FrancophonIA/ELRC3.0 huggingface dataset:
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.
Slovenian: Filgrastim HEXAL 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi: Ena napolnjena injekcijska brizga vsebuje 30 milijonov enot filgrastima v 0,5 ml, kar ustreza 60 M e./ml.
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Slovenian: Filgrastim HEXAL 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi Filgrastim HEXAL 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC Code: L03AA02
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Imunostimulanti, kolonije spodbujajoči faktorji.
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Slovenian: Vzorec krvi za določitev absolutnega števila nevtrofilcev, ko je ta vrednost najnižja, je priporočljivo vzeti tik pred vsakim predvidenim dajanjem filgrastima.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Slovenian: • boleča ali otekla sluznica prebavnega trakta, ki poteka od ust do zadnjika (vnetje sluznice)
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Slovenian: Ugotovili niso nobenih neželenih učinkov, ki bi jih bilo mogoče neposredno pripisati tej stopnji levkocitoze, vendar je treba zaradi možnih tveganj, povezanih s hudo levkocitozo, med zdravljenjem s filgrastimom redno določati število belih krvničk.
English: Hypersensitivity Drug hypersensitivitya Graft versus host diseaseb
Slovenian: Bolezni imunskega sistema preobčutljivost preobčutljivost na zdraviloa reakcija presadka proti gostiteljub anafilaktična reakcija
English: Unless your doctor directs you otherwise, you must stop breast feeding if you use Filgrastim HEXAL.
Slovenian: Če uporabljate zdravilo Filgrastim HEXAL, morate prenehati z dojenjem, razen če vam zdravnik svetuje drugače.
English: Form a skin fold by pinching the skin between thumb and forefinger.
Slovenian: Kožo s palcem in kazalcem stisnite v gubo.
English: Aspartate aminotransferase increased Gammaglutamyl transferase increased
Slovenian: žolčnika in žolčevodov hepatomegalija povečane ravni alkalne fosfataze v krvi povečane ravni aspartat aminotransferaze povečane ravni gama-glutamiltransferaze
English: Glutamic acid Sorbitol (E420) Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi glutaminska kislina sorbitol (E420) polisorbat 80 voda za injekcije
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Slovenian: Ugotovljeno je bilo, da uporaba matičnih celic, izplavljenih v periferno kri s filgrastimom, zmanjša izrazitost in trajanje trombocitopenije po mielosupresivni ali mieloablacijski kemoterapiji.
English: Each pre-filled syringe contains 48 MU (equivalent to 480 μg) filgrastim in 0.5 ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 48 milijonov enot (kar je enako 480 µg) filgrastima v 0,5 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD
Slovenian: ZUNANJI KARTON - NAPOLNJENA INJEKCIJSKA BRIZGA Z ZAŠČITO ZA IGLO
English: PBPC mobilisation e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy c.
Slovenian: zdravljenimi s placebom, ter povezani z posledicami osnovnega malignega obolenja ali citotoksične kemoterapije c.
English: Take special care with other products that stimulate white blood cells.
Slovenian: Bodite posebno pozorni pri uporabi drugih zdravil, ki spodbujajo bele krvne celice Zdravilo Filgrastim HEXAL sodi v skupino zdravil, ki spodbujajo nastanek belih krvnih celic.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Slovenian: Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki so prejemali kronično zdravljenje s filgrastimom, so poročali o zmanjšani kostni gostoti in osteoporozi.
English: Congenital neutropenia
Slovenian: Odmerjanje Prirojena nevtropenija
English: Bronchitis Upper respiratory tract infection Urinary tract infection
Slovenian: Infekcijske in parazitske bolezni sepsa bronhitis okužba zgornjih dihal okužba sečil
English: Solution for injection or infusion in pre-filled syringe.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi.
English: Using the pre-filled syringe with a needle safety guard
Slovenian: Uporaba napolnjene injekcijske brizge z varnostno zaščito za iglo
English: Permanently discontinue Filgrastim HEXAL in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba z uporabo zdravila Filgrastim HEXAL trajno prenehati.
English: Glomerulonephritis Urine abnormality
Slovenian: Bolezni sečil disurija hematurija proteinurija glomerulonefritis nenormalen urin
English: Each pre-filled syringe contains 30 MU (equivalent to 300 μg) filgrastim in 0.5 ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 milijonov enot (kar je enako 300 µg) filgrastima v 0,5 ml.
