natgillin/translations-raw huggingface dataset:
Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Dovato je zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki tehtajo vsaj 40 kg, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1).
How does Dovato work?
Kako zdravilo Dovato deluje?
In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
V dveh glavnih študijah je bila pri bolnikih z okužbo z virusom HIV-1 kombinacija dveh učinkovin v zdravilu Dovato enako učinkovita kot kombinacija treh učinkovin, pri čemer pa pri teh bolnikih ni bil ugotovljen noben primer razvoja odpornosti.
How is Dovato used?
Kako se zdravilo Dovato uporablja?
For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Bolnik mora vzeti eno tableto na dan. Za več informacij glede uporabe zdravila Dovato glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Evropska agencija za zdravila je zato sklenila, da so koristi zdravila Dovato večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
3 (3x1) inhalers (360(3x120) actuations) (multipack)
3 (3 x 1) inhalatorji (360 (3 x 120) sprožitev) (skupno pakiranje)
1 inhaler (120 actuations)
1 inhalator (120 sprožitev)
Strength Pharmaceutical Form
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
There is no specific antidote.
Ne obstaja specifičen antidot.
Take the next dose normally, when it is time to take it.
Naslednji odmerek vzemite kot običajno, ko je čas, da ga vzamete.
• Not known (frequency cannot be estimated from the available data)
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Any suspicious skin lesion should be evaluated by a specialist.
Vsako sumljivo kožno lezijo mora oceniti specialist.
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Izražen je bil tudi pomemben in koristen učinek na kvaliteto življenja (ocenjeno s PD-QUALIF lestvico).
597 678 01 Blansko Czech Republic
597 678 01 Blansko Češka Republika
The effect was evident, although its magnitude was modest in this patient population with mild disease.
Učinek je bil očiten, čeprav je bil njegov obseg v tej populaciji z blago boleznijo zmeren.
The frequency of possible side effects listed below is defined using the following convention:
Pogostost spodaj navedenih možnih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom:
Your doctor may need to adjust or stop your dose.
Zdravnik bo moral morda prilagoditi odmerek ali prekiniti zdravljenje.
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
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).
Moč rezultatov za primarno merilo končne učinkovitosti je bila potrjena v bateriji dodatnih statističnih modelov in prikazana v treh kohortah (ITT, na protokol in zaključene).
In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day.
V študiji z enojnimi odmerki so zdravi prostovoljci dobili odmerek 20 mg/dan in v desetdnevni študiji so zdravi prostovoljci prejemali odmerek 10 mg/dan.
Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Uporaba razagilina pri otrocih in mladostnikih ni priporočljiva zaradi nezadostnih podatkov o varnosti in učinkovitosti.
Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that Rasagiline does not affect them adversely.
Bolnike je potrebno opozoriti, naj ne upravljajo nevarnih strojev, vključno z motornimi vozili, dokler niso ustrezno prepričani, da razagilin na njih ne vpliva škodljivo.
Adverse events were mild or moderate and not related to rasagiline treatment.
Neželeni učinki so bili blagi ali zmerni in niso bili povezani z zdravljenjem z razagilinom.
Elderly No change in dose is required for elderly patients.
Za starejše bolnike ni potrebno spreminjanje odmerka.
Less than 1% of rasagiline is excreted as unchanged product in urine.
Manj kot 1% razagilina se izloči nespremenjenega z urinom.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Dopamine is a chemical in the brain involved in movement control.
Dopamin je kemična snov v možganih, ki sodeluje pri nadzorovanju gibanja.
Patients should be regularly monitored for the development of impulse control disorders.
Bolnike je treba redno spremljati zaradi možnosti razvoja motenj pri obvladovanju impulzov.
In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
V primerih prevelikega odmerjanja je potrebno bolnika opazovati ter uvesti ustrezno simptomatsko in podporno zdravljenje.
Parkinson's disease is associated with symptoms of hallucinations and confusion.
Parkinsonovo bolezen spremljajo simptomi halucinacij in zmedenosti.
Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
V obeh študijah je bilo primarno merilo učinkovitosti sprememba povprečnega števila ur v dnevu, preživetih v »OFF« stanju od izhodišča do konca zdravljenja (opredeljenih iz »24-urnih« domačih dnevnikov, ki so bili zaključeni 3 dni pred vsakim ocenjevalnim obiskom).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta ali če kadite oziroma nameravate opustiti kajenje.
The absolute bioavailability of a single rasagiline dose is about 36%.
Absolutna biološka uporabnost enkratnega odmerka razagilina je okoli 36%.
There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Tudi v skupini z 0,5 mg razagilina je bilo v primerjavi s placebom statistično pomembno izboljšanje, vendar je bil obseg izboljšanja manjši.
Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Razagilin ne izraža genotoksičnega potenciala v in vivo in v številnih in vitro sistemih, ki uporabljajo bakterije ali hepatocite.
The mean volume of distribution following a single intravenous dose of rasagiline is 243 l.
Povprečni volumen porazdelitve, ki sledi enkratnemu intravenskemu odmerku razagilina, je 243 l.
Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.
Razagilin se daje peroralno v odmerku 1 mg enkrat dnevno, z ali brez levodope.
Children and adolescents Rasagiline Mylan is not recommended for use under the age of 18.
Otroci in mladostniki Jemanje zdravila Razagilin Mylan ni priporočeno za mlajše od 18 let.
Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Razagilin se hitro absorbira, vrh plazemske koncentracije (Cmax) doseže v približno v 0,5 ure.
Patients with Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues.
Bolniki s Parkinsonovo boleznijo so še posebej ranljivi na neželene učinke hipotenzije zaradi obstoječe problematike s hojo.
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 vpliva na Tmax razagilina, čeprav se Cmax in izpostavljenost (AUC) zmanjšata za približno 60% oz. 20%, ko se zdravilo vzame z zelo mastnim obrokom.
Rasagiline Mylan is used for the treatment of Parkinson's disease.
Zdravilo Razagiline Mylan se uporablja pri zdravljenju Parkinsonove bolezni.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu.
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 pri odmerkih od 0,5 do 2 mg. Njegov končni razpolovni čas je 0,6 do 2 uri.
During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
V času programa kliničnega razvoja je pojavnost primerov melanoma nakazovala možnost povezave z razagilinom.
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).
Neželeni učinki so navedeni glede na pogostnost ob upoštevanju sledečih dogovorov: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
For rasagiline no clinical data on exposed pregnancies is available.
Za razagilin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
It is not known whether rasagiline is excreted in human milk.
Ni znano, ali se razagilin izloča v materino mleko.
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 študijah: kot monoterapija v študiji I in kot dodatna terapija k levodopi v študijah II in III.
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.
Sekundarna merila učinkovitosti so vključevala ocenjevalčevo globalno oceno izboljšanja, dosežene točke na podlestvici Vprašalnika vsakodnevnih aktivnosti (Activities of Daily Living -ADL) v času OFF in motorični UPDRS v času ON. Razagilin je dosegel statistično pomembno korist v primerjavi s placebom.
Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors, ATC code: N04BD02
Farmakoterapevtska skupina: antiparkinsoniki, zaviralci monoaminooksidaz tipa B, oznaka ATC: N04BD02
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
1-aminoindan je aktivni glavni presnovek in ni inhibitor MAO-B.
Overdose can be associated with significant inhibition of both MAO-A and MAO-B.
Preveliki odmerki so lahko povezani s pomembno inhibicijo tako MAO-A kot MAO-B.
Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum.
Razagilin se je pokazal kot močan, ireverzibilen selektiven inhibitor MAO-B, ki lahko povzroča povišanje izvencelične ravni dopamina v striatumu.
Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain.
Zdravilo Razagiline Mylan pomaga zvišati in vzdrževati raven dopamina v možganih.
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).
O podobnem vzorcu motenj nadzora impulzov so poročali v obdobju trženja z razagilinom, ki je vključeval tudi kompulzije, obsesivne misli in impulzivno vedenje (glejte poglavje 4.4).
There are a number of known interactions between non-selective MAO inhibitors and other medicinal products.
Obstajajo številne znane interakcije med neselektivnimi inhibitorji MAO in drugimi zdravili.
These symptoms may resemble those observed with non-selective MAO inhibitors.
Ti simptomi so lahko podobni simptomom, ki jih je mogoče opaziti pri neselektivnih inhibitorjih MAO.
In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 3,076.4 patient years.
V kliničnem programu razagilina je bilo 1.361 bolnikov zdravljenih z razagilinom 3.076,4 bolnikovlet.
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.
C-označenim razagilinom nastopi izločanje v glavnem preko urina (62,6%) in sekundarno preko blata (21,8%), s celotnim izločanjem 84,4% odmerka v obdobju 38 dni.
117, Allée des Parcs, 69800 Saint-Priest France
117, Allée des Parcs, 69800 Saint-Priest Francija
With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.
Pri Parkinsonovi bolezni nastopi izguba celic, ki v določenih možganskih področjih tvorijo dopamin.
In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
Pri osebah z zmerno jetrno okvaro sta AUC in Cmax porasla za 568% oz. 83% (glejte poglavje 4.4).
The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate rasagiline's beneficial effects seen in models of dopaminergic motor dysfunction.
