natgillin/translations-raw huggingface dataset:
VANCOMYCIN HYDROCHLORIDE 1000 mg bottle
VANKOMICINIJEV KLORID 1000 MG STEKLENIČKA
Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 1G BOTTLE
Vancomycin Mylan VANKOMICINIJEV KLORID 1 G
VANCOMYCIN 250MG CAPSULE
VANKOMICIN 250 MG KAPSULA
Vancomycin Vocate VANCOMYCIN 500MG VIAL
Vancomycin Vocate VANKOMICIN 500 MG VIALA
VANCOMYCIN HYDROCHLORIDE 512MG VIAL
VANKOMICINIJEV KLORID 512 MG VIALA
Vancomicina Axelia Vancomycin hydrochloride 1000 vial
Vancomicina Axelia VANKOMICINIJEV KLORID 1000 MG
POWDER FOR SOLUTION FOR
PRAŠEK ZA RAZTOPINO ZA
Vancomycin Actavis VANCOMYCIN 500MG VIAL
Vancomycin Actavis VANKOMICIN 500 MG VIALA
VANCOMYCIN HYDROCHLORIDE 0.5G BOTTLE
VANKOMICINIJEV KLORID 0,5 G STEKLENIČKA
VANCOMYCIN HYDROCHLORIDE 1MG VIAL
VANKOMICINIJEV KLORID 1 MG VIALA
Vancomycin Mip VANCOMYCIN 1000MG VIAL
Vancomycin Mip VANKOMICIN 1000 MG VIALA
Fresenius Kabi ванкомицин каби VANCOMYCIN 500MG POWDER FOR
Fresenius Kabi Bulgaria Eood ванкомицин каби VANKOMICIN 500 MG PRAŠEK ZA KONCENTRAT ZA
Vancomycin Hikma VANCOMYCIN 1000MG VIAL
Vancomycin Hikma VANKOMICIN 1000 MG VIALA
Voxin® 500mg/Vial
Voxin® 500mg/Vial VANKOMICIN 500 MG VIALA
Vancomycin Hikma VANCOMYCIN 500MG VIAL
Vancomycin Hikma VANKOMICIN 500 MG VIALA
POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION
PRAŠEK ZA PERORALNO RAZTOPINO ALI PRAŠEK ZA RAZTOPINO ZA INJICIRANJE
POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION
PRAŠEK ZA RAZTOPINO ZA INFUNDIRANJE / PRAŠEK ZA PERORALNO RAZTOPINO
476.19MG VIAL
VANKOMICINIJEV KLORID 476,19 MG VIALA
INFUSION
INFUNDIRANJE
SOLUTION FOR INJECTION
RAZTOPINO ZA INJICIRANJE
CONCENTRATE FOR SOLUTION FOR INFUSION
KONCENTRAT ZA PRIPRAVO RAZTOPINE ZA INFUNDIRANJE
Vancomycine Teva VANCOMYCIN 500MG VIAL
Vancomycine Teva VANKOMICIN 500 MG VIALA
Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN
Hospira Enterprise Vancomycin
VANCOMYCIN HYDROCHLORIDE 510MG VIAL
VANKOMICINIJEV KLORID 510 MG VIALA
VANCOMYCIN HYDROCHLORIDE 1G VIAL
VANKOMICINIJEV KLORID 1 G VIALA
Vancomicina Axelia Vancomycin hydrochloride 500 vial
Vancomicina Axelia VANKOMICINIJEV KLORID 500 MG
Vancomycine Mylan VANCOMYCIN 1000MG VIAL
Vancomycin Mylan VANKOMICIN 1000 MG VIALA
Hospira Uk Ltd Vancomycin Hydrochloride
Hospira Uk Ltd VANKOMICINIJEV KLORIDHospira
Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 1000MG VIAL
Mip Pharma Gmbh ванкомицин Mip VANKOMICIN 1000 MG VIALA
United Kingdom Nrim Limited
Generics [uk] Limited
Vancomycin Mip VANCOMYCIN 500MG VIAL
Vancomycin Mip VANKOMICIN 500 MG VIALA
HYDROCHLORIDE 1020MG VIAL
VANKOMICINIJEV KLORID 1020 MG VIALA
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycin "cnp" VANKOMICIN 500 MG VIALA
Vancomycin Xellia VANCOMYCIN
Vancomycin Xellia VANKOMICINIJEV PRAŠEK ZA
Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Nrim Limited Vancomycin Nrim VANKOMICIN 1000 MG VIALA
VANCOMYCIN Hydrochloride 1000MG VIAL
VANKOMICINIJEV KLORID 1000 MG VIALA
Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG VIAL
Mip Pharma Gmbh ванкомицин Mip VANKOMICIN 500 MG VIALA
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vancomycin "cnp" VANKOMICIN 1000 MG VIALA
POWDER FOR ORAL SOLUTION
PRAŠEK ZA PERORALNO RAZTOPINO
Vancomycin Mylan VANCOMYCIN 500MG VIAL
Vancomycin Mylan VANKOMICIN 500 MG VIALA
HYDROCHLORIDE 1025MG VIAL
VANKOMICINIJEV KLORID1025 MG VIALA
VANCOMYCIN HYDROCHLORIDE 500000 I.U.
