FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Kyndrisa (drisapersen)
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Maltese: Barra minn hekk, il-profil tas-sigurtà tal-mediċina ma kienx meqjus sodisfaċenti, b'mod partikolari minħabba r-riskju ta' reazzjonijiet persistenti fis-sit talinjezzjoni (bħal nefħa, infjammazzjoni u ulċerazzjoni) li jista' jkollhom effett negattiv fuq il-kwalità talħajja, u r-riskju ta' tromboċitopenija (għadd baxx ta' pjastrini fid-demm) li tista' tpoġġi lill-pazjenti f'riskju ta' kumplikazzjonijiet serji ta' fsada.
English: This medicine works by ‘exon 51 skipping
Maltese: Din il-mediċina taħdem permezz ta' 'teknoloġija li taqbeż exon 51'.
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Maltese: Fil-31 ta' Mejju 2016, BioMarin International Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Kyndrisa, għall-kura tad-distrofija muskolari ta' Duchenne.
English: What was Kyndrisa expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Kyndrisa?
English: Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin.
Maltese: Id-distrofija muskolari ta' Duchenne hija kkawżata minn mutazzjonijiet fil-ġene tal-proteina distrofin, li twassal għall-produzzjoni ta' distrofin mhux funzjonali.
English: The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
Maltese: Listudji qabblu l-effetti ta' Kyndrisa mal-plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien il-bidla fiddistanza li l-pazjent seta' jimxi f'sitt minuti wara 24 jew 48 ġimgħa ta' kura.
English: This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
Maltese: jaqbeż xi partijiet tal-ġene distrofin u tippermetti l-produzzjoni tal-proteina distrofin imqassra iżda li taħdem parzjalment.
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Maltese: Id-distrofija muskolari ta' Duchenne hija marda ġenetika serja, li prinċiparjament taffettwa lis-subien u ġeneralment issir dijanjożi tagħha qabel l-età ta' 6 snin.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy.
Maltese: Fuq il-bażi tar-rieżami tad-data u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li Kyndrisa ma setax jiġi approvat għall-kura tad-distrofija muskolari ta' Duchenne.
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Maltese: Il-kumpanija stqarret li kellha l-intenzjoni li twaqqaf l-iżvilupp tal-mediċina, iżda tippjana li taħdem mat-tobba, mal-pazjenti u mal-awtoritajiet regolatorji lokali sabiex tippermetti pazjenti attwalment ikkurati sabiex jaċċessaw il-provvista li baqgħet ta' Kyndrisa.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li qed jagħtihielek.
English: HIT-6 total
Maltese: HIT-6 totali
English: MIDAS total
Maltese: Total ta' MIDAS
English: Baseline (SD)
Maltese: Linja bażi (SD)
English: 22014 Incheon Republic of Korea
Maltese: Incheon Repubblika tal-Korea
English: Date of first authorisation: 28 March 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Marzu 2019
English: - The active substance is fremanezumab.
Maltese: - Is-sustanza attiva hi fremanezumab.
English: Frequency categories are based on the following convention: 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); very rare (<1/10,000).
Maltese: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Table 1: Adverse reactions in clinical studies MedDRA System Organ Class Frequency
Maltese: Tabella 1: Reazzjonijiet avversi fl-istudji kliniċi Klassi tas-Sistemi u talOrgani tal-MedDRA
English: Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) have not been studied.
Maltese: Pazjenti b'indeboliment renali sever (eGFR <30 mL/min/1.73m2) ma ġewx studjati.
English: AJOVY 225 mg injection fremanezumab SC
Maltese: AJOVY 225 mg injezzjoni fremanezumab SC
English: TD (95% CI)b
Maltese: Bidla medjaa (CI ta' TD (CI ta' 95%)b
English: The following ADRs have been identified in the AJOVY clinical development programme (Table 1).
Maltese: L-ADRs li ġejjin ġew identifikati fil-programm tal-iżvilupp kliniku ta' AJOVY (Tabella 1).
English: Fremanezumab has an estimated half-life of 30 days.
Maltese: Fremanezumab għandu half-life stmata ta' 30 jum.
English: In placebo-controlled studies, 0.4 % of patients (6 out of 1,701) treated with fremanezumab developed anti-drug antibodies (ADA).
Maltese: Fi studji kkontrollati bil-plaċebo, 0.4% tal-pazjenti (6 minn 1,701) ittrattati bi fremanezumab żviluppaw antikorpi kontra l-mediċina (ADA, anti-drug antibodies).
English: AJOVY contains sodium
Maltese: AJOVY fih sodium
English: Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: Merckle GmbH Graf-Arco-Str. 3 89079 Ulm
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80, water for injections.
Maltese: L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: TEVA GmbH Graf-Arco-Str. 3 89079 Ulm
English: Fremanezumab is highly specific for CGRP and does not bind to closely related family members (e.g., amylin, calcitonin, intermedin and adrenomedullin).
Maltese: Fremanezumab huwa speċifiku ħafna għal CGRP u ma jeħilx ma' membri tal-familja relatati mill-qrib ma' xulxin (eż., amylin, calcitonin, intermedin u adrenomedullin).
English: Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.
Maltese: Soluzzjoni ċara sa opalexxenti, bla kulur sa kemmxejn safra, b'pH ta' 5.5 u osmolalità ta' 300-450 mOsm/kg.
English: For further instructions on administration, see section 6.6.
Maltese: Għal istruzzjonijiet addizzjonali dwar l-għoti, ara sezzjoni 6.6.
English: Dose proportionality, based on population pharmacokinetics, was observed between 225 mg to 675 mg.
Maltese: Il-proporzjonalità tad-doża, abbażi talfarmakokinetika tal-popolazzjoni, kienet osservata bejn 225 mg sa 675 mg.
English: 75% Responder Rate MHD
Maltese: Rata ta' Rispons ta' 75% MHD
English: Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]).
Maltese: Reazzjonijiet avversi tal-mediċina rrappurtati b'mod komuni (ADRs, adverse drug reactions) kienu reazzjonijiet lokali fis-sit tal-injezzjoni (uġigħ [24%], ebusija [17%], eritema [16%] u ħakk [2%]).
English: AJOVY Syringe
Maltese: Tużax AJOVY
English: - The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.
Maltese: - Is-sustanzi (eċċipjenti) l-oħra huma L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 u ilma għall-injezzjonijiet.
English: There is limited data available on the use of fremanezumab in patients ≥65 years of age (2% of the patients).
Maltese: Hemm data limitata disponibbli dwar l-użu ta' fremanezumab f'pazjenti b'età ta' ≥65 sena (2% talpazjenti).
English: 50% Responder Rate MHD
Maltese: Rata ta' Rispons ta' 50% MHD
English: Step 2: How to inject a) Remove the protective cap and do not replace.
Maltese: Pass 2: Kif tinjetta a) Neħħi l-għatu protettiv u tbiddlux.
English: Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity.
Maltese: Dożi sa 2,000 mg ingħataw fil-vini fi provi kliniċi mingħajr tossiċità li tillimita d-doża.
English: How to store AJOVY 6.
Maltese: Kif taħżen AJOVY 6.
English: Similar to other monoclonal antibodies, fremanezumab is expected to be degraded by enzymatic proteolysis into small peptides and amino acids.
Maltese: B'mod simili għal antikorpi monoklonali oħrajn, hu mistenni li fremanezumab jiġi ddegradat permezz ta' proteolisi enzimatika f'peptides żgħar u aċidi amminiċi (amino acids).
English: With 12 months of treatment, ADA were detected in 2.3% of the patients (43 out of 1,888) with 0.95% of the patients developing neutralising antibodies.
Maltese: trattament, ADA kienu osservati fi 2.3% tal-pazjenti (43 minn 1,888) b'0.95% tal-pazjenti li żviluppaw antikorpi newtralizzanti.
English: P-value (vs. placebo)a p<0.0001
Maltese: Valur p (kontra plaċebo)a p<0.0001
English: Episodic migraine study (Study 1)
Maltese: Studju dwar l-emigranja episodika (Studju 1)
English: CI = confidence interval; MAHMD = monthly acute headache medication days; MHD = monthly headache days of at least moderate severity; MIDAS = Migraine Disability Assessment; MMD = monthly migraine days; SD = standard deviation; TD = treatment difference a For all endpoints mean change and CIs are based on the ANCOVA model that included treatment, gender,
Maltese: CI = intervall ta' kunfidenza (confidence interval); MAHMD = jiem ta' medikazzjoni għall-uġigħ ta' ras akut kull xahar (monthly acute headache medication days); MHD = jiem ta' wġigħ ta' ras kull xahar ta' severità mill inqas moderata (monthly headache days of at least moderate severity); MIDAS = Evalwazzjoni tal-Diżabilità minħabba l-Emigranja (Migraine Disability Assessment); MMD = jiem bl-emigranja kull xahar (monthly migraine days); SD = devjazzjoni standard (standard deviation);
English: The absolute bioavailability of fremanezumab after subcutaneous administration of 225 mg and 900 mg in healthy subjects was 55% (±SD of 23%) to 66% (±SD of 26%).
