FrancophonIA/ELRC3.0 huggingface dataset:
English: Accofil 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: Accofil hu indikat għall-kura ta' newtropenija persistenti (ANC inqas minn jew daqs 1.0 x 109/L) f'adulti b'infezzjoni avvanzata tal-HIV, sabiex inaqqas ir-riskju ta' infezzjonijiet batterjali meta għażliet oħrajn għall-immaniġġjar tan-newtropenija ma jkunux adattati.
English: Thrombocytopenia Anaemiae
Maltese: Tromboċitope nja Anemijae
English: Transfusion reactione a See section 4.8, Description of selected adverse reactions b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section 4.8, Description of selected adverse reactions) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain,
Maltese: trasfużjonie aara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula bKien hemm rapporti ta' GvHD u fatalitajiet f'pazjenti wara trapjant alloġeneiku tal-mudullun (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: In those clinical trials, undesirable effects reported with equal frequency in cancer patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and pain.
Maltese: F'dawk l istudji kliniċi, l-effetti mhux mixtieqa rrappurtati bi frekwenza ugwali f'pazjenti bil-kanċer ikkurati b'filgrastim/kimoterapija u bil-plaċebo/kimoterapija kienu jinkludu dardir u rimettar, alopeċja, dijarea, għeja kbira, anoreksja, mukożite, uġigħ ta' ras, sogħla, raxx tal-ġilda, uġigħ fis-sider, dgħufija ġeneralizzata, uġigħ fil-griżmejn, stitikezza u wġigħ.
English: Dizziness may occur following the administration of Accofil (see section 4.8).
Maltese: Jista' jseħħ sturdament wara l-għoti ta' Accofil (ara sezzjoni 4.8).
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Maltese: Jekk inti donatur ta' ċelloli staminali, għandu jkollok bejn is-16 u s-60 sena.
English: Spleen size should be evaluated regularly.
Maltese: Id daqs tal-milsa għandu jiġi evalwat regolarment.
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Sindrome ta' Disturb Respiratorju Akut (ARDS - Acute Respiratory Distress Syndrome).
English: How do I prepare my Accofil injection?
Maltese: Kif nipprepara l-injezzjoni ta' Accofil?
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Maltese: Ma kien hemm ebda differenza fil-profili ta' sigurtà għal pazjenti pedjatriċi kkurati għal SCN.
English: For further instructions on dilution prior to infusion see section 6.6.
Maltese: Għalaktar struzzjonijietdwar id-dilwizzjoniqabel l-infużjoni, ara sezzjoni 6.6.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Maltese: G-CSF umana hi glikoproteina li tirregola l-produzzjoni u l-ħruġ ta' newtrofili funzjonali mill mudullun.
English: - The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Maltese: - Is-sustanzi l-oħra huma acetic acid, sodium hydroxide, sorbitol (E420) polysorbate 80 u ilma għall-injezzjonijiet.
English: Hypersensitivi ty
Maltese: Vaskulite tal-ġilda
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Maltese: Prekawzjonijiet speċjali f'reċipjenti ta' PBPC alloġeneiċi mobilizzati b'filgrastim
English: Splenomegaly is a direct effect of treatment with filgrastim.
Maltese: Splenomegalija hija effett dirett tal-kura b'filgrastim.
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: Mediċini bħal melphalan, carmustine (BCNU) u carboplatin, meta jingħataw fuq perjodi twal ta' żmien qabel ma wieħed jipprova lmobilizzazzjoni tal-proġenituri, jistgħu jnaqqsu l-ammont tal-proġenituri.
English: Cutaneous vasculitis
Maltese: Popolazzjoni speċjali
English: The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion.
Maltese: mikrogrammi) sa 1 miljun unità (10 mikrogrammi) għal kull kilogramm ta' piż tal-ġisem kuljum.
English: EU/1/14/946/003 EU/1/14/946/004 EU/1/14/946/011 EU/1/14/946/012 EU/1/14/946/013 EU/1/14/946/014 EU/1/14/946/015 EU/1/14/946/016 EU/1/14/946/018
Maltese: EU/1/14/946/011 EU/1/14/946/012 EU/1/14/946/013 EU/1/14/946/014
English: Information for injecting yourself
Maltese: L-inċidenza ta'
English: • trouble sleeping (insomnia)
Maltese: • diffikultà biex torqod (insonnja)
English: Malaisee
Maltese: Anzjani
English: Patients treated with myeloablative therapy followed by bone marrow transplantation Filgrastim is administered as an intravenous short-term infusion over 30 minutes or as a subcutaneous or intravenous continuous infusion over 24 hours, in each case after dilution in 20 ml of glucose 50 mg/ml (5%) solution.
Maltese: Filgrastim jingħata bħala infużjoni qasira ġol-vini fuq perjodu ta' 30 minuta jew bħala infużjoni kontinwa taħt il-ġilda jew ġol-vini fuq perjodu ta' 24 siegħa, f'kull każ wara d-dilwizzjoni f'20 mL ta' soluzzjoni ta' 50 mg/ml (5%) ta' glucose.
English: Dilution to a final concentration less than 0.2 MU (2 µg) per ml is not recommended at any time.
Maltese: Id-dilwizzjoni għal konċentrazzjoni finali ta' inqas minn 0.2 MU (2 µg/ml) mhijiex rakkomandata fi kwalunkwe ħin.
English: Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Maltese: filgrastim għandu jitwaqqaf jew id-dożaġġ tiegħu għandu jitnaqqas jekk l-għadd tal-lewkoċiti jitla' għal > 70 x 109/L.
English: Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 ml, corresponding to 0.6 mg/ml.
Maltese: MU (300 mikrogramma) ta' filgrastim f'0.5 ml, li jikkorrispondu għal 0.6 mg/ml.
English: Not know n disturbances
Maltese: Disturbi vaskulari
English: Splenomegaly and splenic rupture
Maltese: Splenomega lijaa
English: In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Maltese: Fi tfal u adulti b'newtropenija severa konġenitali, ċiklika, jew idjopatika, b'għadd assolut tan newtrofili (ANC) ta' ≤ 0.5 x 109/L, u storja medika ta' infezzjonijiet severi jew rikorrenti, l-għoti fit tul ta' Accofil hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' żmien ta' avvenimenti assoċjati mal-infezzjoni.
English: The results of flow cytometric analysis of CD34
Maltese: Sensittività eċċessiva għal mediċinaa
English: EU/1/14/946/005 - 1 prefilled syringe with a needle safety guard EU/1/14/946/008 - 5 prefilled syringes with a needle safety guard EU/1/14/946/007 - 3 prefilled syringe with a needle safety guard EU/1/14/946/010 - 10 prefilled syringe with a needle safety guard EU/1/14/946/017 - 7 prefilled syringe with a needle safety guard
Maltese: EU/1/14/946/005 - 1siringa mimlija għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/008 - 5 siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/007 - 3 siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/010 - 10 siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/017 - 7siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Maltese: Il-mobilizzazzjoni tal-PBPC għandha tiġi kkunsidrata biss f'donaturi li jissodisfaw il-kriterji taleliġibilità normali kliniċi u tal-laboratorju għal donazzjoni ta' ċelluli staminali.
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Maltese: F'donaturi normali, doża ta' 1 MU/kg/jum (10 mikrogrammi/kg/jum) mogħtija taħt il-ġilda għal 4-5 ijiem konsekuttivi, tippermetti l-ġbir ta' ≥ 4 x 106 CD34+ ċelluli/kg reċipjent BW fil-maġġoranza taddonaturi wara żewġ lewkaferesi.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Maltese: MU (15 µg) kull ml, lalbumina fis-serum uman (HSA) għandha tiġi miżjuda għal konċentrazzjoni finali ta' 2 mg/ml.
English: Splenomegalya Haemoglobin decreasede
Maltese: Tnaqqis flemoglobinae
English: Accofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Accofil li fih r-metHuG-CSF (filgrastim) jikkawża żidiet notevoli fl-għadd tan-newtrofili tad-demm periferali fi żmien 24 siegħa, b'żidiet żgħar fil-monoċiti.
English: Accofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Maltese: Accofil hu soluzzjoni ċara u bla kulur għall-injezzjoni jew għall-infużjoni f'siringa mimlija għallest,mmarkati bi 1/40 marki stampati minn 0.1 mL għal 1 ml fuq is-siringa, ma 'labra tal-injezzjoni.
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, mijalġja, uġigħ estrem, uġigħ muskoluskeletriku, uġigħ fis-sider muskoluskeletriku, uġigħ fl-għonq), anemija, rimettar u dardir.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).
Maltese: Kull siringa 0.5 ml fiha 30ta' filgrastim (0.6mg/ml).
English: Infections and infestations
Maltese: Infezzjonijet u infestazzjoniji et
English: Blood lactate dehydrogenase increased
Maltese: lactate dehydrogen ase fiddemm
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Maltese: Tagħtix filgrastim lil pazjenti b'passat ta' sensittività eċċessiva għal filgrastim jew pegfilgrastim.
English: Permanently discontinue filgrastim in patients with clinically significant hypersensitivity.
Maltese: Waqqaf għal kollox filgrastim f'pazjenti b'sensittività eċċessiva klinikament sinifikanti.
English: Muscle spasms Osteoporosis
Maltese: Jekk tinsa tuża Accofil
English: NAME OF THE MEDICINAL PRODUCT Accofil 48 MU/0.5 ml solution for injection/infusion filgrastim
Maltese: TAL-PRODOTT MEDIĊINALI Accofil 48 MU/0.5 ml soluzzjoni għall-injezzjoni/infużjoni filgrastim2.
English: Accofil is available in packs containing 1, 3, 5, 7 and 10 pre-filled syringes, with or without prefixed needle safety guard and alcohol swabs.
Maltese: Accofil hu disponibbli f'pakketti li fihom 1, 3, 5, 7 u 10 siringi mimlija għal-lest, bi jew mingħajr ilqugħ tas-sigurtà għal-labra mwaħħla għal-lest u msielaħ tal-alkoħol.
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4)
Maltese: Fl-istudji kliniċi u fl-isfond ta' wara t-tqegħid fis-suq, reazzjonijiet avversi pulmonari li kienu jinkludu mard interstizjali tal-pulmun, edema pulmonari, u infiltrazzjoni tal-pulmun ġew irrappurtati f'xi każijiet b'riżultat ta' waqfien tan-nifs jew sindrome ta' problemi respiratorji akuti (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: Leukocytosisa Splenic rupturea Sickle cell anaemia with crisis
Maltese: Anemija tassickle cells bi kriżi
English: Bronchitis Upper respiratory tract infection Urinary tract infection
Maltese: Insuffiċjenza respiratorjaa Edema pulmonaria Mard interstizjali tal-pulmuna Infiltrazzjoni fil
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurred on initial or subsequent treatment in clinical studies and in post-marketing experience.
Maltese: Reazzjonijiet ta' senisttività eċċessiva li jinkludu anafilassi, raxx, urtikarja, anġjoedema, dispneja u pressjoni baxxa, seħħew mal-kura inizjali jew matul kura sussegwenti fi studhi kliniċi u fl-esperjenza wara t-tqegħid.
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 micrograms/kg/day).
Maltese: MU/kg/jum (5 mikrogrammi/kg/jum).
English: The volume of distribution in blood is approximately 150 ml/kg.
Maltese: distribuzzjoni fid-demm huwa madwar 150 ml/kg.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Maltese: Ħġieġ ta' tip I b'labra ta' azzar li ma jsaddadx li hi mwaħħla b'mod permanenti fit-tarf u marki stampati ta' 1/40 għal gradazzjonijiet minn 0.1 ml sa 1 ml fuq il-bettija.
English: Graft versus Host Diseaseb
Maltese: Uġigħ fis sidera Astenjaa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).
Maltese: Kull siringa 0.5 ml fiha 48 ta' filgrastim (0.96mg/ml).
English: Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Maltese: Riskji assoċjati ma' żieda fid-dożi tal-kimoterapija Għandha tintuża attenzjoni speċjali meta wieħed jikkura pazjenti b'doża għolja ta' kimoterapija minħabba ma ntweriex riżultat imtejjeb tat-tumur, u dożi intensifikati ta' mediċini kimoterapewtiċi jistgħu jwasslu għal żieda fit-tossiċitajiet li jinkludu effetti kardijaċi, pulmonari, newroloġiċi, u dermatoloġiċi (jekk jogħġbok irreferi għall-informazzjoni dwar il-preskrizzjoni tal-mediċini talkimoterapija speċifika li jintużaw).
English: Musculoske letal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: • Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.
Maltese: • Ikollok sinjali f'daqqa ta' allerġija bħal raxx, ħakk jew ħorriqija tal-ġilda, nefħa tal-wiċċ, ixxofftejn, l-ilsien jew partijiet oħra tal-ġisem, qtugħ ta' nifs, tħarħir jew problemi fin-nifs peress li dawn jistgħu jkunu sinjali ta' reazzjoni allerġika severa.
English: EU/1/14/946/001 - 1 prefilled syringe EU/1/14/946/002 - 5 prefilled syringes EU/1/14/946/006 - 3 prefilled syringe EU/1/14/946/009 - 10 prefilled syringe
Maltese: EU/1/14/946/001- 1siringa mimlija għal-lest EU/1/14/946/002- 5 siringi mimlija għal-lest EU/1/14/946/006 - 3 siringi mimlijin għal-lest EU/1/14/946/009 - 10 siringi mimlijin għal-lest
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilization
Maltese: Prekawzjonijiet speċjali f'donaturi normali li tkun qed issirilhom mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali
English: Cases of Sweets syndrome (acute febrile dermatosis) have been reported in the post-marketing setting.
Maltese: Każijiet tas-sindrome ta' Sweets (dermatożi febbrili akuta) ġew irrappurtati fl-isfond ta' wara ttqegħid fis-suq.
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/L.
Maltese: (ANC >2.0x109/L).
English: Pre-filled syringe without needle safety guard b.
Maltese: Siringa mimlija għal-lest mingħajr ilqugħ tas-sigurtà tal-labra b.
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 tad-demm bojod ta' 100 x 109/L jew iżjed ġie osservat f'inqas minn 5% tal-pazjenti li kienu qed jirċievu filgrastim f'dożi ta' iktar minn 0.3 MIU/kg/jum (3 mikrogrammi/kg/jum).
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Maltese: Analiżi statistika tar-relazzjoni bejn in-numru ta' ċelluli CD34+ li jkunu infużi mill-ġdid u r-rata ta' rkuprar tal-plejtlits wara kimoterapija b'doża għolja tindika relazzjoni kumplessa iżda kontinwa.
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Maltese: • jekk ikollok reazzjoni allerġika li tinkludi dgħufija, il-pressjoni tad-demm titbaxxa, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa filwiċċ, xufftejn, ħalq, ilsien jew gerżuma (anġjoedema) u qtugħ ta' nifs (dispneja).Sensittività eċċessiva hi komuni f'pazjenti bil-kanċer;
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)
Maltese: • dulur u nefħa tal-kisja tal-apparat diġestiv li hemm mill-ħalq sal-anus (infjammazzjoni tal mukuża)
English: Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Maltese: INFORMAZZJONI GĦALL-UTENT Accofil 48 MU/0.5 ml (0.96mg/ml) soluzzjoni għall-injezzjoni jew għall-infużjoni filgrastim
English: Sweets syndrome (acute febrile neutrophili c dermatosis) Cutaneous
Maltese: (dermatożi newtrofilika bid-deni akuta)
English: In the post-marketing setting, isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Maltese: Fl-isfond ta' wara t-tqegħid fis-suq, każijiet iżolati ta' kriżijiet tas-sickle cells ġew irrappurtati f'pazjenti bil-marda tas-sickle cells (ara sezzjoni 4.4).
