natgillin/translations-raw huggingface dataset:
If increased somnolence or new episodes of falling asleep during activities of daily living (e.g. watching television, passenger in a car, etc.) are experienced at any time during treatment, the patients should not drive or participate in potentially dangerous activities.
Če bolniki kadar koli med zdravljenjem doživijo povečano število napadov somnolence ali nove epizode spanca med dejavnostmi vsakodnevnega življenja (npr. med gledanjem televizije, vožnjo kot sopotnik v avtomobilu itd.), naj ne vozijo ali sodelujejo v morebitno nevarnih dejavnostih.
The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
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.
In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on the ability to drive and use machines.
Pri bolnikih, ki so doživeli somnolenco in/ali epizode nenadnega spanca, ima razagilin lahko pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Blisters: 3 years Bottles: 3 years
Plastenka: 3 leta
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.
Učinkovitost razagilina je bila ugotovljena v treh kliničnih študijah: kot monoterapija v študiji I in kot dodatna terapija k levodopi v študijah II in III.
Concomitant use of rasagiline and levodopa
Sočasna uporaba razagilina in levodope
Ex vivo and in vitro experiments demonstrate that rasagiline is neither inhibitor nor inducer of major CYP450 enzymes (see section 4.5).
Poskusi ex vivo ter in vitro kažejo, da razagilin ni niti inhibitor niti induktor glavnih encimov CYP450 (glejte poglavje 4.5).
Symptoms reported following overdose of Rasagiline ratiopharm included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Simptomi, o katerih so poročali po prevelikem odmerjanju zdravila Razagilin ratiopharm, so vključevali rahlo evforično razpoloženje (lahka oblika manije), izredno visok krvni tlak in serotoninski sindrom (glejte poglavje 4).
Concomitant use of rasagiline with other medicinal products
Sočasna uporaba razagilina in drugih zdravil
In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
Pri osebah z zmernimi jetrnimi okvarami, sta AUC in Cmax porasla za 568 % in 83 % (glejte poglavje 4.4).
4.5 Interaction with other medicinal products and other forms of interaction MAO Inhibitors
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Inhibitorji monoaminooksidaze (MAO)
Impulse control disorders (ICDs)
Motnje pri obvladovanju impulzov (Impulse control disorders - ICDs)
After oral administration of 14C-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.
C-označenim razagilinom nastopi izločanje v glavnem preko urina (62,6 %) in sekundarno preko blata (21,8 %), s celotnim izločanjem 84,4 % odmerka v 38 dnevih.
Thus, potent CYP1A2 inhibitors may alter rasagiline plasma levels and should be administered with caution.
Močni inhibitorji CYP1A2 lahko torej spremenijo plazemske ravni razagilina, zaradi česar jih je treba uporabljati previdno.
White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Bela plastenka iz polietilena visoke gostote, z ali brez za otroke varnim pokrovčkom, vsebuje 30 tablet.
The safety and efficacy of Rasagiline ratiopharm in children and adolescents have not been established.
Varnost in učinkovitost zdravila Razagilin ratiopharm pri otrocih in mladostnikih nista bili dokazani.
Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of rasagiline.
Bolniki naj med zdravljenjem ne vozijo, upravljajo strojev ali delajo na višinah, če so med uporabo razagilina že doživeli somnolenco in/ali zaspali brez predhodnega opozorila.
Rasagiline ratiopharm helps to increase and sustain levels of dopamine in the brain.
Zdravilo Razagilin ratiopharm pomaga zvišati in vzdrževati raven dopamina v možganih.
In post-marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
V izkušnjah iz obdobja trženja so prav tako zaznali navedene simptome pri bolnikih s Parkinsonovo boleznijo, ki so bili zdravljeni z razagilinom.
Results of five tyramine challenge studies (in volunteers and Parkinson's disease 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 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 šestmesečne 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.
No special precautions are required in patients with renal impairment.
