qanastek/EMEA-V3 huggingface dataset:
For further instructions on dilution with glucose 50 mg/ ml (5%) solution prior to infusion see section 6.6.
Għal struzzjonijiet addizzjonali dwar id- dilwizzjoni b’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose qabel l- infużjoni, ara sezzjoni 6. 6.
Mobilisation of PBPC Subcutaneous injection.
Mobilizzazzjoni tal- PBPC Injezzjoni taħt il- ġilda.
For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation the recommended dose of filgrastim may also be administered as a 24 hour subcutaneous continuous infusion.
Għall- mobilizzazzjoni tal- PBPC f’ pazjenti li jkunu qed jirċievu terapija majelosoppressiva jew majeloablattiva segwita minn trapjant ta ’ PBPC awtologi, id- doża rakkomandata ta ’ filgrastim tista ’ tingħata wkoll bħala infużjoni kontinwa taħt il- ġilda fuq perjodu ta ’ 24 siegħa.
For infusions filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution.
Għall- infużjoniet, filgrastim għandu jiġi dilwit f’ 20 ml ta ’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose.
SCN/ HIV infection Subcutaneous injection.
Infezzjoni b’ SCN/ HIV Injezzjoni taħt il- ġilda.
Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established posology regimens (see below).
Filgrastim m’ għandux jintuża biex iżid id- doża tal- kimoterapija ċitotossika lilhemm minn korsijiet ta ’ pożoloġija stabbiliti (ara hawn taħt).
5 Filgrastim should not be administered to patients with severe congenital neutropenia (Kostmann's syndrome) with abnormal cytogenetics (see below).
5 Filgrastim m’ għandux jingħata lil pazjenti b’ newtropenja severa konġenitali (is- sindrome ta ’ Kostmann) b’ ċitoġeniċi anormali (ara hawn taħt).
Malignant cell growth Since investigations showed that G-CSF can promote growth of myeloid cells in vitro the following warnings should be considered.
Tkabbir malinn taċ- ċelluli Minħabba li l- investigazzjonijiet urew li G- CSF jista ’ jippromwovi t- tkabbir ta ’ ċelluli majelojde in vitro, it- twissijiet li ġejjin għandhom jiġu kkunsidrati.
The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Is- sigurtà u l- effikaċja tal- għoti ta ’ filgrastim f’ pazjenti bis- sindrome majelodisplastiku, jew b’ lewkemija majeloġena kronika, ma kinux stabbiliti.
Therefore filgrastim is not indicated for use in these conditions.
Għalhekk filgrastim mhuwiex indikat għall- użu f’ dawn il- kundizzjonijiet.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Għandha tingħata attenzjoni partikulari biex wieħed jiddistingwi d- dijanjosi tat- trasformazzjoni tal- blasts ta ’ lewkimja majelojde kronika minn lewkimja majelojde akuta.
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Minħabba d- dejta limitata dwar is- sigurtà u l- effikaċja f’ pazjenti b’ AML sekondarja, filgrastim għandu jingħata bl- attenzjoni.
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.
Is- sigurtà u l- effikaċja tal- għoti ta ’ filgrastim f’ pazjenti AML de novo li kellhom < 55 sena b’ ċitoġeniċi tajbin [t( 8; 21), t( 15; 17), u inv( 16)] ma kinux stabbiliti.
Leucocytosis 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 MU/ kg/ day (3 μ g/ kg/ day).
Lewkoċitosi Għadd taċ- ċelluli tad- demm bojod ta ’ 100 x 109/ l jew iżjed kien osservat f’ inqas minn 5% tal- pazjenti li kienu qed jirċievu filgrastim f’ dożi ta ’ iktar minn 0. 3 MU/ kg/ kuljum (3 μg/ kg/ kuljum).
No undesirable effects directly attributable to this degree of leucocytosis have been reported.
L- ebda effetti mhux mixtieqa attribwibbli direttament għal dan il- grad ta ’ lewkoċitosi ma kienu rrappurtati.
However, in view of the potential risks associated with severe leucocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Madankollu, minħabba r- riskji potenzjali assoċjati ma ’ lewkoċitosi severa, għadd taċ- ċelluli tad- demm bojod għandu jitwettaq f’ intervalli regolari matul it- terapija b’ filgrastim.
If leukocyte counts exceed 50 x 109/ l after the expected nadir, filgrastim should be discontinued immediately.
Jekk l- għadd tal- lewkoċiti jaqbeż 50 x 109/ l wara l- għadd minimu mistenni, filgrastim għandu jitwaqqaf immedjatament.
However, during the period of administration of filgrastim for PBPC mobilisation, it should be discontinued or its dose should be reduced if the leukocyte counts rise to > 70 x 109/ l.
Madankollu, matul il- perjodu tal- għoti ta ’ filgrastim għal mobilizzazzjoni tal- PBPC, dan għandu jitwaqqaf jew id- doża tiegħu għandha titnaqqas jekk l- għadd tal- lewkoċiti jitla ’ għal > 70 x 109/ l.
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).
Riskji assoċjati ma ’ żieda fid- dożi tal- kimoterapija Għandha tintuża attenzjoni speċjali meta wieħed jikkura pazjenti b’ doża għolja ta ’ kimoterapija minħabba li ma ntweriex riżultat imtejjeb tat- tumur, u dożi intensifikati ta ’ mediċini kimoterapewtiċi jistgħu jwasslu għal żieda fit- tossiċitajiet li jinkludu effetti kardijaċi, pulmonari, newroloġiċi, u dermatoloġiċi (jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott tal- mediċini tal - kimoterapija speċifika li tintuża).
Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Il- kura b’ filgrastim waħdu ma tipprekludix it- tromboċitopenja u l- anemija minħabba kimoterapija majelosoppressiva.
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.
Minħabba l- potenzjal li tirċievi dożi ogħla ta ’ kimoterapija (eż. dożi sħaħ fuq l - iskeda preskritta) il- pazjent jista ’ jkun f’ riskju ikbar ta ’ tromboċitopenja u anemija.
Regular monitoring of platelet count and haematocrit is recommended.
Monitoraġġ regolari tal- għadd tal- plejtlits u tal- ematokrit hu rakkomandat.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Għandha tingħata attenzjoni speċjali meta tagħti mediċini kimoterapewtiċi waħidhom jew flimkien, li hu magħruf li jikkawżaw tromboċitopenja severa.
The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Intwera li l- użu tal- PBPCs immobilizzati b’ filgrastim inaqqas il- profondità u t- tul ta ’ tromboċitopenja wara kimoterapija majelosoppressiva jew majeloablattiva.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Prekawzjonijiet speċjali oħrajn L- effetti ta ’ filgrastim f’ pazjenti bi proġenituri majelojdi mnaqqsa b’ mod sostanzjali ma kinux studjati.
Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Filgrastim jaġixxi primarjament fuq prekursuri newtrofili biex jeżerċita l- effett tiegħu biex iżid l - għadd tan- newtrofili.
Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Għalhekk, f’ pazjenti bi prekursuri mnaqqsa, ir- rispons tan- newtrofili jista ’ jitnaqqas (bħal dawk ikkurati b’ radjuterapija jew kimoterapija estensivi, jew dawk b’ infiltrazzjoni tal - mudullun mit- tumur).
There have been reports of Graft versus Host Disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
Kien hemm rapporti ta ’ Graft versus Host Disease (GvHD) u fatalitajiet f’ pazjenti li kienu qed jirċievu G- CSF wara trapjant alloġeneiku tal- mudullun (ara sezzjoni 5. 1).
6 Mobilisation of PBPC
6 Mobilizzazzjoni tal- PBPC
Prior exposure to cytotoxic agents Patients who have undergone very extensive prior myelosuppressive therapy, followed by administration of filgrastim for mobilisation of PBPCs, may not show sufficient mobilisation of these blood cells to achieve the recommended minimum yield (≥ 2.0 x 106 CD34+ cells/ kg) or acceleration of platelet recovery to the same degree.
Espożizzjoni fil- passat għal mediċini ċitotossiċi Pazjenti li kellhom terapija majelosoppressiva estensiva ħafna fil- passat, segwita mill- għoti ta ’ filgrastim għall- mobilizzazzjoni tal- PBPCs, jistgħu ma jurux mobilizzazzjoni suffiċjenti ta ’ dawn iċ - ċelluli tad- demm biex jiksbu l- ammont minimu rakkomandat (≥ 2. 0 x 106 CD34+ ċelluli/ kg) jew l - aċċelerazzjoni tal- irkuprar tal- plejtlits għall- istess grad.
Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Xi mediċini ċitotossiċi juru tossiċitajiet partikulari għal pool ta ’ proġenituri ematopojetiċi u jistgħu jaffettwaw b’ mod avvers il- mobilizzazzjoni tal- proġenituri.
Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
Mediċini bħal melphalan, carmustine (BCNU) u carboplatin, meta jingħataw fuq perjodi twal ta ’ żmien qabel ma wieħed jipprova l - mobilizzazzjoni tal- proġenituri, jistgħu jnaqqsu l- ammont tal- proġenituri.
However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Madankollu, intwera li l - għoti ta ’ melphalan, carboplatin jew BCNU flimkien ma ’ filgrastim kien effettiv għall- mobilizzazzjoni tal- proġenituri.
When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Meta trapjant tal- PBPC ikun ippjanat, hu rakkomandat li tippjana l- proċedura tal - mobilizzazzjoni taċ- ċelluli staminali kmieni fil- kors tal- kura tal- pazjent.
Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Attenzjoni partikulari għandha tingħata lin- numru ta ’ proġenituri immobilizzati f’ dawn il- pazjenti qabel l- għoti ta ’ doża għolja ta ’ kimoterapija.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Jekk l- ammonti prodotti jkunu inadegwati, kif imkejla mill- kriterji t’ hawn fuq, forom alternattivi ta ’ kura li ma jeħtiġux sapport tal- proġenituri, għandhom jiġu kkunsidrati.
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.
Evalwazzjoni tal- ammonti prodotti ta ’ ċelluli proġenituri Fl- evalwazzjoni tan- numru ta ’ ċelluli proġenituri miġbura f’ pazjenti kkurati b’ filgrastim, għandha tingħata attenzjoni partikulari għall- metodu ta ’ kwantifikazzjoni.
The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Ir- riżultati tal- analiżi tal- fluss ċitometriku tan- numri taċ- ċelluli CD34+ tvarja skont il- metodoloġija preċiża li tintuża u għalhekk, rakkomandazzjonijiet dwar numri bbażati fuq studji f’ laboratorji oħrajn jeħtieġ li jkunu interpretati bl - attenzjoni.
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.
Analiżi statistika tar- relazzjoni bejn in- numru ta ’ ċelluli CD34+ li jkunu infużi mill- ġdid u r- rata ta ’ irkuprar tal- plejtlits wara kimoterapija b’ doża għolja tindika relazzjoni kumplessa iżda kontinwa.
The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/ kg is based on published experience resulting in adequate haematologic reconstitution.
Ir - rakkomandazzjoni ta ’ ammont prodott minimu ta ’ ≥ 2. 0 x 106 CD34+ ċelluli/ kg hu bbażat fuq esperjenza ppubblikata li tirriżulta f’ rikostituzzjoni ematoloġika adegwata.
Yields in excess of this minimum yield appear to correlate with more rapid recovery, those below with slower recovery.
L- ammonti prodotti iżjed minn dan l- ammont minimu jidhru li jikkorrelaw ma ’ irkuprar iktar mgħaġġel, dawk inqas ma ’ irkuprar iktar bil- mod.
Normal donors prior to allogeneic PBPC transplantation Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Donaturi normali qabel trapjant alloġeneiku tal- PBPC Il- mobilizzazzjoni tal- PBPC ma tipprovdix benefiċċju kliniku dirett lil donaturi normali u għandha tiġi kkunsidrata biss għall- iskop ta ’ trapjant ta ’ ċelluli staminali alloġeneiċi.
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.
Il- mobilizzazzjoni tal- PBPC għandha tiġi kkunsidrata biss f’ donaturi li jissodisfaw il- kriterji tal - eliġibilità normali kliniċi u tal- laboratorju għal donazzjoni ta ’ ċelluli staminali, b’ attenzjoni speċjali għall- valuri ematoloġiċi u mard infettiv.
The safety and efficacy of filgrastim have not been assessed in normal donors< 16 years or > 60 years.
Is- sigurtà u l- effikaċja ta ’ filgrastim ma kinux evalwati f’ donaturi normali ta ’ < 16- il sena jew ta ’ > 60 sena.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Tromboċitopenja temporanja (plejtlits < 100 x 109/ l) wara l- għoti ta ’ filgrastim u lewkaferesi kienet osservata f’ 35% tal- pazjenti studjati.
Among these, two cases of platelets < 50 x 109/ l were reported and attributed to the leukapheresis procedure.
Fost dawn, żewġ każijiet b’ għadd tal- plejtlits ta ’ < 50 x 109/ l kienu rrappurtati u attribwiti għall- proċedura tal- lewkaferesi.
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.
Jekk iktar minn lewkaferesi waħda tkun meħtieġa, għandha tingħata attenzjoni partikulari għal donaturi b’ għadd tal- plejtlits ta ’ < 100 x 109/ l qabel il- lewkaferesi; b’ mod ġenerali l- aferesi m’ għandhiex titwettaq jekk l- għadd tal- plejtlits ikun ta ’ < 75 x 109/ l.
Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Il- lewkaferesi m’ għandhiex titwettaq f’ donaturi li jkunu antikoagulati jew li jkollhom difetti magħrufa fl- emostasi.
Filgrastim administration should be discontinued or its posology should be reduced if the leukocyte counts rise to > 70 x 109/ l.
L- għoti ta ’ filgrastim għandu jitwaqqaf jew il- pożoloġija tiegħu titnaqqas jekk l- għadd tal- lewkoċiti jiżdied għal > 70 x 109/ l.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Donaturi li jirċievu G- CSFs għal mobilizzazzjoni tal- PBPC għandhom jiġu mmonitorjati sakemm l - indiċi ematoloġiċi jerġgħu lura għan- normal.
Long-term safety follow-up of donors is ongoing.
Il- follow- up tas- sigurtà fit- tul tad- donaturi għadha 7 għaddejja.
Nevertheless, a risk of promotion of a
F’ perjodu ta ’ 4 snin, ma kien hemm l- ebda rapporti ta ’ ematopoiesi anormali f’ donaturi normali.
7 malignant myeloid clone can not be excluded.
Madankollu, ma jistax jiġi eskluż riskju ta ’ promozzjoni ta ’ klonu majelojde malinn.
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors to ensure monitoring of long-term safety.
Hu rakkomandat li ċ- ċentru tal- aferesi jwettaq rekord sistematiku u tracking tad- donaturi ta ’ ċelluli staminali biex jiżgura l- monitoraġġ tas- sigurtà fuq tul ta ’ żmien.
Transient cytogenic modifications have been observed in normal donors following G-CSF use.
Tibdil ċitoġeniku temporanju kien osservat f’ donaturi normali wara l- użu ta ’ G- CSF.
The significance of these changes in terms of the development of haematological malignancy is unknown.
Is- sinifikat ta ’ dan it- tibdil f’ termini tal- iżvilupp ta ’ malinn ematoloġiku mhuwiex magħruf.
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.
Każijiet komuni iżda ġeneralment asintomatiċi ta ’ splenomegalija u każijiet rari ħafna ta ’ ftuq tal- milsa kienu rrappurtati f’ donaturi b’ saħħithom u fil- pazjenti wara l- għoti ta ’ G- CSFs.
Some cases of splenic rupture were fatal.
Xi każijiet ta ’ ftuq tal- milsa kienu fatali.
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Għalhekk, id- daqs tal- milsa għandu jiġi mmonitorjat bl- attenzjoni (eż. eżami kliniku, ultrasound).
A diagnosis of splenic rupture should be considered in donors and/ or patients reporting left upper abdominal pain or shoulder tip pain.
Għandha tiġi kkunsidrata dijanjosi ta ’ ftuq tal- milsa f’ donaturi u/ jew pazjenti li jirrappurtaw uġigħ addominali fin- naħa tax- xellug ta ’ fuq jew uġigħ fit- tarf ta’ l- ispallejn.
In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience.
