natgillin/translations-raw huggingface dataset:
The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate rasagiline's beneficial effects seen in models of dopaminergic motor dysfunction.
Povišena razina dopamina i posljedična povećana dopaminergička aktivnost vjerojatno posreduju korisne učinke razagilina viđene u modelima dopaminergičke motorne disfunkcije.
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).
U postmarketinškom razdoblju je prijavljen sličan model poremećaja kontrole impulsa sa razagilinom, što je također uključivalo kompulzije, opsesivne misli i impulzivno ponašanje (vidjeti dio 4.4).
The absolute bioavailability of a single rasagiline dose is about 36%.
Apsolutna bioraspoloživost pojedinačne doze razagilina je oko 36%.
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.
Vašeg liječnika ako Vi ili Vaša obitelj/skrbnik primijetite da razvijate neuobičajeno ponašanje u smislu da se ne možete oduprijeti nagonu, potrebi ili žudnji za obavljanjem određenih aktivnosti, škodljivih ili loših za Vas ili druge.
Rasagiline undergoes almost complete biotransformation in the liver prior to excretion.
Razagilin se gotovo potpuno biotransformira u jetri prije izlučivanja.
In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 3,076.4 patient years.
U kliničkom programu s razagilinom je ukupno 1361 bolesnik bio liječen razagilinom kroz 3076,4 bolesničkih godina.
Children and adolescents Rasagiline Mylan is not recommended for use under the age of 18.
Ne preporučuje se primjena lijeka Rasagiline Mylan u djece mlađe od 18 godina.
117, Allée des Parcs, 69800 Saint-Priest France
117, Allée des Parcs, 69800 Saint-Priest Francuska
Rasagiline was not carcinogenic in rats at systemic exposure, 84-339 times the expected plasma exposures in humans at 1 mg/day.
Razagilin nije bio kancerogen u štakora pri sistemskoj ekspoziciji 84-339 puta većoj od očekivane plazmatske ekspozicije u ljudi pri dozi od 1 mg/dan.
Thus, potent CYP1A2 inhibitors may alter rasagiline plasma levels and should be administered with caution.
Prema tome, potentni CYP1A2 inhibitori mogu promijeniti razine razagilina u plazmi i moraju se primjenjivati s oprezom.
These are called impulse control disorders.
Ovo se zove poremećaj kontrole impulsa.
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.
Pokazalo se da je razagilin potentan, ireverzibilan MAO-B selektivni inhibitor koji može prouzročiti povećanje izvanstanične razine dopamina u strijatumu.
Impulse control disorders
Poremećaji kontrole impulsa
Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased and pre-existing dyskinesia exacerbated.
Budući da razagilin pojačava učinke levodope, nuspojave levodope mogu se povećati i već postojeća diskinezija pogoršati.
Experimental data indicated that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
Eksperimentalni podaci pokazuju da razagilin inhibira sekreciju prolaktina i prema tome, može inhibirati laktaciju.
Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
Stoga se, s obzirom na MAO inhibitornu aktivnost razagilina, antidepresivi moraju primjenjivati s oprezom.
117, Allée des Parcs 69800 Saint-Priest France
117, Allée des Parcs 69800 Saint-Priest Francuska
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.
Hrana ne utječe na Tmax razagilina, iako je Cmax smanjen za približno 60%, a izloženost (AUC) za približno 20% kada se lijek uzima s obrokom s visokim udjelom masnoća.
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
Aktivni glavni metabolit je 1-aminoindan koji nije MAO-B inhibitor.
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.
Tiramin/razagilin interakcija: Rezultati iz pet ispitivanja izloženosti tiraminu (u dobrovoljaca i bolesnika s PB), zajedno s rezultatima kućnog nadziranja krvnog tlaka nakon obroka (464 bolesnika liječenih s 0,5 ili 1 mg/dan razagilina ili placebom kao dodatnom terapijom levodopi kroz šest mjeseci bez restrikcija tiramina) i činjenicom da nije bilo prijava tiramin/razagilin interakcija u kliničkim ispitivanjima provedenim bez restrikcije tiramina, upućuju na to da se razagilin može primijenjivati sigurno bez dijetalnih restrikcija tiramina.
• chest pain (angina pectoris)
• bol u prsima (angina pektoris)
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.
Rasagiline Mylan je indiciran za liječenje idiopatske Parkinsonove bolesti (PB) kao monoterapija (bez levodope) ili kao dodatna terapija (s levodopom) u bolesnika s fluktuacijama prilikom isteka doze.
Impulse control disorders (ICDs) can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Poremećaji kontrole impulsa se mogu pojaviti kod bolesnika liječenih agonistima dopamina i/ili dopaminergičkim lijekovima.
• decreased weight
• smanjenje tjelesne težine
The use of Rasagiline Mylan together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Istodobna primjena lijeka Rasagiline Mylan s antidepresivima koji sadrže fluoksetin ili fluvoksamin mora se izbjegavati.
Manufacturer Mylan Hungary Kft, Mylan utca 1
Proizvođač Mylan Hungary Kft, Mylan utca 1
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA
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 tableta - OPA/Al/PVC/Al) EU/1/16/1090/002 (10 tableta - OPA/Al/PVC/Al) EU/1/16/1090/003 (28 tableta - OPA/Al/PVC/Al) EU/1/16/1090/004 (30 tableta - OPA/Al/PVC/Al) EU/1/16/1090/005 (100 tableta - OPA/Al/PVC/Al) EU/1/16/1090/006 (112 tableta - OPA/Al/PVC/Al) EU/1/16/1090/007 (7 tableta - PVC/PVDC/Al) EU/1/16/1090/008 (10 tableta - PVC/PVDC/Al) EU/1/16/1090/009 (28 tableta - PVC/PVDC/Al) EU/1/16/1090/010 (30 tableta - PVC/PVDC/Al) EU/1/16/1090/011 (100 tableta - PVC/PVDC/Al) EU/1/16/1090/012 (112 tableta - PVC/PVDC/Al) EU/1/16/1090/013 (7 x 1 tableta - PVC/PVDC/Al) EU/1/16/1090/014 (10 x 1 tableta - PVC/PVDC/Al) EU/1/16/1090/015 (28 x 1 tableta - PVC/PVDC/Al) EU/1/16/1090/016 (30 x 1 tableta - PVC/PVDC/Al) EU/1/16/1090/017 (100 x 1 tableta - PVC/PVDC/Al) EU/1/16/1090/018 (112 x 1 tableta - PVC/PVDC/Al)
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.
Nakon peroralne primjene 14C-označenog razagilina, eliminacija se primarno odvija urinom (62,6%), a sekundarno putem fecesa (21,8%), s potpunim izlučivanjem 84,4% doze lijeka tijekom razdoblja od 38 dana.
Rasagiline Mylan with food and drink Rasagiline Mylan may be taken with or without food.
Rasagiline Mylan s hranom i pićem Rasagiline Mylan se može uzimati sa ili bez hrane.
What Rasagiline Mylan is and what it is used for 2.
Što je Rasagiline Mylan i za što se koristi 2.
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).
Nuspojave su poredane prema učestalosti javljanja koristeći sljedeće pravilo: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko
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.
U miševa je opažena povećana incidencija kombiniranih bronhiolarnih/alveolarnih adenoma i/ili karcinoma pri sistemskim ekspozicijama 144-213 puta većim od očekivane plazmatske ekspozicije u ljudi pri dozi od 1 mg/dan.
Characteristics in patients
Osobitosti kod bolesnika
There are a number of known interactions between non-selective MAO inhibitors and other medicinal products.
Poznate su brojne interakcije između neselektivnih MAO inhibitora i drugih lijekova.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza „Rok valjanosti“.
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.
Prilikom aktivacije metabolita razagilin je inducirao porast kromosomskih aberacija u koncentracijama s prekomjernom citotoksičnošću, koje se ne mogu postići u kliničkim uvjetima primjene.
In patients taking rasagiline and/or other medications used to treat Parkinson's disease, the following have been observed: Obsessive thoughts or impulsive behaviour.
Kod bolesnika koji uzimaju razagilin i/ili druge lijekove koji se koriste za liječenje Parkinsonove bolesti opaženo je sljedeće: Opsesivne misli ili impulzivno ponašanje.
What Rasagiline Mylan is and what it is used for
Što je Rasagiline Mylan i za što se koristi
Do not stop taking Rasagiline Mylan without first talking to your doctor.
Ako prestanete uzimati Rasagiline Mylan Nemojte prestati uzimati Rasagiline Mylan prije razgovora sa svojim liječnikom.
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.
U ispitivanju postupnog povećavanja doze kod bolesnika na kroničnoj terapiji levodopom liječenih s 10 mg/dan razagilina prijavljene su neželjene kardiovaskularne reakcije (uključujući hipertenziju i posturalnu hipotenziju) koje su se povukle po prestanku liječenja.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I DJELOTVORNU PRIMJENU LIJEKA
Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Istodobna primjena razagilina i ciprofloksacina (inhibitora CYP1A2) je povećala AUC razagilina za 83%.
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.
U kliničkim ispitivanjima razagilina nije bila dozvoljena istodobna upotreba fluoksetina ili fuvoksamina s razagilinom, ali sljedeći antidepresivi i doze bili su dozvoljeni u ispitivanjima razagilina: amitriptilin ≤ 50 mg/dnevno, trazodon ≤ 100 mg/dnevno, citalopram ≤ 20 mg/dnevno, sertralin ≤ 100 mg/dnevno i paroksetin ≤ 30 mg/dnevno.
In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
U postmarketinškom razdoblju bio je jedan slučaj povišenog krvnog tlaka u bolesnika koji je primijenjivao oftalmički vazokonstriktor tetrahidrozolinklorid tijekom uzimanja razagilina.
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).
Ipak, znanstveni dokazi upućuju na to da je Parkinsonova bolest, a ne neki lijek posebno, povezana s većim rizikom od karcinoma kože (ne isključivo melanom).
• runny nose (rhinitis)
• curenje nosa (rinitis)
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
7 tableta 10 tableta 28 tableta 30 tableta 100 tableta 112 tableta 7 x 1 tableta 10 x 1 tableta 28 x 1 tableta 30 x 1 tableta 100 x 1 tableta 112 x 1 tableta
Co-administration of rasagiline and theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
Istodobna primjena razagilina i teofilina (supstrata CYP1A2) nije utjecala na farmakokinetiku nijednog od dvaju navedenih lijekova.
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.
Oštećenje bubrega: Karakteristike farmakokinetike razagilina u osoba s blagim (CLcr 50-80 ml/min) i umjerenim (CLcr 30-49 ml/min) oštećenjem bubrega su slične onima zdravih osoba.
Adverse reactions with at least 2% difference over placebo are marked in italics.
Nuspojave s najmanje 2% razlike u odnosu na placebo su označene kurzivom.
Other medicines and Rasagiline Mylan
Drugi lijekovi i Rasagiline Mylan
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.
U postmarketinškom razdoblju su prijavljeni slučajevi povišenog krvnog tlaka, uključujući i rijetke slučajeve hipertenzivne krize povezane s ingestijom nepoznatih količina hrane bogate tiraminom u bolesnika koji su uzimali razagilin.
Do not take Rasagiline Mylan: - if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Rasagiline Mylan: ako ste alergični na razagilin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.1) ako imate teške probleme s jetrom.
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).
Prikupljeni podaci upućuju na to da je Parkinsonova bolest, a ne neki određeni lijekovi, povezana s većim rizikom od karcinoma kože (ne isključivo melanoma).
In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
U osoba s umjerenim oštećenjem jetre, AUC se povećava za 568%, a Cmax za 83% (vidjeti dio 4.4).
C/ Castelló no1, Pol. Las Salinas 08830, Sant Boi de Llobregat, Barcelona Spain
Las Salinas 08830, Sant Boi de Llobregat, Barcelona Španjolska
What you need to know before you take Rasagiline Mylan 3.
Što morate znati prije nego počnete uzimati Rasagiline Mylan 3.
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).
Last Observation Carried Forward; posljednje provedeno zapažanje preneseno dalje) je bila statistički značajna (UPDRS, dijelovi I-III: za razagilin 1 mg u usporedbi s placebom -4,2, 95% CI [-5,7, -2,7]; p< 0,0001; za razagilin 2 mg u usporedbi s placebom -3,6, 95% CI [-5,0, -2,1]; p< 0,0001, UPDRS motorička, dio II: za razagilin 1 mg u usporedbi s placebom 2,7, 95% CI [-3,87, -1,55], p< 0,0001; za razagilin 2 mg u usporedbi s placebom -1,68, 95% CI [-2,85, -0,51], p=0,0050).
- The other ingredients are microcrystalline cellulose, tartric acid, maize starch, pregelatinized maize starch, talc, stearic acid.
Drugi sastojci su mikrokristalična celuloza, tartaratna kiselina, kukuruzni škrob, prethodno geliran kukuruzni škrob, talk, stearatna kiselina.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRVOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET/ DATUM OBNOVE ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
For rasagiline no clinical data on exposed pregnancies is available.
Nema dostupnih kliničkih podataka o izloženosti razagilinu u trudnoći.
