FrancophonIA/ELRC3.0 huggingface dataset:
English: Single- and multiple-dose pharmacokinetics of volanesorsen in healthy volunteers and patients with hypertriglyceridemia have shown that the Cmax of volanesorsen is dose-proportional over a dose range of 100 to 400 mg and the AUC is slightly more than dose-proportional over the same dose range.
Maltese: Farmakokinetiċi b'doża waħda jew multipla ta' volanesorsen f'voluntieri b'saħħithom u pazjenti b'ipertrigliċeridemija wrew li s-Cmax ta' volanesorsen huwa proporzjonali mad-doża fuq firxa wiesgħa ta' 100 sa 400 mg u l-AUC huwa ftit aktar minn dak proporzjonali għad-doża fuq l-istess firxa dożali.
English: Other medicines and Waylivra
Maltese: Mediċini oħra u Waylivra
English: Dose and time-dependent reductions in platelet counts were observed in Cynomolgus monkey repeated dose studies.
Maltese: Id-doża u t-tnaqqis dipendenti maż-żmien fl-għadd ta' plejtlits kienu osservati f'xadini Cynomolgus fi studji f'doża ripetuta.
English: Anti-volanesorsen antibody formation affecting pharmacokinetics The formation of binding antibodies to volanesorsen appeared to increase total Ctrough by 2- to 19-fold.
Maltese: Formazzjoni ta' antikorpi anti-volanesorsen li jaffettwaw il-farmakokinetiċi Il-formazzjoni ta' antikorpi li jintrabtu ma' volanesorsen dehru li żiedu it-total ta' Cmin b'2 sa 19-il darba.
English: Chylomicron Triglycerides 20
Maltese: SIRINGA MIMLIJA GĦAL-LEST
English: Diagnosis of FCS required documentation of at least one of the following: a) Confirmed homozygote, compound heterozygote, or double heterozygote for known loss-offunction mutations in Type 1-causing genes (such as LPL, APOC2, GPIHBP1, or LMF1)
Maltese: Dijanjosi ta' FCS kien jeħtieġ dokumentazzjoni ta' mill-inqas wieħed minn dawn li ġejjin: a) Omożigota konfermat, eterożigota kompost jew eterożigota doppju għal mutazzjonijiet magħrufin għal telf ta' funzjoni f'ġeni kawżanti tat-Tip 1 (bħal LPL, APOC2, GPIHBP1 jew LMF1) b) Attività ta' LPL fil-plażma wara l-eparina ta' ≤20% tan-normal.
English: An alternative dosing regimen of 285 mg volanesorsen every two weeks results in a Ctrough,ss of approximately 58.0 ng/ml with Cmax and AUC similar compared to the once weekly dosing regimen.
Maltese: Kors ta' dożaġġ alternattiv ta' 285 mg volanesorsen kull ġimagħtejn jirriżulta f'Cmin fi stadju fiss ta' madwar 58.0 ng/ml b'Cmax u AUC simili meta mqabbel ma' kors ta' dożaġġ ta' darba fil ġimgħa.
English: Treatment-naïve Group (Open-label Study Baselinea, N=51)
Maltese: Grupp ta' Pazjenti li ma Kinux Ħadu Kura Qabel (Linja Bażi tal-Istudju bit-Tikketta Tingħarafa, N=51)
English: As a precautionary measure, it is preferable to avoid the use of this medicinal product during pregnancy.
Maltese: Bħala miżura prekawzjonarja, huwa preferibbli li jiġi evitat l-użu ta' dan il-prodott mediċinali waqt it-tqala.
English: Almac Pharma Services Ireland Ltd. Finnabair Industrial Estate Dundalk
Maltese: Almac Pharma Services Ireland Ltd.
English: It is filled to deliver 1.5 ml of solution upon full depression of the syringe's plunger.
Maltese: Hija mimlija biex tforni 1.5 ml ta' soluzzjoni mad-depressjoni sħiħa tal-planġer tas-siringa.
English: Treatment should not be initiated in patients with thrombocytopenia (platelet count <140 x 109/L).
Maltese: plejtlits fid-demm (inqas minn 140 x 109/L).
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: Silġ/Pakkett tas-silġ
English: Main inclusion criteria were a diagnosis of FCS (Type 1 hyperlipoproteinemia) in combination with a history of chylomicronemia evidenced by documentation of lactescent serum or documentation of fasting TG measurement ≥ 880 mg/dl.
Maltese: Il-kriterji ewlenien fl-inklużjoni kienu dijanjosi ta' FCS (iperproteinemija ta' Tip 1) f'kombinazzjoni ma' storja ta' kajlomikronemija bid-dokumentazzjoni bħala evidenza ta' serum li jidher qisu ħalib jew dokumentazzjoni ta' kejl ta' TG fl-istat sajjem ≥880 mg/dl.
English: Clinical studies included 4 patients with FCS aged 65 treated with volanesorsen in randomised control studies (phase II study CS2, 1 patient; APPROACH 3 patients), and 6 patients aged 65 and over in the open-label extension study (CS7).
Maltese: II, pazjent 1; APPROACH 3 pazjenti), u 6 pazjenti li għandhom 65 sena u aktar fl-istudju ta' estensjoni bit-tikketta tingħaraf (CS7).
English: Solution for injection in pre-filled syringe Multipack: 4 (4 packs of 1) pre-filled syringes
Maltese: Pakkett multiplu: 4 (4 pakketti ta' 1) siringi mimlija għal-lest
English: Waylivra can be kept at room temperature (up to 30 °C) in the original carton for up to 6 weeks after removing from the refrigerator.
Maltese: Waylivra jista' jinżamm fit-temperatura tal-kamra (sa 30 °C) fil-kartuna oriġinali u sa 6 ġimgħat wara li jkun tneħħa minn ġol-friġġ.
English: Waylivra has not been studied in patients under 18 years old.
Maltese: Waylivra ma ġiex studjat f'pazjenti li għadhom m'għalqux it-18-il sena.
English: - Medicines that may cause problems with your liver, such as paracetamol.
Maltese: - Mediċini li jistgħu jikkawżaw problemi bil-fwied tiegħek, bħal paracetamol.
English: P-values from logistic regression model with treatment, presence of pancreatitis and presence of concurrent omega-3 fatty acids and/or fibrates as factors, and logarithm-transformed baseline fasting triglycerides as a covariate.
Maltese: 0001 Valuri p b'mudell ta' rigressjoni loġistika bi trattament, preżenza ta' pankreatite u l-preżenza ta' aċidi grassi ta' omega-3 u/jew fibrati bħala fatturi, u trigliċeridi fl-istat sajjem transformati għal logaritmi fil-linja bażi bħala kovarjant.
English: Breastfeeding
Maltese: Trigliċeridi
English: Nausea (8, 9%) Diarrhoea (4, 5%) Dry mouth (1,1 %)
Maltese: Dardir (8, 9%) Dijarea (4, 5%) Ħalq xott (1, 1%)
English: Monitoring for hepatotoxicity through serum liver enzymes and bilirubin should be assessed on a quarterly basis.
Maltese: Monitoraġġ ta' epatotossiċità permezz tal-enzimi tal-fwied fis-serum u bilirubina għandhom jiġu assessjati fuq bażi trimestrali.
English: Single-dose, Type I glass pre-filled syringe with a siliconised chlorobutyl rubber stopper and staked needle with shield, filled to deliver 1.5 ml of solution.
Maltese: Siringa mimlija għal-lest fi ħġieġ ta' Tip 1 b'tapp tal-lastku tal-chlorobutyl silikonizzat u għatu tal-labra, mimlija biex tagħti 1.5 ml ta' soluzzjoni.
