FrancophonIA/ELRC3.0 huggingface dataset:
English: The optimal duration of treatment has not been formally established.
Maltese: L-aħjar tul ta' kura ma ġiex stabbilit formalment.
English: fluconazole or voriconazole, medicines to treat fungal infections, anti-retroviral medicines (medicines to treat HIV infections) carbamazepine, a medicine to treat some forms of epilepsy, moclobemide, medicine to treat depression, repaglinide, medicine to treat diabetes, paclitaxel, medicine to treat cancer.
Maltese: o inibitur selettiv tal-ġbir mill-ġdid ta' serotonin (li jinkludi iżda mhux limitat għal fluoxetine jew fluvoxamine), mediċini li ssoltu jintużaw fil-kura tad-dipressjoni, omeprazole jew esomeprazole, mediċini għat-taqlib tal-istonku fluconazole jew voriconazole, mediċini li jittrattaw infezzjonijiet tal-fungu, mediċini antiretrovirali (mediċini għall-kura ta' infezzjonijiet bl-HIV), carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija, moclobemide, mediċina għat-trattament tad-dipressjoni repaglinide, mediċina għat-trattament tad-dijabete, paclitaxel, mediċina għat-trattament tal-kanċer.
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, lużu konkomitanti inibituri qawwijin jew moderati ta' CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: 7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
Maltese: EU/1/09/559/013 28 pillola miksija b'rita - folja kalendarja:
English: Clopidogrel Mylan contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Id-Dehra ta' Clopidogrel Mylan u l-kontenuti tal-pakkett:
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi tal-intenzjoni tal-kura, ġew osservati 939 każ fil-grupp ta' clopidogrel u 1,020 każ ma' ASA (tnaqqis tar-riskju relattiv, relative risk reduction (RRR)) 8.7 %, [95 % CI: 0.2 sa 16.4]; p = 0.
English: 30 film-coated tablets: EU/1/09/559/004
Maltese: EU/1/09/559/004
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti miġbura skont linja bażi ta' karatteristiċi u t-tip ta' terapija fibrinolitika jew bil-heparin.
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Maltese: Dejta minn prova kliniċi tappoġġja l-użu għal sa 12-il xahar, u l-benefiċċju massimu ġie osservat fi żmien 3 xhur (ara sezzjoni 5.1).
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital, or oestrogen.
Maltese: Barra minn hekk, l-attività farmakodinamika ta' clopidogrel ma ġietx influwenzata b'mod sinifikanti mit-teħid konġunt ma' phenobarbital, jew oestrogen.
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75 - 100 mg daily) should be initiated and continued in combination with clopidogrel (see section
Maltese: F'pazjenti b'fibrillazzjoni atrijali, clopidogrel għandu jingħata bħala doża waħda kuljum ta' 75 mg. ASA (75-100 mg kuljum) għandu jinbeda u jitkompla flimkien ma' clopidogrel (ara sezzjoni 5.1).
English: Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Maltese: Għalhekk, lil hemm minn 3 xhur ta' kura, il-benefiċċju osservat fil-grupp ta' clopidogrel + ASA ma żdiedx aktar, filwaqt li r-riskju ta' emorraġija ppersista (ara sezzjoni 4.4).
English: • Bioequivalence vis-à-vis a valid EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Maltese: • Il-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE ntweriet, abbażi ta' data rilevanti, skont ir-rekwiżiti tal-Artikolu 10 tad-Direttiva 2001/83/KE (eż. studju ta' bijoekwivalenza mwettaq fir-rigward tal-prodott mediċinali ta' referenza tal-UE).
English: For the suspension of the marketing authorisations to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holders
Maltese: Sabiex titneħħa s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq, l-awtoritajiet kompetenti talIstati Membri tal-UE għandhom jiżguraw li l-kondizzjoni ta' hawn taħt ġiet issodisfata mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq
English: - The active substance is filgrastim.
Maltese: - Is-sustanza attiva hi filgrastim.
English: 08409 Vilnius Lithuania
Maltese: 08409 Vilnius Il-Litwanja
English: Uncommon to < 1/100)
Maltese: Mhux komuni sa < 1/100)
English: (Chondrocal cinosis Pyrophosph ate)
Maltese: (Chondroca lcinosis Pyrophosph ate)
English: Meta-analysis
Maltese: Meta-analiżi
English: Ratiograstim contains sorbitol (E420).
Maltese: Ratiograstim fih sorbitol (E420).
