FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Aripiprazole Mylan?
Maltese: X'inhu Aripiprazole Mylan?
English: It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder.
Maltese: Huwa kien mistenni wkoll li jintuża għall-kura ta' episodji manijakali moderati sa severi u għallprevenzjoni ta' episodji manijakali ġodda f'persuni adulti b'disturb bipolari I li jkunu rrispondew għallmediċina fil-passat, u għal massimu ta' 12-il ġimgħa għall-kura ta' episodji manijakali moderati sa severi f'pazjenti b'disturb bipolari I ta' età minn 13-il sena 'l fuq.
English: Aripiprazole Mylan is a medicine that contains the active substance aripiprazole.
Maltese: Aripiprazole Mylan huwa mediċina li fiha s-sustanza attiva aripiprażol.
English: The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Aripiprazole Mylan, aripiprazole, hija mediċina antipsikotika.
English: The company informed the CHMP that there were no consequences for patients in clinical trials.
Maltese: Il-kumpanija informat lis-CHMP li ma kien hemm ebda konsegwenza għal pazjenti involuti fi provi kliniċi.
English: Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder.
Maltese: L-azzjoni ta' Aripiprazole tbiddel l-attività ta' dopamine u 5-hydroxytryptamine, li mhijiex normali fl-iskizofrenija u d-disturb bipolari.
English: Aripiprazole Mylan was developed as a ‘generic medicine'.
Maltese: Aripiprazole Mylan ġie żviluppat bħala ‘mediċina ġenerika'.
English: Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify.
Maltese: Minħabba li Aripiprazole Mylan huwa mediċina ġenerika, il-kumpanija kienet ippreżentat riżultati ta' studji f'voluntiera li juru li l-pillola tal-10 mg u l-pillola li tinħall fil-ħalq tal-10 mg Aripiprazole Mylan kienu bijoekwivalenti għall-pilloli tal-mediċina ta' referenza, Abilify.
English: This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Maltese: Dan ifisser li Aripiprazole Mylan huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Abilify.
English: To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine.
Maltese: Sabiex tappoġġja applikazzjoni għal ‘bijorinunzja', il-kumpanija ppreżentat ukoll testijiet mil-laboratorju sabiex turi li lqawwiet l-oħra tal-pilloli Aripiprazole Mylan jinħallu b'mod identiku għal mediċina ta' referenza.
English: Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder.
Maltese: Abbażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kien tal-fehma provviżorja li Aripiprazole Mylan ma setax jiġi approvat għall-kura tal-iskizofrenija u għall-kura u l-prevenzjoni ta' episodji manijakali f'pazjenti b'disturb bipolari I.
English: What was Aripiprazole Mylan expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Aripiprazole Mylan?
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters.
Maltese: Dan ifisser li aripiprazole jaġixxi bħal dopamine u 5-hydroxytryptamine billi jtattiva lil dawn ir-riċetturi, iżda għandu effett inqas b'saħħtu min-newtrotrasmettituri naturali.
English: agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Maltese: Aripiprazole hija maħsuba bħala ‘agonista parzjali' għar-riċetturi għan-newrotrażmettituri dopamine u 5-hydroxytryptamine (li
English: Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα
Maltese: 13o χλμ Ε.Ο. Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα
English: *MU : Million Units
Maltese: *MU: Miljun Unità
English: Overdose (symptoms, emergency procedures, antidotes)
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8° °C).
English: FI: Suomi/Finland
Maltese: Suomi/Finland
English: • in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon.
Maltese: • fil-qtates anemiċi, ir-rata tal-mortalità ta' madwar 60% f'4, 6, 9 u 12-il xahar tnaqqset b'madwar 30% wara l-kura b'interferon.
English: Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006
Maltese: Data tal-ewwel awtrizzazzjoni ;06.11.2001 / Data tal-aħħar tiġdid 21.11.2006
English: • in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon.
Maltese: • fil-qtates mhux anemiċi, ir-rata tal-mortalità ta' 50% fil-qtates infettati b'FeLV tnaqqset b'20% wara l-kura b'interferon.
English: Lyophilisate: white pellet Solvent: colourless liquid
Maltese: Lijofiliżat: pillola bajda Solvent: likwidu bla kulur
English: Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Maltese: Tliet trattamenti separati ta' 5 ijiem iridu jitwettqu f'jum 0, jum 14 u jum 60.
English: Szent Istvàn krt.11.II/21.
Maltese: VIRBAC Hungary KFT Szent Istvàn krt.11.II/21. 1055 Budapest Magyarország
English: Sodium hydroxide 0.2 M Sodium chloride D-Sorbitol
Maltese: Idrossidu tas-sodju 0.2M Kloridu tas-sodju
English: Store in the original carton.
