FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Agency recommended the suspension of Tredaptive, Pelzont or Trevaclyn following the review of new evidence which indicated that the benefits of these medicines no longer outweigh their risks for patients.
Slovenian: • Agencija je po pregledu novih dokazov, ki so pokazali, da koristi teh zdravil niso več večje od z njimi povezanih tveganj za bolnike, priporočila začasen umik zdravil Tredaptive, Pelzont in Trevaclyn.
English: 85-619 Bydgoszcz Poland
Slovenian: 85-619 Bydgoszcz Poljska
English: Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Slovenian: Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španija
English: 92931 Paris La Défense Cedex France
Slovenian: 92931 Paris La Défense Cedex Francija
English: Nicergolin tablet
Slovenian: Nicergolin tableta
English: Via Scarlatti Domenico, 31 20124 Milano Italy
Slovenian: Via Scarlatti Domenico, 31 20124 Milano Italija
English: Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich United Kingdom
Slovenian: Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich Velika Britanija
English: Industriestrasse 25, D-83607 Holzkirchen, Germany
Slovenian: Industriestrasse 25, D-83607 Holzkirchen, Nemčija
English: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy
Slovenian: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italija
English: Angenerico spa Via Nocera Umbra, 75 00181 Roma Italy
Slovenian: Angenerico spa Via Nocera Umbra, 75 00181 Roma Italija
English: B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romania
Slovenian: B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romunija
English: S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romania
Slovenian: S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romunija
English: Ergotop 10 mgTabletten tablet
Slovenian: Ergotop 10 mgTabletten tableta
English: SERMION 5 mg, poudre pour solution pour perfusion powder for solution for infusion intravenous use
Slovenian: SERMION 5 mg, poudre pour solution pour perfusion prašek za raztopino za infundiranje intravenska uporaba
English: s r.o., Praha Stroupežnického 17
Slovenian: s r.o., Praha Stroupežnického 17 150 00 Prague 5
English: Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenia
Slovenian: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenija
English: NICERGOLINA SANDOZ 30 mg tablet
Slovenian: NICERGOLINA SANDOZ 30 mg tableta
English: 4 mg/4 ml powder and solvent for solution for injection intramuscular and intravenous use
Slovenian: 4 mg/4 ml prašek in vehikel za raztopino za injiciranje intramuskularna in intravenska uporaba
English: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy
Slovenian: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italija
English: Kwizda Pharma GmbH Effingergasse 21 1160 Vienna Austria
Slovenian: Kwizda Pharma GmbH Effingergasse 21
English: Nicergolin powder and solvent for solution for injection intramuscular use intravenous use
Slovenian: Nicergolin prašek in vehikel za raztopino za injiciranje intramuskularna uporaba intravenska uporaba
English: NICERGOLINA SANDOZ 30 mg effervescent tablet oral use
Slovenian: NICERGOLINA SANDOZ 30 mg šumeča tableta peroralna uporaba
English: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy soluble tablet
Slovenian: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italija tableta za peroralno raztopino
English: 10 mg/ml powder and solvente per oral solution
Slovenian: 10 mg/ml prašek in vehikel za peroralno raztopino
English: Modifiedrelease capsule, hard
Slovenian: NICERIUM® 30 UNO 30 mg kapsula s prirejenim sproščanjem, trda
English: 25 October 2013 EMA/565019/2013
Slovenian: 23. oktober 2013 EMA/565019/2013
English: Healthcare professionals will be informed in writing of the updated recommendations.
Slovenian: Zdravstvene delavce bodo o posodobljenih priporočilih obvestili v pisni obliki.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Te podatke je najprej pregledal Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: The review of short-acting beta-agonists was initiated in November 2012 at the request of the Hungarian medicines agency, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled kratkodelujočih agonistov beta-adrenergičnih receptorjev je bil sprožen novembra 2012 na zahtevo madžarske agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
English: The medicines are called ‘short acting' because they work quickly, usually having an effect in less than five minutes, which lasts for several hours.
Slovenian: Zdravila se imenujejo „kratkodelujoča“, ker delujejo hitro, saj se učinek navadno pojavi po manj kot petih minutah, traja pa več ur.
English: It proposed revising their prescribing information, with reinforced warnings on the cardiovascular risks.
Slovenian: Predlagal je ponovni pregled informacij za predpisovanje, s poudarkom na opozorilih glede kardiovaskularnih tveganj.
English: This timeframe can allow healthcare professionals to take other measures known to improve the health of the baby around the time of birth.
Slovenian: Ta časovni okvir zdravstvenim delavcem omogoča, da uvedejo druge ukrepe, za katere je znano, da izboljšajo zdravje otroka ob času poroda.
