FrancophonIA/ELRC3.0 huggingface dataset:
English: Xelevia is a medicine that contains the active substance sitagliptin.
Maltese: Xelevia huwa mediċina li fiha s-sustanza attiva sitagliptina.
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
Maltese: L-ipogliċemija ġiet irrapportata bl-użu tas-sulfonilurea f'4.7-13.8% tal-pazjenti u f'9.6% tal-pazjenti bl-użu tal-insulina.
English: This is a summary of the European public assessment report (EPAR) for Xelevia.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xelevia.
English: Xelevia is taken at a dose of 100 mg once a day.
Maltese: jittieħed f'doża ta' 100 mg darba kuljum.
English: Serious side effects reported with Xelevia (generally seen in more than 5% of patients) include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Maltese: L-effetti sekondarji serji li ġew irrapportarti bl-użu ta' Xelevia inkludew pankreatite (infjamazzjoni talfrixa) u ipersensittività (reazzjonijiet allerġiċi).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xelevia on 21 March 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xelevia fil-21 ta' Marzu 2007.
English: • three additional studies compared Xelevia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Maltese: • tliet studji oħra qabblu lil Xelevia ma' plaċebo meta żdiedu ma' mediċini oħrajn kontra d-dijabete: il-glimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, fuq 441 pazjent; it-taħlita talmetformina u r-rosiglitażonu (agonista PPAR gamma) fuq 278 pazjent; u doża stabbli ta' insulina, bil-metformina jew mingħajrha, fuq 641 pazjent.
English: In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Maltese: F'pazjenti li ngħataw Xelevia waħdu, il-livelli tal-HbA1c naqsu minn madwar 8.0% fil-bidu talistudji b'0.48% wara 18-il ġimgħa u b'0.61% wara 24 ġimgħa.
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Xelevia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Maltese: Il-livelli tal-HbA1c tnaqqsu b'1.03% wara 18-il ġimgħa f'pazjenti li żiedu Xelevia malmetformina u r-rosiglitażonu, apparagun ma' tnaqqis ta' 0.31% f'dawk li żiedu l-plaċebo.
English: What is the risk associated with Xelevia?
Maltese: X'inhu r-riskju assoċjat ma' Xelevia?
English: Why has Xelevia been approved?
Maltese: Għaliex ġie approvat Xelevia?
English: Finally, they were reduced by 0.59% in patients adding Xelevia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Maltese: Fl-aħħar nett, tnaqqsu b'0.59% f'pazjenti li żiedu Xelevia mal-insulina (bil-metformina jew mingħajrha), apparagun ma' tnaqqis ta' 0.03% f'dawk li żiedu l-plaċebo.
English: The other study compared Xelevia with metformin, used on their own, in 1,058 patients;
Maltese: Listudju l-ieħor qabbel lil Xelevia mal-metformina, użati waħedhom, fuq 1,058 pazjent;
English: What is Xelevia?
Maltese: X'inhu Xelevia?
English: • four of the studies compared Xelevia with placebo (a dummy treatment): Xelevia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Maltese: Xelevia jew plaċebo ntużaw waħedhom f'żewġ studji fuq 1,262 pazjent, bħala żieda mal-metformina fi studju wieħed fuq 701 pazjent, u bħala żieda mal-pijoglitażonu (agonista PPAR-gamma) fi studju fuq 353 pazjent;
English: One study compared Xelevia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Maltese: Studju minnhom qabbel lil Xelevia mal-glipiżide (sulfonilurea), meta ntużaw bħala żieda mal-metformina fuq 1,172 pazjent.
English: In the additional studies, adding Xelevia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in those adding placebo.
Maltese: Fl-istudji ulterjuri, iż-żieda ta' Xelevia mal-glimepiride (bil-metformina jew mingħajrha) ikkaġunat tnaqqis fil-livelli tal-HbA1c ta' 0.45% wara 24 ġimgħa, apparagun ma' żieda ta' 0.28% fil-pazjenti li żiedu l-plaċebo.
English: In patients with moderately or severely reduced kidney function the dose of Xelevia should be reduced.
Maltese: F'pazjenti li jkollhom tnaqqis moderat jew gravi fil-funzjoni tal-kliewi d-doża ta' Xelevia għandha titbaxxa.
English: When added to pioglitazone, Xelevia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Maltese: Meta żdied mal-pijoglitażonu, Xelevia naqqas il-livelli tal-HbA1c b'0.85% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.15% f'pazjenti li żiedu l-plaċebo.
English: In contrast, they rose by 0.12% and 0.18%, respectively, in the patients taking placebo.
Maltese: Min-naħa l-oħra għolew b'0.12% u b'0.18% rispettivament f'pazjenti li ħadu l-plaċebo.
English: HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Biż-żieda ta' Xelevia mal-metformina, il-livelli talHbA1c tnaqqsu b'0.67% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.02% f'pazjenti li żiedu l plaċebo.
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;
Maltese: • flimkien jew mal-metformina, u mas-sulfonilurea jew agonista PPAR gamma fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti biż-żewġ mediċini;
English: When taken on their own, Xelevia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Xelevia seemed to be slightly lower than that of metformin.
