FrancophonIA/ELRC3.0 huggingface dataset:
English: Vancomicina Axelia Vancomycin hydrochloride 1000 vial
Slovenian: Vancomicina Axelia VANKOMICINIJEV KLORID 1000 MG
English: POWDER FOR SOLUTION FOR
Slovenian: PRAŠEK ZA RAZTOPINO ZA
English: Vancomycin Actavis VANCOMYCIN 500MG VIAL
Slovenian: Vancomycin Actavis VANKOMICIN 500 MG VIALA
English: VANCOMYCIN HYDROCHLORIDE 0.5G BOTTLE
Slovenian: VANKOMICINIJEV KLORID 0,5 G STEKLENIČKA
English: VANCOMYCIN HYDROCHLORIDE 1MG VIAL
Slovenian: VANKOMICINIJEV KLORID 1 MG VIALA
English: Vancomycin Mip VANCOMYCIN 1000MG VIAL
Slovenian: Vancomycin Mip VANKOMICIN 1000 MG VIALA
English: Fresenius Kabi ванкомицин каби VANCOMYCIN 500MG POWDER FOR
Slovenian: Fresenius Kabi Bulgaria Eood ванкомицин каби VANKOMICIN 500 MG PRAŠEK ZA KONCENTRAT ZA
English: Vancomycin Hikma VANCOMYCIN 1000MG VIAL
Slovenian: Vancomycin Hikma VANKOMICIN 1000 MG VIALA
English: Voxin® 500mg/Vial
Slovenian: Voxin® 500mg/Vial VANKOMICIN 500 MG VIALA
English: Vancomycin Hikma VANCOMYCIN 500MG VIAL
Slovenian: Vancomycin Hikma VANKOMICIN 500 MG VIALA
English: POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION
Slovenian: PRAŠEK ZA PERORALNO RAZTOPINO ALI PRAŠEK ZA RAZTOPINO ZA INJICIRANJE
English: POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION
Slovenian: PRAŠEK ZA RAZTOPINO ZA INFUNDIRANJE / PRAŠEK ZA PERORALNO RAZTOPINO
English: 476.19MG VIAL
Slovenian: VANKOMICINIJEV KLORID 476,19 MG VIALA
English: Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE
Slovenian: Sandoz Gmbh Vancomycin Sandoz
English: INFUSION
Slovenian: INFUNDIRANJE
English: SOLUTION FOR INJECTION
Slovenian: RAZTOPINO ZA INJICIRANJE
English: CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: KONCENTRAT ZA PRIPRAVO RAZTOPINE ZA INFUNDIRANJE
English: Vancomycine Teva VANCOMYCIN 500MG VIAL
Slovenian: Vancomycine Teva VANKOMICIN 500 MG VIALA
English: Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN
Slovenian: Hospira Enterprise Vancomycin
English: VANCOMYCIN HYDROCHLORIDE 510MG VIAL
Slovenian: VANKOMICINIJEV KLORID 510 MG VIALA
English: VANCOMYCIN HYDROCHLORIDE 1G VIAL
Slovenian: VANKOMICINIJEV KLORID 1 G VIALA
English: Vancomycin Mylan VANCOMYCIN 500MG/ML
Slovenian: Vancomycin Mylan VANKOMICIN 500 MG/ML
English: Vancomicina Axelia Vancomycin hydrochloride 500 vial
Slovenian: Vancomicina Axelia VANKOMICINIJEV KLORID 500 MG
English: Vancomycine Mylan VANCOMYCIN 1000MG VIAL
Slovenian: Vancomycin Mylan VANKOMICIN 1000 MG VIALA
English: Hospira Uk Ltd Vancomycin Hydrochloride
Slovenian: Hospira Uk Ltd VANKOMICINIJEV KLORIDHospira
English: Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 1000MG VIAL
Slovenian: Mip Pharma Gmbh ванкомицин Mip VANKOMICIN 1000 MG VIALA
English: United Kingdom Nrim Limited
Slovenian: Generics [uk] Limited
English: Vancomycin Mip VANCOMYCIN 500MG VIAL
Slovenian: Vancomycin Mip VANKOMICIN 500 MG VIALA
English: Fresenius Kabi S.R.O Vancomycin Kabi
Slovenian: Fresenius Kabi S.R.O
English: Vankomicin Actavis VANCOMYCIN 500MG VIAL
Slovenian: Vankomicin Actavis VANKOMICIN 500 MG VIALA
English: HYDROCHLORIDE 1020MG VIAL
Slovenian: VANKOMICINIJEV KLORID 1020 MG VIALA
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Slovenian: Cnp Pharma Gmbh Vancomycin "cnp" VANKOMICIN 500 MG VIALA
English: Vancomycin Xellia VANCOMYCIN
Slovenian: Vancomycin Xellia VANKOMICINIJEV PRAŠEK ZA
English: Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Slovenian: Nrim Limited Vancomycin Nrim VANKOMICIN 1000 MG VIALA
