FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of patients who have to stop treatment because of side effects appears low and the side effects can be managed with appropriate measures.
Croatian: Broj bolesnika koji moraju prekinuti terapiju uslijed nuspojava bio je mali, a nuspojave je bilo moguće kontrolirati primjenom odgovarajućih mjera.
English: How does Unituxin work?
Croatian: Kako djeluje Unituxin?
English: What benefits of Unituxin have been shown in studies?
Croatian: Koje su koristi lijeka Unituxin utvrđene u ispitivanjima?
English: Because pain is a common side of Unituxin treatment, patients are also given pain killers.
Croatian: Budući da je bol učestala nuspojava terapije lijekom Unituxin, bolesnicima također treba dati analgetike.
English: For practical information about using Unituxin, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Unituxin pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Unituxin contains the active substance dinutuximab.
Croatian: Unituxin sadrži djelatnu tvar dinutuksimab.
English: How is Unituxin used?
Croatian: Kako se Unituxin koristi?
English: The patient also receives 3 other medicines: isotretinoin,
Croatian: Bolesnici također primaju 3 druga lijeka: izotretinoin, GM-CSF i interleukin-2.
English: This will help protect the pig against the disease.
Croatian: To pomaže u zaštiti svinja od bolesti.
English: In the future, the immune system will be able to react against the virus more quickly.
Croatian: Stoga će u budućnosti, imunosni sustav moći brže reagirati protiv virusa.
English: This overview was last updated in April 2019.
Croatian: Pregled informacija posljednji je put ažuriran u travnju 2019.
English: Further information on Suvaxyn PRRS MLV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
Croatian: Više informacija o VMP-u Suvaxyn PRRS MLV nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv
English: The most common side effects with Suvaxyn PRRS MLV are a short lived increase in body temperature (0.5-0.8 °C on average), which may affect more than 1 in 10 pigs within 4 days of vaccination, and local reactions in the form of swellings which resolve without treatment in 5 to 9 days.
Croatian: Najčešće nuspojave VMP-a Suvaxyn PRRS MLV su kratkotrajni porast tjelesne temperature (u prosjeku 0,5 - 0,8 °C ) koji se može javiti u više od 1 na 10 svinja unutar 4 dana nakon cijepljenja, te lokalne reakcije u obliku oticanja koja nestanu bez liječenja u roku od 5 do 9 dana.
English: The withdrawal period for meat from pigs treated with Suvaxyn PRRS MLV is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Suvaxyn PRRS MLV iznosi „nula” dana, drugim riječima, nema obveznog razdoblja čekanja.
English: In pregnant gilts and sows with no prior exposure to PRRS virus, Suvaxyn PRRS MLV must not be used in the second half of pregnancy because the virus in the vaccine may cross the placenta and affect the birth rate.
Croatian: U gravidnih nazimica i krmača bez prethodne izloženosti virusu PRRS Suvaxyn PRRS MLV ne smije se koristiti u drugoj polovici graviditeta jer virus iz cjepiva može proći kroz posteljicu i utjecati na stopu rođenja.
English: Mass vaccination can take place in herds in which presence of European PRRS virus is known.
Croatian: Masovno cijepljenje može se provesti u uzgojima u kojima je utvrđena prisutnost europskog PRRS virusa.
English: Gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets) are given a single injection before introduction into the sow herd, about 4 weeks before breeding, and a booster injection every 6 months.
Croatian: Nazimicama (ženkama svinja koje se još nisu oprasile) i krmačama (ženkama svinja koje su se oprasile) daje se jedna injekcije prije uvođenja u uzgoj, zatim približno 4 tjedna prije rasploda i jedna doza za docjepljivanje svakih 6 mjeseci.
English: Suvaxyn PRRS MLV received a marketing authorisation valid throughout the EU on 24 August 2017.
Croatian: VMP Suvaxyn PRRS MLV dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 24. kolovoza 2017.
English: Two studies were conducted in female pigs, one which showed that single vaccination of female pigs 10 to 11 weeks before mating protected them against disease when exposed to the virus 26 weeks after vaccination.
Croatian: U ženki svinja provedena su dva ispitivanja; u jednom od njih pokazalo se da je jedno cijepljenje 10 do 11 tjedana prije rasploda zaštitilo svinje od bolesti kada su virusu bile izložene 26 tjedana nakon cijepljenja.
English: Suvaxyn PRRS MLV contains a modified strain of live PRRS virus, strain 96V198, that has been weakened so that it does not cause disease.
Croatian: Suvaxyn PRRS MLV sadrži modificirani soj živog virusa PRRS, soj 96V198, koji je oslabljen tako da ne uzrokuje bolest.
English: Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS).
Croatian: Suvaxyn PRRS MLV je veterinarsko cjepivo koje se koristi za zaštitu svinja od respiratornog i reproduktivnog sindroma (PRRS).
English: This viral disease of pigs may result in lowered farrowing (birth) rates, increase in abortions, stillborn, mummified as well as weak live born piglets and deaths.
Croatian: Virusna bolest svinja može rezultirati nižim stopama prasenja, većim brojem pobačaja i mrtvorođene prasadi, mumifikacijom ploda, a također slabošću i uginućem oprašene prasadi.
English: When a pig is given the vaccine, the pig's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Croatian: imunosni sustav svinje prepoznaje virus kao „strano tijelo” i proizvodi protutijela na virus.
English: Suvaxyn PRRS MLV must not be used in herds where European PRRS virus has not been detected by reliable diagnostic methods.
Croatian: Suvaxyn PRRS MLV ne smije se koristiti u stadima u kojima pouzdanim dijagnostičkim metodama nije utvrđen europski PRRS virus.
English: Protection starts to be effective 21 days after vaccination and lasts for 26 weeks after vaccination.
Croatian: Cjepivo postaje učinkovito 21 dan nakon cijepljenja, a zaštita traje do 26 tjedana nakon cijepljenja.
English: Suvaxyn PRRS MLV is a vaccine.
Croatian: Suvaxyn PRRS MLV je cjepivo.
English: The second study in sows showed that a booster vaccination 6 months after the initial vaccination, with mating performed 4 months after the second vaccination, gave protection for 7 months.
Croatian: Drugo ispitivanje provedeno u krmača pokazalo je da se docjepljivanjem 6 mjeseci nakon prvog cijepljenja, s rasplodom 4 mjeseca nakon drugog cijepljenja, postigla zaštita koja je trajala sedam mjeseci.
English: There may also be disease of the airways which can lead to high death rates in suckling and weaned pigs.
Croatian: Može postojati i bolest dišnih puteva, koja može dovesti do visokih stopa smrtnosti u prasadi za vrijeme razdoblja sisanja te nakon prestanka sisanja.
English: The European Medicines Agency decided that Suvaxyn PRRS MLV'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 Suvaxyn PRRS MLV nadmašuju s njim povezane rizike te da VMP može biti odobren za primjenu u Europskoj uniji.
English: Other information about Suvaxyn PRRS MLV
Croatian: Ostale informacije o VMP-u Suvaxyn PRRS MLV
English: What is Suvaxyn PRRS MLV and what is it used for?
Croatian: Što je Suvaxyn PRRS MLV i za što se koristi?
English: A study in piglets showed the vaccine starts to be effective 21 days after vaccination and four studies in piglets showed protection lasts up to 26 weeks.
Croatian: Ispitivanje u prasadi pokazalo je da cjepivo postaje učinkovito 21 dan nakon cijepljenja, a četiri ispitivanja provedena u prasadi pokazala su da zaštita traje do 26 tjedana.
English: Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription.
Croatian: Suvaxyn PRRS MLV je dostupan kao liofilizat (sušeni zamrznuti pelet) i otapalo za pripremu suspenzije za injekciju te se izdaje samo na veterinarski recept.
