FrancophonIA/ELRC3.0 huggingface dataset:
English: VANCOMYCIN HYDROCHLORIDE 500000 I.U.
Croatian: VANCOMYCIN HYDROCHLORIDE 500000 I.U. BOČICA
English: Vancomycin hydrochloride 500 Vial
Croatian: Vancomycin hydrochloride 500 BOČICA
English: Vancomycin Noridem VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Noridem VANCOMYCIN 500MG BOČICA
English: Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG VIAL
Croatian: Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG BOČICA
English: Vancomycin Actavis VANCOMYCIN 1000MG VIAL
Croatian: Vancomycin Actavis VANCOMYCIN 1000MG BOČICA
English: VANCOMYCIN 1G VIAL POWDER FOR
Croatian: VANCOMYCIN POWDER FOR
English: Vankomicin Actavis VANCOMYCIN 500MG VIAL
Croatian: Vankomicin Actavis VANCOMYCIN 500MG BOČICA
English: 1025.2 - 1040.2MG VIAL
Croatian: 1025.14MG BOČICA
English: Vancomycin Actavis VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Actavis VANCOMYCIN 500MG BOČICA
English: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL
Croatian: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG BOČICA
English: Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 500 mg VIAL
Croatian: Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 500 mg BOČICA
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
Croatian: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG BOČICA
English: Vancomycin Hikma VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Hikma VANCOMYCIN 500MG BOČICA
English: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL
Croatian: Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG BOČICA
English: Vancomycin Hikma VANCOMYCIN 1000MG VIAL
Croatian: Vancomycin Hikma VANCOMYCIN 1000MG BOČICA
English: Vancomycine Hikma VANCOMYCIN 500MG VIAL
Croatian: Vancomycine Hikma VANCOMYCIN 500MG BOČICA
English: 1000MG vial
Croatian: 1000MG BOČICA
English: 513MG Vial
Croatian: 513MG BOČICA
English: VANCOMYCIN HYDROCHLORIDE 512MG VIAL
Croatian: VANCOMYCIN HYDROCHLORIDE 512MG BOČICA
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Croatian: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG BOČICA
English: VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL
Croatian: VANCOMYCIN HYDROCHLORIDE 512.57MG BOČICA
English: 500MG VIAL
Croatian: 500MG BOČICA
English: Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg vial
Croatian: Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg BOČICA
English: Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 500 mg vial
Croatian: Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 500 mg BOČICA
English: Vancomycine Hikma VANCOMYCIN 1000MG VIAL
Croatian: Vancomycine Hikma VANCOMYCIN 1000MG BOČICA
English: Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Croatian: Vancomycin Nrim VANCOMYCIN 1000MG BOČICA
English: Vancomycin Nrim VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Nrim VANCOMYCIN 500MG BOČICA
English: Trading
Croatian: Laboratórios
English: Vancomycine Mylan VANCOMYCIN 500MG VIAL
Croatian: Vancomycine Mylan VANCOMYCIN 500MG BOČICA
English: VANCOMYCIN Hydrochloride1000MG VIAL
Croatian: VANCOMYCIN Hydrochloride1000MG BOČICA
English: Vancomycin Mylan VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Mylan VANCOMYCIN 500MG BOČICA
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Croatian: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG BOČICA
English: Vankomicin Pfizer VANCOMYCIN 1000MG VIAL
Croatian: Vankomicin Pfizer VANCOMYCIN 1000MG BOČICA
English: Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG VIAL
Croatian: Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG BOČICA
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Croatian: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG BOČICA
English: POWDER FOR ORAL SOLUTION, SOLUTION FOR INFUSION
Croatian: PRAŠAK ZA ORALNU OTOPINU, SOLUTION FOR INFUSION
English: Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE
Croatian: Sandoz Gmbh Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE
English: Vancomicina Pfizer VANCOMYCIN 1000MG VIAL
Croatian: Vancomicina Pfizer VANCOMYCIN 1000MG BOČICA
English: Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL
Croatian: Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG BOČICA
English: Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL
Croatian: Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG BOČICA
English: Vancomycine Pfizer VANCOMYCIN 500MG VIAL
Croatian: Vancomycine Pfizer VANCOMYCIN 500MG BOČICA
English: Vancomycin Teva VANCOMYCIN 1000 I.U.
