FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.
Maltese: Peress li Halimatoz huwa mediċina bijosimili, l-istudji dwar l-effettività u s-sigurtà ta' adalimumab li saru b'Humira m'għandhomx bżonn jiġu ripetuti kollha għal Halimatoz.
English: An overview of Halimatoz and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Halimatoz u għalfejn huwa awtorizzat fl-UE
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Maltese: Dawn il-pakketti se jinkludu informazzjoni dwar is-sigurtà tal-mediċina.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat.
Maltese: TNF huwa involut flikkawżar tal-infjammazzjoni u jinsab f'livelli għoljin f'pazjenti li jkollhom il-mard li Halimatoz jintuża biex jikkura.
English: Package size blister (PVC/alu) perforated blister (PVC/alu) non perforated
Maltese: Daqs tal-pakkett strixxa (tal-PVC/Alu) mtaqqba strixxa (tal-pvc/Alu) mhux imtaqqba
English: The full EPAR for Pantecta Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment.
Maltese: Fit-tieni studju, 70% tal-pazjenti li kienu qegħdin jieħdu pantoprazole (121 minn 172) u 59% ta' dawk li kienu qegħdin jieħdu ranitidine (102 minn 172) ma kellhomx qrusa fl-istonku wara ġimagħtejn ta'
English: The active substance in Pantecta Control, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantecta Control, pantoprazole, hija inibitur tal-pompa tal-proton.
English: This is a summary of the European public assessment report (EPAR) for Pantecta Control.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pantecta Control.
English: Pantecta Control is a medicine that contains the active substance pantoprazole.
Maltese: Pantecta Control huwa mediċina li fiha s-sustanza attiva pantoprazole.
English: Pantecta Control pantoprazole
Maltese: Informazzjoni oħra dwar Pantecta Control
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantecta Control on 12 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Pantecta Control fit-12 ta' Ġunju 2009.
English: What is the risk associated with Pantecta Control?
Maltese: X'inhu r-riskju assoċjat ma' Pantecta Control?
English: What is Pantecta Control?
Maltese: Kif jaħdem Pantecta Control?
English: The reference medicine, Pantecta, is only available with a prescription.
Maltese: Il-mediċina ta' referenza, Pantecta, hija disponibbli biss permezz ta' riċetta tat-tabib.
English: Pantecta Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantecta.
Maltese: Pantecta Control huwa simili għal ‘mediċina ta' referenza' msejħa Pantecta li hija diġà awtorizzata fl
English: How does Pantecta Control work?
Maltese: Liema benefiċċji wera Pantecta Control waqt l-istudji mwettqa?
English: Pantecta Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Maltese: Pantecta Control jintuża għall-kura għal żmien qasir tas-sintomi ta' rifluss tal-aċidu fl-adulti.
English: For the full list of all side effects reported with pantoprazole, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'pantoprazole,
English: The CHMP therefore decided that Pantecta Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pantecta Control huma akbar mirriskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Pantecta Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Maltese: Pantecta Control m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal pantoprazole, soja jew għal xi sustanza oħra tiegħu.
English: The most common side effects with Pantecta Control (seen in around 1 patient in 100) are diarrhoea and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Pantecta Control (li dehru f'madwar pazjent wieħed minn kull 100) huma dijarrea u wġigħ ta' ras.
English: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, India
Maltese: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, L-Indja
English: Latvija STADA Arzneimittel AG
Maltese: STADA Arzneimittel AG
English: Aspartate aminotransferase increased
Maltese: Żieda ta' Aspartate aminotransferase
English: Gamma-glutamyl transferase increased
Maltese: Żieda ta' Gamma-glutamyl transferase
English: World Trade Center Moll de Barcelona s/n, Edifici Est 6ª planta 08039 Barcelona Spain
Maltese: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,
English: • The active substance is filgrastim.
Maltese: • Is-sustanza attiva hi filgrastim.
English: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Telephone +30/2106776550
Maltese: Ψυχικό, 15451, Αθήνα Τηλ:+30/2106776550
English: EG LABO-Laboratoires Eurogenerics SAS Telephone +33/1-46.94.86.86
Maltese: EG LABO-Laboratoires Eurogenerics SAS Tél:+33/1-46.94.86.86
English: STADA Nordic ApS Telephone +45/44.85.99.99
Maltese: STADA Nordic ApS Tel:+45/44.85.99.99
English: Grastofil contains sorbitol
Maltese: Grastofil fih sorbitol
English: Respiratory failure a
Maltese: Insuffiċjenza respiratorja a
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Maltese: 9/L) ġiet osservata f'41% tad-donaturi normali u tromboċitopenija temporanja (plejtlits < 100 x 10
English: Date of first authorisation: 18 October 2013 Date of latest renewal: 4 October 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ott 2013 Data tal-aħħar tiġdid: 4 ott 2018
English: When diluted in 5% glucose, Grastofil 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 f'5% ta' glucose, Grastofil hu kompatibbli mal-ħġieġ u ma' varjetà ta' plastiks li jinkludu PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: Grastofil contains the active substance filgrastim.
Maltese: Grastofil fih is-sustanza attiva filgrastim.
English: Centrafarm BV Telephone +31/7650.81.000
Maltese: Nederland Centrafarm BV Tel: +31/7650.81.000
English: Alopecia a
Maltese: Alopeċja a
English: 6.2 Incompatibilities
Maltese: 6.2 Inkompatibbiltajiet
English: N Acute grade II - IV GvHD
Maltese: GvHD akuta ta' grad II-IV
English: Leukocytosis Leukocytosis (WBC > 50 x 10
Maltese: Lewkoċitożi Lewkoċitożi (WBC > 50 x 10
English: • abnormal x-rays of the lungs (lung infiltration)
Maltese: • x-rays anormali tal-pulmun (infiltrazzjoni fil-pulmun)
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 f'pazjenti b'AML de novo li għandhom < 55 sena b'ċitoġenetika tajba [t(8; 21), t(15; 17), u inv(16)] għadhom ma ġewx determinati s'issa.
English: Telephone +420/257-888.111
Maltese: Tel: +420/257-888.111
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow (BM) transplantation
Maltese: Riskju relattiv (95% CI) ta' GvHD u TRM wara l-kura b'G-CSF wara trapjant tal-mudullun (BM)
English: Grastofil contains sodium
Maltese: Grastofil fih sodium
English: In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 μg/kg/day.
Maltese: F'firien tqal, l-ebda tossiċità materna jew fetali ma ġiet osservata f'dożi sa 575 μg/kg/jum.
English: Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in Escherichia coli (BL21) by recombinant DNA technology.
Maltese: Filgrastim (fattur li jistimula kolonji ta' granuloċiti umani methionyl rikombinanti) hu magħmul f' Esherichia coli (BL21) minn teknoloġija DNA rikombinanti.
English: This medicinal product contains 50 mg sorbitol.
Maltese: Dan il-prodott mediċinali fih 50 mg sorbitol.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Maltese: • uġigħ u nefħa tal-ġogi, simili għal gotta (psewdogotta)
English: Each mL of solution contains 50 mg of sorbitol (E420) (see section 4.4).
Maltese: Kull mL ta' soluzzjoni fih 50 mg ta' sorbitol (E420) (ara sezzjoni 4.4).
English: Splenomegaly a
Maltese: Splenomegalija a
English: Telephone +44/1484-842.217
Maltese: Tel:+44/1484-842.217
English: Common (≥ 1/100 to <
Maltese: Komuni (≥ 1/100 sa
English: Telephone +43/1-367.85.85.0
Maltese: Tel:+43/1-367.85.85.0
English: Chronic GvHD
Maltese: GvHD kronika
English: Pulmonary oedema a
Maltese: Edema pulmonari a
English: 9/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Maltese: 9/L) wara l-għoti ta' filgrastim u lewkaferesi, ġiet osservata f'35% tal-pazjenti studjati.
English: Grastofil contains 50 mg sorbitol in each ml.
Maltese: Grastofil fih 50 mg sorbitol f'kull ml.
English: Acute respiratory distress syndrome a
Maltese: Sindrome ta' problema respiratorja akuta a
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Maltese: Immunostimulanti, fatturi li jistimulaw il-kolonji, Kodiċi ATC:
English: Rare (≥ 1/10,000 to <
Maltese: Rari (≥ 1/10,000 sa
English: Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 mL of 200 mg/mL (20%) human albumin solution added.
Maltese: F'volum finali tal-injezzjoni ta' 20 mL, dożi totali ta' filgrastim ta' inqas minn 30 MU (300 µg) għandhom jingħataw ma' soluzzjoni ta' 0.2 mL ta' 200 mg/mL (20%) albumina fis-serum uman miżjuda.
English: Diarrhoea a, e
Maltese: Dijarea a, e
English: Musculoskeletal pain c
Maltese: Uġigħ muskoloskeletriku ċ
English: In patients with severe chronic neutropenia (SCN)
Maltese: F'pazjenti b'newtropenija kronika severa (SCN)
English: Oedema peripheral e
Maltese: Edima periferali
English: Each syringe of 0.5 mL solution contains 48 MU (480 micrograms) of filgrastim (960 micrograms/mL).
Maltese: Kull siringa b'0.5 mL ta' soluzzjoni fiha 48 MU (480 mikrogramma) ta' filgrastim (960 mikrogramma/mL).
English: Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Maltese: Grastofil hu indikat għall-mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali (PBPCs).
English: Grastofil is a biosimilar medicinal product.
Maltese: Grastofil hu prodott mediċinali bijoloġiku simili.
English: PharmaMt Ltd.
Maltese: CLONMEL Healthcare Ltd.
English: Rash maculopapular
Maltese: Raxx makulo-papulari
English: Absolute neutrophil count (ANC)
Maltese: Għadd assolut tan-newtrofili (ANC)
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Maltese: Jekk inti donatur ta' ċelluli staminali, irid ikollok bejn 16 u 60 sena.
English: Instructions for injecting Grastofil
Maltese: Istruzzjonijiet għall-injezzjoni Grastofil
English: Dizziness may occur following the administration of filgrastim (see section 4.8).
Maltese: Jista' jkun hemm sturdament wara l-għoti ta' filgrastim (ara sezzjoni 4.8).
English: Telephone +385/1.3764.111
Maltese: STADA d.o.o Tel: +385/1.3764.111
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Maltese: Sindrome ta' Sweets (dermatosi newtrofilika akuta bid-deni)
English: Statistical analysis of the relationship between the number of CD34
Maltese: Analiżi statistika tar-relazzjoni bejn in-numru ta' ċelluli CD34
English: Uncommon (≥ 1/1,000 to <
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100)
English: The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Il-bidu ta' sinjali pulmonari, bħal sogħla, deni u qtugħ ta' nifs b'rabta ma' sinjali radjoloġiċi ta' infiltrati pulmonari u deterjorament fil-funzjoni pulmonari, jistgħu jkunu sinjali preliminari tas-Sindrome ta' Problemi Respiratorji Akut (ARDS).
English: Vomiting a, e
Maltese: Rimettar a, e
English: Discontinue Grastofil
Maltese: Waqqaf Grastofil
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 tal-marda trapjant kontra l-ospitu (graft versus host disease (GvHD)) u fatalitajiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeneiku tal-mudullun (ara sezzjoni 4.8 u 5.1).
English: Rash a
Maltese: Raxx a
English: • bumpy skin rash (rash macuo-papular)
Maltese: • raxx ibbuzzat fil-ġilda (raxx makulo-papulari)
English: Telephone +48/22 -737.79.20
Maltese: Tel: +48/22 -737.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Maltese: Każijiet tas-sindrome ta' Sweets (dermatożi newtrofilika akuta bid-deni) ġew irrappurtati f'pazjenti ttrattati b'filgrastim.
English: Loss of response to filgrastim
Maltese: Telf ta' rispons għal filgrastim
English: Based on reported data for another filgrastim product similar to Grastofil, comparable findings plus increased fetal 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: Ibbażat fuq dejta rrappurtata għal prodott ieħor ta' filgrastim simili għal Grastofil, sejbiet komparabbli flimkien ma' żieda fil-malformazzjonijiet tal-feti, ġew osservati f'doża ta' 100 μg/kg/jum, doża tossika għall-omm li tikkorrispondi għal esponiment sistemiku ta' madwar 50-90 darba tal-esponimenti osservati f'pazjenti kkurati bid-doża klinika ta' 5 μg/kg/jum.
