FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the Committee adopted by majority a positive opinion on 6 March 2013 recommending the granting of a marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Maltese: Għaldaqstant il-Kumitat adotta b'maġġoranza opinjoni pożittiva fis-6 ta' Marzu 2013 u rrakkomanda l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq għal Florgane 300 mg/ml sospensjoni għall-injezzjoni għall-frat u l-ħnieżer u ismijiet assoċjati.
English: Day 60 of the CMD(v) procedure was on 19 April 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Is-60 jum tal-proċedura tasCMD(v) kien fid-19 ta' April 2012, u peress li l-Istati Membri inkwistjoni ma rnexxilhomx jilħqu qbil rigward il-prodott, il-proċedura ġiet riferuta lis-CVMP.
English: It is available as tablets (300 mg/150 mg/300 mg).
Maltese: Jiġi bħala pilloli (300 mg/150 mg/300 mg).
English: This summary was last updated in 04-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 04-2016.
English: The full EPAR for Trizivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Trizivir abacavir, lamivudine and zidovudine
Maltese: Trizivir abakavir, lamivudina u żidovudina
English: This document is a summary of the European Public Assessment Report (EPAR) for Trizivir.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR) għal Trizivir.
English: All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: It-tliet sustanzi attivi kollha fi Trizivir, l-abakavir, il-lamivudina u ż-żidovudina huma inibituri nukleosidiċi tat-transkrittażi inversa (nucleoside reverse transcriptase inhibitors, NRTIs).
English: The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Maltese: Ir-riskju ta' ipersensittività huwa ogħla fil-pazjenti li għandhom il-ġene HLA-B (tip 5701).
English: Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Trizivir jintuża fil-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana (HIV), il-virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy
Maltese: Fost is-sintomi kważi dejjem hemm deni u raxx, iżda huma komuni ħafna wkoll nawżea, remettar, dijarea, uġigħ addominali (uġigħ fl-istonku), uġigħ ta' ras, sinjali ta' ħsara tal-fwied fid-demm, mijalġija (uġigħ fil-muskoli), dispnea (diffikultà biex tieħu n-nifs), sogħla, letarġija (nuqqas ta' enerġija) u telqa(ma tħossokx f'siktek).
English: What is Trizivir?
Maltese: X'inhu Trizivir?
English: All three active substances have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid-1980s.
Maltese: It-tliet sustanzi attivi kollha ilhom disponibbli fl-Unjoni Ewropea (UE) għal għadd ta' snin: l-abakavir ilu awtorizzat bħala Ziagen sa mill-1999, il-lamivudina ilha awtorizzata bħala Epivir sa mill-1996, u żżidovudina ilha disponibbli fl-UE sa minn nofs it-tmeninijiet.
English: No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet.
Maltese: Ma twettaq l-ebda studju kliniku speċifiku biex jivvaluta s-sigurtà u l-effikaċja tal-pillola kombinata.
English: What is the risk associated with Trizivir?
Maltese: X'inhu r-riskju assoċjat ma' Trizivir?
English: Why has Trizivir been approved?
Maltese: Għaliex ġie approvat Trizivir?
English: In addition, the company that markets Trizivir provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Trizivir fis-suq tipprovdi materjali edukattivi għat-tobba dwar reazzjonijiet ta' ipersensittività bil-mediċina, inkluż il-ħtieġa li l-pazjenti jiġu eżaminati għall-ġene HLAB (tip 5701) u biex ifakkru lill-pazjenti sabiex jikkuntattjaw lit-tabib tagħhom minnufih jekk jiżviluppaw sintomi li juru ipersensittività.
English: The European Commission granted a marketing authorisation valid throughout the EU for Trizivir on 28 December 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Trizivir valida fl-Unjoni Ewropea kollha fit-28 ta' Diċembru 2000.
English: The combination tablet was absorbed in the body in the same way as the separate tablets.
Maltese: Il-pillola kombinata ġiet assorbita fil-ġisem bl-istess mod kif jiġu assorbiti l-pilloli separati.
English: The recommended dose of Trizivir is one tablet twice a day.
Maltese: Id-doża rakkomandata ta' Trizivir hija pillola darbtejn kuljum.
English: Trizivir is a medicine that contains three active substances: abacavir, lamivudine and zidovudine.
Maltese: Trizivir huwa mediċina li fiha tliet sustanzi attivi: l-abakavir, il-lamivudina u ż-żidovudina.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir so they should not take Trizivir.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Trizivir jintuża bl-aktar mod sigur possibbli.
English: In patients with high levels of HIV in the blood (above 100,000 copies/ml), the choice of treatment requires special consideration.
Maltese: F'pazjenti b'livelli għoljin ta' HIV fid-demm (‘il fuq minn 100,000 kopja/ml), l-għażla tal-kura teħtieġ konsiderazzjoni speċjali.
English: Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Maltese: Qabel ma tinbeda l-kura bl-abakavir, il-pazjenti kollha għandu jkollhom test sabiex ikunu jafu jekk għandhomx il-ġene bl-isem ‘HLA-B (tip 5701)'.
English: They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: Kollha kemm huma jaħdmu b'mod simili billi jimblukkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li tħalli l-virus jinfetta ċ-ċelloli u jiġġenera aktar virusis.
English: It is used to replace treatment with the three active substances (abacavir, lamivudine and zidovudine) taken separately at doses similar to those in Trizivir.
Maltese: Jintuża biex jissostitwixxi l-kura bit-tliet sustanzi attivi (l-abakavir, il-lamivudina u ż-żidovudina) li jittieħdu separatament f'dożi simili għal dawk fi Trizivir.
English: Trizivir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Trizivir ma jfejjaqx infezzjoni mill-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: How is Trizivir used?
Maltese: Għal xiex jintuża Trizivir?
English: If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately.
Maltese: Jekk il-pazjenti jeħtieġu li jieqfu jieħdu labakavir, il-lamivudina jew iż-żidovudina, jew li jieħdu dożi differenti minħabba problemi fil-kliewi, filfwied jew fid-demm, jeħtieġu li jieħdu mediċini li jkun fihom l-abakavir, il-lamivudina jew iż-żidovudina separatament.
English: Immediate Packaging
Maltese: (pakkett multiplu) +
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1337/001
Maltese: EU/1/18/1337/001
English: • mild to moderate depressive episodes (St. John´s wort (Hypericum perforatum))
Maltese: • l-episodji ta' dipressjoni ħfief sa moderati (St. John´s wort (Hypericum perforatum))
English: Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
Maltese: Lactose monohydrate Colloidal anhydrous silica Crospovidone tip A Saccharin sodium dihydrate Sodium stearyl fumarate
English: Information about lactose and sodium
Maltese: Informazzjoni dwar lactose u sodium
English: Contains lactose monohydrate 1,691.8 mg per sachet.
Maltese: Fih lactose monohydrate 1,691.8 mg kull qartas.
English: Reconstituted suspension:
Maltese: Sospensjoni rikostitwita:
English: • cystic fibrosis (lumacaftor)
Maltese: • il-fibrożi ċistika (lumacaftor)
English: MedDRA organ class
Maltese: Sistema tal-klassifika talorgani MedDRA
English: • The active substance is macimorelin.
Maltese: • Is-sustanza attiva hi macimorelin.
English: Reconstituted suspension
Maltese: Sospensjoni rikostitwita
English: Macimorelin is moderately bound to plasma proteins.
Maltese: Macimorelin huwa moderatament marbut mal-proteini tal-plażma.
English: Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours.
Maltese: Macimorelin ġie eliminat b'half-life terminali medja (T1/2) ta' 4.1 sigħat.
English: Macimorelin is metabolised mainly by CYP3A4 in vitro.
Maltese: Macimorelin jiġi metabolizzat prinċipalment mill-CYP3A4 in vitro.
English: You have to drink the complete test dose within 30 seconds.
Maltese: Trid tixrob id-doża tat-test kollha fi 30 sekonda.
English: Repeatability was 97%.
Maltese: Ir-ripetibbiltà kienet ta' 97%.
English: • cancer (dabrafenib, enzalutamide)
Maltese: • il-kanċer (dabrafenib, enzalutamide)
English: • seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
Maltese: • aċċessjonijiet/epilessija (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine,
English: • medicines to treat psychosis (such as chlorpromazine, haloperidol)
Maltese: • mediċini kontra l-psikożi (bħal chlorpromazine, haloperidol)
English: White to off-white granules.
Maltese: Granuli ta' kulur abjad jew off-white.
English: Dysgeusia (bitter/metallic taste)
Maltese: Dysgeusia (togħma qarsa/metallika)
English: Sinus bradycardia
Maltese: Bradikardija tassinus
English: Both co-primary endpoints as pre-defined in Study 052 (lower limit of the 95% CI for negative agreement ≥ 75%, lower limit of the 95% CI for positive agreement ≥ 70%) are met when using an ITT cut-off point of 3.0 ng/mL and the pre-defined cut-off point for the MAC of 2.8 ng/mL.
