FrancophonIA/ELRC3.0 huggingface dataset:
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Slovenian: Tovrstna presaditev se uporablja pri bolnikih, ki potrebujejo zamenjavo krvotvornih celic, ker imajo krvno bolezen (na primer redko vrsto anemije) ali krvnega raka.
English: The company provided data from the published literature on busulfan.
Slovenian: Družba je predstavila podatke o busulfanu iz objavljene literature.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (‘stem') cells (cells that make other types of cell).
Slovenian: To pomeni, da uničujejo celice, še zlasti pa hitro razvijajoče se celice, kot so na primer rakave ali progenitorske („matične“) celice (celice, ki tvorijo druge vrste celic).
English: The full EPAR and risk management plan summary for Busulfan Fresenius Kabi 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) in povzetek načrta obvladovanja tveganj za zdravilo Busulfan Fresenius Kabi sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Busulfan Fresenius Kabi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Busulfan Fresenius Kabi has been shown to be comparable to Busilvex.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da je zdravilo Busulfan Fresenius Kabi primerljivo z zdravilom Busilvex.
English: It is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Slovenian: Uporablja se pri odraslih in otrocih kot del pripravljalnega zdravljenja pred presaditvijo krvotvornih matičnih celic (celic, ki tvorijo krvne celice).
English: The medicine is available as a concentrate to be made up into a solution for central intravenous infusion (drip into a central vein in the chest).
Slovenian: Zdravilo je na voljo v obliki koncentrata za pripravo raztopine za infundiranje skozi osrednji venski kateter (kapalne infuzije v osrednjo veno v prsnem košu).
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Slovenian: Nato se za zaviranje delovanja imunskega sistema uporabijo ciklofosfamid, melfalan ali fludarabin, s čimer se zmanjša naravna obramba telesa.
English: Before receiving Busulfan Fresenius Kabi, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Slovenian: Preden bolniki prejmejo zdravilo Busulfan Fresenius Kabi, dobijo zdravila proti konvulzijam (za preprečevanje epileptičnih napadov) in antiemetike (za preprečevanje bruhanja).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Busulfan Fresenius Kabi on 22 September 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Busulfan Fresenius Kabi, veljavno po vsej Evropski uniji, izdala 22. septembra 2014.
English: Because Busulfan Fresenius Kabi is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker se zdravilo Busulfan Fresenius Kabi daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing bloodmaking cells.
Slovenian: Zdravilo Busulfan Fresenius Kabi se uporablja pred presaditvijo, da se uničijo nenormalne celice in obstoječe bolnikove krvotvorne celice.
English: The Committee recommended that Busulfan Fresenius Kabi be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Busulfan Fresenius Kabi odobri za uporabo v EU.
English: Busulfan Fresenius Kabi can only be obtained with a prescription and should only be used by a doctor who has experience in treatments given before transplantation.
Slovenian: Izdaja zdravila Busulfan Fresenius Kabi je le na recept, uporabljajo pa ga lahko samo zdravniki, ki imajo izkušnje z zdravili, ki se dajejo pred presaditvijo.
English: What measures are being taken to ensure the safe and effective use of Busulfan Fresenius Kabi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Busulfan Fresenius Kabi?
English: This means that Busulfan Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Busilvex.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Busilvex.
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busulfan Fresenius Kabi is given right after treatment with another medicine, fludarabine.
Slovenian: Pri odraslih bolnikih, ki so primerni za pripravljalni režim zdravljenja z zmanjšano jakostjo zdravila, se zdravilo Busulfan Fresenius Kabi daje neposredno po zdravljenju z drugim zdravilom, fludarabinom.
English: For more information about treatment with Busulfan Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Busulfan Fresenius Kabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Slovenian: Kadar se zdravilo Busulfan Fresenius Kabi uporablja v kombinaciji s fludarabinom, znaša priporočeni odmerek 3,2 mg/kg in se daje enkrat na dan kot triurna infuzija dva ali tri dni zapored neposredno po uporabi fludarabina.
