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).
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 placebom2,7, 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).
There is no relevant use of Rasagiline ratiopharm in the paediatric population in the indication Parkinson's disease.
Nema relevantne primjene lijeka Razagilin ratiopharm u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
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).
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).
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.
Razagilin ratiopharm je indiciran u odraslih za liječenje idiopatske Parkinsonove bolesti kao monoterapija (bez levodope) ili kao dodatna terapija (s levodopom) u bolesnika s fluktuacijama prilikom isteka doze.
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline ratiopharm treatment.
Ako započinjete liječenje fluoksetinom ili fluvoksaminom, morate čekati najmanje 14 dana nakon prekida liječenja Razagilin ratiopharmom.
White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Bijele do bjelkaste, okrugle, plosnate tablete kosih rubova s utisnutom oznakom «GIL» i «1» ispod toga na jednoj strani, a bez oznake na drugoj strani.
There are no data from the use of rasagiline in pregnant women.
Nema podataka o primjeni razagilina u trudnica.
In postmarketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
U razdoblju nakon stavljanja lijeka u promet bio je jedan slučaj povišenog krvnog tlaka u bolesnika koji je primijenjivao oftalmički vazokonstriktor tetrahidrozolinklorid tijekom uzimanja razagilina.
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
Posebice obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova - određene antidepresive (selektivne inhibitore ponovne pohrane serotonina, selektivne inhibitore ponovne pohrane serotonina i noradrenalina, tricikličke ili tetracikličke antidepresive) - antibiotik ciprofloksacin koji se primjenjuje protiv infekcija - dekstrometorfan koji se primjenjuje protiv kašlja - simpatomimetike poput onih sadržanih u kapima za oči, nazalnim i oralnim dekongestivima i lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin.
Do not take Rasagiline ratiopharm - If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na razagilin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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.
U ispitivanju postupnog povećavanja doze kod bolesnika na kroničnoj terapiji levodopom liječenih s 10 mg/dan razagilina prijavljene su kardiovaskularne nuspojave (uključujući hipertenziju i posturalnu hipotenziju) koje su se povukle po prestanku liječenja.
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).
Razagilin je kontraindiciran 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).
The safety and efficacy of Rasagiline ratiopharm in children and adolescents have not been established.
Sigurnost i djelotvornost lijeka Razagilin ratiopharm u djece i adolescenata nisu ustanovljene.
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.
For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotoninnorepinephrine 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.
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 su dostupne u blister pakiranjima od 7, 10, 28, 30, 100 i 112 tableta, u perforiranim blisterima s jediničnim dozama u pakiranjima od 10 x 1, 30 x 1 i 100 x 1 tableta ili u bočici koja sadrži 30 tableta.
Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group.
Incidencija melanoma kože u placebom kontroliranim kliničkim ispitivanjima iznosila je 2/380 (0,5 %) u skupini koja je primala razagilin u dozi od 1 mg kao dodatnu terapiju levodopi naspram incidencije od 1/388 (0,3 %) u skupini koja je primala placebo.
If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline ratiopharm do not drive or operate machinery (see section 2).
Ako ste osjetili izrazitu pospanost i/ili epizode iznenadnog nastupa sna prije ili za vrijeme uzimanja lijeka Razagilin ratiopharm, nemojte upravljati vozilima ili strojevima (pogledajte dio 2).
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).
Cases of patients, treated with rasagiline and other dopaminergic medicinal products, falling asleep while engaged in activities of daily living have been reported.
Zabilježeni su slučajevi bolesnika liječenih razagilinom i drugim dopaminergicima koji su zaspali dok su obavljali svakodnevne aktivnosti.
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.
Sljedeći su slučajevi prijavljeni tijekom izloženosti nakon stavljanja lijeka u promet s nepoznatom učestalošću: kompulzije, kompulzivno kupovanje, dermatilomanija, sindrom disregulacije dopamina, poremećaj kontrole impulsa, impulzivno ponašanje, kleptomanija, krađa, opsesivne misli, opsesivnokompulzivni poremećaj, stereotipija, kockanje, patološko kockanje, povećani libido, hiperseksualnost, psihoseksualni poremećaj, neprimjereno seksualno ponašanje.
If you are starting treatment with Rasagiline ratiopharm, you should wait at least 5 weeks after stopping fluoxetine treatment.
Ako započinjete liječenje Razagilin ratiopharmom, morate čekati najmanje 5 tjedana nakon prekida liječenja fluoksetinom.
Agents that affect CYP1A2 activity
Lijekovi koji utječu na aktivnost CYP1A2
Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Razagilin ratiopharm sadrži djelatnu tvar razagilin te se primjenjuje za liječenje Parkinsonove bolesti u odraslih.
No special precautions are required in patients with renal impairment.
Nisu potrebne posebne mjere opreza u bolesnika s oštećenjem bubrega.
