FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: F'każijiet rari ħafna , jista' jkun hemm żieda żgħira momentarja fit-temperatura tar-rektum wara t-tilqima.(“ rari ħafna” tikkorrispondi għal frekwenza ta' effetti mhux mixtieqa inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml, 8 x 500 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun ta' 20ml, 50 ml, 100 ml
English: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Maltese: kunjetti ta' 100 ml, ħġieġ tat-tip II
English: PACKAGE SIZE 100 ml (50 doses) 500 ml (250 doses)
Maltese: 100 ml (50 doża)
English: Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU* Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log2 GMNU* Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU*
Maltese: 22 log2 GMNU Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU
English: Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Maltese: Immunizzazzjoni attiva tal-ħnieżer mill-età ta' 56 ġurnata 'l fuq inklużi majjaliet fit-tqala kontra l influwenza tal-ħnieżer ikkawżata mis-sottotipi H1N1, H3N2 u H1N2 biex tnaqqas is-sinjali kliniċi u lammont ta' virus fil-pulmun wara infezzjoni.
English: IM Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: MARKETING AUTHORISATION NUMBER EU/2/09/103/001-007
Maltese: EU/2/09/103/001-006
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 20 ml (10 dożi),
English: Flanged caps
Maltese: TAGĦRIF
English: Piglets:
Maltese: GĦAL:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: 37/2010 tindika li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Maltese: Meta bħala ‘booster' tiġi amministrata doża waħda tal-vaċċin 14-il ġurnata qabel li l-majjala li kienet diġa mlaqqma tferragħ, il-vaċċin jistimola immunita' attiva biex tipprovdi immunita' derivata mill-omm liz-zgħar kontra s-sottotipi H1N1, H3N2 u H1N2 tal-virus talInfluwenza A tal-ħnieżer.
English: Use during pregnancy, lactation or lay
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVISTA, U/JEW UŻU
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Maltese: - Bejn l-età ta'56 u 96 jum, b'intervall ta' 3 ġimgħat bejn injezzjoni u oħra biex jinkiseb tul ta'
English: To be supplied only on veterinary prescription.
Maltese: Tħallatx ma' ebda prodott mediċinali ieħor.
English: Generally, maternallyderived antibodies induced by vaccination last for approx. 5-8 weeks after birth.
Maltese: Ġeneralment, l-antikorpi derivati mill-omm indotti mit-tilqim idumu bejn wieħed u ieħor minn 5 sa 8
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju jew lill-ispiżjar tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Can be used during pregnancy and lactation.
Maltese: Influwenza A tal ħnieżer.
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 2 ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull doża ta' 2 ml fiha:
English: List of excipients
Maltese: ANNESS I KARATTERISTIĊI
English: Cardboard box with 1 glass or PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Maltese: Kaxxa tal-kartun b'kunjett tal-ħġieġ ta' 10 dożi (20 ml), 25 doża (50 ml) jew 50 doża (100 ml) b'tapp tal-lastku u għatu bi flanġa.
English: PHARMACEUTICAL FORM Clear, yellowish orange to pink coloured suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni ċara ta' kulur oranġjo safrani għal roża għall-injezzjoni
English: PACKAGE LEAFLET: Respiporc FLU3 Suspension for injection for pigs
Maltese: RESPIPORC FLU3 suspensjoni għall-injezzjoni għall-ħnieżer.
English: Shelf-life
Maltese: L-ISEM
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination.
Maltese: F'każijiet rari ħafnajista jkun hemm żieda żgħira momentarja fit-temperatura tar-rektum wara t-tilqima.
English: Maternally-derived immunity in the piglets interacts with antibody induction.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bioloġika intiża biex tipproduċi immunità attiva,
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Maltese: 3 DIKJARAZZJONI TAS-SUSTANZA(I)
English: IMMUNOLOGICAL PROPERTIES
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: Oral use sachet (PET/alu/LLDPE)
Maltese: Użu orali qartas (PET/alu/LLDPE)
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Din il-mediċina tingħata permezz ta' injezzjoni, jew permezz ta' infużjoni (dripp) ġol-vini (IV) jew permezz ta' injezzjoni taħt il-ġilda (SC) fit-tessut kemm kemm taħt il-ġilda.
English: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES Accord Healthcare S.L.U.
Maltese: AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / HR / HU / IS / LT / LV / LX/ MT / NL / NO / PT / PL / RO / SE / SI / SK / UK/ ES
English: FR Accord Healthcare France SAS
Maltese: Accord Healthcare France SAS
English: MedDRA system organ class
Maltese: Sistema talklassifika tal-organi MedDRA
English: Very rare: < 1/10,000
Maltese: Rari ħafna: < 1/10,000
English: Accofil contains sorbitol and sodium
Maltese: Accofil fih sorbitol u sodium
English: Common: ≥ 1/100 to < 1/10
Maltese: Komuni: ≥ 1/100 to < 1/10
English: µg/kg/day).
Maltese: mikrogramma/kg/kuljum).
English: When diluted in 5% glucose, Accofil 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, Accofil hu kompatibbli mal-ħġieġ u ma' varjetà ta' plastiks li jinkludu PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000
Maltese: Mhux komuni: ≥ 1/1,000 to < 1/100 Rari: ≥ 1/10,000 to < 1/1,000
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 kellhom < 55 sena b'ċitoġenika tajba [t(8;21), t(15;17), u inv(16)] ma ġewx determinati s'issa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 18.09.2014
Maltese: Data tal-ewwel awtorizzazzjoni: 18.09.2014
English: See section 4.
Maltese: Ara sezzjoni4.
English: • alcohol swab or similar.
Maltese: • msielaħ tal-alkoħol jew simili.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Maltese: • uġigħ u nefħa fil-ġogi, simili għall-gotta (psewdogotta)
English: Oropharyngeal paina,e
Maltese: Sogħlaa Uġigħ orofarinġeal ia,e
English: INFORMATION IN BRAILLE Accofil 30 MU/0.5 ml
Maltese: Accofil 30 MU/0.5 ml
English: Middlesex, HA1 4HF United Kingdom
Maltese: North Harrow, Middlesex HA1 4HF Ir-Renju Unit
English: 1 pre-filled syringe (0.5 ml) + 1 alcohol swab “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs” “7 pre-filled syringe (0.5 ml) + 7 alcohol swabs”
Maltese: 1 siringa mimlija għal-lest b'0.5 ml + 1 imselħa tal-alkoħol “3 siringi mimlija għal-lest b'0.5 ml + 3 imsielaħ tal-alkoħol” “5 siringi mimlijin għal-lest (0.5 ml) + 5 imsielaħ tal-alkoħol” “10 siringi mimlijin għal-lest (0.5 ml) + 10 imsielaħ tal-alkoħol” “7 siringi mimlijin għal-lest (0.5 ml) + 7 imsielaħ tal-alkoħol”
English: N Acute Grade II - IV GvHD
Maltese: GvHD Akuta ta' Grad II-IV
English: Mobilization of PBPC
Maltese: PBPC
English: Pull straight as shown in pictures 1 and 2.
Maltese: Iġbed dritt kifmuri fi stampi 1 u 2.
English: Pseudogout (chondrocalcinosis pyrophosphate)
Maltese: Psewdogotta (kondrakalċinożi pirofosfat)
English: If required, Accofil may be diluted in 5% glucose.
Maltese: Jekk ikun meħtieġ, Accofil jista' jiġi dilwit f'5% ta' glucose.
English: > 1.0 x 109/L for 3 consecutive days
Maltese: >1.0x109/L għal 3jiem konsekuttivi
English: INFORMATION IN BRAILLE Accofil 48 MU/0.5 ml
Maltese: Accofil 48 MU/0.5 ml
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 24 µg/kg/day.
