FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Maltese: Fi studju kliniku li sar fin-nisa wara l-menopawża u li huwa dokumentat li jbatu minn mard tal-qalb koronarju jew li qegħdin f'riskju ogħla li jkollhom xi problemi koronarji, raloxifene meta mqabbel ma' plaċebo, ma kellu ebda effett fuq l-inċidenza ta' attakk ta' qalb, ta' bżonn li tidħol l-isptar minħabba sindromu koronarju akut, ta' mortalità in ġenerali li tinkludi l-imwiet kardjovaskulari kollu jew ta' attakk ta' puplesija.
English: Package leaflet: Information for the user Optruma 60 mg film coated tablets raloxifene hydrochloride
Maltese: OPTRUMA 60 mg pilloli miksija b'rita raloxifene hydrochloride
English: Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
Maltese: l-insuffiċjenza tal-fwied - Il-farmakokinetika ta' doża waħda ta' raloxifene f'pazjenti b'ċirrożi u b'indeboliment moderat tal-fwied (Klassi A Child-Pugh) kien imqabbel ma' dak ta' individwi b'saħħithom.
English: Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Maltese: Optruma hija indikata għall-kura u l-prevenzjoni ta' l-osteoporożi fin-nisa wara l-menopawża.
English: Raloxifene is metabolised primarily in the liver.
Maltese: Raloxifene jiġi metaboliżżat primarjament fil-fwied.
English: The tablets are for oral use.
Maltese: Raloxifene jiġi assorbit malajr wara t-teħid orali.
English: • Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)
Maltese: • Formazzjoni ta' embolu f'xi arterja ( per eżempju puplesija, inkluż żieda fir-riskju li tmut minn puplesija)
English: Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Maltese: Il-konċentrazzjonijiet ta' raloxifene fil-plażma kienu bejn wieħed u ieħor 2.5 drabi ogħla mill-kontrolli u kienu jikkorrelaw mal-konċentrazzjonijiet tal-bilirubin. 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina
English: A similar increase in BMD was seen in the treatment population who received Optruma for up to 7 years.
Maltese: Żieda simili fil-BMD dehret fil-grupp tal-kura li rċevew Optruma għal perijodu ta' 7 snin.
English: Optruma was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Maltese: Optruma kienet assoċjata ma' tnaqqis fit-tmermir ta' l-għadam u ċaqlieq medju u pożittiv fil-bilanċ tal-calcium ta' 60 mg kuljum, dovut primarjament għat-tnaqqis fit-telf ta'
English: In the RUTH study, raloxifene did not affect the incidence of stroke, compared to placebo.
Maltese: Ma nstabux effetti avversi fuq il-funzjoni konjittiva.
English: Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Maltese: It-teħid konkomittanti ta' calcium carbonate jew ta' aluminium u magnesium hydroxide li jinstabu fil mediċini kontra l-aċidu ta' l-istonku, ma jaffetwax l-espożizzjoni sistemika ta' raloxifene.
English: These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Maltese: Optruma tista' biss tikkuralek jew tipprevenilek l-osteoporożi jekk tkompli tieħu lpilloli.
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Maltese: Kull pillola miksija b'rita għandha 60 mg ta' raloxifene hydrochloride, li hu ekwivalenti għal 56 mg ta' raloxifene.
English: At doses of 0.1 to 10 mg/kg/day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Maltese: Madankollu, jekk kont tieħu l-estroġenu fil-passat u kellek livelli għoljin ħafna ta' trigliċeridi, għandek tkellem lit tabib tiegħek qabel tieħu Optruma.
English: • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Maltese: • Il-ġilda madwar vina tkun ħamra u tuġa' (tromboflebite tal-vini superfiċjali)
English: PC: SN: NN:
Maltese: L-Inkjostru:
English: • Increased risk of blood clots in the legs (deep vein thrombosis)
Maltese: • Riskju ogħla ta' koaguli tad-demm fir-riġlejn ( trombożi tal-vini fil-fond)
English: The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Maltese: Ir-riskju ta' avveniment tromboemboliku kien l-akbar fl-ewwel erba' xhur tat-terapija.
English: It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Maltese: Jaġixxi bħala agonista fuq l-għadam u parzjalment fuq il-metaboliżmu tal-kolesterol (tnaqqis fil-kolesterol totali u dak LDL), iżda mhux fuq l-ipotalamus jew fuq it-tessuti ta' l-utru jew tas-sider.
