FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a do klanja životinje i korištenja mesa za prehranu ljudi.
English: Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Croatian: Zaštita je trajala 23 tjedna nakon cijepljenja za PCV2 i bakteriju Mycoplasma hyopneumoniae.
English: For further information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o VMP-u.
English: The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination.
Croatian: Ispitivanja su pokazala da je cjepivo postiglo potpuni učinak protiv virusa PCV2 i bakterije Mycoplasma hyopneumonia tri tjedna nakon cijepljenja.
English: Suvaxyn Circo+MH RTU, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear.
Croatian: Cjepivo Suvaxyn Circo+MH RTU, koje je dostupno u obliku tekućine za injekciju, daje se svinjama starijima od tri tjedna u obliku jedne injekcije u mišić vrata iza uha.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Suvaxyn Circo+MH RTU na snazi u Europskoj uniji od 15. siječnja 2015.
English: Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
Croatian: Suvaxyn Circo+MH RTU je veterinarsko cjepivo koje se upotrebljava kako bi se svinje starije od tri tjedna zaštitilo od infekcije cirkovirusom svinja i bakterijom Mycoplasma hyopneumoniae.
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Suvaxyn Circo+MH RTU.
English: It is not intended to provide practical advice on how to use Suvaxyn Circo+MH RTU.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Suvaxyn Circo+MH RTU.
English: For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Suvaxyn Circo+MH RTU vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What is Suvaxyn Circo+MH RTU and what is it used for?
Croatian: Što je Suvaxyn Circo+MH RTU i za što se koristi?
English: For more information about treatment with Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Suvaxyn Circo+MH RTU vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Croatian: Suvaxyn Circo+MH RTU sadržava inaktivirane (umrtvljene) djelatne tvari dobivene od cirkovirusa svinja tipa 2 i bakterije
English: What are the risks associated with Suvaxyn Circo+MH RTU?
Croatian: Koji su rizici povezani s VMP Suvaxyn Circo+MH RTU?
English: For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni VMP-a Suvaxyn Circo+MH RTU potražite u uputi o VMP-u.
English: Suvaxyn Circo+MH RTU is a vaccine.
Croatian: Suvaxyn Circo+MH RTU je cjepivo.
English: Suvaxyn Circo+MH RTU is only available on prescription.
Croatian: Suvaxyn Circo+MH RTU izdaje se samo na veterinarski recept.
English: Why is Suvaxyn Circo+MH RTU approved?
Croatian: Zašto je VMP Suvaxyn Circo+MH RTU odobren?
English: Other information about Suvaxyn Circo+MH RTU?
Croatian: Ostale informacije o VMP Suvaxyn Circo+MH RTU?
English: The field studies showed that Suvaxyn Circo+MH RTU reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
Croatian: smanjena viremija virusa PCV2 (prisutnost virusa u krvi) u odnosu na svinje kojima je dano lažno cjepivo.
English: How is Suvaxyn Circo+MH RTU used?
Croatian: Kako se Suvaxyn Circo+MH RTU koristi?
English: What benefits of Suvaxyn Circo+MH RTU have been shown in studies?
Croatian: Koje su koristi VMP Suvaxyn Circo+MH RTU utvrđene u ispitivanjima?
English: How does Suvaxyn Circo+MH RTU work?
Croatian: Kako Suvaxyn Circo+MH RTU djeluje?
English: Having assessed all the available data, the PRAC concluded that:
Croatian: Nakon procjene svih dostupnih podataka, PRAC je zaključio da:
English: Scientific conclusions and grounds for the conclusions
Croatian: Znanstveni zaključci i razlozi za zaključke
English: No further amendments were considered necessary.
Croatian: Smatrano je da daljnje dopune nisu potrebne.
English: After an initially higher risk during the first year of use, the risk decreases to a constant lower level.
Croatian: Nakon početnog povišenog rizika tijekom prve godine primjene, rizik se smanjuje na kontinuirano nisku razinu.
English: “The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”
Croatian: „Povišeni rizik od VTE-a tijekom razdoblja nakon porođaja treba se uzeti u obzir prilikom ponovnog počinjanja terapije [zaštićen naziv lijeka] (vidi dio 4.2 i 4.4).”
English: There was no evidence for differences between these medicinal products in terms of beneficial effects.
Croatian: Također nema dokaza razlika među ovim proizvodima u smislu blagotvornog djelovanja.
