FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Simparica's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Simparica nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The active substance in Simparica, sarolaner acts as an ‘ectoparasiticide'.
Croatian: Djelatna tvar u VMP-u Simparica, sarolaner, djeluje kao „ektoparaziticid”.
English: Another study involved dogs infested with sarcoptic mange.
Croatian: Još jedno ispitivanje obuhvatilo je pse zaražene sarkoptozom.
English: For treatment of tick and flea infestations Simparica should be given once every month throughout the flea and/or tick season for optimal control.
Croatian: Za potrebe liječenja infestacija krpeljima i buhama, VMP Simparica daje se jednom svakih mjesec dana tijekom sezone krpelja i/ili buha radi optimalne kontrole.
English: Side effects with Simparica are not common.
Croatian: Nuspojave VMP-a Simparica nisu česte.
English: Simparica is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Croatian: Simparica je vrsta VMP-a koja se koristi za tretiranje infestacija krpeljima i buhama, demodikoze i sarkoptoze (infestacija kože koje uzrokuju dvije različite vrste grinja) i infestacija ušnim šugarcem kod pasa.
English: Dogs with live mites on day 30 after initial treatment received a second treatment.
Croatian: Psi sa živim grinjama primili su 30. dana nakon početnog liječenja drugu terapiju.
English: This is a summary of the European public assessment report (EPAR) for Simparica.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Simparica.
English: For Simparica the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Croatian: Prilikom liječenja VMP-om Simparica postotak pasa koji nisu imali žive grinje 30. dana iznosio je 91 %, s time da je taj postotak porastao do 99 % 60. dana, odnosno nakon dvije terapije.
English: Simparica can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Croatian: Simparica se može također koristiti kao dio strategije liječenja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
English: The effectiveness of Simparica against fleas was investigated in a field study in dogs infested with at least five live fleas.
Croatian: Djelovanje VMP-a Simparica protiv buha ispitano je u terenskom ispitivanju u pasa zaraženih s najmanje pet živih buha.
English: Simparica was as effective as moxidectin/imidacloprid.
Croatian: VMP Simparica bio je jednako djelotvoran kao moksidektin/imidakloprid.
English: After Simparica is given its activity against ticks and fleas lasts for at least 5 weeks.
Croatian: Nakon primjene VMP-a Simparica, on djeluje protiv krpelja i buha najmanje 5 tjedana.
English: A field study was conducted in dogs infested with at least three live attached ticks.
Croatian: Drugo terensko ispitivanje provedeno je u pasa zaraženih najmanje trima živim primljenim krpeljima.
English: What benefits of Simparica have been shown in studies?
Croatian: Koje su koristi VMP-a Simparica utvrđene u ispitivanjima?
English: How is Simparica used?
Croatian: Kako se Simparica koristi?
English: For treatment of demodectic mange Simparica should be given once a month for at least three months.
Croatian: Za potrebe liječenja demodikoze, Simparica se daje jednom mjesečno u razdoblju od barem tri mjeseca.
English: Simparica was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Croatian: VMP Simparica bio je jednako djelotvoran kao moksidektin i imidakloprid u eliminaciji živih grinja u kožnim strugotinama.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with Simparica and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Croatian: U ispitivanju koje je obuhvatilo pse s infestacijom ušnim škugarcem, 283 psa liječeno je VMP-om Simparica, a 131 pas primio je moksidektin/imidakloprid (terapiju nakapavanjem protiv grinja).
English: How does Simparica work?
Croatian: Kako djeluje Simparica?
English: For treatment of sarcoptic mange, Simparica is given monthly for two consecutive months.
Croatian: Za potrebe liječenja sarkoptoze, Simparica se daje jednom mjesečno tijekom dva uzastopna mjeseca.
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with Simparica monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Croatian: U ispitivanju koje je obuhvatilo 98 pasa s demodikozom, 63 psa liječena su VMP-om Simparica jednom mjesečno u razdoblju od najviše šest mjeseci, a 35 pasa primilo je moksidektin/imidakloprid.
English: Simparica was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Croatian: VMP Simparica bio je jednako djelotvoran kao fipronil u smanjivanju broja krpelja do 90 dana nakon terapije.
English: Simparica was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Croatian: VMP Simparica bio je jednako djelotvoran kao spinosad u smanjivanju broja buha do 90 dana nakon terapije.
English: 122 dogs were treated with Simparica for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Croatian: Tijekom tri mjeseca 122 psa liječena su VMP-om Simparica dok je 59 pasa liječeno drugim VMP-om, fipronilom, protiv krpelja.
English: 189 dogs were treated with Simparica for three months whilst 96 dogs were given another medicine, spinosad.
