FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the MAHs provided 6 publications (dated from 1983 to 1998) with an adequate design (randomised, double-blind, placebo controlled) to support the claim for efficacy, plus one study in vascular cognitive impairment which wasnot further discussed.
Maltese: B'mod ġenerali, għall-indikazzjoni “kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja)”, il-MAHs ipprovdew 6 pubblikazzjonijiet (datati mill-1983 sal-1998) b'disinn adegwat (randomizzati, bi blindaġġ doppju, ikkontrollati bi plaċebo) biex jappoġġaw it-talba għall-effikaċja, flimkien ma' studju f'indeboliment konjittiv vaskulari li ma kienx diskuss ulterjorment.
English: The studies included young and old patients (1878 years old) with idiopathic acrosyndrome.
Maltese: L-istudji kienu jinkludu pazjenti żgħar u anzjani (18-78 sena) b'acrosyndrome idjopatiku.
English: For the indication “ancillary treatment of Raynaud's syndrome”, all the studies submitted in support of this indication were considered by the CHMP of poor methodological quality (i.e. uncontrolled, open designed, with a low number of patients (n=20-37)).
Maltese: Għall-indikazzjoni “kura anċillari tas-sindromu ta' Raynaud”, l-istudji kollha ppreżentati b'appoġġ għal din l-indikazzjoni kienu meqjusa mis-CHMP bħala ta' kwalità metodoloġika fqira (jiġifieri mhux ikkontrollati, b'disinn miftuħ, b'għadd baxx ta' pazjenti (n=20-37)).
English: In 2 studies patients presented a clinical diagnosis of mild organic brain syndrome (stage 2-3 on the Global Deterioration Scale) (Scarzella study) and an early stage senile cerebral deterioration without dementia or major dependence with respect to the environment, based on DSM-III criteria (Babeau study).
Maltese: F'2 studji l-pazjenti ppreżentaw dijanjosi klinika tas-sindromu organiku ħafif tal-moħħ (stadju 2-3 fuq l-Iskala Globali ta' Deterjorazzjoni) (l-istudju Scarzella) u deterjorazzjoni ċerebrali senili fi stadju bikri mingħajr dimenzja jew dipendenza maġġuri fir-rigward tal-ambjent, abbażi talkriterji tad-DSM-III (l-istudju Babeau).
English: In fact, dihydroergocryptine being part of the class of ergot derivatives containing medicinal products covered by this procedure is only approved in the above mentioned indications in France and only in combination with caffeine since 1979.
Maltese: Fil-fatt, dihydroergocryptine li huwa parti mill-klassi ta' prodotti mediċinali li fihom derivati tal-ergotina koperti minn din il-proċedura huwa approvat biss fl-indikazzjonijiet imsemmija hawn fuq fi Franza u f'kombinazzjoni biss mal-kafeina sa mill-1979.
English: The Committee concluded that the benefit-risk balance of dihydroergocryptine/caffeine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia) and for ancillary treatment of Raynaud's syndrome.
Maltese: Il-Kumitat ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-bilanċ bejn il-benefiċċju u rriskju tal-prodotti li fihom dihydroergocryptine/kafeina mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja) u għall-kura anċillari tas-sindromu ta' Raynaud.
English: Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: Kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja).
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Maltese: Reviżjoni tad-dejta l-oħra kollha disponibbli (jiġifieri dejta mil-letteratura, dejta pre-klinika, u dejta klinika oħra inkluż studji epidemjoloġiċi) li kienet rilevanti għall-valutazzjoni tar-riskju ta' fibrożi kienet ipprovduta fejn possibbli.
English: These included changing the prescription status, limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Maltese: Dawn kienu jinkludu tibdil fl-istatus tal-preskrizzjoni, li t-tul tal-kura jiġi limitat f'ċerti kundizzjonijiet, il-kontraindikazzjoni tal-prodott f'pazjenti b'fibrożi pre-eżistenti jew f'rabta ma' mediċini oħra, il-ħruġ ta' DHPC li tenfasizza r-riskju, lista ta' kontroll għal min jippreskrivi, u studju farmakoloġiku in vitro għall-affinità tar-riċetturi tas-sottoklassi ta' 5-HT mal-prodott.
English: It is available in combination with caffeine that may improve the digestive absorption of this ergot alkaloid.
