natgillin/translations-raw huggingface dataset:
In new-born infants, children and adolescents (0 to 17 years):
Pri novorojenčkih, otrocih in mladostnikih (od 0 do 17 let):
Therefore careful monitoring will be performed.
Zaradi tega boste pod skrbnim nadzorom.
At the recommended dose, this is the desired effect.
Ob priporočenih odmerkih je to želeni učinek.
Contact your doctor immediately if you get any of the following symptoms.
Takoj povejte zdravniku, če se vam pojavi kateri od naslednjih simptomov.
Incomplete development of teeth
Nepopoln razvoj zobovja.
Vials 2 years.
2 leti
Each infusion will last 2 hours
- Vsaka infuzija bo trajala 2 uri.
Not known (frequency cannot be estimated from the available data) Sex glands dysfunction
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Disfunkcija spolnih žlez.
No dose adjustment was deemed necessary.
Prilagoditev odmerka ni bila potrebna.
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).
Pogostnost pojavljanja je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Patients should receive adequate anticonvulsant prophylaxis.
Bolnikom je potrebno zagotoviti primerno antikonvulzivno profilakso.
The administration of FB regimen has not been specifically investigated in elderly patients.
Uporaba sheme FB ni posebej raziskana pri starejših bolnikih.
Paediatric population (0 to 17 years) The safety and efficacy of FB in pediatric population has not been established.
Pediatrična populacija (0-17 let) Varnost in učinkovitost sheme FB pri pediatrični populaciji nista ugotovljeni.
However, caution is recommended (see sections 4.8 and 5.2).
Vseeno je potrebna previdnost (glejte poglavji 4.8 in 5.2).
The following information is intended for healthcare professionals only PREPARATION GUIDE
Naslednje informacije so namenjene samo zdravstvenemu osebju:
*veno occlusive liver disease is more frequent in paediatric population.
* veno-okluzivna jetrna bolezen je pogostejša pri pediatrični populaciji
Hypogonadism**
Hipogonadizem**
Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Bolniki, starejši od 50 let (n = 23), so bili uspešno zdravljeni z busulfanom brez prilagoditve odmerka.
39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
39 % bolnikov (40/103) je izkusilo eno ali več epizod infekcij, od katerih jih je bilo 83 % (33/40) ocenjenih za blago ali zmerno.
If you are concerned about having children, you should discuss this with your doctor before treatment.
Če vas skrbi, da ne boste mogli imeti otrok, se pred začetkom zdravljenja o tem posvetujte z zdravnikom.
60 mg per vial
60 mg v vsaki viali
Each vial contains 10 ml of concentrate.
Vsaka viala vsebuje 10 ml koncentrata.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in na škatli poleg oznake EXP.
Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
O kronični GVHD so poročali le, če je bila vzrok smrti: 1 bolnik je umrl 13 mesecev po transplantaciji.
Grade 3 elevated transaminases were reported in 24% of patients.
O povišani ravni transaminaz 3 stopnje so poročali pri 24 % bolnikov.
Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Reverzibilna vezava na plazemske beljakovine je bila približno 7 %, medtem ko je bila ireverzibilna vezava, predvsem na albumin, približno 32 %.
HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy.
HPCT je kontraindicirana pri nosečnicah, zato je busulfan kontraindiciran med nosečnostjo.
Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Približno 30 % uporabljenega odmerka se v 48 urah izloči z urinom, od tega 1 % v obliki nespremenjenega busulfana.
The terminal half-life ranged from 2.8 to 3.9 hours.
Končni razpolovni čas je bil med 2,8 in 3,9 ure.
Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Celotni odmerek busulfana na bolnika je bil med 6,4 mg/kg in 9,6 mg/kg.
Each vial is sleeved with shrinkable plastic film.
Vsaka vijala je ovita s skrčljivim plastičnim filmom.
Actual body weight (kg)
Dejanska telesna masa (kg)
Ask your pharmacist how to throw away medicine you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Večina objav je poročala o popolnem donorskem himerizmu na dan + 30 pri od 90 do 100 % bolnikov.
From a microbiological point of view, the product should be used immediately after dilution.
Z mikrobiološkega stališča je potrebno zdravilo uporabiti takoj po redčenju.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Datum prve odobritve: 22.07.2014 Datum zadnjega podaljšanja:
Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Koncentracije busulfana v cerebrospinalni tekočini lahko primerjamo s tistimi v plazmi, čeprav te koncentracije verjetno niso zadostne za antineoplastični učinek.