English: The reviewed data originated from clinical studies, post-marketing reports and the published literature.
Slovenian: Pregledani podatki izvirajo iz kliničnih študij, poročil v obdobju trženja in objavljene literature.
English: Short-acting beta-agonists have been authorised by national procedures in several European Union (EU) Member States, and have been marketed for many years under various trade names.
Slovenian: Kratkodelujoči agonisti beta-adrenergičnih receptorjev so bili z nacionalnimi postopki odobreni v več državah članicah Evropske unije (EU) in so na trgu že mnoga leta pod različnimi trgovskimi imeni.
English: The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours).
Slovenian: Razpoložljivi podatki kažejo, da so oblike za injiciranje učinkovite pri kratkotrajnem zaviranju porodnih popadkov (do 48 ur).
English: • If you are given these medicines for premature labour in this way, your doctor will monitor you and your baby during treatment and stop treatment if there are any signs of heart problems.
Slovenian: • Če ta zdravila prejmete za zaviranje prezgodnjega poroda na ta način, bo zdravnik med zdravljenjem spremljal vas in vašega otroka ter prekinil zdravljenje, če se pojavijo kakršni koli znaki srčnih težav.
English: Oral and suppository formulations which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Slovenian: Dovoljenja za promet s peroralnimi formulacijami in svečkami, ki so trenutno odobrene samo za porodniške indikacije, bodo preklicana, ta zdravila pa bodo imetniki dovoljenj za promet z zdravili umaknili s tržišča najpozneje do 25. novembra 2013.
English: However, injectable forms of these medicines can still be given for short-term obstetric use under specific conditions.
Slovenian: Oblike teh zdravil za injiciranje pa so še vedno dovoljene za kratkotrajno porodniško uporabo pod posebnimi pogoji.
English: However, their use should be limited to pregnant women between 22 and 37 weeks of gestation and women receiving these medicines should be kept under specialist supervision for the duration of treatment, which is limited to a maximum of 48 hours.
Slovenian: Vendar pa je treba njihovo uporabo omejiti na obdobje med 22. in 37. tednom nosečnosti, ženske, ki prejemajo ta zdravila, pa morajo biti pod specialističnim nadzorom celotno zdravljenje, ki je omejeno na največ 48 ur.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus new recommendations to restrict the use of medicines called ‘short-acting beta-agonists'.
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)1 je soglasno podprla nova priporočila za omejitev uporabe zdravil, imenovanih „kratkodelujoči agonisti beta-adrenergičnih receptorjev“.
English: As short-acting beta-agonists are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Ker so vsi kratkodelujoči agonisti beta-adrenergičnih receptorjev odobreni na nacionalni ravni, so bila priporočila odbora PRAC poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh).
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where these medicines are authorised.
Slovenian: Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih so ta zdravila odobrena.
English: Smooth muscle is found in many organs, including on the inner linings of the airways, blood vessels, stomach and gut, and womb.
Slovenian: Gladke mišice so v mnogih organih, vključno z notranjimi plastmi dihal, krvnimi žilami, želodcem, črevesjem in maternico.
English: • These medicines can still be given intravenously (into a vein) to suppress premature labour, but their use is limited to a maximum of 48 hours, and only in women between the 22nd and the 37th weeks of pregnancy.
Slovenian: • Ta zdravila se še vedno lahko dajejo intravensko (v veno) za zaviranje prezgodnjega poroda, vendar je njihova uporaba omejena na največ 48 ur in samo med 22. ter 37. tednom nosečnosti.
English: As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej neposredno izvajale vse države članice v skladu z dogovorjenim časovnim razporedom.
English: Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Slovenian: Odbor PRAC je zato sklenil, da so koristi teh oblik za injiciranje še vedno večje od tveganj, če se uporabljajo pod posebnimi pogoji: ta zdravila se smejo uporabljati samo za zaviranje prezgodnjega poroda do 48 ur, med 22. in 37. tednom nosečnosti in pod specialističnim nadzorom s stalnim spremljanjem matere ter nerojenega otroka.
English: These medicines should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions.
Slovenian: Ta zdravila se v peroralnih oblikah ali svečkah ne smejo več uporabljati pri porodniških indikacijah (za oskrbo nosečnic), kot je zaviranje prezgodnjega poroda ali čezmernih porodnih popadkov.
English: The medicines included in the EU review are: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline, which have been authorised for tocolytic treatment (to suppress labour contractions).
Slovenian: Zdravila, vključena v pregled EU, so: fenoterol, heksoprenalin, izoksuprin, ritodrin, salbutamol in terbutalin, ki so bila odobrena za tokolitično zdravljenje (za zaviranje porodnih popadkov).
English: Short-acting beta-agonists work by stimulating a receptor on the surface of cells called the ‘beta-2 adrenergic receptor', which brings about smooth muscle relaxation.
Slovenian: Kratkodelujoči agonisti beta-adrenergičnih receptorjev delujejo tako, da spodbujajo receptorje na površini celic, imenovane „beta-2 adrenergični receptorji“, kar povzroča sproščanje gladkih mišic.
English: In countries where injectable forms are also authorised for external cephalic version (a method for moving the baby into the right position for birth) and emergency use in specific conditions, the PRAC
Slovenian: V državah, kjer so oblike za injiciranje odobrene tudi za zunanji obrat (metodo za premik otroka v pravilni položaj za
English: These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Slovenian: Ta priporočila upoštevajo pregled razpoložljivih kardiovaskularnih varnostnih podatkov o fenoterolu, heksoprenalinu, izoksuprinu, ritodrinu, salbutamolu in terbutalinu, kadar se uporabljajo pri porodniških indikacijah.
English: These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Slovenian: Ta priporočila upoštevajo pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in s katerim so preučili znana tveganja za kardiovaskularne neželene učinke (težave, ki prizadenejo srce in krvne žile) pri velikih odmerkih kratkodelujočih agonistov beta-adrenergičnih receptorjev, če se uporabljajo kot tokolitiki (zdravila, ki zavirajo porodne popadke).
English: In addition to oral medicines and suppositories, this review also covered injectable short-acting betaagonists used as tocolytics.
Slovenian: Poleg peroralnih zdravil in svečk je ta pregled vključeval tudi kratkodelujoče agoniste betaadrenergičnih receptorjev za injiciranje, ki se uporabljajo kot tokolitiki.
English: Given the cardiovascular risk and the very limited data on the effectiveness of the oral and suppository forms of these medicines, the PRAC concluded that their benefit-risk balance is not favourable and these medicines should no longer be used in obstetric indications.
Slovenian: Na podlagi kardiovaskularnega tveganja in zelo omejenih podatkov o učinkovitosti peroralnih oblik teh zdravil ter svečk je odbor PRAC sklenil, da razmerje med tveganji in koristmi ni ugodno, zato se ta zdravila ne smejo več uporabljati pri porodniških indikacijah.
English: They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Slovenian: Na voljo so v obliki tablet, peroralnih raztopin, raztopin za injiciranje ali infundiranje in svečk.
English: • Parenteral short-acting beta-agonists are effective in the short-term and they can still be used in all authorised obstetric indications (inhibition of premature labour, external cephalic version, emergency use in specified conditions).
Slovenian: • Parenteralni kratkodelujoči agonisti beta-adrenergičnih receptorjev so učinkoviti pri kratkotrajnem zdravljenju, zato se lahko še vedno uporabljajo pri vseh odobrenih porodniških indikacijah (zaviranju prezgodnjega poroda, zunanjem obratu, urgentni uporabi pri posebnih pogojih).
English: • Parenteral short-acting beta-agonists should not be used in women with a history of heart disease or significant risk factors for heart disease or when prolongation of the pregnancy is hazardous to mother or fetus.
Slovenian: • Parenteralni kratkodelujoči agonisti beta-adrenergičnih receptorjev se ne smejo uporabljati pri ženskah s srčno boleznijo v anamnezi ali pomembnimi dejavniki tveganja za srčno bolezen ali kadar je podaljšanje nosečnosti nevarno za mater ali plod.
English: • Given the identified cardiovascular adverse reaction profile and the very limited data supporting the benefits of oral forms and suppositories as short or long-term tocolytics, these formulations should no longer be used in any obstetric indication.
Slovenian: • Glede na ugotovljeni profil kardiovaskularnih neželenih učinkov in zelo omejene podatke, ki podpirajo koristi peroralnih oblik ter svečk kot kratko- ali dolgotrajnih tokolitikov, se te formulacije ne smejo več uporabljati pri nobenih porodniških indikacijah.
English: The PRAC concluded that there was a risk of serious cardiovascular side effects to both the mother and unborn baby when high-dose short-acting beta-agonists are used in obstetric indications, with the data suggesting these mostly occur with prolonged use.
Slovenian: Odbor PRAC je sklenil, da je prisotno tveganje za resne kardiovaskularne neželene učinke na mater in nerojenega otroka, kadar se veliki odmerki kratkodelujočih agonistov beta-adrenergičnih receptorjev uporabljajo pri porodniških indikacijah, pri čemer podatki kažejo, da se ti večinoma pojavijo pri dolgotrajni uporabi.
