FrancophonIA/ELRC3.0 huggingface dataset:
English: - In patients with moderate renal impairment that have GFR ≥ 30 to < 45 mL/min, in the absence of other conditions that may increase the risk of lactic acidosis, the dose is 2.5 mg/1000 mg or 2.5 mg/850 mg once daily.
Croatian: Bubrežna funkcija Budući da se metformin izlučuje putem bubrega, bubrežnu funkciju treba procijeniti: - prije početka liječenja i redovito nakon toga (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2). - barem 2 do 4 puta godišnje u bolesnika čija je razina brzine glomerularne filtracije (GFR) blizu razine umjerenog oštećenja funkcije, te u starijih bolesnika. - u bolesnika s umjerenim oštećenjem funkcije bubrega, koji imaju GFR ≥ 30 to < 45 ml/min, kada nisu prisutna druga stanja koja mogu povećati rizik od laktacidoze, doza je 2,5 mg/1000 mg ili 2,5 mg/850 mg jedanput dnevno.
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin hydrochloride
Croatian: Komboglyze 2,5 mg/1000 mg filmom obložene tablete saksagliptin/metforminklorid
English: Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Croatian: Komboglyze 2,5 mg/850 mg filmom obložene tablete Svijetlosmeđe do smeđe, bikonveksne, okrugle, filmom obložene tablete koje imaju plavom tintom otisnutu oznaku „2.5/850“ na jednoj i „4246“ na drugoj strani.
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Croatian: U šest dvostruko slijepih, kontroliranih kliničkih ispitivanja sigurnosti i djelotvornosti, provedenih kako bi se ispitali učinci saksagliptina na kontrolu glikemije, randomizirano je 4148 bolesnika sa šećernom bolešću tipa 2, uključujući 3021 bolesnika liječenog saksagliptinom.
English: This summary was last updated in 08-2013.
Croatian: Sažetak je posljednji put obnovljen 08. 2013.
English: Zonegran zonisamide
Croatian: Zonegran zonisamid
English: It is available as capsules (25, 50 and 100 mg) and orodispersible tablets (25, 50, 100 and 300 mg).
Croatian: Dostupan je u obliku kapsula (25, 50 i 100 mg) i raspadljivih tableta za usta (25, 50, 100 i 300 mg).
English: This may help to stabilise electrical activity in the brain.
Croatian: To može pomoći u stabilizaciji električne aktivnosti u mozgu.
English: Before stopping Zonegran, the dose should be decreased gradually.
Croatian: Prije prestanka uzimanja lijeka Zonegran, dozu treba postupno smanjivati.
English: These channels transmit electrical impulses between nerve cells.
Croatian: Ti kanali prenose električne impulse između živčanih stanica.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran on 10 March 2005.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Zonegran vrijedi na prostoru Europske unije od 10. ožujka 2005.
English: The full EPAR for Zonegran 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 Zonegran može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zonegran can be given once or twice a day after an appropriate dose is reached.
Croatian: Zonegran se može davati jednom ili dvaput na dan nakon što se postigne odgovarajuća doza.
English: The most common side effects with Zonegran (seen in more than 1 patient in 10) are loss of appetite, agitation, irritability, confusion, depression, ataxia (an inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels; although the safety profile is similar in children and adults, some side effects are reported more frequently in children than in adults.
Croatian: Najčešće nuspojave uočene s lijekom Zonegran (viđene kod više od 1 na 10 bolesnika) su gubitak apetita, agitacija, iritabilnost, konfuzija, depresija, ataksija (nesposobnost koordinacije pokreta mišića), omaglica, oštećenje memorije, somnolencija (pospanost), diplopija (dvoslike) i smanjene razine bikarbonata u krvi; iako je sigurnosni profil sličan u djece i odraslih neke se nuspojave prijavljuju češće u djece nego u odraslih.
English: The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Croatian: Postotak bolesnika na karbamazepinu koji nisu imali napadaje tijekom 6 mjeseci iznosio je 74,7 %.
English: Other information about Zonegran:
Croatian: Druge informacije o lijeku Zonegran:
English: Zonegran can cause heatstroke and de-hydration, particularly in children, and these need to be treated promptly.
Croatian: Zonegran može uzrokovati toplinski udar i dehidraciju, posebice u djece i te poremećaje treba odmah liječiti.
English: Two other main studies, one involving 351 adults and one involving 207 children (between 6 and 17 years old), looked at Zonegran as an add-on to existing treatment.
Croatian: Dva glavna ispitivanja od kojih je jedno uključivalo 351 bolesnika, a drugo 207 djece (u dobi između 6 i 17 godina) smatrala su Zonegran kao dodatak postojećoj terapiji.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Croatian: Epileptički napadaji uzrokovani su nenormalnom električnom aktivnosti u mozgu.