English: Suvaxyn PRRS MLV contains a weakened strain of PRRS virus.
Croatian: Suvaxyn PRRS MLV sadrži oslabljeni soj PRRS virusa.
English: Why is Suvaxyn PRRS MLV authorised in the EU?
Croatian: Zašto je VMP Suvaxyn PRRS MLV odobren u EU-u?
English: An overview of Suvaxyn PRRS MLV and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Suvaxyn PRRS MLV i zašto je odobren u EU-u
English: Suvaxyn PRRS MLV is given as a single injection from 1 day of age to pigs for fattening.
Croatian: Suvaxyn PRRS MLV primjenjuje se kao jedna injekcija od prvog dana života tovnih svinja.
English: Suvaxyn PRRS MLV must also not be used in boars producing semen, as PRRS virus can be shed in semen.
Croatian: Suvaxyn PRRS MLV ne smije se primjenjivati na veprovima koji proizvode sjeme jer se PRRS virus može raspršiti u sjemenu.
English: For further information about using Suvaxyn PRRS MLV, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Dodatne informacije o primjeni VMP-a Suvaxyn PRRS MLV pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: For the full list of all side effects and restrictions with Suvaxyn PRRS MLV, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni VMP-a Suvaxyn PRRS MLV potražite u uputi o VMP-u.
English: What are the risks associated with Suvaxyn PRRS MLV?
Croatian: Koji su rizici povezani s VMP-om Suvaxyn PRRS MLV?
English: The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies.
Croatian: Učinkovitost VMP-a Suvaxyn PRRS MLV potkrijepljena je laboratorijskim ispitivanjima.
English: How does Suvaxyn PRRS MLV work?
Croatian: Kako djeluje Suvaxyn PRRS MLV?
English: What benefits of Suvaxyn PRRS MLV have been shown in studies?
Croatian: Koje su koristi od VMP-a Suvaxyn PRRS MLV utvrđene u ispitivanjima?
English: How is Suvaxyn PRRS MLV used?
Croatian: Kako se Suvaxyn PRRS MLV koristi?
English: The main studies supporting intravaginal application are Studies SCO 5109 and SCO 5174.
Croatian: Glavna ispitivanja koja podržavaju intravaginalnu primjenu su ispitivanja SCO 5109 i SCO 5174.
English: In addition the restriction to 4 weeks use of these products is justified by the clinical data currently available.
Croatian: Nadalje, ograničenje na 4 tjedna primjene ovih proizvoda opravdano je kliničkim podacima koji su trenutno dostupni.
English: In addition, the clear reference to the patient population (postmenopausal women) intended to treat should be added.
Croatian: Nadalje, treba dodati jasnu referencu za populaciju bolesnika (žene u postmenopauzi) koji se trebaju liječiti.
English: The CHMP therefore recommended the deletion of this indication from the product information.
Croatian: Stoga, CHMP preporuča brisanje ove indikacije iz informacija o proizvodu.
English: Linoladiol N and Linoladiol HN are approved via national procedures in different member states.
Croatian: Linoladiol N i Linoladiol HN odobreni su putem nacionalnih postupaka u različitim državama članicama.
English: Clear information should be reflected in the posology section.
Croatian: Jasne informacije trebaju biti navedene u poglavlju o doziranju.
English: In terms of pharmacovigilance data, a total of 11 cases were reported including spontaneous reports and literature cases.
Croatian: U smislu farmakovigilancijskih podataka, prijavljeno je ukupno 11 slučajeva, uključujući spontane prijave i
English: The peak concentration of estradiol was reached 6 hours after application (median).
Croatian: Vršna koncentracija estradiola dosegnuta je 6 sati nakon primjene (medijan).
English: Vigilance is required for possible systemic side effects and skin atrophy.
Croatian: Vigilancija je potrebna za moguće sistemske nuspojave i atrofiju kože.
