qanastek/EMEA-V3 huggingface dataset:
Filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Għall- infużjoni, id- doża ta ’ filgrastim trid tkun miżjuda ma ’ 20ml soluzzjoni ta ’ glucose 50 mg/ ml (5%) (ara sezzjoni 6. 6 għall- istruzzjonijiet fuq id- dilwit).
The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
L- ewwel doża ta ’ filgrastim m’ għandiex tingħata inqas minn 24 siegħa wara l- kimoterapija ċitotossika u fiż- żmien ta ’ 24 siegħa wara infużjoni tal- mudullun.
Once the neutrophil nadir has been passed the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Wara li n- nadir mistenni fil- livell ta ’ newtrofili jkun għadda, id- doża ta ’ kuljum ta ’ filgrastim trid tinħadem skond l- għadd ta ’ newtrofili kif ġej:
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
> 1. 0 x 10 / l għal 3 ijiem konsekuttivi
Filgrastim dose adjustment Reduce to 0.5 MIU (5 µg)/ kg/ day Discontinue filgrastim
Naqqas għal 0. 5 MIU (5 µg) / kg/ jum
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
Imbagħad, jekk l- ANC jibqa ’ > 1. 0 x 109/ l għal 3 - Waqqaf il- kura b ’ filgrastim ijiem konsekuttivi oħra Jekk l- ANC jonqos għal < 1. 0 x 109/ l waqt il- perijodu ta ’ kura, id- doża ta ’ filgrastim għandha terġa tittella skond ir- rakkomandazzjonijiet imsemmija hawn fuq.
For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous peripheral blood progenitor cell transplantation
Għall- mobilizzazzjoni ta ’ PBPC f’ pazjenti taħt kura majelosoppressiva jew majeloablativa segwit bit- trapjant awtolgu ta ’ ċelluli proġenitriċi tad- demm periferali
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.
Meta jintuża waħdu, id- doża rakkomandata ta ’ filgrastim għall- mobilizzazzjoni ta ’ PBPC hija 1. 0 MIU (10 μg) / kg/ jum mogħtija bħala infużjoni kontinwa taħt il- ġilda fuq medda ta ’ 24 siegħa jew bħala injezzjoni ta ’ kuljum taħt il- ġilda għal 5 sa 7 ijiem konsekuttivi.
For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Għal l- infużjoni, id- doża ta ’ filgrastim 3 trid tkun miżjuda ma ’ 20ml soluzzjoni ta ’ glucose 50 mg/ ml (5%) (ara sezzjoni 6. 6 għall- istruzzjonijiet fuq id- dilwit).
1 or
Meta għandha ssir l- lewkafereżi: proċedura waħda jew tnejn ta ’ lewkofereżi fil- ħames u sitt jum is- soltu jkunu biżżejjed.
In other circumstances, additional leukaphereses may be necessary.
F’ ċirkostanzi oħrajn, jista jkun hemm bżonn ta ’ aktar lewkofereżi.
Filgrastim dosing should be maintained until the last leukapheresis.
Kura b’ filgrastim irid jitkompla sa l- aħħar proċedura ta ’ lewkafereżi.
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.
Wara kimoterapija majelosoppressiva, id- doża rakkomandata ta ’ filgrastim għall- mobilizzazzjoni ta ’ PBPC hija 0. 5 MIU (5 μg) / kg/ jum mogħtija bħala injezzjoni taħt il- ġilda ta ’ kuljum mill- ewwel ġurnata wara t- tmiem tal- kimoterapija sakemm in- nadir mistenni jkun għadda u l- għadd ta ’ newtrofili jkun reġa ’ lura għan- normal.
Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
Lewkafereżi jrid isir fil- perijodu meta l- ANC jitla ’ minn < 0. 5 x 109/ l sa > 5. 0 x 109/ l.
For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
F’ pazjenti li ma kellhomx kimoterapija estensiva, proċedura waħda ta ’ lewkafereżi is - soltu tkun bizzejjed.
In other circumstances, additional leukaphereses are recommended.
F’ ċirkostanzi oħrajn, jista ’ jkun hemm bżonn ta ’ aktar proċeduri.
For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell transplantation
Għall- mobilizzazzjoni ta ’ PBPC f 'donaturi b’ saħħithom qabel trapjant alloġenejiku ta ’ ċelluli proġenitriċi tad- demm periferali
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.
Għall- mobilizzazzjoni ta ’ PBPC f 'donaturi b’ saħħithom, id- doża ta ’ filgrastim trid tkun 1. 0 MIU (10 μg) / kg/ jum mogħtija taħt il- ġilda għal 4 sa 5 ijiem konsekuttivi.
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.
Il- proċedura ta ’ lewkafereżi trid tibda fil- 5 ġurnata u titkompla sas- 6 ġurnata jekk ikun hemm bżonn sabiex jinġabru 4 x 106 CD34+ celluli għal kull kg ta ’ piż tal- ġisem tar- riċevitur.
