FrancophonIA/ELRC3.0 huggingface dataset:
English: Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended.
Croatian: Ne preporučuje se preuranjeni prekid terapije filgrastimom, tj. prije očekivanog smanjenja broja neutrofila na najnižu vrijednost.
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/496/001
Croatian: Filgrastim HEXAL 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki EU/1/08/496/001
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Croatian: Pedijatrijski bolesnici s teškom kroničnom neutropenijom Slučajevi smanjene gustoće kostiju i osteoporoze zabilježeni su u pedijatrijskih bolesnika s teškom kroničnom neutropenijom koji primaju kronično liječenje filgrastimom.
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/l.
Croatian: Može biti potrebna dugotrajna primjena da bi se apsolutni broj neutrofila održao na > 2,0 x 109/l.
English: During intermittent dosing with 30 MU/day (300 μg/day) of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Croatian: 30 MU/dan (300 μg/dan) u bolesnika mogu tijekom vremena postojati velike fluktuacije apsolutnog broja neutrofila.
English: Each pre-filled syringe contains 30 million units (equivalent to 300 micrograms) filgrastim in 0.5 ml (60 MU/ml).
Croatian: Jedna napunjena štrcaljka sadrži 30 milijuna jedinica (što odgovara 300 mikrograma) filgrastima u 0,5 ml (60 MU/ml).
English: • enlargement of the liver (hepatomegaly)
Croatian: • bol u području usta • povećanje jetre (hepatomegalija)
English: Splenic rupturea Sickle cell anaemia with crisis
Croatian: Ruptura slezenea Anemija srpastih stanica s krizom
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.
Croatian: Jedna napunjena štrcaljka sadrži 48 MU filgrastima u 0,5 ml, što odgovara 96 MU/ml - Pomoćne tvari su glutamatna kiselina, sorbitol (E420), polisorbat 80 i voda za injekcije.
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/496/005
Croatian: Filgrastim HEXAL 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki EU/1/08/496/005
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Croatian: Pseudogiht (hondrokalcinoza pirofosfat) je prijavljen u bolesnika s malignom bolešću koji primaju filgrastim.
English: musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or
Croatian: mišićno-koštanu bol u prsištu, bol u vratu d Nakon stavljanja lijeka u promet zabilježeni su slučajevi u bolesnika s transplantiranom koštanom srži ili mobilizacijom progenitorskih stanica iz periferne krvi (PBPC)
English: The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Croatian: Prva doza filgrastima ne smije se primijeniti prije nego što protekne barem 24 sata nakon citotoksične kemoterapije.
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU/kg/day (10 μg/kg/day) for 4 - 5 consecutive days.
Croatian: Za mobilizaciju progenitorskih stanica iz periferne krvi u zdravih davatelja, filgrastim treba primjenjivati u dozi od 1,0 MU/kg/dan (10 μg/kg/dan) tijekom 4 - 5 uzastopnih dana.
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Croatian: U zdravih davatelja primijećene su prolazne citogenetske abnormalnosti nakon primjene G-CSF.
English: Solution for injection or infusion in pre-filled syringe (injection or infusion).
Croatian: Otopina za injekciju ili infuziju u napunjenoj štrcaljki (injekcija ili infuzija) Bistra, bezbojna do svijetložuta otopina.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim HEXAL.
Croatian: Slučajno izlaganje niskim temperaturama neće štetno utjecati na stabilnost lijeka Filgrastim HEXAL.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE / PRE-FILLED SYRINGE WITH A NEEDLES SAFETY GUARD
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA / NAPUNJENA ŠTRCALJKA SA SIGURNOSNOM ZAŠTITOM ZA IGLU
English: The recommended starting dose is 0.5 MU/kg/day (5 μg/kg/day) as a single dose or in divided doses.
Croatian: Preporučena početna doza je 0,5 MU/kg/dan (5 μg/kg/dan) u obliku jedne ili više doza.
English: Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Croatian: No, posebna ispitivanja nisu provedena za tu skupinu pa se stoga ne mogu dati posebne preporuke za doziranje.
English: Complete blood cell counts with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Croatian: Prije liječenja potrebno je napraviti kompletnu krvnu sliku s diferencijalnom krvnom slikom i brojem trombocita, kao i procjenu morfologije koštane srži i kariotipa.
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Croatian: Vrućica nije trajala kraće u bolesnika koji su primali mijeloablativnu terapiju prije presađivanja koštane srži.
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.
Croatian: Filgrastim HEXAL 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki: Jedna napunjena štrcaljka sadrži 30 MU filgrastima u 0,5 ml, što odgovara 60 MU/ml.
English: However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Croatian: terapija filgrastimom ne smije se prekinuti prije nego što se broj neutrofila nakon očekivanog smanjenja na najniže vrijednosti ne oporavi do normalnog raspona vrijednosti.
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Croatian: Filgrastim HEXAL 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki Jedan ml otopine sadrži 60 milijuna jedinica (MU) (što odgovara 600 mikrograma [μg]) filgrastima*.
English: Filgrastim HEXAL works by encouraging the bone marrow to produce more white blood cells.
Croatian: HEXAL djeluje poticanjem koštane srži da proizvodi više bijelih krvnih stanica.
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
Croatian: U kliničkim ispitivanjima te u razdoblju nakon stavljanja lijeka u promet prijavljeni su plućne nuspojave, uključujući intersticijsku bolest pluća, plućni edem i plućnu infiltraciju, u nekim slučajevima s ishodom respiratornog zatajenja ili sindroma akutnog respiratornog distresa (ARDS),
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.
Croatian: Preporučena doza filgrastima za mobilizaciju progenitorskih stanica iz periferne krvi kod samostalne primjene iznosi 1,0 MU/kg/dan (10 μg/kg/dan) tijekom 5 - 7 uzastopnih dana.
English: Each pre-filled syringe contains 48 MU (equivalent to 480 μg) filgrastim in 0.5 ml.
Croatian: Jedna napunjena štrcaljka sadrži 48 MU (što odgovara 480 μg) filgrastima u 0,5 ml.
English: Each pre-filled syringe contains 30 MU (equivalent to 300 μg) filgrastim in 0.5 ml.
Croatian: Jedna napunjena štrcaljka sadrži 30 MU (što odgovara 300 μg) filgrastima u 0,5 ml.
English: Dose adjustment
Croatian: Prilagodbe doze:
English: Bronchitis Upper respiratory tract infection Urinary tract infection
Croatian: Bronhitis Infekcija gornjih dišnih putova
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers (e.g. C-reactive protein and white blood cell count) were raised.
Croatian: U zdravih osoba i bolesnika oboljelih od raka nakon primjene G-CSF-a zabilježen je aortitis, čiji su simptomi uključivali vrućicu, bol u abdomenu, malaksalost, bol u leđima i povišene upalne markere (npr. C-reaktivni protein i broj leukocita).
English: • generally feeling unwell (malaise)
Croatian: • opća slabost (astenija) • opće loše osjećanje (malaksalost)
English: Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Croatian: Nije utvrđena sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Croatian: Taj rizik može biti povećan u bolesnika koji su nedavno imali plućne infiltrate ili pneumoniju.
English: Bone density decreased Exacerbation of rheumatoid arthritis
Croatian: Mišićni spazmi Osteoporoza Smanjenje gustoće kostiju Pogoršanje reumatoidnog artritisa
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
Croatian: Filgrastim HEXAL 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki Filgrastim HEXAL 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Croatian: Posebne mjere opreza u bolesnika s teškom kroničnom neutropenijom Filgrastim se ne smije primjenjivati u bolesnika s teškom kongenitalnom neutropenijom kod kojih se razvila leukemija ili s dokazanim razvojem leukemije.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Croatian: Posebne mjere opreza u primatelja alogenih progenitorskih stanica iz periferne krvi mobiliziranih filgrastimom
English: Form a skin fold by pinching the skin between thumb and forefinger.
Croatian: Uhvatite kožu palcem i kažiprstom kako biste oblikovali nabor kože.
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Croatian: Nakon primjene G-CSF zabilježene su plućne nuspojave, osobito intersticijska bolest pluća.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Croatian: Posebne mjere opreza u bolesnika s malignom bolešću Filgrastim se ne smije koristiti za povećanje doze citotoksične kemoterapije iznad utvrđenih shema doze.
English: Please tell your doctor before starting treatment if you have: - osteoporosis (bone disease); - sickle cell anaemia, as Filgrastim HEXAL may cause sickle cell crisis.
Croatian: - osteoporozu (bolest kostiju); - anemiju srpastih stanica jer Filgrastim HEXAL može uzrokovati krizu srpastih stanica.
English: - Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Croatian: infekcijom kako bi se smanjio rizik od bakterijske infekcije kad druge opcije za liječenje neutropenije nisu prikladne.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Croatian: Testovi kemotaktičke i fagocitne funkcije pokazali su da neutrofili proizvedeni u odgovoru na filgrastim imaju normalnu ili pojačanu funkciju.
English: Do not administer Filgrastim HEXAL to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Croatian: bolesnicima s anamnezom preosjetljivosti na filgrastim ili pegfilgrastim.
English: If leukocyte counts exceed 50 x 109/l after the expected nadir, filgrastim should be discontinued immediately.
Croatian: 50 x 109/l, primjenu filgrastima treba odmah prekinuti.
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Croatian: Pokazalo se da primjena progenitorskih stanica iz periferne krvi mobiliziranih filgrastimom smanjuje jačinu i trajanje trombocitopenije nakon mijelosupresivne ili mijeloablativne kemoterapije.
English: Maculopapular rash
Croatian: Makulopapularni osip
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Croatian: Sigurnosni profili u pedijatrijskih bolesnika liječenih zbog teške kronične neutropenije nisu se razlikovali.
English: Pre-filled syringe without needle safety guard
Croatian: Napunjena štrcaljka bez sigurnosne zaštite za iglu
English: Long-term daily administration is required to maintain an adequate neutrophil count.
Croatian: potrebna je dugotrajna svakodnevna primjena.
English: Musculoskeletal painc
Croatian: Mišićno-koštana bolc
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.
Croatian: oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, otežano disanje, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: Veno-occlusive diseased
Croatian: Venookluzivna bolestd
English: • rejection of transplanted bone marrow (graft versus host disease)
Croatian: • alergijska reakcija (preosjetljivost) • odbacivanje transplantirane koštane srži (reakcija presatka protiv primatelja )
English: Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Croatian: Doze filgrastima treba nastaviti svakodnevno primjenjivati sve dok se broj neutrofila nakon očekivanog smanjenja na najnižu vrijednost ne oporavi do normalnog raspona vrijednosti.
English: The long-term safety of filgrastim administration above 24 μg/kg/day in patients with SCN has not been established.
Croatian: U bolesnika s teškom kroničnom neutropenijom nije utvrđena sigurnost dugotrajne primjene filgrastima u dozi većoj od 24 μg/kg/dan.
English: Dizziness Hypoaesthesia Paraesthesia
Croatian: Hemoptiza Dispneja Kašalja
English: Using the pre-filled syringe with a needle safety guard
Croatian: Uporaba napunjene štrcaljke sa sigurnosnom zaštitom za iglu
English: - have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Croatian: - osjetite bol u gornjoj lijevoj strani trbuha (abdomena), bol na lijevoj strani ispod rebara ili u vrhu lijevog ramena [to mogu biti simptomi povećanja slezene (splenomegalije) ili mogućeg puknuća (rupture) slezene]. - primijetite neuobičajeno krvarenje ili nastanak modrica [to mogu biti simptomi smanjenja broja krvnih pločica (trombocitopenije) sa smanjenom sposobnošću zgrušavanja krvi]. - imate iznenadne znakove alergije poput osipa, svrbeža ili koprivnjače, oticanja lica, usana, jezika ili drugih dijelova tijela, nedostatka zraka, zviždanje ili poteškoće pri disanju jer to mogu biti znakovi teške alergijske reakcije (preosjetljivost).
English: Insert the needle into the skin fold with a quick, firm action.
Croatian: Brzim, odlučnim potezom uvedite iglu u nabor kože.
English: 30 MU/day (300 μg/day) is recommended.
Croatian: Preporučuje se prilagoditi početnu dozu na 30 MU/dan (300 μg/dan) za primjenu svaki drugi dan.
English: Glomerulonephritis has been reported in patients receiving filgrastim or pegfilgrastim.
Croatian: U bolesnika koji primaju filgrastim ili pegfilgrastim zabilježen je glomerulonefritis.
English: • are pregnant or breast-feeding;
Croatian: • ste trudni ili dojite;
English: • changes in blood chemistry
Croatian: • promjene rezultata krvnih pretraga • reakcija na transfuziju
English: Hypersensitivity
Croatian: Preosjetljivost Preosjetljivost na lijeka
English: Anaphylactic reaction
Croatian: Anafilak tička reakcija
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Croatian: zaštićeni naziv primijenjenog lijeka treba jasno navesti u medicinskoj dokumentaciji bolesnika.
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.
Croatian: Posebna upozorenja i mjere opreza povezani s komorbiditetima Posebne mjere opreza kod nasljednog obilježja srpastih stanica i bolesti srpastih stanica
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.
Croatian: Preporučena doza filgrastima za mobilizaciju progenitorskih stanica iz periferne krvi nakon mijelosupresivne kemoterapije iznosi 0,5 MU/kg/dan (5 μg/kg/dan) i daje se od prvog dana nakon završetka kemoterapije pa sve dok se broj neutrofila nakon očekivanog smanjenja na najnižu vrijednost ne oporavi do normalnog raspona vrijednosti.
English: Filgrastim HEXAL 30 MU/0.5 ml injection or infusion Filgrastim
Croatian: Filgrastim HEXAL 30 MU/0,5 ml injekcija ili infuzija filgrastim s.c./i.v.
English: Filgrastim HEXAL 48 MU/0.5 ml injection or infusion Filgrastim
Croatian: Filgrastim HEXAL 48 MU/0,5 ml injekcija ili infuzija filgrastim s.c./i.v.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Croatian: Kod bolesnika liječenih filgrastimom prijavljeni su slučajevi Sweetova sindroma (akutne febrilne neutrofilne dermatoze).
English: In view of the possible risk of microbial contamination, Filgrastim HEXAL syringes are for single use only.
Croatian: štrcaljke Filgrastim HEXAL namijenjene su samo za jednokratnu uporabu.
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Croatian: • osip s kvržicama na koži (makulopapularni osip)
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Croatian: Filgrastim HEXAL 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Croatian: Filgrastim HEXAL 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: Aortitis Capillary leak syndromea
Croatian: Aortitis Sindrom povećane propusnosti kapilaraa
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Croatian: Primjena filgrastima za mobilizaciju progenitorskih stanica iz periferne krvi u zdravih davatelja prije alogene transplantacije progenitorskih stanica iz periferne krvi
English: Special precautions in normal donors undergoing PBPC mobilisation
Croatian: Posebne mjere opreza u zdravih davatelja koji se podvrgavaju mobilizaciji progenitorskih stanica iz periferne krvi
English: Other special populations
Croatian: Druge posebne populacije Primjena u starijih bolesnika
English: Cutaneous vasculitis has been reported in patients treated with filgrastim.
Croatian: U bolesnika liječenih filgrastimom prijavljen je kožni vaskulitis.
English: Haemoptysis Dyspnoea Cougha Oropharyngeal paina, e
Croatian: Orofaringealna bola, e
English: Oral pain Constipatione
Croatian: Tablični sažetak nuspojava
English: Diarrhoeaa, e Vomitinga, e Nauseaa
Croatian: Povraćanjea, e Mučninaa
English: Pre-filled syringe with needle safety guard
Croatian: Napunjena štrcaljka sa sigurnosnom zaštitom za iglu
English: Dysuria Haematuria
Croatian: Plućne nuspojave
English: Pulmonary adverse effects
Croatian: Trombocitopenija Anemijae
English: - notice unusual bleeding or bruising [these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot].
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • smanjenje broja trombocita što smanjuje sposobnost zgrušavanja krvi (trombocitopenija)
English: Meta-Analysis
Croatian: Metaanaliza
English: Special precautions in patients undergoing PBPC mobilisation
Croatian: Posebne mjere opreza u bolesnika koji se podvrgavaju mobilizaciji progenitorskih stanica iz periferne krvi
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,
Croatian: Uključuje koštanu bol, bol u leđima, artralgiju, mijalgiju, bol u ekstremitetima, mišićno-koštanu bol,
English: Paediatric use in the SCN and cancer settings
Croatian: Pedijatrijska uporaba s teškom kroničnom neutropenijom i malignom bolešću
English: GvHD
Croatian: • proljev
English: Geriatric use
Croatian: FARMAKOLOŠKA SVOJSTVA
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.
Croatian: Cjeloviti EPAR za lijek Voncento nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 10-2017.
Croatian: Sažetak je posljednji put ažuriran u 10. 2017.
English: This causes problems with blood clotting, leading to bleeding in the joints, muscles or internal organs.
Croatian: To uzrokuje probleme pri zgrušavanju krvi, što dovodi do krvarenja u zglobovima, mišićima ili unutarnjim organima.
English: Other information about Voncento
Croatian: Ostale informacije o lijeku Voncento
English: Voncento was not compared with another treatment.
Croatian: Voncento nije uspoređen s drugim terapijama.
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.
Croatian: Bolesnici ili njihovi njegovatelji mogu sami injektirati ili infundirati lijek kod kuće ako to njihov liječnik smatra primjerenim, te nakon što su završili odgovarajuću obuku.
English: Other common side effects (affecting up to 1 in 10 people) include hypersensitivity (allergic) reactions and fever.
Croatian: Druge uobičajene nuspojave (koje se javljaju u 1 na 10 osoba) uključuju reakcije hipersenzitivnosti (alergije) i vrućicu.
English: Its side effects were generally mild to moderate and were considered typical for this type of medicine.
Croatian: Njegove nuspojave općenito su bile blage do umjerene te se smatraju tipičnima za ovu vrstu lijeka.
English: This is a summary of the European public assessment report (EPAR) for Voncento.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Voncento.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voncento on 12 August 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Voncento na snazi u Europskoj uniji od 12. kolovoza 2013.