FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Maltese: • infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall ġisem), ara sezzjoni 2.
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/l.
Maltese: L-għoti fit-tul jista' jkun meħtieġ biex iżomm l-ANC f'> 2.0 x 109/l.
English: Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Maltese: Indeboliment renali Studji dwar filgrastim f'pazjenti b'indeboliment sever tal-funzjoni renali jew epatika juru profil farmakokinetiku u farmakodinamiku li hu simili bħal dak li jkun osservat f'individwi normali.
English: Excipient with known effect Each ml of solution contains 50 mg sorbitol (E420).
Maltese: Kull ml ta' soluzzjoni fih 50 mg ta' sorbitol (E420).
English: Filgrastim HEXAL is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Maltese: Filgrastim HEXAL normalment jingħata bħala injezzjoni ta' kuljum fit-tessut li jkun immedjatment taħt il-ġilda (magħrufa bħala injezzjoni taħt il-ġilda).
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*.
Maltese: Kull ml ta' soluzzjoni fih 96 miljun unità (MU) (ekwivalenti għal 960 mikrogramma [μg]) ta'
English: Hepatomegaly Blood alkaline phosphatase increased
Maltese: alkaline phosphatase fid-demm
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Maltese: L-ebda differenzi globali fis-sigurtà u l-effikaċja ma kienu osservati f'individwi li kellhom iktar minn 65 sena meta mqabbla ma' adulti iżgħar (> 18-il sena) li kienu qed jirċievu kimoterapija ċitotossika, u l-esperjenza klinika ma identifikatx differenzi fir-rispons bejn pazjenti adulti anzjani u pazjenti adulti iżgħar.
English: For patients treated with filgrastim diluted to concentrations < 1.5 MU/ml (15 μg/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Maltese: MU/ml (15 μg/ml), l-albumina tas-serum uman (HSA) għandha tiġi miżjuda għal konċentrazzjoni finali ta' 2 mg/ml.
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Maltese: • nefħa u/jew fluwidi fil-pulmun (edema pulmonari)
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C.
Maltese: 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.
English: Dizziness Hypoaesthesia Paraesthesia
Maltese: Kimoterapija ċitotossika stabbilita
English: Filgrastim HEXAL containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Filgrastim HEXAL li fih r-metHuG-CSF (filgrastim) jikkawża żidiet notevoli fl-għadd tan-newtrofili tad-demm periferali fi żmien 24 siegħa, b'żidiet żgħar fil-monoċiti.
English: Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Maltese: Sussegwentement id-doża tista' tiġi aġġustata individwalment kull ġimgħa-ġimagħtejn biex iżżomm il-medja tal-għadd tan-newtrofili bejn 1.5 x 109/l u 10 x 109/l.
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Maltese: Kien hemm frekwenza baxxa (ta' madwar 3%) ta' sindromi majelodisplastiċi (MDS) jew lewkimja f'pazjenti b'SCN li fuqhom saru provi kliniċi, ikkurati b'filgrastim.
English: There have been reports of Graft versus Host Disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.8 and 5.1).
Maltese: G-CSF wara trapjant alloġeneiku tal-mudullun (ara sezzjoni 4.8 u 5.1).
English: Filgrastim HEXAL contains no preservative.
Maltese: Filgrastim HEXAL ma fih ebda preservattiv.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Maltese: Interazzjonijiet possibbli ma' fatturi tat-tkabbir ematopojetiċi oħra u cytokines, s'issa ma kinux investigati fi provi kliniċi.
English: Aortitis Capillary leak syndromea
Maltese: Sindrome majelodisplastiku jew Lewkemija majelojde kronika
English: How long will I have to take Filgrastim HEXAL?
Maltese: Għal kemm żmien se jkolli nieħu Filgrastim HEXAL?
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Maltese: G-CSF umana hi glikoproteina li tirregola l-produzzjoni u l-ħruġ ta' newtrofili funzjonali mill-mudullun.
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Maltese: L-użu ta' filgrastim f'pazjenti, tfal jew adulti, b'SCN (newtropenja konġenitali severa, ċiklika, u idjopatika) jikkaġuna żieda sostnuta fl-ANCs fid-demm periferali u tnaqqis fl-infezzjoni u avvenimenti relatati.
English: • if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: • jekk ikollok xi wieħed minn dawn li ġejjin jew kombinazzjoni ta' l-effetti sekondarji li ġejjin: nefħa, li tista' tkun assoċjata ma' mogħdija tal-ilma inqas frekwenti, diffikultà biex tieħu nifs, nefħa addominali u sensazzjoni ta' milja, u sensazzjoni ġenerali ta' għeja.
English: 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.
Maltese: 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.
English: Infections and malignancies causing myelosuppression
Maltese: Infezzjonijiet u malinni li jikkawżaw majelosoppressjoni
English: Established cytotoxic chemotherapy
Maltese: Tromboċitopenija Anemijae
English: • if you experience kidney injury (glomerulonephritis).
Maltese: jekk ikollok ħsara fil-kliewi (glomerulonefrite).
English: Pregnancy
Maltese: Ipoksija
English: Each graduation ring corresponds to a volume of 0.1 ml.
Maltese: Kull ċirku tal-gradwazzjoni jikkorrispondi għal volum ta' 0.1 ml.
English: - Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Maltese: - Il-kura ta' newtropenja persistenti (ANC ≤ 1.0 x 109/l) f'pazjenti b'infezzjoni avvanzata tal-HIV,
English: Discontinue filgrastim
Maltese: filgrastim*.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy, suggesting no age-related differences in the pharmacokinetics of filgrastim.
Maltese: Dejta minn studji kliniċi f'pazjenti pedjatriċi juru li s-sigurtà u l-effikaċja ta' filgrastim huma simili kemm fl-adulti kif ukoll fit-tfal li jirċievu kimoterapija ċitotossika, u tissuġġerixxi għalhekk li m'hemm l-ebda differenza marbuta mal-età fil-farmokokinetika ta' filgrastim.
English: For reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MU/kg/day (1 μg/kg/day), with titration up to a maximum of 0.4 MU/kg/day (4 μg/kg/day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/l).
Maltese: MU/kg/kuljum (4 μg/kg/kuljum) sakemm jintlaħaq għadd normali ta' newtrofili u jkun jista' jinżamm (ANC > 2.0 x 109/l).
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 72 hours (but not above 25°C).
Maltese: Is-siringa tista' titneħħa minn ġol-friġġ u titħalla f'temperatura ambjentali tal-kamra għal perijodu wieħed li ma jdumx aktar minn 72 siegħa (imma mhux aktar minn 25°C).
English: During intermittent dosing with 30 MU/day (300 μg/day) of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Maltese: Matul id-dożaġġ intermittenti bi 30 MU/kuljum (300 μg/kuljum) ta' filgrastim, jista' jkun hemm fluttwazzjonijiet kbar fl-ANC
English: Based on reported data for another filgrastim product similar to the reference filgrastim product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50 - 90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Maltese: Ibbażat fuq dejta rrappurtata għal prodott ieħor, filgrastim simili għall-prodott filgrastim ta' referenza, f'doża ta' 100 µg/kg/kuljum ġew osservati sejbiet komparabbli flimkien ma' żieda ta' malformazzjonijiet fetali, doża tossika għall-omm li tikkorrispondi għal esponiment sistemiku ta'
English: Congenital neutropenia
Maltese: Retrospettiva Internazzjonali
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 μg/kg/day).
Maltese: MU/kg/kuljum (5 μg/kg/kuljum).
English: • cough
Maltese: • nawseja
English: Anaemiae
Maltese: Anzjani
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Maltese: Analiżi statistika tar-relazzjoni bejn in-numru ta' ċelluli CD34+ li jkunu infużi mill-ġdid u r-rata ta' irkuprar tal-plejtlits wara kimoterapija b'doża għolja tindika relazzjoni kumplessa iżda kontinwa.
English: The recommended starting dose of filgrastim is 1.0 MU/kg/day (10 μg/kg/day).
Maltese: MU/kg/kuljum (10 μg/kg/kuljum).
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience.
Maltese: Reazzjonijiet tat-tip ta' sensittività eċċessiva li jinkludu anafilassi, raxx, urtikarja, anġjoedema, dispneja u pressjoni baxxa li sseħħ fil-kura inizjali jew matul kura sussegwenti, ġew irrappurtati fi studji kliniċi u fl-esperjenza ta' wara t-tqegħid fis-suq.
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Maltese: Id-dejta kurrenti tindika li interazzjonijiet immunoloġiċi bejn trapjant alloġeneiku tal-PBPC u r-reċipjent jistgħu jiġu assoċjati ma' riskju miżjud ta' GvHD akut u kroniku meta mqabbel ma'
English: In clinical studies, dosing with 30 MU/day (300 μg/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/l, with the median dose frequency being 3 days per week.
Maltese: Fi studji kliniċi, dożaġġ bi 30 MU/kuljum (300 μg/kuljum) fuq perjodu ta' 1 - 7 ijiem kull ġimgħa kien meħtieġ biex iżomm l-ANC > 2.0 x 109/l, bil-medjan tal-frekwenza tad-doża li tkun ta' 3 t'ijiem kull ġimgħa.
English: Filgrastim HEXAL 30 MU/0.5 ml injection or infusion Filgrastim
Maltese: Filgrastim HEXAL 30 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Maltese: Fi provi kliniċi f'pazjenti bil-kanċer l-uġigħ muskoskeletriku kien ħafif jew moderat f'10%, u sever fi 3% tal-pazjenti.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Maltese: Sindromu ta' tnixxija tal-kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament huwa ttardjat, ġie rrapportat wara amministrazzjoni tal-fattur li jistimula l-kolonji ta' granuloċiti u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edema u hemokonċentrazzjoni.
English: Chest paina Paina
Maltese: Struzzjonijiet dwar kif tinjetta lilek innifsek
English: Filgrastim HEXAL 48 MU/0.5 ml injection or infusion Filgrastim
Maltese: Filgrastim HEXAL 48 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, eight retrospective studies and one case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Maltese: 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.
English: Splenic rupturea Sickle cell anaemia with crisis
Maltese: Anemija taċ ċelluli sickle bi kriżijiet
English: Filgrastim HEXAL 30 MU/0.5 ml
Maltese: Filgrastim HEXAL 30
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Maltese: 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 fi żmien 1 - 7 ijiem.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Maltese: Donaturi li jirċievu G-CSFs għal mobilizzazzjoni tal-PBPC għandhom jiġu mmonitorjati sakemm l-indiċi ematoloġiċi jerġgħu lura għan-normal.
English: 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.
Maltese: 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.
English: Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Maltese: Għandha tintuża attenzjoni speċjali meta wieħed jikkura pazjenti b'doża għolja ta' kimoterapija minħabba li ma ntweriex riżultat imtejjeb tat-tumur, u dożi intensifikati ta' mediċini kimoterapewtiċi jistgħu jwasslu għal żieda fit-tossiċitajiet li jinkludu effetti kardijaċi, pulmonari, newroloġiċi, u dermatoloġiċi (jekk jogħġbok irreferi għall-informazzjoni dwar l-għoti tal-mediċini tal-kimoterapija speċifika li tintuża).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i Sandoz GmbH
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Maltese: Għalkemm din l-interazzjoni ma kinitx investigata formalment, m'hemm l-ebda evidenza li interazzjoni bħal din hi ta' ħsara.
English: Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' filgrastim f'pazjenti bis-sindrome majelodisplastiku, jew b'lewkemija majelojde kronika, ma kinux stabbiliti.
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Maltese: Psewdogotta (Pirofosfat kondrokali-kinosi) ġiet irrappurtata f'pazjenti b'kanċer li kienu kkurati b'filgrastim.
English: Neutropenia may be due to bone marrow-infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Maltese: In-newtropenja tista' tkun minħabba infezzjonijiet opportunistiċi li jinfiltraw il-mudullun bħall-kumpless Mycobacterium avium jew malinni bħal limfoma.
English: Each pre-filled syringe contains 48 MU (equivalent to 480 μg) filgrastim in 0.5 ml.
Maltese: Kull siringa mimlija għal-lest fiha 48 MU (ekwivalenti għal 480 μg) ta' filgrastim f'0.5 ml.
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Sindrome ta' Problemi Respiratorji Akuti (ARDS - Acute Respiratory Distress Syndrome).
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuna)
English: White blood cell counts of 100 x 109/l or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 μg/kg/day).
Maltese: Għadd taċ-ċelluli tad-demm bojod ta' 100 x 109/l jew iżjed kien osservat f'inqas minn 5% tal-pazjenti bil-kanċer li kienu qed jirċievu filgrastim f'dożi ta' iktar minn 0.3 MU/kg/kuljum (3 μg/kg/kuljum).
English: The recommended starting dose is 1.2 MU/kg/day (12 μg/kg/day) as a single dose or in divided doses.
Maltese: Id-doża tal-bidu rakkomandata hi ta' 1.2 MU/kg/kuljum (12 μg/kg/kuljum) bħala doża waħda jew dożi maqsumin.
English: Filgrastim HEXAL 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Maltese: Filgrastim HEXAL 48 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest:
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/l.
Maltese: Jekk iktar minn lewkaferesi waħda tkun meħtieġa, għandha tingħata attenzjoni partikulari għal donaturi b'għadd tal-plejtlits ta' < 100 x 109/l qabel il-lewkaferesi; b'mod ġenerali l-aferesi m'għandhiex titwettaq jekk l-għadd tal-plejtlits ikun ta' < 75 x 109/l.
English: During long term use cutaneous vasculitis has been reported in 2% of SCN patients.
Maltese: Matul l-użu fit-tul, vaskulite tal-ġilda ġiet irrappurtata fi 2% ta' pazjenti b'SCN.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Maltese: Każijiet ġeneralment mingħajr sintomi ta' splenomegalija u każijiet ta' qsim tal-milsa ġew irrappurtati f'pazjenti u donaturi normali wara l-għoti ta' filgrastim.
English: 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
Maltese: 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
English: Glomerulonephritis has been reported in patients receiving filgrastim or pegfilgrastim.
Maltese: Glomerulonefrite kienet irrappurtata f'pazjenti li kienu qed jirċievu filgrastim jew pegfilgrastim.
English: Bronchitis Upper respiratory tract infection Urinary tract infection
Maltese: Bronkite Infezzjoni flapparat respiratorju ta' fuq
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Maltese: Reazzjonijiet avversi pulmonari, b'mod partikulari mard interstizjali tal-pulmun, kienu rrappurtati wara l-għoti ta' G-CSF.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Maltese: Xi mediċini ċitotossiċi juru tossiċitajiet partikulari għal pool ta' proġenituri ematopojetiċi u jistgħu jaffettwaw b'mod avvers il-mobilizzazzjoni tal-proġenituri.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Maltese: Pazjenti b'HFI ma jistgħux ikissru l-fructose, li jista' jikkawża effetti sekondarji serji.
English: 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.
Maltese: 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 vverifikati.
English: Splenomegaly and Splenic rupture
Maltese: Emoptisie Dispneja
English: Cutaneous vasculitis
Maltese: Użu fit-tfal
English: • to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;
Maltese: • biex iżidu n-numru ta' ċelluli tad-demm bojod jekk inti tbati minn newtropenija kronika severa biex jgħinu fil-prevenzjoni tal-infezzjonijiet;
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim huma simili fl-adulti u t-tfal li jkunu qed jirċievu l-kimoterapija ċitotossika.
English: Filgrastim HEXAL is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines.
Maltese: granuloċiti) u jappartjeni għal grupp ta' proteini msejħa cytokines.
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk filgrastim/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Maltese: Filgrastim jaġixxi primarjament fuq prekursuri newtrofili biex jeżerċita l-effett tiegħu biex iżid l-għadd tan-newtrofili.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers (e.g. C-reactive protein and white blood cell count) were raised.
Maltese: Issintomi li ħassew kienu jinkludu deni, uġigħ fl-addome, telqa, uġigħ fid-dahar u żieda fil-markaturi infjammatorji (eż. proteina C-reattiva u għadd ta' ċelloli bojod tad-demm).
English: 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.
Maltese: 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