FrancophonIA/ELRC3.0 huggingface dataset:
English: Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.
Slovenian: Ojačevanje slike se začne 15 do 20 minut po začetku infundiranja in traja približno 4 ure.
English: United Kingdom GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel: + 44 (0) 1 494 54 4000
Slovenian: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas.
Slovenian: Zdravilo TESLASCAN se uporablja pri bolnikih pred magnetno resonančnim slikanjem (MRI), s pomočjo katerega se ugotavljajo lezije (poškodbe tkiva) v jetrih, ki bi jih utegnil povzročiti jetrni rak ali rak, ki se je razširil iz jeter v druge dele telesa.
English: Care should be exercised in patients with severe cardiac disease and in patients with injuries of the blood brain barrier and severe cerebral disease.
Slovenian: Zdravila TESLASCAN se ne sme uporabljati pri nosečnicah ali doječih ženskah, bolnikih s feokromocitomom (tumor nadledvične žleze) ali bolnikih s hudimi težavami z jetri ali ledvicami.
English: Uncommon (1 in 1,000 to 1 in 100 patients experiences the side effect):
Slovenian: Najpogostejši neželeni učinki pri uporabi zdravila TESLASCAN (opaženi pri od 1 do 10 bolnikov od 100) so glavobol, navzeja (občutek slabosti), rdečica in občutek toplote.
English: This corresponds to a dose of 35 ml for a 70 kg person.
Slovenian: Zdravilo TESLASCAN uporabljamo kot enkratno intravensko infuzijo v odmerku, ki znaša 0,5 ml na kilogram telesne mase.
English: TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.
Slovenian: Mangan uporabljamo kot kontrastno sredstvo, ki pri magnetno resonančnem slikanju pomaga ustvariti boljše slike.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the radiologist/radiographer or your doctor or pharmacist.
Slovenian: Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Slovenian: Druge informacije o zdravilu TESLASCAN:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22.05.1997
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 22. maja 2002 in 22. maja 2007.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom TESLASCAN.
English: What TESLASCAN contains - The active substance is mangafodipir trisodium.
Slovenian: Zdravilo TESLASCAN je raztopina za infuzijo (dajanje v veno), ki vsebuje zdravilno učinkovino trinatrijev mangafodipir.
English: Mangafodipir is a chelate containing the metal manganese - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand fodipir (dipyridoxyl diphosphate).
Slovenian: Mangafodipir, ki je zdravilna učinkovina v zdravilu TESLASCAN, vsebuje mangan, element iz skupine kovin.
English: What TESLASCAN is and what it is used for.
Slovenian: Za kaj se zdravilo TESLASCAN uporablja?
English: Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur.
Slovenian: Zdravila TESLASCAN ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) trinatrijev mangafodipir ali katero koli drugo sestavino zdravila.
English: Medicinal product subject to medical prescription.
Slovenian: Zdravilo se dobi samo na recept.
English: Read all of this leaflet carefully before you start using this medicine.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TESLASCAN, glejte Navodilo za uporabo.
English: GE Healthcare Handels GmbH Europlaza, Gebäude E Technologiestrasse 10
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TESLASCAN Povzetek EPAR za javnost
English: TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and
Slovenian: Zdravilo TESLASCAN se lahko uporablja skupaj z magnetno resonančnim slikanjem tudi pri preiskovanju lezij na trebušni slinavki.
English: Pre-clinical studies in rats have established teratogenic effects when TESLASCAN was given repeatedly during major organogenesis.
Slovenian: Magnetno resonančno slikanje, ojačano z zdravilom TESLASCAN, je pri ugotavljanju jetrnih lezij omogočilo ugotoviti več lezij.
English: Pharmacokinetics in the elderly has not been investigated.
Slovenian: Kako je bilo zdravilo TESLASCAN raziskano?
English: Tel: + 43 1 972 72-0
Slovenian: Povzetek je bil nazadnje posodobljen 04-2007.©EMEA 2007
English: Mangafodipir is teratogenic in rats; it causes increased foetal skeletal abnormalities when given daily by intravenous injection to female rats at dosages slightly greater than clinical dosages.
Slovenian: Ko zdravilo vbrizgamo, se mangan sprosti, tega pa zdrava jetra in zdrava tkiva trebušne slinavke vsrkavajo bolje kot rakaste celice.
English: TESLASCAN is for use in patients over the age of 18 years.
Slovenian: Skupaj so med študijami pri 33 % bolnikih po uporabi zdravila TESLASCAN opazili več lezij, 20 % bolnikov pa je imelo v resnici manj lezij.
English: 23 consecutive patients aged 24-139 days (mean 69 days) with prolonged jaundice and lightened stool colour in whom bilary atresia had not been ruled out underwent MR cholangiography with contrast.
