FrancophonIA/ELRC3.0 huggingface dataset:
English: During a 21 week observation period the incidence of new cases of S. uberis clinical mastitis was 50% lower in the group of 277 cattle vaccinated with Ubac compared to the group of 303 cattle given placebo (dummy treatment) (6.1% versus 12.2%).
Croatian: Tijekom razdoblja promatranja pojavnosti novih slučajeva kliničkog mastitisa uzrokovanog bakterijom S. uberis u trajanju od 21 tjedna, pojavnost mastitisa bila je 50 % niža u skupini od 277 grla cijepljenih cjepivom Ubac u usporedbi sa skupinom od 303 grla koja su primala placebo (prividno liječenje) (6,1 % u odnosu na 12,2 %).
English: Why is Ubac authorised in the EU?
Croatian: Zašto je Ubac odobren u EU-u?
English: Protection starts about 36 days after the second injection and lasts for the first 5 months of lactation (milk production).
Croatian: Imunost započinje približno 36 dana nakon druge doze i traje približno prvih pet mjeseci laktacije (proizvodnje mlijeka).
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Croatian: Kojih se mjera opreza mora pridržavati osoba koja primjenjuje VMP ili dolazi u kontakt sa životinjom?
English: The first injection is given at about 60 days before the expected calving date followed by a second injection given at least 3 weeks before the expected calving date.
Croatian: Prva injekcija daje se oko 60 dana prije očekivanog termina teljenja, nakon čega slijedi druga injekcija, koja se daje najmanje tri tjedna prije očekivanog termina teljenja.
English: An overview of Ubac and why it is authorised in the EU
Croatian: Pregled VMP-a Ubac i zašto je odobren u EU-u
English: The European Medicines Agency decided that Ubac's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi VMP-a Ubac nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
English: Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis).
Croatian: Ubac se također koristi za smanjivanje broja somatskih stanica u mlijeku, što predstavlja mjerilo mastitisa bez vidljivih znakova (subklinički mastitis).
English: Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production.
Croatian: Ubac je cjepivo koje se primjenjuje u krava i junica (ženskih goveda koja se još nisu telila) radi ublažavanja kliničkog mastitisa (infekcija vimena s vidljivim znakovima u mlijeku ili vimenu) uzrokovanog bakterijom Streptococcus uberis, koji može smanjiti proizvodnju mlijeka.
English: The most common side effects with UBAC (which may affect more than 1 in 10 animals) are a shortlived increase in rectal temperature of around 1 - 2 ºC within 24 hours of injection and a local injection site swelling of more than 5 cm in diameter.
Croatian: Najčešće nuspojave cjepiva Ubac (mogu se javiti u više od 1 na 10 životinja) jesu kratkotrajno povećanje rektalne temperature od oko 1 - 2 ºC u roku od 24 sata od injektiranja te oteklina na mjestu primjene injekcije promjera većeg od 5 cm.
English: Ubac is available as an injection and can only be obtained with a prescription.
Croatian: Ubac dostupno je kao injekcija i izdaje se samo na veterinarski recept.
English: A field study involved 6 farms with a history of S. uberis clinical mastitis and recently confirmed presence of S. uberis infection.
Croatian: Terensko ispitivanje obuhvaćalo je šest poljoprivrednih gospodarstava na kojima se pojavljivao klinički mastitis uzrokovan bakterijom S. uberis i na kojima je nedavno potvrđena prisutnost infekcije bakterijom S. uberis.
English: Ubac is given as a course of 3 injections into the neck muscles, alternating sides of the neck.
Croatian: Ubac se daje u obliku triju injekcija u vratne mišiće, naizmjenično na obje strane vrata.
English: When Ubac is given to cattle, the animals' immune system recognises the active susbstance as ‘foreign' and makes antibodies against it.
Croatian: Ubac, imunosni sustav životinje prepoznaje djelatnu tvar kao „strano tijelo” i proizvodi antitijela protiv njega.
English: Ubac is a vaccine.
Croatian: Ubac je cjepivo.
English: The active substance in Ubac is obtained from the sticky substances that the S. uberis bacteria produce to protect themselves and attach to surfaces (known as biofilm adhesion components).
Croatian: Djelatna tvar u VMP-u Ubac dobiva se iz ljepljivih tvari koje bakterije S. uberis proizvode kako bi se zaštitile i pričvrstile na površine (adhezijske sastavnice biofilma).
English: The package leaflet should be shown to the doctor.
Croatian: Liječniku je potrebno pokazati uputu o VMP-u.
English: What benefits of Ubac have been shown in studies?
Croatian: Koje su koristi VMP-a Ubac utvrđene u ispitivanjima?
English: For more information about using Ubac, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Ubac pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616.
