FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmaceutical legislation defines the tests that must be carried out to demonstrate that the generic medicine is comparable to the reference medicine so that it can receive a marketing authorisation.
Slovenian: Farmacevtska zakonodaja določa teste, ki se morajo izvesti in s katerimi mora biti dokazana primerljivost generičnega zdravila z referenčnim zdravilom, da lahko generično zdravilo pridobi dovoljenje za promet.
English: If specific safety precautions have to be considered when taking the reference medicine, the same precautions will generally also be required for the generic medicine.
Slovenian: Če so pri jemanju referenčnega zdravila potrebni posebni previdnostni ukrepi, je treba običajno enake previdnostne ukrepe upoštevati tudi pri jemanju generičnega zdravila.
English: The inactive ingredients, or ‘excipients', may differ between the generic medicine and its reference.
Slovenian: Neaktivne sestavine ali „pomožne snovi“ se lahko pri generičnem in referenčnem zdravilu razlikujejo.
English: The active substance of a medicine is what gives it its therapeutic effect.
Slovenian: Zdravilna učinkovina zdravila je snov, ki zagotavlja terapevtski učinek zdravila.
English: The only differences relate to any differences in excipients and any patented indications.
Slovenian: Odstopanja se pojavijo le v primeru razlik v zvezi z uporabljenimi pomožnimi snovmi in patentiranimi indikacijami.
English: If the reference medicine is benefiting from patent protection for some indications, these cannot appear in the product information of the generic medicine.
Slovenian: Če so bile pri referenčnem zdravilu s patentnim varstvom zaščitene nekatere indikacije, se te indikacije ne smejo pojaviti v informacijah o generičnem zdravilu.
English: Generic manufacturers can also choose to develop a generic medicine that is based on a reference medicine, but is presented as a different strength or with a different route of administration to the reference medicine.
Slovenian: Izdelovalci generičnih zdravil se lahko odločijo tudi za razvoj generičnega zdravila, ki je osnovano na referenčnem zdravilu, vendar ima drugačno jakost ali drugačno pot uporabe kot referenčno zdravilo.
English: If a generic medicine contains a different salt of the active substance to the salt used in the reference medicine, regulatory authorities will consider whether additional tests are needed for the medicine to be granted a marketing authorisation.
Slovenian: Če generično zdravilo vsebuje drugačno sol zdravilne učinkovine kot referenčno zdravilo, regulativni organi odločijo, ali so potrebni dodatni testi za pridobitev dovoljenja za promet s tem zdravilom.
English: As for other medicines, regulatory authorities perform periodic inspections of the manufacturing site(s), to ensure that good manufacturing practices are in place.
Slovenian: Kot pri vseh drugih zdravilih regulativni organi izvajajo občasne preglede proizvodnih obratov in tako zagotavljajo proizvodnjo v skladu z dobro proizvodno prakso.
English: Once the generic medicine is authorised, the same information will appear in the ‘product information' of the generic medicine (the summary of product characteristics, the labelling and the package leaflet) as in the product information of the reference medicine.
Slovenian: Po odobritvi generičnega zdravila so v informacijah o tem zdravilu (povzetku glavnih značilnosti zdravila, označevanju in navodilu za uporabo) navedeni enaki podatki kot v informacijah o referenčnem zdravilu.
English: How is the safety of generic medicines monitored?
Slovenian: Kako se spremlja varnost generičnih zdravil?
English: As for all medicines, generic medicines must obtain a marketing authorisation before they can be marketed.
Slovenian: Kot vsa druga zdravila morajo tudi generična zdravila pred trženjem pridobiti dovoljenje za promet.
English: While this ‘use patent' protection is in place, a generic medicine cannot be marketed for the protected indication, even if the period of exclusivity on the reference medicine has expired.
Slovenian: Med veljavnostjo „patenta za uporabo“ se generično zdravilo ne sme tržiti za zaščiteno indikacijo, tudi če je obdobje zaščite za referenčno zdravilo že poteklo.
English: Innovator companies can use patent law to obtain further protection for an innovative medicine.
Slovenian: Družbe, ki razvijejo inovativna zdravila, lahko ta dodatno zaščitijo s patentnim varstvom.
English: Marketing authorisations are granted after a regulatory authority, such as the European Medicines Agency, has conducted a scientific evaluation of the medicine's efficacy (how well it works as measured in clinical studies), safety and quality.
Slovenian: Evropska agencija za zdravila, izvede znanstveno vrednotenje učinkovitosti (kako učinkovito je zdravilo glede na rezultate kliničnih študij), varnosti in kakovosti zdravila.
English: A company can only develop a generic medicine for marketing once the period of ‘exclusivity' on the reference medicine has expired.
Slovenian: Družba lahko generično zdravilo za trženje razvije šele po izteku „zaščite“ za referenčno zdravilo.
