FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of hospitalisations and Intra Venous 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).
Maltese: L-inċidenza ta' teħid l-isptar u l-użu antinfettiv Intra Venuż assoċjat ma' dijanjozi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbel mal-plaċebo (1% kontra 14 %, p < 0.001; u 2 % kontra 10 %, p < 0.001).
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFTs for ALT or AST1
Maltese: Żidiet f'lactate dehydrogenase u alkaline phosphatase Żidiet temporanji fl- LFTs għal ALT jew AST
English: Pegfilgrastim should be permanently discontinued in patients with clinically significant hypersensitivity.
Maltese: Pegfilgrastim għandu jitwaqqaf b'mod permaneneti f'pazjenti b'sensittività eċċessiva klinikament sinjifikanti.
English: Grasustek is a biosimilar medicinal product.
Maltese: Grasustek huwa prodott mediċinali bijosimili.
English: Excipient(s) with known effect Each pre-filled syringe contains 30 mg sorbitol (E 420) (see section 4.4).
Maltese: Kull siringa mimlija għal-lest fiha 30 mg sorbitol (E 420) (ara sezzjoni 4.4).
English: Grasustek is for use in adults aged 18 and over.
Maltese: Grasustek hu għall-użu minn adulti li għandhom 18-il sena u aktar.
English: OTHER Juta Pharma GmbH
Maltese: OĦRAJN Juta Pharma GmbH
English: Pulmonary adverse events
Maltese: Każijiet pulmonari avversi
English: Grasustek 6 mg pegfilgrastim SC
Maltese: U MNEJN GĦANDU JINGĦATA Grasustek 6 mg pegfilgrastim
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal fil-każ ta' fatturi ta' żvilupp ematopojetiku, G-CSF in vitro wera proprjetajiet stimulanti f'ċelloli endoteljali umani.
English: Ul Kniaźnina 4a lok 7
Maltese: Sp. Z o.o. Ul Kniaźnina 4a lok 7 01-607 Warsaw, Poland.
English: Sickle cell anaemia
Maltese: Anemija tas-sickle cell
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Maltese: Dan jista' jkun sinjal ta' Sindrome ta' Distress Respiratorju Akut (ARDS, Acute Respiratory Distress Syndrome)
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali Tqalligħ
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata tinsab fuq is-sit elettroniku talAġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: 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 %).
Maltese: Matul l-istudju kollu, ir-rata ta' newtropenija bid-deni kienet ta' 13 % f'pazjenti trattati b'pegfilgrastim meta mqabbla ma' 20 % f'pazjenti trattati b'filgrastim (differenza 7 %, 95 % CI ta'19 %, 5 %).
English: • If you have sickle cell anaemia.
Maltese: • għandek anemija tas-sickle cell.
English: Immune system Disorders
Maltese: Disturbi tassistema immuni
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal pegfilgrastim, filgrastim, proteini derivati minn E.coli, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli attwalment hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: 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.
Maltese: Fin-nuqqas ta' sostenn tal-fattur tal-iżvilupp, dan ilprogramm ta' kura ġie rapportat li rriżulta f'newtropenija ta' grad 4 b'tul ta' żmien medju ta' 5 sa 7 ijiem, u b'inċidenza ta' 30-40 % ta' newtropenija bid-deni.
English: Uncommon 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.
Maltese: Żidiet mhux komuni fil-livelli ta' testijiet tal-funzjoni tal-fwied (LFT, liver function tests) għal ALT (alanine aminotransferase) jew AST (aspartate aminotransferase) ġew osservati f'pazjenti wara li rċevew pegfilgrastim wara kimoterapija ċitotossika.
English: 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 Acute Respiratory Distress Syndrome (ARDS).
Maltese: Il-bidu ta' sinjali pulmonari bħal sogħla, deni, u dispnea flimkien ma' sinjali radjoloġiċi ta' infiltrati pulmonari, u funzjoni pulmonari li tmur għall-agħar flimkien ma' għadd ogħla ta' newtrofili jistgħu jkunu sinjali preliminari ta' Sindrome ta' Distress Respiratorju Akut (ARDS, Acute Respiratory Distress Syndrome).
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Maltese: B'mod konsistenti mal-effetti kliniċi u l-potenzjal għal lewkoċitosi, l-għadd tal-WBC għandu jsir f'intervalli regolari waqt it-terapija.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Maltese: Għadd taċ-ċelloli bojod tad-demm (WBC, white blood count) ta' 100 x 109/L ġie osservat f'inqas minn 1 % tal-pazjenti li jirċievu pegfilgrastim.