Maltese: Iż-żewġ punti aħħarin ko-primarji kif predefiniti fl-Istudju 052 (limitu baxx tas-CI ta' 95% għal ftehim negattiv ≥ 75%, limitu aktar baxx tas-CI ta' 95% għal ftehim pożittiv ≥ 70%) huma ssodisfati meta tintuża linja tal-qtugħ tal-ITT ta' 3.0 ng/mL u linja tal-qtugħ predefinita għall-MAC ta' 2.8 ng/mL.
English: At the clinically relevant concentration of 0.1 µM (clinical Cmax = 11.2 ng/ml = approx. 0.02 µM), the unbound fraction of macimorelin in human plasma is
Maltese: Fil konċentrazzjoni klinikament relevanti ta' 0.1 µM (Cmax klinika = 11.2 ng/ml = madwar 0.02 µM), ilfrazzjoni mhux marbuta ta' macimorelin tal-plażma fil-bniedem hija ta' 22%.
English: D-60314 Frankfurt am Main Germany
Maltese: D-60314 Frankfurt am Main
English: Administration of a CYP3A4 inducer (such as carbamazepine, dabrafenib, efavirenz, enzalutamide, eslicarbazepine, fosphenytoin, lumacaftor, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, pitolisant, primidone, rifabutin, rifampicin and St John's wort (Hypericum perforatum)) may reduce the plasma macimorelin concentrations and may affect the diagnostic performance of the test and therefore should be avoided.
Maltese: eslicarbazepine, fosphenytoin, lumacaftor, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, pitolisant, primidone, rifabutin, rifampicin u St John's wort (Hypericum perforatum)) jaf inaqqas il-konċentrazzjonijiet ta' macimorelin fil-plażma u jaf jaffettwa l-prestazzjoni dijanjostika tat-test u għalhekk għandu jkun evitat.
English: Macimorelin was absorbed rapidly and the maximum plasma macimorelin concentrations (Cmax) were observed approximately 30 minutes to 1 hour and 10 minutes after oral administration of 0.5 mg/kg macimorelin after fasting for at least 8 hours.
Maltese: Macimorelin ġie assorbit rapidament u l-konċentrazzjonijiet massimi ta' macimorelin fil-plażma (Cmax) ġew osservati bejn wieħed u ieħor 30 minuta sa siegħa u 10 minuti wara amministrazzjoni orali ta' 0.5 mg/kg ta' macimorelin wara sawm għal mill-inqas tmien sigħat.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should take this medicinal product only if the expected benefit of the test clearly outweighs the potential risk associated with an intake of maximum 1,691.8 mg lactose per sachet.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall galactose, ta' nuqqas totali ta' lactase jew tal-assorbiment ħażin tal- glucose-galactose, għandhom jieħdu dan il-prodott mediċinali biss jekk il-benefiċċju mistenni tat-test jisboq biċ-ċar ir-riskju potenzjali assoċjat mat-teħid ta' massimu ta' 1,691.8 mg ta' lactose għal kull qartas.
English: The most common adverse reactions associated with Macimorelin Aeterna Zentaris reported in Study 052 (see section 5.1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%).
Maltese: L-aktar reazzjonijiet avversi komuni assoċjati ma' Macimorelin Aeterna Zentaris li ġew irrapportati flIstudju 052 (ara s-sezzjoni 5.1), f'154 pazjent kienu dysgeusia (5%), uġigħ ta' ras, għeja, dardir (3% kull wieħed), sturdament (2%), kif ukoll uġigħ addominali, dijarea, sħana, kesħa, ġuħ, palpitazzjonijiet, bradikardija tas-sinus, ngħas, għatx, rogħda, u vertiġini (1% kull wieħed).
English: The median age was 41 years (range: 18 - 66 years) and body mass index 27.5 kg/m2 (range: 16 - 40 kg/m2).
Maltese: (medda: bejn it-18 u s-66 sena) u indiċi tal-massa tal-ġisem ta' 27.5 kg/m2 (medda: 16 - 40 kg/m2).
English: ECG T wave abnormal
Maltese: T talECG anormali
English: Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin.
Maltese: ġew bejn wieħed u ieħor osservati 45 u 60 minuta wara li ngħata macimorelin.
English: Adverse reactions reported in Study 052 are listed below by MedDRA body system organ class and by frequency: 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); not known (cannot be estimated from available data).
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), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: • sleep disorder (modafinil, pitolisant)
Maltese: • disturbi fl-irqad (modafinil, pitolisant)
English: In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1).
Maltese: QTc > 500 ms, għandu jiġi applikat monitoraġġ tal-ECG (ara s-sezzjoni 4.4 u 5.1).
English: Interpretation of macimorelin test results
Maltese: Interpretazzjoni tar-riżultati tat-test ta' macimorelin
English: PC: {number} SN: {number} NN: {number}
Maltese: M'hemmx dejta dwar l-użu ta' macimorelin f'nisa tqal.
English: Negative and positive agreement between MAC and the ITT in subjects with intermediate or low risk (Groups B and C) were 93% and 61% with lower 95% confidence interval bounds 80% and 43%, respectively.
Maltese: Ftehim negattiv u pożittiv bejn il-MAC u l-ITT f'individwi b'riskju intermedju jew baxx (Gruppi B u Ċ) kien 93% u 61% b'limiti ta' intervall ta' fiduċja ta' 95% iktar baxx, 80% u 43% rispettivament.
English: Each sachet contains 1,817 mg granules.
Maltese: Kull qartas fih 1,817 mg granuli.
English: • medicines to treat infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
Maltese: • mediċini biex tikkura infezzjonijiet (antibijotiċi bħal erythromycin, clarithromycin, moxifloxacin)
English: crospovidone type A, saccharin sodium dihydrate and sodium stearyl fumarate (see section 2 under ‘Macimorelin Aeterna Zentaris contains sodium').
Maltese: Zentaris fih il-lactose"), colloidal anhydrous silica, crospovidone type A, saccharin sodium dihydrate u sodium stearyl fumarate (ara sezzjoni 2 taħt "Macimorelin Aeterna Zentaris fih is sodium").
English: Step 5
Maltese: Pass 5
English: Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1).
Maltese: Macimorelin Aeterna Zentaris huwa indikat għad-dijanjożi ta' defiċjenza fl-ormoni li jistimolaw it tkabbir (GHD, growth hormone deficiency) fl-adulti (ara s-sezzjoni 5.1).
English: A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively.
Maltese: AUC ta' macimorelin b'0.42 u b'0.5 drabi, rispettivament.
English: The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2.
Maltese: Is-sigurtà u l-prestazzjoni dijanjostika ta' macimorelin ma ġewx determinati s'issa għal pazjenti b'BMI > 40 kg/m2.
English: • Fasting - you must not eat for at least 8 hours before the test, and during the test.
Maltese: • Sawm - ma għandekx tiekol għal mill-inqas 8 sigħat qabel it-test, u waqt it-test.
English: The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years.
Maltese: Il-farmakodinamika ta' macimorelin ma ġietx evalwata biżżejjed fil-popolazzjoni anzjana > 65 sena.
English: • a bitter or metallic taste (dysgeusia)
Maltese: • togħma qarsa jew metallika (dysgeusia)
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1).
Maltese: madwar 11-il millisekonda fl-intervall tal-QT (QTc) (ara s-sezzjoni 5.1).
English: In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
Maltese: F'pazjenti ta' bejn it-18 u l-25 sena, il-prestazzjoni dijanjostika tal-MAC u tal-ITT kienu komparabbli.
English: Medicinal products with a potential to induce torsades de pointes
Maltese: Prodotti mediċinali li għandhom il-potenzjal li jinduċu torsades de pointes
English: GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK).
Maltese: Il-livelli tal-GH ġew stabbiliti ċentralment bl-assaġġ IDS-iSYS (Immunodiagnostic Systems Ltd., irRenju Unit).
English: • infections (antibiotics such as rifabutin, rifampicin)
Maltese: • infezzjonijiet (antibijotiċi bħal rifabutin, rifampicin)
English: Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively.
Maltese: L-estimi tal-punti għas-sensittività u l ispeċifiċità kienu 87% u 96% f'individwi ta' Grupp A mhux imqabbla, rispettivament.
English: 1 mL of the reconstituted suspension contains 500 micrograms macimorelin.
Maltese: 1 mL ta' sospensjoni rikostitwita fiha 500 mikrogramma ta' macimorelin.
English: Step 4
Maltese: Pass 4
English: GH stimulation
Maltese: Stimulazzjoni tal-GH
English: The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study of a supra-therapeutic dose of macimorelin (2 mg/kg) and in a single-ascending dose study, which included three dose levels of macimorelin (0.5 mg/kg, 1 mg/kg and 2 mg/kg).
Maltese: L-effetti ta' macimorelin fuq il-parametri tal-ECG ġew investigati fi studju QT Approfondit iddedikat ta' doża supraterapewtika ta' macimorelin (2 mg/kg) u fi studju ta' doża waħda axxendenti, li inkluda tliet livelli ta' dożi ta' macimorelin (0.5 mg/kg, 1 mg/kg u 2 mg/kg). Macimorelin jikkawża żieda ta'
English: The medicine contains an active substance called macimorelin.
Maltese: Il-mediċina fiha sustanza attiva msejħa macimorelin.
English: Clinical studies have established that a maximally stimulated serum GH level of less than 2.8 ng/mL (at the 45, 60 and 90 minutes timepoints) following macimorelin administration confirms a diagnosis of adult growth hormone deficiency.
Maltese: L-istudji kliniċi stabbilixxew li livell ta' GH ta' serum stimulat massimalment ta' inqas minn 2.8 ng/mL (waqt il-punti ta' tmiem ta' 45, 60 u 90 minuta) wara li jingħata macimorelin jikkonferma dijanjożi ta' nuqqas ta' ormoni li jistimolaw it-tkabbir fl-adulti.
English: One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Qartas wieħed tal-LDPE/Alu/LDPE/karta li fih 1,817 mg granuli mpoġġi f'kaxxa tal-kartun.
English: • type 2 diabetes (pioglitazone)
Maltese: • id-dijabete ta' tip 2 (pioglitazone)
English: Macimorelin Aeterna Zentaris can cause changes in the ECG (electrocardiogram) including QT prolongation that are associated with an increased risk for arrhythmias.
Maltese: Macimorelin Aeterna Zentaris jista' jikkawża bidliet fl-ECG (elettrokardjogramma) inkluż titwil tal-QT li huwa assoċjat ma' żieda fir-riskju għal arritmiji.
English: Step 3
Maltese: Pass 3
English: The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study that investigated in a 3-way cross-over design with 60 healthy subjects the effects of a supra-therapeutic dose of macimorelin (2 mg/kg, i.e., 4 times the recommended dosage) in comparison with placebo and with moxifloxacin.
Maltese: L-effetti ta' macimorelin fuq parametri tal-ECG ġew investigati fi studju QT Approfondit iddedikat li investiga f'disinn ta' 3-way cross-over b'60 individwu b'saħħtu, l-effetti ta' doża supra-terapewtika ta' macimorelin (2 mg/kg, jiġifieri erba' darbiet aktar mid-dożaġġ rrakkomdatat) meta mqabbel ma' plaċebo u moxifloxacin.
English: Repeatability was tested in a subset of 34 subjects who underwent two MAC tests.
Maltese: Ir-ripetibilità ġiet ittestjata f'subsett ta' 34 individwu li għamlu żewġ testijiet tal-MAC.
English: • The other ingredients are: lactose monohydrate (see section 2 under ‘Macimorelin Aeterna Zentaris contains lactose'), colloidal anhydrous silica,
Maltese: • L-ingredjenti l-oħra huma: lactose monohydrate (ara sezzjoni 2 taħt "Macimorelin Aeterna
English: Aeterna Zentaris GmbH Weismüllerstrasse 50 D-60314 Frankfurt am Main Germany
Maltese: Aeterna Zentaris GmbH D-60314 Frankfurt am Main, Il-Ġermanja
English: Step 7
Maltese: Pass 7
English: 38 (27%) in Group A, 37 (26%) in Group B, 40 (29%) in Group C and 25 (18%) in Group D. One out of 154 MAC tests (0.6%) performed failed due to a technical error and 27 out of 157 ITTs (17.2%) performed failed because induction of severe hypoglycemia (i.e., the stimulus) could not be achieved.
Maltese: (0.6%) li saru falla minħabba żball tekniku u 27 minn 157 ITTs (17.2%) li saru fallew minħabba li ma inkisbitx induzzjoni ta' ipogliċemija severa (jiġifieri l-istimulu).
English: Only limited pharmacokinetic data are available in the elderly.
Maltese: Hija biss disponibbli dejta farmakokinetika limitata fl-anzjani.
English: Marketing Authorisation Holder and Manufacturer Aeterna Zentaris GmbH
Maltese: Aeterna Zentaris GmbH
English: Step 6
Maltese: Pass 6