FrancophonIA/ELRC3.0 huggingface dataset:
English: Solution for injection in a pack size of one single use pre-filled syringe (0.64 mL) and one on-body injector (Onpro kit).
Maltese: Soluzzjoni għall-injezzjoni f'daqs tal-pakkett ta' siringa waħda mimlija għal-lest għall-użu ta' darba (0.64 mL) u injettatur li jeħel mal-ġisem wieħed (Onpro kit).
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Maltese: Reazzjonijiet tat-tip ta' sensittività eċċessiva, inkluż raxx tal-ġilda, urtikarja, anġjoedima, qtugħ ta' nifs, eritema, fwawar u pressjoni baxxa seħħew mal-ewwel trattament jew ma' trattament sussegwenti b'pegfilgrastim (mhux komuni [≥ 1/1,000 sa < 1/100]).
English: Latex may be transferred to your skin.
Maltese: Latex jista' jiġi trasferit għall-ġilda tiegħek.
English: Sickle cell anaemia
Maltese: Tromboċitopenija u anemija
English: Profile of median pegfilgrastim serum concentration and Absolute Neutrophil Count (ANC) in chemotherapy treated patients after a single 6 mg injection
Maltese: Profil tal-konċentrazzjoni medjana fis-serum ta' pegfilgrastim u l-Għadd Assolut ta' Newtrofili (ANC - Absolute Neutrophil Count) f'pazjenti ttrattati b'kimoterapija wara injezzjoni waħda ta' 6 mg
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001).
Maltese: Linċidenza tan-newtropenija bid-deni kienet aktar baxxa f'pazjenti randomised biex jirċievu pegfilgrastim meta mqabbla ma' dawk li rċevew plaċebo (1% versus 17%, p < 0.001).
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti kienu uġigħ fl-għadam (komuni ħafna [≥ 1/10]) u uġigħ muskolu-skeletriku (komuni [≥ 1/100 sa < 1/10]).
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Iċċekkja d-data ta' skadenza fuq it-tikketta tas-siringa mimlija għal-lest (EXP).
English: - Oxygen rich environments, such as hyperbaric chambers (a transparent chamber with an increase in atmospheric pressure).
Maltese: - Ambjent b'ħafna ossiġnu, bħal kmamar iperbariċi (kamra trasparenti b'żieda fil-pressjoni atmosferika).
English: Neulasta 6 mg injection pegfilgrastim
Maltese: Neulasta 6 mg injezzjoni pegfilgrastim
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
Maltese: Fi studju wieħed (n = 157), fejn intużat doża fissa ta' 6 mg ta' pegfilgrastim id-dewmien medju ta' newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kien ta' 1.8 ijiem meta mqabbel ma' 1.6 ijiem fil-grupp ta' filgrastim (differenza ta' 0.23 jum, CI ta' 95% -0.
English: Sickle cell crisis2; Splenomegaly Splenic rupture2
Maltese: Kriżi taċ-ċellula forma ta' minġel2;
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Neulasta with any other medicinal products.
Maltese: Ma sarux studji speċifiċi dwar l-interazzjonijiet jew il-metaboliżmu, madankollu, provi kliniċi ma indikawx interazzjoni ta' Neulasta ma' prodotti mediċinali oħra.
English: OTHER
Maltese: A
English: Sodium acetate* Sorbitol (E420) Polysorbate 20
Maltese: Sorbitol (E420)
English: G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: G-CSF jista' jippromovi t-tkabbir in vitro ta' ċelluli majelojdi, inklużi ċelluli malinni, u effetti simili jistgħu jidhru wkoll fuq xi ċelluli mhux majelojdi in vitro.
English: 9) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Maltese: 9) fi tfal iżgħar b'età ta' 0-5 snin (8.9 ijiem) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (6 ijiem u 3.7 ijiem, rispettivament) u ma' adulti.
English: Thrombocytopenia1 Leukocytosis
Maltese: Uġigħ fis-sit talinjezzjoni1
English: Neulasta 6 mg injection pegfilgrastim SC
Maltese: Neulasta 6 mg injezzjoni pegfilgrastim SC
English: Syringe label Syringe barrel Syringe safety guard
Maltese: Tikketta tas-siringa Kanna tas-siringa użata
English: Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 7%, 95% CI of -19%, 5%).
Maltese: 15, 0.63). Matul l-istudju kollu, ir-rata ta' newtropenija bid-deni kienet ta' 13% tal-pazjenti ttrattati b'pegfilgrastim mqabbla ma' 20% tal-pazjenti ttrattati b'filgrastim (differenza ta' 7%, CI ta' 95% ta' -19%, 5%).
English: Clean the injection site with an alcohol wipe.
Maltese: Naddaf is-sit ta' injezzjoni b' alcohol wipe.
English: Anaphylaxis
Maltese: Allerġiji
English: Nausea1
Maltese: Tqalligħ1
English: Tabulated summary of adverse reactions
Maltese: Sommarju ta' reazzjonijiet avversi miġbura f'tabella
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to 7 days, and a 30-40% incidence of febrile neutropenia.
Maltese: Fin-nuqqas ta' appoġġ ta' fattur tat-tkabbir, ġie rrappurtat li dan il-kors ta' dożaġġ iwassal għal newtropenija ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30-40% ta' newtropenija bid-deni.
English: Leukocytosis
Maltese: Lewkoċitosi
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see section 4.8).
Maltese: Pazjenti b'każ reċenti ta' infiltrati fil-pulmun jew pulmonite jista' jkollhom riskju ogħla (ara sezzjoni 4.8).
English: In a second study (n = 310), which used a weightadjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
Maltese: Fi studju ieħor (n = 310), fejn intużat doża maħduma skont il-piż (100 mcg/kg), id-dewmien medju tan-newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 ijiem, imqabbel ma' 1.8 ijiem fil-grupp ta' filgrastim (differenza ta' 0.03 ijiem, CI ta' 95% -0.36, 0.30).
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 along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Bidu ta' sinjali pulmonari bħal sogħla, deni u qtugħ ta' nifs flimkien ma' sinjali radjuloġiċi ta' infiltrati fil-pulmun, u deterjorazzjoni tal-funzjoni tal-pulmun flimkien ma' żieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-Sindrome ta' Tbatija Respiratorja Akuta (ARDS - Acute Respiratory Distress Syndrome).
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħal b'kull proteina terapewtika oħra, hemm potenzjal ta' immunoġeniċità.
English: Loss of response to pegfilgrastim
Maltese: Telf ta' rispons għal pegfilgrastim
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Maltese: Pazjenti li jiżviluppaw sintomi ta' sindrome ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu trattament simtomatiku standard, li jista' jinkludi ħtieġa ta' kura intensiva (ara sezzjoni 4.8).
English: Pegfilgrastim Conc.
Maltese: Konċ ta' Pegfilgrastim ANC
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Maltese: • ħsara lill-filtri ċkejkna ġewwa l-kliewi tiegħek (glomerulonefrite).
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicine.
Maltese: Din iż-żieda taċ-ċelluli bojod hija temporanja, tipikament osservata 24 sa 48 siegħa wara l-għoti u hija konsistenti mal-effetti farmakodinamiċi ta' din il-mediċina.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intoleranza għal fructose m'għandhomx jieħdu din il-mediċina.
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Maltese: Konsistenti mal-effetti kliniċi u l-potenzjal għal lewkoċitosi, għadd ta' WBC għandu jsir f'intervalli regolari waqt it-terapija.
English: Tel: +386 (0)1 585 1767
Maltese: AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767
English: SYRINGE LABEL
Maltese: Tikketta tas-siringa
English: Neulasta is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Maltese: Neulasta huwa soluzzjoni ċara u bla kulur, għall-injezzjoni ġo siringa mimlija għal-lest (6 mg/0.6 mL).
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Maltese: II-IV ta' riskju għoli li kienu qed jirċievu 100 mcg/kg pegfilgrastim wara li temmew doxorubicin/docetaxel (ara sezzjonijiet 4.8 u 5.1).
English: • if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
Maltese: • jekk inti reċentement kellek infezzjoni serja tal-pulmun (pnewmonja), fluwidu fil-pulmuni (edima pulmonari) , infjammazzjoni tal-pulmun (marda tal-interstizju tal-pulmun ), jew x-ray mhux normali tas-sider (infiltrazzjoni fil-pulmun).
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: Uġigħ fl-għadam Uġigħ muskoluskeletriku (majalġja, artralġja, uġigħ flestremitajiet, uġigħ fid-dahar, uġigħ muskolu-skeletriku, uġigħ fl-għonq)
English: ANC
Maltese: Inc.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Maltese: 2 Din ir-reazzjoni avversa kienet identifikata permezz ta' sorveljanza ta' wara t-tqegħid fis-suq iżda ma kienetx osservatia fi provi kliniċi randomised u kkontrollati f'adulti.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim f'0.6 mL (10 mg/mL) ta' soluzzjoni għallinjezzjoni.
English: In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Maltese: F'żewġ studji randomised, double-blind, ewlenin, f'pazjenti b'kanċer tas-sider ta' riskju għoli ta' stadju II-IV li kienu qed jingħataw kimoterapija majelosoppressiva li tikkonsisti minn doxorubicin u docetaxel, l-użu ta' pegfilgrastim, bħala doża waħda f'kull ċiklu, naqqset id-dewmien tannewtropenija u l-inċidenza ta' newtropenija bid-deni b'mod simili għal dak osservat bl-għoti ta' kuljum ta' filgrastim (medjan ta' 11-il għoti kuljum).