Slovenian: V študije bolezni trebušne slinavke je bilo vključenih 292 bolnikov, v njih pa so primerjali učinkovitost magnetno resonančnega slikanja, ojačanega z zdravilom TESLASCAN, ter „spiralne računalniške tomografije (CT)“, ki je še ena diagnostična metoda za odkrivanje lezij trebušne slinavke.
English: These measures will help protect environment.
Slovenian: Ti ukrepi pomagajo varovati okolje.
English: 9 to < 16 16 to 23 > 23 to 34
Slovenian: 9 do < 16 16 do 23 > 23 do 34
English: These risks are assessed in the corresponding national procedures.
Slovenian: Ta tveganja so ocenjena v ustreznih nacionalnih postopkih.
English: Vials: 3 years
Slovenian: Viale: 3 leta
English: The long-term outcomes confirmed that the efficacy was maintained without unexpected effects.
Slovenian: Dolgoročni izidi so potrdili, da se je učinkovitost ohranila brez nepričakovanih učinkov.
English: Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
Slovenian: Datum prve odobritve: 09. julij 2003 Datum zadnjega podaljšanja: 08. julij 2008
English: By example:
Slovenian: Na primer:
English: Therefore careful monitoring will be performed.
Slovenian: Zato boste pod skrbnim nadzorom.
English: Incomplete development of teeth.
Slovenian: Nepopoln razvoj zobovja.
English: During the same period there was no death in autologous recipients.
Slovenian: V istem obdobju pa pri avtolognih prejemnikih ni bilo smrtnega primera.
English: This signal was open based on an isolated case from the literature and no additional cases have been reported.
Slovenian: Signal je bil odprt na osnovi izoliranega primera iz literature, ni poročil o dodatnih primerih.
English: The patients received the dosing mentioned in section 4.2.
Slovenian: Bolniki so prejeli odmerke, omenjene v poglavju 4.2.
English: The signal concerning interaction with deferasirox is refuted and it can be closed.
Slovenian: Signal v zvezi z medsebojnim delovanjem z defarasiroksom je zavrnjen in ga lahko zapremo.
English: PROCEDURE FOR PROPER DISPOSAL
Slovenian: POSTOPEK ZA USTREZNO ODSTRANJEVANJE
English: In new-born infants, children and adolescents (0 to 17 years):
Slovenian: Pri novorojencih, otrocih in mladostnikih (0 do 17 let):
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Disfunkcija spolnih žlez.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve o oddaji redno posodobljenih poročil o varnosti zdravila so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh naknadnih spremembah, objavljene na evropskem spletnem portalu o zdravilih.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če raztopine ne uporabite takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika in ne bi smeli presegati zgoraj navedenih pogojev, če je redčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/254/002
English: Other sources of information
Slovenian: Drugi viri informacji
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zaradi pomanjkanja raziskav kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: * veno occlusive liver disease is more frequent in paediatric population.
Slovenian: * veno-okluzivna jetrna bolezen je pogostejša pri pediatrični populaciji.
English: None of the metabolites is thought to contribute significantly to either efficacy or toxicity.
Slovenian: Noben od presnovkov naj ne bi pomembno prispeval k učinkovitosti ali toksičnosti.
English: Six of 103 patients (6%) experienced HVOD.
Slovenian: Šest od 103 bolnikov (6 %) je izkusilo HVOD.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Slovenian: Pogostost pojavljanja je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: RECOMMENDATION FOR SAFE HANDLING
Slovenian: PRIPOROČILA ZA VARNO RAVNANJE
English: The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Slovenian: Opozorilo za TMA po HCT velja samo za eno farmacevtsko obliko: intravensko.
English: Seven literature reports have been published cumulatively concerning disturbance in dental development.
Slovenian: Kumulativno je bilo v literaturi objavljenih sedem poročil v zvezi z motnjami v razvoju zob.
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Slovenian: 39 % bolnikov (40/103) je izkusilo eno ali več epizod infekcij, od katerih jih je bilo 83 % (33/40) ocenjenih za blage ali zmerne.
English: Two of the above four patients with serious serum hepatotoxicity were among patients with diagnosed HVOD.
Slovenian: Dva od zgoraj naštetih štirih bolnikov z resno serumsko hepatotoksičnostjo sta bila med bolniki z diagnosticirano HVOD.
English: Paediatric population (0 to 17 years)
Slovenian: Pediatrična populacija (od 0 do 17 let)
English: VOD observed were neither fatal nor severe and resolved in all cases.
Slovenian: V nobenem primeru VOD ni bila smrtna ali huda in v vseh primerih je izginila.
English: No pharmacokinetic explanation justifies this interaction.
Slovenian: Ni farmakokinetske razlage, ki bi utemeljila takšno vzajemno delovanje.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v prilogi V.S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: At the recommended dose, this is the desired effect.
Slovenian: Pri priporočenih odmerkih je to želen učinek.
English: Other infections were considered severe in 3% of patients.
Slovenian: Preostale infekcije so bile resne pri 3 % bolnikov.
English: Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
Slovenian: O kronični GVHD so poročali le, če je bila vzrok smrti: en bolnik je umrl 13 mesecev po transplantaciji.
English: Patients should receive adequate anticonvulsant prophylaxis.
Slovenian: Bolnikom je treba zagotoviti zadostno protikonvulzivno profilakso.
English: Infections.
Slovenian: Okužbe.
English: The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Slovenian: Uspešna presaditev pri vseh bolnikih v preskušanjih druge faze kaže na ustreznost ciljnih vrednosti AUC.
English: DMA is teratogenic in rats.
Slovenian: DMA je teratogen pri podganah.
English: Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
Slovenian: Stopnje hitrega in popolnega prijetja presadka so v večini študij ugotavljali pri 80-100 % bolnikov.
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Slovenian: Približno 30 % uporabljenega odmerka se v 48 urah izloči z urinom, od tega 1 % kot nespremenjen busulfan.
English: It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Slovenian: Možno je, da bo uporaba zdravila Busilvex povečala tveganje za nastanek drugega malignega obolenja v prihodnosti.
English: Small volumes may be administered over 2 hours using electric syringes.
Slovenian: Majhne količine lahko damo v dveh urah z električnimi brizgami.
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Acute GVHD was rated as serious in 3 patients.
Slovenian: Akutna GVHD je bila ocenjena kot resna pri 3 bolnikih.
English: The available data in animals support the carcinogenic potential of busulfan.
Slovenian: Razpoložljivi podatki pri živalih potrjujejo rakotvorni potencial busulfana.
English: Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Slovenian: Reverzibilna vezava na plazemske beljakovine je bila približno 7-odstotna, medtem ko je bila ireverzibilna vezava, predvsem na albumin, približno 32-odstotna.
English: Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Slovenian: Zaznali so tudi povišano vrednost bilirubina (n = 3) in povišano AST (n = 1).
English: Pharmacotherapeutic group: Alkyl sulfonates, ATC code: L01AB01.
Slovenian: Farmakoterapevtska skupina: Alkilsulfonati, Oznaka ATC: L01AB01
English: Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/55).
Slovenian: Infekcije (zabeleženo in nezabeleženo febrilno nevtropenijo) je imelo 89 % bolnikov (49/55).
English: VOD was reported with a range between 3.9% and 15.4%.
Slovenian: VOD so ugotovili pri 3,9 % do 15,4 % bolnikov.
English: Therefore special care is recommended when combining these two compounds.
Slovenian: Zato je pri kombinaciji teh dveh spojin priporočena posebna previdnost.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Slovenian: Bolniki, ki so bili podvrženi predhodni radiacijski terapiji, večji kot ali enaki trem ciklom kemoterapije, ali predhodni transplantaciji progenitorskih celic, so izpostavljeni večjemu tveganju (glejte poglavje 4.8).
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Slovenian: DMA zmanjšuje plodnost pri moških in ženskih glodavcih (glejte poglavji 4.6 in 5.3).
English: Headache Nervous system disorders [Not Elsewhere Classified]
Slovenian: Bolezni živčevja glavobol bolezni živčevja [niso opredeljene drugje]
English: Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Slovenian: Bolniki, starejši od 50 let (n = 23), so bili uspešno zdravljeni z zdravilom Busilvex brez prilagoditve odmerka.
English: However, caution is recommended (see sections 4.8 and 5.2).
Slovenian: Vendar bodite previdni (glejte poglavji 4.8 in 5.2).
English: The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Slovenian: Največja pogostnost navzee in bruhanja je bila 59,1 %, največja pogostnost stomatitisa pa 11 %.
English: Therefore, this interaction should be included in the product information for both pharmaceutical forms.
Slovenian: Zato je treba to medsebojno delovanje dodati med informacije o zdravilu za obe farmacevtski obliki.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Slovenian: O povečani ravni transaminaz tretje stopnje so poročali pri 24 % bolnikov.
English: Same dose (see section 5.2) for elderly patients as for adults (< 50 years old) should be used.
Slovenian: Za starejše priporočamo uporabo enakega odmerka (glejte poglavje 5.2) kot za odrasle (< 50 let).
English: Therefore, “tooth hypoplasia” should be added to the product information for both pharmaceutical forms.
