natgillin/translations-raw huggingface dataset:
Therefore, the CHMP’ s view was that, as for Neupogen, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da so koristi zdravila Biograstim, tako kot pri zdravilu Neupogen, večje od znanih tveganj.
Strength 30 MIU (300 µg/ 0.5 ml)
30 MIU (300 µg/ 0, 5 ml)
Pharmaceutical Form Solution for injection or infusion
Raztopina za injiciranje ali infundiranje
Route of Administration Subcutaneous or intravenous use
Subkutano ali intravenozno
Packaging pre-filled syringe (glass)
Napolnjena injekcijska brizga (steklena)
Package size 1 pre-filled syringe
1 napolnjena injekcijska brizga
30 MIU (300 µg/ 0.5 ml)
30 MIU (300 µg/ 0, 5 ml)
pre-filled syringe (glass)
Napolnjena injekcijska brizga (steklena)
2 x 5 pre-filled syringes
2x5 napolnjenih injekcijskih brizg
48 MIU (480 µg/ 0.8 ml)
48 MIU (480 µg/ 0, 8 ml)
Biograstim 30 MIU/ 0.5 ml solution for injection or infusion
Biograstim 30 000 k. i. e. / 0, 5 ml raztopina za injiciranje ali infundiranje
Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
1ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov mednarodnih enot [i. e.] (600 µg) filgrastima.
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 ml solution for injection or infusion.
(300 µg) filgrastima v 0, 5 ml raztopine za injiciranje ali infundiranje.
Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Filgrastim (rekombinantni metionil- granulocitne kolonije stimulirajoči faktor, humani) pridobljen s pomočjo rekombinantne DNK tehnologije v Escherichia coli K802.
Each ml of solution contains 50 mg of sorbitol.
1ml raztopine vsebuje 50 mg sorbitola.
Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Zdravilo Biograstim se uporablja za skrajšanje trajanja nevtropenije in v primeru nastanka febrilne nevtropenije pri bolnikih, ki prejemajo citotoksično kemoterapijo za maligne tvorbe (z izjemo kronične mieloične levkemije in mielodisplastičnih sindromov), ter za skrajšanje trajanja nevtropenije pri bolnikih, ki se zdravijo z mieloablativno terapijo po presaditvi kostnega mozga, pri katerih obstaja povečano tveganje za dlje trajajočo hudo nevtropenijo.
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Bolnikom, otrokom ali odraslim s hujšo obliko kongenitalne, ciklične ali idiopatične nevtropenije z absolutnim številom nevtrofilcev (ANC) 0, 5 × 109/ l in s hujšimi ali ponavljajočimi se okužbami, se dolgotrajno jemanje zdravila Biograstim predpiše zato, da se poveča število nevtrofilcev in zmanjša pogostost nastanka in trajanja z okužbami povezanih pojavov.
Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Zdravilo Biograstim se uporablja za zdravljenje dolgotrajne nevtropenije (ANC manjše ali enako 1, 0 × 109/ l) pri bolnikih z napredovalo okužbo HIV, z namenom zmanjšanja tveganja bakterijskih okužb, ko druge oblike zdravljenja nevtropenije niso primerne.
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.
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.
The mobilisation and apheresis procedures should be performed in
Postopek zbiranja in afereze bi
2 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
2 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.
The recommended dose of filgrastim is 0.5 MIU (5 μ g)/ kg/ day.
(5 μg) / kg/ dan.
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).
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).
The choice of route should depend on the individual clinical circumstance.
V randomiziranih kliničnih preskušanjih so uporabljali subkutani odmerek 23 x 106i. e.
In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μ g)/ m2/ day (4.0 to 8.4 μ g/ kg/ day) was used.
(230 μg) / m2/ dan (4, 0 do 8, 4 μg/ kg/ dan).
The recommended starting dose of filgrastim is 1.0 MIU (10 μ g)/ kg/ day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μ g)/ kg/ day given by continuous 24 hour subcutaneous infusion.
(10 μg) / kg/ dan v obliki neprekinjene 24- urne subkutane infuzije.
Filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Filgrastim je potrebno razredčiti v 20 ml glukoze 50 mg/ ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6. 6).
