FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material with information about the safety of Esmya, including recommendations for monitoring liver function and endometrial changes during treatment.
Maltese: Il-kumpanija li tqiegħed Esmya fis-suq ser tiżgura li t-tobba li huma mistennija jippreskrivu din ilmediċina jirċievu materjal edukattiv b'informazzjoni dwar is-sigurtà ta' Esmya, inklużi rakkomandazzjonijiet għall-monitoraġġ tal-funzjoni tal-fwied u tat-tibdil fl-endometriju li jseħħ waqt ilkura.
English: What are the risks associated with Esmya?
Maltese: Kif jaħdem Esmya?
English: In the first study, uterine bleeding was reduced in 92% of women taking Esmya for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment).
Maltese: Fl-ewwel studju, il-fsada mill-utru tnaqqset fi 92 % tan-nisa li kienu qed jieħdu Esmya għal tliet xhur (kors ta' kura wieħed) meta mqabbel ma' 19 % tan-nisa li kienu qed jieħdu plaċebo (kura finta).
English: Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems.
Maltese: Ser tingħata wkoll karta lill-pazjenti biex tinfurmahom dwar il-ħtieġa għall-monitoraġġ tal-fwied u biex jikkuntattjaw lit-tabib tagħhom jekk jiżviluppaw sintomi ta' korriment fil-fwied (bħal għeja, sfura tal-ġilda, urina skura, nawsja u rimettar).
English: • as intermittent treatment for women in whom surgery is not suitable.
Maltese: • bħala kura intermittenti għal nisa li għalihom kirurġija mhijiex xierqa.
English: 1 See outcome of safety review carried out in 2018 here.
Maltese: Ara r-riżultat tar-reviżjoni tas-sigurtà li saret fl-2018 hawn
English: Esmya has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses).
Maltese: Esmya ntwera li huwa effettiv biex inaqqas is-sintomi kif ukoll iddaqs tal-fibrojdi f'nisa li kellha ssirilhom kirurġija għall-fibrojdi tagħhom u meta jintuża b'mod intermittenti għal perjodi itwal (sa 4 korsijiet ta' kura).
English: How does Esmya work?
Maltese: Kif jintuża Esmya?
English: For the full list of all side effects reported with Esmya, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Esmya, ara l-fuljett ta' tagħrif.
English: MA (EU) Number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size blister (PVC/alu)
Maltese: Daqs tal-pakkett folja (PVC/alu)
English: They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
Maltese: Kienu awtorizzati permezz ta' proċeduri nazzjonali approvati taħt diversi ismijiet kummerċjali (Bioparox, Fusaloyos, Locabiotal u Locabiosol) fl-pajjiżi li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, irRepubblika Ċeka, l-Estonja, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Portugall, ir-Rumanija, is-Slovakkja, u Spanja.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Fusafungine-containing medicines have been available in several EU countries for over 50 years.
Maltese: Mediċini li fihom fusafungine ilhom disponibbli f'diversi pajjiżi tal-UE għal aktar minn 50 sena.
English: The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' mediċini li fihom fusafungine inbdiet fil-11 ta' Settembru 2015 fuq talba tal-Italja, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: 1 April 2016 EMA/227560/2016
Maltese: 1 ta' April 2016
English: Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Maltese: Fusafungine huwa mediċina antibijotika u anti-infjammatorja użat fil-forma ta' sprej nażali u għallmembrana mukuża tal-ħalq (li għandu jintuża fil-ħalq) għall-kura tal-infezzjonijiet tal-passaġġi tal-arja ta' fuq li ġejjin: sinużite (infezzjoni tas-sinus), rinite (imnieħer imblukkat jew iqattar), rinofarinġite (riħ komuni), tonsillite (infjammazzjoni tat-tunsilli ikkawżata minn infezzjoni) u larinġite (infjammazzjoni tal-kaxxa vokali).
English: As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 31 March 2016.
Maltese: Peress li mediċini li fihom fusafungine huma kollha awtorizzati fuq livell nazzjonali, irrakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adotta pożizzjoni finali fil-31 ta' Marzu 2016.
English: Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
Maltese: Mediċini li għandhom jiġu rtirati minħabba reazzjonijiet allerġiċi serji u evidenza limitata ta' benefiċċju
English: The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp regolatorju li jirrappreżenta lill-Istati Membri tal-UE kif ukoll lill-Iżlanda, lilLiechtenstein u lin-Norveġja.
English: During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.
Maltese: Waqt ir-reviżjoni tiegħu, il-PRAC ikkonsulta lillkumitat pedjatriku xjentifiku tal-EMA kif ukoll lil esperti fil-qasam tal-mediċini kontra l-infezzjoni.
English: • These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
Maltese: • Dawn l-isprejs qegħdin jitneħħew mis-suq fl-UE minħabba każijiet rari ta' reazzjonijiet allerġiċi serji u n-nuqqas ta' evidenza b'saħħitha li dawn il-mediċini jaħdmu.
English: Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Maltese: Fusafungine huwa sprej antibijotiku u anti-infjammatorju tal-imnieħer u l-ħalq użat sabiex jikkura infezzjonijiet tal-passaġġi tal-arja ta' fuq bħal rinofariniġite (riħ komuni).
English: • Patients with any questions should speak to their healthcare professional.
Maltese: • Pazjenti li għandhom xi mistoqsijiet għandhom ikellmu lill-professjonista tal-kura tas-saħħa tagħhom.
English: With regard to the benefits, the evidence for beneficial effects of fusafungine is weak.
Maltese: Fir-rigward tal-benefiċċji, l-evidenza tal-effetti benefiċjarji ta' fusafungine hija dgħajfa.
English: The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU.
Maltese: Is-CMDh1 approva b'kunsens ir-revoka tal-awtorizzazzjoni għat-tqegħid fis-suq għall-isprejs ta' fusafungine fl-UE.
English: This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.
Maltese: Dan isegwi rieżami mill-Kumitat għall-Evalwazzjoni tar-Riskju fil-qasam talFarmakoviġilanza (PRAC) tal-EMA li kkonkluda li l-benefiċċji ta' fusafungine mhumiex akbar mir-riskji tiegħu, b'mod partikolari r-riskju ta' reazzjonijiet allerġiċi serji.
English: Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out.
Maltese: Għalkemm m'hemmx biżżejjed evidenza sabiex jiġi stabbilit li fusafungine jista' jżid ir-riskju ta' reżistenza, ir-riskju ma setax jiġi eskluż.
English: • Orthostatic hypotension
Maltese: • Ipotensjoni Ortostatiku
English: • Prophylaxis of migraine headache
Maltese: • Profilassi tal-uġiegħ ta' ras minn emigranja
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Maltese: Kull referenza għall-indikazzjonijiet imsemmija hawn fuq għandhom jiġu maqtugħa mill-kumpliment tas-sezzjonijiet relevanti tas-sommarji tal-karatteristiċi tal-prodott.
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Maltese: Kull referenza għall-indikazzjonijiet imsemmija hawn fuq għandhom jiġu maqtugħa mis-sezzjonijiet relevanti tal-fuljetti ta' tagħrif.
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Maltese: Anness III Emendi fis-sezzjonijiet rilevanti tas-sommarji tal-karatteristiċi tal-prodott u il-fuljetti ta' tagħrif
English: B. Package Leaflet
Maltese: TAL-PRODOTT
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Maltese: 4.1 Indikazzjonijiet Terapewtiċi [l-indikazzjonijiet approvati bħalissa hawn taħt għandhom jiġu maqtugħa (il-kliem speċifiku talindikazzjoni jista' jvarja bejn prodott u ieħor)]
English: 1 bottle + 2 syringes of 1 ml + 2 syringes of 5 ml + 2 bottle adaptors
Maltese: 1 flixkun + 2 siringi ta' 1 mL + 2 siringi ta' 5 mL + 2 adapters tal-flixkien
English: EU/1/19/1389/001 Epidyolex 100 mg/mL Oral Solution
Maltese: EU/1/19/1389/001 Epidyolex
English: Oral use bottle (glass)
Maltese: Kontenut (konċentrazzjoni)
English: 100 ml
Maltese: 100 mg/mL Soluzzjoni orali
English: Ref. EMEA/CHMP/541853/2008
Maltese: EMEA/CHMP/541630/2008
English: London, 6 October 2008 Doc.