English: Telephone +34/93-473.88.89
Maltese: Laboratorio STADA S.L. Tel: +34/93-473.88.89
English: Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Maltese: Grastofil hu indikat għall-kura ta' newtropenija persistenti (ANC inqas minn jew daqs 1.0 x 10
English: Permanently discontinue filgrastim in patients with clinically significant hypersensitivity.
Maltese: Waqqaf filgrastim b'mod permanenti f'pazjenti b'sensittività eċċessiva klinikament sinifikanti.
English: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injections.
Maltese: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, u ilma għall-injezzjonijiet.
English: Transient thrombocytopenia (platelets < 100 x 10
Maltese: Tromboċitopenija temporanja (plejtlits < 100 x 10
English: The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day.
Maltese: Id-doża tal-bidu tas-soltu hi bejn 0.1 miljun unità (1 mikrogramma) u 0.4 miljun unità (4 mikrogrammi) għal kull kilogramm ta' piż tal-ġisem kuljum.
English: Pulmonary haemorrhage
Maltese: Reazzjonijiet avversi pulmonari
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Maltese: 9/L jew iżjed ġie osservat f'inqas minn 5% tal-pazjenti bil-kanċer li kienu qed jirċievu filgrastim f'dożi ta' iktar minn 0.3 MU/kg/jum (3 mikrogrammi/kg/jum).
English: • you experience kidney injury (glomerulonephritis).
Maltese: • ikollok ħsara fil-kliewi (glomerulonefrite).
English: Medicinal products such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Maltese: Prodotti mediċinali bħal melphalan, carmustine (BCNU) u carboplatin, meta jingħataw fuq perjodi twal ta' żmien qabel ma wieħed jipprova l-mobilizzazzjoni tal-proġenituri, jistgħu jnaqqsu l-ammont tal-proġenituri.
English: Reduce to 0.5 MU/kg/day (5 micrograms/kg/day)
Maltese: MU/kg/jum (5 mikrogrammi/kg/jum)
English: Lung infiltration a
Maltese: Infiltrazzjoni fil-pulmun a
English: • alcohol wipes or similar.
Maltese: • biċċiet tal-alkoħol biex timsaħ jew xi ħaġa simili.
English: If required, Grastofil may be diluted in 5% glucose.
Maltese: Jekk ikun meħtieġ, Grastofil jista' jiġi dilwit f'5% ta' glucose.
English: Urine abnormality
Maltese: Anormalità flawrina
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 10
Maltese: Esponiment fil-passat għal prodotti mediċinali ċitotossiċi Pazjenti li kellhom terapija majelsoppressiva estensiva ħafna fil-passat, jistgħu ma jurux mobilizzazzjoni suffiċjenti PBPC biex jiksbu l-ammont minimu rakkomandat (2.0 x 10
English: Diluted filgrastim may be adsorbed to glass and plastic materials.
Maltese: Filgrastim dilwit jista' jiġi adsorbit mal-ħġieġ u materjali tal-plastik.
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Maltese: Għall-mobilizzazzjoni ta' PBPC f'donaturi normali qabel trapjant alloġeneiku tal-PBPC Pożoloġija
English: The timing of leukapheresis: one or two leukaphereses on days 5 and 6 which is often sufficient.
Maltese: Iż-żmien ta' lewkaferesi: lewkaferesi waħda jew tnejn f'jiem 5 u 6, li ta' spiss ikun suffiċjenti.
English: cells mean that direct comparison between different studies is difficult.
Maltese: ifisser li paragun dirett bejn studji differenti hu diffiċli.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Maltese: Madankollu, ma jistax jiġi eskluż riskju ta' promozzjoni ta' klonu majelodje malinn.
English: PRE-FILLED SYRINGE
Maltese: Vaskulite tal-ġilda
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Maltese: Kien hemm rapporti ta' GvHD u fatalitajiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeneiku tal-mudullun (ara sezzjonijiet 4.4 u 5.1).
English: For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms).
Maltese: Pereżempju, jekk tiżen 60 kilogramm, id-doża tiegħek ta' kuljum se tkun ta' 30 miljun unità (300 mikrogramma).