English: Diabetes mellitus (1, 1%)
Maltese: Dijabete mellitus (1, 1%)
English: Injection site haematoma (7, 8%) Injection site reaction (6, 7%) Injection site urticaria (5, 6%) Injection site warmth (5, 6%) Chills (5, 6%)
Maltese: Ematoma fis-sit tal-injezzjoni (7, Reazzjoni fis-sit tal-injezzjoni (6, Urtikarja fis-sit tal-injezzjoni (5, Sħana fis-sit tal-injezzjoni (5, Sirdat (5, 6%)
English: The decrease was gradual, self-sustaining and did not decrease to adverse levels.
Maltese: It-tnaqqis kien gradwali, awtosostenibbli u ma naqqasx għal-livelli avversi.
English: - Injection site reactions (pain, redness, heat, dryness, swelling, itching, tingling, hardening, pimpling, bruising, bleeding, numbness, change in colour or a burning feeling at the injection site).
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 f'10) - Reazzjonijiet f'siti tal-injezzjoni (uġigħ, ħmura, sħana, nixfa, nefħa, ħakk, tinġiż, ebusija, formazzjoni ta' nuffat, tbenġil, emorraġija, tnemnim, bidla fil-kulur jew sensazzjoni ta' ħruq fis-sit ta' injezzjoni).
English: Insomnia (1, 1%)
Maltese: Emorraġija (1, 1%)
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji tal-annimali ma jindikawx effetti diretti jew indiretti li jistgħu jagħmlu ħsara fir-rigward ta' tossiċità riproduttiva (ara sezzjoni 5.3).
English: Monitoring Frequency
Maltese: Frekwenza ta'
English: Baselinea Month 3
Maltese: ANNESS II
English: • Made of heavy-duty plastic,
Maltese: • Magħmul minn plastik robust.
English: It is available as either a carton containing 1 pre-filled syringe, or as a multipack of 4 (4 packs of 1-pack cartons) pre-filled syringes.
Maltese: Huwa disponibbli jew bħala kartuna li fiha siringa 1 mimlija għal-lest, jew bħala pakkett multiplu ta' 4 (4 pakketti ta' kartuna f'pakkett 1) siringi mimlijin għal-lest.
English: mg/dL -20 (-26, -15) mmol/L
Maltese: (-26, -15) mmol/L
English: Haematoma (3, 3%) Hypertension (1, 1%) Haemorrhage (1, 1%) Hot flush (1, 1%)
Maltese: Ematoma (3, 3%) Pressjoni għolja (1, 1%)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 285 mg, that is to say it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodju (23 mg) f'kull doża jew 285 mg, jiġifieri huwa essenzjalment ‘ħieles mis-sodju'.
English: However, treatment should be discontinued in patients with a reduction in serum triglycerides <25% or who fail to achieve serum triglycerides below 22.6 mmol/L after 3 months on volanesorsen 285 mg weekly.
Maltese: Madanakollu, it-trattament għandu jitwaqqaf f'pazjenti bi tnaqqis ta' trigliċeridi fis-serum <25% jew li jfallu li jilħqu livell ta' trigliċeridi fis-serum ta' inqas minn 22.6 mmol/L wara 3 xhur fuq volanesorsen 285 mg kull ġimgħa.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodju'.
English: Remove needle cap
Maltese: UŻATI JEW SKART MINN DAWN
English: It is important that you maintain this triglyceride-lowering diet whilst using Waylivra.
Maltese: Huwa importanti li żżomm din id-dieta li tbaxxi t-trigliċeridi waqt li qed tuża Waylivra.
English: Chronic or unexplained thrombocytopenia.
Maltese: - Diffikultà biex torqod.
English: Percent of patientsc with ≥ 40% reduction in fasting triglycerides** a The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Maltese: Il-punt aħħari ta' Xahar 3 kien definit bħala l-medja tal-evalwazzjoni fl-istat sajjem ta' Ġimgħa 12 (Jum 78) u Ġimgħa 13 (Jum 85).
English: Daily a See section 4.4 for recommendations regarding use of antiplatelet agents/NSAIDs/anticoagulants b Consultation of a haematologist is needed to reconsider the benefit/risk for possible further treatment with volanesorsen.
