FrancophonIA/ELRC3.0 huggingface dataset:
English: Omega-3 acid ethyl esters are an ethyl esters of long-chain polyunsaturated fatty acids with an eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) content of no less than 85% and an EPA to DHA ratio of 0.9 to 1.5.
Maltese: L-esteri etiliċi tal-aċidu omega-3 huma esteri etiliċi ta' aċidi xaħmin poliinsaturati ta' katina twila b'aċidu ejkosapentenojku (EPA), u b'kontenut ta' aċidu dokosaeżaenojku (DHA) ta' mhux inqas minn 85 % u proporzjon EPA għal DHA ta' 0.9 sa 1.5.
English: Although statin use increased during the study, it was only 28 - 29% at 6 months and 44 - 46% at 42 months.
Maltese: Għalkemm l-użu ta' statini żdied matul l-istudju, kien biss 28 - 29 % f'sitt xhur u 4446 % fit-42 xahar.
English: The OMEGA trial was conducted in patients with the approved indication, i.e. MI and used the approved dose of Omacor (1 g/day).
Maltese: Il-prova OMEGA saret f'pazjenti bl-indikazzjoni approvata, jiġifieri MI u użat id-doża approvata ta' Omacor (1 g/jum).
English: Studies in patients with an implantable cardioverter defibrillator (ICD) showed inconsistent results regarding antiarrhythmic efficacy (Leaf et al.8, 2005; Brouwer et al.9 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
Maltese: Studji f'pazjenti b'defibrillatur kardjovertri impjantabbli (ICD) urew riżultati inkonsistenti rigward leffikaċja antiarritmika (Leaf et al.8, 2005;
English: The efficacy of omega-3 fatty acids in the claimed indication has also not been demonstrated by other relevant RCTs conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke ), including ORIGIN, SU.FOL.OM3, ASCEND, and VITAL.
Maltese: Lanqas ma ntweriet l-effikaċja tal-aċidi xaħmin omega-3 fl-indikazzjoni ddikjarata minn RCTs rilevanti oħrajn li saru f'popolazzjonijiet oħra b'riskju ta' CV (eż. rivaskularizzazzjoni koronarja, anġina pectoris, puplesija iskemika), inkluż ORIGIN, SU.FOL.OM3, ASCEND, u VITAL.
English: Vitamin E is not considered beneficial in the prophylaxis of cardiovascular events.
Maltese: Il-Vitamina E mhijiex meqjusa ta' benefiċċju fil-profilassi ta' avvenimenti kardjovaskulari.
English: Studies investigating the effect of omega-3 acid ethyl esters medicinal products on atrial and ventricular arrhythmias did not demonstrate a clinically relevant antiarrhythmic efficacy.
Maltese: Studji li investigaw l-effett ta' prodotti mediċinali esteri etiliċi tal-aċidu omega-3 fuq arritmiji atrijali u ventrikulari ma wrewx effikaċja antiarritmika klinikament rilevanti.
English: 6 Macchia A, Romero M, D'Ettorre A, Tognoni G, Mariani J. Exploratory analysis on the use of statins with or without n-3 PUFA and major events in patients discharged for acute myocardial infarction: an observational retrospective study.
Maltese: Exploratory analysis on the use of statins with or without n-3 PUFA and major events in patients discharged for acute myocardial infarction: an observational retrospective study.
English: • The OMEGA trial (performed in 2010 after the original approval of the secondary prevention indication) was a well performed, double blind trial evaluating a population well representative of the currently approved secondary prevention indication, including the use of standard of care treatment.
Maltese: • Il-prova OMEGA (li saret fl-2010 wara l-approvazzjoni oriġinali tal-indikazzjoni ta' prevenzjoni sekondarja) kienet prova mwettqa sew u double blind li evalwat popolazzjoni rappreżentattiva sew tal-indikazzjoni ta' prevenzjoni sekondarja approvata attwalment, inkluż l-użu talistandard tal-kura.
English: Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis.
Maltese: Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis.
English: In addition, in other prospective randomised trials performed after the original approval (GISSI-HF, ORIGIN study and SU.FOL.OM3 performed between 2003 and 2012), as well as in meta-analyses (e.g. by Aung et al. 20184), the results from the GISSI-P study could also not be reproduced.
Maltese: Barra minn hekk, fi provi prospettivi randomizzati oħrajn imwettqa wara l-approvazzjoni oriġinali (GISSI-HF, studju ORIGIN u SU.FOL.OM3 imwettqa bejn l-2003 u l-2012), kif ukoll f'meta-analiżijiet (eż. minn Aung et al. 20184), ir-riżultati mill-istudju GISSI-P ma setgħux jiġu riprodotti wkoll.
English: Beta-blockers that are indicated in most patients post MI were only used in 37 - 44% in GISSI-P.
Maltese: Imblokkaturi tar-riċetturi beta li huma indikati fil-biċċa l-kbira tal-pazjenti wara l-MI ntużaw biss f'37-44 % f'GISSI-P.
English: JoAnn E. Manson, Nancy R. Cook, I‑Min Lee, William Christen, Shari S. Bassuk, Samia Mora, Heike Gibson, Christine M. Albert, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L. Giovannucci, Walter C. Willett, and Julie E. Buring, for the VITAL Research Group.
Maltese: Albert, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L. Giovannucci, Walter C.
English: All these studies carry the risk of a selection bias, which is supported by baseline data provided, e.g. in the retrospective cohort study by Polle (2013)7 only 1 % of post MI patients who were screened were included in the analysis.
Maltese: Dawn l-istudji kollha għandhom ir-riskju ta' għażla preġudikata, li huwa appoġġat minn data tal-linja bażi pprovduta, eż. fl-istudju koorti retrospettiv minn Polle (2013)7 1 % biss tal-pazjenti wara l-MI li ġew skrinjati kienu inklużi fl-analiżi.
English: In this study, there was a relative risk reduction for one of the two primary MACE endpoint (death, non-fatal MI and non-fatal stroke) of 10% with a rather poor precision (upper CI 0.99), whereas for the other primary endpoint including cardiovascular (CV), instead of all-cause death, statistical significance was not achieved.
Maltese: F'dan l-istudju, kien hemm tnaqqis relattiv fir-riskju għal wieħed miżżewġ punti ta' tmiem primarji MACE (mewt, MI mhux fatali u puplesija mhux fatali) ta' 10 % bi preċiżjoni pjuttost batuta (CI ta' fuq 0.99), filwaqt li għall-punt ta' tmiem primarju l-ieħor inkluż kardjovaskulari (CV), minflok il-mewt mill-kawżi kollha, ma nkisbitx sinifikanza statistika.
English: However, later studies, including meta-analyses1,2,3 have failed to show a beneficial effect in this condition.
Maltese: Madankollu, studji aktar tard, inklużi meta-analiżijiet1,2,3 ma rnexxilhomx juru effett ta' benefiċċju f'din ilkundizzjoni.
English: • The Committee for Medicinal Products for Human Use (CHMP) considered the procedure under Article 31 of Directive 2001/83/EC for Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction.
Maltese: • Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom esteri etiliċi talaċidu Omega-3 għall-użu orali fil-prevenzjoni sekondarja wara infart mijokardijaku.
English: Upon request from the CHMP, a SAG CVS meeting was convened on 10 October 2018.
Maltese: Fuq talba mis-CHMP, saret laqgħa SAG CVS fl-10 ta' Ottubru 2018.
English: PLoS One.
Maltese: Anness II
English: Treatment with icosapent ethyl 4g/day was associated with an increase in hospitalization for atrial fibrillation of flutter in the REDUCE-IT trial.
Maltese: Il-kura b'icosapent ethyl 4g/jum kienet assoċjata ma' żieda fi dħul fl-isptar għal fibrillazzjoni atrijali ta' aġitazzjoni fil-prova REDUCE-IT.
English: However, ignoring double blind by using no treatment as comparator (as in GISSI-P) ignores another important concept in clinical trials, i.e. the use of a (blinded) comparator in order to control the other effects than the investigational drug, and deviation of this principle should only be needed or suitable "when it is difficult or impossible to avoid" (ICH E10 guideline on Choice of control group in clinical trials).
