qanastek/EMEA-V3 huggingface dataset:
In randomised clinical studies in patients with malignancy receiving Neulasta after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy.
Fi studji kliniċi randomised li saru fuq pazjenti b’ tumur malinn li kienu qed jingħataw Neulasta wara l - kimoterapija ċitotossika, ħafna mill- effetti mhux mixtieqa kienu kkawżati mit- tumur jew mill - kimoterapija ċitotossika.
The most frequently reported and very common study-drug related undesirable effect was bone pain Bone pain was generally of mild-to-moderate severity, transient and could be controlled in most patients with standard analgesics.
L- uġigħ fl- għadam kien ġeneralment ħafif għal moderat fil- qawwa tiegħu, temporanju u seta ’ jiġi kkontrollat fil- maġġoranza tal- pazjenti b’ mediċini komuni kontra l- uġigħ.
4 Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neulasta.
Reazzjonijiet ta ’ allerġija, inklużi anafilassi, raxx tal- ġilda, urtikarja, anġjoedema, qtugħ ta 'nifs, pressjoni baxxa, reazzjonijiet fil- post ta ’ l- injezzjoni, eritema u fwawar, li seħħew ma ’ l- ewwel trattament jew ma ’ trattament ta ’ wara, ġew rrappurtati b’ Neulasta.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
F 'ċertu każijiet, is- sintomi reġgħu seħħew hekk kif reġgħet ingħatat il- kura, b’ hekk tissuġġerixxi relazzjoni każwali.
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Jekk isseħħ reazzjoni allerġika serja, għandha tingħata t- terapija addattata, flimkien ma 'osservazzjoni mill- qrib tal- pazjent fuq bosta ġranet.
Pegfilgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Pegfilgrastim għandu jiġi mwaqqaf għal dejjem f' pazjenti li jkollhom reazzjoni allerġika serja.
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were common (1/ 100 to < 1/ 10); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were very common (1/ 10) in patients receiving Neulasta following cytotoxic chemotherapy.
Żjidiet ħfief għal moderati li jerġgħu għan- normal, u mingħajr effetti kliniċi assoċjati, f’ uric acid u f ’ alkaline phosphatase kienu komuni (≥ 1/ 100 u < 1/ 10); żjidiet ħfief għal moderati li jerġgħu għan - normal, u mingħajr effetti kliniċi assoċjati, f’ lactate dehydrogenase, kienu komuni ħafna (≥ 1/ 10) f’ pazjenti li ngħataw Neulasta wara l- kimoterapija ċitotossika.
Nausea was observed in healthy volunteers and patients receiving chemotherapy.
Dardir ġie osservat f’ voluntiera b’ saħħithom u f’ pazjenti li ngħataw il- kimoterapija.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.4).
Ġew rrappurtati wara l- għoti ta 'pegfilgrastim, każijiet ta' tkabbir tal- milza, dawn kienu komuni (≥ 1/ 100 u < 1/ 10) iżda ġeneralment mingħajr sintomi, u każijiet rari ħafna ta 'milza mifqugħha, fosthom ftit każijiet fatali (ara sezzjoni 4. 4).
Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and neck pain.
Effetti mhux mixtieqa oħra rrappurtati b’ mod komuni jinkludu uġigħ, uġigħ fis- sitfil- post ta ’ l- injezzjoni; uġigħ fis- sider (mhx kardijaku); uġigħ ta ’ ras; artralġja; mijalġja; uġigħ fid- dahar, riġlejn u dirgħajn, muskoloskeletali u fl- għonq.
Rare (1/ 10,000 to < 1/ 1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Effeti mhux mixtieqa rari (≥ 1/ 10, 000 u < 1/ 1, 000) tal- pulmun fosthom pulmonite interstizjali, nefħa minn akkumulazzjoni ta 'ilma fil- pulmun, infiltrati pulmonari, jew fibrożi pulmonari ġew rrappurtati.
Some of the reported cases have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4)
Ftit mill- każijiet rrappurtati rriżultaw f 'inkapaċità respiratorja jew sindromu tat- tbatija respiratorja fl - adulti (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4. 4)
Rare (1/ 10,000 to < 1/ 1,000) cases of thrombocytopenia and leukocytosis have been reported.
Każijiet rari (≥ 1/ 10, 000 u < 1/ 1, 000) ta 'tromboċitopenija u lewkoċitożi ġew rrappurtati.
Rare (1/ 10,000 to < 1/ 1,000) cases of Sweet’ s syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Ġew rrappurtati każijiet rari (≥ 1/ 10, 000 sa < 1/ 1, 000) tas- sindromu Sweet, għalkemm f' ċertu każijiet it- tumur malinn ematoloġiku li hemm minn taħt jista 'jkollu sehem f' dan.
Very rare (< 1/ 10,000) events of cutaneous vasculitis have been reported in patients treated with Neulasta.
Każijiet rari ħafna (< 1/ 10, 000) ta 'infjammazzjoni vaskulari fil- ġilda ġew osservati f' pazjenti li ngħataw Neulasta.
The mechanism of vasculitis in patients receiving Neulasta is unknown.
Il- mekkaniżmu ta 'l- infjammazzjoni vaskulari f' pazjenti li qed jirċievu Neulasta mhux magħruf.
Very rare (< 1/ 10,000) elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Każijiet rari ħafna (< 1/ 10, 000) ta 'żjidiet f’ ALT (alanine aminotransferase) jew f’ AST (aspartate aminotransferase), fit- testijiet tal- funzjoni tal- fwied (LFTs), ġew osservati f’ pazjenti wara li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
These elevations are transient and return to baseline.
Dawn iż- żjidiet huma temporanji u jerġgħu lura għal linja bażi.
Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Każijiet iżolati tal- marda taċ- ċellula b’ forma ta ’ minġel ġew rrappurtati f 'pazjenti bil- marda taċ - ċellula b’ forma ta ’ minġel (ara sezzjoni 4. 4).
There is no experience with overdose of Neulasta in humans.
M’ hemm l- ebda esperjenza b’ doża eċċessiva ta ’ Neulasta fil- bnedmin.
Cytokines, ATC Code:
Ċitokini, Kodiċi ATC:
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Il- fattur uman li jistimola l- kolonji ta ’ granuloċiti (G- CSF) huwa glikoproteina li tirregola il - produzzjoni u l- ħelsien ta ’ newtrofili mill- mudullun.
Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Pegfilgrastim huwa magħmul minn molekola ta ’ G- CSF umana rikombinanti (r- metHuG- CSF) marbuta b’ rabta kovalenti ma ’ molekola waħda ta ’ polyethyleneglycol (PEG) ta ’ 20 kd.
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Pegfilgrastim huwa forma ta ’ filgrastim li jdum aktar fil- ġisem minħabba li t- tneħħija mil- kliewi hija mnaqqsa.
Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/ or lymphocytes.
Intwera li pegfilgrastim u filgrastim għandhom mekkaniżmu ta ’ azzjoni identiku, u jikkawżaw żjieda sinifikanti fl- għadd ta ’ newtrofili fid- demm periferali fi żmien 24 siegħa, b ’ żjidiet minuri fil- monoċiti u/ jew fil- limfoċiti.
Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show
Bħal fil- każ ta ’ filgrastim, in- newtrofili li jiġu prodotti b’ rispons għal pegfilgrastim juru funzjonijiet normali jew miżjuda kif intwera f’ testijiet dwar il- funzjoni kimotattika u fagoċitika.
G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
G- CSF jista ’ jippromovi t- tkabbir in vitro ta ’ ċelluli majelojdi, inklużi ċelluli malinni, u effetti simili jistgħu jidhru wkoll fuq xi ċelluli mhux majelojdi in vitro.
In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
F’ żewġ studji randomised, double- blind, ta ’ importanza kbira, f’ pazjenti b' kankru tas- sider ta 'riskju għoli stat I- IV li kienu qed jingħataw kimoterapija majelosopressiva li tikkonsisti f ’ doxorubicin u docetaxel, l- użu ta ’ pegfilgrastim, bħala doża waħda kull ċiklu, naqqset id- dewmien tan- newtropenja u l- inċidenza ta ’ newtropenja bid- deni b’ mod simili għal dak osservat bl- għoti ta ’ kuljum ta ’ filgrastim (medja ta ’ 11- il għoti kuljum).
In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile neutropenia.
Fin- nuqqas ta ’ appoġġ ta ’ fattur ta ’ tkabbir, ġie rrappurtat li din l - iskema ta’ dożaġġ tirriżulta f’ newtropenja ta ’ grad 4 li ddum medja ta ’ 5 sa 7 ijiem, u inċidenza ta ’ 30 - 40% ta ’ newtropenja bid- deni.
In one study (n=157), which used a 6mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
Fi studju wieħed (n=157), fejn intużat doża fissa ta ’ 6 mg ta ’ pegfilgrastim id- dewmien medju tan- newtropenja grad 4 għall- grupp b’ pegfilgrastim kien ta ’ 1. 8 jiem meta mqabbel ma '1. 6 jiem tal- grupp b’ filgrastim (differenza ta ’ 0. 23 jiem, 95% CI - 0. 15, 0. 63).
Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 7%, 95% CI of -19%, 5%).
Matul l- istudju kollu, ir- rata ta ’ newtropenja bid- deni kienet ta ’ 13% tal- pazjenti kkurati b’ pegfilgrastim mqabbla ma ’ 20% tal- pazjenti kkurati b’ filgrastim (differenza ta ’ 7%, 95% CI ta ’ - 19%, 5%).
In a second study (n=310), which used a weight-adjusted dose (100 micrograms/ kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
Fi studju ieħor (n=310), fejn intużat doża maħduma skond il- piż (100 mikrogrammi/ kg), id- dewmien medju tan- newtropenja grad 4 għall- grupp b’ pegfilgrastim kienet ta ’ 1. 7 jiem, mqabbel ma ’ 1. 8 jiem tal- grupp b’ filgrastim (differenza ta ’ 0. 03 jiem, 95% CI - 0. 36, 0. 30).
The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%).
Ir- rata totali ta ’ newtropenja bid- deni kienet ta ’ 9% tal- pazjenti kkurati b’ pegfilgrastim u 18% tal- pazjenti kkurati b’ filgrastim (differenza ta ’ 9%, 95% CI ta ’ - 16. 8%, - 1. 1%).
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/ m2 every 3 weeks for 4 cycles).
Fi studju double- blind, kontrollat bil- plaċebo, fuq pazjenti bil- kankru tas- sider ġie evalwat l- effett ta 'pegfilgrastim fuq l- inċidenza tan- newtropenja bid- deni wara l- għoti ta' ċiklu ta 'kimoterapija assoċjat ma' newtropenja bid- deni b 'rata ta' 10- 20% (docetaxel 100mg/ m2 kull 3 ġimgħat għal 4 ċikli).
Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle.
Disa 'mija u tmienja u għoxrin pazjent ġew mqassma b' mod randomised biex jirċievu jew doża waħda ta' pegfilgrastim jew plaċebo bejn wieħed u ieħor 24 siegħa (Tieni ġurnata) wara l- kimoterapija f' kull ċiklu.
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001).
L- inċidenza tan- newtropenja bid- deni kienet aktar baxxa f' pazjenti li rċevew pegfilgrastim meta mqabbla ma 'dawk li reċevew il- plaċebo (1% versus 17%, p < 0. 001).
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001)
L- inċidenza ta 'dħul l- isptar u l - użu ta' anti- infettivi IV assoċjati ma 'dijanjożi klinika ta' newtropenja bid- deni kient aktar baxxa fil - grupp ta 'pegfilgrastim meta mqabbla mal- grupp tal- plaċebo (1% versus 14%, p < 0. 001; u 2% versus 10%, p < 0. 001).
A small (n=83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Fi studju żgħir (n=83), Fażi II, randomised, double- blind f 'pazjenti li reġgħet qabdithom lewkimja majelojde akuta u li qed jirċievu il- kimoterapija għaliha, ġie mqabbel pegfilgrastim (doża waħda ta' 6 mg) ma 'filgrastim waqt il- kimoterapija tal- bidu.
Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups.
Il- ħin medju biex tirkupra minn newtropenja severa ġie stmat għal 22 ġurnata fiż- żewġ ġruppi.
Long term outcome was not studied (see section 4.4).
L- effett fit- tul ma ġiex studjat (ara sezzjoni 4. 4).
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
L- eliminazzjoni ta ’
The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
6 pegfilgrastim m’ hiex lineari meta relatata mad- doża; u r- rata ta ’ tneħħija mis- serum ta ’ pegfilgrastim tonqos hekk kif tiżdied id- doża.
Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Jidher li pegfilgrastim jiġi mneħħi l- biċċa l- kbira permezz ta ’ tneħħija medjata minn newtrofili, din tiġi saturata f’ dożi ogħla.
Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure 1).
Fi qbil ma ’ mekkaniżmu ta ’ tneħħija li jirregola lilu nnifsu, il- konċentrazzjoni fis- serum ta ’ pegfilgrastim tonqos b’ ħeffa kbira malli jibdew jirpiljaw in- newtrofili (ara Figura 1).
6 Figure 1.
Figura 1 Profil tal- Medja tal- Konċentrazzjoni fis- serum ta ’ Pegfilgrastim u l- Għadd Assolut ta ’ Newtrofili (ANC) f ’ Pazjenti Kkurati b ’ kimoterapija wara Injezzjoni Waħda ta’ 6 mg
Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Minħabba l- mekkaniżmu ta ’ tneħħija medjata minn newtrofili, il- farmakokinetika ta ’ pegfilgrastim mhix mistennija li tiġi effettwata minn indeboliment fil- kliewi jew fil- fwied.
ANC
Tagħrif limitat jindika li l- farmakokinetika ta ’ pegfilgrastim fl- anzjani (> 65 sena) hija simili għal dik fl- adulti.
3
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta` tal- mediċina
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Tagħrif ta ’ qabel l- użu kliniku miġbur minn studji konvenzjonali fuq l- effett tossiku minn dożi riptetuti, wera l- effetti farmakoloġiċi mistennija fosthom żjidiet fl- għadd ta ’ lewkoċiti, iperplasija majelojde fil- mudullun, ematopojesi ekstramedullari u tkabbir tal- milza.
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/ foetal toxicity (embryo loss) at low subcutaneous doses.
Ma kien hemm l- ebda effett mhux mixtieq osservat fil- frieħ ta ’ firien tqal li ngħataw pegfilgrastim taħt il- ġilda, iżda fil- fniek pegfilgrastim ikkawża tossiċita` fl- embriju/ fetu (telfien ta’ l- embriju) f’ dożi baxxi taħt il- ġilda.
In rat studies, it was shown that pegfilgrastim may cross the placenta.
Fi studji fil- firien, intwera li pegfilgrastim għandu mnejn jgħaddi mis- sekonda.
The relevance of these findings for humans is not known.
Ir - rilevanza ta ’ dawn is- sejbiet għall- bnedmin mhix magħrufa.
Sodium acetate* Sorbitol (E420) Polysorbate 20 Water for injections
Sodium acetate * Sorbitol (E420) Polysorbate 20 Ilma għall- injezzjoni
*Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
7 * Sodium acetate huwa magħmul permezz ta ’ ddożar ta ’ glacial acetic acid ma ’ sodium hydroxide.
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Dan il- prodott mediċinali m ’ għandux jitħallat ma ’ prodotti mediċinali oħra, partikolarment ma ’ soluzzjonijiet ta ’ sodium chloride.
Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Neulasta jista ’ jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perijodu wieħed ta’ massimu ta ’ 72 siegħa.
Neulasta left at room temperature for more than 72 hours should be discarded.
Neulasta li tħalla f’ temperatura ambjentali għal aktar minn 72 siegħa għandu jintrema.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neulasta.
L- esposizzjoni bi żball għal temperatura ta ’ friża għal perjodu wieħed ta ’ inqas minn 24 siegħa ma jeffettwax ħażin l- istabilita` ta ’ Neulasta.
Keep the container in the outer carton, in order to protect from light.
Żomm il- kontenitur fil- pakkett ta ’ barra, sabiex tilqa 'mid- dawl.
0.6 ml of solution for injection in a pre-filled syringe (Type I glass), with a rubber stopper, and with a stainless steel needle.
0. 6 ml ta ’ soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (Ħġieġ Tip I), b ’ tapp tal- lastiku, u b’ labra ta ’ l- azzar li ma jissaddadx.
Pack size of one, in either blistered, with or without an automatic needle guard or non-blistered packaging.
Pakkett ta ’ waħda, f’ pakkett bil- folja, bi jew bla għatu ta ’ protezzjoni tal- labra awtomatiku, jew mingħajr folja.
Single use only.
Għall- użu ta ’ darba.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
L- għatu tal- labra tas- siringa mimlija għal- lest fih lastiku naturali niexef (imnissel mill- latex) (ara sezzjoni 4. 4).
Before administration, Neulasta solution should be inspected visually for particulate matter.
Qabel l- għoti, is- soluzzjoni Neulasta trid tiġi spezzjonata viżwalment għall- frak.
Only a solution that is clear and colourless should be injected.
Għandhom jsiru injezzjonijiet biss b’ soluzzjoni li tkun ċara u bla kulur.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Taħwid żejjed għandu mnejn jgħaqqad pegfilgrastim u jagħmlu bijoloġikament inattiv.
Allow the pre-filled syringe to reach room temperature before injecting.
Ħalli s- siringa mimlija għal- lest tilħaq it- temperatura ambjentali qabel ma tinjetta.
EU/ 1/ 02/ 227/ 001 1 pack blistered syringe EU/ 1/ 02/ 227/ 002 1 pack unblistered syringe EU/ 1/ 02/ 227/ 004 1 pack blistered syringe with needle guard
EU/ 1/ 02/ 227/ 001 pakkett ta ’ siringa waħda f’ folja EU/ 1/ 02/ 227/ 002 pakkett ta ’ siringa waħda mhux fil- folja EU/ 1/ 02/ 227/ 004 pakkett ta ’ siringa waħda b’ għatu ta ’ protezzjoni tal- labra f’ folja
22 August 2002 Date of last renewal:
22 ta ’ Awwissu 2002 Data ta ’ l- aħħar tiġdid:
Neulasta 6 mg solution for injection in a pre-filled pen.
Neulasta 6 mg soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Each pre-filled pen contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Kull pinna mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim * f ’ 0. 6 ml soluzzjoni għall- injezzjoni.
The concentration is 10 mg/ ml based on protein only**.
Il - konċentrazzjoni hija ta ’ 10 mg/ ml bbażata fuq il- proteina biss **.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ ml if the PEG moiety is included.
* Magħmul f ’ ċellui ta ’ Escherichia coli b ’ teknoloġija rikombinanti- DNA u wara b ’ konjugazzjoni ma ’ polyethylene glycol (PEG). ** Il- konċentrazzjoni hija ta ’ 20 mg/ ml jekk tiġi inkluża l- porzjoni PEG.
Solution for injection in a pre-filled pen (SureClick).
Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick).
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Tnaqqis fid- dewmien tan- newtropenja u ta’ l- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika għal tumur malinn (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi).
Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/ or haematology.
Il- kura b’ Neulasta għandha tinbeda u tiġi segwita minn tobba b’ esperjenza fl- onkoloġija u/ jew l - ematoloġija.
One 6 mg dose (a single pre-filled pen) of Neulasta is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Doża waħda ta ’ 6 mg (pinna waħda mimlija għal- lest) ta ’ Neulasta (SureClick) hija rrakkomandata għal kull ċiklu ta ’ kimoterapija, mogħtija bħala injezzjoni taħt il- ġilda bejn wieħed u ieħor 24 siegħa wara l- kimoterapija ċitotossika.
Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Indeboliment renali: l- ebda tibdil fid- doża m’ hu rrakkomandat f’ pazjenti b’ indeboliment renali, inklużi dawk b’ mard renali ta ’ l- aħħar stadju.
10 4.4 Special warnings and precautions for use
10 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Tagħrif kliniku limitat jissuġerixxi li l- effett fuq il- ħin biex tirkupra minn newtropenja severa f' pazjenti li reġgħet qabdithom lewkimja majelojde mill- ġdid, hija komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5. 1).
However, the long-term effects of Neulasta have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Madanakollu, l- effett fit- tul ta 'Neulasta għad ma ġiex stabbilit f' lewkimja majelojde akuta, għalhekk Neulasta għandu jintuża b 'kawzjoni f' dawn il- pazjenti.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Il- fattur li jistimola l- kolonji ta ’ granuloċiti jista 'jippromwovi it- tkabbir taċ- ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
The safety and efficacy of Neulasta have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Is- sigurtà u l- effikaċja ta 'Neulasta għad ma ġewx investigati f' pazjenti b 'sindromu majelodisplastiku, lewkimja mjeloġenika kronika, u f' pazjenti b 'Lewkimja Majelojde Akuta sekondarja; għalhekk, Neulasta m' għandux jintuża f 'pazjenti bħal dawn.