VANKOMICINIJEV KLORID 500000 I.E. VIALA
Vancomycine Mylan VANCOMYCIN 500MG VIAL
Vancomycine Mylan VANKOMICIN 500 MG VIALA
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL
Mip Pharma Gmbh Vancomycin Mip VANKOMICIN 1000 MG VIALA
VANCOMYCIN Hydrochloride 500MG bottle
VANKOMICINIJEV KLORID 500 MG STEKLENIČKA
Vancomycin Norma VANCOMYCIN 500MG VIAL
Norma Hellas S.A. Vancomycin Norma VANKOMICIN 500 MG VIALA
HYDROCHLORIDE 50MG/ML
VANKOMICINIJEV KLORID 50 MG/ML
Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg vial
Vancomicina Hikma VANKOMICINIJEV KLORID 500 MG
Vancomycine Mylan VANCOMYCIN HYDROCHLORIDE
Vancomycin Mylan VANKOMICINIJEV PRAŠEK ZA
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL
Mip Pharma Gmbh Vancomycin Mip VANKOMICIN 500 MG VIALA
VANCOMYCIN 125MG CAPSULE
VANKOMICIN 125 MG KAPSULA
Vancomicina Hikma VANCOMYCIN Hydrochloride
Vancomicina Hikma VANKOMICINIJEV KLORID1000 MG
Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL
Vancomycin Hexal VANKOMICINIJEV KLORID 1 G VIALA
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vancomycine Cnp VANKOMICIN 1000 MG VIALA
Vancomycin Nrim VANCOMYCIN 500MG VIAL
Nrim Limited Vancomycin Nrim VANKOMICIN 500 MG VIALA
SOLUTION FOR INJECTION/INFUSION
PRAŠEK ZA RAZTOPINO ZA INJICIRANJE / INFUNDIRANJE
VANCOMYCIN HYDROCHLORIDE 1000MG
Vancomicina Hikma VANKOMICINIJEV KLORID 1000 MG
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycin Cnp VANKOMICIN 500 MG VIALA
Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG VIAL
VANKOMICIN 1000 MG IN 500 MG VIALA
Vancomicina Pfizer VANCOMYCIN 1000MG VIAL
Vancomicina Pfizer VANKOMICIN 1000 MG VIALA
Vancomycin Pfizer VANCOMYCIN 1000MG VIAL
Vancomycin Pfizer VANKOMICIN 1000 MG VIALA
Vankomicin Pfizer VANCOMYCIN 1000MG VIAL
Vankomicin Pfizer VANKOMICIN 1000 MG VIALA
Vancomicina Pfizer VANCOMYCIN 500MG VIAL
Vancomicina Pfizer VANKOMICIN 500 MG VIALA
VANCOMYCIN HYDROCHLORIDE 1000000 I.U.
