FrancophonIA/ELRC3.0 huggingface dataset:
English: Glomerulonephritis Proteinuria Renal failure
Maltese: Glomerulonefrite Proteinurija
English: Stage 1
Maltese: Stadju 1
English: EXP
Maltese: ABF
English: Results across multiple disease characteristics [TTR mutation (V30M, non-V30M)], disease stage (Stage 1, Stage 2), previous treatment with tafamidis or diflunisal (yes, no), presence of hATTR-CM (yes, no) at Week 66 showed statistically significant benefit in all subgroups based on mNIS+7 composite score and all but one of these subgroups (CM-Echo Set; p=0.067) based on Norfolk QoL-DN total score (Table 5).
Maltese: Ir-riżultati fil-karatteristiċi tal-marda multipla [mutazzjoni TTR (V30M, mhux V30M)], stadju tal-marda (Stadju 1, Stadju 2), kura preċedenti b'tafamidis jew diflunisal (iva, le), preżenza ta' hATTR-CM (va, le) f'Ġimgħa 66 urew benefiċċju statistikament sinifikanti fis-sottogruppi kollha abbażi tal-punteġġ kompost mNIS+7 u dawn is-sottogruppi kollha ħlief wieħed (CM-Echo Set, p=0.067) abbażi tal-punteġġ totali ta' Norfolk QoL-DN (Tabella 5).
English: Inotersen is not a substrate for CYP450 metabolism, and is metabolised in tissues by endonucleases to form shorter inactive oligonucleotides that are the substrates for additional metabolism by exonucleases.
Maltese: Inotersen mhuwiex substrat għall-metaboliżmu ta' CYP450, u jiġi metabolizzat fit-tessuti minn endonukleażi sabiex jifforma oligonukleotidiċi mhux attivi iqsar li huma substrati għal metaboliżmu addizzjonali minn ekżonukleażi.
English: The active substance in Tegsedi, inotersen, is a type of medicine called an antisense oligonucleotide inhibitor.
Maltese: Is-sustanza attiva f'Tegsedi, inotersen, hija tip ta' mediċina msejħa inibitur oligonukleotidiku kontra ssensi.
English: Extensive and persistent uptake of inotersen was observed by various cell types in multiple organs of all tested animal species including monocytes/macrophages, kidney proximal tubular epithelia, Kupffer cells of the liver, and histiocytic cell infiltrates in lymph nodes and injection sites.
Maltese: It-teħid estensiv u persistenti ta' inotersen ġie osservat minn diversi tipi ta' ċelluli f'bosta organi talispeċi ta' annimali kollha ttestjati inkluż monoċiti/makrofaġi, epitelji tubulari prossimali tal-kliewi, ċelluli Kupffer tal-fwied, u infiltrati taċ-ċellula istjoċitika f'limfonodi u siti tal-injezzjoni.
English: Symptoms of low vitamin A include:
Maltese: Defiċjenza tal-Vitamina A
English: Tegsedi may be stored unrefrigerated for up to 6 weeks below 30 °C.
Maltese: Tegsedi jista' jinħażen mhux fi friġġ sa 6 ġimgħat taħt 30 °C.
English: Wait seconds
Maltese: Stenna sekondi
English: Inotersen is highly bound to human plasma protein (> 94%) and the fraction bound is independent of drug concentration.
Maltese: Inotersen jintrabat ħafna mal-proteina fil-plażma tal-bniedem (> 94%) u l-proporzjon marbut jiddependi fuq il-konċentrazzjoni tal-mediċina.
English: Due to the long half-life of inotersen (see section 5.2), a vitamin A deficit may even develop after cessation of treatment.
Maltese: Minħabba n-nofs ħajja ta' inotersen (ara sezzjoni 5.2), jista' jiżviluppa defiċit tal-vitamina A anki wara t-twaqqif tal-kura.
English: Subjects with Stage 1 and Stage 2 hATTR-PN and an NIS ≥10 and ≤130 were recruited in the pivotal NEURO-TTR study.
Maltese: Individwi b'hATTR-PN fi Stadju 1 u Stadju 2 u NIS ≥10 u ≤130 ġew reklutati fl
English: P-value
Maltese: valur-p
English: Change from Baseline Inotersen - Placebo
Maltese: Bidla mil-Linja bażi Inotersen - Plaċebo
English: List of adverse reactions in clinical studies
Maltese: Lista ta' reazzjonijiet avversi fl-istudji kliniċi
English: Pharmacotherapeutic group: Other Nervous System Drugs, ATC code: N07XX15
Maltese: Mediċini oħra għas-sistema nervuża, Kodiċi ATC:
English: CM-Echo Set p<0.001
Maltese: Sett Mhux CM-Eko p<0.001
English: Development of anti-drug antibodies to inotersen was characterised by late onset (median onset > 200 days) and low titer (median peak titer of 284 in the pivotal study).
Maltese: L-iżvilupp ta' antikorpi kontra l-mediċina ta' inotersen ġie kkaratterizzat minn bidu tard (bidu medjan > 200 jum) u titer baxx (l-ogħla titer medjan ta' 284 flistudju pivotali).
English: Week 66
Maltese: Ġimgħa 66
English: Previous use of stabilisers p<0.001
Maltese: Użu preċedenti ta' stabilizzaturi p<0.001
English: INFORMATION IN BRAILLE Tegsedi
Maltese: Kif taħżen Tegsedi
English: Based on the mechanism of action, inotersen is expected to reduce plasma vitamin A (retinol) below normal levels (see section 5.1).
Maltese: Abbażi tal-mekkaniżmu ta' azzjoni, inotersen mistenni jnaqqas il-vitamina A fil-plażma (retinol) taħt livelli normali (ara sezzjoni 5.1).
English: Daily until 2 successive values above 25.
Maltese: Kuljum sa 2 valuri suċċessivi 'l fuq minn 25.
English: The apparent volume of distribution of inotersen at steady-state is 293 L in patients with hATTR.
Maltese: Il-volum apparenti ta' distribuzzjoni ta' inotersen fi stat fiss huwa 293 L f'pazjenti b'hATTR.
English: Furthermore, results across the components of mNIS+7 and domains of Norfolk QoL-DN composite scores were consistent with the primary endpoint analysis, showing benefit in motor, sensory and autonomic neuropathies (Figure 2).
Maltese: Barra minn hekk, ir-riżultati fil-komponenti ta' mNIS+7 u fid-dominji talpunteġġi komposti ta' Norfolk QoL-DN kienu konsistent mal-analiżi tal-punt aħħari primarju, billi wrew benefiċċju fin-newropatiji motoriċi, sensorji u awtonomiċi (Figura 2).
English: Difference in Least Squares Mean (LSM) Change from Baseline Between Treatment Groups in mNIS+7 and Components
Maltese: Differenza fil-Bidla tal-Medja tal-Inqas Kwadri (LSM, Least Squares Mean) milLinja Bażi bejn il-Gruppi ta' Kura f'mNIS+7 u l-Komponenti
English: % Change from Baseline LSM ( SE)
Maltese: % Change from Baseline LSM (
English: The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions (50.9%).
Maltese: Ir-reazzjonijiet avversi li ġew osservati bl-aktar mod frekwenti waqt kura b'inotersen kienu avvenimenti assoċjati ma' reazzjonijiet fis-sit tal-injezzjoni (50.9%).
English: Week 66 Change n LSM (SE) 95% CI Difference in LSM (Tegsedi - Placebo) 95% CI P-value
Maltese: (Tegsedi - Plaċebo) 95% CI Valur-p
English: Elderly population No overall differences in pharmacokinetics were observed between other adult and elderly patients.
Maltese: Popolazzjoni anzjana Ma ġiet osservata l-ebda differenza fil-farmakokinetika bejn pazjenti adulti oħra u l-anzjani.
English: Caution should be used with anithrombotic medicinal products, antiplatelet medicinal products, and medicinal products that may lower platelet count, for example acetylsalicyclic acid, clopidogrel, warfarin, heparin, low-molecular weight heparins, Factor Xa inhibitors such as rivaroxaban and apixaban, and thrombin inhibitors such as dabigatran (see section 4.4).
Maltese: Għandha tintuża l-kawtela bi prodotti mediċinali anitrombotiċi, prodotti mediċinali kontra l-pjastrini, u prodotti mediċinali li jistgħu jbaxxu l-għadd tal-pjastrini, pereżempju acetylsalicyclic acid, clopidogrel, warfarin, eparina, eparini b'piż molekulari baxx, inibituri ta' Fattur Xa bħal rivaroxaban u apixaban, u inibituri ta' trombina bħal dabigatran (ara sezzjoni 4.4).
English: Renal function decline has also been observed in a number of subjects without signs of glomerulonephritis (see section 4.8).
