FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of perampanel have not been formally evaluated in patients with renal impairment.
Maltese: Il-farmakokinetika ta' perampanel ma ġietx evalwata b'mod formali f'pazjenti b'indeboliment tal-kliewi.
English: Each film-coated tablet contains 10 mg perampanel.
Maltese: Kull pillola fiha 10 mg ta' perampanel.
English: EU/1/12/776/008 EU/1/12/776/009 EU/1/12/776/010 EU/1/12/776/021
Maltese: EU/1/12/776/008 EU/1/12/776/009 EU/1/12/776/010
English: Clobazam No influence
Maltese: Clobazam L-ebda influwenza
English: The effect of perampanel on human fertility has not been established.
Maltese: Ma kien hemm l-ebda effetti fuq il-fertilità tal-irġiel.
English: When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions.
Maltese: Meta jingħata ma' ikla b'ħafna xaħam, is-Cmax u l-AUC0-inf ta' doża waħda ta' 12 mg ta' suspensjoni orali perampanel kienu madwar 22% u 13%, rispettivament, iktar baxxi meta mqabbla ma' kundizzjonijiet ta' stat sajjem.
English: In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined oral contraceptive, Fycompa was shown to decrease the levonorgestrel exposure (mean Cmax and AUC values were each decreased by 40%).
Maltese: F'nisa b'saħħithom li jkunu qed jirċievu 12 mg (iżda mhux 4 jew 8 mg/kuljum) għal 21 jum fl-istess ħin ma' kontraċettiv orali kombinat, intwera li Fycompa jnaqqas l-esponiment għal levonorgestrel (medja tas-Cmax u l-valuri tal-AUC kienu t-tnejn imnaqqsa b'40%).
English: Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Maltese: L-effett t'indutturi ta' ċitokrom P450 fuq il-farmakokinetika ta' perampanel
English: Each film-coated tablet contains 12 mg perampanel.
Maltese: Kull pillola fiha 12 mg ta' perampanel.
English: In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti adolexxenti fl-istudji kliniċi ta' Fażi 3, ma kien hemm l-ebda differenzi notevoli bejn din il-popolazzjoni u l-popolazzjoni globali.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical trials, perampanel clearance was not influenced by creatinine clearance.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti li kellhom bidu t'aċċessjonijiet parzjali li kellhom tneħħija tal-kreatinina li varjat minn 39 sa 160 mL/min u li kienu qed jirċievu doża ta' perampanel sa 12 mg/kuljum fi studji kliniċi kkontrollati bi plaċebo, it-tneħħija ta' perampanel ma kinitx influwenzata mit-tneħħija tal-kreatinina.
English: EU/1/12/776/002 EU/1/12/776/003 EU/1/12/776/004 EU/1/12/776/019
Maltese: EU/1/12/776/002 EU/1/12/776/003 EU/1/12/776/004
English: Abuse potential
Maltese: Potenzjal ta' abbuż
English: Fycompa contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Fycompa fih il-lactose, u għalhekk pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Maltese: Kemm tieħu Id-doża normali tal-bidu hi ta' 2 mg (4 ml) darba kuljum qabel ma tmur torqod.
English: The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent patients.
Maltese: L-effikaċja ta' perampanel f'aċċessjonijiet li jibdew parzjalment ġiet stabbilita fi tliet studji multiċentriċi addizzjonali ta' terapija ta' 19-il ġimgħa, li fihom il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo, f'pazjenti adulti u adolexxenti.
English: Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective.
Maltese: Fycompa jista' jikkawża li ċerti kontraċettivi ormonali, bħal levonorgestrel, isiru inqas effettivi.
English: AED coadministered
Maltese: AED mogħti flimkien
English: - DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Maltese: - DRESS tipikament, għalkemm mhux eslussivament, tidher bħala sintomi qishom influwenza u raxx flimkien ma' temperatura għolja tal-ġisem, żieda fil-livelli tal-enzimi tal-fwied osservati fittestijiet tad-demm u żieda f'tip ta' ċellula tad-demm bajda (eosinofilija) u tkabbir tal-għoqod tallimfa.
English: Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Maltese: Riżultati simili ġew osservati meta laċċessjonijiet kollha u n-nuqqas vs. aċċessjonijiet mijokloniċi ġew evalwati maż-żmien.
English: - Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa.
Maltese: - Mediċini antiepilettiċi oħrajn bħal carbamazepine, oxcarbazepine, u phenytoin li jintużaw għal kura ta' aċċessjonijiet, jistgħu jaffettwaw lil Fycompa.
English: In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji li kienu qed jirċievu perampanel sa 8 mg/jum fi studju kliniku kkontrollat bi plaċebo, it-tneħħija ta' perampanel ma ġietx influwenzata mit-tneħħija tal-kreatinina fil-linja bażi.
English: The t½ was longer in mildly impaired (306 h vs. 125 h) and moderately impaired (295 h vs. 139 h) subjects compared to matched healthy subjects.
Maltese: It-t1/2 kienet itwal f'persuni b'indeboliment ħafif (306 sigħat vs 125 siegħa) u f'persuni b'indeboliment moderat (295 siegħa vs 139 siegħa) meta paragunati ma' individwi f'saħħithom imqabbla.
English: Open label extension phase
Maltese: Fażi ta' estensjoni open label
English: In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures.
Maltese: Barra minn hekk, analiżi farmakokinetikafarmakodinamika (effikaċja) twettqet fi prova waħda dwar l-effikaċja waħda għal aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji.
English: In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
Maltese: Inibizzjoni ta' enzimi li jimmetabolizzaw il-mediċina F'mikrożomi tal-fwied tal-bniedem, perampanel (30 µmol/l) kellu effett inibitorju dgħajjef fuq CYP2C8 u UGT1A9 fost CYPs u UGTs ewlenin tal-fwied.
English: Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali (mediċini mhux antiepilettiċi) li jinduċu jew li ma jinduċux ċitokrom P450
English: Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Maltese: Reazzjoni talmediċina b'eosinofilija u sintomi sistemiċi (DRESS, Drug Reaction with
English: In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Maltese: Fiż-żewġ analiżijiet, l-espożizzjoni ta' perampanel hi korrelata ma' tnaqqis fil-frekwenza ta' aċċessjonijiet.
English: Each ml of oral suspension contains 0.5 mg perampanel
Maltese: Kull ml ta' suspensjoni orali fih 0.5 mg ta' perampanel.
English: Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations and the potential for higher plasma concentrations of reactive metabolites in their presence has not been excluded.
Maltese: Indutturi b'saħħithom oħrajn ta' ċitokrom P450, bħal rifampicin u hypericum, huma mistennija li jnaqqsu l-konċentrazzjonijiet ta' perampanel u l-potenzjal għal konċentrazzjonijiet ogħla ta' metaboliti reattivi fil-plażma fil-preżenza tagħhom ma setax jiġi eskluż.
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Maltese: Id-doża tista' tiżdied skont irrispons kliniku u t-tollerabilità f'inkrementi ta' 2 mg (4 ml) (jew kull ġimgħa jew kull ġimagħtejn skont il-konsiderazzjonijiet tal-half-life deskritti hawn taħt) għal doża ta' manteniment ta' 4 mg/kuljum (8 ml/jum) sa 8 mg/kuljum (16 ml/jum).
English: Drug metabolising enzyme inhibition
Maltese: Studji dwar interazzjonijiet tal-mediċina
English: Behavioural and reproductive development of the offspring was not affected, but some parameters of physical development showed some delay, which is probably secondary to the pharmacology-based CNS effects of perampanel.
Maltese: L-iżvilupp fl-imġiba u riproduttiv tal-frieħ ma ġiex affettwat, iżda xi parameteri tal-iżvilupp fiżiku wrew xi dewmien, u dan hu probabbilment dovut għall-effetti fuq is-CNS ibbażati farmakoloġikament ta' perampanel.
English: PC: SN: NN:
Maltese: Data meta nfetaħ:
English: Perampanel is readily absorbed after oral administration with no evidence of marked first--pass metabolism.
Maltese: Perampanel jiġi assorbit fil-pront wara l-għoti mill-ħalq mingħajr l-ebda evidenza ta' metaboliżmu first-pass.
English: Ataxia
Maltese: Tqala
English: Push plunger of oral syringe completely down.
Maltese: Imbotta l-planġer tas-siringa tal-ħalq kompletament 'l isfel.
English: Fycompa 12 mg film-coated tablets 12 mg - packs of 7, 28, 84 and 98
Maltese: Fycompa 12 mg pilloli miksija b'rita 10 mg - pakketti ta' 7, 28, 84 u 98.
English: EU/1/12/776/014 EU/1/12/776/015 EU/1/12/776/016 EU/1/12/776/023
Maltese: EU/1/12/776/016 EU/1/12/776/023
English: Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
Maltese: Ġiet irrappurtata mġiba aggressiva u ostili f'pazjenti li jirċievu terapija b'perampanel.
English: The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, demographically matched subjects.
Maltese: Il-farmakokinetika ta' perampanel wara doża waħda ta' 1 mg, ġiet evalwata fi 12-il persuna li kellhom indeboliment ħafif u moderat tal-fwied (Child-Pugh A u B, rispettivament) meta mqabbla ma' 12-il individwu b'saħħithom li kienu mqabbla b'mod demografiku.
English: Hepatic impairment
Maltese: Disturbi psikjatriċi
English: Caution should be exercised when combining Fycompa oral suspension with other antiepileptic medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect absorption of some drugs.
Maltese: Għandu jkun hemm kawtela meta tikkombina Fycompa suspensjoni orali ma' mediċini oħrajn kontra l-epilessija li jkun fihom sorbitol, billi t-teħid kombinat ta' aktar minn 1 gramma ta' ta' sorbitol jista' jaffettwa l-assorbiment ta' xi mediċini.
English: In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on placebo.
Maltese: Fi Studju 332, f'pazjenti b'aċċessjonijiet PGTC li kellhom ukoll aċċessjonijiet mijokloniċi fl-istess ħin, il-ħelsien mill-aċċessjonijiet intlaħaq f'16.7% (4/24) tal-pazjenti li kienu qed jieħdu perampanel meta mqabbel ma' 13.0% (3/23) ta' dawk li kienu fuq plaċebo.
English: DO7 PF53
Maltese: DO7 PF53 Ireland
English: du Plessis Beuscher 35220 Chateaubourg France
Maltese: Z.I. du Plessis Beuscher 35220 Chateaubourg
English: Laboratoire LCV Z.I.
Maltese: Laboratoire LCV
English: Date of first authorisation: 14/06/2011 Date of last renewal: 17/05/2016
Maltese: Data tal-aħħar tiġdid: 17/05/2016
English: Chickens from 5 weeks of age
Maltese: Tiġieġ minn 5 ġimgħat ta' età
English: Glenorie Manufacturing Facility Bioproperties Pty Ltd 11-13 Moores Rd, Glenorie, NSW, 2157 Australia
Maltese: 11-13 Moores Rd, Glenorie, NSW, 2157
English: Store frozen below -70°C for a maximum of 4 years.
Maltese: Aħżen fil-friża taħt -70°C għal perjodu massimu ta' 4 snin.
English: Such antibiotics include e.g. tetracycline, tiamulin, tylosin, quinolones, lincospectin, gentamicin or macrolide antibiotics.
Maltese: Antibijotiċi bħal dawn jinkludu eż. tetracycline, tiamulin, tylosin, quinolones, lincospectin, gentamicin jew antibijotiċi makrolidi.
English: One dose (30 µl) contains:
Maltese: Doża waħda (30 µl) fiha:
English: MS-H Vaccine eye drops suspension M. synoviae strain MS-H
Maltese: MS-H Vaccine sospensjoni tal-għajnejn M. synoviae strain MS-H
English: Pharmacotherapeutic group: immunologicals for Aves, live bacterial vaccines ATCvet code: QI01AE03
Maltese: Immunoloġiċi għat-tjur, vaċċini batterjali ħajjin Kodici ATĊ veterinarja : QI01AE03
English: • Thaw unopened bottles rapidly between 33-35°C for a time period of 10 minutes in a thermostatic water bath.
Maltese: • Dewweb malajr il-kontenut tal-flixkunli jkun għadu ma nfetaħx bejn 33- 35°C għal perjodu ta' 10 minuti f'banju termostatiku tal-ilma.
English: Use at room temperature (22-27°C) within 2 hours after thawing.
Maltese: Uża f'temperatura ambjentali (22-27°C) fi żmien sagħtejn wara li ddewweb.
English: The vaccine induces an active immunity against Mycoplasma synoviae in chickens.
Maltese: Il-vaċċin jinduċi immunità attiva kontra Mycoplasma synoviae fit-tiġieġ.
English: Plastic LDPE bottle of 30 ml (1,000 doses) with butyl rubber stopper sealed with an aluminium cap.
Maltese: Flixkun tal-LDPE tal-plastik ta' 30 ml (1000 doża) b'għatu tal-lastku tal-butyl u ssiġillat b'kappa talaluminju.
English: See also section 4.7
Maltese: Ara wkoll is-sezzjoni 4.7
English: One dose (30 µl) contains: Mycoplasma synoviae strain MS-H live attenuated thermosensitive, at least 105.7 CCU*
Maltese: Doża waħda (30 µl) fiha: Mycoplasma synoviae razza MS-H ħajja attenwata termosensittiva, tal-anqas 105.
English: • Infection with M. synoviae induces a transient positive antibody response to Mycoplasma gallisepticum.
Maltese: • Infezzjoni bi M. synoviae tinduċi rispons temporanju pożittiv għall-antikorpi għal Mycoplasma gallisepticum.
English: • Distinguishing between field strains and the vaccine strain of M. synoviae can be performed by Hammond classification or High Resolution Melt (HRM) testing by a laboratory.
Maltese: • Distinzjoni bejn ir-razza attwali u r-razza tal-vaċċin ta' M.synoviae tista' ssir permezz ta' ittestjar bil-klassifikazzjoni ta' Hammond jew High Resolution Melt (HRM) f'laboratorju.
English: Manufacturer responsible for batch release:
Maltese: Manifattur responsabbli għall-hruġ tal-lott:
English: Thaw the unopened bottle rapidly between 33-35°C for a time period of 10 minutes in a thermostatic water bath.
Maltese: Dewweb malajr il-flixkun li għadu ma nfetaħx bejn 33- 35°C għal perjodu ta' żmien ta' 10 minuti f'banju termostatiku tal-ilma.
English: The components of the excipient listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Il-komponenti tas-sustanzi mhux attivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-prodott fil-qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Onset of immunity: 4 weeks after vaccination.
Maltese: Bidu tal-immunità: 4 ġimgħat wara l-vaċċinazzjoni.
English: Infection with M. synoviae induces a transient positive antibody response to Mycoplasma gallisepticum.
Maltese: Infezzjoni bi M. synoviae tinduċi rispons temporanju pożittiv għall-antikorpi għal Mycoplasma gallisepticum.
English: Distinguishing between field strains and the vaccine strain of M. synoviae can be performed by Hammond classification or High Resolution Melt (HRM) testing by a laboratory.
Maltese: Id-distinzjoni bejn ir-razez attwali u r-razza tal-vaċċin ta' M. synoviae tista' ssir permezz ta' ittestjar bil-klassifikazzjoni Hammond jew High Resolution Melt (HRM) f'laboratorju.
English: Chickens
Maltese: L-ISEM
English: Other ingredients:
Maltese: NOTA:
English: Ocular use
Maltese: IL-PROVVISTA
English: MAH Number: EU/2/11/126/001 To be supplied only on veterinary prescription.
Maltese: Numru tal-MAH: EU/2/11/126/001
English: Detailed information on this 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: Do not use after the expiry date which is stated on the label.
Maltese: Tużax wara d-data ta' skadenza li hemm fuq it-tabella.
English: Vaccine should not be stored back in -70°C after storage at or below -18°C.
Maltese: Il-vaċċin ma għandux jerġa' jinħażen f'temperatura ta' -70°C wara l-ħażna jew taħt -18°C.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: Batch{number}
Maltese: PERJODU TA' TIŻMIM
English: Zero days.
Maltese: Tiġieġ.
English: * colour changing units For the full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' sustanzi mhux attivi, ara s-sezzjoni 6.1.
English: Use calibrated dropper or device, so as to distribute 30 µl drop of vaccine.
Maltese: Uża qattara jew apparat ikkalibrat, sabiex titfa' qatra ta' 30 µl tal-vaċċin.
English: Modified Frey's medium containing phenol red and swine serum.
Maltese: Mezz Immodifikat ta' Frey li fih phenol aħmar u s-serum tal-majjali.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LDPE BOTTLE 30 ml LABEL
Maltese: TIKKETTA TA' FLIEXKEN LDPE TA' 30 ml
English: Ocular use.
Maltese: Użu okulari
English: Chickens should be vaccinated once by applying one eye drop (30 µl) from 5 weeks of age and at least 5 weeks before the onset of the laying period.
Maltese: It-tiġieġ għandhom jiġu vvaċċinati darba billi jiġi applikat permezz ta' qatra waħda fl-għajn (30 µl) minn 5 ġimgħat ta' età u għallanqas 5 ġimgħat qabel ma jibda l-perjodu li fih jbidu.
English: Testing for the presence of M. synoviae in the flock is normally by way of the rapid serum agglutination test (RSAT) with blood samples being tested within 24 hours of collection.
Maltese: L-ittestjar għall-preżenza ta' M. synoviae fil-qatgħa ġeneralment isir permezz ta' test ta' agglutinazzjoni tas-serum rapida (RSAT) u l-kampjuni tad-demm jiġu ttestjati fi żmien 24 siegħa minn meta jinġabru.
English: For vaccination of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.
Maltese: 6.6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti tal-pajjiż.
English: Where antibiotics must be used, preference should be given to agents with no anti-mycoplasma activity, such as penicillin, amoxicillin or neomycin.
Maltese: Fejn ikun hemm bżonn li jintużaw l-antibijotiċi, għandha tingħata preferenza lill-aġenti b'attività antimikoplażma, bħal peniċillina, amoxicillin jew neomycin.
English: • Only flocks with no antibodies to MS (M. synoviae) should be vaccinated.
Maltese: • Għandhom jiġu vvaċċinati biss il-qatgħat li ma għadhom l-ebda antikorp għal MS (M.synoviae).
English: MS-H Vaccine eye drops suspension
Maltese: MS-H Vaccine sospensjoni tal-qtar tal-għajnejn
English: • The vaccine strain can be detected in respiratory tract of the chickens until 55 weeks after vaccination.
Maltese: • Ir-razza tal-vaċċin tista' tiġi individwata fl-apparat respiratorju tat-tiġieġ sa 55 ġimgħa wara l-vaċċinazzjoni.
English: If necessary, further differentiation of the 2 Mycoplasma species can be done by using PCR in a laboratory.
Maltese: Jekk meħtieġ, tista' ssir differenzazzjoni ulterjuri taż-żewġ speċi ta' Mycoplasma permezz ta' PCR f'laboratorju.
English: Mycoplasma synoviae strain MS-H live attenuated thermosensitive, at least 105.7 CCU* *colour changing units
Maltese: Razza MS-H ħajja attenwata termosensittiva, ta' Mycoplasma synoviae tal-inqas 105.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Maltese: DATA TA' SKADENZA Jiskadi {xahar / sena}
English: Modified Frey's medium containing phenol red and swine serum
Maltese: Ingredjenti oħra: Medju Immodifikat ta' Frey li fih phenol aħmar u s-serum tal-majjali
English: Red orange to straw translucent suspension.
Maltese: Ipproteġi mix-xemx diretta.
English: For active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.
Maltese: Għall-immunizzazzjoni attiva ta' tiġieġ li sejrin jitrabbew għall-bajd, tiġieġ li sejrin jitrabbew għallaħam (brojlers) u tiġieġ li sejrin jitkabbru għall-bajd minn età ta' ħames ġimgħat biex jitnaqqsu lleżjonijiet fil-borża tal-arja u jitnaqqsu n-numru ta' bajd b'formazzjonijiet abnormali tal-qoxra kkawżati bi Mycoplasma synoviae.
English: Although no data are available on the matter, it is likely that vaccination with this product will also induce a positive antibody response to Mycoplasma gallisepticum and may therefore interfere with the serological monitoring of Mycoplasma gallisepticum.
Maltese: Għalkemm ma hemm l-ebda dejta disponibbli dwar il-kwistjoni, huwa probabbli li lvaċċinazzjoni b'dan il-prodott tinduċi wkoll rispons pożittiv għal antikorpi għal Mycoplasma gallisepticum u għalhekk tista' tfixkel il-monitoraġġ seroloġiku ta' Mycoplasma gallisepticum.
English: Vaccination should be carried out on M. synoviae -free birds at least 4 weeks before expected exposure to virulent M. synoviae.
Maltese: It-tiġieġ ta' inqas minn sena għandhom l-ewwel jiġu ttestjati għal infezzjoni bi M. synoviae.
English: ADVICE ON CORRECT ADMINISTRATION Chickens from 5 weeks of age
Maltese: U METODU TA' AMMINISTRAZZJONI Użu okulari.
English: NOTE: There is no outer carton
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Invert the dropper bottle or prepare the device allowing a single drop to form at the tip and fall freely into the open eye, gently flooding it.
Maltese: Aqleb il-flixkun bil-qattara jew lesti l-apparat billi tħalli qatra waħda tifforma fit-tarf u taqa' liberament ġewwa l-għajn miftuħa, u tgħerriqha bil-mod. Il-qatra (qabel ma tiġi rilaxxata) u l-ponta ma għandhomx imissu s-superfiċje tal-għajn.
English: EMA/532705/2010 EMEA/V/C/002002
Maltese: EMA/532705/2010
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Certifect on 6 May 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Certifect fis-6 ta' Mejju 2011.