FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Slovenian: Relativno tveganje (95-% IZ) za GvHD in TRM po zdravljenju z G-CSF po presaditvi kostnega mozga
English: The excretion of filgrastim in milk has not been studied in animals.
Slovenian: Izločanja filgrastima v mleko pri živalih, niso raziskali.
English: If the patient is experiencing fatigue, caution is advised when driving a car or operating machines.
Slovenian: Če se bolnik počuti utrujenega, mora biti pri vožnji avtomobila ali pri upravljanju s stroji previden.
English: However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Slovenian: Ker pa je velik odstotek teh bolnikov obolelih za levkemijo (gre za stanje, za katerega vemo, da je povezano s Sweetovim sindromom), vzročna povezava s filgrastimom ni bila ugotovljena.
English: Each mL of solution contains 50 mg of sorbitol.
Slovenian: 1 ml raztopine vsebuje 50 mg sorbitola.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Slovenian: Pomembno je, da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
English: A risk of promotion of a malignant myeloid clone can not be excluded.
Slovenian: Tveganja za napredovanje mieloidnega rakastega klona ne moremo izključiti.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Slovenian: Postopek zbiranja in afereze bi moral potekati v sodelovanju z onkološko-hematološkim centrom, ki ima ustrezne izkušnje na tem področju in v katerem lahko na ustrezen način spremljajo krvotvorne matične celice.
English: The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Slovenian: Učinkovitost in varnost Biograstima sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne-Hodkinovim limfomom.
English: Inject the liquid slowly and evenly, always keeping your skin pinched.
Slovenian: Tekočino injicirajte počasi in enakomerno; pri tem ves čas s palcem in kazalcem držite kožno gubo.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Slovenian: Časovna razporeditev levkaferez: običajno zadostujeta 1 do 2 levkafrezi 5. in 6. dan.
English: Some cases of splenic rupture were fatal.
Slovenian: Nekateri primeri pretrganja vranice so bili usodni.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Slovenian: Faktor, ki spodbuja rast granulocitnih kolonij, lahko spodbudi rast mieloičnih celic in vitro; podobni učinki bi se lahko pojavili pri nekaterih nemieloičnih celicah in vitro.
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Slovenian: Še posebej previdni moramo biti, kadar je predpisano eno samo ali več kemoterapevtskih učinkovin, za katere se ve, da povzročajo hudo trombocitopenijo.
English: Your doctor or nurse will give you instructions on how to do this.
Slovenian: O tem vas bosta poučila vaš zdravnik ali medicinska sestra.
English: Your doctor will tell you why you are being treated with Biograstim.
Slovenian: Prav tako vam bo zdravnik razložil, zakaj se zdravite z zdravilom Biograstim.
English: The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
Slovenian: Občasno so poročali o pojavu Sweetovega sindroma (akutna febrilna dermatoza).
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Slovenian: Mehanizem kožnega vaskulitisa pri bolnikih, ki prejemajo filgrastmi, ni znan.
English: Unspecified pain
Slovenian: Občasni nespecifična bolečina
English: Filgrastim dosing should be maintained until the last leukapheresis.
Slovenian: Odmerjanje filgrastima naj traja vse do zadnje levkafereze.
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Slovenian: Pri ocenjevanju pridobljenih matičnih celic pri bolnikih, ki so prejemali filgrastim, je treba posebej paziti na metodo za ugotavljanje količinske sestave.
English: Infections and malignancies causing myelosuppression
Slovenian: Okužbe in maligna obolenja, ki povzročajo mielosupresijo
English: The amount of Biograstim you need, will depend on the condition you are taking Biograstim for and on your bodyweight.
Slovenian: Količina zdravila Biograstim, ki jo potrebujete, je odvisna od stanja, zaradi katerega morate jemati zdravilo, in od vaše telesne mase.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Slovenian: Če je število glede na zgornje kriterije prenizko, je potrebno razmisliti o alternativnih oblikah zdravljenja, pri katerih ni potrebe po matičnih celicah.
English: When a peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Slovenian: Če je predvidena presaditev matičnih celic iz periferne krvi, je zbiranje izvornih celic priporočljivo načrtovati v zgodnji fazi zdravljenja bolnika.