English: VANCOMYCIN Hydrochloride 1000MG VIAL
Slovenian: VANKOMICINIJEV KLORID 1000 MG VIALA
English: Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG VIAL
Slovenian: Mip Pharma Gmbh ванкомицин Mip VANKOMICIN 500 MG VIALA
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
Slovenian: Cnp Pharma Gmbh Vancomycin "cnp" VANKOMICIN 1000 MG VIALA
English: POWDER FOR ORAL SOLUTION
Slovenian: PRAŠEK ZA PERORALNO RAZTOPINO
English: Vancomicina Mylan VANCOMYCIN 50MG/ML
Slovenian: Vancomicina Mylan VANKOMICIN 50 MG/ML
English: Vancomycin Mylan VANCOMYCIN 500MG VIAL
Slovenian: Vancomycin Mylan VANKOMICIN 500 MG VIALA
English: HYDROCHLORIDE 1025MG VIAL
Slovenian: VANKOMICINIJEV KLORID1025 MG VIALA
English: VANCOMYCIN HYDROCHLORIDE 500000 I.U.
Slovenian: VANKOMICINIJEV KLORID 500000 I.E. VIALA
English: Vancomycine Mylan VANCOMYCIN 500MG VIAL
Slovenian: Vancomycine Mylan VANKOMICIN 500 MG VIALA
English: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL
Slovenian: Mip Pharma Gmbh Vancomycin Mip VANKOMICIN 1000 MG VIALA
English: VANCOMYCIN Hydrochloride 500MG bottle
Slovenian: VANKOMICINIJEV KLORID 500 MG STEKLENIČKA
English: Vancomycin Norma VANCOMYCIN 500MG VIAL
Slovenian: Norma Hellas S.A. Vancomycin Norma VANKOMICIN 500 MG VIALA
English: HYDROCHLORIDE 50MG/ML
Slovenian: VANKOMICINIJEV KLORID 50 MG/ML
English: Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg vial
Slovenian: Vancomicina Hikma VANKOMICINIJEV KLORID 500 MG
English: Vancomycine Mylan VANCOMYCIN HYDROCHLORIDE
Slovenian: Vancomycin Mylan VANKOMICINIJEV PRAŠEK ZA
English: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL
Slovenian: Mip Pharma Gmbh Vancomycin Mip VANKOMICIN 500 MG VIALA
English: VANCOMYCIN 125MG CAPSULE
Slovenian: VANKOMICIN 125 MG KAPSULA
English: Vancomicina Hikma VANCOMYCIN Hydrochloride
Slovenian: Vancomicina Hikma VANKOMICINIJEV KLORID1000 MG
English: Hikma Farmacêutica Vancomycin Hikma VANCOMYCIN
Slovenian: Vancomycine Hikma
English: Vancomycin Mylan VANCOMYCIN 50MG/ML
Slovenian: Vancomycin Mylan VANKOMICIN 50 MG/ML
English: Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL
Slovenian: Vancomycin Hexal VANKOMICINIJEV KLORID 1 G VIALA
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Slovenian: Cnp Pharma Gmbh Vancomycine Cnp VANKOMICIN 1000 MG VIALA
English: Vancomycine Mylan VANCOMYCIN 50MG/ML
Slovenian: Vancomycine Mylan VANKOMICIN 50 MG/ML
English: Vancomycin Nrim VANCOMYCIN 500MG VIAL
Slovenian: Nrim Limited Vancomycin Nrim VANKOMICIN 500 MG VIALA
English: SOLUTION FOR INJECTION/INFUSION
Slovenian: PRAŠEK ZA RAZTOPINO ZA INJICIRANJE / INFUNDIRANJE
English: VANCOMYCIN HYDROCHLORIDE 1000MG
Slovenian: Vancomicina Hikma VANKOMICINIJEV KLORID 1000 MG
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Slovenian: Cnp Pharma Gmbh Vancomycin Cnp VANKOMICIN 500 MG VIALA
English: Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG VIAL
Slovenian: VANKOMICIN 1000 MG IN 500 MG VIALA
English: Vancomicina Pfizer VANCOMYCIN 1000MG VIAL
Slovenian: Vancomicina Pfizer VANKOMICIN 1000 MG VIALA
English: Vancomycin Pfizer VANCOMYCIN 1000MG VIAL
Slovenian: Vancomycin Pfizer VANKOMICIN 1000 MG VIALA
English: Vankomicin Pfizer VANCOMYCIN 1000MG VIAL
Slovenian: Vankomicin Pfizer VANKOMICIN 1000 MG VIALA
English: Vancomicina Pfizer VANCOMYCIN 500MG VIAL
Slovenian: Vancomicina Pfizer VANKOMICIN 500 MG VIALA
English: VANCOMYCIN HYDROCHLORIDE 1000000 I.U.
Slovenian: VANKOMICINIJEV KLORID 1000000 I.E. VIALA
English: INHALATION USE
Slovenian: ZA INHALIRANJE
English: VANCOMYCIN HYDROCHLORIDE 500MG
Slovenian: VANKOMICINIJEV KLORID 500 MG
English: VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE
Slovenian: VANKOMICINIJEV KLORID 250 MG KAPSULA
English: Vancomycin Hexal
Slovenian: Vancomycin Generics
English: POWDER FOR INFUSION
Slovenian: RAZTOPINO ZA INFUNDIRANJE
English: Vancomycine Pfizer VANCOMYCIN 500MG VIAL
Slovenian: Vancomycine Pfizer VANKOMICIN 500 MG VIALA
English: VANCOMYCIN HYDROCHLORIDE 500MG VIAL
Slovenian: VANKOMICINIJEV KLORID 500 MG VIALA
English: Vankomicin Pfizer VANCOMYCIN 500MG VIAL
Slovenian: Vankomicin Pfizer VANKOMICIN 500 MG VIALA
English: Vancomycin Pfizer VANCOMYCIN 500MG VIAL
Slovenian: Vancomycin Pfizer VANKOMICIN 500 MG VIALA
English: Teva Nederland B.V. Vancomycine Teva VANCOMYCIN 500MG VIAL
Slovenian: Teva Denmark A-S Vancomycin Teva VANKOMICINIJEV KLORID 500 MG/MG
English: Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG VIAL
Slovenian: Cnp Pharma Gmbh Vancomycine Cnp VANKOMICIN 500 MG VIALA
English: Vancomicina Sala VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Slovenian: Vancomicina Sala VANKOMICIN 1 G VIALA
English: VANCOMYCIN HYDROCHLORIDE 1000MG/1000 MG
Slovenian: VANKOMICINIJEV KLORID1000 MG
English: Fresenius Kabi Nv-Sa Vancomycine Fresenius Kabi
Slovenian: Fresenius Kabi NvSa
English: Vancomycine Xellia VANCOMYCIN HYDROCHLORIDE
Slovenian: Vancomycine Xellia VANKOMICINIJEV KLORID 513 MG
English: Adults and adolescents can use any form of the medicine.
Slovenian: Odrasli in mladostniki lahko uporabljajo katero koli farmacevtsko obliko zdravila.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Neoclarityn, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2001.
English: The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: 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.
English: The side effects seen in children are similar.
Slovenian: Pri otrocih so bili opaženi podobni neželeni učinki.
English: This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Neoclarityn.
English: 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.
Slovenian: 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.
English: Neoclarityn has also been studied in 416 patients with urticaria.
Slovenian: Zdravilo Neoclarityn so proučevali tudi pri 416 bolnikih z urtikarijo.
English: What benefit has Neoclarityn shown during the studies?
Slovenian: Kakšne koristi je zdravilo Neoclarityn izkazalo med študijami?
English: For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Slovenian: V vseh študijah so učinkovitost zdravila Neoclarityn primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Slovenian: Pri odraslih so najpogostejši neželeni učinki utrujenost (1,2 %), suha usta (0,8 %) in glavobol (0,6 %).
English: Neoclarityn is a medicine containing the active substance desloratadine.
Slovenian: Neoclarityn je zdravilo, ki vsebuje zdravilno učinkovino desloratadin.
English: Other information about Neoclarityn
Slovenian: Druge informacije o zdravilu Neoclarityn:
English: Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Slovenian: Zdravila Neoclarityn ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, loratadin ali katero koli drugo sestavino zdravila.
English: What is the risk associated with Neoclarityn?
Slovenian: Kakšna tveganja so povezana z zdravilom Neoclarityn?
English: 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.
Slovenian: 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 %.
English: The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Slovenian: 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.
English: For the full list of all side effects reported with Neoclarityn, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neoclarityn, glejte navodilo za uporabo.
English: 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%).