Maltese: Huwa disponibbli f'kombinazzjoni mal-kafeina li tista' ttejjeb l-assorbiment diġestiv ta' dan alkalojdi tal-ergotina.
English: Therefore, even if it is highly pharmacologically plausible that ergot derivatives acting as 5HT2B receptor agonists may induce "serotonergic" valve disease similar to that induced by carcinoid tumours or fibrotic lesions of other tissues, it must be remembered that some ergot derivatives are not 5-HT2B receptor agonists.
Maltese: Għalhekk, anke jekk farmakoloġikament huwa plawsibbli ħafna li dderivati tal-ergotina li jaġixxu bħala agonisti tar-riċettur ta' 5-HT2B jistgħu jinduċu mard “serotonerġiku" tal-valvi simili għal dak ikkawżat minn tumuri karċinojdi jew leżjonijiet fibrotiċi ta' tessuti oħra, wieħed għandu jiftakar li xi derivati tal-ergotina mhumiex agonisti tar-riċetturi ta' 5-HT2B.
English: Dihydroergocryptine only containing products are approved in other EU Member States but their indications were not in the scope of this referral procedure (e.g. Parkinson's disease) and were excluded from this review.
Maltese: Prodotti li fihom dihydroergocryptine biss huma approvati fi Stati Membri oħra tal-UE imma l-indikazzjonijiet tagħhom ma kinux fil-kamp ta' applikazzjoni ta' din il-proċedura ta' riferiment (eż. il-marda ta' Parkinson) u kienu esklużi minn din irreviżjoni.
English: Overall summary of the scientific evaluation of dihydroergocryptine/caffeine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom dihydroergocryptine/kafeina (ara Anness I)
English: The clinical efficacy endpoints were numerous and heterogeneous with no defined primary efficacy endpoint.
Maltese: L-endpoints taleffikaċja klinika kienu numerużi u eteroġenji bl-ebda endpoint primarju tal-effikaċja definit.
English: The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Maltese: Ir-relazzjoni bejn il-fibrożi u l-attivazzjoni tar-riċetturi serotonerġiċi, partikularment irriċetturi ta' 5-HT2B minn derivati tal-ergotina ġiet deskritta b'mod estensiv fil-letteratura.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocryptine/caffeine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
Maltese: • Il-Kumitat huwa tal-fehma li l-evidenza ta' effikaċja klinikament sinifikanti ta' dihydroergocryptine/kafeina fl-indikazzjonijiet attwalment ivvalutati hija limitata ħafna, u għalhekk il-benefiċċju potenzjali għall-pazjenti f'dawn l-indikazzjonijiet huwa megħlub mir-riskju identifikat hawn fuq.
English: Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Maltese: B'mod ġenerali, l-affinità varjabbli għar-riċetturi serotonerġiċi bid-derivati differenti tal-ergotina u d-dożi terapewtiċi użati jistgħu jispjegaw id-differenzi osservati fir-rati ta' notifika għar-reazzjonijiet fibrotiċi.
English: There seemed to be a benefit of treatment in approximately 5575% of patients but the CHMP concluded that these results are in fact difficult to interpret from a clinical point of view and not reliable due to the methodological limitations of the studies.
Maltese: F'madwar 55-75% tal-pazjenti kien jidher li hemm benefiċċju tal-kura imma s-CHMP ikkonkluda li minn perspettiva klinika dawn ir-riżultati huma fil-fatt diffiċli biex jiġu interpretati u mhumiex affidabbli minħabba l-limitazzjonijiet metodoloġiċi tal-istudji.
English: This later diagnosis is not any more listed in the DSM-IV-TR.
Maltese: Din id-dijanjosi tal-aħħar m'għadhiex elenkata fid-DSM-IV-TR.
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Maltese: Wara reviżjoni nazzjonali ta' farmakoviġilanza li saret fl-2011, notifiki spontanji ġodda rrapportati b'uħud minn dawk il-prodotti identifikaw każijiet serji ta' fibrożi u ergotiżmu u Franza qieset li dan it-tħassib għas-sigurtà mhuwiex megħlub mill-evidenza limitata ta' effikaċja.
English: Only one study (Vinckier study) mentioned a small group of patients suffering from associated systemic disease.
Maltese: Studju wieħed biss (l-istudju Vinckier) semma grupp żgħir ta' pazjenti li kienu qed ibatu minn mard sistemiku assoċjat.
English: Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis.
Maltese: L-agoniżmu għar-riċetturi ta' 5-HT2B jinduċi rispons proliferattiv u mitoġeniċità taċ-ċelloli li jesprimu dan riċettur li jwassal għal fibroġenesi.
English: Considering the several reported cases of vasoconstriction and the pharmacological structure of this ergot alkaloid derivative product, ergotism cannot be ruled out.
Maltese: Meta wieħed iqis id-diversi każijiet irrapportati ta' vażokostrizzjoni u l-istruttura farmakoloġika ta' dan il-prodott derivat mill-alkalojdi tal-ergotina, lergotiżmu ma jistax jiġi eskluż.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Maltese: Is-serjetà ta' dawn l-effetti avversi u r-riżultat fatali possibbli tagħhom hija enfasizzata.
English: Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis.
Maltese: Id-derivati tal-ergotina huma rikonoxxuti li huma kapaċi jinduċu fibrożi, b'mod partikulari fibrożi talvalvi tal-qalb.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ippreżentaw id-dejta kollha dwar leffikaċja minn provi kliniċi u studji ta' osservazzjoni, inkluża dejta li saret disponibbli wara l-għoti talawtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: In general the CHMP was of the opinion that the methodological flaws and the absence of primary efficacy endpoint do not allow to draw conclusions on clinical efficacy or to support an indication with standardised diagnosis.
Maltese: B'mod ġenerali s-CHMP kien tal-opinjoni li n-nuqqasijiet metodoloġiċi u n-nuqqas ta' endpoint primarju tal-effikaċja ma jippermettux li jinġibdu konklużjonijiet dwar l-effikaċja klinika jew biex jappoġġaw indikazzjoni b'dijanjosi standardizzata.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocryptine/caffeine cannot be excluded.
Maltese: • Il-Kumitat ikkunsidra li rabta kawżali potenzjali bejn ir-reazzjonijiet fibrotiċi jew l-ergotiżmu u dihydroergocryptine/kafeina ma tistax tiġi eskluża.
English: The data from the reported cases of fibrosis (n=3) are limited in order to draw any firm conclusions, however, the risk cannot be excluded considering the improvement observed when dihydroergocryptine/caffeine was discontinued in one of the three reported cases of pulmonary fibrosis occurring with recommended daily dose.
Maltese: Id-dejta mill-każijiet irrapportati ta' fibrożi (n=3) hija limitata sabiex ikunu jistgħu isiru xi konklużjonijiet sodi, madankollu, ir-riskju ma jistax jiġi eskluż meta wieħed iqis it-titjib osservat meta dihydroergocryptine/kafeina twaqqaf f'wieħed mit-tliet każijiet irrapportati ta' fibrożi pulmonari li seħħew bid-doża rakkomandata ta' kuljum.
English: • The variation to the terms of the marketing authorisation for dihydroergocryptine/caffeine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
Maltese: • Il-varjazzjoni fit-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali li fihom dihydroergocryptine/kafeina msemmija fl-Anness I, it-tneħħija tal-indikazzjonijiet ta' hawn taħt mill-Informazzjoni dwar il-Prodott (il-kliem speċifiku tal-indikazzjoni jista' jvarja minn prodott għall-ieħor u minn pajjiż għall-ieħor) kif ukoll kwalunkwe referenza rilevanti għall-dawn lindikazzjonijiet fl-Informazzjoni dwar il-Prodott, meta jkun hemm indikazzjonijiet terapewtiċi oħra approvati bħala parti mill-awtorizzazzjoni għat-tqegħid fis-suq tagħhom:
English: • The Committee considered that the benefit-risk balance of dihydroergocryptine/caffeine containing products: Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: Mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja).
English: Dihydroergocryptine is an ergot alkaloid that has an agonist activity on D2 dopaminergic receptors and a partial agonist activity on D1 receptors.
Maltese: Dihydroergocryptine huwa alkalojdi tal-ergotina li għandu attività agonista fuq ir-riċetturi dopaminerġiċi D2 u attività agonista parzjali fuq ir-riċetturi D1. Fil-firien, dihydroergocryptine wera li jattiva sistemi enzimatiċi antiossidanti fiżjoloġikament mibdula waqt it-tixjiħ.
English: A scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: Fuq talba tas-CHMP f'Diċembru 2012 tlaqqa' grupp konsultattiv xjentifiku (SAG) li matulu l-esperti ddiskutew, abbażi tal-esperjenza klinika tagħhom, jekk din is-sustanza għandhiex rwol fil-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra lmarda ta' Alzheimer u tipi oħra ta' dimenzja).
English: Patients included in most of these studies presented various very different symptoms without standardised diagnosis.
Maltese: Il-pazjenti li ħadu sehem f'ħafna minn dawn l-istudji ppreżentaw bosta sintomi differenti ħafna mingħajr dijanjosi standardizzata.
English: Kolodvorska Cesta 27 1234 Menges Slovenia
Maltese: LEK Pharmaceuticals d.d. Kolodvorska Cesta 27 1234 Menges Slovenia
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Maltese: Żidiet f'lactate dehydrogenase u alkaline phosphatasee1;
English: MedDRA system organ class
Maltese: Klassi tassistemi u talorgani MedDRA
English: Sweet's syndrome
Maltese: Sindrome ta' Sweet
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: .1 Therapeutic indications
English: • Alcohol swab.
Maltese: • Imselħa bl-alkoħol.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see section 4.4).
Maltese: Blood Count] > 100 x 109/L) (ara sezzjoni 4.4).
English: Common (≥ 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa
English: ** The concentration is 20 mg/mL if the PEG moiety is included.
Maltese: ** Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż il-porzjoni PEG.
English: (acute febrile dermatosis)1,2;
Maltese: (dermatożi akuta bid-deni)1,2; Vaskulite fil-ġilda1,2
English: Excipients: glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: glacial acetic acid, sorbitol (E 420), polysorbate 20, sodium hydroxide, ilma għallinjezzjonijiet.
English: Ziextenzo 6 mg injection pegfilgrastim SC
Maltese: Ziextenzo 6 mg injezzjoni pegfilgrastim SC
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi frigg (2°C-8°C).
English: StevensJohnson syndrome
Maltese: StevensJohnson
English: See section 2 “Ziextenzo contains sorbitol (E420) and sodium”.
Maltese: Ara sezzjoni 2 “Ziextenzo fih sorbitol (E 420) u sodium”.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Distress Respiratorju Akut (ARDS - Acute Respiratory Distress Syndrome).
English: Store in the refrigerator between 2 °C and 8 °C.
Maltese: Aħżen fil-friġġ f'temperatura bejn 2°C sa 8°C.
English: Ziextenzo 6 mg injection pegfilgrastim
Maltese: Ziextenzo 6 mg injezzjoni pegfilgrastim
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' Ziextenzo.
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: Ziextenzo contains sorbitol (E420) and sodium
Maltese: Ziextenzo fih sorbitol (E 420) u sodium.
English: Ziextenzo is a biosimilar medicinal product.
Maltese: Ziextenzo huwa prodott mediċinali bijoloġiku simili.
English: Ziextenzo contains the active substance pegfilgrastim.
Maltese: Ziextenzo fih is-sustanza attiva pegfilgrastim.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 mcg/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: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG).
English: Ziextenzo is for use in adults aged 18 and over.
Maltese: Ziextenzo huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: How to store Ziextenzo
Maltese: Tużax Ziextenzo
English: Transient elevations in LFT's for ALT or
Maltese: Żidiet temporanji flLFT's għal ALT jew
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (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: (47.9 ± 22.5 µg siegħa/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 siegħa/ml, rispettivament) (ara sezzjoni 5.1).
English: • coughing up blood (haemoptysis)
Maltese: • sogħla tad-demm (emoptiżi).
English: - The other ingredients are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide and water for injections.
Maltese: - Is-sustanzi nhux attivi l-oħra huma glacial acetic acid, sorbitol (E 420), polysorbate 20 sodium hydroxide u ilma għall-injezzjoni.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Maltese: Rati ta' produzzjoni ta' antikorpi kontra pegfilgrastim huma ġeneralment baxxi.
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: 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: doxorubicin u cyclophosphamide (VAdriaC/IE), kien osservat tul itwal ta' newtropenija severa (newtrofili < 0.5 x 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: 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 trattati b'kimoterapija wara injezzjoni waħda ta' 6 mg
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 listudju 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: 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 filpulmun, infiltrati filpulmun u fibrosi filpulmun)
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 kinitx osservata fi provi kliniċi randomised u kkontrollati f'adulti.
English: • think you may be pregnant; or
Maltese: • taħseb li tista' tkun tqila; jew
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: ġie rrappurtat 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.