English: • coughing up blood (haemoptysis)
Maltese: • sogħla bid-demm (emoptisi)
English: 13 24941 Flensburg Germany
Maltese: 24941 Flensburg, , Il-Ġermanja
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Ġew rapportati b'mod mhux komuni reazzjonijiet pulmonari avversi li jinkludu pnewmonja interstizzjali, edema pulmonari, infiltrati pulmonari u fibrożi pulmonari.
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Maltese: Sindrome ta' Tnixxija Kapillari, li tista' tkun ta' theddida għall-ħajja jekk it-trattament ikun ittardjat ġie rapportat bħala mhux komuni (≥ 1/1,000 sa < 1/100) f'pazjenti bil-kanċer li jkunu għadejjin fuq kimoterapija wara l-għoti ta' fatturi li jistimulaw kolonji ta' granuloċiti: ara sezzjoni 4.4 u s-sezzjoni "Deskrizzjoni ta' reazzjonijiet avversi magħżula" taħt.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg /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).
Maltese: Fi studju sekondarju (n = 310), li uża doża fissa aġġustata (100 μg/kg) it-tul ta' żmien medju ta' newtropenija ta' grad 4 għall-grupp ta' pegfilgrastim kien ta' 1.7 jum meta mqabbel ma' 1.8 jum filgrupp ta' filgrastim (differenza ta' 0.03 jum, 95 % CI-0.36, 0.30).
English: Keep this medicine out of the sight and reach of children.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni.
English: 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.
Maltese: G-CSF jista' jqanqal l-iżvilupp ta' ċelloli mijelojdi, li jinkludu ċelluli malinni, in vitro u effetti simili jistgħu jiġu osservati f'xi ċelloli mhux mijelojdi in vitro.
English: With the exception of the youngest age group (0 5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and
Maltese: Bl-eċċezzjoni tal-grupp tal-iżgħar età (0-5 snin), l-AUC medja f'individwi pedjatriċi dehret simili għal dawk ta' pazjenti adulti bi stadju II-IV ta' kanċer tas-sider ta' riskju għoli u li rċevew 100 μg/kg pegfilgrastim wara t-tlestija ta' doxorubicin/docetaxel (ara sezzjonijiet 4.8 u 5.1).
English: In one study (n = 157), which used a 6 mg 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).
Maltese: Fi studju wieħed (n=157), li uża doża fissa ta' 6 mg ta' pegfilgrastim iż-żmien totali medju ta' newtropenija ta' grad 4 għall-grupp ta' pegfilgrastim kien ta' 1.8 jum meta mqabbel ma' 1.6 jum fil-grupp ta' filgrastim (differenza ta' 0.23 jum, 95 % CI0.15, 0.63).
English: Splenic rupture
Maltese: Disturbi vaskulari
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Maltese: Frekwenza ogħla ta' reazzjonijiet avversi serji fi tfal iżgħar bejn l-etajiet ta' 0 - 5 snin (92%) ġiet osservata meta mqabbla ma' tfal akbar ta' bejn 6-11-il sena u 12-21 sena rispettivament (80% u 67%) u adulti.
English: Pharmacokinetic properties
Maltese: Proprjetajiet farmakokinetiċi
English: Cutaneous Vasculitis1,2
Maltese: Stadju 1 Tħejjija
English: Loss of response to pegfilgrastim
Maltese: Nuqqas ta' rispons għal pegfilgrastim
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Maltese: Pazjenti li jiżviluppaw sintomi ta' sindrome ta' tnixxija kapillari għandhom jiġu monitorati mill-qrib u jirċievu trattament sintomatiku standard, li jista' jinkludi l-ħtieġa ta' kura intensiva (ara sezzjoni 4.8).
English: 1 See section “Description of selected adverse reactions” below.
Maltese: 1 Ara s-sezzjoni "Deskrizzjoni ta' reazzjonijiet avversi magħżula" taħt.
English: 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 %).
Maltese: Ir-rata globali ta' newtropenija bid-deni kienet ta' 9 % f'pazjenti trattati b'pegfilgrastim u 18% f'pazjenti trattati b'filgrastim (differenza ta' 9 %, 95 % CI ta' -16.
English: • Keep this leaflet.
Maltese: • Xi parti tkun mxaqqa jew mkissra.
English: 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 (AML) (see section 5.1).
Maltese: Tagħrif kliniku ristrett jissuġerixxi effett komparabbli fuq iż-żmien ta' rkupru ta' newtropenija severa għal pegfilgrastrim f'pazjenti b'lewkimja mijelojdi akuta (AML, acute myeloid leukaemia) (ara sezzjoni 5.1).
English: Rare side effects (may affect up to 1 in 1,000)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'1,000)
English: Pharmacodynamic properties
Maltese: Proprjetajiet farmakodinamiċi
English: EU/1/19/1375/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1375/001
English: • redness at the site of injection.
Maltese: • uġigħ fis-sit t'injezzjoni.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtiklu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: 01-607 Warsaw, Poland Tel: + 48 22 460 92 00
Maltese: Tel: + 48 22 460
English: 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).
Maltese: F'żewġ studji ewlenien, każwali u double-blind f'pazjenti fi stadju II-IV ta' riskju għoli tal-kanċer tas-sider, li kienu qed jieħdu kimoterapija mijelosuppressiva li kienet tikkonsisti minn doxorubiċin u docetaxel, l-użu ta' pegfigrastim, bħala doża unika li tingħata darba f'kull ċiklu, naqqas it-tul ta' żmien ta' newtropenija u l-inċidenza ta' newtropenija bid-deni bħal ma ġie osservat fl-għoti ta' kuljum ta' filgrastim (medjan ta' 11-il għotja kuljum).
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Maltese: Stampa 1: Profil tal-konċentrazzjoni medjana ta' pegfilgrastim fis-serum u l-għadd assolut ta' newtrofili (ANC, absolute neutrophil count) f'pazjenti trattati b'kimoterapija wara injezzjoni waħda ta' 6 mg
English: • If you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Maltese: • jekk riċentement kellek infezzjoni serja fil-pulmun (pnewmonja), ilma fil-pulmun (edema pulmonari), infjammazzjoni tal-pulmun (mard interstizzjali tal-pulmun) jew x-ray mhux normali tas-sider (infiltrazzjoni tal-pulmun)
English: APPROPRIATE
Maltese: Importanti
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17 %, p < 0.001).
Maltese: L-inċidenza ta' newtropenija bid-deni kienet inqas f'pazjenti li ġew magħżula b'mod każwali li jieħdu pegfilgrastim meta mqabbla ma' plaċebo (1 % kontra 17 %, p<0.001).
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Maltese: Bħal filgrastim, newtrofili prodotti bħala rispons għal pegfilgrastim juru funzjoni normali jew aktar qawwija kif muri b'tests ta' funzjoni kimotattika u fagoċitika.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Glomerulonefrite ġiet rapportata f'pazjenti li kienu qed jirċievu filgrastim u pegfilgrastim.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Maltese: Fi provi kliniċi, pegfilgrastim ġie amministrat b'mod sikur 14-il jum qabel il-kimoterapija.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Maltese: Ir-rati għallġenerazzjoni ta' antikorpi kontra pegfilgrastim huma ġeneralment baxxi.
English: Pack size of one pre-filled syringe with automatic needle guard (0.6 ml) and supplied in a dispensing pack containing one syringe.
Maltese: Id-daqs tal-pakkett ta' siringa waħda mimlija għal-lest b'tarka awtomatika għal-labra (0.6 ml) u fornut f'pakkett li jingħata b'siringa waħda.
English: This medicinal product contains 30 mg sorbitol in each 6 mg dose which is equivalent to 50 mg/ml.
Maltese: Dan il-prodott mediċinali fih 30 mg sorbitol f'kull doża ta' 6 mg li hu ekwivalenti għal 50 mg/ml.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Maltese: Jekk l-għadd ta' lewkoċiti jaqbeż 50 x 109/L wara nadir mistenni, il-prodott mediċinali għandu jitwaqqaf minnufih.
English: Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Maltese: Taħlit eċċessiv jista' jakkumula l-pegfilgrastim, u jagħmlu bijoloġikament inattiv.
English: Pegfilgrastim should not be administered to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Maltese: Pegfilgrastim m'għandux jingħata lil pazjenti bi storja medika ta' sensittività eċċessiva għal pegfilgrastim jew filgrastim.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Reazzjonijiet pulmonari avversi, b'mod partikolari pnewmonja interstizzjali, ġew rapportati wara l-għoti ta' G-CSF.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Maltese: Tagħrif ristrett jindika li l-farmakokinetiċi ta' pegfilgrastim f'individwi anzjani (> 65 sena) hu simili bħal dak ta' adulti.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull siringa mimlija għal-lest fiha 6 mg pegfilgrastim* f'0.6 ml (10 mg/ml) soluzzjoni għall-injezzjoni.
English: Grasustek is a clear, colourless solution for injection in pre-filled syringe (6 mg/0.6 ml).
Maltese: Grasustek huwa soluzzjoni ċara, u mingħajr kulur għall-injezzjoni f'siringa mimlija għal-lest (6 mg/0.6 ml).
English: Splenomegaly, generally asymptomatic, is uncommon.
Maltese: Splenomegalija, ġeneralment asintomatika, mhix komuni.
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Maltese: Pegfilgrastim ma affettwax il-prestazzjoni riproduttiva jew il-fertilità f'firien irġiel u nisa f'dożi kumulattivi kull ġimgħa ta' madwar 6 sa 9 darbiet ogħla mid-doża rakkomandata għall-bniedem (abbażi tal-erja superfiċjali tal-ġisem) (ara sezzjoni 5.3).
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Maltese: Tnaqqis fiż-żmien tan-newtropenija u l-inċidenza ta' newtropenija bid-deni f'pazjenti adulti trattati b'kimoterapija ċitotossika għal tumuri malinni (bl-eċċezzjoni ta' lewkimja mijelojde kronika u sindromi mijelodisplastiċi).
English: Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
Maltese: Każijiet mhux komuni ta' vaskulite tal-ġilda ġiet rapportata f'pazjenti trattati b'pegfilgrastim.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodju (23 mg) f'kull doża ta' 6 mg, jiġifieri huwa essenzjalment ‘ħieles mis-sodju'.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Maltese: Żieda bħal din fiċ-ċelluli bojod tad-demm hi temporanja, ġeneralment tidher f'24 sa 48 siegħa wara l-għoti u hi konsistenti mal-effetti farmakodinamiċi ta' dan il-prodott mediċinali.
English: Grasustek may be exposed to room temperature (not above 30 °C) for a maximum single period of up to 72 hours.
Maltese: Grasustek jista' jiġi espost għat-temperatura ambjentali tal-kamra (mhux aktar minn 30°C) għal perjodu wieħed massimu ta' 72 siegħa.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fuq mudelli tal-annimali l-għoti fl-istess waqt ta' pegfilgrastin u 5-fluorouracil (5-FU) jew antimetaboliti oħrajn intwera li jħarrex il-mijelosuppressjoni.
English: 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.
Maltese: II, każwali, double-blind f'pazjenti li rċevew kimoterapija għal lewkimja mijelojdi akuta de novo qabblet pegfilgrastim (doża unika ta' 6 mg) ma' filgrastim, mogħti waqt kimoterapija t'induzzjoni.
English: Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Maltese: Interazzjoni speċifika jew studji fuq il-metaboliżmu ma twettqux; madanakollu provi kliniċi ma ndikawx interazzjoni għal pegfilgrastim ma' prodotti mediċinali oħrajn.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati.
English: Thrombocytopenia Leukocytosis1
Maltese: Tromboċitopenija Lewkoċitosi
English: Additionally, a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Minbarra hekk, inċidenza ogħla ta' newtropenija bid-deni kienet osservata fi tfal iżgħar bejn l-etajiet ta' 0-5 snin (75 %) meta mqabbla ma' tfal akbar b'etajiet ta' bejn 6-11-il sena u bejn it-12-21 sena (70 % u 33 %, rispettivament) u adulti (ara sezzjonijiet 4.8 u 5.2).
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Prodott f'ċelluli ta'Escherichia coli b'teknoloġija rikombinanti tad-DNA segwita b'konjugazzjoni b'polyethylene glycol (PEG). ** Il-konċentrazzjoni hi ta' 20 mg/ml jekk il-porzjon ta' PEG jiġi inkluż.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żidiet riversibbli, minn ħfief għal moderati f'lactate dehydrogenase mingħajr effetti kliniċi assoċjati, ma kinux komuni f'pazjenti li rċevew pegfilgrastim wara kimoterapija ċitotossika.
English: 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).
Maltese: Fi studju double-blind, bil-plaċebo bħala kontroll f'pazjenti bil-kanċer tas-sider l-effett ta' pegfilgrastim fuq l-inċidenza ta' newtropenija bid-deni ġie evalwat wara l-għoti ta' programm ta' kura kimoterapewtiku assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20 % (docetaxel 100 mg/m kull
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħal fil-każ tal-proteini terapewtiċi kollha, hemm potenzjal għal immunoġeniċità.
English: (≥ 1/1,000 to
Maltese: Mhux komuni (≥ 1/1,000 sa
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Maltese: Attenzjoni partikolari għandha tingħata sabiex ssir distinzjoni tad-dijanjożi ta' blast transformation ta' lewkimja mijelojdi kronika minn AML.
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Maltese: Każijiet ta' sindrome ta' tnixxija kapillari ġew rapportati fl-ambjent ta' wara t-tqegħid fis-suq bl-użu tal-fattur li jistimula l-kolonji granuloċiti.