Maltese: Ġie osservat ukoll tnaqqis filfunzjoni tal-kliewi f'numru ta' individwi mingħajr sinjali ta' glomerulonefrite (ara sezzjoni 4.8).
English: Patients were stratified for stage of disease (Stage 1 versus Stage 2), TTR mutation (V30M versus non-V30M) and previous treatment with either tafamidis or diflunisal (yes versus no).
Maltese: Il-pazjenti ġew stratifikati għal stadju tal-marda (Stadju 1 kontra Stadju 2), mutazzjoni TTR (V30M kontra mhuxV30M) u kura preċedenti b'jew tafamidis jew diflunisal (iva kontra le).
English: Urinary recovery of the parent medicinal product is limited to less than 1% within the 24 hours post dose.
Maltese: L-irkupru tal-awrina tal-prodott mediċinali prinċipali huwa limitat għal inqas minn 1 % fi żmien l-24 siegħa wara d-doża.
English: • Advise HCPs that if the platelet count falls below 25 x 109/L, Tegsedi treatment should be permanently discontinued and corticosteroid therapy is recommended;
Maltese: • twissi lill-HCPs li jekk l-għadd tal-plejtlits jinżel taħt 25 x 109/L, il-kura b'Tegsedi għandha titwaqqaf b'mod permanenti u hija rrakkomandata terapija bil-kortikosterojdi;
English: Non-CMEcho Set p<0.001
Maltese: Sett CMEko p<0.001
English: (months)
Maltese: (SE)
English: Patients receiving inotersen should take oral supplementation of approximately 3,000 IU vitamin A per day in order to reduce the potential risk of ocular toxicity due to vitamin A deficiency.
Maltese: Il-pazjenti li jirċievu inotersen għandhom jieħdu supplimentazzjoni orali ta' madwar 3,000 IU vitamina A kuljum sabiex inaqqsu r-riskju potenzjali ta' tossiċità okulari minħabba defiċjenza talvitamina A.
English: The changes from baseline in both primary endpoints (mNIS+7 and Norfolk QoL-DN) demonstrated statistically significant benefit in favour of inotersen treatment at Week 66 (Table 4).
Maltese: Il-bidliet mil-linja bażi fiż-żewġ punti aħħarin primarji (mNIS+7 u Norfolk QoL-DN) urew benefiċċju statistikament sinifikanti favur kura b'inotersen f'Ġimgħa 66 (Tabella 4).
English: PREPARATION
Maltese: PREPARAZZJONI
English: The recommended dose is 284 mg inotersen by subcutaneous injection.
Maltese: Id-doża rakkomandata hija 284 mg inotersen permezz ta' injezzjoni taħt il-ġilda.
English: The primary efficacy endpoints were the change from baseline to Week 66 in the modified Neuropathy Impairment Score + 7 tests (mNIS+7) composite score and in the Norfolk Quality of Life - Diabetic Neuropathy (QoL-DN) questionnaire total score.
Maltese: Il-punti aħħarin tal-effikaċja primarji kienu l-bidla mil-linja bażi għal Ġimgħa 66 fil-punteġġ kompost tat-testijiet tal-Punteġġ + 7 ta' Indeboliment tan-Newropatija modifikat (mNIS+7, modified Neuropathy Impairment Score + 7 tests) u fil-punteġġ totali talkwestjonarju Norfolk Kwalità tal-Ħajja - Newropatija Dijabetika (QoL-DN).
English: What Tegsedi contains - The active substance is inotersen.
Maltese: X'fih Tegsedi - Is-sustanza attiva hi inotersen.
English: Tegsedi can lower your body's levels of vitamin A (also called retinol).
Maltese: Tegsedi jista' jbaxxi l-livelli tal-vitamina A tal-ġisem tiegħek (imsejħa wkoll retinol).
English: No
Maltese: JIS
English: • Let the pre-filled syringe reach room temperature (20 °C to 25 °C) for 30 minutes before injecting it. Do not warm the pre-filled syringe in any other way.
Maltese: • Ħalli s-siringa mimlija għal-lest tilħaq temperatura ambjentali (20 °C sa 25 °C) għal 30 minuta qabel tinjettaha.
English: • Remove the plastic tray from the carton and check the expiry date.
Maltese: • Neħħi t-trej tal-plastik mill-kartuna u ċċekkja d-data ta' skadenza.
