FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: U prospektivnom randomiziranom ispitivanju (UKPDS) utvrđeni su dugoročni povoljni učinci intenzivne regulacije glikemije u bolesnika sa šećernom bolešću tipa 2. Analiza rezultata u bolesnika s prekomjernom tjelesnom težinom liječenih metforminom nakon neuspjele regulacije glikemije samo dijetom pokazala je sljedeće: - značajno smanjenje apsolutnog rizika od bilo koje komplikacije povezane sa šećernom bolešću u skupini liječenoj metforminom (29,8 događaja na 1000 bolesnik-godina) u odnosu na skupinu bolesnika u kojih je glikemija bila regulirana samo dijetom (43,3 događaja na 1000 bolesnik-godina), p=0,0023, i u odnosu na objedinjene podatke iz skupina koje su uzimale samo sulfonilureju ili primale samo inzulin (40,1 događaja na 1000 bolesnik-godina), p=0,0034; - značajno smanjenje apsolutnog rizika od bilo koje smrtnosti povezane sa šećernom bolešću:
English: • Lactic acidosis.
Croatian: • Laktacidoza.
English: The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Croatian: Primjena kontrastnih sredstava koja sadrže jod Intravaskularna primjena kontrastnih sredstava koja sadrže jod u radiološkim ispitivanjima može uzrokovati zatajenje bubrega.
English: In a juvenile toxicity study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Croatian: 90. dana nakon okota, kod svih je doza prijavljeno proširenje bubrežne nakapnice i tubula; izloženost mladunčadi pri najnižoj ispitivanoj dozi bila je ≥ 15 puta veća od izloženosti kod maksimalne preporučene doze u ljudi.
English: Small increases in serum PTH levels were observed with increases being larger in subjects with higher baseline PTH concentrations.
Croatian: Paratiroidni hormon (PTH) Primijećena su blaga povišenja razine PTH-a u serumu, koja su bila izraženija u bolesnika s višim koncentracijama PTH-a na početku liječenja.
English: How to store Xigduo
Croatian: Moguće nuspojave Kako čuvati Xigduo
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET AstraZeneca AB
English: 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.
Croatian: koji su tijekom 12 tjedana primali dozu dapagliflozina od 10 mg na dan u mokraću je izlučeno približno 70 g glukoze na dan (što odgovara 280 kcal na dan).
English: In two 12-week, placebo-controlled studies a total of 1,062 patients with inadequately controlled type 2 diabetes and hypertension (despite pre-existing stable treatment with an ACE-I or ARB in one study and an ACE-I or ARB plus one additional antihypertensive treatment in another study) were treated with dapagliflozin 10 mg or placebo.
Croatian: U dva 12-tjedna, placebom kontrolirana ispitivanja ukupno su 1062 bolesnika s nedovoljno dobro reguliranom šećernom bolešću tipa 2 i hipertenzijom (unatoč postojećoj stabilnoj terapiji ACE
English: 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)
Croatian: Srednja vrijednost dobivena metodom najmanjih kvadrata prilagođena za početnu vrijednost p-vrijednost < 0,0001 u odnosu na placebo + peroralni lijek/ovi za snižavanje razine glukoze
English: Dapagliflozin 5 mg twice daily provided statistically significant reductions in HbA1c at 16 weeks compared with subjects receiving placebo (p < 0.0001; Table 3).
Croatian: HbA1c u 16. tjednu u usporedbi s ispitanicima koji su primali placebo (p < 0,0001; Tablica 3)
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline Body weight (kg) Baseline (mean) Change from Baselinec Difference from Placeboc (95% CI)
Croatian: Početna vrijednost (srednja) Promjena od početne vrijednostic Razlika u odnosu na placeboc (95% CI) Ispitanici (%) koji postižu: HbA1c<7%
English: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Croatian: Dapagliflozin se u velikoj mjeri metabolizira, pri čemu se prvenstveno stvara dapagliflozin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 5 mg dapagliflozina u obliku dapagliflozin propandiolhidrata i 850 mg metforminklorida.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava poremećaj osjeta okusa§ omaglica
English: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets
Croatian: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tableta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 5 mg dapagliflozina u obliku dapagliflozin propandiolhidrata i 1000 mg metforminklorida.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki vulvovaginalni pruritus**
English: HbA1c (%) Baseline (mean) Change from baselinec Difference from glipizide + metforminc (95% CI)
Croatian: Razlika u odnosu na glipizid + metforminc (95% CI)
English: Haematocrit increasedg
Croatian: Tablični prikaz nuspojava
English: EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose)
Croatian: EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tableta (jedinična doza)
English: Reported in ≥ 2% of subjects and ≥ 1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Croatian: *Prijavljeno u ≥ 2% ispitanika liječenih dapagliflozinom u dozi od 10 mg i ≥ 1% te u najmanje 3 ispitanika više nego kod primjene placeba.