Maltese: Meta ttieħdu waħedhom, Xelevia u l-metformina pproduċew tnaqqis simili fil-livelli tal-HbA1c, iżda l-effikaċja ta' Xelevia dehret li kienet ftit inqas minn dik tal-metformina.
English: How is Xelevia used?
Maltese: Għal xiex jintuża Xelevia?
English: • in combination with insulin, with or without metformin, in patients who are not satisfactorily controlled on a stable dose of insulin.
Maltese: • flimkien mal-insulina, bil-metformina jew mingħajrha, fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti b'doża stabbli tal-insulina.
English: If Xelevia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Xelevia jittieħed mas-sulfonilurea jew mal-insulina, jista' jenħtieġ li d-doża tas-sulfonilurea jew tal-insulina titbaxxa ħalli jitnaqqas ir-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Is-sitagliptina tnaqqas ukoll l-ammont ta' glukożju magħmul mill-fwied billi tgħolli l-livelli tal-insulina u tnaqqas il-livelli tal-ormon glukagonu.
English: By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Biż-żieda tal-livelli ta' ormoni inkretini fid-demm, is-sitagliptina tistimula lill-frixa ħalli tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: • two studies compared Xelevia with other antidiabetes medicines.
Maltese: • żewġ studji qabblu lil Xelevia ma' mediċini oħra kontra d-dijabete.
English: How has Xelevia been studied?
Maltese: Kif ġie studjat Xelevia?
English: 117 allée des Parcs 69800 Saint-Priest France
Maltese: 117 allée des Parcs 69800 Saint-Priest Franza
English: 20th km Hosur Road Electronics City, Bangalore, Karnataka IN-560 100
Maltese: 20th km Hosur Road Electronics City, Bangalore, Karnataka
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Maltese: Sindrome ta' Sweet (dermatożi akuta bid-deni)1,2;
English: Sickle cell crisis2; Splenomegaly2;
Maltese: Kriżi taċ-ċellula forma ta' minġel2; Splenomegalija2;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2018
English: 0.6 mL of solution.
Maltese: INDIVIDWALI 0.6 mL
English: Fulphila contains sorbitol and sodium acetate
Maltese: Fulphila fih sorbitol u sodium acetate
English: INFORMATION IN BRAILLE Fulphila
Maltese: INFORMAZZJONI BIL-BRAILLE fulphila
English: Common (≥ 1/100 to < 1/10)
Maltese: (≥1/10) (≥1/100 sa <1/10) (≥1/1,000 sa sa <1/1,000)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1329/001 1 pre-filled syringe EU/1/18/1329/002 1 pre-filled syringe with needle guard
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1329/001 1 siringa mimlija għal-lest EU/1/18/1329/002 1 siringa mimlija għal-lest bi protezzjoni tal-labra
English: See section 2 “Fulphila contains sorbitol and sodium”.
Maltese: Ara sezzjoni 2 “Fulphila fih is-sorbitol u s-sodium”.
English: Sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Maltese: Sodium acetate, sorbitol (E420), polysorbate 20, ilma għall-injezzjonijiet.
English: Fulphila contains the active substance pegfilgrastim.
Maltese: Fulphila fih is-sustanza attiva Pegfilgrastim.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Maltese: Kienu rrappurtati każijiet komuni ta' lewkoċitosi (Għadd ta' Ċelluli bojod tad-Demm (White Blood Count [WBC] >100 × 109/L) (ara sezzjoni 4.4).
English: BGP Products ApS Tlf: + 45 28116932
Maltese: Danmark BGP Products ApS Tlf: + 45 28116932
English: Fulphila is a biosimilar medicinal product.
Maltese: Fulphila huwa prodott mediċinali bijoloġiku simili.
English: Glomerulonephritis2
Maltese: Glomerulonefrite2
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 G-CSF rikombinanti uman (r-metHuGCSF - recombinant human G-CSF) marbut b'rabta kovalenti ma' molekola waħda ta' polyethylene glycol (PEG) ta' 20 kd.
English: Mylan Medical S.A.S Tel: +33 1 56 64 10 70
Maltese: Mylan Medical S.A.S Tél : +33 1 56 64 10 70
English: Water for injections *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Maltese: Ilma għall-injezzjonijiet * Sodium acetate huwa magħmul permezz ta' titrazzjoni ta' glacial acetic acid ma' sodium hydroxide.
English: Nausea1
Maltese: Nawsja1
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (Area Under Curve (AUC)) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1).
Maltese: Il-grupp tal-iżgħar età (0-5 snin) kellu esponiment medju ogħla għal pegfilgrastim (AUC) (± Standard Deviation) (47.9 ±22.5 mcg siegħa/mL) minn tfal akbar b'età ta' 6-11-il sena u 12-21 sena (22.0 ±13.1 mcg hr/mL u 29.3 ±23.2 mcg siegħa/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: Data limitata tindika li l-farmakokinetika ta' pegfilgrastim f'individwi anzjani (>65 sena) hija simili għal dik fl-adulti.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1
Maltese: Żidiet f'lactate dehydrogenase u alkaline phosphatase1;
English: What Fulphila contains - The active substance is pegfilgrastim.
Maltese: X'fih Fulphila - Is-sustanza attiva hi 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 kontra l-infezzjonijiet assoċjati ma' dijanjosi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbla mal-grupp tal-plaċebo (1% versus 14%, p<0.001; u 2% versus 10%, p<0.001).
English: Each pre-filled syringe contains 30 mg sorbitol (E420).
Maltese: Kull siringa mimlija għal-lest fiha 30 mg sorbitol (E-420).
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata minn kalkolu statistiku bbażat fuq 1,576 pazjent li kienu qed jirċievu pegfilgrastim f'disa' provi kliniċi randomised.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' pegfilgrastim.
English: Fulphila is for use in adults aged 18 and over.
Maltese: Fulphila huwa għall-użu f'adulti minn 18-il sena ‘l fuq.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Maltese: Għadd ta' ċelluli bojod tad-demm (WBC - white blood cell) ta' 100 × 109/L jew aktar ġew osservati f'inqas minn 1% tal-pazjenti li kienu qed jirċievu pegfilgrastim.
English: - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall-injezzjoni.
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: Żidiet mhux komuni fit-testijiet tal-funzjoni tal-fwied (LFTs - liver function tests) għal alanine aminotransferase (ALT) jew f'aspartate aminotransferase (AST), ġew osservati f'pazjenti wara li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: Loss of response to Fulphila
Maltese: Mediċini oħra u Fulphila
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) 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: Fi studju b'aktar minn ċentru wieħed, randomised, open-label ta' fażi II (n=37) fuq pazjenti pedjatriċi b'sarkoma li kienu qed jirċievu 100 mcg/kg pegfilgrastim wara ċiklu 1 ta' kimoterapija ta' vincristine, doxorubicin u cyclophosphamide (VAdriaC/IE), kien osservat tul itwal ta' newtropenija severa (newtrofili <0.5 × 109) 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: Very rare
Maltese: Rari
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythema, 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: - coughing up blood (haemoptysis).
Maltese: - sogħla tad-demm (emoptiżi).
English: The syringe is provided with a blister wrapping, the syringe is provided with an automatic needle guard.
Maltese: Is-siringa hi pprovduta bi tgeżwir tal-folja, is-siringa hi pprovduta bi protezzjoni awtomatika tal-labra.
English: Fulphila 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: Fulphila 6 mg soluzzjoni għall-injezzjoni pegfilgrastim
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculo-skeletal pain, neck pain)
Maltese: Uġigħ muskoluskeletriku (majalġja, artralġja, uġigħ flestremitajiet, uġigħ fid-dahar, uġigħ muskolu-skeletriku, uġigħ fl-għonq)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL solution for injection (10 mg/mL).
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim f'0.6 mL ta' soluzzjoni għall-injezzjoni (10 mg/mL).
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis); Haemoptysis
Maltese: Reazzjonijiet avversi relatati mal-pulmun (pulmonite talinterstizju, edima fil-pulmun, infiltrati filpulmun u fibrosi fil-pulmun);;
English: For more information, see section 5.1 Excipient with known effect
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1 Eċċipjenti b'effett magħruf
English: Fulphila may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Maltese: Fulphila jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perjodu wieħed ta' massimu ta' 72 siegħa.
English: OTHER
Maltese: Importanti
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva
English: Cutaneous vasculitis1,2
Maltese: Vaskulite filġilda1,2
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: 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: Sindrome ta' Tnixxija tal-Kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament ikun ittardjat, ġie irrappurtat bħala mhux komuni (≥1/1,000 sa <1/100) f'pazjenti bil-kanċer waqt il-kimoterapija wara l-għoti ta' fatturi li jistimulaw kolonja ta' granuloċiti; ara sezzjoni 4.4 u s-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt.
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' reazzjonijiet avversi serji fi tfal żgħar 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: 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: Fi studju open label ta' doża waħda (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: 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: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Maltese: Ma sarux studji speċifiċi dwar l-interazzjonijiet jew il-metaboliżmu, madankollu, provi kliniċi ma indikawx interazzjoni ta' pegfilgrastim ma' prodotti mediċinali oħra.
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 randomised biex jirċievu pegfilgrastim meta mqabbla ma' dawk li rċevew plaċebo (1% versus 17%, p<0.001).
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: 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: 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 tan-newtropenija 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: 1 single use pre-filled syringe (0.6 mL).
Maltese: 1 siringa mimlija għal-lest li tintuża darba biss (0.6 mL).
English: In a second study (n = 310), which used a weight-adjusted 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: How do you, or the person injecting you, use Fulphila pre-filled syringe?
Maltese: Kif nipprepara l-injezzjoni ta' Fulphila?
English: Marketing Authorisation Holder Mylan S.A.S.
Maltese: FIS-SUQ Mylan S.A.S.
English: Capillary leak syndrome1
Maltese: Sindrome ta' tnixxija talkapillari1
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 medicinal product.
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' dan il-prodott mediċinali.