FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: • 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.
English: Furthermore, in part of the cases important risk factors (smoking, obesity, pre-eclampsia, hypertension, history of psychiatric episodes) were reported.
Slovenian: Poleg tega so v nekaterih primerih poročali o pomembnih dejavnikih tveganja (kot so kajenje, debelost, preeklampsija, hipertenzija in epizode psihiatričnih motenj v anamnezi).
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: A range of adverse events have been reported, including depression, psychosis, myocardial infarction, stroke, intracranial haemorrhage, thrombotic events, convulsions, and hypertension.
Slovenian: Poročali so o vrsti različnih neželenih dogodkov, med katerimi so bili depresija, psihoza, miokardni infarkt, možganska kap, intrakranialna krvavitev, trombotični dogodki, konvulzije in hipertenzija.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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;
Slovenian: • 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;
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.
Slovenian: 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.
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.
Slovenian: Sočasno so v Franciji po prvi nacionalni raziskavi farmakovigilance, ki je pokazala, da srčno-žilni neželeni učinki zdravila predstavljajo pomemben delež prijavljenih neželenih dogodkov, dopolnili povzetek glavnih značilnosti zdravila z informacijami glede teh neželenih učinkov.
English: In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Slovenian: Pri nekaterih bolnicah so bili pred pojavom epileptičnih napadov ali možganske kapi prisotni hudi glavoboli in/ali prehodne motnje vida.
English: In addition, the PRAC was of the view that the contra-indication in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancyinduced hypertension), hypertension post-partum and in the puerperium, and patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders, already partially in place in most member states should be implemented across all Member States.
Slovenian: Poleg tega je odbor PRAC menil, da je kontraindikacijo pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju ter pri bolnicah z boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali s simptomi/anamnezo hudih psihiatričnih motenj, ki je delno že v veljavi v večini držav članic, treba izvajati v vseh državah članicah.
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.
Slovenian: Na podlagi razpoložljivih podatkov je bilo zaključeno, da vzročne povezave med uporabo bromokriptina in resnimi srčno-žilnimi, nevrološkimi in psihiatričnimi dogodki ni mogoče izključiti.
English: • In addition, the PRAC recommended all strengths of these products to be contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and puerperium as well as in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders;
Slovenian: • poleg tega je odbor PRAC priporočil, da se vse jakosti teh zdravil kontraindicirajo pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju ter pri bolnicah z boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali s simptomi/anamnezo hudih psihiatričnih motenj;
English: The PRAC reviewed the efficacy and safety data following oral treatment with bromocriptine in postpartum inhibition of lactation, in particular data related to the risk of cardiovascular, vascular neurological and psychiatric adverse events.
Slovenian: Odbor PRAC je pregledal podatke o učinkovitosti in varnosti peroralnega zdravljenja z bromokriptinom za zaviranje laktacije po porodu, zlasti podatke v zvezi s tveganjem za srčno-žilne, nevrovaskularne in psihiatrične neželene dogodke.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of oral bromocriptine-containing medicinal products in the post-partum inhibition of lactation identified in Annex I remains favourable, subject to the agreed changes to the product information including restrictions and warnings.
Slovenian: Posledično je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu ter so navedena v Prilogi I, še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu, vključno z omejitvami in opozorili.
English: For that reason the PRAC considered that to avoid medication errors or misuse of the products the indication of inhibition of lactation should be removed from the PI of the 5 mg and 10 mg strengths.
Slovenian: Odbor PRAC je zato menil, da je za preprečitev napak pri zdravljenju ali napačne uporabe zdravil indikacijo zaviranja laktacije treba izbrisati iz informacij o zdravilu za jakosti 5 mg in 10 mg.
English: Avoiding the elective use of this drug in patients with pregnancy-induced hypertension might constitute a reasonable clinical response to these findings.
Slovenian: Smiseln klinični odgovor na te ugotovitve bi lahko bil izogibanje elektivni uporabi tega zdravila pri bolnicah s hipertenzijo zaradi nosečnosti.
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.
Slovenian: Odbor PRAC je proučil povezavo med uporabo zdravil za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, ter pojavom resnih srčno-žilnih, nevroloških in psihiatričnih neželenih dogodkov.
English: Finally, the PRAC considered that, to avoid medication errors or misuse, the indication for inhibition of post-partum lactation, should be removed from the product information of the 5 mg and 10 mg strengths.
Slovenian: Odbor PRAC je menil še, da je za preprečitev napak pri zdravljenju ali napačne uporabe indikacijo zaviranja laktacije po porodu treba izbrisati iz informacij o zdravilu za jakosti 5 mg in 10 mg.
English: The marketing authorisation was renewed on 13 March 2002 and on 13 March 2007.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 13. marca 2002 in 13. marca 2007.
English: Other information about Refludan:
Slovenian: Druge informacije o zdravilu Refludan:
English: The marketing authorisation holder is Celgene Europe Ltd.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Celgene Europe Ltd.
