FrancophonIA/ELRC3.0 huggingface dataset:
English: Rasagiline pharmacokinetics are linear with dose over the range of 0.5-2 mg. Its terminal half-life is 0.6-2 hours.
Slovenian: Farmakokinetika razagilina je linearna pri odmerkih od 0,5 do 2 mg. Njegov končni razpolovni čas je 0,6 do 2 uri.
English: During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
Slovenian: V času programa kliničnega razvoja je pojavnost primerov melanoma nakazovala možnost povezave z razagilinom.
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Neželeni učinki so navedeni glede na pogostnost ob upoštevanju sledečih dogovorov: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: For rasagiline no clinical data on exposed pregnancies is available.
Slovenian: Za razagilin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: It is not known whether rasagiline is excreted in human milk.
Slovenian: Ni znano, ali se razagilin izloča v materino mleko.
English: The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as adjunct therapy to levodopa in the studies II and III.
Slovenian: Učinkovitost razagilina je bila ugotovljena v treh študijah: kot monoterapija v študiji I in kot dodatna terapija k levodopi v študijah II in III.
English: The secondary measures of efficacy included global assessments of improvement by the examiner, Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON. Rasagiline produced statistically significant benefit compared to placebo.
Slovenian: Sekundarna merila učinkovitosti so vključevala ocenjevalčevo globalno oceno izboljšanja, dosežene točke na podlestvici Vprašalnika vsakodnevnih aktivnosti (Activities of Daily Living -ADL) v času OFF in motorični UPDRS v času ON. Razagilin je dosegel statistično pomembno korist v primerjavi s placebom.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors, ATC code: N04BD02
Slovenian: Farmakoterapevtska skupina: antiparkinsoniki, zaviralci monoaminooksidaz tipa B, oznaka ATC: N04BD02
English: 1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
Slovenian: 1-aminoindan je aktivni glavni presnovek in ni inhibitor MAO-B.
English: Overdose can be associated with significant inhibition of both MAO-A and MAO-B.
Slovenian: Preveliki odmerki so lahko povezani s pomembno inhibicijo tako MAO-A kot MAO-B.
English: Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum.
Slovenian: Razagilin se je pokazal kot močan, ireverzibilen selektiven inhibitor MAO-B, ki lahko povzroča povišanje izvencelične ravni dopamina v striatumu.
English: Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain.
Slovenian: Zdravilo Razagiline Mylan pomaga zvišati in vzdrževati raven dopamina v možganih.
English: A similar pattern of impulse control disorders has been reported post-marketing with rasagiline, which also included compulsions, obsessive thoughts and impulsive behaviour (see section 4.4).
Slovenian: O podobnem vzorcu motenj nadzora impulzov so poročali v obdobju trženja z razagilinom, ki je vključeval tudi kompulzije, obsesivne misli in impulzivno vedenje (glejte poglavje 4.4).
English: There are a number of known interactions between non-selective MAO inhibitors and other medicinal products.
Slovenian: Obstajajo številne znane interakcije med neselektivnimi inhibitorji MAO in drugimi zdravili.
English: These symptoms may resemble those observed with non-selective MAO inhibitors.
Slovenian: Ti simptomi so lahko podobni simptomom, ki jih je mogoče opaziti pri neselektivnih inhibitorjih MAO.
English: In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 3,076.4 patient years.
Slovenian: V kliničnem programu razagilina je bilo 1.361 bolnikov zdravljenih z razagilinom 3.076,4 bolnikovlet.
English: C-labelled rasagiline, elimination occurred primarily via urine (62.6%) and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 38 days.
Slovenian: C-označenim razagilinom nastopi izločanje v glavnem preko urina (62,6%) in sekundarno preko blata (21,8%), s celotnim izločanjem 84,4% odmerka v obdobju 38 dni.
English: 117, Allée des Parcs, 69800 Saint-Priest France
Slovenian: 117, Allée des Parcs, 69800 Saint-Priest Francija
English: With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.