English: For oral use Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: Superficial vein thrombophlebitis occurred in a frequency of 1 % in the raloxifene group and 0.6 % in the placebo group.
Maltese: 6% bl-Optruma u 7.1% bil-plaċebo).
English: Optruma is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Maltese: Optruma mhix effettiva biex tnaqqas il-vażodilatazzjoni (fwawar) u sintomi oħra tal-menopawsa assoċjati ma' defiċjenza ta' l-estroġenu.
English: Film coated tablet.
Maltese: raloxifene fil-plażma.
English: Meta-Analysis (2003)
Maltese: Meta-Analiżi (2003)
English: 10291 Prigorje Brdovečko Croatia
Maltese: 10291 Prigorje Brdovečko Il-Kroazja
English: Acute Grade II - IV GvHD
Maltese: Grad Akut II - IV GvHD
English: 4.9 Overdose
Maltese: .9 Doża eccessiva
English: • The active substance is filgrastim.
Maltese: • Is-sustanza attiva hija filgrastim.
English: Pseudogout (chondrocalcinosis pyrophosphate)
Maltese: Psewdogotta (chondrocalcinosis pyrophosphate)
English: 9/L to > 5.0 x 10
Maltese: 9/L sa > 5.0 x 10
English: Hospira Zagreb d.o.o.
Maltese: Hospira Zagreb d.o.o. Prudnička cesta 60
English: Пфайзер Люксембург САРЛ, Клон
Maltese: Пфайзер Люксембург САРЛ, Клон България Тел.:
English: 9/L and 10 x 10
Maltese: 9/L u 10 x 10
English: 4.8 Undesirable effects a.
Maltese: .8 Effetti mhux mixtieqa a.
English: Pulmonary adverse effects
Maltese: Effetti avversi pulmonari
English: Oedema peripheral e
Maltese: Edema periferali
English: Rare (≥ 1/10,000 to
Maltese: Rari (≥ 1/10,000 sa
English: Nivestim contains sorbitol (E420).
Maltese: Nivestim fih sorbitol (E420).
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: Issigurtà u l-effikaċja ta' filgrastim għadhom ma ġewx stabbiliti f' pazjenti b'Lewkimja Mijelojde Akuta de novo li għandhom < 55 sena u ċitoġenetiċi normali (t(8;21), t(15;17), u inv(16)).
English: Nivestim contains sorbitol
Maltese: Nivestim fih sorbitol
English: In clinical trials, 97% of patients who responded had a complete response at doses ≤ 24 µg/kg/day.
Maltese: Fi studji kliniċi, 97 % tal-pazjenti li rrispondu kellhom rispons komplet b'doża ta'  24 µg/kg/jum.
English: Sweets syndrome
Maltese: Sindromu ta' Sweets
English: • abnormal x-rays of the lungs (lung infiltration)
Maltese: • x-rays anormali tal-pulmun (infiltrazzjoni tal-pulmun)
English: Mobilisation
Maltese: Mobilizzazzjoni
English: Diarrhoea a,e
Maltese: Dijarea a, e
English: Tel: +34 91 490 99 00
Maltese: Tél: +34 91 490 99 00
English: Common (≥ 1/100 to
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: Nivestim contains sodium
Maltese: Nivestim fih sodium
English: *recombinant methionyl granulocyte colony-stimulating factor G-CSF produced in Escherichia coli (BL21) by recombinant DNA technology.
Maltese: * fattur ta' methionyl rikombinati li jistimola l-kolonji ta' granuloċiti (G-CSF) huwa magħmul minn Escherichia coli (BL21) b'teknoloġija rikombinanti tad-DNA.
English: Relative Risk (95% CI) of GvHD and TRM Following Treatment with GCSF after Bone Marrow Transplantation Publication
Maltese: Riskju Relattiv (95% CI) ta' GvHD u TRM Wara Kura b'G-CSF wara Trapjant tal-Mudullun
English: Date of first authorisation: 08 June 2010 Date of latest renewal: 27 May 2015
Maltese: Data tal-aħħar tiġdid: 27 ta' Mejju 2015
English: Oropharyngeal pain a,e
Maltese: Uġigħ orofarinġeali a, e
English: Deutschland Pfizer Pharma PFE GmbH Tel: + 49 (0)800 8535555
Maltese: PFE GmbH Tel: + 49 (0)800 8535555
English: Acetic acid glacial, sodium hydroxide, polysorbate 80, sorbitol (E420) and water for injections..
Maltese: Acetic acid glacial, sodium hydroxide, polysorbate 80, sorbitol (E420) u ilma għall-injezzjonijiet.
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Maltese: Vaskulite tal-ġilda Sindromu ta' Sweets (dermatożi newtrofilika akuta bid-deni)
English: Thrombocytopenia Anaemia e
Maltese: Tromboċitopenja Anemija
English: • bumpy skin rash (rash maculo-papular)
Maltese: • raxx tal-ġilda mqabbeż (raxx makulopapulari)
English: • pain and swelling of the joints, similar to gout (pseudogout)
Maltese: • uġigħ u nefħa tal-ġogi, simili għall-gotta (psewdogotta)
English: Vomiting a,e
Maltese: Rimettar a, e
English: This will take 15-30 minutes.
Maltese: Dan għandu jieħu 15-30 minuta.
English: This medicine contains 50 mg sorbitol in each ml.
Maltese: Din il-mediċina fiha 50 mg sorbitol f'kull mL.
English: European Retrospective Study (2004)
Maltese: Study (2006)
English: Excipient with known effect Each ml of solution contains 50 mg of sorbitol (E420) (see section 4.4).
Maltese: Kull mL ta' soluzzjoni fih 50 mg sorbitol (E420) (ara sezzjoni 4.4).
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Maltese: Anormalitajiet ċitoġeniċi transitorja ġew osservati f'donaturi normali wara l-użu ta' G-CSF.
English: When diluted in 5% glucose solution, Nivestim 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 ta' 5% glucose., Nivestim huwa kompatibbli mal-ħġieġ u varji tipi ta' plastik, fosthom il-PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: (Cyprus Branch) Τηλ: +357 22 817690
Maltese: Τηλ: +357 22 817690
English: • inflammation of the lung (bronchitis)
Maltese: • infjammazzjoni tal-pulmun (bronkite)
English: Acute myeloid leukaemia
Maltese: Lewkimja mijelojde akuta
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: Risk associated with increased doses of myelosuppressive medicinal products
Maltese: Riskju assoċjat ma' dożi miżjuda ta' prodotti mediċinali mijelosoppressivi
English: Nivestim should not be diluted with sodium chloride solutions.
Maltese: Nivestim m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: Osteoporosis
Maltese: Osteoporożi
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: Aġenti bħal melphalan, carmustine (BCNU) u carboplatin, meta jiġu amministrati għal perijodi twal qabel tentattivi ta' mobilizzazzjoni taċ-ċelluli proġenitriċi, jistgħu jirriżultaw f'numru inqas ta' ċelluli proġenitriċi.
English: • The other ingredients are acetic acid (glacial), sodium hydroxide, sorbitol E420, polysorbate 80, and water for injections.
Maltese: • Is-sustanzi l-oħra huma acetic acid (glacial), sodium hydroxide, sorbitol E420, polysorbate 80, u ilma għall-injezzjonijiet.
English: Glomerulonephritis Urine abnormality
Maltese: Glomerulonefrite Anormalità talawrina
English: Chronic GvHD
Maltese: GvHD Kroniku
English: Тел.
Maltese: Telqa
English: Reduce to 0.5 MU (5 µg)/kg/day
Maltese: MU (5 µg)/kg/jum
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Maltese: F'firien tqal, l-ebda tossiċità tal-omm jew fetali ma ġiet osservata f'dożi sa 575 µg/kg/jum.
English: Dizziness Hypoaesthesia Paraesthesia
Maltese: Sturdament Ipoesteżija Paresteżija
English: Use of Active UltraSafe Needle Guard for Nivestim 12 MU/0.2 ml solution for injection/infusion
Maltese: Meta tuża l-UltraSafe Needle Guard Attiva għal Nivstim 12 MU/0.2 mL soluzzjoni għall-injezzjoni/infużjoni
English: Each ml contains 60 million units [MU] (600 g) or 96 million units [MU] (960 g) of filgrastim.
Maltese: Kull mL fih 60 miljun unità [MU] (600 µg) jew 96 miljun unità [MU] (960 µg) ta' filgrastim.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessut konnettivi
English: Filgrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Maltese: Filgrastim huwa indikat għal kura ta' newtropenja persistenti (ANC ta' 1.0 x 10
English: The results of flow cytometric analysis of CD34
Maltese: Ir-riżultati ġejjin minn flow cytometric analysis tal-għadd taċ-ċelluli CD34
English: There are 1, 5, 8 or 10 syringes in each pack.
Maltese: Hemm siringa 1, 5, 8 jew 10 siringi f'kull pakkett.
English: Dizziness may occur following the administration of filgrastim (see section 4.8).
Maltese: Jista' jseħħ sturdament wara l-għoti ta' filgrastim (ara sezzjoni 4.8).
English: • swelling in the hands and feet (oedema peripheral)
Maltese: • nefħa fl-idejn u fis-saqajn (edema periferali)
English: 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: Nivestim is a biosimilar medicinal product.
Maltese: Nivestim hu prodott mediċinali bijosimili.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy:
Maltese: Filgrastim għall-mobilizzazzjoni ta' PBPC wara kimoterapija majelosuppressiva:
English: There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.8 and 5.1).
Maltese: Kien hemm rapporti ta' mard tal-graft kontra l-ospitu (G v HD) u fatalitajiet f'pazjenti li jirċievu GCSF wara trapjant tal-mudullun alloġeniku (ara s-sezzjonijiet 4.8 u 5.1).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Maltese: Filgrastim għandu jiġi dilwit f'20 mL ta' soluzzjoni ta' 5% glucose(ara sezzjoni 6.6).
English: Blood lactate dehydrogenase increased
Maltese: Tnaqqis fl-Aptit Żieda tal-lactate dehydrogenase fiddemm
English: Musculoskeletal pain c
Maltese: Uġigħ muskoluskeletriku
English: The recommendation of a minimum yields of ≥ 2.0 x 10
Maltese: Ir-rakkomandazzjoni ta' produzzjonijiet minimi ta' ≥ 2.0 x 10
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, każijiet pulmonari serji avversi (inkluż pulmonite interstizjali u ARDS), sindromu ta' tnixxija tal-kapillari, splenomegalija/tiċrit tal-milsa sever, trasformazzjoni għal sindromu mijelodisplastiku jew lewkimja f'pazjenti b'SCN, GvHD f'pazjenti li jirċievu trasferiment ta' mudullun alloġeniku jew trapjant taċ-ċelluli proġenituri tad-demm periferali u każijiet ta' kriżi ta' sickle cell f'pazjenti b'marda ta' sickle cell.
English: Based on reported data for another filgrastim product similar to the originator, 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-dejta rapportata għal prodott ieħor ta' filgrastim simili għall-oriġinatur, riżultati komparabbli flimkien ma' żieda fil-malformazzjonijiet fetali kienu osservati f'doża ta' 100 µg/kg/jum, doża tossika għall-ommijiet li kienet tikkorrispondi ma' esponiment sistemiku ta' madwar 50-90 darba l-esponimenti osservati f'pazjenti trattati bid-doża klinika ta' 5 µg/kg/jum.
English: Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Maltese: Filgrastim huwa indikat għall-mobilizzazzjoni taċ-ċelluli proġenitriċi tad-demm periferali (PBPCs).
English: In patients with severe chronic neutropenia (SCN)
Maltese: F'pazjenti b'newtropenja kronika u qawwija (SCN - severe chronic neutropenia)
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Maltese: Effetti pulmonari avversi, b'mod partikulari mard interstizjali tal-pulmun, ġew irrapportati wara lgħoti ta'G-CSF.
English: 9/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Maltese: 9/L) f'35 % tas-suġġeti li ġew studjati.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Maltese: Il-G-CSF uman huwa glikoproteina li tirregola l-produzzjoni u l-ħelsien ta' newtrofili funzjonali mill-mudullun.
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.6 mg/ml or 0.96 mg/ml dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) għal kull 0.6 mg/mL jew 0.96 mg/mL, jiġifieri essenzjalment hija ‘ħielsa mis-sodium'.
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' sindromu ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu kura sintomatika standard, li tista' tinkludi ħtieġa għal kura intensiva (ara sezzjoni 4.8).
English: Solution for injection/infusion.
