natgillin/translations-raw huggingface dataset:
In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
Ispitivanja metabolizma in vitro su uputila na to da je citokrom P450 1A2 (CYP1A2) glavni enzim odgovoran za metabolizam razagilina.
It is not known whether rasagiline is excreted in human milk.
Nije poznato izlučuje li se razagilin u majčino mlijeko.
• irritation of the skin (dermatitis)
• nadražaj kože (dermatitis)
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors including another selective MAO-B inhibitor.
Prijavljene su ozbiljne nuspojave pri istodobnoj primjeni petidina i MAO inhibitora, uključujući i drugi selektivni MAO-B inhibitor.
There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Kod bolesnika koji su pušači postoji rizik od smanjenja razina razagilina u plazmi zbog indukcije metabolizirajućeg enzima CYP1A2.
Common: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%) Nervous system disorders
Često: depresija (5,4% naspram 2%), halucinacije (1,3% naspram 0,7%) Poremećaji živčanog sustava
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.
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).
U ovom ispitivanju je primarna mjera djelotvornosti bila promjena od početne vrijednosti u ukupnom zbroju ujedinjene ljestvice za ocjenu Parkinsonove bolesti (engl.
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).
Niže navedeni popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima u bolesnika koji su primali 1 mg/dan razagilina (razagilin skupina n=380, placebo skupina n=388).
Common: dermatitis (2.0% vs. 0%)
Često: dermatitis (2,0% naspram 0%)
Renal impairment No change in dose is required for renal impairment.
Kod oštećenja bubrega nije potrebna promjena doze.
What Rasagiline Mylan looks like and contents of the pack Rasagiline tablets are presented as white to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE' on one side and ‘1' on the other side.
Kako Rasagiline Mylan izgleda i sadržaj pakiranja Rasagiline tablete su 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.
Very common: dyskinesia (10.5% vs. 6.2%)
Vrlo često: diskinezija (10,5% naspram 6,2%)
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and reproduction toxicity.
Neklinički podaci na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i reproduktivne toksičnosti ne ukazuju na poseban rizik za ljude.
Rasagiline Mylan may be taken with or without food.
Rasagiline Mylan se može uzeti sa ili bez hrane.
• stroke (cerebrovascular accident)
• moždani udar (cerebrovaskularni događaj)
Hepatic impairment: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Oštećenje jetre: U osoba s blagim oštećenjem jetre, AUC se povećava za 80%, a Cmax za 38%.
What you need to know before you take Rasagiline Mylan
Što morate znati prije nego počnete uzimati Rasagiline Mylan
In patients taking Rasagiline Mylan and/or other medications used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Kod bolesnika koji uzimaju Rasagiline Mylan 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.
• musculoskeletal pain
• mišićno-koštana bol
Mylan, Lda.
Portugal Mylan Lda.
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.
There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Prijavljene su interakcije lijekova pri istodobnoj primjeni dekstrometorfana i neselektivnih MAO inhibitora.
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).
Niže navedeni popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima, kod bolesnika koji su primali 1 mg/dan razagilina (razagilin skupina n=149, placebo skupina n=151).
Conjugation of rasagiline and its metabolites was also found to be a major elimination pathway to yield glucuronides.
Također je otkriveno da je glavni eliminacijski put konjugacija razagilina i njegovih metabolita do stvaranja glukuronida.
597 678 01 Blansko Czech Republic
Synthon s.r.o Brněnská 32/čp. 597 678 01 Blansko Češka Republika
In vitro experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism.
Pokusi in vitro indiciraju na to da su oba puta metabolizma razagilina ovisna o sustavu citokroma P450, s CYP1A2 kao glavnim izoenzimom uključenim u metabolizam razagilina.
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.
With MAO inhibitors there have been reports of medicinal product interactions with the concomitant use of sympathomimetic medicinal products.
Kod MAO inhibitora su prijavljene interakcije lijekova pri istodobnoj primjeni simpatomimetskih lijekova.
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
Posavjetujte se s liječnikom prije uzimanja bilo kojeg od sljedećih lijekova zajedno s lijekom Rasagiline Mylan: određenih antidepresiva (selektivnih inhibitora ponovne pohrane serotonina, selektivnih inhibitora ponovne pohrane serotonina i noradrenalina, tricikličkih ili tetracikličkih antidepresiva) antibiotika ciprofloksacina koji se upotrebljava protiv infekcija dekstrometorfana koji se primjenjuje protiv kašlja simpatomimetika poput onih sadržanih u kapima za oči, nazalnim i oralnim dekongestivima i lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin.
You must wait at least 14 days after stopping Rasagiline Mylan treatment and starting treatment with MAO inhibitors or pethidine.
