FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/145600/2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United
English: The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.
Maltese: Is-sustanza attiva f'dawn il-mediċini tista' tkun valproic acid, magnesium valproate, sodium valproate, valproate semisodium jew valpromide.
English: The review of valproate medicines was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' mediċini li fihom valproate nbeda fid-9 ta' Marzu 2017 fuq talba tar-regolatur tal-mediċini Franċiż ANSM, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Maltese: Il-mediċini li fihom valproate jintużaw biex jikkuraw epilessija u disturb bipolari.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE), lill-Iżlanda, lilLiechtenstein u lin-Norveġja.
English: Member State representatives agree new restrictions and pregnancy prevention programme
Maltese: Ir-rappreżentanti tal-Istati Membri jaqblu dwar restrizzjonijiet ġodda u programm għall-prevenzjoni fit-tqala
English: During the review, the PRAC also consulted very widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including healthcare professionals, patients organisations, patients and their families), and via a public hearing.
Maltese: Waqt ir-rieżami, ilPRAC ikkonsulta wkoll ħafna mal-professjonisti fil-qasam tal-kura tas-saħħa u mal-pazjenti, inklużi nisa u t-tfal tagħhom li ġew affettwati mill-użu ta' valproate waqt it-tqala, permezz ta' preżentazzjonijiet bil-miktub, laqgħat ma' esperti, laqgħat ma' partijiet ikkonċernati (inklużi professjonisti fil-qasam talkura tas-saħħa, organizzazzjonijiet tal-pazjenti, pazjenti u l-familji tagħhom), u permezz ta' seduta pubblika.
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Maltese: Il-mediċini li fihom valproate ġew awtorizzati permezz ta' proċeduri nazzjonali fl-Istati Membri kollha tal-UE u fin-Norveġja u fl-Iżlanda.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillGrupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati - Bniedem (CMDh), li adotta pożizzjoni.
English: • Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine.
Maltese: • Il-mediċini li fihom valproate ilhom disponibbli fil-pajjiżi tal-UE għal bosta snin biex jikkuraw epilessija, disturb bipolari u f'xi pajjiżi emigranja.
English: A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
Maltese: Fuq l-imballaġġ tal-mediċini għandha titqiegħed ukoll twissija viżwali tar-riskji fit-tqala (fil-forma ta' kitba ġo kaxxa b'elementi oħra possibbli bħal simbolu ta' twissija) u t-twissijiet għandhom jiġu inklużi fuq il-kards tal-pazjenti mehmuża mal-kaxxa u forniti mal-mediċina kull darba li tingħata.
English: • As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty.
Maltese: • Bħal qabel, kura b'valproate m'għandha qatt tibda sakemm kuri alternattivi ma jkunux xierqa, inkluż fi tfajliet taħt l-età tal-pubertà.
English: Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.
Maltese: Il-mediċini li fihom valproate ġew approvati b'mod nazzjonali fl-UE biex jikkuraw l-epilessija u disturb bipolari u f'xi pajjiżi għall-prevenzjoni tal-emigranja.
English: • In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation, for women planning pregnancy; however, there may be a small number of women with epilepsy for whom there is no suitable alternative treatment to valproate and who should be appropriately supported and counselled.
Maltese: • Fit-tqala, valproate huwa kontraindikat u għandha tiġi deċiża kura alternattiva, b'konsultazzjoni speċjalista xierqa, għal nisa li jkunu qegħdin jippjanaw tqala; madankollu, jaf ikun hemm numru żgħir ta' nisa b'epilessija li għalihom m'hemm l-ebda kura alternattiva xierqa għal valproate u li għandhom jiġu appoġġjati u kkonsultati kif xieraq.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Dan huwa responsabbli biex jiżgura standards armonizzati dwar is-sigurtà għall-mediċini awtorizzati permezz tal-proċeduri nazzjonali madwar l-UE kollha.
English: − counselling about the risks of valproate treatment and the need for effective contraception throughout treatment,
Maltese: konsulenza dwar ir-riskji ta' kura b'valproate u l-ħtieġa għal kontraċezzjoni effettiva matul ilkura,
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp li jirrappreżenta l-Istati Membri tal-UE kif ukoll l-Iżlanda, ilLiechtenstein u n-Norveġja.
English: • Valproate medicines are now therefore contraindicated, i.e. must not be used, in girls and women able to have children unless the terms of a special pregnancy prevention programme are followed.
Maltese: • Għalhekk il-mediċini li fihom valproate huma kontraindikati, jiġifieri m'għandhomx jintużaw, fittfajliet u fin-nisa li jistgħu jkollhom it-tfal sakemm ma jiġux segwiti t-termini ta' programm għallprevenzjoni fit-tqala speċjali.
English: More about the medicine
Maltese: Aktar dwar il-mediċina
English: The CMDh1 has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.
Maltese: Fil-21 ta' Marzu 2018 is-CMDh1 approva miżuri ġodda sabiex jiġi evitat l-esponiment tat-trabi għal mediċini li fihom valproate fl-utru, minħabba li trabi esposti jinsabu f'riskju għoli ta' malformazzjonijiet u problemi tal-iżvilupp.
English: The CMDh agreed with EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures, that despite previous recommendations aimed at better informing patients of the risks with these medicines, women were still not always receiving the right information in a timely manner.
Maltese: Barra minn hekk, il-mediċini m'għandhomx jintużaw f'xi mara jew tfajla li jista' jkollha t-tfal sakemm ma jiġux issodisfati l-kondizzjonijiet ta' programm ġdid għall-prevenzjoni fit-tqala.
English: New measures to avoid valproate exposure in pregnancy endorsed
Maltese: Aktar dwar il-proċedura
English: It also includes a retrospective observational study to look at any association between exposure to valproate in men and the risk of malformations and developmental disorders including autism in offspring, and an observational study to evaluate and identify the best practice for stopping and switching of valproate treatment.
Maltese: Il-miżuri huma bbażati fuq rieżami tal-evidenza xjentifika disponibbli, inklużi studji dwar l-użu magħmul mill-mediċina u evidenza klinika u tal-laboratorju tal-effetti tal-mediċina.
English: Figure 1.
Maltese: Figura 1.
English: 45 minutes
Maltese: 45 minuta
English: Step 1: Prepare
Maltese: Pass 1: Preparazjoni
English: Attention!
Maltese: Attenzjoni!
English: Puerto Rico 00777-4060 USA
Maltese: Puerto Rico 00777-4060
English: See also section 4.8.
Maltese: Ara sezzjoni 4.8.
English: Common (≥ 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: Activity
Maltese: Attività
English: Important
Maltese: Importanti
English: 0% (empty)
Maltese: 0% (vojt)
English: 9/L) have been reported (see section 4.4).
Maltese: 9/L) (ara sezzjoni 4.4).
English: MedDRA system organ class
Maltese: Klassi tas-sistemi u tal-organi MedDRA
English: Sweet's syndrome (acute febrile dermatosis)1,2
Maltese: Sindrome ta' Sweet (dermatożi akuta bid-deni)1,2;
English: Neulasta contains sorbitol.
Maltese: Neulasta fih sorbitol.
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: • Only expose the on-body injector to temperatures between 5°C - 40°C.
Maltese: • Esponi l-injettatur li jeħel mal-ġisem għal temperaturi bejn 5°C - 40°C biss.
English: Watch for at least 10 seconds.
Maltese: Osserva għal mill-inqas 10 sekondi.
English: Pulmonary adverse events
Maltese: Avvenimenti avversi pulmonari
English: Luxembourg/Luxemburg s.a. Amgen
Maltese: Luxembourg/Luxemburg s.a.
English: Very rare
Maltese: Rari sa
English: 100% (full)
Maltese: 100% (mimli)
English: • alcohol wipes or similar.
Maltese: • imsielaħ tal-alkoħol jew simili.
English: Uncommon (≥ 1/1,000 to
Maltese: Mhux komuni (≥ 1/1,000 sa
English: - The active substance is pegfilgrastim.
Maltese: - Is-sustanza attiva hi pegfilgrastim.
English: Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably wet (saturated) adhesive.
Maltese: Nota: Huwa normali li tara ftit qtar ta' fluwidu fis-sit tal-applikazzjoni, iżda mhux normali li tara lparti li teħel imxarrba ħafna (saturata).
English: Aortitis
Maltese: Aortite
English: Pulmonary haemorrhage
Maltese: Emorraġija pulmonari
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Maltese: Kategorija farmakoterapewtika: immunostimulanti, fattur li jistimula l-kolonji, Kodiċi ATC:
English: Glomerulonephritis
Maltese: Glomerulonefrite
English: Dermatitis contact
Maltese: Dermatite talkuntatt
English: StevensJohnson syndrome
Maltese: Sindrome ta' StevensJohnson
English: Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Maltese: Amgen NV Telecomlaan 5-7 1831 Diegem Il-Belġju
English: België/Belgique/Belgien s.a. Amgen n.v.
Maltese: België/Belgique/Belgien s.a.
English: EU/1/02/227/001 - 1 pack EU/1/02/227/004 - 1 pack with needle guard EU/1/02/227/005 - 1 pack with on-body injector
Maltese: EU/1/02/227/001 - pakkett wieħed EU/1/02/227/004 - pakkett wieħed b'għatu ta' protezzjoni tal-labra EU/1/02/227/005 - pakkett wieħed b'injettatur li jeħel mal-ġisem
English: Neulasta contains sorbitol (E420) and sodium acetate
Maltese: Neulasta fih sorbitol (E420) u sodium acetate
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Maltese: Manifattur Amgen NV Telecomlaan 5-7 1831 Diegem Il-Belġju
English: ANNEX IV
Maltese: ANNESS IV
English: EU/1/02/227/001 - 1 pack blistered syringe EU/1/02/227/002 - 1 pack unblistered syringe EU/1/02/227/004 - 1 pack blistered syringe with needle guard EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector
Maltese: EU/1/02/227/001 - pakkett ta' siringa waħda f'folja EU/1/02/227/002 - pakkett ta' siringa waħda mhux fil-folja EU/1/02/227/004 - pakkett ta' siringa waħda b'għatu ta' protezzjoni tal-labra f'folja EU/1/02/227/005 - pakkett ta' siringa waħda f'folja flimkien ma' injettatur li jeħel mal-ġisem f'folja
English: NL-4817 ZK Breda The Netherlands
Maltese: NL-4817 ZK Breda L-Olanda
English: Elevations in uric acid
Maltese: Żidiet fil-uric acid
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Maltese: Pegfilgrastim huwa proteina magħmula permezz talbijoteknoloġija f'batterja msejħa E. coli.
English: Rare to
Maltese: Rari ħafna
English: - Radiation treatment.
Maltese: - Trattament ta' radjazzjoni.
English: • bleeding from the lung (pulmonary haemorrhage).
Maltese: • fsada mill-pulmun (emorraġija pulmonari).
English: Immunogenicity
Maltese: Immunoġeniċità
English: The concentration is 10 mg/mL based on protein only**.
Maltese: Ilkonċentrazzjoni hija ta' 10 mg/mL ibbażata fuq il-proteina biss**.
English: 4817 ZK Breda The Netherlands
Maltese: 4817 ZK Breda L-Olanda
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
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-metHuG-CSF - recombinant human G-CSF) marbut b'rabta kovalenti ma' molekola waħda ta' polyethylene glycol (PEG) ta' 20 kd.
English: • Keep the on-body injector at least 10 cm (4 inches) away from electrical equipment such as mobile phones, cordless telephones, microwaves and other common appliances.
Maltese: • Żomm l-injettatur li jeħel mal-ġisem mill-inqas 10 ċm (4 pulzieri) bogħod minn tagħmir elettriku bħal telefons ċellulari, telefons bla fili, microwaves u apparat komuni ieħor.
English: Other medicines and Neulasta
Maltese: Mediċini oħra u Neulasta
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: Instructions for use:
Maltese: Instruzjonijiet għall-użu:
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 10
Maltese: Kienu rrappurtati każijiet komuni ta' lewkoċitosi (Għadd ta' Ċelluli bojod tad-Demm [WBC - White Blood Count] > 100 x 10
English: • The on-body injector contains batteries, electronics, and a needle.
Maltese: • L-injettur li jeħel mal-ġisem fih batteriji, elettroniċi, u labra.
English: The least-squares geometric mean ratios (90% CIs) (on-body injector to manual injection) were 0.97 (0.83, 1.14) for Cmax and 1.00 (0.84, 1.20) for AUC0-inf within the pre-specified bioequivalence limit of 0.80 to 1.25, and established bioequivalence between the two delivery methods of a single 6 mg dose of pegfilgrastim.
Maltese: Ilproporzjonijiet ġeometriċi medji ta' least-squares (CIs ta' 90%) (injettatur li jeħel mal-ġisem imqabbel ma' injezzjoni manwali) kienu 0.97 (0.83, 1.14) għal Cmax u 1.00 (0.84, 1.20) għal AUC0-inf fil-limitu ta' bijoekwivalenza speċifikat minn qabel ta' 0.80 sa 1.25, u stabbilizzaw bijoekwivalenza bejn iżżewġ metodi ta' għoti ta' doża waħda ta' 6 mg ta' pegfilgrastim.
English: Date of first authorisation: 22 August 2002 Date of latest renewal: 16 July 2007
Maltese: Data tal-aħħar tiġdid: 16 ta' Lulju 2007
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 talplaċebo (1% versus 14%, p < 0.001; u 2% versus 10%, p < 0.001).
English: Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Maltese: Eċċipjenti: sodium acetate, sorbitol (E420), polysorbate 20, ilma għall-injezzjonijiet.
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: 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). Bleċċezzjoni tal-grupp tal-iżgħar età (0-5 snin), l-AUC medja f'individwi pedjatriċi deheret simili għal dik ta' pazjenti adulti b'kanċer tas-sider ta' fażi
English: Medicine
Maltese: Mediċina
English: Median Absolute Neutrophil Count (cells x 109/l)
Maltese: Medjan ta' l-Għadd Assolut ta' Newtrofili (ċelluli X 109/l)
English: Neulasta contains the active substance pegfilgrastim.
Maltese: Neulasta fih is-sustanza attiva Pegfilgrastim.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Dan jista' jkun sinjal ta' Sindrome ta' Distress Respiratorju Akut (ARDS - Acute Respiratory Distress Syndrome).
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilita, tqala u treddigħ
English: *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: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva
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: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Maltese: Respiratorju Akut2; Reazzjonijiet avversi relatati malpulmun (pulmonite tal-interstizju, edima fil-pulmun, infiltrati fil-pulmun u fibrosi filpulmun);
English: • coughing up blood (haemoptysis).
Maltese: • sogħla tad-demm (emoptiżi).
English: Excipients with known effect Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4).
Maltese: Kull siringa mimlija għal-lest fiha 30 mg sorbitol (E-420) (ara sezzjoni 4.4).
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 10
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 x 10
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol (23 mg) sodium f'kull doża ta' 6 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' Neulasta.
English: See also section 2.
Maltese: Ara wkoll sezzjoni 2.
English: Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity.
Maltese: Waqqaf pegfilgrastim b'mod permanenti f'pazjenti li jkollhom sensittività eċċessiva klinikament sinifikanti.
English: Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), 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: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Maltese: Sindrome ta' Stevens-Johnson (SJS), li tista' tkun ta' periklu għall-ħajja jew fatali, ġiet irrappurtata b'mod rari f'assoċjazzjoni ma' trattament b'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 mcg/kg pegfilgrastim wara li temmew kimoterapija VAdriaC/IE.
English: On-body injector, the fluid path is made from polypropylene, cyclic olefin copolymer, silicone rubber and fluorinated ethylene propylene (FEP), with a stainless steel 28 gauge needle.
Maltese: Injettatur li jeħel mal-ġisem, il-mogħdija tal-fluwidu hija magħmula minn polypropylene, cyclic olefin copolymer, lastiku silicone u fluorinated ethylene propylene (FEP), b'labra tal-azzar li ma jissaddadx b'kejl ta' 28 gauge.
English: See section 2.
Maltese: Ara sezzjoni 2.
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving Neulasta in nine randomised clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata minn kalkolu statistiku bbażat fuq 1,576 pazjent li kienu qed jirċievu Neulasta f'disa' provi kliniċi randomised.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal fil-każ ta' fatturi ta' tkabbir ematopoetiku oħra, G-CSF wera kwalitajiet stimulanti in vitro fuq ċelluli tal-endotelju uman.
English: Pull straight as shown in pictures 1 and 2.
Maltese: Iġbed dritt kif muri fi stampi 1 u 2.
English: • You may hear a series of clicks.
Maltese: • Tista' tisma sensiela ta' klikks.
English: Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Amgen Europe B.V.
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Maltese: Rati ta' produzzjoni ta' antikorpi kontra pegfilgrastim huma ġeneralment baxxi.
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: Plunger
Maltese: Planġer
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 is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
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: • Remove any extra adhesive using soap and water.
Maltese: • Neħħi kwalunkwe kolla żejda bl-użu ta' sapun u ilma.
English: Neulasta is for use in adults aged 18 and over.
Maltese: Neulasta huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: Avoid vigorous shaking.
Maltese: Evita li tħawwad iż-żejjed.