Maltese: Il-bijodisponibilità assoluta ta' fremanezumab wara għotja taħt il-ġilda ta' 225 mg u 900 mg f'individwi f'saħħithom kienet ta' 55% (±SD ta' 23%) sa 66% (±SD ta' 26%).
English: Mean at baseline (monthly average number of migraine days): Placebo: 9.1, AJOVY Quarterly: 9.2, AJOVY Monthly: 8.9.
Maltese: Plaċebo: 9.1, AJOVY Kull Tliet Xhur: 9.2,
English: Fremanezumab 675 mg quarterly
Maltese: Fremanezumab 675 mg kull tliet xhur
English: Population pharmacokinetic analysis of integrated data from the AJOVY clinical studies did not reveal a difference in the pharmacokinetics of fremanezumab in patients with mild to moderate renal impairment or hepatic impairment relative to those with normal renal or hepatic function (see section 4.2).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ta' data integrata minn studji kliniċi fuq AJOVY ma żvelatx differenza fil-farmakokinetika ta' fremanezumab f'pazjenti b'indeboliment renali ħafif sa moderat, jew indeboliment epatiku b'mod relattiv għal dawk li għandhom funzjoni renali jew epatika normali (ara sezzjoni 4.2).
English: The efficacy and safety of fremanezumab was demonstrated regardless of age, gender, race, use of concomitant preventive medicinal products (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants), use of topiramate or onabotulinumtoxin A for migraine in the past, and acute headache medication overuse.
Maltese: L-effikaċja u s-sigurtà ta' fremanezumab kienet murija irrispettivament mill-età, sess tal-persuna, razza, użu ta' prodott mediċinali ta' prevenzjoni konkomitanti (imblokkaturi tar-riċetturi beta, imblokkatur tal-kanali tal-calcium/benzocycloheptene, antidepressanti, prodotti antikonvulżivi), użu ta' topiramate jew onabotulinumtoxin A għall-emigranja fil-passat, u użu żejjed ta' medikazzjoni għall-uġigħ ta' ras akut.
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 urewx effetti tossiċi diretti jew indiretti fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: ADRs from clinical studies are presented according to MedDRA system organ classification.
Maltese: ADRs minn studji kliniċi huma ppreżentati skont il-klassifikazzjoni tas-sistemi u tal-organi MedDRA.
English: Chronic migraine study (Study 2)
Maltese: Studju dwar l-emigranja kronika (Studju 2)
English: Visit:
Maltese: Eċċipjenti:
English: Fremanezumab is a humanised IgG2Δa/kappa monoclonal antibody derived from a murine precursor.
Maltese: IgG2Δa/kappa umanizzat derivat minn prekursur talġrieden.
English: A total of 791 patients completed the 12-week double-blind treatment period.
Maltese: Total ta' 791 pazjent lestew ilperjodu ta' trattament double-blind ta' 12-il ġimgħa.
English: Since monoclonal antibodies are not known to be eliminated via renal pathways or metabolised in the liver, renal and hepatic impairment are not expected to impact the pharmacokinetics of fremanezumab.
Maltese: Peress li antikorpi monoklonali mhumiex magħrufa li jiġu eliminati mill-passaġġi renali jew metabolizzati fil-fwied, indeboliment renali u epatiku mhux mistenni li jaffettwa l-farmakokinetika ta' fremanezumab.
English: Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials.
Maltese: Kienu rrappurtati reazzjonijiet ta' sensittività eċċessiva bi fremanezumab f'inqas minn 1% tal-pazjenti fil-provi kliniċi.
English: Insert the needle into the pinched skin at a 45° to 90° angle.
Maltese: Daħħal il-labra ġol-ġilda l-maqrusa f'angolu ta' 45° sa 90°.
English: The patients enrolled had at least a 12-month history of migraine (with and without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Maltese: Il-pazjenti rreġistrati kellhom storja medika ta' emigranja ta' mill-inqas 12-il xahar (bi u mingħajr awra) skont il-kriterji ta' dijanjosi tal-Klassifikazzjoni Internazzjonali ta' Disturbi ta' Uġigħ ta' Ras (ICHD-III, International Classification of Headache Disorders).
English: Mean change a
Maltese: il ġimgħa.
English: A population pharmacokinetic analysis looking at age, race, gender, and weight was conducted on data from 2,546 subjects.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni li kkunsidrat l-età, ir-razza, is-sess tal-persuna, u l-piż talġisem ġiet imwettqa fuq data minn 2,546 individwu.
English: Percentage [%] P-value (vs. placebo)
Maltese: Valur p (kontra plaċebo)
English: Baseline Week 1 Week 2 Week 3 Month 1
Maltese: Żjara: Linja Bażi Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 Xahar 1
English: Teva Nederland B.V. Tel: +31 800 022 8400
Maltese: Tel: +31 800 022 8400
English: Fremanezumab 225 mg monthly
Maltese: Fremanezumab 225 mg kull xahar
English: Table 2: Key Efficacy Outcomes in Study 1 in Episodic Migraine Efficacy Endpoint
Maltese: Tabella 2: Riżultati Ewlenin tal-Effikaċja fi Studju 1 dwar l-Emigranja Episodika Punt Finali tal
English: − Check the syringe label.
Maltese: − Iċċekkja t-tikketta tas-siringa.
English: A sub-set of patients (21%) was also allowed to use one commonly used concomitant, preventive medicinal product (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants).
Maltese: imblokkatur tal-kanali tal-calcium/benzocycloheptene, antidepressanti, prodotti antikonvulżivi).
English: Pre-filled pen containing 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.
Maltese: Soluzzjoni ta' 1.5 mL f'siringa tal-ħġieġ ta' Tip I ta' 2.25 mL b'tapp tal-planġer (lastku bromobutyl) u labra.
English: Patients had a median age of 41 years (range: 18 to 70 years), 88% were female, and 79% were white.
Maltese: Il-pazjenti kellhom età medjana ta' 41 sena (medda: 18 sa 70 sena), 88% kienu nisa u 79%
English: LS Mean (+/- SE) Change from Baseline
Maltese: Bidla Medja ta' LS (+/- SE) mil-Linja Bażi
English: A total of 1,130 patients (991 females, 139 males) were randomised into one of three arms: 675 mg fremanezumab starting dose followed by 225 mg fremanezumab once a month (monthly, n=379), 675 mg fremanezumab every three months (quarterly, n=376), or monthly administration of placebo (n=375) administered via subcutaneous injection.
Maltese: Total ta' 1,130 pazjent (991 mara, 139 raġel) intgħażlu b'mod każwali għal wieħed minn tliet gruppi: doża tal-bidu ta' 675 mg fremanezumab segwita minn 225 mg fremanezumab darba fix-xahar (kull xahar, n=379), 675 mg fremanezumab kull tliet xhur (kull tliet xhur, n=376), jew għoti kull xahar ta' plaċebo (n=375) mogħti permezz ta' injezzjoni taħt il-ġilda.
English: A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine.
Maltese: Sustanza fil-ġisem imsejħa peptide relatat mal-ġene ta' calcitonin (CGRP, calcitonin gene-related peptide) għandha rwol importanti fl-emigranja.
English: Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: Fremanezumab hu antikorp monoklonali umanizzat magħmul fiċ-ċelluli tal-Ovarju tal-Ħamster Ċiniż
English: No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab.
Maltese: Mhux mistennija interazzjonijiet farmakokinetiċi tal-mediċina abbażi tal-karatteristiċi ta' fremanezumab.
English: Table 3: Key Efficacy Outcomes in Study 2 in Chronic Migraine Efficacy Endpoint
Maltese: Tabella 3: Riżultati Ewlenin tal-Effikaċja fi Studju 2 dwar l-Emigranja Kronika Punt Finali tal
English: The requirements for submission of PSURs 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 web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva
English: AJOVY Monthly AJOVY Quarterly
Maltese: AJOVY Kull Tliet Xhur AJOVY Kull Xahar
English: Available non-clinical data do not suggest an effect on fertility (see section 5.3).
Maltese: Data mhux klinika disponibbli ma tissuġġerixxix effett fuq il-fertilità (ara sezzjoni 5.3).
English: Patients had a median age of 42 years (range: 18 to 70 years), 85% were female, and 80% were white.
Maltese: Il-pazjenti kellhom età medjana ta' 42 sena (medda: 18 sa 70 sena), 85% kienu nisa u 80% kienu bojod.
English: Key secondary endpoints were the achievement of at least 50% reduction from baseline in monthly headache days of at least moderate severity (50% responder rate), mean change from baseline in the patient reported HIT-6 score, and change from baseline in monthly average number of days of acute headache medicinal product use.
Maltese: Punti finali sekondarji ewlenin kienu l-kisba ta' tnaqqis ta' mill-inqas 50% mil-linja bażifil-jiem ta' wġigħ ta' ras ta' severità mill-inqas moderata kull xahar (rata' ta' rispons ta' 50%), bidla medja mil-linja bażi fil-punteġġ HIT-6 irrappurtat mill-pazjenti, u bidla mil-linja bażi fin-numru medju ta' jiem ta' użu ta' prodott mediċinali għall-uġigħ ta' ras akut kull xahar.
English: A total of 875 patients (742 females, 133 males) were randomised into one of three arms: 675 mg fremanezumab every three months (quarterly, n=291), 225 mg fremanezumab once a month (monthly, n=290), or monthly administration of placebo (n=294) administered via subcutaneous injection.
Maltese: Total ta' 875 pazjent (742 mara, 133 raġel) intgħażlu b'mod każwali għal wieħed minn tliet gruppi: 675 mg fremanezumab kull tliet xhur (kull tliet xhur, n=291), 225 mg fremanezumab darba fix-xahar (kull xahar, n=290), jew għotja kull xahar ta' plaċebo (n=294) mogħti permezz ta' injezzjoni taħt il-ġilda.
English: Key secondary endpoints were the achievement of at least 50% reduction from baseline in monthly migraine days (50% responder rate), mean change from baseline in the patient reported MIDAS score, and change from baseline in monthly average number of days of acute headache medicinal product use.
Maltese: Punti finali sekondarji ewlenin kienu l-kisba ta' tnaqqis ta' mill-inqas 50% mil-linja bażi fil-jiem bl-emigranja kull xahar (rata ta' rispons ta' 50%), bidla medja mil-linja bażi fil-punteġġ MIDAS irrappurtat mill-pazjenti, u bidla mil linja bażi fin-numru medju ta' jiem ta' użu ta' prodott mediċinali għall-uġigħ ta' ras akut kull xahar.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: AJOVY 225 mg solution for injection in pre-filled syringe AJOVY 225 mg solution for injection in pre-filled pen
Maltese: AJOVY 225 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest AJOVY 225 mg soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest
English: c) Wait for 30 minutes to let AJOVY reach room temperature to reduce discomfort during injection.
Maltese: c) Stenna għal 30 minuta biex tippermetti lil AJOVY jilħaq it-temperatura tal-kamra sabiex tnaqqas l-iskonfort matul l-injezzjoni.
English: Fremanezumab selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α-and β-CGRP) from binding to the CGRP receptor.
Maltese: (CGRP, calcitonin gene-related peptide) u jimblokka ż-żewġ isoformi ta' CGRP (α-u β-CGRP) milli jeħlu mar-riċettur ta' CGRP.
English: Intrinsic and extrinsic factors
Maltese: Fatturi intrinsiċi u estrinsiċi
English: Steady state was achieved by approximately 168 days (about 6 months) following 225 mg monthly and 675 mg quarterly dosing regimens.
Maltese: L-istat fiss inkiseb sa bejn wieħed u ieħor 168 jum (madwar 6 xhur) wara korsijiet ta' dożaġġ ta' 225 mg kull xahar u 675 mg kull tliet xhur.
English: The efficacy of fremanezumab was assessed in two randomised, 12-week, double-blind, placebocontrolled phase III studies in adult patients with episodic (Study 1) and chronic migraine (Study 2).
Maltese: III fejn il-pazjenti ntgħażlu b'mod każwali, li damu 12-il ġimgħa, double-blind, ikkontrollati bil-plaċebo, f'pazjenti adulti b'emigranja episodika (Studju 1) u kronika (Studju 2).
English: There is limited data available on the use of fremanezumab in patients ≥65 years of age.
Maltese: Anzjani Hemm data limitata disponibbli dwar l-użu ta' fremanezumab f'pazjenti b'età ta' ≥65 sena.
English: When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber (see section 5.1).
Maltese: Meta tibda t-trattament bi fremanezumab, trattament preventiv għall-emigranja fl-istess waqt jista' jitkompla jekk ikun ikkunsidrat neċessarju mill-persuna li tippreskrivi (ara sezzjoni 5.1).