Morate čekati najmanje 14 dana nakon prestanka liječenja lijekom Rasagiline Mylan i početka liječenja MAO inhibitorima ili petidinom.
Severe hepatic impairment.
Teško oštećenje jetre.
If you forget to take Rasagiline Mylan
Ako ste zaboravili uzeti Rasagiline Mylan
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment.
Oprez je nužan na početku liječenja razagilinom u bolesnika s blagim oštećenjem jetre.
In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively.
U zagradama je navedena incidencija nuspojava (% bolesnika) kod razagilina naspram placebu.
Synthon Hispania S.L., C/ Castelló no1, Pol. Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Spain
Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Španjolska
Uncommon: decreased appetite (0.7% vs. 0%) Psychiatric disorders
Manje često: smanjen apetit (0,7% naspram 0%) Psihijatrijski poremećaji
Common: dystonia (2.4% vs. 0.8%), carpal tunnel syndrome (1.3% vs. 0%), balance disorder (1.6% vs. 0.3%)
Često: distonija (2,4% naspram 0,8%), sindrom karpalnog tunela (1,3% naspram 0%), poremećaj ravnoteže (1,6% naspram 0,3%)
• abnormal movements (dyskinesia)
• abnormalni pokreti (diskinezija)
Rasagiline pharmacokinetics are linear with dose over the range of 0.5-2 mg. Its terminal half-life is 0.6-2 hours.
Farmakokinetika razagilina je linearna s dozama u rasponu od 0,5-2 mg.
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.
U ispitivanju III, bolesnici su metodom slučajnog odabira bili raspodijeljeni da prime placebo (159 bolesnika), razagilin 0,5 mg/dan (164 bolesnika) ili razagilin 1 mg/dan (149 bolesnika) i bili su liječeni 26 tjedana.
Rasagiline Mylan 1 mg tablets rasagiline
Rasagiline Mylan 1 mg tablete razagilin
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended (see section 4.5).
Ne preporučuje se istodobna primjena razagilina i dekstrometorfana ili simpatomimetika poput onih sadržanih u nazalnim i oralnim dekongestivima ili lijekova za prehladu koji sadrže efedrin ili pseudoefedrin (vidjeti dio 4.5).
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
Istodobnu primjenu razagilina i fluoksetina ili fluvoksamina potrebno je izbjegavati (vidjeti dio 4.5).
Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5).
Istodobno liječenje drugim inhibitorima monoaminooksidaze (MAO) (uključujući lijekove bez recepta i prirodne preparate npr. gospinu travu) ili petidinom (vidjeti dio 4.5).
Common: hallucinations (2.9% vs. 2.1%), abnormal dreams (2.1% vs. 0.8%) Uncommon: confusion (0.8% vs. 0.5%)
Često: halucinacije (2,9% naspram 2,1%), abnormalni snovi (2,1% naspram 0,8%) Manje često: konfuzija (0,8% naspram 0,5%) Poremećaji živčanog sustava
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.
I su 404 bolesnika metodom slučajnog odabira bili raspodijeljeni da prime placebo (138 bolesnika), razagilin 1 mg/dan (134 bolesnika) ili razagilin 2 mg/dan (132 bolesnika) i bili su liječeni 26 tjedana, nije bilo aktivnog komparatora.
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Nužno je izbjegavati istodobnu primjenu razagilina i fluoksetina ili fluvoksamina (vidjeti dio 4.4).
At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline.
Mora proći najmanje 5 tjedana između prestanka primjene fluoksetina i početka liječenja razagilinom.
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Mora proći najmanje 14 dana između prestanka primjene razagilina i početka liječenja fluoksetinom ili fluvoksaminom.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister packs containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets.
Tablete su dostupne u blister pakiranjima od 7, 10, 28, 30, 100 i 112 tableta ili perforiranim blisterima, djeljivima na jedinične doze koji sadrži od 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 ili 112 x 1 tableta.
Uncommon: cerebrovascular accident (0.5% vs. 0.3%) Cardiac disorders
Manje često: cerebrovaskularni događaj (0,5% naspram 0,3%) Srčani poremećaji
Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Poznato je da se ozbiljne nuspojave javljaju uz istodobnu primjenu SSRI-a, SNRI-a, tricikličkih/tetracikličkih antidepresiva i MAO inhibitora.
The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
Istodobna primjena razagilina i petidina je kontraindicirana (vidjeti dio 4.3).
Uncommon: angina pectoris (0.5% vs. 0%)
Manje često: angina pektoris (0,5% naspram 0%) Krvožilni poremećaji
How to store Rasagiline Mylan 6.
