FrancophonIA/ELRC3.0 huggingface dataset:
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Slovenian: Pri 15 % (4/27) bolnikov z avtologno in 7 % (2/28) bolnikov z alogensko transplantacijo so poročali o veno-okluzivni bolezni (VOD).
English: The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis.
Slovenian: Analiza podatkov z metodo populacijske farmakokinetike je pokazala, da ni razlik v očistku intravensko uporabljenega busulfana pri zdravljenju, ki temelji na fenotoinu ali klonazepamu, torej so pri obeh vrstah preprečevanja epileptičnih napadov bile dosežene podobne izpostavitve busulfanu v plazmi.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Slovenian: Resne toksičnosti, ki vključujejo hematološki, jetrni in respiratorni sistem, so smatrali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
English: On the basis of the scientific conclusions for busulfan the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing busulfan is unchanged subject to the proposed changes to the product information
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za busulfan odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) busulfan, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: During clinical trials with intravenous busulfan administered as 0.80 mg/kg four-times daily, 90% of patients AUCs were below the upper AUC limit (1500 µmol/L.minute) and at least 80% were within the targeted therapeutic window (900-1500 µmol/L.minute).
Slovenian: Med kliničnimi preskušanji z intravensko uporabo busulfana v odmerku 0,80 mg/kg štirikrat dnevno je bilo 90 % bolnikov pod zgornjo mejo površine pod krivuljo (1.500 µmol/l.minuto) in vsaj 80 % bolnikov je bilo znotraj ciljnega terapevtskega območja (900-1.500 µmol/.minuto).
English: The recommended dose of Busilvex is as follows: Actual body weight (kg)
Slovenian: Priporočeni odmerki zdravila Busilvex so: Dejanska telesna masa (kg)
English: Nervous system: insomnia, anxiety, dizziness, and depression.
Slovenian: Živčni sistem: nespečnost, tesnoba, omotica in depresija.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use (IV)
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba (i.v.)
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Slovenian: Vsi postopki prenašanja zahtevajo strogo upoštevanje aseptičnih pogojev, po možnosti uporabo laminarija.
English: The safety profile of Busilvex combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Slovenian: Varnostni profil zdravila Busilvex v kombinaciji s fludarabinom (FB) je bil pripravljen s pregledom neželenih učinkov v objavljenih podatkih kliničnih preskušanj zdravljenja RIC.
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Slovenian: Skupni plazemski očistek je bil med 2,25 in 2,74 ml/minuto/kg.
English: The signals concerning busulfan oral formulations and hepatic veno-oclusive disease risk in patients who have received prior radiation therapy /chemotherapy /HSCT, sterility, overdose treatment can be closed.
Slovenian: Zapremo lahko tudi signale v zvezi s peroralnimi oblikami busulfana in tveganjem hepatične veno-okluzivne bolezni pri bolnikih, ki so predhodno prejeli zdravljenje z obsevanjem/kemoterapijo/HSCT, signal v povezavi s sterilnostjo, ukrepanjem ob prekomernem odmerku.
English: Busulfan is mutagenic and clastogenic.
Slovenian: Busulfan je mutagen in klastogen.
English: The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9 kg in achieving the therapeutic window (900-1500 µmol/L.minute).
Slovenian: Priporočeno odmerjanje zdravila pri otrocih je podrobno navedeno v poglavju 4.2 in omogoča da 70 % do 90 % otrok s telesno maso ≥9 kg doseže terapevtsko okno (900-1500 µmol/l.minuto).
English: Busilvex must always be added to the diluent, not the diluent to Busilvex.
Slovenian: Busilvex morate vedno dodajati v redčilo, in ne redčila v Busilvex.
English: 10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
Slovenian: 10 ml koncentrata za raztopino za infundiranje v prozornih steklenih vialah (tipa I) z zamaškom iz butilne gume in vijolično aluminijasto snemno (flip-off) zaporko.
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Slovenian: Anemija (hemoglobin < 8,0 g/dl) se je pojavila pri 69 % bolnikov.
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (ki se lahko pojavijo pri največ 1 od 100):
English: Patients received doses of 0.8 mg/kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/kg once per day for two days (BuCy2 regimen).
Slovenian: Bolniki so prejemali odmerke po 0,8 mg/kg busulfana vsakih 6 ur z infuzijo do skupno 16 odmerkov, ki so jim sledili odmerki 60 mg/kg ciklofosfamida enkrat dnevno dva dneva (terapija BuCy2).
English: Serious toxicities involving the hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Slovenian: Resne toksičnosti, ki vključujejo jetrni in respiratorni sistem, so smatrali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
Slovenian: • Količina redčila: (A ml zdravila Busilvex) x (10) = B ml redčila
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Slovenian: Zdravilo Busilvex boste prejeli enkrat na dan, 2 ali 3 zaporedne dni pred presaditvijo.
English: One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Slovenian: En ml koncentrata vsebuje 6 mg busulfana (60 mg v 10 ml).
English: if you have a liver, kidney, heart or lung problem,
Slovenian: Morate povedati zdravniku: - če imate težave z jetri, srcem ali pljuči,
English: In paediatric population, absolute neutrophil counts < 0.5x109/l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Slovenian: Pri pediatrični populaciji se je absolutno število nevtrofilcev < 0,5x109/l pri mediani 3 dni po transplantaciji pojavilo pri 100 % bolnikov in je trajalo 5 dni pri avtologni ter 18,5 dneva pri alogenski transplantaciji.
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex due to a possible decrease in the metabolism of busulfan (See section 4.5).
Slovenian: Pri predhodni (manj kot 72 ur) ali sočasni uporabi paracetamola z zdravilom Busilvex morate biti previdni zaradi možne upočasnjene presnove busulfana (glejte poglavje 4.5).
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Slovenian: Anemija (hemoglobin < 8,0 g/dl) se je pojavila pri 100 % bolnikov.
English: There was no regimen-related death through the first 100-day post-transplant and up to one year post-transplant.
Slovenian: V prvih 100 dneh po transplantaciji in do enega leta po transplantaciji ni bilo niti enega primera smrti, povezanega z zdravljenjem.
English: Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Slovenian: Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s ciklofosfamidom v terapiji BuCy4 ali melfalanom v terapiji BuMel pred konvencionalnim alogensko in/ali avtologno HPCT izhaja iz kliničnega preskušanja F60002 IN 101 G0.
English: Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Slovenian: Srce: spremembe in nepravilnosti srčnega utripa, zadrževanje tekočine ali vnetje okoli srca, zmanjšan izhodni volumen srca.
English: The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Slovenian: Infuzija celotnega predpisanega odmerka zdravila Busilvex mora trajati dve ali tri ure, odvisno od pripravljalne terapije.
English: - the calculated volume of Busilvex must be removed from the vial.
Slovenian: - izračunano prostornino zdravila Busilvex morate odstraniti iz viale.
English: In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Slovenian: Pri novorojencih, otrocih in mladostnikih se zdravilo Busilvex uporablja v kombinaciji s ciklofosfamidom ali melfalanom.
English: In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.
Slovenian: V vodnem mediju sproščanje metansulfonatnih skupin povzroči nastanek ogljikovih ionov, ki lahko alkilirajo DNA.
English: Busilvex destroys the original bone marrow before the transplant.
Slovenian: Zdravilo Busilvex uniči izvorni kostni mozeg bolnika pred presaditvijo.
English: Irreversible protein binding may explain the incomplete recovery.
Slovenian: Vzrok za nepopoln izkoristek je lahko ireverzibilna vezava na beljakovine.
English: Occurrence of VOD was not related to overexposure.
Slovenian: Pogostost veno-okluzivne bolezni ni bila povezana s preveliko izpostavljenostjo.
English: Chronic GVHD (c-GVHD) was reported if serious or the cause of death, and was reported as the cause of death in 3 patients.
Slovenian: O kronični GVHD (cGVHD) so poročali, če je bila resna ali vzrok smrti.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/(m²) > 30 kg/m² until further data become available.
Slovenian: Dokler ne bodo na voljo dodatni podatki, uporaba zdravila pri debelih otrocih in mladostnikih z indeksom BMI (masa (kg)/višina (m2)) nad 30 kg/m2 ni priporočljiva.
English: LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
Slovenian: SEZNAM POMOŽNIH SNOVI Vsaka viala vsebuje dimetilacetamid in makrogol 400.
English: Muscle and bone: back, muscle and joint pain.
Slovenian: Mišice in kosti: bolečine v hrbtu, mišicah in sklepih.
English: In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Slovenian: V objavljenih študijah pri uporabi zdravljenja FB pri odraslih niso ugotovili medsebojnega delovanja med intravenskim busulfanom in fludarabinom.
English: No specific antidote for DMA overdose is known.
Slovenian: Pri prevelikem odmerjanju DMA ni znanega antidota.
English: - Busilvex will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
Slovenian: - Zdravilo Busilvex se daje v odmerku 3,2 mg/kg kot 3-urna infuzija enkrat na dan nemudoma po fludarabinu, 2 ali 3 dni zaporedoma.
English: Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Slovenian: Uporabo zdravila Busilvex mora nadzorovati zdravnik, izkušen v pripravljalnih terapijah pred transplantacijo hematopoetskih progenitorskih celic.
English: Busulfan can impair fertility.
Slovenian: Busulfan lahko zmanjša plodnost.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for busulfan, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za busulfan je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.
Slovenian: Poročali so, da lahko pri odraslih bolnikih, ki se zdravijo z BuCy2, časovni interval med zadnjim peroralnim odmerkom busulfana in prvim odmerkom ciklofosfamida vpliva na razvoj toksičnosti.
English: Busilvex should be administered by intravenous infusion via central venous catheter.
Slovenian: Zdravilo Busilvex morate intravensko infundirati skozi osrednji venski kateter.
English: Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Slovenian: Srce: zamašitev femoralne arterije, dodatni utripi srca, zmanjšanje hitrosti srčnega utripa, difuzno prepuščanje tekočine iz kapilar (majhnih krvnih žil).
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Slovenian: Pri otrocih s telesno maso < 9 kg je bila opažena večja variabilnost, ki je , da je 60 % otrok doseglo terapevtsko okno (900-1500 µmol/l·min).
English: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Slovenian: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex Francija
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for:
Slovenian: Kemijsko in fizikalno stabilnost med uporabo, po redčenju v 5-odstotni raztopini glukoze ali 0,9odstotni raztopini natrijevega klorida (9 mg/ml) za injiciranje so dokazali za:
English: Renal: increase in creatinine elimination, discomfort in urination, decrease in urine output and bloody urine.
Slovenian: Ledvica: povečanje kreatininskega očistka, bolečine pri uriniranju, zmanjšanje količine urina in kri v urinu.
English: Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Slovenian: Mielosupresija in imunosupresija sta zaželena terapevtska učinka pripravljalne terapije.
English: The pharmacokinetics of Busilvex has been investigated.
Slovenian: Raziskovali so farmakokinetiko zdravila Busilvex.
English: However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Slovenian: Vendar je bilo v objavljenih študijah pripravljalna terapija s FB uporabljena pri več kot 500 bolnikih, starih ≥55 let.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Slovenian: Hematološki status mora biti pod strogim nadzorom, in če je klinično nakazano, je treba poseči po učinkovitih podpornih ukrepih.
English: Concentrate 4 vials of 10ml.
Slovenian: Škatla s 4 vialami po 10 ml
English: Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Slovenian: Zdravilo Busilvex je v obliki bistre, brezbarvne raztopine v prozornih steklenih vialah (tipa I) s prostornino 10 ml.
English: Mainly studies from literature have shown that high busulfan i.v.
Slovenian: Predvsem po ugotovitvah iz literature bi lahko veliki i.v.
English: was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Slovenian: Po 2 letih je bila kumulativna pojavnost NRM 11,3 % (95-odstotni IZ 5,5-19,3 %), stopnja ponovitve ali napredovanja po alo-HCT pa 43,8 % (95-odstotni IZ 31,1-55,7 %).
English: Skin: Skin colour disorder, redness of the skin, skin desquamation.
Slovenian: Koža: motnje obarvanosti kože, rdečica kože, luščenje kože.
English: Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Slovenian: Dajanje zdravila Busilvex po fludarabinu (FB) je indicirano kot pripravljalna terapija pred transplantacijo hematopoetskih progenitorskih celic (HPCT) pri odraslih bolnikih, ki so kandidati za zdravljenje z zmanjšano intenzivnostjo (RIC).
English: Busulfan is thought to be leukemogenic.
Slovenian: Busulfan se obravnava kot levkemogen.
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Slovenian: Infekcijske in parazitske bolezni virusna okužba reaktivacija CMV reaktivacija EBV bakterijska okužba invazivna glivna okužba okužba pljuč možganski absces celulitis sepsa
English: The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
Slovenian: Bodite zelo previdni pri uporabi paracetamola 72 ur pred uporabo ali sočasno z uporabo zdravila Busilvex.
English: Obese patients In adults
Slovenian: Debeli bolniki Odrasli
English: Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Slovenian: Zdravilo Busilvex boste prejeli vsakih 6 ur, 4 zaporedne dni pred presaditvijo.
English: A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics.
Slovenian: Za oceno vpliva zdravljenja za preprečevanje epilepsije na farmakokinetiko intravensko uporabljenega busulfana so izvedli klinično preskušanje 2. faze.
English: Do not use Busilvex: if you are allergic to busulfan or any of the other ingredients of Busilvex listed in section 6, if you are pregnant, or think you may be pregnant.
Slovenian: Ne uporabljajte zdravila Busilvex: - če ste alergični na busulfan ali katero koli drugo sestavino zdravila Busilvex, navedeno v poglavju
English: Calculation of the quantity of Busilvex to be diluted and of the diluent
Slovenian: Izračun količine zdravila Busilvex, ki ga morate razredčiti, in redčila
English: Busilvex must not be infused concomitantly with another intravenous solution.
Slovenian: Zdravila Busilvex ne uporabljajte sočasno z drugo intravensko raztopino.
English: Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Slovenian: Med preostale pogoste anomalije sodi volčje žrelo, ansarka in anomalije vretenc in reber.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
English: Multipack containing 8 (2 packs of 4) vials.
Slovenian: Skupno pakiranje vsebuje 8 vial (v 2 škatlah po 4).
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Slovenian: Čas, potreben, da je skupno število nevtrofilcev (Absolute Neutrophil Count - ANC) preseglo 0,5 x 109/l, je bil pri alogenskih bolnikih 21 dni (interval 12-47 dni), pri avtolognih bolnikih pa 11 dni (interval 10-15 dni).
English: Immediate and complete availability of the dose is obtained after intravenous infusion of busulfan.
Slovenian: Po intravenski infuziji busulfana so dosegli takojšnjo in popolno razpoložljivost odmerka.
English: In adults, absolute neutrophil counts < 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
Slovenian: Pri odraslih se je absolutno število nevtrofilcev < 0,5 x 109/l pri mediano 4 dneh po transplantaciji pojavilo pri 100 % bolnikov in se je popravilo pri mediano 10 dneh po avtologni oziroma 13 dneh po alogenski transplantaciji (mediano trajanje nevtropenije je znašalo 6 oziroma 9 dni).
English: Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
Slovenian: V drugi klinični fazi sta bili na bolnikih s hematološkimi obolenji, pri večini katerih je bolezen že napredovala, opravljeni dve enokraki, odprti, nekontrolirani raziskavi možnosti zdravljenja.
English: Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Slovenian: Posebna previdnost pri uporabi priporočenega odmerka zdravila Busilvex je potrebna pri bolnikih z anamnezo epileptičnih napadov.
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Slovenian: Med zdravljenjem ter do končne ozdravitve je potrebno pogosto pregledovati popolno krvno sliko, vključno z diferencialno sliko belih krvnih celic in trombocitov.
English: Overall mortality and non- relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Slovenian: Pri alogenskih bolnikih je bila celokupna smrtnost pri več kot 100 dnevih po transplantaciji 13-odstotna (8/61), smrtnost, ki ni bila povezana s ponovitvijo bolezni, pa 10-odstotna (6/61).
English: In adults Busilvex is used in combination with cyclophosphamide or fludarabine.
Slovenian: Pri odraslih se zdravilo Busilvex uporablja v kombinaciji s ciklofosfamidom ali fludarabinom.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Slovenian: Za preprečevanje in nadzorovanje okužb v nevtropeničnem obdobju je treba pretehtati možnost preventivne ali empirične uporabe zdravil proti okužbam (bakterijskim, glivičnim in virusnim).
English: Component of a multipack, cannot be sold separately.
Slovenian: Koncentrat 4 viale po 10 ml. Del skupnega pakiranja, ne smejo se prodajati ločeno.
English: followed by: - 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or - one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of Busilvex.
Slovenian: Temu sledijo: - 4 cikli po 50 mg/kg telesne mase (TM) ciklofosfamida (BuCy4) ali - en odmerek 140 mg/m2 melfalana (BuMel),
English: Delirium Nervousness Hallucination Agitation
Slovenian: Psihiatrične motnje vznemirjenost zmedenost halucinacije
English: Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (embriofetalno smrtnost in malformacije) (glejte poglavje 5.3).
English: Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Slovenian: Zato morate biti pri bolnikih z anamnezo obsevanja pljuč ali medpljučnega prostora na ta pojav pozorni (glejte poglavje 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX {Box containing 8 vials of 10ml}
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Z MODRIM OKENCEM Škatla z 8 vialami po 10 ml
English: • The diluted solution must be mixed thoroughly by inverting several times.
Slovenian: • Vrečko morate temeljito premešati z nekajkratnim obračanjem .
English: Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Slovenian: Dihala: povečanje frekvence dihanja, dihalna odpoved, alveolarne krvavitve, astma, ohlapnost majhnih delov pljuč, nabiranje tekočine okrog pljuč.