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-data fit-tabella t'hawn taħt tiddeskrivi reazzjonijiet avversi rrappurtati minn provi kliniċi u minn rappurtar spontanju.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimula l-kolonja ta' granuloċiti (G-CSF - granulocyte colony stimulating factor) huwa glikoproteina li tirregola il-produzzjoni u r-reħa ta' newtrofili mill-mudullun.
English: Get emergency medical help right away.
Maltese: Ikseb għajnuna medika ta' emerġenza minnufih.
English: Cutaneous vasculitis
Maltese: Post fejn tpoġġi sswaba
English: Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Maltese: Pegfilgrastim huwa forma ta' filgrastim li jdum aktar fil-ġisem minħabba li t-tneħħija mill-kliewi hija mnaqqsa.
English: • rash, itchy red raised bumps (contact dermatitis/local skin reactions) have been seen with the on-body injector.
Maltese: • raxx, ponot imqabżin ħomor u bil-ħakk (dermatite tal-kuntatt/reazzjonijiet lokali tal-ġilda) kienu osservati bl-injettatur li jeħel mal-ġisem.
English: Rare side effects (may affect up to 1 in 1000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa wieħed minn kull 1,000 persuna):
English: Marketing Authorisation Holder Amgen Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Amgen Europe B.V.
English: Application site reactions (including events such as haemorrhage, pain, discomfort, bruise, and erythaema) have been reported with the use of the on-body injector.
Maltese: Reazzjonijiet fis-sit tal-applikazzjoni (inklużi avvenimenti bħal emorraġija, uġigħ, skonfort, tbenġil, u eritema) kienu irrappurtati bl-użu tal-injettatur li jeħel mal-ġisem.
English: Upper thigh
Maltese: Aqbad hawn
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Maltese: Reazzjonijiet allerġiċi serji, inkluż anafilassi jistgħu jseħħu f'pazjenti li jirċievu pegfilgrastim (mhux komuni) (ara sezzjoni 4.4).
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Maltese: Data klinika limitata tissuġġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenija severa f'pazjenti li reġgħet qabdithom lewkimja majelojde akuta (AML - acute myeloid leukaemia) mill-ġdid, huwa komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: (ng/ml)
Maltese: Puh/Tel:
English: If leukocyte counts exceed 50 x 10
Maltese: Jekk wara t-tnaqqis mistenni, l-għadd ta' lewkoċiti jaqbeż 50 x 10
English: • if you have an allergy to latex.
Maltese: • jekk inti għandek allerġija għal-latex.
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Maltese: Tnaqqis fid-dewmien tan-newtropenija u fl-inċidenza ta' newtropenija bid-deni f'pazjenti adulti ttrattati b'kimoterapija ċitotossika għal tumur malinn (bl-eċċezzjoni ta' lewkimja majelojde kronika u sindromi mijelodisplastiċi).
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Maltese: Jappartjeni għal grupp ta' proteini msejħa ċitokini, u hija simili ħafna għal proteina naturali (fattur li jistimula l-kolonja ta' granuloċiti) magħmula mill-ġisem tiegħek stess.
English: How do I prepare my Neulasta injection?
Maltese: Kif nipprepara l-injezzjoni ta' Neulasta?
English: Headache
Maltese: Ftakar
English: Each pre-filled syringe contains 0.64 mL of solution that delivers 6 mg of pegfilgrastim (10 mg/mL) to be used with the on-body injector.
Maltese: Kull siringa mimlija għal-lest fiha 0.64 mL ta' soluzzjoni li tagħti 6 mg ta' pegfilgrastim (10 mg/mL) għall-użu flimkien mal-injettatur li jeħel mal-ġisem.
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastiku naturali niexef (mnissel mill-latex) (ara sezzjoni 4.4).
English: Acute Respiratory Distress
Maltese: Sindrome ta' Distress
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Glomerulonefrite ġiet irrappurtata f'pazjenti li jkunu qed jirċievu filgrastim u pegfilgrastim.
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Barra dan kienet osservata inċidenza ogħla ta' newtropenija bid-deni fi tfal iżgħar b'età ta' 0-5 snin (75%) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (70% u 33%, rispettivament) u ma' adulti (ara sezzjonijiet 4.8 u 5.2).
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Maltese: Studji fil-frien indikaw li l-ħila riproduttiva, fertilità, ċikl oestrous, ġranet bejn it-tqabbil u l-kopulazzjoni, u s-sopravivenza fil-ġuf ma ġewx affettwati minn Pegfilgrastim mogħti taħt il-ġilda.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Maltese: • Sindrome ta' Stevens-Johnson, li tista' tidher bħala rqajja' ċirkulari ħomor li jixbhu l-bersalli, ħafna drabi b'infafet ċentrali fuq it-torso, tqaxxir tal-ġilda, ulċeri fil-ħalq, il-griżmejn, limnieħer, il-ġenitali u l-għajnejn u li tista' tibda b'deni u sintomi li jixbhu l-influwenza.
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Kienu rrappurtati reazzjonijiet avversi mhux komuni relatati mal-pulmun, fosthom pulmonite talinterstizju, edima fil-pulmun, infiltrati fil-pulmun u fibrożi fil-pulmun.
English: Three reported cases show a causal relationship between the adverse drug reaction (ADR) StevensJohnson syndrome and pegfilgrastim.
Maltese: Tliet każijiet irrappurtati juru relazzjoni każwali bejn ir-reazzjoni avversa għall-mediċina (ADR) issindrome ta' Stevens-Johnson u pegfilgrastim.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Reazzjonijiet avversi relatati mal-pulmun, b'mod partikulari pulmonite tal-interstizju, ġew irrappurtati wara l-għoti ta' G-CSF.
English: • a pre-filled syringe of Neulasta; and
Maltese: • siringa mimlija għal-lest b'Neulasta; u
English: Apply a plaster if needed.
Maltese: Applika stikka jekk hemm bzonn.
English: Syringe label Used syringe barrel
Maltese: Molla protettiva tallabra użata
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Maltese: • Iz-zaqq, ħlief 5 cm (2-inch) mad-dawra taż-żokra.
English: The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%).
Maltese: Ir-rata totali ta' newtropenija bid-deni kienet ta' 9% tal-pazjenti ttrattati b'pegfilgrastim u 18% tal-pazjenti ttrattati b'filgrastim (differenza ta' 9%, CI ta' 95% ta' -16.
English: • if you have an allergy to acrylic adhesives.
Maltese: • jekk għandek allerġija għal kolla akrilika.
English: There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Maltese: M'hemmx informazzjoni suffiċjenti dwar l-eliminazzjoni ta' pegfilgrastim/metaboliti fil-ħalib tassider tal-bniedem, u riskju għat-trabi ta' twelid/trabi ma jistax jiġi eskluż.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving Neulasta following cytotoxic chemotherapy.
Maltese: Żidiet ħfief sa moderati li jerġgħu lura għan-normal, u mingħajr effetti kliniċi assoċjati, fil-uric acid u f'alkaline phosphatase kienu osservati b'mod mhux komuni; żidiet ħfief sa moderati li jerġgħu lura għan-normal, u mingħajr effetti kliniċi assoċjati, f'lactate dehydrogenase, kienu osservati b'mod mhux komuni f'pazjenti li ngħataw Neulasta wara kimoterapija ċitotossika.
English: Abdomen
Maltese: Amgen
English: The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' Neulasta ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' majelosoppressjoni ittardjata eż. nitrosoureas.
English: Tel.: +48 22 581 3000
Maltese: Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000
English: • swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: • nefħa jew tpaħpiħ, li jistgħu jkunu assoċjati ma' mogħdija inqas frekwenti tal-awrina, diffikultà biex tieħu n-nifs, nefħa addominali u tħossok mimli, u sensazzjoni ġenerali ta' għeja.
English: Hypersensitivity reactions;
Maltese: Reazzjonijiet ta' sensittività eċċessiva;
English: Contact dermatitis and local skin reactions such as rash, pruritus, and urticaria have been reported with the use of the on-body injector, possibly indicating a hypersensitivity reaction to the adhesive.
Maltese: Dermatite tal-kuntatt u reazzjonijiet lokali tal-ġilda bħal raxx, ħakk, u urtikarja kienu irrappurtati blużu tal-injettatur li jeħel mal-ġisem, possibbilment jindikaw reazzjoni ta' sensittività eċċessiva għallkolla.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: In an open-label, single dose study (n = 31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Maltese: (n = 31), diversi stadji ta' indeboliment tal-kliewi, inkluż marda tal-kliewi tal-aħħar stadju, ma kellhom l-ebda impatt fuq il-farmakokinetika ta' pegfilgrastim.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Maltese: II, randomised u double-blind f'pazjenti li kienu qed jirċievu kimoterapija għal lewkimja majelojde akuta de novo, pegfilgrastim (doża waħda ta' 6 mg) kien imqabbel ma' filgrastim, mogħtija waqt kimoterapija ta' induzzjoni.
English: Step 2: Monitor Dose Delivery
Maltese: It-tieni Pass: Immonitorja l-Għoti tad-Doża
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m every 3 weeks for
Maltese: Fi studju double-blind, ikkontrollat bil-plaċebo, f'pazjenti b'kanċer tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' kors ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20% (docetaxel 100 mg/m kull 3 ġimgħat għal 4 ċikli).
English: • inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Maltese: • infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall ġisem), ara sezzjoni 2.