FrancophonIA/ELRC3.0 huggingface dataset:
English: If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced.
Croatian: Ako je potrebno prekinuti liječenje lijekom Lakozamid Accord, dozu valja postupno smanjivati.
English: As for every medicine, the company provided studies on the quality of Lacosamide Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila studije o kvaliteti lijeka Lakozamid Accord.
English: Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Croatian: To zajedno može smanjiti abnormalnu električnu aktivnost koja se širi kroz mozak te time smanjuje mogućnost epileptičkog napadaja.
English: Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Lakozamid Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je lijek Lakozamid Accord usporediv s lijekom Vimpat.
English: There was no need for ‘bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nije bilo potrebe za ispitivanjima bioekvivalencije kako bi se istražilo apsorbira li se Lakozamid Accord na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek, Vimpat, te ih ne treba ponavljati za lijek Lakozamid Accord.
English: It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Croatian: Može se koristiti za liječenje parcijalnih napadaja sa sekundarnom generalizacijom (naknadno širenje napadaja na druge dijelove mozga) ili bez nje.
English: What measures are being taken to ensure the safe and effective use of Lacosamide Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lakozamid Accord?
English: This is a summary of the European public assessment report (EPAR) for Lacosamide Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Lakozamid Accord.
English: What are the benefits and risks of Lacosamide Accord?
Croatian: Koje su koristi i rizici lijeka Lakozamid Accord?
English: Other information about Lacosamide Accord
Croatian: Ostale informacije o lijeku Lakozamid Accord
English: If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose).
Croatian: ostvariti brži učinak, liječenje lijekom Lakozamid Accord može započeti većom prvom dozom (naziva se udarna doza).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Accord have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Lakozamid Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Lacosamide Accord is given on its own or combined with other medicines for epilepsy.
Croatian: Lakozamid Accord daje se kao monoterapija ili u kombinaciji s drugim lijekovima za epilepsiju.
English: For more information about treatment with Lacosamide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Lakozamid Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Lacosamide Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lakozamid Accord.
English: Why is Lacosamide Accord approved?
Croatian: Zašto je lijek Lakozamid Accord odobren?
English: The Agency recommended that Lacosamide Accord be approved for use in the EU.
Croatian: Agencija je preporučila davanje odobrenja za stavljanje lijeka Lakozamid Accord u promet u EU-u.
English: For practical information about using Lacosamide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Lakozamid Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for Vimpat, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Vimpat.
English: How does Lacosamide Accord work?
Croatian: Kako djeluje Lakozamid Accord?
English: The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine.
Croatian: Djelatna tvar u lijeku Lakozamid Accord, lakozamid, lijek je za epilepsiju.
English: How is Lacosamide Accord used?
Croatian: Kako se Lakozamid Accord koristi?
English: Lacosamide Accord lacosamide
Croatian: Lakozamid Accord lakozamid
English: Lacosamide Accord contains the active substance lacosamide.
Croatian: Lakozamid Accord sadržava djelatnu tvar lakozamid.
English: How has Lacosamide Accord been studied?
Croatian: Kako je Lakozamid Accord ispitivan?
English: This summary was last updated in 09-2017.
Croatian: Lakozamid Accord EMA/536300/2017
English: These reactions may be severe.
Croatian: Te reakcije mogu biti teške.
English: In children this may affect growth and development.
Croatian: U djece može utjecati na rast i razvoj.
English: You should avoid coming into contact with anyone who has these infections.
Croatian: Trebate izbjegavati kontakt sa svakom osobom koja ima te infekcije.
English: This medicine has been prescribed for you.
Croatian: - Ovaj je lijek propisan samo Vama.
English: if you have cystic fibrosis.
Croatian: • Ako imate cističnu fibrozu.
English: if you are using the medicine for several months or longer.
Croatian: • Ako primjenjujete ovaj lijek nekoliko mjeseci ili dulje.
English: No interactions were observed.
Croatian: Interakcije nisu zabilježene.
English: if you have any other infection.
Croatian: • Ako imate neku drugu infekciju.
English: The median (50%) onset time of relief was 35.9 hours.
Croatian: Medijan (50%) otklanjanja simptoma bilo je 35,9 sati.
English: Breathe out through your mouth.
Croatian: Izdahnite kroz usta.
English: It is important to clean your nasal spray regularly, otherwise it may not work properly.
Croatian: • Važno je da redovito čistite svoj sprej za nos, u protivnom možda neće ispravno raditi.
