FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/06/373/001 7 film-coated tablets EU/1/06/373/002 14 film-coated tablets EU/1/06/373/003 28 film-coated tablets EU/1/06/373/004 30 film-coated tablets EU/1/06/373/005 56 film-coated tablets EU/1/06/373/006 90 film-coated tablets EU/1/06/373/007 98 film-coated tablets EU/1/06/373/008 280 film-coated tablets EU/1/06/373/025 56x1 film-coated tablet (unit dose) EU/1/06/373/026 98x1 film-coated tablet (unit dose) EU/1/06/373/027 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/373/001 7 filmsko obloženih tablet EU/1/06/373/002 14 filmsko obloženih tablet EU/1/06/373/003 28 filmsko obloženih tablet EU/1/06/373/004 30 filmsko obloženih tablet EU/1/06/373/005 56 filmsko obloženih tablet EU/1/06/373/006 90 filmsko obloženih tablet EU/1/06/373/007 98 filmsko obloženih tablet EU/1/06/373/008 280 filmsko obloženih tablet EU/1/06/373/025 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/026 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/027 280x1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/06/373/017 7 film-coated tablets EU/1/06/373/018 14 film-coated tablets EU/1/06/373/019 28 film-coated tablets EU/1/06/373/020 30 film-coated tablets EU/1/06/373/021 56 film-coated tablets EU/1/06/373/022 90 film-coated tablets EU/1/06/373/023 98 film-coated tablets EU/1/06/373/024 280 film-coated tablets EU/1/06/373/031 56x1 film-coated tablet (unit dose) EU/1/06/373/032 98x1 film-coated tablet (unit dose) EU/1/06/373/033 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/373/017 7 filmsko obloženih tablet EU/1/06/373/018 14 filmsko obloženih tablet EU/1/06/373/019 28 filmsko obloženih tablet EU/1/06/373/020 30 filmsko obloženih tablet EU/1/06/373/021 56 filmsko obloženih tablet EU/1/06/373/022 90 filmsko obloženih tablet EU/1/06/373/023 98 filmsko obloženih tablet EU/1/06/373/024 280 filmsko obloženih tablet EU/1/06/373/031 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/032 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/033 280x1 filmsko obložena tableta (za enkratni odmerek)
English: Pancreatitis
Slovenian: Izdelovalec
English: EU/1/06/373/009 7 film-coated tablets EU/1/06/373/010 14 film-coated tablets EU/1/06/373/011 28 film-coated tablets EU/1/06/373/012 30 film-coated tablets EU/1/06/373/013 56 film-coated tablets EU/1/06/373/014 90 film-coated tablets EU/1/06/373/015 98 film-coated tablets EU/1/06/373/016 280 film-coated tablets EU/1/06/373/028 56x1 film-coated tablet (unit dose) EU/1/06/373/029 98x1 film-coated tablet (unit dose) EU/1/06/373/030 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/373/009 7 filmsko obloženih tablet EU/1/06/373/010 14 filmsko obloženih tablet EU/1/06/373/011 28 filmsko obloženih tablet EU/1/06/373/012 30 filmsko obloženih tablet EU/1/06/373/013 56 filmsko obloženih tablet EU/1/06/373/014 90 filmsko obloženih tablet EU/1/06/373/015 98 filmsko obloženih tablet EU/1/06/373/016 280 filmsko obloženih tablet EU/1/06/373/028 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/029 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/373/030 280x1 filmsko obložena tableta (za enkratni odmerek)
English: Uncommon Uncommon Not known Uncommon Very rare
Slovenian: Bolezni imunskega sistema preobčutljivost redki zelo redki pogostnost neznana
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Imprida in vsebina pakiranja
English: Hepatic impairment
Slovenian: Očesne bolezni redki
English: Not known Very rare Not known
Slovenian: Žilne bolezni pogosti redki zelo redki pogostnost neznana
English: Uncommon Very rare Uncommon Uncommon
Slovenian: Bolezni imunskega sistema redki zelo redki pogostnost neznana
English: Oedema peripheral
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta redki
English: • If you have any questions or concerns, speak to your doctor, pharmacist or nurse.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The rate can then be increased but should not exceed 15 mg/h.
Slovenian: Hitrost infundiranja se nato lahko poveča, vendar ne sme preseči 15 mg/h.