English: A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s) as the reference medicine.
Slovenian: Generično zdravilo vsebuje enako(e) zdravilno(e) učinkovino(e) kot referenčno zdravilo in se v enakem odmerku uporablja za zdravljenje enake(ih) bolezni kot referenčno zdravilo.
English: This period of exclusivity is given by law to the company that developed the innovative medicine on which the generic medicine is based.
Slovenian: Obdobje zaščite je za družbo, ki razvije inovativno zdravilo, na podlagi katerega se zasnuje generično zdravilo, določeno z zakonom.
English: A generic medicine contains the same quantity of active substance(s) as the reference medicine.
Slovenian: Generično zdravilo vsebuje enako količino zdravilne(ih) učinkovine (učinkovin) kot referenčno zdravilo.
English: If precautions are necessary because of an excipient, they will be described both on the label and in the package leaflet of the generic medicine.
Slovenian: Če so zaradi določene pomožne snovi potrebni previdnostni ukrepi, bodo ti opisani na ovojnini in v navodilu za uporabo generičnega zdravila.
English: Questions and answers on generic medicines
Slovenian: Vprašanja in odgovori o generičnih zdravilih EMA/393905/2006 Rev 2
English: What is a generic medicine?
Slovenian: Kaj je generično zdravilo?
English: How are generic medicines authorised?
Slovenian: Kako se generična zdravila odobrijo?
English: How are generic medicines manufactured?
Slovenian: Kako se generična zdravila izdelujejo?
English: What does a generic medicine contain?
Slovenian: Kaj generično zdravilo vsebuje?
English: How are generic medicines evaluated?
Slovenian: Kako se generična zdravila vrednotijo?
English: 2 pre-filled syringes
Slovenian: 2 napolnjena injekcijska peresnika
English: The PRAC issued its final recommendations on 17 May 2018, replacing the temporary measures.
Slovenian: Odbor PRAC je 17. maja 2018 izdal končna priporočila, ki nadomeščajo začasne ukrepe.
English: 1 June 2018 EMA/355940/2018
Slovenian: EMA/482522/2018
English: The review of Esmya was initiated at the request of European Commission on 30 November 2017, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Esmya se je začel 30. novembra 2017 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: It is estimated that around 765,000 patients have been treated with Esmya to date.
Slovenian: Ocenjuje se, da se je do zdaj z zdravilom Esmya zdravilo približno 765 000 bolnic.
English: The PRAC therefore recommended that use of the medicine should be restricted.
Slovenian: Odbor PRAC je zato priporočil, da je treba uporabo zdravila omejiti.
English: • If you have any questions or concern about your treatment, speak to your doctor or pharmacist.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke glede zdravljenja, se posvetujte z zdravnikom ali farmacevtom.
English: Liver testing also to be performed again 2-4 weeks after stopping treatment.
Slovenian: Preiskave delovanja jeter je treba ponovno opraviti 2-4 tedne po prenehanju zdravljenja.
English: More information on Esmya can be found here.
Slovenian: Več informacij o zdravilu Esmya je na voljo tukaj.
English: In case of signs or symptoms suggestive of such injury, treatment should be stopped.
Slovenian: V primeru znakov ali simptomov, ki kažejo na tovrstno okvaro, je treba zdravljenje prekiniti.
English: While the review was ongoing, the PRAC had issued temporary recommendations that no new patients should start treatment.
Slovenian: Med potekom pregleda je odbor PRAC izdal začasna priporočila, po katerih zdravljenja ne sme začeti nobena nova bolnica.
English: In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.
Slovenian: Poleg tega je uporaba zdravila za več kot en ciklus zdravljenja omejena na ženske, ki niso primerne za kirurški poseg.
English: Although uncertainties around causality remain, the following measures to minimise a possible risk for liver injury will be introduced:
Slovenian: Čeprav negotovosti glede vzročne povezave ostajajo, so bili uvedeni naslednji ukrepi za zmanjšanje morebitnega tveganja za okvaro jeter:
English: − Liver function tests to be performed before starting each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated.
Slovenian: − Preiskave delovanja jeter je treba opravljati pred začetkom vsakega ciklusa zdravljenja, mesečno v prvih dveh ciklusih zdravljenja, nato pa, kot je klinično indicirano.
English: − Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN).
Slovenian: − Zdravilo Esmya se ne sme uvesti, če so ravni alanin-transaminaze (ALT) ali aspartataminotransferaze (AST) več kot dvakrat višje od zgornje meje normalne vrednosti (ULN).
English: • You will also have liver tests during treatment and after treatment has stopped.
Slovenian: • Jetrne preiskave boste imeli tudi med zdravljenjem in po prenehanju zdravljenja.
English: The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
Slovenian: Zdravilo je dokazano učinkovito pri zmanjševanju krvavenja in anemije, povezanih s to boleznijo, ter pri zmanjševanju velikosti leiomiomov.
English: • Esmya will not be prescribed to you if you have liver problems.
Slovenian: • Zdravila Esmya vam ne bodo predpisali, če imate težave z jetri.
English: Patients should be investigated immediately including liver function testing.
Slovenian: Bolnice morajo takoj opraviti preiskave, vključno s preiskavami delovanja jeter.
English: Certain women may start treatment with Esmya once the new measures are implemented.
Slovenian: Določene ženske se po uvedbi novih ukrepov lahko začnejo zdraviti z zdravilom Esmya.
English: No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.
Slovenian: Pri uporabi zdravila ellaOne niso poročali o primerih resne okvare jeter in trenutno ni zadržkov glede uporabe tega zdravila.
English: It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.
Slovenian: Priporočljiva je tudi izvedba študij za ugotavljanje učinkov zdravila Esmya na jetra in učinkovitosti novih ukrepov pri zmanjšanju tveganja.
English: The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury.
Slovenian: Ukrepi vključujejo: kontraindikacijo pri ženskah z znanimi težavami z jetri, jetrne preiskave pred uvedbo zdravljenja, med zdravljenjem in po koncu zdravljenja, kartico za bolnice, s katero se seznanijo o potrebi po spremljanju delovanja jeter in obveznosti, naj se obrnejo na zdravnika, če se pri njih pojavijo simptomi okvare jeter.
English: • Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.
Slovenian: • Zdravstveni delavci, ki predpisujejo zdravilo Esmya v EU, so prejeli dopis z dodatnimi podrobnostmi.
English: • A card will be included in the package of the medicine with information on the risk of liver injury and the need for liver monitoring.
Slovenian: • Pakiranju zdravila bo priložena kartica z informacijami o tveganju za okvaro jeter in o potrebi po spremljanju delovanja jeter.
English: In 8 cases of serious liver injury, a role of Esmya in contributing to these cases is possible.
Slovenian: V osmih primerih resne poškodbe jeter obstaja možnost, da je k tem prispevalo zdravilo Esmya.
English: • Healthcare professionals should advise their patients about the signs and symptoms of liver injury and the action to take should they occur.
Slovenian: • Zdravstveni delavci morajo svojim bolnicam povedati, kakšni so znaki in simptomi okvare jeter, in jim svetovati, kako naj ukrepajo, če se ti pojavijo.
English: The PRAC's final recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Slovenian: Končna priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Slovenian: Pregled je opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Slovenian: Ker lahko progesteron spodbuja rast leiomiomov, ulipristalacetat s preprečevanjem njegovega učinka zmanjša velikost leiomiomov.
English: The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.1
Slovenian: Odbor PRAC je zaključil, da je zdravilo Esmya morda prispevalo k pojavu nekaterih primerov resne okvare jeter.1
English: Esmya: new measures to minimise risk of rare but serious liver injury
Slovenian: Zdravilo Esmya: novi ukrepi za zmanjšanje tveganja za redko, a resno okvaro jeter
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Slovenian: Ulipristalacetat je učinkovina tudi v enoodmernem zdravilu ellaOne, odobrenem za nujno kontracepcijo.
English: − Restricted indication in the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: Esmya should only be used in women who are not eligible for surgical treatment.
Slovenian: − Omejitev indikacije na intermitentno zdravljenje zmernih do resnih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi: zdravilo Esmya se sme uporabljati samo pri ženskah, ki niso primerne za kirurško zdravljenje.
English: − Contraindication in patients with underlying liver disorders.
Slovenian: − Kontraindikacija pri bolnicah z osnovno boleznijo jeter.
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Slovenian: Učinkovina v zdravilu Esmya, ulipristalacetat, deluje tako, da se na celicah veže na običajna prijemališča (receptorje) za vezavo hormona progesterona, kar prepreči učinek progesterona.
English: The review of Esmya was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation.
Slovenian: Pregled zdravila Esmya je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji EMA po poročilih o resni okvari jeter, vključno z odpovedjo jeter, zaradi katere je bila potrebna presaditev.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 26.07.2018 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
English: (Esmya continues to be indicated for one course (lasting up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.)
Slovenian: (Zdravilo Esmya je še naprej indicirano za en ciklus [ki traja največ tri mesece] predoperativnega zdravljenja zmernih do resnih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi.)
English: • A liver test will be performed before you start treatment and if the test is abnormal, treatment with Esmya will not be started.
Slovenian: • Pred začetkom zdravljenja bodo opravili preiskavo jeter in v primeru nenormalnih izvidov zdravljenja z zdravilom Esmya ne bodo uvedli.
English: The PRAC's recommendations have now been endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je podprl priporočila odbora PRAC in jih poslal Evropski komisiji v sprejetje končnega pravnega sklepa.