Maltese: Madankollu, jekk jiġi injorat double blind billi ma tintużax kura bħala komparatur (bħal f'GISSI-P), jiġi injorat kunċett importanti ieħor fil-provi kliniċi, jiġifieri l-użu ta' komparatur (blinded) sabiex jikkontrolla l-effetti l-oħra minbarra l-mediċina ta' investigazzjoni, u d-devjazzjoni ta' dan il-prinċipju għandha tkun meħtieġa jew xierqa biss “meta jkun diffiċli jew impossibbli li tiġi evitata” (linja gwida ICH E10 dwar l-Għażla ta' grupp ta' kontroll fil-provi kliniċi).
English: Upon request from the MAHs, a second SAG CVS meeting was convened on 19 March 2019.
Maltese: Fuq talba mill-MAHs, fid-19 ta' Marzu 2019 saret it-tieni laqgħa tal-SAG CVS.
English: This included the responses submitted by the marketing authorisation holders in writing and during an Oral Explanation, as well as the outcome of the consultation with the Cardiovascular Scientific Advisory Group on the 10 of October 2018.
Maltese: Dan inkluda t-tweġibiet bil-miktub sottomessi mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq u waqt Spjegazzjoni Orali, kif ukoll ir-riżultat tal-konsultazzjoni mal-Grupp Konsultattiv Xjentifiku Kardjovaskulari fl-10 ta' Ottubru 2018.
English: Only a limited amount of parameters in these retrospective analyses were available.
Maltese: Ammont limitat ta' parametri biss f'dawn lanaliżijiet retrospettivi kien disponibbli.
English: Therefore, the key concern that standard of care after MI has intensified since the time of the GISSI-P study, in particular statin therapy, beta-blockers and PCI, still remains.
Maltese: MI intensifika minn meta sar l-istudju GISSI-P, b'mod partikolari terapija bi statini, imblokkaturi tar-riċetturi beta u PCI.
English: The provided meta-analyses showed both positive and negative effects of omega-3 fatty acid treatment on the risk of cardiovascular events.
Maltese: Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks:
English: The results of the recently published REDUCE-IT trial are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs. 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Maltese: Ir-riżultati tal-prova REDUCE-IT li ġiet ippubblikata riċentement huma ta' rilevanza limitata peress li d-doża ta' kuljum kienet ħafna aktar għolja mid-doża tal-indikazzjoni li qed tiġi rieżaminata (4 g kontra 1 g) u s-sustanza attiva kienet icosapent ethyl, etilester EPA ppurifikat ħafna, minflok taħlita ta' EPA u DHA.
English: The OMEGA trial was a large prospective, double blind, randomized study including a population highly representative of the target population including the use of standard of care treatment.
Maltese: Il-prova OMEGA kienet studju prospettiv kbir, double blind u randomizzat li inkludiet popolazzjoni rappreżentattiva ħafna tal-popolazzjoni fil-mira inkluż l-użu ta' kura tal-istandard tal-kura.
English: The three retrospective studies (Poole et al 2013, Greene et al 2016, Macchia et al 2013) are considered to have sufficiently large populations of subjects diagnosed with acute MI and studied omega-3-fatty acids in the relevant dose of 1 g daily with all-cause mortality as the main endpoint.
Maltese: It-tliet studji retrospettivi (Poole et al 2013, Greene et al 2016, Macchia et al 2013) jitqiesu bħala li għandhom popolazzjonijiet ta' individwi kbar biżżejjed dijanjostikati b'MI akuta u studjaw l-aċidi xaħmin omega-3 fid-doża rilevanti ta' 1 g kuljum bil-mortalità mill-kawżi kollha bħala l-punt ta' tmiem ewlieni.
English: With respect to safety, the PRAC concluded in the last PSUSA (January 2017) that no new safety issues had emerged.
Maltese: Fir-rigward tas-sigurtà, il-PRAC ikkonkluda fl-aħħar PSUSA (Jannar 2017) li ma feġġet l-ebda kwistjoni ġdida ta' sigurtà.