English: Most people do not have any problems after using the nasal spray.
Croatian: Većina ljudi nema nikakvih problema nakon korištenja spreja za nos.
English: It is very important that you use your nasal spray regularly.
Croatian: Vrlo je važno da redovito koristite svoj sprej za nos.
English: Always use Nasonex exactly as your doctor has told you.
Croatian: Uvijek primijenite Nasonex točno onako kako Vam je rekao liječnik.
English: Repeat steps 3 to 6 for the other nostril (Figure 3).
Croatian: Ponovite korake od 3 do 6 za drugu nosnicu (Slika 3).
English: Please read this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati lijek jer sadrži Vama važne podatke.
English: Shake gently before use.
Croatian: Nježno protresti prije uporabe.
English: Disturbances of taste and smell
Croatian: poremećaji osjeta okusa i mirisa
English: Effect on Growth in Paediatric Population
Croatian: Utjecaj na rast u pedijatrijskoj populaciji
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (učestalost se ne može ustanoviti iz dostupnih podataka):
English: There was no effect on fertility.
Croatian: Nije bilo učinka na plodnost.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: None known.
Croatian: Nije poznat.
English: A clinical interaction study was conducted with loratadine.
Croatian: Provedeno je kliničko ispitivanje interakcije s loratadinom.
English: Do not use a larger dose or use the spray more often or for longer than your doctor tells you to.
Croatian: Nemojte koristiti lijek u većim količinama ili češće ili duže od onoga kako Vam je rekao liječnik.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Croatian: Učestalosti su definirane kao: vrlo česte (≥ 1/10), česte (≥ /100 i < 1/10), manje česte (≥ 1/1000 i < 1/100).
English: You should stop taking Nasonex and get immediate medical help if you experience symptoms such as:
Croatian: Morate prestati primjenjivati Nasonex i odmah potražiti liječničku pomoć ako osjetite sljedeće simptome, kao što su:
English: In addition, consideration should be given to referring the patient to a paediatric specialist.
Croatian: Osim toga, potrebno je razmotriti upućivanje bolesnika pedijatru.
English: if you have recently had an operation on your nose or you have injured your nose.
Croatian: • ako ste nedavno imali operaciju ili ozljedu nosa.
English: Systemic Effects of Corticosteroids
Croatian: Sistemski učinci kortikosteroida
English: Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.
Croatian: • Nemojte pokušavati deblokirati nosni aplikator umetanjem igle ili drugog oštrog predmeta jer će to oštetiti aplikator i dovesti do toga da nećete dobiti ispravnu dozu lijeka.
English: • Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated.
Croatian: Unilateralne polipe koji su neobičnog ili nepravilnog izgleda potrebno je dodatno evaluirati, osobito ukoliko su ulcerirani ili krvare.
English: Do not stop your treatment even if you feel better unless told to do so by your doctor.
Croatian: Ukoliko se osjećate bolje nemojte prekinuti liječenje, osim ukoliko Vam to nije rekao Vaš liječnik.
English: Gently shake the bottle.
Croatian: Nježno protresite bocu.
English: Nasonex is not recommended in case of nasal septum perforation (see section 4.8).
Croatian: NASONEX se ne preporučuje u slučaju perforacije nosnog septuma (vidjeti dio 4.8).
English: If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Croatian: Ako postoje dokazi o primjeni doza viših od preporučenih, onda je potrebno razmotriti dodatnu primjenu sistemskih kortikosteroida tijekom razdoblja stresa ili elektivnog kirurškog zahvata.
English: All observed effects are typical of this class of compounds and are related to exaggerated pharmacologic effects of glucocorticoids.
Croatian: Svi primijećeni učinci su tipični za tu klasu djelatnih tvari i povezani su s prekomjernim farmakološkim učincima glukokortikosteroida.
English: White to off-white opaque suspension.
Croatian: Bijela ili gotovo bijela neprozirna suspenzija.
English: Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis.
Croatian: Epistaksa je općenito bila samoograničavajuća i blage naravi, a javljala se u većoj incidenciji nego kod primjene placeba (5%), ali u usporedivoj ili nižoj incidenciji u usporedbi s nazalnim kortikosteroidima koji su bili aktivna kontrola u ispitivanju (do 15%) kao što je prijavljeno u kliničkim ispitivanjima za alergijski rinitis.
English: if you have an infection of the nose or throat.
