FrancophonIA/ELRC3.0 huggingface dataset:
English: In APPROACH, the Phase 3 clinical study in patients with FCS, Waylivra reduced fasting triglycerides, total cholesterol, non-HDL cholesterol, apoC-III, apoB-48, and chylomicron triglyceride levels and increased LDL-C, HDL-C, and apoB (see Table 3).
Maltese: F'APPROACH, l-istudju kliniku ta' Fażi 3 f'pazjenti b'FCS, Waylivra naqqas il-livelli ta' trigliċeridi fl-istat sajjem, il-kolesterol totali, kolesterol mhux HDL, apoC-III, apoB-48 u trigliċeridi ta' kajlomikron u żied LDL-C, HDL-C u apoB (ara Tabella 3).
English: APPROACH-volanesorsen (Index Study Baselinea, N=14)
Maltese: APPROACH-volanesorsen (Linja Bażi tal-Istudju tal-Indiċia, N=14)
English: Placebo (N=33)
Maltese: (N=33)
English: % change from Baseline in CS16
Maltese: Bażi f'CS16
English: There is limited clinical data for patients aged 65 and over (see sections 5.1 and 5.2).
Maltese: Hemm tagħrif kliniku limitat għallpazjenti li għandhom 65 sena u aktar (ara sezzjonijiet 5.1 u 5.2).
English: Water for injections, hydrocloric acid and sodium hydroxide
Maltese: Ilma għall-injezzjonijiet, hydrochloric acid u sodium hydroxide
English: Background lipid-lowering therapies remained consistent throughout the study.
Maltese: It-terapiji flisfond li jnaqqsu l-lipidi baqgħu konsistenti tul l-istudju.
English: LS Mean Percent Change (95% CI)
Maltese: Medja f'LS (95% CI)
English: Following a dose of 285 mg once weekly in patients with FCS, the estimated geometric mean (coefficient of variation % of geometric mean) steady-state Cmax is 8.92 µg/ml (35%), AUC0-168h is 136 µg*h/ml (38%), and Ctrough is 127 ng/ml (58%) in patients who remain negative for anti-drug antibody.
Maltese: Wara doża ta' 285 mg darba fil-ġimgħa f'pazjenti b'FCS, il-medja ġeometrika stmata (koeffiċjent ta' varjazzjoni % ta' medja ġeometrika) fl-istat fiss Cmax hi ta' 8.92 µg/ml (35%), AUC0-168h hi 136 µg*h/ml (38%) u Cmin hi 127 ng/ml (58%) f'pazjenti li jibqgħu negattivi għal antikorpi antimediċinali.
English: Water for injections, hydrocloric acid and sodium hydroxide.
Maltese: Ilma għall-injezzjonijiet, hydrochloric acid u sodium hydroxide.
English: In the Phase 3 clinical studies (CS16 and APPROACH), 16% and 30% of volanesorsen-treated patients tested positive for anti-drug antibodies during 6-month and 12-month treatment, respectively.
Maltese: Fl-istudji kliniċi ta' Fażi 3 (CS16 u APPROACH), 16% u 30% ta' pazjenti ttrattati b'volanesorsen ittestjaw pożittivi għal antikorpi kontra l-mediċina waqt trattament ta' 6 xhur u 12-il xahar, rispettivament.
English: After a 6-week diet run-in period, the mean fasting triglyceride level at baseline was 2,209 mg/dL (25.0 mmol/L).
Maltese: Wara dieta ta' 6 ġimgħat bħala perijodu ta' tħejjija, il-livell ta' trigliċeridi fl-istat sajjem kien ta' 2,209 mg/dL (25.0 mmol/l).
English: Mean age was 46 years (range 20-75 years; 5 patients ≥65 years old); 45% were men; 80% were White, 17% were Asian, and 3% were of other races.
Maltese: L-età medja kienet ta' 46 sena (firxa 20-75 sena; 5 pazjenti kienu ≥65 sena); 45% kienu rġiel; 80% kienu Bojod, 17% kienu Ażjatiċi, u 3% kienu ta' razez oħra.
English: Compliance with diet and alcohol restriction was reinforced through periodic counselling sessions during the study.
Maltese: Konformità ma' restrizzjoni tad-dieta u alkoħol kienet rinforzata permezz ta' sessjonijiet perijodiċi ta' counselling waqt l-istudju.
English: Haematuria (1, 1%) Proteinuria (1, 1%)
Maltese: Ematurja (1, 1%) Proteinurja (1, 1%)
English: The selective binding of volanesorsen to the apoC-III messenger ribonucleic acid (mRNA) within the 3′ untranslated region at base position 489-508 causes the degradation of the mRNA.
Maltese: L-irbit selettiv ta' volanesorsen malmessaġġier tal-aċidu ribonukleotide (mRNA) ta' apoC-III fi ħdan ir-reġjun mhux tradott ta' 3′ fil-pożizzjoni tal-bażi 489-508 jikkaġuna id-degradazzjoni tal-mRNA.
English: Table 6: Summary of Fasting Triglycerides (Mean (SD, SEM), mg/dL) Over Time in Study CS7
Maltese: Tabella 6: Ġabra fil-Qosor għal Trigliċeridi fl-Istat Sajjem ((SD, SEM) mg/dl medju) mażŻmien fl-Istudju CS7
English: A history of documented acute pancreatitis was reported for 76% of patients and a history of diabetes was reported for 15% of patients; 21% of patients had a recorded history of lipaemia retinalis and 23% of patients had a recorded history of eruptive xanthomas.
Maltese: Storja ta' pankreatite dokumentata ġiet rapportata għal 76% tal-pazjenti u storja ta' dijabete kienet rapportata għal 15% tal-pazjenti; 21% tal-pazjenti kellhom storja dokumentata ta' lipemija retinalis u 23% tal-pazjenti kellhom storja dokumentata ta' ksantoma eruttiva.
English: In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Maltese: F'xadini individwali, tromboċitopenija severa kienet innotata fl-istudju ta' 9 xhur ta' gruppi trattati bilmediċina f'esponimenti klinikament rilevanti u ġiet osservata wkoll fi studji kliniċi.
English: How to store Waylivra 6.
Maltese: Kif taħżen Waylivra 6.
English: Waylivra with alcohol
Maltese: Waylivra ma' alkoħol
English: Pyrexia (4, 5%)
Maltese: Deni (4, 5%)
English: LS Mean % Change from Baseline
Maltese: Bidla % Linja Bażi
English: Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model) p-value from ANCOVA model < 0.0001 at Month 3 (primary efficacy endpoint), Month 6 and Month 12 Additional efficacy results for changes in triglyceride are presented in Table 5.
Maltese: Differenza = Medja f'LS ta' [Bidla % volanesorsen - Bidla % Plaċebo] (Mudell ANCOVA) valur p mill-mudell ta' ANCOVA <0.0001 fix-Xahar 3 (punt ta' effikaċja primarja), Xahar 6 u Xahar
English: In APPROACH and its open-label extension (CS7), patients discontinuing therapy due to platelet levels included 3 patients with platelet counts <25 x 109/L, 2 with platelet counts between 25 x 109/L and 50 x 109/L, and 5 with platelet counts between 50 x 109/L and 75 x 109/L.
Maltese: F'APPROACH u fl-estensjoni tiegħu bit-tikketta tingħaraf (CS7), pazjenti li ma baqgħux fuq itterapija minħabba l-livelli ta' plejtlits kienu jinkludu 3 pazjenti b'għadd ta' plejtlits <25 x 109/L, 2 b'għadd ta' plejtlits bejn 25 x 109/L u 50 x 109/L, u 5 b'għadd ta' plejtlits bejn 50 x 109/L u 75 x 109/L.
English: In the APPROACH study, the numerical incidence of pancreatitis in patients treated with volanesorsen was lower compared with placebo (3 patients 4 events in 33 placebo patients vs 1 patient 1 event in 33 volanesorsen patients).
Maltese: Fl-istudju APPROACH, l-inċidenza numerika ta' pankreatite f'pazjenti trattati b'volanesorsen kienet inqas meta mqabbla ma' plaċebo (3 pazjenti, 4 każijiet fi 33 pazjent fuq plaċebo vs pazjent 1, każ 1 fi 33 pazjent fuq volanesorsen).
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Il-frekwenza ta' reazzjonijiet avversi huma mfissra skont 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 <1/1000), rari ħafna (<1/10,000), u mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Waylivra led to a statistically significant reduction in triglyceride levels as compared to placebo at the primary efficacy endpoint, defined as percent change from baseline to Month 3 in fasting triglycerides, in addition to a lower incidence of pancreatitis over the 52-week treatment period in a post-hoc analysis (Table 4).
Maltese: Waylivra wassal għal tnaqqis statistikament sinjifikanti fil-livelli ta' trigliċeridi meta mqabbel malplaċebo fil-punt aħħari primarju t'effikaċja, imfisser bħala bidla perċentwali mil-linja bażi sa Xahar 3 ta' trigliċeridi fl-istat sajjem, minbarra inċidenza aktar baxxa ta' pankreatite fuq il-perijodu ta' 52 ġimgħa f'analiżi post-hoc (Tabella 4).
English: May be kept at room temperature for up to 6 weeks.
Maltese: Jista' jinżamm f'temperatura tal-kamra għal sa 6 ġimgħat.
English: Headache (8, 9%) Hypoaesthesia (1, 1%) Presyncope (1, 1%) Retinal migraine (1, 1%) Syncope (2, 2%) Dizziness (1, 1%) Tremor (1, 1%)
Maltese: Uġigħ ta' ras (8, 9%) Ipoaestesija (1, 1%) Presinkope (1, 1%) Emigranja retinali (1, 1%) Sinkope (2, 2%) Sturdament (1, 1%) Rogħda (1, 1%)
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ sfuż.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections.
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet.
English: b The denominator for percentage calculation was the total number of patients in FAS with baseline fasting triglyceride ≥ 750 mg/dL (or 8.5 mmol/L) in each treatment group.
Maltese: b Id-denominatur għal kalkulazzjoni perċentwali kien l-għadd totali ta' pazjenti b'FAS bi trigliċeridi fl-istat sajjem b'linja bażi ta' ≥750 mg/dL (jew 8.5 mmol/L) f'kull grupp ta' trattament.
English: Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg.
Maltese: Soluzzjoni ċara, mingħajr kulur għal kemxejn safra b'pH ta' madwar 8 u b'osmolalità ta' madwar 363485 mOsm/kg.
English: Posology
Maltese: PAKKETT
English: Do not use this medicine after the expiry date which is stated on the carton and syringe label after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta tas-siringa wara ‘EXP'.
English: At the primary efficacy endpoint, the treatment difference between volanesorsen and placebo in mean fasting triglyceride percent change was -94% (95% CI: -122% -67%; p˂0.0001, with a decrease of77% from baseline (95% CI: -97, -56) in patients receiving volanesorsen and an increase of 18% from baseline (95% CI: -4, 39) in patients receiving placebo (Table 4).
Maltese: 0001), bi tnaqqis ta' -77% mil-linja bażi (95% CI: -97, -56) f'pazjenti li jirċievu volanesorsen u b'żieda ta' 18% mil-linja bażi (95% CI: -4, 39) f'pazjenti li jirċievu plaċebo (Tabella 4).
English: In clinical studies in patients with FCS, the most commonly reported adverse reactions during treatment were platelet count decreased (see section 4.4), occurring in 40% of patients during the pivotal studies, and injection site reactions, occurring in 82% of patients.
Maltese: Fi studji kliniċi f'pazjenti b'FCS, l-aktar reazzjonijiet avversi komuni rapportati waqt it-trattament kienu tnaqqis fl-għadd ta' plejtlits (ara taqsima 4.4), li jseħħu f'40% ta' pazjenti waqt l-istudji ewlenien, u reazzjonijiet fis-sit ta' injezzjoni, li jseħħu fi 82% tal-pazjenti.
English: mg/dL -19 (-24, -15) mmol/L
Maltese: -19 (-24, -15) mmol/L -20
English: Non-HDL-C
Maltese: Mhux HDL-C
English: The APPROACH study is a randomised, double-blind placebo-controlled 52-week multicentre clinical study in 66 patients with FCS, evaluating volanesorsen 285 mg administered as a subcutaneous injection (33 treated with volanesorsen, 33 with placebo).
Maltese: L-istudju APPROACH huwa studju kliniku każwali, multiċentriku u double-blind ta' 52 ġimgħa bi plaċebo bħala kontroll f'66 pazjent b'FCS, li jevalwa 285 mg volanesorsen mogħtija bħala injezzjoni taħt il-ġilda (33 trattati b'volanesorsen, 33 bi plaċebo).