Pri bolnikih z ledvično okvaro niso potrebni posebni previdnostni ukrepi.
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 % IZ [-5,7; -2,7]; p < 0,0001; za razagilin 2 mg v primerjavi s placebom -3,6; 95 % IZ [-5,0; -2,1]; p < 0,0001; UPDRS motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7; 95 % IZ [-3,87; -1,55]; p < 0,0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95 % IZ [-2,85; -0,51]; p = 0,0050).
Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.
Zato jemanje zdravila Razagilin ratiopharm ni priporočeno za mlajše od 18 let.
Patients being treated with rasagiline and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until they have gained sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely.
Bolnike, ki se zdravijo z razagilinom in so doživeli somnolenco in/ali epizode nenadnega spanca, je treba opozoriti, da se morajo vzdržati vožnje ali izvajanja dejavnosti, pri katerih lahko zaradi zmanjšane budnosti izpostavijo sebe ali druge tveganju resnih poškodb ali smrti (npr. upravljanje strojev), dokler ne dobijo dovolj izkušenj z razagilinom in drugimi dopaminergičnimi zdravili, da lahko presodijo, ali zdravilo na njihovo duševno in/ali motorično delovanje vpliva ali ne.
You should avoid taking Rasagiline ratiopharm if you are pregnant, as the effects of Rasagiline ratiopharm on pregnancy and the unborn child are not known.
Izogibajte se jemanju zdravila Razagilin ratiopharm med nosečnostjo, ker učinki zdravila Razagilin ratiopharm na nosečnost in nerojenega otroka niso znani.
These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes (see section 5.3).
Glede na te rezultate ni verjetno, da bi terapevtske koncentracije razagilina klinično pomembno součinkovale s substrati teh encimov (glejte poglavje 5.3).
There are no data from the use of rasagiline in pregnant women.
Podatkov o uporabi razagilina pri nosečnicah ni.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema levkopenija
The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline ratiopharm) once daily, to be taken with or without levodopa.
Priporočeni odmerek razagilina je 1 mg (ena tableta zdravila Razagilin ratiopharm) enkrat dnevno, ki se jemlje z levodopo ali brez nje.
Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline, or when taking concomitant medications that increase plasma levels of rasagiline (e.g. ciprofloxacin) (see section 4.4).
Bolnike je treba opozoriti o morebitnih dodatnih učinkih pomirjeval, alkohola ali drugih depresorjev centralnega živčnega sistema (npr. benzodiazepini, antipsihotiki, antidepresivi) v kombinaciji z razagilinom ali med sočasnim jemanjem zdravil, ki zvišajo koncentracije razagilina v plazmi (npr. ciprofloksacin) (glejte poglavje 4.4).
A similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline.
O podobnem vzorcu prekomerne dnevne zaspanosti so poročali v obdobju trženja razagilina.
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).
It can be used together with or without Levodopa (another medicine that is used to treat Parkinson's disease).
Lahko ga uporabljamo z levodopo (drugo zdravilo za zdravljenje Parkinsonove bolezni) ali brez nje.
Aluminium/aluminium blister packs of 7, 10, 28, 30, 100 or 112 tablets.
Aluminij/aluminij pretisni omoti po 7, 10, 28, 30, 100 ali 112 tablet.
Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Sočasna uporaba razagilina in ciprofloksacina (inhibitor CYP1A2) je povečala AUC razagilina za 83 %.
Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included hypomania, hypertensive crisis and serotonin syndrome.
Simptomi, ki so jih navajali pri prevelikem odmerku razagilina pri odmerkih od 3 mg do 100 mg, so vključevali hipomanijo, hipertenzivno krizo in serotoninski sindrom.
Rasagiline ratiopharm may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease).
Zdravilo Razagilin ratiopharm lahko povzroči zaspanost in da nenadoma zaspite med vsakodnevnimi dejavnostmi, zlasti če jemljete tudi druga dopaminergična zdravila (ki se uporabljajo za zdravljenje Parkinsonove bolezni).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Datum prve odobritve: 12. januar 2015 Datum zadnjega podaljšanja:
Angina pectoris
Srčne bolezni angina pektoris
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.
Farmakokinetične lastnosti razagilina so bile pri osebah z blago (očistek kreatinina (CLcr) 5080 ml/min) in zmerno (CLcr 30 - 49 ml/min) podobne kot pri zdravih osebah.
What Rasagiline ratiopharm is and what it is used for What you need to know before you take Rasagiline ratiopharm How to take Rasagiline ratiopharm Possible side effects
Kaj je zdravilo Razagilin ratiopharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Razagilin ratiopharm Kako jemati zdravilo Razagilin ratiopharm Možni neželeni učinki
Tyramine/rasagiline interaction
Interakcije tiramin/razagilin
The use of Rasagiline ratiopharm together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Potrebno se je izogibati uporabi zdravila Razagilin ratiopharm skupaj z antidepresivi, ki vsebujejo fluoksetin ali fluvoksamin.
As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi razagilina bolje izogibati.
For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotoninnorepinephrine 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.
Hypertension*
hipertenzija*
Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Razagilin je kontraindiciran pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3).
In postmarketing 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.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/007
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/977/007
Skin carcinoma
kožni rak
Since rasagiline potentiates the effects of levodopa, the adverse reactions of levodopa may be increased and pre-existing dyskinesia exacerbated.
Ker razagilin poveča učinke levodope, se lahko neželeni učinki levodope povečajo in obstoječa diskinezija poslabša.
For further information please refer to section driving and using machines.
Za več informacij glejte poglavje Vpliv na sposobnost upravljanja vozil in strojev.
Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Zdravilo Razagilin ratiopharm vsebuje učinkovino razagilin in se uporablja pri zdravljenju Parkinsonove bolezni pri odraslih.
Rasagiline ratiopharm is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Zdravilo Razagilin ratiopharm je indicirano pri odraslih za zdravljenje idiopatske Parkinsonove bolezni kot monoterapija (brez levodope) ali kot dodatna terapija (z levodopo) pri bolnikih z nihanji končnih odmerkov.
Take the Rasagiline ratiopharm carton/ blister or bottle with you to show the doctor or pharmacist.
S seboj vzemite škatlo/pretisni omot ali plastenko zdravila Razagilin ratiopharm, da jo boste lahko pokazali zdravniku ali farmacevtu.
Especially tell your doctor if you are taking any of the following medicines: - 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
Predvsem obvestite zdravnika, če jemljete katerega od naslednjih zdravil: - določene antidepresive (selektivni inhibitorji ponovnega privzema serotonina, selektivni inhibitorji ponovnega privzema serotonina-norepinefrina, triciklični ali tetraciklični antidepresivi), - antibiotik ciprofloksacin, ki se uporablja proti infekcijam, - zdravilo za pomirjanje kašlja dekstrometorfan, - simpatikomimetike, kot so tisti, ki so prisotni v kapljicah za oči, nosnih ali peroralnih dekongestivih in zdravila proti prehladu, ki vsebujejo efedrin ali psevdoefedrin.
Agents that affect CYP1A2 activity
Učinkovine, ki vplivajo na aktivnost CYP1A2
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Sočasna uporaba razagilina in entakapona poveča peroralni očistek razagilina za 28 %.
This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline ratiopharm.
To se lahko okrepi, če med uporabo zdravila Razagilin ratiopharm jemljete druga zdravila za zdravljenje simptomov Parkinsonove bolezni ali če jemljete zdravila, ki lahko povzročijo zaspanost, ali če pijete alkohol.
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.
Študije in vitro 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.
Rasagiline selectively inhibits MAO-B and is not associated with increased tyramine sensitivity at the indicated dose (1 mg/day).
Razagilin selektivno zavira MAO-B in ob indiciranem odmerku (1 mg/dan) ni povezan s povečano občutljivostjo na tiramin.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets, in perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets or in a bottle containing 30 tablets.
Tablete so na voljo v pretisnih omotih v škatli po 7, 10, 28, 30, 100 in 112 tablet, perforiranih pretisnih omotih za enkratni odmerek po 10 x 1, 30 x 1 in 100 x 1 tableto ali v plastenki s 30 tabletami.
White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Bele do belkaste, okrogle, ploščate, prirezane tablete, z vtisnjenim »GIL« in »1« spodaj na eni strani in brez odtisov na drugi strani.
Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Razagilin lahko povzroči dnevno zaspanost, somnolenco, in občasno, zlasti če se uporablja z drugimi dopaminergičnimi zdravili - nastop spanca med dejavnostmi vsakdanjega življenja.
In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular adverse reactions (including hypertension and postural hypotension) which resolved following treatment discontinuation.
V študiji višanja odmerkov pri bolnikih na kronični terapiji z levodopo, ki so prejemali 10 mg/dan razagilina, so poročali o srčno žilnih neželenih učinkih (vključno s hipertenzijo in posturalno hipotenzijo), ki pa so minili po prekinitvi zdravljenja.
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 (see section 4.5).
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 (glejte poglavje 4.5).
In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Pri osebah z blago jetrno okvaro AUC in Cmax porasteta za 80 % oz. 38 %.
Do not take the following medicines while taking Rasagiline ratiopharm: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease, or used for any other indication), including medicinal and natural products without prescription e.g.
Medtem ko jemljete zdravilo Razagilin ratiopharm, ne jemljite naslednjih zdravil: - zaviralcev monoaminooksidaze (MAO) (npr. za zdravljenje depresije ali Parkinsonove bolezni ali pa za katero koli drugo indikacijo), vključno z zdravili in naravnimi pripravki brez recepta kot je npr. šentjanževka.
Additional cases of malignant melanoma were reported during post-marketing period.
V obdobju trženja so poročali o dodatnih primerih malignega melanoma.
The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
V izkušnjah iz obdobja trženja so poročali o naslednjih učinkih z neznano pogostnostjo: kompulzije, kompulzivno nakupovanje, dermatilomanija, sindrom motene regulacije dopamina, motnja obvladovanja impulzov, impulzivno vedenje, kleptomanija, kraja, obsesivne misli, obsesivnokompulzivna motnja, stereotipnost, hazardiranje, patološko hazardiranje, povečan libido, hiperseksualnost, psihoseksualna motnja in neprimerno spolno vedenje.
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.
- Druge sestavine so manitol, brezvodni koloidni silicijev dioksid, koruzni škrob, predgelirani koruzni škrob, stearinska kislina in smukec.
Aluminium/aluminium perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets.
Aluminij/aluminij perforirani pretisni omoti za enkratni odmerek po 10 x 1, 30 x 1 in 100 x 1 tableta.
If you stop taking Rasagiline ratiopharm Do not stop taking Rasagiline ratiopharm without first talking to your doctor.
Ne prenehajte jemati zdravila Razagilin ratiopharm, ne da bi se prej pogovorili z zdravnikom.
Non-clinical data indicate that rasagiline has no effect on fertility.
Predklinični podatki kažejo, da razagilin ne vpliva na plodnost.
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.
Rasagiline is contraindicated 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).
Uporaba razagilina skupaj z drugimi inhibitorji MAO (vključno z zdravili in naravnimi pripravki brez recepta kot je npr. šentjanževka) je kontraindicirana, ker obstaja tveganje, da bi neselektivna inhibicija monoaminooksidaze (MAO) lahko vodi do hipertenzivnih kriz (glejte poglavje 4.3).
CYP1A2 inducers
Induktorji CYP1A2
Other cytochrome P450 isoenzymes
Drugi izoencimi citokroma P450