FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini
English: Risk associated with increased doses of myelosuppressive medicinal products
Maltese: Riskju assoċjat ma' dożi miżjuda ta' prodotti mediċinali majelosoppressivi
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: Aġenti bħal melphalan, carmustine (BCNU) u carboplatin, meta jiġu amministrati għal perijodi twal qabel tentattivi ta' mobilizzazzjoni taċ-ċelluli proġenitriċi, jistgħu jirriżultaw f'numru inqas ta' ċelluli proġenitriċi.
English: EU/1/08/450/005 EU/1/08/450/006 EU/1/08/450/007 EU/1/08/450/008 EU/1/08/450/010
Maltese: EU/1/08/450/007 EU/1/08/450/008 EU/1/08/450/010
English: Rheumatoid arthritis exacerbation
Maltese: Aggravament tal-artrite rewmatika
English: How do I prepare my Biograstim injection?
Maltese: Kif nipprepara l-injezzjoni ta' Biograstim?
English: Contents of the pack and other information Information for injecting yourself
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to < 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of G-CSFs; see section 4.4 and subsection “Description of selected adverse reactions” of section 4.8.
Maltese: Sindromu ta' tnixxija tal-kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament huwa tardjat, ġie irrapportat b'mod mhux komuni (≥ 1/1000 sa < 1/100) f'pazjenti b' kanċer waqt il-kimoterapija u f'donaturi normali li kien qed ikollhom mobilizzazzjoni taċ-ċelluli proġenituri tad-demm periferali wara l-għoti ta' G-CSFs; ara sezzjoni 4.4 u subsezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” tat-taqsima 4.8.
English: Severe allergic reaction *See subsection “Description of selected adverse reactions” of section 4.8
Maltese: Reazzjoni allerġiku *Ara subsezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” tat-taqsima 4.8
English: Very rare: Not known:
Maltese: Rari ħafna:
English: Biograstim is a biosimilar medicinal product.
Maltese: Biograstim hu prodott mediċinali bijoloġiku simili.
English: Biograstim and chemotherapy
Maltese: Biograstim u kimoterapija
English: Undesirable effects reported with equal frequency in patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Maltese: Effetti mhux mixtieqa li ġew irrapporti bl-istess frekwenza f'pazjenti kkurati b'filgrastim/kimoterapija u b'placebo/kimoterapija jinkludu tqalligħ u rimettar, alopeċja, dijarreja, għeja, anoressija, mukożite, uġigħ ta' ras, sogħla, raxx fil-ġilda, uġigħ fis-sider, debbulizza, uġigħ fil-grieżem, stitikezza u uġigħ ġenerali.
English: Epistaxis
Maltese: Epitassi
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Maltese: Studji randomised, single-blind, b'doża waħda u crossover li saru fuq 196 voluntiera b'saħħithom urew li l-profil farmakokinetiku ta'Biograstim kien komparabbli ma' dak tal-prodott ta' referenza kemm wara amministrazzjoni taħt il-ġilda kif ukoll ġol-vina.
English: Biograstim 48 MIU/0.8 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Biograstim 48 MIU/0.8 mL
English: Chest pain, musculoskeletal pain
Maltese: Uġigħ fis-sider, uġigħ muskoloskeletriku
English: Undesirable effects possibly related to filgrastim therapy and typically occurring in < 2 % of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis and rash.
Maltese: Effetti mhux mixtieqa possibilment relatati ma' kura ta' filgrastim, u li tipikament seħħu f'inqas minn 2% tal-pazjenti b'newtropenja qawwija u kronika, kienu rejazzjonijiet fis-sit ta' injezzjoni, uġigħ ta' ras, epatomegalija, arthralgia, alopeċja, ostejoporosi u raxx.
English: Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MIU (300 μg) should be given with 0.2 mL of 200 mg/mL (20 %) human albumin solution added.
Maltese: Meta l-volum finali tal-injezzjoni huwa 20 mL, id-dożi kollha ta' filgrastim li fihom inqas minn 30 MIU (300 μg) iridu jingħataw b'0.2 mL soluzzjoni ta' 200 mg/mL (20%) albumina umana miżjuda.
English: You will hear a “click”, which confirms activation of the safety device.
Maltese: Se tisma “klikk”, li tikkonferma l-attivazzjoni tattagħmir tas-sigurtà.
English: In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltration, dyspnoea and hypoxia) have been reported in postmarketing experience (see section 4.4).
Maltese: F'donaturi normali, avvenimenti avversi pulmonari (emoptisi, emorraġija pulmonari, infiltrazzjoni filpulmun, qtugħ ta' nifs u nuqqas ta' ossiġnu) kienu rrappurtati wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: Allergic reaction *See subsection “Description of selected adverse reactions” of section 4.8
Maltese: *Ara subsezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” tat-taqsima 4.8
English: In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
Maltese: Fi studji kliniċi, 97% tal-pazjenti li rrispondu kellhom rispons komplet b'doża ta' ≤ 2.4
English: SGOT increased, hyperuricaemia
Maltese: Żjieda fl-SGOT, iperurikemija
English: (230 μg)/m
Maltese: MIU (2 μg)/mL.
English: Biograstim 30 MIU/0.5 mL solution for injection or infusion Biograstim 48 MIU/0.8 mL solution for injection or infusion
Maltese: Biograstim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Biograstim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni jew infużjoni
English: Alopecia, cutaneous vasculitis, injection site pain, rash
Maltese: Alopeċja, infjammazzjoni vaskulari fil-ġilda, injezzjoni site uġigħ fis-sit ta' injezzjoni, raxx
English: In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, dyspnoea and hypoxia) have been reported very rarely in postmarketing experience.
Maltese: F'donaturi normali, avvenimenti avversi pulmonari (emoptisi, emorraġija pulmonari, infiltrazzjoni filpulmun, qtugħ ta' nifs u nuqqas ta' ossiġnu) kienu rrappurtati b'mod rari ħafna wara t-tqegħid fis-suq.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Maltese: Prekawzjonijiet speċjali f'reċipjenti ta' trapjant alloġenejiku ta' PBPC mobilizzati b'filgrastim
English: Neutrophil count
Maltese: Newtropenja konġenitali
English: However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 10
Maltese: Madankollu, waqt il-perijodu tal-amministrazzjoni ta' filgrastim għall-mobilizzazzjoni ta' PBPC, kura b'filgrastim trid jitwaqqaf jew id-doża titniżżel jekk l-għadd ta' lewkoċiti titla' għal > 70 x 109/L.
English: Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Maltese: Tnaqqis fil-glucose, żjieda fl-alkaline phosphatase, żjieda fil-LDH, iperurikemija
English: Biograstim and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Maltese: Biograstim u newtropenja f'pazjenti bl-infezzjoni ta' HIV Id-doża tal-bidu li tintuża normali hija bejn 0.1 u 0.4 miljun international units (MIU) għal kull kilogramm ta' piż tal-ġisem, kuljum.
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: Subset ta' madwar 12% tal-pazjenti li fil-bidu kellhom parametri ċitoġenetiċi normali, sussegwentement instab li kellu abnormalitajiet, fosthom monosomy 7, f'analiżi li ġew ripetuti perjodikament.
English: For example, if you weigh 60 kg your daily dose will be 30 million international units (MIU).
Maltese: Per eżempju, jekk tiżen 60 kg, id-doża tiegħek ta' kuljum hi ta' 30 miljun international units (MIU).
English: Exacerbation of arthritic symptoms has been observed very rarely.
Maltese: Aggravament tas-sintomi tal-artrite kien osservat f'każijiet rari ħafna.
English: There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
Maltese: Kien hemm rapporti tal-graft kontra l-mard tal-ospitu (GvHD) u fatalitajiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeniku tal-mudullun (ara sezzjoni 5.1).
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu din il-mediċina.
English: Normal donors are given a dose of a 10 μg/kg/day, administered subcutaneously for 4 to 5 consecutive days.
Maltese: Donaturi normali jingħataw doża ta' 10 μg/kg/jum, amministrata taħt il-ġilda għal 4 sa 5 ijiem konsekuttivi.
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 fiżżmien ġurnata jew tnejn, b'ritorn għall-livelli normali fiż-żmien 1 sa 7 ijiem.
English: Date of first authorisation: 15 September 2008.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Settembru 2008
English: Biograstim 48 MIU/0.8 mL: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f'0.8 mL (60
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/mL (5 %) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
Maltese: Filgrastim jista' jiġi injettat ta' kuljum taħt il-ġilda jew jista' jiġi dilwit f'soluzzjoni ta' glucose 50 mg/mL (5%) u jingħata ta' kuljum bħala infużjoni ġol-vina fuq medda ta' 30 minuta (ara sezzjoni 6.6 għall-istruzzjonijiet fuq id-dilwit).
English: The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
Maltese: Ġew irrapportati xi każijiet tas-sindromu Sweet (dermatożi akuta u bid-deni).
English: Biograstim contains sorbitol and sodium
Maltese: Biograstim fih sorbitol u sodju
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Maltese: Immunostimulanti, fatturi li jistimolaw il-kolonji ta' granuloċiti, Kodiċi ATC:
English: Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in normal donors receiving filgrastim; these were without clinical sequelae.
Maltese: Żjidiet ħfief, li reġgħu lura għan-normal, fl-alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) u uric acid kienu rrapportati f'donaturi b'saħħithom li rċievu filgrastim; dawn ma kellhomx effetti kliniċi assoċjati magħhom.
English: Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase and alkaline phosphatase.
Maltese: Ġew osservati żjidiet, li jerġgħu lura għan-normal, u mingħajr effetti kliniċi assoċjati, fil-uric acid, lactic dehydrogenase u alkaline phosphatase.
English: Biograstim is useful in several different conditions, which are: - chemotherapy; - bone marrow transplantation; - severe chronic neutropenia (low white blood cell count); - neutropenia in patients with HIV infection; - peripheral blood stem cell mobilisation (for blood stem cell donation).
Maltese: Biograstim huwa ta' benefiċju f'ħafna kundizzjonijiet differenti li huma: - kimoterapija, - trapjant tal-mudullun, - newtropenja qawwija u kronika (għadd baxx ta' ċelluli bojod tad-demm), - newtropenja f'pazjenti li huma infettati bl-HIV, - mobilizzazzjoni taċ'ċelluli proġenitriċi tad-demm periferali (għad-donazzjoni taċ-ċelluli staminali tad-demm).
English: In cancer patients, the pharmacokinetic profile of Biograstim and the reference product was comparable after single and repeated subcutaneous administration.
Maltese: F'pazjenti b'kanċer, il-profil farmacokinetiku ta' Biograstim u dak tal-prodott ta' referenza kienu komparabbli wara amministrazzjoni taħt il-ġilda ta' doża waħda jew dożi ripetuti.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Maltese: Il-G-CSF uman huwa glikoproteina li tirregola l-produzzjoni u l-ħelsien ta' newtrofili mill-mudullun.
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm
Maltese: Trid tiġi kkunsidrata il-waqfien intermittenti ta' kura jew it-tnaqqis fid-doża ta' filgrastim f'pazjenti li jiżvillupaw tromboċitopenja, i.e. l-għadd tal-plejtlits jkun konsistentement < 100,000/mm3.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Maltese: Fejn pazjenti jirċievu soluzzjoni ta' filgrastim dilwit sa konċentrzzjoni inqas minn 15 MIU (15 μg)/mL, għandha tiġi miżjuda bl-albumina umana (HSA) sabiex il-konċentrazzjoni finali tkun 2 mg/mL.
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
Maltese: Kien hemm rapporti ta' GvHD u fatalitajiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeniku tal-mudullun (ara sezzjoni 5.1).
English: Nausea/Vomiting Constipation, anorexia, diarrhoea, mucositis
Maltese: Stitikezza, anoressija, dijarreja, mukożite
English: Elevated alkaline phosphatase, elevated LDH, elevated uric acid
Maltese: Żjieda fl-alkaline phosphatase, zjieda fil-LDH, żjieda fil-uric acid
English: Biograstim 48 MIU/0.8 mL solution for injection or infusion Filgrastim
Maltese: Biograstim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni jew infużjoni 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 frewkwenza baxxa (madwar 3%) ta' sindromi majelodisplastiċi (MDS) jew lewkimja f'pazjenti b'SCN ikkurati b'filgrastim.
English: Each mL of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni għall-injezzjoni jew infużjoni fiha 60 miljun international units [MIU] (600 µg) ta' filgrastim.
English: Leukocytosis, thrombocytopenia Spleen disorder
Maltese: Lewkoċitosi, tromboċitopenja
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2C - 8C)
English: Anaemia and epistaxis have also been reported.
Maltese: Anemija and epistassi wkoll ġew irrapportati.
English: Headaches, believed to be caused by filgrastim, have been reported in PBPC donor studies.
Maltese: Uġigħ ta' ras, maħsub li ġej minħabba l-filgrastim, ġie rapportat f'studji fuq donaturi ta' PBPC.
English: Alopecia, skin rash Sweet's syndrome, cutaneous vasculitis
Maltese: Alopeċja, raxx fil-ġilda taħt il-ġilda
English: Elevated alkaline phosphatase, elevated LDH
Maltese: Żjieda fl-alkaline phosphatase, żjieda fil-LDH
English: Biograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 mL soluzzjoni.
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 Adult Respiratory Distress Syndrome (ARDS).
Maltese: 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 tal-bidu tas-sindromu tat-tbatija respiratorja fl-adulti (ARDS).
English: Urinary abnormalities
Maltese: Abnormalitajiet fis-sistema urinarja
English: Solution for injection or infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni jew infużjoni Pakkett multiplu: 10 (2 pakketti ta' 5) siringi mimlija għal-lest b'0.8 mL.
English: Cough, sore throat Pulmonary infiltrates
Maltese: Infiltrati pulmonari
English: Uncommon (may affect up to 1 in 100 people): - elevated levels of some liver enzymes; high blood levels of uric acid; - worsening of rheumatic conditions.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): - żjidiet fil-livelli ta' xi enżimi tal-fwied; livelli għolja ta' uric acid fid-demm; - aggravament ta' kundizzjonijiet rewmatiċi.
English: 4.8 Undesirable effects Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurtà
English: In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Maltese: Minħabba r-riskju potenzjali ta' kontaminazzjoni bil-mikrobi, is-siringi ta' Biograstim iridu jintużaw darba biss.
English: - if you have osteoporosis.
Maltese: - jekk għandek l-osteoporożi.
English: EU/1/08/450/001 1 pre-filled syringe EU/1/08/450/002 5 pre-filled syringes EU/1/08/450/004 10 pre-filled syringes EU/1/08/450/009 5 pre-filled syringes with safety device
Maltese: EU/1/08/450/001 1 siringa mimlija għal-lest EU/1/08/450/002 5 siringi mimlija għal-lest EU/1/08/450/004 10 siringi mimlija għal-lest EU/1/08/450/009 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs tal-milza għandu jiġi monitorjat b'attenzjoni (eż. b'eżaminazzjoni klinika, b'eżami ultrasoniku).
English: Musculoskeletal pain
Maltese: Uġigħ muskolu-skeltrali
English: EU/1/08/450/005 1 pre-filled syringe EU/1/08/450/006 5 pre-filled syringes EU/1/08/450/008 10 pre-filled syringes EU/1/08/450/010 5 pre-filled syringes with safety device
Maltese: EU/1/08/450/005 1 siringa mimlija għal-lest EU/1/08/450/006 5 siringi mimlija għal-lest EU/1/08/450/008 10 siringi mimlija għal-lest EU/1/08/450/010 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra
English: Solution for injection or infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni jew infużjoni Pakkett multiplu: 10 (2 pakketti ta' 5) siringi mimlija għal-lest b'0.5 mL.
English: For infusions, filgrastim should be diluted in 20 mL of glucose 50 mg/mL (5 %) solution for infusion (see section 6.6 for instructions on dilution).
Maltese: Għall-infużjoni, id-doża ta' filgrastim trid tkun miżjuda ma' 20 mL soluzzjoni ta' glucose 50 mg/mL (5%) (ara sezzjoni 6.6 għall-istruzzjonijiet fuq id-dilwit).
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'lewkimji majeloġeni akuti u kroniċi, ma ġie osservat l-ebda effett fuq ir-riskju ta' GvHD, TRM u l-mortalità.
English: Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Maltese: Effetti mhux mixtieqa rari tal-pulmun, fosthom pulmonite interstizjali, edema pulmonari, ġew irrapportati fejn ftit minnhom irriżultaw f'inkapaċità respiratorja jew sindromu tat-tbatija respiratorja fl-adulti (ARDS), li setgħu jkunu fatali (ara sezzjoni 4.4)
English: 1 pre-filled syringe containing 0.8 mL 5 pre-filled syringes containing 0.8 mL 5 pre-filled syringes with safety device containing 0.8 mL 10 pre-filled syringes containing 0.8 mL
Maltese: 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra b'0.8 mL 10 siringi mimlija għal-lest b'0.8 mL
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Maltese: Is-sigurta' u l-effikaċja ta' filgrastim ma ġewx investigati f'donaturi b'saħħithom < 16-il sena jew > 60 sena.
English: Biograstim 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: Biograstim hu indikat għat-tnaqqis fid-dewmien ta' newtropenja u fl-inċidenza ta' newtropenja biddeni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita kontra malinni (bl-eċċezzjoni ta' lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti, taħt kura majeloablativa u segwita bit-trapjant tal-mudullun, li huma meqjusa li għandhom riskju għola ta' newtropenja qawwija u mdewma.
English: 9/L or greater have been observed in less than 5 % of patients White blood cell counts of 100 x 10 receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Maltese: Għadd taċ-ċelluli bojod ta' 100 x 109/L jew aktar ġew osservati f'inqas minn 5% tal-pazjenti li ngħataw filgrastim b'dożi akbar minn 0.3 MIU/kg/jum (3 μg/kg/jum).
English: The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Maltese: III, randomised u kontrollati bi placebo, f'pazjenti b'kanċer tas-sider, kanċer tal-pulmun u Non-Hodgkin-Limfoma.
English: Exacerbation of rheumatoid arthritis has been observed in individual cases.
Maltese: Aggravament ta' artrite rewmatika kien osservat f'każijiet individwali.
English: The recommended dose is...
Maltese: Id-doża rakkomandata hija…
English: This medicine is given by injection, either through an intravenous (IV) infusion (drip) or a subcutaneous (SC) injection (into the tissue just under the skin).
Maltese: Din il-mediċina tingħata permezz ta' injezzjoni, jew b'infużjoni ġol-vina (drip) (IV) jew b'injezzjoni taħt il-ġilda (SC) (fit-tessuti eżatt taħt il-ġilda).
English: Allergic Reactions: Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment, have been reported in patients receiving filgrastim.
Maltese: Reazzjonijiet ta' allerġija, inklużi anafilassi, raxx tal-ġilda, urtikarja, anġjoedema, qtugħ ta' nifs u pressjoni baxxa, li seħħew mal-bidu jew wara l-kura, ġew irrapportati f'pazjenti li qed jirċievu l-filgrastim.