FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vizamyl pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.
Croatian: Vizamyl je radiofarmaceutik (lijek koji sadrži male količine radioaktivne tvari) koji sadrži djelatnu tvar flutemetamol (18F).
English: Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias.
Croatian: Vizamyl se izdaje samo na liječnički recept, a PET snimanje s lijekom Vizamyl trebali bi indicirati zdravstveni djelatnici s iskustvom u kliničkom upravljanju bolesnicima s bolestima poput Alzheimerove bolesti i drugih demencija.
English: For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vizamyl potražite u uputi o lijeku.
English: Not all strengths may be available in every country.
Croatian: Možda nisu sve jačine dostupne u svim zemljama.
English: This overview was last updated in September 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u rujnu 2018.
English: Econor is an antibiotic.
Croatian: Econor je antibiotik.
English: Further information on Econor can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/Econor.
Croatian: Više informacija o VMP-u Econor nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPARs/Econor.
English: Econor had a positive effect in terms of reducing the severity of disease and improving its outcome.
Croatian: Econor pozitivno djeluje u smislu ublažavanja ozbiljnosti bolesti i poboljšanja njezina ishoda.
English: It works by blocking the production of proteins inside the bacteria and thereby stopping their growth.
Croatian: Djeluje inhibirajući proizvodnju proteina unutar bakterija i tako zaustavlja njihov rast.
English: The dose and length of treatment depend on the condition, the animal for which it is being used and its bodyweight.
Croatian: Doza i trajanje liječenja ovise o stanju, životinji za koju se primjenjuje i njezinoj tjelesnoj težini.
English: Gloves should be worn when handling the product.
Croatian: Prilikom rukovanja proizvodom treba nositi rukavice.
English: However, infection with Mycoplasma hyopneumoniae was not eliminated.
Croatian: Međutim, infekcija bakterijom Mycoplasma hypopneumoniae nije eliminirana.
English: Valnemulin is active against a range of bacteria including those responsible for the diseases listed above.
Croatian: Valnemulin je djelotvoran protiv niza bakterija, uključujući i one odgovorne za prethodno navedene bolesti.
English: Econor received a marketing authorisation valid throughout the European Union on 12 March 1999.
Croatian: VMP Econor dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 12. ožujka 1999.
English: Econor improves the health and reduces weight loss of the treated pigs, but may not completely eliminate the bacteria that cause lung infection.
Croatian: Econor poboljšava zdravlje i smanjuje gubitak težine u liječenih svinja, ali možda neće do kraja ukloniti bakterije koje uzrokuju infekciju pluća.
English: The most common side effects in pigs are pyrexia (high temperature) and a lack of appetite; in severe cases, they might become uncoordinated and remain lying down.
Croatian: Najčešće nuspojave u svinja su pireksija (visoka temperatura) i gubitak apetita; u teškim slučajevima mogući su nekoordinirani pokreti i zavaljenost unazad (ležanje).
English: The European Medicines Agency decided that Econor'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 Econor nadmašuju s njim povezane rizike te da on može biti odobren za primjenu u Europskoj uniji.
English: This is a disease associated with changes in the normal balance of bacteria in the gut which allow growth of clostridia, bacteria that produce a toxin which paralyses the intestine.
Croatian: Ta je bolest povezana s promjenama normalne ravnoteže bakterija u crijevima, što omogućuje rast klostridija, bakterija koje proizvode toksin koji paralizira crijeva.
English: What is Econor and what is it used for?
Croatian: Što je Econor i za što se primjenjuje?
English: Other information about Econor
Croatian: Ostale informacije o VMP-u Econor
English: The active substance of Econor is valnemulin, an antibiotic of the pleuromutilin group.
Croatian: Djelatna tvar VMP-a Econor je valnemulin, antibiotik iz skupine pleuromutilina.
English: Extreme care should, therefore, be taken when using Econor in pigs of Scandinavian origin.
Croatian: Stoga je potreban izniman oprez kad se Econor primjenjuje u svinja skandinavskog podrijetla.
English: The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.
Croatian: Oralni prašak u hranu za svinje dodaje vlasnik svinja i upotrebljava ga za liječenje pojedinačnih svinja.
English: People known to be allergic to valnemulin should use Econor with caution.
Croatian: Osobe za koje je poznato da su alergične na valnemulin trebaju oprezno primjenjivati VMP Econor.
English: An overview of Econor and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Econor i zašto je odobren u EU-u
English: ERE commonly occurs in commercial rabbit farms during the post-weaning fattening period.
Croatian: ERE se često javlja na komercijalnim farmama kunića tijekom razdoblja tova nakon prestanka sisanja.
English: In pigs, serious adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.
Croatian: Ozbiljne nuspojave u svinja nakon primjene VMP-a Econor uglavnom su povezane s pasminama i mješancima danskog i/ili švedskog landrasa.
English: Why is Econor authorised in the EU?
Croatian: Zašto je VMP Econor odobren u EU-u?
English: What are the risks associated with Econor?
Croatian: Koji su rizici povezani s VMP-om Econor?
English: It is used in pigs to treat or prevent a number of infectious diseases that are caused by bacteria and affect the lungs (i.e. swine enzootic pneumonia) or the gut (i.e. swine dysentery, porcine proliferative enteropathy or porcine colonic spirochaetosis).
Croatian: Primjenjuje se u svinja za liječenje i sprječavanje brojnih zaraznih bolesti koje su prouzročene bakterijama i koje zahvaćaju pluća (tj. svinjske enzootske pneumonije) ili crijeva (tj. svinjske dizenterije, svinjske proliferativne enteropatije ili svinjske kolonske spirohetoze).
English: In rabbits, Econor is used to reduce mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Croatian: Econor se primjenjuje u kunića za smanjenje smrtnosti tijekom izbijanja epizootske enteropatije kunića (ERE).
English: If Econor is accidentally consumed by a person, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju da osoba slučajno proguta VMP Econor, potrebno je odmah potražiti savjet liječnika i pokazati mu uputu o VMP-u ili etiketu.
English: Econor is available as a premix for medicated feeding stuff for pigs (10% and 50%) and rabbits (10%), and as an oral powder for pigs (10%).
Croatian: VMP Econor dostupan je u obliku premiksa za ljekovitu hranu za svinje (10 % i 50 %) i kuniće (10 %) te u obliku oralnog praška za svinje (10 %).
English: The withdrawal period is the time required after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a i prije klanja životinje i korištenja mesa za prehranu ljudi.
English: Econor premix is mixed into pig or rabbit feed by an authorised feed mill and the resulting “medicated feeding stuff” is then distributed to the farmer to treat a large number of pigs or rabbits.
Croatian: Premiks VMP-a Econor dodaje se u hranu za svinje ili kuniće u ovlaštenoj mješaonici stočne hrane, a tako dobivena „ljekovita hrana” potom se dostavlja uzgajivačima za potrebe liječenja velikog broja svinja ili kunića.
English: The withdrawal period for meat and offal from pigs treated with Econor is one day and for meat and offal from rabbits treated with Econor it is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Karencija za meso i iznutrice svinja liječenih VMP-om Econor je jedan dan, a za meso i iznutrice kunića liječenih VMP-om Econor je „nula” dana, što znači da ne postoji obvezno vrijeme čekanja.
English: If side effects occur, Econor-containing food should be immediately removed; severely affected pigs should be moved to clean, dry pens and given appropriate treatment.
Croatian: Ako dođe do nuspojava, stočnu hranu koja sadržava VMP Econor treba odmah ukloniti, a jako pogođene svinje treba izdvojiti u čiste i suhe torove te primijeniti odgovarajuće liječenje.
English: How does Econor work?
Croatian: Kako djeluje Econor?