Maltese: Aħżen fil-kartuna oriġinali.
English: Lyophilisate:
Maltese: ATCvet:
English: EE: Eesti
Maltese: Eesti
English: In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
Maltese: Fi qtates infettati minn FIV, il-mortalità kienet baxxa (5%) u ma kinetx influwenzata mill-kura.
English: The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV).
Maltese: jinvolvi it-titjib tad-difiża mhux speċifika tal-ġisem, b'mod partikulari fil-klieb kontra parvovirosi kanina u fil-qtates kontra retrovirosi felina (FeLV, FIV).
English: For the 10MU presentation:
Maltese: Preżentazzjoni ta' 10MU:
English: 5 MU presentation:
Maltese: Preżentazzjoni ta' 5MU:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati)
English: Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
Maltese: Omega interferon li joriġina mill-qtates, prodott minn inġinerija ġenetika, hu tip ta' Ι interferon li hu marbut mill-qrib ma' alpha interferon.
English: Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Maltese: Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents.
Maltese: OMEGA flimkien ma' antibijotiċi, soluzzjoni għall-idratazzjoni mill-ġdid, vitamini u mediċini ta' kontra l-infjammazzjoni non-sterojdjali.
English: For the full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1
English: Cardboard box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent Cardboard box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Maltese: Kaxxa tal-kartun b'2 kunjetti ta' lijofiliżat u 2 kunjetti ta' 1 ml ta' solvent Kaxxa tal-kartun b'5 kunjetti ta' lijofiliżat u 5 kunjetti ta' 1 ml ta' solvent
English: It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation).
Maltese: Ġeneralment, il mekkaniżmu tar-replikazzjoni jitwaqqaf kemm bil-qerda ta' mRNA u kemm mid-diżattivazzjoni talproteini tat-traduzzjoni (attivazzjoni 2'5' oligo-adenylate synthetase) fiċ-ċelluli infettati mill-vajrus.
English: NL: Nederland
Maltese: Nederland
English: Cats.
Maltese: Qtates.
English: Isotonic sodium chloride solution
Maltese: Soluzzjoni isotonika ta' kloridu tas-sodju
English: BG: Република България
Maltese: Република България
English: Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs (vomiting and soft faeces to mild diarrhoea, in cats only. )
Maltese: Sinjali kliniċi u temporanji bħal ipertermija (3-6 sigħat wara l-injezzjoni), letarġija u sinjali diġestivi
English: The dose is 2.5 MU/kg bodyweight.
Maltese: Id-doża hi ta' 2.5MU/kg ta' piż tal-ġisem.
English: Box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent.
Maltese: Kaxxa b'2 kunjetti ta' lijofiliżat u 2 kunjetti b'1ml ta' solvent.
English: VIRBAGEN OMEGA Solvent for suspension for injection
Maltese: Sustanza lijofilizzanti u solvent għal suspensjoni għall-injezzjoni
English: 10 DATE OF REVISION OF THE TEXT
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • slight sinus tachycardia.
Maltese: • żieda ħafifa tar-rata respiratorja • takikardija tas-sinus ħafifa.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Lyophilisate and solvent for suspension for injection.
Maltese: Sustanza lijofilizzanti u solvent għal suspensjoni għall-injezzjoni.
English: PACKAGE LEAFLET VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
Maltese: VETERINARJU VIRBAGEN OMEGA 5MU għal klieb u qtates VIRBAGEN OMEGA 10MU għal klieb u qtates
English: Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
Maltese: Interferon ma jaġixxix direttament u b'mod speċifiku fuq il-vajrus, iżda jeżerċita l-effett tiegħu bl-inibizzjoni tal-mekkaniżmi tas-sintesi interna taċ-ċelluli infettati.
English: Recombinant Omega interferon of feline origin 10 MU*/ ml * MU: Million Units
Maltese: Omega interferon rikombinanti li joriġina mill-qtates 10MU*/ml
English: 4.4 Special warnings for each target species
Maltese: 4.5 Prekawzjonijiet speċjali għall-użu
English: • mild lethargy and drowsiness
Maltese: ANNESS I KARATTERISTIĊI
English: Box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent.
Maltese: Kaxxa b'5 kunjetti ta' lijofiliżat u 5 kunjetti b'milliltru 1 ta' solvent.
English: Sodium chloride Water for injections
Maltese: Ilma għal injezzjonijiet
English: Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin.