English: Results of (LOCFa) placebo-controlled studies up to 24 weeks of dapagliflozin in add-on combination with metformin or metformin plus sitagliptin
Croatian: Tablica 3. Rezultati placebom kontroliranih ispitivanja dapagliflozina kao dodatka u kombiniranom liječenju metforminom ili metforminom i sitagliptinom u trajanju od 24 tjedna (LOCFa) Dodatak kombiniranom liječenju
English: Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease renal function.
Croatian: Budući da mogu umanjiti bubrežnu funkciju, primjena diuretika, osobito diuretika Henleyeve petlje, može povećati rizik od laktacidoze.
English: ≥ 15 mg/kg/day (associated with pup exposures that are ≥ 29 times the human values at the maximum recommended human dose).
Croatian: Dodatna razvojna toksičnost bila je ograničena na smanjenje tjelesne težine mladunčadi povezano s dozom, a primijećena je samo kod doza ≥ 15 mg/kg na dan (što je povezano s izloženošću u mladunčadi ≥ 29 većom od izloženosti u ljudi kod primjene maksimalne preporučene doze).
English: aRandomized and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Croatian: Randomizirani i liječeni bolesnici kod kojih je mjerena djelotvornost pri početnoj vrijednosti i barem jednom nakon početne vrijednosti
English: Hypoglycaemia
Croatian: • omaglica
English: EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets
Croatian: EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tableta
English: EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets
Croatian: EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tableta
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared with the group treated with glipizide (40.8%, 47% and 50.0%, respectively).
Croatian: 104 tjedna i 5,0% tijekom 208 tjedana) nego u skupini koja je primala glipizid (40,8% tijekom 52 tjedna, 47% tijekom 104 tjedna i 50,0% tijekom 208 tjedana).
English: Tell your doctor before you start taking this medicineif you have any of these signs.
Croatian: Mogući znakovi dehidracije navedeni su na početku dijela 4. Obavijestite svog liječnika prije uzimanja ovog lijeka ako imate neki od navedenih znakova
English: Dysuria Polyuria*,f
Croatian: Poremećaji bubrega i mokraćnog sustava dizurija poliurija*,f nokturija**
English: Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A
Croatian: magnezijev stearat (E470b) natrijev škroboglikolat, tip A
English: 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
Croatian: Ispitanici sa smanjenjem srednje dnevne doze inzulina od najmanje 10% (%) aLOCF (Last observation carried forward): Prijenos posljednjih zabilježenih vrijednosti (prije ili na dan prvog povećanja doze inzulina, ako je potrebno) bSvi randomizirani bolesnici koji su tijekom kratkoročnog dvostruko slijepog razdoblja uzeli barem jednu dozu ispitivanog lijeka u dvostruko slijepom ispitivanju cSrednja vrijednost dobivena metodom najmanjih kvadrata prilagođena za početnu vrijednost i prisutnost peroralnih lijekova za snižavanje razine glukoze *p-vrijednost < 0,0001 u odnosu na placebo + inzulin ± peroralni lijek za snižavanje razine glukoze p-vrijednost < 0,05 u odnosu na placebo + inzulin ± peroralni lijek za snižavanje razine glukoze
English: Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and postmarketing dataa
Croatian: Nuspojave iz kliničkog ispitivanja dapagliflozina i metformina s trenutnim otpuštanjem te iz podataka prikupljenih nakon stavljanja lijeka u prometa Organski sustav
English: Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Croatian: Tablica 4. Rezultati placebom kontroliranog ispitivanja dapagliflozina kao dodatka u kombiniranom liječenju metforminom i sulfonilurejom u trajanju 24 tjedna Dodatak kombiniranom liječenju sulfonilureja + metformin1
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
Croatian: Xigduo 5 mg/850 mg tablete dapagliflozin/metforminklorid
English: Urine glucose
Croatian: To je izlučivanje glukoze
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Croatian: Xigduo 5 mg/850 mg filmom obložene tablete dapagliflozin/metforminklorid
English: Use in patients with renal impairment
Croatian: Primjena u bolesnika s oštećenjem bubrežne funkcije
English: Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin
Croatian: Rezultati ispitivanja kontroliranog aktivnim lijekom u kojem su se uspoređivali dapagliflozin i glipizid kao dodaci metforminu nakon 52 tjedna (LOCFa) Parametar
English: MARKETING AUTHORISATION HOLDER AstraZeneca AB
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET AstraZeneca AB
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Croatian: Xigduo 5 mg/1000 mg filmom obložene tablete dapagliflozin/metforminklorid
English: 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).
Croatian: (95% CI) Kratice: QD: jedanput na dan; BID: dvaput na dan 1Metformin ≥ 1500 mg na dan; 2sitagliptin 100 mg na dan LOCF: Prijenos zadnjih zabilježenih vrijednosti (prije primjene terapije za hitnu regulaciju glikemije u ispitanika kojima je primijenjena takva terapija) (Last observation carried forward) Placebom kontrolirano 16-tjedno ispitivanje cSvi randomizirani ispitanici koji su tijekom kratkoročnog dvostruko slijepog razdoblja uzeli barem jednu dozu ispitivanog lijeka u dvostruko slijepom ispitivanju dSrednja vrijednost dobivena metodom najmanjih kvadrata prilagođena za početnu vrijednost p-vrijednost < 0,0001 u odnosu na placebo + peroralni lijek za snižavanje razine glukoze **p-vrijednost < 0,05 u odnosu na placebo + peroralni lijek za snižavanje razine glukoze
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Croatian: Omjer rizika kod usporedbe dapagliflozina i usporednog lijeka bio je 0,79 (95% intervala pouzdanosti
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: PRILOG 1 SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Metformin, one of the active substances in this medicine, can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called ‘lactic acidosis'.
Croatian: (može se javiti u do 1 na 10 000 osoba), ali ozbiljnu nuspojavu koja se naziva ‘laktacidozom'.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba) • žeđ
English: which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment.
Croatian: 1Metformin (oblici sa trenutnim ili produljenim oslobađanjem) ≥1500 mg/dan plus maksimalna podnošljiva doza sulfonilureje, koja mora biti najmanje pola maksimalne doze, tijekom najmanje 8 tjedana prije uključivanja u ispitivanje.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva bol u leđima*
English: Hypoglycaemia (when used with SU or insulin)b
Croatian: Poremećaji metabolizma i prehrane hipoglikemija (kad se primjenjuje sa sulfonilurejom ili inzulinom)b deplecija volumena,b,e žeđ**
English: Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side.
Croatian: Smeđe, bikonveksne, ovalne, filmom obložene tablete veličine 9,5 x 20 mm, s utisnutom oznakom
English: AstraZeneca Czech Republic s.r.o.
Croatian: AstraZeneca A.E.
English: Combination requiring precautions for use
Croatian: Prilagođeno za početnu vrijednost
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Croatian: Xigduo 5 mg/1000 mg tablete dapagliflozin/metforminklorid
English: EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Croatian: EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tableta (višestruko pakiranje) DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Volume depletionb,e Thirst**
Croatian: - ubrzano i duboko disanje - smetenost
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Croatian: Jedna tableta sadrži 5 mg dapagliflozina u obliku dapagliflozin propandiolhidrata i 1000 mg metforminklorida.
English: At Week 48 for metformin plus sitagliptin, the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.44% and 0.15%, respectively.
Croatian: -0,44% za dapagliflozin u dozi od 10 mg te 0,15% za placebo.
English: Strength Pharmaceutic al form
Croatian: Jačina Farmaceutski oblik
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Croatian: POPIS NAZIVA, FARMACEUTSKOG(IH) OBLIKA, JAČINE(A) LIJEK(OV)A, PUT(EV)A PRIMJENE, PODNOSITELJ(A) ZAHTJEVA / NOSITELJ(A) ODOBRENJA
English: Invented name/ Name
Croatian: Zaštićeno ime Naziv
English: Netherlands
Croatian: Holandija
English: Content (concentratio n)
Croatian: Put primjene Sastav (koncentracija)
English: Marketing authorisation holder
Croatian: Nositelj odobrenja Podnositelj zahtjeva
English: It is available as tablets (1 mg).
Croatian: Dostupan je u obliku tableta (1 mg).
English: This summary was last updated in 04-2016.
Croatian: Ovaj sažetak posljednji je put ažuriran u 04. 2016.
English: The full EPAR for Azilect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Azilect nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Azilect rasagiline
Croatian: Azilect razagilin
English: The standard dose of Azilect is one tablet once a day.
Croatian: Standardna doza Azilecta jedna je tableta jedanput dnevno.
English: The studies lasted 26 and 18 weeks, respectively.
Croatian: Ispitivanja su trajala 26, odnosno 18 tjedana.
English: Other information about Azilect
Croatian: Ostale informacije o lijeku Azilect
English: Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells.
Croatian: Neurotransmiteri su kemikalije koje živčane stanice upotrebljavaju za komunikaciju sa susjednim stanicama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Azilect na snazi u Europskoj uniji od 21. veljače 2005.
English: Azilect was more effective than placebo in all of the studies.
Croatian: Lijek Azilect bio je djelotvorniji od placeba u svim ispitivanjima.
English: Azilect must not be used in patients who have severe problems with their liver.
Croatian: Azilect se ne smije primjenjivati u bolesnika koji imaju ozbiljne probleme s jetrom.
English: Azilect is used to treat Parkinson's disease.
Croatian: Azilect se koristi za liječenje Parkinsonove bolesti.
English: This is a summary of the European public assessment report (EPAR) for Azilect.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Azilect.
English: The most common side effect with Azilect (seen in more than 1 patient in 10) is headache.
Croatian: Najčešća nuspojava lijeka Azilect (uočena u više od 1 na 10 bolesnika) je glavobolja.
English: 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).
Croatian: Glavno mjerilo djelotvornosti bila je promjena simptoma tijekom 26 tjedana, kako je procijenjeno na temelju standardne ljestvice (ujedinjena ljestvica za ocjenu Parkinsonove bolesti, UPDRS).
English: A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Croatian: Pad zbroja u skladu s UPDRS-om indicira poboljšanje simptoma, dok povećanje indicira njihovo pogoršanje.
English: 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.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Azilect.
English: There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Croatian: Mora proći najmanje 14 dana između prestanka liječenja lijekom Azilect i početka liječenja inhibitorima monoaminooksidaze ili petidinom.
English: For more information about treatment with Azilect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Azilect pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease.
Croatian: Azilect je ispitivan u trima glavnim ispitivanjima u kojima je sudjelovalo 1563 bolesnika s Parkinsonovom bolešću.
English: The main measure of effectiveness was the time spent in the ‘off' state during the day, as recorded in patients' diaries.
Croatian: Glavno mjerilo djelotvornosti bilo je vrijeme provedeno u lošem stanju tijekom dana, kako je zabilježeno u dnevnicima bolesnika.
English: This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Croatian: Ta je vrijednost uspoređena s porastom od 4,07 bodova u bolesnika koji su uzimali placebo, čija je početna vrijednost iznosila 24,54.
English: Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort.
Croatian: Azilect se ne smije uzimati s drugim inhibitorima monoaminooksidaze, uključujući lijekove i biljne pripravke pribavljene bez liječničkog recepta, kao što je gospina trava.
English: Azilect is a medicine that contains the active substance rasagiline.
Croatian: Azilect je lijek koji sadrži djelatnu tvar razagilin.
English: In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
Croatian: U ispitivanju u kojem je lijek Azilect primijenjen samostalno, bolesnici koji su uzimali dozu od 1 mg jedanput dnevno doživjeli su prosječan pad zbroja u skladu s UPDRS-om od 0,13 bodova tijekom 26-tjednog ispitivanja, u kojemu je početna vrijednost iznosila 24,69.
English: What is the risk associated with Azilect?
Croatian: Koji su rizici povezani s lijekom Azilect?
English: By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: Povećanjem razina dopamina u dijelovima mozga koji kontroliraju kretanje i koordinaciju, lijek Azilect poboljšava znakove i simptome Parkinsonove bolesti kao što su ukočenost i usporeno kretanje.
English: It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Croatian: Djeluje blokiranjem enzima monoaminooksidaze B, koji u mozgu razgrađuje neurotransmiter dopamin.