What you need to know before you take Rasagiline ratiopharm
Što morate znati prije nego počnete uzimati Razagilin ratiopharm
Aluminium/aluminium perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets.
Aluminij/aluminij perforirani blister s jediničnim dozama u pakiranju od 10 x 1, 30 x 1 i 100 x 1 tableta.
No human data on the effect of rasagiline on fertility are available.
Nema dostupnih podataka o učinku razagilina na plodnost.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
Istodobna primjena razagilina i entakapona povećava oralni klirens razagilina za 28 %.
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.
Nemojte uzimati sljedeće lijekove dok uzimate Razagilin ratiopharm: - inhibitore monoaminooksidaze (MAO) (npr. za liječenje depresije ili Parkinsonove bolesti ili za bilo koju drugu indikaciju), uključujući lijekove i prirodne preparate bez recepta npr. gospinu travu - petidin (snažan lijek protiv boli).
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.
Srednje ukupno dnevno smanjenje u OFF vremenu u entakapon skupini (-0,80 h, 95 % CI [-1,20, -0,41], p< 0,0001) bilo je slično onom opaženom u razagilin 1 mg skupini.
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.
- Drugi sastojci su manitol, koloidni, bezvodni silicijev dioksid, kukuruzni škrob, prethodno geliran kukuruzni škrob, stearatna kiselina, talk.
Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Primjena razagilina je kontraindicirana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
What Rasagiline ratiopharm is and what it is used for
Što je Razagilin ratiopharm i za što se koristi
What Rasagiline ratiopharm looks like and contents of the pack Rasagiline ratiopharm tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Kako Razagilin ratiopharm izgleda i sadržaj pakiranja Razagilin ratiopharm tablete su bijele do bjelkaste, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom „GIL” i „1” ispod toga na jednoj strani, i bez oznake na drugoj strani.
ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Poremećaji kontrole impulsa mogu se pojaviti kod bolesnika liječenih agonistima dopamina i/ili dopaminergičkim lijekovima.
CYP1A2 inducers
Induktori CYP1A2
The recommended dose of Rasagiline ratiopharm is 1 tablet of 1 mg taken by mouth once daily.
Preporučena doza Razagilin ratiopharma je 1 tableta od 1 mg uzeta na usta jedanput dnevno.
Cerebrovascular accident
Cerebrovaskularni inzult
If you stop taking Rasagiline ratiopharm Do not stop taking Rasagiline ratiopharm without first talking to your doctor.
Nemojte prestati uzimati Razagilin ratiopharm prije razgovora sa svojim liječnikom.
Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Razagilin može uzrokovati dnevnu omamljenost, somnolenciju te povremeno, posebice ako se primjenjuje s drugim dopaminergičkim lijekovima, padanje u san tijekom dnevnih aktivnosti.
The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
Vezanje za proteine plazme nakon pojedinačne oralne doze 14C-obilježenog razagilina je približno 60 do 70 %.
Dystonia, Carpal tunnel syndrome, Balance disorder
Diskinezija Distonija, Sindrom karpalnog tunela,
Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep
Serotoninski sindrom*, Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna*
In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
U ispitivanju III srednja razlika u usporedbi s placebom je iznosila 0,94 h, 95 % CI [-1,36, -0,51], p< 0,0001.
Other cytochrome P450 isoenzymes
Drugi izoenzimi citokroma P450
Bottles
Bočice
Common (may affect up to 1 in 10 people)
Često (mogu se javiti u 1 na 10 osoba)
In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain as back and neck pain, and arthralgia in both regimens.
U kliničkim ispitivanjima Parkinsonove bolesti nuspojave koje su bolesnici najčešće prijavljivali bile su: glavobolja, depresija, vrtoglavica i gripa (influenca i rinitis) kod monoterapije; diskinezija, ortostatska hipotenzija, pad, bol u abdomenu, mučnina i povraćanje te suha usta kod dodatne terapije uz levodopu; mišićno-koštana bol kao bol u leđima i vratu te artralgija u oba terapijska režima.
Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with Rasagiline ratiopharm may influence your ability to do so. Rasagiline ratiopharm can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Upitajte svog liječnika za savjet prije upravljanja vozilima i rada sa strojevima jer Parkinsonova bolest sama po sebi, kao i liječenje lijekom Razagilin ratiopharm, može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline.
U razdoblju nakon stavljanja lijeka u promet prijavljeni su po život opasni slučajevi serotoninskog sindroma povezanog s agitacijom, konfuzijom, rigidnošću, pireksijom i mioklonusom u bolesnika liječenih antidepresivima, meperidinom, tramadolom, metadonom ili propoksifenom istodobno s razagilinom.
What Rasagiline ratiopharm contains - The active substance is rasagiline.
Što Razagilin ratiopharm sadrži - Djelatna tvar je razagilin.
CYP1A2 inhibitors
Inhibitori CYP1A2
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BOČICU
In blinded placebo-controlled studies (monotherapy and adjunct) severe hypertension was not reported in any subjects in the rasagiline arm.
