FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomized to receive injections of ZYPADHERA 405 mg every 4 weeks, 300 mg every 2 weeks, 210 mg every 2 weeks, or placebo every 2 weeks.
Maltese: Il-pazjenti ngħataw b'mod arbitrarju injezzjonijiet ta' ZYPADHERA 405 mg kull 4 ġimgħat, 300 mg kull ġimagħtejn, 210 mg kull ġimagħtejn, jew plaċebo kull ġimagħtejn.
English: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Maltese: • għandek allerġija (tbati minn sensittività eċċessiva) għal olanzapine jew għal xi sustanza oħra ta' din il-mediċina (elenkati fit-taqsima 6).
English: Most of these patients have developed symptoms of sedation (ranging from mild in severity up to coma) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Maltese: Ħafna minn dawn il-pazjenti żviluppaw sintomi ta' sedazzjoni (li jvarjaw minn ħfief fisseverità sa koma) u/jew delirju (inklużi konfużjoni, diżorjentament, aġitazzjoni, ansjetà u indeboliment konoxxittiv ieħor).
English: Bromobutyl stopper with rust colour seal.
Maltese: Tapp ta' bromobutyl b'siġill kulur kannella fl-aħmar.
English: 1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that, immediately prior to a patient leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs or symptoms of overdose - Recommendation that the 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose - Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed - Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur
Maltese: - Ir-rakkomandazzjoni ta' 3 sigħat ta' osservazzjoni fuq il-post wara l-injezzjoni - Ir-rakkomandazzjoni li l-pazjenti għandhom ikunu mgħarrfa li għall-bqija tal-ġurnata ta' linjezzjoni m'għandhomx isuqu jew iħaddmu magni, ikunu attenti għal xi sinjali u sintomi ta' avveniment ta' sindromu ta' wara l-injezzjoni u jkunu jistgħu jirċievu l-għajnuna jekk ikun hemm bżonn.
English: Lipid alterations
Maltese: Mutaġeniċità
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: 1 Ġiet osservata żieda fil-piż klinikament sinifikanti fil-kategoriji kollha fil-linja bażi ta' l-Indiċi tal-Massa tal-Ġisem (BMI).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR
English: The most commonly reported injection site related adverse reaction was pain (5%); some other injection site adverse reactions reported were (in decreasing frequency): nodule type reactions, erythema type reactions, non-specific injection site reactions, irritation, oedema type reactions, bruising, haemorrhage, and anaesthesia.
Maltese: L-aktar reazzjoni avversa li ġiet rrapportata b'mod komuni relatata mas-sit ta' l-injezzjoni kien l-uġigħ (5%); xi reazzjonijiet avversi oħra relatati mas-sit ta' linjezzjoni li ġew irrapportati kienu (b'frekwenza li tonqos): reazzjonijiet tat-tip nodulari, reazzjonijiet tat-tip eritemiku, reazzjonijiet fis-sit ta' l-injezzjoni li mhumiex speċifiċi,
English: Supplementation
Maltese: Astenja
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Maltese: It-tabella li ġejja tiġbor fil-qosor ir-reazzjonijiet avversi rrapportati b'frekwenza akbar f'pazjenti adolexxenti (minn 13 sa 17-il sena) milli f'pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi magħmula għal żmien qasir f'pazjenti adolexxenti.
English: Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
Maltese: ma' kull doża ta' ZYPADHERA (405 mg kull 4 ġimgħat, 300 mg kull ġimagħtejn, u 210 mg kull ġimagħtejn) meta mqabbel ma' plaċebo (tibdil medju -8.51).
English: Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
Maltese: Effetti sekondarji rari (li jistgħu jaffettwaw sa 1 minn kull 1000 persuni) b'ZYPADHERA
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Maltese: M'hemmx tagħrif miġbur b'mod sistematiku li jindirizza speċifikament il-bdil ta' pazjenti minn ZYPADHERA għal prodotti mediċinali antipsikotici oħra.
English: In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Maltese: Fi studji kliniċi b'olanzapine trab għal soluzzjoni għall-injezzjoni jew ZYPADHERA, olanzapine ma kienx assoċjat ma' żieda persistenti fil-QT assolut jew fl-intervalli QTc.
English: Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.
English: 3 ml solvent: Type I glass vial.
Maltese: Solvent ta' 3 ml: Kunjett tal-ħġieġ Tip I.
English: How to store ZYPADHERA
Maltese: Mediċini oħra u ZYPADHERA
English: There is no specific antidote for olanzapine.
Maltese: M'hemm l-ebda antidotu speċifiku għal olanzapine.
English: These events occurred in about 0.1 to 1.1% of patients.
Maltese: (1.3% kontra 0.4%, rispettivament).
English: Eli Lilly Italia S.p.A. Tel: + 39 055 42571
Maltese: Tel: + 39 055 42571
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Maltese: Kura sintomatika u monitoraġġ tal-funzjoni ta' l-organi vitali għandhom jiġu stabbiliti skont il-qagħda klinika, inkluż kura għall-pressjoni baxxa u kolass taċ-ċirkolazzjoni u sosteniment tal-funzjoni respiratorja.
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija tal-ġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: Only slight to moderate increase in olanzapine clearance has been observed.
Maltese: Ġiet osservata żieda żgħira sa moderata biss fittneħħija ta' olanzapine.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Reazzjoni għallMediċina b'Eosinofilja u Sintomi Sistemiċi
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Olanzapine jista' jantagonizza l-effetti ta' l-agonisti diretti jew indiretti ta' dopamine.
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Maltese: Fi studji kliniċi f'pazjenti b'psikożi dovuta għal mediċina (agonist ta' dopamine) assoċjata mal marda ta' Parkinson, kienu rrapportati deterjorament tas-sintomatoloġija tal-marda ta' Parkinson u l-alluċinazzjonijiet b'mod komuni ħafna u aktar spiss mill-plaċebo.
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Maltese: Żieda filpiż klinikament sinifikanti (≥ 7%) tidher li sseħħ aktar frekwentement fil-popolazzjoni ta' ladolexxenti meta mqabbla ma' l-adulti b'espożizzjoni simili.
English: Figure C: Vigorously shake vial
Maltese: Trab: solidu isfar
English: Repeated-dose toxicity
Maltese: Tossiċità b'dożi rrepetuti
English: If you miss an injection of ZYPADHERA
Maltese: Jekk taqbeż injezzjoni ta' ZYPADHERA
English: • Reconstitution and Administration card (this leaflet)
Maltese: • Biljett għar-Rikostituzzjoni u Amministrazzjoni (dan il-fuljett)
English: Butyl stopper with purple seal.
Maltese: Tapp ta' butyl b'siġill vjola.
English: Reporting of side effects
Maltese: Preparament ta' materjali
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Maltese: Olanzapine mhux irrakkomandat għall-użu f'pazjenti b'psikożi relatata mad-demenzja u/jew disturbi fl-imġiba minħabba żieda fil-mortalità u r-riskju ta' puplesija.
English: Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Maltese: Sinjali kliniċi inkludew sedazzjoni, atassja, rogħda, żieda fir-rata tal-qalb, diffikultà fir-respirazzjoni, tidjiq tal-pupilla ta'
English: Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Maltese: ketoaċidożi jew koma kienu rrappurtati b'mod mhux komuni, inklużi xi każijiet fatali (ara taqsima 4.8).
English: In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Maltese: Fi studji kliniċi f'pazjenti anzjani bid-demenzja, kura b'olanzapine kienet assoċjata ma' inċidenza ogħla ta' mwiet u reazzjonijiet avversi ċerebrovaskulari meta mqabbla mal-plaċebo (ara wkoll taqsima 4.4).
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine
Maltese: Kartuna ta' Barra ZYPADHERA 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Oral olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Maltese: Olanzapine mill-ħalq inbeda b'2.5 mg/jum u żdied bil-mod għallmassimu ta' 15 mg/jum fuq il-bażi tal-ġudizzju tar-riċerkatur.
English: This table confirms the final ZYPADHERA suspension volume to inject.
Maltese: Din it-tabella tikkonferma l-volum finali ta' suspensjoni ta' ZYPADHERA li għandu jiġi injettat.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine
Maltese: Kartuna ta' Barra ZYPADHERA 405 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
Maltese: Jekk pazjent jiżviluppa sinjali u sintomi ta' NMS, jew ikollu deni għoli bla ebda spjegazzjoni mingħajr manifestazzjonijiet kliniċi oħra ta' NMS, għandhom jitwaqqfu l-mediċini antipsikotiċi kollha, inkluż olanzapine.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine
Maltese: Kartuna ta' Barra ZYPADHERA 210 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Maltese: Sinjali oħra jistgħu jinkludu creatine phosphokinase elevat, mijoglobina fl-urina (rabdomajoliżi) u indeboliment akut tal-kliewi.
English: Oral olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Maltese: Olanzapine mill-ħalq intuża bħala doża flessibbli li tibda b'2.5 u titla' sa 20 mg/jum.
English: Eli Lilly and Company (Ireland) Limited Tel: + 353 (0) 1 661 4377
Maltese: Eli Lilly farmacevtska družba, d.o.o. Tel: + 386 (0) 1 580 00 10
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ZYPADHERA 405 mg powder for prolonged release injection olanzapine
Maltese: ZYPADHERA 405 mg trab għall-injezzjoni li terħi l-mediċina bil-mod olanzapine
English: Injection site related adverse events
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Absorption
Maltese: Fertilità
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Maltese: L-inċidenza ogħla ta' mwiet ma ġietx assoċjata mad-doża ta' olanzapine (doża medja kuljum ta' 4.4 mg) jew it-tul ta' żmien tal-kura.
English: The combined 150 mg and 300 mg/2 week treatment group was non inferior to the 405 mg/4 week treatment group (exacerbation rates 10% for each group) at 24 weeks after randomisation.
Maltese: 300 mg/ġimagħtejn ma kienx inferjuri għall-grupp ta' kura b'405 mg/4 ġimgħat (rati ta' iggravar ta' 10% għal kull grupp) fl-24 ġimgħa wara randomisation.
English: Oedema
Maltese: Doża
English: When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
Maltese: Meta jkun hemm aktar minn fattur wieħed li jista' jirriżulta f'metaboliżmu aktar bil-mod (sess femminili, età ġerjatrika, individwu li ma jpejjipx), għandha tingħata kunsiderazzjoni biex titnaqqas id-doża.
English: Thrombocytopenia
Maltese: Newrolettiku
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Maltese: 2 Iż-żidiet medji fil-livelli tal-lipidi waqt is-sawm (kolesterol totali, LDL kolesterol, u trigliċeridi)
English: Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Maltese: Fuq bazi ta' riżultati minn studji orali fuq il-ġrieden u l-firien, ġie konkluż li olanzapine m'huwiex karċinoġenu.
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Maltese: Fi studji kliniċi, ġie rrappurtat b'mod komuni ħafna u aktar ta' spiss li s-sintomatoloġija ta' Parkinson u l-alluċinazzjonijiet imorru għall-agħar aktar milli bil-plaċebo (ara taqsima 4.8), u olanzapine mill-ħalq ma kienx aktar effettiv mill-plaċebo fil-kura tas-sintomi psikotiċi.
English: Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
Maltese: Fil-kunjett, ZYPADHERA rikostitwit jibqa' stabbli sa 24 siegħa.
English: ≥ 75 to < 100*
Maltese: ≥ 75 sa < 100*
English: Harcourt Centre, Harcourt Road Dublin 2, Ireland
Maltese: Harcourt Centre, Harcourt Road Dublin 2, L-Irlanda
English: ABF Pharmaceutical Services GmbH Brunnerstraße 63/18-19
Maltese: Pharmaceutical Services GmbH Brunnerstraße 63/18-19
English: INJECTION 6.
Maltese: INJEZZJONI 6.
English: V30M TTR mutation1, n (%)
Maltese: Mutazzjoni TTR V30M1, n (%)
English: Placebo (N=60)
Maltese: Plaċebo (N=60)
English: Unchanged inotersen is the predominant circulating component.
Maltese: Inotersen mhux mibdul huwa l-komponent ċirkolanti predominanti.
English: Subgroup n (Placebo, Inotersen)
Maltese: Sottogrupp n (Plaċebo, Inotersen)
English: Subgroup Analysis of mNIS+7 and Norfolk QoL-DN mNIS+7
Maltese: Analiżi tas-Sottogrupp ta' mNIS+7 u Norfolk QoL-DN mNIS+7
English: Baseline n
Maltese: Linja bażi n
English: Other most commonly reported adverse reactions with inotersen were nausea (31.3%), anaemia (27.7%), headache (23.2%), pyrexia (19.6%), peripheral oedema (18.8%), chills (17.9%), vomiting (15.2%), thrombocytopenia (13.4%) and platelet count decreased (10.7%).
Maltese: Reazzjonijiet avversi oħra li ġew irrappurtati bl-aktar mod komuni b'inotersen kienu nawsja (31.3%), anemija (27.7%), uġigħ ta' ras (23.2%), deni (19.6%), edema periferali (18.8%), dehxiet ta' bard (17.9%), rimettar (15.
English: Dosing should be paused until 3 successive values > 100.
Maltese: temporanju sa 3 valuri suċċessivi > 100.
English: Estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m
Maltese: Rata tal-filtrazzjoni glomerulari stmata (eGFR, estimated glomerular filtration rate) < 45 ml/min/1.73 m².
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 July 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06 ta' Lulju 2018
English: Three (3%) patients developed platelet counts < 25 x 10
Maltese: Tliet (3 %) tal-pazjenti żviluppaw għadd tal-pjastrini < 25 x 10
English: Table 2 presents the adverse reactions (ADRs) listed by MedDRA system organ class.
Maltese: Tabella 2 tippreżenta r-reazzjonijiet avversi (ADRs, adverse reactions) imniżżlin skont is-sistema talklassifika tal-organi MedDRA.
English: Age (years), mean (SD) Age 65 years and older, n (%) Male, n (%) mNIS+7, mean (SD)
Maltese: Età (snin), medja (SD) Età 65 sena jew ikbar, n (%) Irġiel, n (%) mNIS+7, medja (SD) Norfolk QoL-DN, medja (SD) Stadju tal-marda, n (%)
English: Thrombocytopenia Anaemia
Maltese: Tromboċitopenja Anemija
English: mean (SD) hATTR-CM Disease Duration
Maltese: medja (SD) Durata tal-Marda hATTR-CM
English: P-value n (Placebo, Inotersen)
Maltese: valur-p n (Plaċebo, Inotersen)
English: In the pivotal NEURO-TTR study, in the inotersen treatment group, robust reduction in circulating TTR levels was observed throughout the 15-month treatment period, with mean percent changes from baseline in serum TTR ranging from 68.41% to 74.03% (median range: 74.64% to 78.98%) from Week 13 to Week 65 (Figure 1).
Maltese: NEURO-TTR, fil-grupp ta' kura b'inotersen, ġie osservat tnaqqis robust fiċċirkolazzjoni tal-livelli ta' TTR matul il-perjodu ta' kura ta' 15-il xahar, b'tibdil perċentwali medju mil-linja bażi fit-TTR fis-seru li jvarja minn 68.41 % sa 74.03 % (medda medjana: 74.64% sa 78.98%) minn Ġimgħa 13 sa Ġimgħa 65 (Figura 1).
English: Primary Endpoint Analysis mNIS+7 and Norfolk QoL-DN
Maltese: Analiżi tal-Punt aħħari Primarju mNIS+7 u Norfolk QoL-DN
English: TTR is a carrier protein for retinol binding protein 4 (RBP4) which is the principal carrier of vitamin A (retinol).
Maltese: TTR hija proteina ġarriera għall-proteina tal-irbit 4 ta' retinol (RBP4, retinol binding protein 4) li hija l-ġarriera prinċipali tal-vitamina A (retinol).
English: Table 1 .
Maltese: Tabella 1.
English: Yes No hATTR-CM2, n (%) hATTR-PN Disease Duration3 (months)
Maltese: Le hATTR-CM², n (%) Durata tal-Marda hATTR-PN3 (xhur)
English: Urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) prior to treatment.
Maltese: Proporzjon ta' proteina għall-kreatinina fl-awrina (UPCR, urine protein to creatinine ratio) ≥ 113 mg/mmol (1 g/g) qabel il-kura.
English: Inotersen is a 2′-O-2-methoxyethyl (2′-MOE) phosphorothioate antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production.
Maltese: 2′-O-2-methoxyethyl (2′-MOE) tal-produzzjoni ta' transthyretin (TTR) filbniedem.
English: Stage 2
Maltese: Stadju 2
English: Also contains: hydrochloric acid, sodium hydroxide, water for injections.
Maltese: TA' EĊĊIPJENTI Fih ukoll: hydrochloric acid, sodium hydroxide, ilma għall-injezzjonijiet.
English: Glomerulonephritis / kidney problems
Maltese: Glomerulonefrite / problemi fil-kliewi
English: In addition, the corresponding frequency category for each ADR is based on 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: Barra minn hekk, ilkategorija ta' frekwenza korrispondenti għal kull ADR hija bbażata fuq il-konvenzjoni li ġejja: 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: How to store Tegsedi 6.
Maltese: Kif taħżen Tegsedi 6.
English: Tegsedi contains the active substance inotersen.
Maltese: Tegsedi fih is-sustanza attiva inotersen.
English: The NEURO-TTR multicentre, double-blind, placebo-controlled trial was comprised of 172 treated patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).
Maltese: Il-prova multiċentrika, double-blind, ikkontrollata bil-plaċebo NEURO-TTR inkludiet 172 pazjent ikkurati b'amijolojdożi ta' transthyretin ereditarja b'polinewropatija (hATTR-PN).
English: In the case of UPCR ≥ 2 g/g (226 mg/mmol), which is confirmed on repeat testing, dosing of inotersen should be paused while further evaluation for acute glomerulonephritis is performed.
Maltese: Fil-każ ta' UPCR ≥ 2 g/g (226 mg/mmol), li jiġi kkonfermat minn ittestjar ripetut, id-dożaġġ ta' inotersen għandu jitwaqqaf b'mod temporanju waqt li ssir aktar evalwazzjoni ta' glomerulonefrite akuta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1296/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1296/001
English: In the Phase 3, NEURO-TTR trial, platelet count reductions to below normal (140 x 109/L ) were observed in 54% of patients treated with inotersen and 13% of placebo patients; reductions to below 100 x 10
Maltese: Filprova ta' Fażi 3, NEURO-TTR, tnaqqis fl-għadd tal-pjastrini għal taħt in-normal (140 x 109/L ) ġie osservat f'54 % tal-pazjenti kkurati b'inotersen u fi 13 % tal-pazjenti bil-plaċebo; tnaqqis għal taħt 100 x 10
English: Inotersen should not be used in patients with a urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) or estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 (see section 4.3).
Maltese: Inotersen m'għandux jintuża f'pazjenti bi proporzjon ta' proteina għal kreatinina flawrina (UPCR) ta' ≥ 113 mg/mmol (1 g/g) jew rata tal-filtrazzjoni glomerulari (eGFR, estimated glomerular filtration rate) ta' < 45 ml/min/1.73 m² (ara sezzjoni 4.3).
English: 9/L were observed in 23% of patients treated with inotersen and 2% of the patients receiving placebo; confirmed platelet counts of < 75 x 109/L were observed in 10.7% of inotersen-treated patients.
Maltese: 9/L ġie osservat fi 23 % tal-pazjenti kkurati b'inotersen u fi 2 % tal-pazjenti li rċivew ilplaċebo; l-għadd tal-pjastrini kkonfermat ta' < 75 x 109/L ġie osservat f'10.7 % tal-pazjenti kkurati b'inotersen.
English: PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless to pale yellow solution (pH 7.5 - 8.8)
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni (injezzjoni) Soluzzjoni ċara, bla kulur għal safra ċara (pH 7.5 - 8.8)