English: Graft versus Host Disease b
Maltese: Mard tat-Trapjant kontra l-Ospitu b
English: Hyperuricaemia
Maltese: Iperurikemija
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/kg/day (24 micrograms/kg/day).
Maltese: Fi studji kliniċi, 97% talpazjenti li rrispondew kellhom rispons sħiħ f'dożi ta' ≤ 2.4
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in cancer patients treated with filgrastim.
Maltese: Psewdogotta (chondrocalcinosis pyrophosphate) Psewdogotta (chondrocalcinosis pyrophosphate) ġiet irrappurtata f'pazjenti bil-kanċer ikkurati b'filgrastim.
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: L-iktar reazzjonijiet avversi serji li jistgħu jseħħu matul trattament b'filgrastim jinkludu: reazzjoni anafilattika, avvenimenti avversi pulmonari serji (inklużi pulmonite tal-interstizju u ARDS), sindrome ta' tnixxija kapillari, splenomegalija severa/ftuq tal-milsa, trasformazzjoni għal sindrome majelodisplastika jew lewkimja f'pazjenti b'SCN, GvHD f'pazjenti li jirċievu trasferiment alloġeniku tal-mudullun jew trapjant ta' ċelluli proġenituri taċ-ċelluli tad-demm periferali u kriżi taċ-ċelluli forma ta' minġel f'pazjenti bil-marda taċ-ċellula forma ta' minġel.
English: For maintenance of normal neutrophil counts
Maltese: Għall-manteniment ta' għadd normali ta' newtrofili
English: Meta-Analysis a
Maltese: MetaAnaliżi a
English: Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Maltese: Grastofil għandu jiġi dilwit f'20 mL ta' soluzzjoni ta' 5% ta' glucose (ara sezzjoni 6.6).
English: In clinical studies, > 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Maltese: Fi studji kliniċi, > 90% tal-pazjenti rrispondu b'dawn id-dożi, kisba ta 'taqlib ta' newtropenja f'medjan ta '2 ijiem.
English: Grastofil and severe chronic neutropenia (low number of a type of white blood cells)
Maltese: Grastofil u newtropenija kronika severa (numru baxx ta' tip ta' ċelluli tad-demm bojod)
English: BN
Maltese: N
English: EXP:
Maltese: Eżempju:
English: Each mL of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni fih 96 miljun unità (MU) (ekwivalenti għal 960 mikrogramma [μg]) ta' filgrastim.
English: The needle cover of the pre-filled syringe contains dry natural rubber (latex, see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastku naturali xott (latex, ara sezzjoni 4.4).
English: How long will I have to take Grastofil?
Maltese: Għal kemm żmien se jkolli nieħu Grastofil?
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal b'fatturi ta' tkabbir ematopoetiċi oħrajn, G-CSF wera karatteristiċi stimulanti in vitro fuq ċelluli endoteljali umani.
English: 9/L to
Maltese: 9/L
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Maltese: L-ebda differenzi globali fis-sigurtà jew l-effikaċja ma kienu osservati bejn l-fuq minn 65 sena meta mqabbla ma 'adulti iżgħar (> 18-il sena) suġġetti qed jirċievu kimoterapija ċitotossika u l-esperjenza klinika ma identifikatx differenzi fir-risponsi bejn il-pazjenti adulti anzjani u dawk iżgħar.
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni huma deni, uġigħ muskoluskeletriku (li jinkludi uġigħ fl-għadam, uġigħ fid-dahar, artralġja, majalġja, uġigħ fl-estremitajiet, uġigħ muskoluskeletriku, uġigħ muskoluskeletriku fis-sider, uġigħ fl-għonq), anemija, rimettar u dardir.
English: The safety and efficacy of Grastofil are similar in adults, children and adolescents receiving cytotoxic chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' Grastofil huma simili fl-adulti, it-tfal u l-adolexxenti li jkunu qed jirċievu kimoterapija ċitotossika.
English: The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose.
Maltese: Id-doża tal-bidu tas-soltu hi bejn 0.5 miljun unità (5 mikrogrammi) u 1.2 miljun unità (12-il mikrogramma) għal kull kilogramm ta' piż tal-ġisem kuljum f'dożi waħidhom jew doża maqsuma.