FrancophonIA/ELRC3.0 huggingface dataset:
English: HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = number of subjects in each group n = number of subjects reporting at least one event in each group 6M PI = 6-month persistent infection CI = Confidence Interval ASC-US= Atypical Cells of Undetermined Significance (abnormal cytology) (1) 3 doses of vaccine, DNA negative and seronegative at month 0 (unless specified) and DNA negative at month 6 for the relevant HPV type (HPV-16 and/or HPV-18) (2) at least one dose of vaccine, irrespective of HPV DNA and serostatus (unless specified) at month 0.
Maltese: Saru żewġ analiżi tal-istudju HPV-008: analiżi attivata minn avveniment saret darba fejn mill-inqas 36 każ ta' CIN2+ assoċjati ma' HPV-16/18 ġew miżjuda mal-grupp ta' ATP u f'analiżi fl-aħħar tal istudju.
English: Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
Maltese: (GMT) ikkawżati mill-vaċċin kienu ogħla minn titres osservati f'nisa li qabel kienu infettati iżda li nħelsu mill-infezzjoni HPV (infezzjoni naturali).
English: N = number of subjects included in each group (1) TVC naïve: includes all vaccinated subjects (who received at least one dose of vaccine) who had normal cytology, were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
Maltese: N = numru ta' individwi inklużi f'kull grupp (1) Ġodda għal TVC: jinkludi l-individwi li tlaqqmu kollha (li rċevew millanqas doża waħda tat-tilqima) li kellhom ċitoloġija normali, kienu negattivi għad-DNA ta' HPV għal 14-il tip onkoġeniku ta' HPV u seronegattivi għal HPV-16 u HPV-18 fil-linja bażi.
English: INSTRUCTIONS ON USE
Maltese: Effikaċja kontra
English: 1 dose (0.5 ml)
Maltese: 2 dożi (1 ml)
English: DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. - The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
Maltese: Hi-5 Rix4446 derivat mill-insett Trichoplusia ni.
English: Arthralgia
Maltese: Pożoloġija
English: The Total Vaccinated Cohort (TVC) included all subjects who received at least one dose of the vaccine, irrespective of their HPV DNA status, cytology and serostatus at baseline.
Maltese: Il-Grupp Totali Mlaqqam (Total Vaccinated Cohort (TVC)) kien jiġbor fih l-individwi kollha li rċivew mill-anqas doża waħda tat-tilqima, irrispettivament mill-istat tad-DNA ta' HPV tagħhom, ċitoloġija u stat tas-serum fil-linja bażi.
English: NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Cervarix suspension for injection in a vial
Maltese: TAL-PRODOTT MEDIĊINALI Cervarix, suspensjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Summary of the safety profile
Maltese: Effikaċja profilattika kontra
English: At the end of study analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 92.8% (95% CI: 87.1;96.4).
Maltese: Flanaliżi fl-aħħar tal-istudju, l-effikaċja tat-tilqima kontra CIN1 marbut ma' HPV 16/18 osservata filgrupp ATP kienet ta' 92.8% (95% CI: 87.1;96.4).
English: Unlike histopathological endpoints, virological endpoints are less confounded by multiple infections.
Maltese: B'kuntrast ma' endpoints istopatoloġiċi, endpoints viroloġiċi huma anqas imfixkla b'infezzjonijiet multipli.
English: Overall, 74% of women enrolled were naïve to both HPV-16 and HPV-18 (i.e. DNA negative and seronegative at study entry).
Maltese: Globalment, 74% tan-nisa li ddaħħlu fl-istudju kienu inġenwi kemm għal HPV-16 kif ukoll għal HPV18 (i.e. negattivi għad-DNAu seronegattivi meta ddaħħlu fl-istudju).
English: The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone.
Maltese: Meta Cervarix ingħata xahar wara dTpa-IPV kien hemm tendenza għal livell imnaqqas ta' GMTs ta' anti-HPV-16 u anti-HPV-18 meta mqabbel mat-teħid ta' Cervarix waħdu.
English: No information exists about protection against persistent infection or precancerous lesions among HIV infected women.
Maltese: Ma teżisti l-ebda informazzjoni dwar il-protezzjoni kontra infezzjoni persistenti jew leżjonijiet pre-kanċeroġeni fost nisa infettati bl-HIV.
English: Cervarix suspension for injection, multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Maltese: Cervarix, suspensjoni għall-injezzjoni, kontenitur b'ħafna dożi Vaċċin tal-Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħah, adsorbit)
English: Immunogenicity
Maltese: FARMAĊEWTIKU
English: Side effects that have been reported during marketed use of Cervarix include:
Maltese: Effetti sekondarji li ġew irrappurtati waqt l-użu ta' Cervarix fis-suq jinkludu:
English: Clinical efficacy in women aged 26 years and older The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial (HPV-015) that included a total of 5,778 women aged 26-72 years (median: 37.0 years).
Maltese: 015) li kienet tinkludi total ta' 5,778 mara b'età minn 26 sa 72 sena (medjana: 37.0 sena).
English: Cervarix is a vaccine intended to protect from the age of 9 years against the diseases caused by infection with Human Papillomaviruses (HPV).
Maltese: X'inhu Cervarix u għalxiex jintuża Cervarix hu vaċċin maħsub biex jipproteġi minn età ta' 9 snin kontra mard ikkawżat mill-infezzjoni bil-Papillomaviruses (HPV).
English: The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18.
Maltese: L-endpoint ta' effikaċja primarja kien il-frekwenza ta' infezzjoni b'HPV-16 u/jew HPV-18.
English: GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 9218 111
Maltese: Tel: + 39 (0)45 9218 111
English: In all age groups, GMTs remained at least 5- to 32-fold for HPV-16 and 3- to 14-fold for HPV-18 above those elicited in women who cleared a natural infection for both antigens.
Maltese: sa 14-il darba għal HPV-18 fuq dawk misjuba fin-nisa li nħelsu minn infezzjoni naturali għaż-żewġ antiġens.
English: At study completion, there were no cases of infection or histopathological lesions associated with HPV-16 or HPV-18 in the vaccine group in study HPV-023.
Maltese: Fl-aħħar tal-istudju, ma kienx hemm każijiet ta' infezzjoni jew leżjonijiet istopatoloġiċi assoċjati ma' HPV-16 jew HPV-18 fil-grupp tal-vaċċin fi studju HPV-023.
English: Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Maltese: Cervarix, suspensjoni għall-injezzjoni f'kunjett Vaċċin tal-Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
English: Cross protective efficacy
Maltese: Għatu protettiv tal-labra
English: There were five cases of 12-month persistent HPV-16/18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
Maltese: HPV-16, 1 HPV-18) fil-grupp ta' kontroll u każ 1
English: In a supplemental analysis, the efficacy of Cervarix was evaluated against HPV-16/18-related CIN3+.
Maltese: F'analiżi supplimentari, l-effikaċja ta' Cervarix ġiet stmata kontra CIN3+ marbuta ma'
English: • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Maltese: • sintomi gastrointestinali li jinkludu dardir, rimettar, dijarrea u uġigħ ta' żaqq
English: Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.
Maltese: HPV-16/18 f'nisa b'evidenza ta' infezzjoni b'HPV-16 jew HPV-18 meta ddaħħlu flistudju.
English: The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i.e. regardless of baseline cytology and HPV serological and DNA status.
Maltese: Fl-istudju f'Fażi III (studju 008) ġew irreġistrati nisa mingħajr pre-screening għal preżenza ta' infezzjoni b'HPV i.e bla ma kienu meqjusa ċ-ċitoloġija ta' linja bażi u s-seroloġija ta' HPV u l-istatus ta' DNA.
English: Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Maltese: Cervarix ma jagħtix protezzjoni minn mard ikkawżat minn HPV tipi 16 jew 18 jekk dawn diġà jkunu infettati bil-Papillomavirus Uman tip 16 jew 18 fiż-żmien tal-vaċċinazzjoni.
English: When a female or a male individual is vaccinated with Cervarix, the immune system (the body's natural defence system) will make antibodies against HPV types 16 and 18.
Maltese: Meta mara jew raġel jitlaqqam b'Cervarix, is-sistema immunitarja tal-ġisem (is-sistema ta' difiża naturali tal-ġisem) tipproduċi anti-korpi kontra t-tipi 16 u 18 ta' HPV.
English: 6.3 Shelf life
Maltese: III (HPV
English: Cervarix will only protect against diseases that are caused by HPV types 16 and 18 and to some extent against diseases caused by certain other oncogenic related HPV types (see section 5.1).
Maltese: Cervarix jipproteġi biss kontra l-mard li huwa kkawżat minn HPV ta' tipi 16 u 18 u sa ċertu punt kontra mard ikkawżat minn ċerti tipi ta' HPV onkoġeniċi oħra relatati magħhom (ara sezzjoni 5.1).
English: Immune response to Cervarix after the primary vaccination course
Maltese: Immunoġeniċità Rispons immuni għal Cervarix wara l-kors primarju ta' tilqim
English: EU/1/07/419/011 - pack of 10
Maltese: EU/1/07/419/010- pakkett ta' wieħed
English: The data showed comparable immunogenicity in males and females.
Maltese: Id-data uriet immunoġeniċità komparabbli fl-irġiel u fin-nisa.
English: The primary endpoint was a combination of a virological and a histopathological endpoint: HPV16/18 related 6-month persistent infection and/or CIN1+.
Maltese: L-endpoints sekondarji kienu jinkludu infezzjoni persistenti għal 6 xhur u 12-il xahar.
English: endpoint
Maltese: Wavre
English: These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer).
Maltese: - kanċer ċervikali (kanċer fl-għonq ta' l-utru i.e in-naħa t'isfel ta' l-utru) u kanċer anali, - feriti ta' qabel il-kanċer tal-għonq tal-utru, vulvari, vaġinali u anali (bidliet fiċ-ċelluli ġenitali jew anali b'riskju li jwasslu għal kanċer).
English: Prophylactic efficacy against HPV-16/18 infection in a population naïve to oncogenic HPV types
Maltese: Effikaċja profilattika kontra infezzjoni b'HPV-16/18 f'popolazzjoni mingħajr esperjenza ta' tipi HPV onkoġeniċi.
English: GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com
Maltese: Österreich GlaxoSmithKline Pharma GmbHTel: + 43 (0)1
English: • headache
Maltese: • għejja
English: It may harm them,
Maltese: Emgality jiġi injettat taħt il-ġilda.
English: Important Information
Maltese: Informazzjoni Importanti
English: N = number of patients; CI95 % = 95 % confidence interval.
Maltese: N = numru ta' pazjenti; CI95 % = 95 % intervall ta' kunfidenza.
English: Sesto Fiorentino (FI) Italy
Maltese: Sesto Fiorentino (FI) L-Italja
English: Gastrointestinal System
Maltese: Is-Sistema Gastrointestinali
English: Elderly (> 65 years)
Maltese: Anzjani (>65 sena)
English: Age, sex, weight, race, ethnicity
Maltese: Età, sess tal-persuna, piż, razza u etniċità
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel:
Maltese: S.A Pārstāvniecība Latvijā Tel:
English: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
Maltese: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), L-Italja.
English: Date of first authorisation: 14 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 14 Novembru 2018
English: 77.8 % of patients completed the treatment period.
Maltese: 77.8 % tal-pazjenti temmew il-perjodu ta' trattament.
English: Store in a refrigerator (2 °C to 8 °C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000).
English: EVOLVE-2 - Episodic Migraine
Maltese: EVOLVE-2 - Emigranja episodika
English: Galcanezumab binds to CGRP with high affinity (KD = 31 pM) and high specificity (> 10,000-fold vs related peptides adrenomedullin, amylin, calcitonin and intermedin).
Maltese: Galcanezumab jintrabat ma' CGPR b'affinità kbira (KD = 31 pM) u bi speċifiċità kbira (>10,000 darba aktar vs il-peptides relatati adrenomedullin, amylin, calcitonin u intermedin).
English: EVOLVE-1 - Episodic Migraine
Maltese: EVOLVE-1 - Emigranja episodika
English: 3 Inject
Maltese: 3 Injetta
English: The active substance is galcanezumab.
Maltese: Is-sustanza attiva hija galcanezumab.
English: Less than 2.5 % of patients in these studies discontinued due to adverse events.
Maltese: Inqas minn 2.5 % tal-pazjenti f'dawn l-istudji waqfu minħabba avvenimenti avversi.
English: Click
Maltese: Klikk
English: The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation (1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %).
Maltese: 1 %/11.6 %), reazzjonijiet fil-post tal-injezzjoni (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), stitkezza (1.0 %/1.5 %), ħakk (0
English: Store in a refrigerator (2 ºC - 8 ºC).
Maltese: Aħżen fi friġġ (2 ºC - 8 ºC).
English: Medicine
Maltese: MEDIĊINALI
English: ImClone Systems LLC 33 ImClone Drive Branchburg New Jersey NJ 08876
Maltese: ImClone Systems LLC 33 ImClone Dr., Branchburg
English: 96 cases describing hypersensitivity reactions, anaphylactic reactions or angioedema were identified (29 serious, 0 fatal outcomes); 18 cases (14 serious, 4 non-serious) qualified under the anaphylactic reaction SMQ, 40 cases qualified under the angioedema SMQ (narrow) and 36 cases described as rash.
Maltese: Ġew identifikati 96 każ li jiddeskrivu reazzjonijiet ta' sensittività eċċessiva, reazzjonijiet anafilattiċi jew anġjoedima (29 serji, 0 b'eżitu fatali); 18-il każ (14 serji, 4 mhux serji) ikkwalifikaw taħt l-SMQ ta' reazzjoni anafilattika, 40 każ ikkwalifikaw taħt l-SMQ anġjoedima (dejqa) u 36 każ kienu deskritti bħala raxx.
English: MIDAS Total Scoree
Maltese: Punteġġ Totali MIDAS
English: Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the galcanezumab clinical trials.
Maltese: Pazjenti b'avvenimenti kardjovaskulari akuti riċenti (inklużi MI, anġina mhux stabbli, CABG, puplesija, DVT) u/jew dawk meqjusa li qegħdin f'riskju kardjovaskulari serju ġew esklużi mill-provi kliniċi ta' galcanezumab.
English: Over 72 % of patients completing the study reported a 50 % reduction in MHDs at month 12.
Maltese: Aktar minn 72 % tal-pazjenti li temmew l-istudju rrappurtaw tnaqqis ta' 50 % fl-MHDs fixxahar 12.
English: seconds
Maltese: sekondi
English: REGAIN - Chronic Migraine Emgality
Maltese: REGAIN - Emigranja Kronika Emgality
English: Pharmacotherapeutic group: analgesics, other antimigraine preparations, ATC code: N02CX08
Maltese: Kategorija farmakoterapewtika: analġeżiċi, preparazzjonijiet oħra kontra l-emigranja, Kodiċi ATC:
English: Monthly doses of 120 mg or 240 mg achieved a steady-state Cmax (Cmax, ss) of approximately 28 μg/mL (35 % CV) or 54 μg/mL (31 % CV), respectively.
Maltese: Dożi ta' 120 mg jew 240 mg fix-xahar kisbu Cmax fl-istat fiss (Cmax, ss) ta' madwar 28 μg/mL (35 % CV) jew 54 μg/mL (31 % CV), rispettivament.
English: For a more comfortable injection, leave the syringe at room temperature for 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli s-siringa f'temperatura tal-kamra għal 30 minuta qabel tinjetta.
English: ≥ 75 % MHD Responders Percentage, % P-value
Maltese: ≥ 75 % Pazjenti b'MHD li rrispondew
English: MIDAS Total Score N
Maltese: Punteġġ Totali MIDASe N
English: Serious hypersensitivity
Maltese: Sensittività eċċessiva serja
English: Vertigo may occur following the administration of galcanezumab (see section 4.8).
Maltese: Tista' tbati mill vertiġini wara li jingħata galcanezumab (ara sezzjoni 4.8).
English: Reporting of side effects
Maltese: Rappurtar ta' effetti sekondarji
English: • Insert the needle at a 45 degree angle.
Maltese: • Daħħal il-labra f'angolu ta' 45 grad.
English: Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis.
Maltese: Aktar minn 2,500 pazjent kienu esposti għal galcanezumab fi studji kliniċi tal-profilassi tal-emigranja.
English: Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: Completion rate of the double-blind treatment phase for patients who received galcanezumab ranged from 82.8 % to 87.7 %.
Maltese: Għall-pazjenti li rċevew galcanezumab, ir-rata ta' pazjenti li spiċċaw il-fażi ta' trattament fejn la l-investigaturi u lanqas il-pazjenti ma kienu jafu liema sustanza qed tintuża kienet tvarja minn 82.8 % sa 87.7 %.
English: The baseline scores of the MIDAS reflected severe migraine related disability of patients in EVOLVE-1 and EVOLVE-2 (mean of 33.1) and a very severely disabled population (mean of 67.2) in REGAIN.
Maltese: irriflettew id-diżabilità severa marbuta mal-emigranja tal-pazjenti f'EVOLVE-1 u EVOLVE-2 (medja ta' 33.1) u popolazzjoni b'diżabilità severa ħafna (medja ta' 67.2) f'REGAIN.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, L-Olanda
English: Parts of the Emgality Syringe
Maltese: Partijiet tas-Siringa Emgality
English: Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance of galcanezumab.
Maltese: bilirubin jew it-tneħħija tal-kreatinina Cockcroft-Gault (firxa: 24 sa 308 mL/min) ma influwenzawx ittneħħija apparenti ta' galcanezumab b'mod sinifikanti.
English: Emgality can potentially cause serious allergic reactions.
Maltese: Huwa possibbli li Emgality jikkawża reazzjonijiet allerġiċi serji.
English: In pooled data from studies EVOLVE-1 and EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001).
Maltese: F'data kollettiva mill-istudji EVOLVE-1 u EVOLVE-2, aktar minn 19 % tal-pazjenti ttrattati b'galcanezumab żammew rispons ta' ≥ 50 % minn Xahar 1 sa Xahar 6 versus 8 % tal-pazjenti fuq plaċebo (p < 0.001).
English: Other side effects that have been reported.
Maltese: Effetti sekondarji oħra li ġew irrappurtati.
English: Emgality 120 mg injection galcanezumab Subcutaneous use
Maltese: Emgality 120 mg injezzjoni galcanezumab
English: The efficacy and safety of galcanezumab has been studied in 3 phase 3, randomized, placebocontrolled, double-blind studies in adult patients (N = 2886).
Maltese: L-effikaċja u s-sigurtà ta' galcanezumab ġiet studjata fi 3 studji, arbitrarji, ta' fażi 3, ikkontrollati bilplaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, li saru f'pazjenti adulti (N=2886).
English: Other medicines and Emgality
Maltese: Mediċini oħra u Emgality
English: This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say it is essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża ta' 120 mg, i.e., huwa essenzjalment “bla sodium”.
English: EU/1/18/1330/003 EU/1/18/1330/004 EU/1/18/1330/006
Maltese: EU/1/18/1330/003 EU/1/18/1330/004
English: The 120 mg dose was associated with a statistically significant reduction in disability over placebo.
Maltese: Id-doża ta' 120 mg kienet assoċjata ma' tnaqqis statistikament sinifikant fid-diżabilità meta mqabbla ma' plaċebo.
English: - Keep this leaflet.
Maltese: Għatu tal labra
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80, water for injections.
Maltese: L-histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80, ilma għall-injezzjonijiet.
English: Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling.
Maltese: L-aktar termini rrapurtati b'mod frekwenti (≥1%) kienu: Reazzjoni fil-post tal-injezzjoni, Eritema fil-post tal-injezzjoni, Prurite fil-post tal-injezzjoni, Tbenġil fil-post tal-injezzjoni, Nefħa fil-post tal-injezzjoni.
English: As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Maltese: IgG4 umanizzat, galcanezumab huwa mistenni li jiddiżintegra f'peptides u aċidi amminiċi żgħar permezz ta' sensiela ta' reazzjonijiet kataboliċi bl-istess mod bħal IgG endoġenu.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Maltese: Pazjenti b'ċertu mard kardjovaskulari serju ġew esklużi mill-istudji kliniċi (ara sezzjoni 5.1).
English: The 2 episodic migraine studies (EVOLVE-1 and EVOLVE-2) enrolled patients who met International Classification of Headache Disorders (ICHD) criteria for a diagnosis of migraine with or without aura with 4-14 migraine headache days per month.
Maltese: Iż-2 studji ta' emigranja episodika (EVOLVE-1 u EVOLVE-2) irreġistraw fihom pazjenti li ssodisfaw il-kriterji tal-Klassifika Internazzjonali tad-Disturbi tal-Uġigħ ta' Ras (ICHD, International Classification of Headache Disorders) għal dijanjosi tal-emigranja bl-awra jew mingħajra b'4-14 il-jum ta' uġigħ ta' ras tal-emigranja kull xahar.
English: MHD with Acute Medication Use Baseline Mean Change Treatment Difference
Maltese: MHD b'Użu ta' Medikazzjoni Akuta Linja bażi
English: Handle it carefully.
Maltese: Ġorrha b'attenzjoni.
English: EU/1/18/1330/003 (1 pre-filled syringe) EU/1/18/1330/004 (3 pre-filled syringes) EU/1/18/1330/006 (2 pre-filled syringes)
Maltese: EU/1/18/1330/003 (siringa 1 mimlija għal-lest) EU/1/18/1330/004 (3 siringi mimlijin għal-lest) EU/1/18/1330/006 (2 siringi mimlijin għal-lest)
English: Galcanezumab exposure increases proportionally with dose.
Maltese: L-espożizzjoni għal galcanezumab tiżdied fi proporzjon mad-doża.
English: Renal impairment/hepatic impairment
Maltese: Indeboliment tal-kliewi/indeboliment tal-fwied
English: Across the 3 studies, patients were predominantly female (> 83 %) with a mean age of 41 years, and an average migraine history of 20 to 21 years.
Maltese: Fit-3 studji, il-pazjenti kienu l-aktar nisa (> 83 %) b'età medja ta' 41 sena, u storja medja ta' emigranja ta' 20 sa 21 sena.
English: Emgality contains sodium
Maltese: Emgality fih is-sodium
English: Based on a population PK analysis, the apparent volume of distribution of galcanezumab was 7.3 L. Biotransformation
Maltese: Abbażi ta' analizi PK ta' popolazzjoni, il-volum ta' distribuzzjoni apparenti ta' galcanezumab kien 7.3 L.
English: In patients failing two or more prophylactic treatments, the treatment difference was4.48 days (p < 0.001) between 120 mg and placebo and -1.86 days (p < 0.01) between 240 mg and placebo.
Maltese: F'pazjenti li fallew żewġ trattamenti profilattiċi jew aktar, id-differenza tat-trattament kienet -4.48 jum (p < 0.001) bejn 120 mg u plaċebo u -1.86 jum (p < 0.01) bejn 240 mg u plaċebo.
English: At Gestational Day 29, in rabbit embryo-foetal development toxicity study skull anomaly was found in one male foetus from mother treated with galcanezumab at an exposure approximately 33 times the human exposure at 240 mg.
Maltese: Fil-Jum Ġestazzjonali 29, fl-istudju tal-iżvilupp tat-tossiċità fl-embriju u fil-fetu tal-fenek instabet anomalija fil-kranju ta' fetu maskili wieħed minn omm ittrattata b' galcanezumab f'espożizzjoni ta' madwar 33 darba l-espożizzjoni umana ta' 240 mg.