Maltese: Fi studji kliniċi, 97% talpazjenti li rrispondew kellhom rispons sħiħ f'dożi ta' ≤ 24 µg/kg/jum.
English: Accofil contains sorbitol (E420) as an excipient at a concentration of 50 mg/ml.
Maltese: Accofil fih sorbitol (E420) bħala eċċipjent f'konċentrazzjoni ta' 50 mg/ml.
English: 1 pre-filled syringe (0.5 ml) + 1 alcohol swab “5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs”
Maltese: 1 siringa mimlija għal-lest b'0.5 ml + 1 imselħa tal-alkoħol “5 siringi mimlija għal-lest b'0.5 ml + 5 imsielaħ tal-alkoħol” “3 siringi mimlijin għal-lest (0.5 ml) + 3 imsielaħ tal-alkoħol” “10 siringi mimlijin għal-lest (0.5 ml) + 10 imsielaħ tal-alkoħol”
English: The timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 which is often sufficient.
Maltese: Iż-żmien ta' lewkaferesi: 1 jew 2 lewkaferesi f'jiem 5 u 6, li ta' spiss huma suffiċjenti.
English: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Maltese: Stabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita kienet demostrata għal 24 siegħa f'temperatura ta' 2°C - 8°C.
English: Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Maltese: Accofil hu indikat għall-mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali (PBPCs).
English: • bumpy skin rash (rash macuo-papular)
Maltese: • raxx tal-ġildda mqabbeż (raxx makulopapulari)
English: Acute respiratory distress syndromea
Maltese: Sindrome ta' problema respiratorja akutaa
English: Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.
Maltese: Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, u ilma għall-injezzjonijiet.
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: Pharmacotherapeutic group: immunostimulants, colony stimulating factors, ATC code: L03AA02 Accofil is a biosimilar medicinal product.
Maltese: Kategorija farmakoterapewtika: immunostimulanti, fatturi li jistimulaw kolonji ta' granuloċiti, Kodiċi ATC:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 60 miljun unità (MU) (ekwivalenti għal 600 mikrogramma [μg]) ta'
English: The assessment of undesirable effects is based on the following frequency data:
Maltese: Il-valutazzjonita 'effettimhux mixtieqahija bbażatafuq id-datata' frekwenzasegwenti:
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: 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 fl-Adulti (ARDS).
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħall-proteini terapewtiċikollha, hemm potenzjal għal immunoġeniċità.
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'
English: Leukocytosis (WBC > 50 x 109/L) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim treatment and leukapheresis was observed in 35% of donors.
Maltese: Lewkoċitożi Lewkoċitożi (WBC > 50 x 109/L) ġiet osservata f'41% tad-donaturi u tromboċitopenija temporanja
English: Reduce to 0.5 MU (5 µg)/kg/day
Maltese: Naqqas għal 0.5MU (5 µg)/kg/jum
English: • Sickle cell anaemia, accofil may cause sickle cell crisis.
Maltese: • Anemija taċ-ċelloli Sickle, Accofil jista' jikkawża kriżi taċ-ċelloli sickle.
English: Pulmonary haemorrhage Hypoxia
Maltese: Emorraġija pulmonari Ipoksija
English: PHARMACEUTICAL PARTICULARS
Maltese: Intas Pharmaceuticals
English: Reduce to 0.5 MU (5µg) /kg/day
Maltese: Naqqas għal 0.5MU (5µg) /kg/jum
English: Proteinuria Urine abnormality Glomerulonephr
Maltese: Anormalità fl-awrina Glomerulone frite
English: In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 µg/kg/day.
Maltese: Fil-firien tqal, ma ġiet osservata ebda tossiċità fl-omm jew fil-fetu f'dożi sa 575 µg/kg/kuljum.
English: Accofil contains the active ingredient filgrastim.
Maltese: Accofil fih is-sustanza attiva filgrastim.
English: Hyperuricaemi a
Maltese: Uġigħa
English: In randomised clinical trials, a subcutaneous dose of 230 microgram/m2/day (4.0 to 8.4 microgram/kg/day) was used.
Maltese: Fi provi kliniċi randomizzati, intużat doża taħt il-ġilda ta' 230 mikrogramma/m2/kuljum (bejn 4.0 u 8.4
English: Sweets syndrome (acute febrile neutrophilic dermatosis) Cutaneous vasculitisa
Maltese: (dermatożi newtrofilika bid-deni akuta) Vaskulite tal-ġildaa
English: Gastrointes tinal disorders
Maltese: Disturbi gastrointestinali
English: Diarrhoeaa,e Vomitinga,e Nauseaa
Maltese: Dijareaa,e Rimettara,e Dardira
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Maltese: Filgrastim ma affettwax l-attività riproduttiva jew il-fertilità fil-firien irġiel jew nisa (ara sezzjoni 5.3).
English: Accofil 30 MU/0.5 ml (0.6 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Maltese: Accofil 30 MU/0.5 ml (0.6mg/ml) soluzzjoni għall-injezzjoni jew għall-infużjoni filgrastim
English: Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution over 30 minutes.
Maltese: Kimoterapija ċitotossika stabbilita Filgrastim jista' jingħata bħala injezzjoni ta' kuljum taħt il-ġilda jew alternattivament bħala infużjoni ta' kuljum ġol-vini dilwit soluzzjoni ta' 50 mg/ml (5%) ta' glucose fuq 30 minuta.
English: Other medicines and Accofil
Maltese: Mediċini oħra u Accofil
English: Discontinue filgrastim
Maltese: Waqqaf filgrastim
English: For further instructions on dilution with glucose 50 mg/ml (5%) solution prior to infusion see section 6.6.
Maltese: Għal istruzzjonijiet addizzjonali dwar id-dilwizzjoni b'soluzzjoni ta' 50 mg/ml (5%) ta' glucose qabel l-infużjoni, ara sezzjoni 6.6.
English: Lung infiltration a
Maltese: Disturbi fissistema immuni a
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 sezzjoni 4.4 u 5.1).
English: Accofil treatment will last for 4 to 5 days.
Maltese: Il-kura b'Accofil se ddum għal 4 sa 5 ijiem.
English: Transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Maltese: Tromboċitopenija temporanja (plejtlits < 100 x 109/L) wara l-għoti ta' filgrastim u lewkaferesi, ġiet osservata f'35% tal-pazjenti studjati.
English: Accofil must not be diluted with sodium chloride solutions.
Maltese: Accofil m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: Special precautions in patients with acute myeloid leukaemia (AML)
Maltese: Prekawzjonijiet speċjali f'pazjenti b'lewkimja majelojde akuta (AML)
English: See leaflet for further information.
Maltese: Ara lfuljett ta' tagħrif għal aktar informazzjoni.
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: Pazjenti li kellhom terapija majelsoppressiva estensiva ħafna fil-passat, jistgħu ma jurux mobilizzazzjoni suffiċjenti PBPC biex jiksbu l-ammont minimu rakkomandat (2.0 x 106 CD34+ ċellula/kg) jew l-aċċelerazzjoni tal-irkuprar tal-plejtlits għall-istess grad.
English: What Accofil is
Maltese: Tużax Accofil
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: Il-lewkaferesi għandha titwettaq matul il-perjodu meta l-ANC jitla' minn < 0.5 x 109/L għal > 5.0 x 109/L.
English: Ahmedabad - 382213 Gujarat
Maltese: Plot no: 423/P/A Sarkhej Bavla Highway Village Moraiya; Taluka Sanand, Ahmedabad - 382213 Gujarat L-Indja
English: It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Maltese: Jappartjeni għal grupp ta' proteini msejħa cytokines, u hu simili ħafna għal proteina naturali (fattur tal-istimulazzjoni tal-kolonji tal-granuloċiti [G-CSF]) magħmul minn ġismek stess.
English: European Retrospective Study b
Maltese: Studju Retrospettiv Ewropew b
English: Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology.
Maltese: Filgrastim hu proteina magħmula f'batterji msejħa Escherichia coli minn teknoloġija ta' DNA rikombinanti.
English: In normal donors, dyspnoea has been reported commonly and other pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, and hypoxia) have been reported uncommonly.
Maltese: F'donaturi normali, qtugħ ta ‘nifs kient rappurtata spiss u avvenimenti avversi pulmonari (emoptisi, emorraġija pulmonari, infiltrazzjoni fil-pulmun, nuqqas ta' ossiġnu) ġew irrappurtati b'modmhux komuni.
English: This medicine contains sorbitol.
Maltese: Dan il-prodott mediċinali fih sorbitol.
English: EU/1/14/946/001 EU/1/14/946/002 EU/1/14/946/005 EU/1/14/946/006 EU/1/14/946/007 EU/1/14/946/008 EU/1/14/946/009 EU/1/14/946/010 EU/1/14/946/017
Maltese: EU/1/14/946/006 EU/1/14/946/007 EU/1/14/946/008 EU/1/14/946/009 EU/1/14/946/010
English: Based on reported data for another filgrastim product similar to Accofil, 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: Abbażi tad-dejta rrapportata għal prodott ieħor li fih filgrastim simili għal Accofil, kienu osservati sejbiet simili flimkien ma' żieda fil-malformazzjonijiet fetali b'100 µg/kg/kuljum, doża tossika għall-omm li kienet tikkorrispondi għal espożizzjoni sistemika ta' madwar 50-90 darba l espożizzjonijiet osservati f'pazjenti kkurati bid-doża klinika ta' 5 µg/kg/kuljum.
English: Oedema peripherale
Maltese: Telqae Edema periferalie
English: Ver y rare
Maltese: Rar i ħaf na
English: Leukocytosisa
Maltese: Lewkoċitożia
English: Respiratory failurea
Maltese: Disurija Ematurija
English: Filgrastim for PBPC mobilisation when used alone:
Maltese: Filgrastim għall-mobilizzazzjoni tal-PBPC meta jintuża waħdu:
English: Venoocclusive diseased
Maltese: Emoptisi Dispnea
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Maltese: Il-grad ta' varjazzjoni bejn pazjenti individwali u bejn l-assaġġi tal laboratorju ta' ċelluli CD34+ ifisser li paragun dirett bejn studji differenti hu diffiċli.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Maltese: G-CSF jista' jippromwovi t-tkabbir ta' ċelluli majelodje in vitro u effetti simili jistgħu jiġu osservati wkoll fuq xi ċelluli mhux majelodje in vitro.
English: Accofil and severe chronic neutropenia (low number of a type of white blood cells)
Maltese: Accofil u newtropenija kronika severa (numru baxx ta' tip ta' ċelluli tad-demm bojod)
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: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi l-aktar serji li jistgħu jseħħu waqt kura b'Filgrastim jinkludu: reazzjoni anafilattika, avvenimenti avversi pulmonari serji (inkluż pulmonite interstizjali u ARDS), syndrome ta' tnixxija kapillari, splenomegalija severa/milsa mifqugħa, trasformazzjoni għal sindrome majelodisplastiku jew lewkimja f'pazjenti b'SCN, GvHD f'pazjenti li jirċievu trasferiment alloġeniku tal-mudullun jew trapjant taċ-ċelluli proġenituri taċ-ċelluli tad-demm periferali u kriżi tas sickle cells f'pazjenti b'marda tas-sickle cells.
English: Musculoskeletal painc
Maltese: Uġigħ muskoloskeletr iku ċ
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Glomerulonefrite ġiet irrapportata f'pazjenti li kienu qed jirċievu filgrastim u pegfilgrastim.
English: This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (0.035 mg) f'kull doża, i.e. hu essenzjalment ‘ħieles mis-sodium'.
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Maltese: Għall-mobilizzazzjoni ta' PBPCs f'donaturi normali qabel trapjant alloġeneiku tal-PBPC