FrancophonIA/ELRC3.0 huggingface dataset:
English: As compared with the non-pregnant state, the 6-week post-partum period is associated with a 3 to 9-fold risk of stroke, 3 to 6-fold risk of myocardial infraction, 9 to 22-fold risk of venous thromboembolic event and depression is estimated to occur in approximately 1 in 10 women while psychosis is estimated to occur in approximately 1-2 in 1000 women.
Croatian: U usporedbi sa stanjem netrudnoće, postpartalno razdoblje od 6 tjedana povezano je s 3 do 9 puta većim rizikom od moždanog udara, 3 do 6 puta većim rizikom od infarkta miokarda i 9 do 22 puta većim rizikom od venskog tromboembolijskog poremećaja, a procjenjuje se da se depresija događa u približno 1 na 10 žena dok se procjenjuje da se psihoza događa u približno 1-2 na 1000 žena.
English: If any symptoms of hypertension or evidence of central nervous system toxicity are detected, the administration of bromocriptine should be discontinued;
Croatian: Ako se uoče simptomi hipertenzije ili dokazi toksičnih pojava u središnjem živčanom sustavu, potrebno je prekinuti primjenu bromokriptina;
English: The second survey conducted in France retrieved a higher number of AEs, however this might not reflect an absolute increase in occurrence of those events but be the consequence of a change in post-marketing reporting of these events as more breastfeeding mothers were closely followed.
Croatian: Druga inspekcija provedena u Francuskoj otkrila je veći broj nuspojava, međutim to možda ne odražava apsolutni porast u pojavi tih poremećaja, ali može biti posljedica promjene u izvješćivanju o tim poremećajima nakon stavljanja lijeka u promet jer je pomno praćeno više dojilja.
English: Moreover, it was noted that at present the indication lactation inhibition in post-partum was also approved in high strengths, which should not be used for this indication.
Croatian: Štoviše, zabilježeno je da je trenutna indikacija postpartalne inhibicije laktacije odobrena i u većim jačinama koje se ne bi smjele koristiti za ovu indikaciju.
English: Following assessment of all the data, the PRAC concluded the contraindications already in place in most Member States (MSs) were valid and should be included in the PIs across all MSs.
Croatian: Nakon procjene svih podataka, PRAC je zaključio da su kontraindikacije već uključene kod većine država članica bile valjane i da ih treba uključiti u informacije o lijeku u svim državama članicama.
English: A second French national pharmacovigilance survey, finalised in 2012, showed an increase in the reporting rate of serious cardiovascular ADRs compared with the previous one (5.1 vs. 3.36 cases / 100,000 patients treated), despite the reinforcement of the SmPC in 1994.
Croatian: Drugo francusko nacionalno farmakovigilancijsko istraživanje dovršenu u 2012. pokazalo je porast stope prijavljivanja ozbiljnih kardiovaskularnih nuspojava u usporedbi s prethodnim razdobljem (5,1 naspram 3,36 slučaj/100 000 liječenih bolesnika) unatoč dodatnim napomenama u sažetku opisa svojstava lijeka 1994. godine.
English: Herings and colleagues concluded that, cardiovascular or cerebrovascular events observed could probably be explained by pre-existing morbidity rather than by the use of bromocriptine.
Croatian: Herings i kolege zaključili su da se uočena kardiovaskularna ili cerebrovaskularna stanja mogu objasniti već postojećom morbidnošću radije nego uporabom bromokriptina.
English: Considering the mechanism of regulation of lactation and the results of these studies the PRAC considered the efficacy of bromocriptine in lactation inhibition sufficiently demonstrated.
Croatian: Razmatrajući mehanizam regulacije laktacije i rezultate tih ispitivanja, PRAC je smatrao da je djelotvornost bromokriptina u inhibiciji laktacije dostatno dokazana.
English: The study observing the risks of hypertension found that while bromocriptine did not appear to increase the risk of inducing post-partum hypertension, it may aggravate already existing pregnancy-induced hypertension.
Croatian: Ispitivanje u kojem su se proučavali rizici od hipertenzije otkrilo je da dok se ne čini da bromokriptin povećava rizik od indukcije postpartalne hipertenzije, može pogoršati već postojeću hipertenziju uzrokovanu trudnoćom.
English: Based on a case report, it was recommended that familial history of preeclampsia should be included as a contraindication of bromocriptine in post-partum and for blood pressure to be closely monitored, especially in case of headaches (Makdassi, 1991).
Croatian: Na temelju izvješća slučaja preporučuje sa da se obiteljska anamneza predeklampsije uključi kao kontraindikacija za bromokriptin u postpartalnom razdoblju kao i pomni nadzor tlaka krvi u slučaju glavobolja (Makdassi,1991.).
English: Although most of the studies conducted with bromocriptine are conducted before 1990, the available evidence from clinical trials conducted as part of the original clinical development plan as well as from the published literature suggests that bromocriptine is efficacious in the indication currently under review and appeared superior to androgens, combined contraceptives, anti-oestrogens, pyridoxine, and of similar efficacy than that of other dopamine agonists, though possibly better than lisuride.
Croatian: Iako je većina ispitivanja provedenih s bromokriptinom dovršena prije 1990.godine, dostupni dokazi iz kliničkih ispitivanja provedeni kao dio originalnog plana kliničkog razvoja kao i iz objavljenje literature ukazuju na to da je bromokriptin djelotvoran u indikaciji koja se trenutno razmatra te se čini da je superioran androgenima, kombiniranim kontraceptivima, antiestrogenima, piridoksinu kao i da je slične djelotvornosti od drugih agonista dopamina iako je moguće i bolji od lizurida.
English: With regards to off label use and misuse, while high rates were reported in the French surveys, the analysis of the safety database of the MAH of the originator covering the period since the first marketing authorisation, focused on the dose and treatment duration, retrieved much lower rates (4.2% and 4.7% respectively).
Croatian: S obzirom na uporabu izvan odobrenih indikacija i zlouporabu dok su istovremeno prijavljene visoke stope u francuskim ispitivanjima, analiza baze podataka nositelja odobrenja za lijek prvog proizvođača koja je pokrivala razdoblje od prvog odobrenja usmjerila se na dozu i na trajanje liječenja te je te je otkrila puno niže stope (4,2% odnosno 4,7%).
English: In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Croatian: U nekih bolesnika razvoju napada ili moždanog udara prethodila je jaka glavobolja i/ili prolazni poremećaji vida.
English: In the mid-1990s the indication of lactation was withdrawn in the United States and some other countries in view of reports of cardiovascular adverse events (AEs) in women treated with bromocriptine-containing products for lactation inhibition.
Croatian: Sredinom 90-ih godina indikacija laktacije povučena je u Sjedinjenim Državama i nekim drugim državama zbog izvješća o kardiovaskularnim nuspojavama u žena liječenih proizvodima koji sadrže bromokriptin za inhibiciju laktacije.
English: Clinical studies and published literature supported the use of bromocriptine in prevention or suppression of physiological lactation in post-partum.
Croatian: Klinička ispitivanja i objavljena literatura podržali su uporabu bromokriptina u prevenciji i supresiji fiziološke laktacije u postpartalnom razdoblju.
English: In addition, as one dose administered should not exceed 2.5 mg in this indication, in order to minimise the risk of misuse and medication error, the indication prevention or suppression of lactation should be removed from the product information of the higher strengths.
Croatian: Pored toga, jedna primijenjena doza ne smije premašiti 2,5 mg u ovoj indikaciji kako bi se smanjio rizik od zlouporabe i pogrešnog doziranja, indikaciju prevencije ili supresije laktacije treba ukloniti iz informacija o proizvodu za više jačine.
English: However, although some efficacy was suggested in the treatment of mastitis and painful breast engorgement, these studies were limited and did not constitute sufficient evidence to support including these situations as examples in the indication.
Croatian: Međutim, iako je predložena određena djelotvornost u liječenju mastitisa i bolnih dojki s uvećanjem, ta su ispitivanja bila ograničena i nisu predstavljala dovoljan dokaz da bi se ta stanja kao primjere navelo u indikaciji.
English: Overall summary of the scientific evaluation of bromocriptine containing medicinal products (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijekova koji sadrže bromokriptin (vidjeti prilog I.)
English: However in some reports, factors suggesting a possible causal association are present (no other risk factor or confounders, short time to onset (between 6 hours and 17 days after treatment initiation for the fatal cases where the information was available), positive de-challenge and re-challenge).
Croatian: Međutim, u nekim slučajevima bili su prisutni čimbenici koji su ukazivali na moguću uzročnu povezanost (nema drugih čimbenika koji bi zbunjivali, vrijeme do nastupa bilo je kratko (između 6 sati i 17 dana nakon početka liječenja za smrtne slučajeve kad je informacija bila dostupna), pozitivno ponovo uvođenje lijeka u terapiju i isključivanje lijeka iz terapije).