English: The recommended dose is 0.4 mg per kilogram body weight as a single injection into a vein, followed by a continuous infusion at a dose of 0.15 mg/kg per hour for two to 10 days, or longer if needed.
Slovenian: Priporočeni odmerek je 0,4 mg na kilogram telesne mase z eno injekcijo v veno, ki ji sledi neprekinjena intravenska infuzija v odmerku 0,15 mg/kg telesne mase na uro, ki traja od 2 do 10 dni ali celo dlje, če je to potrebno.
English: What benefit has Refludan shown during the studies?
Slovenian: Kakšne koristi je zdravilo Refludan izkazalo med študijami?
English: During the study period, 9% of the patients died (11 out of 125), 6% had amputations (7 out of 125) and 10% had new thromboembolic complications (12 out of 125).
Slovenian: V času študije je umrlo 9 % bolnikov (11 od 125), 6 % jih je moralo na amputacijo (7 od 125), 10 % bolnikov pa je imelo nove tromboembolične zaplete (12 od 125).
English: Some patients can have a serious allergic shock when they receive Refludan for a second time.
Slovenian: Pri nekaterih bolnikih lahko pride do hudega alergijskega šoka, ko zdravilo Refludan prejmejo drugič zapovrstjo.
English: It must not be used in patients who are pregnant or breast-feeding.
Slovenian: Ne sme se uporabljati pri nosečnicah ali doječih materah.
English: Bleeding leading to death occurs in around 1 patient in 100.
Slovenian: Do krvavitev, katerih posledica je smrt bolnika, pride pri približno 1 bolniku od 100.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Refludan on 13 March 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Refludan, veljavno po vsej Evropski uniji, odobrila dne 13. marca 1997.
English: Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and thromboembolic disease.
Slovenian: Zdravilo Refludan so preučevali v dveh glavnih študijah, v katerih je sodelovalo 198 bolnikov, med katerimi jih je 125 imelo HIT in tromboembolijo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REFLUDAN EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) REFLUDAN Povzetek EPAR za javnost
English: As the disease is very severe and there are no other effective treatments approved, the Committee for Medicinal Products for Human Use (CHMP) decided that Refludan's benefits are greater than its risks for the treatment of patients with HIT and thromboembolic disease.
Slovenian: Ker je bolezen zelo huda in zanjo ne obstajajo nobena druga odobrena učinkovita zdravila, je Odbor za zdravila za uporabo v humani medicini (CHMP) zaključil, da so koristi zdravila Refludan pri zdravljenju bolnikov s HIT in tromboembolijo večje od z njim povezanih tveganj.
English: The studies did not compare Refludan with any other treatments, so the results were judged against historical controls (the results expected in untreated patients, based on past studies).
Slovenian: V teh študijah zdravila Refludan niso primerjali z drugimi oblikami zdravljenja, zato so njune rezultate ovrednotili v primerjavi s historičnimi raziskavami (pričakovanimi rezultati pri nezdravljenih bolnikih, ki temeljijo na preteklih študijah).
English: What is the risk associated with Refludan?
Slovenian: Kakšna tveganja so povezana z zdravilom Refludan?
English: Refludan is used to prevent blood clotting.
Slovenian: Refludan se uporablja za preprečevanje krvnih strdkov.
English: The Committee recommended that Refludan be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Refludan odobri dovoljenje za promet.
English: In the comparison with historical controls, the two trials taken together showed a significant benefit of Refludan on the rate of new thromboembolic complications and a trend towards increased survival.
Slovenian: V primerjavi s historičnimi raziskavami sta obe študiji skupaj pokazali znatno korist zdravila Refludan pri zmanjševanju pogostosti novih tromboemboličnih zapletov in trend podaljševanja preživetja.
English: Doctors should be very careful when re-exposing a patient to the medicine.
Slovenian: Zdravniki morajo zato biti zelo pozorni, kadar bolnika ponovno zdravijo s tem zdravilom.
English: By blocking thrombin, Refludan greatly reduces the risk of blood clots forming, preventing subsequent damage.
Slovenian: Z blokiranje trombina zdravilo Refludan bistveno zmanjša tveganje za nastanek krvnih strdkov, s čimer preprečuje nadaljnje okvare.
English: Its use is not advisable in patients who are bleeding or are at risk of bleeding because of a recent biopsy, stroke or major surgery, or because they are over the age of 65 years, among other reasons.
Slovenian: Uporaba zdravila ni priporočljiva pri bolnikih, ki trenutno krvavijo ali pri katerih obstaja tveganje za pojav krvavitve zaradi nedavne biopsije, kapi ali večje operacije ali ki so starejši od 65 let.
English: The diagnosis must be confirmed using specific tests, such as the heparin-induced platelet aggregation assay (HIPAA) test.
Slovenian: Diagnozo je treba potrditi s posebnimi testi, kot je denimo test aktivacije trombocitov s heparinsko indukcijo (HIPAA).
English: It contains the active substance lepirudin.
Slovenian: Vsebuje zdravilno učinkovino lepirudin.