English: Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Pri odločitvi za uporabo filgrastima pri prenašalcih srpastocelične anemije in bolnikih s srpastocelično anemijo morajo biti zdravniki previdni.
English: Special precautions in normal donors undergoing PBPC mobilisation
Slovenian: Posebni previdnostni ukrepi pri zdravih darovalcih, pri katerih se izvaja izplavljanje matičnih celic v periferno kri
English: Special warnings and precautions across indications
Slovenian: Posebna opozorila in previdnostni ukrepi, povezani s pridruženimi boleznimi
English: Please tell your doctor immediately during treatment with Filgrastim HEXAL, if you: - get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder [these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen].
Slovenian: - začutite bolečino v zgornjem levem delu trebuha (abdominalna bolečina), bolečino pod levim delom prsnega koša ali bolečino na vrhu leve rame [to so lahko simptomi povečane vranice
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU/kg/day (10 μg/kg/day) for 5 - 7 consecutive days.
Slovenian: Če se filgrastim uporablja samostojno, je priporočeni odmerek za izplavljanje matičnih celic v periferno kri 1,0 milijon enot/kg/dan (10 µg/kg/dan) 5 do 7 zaporednih dni.
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Slovenian: Pri rakavih bolnikih, zdravljenih s filgrastimom, so poročali o psevdoprotinu (hondrokalcinozi pirofosfata).
English: • if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Slovenian: - oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Slovenian: • zmanjšana občutljivost, zlasti na koži (hipestezija) • ščemenje ali otopelost rok ali nog (parestezija)
English: Talk to your doctor, pharmacist or nurse before using Filgrastim HEXAL.
Slovenian: Pred začetkom uporabe zdravila Filgrastim HEXAL se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • bone density decreased
Slovenian: • zmanjšanje kostne gostote
English: How to store Filgrastim HEXAL
Slovenian: Shranjevanje zdravila Filgrastim HEXAL
English: HEXAL AG Industriestr.
Slovenian: Imetnik dovoljenja za promet z zdravilom HEXAL AG
English: Aortitis Capillary leak syndromea
Slovenian: Žilne bolezni hipertenzija hipotenzija venookluzivna bolezend aortitis sindrom kapilarne prepustnostia
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive treatments.
Slovenian: Tveganje, povezano z večjimi odmerki mielosupresivnih zdravil Zdravljenje s filgrastimom samim ne prepreči trombocitopenije in anemije, povzročenih z mielosupresivnimi zdravili.
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml - The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Slovenian: Filgrastim HEXAL 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi: Ena napolnjena injekcijska brizga vsebuje 48 milijonov enot filgrastima v 0,5 ml, kar ustreza 96 M e./ml.
English: Pulmonary oedemaa Pulmonary haemorrhage Interstitial lung diseasea Lung infiltrationa Hypoxia
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora hemoptiza dispneja kašelja orofaringealna bolečinaa, e epistaksa akutni sindrom dihalne stiskea dihalna odpoveda pljučni edema pljučna krvavitev intersticijska pljučna bolezena pljučni infiltratia hipoksija
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Slovenian: Po uporabi granulocitne kolonije spodbujajočega faktorja so poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj, in za katerega so značilni hipotenzija,
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: It is recommended that the ANC is measured daily for the first 2 - 3 days of filgrastim administration.
Slovenian: Prva 2 do 3 dni zdravljenja je priporočljivo absolutno število levkocitov določati vsak dan.
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Slovenian: Filgrastim HEXAL 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Slovenian: Za izplavljanje matičnih celic v periferno kri pri zdravih darovalcih pred alogensko presaditvijo v periferno kri izplavljenih matičnih celic
English: • bumpy skin rash (rash macuo-papular)
Slovenian: • kožni izpuščaj v obliki bulic (makulopapularni izpuščaj)
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Slovenian: V kliničnem preskušanju bolnikov s hudo kronično nevtropenijo, ki so dobivali filgrastim, so poročali o mielodisplastičnih sindromih (MDS - Myelodysplastic Syndromes) ali levkemiji, ki pa niso bili pogosti (pri približno 3 %).