English: Furthermore, in part of the cases important risk factors (smoking, obesity, pre-eclampsia, hypertension, history of psychiatric episodes) were reported.
Croatian: Nadalje, u dijelu slučajeva prijavljeni su važni čimbenici rizika (pušenje, gojaznost, predeklampsija, hipertenzija, anamneza psihijatrijskih epizoda).
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for bromocriptine-containing medicinal products for oral use in the postpartum inhibition of lactation;
Croatian: • PRAC je razmotrio postupak iz članka 31. Direktive 2001/83/EZ koji proizlazi iz podataka o farmakovigilanciji za lijekove koji sadrže bromokriptin za peroralnu primjenu u postpartalnoj inhibiciji laktacije;
English: Therefore, in accordance with Articles 32 of Directive 2001/83/EC, the PRAC recommends the variation to the terms of the marketing authorisations, for all medicinal products containing bromocriptine identified in Annex I and for which the amendments to the product information are set out in Annex III of the PRAC recommendation.
Croatian: Stoga, u skladu s člankom 32. Direktive 2001/83/EZ, PRAC preporučuje izmjenu uvjeta odobrenja za stavljanje lijeka u promet za sve lijekove koji sadrže bromokriptin navedene u prilogu I. i za koje su izmjene informacija o lijeku navedene u prilogu III. preporuke PRAC-a.
English: However, although the studies conducted in mastitis, breast engorgement and painful breast engorgement suggested some efficacy, the limited data available does not allow concluding on the efficacy of bromocriptine in these indications.
Croatian: Međutim, iako ispitivanja provedena kod mastitisa, nabreklih dojki i bolnih dojki s uvećanjem ukazuju na određenu djelotvornost, dostupni ograničeni podatci ne dopuštaju zaključivanje o djelotvornosti bromokriptina u tim indikacijama.
English: Bromocriptine is used to prevent or suppress lactation in women who have given birth.
Croatian: Bromokriptin se koristi za sprječavanje ili supresiju laktacije u žena nakon poroda.
English: In some studies bromocriptine was associated with higher incidence of rebound phenomenon compared to cabergoline (in one study), and similar to lisuride or non-ergot dopamine agonist.
Croatian: U nekim je ispitivanjima bromokriptin povezan s višom incidencijom povratnog učinka u usporedbi s kabergolinom (u jednom ispitivanju) te slično lizuridu ili neergotskom agonistu dopamina.
English: The PRAC was of the opinion that this potential risk could be mitigated through limiting the use of bromocriptine to circumstances where breastfeeding is not possible due to medical reasons (such as intrapartum loss, neonatal death, HIV infection of the mother) and inclusion of contraindications, warning and precautions in the product information, as it is already the case in some Member States.
Croatian: PRAC je smatrao da se taj potencijalni rizik može umanjiti ograničavanjem uporabe bromokriptina na situacije kod kojih dojenje nije moguće zbog medicinskih razloga (poput gubitka ploda tijekom trudnoće, smrti novorođenčeta, infekcije HIV-om u majke) te uključivanjem kontraindikacija, upozorenja i mjera opreza u informacije o lijeku, jer to je već bio slučaj u nekim državama članicama.
English: In light of the above, and given the widespread use of bromocriptine in lactation inhibition, the ANSM considered that the benefit/risk ratio of bromocriptine-containing products in this indication is unfavourable and that it is in the interest of the Union to refer the bromocriptine-containing medicinal products for oral use indicated in post-partum inhibition of lactation to the PRAC and requested in July 2013 that it gives a recommendation under Article 31 of Directive 2001/83/EC, on whether marketing authorisations of these products should be maintained, varied, suspended or withdrawn.
Croatian: U svjetlu navedenog i uzimajući u obzir raširenu uporabu bromokriptina u inhibiciji laktacije, ANSM je smatrao da je omjer koristi i rizika lijekova koji sadrže bromokriptin u ovoj indikaciji nepovoljan i da je u interesu Europske unije da uputi predmet lijekova koji sadrže bromokriptin za peroralnu primjenu, indiciranih za inhibiciju postpartalne laktacije PRAC-u te je u srpnju 2013. od PRAC-a tražio izdavanje preporuke u skladu s člankom 31. Direktive 2001/83/EZ o tome treba li održati, mijenjati ili suspendirati, odnosno povući rješenje o odobrenju za stavljanje tih lijekova u promet.