English: In a study involving 1,152 weaned rabbits, after an outbreak of ERE, treatment with Econor for 21 days reduced mortality during a 4 week period from 23% in untreated rabbits to 11% in those given 20 mg valnemulin per kg of feed, and about 8% in those given 35 mg valnemulin per kg feed.
Croatian: U ispitivanju kojim su bila obuhvaćena 1 152 kunića koja su prestala sisati, nakon izbijanja epizootske enteropatije primjenom VMP-a Econor tijekom 21 dana smanjena je smrtnost tijekom četverotjednog razdoblja s 23 % u neliječenih kunića na 11 % u onih koji su primali 20 mg valnemulina po kg hrane za životinje te na oko 8 % u onih koji su primali 35 mg valnemulina po kg hrane za životinje.
English: Rabbits must not be given overdoses of Econor as this may disturb gastrointestinal flora (gut bacteria) leading to the development of enterotoxaemia (infection of the gut).
Croatian: Kunićima se ne smije dati prekomjerna doza VMP-a Econor jer to može poremetiti crijevnu floru (crijevne bakterije) i prouzročiti razvoj enterotaksemije.
English: Tympanism (distension of the abdomen) is more frequent in rabbits treated with Econor than in untreated rabbits.
Croatian: Timpanizam (nadimanje trbuha) češći je u kunića liječenih VMP-om Econor nego u onih koji nisu liječeni.
English: Econor can only be obtained with a prescription.
Croatian: Econor se izdaje samo na veterinarski recept.
English: What benefits of Econor have been shown in studies?
Croatian: Koje su koristi od VMP-a Econor utvrđene u ispitivanjima?
English: Econor at a dose of 1 to 1.5 mg valnemulin per kg bodyweight per day (i.e. 25 mg per kg feed) effectively prevented the development of the disease.
Croatian: Primjenom VMP-a Econor u dozi od 1 do 1,5 mg po kg tjelesne težine dnevno (tj. 25 mg po kg stočne hrane) učinkovito je spriječen razvoj bolesti.
English: For further information about using Econor, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Dodatne informacije o primjeni VMP-a Econor pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: How is Econor used?
Croatian: Kako se Econor primjenjuje?
English: In prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1 to 1.5 mg valnemulin per kg bodyweight daily (i.e. 25 mg per kg feed) was effective in controlling the clinical signs and prevented weight loss caused by the disease in untreated pigs.
Croatian: U sprječavanju svinjske kolonske spirohetoze (kolitisa), primjenom VMP-a Econor u stočnoj hrani u dozi od 1 do 1,5 mg valnemulina po kg tjelesne težine dnevno (tj. 25 mg po kg stočne hrane) uspješno su kontrolirani klinički znakovi bolesti i spriječen je gubitak težine prouzročen bolešću u neliječenih svinja.
English: For treatment of porcine proliferative enteropathy (ileitis), Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for 10 days improved the clinical condition of the pigs, reduced diarrhoea and reduced weight loss.
Croatian: Za liječenje svinjske proliferativne enteropatije (ileitisa), primjenom VMP-a Econor u stočnoj hrani u dozi od 3 do 4 mg valnemulina po kg tjelesne težine dnevno (tj. 75 mg po kg stočne hrane) tijekom 10 dana došlo je do poboljšanja kliničkog stanja svinja, ublažen je proljev i smanjen gubitak težine.
English: In studies in the treatment and prevention of swine dysentery, Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for at least 7 days successfully treated swine dysentery.
Croatian: U ispitivanjima liječenja i sprječavanja svinjske dizenterije, primjenom VMP-a Econor u stočnoj hrani u dozi od 3 do 4 mg valnemulina po kg tjelesne težine dnevno (tj. 75 mg po kg stočne hrane) tijekom najmanje 7 dana uspješno je liječena svinjska dizenterija.
English: In studies in the treatment and prevention of swine enzootic pneumonia, Econor in feed at a dose of 10 to 12 mg valnemulin per kg bodyweight daily (i.e. 200 mg per kg feed) for up to 4 weeks reduced lung lesions, improved clinical signs and pig growth rates compared to untreated pigs.
Croatian: U ispitivanjima liječenja i sprječavanja svinjske enzootske pneumonije, primjenom VMP-a Econor u stočnoj hrani u dozi od 10 do 12 mg valnemulina po kg tjelesne težine dnevno (tj. 200 mg po kg stočne hrane) tijekom najviše 4 tjedna ublaženi su klinički znakovi bolesti i povećana stopa rasta svinja u usporedbi s neliječenim svinjama.
English: Econor contains the active substance valnemulin.
Croatian: Econor sadržava djelatnu tvar valnemulin.
English: Direct contact with the skin, mouth and nose should be avoided when mixing Econor and handling the final feed containing the medicine.
Croatian: Prilikom miješanja VMP-a Econor i rukovanja gotovom hranom za životinje koja ga sadržava treba izbjegavati izravan kontakt s kožom, ustima i nosom.
English: ‘Advanced' means that the cancer has started to spread;
Croatian: „Uznapredovalo” znači da se rak počeo širiti;
English: It is given as an infusion lasting 30 to 60 minutes.
Croatian: Primjenjuje se kao infuzija u trajanju od 30 do 60 minuta.
English: Further information on Torisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Torisel nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This overview was last updated in 03-2018.
Croatian: Pregled informacija posljednji je put ažuriran u 03. 2018.
English: The main measure of effectiveness was how long patients lived without the disease getting worse.
Croatian: Glavno mjerilo djelotvornosti bilo je razdoblje preživljenja bez pogoršanja bolesti.
English: Torisel received a marketing authorisation valid throughout the EU on 19 November 2007.
Croatian: Lijek Torisel dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 19. studenoga 2007.
English: What is Torisel and what is it used for?
Croatian: Što je Torisel i za što se koristi?
English: Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel.
Croatian: Bolesnicima se daje injekcija antihistaminika radi sprječavanja alergijske reakcije otprilike 30 minuta prije svake doze lijeka Torisel.
English: Some side effects can be managed by interrupting treatment or reducing the dose.
Croatian: Pojedine nuspojave mogu se kontrolirati prekidom terapije ili smanjenjem doze.
English: What measures are being taken to ensure the safe and effective use of Torisel?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Torisel?
English: Each patient received one of two doses of Torisel or the most appropriate alternative cancer medicines chosen by the investigator.
Croatian: Svaki je bolesnik primio jednu od dviju doza lijeka Torisel ili najprikladniji alternativni lijek protiv raka prema odabiru ispitivača.
English: Other information about Torisel
Croatian: Ostale informacije o lijeku Torisel
English: What are the risks associated with Torisel?
Croatian: Koji su rizici povezani s lijekom Torisel?
English: Why is Torisel authorised in the EU?
Croatian: Zašto je lijek Torisel odobren u EU-u?
English: Side effects reported with Torisel are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Torisel pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renal cell carcinoma: 6 April 2006, expired November 2017; mantle cell lymphoma: 6 November 2006).
Croatian: Dodatne informacije o statusu lijeka za rijetku bolest nalaze se na internetskim stranicama Europske agencije za lijekove: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (karcinom bubrežnih stanica: 6. travnja 2006., status istekao u studenome 2017. (limfom plaštenih stanica: 6. studenoga 2006.).
English: These diseases are rare, and Torisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Croatian: Te su bolesti rijetke, a Torisel je dobio status „lijeka za rijetku bolest” na različite datume.
English: Torisel must be given under the supervision of a doctor who has experience in the use of cancer medicines.
Croatian: Torisel se mora primjenjivati pod nadzorom liječnika s iskustvom u primjeni lijekova protiv raka.
English: As for all medicines, data on the use of Torisel are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Torisel kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Torisel have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Torisel nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.
Croatian: Budući da je mTOR uključen u kontrolu diobe stanica, Torisel sprječava diobu stanica raka te usporava njegov rast i širenje.
English: • mantle cell lymphoma (a cancer of B cells, a type of white blood cell).
Croatian: • limfoma plaštenih stanica (raka B-stanica, vrste bijelih krvnih stanica).
English: The European Medicines Agency decided that Torisel'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 lijeka Torisel nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.
Croatian: Bolesnici koji su primali lijek Torisel u prosjeku su živjeli 4,8 mjeseci bez pogoršanja bolesti u usporedbi s 1,9 mjeseci u bolesnika koji su primali alternativnu terapiju.
English: Torisel is a medicine used to treat patients with the following types of cancer:
Croatian: Torisel je lijek za liječenje bolesnika koji boluju od sljedećih vrsta raka:
English: For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.
Croatian: Preporučena doza za limfom plaštenih stanica je 175 mg jednom tjedno u trajanju od tri tjedna, nakon čeka slijede tjedne doze od 75 mg.
English: Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.
Croatian: Torisel se primjenjuje u odraslih osoba ako se limfom ponovno pojavio nakon prethodne terapije ili ako druge terapije nisu djelovale.
English: For more information about using Torisel, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Torisel pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Treatment with Torisel should continue until the medicine is no longer working or causes unacceptable side effects.
Croatian: Liječenje lijekom Torisel treba nastaviti sve dok lijek ne prestane djelovati ili do nastanka neprihvatljivih nuspojava lijeka.
English: Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa.
Croatian: Bolesnici su liječeni dozom od 25 mg lijeka Torisel, interferonom alfa ili dozom od 15 mg lijeka Torisel u kombinaciji s interferonom alfa.
English: Torisel must not be used in patients with mantle cell lymphoma who have moderate or severe problems with their liver.
Croatian: Lijek Torisel ne smije se primjenjivati u bolesnika s limfomom plaštenih stanica koji imaju umjerene ili ozbiljne probleme s jetrom.
English: For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood.
Croatian: Za rak bubrežnih stanica preporučena doza lijeka Torisel je 25 mg jednom tjedno, ali se doza od 10 mg preporučuje u bolesnika koji imaju ozbiljne probleme s jetrom i visoku razinu trombocita u krvi.
English: The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).
Croatian: Najčešće nuspojave lijeka Torisel (koje se mogu javiti u više od 1 na 5 osoba) uključuju infekcije, pneumoniju (upalu pluća), trombocitopeniju (nizak broj krvnih pločica), anemiju (nizak broj crvenih krvnih stanica), smanjeni apetit, hiperglikemiju (visoku razinu šećera u krvi), hiperkolesterolemiju (visoku razinu kolesterola u krvi), disgeuziju (poremećaje okusa), poteškoće pri disanju, krvarenje iz nosa, kašalj, povraćanje, stomatitis (upalu sluznice usne šupljine), proljev, mučninu (slabost), osip, pruritus (svrbež), edem (oticanje), umor, slabost, vrućicu i upalu sluznice (upalu vlažnih površina tijela).
English: How is Torisel used?
Croatian: Kako se Torisel koristi?
English: This complex then blocks mTOR.
Croatian: Taj kompleks zatim onemogućuje djelovanje enzima mTOR.
English: In the body, temsirolimus attaches to a protein inside cells to make a ‘complex'.
Croatian: Temsirolimus se u tijelu veže za bjelančevine u stanicama kako bi stvorio „kompleks”.
English: Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
Croatian: Lijek Torisel ne smiju primjenjivati osobe preosjetljive (alergične) na temsirolimus, njegove metabolite (tvari na koje se raščlanjuje), uključujući sirolimus (lijek koji se primjenjuje za sprječavanje odbacivanja presađenih bubrega), na polisorbat 80 ili bilo koji drugi sastojak lijeka.