off' state during the day, as recorded in patients' diaries. 
Glavno merilo učinkovitosti je bil čas preživet v stanju „off“ v teku dneva, kot je bilo zabeleženo v bolnikovem dnevniku.
It was compared with placebo or entacapone (another medicine for Parkinson's disease). 
Primerjali so ga s placebom ali entakaponom (drugim zdravilom za zdravljenje Parkinsonove bolezni).
The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa. 
V drugi dve študiji je bilo vključenih skupno 1 159 bolnikov z boleznijo v kasnejši fazi, pri katerih je bilo zdravilo Azilect dodano k bolnikovemu obstoječemu zdravljenju, ki je vključevalo levodopo.