English: Although some factors suggested causality of the events to bromocriptine, independent risk factors for these types of events are present in the post-partum period.
Croatian: Iako su neki čimbenici ukazali na uzročnu povezanost poremećaja s bromokriptinom, nezavisni čimbenici rizika za te tipove poremećaja prisutni su u razdoblju nakon poroda.
English: • The PRAC recommended to limit the use of bromocriptine-containing medicinal products for oral use in the post-partum inhibition of lactation with strength of 1 mg and 2.5 mg to cases where medically indicated.
Croatian: • PRAC je preporučio ograničavanje uporabe lijekova koji sadrže bromokriptin u postpartalnoj inhibiciji laktacije s jačinama od 1 i 2,5 mg na medicinski opravdane slučajeve.
English: In addition the use of these products is not recommended for routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention or with analgesics.
Croatian: Osim toga uporaba ovih proizvoda ne preporučuje se za rutinsku supresiju laktacije niti za olakšavanje simptoma postpartalne boli i uvećanja dojki koji se mogu odgovarajuće liječiti nefarmakološkom intervencijom ili analgeticima.
English: Following the assessment of the relevant data, the PRAC recommended not to use bromocriptine for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Croatian: Nakon procjene relevantnih podataka, PRAC je preporučio da se bromokriptin ne koristi za rutinsku supresiju laktacije niti za olakšavanje simptoma postpartalne boli i uvećanja koji se mogu na odgovarajući način liječiti nefarmakološkom intervencijom (primjerice čvrstom potporom za dojke, primjenom leda) i/ili jednostavnim analgeticima.
English: The PRAC recommended that blood pressure should be closely monitored, especially during the first days of therapy and a warning advising to discontinue treatment in case of hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity, and that this should be reflected in the product information.
Croatian: PRAC je preporučio pomni nadzor krvnog tlaka posebice tijekom prvih dana terapije i upozorenja o prekidu liječenja u slučaju hipertenzije, poremećaja koji ukazuju na bol u prsima, teške, progresivne ili nepopustljive glavobolje (sa smetnjama vida ili bez njih), odnosno kod dokazane toksičnosti središnjeg živčanog sustava i da to treba opisati u informacijama o lijeku.
English: The review of the fatal cases showed that risk factors were present in many of the cases where the information was available such as severe hypertension, hypertensive disorders of pregnancy, history of coronary artery disease or other cardiovascular condition as well history of psychiatric episodes.
Croatian: Pregled smrtnih slučajeva pokazao je da su čimbenici rizika prisutni u mnogim slučajevima u kojima su postojale dostupne informacije poput teške hipertenzije, hipertenzivnog poremećaja uzrokovanog trudnoćom, anamneze bolesti koronarnih arterija, o drugim kardiovaskularnim stanjima kao psihijatrijski poremećaji.
English: The PRAC reviewed the safety results from all clinical studies conducted as part of the initial development plan and noted that no cardiovascular, neurological or psychiatric adverse events in association with post-partum administration of bromocriptine were observed.
Croatian: PRAC je pregledao rezultate ispitivanja sigurnosti iz svih kliničkih studija kao dio prvotnoga plana razvoja i zabilježio da nisu uočene kardiovaskularne, neurološke ili psihijatrijske nuspojave povezane s postpartalnom primjenom bromokriptina.
English: The CMDh, having considered the PRAC recommendation dated 10 July 2014 with regards to the bromocriptine containing medicinal products, agrees with the recommendation therein as stated below:
Croatian: Nakon što je razmotrio konačnu preporuku PRAC-a od 10. srpnja 2014. godine o lijekovima koji sadrže bromokriptin, CMDh je suglasan s preporukom iznesenom u nastavku:
English: • Finally, for the bromocriptine-containing medicinal products for oral use in the post-partum inhibition of lactation with the strengths of 5 mg and 10 mg, the PRAC is of the opinion that the benefit does not outweigh the risks of misuse and medication error and therefore recommended this indication to be deleted.
Croatian: • U konačnici, PRAC smatra da za sve lijekove koji sadrže bromokriptin za peroralnu primjenu u postpartalnoj inhibiciji laktacije jačine 5 i 10 mg korist ne nadmašuje rizike od zlouporabe i pogrešnog doziranja i stoga preporučuje brisanje te indikacije.
