FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: 1/10 x 2,500, 5,000, 10,000, 20,000 doses
Maltese: KUNJETT TAL-ĦĠIEĠ 1/10 x 2,500, 5,000, 10,000, 20,000 doża
English: Withdrawal period: 0 days.
Maltese: Żmien ta' tiżmim: 0 ġranet.
English: Camprodón s/n "la Riba"
Maltese: FULJETT TA' TAGĦRIF
English: Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc. and antibiotics.
Maltese: Kun żgur li l-pajpijiet kollha, tubi, ħwat, apparat tax-xorb, eċċ. huma mnaddfa sew u ħielsa minn traċċi ta' diżinfettanti, deterġenti, sapun, eċċ u antibijotiċi.
English: Vaccinated birds may excrete the vaccine strain by faecal route for up to 5 weeks (chickens) or 7 days (turkeys) post vaccination and the vaccine may remain present in the environment until the end of the finishing or rearing period (chickens) or for 7 days (turkeys).
Maltese: Tjur imlaqqma jistgħu jeliminaw ir-razza tal-vaċċin permezz tal-ippurgar sa 5 ġimgħat (tiġieġ) jew 7 ijiem (dundjani) mill-għoti tat-tilqima, u t-tilqima tista' tibqa' preżenti fl-ambjent sa tmiem is-simna jew it-trobbija(tiġieġ) jew għal 7 ijiem (dundjani).
English: Use clean vaccination materials and turn off ventilation until 15 minutes after vaccination.
Maltese: Uża materjali ta' vaċċinazzjoni li huma ndaf u itfi l-ventilazzjoni sa 15-il minuta wara l-vaċċinazzjoni.
English: Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray).
Maltese: 8 ġimgħat għat-tnaqqis ta' ġrieħi u 12-il ġimgħa għat-tnaqqis ta' mortalità (bexx). 12-il ġimgħa għat-tnaqqis ta' ġrieħi u mortalità (ilma tax-xorb).
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 bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqax fl ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: Low-fat skimmed milk powder (i.e. < 1% fat) may be added to the water (2-4 grams per litre) or skimmed milk (20-40 ml per litre of water) to improve the water quality and to increase the stability of the bacteria.
Maltese: Trab tal-ħalib xkumat baxx fix-xaħam (i.e. <1-% xaħam) jista' jingħata mal-ilma (2-4 g ma' litru) jew ħalib xkumat (20-40 ml ma' litru) biex itejjeb il-kwalità tal-ilma u jżid l-istabilità tal-batterji.
English: The vaccine strain can be detected in tissues (liver, heart) until 6 days (chickens) or in tissues (thoracic air sacs) 4 days (turkeys) post vaccination.
Maltese: Ir-razza tal-vaċċin tista' tiġi misjuba fit-tessuti (fwied, qalb) sa 6 ijiem (tiġieġ) jew fit-tessuti (boroż toraċiċi tal-arja) 4 ijiem (dundjani) wara t-tilqima.
English: The vaccine is supplied in type I borosilicate glass vial of 10 ml or 50 ml with a bromobutyl rubber stopper sealed with aluminium crimp caps.
Maltese: Dan il-vaċċin jiġi f'kunjett tal-ħġieġ tal-borosilicate tip I ta' 10 ml jew 50 ml b'tapp tal-lastiku talbromobutyl issiġġilat b'għotjien tal-aluminju.
English: Upon reconstitution, transparent to white-yellowish and opaque suspension (depending on the volume of diluent used).
Maltese: Mar-rikostituzzjoni, suspensjoni trasparenti li tagħti fl-abjad-safrani u opaka (skont il-volum tad-dilwent użat).
English: Ctra.
Maltese: IEĦOR
English: Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
Maltese: KONTRAINDIKAZZJONIJIET M'għandekx tlaqqam annimali li jkunu qed jieħdu trattament antibatteriku jew immunosoppressiv.
English: 5.2 x 106 - 9.1 x 108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Maltese: tip O78, razza EC34195 * Unitajiet li jifformaw kolonja (Colony forming units) meta mkabbra fuq trypticase soy agar plates Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of one vial of 2,500 or 5,000 or 10,000 or 20,000 doses Cardboard box of ten vials of 2,500 or 5,000 or 10,000 or 20,000 doses
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 2,500, 5,000, 10,000, 20,000 doża Kaxxa tal-kartun b'għaxar kunjetti ta' 2,500, 5,000, 10,000, 20,000 doża
English: In drinking water use:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Chickens and turkeys
Maltese: EFFETTI MHUX MIXTIEQA
English: Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
Maltese: VETERINARJU Poulvac E. coli lijofilizzat għal suspensjoni għal vaċċinazzjoni b'bexx jew għall-użu mal-ilma tax-xorb.
English: Other precautions:
Maltese: Prekawzjonijiet oħra:
English: No adverse reactions have been observed after the administration of a 10 fold overdose of the vaccine.
Maltese: L-ebda reazzjonijiet avversi ma ġew osservati wara l-amministrazzjoni ta' doża eċċessiva ta' 10 darbiet tal-vaċċin.
English: Immunisation has to be considered as one component in a complex control program that addresses all important hygienic and health factors for poultry.
Maltese: L-immunizzazzjoni għandha tiġi kkunsidrata bħala komponent wieħed fi programm kumpless ta' kontroll li jindirizza l-iġjene u fatturi importanti ta' saħħa għat-tjur.
English: Spray vaccination or in drinking water use.
Maltese: U/JEW UŻU Mhux applikabbli.
English: The vaccine strain can be identified by its growth properties on biological growth media: it shows normal growth on MacConkey and trypticase soy agar, while no colonies are observed when plated without aromatic amino acids (minimum agar).
Maltese: Ir-razza tal-vaċċin tista' tiġi identifikata skont ilkaratteristiċi tal-iżvilupp tagħha fuq il-midja tal-iżvilupp bijoloġiku: turi żvilupp normali fuq ilMacConkey u trypticase soy agar, filwaqt li l-ebda kolonja ma hi osservata meta ġiet ipplejtjata mingħajr aminoaċidi aromatiċi (bl-inqas agar).
English: The recommended volume for 1 dose is between 0.1 and 0.5 ml.
Maltese: Il-volum rakkomandat għal doża waħda huwa ta' bejn 0.1 u 0.5 ml.
English: The spraying distance should be between 30 and 80 cm above the animals in order to ensure an even distribution and the recommended droplet size is greater than 100 µm.
Maltese: Id-distanza għall-bexx għandha tkun bejn 30 u 80 ċm minn mal-annimali sabiex tiġi żgurata firxa kostanti u d-daqs tal-qtar rakkomandat huwa t'akbar minn 100 µm.
English: Ideally, vaccine should be administered in the volume of water consumed by the birds in up to 3 hours.
Maltese: Idealment il-vaċċin għandu jingħata f'volum ta' ilma li jiġi kkunsmat mit-tjur fi żmien 3 sigħat.
English: The onset of immunity has not been established for the mortality claim.
Maltese: Il-bidu tal-immunità ma ġiex stabbilit għallpreżunzjoni tal-mortalità.
English: Pharmacotherapeutic group: Immunologicals for aves, live bacterial vaccines for domestic fowl.
Maltese: Immunoloġiċi għat-tjur, vaċċini batterjali ħajjin - għal tajr domestiku.
English: EU/1/16/1104/001
Maltese: EU/1/16/1104/001 Palonosetron Accord
English: Intravenous use vial (glass) 5 ml
Maltese: Użu għal ġol-vini kunjett (ħġieġ) 5 ml
English: (Invented) name Strength Pharmaceutical form
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Palonosetron Accord 250 microgra ms
Maltese: 250 mikro gramma
English: Solution for injection
Maltese: Soluzzjoni għal injezzjoni
English: EU/1/19/1367/001 Zynteglo cells/mL
Maltese: EU/1/19/1367/001 Zynteglo ċelluli/mL
English: Intravenous use bag (FEP)
Maltese: Borża (FEP)
English: Dispersion for infusion
Maltese: dispersjoni għall-infużjoni
English: Section 3
Maltese: Sezzjoni 3
English: Section 1
Maltese: Sezzjoni 1
English: Section 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).
Maltese: Kura adjuvant fi prevenzjoni sekondarja wara infart mijokardijaku, flimkien ma' terapija standard oħra (eż. statini, prodotti mediċinali kontra l-pjastrini, imblokkaturi tar-riċetturi Beta, inibituri tal-ACE).
English: Section 4.1: Therapeutic indications
Maltese: Sezzjoni 4.1: Indikazzjonijiet terapewtiċi
English: One capsule daily.
Maltese: Kapsula waħda kuljum.
English: Section 4.2: Posology and method of administration Information related to “secondary prevention after myocardial infarction” indication should be deleted: Post Myocardial Infarction
Maltese: Sezzjoni 4.2: Pożoloġija u metodu ta' kif għandu jingħata Informazzjoni relatata mal-indikazzjoni “prevenzjoni sekondarja wara infart mijokardijaku” għandha titħassar.
English: The usual dose is one capsule a day.
Maltese: Id-doża normali hija ta' kapsula waħda kuljum.
English: Annex III Amendments to relevant sections of the Product Information
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tal-Informazzjoni dwar il-Prodott
English: Post Myocardial Infarction
Maltese: Sommarju tal-Karatteristiċi tal-Prodott
English: Existing relevant text in section 5.1 of the SmPC in relation to “secondary prevention after myocardial infarction” indication should be deleted.
Maltese: It-test rilevanti eżistenti fit-taqsima 5.1 tal-SmPC fir-rigward tal-indikazzjoni “prevenzjoni sekondarja wara infart mijokardijaku” għandu jitħassar.
English: For omega-3 containing medicinal products, the existing product information shall be amended (deletion of the text as appropriate) as provided below:
Maltese: Għall-prodotti mediċinali li fihom omega-3, l-informazzjoni eżistenti dwar il-prodotti għandha tiġi emendata (tħassir tat-test kif xieraq) kif previst hawn taħt:
English: The absolute bioavailability was 74%.
Maltese: Il-bijodisponibilità assoluta kienet ta' 74%.
English: ATC vet code: QP53BE01.
Maltese: Kodici veterinarja ATC: QP53BE01.
English: 1 tablet 3 tablets 6 tablets 15 tablets
Maltese: 3 pilloli 6 pilloli 15 il -pillola
English: Macrogol 15 hydroxystearate Glycerol (E422) Medium-chain triglycerides
Maltese: Macrogol 15 hydroxystearate Glycerol (E422) Triglycerides medium-chain
English: 4 Chemin du Calquet 31000 Toulouse FRANCE
Maltese: 4 Chemin du Calquet, 31000 Toulouse,
English: Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
Maltese: Lamtu tal-qamħirrun Soy protein fines Beef braised flavouring Povidone (E1201) Macrogol 400
English: Date of first authorisation: 20/05/2019
Maltese: Data tal-ewwel awtorizzazzjoni: 20/05/2019
English: Treatment of demodicosis (caused by Demodex canis):
Maltese: Kura ta' demodikosi (ikkawżata minn Demodex canis);
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Maltese: Kura ta' sarcoptic mange (ikkawżata minn Sarcoptes scabiei var.canis).
English: {DD/MM/YYYY}
Maltese: U/JEW UŻU
English: The mean maximum concentration (Cmax) was 1,655 ± 332 ng/ml in plasma at 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Maltese: Il-konċentrazzjoni massima medja (Cmax) kienet 1,655 ± 332 ng/ml fi plasma 2 - 4 sigħat (Tmax) wara doża ta' afoxolaner ta' 2.5 mg/kg.
English: In-vitro experiments demonstrated that P-glycoprotein efflux does not occur, confirming that afoxolaner is not a substrate for the P-glycoprotein transporters.
Maltese: Esperimenti in-vitro wrew li l-P-glycoprotein ma toħroġx, li jikkonferma li l-afoxolaner mhux sottostrat għat-trasportaturi tal-P-glycoprotein.
English: Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg.
Maltese: Afoxolaner jiġi distribwit fit-tessuti b'volum ta' distribuzzjoni ta' 2.6 ± 0.6 l/kg u valur ta' tneħħija sistemika ta' 5.0 ± 1.2 ml/siegħa/kg.
English: EU/2/19/240/015 EU/2/19/240/016
Maltese: EU/2/19/240/016
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Maltese: Klieb 2− 4 kg Klieb >4−10 kg Klieb >10−25 kg Klieb >25−50 kg
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Maltese: Kura ta' infestazzjonijiet b'qurdien fil-klieb (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
English: Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Maltese: Afoxolaner huwa insettiċida u akariċida li jappartjeni għal-familja ta' isoxazoline.
English: Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated.
Maltese: Afoxolaner fil-kelb jiġi metabolizzat f'komposti idrofiliċi mbagħad eliminat.
English: EU/2/19/240/001 EU/2/19/240/002 EU/2/19/240/003 EU/2/19/240/004 EU/2/19/240/005 EU/2/19/240/006 EU/2/19/240/007 EU/2/19/240/008 EU/2/19/240/009 EU/2/19/240/010 EU/2/19/240/011 EU/2/19/240/012 EU/2/19/240/013 EU/2/19/240/014
Maltese: EU/2/19/240/001 EU/2/19/240/002 EU/2/19/240/003 EU/2/19/240/004
English: Afoxolaner MERIAL is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Maltese: Afoxolaner huwa attiv kontra l-briegħed adulti kif ukoll speċi differenti ta' qurdien bħal Dermacentor reticulatus u D. variabilis, Ixodes ricinus,u I. Scapularis, Rhipicephalus sanguineus, Amblyomma americanum, u Haemaphysalis longicornis.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Ewropea dwar il-Mediċini (http://www.ema.europa.eu).
English: common (more than 1 but less than 10 animals in 100 animals treated) uncommon (more than 1 but less than 10 animals in 1,000 animals treated) rare (more than 1 but less than 10 animals in 10,000 animals treated) very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Maltese: Dermacentor reticulatus u D. variabilis, Ixodes ricinus, u I. Scapularis, Rhipicephalus sanguineus, Amblyomma americanum, u Haemaphysalis longicornis.
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Maltese: Ektoparasittiċidi għal użu sistemiku.
English: The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines' GABA receptors versus mammalian receptors.
Maltese: It-tossiċità selettiva tal-Afoxolaner bejn insetti/akari u mammiferi tista' tiġi dedotta mis-sensittività differenzjali tar-riċetturi GABA tal-insetti/akari meta mqabbla mar-riċetturi tal-mammiferi.
English: The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu).
Maltese: Il-prodott veterinarju mediċinali huwa ppakkjat individwalment fi blisters tal-PVC illaminat iffurmati bis-sħana miksija minn wara b'folja tal-aluminju (Aclar/PVC/Alu).
English: None known.
Maltese: ġimgħat.
English: The frequency of adverse reactions is defined using the following convention:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: Each chewable tablet contains: Afoxolaner MERIAL
Maltese: Kull pillola li tintmagħad fiha: Afoxolaner MERIAL c/
English: Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Maltese: Effetti gastrointestinali ħfief (rimettar, dijarea), ħakk, ħedla, anoressja u sinjali newroloġiċi (konvulżjonijiet, atassja, u rogħda muskolari) ġew irrapportati f'każi rari ħafna.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju/riskju mill-veterinarju responsabbli.
English: Chewable tablets.
Maltese: Pilloli li jintmagħdu.
English: Manufacturer responsible for batch release: MERIAL
Maltese: Manifattur responsabbli għal-ħrug tal-lott: MERIAL,
English: To be supplied only on veterinary prescription.
Maltese: Rekwiżiti speċifiċi ta' farmakoviġilanza.
English: Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Maltese: Afoxolaner MERIAL 11 mg klieb 2 - 4 kg Afoxolaner MERIAL28 mg klieb >4 - 10 kg Afoxolaner MERIAL 68 mg klieb >10 - 25 kg Afoxolaner MERIAL136 mg klieb >25 - 50 kg afoxolaner
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Il-prodott jista' jintuża bħala parti minn strateġija ta' kura għal-kontroll ta' dermatite ta' allerġija għal-briegħed (FAD).
English: The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals treated displaying adverse reaction(s)).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru reazzjoni(jiet) mhux mixtieqa
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Maltese: Pilloli ħomor sa kannella fl-aħmar bid-dbabar, b'forma tonda (pilloli għal klieb 2-4 kg) jew b'forma rettangolari pilloli għal klieb >4-10 kg, pilloli għal klieb >10-25 kg u pilloli għal klieb >25-50 kg).
English: The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Maltese: Il-metaboliti u l-kompost ewlieni jiġu eliminati mill-ġisem bi tneħħija fl-awrina u mill-marrara bil-maġġor parti eliminat filbili.
English: Bodyweight of dog (kg)
Maltese: Piż tal-ġisem tal kelb (kg)
English: Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Maltese: Afoxolaner jaġixxi fil-kanali ta' ligand-gated chloride, b'mod partikulari dawk gated min-newrotrażmettitur gammaaminobutyric acid (GABA) b'hekk jiġi mblukkat it-trasferiment tal-joni tal-kloridu tul il-membrani taċ-ċelluli qabel u wara t-trasferiment sinattiku.
English: Each chewable tablet contains:
Maltese: Kull pillola li tintmagħad fiha:
English: For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Maltese: Għal kull qawwa, il-pilloli li jintmagħdu jinstabu fid-daqsijiet tal-pakkett li ġejjin: kaxxa bi blister li fiha 1, 3 jew 6 pilloli li jintmagħdu jew 15-il blister ta' pillola li jintmagħdu f'kull waħda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton
Maltese: KUNDIZZJONIJIET OĦRA U REKWŻITI
English: Treatment of flea and tick infestations:
Maltese: Prekawzjonijiet speċjali għal-użu fl-annimali:
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females.
Maltese: Testijiet fil-laboratorju fuq ġrieden u fniek ma wrewx evidenza ta' effetti teratoġeniċi, jew xi effetti oħra mhux mixtieqa fuq il-kapaċità riproduttiva ta' klieb irġiel u nisa.
English: After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration.
Maltese: Wara li ġie amministrat lill-klieb mill-ħalq, ġie muri li Afoxolaner kellu assorbiment sistemiku għoli wara l-amministrazzjoni.
English: Afoxolaner MERIAL kills fleas within 8 hours and ticks within 48h.
Maltese: Afoxolaner MERIAL joqtol il-briegħed fi żmien 8 sigħat u l-qurdien fi żmien 48 siegħa.
English: For oral use
Maltese: MANIFATTUR RESPONSABBLI
English: Return the blister with the remaining chewable tablets into the carton.
Maltese: Daħħal lura l-blister mal-kumplament tal-pilloli li jintwagħdu fil-kaxxa.
English: Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks.
Maltese: Kura ta' infestazzjonijiet bi briegħed fil-klieb (Ctenocephalides felis u C. canis) għal mill-inqas 5 ġimgħat.
English: Pregnancy and lactation:
Maltese: ANNESS I KARATTERISTIĊI
English: Maize starch
Maltese: PARIR SABIEX
English: This results in uncontrolled activity of the central nervous system and death of insects or acarines.
Maltese: Dan jirriżulta f'attività mhux ikkontrollata tas-sistema nervuża ċentrali u l-mewt ta' insetti u akari.
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs (2-4 kg) Afoxolaner MERIAL 28 mg chewable tablets for dogs (>4-10 kg) Afoxolaner MERIAL 68 mg chewable tablets for dogs (>10-25 kg) Afoxolaner MERIAL 136 mg chewable tablets for dogs (>25-50 kg) afoxolaner
Maltese: Afoxolaner MERIAL11 mg pilloli li jintmagħdu għal klieb (2−4 kg) Afoxolaner MERIAL28 mg pilloli li jintmagħdu għal klieb (> 4−10 kg) Afoxolaner MERIAL 68 mg pilloli li jintmagħdu għal klieb (> 10−25 kg) Afoxolaner MERIAL136 mg pilloli li jintmagħdu għal klieb (> 25−50 kg)
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Maltese: Afoxolaner MERIAL11 mg pilloli li jintmagħdu għal klieb 2−4 kg Afoxolaner MERIAL 28 mg pilloli li jintmagħdu għal klieb > 4−10 kg Afoxolaner MERIAL 68 mg pilloli li jintmagħdu għal klieb > 10−25 kg Afoxolaner MERIAL136 mg pilloli li jintmagħdu għal klieb > 25−50 kg
English: 15 November 2012
Maltese: 15 ta' Novembru 2012
English: EMEA/H/C/product number
Maltese: EMEA/H/C/numru tal-prodott
English: What is Istodax?
Maltese: X'inhu Istodax?
English: The company that applied for authorisation is Celgene Europe Ltd.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Celgene Europe Ltd.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Istodax is a medicine that contains the active substance romidepsin.
Maltese: Istodax huwa mediċina li fiha s-sustanza attiva romidepsin.
English: Refusal of the marketing authorisation for Istodax (romidepsin)
Maltese: Istodax (romidepsin)