natgillin/translations-raw huggingface dataset:
Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i. e. platelets consistently < 100,000/ mm3.
Pri bolnikih, pri katerih pride do trombocitopenije, kar pomeni, da je število trombocitov stalno < 100. 000/ mm3, je potrebno razmisliti o začasni prekinitvi zdravljenja ali o zmanjšanju odmerka filgrastima.
If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing filgrastim should be carefully weighed; filgrastim should be discontinued if MDS or leukaemia occur.
Če se pri bolnikih s hudo kronično nevtropenijo razvijejo citogenetske nepravilnosti, je potrebno dobro razmisliti o tveganjih in koristih nadaljnjega zdravljenja s filgrastimom; če se pojavita
Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Drugi posebni previdnostni ukrepi Potrebno je izključiti vzroke prehodne nevtropenije, kot so npr. virusne okužbe.
Increases in volume, measured
Pri enaintridesetih odstotkih (31%) bolnikov, ki so sodelovali v raziskavah, so zabeležili otipljivo splenomegalijo.
8 radiographically, occurred early during filgrastim therapy and tended to plateau.
Povečanje, zmerjeno z radiografijo, se je pojavilo v zgodnji fazi zdravljenja s filgrastimom, nato pa se je umirilo.
Haematuria/ proteinuria occurred in a small number of patients.
Pri manjšem številu bolnikov se je pojavila hematurija/ proteinurija.
Blood cell counts ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Število krvnih celic Pozorno je treba spremljati absolutno število nevtrofilcev, še posebej prvih nekaj tednov zdravljenja s filgrastimom.
During intermittent dosing with 30 MIU (300 μ g)/ day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
(300 μg) / dan, so čez čas lahko opazna velika nihanja v absolutnem številu nevtrofilcev.
Biograstim contains sorbitol.
9 Zdravilo Biograstim vsebuje sorbitol.
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Predhodni podatki, pridobljeni na podlagi opazovanj manjšega števila bolnikov, kažejo, da sočasna uporaba zdravila filgrastim in 5- Fluorouracila okrepi nevtropenijo.
9 Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Možnih interakcij z drugimi hemotopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso posebej raziskali.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5. 3).
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with filgrastim should be made taking into account the benefit of breast- feeding to the child and the benefit of filgrastim therapy to the woman.
Odločitev o tem, ali naj mati nadaljuje/ prekine z dojenjem ali naj nadaljuje/ prekine zdravljenje s filgrastimom, je treba sprejeti glede na to, kakšne koristi ima dojenje za otroka oz. zdravljenje s filgrastimom za mater.
The assessment of undesirable effects is based on the following frequency data:
Neželeni učinki so opredeljeni po pogostnosti:
≥ 1/ 10 ≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000, < 1/ 100 ≥ 1/ 10,000, < 1/ 1,000 < 1/ 10,000 cannot be estimated from the available data
≥1/ 10 ≥1/ 100, < 1/ 10 ≥1/ 1. 000, < 1/ 100 ≥1/ 10. 000, < 1/ 1, 000 < 1/ 10. 000 iz razpoložljivih podatkov pogostnosti ni mogoče oceniti
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.
10 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.
Undesirable effects reported with equal frequency in patients treated with filgrastim/ chemotherapy and placebo/ chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Med neželenimi učinki, o katerih so enako pogosto poročali bolniki, zdravljeni s filgrastimom/ kemoterapijo in placebom/ kemoterapijo, so bili slabost in bruhanje, alopecija, diareja, utrujenost, anoreksija, vnetje sluznice, glavobol, kašelj, izpuščaj na koži, bolečina v prsih, splošna oslabelost, vneto grlo, zaprtje in nespecifična bolečina.
10 Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Reverzibilno, od odmerka odvisno blago do zmerno zvišanje laktatne dehidrogenaze (LDH), alkalne fosfataze, sečne kisline in gama- glutamiltransferaze (GGT) se je pojavilo pri 50%, 35%, 25% in 10% bolnikov, ki so prejemali filgrastim v priporočenem odmerku.
Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
V nekaterih opisanih primerih je prišlo do respiracijske insuficience ali sindroma dihalne stiske pri odraslih (ARDS), ki sta lahko usodna (glejte poglavje 4. 4).
Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment, have been reported in patients receiving filgrastim.
Alergijske reakcije: pri bolnikih, ki so prejemali filgrastim, so poročali o alergijskih reakcijah, vključno z anafilaksijo, izpuščajem na koži, urtikarijo, angioedemom, dispnejo in hipotenzijo, ki so se pojavile na začetku ali v nadaljevanju zdravljenja.
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje 4. 4).
System organ class Metabolism and nutrition disorders
Neželeni učinek Organski sistem
Frequency Very common
Zelo pogosti
Undesirable effect Elevated alkaline phosphatase, elevated LDH, elevated uric acid
Zvišanje alkalne fosfataze, laktatne dehidrogenaze (LDH), sečne kisline
Nervous system disorders Vascular disorders Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Bolezni živčevja Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Common Rare Common Very rare Very common Common
Pogosti Redki Pogosti Zelo redki Zelo pogosti Pogosti
Headache Vascular disorder Cough, sore throat Pulmonary infiltrates Nausea/ Vomiting Constipation, anorexia, diarrhoea, muscositis
Glavobol Žilna bolezen Kašelj, vneto grlo Pljučni infiltrati Slabost/ bruhanje Zaprtje, anoreksija, diareja, vnetje sluznice
Hepatobiliary disorders Skin and subcutaneous tissue disorders
Bolezni jeter, žolčnika in žolčevodov
Very common Common Very rare
Zelo pogosti
Elevated GGT Alopecia, skin rash Sweet's syndrome, cutaneous vasculitis
Zvišanje gama glutamil transferaze (GGT)
Very common Very rare
Pogosti Zelo redki
Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Alopecija, izpuščaj na koži Sweetov sindrom, kožni vaskulitis
Renal and urinary disorders General disorders and administration site conditions
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Very rare Common Uncommon Very rare
Zelo pogosti Zelo redki
Urinary abnormalities Fatigue, generalised weakness Unspecified pain Allergic reaction
Bolezni sečil Splošne težave in spremembe na mestu aplikacije
11
Nepravilnosti sečil Utrujenost, splošna oslabelost Nespecifična bolečina Alergijska reakcija
Leukocytosis (WBC > 50 x 109/ l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim and leukapheresis was observed in 35% of donors.
Levkocitozo (število belih krvničk > 50 x 109/ l) so opazili pri 41% darovalcev, prehodno trombocitopenijo (število trombocitov < 100 x 109/ l) pa pri 35% darovalcev po odmerjanju filgrastima in po levkaferezi.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs (see section 4.4).
Pri zdravih darovalcih in bolnikih, ki so prejemali faktor, ki spodbuja rast granulocitnih kolonij, so poročali o pogostih, a v splošnem asimptomatskih primerih splenomegalije, zelo redko pa o primerih rupture vranice (glejte poglavje 4. 4).
System organ class Blood and lymphatic system disorders Metabolism and nutrition disorders
Bolezni krvi in limfatičnega sistema Presnovne in prehranske motnje
Frequency Very common Uncommon Common Uncommon
Zelo pogosti Občasni Pogosti Občasni
Undesirable effect Leukocytosis, thrombocytopenia Spleen disorder Elevated alkaline phosphatase, elevated LDH SGOT increased, hyperuricaemia
Levkocitoza, trombocitopenija Obolenje vranice Zvišanje alkalne fosfataze in LDH Zvišana SGOT, hiperurikemija
Nervous system disorders Musculoskeletal and connective tissue disorders
Bolezni živčevja Bolezni mišično- skeletnega sistema in vezivnega tkiva
Very common Very common Uncommon
Zelo pogosti Zelo pogosti Občasni
Headache Musculoskeletal pain Rheumatoid arthritis exacerbation
Glavobol Mišičnoskeletna bolečina Poslabšanje revmatoidnega artritisa
Severe allergic reaction
Resne alergijske reakcije
12 In SCN patients
Bolniki s hudo kronično nevtropenijo
Other undesirable effects seen include splenic enlargement, which may be progressive in a minority of cases and thrombocytopenia.
12 Med drugimi neželenimi učinki so opazili povečanje vranice, ki je v manjšem številu primerov lahko progresivno, ter trombocitopenijo.
There have been very few instances of proteinuria/ haematuria.
Primeri proteinurije/ hematurije so zelo redki.
System organ class Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema
Frequency Very common Common Uncommon
Zelo pogosti Pogosti Občasni
Undesirable effect Anaemia, splenomegaly Thrombocytopenia Spleen disorder
Anemija, splenomegalija Trombocitopenija Obolenje vranice
Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Znižanje glukoze, zvišanje alkalne fosfataze in LDH, hiperurikemija
Nervous system disorders Respiratory, thoracic and mediastinal disorders
Bolezni živčevja Bolezni dihal, prsnega koša in mediastinalnega prostora
Common Very common
Pogosti Zelo pogosti
Headache Epistaxis
Glavobol Epistaksa
Gastrointestinal disorders Hepatobiliary disorders Skin and subcutaneous tissue disorders
Bolezni prebavil Bolezni jeter, žolčnika in žolčevodov
Common Common Common
Diareja Hepatomegalija
Diarrhoea Hepatomegaly Alopecia, cutaneous vasculitis, injection site pain, rash
Alopecija, kožni vaskulitis, bolečina na mestu vboda, izpuščaj
Musculoskeletal and connective tissue disorders Renal and urinary disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Bolezni sečil
Musculoskeletal pain Osteoporosis Haematuria, proteinuria
Mišičnoskeletna bolečina Osteoporoza Hematurija, proteinurija
As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear.
Ker je zvečanje vranice pri bolnikih, okuženih s HIV, pogosto in ker je v različni meri prisotno pri večini bolnikov z AIDS- em, povezava s filgrastimom ni jasna.
System organ class
Neželeni učinek Organski sistem
Spleen disorder
Obolenje vranice
Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
13 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.
Colony stimulating factors, ATC code:
Farmakoterapevtska skupina: faktorji, ki spodbujajo rast kolonij, oznaka ATC:
Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Faktor, ki spodbuja rast granulocitnih kolonij pri človeku (G- CSF), je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
Biograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Zdravilo Biograstim, ki vsebuje rekombinantni človeški G- CSF (filgrastim) v 24- ih urah povzroči izrazito zvišanje števila nevtrofilcev v periferni krvi, medtem ko je zvišanje monocitov manjše.
These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of or in addition to bone marrow transplantation.
Te avtologne matične celice iz periferne krvi se lahko zbere in infundira po visoko- odmerni citotoksični kemoterapiji, bodisi namesto ali kot dodatek k presaditvi kostnega mozga.
Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of 4 x 106 CD34+ cells/ kg recipient body weight in the majority of the donors after two leukaphereses.
Pred alogensko presaditvijo matičnih celic iz periferne krvi uporaba filgrastima za zbiranje matičnih celic pri običajnih darovalcih omogoča, da se zbere 4 x 106 CD34+ celic/ kg telesne teže prejemnika pri večini darovalcev, ki so bili deležni dveh levkaferez.
Normal donors are given a dose of a 10 μ g/ kg/ day, administered subcutaneously for 4 to 5 consecutive days.
Običajni darovalci prejmejo odmerek 10 μg/ kg/ dan, ki se jim odmerja po subkutani poti 4 ali 5 dni zapored.
Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
Uporaba filgrastima pri bolnikih, otrocih in odraslih s hudo kongenitalno/ ciklično/ idiopatično nevtropenijo povzroči trajno zvišanje absolutnega števila nevtrofilcev v periferni krvi ter s tem zmanjšuje okužbe in z njimi povezane zaplete.
14 Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive medicinal product.
Uporaba filgrastima pri bolnikih z okužbo HIV pomaga ohranjati število nevtrofilcev ter tako omogoča predvideno odmerjanje antivirusnih in/ ali drugih mielosupresivnih zdravil.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Tako kot pri drugih hematopoetičnih rastnih faktorjih so tudi pri G- CSF pokazali, da in vitro spodbuja človeške endotelijske celice.
The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
14 Učinkovitost in varnost Biograstima sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne- Hodkinovim limfomom.
The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/ min/ kg.
Razpolovni eliminacijski čas odstranjevanja filgrastima iz telesa znaša približno 3, 5 ur; očistek znaša približno 0, 6 ml/ min/ kg.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 to 16 hours.