Croatian: Ubac sadrži djelatnu tvar naziva lipoteikoična kiselina iz adhezijske sastavnice biofilma, koja se dobiva iz ljepljivog filma koji proizvodi bakterija Streptococcus uberis, soj
English: How does Ubac work?
Croatian: Kako djeluje Ubac?
English: How is Ubac used?
Croatian: Kako se Ubac koristi?
English: Ubac received a marketing authorisation valid throughout the EU on 26 July 2018.
Croatian: Za VMP Ubac izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od
English: Subcutaneous use pre-filled pen 1 ml (50 mg/ml) 4 pre-filled pens
Croatian: 0,51 ml (50 mg/ml) 4 napunjene štrcaljke
English: Subcutaneous use pre-filled syringe 1 ml (50 mg/ml) 12 (3 x 4) pre-filled syringes (multipack)
Croatian: 12 (3 x 4) napunjene brizgalice (višestruko pakiranje)
English: The effects were sustained for up to seven years.
Croatian: Djelovanje se zadržalo i do sedam godina.
English: Siklos is taken once a day, preferably in the morning before breakfast.
Croatian: Siklos se uzima jednom dnevno, po mogućnosti ujutro prije doručka.
English: This summary was last updated in 03-2014.
Croatian: Sažetak je posljednji put ažuriran: 03.2014.
English: It is available as tablets (100 and 1,000 mg).
Croatian: Dostupan je u obliku tableta (100 i 1.000 mg).
English: The number of cases of acute chest syndrome also fell by 25 to 33%.
Croatian: Broj slučajeva s akutnim sindromom prsa smanjio se također za 25 do 33%.
English: The 1,000 mg tablet has special score lines so that it can be easily divided into four equal parts.
Croatian: Tablete od 1.000 mg imaju posebne razdjelne linije tako da se lako mogu podijeliti na četiri jednaka dijela.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Siklos on 29 June 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Siklos vrijedi na prostoru Europske unije od 29. lipnja 2007.
English: What measures are being taken to ensure the safe and effective use of Siklos?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Siklos?
English: There were also fewer admissions into hospital, and fewer days spent in hospital.
Croatian: Zabilježen je također i manji broj prijema u bolnicu, te kraći boravak u bolnici.
English: Patients who do not respond to this dose or who have side effects may need to stop or suspend treatment.
Croatian: Bolesnici koji ne reagiraju na ovu dozu ili koji imaju nuspojave moraju prekinuti ili zaustaviti liječenje.
English: Blood cell counts normally return to normal within two weeks of stopping Siklos treatment.
Croatian: Broj krvnih stanica najčešće se vraća u normalu u roku od dva tjedna nakon prestanka liječenja lijekom Siklos.
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer.
Croatian: Hidroksikarbamid, koji je bio poznat pod nazivom hidroksiureja, dostupan je u Europskoj uniji (EU) već nekoliko desetljeća za liječenje drugih bolesti, uključujući i pojedine tipove raka.
English: Patients had fewer vaso-occlusive crises when treated with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults.
Croatian: Bolesnici su imali manje vazookluzivnih kriza prilikom liječenja lijekom Siklos nego prije liječenja, pri čemu je učestalost pala između 66% i 80% u djece i odraslih.
English: The dose is adjusted according to the response to treatment, with the usual dose being between 15 and 30 mg per kilogram body weight per day.
Croatian: Doza se prilagođava ovisno o odgovoru na liječenje, pri čemu uobičajena doza iznosi između 15 i 30 mg po kilogramu tjelesne težine po danu.
English: Other information about Siklos
Croatian: Ostale informacije o lijeku Siklos
English: The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen, back or chest.
Croatian: Ispitivanja su usporedila broj vazookluzivnih kriza prije i nakon liječenja lijekom Siklos, koje su definirane bolnim epizodama koje su uključivale ruke, noge, abdomen, leđa ili prsa.
English: This reduces the risk of blood vessels becoming blocked.
Croatian: To smanjuje rizik od blokade krvnih žila.
English: Siklos is a medicine that contains the active substance hydroxycarbamide.
Croatian: Siklos je lijek koji sadrži djelatnu tvar hidroksikarbamid.
English: The starting dose is usually 15 mg per kilogram body weight, using the most appropriate tablet strengths (100 or 1,000 mg) to make up the dose, breaking up the 1,000-mg tablet in quarters (250 mg) if needed.
Croatian: Početna doza najčešće iznosi 15 mg po kilogramu tjelesne težine, uz primjenu najprimjerenije jačine tableta (100 ili 1.000 mg) kako bi se pripremila doza, pri čemu se tableta od 1.000 mg može razlomiti na četvrtine (250 mg) ako je potrebno.