The robustness of the results for the primary efficacy end point, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Pouzdanost rezultata primarnog ishoda djelotvornosti potvrđena je cijelim skupom dodatnih statističkih modela i pokazana je u tri kohorte (populacija planirana za liječenje (engl. intention to treat, (ITT)), prema protokolu i onim bolesnicima koji su dovršili ispitivanje).
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.
Ako započinjete liječenje fluoksetinom ili fluvoksaminom, morate čekati najmanje 14 dana nakon prekida liječenja lijekom Rasagiline Mylan.
Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline.
Svaka tableta sadrži razagilintartarat u količini koja odgovara 1 mg razagilina.
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.
Ispitivanja in vitro su pokazala da razagilin u koncentraciji od 1 µg/ml (istovjetno razini koja je 160 puta veća od prosječne Cmax ~ 5,9-8,5 ng/ml u bolesnika s Parkinsonovom bolešću nakon višekratnog doziranja 1 mg razagilina) nije inhibirao izoenzime citokroma P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2El, CYP3A4 i CYP4A.
Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Predoziranje: Simptomi prijavljeni nakon predoziranja razagilinom u dozama u rasponu od 3 mg do 100 mg uključivali su disforiju, hipomaniju, hipertenzivnu krizu i serotoninski sindrom.
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 istodobnu primjenu razagilina sa selektivnim inhibitorima ponovne pohrane serotonina (engl. selective serotonin reuptake inhibitors (SSRI))/selektivnim inhibitorima ponovne pohrane serotonina i noradrenalina (engl. selective serotonin norepinephrine reuptake inhibitors (SNRI)) u kliničkim ispitivanjima, vidjeti dio 4.8.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
U bolesnika s Parkinsonovom bolešću koji se kronično liječe levodopom kao dodatnom terapijom, nije bilo klinički značajnog učinka liječenja levodopom na klirens razagilina.
If you are starting treatment with Rasagiline Mylan, you should wait at least 5 weeks after stopping fluoxetine treatment.
Ako započinjete liječenje lijekom Rasagiline Mylan, morate čekati najmanje 5 tjedana nakon prekida liječenja fluoksetinom.
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.
Bolesnici i skrbnici moraju biti upoznati sa bihevioralnim simptomima poremećaja kontrole impulsa koji su bili primjećeni kod bolesnika liječenih razagilinom, uključujući slučajeve kompulzija, opsesivnih misli, patološkog kockanja, povećanog libida, hiperseksualnosti, impulzivnog ponašanja i kompulzivnog trošenja ili kupovanja.
In the post-marketing period, cases of serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants/SNRI concomitantly with rasagiline.
U postmarketinškom razdoblju su prijavljeni slučajevi serotoninskog sindroma povezanog s agitacijom, konfuzijom, rigidnošću, pireksijom i mioklonusom u bolesnika liječenih antidepresivima/SNRI-em istodobno s razagilinom.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Istodobna primjena razagilina i entakapona povećava oralni klirens razagilina za 28%.
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 smije primjenjivati zajedno s drugim MAO inhibitorima (uključujući lijekove i prirodne preparate bez recepta npr. gospinu travu) jer je moguć rizik od neselektivne MAO inhibicije, koja može dovesti do hipertenzivnih kriza (vidjeti dio 4.3).
Because AUC is not substantially affected, rasagiline can be administered with or without food.
Budući da se AUC bitno ne mijenja, razagilin se može primijeniti s hranom ili bez nje.
• heart attack (myocardial infarction)
• srčani udar (infarkt miokarda)
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.
U dvostruko slijepim placebo kontroliranim ispitivanjima 529 bolesnika bilo je liječeno razagilinom 1 mg/dan kroz 212 bolesničkih godina, a 539 bolesnika je primalo placebo kroz 213 bolesničkih godina.
In post-marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
U postmarketinškom iskustvu ovi su simptomi također opaženi u bolesnika s Parkinsonovom bolešću liječenih razagilinom.
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.
Bijele do bjelkaste, duguljaste (približne veličine 11,5 mm x 6 mm) bikonveksne tablete s utisnutom oznakom «R9SE» na jednoj strani i «1» na drugoj strani.
Therefore, in view of the MAO inhibitory activity of rasagiline, the concomitant administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Stoga se, s obzirom na MAO inhibitornu aktivnost razagilina, ne preporučuje istodobna primjena razagilina i dekstrometorfana (vidjeti dio 4.4).