Croatian: Vancomycin Teva VANCOMYCIN 1000 I.U. / MG
English: Vancomycin Pfizer VANCOMYCIN 1000MG VIAL
Croatian: Vancomycin Pfizer VANCOMYCIN 1000MG BOČICA
English: Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 1000MG VIAL
Croatian: Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 1000MG BOČICA
English: Vankomicin Pfizer VANCOMYCIN 500MG VIAL
Croatian: Vankomicin Pfizer VANCOMYCIN 500MG BOČICA
English: Vancomicina Pfizer VANCOMYCIN 500MG VIAL
Croatian: Vancomicina Pfizer VANCOMYCIN 500MG BOČICA
English: Vancomicina Labesfal VANCOMYCIN Hydrochloride 500MG vial
Croatian: Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 500MG BOČICA
English: Vancomycin Norma VANCOMYCIN 500MG VIAL
Croatian: Norma Hellas S.A. Vancomycin Norma VANCOMYCIN 500MG BOČICA
English: HYDROCHLORIDE 500MG VIAL
Croatian: HYDROCHLORIDE 500MG BOČICA
English: 512.6 - 520.1MG VIAL
Croatian: 512.571MG UNITS
English: Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 500MG VIAL
Croatian: Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 500MG BOČICA
English: Vancomycin Pfizer VANCOMYCIN 500MG VIAL
Croatian: Vancomycin Pfizer VANCOMYCIN 500MG BOČICA
English: VANCOMYCIN HYDROCHLORIDE 1MG VIAL
Croatian: VANCOMYCIN HYDROCHLORIDE 1MG BOČICA
English: Vancomicina Normon VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Croatian: Vancomicina Normon VANCOMYCIN 1G BOČICA
English: Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G
Croatian: Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G BOČICA
English: VANCOMYCIN HYDROCHLORIDE 510MG VIAL
Croatian: VANCOMYCIN HYDROCHLORIDE 510MG BOČICA
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: The dose in children depends on their age.
Croatian: Doza u djece ovisi o njihovoj dobi.
English: Adults and adolescents can use any form of the medicine.
Croatian: Odrasle osobe i adolescenti mogu koristiti bilo koji oblik lijeka.
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.
Croatian: Cjeloviti EPAR za lijek Neoclarityn nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The side effects seen in children are similar.
Croatian: Kod djece su uočene slične nuspojave.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Neoclarityn na snazi u Europskoj uniji od 15. siječnja 2001.
English: Neoclarityn has also been studied in 416 patients with urticaria.
Croatian: Neoclarityn je također ispitivan u 416 bolesnika s urtikarijom.
English: The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Croatian: Preporučena doza za odrasle osobe i adolescente (u dobi od 12 godina i stariji) iznosi 5 mg jednom na dan.
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.
Croatian: Predstavljena su dodatna ispitivanja kako bi se pokazalo da tijelo tretira sirup, oralnu otopinu i orodisperzibilne tablete na isti način kao tablete, te da bi se dokazalo da se mogu sigurno primjenjivati u djece.
English: In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Croatian: U odraslih osoba i adolescenata, najčešće nuspojave bile su iscrpljenost (umor; 1,2 %), suha usta (0,8 %) i glavobolja (0,6 %).
English: This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Neoclarityn.
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.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Neoclarityn.
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%).
Croatian: U djece mlađe od dvije godine, najčešće nuspojave su proljev (3,7 %), vrućica (2,3 %) i insomnija (poteškoće sa spavanjem; 2,3 %).
English: In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Croatian: U svim ispitivanjima, djelotvornost lijeka Neoclarityn uspoređena je s onom placeba (liječenja bez djelatne tvari).
English: For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Neoclarityn pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Croatian: Ako su receptori inhibirani, histamin ne može djelovati, te to rezultira ublažavanjem simptoma ili alergije.
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.
Croatian: U dva ispitivanja kod urtikarije, smanjenje u rezultatu simptoma nakon šest tjedana terapije lijekom Neoclarityn bilo je 58 do 67 %, u usporedbi sa 40 i 33 % u bolesnika liječenih placebom.
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).
Croatian: Neoclarityn je ispitivan u ukupno osam ispitivanja koja su obuhvatila 4 800 odraslih osoba i adolescenata s alergijskim rinitisom (uključujući ispitivanja u slučaju sezonskog alergijskog rinitisa i dva ispitivanja u bolesnika koji su također imali astmu).
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.
Croatian: Dostupan je kao tablete od 5 mg, orodisperzibilne tablete (tablete koje se otapaju u ustima) od 2,5 mg i 5 mg, sirup od 0,5 mg/ml i oralna otopina od 0,5 mg/ml.
English: Neoclarityn is a medicine containing the active substance desloratadine.
Croatian: Neoclarityn je lijek koji sadrži djelatnu tvar desloratadin.
English: The active substance in Neoclarityn, desloratadine, is an antihistamine.
Croatian: Djelatna tvar lijeka Neoclarityn, desloratadin, je antihistamin.
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.
Croatian: Djelotvornost je mjerena promatranjem promjena simptoma (svrbež, broj i veličina osipa, poremećaji spavanja i dnevnih funkcija) prije i nakon šest tjedana terapije.