English: A range of adverse events have been reported, including depression, psychosis, myocardial infarction, stroke, intracranial haemorrhage, thrombotic events, convulsions, and hypertension.
Croatian: Prijavljen je niz nuspojava uključujući depresiju, psihozu, infarkt miokarda, moždani udar, intrakranijalno krvarenje, trombotičke poremećaje, konvulzije i hipertenziju.
English: • The PRAC reviewed all available data from post-marketing spontaneous case reports, clinical trials, published literature and other available information on bromocriptine-containing medicines for oral use with regards to the cardiovascular, neurological and psychiatric risk following treatment in post-partum lactation inhibition.
Croatian: • PRAC je pregledao sve dostupne podatke iz spontanih izvješća nakon stavljanja lijeka u promet, kliničkih ispitivanja, objavljene literature i drugih dostupnih informacija o lijekovima koji sadrže bromokriptin za peroralnu primjenu s obzirom na kardiovaskularni, neurološki i psihijatrijski rizik nakon liječenja postpartalne laktacije inhibicijom.
English: Concomitantly, in France, following a first national pharmacovigilance survey that showed that cardiovascular adverse drug reactions (ADRs) accounted for an important proportion of the AEs reported, the summary of product characteristics (SmPC) had been reinforced with respect to these ADRs.
Croatian: Istodobno je u Francuskoj, nakon prve nacionalne farmakovigilancijske inspekcije koja je pokazala da kardiovaskularne nuspojave čine važan udio u broju prijavljenih nuspojava, uvedena izmjena sažetka u pogledu tih nuspojava.
English: Based on these conclusions, the PRAC concluded that the benefit-risk balance of bromocriptinecontaining medicinal products remains favourable subject to changes to the product information, including agreed restrictions and warnings.
Croatian: Na temelju tih zaključaka PRAC je donio zaključak da omjer koristi i rizika lijekova koji sadrže bromokriptin ostaje povoljan i podložan promjenama u informacijama o proizvodu, uključujući i dogovorena ograničenja i upozorenja.
English: In conclusion, based on the available information a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events cannot be excluded.
Croatian: Zaključno, na temelju dostupnih informacija nije moguće isključiti uzročnu povezanost između uporabe bromokriptina i ozbiljnih kardiovaskularnih, neuroloških ili psihijatrijskih poremećaja.
English: It should be kept in mind that the post-partum is a vulnerable period with background risks of hypertension, convulsions, pre-eclampsia, psychiatric events and cardiovascular/cerebrovascular and thrombotic events.
Croatian: Treba imati na umu da je postpartalno razdoblje osjetljivo razdoblje s temeljnim rizicima od hipertenzije, konvulzija, predeklampsije, psihijatrijskih poremećaja i kardiovaskularnih/cerebrovaskularnih trombotskih poremećaja.
English: The CMDh having considered the PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation to the terms of the marketing authorisations of bromocriptine-containing medicinal products for oral use indicated in postpartum inhibition of lactation for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Croatian: Razmotrivši preporuke PRAC-a od 10. srpnja 2014. godine u skladu s člankom 107.k stavcima 1. i 2. Direktive 2001/83/EZ, CMDh je zauzeo stajalište da je potrebna izmjena uvjeta za stavljanje u promet lijekova koji sadrže bromokriptin za peroralnu primjenu u postpartalnoj inhibiciji laktacije za koje su relevantni dijelovi sažetka opisa svojstava lijeka i upute o lijeku opisani u prilogu III.
English: Based on the available data the PRAC could not exclude a causality between the use of bromocriptine and cardiovascular, neurovascular and psychiatric events; these are already included in many PI for these products.
Croatian: Na temelju dostupnih podataka PRAC nije mogao isključiti uzročnu povezanost između uporabe bromokriptina i kardiovaskularnih, neurovaskularnih i psihijatrijskih poremećaja koji su već uključeni u značajan dio informacija za te lijekove.
English: The PRAC considered the relation between the use of bromocriptine-containing medicinal products for oral use in post-partum inhibition of lactation and the occurrence of serious cardiovascular, neurological and psychiatric adverse events.
Croatian: PRAC je razmatrao povezanost između uporabe lijekova koji sadrže bromokriptin za peroralnu primjenu u postpartalnoj inhibiciji laktacije i pojavu ozbiljnih kardiovaskularnih, neuroloških i psihijatrijskih nuspojava.