FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 1: Profile of median serum concentration of lipegfilgrastim and median ANC in chemotherapy-treated patients after a single 6 mg injection of lipegfilgrastim
Maltese: Figura 1: Profil tal-medjan tal-konċentrazzjoni ta' lipegfilgrastim fis-serum u medjan tal-ANC f'pazjenti ttrattati bil-kimoterapija wara injezzjoni waħda ta' 6 mg ta' lipegfilgrastim
English: In 3 studies (XM22-01, XM22-05, XM22-06) in healthy volunteers, the maximum blood concentration was reached after a median of 30 to 36 hours and the average terminal half-life ranged from approximately 32 to 62 hours after a single subcutaneous injection of 6 mg lipegfilgrastim.
Maltese: Fi 3 studji (XM22-01, XM22-05, XM22-06) fuq voluntiera b'saħħithom, il-konċentrazzjoni massima fid-demm intlaħqet wara medjan ta' 30 sa 36 siegħa u l-medja tal-half-life terminali kienet tvarja minn madwar 32 sa 62 siegħa wara injezzjoni waħda taħt il-ġilda ta' 6 mg ta' lipegfilgrastim.
English: Vascular adverse reactions
Maltese: Reazzjonijiet avversi vaskulari
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA14
Maltese: Immunostimulanti, fatturi li jistimulaw il-kolonji, Kodiċi ATC:
English: Polysorbate 20
Maltese: Sorbitol (E420) Polysorbate 20
English: Study days, injection of lipegfilgrastim at day 0
Maltese: Jiem ta' studju, injezzjoni ta' lipegfilgrastim f'jum 0
English: It belongs to a group of proteins called cytokines and is 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 għal proteina naturali (fattur tal-istimulazzjoni tal-kolonji talgranuloċiti [G-CSF]) magħmul minn ġismek stess.
English: Patients were randomised 1:1 to receive 6 mg lipegfilgrastim or 6 mg pegfilgrastim.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu 6 mg ta' lipegfilgrastim jew 6 mg ta' pegfilgrastim.
English: Breast-feeding should be discontinued during treatment with Lonquex.
Maltese: It-treddigћ gћandu jitwaqqaf waqt it-trattament b'Lonquex.
English: The incidence of FN varied according to age (from 14.3 % to 71.4 %), with the highest frequency in the oldest age group.
Maltese: (minn 14.3% sa 71.4%), bl-ogħla frekwenza tkun fil-grupp bl-ikbar età.
English: Renal and urinary disorders - Glomerulonephritis (see section 4.4)
Maltese: Disturbi fil-kliewi u fis-sistema urinarja - Glomerulonefrite (ara sezzjoni 4.4) Popolazzjoni pedjatrika
English: Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called Escherichia coli.
Maltese: Lipegfilgrastim hu proteina modifikata taħdem fit-tul magħmula permezz ta' bijoteknoloġija f'batterji msejħa Escherichia coli.
English: There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women.
Maltese: Hemm data limitata ħafna (inqas min 300 riżultat ta' tqala) dwar l-użu ta' lipegfilgrastim f'nisa tqal.
English: Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8).
Maltese: Lipegfilgrastim jista' jikkawża wkoll tromboċitopenija riversibbli (ara sezzjoni 4.8).
English: Date of first authorisation: 25 July 2013.
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' Lulju, 2013.
English: Lonquex does not contain any preservative.
Maltese: Lonquex ma fih l-ebda preservattiv.
English: Δ LS mean (least square mean difference lipegfilgrastim - placebo), CI and p-value out of multivariate Poisson regression analysis
Maltese: Δ medja ta' LS (differenza tal-least square mean lipegfilgrastim - plaċebo) CI u valur p minn analiżi ta' rigressjoni ta' Poisson multivarjata
English: Hypokalaemia has been reported (see section 4.4).
Maltese: Ipokalemija ġiet irrappurtata (ara sezzjoni 4.4).
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8).
Maltese: Sindromu ta' tnixxija kapillari, li jista' jkun ta' periklu għall-ħajja jekk it-trattament idum ma jingħata, ġie rrappurtat l-aktar f'pazjenti bil-kanċer li jkunu qed jirċievu kimoterapija wara l-għoti ta' G-CSF jew derivattivi (ara sezzjoni 4.4 u sezzjoni 4.8).
English: Therefore, lipegfilgrastim is not likely to affect metabolism via human cytochrome P450 enzymes.
Maltese: Għalhekk, lipegfilgrastim x'aktarx li mhux se jaffettwa l-metaboliżmu permezz ta' enzimi taċ-ċitokrom P450 tal-bniedem.
English: There is no evidence that lipegfilgrastim is teratogenic.
Maltese: M'hemm l-ebda evidenza li lipegfilgrastim hu teratoġeniku.
English: • The other ingredients (excipients) are glacial acetic acid, sodium hydroxide , sorbitol (E420), polysorbate 20 and water for injections.
Maltese: - Is-sustanzi l-oħra (eċċipjenti) huma glacial acetic acid, sodium hydroxide, sorbitol (E420),
English: Lipegfilgrastim is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes.
Maltese: Lipegfilgrastim jiġi internalizzat min-newtrofili (proċess mhux lineari), imbagħad jiġi ddegradat fiċ-ċelluli minn enzimi proteolitiċi endoġeni.
English: Δ LS mean
Maltese: Δ medja ta' LS
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim (see section 4.8).
Maltese: Reazzjonijiet pulmonari avversi, b'mod partikulari pnewmonja interstizjali, ġew irrappurtati wara lgħoti ta' lipegfilgrastim (ara sezzjoni 4.8).
English: There is evidence that filgrastim and pegfilgrastim may be transported at low levels over the placenta in rats, although no information is available for lipegfilgrastim.
Maltese: Hemm evidenza li filgrastim u pegfilgrastim jistgħu jiġu ttrasportati f'livelli baxxi fuq il-plaċenta fil-firien, għalkemm m'hemm l-ebda informazzjoni disponibbli għal lipegfilgrastim.
English: Solution for injection in pre-filled syringe 1 pre-filled syringe of 0.6 ml solution 1 pre-filled syringe of 0.6 ml solution with safety device
Maltese: 1 siringa mimlija għal-lest ta' 0.6 ml ta' soluzzjoni 1 siringa mimlija għal-lest ta' 0.6 ml ta' soluzzjoni b'tagħmir tas-sigurtà
English: UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
Maltese: Eesti filiaal Tel: +372 661 0801
English: When the main study was finalised, the incidence of death was 7.2 % (placebo) and 12.5 % (6 mg lipegfilgrastim) although after the 360-day follow-up period the overall incidence of death was similar between placebo and lipegfilgrastim (44.8 % and 44.0 %; safety population).
Maltese: Ir-riżultati tal-istudju huma ppreżentati f'tabella 3. Meta l-istudju ewlieni ġie ffinalizzat, l-inċidenza ta' mewt kienet ta' 7.2 % (plaċebo) u 12.5% (6 mg ta' lipegfilgrastim) għalkemm wara l-perjodu ta' 360 jum ta' follow-up, l-inċidenza globali ta' mewt kienet simili bejn il-plaċebo u lipegfilgrastim (44.8 % u 44.0 %; popolazzjoni tassigurtà).
English: In a phase 1 study (see section 5.1), using a 10 mg/ml solution for subcutaneous injection specifically developed for the paediatric studies, the mean maximum blood concentrations (Cmax) were 243 ng/ml in the 2 to <6-year group, 255 ng/ml in the 6 to <12-year group and 224 ng/ml in the 12 to <18-year group after a single subcutaneous injection of 100 μg/kg (maximum 6 mg) lipegfilgrastim with the first cycle of chemotherapy.
Maltese: kienu 243 ng/ml fil-grupp ta' sentejn sa <6 snin, 255 ng/ml fil-grupp ta' 6 snin sa <12-il sena u 224 ng/ml fil-grupp ta' 12-il sena sa <18-il sena wara injezzjoni waħda taħt il-ġilda ta' 100 μg/kg (massimu 6 mg) ta' lipegfilgrastim mal-ewwel ċiklu ta' kimoterapija.
English: Drug-specific antibodies emerging after start of treatment were detected in 0.86 % of the subjects receiving lipegfilgrastim, in 1.06 % of the subjects receiving pegfilgrastim and in 1.65 % of the subjects receiving placebo.
Maltese: L-antikorpi speċifiċi għall-mediċina li żviluppaw wara l-bidu tat-trattament kienu osservati f'0.86% tal-individwi li kienu qed jirċievu lipegfilgrastim, f'1.06% tal-individwi li kienu qed jirċievu pegfilgrastim u f'1.65% tal-individwi li kienu qed jirċievu plaċebo.
English: Certain adverse reactions have not yet been observed with lipegfilgrastim, but are generally accepted as being attributable to G-CSF and derivatives:
Maltese: Ċerti reazzjonijiet avversi għadhom ma ġewx osservati s'issa b'lipegfilgrastim, iżda huma ġeneralment aċċettati bħala li huma attribwibbli għal G-CSF u derivati:
English: The second pivotal (phase III) clinical study XM22-04 was a placebo-controlled study in 375 patients with non-small cell lung cancer receiving up to 4 cycles of chemotherapy consisting of cisplatin and etoposide.
