FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
Maltese: Fi studji kliniċi, kompressjoni tal-korda spinali/ċervikali (SCC - spinal/cervical cord) kienet osservata kemm f'pazjenti li kienu qed jirċievu Vimizim kif ukoll f'pazjenti li kienu qed jirċievu plaċebo.
English: Because this is a protein solution, slight flocculation (thin translucent fibres) may occur.
Maltese: Minħabba li din hi soluzzoni ta' proteini, jista' jkun hemm flokkulazzjoni ħafifa (ikun hemm fibri trasluċidi).
English: When diluted in 250 ml, the initial infusion rate should be 6 ml/hr.
Maltese: Meta jiġi dilwit f'250 ml, ir-rata ta' infużjoni inizjali għandha tkun 6 ml/hr.
English: All patients developed antibodies to elosulfase alfa in clinical studies.
Maltese: Il-pazjenti kollha żviluppaw antikorpi għal elosulfase alfa fl-istudji kliniċi.
English: Vimizim contains an enzyme called elosulfase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Maltese: Vimizim fih enzima li tissejjaħ elosulfase alfa, li tappartjeni għal grupp ta' mediċini magħrufin bħala terapiji ta' sostituzzjoni tal-enzimi.
English: The pharmacokinetic parameters of elosulfase alfa were evaluated in 23 patients with MPS IVA who received weekly intravenous infusions of 2 mg/kg of elosulfase alfa over approximately 4 hours for 22 weeks and the parameters at Week 0 and Week 22 were compared.
Maltese: Il-parametri farmakokinetiċi ta' elosulfase alfa ġew evalwati fi 23 pazjent b'MPS IVA li rċevew infużjonijet ta' 2 mg/kg elosulfase alfa ġol-vina kull ġimgħa fuq madwar 4 sigħat għal 22 ġimgħa u lparametri ta' Ġimgħa 0 u ta' Ġimgħa 22 tqabblu ma' xulxin.
English: Aseptic technique is to be used.
Maltese: Għandha tintuża teknika asettika.
English: Safety and pharmacodynamic results in these patients are consistent with results observed in the first 52 weeks (see section 4.8).
Maltese: Riżultati ta' sigurtà u farmakodinamiċi f'dawn ilpazjenti huma konsistenti mar-riżultati osservati fl-ewwel 52 ġimgħa (ara sezzjoni 4.8).
English: The most common symptoms of IRs (occurring in ≥ 10% of patients treated with Vimizim and ≥ 5% more when compared to placebo) were headache, nausea, vomiting, pyrexia, chills and abdominal pain.
Maltese: L-aktar sintomi komuni ta' RI (li seħħew f'≥ 10% tal-pazjenti kkurati b'Vimizim u ≥ 5% aktar meta mqabbla ma' plaċebo) kienu uġigħ ta' ras, tqalligħ, remettar, deni, tertir u uġigħ addominali.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology evaluating central nervous, respiratory and cardiovascular systems, single-dose and repeated-dose toxicity in rats and monkeys or fertility and embryo-foetal development in rats or rabbits.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika li jevalwa s-sistema nervuża ċentrali, sistemi respiratorji u kardjovaskulari, effett tossiku minn doża waħda u dożi ripetuti fil-firien u xadini, jew fertilità u iżvilupp embrijofetali, fil-firien jew fniek, ma juri l-ebda periklu speċjali għall-bnedmin.
English: • Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials 2.
Maltese: • Ammont totali (ml) ta' Vimizim diviż b'5 ml kull kunjett = Għadd totali ta' kunjetti.
English: When diluted with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 3 ml/hr.
Maltese: Meta jiġi dilwit b'100 ml ta' 9 mg/ml (0.9 %) sodium chloride soluzzjoni għall-infużjoni; irrata inizjali għandha tkun ta' 3 ml/hr.
English: The modelled treatment effect in stairs climbed per minute, compared to placebo, was 1.1 stairs/minute (CI95, -2.1, 4.4; p=0.4935) for the 2 mg/kg per week regimen.
Maltese: L-effett modellat tal-kura fit-tlugħ tat-taraġ kull minuta, meta mqabbel mal-plaċebo, kien ta' 1.1 taraġ/minuta (Cl95, -2.1, 4.4; p=0.4935) għall-programm ta' kura ta' 2 mg/kg fil-ġimgħa.
English: Table 3: Results from placebo-controlled clinical study at 2 mg per kg per week
Maltese: Tabella 3: Riżultati mill-istudju kliniku kkontrollat bi plaċebo f'2 mg kull kg kull ġimgħa
English: When diluted in 100 ml, the initial infusion rate should be 3 ml/hr.
Maltese: Meta jiġi dilwit f'100 ml, ir-rata ta' infużjoni inizjali għandha tkun 3 ml/hr.
English: Enzyme uptake by cells into lysosomes is mediated by cation independent mannose-6-phosphate receptors leading to restored GALNS activity and clearance of KS and C6S.
Maltese: It-teħid ta' ċelluli ġo lisosomi jsir permezz ta' riċettaturi li huma indipendenti mill-katajin ta' mannose-6-phosphate li jwassal għal attività ristorata ta' GALNS u t-tneħħija ta' KS u C6S.
English: The secondary endpoints were the change from baseline in the 3 Minute Stair Climb Test (MSCT) and urine KS levels at Week 24.
Maltese: It-punti ta' riferiment sekondarji kienu ittibdil mil-linja bażi fit-test ta' tlugħ tat-taraġ fi 3 minuti (3 MSCT - 3 Minute Stair Climb Test) u llivelli ta' KS fl-awrina f'Ġimgħa 24.
English: A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical studies.
Maltese: B'kollox ġew irreġistrati 235 pazjent b'MPS IVA u dawn ġew esposti għal Vimizim f'sitt studji kliniċi.
English: Step 5 minutes (ml/hr)
Maltese: Pass 5 minuta (ml/hr)
English: Sustained improvements in efficacy measures and reductions in urine keratan sulphate (KS) over time were observed across studies, despite the presence of anti elosulfase alfa antibodies.
Maltese: Titjib sostnut fil-miżuri ta' effikaċja u tnaqqis filkeratan sulphate (KS) fl-awrina maż-żmien kienu osservati fl-istudji, minkejja l-preżenza ta' antikorpi kontra elosulfase alfa.
English: Despite the alteration of the pharmacokinetics profile, presence of neutralizing antibodies did not affect pharmacodynamics, efficacy, or safety of the patients who were treated with elosulfase alfa.
Maltese: Minkejja l-alterazzjoni fil-profil farmakokinetiku, il-preżenza ta' antikorpi newtralizzanti ma affettwawx il-farmakodinamiċi, l-effikaċja, jew is-sigurtà tal-pazjenti li ġew ikkurati b'elosulfase alfa.
English: Anaphylaxis and severe allergic reactions have been reported in clinical studies.
Maltese: Anafilassi u reazzjonijiet allerġiċi severi ġew irrapportati fi studji kliniċi.
English: 3-Minute stair climb test (stairs/minute)
Maltese: Test ta' tlugħ ta' taraġ fi 3 minuti (taraġ/minuta)
English: Vimizim has to be diluted with sodium chloride 9 mg/ml (0.9 %) solution for infusion using aseptic technique.
Maltese: Vimizim jiġi dilwit b'soluzzjoni ta' 9 mg/ml (0.9 %) sodium chloride għall-infużjoni permezz ta' teknika asettika.
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fi friġġ (2C - 8C) Tagħmlux fil-friża.
English: Step 2 minutes (ml/hr)
Maltese: Pass 2 minuta (ml/hr)
English: Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Maltese: Vimizim huwa indikat għall-kura ta' mukopolisakkaridjosi, tip IVA (Sindromu ta' Morquio A, MPS IVA) f'pazjenti ta' kull età.
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Sensittività eċċessiva li tista' tkun ta' periklu għall-ħajja (reazzjoni anafilattika) għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.4). 4.4
English: IgE antibodies against elosulfase alfa were detected in ≤ 10% of treated patients and have not consistently been related to anaphylaxis or other hypersensitivity reactions and/or treatment withdrawal.
