FrancophonIA/ELRC3.0 huggingface dataset:
English: The provided clinical data demonstrated that Girolan was effective in the treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli when administered at 20,000 IU apramycin per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Slovenian: Predloženi klinični podatki so pokazali, da je zdravilo Girolan učinkovito pri zdravljenju bakterijskega enteritisa, ki ga povzroča E. coli, kadar se daje v odmerku 20 000 i.e. apramicina na kilogram telesne mase (kar ustreza 36 mg zdravila/kg telesne mase) vsak dan pet dni zapored.
English: In support of the indication for treatment and metaphylaxis of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Slovenian: V podporo indikaciji za zdravljenje in metafilakso bakterijskega enteritisa, ki ga povzroča bakterija E. coli, je imetnik dovoljenja za promet z zdravilom predložil podatke o občutljivosti in vitro ter klinične podatke, vključno s terenskimi študijami.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Slovenian: PODATKI NA STIČNI OVOJNINI - KOMBINIRANO OZNAČEVANJE IN NAVODILO ZA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: In support of the indication for treatment of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Slovenian: V podporo indikaciji za zdravljenje bakterijskega enteritisa, ki ga povzroča E. coli, je imetnik dovoljenja za promet z zdravilom predložil podatke o občutljivosti in vitro ter klinične podatke, vključno s terenskimi študijami.
English: Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry - link disease caused by Salmonella Pullorum is considered an exceptional circumstance that would require to treat (or slaughter) clinically affected flocks.
Slovenian: Vendar pa bolezen, ki jo povzročaSalmonella Pullorum, velja za izjemne okoliščine, zaradi katerih je potrebno zdravljenje (ali zakol) klinično prizadetih jat.
English: Calves:
Slovenian: Teleta:
English: Lay:
Slovenian: Kunci:
English: X mean body weight (kg) of animals to be treated =
Slovenian: X povprečna telesna masa (kg)
English: Calves, pigs, rabbits
Slovenian: Teleta, prašiči, kunci
English: Aminoglycosides may have a negative influence on the kidney function.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Aminoglikozidi lahko imajo negativen vpliv na delovanje ledvic.
English: 6.3 Shelf life
Slovenian: <DD/MM/LLLL>
English: Each sachet contains 1 x 106 IU apramycin sulfate and weight of 1.8 g of product.
Slovenian: Ena plastenka vsebuje 50 x 106 i.e. apramicinijevega sulfata oziroma 91 g zdravila.
English: Powder for oral administration
Slovenian: Prašek za peroralno dajanje
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 1 x 106 i.e.
English: In support of the indication for treatment of colibacillosis the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Slovenian: V podporo indikaciji za zdravljenje kolibaciloze, ki jo povzroča E. coli, je imetnik dovoljenja za promet z zdravilom predložil podatke o občutljivosti in vitro ter klinične podatke, vključno s terenskimi študijami.
English: This information can be coordinated at individual Member States level.
Slovenian: Informacije se lahko usklajujejo na ravni posamezne države članice.
English: Furthermore the blood pressure of patients should be carefully monitored.
Slovenian: Prav tako je treba pri bolnicah skrbno spremljati krvni tlak.
English: The PRAC also considered the available data on the efficacy of these products;
Slovenian: Prav tako je proučil tudi razpoložljive podatke o učinkovitosti teh zdravil;
English: The analysis of case reports from the literature was hampered by the limited information available.
Slovenian: Analiza poročil o primerih iz literature je bila ovirana zaradi omejenih razpoložljivih podatkov.
English: Nevertheless, further information and awareness among the healthcare professionals is advisable to ensure safe use of the product.
Slovenian: Kljub temu se priporočajo dodatne informacije in osveščanje zdravstvenih delavcev, da se zagotovi varna uporaba zdravila.
English: Overall summary of the scientific evaluation of bromocriptine containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo bromokriptin (glejte Prilogo I)
English: In the European Union (EU) it is also used to treat other conditions, such as hyperprolactinaemia and Parkinson's disease; however these indications are not in the scope of this European review.
Slovenian: V Evropski uniji (EU) se uporablja tudi za zdravljenje bolezni, kot sta hiperprolaktinemija in Parkinsonova bolezen, vendar ti dve indikaciji ne spadata v sklop tega evropskega pregleda.
English: This is considered an appropriate risk minimisation measure to reduce the misuse of the product.
Slovenian: To naj bi bil primeren ukrep za zmanjšanje tveganja, da se zmanjša napačna uporaba zdravila.
English: Indeed, as per the posology one dose given should not exceed 2.5 mg.
Slovenian: Dejansko v skladu z navodili za odmerjanje en dani odmerek ne sme biti večji od 2,5 mg.
English: From the pathogenic point of view, it is likely that vasospasm is responsible for these events.
Slovenian: Z vidika patogenosti je verjetno, da je bil vzrok za te dogodke vazospazem.
English: If any symptoms of hypertension or evidence of central nervous system toxicity are detected, the administration of bromocriptine should be discontinued;
Slovenian: Če se odkrijejo kakršni koli simptomi hipertenzije ali znaki toksičnih učinkov na osrednji živčni sistem, je treba uporabo bromokriptina prekiniti;
English: 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%.
Slovenian: 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 %.
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.
Slovenian: 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.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: 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).
Slovenian: 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).
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.
Slovenian: 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.
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).
Slovenian: 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 %).
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).
Slovenian: 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).
English: The PRAC concluded that these should not be mentioned in the product information as examples of situations where bromocriptine could be used.
Slovenian: Odbor PRAC je zaključil, da te indikacije ne smejo biti navedene v informacijah o zdravilu med primeri okoliščin, v katerih se bromokriptin lahko uporablja.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Bromocriptine is used to prevent or suppress lactation in women who have given birth.
Slovenian: Bromokriptin se uporablja za preprečevanje ali zaviranje laktacije pri ženskah po porodu.
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.
Slovenian: Čeprav nekateri dejavniki kažejo na vzročno povezavo med dogodki in bromokriptinom, so v poporodnem obdobju prisotni neodvisni dejavniki tveganja za tovrstne dogodke.
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.
Slovenian: 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.
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).
Slovenian: 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),
English: Clinical studies and published literature supported the use of bromocriptine in prevention or suppression of physiological lactation in post-partum.
Slovenian: Klinične študije in objavljena literatura podpirajo uporabo bromokriptina za preprečevanje ali zaviranje fiziološke laktacije po porodu.
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.
Slovenian: 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.
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.
Slovenian: Ob upoštevanju mehanizma uravnavanja laktacije in rezultatov teh študij je odbor PRAC menil, da je bila učinkovitost bromokriptina pri zaviranju laktacije zadovoljivo dokazana.
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:
Slovenian: 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:
English: 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).
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: • 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.
English: Therefore the PRAC recommended that safety information be included in the SmPC across the Member States.
Slovenian: Odbor PRAC je zato priporočil, da se v vseh državah članicah v povzetek glavnih značilnosti zdravila vključijo informacije o varnosti.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: • 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Overall, considering the substantial exposure to this active substance, the PRAC considered the number of cases as low.
Slovenian: Na splošno je odbor PRAC menil, da je glede na precejšnjo izpostavljenost tej zdravilni učinkovini število primerov majhno.