FrancophonIA/ELRC3.0 huggingface dataset:
English: Idiopathic or cyclic neutropenia
Slovenian: Idiopatska ali ciklična nevtropenija
English: > 1.0 x 109/l for 3 consecutive days
Slovenian: > 1,0 x 109/l v obdobju treh zaporednih dni
English: The usual dose varies depending on your illness and weight.
Slovenian: Običajni odmerek se razlikuje glede na vašo bolezen in telesno maso.
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Slovenian: Zdi se, da deleži, ki so večji od tega, korelirajo s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
English: Please tell your doctor immediately during treatment:
Slovenian: Takoj med zdravljenjem povejte svojemu zdravniku:
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Slovenian: Vaš zdravnik vas bo morda skrbno spremljal, glejte poglavje 4 navodila za uporabo.
English: Geriatric use
Slovenian: Geriatrična uporaba
English: Overall, reports were more common after IV administration.
Slovenian: Na splošno so bila ta poročila pogostejša po intravenskem dajanju.
English: Causes of transient neutropenia, such as viral infections should be excluded.
Slovenian: Izključiti je treba vzroke prehodne nevtropenije, npr. virusne okužbe.
English: • trouble sleeping (insomnia)
Slovenian: • težave s spanjem (insomnija)
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Slovenian: Zmanjšanje števila belih krvnih celic (nevtropenija) se lahko pojavi zaradi več razlogov in povzroči manjšo sposobnost telesa v boju proti okužbam.
English: If you think you have injected more than you should, contact your doctor as soon as possible.
Slovenian: Če menite, da ste injicirali večji odmerek, kot bi smeli, se čim prej posvetujte z zdravnikom.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Slovenian: Časovni razpored levkafereze: pogosto zadošča(ta) ena ali dve levkaferezi 5. in 6. dan.
English: Thereafter, it is recommended that the ANC is measured at least twice per week for the first 2 weeks and subsequently once per week or once every other week during maintenance therapy.
Slovenian: Pozneje pa je priporočljivo absolutno število levkocitov določati vsaj dvakrat na teden prva dva tedna, nato pa enkrat na teden ali enkrat na dva tedna med vzdrževalnim zdravljenjem.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki brizge poleg oznake "EXP".
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Slovenian: Rezultati meritev števila celic CD34+ s pretočno citometrijo se razlikujejo glede na dejansko uporabljeno metodologijo in priporočila o številu, ki temeljijo na študijah v drugih laboratorijih, je treba razlagati previdno.
English: • increase of certain enzymes in the blood
Slovenian: • povečanje vrednosti določenih encimov v krvi
English: Some cases of splenic rupture were fatal (see section 4.4).
Slovenian: Nekateri primeri raztrganja vranice so bili usodni (glejte poglavje 4.4).
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Slovenian: Na podlagi študije uporabe posamičnih odmerkov obstaja nekaj dokazov, da lahko intravensko odmerjanje skrajša trajanje učinka.
English: Only clear solutions without particles should be used.
Slovenian: Uporabiti se sme samo bistro raztopino brez delcev.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Slovenian: G-CSF lahko spodbudi rast mieloičnih celic in vitro in podobne učinke je mogoče videti na nekaterih ne mieloičnih celicah in vitro.
English: Do not increase the dose your doctor has given you.
Slovenian: Ne povečujte odmerka, ki ga je predpisal zdravnik.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Slovenian: Pri izbiri metode za izplavljanje je treba upoštevati splošne cilje zdravljenja pri posameznem bolniku.
English: The stem cells will then go back into the bone marrow and produce blood cells;
Slovenian: Matične celice se nato vrnejo v kostni mozeg in proizvajajo krvne celice;
English: The clinical relevance of this finding to multiple dose administration is not clear.
Slovenian: Klinični pomen tega opažanja za uporabo več odmerkov zapored ni jasen.
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (Filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Slovenian: Prospektivnih randomiziranih primerjav dveh priporočenih metod za izplavljanje (filgrastim samostojno ali v kombinaciji z mielosupresivno kemoterapijo) znotraj iste populacije bolnikov ni na voljo.
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Slovenian: Priporoča se, da center za odvzem krvi sistematično beleži in spremlja darovalce izvornih celic vsaj še deset let ter darovalcem tako zagotovi dolgoročno varnost.
English: Effect of chemotherapy on erythrocytes and thrombocytes
Slovenian: Vpliv kemoterapije na eritrocite in trombocite
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Slovenian: • pred visokimi odmerki kemoterapije, da kostni mozeg proizvaja več matičnih celic, ki jih je mogoče odvzeti in vrniti po zdravljenju.
English: Medicines (containing sorbitol/fructose) given intravenously may be lifethreatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Slovenian: Zdravila, ki vsebujejo sorbitol/fruktozo, aplicirana intravensko, so lahko življenjsko ogrožujoča in morajo biti pri tej starostni skupini kontraindicirana, razen če so klinično nujno potrebna in če na voljo ni druge alternative.
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Slovenian: Po vpeljani kemoterapiji za zdravljenje čvrstih tumorjev, limfomov in limfatične levkemije je pričakovati, da bo trajanje zdravljenja, ki je potrebno za izpolnitev teh meril, znašalo do 14 dni.
English: Regular urinalysis should be performed to monitor these events.
Slovenian: Za spremljanje teh pojavov je treba redno izvajati analize urina.
English: Clean the skin at the injection site using an alcohol wipe.
Slovenian: Očistite kožo na mestu injiciranja z alkoholno blazinico.
English: In patients with HIV infection
Slovenian: Pri bolnikih z okužbo s HIV
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Slovenian: Petinšestdeset odstotkov bolnikov, ki so jih preučevali v programu študij hude kronične nevtropenije, je bilo mlajših od 18 let.
English: * recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in E. coli by recombinant DNA technology.
Slovenian: * rekombinantni metionilirani humani granulocitne kolonije spodbujajoči faktor (G-CSF - granulocyte colony stimulating factor), ki ga po tehnologiji rekombinantne DNK tvori E. coli.
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Slovenian: Če ste izpustili injekcijo ali ste injicirali premalo, se čim prej posvetujte z zdravnikom.
English: Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Slovenian: Velikosti pakiranj so 1, 3, 5 ali 10 napolnjenih injekcijskih brizg.
English: Insert the needle into the skin fold with a quick, firm action.
Slovenian: Iglo v kožo zabodite hitro in odločno.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Slovenian: Podatki v spodnjih razpredelnicah opisujejo neželene učinke, o katerih so poročali iz kliničnih preskušanj in spontanega poročanja.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Slovenian: • vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Slovenian: Če opazite prenehanje odzivanja ali neuspešno ohranjanje odziva na filgrastim, bo zdravnik raziskal razloge za to, vključno s pojavom protiteles, ki nevtralizirajo delovanje filgrastima.
English: (Sweets syndrome)
Slovenian: (Sweetov sindrom)
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Slovenian: Splošnih razlik v varnosti ali učinkovitosti pri osebah, starejših od 65 let, v primerjavi z mlajšimi odraslimi (> 18 let starosti) osebami, ki so prejemale citotoksično kemoterapijo, niso opazili, klinične izkušnje pa niso pokazale razlik v odzivu med starejšimi in mlajšimi odraslimi bolniki.
English: Rates of generation of antibodies against filgrastim is generally low.
Slovenian: Stopnje nastajanja protiteles proti filgrastimu so običajno nizke.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja med uporabo in razmere pred uporabo odgovoren uporabnik, Ta čas pa običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je razredčenje opravljeno v nadzorovanih in preverjenih (validiranih) aseptičnih razmerah.
English: Syringes are embossed with graduation rings in order to enable partial use if required.
Slovenian: Injekcijske brizge imajo vtisnjene merilne obročke, ki omogočajo delno uporabo, če je to potrebno.
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 vročino
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Slovenian: Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo akutno mieloično levkemijo, ki so mlajši od 55 let in imajo dobro citogenetiko [t(8;21), t(15;17) in inv(16)], nista bili dokazani.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Slovenian: Statistična analiza razmerja med številom ponovno infundiranih celic CD34+ in hitrostjo obnove trombocitov po kemoterapiji v velikih odmerkih kaže zapleteno, vendar stalno medsebojno povezavo.
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.
Slovenian: Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev (G-CSFs) mora biti dajanje zdravila Filgrastim HEXAL jasno zabeležno v zdravstveni kartoteki bolnika.
English: Use each syringe only for one injection.
Slovenian: Vsako brizgo uporabite le za eno injiciranje.
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Slovenian: • pljuča ne delujejo, kot bi morala, kar povzroča zasoplost (dihalna odpoved)
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Slovenian: V nekaterih primerih so se simptomi ob ponovni izpostavitvi zdravilu ponovili, kar nakazuje vzročno povezavo.