English: When the target blood pressure is reached, the dose should be reduced progressively.
Slovenian: Ko je dosežen ciljni krvni tlak, je treba odmerek postopoma zmanjšati.
English: The review of intravenous nicardipine was initiated in July 2012 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled intravenskega nikardipina se je začel julija 2012 na zahtevo Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
English: These uses are no longer recommended because the available data are insufficient to support use in these conditions.
Slovenian: Uporaba v teh okoliščinah ni več priporočljiva, saj razpoložljivi podatki niso zadostni, da bi podprli tovrstno uporabo.
English: Medicines containing nicardipine given into a vein are authorised in the following EU Member States: Belgium, France, Luxemburg, the Netherlands and Spain.
Slovenian: Zdravila, ki vsebujejo nikardipin in se dajejo v veno, so odobrena v naslednjih državah članicah EU: v Belgiji, Franciji, Luksemburgu, na Nizozemskem in v Španiji.
English: The CHMP recommendation was sent to the European Commission, which issued a final decision on 20 December 2013.
Slovenian: Odbor CHMP je priporočilo posredoval Evropski komisiji, ki je dne 20. decembra 2013 izdala končni sklep.
English: The MHRA therefore decided to request an EU-wide review of these medicines.
Slovenian: Posledično se je MHRA odločila, da bo zahtevala presojo teh zdravil po vsej EU.
English: The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications.
Slovenian: MHRA je menila, da predloženi klinični podatki niso bili zadostni za določitev razmerja med tveganji in koristmi generičnega zdravila pri predlaganih indikacijah.
English: It works as a ‘calcium-channel blocker': this means that it blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Slovenian: Deluje kot „zaviralec kalcijevih kanalčkov“, kar pomeni, da zavira določene kanalčke na površini celic, ki jih imenujemo kalcijevi kanalčki in skozi katere v celice običajno vstopajo kalcijevi ioni.
English: In adults, treatment should start with a continuous administration of nicardipine at a rate of 3-5 mg/h.
Slovenian: Pri odraslih je zdravljenje treba začeti z neprekinjenim infundiranjem nikardipina s hitrostjo 3-5 mg/h.
English: − malignant arterial hypertension/hypertensive encephalopathy;
Slovenian: − pri maligni arterijski hipertenziji/hipertenzivni encefalopatiji;
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 20 December 2013.
Slovenian: Odbor CHMP je mnenje posredoval Evropski komisiji, ki ga je potrdila in dne 20. decembra 2013 sprejela končni pravno zavezujoči sklep, ki velja za celotno EU.
English: It also noted that medicines containing nicardipine given intravenously had been authorised in other EU countries but that the authorised uses differed between countries.
Slovenian: Ugotovila je tudi, da so zdravila za intravensko uporabo, ki vsebujejo nikardipin, odobrena tudi v drugih državah EU, vendar se odobrena uporaba v posameznih državah razlikuje.
English: • treatment of post-operative hypertension.
Slovenian: • zdravljenje pooperacijske hipertenzije.
English: • treatment of acute life-threatening hypertension, particularly in the event of:
Slovenian: • zdravljenje akutne, smrtno nevarne hipertenzije, še posebej:
English: − severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated;
Slovenian: − pri hudi preeklampsiji, kadar drugi intravenski antihipertenzivi niso priporočljivi ali so kontraindicirani;
English: • An EU-wide review of medicines containing nicardipine given into a vein has been carried out and recommendations have been given to ensure the safe and effective use of these medicines.
Slovenian: • V EU je bila opravljena presoja zdravil, ki vsebujejo nikardipin in se dajejo v veno, na podlagi katere so bila izdana priporočila za zagotovitev varne in učinkovite uporabe teh zdravil.
English: Nicardipine was also used in some EU countries for controlled hypotension during anaesthesia, for controlling hypertension during surgery and for treating acute severe hypertension with left ventricular decompensation and pulmonary oedema.
Slovenian: Nikardipin se je v nekaterih državah EU uporabljal tudi za nadzorovano hipotenzijo med anestezijo, za nadzorovanje hipertenzije med kirurškim posegom in za zdravljenje akutne hude hipertenzije z dekompenzacijo levega prekata ter pljučnim edemom.
English: The UK medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance of intravenous nicardipine and to issue an opinion on whether the marketing authorisations of these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Slovenian: Agencija Združenega kraljestva za zdravila je odbor CHMP zaprosila, da oceni razmerje med tveganji in koristmi intravenskega nikardipina in izda mnenje o tem, ali naj se dovoljenja za promet s temi zdravili v Evropski uniji ohranijo, spremenijo, začasno umaknejo ali ukinejo.
English: The Agency's Committee on Medicinal Products for Human Use (CHMP) concluded that these medicines should only be used to treat acute (sudden) lifethreatening high blood pressure and to control high blood pressure after an operation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da se lahko ta zdravila uporabljajo samo za zdravljenje akutnega (nenadnega) smrtno nevarnega visokega krvnega tlaka in za uravnavanje visokega krvnega tlaka po operaciji.
English: Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.
Slovenian: Potem ko je ocenil razpoložljive dokaze o varnosti in učinkovitosti intravenskega nikardipina iz objavljenih študij in podatkov iz obdobja trženja, je odbor CHMP zaključil, da so zdravila za intravensko uporabo, ki vsebujejo nikardipin, koristna za zdravljenje visokega krvnega tlaka v določenih okoliščinah, pri čemer mora intervencijo ter spremljanje opraviti specialist.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Slovenian: Ko kalcijevi ioni prodrejo v celice mišic v stenah krvnih žil, se te začnejo krčiti.
English: It should only be administered by specialists in well controlled environments, with continuous monitoring of blood pressure.
Slovenian: Zdravilo lahko daje samo specialist v nadzorovanem okolju in ob stalnem spremljanju krvnega tlaka.
English: Nicardipine should be used with caution and at lower doses in specific patient populations, including patients with liver and kidney problems and children.
Slovenian: Nikardipin je treba pri določenih populacijah bolnikov, kot so na primer bolniki, ki imajo težave z jetri in ledvicami, ter otroci, uporabljati previdno in v manjših odmerkih.
English: • Medicines containing nicardipine given into a vein should be used to treat very severe high blood pressure, or to control high blood pressure after an operation.
Slovenian: • Zdravila, ki vsebujejo nikardipin in se dajejo v veno, se lahko uporabljajo za zdravljenje zelo visokega krvnega tlaka in za uravnavanje visokega krvnega tlaka po operaciji.
English: Use of intravenous nicardipine medicines in other indications is no longer recommended.
Slovenian: Uporaba zdravil za intravensko uporabo, ki vsebujejo nikardipin, pri drugih indikacijah ni več priporočljiva.
English: The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine.
Slovenian: Presojo intravenskega nikardipina je sprožila regulativna agencija Združenega kraljestva za zdravila (MHRA), potem ko je bila v tej državi predložena vloga za generično zdravilo za intravensko uporabo, ki vsebuje nikardipin.
English: The recommended therapeutic indications of intravenous nicardipine are now:
Slovenian: Priporočene terapevtske indikacije intravenskega nikardipina so po novem:
English: Nicardipine is an ‘antihypertensive' medicine that reduces blood pressure by allowing the blood vessels to relax.
Slovenian: Nikardipin je „antihipertenzivno“ zdravilo, ki sprošča krvne žile in s tem zniža krvni tlak.
English: • These medicines will be given to you in hospital as a drip into a vein, and your blood pressure will be regularly monitored.
Slovenian: • Zdravila vam bodo dali v bolnišnici s kapalno infuzijo v veno in stalno spremljali vaš krvni tlak.
English: On 24 October 2013, the European Medicines Agency completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines.
Slovenian: Evropska agencija za zdravila je 24. oktobra 2013 zaključila presojo razmerja med tveganji in koristmi zdravil za intravensko uporabo (dajanje v veno), ki vsebujejo nikardipin.
English: The CHMP also recommended that these medicines should only be given by continuous infusion (drip) into a vein by a specialist in a hospital or intensive care unit.
Slovenian: Odbor CHMP je prav tako priporočil, naj ta zdravila dajejo samo specialisti v bolnišnicah ali enotah za intenzivno nego z neprekinjenim infundiranjem (kapalno infuzijo) v veno.
English: Regarding the posology, nicardipine should be administered by continuous intravenous infusion.
Slovenian: Pri odmerjanju je treba upoštevati, da se mora nikardipin dajati z neprekinjenim intravenskim infundiranjem.
English: Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.
Slovenian: Podrobne informacije o priporočeni uporabi zdravil za intravensko uporabo, ki vsebujejo nikardipin, vključno z navodili za uporabo, so navedene v nadaljevanju.
English: By reducing the flow of calcium into the cells, nicardipine prevents the cells from contracting and this helps the blood vessels to relax.
Slovenian: Nikardipin z zmanjšanjem prehajanja kalcija v celice prepreči krčenje celic in tako pomaga sprostiti krvne žile.
English: − aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective;
Slovenian: ali v kombinaciji z agonistom beta adrenergičnih receptorjev, kadar agonisti beta adrenergičnih receptorjev v obliki monoterapije niso učinkoviti;
English: The EU-wide review of intravenous nicardipine has resulted in updated prescribing information for these medicines.
Slovenian: Na podlagi presoje zdravil za intravensko uporabo, ki vsebujejo nikardipin, opravljene v EU, so bila spremenjena navodila za njihovo predpisovanje.
English: • If you have any questions you should speak to your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se pogovorite z zdravnikom ali farmacevtom.
English: The various iron preparations contain complexes of iron bound to other molecules such as sugar molecules.
Slovenian: Različni pripravki železa vsebujejo komplekse železa, ki se vežejo na druge molekule, kot so molekule sladkorja.
English: The review of intravenous iron-containing medicines was initiated at the request of France, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled intravenskih zdravil, ki vsebujejo železo, je bil sprožen na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
English: The French medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Slovenian: Francoska agencija za zdravila je odbor CHMP prosila za izvedbo polne ocene razmerja med tveganji in koristmi ter za izdajo mnenja o tem, ali naj se dovoljenja za promet s temi zdravili v EU ohranijo, spremenijo, začasno umaknejo ali ukinejo.
English: The Committee therefore concluded that measures should be put in place to ensure the early detection and effective management of allergic reactions that may occur.
Slovenian: Odbor je zato sklenil, da je treba uvesti ukrepe za zagotavljanje zgodnjega odkrivanja in učinkovite obravnave alergijskih reakcij, ki se lahko pojavijo.
English: In addition, the CHMP considered that the current practice of first giving the patient a small test dose is not a reliable way to predict how the patient will respond when the full dose is given.
Slovenian: Poleg tega je odbor CHMP menil, da trenutna praksa, pri kateri bolnik najprej prejme majhen testni odmerek, ni zanesljiv način predvidevanja, kako se bo bolnik odzval na celoten prejeti odmerek.
English: The CHMP concluded that the benefits of these medicines are greater than their risks, provided that adequate measures are taken to minimise the risk of allergic reactions.
Slovenian: Odbor CHMP je sklenil, da so koristi teh zdravil večje od z njimi povezanih tveganj, če se uvedejo primerni ukrepi za zmanjševanje tveganja alergijskih reakcij.
English: • If you have signs of an allergic reaction (such as feeling dizzy, swelling of your face and difficulty breathing), you should tell your doctor or nurse straight away.
Slovenian: • Če imate znake alergijske reakcije (kot je omotica, otekanje obraza in težave z dihanjem), o tem nemudoma obvestite zdravnika ali medicinsko sestro.
English: On 27 June 2013 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) completed its review of intravenous iron-containing medicines used to treat iron deficiency and anaemia (low red blood cell counts) associated with low iron levels.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je 27. junija 2013 končal pregled intravenskih zdravil, ki vsebujejo železo, in se uporabljajo za zdravljenje pomanjkanja železa ter anemije (majhnega števila rdečih krvničk), povezane z nizkimi ravnmi železa.
English: The complexes involved in this procedure were ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside and iron sucrose, which are authorised in all EU Member States via national procedures.
Slovenian: Kompleksi, vključeni v ta postopek, so železova karboksimaltoza, železov dekstran, natrijev železov glukonat, železov izomaltozid in železova saharoza, ki so z nacionalnimi postopki odobreni v vseh državah članicah EU.
English: • As there are data indicating that allergic reactions may still occur in patients who have not reacted to a test dose, a test dose is no longer recommended.
Slovenian: • Ker podatki kažejo, da se lahko alergijske reakcije pojavijo tudi pri bolnikih brez reakcije na testni odmerek, testni odmerek ni več priporočljiv.
English: • All prescribers should inform patients of the risk and seriousness of a hypersensitivity reaction and the importance of seeking medical attention if a reaction occurs.
Slovenian: • Vsi predpisovalci morajo bolnike obvestiti o tveganjih in resnosti preobčutljivostne reakcije ter pomembnosti zdravstvene pomoči, če pride do take reakcije.
English: • Data on the risk of hypersensitivity comes mainly from post-marketing spontaneous reports and the total number of life-threatening and fatal events reported is low.
Slovenian: • Podatki o tveganju za preobčutljivost večinoma izvirajo iz spontanih poročil v obdobju trženja, skupno število poročanih smrtno nevarnih in smrtnih dogodkov pa je majhno.
English: Although the data show a clear association of intravenous iron medicines and hypersensitivity reactions, the data cannot be used to detect any differences in the safety profile of the different iron medicines.
Slovenian: Čeprav podatki kažejo na jasno povezavo med intravenskimi zdravili, ki vsebujejo železo, in preobčutljivostnimi reakcijami, podatkov ni mogoče uporabiti za ugotavljanje kakršnih koli razlik med varnostnimi profili različnih zdravil, ki vsebujejo železo.
English: The CHMP also considered that, during pregnancy, allergic reactions are of particular concern as they can put both the mother and unborn child at risk.
Slovenian: Odbor CHMP je prav tako upošteval, da so alergijske reakcije še posebej nevarne med nosečnostjo, saj lahko mater in nerojenega otroka izpostavijo tveganju.
English: The CHMP recommendation was sent to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Slovenian: Priporočilo odbora CHMP je bilo poslano Evropski komisiji, ki ga je dne 13. septembra 2013 potrdila in sprejela končno pravno zavezujočo odločbo, ki velja za celotno EU.
English: Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the risks to the unborn baby.
Slovenian: Zdravljenje je treba omejiti na drugo ali tretje trimesečje, če so koristi zdravljenja očitno večje od tveganj za nerojenega otroka.
English: New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines
Slovenian: Nova priporočila za obvladovanje tveganja alergijskih reakcij pri intravenskih zdravilih, ki vsebujejo železo
English: The CHMP opinion was forwarded to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Slovenian: Mnenje odbora CHMP je bilo poslano Evropski komisiji, ki ga je dne 13. septembra 2013 potrdila in sprejela končno pravno zavezujočo odločbo, ki velja za celotno EU.
English: You should also tell your doctor if you have certain conditions affecting the immune system and involving inflammation (such as rheumatoid arthritis), a history of asthma, eczema or other allergies, as this may make an allergic reaction to intravenous iron preparations more likely.
Slovenian: Prav tako obvestite zdravnika, če imate nekatera stanja, ki prizadenejo imunski sistem in vključujejo vnetje (kot je revmatoidni artritis), astmo v anamnezi, ekcem ali druge alergije, saj je lahko v teh primerih verjetnost za pojav alergijske reakcije na intravenske pripravke, ki vsebujejo železo, večja.
English: The review of intravenous iron medicines was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following a national review in 2010.
Slovenian: Pregled intravenskih zdravil, ki vsebujejo železo, je po nacionalnem pregledu leta 2010 sprožila francoska agencija za zdravila, Nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM).
English: Iron preparations should only be given in an environment where resuscitation facilities are available, so that patients who develop an allergic reaction can be treated immediately.
Slovenian: Pripravki z železom se smejo dajati samo v okolju, kjer so na voljo prostori in oprema za oživljanje, tako da lahko bolniki, pri katerih se razvije alergijska reakcija, takoj prejmejo zdravljenje.
English: The review highlighted the risk of serious allergic reactions, especially in pregnant women who had received intravenous iron medicines.
Slovenian: V pregledu je bilo izpostavljeno tveganje za resne alergijske reakcije, predvsem pri nosečnicah, ki so prejele intravenska zdravila, ki vsebujejo železo.
English: • The risk of hypersensitivity is increased in patients with known allergies or immune or inflammatory conditions and in patients with a history of severe asthma, eczema or other atopic allergy.
Slovenian: • Tveganje za preobčutljivost je povečano pri bolnikih z znanimi alergijami ali imunskimi ali vnetnimi stanji in bolnikih s hudo astmo, ekcemom ali drugo atopično alergijo v anamnezi.