U slijepim placebom kontroliranim ispitivanjima (monoterapija i dodatna terapija) teška hipertenzija nije zabilježena ni u jednog ispitanika u skupini koja je primala razagilin.
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.
U ispitivanju II, srednja razlika u broju sati provedenih u „OFF“ stanju u usporedbi s placebom je iznosila -0,78 h, 95 % CI [-1,18, -0,39], p=0,0001.
Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.
Stoga se ne preporučuje primjena lijeka Razagilin ratiopharm u djece i adolescenata mlađih od 18 godina.
In patients taking Rasagiline ratiopharm and/or other medicines 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.
Kod bolesnika koji uzimaju Razagilin ratiopharm i/ili druge lijekove koji se koriste za liječenje Parkinsonove bolesti bila su opažena ponašanja kao što su kompulzije, opsesivne misli, ovisnost o kockanju, prekomjerno trošenje, impulzivno ponašanje i nenormalno visok seksualni nagon ili povećanje misli i osjećanja povezanih sa seksualnošću.
In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
U osoba s blagim oštećenjem jetre, AUC se povećava za 80 %, a Cmax za 38 %.
- Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
(ortostatska hipotenzija) - smanjen apetit - zatvor - suha usta - mučnina i povraćanje - vjetrovi - abnormalni rezultati krvnih testova (leukopenija) - bol u zglobovima (artralgija) - mišićno-koštana bol - upala zglobova (artritis) - utrnulost i slabost mišića ruke (sindrom karpalnog tunela) - smanjenje tjelesne težine - abnormalni snovi - poteškoće u mišićnoj koordinaciji (poremećaj ravnoteže) - depresija - omaglica (vrtoglavica) - produljene mišićne kontrakcije (distonija) - curenje nosa (rinitis) - nadražaj kože (dermatitis) - osip - crvenilo očiju (konjunktivitis) - hitan nagon za mokrenjem
Levodopa and other Parkinson's disease medicinal products In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Kod bolesnika s Parkinsonovom bolešću koji primaju kroničnu terapiju levodopom i razagilin kao dodatnu terapiju nije bilo klinički značajnog učinka terapije levodopom na klirens razagilina.
You must wait at least 14 days after stopping Rasagiline ratiopharm treatment and starting treatment with MAO inhibitors or pethidine.
Morate čekati najmanje 14 dana nakon prestanka liječenja Razagilin ratiopharmom i početka liječenja MAO inhibitorima ili petidinom.
Orthostatic hypotension*
Ortostatska hipotenzija*
Other medicines and Rasagiline ratiopharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
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
Što je Razagilin ratiopharm i za što se koristi Što morate znati prije nego počnete uzimati Razagilin ratiopharm
There is no relevant use of Rasagiline ratiopharm in children and adolescents.
Nema relevantne primjene lijeka Razagilin ratiopharm u djece i adolescenata.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/001-010
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/977/001-010
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate).
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
You may need urgent medical advice or treatment: - If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
Ako razvijete neuobičajena ponašanja poput kompulzija, opsesivnih misli, ovisnosti o kockanju, prekomjerno kupovanje ili trošenje novca, impulzivno ponašanje ili abnormalno jaki seksualni nagon ili učestale misli o seksu (poremećaji kontrole impulsa) (pogledajte dio 2).
Half of the reported ICD cases were assessed as serious.
Polovica prijavljenih slučajeva poremećaja kontrole impulsa ocijenjena je ozbiljnima.
Uncommon (may affect up to 1 in 100 people)
Manje često (mogu se javiti u 1 na 100 osoba)
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre razagilin je potrebno ukinuti (vidjeti dio 5.2).
Each tablet contains 1 mg rasagiline (as mesilate).
Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies, in patients receiving 1 mg/day rasagiline.
Niže navedeni tablični popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima, kod bolesnika koji su primali 1 mg/dan razagilina.
INFORMATION IN BRAILLE Rasagiline ratiopharm
16. PODACI NA BRAILLEOVOM PISMU Razagilin ratiopharm
If you forget to take Rasagiline ratiopharm
Ako ste zaboravili uzeti Razagilin ratiopharm
A similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline.
U razdoblju nakon stavljanja lijeka u promet prijavljen je sličan obrazac prekomjerne dnevne pospanosti s razagilinom.
Do not store above 30oC.
Ne čuvati na temperaturi iznad 30oC.
- Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
- moždani udar (cerebrovaskularni događaj) - srčani udar (infarkt miokarda)
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2).
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre, razagilin je potrebno ukinuti (vidjeti dio 4.4 i 5.2).
Impulse control disorders*
Poremećaji kontrole impulsa*
Rasagiline ratiopharm 1 mg tablets rasagiline
Razagilin ratiopharm 1 mg tablete razagilin
Rasagiline ratiopharm
Razagilin ratiopharm
Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes
Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU NALJEPNICA ZA BOČICU
MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/007
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/977/007