Slovenian: Pri otrocih do 2. leta starosti so bili najpogostejši neželeni učinki driska (3,7 %), zvišana telesna temperatura (2,3 %) in nespečnost (2,3 %).
English: Why has Neoclarityn been approved?
Slovenian: Zakaj je bilo zdravilo Neoclarityn odobreno?
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The active substance in Neoclarityn, desloratadine, is an antihistamine.
Slovenian: Zdravilna učinkovina zdravila Neoclarityn je desloratadin, ki je antihistaminik.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Slovenian: Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
English: What is Neoclarityn used for?
Slovenian: Za kaj se zdravilo Neoclarityn uporablja?
English: How has Neoclarityn been studied?
Slovenian: Kako je bilo zdravilo Neoclarityn raziskano?
English: What is Neoclarityn?
Slovenian: Kaj je zdravilo Neoclarityn?
English: How is Neoclarityn used?
Slovenian: Kako se zdravilo Neoclarityn uporablja?
English: How does Neoclarityn work?
Slovenian: Kako zdravilo Neoclarityn deluje?
English: These cases were considered serious in all reports.
Slovenian: Ti primeri so bili v vseh poročilih obravnavani kot resni.
English: Some of these events have been reported more than 1-year after initiation of treatment.
Slovenian: O nekaterih izmed teh dogodkov so poročali več kot 1 leto po uvedbi zdravljenja.
English: Prilaz baruna Filipovica 25 10000 Zagreb Croatia
Slovenian: Prilaz baruna Filipovica 25 10000 Zagreb Hrvaška
English: There is no specific antidote.
Slovenian: Specifičen antidot ne obstaja.
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Only single cases of reported cases had not recovered at the time they were reported.
Slovenian: Samo posamezni bolniki izmed poročanih primerov niso okrevali v času poročanja primera.
English: Tell your doctor or pharmacist if you are smoking or intend to stop smoking.
Slovenian: Obvestite zdravnika ali farmacevta, če kadite ali nameravate prenehati kaditi.
English: 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).
Slovenian: 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).
English: Less than 1% of rasagiline is excreted as unchanged product in urine.
Slovenian: Manj kot 1 % razagilina se izloči nespremenjenega z urinom.
English: This leaflet was last revised in MM/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano MM/LLLL.
English: Adverse reactions were mild or moderate and not related to rasagiline treatment.
Slovenian: Neželeni učinki so bili blagi ali zmerni in niso bili povezani z zdravljenjem z razagilinom.
English: Your doctor may need to adjust or stop your dose (see section 4).
Slovenian: Vaš zdravnik vam bo moral morda prilagoditi odmerek ali prekiniti zdravljenje (glejte poglavje 4).
English: Smoking could decrease the amount of Rasagiline ratiopharm in the blood.
Slovenian: Kajenje lahko zmanjša količino zdravila Razagilin ratiopharm v krvi.
English: The absolute bioavailability of a single rasagiline dose is about 36%.
Slovenian: Absolutna biološka uporabnost enkratnega odmerka razagilina je okoli 36 %.
English: 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).
Slovenian: Zbrani podatki nakazujejo, da je Parkinsonova bolezen, ne pa zdravila sama po sebi, povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki ali pretisnem omotu poleg oznake »EXP«.
English: These adverse reactions were not associated with an elevated rate of drug discontinuation.
Slovenian: Ti neželeni učinki niso bili povezani s povišano stopnjo prekinitve zdravljenja.
English: - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Slovenian: - povišan krvni tlak - prekomerna zaspanost - nenadni spanec
English: No change in dose is required for elderly patients (see section 5.2).
Slovenian: Za starejše bolnike ni potrebno spreminjanje odmerka (glejte poglavje 5.2).
English: Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that rasagiline does not affect them adversely.
Slovenian: Bolnike je treba opozoriti, naj ne upravljajo nevarnih strojev, vključno z motornimi vozili, dokler niso ustrezno prepričani, da razagilin na njih ne vpliva škodljivo.
English: Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2)
Slovenian: Starost ima zelo malo vpliva na farmakokinetiko razagilina pri starejših (> 65 let) (glejte poglavje 4.2)
English: 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.
Slovenian: 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.
English: Patients with Parkinson's disease are particularly vulnerable to the adverse reactions of hypotension due to existing gait issues.
Slovenian: Bolniki s Parkinsonovo boleznijo so še posebej ranljivi na neželene učinke hipotenzije zaradi obstoječe problematike s hojo.
English: These symptoms may resemble those observed with nonselective MAO inhibitors.
Slovenian: Ti simptomi so lahko podobni simptomom, ki jih je mogoče opaziti pri neselektivnih inhibitorjih MAO.