FrancophonIA/ELRC3.0 huggingface dataset:
English: Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis)
Maltese: Sindrome ta' Sweet (dermatosi newtrofilika febbrili akuta)
English: Diarrhoeaa, e Vomitinga, e Nauseaa
Maltese: Dijareaa, e Rimettara, e Dardira
English: Transfusion reactione a See section c (Description of selected adverse reactions)
Maltese: Reazzjoni tat trasfużjonie a Ara sezzjoni c (Deskrizzjoni ta' reazzjonijiet avversi magħżula)
English: Filgrastim HEXAL contains sorbitol (E420).
Maltese: Filgrastim HEXAL fih sorbitol (E420).
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4).
Maltese: Lewkoċitożi (WBC > 50 x 109/l) ġiet osservata f'41% tad-donaturi normali u tromboċitopenija temporanja (plejtlits < 100 x 109/l) wara filgrastim u lewkafereżi ġiet osservata f'35% tad-donaturi
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Maltese: F'firien tqal, ma ġiet osservata l-ebda tossiċità materna jew fetali f'dożi sa 575 µg/kg/kuljum.
English: Permanently discontinue Filgrastim HEXAL in patients with clinically significant hypersensitivity.
Maltese: Waqqaf b'mod permanenti Filgrastim HEXAL f'pazjenti b'sensittività eċċessiva klinikament sinifikanti.
English: In patients with severe chronic neutropenia (SCN)
Maltese: F'pazjenti b'newtropenja kronika severa (SCN)
English: (Sweets syndrome)
Maltese: Syndrome).
English: Rare (≥ 1/10,000 to
Maltese: (≥1/10,000 sa
English: • rejection of transplanted bone marrow (graft versus host disease)
Maltese: • rifjut tal-mudullun ittrapjantat (Graft versus Host Disease)
English: Sweets syndrome
Maltese: Sindrome ta' Sweet
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC Code: L03AA02
Maltese: Immunostimulanti, fatturi li jistimulaw il-kolonji, Kodiċi ATC:
English: Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420).
Maltese: Eċċipjenti: glutamic acid, polysorbate 80, ilma għall-injezzjonijiet u sorbitol (E420).
English: Pseudogout (chondrocalcinosis pyrophosphate)
Maltese: Psewdogotta (Pirofosfat kondrokali-kinosi)
English: In clinical trials, 97% of patients who responded had a complete response at doses ≤ 24 μg/kg/day.
Maltese: Fi provi kliniċi, 97% tal-pazjenti li rrispondew kellhom rispons sħiħ f'dożi ≤ 24 μg/kg/kuljum.
English: Splenomegalya Haemoglobin decreasede
Maltese: Splenomegalijaa Tnaqqis flemoglobinae
English: Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' 1, 3, 5 jew 10 siringi mimlija għal-lest.
English: - Mobilisation of peripheral blood progenitor cells (PBPCs).
Maltese: - Il-mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali (PBPCs).
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim ma kinux evalwati f'donaturi normali ta' < 16-il sena jew ta' > 60 sena.
English: Filgrastim HEXAL can be used:
Maltese: Filgrastim HEXAL jista' jintuża:
English: Example: In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 μg) should be given with 0.2 ml of human serum albumin 200 mg/ml (20%) solution Ph. Eur.
Maltese: F'volum finali 20 ml, dożi totali ta' filgrastim inqas minn 30 MU (300 μg) għandhom jingħataw ma' soluzzjoni ta' 0.2 ml ta' albumina tas-serum uman (Ph. Eur.) 200 mg/ml (20%).
English: Filgrastim HEXAL 48 MU/0.5 ml
Maltese: INFORMAZZJONI BIL-BRAILLE Filgrastim HEXAL 48 MU/0.5 ml
English: Filgrastim HEXAL is a biosimilar medicinal product.
Maltese: Filgrastim HEXAL huwa prodott mediċinali bijoloġiku simili.
English: Acute respiratory distress syndromea Respiratory failurea
Maltese: Sindrome ta' problemi respiratorji akutia
English: Astheniaa Malaisee Oedema peripherale
Maltese: Astenja Telqa Edema periferalie
English: Each pre-filled syringe contains 48 million units (equivalent to 480 micrograms) filgrastim in 0.5 ml (96 MU/ml).
Maltese: Kull siringa mimlija għal-lest fiha 48 miljun unità (ekwivalenti għal 480 mikrogramma) ta' filgrastim f'0.5 ml (96 MU/ml).
English: Reduce to 0.5 MU/kg/day (5 μg/kg/day)
Maltese: MU/kg/kuljum (5 μg/kg/kuljum)
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 may be preliminary signs of acute respiratory distress syndrome (ARDS).
Maltese: Il-bidu ta' sinjali pulmonari, bħal sogħla, deni u qtugħ ta' nifs b'rabta ma' sinjali radjoloġiċi ta' infiltrati pulmonari u deterjorament fil-funzjoni pulmonari, jistgħu jkunu sinjali preliminari ta' Sindrome ta' Problemi Respiratorji Akuti (ARDS - Acute Respiratory Distress
English: Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation Publication
Maltese: Riskju Relattiv (95% CI) ta' GvHD u TRM
English: Transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Maltese: Tromboċitopenja temporanja (plejtlits < 100 x 109/l) wara l-għoti ta' filgrastim u lewkaferesi kienet osservata f'35% tal-pazjenti studjati.
English: Risk associated with increased doses of myelosuppressive medicinal products
Maltese: Riskju assoċjat ma' żieda fid-dożi ta' prodotti mediċinali majelsoppressivi
English: Prior exposure to cytotoxic agents 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 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Maltese: Pazjenti li kellhom terapija majelosoppressiva estensiva ħafna fil-passat, jistgħu ma jurux mobilizzazzjoni suffiċjenti ta' PBPC biex jiksbu l-ammont minimu rakkomandat (≥ 2.0 x 106 CD34+ ċelluli/kg) jew l-aċċelerazzjoni tal-irkuprar tal-plejtlits għall-istess grad.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Maltese: G-CSF jista' jippromwovi t-tkabbir ta' ċelluli majelojde in vitro, u effetti simili jistgħu jiġu osservati fuq xi ċelluli mhux majelojde in vitro.
English: • bumpy skin rash (rash macuo-papular)
Maltese: • raxx tal-ġilda b'ħotob (raxx makuo-papulari)
English: In view of the possible risk of microbial contamination, Filgrastim HEXAL syringes are for single use only.
Maltese: Minħabba r-riskju possibbli ta' kontaminazzjoni mikrobjali, is-siringi b'Filgrastim HEXAL jintużaw darba biss.
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Maltese: L-iktar reazzjonijiet avversi serji li jistgħu jseħħu waqt kura b'Filgrastim jinkludu: reazzjoni anafilattika, avvenimenti avversi pulmonari serji (inklużi pnewmonja interstizjali u ARDS), sindromu ta' tnixxija tal-kapillari, splenomegalija/qsim tal-milsa severi, trasformazzjoni għal sindrome majelodisplastiku jew lewkemija f'pazjenti b'SCN, GvHD f'pazjenti li qed jirċievu trasferiment tal mudullun alloġeniku jew trapjant taċ-ċelluli proġenituri taċ-ċelluli tad-demm periferali u kriżijiet taċċelluli sickle f'pazjenti bil-marda taċ-ċelluli sickle.
English: Decreased Appetitee Blood lactate dehydrogenase increased
Maltese: Żieda ta' lactate dehydrogenase fid-demm
English: When diluted in glucose 50 mg/ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Maltese: Meta jkun dilwit f'soluzzjoni ta' 50 mg/ml (5%) ta' glucose, filgrastim hu kompatibbli mal-ħġieġ u ma' varjetà ta' plastiks li jinkludu polyvinylchloride, polyolefin (copolymer ta' polypropylene u polyethylene) u polypropylene.
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.4 and 5.1).
Maltese: Kien hemm rapporti ta' GvHD u fatalitajiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeneiku tal-mudullun (ara sezzjoni 4.4 u 5.1). d.
English: A single subcutaneous dose of 0.5 MU/kg (5 µg/kg) resulted in maximum serum concentrations after a tmax of 4.5 ± 0.9 hours (mean ± SD).
Maltese: MU/kg (5 µg/kg) irriżultat f'konċentrazzjonijiet massimi fis-serum wara tmax ta' 4.5 ± 0.9 sigħat (medja ± SD).
English: In randomised clinical trials, a subcutaneous dose of 230 μg/m2/day (4.0 to 8.4 μg/kg/day) was used.
Maltese: Fi studji kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali intużat doża taħt il-ġilda ta' 230 μg/m2/kuljum (4.0 sa 8.4 μg/kg/kuljum).
English: Hypersensitivity Drug hypersensitivitya Graft versus host diseaseb
Maltese: Graft versus Host Diseaseb
English: Leukocytosisa
Maltese: Lewkoċitosia
English: If required, Filgrastim HEXAL may be diluted in glucose 50 mg/ml (5%) solution.
Maltese: Jekk ikun meħtieġ, Filgrastim HEXAL jista' jiġi dilwit f'soluzzjoni ta' 50 mg/ml (5%) ta' glucose.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
Maltese: Il-lewkaferesi għandha titwettaq matul il-perjodu meta l-ANC jitla' minn < 0.5 x 109/l għal > 5.0 x 109/l.
English: Musculoskeletal painc
Maltese: Uġigħ muskolo skeletriku ċ
English: Filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Maltese: soluzzjoni ta' 5% ta' glucose (ara sezzjoni 6.6).
English: Aspartate aminotransferase increased Gammaglutamyl transferase increased
Maltese: Żieda ta' gamma glutamyl transferase
English: Dilution to a final concentration < 0.2 MU/ml (2 μg/ml) is not recommended at any time.
Maltese: Id-dilwizzjoni għal konċentrazzjoni finali ta' < 0.2 MU/ml (2 μg/ml) mhijiex rakkomandata fi kwalunkwe ħin.
English: 1 pre-filled syringe without needle safety guard 3 pre-filled syringes without needle safety guard 5 pre-filled syringes without needle safety guard 10 pre-filled syringes without needle safety guard
Maltese: 1 siringa mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra 3 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra 5 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra 10 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Maltese: Il-grad ta' varjazzjoni bejn pazjenti individwali u bejn l-assaġġi tal-laboratorju ta' ċelluli CD34+ ifisser li paragun dirett bejn studji differenti hu diffiċli.
English: - The active substance is filgrastim.
Maltese: X'fih Filgrastim HEXAL - Is-sustanza attiva hi filgrastim.
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Maltese: L-iktar reazzjonijiet avversi komuni li ġew irrappurtati huma deni, uġigħ muskoloskeletriku (li jinkludu wġigħ fl-għadam, uġigħ fid-dahar, artralġja, mijalġja, uġigħ fl-estremitajiet, uġigħ muskoloskeletriku, uġigħ muskoloskeletriku fis-sider, uġigħ fl-għonq), anemija, rimettar, u nawseja.
English: Dizziness may occur following the administration of filgrastim (see section 4.8).
Maltese: Sturdament jista' jseħħ wara l-għoti ta' filgrastim (ara sezzjoni 4.8).
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Maltese: Metodu ta' kif għandu jingħata Filgrastim jista' jingħata bħala injezzjoni ta' kuljum taħt il-ġilda jew bħala infużjoni ta' kuljum ġol-vini dilwita f'5% ta' soluzzjoni tal-glucose mogħtija fuq perjodu ta' 30 minuta (ara sezzjoni 6.6).
English: Filgrastim HEXAL must not be diluted with sodium chloride solution.
Maltese: Filgrastim HEXAL m'għandux jiġi dilwit b'soluzzjonijiet ta' sodium chloride.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Maltese: Prekawzjonijiet speċjali f'reċipjenti tal-PBPCs alloġeneiċi mobilizzati b'filgrastim
English: Filgrastim for PBPC mobilisation when used alone:
Maltese: Filgrastim għal mobilizzazzjoni tal-PBPC meta jintuża waħdu:
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Maltese: Sotto-sett ta' madwar 12% tal-pazjenti li kellhom evalwazzjonijiet ċitoġeniċi normali fil-linja bażi, sussegwentement instab li kellhom anormalitajiet, li kienu jinkludu monosomija 7, meta saret ir-ripetizzjoni tal-evalwazzjoni ta' rutina.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/l.
Maltese: Meta jingħata għal mobilizzazzjoni tal-PBPC, filgrastim għandu jitwaqqaf jew id-dożaġġ tiegħu għandu jitnaqqas jekk l-għadd tal-lewkoċiti jitla' għal > 70 x 109/l.
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
Maltese: Fi studji kliniċi u wara t-tqegħid fis-suq, reazzjonijiet pulmonari avversi li kienu jinkludu mard interstizjali tal-pulmun, edema pulmonari, u infiltrazzjoni tal-pulmun, ġew irrappurtati f'xi każijiet b'riżultat ta' waqfien tan-nifs jew sindrome ta' problemi respiratorji akuti, li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: How to store Filgrastim HEXAL
Maltese: Tużax Filgrastim HEXAL
English: The median serum elimination half-life (t1/2) of filgrastim after single subcutaneous doses ranged from 2.7 hours (1.0 MU/kg, 10 µg/kg) to 5.7 hours (0.25 MU/kg, 2.5 µg/kg) and was prolonged after 7 days of dosing to 8.5 - 14 hours, respectively.
Maltese: MU/kg, 2.5 µg/kg) u twal wara 7 ijiem ta' dożaġġ għal 8.5 - 14-il siegħa, rispettivament.
English: Transformation to leukaemia or myelodysplastic syndrome
Maltese: It-trasformazzjoni għal-lewkimja jew għas-sindrome majelodisplastiku
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious disease.
Maltese: Il-mobilizzazzjoni tal-PBPC għandha tiġi kkunsidrata biss f'donaturi li jissodisfaw il-kriterji tal-eliġibilità normali kliniċi u tal-laboratorju għal donazzjoni ta' ċelluli staminali, b'attenzjoni speċjali għall-valuri ematoloġiċi u mard infettiv.
English: Veno-occlusive diseased
Maltese: Mard venookklużivd
English: Each pre-filled syringe contains 30 million units (equivalent to 300 micrograms) filgrastim in 0.5 ml (60 MU/ml).
Maltese: Kull siringa mimlija għal-lest fiha 30 miljun unità (ekwivalenti għal 300 mikrogramma) ta' filgrastim f'0.5 ml (60
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Maltese: Ir-rakkomandazzjoni ta' ammont prodott minimu ta' ≥ 2.0 x 106 CD34+ ċelluli/kg hu bbażat fuq esperjenza ppubblikata li tirriżulta f'rikostituzzjoni ematoloġika adegwata.
English: Blood glucose decreased Pseudogouta (Chondrocalcinosis Pyrophosphate) Fluid volume disturbances
Maltese: (Pirofosfat kondrokalikinosi) Disturbi fil-volum tal-fluwidi
English: Do not administer Filgrastim HEXAL to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Maltese: Tagħtix Filgrastim HEXAL lil pazjenti bi storja medika ta' sensittività eċċessiva għal filgrastim jew pegfilgrastim.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
Maltese: .2 Tagħrif farmakokinetiku Studji crossover, randomised, double-blind, dwar dożi waħidhom u dożi multipli li saru fuq 204 voluntiera b'saħħithom, urew li l-profil farmakokinetiku ta' Filgrastim HEXAL kien komparabbli ma' dak tal-prodott tar-referenza wara l-għoti taħt il-ġilda u l-għoti ġol-vini.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Maltese: Frieħ tal-firien mogħtija filgrastim matul il-perjodi immedjatament qabel u wara t-twelid u t-treddigħ, urew dewmien fid-differenzjazzjoni esterna u dewmien fit-tkabbir (≥20 µg/kg/kuljum) u r-rata ta' sopravivenza ftit imnaqqsa (100 µg/kg/kuljum).
English: • trouble sleeping (insomnia)
Maltese: • problemi biex torqod (insomnja)
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Maltese: • jekk ikollok reazzjoni allerġika li tinkludi dgħufija, tnaqqis fil-pressjoni tad-demm, diffikultà biex tieħu n-nifs, nefħa tal-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa tal-wiċċ u tax-xufftejn, tal-ħalq, tal-ilsien jew tal-gerżuma (anġjoedema) u qtugħ ta' nifs
English: Acute myeloid leukaemia
Maltese: Lewkemija majelojde akuta
English: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
Maltese: Mediċini bħal melphalan, carmustine (BCNU) u carboplatin, meta jingħataw fuq perjodi twal ta' żmien qabel ma wieħed jipprova l-mobilizzazzjoni tal-proġenituri, jistgħu jnaqqsu l-ammont tal-proġenituri.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Maltese: • livelli għolja ta' uric acid fid-demm, li jistgħu jikkawżaw il-gotta (iperuriċemija) (Żieda ta' uric acid fid-demm)
English: Renal and urinary disorders
Maltese: Anormalitajiet urinarji
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà 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 l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini. D.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and foetal weight were observed.
Maltese: L-għoti ġol-vini (80 µg/kg/kuljum) ta' filgrastim lil fniek matul il-perjodu ta' organoġenesi kien tossiku għall-omm u żied l-aborti spontanji, telf wara l-impjantazzjoni, u ġew osservati tnaqqis fil-medja tan-numru ta'
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Maltese: Każijiet tas-Sindrome ta' Sweet (dermatożi newtrofilika febbrili akuta) ġew irrappurtati f'pazjenti kkurati b'filgrastim.
English: Filgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Maltese: MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest Kull ml ta' soluzzjoni fih 60 miljun unità (MU) (ekwivalenti għal 600 mikrogramma [μg]) ta'
English: Diluted filgrastim may be adsorbed to glass and plastic materials, unless it is diluted in glucose 50 mg/ml (5%) solution (see section 6.6).
Maltese: Filgrastim dilwit jista' jkun adsorbit mal-ħġieġ u materjali tal-plastik, ħlief jekk ikun dilwit f'soluzzjoni ta' 50 mg/ml (5%) ta' glucose (ara sezzjoni 6.6).
English: • upper respiratory tract infection
Maltese: Insuffiċjenza respiratorjaa Edema pulmonaria
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Maltese: Għandha tingħata konsiderazzjoni għal twaqqif temporanju jew it-tnaqqis tad-doża ta' filgrastim f'pazjenti b'newtropenja kronika severa li jiżviluppaw tromboċitopenja (għadd tal-plejtlits ta' < 100 x 109/l).
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Maltese: L-użu ta' filgrastim għall-mobilizzazzjoni tal-PBPCs f'donaturi normali qabel it-trapjant alloġeneiku tal-PBPC
English: - In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Maltese: - F'pazjenti, tfal jew adulti b'newtropenja severa konġenitali, ċiklika, jew idjopatika b'għadd assolut tan-newtrofili (ANC) ta' ≤ 0.5 x 109/l, u storja medika ta' infezzjonijiet severi jew rikorrenti, l-għoti fit-tul ta' filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' żmien ta' avvenimenti assoċjati mal-infezzjoni.
English: Paediatric SCN patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Special precautions in normal donors undergoing PBPC mobilisation
Maltese: Prekawzjonijiet speċjali f'donaturi normali li tkun qed issirilhom mobilizzazzjoni tal-PBPC
English: Filgrastim HEXAL is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Maltese: Filgrastim HEXAL hu disponibbli f'pakketti li fihom 1, 3, 5 jew 10 siringi mimlija għal-lest b'labra tal-injezzjoni bi jew mingħajr protezzjoni tas-sigurtà tal-labra.
English: Other medicines and Filgrastim HEXAL
Maltese: Mediċini oħra u Filgrastim HEXAL
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Maltese: In-newtrofili prodotti b'rispons għal filgrastim juru funzjoni normali jew imtejba kif muri minn testijiet tal-funzjoni kemotattika u fagoċitika.
English: The observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3 - 5 times the exposures observed in patients treated with the clinical dose.
Maltese: li jikkorrispondi għal esponiment sistemiku ta' madwar 3 - 5 darbiet tal-esponimenti osservati f'pazjenti kkurati bid-doża klinika.