FrancophonIA/ELRC3.0 huggingface dataset:
English: This study showed a mean baseline- and placebo-adjusted change (upper single-sided 95% confidence interval) in QTcF of 9.6 ms (11.4 ms) at 4 h post-dose (see also section 4.4), which occurred after the mean maximum macimorelin plasma concentration (0.5 h).
Maltese: Dan l-istudju wera bidla fil-linja bażi medja u aġġustata għall-plaċebo (intervall ta' fiduċja ta' 95% min-naħa waħda ta' fuq) fil-QTcF ta' 9.6 millisekondi (11.4 millisekondi) f'4 sigħat wara li tkun ingħatat id-doża (ara wkoll is-sezzjoni 4.4), li seħħet wara l-konċentrazzjoni massima medja ta' macimorelin fil-plażma (0.5 h).
English: Items needed: Macimorelin Aeterna Zentaris sachet, tap water in decanter, graduated glass or transparent plastic container, stirring device, 50 mL graduated syringe without needle, drinking glass
Maltese: Qartas ta' Macimorelin Aeterna Zentaris, ilma tal-vit f'dekanter, tazza jew kontenitur tal-plastik trasparenti gradwari, oġġett biex tħawwad, siringa bla labra ta' 50 mL gradwata, tazza għax-xorb
English: • Physical exercise - avoid strenuous physical activity 24 hours before the test.
Maltese: • L-eżerċizzju fiżiku - evita eżerċizzju fiżiku strapazzanti 24 siegħa qabel it-test.
English: For both the ITT and the MAC test, serum concentrations of GH were measured at 30, 45, 60 and 90 minutes after administration.
Maltese: Kemm għat-test tal-ITT kif ukoll għal dak tal-MAC, il-konċentrazzjonijiet fis-serum tal-GH tkejlu wara 30, 45, 60 u 90 minuta wara li ngħatat id-doża.
English: Each sachet contains 60 mg macimorelin (as acetate).
Maltese: Kull qartas fih 60 mg macimorelin (bħala aċetat).
English: Point estimates for sensitivity ranged from 0.87 to 0.90 for the MAC and from 0.97 to 1.0 for the ITT, depending on the inclusion or exclusion of data from not matched Group A subjects, respectively.
Maltese: L-estimi ta' punt għal sensittività varja bejn 0.87 u 0.90 għall-MAC u 0.97 u 1.0 għall-eżami ITT,
English: CYP3A4 is the major enzyme to metabolize macimorelin.
Maltese: Is-CYP3A4 hija l-enżima ewlenija li timmetabolizza macimorelin.
English: A similar increase in the QTcF interval was also observed in a single-ascending dose study, which included three dose levels (0.5 mg/kg, 1 mg/kg and 2 mg/kg (2 times and 4 times the recommended dosage, respectively)).
Maltese: Żieda simili fl-intervall tal-QTcF ġiet osservata wkoll fi studju ta' doża waħda li togħla, li inkludiet tliet livelli ta' dożi (0.5 mg/kg, 1 mg/kg u 2 mg/kg
English: The estimates for negative and positive agreement between MAC and the ITT in the overall study population were 94% and 74% with lower 95% confidence interval bounds 85% and 63%, respectively.
Maltese: L-estimi għal ftehim negattiv u pożittiv bejn il-MAC u l-ITT fil-popolazzjoni tal-istudju ġenerali kienu ta' 94% u 74% b'limiti l-baxxi ta' intervall ta' fiduċja ta' 95%, 85% u 63% rispettivament.
English: Drug-drug interaction studies with CYP3A4/P-gp-inhibitors have not been conducted.
Maltese: Studji ta' interazzjoni ta' mediċina ma' oħra b'inibituri CYP3A4/P-gp għandhom ma sarux.
English: Potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors
Maltese: Potenzjal għal żieda fil-bijodisponibilità orali u fil-konċentrazzjoni ta' macimorelin fil-plażma bl-użu ta' inibituri CYP3A4/P-gp b'saħħithom
English: Co-administration of macimorelin with medicinal products with a potential to induce torsades de pointes (antipsychotic medicinal products e.g. chlorpromazine, haloperidol, antibiotics (e.g., moxifloxacin, erythromycin, clarithromycin), anti-arrhythmics Class Ia (e.g. quinidine), and Class III (e.g. amiodarone, procainamide, sotalol) or any other medicinal products that may induce torsades de pointes) should be avoided (see section 4.4).
Maltese: Għandu jiġi evitat li macimorelin jingħata ma' prodotti mediċinali li għandhom il-potenzjal li jinduċu torsades de pointes (prodotti mediċinali antipsikotiċi eż. chlorpromazine, haloperidol, antibijotiċi (eż.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Maltese: Wara r-rikostituzzjoni: 500 mikrogramm macimorelin/mL
English: Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06
Maltese: Aġenti dijanjostiċi, Testijiet għall-funzjoni pitwitarja, kodiċi
English: Four groups of individuals were evaluated: three groups of adult patients with different pre-test probability of growth hormone deficiency (Group A (high likelihood), Group B (intermediate likelihood), Group C (low likelihood) and healthy control subjects (Group D)).
Maltese: Ġew evalwati erba' gruppi ta' individwi: tliet gruppi ta' pazjenti adulti bi probabbiltà ta' qabel it test differenti ta' nuqqas ta' ormon li jistimola t-tkabbir (Grupp A (li kellhom probabbiltà kbira), Grupp
English: Potential for false positive test results with use of strong CYP3A4 inducers
Maltese: Potenzjal għal riżultati ta' testijiet pożittivi falzi, b'użu ta' indutturi CYP3A4 b'saħħithom.
English: Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM.
Maltese: It-twaħħil tal-proteini tal-plażma jonqos hemm kif jiżdiedu l-konċentrazzjonijiet minn 78% f'0.1 µM sa 62% f'10 µM.
English: In a diagnostic study comparing macimorelin with the insulin tolerance test (ITT) stimulated GH concentrations after macimorelin were on average 1.4 fold higher than in the ITT.
Maltese: Fi studju dijanjostiku li jqabbel macimorelin mat-test ta' tolleranza tal-insulina (ITT, insulin tolerance test), il-konċentrazzjonijiet tal-GH stimulati kienu bħala medja 1.4 drabi ogħla mill-ITT.
English: Studies to detect macimorelin metabolites did not identify any metabolites.
Maltese: L-istudji biex jiġu identifikati lmetaboliti ta' macimorelin ma identifikaw l-ebda metabolit.
English: A sufficient washout time of five elimination half-lives of the CYP3A4 inducer prior to administration of the test is recommended (see section 4.2 and section 4.4).
Maltese: Huwa rrakkomdandat żmien ta' washout suffiċjenti ta' ħames half-lives ta' eliminazzjoni tal-induttur CYP3A4 qabel ma jsir it-test (ara s-sezzjoni 4.2 u ssezzjoni 4.4).
English: One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin.
Maltese: Mija u sebgħa u ħamsin (157) individwu għamlu minn tal-anqas wieħed miż-żewġ eżamijiet f'dan listudju, 59% kienu rġiel, 41% nisa u 86% kienu ta' oriġini bajda.
English: The diagnostic efficacy of Macimorelin Aeterna Zentaris was established in a randomized, open-label, single dose, cross-over study (AEZS-130-052) comparing the level of agreement between the macimorelin test (MAC) results and insulin tolerance test (ITT) results.
Maltese: Effikaċja klinika u sigurtà L-effikaċja dijanostika ta' Macimorelin Aeterna Zentaris ġiet stabbilita fi studju kawżali, bit-tikketta mikxufa, ta' doża waħda, cross-over (AEZS-130-052) li qabbel il-livell ta' ftehim bejn ir-riżultati tattest ta' macimorelin (MAC) u r-riżultati tat-test tat-tolleranza għall-insulina (ITT, insulin tolerance test).
English: Based on current understanding, this is unlikely to decrease the specificity of the test.
Maltese: Skont fehim attwali, dan huwa improbabbli li jnaqqas l-ispeċifiċità tat-test.
English: During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions.
Maltese: Waqt żvilupp kliniku, ġew osservati żewġ anormalitajiet temporanji tal-ECG f'suġġett wieħed tat-test u ġew irrapportati bħala reazzjonijiet avversi possibilment serji.
English: • Medicinal products that may blunt the growth hormone response to macimorelin (such as muscarinic antagonists: atropine, anti-thyroid medicinal products: propylthiouracil and growth hormone medicinal products).
Maltese: • Il-prodotti mediċinali li jistgħu jrażżnu r-rispons tal-ormon li jistimola t-tkabbir għal macimorelin (bħal antagonisti muskariniċi: atropina, prodotti mediċinali kontra t-tirojde: propylthiouracil u prodotti mediċinali tal-ormoni li jistimolaw it-tkabbir).
English: Agreement between the result of the first test and the second test was observed in 31 cases (91.2%).
Maltese: Ftehim bejn irriżultat tal-ewwel test u t-tieni test ġie osservat f'31 każ (91.2%).
English: How Macimorelin Aeterna Zentaris is given
Maltese: Mediċini oħra u Macimorelin Aeterna Zentaris
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: For both GHSTs, the estimated specificity was 0.96, irrespective of the in/exclusion data from not matched Group A subjects.
Maltese: Għaż-żewġ GHSTs, l-ispeċifiċità stmata kienet 0.96, irrispettivament millinklużjoni/esklużjoni tad-dejta minn suġġetti tal-Grupp A mhux imqabbla.
English: Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy
Maltese: Pazjenti bil-marda ta' Cushing jew li qed isegwu terapija tal-glukokortikojdi supra-fiżjoloġika
English: • that could have a direct influence on growth hormone secretion by the pituitary gland: such as somatostatin, insulin, glucocorticoids, acetylsalicylic acid,
Maltese: • li jista' jkollhom influwenza diretta fuq is-sekrezzjoni tal-ormoni li jistimolaw it-tkabbir mill glandola pitwitarja: bħal somatostatin, insulina, glukokortikojdi, acetylsalicylic acid, indometacin
English: In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point.
Maltese: Fil-grupp ta' età ta' bejn is-60 u l-65 sena, id-dejta limitata disponibbli ma tindikax il-bżonn li jkun hemm punt ta' linja tal-qtugħ separata.
English: The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight.
Maltese: Id-doża rrakkomandata hija ta' 0.5 mg ta' Macimorelin Aeterna Zentaris għal kull kg ta' piż tal-ġisem.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aeterna Zentaris GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Aeterna Zentaris GmbH
English: In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
Maltese: F'pazjenti b'BMI għoli sa 40 kg/m2, il-prestazzjoni dijanjostika tal-MAC u tal-ITT kienu komparabbli.
English: Macimorelin Aeterna Zentaris contains sodium This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say it is essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) għal kull qartas, jiġifieri hija essenzjalment "mingħajr sodium".
English: • lower than normal heart rate (sinus bradycardia)
Maltese: • palpitazzjonijiet • taħbit tal-qalb anqas minn normali (bradikardija tas-sinus)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107ċ(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension macimorelin
Maltese: TAL-PRODOTT MEDIĊINALI Macimorelin Aeterna Zentaris 60 mg granuli għal sospensjoni orali macimorelin
English: An exploratory analysis was conducted on the performance of the MAC based on an ITT cut-off point of 3.0 ng/mL.
Maltese: Analiżi post-hoc b'linja tal-qtugħ ta' 3.0 ng/mL għat-test ITT Saret analiżi esploratorja dwar il-prestazzjoni tal-MAC abbażi tal-linja tal-qtugħ tal-ITT ta' 3.0 ng/mL.
English: Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended.
Maltese: Huwa rrakkomandat perjodu ta' washout suffiċjenti (ħames half-lives ta' eliminazzjoni) ta' prodotti mediċinali qabel ma jingħata macimorelin.
English: A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Maltese: Potenzjal għal żieda fil-bijodisponibilità orali u fil-konċentrazzjoni ta' macimorelin fil-plażma bl-użu ta' inibituri CYP3A4/P-gp b'saħħithom ma jistgħux jiġu esklużi.
English: Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus.
Maltese: Macimorelin jaġixxi downstream millipotalamu u r-rilaxx stimulat ta' macimorelin ta' riżervi tal-GH maħżuna mill-pitwitarja anterjuri jista' jipproduċi riżultat negattiv falz kmieni meta l-leżjoni tkun tinvolvi l-ipotalamu.
English: In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable.
Maltese: F'pazjenti ta' età sa 60 sena, il-prestazzjoni dijanjostika tal-MAC u tal-ITT kienu komparabbli.
English: Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Maltese: Macimorelin Aeterna Zentaris 60 mg granuli għal sospensjoni orali f'qartas macimorelin
English: Exogenous GH or medicinal products directly affecting the pituitary gland could influence the somatotropic function of the pituitary gland and lead to unreliable GH stimulation results (see also section 4.2 and section 4.5).
Maltese: Dawn is-sustanzi jistgħu jwasslu għal riżultati ta' stimulazzjoni mhux affidabbli tal-GH (ara wkoll is-sezzjoni 4.4 u 4.5).
English: Add required volume of water in a graduated glass or transparent plastic container.
Maltese: Żid il-volum meħtieġ ta' ilma f'tazza gradwata jew f'kontenitur trasparenti tal-plastik.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) għal kull qartas, jiġifieri hija essenzjalment "mingħajr sodium".
