FrancophonIA/ELRC3.0 huggingface dataset:
English: The second study involved 117 patients (including 20 children aged below 3 years) and compared Votubia with placebo (a dummy treatment).
Croatian: Drugo je ispitivanje obuhvatilo 117 bolesnika (uključujući 20-ero djece mlađe od tri godine) u kojem je lijek Votubia uspoređen s placebom (prividnim liječenjem).
English: • renal angiomyolipoma, a benign tumour of the kidneys, where it is used in adults who are at risk of complications but who do not require immediate surgery.
Croatian: • renalnih angiomiolipoma, benignog tumora bubrega, kad se koristi u odraslih osoba izloženih riziku od komplikacija, kojima nije potrebna hitna operacija.
English: How does Votubia work?
Croatian: Kako djeluje Votubia?
English: For more information about treatment with Votubia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Votubia pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se liječniku ili ljekarniku.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose kidney tumour shrank by at least half, which was seen in 42% of patients (33 out of 79) treated with Votubia, compared with none of the 39 patients who received placebo.
Croatian: Glavno mjerilo djelotvornosti bio je omjer bolesnika koji su reagirali na liječenje i čiji se tumor u bubregu smanjio za barem pola, što je zabilježeno u 42 % (33 od 79 bolesnika) liječenih lijekom Votubia, u usporedbi s niti jednim od 39 bolesnika koji su primali placebo.
English: What benefits of Votubia have been shown in studies?
Croatian: Koje su koristi od lijeka Votubia utvrđene u ispitivanjima?
English: The medicine is also used as an add-on treatment in patients from 2 years of age with seizures (fits) related to tuberous sclerosis that have not responded to other treatments.
Croatian: Lijek se također koristi i kao dodatna terapija u bolesnika u dobi od dvije godine i starijih s napadima povezanima s tuberoznom sklerozom koji nisu reagirali na druge terapije.
English: The active substance in Votubia, everolimus, is an anti-tumour medicine that acts by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR), which has increased activity in tumour cells of patients with SEGA or renal angiomyolipoma.
Croatian: Djelatna tvar u lijeku Votubia, everolimus, lijek je protiv tumora koji djeluje blokiranjem enzima naziva „ciljna molekula rapamicina u sisavaca” (mTOR) čija je aktivnost pojačana u tumorskim stanicama bolesnika sa SEGA-om ili renalnim angiomiolipomima.
English: Starting doses may need to be reduced, or treatment avoided, in patients with reduced liver function, depending on how severe this is and on the patient's age and the condition they are being treated for.
Croatian: Možda će početne doze trebati smanjiti, odnosno terapija se neće moći primijeniti u bolesnika sa smanjenom funkcijom bubrega, što ovisi o težini poremećaja, dobi bolesnika i stanju koje se liječi.
English: Overall, the patients given Votubia had a 29 and 40% reduction respectively in the number of seizures during treatment, compared with a 15% reduction in those given placebo.
Croatian: Općenito, u bolesnika koji su primali lijek Votubia, zabilježen je manji broj napada tijekom terapije od 29 %, odnosno 40 %, u usporedbi s 15 % smanjenja u osoba koje su primale placebo.
English: The benefits of Votubia as an add-on treatment of partial onset seizures related to tuberous sclerosis that have not been sufficiently controlled by other treatments have been shown in one main study.
Croatian: Koristi od lijeka Votubia kao dodatne terapije za djelomične napade povezane s tuberoznom sklerozom koju nije moguće u dovoljnoj mjeri kontrolirati drugim terapijama ispitivano je u jednom glavnom ispitivanju.
English: Votubia has been shown to be effective at treating patients with SEGA and renal angiomyolipoma by shrinking the volume of the tumours.
Croatian: Lijek Votubia pokazao se djelotvornim u liječenju bolesnika sa SEGA-om i renalnim angiomiolipomima smanjivanjem opsega tumora.
English: For more information about using Votubia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Votubia pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: This response was seen in 28% (33 of 117 patients) in the lower blood level group and 40% (52 of 130 patients) in the higher blood level group, compared with 15% (18 of 119) of patients taking placebo.
