FrancophonIA/ELRC3.0 huggingface dataset:
English: Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30 °C.
Maltese: Emgality jista' jinħażen sa 7 ijiem barra mill-friġġ meta jinħażen f'temperaturi sa 30°C.
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.
Maltese: Din il-mediċina m'għandiex tingħata lill-tfal u adolexxenti ta' taħt it-18-il sena minħabba li ma ġietx studjata f'dan il-grupp ta' età.
English: Packs of 1, 2 or 3 pre-filled pens.
Maltese: Pakketti ta' 1, 2 jew 3 pinen mimlijin għal-lest.
English: • The grey syringe plunger should be pushed all the way to end of the syringe.
Maltese: • Terġax tpoġġi l-għatu tal-labra lura fuq is-siringa.
English: In a juvenile toxicology study in which rats were administered galcanezumab twice weekly from Postnatal Day 21 through 90, systemic effects were limited to reversible, minimal, nonadverse decreases in total bone mineral content and bone mineral density at exposures approximately 50 times the human exposure at 240 mg.
Maltese: Wara t-Twelid, effetti sistemiċi kienu limitati għal tnaqqis, li kien riversibbli, minimu u mhux avvers, fit-total tal-kontenut tal-minerali tal-għadam u fid-densità tal-għadam f'esponimenti ta' madwar 50 darba l-esponiment fil-bniedem ta' 240 mg.
English: The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride and water for injections.
Maltese: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride u ilma għall-injezzjonijiet.
English: 1 pre-filled syringe 3 pre-filled syringes 2 pre-filled syringes
Maltese: 3 siringi mimlijin għal-lest 2 siringi mimlijin għal-lest
English: The impact of migraine on functioning was assessed by the Role Function-Restrictive domain of the Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1, and by the Migraine Disability Assessment (MIDAS) Questionnaire.
Maltese: Funzjoni ta' Rwol u permezz tal-Kwestjonarju dwar l-Istima tad-Diżabilità tal-Emigranja (MIDAS, Migraine Disability Assessment).
English: Abdomen
Maltese: Addome
English: Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP).
Maltese: Emgality fih galcanezumab, mediċina li twaqqaf l-attività ta' sustanza li tinsab b'mod naturali filġisem msejħa peptide relatat mal-ġene ta' calcitonin (CGRP, calcitonin gene-related peptide).
English: Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported.
Maltese: Ġew irrapportati reazzjonijiet serji ta' sensittività eċċessiva li jinkludu każijiet ta' anafilassija, anġjoedima u urtikarja.
English: You will hear a second click in about 5 to 10 seconds after the first one.
Maltese: Inti se tisma' t-tieni klikk f'madwar 5 sa 10 sekondi wara l-ewwel waħda.
English: Studies EVOLVE-1 and EVOLVE-2 had a 6 month, double-blind, placebo-controlled treatment period.
Maltese: Emigranja episodika L-istudji EVOLVE-1 u EVOLVE-2 kellhom perjodu ta' trattament ta' 6 xhur ikkontrollat bi plaċebo,
English: • Periodic Safety Update Reports (PSURs)
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSURs) Ir-rekwiżiti biex jiġu ppreżentati
English: Taking into account the PRAC Assessment Report on the PSUR(s) for galcanezumab, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal galcanezumab, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) thus preventing its biological activity.
Maltese: IgG4 umanizzat li jorbot miegħu il-peptide relatat mal ġene tal-calcitonin (CGRP, calcitonin gene-related peptide) u b'hekk jevita l-attività bijoloġika tiegħu.
English: Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of galcanezumab.
Maltese: Ma sarux studji mhux kliniċi biex jistmaw il-potenzjal karċinoġeniku u mutaġeniku ta' galcanezumab.
English: In patients failing two or more prophylactic treatments, the treatment difference was -2.64 days (p < 0.001) between 120 mg and placebo and -3.04 days (p < 0.001) between 240 mg and placebo.
Maltese: F'pazjenti li fallew żewġ trattamenti profilattiċi jew aktar, id-differenza tat-trattament kienet -2.64 jum (p < 0.001) bejn 120 mg u plaċebo u -3.04 jum (p < 0.001) bejn 240 mg u plaċebo.
English: In this patients, the treatment difference observed between galcanezumab 120 mg and placebo and between galcanezumab 240 mg and placebo for the reduction of MHDs in these patients was respectively2.53 days (p < 0.001) and -2.26 days (p < 0.001).
Maltese: Id-differenza tat-trattament osservata bejn galcanezumab 120 mg u plaċebo u bejn galcanezumab 240 mg u plaċebo għat-tnaqqis ta' MHDs f'dawn il-pazjenti kienet rispettivament -2.53 jum (p < 0.001) u -2.26 jum (p < 0.001).
English: The medicine inside should be clear.
Maltese: Il-mediċina ġewwa għandha tkun trasparenti.
English: ≥ 50 % MHD Responders Percentage, % P-value
Maltese: % Pazjenti b'MHD li rrispondew
English: The cumulative review of the data, taking into account pharmacological plausibility, temporal association to treatment and a general lack of confounding factors, concluded that anaphylaxis, angioedema, and rash should be added as new adverse drug reactions in the SmPC and package leaflet of galcanezumab.
Maltese: L-evalwazzjoni kumulattiva tad-dejta, meta tieħu f'kunsiderazzjoni l-plawsibilità farmakoloġika, l assoċjazzjoni bejn iż-żmien u t-trattament u n-nuqqas in ġenerali ta' fatturi ta' kumplikazzjoni, ikkonkludiet li anafilassija, anġjoedima u raxx għandhom jiżdiedu bħala reazzjonijiet avversi ġodda għall-mediċina fl-SmPC u l-fuljett ta' tagħrif ta' galcanezumab.
English: Renal elimination of IgG monoclonal antibody is low.
Maltese: L-eliminazzjoni tal-antikorp monoklonali
English: Grey Syringe Plunger
Maltese: Planġer Griż tas-Siringa
English: Grey syringe plunger
Maltese: Planġer griż tas-siringa
English: In the clinical studies, the incidence of anti-drug antibody development during the double-blind treatment phase was 4.8 % in patients receiving galcanezumab once monthly (all but one of whom had in vitro neutralizing activity).
Maltese: Fl-istudji kliniċi, l-inċidenza tal-iżvilupp tal-antikorpi kontra l-mediċina matul il-fażi tat-trattament fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienet 4.8 % talpazjenti li kienu qed jirċievu galcanezumab darba fix-xahar (li kollha ħlief wieħed kellhom attività li tinnewtralizza in vitro).
English: No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume of distribution of galcanezumab.
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża abbażi tal-età (18 sa 65 sena), sess tal-persuna, piż, razza jew etniċità minħabba li ma hemm l-ebda effett b'sinifikat kliniku ta' dawn il-fatturi fuq ittneħħija apparenti jew il-volum apparenti ta' distribuzzjoni ta' galcanezumab.
English: Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the maximum serum concentration (Cmax) of galcanezumab was approximately 30 μg/mL (27 % coefficient of variation, (CV)) and the time to Cmax was 5 days postdose.
Maltese: Abbażi ta' analiżi farmakokinetika (PK) ta' popolazzjoni, wara d-doża l-kbira ta' 240 mg ilkonċentrazzjoni massima ta' galcanezumab fis-serum (Cmax) kienet madwar 30 μg/mL (koeffiċjent ta'
English: Pack sizes of 1, 2 or 3 pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' 1, 2 jew 3 siringi mimlijin għal-lest.
English: In patients who failed one or more prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and placebo was -3.54 days (p < 0.001) and between galcanezumab 240 mg and placebo -1.37 days (p < 0.05).
Maltese: F'pazjenti li fallew trattament profilattiku wieħed jew aktar għal raġunijiet ta' effikaċja, id-differenza tat-trattament għat-tnaqqis fil-medja ta' MHDs fix-xahar osservata bejn galcanezumab 120 mg u plaċebo kienet -3.54 jum (p < 0.001) u bejn galcanezumab 240 mg u plaċebo kienet -1.37 jum
English: Patients received placebo, galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 240 mg/month and were allowed to use medication for the acute treatment of migraine.
Maltese: Il-pazjenti rċivew plaċebo, galcanezumab 120 mg/xahar (bid-doża akbar tal-bidu ta' 240 mg għallewwel xahar) jew galcanezumab 240 mg/xahar u tħallew jużaw mediċini għat-trattament akut talemigranja.
English: Figure 1 Reduction in monthly migraine headache days over time in studies EVOLVE-1 and EVOLVE-2
Maltese: Effikaċja u evalwazzjonijiet tar-riżultat irrapportati mill-pazjent EVOLVE-1 - Emigranja episodika
English: The overall mean reduction from baseline in the number of monthly MHDs averaged over the treatment phase was 5.6 days for the 120 mg dose group and 6.5 days for the 240 mg dose group.
Maltese: It-tnaqqis totali medju mil-linja bażi fin-numru ta' MHDs fix-xahar b'medja ikkalkulata matul il-fażi ta' trattament kien 5.6 jum għall-grupp tad-doża ta' 120 mg u 6.5 jum għall-grupp tad-doża ta' 240 mg.
English: Based on a population PK analysis that included doses ranging from 5 - 300 mg, the rate of absorption, apparent clearance and apparent volume of distribution was independent of dose.
Maltese: Abbażi ta' analiżi PK ta' popolazzjoni li kienet tinkludi dożi li jvarjaw minn 5 - 300 mg, ir-rata ta' assorbiment, tneħħija apparenti u volum apparenti ta' distribuzzjoni kienet indipendenti mid-doża.
English: Injection site reactionsa a
Maltese: Reazzjonijiet fil-post tal-injezzjonia a
English: No effects on fertility parameters such as oestrous cycle, sperm analysis, or mating and reproductive performance were observed in rats that were administered galcanezumab (exposures approximately 4 to 20 times the human exposure at 240 mg).
Maltese: Ma kienu osservati l-ebda effetti fuq il-parametri tal-fertilità bħaċ-ċiklu tal-estrus, l-analiżi talisperma, jew it-tgħammir u l-eżekuzzjoni riproduttiva fil-firien li ngħataw galcanezumab (esponimenti madwar 4 sa 20 darba aktar mill-esponiment fil-bniedem b'240 mg).
English: More patients treated with galcanezumab achieved clinically significant levels of improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) compared with those treated with placebo.
Maltese: Aktar pazjenti ttrattati b'galcanezumab kisbu livelli ta' titjib fil-funzjoni li kienu klinikament sinifikanti (rata ta' persuni li rrispondew abbażi ta' dik il-parti li tikkonċerna r- Restrizzjoni ta' Funzjoni ta' Rwol tal-MSQ) meta mqabbla ma dawk trattati bilplaċebo.
English: Choose your injection site
Maltese: Riżultati ta' Effikaċjaa
English: 1 Uncap
Maltese: Komuni ħafna
English: The majority of events related to the injection site were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction.
Maltese: Il-parti l-kbira tal-avvenimenti marbuta mal-post tal-injezzjoni kienu minn ħfief sa moderati u anqas minn 0.5% tal-pazjenti esposti għal galcanezumab matul l-istudji ta' fażi 3 waqqfu t-trattament minħabba reazzjoni fil-post tal-injezzjoni.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of galcanezumab have not been conducted.
Maltese: Ma sarux studji kliniċi speċifiċi dwar sigurtà farmakoloġika biex jevalwaw l-effetti ta' indeboliment tal-kliewi u indeboliment tal-fwied fuq il-PK ta' galcanezumab.
English: Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Galcanezumab huwa antikorp monoklonali
English: Mean Change
Maltese: Tqala u treddigħ
English: Syringe Body with Medicine
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.
Maltese: Ma hemm l-ebda użu rilevanti għal galcanezumab fi tfal taħt l-età ta' 6 snin għall-prevenzjoni talemigranja.
English: In pooled data from studies EVOLVE-1 and EVOLVE-2, in patients who failed one or more prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and placebo was -2.69 days (p < 0.001) and between galcanezumab 240 mg and placebo -2.78 days (p < 0.001).
Maltese: MHDs fix-xahar osservata bejn galcanezumab 120 mg u plaċebo kienet -2.69 jum (p < 0.001) u bejn galcanezumab 240 mg u plaċebo -2.78 jum (p < 0.001).
English: Buttock Thigh
Maltese: Jekk tieqaf tuża Emgality
English: Anaphylaxis Angioedema
Maltese: Anġjoedima
English: Patients > 65 years of age were also excluded.
Maltese: Pazjenti li kellhom aktar minn > 65 sena ġew esklużi wkoll.
English: While urticaria is uncommon, serious cases of urticaria have been reported in galcanezumab clinical studies.
Maltese: Filwaqt li l-urtikarja mhijiex komuni, ġew irrappurtati każijiet serji ta' urikarja fi studji kliniċi b'galcanezumab.
English: EXP
Maltese: Fuq
English: There is no evidence to suggest that chronic treatment with galcanezumab would increase the risk of carcinogenesis based on data from pharmacology and chronic toxicology studies with galcanezumab, as well as an assessment of the literature regarding CGRP.
Maltese: Ma hemm l-ebda xhieda li tissuġġerixxi li trattament kroniku b'galcanezumab iżid ir-riskju ta' karċinoġenesi abbażi ta' dejta minn studji ta' farmakoloġija u tossikoloġija kronika b'galcanezumab,
English: Approximately 15 % of the patients continued concurrent treatment with topiramate or propranolol as allowed by the protocol for prophylaxis of migraine.
Maltese: Madwar 15 % tal-pazjenti komplew bit-trattament ta' topiramate jew propranolol fl-istess ħin kif kien permess mill-protokol għall-profilassi tal-emigranja.
English: Injection site location (abdomen, thigh, buttocks and arm) did not significantly influence the absorption of galcanezumab.
Maltese: Il-post fejn ingħatat l-injezzjoni (l-addome, il-koxxa, il-warrani u d-driegħ) ma influwenzax b'mod sinifikanti l-assorbiment ta' galcanezumab.
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Maltese: IgG uman huwa magħruf li jiġi eliminat fil-ħalib tas-sider matul l-ewwel jiem wara t-twelid, li malajr wara jkun qed jonqos għal konċentrazzjonijiet baxxi; konsegwenza ta' dan, ma jistax jiġi eskluż riskju għat-trabi li jkunu qed jitreddgħu matul dan il-perjodu qasir.
English: Rare
Maltese: Labra
English: The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' galcanezumab fi tfal li għandhom minn 6 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: Before you use the EMGALITY syringe, read and carefully follow all the step-by-step instructions.
Maltese: Sinjal ta' reazzjonijiet ta' sensittività eċċessiva, abbażi ta' każijiet irrapportati minn sorsi spontanji ta'
English: Pruritus Rash
Maltese: TAGĦRIF
English: The marketing authorisation holder (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 subsequent updates of the RMP.
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal
English: A. It is normal to have air bubbles in the pen.
Maltese: Huwa normali li jkollok bżieżaq tal-arja fil-pinna.
English: Emgality pre-filled syringe is for single use only and contains one dose of Emgality (120 mg).
Maltese: - Wara l-ewwel doża, inti tuża siringa waħda (120 mg) kull xahar.
English: The galcanezumab Cmax, ss at monthly doses of 120 mg is achieved after the 240 mg loading dose.
Maltese: Is-Cmax, ss ta' galcanezumab b'dożi ta' 120 mg fix-xahar tinkiseb wara dik tad-doża inizjali akbar ta' 240 mg.
English: Very common
Maltese: Mistoqsijiet Komuni
English: At Gestational Day 20, an increase in the number of foetuses and litters with short ribs and a decrease in the mean number of ossified caudal vertebrae occurred in the rat embryo-foetal toxicity development study at an exposure approximately 20 times the human exposure at 240 mg.
Maltese: Fil-Jum Ġestazzjonali 20, żieda fin-numru ta' feti u btien b'kustilji qosra u tnaqqis fil-medja ta' numru ta' vertebri kawdali ossifikati seħħet fl-istudju tal-iżvilupp tat-tossiċità fl-embriju u fil-fetu tal-far b'esponiment ta' madwar 20 darba aktar mill-esponiment fil-bniedem ta' 240 mg.
English: Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at all subsequent months up to month 6 (see Figure 1).
Maltese: Meta mqabbla mal-pazjenti ttrattati bil-plaċebo, il-pazjenti ttrattati b'galcanezumab 120 mg jew 240 mg kellhom medja ta' tnaqqis b'mod sinifikanti akbar fin-numru ta' MHDs fix-xahar mil-linja bażi, f'xahar 1 u fix-xhur sussegwenti l-oħra kollha sax-xahar 6 (ara figura 1).
English: Scoring ranges from 0 to 100, with higher scores indicating less impairment , that is, patients experience fewer restrictions on the performance of day-to-day activities.
Maltese: Il-punteġġi jvarjaw minn 0 sa 100, bil-punteġġi ogħla jindikaw funzjoni aħjar, jiġifieri, l-pazjenti jkollhom inqas restrizzjonijiet fuq l-eżekuzzjoni tal-attivitajiet ta' kuljum.
English: Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see Table 3).
Maltese: Meta mqabbel mal-plaċebo, iż-żewġ gruppi tat-trattament b'galcanezumab 120 mg u 240 mg urew titjib mil-linja bażi fuq il-bidla medja fl-MHD li kien statistikament sinifikanti u ta' sinifikat kliniku (ara Tabella 3).
English: Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see Table 2).
Maltese: Meta mqabbel mal-plaċebo, iż-żewġ gruppi tat-trattament b'galcanezumab 120 mg u 240 mg urew titjib mil-linja bażi fuq il-bidla medja fl-MHD li kien statistikament sinifikanti u ta' sinifikat kliniku (ara Tabella 2).
English: Ear and Labyrinth System
Maltese: Il-Widnejn u sSistema Labirintika
English: Efficacy Outcomesa MHD Baseline Mean Change Treatment Difference
Maltese: Bidla medja Differenza fit-trattament
English: 1 Uncap the Pen
Maltese: 1 Neħħi l-għatu tal-Pinna
English: Thumb Pad
Maltese: Armi l-pinna
English: Needle Cap
Maltese: Mnejn Jingħata
English: The syringe must not be shaken.
Maltese: Armi l-pinna u ġib oħra.
English: • Each pen is for ONE-TIME USE ONLY.
Maltese: • Tinjettax fl-istess post ta' qabel.
English: Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies conducted in rats and cynomolgus monkeys and safety pharmacology evaluations conducted in cynomolgus monkeys at exposures approximately 10 to 80 times higher than clinical exposures in patients receiving 240 mg.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Tagħrif mhux kliniku ibbażat fuq studji dwar effett tossiku minn dożi ripetuti li sar fil-far u fix-xadini cynomolgus u stimi ta' sigurtà farmakoloġika li saru fix-xadini cynomolgus b'esponiment ta' madwar 10 sa 80 darba aktar mill-esponiment fil-bnedmin li jkunu qed jirċievu 240 mg, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Common side effects (may affect up to 1 in 10 people): - Vertigo (a feeling of dizziness or “spinning”) - Constipation - Itching - Rash
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10):
English: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.
Maltese: Id-doża rrakkomandata hija 120 mg galcanezumab injettat taħt il-ġilda darba fix-xahar, b'doża kbira ta' 240 mg bħala d-doża inizjali.
English: Parts of the Emgality pen
Maltese: INFORMAZZJONI BIL-BRAILLE Emgality
English: Skin and Subcutaneous Tissue
Maltese: - Uġigħ fil-post tal-injezzjoni
English: Teal Plunger Rod
Maltese: Fejn Tqabbad is-Swaba
English: MSQ Role Function Restrictive Domain Respondersc N Percentage, % P-value
Maltese: Dawk li rrispondew għall-parti tal-MSQ li tikkonċerna r-restrizzjoni ta' funzjoni ta' rwol kienu definiti bħala dawk b'titjib ta' ≥ 17.14 -il punt għal
English: Baseline
Maltese: Anafilassija
English: Each pre-filled syringe contains 120 mg of galcanezumab in 1 mL.
Maltese: Kull siringa mimlija għal-lest fiha 120 mg of galcanezumab f'1 mL.
English: How to store Emgality
Maltese: X'fih Emgality
English: • When you are ready to inject, pull the needle cap off and throw it away in the bin.
Maltese: • Fejn se tinjetta oqros ftit ġilda bilmod u żommha.
English: Do not shake.
Maltese: Aħżen fi friġġ.
English: Lock/Unlock Symbols
Maltese: Sinjali Aqfel/Iftaħ
English: Each pre-filled syringe contains 120 mg of galcanezumab in 1 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 120 mg ta' galcanezumab f'soluzzjoni ta' 1 mL.
English: Teva Sweden AB
Maltese: Sverige Teva Sweden AB
English: TEVA Pharmaceuticals Slovakia s.r.oTel:
Maltese: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.oTel:
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 100 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola 100 pillola
English: Contains lactose monohydrate.
Maltese: Fiha lactose monohydrate.
English: Actavis UK Limited Tel: +44 1271 385257
Maltese: United Kingdom Actavis UK Limited Tel: +44 1271 385257
English: Latvija UAB "Sicor Biotech" filiāle Latvijā
Maltese: UAB "Sicor Biotech"
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Maltese: Kważi s-suġġetti kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi beta, inibituri ACE, antagonisti ta' angiotensin II, imblokkaturi talkanali tal-kalċju, nitrati, dijuretiċi, aspirina, statins, fibrates).
English: • Risk Management Plan (RMP)
Maltese: • Sistema ta' l-immaniġġar tar-riskju (RMP)
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista kompleta ta'sustanzi mhux attivi, ara sezzjoni 6.1.
English: - The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, hyprolose, carmellose calcium u magnesium stearate
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Maltese: Każijiet ta 'kanċer tal-bużżieqa tal-urina kienu rrappurtati b'mod aktar frekwenti f'meta-analiżi ta' provi kliniċi kkontrollati b'pioglitazone (19-il każ minn 12,506 pazjent, 0.15%) milli fil-gruppi ta' kontroll (7 każi minn 10,212 pazjent, 0.07%) HR = 2.64 (95% CI 1.11-6.31, p = 0.029).