natgillin/translations-raw huggingface dataset:
From the pathogenic point of view, it is likely that vasospasm is responsible for these events.
Z vidika patogenosti je verjetno, da je bil vzrok za te dogodke vazospazem.
If any symptoms of hypertension or evidence of central nervous system toxicity are detected, the administration of bromocriptine should be discontinued;
Če se odkrijejo kakršni koli simptomi hipertenzije ali znaki toksičnih učinkov na osrednji živčni sistem, je treba uporabo bromokriptina prekiniti;
The absolute number of cases reported in post-marketing is low, especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to 0.005% to 0.04%.
Absolutno število primerov, o katerih so poročali v obdobju trženja, je majhno, zlasti glede na dejstvo, da je bromokriptin v EU na voljo od leta 1973 in da mu je bilo izpostavljeno precejšnje število bolnic - ocenjuje se, da je skupna incidenca od 0,005 % do 0,04 %.
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.
V drugi raziskavi, ki so jo izvedli v Franciji, so zabeležili večje število neželenih dogodkov, vendar ni nujno, da to odraža absolutno povečanje pojava omenjenih dogodkov, temveč je lahko posledica sprememb v poročanju o teh dogodkih v obdobju trženja, ko so skrbno spremljali več doječih mater.
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
In the clinical trial assessing the efficacy of bromocriptine in late post-partum, treatment was initiated at times covering adequately the late post-partum period (10 to 13.8 days post-partum and 38.9 days to 16.7 weeks post-partum).
V kliničnem preskušanju, v katerem so ocenjevali učinkovitost bromokriptina v poznem poporodnem obdobju, so zdravljenje uvedli ob časovnih točkah, ki so ustrezno pokrile pozno poporodno obdobje (od 10 do 13,8 dneva po porodu in od 38,9 dneva do 16,7 tedna po porodu).
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.
V primerjavi z obdobjem brez nosečnosti je 6-tedensko obdobje po porodu povezano s 3- do 9-krat večjim tveganjem za možgansko kap, 3- do 6-krat večjim tveganjem za srčni infarkt in 9- do 22-krat večjim tveganjem za venske trombembolične dogodke, prav tako pa se po ocenah pri približno 1 ženski od 10 pojavi depresija in pri približno 1-2 ženskah od 1000 psihoza.
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).
Kar zadeva nenamensko in napačno uporabo, so v francoski raziskavi poročali o visokih stopnjah tovrstne uporabe, vendar je analiza zbirke podatkov o varnosti imetnika dovoljenja za promet z originatorskim zdravilom, zbranih v obdobju od izdaje prvega dovoljenja za promet, ki je bila osredotočena na odmerek in trajanje zdravljenja, pokazala veliko nižje stopnje (4,2 % oziroma 4,7 %).
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).
Na podlagi poročila o primeru je bilo priporočeno, da se kot kontraindikacija za uporabo bromokriptina po porodu vključi preeklampsija v družinski anamnezi in da se skrbno spremlja krvni tlak, zlasti v primeru glavobolov (Makdassi, 1991).
The PRAC concluded that these should not be mentioned in the product information as examples of situations where bromocriptine could be used.
Odbor PRAC je zaključil, da te indikacije ne smejo biti navedene v informacijah o zdravilu med primeri okoliščin, v katerih se bromokriptin lahko uporablja.
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.
Druga francoska nacionalna raziskava farmakovigilance, ki se je zaključila leta 2012, je pokazala višjo stopnjo poročanja o resnih srčno-žilnih neželenih učinkih zdravila v primerjavi s prejšnjim pregledom (5,1 v primerjavi s 3,36 primera/100 000 zdravljenih bolnic), kljub dopolnitvi povzetka glavnih značilnosti zdravila leta 1994.
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.
Ugotovljeno je bilo tudi, da so trenutno za indikacijo zaviranja laktacije po porodu odobrene tudi večje jakosti, ki se za to indikacijo ne bi smele uporabljati.
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.
Čeprav so večino študij z bromokriptinom izvedli pred letom 1990, razpoložljivi dokazi iz kliničnih preskušanj, izvedenih v okviru prvotnega načrta kliničnega razvoja, in objavljene literature kažejo, da je bromokriptin učinkovit pri indikaciji, ki je predmet trenutnega pregleda, in naj bi bil učinkovitejši od androgenov, kombiniranih kontraceptivov, antiestrogenov in piridoksina ter podobno učinkovit kot drugi agonisti dopamina oziroma verjetno učinkovitejši od lizurida.
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.
Herings in sodelavci so zaključili, da bi opažene srčno-žilne in cerebrovaskularne dogodke verjetno lahko bolj pojasnili s predhodno prisotnim obolenjem kot z uporabo bromokriptina.
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.
Potem ko je odbor PRAC ocenil vse podatke, je zaključil, da so kontraindikacije, ki se že uporabljajo v večini držav članic, utemeljene in jih je treba vključiti v informacije o zdravilu v vseh državah članicah.
Bromocriptine is used to prevent or suppress lactation in women who have given birth.
Bromokriptin se uporablja za preprečevanje ali zaviranje laktacije pri ženskah po porodu.
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.
Čeprav nekateri dejavniki kažejo na vzročno povezavo med dogodki in bromokriptinom, so v poporodnem obdobju prisotni neodvisni dejavniki tveganja za tovrstne dogodke.
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.
Ob upoštevanju zgoraj navedenega in glede na razširjenost uporabe bromokriptina za zaviranje laktacije je agencija ANSM menila, da razmerje med tveganji in koristmi zdravil, ki vsebujejo bromokriptin, pri tej indikaciji ni ugodno in da je v interesu Unije, da napoti zdravila za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, na odbor PRAC, zato ga je julija 2013 zaprosila, da poda priporočilo v skladu s členom 31 Direktive 2001/83/ES o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
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).
Vendar so v nekaterih poročilih prisotni dejavniki, ki nakazujejo možno vzročno povezavo (nobenih drugih dejavnikov tveganja ali sočasnih dejavnikov, kratek čas do nastopa neželenih učinkov (od 6 ur do 17 dni po začetku zdravljenja v primerih s smrtnim izidom, za katere so bili na voljo podatki),
Clinical studies and published literature supported the use of bromocriptine in prevention or suppression of physiological lactation in post-partum.
Klinične študije in objavljena literatura podpirajo uporabo bromokriptina za preprečevanje ali zaviranje fiziološke laktacije po porodu.
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.
V študiji, v kateri so opazovali tveganja za hipertenzijo, so ugotovili, da bromokriptin verjetno ne poveča tveganja za razvoj hipertenzije po porodu, vendar pa lahko poslabša že obstoječo hipertenzijo zaradi nosečnosti.
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.
Ob upoštevanju mehanizma uravnavanja laktacije in rezultatov teh študij je odbor PRAC menil, da je bila učinkovitost bromokriptina pri zaviranju laktacije zadovoljivo dokazana.
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:
Skupina CMDh se je po proučitvi priporočila, ki ga je za zdravila, ki vsebujejo bromokriptin, 10. julija 2014 izdal odbor PRAC, strinjala s priporočilom, ki je navedeno v nadaljevanju:
No causal association was shown in the three observational studies investigating the risk of seizures, (Rothman, 1990) cardio- and cerebrovascular events, (Herings, 1995) and hypertension (Watson, 1989).
V treh opazovalnih študijah, v katerih so raziskovali tveganje za epileptične napade (Rothman, 1990), srčno-žilne in cerebrovaskularne dogodke (Herings, 1995) ter hipertenzijo (Watson, 1989), niso opazili nobene vzročne povezave.
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.
Po drugi strani pa kljub temu, da so študije, izvedene v zvezi z mastitisom, nabreklostjo dojk in bolečo nabreklostjo dojk, pokazale določeno učinkovitost, omejeni razpoložljivi podatki ne omogočajo zaključka o učinkovitosti bromokriptina pri teh indikacijah.
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.
Odbor PRAC je menil, da bi lahko omenjeno možno tveganje zmanjšali z omejitvijo uporabe bromokriptina na okoliščine, v katerih dojenje ni mogoče zaradi zdravstvenih razlogov (na primer izguba otroka med porodom, smrt novorojenčka, okužba matere z virusom HIV), in z vključitvijo kontraindikacij, opozoril in previdnostnih ukrepov v informacije o zdravilu, kar je že mogoče zaslediti v nekaterih državah članicah.
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.
Sredi devetdesetih let prejšnjega stoletja so Združene države Amerike in še nekatere druge države umaknile indikacijo, povezano z laktacijo, zaradi poročil o srčno-žilnih neželenih dogodkih pri ženskah, ki so se zdravile z zdravili, ki vsebujejo bromokriptin, za zaviranje laktacije.
• 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.
• v zvezi z zdravili za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, jakosti 5 mg in 10 mg, je odbor PRAC menil, da njihove koristi ne odtehtajo tveganj za napačno uporabo in napake pri zdravljenju, zato je priporočil, da se ta indikacija izbriše.
Therefore the PRAC recommended that safety information be included in the SmPC across the Member States.
Odbor PRAC je zato priporočil, da se v vseh državah članicah v povzetek glavnih značilnosti zdravila vključijo informacije o varnosti.
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.
V skladu s členom 32 Direktive 2001/83/ES zato odbor PRAC priporoča spremembo pogojev dovoljenj za promet z zdravilom za vsa zdravila, ki vsebujejo bromokriptin in so navedena v Prilogi I ter za katera so spremembe informacij o zdravilu opredeljene v Prilogi III k temu priporočilu odbora PRAC.
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.
Poleg tega uporaba teh zdravil ni priporočljiva za rutinsko zaviranje laktacije ali lajšanje simptomov poporodne bolečine in nabreklosti, ki jih je mogoče ustrezno zdraviti z nefarmakološkimi ukrepi ali analgetiki.
• 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.
• odbor PRAC je priporočil omejitev uporabe zdravil za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, jakosti 1 mg in 2,5 mg, na primere, ko so prisotne zdravstvene indikacije.
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.
Upoštevati je treba, da je poporodno obdobje občutljivo obdobje, v katerem so prisotna tveganja za hipertenzijo, konvulzije, preeklampsijo, psihiatrične dogodke ter srčno-žilne/cerebrovaskularne in trombotične dogodke.
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.
V nekaterih študijah je bil bromokriptin povezan z večjo incidenco povratnega fenomena kot kabergolin (v eni študiji) in s podobno kot lizurid ali agonist dopamina, ki ni derivat ergot alkaloidov.
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.
Odbor PRAC je priporočil skrbno spremljanje krvnega tlaka, zlasti v prvih dneh zdravljenja, in opozorilo, da je treba zdravljenje prekiniti, če se pojavi hipertenzija, pomenljiva bolečina v prsnem košu, hud, progresiven ali neprekinjen glavobol (z motnjami vida ali brez njih) ali znaki toksičnih učinkov na osrednji živčni sistem, vse to pa je treba vključiti v informacije o zdravilu.
Overall, considering the substantial exposure to this active substance, the PRAC considered the number of cases as low.
Na splošno je odbor PRAC menil, da je glede na precejšnjo izpostavljenost tej zdravilni učinkovini število primerov majhno.
• 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.
• odbor PRAC je pregledal vse razpoložljive podatke iz spontanih poročil o primerih iz obdobja trženja, kliničnih preskušanj in objavljene literature ter druge razpoložljive informacije o zdravilih za peroralno uporabo, ki vsebujejo bromokriptin, v zvezi s srčno-žilnim, nevrološkim in psihiatričnim tveganjem, povezanim z zdravljenjem za zaviranje laktacije po porodu.
Furthermore, in part of the cases important risk factors (smoking, obesity, pre-eclampsia, hypertension, history of psychiatric episodes) were reported.
Poleg tega so v nekaterih primerih poročali o pomembnih dejavnikih tveganja (kot so kajenje, debelost, preeklampsija, hipertenzija in epizode psihiatričnih motenj v anamnezi).
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.
Po drugi strani pa so bile študije, ki so sicer pokazale določeno učinkovitost pri zdravljenju mastitisa in boleče nabreklosti dojk, omejene in niso zagotovile zadostnih dokazov, da bi te okoliščine vključili v indikacijo kot primere.
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.
Pregled primerov s smrtnim izidom je pokazal, da so bili v številnih primerih, za katere so bili na voljo podatki, prisotni dejavniki tveganja, kot na primer huda hipertenzija, hipertenzivne motnje v nosečnosti, bolezen koronarnih arterij ali druga srčno-žilna bolezen v anamnezi ter epizode psihiatričnih motenj v anamnezi.
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.
Odbor PRAC je pregledal rezultate o varnosti iz vseh kliničnih študij, ki so bile izvedene v okviru prvotnega načrta razvoja, in ugotovil, da niso bili opaženi nobeni srčno-žilni, nevrološki ali psihiatrični neželeni dogodki, povezani z uporabo bromokriptina po porodu.
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.
Potem ko je odbor PRAC ocenil zadevne podatke, je priporočil, naj se bromokriptin ne uporablja za rutinsko zaviranje laktacije ali lajšanje simptomov poporodne bolečine in nabreklosti, ki jih je mogoče ustrezno zdraviti z nefarmakološkimi ukrepi (na primer s podpiranjem dojk ali ledenimi obkladki) in/ali s preprostimi analgetiki.
A range of adverse events have been reported, including depression, psychosis, myocardial infarction, stroke, intracranial haemorrhage, thrombotic events, convulsions, and hypertension.
Poročali so o vrsti različnih neželenih dogodkov, med katerimi so bili depresija, psihoza, miokardni infarkt, možganska kap, intrakranialna krvavitev, trombotični dogodki, konvulzije in hipertenzija.
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.
Na podlagi razpoložljivih podatkov odbor PRAC ni mogel izključiti vzročne povezave med uporabo bromokriptina in srčno-žilnimi, nevrovaskularnimi in psihiatričnimi dogodki - ti so že vključeni v številne informacije o zdravilu za ta zdravila.
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.
Na podlagi teh zaključkov je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo bromokriptin, še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu, vključno z dogovorjenimi omejitvami in opozorili.
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.
Skupina CMDh je na podlagi proučitve priporočila odbora PRAC z dne 10. julija 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe pogojev dovoljenj za promet z zdravili za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III.
• 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;
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu;
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.
Poleg tega je treba zaradi dejstva, da en dani odmerek pri indikaciji preprečevanja ali zaviranja laktacije ne sme preseči 2,5 mg, za zmanjšanje tveganja za napačno uporabo ali napake pri zdravljenju to indikacijo izbrisati iz informacij o zdravilu za večje jakosti.