FrancophonIA/ELRC3.0 huggingface dataset:
English: Review of systemic formulation of nimesulide-containing medicines, following the suspension of the marketing authorisation for these medicines in Ireland due to concerns over serious liver problems.
Maltese: • Reviżjoni ta' formulazzjoni sistemika ta' mediċini li jinkludu nimesulide, wara s-sospensjoni ta' l-awtorizzazzjoni għat-tqegħid fis-suq għal dawn il-mediċini fl-Irlanda minħabba tħassib dwar problemi tal-fwied serji.
English: 4.3 Sampling and testing
Maltese: 4.3 Teħid ta' kampjuni u ttestjar
English: The new features include advanced search for product information in a number of EU languages (being tested), a new sitemap offering improved navigation, and the inclusion of maximum residue limit (MRL) information for veterinary medicines.
Maltese: Il-fatturi l-ġodda jinkludu tiftix avvanzat għal informazzjoni dwar il-prodotti f'numru ta' lingwi ta' l-UE (li qiegħed jiġi ttestjat), mappa tas-sit ġdida li toffri navigazzjoni mtejba, u l-inklużjoni ta' informazzjoni dwar limiti massimi ta' residwi (MRL) għal mediċini veterinarji.
English: Referral procedures concluded in 2007
Maltese: Proċeduri ta' referenza konklużi fl-2007
English: New indications were also approved in the fields of cardiovascular, infectious, rheumatoid and inflammatory-bowel diseases and central-nervous-system disorders.
Maltese: • Kienu approvati wkoll indikazzjonijiet ġodda fl-oqsma ta' mard kardjovaskulari, infettiv, rewmatojde u infjammatorju tal-musrana u ta' disturbi tas-sistema nervuża ċentrali.
English: For the treatment of bronchitis, sinusitis and tonsillitis/pharyngitis, Ketek should only be used for infections caused by bacterial strains that are suspected or proven to be resistant to, or cannot be treated with, macrolide or beta-lactam antibiotics.
Maltese: Għall-kura tal-bronkite, sinusite u tonsillite/farinġite, Ketek għandu jintuża biss għal infezzjonijiet ikkawżati minn tipi ta' batterji li huma suspettati jew ipprovati li huma reżistenti għal, jew li ma jistgħux jiġu kkurati bi, l-antibijotiċi macrolide jew beta-lactam.
English: Review of lumiracoxib-containing medicines, intended for the treatment of osteoarthritis, further to notification by the UK, which was considering the suspension of the marketing authorisation due to possible increased risk of hepatotoxic adverse events at the 100mg dose.
Maltese: • Reviżjoni tal-mediċini li jinkludu lumiracoxib, intenzjonati għall-kura ta' l-osteoartrite, wara notifika mir-Renju Unit, li kien qed jikkunsidra s-sospensjoni ta' l-awtorizzazzjoni għat-tqegħid fis-suq minħabba riskju possibbli ta' żieda ta' avvenimenti avversi epatotossiċi bid-doża ta' 100mg.
English: It blocks the activity of renin, an enzyme which is involved in the production of angiotensin I that is subsequently converted into the hormone angiotensin II, a powerful vasoconstrictor (it narrows blood vessels and consequently raises the blood pressure).
Maltese: Huwa jwaqqaf l-attività tarrenin, enzim li huwa involut fil-produzzjoni ta' l-anġotensin I li huwa sussegwentement maqlub flormon anġotensin II, vażokostrittur qawwi ħafna (huwa jraqqaq l-arterji u l-vini u konsegwentement iżid il-pressjoni tad-demm).
English: All variation applications were evaluated within the regulatory time limits.
Maltese: Il-varjazzjoni ta' l-applikazzjonijiet kollha ġiet evalwata fil-limiti ta' żmien regolatorji.
English: Review of carisoprodol, following the plan to withdraw the marketing authorisation for this medicine in Norway due to risks of intoxication, psychomotor impairment, addiction and misuse due to offlabel prescribing.
Maltese: • Reviżjoni ta' carisoprodol, wara l-pjan għall-irtirar ta' l-awtorizzazzjoni għat-tqegħid fis-suq għal din il-mediċina fin-Norveġja minħabba riskji ta' intossikazzjoni, impediment psikomotorju, dipendenza u użu żbaljat minħabba preskrizzjonijiet mhux skond it-tikketta.
English: The PDCO held its first meeting on 4-5 July 2007.
Maltese: Il-PDCO kellu l-ewwel laqgħa tiegħu fl-4-5 ta' Lulju 2007.
English: The CVMP completed the assessment and issued opinions on 3 of the referral procedures started in 2007 and on 7 of the referral procedures started in 2006.
Maltese: Il-CVMP iffinalizza l-valutazzjoni u ħareġ opinjonijiet dwar 3 mill-proċeduri ta' referenza mibdijin fl2007 u dwar 7 mill-proċeduri ta' referenza mibdijin fl-2006.
English: The CHMP concluded the risks of these medicines outweigh their benefits and recommended the suspension of the marketing authorisations (Article 107(2) procedure).
Maltese: Is-CHMP ikkonkluda li r-riskji ta' dawn il-mediċini jegħlbu l-benefiċċji tagħhom u rrakkomanda s-sospensjoni ta' lawtorizzazzjonijiet għat-tqegħid fis-suq (proċedura ta' l-Artikolu 107(2)).
English: Cardiovascular and respiratory
Maltese: Kardjo vaskulari u respirato rju
English: Porcine circovirus is involved in the aetiology of porcine multisystemic wasting syndrome (PMWS), which is considered one of the most significant challenges facing the pig industry in the EU, and the authorisation of these products should assist with control of this disease;
Maltese: Iċ-ċirkovirus tal-ħnieżer huwa involut fl-etjoloġija tal-porcine multisystemic wasting syndrome (PMWS), li hija meqjusa bħala waħda mill-isfidi l-aktar sinjifikanti li qegħda taffaċċja l-industrija tal-majjali fl-UE, u lawtorizzazzjoni ta' dawn il-prodotti għandha tassisti l-kontroll ta' din il-marda;
English: EU and non-EU ADR reports transmitted to the EMEA
Maltese: Rapporti ADR mill-UE u minn barra l-UE mibghuta lill-EMEA
English: Type-I variation notifications Type-II variation opinions Line-extension opinions
Maltese: Konsultazzjoni dwar l-esperjenza bid-direttiva dwar il-mediċini mill-ħxejjex
English: Review of mifepristone-containing medicines, following safety and efficacy concerns regarding the use of the approved 600mg dose of mifepristone, as compared to the use of a 200mg dose, in the medical termination of developing intra-uterine pregnancy in sequential use with prostaglandin analogue.
Maltese: • Reviżjoni ta' mediċini li fihom mifepristone, wara tħassib dwar is-sigurtà u l-effikaċja rigward lużu tad-doża ta' 600mg ta' mifepristone approvata, meta mqabbla ma' doża ta' 200mg, fitterminazzjoni medika ta' l-iżvilupp ta' tqala fl-utru fl-użu sekwenzjali ma' analogu ta' prostaglandin.
English: The Agency participated in the preparation of the action plan, released in August 2007, for implementation of the Strategic Research Agenda.
Maltese: L-Aġenzija pparteċipat filpreparazzjoni ta' pjan ta' azzjoni, li nħareġ f'Awwissu 2007, għall-implimentazzjoni ta' l-Aġenda għar-Riċerka Strateġika.
English: Review of veralipride-containing medicines, following the withdrawal of veralipride form the Spanish market because of reports of serious side effects affecting the nervous system and a number of regulatory actions in other EU Member States where veralipride was authorised.
Maltese: • Reviżjoni tal-mediċini li jinkludu veralipride, wara l-irtirar tal-veralipride mis-suq Spanjol minħabba rapporti ta' effetti sekondarji serji li jaffettwaw is-sistema nervuża u numru ta' azzjonijiet regolatorji fi Stati Membri ta' l-UE oħrajn fejn il-veralipride hija awtorizzata.
English: Continuing high priority was given to the authorisation of vaccines against avian influenza in chickens, because control of the disease in chickens reduces the likelihood of a pandemic developing through transfer of the virus from birds to man.
Maltese: Ingħatat prijorità għolja kontinwa lill-awtorizzazzjoni ta' tilqim kontra l-influwenza avjarja fit-tiġieġ, għaliex il-kontroll tal-marda fit-tiġieġ inaqqas il-probabbiltà li tiżviluppa pandemija permezz tattrasferiment tal-virus mit-tjur għall-bniedem.
English: The development of recommendations of the EMEA/CHMP Working Group with Healthcare Professionals (HCP WG) started in 2007.
Maltese: Il-livelli ta' attività f'dawn l-oqsma żdiedu mill-ġdid fl-2007 (ara l-kapitolu 2).
English: These systems are evolving in line with communicated requirements.
Maltese: Tul ta' zmien medju ta' proceduri ta' parir xjentifiku f'jiem
English: One positive opinion related to the establishment of final MRLs further to previous provisional MRLs for a new substance.
Maltese: MRLs provviżorji preċedenti għal sustanza ġdida.
English: A status report on the progress of the implementation plan for the framework of interaction with patients and consumers was presented to the Patients' and Consumers' Working Party (PCWP) during its December 2007 meeting.
Maltese: Rapport dwar l-istatus ta' progress tal-pjan ta' implimentazzjoni għall-qafas ta' interazzjoni malpazjenti u mal-konsumaturi kien ippreżentat lill-Grupp ta' Ħidma tal-Pazjenti u l-Konsumaturi (PCWP) waqt il-laqgħa tiegħu f'Diċembru 2007.
English: The CHMP recommended new contra-indications for 20 centrally authorised medicines, and in some instances for the entire classes of centrally authorised medicines (class labelling), including: Viracept (nelfinavir mesilate): co-administration with omeprazole;
Maltese: Is-CHMP irrakkomanda kontro-indikazzjonijiet ġodda għal 20 mediċina awtorizzata ċentralment, u f'xi każi għall-klassijiet kollha ta' mediċini awtorizzati ċentralment (ittikkettjar skond il-klassi), li jinkludu:
English: 2007 milestones
Maltese: Opinjonijiet adottati fl-2007
English: Expedited reports on suspended adverse reactions
Maltese: Awtorizzazzjonijiet ghat-tqeghid fis-suq Ghajnuna ghall-protokoll Spezzjonijiet
English: Forty percent of ADR reports received related to centrally authorised medicines.
Maltese: Erbgħin fil-mija tar-rapporti ADR riċevuti kienu relatati ma' mediċini awtorizzati ċentralment.
English: Of the 8 pharmaceutical applications, 1 was a generic application.
Maltese: Mit-8 applikazzjonijiet farmaċewtiċi, waħda kienet applikazzjoni ġenerika.
English: The number of training days taken by EMEA staff was up by almost 30% on the previous year, reaching a total of 4,166 days.
Maltese: In-numru ta' ġranet ta' taħriġ għallpersunal ta' l-EMEA żdied bi kważi 30% fuq is-sena preċedenti, u laħaq it-total ta' 4,166 jum.
English: The number of withdrawn applications - 19 - was the lowest in the past seven years.
Maltese: In-numru ta' applikazzjonijiet irtirati - 19 - kien laktar wieħed baxx fl-aħħar seba' snin.
English: Perhaps the most tangible and significant achievement of 2007 was the Agency's successful introduction of new procedures and creation of a new scientific committee dedicated to implementing the EU's Paediatric Regulation, which came into force on 26 January 2007.
Maltese: Forsi l-aktar kisba tanġibbli u sinifikanti ta' l-2007 kienet l-introduzzjoni b'suċċess mill-Aġenzija ta' proċeduri ġodda u l-ħolqien ta' kumitat xjentifiku ġdid iddedikat għall-implimentazzjoni tarRegolament pedjatriku ta' l-UE, li daħal fis-seħħ fis-26 ta' Jannar 2007.
English: A designated orphan medicinal product intended to reduce haemolysis (destruction of red blood cells) in patients with paroxysmal nocturnal haemoglobinuria (PNH) - a rare blood disorder in which the red blood cells are destroyed more rapidly than normal, causing the urine to turn dark.
Maltese: • Prodott mediċinali kklassifikat bħala orfni maħsub biex inaqqas l-emolożi (distruzzjoni taċ-ċelloli ħomor tad-demm) f'pazjenti b'paroxysmal nocturnal haemoglobinuria (PNH) - marda rari fiddemm fejn iċ-ċelloli ħomor tad-demm jinqerdu aktar malajr mis-soltu u tiskura l-urina.
English: New applications for maximum residue limits
Maltese: Applikazzjonijiet godda ghal limiti massimi ta' residwi
English: I would like to express my deep gratitude, and that of the entire network, to Hannes for his important contribution, which is greatly appreciated.
Maltese: Nixtieq nesprimi l-gratitudni kbira tiegħi, u dik tan-network kollu, lil Hannes għall-kontribut importanti tiegħu, li huwa apprezzat bil-kbir.
English: An important indicator of the EMEA's activity during any year is the number of applications it receives and processes for the initial marketing authorisation of medicines.
Maltese: Indikatur importanti ta' l-attività ta' l-EMEA f'kwalunkwe sena huwa n-numru ta' applikazzjonijiet li hija tirċievi u tipproċessa għall-awtorizzazzjoni għal tqegħid fis-suq inizjali ta' mediċini.
English: The CHMP restricted the indication for a number of medicines for efficacy or safety reasons, including:
Maltese: Is-CHMP għamel restrizzjoni fuq l-indikazzjoni għal numru ta' mediċini għal raġunijiet ta' effikaċja jew sigurtà, inklużi:
English: With the support of the national competent authorities the Agency succeeded in establishing the Paediatric Committee (PDCO) - the Agency's fifth scientific committee - and putting in place the necessary procedures for the assessment of paediatric investigation plans (PIPs) and waiver applications.
Maltese: Bl-appoġġ ta' l-awtoritajiet kompetenti nazzjonali l-Aġenzija rnexxielha twaqqaf il-Kumitat Pedjatriku (PDCO) - il-ħames kumitat xjentifiku ta' l-Aġenzija - u l-preparazzjoni tal-proċeduri meħtieġa għall-valutazzjoni ta' applikazzjonijiet għal pjanijiet ta' investigazzjonijiet pedjatriċi (PIPs) u dispensi.
English: The Agency provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.
Maltese: L-Aġenzija tipprovdi lill-Istati Membri u lill-istituzzjonijiet ta' l-UE bl-aħjar parir xjentifiku possibbli dwar kwalunkwe kwistjoni marbuta mal-valutazzjoni tal-kwalità, is-sigurtà u l-effikaċja ta' prodotti mediċinali għall-użu tal-bniedem u veterinarju riferuti lilha skond id-dispożizzjonijiet tal-leġiżlazzjoni ta' l-UE relatatai mal-prodotti mediċinali.
English: The CHMP concluded that the benefit-risk of nimesulide continues to be positive and recommended the maintenance of the marketing authorisation but with a restricted use (Article 107(2) procedure).
Maltese: Is-CHMP ikkonkluda li l-benefiċċju-riskju tan-nimesulide għadu pożittiv u rrakkomanda ż-żamma ta' l-awtorizzazzjoni għat-tqegħid fis-suq iżda b'użu ristrett (proċedura ta' l-Artikolu 107(2)).
English: Company clock-stop
Maltese: Decizjonijiet tal-Kummissjoni
English: January 1998
Maltese: Jannar 1998
English: Length Adequate for Delivery of Epinephrine Intramuscularly?
Maltese: Adequate for Delivery of Epinephrine Intramuscularly?
English: Epinephrine Auto-injectors: Is Needle
Maltese: Epinephrine Auto-injectors: Is Needle Length
English: Frey, M.R. Reichenbach, and S.T. Wilber, Predictors of epinephrine autoinjector needle length inadequacy.
Maltese: Reichenbach, u S.T. Wilber, Predictors of epinephrine autoinjector needle length inadequacy.
English: 1 F. Estelle R. Simons, MD, FRCPC, Janet R Roberts, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD. Epinephrine absorption in children with a history of anaphylaxis.
Maltese: 1 F. Estelle R. Simons, MD, FRCPC, Janet R Roberts, MD, FRCPC, Xiaochen Gu, PhD, u Keith J. Simons, PhD. Epinephrine absorption in children with a history of anaphylaxis.
English: Ann Allergy Asthma Immunol 2005;94:539-542 4 Dawn Stecher, Blake Bulloch, Justin Sales, Carrie Schaefer and Laine Keahey.
Maltese: 39-542 4 Dawn Stecher, Blake Bulloch, Justin Sales, Carrie Schaefer u Laine Keahey.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for adrenaline auto-injectors.
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-injetturi awtomatiċi tal-adrenalina.
English: Daniel C. Bewick, MD, Neville B. Wright, MD, Richard S. Pumphrey, MD, Peter D. Arkwright, MD, DPhil.
Maltese: Pumphrey, MD, Peter D. Arkwright, MD, DPhil.
English: The main clinical data available focus on demonstrating the skin-to-muscle depth (STMD) in adults and children and the CHMP noted that there is inconsistency across the studies with some finding no correlation between STMD and Body Mass Index (BMI) or weight (Song (2005)3, Stecher (2009)4) and others finding a correlation (Bhalla (2013)5, Bewick (2013)6).
Maltese: Id-dejta klinika ewlenija disponibbli hija ffukata fuq li turi l-fond mill-ġilda sal-muskolu (STMD) fl-adulti u t-tfal u s-CHMP innota li hemm inkonsistenza bejn l-istudji b'xi wħud ma jsibu l-ebda korrelazzjoni bejn STMD u l-Indiċi tal-Massa tal-Ġisem (BMI) jew il-piż (Song (2005)3, Stecher (2009)4) u oħrajn li jsibu korrelazzjoni (Bhalla (2013)5, Bewick (2013)6).
English: 2 F. Estelle R. Simons, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD. Epinephrine absorption in adults:
Maltese: 2 F. Estelle R. Simons, MD, FRCPC, Xiaochen Gu, PhD, u Keith J. Simons, PhD.
English: Bhalla, M.C., B.D.
Maltese: Bhalla, M.C., B.D. Gable, J.A. Frey, M.R.
English: The matter was then referred to the Committee for Medicinal Products for Human Use (CHMP) for a review under Article 31 of Directive 2001/83/EC.
Maltese: Il-kwistjoni ġiet riferuta lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) għal reviżjoni skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Clinical Communication 7 Brown J, Tuthill D, Alfaham M et al. (2013) A randomised maternal evaluation of epinephrine autoinjection devices.
Maltese: Clinical Communication 7 Brown J, Tuthill D, Alfaham M et al.
English: The CHMP acknowledged that patient/carer compliance with the use of the auto-injectors is also very important as evidenced by the study by Brown J et al (2015)7.
Maltese: Is-CHMP irrikkonoxxa li l-konformità tal-pazjent/min jieħu ħsiebu mal-użu tal-injetturi awtomatiċi hija wkoll importanti ħafna kif evidenzjat mill-istudju ta' Brown J et al (2015)7.
English: The CHMP noted the lack of clinical evidence from randomised, controlled trials, due to the logistical and ethical problems involved with conducting such trials in emergency situations, particularly with a placebo control.
Maltese: Is-CHMP innota n-nuqqas ta' evidenza klinika minn provi kliniċi kkontrollati u randomizzati minħabba lproblemi loġistiċi u etiċi involuti fit-twettiq ta' tali provi f'sitwazzjonijiet ta' emerġenza, b'mod partikolari b'kontroll bi plaċebo.
English: Published clinical data indicate that the rate of absorption is prolonged if the adrenaline is delivered subcutaneously (SC).
Maltese: Dejta klinika ppubblikata tindika li r-rata ta' assorbiment hija mtawla jekk l-adrenalina tingħata taħt il-ġilda (SC).
English: Results from PK studies (Simons, 19981, 20012) support the guidelines recommendation (e.g. UK Resuscitation Guideline) that an intramuscular injection is the preferred route of administration in the treatment of anaphylaxis as a rapid response is important in ensuring a non-fatal outcome.
Maltese: Ir-riżultati mill-istudji PK (Simons, 19981, 20012) jappoġġjaw ir-rakkomandazzjonijiet tal-linji gwida (eż. Linja Gwida għar-Risuxxitazzjoni tar-Renju Unit) li injezzjoni ġol-muskolu hija l-mod preferut ta'
English: The experts consulted unanimously agreed that a PK study in humans would be useful in order to gain information on the optimum parameters of administration; the group also noted the possibility to collect PD data in this same study.
Maltese: L-esperti kkonsultati unanimament qablu li studju PK fil-bnedmin ikun utli sabiex tinkiseb informazzjoni dwar l-aħjar parametri għall-għoti; il-grupp innota wkoll il-possibbiltà li tinġabar dejta PD fl-istess studju.
English: The first adrenaline auto-injectors (AAI) were developed and introduced into the medical market approximately 25 years ago in the USA.
Maltese: L-ewwel injetturi awtomatiċi tal-adrenalina (AAI) kienu żviluppati u introdotti fis-suq mediku madwar 25 sena ilu fl-Istati Uniti.
English: • The CHMP considered the totality of the available non-clinical and clinical data to inform whether adrenaline administered via an auto-injector is delivered intramuscularly or subcutaneously, including submissions by marketing authorisation holders, consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: • Is-CHMP ikkunsidra d-dejta klinika u mhux klinika kollha disponibbli biex jinforma jekk ladrenalina mogħtija permezz ta' injettur awtomatiku tingħatax ġol-muskolu jew taħt il-ġilda, inkluż is-sottomissjonijiet mid-detenturi tal-awtorizzazzjonijiet għat-tqegħid fis-suq, ilkonsultazzjonijiet mal-professjonisti fil-kura tas-saħħa, l-esperti u l-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza (PRAC).
English: Furthermore, the CHMP imposed a PK/PD study in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device and encouraged the possibility for a study to assess the effectiveness of the proposed risk minimisation measures and the conduct of an observational study to assess usage and incidence of lack of efficacy and device failure.
Maltese: Barra minn hekk, is-CHMP impona studju PK/PD sabiex jifhem l-influwenza tal-fatturi differenti fuq iddistribuzzjoni, l-espożizzjoni u l-attività tal-adrenalina meta tingħata permezz ta' apparat b'injettur awtomatiku tal-adrenalina u ħeġġeġ l-possibbiltà għal studju biex tiġi vvalutata l-effikaċja tal-miżuri ta' minimizzazzjoni tar-riskju proposti u t-twettiq ta' studju osservazzjoni biex jiġi vvalutat l-użu u linċidenza ta' nuqqas ta' effikaċja u ta' ħsara fl-apparat.
English: The needle length is another factor and the UK Resuscitation Council Guidelines do suggest a 25mm needle is optimal for intramuscular injection; however the CHMP noted that these guidelines are written for use in the hospital setting where healthcare professionals will generally inject the adrenaline using a manual needle and syringe, not an auto-injector.
Maltese: It-tul tal-labra huwa fattur ieħor u l-Linji Gwida tal-Kunsill tar-Risuxxitazzjoni tar-Renju Unit jissuġġerixxu li labra ta' 25 mm hija ottimali għal injezzjoni ġol-muskolu; madankollu s-CHMP innota li dawn il-linji gwida huma miktubin għall-użu fi sptar fejn il-professjonisti fil-kura tas-saħħa ġeneralment jinjettaw l-adrenalina permezz ta' labra u siringa manwali, mhux b'injettur awtomatiku.
English: The CHMP also recommended further risk minimisation measures, including educational materials, to be submitted and agreed via risk management plans.
Maltese: Is-CHMP irrakkomanda wkoll miżuri oħrajn ta' minimizzazzjoni tar-riskju, inkluż materjal edukattiv, li għandhom jiġu sottomessi u jintlaħaq qbil dwarhom permezz ta' pjanijiet ta' ġestjoni tar-riskju.
English: Adrenaline auto-injectors are indicated in the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis.
Maltese: L-injetturi awtomatiċi tal-adrenalina huma indikati fil-kura ta' emerġenza ta' reazzjonijiet allerġiċi severi (anafilassi) pereżempju għal tingiż jew gdim tal-insetti, ikel, mediċini u allerġeni oħrajn kif ukoll anafilassi idjopatika jew ikkawżata mill-eżerċizzju.
English: The CHMP also concluded on the need for a PK/PD study to be conducted in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device.
Maltese: mifhuma l-influwenza ta' fatturi differenti fuq id-distribuzzjoni, l-espożizzjoni u l-attività tal-adrenalina meta tingħata permezz ta' strument ta' injezzjoni awtomatika tal-adrenalina jistgħu jiġu kkunsidrati.
English: The fact that 15% of mothers were unable to ‘fire' the auto-injector successfully supports that patients' training tools need to be improved and that training needs to be repeated at regular intervals.
Maltese: Il-fatt li 15% tal-ommijiet ma rnexxilhomx iħaddmu l-injettur awtomatiku jappoġġja l-ħtieġa ta' titjib fl-għodod ta' taħriġ talpazjenti u li t-taħriġ jeħtieġ li jiġi ripetut f'intervalli regolari.
English: Auto-injectors were invented in the 1960s following military research in the United States of America (USA).
Maltese: L-injetturi awtomatiċi ġew ivvintati fis-sittinijiet wara riċerka militari fl-Istati Uniti tal-Amerka (USA).