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Slovenian: Za izplavljanje krvotvornih matičnih celic v periferno kri pri bolnikih, pri katerih se izvaja mielosupresivno ali mieloablacijsko zdravljenje, ki mu sledi avtologna presaditev matičnih celic izplavljenih v periferno kri
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Slovenian: Izplavljanje matičnih celic v periferno kri zdravim darovalcem ne prinaša neposrednih kliničnih koristi,
English: Neutrophil count
Slovenian: ANC = absolutno število nevtrofilcev (Absolute Neutrophil Count)
English: Paediatric use in the SCN and cancer settings
Slovenian: Pediatrična uporaba pri bolnikih s hudo kronično nevtropenijo in rakavimi obolenji
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Slovenian: Filgrastim HEXAL 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: • nose bleeds (epistaxis)
Slovenian: • krvavitve iz nosu (epistaksa) • zaprtost
English: Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Slovenian: (do 38 dni), odvisno od vrste citotoksične kemoterapije, njenega odmerka in časovnega razporeda.
English: Decreased Appetitee Blood lactate dehydrogenase increased
Slovenian: Presnovne in prehranske motnje zmanjšan apetite povečane ravni laktatdehidrogenaze v krvi hiperurikemija povečane ravni sečne kisline v krvi zmanjšanje ravni glukoze v krvi psevdoprotina
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Slovenian: Pri bolnikih s hudo kronično nevtropenijo, pri katerih se razvije trombocitopenija (število trombocitov < 100 x 109/l), je treba razmisliti o začasnem prenehanju zdravljenja ali o zmanjšanju odmerka filgrastima.
English: Cutaneous vasculitis
Slovenian: Kožni vaskulitis
English: Respiratory, thoracic and mediastinal disorders
Slovenian: hipoalbuminemija, edemi in hemokoncentracija.
English: Special warning and precautions associated with co-morbidities Special precautions in sickle cell trait and sickle cell disease Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Med uporabo filgrastima pri prenašalcih srpastocelične anemije in bolnikih s srpastocelično anemijo so poročali o srpastoceličnih krizah, ki so se v nekaterih primerih končale s smrtjo.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Preizkusi kemotaktične in fagocitne funkcije so pokazali, da delujejo nevtrofilci, ki nastanejo kot odziv na zdravljenje s filgrastimom,
English: Transformation to leukaemia or myelodysplastic syndrome
Slovenian: preobrazba v mielodisplastični sindrom ali levkemijo pri bolnikih s hudo kronično nevtropenijo,
English: 0.5 MU/kg/day (5 μg/kg/day) from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Slovenian: Dajati ga je treba od prvega dne po zaključeni kemoterapiji in dokler ne preide obdobje pričakovanega najmanjšega števila nevtrofilcev ter se njihovo število normalizira.
English: Proteinuria
Slovenian: Dojenje
English: The following information is intended for healthcare professionals only
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Raztopino je treba pred uporabo vizualno pregledati.
English: Leukocytosisa
Slovenian: Trombocitopenija
English: Chronic GvHD TRM
Slovenian: Sandoz GmbH
English: Always keeping your skin pinched, depress the plunger slowly and evenly.
Slovenian: Napolnjena injekcijska brizga brez varnostne zaščite za iglo Med tem, ko kožo še naprej držite med palcem in kazalcem, bat počasi in enakomerno potisnite.
English: Pre-filled syringe with needle safety guard
Slovenian: 1 napolnjena injekcijska brizga z varnostno zaščito za iglo
English: b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain,
Slovenian: c Vključujejo bolečine v kosteh, bolečine v hrbtu, artralgijo, mialgijo, bolečine v okončinah, mišičnoskeletne bolečine, mišično-skeletne bolečine v prsnem košu, bolečine v vratu d Primere so opazili v obdobju trženja pri bolnikih, pri katerih je bila opravljena presaditev kostnega mozga ali je potekalo izplavljanje PBPC
English: Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Slovenian: ker ni bilo dokazano, da bi se stanje kar zadeva tumor izboljšalo, povečevanje odmerka kemoterapevtikov pa ima lahko za posledico povečanje škodljivih učinkov, vključno z učinki na srce,
English: Blood glucose decreased Pseudogouta (Chondrocalcinosis Pyrophosphate) Fluid volume disturbances
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegalijaa zmanjšanje ravni hemoglobinae levkocitozaa raztrganje vranicea srpastoce lična anemija s krizo
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*.
Slovenian: En mililiter raztopine vsebuje 96 milijonov enot (M e.) (kar je enako 960 mikrogramom [µg]) filgrastima*.
English: Diarrhoeaa, e Vomitinga, e Nauseaa
Slovenian: Bolezni prebavil driskaa, e bruhanjea, e navzeaa oralna bolečina zaprtoste
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Slovenian: Pri bolnikih, ki so dobivali filgrastim, so poročali o trombocitopeniji.
English: Transfusion reactione a See section c (Description of selected adverse reactions)
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih reakcija na transfuzijoe a Glejte razdelek c (Opis izbranih neželenih učinkov) b Obstajajo poročila o GvHD in smrtnih primerih bolnikov po alogenski presaditvi kostnega mozga
English: Filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Slovenian: Filgrastim je treba razredčiti v 20 ml 5 % raztopine glukoze
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voncento on 12 August 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Voncento, veljavno po vsej Evropski uniji, izdala 12. avgusta 2013.
English: What measures are being taken to ensure the safe and effective use of Voncento?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Voncento?
English: Other information about Voncento
Slovenian: Druge informacije o zdravilu Voncento
English: The full EPAR for Voncento can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Voncento je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Its side effects were generally mild to moderate and were considered typical for this type of medicine.
Slovenian: Njegovi neželeni učinki so bili na splošno blagi do zmerni ter značilni za tovrstna zdravila.
English: This is a summary of the European public assessment report (EPAR) for Voncento.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Voncento.
English: This causes problems with blood clotting, leading to bleeding in the joints, muscles or internal organs.
Slovenian: Posledica tega so težave s strjevanjem krvi, kar povzroča krvavitve v sklepih, mišicah ali notranjih organih.
English: The Agency decided that Voncento's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Voncento večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Voncento was not compared with another treatment.
Slovenian: Zdravila Voncento niso primerjali z nobenim drugim zdravljenjem.
English: Patients or their carers may be able to inject or infuse the medicine themselves at home if their doctor considers it appropriate and once they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko po opravljenem usposabljanju zdravilo injicirajo ali infundirajo doma sami, če zdravnik meni, da je to primerno.
English: Voncento's effects were rated excellent in around 92% (371 out of 405) of the bleeding episodes and good in around 7% (27 out of 405) of episodes.
Slovenian: Učinki zdravila Voncento so bili ocenjeni kot odlični pri približno 92 % (371 od 405) epizod krvavitev in kot dobri pri približno 7 % (27 od 405) epizod.
English: The dose and duration of treatment also depend on the patient's factor VIII levels, the severity of the disease, the extent and location of the bleeding and the patient's condition and bodyweight.
Slovenian: Odmerek in trajanje zdravljenja sta prav tako odvisna od bolnikovih ravni faktorja VIII, resnosti bolezni, obsega in mesta krvavitve, stanja bolnika ter njegove telesne mase.
English: It is not intended to provide practical advice on how to use Voncento.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Voncento have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Voncento izkazalo v študijah?
English: Among the 37 surgeries that occurred during the study, of which 12 were major, the blood loss was more than expected in only one case.
Slovenian: Med 37 kirurškimi posegi, od katerih je bilo 12 večjih, je pri samo enem prišlo do večje izgube krvi od pričakovane.
English: What are the risks associated with Voncento?
Slovenian: Kakšna tveganja so povezana z zdravilom Voncento?
English: The most common side effect of Voncento is headache (affecting more than 1 in 10 people).
Slovenian: Najpogostejši neželeni učinek zdravila Voncento je glavobol (ki prizadene več kot 1 bolnika od 10).
English: This part of the study showed that the average number of bleeding events in patients on preventive treatment was reduced from between 18 and 82 events during the year before the preventive treatment to between 1 and 6 events.
Slovenian: Ta del študije je pokazal, da se je povprečno število krvavitev pri bolnikih na preventivnem zdravljenju zmanjšalo z vrednosti od 18 do 82 krvavitev na leto pred preventivnim zdravljenjem na vrednosti od 1 do 6 krvavitev po njem.
English: In this study, when used to treat bleeding, Voncento was rated excellent in 60% (396 out of 656) of the bleeding events and good in 36% (236 out of 656) of the bleeding events.
Slovenian: V tej študiji je bilo zdravilo Voncento, kadar so ga uporabili za zdravljenje krvavitev, ocenjeno kot odlično pri 60 % (396 od 656) epizod krvavitev in kot dobro pri 36 % (236 od 656) epizod krvavitev.
English: Why is Voncento approved?
Slovenian: Zakaj je bilo zdravilo Voncento odobreno?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Voncento have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Voncento upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.