F’ donaturi normali, avvenimenti avversi pulmonari (emoptisi, emorraġija pulmonari, infiltrati pulmonari, qtugħ ta ’ nifs u nuqqas ta ’ ossiġnu) kienu rrappurtati b’ mod rari ħafna wara li prodott beda jinbiegħ.
In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with filgrastim should be considered and appropriate medical care given.
F’ każ ta ’ avvenimenti avversi pulmonari ssuspettati jew ikkonfermati, it- twaqqif tal- kura b’ filgrastim għandu jiġi kkunsidrat u għandha tingħata kura medika adattata.
Recipients of allogeneic PBPCs mobilised with filgrastim 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 bone marrow transplantation.
Reċipjenti tal- PBPCs alloġeneiċi mobilizzati b’ filgrastim Id- dejta kurrenti tindika li interazzjonijiet immunoloġiċi bejn trapjant alloġeneiku tal- PBPC u r - reċipjent jistgħu jiġu assoċjati ma ’ riskju miżjud ta ’ GvHD akut u kroniku meta mqabbel ma ’ trapjant tal- mudullun.
Blood cell counts Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Għadd taċ- ċelluli tad- demm L- għadd tal- plejtlits għandu jkun immonitorjat mill- qrib, speċjalment matul l- ewwel ftit ġimgħat tat - terapija b’ filgrastim.
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.
Għandha tingħata konsiderazzjoni għal waqfien intermittenti jew it- tnaqqis tad - doża ta ’ filgrastim f’ pazjenti li jiżviluppaw tromboċitopenja, i. e. għadd tal- plejtlits li jkun b’ mod konsistenti ta ’ < 100, 000/ mm3.
Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Tibdil ieħor fiċ- ċelluli tad- demm jseħħ, li jinkludi anemija u żidiet temporanji fil- proġenituri majelojde, li jeħtieġu monitoraġġ mill- qrib tal- għadd taċ- ċelluli.
Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia, and myeloid leukaemia.
It- trasformazzjoni għal- lewkimja jew għas- sindrome majelodisplastiku Attenzjoni specjali trid tingħata fid- dijanjosi ta ’ SCNs biex tiddistingwihom minn disturbi ematopojetiċi oħrajn bħal anemija aplastika, majelodisplasija, u lewkimja majelojde.
Complete blood cell counts with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
L- għadd sħiħ taċ - ċelluli tad- demm bl- għadd differenzjali u tal- plejtlits, u evalwazzjoni tal- morfoloġija tal- mudullun u l - karjotip għandhom jitwettqu qabel il- kura.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical study patients with SCN treated with filgrastim.
Kien hemm frekwenza baxxa (ta ’ madwar 3%) ta ’ sindromi majelodisplastiċi (MDS) jew lewkimja f’ pazjenti b’ SCN li fuqhom saru l- istudji kliniċi, ikkurati b’ filgrastim.
This observation has only been made in patients with congenital neutropenia.
Din l- osservazzjoni saret biss f’ pazjenti b’ newtropenja konġenitali.
MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
MDS u lewkimji huma kumplikazzjonijiet naturali tal- marda u għandhom relazzjoni inċerta mat- terapija b’ filgrastim.
A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline were subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Sotto- sett ta ’ madwar 12% tal- pazjenti li kellhom evalwazzjonijiet ċitoġeniċi normali fil- linja bażi, sussegwentement instab li kellhom anormalitajiet, li kienu jinkludu monosomija 7, meta saret ir- ripetizzjoni tal- evalwazzjoni ta ’ rutina.
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 occurs.
Jekk pazjenti b’ SCN jiżviluppaw ċitoġeniċi anormali, ir- riskji u l- benefiċċji li tkompli bit- terapija ta ’ filgrastim għandhom jintiżnu bl- attenzjoni; Filgrastim għandu jitwaqqaf jekk l- MDS jew il- lewkimja jseħħu.
It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Bħalissa mhuwiex ċar jekk il- kura fit- tul ta ’ pazjenti b’ SCN ser tippredisponi l- pazjenti għal anormalitajiet ċitoġeniċi, MDS jew trasformazzjoni lewkemika.
It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Hu rakkomandat li jsiru eżamijiet morfoloġiċi u ċitoġeniċi tal- mudullun fil- pazjenti f’ intervalli regolari (madwar kull 12- il xahar).
Other special precautions Causes of transient neutropenia, such as viral infections should be excluded.
Prekawzjonijiet speċjali oħrajn Il- kawżi ta ’ newtropenja temporanja, bħal infezzjonijiet virali, għandhom jiġu esklużi.
Splenic enlargement is a direct effect of treatment with filgrastim.
It- tkabbir tal- milsa hu effett dirett tal- kura b’ filgrastim.
31% of patients in studies were documented as having palpable splenomegaly.
31% tal- pazjenti fl- istudji kienu dokumentati bħala li kellhom splenomegalija li tista ’ tinħass b’ eżami bl- idejn.
Increases in volume, measured radiographically, occurred early during Filgrastim therapy and tended to plateau.
Kien
Dose reductions were noted to slow or stop the progression of splenic enlargement, and in 3% of patients a splenectomy was required.
8 osservat li tnaqqis fid- doża jnaqqas jew iwaqqaf il- progressjoni ta ’ tkabbir tal- milsa, u fi 3% tal - pazjenti, splenektomija kienet meħtieġa.
Spleen size should be evaluated regularly.
Id- daqs tal- milsa għandu jkun evalwat regolarment.
Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Eżami taż- żaqq bl- idejn (palpation) għandu jkun suffiċjenti biex jiġu osservati żidiet anormali fil- volum tal - milsa.
8 Haematuria/ proteinuria occurred in a small number of patients.
Ematurja/ proteinuria seħħet f’ numru żgħir ta ’ pazjenti.
Regular urine analyses should be performed to monitor this event.
Analiżi regolari tal- awrina għandhom jitwettqu biex isir monitoraġġ ta ’ dan l- avveniment.
The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Is- sigurtà u l- effikaċja fit- trabi tat- twelid u f’ pazjenti b’ newtropenja awtoimmuni ma kinux stabbiliti.
Blood cell counts ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Għadd taċ- ċelluli tad- demm L- ANC għandu jkun immonitorjat mill- qrib, speċjalment matul l- ewwel ftit ġimgħat tat- terapija b’ filgrastim.
Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Xi pazjenti jistgħu jirrispondu malajr ħafna u b’ żieda konsiderevoli fl- għadd tan - newtrofili, għad- doża tal- bidu ta ’ filgrastim.
It is recommended that the ANC is measured daily for the first 2 - 3 days of filgrastim administration.
Hu rakkomandat li l- ANC jitkejjel kuljum għall- ewwel 2 - 3 t’ ijiem tal- għoti ta ’ filgrastim.
Thereafter, it is recommended that the ANC is measured at least twice per week for the first 2 weeks and subsequently once per week or once every other week during maintenance therapy.
Wara dak il- perjodu, hu rakkomandat li l- ANC jitkejjel mill- inqas darbtejn kull ġimgħa għall- ewwel ġimagħejn u sussegwentement darba f’ ġimgħa jew darba kull ħmistax matul it- terapija ta ’ manutenzjoni.
During intermittent dosing with 30 MU/ day (300 μ g/ day) of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Matul id- dożaġġ intermittenti bi 30 MU/ kuljum (300 μg/ kuljum) ta ’ filgrastim, jista ’ jkun hemm fluttwazzjonijiet kbar fl- ANC tal - pazjent mal- medda taż- żmien.
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 scheduled dosing with filgrastim.
Sabiex tiddetermina l- iktar punt baxx tal- ANC ta ’ pazjent, hu rakkomandat li jittieħdu kampjuni tad- demm biex jitkejjel l- ANC immedjatament qabel kwalunkwe dożaġġ skedat b’ filgrastim.
Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive treatments.
Riskju assoċjat ma ’ żieda fid- dożi ta ’ prodotti mediċinali majelsoppressivi Il- kura b’ filgrastim waħdu ma tipprekludix it- tromboċitopenja u l- anemija minħabba kuri majelsoppressivi.
As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Bħala riżultat tal- potenzjal li jirċievi dożi ogħla jew numru ikbar ta ’ dawn il- prodotti mediċinali bit- terapija b’ filgrastim, il- pazjent jista ’ jkun f’ riskju ogħla li jiżviluppa t- tromboċitopenja u l- anemija.
Regular monitoring of blood counts is recommended (see above).
Monitoraġġ regolari tal- għadd tad- demm hu rakkomandat (ara hawn fuq).
Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow-infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Infezzjonijiet u malinni li jikkawżaw majelosoppressjoni In- newtropenja tista ’ tkun minħabba infezzjonijiet opportunistiċi li jinfiltraw il- mudullun bħall - kumpless Mycobacterium avium jew malinni bħal limfoma.
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.
F’ pazjenti b’ infezzjonijiet magħrufa opportunistiċi li jinfiltraw il- mudullun jew malinn, ikkunsidra terapija adattata għall- kura tal - kundizzjoni diġà eżistenti flimkien mal- għoti ta ’ filgrastim għal kura ta ’ newtropenja.
The effects of filgrastim on neutropenia due to bone marrow-infiltrating infection or malignancy have not been well established.
L- effetti ta ’ filgrastim fuq in- newtropenja minħabba infezzjoni li tinfiltra l- mudullun jew malinn, ma kinux stabbiliti tajjeb.
Other special precautions
Prekawzjonijiet speċjali oħrajn
Rare pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration (see section 4.8).
Reazzjonijiet avversi pulmonari rari, b’ mod partikulari pnewmonja interstizjali, kienu rrappurtati wara l- għoti ta ’ G- CSF (ara sezzjoni 4. 8).
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Pazjenti bi storja medika riċenti ta ’ infiltrati pulmonari jew pnewmonja jistgħu jkunu f’ riskju ogħla.
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).
Il- bidu ta ’ sinjali pulmonari, bħal sogħla, deni u qtugħ ta ’ nifs b’ rabta ma ’ sinjali radjoloġiċi ta ’ infiltrati pulmonari u deterjorament fil- funzjoni pulmonari, jistgħu jkunu sinjali preliminari tas- Sindrome ta ’ Problemi Respiratorji fl- Adulti (ARDS).
Filgrastim should be discontinued and appropriate treatment given in these cases.
Filgrastim għandu titwaqqaf u tingħata kura adattata f’ dawn il- każijiet.
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.
Il- monitoraġġ tad- densità tal- għadam jista ’ jkun indikat f’ pazjenti li jkollhom mard eżistenti osteoporotiku tal- għadam li jirċievu terapija kontinwa b’ filgrastim għal iktar minn 6 xhur.
Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell disease.
Kriżijiet taċ- ċelluli sickle, f’ xi każijiet fatali, kienu rrappurtati bl- użu ta ’ filgrastim f’ persuni li kellhom il- marda taċ- ċelluli sickle.
Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell disease, and only after careful evaluation of the potential risks and benefits.
It- tobba għandhom joqogħdu attenti meta jikkunsidraw l- użu ta ’ filgrastim f’ pazjenti bil- marda taċ- ċelluli sickle, u għandhom jagħmlu dan biss wara evalwazzjoni bir- reqqa tar - riskji u l- benefiċċji potenzjali.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Żieda fl- attività ematopojetika tal- mudullun b’ rispons għat- terapija tal- fattur tat- tkabbir, kienet assoċjata ma ’ sejbiet temporanji pożittivi tal- immaġni tal- għadam.
This should be considered when interpreting bone imaging results.
Dan għandu jiġi kkunsidrat meta wieħed jinterpreta r- riżultati tal- immaġni tal- għadam.
Excipients
9 Sustanzi mhux attivi
Filgrastim HEXAL contains sorbitol.
Filgrastim HEXAL fih sorbitol.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall - fructose, m’ għandhomx jużaw dan il- prodott mediċinali.
9 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Is- sigurtà u l- effikaċja ta ’ filgrastim mogħti fl- istess jum li tingħata l- kimoterapija ċitotossika majelosoppressiva ma kinux stabbiliti b’ mod definittiv.
In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Minħabba s- sensittività taċ- ċelluli majelojde li jinqasmu malajr għal kimoterapija ċitotossika majelosoppressiva, l- użu ta ’ filgrastim mhuwiex rakkomandat fil- perjodu minn 24 siegħa qabel sa 24 siegħa wara l- kimoterapija.
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-fluorouracil indicates that the severity of neutropenia may be exacerbated.
Evidenza preliminari minn numru żgħir ta ’ pazjenti li kienu kkurati fl- istess ħin b’ filgrastim u b’ 5- fluorouracil tindika li s - severità tan- newtropenja tista ’ tiħrax.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Interazzjonijiet possibbli ma ’ fatturi tat- tkabbir ematopojetiċi oħra u cytokines, s’ issa ma kinux investigati fi studji kliniċi.
Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of filgrastim.
Billi l- lithium jippromwovi l- ħruġ tan- newtrofili, il- lithium x’ aktarx li ser iżid l- effett ta ’ filgrastim.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Għalkemm din l- interazzjoni ma kinitx investigata formalment, m’ hemm l- ebda evidenza li interazzjoni bħal din hi ta ’ ħsara.
There are no adequate data from the use of filgrastim in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ filgrastim waqt it- tqala.
There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Hemm rapporti fil- letteratura fejn intwera l- passaġġ transplaċentali ta ’ filgrastim f’ nisa tqal.
There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
M’ hemm l- ebda evidenza minn studji fuq il - firien u l- fniek li filgrastim hu teratoġeniku.
An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
Żieda fl- inċidenza ta ’ telf tal- embriju kienet osservata fil - fniek, iżda ma kienet osservata l- ebda malformazzjoni.
In pregnancy, the possible risk of filgrastim use to the foetus must be weighed against the expected therapeutic benefit.
Fit- tqala, ir- riskju possibbli tal- użu ta ’ filgrastim għall- fetu jrid jintiżen kontra l- benefiċċju terapewtiku mistenni.
It is not known whether filgrastim is excreted in human milk, therefore it is not recommended for use in breast-feeding women.
Mhux magħruf jekk filgrastim jitneħħiex fil- ħalib tal- bniedem; għalhekk, it- treddigħ mhux rakkomandat għall- użu f’ nisa li jkunu qed ireddgħu.
Filgrastim has no influence on the ability to drive and use machines.
Filgrastim m’ għandu l- ebda effett fuq il- ħila biex issuq u biex tuża l- magni.
The most commonly reported adverse reactions to filgrastim are mild to moderate musculoskeletal pain occurring in more than 10% of patients.
L- iktar reazzjonijiet avversi għal filgrastim li kienu rrappurtati b’ mod komuni huma wġigħ muskoloskeletriku minn ħafif sa moderat li jseħħ f’ iktar minn 10% ta ’ pazjenti.
Musculoskeletal pain is usually controlled with standard analgesics.
L- uġigħ muskoloskeletriku normalment ikun ikkontrollat b’ analġesiċi standard.
Adverse reactions listed below are classified according to frequency and system organ class.
Ir- reazzjonijiet avversi elenkati hawn taħt huma kklassifikati skont il- frekwenza u l- klassi tal- organi tas- sistema.
Frequency groupings are defined according to the following convention:
Il- kategoriji ta ’ frekwenza huma definiti skont il- konvenzjoni li ġejja:
Very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari (≥ 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000, mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