Croatian: • Ako imate infekciju nosa ili grla.
English: Immediate hypersensitivity (allergic) reactions may occur after use of this product.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) mogu se javiti odmah nakon primjene ovog lijeka.
English: Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids, ATC code: R01A D09
Croatian: Farmakoterapijska skupina: nazalni dekongestivi za lokalnu primjenu - kortikosteroidi, ATK oznaka: R01A D09.
English: In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Croatian: Dodatno, on je ekstremno potentan inhibitor proizvodnje Th2 citokina, IL-4 i IL-5 iz humanih CD4+ T-stanica.
English: The incidence of all other adverse events was comparable with that of placebo.
Croatian: Incidencija svih ostalih štetnih događaja može se usporediti s onom kod primjene placeba.
English: Repeat step 4 to inhale a second spray in the same nostril if applicable.
Croatian: Ponovite korak 4 kako biste udahnuli drugi uštrcaj u istu nosnicu, ako je primjenjivo.
English: Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
Croatian: Neklinička ispitivanja pokazuju da mometazonfuroat nema androgeni, antiandrogeni, estrogeni ili antiestrogeni učinak, ali poput ostalih glukokortkosteroida pokazuje antiuterotropsko djelovanje i odgađa vaginalno otvaranje na životinjskim modelima u visokim peroralnim dozama od 56 mg/kg/dan i 280 mg/kg/dan.
English: These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Croatian: Vjerojatnost nastanka tih učinaka puno je manja nego kod oralnih kortikosteroida i može varirati u pojedinih bolesnika i između različitih kortikosteroidnih pripravaka.
English: If you use more Nasonex than you should
Croatian: Ako primijenite više lijeka Nasonex nego što ste trebali
English: The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant) at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.
Croatian: Kancerogeni potencijal inhaliranog mometazonfuroata (aerosol s CFC propelentom i surfaktantom) u koncentracijama od 0,25 do 2,0 mikrograma/l ispitivan je u 24-mjesečnom ispitivanju na miševima i štakorima.
English: Animal studies have shown reproductive toxicity, but no effects on fertility (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost, ali ne i učinke na plodnost (vidjeti dio 5.3).
English: 140 actuations
Croatian: 140 uštrcaja
English: It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions.
Croatian: Vjerojatno je većinski mehanizam antialergijskih i protuupalnih učinaka mometazonfuroata njegova sposobnost inhibicije otpuštanja medijatora alergijske reakcije.
English: if you have an untreated infection in your nose.
Croatian: • ako imate neliječenu infekciju u nosu.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Croatian: Dozu treba istitrirati na najmanju dozu pri kojoj će se održati učinkovita kontrola simptoma.
English: In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Croatian: U pedijatrijskoj populaciji, incidencija zabilježenih štetnih događaja u kliničkim ispitivanjima, npr. epistakse (6%), glavobolje (3%), iritacije nosa (2%) i kihanja (2%) bila je usporediva s placebom.
English: There are no clinical data concerning the effect of mometasone furoate on fertility.
Croatian: Nema kliničkih podataka o učinku mometazonfuroata na plodnost.
English: Epistaxis was generally self-limiting and mild in severity (see section 4.8).
Croatian: Epistaksa je općenito bila samoograničavajuća i blage naravi (vidjeti dio 4.8).
English: At the end of the pollen season your hayfever symptoms should get better and treatment may then not be needed.
Croatian: Na kraju sezone cvjetanja simptomi peludne groznice bi se trebali poboljšati te tada liječenje možda neće biti potrebno.
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Croatian: Mometazonfuroat je glukokortikosteroid za lokalnu primjenu koji ima lokalna protuupalna svojstva pri dozama koje nisu sistemski aktivne.
English: If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Croatian: Ukoliko je rast usporen, terapija se mora razmotriti s ciljem smanjenja doze nazalnih kortikosteroida, ukoliko je to moguće, na najnižu dozu kojom se postiže učinkovita kontrola simptoma.
English: • Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza
English: Nasal Spray, Suspension.
Croatian: OBLIK Sprej za nos, suspenzija.
English: This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.
Croatian: Ovaj lijek sadrži 0,02 mg benzalkonijevog klorida po uštrcaju.
English: In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a potent inhibitor of leukotriene production.
Croatian: Mometazonfuroat se u staničnoj kulturi pokazao visoko potentnim u inhibiciji sinteze i otpuštanja IL-1, IL-5, IL-6 i TNFα; također je potentni inhibitor proizvodnje leukotriena.