English: At study entry, 55% of patients were on lipid lowering therapies (48% on fibrates, 29% on fish oils, 20% HMG-CoA reductase inhibitors), 27% were on pain medications, 20% were on platelet aggregation inhibitors, and 14% were on nutritional supplements.
Maltese: Mad-dħul fl-istudju, 55% tal-pazjenti kienu fuq terapiji li jbaxxu l-lipidi (48% fuq fibrati, 29% fuq żjut tal-ħuta, 20% fuq impedituri ta' HMG-CoA reductase), 27% kienu fuq mediċini tal-uġigħ, 20% kienu fuq impedituri tal-aggregazzjoni tal-plejtlits, u 14% kienu fuq supplimenti nutrizzjonali.
English: Monitoring of inflammation should be assessed through quarterly assessment of erythrocyte sedimentation rate (ESR).
Maltese: Il-monitoraġġ tal-infjammazzjoni għandu jiġi assessjat permezz ta' stima trimestrali tar-rata ta' sedimentazzjoni tal-eritroċiti (ESR - erythrocyte sedimentation rate).
English: At a drug concentration 4.1 times the peak drug plasma concentrations (Cmax) of the maximum recommended dose (285 mg subcutaneous injection), volanesorsen did not prolong the heart-rate corrected QT (QTc) interval.
Maltese: Elettrofiżjoloġija Kardijaka F'konċentrazzjoni tal-mediċina 4.1 darbiet l-ogħla konċentrazzjoni fil-plażma (Cmax) tad-doża massima rakkomandata (285 mg injezzjoni taħt il-ġilda), volanesorsen ma dewwimx l-intervall QT (QTc) ikkorreġut għat-rata tal-qalb.
English: The parent drug and 5- to 7-mer chain-shortened metabolites accounted for approximately 26% and 55% of oligonucleotides recovered in urine, respectively.
Maltese: Il-mediċina oriġinali u metaboliti mqassra ta' katini b'5 sa 7 mer kienu jgħoddu għal madwar 26% u 55% ta' oligonukleotidi rkuprati fl-awrina.
English: Common (may affect up to 1 in 10 people) - Blood tests showing unusually high or low levels of white blood cells in your blood - Easy or excessive bruising, or bruising without an obvious cause - Bleeding under the skin that appears as a rash, bleeding from the gums or mouth, blood in the urine or stools, nosebleed, or unusually heavy menstrual period - An allergic reaction, the symptoms of which include skin rash, joint stiffness or fever - Blood or protein in the urine - Changes to the results of some blood tests, including: o an increase in the level of some constituents in your blood: creatinine, urea, transaminases, liver enzymes o an increase in blood clotting time o a fall in levels of haemoglobin in your blood o a fall in the rate of blood passing through the kidneys - Diabetes, the symptoms of which include increased thirst, frequent need to pass urine (particularly ar night), extreme hunger, severe tiredness, and unexplained weight loss - Difficulty sleeping - Headaches, numbness, tingling or pins and needles, feeling faint or fainting, dizziness or shaking - Visual disturbances, such as flashing lights or brief, temporary blindness in one eye, bleeding under the surface of the eye, or blurred vision - High blood pressure - Hot flush, increased sweating, night sweats, chills, feeling hot, pain, flu-like illness or a general feeling of being unwell - Cough, difficulty breathing, a blocked nose, swelling of the throat, wheezing - Feeling or being sick, dry mouth, diarrhoea, swelling of the neck, face or gums, stomach pain or swelling, indigestion - Skin redness, rash, pimples, thickening or scarring, or itchiness of the skin known as ‘hives' (urticaria) - Muscle pain, pain in the hands or feet, joint pain or stiffness, back pain, neck pain, jaw pain, muscle spasms, or other body pains
Maltese: Il-pazjeti għandhom jingħataw struzzjonijiet biex jirraportaw lit-tabib tagħhom minnufih jekk jesperjenzaw xi sinjali ta' emorraġija li jistgħu jinkludu petekkje, tbenġil spontanju, emorraġija taħt ilkonġuntiva, jew emorraġija oħra mhux tas-soltu (li jinkludu mnieħer jinfaġar, fsada fil-ħanek, flippurgar u ċiklu menstruwali eċċessiv u mhux tas-soltu), ebusija tal-għonq, uġigħ ta' ras qawwi u atipiku, jew kull emorraġija fit-tul.
English: Pause treatment for ≥4 weeks and resume treatment after platelet levels ≥ 100 x 109/L
Maltese: Irrinvija t-trattament għal ≥4 ġimgħat u kompli t-trattament wara li l-livelli ta' plejtlits >100 x 109/L
English: Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Maltese: Waylivra hu indikat bħala aġġunt għad-dieta f'pazjenti adulti bis-sindrome familjali ta' kajlomikronemija (FCS - familial chylomicronemia syndrome) ikkonfermat ġenetikament u b'riskju għoli għal pankreatite, li għalihom rispons għad-dieta u terapija li tbaxxi t-trigliċeridi kienet inadegwata.
English: Triglycerides Total Cholesterol
Maltese: Kolesterol Totali LDL-C
English: Waylivra is very commonly associated with reductions in platelet count in patients with FCS, which may result in thrombocytopenia (see section 4.8).
Maltese: Waylivra huwa assoċjat b'mod komuni ħafna ma' tnaqqis fl-għadd ta' plejtlits f'pazjenti b'FCS, li jista' jirriżulta fi tromboċitopenija (ara sezzjoni 4.8).
English: It is normal to see a large air bubble (Figure D).
Maltese: Huwa normali li tara bużżieqa kbira tal-arja (Stampa D).
English: Contents of the pack and other information What Waylivra contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Waylivra
English: It is important to tell your doctor if you are already being treated with any of the following: - Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamol or warfarin.
Maltese: - Mediċini li jevitaw l-emboli tad-demm, eż. acetylsalicylic acid, dipyridamol jew warfarin.
English: Waylivra can be stored at room temperature (8 °C-30 °C), in the outer carton to protect from light, for up to 6 weeks.
Maltese: Waylivra jista' jinżamm fit-temperatura tal-kamra (8 °C-30 °C) fil-kartuna ta' barra sabiex tipproteġi mid-dawl għal 6 ġimgħat.
English: Asthenia (8, 9%) Fatigue (8, 9%)
Maltese: Astenja (8, 9%)
English: Percent of patientsb with fasting plasma triglyceride < 750 mg/dL (8.5 mmol/L)*
Maltese: <750 mg/dL (8.5 mmol//L)*
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels <75 x 109/L and treatment with these medicinal products should be stopped at platelet levels < 50 x 109/L (see section 4.4).
Maltese: It-twaqqif ta' prodotti mediċinali li jaġixxu kontra l-plejtlits/NSAIDs/antikoagulanti għandu jiġu kkonsidrat għal livelli ta' plejtlits <75 x 109/L u trattament b'dawn il-prodotti mediċinali għandu jitwaqqaf f'livelli ta' plejtlits <50 x 109/L (ara sezzjoni 4.4).
English: In the pivotal Phase 3 study in patients with FCS (the APPROACH study), confirmed reductions in platelet counts to below normal (140 x 109/L) were observed in 75% of FCS patients treated with volanesorsen and 24% of placebo patients; confirmed reductions to below 100 x 109/L were observed in 47% of patients treated with volanesorsen compared with no placebo patients.
Maltese: Fl-istudju ewlieni ta' Fażi 3 f'pazjenti b'FCS (l-istudju APPROACH), tnaqqis ikkonfermat fl-għadd ta' plejtlits għal taħt il-livell tan-normal (140 x 109/L) kien osservat f'75% tal-pazjenti b'FCS ittrattati b'volanesorsen u 24% ta' pazjenti fuq plaċebo; tnaqqis ikkonfermat għal taħt 100 x 109/L kien osservat f'47% ta' pazjenti ttrattati b'volanesorsen meta mqabbla ma' ebda pazjent fuq plaċebo.
English: Observed Value change from Baseline in CS7 n
Maltese: Bażi f'CS7 n
English: Both volanesorsen and shorter oligonucleotide metabolites (predominantly 7-mer metabolites (generated either from 3′-deletions or 5′-deletions))
Maltese: Kemm volanesorsen u metaboliti oligonukleotidi mqassra (prinċipalment metaboliti ta' 7-mer (iġġenerati jew minn 3′-deletions jew 5′-deletions)) kienu identifikati fl-awrina tal-bniedem.
English: Dose (285 mg prefilled syringe)
Maltese: Doża (285 mg siringa mimlija għal lest)
English: Table 3: Mean Baseline and Percent Change in Lipid Parameters from Baseline to Month 3
Maltese: Tabella 3: Linja Bażi Medja u Bidla Perċentwali fil-Parametri ta' Lipidi mil-Linja
English: Prior to launch of Waylivra in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Tqegħid fis-Suq (MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, inkluż ilmezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm,
English: Immunogenicity and inflammation
Maltese: Immunoġeniċità u infjammazzjoni
English: Careful monitoring for thrombocytopenia is important during treatment with this medicinal product in patients with FCS (see section 4.2).
Maltese: Monitoraġġ attent għal tromboċitopenija huwa importanti waqt it-trattament b'dan il-prodott mediċinali f'pazjenti b'FCS (ara sezzjoni 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK WITH BLUE BOX
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA - PAKKETT MULTIPLU B'KAXXA BLU
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels < 75 x 109/L.
Maltese: Il-waqfien ta' prodotti mediċinali li jaġixxu kontra l-plejtlits/NSAIDs/antikoagulanti għandu jiġi kkonsidrat għal-livelli ta' plejtlits <75 x 109/L.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu.
English: Leukopenia (2, 2%) Eosinophilia (1, 1%) Immune thrombocytopenic purpura (1, 1%)
Maltese: Eożinofilja (1, 1%) Purpura tromboċitopenika immuni (1, 1%) Tbenġil spontanju (1, 1%)
English: Each single-dose pre-filled syringe contains 285 mg of volanesorsen in 1.5 ml solution.
Maltese: Kull siringa mimlija għal-lest b'doża unika fiha 285 mg volanesorsen f'1.5 ml ta' soluzzjoni.
English: Package leaflet: Information for the user Waylivra 285 mg solution for injection in pre-filled syringe volanesorsen ▼This medicine is subject to additional monitoring.
Maltese: Informazzjoni għall-utent Waylivra 285 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest volanesorsen ▼ Dan il-prodott mediċinali hu suġġett għal monitoraġġ addizzjonali.
English: Volanesorsen is not a substrate for CYP metabolism, and is metabolised in tissues by endonucleases to form shorter oligonucleotides that are then substrates for additional metabolism by exonucleases.
Maltese: Volanesorsen mhux substrat għal metaboliżmu CYP, u huwa metabolizzat f'tessuti b'endocucleases biex jifforma oligonukleotidi li mbagħad huma substrati għal metaboliżmu addizzjonali b'exonucleases.
English: The decrease in platelet counts was not acute and decreased to below 50,000 cells/μl.
Maltese: It-tnaqqis fl-għadd tal-plejtlits ma kienx akut u t-tnaqqis niżel taħt 50,000 ċellola/μl.
English: - Other medicines that may change how your blood clots, including non-steroidal antiinflammatory medicines like ibuprofen, medicines used to prevent heart attacks and strokes such as clopidogrel, ticagrelor and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce stomach acid), and quinine (used to treat malaria).
Maltese: - Mediċini oħra li jistgħu jibdlu kif id-demm tiegħek jagħqad, li jinkludu mediċini anti infjammatorji mhux sterojdi bħal ibuprofen, mediċini użati biex jevitaw l-attakki tal-qalb u puplesiji bħal clopidogrel, ticagrelor u prasugrel, antibijotiċi bħal penicillin, mediċini bħal ranitidine (użat biex inaqqas l-aċidu fl-istonku) u quinine (użat biex jikkura l-malarja).
English: Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS).
Maltese: Waylivra fih is-sustanza attiva volanesorsen, li tgħin biex tittratta l-kundizzjoni magħrufa bħala sindrome familjali ta' kajlomikronemija (FCS, familial chylomicronemia syndrome).
English: The median age at diagnosis was 27 years, with 23% shown to lack a known FCS genetic mutation.
Maltese: L-età medjana ta' dijanjosi kienet ta' 27 sena, bi 23% murija li m'għandhomx mutazzjoni ġenetika magħrufa għal FCS.
English: With treatment with Waylivra, LDL-C levels may rise but will usually remain within the normal range.
Maltese: Bi trattament b'Waylivra, il-livelli ta' LDL-C jistgħu jogħlew imma ġeneralment ser jibqgħu fi ħdan il-firxa normali.