Maltese: Kunjetti tal-ħġieġ ta' tip I magħluq b'tapp magħmul minn polimeru tal-lastku tal-butil miksi b'reżin tal-polimeru fluworokarbon
English: Recombinant Omega interferon of feline origin 5 MU*/ ml * MU: Million Units
Maltese: Omega interferon rikombinanti li joriġina mill-qtates 5MU*/ml
English: LT: Lietuva
Maltese: Lietuva
English: Solvent: Type I glass vial of 1 ml of solvent closed with butyl elastomer rubber stopper.
Maltese: Kunjetti tal-ħġieġ ta' tip I ta' 1 ml ta' solvent magħluq b'tapp tal-lastku tal-butil elastomer
English: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Maltese: Kura ta' qtates infettati b'FeLV u/jew FIV, fi stadji kliniċi mhux terminali, mill-età ta' 9 ġimgħat.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a suspension containing 5 MU of recombinant interferon.
Maltese: Il-porzjon freeze-dried irid ikun rikostitwit b'1ml tad-dilwent speċifiku biex tinkiseb suspensjoni li fiha 5MU ta' interferon rikombinanti.
English: Cats:
Maltese: CY:
English: Do not use after the expiry date stated on the label.
Maltese: Tużax wara d-data ta' skadenza li tidher fuq it-tikketta.
English: In the case of intravenous administration in cats, increased adverse reactions may be seen, e.g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
Maltese: Fil-każ ta' għoti ġol-vina fil-qtates, tista' sseħħ żieda ta' reazzjonijiet avversi, eż. ipertermija, ippurgar artab, anoreksja, nuqqas fix-xorb jew kollass.
English: Pharmacotherapeutic group: Interferons ATCvet code : QL03AB
Maltese: Klieb u qtates: intwera li konformità stretta mal-pożoloġija rakkomandata hi mandatorja biex jintlaħaq il-benefiċċju kliniku.
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains:
Maltese: Kull doża ta' 1 ml fih: Sustanza attiva:
English: PL: Polska
Maltese: Polska
English: VIRBAGEN OMEGA 10 MU for dogs and cats
Maltese: VETERINARJU VIRBAGEN OMEGA 10MU għal klieb u qtates
English: The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.
Maltese: Il-porzjon freeze-dried irid ikun rikostitwit b'1ml tad-dilwent speċifiku biex tinkiseb suspensjoni li fiha 10MU ta' interferon rikombinanti.
English: VIRBAC Hungary KFT
Maltese: TAGĦRIF
English: VIRBAGEN OMEGA 5 MU for dogs and cats
Maltese: VETERINARJU VIRBAGEN OMEGA 5MU għal klieb u qtates
English: However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.
Maltese: Madankollu, minħabba li tagħrif speċifiku dwar interazzjonijiet possibbli ta' interferon ma' prodotti oħrajn hu nieqes, kuri ta' sapport supplimentari għandhom jintużaw bl-attenzjoni u wara analiżi bir-reqqa tar-riskju/benefiċċju.
English: For the 5MU presentation: Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Maltese: Kaxxa tal-kartun b'5 kunjetti ta' lijofiliżat u 5 kunjetti ta' 1 ml ta' solvent
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Maltese: Tħallatx ma' ebda prodott ieħor ta' prodott mediċinali veterinarju, ħlief mas-solvent provdut mal-użu ta' dan il-prodott.
English: Recombinant Omega interferon of feline origin 10 MU* *MU : Million Units
Maltese: Omega interferon rikombinanti li joriġina mill-qtates 10MU*
English: VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
Maltese: FULJETT TA' TAGĦRIF VIRBAGEN OMEGA 5MU għal klieb u qtates VIRBAGEN OMEGA 10MU għal klieb u qtates
English: Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.
Maltese: Tnaqqis fil-mortalità u sinjali kliniċi ta' parvovirosi (forma enerika) fil-klieb sa mill-età ta' xahar.
English: Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.
Maltese: L-effikaċja tal-prodott fuq il-qtates b'forma tumuruża tal-infezzjoni minn FeLV, jew qtates infettati minn FeLV jew ko-infettati minn FIV fi stadji terminali ma kinetx ittestjata.
English: Cardboard box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent Not all pack sizes may be marketed.
Maltese: Kaxxa tal-kartun b'5 kunjetti ta' lijofiliżat u 5 kunjetti ta' 1 ml ta' solvent Għall-preżentazzjoni ta' 10MU:
English: Excipients:
Maltese: Qtates:
English: PACKAGE SIZE
Maltese: U KWANTITATTIVA
English: CZ: Česká republika
Maltese: Česká republika
English: Cats: In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA The use of supplementary supportive treatments improves prognosis.
Maltese: Fil-każ ta' kura ripetuta ta' mard kroniku marbut ma' epatite, ħsara fil-qalb u fil-kliewi, il-marda korrispondenti għandha tkun immonitorjata qabel l-għoti ta' VIRBAGEN OMEGA.
English: SI: Slovenija
Maltese: Slovenija
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Maltese: Skont Artiklu 71 ta' Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill kif emendat, l-Istati
English: This summary was last updated in 08-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2016.
English: The full EPAR for IDflu can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal IDflu jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: IDflu is a vaccine.
Maltese: IDflu huwa vaċċin.
English: This is a summary of the European public assessment report (EPAR) for IDflu.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal IDflu.
English: influenza vaccine (split virion, inactivated)
Maltese: Vaċċin tal-influwenza (virjon maqsum, inattivat)
English: IDflu contains fragments from three different strains of flu virus.
Maltese: IDflu fih frammenti minn tliet razez differenti tal-virus talinfluwenza.
English: Why has IDflu been approved?
Maltese: Għaliex ġie approvat IDflu?
English: IDflu contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
Maltese: IDflu fih 15-il mikrogramma ta' kull waħda mit-tliet razez differenti (varjetajiet) tal-virus tal-influwenza (sottotip H1N1, A/California/7/2009, NYMC
English: The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Maltese: L-effetti sekondarji l-aktar komuni b'IDflu (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, uġigħ fil-muskoli u reazzjonijiet fis-sit tal-injezzjoni (ħmura, nefħa, twebbis tal-ġilda, uġigħ u ħakk).
English: Three studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Maltese: Tliet studji taw ħarsa lejn persuni ta' 60 sena u aktar, li tlaqqmu bil-qawwa ta' 15-il mikrogramma.
English: IDflu must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
Maltese: IDflu m'għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal kwalunkwe wieħed mill-ingredjenti l-oħra, jew għal kwalunkwe komponent li jista' jinsab f'ammonti żgħar ħafna bħal bajd (l-ovalbumina, proteini tat-tiġieġ), neomiċina, formaldeid jew ottossinol 9.
English: In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
Maltese: Fil-persuni ta' 60 sena u aktar, ilqawwa ta' 15-il mikrogramma pprovdiet livell tajjeb ta' protezzjoni daqs il-vaċċini komparaturi.
English: Later seasonal formulations of IDflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Maltese: Il-formulazzjonijiet staġjonali ta' IDflu li ġew wara wrew li pproduċew risponsi simili ta' antikorpi kontra t-tliet razez tal-influwenza inklużi fil-vaċċin għal dawk osservati fl-istudji ewlenin.
English: IDflu is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Maltese: IDflu jintuża fit-tilqim tal-adulti li għandhom 60 sena u aktar kontra l-influwenza, speċjalment dawk li jkunu f'riskju ikbar li jiżviluppaw komplikazzjonijiet mill-marda.
English: When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-frammenti tal-virus bħala ‘barranin' u tipproduċi antikorpi kontrihom.
English: In the five original studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Maltese: Fil-ħames studji oriġinali, kemm IDflu kif ukoll il-vaċċin komparatur kisbu livelli xierqa ta' antikorpi għall-protezzjoni kontra t-tliet razez kollha ta' virus tal-influwenza.
English: IDflu is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Maltese: IDflu jingħata bħala injezzjoni ‘intradermali' waħda fis-saff ta' fuq tal-ġilda, bl-użu ta' sistema speċjali ta' mikroinjezzjoni.
English: The European Commission granted a marketing authorisation valid throughout the EU for IDflu on 24
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal IDflu valida fl-UE kollha fl-24 ta'
English: The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in
Maltese: L-immunoġeniċità u s-sigurtà ta' formulazzjonijiet sussegwenti tal-vaċċin ġew ukoll eżaminati fi studji.
English: How does IDflu work?
Maltese: IDflu?
English: The CHMP decided that IDflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' IDflu huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about IDflu
Maltese: Kif jaħdem
English: The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before
Maltese: L-istudji qabblu lkapaċità tal-vaċċini li jistimulaw il-produzzjoni ta' antikorpi (immunoġeniċità) billi qabblu l-livelli talantikorpi qabel l-injezzjoni u tliet ġimgħat wara.
English: The ability of IDflu to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Maltese: Il-kapaċità ta' IDflu li jistimula l-produzzjoni tal-antikorpi (immunoġeniċità) ġiet ivvalutata l-ewwel f'ħames studji ewlenin li fihom ħadu sehem kważi 9,000 persuna.