FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Ebixa for adults and older people is four pump actuations, equivalent to 20 mg once a day.
Maltese: Id-doża rakkomandata ta' Ebixa għall-adulti u persuni akbar fl-età hija ta' erba' attwazzjonijiet bilpompa, ekwivalenti għal 20 mg darba kuljum.
English: Ebixa 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Maltese: Pilloli ħomor ċari għal ħomor griżi, miksijin b'rita b'forma ovali-oblong u b'intaljar ta' “20” fuq naħa waħda u “MEM” fuq in-naħa l-oħra.
English: From Week 4 on The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day.
Maltese: Il-pazjent għandu jieħu 2 ml ta' soluzzjoni (20 mg) ekwivalenti għal erba' attwazzjonijiet bil-pompa darba kuljum.
English: Week 2 (day 8-14) The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days.
Maltese: Il-pazjent għandu jieħu 1 ml ta' soluzzjoni (10 mg) ekwivalenti għal żewġ attwazzjonijiet bil-pompa kuljum għal 7 t'ijiem.
English: Week 3 (day 15-21) The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Maltese: Ħu pillola miksija b'rita waħda kuljum ta' 15 mg (oranġjo-griża, ovali-oblong ) għal 7 t'ijiem.
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
Maltese: • Għeja, infezzjonijiet tal-moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali,
English: EU/1/02/219/005-006 EU/1/02/219/013
Maltese: EU/1/02/219/005-006
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone beeing reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Pharmacotherapeutic group: Psychoanaleptics.
Maltese: Dan il-prodott mediċinali fih ukoll sorbitol.
English: Ebixa 10 mg film-coated tablets Ebixa 20 mg film-coated tablets
Maltese: Ebixa 10 mg pilloli miksijin b'rita Ebixa 15 mg pilloli miksijin b'rita Ebixa 20 mg pilloli miksijin b'rita Memantine hydrochloride
English: Administration of Ebixa is not recommended in patients with severe hepatic impairment.
Maltese: It-teħid ta' Ebixa mhux rakkomandat f'pazjenti li għandhom indeboliment epatiku sever.
English: Week 1 (day 1-7) The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.
Maltese: Il-pazjent għandu jieħu 0.5 ml ta' soluzzjoni (5 mg) ekwivalenti għal attwazzjoni bil-pompa waħda kuljum għal 7 t'ijiem.
English: Ebixa 10 mg film-coated tablets.
Maltese: Ebixa 10 mg pillola miksija b'rita.
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi tal bilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini
English: EXP {MM.YYYY}
Maltese: JIS {XX.SSSS}
English: Multipack: 1000 ( 20 packs of 50) film-coated tablets
Maltese: Pakkett multiplu: 980 (10 pakketti ta' 98) pillola miksija b'rita Pakkett multiplu: 1000 (20 pakkett ta' 50) pillola miksija b'rita
English: For detailed instructions on the preparation and handling of the product see section 6.6.
Maltese: Għal istruzzjonijiet dettaljati dwar il-preparazzjoni u l-immaniġġar tal-prodott ara sezzjoni 6.6
English: Additional for 20 mg film-coated tablets: Irion oxide yellow and red
Maltese: Bħala żieda mal-pilloli miksijin b'rita ta' 20 mg: Iron oxide isfar u aħmar
English: The clinical relevance of these findings is unknown.
Maltese: Ir-rilevanza klinika ta'
English: 2013/2014 season
Maltese: Staġun 2013/2014
English: ………………………………………...…………………………per 0.2 ml dose
Maltese: .......................................................................................................f'kull doża ta' 0.2 ml
English: B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)
Maltese: B/Massachusetts/2/2012 razza qisha (B/Massachusetts/2/2012, MEDI 237751)
English: Pack size of 10.
Maltese: Daqs tal-pakkett ta' 10.
English: D153-P514 Europe 6 to 71 M 2,085 2002-2003
Maltese: D153-P514 Ewropa 6 sa 71 X 2,085 2002-2003
English: Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK
Maltese: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, Ir-Renju Unit
English: The influenza virus strains in FLUENZ are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Maltese: Ir-razez tal-virus tal-influwenza fi FLUENZ huma (a) adattati skond il-ksieħ (cold-adapted, ca); (b) sensittivi għat-temperatura (temperature-sensitive, ts); u (ċ) attenwati (attenuated, att).
English: 6 to 35 M 2,107
Maltese: 6 sa 35 X 2,107
English: A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514)
Maltese: A/Victoria/361/2011 razza qisha (H3N2) (A/Texas/50/2012, MEDI 237514)
English: Fluenz is a trademark of MedImmune, LLC.
Maltese: Fluenz hi marka reġistrata ta' MedImmune, LLC.
English: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Netherlands
Maltese: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen L-Olanda
English: Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting.
Maltese: Rapporti rari ħafna tas-sindrome ta' Guillain-Barré u aggravament ta' sintomi tas-sindrome ta' Leigh (enċefalomijopatija mitokondrijali) kienu wkoll osservati fl-isfond ta' wara t-tqegħid fis-suq.
English: M = months.
Maltese: S=snin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 January 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Jannar 2011
English: Efficacy (95% CI)
Maltese: Effikaċja (95% CI)
English: MedImmune, LLC 297 North Bernardo Avenue, Moutain View
Maltese: MedImmune, LLC 297 North Bernardo Avenue, Mountain View California, 94043
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002 < - 10 sprayers>
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/661/002 <10 sprayers >
English: Very rare (may affect up to 1 in 1,000,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 persuna minn kull 1,000,000):
English: Other possible side effects of Fluenz
Maltese: Effetti sekondarji oħra possibbli ta' Fluenz
English: Latin America
Maltese: Afrika, Amerika Latina
English: However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Maltese: Madankollu, ibbażat fuq il-potenzjal li mediċini antivirali kontra l-influwenza jnaqqsu l-effettività ta' FLUENZ, hu rakkomandat li t-tilqima ma tingħatax sa 48 siegħa wara l-waqfien tat-terapija antivirali kontra l-influwenza.
English: Figure 1 FLUENZ Administration
Maltese: Figura 1 L-Għoti ta' FLUENZ
English: e The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Maltese: e Ir-razza primarja li kienet qed tiċċirkola kienet dissimili b'mod antigeniku mir-razza H3N2 irrappreżentata fit-tilqima; l-effikaċja kontra r-razza mhux imqabbla A/H3N2 kienet ta' 85.9% (95% CI: 75.3, 91.9).
English: Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Maltese: Dibasic potassium phosphate Monobasic potassium phosphate Ġelatina (porcine, Tip A) Arginine hydrochloride Monosodium glutamate monohydrate Ilma għall-injezzjonijiet
English: 10 single-use nasal applicators (0.2 ml each)
Maltese: 10 applikaturi ta' l-imnieħer li jintużaw darba biss (0.2 ml kull wieħed)
English: Improved Efficacy (95% CI)
Maltese: Effikaċja Mtejba (95% CI)
English: Do not administer FLUENZ to children and adolescents younger than 18 years of age receiving salicylate therapy (see section 4.3).
Maltese: Tagħtix FLUENZ lil tfal u adolexxenti li jkollhom inqas minn età ta' 18-il sena li jkunu qed jirċievu terapija b'salicylate (ara sezzjoni 4.3).
English: NAME OF THE MARKETING AUTHORISATION HOLDER MedImmune, LLC
Maltese: FIS-SUQ MedImmune, LLC
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal) 2013/2014 season
Maltese: TAL-PRODOTT MEDIĊINALI FLUENZ sprej għall-imnieħer, suspensjoni Tilqima kontra l-influwenza (ħajja attenwata, nażali) Staġun 2013/2014
English: Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Netherlands, (Tel) +31 24 371 7310
Maltese: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, L-Olanda, (Tel) +31 24
English: Other medicines, other vaccines and Fluenz
Maltese: Mediċini oħra, tilqim ieħor u Fluenz
English: 11 to 24 M 1,150 2002-2003 78.4%
Maltese: 11 sa 24 X 1,150 2002-2003 78.4% D153-P501 Asja/Oċeanja 12 sa 35 X 2,764
English: How to store Fluenz
Maltese: M'intix ser tingħata Fluenz
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin).
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (eż. ġelatina) jew għal gentamicin (residwu-traċċa possibbli), bajd jew proteini tal-bajd (eż. ovalbumin).
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Maltese: ċ Dejta ppreżentata għal prova klinika D153-P504 hi għal parteċipanti fl-istudju li rċivew żewġ dożi tat-tilqima tal-istudju.
English: • The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril.
Maltese: • Id-doża rakkomandata għat-tfal u adolexxenti hi ta' 0.2 ml ta' Fluenz, li tingħata bħala 0.1 ml f'kull minfes.
English: FLUENZ is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Maltese: FLUENZ hu fornut bħala 0.2 ml ta' suspensjoni f'applikatur ta' l-imnieħer li jintuża darba biss (ħġieġ ta' Tip 1), b'żennuna (tal-polypropylene b'valv tal-polyethylene għat-trasferiment), żennuna b'għatu għal protezzjoni tat-tarf (tal-lastku sintetiku), lasta tal-planġer, tapp tal-planġer (lastku tal-butyl), u klipp li taqsam id-doża.
English: In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% FLUENZ versus 3.8% injectable influenza vaccine).
Maltese: Fl-istess studju, kienet osservata żieda fir-rata ta' tħarħir sa 42 jum fi tfal żgħar u trabi li kellhom età ta' 6-23 xahar (5.9% FLUENZ kontra 3.8% għat-tilqima kontra l-influwenza li tista' tiġi injettata).
English: FLUENZ's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Maltese: Dejta dwar l-effikaċja ta' FLUENZ fil-popolazzjoni pedjatrika tikkonsisti f'9 studji kkontrollati li kienu jinkludu iżjed minn 20,000 tfal żgħar u trabi, tfal u adolexxenti, li twettqu matul 7 staġuni ta' influwenza.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/661/002
English: In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% FLUENZ versus 2.6% injectable influenza vaccine).
Maltese: Fi studju kliniku kkontrollat b'mod attiv (MI-CP111), kienet osservata żieda fir-rata ta' pazjenti li kellhom jiddaħħlu l-isptar (minħabba kwalunkwe kawża) sa 180 jum wara d-doża tat-tilqima finali fi tfal żgħar u trabi li kellhom età ta' 6-11-il xahar (6.1% FLUENZ kontra 2.6% għat-tilqima kontra l-influwenza li tista' tiġi injettata).
English: Prophylaxis of influenza in individuals 24 months to less than 18 years of age.
Maltese: Profilassi tal-influwenza f'individwi minn età ta' 24 xahar sa inqas minn 18-il sena.
English: Adverse reaction frequencies are reported as: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Very rare (< 1/10,000)
Maltese: Mhux komuni ≥ 1/1,000 sa < 1/100)
English: Contains also: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Maltese: Fih ukoll: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, ġelatina (porcine, Tip A), arginine hydrochloride, monosodium glutamate monohydrate, ilma għal injezzjonijiet.
English: • Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
Maltese: • Tfal li fil-passat ma jkunux ingħataw tilqima kontra l-influwenza ser jirċievu t-tieni doża follow-up wara intervall ta' mill-inqas 4 ġimgħat.
English: Safety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies.
Maltese: Dejta dwar is-sigurtà fir-rigward tal-użu ta' FLUENZ ġiet ikkompilata minn aktar minn 28,500 tfal u adolexxenti li kellhom minn età ta' sentejn sa 17-il sena minn studji kliniċi u minn aktar minn 52,500 tfal u adolexxenti minn studji dwar is-sigurtà wara li nħarġet l-awtorizzazzjoni.
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz.
Maltese: Staqsi lit-tabib, lill-infermiera jew lill-ispiżjar tiegħek jekk tixtieq aktar informazzjoni dwar l-effetti sekondarji possibbli minn Fluenz.
English: • if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”).
Maltese: • jekk inti allerġiku għal bajd, proteini tal-bajd, gentamicin, jew ġelatina, jew sustanzi oħra ta' Fluenz (dawn huma elenkati f'sezzjoni 6 “Kontenut tal-pakkett u informazzjoni oħra”).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Virus tal-influwenza reassortant* (ħaj attenwat) tar-razez li ġejjin**: A/California/7/2009 razza qisha (H1N1)pdm09 (A/California/7/2009, MEDI 228029)
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)
Maltese: U KWANTITATTIVA Virus tal-influwenza reassortant* (ħaj attenwat) tar-razez li ġejjin**: A/California/7/2009 razza qisha (H1N1)pdm09 (A/California/7/2009, MEDI 228029)
English: FLUENZ demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,659 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
Maltese: ċ FLUENZ wera 55.7% (39.9, 67.6) inqas każijiet minn tilqima kontra l-influwenza li tista' tiġi injettata fi 3,659 tfal żgħar u trabi li kellhom età ta' 6-23 xahar u 54.4% (41.8, 64.5) inqas każijiet f'4,166 tfal li kellhom età ta' 24-59 xahar. d FLUENZ wera 64.4% (1.4, 88.8) inqas każijiet minn tilqima kontra l-influwenza li tista' tiġi injettata f'476 tfal żgħar u trabi li kellhom età ta' 6-23 xahar u 48.2% (12.7, 70.0) inqas każijiet f'1,579 tfal li kellhom età ta' 24-71 xahar.
English: You can breathe normally while you are given Fluenz.
Maltese: Tista' tieħu n-nifs normalment waqt li tkun qed tingħata Fluenz.
English: Pregnancy There are limited data from the use of FLUENZ in pregnant women.
Maltese: Tqala Hemm dejta limitata dwar l-użu ta' FLUENZ f'nisa tqal.
English: It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age.
Maltese: Mhux rakkomandat li tagħti FLUENZ lil tfal żgħar u trabi li jkollhom età ta' 12-23 xahar.
English: (24.6, 70.5)d fewer cases than injectable
Maltese: (45.4, 62.9)ċ inqas każijiet minn dawk li jistgħu jiġu injettati
English: • if you are under 18 years of age and already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Maltese: • jekk għandek inqas minn età ta' 18-il sena u diġà qed tieħu acetylsalicylic acid (sustanza li tinsab f'ħafna mediċini li tintuża għas-solliev tal-uġigħ u biex tnaqqas id-deni).
English: FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Maltese: FLUENZ mhuwiex kontraindikat għall-użu f'individwi b'infezzjoni HIV asintomatika; jew individwi li jkunu qed jirċievu kortikosterojdi topiċi/li jinġibdu man-nifs jew doża baxxa ta' kortikosterojdi sistemiċi jew dawk li jkunu qed jirċievu kortikosterojdi bħala terapija ta' sostituzzjoni, eż. għal insuffiċjenza adrenali.
English: 5 single-use nasal applicators (0.2 ml each) Store in a refrigerator.
Maltese: 5 applikaturi ta' l-imnieħer li jintużaw darba biss (0.2 ml kull wieħed) Aħżen fi friġġ.
English: • muscle aches
Maltese: TWISSIJA(IET) SPEĊJALI
English: Efficacy (95% CI)b Matched strains
Maltese: Effikaċja Mtejba (95% CI)b Razez li Jaqblu
English: Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Maltese: Tfal u adolexxenti li huma klinikament immunodefiċjenti minħabba kundizzjonijiet jew terapija immunosoppressiva bħal: lewkimji akuti u kroniċi; limfoma; infezzjoni sintomatika bl-HIV; defiċjenzi immuni ċellulari; u doża qawwija ta' kortikosterojdi.
English: Summary of adverse reactions
Maltese: Sommarju ta' reazzjonijiet avversi
English: D153-P502 Europe c c
Maltese: D153-P502 Ewropa
English: In a clinical study, an increased rate of wheezing was observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8).
Maltese: Fi studju kliniku, kienet osservata żieda fir-rata ta' tħarħir fi tfal żgħar u trabi li kellhom età ta' 12-23 xahar wara t-tilqima (ara sezzjoni 4.8).
English: Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Maltese: Tfal u adolexxenti li jkollhom inqas minn età ta' 18-il sena li jkunu qed jirċievu terapija b'salicylate minħabba assoċjazzjoni tas-sindrome ta' Reye b'salicylates u infezzjoni b'influwenza wild-type.
English: The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Maltese: L-użu fl-istess ħin ta' FLUENZ ma' mediċini antivirali li huma attivi kontra l-viruses tal-influwenza A u/jew B ma ġiex evalwat.
English: Region Age Range a
Maltese: 18-il ġimgħa.
English: PHARMACEUTICAL FORM AND CONTENTS Nasal spray, suspension
Maltese: U KONTENUT Sprej għall-imnieħer, suspensjoni
English: Several studies against placebo have shown that FLUENZ may have some efficacy in adults.
Maltese: Diversi studji kontra l-plaċebo wrew li FLUENZ jista' jkollu xi effikaċja f'persuni adulti.
English: Fluenz is a vaccine to prevent influenza (flu).
Maltese: Fluenz hu tilqima għal prevenzjoni tal-influwenza.
English: Do not use salicylates in children and adolescents younger than 18 years of age for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Maltese: Tużax salicylates fi tfal u adolexxenti li jkollhom inqas minn età ta' 18-il sena għal 4 ġimgħat wara t-tilqima ħlief jekk ikun indikat medikament, għax is-sindrome ta' Reye ġie rrappurtat wara l-użu ta' salicylates waqt infezzjoni b'influwenza wild-type.
English: Name and address of the manufacturers of the biological active substance(s)
Maltese: Isem u indirizz tal-manifatturi tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA DAQS TAL-PAKKETT TA' 10 APPLIKATURI TA' L-IMNIEĦER LI JINTUŻAW DARBA BISS (2 X 5
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal)
Maltese: IL-PRODOTT MEDIĊINALI FLUENZ sprej għall-imnieħer, suspensjoni Tilqima kontra l-influwenza (ħajja attenwata, nażali)
English: Instructions for health professionals
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Fluenz nasal spray suspension Influenza vaccine (live attenuated, nasal)
Maltese: Fluenz sprej għall-imnieħer, suspensjoni Tilqima kontra l-influwenza (ħajja attenwata, nażali)
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Maltese: Din it-tilqima hi ppreżentata bħala suspensjoni ta' sprej għall-imnieħer f'applikatur ta' l-imnieħer li jintuża darba biss (0.2 ml) f'daqs tal-pakkett ta' 10.
English: Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Maltese: Dawk li jingħataw it-tilqima għandhom jiġu infurmati li FLUENZ hu tilqima ta' virus ħaj attenwat u għandu l-potenzjal għal trasmissjoni lil kuntatti immunokompromessi.
English: Matched strains
Maltese: TAGĦRIF
English: Efficacy (95% CI)b All strains regardless of match
Maltese: Effikaċja (95% CI)b Razez li Jaqblu
English: *** fluorescent focus units
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (GMOs). *** unitajiet fokus fluworexxenti (fluorescent focus units)
English: FLUENZ has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Maltese: FLUENZ wera superjorità fi 3 studji kkontrollati b'mod attiv b'tilqima kontra l-influwenza li tista' tiġi injettata.
English: Fluenz will be administered under the supervision of a doctor, nurse or pharmacist.
Maltese: Fluenz se jingħata taħt is-superviżjoni ta' tabib, infermiera jew spiżjar.
English: D153-P513 Asia/ Oceania
Maltese: D153-P515 Ewropa
English: Fertility No data exist regarding the possible effects of FLUENZ on male and female fertility.
Maltese: Fertilità Ma teżisti l-ebda dejta dwar l-effetti possibbli ta' FLUENZ fuq il-fertilità tal-irġiel u tan-nisa.
English: In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8).
Maltese: Fi studju kliniku, kienet osservata żieda fir-rata ta' tfal żgħar u trabi iżgħar minn 12-il xahar li kellhom jiddaħħlu l-isptar wara t-tilqima (ara sezzjoni 4.8).
English: • Refer to the FLUENZ administration diagram (Figure 1) for step-by-step administration instructions.
Maltese: • Irreferi għad-dijagramma tal-għoti ta' FLUENZ (Figura 1) għall-istruzzjonijiet tal-għoti pass pass.
English: DO NOT INJECT FLUENZ.
Maltese: TINJETTAX FLUENZ.
English: Table 1 FLUENZ Efficacy in Placebo Controlled Paediatric Studies
Maltese: Kif jidger Fluenz u l-kontenut tal-pakkett