FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, dosing with 30 MU (300 µg )/day on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week.
Slovenian: V kliničnih študijah so morali za vzdrževanje absolutnega števila nevtrofilcev na ravni > 2,0 x 109/L uporabljati 30 M e. (300 µg)dan v obdobju od enega do sedmih dni na teden; mediana pogostnosti dajanja je znašala 3 dni na teden.
English: In normal donors, dyspnoea has been reported commonly and other pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, and hypoxia) have been reported uncommonly.
Slovenian: Pri zdravih dajalcih so pogosto poročali o dispneji in občasno o drugih pljučnih neželenih dogodkih (hemoptiza, krvavitev v pljučih, pljučni infiltrati, in hipoksija).
English: Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 96 milijonov enot (M e.) (kar ustreza 960 mikrogramom [μg]) filgrastima.
English: Gammaglutamyl transferase increased Aspartate aminotransfera se increased
Slovenian: Neznana pogostno st hepatomegal ija povečane ravni aspartat aminotransfe raze
English: Dose reductions of Filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Slovenian: Pri bolnikih s hudo kronično nevtropenijo je zmanjšanje odmerka filgrastima upočasnilo ali ustavilo povečevanje vranice, pri 3 % bolnikov pa je bila potrebna splenektomija.
English: Pulmonary adverse effects
Slovenian: Neželeni učinki na pljučih
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Slovenian: Občasno so pri bolnikih, zdravljenih z visokimi odmerki kemoterapije, ki ji je sledila presaditev, poročali o žilnih boleznih, vključno z vensko-okluzivno boleznijo in motnjami ravnovesja tekočin.
English: What Accofil is
Slovenian: Kaj je zdravilo Accofil
English: Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further.
Slovenian: k. Med tem ko kožo še naprej držite med palcem in kazalcem, bat počasi in enakomerno potisnite ter držite prirobnico, dokler ni vbrizgan celoten odmerek, bata pa ni mogoče potisniti še naprej.
English: EU/1/14/946/005 - 1 prefilled syringe with a needle safety guard EU/1/14/946/008 - 5 prefilled syringes with a needle safety guard EU/1/14/946/007 - 3 prefilled syringe with a needle safety guard EU/1/14/946/010 - 10 prefilled syringe with a needle safety guard EU/1/14/946/017 - 7 prefilled syringe with a needle safety guard
Slovenian: EU/1/14/946/005 − 1 napolnjena injekcijska brizga z varnostno zaščito za iglo EU/1/14/946/008 − 5 napolnjenih injekcijskih brizg z varnostno zaščito za iglo EU/1/14/946/007 − 3 napolnjene injekcijske brizge z varnostno zaščito za iglo EU/1/14/946/010 − 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo EU/1/14/946/017 − 7 napolnjenih injekcijskih brizg z varnostno zaščito za iglo
English: Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim.
Slovenian: Po dajanju filgrastima so zelo pogosto poročali o primerih splenomegalije in pogosto o primerih raztrganja vranice.
English: Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 ml, corresponding to 0.6 mg/ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 M e./0,5 ml (300 mikrogramov) filgrastima v 0,5 ml, kar ustreza 0,6 mg/ml.
English: Check the expiry date on the pre-filled syringe label (EXP).
Slovenian: b. Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjene injekcijske brizge
English: Name and address of the manufacturer(s) of the biological active substance(s) Intas Pharmaceuticals Ltd.
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
English: What Accofil contains
Slovenian: Kaj vsebuje zdravilo Accofil
English: Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it. Do not put the cover back on used needles, as you may accidentally prick yourself.
Slovenian: Ne uporabljajte zdravila Accofil, če opazite, da je raztopina motna, obarvana ali so v njej delci.
English: Pulmonary haemorrhage Hypoxia
Slovenian: Bolezni živčevja glavobola omotica hipestezija parestezija
English: Leukocytosis (WBC > 50 x 109/L) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim treatment and leukapheresis was observed in 35% of donors.
Slovenian: Po zdravljenju s filgrastimom so levkocitozo (število belih krvnih celic > 50 x 109/L) opazili pri 41% dajalcev, opazili pa so tudi prehodno trombocitopenijo (število trombocitov < 100 x 109/L) in levkaferezo so opazili pri 35% dajalcev.
English: Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 ml, corresponding to 0.96 mg/ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 48 M e./0,5 ml (480 mikrogramov) filgrastima v 0,5 ml, kar ustreza 0,96 mg/ml.
English: Uncommon side effects (seen in more than 1 in 1000 people taking Accofil):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri več kot 1 od 1000 oseb, ki uporabljajo zdravilo Accofil):
English: Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Slovenian: NAVODILO ZA UPORABO Accofil 48 M e./0,5 ml (0,96 mg/ml) raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Hypersensitivity is common in patients with cancer;
Slovenian: Preobčutljivost se pri rakavih bolnikih pojavlja pogosto.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Slovenian: d. Da bo injiciranje manj neprijetno, pustite napolnjeno injekcijsko brizgo stati 30 minut zunaj hladilnika.
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Slovenian: Pri bolnikih s hudo kronično nevtropenijo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton - Pre-filled syringe with a needle safety guard in blister pack
Slovenian: Zunanja ovojnina − Napolnjena injekcijska brizga z varnostno zaščito za iglo
English: Using the pre-filled syringe with a needle safety guard
Slovenian: Uporaba napolnjene brizge z varnostno zaščito za iglo
English: The first dose of Accofil should not be administered less than 24 hours following cytotoxic chemotherapy.
Slovenian: Bolnik lahko prvi odmerek zdravila Accofil prejme šele 24 ur po citotoksični kemoterapiji.
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.
Slovenian: Varnost in učinkovitost filgrastima pri bolnikih z mielodisplastičnim sindromom ali kronično mielogeno levkemijo nista bili dokazani.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Slovenian: Pri pediatričnih bolnikih, ki so se zdravili zaradi hude kronične nevtropenije, ni prišlo do razlik v varnostnih profilih.
English: Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
Slovenian: Pri zdravih dajalcih in bolnikih so po uporabi G-CSF poročali o pogostih, a v splošnem asimptomatskih primerih splenomegalije, v občasnih primerih pa o raztrganju vranice.
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Slovenian: Zdravnik vas bo morda skrbno spremljal.
English: Very common side effects (seen in more than 1 in 10 people who take Accofil):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb, ki uporabljajo zdravilo Accofil):
English: • if you get left upper belly (abdonimal) pain, pain below the left rib cage or pain at the tip of your shoulder since this may relate to a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen)..
Slovenian: • če začutite bolečino v levem zgornjem delu trebuha (abdomna), bolečino pod levim delom prsnega koša ali v zgornjem predelu ramen, saj lahko te bolečine nakazujejo težave z vranico (povečanje vranice (splenomegalija) ali raztrganje vranice).
English: Accofil 30 MU/0.5 ml (0.6 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Slovenian: NAVODILO ZA UPORABO Accofil 30 M e./0,5 ml (0,6 mg/ml) raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Ahmedabad - 382213 Gujarat
Slovenian: Intas Pharmaceuticals Ltd. Plot no: 423/ P/A Sarkhej Bavla Highway Village Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, Indija
English: Filgrastim for PBPC mobilisation when used alone:
Slovenian: Če se filgrastim uporablja za izplavljanje PBPC samostojno
English: How Accofil is given
Slovenian: Kako se daje zdravilo Accofil
English: Paediatric patients in the SCN and cancer settings
Slovenian: Posebni previdnostni ukrepi pri bolnikih z rakom Splenomegalija in raztrganje vranice
English: Special precautions in sickle cell trait and sickle cell disease
Slovenian: Posebni previdnostni ukrepi pri srpastocelični dispoziciji in srpastocelični anemiji
English: • 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 enlarge spleen (splenomegaly) or possibly rupture of spleen).
Slovenian: • bolečine v zgornjem delu trebuha, bolečine pod prsnim košem na levi strani ali bolečine na vrhu levega ramena (to so lahko simptomi povečanja vranice (splenomegalija) ali morebitnega raztrganja vranice);
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Slovenian: V kliničnih preskušanjih z bolniki z rakom je bila mišično-skeletna bolečina blaga ali zmerna pri
English: Transfusion reactione a See section 4.8, Description of selected adverse reactions b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section 4.8, Description of selected adverse reactions) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain,
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih reakcija na transfuzijoe aglejte poglavje 4.8, Opis izbranih neželenih učinkov bObstajajo poročila o reakcijah presadka proti gostitelju in smrtnih primerih bolnikov po alogenski presaditvi kostnega mozga (glejte poglavje 4.8, Opis izbranih neželenih učinkov)
English: What Accofil is used for
Slovenian: Za kaj uporabljamo zdravilo Accofil
English: If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day.
Slovenian: Če darujete matične celice za drugo osebo, potem je običajni odmerek na kilogram telesne mase 1 milijon enot (10 mikrogramov) vsak dan. Zdravljenje z zdravilom Accofil bo trajalo 4 do 5 dni.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Slovenian: Posebna opozorila in previdnostni ukrepi za vse indikacije Zdravilo Filgrastim se ne sme uporabljati za povečanje odmerka citotoksične kemoterapije zunaj uveljavljenih shem odmerjanja.