The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
Bolnik lahko prvi odmerek filgrastima prejme šele 24 ur po citotoksični kemoterapiji, v primeru presaditve kostnega mozga pa mora odmerek prejeti v roku 24- ih ur.
Neutrophil count > 1.0 x 109/ l for 3 consecutive days Then, if ANC remains > 1.0 x 109/ l for 3 more consecutive days
Število nevtrofilcev > 1, 0 x 109/ l 3 zaporedne dni Če absolutno število nevtrofilcev ostane > 1, 0 x 109/ l tri zaporedne dni
Filgrastim dose adjustment Reduce to 0.5 MIU (5 µg)/ kg/ day Discontinue filgrastim
(5 µg) / kg/ dan Prekinite zdravljenja s filgrastimom
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 odmerek filgrastima povečati, kot je opisano zgoraj.
The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μ g)/ kg/ day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
(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.
1 or
Za infundiranje je potrebno filgrastim razredčiti v 20 ml glukoze 50 mg/ ml (5%) raztopini za infundiranje (postopek redčenja je 3 opisan v poglavju 6. 6).
3 2 leukaphereses on days 5 and 6 are often sufficient.
Časovna razporeditev levkaferez: običajno zadostujeta 1 do 2 levkafrezi 5. in 6. dan.
The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μ g)/ kg/ day given daily by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Priporočen odmerek filgrastima za zbiranje matičnih celic iz periferne krvi po mielosupresivni kemoterapiji je 0, 5 x 106i. e.
Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
(5 μg) / kg/ dan v obliki subkutane injekcije od prvega dne po koncu kemoterapije, pa dokler pričakovani padec števila nevtrofilcev ne preide na višji nivo in se število nevtrofilcev ne povrne na običajno raven.
For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μ g)/ kg/ day subcutaneously for 4 to 5 consecutive days.
(10 μg) / kg/ dan v subkutani obliki.
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.
Z levkaferezo je potrebno pričeti 5. dan, če je potrebno, pa z njo nadaljujte tudi 6. dan, da bi zbrali 4 x 106 CD34+ celic/ kg telesne teže prejemnika.
Congenital neutropenia The recommended starting dose is 1.2 MIU (12 μ g)/ kg/ day subcutaneously as a single dose or in divided doses.
(12 μg) / kg/ dan subkutano v enkratnem odmerku ali v večkratnih odmerkih.
Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MIU (5 μ g)/ kg/ day subcutaneously as a single dose or in divided doses.
(5 μg) / kg/ dan subkutano v enkratnem odmerku ali v večkratnih odmerkih.
Dose adjustment Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/ l.
Prilagoditev odmerka Filgrastim je potrebno odmerjati dnevno v obliki subkutanih injekcij, dokler število nevtrofilcev ne doseže in ostane večje od 1, 5 x 109/ l.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Po eno - ali dvotedenskem zdravljenju se začetni odmerek lahko podvoji ali prepolovi, odvisno od odziva bolnika.
Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/ l and 10 x 109/ l.
Za to, da bi povprečno število nevtrofilcev ostalo med 1, 5 x 109/ l in 10 x 109/ l, se odmerek lahko prilagaja glede na posameznika vsak teden oz. vsaka dva tedna.
A faster schedule of dose escalation may be considered in patients presenting with severe infections.
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.
In clinical trials, 97% of patients who responded had a complete response at doses of 2.4 MIU (24 μ g)/ kg/ day.
Dolgoročna varnost odmerjanja filgrastima v odmerkih, večjih od 2, 4 x 106i. e.
The long-term safety of filgrastim administration above 2.4 MIU (24 μ g)/ kg/ day in patients with SCN has not been established.
(24 μg) / kg/ dan, bolnikom s hudo kronično nevtropenijo, ni bila ugotovljena.
For reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MIU (1 μ g)/ kg/ day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μ g)/ kg/ day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x109/ l).
(4 μg) / kg/ dan, dokler število nevtrofilcev ne doseže in ne vzdržuje na običajni ravni (absolutno število nevtrofilcev večje od 2, 0 x109/ l).
In a small number of patients (< 10%), doses up to 1.0 MIU (10 μ g)/ kg/ day were required to achieve reversal of neutropenia.
(10 μg) / kg/ dan.
For maintaining normal neutrophil counts When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Priporoča se prilagoditev dnevnega odmerka v
Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.
(300 μg) / dan v obliki subkutane injekcije.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
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.
In clinical studies, dosing with 30 MIU (300 μ g)/ day on 1 to 7 days per week was required to maintain the ANC
V kliničnih preskušanjih je bilo za to, da bi bilo absolutno število nevtrofilcev večje od 2, 0 x 109/ l, potrebno odmerjati 30 x 106i. e.
4 > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
(300 μg) / dan od 1 do 7 dni na teden, pri čemer so bolniki v povprečju prejemali 3 odmerke na teden.
Long-term administration may be required to maintain the ANC > 2.0 x 109/ l.
Za to, da bi bilo absolutno število nevtrofilcev večje od 2, 0 x 109/ l, bo morda potrebno dolgotrajno zdravljenje.
Elderly patients Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Starejši bolniki V kliničnih preskušanjih s filgrastimom je sodelovalo tudi manjše število starejših bolnikov, vendar posebnih raziskav v tej skupini niso izvajali, zato priporočenih odmerkov ne moremo navesti.
Patients with renal or hepatic impairment Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Bolniki z ledvično ali jetrno okvaro Raziskave v zvezi z učinkom filgrastima na bolnike s hudo okvaro ledvic ali jeter so pokazale, da ima zdravilo na te bolnike podoben farmakokinetičen in farmakodinamičen učinek kot na običajne posameznike.
Paediatric use in the SCN and cancer settings Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
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.
Malignant cell growth 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.
Rast malignih celic 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.
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.
5 Varnost in učinkovitost filgrastima pri bolnikih z de novo AML, mlajših od 55 let in z ugodno citogenetiko [t( 8; 21), t( 15; 17) in inv( 16)], nista ugotovljeni.
5 Other special precautions 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.
Drugi posebni previdnostni ukrepi Bolnikom z osteoporozo, ki neprekinjeno prejemajo filgrastim dlje kot 6 mesecev, je potrebno meriti kostno gostoto.
Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after G- CSF administration.
Po uporabi G- CSF so opisani redki primeri neželenih učinkov na pljučih, zlasti intersticijske pljučnice.
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).
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 ’).
Leukocytosis White blood cell counts of 100 x 109/ l or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/ kg/ day (3 μ g/ kg/ day).
Levkocitoza Pri manj kot 5% bolnikov, ki prejemajo filgrastim v odmerku, večjem od 0, 3 x 106i. e. / kg/ dan (3 μg/ kg/ dan), so opazili število belih krvničk, ki je enako ali večje od 100 × 109/ l.
If leukocyte counts exceed 50 x 109/ l after the expected nadir, filgrastim should be discontinued immediately.
Če število belih krvničk po pričakovanem padcu nato preseže vrednost 50 × x 109/ l, je potrebno zdravljenje s filgrastimom takoj ukiniti.
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.
Če bolniku prejema filgrastim za zbiranje matičnih celic v periferni krvi, je potrebno zdravljenje s filgrastimom prenehati ali pa, v primeru da število levkocitov preseže vrednost 70 x 109/ l, zmanjšati odmerek.
Risks associated with increased doses of chemotherapy 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).
Tveganja, povezana z zvečanimi odmerki kemoterapije Še posebej pozorni moramo biti pri zdravljenju bolnikov z visokimi odmerki kemoterapije, ker pozitivni učinki kemoterapije na rast tumorja še niso vidni, saj lahko zvečani odmerki kemoterapevtskih učinkovin povzročijo povečano toksičnost, le- ta pa vpliva na srce, pljuča, živčevje in kožo (obrnite se na Povzetek glavnih značilnosti zdravila posameznih kemoterapevtskih učinkovin).
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.
Ker obstaja možnost, da bi moral bolnik prejemati višje odmerke kemoterapije (npr. visoke odmerke glede na predpisano shemo), je bolnik lahko bolj izpostavljen tveganju za trombocitopenijo in anemijo.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Drugi posebni previdnostni ukrepi Učinki filgrastima na bolnike z znatno zmanjšanim številom matičnih celic mieloične vrste niso bili raziskani.
The effect of filgrastim on graft versus host disease has not been defined.
Učinek filgrastima na reakcijo presadka proti gostitelju še ni bil določen.
This should be considered when interpreting bone-imaging results.
Povečano hematopoetsko aktivnost kostnega mozga, ki se je pojavila zaradi zdravljenja z rastnim faktorjem, so povezali z ugotovitvami o prehodnem pozitivnem obarvanju kosti, kar je potrebno upoštevati pri interpretaciji izidov obarvanja kosti.
6 population.
6 Zbiranje Na voljo še ni naključnih primerjav obeh priporočenih metod zbiranja (metodo filgrastim samo ali v kombinaciji z mielosupresivno kemoterapijo) v okviru ene skupine bolnikov.
Prior exposure to cytotoxic agents Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 106 CD34+ cells/ kg) or acceleration of platelet recovery to the same degree.
Predhodno izpostavljanje citotoksičnim učinkovinam Pri bolniki, ki so bili predhodno izpostavljeni dolgotrajni mielosupresivni terapiji, se lahko zgodi, da ni bilo zbranih dovolj matičnih celic iz periferne krvi, da bi dosegli njihovo minimalno število (2, 0 x 106 CD34+ celic/ kg) ali pospešeno tvorjenje trombocitov v enaki meri.
Assessment of progenitor cell yields In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Ocena števila matičnih celic Pri ocenjevanju pridobljenih matičnih celic pri bolnikih, ki so prejemali filgrastim, je treba posebej paziti na metodo za ugotavljanje količinske sestave.
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.
Statistična analiza odnosa med številom ponovno infundiranih celic CD34+ in hitrostjo obnovitve trombocitov po visoko- odmerni kemoterapiji kaže na zapleteno ampak stalno povezavo.
The recommendation of a minimum yield of 2.0 x 106 CD34+ cells/ kg is based on published experience resulting in adequate haematologic reconstitution.
Priporočilo o minimalnem številu 2, 0 x 106 CD34+ celic/ kg temelji na objavljenih izkušnjah, ki so prispevale k ustrezni hematološki sliki.
The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Varnost in učinkovitost zdravila filgrastim pri običajnih darovalcih, mlajših od 16 let ali starejših od 60. let, nista bili ocenjeni.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Pri 35% oseb, ki so sodelovale v preskušanju, so po odmerjanju filgrastima in po levkaferezi opazili prehodno trombocitopenijo (št. trombocitov < 100 x 109/ l).
Among these, two cases of platelets < 50 x 109/ l were reported and attributed to the leukapheresis procedure.
Med njimi so poročali o dveh primerih, pri katerih je bilo število trombocitov < 50 x 109/ l, kar so pripisali postopku levkafereze.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/ l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/ l.
Če je potrebna več kot ena levkafereza, je potrebno pred samim postopkom levkafereze posebno pozornost nameniti bolnikom, katerih število trombocitov je < 100 x 109/ l; v splošnem levkafereze ne smemo izvesti, če je število trombocitov < 75 x 109/ l.
Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
7 Levkafereze ne smemo izvajati pri darovalcih, ki prejemajo zdravila proti strjevanju krvi ali imajo motnje hemostaze.
7 Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/ l.
Če se število belih krvničk zveča, tako da je > 70 x109/ l, je potrebno zdravljenje s filgrastimom prekiniti ali pa zmanjšati odmerek.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Darovalce, ki za zbiranje matičnih celic iz periferne krvi prejemajo faktor, ki spodbuja rast granulocitnih kolonij (G- CSF), je potrebno spremljati, dokler ne dobimo normalne hematološka slike.
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Zaradi tega moramo velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
A diagnosis of splenic rupture should be considered in donors and/ or patients reporting left upper abdominal pain or shoulder tip pain.
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.
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 graft versus host disease when compared with bone marrow transplantation.
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 tveganjem akutne in kronične reakcije presadka proti gostitelju.
Blood cell counts Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Število krvnih celic Pozorno je treba spremljati število trombocitov, še posebej prvih nekaj tednov zdravljenja s filgrastimom.