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count 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 flimkien ma ’ żjieda fl- għadd ta ’ newtrofili jistgħu jkunu sinjali tal- bidu tas- sindromi tat- tbatija respiratorja fl- adulti (ARDS).
In such circumstances Neulasta should be discontinued at the discretion of the physician and the appropriate treatment given.
F ’ ċirkostanzi bħal dawn Neulasta għandu jitwaqqaf skond il- parir tat- tabib u għandha tingħata l- kura addattata.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare (< 1/ 10,000 cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
Ġew rrappurtati wara l- għoti ta 'pegfilgrastim, każijiet ta' tkabbir tal- milza, dawn kienu komuni (≥ 1/ 100 u < 1/ 10) iżda ġeneralment mingħajr sintomi, u każijiet rari ħafna (< 1/ 10, 000) ta 'milza mifqugħha, fosthom ftit każijiet fatali.
Neulasta should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Neulasta m’ għandux jintuża biex tiżdied id- doża ta ’ kimoterapija ċitotossika għal aktar mil- limiti stabiliti tad- dożaġġ.
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease.
Kriżijiet tal- marda taċ- ċellula b’ forma ta ’ minġel ġew assoċjati ma 'l- użu ta' pegfilgrastim f 'pazjenti bil- marda taċ- ċellula b’ forma ta ’ minġel.
Therefore, physicians should exercise caution when administering Neulasta in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neulasta with splenic enlargement and vaso-occlusive crisis.
Għalhekk, it- tobba għandhom joqgħodu attenti meta jagħtu Neulasta lil pazjenti b ’ mard taċ- ċellula b’ forma ta ’ minġel, għandhom jikkontrollaw il- parametri kliniċi xierqa u l- qagħda tal- parametri tal- laboratorju u joqgħodu attenti għall- assoċjazzjoni possibbli bejn Neulasta u t- tkabbir tal- milza u kriżi vaso- okklusiva.
The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
11 Ma ġewx evalwati b’ mod xieraq is- sigurta` u l- effikaċja ta ’ Neulasta għall- mobiliżazzjoni taċ- ċelluli proġenitriċi tad- demm f ’ pazjenti jew f 'donaturi b’ saħħithom
11 The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
L- għatu tal- labra tal- pinna mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex), dan jista 'jikkawża reazzjonijiet allerġiċi.
Concomitant use of Neulasta with any chemotherapy agent has not been evaluated in patients.
Ma ġiex evalwat f’ pazjenti l- użu ta ’ Neulasta flimkien ma ’ kwalunkwe aġenti kimoterapewtiku.
In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Fi studji fuq annimali, l- għoti ta ’ Neulasta u 5- fluorouracil (5 - FU) jew anti- metaboliti oħra wriet żjieda fil - majelosoppressjoni.
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e. g., nitrosoureas.
Is- sigurta` u l- effikaċja ta ’ Neulasta ma ġietx evalwata f’ pazjenti li qed jirċievu kimoterapija assoċjata ma ’ majelosoppressjoni ittardjata eż, nitrosureja.
There are no adequate data from the use of pegfilgrastim in pregnant women.
M’ hemm l- ebda tagħrif xieraq dwar l- użu ta ’ pegfilgrastim f’ nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fl- annimali wrew tossiċita` riproduttiva (ara sezzjoni 5. 3).
There is no clinical experience with breast-feeding women, therefore Neulasta should not be administered to women who are breast-feeding.
M’ hemm l- ebda esperjenza klinika f’ nisa li qed ireddgħu, u għalhekk Neulasta m’ għandux jingħata lil nisa li qed irreddgħu.
4.8 Undesirable effects
12 4. 8 Effetti mhux mixtieqa
In randomised clinical studies in patients with malignancy receiving Neulasta after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy.
Fi studji kliniċi randomised li saru fuq pazjenti b’ tumur malinn li kienu qed jingħataw Neulasta wara l- kimoterapija ċitotossika, ħafna mill- effetti mhux mixtieqa kienu kkawżati mit- tumur jew mill - kimoterapija ċitotossika.
12 Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neulasta.
Reazzjonijiet ta ’ allerġija, inklużi anafilassi, raxx tal- ġilda, urtikarja, anġjoedema, qtugħ ta 'nifs, pressjoni baxxa, reazzjonijiet fl- post ta ’ l- injezzjoni, eritema u fwawar, li seħħew mal- bidu jew wara l - kura ġew irrapportati kemm b’ Neulasta kif ukoll bis- sustanza oriġinali li oriġina minnha Neulasta, filgrastim.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
F’ ċertu każijiet, is- sintomi reġgħu seħħew hekk kif reġgħet ingħatat il- kura, b’ hekk tissuġġerixxi relazzjoni każwali.
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Jekk isseħħ reazzjoni allerġika serja, għandha tingħata it- terapija addattata, flimkien ma 'osservazzjoni mill- qrib tal- pazjent fuq bosta ġranet.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.4).