English: By blocking these channels, zonisamide prevents the nerve cells from synchronising their activity and prevents abnormal electrical activity spreading through the brain.
Croatian: Blokadom ovih kanala, zonisamid sprječava živčanih stanica od sinkronizacije njihove aktivnosti i sprječava nenormalnu električnu aktivnost koja se širi kroz mozak.
English: Zonegran was more effective than placebo at reducing the frequency of seizures when used as an ‘addon' to existing treatment.
Croatian: Zonegran je bio djelotvorniji od placeba u redukciji učestalosti napadaja kad se koristi kao „dodatak” postojećem liječenju.
English: For more information about treatment with Zonegran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Zonegran pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Adults taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Croatian: Odrasli koji uzimaju 500 mg Zonegrana po danu imali su prosječnu redukciju u učestalosti napadaja od 51 % u usporedbi sa 16 % onih koji su uzimali placebo.
English: What is Zonegran?
Croatian: Što je Zonegran?
English: These studies compared Zonegran with placebo (a dummy treatment).
Croatian: Ova su ispitivanja uspoređivala Zonegran s placebom (slijepo liječenje).
English: Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Croatian: Zonegran ne smiju koristiti osobe koje su preosjetljive (alergične) na zonisamidom na bilo koji drugi sastojak ili na sulfonamide (poput nekih antibiotika).
English: Zonegran is used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Croatian: Zonegran se koristi za liječenje bolesnika s parcijalnim napadajima (epileptički napadaji koje počinju u jednom dijelu mozga) uključujući one sa sekundarnom generalizacijom (kod kojih se napadaj širi naknadno na cijeli mozak).
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 Zonegran.
Croatian: Objašnjava kako je Povjerenstvo za humane lijekove (CHMP) ocijenilo lijek Zonegran da bi postiglo mišljenje u korist davanja odobrenja za stavljanje u promet i preporučilo uvjete za njegovu primjenu.
English: Zonegran used on its own was compared with carbamazepine, another anti-epileptic medicine, in a main study involving 583 adults newly diagnosed with partial epilepsy.
Croatian: Zonegran u samostalnoj primjeni uspoređen je s karbamazepinom, drugim antiepileptikom u glavnom ispitivanju koje je uključivalo 583 bolesnika s novodijagnosticiranom parcijalnom epilepsijom.
English: What is the risk associated with Zonegran?
Croatian: Koji su rizici povezani s lijekom Zonegran?
English: In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Croatian: U djece se broj napadaja najmanje prepolovio u 50% bolesnika koji uzimaju Zonegran u usporedbi s 31 % onih koji su uzimali placebo.
English: This document is a summary of the European public assessment report (EPAR) for Zonegran.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Zonegran.
English: After one week the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week, depending on the patient's response.
Croatian: Nakon tjedan dana doza se može povećati na 50 mg dva puta dnevno i potom povećavati za 100 mg svaki tjedan, ovisno o bolesnikovom odgovoru.
English: Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Croatian: Možda će biti potrebno rjeđe povećavati dozu u bolesnika koji imaju probleme s jetrom ili bubrezima ili oni koji uzimaju određene druge lijekove.
English: Zonegran used on its own was shown to be beneficial in adults with partial seizures: 69.4% of patients on Zonegran were seizure-free for six months.
Croatian: Dokazano je da Zonegran u samostalnoj primjeni može koristiti odraslima s djelomičnim napadajima: Tijekom 6 mjeseci, 69,4 % bolesnika koji su primali Zonegran nisu imali napadaje.
English: The total dose must not exceed 500 mg a day.
Croatian: Ukupna doza ne smije premašiti 500 mg na dan.
English: Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Croatian: Teški osipi pojavljivali su se u bolesnika koji su primali Zonegran uključujući slučajeve Stevens-Johnsonova sindroma (teške, po život opasne alergijske reakcije koja zahvaća kožu i sluznice).
English: After one or two weeks, the daily dose may be increased in steps of 1 mg per kg every one or two weeks until an appropriate dose is reached.
Croatian: Nakon tjedan ili dva, dnevna doza može se povećati u koracima od 1 mg po kg svaki tjedan ili dva sve dok se ne postigne odgovarajuća doza.
English: Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Croatian: Zonisamid djeluje blokadom specifičnih pora na površini živčanih stanica zvanih natrijevi i kalcijevi kanali.
English: What benefit has Zonegran shown during the studies?
Croatian: Koje su koristi Zonegrana dokazane u ispitivanjima?
English: The usual maintenance dose is 300 mg a day.
Croatian: Uobičajena doza održavanja iznosi 300 mg na dan.
English: In the study involving adults, the main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Croatian: U ispitivanju koje je uključivalo odrasle, glavna mjera djelotvornosti bila je promjena učestalosti djelomičnih napadaja između 12 tjedana prije početka liječenja i 18-tjednog razdoblja kad je korištena stabilna doza.
