qanastek/EMEA-V3 huggingface dataset:
In some SCN patients filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia already prior to treatment.
F’ xi pazjenti b’ SCN, filgrastim jista ’ jikkaġuna wkoll żieda żgħira fin- numru ta ’ eosinofili u basofili li jkunu jiċċirkolaw meta mqabbel mal- linja bażi; xi wħud minn dawn il- pazjenti jista ’ jkollhom diġà eosinofilja jew basofilja qabel il- kura.
Elevations of neutrophil counts are dose-dependent at recommended doses.
Iż- żidiet fl- għadd tan- newtrofili jiddependu fuq id- doża fid- dożi rakkomandati.
Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
In- newtrofili prodotti b’ rispons għal filgrastim juru funzjoni normali jew imtejba kif muri minn testijiet tal- funzjoni kemotattika u fagoċitika.
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Wara t- tmiem tat- terapija b’ filgrastim, l- għadd tan - newtrofili li jkunu jiċċirkolaw jonqos b’ 50% fi żmien minn jum sa jumejn, u għal- livelli normali żmien 1 - 7 ijiem.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells, which have specific receptors for G-CSF.
Bħal ma jiġri fil- każ ta ’ fatturi tat- tkabbir ematopojetiċi oħrajn, G- CSF wera proprjetajiet li jistimulaw in vitro fuq ċelluli endoteljali umani, li għandhom riċetturi speċifiċi għal G- CSF.
Accordingly, G-CSF has been shown to induce endothelial cell functions related to angiogenesis.
Għaldaqstant, intwera li G- CSF jikkaġuna funzjonijiet taċ- ċelluli endoteljali marbuta mal - anġjoġenesi.
Additionally, G-CSF has been shown to increase neutrophil migration across the vascular endothelium.
Flimkien ma ’ dan, intwera li G- CSF iżid il- migrazzjoni tan- newtrofili minn naħa għall - oħra tal- endothelium vaskulari.
Use of filgrastim in patients undergoing cytotoxic chemotherapy leads to significant reductions in the incidence, severity and duration of neutropenia and febrile neutropenia.
L- użu ta ’ filgrastim f’ pazjenti li jkunu qed jirċievu kimoterapija ċitotossika jwassal għal tnaqqis sinifikanti fl- inċidenza, is- severità u t- tul ta ’ żmien ta ’ newtropenja u newtropenja bid- deni.
Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Il- kura b’ filgrastim tnaqqas b’ mod sinifikanti it- tul ta ’ żmien kemm iddum in- newtropenja bid- deni, l- użu tal - antibijotiċi u ż- żmien li wieħed idum l- isptar wara l- kimoterapija tal- induzzjoni għal lewkimja majeloġena akuta jew terapija majeloablattiva segwita minn trapjant tal- mudullun.
The incidence of fever and documented infections were not reduced in either setting.
L- inċidenza ta ’ deni u infezzjonijiet dokumentati ma tnaqqsux fl- ebda setting minn dawn.
The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
It- tul ta ’ żmien tad- deni ma tnaqqasx f’ pazjenti li kien qed ikollhom terapija majeloablattiva segwita minn trapjant tal- mudullun.
Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
L- użu ta ’ filgrastim, jew waħdu, jew wara l- kimoterapija, jimmobilizza ċ- ċelluli ematopojetiċi proġenituri fid- demm periferali.
These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of, or in addition to bone marrow transplantation.
Dawn il- PBPCs awtologi jistgħu jinġabru u jingħataw bħala infużjoni wara terapija ċitotossika b’ doża għolja, jew minflok, jew flimkien mat- trapjant tal- mudullun.
Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
L - infużjoni tal- PBPCs taċċelera l- irkuprar ematopojetiku u tnaqqas it- tul ta ’ żmien ta ’ riskju għal kumplikazzjonijiet emorraġiċi u l- ħtieġa għal trasfużjonijiet tal- plejtlits.
13 One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
13 Studju retrospettiv Ewropew li evalwa l- użu ta ’ G- CSF wara trapjant alloġeneiku tal- mudullun f’ pazjenti b’ lewkimji akuti, issuġġerixxa żieda fir- riskju ta ’ GvHD, mortalità marbuta mal- kura (TRM) u l- mortalità meta ngħata G- CSF.
In a separate retrospective international study in patients with acute and chronic myelogenous leukaemias, no effect on the risk of GvHD, TRM and mortality was seen.
Fi studju retrospettiv internazzjonali separat li sar fuq pazjenti b’ lewkimji akuti u majeloġeni kroniċi, ma kien osservat l- ebda effett fuq ir- riskju ta ’ GvHD, TRM u l- mortalità.
A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Meta- analiżi ta ’ studji fuq trapjanti alloġeneiċi, li tinkludi r- riżultati ta ’ disa ’ provi prospettivi randomized, 8 studji retrospettivi u każ 1 ta ’ studju kkontrollat mill- każ, ma sabet l- ebda effett fuq ir- riskji ta ’ GvHD akuta, GvHD kronika jew mortalità relatata mal- kura bikrija.
Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation
Riskju Relattiv (95% CI) ta ’ GvHD u TRM Wara l- kura b’ G- CSF wara trapjant tal- mudullun GvHD akuta
Period of
Perjodu tal -
Acute Grade Chronic
GvHD
Publication
Pubblikazzjoni
Study
Istudju
II - IV GvHD GvHD
ta ’ grad II - IV
Meta-Analysis
Meta- Analiżi
(2003) European
(2003) Retrospettiva
(0.87, 1.33) (0.82, 1.26)
(0. 87, 1. 33)
(0.38, 1.31)
(0. 82, 1. 26)
Retrospective
(0. 38, 1. 31)
1.33 1.29
Ewropea
(1.08, 1.64) (1.02, 1.61)
(1. 02, 1. 61)
(1.30, 2.32)
(1. 30, 2. 32)
Retrospective
Internazzjonali
1.11 1.10
1. 10
Study (2006) a
Studju (2006) a
(0.86, 1.42) (0.86, 1.39)
(0. 86, 1. 39)
(0.95, 1.67)
(0. 95, 1. 67)
Analysis includes studies involving BM transplant during this period; some studies used GM-CSF b Analysis includes patients receiving BM transplant during this period
L- analiżi tinkludi studji li jinvolvu trapjant tal- mudullun matul dan il- perjodu; xi studji użaw GM- CSF b L- analiżi tinkludi pazjenti li kienu qed jirċievu trapjant tal- mudullun matul dan il- perjodu
Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation In normal donors, a 1 MU/ kg/ day (10 μ g/ kg/ day) dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/ kg recipient BW in the majority of the donors after two leukaphereses.
L- użu ta ’ filgrastim għall- mobilizzazzjoni tal- PBPCs f’ donaturi normali qabel it- trapjant alloġeneiku tal- PBPC F’ donaturi normali, doża ta ’ 1 MU/ kg/ kuljum (10 μg/ kg/ kuljum) mogħtija taħt il- ġilda għal 4 - 5 ijiem konsekuttivi, tippermetti l- ġbir ta ’ ≥ 4 x 106 CD34+ ċelluli/ kg piż tal- ġisem tar- reċipjent fil - maġġoranza tad- donaturi wara żewġ lewkaferesi.
Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery when compared with allogeneic bone marrow transplantation.
Ir- reċipjenti tal- PBPCs alloġeneiċi immobilizzati b’ filgrastim, kellhom irkuprar ematoloġiku li kien iktar mgħaġġel b’ mod sinifikanti, li wassal għal tnaqqis sinifikanti fiż- żmien għal irkuprar mhux appoġġjat tal- plejtlits meta mqabbel ma ’ trapjant alloġeneiku tal- mudullun.
Use of filgrastim in children or adults with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ACNs in peripheral blood and a reduction of infection and related events.
L- użu ta ’ filgrastim fit- tfal jew adulti b’ SCN (newtropenja konġenitali severa, ċiklika, u idjopatika) jikkaġuna żieda sostnuta fl- ACNs fid- demm periferali u tnaqqis fl- infezzjoni u avvenimenti relatati.
Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive treatments.
L- użu ta ’ filgrastim f’ pazjenti b’ infezzjoni tal- HIV iżomm l- għadd ta ’ newtrofili f’ livell normali biex jippermetti d- dożaġġ skedat ta ’ kuri antivirali u/ jew ta ’ kuri majelsoppressivi oħrajn.
There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
M’ hemm l- ebda evidenza li pazjenti b’ infezzjoni bl- HIV kkurati b’ filgrastim juru żieda fir- replikazzjoni tal- HIV.
Randomised, double-blind, single and multiple dose, crossover studies in 146 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
Studji crossover, randomised, double- blind, dwar dożi waħidhom u dożi multipli li saru fuq 146 voluntiera b’ saħħithom, urew li l- profil farmakokinetiku ta ’ Filgrastim HEXAL kien komparabbli ma ’ dak tal- prodott tar- referenza wara l- għoti taħt il- ġilda u l- għoti ġol- vini.
A single subcutaneous dose of 0.5 MU/ kg (5 µg/ kg) resulted in maximum serum concentrations after a tmax of 4.5 ± 0.9 hours (mean ± SD).
Doża waħda taħt il- ġilda ta ’ 0. 5 MU/ kg (5 µg/ kg) irriżultat f’ konċentrazzjonijiet massimi fis- serum wara tmax ta ’ 4. 5 ± 0. 9 sigħat (medja ± SD).
The volume of distribution in blood is approximately 150 ml/ kg.
Il- volum tad- distribuzzjoni fid- demm hu ta ’ madwar 150 ml/ kg.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 - 16 hours.
Hemm
There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
14 korrelazzjoni lineari pożittiva bejn id- doża u l- konċentrazzjoni fis- serum ta ’ filgrastim, kemm jekk jingħata ġol- vina jew taħt il- ġilda.
14 Elimination
Eliminazzjoni
The elimination of filgrastim is non-linear with respect to dose, the serum clearance decreases with increasing dose.
L- eliminazzjoni ta ’ filgrastim hi non- lineari fir- rigward tad- doża, it- tneħħija mis- serum tonqos ma ’ żieda fid- doża.
Filgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Filgrastim jidher li jiġi eliminat primarjament mit- tneħħija medjata tan- newtrofili, li jsiru saturati f’ dożi ogħla.
However, the serum clearance increases with repeated dosing while the neutrophil count increases.
Madankollu, it- tneħħija mis- serum tiżdied ma ’ dożaġġ ripetut filwaqt li l - għadd tan- newtrofili jiżdied.
The median serum elimination half-life (t1/ 2) of filgrastim after single subcutaneous doses ranged from 2.7 hours (1.0 MU/ kg, 10 µg/ kg) to 5.7 hours (0.25 MU/ kg, 2.5 µg/ kg) and was prolonged after 7 days of dosing to 8.5 - 14 hours, respectively.
Il- medjan tal- half- life (t1/ 2) tal- eliminazzjoni apparenti ta ’ filgrastim fis - serum wara dożi waħidhom varja minn 2. 7 sigħat (1. 0 MU/ kg, 10 µg/ kg) sa 5. 7 sigħat (0. 25 MU/ kg, 2. 5 µg/ kg) u twal wara 7 ijiem ta ’ dożaġġ għal 8. 5 - 14- il siegħa, rispettivament.
Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable elimination half-lives.
Infużjoni kontinwa b’ filgrastim fuq perjodu sa 28 jum, f’ pazjenti li jkunu qed jirkupraw minn trapjant awtologu tal- mudullun, ma rriżultat fl- ebda evidenza ta ’ akkumulazzjoni tal- mediċina u tal- half- lives tal- eliminazzjoni komparabbli.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
M’ hemm l- ebda dejta ta ’ qabel l- użu kliniku li hi ta ’ rilevanza għal min qed jagħti r- riċetta, li hi addizzjonali ma ’ dik diġà inkluża f’ sezzjonijiet oħrajn tas- Sommarju tal- Karatteristiċi tal- Prodott.
Glutamic acid Sorbitol (E420) Polysorbate 80 Water for injections
Glutamic acid Sorbitol (E420) Polysorbate 80 Ilma għall- injezzjonijiet
Filgrastim HEXAL must not be diluted with sodium chloride solutions.
Filgrastim HEXAL m’ għandux jiġi dilwit b’ soluzzjonijiet ta ’ sodium chloride.
Diluted filgrastim may be adsorbed to glass and plastic materials, unless it is diluted in glucose 50 mg/ ml (5%) solution (see section 6.6).
Filgrastim dilwit jista ’ jkun adsorbit mal- ħġieġ u materjali tal- plastik, ħlief jekk ikun dilwit f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose (ara sezzjoni 6. 6).
After dilution:
Wara d- dilwizzjoni:
Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C.
L- istabbiltà kimika u fiżika waqt l- użu tas- soluzzjoni dilwita għall- infużjoni ntweriet għal 24 siegħa f’ temperatura ta ’ bejn 2°C sa 8°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l - kundizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà tal- utent, u normalment ma jkunux itwal minn 24 siegħa f’ temperatura ta ’ 2°C sa 8°C, ħlief jekk id- dilwizzjoni ma tkunx saret f’ kundizzjonijiet asettiċi kkontrollati u vvalidati.
15 6.5 Nature and contents of container
15 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution.
Siringa mimlija għal- lest (ħġieġ ta ’ tip I) b’ labra tal- injezzjoni (azzar li ma jsaddadx), bi jew mingħajr protezzjoni tas- sigurtà tal- labra, li fiha 0. 5 ml soluzzjoni.
Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Daqsijiet tal- pakkett ta ’ 1, 3, 5 jew 10 siringi mimlija għal- lest.
The solution should be visually inspected prior to use.
Is- soluzzjoni għandha tiġi eżaminata viżwalment qabel l- użu.
Only clear solutions without particles should be used.
Għandhom jintużaw biss soluzzjonijiet li jkunu ċari u mingħajr partikuli.
Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim HEXAL.
L- espożizzjoni aċċidentali għal temperaturi taħt iż- żero mhux ser taffettwa b’ mod negattiv l- istabbiltà ta ’ Filgrastim HEXAL.
In view of the possible risk of microbial contamination, Filgrastim HEXAL syringes are for single use only.
Minħabba r- riskju possibbli ta ’ kontaminazzjoni mikrobjali, is- siringi b’ Filgrastim HEXAL jintużaw darba biss.
Dilution prior to administration (optional)
Dilwizzjoni qabel l- għoti (mhux tabilfors)
If required, Filgrastim HEXAL may be diluted in glucose 50 mg/ ml (5%) solution.
Jekk ikun meħtieġ, Filgrastim HEXAL jista ’ jiġi dilwit f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose.
Dilution to a final concentration < 0.2 MU/ ml (2 μ g/ ml) is not recommended at any time.
Id- dilwizzjoni għal konċentrazzjoni finali ta ’ < 0. 2 MU/ ml (2 μg/ ml) mhijiex rakkomandata fi kwalunkwe ħin.
For patients treated with filgrastim diluted to concentrations < 1.5 MU/ ml (15 μ g/ ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ ml.
Għal pazjenti kkurati b’ filgrastim dilwit għal konċentrazzjonijiet ta ’ < 1. 5 MU/ ml (15 μg/ ml), l - albumina tas- serum uman (HSA) għandha tiġi miżjuda għal konċentrazzjoni finali ta ’ 2 mg/ ml.
In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 μ g) should be given with 0.2 ml of human serum albumin 200 mg/ ml (20%) solution Ph.
F’ volum finali 20 ml, dożi totali ta ’ filgrastim inqas minn 30 MU (300 μg) għandhom jingħataw ma ’ soluzzjoni ta ’ 0. 2 ml ta ’ albumina tas- serum uman (Ph.
Eur. added.
Eur.) 200 mg/ ml (20%).
When diluted in glucose 50 mg/ ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Meta jkun dilwit f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose, filgrastim hu kompatibbli mal- ħġieġ u ma ’ varjetà ta ’ plastiks li jinkludu polyvinylchloride, polyolefin (copolymer ta ’ polypropylene u polyethylene) u polypropylene.
Using the pre-filled syringe with a needle safety guard
Kif tuża s- siringa mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra
The needle safety guard covers the needle after injection to prevent needle stick injury.
Il- protezzjoni tas- sigurtà tal- labra tgħatti l- labra biex jiġi evitat korriment ikkawżat mit- tingiż tal- labra.
This does not affect normal operation of the syringe.
Dan ma jaffettwax l- operat normali tas- siringa.
Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Agħfas il- planġer bil- mod u b’ mod konsistenti sakemm id- doża kollha tkun ingħatat u l- planġer ma jkunx jista ’ jingħafas iktar.
While maintaining pressure on the plunger, remove the syringe from the patient.
Filwaqt li tkompli tagħfas il- planġer, neħħi s- siringa mill- pazjent.
The needle safety guard will cover the needle when releasing the plunger.
Il- protezzjoni tas- sigurtà tal- labra ser tgħatti l- labra meta terħi l- planġer.
Using the pre-filled syringe without a needle safety guard
Kif tuża s- siringa mimlija għal- lest mingħajr protezzjoni tas- sigurtà tal- labra
Administer the dose as per standard protocol.
Agħti d- doża skont il- protokoll standard.
Disposal
Rimi
HEXAL AG Industriestrasse 25 D-83607 Holzkirchen Germany
HEXAL AG Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TAL- AWTORIZZAZZJONI
Filgrastim HEXAL 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe
Filgrastim HEXAL 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest
Each ml of solution contains 96 million units (MU) [equivalent to 960 micrograms (μ g)] filgrastim*.
Kull ml ta ’ soluzzjoni fih 96 miljun unità (MU) [ekwivalenti għal 960 mikrogramma (μg)] ta ’ filgrastim *.
Each pre-filled syringe contains 48 MU (equivalent to 480 μ g) filgrastim in 0.5 ml.
Kull siringa mimlija għal- lest fiha 48 MU (ekwivalenti għal 480 μg) ta ’ filgrastim f’ 0. 5 ml.
18 The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
18 Il- proċeduri tal- mobilizzazzjoni u l- aferesi għandhom jitwettqu b’ kollaborazzjoni ma ’ ċentru tal - onkoloġija- ematolġija b’ esperjenza aċċettabbli f’ dan il- qasam u fejn il- monitoraġġ taċ- ċelluli ematopojetiċi proġenituri jkun jista ’ jitwettaq b’ mod korrett.
Filgrastim HEXAL is available in strengths of 30 MU/ 0.5 ml and 48 MU/ 0.5 ml.
Filgrastim HEXAL hu disponibbli fil- qawwiet ta ’ 30 MU/ 0. 5 ml u 48 MU/ 0. 5 ml.
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
Waqqaf filgrastim għal 3 ijiem konsekuttivi iktar 9 Jekk l- ANC jonqos għal < 1. 0 x 10 / l matul il- perjodu tal- kura, id- doża ta ’ filgrastim għandha tiżdied mill- ġdid skont il- passi t’ hawn fuq
There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient population.
19 M’ hemm l- ebda paraguni prospettivi randomised taż- żewġ metodi tal- mobilizzazzjoni rakkomandata (filgrastim waħdu jew flimkien mal- kimoterapija majelosoppressiva) fl- istess popolazzjoni ta ’ pazjenti.
19 CD34+ cells means that direct comparison between different studies is difficult.
Għalhekk hu diffiċli li tirrakkomanda l - aħjar metodu.
Special populations
20 Popolazzjonijiet speċjali
20 Paediatric patients in the SCN and cancer settings In clinical studies 65% of patients treated for SCN were younger than 18 years.
Pazjenti pedjatriċi li għandhom SCN u kanċer Fi studji kliniċi 65% ta ’ pazjenti kkurati għal SCN kellhom inqas minn 18- il sena.
4.4 Special warnings and precautions for use
21 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
21 Filgrastim should not be administered to patients with severe congenital neutropenia (Kostmann's syndrome) with abnormal cytogenetics (see below).
Filgrastim m’ għandux jingħata lil pazjenti b’ newtropenja severa konġenitali (is- sindrome ta ’ Kostmann) b’ ċitoġeniċi anormali (ara hawn taħt).
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 ’
22 Mobilisation of PBPC
22 jitnaqqas (bħal dawk ikkurati b’ radjuterapija jew kimoterapija estensivi, jew dawk b’ infiltrazzjoni tal - mudullun mit- tumur).
Filgrastim administration should be discontinued or its posology should be reduced if the leukocyte counts rise to > 70 x 109/ l.
23 L- għoti ta ’ filgrastim għandu jitwaqqaf jew il- pożoloġija tiegħu titnaqqas jekk l- għadd tal- lewkoċiti jiżdied għal > 70 x 109/ l.
Long-term safety follow-up of donors is ongoing.
Il- follow- up tas- sigurtà fit- tul tad- donaturi għadha għaddejja.
23 malignant myeloid clone can not be excluded.
Madankollu, ma jistax jiġi eskluż riskju ta ’ promozzjoni ta ’ klonu majelojde malinn.
Other special precautions Causes of transient neutropenia, such as viral infections should be excluded.
24 Prekawzjonijiet speċjali oħrajn Il- kawżi ta ’ newtropenja temporanja, bħal infezzjonijiet virali, għandhom jiġu esklużi.
Increases in volume, measured radiographically, occurred early during Filgrastim therapy and tended to plateau.
Żidiet fil- volum, imkejla b’ mod radjografiku, seħħew kmieni matul it- terapija b’ Filgrastim u kellhom tendenza li jistabbilizzaw.
Dose reductions were noted to slow or stop the progression of splenic enlargement, and in 3% of patients a splenectomy was required.
Kien osservat li tnaqqis fid- doża jnaqqas jew iwaqqaf il- progressjoni ta ’ tkabbir tal- milsa, u fi 3% tal - pazjenti, splenektomija kienet meħtieġa.
24 Haematuria/ proteinuria occurred in a small number of patients.
Ematurja/ proteinuria seħħet f’ numru żgħir ta ’ pazjenti.
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.
25 f’ pazjenti bil- marda taċ- ċelluli sickle, u għandhom jagħmlu dan biss wara evalwazzjoni bir- reqqa tar - riskji u l- benefiċċji potenzjali.
25 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
26 Table 1.
26 Tabella 1.
28 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 - 28 lewkimja, kundizzjoni magħrufa li hi assoċjata mas- sindrome ta ’ Sweet, relazzjoni kawżali ma ’ filgrastim ma kinitx stabbilita.
29 One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
29 Studju retrospettiv Ewropew li evalwa l- użu ta ’ G- CSF wara trapjant alloġeneiku tal- mudullun f’ pazjenti b’ lewkimji akuti, issuġġerixxa żieda fir- riskju ta ’ GvHD, mortalità marbuta mal- kura (TRM) u l- mortalità meta ngħata G- CSF.
1995 - 2000b
1995 – 2000
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 - 16 hours.
Wara l- għoti taħt il- ġilda tad- dożi rakkomandati, il- konċentrazzjonijiet fis- serum inżammu fuq 10 ng/ ml għal 8 - 16- il siegħa.
There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Hemm
30 Elimination
30 korrelazzjoni lineari pożittiva bejn id- doża u l- konċentrazzjoni fis- serum ta ’ filgrastim, kemm jekk jingħata ġol- vina jew taħt il- ġilda.
31 6.5 Nature and contents of container
31 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer(s) of the biological active substance
Isem u indirizz tal- manifattur( i) tas- sustanza bijoloġika attiva
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 6250 Kundl L- Awstrija
Sandoz GmbH Biochemiestrasse 10 AT-6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 AT- 6250 Kundl L- Awstrija
Summary of Product Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
The MAH must ensure that the system of pharmacovigilance, as described in version 7.0, dated 1 July 2008, presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur tal- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 7. 0, bid- data tal- 1 ta ’ Lulju, 2008, ippreżentata f’ Modulu 1. 8. 1. tad- Detentur tal - Awtorizzazzjoni tal- Manifattura, tkun implimentata u taħdem qabel ma l- prodott jibda jinbiegħ.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0, dated 20 October 2008, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur tal- Awtorizzazzjoni tal- Manifattura jrid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 4. 0 bid- data tal- 20 ta ’ Ottubru, 2008, tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2 tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifikazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju.
35 • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
35 • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
36 ANNEX III
36 ANNESS III
OUTER CARTON – PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST
Each pre-filled syringe contains 30 million units (equivalent to 300 micrograms) filgrastim in 0.5 ml (60 MU/ ml).
Kull siringa mimlija għal- lest fiha 30 miljun unità (ekwivalenti għal 300 mikrogramma) ta ’ filgrastim f’ 0. 5 ml (60 MU/ ml).
Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420) - see the package leaflet for further information.
Sustanzi mhux attivi: glutamic acid, polysorbate 80, ilma għall- injezzjonijiet u sorbitol (E420) - ara l - fuljett fil- pakkett għal aktar tagħrif.
1 pre-filled syringe 3 pre-filled syringes 5 pre-filled syringes 10 pre-filled syringes
1 siringa mimlija għal- lest 3 siringi mimlija għal- lest 5 siringi mimlija għal- lest 10 siringi mimlija għal- lest
Single use only.
Jintuża darba biss.
Subcutaneous or intravenous use.
Użu għal taħt il- ġilda jew ġol- vini.
EXP After dilution use within 24 hours.
EXP Wara d- dilwizzjoni, uża fi żmien 24 siegħa.
EU/ 0/ 00/ 000/ 001 – pack of 1 EU/ 0/ 00/ 000/ 002 – pack of 3 EU/ 0/ 00/ 000/ 003 – pack of 5 EU/ 0/ 00/ 000/ 004 – pack of 10
EU/ 0/ 00/ 000/ 001 – pakkett ta ’ 1 EU/ 0/ 00/ 000/ 002 – pakkett ta ’ 3 EU/ 0/ 00/ 000/ 003 – pakkett ta ’ 5 EU/ 0/ 00/ 000/ 004 – pakkett ta ’ 10
Filgrastim HEXAL 30 MU/ 0.5 ml
Filgrastim HEXAL 30 MU/ 0. 5 ml
Each pre-filled syringe contains 48 million units (equivalent to 480 micrograms) filgrastim in 0.5 ml (96 MU/ ml).
Kull siringa mimlija għal- lest fiha 48 miljun unità (ekwivalenti għal 480 mikrogramma) ta ’ filgrastim f’ 0. 5 ml (96 MU/ ml).
Filgrastim HEXAL 48 MU/ 0.5 ml
Filgrastim HEXAL 48 MU/ 0. 5 ml
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST BI PROTEZZJONI TAS - SIGURTÀ TAL- LABRA
1 pre-filled syringe with a needle safety guard 3 pre-filled syringes with a needle safety guard 5 pre-filled syringes with a needle safety guard 10 pre-filled syringes with a needle safety guard
1 siringa mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra 3 siringi mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra 5 siringi mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra 10 siringi mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER PACK WITH PRE-FILLED SYRINGE / PRE-FILLED SYRINGE WITH NEEDLE SAFETY GUARD
PAKKETT BIL- FOLJI B’ SIRINGA MIMLIJA GĦAL- LEST / SIRINGA MIMLIJA GĦAL - LEST BI PROTEZZJONI TAS- SIGURTÀ TAL- LABRA
Filgrastim HEXAL 30 MU/ 0.5 ml injection or infusion
Filgrastim HEXAL 30 MU/ 0. 5 ml injezzjoni jew infużjoni
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Filgrastim HEXAL 48 MU/ 0.5 ml injection or infusion
Filgrastim HEXAL 48 MU/ 0. 5 ml injezzjoni jew infużjoni
48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE / PRE-FILLED SYRINGE WITH A NEEDLE SAFETY GUARD
SIRINGA MIMLIJA GĦAL- LEST / SIRINGA MIMLIJA GĦAL- LEST BI PROTEZZJONI TAS- SIGURTÀ TAL- LABRA
Filgrastim HEXAL 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim HEXAL 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Filgrastim HEXAL 30 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest Filgrastim HEXAL 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest Filgrastim
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek.
What Filgrastim HEXAL is and what it is used for 2.
X’ inhu Filgrastim HEXAL u għalxiex jintuża 2.
Before you use Filgrastim HEXAL 3.
Qabel ma tuża Filgrastim HEXAL 3.
How to use Filgrastim HEXAL 4.
Kif għandek tuża Filgrastim HEXAL 4.
How to store Filgrastim HEXAL 6.
Kif taħżen Filgrastim HEXAL 6.
WHAT FILGRASTIM HEXAL IS AND WHAT IT IS USED FOR
X’ INHU FILGRASTIM HEXAL U GĦALXIEX JINTUŻA
Filgrastim HEXAL contains the active substance filgrastim.
Filgrastim HEXAL fih is- sustanza attiva filgrastim.
It belongs to a group of proteins called cytokines, and is very similar to the granulocyte-colony stimulating factor (G-CSF) produced by the human body.
Jappartjeni għal grupp ta ’ proteini msejħa cytokines, u hu simili ħafna għall- fattur tal- istimulazzjoni tal- kolonji tal- granuloċiti (G- CSF) magħmul mill- ġisem uman.
Filgrastim stimulates the bone marrow to produce more white blood cells that help fight infection.
Filgrastim jistimula l- mudullun biex jipproduċi iktar ċelluli bojod tad- demm li jgħinu lil ġismek biex jiġġieled l- infezzjoni.
If the number of white blood cells is too low (neutropenia), the risk of infection increases.
Jekk in- numru ta ’ ċelluli bojod tad- demm ikun baxx wisq (newtropenja), ir- riskju ta ’ infezzjoni jiżdied.
Anticancer chemotherapy
Kimoterapija kontra l- kanċer
Filgrastim HEXAL is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (with fever) which can be caused by the use of cytotoxic anticancer chemotherapy in children and adults.
Filgrastim HEXAL jintuża biex inaqqas it- tul ta ’ żmien ta ’ newtropenja u l- okkorrenza ta ’ newtropenja febbrili (b’ deni) li tista ’ tkun ikkawżata mill- użu ta ’ kimoterapija ċitotossika kontra l - kanċer fit- tfal u fl- adulti.
It is not used in patients with chronic myeloid leukaemia (CML) and myelodysplastic syndromes (MDS).
Ma jintużax f’ pazjenti b’ lewkimja majelojde kronika (CML) u sindromi majelodisplastiċi (MDS).
Bone marrow transplantation
Trapjant tal- mudullun
Filgrastim HEXAL is used to reduce the duration of neutropenia after high-dose chemotherapy and total body irradiation (radiotherapy) followed by bone marrow transplantation, in children and adults at increased risk of prolonged severe neutropenia.
Filgrastim HEXAL jintuża biex inaqqas iż- żmien kemm iddum in- newtropenja wara kimoterapija b’ doża għolja u irradjazzjoni totali tal- ġisem (radjuterapija) segwita minn trapjant tal- mudullun, fit- tfal u fl- adulti li huma f’ riskju miżjud ta ’ newtropenja severa għal żmien twil.
Peripheral blood stem cell mobilisation
Mobilizzazzjoni taċ- ċelluli staminali tad- demm periferali
Filgrastim HEXAL is used to stimulate the bone marrow to release (mobilisation) peripheral blood progenitor cells (PBPC, a type of stem cells) into the blood, so that they eventually grow and develop into all types of blood cells: white blood cells, red blood cells and platelets.
Filgrastim HEXAL jintuża biex jistimula l- mudullun biex jerħi (mobilizzazzjoni) ċelluli proġenituri tad- demm periferali (PBPC, tip ta ’ ċelluli staminali) ġod- demm, biex b’ hekk eventwalment jikbru u jiżviluppaw fit- tipi kollha ta ’ ċelluli tad- demm: ċelluli bojod tad- demm, ċelluli ħomor tad- demm u plejtlits.
If you are a patient with cancer these PBPCs will be removed from your blood and returned after your chemotherapy and/ or radiotherapy.
Jekk inti pazjent bil- kanċer, dawn il- PBPCs ser jitneħħew mid- demm tiegħek u jippoġġew lura wara l - kimoterapija u/ jew ir- radjuterapija tiegħek.
If you donate stem cells for another person, the PBPCs will be removed from your blood and given to the recipient after he/ she has received their chemotherapy and/ or radiotherapy.
Minħabba li l- kimoterapija u/ jew ir- radjuterapija jistgħu jnaqqsu l- attività tal- mudullun tiegħek, dan ser jgħin biex iħaffef l- irkuprar tiegħu.
52 Severe chronic neutropenia
52 Jekk tagħmel donazzjoni ta ’ ċelluli staminali għal persuna oħra, il- PBPCs ser jitneħħew mid- demm tiegħek u jingħataw lir- reċipjent wara li hu/ hi jkunu rċivew il- kimoterapija u/ jew ir- radjuterapija tagħhom.
Filgrastim HEXAL is used in children and adults to increase the number of white blood cells and reduce the occurrence and duration of infections related to specific forms of severe chronic neutropenia: congenital (inborn), cyclic (recurring), or idiopathic (without known cause).
Filgrastim HEXAL jintuża fit- tfal u fl- adulti biex iżid in- numru ta ’ ċelluli bojod tad- demm u jnaqqas l- okkorrenza u t- tul ta ’ żmien ta ’ infezzjonijiet marbuta ma ’ forom speċifiċi ta ’ newtropenja kronika severa: konġenitali (titwieled biha), ċiklika (isseħħ mill- ġdid), jew idjopatika (mingħajr kawża magħrufa).
HIV infection neutropenia
Newtropenja b’ infezzjoni bl- HIV
Filgrastim HEXAL is used to treat persistent neutropenia in patients with advanced HIV infection, in order to reduce the risk of bacterial infections, when other treatments are not appropriate.
Filgrastim HEXAL jintuża għall- kura ta ’ newtropenja persistenti f’ pazjenti b’ infezzjoni avvanzata tal - HIV, sabiex ser inaqqas ir- riskju ta ’ infezzjonijiet batterjali, meta kuri oħrajn ma jkunux adattati.
BEFORE YOU USE FILGRASTIM HEXAL
QABEL MA TUŻA FILGRASTIM HEXAL
Do not use Filgrastim HEXAL
Tużax Filgrastim HEXAL
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Filgrastim
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal filgrastim jew sustanzi oħra ta ’
HEXAL (listed in section 6. ‘ What Filgrastim HEXAL contains’).
Filgrastim HEXAL (elenkati f’ sezzjoni 6 ‘ X’ fih Filgrastim HEXAL ’)
Take special care with Filgrastim HEXAL Please tell your doctor:
Oqgħod attent ħafna b’ Filgrastim HEXAL Jekk jogħġbok għid lit- tabib tiegħek:
- if you have osteoporosis.
- jekk għandek l- osteoporożi.
- if you have sickle cell anaemia (disorder of the red blood cells leading to a sickle-shaped form
- jekk għandek anemija taċ- ċelluli sickle (disturb taċ- ċelluli ħomor tad- demm li jwassal li ċ- ċelluli
of the red blood cells).
ħomor tad- demm jieħdu l- forma ta ’ minġel).
- if you have specific blood disorders, such as myelodysplastic syndromes (MDS) or chronic
- jekk għandek disturbi speċifiċi tad- demm bħal sindromi majelodisplastiċi (MDS) jew lewkimja
myeloid leukaemia (CML).
majelojde kronika (CML).
- if you act as a donor for another person and are treated with anticoagulants (blood thinning
- jekk inti donatur ta ’ ċelluli staminali għal persuna oħra u qed tiġi kkurat b’ antikoagulanti
medicines) or you have bleeding problems.
(mediċini li jraqqu d- demm) jew jekk għandek problemi ta ’ ħruġ ta ’ demm.
Pregnancy and breast-feeding It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Tqala u treddigħ Hu importanti li tgħid lit- tabib tiegħek jekk inti tqila, taħseb li tista ’ tkun tqila jew qed tippjana li toħroġ tqila, għax it- tabib jista ’ jiddeċiedi li m’ għandekx tuża din il- mediċina.
Filgrastim could affect your ability to become or stay pregnant.
Filgrastim jista ’ jaffettwa l- ħila tiegħek li toħroġ tqila jew li t- tqala tiegħek tirnexxi.
Your doctor may decide that you should not use filgrastim if you are breast-feeding, as it is not known whether it passes into milk.
It- tabib tiegħek jista ’ jiddeċiedi li m’ għandekx tuża filgrastim jekk qed tredda ’, għax mhux magħruf jekk jgħaddix fil- ħalib.
Driving and using machines Filgrastim HEXAL has no influence on the ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Filgrastim HEXAL m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of Filgrastim HEXAL This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Filgrastim HEXAL Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO USE FILGRASTIM HEXAL
KIF GĦANDEK TUŻA FILGRASTIM HEXAL
The amount of Filgrastim HEXAL you need depends on your bodyweight and the condition you are treated for.
L- ammont ta ’ Filgrastim HEXAL li teħtieġ jiddependi fuq il- piż ta ’ ġismek u l- kundizzjoni li għaliha tkun qed tingħata kura.
53 Anticancer chemotherapy
53 Kimoterapija kontra l- kanċer
The usual dose is 0.5 million units (MU) per kg bodyweight each day.
Id- doża normali hi ta ’ 0. 5 miljun unità (MU) għal kull kg ta ’ piż tal- ġisem kuljum.
For example, if you weigh 60 kg, your daily dose will be 30 MU.
Per eżempju, jekk tiżen 60 kg, id- doża tiegħek ta ’ kuljum ser tkun ta ’ 30 MU.
The first dose should not be administered less than 24 hours following cytotoxic chemotherapy.
L- ewwel doża m’ għandhiex tingħata inqas minn 24 siegħa wara l- kimoterapija ċitotossika.
Your treatment can last up to 14 days.
Il- kura tiegħek tista ’ ddum sa 14- il jum.
In some disease types, however, longer treatment of up to about 1 month may be required.
F’ xi tipi ta ’ mard, madankollu, kura itwal ta ’ sa madwar xahar tista ’ tkun meħtieġ.
The usual starting dose is 1 MU per kg bodyweight each day.
Id- doża normali tal- bidu hi ta ’ 1 MU għal kull kg ta ’ piż tal- ġisem kuljum.
For example, if you weigh 60 kg, your daily dose will be 60 MU.
Per eżempju, jekk tiżen 60 kg, id- doża tiegħek ta ’ kuljum ser tkun ta ’ 60 MU.
You will normally receive your first dose at least 24 hours after your chemotherapy, but within 24 hours of receiving your bone marrow transfusion.
Normalment inti ser tirċievi l- ewwel doża tiegħek mill- inqas 24 siegħa wara l- kimoterapija tiegħek, iżda fi żmien 24 siegħa wara li tirċievi t - trasfużjoni tal- mudullun.
Your doctor will then test your blood to tell how well your treatment is working and how long it should last.
It- tabib tiegħek imbagħad ser jittestjalek id- demm biex jara kemm qed taħdem tajjeb il- kura u kemm għandha ddum.
- If you are donating stem cells for yourself, the usual dose is 1 MU per kg bodyweight each day.
- Jekk qed tagħti donazzjoni ta ’ ċelluli staminali għalik stess, id- doża normali hi ta ’
Filgrastim HEXAL will be given for 5 - 7 consecutive days.
Filgrastim HEXAL ser jingħata għal perjodu ta ’ 5 - 7 t’ ijiem konsekuttivi.
Treatment with Filgrastim HEXAL should be maintained until the last stem cell collection.
Il- kura b’ Filgrastim HEXAL għandha titkompla sal- aħħar ġbir ta ’ ċelluli staminali.
- If you are donating stem cells for yourself after chemotherapy, the usual dose is
- Jekk qed tagħti donazzjoni ta ’ ċelluli staminali għalik stess wara l- kimoterapija, id- doża normali
0.5 MU per kg bodyweight each day.
hi ta ’ 0. 5 MU għal kull kg ta ’ piż tal- ġisem kuljum.
Filgrastim HEXAL will be given until the expected lowest level of white blood cells is passed and has recovered to the normal range.
Filgrastim HEXAL ser jingħata sakemm l - inqas livell mistenni ta ’ ċelluli bojod tad- demm ikun għadda u jkun irkupra għall- medda normali.
- If you are acting as a stem cell donor for another person, the usual dose is
- Jekk inti donatur ta ’ ċelluli staminali għal persuna oħra, id- doża normali hi ta ’ 1 MU għal
1 MU per kg bodyweight each day.
kull kg ta ’ piż tal- ġisem kuljum.
Filgrastim HEXAL treatment will last for 4 - 5 consecutive days.
Il- kura b’ Filgrastim HEXAL iddum għal 4 - 5 t’ ijiem konsekuttivi.
Your doctor will perform regular blood tests to determine the best time to collect the stem cells.
It- tabib tiegħek ser jagħmillek testijiet regolari tad- demm biex jiddetermina l- aħjar ħin biex jieħu ċ - ċelluli staminali.
Severe chronic neutropenia
Newtropenja kronika severa
The usual starting dose is between 0.5 and 1.2 MU per kg bodyweight each day in a single or divided dose.
Id- doża tal- bidu normali hi bejn 0. 5 u 1. 2 MU kull kg ta ’ piż tal- ġisem kuljum f’ dożi waħidhom jew doża maqsuma.
Your doctor will then test your blood to see how well your treatment is working and to find the dose that is best for you.
It- tabib tiegħek imbagħad ser jittestjalek id- demm biex jara kemm qed taħdem tajjeb il- kura tiegħek u biex isib l- aħjar doża għalik.
Long-term treatment with Filgrastim HEXAL is required for neutropenia.
Il- kura fit- tul b’ Filgrastim HEXAL hi meħtieġa għan - newtropenja.
The usual starting dose is between 0.1 and 0.4 MU per kg bodyweight each day.
Id- doża tal- bidu normali hi bejn 0. 1 u 0. 4 MU għal kull kg ta ’ piż tal- ġisem kuljum.
Your doctor will test your blood at regular intervals to see how well the treatment is working.
It- tabib tiegħek ser jittestjalek id- demm f’ intervalli regolari biex jara kemm qed taħdem tajjeb il- kura.
Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day.
Ġaladarba n - numru ta ’ ċelluli bojod tad- demm ikun reġa ’ lura għan- normal, jista ’ jkun possibbli li tnaqqas il - frekwenza tad- doża għal inqas minn darba kuljum.
Your doctor will continue to test your blood regularly and will recommend the best dose for you.
It- tabib tiegħek ser ikompli jittestja d- demm tiegħek regolarment u ser jirrakkomanda l- aħjar doża għalik.
Long-term treatment with Filgrastim HEXAL may be required to maintain a normal number of white cells in your blood.
Il- kura fit- tul b’ Filgrastim HEXAL tista ’ tkun meħtieġa biex iżżomm numru normali ta ’ ċelluli bojod fid- demm tiegħek.
Children and adolescents
Tfal u adolexxenti
The dose recommendations are the same as those for adults receiving chemotherapy.
Ir- rakkomandazzjonijiet tad- doża huma l- istess bħal dawk tal- adulti li jkunu qed jirċievu l - kimoterapija.
How Filgrastim HEXAL is used Always use Filgrastim HEXAL exactly as your doctor has told you.
Kif tuża Filgrastim HEXAL Dejjem għandek tuża Filgrastim HEXAL skont il- parir eżatt tat- tabib.
You should check with your doctor, nurse or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib, l- infermiera jew mal- ispiżjar tiegħek jekk ikollok xi dubju.
This medicine is given by injection into the tissue just under the skin (subcutaneous injection), or through an intravenous infusion (“ a drip”).
54 permezz ta ’ injezzjoni fit- tessut li hi immedjatment taħt il- ġilda (injezzjoni subkutanea), jew permezz ta ’ infużjoni ġol- vini (“ dripp ”).
Your doctor may decide that it would be more convenient for you to inject Filgrastim HEXAL yourself.
It- tabib tiegħek jista ’ jiddeċiedi li jista ’ ikun aħjar għalik li tinjetta Filgrastim HEXAL inti stess.
Your doctor or nurse will show you how to inject yourself.
It - tabib jew l- infermiera tiegħek ser juruk kif tinjetta lilek innifsek.
Do not try to inject yourself if you have not been trained.
Tippruvax tinjetta lilek innifsek jekk ma tkunx ingħatajt taħriġ.
Instructions on how to inject yourself with Filgrastim HEXAL can be found at the end of this leaflet.
Struzzjonijiet dwar kif tinjetta Filgrastim HEXAL lilek innifsek, jinsabu fl- aħħar ta ’ dan il- fuljett.
54 If you use more Filgrastim HEXAL than you should
Jekk tuża Filgrastim HEXAL aktar milli suppost
If you have used more Filgrastim HEXAL than you should, contact your nurse, doctor or pharmacist immediately.
Jekk tkun użajt Filgrastim HEXAL aktar milli suppost, ikkuntattja lill- infermeira, lit- tabib jew lill - ispiżjar tiegħek immedjatament.
If you forget to use Filgrastim HEXAL
Jekk tinsa tuża Filgrastim HEXAL
If you have forgotten a dose of Filgrastim HEXAL, you should contact your doctor to discuss when you should inject the next dose.
Jekk tkun insejt tieħu doża ta ’ Filgrastim HEXAL, għandek tikkuntattja lit- tabib tiegħek biex tiddiskuti meta għandek tinjetta d- doża li jmiss.
If you stop using Filgrastim HEXAL
Jekk tieqaf tuża Filgrastim HEXAL
Your doctor will tell you when you can stop using Filgrastim HEXAL.
It- tabib tiegħek ser jgħidlek meta tkun tista ’ tieqaf tuża Filgrastim HEXAL.