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Slovenian: • boleče izbočene rane vijolične barve na okončinah in včasih na obrazu in vratu z zvišano telesno temperaturo (Sweetov sindrom) • poslabšanje revmatoidnega artrtitisa
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)
Slovenian: • občutljivost in otekanje sluznice prebavil, ki poteka od ust do zadnjika (sluznično vnetje)
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Slovenian: • zmanjšana občutljivost, zlasti kože (hipestezija) • mravljinčenje ali odrevenelost dlani ali stopal (parestezija)
English: (Chondrocalcino sis
Slovenian: (pirofosfa tna hondrokal cinoza)
English: Name and address of the manufacturer(s) responsible for batch release Accord Healthcare Ltd.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena brizga vsebuje 30 M e. filgrastima v 0,5 ml (0,6 mg/ml).
English: 0.5 ml
Slovenian: 9/L.
English: Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi koncentrirana ocetna kislina natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
English: Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Slovenian: Zdravljenje s filgrastimom samim ne prepreči trombocitopenije in anemije, povzročenih z mielosupresivnimi zdravili.
English: • Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.
Slovenian: jezika ali drugih delov telesa, kratka sapa, sopenje ali težave z dihanjem (to so lahko znaki hude alergijske reakcije);
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 - 5 consecutive days.
Slovenian: Za izplavljanje matičnih celic v periferno kri pri zdravih dajalcih je treba filgrastim 4-5 zaporednih dni uporabljati v odmerku 1,0 M e. (10 µg)/kg/dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena brizga vsebuje 48 M e. filgrastima v 0,5 ml (0,96 mg/ml).
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 µg/kg/day).
Slovenian: Pri manj kot 5 % bolnikov, ki so prejemali filgrastim v odmerku, večjem od 0,3 M e./kg/dan (3 mikrograme/kg/dan), so opazili število belih krvnih celic, 100 x 109/L ali več.
English: Leukocytosisa Splenic rupturea Sickle cell anaemia with crisis
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegal ijaa znižane ravni hemoglobin ae levkocitozaa raztrganje vranicea srpastocel ična anemija s krizo
English: If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing filgrastim should be carefully weighed; filgrastim should be discontinued if MDS or leukaemia occurs.
Slovenian: Če se pri bolnikih s hudo kronično nevtropenijo pojavijo nenormalne citogenetske spremembe, je treba natančno pretehtati tveganja in koristi nadaljnjega zdravljenja s filgrastimom.
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm3.
Slovenian: Pri bolnikih, pri katerih se razvije trombocitopenija, tj. število trombocitov je ves čas < 100.000/mm3, je treba razmisliti o začasnem prenehanju zdravljenja ali o zmanjšanju odmerka filgrastima.
English: Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MU (5 µg)/kg/day as a single dose or in divided doses.
Slovenian: Priporočeni začetni odmerek je 0,5 M e. (5 µg)/kg/dan v enkratnem odmerku ali v deljenih odmerkih.
English: Cases of splenomegaly have been reported commonly following administration of filgrastim.
Slovenian: Po dajanju filgrastima so pogosto poročali o primerih splenomegalije.
English: NAME OF THE MEDICINAL PRODUCT Accofil 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Slovenian: IME ZDRAVILA Accofil 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 48 MU/0.5 ml solution for injection/infusion filgrastim
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Accofil 48 M e./0,5 ml raztopina za injiciranje/infundiranje filgrastim s.c./i.v.
English: In patients with severe chronic neutropenia (SCN)
Slovenian: Bolniki s hudo kronično nevtropenijo
English: Aortitis
Slovenian: Imunogenost
English: Each ml of solution contains 50 mg of sorbitol (E420) For the full list of excipients, see section 6.1.
Slovenian: En ml raztopine vsebuje 50 mg sorbitola (E420).
English: • bone density decreased
Slovenian: • zmanjšanje gostote kosti
English: Blood alkaline phosphatase increased Hepatomegaly
Slovenian: žolčnika in žolčevodov povečane ravni alkalne fosfataze v krvi povečane ravni gamaglutamiltran sferaze
English: How to store Accofil
Slovenian: Shranjevanje zdravila Accofil
English: NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Slovenian: IME ZDRAVILA Accofil 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Accofil 30 M e./0,5 ml raztopina za injiciranje/infundiranje filgrastim s.c./i.v.
English: Decreased Appetitee Blood lactate dehydrogenase increased
Slovenian: Presnovne in prehranske motnje zmanjšan apetite povečane ravni hiperurikemi ja povečane ravni sečne zmanjšanj e ravni glukoze v krvi
English: Capillary leak syndrome
Slovenian: Preobrazba v levkemijo ali mielodisplatični sindrom
English: EU/1/14/946/003 - 1 prefilled syringe EU/1/14/946/004 - 5 prefilled syringes EU/1/14/946/012 - 3 prefilled syringe EU/1/14/946/015 - 10 prefilled syringe
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/14/946/003 − 1 napolnjena injekcijska brizga EU/1/14/946/004 − 5 napolnjenih injekcijskih brizg EU/1/14/946/012 − 3 napolnjene injekcijske brizge
English: Respiratory failurea
Slovenian: • mišični krči
English: Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell trait or sickle cell disease.
Slovenian: Med uporabo filgrastima pri osebah s srpastocelično dispozicijo ali srpastocelično anemijo so poročali o srpastoceličnih krizah, ki so bile v nekaterih primerih usodne.
English: EU/1/14/946/001 - 1 prefilled syringe EU/1/14/946/002 - 5 prefilled syringes EU/1/14/946/006 - 3 prefilled syringe EU/1/14/946/009 - 10 prefilled syringe
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/14/946/001 − 1 napolnjena injekcijska brizga EU/1/14/946/002 − 5 napolnjenih injekcijskih brizg EU/1/14/946/006 − 3 napolnjene injekcijske brizge
English: • increase in white blood cells (leukocytosis)
Slovenian: • povečanje števila belih krvnih celic (levkocitoza) • alergijska reakcija (preobčutljivost)
English: Diarrhoeaa,e Vomitinga,e Nauseaa
Slovenian: Bolezni prebavil driskaa,e bruhanjea,e navzeaa zaprtjee bolečina v ustih
English: For mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5-7 consecutive days.
Slovenian: Če se filgrastim uporablja samostojno, je priporočeni odmerek za izplavljanje PBPC 1,0 M e. (10 µg) kg/dan 5-7 zaporednih dni.
English: Talk to your doctor before using Accofil:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Accofil Ne uporabljajte zdravila Accofil
English: Thrombocytopenia has been reported commonly in patients receiving filgrastim.
Slovenian: Pri bolnikih, ki prejemajo filgrastim, so pogosto poročali o trombocitopeniji.
English: Filgrastim for PBPCs for mobilisation in normal donors prior to allogeneic PBPC transplantation Filgrastim should be given by subcutaneous injection.
Slovenian: Če se filgrastim uporablja za izplavljanje PBPC pri zdravih dajalcih pred alogensko presaditvijo PBPC
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Slovenian: Po dajanju filgrastima so občasno poročali o primerih splenomegalije in raztrganja vranice.
English: Common side effects (seen in more than 1 in 100 people taking Accofil):
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 100 oseb, ki uporabljajo zdravilo Accofil)
English: Always use Accofil exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Accofil natančno upoštevajte zdravnikova navodila.
English: Rare side effects (seen in more than 1 in 10,000 people taking Accofil):
Slovenian: Redki neželeni učinki (pojavijo se lahko pri več kot 1 od 10.000 oseb, ki uporabljajo zdravilo
English: Injection site reaction
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA
English: Pulmonary oedemaa
Slovenian: Kožni vaskulitis
English: Blood uric acid increased
Slovenian: ekstramedularno hematopoezo in povečanjem vranice.
English: Acute respiratory distress syndromea
Slovenian: Psihiatrične motnje nespečnost
English: musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e
Slovenian: Za izplavljanje krvotvornih matičnih celic v periferno kri (PBPC) pri bolnikih, pri katerih se izvaja mielosupresivno ali mieloablacijsko zdravljenje, ki mu sledi avtologna presaditev PBPC
English: Anaphylact ic reaction
Slovenian: motnje volumna tekočine
English: • vomiting
Slovenian: • zaprtost
English: Hyperuricaemia Blood uric acid increased
Slovenian: Žilne bolezni hipotenzija hipertenzija venskookluzivna bolezend sindrom povečane prepusnos ti kapilara aortitis
English: Lung infiltrationa
Slovenian: Prirojena nevtropenija
English: musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
Slovenian: cVključuje bolečine v kosteh, bolečine v hrbtu, artralgiji, mialgijo, bolečine v okončinah, mišično skeletne bolečine, mišično-skeletne bolečine v prsnem košu, bolečine v vratu dPrimere so opazili v obdobju trženja filgrastima pri bolnikih, pri katerih je bila opravljena presaditev kostnega mozga ali je potekalo izplavljanje PBPC
English: Not know n
Slovenian: Neznana pogostno st
English: Sweets syndrome (acute febrile neutrophilic dermatosis) Cutaneous vasculitisa
Slovenian: Žilne bolezni hipotenzija hipertenzija venskookluzivna bolezend sindrom povečane prepustno sti kapilara aortitis
English: Sepsis
Slovenian: • navzea
English: ATCvet code: QI06AH10.
Slovenian: Oznaka ATCvet QI06AH10
English: Shelf life after reconstitution according to directions: use immediately.
Slovenian: Rok uporabnosti po rekonstituciji v skladu z navodili: uporabite takoj
English: Store and transport refrigerated.
Slovenian: Shranjujte in prevažajtev hladilniku.
English: EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Slovenian: EU/2/04/048/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/048/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov izdelovalcev bioloških zdravilnih učinkovin: