natgillin/translations-raw huggingface dataset:
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).
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).
For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8.
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.
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.
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.
C/ Castelló no1, Pol. Las Salinas 08830, Sant Boi de Llobregat, Barcelona Spain
Las Salinas 08830, Sant Boi de Llobregat, Barcelona Španija
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.
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.
In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Pri bolnikih s Parkinsonovo boleznijo, ki so kot dodatno terapijo stalno prejemali levodopo, ni bilo nobenega klinično pomembnega vpliva levodope na očistek razagilina.
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)
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)
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).
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).
In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
In vitro študije presnove so pokazale, da je citokrom P450 1A2 (CYP1A2) glavni encim, ki je odgovoren za presnavljanje razagilina.
In post-marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
V post-marketinških izkušnjah so prav tako zaznali navedene simptome pri bolnikih s Parkinsonovo boleznijo, ki so bili zdravljeni z razagilinom.
In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
V obdobju trženja je prišlo do enega primera zvišanega krvnega tlaka pri bolniku, ki je med jemanjem razagilina uporabljal očesni vazokonstriktor tetrahidrozolinijev klorid.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Sočasna uporaba razagilina in entakapona poveča peroralni očistek razagilina za 28%.
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.
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.
Hepatic impairment: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Okvara jeter: Pri osebah z blago jetrno okvaro sta AUC in Cmax porasla za 80% oz. 38%.
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.
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.
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.
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.
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.
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.
There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa.
Poročali so o hipotenzivnih učinkih pri sočasni uporabi razagilina z levodopo.
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).
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).
You should speak with your doctor about any suspicious skin changes.
O vsakih sumljivih kožnih spremembah se pogovorite z zdravnikom.
Adverse reactions with at least 2% difference over placebo are marked in italics.
Neželeni učinki z najmanj 2% razliko v primerjavi s placebom so napisani v poševni pisavi.
- The other ingredients are microcrystalline cellulose, tartric acid, maize starch, pregelatinized maize starch, talc, stearic acid.
Druge sestavine zdravila so mikrokristalna celuloza, vinska kislina, koruzni škrob, želatiniran koruzni škrob, smukec, stearinska kislina.
Rasagiline use in patients with moderate hepatic impairment should be avoided.
Uporabi razagilina pri bolnikih z zmerno jetrno okvaro se je potrebno izogibati.
White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE' on one side and ‘1' on the other side.
Bele do belkaste, podolgovate (približno 11,5 mm x 6 mm) bikonveksne tablete, z vtisnjenim ''R9SE'' na eni strani in ''1'' na drugi strani tablete.
Uncommon: angina pectoris (0.5% vs. 0%)
Občasni: angina pektoris (0,5% proti 0%)
Rasagiline must not be administered along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Razagilin se ne sme uporabljati sočasno z drugimi inhibitorji MAO (vključno z zdravili in naravnimi pripravki brez recepta, kot je npr. šentjanževka), ker obstaja tveganje, da neselektivna inhibicija monoaminooksidaze (MAO) lahko vodi do hipertenzivnih kriz (glejte poglavje 4.3).
Common: hallucinations (2.9% vs. 2.1%), abnormal dreams (2.1% vs. 0.8%) Uncommon: confusion (0.8% vs. 0.5%)
Pogosti: halucinacije (2,9% proti 2,1%), neobičajne sanje (2,1% proti 0,8%) Občasni: zmedenost (0,8% proti 0,5%)
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Uporaba razagilina pri bolnikih s hudo jetrno okvaro je kontraindicirana (glejte poglavje 4.3).
What Rasagiline Mylan is and what it is used for 2.
Kaj je zdravilo Razagilin Mylan in za kaj ga uporabljamo 2.
Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
Zaradi tega je s stališča inhibitorne monoaminooksidazne aktivnosti razagilina potrebno antidepresive uporabljati previdno.
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
V študiji II so bolniki naključno prejemali placebo (229 bolnikov) ali razagilin 1 mg/dan (231 bolnikov) ali katehol-o-metil-transferazni inhibitor (COMT), entakapon 200 mg, skupaj s predvidenimi odmerki levodope (LD)/dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
Very common: dyskinesia (10.5% vs. 6.2%)
Zelo pogosti: diskinezija (10,5% proti 6,2%)
Rasagiline Mylan with food and drink Rasagiline Mylan may be taken with or without food.
Zdravilo Razagilin Mylan skupaj s hrano in pijačo Zdravilo Razagilin Mylan lahko jemljete bodisi s hrano bodisi brez nje.
Common: dermatitis (2.0% vs. 0%)
Pogosti: dermatitis (2,0% proti 0%)
Experimental data indicated that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
Eksperimentalni podatki kažejo, da razagilin zavira izločanje prolaktina, to pa lahko zavre dojenje.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and reproduction toxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in reproduktivne toksičnosti ne kažejo posebnega tveganja za človeka.