Ġew rrappurtati wara l- għoti ta 'pegfilgrastim, każijiet ta' tkabbir tal- milza, dawn kienu komuni (≥ 1/ 100 u < 1/ 10)) iżda ġeneralment mingħajr sintomi, u każijiet rari ħafna ta 'milza mifqugħha, fosthom ftit każijiet fatali (ara sezzjoni 4. 4).
Rare (1/ 10,000 to < 1/ 1,000) cases of Sweet’ s syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Ġew rrappurtati każijiet rari (≥ 1/ 10, 000 sa < 1/ 1, 000) tas- sindromu Sweets, għalkemm f' ċertu każijiet it- tumur malinn ematoloġiku li hemm minn taħt jista 'jkollu sehem f' dan.
These elevations are transient and return to baseline.
Dawn iż- żjidiet kienu temporanji u jerġgħu lura għal linja bażi.
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/ m2 every 3 weeks for 4 cycles).
Fi studju double- blind, kontrollat bil- plaċebo, fuq pazjenti bil- kankru tas- sider ġie evalwat l- effett ta 'pegfilgrastim fuq l- inċidenza tan- newtropenja bid- deni wara l- għoti ta' ċiklu ta 'kimoterapija assoċjat ma' newtropenja bid- deni b 'rata ta' 10- 20% (doċetaxel 100mg/ m2 kull 3 ġimgħat għal 4 ċikli).
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Wara doża waħda ta ’ pegfilgrastim taħt il- ġilda, l- ogħla konċentrazzjoni fis- serum ta ’ pegfilgrastim tintlaħaq minn 16 sa 120 siegħa wara d- dożaġġ u l- konċentrazzjonijiet fis- serum ta ’ pegfilgrastim
The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
L- eliminazzjoni ta ’ pegfilgrastim m’ hiex lineari meta relatata mad- doża; u r- rata ta ’ tneħħija mis- serum ta ’ pegfilgrastim tonqos hekk kif tiżdied id- doża.
Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Figura 1 Profil tal- Medja tal- Konċentrazzjoni fis- serum ta ’ Pegfilgrastim u l- Għadd Assolut ta ’ Newtrofili (ANC) f ’ Pazjenti Kkurati b ’ kimoterapija wara Injezzjoni Waħda ta ’ 6 mg
Median Absolute Neutrophil Count (cells x 109/ l)
Minħabba l- mekkaniżmu ta ’ tneħħija medjata minn newtrofili, il- farmakokinetika ta ’ pegfilgrastim mhix mistennija li tiġi effettwata minn indeboliment fil- kliewi jew fil- fwied.
3
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
9
6. 1 Lista ta ’ sustanzi mhux attivi
12
Sodium acetate * Sorbitol (E420)
15
15 Polysorbate 20 Ilma għall- injezzjoni
*Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
* Sodium acetate huwa magħmul permezz ta ’ ddożar ta ’ glacial acetic acid ma ’ sodium hydroxide.
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Dan il- prodott mediċinali m ’ għandux jitħallat ma ’ prodotti mediċinali oħra, partikularment ma ’ soluzzjonijiet ta ’ sodium chloride.
15 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Neulasta jista ’ jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) darba waħda għal massimu ta ’ 72 siegħa.
Keep the container in the outer carton, in order to protect from light.
Żomm il- kontenitur fil- pakkett ta ’ barra, sabiex tilqa ’ mid- dawl.
The syringe inside the pen is made from Type I glass with a rubber stopper, and with a stainless steel needle; it contains 0.6 ml of solution for injection.
0. 6 ml ta ’ soluzzjoni għall- injezzjoni.
Pack size of one, for single use only.
Pakkett ta ’ waħda, għall- użu ta ’ darba.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
L- għatu tal- labra tal- pinna mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex).
The carton contains a package leaflet with the full instructions for use and handling.
Il- kartuna fiha fuljett ta 'tagħrif bl- istruzzjonijiet kollha għal użu u għal immaniġġar.
Before administration, Neulasta solution should be inspected visually for particulate matter.
Qabel l- għoti, is- soluzzjoni Neulasta trid tiġi spezzjonata bl- għajnejn għall- frak.
Only a solution that is clear and colourless should be injected.
Għandhom jisiru injezzjonijiet biss b’ soluzzjoni li tkun ċara u bla kulur.
Each pen may only be used once.
Kull pinna tista 'tiġi użata darba biss.
Allow the pre-filled pen to reach room temperature before injecting.
Ħalli l- pinna mimlija għal- lest tilħaq it- temperatura ambjentali qabel ma tinjetta.
18 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
18 A MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
One Amgen Center Drive Thousand Oaks CA 91320 USA
One Amgen Center Drive Thousand Oaks CA 91320 L- Istati Uniti
24.6 Juncos Puerto Rico 00777-4060 USA
24. 6 Juncos Puerto Rico 00777- 4060 L- istati Uniti
Amgen Europe BV Minervum 7061 NL-4817 ZK Breda The Netherlands
Amgen Europe BV Minervum 7061 NL- 4817 ZK Breda L- Olanda
Summary of Product Characteristics, 4.2).
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2).
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA SIRINGA F’ FOLJA
Neulasta 6 mg solution for injection Pegfilgrastim
Neulasta 6 mg soluzzjoni għall- injezzjoni Pegfilgrastim
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ ml) solution for injection.
Kull siringa mimlija għal- lest fiha 6mg ta ’ pegfilgrastim f ’ 0. 6ml (10mg/ ml) soluzzjoni għall - injezzjoni).
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall- injezzjoni.
Excipients known to have a recognised action: sorbitol (E420), sodium acetate.
Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E- 420, sodium acetate.
See leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
Solution for injection in a single use pre-filled syringe (0.6 ml).
Soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (0. 6ml).
Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 ml).
Soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest għall- użu ta ’ darba b’ għatu ta ’ protezzjoni tal - labra awtomatiku (0. 6ml).
Pack size of one.
Pakkett ta ’ waħda.
For subcutaneous use.
Użu għal taħt il- ġilda.
Avoid vigorous shaking.
Evita li tħawwad iż- żejjed.
EU/ 1/ 02/ 227/ 001 1 pack EU/ 1/ 02/ 227/ 004 1 Pack with needle guard
EU/ 1/ 02/ 227/ 001 pakkett wieħed EU/ 1/ 02/ 227/ 004 Pakkett wieħed b’ għatu ta ’ protezzjoni tal- labra
23 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA B’ SIRINGA ĠO FIHA
Neulasta 6 mg injection Pegfilgrastim
Neulasta 6 mg injezzjoni Pegfilgrastim
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ SIRINGA ĠO FOLJA
UNBLISTERED SYRINGE OUTER CARTON
PAKKETT TA ’ BARRA TA ’ SIRINGA MHUX ĠO FOLJA
Neulasta 6 mg solution for injection Pegfilgrastim
Neulasta 6 mg Soluzzjoni għall- injezzjoni Pegfilgrastim
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20, ilma għall- injezzjoni.
Solution for injection in a single use pre-filled syringe (0.6 ml).
Soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (0. 6 ml).
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ SIRINGA MHUX ĠO FOLJA
Neulasta 6 mg injection Pegfilgrastim SC
Neulasta 6 mg injezzjoni Pegfilgrastim SC
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA
Neulasta 6 mg solution for injection in a pre-filled pen Pegfilgrastim
Neulasta 6 mg soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest Pegfilgrastim
Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ ml) solution for injection.
Kull pinna mimlija għal- lest fiha 6 mg pegfilgrastim f’ 0. 6ml (10 mg/ ml) soluzzjoni għall- injezzjoni.
Solution for injection in a single use pre-filled pen (0.6 ml).
Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (0. 6 ml).
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ PINNA MIMLIJA GĦAL- LEST
Neulasta 6 mg injection Pegfilgrastim SC
Pegfilgrastim SC
Neulasta 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Neulasta 6 mg soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest pegfilgrastim
What Neulasta is and what it is used for 2.
X’ inhu Neulasta u għalxiex jintuża 2.
Before you use Neulasta 3.
Qabel ma tuża Neulasta 3.
How to use Neulasta 4.
Kif għandek tuża Neulasta Effetti sekondarji li jista ’ jkollu 4.
How to store Neulasta 6.
Kif taħżen Neulasta 6.
WHAT NEULASTA IS AND WHAT IT IS USED FOR
X’ INHU NEULASTA U GĦALXIEX JINTUŻA
Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Neulasta jintuża biex inaqqas id- dewmien ta ’ newtropenja (għadd baxx ta ’ ċelluli bojod fid- demm) u ta ’ newtropenja bid- deni (għadd baxx ta ’ ċelluli bojod fid- demm u deni) li jistgħu jkunu kkawżati minn kimoterapija ċitotossika (mediċini li jeqirdu ċ- ċelluli li jikbru malajr).
White blood cells are important as they help your body fight infection.
Iċ- ċelluli bojod tad- demm huma importanti għaliex jgħinu ‘ l ġismek jiġġieled l- infezzjonijiet.
These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Dawn iċ- ċelluli huma sensittivi ħafna għall- effetti ta ’ kimoterapija li tista ’ tikkawża tnaqqis fin- numru ta ’ dawn iċ- ċelluli f’ ġismek.
If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Jekk iċ- ċelluli bojod jinżlu għal livell baxx għandu mnejn ma jkunx baqa ’ biżżejjed fil- ġisem biex jiġġieldu ‘ l batterji u jista ’ jkollok riskju ogħla ta ’ infezzjoni.
Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
It- tabib tiegħek tak Neulasta biex jgħin il- mudullun (parti mill- għadma li tagħmel iċ- ċelluli tad- demm) jipproduċi aktar ċelluli bojod sabiex ġismek ikun jista ’ jilqa ’ għall- infezzjoni u jiġġildilha.
BEFORE YOU USE NEULASTA
QABEL MA TUŻA NEULASTA
Do not use Neulasta
Tużax Neulasta
• if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neulasta.
• jekk tbati minn sensittività eċċessiva (allerġija) għal pegfilgrastim, filgrastim, proteini ġejjin minn E. Coli, jew xi sustanza oħra ta ’ Neulasta.
Take special care with Neulasta
Oqgħod attent ħafna b’ Neulasta
Please tell your doctor:
Għarraf lit- tabib tiegħek:
• if you experience a cough, fever and difficulty breathing;
jekk inti taqbdek is- sogħla, jitlagħlek id- deni jew ikollok problemi biex tieħu n- nifs; •
• if you have sickle cell anaemia;
jekk inti għandek anemija taċ- ċellula b’ forma ta ’ minġel; •
• if you get left upper abdominal pain or pain at the tip of your shoulder;
jekk inti għandek uġigħ addominali fin- naħa ta ’ fuq jew fit- tarf ta ’ l- ispalla. •
33 Using other medicines
33 jekk inti allerġiku għall- latex.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mediċini li xtrajt mingħajr riċetta.
Neulasta has not been tested in pregnant women.
Neulasta ma ġiex ittestjat f’ nisa tqal.
• plan to become pregnant.
• qed taħseb biex issir tqila.
You must stop breast feeding if you use Neulasta.
Għandek tieqaf tredda ’ jekk qed tuża Neulasta.
The effect of Neulasta on the ability to drive or use machines is not known.
L- effett ta ’ Neulasta fuq il- kapaċita` li ssuq u li tħaddem magni mhuwiex magħruf.
Important information about some of the ingredients of Neulasta
Tagħarif importanti dwar xi uħud mis- sustanzi ta ’ NeulastaNeulasta fih 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 Neulasta.
Jekk it- tabib tiegħek qallek li inti għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntatja lit- tabib tiegħek qabel ma ’ tieħu Neulasta.
Neulasta is essentially sodium-free.
Neulasta huwa essenzjalment mingħajr sodium.
HOW TO USE NEULASTA
KIF GĦANDEK TUŻA NEULASTA
Neulasta is for use in adults aged 18 and over.
Neulasta huwa għall- użu f ’ adulti ta ’ 18- il sena ‘ l fuq.
Always take Neulasta exactly as your doctor has told you.
Dejjem għandek tieħu Neulasta skond il- parir eżatt tat- tabib.
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Id- doża li ssoltu tingħata hija ta ’ injezzjoni taħt il - ġilda b’ siringa mimlija għal- lest ta ’ 6 mg u li għandha tingħata bejn wieħed u ieħor 24 siegħa wara l - aħħar doża ta ’ kimoterapija fi tmiem kull ċiklu ta ’ kimoterapija.
Do not shake Neulasta vigorously as this may affect its activity
Tħawwadx Neulasta bil- qawwa għaliex dan jista ’ jeffettwa l- mod kif jaħdem.
Injecting Neulasta yourself
Jekk tinjetta lilek innifsek b’ Neulasta
Your doctor may decide that it would be more convenient for you to inject Neulasta yourself.
It- tabib jista ’ jiddeċiedi li jkun aħjar għalik jekk tinjetta lilek innifsek b ’ Neulasta.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l - infermiera juruk kif tagħmel dan.
For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.
Għal aktar istruzzjonijiet dwar kif tinjetta lilek innifsek b’ Neulasta, jekk jogħġbok aqra s- sezzjoni fi tmiem dan il- fuljett.
If you use more Neulasta than you should
Jekk tuża Neulasta aktar milli suppost
If you use more Neulasta than you should contact your doctor, nurse or pharmacist.
Jekk tuża Neulasta aktar milli suppost, għandek tgħarraf lit- tabib, l- infermiera jew l- ispiżjar tiegħek.
34 If you forget to inject Neulasta
34 Jekk tinsa tieħu Neulasta:
If you have forgotten a dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.
Jekk tinsa tieħu d- doża ta ’ Neulasta, kellem lit- tabib tiegħek biex jara meta jmissek tinjetta d- doża li jmiss.
Like all medicines, Neulasta can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Neulasta jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain.
Effett sekondarju ieħor komuni ħafna (li hemm ċans li jseħħ f ’ aktar minn pazjent 1 f ’ kull 10 pazjenti) huwa l- uġigħ fl- għadam.
Your doctor will tell you what you can take to ease the bone pain.
It- tabib tiegħek jgħidlek x’ tista ’ tieħu biex ittaffi l- uġigħ fl- għadam.
Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back.
Effetti sekondarji oħra komuni (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 10 pazjenti) jinkludu: uġigħ u ħmura fil- post ta’ l- injezzjoni, uġigħ ta ’ ras, u uġigħ ġenerali fil- ġogi, il- muskoli, is - sider, ir- riġlejn, l- għonq jew id- dahar.
An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.
Effett sekondarju ieħor li mhux komuni (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 100 pazjent) huwa d- dardir.
Allergic-type reactions to Neulasta, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
Reazzjonijiet ta ’ allerġija għal Neulasta, inklużi ħmura u fwawar, raxx tal- ġilda, partijiet tal- ġilda ibbuzzati li jqabbdu l- ħakk u anafilassi (indeboliment, tbaxxija tal- pressjoni tad- demm, tbatija biex tieħu n- nifs, nefħa fil- wiċċ), ġew irrappurtati f’ każijiet rari (hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1000 pazjent).
Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients) of spleen rupture have been reported after the use of Neulasta.
Żjieda fid- daqs tal- milza u każijiet rari ħafna (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 10, 000 pazjent) ta 'milza mifqugħha ġew irrappurtati wara l- użu ta' Neulasta.
Some cases of splenic rupture were fatal.
Ftit każijiet ta 'milza mifqugħha kienu fatali.