Croatian: Tijekom tri mjeseca 189 pasa liječeno je VMP-om Simparica dok je 96 pasa primilo drugi VMP, spinosad.
English: 53 dogs were treated with Simparica for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Croatian: 53 pasa liječeno je VMP-om Simparica tijekom tri mjeseca, dok je 26 pasa primilo VMP koji je sadržavao moksidektin i imidakloprid.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Simparica, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u Simparica, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For practical information about using Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Simparica vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno obratiti se svojem veterinaru ili ljekarniku.
English: For more information about treatment with Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Simparica vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno obratiti se svojem veterinaru ili ljekarniku.
English: This summary was last updated in 08-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 08. 2014.
English: The tablets must be chewed and not swallowed whole.
Croatian: Tablete se moraju žvakati i ne smiju se gutati cijele.
English: The risk of excess iron build-up was considered limited but should be followed up after approval.
Croatian: Rizik od prekomjernog nakupljanja željeza smatra se ograničenim, no pratit će se nakon izdavanja odobrenja.
English: The full EPAR and risk management plan summary for Velphoro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Velphoro nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals.
Croatian: Preporučena početna doza je 1.500 mg (3 tablete) na dan, koje se uzimaju u podijeljenim dozama uz obroke.
English: Velphoro is available as chewable tablets (containing 500 mg of iron).
Croatian: Velphoro je dostupan kao tablete za žvakanje (sadrži 500 mg željeza).
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Croatian: Bolesnici s teškom bolesti bubrega ne mogu eliminirati fosfate iz svog tijela.
English: This leads to hyperphosphataemia (high blood phosphate levels), which, in the long term, can cause complications such as heart and bone disease.
Croatian: Ovo rezultira hiperfosfatemijom (visokom koncentracijama fosfata u krvi), što, dugoročno može uzrokovati komplikacije poput bolesti srca i kosti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Velphoro na snazi u Europskoj uniji od 26. kolovoza 2014.
English: After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer.
Croatian: Nakon 3 mjeseca liječenja, koncentracije fosfata u krvi snizile su se prosječno za 0,7 mmol/L s lijekom Velphoro u usporedbi s 0,8 mmol/L sa sevelamerom, te nakon 6 mjeseci terapije 53% bolesnika koji su primali Velphoro imalo je normalne koncentracije fosfata u krvi (1,13 do 1,78 mmol/L) u usporedbi s 54% bolesnika koji su primali sevelamer.
English: There were no major safety concerns and although tolerability is slightly lower than with sevelamer, the overall safety profile was acceptable.
Croatian: Nema većih razloga za zabrinutost te iako je tolerantnost nešto manja u odnosu na sevelamer, ukupan sigurnosni profil je prihvatljiv.
English: Other information about Velphoro
Croatian: Ostale informacije o lijeku Velphoro
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Velphoro nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: The study looked at the change in the amount of phosphate in the blood, measured in units of mmol/L.
Croatian: Ispitivanje je istražilo promjene u količini fosfata u krvi, izmjerenoj u jedinici mmol/L.
English: After 6 months, more than half of the patients could then continue on the same treatment for up to one year, while a small group received Velphoro at a lower dose for three weeks only.
Croatian: Nakon 6 mjeseci, više od polovice bolesnika moglo je nastaviti istu terapiju do maksimalno godine dana, dok je mala grupa primila Velphoro u manjoj dozi tijekom samo tri tjedna.
English: This is a summary of the European public assessment report (EPAR) for Velphoro.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Velphoro.
English: Why is Velphoro approved?
Croatian: Zašto je Velphoro odobren?
English: The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).
Croatian: Djelatna tvar u ovog lijeka je saharoželjezov oksihidroksid (također poznat kao mješavina polinuklearnog željezovog(III)- oksihidroksida, sukroze (šećera) i škrobova).
English: The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels.
Croatian: CHMP je zaključio da je Velphoro pokazao jasne korisne učinke u snižavanju koncentracije fosfata.
English: What measures are being taken to ensure the safe and effective use of Velphoro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Velphoro?
English: It is not intended to provide practical advice on how to use Velphoro.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Velphoro.
English: What is Velphoro and what is it used for?
Croatian: Što je Velphoro i za što se koristi?
English: The dose of Velphoro should be adjusted every two to four weeks, until an acceptable level of phosphate in the blood is reached, which should then be monitored regularly.
Croatian: Dozu lijeka Velphoro potrebno je prilagoditi svaka dva do četiri tjedna, sve dok se ne postigne zadovoljavajuća razina fosfora u serumu, uz redovito praćenje nakon toga.
English: A risk management plan has been developed to ensure that Velphoro is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Velphoro.
English: All patients were on dialysis and received either Velphoro or another phosphate binder, sevelamer, for 6 months.
Croatian: Svi su bolesnici bili na dijalizi i primali Velphoro ili drugi vezač fosfata, sevelamer, tijekom razdoblja od 6 mjeseci.
English: In patients whose dose of Velphoro was then lowered, phosphate levels increased after 3 weeks, whereas the levels remained stable in those who continued treatment on the same dose for up to one year.
Croatian: U bolesnika čija je doza lijeka Velphoro snižena, koncentracije fosfata povećale su se nakon 3 tjedna, pri čemu su koncentracije ostale stabilne u bolesnika čije je liječenje nastavljeno istom dozom tijekom razdoblja do godine dana.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velphoro, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Velphoro nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information about treatment with Velphoro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Velphoro pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: When taken with meals, the iron contained in Velphoro attaches to phosphate from food within the gut, preventing it from being absorbed into the body and helping to keep down the phosphate levels in the blood.
Croatian: Kada se uzima uz obroke, željezo sadržano u lijeku Velphoro vezuje se na fosfate iz hrane u crijevima čime se sprječava adsorpcija fosfata u tijelu te pomaže pri održavanju niskih koncentracija fosfata u krvi.
English: Patients should keep to their prescribed low-phosphate diets.
Croatian: Bolesnici se trebaju pridržavati svoje prehrane siromašne fosfatima.
English: Velphoro is used with other treatments such as calcium or vitamin-D supplements which help to control bone disease linked to kidney failure and high phosphate levels.
Croatian: Velphoro se koristi zajedno s drugim terapijama poput dodataka prehrani u obliku kalcija ili vitamina D koji pomažu pri kontroli koštane bolesti povezane sa zatajenjem bubrega i visokim koncentracijama fosfata.
English: Velphoro must not be used in patients with iron accumulation disorders such as haemochromatosis.
Croatian: Velphoro se ne smije koristiti u bolesnika s poremećajem akumulacije željeza poput hemokromatoze.
English: Velphoro sucroferric oxyhydroxide
Croatian: Velphoro saharoželjezov oksihidroksid
English: Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia.
Croatian: Velphoro je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 1059 odraslih osoba s kroničnom bolesti bubrega i hiperfosfatemijom.
English: What are the risks associated with Velphoro?
Croatian: Koji su rizici povezani s lijekom Velphoro?
English: The maximum dose is 3,000 mg (6 tablets) per day.
Croatian: Maksimalna preporučena doza je 3000 mg željeza na dan.
English: The active substance in Velphoro, sucroferric oxyhydroxide, is a phosphate binder.
Croatian: Djelatna tvar lijeka Velphoro, saharoželjezov oksihidroksid, je vezač fosfata.
English: Velphoro was as effective as sevelamer in reducing patients' blood-phosphate levels and maintaining this effect.
Croatian: Velphoro je bio podjednako djelotvoran kao sevelamer u snižavanju koncentracije fosfata u krvi bolesnika i održavanju ovog djelovanja.
English: The most common side effects with Velphoro (which may affect more than 1 in 10 people) are diarrhoea and discoloured faeces, which may become less frequent with continued treatment.
Croatian: Najčešće nuspojave lijeka Velphoro (mogu se javiti u više od 1 na 10 osoba) su proljev i promjena u boji izmeta, što se rjeđe javlja kako napreduje terapija.
English: Velphoro is a medicine used to control blood-phosphate levels in adults with long-term kidney disease who are undergoing haemodialysis or peritoneal dialysis to remove waste products from the blood.
Croatian: Velphoro je lijek indiciran za kontrolu razine fosfora u krvi u odraslih bolesnika s kroničnom bolešću bubrega na hemodijalizi ili peritonealnoj dijalizi kako bi se uklonile otpadne tvari iz krvi.
English: How is Velphoro used?
Croatian: Kako se Velphoro koristi?
English: For practical information about using Velphoro, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Velphoro pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Velphoro have been shown in studies?
Croatian: Koje su koristi lijeka Velphoro utvrđene u ispitivanjima?
English: How does Velphoro work?
Croatian: Kako djeluje Velphoro?
English: For the full list of all side effects and restrictions with Velphoro, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Velphoro potražite u uputi o lijeku.
English: The average half-life is of about 1.5 hours.
Croatian: Prosječni poluvijek je oko 1,5 sati.
English: If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day.
Croatian: Ako zaboravite primijeniti Preotact (ili ga niste mogli primijeniti u uobičajeno vrijeme), uzmite ga taj dan čim je prije moguće.
English: The results for these subjects were not different from the results in the study as a whole.
Croatian: Rezultati kod ovih osoba nisu se razlikovali od rezultata ispitivanja u cjelini.
English: You will hear a “click” (see picture).