10 Table 1.
10 Tabella 1.
Adverse reactions in clinical trials in cancer patients Immune system disorders
Reazzjonijiet avversi fi provi kliniċi f’ pazjenti bil- kanċer Disturbi fis- sistema immuni
Allergic-type reactions*, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension
Reazzjonijiet qishom allerġija *, li jinkludu anafilassi, raxx tal- ġilda, urtikarja, anġjoedema, qtugħ ta ’ nifs u pressjoni baxxa
Vascular disorders Uncommon:
Disturbi vaskulari Mhux komuni:
Hypotension (transient)
Pressjoni baxxa (temporanja)
Vascular disorders* including venoocclusive disease and fluid volume disturbances
Mard vaskulari * li jinkludi mard veno- okklużiv u disturbi fil- volum tal - fluwidu
Pulmonary oedema*, interstitial pneumonia*, pulmonary infiltrates*
Edema pulmonari *, pnewmonja interstizjali *, infiltrati pulmonari *
Sweet's Syndrome*, cutaneous vasculitis
Is- Sindrome ta ’ Sweet *, vaskulite tal- ġilda
Musculoskeletal, connective tissue and bone disorders Very common:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni ħafna:
Musculoskeletal pain (mild or moderate)
Uġigħ muskoloskeletriku (ħafif jew moderat)
Musculoskeletal pain (severe) Rheumatoid arthritis exacerbation
Uġigħ muskoloskeletriku (sever) Aggravament ta ’ artrite rewmatojde
Micturition disorders (predominantly dysuria)
Disturbi meta tagħmel l- awrina (fil- biċċa l- kbira tagħhom diffikultà biex tagħmel l- awrina)
Investigations Very common:
Investigazzjonijiet Komuni ħafna:
Blood alkaline phosphatase, blood lactate dehydrogenase (LDH), gamma-glutamyltransferase (GGT) and blood uric acid increased (reversible, dose-dependent, mild or moderate) * see below
Żieda fl- alkaline phosphatase fid- demm, fil- lactate dehydrogenase (LDH) fid- demm, gamma- glutamyltransferase (GGT) u żieda fil- uric acid fid- demm (riversibbli, jiddependi mid- doża, ħafif jew moderat) * ara hawn taħt
Adverse reactions in clinical trials in normal donors undergoing PBPC mobilisation Immune system disorders Uncommon:
Reazzjonijiet avversi fi provi kliniċi f’ donaturi normali li jkollhom mobilizzazzjoni tal - PBPC Disturbi fis- sistema immuni Mhux komuni:
Severe allergic reaction: anaphylaxis, angioedema, urticaria, rash Blood and the lymphatic system disorders Very common:
Reazzjoni allerġika severa: anafilassi, anġjoedema, urtikarja, raxx Disturbi tad- demm u tas- sistema limfatika Komuni ħafna:
Leucocytosis (WBC > 50 x 109/ l), thrombocytopenia (platelets < 100 x 109/ l; transient)
Lewkoċitosi (WBC > 50 x 109/ l), tromboċitopenja (plejtlits < 100 x 109/ l; temporanja)
Splenomegaly (generally asymptomatic, also in patients)
Splenomegalija (ġeneralment asintomatika, tkun osservata wkoll fil - pazjenti)
Spleen disorder
Disturb fil- milsa
Splenic rupture (also in patients)
Ftuq fil- milsa (tkun osservata wkoll fil- pazjenti)
Nervous system disorders Very common:
Disturbi fis- sistema nervuża Komuni ħafna:
Headache Respiratory, thoracic and mediastinal disorders
Uġigħ ta ’ ras Disturbi respiratorji, toraċiċi u medjastinali
Haemoptysis*, pulmonary haemorrhage*, pulmonary infiltrates*, dyspnoea*, hypoxia*
emoptisi *, emorraġija pulmonari *, infiltrati pulmonari *, qtugħ ta ’ nifs *, nuqqas ta ’ ossiġnu *
Musculoskeletal pain (mild to moderate, transient) Uncommon:
Uġigħ muskoloskeletriku (minn ħafif sa moderat, temporanju) Mhux komuni:
Rheumatoid arthritis and arthritic symptoms exacerbation Investigations
Artrite rewmatojde u aggravament tas- sintomi artritiċi Investigazzjonijiet
Blood alkaline phosphatase and LDH increased (transient, minor)
Żieda fl- alkaline phosphatase fid- demm u fl- LDH (temporanja, żgħira)
Aspartate aminotransferase (AST) and blood uric acid increased (transient, minor) * see below
Żieda fl- aspartate aminotransferase (AST) u żieda fil- uric acid fid - demm (temporanja, żgħira) * ara hawn taħt
Adverse reactions in clinical trials in SCN patients Blood and the lymphatic system disorders Very common:
Reazzjonijiet avversi fi provi kliniċi f’ pazjenti b’ SCN Disturbi tad- demm u tas- sistema limfatika Komuni ħafna:
Anaemia, splenomegaly (may be progressive in a minority of cases)
Anemija, splenomegalija (tista ’ tkun progressiva fil- minorità tal - każijiet)
Spleen disorder Nervous system disorders
Disturb fil- milsa Disturbi fis- sistema nervuża
Respiratory, thoracic and mediastinal disorders Very common:
Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
Epistaxis Gastrointestinal disorders
Tinfaraġ Disturbi gastro- intestinali
Hepatomegaly
Epatomegalija
Cutaneous vasculitis (during long term use), alopecia, rash
Vaskulite tal- ġilda (matul l- użu fit- tul), alopeċja, raxx
General musculoskeletal pain, bone pain
Uġigħ muskoloskeletriku ġenerali, uġigħ fl- għadam
Osteoporosis, arthralgia
Osteoporożi, artralġja
Renal and urinary disorders Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni:
Haematuria, proteinuria General disorders and administration site conditions
Ematurja, proteinuria Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
Injection site pain
Uġigħ tal- parti fejn tingħata l- injezzjoni
Blood alkaline phosphatase, LDH and blood uric acid increased (transient), blood glucose decreased (transient, moderate)
Żieda fl- alkaline phosphatase fid- demm, żieda f’ LDH u fil- uric acid fid - demm (temporanja), tnaqqis fil- glucose fid- demm (temporanju, moderat)
Adverse reactions in clinical trials in HIV Patients Blood and lymphatic system disorders
Reazzjonijiet avversi fi provi kliniċi f’ Pazjenti bl- HIV Disturbi tad- demm u tas- sistema limfatika
Spleen disorder, splenomegaly*
Disturbi fil- milsa, splenomegalija *
Musculoskeletal pain (mild to moderate) * see below
Uġigħ muskoloskeletriku (ħafif sa moderat) * ara hawn taħt
In randomised, placebo-controlled clinical studies, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Fi studji kliniċi, randomised, ikkonrollati bil- plaċebo, filgrastim ma żiedx l- inċidenza tal- effetti mhux mixtieqa assoċjati ma ’ kimoterapija ċitotossika.
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.
L- effetti mhux mixtieqa rrappurtati bi frekwenza ugwali f’ pazjenti kkurati b’ filgrastim/ kimoterapija u bil- plaċebo/ kimoterapija kienu jinkludu nawseja u rimettar, alopeċja, dijarea, għeja kbira, anoreksja, mukożite, uġigħ ta ’ ras, sogħla, raxx tal- ġilda, uġigħ fis- sider, dgħjufija ġeneralizzata, uġigħ fil- griżmejn, stitikezza u wġigħ mhux speċifikat.
Allergic reactions occurred on initial or subsequent treatment in patients receiving filgrastim.
Seħħew reazzjonijiet allerġiċi waqt il- kura inizjali jew sussegwenti f’ pazjenti li kienu qed jirċievu filgrastim.
Overall, reports were more common after intravenous administration.
Globalment, ir- rapporti kienu iktar komuni wara l- għoti ġol- vina.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
F’ xi każijiet, is- sintomi reġgħu seħħew b’ rechallenge, u dan jissuġġerixxi relazzjoni kawżali.
Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Filgrastim għandu jitwaqqaf permanentement f’ pazjenti li jkollhom reazzjoni allerġika serja.
Vascular disorders have been reported in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Il- mard vaskulari kien irrappurtat f’ pazjenti li kienu qed jirċievu kimoterapija b’ dożi qawwija segwita minn trapjant tal- mudullun.
The causal association with filgrastim has not been established.
L- assoċjazzjoni kawżali ma ’ filgrastim ma kinitx stabbilita.
Pulmonary adverse reactions have in some cases been reported with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS), which may be fatal.
Reazzjonijiet pulmonari avversi f’ xi każijiet kienu rrappurtati li kellhom riżultat ta ’ waqfien tan- nifs jew is- sindrome ta ’ problemi respiratorji fl- adulti (ARDS), li jistgħu jkunu fatali.
In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience (see section 4.4).
F’ donaturi normali, avvenimenti avversi pulmonari (emoptisi, emorraġija pulmonari, infiltrati pulmonari, qtugħ ta ’ nifs u nuqqas ta ’ ossiġnu) kienu rrappurtati b’ mod rari ħafna wara li prodott beda jinbiegħ (ara sezzjoni 4. 4).
The occurrence of Sweet's syndrome (acute febrile neutrophilic dermatosis) has been reported occasionally in cancer patients.
L- okkorrenza tas- sindrome ta ’ Sweet (dermatosi newtrofilika febbrili akuta) kienet irrappurtata kultant f’ pazjenti bil- kanċer.
12 suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Madankollu, billi perċentwali sinifikanti minn dawn il- pazjenti kienu jbatu mil - 12 lewkimja, kundizzjoni magħrufa li hi assoċjata mas- sindrome ta ’ Sweet, relazzjoni kawżali ma ’ filgrastim ma kinitx stabbilita.
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
F’ każijiet iżolati ta ’ kriżijiet taċ- ċelluli sickle kienu rrappurtati f’ pazjenti bil- marda taċ- ċelluli sickle (ara sezzjoni 4. 4).
The frequency is not known.
Il- frekwenza mhijiex magħrufa.
In all cases of splenic enlargement in HIV patients this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
Fil- każijiet kollha ta ’ tkabbir fil- milsa f’ pazjenti bl- HIV, dan kien ħafif jew moderata meta sar eżami fiżiku, u l- kors kliniku kien beninn; l- ebda pazjent ma kellu dijanjosi ta ’ iperspleniżmu u l- ebda pazjent ma kellu splenektomija.
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.
Billi t- tkabbir tal- milsa jinsab b’ mod komuni f’ pazjenti b’ infezzjoni bl- HIV u jinsab fi gradi differenti fil- biċċa l- kbira pazjenti bl- AIDS, ir- relazzjoni mal- kura b’ filgrastim mhijiex ċara.
In four clinical studies none of the healthy volunteers or cancer patients developed anti-rhG-CSF antibodies (neither binding nor neutralising) upon treatment with Filgrastim HEXAL.
F’ erba ’ studji kliniċi, l- ebda wieħed mill- voluntiera b’ saħħithom jew pazjenti bil- kanċer ma żviluppa antikorpi anti- rhG- CSF (la li jeħlu u lanqas li jinnewtralizzaw) meta ngħataw kura b’ Filgrastim HEXAL.
The effects of filgrastim overdose have not been established.
L- effetti ta ’ doża eċċessiva ta ’ filgrastim ma kinux stabbiliti.
Colony stimulating factors, ATC Code:
Fatturi li jistimulaw il- kolonji, Kodiċi ATC:
Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
G- CSF umana hi glikoproteina li tirregola l- produzzjoni u l- ħruġ ta ’ newtrofili funzjonali mill - mudullun.
Filgrastim HEXAL containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Filgrastim HEXAL li fih r- metHuG- CSF (filgrastim) jikkawża żidiet notevoli fl- għadd tan - newtrofili tad- demm periferali fi żmien 24 siegħa, b’ żidiet żgħar fil- monoċiti.