natgillin/translations-raw huggingface dataset:
However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Kadar filgrastim dajemo za izplavljanje krvotvornih matičnih celic v periferno kri, je treba prenehati z dajanjem filgrastima oziroma zmanjšati njegov odmerek, če se število levkocitov poveča na > 70 x 109/l.
A subset of approximately 12 % of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
bolnikov, ki so imeli na začetku normalen citogenetski izvid, so pri poznejšem ponovnem rutinskem pregledu ugotovili nepravilnosti, vključno z monosomijo 7.
- 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 an enlarged spleen (splenomegaly), or possibly rupture ofthe spleen).
- imate bolečine v zgornjem levem delu trebuha, bolečine pod levo stranjo prsnega koša ali na vrhu leve rame (to so lahko simptomi povečane vranice (splenomegalija) ali možnega pretrganja vranice).
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ratiograstim
Razen če vam zdravnik ne naroči drugače, morate med uporabo zdravila Ratiograstim prenehati z dojenjem.
Filgrastim is not recommended during pregnancy..Breast-feeding It is unknown whether filgrastim/metabolites are excreted in human breast milk.
Dojenje Ni znano, ali se filgrastim/presnovki izločajo v materino mleko.
Ratiograstim may have a minor influence on your ability to drive and use machines.
Zdravilo Ratiograstim ima lahko blag vpliv na sposobnost upravljanja vozil in strojev.
How do I prepare my Ratiograstim injection?
Kako si pripravim z zdravilom Ratiograstim napolnjeno injekcijo?
Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe and alcohol wipes).
Poiščite si udoben, dobro osvetljen prostor in si pripravite vse, kar boste potrebovali, tako da bo pri roki (z zdravilom Ratiograstim napolnjeno injekcijsko brizgo in alkoholne krpice).
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea
Povedati morate tudi, če vaš otrok ne more več uživati sladke hrane ali pijače, ker mu je po njej slabo, bruha ali ima težave, kot so napihnjenost, želodčni krči ali driska.
What Ratiograstim is and what it is used for What Ratiograstim is
Kaj je zdravilo Ratiograstim in za kaj ga uporabljamo Kaj je zdravilo Ratiograstim
ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Da bi ugotovili bolnikovo najnižjo vrednost ANC, je priporočljivo odvzeti krvne vzorce za merjenje ANC tik pred načrtovanim odmerkom filgrastima.
Myelodysplastic syndrome or Chronic myeloid leukemia
Mielodisplastični sindrom ali kronična mieloična levkemija
The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Priporočeni odmerek filgrastima je 0,5 milijona i.e. (5 μg)/kg/dan.
Ratiograstim works by encouraging the bone marrow to produce more white blood cells.
Zdravilo Ratiograstim deluje tako, da spodbuja kostni mozeg, da proizvaja več belih krvničk.
Ratiograstim contains sorbitol
Zdravilo Ratiograstim vsebuje sorbitol
If the ANC decreases to < 1.0 x 109/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps
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.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the Summary of Product Characteristics of the specific chemotherapy agents used).
Posebna previdnost je potrebna tudi pri zdravljenju bolnikov, ki prejemajo kemoterapijo v velikih odmerkih, ker ni bil dokazan boljši izid, kar zadeva tumorje in lahko večji odmerki kemoterapevtikov vodijo do povečane toksičnosti, vključno s srčnimi, pljučnimi, nevrološkimi in dermatološkimi učinki
- to increase the number of white blood cells after a bone marrow transplant to help prevent infections.
- za povečanje števila belih krvničk po presaditvi kostnega mozga, kot pomoč pri preprečevanju okužb;
Ratiograstim 30 MIU/0.5 mL
Ratiograstim 30 M i.e./0.5 ml
It is advisable to wait and see how you feel after using this medicine and before driving or operating machinery.
Pred vožnjo avtomobila ali upravljanjem strojev je priporočljivo počakati, da vidite, kako se počutite po tem, ko uporabite zdravilo Ratiograstim.
Check the expiry date on the pre-filled syringe label (EXP).
Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjene injekcijske brizge
In patients with known bone marrow-infiltrating infections or malignancy, consider appropriate therapy for treatment of the underlying condition in addition to administration of filgrastim for treatment of neutropenia.
Pri bolnikih z znano infiltracijo okužbe ali malignim obolenjem kostnega mozga je treba, poleg dajanja filgrastima za zdravljenje nevtropenije, razmisliti o uvedbi primernega zdravljenja za osnovno bolezen.
How to use Ratiograstim
Kako uporabljati zdravilo Ratiograstim
The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day.
Priporočeni začetni odmerek filgrastima je 1,0 milijon i.e. (10 μg)/kg/dan.
Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution for infusion given over 30 minutes (see section 6.6).
Filgrastim lahko dajemo dnevno v obliki subkutane injekcije ali v obliki 30-minutne intravenske infuzije zdravila, razredčenega z raztopino glukoze 50 mg/ml (5 %) za infundiranje (glejte poglavje 6.6).
Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
Poiščite si udoben, dobro osvetljen prostor in si pripravite vse, kar boste potrebovali, tako da bo pri roki (z zdravilom Ratiograstim napolnjeno injekcijsko brizgo, alkoholne krpice in vsebnik, odporen na vbode).
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.
Primer: V injekciji s končnim volumnom 20 ml, morate k celotnemu odmerku filgrastima z manj kot 30 milijonov i.e. (300 μg) dodati 0,2 ml 20 % raztopine humanega albumina.
Ratiograstim has not been tested in pregnant or breast-feeding women.
Uporabe zdravila Ratiograstim pri nosečnicah in doječih ženskah niso preskušali.
Initial dose adjustment to alternate day dosing with 30 MIU (300 μg)/day is recommended.
Priporoča se prilagoditev dnevnega odmerka v vrednosti 30 milijonov i.e. (300 μg)/dan.
In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 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.
V kliničnih preskušanjih je bilo za to, da bi bilo absolutno število nevtrofilcev večje od 2,0 x 109/l, potrebno odmerjati 30 milijonov i.e. (300 μg)/dan od 1 do 7 dni na teden, pri čemer so bolniki v povprečju prejemali 3 odmerke na teden.
Ratiograstim stimulates the bone marrow to produce new white cells quickly.
Zdravilo Ratiograstim spodbuja kostni mozeg k hitremu proizvajanju novih belih krvničk.
Contents of the pack and other information Information for injecting yourself
Shranjevanje zdravila Ratiograstim Vsebina pakiranja in dodatne informacije Informacije za injiciranje zdravila Naslednje informacije so namenjene samo zdravstvenemu osebju
Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure.
< 50 x 109/l, ki so ju pripisali izvedbi postopka levkafereze.
Each mL of solution for injection/infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
1 ml raztopine za injiciranje/infundiranje vsebuje 60 milijonov mednarodnih enot [i.e.] (600 µg) filgrastima.
In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
(230 μg)/m2/dan (4,0 do 8,4 μg/kg/dan).
How do I inject Ratiograstim myself?
Kako si sami vbrizgate zdravilo Ratiograstim?
Excipient with known effect Each mL of solution contains 50 mg of sorbitol.
1 ml raztopine vsebuje 50 mg sorbitola.
See also section 4.8.
G-CSF (glejte tudi poglavje 4.8).
notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).
- opazite neobičajno krvavitev ali modrice (to so lahko simptomi zmanjšanja števila trombocitov
Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy: Filgrastim should be given by subcutaneous injection.
Filgrastim za izplavljanje matičnih celic iz periferne krvi po mielosupresivni kemoterapiji: Filgrastim je treba dajati v obliki subkutane injekcije.
Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Pri bolnikih z osteoporotičnimi obolenji kosti, ki se neprekinjeno zdravijo s filgrastimom dlje kot
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Wrapper Label on Multipacks- With Blue Box
PODATKI NA ZUNANJI OVOJNINI Nalepka na zunanji ovojnini skupnih pakiranj s podatki »Blue Box«
Method of administration Filgrastim should be given by subcutaneous injection.
Način uporabe Filgrastim je treba dajati v obliki subkutane injekcije.
• changes in blood chemistry
• spremembe v kemijski sestavi krvi • transfuzijska reakcija
Name and address of the manufacturer of the biological active substance SICOR Biotech UAB
Ime in naslov izdelovalca biološke zdravilne učinkovine
Ratiograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Ratiograstim 30 milijonov i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) filgrastima v 0,5 ml raztopine.
- The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
- Druge sestavine zdravila so: natrijev hidroksid, ocetna kislina, koncentrirana; ledocet, sorbitol, polisorbat 80, voda za injekcije.
PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious disease.
Izplavljanje matičnih celic v periferno kri se sme uporabiti le pri tistih darovalcih, ki ustrezajo normalnim kliničnim in laboratorijskim kriterijem primernosti za darovanje matičnih celic.
Ratiograstim 48 MIU/0.8 mL: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL solution.
Ratiograstim 48 milijonov i.e./0,8 ml: ena napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) filgrastima v 0,8 ml raztopine.
Filgrastim should be diluted in 20 mL of 5% glucose solution for infusion (see section 6.6).
Filgrastim je treba razredčiti z 20 ml raztopine 50 mg/ml (5 %) glukoze za infundiranje (glejte poglavje 6.6).
UAB "Sicor Biotech" filiāle Latvijā
SICOR Biotech UAB
Solution for injection/infusion Clear, colourless solution.
raztopina za injiciranje/infundiranje Bistra, brezbarvna raztopina.
EU/1/08/444/007 2 x 5 pre-filled syringes
EU/1/08/444/007 2 x 5 napolnjenih injekcijskih brizg
ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Število krvnih celic Skrbno je treba spremljati absolutno število nevtrofilcev (ANC), še posebej v prvih nekaj tednih zdravljenja s filgrastimom.
For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Izplavljanje PBPC pri zdravih darovalcih pred alogensko presaditvijo matičnih celic iz periferne krvi
Sepsis Bronchitis Upper respiratory tract infection Urinary tract infection
Infekcijske in parazitske bolezni sepsa bronhitis okužba zgornjih dihal okužba sečil
In patients treated with myeloablative therapy followed by bone marrow transplantation
Bolniki, zdravljeni z mieloablativno terapijo po presaditvi kostnega mozga Odmerjanje
The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Bolnik lahko prvi odmerek filgrastima prejme najmanj 24 ur po citotoksični kemoterapiji.
For infusions, filgrastim should be diluted in 20 mL of 5% glucose solution for infusion (see section 6.6).
Za infundiranje je treba filgrastim razredčiti z 20 ml raztopine 50 mg/ml (5 %) glukoze za infundiranje (glejte poglavje 6.6).
EU/1/08/444/003 2 x 5 pre-filled syringes
EU/1/08/444/003 2 x 5 napolnjenih injekcijskih brizg
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Pri bolnikih, ki so bili zdravljeni s filgrastimom, so poročali o preobčutljivosti, vključno z anfilaktičnimi reakcijami, ki se pojavijo med začetnim ali nadaljnjim zdravljenjem.
Because of the potential of receiving higher doses of chemotherapy (e.g., full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
polnih odmerkov po predpisani shemi), je lahko bolnik bolj ogrožen zaradi trombocitopenije in anemije.
Talk to your doctor immediately during treatment with Ratiograstim, if you: - have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
- se vam pojavijo nenadni znaki alergije, kot so izpuščaj, srbečica ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
Take special care with other products that stimulate white blood cells
Bodite posebej previdni pri drugih zdravilih, ki spodbujajo bele krvničke Zdravilo Ratiograstim sodi v skupino zdravil, ki spodbujajo nastanek belih krvničk.
Complete blood cell counts with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Pred zdravljenjem je treba opraviti preiskavo celotne krvne slike z diferencialno krvno sliko in številom trombocitov ter ovrednotiti morfologijo kostnega mozga in kariotipa.
Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Pri bolnikih, ki so prejemali visoke odmerke kemoterapije, ki jim je sledila presaditev, so občasno poročali o žilnih boleznih, vključno z venookluzivno boleznijo in motnjami volumna tekočin.
Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
Prezgodnja prekinitev zdravljenja s filgrastimom, preden število nevtrofilcev pade na pričakovano najnižjo raven,
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection/infusion.
Ena napolnjena injekcijska brizga vsebuje 30 milijonov i.e. (300 µg) filgrastima v 0,5 ml raztopine za injiciranje/infundiranje.
If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Če ste bolnik s hudo kronično nevtropenijo, lahko pri vas obstaja tveganje za nastanek krvnega raka
Haematuria was common andproteinuria occurred in a small number of patients.
Pri majhnem številu bolnikov je bila pogosta hematurija in pojavila se je proteinurija.
Common (≥ 1/100 to
(> 1/1.000 do
Inflammation of aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
- Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
The use of filgrastim mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Ugotovljeno je bilo, da krvotvorne matične celice, ki so bile izplavljene s filgrastimom, zmanjšajo stopnjo in trajanje trombocitopenije po mielosupresivni ali mieloablativni kemoterapiji.
Ratiograstim contains sodium
Zdravilo Ratiograstim vsebuje natrij
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection/infusion.
Ena napolnjena injekcijska brizga vsebuje 48 milijonov i.e. (480 µg) filgrastima v 0,8 ml raztopine za injiciranje/infundiranje.
Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Pri zdravih darovalcih so po uporabi G-CSF opazili prehodno nenormalen citogenski izvid.
• are pregnant or breast-feeding
• ste noseči ali dojite,
Uncommon (may affect up to 1 in 100 people): • increase in white blood cells (leukocytosis)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • zmanjšanje števila trombocitov, kar zmanjša sposobnost strjevanja krvi (trombocitopenija)
Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
raztopina za injiciranje/infundiranje Skupno pakiranje:10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience.
V kliničnih študijah in v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah, vključno z anafilakso, izpuščajem, urtikarijo, angioedemom, dispnejo in hipotenzijo, ki so se pojavile na začetku ali v nadaljevanju zdravljenja.
Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
raztopina za injiciranje/infundiranje Skupno pakiranje:10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
For reversal of neutropenia
Zaustavitev napredovanja nevtropenije
Solution for injection/infusion
raztopina za injiciranje/infundiranje.
In clinical studies, > 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
bolnikov odzvalo na te odmerke, tako da so za ustavitev napredovanja nevtropenije v povprečju potrebovali 2 dni.
Geriatric Use
Subkutana uporaba
For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Pri bolnikih, ki niso bili izpostavljeni dolgotrajni kemoterapiji,
The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
sindrom kapilarne prepustnosti, hudo splenomegalijo/rupturo vranice, preobrazbo v mielodisplastični sindrom ali levkemijo pri bolnikih s SCN, GvHD pri bolnikih z alogensko presaditvijo kostnega mozga ali krvotvornih matičnih celic v periferno kri ter srpastocelično krizo pri bolnikih s srpastocelično anemijo.
Solution for injection/infusion 5 pre-filled syringes containing 0.5 mL.
raztopina za injiciranje/infundiranje 5 napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
• decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
• zmanjšan občutek občutljivosti, zlasti na dotik (hipestezija) • mravljinčenje ali odrevenelost dlani ali stopal (parestezija)
Ratiograstim 30 MIU/0.5 mL solution for injection/ infusion Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
Ratiograstim 30 milijonov i.e./0,5 ml raztopina za injiciranje/infundiranje Ratiograstim 48 milijonov i.e./0,8 ml raztopina za injiciranje/infundiranje
Box for the prescribed dose
Uporabljajte v skladu s spodnjimi navodili: Škatla za predpisani odmerek
Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL (60 MIU/mL, 600 microgram/mL).
Ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) filgrastima v 0,5 ml (60 M i.e./ml, 600 mikrogramov/ml).
Solution for injection/infusion 5 pre-filled syringes containing 0.8 mL.
raztopina za injiciranje/infundiranje 5 napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
Based on reported data for another filgrastim product similar to the reference product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Na osnovi podatkov za drugo zdravilo, ki vsebuje filgrastim in je podobno referenčnem zdravilu, so primerljive ugotovitve ter zvečano število malformacij ploda opazili pri 100 µg/kg/dan, pri odmerku,
Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Po uporabi G-CSF so poročali o neželenih učinkih na pljučih, še posebno o intersticijski bolezni pljuč.
Ratiograstim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Zdravilo Ratiograstim je na voljo v pakiranjih po 1, 5 ali 10 napolnjenih injekcijskih brizg ali v obliki skupnih pakiranj po 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg.
Paediatric use in the SCN and cancer settings
Pediatrična uporaba pri bolnikih s hudo kronično nevtropenijo in rakom
Do not use any Ratiograstim that is left in the syringe.
Zdravila Ratiograstim, ki morebiti ostane v injekcijski brizgi, ne smete več uporabiti.
Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Filgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic.
Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
Vsaka napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) zdravila filgrastim v 0,8 ml (60 M i.e./ml, 600 mikrogramov/ml).
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion Filgrastim
Ratiograstim 30 M i.e./0,5 ml raztopina za injiciranje/infundiranje filgrastim
The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Bolnik lahko prvi odmerek filgrastima prejme po najmanj 24 urah po citotoksični kemoterapiji oziroma po najmanj 24 urah v primeru presaditve kostnega mozga.
However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Poročali niso o nobenih neželenih učinkih, ki bi jih lahko neposredno pripisali tej stopnji levkocitoze, vendar je treba glede na potencialno tveganje, povezano s pojavom hude levkocitoze, pri teh bolnikih med zdravljenjem s filgrastimom redno določati število belih krvničk.