English: Negative agreement is the proportion of subjects with a negative ITT (i.e., those who do not have GHD per the ITT) who also have a negative MAC test. With a high level of negative agreement, the MAC test will not wrongly diagnose an individual without GHD per the ITT as having GHD.
Maltese: negattiv (jiġifieri dawk li ma għandhomx il-GHD skont l-ITT) u li għandhom ukoll test MAC negattiv.
English: Concomitant use of strong CYP3A4 inducers with Macimorelin Aeterna Zentaris can decrease macimorelin plasma levels significantly and thereby lead to a false positive result (see also section 4.5).
Maltese: L-użu flimkien ta' indutturi ta' CYP3A4 b'saħħithom ma' Macimorelin Aeterna Zentaris jista' jnaqqas il-livelli ta' macimorelin fil-plażma b'mod sinifikanti u għalhekk iwassal għal riżultat pożittiv falz (ara wkoll is-sezzjoni 4.5).
English: Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone.
Maltese: Macimorelin Aeterna Zentaris huwa indikat bħala test dijanjostiku ta' doża waħda.
English: PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Maltese: GĦAMLA FARMAĊEWTIKA Granuli għal sospensjoni orali f'qartas.
English: Determine the number of Macimorelin Aeterna Zentaris sachets needed based on body weight: one sachet will be required for a patient weighing up to 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Maltese: Stabbilixxi n-numru ta' qratas ta' Macimorelin Aeterna Zentaris meħtieġa abbażi tal-piż tal-ġisem: qartas wieħed ikun meħtieġ għal pazjent ≤ 120 kg, żewġ qratas ikunu meħtieġa jekk il-pazjent jiżen aktar minn 120 kg.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: ECG QT prolonged
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases.
Maltese: It-titwil tal-QT jista' jwassal għal żvilupp ta' takikardija ventrikulari tat-tip ta' torsade de pointes bir-riskju jiżdied hekk kif il-grad ta' prolongament jiżdied.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara s-sezzjoni 6.3. 6.5
English: The test was considered positive (i.e., growth hormone deficiency (GHD) diagnosed) if the maximum serum GH level observed after stimulation was less than the pre-specified cut-off point of 2.8 ng/mL for the MAC test or 5.1 ng/mL for the ITT.
Maltese: osservat wara stimulazzjoni kien inqas mil-linja tal-qtugħ speċifikat minn qabel ta' 2.8 ng/mL għat-test tal-MAC jew ta' 5.1 ng/mL għall-ITT.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
Maltese: AGHD kollha bi probabbilita kbira ta' Grupp A huma individwi
English: Macimorelin Aeterna Zentaris is presented as white to off-white granules for oral suspension.
Maltese: Macimorelin Aeterna Zentaris huwa ppreżentat bħala granuli bojod għal bojod fl-isfar għal sospensjoni orali.
English: The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively.
Maltese: L-estimi għal ftehim negattiv u pożittiv kienu ta' 95% u 86% b'intervalli tal-fiduċja ta' 95% iktar baxxi,
English: • that could increase growth hormone levels: such as clonidine, levodopa, insulin
Maltese: • li jistgħu jżidu l-livelli ta' ormoni li jistimolaw it-tkabbir: bħal clonidine, levodopa, insulina
English: One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Maltese: Qartas wieħed ikun meħtieġ għal pazjent ≤ 120 kg, żewġ qratas ikunu meħtieġa jekk il-pazjent jiżen aktar minn 120 kg.
English: Hypercortisolism has a significant impact on the hypothalamic-pituitary-adrenal axis.
Maltese: cyclooxygenase bħal acetylsalicylic acid jew indometacin).
English: Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.
Maltese: Dewweb il kontenut kollu tal-qartas fl-ilma: qartas wieħed f'120 mL u żewġ qratas f'240 mL, kif applikabbli.
English: QTc prolongation
Maltese: Titwil tal-QTc
English: Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Maltese: Ir-rilaxx ta' ormoni li jinkoraġġixxu t-tkabbir għandu jiġi evalwat bi tliet kampjuni tad-demm miġbura f'45, 60 u 90 minuta wara li jkun ingħata l-prodott mediċinali.
English: You must be fasting for at least 8 hours before you are given Macimorelin Aeterna Zentaris.
Maltese: Għandek tkun sajjem minn tal-anqas għal 8 sigħat qabel ma tingħata Macimorelin Aeterna Zentaris.
English: Therefore, the diagnostic performance of the test may by affected in patients with Cushing's disease or on supra-physiologic glucocorticoid therapy (e.g. systemic administration of doses of hydrocortisone (or its equivalent) in excess of 15 mg/m2/day) and lead to false positive test results.
Maltese: Għalhekk, il prestazzjoni dijanjostika tat-test tista' tkun affettwata fil-pazjenti bil-marda ta' Cushing jew li jkunu qed isegwu terapija tal-glukokortikojde supra-fiżjoloġiku (eż. għoti sistemiku ta' dożi ta' hydrocortisone (jew l-ekwivalenti tiegħu) ta' aktar minn 15 mg/m2/ġurnata) u li jwasslu għal riżultati ta' testijiet pożittivi foloz.
English: Excipient(s) with known effect
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
Maltese: Il-kontenut sħiħ ta' qartas wieħed jiġi mdewweb f'120 mL, u żewġ qratas jiġu mdewba f'240 mL, kif applikabbli.
English: The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
Maltese: sospensjoni rikostitwita fiha 500 mikrogramma ta' macimorelin.
English: • medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
Maltese: • mediċini li jikkoreġu t-taħbit tal-qalb (mediċini antiarritmiċi bħal amiodarone, procainamide,
English: How Macimorelin Aeterna Zentaris is stored 6.
Maltese: Macimorelin Aeterna Zentaris fih is-sodium.
English: • Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
Maltese: • Prodotti mediċinali li jistgħu jżidu temporanjament il-konċentrazzjonijiet tal-ormoni li jinkoraġġixxu t-tkabbir (bħal clonidine, levodopa, u l-insulina).
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10):
English: Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
Maltese: It-twaqqif ta' terapija bl-ormoni li jinkoraġġixxu t-tkabbir (GH) jew bi prodotti mediċinali li jaffettwaw b'mod dirett is-sekrezzjoni pitwitarja ta' somatotropin Il-pazjenti fuq terapija ta' sostituzzjoni bl-ormoni li jistimolaw it-tkabbir (GH, somatotropin) jew li jieħdu prodotti mediċinali li jaffettwaw b'mod dirett is-sekrezzjoni pitwitarja ta' somatotropin (eż.
English: Unopened sachet
Maltese: OĦRA, JEKK MEĦTIEĠA
English: In patients with known congenital or acquired long QT syndrome and in patients with a history of torsades de pointes, the use of macimorelin may only be considered in a cardiovascular clinical unit.
Maltese: F'pazjenti li huma magħrufin li għandhom sindromu konġenitali jew QT twil akkwiżit u f'pazjenti bi storja ta' torsades de pointes, l-użu ta' macimorelin jista' jiġi biss ikkunsidrat f'unità klinika kardjovaskulari.
English: Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream.
Maltese: Macimorelin jaġixxi bħala ormon naturali u jġiegħel lill-glandola pitwitarja tirrilaxxa ormoni li jistimolaw it-tkabbir fil-fluss tad-demm.
English: Aeterna Zentaris GmbH Weismuellerstrasse 50 60314 Frankfurt am Main Germany
Maltese: Aeterna Zentaris GmbH Weismuellerstrasse 50
English: • that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
Maltese: • li jistgħu jnaqqsu r-rispons tal-ormon li jistimola t-tkabbir għal macimorelin bħal: atropina, propylthiouracil, mediċini tal-ormoni li jinkoraġġixxu t-tkabbir
English: The suspension must be administered within 30 minutes after preparation.
Maltese: Is-suspensjoni għandha tintuża fi żmien 30 minuta wara l-preparazzjoni.
English: Determine the number of test sachets needed based on body weight: one sachet will be required for a patient weighing up to 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Maltese: Stabbilixxi n-numru ta' qratas tat-test meħtieġa abbażi tal-piż tal-ġisem: qartas wieħed ikun meħtieġ għal pazjent ≤ 120 kg, żewġ qratas ikunu meħtieġa jekk il-pazjent jiżen aktar minn 120 kg.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
Maltese: Dawn l-anormalitajiet tal-ECG ikkonsistew minn abnormalitajiet ta' mewġa T u f'titwil tal-QTc (ara wkoll is-sezzjoni 4.4).
English: indometacin
Maltese: Il-Ġermanja
English: Macimorelin Aeterna Zentaris granules are to be reconstituted with water and must be used within 30 minutes after preparation.
Maltese: Il-granuli ta' Macimorelin Aeterna Zentaris għandhom jiġu rikostitwiti mal-ilma u għandhom jintużaw fi żmien 30 minuta mill-preparazzjoni.
English: • feeling cold
Maltese: Aħżen fi friġġ.