FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of IL-17-producing cells was also significantly higher in the subchondral bone marrow of facet joints from patients with ankylosing spondylitis.
Maltese: Il-frekwenza taċċelluli li jipproduċu IL-17 kienet ukoll ogħla b'mod sinjifikanti fil-mudullun subkondrali ta' ġogi talispina minn pazjenti bi spondilite ankilotika.
English: Secukinumab has the potential to increase the risk of infections.
Maltese: Secukinumab għandu l-potenzjal li jżid ir-riskju ta' infezzjonijiet.
English: • Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Maltese: • Armi l-pinna użata f'kontenitur li fih jintremgħu oġġetti bil-ponta jew li jaqtgħu (jiġifieri kontenitur magħluq li ma jittaqqabx, jew simili).
English: The percentage of patients with no disease progression from week 24 to week 52 for secukinumab 10 mg/kg intravenous load - followed by 150 mg subcutaneous maintenance and for placebo patients who switched to 75 mg or 150 mg subcutaneous every 4 weeks at week 16 or week 24 was 85.7% and 86.8%, respectively.
Maltese: Ilperċentwal ta' pazjenti mingħajr progressjoni tal-marda mill-24 ġimgħa sat-52 ġimgħa għall-għoti ta' doża għolja tal-bidu ta' secukinumab 10 mg/kg fil-vini - segwit minn manteniment ta' 150 mg taħt ilġilda u għall-pazjenti fuq plaċebo li qalbu għal 75 mg jew 150 mg taħt il-ġilda kull 4 ġimgħat f'ġimgħa 16 jew ġimgħa 24 kien ta' 85.
English: IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis and ankylosing spondylitis and is up-regulated in lesional skin in contrast to non-lesional skin of plaque psoriasis patients and in synovial tissue of psoriatic arthritis patients.
Maltese: IL-17A għandu sehem ewlieni fil-patoġenesi tal-psorjasi tal-plakka, artrite psorjatika u spondilite ankilotika u hu sopraregolat f'ġilda b'leżjonijiet b'kuntrast ma' ġilda mingħajr leżjonijiet f'pazjenti bi psorjasi tal-plakka u f'tessut sinovjali ta' pazjenti b'artrite psorjatika.
English: All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all endpoints at week 16.
Maltese: Il-valuri p kollha huma aġġustati għall-multipliċità tal-ittestjar abbażi ta' ġerarkija definita minn qabel fl-24 ġimgħa għall-istudju 2 tal-PsA, għajr għal ACR70, Dattilite u Entesite, li kienu endpoints esploratorji u l-endpoints kollha fis-16-il ġimgħa.
English: Elderly patients (aged 65 years and over) No dose adjustment is required (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża (ara sezzjoni 5.2).
English: Multipack: 6 (3 packs of 2) pre-filled syringes
Maltese: Soluzzjoni għall-injezzjoni Pakkett multiplu: 6 (3 pakketti ta' 2 siringi) mimlija għal-lest
English: Patients treated with secukinumab 150 mg showed improvements in spinal mobility as measured by change from baseline in BASMI at week 16 for both AS study 1 (-0.40 versus -0.12 for placebo; p=0.0114) and AS study 2 (-0.51 versus -0.22 for placebo; p=0.0533).
Maltese: Pazjenti kkurati b'secukinumab 150 mg urew titjib fil-mobilità tal-ispina kif imkejla mill-bidla millinja bażi f'BASMI f'ġimgħa 16 kemm għal studju 1 tal-AS (-0.40 kontra -0.
English: The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber.
Maltese: Is-siringa mimlija għal-lest fil-pinna hija siringa tal-ħġieġ b'tapp tal-planġer tal-lastiku bromobutyl miksi bis-silicone, b'labra mwaħħla miegħu ta' 27G x ½″ u b'tokka riġida tal-labra magħmula minn lastku styrene butadiene.
English: Patients randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Maltese: Il-pazjenti randomizzati għal secukinumab ingħataw 75 mg, 150 mg jew 300 mg taħt il-ġilda fil ġimgħat 0, 1, 2, 3 u 4, segwita bl-istess doża kull xahar.
English: 2 pre-filled pens.
Maltese: Tagħmilhiex fil-friża.
English: Carefully withdraw slightly more than 1.0 ml of the solution for subcutaneous injection from the vial into a 1 ml graduated disposable syringe using a suitable needle (e.g. 21G x 2″).