In patients with severe chronic neutropenia (SCN)
F’ pazjenti b’ newtropenja kronika u qawwija (SCN)
Congenital neutropenia The recommended starting dose is 1.2 MIU (12 μ g)/ kg/ day subcutaneously as a single dose or in divided doses.
Newtropenja konġenitali Id- doża tal- bidu rakkomandata hi 1. 2 MIU (12 μg) / kg/ jum mogħtija taħt il- ġilda bħala doża waħda jew f’ dożi maqsumin.
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.
Newtropenja idjopatika jew ċiklika Id- doża tal- bidu rakkomandata hi 0. 5 MIU (5 μg) / kg/ jum mogħtija taħt il- ġilda bħala doża waħda jew f’ dożi maqsumin.
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.
Aġġustament fid- doża Filgrastim irid jingħata ta ’ kuljum bħala injezzjoni taħt il- ġilda sakemm l- għadd ta ’ newtrofili jilħaq u jinżamm il- fuq minn 1. 5 x 109/ l.
When the response has been obtained, the minimal effective dose to maintain this level should be established.
Meta dan ir- rispons ikun milħuq, id- doża minima u effettiva sabiex jinżamm dan il- livell trid tiġi stabilita.
Long-term daily administration is required to maintain an adequate neutrophil count.
Amministrazzjoni ta ’ kuljum u fit- tul hu meħtieġ biex jinżamm għadd ta ’ newtrofili adegwat.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Wara gimgħa jew tnejn ta ’ terapija, id- doża tal- bidu tkun tista ’ tiġi rdoppjata jew titniżżel bin- nofs dejjem skond ir- rispons tal- pazjent.
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.
Sussegwentement id- doża tista ’ tiġi aġġustata għal individwu kull gimgħa jew gimgħatejn biex il- medju ta ’ l- għadd ta ’ newtrofili jinżamm bejn 1. 5 x 109/ l u 10 x 109/ l.
A faster schedule of dose escalation may be considered in patients presenting with severe infections.
L- iskeda tad- doża tista ’ tiżdied iktar ta’ spiss f’ pazjenti li jkollhom infezzjonijiet qawwija.
In clinical trials, 97% of patients who responded had a complete response at doses of 2.4 MIU (24 μ g)/ kg/ day.
Fi studji kliniċi, 97% tal- pazjenti li rrispondu kellhom rispons komplet b’ doża ta ’ 2. 4 MIU (24 μg) / kg/ jum.
The long-term safety of filgrastim administration above 2.4 MIU (24 μ g)/ kg/ day in patients with SCN has not been established.
Is- sigurta ’ assoċjat ma ’ l- amministrazzjoni fit- tul ta ’ filgrastim f’ dozi akbar minn 2. 4 MIU (24 μg) / kg/ jum f’ pazjenti b’ SCN għada ma ġietx stabilita.
In patients with HIV infection
F’ pazjenti b’ infezzjoni tal- HIV
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).
Għall- inverżjoni ta ’ newtropenja Id- doża tal- bidu rakkomandata ta ’ filgrastim hija 0. 1 MIU (1 μg) / kg/ jum mogħtija ta ’ kuljum b’ injezzjoni taħt il- ġilda u tiżdied b’ iddozar sa massimu ta ’ 0. 4 MIU (4 μg) / kg/ jum sakemm livell normali fl- għadd ta ’ newtrofili jintlħaq u jista ’ jinżamm (ANC > 2. 0 x109/ l).
In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Fi studji kliniċi, > 90% tal- pazjenti rrispondu b’ dawn id- dożi, u kellhom taqlib ta ’ newtropenja f’ medda ta ’ jumejn.
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.
F’ numru żgħir ta ’ pazjenti (< 10%), kien hemm bżonn ta ’ dożi sa 1. 0 MIU (10 μg) / kg/ jum biex ikollhom taqlib ta ’ newtropenja.
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.
Biex jinżamm għadd ta ’ newtrofili normali Meta sseħħ it- taqlib ta ’ newtropenja, id- doża minima u effettiva li hemm bżonn sabiex jinżamm għadd ta ’ newtrofili normali trid tiġi stabbilita.
Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.
Jista ’
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
4 jkun hemm bżonn ta ’ aktar aġġustament fid- dożaġġ, li trid tiġi iddeterminata mill- ANC tal- pazjent, bl- għan li l- għadd ta ’ newtrofili jinżamm > 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
F’ studji kliniċi, dożaġġ ta’ 30 MIU (300 μg) / jum għal ġurnata sa sebgħat ijiem fil- gimgħa kien meħtieġ biex jinżamm ANC > 2. 0 x 109/ l, bil- frekwenza medja tad- dożaġġ tkun ta ’ tlett ijiem fil- ġimgħa.
Long-term administration may be required to maintain the ANC > 2.0 x 109/ l.
Kura fit- tul tista ’ tkun meħtieġa sabiex l- ANC jinżamm > 2. 0 x 109/ l.
Special populations
Gruppi ta ’ pazjenti speċifiċi
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.
L- anzjani Għalkemm studji kliniċi b’ filgrastim inkludew numru zgħir ta ’ pazjenti anzjani, ma sarux studji speċifiċi fuq dan il- grupp u għaldaqstant ma jistgħux jingħataw rakkomandazzjonijiet speċifiċi ta ’ dożaġġ għall- anzjani.
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.
Pazjenti b’ indeboliment tal- kliewi jew tal- fwied Studji fuq l- użu ta ’ filgrastim f’ pazjenti b’ indeboliment qawwi tal- kliewi jew tal- fwied juru li l- profil farmakokinetiku u farmakodinamiku huwa l- istess bħal dak f’ individwi b’ saħħithom.
Dose adjustment is not required in these circumstances.
M’ hemmx bżonn ta ’ aġġustament tad- doża f’ dawn il- każi.
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.
Użu fil- pedjatrija f’ każ ta ’ SCN u kanċer Ħamsa u sittin fil- mija tal- pazjenti li ġew studjati fil- programm tas- sigurtà ta ’ newtropenja qawwija u kronika kienu taħt it- 18- il sena.
The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
L- effikaċja tal- kura kienet ċara f’ dan il- grupp ta ’ pażjenti, li fih il- maġġoranża kienu pażjenti b’ newtropenja konġenitali.
There were no differences in the safety profiles for paediatric patients treated for severe chronic neutropenia.
Ma kien hemm l- ebda tibdil fil- profili tas- sigurta ’ f’ pazjenti pedjatriċi l fejn ingħatalhom kura għal newtropenja qawwija u kronika.
Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Tagħrif minn studji kliniċi li saru f’ pazjenti pedjatriċi, jindika li l- profili tas- sigurta ’ u l- effikaċja ta ’ filgrastim, f’ adulti u fit- tfal li qed jirċievu kimoterapija ċitotossika, huma simili.
The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Ir- rakkomandazzjonijiet tad- dożaġġ f’ pazjenti pedjatriċi huma l- istess għal dawk f’ adulti li qed jirċievu kimoterapija ċitotossika majelosoppressiva.
Special warnings
Twissijiet speċjali
Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens (see below).
Filgrastim m’ għandux jintuża sabiex id- dożaġġ ta ’ kimoterapija ċitotossika tiżdied iktar minn skedi ta ’ dożaġġ stabbiliti (ara hawn taħt).
Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Filgrastim m’ għandux jintuża f’ pazjenti b’ newtropenja konġenitali qawwija (is- sindromu ta ’ Kostman) b’ abnormalitajiet ċitoġenetiċi (ara hawn taħt).
Special precautions in patients with acute myeloid leukaemia
Prekawzjonijiet speċjali f’ pazjenti b’ lewkimja majelojde akuta
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.
Tumur malinn Il- fattur li jistimola l- kolonji ta ’ granuloċiti jista ’ jippromwovi it- tkabbir ta ’ ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Is- sigurta 'u l- effikaċja ta' filgrastim għadhom ma ġewx stabbiliti f 'pazjenti b' sindromu majelodisplastiku jew lewkimja majeloġenika kronika.
Therefore, filgrastim is not indicated for use in these conditions.
Għalhekk, filgrastim m 'għandux jintuża f' dawn il- pazjenti.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Attenzjoni speċjali għandha tingħata biex tiġi distinta id- djanjożi ta 'tibdil taċ- ċelluli blastiċi ta' lewkimja majelojde kronika minn ta 'lewkimja majelojde akuta.
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
5 Minħabba tagħrif limitat dwar is- sigurta 'u l- effikaċja assoċjat mal- użu f’ pazjenti b’ Lewkimja Majelojde Akuta (AML) sekondarja, filgrastim għandu jingħata b’ kawtela f’ dawn il- każi.
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- sigurta 'u l- effikaċja ta' filgrastim għadhom ma ġewx stabbiliti f 'pazjenti b’ Lewkimja Majelojde Akuta de novo li għandhom inqas minn 55 sena u ċitoġenetiċi normali [t( 8; 21), t( 15; 17), u inv( 16)].
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.
Prekawzjonijiet speċjali oħrajn Jista ’ jkun hemm bżonn ta ’ monitoraġġ tad- densita ta ’ l- għadam f’ pazjenti li jkollhom xi mard ta ’ ostejoporosi u li jinħtieġu kura kontinwa b’ filgrastim għal iktar minn 6 xhur.
Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after G- CSF administration.
Effeti mhux mixtieqa rari tal- pulmun, b 'mod partikulari pulmonite interstizjali, ġew rrapportati wara l- għoti tal- fattur li jistimola l- kolonji ta ’ granuloċiti.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Pazjenti b' każ reċenti ta 'infiltrati pulmonari jew pulmonite jista' jkollhom riskju għola.
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).
Bidu ta ’ sinjali pulmonari bħal sogħla, deni u qtugħ ta ’ nifs flimkien ma ’ sinjali radjuloġiċi ta ’ infiltrati pulmonari u deterjorazzjoni tal- funzjoni tal- pulmun jistgħu jkunu sinjali tal- bidu tas- sindromu tat- tbatija respiratorja fl- adulti (ARDS).
Filgrastim should be discontinued and appropriate treatment given in these cases.
F’ ċirkostanzi bħal dawn filgrastim għandu jitwaqqaf u għandha tingħata l- kura addattata.
Special precautions in cancer patients
Prekawzjonijiet speċjali f’ pazjenti bil- kanċer
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).
Lewkoċitosi Għadd taċ- ċelluli bojod ta ’ 100 x 109 / l jew aktar ġew osservati f’ inqas minn 5% tal- pazjenti li ngħataw filgrastim b’ dożi akbar minn 0. 3 MIU/ kg/ jum (3 μg/ kg/ jum).
No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Ma ġie osservat l- ebda effett mhux mixtieq attribwit direttament għal dan il- grad ta ’ lewkoċitosi.
However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Madankollu, minħabba r- riskji potenzjali li hemm assoċjati ma ’ lewkoċitosi qawwija, l- għadd taċ- ċelluli bojod irid jiġi mkejjel f’ intervalli regolari waqt il- kura b’ filgrastim.
If leukocyte counts exceed 50 x 109/ l after the expected nadir, filgrastim should be discontinued immediately.
Jekk l- għadd ta ’ lewkoċiti taqbeż 50 x 109/ l wara li jkun għadda in- nadir mistenni, il- kura b’ filgrastim trid titwaqqaf minnufih.
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.
Madankollu, waqt il- perijodu ta ’ l- amministrazzjoni ta ’ filgrastim għall- mobilizzazzjoni ta ’ PBPC, kura b’ filgrastim trid jitwaqqaf jew id- doża titniżżel jekk l- għadd ta ’ lewkoċiti titla ’ 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’ dożi għola ta ’ kimoterapija Il- kawtela speċjali trid tiġi eżerċitata f’ kura ta ’ pazjenti li qed jirċievu dożi għola ta ’ kimoterapija għax rispons aħjar tat- tumur ma ġiex stabbilit u dozi aktar qawwija ta ’ sustanzi kimoterapewtiċi jistgħu jwasslu għal tossiċita ’ żejda inkluż diturbi fil- qalb, fil- pulmun, fis- sistema nervuża u fil- ġilda (jekk jogħġbok irreferi għas- Summarju tal- Karatteristiċi tal- Prodott tas- sustanża kimoterapewtika speċifika li tintuża).
Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Kura b’ filgrastim waħdu ma tipprekludix l- iżvilupp ta ’ tromboċitopenja u anemija assoċjat ma ’ 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- possibilita ’ li jirċievi doża għolja ta ’ kimoterapija (ez. id- doża sħiħa ta 'kimoterapija majelosoppressiva fl- iskeda preskritta), il- pazjent jista ’ jkollu riskju għola ta ’ tromboċitopenja u anemija.
Regular monitoring of platelet count and haematocrit is recommended.
Huwa rakkomandat li jsir immonitorjar regolari ta ’ l- għadd tal- plejtlits u l- ematokrit.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Il- kawtela speċjali trid tiġi eżerċitata meta sustanzi kimoterapewtiċi, magħrufin li jistgħu jwasslu għal tromboċitopenja qawwija, jiġu amministrati jew waħidhom inkella flimkien.
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 ta ’ PBPC mobilizzati b’ filgrastim inaqqas il- gravita ’ u t- tul ta ’ tromboċitopenja wara kimoterapija majelosoppressiva jew majeloablativa.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Prekawzjonijiet speċjali oħrajn Ma ġewx studjati l- effetti ta ’ filgrastim f’ pazjenti li għandhom tnaqqis sostanzjali ta ’ ċelluli proġenitriċi majelojdi.
Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Filgrastim jaħdem primarjament fuq il- prekursuri ta ’ newtrofili sabiex jeffettwa ż- zjieda fl- għadd ta ’ 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 li għandhom livell baxx ta ’ prekursuri, ir- rispons ta ’ newtrofili jista ’ jkun mnaqqas (bħal dawk li kellhom kura estensiva b’ radjoterapija jew b’ kimoterapija, jew dawk b’ infiltrazzjoni tat- tumur fil- mudullun).
The effect of filgrastim on graft versus host disease has not been defined.
L- effett ta ’ filgrastim fuq il- mard tal- graft kontra l- ospitu għadu ma giex stabbilit.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
6 Żjieda fl- attività ematopojetika fil- mudullun f' rispons għal terapija ta 'fattur tat- tkabbir ġiet assoċjata ma' sejbiet transitorja posittivi fl- istampi tal- għadam.
This should be considered when interpreting bone-imaging results.
Dan għandu jiġi kkonsidrat meta ir- riżultati ta 'l - istampi ta' l- għadam jiġu nterpretati.
Special precautions in patients undergoing peripheral blood progenitor cell mobilisation
Prekawzjonijiet speċjali f’ pazjenti taħt proċedura ta ’ mobilizzazzjoni ta ’ PBPC
Mobilisation There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient
Mobilizzazzjoni M’ hemmx studju randomised xieraq li jikkompara iż- żewġ metodi rakkomandati ta’ mobilizzazzjoni (filgrastim waħdu jew flimkien ma ’ kimoterapija majelosoppressiva) fl- istess grupp ta ’ pazjenti.
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Minħabba varjazzjoni li hemm bejn pazjenti individwali u d- differenzi li hemm fl- analiżi ta ’ celluli CD34+ fil- laboratorju, il- paragun dirett bejn studji varji huwa diffiċli.
It is therefore difficult to recommend an optimum method.
Għaldaqstant, mhuwiex faċli li jiġi rakkomandat l- aħjar metodu.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
L- għażla tal- metodu ta ’ mobilizzazzjoni trid issir fuq bażi ta ’ l- oġġettivi ġenerali tal- kura li jridu jintlaħqu għal kull pazjent individwali.
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.
Pazjenti li ġew esposti għal aġenti ċitotossiċi Jista ’ jkun li pazjenti li għaddew minn kura majelosoppressiva estensiva ma jkollhomx mobilizzazzjoni suffiċjenti ta ’ PBPC biex jaslu għall- għadd minimu rakkomandat (2. 0 x 106 CD34+ ċelluli/ kg) jew biex l- irkuprar tal- plejtlits jaċċelera bl- istess grad.
Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Xi aġenti ċitotossiċi jesibixxu tossiċita ’ partikolari lejn iċ- ċelluli proġenitriċi ematopojetiċi u jistgħu jkollhom effett avvers fuq il- mobilizzazzjoni taċ- ċelluli proġenitriċi.
Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Aġenti bħal melphalan, carmustine (BCNU) u carboplatin, meta jiġu amministrati għal perijodi twal qabel tentattivi ta ’ mobilizzazzjoni taċ- ċelluli proġenitriċi, jistgħu jirriżultaw f’ numru inqas ta ’ ċelluli proġenitriċi.
However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Madankollu, intwera ’ li l- amministrazzjoni ta ’ melphalan, carboplatin jew BCNU flimkien ma ’ filgrastim kien effettiv fil- mobilizzazzjoni taċ- ċelluli proġenitriċi.
When a peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Meta jkun hemm il- ħsieb ta ’ trapjant ta ’ PBPC, huwa rakkomandat li il- proċedura ta ’ mobilizzazzjoni issir 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 partikolari trid tingħata għan- numru ta ’ ċelluli proġenitriċi mobilizzati f’ dawn il - pazjenti qabel ma tiġi amministrata kimoterapija ta ’ doża għolja.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Jekk il- produzzjoni taċ- ċelluli proġenitriċi ma tkunx biżżejjed, kif imkejla bil- kriterji msemmija hawn fuq, għandha tiġi kkunsidrata kura alternattiva fejn l- għajnuna taċ- ċelluli proġenitriċi ma tkunx meħtieġa.
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.
Analiżi tal- produzzjoni taċ- ċelluli proġenitriċi Meta jitkejjel l- għadd taċ- ċelluli proġenitriċi mobilizzati f’ pazjenti taħt kura b ’ filgrastim, attenzjoni partikolari trid tingħata għal 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 ġejjin minn flow cytometric analysis ta ’ l- għadd taċ- ċelluli CD34+ jistgħu jvarjaw skond il- metodu preċiz li jintuża u għaldaqstant rakkomandazzjonijiet ta ’ numri ibbażati fuq analiżi li saru f’ laboratorji oħrajn għandhom ikunu interpretati bil- qies.
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.
Studju tar- relazzjoni bejn in- numru ta ’ ċelluli CD34+ infużi mill- ġdid u r- rata ta ’ rkuprar tal- plejtlits wara kimoterapija b’ doża għolja jindika relazzjoni statistikament kumpless iżda kontinwu.
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 ’ produzzjoni minima ta ’ 2. 0 x 106 CD34+ ċelluli/ kg hija bbażata fuq tagħrif ta’ esperjenzi ppublikati li irriżultaw f’ rikostituzzjoni ematoloġika adegwata.
Yields in excess of this minimum yield appear to correlate with more rapid recovery, those below with slower recovery.
Produzzjoni ikbar minn dan il- minimu hi marbuta ma ’ rata ta ’ rkuprar malajr, produzzjoni inqas ma ’ rata ta ’ rkuprar iktar bil- mod.
Special precautions in normal donors undergoing peripheral blood progenitor cell mobilisation
Prekawzjonijiet speċjali f’ donaturi b’ saħħithom taħt proċedura ta ’ mobilizzazzjoni ta ’ PBPC
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.
Il- proċedura ta ’ mobilizzazzjoni ta ’ PBPC ma tirriżultax dirretament f’ benefiċju kliniku għal donaturi b’ saħħithom u trid tiġi ikkunsidrata biss f’ każ ta ’ trapjant alloġenejiku ta ’ PBPC.
PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Il- proċedura ta ’ mobilizzazzjoni ta ’ PBPC trid tiġi kkunsidrata biss għal donaturi li jissodisfaw il- kriterji kliniċi u investigattivi kollha għad- donazjoni ta ’ PBPC.
Particular attention should be paid to haematological values and infectious diseases.
Trid issir attenzjoni partikulari lejn il- parametri ematoloġiċi u infezzjonijiet.
The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Is- sigurta ’ u l- effikaċja ta ’ filgrastim ma ġewx investigati f’ donaturi b’ saħħithom < 16- il sena jew > 60 sena.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
7 Wara l- amministrazzjoni ta ’ filgrastim u proċedura ta ’ lewkafereżi, ġiet osservata tromboċitopenja transitorja (plejtlits < 100 x 109/ l) f’ 35% tas- suġġeti li ġew studjati.
Among these, two cases of platelets < 50 x 109/ l were reported and attributed to the leukapheresis procedure.
Fosthom, kien hemm żewġ kazi fejn il- livell ta ’ plejtlits kien < 50 x 109/ l li kien attribwit għall- proċedura ta ’ lewkafereżi.
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 ikun hemm bżonn ta ’ iktar minn proċedura waħda ta ’ lewkafereżi, trid issir attenzjoni partikulari lejn donaturi li għandhom livell ta ’ plejtlits < 100 x 109/ l qabel il- lewkafereżi; bħala regola ġenerali, afereżi m’ għandiex issir jekk il- livell ta ’ plejtlits jkun < 75 x 109/ l.
Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Lewkafereżi m’ għandiex issir f’ donaturi waqt kura b’ antikoagulanti jew f’ dawk li jafu li għandhom disturbi ta ’ l- emostażi.
7 Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/ l.
Il- kura b’ filgrastim trid titwaqqaf jew id- dożaġġ jitnaqqas jekk l- għadd ta ’ lewkoċiti jaqbeż is- 70 x109/ l.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Donaturi li jirċievu kura b’ G- CSF għal mobilizzazzjoni ta ’ PBPC jridu jkunu monitorjati sew sakemm il- parametri ematoloġiċi jergħu lura għan- normal.
Transient cytogenic modifications have been observed in normal donors following G-CSF use.
Bidliet ċitoġeniċi transitorja ġew osservati f’ donaturi b’ saħħithom wara l- użu ta ’ G- CSF.
The significance of these changes in terms of the development of haematological malignancy is unknown.
Ir- rilevanza ta ’ dawn il- bidliet lejn l- iżvillup ta ’ tumur malinn ematoloġiku mhix magħrufa.
Long-term safety follow-up of donors is ongoing.
Studju fit- tul dwar is- sigurta ’ f’ donaturi b’ saħħithom għadu għaddej.
A risk of promotion of a malignant myeloid clone can not be excluded.
Ir- riskju li jwassal għal l- iżvillup ta ’ tumur malinn ma ’ jistax ikun eskluż.
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Huwa rakkomandat li jinżammu rekords sistematiċi tad- donaturi taċ- ċelluli proġentriċi mill- inqas għal għaxar snin fiċ- centru fejn issir l- afereż ta ’ PBPC sabiex ikun assigurat l - monitoraġġ u s- sigurta ’ fit- tul.
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 mingħajr sintomi ta ’ tkabbir tal- milza u każijiet rari ħafna ta ’ milza mifqugħha ġew irrapurtati f’ donaturi b’ saħħithom u f ’ pazjenti wara li ngħataw G- CSF.
Some cases of splenic rupture were fatal.
Ftit każijiet ta ’ milza mifqugħha kienu fatali.
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Għalhekk, id- daqs tal- milza għandu jiġi monitorjat b' attenzjoni (eż. b 'eżaminazzjoni klinika, b' eżami ultrasoniku).
A diagnosis of splenic rupture should be considered in donors and/ or patients reporting left upper abdominal pain or shoulder tip pain.
Dijanjożi ta ’ milza mifqugħha għandha tkun ikkunsidrata f’ donaturi u/ jew f’ pazjenti b’ uġigħ addominali fin- naħa ta ’ fuq tax- xellug jew uġigħ fit- tarf ta ’ l- ispalla.
Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Prekawzjonijiet speċjali f’ reċipjenti ta ’ trapjant alloġenejiku ta ’ PBPC mobilizzati b ’ 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 graft versus host disease when compared with bone marrow transplantation.
Tagħrif kurrenti jindika li r- rejazzjonijiet immunoloġiċi bejn il- graft alloġenejiku ta ’ PBPC u r- reċipjent jistgħu jkunu assoċjati ma ’ riskju għola tal- marda akuta u kronika tal- graft kontra l- ospitu meta kkomparat ma ’ trapjant tal- mudullun.
Special precautions in SCN patients
Prekawzjonijiet speċjali f’ pazjenti B’ SCN
Blood cell counts Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
L- għadd taċ- ċelluli tad- demm L- għadd tal- plejtlits irid ikun monitorjat mill- qrib, speċjalment waqt l- ewwel ġimgħat ta ’ kura 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.
Trid tiġi kkunsidrata il- waqfien intermittenti ta ’ kura jew it- tnaqqis fid- doża ta ’ filgrastim f’ pazjenti li jiżvillupaw tromboċitopenja, i. e. l- għadd tal- plejtlits jkun konsistentement < 100, 000/ mm3.
Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Bidliet oħrajn iseħħu fiċ- ċelluli tad- demm, fosthom anemija u żidiet transitorja fiċ- ċelluli proġenitriċi fil- mudullun, fejn ikun hemm bżonn ta ’ monitoraġġ mill- qrib ta ’ l- għadd taċ- celluli.
Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Trasformazzjoni f’ lewkimja jew sindromu majelodisplastiku Il- kawtela speċjali trid tiġi eżerċitata f’ djanjożi ta 'newtropenja qawwija u kronika biex din tiġi distinta minn disturbi ematopojetiċi oħra bħal anemija aplastika, sindromu majelodisplastiku 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 komplet tad- demm u differenzjali, l- għadd tal- plejtlets, evalwazzjoni tal- morfoloġija tal- mudullun u assay kromoġeniku jrid isir qabel il- bidu tal- kura.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Fi studji kliniċi, kien hemm frewkwenza baxxa (madwar 3%) ta ’ sindromi majelodisplastiċi (MDS) jew lewkimja f’ pazjenti b ’ SCN ikkurati b’ filgrastim.
This observation has only been made in patients with congenital neutropenia.
Din l- osservazzjoni saret biss f’ pazjenti li
MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
MDS u lewkimja huma kumplikazzjonijiet naturalment marbutin mal- marda u r- relazzjoni tagħhom ma ’ kura b’ filgrastim mhijiex ċerta.
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.
Subset ta ’ madwar 12% tal- pazjenti li fil- bidu kellhom parametri ċitoġenetiċi normali, sussegwentement instabu li kellhom abnormalitajiet, fosthom monosomy 7, f’ analiżi li ġew ripetuti perjodikament.
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.
Jekk pazjenti b’ SCNjiżvillupaw parametri ċitoġenetiċi abnormali, għandhom jintiżnu sewwa r- riskji jew il- benefiċji li tissokta il- kura b’ filgrastim; filgrastim irid jitwaqqaf f’ każ ta ’ MDS jew lewkimja.
It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Bħalissa mhuwiex ċert jekk il- kura fit- tul b’ filgrastim f’ pazjenti b’ SCNjippredisponi dan il- grupp ta ’ pazjenti għal parametri ċitoġenetiċi abnormali, MDS jew lewkimja.
It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Huwa rrakkomandat li jsiru investigazzjonijiet morfoloġiċi u ċitoġeniċi tal- mudullun fil- pazjenti b’ intervalli regolari (madwar kull 12- il xahar).
Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Prekawzjonijiet speċjali oħrajn Kawżi oħra ta ’ newtropenja transitorji bħal infezzjonijiet virali għandhom jiġu esklużi.
Splenic enlargement is a direct effect of treatment with filgrastim.
Żjieda fid- daqs tal- milza huwa effett dirett ta ’ kura b ’ filgrastim.
Increases in volume, measured
Mill- pazjenti studjati, wieħed u tletin fil- mija (31%) ġew irrapportati li kellhom żjieda fid- daqs tal- milza li setgħet tinħass fiżikament.
8 radiographically, occurred early during filgrastim therapy and tended to plateau.
Żjidiet fil- volum, imkejla permezz ta ’ evalwazzjoni radjografika, seħħu kmieni fil- bidu ta ’ kura b’ filgrastim u mbagħad laħqu plateau.
Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3% of patients a splenectomy was required.
Kien hemm bżonn ta ’ tnaqqis fid- doża sabiex titnaqqas jew titwaqqaf il- progressjoni taż- żjieda fid- daqs tal- milza u fit- tlieta fil- mija tal- pazjenti kien hemm bżonn li il- milza titneħħa.
Spleen size should be evaluated regularly.
Id- daqs tal- milza trid tkun mkejla regolarment.
Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Eżaminazzjoni fiżika tal- addome tkun biżżejjed biex jitkixxfu żjiediet abnormali fid- daqs tal- milza.
Haematuria/ proteinuria occurred in a small number of patients.
Ematurja/ proteinurja seħħ f’ numru żgħir ta ’ pazjenti.
Regular urinanalysis should be performed to monitor this event.
Għandu jsir analiżi regolari ta ’ l- awrina biex dan jiġi monitorjat.
The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Is- sigurta ’ u l- effikaċja għadhom ma ġewx stabbiliti fit- trabi tat- twelid u f ’ pazjenti b’ newtropenja awto- immunitarja.
Special precautions in patients with HIV infection
Prekawzjonijiet speċjali f’ pazjenti b’ infezzjoni ta ’ l- HIV
Blood cell counts ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
L- għadd taċ- ċelluli tad- demm l- Għadd Assolut ta ’ Newtrofili (ANC) għandu jiġi monitorjat b’ attenzjoni, speċjalment waqt l- ewwel ftit ġimgħat ta ’ kura 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 ta ’ newtrofili, għad- doża inizjali ta’ filgrastim.
It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Huwa rakkomandat illi l- ANC jiġi mkejjel kuljum għal l- ewwel jumejn sa tlett ijiem ta ’ amministrazzjoni b’ filgrastim.
Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Minn hemm il- quddiem, huwa rakkomandat illi l- ANC jiġi mkejjel mill- inqas darbtejn fil- ġimgħa għal l- ewwel gimgħatejn, u sussegwentement, darba kull gimgħatejnwaqt il- manteniment tal- kura.
During intermittent dosing with 30 MIU (300 μ g)/ day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Waqt kura intermittenti b’ dożi ta ’ 30 MIU (300 μg) / jum ta ’ filgrastim, l- ANC tal- pazjent jista ’ jitbiddel b’ mod notevoli maż- 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 jiġi stabbilit il- punt l- aktar baxx jew in- nadir fil- livell tal- ANC f’ pazjent, huwa rakkomandat illi l- kampjuni tad- demm meħudin biex jitkejjel l- ANC jittieħdu eżatt qabel id- doża skedata ta ’ filgrastim.
Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Riskju assoċjat ma ’ dożi miżjuda ta ’ prodotti mediċinali majelosoppressivi Kura b’ filgrastim waħdu ma ’ jipprekludix l- iżvilupp ta ’ tromboċitopenja u anemija assoċjati ma ’ l- użu ta ’ prodotti mediċinali majelosoppressivi.
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.
B’ Rizultat li hemm potenzjal li jirċievi dożi akbar u iktar spiss ta ’ dawn il- prodotti waqt kura b’ filgrastim, jista ’ jkun hemm riskju għola li l- pazjent jiżviluppa tromboċitopenja u anemija.
Regular monitoring of blood counts is recommended (see above).
Huwa rakkomandat li l- għadd taċ- ċelluli tad- demm jiġi monitorjat regolarment (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.
Majelosuppressjoni minħabba infezzjonijiet u mard malinn Newtropenja tista ’ tkun kawżata minn infezzjonijiet opportunistiċi li jinfiltraw il- mudullun bħal m’ hu l- kumpless relatat ma ’ Mycobacterium avium jew mard malinn 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 fejn hemm konferma ta ’ infezzjonijiet li jinfiltraw il- mudullun jew mard malinn, wieħed għandu jikkunsidra li tingħata kura addattata għal din il- kundizzjoni flimkien ma ’ l- amministrazzjoni 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 assoċjat ma ’ infezzjonijiet li jinfiltraw il - mudullun jew mard malinn għadhom ma ġewx stabbiliti.
Special precautions in sickle cell disease
9 Prekawzjonijiet speċjali f’ pazjenti bil- marda taċ- ċelluli Sickle
Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell disease.
Każijiet ta ’ kriżi tal- marda taċ- ċelluli Sickle, ftit minnhom fatali, ġew irrapurtati meta filgrastim intuża f’ pazjenti bil- 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.
Tobba jridu jkunu kawti ħafna, meta jikkunsidraw l- użu ta ’ filgrastim f’ pazjenti bil- marda taċ- ċelluli Sickle u dan biss wara li jitqiesu sewwa r- riskji potenzjali u l - benefiċċji.
Excipients
Sustanzi mhux attivi:
Biograstim contains sorbitol.
Biograstim 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 jieħdu din il- mediċina.
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 affarjiet 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- sigurta ’ u l- effikaċja ta ’ filgrastim, meta jingħata fl- istess ġurnata ma ’ kimoterapija majelosoppressiva ċitotossika, għadhom ma ġewx stabbiliti definitivament.
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- sensittivita` potenzjali għall- kimoterapija majelosoppressiva ċitotossika taċ- ċelluli majelojdi li qed jiddividu malajr, filgrastim m’ għandux jingħata bejn l- 24 siegħa qabel u l- 24 siegħa wara li tingħata 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, li ġej minn studju f’ numru żgħir ta’ pazjenti li ngħataw filgrastim flimkien ma ’ 5- Fluorouracil, juri li tista ’ tiżdied is- severita ’ ta ’ newtropenja.
9 Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
L- interazzjonijiet possibbli ma ’ fatturi ta ’ tkabbir ematopojetiċi u ċitokini għadhom ma ġewx investigati speċifikament fi studji kliniċi.
Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Peress li lithium jippromwovi il- ħelsien ta ’ newtrofili, huwa mistenni li jġib żjieda fl- 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 ġietx speċifikament investigata, m’ hemm l- ebda evidenza li interazzjoni bħal din tista ’ tkun ta ’ ħsara.
There are no adequate data from the use of filgrastim in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ filgrastim f’ nisa 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 li filgrastim jgħaddi mill- plaċenta fin- nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq l- annimali urew ħsara fuq is- sistema riproduttiva (ara 5. 3).
The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq in- nies.
Filgrastim should not be used during pregnancy unless clearly necessary.
Filgrastim m’ għandux jintuża waqt it- tqala jekk m’ hemmx il- bżonn ċar.
It is unknown whether filgrastim is excreted in human breast milk.
Mhux magħruf jekk filgrastim jitneħħix fil- ħalib tal- bniedem.
The excretion of filgrastim in milk has not been studied in animals.
It- tneħħija ta ’ filgrastim fil- ħalib ma ġietx studjata fuq l- annimali.