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 Busulfan Fresenius Kabi.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete zdravilo Busulfan Fresenius Kabi.
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).
Bolniki, ki so bili podvrženi predhodni radiacijski terapiji, večji ali enaki trem ciklom kemoterapije, ali predhodni transplantaciji progenitorskih celic, so izpostavljeni večjemu tveganju (glejte poglavje 4.8).
Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Obravnavali so jo kot smrt, ki bi jo bilo mogoče pripisati sekundarnim neželenim učinkom po HPCT in nepovezano z recidivom/napredovanjem osnovne maligne hematološke bolezni.
Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Pozni hemoragični cistitis, ki se pojavi 2 tedna po transplantaciji, je verjetno povezan z virusno okužbo/reaktivacijo virusa.
Paediatric population (0 to 17 years) The recommended dose of busulfan is as follows:
Pediatrična populacija (0-17 let) Priporočeni odmerki busulfana so:
In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Glavni toksični učinki pri človeku so hepatotoksičnost in učinki na centralni živčni sistem (CŽS).
Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
O hemoragičnem cistitisu, vključno s hemoragičnim cistitisom povzročenim z virusno okužbo, so poročali pri 16 do 18,1 %.
The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Pojav okužb ali reaktivacije oportunističnih okužb je v glavnem odsev imunskega stanja bolnikov, ki prejemajo pripravljalno shemo.
RECOMMENDATION FOR SAFE HANDLING Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Upoštevati morate ustrezne postopke za ravnanje in odstranjevanje zdravil proti raku.
The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Primarni parametri učinkovitosti v teh raziskavah so bili mieloablacija, prijetje presadka, ponovljivost in preživetje.
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.
Zato se nadzor AUC intravenskega busulfana znotraj terapevtskega okna ni spremenil, prikazana pa je bila podobna ciljna zmogljivost obeh razporedov.
In both studies, all patients received a 16/16 dose regimen of busulfan.
Pri obeh raziskavah so vsi bolniki prejeli terapevtski odmerek 16/16 busulfana.
In adults
Odrasli
DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
DMA zmanjšuje plodnost pri samcih in samicah glodavcev (glejte poglavji 4.6 in 5.3).
- If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
- Če koncentrat ali razredčena raztopina busulfana pride v stik s kožo ali sluznico, ju je takoj potrebno temeljito sprati z vodo.
Nevertheless the risk of liver toxicity may be increased in this population.
Vendar pa pri tej skupini bolnikov obstaja povečano tveganje toksičnosti za jetra.
Investigations: elevated liver enzymes and weight increased.
Preiskave: povišane vrednosti jetrnih encimov in povečanje telesne teže.
However, for the safe use of busulfan in patients older than 60 years only limited information is available.
Vendar so za varno uporabo busulfana pri bolnikih, starejših od 60 let, na voljo le omejeni podatki.
The review of the literature allows a comparison of PK series performed either within the same study or between studies and demonstrated unchanged dose-independent PK parameters regardless the dosage or the schedule of administration.
Pregled literature omogoča primerjavo farmakokinetičnih zaporedij, opravljenih bodisi znotraj ene študije, bodisi med študijami, in je pokazal nespremenjene, od odmerka neodvisne, farmakokinetične parametre, ne glede na odmerjanje ali razpored uporabe.
Busulfan is for single use only.
Busulfan je samo za enkratno uporabo.
It is possible that use of Busulfan Fresenius Kabi may increase the risk of suffering another malignancy in the future.
Obstaja možnost, da bo uporaba zdravila Busulfan Fresenius Kabi povečala tveganje za nastanek drugega malignega obolenja v prihodnosti.
CNS changes precede any of the more severe side effects.
Spremembe v CŽS nastopijo pred katerim koli hudim neželenim učinkom.
A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and non-malignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Populacijska farmakokinetična analiza je bila izvedena pri skupini 205 otrok , z ustrezno zastopanostjo glede na telesno maso (3,6-62,5 kg) ter glede na biološke in bolezenske značilnosti (maligne in benigne bolezni) in je zato reprezentativna za visoko heterogenost otrok, podvrženih HPTC.
For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Pri debelih bolnikih je treba razmisliti o odmerku, ki temelji na prilagojeni idealni telesni masi (AIBWAdjusted Ideal Body Weight).
Using a non polycarbonate syringe fitted with a needle:
- Z ne-polikarbonatno brizgo, na kateri je nameščena igla:
Other medicines and Busulfan Fresenius Kabi Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Druga zdravila in zdravilo Busulfan Fresenius Kabi 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.
In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin.
V tej študiji je 24 odraslih bolnikov prejelo klonazepam (0,025-0,03 mg/kg/dan z neprekinjeno intravensko infunzijo) kot antikonvulzivno terapijo; farmakokinetične podatke teh bolnikov so primerjali s predhodno zbranimi podatki bolnikov, ki so prejemali fenitoin.
Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, alkyl sulfonates, ATC code: L01AB01.
Farmakoterapevtska skupina: antineoplastična zdravila, alkilirajoča zdravila, alkilsulfonati, oznaka ATC: L01AB01
The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Kumulativna incidenca okrevanja nevtrofilcev na 28. dan je bila 98,8 % (95 % IZ: od 85,7 do 99,9 %).
Dose and administration The dose of busulfan will be calculated according to your body weight.
Odmerek in uporaba: Odmerek busulfana vam bodo preračunali glede na vašo telesno maso.
Pack size 1 pack containing 8 vials (8 cartons of 1 vial).
Pakiranje 1 pakiranje, ki vsebuje 8 vial (8 škatel z eno vialo).
The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion.
Kombinacija s FB je omogočila zadostno mieloablacijo, modulirano z intenzivnostjo pripravljalne sheme s spreminjanjem števila dni infundiranja busulfana.
As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to busulfan.
Kot je dokumentirano v kliničnih raziskavah, se pri nobenem zdravljenem bolniku ni pojavila srčna tamponada ali katera koli druga značilna srčna toksičnost, povezana z busulfanom.
Precautions to be taken before handling or administering the medicinal product This medicinal product must be diluted prior to administration.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila To zdravilo je potrebno pred uporabo razredčiti.
Busulfan in combination with fludarabine (FB)
Busulfan v kombinaciji s fludarabinom (FB)
The consequence of treatment with busulfan at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Posledica zdravljenja z busulfanom v priporočenem odmerku in razporedu je globoka mielosupresija, ki se pojavlja pri vseh bolnikih.
Adverse reactions information is derived from two clinical trials (n=103) of busulfan.
Informacije o neželenih učinkih so pridobljene iz dveh kliničnih preskušanj (n = 103) busulfana.
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, izven ciljnega območja, je bil AUC enakomerno porazdeljen pod ali nad ciljnimi omejitvami, to je 20 % < 900 in 20 % > 1500 µmol/l·min po odmerku 1 mg/kg.
Small volumes may be administered over 2 hours using electric syringes.
Majhne količine lahko damo v dveh urah s črpalko na brizgo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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 še do 6 mesecev po zdravljenju uporabljajo učinkovito kontracepcijo.
The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Glavna toksična učinka sta huda mieloablacija in pancitopenija, vendar so lahko prizadeti tudi centralni živčni sistem, jetra, pljuča in prebavni trakt.
Busulfan Fresenius Kabi is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Zdravilo Busulfan Fresenius Kabi se uporablja pri odraslih, novorojenčkih, pri otrocih in mladostnikih kot terapija pred presaditvijo.
The most frequent infectious adverse reactions were Cytomegalovirus (CMV) reactivation [range: 30.7% - 80.0%], Epstein-Barr Virus (EBV) reactivation [range: 2.3% - 61%], bacterial infections [range: 32.0% - 38.9%] and viral infections [range: 1.3% - 17.2%].
Najpogostejši infekcijski neželeni učinki so bili reaktivacija citomegalovirusa (CMV) [razpon: 30,780,0 %], reaktivacija virusa Epstein-Barr (EBV) [razpon: 2,3-61 %], bakterijske okužbe [razpon: 32,038,9 %] in virusne okužbe [razpon: 1,3-17,2 %].
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, pridobivanje na telesni masi in velikosti.
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 se med zdravljenjem teh bolnikov 28 dni po transplantaciji redno kontrolira serumske transaminaze, alkalno fosfatazo in bilirubin, za zgodnje odkrivanje hepatotoksičnosti.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of busulfan has not been tested and is not recommended.
Preostalega zdravila ne smete izpirati v ceveh med uporabo, saj hitre infuzije busulfana še niso preizkusili in ni priporočena.
It must be considered that overdose of busulfan will also increase exposure to DMA.
Preveliko odmerjanje busulfana povzroči tudi povečano izpostavljenost DMA.
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)
In the absence of haematopoietic progenitor cell transplantation, the recommended dose of busulfan would constitute an overdose of busulfan.
V odsotnosti transplantacije hematopoetskih progenitorskih celic bi priporočeni odmerek busulfana povzročil prevelik odmerek busulfana.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Vsi postopki prenašanja zdravila zahtevajo strogo upoštevanje aseptičnih postopkov, po možnosti uporabo komore z vertikalnim laminarnim pretokom zraka.
Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin's disease or non-Hodgkin's lymphoma, and myelodysplastic syndrome.
Vključene bolezni so bile: akutna levkemija po prvi remisiji, v prvi ali naslednji ponovitvi, v prvi remisiji (veliko tveganje) ali napake v indukciji, kronična mieloidna levkemija v kronični ali napredovali fazi, primarna refraktarna ali rezistentna ponovljena Hodgkinsova bolezen ali neHodgkinsov limfom ter mielodisplastični sindrom.
Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Busulfan je povzročil kromosomske aberacije in vitro (pri celicah glodavcev in pri človeških celicah) ter in vivo (pri glodavcih in človeku).
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 učinke in primerno ukrepal.
Particular caution should be taken if you use itraconazol and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Bodite posebej previdni, če jemljete itrakonazol in metronidazol (za zdravljenje določenih vrst okužb) ali ketobemidon (za lajšanje bolečin).
In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Pri podganah je 9-dnevno odmerjanje DMA v odmerku 450 mg/kg/dan povzročilo neaktivno spermatogenezo.
Chronic GVHD (c-GVHD) was reported if serious or the cause of death, and was reported as the cause of death in 3 patients.
O kronični GVHD (cGVHD) so poročali, če je bila resna ali vzrok smrti; poročali so, da je bila vzrok smrti pri 3 bolnikih.
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.
Če raztopine ne uporabite takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika in običajno ne smejo presegati zgoraj omenjenih pogojev, če je redčenje opravljeno v kontroliranih in validiranih aseptičnih pogojih.
Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Neželeni učinki iz raziskav v obdobju trženja zdravila so v preglednicah prikazani z incidenco "neznana pogostnost".
These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Te vključujejo infekcijo in reakcijo presadka proti gostitelju (graft-versus-host disease (GVHD)), ki sta glavna vzroka za obolelost in smrtnost, zlasti v primeru alogenske HPCT, čeprav nista neposredno povezana.
10 ml of concentrate for solution for infusion in clear colourless glass vials (type I) with teflon faced rubber stopper and sealed with aluminium flip-off seal.
10 ml koncentrata za raztopino za infundiranje v prozornih, brezbarvnih steklenih vialah (steklo tipa I) s teflonsko prevlečenim gumijastim zamaškom in zapečatenih z aluminijsko snemno (flip-off) zaporko.
Busulfan dose (mg/kg)
Odmerek busulfana (mg/kg)
If not used immediately, in-use storage times and conditions 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.
Če raztopine ne uporabite takoj, so čas in pogoji shranjevanja med uporabo odgovornost uporabnika in običajno ne smejo presegati zgoraj omenjenih pogojev, če je redčenje opravljeno v kontroliranih in validiranih aseptičnih pogojih.
Studies in animals have shown reproductive toxicity (embryo-foetal lethality and malformations) (see section 5.3)
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja (embriofetalna smrtnost in malformacije) (glejte poglavje 5.3).
Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Pri bolnikih z okvaro ledvic raziskave niso bile izvedene, ker pa se busulfan zmerno izloča z urinom, pri teh bolnikih odmerka ni priporočljivo spreminjati.
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Neželeni učinki, o katerih so poročali pri več kot enem primeru, so po organskih sistemih in po pogostnosti razvrščeni spodaj.
No patients were discontinued from treatment due to adverse reactions related to busulfan.
Nihče od bolnikov ni prekinil terapije zaradi neželenih učinkov, povezanih z busulfanom.
8 MARKETING AUTHORISATION NUMBER(S) EU/1/14/951/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/951/001