FrancophonIA/ELRC3.0 huggingface dataset:
English: Talmanco is used in patients with class-II (slight limitation of physical activity) or class-III (marked limitation of physical activity) PAH.
Croatian: Talmanco se primjenjuje u liječenju bolesnika s PAH-om II. funkcionalnog stupnja (s blagim ograničenjem tjelesne aktivnosti) ili III. funkcionalnog stupnja (sa značajnim ograničenjem tjelesne aktivnosti).
English: Therefore, the CHMP's view was that, as for Adcirca, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje utvrđeni rizik, kao i kod lijeka Adcirca.
English: For practical information about using Talmanco, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Talmanco bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: For more information about treatment with Talmanco, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Talmanco pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: How is Talmanco used?
Croatian: Kako se Talmanco koristi?
English: How does Talmanco work?
Croatian: Kako djeluje Talmanco?
English: How has Talmanco been studied?
Croatian: Kako je lijek Talmanco ispitivan?
English: This can result in serious vision loss and even blindness.
Croatian: Ovo može rezultirati ozbiljnim gubitkom vida te čak sljepoćom.
English: Simbrinza must not be used in neonates or children under the age of two years and is not recommended in older children.
Croatian: Simbrinza ne smije se primjenjivati u nedonoščadi ili djece mlađe od dvije godine i ne preporučuje se u starije djece.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simbrinza on 18 July 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Simbrinza vrijedi na prostoru Europske unije od 18. srpnja 2014.
English: If other eye drops are also being used to lower eye pressure, they should be given at least 5 minutes apart.
Croatian: Ako se koriste i druge kapi za oči za snižavanje očnoga tlaka, iste se moraju primjenjivati u razmaku od najmanje 5 minuta.
English: The full EPAR and risk management plan summary for Simbrinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Simbrinza nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Simbrinza is given as one drop into the affected eye(s) twice a day.
Croatian: Simbrinza se primjenjuje kao jedna kap u oboljelo(e) oko(oči) dva puta na dan.
English: What is Simbrinza and what is it used for?
Croatian: Što je Simbrinza i za što se koristi?
English: Brimonidine also increases the drainage of aqueous humour from the front of the eye.
Croatian: Brimonidin također povećava drenažu vodenog humora iz prednjeg dijela oka.
English: Both medicines have been used separately to reduce eye pressure for several years in the EU and their combination reduces the pressure inside the eye more effectively than either medicine alone.
Croatian: Oba su lijeka korištena zasebno za snižavanje očnoga tlaka tijekom nekoliko godina u EU, te njihove kombinacije snižavaju tlak unutar oka učinkovitije od monoterapija drugim lijekovima.
English: It is not intended to provide practical advice on how to use Simbrinza.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Simbrinza.
English: What measures are being taken to ensure the safe and effective use of Simbrinza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Simbrinza?
English: This is a summary of the European public assessment report (EPAR) for Simbrinza.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Simbrinza.
English: Simbrinza brinzolamide / brimonidine tartrate
Croatian: Simbrinza brinzolamid / brimonidin tartrat
English: Simbrinza was shown to be as effective as the combination treatment.
Croatian: Simbrinza se pokazao djelotvornim kao kombinirano liječenje.
English: Simbrinza is used when treatment with other medicines containing only one active substance have been tried but has not reduced the intra-ocular pressure sufficiently.
Croatian: Simbrinza se koristi u slučajevima kada je liječenje drugim lijekovima koji sadrže samo jednu djelatnu tvar isprobano, no nije snizilo intraokularni tlak u dostatnoj mjeri.
English: A risk management plan has been developed to ensure that Simbrinza is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Simbrinza.
English: The CHMP therefore concluded that Simbrinza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: CHMP je stoga zaključio da koristi lijeka Simbrinza nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u EU- u.
English: Other information about Simbrinza
Croatian: Ostale informacije o lijeku Simbrinza
English: Open-angle glaucoma (a condition where the aqueous humour, the watery fluid inside the eyeball, cannot drain away properly) and other causes of high pressure in the eye increase the risk of damage to the retina and the optic nerve (the nerve that sends signals from the eye to the brain).
Croatian: Glaukom otvorenog kuta (stanje u kojem vodeni humor, vodenasta tekućina unutar očne jabučice, ne može ispravno iscuriti) i ostali uzroci visokog tlaka u oku povećavaju rizik od oštećenja mrežnice i optičkog živca (živca koji šalje signale iz oka u mozak).
English: Brinzolamide works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate needed for the production of the aqueous humour, while brimonidine tartrate blocks another enzyme known as adenylate cyclase, which is also involved in the production of the aqueous humour.
Croatian: Brinzolamid djeluje inhibirajući enzim karbonatna anhidraza, koji proizvodi bikarbonat potreban za proizvodnju vodenog humora, dok brimonidin tartrat inhibira drugi enzim poznat pod nazivom adenilat ciklaza, koji je također uključen u proizvodnju vodenog humora.
English: The most common side effects in studies with Simbrinza were ocular hyperaemia (red eye) and allergic reactions in the eye, which occurred in about 6 to 7% of patients, and dysgeusia (taste disturbances) in about 3% of patients.
Croatian: Najčešće nuspojave u ispitivanjima lijeka Simbrinza bile su okularna hiperaremija (crveno oko) i alergijske reakcije u oku, koje su se pojavile u otprilike 6 do 7% bolesnika, i disgezija (poremećaji okusa) kod otprilike 3% bolesnika.
English: It will also benefit those patients who need a combination treatment and for whom previously authorised combinations containing the medicine timolol are not suitable.
Croatian: Nadalje, od ovog lijeka imati će koristi i bolesnici kojima je potrebno kombinirano liječenje te za koje nisu primjerene prethodno odobrene kombinacije koje sadrže timolol.
English: The average reduction in intra-ocular pressure with Simbrinza after 3 months was 8.5 mmHg compared with 8.3 mmHg with the combination.
Croatian: Prosječno smanjenje intraokularnog tlaka s lijekom Simbrinza nakon 3 mjeseca iznosilo je 8,5 mmHg u usporedbi s 8.3 mmHg u slučaju kombinacije.
English: What are the risks associated with Simbrinza?
Croatian: Koji su rizici povezani s lijekom Simbrinza?
English: One main study involved 560 patients with ocular hypertension or open-angle glaucoma, whose average intra-ocular pressure before treatment, measured in units called mmHg, was 26 mmHg.
Croatian: Jedno glavno ispitivanje obuhvatilo je 560 bolesnika s okularnom hipertenzijom ili glaukomom otvorenog kuta, čiji je prosječan intraokularan tlak izmjeren prije liječenja u jedinicama naziva mmHg, iznosio 26 mmHg.
English: Why is Simbrinza approved?
Croatian: Zašto je lijek Simbrinza odobren?
English: The active substances in Simbrinza, brinzolamide and brimonidine tartrate, help to reduce intra-ocular pressure by reducing the production of aqueous humour.
Croatian: Djelatne tvari lijeka Simbrinza, brinzolamid i brimonidin tartrat, pomažu u snižavanju intraokularnog tlaka smanjujući proizvodnju vodenog humora.
English: Simbrinza can only be obtained by prescription.
Croatian: Simbrinza se izdaje samo na liječnički recept.
English: It must also not be used in patients receiving certain types of antidepressants, patients with severely reduced kidney function, or in patients with hyperchloraemic acidosis (excess acid in the blood caused by too much chloride).
Croatian: Ne smije se primjenjivati u bolesnika koji primaju određene vrste antidepresiva, bolesnika s ozbiljnim smanjenjem funkcije bubrega, ili u bolesnika s hiperkloremijskom acidozom (prekomjernom kiselinom u krvi uzrokovanom prevelikom količinom klorida).
English: The reduction in intra-ocular pressure after 3 months was greater in patients using Simbrinza (an average fall of 7.9 mmHg) than in those using either brinzolamide or brimonidine tartrate (6.5 and 6.4 mmHg, respectively).
Croatian: Sniženje intraokularnog tlaka nakon 3 mjeseca bilo je veće u bolesnika koji su koristili lijek Simbrinza (prosječno smanjenje od 7,9 mmHg) u odnosu na one koji su koristili monoterapiju brinzolamidom ili brimonidin tartratom (6,5 odnosno 6,4 mmHg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Simbrinza, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Simbrinza uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Simbrinza was shown to be more effective than either active substance used alone and at least as effective as the combination of the active substances given as separate eye drops.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da se Simbrinza pokazao djelotvornijim od monoterapija bilo kojom djelatnom tvari te barem podjednako djelotvoran kao kombinacija djelatnih tvari koje se primjenjuju kao zasebne kapi za oči.
English: Simbrinza must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, or to sulphonamides (a class of antibiotics).
Croatian: Simbrinza se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatne tvari, bilo koju pomoćnu tvar ili na sulfonamide (kategoriju antibiotika).
English: Simbrinza is an eye drop solution that contains two active substances: brinzolamide and brimonidine tartrate.
Croatian: Simbrinza je otopina za kapi za oko koja sadrži dvije djelatne tvari: brinzolamid i brimonidin tartrat.
English: Simbrinza is used to reduce intra-ocular pressure (pressure inside the eye) in adults with ocular hypertension (high intra-ocular pressure) or in those with an eye condition known as open-angle glaucoma.
Croatian: Simbrinza se koristi za smanjivanje intraokularnog tlaka (tlaka unutar oka) u odraslih osoba s okularnom hipertenzijom (visokim intraokularnim tlakom) ili u osoba s očnim stanjem poznatim kao glaukom otvorenog kuta.
English: For more information about treatment with Simbrinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Simbrinza pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: As regards safety, the side effects reported with Simbrinza were what would be expected with the individual active substances and raised no major concerns.
Croatian: Vezano uz sigurnost, prijavljene nuspojave lijeka Simbrinza bile su jednake očekivanima s pojedinačnim djelatnim tvarima te nisu uzrokovale veće zabrinutosti.
English: Having the two active substances in one eye drop will improve convenience and adherence to treatment for patients who are not adequately controlled with either brimonidine or brinzolamide alone.
Croatian: Dvije djelatne tvari u samo jednoj kapi za oči poboljšat će praktičnost i omogućiti da se pacijenti pridržavaju terapije posebice oni koji nisu dosljedno pod kontrolom monoterapijom brimonidinom ili brinzolamidom.
English: A second main study involving 890 patients compared Simbrinza with a combination treatment of brinzolamide and brimonidine tartrate given as separate drops.
Croatian: Drugo glavno ispitivanje obuhvatilo je 890 bolesnika te je usporedilo lijek Simbrinza s kombiniranim liječenjem brinzolamidom i brimonidin tartratom primijenjenim u zasebnim kapima.
English: What benefits of Simbrinza have been shown in studies?
Croatian: Koje su koristi lijeka Simbrinza dokazane u ispitivanjima?
English: For practical information about using Simbrinza, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Simbrinza pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Simbrinza used?
Croatian: Kako se Simbrinza koristi?
English: How does Simbrinza work?
Croatian: Kako djeluje Simbrinza?
English: Simbrinza has been shown to be more effective in reducing eye pressure than either brinzolamide or brimonidine tartrate used alone.
Croatian: Lijek Simbrinza pokazao se djelotvornijim u snižavanju očnoga tlaka od monoterapije brinzolamidom ili brimonidin tartratom.
English: For the full list of all side effects reported with Simbrinza, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Simbrinza, potražite u uputi o lijeku.
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, ali nije moguće dati preporuku o doziranju.
English: The safety profile in these studies was overall comparable to that seen in adults.
Croatian: Sigurnosni profil u ovim ispitivanjima općenito je bio usporediv s onim u odraslih.
English: Some patients required hospitalisation for additional management and some had complications.
Croatian: Nekim je bolesnicima bila potrebna hospitalizacija radi daljnjeg liječenja, a neki su imali komplikacije.
English: ATC code: J05AR15
Croatian: ATK oznaka: J05AR15
English: If you stop taking EVOTAZ Do not stop taking EVOTAZ before talking to your doctor.
Croatian: Ako prestanete uzimati EVOTAZ Nemojte prestati uzimati EVOTAZ prije nego što o tome razgovarate sa svojim liječnikom.
English: Effects unknown
Croatian: Učinci su nepoznati
English: Swallow the tablet whole; do not crush or chew the tablets.
Croatian: Tabletu progutajte cijelu; nemojte lomiti ili žvakati tablete.
English: Wait and take the next dose at the usual time.
Croatian: Pričekajte i uzmite sljedeću dozu prema uobičajenom rasporedu.
English: Do not give this medicine to children and adolescents under 18 years of age.
Croatian: Ovaj se lijek ne smije davati djeci ni adolescentima mlađima od 18 godina.
English: What EVOTAZ is and what it is used for 2.
Croatian: Što je EVOTAZ i za što se koristi 2.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Obično su takve reakcije opažene tijekom prvih nekoliko tjedana ili mjeseci nakon uvođenja CART-a.
English: The mechanism of interaction is unknown.
Croatian: Mehanizam interakcije nije poznat.
English: EU/1/15/1025/001 30 film-coated tablets EU/1/15/1025/002 90 (3 bottles of 30) film-coated tablets
Croatian: EU/1/15/1025/001 30 filmom obloženih tableta EU/1/15/1025/002 90 (3 boce s 30) filmom obloženih tableta
English: If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2015
Croatian: Datum prvog odobrenja: 13.srpnja 2015.
English: Your doctor will discuss the potential benefits and risks of taking EVOTAZ to you and your child.
Croatian: Vaš će liječnik razgovarati s Vama o mogućim koristima i rizicima primjene lijeka EVOTAZ za Vas i Vaše dijete.
English: The lowest dose of digoxin should initially be prescribed.
Croatian: Na početku treba propisati najnižu dozu digoksina.
English: You may continue to develop infections or other illnesses linked to HIV infection.
Croatian: I dalje se mogu razvijati infekcije ili druge bolesti povezane s HIV infekcijom.
English: In the prepartum period, additional monitoring should be considered.
Croatian: Treba razmotriti dodatan nadzor u prepartalnom razdoblju.
English: It is recommended that the INR (International Normalized Ratio) be monitored.
Croatian: Preporučuje se nadzirati INR (internacionalni normalizirani omjer).
English: An initial dose reduction of diltiazem by 50% should be considered, and electrocardiogram monitoring is recommended.
Croatian: Treba razmotriti početno smanjenje doze diltiazema za 50%, a preporučuje se i elektrokardiografsko praćenje.
English: If you take more EVOTAZ than you should
Croatian: Ako uzmete više lijeka EVOTAZ nego što ste trebali
English: Your doctor will discuss with you which combination of these medicines with EVOTAZ is best for you.
Croatian: Liječnik će razgovarati s Vama o tome koja je kombinacija tih lijekova s lijekom EVOTAZ najbolja za Vas.
English: The use of EVOTAZ should only be considered during pregnancy if the potential benefit justifies the potential risk.
Croatian: Primjena lijeka EVOTAZ smije se razmotriti tijekom trudnoće samo ako moguća korist opravdava mogući rizik.
English: The safety and efficacy of EVOTAZ in children less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka EVOTAZ u djece mlađe od 18 godina nisu ustanovljene.
English: Talk to your doctor or pharmacist before taking EVOTAZ.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete EVOTAZ.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da ti simptomi nastaju zbog poboljšanja imunog odgovora tijela, koji tijelu omogućuje da se bori protiv infekcija koje su možda bile prisutne bez očitih simptoma.
English: Electrocardiogram monitoring is recommended.
Croatian: Preporučuje se elektrokardiografsko praćenje.
English: Some people will need special care before or while taking EVOTAZ.
Croatian: Nekim će osobama trebati posebna skrb prije ili tijekom uzimanja lijeka EVOTAZ.
English: It is normally used in combination with other anti-HIV medicines to help control your HIV infection.
Croatian: Obično se uzima u kombinaciji s drugim lijekovima za liječenje HIV infekcije kako bi se pomoglo kontrolirati Vašu HIV infekciju.
English: b See section Description of selected adverse reactions for more details.
Croatian: b Vidjeti 'Opis odabranih nuspojava' za više informacija.
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Croatian: U više od polovice prijavljenih slučajeva, liječenje inhibitorima proteaze se nastavilo ili ponovno uvelo ako je bilo prekinuto.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Croatian: Treba razmotriti prilagodbu doze midazolama, osobito ako se primjenjuje više od jedne doze midazolama.
English: You must not take EVOTAZ with certain medicines.
Croatian: Ne smijete uzimati EVOTAZ s određenim lijekovima.
English: Treatment should consist of general supportive measures including monitoring of vital signs and ECG as well as observation of the patient's clinical status.
Croatian: Liječenje treba uključivati opće suportivne mjere, uključujući praćenje vitalnih znakova i EKG, ali i promatranje kliničkog statusa bolesnika.
English: Do not double the next dose.
Croatian: Nemojte uzeti dvostruku dozu.
English: What EVOTAZ is and what it is used for
Croatian: Što je EVOTAZ i za što se koristi
English: The best results in managing these events come from early diagnosis and immediate interruption of any suspect medicines.
Croatian: Najbolji rezultati u liječenju tih promjena postižu se ranom dijagnozom i trenutačnim prekidom primjene svakog sumnjivog lijeka.
English: To enhance bioavailability, EVOTAZ is to be taken with food.
Croatian: Da bi se povećala bioraspoloživost, EVOTAZ treba uzimati s hranom.
English: If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor.
Croatian: Ako primijetite promjenu u načinu na koji Vam srce kuca (promjene srčanog ritma), obavijestite o tome svog liječnika.
English: What EVOTAZ contains
Croatian: Što EVOTAZ sadrži
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide, u nekim slučajevima postoji dokaz o učinku liječenja, dok za delbljanje nema čvrstog dokaza povezanosti s bilo kojim posebnim liječenjem.
English: CCR5 Antagonists
Croatian: Antagonisti CCR5
English: The film-coated tablet should be swallowed whole and must not be chewed, broken, cut or crushed.
Croatian: Filmom obložena tableta mora se progutati cijela te se ne smije se žvakati, lomiti, rezati ni drobiti.
English: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italy
Croatian: FONTANA DEL CERASO, ANAGNI, 03012, Italija
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the HIV-virus developing resistance to the treatment.
Croatian: Na taj ćete način biti sigurni da je lijek potpuno učinkovit i smanjiti rizik od razvoja otpornosti HIV-virusa na liječenje.
English: Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: Bolesnike treba upozoriti na znakove i simptome i pažljivo ih nadzirati zbog mogućih kožnih reakcija.
English: If you forget to take EVOTAZ
Croatian: Ako ste zaboravili uzeti EVOTAZ
English: Other medicines and EVOTAZ
Croatian: Drugi lijekovi i EVOTAZ
English: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Croatian: Preporuča se da žene zaražene HIV-om ne doje jer se virus može prenijeti preko mlijeka.
English: You can still pass on HIV to other people when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: HIV možete prenijeti na druge ljude čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: A dose reduction of buprenorphine may be considered.
Croatian: Može se razmotriti smanjenje doze buprenorfina.
English: EVOTAZ has no or negligible influence on the ability to drive or use machines.
Croatian: EVOTAZ ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative toxicity of atazanavir.
Croatian: Umjerena količina podataka prikupljenih u trudnica (između 300 i 1000 ishoda trudnoća) ne ukazuje ni na kakve toksične malformacijske učinke atazanavira.
English: There are other medicines that may not be taken together or may require a change in their mode of administration when taken with EVOTAZ.
Croatian: Postoje i drugi lijekovi koji se ne smiju uzimati zajedno ili zahtjevaju promjenu u njihovom načinu primjene kada se uzimaju s lijekom EVOTAZ.