English: Filgrastim HEXAL is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Slovenian: Zdravilo Filgrastim HEXAL se običajno daje kot vsakodnevna injekcija v tkivo tik pod kožo (kar se imenuje podkožna injekcija).
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Slovenian: Daje se lahko tudi v obliki počasne injekcije v žilo (kar se imenuje intravenska infuzija).
English: 1995 - 2000b a Analysis includes studies involving BM transplant during this period; some studies used GM-CSF b Analysis includes patients receiving BM transplant during this period
Slovenian: 1995 - 2000b a Analiza obsega študije, ki vključujejo presaditve kostnega mozga v tem časovnem obdobju; v nekaterih študijah je bila uporabljena GM-CSF
English: If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če ste negotovi glede dajanja injekcije ali pa imate kakršna koli vprašanja, prosite za pomoč svojega zdravnika ali medicinsko sestro.
English: Each graduation ring corresponds to a volume of 0.1 ml.
Slovenian: Vsak merilni obroček ustreza volumnu 0,1 ml.
English: How is Filgrastim HEXAL given and how much should I take?
Slovenian: Kako se daje zdravilo Filgrastim HEXAL in koliko ga naj vzamem?
English: When diluted in glucose 50 mg/ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Slovenian: Če je razredčen s 5 % (50 mg/ml) raztopino glukoze, je filgrastim kompatibilen s steklom in različnimi plastičnimi materiali, vključno s PVC, poliolefinom (kopolimerom polipropilena in polietilena) in polipropilenom.
English: Haematuria was common and proteinuria occurred in a small number of patients.
Slovenian: Hematurija je bila pogosta, pri majhnem številu bolnikov pa se je pojavila proteinurija.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Slovenian: Učinki filgrastima na prenatalni razvoj so bili preučeni pri podganah in kuncih.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Slovenian: Varnost in učinkovitost filgrastima, uporabljenega na isti dan kot je bila uporabljena mielosupresivna citotoksična kemoterapija, nista bili dokončno potrjeni.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Slovenian: Tako kot drugi hematopoetski rastni faktorji tudi G-CSF in vitro spodbuja človeške endotelijske celice.
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Slovenian: Najmanjši priporočeni delež ≥ 2,0 x 106 CD34+ celic/kg temelji na objavljenih podatkih, po katerih je to število zadostovalo za hematološko obnovo.
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-fluorouracil indicates that the severity of neutropenia may be exacerbated.
Slovenian: Preliminarni podatki, dobljeni pri manjšem številu bolnikov, ki so se sočasno zdravili s filgrastimom in 5-fluorouracilom, kažejo, da se stopnja izraženosti nevtropenije lahko še poveča.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Slovenian: Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je minil po ukinitvi G
English: • if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Slovenian: • če se zdravite zaradi hude kronične nevtropenije in imate kri v urinu (hematurija).
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Slovenian: Če ste bolnik s hudo kronično nevtropenijo, obstaja tveganje, da se pri vas razvije krvni rak (levkemija, mielodisplastični sindrom [MDS]).
English: Then, if ANC remains > 1.0 x 109/l for 3 more consecutive days
Slovenian: Nato, če ANC ostane > 1,0 x 109/l še v obdobju naslednjih treh zaporednih dni
English: In patients with severe chronic neutropenia (SCN)
Slovenian: Pri bolnikih s hudo kronično nevtropenijo (SCN - Severe Chronic Neutropenia)
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 pri bolnikih z rakom je bila mišično-skeletna bolečina blaga do zmerna pri 10 % bolnikov in huda pri 3 % bolnikov.
English: The effects of filgrastim overdosage have not been established.
Slovenian: Učinki prevelikega odmerjanja filgrastima niso bili ugotovljeni.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Slovenian: To so lahko simptomi stanja, imenovanega "sepsa" (ali "zastrupitev krvi"), hude okužbe z vnetnim odzivom celotnega telesa, ki je lahko smrtno nevarna in zahteva nujno zdravniško pomoč.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
Slovenian: Randomizirana, dvojno slepa, po enkratnem in večkratnem odmerku, navzkrižna študija na 204 zdravih prostovoljcih kaže, da je farmakokinetični profil zdravila Filgrastim HEXAL primerljiv s farmakokinetičnim profilom referenčnega zdravila po subkutani in intravenski uporabi.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncologyhaematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Slovenian: Postopki izplavljanja (mobilizacije) in afereze se morajo izvajati v sodelovanju z onkološkim-hematološkim središčem, ki ima sprejemljive izkušnje na tem področju, in kjer je mogoče neoporečno izvajati spremljanje hematopoetskih matičnih celic.
