FrancophonIA/ELRC3.0 huggingface dataset:
English: Take your Filgrastim ratiopharm pre-filled syringe out of the refrigerator.
Slovenian: Vzemite napolnjeno injekcijsko brizgo z zdravilom Filgrastim ratiopharm iz hladilnika.
English: 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: If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion.
Slovenian: Če je potrebno, lahko zdravilo Filgrastim ratiopharm razredčite v glukozi 50 mg/ml (5%) raztopini za infundiranje.
English: Do not use Filgrastim ratiopharm after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Slovenian: Zdravila Filgrastim ratiopharm ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na napolnjeni injekcijski brizgi poleg oznake 'uporabno do'.
English: - neutropenia in patients with HIV infection, - peripheral blood stem cell mobilisation.
Slovenian: - nevtropenija pri bolnikih, okuženih s HIV - zbiranje matičnih celic iz periferne krvi
English: How do I prepare my Filgrastim ratiopharm injection?
Slovenian: Kako si pripravim z zdravilom Filgrastim ratiopharm napolnjeno injekcijo?
English: In view of the possible risk of microbial contamination, Filgrastim ratiopharm syringes are for single use only.
Slovenian: Ker obstaja tveganje mikrobne kontaminacije so z zdravilom ratiofrastim napolnjene brizge namenjene izključno enkratni uporabi.
English: Filgrastim ratiopharm is a clear and colourless solution.
Slovenian: Zdravilo Filgrastim ratiopharm je bistra in brezbarvna raztopina.
English: Your doctor has prescribed Filgrastim ratiopharm for you to help your body make more white blood cells.
Slovenian: Za kaj se uporablja zdravilo Filgrastim ratiopharm Zdravnik vam je predpisal zdravilo Filgrastim ratiopharm zato, da bi vaše telo lahko proizvajalo več belih krvničk.
English: Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section
Slovenian: Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje
English: Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Slovenian: Zdravila Filgrastim ratiopharm ne smemo mešati z raztopino natrijevega klorida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov mednarodnih enot [i.e.] (600 µg) filgrastima.
English: Filgrastim ratiopharm contains sorbitol.
Slovenian: Zdravilo Filgrastim ratiopharm vsebuje sorbitol.
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μg) should be given with
Slovenian: Primer: v injekciji s končnim volumnom 20 ml morate k celotnemu odmerku filgrastima z manj kot 30 x 106 i.e.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and local tolerance.
Slovenian: Podatki, ki niso pridobljeni v okviru kliničnih raziskav in ki temeljijo na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in lokalne tolerance, ne kažejo posebnega tveganja za človeka.
English: - cough, fever and difficulty breathing or coughing up blood (frequency unknown) - feeling sick, vomiting, constipation, diarrhoea, loss of appetite, mucositis (painful inflammation and ulceration of the mucous membranes lining the digestive tract) - pains or difficulties in passing urine (very rare), blood in the urine, protein in the urine
Slovenian: - občutek slabosti, bruhanje, zaprtje, diareja, izguba apetita, vnetje sluznice (boleče vnetje in razjeda sluznice, ki obdaja prebavni trakt) - bolečine ali težave pri uriniranju (zelo redko); kri v urinu; beljakovine v urinu
English: You will normally receive your first dose of Filgrastim ratiopharm at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Slovenian: Običajno boste prvi odmerek zdravila Filgrastim ratiopharm prejeli šele 24 ur po kemoterapiji, v primeru presaditve kostnega mozga pa boste zdravili prejeli v roku 24-ih ur.
English: It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Slovenian: Če začutite bolečino levo zgoraj v trebuhu ali v predelu levega ramena, takoj poiščite zdravniško pomoč, saj lahko te bolečine nakazujejo težave z vranico.
English: Some cases of splenic rupture were fatal.
Slovenian: Za nekatere bolnike je bila ruptura vranice usodna.
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Slovenian: Če dokončno ukinemo zdravljenje s filgrastimom, število nevtrofilcev v obtoku 1. ali 2. dan za tem pade za 50%, na običajno raven pa se povrne v obdobju od 1 do 7 dni.
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Slovenian: Primer: V injekciji s končnim volumnom 20 ml, morate k celotnemu odmerku filgrastima z manj kot 30 x 106 i.e. (300 μg) dodati 0,2 ml 20% raztopine humanega albumina.
English: Allergic-type reactions to filgrastim, including skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing and swelling of the face) have been reported.
Slovenian: Poročali so tudi o alergijskih reakcijah na filgrastim, vključno z izpuščajem na koži, dvignjenimi in srbečimi predeli kože in anafilaksijo (oslabelost, padec krvnega tlaka, težave z dihanjem in otekanje obraza).
English: Filgrastim ratiopharm treatment will last for 4 to 5 days.