Povišana raven dopamina in posledično povečana dopaminergična aktivnost verjetno prenašata koristne učinke razagilina, opazovane v modelih dopaminergičnih motoričnih disfunkcij.
The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-Aminoindan, 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.
117, Allée des Parcs 69800 Saint-Priest France
117, Allée des Parcs 69800 Saint-Priest Francija
It can be used together with or without levodopa (another medicine that is used to treat Parkinson's disease).
Lahko se ga uporablja z levodopo (drugo zdravilo za zdravljenje Parkinsonove bolezni) ali brez nje.
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 se morajo uporabljati previdno.
Plasma protein binding following a single oral dose of
Plazemska proteinska vezava, ki sledi enojnemu odmerku s
There have been cases of patients who, while taking one or more medications for the treatment of Parkinson's disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others.
Znani so primeri, ko so se bolniki med jemanjem enega ali več zdravil za zdravljenje Parkinsonove bolezni bili nezmožni upirati nagibom, željam ali skušnjavam, da bi izvajali določene dejavnosti, ki bi lahko bile škodljive za njih same ali za druge.
C-labelled rasagiline is approximately 60 to
C-označenim razagilinom, je približno
Because AUC is not substantially affected, rasagiline can be administered with or without food.
Ker AUC ni bistveno spremenjen, se razagilin lahko jemlje s hrano ali brez nje.
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 tablet 10 tablet 28 tablet 30 tablet 100 tablet 112 tablet 7 x 1 tableta 10 x 1 tableta 28 x 1 tableta 30 x 1 tableta 100 x 1 tableta 112 x 1 tableta
The use of Rasagiline Mylan together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Potrebno se je izogibati uporabi zdravila Razagilin Mylan skupaj z antidepresivi, ki vsebujejo fluoksetin ali fluvoksamin.
Impulse control disorders
Motnje pri obvladovanju impulzov
Take the Rasagiline Mylan carton with you to show the doctor or pharmacist.
S seboj vzemite škatlo zdravila Razagilin Mylan, da jo boste lahko pokazali zdravniku ali farmacevtu.
Manufacturer Mylan Hungary Kft, Mylan utca 1
Izdelovalec Mylan Hungary Kft, Mylan utca 1
In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Prav tako so, pri približno 1% bolnikov v s placebom nadzorovanih kliničnih preskušanjih, poročali o kožnem karcinomu.
Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
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.
Interakcije tiramin/razagilin: 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 šest mesečne terapije k levodopi brez omejitve tiramina) in dejstva, da ni poročil o interakcijah tiramin/razagilin v kliničnih študijah, ki so bile izvajane brez omejitve tiramina, kažejo na to, da se lahko razagilin varno uporablja brez dietne omejitve tiramina.
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.
Zdravniku povejte, če sami ali kdo v vaši družini ali vaš skrbnik opazi za vas neobičajno vedenje, da se ne morete upirati nagibom, željam ali skušnjavi, da bi izvajali določene dejavnosti, ki so lahko škodljive za vas ali druge.
Since rasagiline potentiates the effects of levodopa, the adverse effects 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.
These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Glede na te rezultate ni verjetno, da bi terapevtske koncentracije razagilina klinično pomembno součinkovale s substrati teh encimov.
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).
Vendar pa znanstveni dokazi nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Obstaja možnost, da so pri kadilcih znižane plazemske ravni razagilina zaradi indukcije metabolnega encima CYP1A2.
These are called impulse control disorders.
Tako vedenje imenujemo motnje pri obvladovanju impulzov.
Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline.
Vsaka tableta vsebuje razagilinijev tartrat, kar ustreza 1 mg razagilina.
Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, 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 disforijo, hipomanijo, hipertenzivno krizo in serotoninski sindrom.
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).
Zbrani podatki nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z višjim tveganjem karcinoma kože (ne izključno melanoma).
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.
Zdravilo Razagilin Mylan je indicirano za zdravljenje idiopatske Parkinsonove bolezni (PB) kot monoterapija (brez levodope) ali kot dodatna terapija (z levodopo) pri bolnikih z nihanji končnih odmerkov.
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%.
Do not take Rasagiline Mylan: - if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Razagiline Mylan: če ste alergični na razagilin ali katero koli sestavino tega zdravila (navedeno v poglavju 6), če imate hude težave z jetri.
Co-administration of rasagiline and theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
Sočasna uporaba razagilina in teofilina (substrat CYP1A2) ni vplivala na njuno farmakokinetiko.
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.
Razagilin v prisotnosti aktivacije metabolita povzroča porast kromosomskih aberacij v koncentracijah z obsežno citotoksičnostjo, ki v kliničnih pogojih uporabe niso dosežene.