FrancophonIA/ELRC3.0 huggingface dataset:
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Maltese: Il-grupp ta' l-iżgħar età (0-5 snin) kellu esponiment medju ogħla għal pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) minn tfal akbar b'età ta' 6-11-il sena u 12-21 sena (22.0 ± 13.1 μg·hr/ml u 29.3 ± 23.2 μg·hr/ml, rispettivament) (ara sezzjoni 5.1).
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Maltese: Dejta limitata tindika li l-farmakokinetika ta' pegfilgrastim fl-anzjani (> 65 sena) hija simili għal dik fl-adulti.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħal ma kull proteini terapewtiċi oħra, hemm potenzjal għal immunoġeniċità.
English: Front - Ristempa reference guide:
Maltese: Wara- Ristempa gwida ta'referenza:
English: White blood cell (WBC) counts of 100 x 10
Maltese: Għadd ta' ċelluli bojod (WBC) ta' 100 x 10
English: Ristempa contains sorbitol (a type of sugar).
Maltese: Ristempa fih sorbitol (tip ta' zokkor).
English: The concentration is 10 mg/ml based on protein only**.
Maltese: Ilkonċentrazzjoni hija ta' 10 mg/ml ibbażata fuq il-proteina biss**.
English: EU/1/15/996/001 1 pack blistered syringe EU/1/15/996/002 1 pack unblistered syringe EU/1/15/996/003 1 pack blistered syringe with needle guard
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/996/001 pakkett ta' siringa waħda f'folja EU/1/15/996/002 pakkett ta' siringa waħda mhux fil-folja EU/1/15/996/003 pakkett ta' siringa waħda b'għatu ta' protezzjoni tal-labra f'folja
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Maltese: Pegfilgrastim huwa proteina magħmula millbijoteknoloġija fil-batterja msejħa E. coli.
English: What Ristempa contains - The active substance is pegfilgrastim.
Maltese: X'fih Ristempa - Is-sustanza attiva hi pegfilgrastim.
English: Uncommon (≥ 1/1,000 to
Maltese: Komuni (≥ 1/100 sa
English: Common (≥ 1/100 to < 1/10) cases of leukocytosis (White Blood Count [WBC] > 100 x 10
Maltese: Kienu rrappurtati każijiet komuni (≥1/100 sa <1/10) ta' lewkoċitosi (Għadd ta' Ċelluli bojod tadDemm [WBC] > 100 x 10
English: Ristempa contains the active substance pegfilgrastim.
Maltese: Ristempa fih is-sustanza attiva Pegfilgrastim.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 10
Maltese: Fi studju multicentre, randomised, open-label ta' fażi II (n = 37) fuq pazjenti pedjatriċi b'sarkoma li kienu qed jirċievu 100 μg/kg pegfilgrastim wara ċiklu 1 ta' kimoterapija ta' vincristine, doxorubicin u cyclophosphamide (VAdriaC/IE), kienet osservata tul itwal ta' newtropenija severa (newtrofili < 0.5 x 10
English: See leaflet for further information.
Maltese: Sorsi oħra ta' Informazzjoni
English: Ristempa contains sorbitol (E420) and sodium acetate
Maltese: Ristempa fih sorbitol (E420) u sodium acetate.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Hija tippermetti monitoraġġ kontinwu tal-bilanċ ta' benefiċċju / riskju tal-prodott mediċinali.
English: See section 4.
Maltese: Ara sezzjoni 2.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Maltese: Dan jista 'jkun sinjal ofAcute Respiratory Syndrome Diffikultà ( ARDS )
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Maltese: Pegfilgrastim huwa magħmul minn molekola ta' G-CSF umana rikombinanti (r-metHuG-CSF) marbuta b'rabta kovalenti ma' molekola waħda ta' polyethylene glycol (PEG) ta' 20 kd.
English: • 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
Maltese: • reċentement kellek infezzjoni serja tal-pulmun ( pnewmonja ) , fluwidu fil- pulmuni ( edema pulmonari ) , infjammazzjoni tal -pulmun (mard interstizjali tal-pulmun ), jew bħala anormali tas-sider x -ray ( infiltrazzjoni tal-pulmun )
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Maltese: • jekk int allerġiku/a għal pegfilgrastim, filgrastim, proteini ġejjin minn E.Coli, jew xi sustanza oħra ta' din il-mediċina.
English: 9/l) have been reported (see section 4.4).
Maltese: L-effett fit-tul ma ġiex studjat (ara sezzjoni 4.4).
English: Sweet's syndrome (acute febrile dermatosis) Cutaneous vasculitis
Maltese: Sindrome ta' Sweet (dermatożi akuta biddeni)1,2;
English: Syringe safety guard
Maltese: Molla protettiva tal
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Maltese: Il-farmakokinetika ta' pegfilgrastim kienet studjata f'37 pazjent pedjatriku b'sarkoma, li rċevew 100 μg/kg pegfilgrastim wara li temmew kimoterapija VAdriaC/IE.
English: Nervous system disorders Vascular disorders
Maltese: Disturbi fissistema nervuża Disturbi tal-vini
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 il-website ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu/.
English: The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Ristempa in nine randomized clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata minn kalkolu statistiku bbażat fuq 1576 pazjent li kienu qed jirċievu Ristempa f' disa' provi kliniċi randomised
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Maltese: Sindrome ta' Distress Respiratorju Akut ; Reazzjonijiet avversi relatati mal-pulmun (pulmonite interstizjali, edima filpulmun, infiltrati filpulmun u fibrosi filpulmun)
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001).
Maltese: L-inċidenza tan-newtropenija bid-deni kienet aktar baxxa f'pazjenti li rċevew pegfilgrastim meta mqabbla ma' dawk li reċevew il-plaċebo (1% versus 17%, p<0.001).
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Maltese: Glomerulonefrite ġiet irrapportata f'pazjenti li qed jirċievu filgrastim u pegfilgrastim.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with Ristempa (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 ta' wara b'Ristempa (mhux komuni [≥ 1/1000 sa < 1/100]).
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFT's for ALT or AST1
Maltese: Żjidiet f'lactate dehydrogenase u alkaline phosphatase1;
English: Uncommon (≥1/1,000 to < 1/100) pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Reazzjonijiet mhux mixtieqa mhux komuni (≥ 1/1000 sa < 1/100) relatati mal-pulmun, b'mod partikulari pulmonite interstizjali, ġew irrappurtati wara l-għoti tal-fattur li jistimola l-kolonji ta' granuloċiti.
English: In a second study (n = 310), which used a weightadjusted dose (100 μg /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 µg/kg), id-dewmien medju tan-newtropenija grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 i, mqabbel ma' 1.8 ijiem talgrupp b'filgrastim (differenza ta' 0.03 ijiem, 95% CI -0.36, 0.30).
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żjidiet mhux komuni f'ALT (alanine aminotransferase) jew f'AST (aspartate aminotransferase), fittestijiet tal-funzjoni tal-fwied (LFTs), ġew osservati f'pazjenti wara li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Maltese: Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20, ilma għall-injezzjoni.
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Maltese: Rati ta' produzzjoni ta' antikorpi kontra pegfilgastrim huma ġeneralment baxxi.
English: “SNAP”
Maltese: “TFAQQIĦA”
English: Ristempa 6 mg injection Pegfilgrastim
Maltese: Ristempa 6 mg injezzjoni Pegfilgrastim
English: Ristempa is for use in adults aged 18 and over.
Maltese: Ristempa huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: Elevations in uric acid
Maltese: Żjidiet fil-uric acid
English: Ristempa 6 mg injection Pegfilgrastim SC
Maltese: Ristempa 6 mg injezzjoni Pegfilgrastim SC
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults.
Maltese: Kienet osservata frekwenza ogħla ta' avvenimenti avversi serji fi tfal iżgħar b'età ta' 0-5 snin (92%) meta mqabbla ma' tfal akbar b'età ta' 6-11 u 12-21 sena rispettivament (80% u 67%) u ma' 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: 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 jistimola l-kolonji ta' granuloċiti) prodotta mill-ġisem tiegħek stess.
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 to7 days, and a 30-40% incidence of febrile neutropenia.
Maltese: Fin-nuqqas ta' appoġġ ta' fattur tat-tkabbir, ġie rrappurtat li din l-iskema ta' dożaġġ tirriżulta f'newtropenija ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30-40% ta' newtropenija bid-deni.
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, ta' importanza kbira, f'pazjenti b'kankru tas-sider ta' riskju għoli ta' stadju II-IV li kienu qed jingħataw kimoterapija majelosopressiva li tikkonsisti f'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: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Maltese: Ġeneralment , avvenimenti ta ' glomerulonefrite solvuti wara tnaqqis fid-doża jew irtirar ta' filgrastim u pegfilgrastim.
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Ristempa with any other medicinal products.
Maltese: Ma sarux studji speċifiċi dwar l-interazzjonijiet jew il-metaboliżmu, madankollu, provi kliniċi ma indikawx interazzjoni ta' Ristempa ma' prodotti mediċinali oħra.
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Maltese: Sindromu ta' tnixxija tal-kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament huwa tardjat, ġie irrapportat b'mod mhux komuni (≥ 1/1000 sa <1/100) f'pazjenti b' kanċer waqt il-kimoterapija wara l-għoti ta' fatturi li jistimulaw kolonji granuloċiti; ara sezzjoni 4.4 u sezzjoni “Deskrizzjoni ta' xi reazzjonijiet avversi magħżula” ta' taħt.
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-dejta fit-tabella isfel tiddeskrivi reazzjonijiet avversi rrappurtati minn provi kliniċi u minn rappurtar spontanju.
English: Separate additional insert:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made
Maltese: L-informazzjoni li hawn bħalissa qegħda f'sezzjonijiet 4.8, 5.1 u 5.2 imma l-ebda rekkomandazzjoni fuq il-posoloġija ma tista issir.
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 mil-kliewi hija mnaqqsa.
English: 9/l or greater have been observed in less than 1% of patients receiving Ristempa.
Maltese: 9/l, din il-mediċinagħandha titwaqqaf minnufih.
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 μg/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 μg/kg pegfilgrastim wara li temmew doxorubicin/docetaxel (ara sezzjonijiet 4.8 u 5.1).
English: Other medicines and Ristempa
Maltese: Mediċini oħra u Ristempa
English: Injection site reactions, including injection site erythaema (uncommon (≥ 1/1000 to < 1/100)) as well as injection site pain (common events ≥ 1/100 to < 1/10) have occurred on initial or subsequent treatment with Ristempa.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni, inkluż eritema fis-sit tal-injezzjoni (mhux komuni (≥ 1/1000 sa < 1/100)) u kif ukoll uġigħ fis-sit tal-injezzjoni ( avvenimenti kommuni ≥1/100 sa <1/10) seħħew mal-ewwel trattament jew ma' trattament sussegwenti b'Ristempa.
English: Each pre-filled syringe contains 30 mg sorbitol (E420) Each pre-filled syringe contains less than 1 mmol (23 mg) sodium (see section 4.4).
Maltese: Kull siringa mimlija għal-lest fiha inqas minn 1mmol (23mg) sodium (ara sezzjoni 4.4).
English: 9) was observed in younger children aged 0-5 yrs (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: BLISTERED SYRINGE LABEL
Maltese: Labra użata
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' żjieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-sindrome ta' batija respiratorja akuta (ARDS).
English: Sickle cell anaemia
Maltese: Tromboċitopenja u anemija
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 interstizjali, edima fil-pulmun, infiltrati fil-pulmun u fibrożi fil-pulmun.
English: Ristempa 6 mg solution for injection.
Maltese: Ristempa 6 mg soluzzjoni għall-injezzjoni.
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Maltese: • Iz-zaqq, ħlief 5cm (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 biddeni kienet ta' 9% tal-pazjenti kkurati b'pegfilgrastim u 18% tal-pazjenti kkurati b'filgrastim (differenza ta' 9%, 95% CI ta' -16.
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), varji stadji ta' indeboliment renali, inkluż mard renal ta' l-aħħar stadju, ma kellhom l-ebda impatt fuq il-farmakokinetika ta' pegfilgrastim.
English: The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p  0.001; and 2% versus 10%, p  0.001).
Maltese: IV assoċjati ma' dijanjożi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbla mal-grupp tal-plaċebo (1% versus 14%, p0.
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving Ristempa (uncommon) (see section 4.4).
Maltese: Reazzjonijiet allerġiċi serji, inkluż anafilassi jistgħu jseħħu f'pazjenti li jirċievu Ristempa (mhux komuni) (ara sezzjoni 4.4).
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 kkurati b'kimoterapija ċitotossika għal tumur malinn (bl-eċċezzjoni ta' lewkimja majelojde kronika u sindromi majelodisplastiċi).
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-żjieda 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: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Maltese: Il-potenzjal ta' interazzjoni ma' lithium, li wkoll jippromovi il-ħelisen ta' newtrofili, ma ġiex speċifikament investigat.
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 Ristempa following cytotoxic chemotherapy.
Maltese: Żjidiet ħfief sa moderati li jerġgħu għan-normal, u mingħajr effetti kliniċi assoċjati, fil-uric acid u f'alkaline phosphatase kienu osservati b'mod mhux komuni; żjidiet ħfief sa moderati li jerġgħu għannormal, u mingħajr effetti kliniċi assoċjati, f'lactate dehydrogenase, kienu osservati b'mod mhux komuni f'pazjenti li ngħataw Ristempa wara kimoterapija ċitotossika.
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 nef, li jistgħu jkunu assoċjati ma' mogħdija ta-ilma inqas frekwenti, diffikultà biex tieħu nifs, nefħa addominali u sensazzjoni ta' milja, u sensazzjoni ġenerali ta' għeja.
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Maltese: • ħsara lill -filtri ċkejkna ġewwa kliewi tiegħek (glomerulonefrite ).
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 (see section 5.1).
Maltese: Dejta klinika limitata tissuġġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenija severa f'pazjenti li reġgħet qabdithom lewkimja majelojde akuta mill-ġdid, huwa komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: The safety and efficacy of Ristempa administration in de novo AML patients aged  55 years with cytogenetics t(15;17) have not been established.
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' Ristempa ma' ċitoġenetiċi t(15;17) f'pazjenti taħt il-55 sena li reġgħet qabdithom lewkimja majelojde akuta mill-ġdid, għadhom ma ġewx stabbiliti.
English: What Ristempa looks like and contents of the pack Ristempa is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Maltese: Id-Dehra ta' Ristempa u l-kontenuti tal-pakkett Ristempa huwa soluzzjoni ċara u bla kulur għall-injezzjoni ġo siringa mimlija għal-lest (6 mg/0.6 ml).
English: Permanently discontinue Ristempa in patients with clinically significant hypersensitivity.
Maltese: Ristempa għandu jitwaqqaf għal kollox f'pazjenti li jkollhom ipersensitivita klinikament sinjifikanti.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħra, partikolarment ma' soluzzjonijiet ta' sodium chloride.
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, fuq pazjenti bil-kankru tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' ċiklu ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20% (docetaxel 100 mg/m kull 3 ġimgħat għal 4 ċikli).
English: Anaphylaxis
Maltese: Injezzjoni