natgillin/translations-raw huggingface dataset:
Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events. 
Zdravnik bo redno spremljal število krvnih celic in jetrne encime, da bi odkril te težave in primerno ukrepal.
Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW). 
Izračun prilagojene idealne telesne mase (AIBW): AIBW = IBW + 0,25 x (dejanska telesna masa - IBW)
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C) 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 C - 8 C).
Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%. 
Zvišana telesna temperatura se je pojavila pri 87 % bolnikov in je bila ocenjena za blago/zmerno pri 84 % in resno pri 3 %.
The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2hour intravenous infusion for a total of 16 doses over four days. 
Farmakokinetiko intravensko uporabljenega busulfana so preučevali na 124 bolnikih, ki jih je bilo možno oceniti, po 2-urni intravenski infuziji do skupno 16 odmerkov v obdobju 4 dni.
Contribution of long-lasting metabolites is not excluded. 
Prispevek dolgoobstojnih presnovkov ni izključen.
The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications. 
Med najresnejše neželene učinke zdravljenja z zdravilom Busilvex in postopka presaditve sodijo zmanjšanje števila krvnih celic v krvnem obtoku (nameravani učinek zdravila, ki vas pripravi na transplantacijsko infuzijo), okužba, motnje delovanja jeter, vključno z blokiranjem jetrne vene, reakcija presadka proti gostitelju (presadek napade vaše telo) in pljučni zapleti.
For storage conditions after dilution of the medicinal product see section 6.3. 
Za pogoje shranjevanja zdravila po redčenju zdravila glejte poglavje 6.3.
A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients. 
V večini objavljenih študij so ugotavljali popolni donorski himerizem 30. dan po transplantaciji pri 90-100 % bolnikov.
Only a clear solution without particles should be used. 
Uporabiti smete samo bistro raztopino brez delcev.
Women must stop breast-feeding before starting their treatment with Busilvex. 
Ženske morajo prekiniti dojenje pred začetkom zdravljenja z zdravilom Busilvex.
in combination with other medicine as a conditioning treatment previous HCT have been seen after reviewing the literature and the cases retrieved in the safety database of the company. 
v kombinaciji z drugimi pripravljalnimi zdravili pred HCT so opazili po proučitvi literature in primerov iz imetnikove baze podatkov o varnosti zdravila.
Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size. 
Med malformacije in anomalije so sodile pomembne spremembe mišično-skeletnega sistema, pridobivanja telesne mase in velikosti.
Blood: decrease of blood circulating cells (red and white) and platelets. 
Kri: zmanjšanje števila krvnih celic (rdečih in belih) in trombocitov v krvnem obtoku.
• Quantity of Busilvex: 
• Količina zdravila Busilvex:
It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity. 
Priporočamo, da med zdravljenjem teh bolnikov 28 dni po transplantaciji redno pregledujete serumske transaminaze, alkalne fosfataze in bilirubin za zgodnje odkrivanje hepatotoksičnosti.
From a microbiological point of view, the product should be used immediately after dilution. 
Z mikrobiološkega stališča bi morali zdravilo uporabiti takoj po redčenju.
Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells. 
Zdravilo Busilvex je močno citotoksično zdravilo, ki zelo zmanjša število krvnih celic.
The incidence of a-GVHD grades I-II was 46.4% (13/28), while the incidence of grade III-IV was 3.6% (1/28). 
Pogostost a-GVHD stopnje I-II je bila 46,4 % (13/28), medtem ko je bila pojavnost stopnje III-IV 3,6 % (1/28).
The information presented on biotransformation and elimination is based on oral busulfan. 
Podatki o biotransformaciji in izločanju temeljijo na peroralni uporabi busulfana.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended. 
Preostalega zdravila ne smete izpirati v ceveh med uporabo, kajti hitre infuzije zdravila Busilvex še niso preizkusili in je ne priporočamo.
Busilvex may interact with other medicines. 
Zdravilo Busilvex lahko medsebojno učinkuje z drugimi zdravili.
Compared to the four times a day regimen, the once-daily regimen is characterized by a higher peak concentration, no drug accumulation and a wash out period (without circulating busulfan concentration) between consecutive administrations. 
Za dajanje enkrat na dan so v primerjavi z dajanjem štirikrat na dan značilni višji vrh koncentracije, odsotnost kopičenja zdravila in obdobje izpiranja zdravila (brez koncentracij krožečega busulfana) med zaporednimi dajanji.
The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients. 
Posledica zdravljenja z zdravilom Busilvex s priporočenim odmerkom in razporedom je globoka mielosupresija, ki se pojavlja pri vseh bolnikih.
All patients experienced a profound myelosuppression. 
Vsi bolniki so izkusili hudo mielosupresijo.
However, for the safe use of Busilvex in patients older than 60 years only limited information is available. 
Vendar so za varno uporabo zdravila Busilvex pri bolnikih, starejših od 60 let, na voljo le omejeni podatki.
Busulfan belongs to a class of substances which are potentially carcinogenic based on their mechanism of action. 
Busulfan sodi med snovi, ki so zaradi načina delovanja potencialno rakotvorne.
All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan. 
Vsi bolniki morajo predhodno prejeti antikonvulzive, ki preprečijo epileptične napade, o katerih so poročali pri uporabi visokih odmerkov busulfana.
Ask your pharmacist how to throw away medicine you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen. 
Na podlagi podatkov o človeku je Mednarodna agencija za raziskave rakavih obolenj (International Agency for Research on Cancer (IARC)) uvrstila busulfan med človeške karcinogene.
Brain abscess, Inflammation of the skin, generalised infection. 
Možganski absces, vnetje kože, generalizirana okužba.
Busilvex is available in multipacks comprising 2 packs, each containing 4 vials. 
Zdravilo Busilvex je na voljo v skupnih pakiranjih, ki vsebujejo 2 škatli s po 4 vialami.
There are no or limited amount of data from the use of busulfan or DMA in pregnant women. 
Podatkov o uporabi busulfana ali DMA pri nosečnicah ni oziroma so omejeni.
The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight: 
Količino zdravila Busilvex in redčila lahko izračunamo na naslednji način: za bolnika, ki tehta Y kg:
It seems that the recommended intravenous busulfan dose administered either as an individual infusion (3.2 mg/kg) or into 4 divided infusions (0.8 mg/kg) provided equivalent daily plasma exposure with similar both inter-and intrapatient variability. 
Izgleda, da dajanje priporočenega intravenskega odmerka busulfana bodisi kot en odmerek (3,2 mg/kg) bodisi 4 razdeljene infuzije (0,8 mg/kg) privede do enakovredne dnevne izpostavljenosti v plazmi s podobno variabilnostjo med osebami in pri isti osebi.
Documentation on the safety and efficacy of Busilvex in combination with fludarabine (FB) prior to allogeneic HPCT derives from the literature review of 7 published studies involving 731 patients with myeloid and lymphoid malignancies reporting the use of intravenous busulfan infused once daily instead of four doses per day. 
Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s fludarabinom (FB) pred alogensko HPCT izhaja iz pregleda 7 objavljenih študij pri 731 bolnikih z mieloidnimi in limfoidnimi malignimi obolenji, v katerih so uporabili intravenski busulfan, ki je bil infundiran enkrat na dan namesto 4 odmerkov na dan.
Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2) 
Y: telesna masa bolnika v kilogramih D: odmerek zdravila Busilvex (glejte poglavje 4.2)
Busilvex should not be given by rapid intravenous, bolus or peripheral injection. 
Zdravila Busilvex ne smete uporabiti v obliki hitre intravenske injekcije, bolusa ali periferne injekcije.
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole. 
Specifičnega kliničnega preskušanja za oceno o medsebojni interakciji med intravensko uporabljenim busulfanom in itrakonazolom ali metronidazolom niso izvedli.
Doses of 400 mg/kg/day DMA administered during organogenesis caused significant developmental anomalies. 
Med organogenezo so odmerki DMA v višini 400 mg/kg/dan povzročili pomembne anomalije v razvoju.
Precautions to be taken before handling or administering the medicinal product 
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila.
From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance. 
Glede na objavljene raziskave pri odraslih ima lahko uporaba itrakonazola pri bolnikih, ki jemljejo visoke odmerke busulfana, za posledico zmanjšan očistek busulfana.
Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment. 
Ker se busulfan v glavnem presnavlja v jetrih, je priporočljiva posebna previdnost pri uporabi zdravila Busilvex pri bolnikih z že okvarjeno jetrno funkcijo, zlasti pri tistih s hudo okvaro jeter.
- 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C 
- 8 ur (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi 20 °C ± 5 °C,
It must be considered that overdose of Busilvex will also increase exposure to DMA. 
Ne smemo spregledati dejstva, da preveliko odmerjanje zdravila Busilvex povzroči povečano izpostavljenost DMA.
The safety and efficacy of FB in pediatric population has not been established. 
Varnost in učinkovitost zdravljenja s kombinacijo FB pri otrocih še nista bili dokazani.
Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty. 
Zdravilo Busilvex lahko izzove tudi znake menopavze in pri deklicah lahko prepreči začetek pubertete.
For the 40% of children < 9 kg outside the target, the AUC was evenly distributed either below or above the targeted limits; i.e. 20% each < 900 and > 1500 µmol/L.min following 1 mg/kg. 
Pri 40 % otrok z maso < 9 kg, ki niso dosegli ciljnih vrednosti, je bil AUC enakomerno porazdeljen pod ali nad ciljnimi omejitvami, to je 20 % < 900 in 20 % > 1500 µmol/l.minuto po 1 mg/kg.
The solvent dimethylacetamide (DMA) may also impair fertility. 
Topilo dimetilacetamid (DMA) prav tako lahko zmanjšuje plodnost.
This study demonstrated that bodyweight was the predominant covariate to explain the busulfan pharmacokinetic variability in children over body surface area or age. 
Ta študija je pokazala prevladujoč vpliv telesne mase na farmakokinetično variabilnost busulfana pri otrocih v primerjavi s vplivom telesne površine ali starosti.
The literature on busulfan suggests a therapeutic AUC window between 900 and 1500 µmol/L.minute per administration (equivalent to a daily exposure between 3600 and 6000 µmol/L.minute). 
Literatura o busulfanu priporoča terapevtsko območje za AUC med 900 in 1.500 µmol/l.minuto na odmerjanje (enakovredno dnevni izpostavljenosti med 3.600 in 6.000 µmol/l.minuto).
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects. 
Mielosupresija in imunosupresija sta bili želena terapevtska učinka pripravljalnega zdravljenja, zato se nista šteli za neželena učinka.
In view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing busulfan were warranted. 
Na podlagi podatkov iz pregleda PSUR odbor PRAC meni, da so potrebne spremembe informacij o zdravilih, ki vsebujejo busulfan.
Data from a recently completed prospective multicentre phase 2 study including 80 patients, aged 18 to 65 years old, diagnosed with different hematologic malignancies who underwent allo-HCT with an FB (3 days of Busilvex) reduced intensity conditioning regimen became available. 
Na voljo so podatki nedavno zaključene prospektivne multicentrične študije 2. faze pri 80 bolnikih, starih od 18 do 65 let, z različnimi hematološkimi malignimi obolenji po alo-HCT s pripravljalno terapijo z zmanjšano intenzivnostjo kombinacije FB (3 dni prejemanja zdravila Busilvex).
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 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time). 
Kemijsko in fizikalno stabilnost za uporabo po redčenju v 5-odstotni raztopini glukoze ali 0,9-odstotni raztopini natrijevega klorida (9 mg/ml) za injiciranje so dokazali za 8 ur (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi 20 °C ± 5 °C, ali za 12 ur po redčenju, če je bila raztopina shranjena pri temperaturi med 2 °C in 8 °C in nato 3 ure pri temperaturi 20 °C ± 5 °C (vključno s časom infuzije).
Cases of TMA after high doses of busulfan i.v. 
Primere TMA po velikih odmerkih busulfana i.v.
doses in combination with other drugs in conditioning treatment previous HCT could be an important role in the development of TMA. 
odmerki busulfana v kombinaciji z drugimi zdravili pri pripravljalnem zdravljenju pred HCT imeli pomembno vlogo pri razvoju TMA.
In paediatric population, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities. 
Pri pediatrični populaciji, zdravljeni z BuMel, so poročali, da uporaba melfalana manj kot 24 ur po zadnjem peroralnem odmerku busulfana lahko vpliva na nastanek toksičnosti.
There have been two reports that busulfan is dialyzable, thus dialysis should be considered in the case of an overdose. 
V dveh poročilih je omenjeno, da se busulfan dializira, zato je v primeru prevelikega odmerjanja primerno pretehtati možnost dialize.
The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer. 
Svetovna zdravstvena organizacija (World Health Organisation) je ugotovila, da obstaja vzročno razmerje med izpostavljanjem busulfanu in rakom.
Gastro-intestinal: bleeding in the stomach and/or the gut. 
Prebavila: krvavitev v želodcu in/ali črevesu.
The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg. 
Priporočeni odmerek zdravila Busilvex v kombinaciji s ciklofosfamidom ali melfalanom je odvisen od vaše telesne mase in sega od 0,8 do 1,2 mg/kg.
The incidence of a-GVHD grades I-II was 13% (8/61), while the incidence of grade III-IV was 5% (3/61). 
Pojavnost aGVHD stopnje I-II je bila 13-odstotna (8/61), medtem ko je bila pojavnost stopnje III-IV 5-odstotna (3/61).
Not known* 
Neznana pogostnost*
The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion. 
Kombinacija FB je omogočila zadostno mieloablacijo, ki je bila modulirana z intenzivnostjo pripravljalne terapije, in sicer z različnim številom dni infundiranja busulfana.
Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily. 
Podobna ciljna stopnja je dosegljiva z dnevno izpostavljenostjo od 3.600 do 6.000 µmol/l.minuto po intravenski uporabi busulfana v odmerku 3,2 mg/kg enkrat dnevno.
Respiratory: decrease in blood oxygen. 
Dihala: zmanjšanje koncentracije kisika v krvi.
Increase of lactate dehydrogenase in the blood. 
Povečane vrednosti laktat-dehidrogenaze v krvi.
No patients were discontinued from treatment due to adverse reactions related to Busilvex. 
Nihče od bolnikov ni prekinil terapije zaradi neželenih učinkov, povezanih z zdravilom Busilvex.
It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex. 
Antikonvulzive jim je priporočeno dajati od 12 ur pred odmerkom zdravila Busilvex do 24 ur po zadnjem odmerku.
The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7). 
Kaplan-Meierjeva ocena preživetja brez bolezni po 2 letih je bila 49,9 % (95-odstotni IZ 32,6-72,7).
Leukaemia patients treated with busulfan developed many different cytological abnormalities, and some developed carcinomas. 
Pri bolnikih z levkemijo, zdravljenih z busulfanom, se je razvilo mnogo različnih citoloških sprememb, pri nekaterih je nastal karcinom.
Pharmacokinetic/pharmacodynamic relationships: 
Farmakokinetično/farmakodinamično razmerje:
Adverse events information are derived from the clinical study in paediatrics (n=55). 
Informacije o neželenih dogodkih so pridobljene iz pediatrične klinične študije (n = 55).
Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley. 
Busulfan je bil mutagen pri bakteriji Salmonella typhimurium, vinski mušici (Drosophila melanogaster) in ječmenu.
There are no cases with oral busulfan. 
Ni poročil o primerih s peroralnim busulfanom.
The incidence of each adverse reactions presented in the following table has been defined according to the highest incidence observed in published clinical trials in RIC regimen for which the population treated with FB was clearly identified, whatever the schedules of busulfan administrations and endpoints. 
Pojavnost vsakega neželenega učinka v spodnji preglednici je bila opredeljena z največjo pojavnostjo, ugotovljeno v objavljenih kliničnih preskušanjih zdravljenja RIC, v katerih je bila s kombinacijo FB zdravljena populacija natančno opredeljena, ne glede na razporede dajanja busulfana in cilje študij.
You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell. 
To pripravljalno zdravilo boste prejeli pred presaditvijo kostnega mozga ali krvotvornih progenitorskih celic.
The recommended dose and schedule of administration is: - fludarabine administered as a single daily one-hour infusion at 30 mg/m² for 5 consecutive days or 40 mg/m² for 4 consecutive days. 
Priporočeni odmerek in razpored uporabe: - fludarabin se daje kot 1-urna infuzija enkrat na dan v odmerku 30 mg/m², 5 dni zaporedoma, ali v odmerku 40 mg/m², 4 dni zaporedoma.
Very common (may affect more than 1 in 10 people): 
Zelo pogosti neželeni učinki (ki se lahko pojavijo pri več kot 1 od 10 bolnikov):
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time). 
- 12 ur po redčenju, če je bila raztopina shranjena pri temperaturi med 2 °C in 8 °C in nato 3 ure pri temperaturi 20 °C ± 5 °C (vključno s časom infuzije).
DMA decreases fertility in male and female rodents. 
DMA zmanjšuje plodnost samcev in samic glodavcev.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP. 
Zdravila Busilvex ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in na ovojnini poleg oznake EXP.
Menopausal symptoms and female infertility. 
Simptomi menopavze in neplodnosti pri ženskah.
In case of overdose, management would include general supportive care. 
V primeru prevelikega odmerjanja uporabite splošno podporno nego.
A total of 11 patients (18%) experienced a-GVHD. 
Skupno 11 bolnikov (18 %) je izkusilo aGVHD.
The glutathione conjugate is then further metabolised in the liver by oxidation. 
Glutationski konjugat se nato z oksidacijo razgradi v jetrih.
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev) odgovornega (odgovornih) za sproščanje serij
PK/PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis. 
Farmakokinetično/farmakodinamično razmerje so opazili med stomatitisom in vrednostmi AUC pri avtolognih bolnikih, ter med bilirubinom in vrednostmi AUC pri analizi združenih podatkov avtolognih in alogenskih bolnikov.
Intravenous administration of busulfan to mice significantly increased the incidences of thymic and ovarian tumours. 
Intravenska uporaba busulfana pri miših je pomembno povečala pojavnost tumorjev priželjca in jajčnikov.
Women of childbearing potential have to use effective contraception during and up to 6 months after treatment. 
Ženskam v rodni dobi priporočamo, da med zdravljenjem in do 6 mesecev pozneje uporabljajo učinkovito kontracepcijo.
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61). 
Podatki o pojavljanju akutne reakcije presadka proti gostitelju (acute graft-versus-host disease - aGVHD) so bili zbrani v raziskavi OMC-BUS-4 (alogenska) (n = 61).
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients. 
Supresija jajčnikov in amenoreja s simptomi menopavze se pogosto pojavita pri bolnicah, ki so v predmenopavzalnem obdobju.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products. 
Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
IBW women (kg) = 45 + 0.91x (height in cm-152). 
IBW pri moških (kg) = 50 + 0,91 x (višina v cm - 152) IBW pri ženskah (kg) = 45 + 0,91 x (višina v cm - 152)
Documentation on the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/or autologous HPCT derives from two clinical trials (OMC-BUS-4 and OMC-BUS-3). 
Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s ciklofosfamidom v terapiji BuCy2 pred konvencionalno alogensko in/ali avtologno HPCT izhaja iz dveh kliničnih preskušanj (OMC-BUS-4 in OMC-BUS-3).
In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT. 
V tej študiji je prišlo do prijetja presadka pri vseh bolnikih razen enega po 15 dneh (mediana) (razpon 10-23) po alo-HCT.
Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop. 
Razvije se lahko huda granulocitopenija, trombocitopenija, anemija ali katerakoli kombinacija naštetega.
The malformations included serious heart and/or major vessels anomalies: a common truncus arteriosis and no ductus arteriosis, coarctation of the pulmonary trunk and the pulmonary arteries, intraventricular defects of the heart. 
Med malformacije so sodile resne anomalije srca in/ali velikih žil: truncus arteriosus in odsotnost Botallovega voda, koarktacija pljučnega debla in pljučnih arterij, intraventrikularne okvare srca.