English: Sweets syndrome
Maltese: Sindrome ta' Sweets
English: Name and address of the manufacturer of the biological active substance SICOR Biotech UAB
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva SICOR Biotech UAB
English: Alopeciaa
Maltese: Alopeċjaa
English: MedDRA system organ class
Maltese: Klassi tassistemi u tal-organi MedDRA
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2°C - 8°C)
English: ANC = absolute neutrophil count
Maltese: ANC = għadd assolut ta' newtrofili (absolute neutrophil count)
English: Proteinuria Glomerulon ephritis
Maltese: Proteinurja Glomerulon efrite
English: Date of latest renewal: 19 July 2013.
Maltese: Data tal-aħħar tiġdid: 19 ta' Lulju 2013.
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Ratiograstim 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%), Ratiograstim huwa kompatibbli mal-ħġieġ u varji tipi ta' plastik, fosthom il-PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
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-sigurtà u l-effikaċja tal-għoti ta' filgrastim għadhom ma ġewx stabbiliti f'pazjenti b'AML de novo li għandhom < 55 sena u ċitoġenetiċi tajbin (t(8;21), t(15;17), u inv(16)).
English: > 1.0 x 109/L for 3 consecutive days
Maltese: > 1.0 x 109/L għal 3 ijiem konsekuttivi
English: This medicine contains 50 mg sorbitol in each mL.
Maltese: Kull mL ta' soluzzjoni fiha 50 mg sorbitol.
English: • abnormal x-rays of the lungs (lung infiltration)
Maltese: • x-rays tal-pulmun mhux normali (infiltrazzjoni tal-pulmun)
English: Ratiograstim contains sodium
Maltese: Ratiograstim fih sodium
English: Ratiograstim contains sorbitol
Maltese: Ratiograstim fih sorbitol
English: Diarrhoeaa, e Vomitinga,e Nauseaa
Maltese: Dijareaa, e Rimettara, e Dardira
English: Ratiograstim should not be diluted with sodium chloride solution.
Maltese: Ratiograstim m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4).
Maltese: Lewkoċitosi (WBC > 50 x 109/L) ġiet osservata f'41 % tad-donaturi normali waqt li tromboċitopenija temporanja (plejtlits < 100 x 109/L) ġiet osservata f'35% tad-donaturi wara filgrastim u lewkafereżi
English: Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Maltese: Ratiograstim huwa indikat għall-mobilizzazzjoni taċ-ċelluli proġenitriċi tad-demm periferali(PBPC).
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 normali ta' < 16-il sena jew > 60 sena.
English: In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
Maltese: Fi studji kliniċi randomised, intużat doża ta' 23 MIU (230 μg)/m2/jum (4.0 sa 8.4 μg/kg/jum) li ġiet amministrata taħt il-ġilda.
English: Fatigue a
Maltese: Lewkoċitosi a
English: Thrombocyt openia Anaemiae
Maltese: Tromboċito penija Anemijae
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/L.
Maltese: jinżamm (ANC > 2.0 x 109/L).
English: 30 months.
Maltese: 6 xhur.
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Maltese: Sindrome ta' Sweets (dermatosi newtrofilika akuta biddeni)
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Maltese: Anormalitajiet ċitoġeniċi temporanji ġew osservati f'donaturi normali wara l-użu ta' G-CSF.
English: • bumpy skin rash (rash macuo-papular)
Maltese: • raxx bil-ponot tal-ġilda (raxx makulopapulari)
English: Filgrastim should be diluted in 20 mL of 5% glucose solution for infusion (see section 6.6).
Maltese: soluzzjoni għall-infużjoni ta' 5% glucose (ara sezzjoni 6.6).
English: Musculoskeletal painc
Maltese: Uġigħ muskoluskeletrikuc
English: Lung infiltrationa
Maltese: Infiltrazzjon i filpulmuna
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: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Maltese: Sustanzi bħal melphalan, carmustine (BCNU) u carboplatin, meta jingħataw għal perijodi twal qabel tentattivi ta' mobilizzazzjoni taċ-ċelluli proġenituri, jistgħu jirriżultaw f'numru inqas ta' ċelluli proġenituri.
English: Ratiograstim 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: Ratiograstim 30 MIU/0.5 mL: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 mL soluzzjoni.
English: EU/1/08/444/007 2 x 5 pre-filled syringes
Maltese: EU/1/08/444/007 2 x 5 siringi mimlija għal-lest
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 4.8 and 5.1).
Maltese: Kien hemm rapporti ta' marda tat-trapjant kontra l-ospitu (GvHD - graft versus host disease) u fatalitajiet f'pazjenti li jirċievu G-CSF wara trapjant tal-mudullun alloġeniku (ara sezzjoni 4.8 u 5.1).
English: Metabolis m and nutrition disorders
Maltese: Disturbi fil metaboliżm u u nnutrizzjoni
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Maltese: Filgrastim ma affettwax il-prestazzjoni riproduttiva jew il-fertilità f'firien irġiel jew nisa (ara sezzjoni 5.3).
English: EU/1/08/444/003 2 x 5 pre-filled syringes
Maltese: EU/1/08/444/003 2 x 5 siringi mimlija għal-lest
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' produzzjonijiet minimi ta' ≥ 2.0 x 106 CD34+ ċelluli/kg hija bbażata fuq esperjenzi ppublikati li rriżultaw f'rikostituzzjoni ematoloġika adegwata.
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Ratiograstim 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'Ratiograstim kien komparabbli ma' dak tal-prodott ta' referenza kemm wara amministrazzjoni taħt il-ġilda kif ukoll ġol-vina.
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Maltese: • nefħa u/jew fluwidu fil-pulmun (edima pulmonari)
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 fil-vini ta' 30 minuta jew ta' 24 siegħa jew jista' jingħata permezz ta' infużjoni kontinwa taħt il-ġilda ta' 24 siegħa.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Maltese: Prekawzjonijiet speċjali f'reċipjenti ta' PBPCs alloġeniċi mobilizzati b'filgrastim
English: Sepsis Bronchitis Upper respiratory tract infection Urinary tract infection
Maltese: Sepsis Bronkite Infezzjoni fl-apparat respiratorju ta' fuq Infezzjoni fl-apparat tal-awrina
English: Injury, poisoning and procedural complicatio ns
Maltese: Korriment, avvelename nt u komplikazz jonijiet ta'
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Maltese: Psewdogotta (chondrocalcinosis pyrophosphate) Kienet irrappurtata psewdogotta (chondrocalcinosis pyrophosphate) f'pazjenti bil-kanċer ittrattati b'filgrastim.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution for infusion given over 30 minutes (see section 6.6).
Maltese: Metodu ta' kif għandu jingħata Filgrastim jista' jingħata bħala injezzjoni taħt il-ġilda ta' kuljum jew bħala infużjoni fil-vini ta' kuljum dilwita f'soluzzjoni għall-infużjoni ta' 5% glucose mogħtija fuq 30 minuta (ara sezzjoni 6.6).
English: b.Tabulated summary of adverse reactions
Maltese: b. Sommarju ta' reazzjonijiet avversi f'tabella
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Maltese: Ir-reazzjonijiet avversi l-aktar serji li jistgħu jseħħu waqt trattament b'filgrastim jinkludu: reazzjoni anafilattika, avvenimenti pulmonari avversi serji (inklużi pulmonite tal-interstizju u ARDS), sindrome ta' tnixxija tal-kapillari, splenomegalija severa/tiċrit tal-milsa, trasformazzjoni għal sindrome mijelodisplastiku jew lewkimja f'pazjenti b'SCN, GvHD f'pazjenti li jirċievu trasferiment alloġeniku tal-mudullun jew trapjant ta' ċelluli proġenituri tad-demm periferali u każijiet ta' kriżi taċ-ċelluli sickle f'pazjenti bil-marda taċ-ċelluli sickle.
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 (madwar 3 %) ta' sindromi mijelodisplastiċi (MDS - myelodisplastic syndromes) jew lewkimja f'pazjenti fi provi kliniċi b'SCN ittrattati b'filgrastim.
English: Blood lactate dehydrogen ase increased
Maltese: lactate dehydrogen ase fiddemm
English: Gastrointestinal disorders
Maltese: Disturbi gastrointest inali
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: Pazjenti li jiżviluppaw sintomi ta' sindrome ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu trattament sintomatiku standard, li jista' jinkludi ħtieġa għal kura intensiva (ara sezzjoni 4.8).
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Maltese: F'firien tqal, ma ġiet osservata l-ebda tossiċità għall-omm jew għall-fetu b'dożi sa 575 μg/kg/jum.
English: • swelling in the hands and feet (oedema peripheral)
Maltese: • nefħa fl-idejn u fis-saqajn (edima periferali)
English: Dyspnoea Cougha
Maltese: Disurja Ematurja
English: Aspartate aminotransf erase increased Gammaglutamyl transferase increased
Maltese: aspartate aminotransf erase
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Maltese: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Maltese: Ġew irrapportati każijiet tas-sindrome ta' Sweets (dermatożi akuta newtrofilika bid-deni) f'pazjenti ttrattati b'filgrastim.
English: If required, Ratiograstim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Maltese: Jekk ikun hemm bżonn, Ratiograstim jista' jiġi dilwit f'soluzzjoni għal infużjoni ta' glucose 50 mg/mL (5%).
English: You will hear a “click”, which confirms activation of the safety device.
Maltese: Se tisma “klikk”, li tikkonferma l-attivazzjoni tat- tagħmir tas sigurtà.
English: EU/1/08/444/001 EU/1/08/444/002 EU/1/08/444/003 EU/1/08/444/004 EU/1/08/444/009 EU/1/08/444/010 EU/1/08/444/005 EU/1/08/444/006 EU/1/08/444/007 EU/1/08/444/008 EU/1/08/444/011 EU/1/08/444/012
Maltese: EU/1/08/444/009 EU/1/08/444/010 EU/1/08/444/005 EU/1/08/444/006
English: Each mL of solution for injection/infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Maltese: Kull mL ta' soluzzjoni għall-injezzjoni/infużjoni fiha 60 miljun international units [MIU] (600 µg) ta' filgrastim.
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: 65 sena meta mqabbla ma' adulti iżgħar (> 18-il sena) li kienu qed jirċievu kimoterapija ċitotossika, u l-esperjenza klinika ma identifikatx differenzi fir-risponsi bejn pazjenti adulti anzjani u pazjenti adulti iżgħar.
English: Special precautions in normal donors undergoing PBPC mobilisation
Maltese: Prekawzjonijiet speċjali f'donaturi normali taħt proċedura ta' mobilizzazzjoni ta' PBPC
English: Based on reported data for another filgrastim product similar to the reference product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Maltese: Abbażi tad-data rrappurtata għal prodott ieħor li fih filgrastim simili għall-prodott ta' referenza, sejbiet komparabbli flimkien ma' żieda fil-malformazzjonijiet fil-fetu kienu osservati b'doża ta' 100 μg/kg/jum, doża tossika għall-omm li tikkorrispondi għal esponiment sistemiku ta' madwar 5090 darba l-esponimenti osservati f'pazjenti trattati bid-doża klinika ta' 5 μg/kg/jum.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-data fit-tabelli t'hawn taħt tiddeskrivi r-reazzjonijiet avversi rrappurtati minn provi kliniċi u rappurtar spontanju.
English: Infections and malignancies causing myelosuppression
Maltese: Infezzjoniji et u infestazzjo nijiet
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà 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: Respiratory failurea Pulmonary oedemaa
Maltese: Edima pulmonaria
English: EU/1/08/444/005 1 pre-filled syringe EU/1/08/444/006 5 pre-filled syringes EU/1/08/444/008 10 pre-filled syringes EU/1/08/444/011 1 pre-filled syringe with safety device EU/1/08/444/012 5 pre-filled syringes with safety device
Maltese: EU/1/08/444/005 1 siringa mimlija għal-lest EU/1/08/444/006 5 siringi mimlija għal-lest EU/1/08/444/008 10 siringi mimlija għal-lest EU/1/08/444/011 1 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra EU/1/08/444/012 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra
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 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Maltese: Jista' jkun li pazjenti li għaddew minn terapija mijelosoppressiva estensiva ħafna ma jkollhomx mobilizzazzjoni suffiċjenti ta' PBPC biex jaslu għall-għadd minimu rakkomandat (≥ 2.0 x 106 CD34+
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 109/L.
Maltese: Madankollu, matul il-perjodu ta' għoti ta' filgrastim għall-mobilizzazzjoni ta' PBPC, filgrastim għandu jitwaqqaf jew id-dożaġġ titnaqqas jekk l-għadd ta' lewkoċiti jitla' għal > 70 x 109/L.
English: Ratiograstim 30 MIU/0.5 mL solution for injection/ infusion Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
Maltese: Ratiograstim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni Ratiograstim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni/infużjoni
English: Acute respiratory distress syndromea
Maltese: Sindrome ta' diffikultà respiratorja akutaa i
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Maltese: Irid jiġi kkunsidrat il-waqfien temporanju jew it-tnaqqis fid-doża ta' filgrastim f'pazjenti b'newtropenija kronika u qawwija li jiżviluppaw tromboċitopenija (l-għadd tal-plejtlits < 100 x 109/L).
English: EU/1/08/444/001 1 pre-filled syringe EU/1/08/444/002 5 pre-filled syringes EU/1/08/444/004 10 pre-filled syringes EU/1/08/444/009 1 pre-filled syringe with safety device EU/1/08/444/010 5 pre-filled syringes with safety device
Maltese: EU/1/08/444/001 1 siringa mimlija għal-lest EU/1/08/444/002 5 siringi mimlija għal-lest EU/1/08/444/004 10 siringi mimlija għal-lest EU/1/08/444/009 1 siringa mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra EU/1/08/444/010 5 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra