FrancophonIA/ELRC3.0 huggingface dataset:
English: - For patients with ≥2 relapses in the previous year and at least 1 Gd+ lesion (n=273), the annual relapse rate at 1 year was 0.47 for placebo, 0.35 for Plegridy every 4 weeks, and 0.33 for Plegridy every 2 weeks.
Maltese: - Għal pazjenti b'≥2 rikaduti fl-aħħar sena u b'mill-inqas leżjoni Gd+ 1 (n=273), ir-rata annwalizzata ta' rikaduti f'sena 1 kienet 0.47 għal plaċebo, 0.35 għal Plegridy kull 4 ġimgħat, u 0.33 għal Plegridy kull ġimagħtejn.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON Pre-filled pen 125 mcg Multipack (with bluebox)
Maltese: KARTUNA TA' BARRA TAL-PAKKETT MULTIPLU Pinna mimlija għal-lest 125 mcg Pakkett multiplu (bil-kaxxa l-blu)
English: 1 pre-filled syringe of 63 micrograms 1 pre-filled syringe of 94 micrograms
Maltese: 1 siringa mimlija għal-lest ta' 63 mikrogramma 1 siringa mimlija għal-lest ta' 94 mikrogramma
English: Nephrotic syndrome (class effects)
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Sindrome nefrotiku (effetti tal-klassi)
English: Table on the inner lid Injection Record Day 0 (63 micrograms) Day 14 (94 micrograms) Date
Maltese: Tabella fuq l-għatu ta' ġewwa Djarju tal-Injezzjonijiet Jum 0 (63 mikrogramma)
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, immunostimulants, interferons, ATC code: L03AB13
Maltese: Mediċini antineoplastiċi u immunomodulanti, immunostimulanti,
English: Race had no effect on the pharmacokinetics of peginterferon beta-1a in a population pharmacokinetic analysis.
Maltese: Ir-razza ma kellha l-ebda effett fuq il-farmakokinetika ta' peginterferon beta-1a f'analiżi farmakokinetika tal-popolazzjoni.
English: First injection: 63 micrograms, choose orange pen
Maltese: L-ewwel injezzjoni: 63 mikrogramma, agħżel is-siringa oranġjo
English: P-value p=0.0003
Maltese: valur p p=0.0003
English: Plegridy also significantly reduced the risk of relapse by 39% (p=0.0003), the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks (post-hoc analysis) by 54% (p=0.0069), the number of new or newly enlarging T2 lesions by 67% (p<0.0001), the number of Gd-enhancing lesions by 86% (p<0.0001) and the number of new T1 hypointense lesions compared to placebo by 53% (p<0.0001).
Maltese: Plegridy kull ġimagħtejn naqqas b'mod sinifikanti r-rata annwalizzata ta' rikaduti (ARR) b'36% meta mqabbla mal-plaċebo (p=0.0007) wara sena (Tabella 3) bi tnaqqis konsistenti tal-ARR osservata fissottogruppi definiti minn karatteristiċi demografiċi u fil-linja bażi tal-marda Plegridy naqqas ukoll irriskju ta' rikaduta b'mod sinifikanti b'39% (p=0.0003), ir-riskju ta' progressjoni għal diżabilità sostnuta kkonfermat wara 12-il ġimgħa bi 38% (p=0.0383) u wara 24 ġimgħa (analiżi post-hoc) b'54% (p=0.0069), in-numru ta' leżjonijiet ġodda jew leżjonijiet T2 li qed jikbru b'67% (p<0.0001), innumru ta' leżjonijiet li jtejbu l-Gd b'86% (p<0.0001) u numru ta' leżjonijiet ipointensi
English: Decreases in white blood cell counts of <3.0 x 109/L were observed in 7% of patients receiving Plegridy and in 1% receiving placebo.
Maltese: Tnaqqis fl-għadd taċ-ċelluli bojod tad-demm ta' <3.0 x 109/L ġie osservat f'7% tal-pazjenti li kienu qed jirċievu Plegridy u f'1% li kienu qed jirċievu plaċebo.
