FrancophonIA/ELRC3.0 huggingface dataset:
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-aktar reazzjonijiet avversi komuni rrappurtati huma deni, uġigħ muskoluskeletriku (li jinkludi uġigħ fl-għadam, uġigħ fid-dahar, artralġja, mijalġja, uġigħ f'estermitajiet, uġigħ muskoluskeletriku, uġigħ muskoluskeletriku fis-sider, uġigħ fl-għonq), anemija, rimettar u dardir.
English: Nivestim 48 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 96 million units [MU] (960 micrograms [µg]) of filgrastim*.
Maltese: Nivestim 48 MIU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Kull mL ta' soluzzjoni għall-injezzjoni jew infużjoni fih 96 miljun unità [MU] (960 mikrogramma [µg]) ta' filgrastim*.
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Maltese: Fi studji kliniċi, kien hemm frekwenza baxxa (madwar 3%) ta' sindromi mijelodisplastiċi (MDS, myelodisplastic syndrome) jew lewkimja f'pazjenti b' SCN ikkurati b'filgrastim.
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Il-glomerulonefrite ġiet irrappurtata f'pazjenti li kienu qed jirċievu filgrastim u pegfilgrastim.
English: Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Maltese: Ċitokini, Kodiċi ATC:
English: Nivestim 48 MU/0.5 ml injection/infusion filgrastim
Maltese: Nivestim 48 MU/0.5 mL injezzjoni/infużjoni filgrastim
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2. talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Maltese: Filgrastim jista' jingħata bħala infużjoni minn ġol-vina ta' 30 minuta jew ta' 24 siegħa jew għandu jingħata permezz ta' infużjoni ta' 24 siegħa kontinwa taħt il-ġilda.
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-vina (80 µg/kg/jum) ta' filgrastim lil fniek waqt il-perjodu ta' organoġenesi kien tossiku għallommijiet u żied l-abort spontanju, telf wara l-impjantazzjoni u tnaqqis fid-daqs medju tal-boton u tal-piż tal-fetu.
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 internazzjonali retrospettiv separat f'pazjenti b'lukemiji akuti u kroniċi, ma ġie osservat ebda effett fuq ir-riskju ta' GvHD, TRM u l-mortalità.
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 ġewx investigati f'donaturi b'saħħithom <16-il sena jew > 60 sena.
English: Special precautions in sickle cell trait and sickle cell disease
Maltese: Prekawzjonijiet speċjali f'pazjenti li għandhom karatteristika ta' sickle cell u l-marda ta' sickle cell
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Maltese: M'hemmx evidenza li pazjenti b'infezzjoni ta' HIV ikkurati b'filgrastim ikollhom żieda fir-replikazzjoni ta' HIV.
English: If required, Nivestim may be diluted in 5% glucose solution.
Maltese: Jekk ikun meħtieġ, Nivestim jista' jiġi dilwit f'soluzzjoni ta' 5% glucose.
English: • nose bleeds (epistaxis)
Maltese: • tinfaraġ (epistassi)
English: Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Maltese: Il-waqfien mill-kura ta' filgrastim is-soltu jġib tnaqqis ta' 50 % tan-newtrofili fid-demm fiż-żmien ġurnata jew tnejn, b'ritorn għall-livelli normali fi żmien 1 sa 7 ijiem.
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 mijelosoppressiva estensiva ma jkollhomx mobilizzazzjoni suffiċjenti ta' PBPC biex jaslu għall-għadd minimu rakkomandat (≥ 2.0 x 10
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 alloġeniċi tat-trapjanti, li jinkludu r-riżultati ta' disa provi prospettivi u każwali, 8 studji retrospettivi u studju wieħed b'kontrolli ma ġie osservat ebda effett fuq ir-riskji ta' G v HD akuta, G v HD kronika, jew mortalità relatata mat-trattament.
