FrancophonIA/ELRC3.0 huggingface dataset:
English: An analysis of ADHD inattention and PKU-POMS confusion subscales by change in blood phenylalanine from baseline quartiles showed that patients with the largest phenylalanine reductions experienced the greatest improvements in ADHD inattention and PKU-POMS confusion subscales.
Maltese: F'pazjenti li jkollhom livelli baxxi ta' phenylalanine fid-demm minkejja livelli adegwati ta' konsum tal-proteina, it-tnaqqis fid-doża huwa mistenni li jkun l-aktar effettiv fl-immaniġġjar ta' livelli baxxi ta' phenylalanine fid-demm.
English: The risks associated with adrenaline use should be considered when prescribing Palynziq.
Maltese: Ir-riskji assoċjati mal-użu tal-adrenalina għandhom jiġu kkunsidrati meta tingħata riċetta għal Palynziq.
English: Impact blood phenylalanine reduction on ADHD inattention and PKU-POMS confusion
Maltese: Is-sintomi ta' distrazzjoni u burdata kienu wkoll evalwati matul dan il-perjodu.
English: Serum sickness was most frequent during induction and titration phase (2% of patients; 6 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (0.6% of patients; 1 episode over mean treatment duration of 28 months).
Maltese: Il-mard tas-serum kien l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (2% tal-pazjenti; 6 episodji fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqas fil-fażi tal-manteniment (0.6% tal-pazjenti;
English: Rapid heartbeat
Maltese: F'dan il-fuljett
English: Median protein intake from intact food increased at Month 12 (4 g increase from baseline), and Month 24 (14 g increase from baseline) and Month 36 (25 g increase from baseline).
Maltese: Bidliet fil-konsum tal-proteina minn ikel li mhux mediku maż-żmien Il-konsum medjan tal-proteina minn ikel li mhux mediku żdied f'Xahar 12 (żieda ta' 4 g mil-linja bażi), u Xahar 24 (żieda ta' 14 g mil-linja bażi) u Xahar 36 (żieda ta' 25 g mil-linja bażi).
English: Based on animal studies, hypophenylalaninaemia in pregnant women with PKU treated with Palynziq may be associated with adverse foetal outcomes (see sections 4.6 and 5.3).
Maltese: Abbażi ta' studju fl-annimali, il-livelli baxxi ta' phenylalanine fid-demm f'nisa tqal b'PKU (fenilketonurija) ittrattati b'Palynziq jistgħu jkunu assoċjati ma' riżultati avversi fil-fetu (ara sezzjonijiet 4.6 u 5.3).
English: Common 1 Induction and titration phase reflects the time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose.
Maltese: 1 Il-fażi tal-induzzjoni u t-titrazzjoni tirrifletti ż-żmien qabel ma jintlaħqu l-livelli ta' phenylalanine fid-demm ta' inqas minn 600 micromol/L waqt li fuq doża stabbli.
English: Each pre-filled syringe contains 20 mg pegvaliase in 1 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 20 mg ta' pegvaliase f'soluzzjoni ta' 1 mL.
English: EU/1/19/1362/003 1 x 20 mg pre-filled syringe EU/1/19/1362/004 10 x 20 mg pre-filled syringes
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1362/002 siringa mimlija għal-lest ta' 10 mg
English: PKU-POMS confusion3 subscale (self-rated)
Maltese: Xahar 36 Sottoskala ta' konfużjoni ta' PKU-POMS³ (awto-ikklassifikata) N
English: MA (EU) Number Invented name
Maltese: Numru ta' l-UE Isem kummerċjali
English: Cattle, pigs Subcutaneous use, intramuscular use
Maltese: Speċi li fuqhom għandu jintuża lprodott
English: 1 Leith, R.; Lynch, K.; O'Connell, A. C. (2012): Articaine use in children.
Maltese: 1 Leith, R.; Lynch, K.; O'Connell, A. C.
English: The MAs were granted between 1988 and 2017 with an uneven level of information registered.
Maltese: L-MAs ingħataw bejn l-1988 u l2017 b'livell mhux indaqs ta' informazzjoni rreġistrata.
English: In section 4.9 of the SmPC regarding overdose, two different types are described; absolute and relative overdose.
Maltese: Fis-sezzjoni 4.9 tal-SmPC dwar doża eċċessiva, hemm deskritti żewġ tipi differenti; doża eċċessiva assoluta u relattiva.
English: Sections 2 (qualitative and quantitative composition), 3 (pharmaceutical form), 4.7 (Effects on ability to drive and use machines), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties), 6.1 (list of excipients), 6.2 (incompatibilities), 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) of the SmPC have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template.
Maltese: Sezzjonijiet 2 (għamla kwalitattiva u kwantitattiva), 3 (għamla farmaċewtika), 4.7 (Effetti fuq ilħila biex issuq u tħaddem magni), 5.1 (proprjetajiet farmakodinamiċi), 5.2 (proprjetajiet farmakokinetiċi), 6.1 (lista ta' eċċipjenti), 6.2 (inkompatibbiltajiet), 6.3 (żmien kemm idum tajjeb il-prodott mediċinali), 6.4 (prekawzjonijiet speċjali għall-ħażna), 6.5 (in-natura tal-kontenitur u ta' dak li hemm ġo fih) u 6.6 (Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor) tal-SmPC ġew aġġornati f'konformità mad-dokumentazzjoni tal-Kwalità armonizzata rispettiva tagħhom ipprovduta f'modulu 3 u f'konformità mal-aħħar mudell tal-QRD.
English: Septanest and associated names is authorised in the European Union (EU) in the form of 57 marketing authorisations (MAs); 39 purely national MAs and a Mutual Recognition Procedure (MRP) involving 9 Member States (MS).
Maltese: Septanest u ismijiet assoċjati huwa awtorizzat fl-Unjoni Ewropea (UE) fil-forma ta' 57 awtorizzazzjoni għat-tqegħid fis-suq (MAs); 39 MAs purament nazzjonali u Proċedura ta' Rikonoxximent Reċiproku (MRP) li tinvolvi 9 Stati Membri (MS).
English: The maximum recommended dose of 7 mg/kg of articaine (with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg bodyweight) in dental procedures for paediatric population is in line by the latest recommendations from the American and European Academy of Pediatric Dentistry.
Maltese: Id-doża massima rakkomandata ta' 7 mg/kg ta' articaine (b'doża massima assoluta ta' 385 mg articaine għal wild b'saħħtu ta' 55 kg piż tal-ġisem) fi proċeduri dentali għall-popolazzjoni pedjatrika hija konformi mal-aħħar rakkomandazzjonijiet mill-Akkademija Amerikana u Ewropea tad-Dentistrija Pedjatrika.
English: Articaine inhibits the conduction of nerve impulses by decreasing or blocking sodium (Na+) and potassium (K+) flows during propagation of the nerve action potential.
Maltese: Articaine jinibixxi l-konduzzjoni ta' impulsi tan-nervituri billi jnaqqas jew jimblokka l-flussi ta' sodju (Na+) u potassju (K+) waqt il-propagazzjoni tal-potenzjal tal-azzjoni tan-nerv.
English: A harmonised description of the symptoms and the management of overdose has been agreed.
Maltese: Sar qbil dwar deskrizzjoni armonizzata tas-sintomi u l-ġestjoni ta' doża eċċessiva.
English: Interactions with other medicinal products (section 4.5 of the SmPC) have been summarised in additive interactions with other local anaesthetics, sedatives, halogenated volatile anaesthetics, postganglionic adrenergic blocking agents, non-selective beta-adrenergic blockers, tricyclic antidepressants, catechol-O-methyl transferase inhibitors, drugs causing arrhythmias, ergot-type oxytocic drugs, sympathomimetic vasopressors and phenothiazines.
Maltese: L-interazzjonijiet ma' prodotti mediċinali oħra (sezzjoni 4.5 tal-SmPC) inġabru fil-qosor f'interazzjonijiet addittivi ma' anestetiċi lokali oħrajn, sedattivi, anestetiċi volatili alloġenati, sustanzi tal-imblokk andrenerġiċi postganglijoniċi, imblokkaturi adrenerġiċi tar-riċetturi beta mhux selettivi, antidipressanti triċikliċi, inibituri ta' catechol-O-methyl transferase, mediċini li jikkawżaw arritmiji, mediċini ossitossiċi tat-tip ergotina, vażopressuri simpatomimetiċi u phenothiazines.
English: Other ingredients include sodium metabisulfite, sodium chloride, disodium edetate and sodium hydroxide and water for injection.
Maltese: Sustanzi oħrajn jinkludu sodium metabisulfite, sodium chloride, disodium edetate u sodium hydroxide u ilma għall-injezzjoni.
English: The recommended dose is supported by clinical and literature data.
Maltese: Id-doża rakkomandata hija appoġġata minn data klinika u tal-letteratura.
English: Section 4.2 - Posology and method of administration Posology
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Pożoloġija
English: The updated sections of Module 3 include: Active substance, control of active substance, specification, finished product, description and composition of the finished substance, manufacture, description of manufacturing process and process controls, process validation and/or evaluation, control of excipients, control of finished substance, specifications, analytical procedures, container closure system and stability.
Maltese: Sustanza attiva, kontroll tas-sustanza attiva, speċifikazzjoni, prodott finali, deskrizzjoni u kompożizzjoni tassustanza finali, manifattura, deskrizzjoni tal-proċess ta' manifattura u kontrolli tal-proċess,
English: Septanest and associated names is a fixed-dose combination product containing articaine hydrochloride 40 mg/ml and adrenaline tartrate.
Maltese: Septanest u ismijiet assoċjati huwa prodott ta' kombinazzjoni ta' doża fissa li fih articaine hydrochloride 40 mg/ml u adrenaline tartrate.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data.
Maltese: L-MAH ippropona rakkomandazzjonijiet tad-dożaġġ armonizzati abbażi tad-dożi studjati fi provi kliniċi u appoġġati minn data farmakodinamika u farmakokinetika.
English: It is available in 2 strengths: articaine/adrenaline 40/0.005 mg/ml and articaine/adrenaline 40/0.01 mg/ml.
Maltese: 005 mg/ml u articaine/adrenaline 40/0.
English: Moreover the MAH has submitted bibliographic data from publications regarding the efficacy, safety and pharmacology of articaine 40 mg/mL alone or with adrenaline in dental local anaesthesia.
Maltese: Barra minn hekk, l-MAH ippreżenta data bibliografika minn pubblikazzjonijiet dwar l-effikaċja, is-sigurtà u l-farmakoloġija ta' articaine 40 mg/mL waħdu jew ma' adrenalina f'anesteżija lokali dentali.
English: A crossover, double blind Phase III study, comparing articaine/adrenaline 1:100 000 and 1:200 000, with a total of 11.9 mL (1.7 mL in each of 7 cartridges) of each formulation administered intra-orally to each subject, showed that the difference in adrenaline concentration did not lead to any significant difference in plasma levels of articaine and that no toxicity was observed on patients.
Maltese: III, li jqabbel articaine/adrenaline 1:100 000 u 1:200 000, b'total ta' 11.9 mL (1.7 mL f'kull wieħed mis-7 skrataċ) ta' kull formulazzjoni mogħtija ġol-ħalq lil kull individwu, wera li ddifferenza fil-konċentrazzjoni ta' adrenaline ma wasslitx għal xi differenza sinifikanti fil-livelli ta' articaine fil-plażma u li l-ebda tossiċità ma ġiet osservata fil-pazjenti.
English: Similarly, in a review by Leith and colleagues1, the authors analysed numerous publications employing articaine in children, concluding that 7 mg/kg of articaine is an acceptable maximum dose in a paediatric population.
Maltese: B'mod simili, f'rieżami minn Leith u kollegi1, l-awturi analizzaw bosta pubblikazzjonijiet li jużaw articaine fit-tfal, u kkonkludew li 7 mg/kg ta' articaine hija doża massima aċċettabbli f'popolazzjoni pedjatrika.
English: There was different terminology, used in local SmPCs, regarding the method of administration, aspiration technique, rate of injection and precautions before use.
Maltese: Kien hemm terminoloġija differenti, użata fl-SmPCs lokali, dwar il-metodu ta' mnejn jingħata, teknika ta' aspirazzjoni, rata ta' injezzjoni u prekawzjonijiet qabel l-użu.
English: A harmonised version of section 4.8 of the SmPC regarding adverse events has been agreed by the CHMP after assessing data from the MAH's global pharmacovigilance database and literature data.
Maltese: Sar qbil mis-CHMP dwar verżjoni armonizzata tas-sezzjoni 4.8 tal-SmPC dwar avvenimenti avversi wara li vvaluta data mill-bażi tad-data ta' farmakoviġilanza globali tal-MAH u data tal-letteratura.
English: On 4 June 2018 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Septanest and associated names (see Annex I of CHMP opinion).
Maltese: Fl-4 ta' Ġunju 2018, Septodont, f'isem id-detenturi kollha tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs), ippreżentat lill-Aġenzija Ewropea għall-Mediċini referenza skont l-Artikolu 30 tadDirettiva 2001/83/KE, sabiex jiġu armonizzati s-sommarji tal-karatteristiċi tal-prodott (SmPC) nazzjonali, it-tikkettar, il-fuljett ta' tagħrif u l-Modulu 3 tal-kwalità tal-prodotti mediċinali Septanest u ismijiet assoċjati (ara Anness I tal-opinjoni tas-CHMP).
English: The most important safety concerns are risks related to the central nervous and cardiovascular systems.
Maltese: It-tħassib l-aktar importanti dwar is-sigurtà huwa riskji relatati mas-sistemi nervużi ċentrali u kardjovaskulari.
English: In addition, the MAH made reference to guidelines by the American Academy of Paediatric Dentistry on the use of local anaesthesia for paediatric dental patients (2015) in which articaine 40 mg/mL solution with adrenaline 0.01 mg/mL is listed among the injectable local anaesthetics that can be considered for children.
Maltese: Barra minn hekk, l-MAH għamel referenza għal-linji gwida mill-Akkademija Amerikana tad-Dentistrija Pedjatrika dwar l-użu ta' anesteżija lokali għal pazjenti dentali pedjatriċi (2015) li fihom articaine 40 mg/mL soluzzjoni ma' adrenaline 0.01 mg/mL hija elenkata fost l-anestetiċi lokali injettabbli li jistgħu jiġu kkunsidrati għat-tfal.
English: The section 4.4 of the SmPC (Warnings) has been summarized to include the below categories: patients with cardiovascular disorders, epileptic patients, patients with plasma cholinesterase deficiency, patients with renal disease, patients with severe hepatic disease, patients with myasthenia gravis treated by acetylcholinesterase inhibitors, patients with porphyria, patients with concomitant treatment with halogenated inhalation anaesthetics, patients receiving treatment with antiplatelets / anticoagulants and elderly patients.
Maltese: Is-sezzjoni 4.4 tal-SmPC (Twissijiet) inġabret fil-qosor biex tinkludi l-kategoriji ta' hawn taħt: pazjenti b'disturbi kardjovaskulari, pazjenti epilettiċi, pazjenti b'defiċjenza ta' kolinesterasi talplażma, pazjenti b'mard tal-kliewi, pazjenti b'mard sever tal-fwied, pazjenti b'mijastenija gravi kkurati b'inibituri ta' acetylcholinesterase, pazjenti b'porfirija, pazjenti b'kura konkomitanti ma' anestetiċi ta' inalazzjoni alloġenta, pazjenti li jirċievu kura b'antipjastrini / antikoagulanti u pazjenti anzjani.
English: The doses recommended in various national SmPCs vary per indication and population group (adults, children and special population).
Maltese: Id-dożi rakkomandati f'diversi SmPCs nazzjonali jvarjaw skont l-indikazzjoni u l-grupp tal-popolazzjoni (adulti, tfal u popolazzjoni speċjali).
English: The content of up one cartridge of articaine is usually sufficient.
Maltese: Il-kontenut ta' sa skartoċċ wieħed ta' articaine normalment ikun biżżejjed.
English: Septanest and associated names is indicated for the local and loco-regional anaesthesia in dental procedures in adults, adolescents and children above 4 years of age [or from 20 kg (44lbs) of body weight].
Maltese: Septanest u ismijiet assoċjati huwa indikat għall-anesteżija lokali u loko-reġjonali fi proċeduri dentali f'adulti, fl-adolexxenti u fit-tfal minn età ta' aktar minn 4 snin [jew minn 20 kg (44lbs) talpiż tal-ġisem].
English: The finished product is presented as a solution for injection containing articaine hydrochloride 40 mg/ml and adrenaline tartrate in 2 strengths: articaine/adrenaline 40/0.005 mg/ml and articaine/adrenaline 40/0.01 mg/ml.
Maltese: Il-prodott finali huwa ppreżentat bħala soluzzjoni għall-injezzjoni li fiha articaine hydrochloride 40 mg/ml u adrenaline tartrate f'2 qawwiet: articaine/adrenaline 40/0.
English: Data obtained after intraoral administration of articaine 40 mg/mL with adrenaline 0.01 mg/mL at the maximum recommended dose for articaine showed that the maximum therapeutic dose of 500 mg does not produce signs of intoxication (cardiovascular issues) in healthy patients.
Maltese: Data miksuba wara għoti ġol-ħalq ta' articaine 40 mg/mL ma' adrenaline 0.01 mg/mL bid-doża massima rakkomandata għal articaine wriet li d-doża terapewtika massima ta' 500 mg ma tipproduċix sinjali ta' intossikazzjoni (problemi kardjovaskulari) f'pazjenti b'saħħithom.
English: The CHMP did not endorse the omission of the wording regarding avoidance of administration into inflamed or infected tissues as injection of local anaesthetics into such tissues may result in decreased effectiveness of the anaesthetics.
Maltese: Is-CHMP ma approvax ittneħħija tal-formulazzjoni dwar l-evitar ta' għoti f'tessut infjammat jew infettat peress li injezzjoni ta' anestetiċi lokali f'tessut bħal dan tista' tirriżulta f'effettività mnaqqsa tal-anestetiċi.
English: For routine dental procedures in adults the lowest dose leading to effective anaesthesia should be used.
Maltese: Għal proċeduri dentali ta' rutina f'adulti, għandha tintuża d-doża l-aktar baxxa li twassal għal anesteżija effettiva.
English: The results of these studies indicate that articaine 40 mg/mL with 0.01 mg/mL or with 0.005 mg/mL adrenaline is effective as a local dental anaesthetic in adults and children above 4 years old.
Maltese: Ir-riżultati ta' dawn l-istudji jindikaw li articaine 40 mg/mL ma' 0.01 mg/mL jew ma' 0.005 mg/mL adrenaline huwa effettiv daqs anestetiku dentali lokali f'adulti u fit-tfal ta' aktar minn 4 snin.
English: The data supporting contraindications included in section 4.3 of the SmPC was discussed by the MAHs and the rationale provided for keeping them in the SmPC was agreed by the CHMP for patients with a
Maltese: Id-data li tappoġġa l-kontraindikazzjonijiet inklużi fis-sezzjoni 4.3 tal-SmPC ġiet diskussa mill-MAHs u r-raġunament ipprovdut biex jinżammu fl-SmPC sar qbil dwaru mis-CHMP għal pazjenti bi storja
English: The CHMP considered that information about usual doses is important to prevent misinterpretation of dosing recommendations and usage of only maximum doses.
Maltese: Is-CHMP qies li informazzjoni dwar dożi tas-soltu hija importanti biex tipprevjeni misinterpretazzjoni ta' rakkomandazzjonijiet tad-dożaġġ u użu ta' dożi massimi biss.
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6 of the SmPC) with data supported from pre-clinical studies, rejecting detailed information regarding the preclinical studies that did not provide valuable information for healthcare professionals.
Maltese: Is-CHMP qabel dwar frażijiet komuni, dwar il-fertilità, tqala u treddigħ (sezzjoni 4.6 tal-SmPC) dwar data appoġġata minn studji prekliniċi, li jirrifjutaw informazzjoni dettaljata dwar l-istudji prekliniċi li ma pprovdewx informazzjoni importanti għall-professjonisti fil-qasam tal-kura tas-saħħa.
English: In conclusion, based on the assessment of the Marketing Authorisation Holder's proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised wording of product information and quality documentation for Septanest and associated names.
Maltese: Bħala konklużjoni, abbażi tal-valutazzjoni tal-proposti u r-risponsi tad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u wara d-diskussjonijiet tal-Kumitat, is-CHMP adotta formulazzjoni armonizzata ta' informazzjoni dwar il-prodott u dokumentazzjoni tal-kwalità għal Septanest u ismijiet assoċjati.
English: The vasoconstrictor decreases the vascular perfusion at the site of injection and consequently it reduces the rate of absorption of the anaesthetic into the circulation.
Maltese: Il-vażokostrittur inaqqas il-perfużjoni vaskulari fis-sit tal-injezzjoni u konsegwentement inaqqas ir-rata ta' assorbiment tal-anestetiku fiċ-ċirkolazzjoni.
English: In the subsection precautions for use, precautions are included for risk associated with accidental intravascular injection and risk associated with intraneural injection.
Maltese: Fis-subsezzjoni prekawzjonijiet għall-użu, il-prekawzjonijiet huma inklużi għal riskju assoċjat ma' injezzjoni intravaskulari aċċidentali u riskju assoċjat ma' injezzjoni intranewrali.
English: The package leaflet (PL) was amended in accordance with the changes made to the SmPC.
Maltese: Il-fuljett ta' tagħrif (PL) ġie emendat f'konformità mal-bidliet proposti għall-SmPC.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC for the harmonisation of the product information as requested by the Marketing Authorisation Holder;
Maltese: • Il-Kumitat ikkunsidra r-referenza skont l-Artikolu 30 tad-Direttiva 2001/83/KE għallarmonizzazzjoni tal-informazzjoni dwar il-prodott kif mitlub mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq;
English: • The Committee considered the harmonised product information and Quality documentation (Module 3) for Septanest and associated names to be acceptable; The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Septanest and associated names (see Annex I).
Maltese: • Il-Kumitat ikkunsidra l-informazzjoni dwar il-prodott armonizzata u dokumentazzjoni dwar il-Kwalità (Modulu 3) għal Septanest u ismijiet assoċjati bħala aċċettabbli;
English: An excessive plasma concentration of articaine may result in cardiovascular toxicity, while high levels of adrenaline in the blood may lead to cardiovascular stimulation.
Maltese: Konċentrazzjoni eċċessiva ta' articaine fil-plażma tista' tirriżulta f'tossiċità kardjovaskulari, filwaqt li livelli għoljin ta' adrenaline fid-demm jistgħu jwasslu għal stimulazzjoni kardjovaskulari.
English: The dose should be calculated according to the patient's bodyweight and the total dose for all injected sites should not exceed the maximum recommended dose of 7.0 mg per kg of bodyweight with an absolute maximum recommended dose of 500 mg.
Maltese: Id-doża għandha tiġi kkalkulata skont il-piż tal-ġisem tal-pazjent u d-doża totali għas-siti injettati kollha m'għandhiex taqbeż id-doża massima rakkomandata ta' 7.0 mg għal kull kg tal-piż tal-ġisem b'doża massima assoluta rakkomandata ta' 500 mg.
English: Ref. EMEA/32706/2007 for pandemic):
Maltese: EMEA/32706/2007 għall-pandemija):
English: Day 180
Maltese: Ġurnata 180
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Maltese: Kontra A/Indonesia 21 ġurnata wara boosting b'A/Indonesia N=49
English: Pumarix contains thiomersal
Maltese: Pumarix fih thiomersal
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Maltese: Vaċċini tal-influwenza, Kodiċi ATC J07BB02.
English: Adverse Events of Special Interest (PTs)
Maltese: Avvenimenti Avversi ta' Interess Speċjali (PTs)
English: Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports
Maltese: Reazzjonijiet fatali u/jew ta' periklu għall-ħajja - għal kull Terminu Preferut (PT), inkluż il proporzjon ta' rapporti fatali
English: For further information, see section 5.1.
Maltese: Għal aktar informazzjoni, ara sezzjoni 5.1.
English: - Report submission is no later than day 22 (i.e. the following Monday).
Maltese: - Sottomissjoni tar-rapport iseħħ mhux aktar tard minn ġurnata 22 (i.e. it-Tnejn ta' wara).
English: Immune response to A/Vietnam/1194/2004
Maltese: Rispons immuni għal A/Vietnam/1194/2004
English: See sections 4.8
Maltese: Ara sezzjonijiet 4.8 u 5
English: All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years
Maltese: L-avvenimenti kollha li seħħew fil-gruppi ta' età li ġejjin: 6-23 xahar, 2-8 snin, 8-17-il sena,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 March 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 4 ta' Marzu 2011
English: Serious unexpected reactions (PTs)
Maltese: Reazzjonijiet serji mhux mistennija (PTs)