English: When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Croatian: Kad se Zonegran koristi kao „dodatak” postojećoj terapiji u djece u dobi od 6 godina i iznad, doza ovisi o tjelesnoj težini; preporučena početna doza je 1 mg po kg tjelesne težine na dan.
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged 6 years and above already receiving other antiepilepsy medicines.
Croatian: Koristi se samostalno kod novodijagnosticiranih odraslih bolesnika i djece u dobi od 6 godina i starije koja primaju druge antiepileptike.
English: Zonegran is a medicine that contains the active substance zonisamide.
Croatian: Zonegran je lijek koji sadrži djelatnu tvar zonisamid.
English: This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Croatian: Zonegran također djeluje na neurotransmiter gama amino maslačnu kiselinu (GABA, kemikalija koja omogućava da živčane stanice komuniciraju jedna s drugom).
English: When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Croatian: Kad se Zonegran koristi samostalno kod novodijagnosticiranih odraslih bolesnika, preporučena početna doza je 100 mg jednom na dan tijekom dva tjedna što se može povećati za 100 mg u intervalima od dva tjedna.
English: The main measure of effectiveness was the proportion of patients who were seizure-free for a period of six months.
Croatian: Glavna mjera djelotvornosti bio je udio bolesnika bez napadaja tijekom razdoblja od 6 mjeseci.
English: The usual maintenance dose is between 300 and 500 mg a day.
Croatian: Uobičajena je doza održavanja između 300 i 500 mg na dan.
English: When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Croatian: Kad se Zonegran koristi kao „dodatak” postojećim terapijama, preporučena početna doza je 25 mg dvaput dnevno.
English: In the study in children, the main measure of effectiveness was the proportion of patients in whom the number of seizures was at least halved between the 8 weeks before treatment started and the 12-week period when a stable dose was used.
Croatian: U ispitivanju na djeci, glavna mjera djelotvornosti bila je udio bolesnika i kojih je broj napadaja bio barem prepolovljen između 8 tjedana prije početak liječenja i 12-tjednog razdoblja kad je korištena stabilna doza.
English: The active substance in Zonegran, zonisamide, is an anti-epileptic.
Croatian: Djelatna tvar u lijeku Zonegran je zonisamid, antiepileptik.
English: Why has Zonegran been approved?
Croatian: Za što je Zonegran odobren?
English: The CHMP decided that Zonegran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za humane lijekove (CHMP) pri Agenciji odlučilo je da koristi od lijeka Zonegran nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za stavljanje u promet.
English: What is Zonegran used for?
Croatian: Za što se Zonegran koristi?
English: For the full list of all side effects reported with Zonegran, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Zonegran potražite u uputi o lijeku.
English: How is Zonegran used?
Croatian: Kako se Zonegran koristi?
English: How does Zonegran work?
Croatian: Kako djeluje Zonegran?
English: How has Zonegran been studied?
Croatian: Kako se Zonegran ispitivao?
English: Alcohol may modify or increase the effect of other medicines.
Croatian: Alkohol može promijeniti ili pojačati učinak drugih lijekova.
English: Other possible interactions
Croatian: Druge moguće interakcije
English: These may be symptoms of a serious allergic reaction.
Croatian: To mogu biti simptomi ozbiljne alergijske reakcije.
English: Follow your doctor's instructions exactly, and never change the dose yourself.
Croatian: Točno se pridržavajte uputa liječnika i nikad nemojte sami mijenjati dozu.
English: You may need to repeat step 3 more than once to deliver your dose.
Croatian: Možda ćete morati korak 3 ponavljati više od jedanput kako biste isporučili Vašu dozu.
English: Frequency not known (cannot be estimated from available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Do not take Rapamune:
Croatian: Nemojte uzimati Rapamune:
English: Rapamune with food and drink
Croatian: Rapamune s hranom i pićem
English: One death occurred in each group.
Croatian: U svakoj je skupini zabilježen po jedan smrtni slučaj.
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 međutim nije moguće dati preporuku o doziranju.
English: Thereafter, the difference between the two groups was not significant.
Croatian: Nakon toga vremena, razlika između skupina više nije bila značajna.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite s Vašim liječnikom ili ljekarnikom ukoliko niste sigurni.
English: if you are allergic to peanut or soya.
Croatian: - ako ste alergični na kikiriki ili soju.
English: There was a large variability for individuals within the age groups.
Croatian: Postojala je značajna individualna varijabilnost unutar dobnih skupina.
English: Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days.
Croatian: Nakon otvaranja boce, sadržaj treba čuvati u hladnjaku i primijeniti u roku od 30 dana.
English: The concentration values obtained by these different methodologies are not interchangeable.