English: A letter will be sent to doctors to inform them of the new conditions of use, which will become applicable after a Commission decision is issued.
Slovenian: Zdravnikom je bil poslan dopis, s katerim so bili seznanjeni z novimi pogoji uporabe.
English: The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate).
Slovenian: Evropska agencija za zdravila (EMA) je 31. maja 2018 priporočila uvedbo ukrepov za zmanjšanje tveganja za redko, a resno okvaro jeter pri uporabi zdravila Esmya (ulipristalacetata).
English: • The medicine Esmya, used to treat uterine fibroids, has been reviewed because cases of serious liver problems have occurred in women taking the medicine, including four cases that resulted in liver transplantation.
Slovenian: • Zdravilo Esmya, ki se uporablja za zdravljenje materničnih leiomiomov, je bilo pregledano, ker so se pri ženskah, ki so jemale zdravilo, pojavili primeri resnih težav z jetri, vključno s štirimi primeri, pri katerih je bila potrebna presaditev jeter.
English: EMA concludes review of medicine for uterine fibroids
Slovenian: Agencija EMA zaključuje pregled zdravila za maternične leiomiome
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are benign (non-cancerous) tumours of the womb, in women who have not reached the menopause.
Slovenian: Zdravilo Esmya je bilo leta 2012 odobreno za zdravljenje zmernih do hudih simptomov materničnih leiomiomov, tj. benignih (nerakavih) tumorjev maternice pri ženskah pred menopavzo.
English: − Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN.
Slovenian: − Pri bolnicah z ravnmi ALT ali AST, ki so več kot trikrat višje od zgornje meje normalne vrednosti, je treba zdravljenje prekiniti.
English: • You should stop treatment and contact your doctor immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
Slovenian: • Če se pojavijo simptomi okvare jeter (kot so utrujenost, porumenelost kože, temno obarvan urin, siljenje na bruhanje in bruhanje), morate takoj prekiniti zdravljenje in se obrniti na zdravnika.
English: Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb).
Slovenian: Zdravilo Esmya uporablja za zdravljenje zmernih do hudih simptomov materničnih leiomiomov (benignih tumorjev maternice).
English: • If no liver problems are detected, a single course of Esmya can be used in women who are about to have surgery for their fibroids; Esmya can be used for more than one course only in women who cannot have surgery.
Slovenian: • Če ne odkrijejo nobenih težav z jetri, se pri ženskah, ki imajo načrtovan kirurški poseg zaradi leiomiomov, lahko opravi en ciklus zdravljenja z zdravilom Esmya.
English: • Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
Slovenian: • Pri bolnicah, zdravljenih z zdravilom Esmya (ulipristalacetatom), so poročali o štirih primerih resne okvare jeter, zaradi katere je bila potrebna presaditev, ter o dodatnih primerih okvare jeter.
English: ATCvet code: QI05AD02.
Slovenian: ATCvet oznaka: QI05AD02.
English: Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Slovenian: Datum pridobitve dovoljenja za promet: 06/03/2003 Datum zadnjega podaljšanja dovoljenja za promet: 06/03/2013
English: 10x1 ml (10 doses).
Slovenian: 10x1ml (10 odmerkov)
English: EXP Use immediately after opening.
Slovenian: EXP Uporabite takoj po prvem odpiranju.
English: Do not use after the expiry date stated on the label.
Slovenian: Ne uporabljajte po pretečenem roku uporabnosti, navedenem na nalepki
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Slovenian: V izjemnih okoliščinah lahko pride do preobčutljivostne reakcije, ki jo je treba ustrezno simptomatično zdraviti.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini.
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: Stranski učinki (pogostost in resnost)
English: The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Slovenian: Učinkovine biološkega izvora namenjene vzbujanju aktivne pasivne imunosti, niso vključene v Uredbo(ES) št. 470/2009.
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Slovenian: * vCP vsebnost določena s celokupnim FAID50 (fluorescenčni test infektivnega odmerka 50 %) in qPCR razmerjem med vCP.
English: A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Slovenian: Rahlo povišanje temperature (največ 1,5 °C) lahko traja 1 dan, izjemoma 2 dni.
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Slovenian: MERIAL, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
English: Manufacturer responsible for the batch release: MERIAL
Slovenian: Izdelovalec, odgovoren za sprostitev serije: MERIAL
English: • 5 months after primary vaccination course with ProteqFlu-Te.
Slovenian: • 5 mesecev po primarnem cepljenju s Proteqflu TE.
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Slovenian: Aktivna imunizacija konj, starih 4 mesece ali več proti konjski influenci za ublažitev kliničnih znakov in zmanjšanje izločanja virusov po okužbi.
English: In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Slovenian: V izjemnih okoliščinah se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek.