FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematopoietic recovery following PBPC infusion was similar between patients who received Kepivance or placebo, and there were no observed differences in disease progression or survival.
Maltese: L-irkupru ematopojetiku wara infużjoni b'PBPC kien simili bejn pazjenti li rċivew Kepivance jew plaċebo, u ma kienet osservata l-ebda differenza fil-progressjoni tal-marda jew fis-sopravivenza.
English: Haematologic malignancies do not express the KGF receptor.
Maltese: Hu magħruf li riċetturi għal KGF huma espressi fil-lenti tal-għajn.
English: As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Bħala proteina terapewetika, ir-riskju li Kepivance ma jaqbilx ma' prodotti mediċinali oħra huwa baxx.
English: Dysgeusia Paraesthesia oral
Maltese: Indeboliment fis-sens tat-togħma Parestesija orali
English: In embryo/foetal development toxicity studies in rats and rabbits, palifermin treatment was associated with developmental toxicity (increased post-implantation loss, reduced litter size, and/or reduced foetal weight) at doses of 500 and 150 micrograms/kg/day, respectively.
Maltese: Fi studji dwar it-tossiċità fuq l-embriju u fuq l-iżvilupp tal-fetu fil-firien u fniek, kura b'palifermin kienet assoċjata ma' tossiċità fuq l-iżvilupp (żieda fit-telf wara l-impjantazzjoni, boton ta' daqs imnaqqas, u/jew tnaqqis fil-piż tal-fetu) f'dożi ta' 500 u 150 mikrogramma/kg/kuljum, rispettivament.
English: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support.
Maltese: Kepivance huwa indikat biex inaqqas l-inċidenza, it-tul u s-severità ta' mukosite orali f'pazjenti adulti b'tumuri ematoloġiċi malinni li qed jirċievu terapija mijeloablattiva assoċjata ma' inċidenza għolja ta' mukosite severa u li teħtieġ appoġġ ta' ċelluli staminali emopojetiċi tal-pazjent innifsu.
English: Days
Maltese: JIS
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: • tingling of the mouth;
Maltese: • uġigħ;
English: Non-haematological malignancies
Maltese: TAL-PRODOTT MEDIĊINALI
English: • skin rash, itching and redness (pruritus and erythaema);
Maltese: • ħmura, ponot jew nefħa fl-ilsien;
English: Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology
Maltese: Palifermin huwa fattur tat-tkabbir tal-keratinoċiti (KGF) uman, magħmul minn teknoloġija ta' DNA
English: In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis.
Maltese: Fi prova klinika, l-għoti ta' Kepivance sa 24 siegħa mill-kimoterapija wasslet għal żieda fis-severità u t-tul tal-mukosite orali.
English: • lip swelling.
Maltese: - Żomm dan il-fuljett.
English: Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms.
Maltese: Kepivance jintuża biex inaqqas il-frekwenza, it-tul u-severità tas-sintomi ta' mukożite orali.
English: Hypersensitivity, including Anaphylactic reactions, has also been associated with palifermin.
Maltese: Sensittività eċċessiva, li tinkludi reazzjonijiet anafilattiċi, kienet assoċjata wkoll ma' palifermin.
English: There is no experience with Kepivance doses greater than 80 micrograms/kg/day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative
Maltese: Ma hemmx esperjenza b'dożi ta' Kepivance ta' aktar minn 80 mikrogramma/kg/kuljum mogħti ġolvini f'pazjenti fuq perjodu ta' ġimagħtejn (3 dożi qabel u 3 dożi wara t-terapija mijeloablattiva).
English: The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses.
Maltese: Id-dożaġġ rakkomandat ta' Kepivance huwa ta' 60 mikrogramma/kg/kuljum, mogħti bħala injezzjoni bolus ġol-vini għal tlett ijiem konsekuttivi qabel u tlett ijiem konsekuttivi wara radjokemoterapija mijeloablattiva għal total ta' sitt dożi.
English: Each vial contains 6.25 mg of palifermin.
Maltese: Kull kunjett fih 6.25 mg ta' palifermin.
English: • swelling (oedema) of the face or mouth;
Maltese: • ħakk u ħmura (ħakk u eritema);
English: No gender-related differences were observed in the pharmacokinetics of palifermin.
Maltese: Ma kienet osservata l-ebda differenza relatata mas-sess tal-persuna fil-farmakokinetika ta' palifermin.
English: A randomised, placebo-controlled, double-blind study was conducted post-approval to evaluate the efficacy of palifermin given pre- or pre- and post- chemotherapy (CT).
Maltese: Studju randomiżżat u bl-għama doppju kkontrollat minn placebo sar wara l-approvazzjoni sabiex tiġi evalwata l-effikaċja tal-palifermin mogħti qabel jew qabel u wara l-kimoterapija (KT).
English: In this study, 212 patients were randomised and received either palifermin or placebo.
Maltese: F'dan l-istudju, 212-il pazjent kienu randomised u rċivew palifermin jew plaċebo.
English: Kepivance is not recommended in children (0 to 18 years).
Maltese: Kepivance mhuwiex rakkomandat fit-tfal (minn 0 sa 18-il sena).
English: Oral mucositis and related clinical sequelae - HSC transplant study Palifermin (60 micrograms/kg/day) n = 106
Maltese: Effetti sekondarji komuni ħafna (jaffettwaw iktar minn utent 1 minn kull 10) huma:
English: Rash, pruritus and erythema Skin hyperpigmentation Palmar-plantar erythrodysaesthesia syndrome (dysaesthesia, erythema, oedema on the palms and soles)
Maltese: Jekk eparina tintuża biex jinżamm pajp ġol-vina, għandha tintuża soluzzjoni ta' sodium chloride biex jitlaħlaħ il-pajp qabel u wara l-għoti ta' Kepivance, minħabba li palifermin intwera li jeħel mal-eparina in vitro.
English: However, patients treated with chemotherapy and/or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands.
Maltese: Kepivance huwa fattur tat-tkabbir li jistimula l-proliferazzjoni ta' ċelluli tal-epitilju li jesprimu riċettur għal KGF.
English: Alopecia$
Maltese: Alopeċja$
English: Research Triangle Park, NC 27709-4627 USA
Maltese: Research Triangle Park, NC 27709-4627 L-Istati Uniti tal-Amerika
English: 1171 LP Badhoevedorp The Netherlands
Maltese: 1171 LP Badhoevedorp In-Netherlands
English: 250 Binney Street Cambridge, MA 02142 USA
Maltese: 250 Binney Street Cambridge, MA 02142 L-Istati Uniti tal-Amerika
English: (See Figure H).
Maltese: (Ara Figura H).
English: Day 28
Maltese: Jum 28
English: 17% previously treated
Maltese: 17% ikkurati fil-passat
English: Mean age (years)
Maltese: Medja ta' età (snin)
English: Day 0 (63 micrograms)
Maltese: Jum 0 (63 mikrogramma)
English: Table 3: Clinical and MRI results
Maltese: Tabella 3: Riżultati kliniċi u MRI
English: Day 14 (94 micrograms)
Maltese: Jum 14 (94 mikrogramma)
English: It is important to continue using Plegridy regularly.
Maltese: Hu importanti li tkompli tuża Plegridy b'mod regolari.
English: *Class label for interferon beta products (see section 4.4).
Maltese: * Tikketta tal-klassi għal prodotti beta interferon (ara sezzjoni 4.4)
English: Date of first authorisation: 18 July 2014 Date of latest renewal: 25 March 2019
Maltese: Data tal-aħħar tiġdid: 28 Marzu 2019
English: - Depression
Maltese: - Depressjoni
English: Day 0
Maltese: Jum 0
English: Amount (micrograms)
Maltese: Ammont (mikrogrammi)
English: See section 4 for the symptoms of an allergic reaction.
Maltese: Ara sezzjoni 4 għas-sintomi ta' reazzjoni allerġika.
English: Dose 1
Maltese: Doża 1
English: Gamma-glutamyltransferase increased
Maltese: Żieda f'gamma glutamyltransferase
English: Clinical experience in patients aged above 65 years is limited.
Maltese: L-esperjenza klinika f'pazjenti ta' iktar minn 65 sena hi limitata.
English: Biogen Belgium NV/SA
Maltese: België/Belgique/Belgien Biogen Belgium NV/SA
English: 3 years.
Maltese: 30 jum.
English: Dose 3
Maltese: Doża 3
English: Initiation Pack
Maltese: Liema pakkett
English: Clear and colourless solution with pH 4.5-5.1.
Maltese: Soluzzjoni ċara u bla kulur soluzzjoni b'pH ta' 4.5-5.1.
English: See section 6.3 for additional information on storage at room temperature.
Maltese: Ara sezzjoni 6.3 għal informazzjoni addizzjonali fuq il-ħażna f't-temperatura ambjentali.
English: Dose 2
Maltese: Doża 2
English: Each inner carton contains 2 pens in a protective plastic tray.
Maltese: Kull kartuna ta' ġewwa fiha 2 pinen fi trej protettiv tal-plastik.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1, 000 to <1/100) Rare (≥1/10, 000 to <1/1,000)
Maltese: Rari (≥1/10,000 sa <1/1,000)
English: • 1 Plegridy Pen (see Figure A)
Maltese: • 1 Pinna ta' Plegridy (ara Figura A)
English: Plegridy is interferon beta-1a conjugated to a single, linear 20 kDa methoxy poly(ethyleneglycol) molecule at the alpha-amino group of the N-terminal amino acid residue.
Maltese: Plegridy hu interferon beta-1a konjugat għal molekula lineari waħda, 20 kDa methoxy poly(ethyleneglycol) fil-grupp alpha-amino tar-residwu tal-N-terminal tal-amino acid.
English: P-value p≤0.0001
Maltese: valur p p≤0.0001
English: EU/1/14/934/001 EU/1/14/934/002 EU/1/14/934/003 EU/1/14/934/004 EU/1/14/934/005 EU/1/14/934/006
Maltese: EU/1/14/934/002 EU/1/14/934/003 EU/1/14/934/004
English: 63 micrograms, choose orange syringe
Maltese: 63 mikrogramma, agħżel pinna oranġjo
English: Neutralising antibodies have the potential to reduce clinical efficacy.
Maltese: Antikorpi newtralizzanti għandhom ilpotenzjal li jnaqqsu l-effikaċja klinika.
English: Three percent of patients (18/681) developed persistent antibodies to the PEG moiety of peginterferon beta-1a.
Maltese: Tlieta fil-mija tal-pazjenti (18/681) żviluppaw antikorpi persistenti għall-PEG moiety ta' peginterferon beta-1a.
English: The incidence of potentially clinically significant decreases in RBC counts (<3.3 x 1012/L) was similar in Plegridy-treated patients compared to placebo-treated patients.
Maltese: Linċidenza ta' tnaqqis potenzjalment klinikament sinifikanti fl-għadd ta' RBC (<3.3 x 1012/L) kienet simili f'pazjenti kkurati bi Plegridy meta mqabbla ma' pazjenti kkurati bi plaċebo.
English: The incidence of potentially clinically significant decreases in lymphocyte counts (<0.5 x 109/L) (<1%), neutrophil counts (≤1.0 x 109/L) (<1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in Plegridy-treated patients compared to placebotreated patients.
Maltese: L-inċidenza ta' tnaqqis potenzjalment klinikament sinifikanti fl-għadd tal-limfoċiti (<0.5 x 109/L) (<1%), għadd tan newtrofili (≤1.0 x 109/L) (<1%) u fl-għadd tal-plejtlits (≤100 x 109/L) (≤1%) kienet simili f'pazjenti kkurati bi Plegridy meta mqabbla ma' pazjenti kkurati bi plaċebo.
English: *The active substance, peginterferon beta-1a, is a covalent conjugate of interferon beta-1a, produced in Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) using an O-2-methylpropionaldehyde linker.
Maltese: *Is-sustanza attiva, peginterferon beta-1a, hi konjugata kovalenti ta' interferon beta-1a, magħmul fiċċelluli tal-ovarji tal-ħamster Ċiniż, b'20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) bl-użu ta' O-2-methylpropionaldehyde linker.
English: 1512 patients were randomised to and dosed with 125 micrograms Plegridy injected subcutaneously every 2 (n=512) or 4 (n=500) weeks versus placebo (n=500).
Maltese: Plegridy u ngħataw 125 mikrogramma ta' Plegridy injettat taħt il-ġilda kull ġimagħtejn (n=512) jew 4 (n=500) ġimgħat kontra plaċebo (n=500).
English: 92% ≥9 T2 lesions baseline 16% EDSS ≥4
Maltese: 38% mill-inqas 1 leżjoni Gd+ fil-linja bażi 92% ≥9 leżjonijiet T2 fil-linja bażi 16% EDSS ≥4
English: This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).
Maltese: Dan għandu jiġi kkunsidrat meta taqleb pazjenti bejn pegylated u non-pegylated interferons (ara sezzjoni 5.1).
English: Plegridy 125 mcg injection peginterferon beta-1a SC
Maltese: Plegridy 125 mcg injezzjoni peginterferon beta-1a SC
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Maltese: Każijiet ta' sindrome nefrotiku b'nefropatiji sottostanti differenti li jinkludu glomerulosklerożi segmentali fokali li tikkollassa (FSGS), marda ta' bidla minima (MCD), glomerulonefrite membranoproliferattiva (MPGN) u glomerulopatija membranuża (MGN) ġew irrappurtati matul ilkura bi prodotti li fihom interferon-beta.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Maltese: • Il-ħażna rakkomandata hi refriġerazzjoni kkontrollata f'temperatura ta' 2°C sa 8°C fil-kartuna oriġinali magħluqa sabiex tilqa' mid-dawl.
English: Choose the correct syringe from a pack.
Maltese: Agħżel is-siringa korretta minn pakkett.
English: Data from patients treated up to 2 years with Plegridy suggests that less than 1% (5/715) developed persistent-neutralising antibodies to the interferon beta-1a portion of peginterferon beta-1a.
Maltese: Dejta minn pazjenti kkurati sa sentejn bi Plegridy tissuġġerixxi li inqas minn 1% (5/715) żviluppaw antikorpi persistenti-newtralizzanti għall porzjon ta' interferon beta-1a ta' peginterferon beta-1a.
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Maltese: Kategorija ta' frekwenza tinkludi purpura tromboċitopenika trombotika/sindrome uremiku emolitiku*
English: Plegridy 63 mcg injection Plegridy 94 mcg injection peginterferon beta-1a SC
Maltese: Plegridy 63 mcg injezzjoni Plegridy 94 mcg injezzjoni peginterferon beta-1a SC
English: The pack contains 3 inner cartons.
Maltese: Il-pakkett fih 3 kartuni ta' ġewwa.
English: In multiple sclerosis patients, the t1/2 (mean±SE) of peginterferon beta-1a was 78 ± 15 hours at steady state.
Maltese: F'pazjenti bi sklerożi multipla, it-t1/2 (medja±SE) ta' peginterferon beta-1a kienet ta' 78 ± 15-il siegħa fl-istat fiss.
English: Biological effects that may be mediated by Plegridy include up-regulation of anti-inflammatory cytokines (e.g. IL-4, IL-10, IL-27), down-regulation of pro-inflammatory cytokines (e.g. IL-2, IL-12, IFN-γ, TNF-α) and inhibiting the migration of activated T cells across the blood brain barrier; however additional mechanisms may be involved.
Maltese: L-effetti bijoloġiċi li jistgħu jkunu medjati minn Plegridy jinkludu regolazzjoni 'l fuq ta' cytokines antiinfjammatorji (eż. IL-4, IL-10, IL-27), regolazzjoni 'l isfel ta' cytokines proinfjammatorji (eż. IL-2, IL-12, IFN-γ, TNF-α) u li jinibixxu l-migrazzjoni ta' ċelluli T attivati mill barriera bejn id-demm u l-moħħ; madankollu mekkaniżmi addizzjonali jistgħu jkunu involuti.
English: Plegridy contains sodium
Maltese: Plegridy fih is-sodium
English: Subcutaneous peginterferon beta-1a resulted in approximately 4-, 9-, and 13-fold higher exposure (AUC168h) values and approximately 2-, 3.5- and 5-fold higher Cmax, following single doses of 63 (6 MIU), 125 (12 MIU), and 188 (18 MIU) micrograms respectively, compared to intramuscular administration of 30 (6 MIU) micrograms non-pegylated beta-1a.
Maltese: 4, 9, u 13-il darba aktar (AUC168h), u Cmax madwar 2, 3.5 u 5 darbiet ogħla, wara dożi waħidhom ta' 63 (6MIU), 125 (12MIU), u 188 (18 MIU) mikrogramma rispettivament, meta mqabbla mal-għoti ġolmuskoli ta' 30 (6MIU) mikrogramma ta' non-pegylated beta-1a.
English: Direct comparative data for Plegridy versus non-pegylated interferon beta or data on efficacy of Plegridy after switching from a non-pegylated interferon beta are not available.
Maltese: Dejta diretta u komparattiva għal Plegridy kontra non-pegylated interferon beta jew dejta dwar l-effikaċja ta' Plegridy wara l-qlib minn non-pegylated interferon beta mhijiex disponibbli.
English: Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Maltese: Plegridy huwa indikat f'pazjenti adulti għall-kura ta' sklerożi multipla li tirkadi u tbatti (ara sezzjoni 5.1).
English: The active ingredient is peginterferon beta-1a.
Maltese: Is-sustanza attiva hi peginterferon beta-1a.
English: Solution for injection Multipack: 6 (3 packs of 2) pre-filled pens of 125 micrograms.
Maltese: Soluzzjoni għall-injezzjoni Pakkett multiplu: 6 (3 pakketti ta' 2) pinen mimlija għal-lest ta' 125 mikrogramma.
English: A definitive mechanism of action of peginterferon beta-1a in multiple sclerosis (MS) is not known.
Maltese: Mekkaniżmu ta' azzjoni definittiv ta' peginterferon beta-1a fi sklerożi multipla (MS) mhuwiex magħruf.
English: Plegridy is an interferon beta-1a conjugated with a single, linear molecule of 20,000 Da methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde (20 kDa mPEG-O-2-methylpropionaldehyde) at a degree of substitution of 1 mole of polymer/mole of protein.
Maltese: Da methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde (20 kDa mPEG-O-2-methylpropionaldehyde) fi grad ta' sostituzzjoni ta' 1 mole ta' polymer/mole ta' proteina.
English: Peginterferon beta-1a was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test and was not clastogenic in an in vitro assay in human lymphocytes.
Maltese: Peginterferon beta-1a ma kienx mutaġeniku meta ġie ttestjat f'test tal-mutazzjoni reverse batterjali in vitro (Ames), u ma kienx klastoġeniku f'assaġġ in vitro f'limfoċiti umani.
English: The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Maltese: Il-maġġoranza taż-żidiet fl-enzimi kienet ta' <3 darbiet tal-limitu ta' fuq tan-normal (ULN).
English: • Gauze pad
Maltese: • Stikk adeżiv
English: 125 (full dose)
Maltese: 125 (doża sħiħa)
English: Of a total of 1468 patients, 658 patients continued at least 4 years of treatment with Plegridy.
Maltese: Minn total ta' 1468 pazjent, 658 pazjent komplew mill-inqas 4 snin ta' kura bi Plegridy.
English: Step 3: Check your Plegridy pen (see Figure C)
Maltese: Pass 3: Iċċekkja l-pinna ta' Plegridy tiegħek (ara Figura C)
English: Severe renal impairment
Maltese: Rata ta' rikaduti annwalizzata
English: - Store in a refrigerator (fridge) 2º-8ºC.
Maltese: - Aħżen fi friġġ, f'temperatura bejn 2º-8ºC.
English: - Contact a doctor as they may be signs of a possible kidney problem.
Maltese: Ikkuntattja tabib għax dawn jistgħu jkunu sinjali ta' problema possibbli tal-kliewi.
English: This medicine contains less than 1 mmol sodium (23 mg), that is to say it is essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg), jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Aspartate aminotransferase increased
Maltese: Żidiet ta' alanine aminotransferase u aspartate aminotransferase (>5 darbiet tal
English: The observed Cmax (mean±SE) was 280 ± 79 pg/mL following repeat dosing of 125 micrograms every two weeks.
Maltese: 280 ± 79 pg/mL wara dożaġġ ripetut ta' 125 mikrogramma kull ġimagħtejn.
English: - Seizures
Maltese: - Urtikarja
English: Hyperthermia
Maltese: Ipertermija
English: - Injection site damage
Maltese: • Tkun skaduta.
English: The serum half-life of peginterferon beta-1a is prolonged compared with non-pegylated interferon beta-1a.
Maltese: Il-half-life fis-serum ta' peginterferon beta-1a hi twila meta mqabbla ma' non-pegylated interferon beta-1a.
