natgillin/translations-raw huggingface dataset:
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4).
V primeru, da pri bolniku blaga jetrna okvara napreduje do zmerne, se mora zdravljenje z razagilinom prekiniti (glejte poglavje 4. 4).
No change in dosage is required for renal impairment.
Pri ledvičnih okvarah ni potrebno spreminjati odmerjanja.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1).
Concomitant treatment with other monoamine oxidase (MAO) inhibitors or pethidine (see section 4.5).
Sočasno zdravljenje z drugimi inhibitorji monoaminooksidaze (MAO) ali s petidinom (glejte poglavje 4. 5).
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
Najmanj 14 dni mora preteči med prekinitvijo zdravljenja z razagilinom in začetkom zdravljenja z inhibitorji MAO ali s petidinom.
Rasagiline is contraindicated in patients with severe hepatic insufficiency.
Razagilin je kontraindiciran pri bolnikih s hudo jetrno insuficienco.
2 4.4 Special warnings and precautions for use
2 4. 4 Posebna opozorila in previdnostni ukrepi
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
Sočasni uporabi razagilina in fluoksetina ali fluvoksamina se je potrebno izogibati (glejte poglavje 4. 5).
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medications 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).
During the clinical development programme the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
V času programa kliničnega razvoja je pojavnost primerov melanoma nakazovala možnost povezave z razagilinom.
The data collected suggests that Parkinson’ s disease, and not any drug in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Zbrani podatki nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
Pri bolnikih z blago jetrno insuficienco je ob začetku zdravljenja z razagilinom potrebna previdnost.
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
V primeru, da pri bolniku blaga jetrna okvara napreduje do zmerne, se mora zdravljenje z razagilinom prekiniti (glejte poglavje 5. 2).
Rasagiline should not be administered along with other MAO inhibitors 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, ker obstaja tveganje, da neselektivna inhibicija monoaminooksidaze (MAO) lahko vodi do hipertenzivnih kriz (glejte poglavje 4. 3).
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors as well as with another selective MAO-B inhibitor.
Ob sočasni uporabi petidina in inhibitorjev MAO, kot tudi drugih selektivnih inhibitorjev MAO- B, so poročali o resnih neželenih učinkih.
The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
Sočasna uporaba razagilina in petidina je kontraindicirana (glejte poglavje 4. 3).
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Sočasni uporabi razagilina in fluoksetina ali fluvoksamina se je potrebno izogibati (glejte poglavje 4. 4).
With MAO inhibitors as well as with another selective MAO-B inhibitor there have been reports of drug interactions with the concomitant use of sympathomimetic medicinal products.
Obstajajo poročila o medsebojnih interakcijah zdravil pri sočasni uporabi inhibitorjev MAO, kot tudi drugih selektivnih inhibitorjev MAO- B, in simpatikomimetičnimi zdravili.
Therefore, in view of the MAO inhibitory activity of rasagiline concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medications, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Zaradi inhibitorne monoaminooksidazne aktivnosti razagilina sočasna uporaba razagilina in simpatikomimetikov, kot so tisti, ki so prisotni v nazalnih in peroralnih dekongestivih ali zdravil proti prehladu, ki vključujejo efedrin ali psevdoefedrin, ni priporočljiva (glejte poglavje 4. 4).
There have been reports of drug 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.
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).
Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), tricyclic, tetracylic antidepressants and MAO inhibitors as well as with another selective MAO-B inhibitor.
Poročali so o resnih neželenih učinkih ob sočasni uporabi selektivnih inhibitorjev ponovnega privzema serotonina (SSRI- jev), tricikličnih in tetracikličnih antidepresivov in inhibitorjev MAO, kot tudi drugih selektivnih inhibitorjev MAO- B.
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.
Co-administration of rasagiline and
Sočasna uporaba razagilina in teofilina (substrat
3 theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
3 CYP1A2) ni vplivala na njuno farmakokinetiko.
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.
CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 in CYP4A9.
These results indicate that rasagiline’ s therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Glede na te rezultate ni verjetno, da bi terapevtske koncentracije razagilina klinično pomembno součinkovale s substrati teh encimov.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Sočasna uporaba razagilina in entakapona poveča oralni očistek razagilina za 28%.
Tyramine/ rasagiline interaction:
Interakcije tiramin/ razagilin:
Results of four 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.
Rezultati štirih 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.
Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
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.
In the rasagiline clinical program overall 1361 patients were treated with rasagiline for 3076.4 patient years.
V kliničnem programu razagilina je bilo 1361 bolnikov zdravljenih z razagilinom 3076, 4 bolnikovih let.
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 bolnikovih let in 539 bolnikov je prejemalo placebo 213 bolnikovih let.
Monotherapy 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).
Monoterapija 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).
Adverse reactions with at least 2% difference over placebo are marked in italics.
Neželene učinke z najmanj 2% razliko v primerjavi s placebom so napisane v poševni pisavi.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10) common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Neželeni učinki so navedeni glede na pogostnost ob upoštevanju sledečih dogovorov: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
Body as a Whole: very common: headache (14.1% vs.
Telo v celoti: zelo pogosti: glavobol (14, 1% vs.
11.9%) common: flu syndrome (6.0% vs.
11, 9%), pogosti: sindrom gripe (6, 0% vs.
0.7%), malaise (2.0% vs.
0, 7%), občutek slabosti in neugodja (2, 0% vs.
0%), neck pain (2.0% vs.
0%), bolečine v vratu (2, 0% vs.
0%), allergic reaction (1.3% vs.
0%), alergične reakcije (1, 3% vs.
0.7%), fever (2.7% vs.
1, 3%).
1.3%) Cardiovascular system: common: angina pectoris (1.3% vs.
4 Srčno žilni sistem: pogosti: angina pektoris (1, 3% vs.
0%) uncommon: cerebrovascular accident (0.7% vs.
0%), občasni: možgansko žilni dogodki (0, 7% vs.
0%), myocardial infarct (0.7% vs.
0%), miokardni infarkt (0, 7% vs.
4 Digestive System: common: dyspepsia (6.7% vs.
Prebavni sistem: pogosti: dispepsija (6, 7% vs.
4%), anorexia (1.3% vs.
4%), anoreksija:
0%) Haemic and lymphatic system: common: leucopenia (1.3% vs.
Krvni in limfatični sistem: pogosti: levkopenija (1, 3% vs.
0%) Musculoskeletal System: common: arthralgia (7.4% vs.
0%) Mišično- skeletni sistem: pogosti: bolečine v sklepih (7, 4% vs.
4%), arthritis (2.0% vs.
4%), artritis (2, 0% vs.
0.7%) Nervous System: common: depression (5.4% vs.
Živčni sistem: pogosti: depresija (5, 4% vs.
2%), vertigo (2.0% vs.
2%), vrtoglavica (2, 0% vs.
0.7%) Respiratory system: common: rhinitis (2.7% vs.
1, 3%).
1.3%) Special Senses: common: conjunctivitis (2.7% vs.
Posebna čutila: pogosti: konjuktivitis (2, 7% vs.
0.7%) Skin and appendages: common: contact dermatitis (1.3% vs.
Koža z adneksi: pogosti: kontaktni dermatitis (1, 3% vs.
0%), vesiculobullous rash (1.3% vs.
0%), vezikulobulozni izpuščaj (1, 3% vs.
0%), skin carcinoma (1.3% vs.
0%), kožni karcinom (1, 3% vs.
0.7%) Urogenital system: common: urinary urgency (1.3% vs.
Urogenitalni sistem: pogosti: siljenje na uriniranje (1, 3% vs.
Adjunct Therapy 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).
Dodatna terapija 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).
Adverse reactions with at least 2% difference over placebo are in italics.
Neželeni učinki z najmanj 2% razliko v primerjavi s placebom so napisane v poševni pisavi.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Neželeni učinki so navedeni glede na pogostnost ob upoštevanju sledečih dogovorov: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
Body as a Whole: common: abdominal pain (3.9% vs.
Telo v celoti: pogosti: abdominalne bolečine (3, 9% vs.
1.3%), accidental injury (primarily falls) (8.2% vs.
1, 3%), naključne poškodbe (v glavnem padci) (8, 2% vs.
5.2%), neck pain (1.6% vs.
5, 2%), bolečine v vratu (1, 6% vs.
0.5%) Cardiovascular System: common: postural hypotension (4.7% vs.
Srčno žilni sistem: pogosti: posturalna hipotenzija (4, 7% vs.
1.3%) uncommon: angina pectoris (0.5% vs.
1, 3%), občasni: angina pektoris (0, 5% vs.
0%), cerebrovascular accident (0.5% vs.
0%), možgansko žilni dogodki (0, 5% vs.
0.3%) Digestive System: common: constipation (4.2% vs.
Prebavni sistem: pogosti: zaprtje (4, 2% vs.
2.1%), vomiting (3.4% vs.
2, 1%), bruhanje (3, 4% vs.
1.0%), anorexia (2.1% vs.
1, 0%), neješčnost (2, 1% vs.
0.5%), dry mouth (3.4% vs.
0, 5%), suha usta (3, 4% vs.
1.8%) Musculoskeletal System: common: arthralgia (3.2% vs.
Mišično- skeletni sistem: pogosti: bolečine v sklepih (3, 2% vs.
1.3%), tenosynovitis (1.3% vs.
1, 3%), tenosinovitis (1, 3% vs.
0%) Metabolic and Nutritional: common: weight loss (4.2% vs.
Presnovne in prehranske: pogosti: zmanjšanje telesne mase (4, 2% vs.
1.5%) Nervous System: very common: dyskinesia (10.3% vs.
Živčni sistem: zelo pogosti: diskinezija (10, 3% vs.
6.4%) common: dystonia (2.4% vs.
6, 4%), pogosti: distonija (2, 4% vs.
0.8%), Abnormal dreams (2.1% vs.
0, 8%), nenavadne sanje (2, 1% vs.
0.8%), ataxia (1.3% vs.
0, 8%), ataksija (1, 3% vs.
0.3%), hallucinations (2.9% vs.
0, 3%), halucinacije (2, 9% vs.
2.1%), uncommon: confusion (0.8% vs.
2, 1%), občasni: zmedenost (0, 8% vs.
0.8%) Skin and appendages: common: rash (2.6% vs.
Koža z adneksi: pogosti: izpuščaj (2, 6% vs.
1.5%) uncommon: skin melanoma (0.5% vs.
1, 5%), občasni: kožni melanom (0, 5% vs.
Other important adverse events that were reported in clinical studies with rasagiline (other dose or in studies without placebo control) occurred in two patients each were rhabdomyolysis (both cases were following fall and prolonged immobilization) and inappropriate antidiuretic hormone (ADH) secretion.
Drugi pomembni neželeni učinki, ki so bili sporočani v kliničnih študijah z razagilinom (drugačni odmerki ali v študijah, ki niso bile kontrolirane s placebom) so se pojavili pri dveh bolnikih, ki sta imela rabdomiolizo (v obeh primerih sta sledila padca in podaljšana imobilizacija) in neustrezno izločanje antidiuretičnega hormona (ADH).
The complicated nature of these cases makes it impossible to determine what role, if any, rasagiline played in their pathogenesis.
Komplicirana narava teh primerov onemogoča opredelitev vloge, če sploh je, razagilina v njihovi patogenezi.
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.
Theoretically, overdose can cause significant inhibition of both MAO-A and MAO-B.
Teoretično lahko prekomerni odmerki povzročijo pomembno inhibicijo tako MAO- A kot MAO- B.
In a single-dose study healthy volunteers received 20 mg/ day and in a ten-day study healthy volunteers received 10 mg/ day.
V študiji z enojnimi odmerki so zdravi prostovoljci dobili odmerek 20 mg/ dan in v desetdnevni študiji so zdravi prostovoljci prejemali odmerek 10 mg/ dan.
In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/ day of rasagiline, there were reports of cardiovascular undesirable effects (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 učinkih
5 There is no specific antidote.
5 (vključno s hipertenzijo in posturalno hipotenzijo), ki pa so prešli po prekinitvi zdravljenja.
In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
Ti simptomi so lahko podobni simptomom, ki jih je mogoče opaziti pri neselektivnih inhibitorjih MAO.
Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors, ATC code:
Farmakoterapevtska skupina: antiparkinsoniki, zaviralci monoaminooksidaz tipa B, oznaka ATC:
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.
Razagilin se je pokazal kot močan, ireverzibilni selektivni inhibitor MAO- B, ki lahko povzroča povišanje izvencelične ravni dopamina v striatumu.
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
1- aminoindan je aktivni glavni presnovek in ni inhibitor MAO- B.
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/ day (134 patients) or rasagiline 2 mg/ day (132 patients) and were treated for 26 weeks, there was no active comparator.
V študiji I so bili 404 bolniki naključno razporejeni v skupine in prejemali placebo (138 bolnikov) ali 1 mg razagilina na dan (134 bolnikov) ali 2 mg razagilina na dan (132 bolnikov); zdravljeni so bili 26 tednov; aktivne primerjave ni bilo.
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 Scale - UPDRS, deli I- III).
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).
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Izražen je bil tudi pomemben in koristen učinek na kvaliteto življenja (ocenjeno s PD- QUALIF lestvico).
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) entakapone 200 mg, skupaj s predvidenimi odmerki levodope (LD) / dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
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.
In both studies the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “ OFF” state during the day (determined from “ 24-hour ” home diaries completed for 3 days prior to each of the assessment visits).
V obeh študijah je bilo primarno merilo učinkovitosti izhodiščna sprememba povprečnega števila ur v dnevu, preživetih v » OFF « stanju (opredeljenih iz » 24- urnih « domačih dnevnikov, ki so bili zaključeni 3 dni pred vsakim ocenjevalnim obiskom).
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 placebom - 0, 78 ur, 95% CI [- 1, 18, - 0, 39 ur], p = 0. 0001.
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.
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.
There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Moč rezultatov za primarno
The robustness of the results for the primary efficacy endpoint, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
6 merilo končne učinkovitosti je bila potrjena v bateriji dodatnih statističnih modelov in prikazana v treh kohortah (ITT, na protokol in zaključene).
6 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.
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.
Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Razagilin se hitro absorbira, vrh plazemske koncentracije (Cmax) doseže v približno v 0, 5 ure.
Food does not affect the Tmax of rasagiline, although Cmax and exposure (AUC) are decreased by approximately 60% and 20%, respectively, when the medicinal product is taken with a high fat meal.
20%, ko se zdravilo vzame z zelo mastnim obrokom.