Maltese: Soluzzjoni għall-injezzjoni/ infużjoni.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Maltese: Filgrastim jista' jingħata bħala injezzjoni taħt il-ġilda ta' kuljum jew bħala infużjoni minn ġol-vina ta' kuljum dilwita f'soluzzjoni ta' 5% glucose mogħtija fuq 30 minuta (ara sezzjoni 6.6).
English: Transient thrombocytopenia (platelets < 100 x 10
Maltese: Għadd taċ-ċelluli bojod ta' 100 x 10
English: Hepatomegaly Blood alkaline phosphatase increased
Maltese: Epatomegalija Żieda tal-alkaline phosphatase fid-demm
English: 1 pre-filled syringe with 0.5 ml 5 pre-filled syringes with 0.5 ml 8 pre-filled syringes with 0.5 ml 10 pre-filled syringes with 0.5 ml
Maltese: 1 siringa mimlija lesta b'0.5 mL. 5 siringi mimlijin lesti b'0.5 mL. 8 siringi mimlijin lesti b'0.5 mL. 10 siringi mimlijin lesti b'0.5 mL.
English: Transformation to leukaemia or myelodysplastic syndrome
Maltese: Trasformazzjoni f'lewkimja jew sindromu mijelodisplastiku
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Maltese: L-użu ta' filgrastim għall-mobilizzazzjoni ta' PBPCs f'donaturi normali qabel it-trapjant alloġeneiku ta' PBPC.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Maltese: Prekawzjonijiet speċjali f'reċipjenti ta' trapjant alloġenejiku ta' PBPCs mobilizzati b'filgrastim
English: Statistical analysis of the relationship between the number of CD34
Maltese: Studju statistiku tar-relazzjoni bejn in-numru ta' ċelluli CD34
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 g) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Maltese: Meta l-volum finali tal-injezzjoni huwa 20 mL, id-dożi kollha ta' filgrastim li fihom inqas minn 30 MU (300 µg) iridu jingħataw b' soluzzjoni ta' 0,2 mL ta' 200mg/mL (20%) albumina umana miżjuda.
English: Filgrastim for PBPC mobilisation when used alone:
Maltese: Filgrastim għall-mobilizzazzjoni ta' PBPC meta użat waħdu:
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Maltese: Għall-mobilizzazzjoni ta' PBPCs f'donaturi normali qabel trapjant alloġeniku ta' PBPC
English: EXP After dilution use within 24 hours.
Maltese: EXP Wara d-dilwazzjoni uża fi żmien 24 siegħa.
English: How do I administer my Nivestim?
Maltese: Kif għandi ninjetta Nivestim lili nnifsi?
English: Nivestim 12 MU/0.2 ml solution for injection/infusion Nivestim 30 MU/0.5 ml solution for injection/infusion Nivestim 48 MU/0.5 ml solution for injection/infusion filgrastim
Maltese: Nivestim 12 MU/ 0.2 mL soluzzjoni għall-injezzjoni/ infużjoni Nivestim 30 MU/ 0.5 mL soluzzjoni għall-injezzjoni/ infużjoni Nivestim 48 MU/ 0.5 mL soluzzjoni għall-injezzjoni/ infużjoni filgrastim
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 aktar ġew osservati f'inqas minn 5 % tal-pazjenti bilkanċer li ngħataw filgrastim b'dożi akbar minn 0.3 MU/kg/jum (3 µg/kg/jum).
English: Remove the Nivestim syringe from the fridge and allow it to reach room temperature (approximately 25 C).
Maltese: Oħroġ is-siringa ta' Nivestim minn ġol-friġġ u ħallieha tilħaq it-temperatura ambjentali talkamra (madwar 25 C).
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline were subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Maltese: Subset ta' madwar 12 % tal-pazjenti li fil-bidu kellhom parametri ċitoġenetiċi normali, sussegwentement instabu li kellhom abnormalitajiet, fosthom monosomy 7, f'analiżi li ġew ripetuti perjodikament.
English: 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 mwiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeniku (allogeneic) tal-mudullun (ara sezzjonijiet 4.4 u 5.1).
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal fil-każ ta' fatturi ta' tkabbir ematopojetiċi oħra, G-CSF wera proprjetajiet stimolanti in vitro fuq ċelluli endoteljali umani.