FrancophonIA/ELRC3.0 huggingface dataset:
English: f Rash includes the following PTs: Acne, Dermatitis acneiform, Erythema, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular.
Maltese: Akne, Dermatite akneiforma, Eritema, Raxx, Raxx eritematuż, Raxx ġeneralizzat, Raxx makulari, Raxx makulo-papulari, Raxx papulari.
English: Based on population pharmacokinetic analyses, patient age, race (Asian and non-Asian), gender, and body weight do not have a clinically relevant effect on predicted steady-state exposure of dacomitinib.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, l-età, ir-razza (Asjatiċi u mhux Asjatiċi), is-sess, u l-piż tal-ġisem tal-pazjent ma għandhomx effett klinikament rilevanti fuq il-previżjoni talesponiment fi stat fiss għal dacomitinib.
English: EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4).
Maltese: L-istat tal-mutazzjoni tal-EGFR għandu jiġi stabbilit qabel ma tinbeda t-terapija b'dacomitinib (ara sezzjoni 4.4).
English: Women of childbearing potential who are receiving this medicinal product should use adequate contraceptive methods during therapy and for at least 17 days (5 half-lives) after completing therapy.
Maltese: Nisa li jistgħu joħorġu tqal li jkunu qed jirċievu dan il-prodott mediċinali għandhom jużaw metodi ta' kontraċezzjoni adegwati matul it-terapija u għal mill-inqas 17-il jum (5 half-lives) wara li jtemmu t-terapija.
English: i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Maltese: Dwiefer li jikbru 'l ġewwa, Tibdil fil-kulur tad-dwiefer, Disturb fiddwiefer, Infezzjoni fid-dwiefer, Tossiċità tad-dwiefer, Onikoklażi, Onikoliżi, Onikomadeżi, Paronikja.
English: • Inflammation of the lungs (common, may affect up to 1 in 10 people) Difficulty in breathing, shortness of breath, possibly with a cough or fever.
Maltese: • Infjammazzjoni tal-pulmun (komuni, tista' taffettwa sa persuna waħda minn kull 10) Diffikultà fit-teħid tan-nifs, qtugħ ta' nifs, possibbilment bis-sogħla jew deni.
English: If there is any possibility that you may become pregnant you must use effective contraception during treatment, and for at least 17 days afterwards.
Maltese: Jekk ikun hemm xi possibbiltà li tista' toħroġ tqila għandek tuża kontraċezzjoni effettiva waqt il-kura, u għal mill-inqas 17-il jum wara.
English: Upon recovery to Grade ≤ 1, resume dacomitinib with a reduction of 1 dose level.
Maltese: Mal-irkupru għal Grad ≤ 1, erġa' ibda dacomitinib bi tnaqqis b'livell wieħed tad-doża.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate).
Maltese: Kull pillola miksija b'rita fiha 15 mg ta' dacomitinib (bħala dacomitinib monohydrate).
English: Manufacturer
Maltese: plantari
English: Interstitial lung disease*c
Maltese: Mard tal-interstizju talpulmun*
English: In embryo-foetal development studies in rats and rabbits, pregnant animals received oral doses up to approximately 2.4 times and 0.3 times, respectively, the unbound AUC at the recommended human dose during the period of organogenesis.
Maltese: Fi studji dwar l-iżvilupp embriju-fetali fuq firien u fniek, annimali tqal ingħataw dożi mill-ħalq sa bejn wieħed u ieħor 2.4 darbiet u 0.3 darbiet, rispettivament, l-AUC mhux marbut fid-doża rakkomandata tal-bniedem matul il-perjodu ta' organoġenesi.
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4).
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali metabolizzati b'mod predominanti minn CYP2D6 għandu jiġi evitat (ara sezzjoni 4.4).
English: Stratification factors at randomisation were race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21).
Maltese: Il-fatturi ta' stratifikazzjoni waqt ir-randomizzazzjoni kienu r-razza (Ġappuniżi kontra Ċiniżi kontinentali u Asjatiċi oħra tal-Lvant kontra Asjatiċi mhux tal-Lvant, kif iddikjarat mill-pazjent), u l-istat tal-mutazzjoni tal-EGFR (tħassir tal-exon 19 kontra l-mutazzjoni L858R fl-exon 21).
English: Treatment with dacomitinib should be withheld pending investigation of these symptoms.
Maltese: Il-kura b'dacomitinib għandha titwaqqaf sakemm isiru l-investigazzjonijiet ta' dawn is-sintomi.
English: Table 3 presents adverse reactions for Vizimpro.
Maltese: It-Tabella 3 tippreżenta r-reazzjonijiet avversi għal Vizimpro.
English: In patients who develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted (see section 4.2).
Maltese: F'pazjenti li jiżviluppaw elevazzjonijiet severi fit-transaminase waqt li jkunu qed jieħdu dacomitinib, il-kura għandha tiġi interrotta (ara sezzjoni 4.2).
English: Dacomitinib was tested using a series of genetic toxicology assays.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: From the small number of patients in the moderate group [total bilirubin > 1.5 to 3 × ULN and any AST; N=5], there is no evidence for a change in dacomitinib pharmacokinetics.
Maltese: Mill-għadd żgħir ta' pazjenti fil-grupp b'indeboliment epatiku moderat [bilirubina totali > 1.5 sa 3 × ULN u kwalunkwe AST; N=5], ma hemm l-ebda evidenza ta' tibdil filfarmakokinetika ta' dacomitinib.
English: Rash, erythematous and exfoliative skin conditions have been reported in patients treated with Vizimpro (see section 4.8).
Maltese: Kien hemm rapporti ta' raxx, u ta' kundizzjonijiet eritematużi u esfoljattivi tal-ġilda f'pazjenti li kienu qed jingħataw kura b'Vizimpro (ara sezzjoni 4.8).
English: No starting dose adjustments are required when administering Vizimpro to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża tal-bidu ma huwa meħtieġ meta Vizimpro jingħata lil pazjenti b'indeboliment epatiku ħafif (Child-Pugh tal-Klassi A) jew moderat (Child-Pugh tal-Klassi B).
English: Significant exposure-safety relationship was defined for Grade ≥ 3 rash/dermatitis acneiform, other skin toxicities, diarrhoea and Grade ≥ 1 stomatitis.
Maltese: Relazzjoni sinifikanti bejn l-esponiment-sigurtà ġiet stabbilita għal raxx/dermatite qisha akne, tossiċitajiet oħra tal-ġilda u dijarea tal-Grad ≥ 3 u stomatite tal-Grad ≥ 1.
English: Therefore, the statistical significance of OS improvement could not be formally assessed.
Maltese: Għaldaqstant, issinifikanza statistika tat-titjib fl-OS ma setgħetx tiġi vvalutata b'mod formali.
English: These results suggest that dacomitinib may increase exposure of other medicinal products (or decrease exposure to active metabolites) primarily metabolised by CYP2D6.
Maltese: Dawn ir-riżultati jissuġġerixxu li dacomitinib jista' jżid l-esponiment għal prodotti mediċinali oħrajn (jew inaqqas l-esponiment għallmetaboliti attivi) primarjament metabolizzati minn CYP2D6.
English: However, based on the oral bioavailability of 80%, these membrane transport proteins are unlikely to have any impact on dacomitinib absorption.
Maltese: Madankollu, abbażi tal-bijodisponibilità orali ta' 80%, mhuwiex probabbli li dawn il-proteini trasportaturi talmembrana jkollhom impatt fuq l-assorbiment ta' dacomitinib.
English: Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate.
Maltese: Agħti kura bi prodotti mediċinali kontra d-dijarea (eż., loperamide), u t-teħid ta' fluwidi orali adegwati jew ta' fluwidi jew elettroliti ġol-vina skont kif xieraq.
English: You should have an anti-diarrhoeal medicine available before you start taking Vizimpro.
Maltese: Għandu jkollok mediċina kontra d-dijarea disponibbli qabel tibda tieħu Vizimpro.
English: Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea.
Maltese: Ibda l-kura bi prodotti mediċinali kontra d-dijarea (eż. loperamide) mal-ewwel tfaċċar ta' dijarea.
English: The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea
Maltese: Ir-raġunijiet irrappurtati bl-aktar mod frekwenti (> 5%) għal tnaqqis fid-doża minħabba xi reazzjoni avversa f'pazjenti li kienu qed jirċievu dacomitinib kienu raxx (32.2%), disturbi fid-dwiefer (16.5%), u dijarea (7.5%).
English: Vomiting
Maltese: Ċensurati
English: Following dacomitinib 45 mg daily dosing, steady-state was reached within 14 days.
Maltese: Wara l-għoti ta' dożi ta' 45 mg ta' dacomitinib kuljum, l-istat fiss intlaħaq fi żmien 14-il jum.
English: • Tiredness
Maltese: • Ġilda xotta
English: Based on data from observations in 8 patients in Study A7471001, there was no apparent effect of local antacid administration on Cmax and AUCinf of dacomitinib.
Maltese: Abbażi ta' data minn osservazzjonijiet fuq 8 pazjenti fl-Istudju A7471001, ma kien hemm l-ebda effett apparenti tal-għoti ta' antiaċidu lokali fuq is-Cmax u fuq l-AUC inf ta' dacomitinib.
English: • Alteration in taste
Maltese: Modifiki tad-doża
English: Palmar-plantar erythrodysaesthesia syndrome Skin fissures Dry skin f
Maltese: Tossiċità tal-fwied u żieda fit-transaminase
English: In repeat-dose toxicity studies with dacomitinib, effects on reproductive organs were observed in female rats given approximately 0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to reversible epithelial atrophy in the cervix and vagina.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti b'dacomitinib, kienu osservati effetti fuq l-organi riproduttivi f'firien nisa li ngħataw madwar 0.3 darbiet l-AUC mhux marbut fid-doża rakkomandata tal-bniedem (għal 6 xhur) u kienu limitati għal atrofija epiteljali riversibbli fiċ-ċerviċi u fil-vaġina.
English: Diarrhoea* Stomatitis d
Maltese: Dijarea* Stomatite Rimettar Dardir
English: • Itching
Maltese: • Għeja
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Maltese: Meta jkun qed jiġi vvalutat l-istat tal-mutazzjoni tal-EGFR ta' pazjent, huwa importanti li tintgħażel metodoloġija validata sew u robusta sabiex jiġu evitati determinazzjonijiet negattivi foloz jew pożittivi foloz.
English: Careful assessment of all patients with an acute onset or unexplained worsening of pulmonary symptoms (e.g., dyspnoea, cough, fever) should be performed to exclude ILD/pneumonitis.
Maltese: Għandha ssir valutazzjoni bir-reqqa tal-pazjenti kollha b'bidu akut jew b'aggravar mhux spjegat ta' sintomi pulmonari (eż., qtugħ ta' nifs, sogħla, deni) biex jiġi eskluż ILD/pnewmonite.
English: c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Maltese: c Konġuntivite tinkludi l-PTs li ġejjin:
English: Conjunctivitis b
Maltese: NUMRU(I)
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Maltese: Vizimpro 15 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha dacomitinib monohydrate, ekwivalenti għal 15 mg ta' dacomitinib.
English: In Asian patients, median PFS was 16.5 months for dacomitinib arm and 9.3 months for gefitinib arm.
Maltese: F'pazjenti Asjatiċi, il-PFS medjana kienet 16.5 xhur għall-fergħa ta' dacomitinib u 9.3 xhur għall-fergħa ta' gefitinib.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Maltese: Vizimpro 30 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha dacomitinib monohydrate, ekwivalenti għal 30 mg ta' dacomitinib.
English: Approximately 90% of patients included in this analysis were Asian or White.
Maltese: Madwar 90% tal-pazjenti inklużi f'din l-analiżi kienu Asjatiċi jew Bojod.
English: If you take H2 blocker medicine take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker medicine.
Maltese: Jekk tieħu mediċina li timblokka l-H2 ħu d-doża tiegħek ta' Vizimpro mill-inqas sagħtejn qabel jew 10 sigħat wara li tieħu l-mediċina li timblokka l-H2.
English: 75 mg Solution for injection
Maltese: 75 mg Soluzzjoni għallinjezzjoni
English: 2 pre-filled syringes + 2 alcohol pads
Maltese: 4 siringi mimlijin għallest +4 kuxxinetti blalkoħol
English: MA EU Number (Invented) name
Maltese: Numru tal-MA Isem (ivvintat)
English: Subcutaneous use Pre-filled syringe (glass)
Maltese: Siringa mimlija għal-lest (ħġieġ)
English: 10x1 ml (10 doses).
Maltese: 10x1 ml (10 dożi,).
English: ATCvet code: QI05AI01.
Maltese: Q105A101.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Maltese: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Ilma għall-injezzjonijiet
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation 69800
English: Tetanus component: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCE
Maltese: MERIAL Toulouse 4, chemin du Calquet, 31057 Toulouse Cedex, FRANCE
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Maltese: MERIAL, Laboratorju ta' Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon,
English: Date of first authorisation: 6/03/2003 Date of last renewal: 6/03/2013
Maltese: Data tal-ewwel awtorizzazzjoni: 06/03/2003 Data tal-aħħar tiġdid: 06/03/2013
English: Carbomer ......................................................................................................................................... 4 mg.
Maltese: Carboner ............................................................................................................................................ 4 mg
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP.
Maltese: * Il-kontenut tal-vCP iċċekjat bil-FAID50 globali (doża infettiva florexxenti ta' prova 50 %) u r-ratio qPCR bejn vCP.
English: • Store and transport refrigerated (2 °C - 8 °C).
Maltese: • Aħżen u ttrasporta fil-friġġ 2 °C-8 °C.
English: As a consequence, these components induce immunity against equine influenza virus (H3N8).
Maltese: Konsegwentement, dawn il-komponenti jinduċu immunità kontra l-virus tal influwenza fiż-żwiemel (H3N8).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Carbomer ......................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Maltese: Carboner ............................................................................................................................................ 4 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Veterinary medicinal product subject to prescription.
Maltese: Prodott mediċinali veterinarju bil-preskrizzjoni.
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Maltese: L-istrejns vCP2242 u vCP3011 tal-vaċċin huma virusijiet rikombinati tal-canarypox li jesprimu ilġene hæmagglutinin HA mill-istrejns tal-virus tal-influwenza fiż-żwiemel A/eq/Ohio/03 (strejn Amerikan, Florida sublineage clade 1), u A/eq/Richmond/1/07 (strejn Amerikan, Florida sublineage clade 2) rispettivament.
English: Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ............................................................. ≥ 5.3 log10 FAID50 Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) .................................................. ≥ 5.3 log10 FAID50 Clostridium tetani toxoid ............................................................................................................. ≥ 30 IU
Maltese: Influenza A/eq Ohio/03 {H3N8}virus rikombinat tal-canarypox (vCP2242) ...........≥ 5.3 log 10 FAID50* Influenza A/eq/Richmond/1/07 {H3N8} virus rikombinat tal-canarypox (vCP3011) ............................................................................................. 5.3 log10 FAID50* Clostridium tetani toxoid........................................................................................................... > 30 IU**
English: Influenza A/eq/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU**
Maltese: Influenza A/eq/ Ohio/03 {H3N8}virus rikombinat tal-Canarypox (vCP2242) ......... ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 {H3N8} virus rikombinat tal-Canarypox (vCP3011)......................................................................................... ≥ 5.3 log10 FAID50* Clostridium tetani toxoid........................................................................................................... > 30 IU**
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Maltese: Hemm informazzjoni ta' sigurtà u effikaċja li turi li din it-tilqima tista' tiġi amministrata fl-istess jum iżda f'postijiet differenti u mhux imħallta mal-vaċċin inattivat tal-MERIAL kontra r-rabbja.
English: The vaccine stimulates active immunity against equine influenza and tetanus.
Maltese: Il-vaċċin jistimula immunità kontra l-influwenza u t-tetnu fiż-żwiemel.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma' prodott mediċinali veterinarju ieħor
English: Influenza component: MERIAL
Maltese: EFFETTI MHUX MIXTIEQA
English: In rare occasions, swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks,
Maltese: F'okkażjonijet rari n-nefħa tistà tilħaq dijametru ta' 15-20 cm, li ddum minn 2-3 ġimgħat, li tistà tirrekjedi kura sintomatika
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Maltese: F'każ li jiżdied ir-riskju ta' infezzjoni jew jekk ma jkunx hemm kolostrum suffiċjenti, injezzjoni oħra fil-bidu ta' ProteqFlu-Te tista' tingħata ta' 4 xhur segwita mill-programm komplet ta' tilqim (l-ewwel kors ta' tilqim ta' 5-6 xhur u 4-6 ġimgħat wara segwit mit-tieni kors).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu).
English: One dose of 1 ml contains:
Maltese: Il-komponent tal-Influwenza:
English: PACKAGE LEAFLET FOR: ProteqFlu-Te suspension for injection for horses
Maltese: FIL-PAKKETT ProteqFlu-Te suspensjoni għall-injezzjoni għaż-żwiemel.
English: Intramuscular use (preferably in the neck region).
Maltese: Għall-użu fil-muskolu (preferribilment fl-għonq).
English: ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
Maltese: ** titolu ta' antikorp antitossiku indott wara tilqim ripetut fis-sera tal-fenek tal-Indi skond il-Ph.Eur.
English: ProteqFlu-Te Suspension for injection for horses
Maltese: ProteqFlu-Te suspensjoni għall-injezzjoni għaż-żwiemel.
English: Type I glass vial.
Maltese: Għall-użu fil-muskolu.
English: Butyl elastomer closure and aluminium cap.
Maltese: Aqra l-fuljett tal-pakett qabel l-użu.
English: • Followed by: o against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.
Maltese: • Segwit minn: o kontra t-tetnu: injezzjoni ta' doża waħda f'intervalli sa mhux aktar minn sentejn bilProteqFlu-Te.
English: • In very rare occasions, abscessation may be observed.
Maltese: • F'każi rari ħafna tista tiġi osservata l-materja.
English: Box of 10 vials of 1 dose.
Maltese: Kaxxa ta' 10 kunjetti ta' doża waħda.
English: The periodic safety update report (PSUR) cycle would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Maltese: Iċ-ċiklu tar-rapport perjodiku aġġornat tas-sigurta` (PSUR) għandu jerġa jinbeda kull 6 xhur għallsottomissjoni tar-rapporti (li jkopru kull preżentazzjoni awtorizzata tal-prodott) għal sentejn, segwit b'rapporti annwali għas-sentejn sussegwenti u wara f'perjodi ta' 3 snin.
English: Suspension for injection.
Maltese: Suspensjoni għall-injezzjoni għaż-żwiemel.
English: Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus.
Maltese: Bidu tal-immunità indotta mill-iskema ta' tilqim: - 5 xhur wara l-ewwel kors ta' tilqim; - wara l-ewwel kors ta' tilqim u l-injezzjoni booster 5 xhur wara; sena fil-każ tal-influwenza ekwina u sentejn fil-każ tat-tetnu.
English: o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
Maltese: o kontra l-influwenza ekwina: injezzjoni ta' doża waħda kull sena, jew bil-ProteqFlu inkella bil-ProteqFlu-Te, u jinżamm intervall ta' mhux aktar minn sentejn għall komponent tat-tetnu.
English: • Do not use after the expiry date stated on the label.
Maltese: • Tużax wara d-data tal-iskadenza fuq it-tikketta.
English: Manufacturer for the batch release: MERIAL
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq: MERIAL,
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U LMANIFATTUR RESPONSABBLI
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: 18-il xahar.
English: Gastrointestinal symptoms i,§
Maltese: Sintomi gastrointestinali i,§
English: Loc. Fontana del Ceraso Anagni, 03012
Maltese: Fontana del Ceraso Anagni, 03012
English: Bristol Myers Squibb S.r.l.
Maltese: Bristol Myers Squibb S.r.l. Loc.
English: Diabetic ketoacidosis b,k,l
Maltese: Ketoaċidożi dijabetika b,k,l
English: Similar reductions were observed at up to 104 weeks.
Maltese: Tnaqqis simili ġie osservat f'sa 104 ġimgħat.
English: CI=confidence interval.
Maltese: CI=intervall ta' kunfidenza.