Croatian: Čut ćete “klik” (vidi sliku).
English: You will hear and feel a click at the end.
Croatian: Na kraju ćete osjetiti i čuti “klik”.
English: • Do not share your medication with others.
Croatian: • Ne dijelite svoj lijek s drugima.
English: The disease progresses gradually so you may not feel any symptoms at first.
Croatian: Bolest postepeno napreduje i u početku ne morate osjećati nikakve simptome.
English: Cartridge: Glass Type I.
Croatian: Uložak: Staklo tip I.
English: Never inject more than one dose in the same day.
Croatian: Nikad ne primjenjujte više od jedne doze na dan.
English: Please read the information in these boxes carefully - they contain important information for you.
Croatian: Molimo da pažljivo pročitate informacije u ovim okvirima - oni sadrže za Vas važne podatke.
English: Reconstituted solution: 28 days
Croatian: Rekonstituirana otopina: 28 dana
English: • At the request of the European Medicines Agency
Croatian: • Na traženje Europske agencija za lijekove
English: Parathyroid hormone N=1341
Croatian: Paratiroidni hormon N=1341
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
English: Use each needle only once.
Croatian: Svaku iglu upotrijebite samo jedanput.
English: Always use Preotact exactly as your doctor has told you.
Croatian: Uvijek primijenite Preotact onako kako Vam je rekao Vaš liječnik.
English: • pain in arms and legs (extremities),
Croatian: • bol u rukama i nogama (ekstremitetima),
English: Date of latest renewal: 24.04.2011
Croatian: Datum posljednje obnove odobrenja: 24.04.2011.
English: Ask your pharmacist how to throw away any medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako zbrinuti lijekove koje više ne koristite.
English: Do not push it back until you are instructed to do so in this leaflet.
Croatian: Ne gurajte ga natrag dok u uputama ne naučite kako.
English: Preotact should not be used in children or adolescents under 18 years old.
Croatian: Preotact ne smiju koristiti djeca ili adolescenti u dobi do 18 godina.
English: • Some medic may come out - this is normal.
Croatian: • Malo lijeka može izaći vani - ovo je normalno.
English: • Let it sit for about one minute until the medicine is completely mixed.
Croatian: • Pričekajte oko jedne minute da se lijek potpuno izmiješa.
English: There is no specific antidote for Preotact.
Croatian: Nema specifičnog antidota za Preotact.
English: “click”
Croatian: “klik”
English: This means that it is essentially “sodium-free”.
Croatian: To znači da se smatra da ne sadrži natrij („sodium free“).
English: Until further clinical data becomes available the recommended treatment time of 24 months should not be exceeded.
Croatian: Do dostupnosti novih kliničkih podataka, preporučeno vrijeme liječenja od 24 mjeseca se ne smije prekoračiti.
English: • Check that the medicine is clear.
Croatian: • Provjerite je li lijek bistar.
English: Keep using Preotact for as long as your doctor prescribes it for you - normally no longer than 24 months.
Croatian: Koristite Preotact onoliko dugo koliko Vam je propisao liječnik - uobičajeno ne duže od 24 mjeseca.
English: Like all medicines, Preotact can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Preotact može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada ne bacajte lijekove u otpadne vode ili kućni otpad.
English: If you use more Preotact than you should
Croatian: Ako ste primijenili više Preotacta nego što ste morali
English: You can choose to continue and take your daily injection now or store the pre-filled pen in the refrigerator, as described under ‘Practical information', at the end of the Instructions for use.
Croatian: Sad možete nastaviti i primijeniti svoju dnevnu injekciju, ili napunjenu brizgalicu spremiti u hladnjak kao što je opisano u “Praktičnim informacijama” na kraju ovih Uputa za uporabu.
English: To prevent one or more new vertebral fractures, 48 women had to be treated for a median of 18 months for the total population.
Croatian: Za spriječavanje jednog ili više novih prijeloma kralježaka bilo je potrebno u ukupnoj populaciji liječiti 48 žena tijekom prošječno 18 mjeseci.
English: Consequently, no interaction with other medicinal products would be anticipated and no specific drug-drug interactions studies were performed.
Croatian: Zbog toga se ne očekuju interakcije sa drugim lijekovima i nisu provedena specifična ispitivanja interakcija.
English: Therefore if any blood samples are taken from a patient for monitoring of calcium levels, this should be done at least 20 hours after the most recent injection.
Croatian: Dakle, ako se uzima uzorak krvi od bolesnika kako bi se pratila razina kalcija, ovo mora biti napravljeno najmanje 20 sati nakon zadnje injekcije.
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Croatian: Zbog razlike u fiziologiji kostiju miševa i ljudi, kliničko značenje ovog otkrića je vjerojatno neznatno.