FrancophonIA/ELRC3.0 huggingface dataset:
English: Matever tablets are swallowed with liquid.
Maltese: Pilloli Matever jinbelgħu mal-likwidu.
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: L-epilessija tiġi kkawżata mill-attività elettrika eċċessiva fil-moħħ.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Keppra, il-benefiċċju huwa akbar mir-riskju identifikat.
English: What are the benefits and risks of Matever?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Matever?
English: When Matever is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Meta Matever jintuża waħdu, id-doża tal-bidu hija 250 mg darbtejn kuljum, u tiżdied ġimagħtejn wara għal 500 mg darbtejn kuljum.
English: Matever can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Maltese: Matever jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għall-ewwel darba blepilessija, sabiex ifejjaq il-bidu parzjali ta' aċċessjoni (epilessija severa) bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: The daily dose can be increased up to 1500 mg twice a day.
Maltese: Id-doża ta' kuljum tista' titla' sa mhux aktar minn 1,500 mg darbtejn kuljum.
English: Other information about Matever
Maltese: Kif jintuża Matever?
English: Other information about Netvax:
Maltese: Informazzjoni oħra dwar Netvax:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NETVAX EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) NETVAX Sommarju tal-EPAR għall-pubbliku
English: Netvax is a vaccine.
Maltese: Netvax huwa vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B.V. on 16 April 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-UE għal Netvax lil Intervet International B.V. fil-16 ta' April 2009.
English: Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.
Maltese: In-nefħa wara l-ewwel tilqima normalment titlaq fi żmien 30 jum, u tista' ddum mill-inqas 35 jum wara t-tieni tilqima.
English: What is Netvax?
Maltese: X'inhu Netvax?
English: Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid.
Maltese: Netvax fih tip wieħed tat-tossojde minn C. perfringens imsejjaħ it-tossojde alfa.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Netvax exceed the risks for the active immunisation of chickens, to provide passive immunisation against necrotic enteritis to their progeny, during the laying period, to reduce mortality and the incidence and severity of lesions caused by C. perfringens type A-induced necrotic enteritis.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Netvax huma akbar mir-riskji għat-tilqim attiv tat-tiġieġ, għall-għoti ta' immunità passiva kontra lenterite nekrotika lill-wild tagħhom, waqt il-perijodu li fih ikunu qed ibidu, għat-tnaqqis tal-mortalità u tal-inċidenza u s-severità tal-leżjonijiet ikkawżati minn enterite nekrotika kkaġunata minn C. perfringens tat-tip A.
English: The withdrawal period is zero days.
Maltese: Il-perijodu ta' tiżmim huwa xejn.
English: Netvax is a vaccine that contains a toxoid (a weakened toxin) from the bacterium Clostridium perfringens (C. perfringens) type A. The vaccine is an emulsion (a mixture of oil- and water-based liquids) for injection.
Maltese: Netvax huwa vaċċin li fih tossojde (tossina mdgħajfa) mill-batterju Clostridium perfringens (C. perfringens) tat-tip A.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet talCVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: How has Netvax been studied?
Maltese: Kif ġie studjat Netvax?
English: Why has Netvax been approved?
Maltese: Għaliex ġie approvat Netvax?
English: What benefit has Netvax shown during the studies?
Maltese: Liema benefiċċju wera Netvax waqt l-istudji mwettqa?
English: The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens' blood and in their eggs.
Maltese: Il-miżura ewlenija tal-effikaċja kienet il-produzzjoni ta' antikorpi protettivi kontra C. perfringens tat-tip A fid-demm tat-tiġieġ u fil-bajd tagħhom.
English: What is the risk associated with Netvax?
Maltese: X'inhu r-riskju assoċjat ma' Netvax?
English: Netvax is used to vaccinate chickens against necrotic enteritis caused by C. perfringens type A, so that they pass their immunity against the disease on to their chicks.
Maltese: Netvax jintuża għat-tilqim tat-tiġieġ kontra enterite nekrotika kkawżata minn C. perfringens tat-tip A, sabiex dawn jgħaddu l-immunità tagħhom kontra din il-marda lill-flieles tagħhom.
English: These antibodies help the chicks to fight necrotic enteritis caused by C. perfringens type A if they are exposed to the bacterium after they have hatched.
Maltese: L-antikorpi jgħinu lill-flieles jiġġieldu l-enterite nekrotika kkawżata minn C. perfringens tattip A jekk ikunu esposti għall-batterju wara li jkunu faqqsu.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni dwar l-istejtus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/il-pakkett ta' barra.
English: In chicks hatched from vaccinated hens, the vaccine reduced the number of deaths, and the incidence and the severity of lesions caused by necrotic enteritis.
Maltese: Fil-flieles li faqqsu minn tiġieġ imlaqqma, il-vaċċin naqqas l-għadd ta' mwiet, u l-inċidenza u sseverità tal-leżjonijiet ikkawżati minn enterite nekrotika.
English: The vaccine also contains an ‘adjuvant' (mineral oil) to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvant' (żejt minerali) sabiex jistimula rispons aħjar.
English: If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor.
Maltese: L-effikaċja ta' Netvax ġiet studjata f'bosta provi taħt kundizzjonijiet tal-laboratorju u fil-prattika fittiġieġ u l-flieles tagħhom.
English: The studies also looked at death rates in the chicks hatched by vaccinated hens, and at the incidence and the severity of lesions caused by necrotic enteritis in the gut after the chicks were deliberately infected with the bacterium at three weeks of age.
Maltese: L-istudji ħarsu wkoll lejn ir-rati ta' mwiet filflieles imfaqqsa minn tiġieġ imlaqqma, u lejn l-inċidenza u s-severità tal-leżjonijiet ikkawżati minn enterite nekrotika fl-intestin wara li l-flieles ikunu ġew infettati intenzjonalment bil-batterju meta dawn kellhom tliet ġimgħat.
English: The vaccination schedule consists of two doses: the first dose is given at 10 to 14 weeks of age, and then a second dose is given four to 10 weeks after the first.
Maltese: Jekk l-uġigħ jibqa' jinħass għal aktar minn 12-il siegħa wara l-viżta, erġa' ħu parir mediku.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubblika Ewropew ta' Valutazzjoni (EPAR).
English: How does Netvax work?
Maltese: Kif jaħdem Netvax?
English: EMA/204830/2013 EMEA/H/C/002601
Maltese: EMEA/H/C/002601
English: The full EPAR for Tecfidera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Tecfidera
Maltese: Informazzjoni oħra dwar Tecfidera
English: Tecfidera is available as oral capsules (120 and 240 mg) to be taken with food.
Maltese: Tecfidera jiġi bħala kapsuli orali (120 u 240 mg) li għandhom jittieħdu mal-ikel.
English: Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Maltese: Tecfidera huwa mediċina li fiha s-sustanza attiva dimethyl fumarate.
English: In a second main study involving 1,417 patients, patients were given Tecfidera, placebo or another medicine, glatiramer acetate.
Maltese: F'tieni studu prinċipali li involva lil 1,417-il pazjent, pazjenti ngħataw Tecfidera, plaċebo jew mediċina oħra, glatiramer acetate.
English: This is a summary of the European public assessment report (EPAR) for Tecfidera.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tecfidera.
English: Tecfidera dimethyl fumarate
Maltese: Sommarju tal-EPAR għall-pubbliku dimethyl fumarate
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tecfidera on 30 January 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tecfidera fit-30 ta' Jannar 2014.
English: The number of relapses per patient per year for glatiramer acetate was 0.3.
Maltese: In-numru ta' rikaduti għal kull pazjenti fissena għal glatiramer acetate kien ta' 0.3.
English: This summary was last updated in 01-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 01-2014.
English: In a main study involving 1,234 patients, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.
Maltese: Fi studju prinċipali li involva lil 1,234 pazjent, il-proporzjon ta' pazjenti li esperjenzaw rikaduta fuq medda ta' sentejn kien ferm iktar baxx b'kura b'Tecfidera milli bi plaċebo (kura finta): 27% meta mqabbel ma' 46%.
English: Dimethyl fumarate, has been shown in studies to reduce the inflammation and modulate the activity of the immune system.
Maltese: Dimethyl fumarate, intwera fi studji li jnaqqas l-infjammazzjoni u jimmodula l-attivita tas-sistema immuni.
English: Why is Tecfidera approved?
Maltese: Għaliex ġie approvat Tecfidera?
English: What are the risks associated with Tecfidera?
Maltese: X'inhuma r-riskji assoċjati ma' Tecfidera?
English: The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal problems.
Maltese: Id-doża tista' titnaqqas temporanjament f'pazjenti li jesperjenzaw effetti sekondarji ta' fwawar u problemi gastrointestinali.
English: A risk management plan has been developed to ensure that Tecfidera is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Tecfidera jintuża bl-aktar mod sigur possibbli.
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Maltese: Fl-MS, is-sistema immuni tal-ġisem ma taħdimx tajjeb u tattakka partijiet tas-sistema nervuża ċentrali (il-moħħ u l-korda spinali), u dan jikkawża infjammazzjoni u ħsara lir-riti tan-nervituri.
English: The active substance, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2' that regulates certain ‘antioxidant' genes involved in protecting cells from damage.
Maltese: Is-sustanza attiva, dimethyl fumarate, hija maħsuba li taħdem billi tattiva proteina msejħa 'Nrf2' li tirregola lil ċerti ġeni 'antiossidanti' involuti fil-protezzjoni taċ-ċelloli minn ħsara.
English: The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area).
Maltese: L-aktar effetti sekondarji komuni b'Tecfidera (li jistgħu jaffettwaw lil aktar minn persuna 1 minn kull 10) huma fwawar (ħmura tal-ġilda) u problemi gastrointestinali (bħal dijarrea, dardir, u uġigħ fiż-żona addominali).
English: The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells and protein in the urine.
Maltese: Ir-riskji ewlenin identifikati b'Tecfidera huma meqjusin li huma maniġġevoli u jinkludu fwawar u problemi gastrointestinali (l-aktar effetti sekondarji komuni), kif ukoll livelli mnaqqsa ta' ċelloli tad-demm bojod u proteini fl-awrina.
English: The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.
Maltese: Id-doża hija ta' 120 mg darbtejn kuljum għall-ewwel sebat ijiem, u wara dan il-perjodu, din tiżdied għal 240 mg darbtejn kuljum.
English: It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Maltese: Jintuża biex jikkura l-isklerożi multipla (SM), marda li fiha, infjammazzjoni teqred ir-rita protettiva madwar in-nervituri.
English: This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo.
Maltese: Dan l-istudju wera li Tecfidera kien aktar effettiv minn plaċebo biex inaqqas lammont ta' rikaduti fuq medda ta' sentejn: in-numru ta' rikaduti għal kull pazjent fis-sena kien ta' madwar 0.2 b'Tecfidera meta mqabbel ma' 0.4 bi plaċebo.
English: It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Maltese: Jintuża speċifikament fl-adulti b'tip ta' MS magħrufa bħala MS ta' rikaduta-rimessjoni, fejn il-pazjent ikollu feġġa f'daqqa tas-sintomi (rikaduti) segwita minn perjodu ta' rkupru (remissjonijiet).
English: For the full list of all side effects reported with Tecfidera, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati b'Tecfidera, ara l-fuljett ta' tagħrif.
English: How does Tecfidera work?
Maltese: Kif jintuża Tecfidera?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Tecfidera's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija għaldaqstant iddeċieda li l-benefiċċji ta' Tecfidera jisbqu r-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Elimination half-life was estimated to be 13.76 + 6.42 hours.
Maltese: Il-half-life ta' eliminazzjoni kienet stmata li hija 13.76 + 6.42 sigħat.
English: Pharmacokinetics/pharmacodynamics data (PK/PD)
Maltese: Dejta farmakokinetika/farmakodinamika (PK/PD)
English: The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.
Maltese: L-applikazzjoni ġiet ippreżentata lill-Irlanda bħala Stat Membru ta' referenza u l-Belġju, idDanimarka, Franza, il-Ġermanja, il-Greċja, l-Italja, il-Lussemburgu, il-Pajjiżi l-Baxxi, il-Portugall, Spanja u r-Renju Unit bħala Stati Membri kkonċernati.
English: Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.
Maltese: Ilflorfenicol huwa strutturalment relatat ma' thiamphenicol u għandu profil farmakoloġiku simili.
English: Luxembourg Intervet International B.V. Wim de Körverstraat 35
Maltese: Lussemburgu Intervet International B.V.
English: • The MIC90 values of florfenicol are in the range 0.5 - 1 μg/ml for target pathogens M. haemolytica and P. multocida.
Maltese: • Il-valuri tal-MIC90 ta' florfenicol huma fil-medda ta' 0.5 - 1 μg/ml għall-patoġeni fil-mira M. haemolytica u P. multocida.
English: A florfenicol concentration of 4 x MIC (2 μg/ml) resulted in a decrease of bacterial count by 99.9% (3-Log drop) in 4 - 8 hours for the M. haemolytica isolates.
Maltese: (2 μg/ml) irriżultat fi tnaqqis fl-għadd ta' batterji b'99.9% (waqgħa ta' 3Log) f'4 - 8 sigħat għall-iżolati ta' M. haemolytica.
English: 4.9 Amounts to be administered and administration route
Maltese: .9 Doża rakkomandata u metodu ta' amministrazzjoni
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Maltese: Belġjum Intervet International B.V.
English: During the decentralised procedure two concerned Member States identified potential serious risks regarding the proposed indications (France) and the efficacy of the product (Denmark).
Maltese: Waqt il-proċedura deċentralizzata żewġ Stati Membri kkonċernati identifikaw riskji serji potenzjali rigward l-indikazzjonijiet proposti (Franza) u l-effikaċja tal-prodott (id-Danimarka).
English: Repeat administration of 20 mg/kg once daily for three days (proposed posology) resulted in some accumulation (accumulation factor of 1.48).
Maltese: L-għoti ripetut ta' 20 mg/kg darba kuljum għal tlett ijiem (pożoloġija proposta) irriżulta f'xi ftit akkumulazzjoni (fattur ta' akkumulazzjoni ta' 1.48).
English: The applicant Intervet International BV submitted an application for a decentralised procedure (DCP) for an extension (Article 19 of Regulation (EC) 1234/2008) of the existing marketing authorisation of Nuflor 300 mg/ml solution for injection for cattle to add sheep as a target species.
Maltese: L-applikant Intervet International BV issottometta applikazzjoni għal proċedura deċentralizzata (DCP) għal estensjoni (Artikolu 19 tar-Regolament (KE) 1234/2008) tal-awtorizzazzjoni eżistenti għat-tqegħid fis-suq ta' Nuflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat sabiex in-nagħaġ jiżdiedu bħala speċi fil-mira.
English: Similarly, a florfenicol concentration of 2 x MIC (0.5-1 μg/ml) resulted in a 3-Log drop of bacterial count in 10 - 24 hours for the P. multocida isolates.
Maltese: Bl-istess mod, konċentrazzjoni ta' florfenicol ta' 2 x MIC (0.5-1 μg/ml) irriżultat f'waqgħa ta' 3-Log fl-għadd ta' batterji f'10 - 24 siegħa għall-iżolati ta' P. multocida.
English: Nuflor 300 mg/ml solution for injection for cattle and sheep contains florfenicol as active substance.
Maltese: Nuflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat u n-nagħaġ fih is-sustanza attiva florfenicol.
English: • A variety of studies are available on the distribution of florfenicol in bronchial secretions in man and various animal species (pigs and calves).
Maltese: • Hemm diversi studji disponibbli dwar id-distribuzzjoni ta' florfenicol fi tnixxijiet tal-bronki filbniedem u diversi speċijiet ta' annimali (ħnieżer u għoġġiela).
English: For sheep, the proposed indication is for treatment of respiratory tract infections due to Mannheimia haemolytica (M. haemolytica) and Pasteurella multocida (P. multocida) susceptible to florfenicol at a dose of 20 mg florfenicol/kg bodyweight intramuscular daily for three consecutive days.
Maltese: Għan-nagħaġ, lindikazzjoni proposta hija għall-kura ta' infezzjonijiet tal-apparat respiratorju kkawżati minn Mannheimia haemolytica (M. haemolytica) u Pasteurella multocida (P. multocida) suxxettibbli għal florfenicol f'doża ta' 20 mg florfenicol/kg piż tal-ġisem fil-muskolu kuljum għal tlett ijiem konsekuttivi.
English: Secondary variables (e.g. mortality, pathogen recover, lung weight, lesion weight) confirm that 20 mg/kg is superior to a dose of 10 mg/kg.
Maltese: Varjabbli sekondarji (eż. mortalità, irkupru tal-patoġeni, piż tal-pulmun, piż tal-ġrieħi) jikkonfermaw li 20 mg/kg hija superjuri għal doża ta' 10 mg/kg.
English: Sheep:
Maltese: Xejn.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, routes of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodott veterinarju mediċinali, speċi tal-annimal,mod ta'amministrazzjoni, applikant fl-Istati Membri.
English: Pharmacokinetic studies showed that mean plasma concentrations remain above MIC90 (1 μg/ml) for up to 18 hours after administration of the product at the recommended treatment dose.
