FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Polysorbate 80
Maltese: Sorbitol (E420) Polysorbate 80
English: Solution for injection/infusion 1 pre-filled syringe (0.5 mL) 5 pre-filled syringes (0.5 mL)
Maltese: Soluzzjoni għall-injezzjoni/infużjoni 1 siringa mimlija għal-lest b'0.5 mL 5 siringi mimlija għal-lest b'0.5 mL
English: Magyarország STADA Arzneimittel AG Telephone +49/6101.603.0
Maltese: Magyarország STADA Arzneimittel AG Tel.: +49/6101.603.0
English: Acute myeloid leukaemia
Maltese: Lewkimja majelojde akuta
English: Each pre-filled syringe contains 48 MU (480 μg) filgrastim in 0.5 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 48 MU (480 μg) filgrastim f'0.5 mL ta' soluzzjoni.
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 gotta (iperurikemija) (żieda ta' uric acid fid-demm
English: Grastofil treatment will last for 4 to 5 days.
Maltese: Il-kura b'Grastofil se ddum għal 4 sa 5 ijiem.
English: The safety and efficacy of filgrastim has not been assessed in normal donors less than 16 years or greater than 60 years of age.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim ma ġewx evalwati f'donaturi normali li kellhom inqas minn 16-il sena jew iktar minn 60 sena.
English: Capillary leak syndrome
Maltese: Sindrome majelodisplastika jew Lewkimja majelojda kronika
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: Il-frieħ talfirien li ngħataw filgrastim matul il-perjodi ta' qabel it-twelid u tat-treddigħ, urew dewmien fiddifferenzazzjoni esterna u dewmien fit-tkabbir (≥ 20 μg/kg/jum) u naqqsu xi ftit ir-rata ta' sopravivenza (100 μg/kg/jum).
English: Congenital neutropenia: the recommended starting dose is 1.2 MU/kg/day (12 micrograms/kg/day) as a single dose or in divided doses.
Maltese: Newtropenija konġenitali: id-doża tal-bidu rakkomandata hi ta' 1.2 MU/kg/jum (12-il mikrogrammi/kg/jum) bħala doża waħda jew f'dożi maqsumin.
English: STADA Arzneimittel AG Telephone +49/6101.603.0
Maltese: STADA Arzneimittel AG Tel +49/6101.603.0
English: Telephone +386/1-589.67.10
Maltese: Tel:+ 386/1-589.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni fih 60 miljun unità (MU) (ekwivalenti għal 600 mikrogramma [μg]) ta' filgrastim.
English: ANNEX I
Maltese: TAS-SUSTANZA/I
English: For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms).
Maltese: Pereżempju, jekk tiżen 60 kilogramm, id-doża tiegħek ta' kuljum se tkun ta' 60 miljun unità (600 mikrogramma).
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 tal-eliminazzjoni fis-serum ta' filgrastim hi ta' madwar 3.5 sigħat, b'rata ta' tneħħija ta' madwar 0.6 mL/min/kg.
English: Grastofil 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: Grastofil jista' jingħata bħala injezzjoni ta' kuljum taħt il-ġilda jew bħala infużjoni ta' kuljum ġol-vini dilwit f'soluzzjoni ta' 5% ta' glucose mogħtija fuq 30 minuta (ara sezzjoni 6.6).
English: It is supplied in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Maltese: Huwa fornut f'siringa mimlija għal-lest, mmarkati bi 1/40 marki stampati minn 0.1 mL għal 1 mL fuq is-siringa, ma 'labra tal-injezzjoni.
English: Grastofil may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Maltese: Grastofil jista' jingħata bħala infużjoni ġol-vini ta' 30 minuta jew fuq perjodu ta' 24 siegħa, jew jingħata bħala infużjoni kontinwa taħt il-ġilda fuq perjodu ta' 24 siegħa.
English: The recommendation of a minimum yield of ≥ 2.0 x 10
Maltese: Ir-rakkomandazzjoni ta' ammont prodott minimu ta' ≥ 2.0 x 10
English: For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Maltese: MU (15 µg) kull mL, lalbumina fis-serum uman (HSA) għandha tiġi miżjuda għal konċentrazzjoni finali ta' 2 mg/mL.
English: In clinical studies and the post-marketing setting pulmonary adverse reactions 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: Fl-istudji kliniċi u fl-ambjent ta' wara t-tqegħid fis-suq, reazzjonijiet avversi pulmonari li kienu jinkludu marda tal-interstizju tal-pulmun, edima pulmonari, u infiltrazzjoni fil-pulmun ġew irrappurtati f'xi każijiet b'riżultat ta' waqfien tan-nifs jew sindrome ta' problemi respiratorji akuti (ARDS - acute respiratory distress syndrome), li jistgħu jkunu fatali (ara sezzjoni 4.4).
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 l-istudji kliniċi, ikkurati b'filgrastim.
English: Telephone +421/2-5262.1933
Maltese: Slovenská republika STADA PHARMA Slovakia s.r.o. Tel: +421/2-5262.1933
English: 9/L) following filgrastim treatment and leukapheresis was observed in 35% of donors (see section 4.4).
Maltese: 9/L) wara trattament b'filgrastim u lewkafereżi ġiet osservata f'35%
English: Blood uric acid increased
Maltese: Żieda tal-uric acid fiddemm
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 dwar filgrastim f'pazjenti b'indeboliment sever tal-funzjoni tal-kliewi jew tal-fwied juru li filgrastim juri profil farmakokinetiku u farmakodinamiku li hu simili għal dak li jiġi osservat f'individwi normali.
English: In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 10
Maltese: Fi studji kliniċi, dożaġġ bi 30 MU/jum (300 mikrogramma/jum) fuq perjodu ta' 1-7 ijiem kull ġimgħa kien meħtieġ biex iżomm l-ANC f' > 2.0 x 10
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: Fi tfal u adulti b'newtropenija severa konġenitali, ċiklika, jew idjopatika, b'għadd assolut tannewtrofili (ANC) ta' ≤ 0.5 x 10
English: In clinical studies in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Maltese: Fi studji kliniċi f'pazjenti bil-kanċer, l-uġigħ muskoluskeletriku kien ħafif jew moderat f'10%, u sever fi 3% tal-pazjenti.
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Glomerulonefrite ġiet irrappurtata f'pazjenti li kienu qed jirċievu filgrastim u pegfilgrastim.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Maltese: Ma kien hemm l-ebda differenzi fil-profil tas-sigurtà għal pazjenti pedjatriċi kkurati għal SCN.
English: The results of flow cytometric analysis of CD34
Maltese: Ir-riżultati tal-analiżi tal-fluss ċitometriku tan-numri taċ-ċelluli CD34
English: Dizziness
Maltese: Disurija
English: Dilution to a final concentration less than 0.2 MU (2 µg) per mL is not recommended at any time.
Maltese: Id-dilwizzjoni għal konċentrazzjoni finali ta' inqas minn 0.2 MU (2 µg/mL) mhijiex rakkomandata fi kwalunkwe ħin.
English: 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: • worsening of rheumatoid arthritis
Maltese: • aggravament ta' artrite rewmatojde
English: • bleeding from the lung (pulmonary haemorrhage)
Maltese: • infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun)
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: Sottosett 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: • osteoporosis (bone disease),
Maltese: • osteoporożi (marda tal-għadam),
English: The recommended starting dose of Grastofil is 0.1 MU/kg/day (1 micrograms/kg/day) with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 10
Maltese: MU/kg/jum (4 mikrogrammi/kg/jum) sakemm jintlaħaq għadd normali ta 'newtrofili jintlħaq u jista' jinżamm (ANC > 2.0 x 10
English: Capillary leak syndrome a
Maltese: Sindrome ta' tnixxija kapillari a
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: Veno-occlusive disease d
Maltese: Mard okklużiv tal-vini d
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: Għandha tingħata konsiderazzjoni għal waqfien temporanju jew tnaqqis tad-doża ta' filgrastim f'pazjenti b'newtropenija kronika severa li jiżviluppaw tromboċitopenija (għadd tal-plejtlits < 100 x 10
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 millmudullun.
English: Some cytotoxic medicinal products exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Maltese: Xi prodotti mediċinali ċitotossiċi juru tossiċitajiet partikulari għal pool ta' proġenituri ematopojetiċi u jistgħu jaffettwaw b'mod avvers il-mobilizzazzjoni tal-proġenituri.
English: • The other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Maltese: • Is-sustanzi l-oħra huma glacial acetic acid, sodium hydroxide, sorbitol (E420) polysorbate 80 u ilma għall-injezzjonijiet.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 10
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 10
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilisation
Maltese: Prekawzjonijiet speċjali f'donaturi normali li tkun qed issirilhom mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali
English: Blood alkaline phosphatase increased
Maltese: Żieda ta' alkaline phosphatase fiddemm
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Maltese: Innewtrofili prodotti b'rispons għal filgrastim juru funzjoni normali jew imtejba kif muri minn testijiet tal-funzjoni kemotattika u fagoċitika.
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 ġietx investigata formalment, m'hemm l-ebda evidenza li interazzjoni bħal din hi ta' ħsara.
English: Each syringe of 0.5 mL solution contains 30 MU (300 micrograms) of filgrastim (600 micrograms/mL).
Maltese: MU (300 mikrogramma) ta' filgrastim (600 mikrogramma/mL).
English: Risks associated with increased doses of chemotherapy 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 medicinaal products may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy medicinal products used).
Maltese: Riskji assoċjati ma' żieda fid-dożi tal-kimoterapija Għandha tintuża attenzjoni speċjali meta wieħed jikkura pazjenti b'doża għolja ta' kimoterapija minħabba ma ntweriex riżultat imtejjeb tat-tumur, u dożi intensifikati ta' prodotti mediċinali kimoterapewtiċi jistgħu jwasslu għal żieda fit-tossiċitajiet li jinkludu effetti kardijaċi, pulmonari, newroloġiċi, u dermatoloġiċi (jekk jogħġbok irreferi għall-informazzjoni dwar il-preskrizzjoni talprodotti mediċinali tal-kimoterapija speċifiċi li jintużaw).
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: It-twaqqif tat-terapija b'filgrastim normalment jirriżulta fi tnaqqis ta' 50% fin-newtrofili li jkunu jiċċirkolaw fi żmien minn jum sa jumejn, b'ritorn għal-livelli normali fi żmien minn jum sa 7 ijiem.
English: • 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: • ikollok reazzjoni allerġika li tinkludi dgħufija, il-pressjoni tad-demm titbaxxa, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa fil-wiċċ, xufftejn, ħalq, ilsien jew gerżuma (anġjoedema) u qtugħ ta' nifs (dispneja).
English: • severe pain in the bones, chest, gut or joints (sickle anaemia with cell crisis)
Maltese: • uġigħ sever fl-għadam, fis-sider, fl-imsaren jew fil-ġogi (anemija bi kriżi tas-sickle cells)
English: CLONMEL Healthcare Ltd. Telephone +353/52.61.77.777
Maltese: Tel:+ 353/52.61.77.777
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Maltese: Grastofil 48 MU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni f'siringa mimlija għal-lest filgrastim
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Maltese: Tagħtix filgrastim lill-pazjenti bi storja medika ta' sensittività eċċessiva għal filgrastim jew pegfilgrastim.
English: Anaemia e
Maltese: ANNESS I
English: Each pre-filled syringe contains 30 MU (300 μg) filgrastim in 0.5 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 30 MU (300 μg) filgrastim f'0.5 mL ta' soluzzjoni.
English: EU/1/13/877/003 1 prefilled syringe EU/1/13/877/004 5 prefilled syringes
Maltese: EU/1/13/877/003 1 siringa mimlija għal-lest EU/1/13/877/004 5 siringi mimlija għal-lest
English: Grastofil contains no preservative.
Maltese: Grastofil ma fih ebda preservattiv.
English: b a
Maltese: Uġigħ a
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: Il-pazjenti li jiżviluppaw sintomi tas-sindrome ta' tnixxija kapillari għandhom jiġu mmonitorjati mill-qrib u għandhom jirċievu kura standard għassintomi, li tista' tkun tinkludi l-ħtieġa ta' kura intensiva (ara sezzjoni 4.8).
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 10
Maltese: F'donaturi normali, doża ta' 1 MU/kg/jum (10 mikrogrammi/kg/jum) mogħtija taħt il-ġilda għal 4-5 ijiem konsekuttivi, tippermetti l-ġbir ta' ≥ 4 x 10
English: The recommended starting dose of Grastofil is 1.0 MU/kg/day (10 micrograms/kg/day).
Maltese: MU/kg/jum (10 mikrogrammi/kg/jum).
English: Type I glass pre-filled syringe with permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Maltese: Is-siringa mimlija għal-lest magħmula minn ħġieġ ta' Tip I b'labra ta' azzar li ma jsaddadx li hi mwaħħla b'mod permanenti fit-tarf u marki stampati ta' 1/40 għal gradazzjonijiet minn 0.1 mL sa 1 mL fuq il-bettija.
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe filgrastim
Maltese: Grastofil 30 MU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni f'siringa mimlija għal-lest filgrastim
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 fetal weight were observed.
Maltese: L-għoti ġol-vini ta' (80 μg/kg/jum) ta' filgrastim lill-fniek matul il-perjodu tal-organoġenesi kien tossiku għall-omm, u ġew osservati żieda fl-aborti spontanji, telf ta' wara l-impjantazzjoni, u tnaqqis fil-medja tan-numru ta' frieħ ħajjin u l-piż tal-feti.
English: Headache a
Maltese: Lewkoċitożi a
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 (TRM) u mortalità meta ngħata
English: CLINCAL PARTICULARS
Maltese: KLASSIFIKAZZJONI ĠENERALI
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 (newtropenija konġenitali severa, ċiklika, u idjopatika) jikkaġuna żieda sostnuta fl-ANCs fid-demm periferali u tnaqqis fl-infezzjoni u avvenimenti relatati.
English: Solution for injection/infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni/infużjoni.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Maltese: • sensazzjoni mnaqqsa ta' sensittività, speċjalment fil-ġilda (ipoestesija)
English: The recommended dose of Grastofil is 0.5 MU/kg/day (5 micrograms/kg/day).
Maltese: MU/kg/jum (5 mikrogrammi/kg/jum).
English: Muscle spasms Osteoporosis
Maltese: Kimoterapija ċitotossika stabbilita
English: EU/1/13/877/001 1 prefilled syringe EU/1/13/877/002 5 prefilled syringes
Maltese: EU/1/13/877/001 1siringa mimlija għal-lest EU/1/13/877/002 5 siringi mimlija għal-lest
English: > 5.0 x 10
Maltese: 9/L għal > 5.0 x 10
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Maltese: MDS u lewkimji huma kumplikazzjonijiet naturali tal-marda u għandhom relazzjoni inċerta mat-terapija b'filgrastim.
English: Pseudogout a
Maltese: Psewdogotta a
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomised studies, 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: Metaanaliżi ta' studji fuq trapjanti alloġeneiċi, li tinkludi r-riżultati ta' disa' studji prospettivi li fihom il-pazjenti ntgħażlu b'mod każwali, 8 studji retrospettivi u studju 1 ikkontrollat mill-każ, ma sabet l-ebda effett fuq ir-riskji ta' GvHD akuta, GvHD kronika jew mortalità relatata mal-kura bikrija.
English: A diluted solution of Grastofil for infusion should be used within 24 hours when stored at 2 °C to 8 °C.
Maltese: Soluzzjoni dilwita ta' Grastofil għall-infużjoni għandha tintuża fi żmien 24 siegħa meta tinħażen f'temperatura ta' 2 °C sa 8 °C.
English: If leukocyte counts exceed 50 x 10
Maltese: Jekk l-għadd tal-lewkoċiti jaqbeż 50 x 10
English: International Retrospective Study (2006)
Maltese: Retrospettiv Internazzjonali
English: Haemoglobin decreased e
Maltese: Tnaqqis flemoglobina e
English: Constipation e
Maltese: Astenja a
English: cells/kg recipient bodyweight.
Maltese: ċellula/kg tal-piż tal-ġisem tar reċipjent.
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Maltese: F'pazjenti li jkun qed isirilhom trapjant ta' ċelluli staminali jew trapjant tal-mudullun, mard tattrapjant kontra l-ospitu (GvHD) jista' jseħħ-din hi reazzjoni taċ-ċelluli tad-donatur kontra l-pazjent li jkun qed jirċievi t-trapjant; sinjali u sintomi jinkludu raxx fuq il-pali ta' idejk jew il-qiegħ ta' saqajk u ulċeri u feriti f'ħalqek, fl-imsaren, fil-fwied, fuq il-ġilda, jew f'għajnejk, fil-pulmun, fil-vaġina u filġogi.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults, children and adolescents receiving cytotoxic chemotherapy suggesting no agerelated differences in the pharmacokinetics of filgrastim.
Maltese: Dejta minn studji kliniċi b'filgrastim f'pazjenti pedjatriċi, tindika li s-sigurtà u l-effikaċja ta' filgrastim huma simili kemm fl-adulti kif ukoll fit-tfal u l-adolexxenti li jkunu qed jirċievu kimoterapija ċitotossika, li tissuġġerixxi li m'hemm l-ebda differenzi relatati mal-età fil-farmakokinetika ta' filgrastim.
English: Grastofil pre-filled syringe contains dry natural rubber The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.
Maltese: Grastofil siringa mimlija għal-lest fih lastku naturali niexef L-għatu tal-labra tas-siringa mimlija għal-lest fih lastku naturali xott (derivattiv tal-latex) li jista' jikkawża reazzjoni allerġika.
English: Grastofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Grastofil 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: Special precautions in patients undergoing PBPC mobilisation
Maltese: Prekawzjonijiet speċjali f'pazjenti li jkunu qed jirċievu mobilizzazzjoni tal-PBPC
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim 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: Il-mobilizzazzjoni tal-PBPC għandha tiġi kkunsidrata biss f'donaturi li jissodisfaw il-kriterji taleliġibilità normali kliniċi u tal-laboratorju għal donazzjoni ta' ċelluli staminali b'attenzjoni speċjali lill-valuri ematoloġiċi u mard infettiv.