Po subkutanem aplikaciji priporočenih odmerkov je bila koncentracija seruma naslednjih 8 do 16 ur višja od 10 ng/ ml.
The volume of distribution in blood is approximately 150 ml/ kg.
Volumen porazdelitve v krvi znaša približno 150 ml/ kg.
Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 Water for injections
Ocetna kislina, koncentrirana; ledocet Natrijev hidroksid Sorbitol (E420) Polisorbat 80 Voda za injekcije
15 Biograstim should not be diluted with sodium chloride solution.
Zdravila Biograstim ne smemo mešati z raztopino natrijevega klorida.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6. 6.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
Če ni razredčeno v skladu z navodili v poglavju 6. 6, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Po redčenju: razredčena raztopina za infundiranje ostane kemično in fizikalno stabilna še 24 ur pri temperaturi od 2°C do 8 °C.
For storage conditions of the diluted medicinal product, see section 6.3.
Pogoji hranjenja razredčenih zdravil so opisani v poglavju 6. 3.
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 infusion.
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 injiciranje ali infundiranje.
If required, Biograstim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Če je potrebno, lahko zdravilo Biograstim razredčite v glukozi 50 mg/ ml (5%) raztopini za infundiranje.
Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time.
(2 μg).
For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μ g) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ ml.
(15 μg) na ml, morate končni koncentraciji 2 mg/ ml dodati še raztopino humanega albumina (» human serum albumin « - HSA).
In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μ g) should be given with 0.2 ml of 200 mg/ ml (20%) human albumin solution added.
(300 μg) dodati 0, 2 ml 20% raztopine humanega albumina.
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Biograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Če je razredčeno v glukozi 50 mg/ ml (5%) raztopini za infundiranje, je zdravilo Biograstim kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Ker obstaja tveganje mikrobne kontaminacije so z zdravilom ratiofrastim napolnjene brizge namenjene izključno enkratni uporabi.
16 Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
Če je zdravilo Biograstim pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin Germany info@ct-arzneimittel. de
16 CT Arzneimittel GmbH Lengeder Straße 42a D- 13407 Berlin Nemčija info@ ct- arzneimittel. de
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRVE PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobni podatki o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Biograstim 48 MIU/ 0.8 ml solution for injection or infusion
Biograstim 48 000 k. i. e. / 0, 8 ml raztopina za injiciranje ali infundiranje
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 ml solution for injection or infusion.
(480 µg) filgrastima v 0, 8 ml raztopine za injiciranje ali infundiranje.
18 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
18 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.
1 or
Za infundiranje je potrebno filgrastim razredčiti v 20 ml glukoze 50 mg/ ml (5%) raztopini za infundiranje (postopek redčenja je 19 opisan v poglavju 6. 6).
19 2 leukaphereses on days 5 and 6 are often sufficient.
Časovna razporeditev levkaferez: običajno zadostujeta 1 do 2 levkafrezi 5. in 6. dan.
20 > 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.
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.
21 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.
21 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.
22 population.
22 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.
Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
23 Levkafereze ne smemo izvajati pri darovalcih, ki prejemajo zdravila proti strjevanju krvi ali imajo motnje hemostaze.
23 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.
24 radiographically, occurred early during filgrastim therapy and tended to plateau.
Povečanje, zmerjeno z radiografijo, se je pojavilo v zgodnji fazi zdravljenja s filgrastimom, nato pa se je umirilo.
Biograstim contains sorbitol.
25 Zdravilo Biograstim vsebuje sorbitol.
25 Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Možnih interakcij z drugimi hemotopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso posebej raziskali.
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.
26 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.
26 Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Reverzibilno, od odmerka odvisno blago do zmerno zvišanje laktatne dehidrogenaze (LDH), alkalne fosfataze, sečne kisline in gama- glutamiltransferaze (GGT) se je pojavilo pri 50%, 35%, 25% in 10% bolnikov, ki so prejemali filgrastim v priporočenem odmerku.
27
Nepravilnosti sečil Utrujenost, splošna oslabelost Nespecifična bolečina Alergijska reakcija
28 In SCN patients
Bolniki s hudo kronično nevtropenijo