Slovenian: Pri Parkinsonovi bolezni nastopi izguba celic, ki v določenih možganskih področjih tvorijo dopamin.
English: In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
Slovenian: Pri osebah z zmerno jetrno okvaro sta AUC in Cmax porasla za 568% oz. 83% (glejte poglavje 4.4).
English: The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate rasagiline's beneficial effects seen in models of dopaminergic motor dysfunction.
Slovenian: Povišana raven dopamina in posledično povečana dopaminergična aktivnost verjetno prenašata koristne učinke razagilina, opazovane v modelih dopaminergičnih motoričnih disfunkcij.
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-Aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Slovenian: Presnova razagilina poteka preko dveh glavnih poti: N-dealkilacije in/ali hidroksilacije do presnovkov: 1-aminoindana, 3-hidroksi-Npropargil-1 aminoindana in 3-hidroksi-1-aminoindana.
English: 117, Allée des Parcs 69800 Saint-Priest France
Slovenian: 117, Allée des Parcs 69800 Saint-Priest Francija
English: It can be used together with or without levodopa (another medicine that is used to treat Parkinson's disease).
Slovenian: Lahko se ga uporablja z levodopo (drugo zdravilo za zdravljenje Parkinsonove bolezni) ali brez nje.
English: Thus, potent CYP1A2 inhibitors may alter rasagiline plasma levels and should be administered with caution.
Slovenian: Močni inhibitorji CYP1A2 lahko torej spremenijo plazemske ravni razagilina, zaradi česar se morajo uporabljati previdno.
English: Plasma protein binding following a single oral dose of
Slovenian: Plazemska proteinska vezava, ki sledi enojnemu odmerku s
English: There have been cases of patients who, while taking one or more medications for the treatment of Parkinson's disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others.
Slovenian: Znani so primeri, ko so se bolniki med jemanjem enega ali več zdravil za zdravljenje Parkinsonove bolezni bili nezmožni upirati nagibom, željam ali skušnjavam, da bi izvajali določene dejavnosti, ki bi lahko bile škodljive za njih same ali za druge.
English: C-labelled rasagiline is approximately 60 to
Slovenian: C-označenim razagilinom, je približno
English: Because AUC is not substantially affected, rasagiline can be administered with or without food.
Slovenian: Ker AUC ni bistveno spremenjen, se razagilin lahko jemlje s hrano ali brez nje.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 7 x 1 tablets 10 x 1 tablets 28 x 1 tablets 30 x 1 tablets 100 x 1 tablets 112 x 1 tablets
Slovenian: 7 tablet 10 tablet 28 tablet 30 tablet 100 tablet 112 tablet 7 x 1 tableta 10 x 1 tableta 28 x 1 tableta 30 x 1 tableta 100 x 1 tableta 112 x 1 tableta
English: The use of Rasagiline Mylan together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Slovenian: Potrebno se je izogibati uporabi zdravila Razagilin Mylan skupaj z antidepresivi, ki vsebujejo fluoksetin ali fluvoksamin.
English: Impulse control disorders
Slovenian: Motnje pri obvladovanju impulzov
English: Take the Rasagiline Mylan carton with you to show the doctor or pharmacist.
Slovenian: S seboj vzemite škatlo zdravila Razagilin Mylan, da jo boste lahko pokazali zdravniku ali farmacevtu.
English: Manufacturer Mylan Hungary Kft, Mylan utca 1
Slovenian: Izdelovalec Mylan Hungary Kft, Mylan utca 1
English: In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Slovenian: Prav tako so, pri približno 1% bolnikov v s placebom nadzorovanih kliničnih preskušanjih, poročali o kožnem karcinomu.
English: Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Tyramine/rasagiline interaction: Results of five tyramine challenge studies (in volunteers and PD patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Slovenian: Interakcije tiramin/razagilin: Rezultati petih izmenjalnih študij s tiraminom (pri prostovoljcih in bolnikih s Parkinsonovo boleznijo), skupaj z rezultati spremljanja krvnega pritiska po obrokih hrane v domačem okolju (464 bolnikov zdravljenih z 0,5 ali 1 mg/dan razagilina ali placeba kot dodatne šest mesečne terapije k levodopi brez omejitve tiramina) in dejstva, da ni poročil o interakcijah tiramin/razagilin v kliničnih študijah, ki so bile izvajane brez omejitve tiramina, kažejo na to, da se lahko razagilin varno uporablja brez dietne omejitve tiramina.
English: Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others.
Slovenian: Zdravniku povejte, če sami ali kdo v vaši družini ali vaš skrbnik opazi za vas neobičajno vedenje, da se ne morete upirati nagibom, željam ali skušnjavi, da bi izvajali določene dejavnosti, ki so lahko škodljive za vas ali druge.
English: Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased and pre-existing dyskinesia exacerbated.
Slovenian: Ker razagilin poveča učinke levodope, se lahko neželeni učinki levodope povečajo in obstoječa diskinezija poslabša.
English: These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Slovenian: Glede na te rezultate ni verjetno, da bi terapevtske koncentracije razagilina klinično pomembno součinkovale s substrati teh encimov.
English: Nevertheless, scientific evidence suggests that Parkinson's disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Slovenian: Vendar pa znanstveni dokazi nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
English: There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Slovenian: Obstaja možnost, da so pri kadilcih znižane plazemske ravni razagilina zaradi indukcije metabolnega encima CYP1A2.
English: These are called impulse control disorders.
Slovenian: Tako vedenje imenujemo motnje pri obvladovanju impulzov.
English: Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline.
Slovenian: Vsaka tableta vsebuje razagilinijev tartrat, kar ustreza 1 mg razagilina.
English: Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Slovenian: Simptomi, ki so jih navajali pri prevelikem odmerku razagilina pri odmerkih od 3 mg do 100 mg, so vključevali disforijo, hipomanijo, hipertenzivno krizo in serotoninski sindrom.
English: The data collected suggests that Parkinson's disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Slovenian: Zbrani podatki nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z višjim tveganjem karcinoma kože (ne izključno melanoma).
English: Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Slovenian: Zdravilo Razagilin Mylan je indicirano za zdravljenje idiopatske Parkinsonove bolezni (PB) kot monoterapija (brez levodope) ali kot dodatna terapija (z levodopo) pri bolnikih z nihanji končnih odmerkov.
English: Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Slovenian: Sočasna uporaba razagilina in ciprofloksacina (inhibitor CYP1A2) je povečala AUC razagilina za 83%.
English: Do not take Rasagiline Mylan: - if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Razagiline Mylan: če ste alergični na razagilin ali katero koli sestavino tega zdravila (navedeno v poglavju 6), če imate hude težave z jetri.
English: Co-administration of rasagiline and theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
Slovenian: Sočasna uporaba razagilina in teofilina (substrat CYP1A2) ni vplivala na njuno farmakokinetiko.
English: In the presence of metabolite activation rasagiline induced an increase of chromosomal aberrations at concentrations with excessive cytotoxicity which are unattainable at the clinical conditions of use.
Slovenian: Razagilin v prisotnosti aktivacije metabolita povzroča porast kromosomskih aberacij v koncentracijah z obsežno citotoksičnostjo, ki v kliničnih pogojih uporabe niso dosežene.
English: The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Slovenian: Razlika med povprečno spremembo od izhodišča do 26 tedna/zaključka (Zadnje opazovanje preneseno vnaprej; Last Observation Carried Forward - LOCF) je bila statistično pomembna (UPDRS, deli I-III: za razagilin 1 mg v primerjavi s placebom -4,2, 95% CI [-5,7, -2,7]; p < 0,0001; za razagilin 2 mg v primerjavi s placebom -3,6, 95% CI [-5,0, -2,1]; p < 0,0001; UPDRS motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7, 95% CI [-3,87, -1,55]; p < 0,0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95% CI [-2,85, -0,51]; p = 0,0050).
English: For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8.
Slovenian: Za sočasno uporabo razagilina in selektivnih inhibitorjev ponovnega privzema serotonina (SSRI)/selektivnih inhibitorjev ponovnega privzema serotonina-norepinefrina (SNRI) v kliničnih študijah glejte poglavje 4.8.
English: In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular undesirable reactions (including hypertension and postural hypotension) which resolved following treatment discontinuation.
Slovenian: Iz študije višanja odmerkov pri bolnikih s kronično terapijo z levodopo in ki so bili zdravljeni z 10 mg/dan razagilina, so poročila o srčno žilnih neželenih odzivih (vključno s hipertenzijo in posturalno hipotenzijo), ki pa so prešli po prekinitvi zdravljenja.
English: C/ Castelló no1, Pol. Las Salinas 08830, Sant Boi de Llobregat, Barcelona Spain
Slovenian: Las Salinas 08830, Sant Boi de Llobregat, Barcelona Španija
English: Renal impairment: Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
Slovenian: Okvara ledvic: Farmakokinetične lastnosti razagilina so bile pri osebah z blago (očistek kreatinina (CLcr) 50 - 80 ml/min) in zmerno (CLcr 30 - 49 ml/min) okvaro ledvic podobne kot pri zdravih osebah.
English: In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo, ki so kot dodatno terapijo stalno prejemali levodopo, ni bilo nobenega klinično pomembnega vpliva levodope na očistek razagilina.
English: EU/1/16/1090/001 (7 tablets - oPA/alu/PVC/alu) EU/1/16/1090/002 (10 tablets - oPA/alu/PVC/alu) EU/1/16/1090/003 (28 tablets - oPA/alu/PVC/alu) EU/1/16/1090/004 (30 tablets - oPA/alu/PVC/alu) EU/1/16/1090/005 (100 tablets - oPA/alu/PVC/alu) EU/1/16/1090/006 (112 tablets - oPA/alu/PVC/alu) EU/1/16/1090/007 (7 tablets - PVC/PVDC/alu) EU/1/16/1090/008 (10 tablets - PVC/PVDC/alu) EU/1/16/1090/009 (28 tablets - PVC/PVDC/alu) EU/1/16/1090/010 (30 tablets - PVC/PVDC/alu) EU/1/16/1090/011 (100 tablets - PVC/PVDC/alu) EU/1/16/1090/012 (112 tablets - PVC/PVDC/alu) EU/1/16/1090/013 (7 tablets - PVC/PVDC/alu) EU/1/16/1090/014 (10 tablets - PVC/PVDC/alu) EU/1/16/1090/015 (28 tablets - PVC/PVDC/alu) EU/1/16/1090/016 (30 tablets - PVC/PVDC/alu) EU/1/16/1090/017 (100 tablets - PVC/PVDC/alu) EU/1/16/1090/018 (112 tablets - PVC/PVDC/alu)
Slovenian: EU/1/16/1090/001 (7 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/002 (10 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/003 (28 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/004 (30 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/005 (100 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/006 (112 tablet - oPA/aluminij/PVC/aluminij) EU/1/16/1090/007 (7 tablet - PVC/PVDC/aluminij) EU/1/16/1090/008 (10 tablet - PVC/PVDC/aluminij) EU/1/16/1090/009 (28 tablet - PVC/PVDC/aluminij) EU/1/16/1090/010 (30 tablet - PVC/PVDC/aluminij) EU/1/16/1090/011 (100 tablet - PVC/PVDC/aluminij) EU/1/16/1090/012 (112 tablet - PVC/PVDC/aluminij) EU/1/16/1090/013 (7 x 1 tableta - PVC/PVDC/aluminij) EU/1/16/1090/014 (10 x 1 tableta - PVC/PVDC/aluminij) EU/1/16/1090/015 (28 x 1 tableta - PVC/PVDC/aluminij) EU/1/16/1090/016 (30 x 1 tableta - PVC/PVDC/aluminij) EU/1/16/1090/017 (100 x 1 tableta - PVC/PVDC/aluminij) EU/1/16/1090/018 (112 x 1 tableta - PVC/PVDC/aluminij)
English: In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS, parts I-III).
Slovenian: V tej študiji je bilo primarno merilo učinkovitosti doseženo število točk glede na izhodišče na Združeni ocenjevalni lestvici Parkinsonove bolezni (Unified Parkinson's Disease Rating ScaleUPDRS, deli I-III).
English: In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
Slovenian: In vitro študije presnove so pokazale, da je citokrom P450 1A2 (CYP1A2) glavni encim, ki je odgovoren za presnavljanje razagilina.
English: In post-marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
Slovenian: V post-marketinških izkušnjah so prav tako zaznali navedene simptome pri bolnikih s Parkinsonovo boleznijo, ki so bili zdravljeni z razagilinom.
English: In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
Slovenian: V obdobju trženja je prišlo do enega primera zvišanega krvnega tlaka pri bolniku, ki je med jemanjem razagilina uporabljal očesni vazokonstriktor tetrahidrozolinijev klorid.
English: Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Slovenian: Sočasna uporaba razagilina in entakapona poveča peroralni očistek razagilina za 28%.
English: In vitro studies showed that rasagiline at a concentration of 1 μg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Slovenian: In vitro študije so pokazale, da razagilin v koncentraciji 1 μg/ml (ekvivalent ravni, ki je 160-kratna povprečna Cmax ~ 5,9 - 8,5 ng/ml pri bolnikih s Parkinsonovo boleznijo po zaužitju večkratnih odmerkov 1 mg razagilina) ne inhibira izoencimov citokroma P450: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 in CYP4A9.
English: Hepatic impairment: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Slovenian: Okvara jeter: Pri osebah z blago jetrno okvaro sta AUC in Cmax porasla za 80% oz. 38%.
English: In the double blind placebo-controlled studies, 529 patients were treated with rasagiline 1 mg/day for 212 patient years and 539 patients received placebo for 213 patient years.
Slovenian: V dvojno slepih, s placebom kontroliranih študijah je bilo 529 bolnikov zdravljenih z razagilinom 1 mg/dan 212 bolnikov-let in 539 bolnikov je prejemalo placebo 213 bolnikov-let.
English: Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily.
Slovenian: V kliničnih preskušanjih z razagilinom niso smeli sočasno uporabljati fluoksetina ali fluvoksamina z razagilinom, lahko pa so bili uporabljeni naslednji antidepresivi in odmerki: amitriptilin ≤ 50 mg dnevno, trazodon ≤ 100 mg dnevno, citalopram ≤ 20 mg dnevno, sertralin ≤ 100 mg dnevno in paroksetin ≤ 30 mg dnevno.
English: Patients and carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated with rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Slovenian: Bolnike in njihove skrbnike je treba opozoriti na vedenjske simptome motenj pri obvladovanju impulzov, ki so bili opaženi pri bolnikih, ki so se zdravili z razagilinom, kar vključuje primere kompulzije, obsesivne misli, patološkega hazardiranja, povečanega libida, hiperseksualnosti, impulzivnega vedenja in kompulzivnega zapravljanja ali nakupovanja.
English: There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa.
Slovenian: Poročali so o hipotenzivnih učinkih pri sočasni uporabi razagilina z levodopo.
English: The list below includes adverse reactions which were reported with a higher incidence in placebo controlled studies in patients receiving 1 mg/day rasagiline (rasagiline group n=380, placebo group n=388).
Slovenian: Spodnji seznam vključuje neželene učinke, ki so bili sporočani z večjo incidenco v s placebom kontroliranih študijah pri bolnikih, ki so prejemali razagilin 1 mg/dan (skupina razagilina n = 380, skupina placeba n = 388).
English: Nederland Mylan BV
Slovenian: Mylan BV
English: You should speak with your doctor about any suspicious skin changes.
Slovenian: O vsakih sumljivih kožnih spremembah se pogovorite z zdravnikom.
English: Adverse reactions with at least 2% difference over placebo are marked in italics.
Slovenian: Neželeni učinki z najmanj 2% razliko v primerjavi s placebom so napisani v poševni pisavi.