English: Lepirudin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce lepirudin.
Slovenian: Lepirudin proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK) s katerim lahko tvori lepirudin.
English: See the Package Leaflet for the full list of restrictions.
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: It is used in adults with heparin-induced thrombocytopenia (HIT, a type of allergy to heparin that causes a lack of platelets in the blood or clots in the blood vessels) and who have thromboembolic disease (abnormal development of blood clots) that needs injected anti-clotting treatment, usually heparin.
Slovenian: Uporablja se pri odraslih bolnikih, ki imajo s heparinom inducirano trombocitopenijo (HIT, določeno vrsto alergije na heparin, ki povzroča pomanjkanje trombocitov v krvi ali strdke v krvnih žilah), in bolnikih s tromboembolijo (nenormalno tvorbo krvnih strdkov), ki zahteva zdravljenje proti strdkom z injiciranjem zdravila, ponavadi heparina.
English: As with other antithrombotic drugs, the most common side effect with Refludan (seen in more than 1 patient in 10) is bleeding.
Slovenian: Kot pri vseh ostalih antitrombotičnih zdravilih so najpogostejši neželeni učinek zdravila Refludan (opaženi pri več kot 1 bolniku izmed 10) krvavitve.
English: The doses need to be reduced in patients with kidney problems.
Slovenian: Pri bolnikih z ledvičnimi težavami morajo biti odmerki nižji.
English: Refludan should not be used in people who may be hypersensitive (allergic) to lepirudin, any other hirudin derivative, or any of the other ingredients.
Slovenian: Zdravila Refludan ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) lepirudin, katerikoli drugi derivat hirudina ali katero koli drugo sestavino zdravila.
English: Lepirudin specifically blocks a substance called thrombin, which is central for the complete process of blood clotting.
Slovenian: Lepirudin specifično zavira delovanje snovi, imenovane trombin, ki ima osrednjo vlogo v procesu strjevanja krvi.
English: Refludan is an antithrombotic medicine (a medicine that prevents the blood from clotting).
Slovenian: Zdravilo Refludan je antitrombotično zdravilo (zdravilo, ki preprečuje strjevanje krvi).
English: Why has Refludan been approved?
Slovenian: Zakaj je bilo zdravilo Refludan odobreno?
English: For the full list of all side effects reported with Refludan, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Refludan, glejte navodilo za uporabo.
English: Refludan is a powder that is dissolved to make up a solution for injection or infusion (drip into a vein).
Slovenian: Zdravilo Refludan je prašek za pripravo raztopine za injiciranje ali infundiranje (kapalno infuzijo v veno).
English: The full EPAR for Refludan is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Refludan je na voljo tukaj.
English: What is Refludan used for?
Slovenian: Za kaj se zdravilo Refludan uporablja?
English: The active substance in Refludan, lepirudin, is nearly identical to hirudin, the anti-clotting substance produced by leeches.
Slovenian: Zdravilna učinkovina v zdravili Refludan, lepirudin, je skoraj popolnoma enaka hirudinu, snovi, ki zavira strjevanje krvi in ki jo proizvajajo pijavke.
English: How is Refludan used?
Slovenian: Kako se zdravilo Refludan uporablja?
English: How has Refludan been studied?
Slovenian: Kako je bilo zdravilo Refludan raziskano?
English: What is Refludan?
Slovenian: Kaj je zdravilo Refludan?
English: The studies looked at the numbers of patients who died, had an amputation, and had new thromboembolic (clotting) complications.
Slovenian: prestalo amputacijo in imelo nove tromboembolične zaplete (zaplete zaradi krvnih strdkov).
English: Treatment with Refludan should be started by a doctor who has experience in the treatment of coagulation (clotting) disorders.
Slovenian: ki ima izkušnje z zdravljenjem koagulacijskih motenj (motenj strjevanja krvi).
English: How does Refludan work?
Slovenian: Kako zdravilo Refludan deluje?
English: Isolated limb perfusion (intra-arterial use)
Slovenian: Izolirana perfuzija okončine (intraarterijska uporaba)
English: Powder for solution for infusion
Slovenian: 1 mg Prašek za raztopino za infundiranje
English: vial (glass)
Slovenian: viala (steklenica) 1 mg
English: MA (EU) number Invented name Strength Pharmaceutical form
Slovenian: Številka (EU) dovoljenja za promet
English: Allergic reactions have been reported with these medicines.
Slovenian: Pri teh zdravilih so poročali o alergijskih reakcijah.
English: Primula flower EMA/423706/2016EMA/423706/2016
Slovenian: EMA/423706/2016
English: Primula veris L. and/or Primula elatior (L.) Hill, flos
Slovenian: Primula veris L. in/ali Primula elatior (L.) Hill, flos
English: Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Slovenian: Zdravila, ki vsebujejo cvet jegliča, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
English: What is primula flower?
Slovenian: Kaj je cvet jegliča?
English: If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified
Slovenian: Če simptomi med uporabo zdravila trajajo več kot en teden ali se poslabšajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/423706/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.