English: Mean/Median disease duration (years) Mean number of relapses within the past 3 years 2.5 Mean EDSS score at baseline EDSS: Expanded Disability Status Scale Gd+: Gadolinium-enhancing
Maltese: Expanded Disability Status Scale Gd+: li jtejbu Gadolinium
English: A single-dose study in healthy subjects and subjects with various degrees of renal impairment (mild, moderate, and severe renal impairment as well as subjects with end state renal disease) showed a fractional increase in AUC (13-62%) and Cmax (42-71%) in subjects with mild (estimated glomerular filtration rate 50 to ≤80 mL/min/1.73m2), moderate (estimated glomerular filtration rate 30 to <50 mL/min/1.73m2), and severe (estimated glomerular filtration rate <30 mL/min/1.73m2) renal impairment, compared to subjects with normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m2).
Maltese: Studju dwar dożi waħidhom f'individwi b'saħħithom u f'individwi b'diversi gradi ta' indeboliment tal-kliewi (ħafif, moderat, u indeboliment sever tal-kliewi, kif ukoll individwi b'mard tal-kliewi li jkun fl-aħħar stadju), wera żieda frazzjonali fl-AUC (13-62%) u fis-Cmax (42-71%) f'individwi b'indeboliment ħafif (rata stmata ta' filtrazzjoni glomerulari minn 50 sa ≤80 mL/min/1.73m2), moderat
English: CI: Confidence interval * Sustained disability progression was defined as at least a 1 point increase from baseline EDSS ≥ 1 or 1.5 point increase for patients with baseline EDSS of 0, sustained for 12 / 24 weeks.
Maltese: * Progressjoni għal diżabilità sostnuta kienet definita bħala mill-inqas żieda ta' punt 1 mil-linja bażi EDSS ≥ 1 jew żieda ta' 1.5 punti għal pazjenti b'EDSS fil-linja bażi ta' 0, sostnuta għal 12/24 ġimgħa.
English: Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Maltese: Testijiet regolari tal-funzjoni tat-tirojde huma rakkomandati f'pazjenti bi storja medika ta' disfunzjoni tattirojde jew kif indikat klinikament.
English: An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Maltese: Dan ikun fih l-ewwel 2 dożi (63 mikrogramma u 94 mikrogramma).
English: The safety and efficacy of Plegridy in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis.
Maltese: Is-sigurtà u l-effikaċja ta' Plegridy fi tfal u adolexxenti minn età ta' 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: The pharmacological properties of Plegridy are consistent with those of interferon beta-1a and are believed to be mediated by the protein portion of the molecule.
Maltese: Il-propjetajiet farmakoloġiċi ta' Plegridy huma konsistenti ma' dawk ta' interferon beta-1a u huma maħsuba li jiġu medjati millporzjon tal-proteina tal-molekula.
English: b. Check the expiry date.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Accordingly, the half-life (t1/2) of peginterferon beta-1a is approximately 2-fold longer than non-pegylated interferon beta-1a in healthy volunteers.
Maltese: Għaldaqstant, il-half-life (t1/2) ta' peginterferon beta-1a hi itwal b'madwar iddoppju ta' dik ta' non-pegylated interferon beta-1a f'voluntiera b'saħħithom.
English: Two serious cases were reported in patients treated with Plegridy: one patient (<1%) experienced severe thrombocytopenia (platelet count <10 x 109/L), another patient (<1%) experienced severe neutropenia (neutrophil count <0.5 x 109/L).
Maltese: Żewġ każijiet serji ġew irrappurtati f'pazjenti kkurati bi Plegridy: pazjent wieħed (<1%) kellu tromboċitopenija severa (għadd tal-plejtlits ta' <10 x 109/L), u pazjent ieħor (<1%) kellu newtropenija severa (għadd tan-newtrofili ta' <0.5 x 109/L).
English: ┼ Class label for interferon products, see below Pulmonary arterial hypertension $ Class label for interferon products
Maltese: ┼ Tikketta tal-klassi għall-prodotti interferon, ara taħt Ipertensjoni arterjali tal-pulmun.