Kako čuvati Rasagiline Mylan 6.
Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Prijavljene su ozbiljne nuspojave kod istodobne primjene SSRI-a, SNRI-a, tricikličkih/tetracikličkih antidepresiva i MAO inhibitora.
• prolonged muscle contractions (dystonia)
• produljene mišićne kontrakcije (distonija)
• general feeling of being unwell (malaise)
• opće loše osjećanje (malaksalost)
Common: allergy (1.3% vs. 0.7%)
Često: alergija (1,3% naspram 0,7%)
Common: influenza (4.7% vs. 0.7%)
Često: influenca (4,7% naspram 0,7%)
Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: skin carcinoma (1.3% vs. 0.7%) Blood and lymphatic system disorders Common: leucopenia (1.3% vs. 0%)
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Često: karcinom kože (1,3% naspram 0,7%) Poremećaji krvi i limfnog sustava
• fall
• pad
Do not take the following medicines while taking Rasagaline Mylan: - monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Nemojte uzimati sljedeće lijekove dok uzimate Rasagiline Mylan: 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).
Common: conjunctivitis (2.7% vs. 0.7%)
Često: konjunktivitis (2,7% naspram 0,7%)
• flatulence
• nadutost
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 medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Stoga se, s obzirom na MAO inhibitornu aktivnost razagilina, ne preporučuje istodobna primjena razagilina i simpatomimetika poput onih sadržanih u nazalnim i oralnim dekongestivima ili lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin (vidjeti dio 4.4).
At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
Mora proći najmanje 14 dana između prestanka primjene razagilina i početka liječenja MAO inhibitorima ili petidinom.
Common: orthostatic hypotension (3.9% vs. 0.8%) Gastrointestinal disorders
Često: ortostatska hipotenzija (3,9% naspram 0,8%)
Mylan S.p.A Tel: + 39 02 612 46921
Tel: +39 02 612 46921
• Rare (may affect up to 1 in 1,000 people)
• Rijetko (mogu se javiti u 1 na 1000 osoba)
Česká republika Mylan Pharmaceuticals s.r.o.
Mylan Pharmaceuticals S.L.
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Kontraindicirana je primjena razagilina u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
How to take Rasagiline Mylan
Kako uzimati Rasagiline Mylan
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre razagilin je potrebno ukinuti (vidjeti dio 5.2).
Rasagiline Mylan 1 mg tablets
NAZIV GOTOVOG LIJEKA Rasagiline Mylan 1 mg tablete
• Very common (may affect more than 1 in 10 people)
• Vrlo često (mogu se javiti u više od 1 na 10 osoba)
• Very rare (may affect up to 1 in 10,000 people)
• Vrlo rijetko (mogu se javiti u 1 na 10 000 osoba)
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4).
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre, razagilin je potrebno ukinuti (vidjeti dio 4.4).
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: skin melanoma (0.5% vs. 0.3%)
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Manje često: melanom kože (0,5% naspram 0,3%) Poremećaji metabolizma i prehrane
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.
I i kao dodatna terapija levodopi u ispitivanjima II i III.
General disorders and administration site conditions Common: fever (2.7% vs. 1.3%), malaise (2% vs. 0%)
Opći poremećaji i reakcije na mjestu primjene Često: vrućica (2,7% naspram 1,3%), slabost (2% naspram. 0%)
Musculoskeletal and connective tissue disorders Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%)
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: atralgija (2,4% naspram 2,1%), bol u vratu (1,3% naspram 0,5%) Pretrage
Rasagiline may be taken with or without food.
Razagilin se može uzimati s hranom ili bez nje.
Warnings and precautions Talk to your doctor before taking Rasagiline Mylan.
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Rasagiline Mylan. ako imate blage do umjerene probleme s jetrom ako imate bilo kakve sumnjive promjene na koži.
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. Rasagiline produced statistically significant benefit compared to placebo.
Sekundarne mjere djelotvornosti su uključivale opće procjene istraživača o poboljšanju, zbrojeve podljestvice aktivnosti svakodnevnog življenja (engl.
• bloodshot eyes (conjunctivitis)
• crvenilo očiju (konjunktivitis)
Common: decreased weight (4.5% vs. 1.5%) Injury, poisoning and procedural complications Common: fall (4.7% vs. 3.4%)
Ozljede, trovanja i proceduralne komplikacije Često: pad (4,7% naspram 3,4%)
Rasagiline use in patients with moderate hepatic impairment should be avoided.
Primjenu razagilina u bolesnika s umjerenim oštećenjem jetre nužno je izbjegavati.
In post-marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
Ovi simptomi su opaženi i tijekom razdoblja nakon stavljanja lijeka u promet u bolesnika s Parkinsonovom bolešću liječenih razagilinom.
How to store Rasagiline Mylan
Kako čuvati Rasagiline Mylan
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.
COMT), entakapon, 200 mg uzet zajedno s redovitim dozama levodope (LD)/inhibitora dekarboksilaze (227 bolesnika), i bili su liječeni 18 tjedana.
Common: decreased appetite (2.4% vs. 0.8%)
Često: smanjen apetit (2,4% naspram 0,8%) Psihijatrijski poremećaji
Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), dry mouth (3.4% vs. 1.8%)
2,1%), mučnina i povraćanje (8,4% naspram 6,2%), suha usta (3,4% naspram 1,8%) Poremećaji kože i potkožnog tkiva Često: osip (1,1% naspram 0,3%)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Kod bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima mogu se pojaviti patološko kockanje, povećan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje.
Cellulose, microcrystalline Tartaric acid
6.1 Popis pomoćnih tvari celuloza, mikrokristalična tartaratna kiselina kukuruzni škrob škrob, prethodno geliran kukuruzni talk stearatna kiselina
Musculoskeletal and connective tissue disorders Common: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs.0.7%) Renal and urinary disorders
Često: mišićno-koštana bol (6,7% naspram 2,6%), bol u vratu (2,7% naspram 0%), artritis (1,3%
Uncommon: myocardial infarction (0.7% vs. 0%) Respiratory, thoracic and mediastinal disorders Common: rhinitis (3.4% vs. 0.7%)
Često: angina pektoris (1,3% naspram 0%); Manje često: infarkt miokarda (0,7% naspram 0%) Poremećaji dišnog sustava, prsišta i sredoprsja
4.7 Effects on ability to drive and use machines
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedene studije utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
Very common: headache (14.1% vs. 11.9%) Uncommon: cerebrovascular accident (0.7% vs. 0%)
Vrlo često: glavobolja (14,1% naspram 11,9%)
Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712
Česká republika Mylan Pharmaceuticals s.r.o. Tel: + 420 222 004 400
• Common (may affect up to 1 in 10 people)
• Često (mogu se javiti u 1 na 10 osoba)
Caution should be exercised when rasagiline is administered to a breast-feeding mother.
Nužan je oprez kod primjene razagilina u dojilja.
Tel: + 386 1 236 31 85
GSP Proizvodi d.o.o. Tel: +386 1 236 31 85
C-labelled rasagiline is approximately 60 to
Vezanje za proteine plazme nakon pojedinačne oralne doze 14C-obilježenog razagilina je približno 60 do
Common: flatulence (1.3% vs.0%)
Često: leukopenija (1,3% naspram 0%)
• headedness (orthostatic hypotension)
(ortostatska hipotenzija)
How to take Rasagiline Mylan 4.
Kako uzimati Rasagiline Mylan 4. Moguće nuspojave
• Uncommon (may affect up to 1 in 100 people)
• Manje često (mogu se javiti u 1 na 100 osoba)
OTHER
DODATAK
Rasagiline Mylan
Što Rasagiline Mylan sadrži
• blistering rash (vesiculobullous rash)
• upala zglobova (artritis)
Common: rash (1.1% vs. 0.3%)
Često: rinitis (3,4% naspram 0,7%)
Common: urinary urgency (1.3% vs. 0.7%).
Poremećaji bubrega i mokraćnog sustava Često: urgencija mokrenja (1,3% naspram 0,7%).
Deutschland Mylan dura GmbH
V.J. Salomone Pharma Ltd
Similar reports of ICDs have also been received post-marketing with rasagiline.
U postmarketinškom razdoblju su zaprimljene slične prijave poremećaja kontrole impulsa sa razagilinom.
Synthon s.r.o Brněnská 32/čp.
Synthon s.r.o, Brněnská 32/čp. 597 678 01 Blansko Češka Republika
Salomone Pharma Ltd Tel: + 356 21 22 01 74
Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599
Investigations
U ispitivanju
• joint inflammation (arthritis)
• bol u zglobovima (artralgija)
Date of first authorisation: April 2015
Datum prvog odobrenja: Travanj 2015
• At the request of the European Medicines Agency;
• Na zahtjev Europske agencije za lijekove
Turn over to continue…
Okrenuti za nastavak…
Always take Ristempa exactly as your doctor has told you.
Uvijek primijenite Ristempu točno onako kako Vam je rekao liječnik.
If you use more Ristempa than you should
Ako primijenite više Ristempe nego što biste trebali
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made
Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1. i 5.2, međutim nije moguće dati preporuku o doziranju.
Check the appearance of Ristempa.
Provjerite izgled Ristempe.