FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 366 (96%) patients in the erenumab arms and 265 (93%) patients in the placebo arm completed the study (i.e. completed Week 12 assessment).
Maltese: Total ta' 366 (96%) pazjent fil-fergħat ta' erenumab u 265 (93%) pazjent fil-fergħa ta' plaċebo lestew l-istudju (jiġifieri lestew il-valutazzjoni wara 12-il Ġimgħa).
English: While pinching, insert the syringe needle into the skin at an angle of 45 to 90 degrees.
Maltese: Filwaqt li toqros il-ġilda, daħħal il-labra tas-siringa fil-ġilda f'angolu ta' bejn 45 u 90 grad.
English: Aimovig is available in packs containing 1 pre-filled pen and in multipacks containing 3 (3x1) pre-filled pens.
Maltese: Aimovig huwa disponibbi f'pakketti li fihom pinna waħda mimlija għal-lest u f'pakketti multipli li fihom 3 (3x1) pinen mimlija għal-lest.
English: There may be local regulations for disposal.
Maltese: Jista' jkun hemm regolamenti lokali għarrimi.
English: Erenumab is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor.
Maltese: Erenumab huwa korp monoklonali uman li jeħel mar-riċettur tal-peptide relatat mal-ġene ta' calcitonin (CGRP).
English: Aimovig contains the active substance erenumab.
Maltese: Aimovig fih is-sustanza attiva erenumab.
English: Pre-filled syringe
Maltese: Spażmi fil-muskoli
English: Renal impairment / hepatic impairment
Maltese: Indeboliment tal-kliewi / indeboliment tal-fwied
English: Monthly acute migrainespecific medication days Mean change (95% CI)
Maltese: Jiem ta' mediċini speċifiċi akuti għal emigranja fix-xahar Bidla fil-medja (95% CI)
English: In repeated-dose toxicology studies there were no adverse effects in sexually mature monkeys dosed up to 150 mg/kg subcutaneously twice weekly for up to 6 months at systemic exposures up to 123-fold and 246-fold higher than the clinical dose of 140 mg and 70 mg, respectively, every 4 weeks, based on serum AUC.
Maltese: Fi studji tat-tossikoloġija b'doża ripetuta ma kien hemm l-ebda effett avvers f'xadini sesswalment maturi li ngħataw dożi sa 150 mg/kg taħt il-ġilda darbtejn fil-ġimgħa għal perjodu sa 6 ġimgħat f'esponimenti sistemiċi sa 123 darba u 246 darba ogħla mid-doża klinika ta' 140 mg u 70 mg, rispettivament, kull 4 ġimgħat, abbażi tal-AUC fis-serum.
English: Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of dose-limiting toxicity.
Maltese: Fl-istudji kliniċi ngħataw dożi sa 280 mg taħt il-ġilda bl-ebda evidenza ta' tossiċità li tillimita d-doża.
English: Approximately 41% of patients in the study had medication overuse.
Maltese: Madwar 41% tal-pazjenti fl-istudju kellhom użu eċċessiv ta' mediċini.
English: The reduction in monthly migraine days from baseline to Week 52 was -4.22 in the 70 mg ATP group and -4.64 days in the 140 mg ATP group.
Maltese: It-tnaqqis fix-xahar tal-jiem bl-emigranja mil-linja bażi sat-52 Ġimgħa kien ta' -4.22 fil-grupp mogħti 70 mg waqt l-ATP u ta' -4.64 jiem fil-grupp mogħti 140 mg waqt l-ATP.
English: In patients failing two or more prophylactic pharmacotherapies the proportion was 41.3% for 140 mg and 35.6% for 70 mg versus 14.2% for placebo with an odds ratio of 4.2 (95% CI: 2.2, 7.9) and 3.5 (95% CI: 1.8, 6.6), respectively.
Maltese: F'pazjenti li ma rrispondewx għal żewġ farmakoterapiji profilattiċi jew aktar il-proporzjon kien ta' 41.3% għal 140 mg u 35.6% għal 70 mg kontra 14.2% għall-plaċebo bi proporzjonijiet ta' probabbiltà ta' 4.2 (95% CI: 2.2, 7.9) u 3.5 (95% CI: 1.8, 6.6), rispettivament.
English: Population pharmacokinetic analysis of integrated data from the Aimovig clinical studies did not reveal a difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment relative to those with normal renal function (see section 4.2).
Maltese: L-analiżi farmakokinetika tal-popolazzjoni tad-dejta integrata mill-istudji kliniċi ta' Aimovig ma żvelat l-ebda differenza fil-farmakokinetika ta' erenumab f'pazjenti b'indeboliment tal-kliewi ħafif jew moderat relattiv għal dawk b'funzjoni tal-kliewi normali (ara sezzjoni 4.2).
English: It belongs to a group of medicines called monoclonal antibodies.
Maltese: Jagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen
Maltese: Aimovig 70 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aimovig 140 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aimovig 70 mg soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Aimovig 140 mg soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest
English: In the clinical studies, the incidence of anti-erenumab antibody development during the double-blind treatment phase was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving a 140 mg dose of erenumab (none of whom had in vitro neutralising activity).
Maltese: Fl-istudji kliniċi, l-inċidenza ta' żvilupp ta' antikorpi antierenumab matul il-fażi tal-kura double-blind kienet ta' 6.3% (56/884) fost l-individwi li rċevew doża ta' 70 mg ta' erenumab (li 3 minnhom kellhom attività newtralizzati in vitro) u ta' 2.6% (13/504) fost individwi li rċevew doża ta' 140 mg ta' erenumab (li l-ebda wieħed minnhom ma kellu attività newtralizzati in vitro).
English: Aimovig (erenumab) was evaluated as monotherapy for prophylaxis of chronic migraine in a randomised, multicentre, 12-week, placebo-controlled, double-blind study in patients suffering from migraine with or without aura (≥15 headache days per month with ≥8 migraine days per month).
Maltese: Aimovig (erenumab) ġie evalwat bħala monoterapija għall-profilassi ta' emigranja kronika fi studju randomizzat, multiċentriku, ta' 12-il ġimgħa, ikkontrollat bi plaċebo, double-blind f'pazjenti li jbatu minn emigranja b'awra jew mingħajrha (≥15-il jum b'uġigħ ta' ras fix-xahar bi ≥8 jiem b'emigranja fix-xahar).
English: However, at therapeutically relevant doses, the pharmacokinetics of erenumab following subcutaneous dosing every 4 weeks are predominantly linear due to saturation of binding to CGRP-R. Subcutaneous administration of a 140 mg once monthly dose and a 70 mg once monthly dose in healthy volunteers resulted in a Cmax mean (standard deviation [SD]) of 15.8 (4.8) µg/ml and 6.1 (2.1) µg/ml, respectively, and AUClast mean (SD) of 505 (139) day*µg/ml and 159 (58) day*µg/ml, respectively.
Maltese: Erenumab juri kinetika mhux lineari bħala riżultat tal-irbit tiegħu mar-riċettur CGRPR. Madankollu, f'dożi terapewtikament rilevanti, il-farmakokinetika ta' erenumab wara dożaġġ taħt il-ġilda kull 4 ġimgħat huma fil-biċċa l-kbira lineari minħabba s-saturazzjoni tal-irbit ma' CGRP-R. L-għoti taħt ilġilda ta' doża ta' 140 mg darba fix-xahar u ta' doża ta' 70 mg darba fix-xahar f'voluntiera f'saħħithom irriżultat f'medja ta' Cmax (devjazzjoni standard [SD]) ta' 15.8 (4.8) µg/ml u 6.1 (2.1) µg/ml, rispettivament, u medja ta' AUClast (SD) ta' 505 (139) jum*µg/ml u 159 (58) jum*µg/ml, rispettivament.
English: Overall, 68% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability, and 49% had failed two or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Maltese: B'mod ġenerali, 68% ma rrispondewx għal farmakoterapija profilattika preċedenti waħda jew aktar minħabba nuqqas ta' effikaċja jew tollerabbiltà ħażina, u 49% ma rrispondewx għal żewġ farmakoterapiji profilattiċi preċedenti jew aktar minħabba nuqqas ta' effikaċja jew tollerabbiltà ħażina.
English: The reported adverse drug reactions for 70 mg and 140 mg were injection site reactions (5.6%/4.5%), constipation (1.3%/3.2%), muscle spasms (0.1%/2.0%) and pruritus (0.7%/1.8%).
Maltese: Ir-reazzjonijiet avversi għall-mediċina rrappurtati għal 70 mg u 140 mg kienu reazzjonijiet fis-sit talinjezzjoni (5.6%/4.5%), stitikezza (1.3%/3.2%), spażmi fil-muskoli (0.
English: Needle cap contains latex.
Maltese: L-għatu tal-labra fih il-latex.
English: Finger flange
Maltese: Agħfas 'l isfel
English: Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).
Maltese: Aimovig jiġi f'siringa mimilija għal-lest (1 ml, ħġieġ tat-Tip 1) b'labra tal-azzar inossidabbli u għatu tal-labra (latex li fih il-lasktu).
English: There was also a higher proportion of subjects treated with erenumab who achieved at least 50% reduction of MMD compared to placebo in the patients failing one or more prophylactic pharmacotherapies (40.8% for 140 mg, 34.7% for 70 mg versus 17.3% for placebo), with an odds ratio of 3.3 (95% CI: 2.0, 5.5) for 140 mg and 2.6 (95% CI: 1.6, 4.5) for 70 mg.
Maltese: Kien hemm ukoll proporzjon ogħla ta' pazjenti ttrattati b'erenumab li kisbu mill-inqas 50% tnaqqis fl-MMD imqabbel mal-plaċebo fost il-pazjenti li ma rrispondewx għal farmakoterapija profilattika waħda jew aktar (40.8% għal 140 mg, 34.7% għal 70 mg kontra 17.3% għal plaċebo), bil-proporzjon ta' probabbiltà ta' 3.3 (95% CI: 2.0, 5.5) għal 140 mg u 2.6 (95% CI: 1.6, 4.5) għal 70 mg.
English: To avoid discomfort at the site of injection, leave the syringe(s) at room temperature for at least 30 minutes before injecting.
Maltese: Biex tevita skumdità fis-sit tal-injezzjoni, ħalli s-siringa(i) f'temperatura tal-kamra għal tal-inqas 30 minuta qabel l-injezzjoni.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for erenumab, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal erenumab, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Aimovig (erenumab) was evaluated for prophylaxis of migraine in two pivotal studies across the migraine spectrum in chronic and episodic migraine.
Maltese: Aimovig (erenumab) kien evalwat għall-profilassi tal-emigranja f'żewġ studji pivotali fost il-firxa ta' emigranja f'każijiet ta' emigranja kronika u episodika.
English: Aimovig contains sodium Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Maltese: Aimovig fih anqas minn 1 mmol ta' sodju (23 mg) f'kull doża, jiġifieri essenzjalment “ħieles missodju”.
English: Do not shake.
Maltese: Se tisma' klikkjatura.
English: The treatment difference observed between erenumab 140 mg and placebo and between erenumab 70 mg and placebo for the reduction of MMD in these patients was -3.1 days (95% CI: -4.8, -1.4) in both cases, and for the reduction of acute migraine-specific medication days was -2.8 (95% CI: -4.2, -1.4) for 140 mg and -3.3 (95% CI: -4.7, -1.9) for 70 mg.
Maltese: Id-differenza fil-kura osservata bejn erenumab 140 mg u plaċebo u bejn erenumab 70 mg u plaċebo għat-tnaqqis ta' MMD f'dawn ilpazjenti kienet ta' -3.1 jiem (95% CI: -4.8, -1.4) fiż-żewġ każijiet, u għat-tnaqqis tal-jiem ta' mediċini akuti speċifiċi għal emigranja kien ta' -2.8 (95% CI: -4.2, -1.4) għal 140 mg u -3.3 (95% CI: -4.7, -1.9) għal 70 mg.
English: With the cap off, place the pen on the skin at an angle of 90 degrees.
Maltese: Bl-għatu maqlugħ, poġġi l-pinna fuq il-ġilda f'angolu ta' 90 grad.
English: Step 4: Finish
Maltese: Pass 4: Spiċċa
English: Remove Aimovig pre-filled syringe(s) from the carton by holding it/them at the barrel.
Maltese: Żomm is-siringa(i) fil-kartuna ta' barra sabiex tilqa' mid-dawl.
English: 70 mg: -0.9(-1.2, -0.6) 140 mg: -1.4 (-1.7, -1.1)
Maltese: 9(-1.2, -0.6) 140 mg: -1.4 (-1.7, -1.1)
English: Erenumab, as a human monoclonal antibody, is not metabolised by cytochrome P450 enzymes and hepatic clearance is not a major clearance pathway for erenumab (see section 4.2).
Maltese: Erenumab, bħala antikorp monoklonali tal-bniedem, mhuwiex metabolizzat mill-enzimi P450 taċ-ċitokromu u t-tneħħija mill-fwied mhijiex mogħdija ta' tneħħija ewlenija għal erenumab (ara sezzjoni 4.2).
English: How to store Aimovig
Maltese: Kif taħżen Aimovig
English: Aimovig is supplied in a pre-filled pen (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).
Maltese: Aimovig jiġi f'pinna mimlija għal-lest (1 ml, ħġieġ tat-Tip 1) b'labra tal-azzar inossidabbli u għatu tal-labra (latex li fih il-lasktu).
English: It is normal to see a drop of liquid at the end of the needle or safety guard.
Maltese: Huwa normali li tara taqtira likwidu fit-tarf tal-labra jew il-protezzjoni tas-sigurtà.
English: Used plunger Finger flange
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-PINNA
English: There was a higher proportion of patients in the erenumab group who achieved at least a 50% reduction of MMD compared to placebo (34.6% for 140 mg, 36.4% for 70 mg versus 17.7% for placebo), with an odds ratio of 2.5 (95% CI: 1.3, 4.9) and 2.7 (95% CI: 1.4, 5.2), respectively.
Maltese: Kien hemm proporzjon ogħla ta' pazjenti fil-grupp ta' erenumab li kisbu tnaqqis ta' millinqas 50% ta' MMD meta mqabbel ma' plaċebo (34.6% għal 140 mg, 36.4% għal 70 mg meta mqabbel ma' 17.7% għal plaċebo), bi proporzjon ta' probabbiltà ta' 2.5 (95% CI: 1.3, 4.9) u 2.7 (95% CI: 1.4, 5.2), rispettivament.
English: There was also a higher proportion of subjects treated with erenumab who achieved at least 50% reduction of MMD compared to placebo (39.7% for 140 mg and 38.6% for 70 mg, with an odds ratio of 3.1 [95% CI: 1.7, 5.5] and 2.9 [95% CI: 1.6, 5.3], respectively).
Maltese: Kien hemm ukoll proporzjon ogħla ta' pazjenti ttrattati b'erenumab li kisbu mill-inqas 50% tnaqqis fl-MMD imqabbel mal-plaċebo (39.7% għal 140 mg, 38.6% għal 70 mg, bil-proporzjon ta' probabbiltà ta' 3.1 [95% CI: 1.7, 5.5] u 2.9 [95% CI: 1.6, 5.3], rispettivament).
English: Pre-filled pen
Maltese: Reazzjonijiet fil-ġilda
English: Overall, 39% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Maltese: Kollox ma' kollox, 39% ma rrispondewx għal farmakoterapija profilattika waħda jew aktar minħabba nuqqas ta' effikaċja jew tollerabbiltà batuta.
English: In a reproduction study in cynomolgus monkeys there were no effects on pregnancy, embryo-foetal or post-natal development (up to 6 months of age) when erenumab was dosed throughout pregnancy at exposure levels approximately 17-fold and 34-fold higher than those achieved in patients receiving erenumab 140 mg and 70 mg, respectively, every 4 weeks dosing regimen based on AUC.
Maltese: Fi studju dwar ir-riproduzzjoni f'xadini cynomolgus ma kien hemm l-ebda effett fuq it-tqala, liżvilupp embrijofetali jew wara t-twelid (sa 6 xhur ta' età) meta erenumab ingħata matul it-tqala kollha f'livelli ta' esponiment ta' madwar 17-il darba u 34 darba ogħla minn dawk miksuba f'pazjenti li jirċievu erenumab fir-reġim ta' dożaġġ ta' 140 mg u 70 mg, rispettivament, kull 4 ġimgħat abbażi talAUC.
English: SYRINGE LABEL
Maltese: Labra użata
English: MIDAS (modified) total Mean changec (95% CI)
Maltese: Total (modifikat) MIDAS
English: Erenumab is not pharmacologically active in rodents.
Maltese: Erenumab mhuwiex farmakoloġikament attiv fir-rodituri.
English: In patients failing one or more prophylactic pharmacotherapies the treatment difference for the reduction of MMD observed between erenumab 140 mg and placebo was -2.5 (95% CI: -3.4, -1.7) and between erenumab 70 mg and placebo -2.0 (95% CI: -2.8, -1.2).
Maltese: F'pazjenti li ma rrispondewx għal farmakoterapija profilattika waħda jew aktar id-differenza fil-kura fejn jidħol tnaqqis fl-MMD osservat bejn erenumab 140 mg u plaċebo kien ta' -2.5 (95% CI: -3.4, -1.7) u bejn erenumab 70 mg u plaċebo ta' -2.0 (95% CI: -2.8, -1.2).
English: Inhibition of the effects of CGRP could theoretically attenuate compensatory vasodilation in ischaemic-related conditions.
Maltese: L-inibizzjoni tal-effetti tas-CGRP tista' teoretikament tnaqqas il-vażodilazzjoni kompensatorja f'kundizzjonijiet b'rabta mal-iskemija.
English: OTHER
Maltese: It-tnejn
English: Cotton balls or gauze pads Adhesive plasters Sharps disposal container
Maltese: tal-garża - Stikka (stikek) - Kontenitur għar-rimi tal labar u s-siringi
English: Mean change c
Maltese: Bidla fil-medja c
English: Muscle spasms
Maltese: Reazzjoni avversa
English: In patients failing one or more prophylactic pharmacotherapies the treatment difference for the reduction of monthly migraine days (MMD) observed between erenumab 140 mg and placebo was -3.3 days (95% CI: -4.6, -2.1) and between erenumab 70 mg and placebo -2.5 days (95% CI: -3.8, -1.2).
Maltese: F'pazjenti li ma rrispondewx għal farmakoterapija profilattika waħda jew aktar id-differenza fil-kura fejn jidħol tnaqqis fil-jiem ta' emigranja fix-xahar (MMD) osservat bejn erenumab 140 mg u plaċebo kien ta' -3.3 ġranet (95% CI: -4.6, -2.1) u bejn erenumab 70 mg u plaċebo ta' -2.5 ġranet (95% CI: -3.8, -1.2).
English: The recommended dose is 70 mg erenumab every 4 weeks.
Maltese: Id-doża rakkomandata hija ta' 70 mg erenumab kull 4 ġimgħat.
English: In patients failing two or more prophylactic pharmacotherapies the treatment difference was -4.3 days (95% CI: -5.8; -2.8) between 140 mg and placebo and -2.7 days (95% CI: -4.2, -1.2) between 70 mg and placebo.
Maltese: F'pazjenti li ma rrispondewx għal żewġ farmakoterapiji profilattiċi jew aktar iddifferenza fil-kura kienet ta' -4.3 ġranet (95% CI: -5.8; -2.8) bejn 140 mg u plaċebo u -2.7 ġranet (95% CI: -4.2, -1.2) bejn 70 mg u plaċebo.
English: Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash.
Maltese: Ħakk jinkludi t-termini preferuti ta' ħakk ġeneralizzat, ħakk u raxx b'ħakk.
English: Inspect the syringe(s).
Maltese: Terġax tuża s-siringa.
English: Adhesive plaster(s) Sharps disposal container
Maltese: Protezzjoni tassigurtà s-safra
English: No effect on exposure of co-administered medicinal products is expected based on the metabolic pathways of monoclonal antibodies.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Mhux mistenni effett fuq l-espożizzjoni tal-għoti flimkien ta' prodotti mediċinali abbażi tal-mogħdijiet metaboliċi tal-antikorpi monoklonali.
English: One pre-filled syringe contains 140 mg erenumab.
Maltese: Pinna waħda mimlija għal-lest fiha 140 mg erenumab.
English: Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Maltese: Aimovig huwa indikat għall-profilassi tal-emigranja f'adulti li jkollhom tal-inqas 4 ijiem b'emigranja fix-xahar.
English: In the integrated 12-week placebo-controlled phase of the studies, non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
Maltese: Fil-fażi integrata ta' 12-il ġimgħa kkontrollata bi plaċebo tal-istudji, kienu osservati każijiet mhux serji ta' raxx, ħakk u nefħa/edema, li fil-biċċa l-kbira tal-każijiet kienu ħfief u ma wasslux sabiex jitwaqqaf it-trattament.
English: One pre-filled pen contains 70 mg erenumab.
Maltese: Pinna waħda mimlija għal-lest fiha 70 mg erenumab.
English: Do not leave the cap off for more than 5 minutes.
Maltese: Linjezzjoni għandha tingħata fi żmien 5 minuti.
English: Two elimination phases were observed for erenumab.
Maltese: Ġew osservati żewġ fażijiet ta' eliminazzjoni għal erenumab.
English: Grey needle cap off
Maltese: Ir-Renju Unit
English: - Aimovig 70 mg solution for injection in pre-filled pen contains 70 mg erenumab.
Maltese: - Aimovig 70 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest fiha 70 mg erenumab.
English: Measurable erenumab serum concentrations were observed in the infant monkeys at birth, confirming that erenumab, like other IgG antibodies, crosses the placental barrier.
Maltese: Il-karatteristiċi tad-demografija u l-marda fil-linja bażi kienu bbilanċjati u komparabbli bejn iż-żewġ fergħat.
English: Erenumab potently and specifically competes with the binding of CGRP and inhibits its function at the CGRP receptor, and has no significant activity against other calcitonin family of receptors.
Maltese: Erenumab jikkompeti b'mod qawwi u speċifiku mat-twaħħil tas-CGRP u jinibixxi l-funzjoni tiegħu fir-riċettur tas-CGRP, u m'għandux attività sinjifikanti kontra riċetturi oħrajn talfamilja ta' calcitonin.
English: Figure 1 Change from baseline in monthly migraine days over time in Study 1 (including primary endpoint at Month 3)
Maltese: Figura 1 Bidla mil-linja bażi fil-jiem b'emigranja fix-xahar maż-żmien fl-Istudju 1 (inkluż ilpunt aħħari primarju fit-Tielet Xahar)
English: Based on this the PRAC considers that hypersensitivity reactions including rash, swelling/oedema and urticaria should be added as new adverse drug reactions in section 4.8 of the SmPC, and in the package leaflet.
Maltese: Abbażi ta' dan il-PRAC jikkunsidra li reazzjonijiet ta' sensittività eċċessiva li jinkludu raxx, nefħa/edima u urtikarja għandhom jiġu miżjuda bħala reazzjonijiet avversi tal-mediċina ġodda fis-sezzjoni 4.8 tal-SmPC, u fil-fuljett ta' tagħrif.
English: Table 3 Change from baseline in efficacy and patient-reported outcomes at Weeks 13-24 in Study 2
Maltese: Tabella 3 Bidla mil-linja bażi fl-effikaċja u l-eżiti rrappurtati mill-pazjenti wara 13-24
English: Thigh
Maltese: Stitikezza
English: Patients treated with erenumab had a clinically relevant and statistically significant reduction from baseline in the frequency of migraine days from Months 4 to 6 (Figure 2) compared to patients receiving placebo.
Maltese: Il-pazjenti kkurati b'erenumab kellhom tnaqqis klinikament rilevanti u statistikament sinifikanti millinja bażi fil-frekwenza ta' jiem b'emigranja bejn ir-Raba' u s-Sitt Xahar (Figura 2) meta mqabbla malpazjenti li rċevew plaċebo.
English: Cotton ball(s) or gauze pad(s)
Maltese: - Pinna ġdida/Pinen ġodda - Biċċa(iet) bl-alkoħol - Tajjara (tajjar) jew pad(s)
English: Efficacy outcomes MMD
Maltese: Eżiti tal-effikaċja MMD
English: One pre-filled syringe contains 70 mg erenumab.
Maltese: Siringa waħda mimlija għal-lest fiha 70 mg erenumab.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq is-sistema riproduttiva (ara sezzjoni 5.3).Bћala prekawzjoni hu preferribli li ma jintuzax Aimovig waqt it-tqala.
English: Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi kollha għall-mediċina li seħħew f'pazjenti kkurati b'Aimovig matul il-perjodi kkontrollati bi plaċebo ta' 12-il ġimgħa tal-istudji, kif ukoll fl-ambjent ta' wara ttqegħid fis-suq.
English: - Aimovig 140 mg solution for injection in pre-filled syringe contains 140 mg erenumab.
Maltese: - Aimovig 140 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest fiha 140 mg erenumab.
English: - Aimovig 140 mg solution for injection in pre-filled pen contains 140 mg erenumab.
Maltese: - Aimovig 140 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest fiha 140 mg erenumab.
English: Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1).
Maltese: Xi pazjenti jistgħu jibbenefikaw minn doża ta' 140 mg kull 4 ġimgħat (ara sezzjoni 5.1).
English: Throughout the dosing period erenumab is predominantly eliminated via a non-specific proteolytic pathway with the effective half-life of 28 days.
Maltese: Matul il-perjodu ta' dożaġġ kollu, erenumab huwa fil-biċċa l-kbira eliminat permezz ta' mogħdija proteolitika mhux speċifika b'nofs ħajja effettiva ta' 28 jum.
English: Both a
Maltese: Ħakk a
English: There were 117 cases with 130 adverse events of hypersensitivity in the MAH's global safety database.
Maltese: Kien hemm 117-il każ b'130 avveniment avvers ta' sensittività eċċessiva fid-database globali tassigurtà tal-MAH. 114-il każ kienu riċevuti minn sorsi ta' wara t-tqegħid fis-suq u 3 minn provi kliniċi.
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lot