FrancophonIA/ELRC3.0 huggingface dataset:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Maltese: Levofloxacin hu stabbli b'mod stereokimiku u ma jgħaddix minn inverżjoni kirali.
English: Serious haematological adverse reactions such as pancytopenia, agranulocytosis and haemolytic anaemia have been reported following systemic administration of levofloxacin.
Maltese: Flimkien mal-mediċina tal-istudju, il-pazjenti baqgħu fuq standard ta' kura għal infezzjoni pulmonari kronika.
English: Doses do not need to be adjusted in patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula).
Maltese: M'hemmx bżonn li d-dożi jiġu aġġustati f'pazjenti b'indeboliment ħafif sa moderat tal-kliewi (tneħħija stmata tal-kreatinina ta' ≥ 20 ml/min bl-użu tal-formula ta' Cockroft-Gault).
English: - Seizures and convulsions
Maltese: - Aċċessjonijiet u konvulżjonijiet
English: Vomiting, Abdominal pain*, Diarrhoea* Constipation*
Maltese: Uġigħ addominali*, Dijarea*,
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or on concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Maltese: Quinolones jistgħu jbaxxu l-limitu ta' aċċessjoni u jistgħu jikkawżaw aċċessjonijiet (ara sezzjoni 4.8). Levofloxacin hu kontraindikat f'pazjenti bi storja medika ta' epilessija (ara sezzjoni 4.3) u, bħal quinolones oħrajn, għandu jintuża b'kawtela estrema f'pazjenti predisposti għal aċċessjonijiet jew li jkunu qed jieħdu kura fl-istess ħin b'sustanzi attivi li jbaxxu l-limitu ta' aċċessjoni ċerebrali, bħal theophylline (ara sezzjoni 4.5).
English: Due to possible increases in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these active substances are given concomitantly (see section 4.5).
Maltese: Minħabba ż-żidiet possibbli fit-testijiet tal-koagulazzjoni (PT/INR) u/jew fil-ħruġ ta' demm f'pazjenti kkurati b'levofloxacin flimkien ma' antagonist ta' vitamina K (eż. warfarin), it-testijiet talkoagulazzjoni għandhom jiġu mmonitorjati meta dawn is-sustanzi attivi jingħataw fl-istess ħin (ara sezzjoni 4.5).
English: NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution Levofloxacin
Maltese: Quinsair 240 mg soluzzjoni għan-nebulizzatur Levofloxacin
English: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Maltese: Studji epidemjoloġiċi jirrappurtaw riskju miżjud ta' anewriżma aortika u dissezzjoni wara t-teħid ta' fluoroquinolones, b'mod partikolari fil-popolazzjoni anzjana.
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Quinsair therapy.
Maltese: Infjammazzjoni u tiċrit tat-tendins jistgħu jseħħu fl-ewwel 48 siegħa tat-trattament u saħansitra sa diversi xhur wara li titwaqqaf itterapija ta' Quinsair.
English: Treatment of these patients with levofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Maltese: It-trattament ta' dawn ilpazjenti b'levofloxacin għandu jinbeda biss fin-nuqqas ta' għażliet ta' trattament alternattiv u wara valutazzjoni bir-reqqa tal-benefiċċju u riskju (ara wkoll sezzjoni 4.3).
English: • Concomitant use of active substances that are known to prolong the QT interval (e.g. Class IA
Maltese: • L-użu fl-istess ħin ta' sustanzi attivi li huma magħrufa li jtawlu l-intervall tal-QT (eż. mediċini antiarritimiċi ta' Klassi
English: • History of tendon disorders related to fluoroquinolone administration.
Maltese: • Storja medika ta' disturbi fit-tendins muskolari assoċjati mal-għoti ta' fluoroquinolone.
English: ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6) - if you have ever had a problem with your tendons (inflammation of a tendon or a ruptured tendon) during treatment with a quinolone or fluoroquinolone antibiotic - if you suffer from epilepsy - if you are pregnant or breast-feeding
Maltese: (elenkati fis-sezzjoni 6) - jekk qatt kellek problema fit-tendins (infjammazzjoni ta' tendin jew tendin imċarrat) matul l kura b'antibijotiku li fih quinolone jew fluoroquinolone - jekk tbati mill-epilessija - jekk inti tqila jew qed tredda'
English: If acute symptomatic bronchospasm occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator at least 15 minutes to 4 hours prior to subsequent doses (see sections 4.4 and 4.8).
Maltese: Jekk iseħħ bronkospażmu sintomatiku akut wara li jirċievu Quinsair, il-pazjenti jistgħu jibbenefikaw mill-użu ta' bronkodilatur li jinġibed man-nifs li jaħdem għal ħin qasir mill-inqas 15-il minuta sa 4 sigħat qabel dożi sussegwenti (ara sezzjonijiet 4.4 u 4.8).
English: Important information to know before you start - Each ampoule is for single use only.
Maltese: Informazzjoni importanti li għandek tkun taf qabel ma tibda - Kull ampulla hi biex tintuża darba biss.
English: Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses.
Maltese: Studji fuq il-ġrieden urew li levofloxacin għandu attività fototossika f'dożi għoljin ħafna biss.
English: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
Maltese: Skonnettja l-kontrollur u żarma s-Sett tal-Idejn tan-Nebulizzatur Zirela biex tnaddfu u tiddiżinfettah.
English: Patients predisposed to seizures
Maltese: Twissijiet u prekawzjonijiet
English: 8) Once treatment is complete, disconnect the controller and take apart the Zirela Nebuliser Handset for cleaning and disinfecting.
Maltese: 8) Ġaladarba l-kura tkun lesta, skonnettja l-kontrollur u żarma s-Sett tal-Idejn tan-Nebulizzatur Zirela biex tnaddfu u tiddiżinfettah.
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered.
Maltese: Mal-ewwel sinjal ta' tendinite (eż. nefħa bl-uġigħ, infjammazzjoni) it-trattament b'levofloxacin għandu jitwaqqaf u għandu jiġi kkunsidrat trattament alternattiv.
English: Holding the handset level, press and hold the on/off button on the controller for a few seconds.
Maltese: Jekk għal xi raġuni tkun trid twaqqaf il-kura qabel ma tkun lesta, agħfas u żomm il-buttuna on/off tal-kontrollur għal sekonda waħda.
English: P = 0.012 c
Maltese: 012 ċ
English: The controller will ‘beep' once and the status light will turn green. After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Maltese: Wara ftit sekondi, ċpar tal-aerosol se jibda jnixxi ġolkompartiment tal-aerosol tal-Sett tal-Idejn tan-Nebulizzatur Zirela.
English: No specific antidote exists.
Maltese: Ma jeżisti l-ebda antidot speċifiku.
English: Prolonged, disabling and potentially irreversible serious adverse drug reactions
Maltese: Reazzjonijiet avversi serji tal-mediċina li jdumu fit-tul, li jinkapaċitaw u potenzjalment irriversibbli
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Maltese: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) huwa magħmul minn Escherichia coli K802 b' teknoloġija rikombinanti-DNA.
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Filgrastim ratiopharm.
Maltese: Fi studji kliniċi, 541 pazjenti b'kanċer u 188 volontiera f'saħħithom ġew esposti għal Filgrastim ratiopharm.
English: - The active substance is filgrastim.
Maltese: - Is-sustanza attiva hija filgrastim.
English: Filgrastim ratiopharm contains sorbitol.
Maltese: Filgrastim ratiopharm fih sorbitol.
English: > 1.0 x 109/l for 3 consecutive days
Maltese: > 1.0 x 109/l għal 3 ijiem konsekuttivi
English: Filgrastim ratiopharm contains the active substance filgrastim.
Maltese: Filgrastim ratiopharm fih is-sostanza attiva filgrastim.
English: Excipient: Each ml of solution contains 50 mg of sorbitol.
Maltese: Kull ml ta' soluzzjoni fiha 50 mg sorbitol.
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Maltese: Is-sigurta' u l-effikaċja ta' filgrastim għadhom ma ġewx stabbiliti f' pazjenti b'Lewkimja Majelojde Akuta de novo li għandhom inqas minn 55 sena u ċitoġenetiċi normali [t(8;21), t(15;17), u inv(16)].
English: When diluted in glucose 50 mg/ml (5%) solution for infusion, Filgrastim ratiopharm is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Maltese: Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta'glucose 50 mg/ml (5%), Filgrastim ratiopharm huwa kompatibbli mal-ħġieġ u varji tipi ta' plastik, fosthom il-PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: Excipients: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Maltese: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, ilma
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow
Maltese: Riskju relattiv (95% CI) ta' GvHD u TRM wara l-kura b'G-CSF wara trapjant tal-mudullun Pubblikazzjoni Perjodu tal istudju
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 30 MIU/0.5 ml
Maltese: INFORMAZZJONI BIL-BRAILLE Filgrastim ratiopharm 30 MIU/0.5ml
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 48 MIU/0.8 ml
Maltese: INFORMAZZJONI BIL-BRAILLE Filgrastim ratiopharm 48 MIU/0.8ml
English: Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Maltese: Filgrastim ratiopharm m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: Undesirable effect
Maltese: EFFETTI
English: Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Maltese: Żjidiet ħfief għal moderati, li reġgħu lura għan-normal, u li kienu dipendenti fuq id-doża, f'lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid u gamma-glutamyltransferase (GGT), seħħu f'madwar 50%, 35%, 25%, u 10% tal-pazjenti rispettivament, bl-użu ta' filgrastim bid-dożi
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors.
Maltese: Lewkoċitosi (WBC > 50 x 109/l) ġie osservat f'41% tad-donaturi waqt li tromboċitopenja reversibbli (plejtlits < 100 x 109/l) ġiet osservata f'35% tad-donaturi wara amministrazzjoni ta'
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: Lewkafereżi jrid isir fil-perijodu meta l-ANC jitla' minn < 0.5 x 109/l sa > 5.0 x 109/l.
English: Alopecia, skin rash Sweet's syndrome, cutaneous vasculitis
Maltese: Alopeċja, raxx fil-ġilda Is-Sindrome ta' Sweet, vaskulite tal-ġilda
English: These symptoms could be signs of severe pulmonary side effects, like pneumonia and respiratory distress syndrome in adults, which may be fatal.
Maltese: Sintomi bħal dawn jistgħu jkunu effetti sekondarji severi, bħal pneumonja u sindromu respiratorju fl-adulti, li jista jkun fatali.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C - 8°C)
English: Filgrastim ratiopharm 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: Filgrastim ratiopharm 30 MIU/0.5ml: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 ml soluzzjoni.
English: Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Maltese: Uġigħ fis-sider, uġigħ muskoloskeletriku Aggravament ta' artrite rewmatojde
English: TRM
Maltese: Studju
English: EU/1/08/449/007 2 x 5 pre-filled syringes
Maltese: FIS-SUQ EU/1/08/449/007 2 x 5 siringi mimlija għal-lest
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Filgrastim ratiopharm 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'Filgrastim ratiopharm kien komparabbli ma' dak tal-prodott ta' referenza kemm wara amministrazzjoni taħt il-ġilda kif ukoll ġol-vina.
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: EU/1/08/449/003 2 x 5 pre-filled syringes
Maltese: FIS-SUQ EU/1/08/449/003 2 x 5 siringi mimlija għal-lest
English: - inflammation of blood vessels, often with skin rash (very rare); the appearance of plumcoloured, raised, painful lesions on the limbs (sometimes the face and neck) with fever (Sweet's syndrome, very rare); hair loss; pain at the site of injection; rash joint pain; chest pain; worsening of rheumatic conditions; loss of calcium from the bones; pain and swelling of the joints, similar to gout (frequency unknown) - fatigue, generalised weakness, unspecified pain.
Maltese: - uġigħ jew diffikulta biex tgħaddi l-awrina (rari ħafna), demm fl-awrina, protejn fl-awrina - żieda fid-daqs tal-fwied - infjammazzjoni tal-vini, ta' spiss akkompanjat b'raxx (rari ħafna); id-dehra ta' leżjonijiet ibbuzzati, li jweġgħu, kulur aħmar skur fil-vjola fuq ir-riġlejn (xi drabi fil-wiċċ u fl-ghonq) u bid-deni (is-Sindromu ta' Sweet, rari ħafna); telf ta' xagħar; uġigħ fis-sit ta' l-injezzjoni; raxx - uġigħ fl-għadam; uġigħ fis-sider; aggravament ta' kundizzjonijiet rewmatiċi; tnaqqis tal-kalċju fl-għadam; uġigħ u nefħa tal-ġogi, simili għal gotta (frekwenza mhux magħrufa) - għeja, debbulizza, uġigħ ġenerali.
English: Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Maltese: Filgrastim ratiopharm 30 MIU/0.5ml soluzzjoni għall-injezzjoni jew infużjoni Filgrastim ratiopharm 48 MIU/0.8ml soluzzjoni għall-injezzjoni jew infużjoni
English: Filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Maltese: Filgrastim ratiopharm huwa indikat għal kura ta' newtropenja persistenti (ANC ta' 1.0 x 109/l jew inqas) f'pazjenti b'infezzjoni avvanzata ta' l-HIV, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi, dan meta għażliet oħra għall-immaniġġjar ta' newtropenja ma jkunux addattati.
English: - neutropenia in patients with HIV infection, - peripheral blood stem cell mobilisation.
Maltese: - newtropenja f'pazjenti li huma infettati bl-HIV, - mobilizzazzjoni taċ'ċelluli proġenitriċi tad-demm periferali.
English: In patients with severe chronic neutropenia (SCN)
Maltese: F'pazjenti b'newtropenja kronika u qawwija (SCN)
English: Alopecia, cutaneous vasculitis, injection site pain, rash Musculoskeletal pain Osteoporosis
Maltese: Alopeċja, infjammazzjoni vaskulari fil-ġilda, injezzjoni site uġigħ fis-sit ta' injezzjoni, raxx
English: How do I inject Filgrastim ratiopharm myself?
Maltese: Kif nipprepara l-injezzjoni ta' Filgrastim ratiopharm?
English: Filgrastim ratiopharm are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Maltese: Filgrastim ratiopharm jiġi f'pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest jew f'pakkett multiplu ta'10 (2 pakketti ta' 5).
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/mm3.
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: less than 1 user in 10,000
Maltese: talanqas 1 minn kull 10 pazjent f'10,000
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 ta' l-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' 200mg/ml (20%) albumina umana
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: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallfructose m'għandhomx jieħdu din il-mediċina.
English: Rheumatoid arthritis exacerbation Severe allergic reaction
Maltese: Uġigħ muskolu-skeltrali Aggravament ta' l-artrite rewmatika
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline were 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 instabu li kellhom abnormalitajiet, fosthom monosomy 7, f'analiżi li ġew ripetuti perjodikament.
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
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: Filgrastim ratiopharm 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: Filgrastim ratiopharm 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: 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: 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 fiż-żmien 1 sa 7 ijiem.
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' produzzjoni minima ta' 2.0 x 106 CD34+ ċelluli/kg hija bbażata fuq tagħrif ta'esperjenzi ppublikati li irriżultaw f'rikostituzzjoni ematoloġika adegwata.
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: What Filgrastim ratiopharm is used for
Maltese: Filgrastim ratiopharm
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: In view of the possible risk of microbial contamination, Filgrastim ratiopharm syringes are for single use only.
Maltese: Minħabba r-riskju potenzjali ta' kontaminazzjoni bil-mikrobi, is-siringi ta' Filgrastim ratiopharm iridu jintużaw darba biss.
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: QUALITATIVE AND QUANTITATIVE COMPOSITION 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: - Keep this leaflet.
Maltese: Ftit każijiet ta' milza
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
Maltese: L-MAH huwa obbligat li jwettaq l-istudji u attivitajiet ta' farmakoviġilanza addizzjonali deskritti fil-pjan tal-Farmakoviġilanza, kif maqbul fil-verżjoni 5 tal-Pjan dwar l-Immaniġġjar tar-Riskju (RMP) ippreżentat f'Modulu 1.8.2. ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq, u kwalunkwe aġġornamenti sussegwenti tal-RMP li kienu maqbula mis-CHMP.
English: White blood cell counts of 100 x 109/l or greater have been observed in less than 5% of patients 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: Filgrastim ratiopharm 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: Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
Maltese: L-esposizzjoni bi żball għal temperatura ta' friża ma jeffettwax ħażin l-istabilita` ta' Filgrastim ratiopharm.
English: Leukocytosis, thrombocytopenia
Maltese: Kimoterapija ċitotossika stabbilita