English: For comparison, in women who are not using CHCs (no-users) and who are not pregnant, there will be around 2 cases of VTE each year per 10,000 women.
Croatian: Za usporedbu, u žena koje ne koriste KHK-ove (nekorisnici) i koje nisu trudne javila su se otprilike 2 slučaja VTE-a svake godine na 10.000 žena.
English: Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women.
Croatian: Moguća je pogrešna dijagnoza s obzirom da se TE manifestira difuznim simptomima i vrlo je rijetka u populaciji zdravih mladih žena.
English: Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Croatian: Ukupno promatrano, venska tromboembolija (VTE) može biti smrtonosna u 1-2% slučajeva.
English: 1 - Overall summary of the scientific evaluation
Croatian: 1 - Cjelokupan sažetak znanstvene ocjene
English: For dienogest and nomegestrol studies are on going and results will be submitted when available.
Croatian: Ispitivanja dienogesta i nomegestrola su u tijeku, a rezultati će biti dostavljeni čim postanu dostupni.
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should be re-evaluated periodically.
Croatian: Uzimajući u obzir da se faktori rizika od VTE-a mijenjaju tijekom vremena, PRAC je napomenuo da se individualni rizik mora periodički ponovno ocjenjivati.
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Croatian: Postoje također i određeni nasljedni trombofilijski nedostaci koji povećavaju ovaj rizik.
English: These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).
Croatian: Ovi se lijekovi kombiniraju s varirajućim dozama etinilestradiola (EE) ili s estradiolom (E2).
English: The risk of VTE is also higher in the presence of intrinsic risk factors.
Croatian: Rizik od VTE-a također je povišen u slučaju prisutnosti intrinzičnih faktora rizika.
English: When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE).
Croatian: Ukoliko se dijagnoza ne postavi i liječene se ne započne, ili se jasni simptomi tromboze ne mogu identificirati, ugrušak se može pomaknuti prema gore do pluća (pulmonalna embolija, PE) ili mozga (cerebralna embolija, CE).
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk of thromboembolism.
Croatian: Daljnje promjene u informacijama o lijekovima doprinose boljem informiranju zdravstvenih djelatnika i žena o riziku od tromboembolije.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Croatian: • je PRAC razmotrio postupak u skladu sa člankom 31. Direktive 2001/83/EC lijekove koji sadrže kombinirane hormonalne kontraceptive.
English: 2 - Detailed explanation for the differences from the PRAC recommendation
Croatian: 2 - Detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: Therefore, on the basis of the available evidence, the PRAC acknowledged that the benefits associated with using a CHC far outweigh the risk of serious adverse events in most women.
Croatian: Stoga, na temelju dostupnih dokaza, PRAC potvrđuje da koristi povezane s primjenom KHK-a uvelike nadmašuju rizik ozbiljnih nuspojava u većine žena.
English: In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC.
Croatian: U veljači 2013. godine, Francuska agencija za lijekove (ANSM) pokrenula je postupak upućivanja u skladu sa člankom 31. Direktive 2001/83/EZ na temelju toga da je omjer koristi i rizika ovih kombiniranih hormonalnih kontraceptiva postao nepovoljan u aktualnoj odobrenoj indikaciji zbog povećanog rizika od tromboembolije (TE), te je stoga u interesu Unije da predmet uputi PRAC-u.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for Evra, Ioa and Zoely should be varied.
Croatian: Nakon razmatranja preporuke PRAC-a od dana 10. listopada 2013. godine u skladu sa člankom 107k(3) Direktive 2001/83/EZ, CHMP je mišljenja da odobrenja za stavljanje u promet lijekova Evra, Ioa i Zoely trebaju biti izmijenjena.
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis, DVT).
Croatian: Tromboembolijski događaji su nuspojave koje najčešće nastupaju u veni noge (duboka venska tromboza, DVT).
English: The risk of VTE with CHCs differs among products depending on the type of progestogen they contain.
Croatian: Rizik od VTE-a sa KHK-ovima razlikuje se među proizvodima ovisno o tipu progestogena kojeg sadrže.
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijekova u promet
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between CHCs in their relative risk of ATE.
Croatian: Poznato je da je rizik od arterijske tromboembolije (ATE-a) (infarkta miokarda, moždanog udara) također povišen s primjenom KHK-a, no nema dokaza u razlikama između KHK-ova u njihovom relativnom riziku od ATE-a.
English: The following sentence was therefore inserted in the Pregnancy section of the SmPC:
Croatian: Stoga je sljedeća rečenica umetnuta u dio Trudnoća Sažetka opisa svojstava lijeka:
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Croatian: Dokazano je da je rizik od VTE-a najveći tijekom prve godine u kojoj žena počne uzimati hormonalne kontraceptive ili kada ponovno počne uzimati lijekove nakon razdoblja neprimjene od najmanje mjesec dana (Dinger et al,. 2007, Sidney et al., 2013).
English: Many studies have evaluated the risk of VTE and its complications (deep vein thrombosis, pulmonary embolism) among users of different CHCs.
Croatian: Mnoga su ispitivanja ocijenila rizik od VTE-a i njegovih komplikacija (duboke venske tromboze, pulmonalne embolije) u korisnika različitih KHK-ova.
English: Based on the totality of the available data the PRAC concluded that the risk of VTE differs between products - with the lower risk products being those containing the progestogens levonorgestrel, norethisterone and norgestimate.
Croatian: Na temelju ukupnosti dostupnih podataka, PRAC je zaključio da se rizik od VTE-a razlikuje od proizvoda do proizvoda - proizvodi manjeg rizika su oni koji sadrže progestogene levonorgestrel, noretisteron i norgestimat.
English: The current review confirmed the previous understanding that the level of VTE risk with CHCs containing low dose of ethinylestradiol (ethinylestradiol <50µg) is small, but differences in the VTE risk were observed between most products depending on the type of progestogen they contain.
Croatian: Aktualnim je pregledom potvrđeno prethodno viđenje da postoji mala razina rizika od VTE-a s KHK-ovima koji sadrže malu dozu etinilestradiola (etinilestradiol <50µg), no razlike u riziku od VTE-a uočene među proizvodima ovise o tipu progestogena kojeg sadrže.
English: However, the PRAC recommended routine risk minimisation measures, including a strengthening of the wording of the product information to reflect the current knowledge of risks (incidence rate) as well as symptoms for VTE and ATE and clarifying the situations for which these products are contraindicated.
Croatian: No, PRAC je preporučio rutinske mjere minimiziranja rizika, uključujući odabir oštrije formulacije informacija o proizvodu kako bi se prikazala aktualna saznanja o rizicima (stopa incidencije) kao i simptomi za VTE i ATE te pojasnile situacije za koje su ovi proizvodi kontraindicirani.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation CHMP Members' Divergent Positions
Croatian: Dodatak IV Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a pro-thrombotic state).
Croatian: Poznati faktori rizika od VTE-a uključuju anamnezu VTE-a, trudnoću, traumu, kirurški zahvat, imobilizaciju (primjerice nakon kirurškog zahvata ili dugih letova), pretilost i pušenje (odnosno sve situacije pro-trombotskog stanja).
English: • The estimated incidence of risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of VTE per 10,000 women who use these medicines.
Croatian: • je procijenjena incidencija rizika najmanja sa KHK-ovima koji sadrže progestogene levonorgestrel, norgestimat i noretisteron: procjenjuje se da će svake godine biti između 5 i 7 slučajeva VTE-a na 10.000 žena koje koriste ove lijekove.
English: For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products.
Croatian: Za pojedine lijekove (primjerice klormadinon, dienogest, nomegestrol) trenutno nema dovoljno podataka kako bi se utvrdio rizik u usporedbi s lijekovima manjeg rizika.
English: • The PRAC is of the opinion that the benefits of combined hormonal contraceptive containing medicinal products continue to outweigh the risks in the indication of contraception.
Croatian: • je PRAC mišljenja da koristi lijekova koji sadrže kombinirane hormonalne kontraceptive i dalje nadmašuju rizike u indikaciji kontracepcije.
English: Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.
Croatian: Nadalje, preporuča se proaktivno informiranje kako bi se komunicirao ishod predmetnog pregleda i naglasio rizik od tromboembolija putem izravne komunikacije zdravstvenim djelatnicima (pisma liječnicima).
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.
Croatian: PRAC je potvrdio poznati rizik od tromboembolije lijekova koji sadrže kombinirane hormonalne kontraceptive i preporučio je jasno označavanje simptoma kombiniranih tromboembolijskih događaja kao i faktora rizika od tromboembolije.
English: However, the CHMP considered that the section on Fertility, pregnancy and lactation of the SmPC should be amended to reflect the increased risk of VTE in the post-partum period, to ensure consistency with the warning section of the SmPC.