English: Risks associated with increased doses of chemotherapy
Slovenian: Tveganja, povezana z velikimi odmerki kemoterapije
English: Absolute neutrophil count (ANC) should be monitored closely, especially during the first few weeks of filgrastim therapy.
Slovenian: Absolutno število nevtrofilcev (ANC) je treba skrbno spremljati, zlasti v obdobju prvih nekaj tednov zdravljenja s filgrastimom.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities.
Slovenian: Zdravljenje s filgrastimom se lahko izvaja le v sodelovanju z onkološkim središčem, ki ima izkušnje z zdravljenjem z G-CSF in izkušnje v hematologiji, in razpolaga s potrebnimi diagnostičnimi zmogljivostmi.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim or pegfilgrastim.
Slovenian: Na splošno so dogodki glomerulonefritisa izzveneli z zmanjšanjem odmerka ali prenehanjem uporabe filgrastima ali pegfilgrastima.
English: Filgrastim HEXAL is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Slovenian: Zdravilo Filgrastim HEXAL je opremljeno z zaščito za iglo ali pa je brez nje, vaš zdravnik ali medicinska sestra pa vam bosta pokazala, kako to uporabljati.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Filgrastim HEXAL therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Filgrastim HEXAL, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Slovenian: Z levkaferezo je treba začeti peti dan in jo, če je potrebno, nadaljevati do šestega dne, da se zbere 4 x 106 celic CD34+/kg prejemnikove telesne mase.
English: Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless to slightly yellowish liquid.
Slovenian: Ne uporabljajte tega zdravila, če opazite obarvanje, motnost ali delce, saj mora biti tekočina bistra in brezbarvna do rahlo rumenkasta.
English: The efficacy of treatment was clear for this age-group, which included most patients with congenital neutropenia.
Slovenian: Učinkovitost zdravljenja v tej starostni skupini, v katero so bili vključeni večinoma bolniki s prirojeno nevtropenijo, je bila nedvoumna.
English: If partial use of a syringe is required, remove unwanted solution before injection.
Slovenian: Če je treba uporabiti le del vsebine injekcijske brizge, pred injiciranjem odstranite neželeno raztopino.
English: - The active substance is filgrastim.
Slovenian: - Učinkovina je filgrastim.
English: Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Slovenian: Nato je mogoče odmerek individualno prilagajati na vsak(a) 1 do 2 tedna, da se ohrani povprečno število nevtrofilcev med 1,5 x 109/l in 10 x 109/l.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 72 hours (but not above 25°C).
Slovenian: Brizgo lahko vzamete iz hladilnika in jo pustite na sobni temperaturi enkrat za največ 72 ur (pri temperaturi do 25 °C).
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Slovenian: Pri brejih podganah niso ugotovili toksičnih učinkov na samico ali plod pri odmerkih do 575 µg/kg/dan.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Slovenian: V takšnih primerih je treba z dajanjem filgrastima prenehati in uporabiti ustrezno zdravljenje.
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 avtoimunsko nevtropenijo nista bili ugotovljeni.
English: Inject the Filgrastim HEXAL solution as you have been shown by your doctor.
Slovenian: Raztopino zdravila Filgrastim HEXAL injicirajte tako, kot vam je pokazal zdravnik.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (pri temperaturi od 2 °C - 8 °C).
English: The incidence of fever and documented infections were not reduced in either setting.
Slovenian: Pogostnost pojavljanja zvišane telesne temperature in dokumentiranih okužb se v nobenem od teh primerov nista zmanjšali.
English: Among these, two cases of platelets < 50 x 109/l were reported and attributed to the leukapheresis procedure.
Slovenian: Med temi so v dveh primerih poročali o številu trombocitov < 50 x 109/l, kar so pripisovali postopku levkafereze.
English: In randomised clinical trials, a subcutaneous dose of 230 μg/m2/day (4.0 to 8.4 μg/kg/day) was used.
Slovenian: V randomiziranih kliničnih preskušanjih so uporabljali subkutani odmerek 230 µg/m2/dan (4,0 do 8,4 µg/kg/dan).