Rasagiline was not carcinogenic in rats at systemic exposure, 84-339 times the expected plasma exposures in humans at 1 mg/day.
Razagilin pri sistemski izpostavljenosti pri podganah, ki je bila 84 do 339-kratna pričakovani plazemski izpostavljenosti pri človeku pri 1 mg/dan, ni bil kancerogen.
Ask your doctor for advice prior to driving or using machines.
Pred vožnjo ali uporabo strojev se posvetujte s svojim zdravnikom.
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=149, placebo group n=151).
Spodnji seznam vključuje neželene učinke, ki so bili z večjo incidenco sporočani v s placebom kontroliranih študijah pri bolnikih, ki so prejemali razagilin 1 mg/dan (skupina razagilina n = 149, skupina placeba n = 151).
Do not stop taking Rasagiline Mylan without first talking to your doctor.
Če ste prenehali jemati zdravilo Razagilin Mylan Ne prenehajte jemati zdravila Razagilin Mylan, ne da bi se prej pogovorili z zdravnikom.
Do not store above 25ºC.
Shranjujte pri temperaturi do 25 ºC.
Common: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%) Nervous system disorders
Pogosti: depresija (5,4% proti 2%), halucinacije (1,3% proti 0,7%) Bolezni živčevja
In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
V študiji III je bila v primerjavi s placebom povprečna razlika -0,94 ur, 95% CI [-1,36, -0,51]; p < 0,0001.
What Rasagiline Mylan is and what it is used for
Kaj je zdravilo Razagilin Mylan in za kaj ga uporabljamo
There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Obstajajo poročila o interakcijah zdravil pri sočasni uporabi dekstrometorfana in neselektivnih inhibitorjev MAO.
Conjugation of rasagiline and its metabolites was also found to be a major elimination pathway to yield glucuronides.
Ugotovljeno je, da je konjugacija razagilina in njegovih presnovkov glavna izločevalna pot nastalih glukuronidov.
What Rasagiline Mylan looks like and contents of the pack Rasagiline tablets are presented as white to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE' on one side and ‘1' on the other side.
Izgled zdravila Razagilin Mylan in vsebina pakiranja Tablete razagilina so bele do belkaste, podolgovate (približno 11,5 mm x 6 mm) bikonveksne tablete, z vtisnjenim ''R9SE'' na eni strani in ''1'' na drugi strani tablete.
In vitro experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism.
In vitro poskusi so pokazali, da sta obe poti presnove razagilina odvisni od citokrom P450 sistema, kjer je v njegovo presnovo zajet CYP1A2 kot glavni izoencim.
There were no cases of serotonin syndrome in the rasagiline clinical program in which 115 patients were exposed concomitantly to rasagiline and tricyclics and 141 patients were exposed to rasagiline and SSRIs/ SNRIs.
V kliničnem programu z razagilinom, v katerem je bilo 115 bolnikov izpostavljenih hkrati razagilinu in triciklikom, 141 bolnikov pa je bilo izpostavljenih razagilinu in SSRI/SNRI, ni bilo primerov serotoninskega sindroma.
If you are starting treatment with Rasagiline Mylan, you should wait at least 5 weeks after stopping fluoxetine treatment.
Če začenjate zdravljenje z zdravilom Razagilin Mylan, morate po prenehanju zdravljenja s fluoksetinom počakati vsaj 5 tednov.
What you need to know before you take Rasagiline Mylan 3.
Kaj morate vedeti, preden boste vzeli zdravilo Razagilin Mylan 3.
Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) the antibiotic ciprofloxacin used against infections the cough suppressant dextromethorphan sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Prosite zdravnika za nasvet, preden začnete hkrati z zdravilom Razagilin Mylan jemati katero od naslednjih zdravil: določeni antidepresivi (selektivni inhibitorji ponovnega privzema serotonina, selektivni inhibitorji ponovnega privzema serotonina-norepinefrina, triciklični ali tetraciklični antidepresivi), antibiotik ciprofloksacin, ki se uporablja proti okužbam, zdravilo za pomirjanje kašlja dekstrometorfan, simpatikomimetiki, kot so tisti, ki so prisotni v kapljicah za oči, nosnih ali peroralnih dekongestivih in zdravila proti prehladu, ki vsebujejo efedrin ali psevdoefedrin.
In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 26 weeks.
V študiji III so bolniki naključno prejemali placebo (159 bolnikov), razagilin 0,5 mg/dan (164 bolnikov) ali razagilin 1 mg/dan (149 bolnikov) ter bili zdravljeni 26 tednov.
Rasagiline Mylan
Razagilin Mylan
The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the rasagiline 1 mg group.
Povprečno celotno dnevno skrajšanje OFF časa je bilo v skupini z entakaponom (-0,80 ur, 95% CI [-1,20, -0,41]; p < 0,0001) podobno kot v skupini z razagilinom 1 mg/dan.
Common: dystonia (2.4% vs. 0.8%), carpal tunnel syndrome (1.3% vs. 0%), balance disorder (1.6% vs. 0.3%)
Pogosti: distonija (2,4% proti 0,8%), sindrom karpalnega tunela (1,3% proti 0%), motnje ravnotežja (1,6% proti 0,3%)
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.
Če začenjate zdravljenje s fluoksetinom ali fluvoksaminom, morate po prenehanju zdravljenja z zdravilom Razagilin Mylan počakati vsaj 14 dni.
If you take more Rasagiline Mylan than you should If you think that you may have taken too many Rasagiline Mylan tablets, contact your doctor or pharmacist immediately.
Če menite, da ste morda vzeli preveč tablet zdravila Razagilin Mylan, se morate nemudoma posvetovati z zdravnikom ali s farmacevtom.
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended (see section 4.5).
Sočasna uporaba razagilina in dekstrometorfana ali simpatikomimetikov, kot so tisti, ki so prisotni v nazalnih in peroralnih dekongestivih, ali zdravil proti prehladu, ki vsebujejo efedrin ali psevdoefedrin, ni priporočljiva (glejte poglavje 4.5).
In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144-213-times the expected plasma exposure in humans at 1 mg/day.
Pri miših so pri sistemski izpostavljenosti, ki je bila 144 do 213-kratna pričakovani plazemski izpostavljenosti pri človeku pri 1 mg/dan, opazovali povečano incidenco kombiniranega bronhiolarnega/alveolarnega adenoma in/ali karcinoma.
Synthon Hispania S.L., C/ Castelló no1, Pol. Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Spain
Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Španija
In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
V študiji II je bila povprečna razlika v številu ur, preživetih v »OFF« stanju v primerjavi s placebom0,78 ur, 95% CI [-1,18, -0,39 ], p = 0,0001.
In patients taking Rasagiline Mylan and/or other medications used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Pri bolnikih, ki jemljejo zdravilo Razagilin Mylan in/ali druga zdravila, ki se uporabljajo za zdravljenje Parkinsonove bolezni, so opazili vedenja, kot so kompulzije, obsesivne misli, odvisnost od iger na srečo, prekomerno zapravljanje denarja, impulzivno vedenje in nenormalna povečana spolna sla ali obsedenost s pretiranim predajanjem mislim ali občutkom v povezavi s spolnostjo.
Common: influenza (4.7% vs. 0.7%)
Pogosti: gripa (4,7% proti 0,7%)
Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), dry mouth (3.4% vs. 1.8%)
Pogosti: bolečina v trebuhu (4,2% proti 1,3%), zaprtje (4,2% proti 2,1%), siljenje na bruhanje in bruhanje (8,4% proti 6,2%), suha usta (3,4% proti 1,8%) Bolezni kože in podkožja
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister packs containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets.
Tablete so na voljo v pretisnih omotih v škatli po 7, 10, 28, 30, 100 in 112 tablet ali perforiranih enoodmernih pretisnih omotih iz PVC/PVDC/aluminija po 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 ali 112 x 1 tableto.
Other medicines and Rasagiline Mylan
Druga zdravila in zdravilo Razagilin Mylan
Therefore, in view of the MAO inhibitory activity of rasagiline, the concomitant administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Zaradi inhibitorne monoaminooksidazne aktivnosti razagilina sočasna uporaba razagilina in dekstrometorfana ni priporočljiva (glejte poglavje 4.4).
Severe hepatic impairment.
Huda jetrna okvara.
The following side effects have been reported in placebo controlled clinical trials:
V kliničnih študijah, nadzorovanimi s placebom, so poročali o naslednjih neželenih učinkih:
In the post-marketing period, cases of elevated blood pressure, including rare cases of hypertensive crisis associated with ingestion of unknown amounts of tyramine-rich foods, have been reported in patients taking rasagiline.
V obdobju trženja so pri bolnikih, ki so jemali razagilin, poročali o primerih zvišanega krvnega tlaka, vključno z redkimi primeri hipertenzivne krize, povezanih z zaužitjem neznane količine s tiraminom bogatih jedi.
In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively.
V oklepaju je incidenca neželenih učinkov (% bolnikov) pri razagilinu v primerjavi s placebom.
Rasagiline may be taken with or without food.
Razagilin se lahko jemlje s hrano ali brez nje.
Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5).
Sočasno zdravljenje z drugimi inhibitorji monoaminooksidaze (MAO) (vključno z zdravili in naravnimi pripravki brez recepta, kot je npr. šentjanževka) ali s petidinom (glejte poglavje 4.5).
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Najmanj 14 dni pa mora preteči med prekinitvijo zdravljenja z razagilinom in do začetka zdravljenja s fluoksetinom ali fluvoksaminom.
Renal impairment No change in dose is required for renal impairment.
Pri ledvičnih okvarah ni potrebno spreminjati odmerka.