English: Other information about Neoclarityn
Croatian: Ostale informacije o lijeku Neoclarityn
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.
Croatian: U slučaju alergijskog rinitisa, promatrajući rezultate svih ispitivanja zajedno, nakon dva tjedna terapije lijekom Neoclarityn od 5 mg došlo je do prosječnog smanjenja simptoma od 25 do 32 %, u usporedbi sa smanjenjem od 12 do 26% u bolesnika koji su primali placebo.
English: EPAR summary for the public desloratadine
Croatian: EPAR, sažetak za javnost
English: Why has Neoclarityn been approved?
Croatian: Zašto je Neoclarityn odobren?
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).
Croatian: Neoclarityn se koristi za ublažavanje simptoma alergijskog rinitisa (upale nosnih putova uzrokovane alergijom, primjerice alergijom na sijeno ili alergijom na prašinske grinje) ili urtikarije (stanje kože uzrokovano alergijom, sa simptomima koji uključuju svrbež i osip).
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Croatian: Djeluje inhibirajući receptore na koje se normalno vezuje histamin, tvar u tijelu koja uzrokuje alergijske simptome.
English: Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Croatian: Neoclarityn se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na desloratadin ili na bilo koju drugu pomoćnu tvar.
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.
Croatian: CHMP je odlučio da koristi lijeka Neoclarityn premašuju s njim povezane rizike za ublažavanje simptoma povezanih s alergijskim rinitisom ili urtikarijom i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
English: What is Neoclarityn?
Croatian: Što je Neoclarityn?
English: What is the risk associated with Neoclarityn?
Croatian: Koji su rizici povezani s lijekom Neoclarityn?
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.
Croatian: Djelotvornost lijeka Neoclarityn mjerena je promatranjem promjena simptoma (iscjedak iz nosa, svrbež, kihanje i zatvor) prije i nakon dva ili četiri tjedna terapije.
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.
Croatian: U djece u dobi od jedne do pet godina, doza od 1,25 mg jednom na dan uzima se kao sirup ili oralna otopina od 2,5 ml.
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.
Croatian: U djece od šest do 11 godina, doza se uzima jednom na dan, i to kao 5 ml sirupa ili oralne otopine ili kao jedna orodisperzibilna tableta od 2,5 mg.
English: What is Neoclarityn used for?
Croatian: Za što se Neoclarityn koristi?
English: For the full list of all side effects reported with Neoclarityn, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Neoclarityn potražite u uputi o lijeku.
English: What benefit has Neoclarityn shown during the studies?
Croatian: Koje su koristi lijeka Neoclarityn utvrđene u ispitivanjima?
English: How is Neoclarityn used?
Croatian: Kako se Neoclarityn koristi?
English: How has Neoclarityn been studied?
Croatian: Kako je Neoclarityn ispitivan?
English: How does Neoclarityn work?
Croatian: Kako djeluje Neoclarityn?
English: Its terminal half-life is 0.6-2 hours.
Croatian: Njegov terminalni poluvijek je 0,6-2 sata.
English: Some of these events have been reported more than 1-year after initiation of treatment.
Croatian: Neki od tih događaja zabilježeni su nakon više od godine dana od početka liječenja.
English: - If you see or hear things which are not there (hallucinations).
Croatian: Ako vidite ili čujete stvari koje nisu stvarne (halucinacije).
English: These cases were considered serious in all reports.
Croatian: Ti su slučajevi u svim prijavama smatrani ozbiljnima.
English: Blisters: 3 years Bottles: 3 years
Croatian: Bočice: 3 godine
English: Contact you doctor right away if you notice any of the following symptoms.
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koji od sljedećih simptoma.
English: - If you have severe liver problems.
Croatian: - ako imate teške probleme s jetrom.
English: Hallucinations*, Abnormal dreams
Croatian: Halucinacije*, Abnormalni snovi
English: Only single cases of reported cases had not recovered at the time they were reported.
Croatian: Samo u pojednim od svih prijavljenih slučajeva nije došlo do oporavka u vrijeme prijave.
English: Tell your doctor or pharmacist if you are smoking or intend to stop smoking.
Croatian: Obavijestite svog liječnika ili ljekarnika ako pušite ili namjeravate prestati pušiti.
English: Less than 1% of rasagiline is excreted as unchanged product in urine.
Croatian: Manje od 1 % razagilina se izlučuje nepromijenjeno u urinu.
English: Take the next dose normally, when it is time to take it.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Croatian: Parkinsonova bolest se povezuje sa simptomima halucinacija i konfuzije.
English: Teva Operations Poland Sp.z o.o.
Croatian: Teva Operations Poland Sp.z o.o. ul.
English: Your doctor may need to adjust or stop your dose (see section 4).
Croatian: Vaš liječnik će možda morati prilagoditi dozu ili prekinuti liječenje (vidjeti dio 4).
English: Smoking could decrease the amount of Rasagiline ratiopharm in the blood.
Croatian: Pušenje može smanjiti količinu Razagilin ratiopharma u krvi.
English: 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.
Croatian: Obratite se svom liječniku prije nego uzmete Razagilin ratiopharm - ako imate bilo kakve probleme s jetrom - morali biste razgovarati sa svojim liječnikom o bilo kakvim sumnjivim promjenama na koži.
English: 4.5 Interaction with other medicinal products and other forms of interaction MAO Inhibitors
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija MAO inhibitori
English: No change in dose is required for elderly patients (see section 5.2).
Croatian: Nije potrebna promjena doze kod starijih bolesnika (vidjeti dio 5.2).
English: It can be used together with or without Levodopa (another medicine that is used to treat Parkinson's disease).
Croatian: Može se primjeniti zajedno s levodopom ili bez levodope (drugi lijek koji se primjenjuje za liječenje Parkinsonove bolesti).
English: Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD02
Croatian: Farmakoterapijska skupina: Antiparkinsonici, inhibitori monoaminooksidaze B, ATK oznaka: N04BD02
English: For further information please refer to section driving and using machines.
Croatian: Za više informacija proučite dio o upravljanju vozilima i radu sa strojevima.
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).
Croatian: Nuspojave su navedene u tablicama 1 i 2 prema klasifikaciji organskih sustava i učestalosti prema sljedećem pravilu: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1 000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1 000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: These symptoms may resemble those observed with nonselective MAO inhibitors.
Croatian: Ovi simptomi mogu nalikovati na one opažene kod neselektivnih MAO inhibitora.
English: Decreasing the dose of levodopa may ameliorate this adverse reaction.
Croatian: Sniženje doze levodope može ublažiti ovu nuspojavu.
English: This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline ratiopharm.
Croatian: To se može pojačati ako uzimate druge lijekove za liječenje simptoma Parkinsonove bolesti ili ako uzimate lijekove koji Vas mogu omamiti ili pijete alkohol dok uzimate Razagilin ratiopharm.
English: - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Croatian: - povišeni krvni tlak - prekomjerna omamljenost - iznenadni nastup sna
English: White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Croatian: Bijele bočice od polietilena visoke gustoće sa ili bez sigurnosnog zatvarača za djecu koje sadržavaju 30 tableta.
English: 12 January 2015
Croatian: Datum prvog odobrenja: 12. siječanj 2015.
English: Skin carcinoma
Croatian: Karcinom kože
English: If you take more Rasagiline ratiopharm than you should If you think that you may have taken too many Rasagiline ratiopharm tablets, contact your doctor or pharmacist immediately.
Croatian: Ako uzmete više Razagilin ratiopharma nego što ste trebali Ako mislite da ste možda uzeli previše Razagilin ratiopharm tableta, odmah se obratite svom liječniku ili ljekarniku.
English: Tyramine/rasagiline interaction
Croatian: Tiramin/razagilin interakcija
English: Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: These results indicate that rasagiline's therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes (see section 5.3).
Croatian: Ovi rezultati indiciraju da nije vjerojatno da terapijske koncentracije razagilina prouzročuju bilo kakvu klinički značajnu interferenciju sa supstratima ovih enzima (vidjeti dio 5.3).
English: Malignant melanoma
Croatian: Maligni melanom
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na reprodukciju (vidjeti dio 5.3).
English: Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2)
Croatian: Dob slabo utječe na farmakokinetiku razagilina u starijih osoba (> 65 godina) (vidjeti dio 4.2).
English: As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu razagilina tijekom trudnoće.
English: Depression, Hallucinations*
Croatian: Depresija Halucinacije*
English: If increased somnolence or new episodes of falling asleep during activities of daily living (e.g. watching television, passenger in a car, etc.) are experienced at any time during treatment, the patients should not drive or participate in potentially dangerous activities.
Croatian: U slučaju povećane somnolencije ili novih epizoda nastupa sna tijekom dnevnih aktivnosti (primjerice, gledanja televizije, vožnje u automobilu kao putnik itd.) bilo kada tijekom liječenja, bolesnik ne smije voziti niti sudjelovati u potencijalno opasnim aktivnostima.
English: Additional cases of malignant melanoma were reported during post-marketing period.
Croatian: Dodatni slučajevi malignog melanoma prijavljeni su tijekom razdoblja nakon stavljanja lijeka u promet.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Croatian: 7 tableta 10 tableta 28 tableta 30 tableta 100 tableta 112 tableta 10 x 1 tableta 30 x 1 tableta 100 x 1 tableta