English: In a study involving 48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200 µg/day for 14 days, there was no significant differences from placebo in the mean change in plasma cortisol level in response to the tetracosactrin stimulation test.
Croatian: U ispitivanju u koje je bilo uključeno 48 djece u dobi od 3 do 5 godina koja su liječena intranazalnim mometazonfuroatom 50, 100 ili 200 mikrograma/dan tijekom 14 dana, nije bilo značajnih razlika u srednjim vrijednostima razine kortizola u plazmi u odnosu na placebo prema odgovoru na tetrakozaktrin stimulirajući test.
English: As with other nasal corticosteroid preparations, NASONEX Nasal Spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant.
Croatian: Kao i s drugim nazalnim kortikosteroidnim pripravcima, NASONEX sprej za nos se ne smije primjenjivati u trudnica osim ako potencijalna korist za majku opravdava potencijalni rizik za majku, fetus ili dojenče.
English: Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle.
Croatian: Stavite mlaznicu između svog kažiprsta i srednjeg prsta, a palac ispod boce.
English: No statistically significant dose-response relationship was detected for any of the tumour types.
Croatian: Nije otkriven statistički značajan odgovor ovisan o dozi za bilo koji tip tumora.
English: If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
Croatian: Ako takvi bolesnici pokažu znakove i simptome adrenalne insuficijencije ili simptome ustezanja (npr. bol u zglobovima i/ili mišićima, klonulost i depresiju u početku) usprkos ublažavanju nazalnih simptoma, mora se nastaviti sa sistemskom primjenom kortikosteroida i uvesti druge načine liječenja i odgovarajuće mjere.
English: Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients.
Croatian: Mometazonfuroat značajno inhibira otpuštanje leukotriena iz leukocita alergičnog bolesnika.
English: if you are taking other corticosteroid medicines, either by mouth or by injection.
Croatian: • Ako uzimate neke druge kortikosteroide, bilo da ih uzimate na usta ili putem injekcije.
English: Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Croatian: Dojenčad majki koje su dobivale kortikosteroide u trudnoći potrebno je pomno nadzirati zbog hipoadrenalizma.
English: If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your doctor may advise you to stop taking them once you begin using Nasonex.
Croatian: Ukoliko uzimate druge kortikosteroidne lijekove za alergiju, bilo na usta ili putem injekcije, Vaš liječnik Vam može savjetovati da ih prestanete uzimati nakon što ste počeli primjenjivati Nasonex.
English: • The active substance is mometasone furoate.
Croatian: • Djelatna tvar je mometazonfuroat.
English: In clinical studies, epistaxis occurred at a higher incidence compared to placebo.
Croatian: U kliničkim je ispitivanjima incidencija epistakse bila viša u usporedbi s placebom.
English: Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Croatian: Bolesnici koji primaju kortikosteroide i koji su potencijalno imunosuprimirani, moraju biti upozoreni na rizik od izlaganja određenim infekcijama (npr. vodenim kozicama, ospicama) i da, u slučaju takve izloženosti, potraže medicinski savjet.
English: However, no mutagenic effects can be expected at therapeutically relevant doses.
Croatian: Međutim, u terapijski relevantnim dozama ne očekuju se mutageni učinci.
English: Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function.
Croatian: Ukidanje sistemskih kortikosteroida u tih bolesnika može dovesti do adrenalne insuficijencije tijekom nekoliko mjeseci dok se ne uspostavi funkcija HHA osi.
English: Treatment with higher than recommended doses may result in clinically significant adrenal suppression.
Croatian: Liječenje višim dozama od preporučenih može dovesti do klinički značajne supresije nadbubrežne žlijezde.
English: Because the systemic bioavailability of NASONEX Nasal Spray is <1%, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Croatian: Kako je sistemska bioraspoloživost NASONEX spreja za nos < 1%, nije vjerojatno da će predoziranje zahtijevati bilo koju drugu terapiju osim opservacije, nakon čega slijedi uvođenje odgovarajućeg propisanog doziranja.
English: Perennial rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods.
Croatian: Cjelogodišnji rinitis javlja se tijekom cijele godine te simptomi mogu biti uzrokovani preosjetljivošću na različite stvari poput grinja iz kućne prašine, životinjske dlake (ili peruti), perja ili određenu hranu.