Croatian: No, CHMP smatra da se dio o Plodnosti, trudnoći i laktaciji Sažetka opisa svojstava lijeka treba nadopuniti tako da navodi povećani rizik od VTE-a u razdoblju nakon porođaja kako bi se osigurala konzistentnost s dijelom o upozorenjima Sažetka opisa svojstava lijeka.
English: • The PRAC considered that in view of the currently available safety data, the benefit-risk balance of combined hormonal contraceptives is favourable, subject to restrictions, warnings and other changes to the product information.
Croatian: • je PRAC zaključio da je, s obzirom na trenutno dostupne podatke o sigurnosti primjene, omjer koristi i rizika kombiniranih hormonalnih kontraceptiva povoljan, što je predmetom ograničenja, upozorenja i drugih izmjena u informacijama o proizvodu.
English: In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Croatian: Nadalje, nositelji odobrenja za stavljanje u promet lijeka klormadinon trebaju provesti ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet.
English: The CHMP considered the below PRAC recommendation dated 10 October 2013 with regards to combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol.
Croatian: CHMP je razmotrio niže navedenu preporuku PRAC-a od dana 10. listopada 2013. s obzirom na kombinirane hormoralne kontraceptive koji sadrže klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ili nomegestrol.
English: • The estimated incidence of risk is also higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women.
Croatian: • je procijenjena incidencija rizika također veća s progestogenima gestodenom, desogestrelom, drospirenonom, i to između 9 i 12 slučajeva godišnje na 10.000 žena.
English: • The estimated incidence of risk is higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women.
Croatian: • je procijenjena incidencija rizika veća s progestogenima etonogestrelom i norelgestrominom, i to između 6 i 12 slučajeva godišnje na 10.000 žena.
English: • For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
Croatian: • dostupni podaci za KHK-ove koji sadrže klormadinon, dienogest i nomegestrol nisu dostatni kako bi se saznalo u kojoj mjeri je rizik usporediv s drugim KHK-ovima.
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors, in patients after major surgery with prolonged immobilisation, patients who smoke and patients with history or hereditary predisposition of thromboembolism.
Croatian: Ovi lijekovi moraju biti, posebice, kontraindicirani u bolesnika s višestrukim faktorima rizika, u bolesnika nakon većih kirurških zahvata s kasnijom imobilizacijom, bolesnika koji puše i bolesnika s anamnezom ili nasljednom predispozicijom za tromboemboliju.
English: The revised Summary of Product Characteristics (SmPC) and Package Leaflet (PL) are set out in the respective annexes I and IIIB for Evra, Ioa and Zoely.
Croatian: Revidirani Sažetak opisa svojstava lijeka i Uputa o lijeku navedeni su u odgovarajućim dodatcima I i IIIB za lijekove Evra, Ioa i Zoely.
English: Medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol are authorised in the European Union as combined hormonal contraceptives (CHCs).
Croatian: Lijekovi koji sadrže klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ili nomegestrol odobreni su za stavljanje u promet u Europskoj uniji kao kombinirani hormonalni kontraceptivi (KHK-ovi).
English: For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
Croatian: U slučaju klormadinona ovo će se istražiti putem ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet, kako je obrazloženo niže u tekstu.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the ones containing levonorgestrel.
Croatian: • je PRAC zaključio da su daljnji podaci potrebni za kombinirane hormonalne kontraceptive koji sadrže klormadinon i nametnuo je provođenje ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (PASS) kako bi se ocijenio relativan rizik od tromboembolijskih događaja zato što su ovi lijekovi uspoređeni s onima koji sadrže levonorgestrel.
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrelcontaining medicinal products.
Croatian: Nadalje, PRAC je nametnuo provođenje ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet kako bi se bolje okarakterizirao rizik od tromboembolijskih događaja zbog klormadinona u usporedbi s lijekovima koji sadrže levonorgestrel.
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, as well as the views of an ad hoc expert meeting on the efficacy and safety of the CHCs, in particular in relation to the risk of thromboembolism.
Croatian: PRAC je pregledao sve dostupne podatke iz kliničkih ispitivanja, farmakoepidemioloških ispitivanja, objavljene literature, iskustva nakon što su lijekovi stavljeni u promet, uključujući odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet putem pisanih i oralnih pojašnjenja kao i stavove ad hoc stručne skupine o djelotvornosti i sigurnosti KHK-ova, posebice s obzirom na rizik od tromboembolije.