English: Doses of up to 35 mg per kilogram body weight per day can be used in exceptional cases, as long as the patient's blood is monitored for side effects.
Croatian: Doze do 35 mg po kilogramu tjelesne težine po danu mogu se primjenjivati u iznimnim slučajevima, te ukoliko se krv bolesnika prati kako bi se uočile nuspojave.
English: Because the number of patients with sickle cell syndrome is low, the disease is considered ‘rare', and Siklos was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2003.
Croatian: Budući da je broj bolesnika sa sindromom srpastih stanica mali, dotična se bolest smatra „rijetkom”, a Siklos se označava kao lijek siroče (lijek za liječenje rijetkih bolesti) od 9. srpnja 2003.
English: In the study comparing Siklos with placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year).
Croatian: U ispitivanju u kojem je uspoređen lijek Siklos s placebom u odraslih osoba, zabilježen je manji broj vazookluzivnih kriza u bolesnika koji su uzimali lijek Siklos (2,5 krize na godinu) u odnosu na one koji su uzimali placebo (4,5 krize na godinu).
English: Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome.
Croatian: Budući da je hidroksikarbamid dobro poznata tvar koja se već koristi u drugim lijekovima, tvrtka je upotrijebila informacije iz znanstvene literature kao bi podržala primjenu lijeka Siklos u odraslih osoba i djece oboljelih od sindroma srpastih stanica.
English: In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children with sickle cell syndrome who were treated with Siklos for up to seven years.
Croatian: Posebice su dostavili dokaz o djelotvornosti lijeka Siklos iz 11 objavljenih ispitivanja koja su obuhvatila 378 djece te iz tri nacionalna registra informacije o 155 djece oboljele od sindroma srpastih stanica koji su liječeni lijekom Siklos u razdoblju do sedam godina.
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 Siklos.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Siklos.
English: A risk management plan has been developed to ensure that Siklos is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Siklos.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Siklos možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Siklos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Siklos pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Patients taking Siklos should have blood tests before and regularly during treatment, to check their blood cell counts and also to monitor their kidneys and liver.
Croatian: U bolesnika koji uzimaju lijek Siklos potrebno je provesti krvne pretrage prije i redovito nakon liječenja kako bi se provjerio njihov broj krvnih stanica te se također pratilo stanje njihovih bubrega i jetre.
English: It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos.
Croatian: Također su dostavili dokaze iz jednog ispitivanja u 299 odraslih osoba, u kojih je djelovanje lijeka Siklos uspoređeno s djelovanjem placeba (prividnog liječenja), kao i rezultate drugih ispitivanja koja su obuhvatila 430 odraslih osoba i jedan nacionalan registar informacija o 123 odrasle osobe liječene lijekom Siklos.
English: The medicine can only be obtained with a prescription.
Croatian: Ovaj se lijek izdaje isključivo na liječnički recept.
English: The full EPAR for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Siklos nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X ray.
Croatian: Ove krize mogu uključivati akutni sindrom prsa, po život opasno stanje pri kojem bolesnik osjeća iznenadnu bol u prsima te ima groznicu, otežano disanje ili znakove tekućine u plućima na rendgenskoj snimci.
English: It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ.
Croatian: Koristi se za sprječavanje rekurentnih, bolnih vazookluzivnih kriza koje nastupaju kada se krvne žile zablokiraju abnormalnim crvenim krvnim stanicama, čime se ograničava protok krvi do organa.
English: The CHMP decided that Siklos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Siklos nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The most common side effect with Siklos (seen in more than one patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells).
Croatian: Najčešće nuspojave lijeka Siklos (kod više od 1 na 10 osoba) su supresija koštane srži, što uzrokuje neutropeniju (niske razine neutrofila, tipa bijelih krvnih stanica), retikulokitopeniju (niske razine retikulokita, tipa nezrelih crvenih krvnih stanica) i makrokitozu (povećanje crvenih krvnih stanica).
English: This is a summary of the European public assessment report (EPAR) for Siklos.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Siklos.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Siklos, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Siklos uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is the risk associated with Siklos?
Croatian: Koji su rizici povezani s lijekom Siklos?
English: Siklos must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts.
Croatian: Siklos se ne smije primjenjivati u osoba koje imaju ozbiljne problem s bubrezima ili jetrom, odnosno koji imaju opasno nizak broj krvnih stanica.
English: Although the precise way that it works in this disease is not understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell syndrome.
Croatian: Iako nije u potpunosti jasno kako lijek točno djeluje na ovu bolest, hidroksikarbamid može smanjiti broj stanica koje kruže u krvi te spriječiti promjenu oblika crvenih krvnih stanica u bolesnika sa sindromom srpastih stanica.