Slovenian: Zdravljenje z zdravilom Filgrastim ratiopharm bo trajalo 4
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to
Slovenian: Še posebej previdni moramo biti, kadar je predpisano eno samo ali več kemoterapevtskih učinkovin, za katere se ve, da povzročajo hudo trombocitopenijo.
English: Pulmonary infiltrates
Slovenian: Zelo redki pljučni infiltrati
English: If you use more Filgrastim ratiopharm than you should If you use more Filgrastim ratiopharm than you should, contact your doctor or pharmacist as soon as
Slovenian: Če ste uporabili večji odmerek zdravila Filgrastim ratiopharm, kot bi smeli Če ste uporabili večji odmerek zdravila Filgrastim ratiopharm, kot bi smeli, se čimprej posvetujte z
English: What Filgrastim ratiopharm is and what it is used for
Slovenian: KAJ JE ZDRAVILO Filgrastim ratiopharm IN ZA KAJ GA UPORABLJAMO
English: Your doctor will monitor your blood to determine the best time to
Slovenian: Vaš zdravnik bo spremljal vašo kri, zato da določi najprimernejši čas za zbiranje izvornih celic.
English: - if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Filgrastim ratiopharm.
Slovenian: Ne uporabljajte zdravila Filgrastim ratiopharm - če ste alergični (preobčutljivi) na filgrastim ali katerokoli sestavino zdravila Filgrastim ratiopharm.
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: Predhodni podatki, pridobljeni na podlagi opazovanj manjšega števila bolnikov, kažejo, da sočasna uporaba zdravila filgrastim in 5-Fluorouracila okrepi
English: - Put used syringes into the puncture-proof container and keep this container out of the reach and
Slovenian: - Uporabljene brizge odložite v vsebnik, odporen na vbode; vsebnik hranite izven dosega otrok.
English: Filgrastim ratiopharm does not contain any preservative.
Slovenian: Zdravilo Filgrastim ratiopharm ne vsebuje konzervansov.
English: Leukocytosis, thrombocytopenia
Slovenian: Zelo pogosti levkocitoza, trombocitopenija
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
Slovenian: Filgrastim se lahko daje dnevno v obliki subkutane injekcije ali v obliki 30-minutne intravenske infuzije, raztopljene v 50 mg/ml (5%) glukoze v obliki raztopine za infundiranje (postopek redčenja je opisan v poglavju 6.6).
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Slovenian: Preobrazba v levkemijo ali mielodisplatični sindrom Še posebej previdni moramo biti pri diagnosticiranju hude kronične nevtropenije, ki je ne smemo zamenjati z drugimi boleznimi krvotvornih celic, kot so aplastična anemija, mielodisplazija in mieloična levkemija.
English: The assessment of undesirable effects is based on the following frequency data:
Slovenian: Neželeni učinki si opredeljeni po pogostosti: Zelo pogosti:
English: Filgrastim ratiopharm contains the active substance filgrastim.
Slovenian: Filgrastim ratiopharm vsebuje zdravilno učinkovino filgrastim.
English: It is quite normal to have a number of courses of Filgrastim ratiopharm treatment.
Slovenian: Povsem običajno je, da zdravljenje z zdravilom Filgrastim ratiopharm
English: If the ANC decreases to < 1.0 x 109/l during the treatment period the dose of filgrastim should be reescalated according to the above steps
Slovenian: Če se med zdravljenjem absolutno število nevtrofilcev zmanjša, tako da je vrednost < 1,0 x 109/l, je treba odmerek filgrastima povečati, kot je opisano zgoraj.
English: Filgrastim ratiopharm are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Slovenian: Zdravilo Filgrastim ratiopharm je mogoče dobiti v pakiranjih po 1, 5 ali 10 napolnjenih injekcijskih brizg ali v obliki skupnih pakiranj po 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg.
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: Tveganja, povezana s povečanimi odmerki mielosupresivnih zdravil Zaradi mielosupresivnih zdravil zdravljenje samo s filgrastimom ne zadostuje za preprečevanje trombocitopenije in anemije.
English: Long-term treatment with Filgrastim ratiopharm is required for neutropenia.
Slovenian: Pri nevtropeniji je potrebno dolgotrajno zdravljenje z zdravilom Filgrastim ratiopharm.
English: Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10% of patients.
Slovenian: Pri manj kot 10% bolnikov sta se kmalu po začetku terapije s filgrastimom pojavila glavobol in diareja.
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and
Slovenian: Infuzija matičnih celic iz periferne krvi spodbuja hematopoetično okrevanje, skrajša trajanje tveganja za hemoragične zaplete in zmanjša potrebo po transfuziji trombocitov.
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any
Slovenian: Da bi pri bolniku izmerili spodnjo mejo oz. najnižje absolutno število nevtrofilcev, se priporoča, da se vzorci krvi za meritve absolutnega števila nevtrofilcev vzamejo tik pred predpisanim odmerjanjem
English: Splenic enlargement was reported to be related to filgrastim therapy in < 3% of patients.
Slovenian: Pri < 3% bolnikov so poročali o povečanju vranice, povezanem s zdravljenjem s filgrastimom.
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 30 MIU/0.5 ml
Slovenian: PODATKI V BRAILLOVI PISAVI Filgrastim ratiopharm 30 000 k.i.e./0,5 ml
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with
Slovenian: Najnovejši podatki kažejo, da so imunološke interakcije alogenskega presadka matičnih celic iz periferne krvi in prejemnika, v primerjavi s presaditvijo kostnega mozga, lahko povezane s povečanim
English: Mobilisation
Slovenian: Zbiranje
English: Each pre-filled syringe contains 0.5 ml or 0.8 ml of
Slovenian: Ena napolnjena injekcijska brizga vsebuje 0,5 ml ali 0,8 ml raztopine.
English: Special precautions in patients undergoing peripheral blood progenitor cell mobilisation
Slovenian: Posebni previdnostni ukrepi pri bolnikih, pri katerih poteka zbiranje matičnih celic iz periferne krvi
English: Filgrastim ratiopharm 48 MIU/0.8 ml: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml solution.
Slovenian: Filgrastim ratiopharm 48 000 k.i.e./0,8 ml: ena napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) zdravila filgrastim v 0,8 ml raztopine.
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 48 MIU/0.8 ml
Slovenian: PODATKI V BRAILLOVI PISAVI Filgrastim ratiopharm 48 000 k.i.e./0,8 ml
English: If leukocyte counts exceed 50 x 10 should be discontinued immediately.
Slovenian: Če število belih krvničk po pričakovanem padcu nato preseže vrednost 50 × x 109/l, je potrebno zdravljenje s filgrastimom takoj ukiniti.
English: Filgrastim ratiopharm and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Slovenian: Zdravilo Filgrastim ratiopharm in huda kronična nevtropenija Običajni odmerek na kilogram telesne mase je od 0,5 do 1,2 milijona mednarodnih enot (i.e.) dnevno, bodisi v enkratnem ali večkratnih odmerkih.
English: Filgrastim ratiopharm and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Slovenian: Zdravilo Filgrastim ratiopharm in zbiranje matičnih celic iz periferne krvi Če darujete izvorne celice zase, potem je običajni odmerek na kilogram telesne mase 0,5 milijonov mednarodnih enot (i.e.) dnevno.
English: How do I inject Filgrastim ratiopharm myself?
Slovenian: Kako si sami vbrizgate zdravilo Filgrastim ratiopharm?
English: Rheumatoid arthritis exacerbation Severe allergic reaction
Slovenian: Občasni resne alergijske reakcije
English: Transient, moderate decreases in non-fasting blood glucose have also been
Slovenian: Opaziti je bilo tudi občasno, blago znižanje ravni glukoze v krvi.
English: Filgrastim ratiopharm and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Slovenian: Zdravilo Filgrastim ratiopharm in nevtropenija pri bolnikih, okuženih s HIV Običajni odmerek na kilogram telesne mase je od 0,1 do 0,4 milijona mednarodnih enot (i.e.) dnevno.
English: - The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water
Slovenian: - Druge sestavine so: natrijev hidroksid, ocetna kislina, koncentrirana;ledocet, sorbitol, polisorbat
English: Filgrastim ratiopharm and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Slovenian: Zdravilo Filgrastim ratiopharm in presaditev kostnega mozga Običajni odmerek na kilogram telesne mase je 1 milijon mednarodnih enot (i.e.) dnevno.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 ml solution for injection or
Slovenian: Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,5 ml raztopine za injiciranje ali infundiranje ali skupna pakiranja z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,5 ml raztopine za
English: Musculoskeletal and connective
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Slovenian: Filgrastim ratiopharm 30 000 k.i.e./0,5 ml raztopina za injiciranje ali infundiranje Filgrastim ratiopharm 48 000 k.i.e./0,8 ml raztopina za injiciranje ali infundiranje filgrastim
English: For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Slovenian: Za infundiranje je potrebno filgrastim razredčiti v 20 ml glukoze 50 mg/ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6.6).
English: Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after GCSF administration.
Slovenian: Po uporabi G-CSF so opisani redki primeri neželenih učinkov na pljučih, zlasti intersticijske pljučnice.
English: In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10%, and severe musculoskeletal pain in 3% of patients.