English: Interferons are a family of naturally occurring proteins that are induced by cells in response to biological and chemical stimuli, and mediate numerous cellular responses that have been classified as antiviral, antiproliferative, and immunomodulatory in nature.
Maltese: Interferons huma familja ta' proteini li jinħolqu b'mod naturali li huma indotti miċ-ċelluli b'rispons għal stimuli bijoloġiċi u kimiċi, u jimmedjaw reazzjonijiet ċellulari numerużi li ġew ikklassifikati bħal antivirali, antiproliferattivi, u immunomodulatorji fin-natura tagħhom.
English: Plegridy has not been studied in patients with hepatic impairment (see section 4.4).
Maltese: Plegridy ma ġiex studjat f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.4).
English: What Plegridy is
Maltese: Plegridy jista'
English: Mean [Median] no. of Gd-enhancing lesions (range) % reduction vs placebo P-value p<0.0001
Maltese: Medja [Medjan] tan-numru ta' leżjonijiet li jtejbu Gd (medda) % ta' tnaqqis kontra l-plaċebo valur p p<0.0001
English: Hypothyroidism and hyperthyroidism have been observed with the use of interferon beta products.
Maltese: Ipotirojdiżmu u ipertirojdiżmu ġew osservati bl-użu ta' prodotti li fihom interferon beta.
English: Second injection: 94 micrograms, choose blue syringe
Maltese: 94 mikrogramma, agħżel is-siringa blu
English: Patients may develop antibodies to Plegridy.
Maltese: Il-pazjenti jistgħu jiżviluppaw antikorpi għal Plegridy.
English: The Plegridy Initiation Pack contains 1x 63 micrograms pre-filled syringe (orange labelled syringe, 1st dose) and 1x 94 micrograms pre-filled syringe (blue labelled syringe, 2nd dose) in sealed plastic trays.
Maltese: Daqsijiet tal-pakketti Il-Pakkett tal-Bidu ta' Plegridy fih 1x siringa mimlija għal-lest ta' 63 mikrogramma (siringa bit tikketta oranġjo, 1el doża) u 1x siringa mimlija għal-lest ta' 94 mikrogramma (siringa bit-tikketta blu, 2ni doża) fi trejs issiġillati tal-plastik.
English: Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity.
Maltese: Mill-pazjenti li kellhom reazzjonijiet fis-sit tal injezzjoni, 95% irrappurtawhom bħala ħfief jew moderati fis-severità.
English: Data from studies with other interferon beta compounds did not show teratogenic potential.
Maltese: Dejta minn studji b'komposti oħrajn ta' interferon beta ma wrietx potenzjal teratoġeniku.
English: Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen
Maltese: Plegridy 125 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal‑lest Plegridy 63 mikrogramma soluzzjoni għall-injezzjoni f'pinna mimlija għal‑lest Plegridy 94 mikrogramma soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Plegridy 125 mikrogramma soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest
English: How to Inject Plegridy
Maltese: X'inhu Plegridy
English: This medicinal product contains less than 1 mmol (23 mg) sodium, that is to say it is essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium, jiġifieri essenzjalment “ħieles missodium”.
English: Nephrotic syndrome, glomerulosclerosis
Maltese: Sindrome nefrotiku,
English: Cases of TMA, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Maltese: Mikroanġjopatija trombotika (TMA) (effetti tal-klassi) Każijiet ta' TMA, li tidher bħala purpura tromboċitopenika trombotika (TTP) jew sindrome uremiku emolitiku (HUS), li jinkludu każijiet fatali, ġew irrappurtati bi prodotti li fihom interferon beta.
English: Fertility and developmental studies in rhesus monkeys have been carried out with non-pegylated interferon beta-1a.
Maltese: Studji dwar il-fertilità u l-iżvilupp f'xadini rhesus twettqu b'non-pegylated interferon beta-1a.
English: Pharmacodynamic responses were evaluated by measuring the induction of interferon-responsive genes including those encoding 2′,5′-oligoadenylate synthetase (2′,5′-OAS), myxovirus resistance protein A (MxA), and several chemokines and cytokines, as well as neopterin (D-erythro-1, 2, 3,trihydroxypropylpterin), a product of the interferon-inducible enzyme, GTP-cyclohydrolase I. Gene induction in healthy human subjects was greater in terms of peak level and exposure (area under the effect curve) for Plegridy compared to non-pegylated interferon beta-1a (IM) when both were given at the same dose by activity (6 MIU).