Maltese: Londra, 6 ta' Ottubru 2008 Dok. Ref.
English: Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ml oral drops, 1 mg/ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Maltese: Zyrtec u ismijiet assoċjati, pilloli ta' 10mg miksija b'rita, 10mg/ml taqtir orali, 1mg/ml soluzzjoni orali, huwa mediċina għal kontra l-allerġiji indikat sabiex itaffi s-sintomi nażali u okulari ta' rinite allerġika staġjonali jew perenni u dawk tal-urtikarja idjopatika kronika.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif supplimentari fit-28 ta' Jannar 2008.
English: This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Maltese: Il-prodott mediċinali jagħmel parti mil-lista ta' prodotti tal-2007 li huma identifikati għallarmonizzazzjoni tal-SPC.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names International Non-Proprietary Name (INN): cetirizine
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): cetirizine
English: On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Maltese: Fid-9 ta' Ottubru 2007 il-Kummissjoni ppreżentat referenza lill-EMEA skont l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC) u t-Tikketta u l-Fuljett ta' Tagħrif (it-tnejn huma awtorizzati fuq livell nazzjonali) għall-prodott mediċinali Zyrtec u ismijiet assoċjati.
English: The procedure started on 18 October 2007.
Maltese: Il-proċedura bdiet fit-18 ta' Ottubru 2007.
English: During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Mejju 2008, is-CHMP, fid-dawl tat-tagħrif globali sottomess u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni ta' l-SPC, itTikketta u l-Fuljett ta' Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
English: The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
Maltese: Fit-30 ta' Mejju 2008, is-CHMP ta opinjoni pożittiva fejn irrakkomanda l-armonizzazzjoni tal-SPC, itTikketta u l-Fuljett ta' Tagħrif għal Zyrtec u ismijiet assoċjati.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Maltese: Il-bażi għar-referenza kienet li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Zyrtec u l-ismijiet assoċjati approvati fi ħdan l-Istati Membri ta' l-Unjoni Ewropea, b'mod partikolari fir-rigward tal-indikazzjonijiet, il-pożoloġija, il-kontraindikazzjonijiet u t-twissijiet speċjali.
English: 04011 Campoverde di Aprilia (LT) Italy
Maltese: 04011 Campoverde di Aprilia (LT) Italja
English: Let stand for 20 minutes.
Maltese: Ħalliha toqgħod għal 20 minuta.
English: In vitro studies of antiviral activity
Maltese: Studji in vitro tal-attività antivirali
English: AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA
Maltese: MedImmune Court / 633 Research Court, Frederick, Maryland, USA
English: These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Maltese: Dawn id-dożi kienu ta' 20.25 mg/kg, 21.1 mg/kg u 22.27 mg/kg.
English: Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Maltese: Data ta' l-ewwel awtorizzazzjoni: 13 ta' Awissu 1999 Data ta' l-aħħar tiġdid: 27 ta' Lulju 2009
English: - The active substance is palivizumab.
Maltese: - Is-sustanza attiva hi palivizumab.
English: (3 x 0.15) ml = 0.45 ml palivizumab per month
Maltese: (3 x 0.15) ml = 0.45ml palivizumab kull xahar
English: Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
Maltese: Minn dan il-grupp 1,250 tifel u tifla ħadu 6 injezzjonijiet, 183 tifel u tifla ħadu 7 injezzjonijiet u 27 tifel u tifla ħadu 8 jew 9 injezzjonijiet.
English: Store in a refrigerator (2ºC to 8ºC).
Maltese: Aħżen fil-friġġ (2C - 8C).
English: The injection should be given using standard aseptic technique.
Maltese: L-injezzjoni għandha tingħata bil-metodu aseptiku standard.
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: FEJN MA JIDHIRX U MA JINTLAĦAQX MIT-TFAL
English: In the second study, 211 and 202 premature infants or children with chronic lung disease received liquid and lyophilised palivizumab, respectively.