English: • Because of a risk of problems affecting the heart and circulation to both the mother and unborn baby with high-dose short-acting beta-agonists, these medicines must not be used by mouth or as suppositories to suppress premature labour in pregnant women.
Slovenian: • Zaradi tveganja za težave, ki prizadenejo srce in ožilje pri materi in nerojenem otroku, pri velikih odmerkih kratkodelujočih agonistov beta-adrenergičnih receptorjev se ta zdravila v peroralni obliki ali v obliki svečk ne smejo uporabljati za zaviranje prezgodnjega poroda pri nosečnicah.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States recommended that they remain authorised in these indications.
Slovenian: CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
English: • High-dose short-acting beta-agonists are associated with a risk of serious adverse cardiovascular events to both the mother and the fetus, particularly when used for a prolonged period of time.
Slovenian: • Veliki odmerki kratkodelujočih agonistov beta-adrenergičnih receptorjev so povezani s tveganjem za resne kardiovaskularne neželene učinke na mater in plod, predvsem če se uporabljajo dolgotrajno.
English: • Although these medicines are also used for the treatment of asthma, they are usually given at lower doses for this condition; if you are being treated with short-acting beta-agonists and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Slovenian: Če se zdravite s kratkodelujočimi agonisti beta-adrenergičnih receptorjev in imate kakršna koli vprašanja ali pomisleke glede zdravljenja, se posvetujte z zdravnikom ali farmacevtom.
English: Content (concentration)
Slovenian: Izmišljeno ime ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija) velikost pakiranja
English: Similar results were seen in adults and in children.
Slovenian: Pri odraslih in otrocih so bili opaženi podobni rezultati.
English: It contains the active substance emedastine (0.5 mg/ml).
Slovenian: Vsebuje zdravilno učinkovino emedastin (0,5 mg/ml).
English: Emadine emedastine
Slovenian: Emadine emedastin
English: Its effects have not been studied beyond six weeks.
Slovenian: Učinkov zdravila niso preučevali v preizkušanjih, daljših od šest tednov.
English: The results of the allergen challenge tests supported these results.
Slovenian: Rezultati testov izpostavljenosti alergenom so te zaključke potrdili.
English: These symptoms include itching, redness and swelling.
Slovenian: Ti simptomi vključujejo srbenje, pordelost in otekanje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emadine, veljavno po vsej Evropski uniji, izdala 27. januarja 1999.
English: The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje srbenja in pordelosti, ocenjeno na 9-točkovni lestvici v obdobju šestih tednov.
English: This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Slovenian: Gre za test, pri katerem bolniki z alergijo, ki trenutno ne kažejo simptomov alergije, prejmejo določeno dozo alergena (snovi, na katero so alergični), da bi se sprožila alergijska reakcija.
English: Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Slovenian: Zdravilo Emadine ni priporočljivo za bolnike, starejše od 65 let ali za bolnike, ki imajo težave z jetri ali ledvicami.
English: The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Emadine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Emadine is used in adults and children aged three years and older.
Slovenian: Zdravilo Emadine se uporablja pri odraslih in otrocih, starejših od treh let.
English: This is a summary of the European public assessment report (EPAR) for Emadine.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emadine.
English: Other information about Emadine
Slovenian: Druge informacije o zdravilu Emadine
English: For more information about treatment with Emadine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Emadine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Slovenian: Če so receptorji blokirani, histamin ne more učinkovati, zaradi česar se simptomi alergije zmanjšajo.
English: The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Slovenian: Steklenička zdravila Emadine vsebuje benzalkonijev klorid, za katerega je znano, da razbarva mehke kontaktne leče.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emadine.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Slovenian: Če bolnik uporablja več vrst zdravil za oči, jih je treba uporabiti v razmiku vsaj desetih minut.
English: The Committee recommended that Emadine be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Emadine izda dovoljenje za promet.
English: Emadine is given as one drop in the affected eye(s) twice a day.
Slovenian: Odmerek zdravila Emadine je ena kapljica v prizadeto oko (očesi) dvakrat na dan.
English: The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge'.
Slovenian: Družba je prav tako predstavila dognanja študij, v katerih so bolniki prejemali zdravilo Emadine, levokabastin ali placebo (zdravilo brez zdravilne učinkovine), preden so jih izpostavili alergenom.
English: What benefit has Emadine shown during the studies?
Slovenian: Kakšne koristi je zdravilo Emadine izkazalo med študijami?
English: The active substance in Emadine, emedastine, is an antihistamine.
Slovenian: Zdravilna učinkovina zdravila Emadine, emedastin, je antihistaminik.