English: Name and address of the manufacturer(s) of the biological active substance(s) Intas Pharmaceuticals Ltd.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: Neutrophil count
Maltese: Newtropenija konġenitali
English: In a small number of patients (< 10%), doses up to 1.0 MU (10 µg) /kg/day were required to achieve reversal of neutropenia.
Maltese: F'numru żgħir ta 'pazjenti(<10%), dożi sa 1.0 (10 µg)/kg/kuljum kienu meħtieġabiexikollhom taqlibta' newtropenja.
English: Malaise e
Maltese: Tnaqqis flaptite
English: NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Maltese: TAL-PRODOTT MEDIĊINALI Accofil 30 MU/0.5 ml soluzzjoni għall-injezzjoni/infużjoni filgrastim2.
English: Accofil contains no preservative.
Maltese: Accofil ma fih ebda preservattiv.
English: Fatiguea Mucosal inflammationa
Maltese: Kimoterapija ċitotossika stabbilita
English: Congenital neutropenia The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Maltese: Id-doża tal-bidu rakkomandata hi ta' 1.2 MU (12 µg/kg/jum bħala doża waħda jew f'dożi maqsumin.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2. tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Filgrastim for PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation Filgrastim should be given by subcutaneous injection.
Maltese: Filgrastim għall-mobilizzazzjoni tal-PBPC f'donaturi normali qabel trapjant alloġeneiku tal-PBPC Filgrastim għandu jingħata permezz ta' injezzjoni taħt il-ġilda.
English: Gammaglutamyl transferase increased Aspartate aminotransfera se increased
Maltese: Żieda f'gamma glutamyl transferase
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100
Maltese: Ilfrieħ tal-firien li ngħataw filgrastim waqt il-perjodi qabel it-twelid u t-treddigħ, urew dewmien fid differenzazzjoni esterna u dewmien fit-tkabbir (≥20 µg/kg/kuljum) u rata ta' sopravivenza kemxejn imnaqqsa (100 µg/kg/kuljum).
English: • a pre-filled syringe of Accofil;
Maltese: • siringa mimlija għal-lest b'Accofil;
English: if you experience kidney injury (glomerulonephritis).
Maltese: • Jekk ikollok ħsara fil-kliewi (glomerulonefrite).
English: Capillary leak syndrome
Maltese: Sindrome majelodisplastiku u Lewkimja majelojde kronika
English: Dose reductions of Filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Maltese: Ġie nnutat li tnaqqis fid-doża ta' Filgrastim jittardja jew iwaqqaf il-progressjoni tat-tkabbir tal-milsa f'pazjenti b'newtropenija kronika severa, u fi 3 % tal-pazjenti kienet meħtieġa splenektomija.
English: Respiratory , thoracic and mediastinal disorders
Maltese: Tromboċitopen ja Anemijae
English: Dizziness, Hypoaesthesia
Maltese: Uġigħ ta' rasa Sturdament, Ipoesteżija,
English: Haemoptysis Dyspnoea Cougha
Maltese: Newtropenija idjopatika jew ċikliku
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Maltese: Metaanaliżi ta' studji fuq trapjanti alloġeneiċi, li tinkludi r-riżultati ta' disa' provi prospettivi li fihom il-pazjenti ntgħażlu b'mod każwali, 8 studji retrospettivi u studju 1 ikkontrollat mill-każ, ma sabet l-ebda effett fuq ir-riskji ta' GvHD akuta, GvHD kronika jew mortalità relatata mal-kura bikrija.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-dejta fit-tabelli t'hawn taħt tiddeskrivi reazzjonijiet avversi rrappurtati minn provi kliniċi u rappurtaġġ spontanju.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini:http://www.ema.europa.eu
English: Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Maltese: Pazjenti b'indeboliment tal-kliewi Studji dwar filgrastim f'pazjenti b'indeboliment sever tal-funzjoni tal-kliewi jew tal-fwied juru li filgrastim juri profil farmakokinetiku u farmakodinamiku li hu simili għal dak li jiġi osservat f'individwi normali.