Croatian: Vrijednosti koncentracije dobivene ovim dvjema različitim metodama ne mogu se međusobno uspoređivati.
English: Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
Croatian: Liječnik će odlučiti koju točno dozu lijeka Rapamune morate uzimati i koliko često morate uzimati lijek.
English: Rapamune reduces your body's own defence mechanisms.
Croatian: Rapamune slabi obrambene mehanizme Vašeg tijela.
English: *Note: p-values not controlled for multiple testing.
Croatian: *Napomena: p-vrijednosti nisu kontrolirane za multipla testiranja.
English: Sirolimus is the major component in human whole blood and contributes to greater than 90% of the immunosuppressive activity.
Croatian: Sirolimus je glavna komponenta u punoj ljudskoj krvi i pridonosi više od 90% imunosupresivnom djelovanju.
English: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG United Kingdom
Croatian: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG Ujedinjeno Kraljevstvo
English: Store in a refrigerator (2C - 8C).
Croatian: Čuvati u hladnjaku (2C -8C).
English: After that, continue to take your medicines as usual.
Croatian: Nakon toga nastavite uzimati svoje lijekove prema uobičajenom rasporedu.
English: if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na sirolimus ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: 30 days for opened bottle.
Croatian: 30 dana nakon otvaranja boce.
English: If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
Croatian: Ako uzimate i ciklosporin, onda ova dva lijeka morate uzeti u razmaku od približno 4 sata.
English: Instructions for use and handling:
Croatian: Upute za uporabu i rukovanje:
English: Therapeutic monitoring of the medicinal product should not be the sole basis for adjusting sirolimus therapy.
Croatian: Terapijsko praćenje lijeka ne smije biti jedini temelj za prilagodbu terapije sirolimusom.
English: The changes may be related to chronic immunosuppression.
Croatian: Promjene mogu biti povezane s kroničnom imunosupresijom.
English: Periodic quantitative monitoring of urinary protein excretion is recommended.
Croatian: Preporučuje se povremena kvantitativna kontrola izlučivanja proteina u urinu.
English: Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu i uvijek uzimajte Rapamune i ciklosporin u razmaku od približno 4 sata.
English: Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant.
Croatian: Nemojte prestati uzimati Rapamune ako Vam to nije rekao liječnik, jer tako riskirate izgubiti presađeni organ.
English: After dilution (see section 6.6), the preparation should be used immediately.
Croatian: Nakon razrjeđivanja (vidjeti dio 6.6), pripravak se mora odmah primijeniti.
English: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgium
Croatian: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgija
English: Other medicines and Rapamune
Croatian: Drugi lijekovi i Rapamune
English: The most common symptom of S-LAM is shortness of breath.
Croatian: Najčešći simptom S-LAM-a je nedostatak zraka.
English: Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation.
Croatian: Liječnik će Vam dati početnu dozu od 6 mg čim to bude moguće nakon operacije presađivanja bubrega.
English: What Rapamune looks like and contents of the pack
Croatian: Kako Rapamune izgleda i sadržaj pakiranja
English: In addition, re-transplant recipients whose previous grafts survived for at least 6 months after transplantation were included.
Croatian: Nadalje, uključeni su i primatelji ponovnog presatka, čiji su prvotni presadci preživjeli najmanje 6 mjeseci nakon transplantacije.
English: Stir well for one minute and drink immediately at once.
Croatian: Dobro promiješajte jednu minutu i odmah popijte nadušak.
English: Optimal therapy requires therapeutic concentration monitoring of the medicinal product in all patients.
Croatian: Optimalna terapija zahtijeva praćenje terapijske koncentracije lijeka u svih bolesnika.
English: Use within 24 hours after filling the dosing syringe.
Croatian: Primijeniti u roku od 24 sata nakon punjenja dozirne štrcaljke.
English: At present, there is minimal experience with overdose.
Croatian: Sadašnja iskustva s predoziranjem su minimalna.
English: What Rapamune is and what it is used for
Croatian: Što je Rapamune i za što se koristi
English: The maximum Rapamune dose administered on any day should not exceed 40 mg.
Croatian: Maksimalna doza Rapamunea koja se daje tijekom jednog dana ne smije biti veća od 40 mg.
English: If you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests.
Croatian: Ako imate tegobe s jetrom ili ste bolovali od bolesti koja je mogla zahvatiti Vašu jetru, obavijestite o tome svog liječnika, jer to može utjecati na dozu lijeka Rapamune koju primate i znači da morate napraviti dodatne krvne pretrage.
English: What Rapamune contains
Croatian: Što Rapamune sadrži
English: Patients allergic to peanut or soya must not take this medicine.
Croatian: Bolesnici alergični na kikiriki ili soju ne smiju uzimati ovaj lijek.
English: Coated tablet (tablet).
Croatian: Obložena tableta (tableta).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).