English: Busulfan Fresenius Kabi is a ‘generic medicine'.
Slovenian: Zdravilo Busulfan Fresenius Kabi je „generično zdravilo“.
English: For a conventional conditioning treatment, Busulfan Fresenius Kabi is given before treatment with a second medicine, cyclophosphamide in adults, and either cyclophosphamide or melphalan in children.
Slovenian: V okviru konvencionalnega pripravljalnega zdravljenja se zdravilo Busulfan Fresenius Kabi uporablja pred začetkom zdravljenja z drugim zdravilom, in sicer pri odraslih pred ciklofosfamidom, pri otrocih pa bodisi pred ciklofosfamidom ali melfalanom.
English: What are the benefits and risks of Busulfan Fresenius Kabi?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Busulfan Fresenius Kabi?
English: A risk management plan has been developed to ensure that Busulfan Fresenius Kabi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Busulfan Fresenius Kabi je bil pripravljen načrt obvladovanja tveganj.
English: For practical information about using Busulfan Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Busulfan Fresenius Kabi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Busulfan Fresenius Kabi
Slovenian: Druge informacije o zdravilu Busulfan Fresenius Kabi
English: Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan.
Slovenian: Busulfan Fresenius Kabi je zdravilo, ki vsebuje zdravilno učinkovino busulfan.
English: The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Slovenian: Zdravilna učinkovina v zdravilu Busulfan Fresenius Kabi, busulfan, spada v skupino zdravil, ki se imenujejo „alkilirajoči citostatiki“.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busulfan Fresenius Kabi in adults is 0.8 mg per kilogram body weight.
Slovenian: Kadar se zdravilo Busulfan Fresenius Kabi uporablja v kombinaciji s ciklofosfamidom ali melfalanom, znaša njegov priporočeni odmerek pri odraslih 0,8 mg na kilogram telesne mase.
English: What is Busulfan Fresenius Kabi and what is it used for?
Slovenian: Kaj je zdravilo Busulfan Fresenius Kabi in za kaj se uporablja?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Therefore, the CHMP's view was that, as for Busilvex, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Busilvex odtehtajo znana tveganja.
English: Why is Busulfan Fresenius Kabi approved?
Slovenian: Zakaj je bilo zdravilo Busulfan Fresenius Kabi odobreno?
English: How has Busulfan Fresenius Kabi been studied?
Slovenian: Kako je bilo zdravilo Busulfan Fresenius Kabi raziskano?
English: How is Busulfan Fresenius Kabi used?
Slovenian: Kako se zdravilo Busulfan Fresenius Kabi uporablja?
English: No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
Slovenian: Ker je zdravilo Busulfan Fresenius Kabi generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo, Busilvex, dodatne študije niso bile potrebne.
English: In children up to 17 years of age, the recommended dose of Busulfan Fresenius Kabi varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Slovenian: Vsaka infuzija traja dve uri, bolnik pa jo prejme vsakih šest ur štiri dni zapored pred zdravljenjem s ciklofosfamidom ali melfalanom in presaditvijo.
English: How does Busulfan Fresenius Kabi work?
Slovenian: Kako zdravilo Busulfan Fresenius Kabi deluje?
English: In addition, H2 receptor antagonists have a more immediate effect.
Slovenian: Poleg tega imajo antagonisti receptorjev H2 hitrejši učinek.
English: Regarding Section 4.1, the CHMP adopted the following harmonised indication:
Slovenian: V zvezi s poglavjem 4.1 je CHMP sprejel naslednjo usklajeno indikacijo:
English: The mention of erosions was therefore deleted from the indication.
Slovenian: Omembo erozije so zato izbrisali iz indikacije.
English: Further information on recommended antibiotic combinations is stated in Section 4.2.
Slovenian: Dodatni podatki o priporočenih kombinacijah antibiotikov so navedeni v poglavju 4.2.
English: In line with the indication, this product should not be used in children.
Slovenian: V skladu z indikacijo se to zdravilo ne sme uporabljati za otroke.
English: The intravenous indications were largely harmonised already.
Slovenian: Indikacije za intravensko uporabo so bile že v večji meri usklajene.
English: In children over 1 year of age and ≥ 10 kg
Slovenian: Otroci, starejši od 1 leta in s telesno maso ≥10 kg
English: For the elderly (>65 years old), no dose adjustment is needed.
Slovenian: Pri starostnikih (>65 let) prilagajanje odmerka ni potrebno.
English: Special populations: all formulations
Slovenian: Posebne skupine bolnikov: vse formulacije
English: Patients are also told not to take omeprazole as a preventive medication.
Slovenian: Bolnike se tudi pouči, da ne smejo jemati omeprazola kot preventivno zdravilo.
English: The conditions of the Marketing Authorisations are described in Annex IV.
Slovenian: Pogoji dovoljenja za promet so navedeni v Dodatku IV.
English: Alternatively, patients can suck the capsule and swallow the pellets with water.
Slovenian: Drugače pa lahko bolniki kapsulo sesajo in pelete pogoltnejo z vodo.
English: While literature data strongly indicates that there is no cross-reactivity between the various substituted benzimidazoles, there is data indicating suspected cross-reactivity.
Slovenian: Čeprav podatki iz literature jasno kažejo, da ni navzkrižne reaktivnosti med raznimi substituiranimi benzimidazoli, obstajajo tudi podatki, ki kažejo sum navzkrižne reaktivnosti.
English: The CHMP considered that this indication is similar to chemical pneumonia (among others caused by gastric acid aspiration).
Slovenian: CHMP je menil, da je ta indikacija podobna kemijski pljučnici (ki jo med drugim povzroči aspiracija želodčne kisline).
English: When the dose exceeds 80 mg daily, it should be divided and given twice daily.
Slovenian: Če odmerek preseže 80 mg na dan, ga je treba razdeliti in vzeti dvakrat na dan.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LOSEC AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LOSEC IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Powder for infusion and powder for injection
Slovenian: Prašek za infundiranje in prašek za injiciranje
English: There have been no reports of serious outcomes following overdoses with omeprazole, and thus, no specific treatment has been needed or can be recommended.
Slovenian: Poročil o resnih izidih po prevelikem odmerjanju omeprazola ni, zato specifično zdravljenje ni bilo potrebno ali priporočeno.
English: Since such ulcers are difficult to treat and are associated with more frequent and more serious complications, preventing relapse is a reasonable course of action.
Slovenian: Ker je takšne razjede težko zdraviti in ker so povezane s pogostejšimi in resnejšimi zapleti, je preprečevanje ponovitve utemeljen ukrep.
English: Increased gastric pH during omeprazole treatment may affect absorption, while other possible interaction mechanisms are via CYP2C19.
Slovenian: Zvišan želodčni pH med zdravljenjem z omeprazolom morda vpliva na absorpcijo, drugi možni mehanizmi interakcije pa so prek CYP2C19.
English: The CHMP noted that heartburn was not included in the definition of dyspepsia agreed upon by an international committee of clinical investigators (Rome III Committee).
Slovenian: CHMP je ugotovil, da zgaga ni bila vključena v definicijo dispepsije, kakor jo je opredelil mednarodni odbor kliničnih raziskovalcev (Rimski odbor III).
English: Section 4.5 - Interactions with other medicinal products and other forms of interactions - all formulations
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij - vse formulacije
English: Omeprazole has been reported to interact with some antiretroviral drugs.
Slovenian: Poročali so o interakcijah omeprazola z nekaterimi protiretrovirusnimi zdravili.
English: All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of 20-120 mg daily.
Slovenian: Hudo bolezen z neustreznim odzivom na druga zdravljenja so učinkovito obvladovali pri vseh bolnikih in pri več kot 90 % bolnikov so ohranili odmerke 20-120 mg na dan.
English: The known safety profile of omeprazole confirms the absence of direct or indirect danger to human health and the cautionary measures restricting the use to 2 weeks treatment are considered acceptable.
Slovenian: Znani varnostni profil omeprazola potrjuje odsotnost neposredne ali posredne nevarnosti za zdravje človeka, zato se previdnostni ukrep omejitve uporabe na dva tedna zdravljenja šteje za sprejemljivega.
English: Commitments by the MAH were agreed, as listed in the Letter of Undertaking dated 14 December 2009.
Slovenian: Dogovorjene so bile zaveze imetnika dovoljenja za promet z zdravilom, ki so navedene v jamčevalnem pismu z dne 14. decembra 2009.
English: Although this food interaction is not likely to be of any clinical relevance, it warrants the recommendation that Losec should preferably be taken without food.
Slovenian: Čeprav ta interakcija s hrano verjetno nima kliničnega pomena, je utemeljeno priporočilo, da je bolje, če se zdravilo Losec vzame brez hrane.
English: i) Patients considered to be at risk of aspiration of gastric contents during general anaesthesia/Acid aspiration prophylaxis
Slovenian: i) Bolniki, ki so v tveganju za aspiracijo želodčne vsebine med splošno anestezijo/profilaksa aspiracije kisline
English: The MAH submitted a proposal for harmonisation of the Quality module.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil predlog uskladitve modula Kakovost.
English: Such ulcers are also associated with a high frequency of potentially fatal complications.
Slovenian: Takšne razjede so tudi povezane z večjo pogostnostjo možnih zapletov s smrtnim izidom.
English: Initial GERD treatment is managed by a symptom-based approach; an empiric trial of acid suppression can be used.
Slovenian: Začetno zdravljenje GERB se obravnava s pristopom na osnovi simptomov; lahko se uporabi empiričen poskus supresije kisline.
English: The CHMP agreed on the following indications in paediatric patients, in line with the outcome of the EU work-sharing assessment of paediatric data:
Slovenian: CHMP se je strinjal z naslednjimi indikacijami za otroke v skladu z izidom izmenjave vrednotenj pediatričnih podatkov v EU:
English: This section was rewritten in a more reader friendly style by grouping the possible interactions, increasing the visibility of the most severe clinical consequences and indicating the magnitude of the interaction effects.
Slovenian: To poglavje je bilo na novo napisano v bralcu prijaznejšem slogu z razvrstitvijo možnih interakcij v skupine, s povečanjem vidnosti najhujših kliničnih posledic in prikazom pomembnosti učinkov interakcije.
English: OVER THE COUNTER PRESENTATIONS: LOSEC 10 AND 20 MG TABLETS (OTC)
Slovenian: OBLIKE, NA VOLJO BREZ RECEPTA: LOSEC 10 IN 20 MG TABLETE (OTC)
English: However, peptic ulcers and erosions are different clinical entities.
Slovenian: Vendar sta peptična razjeda in erozija drugačna klinična pojava.
English: Concomitant use with posaconazol and erlotinib should be avoided.
Slovenian: Preprečiti je treba sočasno uporabo posakonazola in erlotiniba.
English: The legal status of Losec as a ”medicinal products not subject to medical prescription” was considered to be in accordance with the EC Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use.
Slovenian: Odbor je menil, da je pravni status zdravila Losec kot „zdravila, ki se izdaja brez recepta“ v skladu z Smernico ES o spremembi razvrstitve za oskrbo z zdravili za uporabo v humani medicini.
English: This recommendation is based upon overwhelming data showing that the cure of H. pylori infections reduces ulcer recurrence and complications such as bleeding.
Slovenian: To priporočilo temelji na obsežnih podatkih, ki kažejo, da ozdravitev okužb s H. pylori zmanjša ponovitev razjede in zaplete, kot je krvavitev.
English: However a number of clarifications were requested, mainly with regards to the Manufacture, Control of Drug Product, Container Closure System and Stability sections, for all formulations.
Slovenian: Vendar so bila zahtevana številna pojasnila, zlasti v zvezi s poglavji o izdelavi, kontroli zdravila, sistemu zaporke vsebnika in obstojnosti za vse formulacije.
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - Povzetek glavnih značilnosti zdravil, označevanje in navodilo za uporabo, ki jih predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
English: Salmonella and Campylobacter are mentioned; however the mention of C. difficile infections was removed, as the available data did not establish a possible causal relationship between C. difficile infection and the use of PPIs.
Slovenian: Omenjena sta Salmonella in Campylobacter, izbrisana pa je bila omemba okužb s C. difficile, saj razpoložljivi podatki ne dokazujejo možne vzročnosti med okužbo s C. difficile in uporabo zaviralcev protonske črpalke.
English: The MAH proposed 5 separate SPCs: one for the 10mg, 20 mg, and 40 mg capsules; one for the 10 mg, 20 mg, and 40 mg tablets, one for the 40 mg powder for infusion, one for the 40 mg powder for injection and one for the 10mg and 20 mg tablets for OTC use.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal 5 ločenih povzetkov glavnih značilnosti zdravila: enega za kapsule 10 mg, 20 mg in 40 mg; enega za tablete 10 mg, 20 mg in 40 mg, enega za prašek za infundiranje 40 mg, enega za prašek za injiciranje 40 mg in enega za tablete 10 mg in 20 mg brez recepta.
English: Gastric ulcers in elderly patients may be located more proximally in the stomach than in younger patients.
Slovenian: Razjede želodca se lahko pri starostnikih nahajajo v bolj proksimalnem delu želodca kot pri mlajših bolnikih.
English: Section 4.6: Pregnancy and lactation - all formulations
Slovenian: Poglavje 4.6: Nosečnost in dojenje - vse formulacije
English: The cardinal symptoms associated with GERD are heartburn and regurgitation.
Slovenian: Glavna simptoma, povezana z GERB, sta zgaga in regurgitacija.
English: The data submitted by the MAH did not sufficiently support the claimed indication and although no unexpected or new safety concerns emerged from these studies, the CHMP considered this indication to be unacceptable given the undemonstrated efficacy.
Slovenian: Podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom niso zadostno podprli predlagane indikacije in čeprav v teh študijah ni bilo nepričakovanih ali novih varnostnih zadržkov, je CHMP menil, da je ta indikacija nesprejemljiva zaradi nedokazane učinkovitosti.
English: For children and adolescents over 4 years of age treated for duodenal ulcers caused by H. pylori, the selection of the appropriate combination therapy should take into consideration the official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents.
Slovenian: Pri otrocih, starejših od 4 let, in mladostnikih, ki se zdravijo zaradi razjede dvanajstnika zaradi H. pylori, je treba pri izbiri ustrezne kombinirane terapije upoštevati uradne nacionalne, regionalne in lokalne smernice o odpornosti bakterij, trajanju zdravljenja in ustrezni uporabi protibakterijskih zdravil.
English: Experience on use of intravenous formulations of Losec in paediatric patients is limited, however no specific safety issues are predicted.
Slovenian: Izkušnje z uporabo intravenskih formulacij zdravila Losec pri otrocih so omejene, vendar se ne napovedujejo specifični varnostni zadržki.
English: Based on the European guidelines and literature, and due to the lack of conclusive studies relevant to this indication, this indication and the associated posology was removed from the proposed harmonised SPC.
Slovenian: Na osnovi evropskih smernic in literature ter zaradi pomanjkanja študij z jasnimi zaključki, ki bi bile pomembne za to indikacijo, sta bili ta indikacija ter z njo povezano odmerjanje izbrisani iz predlaganega usklajenega povzetka glavnih značilnosti zdravila.