Maltese: It-tieni studju kliniku, importanti ħafna (fażi III) XM22-04 kien studju bi plaċebo bħala kontroll li sar fuq 375 pazjent b'kanċer tal-pulmun ta' ċelluli mhux żgħar li kienu qed jirċievu sa 4 ċikli ta'
English: The use of three different chemotherapy regimens, with varying myelosuppressive effects and age distributions, complicated the comparison of efficacy across age groups (see section 4.2).
Maltese: kimoterapija differenti, b'effetti majelosuppressivi u b'distribuzzjonijiet ta' età li jvarjaw, ikkomplika t-tqabbil tal-effikaċja fil-gruppi ta' età (ara sezzjoni 4.2).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull siringa mimlija għal-lest, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: *See section “Description of selected adverse reactions” below Description of selected adverse reactions
Maltese: *Ara s-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim (see section 4.8) and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives (see section 4.8).
Maltese: Każijiet ġeneralment asintomatiċi ta' splenomegalija ġew irrappurtati wara l-għoti ta' lipegfilgrastim (ara sezzjoni 4.8) u każijiet mhux frekwenti ta' ftuq tal-milsa, li jinkludu każijiet fatali, ġew irrappurtati wara l-għoti ta' G-CSF jew derivati (ara sezzjoni 4.8).
English: These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see section 4.4).
Maltese: infiltrati pulmonari, fibrożi pulmonari, waqfien tan-nifs jew ARDS (ara sezzjoni 4.4).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet's syndrome) - Cutaneous vasculitis
Maltese: Dermatosi newtrofilika akuta bid-deni (sindromu ta' Sweet)
English: Odds ratio (lipegfilgrastim / placebo), CI and p-value out of multivariate logistic regression analysis
Maltese: Il-proporzjon tal-odds (lipegfilgrastim/plaċebo), CI u l-valur p li jirriżulta minn analiżi ta' rigressjoni loġistika multivarjata
English: The adverse reactions listed below in table 1 are classified according to system organ class.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt f'tabella 1 huma kklassifikati skont is-sistema tal-klassifika tal-organi.
English: A post-authorisation safety study XM22-ONC-40041 was conducted to collect data of disease progression and mortality in patients with advanced squamous or non-squamous cell lung cancer receiving lipegfilgrastim in addition to the platinum-based chemotherapy.
Maltese: Sar studju dwar is-sigurtà wara l-awtorizzazzjoni, XM22-ONC-40041, biex tinġabar data dwar il progressjoni tal-marda u l-mortalità f'pazjenti b'kanċer avvanzat tal-pulmun taċ-ċellula skwamuża jew mhux skwamuża li jirċievu lipegfilgrastim flimkien ma' kimoterapija bbażata fuq platinum.
English: A trend towards a decrease in lipegfilgrastim exposure was observed with increase in weight.
Maltese: Ġiet osservata tendenza lejn tnaqqis fl-esponiment għal lipegfilgrastim ma' żieda fi piż.
English: The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %.
Maltese: Il-medja tal-piż molekulari hi ta' madwar 39 kDa, li minnhom, il-moijetà talproteina tikkostitwixxi madwar 48 %.
English: In a study (XM22-04) in patients with non-small cell lung cancer receiving chemotherapy consisting of cisplatin and etoposide, the mean maximum blood concentration of 317 ng/ml was reached after a median tmax of 24 hours and the mean terminal half-life was approximately 28 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
Maltese: Fi studju (XM22-04) li sar fuq pazjenti b'kanċer tal-pulmun ta' ċelluli mhux żgħar li kienu qed jirċievu kimoterapija li tikkonsisti minn cisplatin u etoposide, il-medja tal-konċentrazzjoni massima fid-demm ta' 317 ng/ml intlaħqet wara tmax medjan ta' 24 siegħa u l-medja tal-half-life terminali kienet ta' madwar 28 siegħa wara injezzjoni waħda taħt il-ġilda ta' 6 mg ta' lipegfilgrastim matul l-ewwel ċiklu ta' kimoterapija.
English: Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Maltese: Glomerulonefrite ġiet irrappurtata f'pazjenti li jkunu qed jirċievu filgrastim, lenograstim jew pegfilgrastim.
English: If WBC counts exceed 50 x 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately.
Maltese: Jekk l-għadd tal-WBC jaqbeż 50 x 109/l wara l-għadd minimu mistenni, lipegfilgrastim għandu jitwaqqaf immedjatament.
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 kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu trattament sintomatiku standard, li jista' jinkludi ħtieġa għal kura intensiva (ara sezzjoni 4.8).
English: ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
Maltese: ITT = Popolazzjoni b'intenzjoni li tiġi ttrattata (pazjenti kollha li ntgħażlu b'mod każwali) SD = devjazzjoni standard d = jiem
English: Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs tal-milsa għandu jiġi mmonitorjat bir-reqqa (eż. eżami kliniku, ultrasound).
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu dan il-prodott mediċinali.
English: This medicinal product contains sorbitol.
Maltese: Dan il-prodott mediċinali fih sorbitol.
English: Leukocytosis may occur (see section 4.8).
Maltese: Ipokalemija tista' sseħħ (ara sezzjoni 4.8).
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
Maltese: Infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall-ġisem) ġiet irrappurtata b'mod rari b'mediċini oħra bħal din (eż. filgrastim, lenograstim jew pegfilgrastim talgrupp ta' G-CSFs).
English: Hypersensitivity reactions*
Maltese: Reazzjonijiet ta' sensittività eċċessiva*
English: The safety and efficacy of Lonquex have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.
Maltese: Is-sigurtà u u l-effikaċja ta' Lonquex ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' dewmien fil-majelosoppressjoni, eż. nitrosoureas.
English: Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no associated clinical effects.
Maltese: Żidiet riversibbli, minn ħfief sa moderati fil-livell ta' alkaline phosphatase u lactate dehydrogenase,
English: Nevertheless, pharmacodynamic effects were similar and independent from gender and injection site.
Maltese: Madankollu, l-effetti farmakodinamiċi kienu simili u indipendenti mis-sess tal-persuna u s-sit tal-injezzjoni.
English: Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim.
Maltese: Lipegfilgrastim jeħel mar-riċettur ta' G-CSF uman bħal filgrastim u pegfilgrastim.
English: Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility (see section 5.3).
Maltese: Studji f'annimali b'G-CSF u derivati ma jurux effetti ħżiena firrigward tal-fertilità (ara sezzjoni 5.3).
English: Published information on G-CSF and derivatives reveal no evidence of adverse effects on fertility and embryo-foetal development in rats or pre-/postnatal effects other than those related to maternal toxicity as well.
Maltese: Informazzjoni ppubblikata fuq G-CSF u derivati ma żvelat l-ebda evidenza ta' effetti avversi fuq il-fertilità u l-iżvilupp embrijufetali fil-firien jew effetti ta' qabel jew wara t-twelid, ħlief dawk marbuta ma' tossiċità materna wkoll.
English: G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis.
Maltese: G-CSF iżid ukoll lattivitajiet antibatteriċi tan-newtrofili li jinkludu l-fagoċitosi.
English: The study showed non-inferiority of 6 mg lipegfilgrastim to 6 mg pegfilgrastim for the primary endpoint, duration of severe neutropenia (DSN) in the first cycle of chemotherapy (see table 2).
Maltese: L-istudju wera nuqqas ta' inferjorità tad-doża ta' 6 mg ta' lipegfilgrastim meta mqabbla mad-doża ta' 6 mg ta' pegfilgrastim għall-punt aħħari primarju, dewmien ta' newtropenija severa (DSN) fl-ewwel ċiklu ta' kimoterapija (ara tabella 2).
English: Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity.
Maltese: Pazjenti li għandhom sensittività eċċessiva għal G-CSF jew derivati huma wkoll f'riskju ta' reazzjonijiet ta' sensittività eċċessiva għal lipegfilgrastim minħabba l-possibbiltà ta' reattività inkroċjata.
English: Patients with myeloid leukaemia or myelodysplastic syndromes
Maltese: Pazjenti b'lewkimja majelodje jew sindromi majelodisplastiċi
English: Pull straight as shown in pictures 1 and 2.
Maltese: Iġbed bi dritt kif muri fi istampi 1 u 2.
English: In a phase 1 study of 21 children aged between 2 and 16 years with Ewing family of tumours or rhabdomyosarcoma, lipegfilgrastim was administered as a single subcutaneous dose of 100 μg/kg (up to a maximum of 6 mg, which is the fixed dose for adults) 24 hours after the end of the last chemotherapy treatment in week 1 of the regimen.
Maltese: Fi studju ta' fażi 1 ta' 21 tifel/tifla ta' bejn sentejn u 16-il sena bil-familja ta' tumuri Ewing jew b'rabdomijosarkoma, lipegfilgrastim ingħata bħala doża waħda taħt il-ġilda ta' 100 μg/kg (sa massimu ta' 6 mg, li hija d-doża fissa għall-adulti) 24 siegħa wara t tmiem tal-aħħar trattament ta' kimoterapija f'ġimgħa 1 tal-kors.
English: Each pre-filled syringe contains 30 mg sorbitol.
Maltese: Kull siringa mimlija għal-lest fiha 30 mg ta' sorbitol.
English: Lonquex is indicated in adults for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Maltese: Lonquex huwa indikat f'adulti għal tnaqqis fit-tul ta' żmien ta' newtropenija u fl-inċidenza ta' newtropenija bid-deni f'pazjenti ttrattati b'kimoterapija ċitotossika għal tumur malinn (bl-eċċezzjoni ta' lewkimja majelodje kronika u sindromi majelodisplastiċi).
English: Elevations in alkaline phosphatase and lactate dehydrogenase most likely originate from the increase in neutrophils.
Maltese: Żidiet fil-livelli ta' alkaline phosphatase u lactate dehydrogenase x'aktarx li joriġinaw miż-żieda fin-newtrofili.
English: For more information, see section 5.1.
Maltese: Għal aktar informazzjoni, ara sezzjoni 5
English: A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Maltese: L-għadd tal-WBC għandu jitwettaq f'intervalli regolari matul terapija minħabba l-effetti kliniċi ta' lipegfilgrastim u l-potenzjal għal lewkoċitosi.
English: In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim.
Maltese: Fi studji kliniċi b'numru limitat ta' pazjenti anzjani, ma kien hemm l-ebda differenza rilevanti marbuta mal-età fir-rigward tal-profili tal-effikaċja jew tas-sigurtà ta' lipegfilgrastim.
English: The experience in children is limited to a single-dose phase 1 study in 21 paediatric patients aged 2 to <18 years (see section 5.1), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults.
Maltese: L-esperjenza fit-tfal hija limitata għal studju ta' fażi 1 ta' doża waħda f'21 pazjent pedjatriku ta' bejn sentejn u <18-il sena (ara sezzjoni 5.1), li ma indikatx differenza fil-profil tas-sigurtà ta' lipegfilgrastim fit-tfal meta mqabbel ma' dak fl-adulti.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Maltese: Pazjenti bi storja medika riċenti ta' infiltrati pulmonari jew pnewmonja jistgħu jkunu f'riskju ogħla.
English: As a precautionary measure, it is preferable to avoid the use of Lonquex during pregnancy.
Maltese: Bћala prekawzjoni hu preferribli li ma jintużax Lonquex waqt it-tqala.
English: No neutralising antibodies against lipegfilgrastim were observed.
Maltese: L-ebda antikorpi li jinnewtralizzaw kontra lipegfilgrastim ma ġew osservati.
English: This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg).
Maltese: Dan jista' jirriżulta f'risponsi farmakodinamiċi iktar baxxi f'pazjenti ħoxnin (> 95 kg).
English: Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Maltese: Tromboċitopenija u lewkoċitosi ġew irrappurtati (ara sezzjoni 4.4).
English: Musculoskeletal pain is generally of mild to moderate severity, transient and can be controlled in most patients with standard analgesics.
Maltese: L-uġigħ muskoloskeletriku ġeneralment ikun ta' severità minn ħafif sa moderat, temporanju u jista' jiġi kkontrollat fil-biċċa l-kbira tal-pazjenti b'analġesiċi standard.
English: How Lonquex is used
Maltese: Lonquex ukoll.
English: In such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given.
Maltese: F'dawn iċ-ċirkustanzi, Lonquex għandu jitwaqqaf fid-diskrezzjoni tat-tabib u jingħata trattament adattat.
English: Patients were randomised 2:1 to receive either 6 mg lipegfilgrastim or placebo.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:1 biex jirċievu jew 6 mg ta' lipegfilgrastim jew plaċebo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lonquex in all subsets of the paediatric population in the treatment of chemotherapy-induced neutropenia and prevention of chemotherapy-induced febrile neutropenia (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Lonquex f'kull sett tal-popolazzjoni pedjatrika fit-trattament ta' newtropenija kkaġunata millkimoterapija u l-prevenzjoni ta' newtropenija bid-deni kkaġunata mill-kimoterapija (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim.
Maltese: 506 pazjent u 76 voluntiera b'saħħithom ittrattati mill-inqas darba b'lipegfilgrastim.
English: How Lonquex works
Maltese: Tużax Lonquex: