FrancophonIA/ELRC3.0 huggingface dataset:
English: For example, if you weigh 60 kg your daily dose will be 60 million international units (MIU).
Maltese: Per eżempju, jekk tiżen 60 kg, id-doża tiegħek ta' kuljum hi ta' 60 miljun international units (MIU).
English: Vascular disorders
Maltese: Tromboċitopenja
English: 1 pre-filled syringe containing 0.5 mL 5 pre-filled syringes containing 0.5 mL 5 pre-filled syringes with safety device containing 0.5 mL 10 pre-filled syringes containing 0.5 mL
Maltese: 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra b'0.5 mL 10 siringi mimlija għal-lest b'0.5 mL
English: Symptoms suggestive of severe allergic reactions have been reported very rarely.
Maltese: Sintomi li jissuġġerixxu reazzjonijiet allerġiċi qawwija ġew rapportati f'każijiet rari ħafna.
English: Anaemia, splenomegaly
Maltese: Reazzjoni allerġiku qawwija
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 10
Maltese: Jista' jkun li pazjenti li għaddew minn kura majelosoppressiva estensiva ma jkollhomx mobilizzazzjoni suffiċjenti ta' PBPC biex jaslu għall-għadd minimu rakkomandat (2.0 x 106 CD34+
English: Chronic GvHD
Maltese: GvHD kronika TRM
English: The volume of distribution in blood is approximately 150 mL/kg.
Maltese: Il-volum ta' distribuzzjoni fid-demm hu madwar 150 mL/kg.
English: Excipients
Maltese: Eċċipjenti:
English: Biograstim and severe chronic neutropenia
Maltese: Biograstim u newtropenja severa u kronika
English: There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Maltese: Ma kienx hemm differenzi rilevanti bejn Biograstim u l-prodott ta' referenza fir-rigward ta' dewmien ta' newtropenja qawwija u l-inċidenza ta' newtropenja bid-deni.
English: 9/L) following filgrastim administration and
Maltese: Waqqaf il-kura b'filgrastim
English: Biograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Biograstim, li fih r-metHuG-CSF (filgrastim), jikkawża żjieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żjidiet minuri fil-monoċiti.
English: Biograstim does not contain any preservative.
Maltese: Biograstim ma fih l-ebda preservattiv.
English: Talk to your doctor or nurse that you are treated with Biograstim if you are undergoing bone-imaging.
Maltese: Għat-trattament ta' newtropenja, ikun hemm bżonn ta' kura b'Biograstim fit-tul.
English: Common (may affect up to 1 in 10 people): - headache; - cough; sore throat; - constipation; loss of appetite; diarrhoea; mucositis, which is painful inflammation and ulceration of the mucous membranes lining the digestive tract; - hair loss; rash; - fatigue; generalised weakness.
Maltese: Komuni ħafna (jistgħu jaffettwaw iktar minn 1 minn kull 10 persuni): - żjidiet fil-livelli ta' xi enżimi tal-fwied u tad-demm; livelli għolja ta' uric acid fid-demm; - ħass ħażin; rimettar - uġigħ fis-sider
English: Each mL of solution for injection or infusion contains 60 million international units [MIU] (600 microgram) of filgrastim.
Maltese: Kull mL ta' soluzzjoni għall-injezzjoni jew infużjoni fiha 60 miljun international units [MIU] (600 mikrogramma) ta' filgrastim.
English: In SCN patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: 9/L) was observed in 41 % of donors and transient 9/L) following filgrastim and leukapheresis was observed in thrombocytopenia (platelets < 100 x 10
Maltese: Lewkoċitosi (WBC > 50 x 109/L) ġie osservat f'41% tad-donaturi waqt li tromboċitopenja reversibbli (plejtlits < 100 x 109/L) ġiet osservata f'35% tad-donaturi wara amministrazzjoni ta' filgrastim u lewkafereżi.
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' sindromu ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu kura simtomatika standard, li jistgħu jinkludu ħtieġa għal kura intensiva (ara sezzjoni 4.8).
English: The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Maltese: Id-doża li tintuża normali hija 0.5 miljun international units (MIU) għal kull kilogramm ta' piż talġisem, kuljum.
English: If required, Biograstim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Maltese: Jekk ikun hemm bżonn, Biograstim jista' jiġi dilwit f'soluzzjoni għal infużjoni ta' glucose 50 mg/mL (5%).
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 alloġeniku tal-mudullun f'pazjenti b'lewkimji akuti, issuġġerixxa żieda fir-riskju ta' GvHD, mortalità marbuta mal-kura (TRM) u l-mortalità meta ngħata
English: In patients with HIV
Maltese: F'pazjenti b'HIV
English: The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μg)/kg/day given by continuous 24 hour subcutaneous infusion.
Maltese: Fi studji kliniċi randomised, intużat doża ta' 23 MIU (230 μg)/m2/jum (4.0 sa 8.4 μg/kg/jum) li ġiet amministrata taħt il-ġilda.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Maltese: Pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest b'0.8 mL ta' soluzzjoni jew pakkett multiplu li fih 10 (2 pakketti ta' 5) siringi mimlijin għal-lest b'0.8 mL ta' soluzzjoni.
English: Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50 %, 35 %, 25 %, and 10 % of patients respectively, at recommended doses.
Maltese: Żjidiet ħfief għal moderati, li reġgħu lura għan-normal, u li kienu dipendenti fuq id-doża, f'lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid u gamma-glutamyltransferase (GGT),
English: < 50 x 10
Maltese: 30 xahar
English: The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Maltese: MIU (5 μg)/kg/jum.
English: Musculoskeletal pain Osteoporosis
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL (60 MIU/mL, 600 microgram/mL).
Maltese: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 mL (60
English: Haematuria/proteinuria occurred in a small number of patients.
Maltese: Ematurja/proteinurja seħħ f'numru żgħir ta' pazjenti.
English: ● Periodic Safety Update Reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: Uncommon (may affect up to 1 in 100 people): - blood in the urine; protein in the urine.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): - demm fl-awrina, protejn fl-awrina.
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Maltese: Madankollu, intwera' li l-amministrazzjoni ta' melphalan, carboplatin jew BCNU flimkien ma' filgrastim kien effettiv fil-mobilizzazzjoni taċ-ċelluli proġenitriċi.
English: Biograstim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Maltese: Biograstim jiġi f'pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest jew f'pakkett multiplu ta'10 (2 pakketti ta' 5).
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 mL solution.
Maltese: Pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest b'0.5 mL ta' soluzzjoni jew pakkett multiplu li fih 10 (2 pakketti ta' 5) siringi mimlijin għal-lest b'0.5 mL ta' soluzzjoni.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I : Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2)
English: Spleen disorder
Maltese: Disturbi vaskulari
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimola l-kolonji ta' granuloċiti jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
English: Elevated GGT
Maltese: Informazzjoni għall-utent
English: > 1.0 x 10
Maltese: > 1.0 x 109/L għal 3 ijiem konsekuttivi
English: Other medicines and Biograstim
Maltese: Mediċini oħra u Biograstim
English: Biograstim 48 MIU/0.8 mL solution for injection or infusion
Maltese: Biograstim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni jew infużjoni
English: The syringe has a scale on the syringe barrel.
Maltese: Fuq it-tubu tas-siringa hemm skala.
English: Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.
Maltese: Effetti mhux mixtieqa inqas frekwenti jinkludu disturbi fis-sistema urinarja, bl-effett predominanti jkun diżurja ħafif għal moderat.
English: Biograstim 30 MIU/0.5 mL solution for injection or infusion
Maltese: Biograstim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni
English: Hepatomegaly
Maltese: Il-Ġermanja
English: Thrombocytopenia
Maltese: Twissijiet speċjali
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Maltese: Pazjenti b'każ reċenti ta' infiltrati pulmonari jew pulmonite jista' jkollhom riskju għola.
English: Very rare (may affect up to 1 in 10,000 people): - painful, raised, plum-coloured sores on the limbs and sometimes the face and neck with fever
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): - disturbi vaskulari (li jistgħu jikkawżaw ugigħ, ħmura u nefħa fid-dirgħajn u riġlejn).
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Maltese: Evidenza preliminari, li ġej minn studju f'numru żgħir ta'pazjenti li ngħataw filgrastim flimkien ma' 5-Fluorouracil, juri li tista' tiżdied is-severita' ta' newtropenja.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Maltese: Il-proċedura ta' mobilizzazzjoni ta' PBPC trid tiġi kkunsidrata biss għal donaturi li jissodisfaw il-kriterji kliniċi u investigattivi kollha għad-donazjoni ta' PBPC.
English: Biograstim 30 MIU/0.5 mL solution for injection or infusion Filgrastim
Maltese: MIU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Filgrastim
English: Capillary leak syndrome*
Maltese: Sindromu ta' tnixxija talkapillari*
English: As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Maltese: B'Rizultat li hemm potenzjal li jirċievi dożi akbar u iktar spiss ta' dawn il-prodotti waqt kura b'filgrastim, jista' jkun hemm riskju għola li l-pazjent jiżviluppa tromboċitopenja u anemija.
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Maltese: Il-half-life ta' eliminazzjoni ta' filgrastim hija ta' madwar 3.5 siegħa, b'rata ta' tneħħija ta' madwar 0.6 mL/min/kg.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Maltese: Huwa rrakkomandat li jsiru investigazzjonijiet morfoloġiċi u ċitoġeniċi tal-mudullun fil-pazjenti b'intervalli regolari (madwar kull 12-il xahar).
English: 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.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq ilġeni u tolleranza lokali, ma juri l-ebda periklu speċjali għall-bnedmin.
English: TRM
Maltese: Lott
English: The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is
Maltese: Id-doża tal-bidu rakkomandata ta' filgrastim hija 0.1 MIU (1 μg)/kg/jum mogħtija ta' kuljum b'injezzjoni taħt il-ġilda u tiżdied b'iddozar sa massimu ta' 0.4
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μg)/kg/day given daily by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Maltese: MIU (5 μg)/kg/jum mogħtija bħala injezzjoni taħt il-ġilda ta' kuljum millewwel ġurnata wara t-tmiem tal-kimoterapija sakemm in-nadir mistenni jkun għadda u l-għadd ta' newtrofili jkun reġa' lura għan-normal.
English: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
Maltese: Kull siringa mimlija għal-lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f'0.8 mL soluzzjoni - Is-sustanzi l-oħra huma: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, ilma għall-injezzjoni.
English: Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection or infusion.
Maltese: Kull siringa mimlija għal-lest fiha 30 MIU (300 µg) filgrastim f'0.5 mL soluzzjoni għall-injezzjoni jew infużjoni.
English: Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection or infusion.
Maltese: Kull siringa mimlija għal-lest fiha 48 MIU (480 µg) filgrastim f'0.8 mL soluzzjoni għall-injezzjoni jew infużjoni.
English: Do not use any Biograstim that is left in the syringe.
Maltese: Biograstim huwa soluzzjoni ċar u mingħajr kulur.
English: Common (may affect up to 1 in 10 people): - reduction in blood platelets, which increases risk of bleeding or bruising; - headache; - diarrhoea; - enlargement of the liver; - hair loss; inflammation of blood vessels, often with skin rash; pain at the site of injection; rash; - loss of calcium from the bones; joint pain.
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna): id-dehra ta' leżjonijiet ibbuzzati, li jweġgħu, kulur aħmar skur fil-vjola fuq ir-riġlejn (xi drabi fil-wiċċ u fl-ghonq) u bid-deni (is-Sindromu ta' Sweet); aggravament ta' kundizzjonijiet rewmatiċi; uġigħ jew diffikulta biex tgħaddi l-awrina.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Maltese: Meta-analiżi ta' studji fuq trapjanti alloġeneiċi, li tinkludi r-riżultati ta' disa' provi prospettivi li fihom il-pazjenti ntagħżlu b'mod każwali, 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: For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell transplantation
Maltese: Prekawzjonijiet speċjali oħrajn Kawżi oħra ta' newtropenja transitorji bħal infezzjonijiet virali għandhom jiġu esklużi.
English: - It is important to contact your doctor immediately 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: - Hu importanti li tikkuntattja lit-tabib tiegħek immedjatament jekk ikollok xi wieħed minn dawn li ġejjin jew kombinazzjoni ta' l-effetti sekondarji li ġejjin: nefħa, li tista' tkun assoċjata ma' li persuna tagħmel l-awrina inqas frekwenti, diffikultà biex tieħu nifs, nefħa addominali u sensazzjoni li wieħed iħossu mimli, u sensazzjoni ġenerali ta' għeja.
English: The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Maltese: Id-doża tal-bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta' piż tal-ġisem, kuljum.
English: The following undesirable effects and their frequencies have been observed under treatment with filgrastim based on published information.
Maltese: L-effetti mhux mixtieqa li ġejjin u l-frekwenza tagħhom ġew osservati waqt kura b'filgrastim u huma bbażati fuq informazzjoni ppublikata.
English: CD34
Maltese: L-anzjani
English: Fatigue, generalised weakness
Maltese: Is-Sindrome ta' Sweet, vaskulite tal-ġilda
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medicinal product.
Maltese: L'użu ta' filgrastim f'pazjenti b'infezzjoni ta' HIV iżomm l-għadd ta' newtrofili normali sabiex jippermetti id-dożaġġ skedat tat-terapija antivirali u/jew mediċina majelosoppressiva oħra.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Maltese: Filgrastim għandu jitwaqqaf permanenti f'pazjenti li jkollhom reazzjoni allerġika serja.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Maltese: Donaturi li jirċievu kura b'G-CSF għal mobilizzazzjoni ta' PBPC jridu jkunu monitorjati sew sakemm il-parametri ematoloġiċi jergħu lura għan-normal.
English: Transformation to leukaemia or myelodysplastic syndrome
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Maltese: Disturbi vaskolari, fosthom mard veno-okklussiv u disturbi fil-volum tal-fluwidi, ġew irrapportati xi kultant f'pazjenti waqt kimoterapija b'doża għolja segwit bit-trapjant awtologu tal-mudullun.
English: 9/L, and a history of severe or recurrent infections, long absolute neutrophil count (ANC) of ≤ 0.5 x 10 term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Maltese: F'pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl-Għadd Assolut ta' Newtrofili (ANC) ta' ≤ 0.5 x 109/L, u storja ta' infezzjonijiet qawwija jew li jirkadu, it-terapija fit-tul b'Biograstim huwa indikat biex jiżdied l-għadd ta' newtrofili u sabiex l-inċidenza u t-tul ta' ġrajjiet avversi relatati ma' infezzjonijiet jonqsu.
English: During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Maltese: Waqt kura intermittenti b'dożi ta' 30 MIU (300 μg)/jum ta' filgrastim, l-ANC tal-pazjent jista' jitbiddel b'mod notevoli maż-żmien.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Maltese: Għal injezzjoni aktar komda, ħalli is-siringa mimlija għal-lest toqgħod għal 30 minuta sabiex tilħaq temperatura ambjentali, jew żomm is-siringa mimlija għal-lest delikatament f'idejk għal ftit minuti.
English: - Cough, fever and difficult or painful breathing can be signs of serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Maltese: - Sogħla, deni u diffikultà jew uġigħ biex tieħu n-nifs jistgħu jkunu sinjali ta 'effetti sekondarji pulmonari serji, bħal pnewmonja u sindromu respiratorju akut, li jistgħu jkunu fatali.
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Maltese: F'pazjenti b'newtropenja kronika u qawwija (SCN)
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, il-perjodu u l-kundizzjonijiet tal-ħażna qabel l-użu huma r-responsabilità ta' min jużah u normalment ma jkunx ta' iktar minn 24 siegħa f'temperatura ta' bejn 2°C - 8°C, sa kemm rrikostituzzjoni ma sseħħx f'kundizzjonijiet kontrollati u validati asettiċitament.
English: In other circumstances, additional leukaphereses are recommended.
Maltese: wara żewġ proċeduri ta' lewkafereżi.
English: 9/L to > 5.0 x 10
Maltese: Lewkafereżi jrid isir fil-perijodu meta l-ANC jitla' minn < 0.5 x 109/L sa > 5.0 x 109/L.
English: The needle will be covered by the protective sleeve so that you cannot prick yourself.
Maltese: Każijiet ta' protejnurja/ematurja kienu rari ħafna.
English: In clinical studies, > 90 % of patients responded reached and can be maintained (ANC > 2.0 x 10 at these doses, achieving reversal of neutropenia in a median of 2 days.
Maltese: Fi studji kliniċi, > 90% tal-pazjenti rrispondu b'dawn id-dożi, u kellhom taqlib ta' newtropenja f'medda ta' jumejn.
English: Discontinue filgrastim
Maltese: Bdil fid-doża ta' Filgrastim
English: Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Maltese: Filgrastim m'għandux jintuża f'pazjenti b'newtropenja konġenitali qawwija (is-sindromu ta' Kostman) b'abnormalitajiet ċitoġenetiċi (ara hawn taħt).
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
Maltese: L-esposizzjoni bi żball għal temperatura ta' friża ma jeffettwax ħażin l-istabilita` ta' Biograstim.
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 Summary of Product Characteristics of the specific chemotherapy agents used).
Maltese: Il-kawtela speċjali trid tiġi eżerċitata f'kura ta' pazjenti li qed jirċievu dożi għola ta' kimoterapija għax rispons aħjar tat-tumur ma ġiex stabbilit u dozi aktar qawwija ta' sustanzi kimoterapewtiċi jistgħu jwasslu għal tossiċita' żejda inkluż diturbi fil-qalb, fil-pulmun, fis-sistema nervuża u fil-ġilda (jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tas-sustanża kimoterapewtika speċifika li tintuża).
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Maltese: Kura b'filgrastim waħdu ma' jipprekludix l-iżvilupp ta' tromboċitopenja u anemija assoċjati mal-użu ta' prodotti mediċinali majelosoppressivi.
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Maltese: Effetti mhux mixtieqa oħrajn osservati jinkludu tkabbir tal-milza li, fil-minoranza tal-każi, jista' jkun progressiv, u tromboċitopenja.
English: Special precautions in SCN patients Blood cell counts
Maltese: Disturbi fil-kliewi u fis-sistema urinarja