English: Decreases in FSH and LH were also observed, further reflecting the existence of relevant systemic exposure.
Croatian: Uočeno je i smanjenje razine FSH i LH koje nadalje odražava relevantno sistemsko izlaganje.
English: The adjusted mean Cδmax (92.2 pg/ml) amounted to 89% of the total Cmax.
Croatian: Prilagođena srednja vrijednost Cδmax (92,2 pg/ml) iznosila je 89% ukupnog Cmax.
English: However due to no specific safety reports to-date and the known lack of sensitivity of spontaneous reporting, only the well-known risks of systemic HRT are to be expected.
Croatian: No, zbog izostanka specifičnih izvješća o sigurnoj prijavi do današnjeg dana i poznatog nedostatka osjetljivosti spontanih prijava, mogu se očekivati samo dobro poznati rizici sistemskog HRB-a.
English: The CHMP carried out a new assessment of the available efficacy data in the concerned indication.
Croatian: CHMP je proveo novu ocjenu dostupnih podataka o djelotvornosti za predmetnu indikaciju.
English: In order to enforce this short duration of use, the CHMP requested withdrawal of the pack sizes of 100 g in all EU Members States where the products are authorised, as this large pack size of cream is considered redundant under the new recommendations for the duration of use.
Croatian: S ciljem primjene ovog kratkog razdoblja korištenja, CHMP je zatražio povlačenje pakiranja od 100g u svim državama članicama u kojima je proizvod odobren, budući da se ovo veliko pakiranje kreme smatra suvišnim sukladno novim preporukama za trajanje primjene.
English: Following the adoption of the CHMP opinion and recommendations during the December 2013 CHMP meeting, a re-examination request on Linoladiol N medicinal product only was received from one MAH.
Croatian: Nakon usvajanja mišljenja CHMP-a i preporuka donesenih tijekom sastanka CHMP-a održanog u prosincu 2013., zahtjev za ponovni pregled lijeka Linoladiol N zaprimljen je samo od jednog nositelja odobrenja.
English: The mean value of AUC0-36 (1285.2 pg/ml·h) and Cmax (103.5 pg/ml) indicate systemic exposure to estradiol from the intravaginal cream.
Croatian: Srednja vrijednost AUC0-36 (1285,2 pg/ml·h) i Cmax (103,5 pg/ml) indikatorna je za sistemsko izlaganje estradiolu iz intavaginalne kreme.
English: Furthermore, due to the content of the corticosteroid prednisolone, use of Linoladiol HN is recommended only for short-term therapy (up to four weeks).
Croatian: Nadalje, uslijed sadržaja kortikosteroidnog prednizolona primjena lijeka Linoladiol HN preporučena je samo za kratkoročne terapije (u trajanju do četiri tjedna).
English: There were two main scientific points of disagreement with the CHMP opinion addressed in the MAH's grounds for re-examination.
Croatian: Postojale su dvije glavne točke neslaganja s mišljenjem CHMP-a koje je nositelj odobrenja iznio u svojim razlozima za ponovni pregled.
English: The authors state that in postmenopausal women reporting vaginal symptoms as their only complaint, these symptoms can be safely and effectively managed with low-dose oestrogen therapy, which reduces the risks associated with long-term systemic hormone therapy.
Croatian: Autori navode da u žena u postmenopauzi koje su prijavile vaginalne simptome kao svoju jedinu tegobu, ovim se simptomima može sigurno i učinkovito upravljati terapijom niske doze estrogena, koja smanjuje rizike povezane s dugoročnom sistemskom hormonskom terapijom.
English: Germany was concerned that these products containing estradiol, which are indicated only for local use, exhibit high blood concentration upon application, which is seen only with products authorised for systemic use.
Croatian: Njemačka je izrazila zabrinutost da proizvodi koji sadrže estradiol, a indicirani su za topikalnu primjenu, iskazuju visoke koncentracije u krvi nakon primjene, što je uočeno samo s proizvodima odobrenima za sistemsku primjenu.
English: In addition, the CHMP considered that the maximum duration of treatment should continue to be restricted to four weeks, and clear information that treatment beyond four weeks is not recommended should be reflected in the posology section.
Croatian: Osim toga, CHMP je zaključio da maksimalno trajanje liječenja treba i dalje biti ograničeno na četiri tjedna, te jasne informacije da se liječenje dulje od četiri tjedan ne preporuča treba navesti u dijelu o doziranju.
English: With regards to the use of Linoladiol HN for the treatment of lichen sclerosus genitalis, the CHMP noted that according to the current clinical knowledge on the treatment of this condition, estradiol is not a treatment option.
Croatian: Vezano uz primjenu lijeka Linoladiol HN za liječenje lichen sclerosus genitalis, CHMP je napomenuo da u skladu s aktualnim kliničkim znanjem o liječenju ovog stanja, estradiol nije opcija za liječenje.
English: High dose estradiol products such as Linoladiol N are not specifically considered in these recommendations.
Croatian: Lijekovi koji sadrže visoke doze estradiola poput lijeka Linoladiol N, nisu posebno razmotreni u tim preporukama.
English: In particular, the CHMP re-assessed the pharmacokinetic data available, as well as the comparison to existing treatments in consultation to the international guidelines.
Croatian: Posebice, CHMP je ponovno ocijenio dostupne farmakokinetičke podatke te je iste usporedio s postojećim liječenjem konzultirajući se međunarodnim smjernicama.
English: Based on study SCO 5109, it is concluded that twice weekly estradiol serum levels similar to those reached with systemic hormonal replacement therapy (HRT) are observed.
Croatian: Na temelju ispitivanja SCO 5109, zaključeno je da su uočene razine estradiola u serumu primijenjenog dva puta tjedno slične onima postignutima sa sistemskom hormonskom nadomjesnom terapijom (HRT).
English: 2 Rees et al. EMAS clinical guide: Low-dose vaginal estrogens for postmenopausal vaginal atrophy.
Croatian: EMAS clinical guide: Low-dose vaginal estrogens for postmenopausal vaginal atrophy.
English: The primary objective of the study was to estimate the extent of estradiol exposure after application of the test formulation Linoladiol N.
Croatian: Primarni cilj ispitivanja bio je utvrditi razmjer izlaganja estradiola nakon primjene testne formulacije lijeka Linoladiol N.
English: In addition, although Linoladiol HN contains a lower (half) concentration of oestrogen than Linoladiol N, the CHMP considered that the product information should still reflect adequate warnings with regards to risks of hormone replacement therapy.
Croatian: Nadalje, iako Linoladiol HN sadrži manje (polovicu) koncentracije estrogena u odnosu na Linoladiol N, CHMP je zaključio da informacije o proizvodu i dalje moraju prikazivati odgovarajuća upozorenja u vezi s rizicima hormonske nadomjesne terapije.
English: However, no conclusions regarding endometrial safety can be drawn based on post-marketing data, due to the low number of total reported cases for Linoladiol N and the confounded cases reporting endometrial events.
Croatian: No, zaključci u vezi s endometrijalnom sigurnosti ne mogu se donijeti na temelju podataka nakon stavljanja lijeka u promet zbog malog broja ukupno prijavljenih slučajeva za lijek Linoladiol N i zbunjujućih slučajeva koji prijavljuju endometrijalne događaje.
English: Restrictions, warnings and other changes to the product information were proposed to reflect current clinical knowledge on the safety of HRT especially regarding thromboembolism, and breast and endometrial cancer.
Croatian: Ograničenja, upozorenja i druge promjene u informacijama o proizvodu predložene su kako bi prikazale aktualno kliničko znanje o sigurnosti HRB-a, posebice u vezi s tromboembolijom i rakom dojki i endometrijalnim rakom.
English: Comparison of pharmacokinetic data with other locally applied medicinal products was made.
Croatian: Provedena je usporedba farmakokinetičkih podataka s drugim lokalno primijenjenim lijekovima.
English: The CHMP conclusions on these points raised in the MAH's grounds are given below.
Croatian: Zaključci CHMP o ovim točkama koje je naveo nositelj odobrenja navedeni su niže u tekstu.
English: In terms of the PK data, systemic levels of estradiol are of interest due to well-known safety concerns.
Croatian: U smislu FK podataka, sistemske razine estradiola su od značaja uslijed dobro poznatih pitanja sigurne primjene.
English: In particular, the treatment applies to vaginal atrophy in postmenopausal women, duration of treatment should be limited to four weeks and the product is intended for intravaginal administration only.
Croatian: Posebice, liječenje se primjenjuje na vaginalnu atrofiju u žena u postmenopauzi, trajanje liječenja treba ograničiti na četiri tjedana, a proizvod je predviđen samo za intravaginalnu primjenu.
English: Thus, they disagreed with some of the amendments proposed by the CHMP to be implemented in the product information.
Croatian: Stoga su se on nije složio da neke izmjene i dopune koje je predložio CHMP budu navedene u informacijama o lijeku.
English: • The Committee 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, on the efficacy and safety these medicinal products for topical use.
Croatian: • Povjerenstvo je pregledalo sve dostupne podatke iz svih kliničkih ispitivanja, farmakoepidemiološka ispitivanja, objavljenu literaturu, iskustvo prikupljeno nakon stavljanja proizvoda u promet, uključujući i odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet (nositelja odobrenja) na pismeno i u oralnim pojašnjenjima, o djelotvornosti sigurnoj primjeni ovih lijekova za topikalnu primjenu.
English: Clinical guidelines2,3 propose the use of topical oestrogens after lack of/inadequate response to nonhormonal vaginal lubricants / moisturisers, and other non-hormonal interventions.
Croatian: Kliničke smjernice2,3 traže topikalne primjene estrogena nakon nedostatka/ili neprimjerenog odgovora na nehormonalne vaginalne lubrikante / ovlaživači i druge nehormonalne intervencije.
English: Overall benefit-risk balance
Croatian: Cjelokupna ocjena koristi i rizika
English: The CHMP agreed with the MAH that not only dose, but also absorption and systemic concentrations of topically administered estradiol are of interest.
Croatian: CHMP je suglasan s nositeljem odobrenja da nije od interesa samo doza, već također apsorpcija i sistemske koncentracije topikalno primijenjenog estradiola.
English: The Committee accepted the MAH's argument that although current clinical guidelines differentiate between systemic and topical oestrogen treatments and clearly topical treatments are recommended for this condition, they do not make a recommendation for a ranking of the different topical treatments.
Croatian: Povjerenstvo je prihvatilo argument nositelja odobrenja da iako aktualne kliničke smjernice razlikuju terapije estrogenom u slučaju sistemske i topikalne primjene, gdje je jasno da se topikalne terapije preporučuju za ovo stanje, u smjernicama se ne navodi rang preporuka između različitih topikalnih terapija.
English: The CHMP took also into account the available data for Linoladiol HN, which was limited mainly to postmarketing data.
Croatian: CHMP je također uzeo u obzir podatke dostupne za Linoladiol HN, koji su bili ograničeni uglavnom na podatke nakon stavljanja lijeka u promet.
English: In May 2012, Germany (BfArM) requested the evaluation of the overall benefit risk balance of high concentration estradiol (E2) containing medicinal products indicated for topical use for the treatment of vaginal atrophy (intravaginally and on the skin of vulva and vagina).
Croatian: U svibnju 2012., Njemačka (BfArM) je zatražila evaluaciju cjelokupnog omjera koristi i rizika lijekova koji sadrže visoke koncentracije estradiola (E2) za topikalnu primjenu za liječenje vaginalne atrofije (intravaginalno te na koži vulve i vagine).