English: Alanine aminotransferase increased
Maltese: Żieda f'alanine aminotransferase Komuni Żieda f'aspartate aminotransferase
English: The active substance in Plegridy is peginterferon beta-1a.
Maltese: Is-sustanza attiva fi Plegridy hi peginterferon beta-1a.
English: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections.
Maltese: Sodium acetate trihydrate, acetic acid, glacial, arginine hydrochloride, polysorbate 20, ilma għal injezzjonijiet.
English: Step 6: Give the injection a. Hold the pen over your injection site.
Maltese: Pass 6: Agħti l-injezzjoni a.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Maltese: L-interferons ġew irrappurtati li jnaqqsu l attività ta' enzimi epatiċi dipendenti fuq ċitokrom P450 fil-bnedmin u fl-annimali.
English: Initiation Pack.
Maltese: Mhux applikabbli.
English: Pre-Filled Syringe 125 mcg
Maltese: Pinna Mimlija għal-Lest 125 mcg
English: Each haemodialysis reduced peginterferon beta-1a concentration by approximately 24%, suggesting that haemodialysis partially removes peginterferon beta-1a from systemic circulation.
Maltese: Kull emodijalisi naqqset il konċentrazzjoni ta' peginterferon beta-1a b'madwar 24%, u dan jissuġġerixxi li l-emodijalisi tneħħi parzjalment peginterferon beta-1a miċ-ċirkolazzjoni sistemika.
English: Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens).
Maltese: Pakketti multipli li fihom 6 (3 pakketti ta' 2) pinen mimlija għal-lest ta' 125 mikrogramma (pinen bit tikketta griża).
English: Pharmacokinetics observed in multiple sclerosis patients were consistent with those seen in healthy subjects.
Maltese: Il-farmakokinetika osservata f'pazjenti bi sklerożi multipla kienet konsistenti ma' dik osservata f'individwi b'saħħithom.
English: Peginterferon beta-1a is a modified long-acting form of interferon.
Maltese: Peginterferon beta-1a hi forma modifikata ta' interferon li taġixxi fit-tul.
English: Peginterferon beta-1a has not been tested for reproductive toxicity in pregnant animals.
Maltese: Peginterferon beta-1a ma ġiex ttestjat għal tossiċità riproduttiva f'annimali tqal.
English: The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Maltese: L-ADRs huma ppreżentati bħala termini ppreferuti MedDRA taħt is-Sistema tal-Klassifika tal-Organi
English: P-value p=0.0007
Maltese: valur p p=0.0007
English: Plegridy should be administered with caution to patients with previous depressive disorders (see section 4.3).
Maltese: Plegridy għandu jingħata b'kawtela lil pazjenti b'disturbi depressivi fil-passat (ara sezzjoni 4.3).
English: The dose indicates the quantity of the interferon beta-1a moiety of peginterferon beta-1a without consideration of the PEG moiety attached.
Maltese: Id-doża tindika l-kwantità tal-interferon beta-1a moiety ta' peginterferon beta-1a mingħajr konsiderazzjoni tal-PEG moiety imwaħħla.
English: Warning!
Maltese: ADVANCE.
English: This tells you that the injection is happening (see Figure G).
Maltese: Dan jgħidlek li tkun qed isseħħ l-injezzjoni (ara Figura G).
English: Before use - Parts of Plegridy Pen (Figure A)
Maltese: Qabel l-użu - Partijiet tal-Pinna ta' Plegridy (Figura A)
English: Elevated serum hepatic transaminase levels, hepatitis, autoimmune hepatitis and rare cases of severe hepatic failure have been reported with interferon beta medicinal products.
Maltese: Livelli għoljin ta' serum transaminase tal-fwied, epatite, epatite awtoimmuni u każijiet rari ta' insuffiċjenza severa tal-fwied ġew irrappurtati bi prodotti mediċinali li jkun fihom interferon beta.
English: Syringe label
Maltese: Tikketta tas-Siringa
English: Let the pen warm to room temperature for at least 30 minutes.
Maltese: Ħalli l-pinna tisħon sakemm tilħaq it-temperatura tal-kamra għal mill-inqas 30 minuta.
English: MRI endpoints
Maltese: Punti aħħarin tal-MRI