English: Pre-filled syringe
Maltese: Il-pazjenti kollha
English: • worsening of rheumatoid arthritis
Maltese: • taħrix tal-artrite rewmatika
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leucocyte counts rise to > 70 x 10
Maltese: Meta jingħata għall-mobilizzazzjoni ta' PBPC, kura b'filgrastim trid jitwaqqaf jew id-doża titniżżel jekk lgħadd ta' lewkoċiti jitla' għal > 70 x 10
English: Nivestim 30 MU/0.5 ml injection/infusion filgrastim
Maltese: Nivestim 30 MU/0.5 mL injezzjoni/infużjoni filgrastim
English: Transfusion reaction e a See section c (Description of selected adverse reactions).
Maltese: Ara sezzjoni c (Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Maltese: Kienet irrappurtata psewdogotta (chondrocalcinosis pyrophosphate) f'pazjenti bil-kanċer ittrattati b'filgrastim.
English: Hyperuricaemia Blood uric acid increased
Maltese: Iperurikemija Żieda tal-uric acid fid-demm
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati fis-sezzjoni 6.1.
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 flimkien ma' sinjali radjuloġiċi ta' infiltrati pulmonari u deterjorazzjoni tal-funzjoni tal-pulmun jistgħu jkunu sinjali talbidu tas-sindromu tad-diffikultà respiratorja akuta (ARDS - acute respiratory distress syndrome).
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: Myelodysplastic syndrome or Chronic myeloid leukaemia
Maltese: Sindromu majelodisplastiku jew Lewkimja majeloġenika kronika
English: 9/L for 3 more consecutive days
Maltese: 9/L għal 3 ijiem konsekuttivi
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 ta' sensittività eċċessiva, inklużi anafilassi, raxx, urtikarja, anġjoedema, qtugħ ta' nifs u pressjoni baxxa, li seħħew mal-bidu jew wara l-kura, ġew irrappurtati fi studji kliniċi u flesperjenza ta' wara t-tqegħid fis-suq.
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: Studji fuq l-użu ta' filgrastim f'pazjenti b'indeboliment sever tal-kliewi jew tal-fwied juru li l-profil farmakokinetiku u farmakodinamiku huwa simili għal dak f'individwi normali.
English: Use of UltraSafe Passive Needle Guard for Nivestim 30 MU/0.5 ml solution for injection/infusion and Nivestim 48 MU/0.5 ml solution for injection/infusion
Maltese: Meta tuża l-UltraSafe Needle Guard Passiva għal Nivstim 30 MU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni
English: Nivestim 12 MU/0.2 ml injection/infusion filgrastim
Maltese: Nivestim 12 MU/0.2 mL injezzjoni/infużjoni filgrastim
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: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs tal-milsa għandu jiġi mmonitorjat b'attenzjoni (eż. eżami kliniku, ultrasound).
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Maltese: Tagħtix filgrastim lil pazjenti bi storja medika ta' sensittività eċċessiva għal filgrastim jew pegfilgrastim.
English: Nivestim contains no preservative.
Maltese: Nivestim ma fih l-ebda preservattiv.
English: Gammaglutamyl transferase increased
Maltese: Żieda talaspartate aminotransferase Żieda tal-gammaglutamyl transferase
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Maltese: Sorbitol (E420) Polysorbate 80
English: 5 pre-filled syringes with 0.2 ml 8 pre-filled syringes with 0.2 ml 10 pre-filled syringes with 0.2 ml.
Maltese: 1 siringa mimlija lesta b'0.2 mL. 5 siringi mimlijin lesti b'0.2 mL. 8 siringi mimlijin lesti b'0.2 mL. 10 siringi mimlijin lesti b'0.2 mL.
English: Nivestim 12 MU/0.2 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Maltese: Nivestim 12 MIU/0.2 mL soluzzjoni għall-injezzjoni jew infużjoni Kull mL ta' soluzzjoni għall-injezzjoni jew infużjoni fih 60 miljun unità [MU] (600 mikrogrammi [µg]) ta' filgrastim*.
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-severità ta' newtropenja.
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Maltese: • nefħa u/jew fluwidu fil-pulmun (edema pulmonari)
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-dejta fit-tabelli t'hawn taħt tiddeskrivi r-reazzjonijiet avversi rrappurtati minn provi kliniċi u rappurtar spontanju.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Maltese: Ġew irrapportati xi każijiet tas-sindromu ta' Sweets (dermatożi akuta newtrofilika u bid-deni) f'pazjenti ttrattati b'filgrastim.
English: Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Maltese: Illivell tal-ebda effett avvers osservat (no observed adverse effect level) għal tossiċità embrijo-fetali f'dan l-istudju kienet ta' 10 µg/kg/jum, li kien jikkorispondi għal esponiment sistemiku ta' madwar 3-5 darbiet l-esponimenti osservati f'pazjenti trattati b'doża klinika.
English: • inflammation of the lungs (interstitial lung disease)
Maltese: • infjammazzjoni tal-pulmun (marda interstizjali tal-pulmun)
English: Granulocyte colony-stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimula l-kolonji ta' granuloċiti (Granulocyte-colony stimulating factor) jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
English: Leucocytosis
Maltese: Il-Belġju
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Maltese: Fil-provi kliniċi f'pazjenti bil-kanċer, l-uġigħ muskoluskeletriku kien ħafif jew moderat f'10 %, u sever fi 3 % tal-pazjenti.
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 10
Maltese: Irid jiġi kkunsidrat il-waqfien temporanju ta' kura jew it-tnaqqis fid-doża ta' filgrastim f'pazjenti b'newtropenja kronika u qawwija li jiżviluppaw tromboċitopenija (l-għadd tal-plejtlits < 100 x 10
English: This is known as a subcutaneous injection.
Maltese: Dan hu magħruf bħala injezzjoni sottokutanea.
English: added.
Maltese: Publikazzjoni
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)).
Maltese: Jekk inti pazjent b'newtropenija kronika severa, tista' tkun f'riskju li tiżviluppa kanċer tad-demm (lewkimja, sindrome mijelodisplastiku (MDS - myelodysplastic syndrome)).
English: A randomised, open-label, single-dose, comparator-controlled, two-way crossover study in 46 healthy volunteers showed that the pharmacokinetic profile of Nivestim was comparable to that of the reference product after subcutaneous and intravenous administration.
Maltese: Studju każwali b'tikketta tingħaraf, bil-komparatur bħala kontroll, inkroċjat fiż-żewġ direzzjonijiet li sar fuq 46 voluntier b'saħithom urew li l-profil farmakokinetiku ta' Nivestim kien komparabbli ma' dak tal-prodott ta' referenza kemm wara amministrazzjoni taħt il-ġilda kif ukoll ġol-vina.
English: • Risk management plan (RMP)
Maltese: • Pjan tal-immaniġġar tar-riskju (RMP)
English: Each pre-filled syringe contains 48 million units (MU) (480 g) of filgrastim in 0.5 ml (0.96 mg/ml)
Maltese: Kull siringa mimlija bil-lest fiha 48 million unità (MU) (480 µg) ta' filgrastim f'0.5 mL (0.96 mg/mL)
English: Kidney injury has been seen in patients who received filgrastim.
Maltese: Feriti fil-kliewi dehru f'pazjenti li rċivew filgrastim.
English: Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain.
Maltese: Tinkludi uġigħ fl-għadam, uġigħ fid-dahar, artralġja, mijalġja, uġigħ fl-estremitajiet, uġigħ muskoluskeletriku, uġigħ muskoluskeletriku fis-sider, uġigħ fl-għonq.
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: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Maltese: • uġigħ sever fl-għadam, fis-sider, fl-imsaren jew fil-ġogi (anemija tas-Sickle Cells bi kriżi)
English: Dysuria Haematuria
Maltese: Disturbi vaskulari
English: Diluted filgrastim may be adsorbed to glass and plastic materials unless it is diluted in 5% glucose solution (see section 6.6).
Maltese: Filgrastim dilwit jista' jiġi adsorbit fuq il-ħġieġ jew materjal tal-plastik sakemm ma jkunx ġie dilwit f'soluzzjoni ta' 5% glucose (ara sezzjoni 6.6).
English: Each pre-filled syringe contains 48 million units (MU) (480 micrograms [µg]) of filgrastim in 0.5 ml (0.96 mg/ml).
Maltese: Kull siringa mimlija lesta fiha 48 miljun unità (MU) (480 mikrogramma [µg]) ta' filgrastim f'0.5 mL (0.96 mg/mL).
English: Special precautions in patients undergoing PBPC mobilisation
Maltese: Prekawzjonijiet speċjali f'pazjenti taħt proċedura ta' mobilizzazzjoni ta' PBPC
English: Acute respiratory distress syndrome a
Maltese: Sindromu taddiffikultà respiratorja akuta Falliment respiratorju Edema pulmonari Emorraġija pulmonari Marda interstizjali talpulmuna
English: EU/1/10/631/004 EU/1/10/631/005 EU/1/10/631/006 EU/1/10/631/011
Maltese: EU/1/10/631/005 EU/1/10/631/006 EU/1/10/631/011
English: Pregnancy
Maltese: Emoptożi
English: In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10
Maltese: F'pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl-għadd assolut ta' newtrofili (ANC) ta'  0.5 x 10
English: Nivestim 30 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Maltese: Nivestim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Kull mL ta' soluzzjoni għall-injezzjoni jew infużjoni fih 60 miljun unità [MU] (600 mikrogramma [µg]) ta' filgrastim*.
English: Pfizer ΕΛΛΑΣ Α.Ε.
Maltese: Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch)
English: Each pre-filled syringe contains 30 million units (MU) (300 micrograms [µg]) of filgrastim in 0.5 ml (0.6 mg/ml).
Maltese: Kull siringa mimlija lesta fiha 30 miljun unità (MU) (300 mikrogramma [µg]) ta' filgrastim f'0.5 mL (0.6 mg/mL).
English: Other medicines and Nivestim
Maltese: Mediċini oħra u Nivestim
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c).
Maltese: Kien hemm rapporti ta' GvHD u mwiet f'pazjenti wara t-trapjant alloġeniku tal-mudullun (ara sezzjoni c).
English: Haemoptysis Dyspnoea Cough a
Maltese: Reazzjoni għattrasfużjoni a
English: Each pre-filled syringe contains 12 million units (MU) (120 micrograms [µg]) of filgrastim in 0.2 ml (0.6 mg/ml).
Maltese: Kull siringa mimlija lesta fiha 12-il miljun unità (MU) (120 mikrogramma [µg]) ta' filgrastim f'0.2 mL (0.6 mg/mL).
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Maltese: Każijiet ta' tnaqqis ta' densità tal-għadam u ta' osteoporożi ġew rapportati f'pazjenti pedjatriċi b'newtropenija severa kronika li kienu qed jirċievu kura kronika b'filgrastim.
English: Pain a
Maltese: ANNESS I
English: • trouble sleeping (insomnia)
Maltese: • diffikultà biex torqod (insomnja)
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk filgrastim/metaboliti jiġux eliminati fil-ħalib tal-bniedem.
English: • A new pre-filled syringe of Nivestim.
Maltese: • Siringa ġdida mimlija lesta ta' Nivestim.
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 fit-tfal li qed jirċievu kimoterapija ċitotossika
English: One retrospective European study evaluating the use of GCSF 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 GCSF was administered.
Maltese: Studju retrospettiv Ewropew li evalwa l-użu ta' G-CSF wara trapjant alloġeniku tal-mudullun f'pazjenti b'lukemiji akuti jissuġerixxi żieda fir-riskju ta' GvHD, mortalità relatata mat-trattament (TRM) u mortalità meta ngħata
English: • rejection of transplanted bone marrow (graft versus host disease)
Maltese: • rifjut tal-mudullun trapjantat (marda tal-graft kontra l-ospitu)
English: Please tell your doctor immediately during treatment: - 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 jogħġbok għid lit-tabib tiegħek immedjatament waqt il-kura: - jekk ikollok reazzjoni allerġika inkluż dgħufija, tnaqqis fil-pressjoni tad-demm, diffikultà sabiex tieħu nifs, nefħa tal-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa tal-wiċċ, taxxufftejn, tal-ħalq, tal-ilsien jew tal-gerżuma (anġjodema) u qtugħ ta' nifs (dispnea). - jekk ikollok sogħla, deni jew diffikultà sabiex tieħu nifs (dispnea) minħabba li dan jista' jkun sinjal ta' Sindrome tad-Diffikultà Respiratorja Akuta (ARDS - Acute Respiratory Distress Syndrome). - jekk ikollok feriti fil-kliewi (glomerulonefrite).
English: • nausea
Maltese: • sturdament
English: For maintaining normal neutrophil counts:
Maltese: Newtropenja konġenitali:
English: Cutaneous vasculitis
Maltese: Marda venookklussiva
English: • unusual hair loss or thinning (alopecia)
Maltese: • tisgħol id-demm (emoptisi)
English: Each pre-filled syringe contains 12 million units (MU) (120 g) of filgrastim in 0.2 ml (0.6 mg/ml)
Maltese: Kull siringa mimlija bil-lest fiha 12-il miljun unità (MU) (120 µg) ta' filgrastim f'0.2 mL (0.6 mg/mL)
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Maltese: Lewkoċitosi (WBC > 50 x 10 9/L) ġiet osservata f'41 % tad-donaturi normali waqt li tromboċitopenja transitorja (plejtlits < 100 x 10 9/L) ġiet osservata f'35% tad-donaturi wara filgrastim u lewkafereżi (ara sezzjoni 4.4).
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
Maltese: Fi studji kliniċi u fl-ambjent ta' wara t-tqegħid fis-suq, effetti avversi pulmonari, fosthom mard interstizjali tal-pulmun, edema pulmonari, u infiltrazzjonijiet tal-pulmun ġew irrappurtati fejn ftit minnhom irriżultaw f'falliment respiratorju jew f'sindromu tad-diffikultà respiratorja akuta (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4)
English: Nivestim 12 MU/0.2 ml solution for injection/infusion filgrastim
Maltese: Nivestim 12 MU/ 0.2 mL soluzzjoni għall-injezzjoni/infużjoni filgrastim
English: EU/1/10/631/001 EU/1/10/631/002 EU/1/10/631/003 EU/1/10/631/004 EU/1/10/631/005 EU/1/10/631/006 EU/1/10/631/007 EU/1/10/631/008 EU/1/10/631/009 EU/1/10/631/010 EU/1/10/631/011 EU/1/10/631/012
Maltese: EU/1/10/631/005 EU/1/10/631/006 EU/1/10/631/007 EU/1/10/631/008 EU/1/10/631/009 EU/1/10/631/010
English: Effect of chemotherapy on erythrocytes and thrombocytes
Maltese: Effett tal-kimoterapija fuq eritroċiti u tromboċiti
English: The subcutaneous route is preferred in most cases.
Maltese: Ir-rotta taħt ilġilda hija ppreferuta f'ħafna każijiet.
English: Pyrexia
Maltese: • rimettar
English: Each pre-filled syringe contains 30 million units (MU) (300 g) of filgrastim in 0.5 ml (0.6 mg/ml)
Maltese: Kull siringa mimlija bil-lest fiha 30 miljun unità (MU) (300 µg) ta' filgrastim f'0.5 mL (0.6 mg/mL)
English: Nivestim 48 MU/0.5 ml solution for injection/infusion filgrastim
Maltese: Nivestim 48 MU/ 0.5 mL soluzzjoni għall-injezzjoni/ infużjoni filgrastim