Croatian: Ta je reakcija zabilježena u 28 % (33 od 117 bolesnika) u skupini s nižim razinama lijeka u krvi, odnosno 40 % (52
English: How is Votubia used?
Croatian: Kako se Votubia koristi?
English: For the full list of all side effects reported with Votubia, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Votubia potražite u uputi o lijeku.
English: Although surgery remains the standard treatment for this condition, Votubia is expected to benefit patients whose tumour cannot be operated on. Votubia has also been shown to reduce the size of kidney tumours in patients with renal angiomyolipoma and has been shown to be beneficial as an add-on treatment in the management of partial-onset seizures related to tuberous sclerosis that have not sufficiently responded to other therapy.
Croatian: Utvrđeno je i da lijek Votubia smanjuje veličinu tumora u bubregu u bolesnika s renalnim angiomiolipomima te se pokazao djelotvornim kao dodatna terapija u upravljanju djelomičnim napadima povezanima s tuberoznom sklerozom na koje druge terapije nisu u dovoljnoj mjeri djelovale.
English: This overview was last updated in February 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 2. 2018.
English: Further information on Clevor can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Clevor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: If the dog does not vomit within 15 minutes of treatment, treatment may be repeated.
Croatian: Ako pas ne povrati u roku od 15 minuta nakon tretiranja, ono se može ponoviti.
English: If a dose of more than one drop is needed it should be divided between both eyes and when 6 or more drops are to be given the dose should be divided into 2 separate treatments given 12 minutes apart.
Croatian: Ako potrebna doza iznosi više od jedne kapi, treba je podijeliti na oba oka, a kada je potrebna primjena šest ili više kapi, dozu treba podijeliti na dvije odvojene primjene u razmaku od jedne do dvije minute.
English: Ropinirole is a dopamine agonist, which means that it imitates the action of dopamine.
Croatian: Ropinirol je agonist dopamina, što znači da imitira djelovanje dopamina.
English: In the group of 32 dogs which received placebo eye drops only one dog vomited.
Croatian: U skupini od 32 psa koji su primili placebo kapi za oči povratio je samo jedan pas.
English: What is Clevor and what is it used for?
Croatian: Što je Clevor i za što se koristi?
English: Other information about Clevor
Croatian: Ostale informacije o VMP-u Clevor
English: By stimulating this part of the brain ropinirole triggers vomiting.
Croatian: Stimulirajući ovaj dio mozga ropinirol potiče povraćanje.
English: Clevor is a veterinary medicine used to induce vomiting in dogs.
Croatian: Clevor je veterinarsko-medicinski proizvod koji se koristi za izazivanje povraćanja u pasa.
English: Why is Clevor authorised in the EU?
Croatian: Zašto je Clevor odobren u EU-u?
English: Clevor must not be used in dogs:
Croatian: VMP Clevor ne smije se primjenjivati u pasa:
English: • with central nervous system depression (low levels of consciousness), seizures (fits) or other problems with the nervous system which could lead to inhalation pneumonia (lung damage due to content from the stomach entering the lungs).
Croatian: • s depresijom središnjeg živčanog sustava (niska razina svijesti), napadajima ili s drugim problemima živčanog sustava koji bi mogli dovesti do aspiracijske pneumonije (oštećenje pluća uzrokovano ulaskom sadržaja iz želuca u pluća).
English: The European Medicines Agency decided that Clevor's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a Clevor nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: People who are hypersensitive (allergic) to ropinirole should avoid contact with Clevor.
Croatian: Osobe koje su preosjetljive (alergične) na ropinirol trebaju izbjegavati kontakt s VMP-om Clevor.
English: A second dose was given after 20 minutes to 13% of the dogs as they had not vomited.
Croatian: Nakon 20 minuta primijenjena je druga doza u 13 % pasa koji nisu povratili.
English: It contains the active substance ropinirole.
Croatian: Sadrži djelatnu tvar ropinirol.
English: Clevor is an eye drop solution, given into the eye at a dose of 1-8 drops according to the dog's bodyweight.