Maltese: proteina tar-reżistenza myxovirus A (MxA), u diversi chemokines u cytokines, kif ukoll neopterin (D-erythro-1, 2, 3,-trihydroxypropylpterin), prodott tal-enzima induċibbli minn interferon, GTP-cyclohydrolase I.
English: One patient out of 1468 patients who received Plegridy in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.
Maltese: Pazjent wieħed minn 1468 pazjent li rċivew Plegridy fl-istudji kliniċi kellu nekrożi fis-sit tal-injezzjoni, li fieqet b'kura medika standard.
English: After the injection After Use - Parts of your Plegridy pen (see Figure K):
Maltese: Wara l-Użu - Partijiet tal-Pinna ta' Plegridy tiegħek (ara Figura K):
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: - Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għal interferon beta jew peginterferon naturali jew rikombinanti jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Injection site reactions (e.g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received Plegridy 125 micrograms every 2 weeks compared to 11% of patients receiving placebo.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (eż. eritema fis-sit tal-injezzjoni, uġigħ, ħakk, jew edema) ġew irrappurtati minn 66% tal-pazjenti li rċivew Plegridy 125 mikrogramma kull ġimagħtejn meta mqabbla ma' 11% tal-pazjenti li kienu qed jirċievu plaċebo.
English: Proportion with 24-week confirmed disability progression*
Maltese: Proporzjon bi progressjoni ta' diżabilità kkonfermata ta' 24 ġimgħa*
English: Second injection: 94 micrograms, choose blue pen
Maltese: 94 mikrogramma, agħżel pinna blu
English: Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Maltese: Pazjenti li juru depressjoni għandhom jiġu mmonitorjati mill-qrib matul it-terapija u jiġu kkurati kif suppost.
English: Patients should be monitored for signs of hepatic injury (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali ta' feriti fil-fwied (ara sezzjoni 4.8).
English: Step 8: Check to make sure you received your full dose of Plegridy (see Figure J)
Maltese: Pass 8: Iċċekkja biex tkun ċert li rċivejt id-doża sħiħa ta' Plegridy (ara Figura J)
English: The Plegridy Pen Initiation Pack contains 1x 63 micrograms pre-filled pen (orange labelled pen, 1st dose) and 1x 94 micrograms pre-filled pen (blue labelled pen, 2nd dose) in a protective plastic tray.
Maltese: Il-Pakkett tal-Bidu ta' Plegridy fih 1x pinna mimlija għal-lest ta' 63 mikrogramma (pinna bit-tikketta oranġjo, 1el doża) u 1x pinna mimlija għal-lest ta' 94 mikrogramma (pinna bit-tikketta blu, 2ni doża) fi trej protettiv tal-plastik.
English: Influenza-like illness was experienced by 47% of patients receiving Plegridy 125 micrograms every 2 weeks and 13% of patients receiving placebo.
Maltese: Mard qisu influwenza affettwa lil 47% tal-pazjenti li kienu qed jirċievu Plegridy 125 mikrogramma kull ġimagħtejn u 13% tal-pazjenti li kienu qed jirċievu plaċebo.
English: 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
Maltese: Is-siringa fil-pinna hija siringa mimlija għal-lest ta' 1 mL magħmula mill-ħġieġ (Tip I) b'tapp tal-lastku tal-bromobutyl u protezzjoni riġida tal-labra termoplastika u tal-polypropylene, li jkun fiha 0.5 mL ta' soluzzjoni.
English: Patients exposed to Plegridy every 2 weeks showed statistically significant reductions compared to patients exposed to Plegridy every 4 weeks over 2 years in a post-hoc analysis for endpoints including ARR (24%, p=0.0209), the risk of relapse (24%, p=0.0212), the risk of disability progression with 24 week confirmation (36%, p=0.0459), and MRI endpoints (new/enlarging T2 60%, Gd+ 71%, and new T1 hypointense lesions 53%; p<0.0001 for all).
Maltese: (24%, p=0.0212), ir-riskju ta' progressjoni ta' diżabilità b'konferma ta' 24 ġimgħa (36%, p=0.0459), u punti aħħarin tal-MRI (leżjonijiet T2 ġodda/li jkunu qed jikbru 60%, Gd+ 71%, u leżjonijiet T1
English: Urticaria
Maltese: Doża
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Biogen Belgium NV/SA
English: Full dose injection: 125 micrograms, choose grey syringe
Maltese: 125 mikrogramma, agħżel is-siringa ġriża
English: The duration of this response was sustained and prolonged for Plegridy, with elevations detected up to 15 days compared to 4 days for non-pegylated interferon beta-1a.
Maltese: Ittul ta' żmien ta' dan ir-rispons kien sostnut u fit-tul għal Plegridy, b'żidiet osservati għal sa 15-il jum meta mqabbla ma' 4 ijiem għal non-pegylated interferon beta-1a.
English: The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Plegridy 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
Maltese: L-iktar reazzjonijiet avversi komuni tal-mediċina (ADR) (f'inċidenzaa ogħla mill-plaċebo) għal Plegridy 125 mikrogramma taħt il-ġilda kull ġimagħtejn kienu eritema fis-sit tal-injezzjoni, mard qisu influwenza, deni, uġigħ ta' ras, majalġja, tertir ta' bard, uġigħ fis-sit tal-injezzjoni, astenja, ħakk fis-sit tal-injezzjoni, u artralġja.
English: Starting Plegridy
Maltese: Plegridy.
English: Serum concentration of peginterferon beta-1a was dose-proportional in the range of 63 to 188 micrograms as observed in a single dose and a multiple dose study in healthy subjects.
Maltese: Il-konċentrazzjoni ta' peginterferon beta-1a fis-serum kienet proporzjonali għad-doża filmedda ta' 63 sa 188 mikrogramma, kif osservat fi studju dwar dożi waħidhom u dożi multipli f'individwi b'saħħithom.
English: Hypersensitivity events were reported in 16% of patients treated with Plegridy 125 micrograms every 2 weeks and 14% of patients who received placebo.
Maltese: Avvenimenti ta' sensittività eċċessiva ġew irrappurtati f'16% tal-pazjenti kkurati bi Plegridy 125 mikrogramma kull ġimagħtejn u 14% tal-pazjenti li rċivew plaċebo.
English: - Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness,
Maltese: - Tħossok żbilanċjat jew stordut, problemi biex timxi, ebusija u spażmi tal-muskoli, għeja,
English: Three simple ways to help reduce the impact of flu-like symptoms:
Maltese: Tliet metodi sempliċi biex tgħin ħalli tnaqqas l-impatt ta' sintomi qishom influwenza:
English: Mean [Median] no. of new T1 hypointense lesions (range) % reduction vs placebo P-value p<0.0001
Maltese: T1 ġodda meta mqabbla mal-plaċebo bi 53% (p<0.0001).
English: The incidence of cardiovascular events was similar between Plegridy (125 micrograms every 2 weeks) and placebo treatment groups (7% in each group).
Maltese: L-inċidenza ta' avvenimenti ta' aċċessjoni kienet baxxa u komparabbli f'pazjenti li kienu qed jirċievu Plegridy (125 mikrogramma kull ġimagħtejn) u plaċebo (<1% f'kull grupp).
English: Increased concentrations of neopterin were observed in both healthy subjects and multiple sclerosis patients treated with Plegridy, with a sustained and prolonged elevation over 10 days compared to 5 days observed for non-pegylated interferon beta-1a.
Maltese: Żiediet fil-konċentrazzjonijiet ta' neopterin ġew osservati kemm f'individwi b'saħħithom kif ukoll f'pazjenti bi sklerożi multipla kkurati bi Plegridy, b'żieda sostnuta u fit-tul fuq perjodu ta' 10 ijiem meta mqabbla ma' 5 ijiem osservati għal non-pegylated interferon beta-1a.
English: Subjects with end stage renal disease requiring 2-3 times haemodialysis weekly showed similar AUC and Cmax as compared to subjects with normal renal function.
Maltese: Individwi b'mard tal-kliewi li jkunu fl-aħħar stadju li jeħtieġu l-emodijalisi 2-3 darbiet kull ġimgħa, urew AUC u Cmax simili meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with Plegridy respectively.
Maltese: ULN), ġew irrappurtati f'1% u <1% ta' pazjenti kkurati bi plaċebo u 2% u <1% tal-pazjenti kkurati bi Plegridy, rispettivament.
English: On average, flu-like symptoms begin approximately 10 hours after injection and last between 12 and 24 hours.
Maltese: Bħala medja, sintomi bħal tal-influwenza jibdew bejn wieħed u ieħor 10 sigħat wara l-injezzjoni u jdumu bejn 12 u 24 siegħa.
English: This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 or over.
Maltese: Din il-mediċina tintuża għall-kura ta' sklerożi multipla li tirkadi u tbatti (MS) f'adulti li jkollhom 18-il sena jew aktar.
English: General warnings
Maltese: Reazzjoni avversa
English: 1 pre-filled pen of 63 micrograms 1 pre-filled pen of 94 micrograms
Maltese: 1 pinna mimlija għal-lest ta' 63 mikrogramma 1 pinna mimlija għal-lest ta' 94 mikrogramma
English: For more information see section 5.1.
Maltese: Għal aktar informazzjoni, ara sezzjoni 5
English: Following repeated subcutaneous administration of peginterferon beta-1a in rhesus monkeys at doses up to 400-fold (based on exposure, AUC) the recommended therapeutic dose; no effects other than the known mild pharmacological responses by rhesus monkeys to interferon beta-1a were observed after the first and second weekly dose.
Maltese: Wara l-għoti ripetut taħt il-ġilda ta' peginterferon beta-1a f'xadini rhesus f'dożi sa 400 darba (ibbażat fuq esponiment, AUC) tad-doża terapewtika rakkomandata, l-ebda effetti, ħlief ir-reazzjonijiet farmakoloġiċi ħfief minn xadini rhesus għal interferon beta-1a, ma ġew osservati wara l-ewwel u ttieni doża ta' kull ġimgħa.
English: Peginterferon beta-1a has not been tested for carcinogenicity in animals.
Maltese: Peginterferon beta-1a ma ġiex ittestjat għal karċinoġeneċità fl-annimali.
English: No information is available on the potential effects of peginterferon beta-1a on male fertility.
Maltese: M'hemmx informazzjoni disponibbli fuq leffetti potenzjali ta' peginterferon beta-1a fuq il-fertilità tal-irġiel.
English: The other ingredients are: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections (see Section 2 “Plegridy contains sodium”).
Maltese: Sodium acetate trihydrate, acetic acid, glacial, arginine hydrochloride, polysorbate 20 u ilma għall-injezzjonijiet (ara Sezzjoni 2 “Plegridy fih is-sodium”).
English: Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including Plegridy.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva inklużi każijiet ta' anafilassi ġew irrappurtati bħala kumplikazzjoni rari tal-kura b'interferon beta, li tinkludi Plegridy.
English: You will be provided with an Initiation Pack containing your first 2 injections: one orange pen with Plegridy 63 micrograms (for day 0) and one blue pen with Plegridy 94 micrograms (for day 14).
Maltese: Inti se tingħata Pakkett tal-Bidu li jkun fih l-ewwel 2 injezzjonijiet tiegħek: pinna waħda oranġjo bi Plegridy 63 mikrogramma (għal jum 0) u pinna waħda blu bi Plegridy 94 mikrogramma (għal jum 14).
English: Table 2: Study design
Maltese: Tabella 2: Disinn tal-istudju
English: After that you will be provided with a maintenance pack containing grey syringes with Plegridy 125 micrograms (for day 28 and then every two weeks).
Maltese: Wara dak il-perjodu, inti se tingħata pakkett ta' manteniment li jkun fih siringi griżi bi Plegridy 125 mikrogramma (għal jum 28 u mbagħad kull ġimagħtejn).