English: In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Slovenian: Ker obstaja tveganje mikrobne kontaminacije so z zdravilom Biograstim napolnjene brizge namenjene izključno enkratni uporabi.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Slovenian: Če imate kakršne koli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za pomoč in nasvet.
English: In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Slovenian: V randomiziranih, s placebom nadzorovanih kliničnih študijah, filgrastim ni povzročil zvečanja števila neželenih učinkov, povezanih s citotoksično kemoterapijo.
English: The causal association with filgrastim has not been established.
Slovenian: Vzročna povezava s filgrastimom ni bila ugotovljena.
English: - if you have sickle cell disease (an inherited disease characterised by sickle-shaped red blood cells).
Slovenian: - če imate srpasto anemijo (dedno bolezen, za katero so značilne srpasto oblikovane rdeče krvničke).
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 to 16 hours.
Slovenian: Po subkutanem aplikaciji priporočenih odmerkov je bila koncentracija seruma naslednjih 8 do 16 ur višja od 10 ng/ml.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Slovenian: Učinkovitost zdravljenja pri tej starostni skupini, v kateri so bili tudi bolniki s kongenitalno nevtropenijo, je bila jasna.
English: Take your Biograstim pre-filled syringe out of the refrigerator.
Slovenian: Vzemite napolnjeno injekcijsko brizgo z zdravilom Biograstim iz hladilnika.
English: Analysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) Analysis includes patients receiving bone marrow transplant during this period
Slovenian: 1995-2000b aAnaliza vključuje študije, ki zajemajo presaditev kostnega mozga v tem obdobju; nekatere študije uporabljajo GM-CSF (faktor, ki spodbuja rast granulocitno-makrofagnih kolonij) bAnaliza vključuje bolnike, ki jim je bil v tem obdobju presajen kostni mozeg
English: Your doctor has prescribed Biograstim for you to help your body make more white blood cells.
Slovenian: Zdravnik vam je predpisal zdravilo Biograstim zato, da bi vaše telo lahko proizvajalo več belih krvničk.
English: This observation has only been made in patients with congenital neutropenia.
Slovenian: Te nepravilnosti so bile opažene samo pri bolnikih s kongenitalno nevtropenijo.
English: ● Periodic Safety Update Reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Slovenian: Zdravilo Biograstim se uporablja za zbiranje perifernih krvotvornih matičnih celic (PBPC).
English: Splenic enlargement is a direct effect of treatment with filgrastim.
Slovenian: Zvečanje vranice je neposreden učinek zdravljenja s filgrastimom.
English: Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
Slovenian: Občasno so poročali o prehodnem zvišanju krvnega tlaka; klinično zdravljenje ni bilo potrebno.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - alcohol wipes or similar; - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Slovenian: Za subkutano samoinjiciranje boste potrebovali: - napolnjeno injekcijsko brizgo z zdravilom Biograstim, - alkoholne krpice ali podobno, - vsebnik, odporen na vbode (plastičen vsebnik, ki ga dobite v bolnišnici ali lekarni), tako da boste lahko varno odlagali uporabljene brizge brez varnostnega pripomočka.
English: What Biograstim is and what it is used for What you need to know before you use Biograstim How to use Biograstim
Slovenian: Kaj je zdravilo Biograstim in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Biograstim Kako uporabljati zdravilo Biograstim Možni neželeni učinki
English: - Never put the syringes that you have used into your normal household rubbish bin.
Slovenian: - Uporabljenih brizg nikoli ne odložite v koš, ki ga uporabljate za odlaganje ostalih gospodinjskih odpadkov.
English: Biograstim contains sorbitol.
Slovenian: Zdravilo Biograstim vsebuje sorbitol.
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Slovenian: Nekateri bolniki se lahko zelo hitro in z znatnim povečanjem števila nevtrofilcev odzovejo na začetni odmerek filgrastima.
English: Before you stop using Biograstim, talk to your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo Biograstim Preden prenehate uporabljati zdravilo Biograstim se pogovorite z vašim zdravnikom.
English: - Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported.
Slovenian: - Poročali so o alergijskih reakcijah, kot so izpuščaj na koži, dvignjeni in srbečimi predeli kože ter resne alergijske reakcije z oslabelostjo, padcem krvnega tlaka, težavami z dihanjem in otekanje obraza.
English: You may experience the following additional side effects:
Slovenian: Lahko se pojavijo še naslednji neželeni učinki:
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Slovenian: Razpolovni eliminacijski čas odstranjevanja filgrastima iz telesa znaša približno 3,5 ur; očistek znaša približno 0,6 ml/min/kg.
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Slovenian: Filgrastim (rekombinantni metionil-granulocitne kolonije stimulirajoči faktor, humani) pridobljen s pomočjo rekombinantne DNK tehnologije v Escherichia coli K802.
English: - It is important to contact your doctor immediately 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: - Zdravniku morate nemudoma povedati, če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov: oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino (zdravilne učinkovine) ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Only clear solutions without particles should be used.
Slovenian: Uporabite lahko samo bistre raztopine brez delcev.
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Slovenian: Nato se prva dva tedna merjenje absolutnega števila nevtrofilcev priporoča vsaj dvakrat tedensko, v nadaljevanju terapije pa enkrat tedensko.
English: There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Slovenian: Med zdravilom Biograstim in referenčnim zdravilom ni bilo očitne razlike v zvezi s trajanjem hude nevtropenije in nastanka febrilne nevtropenije.
English: Uncommon (may affect up to 1 in 100 people): - unspecified pain.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - nespecifična bolečina.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with filgrastim should be made taking into account the benefit of breast-feeding to the child and the benefit of filgrastim therapy to the woman.
Slovenian: Odločiti se je treba med nadaljevanjem/prenehanjem dojenja ali nadaljevanjem/prenehanjem zdravljenja s filgrastimom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja s filgrastimom za mater.
English: It is important that you dispose of used syringes in a puncture-proof container.
Slovenian: Pomembno je, da uporabljene brizge odložite v vsebnik odporen na vbode.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na napolnjeno brizgo, kar v bistvu pomeni 'brez natrija'.
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain.
Slovenian: Na diagnozo rupture vranice moramo biti pozorni pri darovalcih in/ali bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v predelu leve lopatice.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle with or without safety device to prevent needle stick injury and re-use.
Slovenian: Napolnjena injekcijska brizga stekla tipa I s trajno pritrjeno nerjavečo jekleno iglo in z varnostnim pripomočkom za preprečevanje poškodbe zaradi vboda z iglo in ponovne uporabe ali brez njega.
English: In patients with HIV
Slovenian: Bolniki s HIV
English: As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear.
Slovenian: Ker je zvečanje vranice pri bolnikih, okuženih s HIV, pogosto in ker je v različni meri prisotno pri večini bolnikov z AIDS-em, povezava s filgrastimom ni jasna.
English: In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
Slovenian: Pri vseh primerih so pri fizičnem pregledu odkrili blago ali zmerno povečanje, klinični potek bolezni pa je bil benigen; nobenemu bolniku niso postavili diagnoze za povečanje vranice in nobenemu bolniku je ni bilo potrebno kirurško odstraniti.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Slovenian: Zdravljenje s filgrastimom se lahko predpiše samo v sodelovanju z onkološkim centrom, ki ima izkušnje na področju zdravljenja s faktorji, ki spodbujajo rast granulocitnih kolonij (G-CSF) in hematologije, in ki razpolaga z ustreznimi diagnostičnimi pripomočki.
English: The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Slovenian: Pojav pljučnih znakov kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov in poslabšanje pljučne funkcije utegnejo biti preliminarni znaki sindroma dihalne stiske pri odraslih (ARDS - 'Adult Respiratory Distress Syndrome').
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Slovenian: Glede na podatke o omejeni varnosti in učinkovitosti je treba filgrastim bolnikom s sekundarno AML odmerjati previdno.
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Biograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Slovenian: Če je razredčeno v glukozi 50 mg/ml (5 %) raztopini za infundiranje, je zdravilo Biograstim kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
English: Box for the prescribed dose
Slovenian: Škatla za predpisani odmerek
English: Your doctor might check your bone density regularly.
Slovenian: Zdravnik bo morda redno preverjal gostoto kosti.
English: The subcutaneous route is preferred in most cases.
Slovenian: V večini primerov se priporoča subkutana uporaba.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens (see below).
Slovenian: Filgrastima ne smete uporabljati za povečanje odmerka citotoksične kemoterapije izven uveljavljenih shem odmerjanja (glejte spodaj).
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Slovenian: Učinki filgrastima na bolnike z znatno zmanjšanim številom matičnih celic mieloične vrste niso bili raziskani.
English: Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Slovenian: Razkužite si kožo z alkoholno krpico in primite kožo s palcem in kazalcem, ne da bi jo stiskali (glejte sliko 5).
English: This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Slovenian: S pomočjo teh izidov bo vaš zdravnik vedel, kako dobro napreduje zdravljenje, prav tako pa se na podlagi teh podatkov odločil, ali je nadaljevanje zdravljenja potrebno ali ne.
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “capillary leak syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Slovenian: To so lahko simptomi občasne motnje (pojavi se lahko pri do 1 od 100 bolnikov), imenovane "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu, ki zahteva nujno zdravniško pomoč.
English: Talk to your doctor, pharmacist or nurse before using Biograstim - if you experience a cough, fever and difficulty breathing.
Slovenian: Pred začetkom uporabe zdravila Biograstim se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro - če začnete kašljati, se vam zviša telesna temperatura in se začnejo težave z dihanjem.
English: - if you have specific blood disorders (e.g. Kostman's syndrome, myelodysplastic syndrome,
Slovenian: - če imate specifične krvne motnje (npr. Kostmannov sindrom, mielodisplastični sindrom, različne vrste levkemije).
English: Biograstim and chemotherapy
Slovenian: Zdravilo Biograstim in kemoterapija
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Slovenian: Očistek filgrastima kaže, da sledi farmakokinetiki prvega reda tako pri subkutanem kot pri intravenskem apliciranju.
English: In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
Slovenian: V kliničnih preskušanjih so pri 97 % bolnikov, ki so se odzvali na zdravljenje, zabeležili popoln odgovor na odmerke v vrednosti ≤ 2,4 x 106i.e.
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Slovenian: Varnost in učinkovitost zdravila filgrastim pri običajnih darovalcih, mlajših od 16 let ali starejših od 60 let, nista bili ocenjeni.
English: Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Slovenian: Filgrastima ne smete predpisati bolnikom s hudo kongenitalno nevtropenijo (Kostmanov sindrom) s citogenetsko abnormalnostjo (glejte spodaj).
English: Increases in volume, measured radiographically, occurred early during filgrastim therapy and tended to plateau.
Slovenian: Povečanje, zmerjeno z radiografijo, se je pojavilo v zgodnji fazi zdravljenja s filgrastimom, nato pa se je umirilo.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Slovenian: Varnost in učinkovitost pri novorojenčkih in bolnikih z avtoimuno nevtropenijo nista bili ugotovljeni.
English: Biograstim is a biosimilar medicinal product.
Slovenian: Biograstim je biološko podobno zdravilo.
English: Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Slovenian: Zaradi tega lahko pri bolnikih z zmanjšanim številom prekurzorjev pride tudi do manjšega odziva nevtrofilcev (kot npr. pri bolnikih, ki prejemajo dolgotrajno radioterapijo ali kemoterapijo, ali pri tistih, pri katerih je prišlo do infiltracije kostnega mozga s tumorjem).
English: Symptoms suggestive of severe allergic reactions have been reported very rarely.
Slovenian: Zelo redko so poročali o simptomih, ki nakazujejo resne alergijske reakcije.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
Slovenian: Če je zdravilo Biograstim pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
English: The significance of these changes in terms of the development of haematological malignancy is unknown.
Slovenian: Ni znano ali imajo te spremembe velik vpliv na razvoj hematološke maligne bolezni.
English: Biograstim does not contain any preservative.
Slovenian: Zdravilo Biograstim ne vsebuje konzervansov.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Slovenian: Predklinični podatki iz konvencionalnih študij toksičnosti pri ponavljajočih odmerkih so razkrili pričakovane farmakološke učinke, ki so zajemali zvišanje števila levkocitov, mieloidno hiperplazijo v kostnem mozgu, ekstramedularno hematopoezo in povečanje vranice.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Slovenian: V literaturi navajajo primere prehoda filgrastima preko placente pri nosečnicah.