Maltese: IgE kontra elosulfase f'≤ 10% tal-pazjenti kkurati u dawn ma kinux konsistentament relatati ma' anafilassi jew ma' reazzjonijiet oħra ta' sensittività eċċessiva u/jew irtirar mill-kura.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Maltese: Qabel it-tnedija f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-programm edukattiv mal-awtorità nazzjonali kompetenti.
English: Diarrhoea, vomiting, oropharyngeal pain, upper abdominal pain, abdominal pain, nausea
Maltese: Dijarea, rimettar, uġigħ orofarinġeali, uġigħ fuq in-naħa ta' fuq taż-żaqq, uġigħ addominali, tqalligħ
English: The data in Table 2 below describes adverse reactions from clinical studies in patients treated with Vimizim.
Maltese: It-tagħrif f'Tabella 2 hawn isfel jiddeskrivi reazzjonijiet avversi minn studji kliniċi f'pazjenti trattati b'Vimizim.
English: This medicine contains 8 mg sodium (main component of cooking/table salt) in each 5 ml vial.
Maltese: Din il-mediċina fiha 8 mg sodium (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull kunjett ta' 5 ml.
English: Serious IRs were observed in clinical studies and included anaphylaxis, hypersensitivity and vomiting.
Maltese: RI serji kienu osservati fl-istudji kliniċi u kienu jinkludu anafilassi, sensittività eċċessiva u rimettar.
English: o all patients should receive antihistamines with or without antipyretics 30-60 minutes prior to the start of infusion o appropriate medical support should be readily available when VIMIZIM® is administered o the need to immediately stop the infusion and initiate appropriate medical treatment if these reactions occurred
Maltese: o il-pazjenti kollha għandhom jirċievu antistamini bi jew mingħajr antipiretiċi 30-60 minuta o qabel il-bidu tal-infużjoni o għandu jkun disponibbli fil-pront appoġġ mediku xieraq meta jingħata VIMIZIM®
English: Your doctor may also give you additional medicines to manage any allergic reactions (e.g. antihistamines and/or corticosteroids).
Maltese: It-tabib tiegħek jista' wkoll jagħtik mediċini addizzjonali sabiex jiġġestixxi kull reazzjoni allerġika (eż, antiħistamini u/jew kortikosterojdi).
English: Impact of antibodies on elosulfase alfa pharmacokinetics was assessed.
Maltese: Ġie vvalutat l-impatt ta' antikorpi fuq il-farmakokinetiċi ta' elosulfase alfa.
English: Step 6 minutes (ml/hr)
Maltese: Pass 6 minuta (ml/hr)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM JEW PARTI INDIVIDWALI 5 mg/5 ml
English: People with MPS IVA disease either lack completely or do not have enough N-acetylgalactosamine-6sulfatase, an enzyme which breaks down specific substances in the body such as keratan sulphate, which are found in many tissues of the body, including cartilage and bone.
Maltese: Normalment, persuni bil-marda ta' MPS IVA jew ikunu nieqsa kompletament jew ma jkollhomx biżżejjed N-acetylgalactosamine-6-sulfatase, enzima li tkisser sustanzi speċifiċi fil-ġisem bħal keratan sulphate, li jinstabu f'ħafna tessuti tal-ġisem, inkluż il-qarquċa u l-għadam.
English: Clinical studies performed with Vimizim assessed the impact of treatment on the systemic manifestations of MPS IVA in various domains including endurance, respiratory function, growth velocity, and mobility, as well as urine KS.
Maltese: Studji kliniċi li saru b'Vimizim ivvalutaw l-impatt tal-kura fuq il-manifestazzjonijiet ta' MPS IVA f'oqsma varji li jinkludu l-felħan, il-funzjoni respiratorja, veloċità tal-iżvilupp, u l-mobilità, kif ukoll il-KS fl-urina.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of elosulfase alfa.
Maltese: Konsegwentement,funzjoni tal-fwied indebolita mhix mistennija taffettwa l-farmakokinetiċi ta' elosulfase alfa.
English: Clear glass vial (Type I) with a butyl rubber stopper and a flip-off crimp seal (aluminium) with a plastic cap.
Maltese: Kunjett tal-ħġieġ ċar (Tip I) b'tapp tal-lastku tal-butyl u siġill ippjegat (aluminju) li jinqala b'saba' b'għatu tal-plastik.
English: Step 4 minutes (ml/hr)
Maltese: Pass 4 minuta (ml/hr)
English: It is used to treat adults and children with mucopolysaccharidosis type IVA (MPS IVA disease, also known as Morquio A Syndrome).
Maltese: Huwa jintuża biex jikkura adulti u tfal bil-marda ta' mukopolisakkaridosi tip IVA (marda ta' MPS IVA, magħrufa wkoll bħala Sindromu ta' Morquio A).
English: • Patients weighing less than 25 kg should receive a total volume of 100 ml.
Maltese: • Pazjenti li jiżnu inqas minn 25 kg jew inqas għandhom jirċievu volum totali ta' 100 ml.
English: IRs may include allergic reactions.
Maltese: RI jistgħu jinkludu reazzjonijiet allerġiċi.
English: Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI).
Maltese: Trabi u tfal żgħar (li jkollhom taħt sentejn) jistgħu jkunu għadhom ma ġewx iddijanjostikati b'intolleranza ereditarja għall-fructose (HFI).
English: Step 3 minutes (ml/hr)
Maltese: Pass 3 minuta (ml/hr)
English: Patients weighing 25 kg or more should receive a total volume of 250 ml.
Maltese: Pazjenti li jiżnu 25 kg jew aktar għandhom jirċievu volum totali ta' 250 ml.
English: No association was apparent between the total antibody titre and elosulfase clearance.
Maltese: Ma dehret ebda rabta bejn it-titer totali ta' antikorpi u l-eliminazzjoni ta' elsosulfase.
English: The volume of Vimizim is to be slowly added to the sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Maltese: Il-volum ta' Vimizim għandu jiġi miżjud bil-mod mal- 9 mg/ml (0.9 %) sodium chloride soluzzjoni għall-infużjoni.
English: A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from a 100 ml or 250 ml infusion bag equal to the total volume of Vimizim to be added.
Maltese: Għandu jitneħħa volum ta' 9 mg/ml (0.9 %) tas-soluzzjoni għall-injezzjoni ta' sodium chloride minn ġol-borża tal-infużjoni ta' 100 ml jew ta' 250 ml, ugwali għall-volum totali ta' Vimizim li għandu jiżdied.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: • Patients weighing 25 kg or more should receive a total volume of 250 ml.
Maltese: • Pazjenti li jiżnu 25 kg jew aktar għandhom jirċievu volum totali ta' 250 ml.
English: Infusion reactions (IRs) were the most commonly observed adverse reactions in clinical studies.
Maltese: Reazzjonijiet ta' infużjoni (RI) kienu l-aktar reazzjonijiet avversi komuni osservati fl-istudji kliniċi.
English: Renal elimination of elosulfase alfa is considered a minor pathway for clearance.
Maltese: L-eliminazzjoni renali ta' elosulfase hija meqjusa passaġġ minuri għall-eliminazzjoni.
English: Patients weighing less than 25 kg should receive a total volume of 100 ml.
Maltese: Pazjenti li jiżnu inqas minn 25 kg għandhom jirċievu volum totali ta' 100 ml.
English: Set up a MPS IVA disease Registry to assess the long term safety and efficacy of elosulfase alfa.
Maltese: Jitwaqqaf Reġistru tal-mard tal-MPS IVA biex tiġi vvalutata s-sigurtà u l-effikaċja fittul ta' elosulfase alfa.
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion reactions”).
Maltese: Effetti sekondarji dehru prinċipalment waqt li pazjenti kienu qed jingħataw il-mediċina jew ftit wara (“reazzjonijiet ta' infużjoni”).
English: Biotransformation
Maltese: Differenza filbidliet
English: Patients should be monitored for signs and symptoms of SCC (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Maltese: Ilpazjenti għandhom jiġu sorveljati għal sinjali u sintomi ta' SCC (li jinkludu uġigħ fid-dahar, paraliżi tad-dirgħajn jew riġlejn taħt il-livell ta' kompressjoni, inkontinenza urinali u tal-ippurgar) u għandhom jingħataw kura klinika.
English: How to store Vimizim
Maltese: Kif jaħdem Vimizim
English: After dilution
Maltese: U LUŻU
English: Reproduction studies have been performed in rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or reproductive performance.
Maltese: Studji dwar ir-riproduzzjoni saru filġrieden f'dożi li kienu sa 10 darbiet id-doża tal-bniedem u ma wrew l-ebda evidenza ta' fertilità jew rendiment riproduttiv indebolit.
English: Chang e
Maltese: TA' KIF JINGĦATA
English: An infusion set equipped with an in-line 0.2 μm filter can be used.
Maltese: Jista' jintuża sett ta' infużjoni mgħammar b'filtru ta' 0.2 µm fil-pajp.
English: Male and female patients had comparable elosulfase alfa clearance, and clearance did not trend with age or weight at week 22.
Maltese: Pazjenti rġiel u nisa kellhom eliminazzjoni komparabbli ta' elosulfase alfa, u l-eliminazzjoni ma kinitx dovuta għal xi tendenza ta' età jew piż f'Ġimgħa 22.
English: Each ml of concentrate contains 1 mg elosulfase alfa.
Maltese: Kull millilitru ta' konċentrat ta' Vimizim fih 1 mg elosulfase alfa.
English: In clinical studies, doses of elosulfase alfa were explored up to 4 mg/kg per week and no specific signs or symptoms were identified following the higher doses.
Maltese: Fl-istudji kliniċi, ġew esplorati dożi ta' elosulfase alfa sa 4 mg/kg fil-ġimgħa u ma ġie identifikat lebda sinjal jew sintomu speċifiku wara d-dożi l-għoljin.
English: INSTRUCTIONS ON USE
Maltese: Bażi ta' Riferiment
English: How to store Vimizim 6.
Maltese: Kif jingħata Vimizim 4.
English: Baselin e
Maltese: Ż-ŻGĦAR EWLENIN
English: 1 to 2 implantation matrices
Maltese: Matriċi 1 sa 2 għallimpjantazzjoni
English: EU (MA) number (Invented)
Maltese: Numru ta' l-EU (MA)
English: Dish cells/cm²
Maltese: Il-pakkett li jmiss malprodott
English: Pack size
Maltese: Dixx
English: Pack size
Maltese: Mnejn għandu jingħata Il-pakkett
English: 2005 Nov
Maltese: Circulation. 2005 Nov
English: Kotwall et al. Omega 3 Fatty acids and Cardiovascular Outcomes Systematic and Meta-Analysis, Circ Cardiovasc Qual Outcomes 2012;5:808-818
Maltese: Omega 3 Fatty acids and Cardiovascular Outcomes Systematic and Meta-Analysis, Circ Cardiovasc Qual Outcomes 2012;5:808-818
English: DOI: 10.1056/NEJMoa1811403
Maltese: 1056/NEJMoa1811403
English: DOI: 10.1056/NEJMoa1812792
Maltese: 1056/NEJMoa1812792
English: 2013;8(5):e62772.
Maltese: PLoS One. 2013;8(5):e62772.
English: 2013 Jan;35(1):40-51
Maltese: Clin Ther. 2013 Jan;35(1):40-51
English: 2006 Jun 14;295(22):2613-9.
Maltese: JAMA. 2006 Jun 14;295(22):2613-9.
English: 3 Kwak et al. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and decosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials.
Maltese: Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and decosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials.
English: JAMA.
Maltese: MI.
English: Recently published RCTs (ASCEND by Bowman et al. 201812, VITAL by Manson et al. 201913, REDUCEIT by Bhatt et al. 201914) do not provide evidence for the efficacy of omega-3 administration (1 g daily) for the indication under review.
Maltese: RCTs ippubblikati riċentement (ASCEND minn Bowman et al. 201812, VITAL minn Manson et al. 201913, REDUCE-IT minn Bhatt et al. 201914) ma jipprovdux evidenza għall-effikaċja tal-għoti ta' omega-3 (1 g kuljum) għall-indikazzjoni li qed tiġi rieżaminata.
English: Two of the studies (Greene5 and Macchia6) included a large number of subjects and for the latter, the documented risk reduction for all-cause mortality was 37% (RR 0.63 CI 0.56-0.72).
Maltese: Tnejn mill-istudji (Greene5 u Macchia6) inkludew numru kbir ta' individwi u għal dawn tal-aħħar, it-tnaqqis dokumentat tar-riskju għallmortalità mill-kawżi kollha kien ta' 37 % (RR 0.63 CI 0.56-0.72).
English: Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77917 Individuals.
Maltese: Meta-analysis of 10 Trials Involving 77917 Individuals.
English: Based on the results, there is only a 2.5% chance that the relative risk reduction for MACE exceeds 4%.
Maltese: Abbażi tar-riżultati, hemm biss probabbiltà ta' 2.5 % li t-tnaqqis relattiv fir-riskju għal MACE jaqbeż 4 %.
English: The original approval of Omacor (EU reference medicinal product) was based on an open-label study (GISSI-P) from 1999.
Maltese: L-approvazzjoni oriġinali ta' Omacor (prodott mediċinali ta' referenza tal-UE) kienet ibbażata fuq studju open-label (GISSI-P) mill-1999.
English: 2017 Sep;49(3):255-261
Maltese: J Interv Card Electrophysiol. 2017 Sep;49(3):255-261
English: Similar to OMEGA trial, a lack of effect of in this indication was observed.
Maltese: MI. Simili għall-prova OMEGA, ġie osservat nuqqas ta' effett f'din l-indikazzjoni.
English: Clin Ther.
Maltese: Deepak L.
English: ASCEND: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes.
Maltese: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes. https://doi.org/10.1016/j.ahj.2017.12.006.
English: Even though the incidence of sudden death may have been too low to draw firm conclusions, the OR was 1.25 (0.90-1.72) for total mortality and 1.21 for MACE (0.96 - 1.52), so it is considered unlikely that a beneficial effect could have been shown with a larger trial.
Maltese: Anki jekk l-inċidenza ta' mewt għall-għarrieda setgħet kienet baxxa wisq biex twassal għal konklużjonijiet sodi, l-OR kien 1.25 (0.90-1.72) għal mortalità totali u 1.21 għal MACE (0.96 - 1.52), u għalhekk huwa meqjus improbabbli li effett ta' benefiċċju seta' jintwera bi prova ikbar.
English: Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial.
Maltese: Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J.
English: Total mortality was also numerically higher in the omega-3 fatty acids group OR 1.25 (0.90-1.72).
Maltese: Il-mortalità totali wkoll kienet numerikament ogħla fil-grupp tal-aċidi xaħmin omega-3 OR 1.25 (0.90-1.72).
English: The OMEGA study included close to 2000 patients in both arms and over 300 MACE events were reported, more in the omega-3 group than in the placebo group OR 1.25 (0.96-1.52).
Maltese: L-istudju OMEGA inkluda kważi 2000 pazjent fiż-żewġ fergħat u ġew irrappurtati aktar minn 300 avveniment MACE, aktar fil-grupp ta' omega-3 milli fil-grupp ta' plaċebo OR 1.25 (0.96-1.52).
English: Following the adoption of the CHMP opinion in December 2018, a re-examination request was received from the MAHs involved in the procedure, BASF AS (representing Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A and Strides Arcolab International Limited) and ALFASIGMA S.p.A (on behalf of DOC GENERICI S.r.l., EG S.p.A., IBSA FARMACEUTICI ITALIA S.r.l., PFIZER ITALIA S.r.l., SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.p.A.).
Maltese: Wara l-adozzjoni tal-opinjoni tas-CHMP f'Diċembru 2018, ġiet riċevuta talba għal eżaminazzjoni millġdid mill-MAHs involuti fil-proċedura, BASF AS (li tirrappreżenta Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A u Strides Arcolab International Limited) u ALFASIGMA