English: The dose of Siklos should be reduced in patients who have mild or moderate problems with their kidneys.
Croatian: Doza lijeka Siklos mora se smanjiti u bolesnika koji imaju blage ili umjerene probleme s bubrezima.
English: Treatment with Siklos should be started by a doctor who has experience in the management of sickle cell syndrome.
Croatian: Terapiju lijekom Siklos treba propisati liječnik s iskustvom u liječenju sindroma srpastih stanica.
English: The active substance in Siklos, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Croatian: Djelatna tvar u lijeku Siklos, hidroksikarbamid, blokira rast i reprodukciju pojedinih stanica, poput stanica krvi.
English: What benefit has Siklos shown during the studies?
Croatian: Koje su koristi lijeka Siklos dokazane u ispitivanjima?
English: Siklos hydroxycarbamide
Croatian: Siklos hidroksikarbamid
English: Siklos, reversible oligospermia or azoospermia (reduced or absent production of healthy sperm) is also very commonly seen.
Croatian: U muškaraca liječenih lijekom Siklos vrlo se često mogla uočiti reverzibilna oligospermija ili azoospermija (smanjeni broj ili izostanak stvaranja zdrave sperme).
English: Siklos is used in adults, adolescents and children over two years of age who have sickle cell syndrome, a genetic disease where the red blood cells become rigid and sticky, and change from being discshaped to being crescent-shaped (like a sickle).
Croatian: Siklos se primjenjuje u odraslih osoba, adolescenata i djece starije od dvije godine koji boluju od sindroma srpastih stanica, genetske bolesti koja uzrokuje krutost i ljepljivost crvenih krvnih stanica kao i promjenu oblika iz diska u krestu (poput srpa).
English: What is Siklos?
Croatian: Što je Siklos?
English: Breast-feeding must be stopped while taking Siklos.
Croatian: Prilikom uzimanja lijeka Siklos, dojenje se mora prekinuti.
English: Why has Siklos been approved?
Croatian: Zašto je lijek Siklos odobren?
English: How does Siklos work?
Croatian: Kako djeluje Siklos?
English: What is Siklos used for?
Croatian: Za što se Siklos koristi?
English: For the full list of all side effects reported with Siklos, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Siklos potražite u uputi o lijeku.
English: How is Siklos used?
Croatian: Kako se Siklos koristi?
English: How has Siklos been studied?
Croatian: Kako je Siklos ispitivan?
English: Please carefully follow the instructions of the veterinarian.
Croatian: Molimo pažljivo slijedite upute veterinara.
English: Symptoms were reversible.
Croatian: Simptomi su bili reverzibilni.
English: The tablet can be divided into equal halves.
Croatian: Tableta se može podijeliti na jednake polovice.
English: The recommended dose should not be exceeded.
Croatian: Preporučena se doza ne smije premašiti.
English: The active substance in Inflacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Croatian: Djelatna tvar u Inflacam je dopuštena tvar kao je opisano u tablici 1 dodatka Uredbe Komisije (EU) br. 37/2010:
English: The precision of the syringe is not suitable for the treatment of cats below 1 kg.
Croatian: Preciznost štrcaljke nije pogodna za liječenje mačaka manjih od 1 kg.
English: Dose scheme for the maintenance dose:
Croatian: Shema doziranja za dozu održavanja:
English: The metabolism in horses was not investigated.
Croatian: Metabolizam u konja nije istraživan.
English: Bottle (HDPE)
Croatian: Boca (HDPE)
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tom veterinarsko-medicinskom proizvodu.
English: Accidental self-injection may give rise to pain.
Croatian: Nehotično samoinjektiranje može prouzročiti bol.
English: Therapeutic classification
Croatian: Terapijska klasifikacija
English: Inflacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Croatian: Inflacam tablete za žvakanje mogu se davati s hranom ili bez nje, aromatizirane su i većina pasa ih uzima dragovoljno.
English: During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Croatian: Za vrijeme anestezije, nadzor i terapiju tekućinom treba uzeti u obzir kao standardnu praksu.
English: See also section 4.7.
Croatian: Vidi dio 4.7.
English: However, no data have been generated in horses.
Croatian: Međutim, za konje nema podataka.
English: In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
Croatian: U slučaju miješanja proizvoda s hranom, treba ga dodati u manju količinu hrane, prije hranjenja.
English: Reduction of post-operative pain (over a period of 24 hours):
Croatian: Smanjenje poslijeoperacijskog bola (u razdoblju od 24 sata):
English: Maximum number of piercings is 42 for all presentations.
Croatian: Najveći broj uboda je 42 za sva odobrena pakovanja.