Maltese: Fit-tieni studju, 211 u 202 trabi prematuri jew tfal bil-marda kronika tal-pulmun rċevew palivizumab likwidu u lipofilizzat, rispettivament.
English: Lyophilised formulation of palivizumab
Maltese: Formulazzjoni lipofilizzata ta' palivizumab
English: However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Maltese: Madankollu, l-istabilita' waqt l-użu ġiet ippruvata għal 3 sigħat f'temperatura ta' 20 - 24oC.
English: Contents of the pack and other information
Maltese: Kontenuti tal-pakkett u informazzjoni
English: Solvent for Synagis
Maltese: Solvent għal Synagis
English: Pharmacotherapeutic group: immune sera immunoglobulins, specific immunoglobulins; ATC Code: J06BB16
Maltese: Kategorija farmakoterapewtika: sera immuni u immunoglobulini, immunoglobulini speċifiċi, Kodiċi ATC:
English: Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Maltese: Is-soluzzjoni ta' Palivizumab għanda toqgħod f'temperatura tal-kamra għal minimu ta' 20 minuta sakemm is-soluzzjoni tiċċara.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista taddati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany
Maltese: KG D-88397 Biberach an der Riss Ġermanja
English: The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Maltese: Il-każijiet ta' sptar b'RSV kienu jammontaw għal 9.7% fil-grupp tal-plaċebo u 5.3% fil-grupp ta' Synagis.
English: АбВи ЕООД Тел.
Maltese: Pakkett ta' wieħed.
English: After incubation for 4-5 days, RSV antigen was measured in an enzyme-linked immunosorbent assay (ELISA).
Maltese: Wara l-inkubazzjoni għal 4-5 ijiem, l-antiġen RSV kien imkejjel flassaġġ immunosorbenti enzimatiku (ELISA) .
English: Analysis of 254 clinical RSV isolates collected from immunoprophylaxis-naïve subjects revealed palivizumab resistance-associated substitutions in 2 (1 with N262D and 1 with S275F), resulting in a resistance associated mutation frequency of 0.79%.
Maltese: Analiżi ta' 254 iżolati kliniċi tal-RSC miġbura minn suġġetti li ma jafux li qed jieħdu l-immunoprofilassi wriet sostituzzjonijiet assoċjati marreżistenza ta' palivizumab fi 2 (1 mal-N262D u 1 mal-S275F), li rriżulta fi frekwenza ta' mutazzjoni assoċjata mar-reżistenza ta' 0.79 %.
English: For the full list of excipients, see section 6.1.
Maltese: Għal lista kompluta ta' ta' eċċipjenti, ara sezzjoni 6.1.
English: Also contains: histidine, glycine and mannitol.
Maltese: Fih ukoll: histidine, glycine u mannitol.
English: Synagis is not indicated for use in adults.
Maltese: Synagis mhuwiex indikat għall-użu minn persuni adulti.
English: Palivizumab exhibited median EC50 values of 0.65 g/ml (mean [standard deviation] = 0.75 [0.53] g/ml; n=69, range 0.07-2.89 g/ml) and 0.28 g/ml (mean [standard deviation] = 0.35 [0.23] g/ml; n=35, range 0.03-0.88 g/ml) against clinical RSV A and RSV B isolates, respectively.
Maltese: 07-2.89 g/ml ) u 0.28 g / ml (medja [ standard devjazzjoni ] = 0.35 [ 0.23 ] g/ml; n = 35 , medda ta' 0.
English: Single dose toxicology studies have been conducted in cynomolgus monkeys (maximum dose 30 mg/kg), rabbits (maximum dose 50 mg/kg) and rats (maximum dose 840 mg/kg).
Maltese: Studji tossikologiċi dwar meta tittieħed doża waħda ġew magħmula fuq xadini ċinomologi (doża massima ta' 30 mg/kg), fniek (doża massima ta' 50 mg/kg) u firien (doża massima ta' 840mg/kg).
English: Synagis is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Maltese: Synagis huwa ppreżentat bħala trab u solvent għal soluzzjoni għall-injezzjoni (50mg ta' trab f' kunjett) + 1 ml ta' solvent f' ampulla - Pakkett ta' 1.
English: °C)
Maltese: NUMRU(I)
English: Swirl gently.
Maltese: Aħżen fi friġġ.
English: This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Maltese: Dan l-anti-korp uman monoklonali huwa magħmul minn sekwenzi ta' anti-korpi umani (95%) u tal-ġrieden (5%).
English: Palivizumab is a humanised IgG1 monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV).
Maltese: IgG1 monoklonali intenzjonat għall-epitope fis-sit A antiġeniku tal-proteina ta' fużjoni tal-virus sinktjali (RSV).
English: *Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
Maltese: *Palivizumab huwa anti-korp uman monoklonali rikombinat u prodott b'teknoloġija ta' DNA f'celloli ta' myeloma f'ġurdien.
English: CHD Study 2: this trial, conducted at 162 centers in North America, European Union and 4 other countries over two RSV seasons, studied patients less than or equal to 24 months of age with hemodynamically significant CHD.
Maltese: CHD Studju 2: din il-prova, li saret f'162 ċentri fl-Amerika ta' Fuq, fl-Unjoni Ewropeja u 4 pajjiżi oħra waqt żewġ staġuni ta' RSV, studjat pazjenti li għandhom 24 xahar jew anqas b'CHD emodinamikament sinifikanti.
English: Solution for injection 100 mg/1 ml
Maltese: Soluzzjoni għall-injezzjoni 100 mg/1 ml
English: 1 ml Water for injections
Maltese: 1 ml ilma għall-injezzjonijiet
English: Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection Active substance: palivizumab
Maltese: Synagis 50 mg/0.5 ml soluzzjoni għall-injezzjoni Synagis 100 mg/1 ml soluzzjoni għall-injezzjoni Sustanza attiva: palivizumab
English: The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells.
Maltese: Il- titru ta' newtralizzazzjoni (konċentrazzjoni effettiva ta' 50% [ EC50 ] ) kien muri bħala l-konċentrazzjoni meħtieġa tal-antikorp sabiex innaqqas l-ammont tal-antiġen RSV b'50% meta mqabbel maċ-ċelloli infettati bil-virus mhux trattati.
English: At least one of the palivizumab resistance-associated substitutions, N262D, K272E/Q, or S275F/L was identified in these 8 clinical RSV isolates resulting in a combined resistance-associated mutation frequency of 6.3% in these patients.
Maltese: Mill-inqas wieħed mis-sostituzzjonijiet assoċjati mar-reżistenza ta' palivizumab, N262D, K272E/Q, jew S275F/L ġie identifikat f'dawn it-8 iżolati kliniċi tal-RSV li rriżulta fi frekwenza ta' mutazzjoni kkombinata assoċjata mar-reżistenza ta' 6.3% f'dawn il-pazjenti.
English: Solution for injection 50 mg/0.5 ml
Maltese: Soluzzjoni għall-injezzjoni 50 mg/0.5 ml
English: In prophylactic studies in premature and bronchopulmonary dysplasia paediatric populations, the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 40 g/ml after the first injection, approximately 60 g/ml after the second injection, approximately 70 g/ml after the third injection and fourth injection.
Maltese: Fi studji profilattiċi f'pazjenti pedjatriċi prematuri u f'pazjenti pedjatriċi li jbatu minn displażja bronkopulmonari, il-half-life medja ta' palivizumab kienet 20 ġurnata u dożi intramuskolari ta' 15 mg/kg mogħtija kull xahar pproduċew medja ta' konċentrazzjoni minimali tas-sustanza attiva fisserum fi 30 gurnata, ta' bejn wieħed u ieħor 40 g/ml wara l-ewwel injezzjoni, bejn wieħed u ieħor 60 g/ml wara t-tieni injezzjoni, u bejn wieħed u ieħor 70 g/ml wara it-tielet u r-raba` injezzjoni.
English: Synagis 50 mg vial label
Maltese: Synagis 50 mg Tikketta tal-Kunjett