Maltese: B'attenzjoni iġbed ħarira aktar minn 1.0 ml tas-soluzzjoni għall-injezzjonijiet taħt il-ġilda mill-kunjett f'siringa ta' 1 ml li tintuża darba biss u bi gradwazzjoni billi tuża labra xierqa (eż. 21G x 2″).
English: Cosentyx is used to treat a condition called “psoriatic arthritis”.
Maltese: Cosentyx jintuża biex jikkura kondizzjoni msejħa “artrite psorjatika”.
English: Psoriasis study 4 (JUNCTURE) evaluated 182 patients using a pre-filled pen compared with placebo after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab self-administration via the pre-filled pen.
Maltese: Studju 4 dwar Psorjasi (JUNCTURE) evalwa 182 pazjent mogħtija pinen mimlija għal-lest imqabbla mal-plaċebo wara 12-il ġimgħa ta' trattament biex jistma s-sigurtà, it-tollerabbiltà, u l-użabbiltà tal-pinna mimlija għal-lest secukinumab u li tingħata mill-pazjent innifsu.
English: Based on clinical response, the dose can be increased to 300 mg.
Maltese: Abbażi tar-rispons kliniku, id-doża tista' tiżdied għal 300 mg.
English: * Patients treated with secukinumab received 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every 4 weeks until week 52.
Maltese: * Pazjenti ttrattati b'secukinumab ngħataw dożi ta' 300 mg fil-ġimgħat 0, 1, 2, 3 u 4, wara komplew bl-istess doża kull 4 ġimgħat sat-52 ġimgħa.
English: The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections (most frequently nasopharyngitis, rhinitis).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) irrappurtati spiss huma infezzjonijiet fin-naħa ta' fuq tal-passaġġ respiratorju (l-aktar frekwenti nażofarinġite, rinite).
English: Secukinumab 150 mg and 300 mg treatment significantly inhibited the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS at week 24 (Table 6).
Maltese: Trattament b'secukinumab 150 mg u 300 mg inibixxa b'mod qawwi r-rata ta' progressjoni tal-ħsara tal-ġogi periferali mqabbel mat-trattament bil-plaċebo kif imkejjel skont il-bidla mil-linja bażi mill-mTSS fl-24 ġimgħa (Tabella 6).
English: For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Maltese: Għall-pazjenti bi psorjasi tal-plakka konkomitanti minn moderata sa gravi jew li wieġbu b'mod inadegwat (IR) għal terapija anti-TNFα, id-doża rakkomandata hija 300 mg permezz ta' injezzjoni taħt il-ġilda b'doża inizjali fil-ġimgħat 0, 1, 2, 3 u 4, segwita b'dożaġġ ta' manutenzjoni kull xahar.
English: The 300 mg dose provided improved skin clearance particularly for “clear” or “almost clear” skin across the efficacy endpoints of PASI 90, PASI 100, and IGA mod 2011 0 or 1 response across all studies with peak effects seen at week 16, therefore this dose is recommended.
Maltese: Id-doża ta' 300 mg tejbet il-fejqan tal-ġilda b'mod partikulari fejn tidħol ġilda “ċara” jew “kważi ċara” b'rabta mal-punti finali tal-effikaċja ta' PASI 90, PASI 100, u IGA mod 2011 b'reazzjoni ta' 0 jew 1 fuq il-firxa tal-istudji kollha bl-ogħla effetti jidhru f'ġimgħa 16, u għaldaqstant din id-doża hi rrakkommandata.
English: • The green indicator shows the progress of the injection.
Maltese: • L-indikatur l-aħdar juri l-progress tal-injezzjoni.
English: IgGs are mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance of secukinumab.
Maltese: Waqt studji kliniċi, ma kinitx irrappurtata żieda fis-suxxettibilità għat-tuberkulożi.
English: PEN LABEL
Maltese: Labra Sistema protettiva
English: Nevertheless, the use of Cosentyx pre-filled syringes in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out.
Maltese: Madankollu, ma sarux studji dwar l-użu ta' siringi mimlija għal-lest Cosentyx f'individwi sensittivi għal-latex u għalhekk hemm riskju potenzjali ta' reazzjonijiet ta' sensittività eċċessiva li ma jistax jiġi eskluż kompletament.
English: Nevertheless, the use of Cosentyx pre-filled pens in latex-sensitive individuals has not been studied and there is therefore a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Maltese: Madankollu, ma sarux studji dwar l-użu ta' pinen mimlija għal-lest Cosentyx f'individwi sensittivi għal-latex u għalhekk hemm riskju potenzjali ta' reazzjonijiet ta' sensittività eċċessiva li ma jistax jiġi eskluż kompletament.
English: Table 5 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24
Maltese: Rispons kliniku fl-istudju 2 tal-PsA u fl-istudju 3 tal-PsA fis-16-il ġimgħa u l24 ġimgħa studju 2 tal-PsA
English: Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis (PsA) at baseline.
Maltese: III kellhom artrite psorjatika (PsA - psoriatic arthritis) fil-linja bażi.
English: Patients in Ankylosing Spondylitis study 1 (AS study 1) and Ankylosing Spondylitis study 2 (AS study 2) had a diagnosis of AS for a median of 2.7 to 5.8 years.
Maltese: Il-pazjenti fi studju 1 dwar l-Ispondilite Ankilotika (studju 1 tal-AS) u fi studju 2 dwar l-Ispondilite Ankilotika (studju 2 tal-AS) saritilhom dijanjożi tal-AS għal perjodu medju ta' bejn 2.7 snin sa 5.8 snin.
English: Each pre-filled pen contains 150 mg secukinumab.
Maltese: Kunjett wieħed fih 150 mg secukinumab.
English: Similar responses were seen in PsA study 1.
Maltese: Ġew osservati reazzjonijiet simili flistudju 1 tal-PsA.
English: Statistically significant improvements at week 12 (studies 1-4) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Maltese: Riżultati rrappurtati dwar ir-rabta bejn il-kwalità tal-ħajja u l-pazjent Kien hemm titjib statistikament sinifikanti f'ġimgħa 12 (studji 1-4) mil-linja bażi mqabbel mal-plaċebo skont id-DLQI (Dermatology Life Quality Index).
English: Cosentyx is used in adults with moderate to severe plaque psoriasis.
Maltese: Cosentyx jintuża fl-adulti li għandhom psorjasi tal-plakka minn moderata sa qawwija.
English: Store your boxed pen in a refrigerator between 2°C and 8°C and out of the reach of children.
Maltese: Aħżen il-kaxxa bil-pinna fi friġġ f'temperatura bejn 2°C u 8°C u tħallihiex fejn jistgħu jilħquha t-tfal.
English: Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Maltese: Tużax is-siringa wara d-data ta' meta tiskadi li tidher fuq il-kaxxa ta' barra jew it-tikketta tas-siringa wara “JIS”/“EXP”.
English: Your Cosentyx SensoReady pen:
Maltese: Kif tarmi l-pinna Cosentyx SensoReady tiegħek:
English: Plunger head
Maltese: Ż-ŻGĦAR EWLENIN
English: System Organ Class Frequency Adverse reaction Infections and infestations
Maltese: Klassi tas-Sistemi u tal-Organi
English: Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni, wara doża waħda mogħtija taħt il-ġilda ta' 150 mg jew 300 mg lil pazjenti bi psorjasi tal-plakka, secukinumab laħaq l-ogħla konċentrazzjonijiet fis-serum ta' 13.7±4.8 µg/ml jew f'27.
English: If you have active psoriatic arthritis you will first be given other medicines.
Maltese: Jekk int għandek artrite psorjatika attiva, mela l-ewwel tingħata mediċini oħra.
English: Cosentyx is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label.
Maltese: Cosentyx huwa disponibbli f'siringa mimlija għal-lest u li tintuża darba biss immuntata f'pinna b'forma triangulari b'tieqa trasparenti u tikketta.
English: However, secukinumab should not be given to patients with active tuberculosis.
Maltese: Madanakollu, secukinumab m'għandux jingħata lil pazjenti b'tuberkulożi attiva.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq il-fertilità.
English: Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar.
Maltese: Il-biċċa l-kbira tal-kwalitajiet farmakokinetiċi osservati f'pazjenti bi psorjasi tal-plakka, artrite psorjatika u spondilite ankilotika kienu simili.
English: Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by week 3 for the 300 mg dose.
Maltese: Secukinumab kien assoċjat ma bidu mgħaġġel ta' effikaċja bi tnaqqis ta' 50% fil-medja ta' PASI mat-3 ġimgħa għad-doża ta' 300 mg.
English: Your Cosentyx pre-filled syringe
Maltese: Minn fejn taqbad is-siringa
English: Cosentyx is available in unit packs containing 1 or 2 pre-filled pen(s) and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Maltese: Cosentyx hu disponibbli f'pakketti ta' doża waħda li fihom pinna waħda jew tnejn mimlija għal-lest u f'pakketti multipli li fihom 6 (3 pakketti ta' 2) pinen mimlija għal-lest.
English: Viewing window, label & expiry date
Maltese: Tieqa biex tara, tikketta u d-data ta' meta tiskadi
English: In both study 1 and study 2, patients randomised to receive placebo who were non-responders at week 12 then crossed over to receive secukinumab (either 150 mg or 300 mg) at weeks 12, 13, 14, and 15, followed by the same dose every month starting at week 16.
Maltese: Kemm fi studju 1 u anke fi studju 2, il-pazjenti randomised biex jingħataw plaċebo li ma kinux irreaġixxew f'ġimgħa 12 wara għaddew biex jingħataw secukinumab (150 mg jew 300 mg) f'ġimgħat 12, 13, 14, u 15, segwiti bl-istess doża kull xahar b'bidu f'ġimgħa 16.
English: Pack containing 1 pre-filled syringe
Maltese: Studju 1 tal-PsA
English: Most of the following side effects are mild to moderate.
Maltese: Bosta mill-effetti sekondarji li ġejjin huma ħfief jew moderati.
English: 15 µg haemagglutinin per strain per 0.1 ml dose
Maltese: 15 µg emagglutinin kull strain kull doża ta' 0.1 ml
English: Micro-Injection System
Maltese: Sistema ta' Mikro-Injezzjoni
English: B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 N = 2,586
Maltese: B A/New Caledonia/20/99 A/Wisconsin/67/2005
English: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Maltese: Val-de-Reuil - Franza Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Franza
English: Intradermal 15µg A/H3N2
Maltese: A/H3N2
English: MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Maltese: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Franza.
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista kompleta ta' sustanzi mhux attivi ara sezzjoni 6.1.
English: EU/1/08/507/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/507/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/507/006 - pack of 20 pre-filled syringes with a Micro-Injection System
Maltese: EU/1/08/507/004 - pakkett ta' siringa mimlija għall-lest b'Sistema ta' Mikro-Injezzjoni EU/1/08/507/005 - pakkett ta' 10 siringi mimlija għall-lest b'Sistema ta' Mikro-Injezzjoni EU/1/08/507/006 - pakkett ta' 20 siringa mimlija għall-lest b'Sistema ta' Mikro-Injezzjoni
English: Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France
Maltese: Sanofi Pasteur Parc Industriel d'Incarville 27100
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION IDflu 15 µg/strain 2016/2017
Maltese: IDflu 15 µg/razza 2016/2017
English: EU/1/08/507/006
Maltese: EU/1/08/507/005 EU/1/08/507/006
English: Pack size of 1 or 10 or 20.
Maltese: Mikro-Injezzjoni f'pakketti ta' 1, 10 jew 20.
English: Finger pads
Maltese: Pads tas subgħajn
English: Precautions to be taken before handling or administering the medicinal product For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet għal preparazzjoni tal-prodott mediċinali qabel ma jingħata , ara sezzjoni 6.6.
English: The safety of IDflu has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of IDflu.
Maltese: Is-sigurtà ta' IDflu kienet evalwata f'3 studji kliniċi open-label u randomised li fihom 3,372 pazjent irċivew injezzjoni ta' IDflu.
English: Very limited data in immunocompromised patients are available for IDflu.
Maltese: Hemm dejta limitat ħafna fuq IDflu f'pazjenti li huma immunokompromissati.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DEJTA LI TINQARA MILL-BNIEDEM PC:
English: 1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System
Maltese: 1 siringa mimlija għall-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni 10 siringi mimlijin għall-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni 20 siringa mimlija għall-lest (0.1 ml) b'Sistema ta' Mikro-Injezzjoni
English: The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
Maltese: Id-dejta t'hawn taħt tagħti l-frekwenzi tar-reazzjonijiet avversi fil-qosor li kienu rrekordjati waqt t-tilqim minn studji kliniċi u esperjienza wara li tpoġġa fuq is-suq madwar id-dinja kollha bl-użu tal konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10000 sa <1/1000); rari ħafna (<1/10000), mhux magħruf (ma tistax tittieħed stima
English: The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Is-sustanzi l-oħra huma: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għal injezzjonijiet.
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Maltese: III, 398 individwu li kellhom iżjed minn 65 sena rċivew 0.1 ml ta' IDflu mir-rotta intradermali, u 397 individwu li kellhom iżjed minn 65 sena rċivew 0.5 ml ta' tilqima tal-influwenza trivalenti inattivata u adjuvanti (li fiha MF-59) fl-istess dożaġġ mogħti mirrotta intradermali.
English: Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Maltese: A/California/7/2009 (H1N1)pdm09 - bħal razza A/Hong Kong/4801/2014 (H3N2) - bħal razza
English: Vasculitis associated in very rare cases with transient renal involvement
Maltese: Vaskulite assoċjata ma' każijiet rari ħafna ta' involviment renali temporanju
English: PHARMACOLOGICAL PROPERTIES
Maltese: FARMAKOLOĠIKU
English: Sweating Pruritus, rash
Maltese: Għaraq Ħakk,Raxx
English: Data were as follows (values in brackets show the 95% confidence intervals):
Maltese: Id-dejta kienet kif ġej (il-valuri fil-parentesi juru l-intervalli ta' kunfidenza ta' 95%):
English: • Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Maltese: (ovalalbumina, proteini tat-tiġieġ) neomycin, formaldehyde u octoxinol 9.
English: 2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Maltese: 2/ ŻOMM IS-SISTEMA TA' MIKROINJEZZJONI BEJN
English: ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
Maltese: ** serokonverżjoni = tajter HI ta' qabel il-vaċċin u tajter HI ta' wara l-vaċċin negattivi ≥ 40, Żieda sinifikanti = tajters HI ta' qabel il-vaċċin pożittiv u mill-inqas żieda ta' 4 darbiet iżjed fit-tajter ta'
English: Children and adolescents IDflu is not recommended for use in children and adolescents below 18 years.
Maltese: IDflu mhuwiex irrakomandat għal-uzu fit-tfal u adolexxenti taħt 18-il sena.
English: IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Maltese: IDflu 15 mikrogrammi/razza suspensjoni għall-injezzjoni Vaċċin ta' kontra l-influwenza (virion maqsum, inattivat)
English: EXP
Maltese: Tieqa
English: Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Maltese: Testijiet għall-HIV-1, il-virus ta' l-epatite Ċ u HTLV-1 jistgħu jkunu affettwati.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02 Immunogenicity
Maltese: J07BB02 Immunoġeniċità
English: Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Maltese: Wara l-vaċċin kontra l-influwenza, riżultati tat-test seroloġiku li jkunu pożittivi-foloz billi jintuża l-metodu ELISA biex ikunu osservati l-antikorpi kontra l-HIV-1, l-Epatite Ċ, u b'mod speċjali, HTLV-1, kienu osservati.
English: INSTRUCTION FOR USE
Maltese: Informazzjoni għall utent
English: Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
Maltese: u 87.9%, ir-rata tas-serokonverżjoni jew żieda sinifikanti varjaw bejn 30.0% u 46.9%, u l-GMTRs varjaw bejn 3.04 u 5.35- darbiet fuq it-tajters HI fil-linja bażi.
English: 0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.1 ml ta' suspensjoni f'siringa mimlija għall-lest (ħġieġ ) b'Sistema ta' Mikro-Injezzjoni, b'labra mikro mwaħħla, mgħammra b'tapp tal-planġer tal-elastomer (chlorobutyl), għatu tat-tarf (elastomer termoplastiku u polypropylene) u sistema tal-protezzjoni tal-labra.
English: Sanofi AB Tel: +46 8-634 50 00
Maltese: Tel: +46 8-634 50 00
English: The recommended dose is 0.1 ml for individuals 60 years of age and over.
Maltese: Id-doża rakkomandata hija 0.1ml f'adulti l-fuq minn 60 sena.
English: Seroprotection is generally obtained within 2 to 3 weeks.
Maltese: Is-seroprotezzjoni ġeneralment tinkiseb fi żmien minn 2 sa 3 ġimgħat.
English: Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré
Maltese: Newralġija, konvulżjonijiet bid-deni, disturbi newroloġiċi bħal enċefalomajelite, u s-sindrome ta'
English: Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Maltese: Profilassi tal-influwenza f'adulti minn 60 sena l-fuq, speċjalment dawk li qegħdin f'riskju miżjud ta'
English: Most of side effects listed above disappeared without treatment within 1 to 3 days after onset.
Maltese: L-akbar parti ta dawn l-effetti sekondarji jisparixxu mingħajr trattament fi 1 sa 3 ijiem wara.