Maltese: Studji Farmakokinetiċi urew li l-konċentrazzjoni medja fil-plasma jibqgħu l-fuq MIC90 (1 μg/ml) sa 18 il-siegħa wara amministrazzjoni tal-prodott fid-doża rakkomandata tat-trattament.
English: Based on dossier data concerning Minimum Inhibitory Concentrations (MICs) for florfenicol (MIC90= 1 µg/ml) and considering its pharmacokinetic/pharmacodynamic (PK/PD) plasma profile, the period of exposure to the MIC90 strength was believed by the objecting Member State to be too short.
Maltese: Abbażi ta' dejta mid-dossier rigward il-Konċentrazzjonijiet Inibitorji Minimi (MICs) għal florfenicol (MIC90= 1 µg/ml) u meta wieħed iqis il-profil farmakokinetiku/farmakodinamiku (PK/PD) tal-plażma tiegħu, ilperjodu ta' espożizzjoni għall-qawwa tal-MIC90 kien ikkunsidrat qasir wisq mill-Istat Membru li oġġezzjona.
English: Overall summary of the scientific evaluation of Nuflor 300 mg/ml solution for injection for cattle and sheep
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Nuflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat u n-nagħaġ
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Maltese: DOŻA GĦAL KULL SPEĊI, MOD U METODU TA' AMMINISTRAZZJONI
English: The applicant provided detailed pharmacodynamic and pharmacokinetic data to justify the proposed dose for the claimed indication.
Maltese: L-applikant ipprovda dejta farmakodinamika u farmakokinetika dettaljata sabiex jiġġustifika d-doża proposta għall-indikazzjoni ddikjarata.
English: These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started.
Maltese: Dawn ilkwistjonijiet baqgħu ma ssolvewx u għalhekk bdiet referenza taħt l-Artikolu 33(1) tadDirettiva 2001/82/KE lis-CMD(v).
English: • The MIC and pharmacokinetic data, taken together with what is known about florfenicol kill kinetics and post-antibiotic effect, support the recommended treatment interval (24 hours) for target respiratory tract pathogens with MIC up to 1 μg/ml when the product is administered to sheep at the proposed dose of 20 mg florfenicol/kg bodyweight,
Maltese: • Id-dejta dwar l-MIC u d-dejta farmakokinetika, meħuda flimkien ma' dak li huwa magħruf dwar ilkinetika tal-qtil u l-effett post-antibijotiku ta' florfenicol, jappoġġjaw l-intervall ta' kura rakkomandat (24 siegħa) għall-patoġeni fil-mira tal-apparat respiratorju b'MIC sa 1 μg/ml meta lprodott jingħata lin-nagħaġ fid-doża proposta ta' 20 mg florfenicol/kg piż tal-ġisem,
English: Linear trend analyses of Day 4 and Day 6 rectal temperature data (primary variable) suggest that a dose response plateau was achieved at the florfenicol 20 mg/kg dosage.
Maltese: ta' Jum 4 u Jum 6 jissuġġerixxu li plateau ta' rispons għad-doża inkiseb bid-doża ta' 20 mg/kg florfenicol.
English: The CVMP accepted that the MIC and pharmacokinetic data, taken together with what is known about florfenicol kill kinetics and post-antibiotic effect (PAE), support the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml and suggest that the proposed dose of 20 mg florfenicol/kg and the proposed between treatment interval of 24 hours should be appropriate for testing in the clinical setting for the treatment of respiratory infection associated with M. haemolytica and P. multocida.
Maltese: Is-CVMP aċċetta li d-dejta dwar l-MIC u d-dejta farmakokinetika, meħuda flimkien ma' dak li huwa magħruf dwar il-kinetika tal-qtil u l-effett post-antibijotiku (PAE) ta' florfenicol, jappoġġaw l-intervall ta' kura rakkomandat (24 siegħa) għall-patoġeni fil-mira b'MIC sa 1 μg/ml u jissuġġerixxu li d-doża proposta ta' 20 mg florfenicol/kg u l-intervall ta' 24 siegħa propost ta' bejn il-kura għandu jkun xieraq għall-ittestjar fl-isfond kliniku għall-kura ta' infezzjoni respiratorja assoċjata ma' M. haemolytica u P. multocida.
English: The selected dose and between treatment interval was in line with the PK/PD conclusions.
Maltese: Id-doża magħżula u l-intervall ta' bejn il-kura kien konformi mal-konklużjonijiet dwar il-PK/PD.