English: Inotersen did not exhibit genotoxic potential in in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Maltese: Inotersen ma weriex riskju ta' effett tossiku fuq il-ġeni f'in vitro u in vivo u ma kienx karċinoġeniku fi ġrieden rasH2 transġeniċi.
English: In the case of a decrease in eGFR >30%, in the absence of an alternative explanation, pausing of inotersen dosing should be considered pending further evaluation of the cause.
Maltese: Fil-każ ta' tnaqqis fl-eGFR >30%, fin-nuqqas ta' spjegazzjoni alternattiva, il-waqfien temporanju taddożaġġ ta' inotersen għandu jiġi kkunsidrat pendenti minn aktar evalwazzjoni tal-kawża.
English: The most frequently observed events included events associated with injection site reactions (includes injection site pain, erythema, pruritus, swelling, rash, induration, bruising and haemorrhage).
Maltese: L-avvenimenti osservati bl-aktar mod frekwenti assoċjati ma' reazzjonijiet fis-sit tal-injezzjoni (tinkludi uġigħ, eritema, prurite, nefħa, raxx, indurazzjoni, tbenġil u emorraġija fis-sit tal-injezzjoni).
English: Although the population PK analysis did not identify clinically relevant effects of some nephrotoxic medicines on the clearance of inotersen or on the potential for an effect on renal function, a systematic assessment of co-administration of inotersen and potentially nephrotoxic medicinal products has not been conducted.
Maltese: Għalkemm l-analiżi tal-PK talpopolazzjoni ma identifikatx effetti klinikament rilevanti ta' xi mediċini nefrotossiċi fuq it-tneħħija ta' inotersen jew fuq il-potenzjal għal effett fuq il-funzjoni tal-kliewi, ma saritx valutazzjoni sistematika tal-għoti flimkien ta' inotersen u prodotti mediċinali potenzjalment nefrotossiċi.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: Inotersen was not evaluated in patients undergoing liver transplantation in clinical trials (section 4.2).
Maltese: Inotersen ma ġiex evalwat f'pazjenti li sarilhom trapjant tal-fwied fil-provi kliniċi (sezzjoni 4.2).
English: Prior to the launch of Tegsedi in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel it-tnedija ta' Tegsedi f'kull Stat Membru (SM), id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) għandu jaqbel fuq il-kontenut u l-format tal-materjali edukattivi, inkluż fuq il-mezzi ta' komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u fuq kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali (NCA, National Competent Authority).
English: ‡ Additional risk factors for bleeding include age >60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events † It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline.
Maltese: ‡Fatturi ta' riskju addizzjonali għal fsada jinkludu età >60 sena, li wieħed jirċievi prodotti mediċinali antikoagulanti jew kontra l-pjastrini, u /jew storja preċedenti ta' avvenimenti maġġuri ta' fsada †
English: In the placebo group, mean serum TTR concentration decreased by 8.50% at Week 3 and then remained fairly constant throughout the treatment period.
Maltese: Fil-grupp tal-plaċebo, il-konċentrazzjoni ta' TTR fis-seru medja naqset b'8.50 % f'Ġimgħa 3 imbagħad baqgħet kostanti sew matul il-perjodu ta' kura.
English: Glomerulonephritis has occurred in patients treated with inotersen (see section 4.8).
Maltese: Seħħet glomerulonefrite f'pazjenti kkurati b'inotersen (ara sezzjoni 4.8).
English: 9/L; one of these patients experienced a fatal intracranial haemorrhage.
Maltese: 9/L; wieħed minn dawn ilpazjenti esperjenza emorraġija intrakranjali fatali.
English: Inotersen is not primarily cleared by metabolism in the liver, not a substrate for CYP450 oxidation, and metabolized broadly by nucleases in all tissues of distribution.
Maltese: Inotersen ma jitneħħiex primarjament mill-metaboliżmu fil-fwied, mhuwiex substrat għal ossidazzjoni ta' CYP450 u jiġi metabolizzat l-aktar minn nukleażi fit-tessuti kollha tad-distribuzzjoni.
English: Decreased platelet counts were observed in chronic toxicity studies in mice, rats and monkeys at 1.4 to 2-fold the human AUC at the recommended therapeutic inotersen dose.
Maltese: Ġie osservat għadd tal-pjastrini mnaqqas fi studji dwar l-effett tossiku kroniku fil-ġrieden, fil-firien u fix-xadini b'1.4 sa darbtejn l-AUC fil-bniedem bid-doża terapewtika rakkomandata ta' inotersen.
English: Baseline demographics
Maltese: Tabella 3. Demografiċi fil-linja bażi
English: - The other ingredients are water for injections, sodium hydroxide, and hydrochloric acid.
Maltese: - Is-sustanzi mhux attivi l-oħrajn huma ilma għall-injezzjonijiet, sodium hydroxide, u hydrochloric acid.
English: In monkeys, perivascular cell infiltration by lymphohistiocytic cells in multiple organs was noted.
Maltese: Fix-xadini, ġiet innutata infiltrazzjoni taċ-ċellula perivaskulari minn ċelluli limfoistojtiċi f'bosta organi.
English: - Medicines to prevent blood clots or that lower the platelet numbers in your blood, e.g., acetylsalicylic acid, heparin, warfarin, clopidogrel, rivoraxaban and dabigatran.
Maltese: - Mediċini biex jipprevjenu l-koagulazzjoni tad-demm jew li jbaxxu n-numri tal-pjastrini fiddemm tiegħek, eż., acetylsalicylic acid, eparina, warfarin, clopidogrel, rivoraxaban u dabigatran.
English: Consider more frequent monitoring if additional risk factors for bleeding are present.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti jekk hemm preżenti fatturi ta' riskju addizzjonali għal fsada.
English: Injection site reactions Peripheral oedema
Maltese: Edema periferali
English: Tegsedi is a clear, colourless to pale yellow solution (pH 7.5 - 8.8) for injection (injection) in a pre-filled syringe.
Maltese: Tegsedi huwa soluzzjoni (pH 7.5 - 8.8) ċara, bla kulur għal safra ċara għall-injezzjoni (injezzjoni) f'siringa mimlija għal-lest.
English: These pro-inflammatory organ changes were observed at 1.4 to 6.6-fold the human AUC at the recommeded therapeutic dose in all animal species tested and were accompanied by increases of various plasma cytokines/chemokines.
Maltese: Dan it-tibdil proinfjammatorju fl-organi ġie osservat b'1.4 sa 6.6 darbiet l-AUC fil-bniedem bid-doża terapewtika rakkomandata fl-ispeċi ta' annimali kollha ttestjati u kien akkumpanjat minn żidiet ta' diversi ċitokini/kimokini fil-plażma.
English: • dry eyes, poor vision, decrease in night vision, hazy or cloudy vision
Maltese: • għajnejn xotti, vista batuta, tnaqqis fil-vista billejl, vista mċajpra
English: The kidney accumulation of inotersen was associated with proteinuria in rats at 13.4-fold the human AUC at the recommended therapeutic inotersen dose.
Maltese: Lakkumulazzjoni fil-kliewi ta' inotersen ġiet assoċjata ma' proteinurja fil-firien b'13.4 darbiet l-AUC fil-bniedem bid-doża rakkomandata terapewtika ta' inotersen.
English: Caution should be exercised with concomitant use of nephrotoxic medicinal products and other medicines that may impair renal function, such as sulfonamides, aldosterone antagonists, anilides, natural opium alkaloids and other opiods (see section 4.4).
Maltese: Għandha tiġi eżerċitata l-kawtela b'użu konkomitanti ta' prodotti mediċinali nefrotossiċi u mediċini oħra li jistgħu jindebolaw il-funzjoni tal-kliewi, bħal sulfonamidi, antagonisti ta' aldosterone, anilidi, alkalojdi tal-oppju naturali u opjojdi oħra (ara sezzjoni 4.4).
English: The selective binding of inotersen to the TTR messenger RNA (mRNA) causes the degradation of both mutant and wild type (normal) TTR mRNA.
Maltese: L-irbit selettiv ta' inotersen mal-messaġġier ta' TTR RNA (mRNA) jikkawża ddegradazzjoni ta' kemm TTR mRNA mutanti kif ukoll tat-tip selvaġġ (normali).
English: Consider corticosteroids if additional risk factors for bleeding are present.
Maltese: Ikkunsidra l-kortikosterojdi jekk hemm preżenti fatturi ta' riskju addizzjonali għal fsada.
English: Defined as all patients with a diagnosis of hereditary transthyretin amyloidosis with cardiomyopathy (hATTR-CM) at study entry or left ventricular wall thickness >1.3 cm on echocardiogram without a known history of persistent hypertension Duration from symptom onset to informed consent date
Maltese: Definita bħala l-pazjenti kollha b'dijanjożi ta' amilojdożi ta' transthyretin ereditarja b'kardjomijopatija (hATTR-CM) mad-dħul fl-istudju jew ħxuna tal-ħajt ventrikolari tax-xellug >1.3 cm fuq ekokardjogramma mingħajr storja magħrufa ta' ipertensjoni persistenti
English: Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia (see section 4.8).
Maltese: Inotersen huwa assoċjat ma' tnaqqis fl-għadd tal-pjastrini, li jista' jirriżulta fi tromboċitopenja (ara sezzjoni 4.8).
English: Acute kidney injury Renal impairment
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras Disturbi vaskulari
English: What Tegsedi looks like and contents of the pack
Maltese: Kif jidher Tegsedi u l-kontenut tal-pakkett
English: The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' inotersen fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: WARNINGS
Maltese: Kontużjoni
English: It is used to treat adults with hereditary transthyretin amyloidosis.
Maltese: Dan jintuża biex jikkura adulti b'amilojdożi ta' transthyretin ereditarja.
English: Following distribution to the patient, can be stored 6 weeks below 30°C.
Maltese: Wara d-distribuzzjoni lill-pazjent, jista' jinħażen 6 ġimgħat taħt 30 C.
English: - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia) - Headache - Vomiting, or nausea (feeling sick) - Increase in body temperature - Feeling cold (chills) or shivering - Injection site pain, redness, itching or bruising - Swelling of the ankles, feet or fingers (peripheral oedema)
Maltese: - Tnaqqis fiċ-ċelluli ħomor tad-demm li jagħmel il-ġilda pallida u jikkawża dgħufija jew qtugħ ta' nifs (anemija) - Uġigħ ta' ras - Rimettar jew nawsja (tħossok ma tiflaħx) - Żieda fit-temperatura tal-ġisem - Tħoss il-bard (dehxiet ta' bard) jew titriegħed - Uġigħ, ħmura, ħakk jew tbenġil fis-sit tal-injezzjoni - Nefħa tal-għekiesi, tas-saqajn jew tas-swaba' (edema periferali)
English: • The list of signs and symptoms of thrombocytopenia, glomerulonephritis, and ocular toxicity due to vitamin A deficiency, highlighting that these might be severe or life-threatening, and advising patients to call immediately their doctor or attend the emergency room if such signs and symptoms appear;
Maltese: • Il-lista ta' sinjali u sintomi ta' tromboċitopenija u glomerulonefrite u ta' tossiċità okulari dovuta għal nuqqas ta' vitamina A, li tenfasizza li dawn jistgħu jkunu severi jew ta' theddida għall-ħajja, u tagħti l-parir lill-pazjenti li jċemplu minnufih lit-tabib tagħhom jew li għandhom imorru f'sala tal-emerġenza hekk kif ifeġġu sinjali u sintomi bħal dawn;
English: - 1 Pre-filled syringe from the refrigerator - 1 Alcohol wipe (not supplied) - 1 Gauze pad or cotton ball (not supplied) - 1 Puncture-resistant (sharps) container (not supplied)
Maltese: - Siringa mimlija għal-lest 1 mill-friġġ - Biċċa bl-alkoħol 1 (mhux fornuta) - Garża jew tajjara 1 (mhux fornuta) - Kontenitur reżistenti għall-qtugħ 1 (ta' affarijiet jaqtgħu) (mhux fornut)
English: Patients should be monitored for signs of increased proteinuria and reduction in eGFR during treatment with inotersen (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali ta' proteinurja miżjud u tnaqqis fl-eGFR waqt kura b'inotersen (ara sezzjoni 4.4).
English: Posology
Maltese: Esinofilja
English: The recommended dose of Tegsedi is one dose of 284 mg inotersen.
Maltese: Id-doża rakkomandata ta' Tegsedi hija doża waħda ta' 284 mg inotersen.
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms consistent with vitamin A deficiency, incuding: reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening, corneal perforation.
Maltese: Huwa rrakkomandat riferiment għal valutazzjoni oftalmoloġika jekk il-pazjenti jiżviluppaw sintomi okulari li jkunu konsistenti ma' defiċjenza tal-vitamina A, inkluż: vista billejl imnaqqsa jew ma jarawx billejl, għajnejn xotti persistenti, infjammazzjoni fl-għajnejn, infjammazzjoni jew ulċerazzjoni korneali, ħxuna tal-kornea, perforazzjoni korneali.