Croatian: Clevor je otopina kapi za oči koja se primjenjuje u oko u dozi od 1 do 8 kapi sukladno tjelesnoj težini psa.
English: An overview of Clevor and why it is authorised in the EU
Croatian: Pregled VMP-a Clevor i zašto je odobren u EU-u
English: • which are hypoxic (have lower than normal oxygen levels in the blood), dyspnoeic (have difficulty breathing) or lack pharyngeal (swallowing) reflexes.
Croatian: • koji su hipoksični (imaju nižu razinu kisika u krvi od uobičajene), dispneični (imaju poteškoće s disanjem) ili im nedostaju refleksi ždrijela (gutanje).
English: What are the risks associated with Clevor?
Croatian: Koji su rizici povezani s VMP-om Clevor?
English: The most common side effects with Clevor (which may affect more than 1 in 10 animals) are shortlived, mild hyperaemia (redness) of the eye, discharge from the eye, protrusion of the third eyelid, blepharospasm (closure of the eyelids due to muscle contraction), short-lived mild lack of energy and increased heart rate.
Croatian: Najčešće nuspojave VMP-a Clevor (mogu se javiti u više od 1 na 10 životinja) su kratkotrajna blaga hiperemija (crvenilo) oka, iscjedak iz oka, ispadanje trećeg očnog kapka, blefarospazam (zatvaranje kapaka uzrokovano kontrakcijom mišića), kratkotrajan blagi nedostatak energije i ubrzani puls.
English: The medicine should only be given by a veterinarian or under his/her close supervision and can only be obtained with a prescription.
Croatian: VMP treba primjenjivati samo veterinar ili osoba pod njegovim/njezinim pomnim nadzorom, a izdaje se samo na veterinarski recept.
English: Pregnant or breast-feeding women should not handle this medicine.
Croatian: Žene koje su trudne ili doje ne smiju rukovati ovim VMP-om.
English: If symptoms occur, medical advice should be sought and the package leaflet or label shown to the doctor.
Croatian: U slučaju pojave simptoma potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
English: • which have swallowed sharp foreign objects, corrosive agents, volatile substances or organic solvents.
Croatian: • koji su progutali oštra strana tijela, korozivne agense, hlapljive tvari ili organska otapala.
English: In a field trial involving 132 healthy dogs which compared Clevor with placebo (dummy treatment), 95% of the dogs vomited within 30 minutes.
Croatian: VMP Clevor uspoređen je s placebom (prividno liječenje) u terenskom ispitivanju koje je obuhvatilo 132 zdrava psa, od kojih je 95 % povratilo unutar 30 minuta.
English: Dopamine is a messenger substance in the part of the brain which controls vomiting.
Croatian: Dopamin je tvar koja djeluje kao glasnik u dijelu mozga koji kontrolira povraćanje.
English: How is Clevor used?
Croatian: Kako se Clevor koristi?
English: Three dogs did not vomit at all despite a second dose.
Croatian: Unatoč drugoj dozi, tri psa nisu povratila.
English: How does Clevor work?
Croatian: Kako djeluje Clevor?
English: For more information about using Clevor, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Clevor pogledajte uputu o VMP-u, odnosno obratite se svom veterinaru ili ljekarniku.
English: What benefits of Clevor have been shown in studies?
Croatian: Koje su koristi VMP-a Clevor utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Clevor, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni VMP-a Clevor potražite u uputi o VMP-u.
English: Clevor received a marketing authorisation valid throughout the EU on 13 April 2018.
Croatian: Za VMP Clevor izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od
English: Your doctor will tell you if you need to change the amount of other medicines you take.
Croatian: Liječnik će Vam reći trebate li promijeniti količinu drugih lijekova koje uzimate.
English: ATC code: A10BH04.
Croatian: ATK oznaka: A10BH04.
English: What Vipidia is and what it is used for
Croatian: Što je Vipidia i za što se koristi
English: Adults (≥ 18 years old)
Croatian: Odrasli (≥ 18 godina starosti)
English: The magnitude of these reductions was not considered to be clinically relevant.
Croatian: Smatra se da opseg takvog sniženja nije klinički značajan.
English: Frequencies are defined as 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 available data).
Croatian: Učestalosti su definirane kao vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: A causal relationship has not been established.
Croatian: Uzročna povezanost nije ustanovljena.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Croatian: To omogućuje kontinuirano praćenje omjera koristi/rizika lijeka.
English: Your doctor will help you to decide whether to continue breast-feeding or to continue using Vipidia.
Croatian: Vaš će vam liječnik pomoći u odluci da li da nastavite s dojenjem ili da nastavite koristiti lijek Vipidia.
English: It is important that you continue to take your other anti-diabetic medicine, and continue to follow the advice on diet and exercise that your nurse or doctor has given you.
Croatian: Važno je da nastavite uzimati druge antidijabetičke lijekove, te da nastavite slijediti savjete o dijeti i tjelovježbi koje ste dobili od medicinske sestre ili liječnika.
English: Other medicines and Vipidia
Croatian: Drugi lijekovi i Vipidia
English: Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Croatian: HbA1c bila su slična u različitim podskupinama uključujući oštećenje bubrega, dob, spol i indeks tjelesne mase, dok su razlike između rasa (npr. bijelci i ne-bijelci) bile male.
English: Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing.
Croatian: Inhibicija DPP-4 zadržala se iznad 81% tijekom 24 sata i nakon 14 dana doziranja.
English: If you take more Vipidia than you should
Croatian: Ako uzmete više lijeka Vipidia nego što ste trebali
English: STOP taking Vipidia and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PREKINITE uzimanje lijeka Vipidia i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Generally, the effects of alogliptin on body weight and lipids were neutral.
Croatian: Općenito, učinci alogliptina na tjelesnu težinu i lipide bili su neutralni.
English: Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Croatian: Dob (65-81 godina starosti), spol, rasa (bijela, crna i Azijati) i tjelesna težina nisu imali nikakav klinički značajan učinak na farmakokinetiku alogliptina.
English: This may be 12.5 mg or 6.25 mg once a day, depending on the severity of your kidney disease.
Croatian: To može biti 12,5 mg ili 6,25 mg jedanput na dan, ovisno o težini bolesti bubrega.
English: If you have kidney disease your doctor may prescribe you a reduced dose.
Croatian: Ako imate bolest bubrega liječnik će Vam možda propisati sniženu dozu.
English: Do not stop taking Vipidia without consulting your doctor first.
Croatian: Ne prekidajte uzimanje lijeka Vipidia bez savjetovanja s liječnikom.
English: Vipidia should be taken once daily with or without food.
Croatian: Lijek Vipidia treba uzeti jedanput na dan s hranom ili bez nje.
English: No dose adjustment is necessary based on age.
Croatian: Nije potrebna prilagodba doze s obzirom na dob.
English: Vipidia works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Croatian: Vipidia djeluje tako da povisuje razine inzulina u tijelu nakon obroka i smanjuje količinu šećera u tijelu.
English: What Vipidia contains - The active substance is alogliptin.
Croatian: Što Vipidia sadrži - Djelatna tvar je alogliptin.
English: If pancreatitis is suspected, Vipidia should be discontinued; if acute pancreatitis is confirmed, Vipidia should not be restarted.
Croatian: Ako se sumnja na pankreatitis, liječenje lijekom Vipidia treba prekinuti; ako se potvrdi akutni pankreatitis, Vipidia se ne smije ponovno primjenjivati.
English: If an abnormality is found and an alternative etiology is not established, consider discontinuation of alogliptin treatment.
Croatian: Ako se pronađe abnormalnost i ne utvrdi se alternativna etiologija, treba razmotriti prekid liječenja alogliptinom.
English: Cardiovascular Death*
Croatian: Kardiovaskularna smrt*
English: Vipidia is not a substitute for insulin in insulin-requiring patients.
Croatian: Vipidia nije zamjena za inzulin u bolesnika kojima je on potreban.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain, which may radiate to the back.
Croatian: Bolesnike treba upozoriti na karakteristični simptom akutnog pankreatitisa: ustrajnu, jaku bol u abdomenu koja se može širiti prema leđima.
English: Combination with other anti-diabetic medicinal products
Croatian: Kombinacije s drugim antidijabetičkim lijekovima
English: Vipidia is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Croatian: Vipidia se ne preporučuje djeci i adolescentima u dobi do 18 godina zbog nedostatka podataka u tih bolesnika.
English: This medicine is not recommended for patients with severely reduced liver function due to the lack of data in these patients.
Croatian: Ovaj lijek se ne preporučuje bolesnicima s teško smanjenom funkcijom jetre jer nema podataka o primjeni u tih bolesnika.
English: Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Croatian: Alogliptin se eliminira sa srednjim terminalnim poluvijekom (T1/2) od približno 21 sat.
English: What Vipidia is and what it is used for What you need to know before you take Vipidia How to take Vipidia
Croatian: Što je Vipidia i za što se koristi Što morate znati prije nego počnete uzimati lijek Vipidia Kako uzimati lijek Vipidia
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vipidia in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Vipidia u jednoj ili više podskupina pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Croatian: Viša početna vrijednost HbA1c bila je povezana s većim smanjenjem HbA1c.
English: In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Croatian: U zdravih ispitanika, alogliptin nije imao učinak na protrombinsko vrijeme ili internacionalni normalizirani omjer (INR) kada se primjenjivao istodobno s varfarinom.
English: The absolute bioavailability of alogliptin is approximately 100%.
Croatian: Apsolutna bioraspoloživost alogliptina je približno 100%.
English: Vipidia should not be used during pregnancy or breast-feeding.
Croatian: Vipidia se ne smije koristiti tijekom trudnoće ili dojenja.
English: Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines.
Croatian: Vipidia se uzima kad se šećer u krvi ne može odgovarajuće kontrolirati dijetom, tjelovježbom i s jednim ili više drugih antidijabetičkih lijekova.
English: Furthermore, clinical data do not suggest interaction with p-glycoprotein inhibitors or substrates.
Croatian: Nadalje, klinički podaci ne ukazuju na interakciju s inhibitorima ili supstratima p-glikoproteina.
English: The recommended dose of Vipidia is 25 mg once a day.
Croatian: Preporučena doza lijeka Vipidia je 25 mg jedanput na dan.
English: What you need to know before you take Vipidia
Croatian: Što morate znati prije nego počnete uzimati lijek Vipidia
English: Experience of alogliptin use in clinical studies in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
Croatian: Iskustvo s primjenom alogliptina u kliničkim ispitivanjima u bolesnika s kongestivnim zatajenjem srca funkcionalnih klasa III i IV prema New York Heart Association (NYHA) klasifikaciji je ograničeno te je u tih bolesnika potreban oprez..
English: The (S)-enantiomer is not detectable at therapeutic doses.
Croatian: (S)-enantiomer nije pronađen u terapijskim dozama.
English: The safety and efficacy of Vipidia in children and adolescents < 18 years old have not been established.
Croatian: Sigurnost i djelotvornost lijeka Vipidia u djece i adolescenata < 18 godina starosti nisu ustanovljene.
English: Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets.
Croatian: Vipidia je dostupna u blister pakiranjima koja sadrže 10, 14, 28, 30, 56, 60, 84, 90, 98 ili 100 tableta.
English: Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged active substance in the urine.
Croatian: Alogliptin ne prolazi ekstenzivni metabolizam te se 60-70% doze izlučuje kao nepromijenjena djelatna tvar u mokraći.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/844/001-030
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/844/001-030
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na blisteru iza „EXP“.
English: Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9.
Croatian: Alogliptin je potentan i visoko selektivan inhibitor DPP-4, s > 10 000 puta većom selektivnošću za DPP-4 nego za druge srodne enzime, uključujući DPP-8 i DPP-9.
English: In a pre- and postnatal development study in rats, exposures far above the human exposure at the recommended dose did not harm the developing embryo or affect offspring growth and development.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja u štakora, izloženosti daleko iznad izloženosti kod ljudi pri preporučenoj dozi nisu naštetile razvoju embrija niti utjecale na rast i razvoj mladunčadi.
English: Vipidia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Vipidia se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 ili za liječenje dijabetičke ketoacidoze.