FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP's recommendations were sent to the European Commission which endorsed them and issued a final, legally binding decision valid throughout the EU on 19 August 2014.
Maltese: Ir-rakkomandazzjonijiet tas-CHMP intbagħtu lill-Kummissjoni Ewropea li approvathom u ħarġet deċiżjoni finali li torbot legalment valida madwar l-UE fid-19 ta' Awissu 2014.
English: The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area.
Maltese: Il-krema Linoladiol N għandha tintuża biss ġewwa l-vaġina għall-kura ta' nisa wara l-menopawża b'atrofija vaġinali minħabba nuqqas tal-ormon estroġenu, filwaqt li l-krema Linoladiol HN hija għal nisa wara l-menopawża b'kundizzjonijiet infjammatorji ħfief tal-ġilda madwar iż-żona ġenitali.
English: The final CHMP opinion was forwarded to the European Commission, which issued a final decision on 19 August 2014.
Maltese: L-opinjoni finali tas-CHMP ġiet mgħoddija lill-Kummissjoni Ewropea li ħarġet deċiżjoni finali dwarha fid-19 ta' Awwissu 2014.
English: The European Medicines Agency has updated advice on how to use Linoladiol N and Linoladiol HN creams.
Maltese: L-Aġenzija Ewropea tal-Mediċini aġġornat pariri dwar l-użu tal-kremi Linoladiol N u Linoladiol HN.
English: • Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.
Maltese: • Linoladiol HN huwa maħsub għall-kura għal żmien qasir ta' mard infjammatorju ħafif u akut taż żona ġenitali esterna f'nisa wara l-menopawża.
English: • Linoladiol N is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of estrogen.
Maltese: • Linoladiol N huwa maħsub għall-kura ta' atrofija vaġinali minħabba nuqqas ta' estroġenu f'nisa wara l-menopawża.
English: • Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.
Maltese: • Kemm Linoladiol N kif ukoll Linoladiol HN ma għandhomx jintużaw għal aktar minn erba' ġimgħat minħabba r-riskji assoċjati ma' espożizzjoni sistemika possibbli għal estradiol.
English: • Linoladiol HN was previously being used to treat a condition called lichen sclerosus.
Maltese: • Linoladiol HN kien qiegħed jintuża għall-kura ta' kundizzjoni lichen sclerosus.
English: Linoladiol N and Linoladiol HN are a type of local ‘hormone replacement therapy': they contain a female hormone, estradiol, used to replace the estradiol hormone the body no longer makes after menopause.
Maltese: Linoladiol N u Linoladiol HN huma tip ta' ‘terapija għas-sostituzzjoni tal-ormoni': fihom ormon femminili, estradiol, użat biex jissostitwixxi l-omron estradiol li l-ġisem ma jibqax jagħmel wara l menopawża. Linoladiol HN fih ukoll prednisolone f'doża baxxa, li jaħdem bħala aġent antiinfjammatorju.
English: In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use.1 Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have been updated, taking into account new measures to manage the potential risk of side effects.
Maltese: F'Diċembru 2013, is-CHMP kien ikkonkluda reviżjoni tal-benefiċċji u riskju taż-żewġ kremi u għamel rakkomandazzjonijiet dwar l-użu tagħhom.1
English: The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use.
Maltese: Informazzjoni għall-professjonisti tal-kura tas-saħħa L-EMA kkonkludiet reviżjoni ta' Linoladiol N u Linoladiol HN kremi li fihom estradiol u aġġornat irrakkomandazzjonijiet dwar l-użu tagħhom.
English: (see section 5.2).
Maltese: (ara sezzjoni 5.2).
English: Important:
Maltese: Importanti:
English: Placebo (N=41)
Maltese: Plaċebo (N=41)
English: [mild, N=98] and 30 to 59 ml/min/1.73m
Maltese: [ħafif, N=98] u 30 sa 59 ml/min/1.73m
English: Endpoint statistics a
Maltese: Statistika tal-punt aħħari a
English: Lanadelumab is a fully human, monoclonal antibody (IgG1/ κ-light chain).
Maltese: Lanadelumab huwa antikorp monoklonali kompletament uman (IgG1/ κ-light chain).
English: There is no antidote available.
Maltese: M'hemm l-ebda antidotu disponibbli.
English: Criteria
Maltese: Kriterji
English: Alanine aminotransferase increased Common
Maltese: Żieda fl-alanine aminotransferase Komuni
English: Keeping a record
Maltese: Żomm rekord
English: Date of first authorisation: 22 November 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta 'Novembru 2018
English: See section 4.
Maltese: Pass 4.
English: % reduction relative to placebo corresponds to 100% * (1-rate ratio).
Maltese: c tnaqqis % meta mqabbel mal-plaċebo jikkorrispondi għal 100% * (1-proporzjon tar-rata).
English: Interference with coagulation test
Maltese: Interferenza mat-test tal-koagulazzjoni
English: The cHMWK formation rate was maximally reduced by 53.7% with an IC50 of 5705 ng/ml.
Maltese: Ir-rata ta' formazzjoni ta' cHMWK tnaqqset b'mod massimu bi 53.7% b'IC50 ta' 5705 ng/ml.
English: The percentage of patients who achieved a clinically meaningful improvement in AE-QoL total score was 65% (Odds ratio vs placebo, [95% CI]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), and 81% (7.2 [2.2, 23.4]), in TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, and 300 mg q2 wks groups, respectively, compared to 37% of patients in the placebo group.
Maltese: Il-perċentwali ta' pazjenti li kisbu titjib klinikament sinifikanti fil-punteġġ totali ta' AE-QoL kien ta' 65% (Proporzjon ta' probabbiltà vs plaċebo, [CI ta' 95%]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), u 81% (7.2 [2.2, 23.4]), fil-gruppi ta' TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, u 300 mg q2 wks, rispettivament, meta mqabbla ma' 37% tal-pazjenti fil-grupp tal-plaċebo.
English: Multipack: 6 vials (6 packs of 1 vial) of 2 ml.
Maltese: Pakkett multiplu: 6 kunjetti (6 pakketti ta' kunjett wieħed) ta' 2 ml.
English: Nutrition score Note: AE-QoL= Angioedema Quality of Life; LS=least squares; SD=standard deviation.
Maltese: Nota: AE-QoL= Kwalità tal-Ħajja b'Anġjoedima; LS=least squares;
English: TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4)
Maltese: TAKHZYRO mhuwiex maħsub għal trattament ta' attakki akuti ta' HAE (ara sezzjoni 4.4).
English: % Reduction relative to placebo (95% CI)
Maltese: Tnaqqis % meta mqabbel mal-plaċebo (CI ta' 95%)
English: Lanadelumab has a mean (SD) total body clearance of 0.0297 L/h (0.0124) and a terminal elimination half-life of approximately 14 days.
Maltese: Lanadelumab għandu tneħħija totali mill-ġisem medja (SD) ta' 0.0297 L/siegħa (0.0124) u half-life ta' eliminazzjoni terminali ta' madwar 14-il jum.
English: The frequency of adverse reactions listed in Table 1 is defined using 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 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); rari ħafna (< 1/10,000).
English: Note: CI=confidence interval; LS=least squares.
Maltese: LS=least squares.
English: Name and address of the manufacturer(s) of the biological active substance(s) Rentschler Biopharma SE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i Rentschler Biopharma SE
English: Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects.
Maltese: It-trattament b'lanadelumab ġie assoċjat ma' żvilupp ta' antikorpi kontra l-mediċina (ADA - anti-drug antibodies) li żviluppaw mat-trattament fi 11.9% (10/84) tal-individwi.
English: AE-QoL Total score
Maltese: Punteġġ totali ta' AE-QoL
English: A history of laryngeal angioedema attacks was reported in 65% (81/125) of subjects and 56% (70/125) were on prior long term prophylaxis (LTP).
Maltese: Passat ta' attakki ta' anġjoedima tal-larinġi kien irrappurtat f'65% (81/125) tal-individwi u 56% (70/125) kienu fuq profilassi fit-tul minn qabel (LTP - prior long-term prophylaxis).
English: A reduction of 6 points is considered a clinically meaningful improvement.
Maltese: Tnaqqis ta' 6 punti huwa kkunsidrat bħala titjib klinikament sinifikanti.
English: There were no differences in international normalised ratio (INR) between treatment groups.
Maltese: Ma kienx hemm differenzi fil-proporzjon normalizzat internazzjonali (INR - international normalised ratio) bejn il-gruppi ta' trattament.
English: If symptoms should occur, symptomatic treatment is recommended.
Maltese: F'każ li jseħħu sintomi, huwa rakkomandat trattament sintomatiku.
English: Accordingly, in a population pharmacokinetic analysis, renal impairment (estimated GFR: 60 to 89 ml/min/1.73 m
Maltese: Għaldaqstant, f'analiżi tal-farmakokinetika tal-popolazzjoni, l-indeboliment tal-kliewi (GFR stmata: 60 sa 89 ml/min/1.73 m
English: • The active substance is lanadelumab.
Maltese: Is-sustanza attiva hi lanadelumab.
English: 100% of the subjects on 300 mg q2wks or q4wks and 89% on 150 mg q4wks achieved at least a 50% reduction in HAE attack rate compared to the run-in period.
Maltese: 100% tal-individwi fuq 300 mg q2wks jew q4wks u 89% fuq 150 mg q4wks kisbu mill-inqas tnaqqis ta' 50% fir-rata ta' attakki ta' HAE meta mqabbla mal-perjodu ta' tħejjija.
English: The safety of TAKHZYRO was evaluated in a subgroup of 23 subjects aged 12 to <18 years old.
Maltese: Is-sigurtà ta' TAKHZYRO ġiet evalwata f'sottogrupp ta' 23 individwu b'età minn 12 sa <18-il sena.
English: TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Maltese: TAKHZYRO huwa indikat għall-prevenzjoni ta' rutina ta' attakki rikorrenti ta' anġjoedima ereditarja (HAE - hereditary angioedema) f'pazjenti b'età ta' 12-il sena jew aktar.
English: What hereditary angioedema (HAE) is
Maltese: X'inhi anġjoedima ereditarja (HAE - hereditary angioedema)
English: Multipack: 2 vials (2 packs of 1 vial) of 2 ml.
Maltese: 2 kunjetti (2 pakketti ta' kunjett wieħed) ta' 2 ml.
English: HAE is a condition which runs in families.
Maltese: HAE hija kondizzjoni li tingħadda fil-familji.
English: Adjusted p-values for multiple testing.
Maltese: Valuri p aġġustati għal ittestjar multiplu.
English: In the HELP study, patients treated with 300 mg q2 wks presented mean (SD) area under the curve over the dosing interval at steady-state (AUCtau,ss), maximum concentration at steady-state (Cmax,ss) and minimum concentration at steady-state (Cmin,ss) of 408 µg*day/ml (138), 34.4 µg/mL (11.2), and 25.4 µg/mL (9.18), respectively.
Maltese: Fl-istudju HELP, il-pazjenti ttrattati b'300 mg q2 wks ippreżentaw erja taħt il-kurva medja (SD) matul l-intervall ta' dożaġġ fi stat fiss (AUCtau,ss), konċentrazzjoni massima fi stat fiss (Cmax,ss) u konċentrazzjoni minima fi stat fiss (Cmin,ss) ta' 408 µg*jum/ml (138), 34.4 µg/mL (11.2), u 25.
English: Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%), see section 4.4.
Maltese: Ġiet osservata reazzjoni ta' sensittività eċċessiva (ħakk ħafif u moderat, skumdità u tnemnim talilsien) (1.2%), ara sezzjoni 4.4.
English: EU/1/18/1340/002 EU/1/18/1340/003
Maltese: EU/1/18/1340/002
English: Store in a refrigerator (2C-8C).
Maltese: Aħżen fi friġġ (2C-8C).
English: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay.
Maltese: Lanadelumab jista' jżid il-ħin ta' tromboplastin parzjali attivat (aPTT - activated partial thromboplastin time) minħabba interazzjoni ta' lanadelumab mal-assaġġ ta' aPTT.
English: The median (range) age of the study population was 42 (12 to 73) years with 88 female subjects (70%).
Maltese: L-età medjana (firxa) tal-popolazzjoni tal-istudju kienet ta' 42 (12 sa 73) sena bi 88 individwu mara (70%).
English: Store in a refrigerator (2C to 8C).
Maltese: Aħżen fi friġġ (2C sa 8C).
English: The percentage of subjects who were attack free is provided in Table 3.
Maltese: Il-perċentwali ta' individwi li ma kellhomx attakki huwa pprovdut fit-Tabella 3.
English: There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.
Maltese: M'hemmx data klinika disponibbli dwar l-użu ta' lanadelumab f'pazjenti b'HAE b'attività normali ta' C1-INH.
English: Do not use TAKHZYRO:
Maltese: Tużax TAKHZYRO:
English: Treatment period (Day 0 to Day 182, 26 weeks) n Attack free
Maltese: Perjodu ta' trattament (Jum 0 sa Jum 182, 26 ġimgħa)
English: TAKHZYRO contains sodium
Maltese: TAKHZYRO fih sodium
English: • The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and water for injections - see section 2 “TAKHZYRO contains sodium” What TAKHZYRO looks like and contents of the pack
Maltese: Is-sustanzi mhux attivi l-oħra huma disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 u ilma għall-injezzjonijiet - ara sezzjoni 2 “TAKHZYRO fih sodium”
English: TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein.
Maltese: TAKHZYRO huwa tip ta' proteina li timblokka l-attività ta' kallikrein fil-plażma.
English: Inject TAKHZYRO
Maltese: Injetta TAKHZYRO
English: The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE.
Maltese: L-istudju HELP kien studju bi grupp parallel, b'aktar minn ċentru wieħed, randomised, double-blind u kkontrollat bil-plaċebo f'125 (115-il adult u 10 adolexxenti) individwu b'HAE sintomatika tat-tip I
English: **Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
Maltese: *Sensittività eċċessiva tinkludi: ħakk, skumdità u tnemnim tal-ilsien. **Reazzjonijiet fis-sit tal-injezzjoni jinkludu: uġigħ, eritema, tbenġil, skumdità, ematoma, emorraġija, ħakk, nefħa, ebusija, paraesteżija, reazzjoni, sħana, edima u raxx.
English: Pregnancy and breast-feeding
Maltese: Punteġġ tan-nutrizzjoni
English: There is no available information to identify potential signs and symptoms of overdose.
Maltese: M'hemm l-ebda informazzjoni disponibbli biex jiġu identifikati sinjali u sintomi potenzjali ta' doża eċċessiva.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
Maltese: Is-soluzzjoni għandha pH ta' madwar 6.0 u ożmolalità ta' madwar 300 mOsm/kg.
English: From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately.
Maltese: Minn perspettiva mikrobijoloġika, sakemm il-metodu ta' preparazzjoni ma jipprekludix riskji ta' kontaminazzjoni mikrobika, il-prodott għandu jintuża immedjatament.
English: TAKHZYRO is a medicine used in adults, and adolescents aged 12 years and older to prevent angioedema attacks, in patients with HAE.
Maltese: TAKHZYRO huwa mediċina użata fl-adulti, u l-adolexxenti b'età ta' 12-il sena u aktar biex jipprevjeni attakki ta' anġjoedima, f'pazjenti b'HAE.
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 2°C to 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal sagħtejn f'temperatura ta' 25°C u għal 8 sigħat f'temperatura minn 2°C sa 8°C.
English: TAKHZYRO 300 mg solution for injection
Maltese: TAKHZYRO 300 mg soluzzjoni għall-injezzjoni
English: TAKHZYRO contains the active substance lanadelumab.
Maltese: TAKHZYRO fih is-sustanza attiva lanadelumab.
English: Adjusted p-values d
Maltese: Valuri p aġġustati d
English: Table 1: Adverse reactions reported with lanadelumab
Maltese: Tabella 1: Ir-reazzjonijiet avversi rrappurtati b'lanadelumab
English: [moderate, N=9]) had no effect on the clearance or volume of distribution of lanadelumab.
Maltese: [moderat, N=9]) ma kellu l-ebda effett fuq it-tneħħija jew il-volum ta' distribuzzjoni ta' lanadelumab.
English: • Muscle pain
Maltese: • Uġigħ fil-muskoli
English: Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.
Maltese: Abbażi tal-karatteristiċi ta' lanadelumab, mhux mistennija interazzjonijiet farmakokinetiċi ma' prodotti mediċinali mogħtija flistess waqt.
English: The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull ml ta' soluzzjoni, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: No dose adjustment is required for patients above 65 years of age (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fiddoża għal pazjenti b'età ta' aktar minn 65 sena (ara sezzjoni 5.2).
English: The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
Maltese: L-iżvilupp ta' ADA li jinkludi antikorpi newtralizzanti kontra TAKHZYRO ma deherx li jaffettwa b'mod negattiv il-profili farmakokinetiċi (PK - pharmacokinetic) u farmakodinamiċi (PDpharmacodynamic) jew ir-rispons kliniku.
English: Exposures in sexually mature cynomolgus monkeys in the fertility study were approximately 20-and 22-fold greater than that noted at 300 mg q2 wks based on Cmax and AUC, respectively.
Maltese: L-esponimenti f'xadini tat-tip cynomolgus sesswalment maturi fl-istudju dwar il-fertilità kienu madwar 20 u 22 darba akbar minn dak innotat bi 300 mg q2 wks abbażi tas-Cmax u l-AUC, rispettivament.
English: TAKHZYRO is intended for subcutaneous (SC) administration only.
Maltese: TAKHZYRO huwa intenzjonat għal għoti taħt il-ġilda (SC - subcutaneous) biss.
English: The PK-PD relationship between TAKHZYRO and cHMWK is described by an indirect exposureresponse pharmacological model.
Maltese: Ir-relazzjoni PK-PD bejn TAKHZYRO u cHMWK hija deskritta minn mudell farmakoloġiku ta' esponiment indirett-rispons.
English: The effects of lanadelumab on fertility were evaluated in sexually mature cynomolgus monkeys.
Maltese: L-effetti ta' lanadelumab fuq il-fertilità ġew evalwati f'xadini tat-tip cynomolgus sesswalment maturi.
English: Lanadelumab inhibits active plasma kallikrein proteolytic activity.
Maltese: Lanadelumab jinibixxi attività proteolitika attiva ta' kallikrein fil-plażma.
English: Subjects were randomized into 1 of 4 parallel treatment arms, stratified by baseline attack rate, in a 3:2:2:2 ratio (placebo, lanadelumab 150 mg every 4 weeks [q4wks], lanadelumab 300 mg every 4 weeks [q4wks], or lanadelumab 300 mg every 2 weeks [q2wks] by SC injection) for the 26-week treatment period.
Maltese: jew II. L-individwi kienu randomised fi grupp wieħed minn 4 gruppi ta' trattament parallel, stratifikati skont ir-rata ta' attakk fil-linja bażi, fi proporzjon ta' 3:2:2:2 (plaċebo, lanadelumab 150 mg kull 4 ġimgħat [q4wks], lanadelumab 300 mg kull 4 ġimgħat [q4wks], jew lanadelumab 300 mg kull ġimagħtejn [q2wks] b'injezzjoni SC) għall-perjodu ta' trattament ta' 26 ġimgħa.
English: Hypersensitivity reactions have been observed.
Maltese: Ġew osservati reazzjonijiet ta' sensittività eċċessiva.
English: Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.
Maltese: Minn dawn l-ISRs, 97% kienu ta' intensità ħafifa, 90% għaddew fi żmien jum wieħed wara l-bidu b'tul medjan ta' 6 minuti.
English: Increased plasma kallikrein activity leads to angioedema attacks in patients with HAE through the proteolysis of high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin.
Maltese: Żieda fl-attività ta' kallikrein fil-plażma twassal għal attakki ta' anġjoedima f'pazjenti b'HAE permezz ta' proteolisi ta' kininogen ta' piż molekulari għoli (HMWK - high-molecular-weight-kininogen) biex tiġġenera
English: TAKHZYRO total
Maltese: Plaċebo TAKHZYRO totali
English: In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: TAKHZYRO 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE TAKHZYRO 300 mg
English: A total of 212 adult and adolescent subjects with symptomatic type I or II HAE received at least one dose of lanadelumab in this study, including 109 subjects who entered as rollover subjects from the HELP study and 103 new or non-rollover subjects (including 19 subjects from Phase1b study) who had an historical baseline attack rate of ≥1 attack per 12 weeks Subjects were allowed to initiate self-administration after receiving the first 2 doses from a health care professional in clinic and completing appropriate training.
Maltese: Total ta' 212-il individwu adult u adolexxent b'HAE sintomatika tat-tip I jew II irċevew mill-inqas doża waħda ta' lanadelumab f'dan l-istudju, li kien jinkludi 109 individwi li daħlu bħala individwi ta' estensjoni mill-istudju HELP u 103 individwi ġodda jew mhux ta' estensjoni (inkluż 19-il individwu mill-istudju tal-Fażi 1b) li kellhom rata ta' attakki storika fil-linja bażi ta' ≥ attakk wieħed kull 12-il ġimgħa.
English: System organ class
Maltese: Klassifika tas-sistemi u tal-organi
English: • Empty 3 ml syringe
Maltese: • Siringa ta' 3 ml vojta
English: Long-term safety and efficacy of TAKHZYRO for prophylaxis to prevent HAE attacks was evaluated in an open-label HELP study extension.
Maltese: Is-sigurtà u l-effikaċja fit-tul ta' TAKHZYRO għal profilassi biex jiġu evitati attakki ta' HAE ġew evalwati f'estensjoni open-label tal-istudju HELP.
English: All TAKHZYRO treatment arms produced statistically significant reductions in the mean HAE attack rate compared to placebo across all primary and secondary endpoints in the Intent-to-Treat population (ITT) (Table 2).
Maltese: Il-gruppi kollha ta' trattament b'TAKHZYRO pproduċew tnaqqis statistikament sinifikanti fir-rata medja ta' attakki ta' HAE meta mqabbla ma' plaċebo fil-punti aħħarin primarji u sekondarji kollha filpopolazzjoni b'Intenzjoni li Tiġi Ttrattata (ITT - Intent-to-Treat) (Tabella 2).
English: Primary endpoint - Number of HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Maltese: Punt aħħari primarju - Numru ta' attakki ta' HAE minn Jum 0 sa 182 Rata Medja LS ta' attakki fix-xahar (CI ta' 95%)
English: TAKHZYRO 300 mg solution for injection lanadelumab
Maltese: TAKHZYRO 300 mg soluzzjoni għall-injezzjoni lanadelumab
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC05
Maltese: Sustanzi ematoloġiċi oħra, mediċini użati f'anġjoedima ereditarja, Kodiċi ATC:
English: How to store TAKHZYRO 6.
Maltese: Kif taħżen TAKHZYRO 6.
English: The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system.
Maltese: Ir-reaġenti wżati fit-test tal-laboratorju ta' aPTT jibdew koagulazzjoni intrinsika permezz tal-attivazzjoni ta' kallikrein fil-plażma fis-sistema ta' kuntatt.
English: • 27G x ½ inch (0.4 x 13 mm) injection needle 6.6 Special precautions for disposal and other handling
Maltese: • Labra tal-injezzjoni ta' 27G x ½ pulzier (0.4 x 13 mm) 6.6 Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor Lanadelumab huwa pprovdut f'kunjetti għall-użu ta' darba.
English: Skin and subcutaneous tissue disorders Rash maculo-papular
Maltese: Raxx makulo-papulari
English: Step 2: Attach blunt tip vial access needle to syringe a) Screw the 18 gauge blunt tip vial access needle to the 3 ml syringe.
Maltese: Pass 3. Ittrasferixxi TAKHZYRO fis-siringa u ibdel għal-labra tal-injezzjoni bil-ponta a) Daħħal il-labra f'nofs it-tapp tal-lastku.