VANKOMICINIJEV KLORID 1000000 I.E. VIALA
INHALATION USE
ZA INHALIRANJE
VANCOMYCIN HYDROCHLORIDE 500MG
VANKOMICINIJEV KLORID 500 MG
VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE
VANKOMICINIJEV KLORID 250 MG KAPSULA
Vancomycin Hexal
Vancomycin Generics
POWDER FOR INFUSION
RAZTOPINO ZA INFUNDIRANJE
Vancomycine Pfizer VANCOMYCIN 500MG VIAL
Vancomycine Pfizer VANKOMICIN 500 MG VIALA
VANCOMYCIN HYDROCHLORIDE 500MG VIAL
VANKOMICINIJEV KLORID 500 MG VIALA
Vankomicin Pfizer VANCOMYCIN 500MG VIAL
Vankomicin Pfizer VANKOMICIN 500 MG VIALA
Vancomycin Pfizer VANCOMYCIN 500MG VIAL
Vancomycin Pfizer VANKOMICIN 500 MG VIALA
Teva Nederland B.V. Vancomycine Teva VANCOMYCIN 500MG VIAL
Teva Denmark A-S Vancomycin Teva VANKOMICINIJEV KLORID 500 MG/MG
Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycine Cnp VANKOMICIN 500 MG VIALA
Vancomicina Sala VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Vancomicina Sala VANKOMICIN 1 G VIALA
VANCOMYCIN HYDROCHLORIDE 1000MG/1000 MG
VANKOMICINIJEV KLORID1000 MG
Vancomycine Xellia VANCOMYCIN HYDROCHLORIDE
Vancomycine Xellia VANKOMICINIJEV KLORID 513 MG
Adults and adolescents can use any form of the medicine.
Odrasli in mladostniki lahko uporabljajo katero koli farmacevtsko obliko zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Evropska komisija je dovoljenje za promet z zdravilom Neoclarityn, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2001.
The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neoclarityn je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The side effects seen in children are similar.
Pri otrocih so bili opaženi podobni neželeni učinki.
This is a summary of the European public assessment report (EPAR) for Neoclarityn.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Neoclarityn.
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Predstavili so dodatne študije, da se dokaže, da sirup, peroralna raztopina in orodisperzibilne tablete telo presnavlja enako kot tablete in da se lahko varno uporabijo pri otrocih.
Neoclarityn has also been studied in 416 patients with urticaria.
Zdravilo Neoclarityn so proučevali tudi pri 416 bolnikih z urtikarijo.
What benefit has Neoclarityn shown during the studies?
Kakšne koristi je zdravilo Neoclarityn izkazalo med študijami?
For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Neoclarityn preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
V vseh študijah so učinkovitost zdravila Neoclarityn primerjali s placebom (zdravilom brez zdravilne učinkovine).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neoclarityn.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Neoclarityn, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Zdravilo Neoclarityn so raziskali v osmih študijah, v katerih je sodelovalo približno 4 800 odraslih in mladostnikov z alergijskim rinitisom (vključno s štirimi študijami sezonskega alergijskega rinitisa in dvema študijama pri bolnikih, ki so imeli tudi astmo).
It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Na voljo je v obliki 5-miligramskih tablet, 2,5- in 5-miligramskih orodisperzibilnih tablet (tablet, ki se raztopijo v ustih), sirupa s koncentracijo 0,5 mg/ml in peroralne raztopine s koncentracijo 0,5 mg/ml.
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Pri odraslih so najpogostejši neželeni učinki utrujenost (1,2 %), suha usta (0,8 %) in glavobol (0,6 %).
Neoclarityn is a medicine containing the active substance desloratadine.
Neoclarityn je zdravilo, ki vsebuje zdravilno učinkovino desloratadin.
Other information about Neoclarityn
Druge informacije o zdravilu Neoclarityn:
Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Zdravila Neoclarityn ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, loratadin ali katero koli drugo sestavino zdravila.
What is the risk associated with Neoclarityn?
Kakšna tveganja so povezana z zdravilom Neoclarityn?
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
V dveh študijah pri bolnikih z urtikarijo se je število simptomov po šestih tednih zdravljenja z zdravilom Neoclarityn zmanjšalo za 58 % in 67 %, pri bolnikih, ki so prejemali placebo, pa za 40 % in 33 %.
The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Priporočeni odmerek za odrasle in mladostnike (stare 12 let in več) je 5 mg enkrat na dan. Odmerek za otroke je odvisen od njihove starosti.
For the full list of all side effects reported with Neoclarityn, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neoclarityn, glejte navodilo za uporabo.
In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Pri otrocih do 2. leta starosti so bili najpogostejši neželeni učinki driska (3,7 %), zvišana telesna temperatura (2,3 %) in nespečnost (2,3 %).
Why has Neoclarityn been approved?
Zakaj je bilo zdravilo Neoclarityn odobreno?
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Dvotedensko zdravljenje z zdravilom Neoclarityn 5 mg je pri alergijskem rinitisu v vseh študijah skupaj privedlo do zmanjšanja števila simptomov za povprečno 25 % do 32 %, v primerjavi z 12- do 26-odstotnim zmanjšanjem pri bolnikih, ki so prejemali placebo.
Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Zdravilo Neoclarityn se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
Učinkovitost so merili s spremembami simptomov (srbenje, število in velikost izpuščajev, motnje spanja in dnevna dejavnost), ki so jih opazovali pred zdravljenjem in šest tednov po zaključku zdravljenja.
The CHMP decided that Neoclarityn's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Neoclarityn pri lajšanju simptomov alergijskega rinitisa ali urtikarije večji od z njim povezanih tveganj, in priporočil da se zanj odobri dovoljenje za promet.
The active substance in Neoclarityn, desloratadine, is an antihistamine.
Zdravilna učinkovina zdravila Neoclarityn je desloratadin, ki je antihistaminik.
For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
Otroci, ki so stari od 1 do 5 let, prejemajo odmerek 1,25 mg enkrat dnevno v obliki 2,5 ml sirupa ali peroralne raztopine.
For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Otroci, stari od 6 do 11 let, pa prejemajo odmerek 2,5 mg enkrat dnevno v obliki 5 ml sirupa ali peroralne raztopine oziroma ene 2,5-miligramske orodisperzibilne tableto.
The effectiveness of Neoclarityn was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Učinkovitost zdravila Neoclarityn so merili s spremembo simptomov (izcedek iz nosu, srbenje, kihanje in zamašenost nosu), ki so jih opazili pred zdravljenjem in dva do štiri tedne po zaključku zdravljenja.
It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
What is Neoclarityn used for?
Za kaj se zdravilo Neoclarityn uporablja?
How has Neoclarityn been studied?
Kako je bilo zdravilo Neoclarityn raziskano?
What is Neoclarityn?
Kaj je zdravilo Neoclarityn?
How is Neoclarityn used?
Kako se zdravilo Neoclarityn uporablja?
How does Neoclarityn work?
Kako zdravilo Neoclarityn deluje?
These cases were considered serious in all reports.
Ti primeri so bili v vseh poročilih obravnavani kot resni.
Some of these events have been reported more than 1-year after initiation of treatment.
O nekaterih izmed teh dogodkov so poročali več kot 1 leto po uvedbi zdravljenja.
Prilaz baruna Filipovica 25 10000 Zagreb Croatia
Prilaz baruna Filipovica 25 10000 Zagreb Hrvaška
There is no specific antidote.
Specifičen antidot ne obstaja.
Not known: frequency cannot be estimated from the available data
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Only single cases of reported cases had not recovered at the time they were reported.
Samo posamezni bolniki izmed poročanih primerov niso okrevali v času poročanja primera.
Tell your doctor or pharmacist if you are smoking or intend to stop smoking.
Obvestite zdravnika ali farmacevta, če kadite ali nameravate prenehati kaditi.
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).
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).
Less than 1% of rasagiline is excreted as unchanged product in urine.
Manj kot 1 % razagilina se izloči nespremenjenega z urinom.
This leaflet was last revised in MM/YYYY.
Navodilo je bilo nazadnje revidirano MM/LLLL.
Adverse reactions 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.
Your doctor may need to adjust or stop your dose (see section 4).
Vaš zdravnik vam bo moral morda prilagoditi odmerek ali prekiniti zdravljenje (glejte poglavje 4).
Smoking could decrease the amount of Rasagiline ratiopharm in the blood.
Kajenje lahko zmanjša količino zdravila Razagilin ratiopharm v krvi.
The absolute bioavailability of a single rasagiline dose is about 36%.
Absolutna biološka uporabnost enkratnega odmerka razagilina je okoli 36 %.
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 visokim tveganjem karcinoma kože (ne izključno melanoma).
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 izhodiščna sprememba povprečnega števila ur v dnevu, preživetih v »OFF« stanju (opredeljenih iz »24-urnih« domačih dnevnikov, ki so bili zaključeni 3 dni pred vsakim ocenjevalnim obiskom).
Adverse reactions are listed below in Tables 1 and 2 by system organ class and 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), not known (cannot be estimated from the available data).
Neželeni učinki so navedeni spodaj v preglednicah 1 in 2 po organskih sistemih in pogostnosti 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki ali pretisnem omotu poleg oznake »EXP«.
These adverse reactions were not associated with an elevated rate of drug discontinuation.
Ti neželeni učinki niso bili povezani s povišano stopnjo prekinitve zdravljenja.
- Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
- povišan krvni tlak - prekomerna zaspanost - nenadni spanec
No change in dose is required for elderly patients (see section 5.2).
Za starejše bolnike ni potrebno spreminjanje odmerka (glejte poglavje 5.2).
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 treba opozoriti, naj ne upravljajo nevarnih strojev, vključno z motornimi vozili, dokler niso ustrezno prepričani, da razagilin na njih ne vpliva škodljivo.
Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2)
Starost ima zelo malo vpliva na farmakokinetiko razagilina pri starejših (> 65 let) (glejte poglavje 4.2)
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.
Patients with Parkinson's disease are particularly vulnerable to the adverse reactions of hypotension due to existing gait issues.
Bolniki s Parkinsonovo boleznijo so še posebej ranljivi na neželene učinke hipotenzije zaradi obstoječe problematike s hojo.
These symptoms may resemble those observed with nonselective MAO inhibitors.
Ti simptomi so lahko podobni simptomom, ki jih je mogoče opaziti pri neselektivnih inhibitorjih MAO.
Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD02
Farmakoterapevtska skupina: antiparkinsoniki, zaviralci monoaminooksidaz tipa B, oznaka ATC: N04BD02
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7).
Bolniki, ki so doživeli somnolenco in/ali epizodo nenadnega spanca, se morajo vzdržati vožnje ali upravljanja strojev (glejte poglavje 4.7).
Other medicines and Rasagiline ratiopharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Razagilin ratiopharm Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Although many of these patients reported somnolence while on rasagiline with other dopaminergic medicinal products, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Čeprav je veliko od teh bolnikov poročalo o somnolenci med jemanjem razagilina z drugimi dopaminergičnimi zdravili, so nekateri zaznali, da niso imeli nobenih opozorilnih znakov, kot je na primer prekomerna zaspanost, in so menili, da so opozorilo zaznali šele tik pred dogodkom.
There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
V skupini z 0,5 mg razagilinom je bilo v primerjavi s placebom statistično pomembno izboljšanje, vendar je bil obseg izboljšanja manjši.
Depression, Hallucinations*
Psihiatrične motnje depresija, halucinacije*
Talk to your doctor before taking Rasagiline ratiopharm - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Pred začetkom jemanja zdravila Razagilin ratiopharm se posvetujte z zdravnikom - če imate kakršne koli težave z jetri, - če imate kakršne koli sumljive kožne spremembe, se morate pogovoriti z zdravnikom.
7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
7 tablet 10 tablet 28 tablet 30 tablet 100 tablet 112 tablet 10 x 1 tableta 30 x 1 tableta 100 x 1 tableta
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, ireverzibilni selektivni inhibitor MAO-B, ki lahko povzroča povišanje izvencelične ravni dopamina v striatumu.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with rasagiline.
Bolnike je treba o tem obvestiti in jim svetovati previdnost med vožnjo in upravljanjem strojev, medtem ko se zdravijo z razagilinom.
Skin melanoma*
kožni melanom*
SNRI/SSRI/tri- and tetracyclic antidepressants
SSRI/SNRI/triciklični in tetraciklični antidepresivi