English: Moreover, the population included in the REDUCE-IT trial is not comparable with the population of the GISSI-P trial and the indication under review (patients with history of MI), since in addition to established cardiovascular disease or diabetes and other risk factors, patients in the REDUCE-IT trial suffered also from hypertriglyceridemia (> 60% of the patients had TG levels ≥ 200 mg/dL)
Maltese: Barra minn hekk, il-popolazzjoni inkluża fil-prova REDUCE-IT mhijiex komparabbli malpopolazzjoni tal-prova GISSI-P u l-indikazzjoni li qed tiġi rieżaminata (pazjenti bi storja ta' MI), peress li minbarra marda kardjovaskulari stabbilita jew dijabete u fatturi ta' riskju oħra, il-pazjenti fil-prova REDUCE-IT batew ukoll minn ipertrigliċeridemija (> 60% tal-pazjenti kellhom livelli
English: Even though the incidence of sudden death may have been too low to draw firm conclusions, the OR for MACE and total mortality was above 1.21 and 1.25 respectively with lower CI close to 1 not supporting an effect in the approved indication.
Maltese: Anki jekk l-inċidenza ta' mewt għall-għarrieda setgħet kienet baxxa wisq biex twassal għal konklużjonijiet sodi, l-OR għal MACE u l-mortalità totali kienet 'il fuq minn 1.21 u 1.25 rispettivament, b'CI t'isfel viċin 1 li ma jappoġġax l-effett fl-indikazzjoni approvata.
English: 7 Poole CD, Halcox JP, Jenkins-Jones S, Carr ES, Schifflers MG, Ray KK, et al. Omega-3 Fatty acids and mortality outcome in patients with and without type 2 diabetes after myocardial infarction: a retrospective, matched-cohort study.
Maltese: Omega-3 Fatty acids and mortality outcome in patients with and without type 2 diabetes after myocardial infarction: a retrospective, matched-cohort study.
English: The MAHs citation of relevant guideline "included clinical trials need to be longterm controlled (usually 12 months or longer), parallel and preferably double-blind" is correct.
Maltese: Il-kwotazzjoni tal-MAHs ta' linja gwida rilevanti “bl-inklużjoni li provi kliniċi jeħtieġ li jiġu kkontrollati fit-tul (normalment 12-il xahar jew aktar), paralleli u preferibbilment double-blind” hija korretta.
English: • Based on the totality of the data emerging after the original approval as well as the limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary prevention after myocardial infarction at the dose of 1 g/day and, although the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
Maltese: • Ġie ipotezizzat li r-riżultati tal-prova GISSI-P kienu xprunati minn riskju mnaqqas ta' mewt għall-għarrieda, potenzjalment ibbażat fuq effett antiarritmiku ta' OMEGA-3. Dan l-effett pożittiv potenzjali fuq il-mortalità ma ġiex riprodott fi provi sussegwenti u l-effett antiarritmiku ma ġiex ikkonfermat fi provi li jeżaminaw pazjenti b'ICD.
English: Although CHMP considers that the GISSI-P and the OMEGA trials are the most relevant for evaluating the effect of omega-3 containing products in the secondary prevention after MI, it is also acknowledged that RCTs (GISSI-HF, ORIGIN, SU.FOL.OM3) conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke) are as well relevant, as CV disease is still considered a continuum.
Maltese: Jekk kien hemm effikaċja antiarritmika ta' benefiċċju rilevanti tal-esteri etiliċi tal-aċidu omega-3, kif intqal, kien imissu kien rilevanti wkoll għal dawk il-popolazzjonijiet ta' pazjenti f'riskju kardjovaskulari miżjud inklużi f'dawn listudji.
English: • The CHMP considered the totality of the data submitted for omega-3 acid ethyl esters medicinal products with regard to their use in secondary prevention after myocardial infarction.
Maltese: • Is-CHMP ikkunsidra t-totalità tad-data sottomessa għall-prodotti mediċinali tal-esteri etiliċi talaċidu omega-3 fir-rigward tal-użu tagħhom fil-prevenzjoni sekondarja wara infart mijokardijaku.
English: The study formally failed because the primary analysis of one of the coprimary endpoints did not show a statistically significant difference.
Maltese: L-istudju formalment ma rnexxiex għax l-analiżi primarja ta' wieħed mill-punti ta' tmiem koprimarji ma wrietx differenza statistikament sinifikanti.
English: The primary objective of the OMEGA trial was to study the rate of sudden cardiac death testing one of the postulated mechanisms of action (antiarrhythmic) of Omega-3 in GISSI-P.
Maltese: L-objettiv primarju tal-prova OMEGA kien li tiġi studjata r-rata ta' mewt kardijaka għall-għarrieda li tittestja waħda mill-mekkaniżmi ta' azzjoni (antiarritmiċi) postulati ta' Omega-3 f'GISSI-P.
English: The MAHs proposed, as part of their grounds for re-examination, a modification of the indication for use in high-risk patients, i.e. type 2 diabetes, no acute PCI after MI, impaired systolic function (EF < 50%), known intolerance to one or more guideline recommended cardiovascular medications.
Maltese: MI, funzjoni sistolika indebolita (EF < 50%), intolleranza magħrufa għal medikazzjoni kardjovaskulari waħda jew aktar rakkomandata mil-linja gwida.
English: Studies included in the different meta-analysis are heterogeneous with respect to study population (e.g. patients with or without history of cardiovascular disease), study design (open-label or double-blind), source of omega-3 fatty acid intake (dietary or medication intervention), dose and composition of omega-3 fatty acid.
Maltese: L-istudji inklużi fil-metaanaliżi differenti huma eteroġeni fir-rigward tal-popolazzjoni tal-istudju (eż. pazjenti bi jew mingħajr storja ta' marda kardjovaskulari), tfassil tal-istudju (open-label jew double-blind), sors ta' teħid tal-aċidu xaħmi omega3 (intervent fid-dieta jew mediku), doża u kompożizzjoni tal-aċidu xaħmi omega-3.
English: Despite the lack of statistical power for the specific “sudden cardiac death” endpoint, the lack of substantial benefit can be concluded from this trial in a statistically valid way, as evidenced by the narrow confidence intervals.
Maltese: Minkejja n-nuqqas ta' saħħa statistika għall-punt ta' tmiem speċifiku ta' mewt kardijaka għallgħarrieda, in-nuqqas ta' benefiċċju sostanzjali jista' jiġi konkluż minn din il-prova b'mod statistikament validu, kif muri mill-intervalli ta' fiduċja dojoq.
English: With respect to the GISSI-P trial, no new issues have been identified, with the exception of the statement of the MAHs that post-hoc analyses conducted on GISSI-P demonstrated that concomitant treatment with anti-platelet agents, beta-blockers, ACE inhibitors and statins did not alter the therapeutic benefit of Omacor.
Maltese: Fir-rigward tal-prova GISSI-P, ma ġiet identifikata l-ebda kwistjoni ġdida, ħlief id-dikjarazzjoni tal-MAHs li analiżijiet posthoc li saru fuq GISSI-P urew li kura konkomitanti ma' sustanzi kontra l-pjastrini, imblokkaturi tarriċetturi beta, inibituri ta' ACE u statini ma bidlitx il-benefiċċji terapewtiku ta' Omacor.
English: The therapeutic effect of omega-3 fatty acids has been attributed to their possible involvement on eicosanoid balance, lipid metabolism, and cell membranes.
Maltese: L-effett terapewtiku tal-aċidi xaħmin omega-3 ġie attribwit għall-involviment possibbli tagħhom fuq ilbilanċ tal-eicosanoid, il-metaboliżmu tal-lipidi, u l-membrani taċ-ċelluli.
English: An example of a diabetes medicine that contains insulin in combination with a non-insulin active substance is Xultophy (100 units/ml insulin degludec and 3.6 mg/ml liraglutide) which was authorised in the EU on.
Maltese: Eżempju ta' mediċina kontra d-dijabete li fiha l-insulina flimkien ma' sustanza attiva li mhux insulina hija Xultophy (100 unità/ml insulina degludec u 3.6 mg/ml liraglutide) li kienet awtorizzata fl-UE fi.
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors, can be found in the guidance on risk minimisation strategies for high strength and fixed combination insulin products.
Maltese: Aktar informazzjoni dwar l-użu sikur ta' dawn il-mediċini u modi oħra biex jitnaqqas ir-riskju possibbli ta' żbalji ta' medikazzjoni tinstab fil-gwida dwar l-istrateġiji ta' tnaqqis tar-riskju għal prodotti ta' insulina ta' qawwa kbira u kkombinati b'mod fiss.
English: Your healthcare professional will give you this information.
Maltese: Il professjonist fil-kura tas-saħħa tiegħek sejjer jagħtik din l-informazzjoni.
English: • If the patient has been transferred from another pen device, highlight the differences in design between the two devices.
Maltese: • Jekk il-pazjent inqaleb minn apparat tal-pinna oħra, enfasizza d-differenzi fid-disinn bejn iż-żewġ apparati.
English: • Tell patients to closely monitor their blood sugar levels when starting a medicine containing insulin and a non-insulin active substance and in the weeks after.
Maltese: • Għid lill-pazjenti biex jissorveljaw il-livelli tagħhom taz-zokkor fid-demm bir-reqqa meta jibdew jużaw mediċina li fiha l-insulina u sustanza attiva li mhux insulina fil-ġimgħat ta' wara.
English: • One dose step contains a set number of units of insulin plus a fixed amount of the non-insulin medicine.
Maltese: • Kull pass tad-doża fih numru fiss ta' unitajiet ta' insulina kif ukoll ammont fiss ta' mediċina li mhux insulina.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing, prescribing and dispensing diabetes medicines that contain insulin in combination with a non-insulin active substance:
Maltese: Gwida dwar il-prevenzjoni ta' żbalji ta' medikazzjoni b'mediċini kontra d-dijabete li fihom l-insulina u sustanza attiva mhux insulina
English: • Your healthcare professional will explain the design and features of your pen, including how the dose counter of the pen device shows the number of dose steps to be injected.
Maltese: • Il-professjonist fil-kura tas-saħħa tiegħek sejjer jispjega d-disinn u l-karatteristiċi tal-pinna tiegħek, inkluż kif il-kontatur tad-doża tal-apparat tal-pinna juri n-numru ta' passi tad-doża li għandhom jiġu injettati.
English: • Pharmacists are encouraged to check that patients and carers are able to read the dose counter of the pen device before dispensing the medicine.
Maltese: • L-ispiżjara huma mħeġġa jiċċekkjaw li l-pazjenti u dawk li jieħdu ħsiebhom huma kapaċi jaqraw ilkontatur tad-doża tal-apparat tal-pinna qabel ma jużaw il-mediċina.
English: However, there is a potential risk of patients receiving too little or too much of their medicine because of confusion that may arise over the way the doses are expressed for the individual components − the dose of the insulin is expressed in units while the dose of the non-insulin medicine may be expressed in other units such as mg.
Maltese: Madankollu, hemm ir-riskju potenzjali li l-pazjenti jirċievu ftit wisq jew iżżejjed mill-mediċina tagħhom minħabba konfużjoni li jista' jkun hemm fuq il-mod kif id-dożi huma espressi għallkomponenti individwali − d-doża tal-insulina hija espressa f'unitajiet filwaqt li d-doża tal-mediċina li mhux insulina tista' tiġi espressa f'unitajiet oħra bħal mg.
English: EU Number Invented Name
Maltese: Numru ta' l-UE Isem Kummerċjali
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCE
English: Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l'Agriculture et de la Forêt on 31 March 1992.
Maltese: L-awtorizzazzjoni tal-manifattura ġiet maħruġa mill-Ministère des Affaires Sociales, Ministère délégué à la Santé, u l-Ministère de l'Agriculture et de la Forêt franċiżi fil 31 ta' marzu 1992.
English: ATC vet code: QI09AB02
Maltese: QI09AB02
English: Date of first authorisation: 14/04/2003 Date of last renewal: 11/03/2008
Maltese: Data tal-aħħar tiġdid 11/03/2008
English: Laboratoire Porte des Alpes Rue de l'Aviation
Maltese: Rue de l'Aviation
English: Use sterile syringe and needles.
Maltese: Uża siringi u labar sterilizzati.
English: Adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant
Maltese: F4 (F4ab, F4ac, F4ad), F5, F6, F41
English: Neocolipor suspension for injection
Maltese: Neocolipor suspensjoni għal injezzjoni