Slovenian: Blaga do zmerna mišičnoskeletna bolečina, ki se je pojavila pri 10% bolnikov, ter huda mišičnoskeletna bolečina, ki se je pojavila pri 3% bolnikov, sta bila najbolj pogosta neželena učinka, ki so ju v kliničnih preskušanjih pripisali filgrastimu v priporočenem odmerku.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
Slovenian: Če je zdravilo Filgrastim ratiopharm pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
English: As a very common side effect, filgrastim may cause bone and muscle pain.
Slovenian: Zelo pogost neželeni učinek zdravljenja s filgrastimom je bolečina v mišicah in kosteh.
English: Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
Slovenian: Pediatrična uporaba pri bolnikih s hudo kronično nevtropenijo in rakom 65% bolnikov, ki so sodelovali v raziskovalnem programu za bolnike s hudo kronično nevtropenijo, je bilo mlajših od 18 let.
English: If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Filgrastim ratiopharm.
Slovenian: Če imate srpasto anemijo, morate to, pred pričetkom jemanja zdravila Filgrastim ratiopharm, obvezno povedati svojemu zdravniku.
English: EU/1/08/449/007 2 x 5 pre-filled syringes
Slovenian: EU/1/08/449/005 EU/1/08/449/006 EU/1/08/449/007 EU/1/08/449/008
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 ml solution for injection or
Slovenian: Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,8 ml raztopine za injiciranje ali infundiranje ali skupno pakiranje z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,5 ml raztopine za
English: In a small number of patients (< 10%), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve
Slovenian: Pri manjšem številu bolnikov (manj od 10%) so bili za ustavitev napredovanja nevtropenije potrebni odmerki do 1,0 x 106i.e.
English: Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Slovenian: Neželeni učinek anemija, splenomegalija trombocitopenija obolenje vranice
English: EU/1/08/449/003 2 x 5 pre-filled syringes
Slovenian: EU/1/08/449/001 EU/1/08/449/002 EU/1/08/449/003 EU/1/08/449/004
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml (60 MIU/ml, 600 microgram/ml).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) zdravila filgrastim v 0,5 ml (60 000 k.i.e./ml, 600 mikrogramov /ml).
English: Medicinal product subject to medical prescription.
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed
Slovenian: Trajanje zvišane telesne temperature se pri bolnikih, ki so prejemali mieloablativno terapijo po presaditvi kostnega mozga, ni skrajšalo.
English: Then, if ANC remains > 1.0 x 109/l for 3 more
Slovenian: Če absolutno število nevtrofilcev ostane > 1,0 x
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
Slovenian: (10 μg)/kg/dan v obliki 24-urne subkutane infuzije ali enkraten dnevni odmerek v obliki subkutane injekcije v obdobju od 5-ih do 7-ih dni zapored.
English: There were no differences in the safety profiles for paediatric patients treated for severe
Slovenian: Varnostni profili bolnikov, ki so jih zdravili za hudo kronično nevtropenijo, se niso razlikovali od varnostnih profilov drugih bolnikov.
English: Regular urinanalysis should be
Slovenian: Za spremljanje teh bolezenskih stanj je potrebna redna urinska analiza.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Slovenian: Zaradi mielosupresivne kemoterapije zdravljenje samo s filgrastimom ne zadostuje za preprečevanje trombocitopenije in anemije.
English: For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell
Slovenian: Zbiranje matičnih celic iz periferne krvi pri običajnih darovalcih pred alogensko presaditvijo matičnih
English: 6.6 Special precautions for disposal and other handling If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion .
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Če je potrebno, lahko zdravilo Filgrastim ratiopharm razredčite v glukozi 50 mg/ml (5%) raztopini za Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi koncentracija padla pod 0,2 x 106 i.e. (2 μg).
English: The recommended starting dose is 0.5 MIU (5 μg)/kg/day subcutaneously as a single dose or in
Slovenian: (5 μg)/kg/dan subkutano v enkratnem odmerku ali v
English: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Slovenian: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 48 000 k.i.e./0,8 ml raztopina za injiciranje ali infundiranje
English: The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x109/l).
Slovenian: (4 μg)/kg/dan, dokler število nevtrofilcev ne doseže in ne vzdržuje na običajni ravni (absolutno število nevtrofilcev večje od 2,0 x109/l).
English: In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC
Slovenian: (300 μg)/dan od 1 do 7 dni na teden, pri čemer so bolniki v povprečju prejemali 3 odmerke na teden.
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/l.
Slovenian: Glede na absolutno število nevtrofilcev pri posameznih bolnikih bodo morda potrebne nadaljnje prilagoditve odmerkov, zato da bi bilo število nevtrofilcev večje od 2,0 x 109/l.
English: Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in normal donors receiving filgrastim; these were
Slovenian: Pri običajnih bolnikih, ki so prejemali filgrastim, so poročali o prehodnih, manj pomembnih zvišanjih alkalne fosfataze, LDH, serum glutamate oksaloacetate transaminaze (SGOT) in sečne kisline, ki pa