Maltese: Kuljum a Ara sezzjoni 4.4 għal rakkomandazzjonijiet rigward l-aġenti antiplejtlits/NSAIDs/antikoagulanti.
English: Figure 1: LS Mean Percent Change in Fasting Triglycerides in Phase 3 Study in Patients with FCS (APPROACH)
Maltese: Figura 1: Bidla Perċentwali Medja f'LS ta' Trigliċeridi fl-Istat Sajjem fl-Istudju ta' Fażi 3 f'Pazjenti b'FCS (APPROACH)
English: Epistaxis (3, 3%) Cough (1, 1%) Dyspnoea (2, 2%) Nasal congestion (1, 1%) Pharyngeal oedema (1, 1%) Wheezing (1, 1%)
Maltese: Epistassi (3, 3%) Sogħla (1, 1%) Dispnea (2, 2%)
English: The medicinal product is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment.
Maltese: Il-prodott mediċinali mhux metabolizzat permezz tas-sistema tal-enzimi ta' ċitoktom P450 fil-fwied, għalhekk laġġustament fid-doża x'aktarx mhux meħtieġ f'pazjenti b'indeboliment tal-fwied.
English: Spontaneous haematoma (1, 1%)
Maltese: Edema farinġeali (1, 1%)
English: Gingival bleeding (1, 1%) Mouth haemorrhage (1, 1%) Parotid gland enlargement (1, 1%) Vomiting (4, 5%) Abdominal pain (4, 5%) Abdominal distension (1, 1%) Dyspepsia (1, 1%) Gingival swelling (1, 1%)
Maltese: Remettar (4, 5%) Uġigħ addominali (4, 5%) Distensjoni abdominali (1, 1%) Dispepsja (1, 1%)
English: Elimination involves both metabolism in tissues and excretion in urine.
Maltese: L-eliminazzjoni jinvolvi kemm il-metaboliżmu fit-tessuti u l-eliminazzjoni fl-awrina.
English: • The Patient/carer guide shall contain the following key messages: o Relevant information on thrombocytopaenia and severe bleeding o Importance of monitoring platelet levels o Possible need for dose adjustments or treatment pauses based on platelet test results o Need to be aware of and alert to the signs of thrombocytopaenia and the importance of seeking immediate assistance from a health professional o Information about the FCS disease registry and the PASS study and encouragement to participate in those studies.
Maltese: • Il-Gwida għall-pazjent/dawk li jieħdu ħsiebu għandu jkun fiha dawn il-messaġġi ewlenin: o Informazzjoni relevanti dwar tromboċitopenija u fsada severa o L-importanza tal-monitoraġġ tal-livell tal-plejtlits o Il-possibbiltà ta' ħtieġa ta' aġġustamenti fid-doża jew pawżi fit-trattament ibbażati fuq ir-riżultati tat-testijiet tal-plejtlits o Il-bżonn li jkunu konxji u attenti għal sinjali ta' tromboċitopenija u l-importanza li jfittxu assistenza immedjata mingħand professjonist fil-qasam tal-kura tas-saħħa o Informazzjoni dwar ir-reġistru tal-marda ta' FCS u l-istudju PASS u l-importanza li jikkontribwixxu lejn dawk l-istudji o Rappurtaġġ ta' kwalunkwe reazzjoni avversa tal-mediċina lil professjonist fil-qasam tal kura tas-saħħa.
English: Baseline
Maltese: Bittija
English: Treatment with these medicinal products must be discontinued at platelet levels < 50 x 109/L (see section 4.5).
Maltese: It-trattament b'dawn il-prodotti mediċinali għandu jitwaqqaf jekk il-livelli tal-plejtlits ikun <50 x 109/L (ara sezzjoni 4.5).
English: The percent change in fasting TG from Index Study Baseline to Open-label Month 3 for the APPROACH- and CS16-volanesorsen patients was -49.2% and -64.9%, respectively.
Maltese: Il-bidla perċentwali f'TG fl-istat sajjem mill-Istudju tal-Indiċi tal-Linja Bażi għall-Istudju bit-Tikketta Tingħaraf fix-Xahar 3 għallpazjenti f'APPROACH u CS16 fuq volanesorsen kienet ta' -49.2% u -64.9% rispettivament.
English: Onset of the reduction was rapid with separation from placebo seen as early as 4 weeks and maximum response seen at 12 weeks, with clinically and statistically significant triglyceride reduction maintained over 52 weeks (Figure 1).
Maltese: Il-bidu tat-tnaqqis kien mgħaġġel b'separazzjoni mill-plaċebo muri kmieni minn 4 ġimgħat u rispons massimu muri fit-12-il ġimgħa, bi tnaqqis kliniku u statistikament sinjifikanti ta' trigleriċidi miżmum fuq 52 ġimgħa (Figura 1).
English: This medicine is intended for patients aged 18 years and above.
Maltese: Din il-mediċina hija maħsuba għal pazjenti li għalqu t-18-il sena u aktar.
English: Injecting 6.
Maltese: Kif tinjetta 6.
English: Thighs - Front, middle area as shown (Figure E).
Maltese: Koxox - Quddiem, żona tan-nofs kif muri (Stampa E).
English: Recommendations for adjustments to monitoring frequency and dosing are specified in Table 1 (see section 4.2).
Maltese: Rakkomandazzjonijiet għal aġġustamenti filfrekwenza ta' monitoraġġ u dożaġġ huma speċifikati f'Tabella 1 (ara sezzjoni 4.2).
English: mg/dL (26.5 μmol/L) that is >ULN is recorded, or creatinine clearance estimated by the CKD-EPI equation is ≤ 30 mL/min/1.73m2.
Maltese: It-trattament għandu jitwaqqaf jekk: il-proteinurja tkun reġistrata hi ta' ≥500 mg/24 siegħa, jew tkun reġistrata żieda tal-kreatinina fis serum ta' ≥0.3 mg/dL (26.5 μmol/L) li hija >il-limitu ta' fuq tan-normal, jew it-tneħħija ta' kreatinina stmata mill-ekwazzjoni CKD-EPI hi ta' ≤30 mL/min/1.73 m2.
English: Volanesorsen is an antisense oligonucleotide designed to inhibit the formation of apoC-III, a protein that is recognised to regulate both triglyceride metabolism and hepatic clearance of chylomicrons and other triglyceride-rich lipoproteins.
Maltese: Volanesorsen huwa oligonuklieotide antisens maħsub biex jimpedixxi l-formazzjoni ta' apoC-III, proteina li hi rikonoxxuta li tirregola kemm il-metaboliżmu ta' trigliċeridi u t-tneħħija mill-fwied ta' kajlomikroni u lipoproteini oħrajn arrikiti bi trigliċeridi.
English: Haemoglobin decreased (1, 1%) Hepatic enzyme increased (1, 1%) International normalised ratio increased (1, 1%)
Maltese: Tnaqqis fl-għadd ta' ċelloli bojod tad-demm (1, 1%) Tnaqqis fl-emoglobina (1, 1%) Żieda fl-enzimi tal-fwied (1, 1%) Żieda fil-Proporzon normalizzat internazzjonali (INR, international normalized ratio)
English: Renal toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: In the placebo group, of the 4 patients who had 17 adjudicated pancreatitis attacks in the prior 5 years, 3 patients experienced 4 pancreatitis attacks during the 52-week treatment period.
Maltese: Fil-grupp tal-plaċebo, mill-4 pazjenti li kellhom 17-il attakk aġġudikat ta' pankreatite fil-5 snin ta' qabel, 3 pazjenti esperjenzaw 4 attakki ta' pankreatite matul it-52 ġimgħa ta' trattament.
English: • Physician educational material
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Patients with lower body weight (less than 70 kg) may be more prone to thrombocytopenia during treatment with this medicinal product.
Maltese: Pazjenti li għandhom piż tal-ġisem aktar baxx (inqas minn 70 kg) jistgħu jkunu suxxetibbli aktar għal tromboċitopenija waqt it-trattament b'dan ilprodott mediċinali.
English: It is normal to see a large air bubble.
Maltese: Huwa normali li tara bużżieqa kbira tal-arja.
English: FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood.
Maltese: FCS hija marda ġenetika li twassal għal livelli abnormali għoljien ta' xaħmijiet msejħa trigliċeridi fid-demm.
English: Injection site vesicles (3, 3%) Malaise (2, 2%)
Maltese: Uġigħ fl-estremitajiet (5, 6%) Artrite (2, 2%)
English: Renal toxicity has been observed after administration of volanesorsen and other subcutaneously and intravenously administered antisense oligonucleotides.
Maltese: Tossiċità tal-kliewi Tossiċità tal-kliewi ġiet osservata wara l-għoti ta' volanesorsen u oligonukleotidi antisens oħrajn mogħtija taħt il-ġilda u ġol-vini.
English: LS Mean Absolute Change (95% CI) mg/dL or mmol/L
Maltese: CI) mg/dL jew mmol/L
English: Accumulation in Ctrough was observed (7- to 14-fold) and little or no increase in Cmax or AUC was observed following weekly SC administration over a dose of 200 to 400 mg.
Maltese: L-akkumulazzjoni f'Cmin kienet osservata (7 għal 14-il darba) u ma ġiet osservata l-ebda żieda jew kemxejn f'Cmax jew fl-AUC wara lgħoti taħt il-ġilda darba fil-ġimgħa fuq il-firxa dożali ta' 200 sa 400 mg.
English: Do not freeze the Waylivra pre-filled syringe.
Maltese: - Demm jew proteina fl-awrina.
English: o Relevant information on thrombocytopaenia and severe bleeding o Details of the population at higher risk for thrombocytopaenia and bleeding (e.g. those with weight less than 70 kg), and patients for which Waylivra is contraindicated (i.e. patients with chronic or unexplained thrombocytopaenia)
Maltese: o Informazzjoni relevanti dwar tromboċitopenija u fsada severa o Dettalji dwar il-popolazzjoni f'riskji ogħla ta' tromboċitopenija u fsada (eż. dawk li jiżnu inqas minn 70 kg), u pazjenti li għalihom Waylivra huwa kontraindikat (i.e. pazjenti bi tromboċitopenija kronika jew mhux spjegata) o Rakkomandazzjonijiet dwar il-monitoraġġ tal-plejtlits inkluż rakkomandazzjonijiet dwar l-aġġustament tad-doża, kemm qabel kif ukoll matul it-trattament.
English: Most patients receiving volanesorsen experienced a clinically significant reduction in triglycerides.
Maltese: Il-maġġoranza tal-pazjenti li rċivew volanesorsen esperjenzaw tnaqqis klinikament sinjifikanti fit trigliċeridi.
English: Monitoring for evidence of nephrotoxicity by routine urine dipstick is recommended on a quarterly basis.
Maltese: Monitoraġġ għal evidenza ta' nefrotossiċità b'testijiet ta' rutina bl istikka tal-awrina hu rakkomandat fuq bażi trimestrali.
English: The estimated steady-state volume of distribution (Vss) in patients with FCS is 330 L. Volanesorsen is highly bound to human plasma proteins (>98%) and the binding is concentration independent.
Maltese: Volanesorsen huwa marbut ħafna ma' proteini fil-plażma tal-bniedem (>98%) u l-irbit ma jiddependix mill-konċentrazzjoni.
English: This binding prevents translation of the protein apoC-III, thus removing an inhibitor of triglyceride clearance and enabling metabolism through an LPL-independent pathway.
Maltese: Dan l-irbit jevita t-traduzzjoni tal-proteina apoC-III, b'hekk ineħħi impeditur tat-tneħħija ta' trigliċeridi u jippermetti l-metaboliżmu permezz ta' rotta indipendenti mil-LPL.
English: - you are allergic to volanesorsen or any of the other ingredients in this medicine (listed in section 6).
Maltese: - inti allerġiku għal volanesorsen jew għal xi sustanza oħra ta' din il-mediċina (elenkati f'sezzjoni 6).
English: Subcutaneous use.
Maltese: mal-Awtorità Kompetenti Nazzjonali.
English: Based on the population pharmacokinetic analysis, age, body weight, sex, or race has no clinically relevant effect on volanesorsen exposure.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, l-età, il-piż tal-ġisem, is-sess jew ir-razza m'għandhomx effett kliniku fuq l-esponiment ta' volanesorsen.
English: Look at the liquid in the syringe.
Maltese: Osserva l-likwidu fis-siringa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with volanesorsen in one or more subsets of the paediatric population in the treatment of familial chylomicronemia syndrome (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'volanesorsen f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fit-trattament ta' sindrome familjali ta' kajlomikronemija (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Pack sizes of one pre-filled syringe or multipacks containing 4 (4 packs of 1) pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' siringa waħda mimlija għal-lest jew pakketti multipli ta' 4 (4 pakketti ta' 1) siringi mimlijin għal-lest.
English: Patients should be re-downtitrated to 285 mg every 2 weeks if the higher 285 mg once weekly dose does not provide significant additional triglyceride reduction after 9 months.
Maltese: Il-pazjenti għandhom jiġu tittrati 'l isfel mill-ġdid għal 285 mg kull ġimgħatejn jekk id-doża ta' darba fil-ġimgħa ta' 285 mg ma tipprovdix tnaqqis addizzjonali sinjifikanti ta' trigliċeridi wara 9 xhur.
English: • Periodic safety update reports
Maltese: • Pakkett ta' informazzjoni għall-Pazjent
English: Each single-use, prefilled syringe of this medicine gives you a dose of 285 mg in 1.5 ml.
Maltese: Kull użu singolari, bis-siringa mimlija għal-lest ta' din il-mediċina tkun qed tagħti doża ta' 285 mg f'1.5 ml.
English: Injury, poisoning and procedural complications
Maltese: Feriment, Avvelenament u komplikazzjonijiet ta' xi proċedura
English: Non-cardiac chest pain (1, 1%) Vessel puncture site haemorrhage
Maltese: Uġigħ fis-sider mhux kardijaku Emorraġija fis-sit ta' titqib talvażi (1, 1%)
English: Injection site mass (2, 2%) Pain (2, 2%)
Maltese: Uġigħ fid-dahar (2, 2%) Uġigħ muskoloskeletriku (2, 2%)
English: Blood urea increased (1, 1%) Creatinine renal clearance decreased (1, 1%) Transaminases increased (1, 1%) White blood cell count decreased
Maltese: Żieda fl-urea fid-demm (1, 1%) Tnaqqis fit-tneħħija ta' kreatinina mill-kliewi (1, 1%) Żieda fit-transaminases (1, 1%)
English: The recommended starting dose is 285 mg in 1.5 ml injected subcutaneously once weekly for 3 months.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 285 mg f'1.5 ml injettati taħt il-ġilda darba fil-ġimgħa għal 3 xhur.
English: Injection site erythema (67, 78%) Injection site pain (38, 44%) Injection site pallor (37, 43%) Injection site swelling (25, 29%) Injection site pruritus (22, 26%) Injection site discolouration (19,
Maltese: Eritema fis-sit tal-injezzjoni (67, Uġigħ fis-sit tal-injezzjoni (38, Sfurija fis-sit tal-injezzjoni (37, Nefħa fis-sit tal-injezzjoni (25, Ħakk fis-sit tal-injezzjoni (22, Bdil fil-kulur fis-sit tal-injezzjoni Ebusija fis-sit tal-injezzjoni (17, Tbenġil fis-sit tal-injezzjoni (10, Edema fis-sit tal-injezzjoni (10,