Slovenian: Zato je treba dodati „zobno hipoplazijo” med informacije o zdravilu za obe farmacevtski obliki.
English: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Slovenian: Morate upoštevati ustrezne postopke za ravnanje in odstranjevanje zdravil proti raku.
English: Therefore all patients experienced profound cytopenia: leucopenia 96%, thrombocytopenia 94%, and anemia 88%.
Slovenian: Zato se je pri vseh bolnikih pojavila huda citopenija: levkopenija pri 96 %, trombocitopenija pri 94 % in anemija pri 88 %.
English: The administration of FB regimen has not been specifically investigated in elderly patients.
Slovenian: Uporaba kombinacije FB ni bila posebej preučena pri starejših bolnikih.
English: Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Slovenian: Koncentracije busulfana v cerebrospinalni tekočini lahko primerjamo s tistimi v plazmi, čeprav te koncentracije verjetno niso zadostne za protineoplastični učinek.
English: HVOD occurred in: 8.2% (5/61) allogeneic patients (fatal in 2 patients) and 2.5% (1/42) of autologous patients.
Slovenian: Ta se je pojavila pri: 8,2 % (5/61) alogenskih bolnikov (smrtna pri 2 bolnikih) in 2,5 % (1/42) avtolognih bolnikov.
English: A cumulative review of the literature and safety database has been performed.
Slovenian: Opravil je kumulativni pregled podatkov iz literature in baze podatkov o varnosti zdravila.
English: The benefit risk profile of the product remains favourable in the approved indications.
Slovenian: Razmerje med koristjo in tveganjem zdravila ostaja ugodno za odobrene indikacije.
English: In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Slovenian: Glavni toksični učinki pri človeku so hepatotoksičnost in učinki v centralnem živčnem sistemu (CŽS).
English: The terminal half life ranged from 2.26 to 2.52 h.
Slovenian: Končni razpolovni čas je bil od 2,26 do 2,52 h.
English: As a conclusion, busulfan could be one risk factor of development TMA and a warning is section 4.4 of the Busilvex SmPC is considered warranted.
Slovenian: Zaključimo, da je lahko busulfan eden od dejavnikov tveganja razvoja TMA in opozorilo v poglavju 4.4 SmPC zdravila Busilvex se šteje kot utemeljeno.
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Slovenian: Skupni odmerek busulfana na bolnika je bil med 6,4 mg/kg in 9,6 mg/kg.
English: As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution: - The use of gloves and protective clothing is recommended.
Slovenian: Kot pri vseh citotoksičnih spojinah morate biti pri ravnanju z zdravilom Busilvex in njegovi pripravi previdni: - Priporočena je uporaba rokavic in zaščitnih oblačil.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM 12.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Slovenian: Končna razpolovna doba je bila med 2,8 in 3,9 ure.
English: In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Slovenian: Poleg tega lahko busulfan izzove pljučno toksičnost, ki je lahko aditivna učinkom drugih citotoksičnih učinkovin.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before you receive treatment with Busilvex.
Slovenian: Če ste noseči ali dojite menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete zdravilo Busilvex.
English: Pharmacokinetics in adults
Slovenian: Farmakokinetika pri odraslih
English: if you are currently taking other medicines.
Slovenian: - če ste kdaj imeli epileptične napade, - če trenutno jemljete druga zdravila.
English: The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Slovenian: Pojavnost nalezljivih bolezni ali reaktivacije oportunističnih povzročiteljev nalezljivih bolezni v glavnem odraža imunsko stanje bolnika, ki prejema pripravljalno terapijo.
English: As a result, the control of intravenous busulfan AUC within the therapeutic windows is not modified and a similar targeting performance between the two schedules was illustrated.
Slovenian: Posledično se obvladovanje AUC intravenskega busulfana znotraj terapevtskih oken ne spremeni, zato je dokazana podobna ciljna učinkovitost obeh razporedov.
English: Each infusion will last 2 hours
Slovenian: Vsaka infuzijo bo trajala 2 uri.
English: Pneumonia was fatal in 1% (1/103) and life-threatening in 3% of patients.
Slovenian: Pljučnica je bila smrtna pri 1 % (1/103) in smrtno nevarna pri 3 % bolnikov.
English: In both studies, all patients received a 16/16 dose regimen of Busilvex.
Slovenian: Pri obeh raziskavah so vsi bolniki prejeli terapevtski odmerek 16/16 zdravila Busilvex.
English: HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy.
Slovenian: HPCT je kontraindicirana pri nosečnicah, zato je zdravilo Busilvex med nosečnostjo kontraindicirano.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: PRILOGA IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Elimination in faeces is negligible.
Slovenian: Izločanje z blatom je zanemarljivo.