FrancophonIA/ELRC3.0 huggingface dataset:
English: The objecting CMSs argued that the formulation of Docetaxel Teva Generics is not equivalent to the originator as a different excipient is used.
Maltese: Is-CMS li oġġezzjonaw argumentaw li l-formulazzjoni ta' Docetaxel Teva Generics mhijiex ekwivalenti għall-oriġinatur għaliex tintuża sustanza mhux attiva differenti.
English: This increased CMC makes it less likely that polysorbate micelles are indeed present in the blood stream, even very shortly after infusion.
Maltese: Din iżżieda fis-CMC tagħmilha inqas probabbli li l-miċelli ta' polysorbate huma verament preżenti fid-demm, anki ftit żmien wara l-infużjoni.
English: One of the points highlighted by the applicant was that the Loos et al data reviewed do not support changes in free fraction over a clinically relevant concentration range in vitro.
Maltese: Wieħed mill-punti li kien emfasizzat mill-applikant kien li d-dejta riveduta minn Loos et al ma tappoġġax tibdil fil-frazzjoni ħielsa fuq firxa ta' konċentrazzjoni klinikament rilevanti in vitro.
English: In the second round of this Referral, it was made clear that it is very unlikely that polysorbate 80 micelles remain present for 3 hours after infusion of Taxotere, with possible effect on Docetaxel pharmacokinetics.
Maltese: Fit-tieni fażi ta' dan ir-Riferiment, ġie magħmul ċari huwa ferm impossibbli li l-miċelli ta' polysorbate 80 jibqgħu preżenti għal 3 sigħat wara l-infużjoni ta' Taxotere, b'effett possibbli fuq il-farmakokinetika ta' Docetaxel.
English: In vitro protein binding data submitted during the initial procedure, CMD(h) referral procedure and the current CHMP referral procedure indicated that the dissociation pattern and protein binding is similar for docetaxel from Docetaxel Teva Generics and Taxotere at clinically relevant concentrations.
Maltese: Id-dejta dwar ir-rabta mal-proteini in vitro sottomessi waqt il-proċedura tal-bidu, ilproċedura ta' riferiment tas-CMD(h) u l-proċedura ta' riferiment attwali tas-CHMP indikat li lmudell ta' dissoċjazzjoni u r-rabta mal-proteini hija simili għal docetaxel minn Docetaxel Teva Generics u minn Taxotere f'konċentrazzjonijiet klinikament relevanti.
English: The aim of the assessment has been to clarify if systemic exposure to docetaxel from Taxotere and Docetaxel Teva Generics is equal.
Maltese: L-għan tal-valutazzjonijiet kien li jiċċaraw jekk l-espożizzjoni sistemika għal docetaxel minn Taxotere u Docetaxel Teva Generics hijiex ugwali.
English: Nevertheless taking into account all the information available in the case of Docetaxel Teva Generics, i.e the applicant's data, the evidence from literature submitted in support, as well the arguments presented at the oral explanation, the majority of the CHMP was of the view that sufficient reassurance is provided by the applicant that systemic exposure to the active ingredient between the innovator Taxotere and Docetaxel Teva Generics indeed is the same, and therefore safety and efficacy related to docetaxel will be the same as well.
Maltese: Madankollu meta tqieset l-informazzjoni kollha disponibbli fil-każ ta' Docetaxel Teva Generics, jiġifieri d-dejta tal-applikant, l-evidenza mid-dokumentazzjoni sottomessa b'appoġġ, kif ukoll largumenti ppreżentati waqt l-ispjegazzjoni orali, il-maġġoranza tas-CHMP kienu tal-fehma li hija pprovduta riassigurazzjoni suffiċjenti mill-applikant li espożizzjoni sistemika għall-ingredjent attiv bejn l-innovatur Taxotere u Docetaxel Teva Generics hija tabilħaqq l-istess, u għalhekk is-sigurtà u l-effikaċja fir-rigward ta' docetaxel huma wkoll l-istess.
English: Published data show that the concentration of polysorbate 80 following infusion of Taxotere in actual patients falls down to below the critical micelle concentration (CMC) in plasma immediately during infusion.
Maltese: wara infużjoni ta' Taxotere f'pazjenti reali taqa' taħt il-konċentrazzjoni kritika ta' miċelli (CMC) fil-plażma immedjatament wara l-infużjoni.
English: Therefore the main point for discussion was whether the free fraction immediately after infusion of Taxotere and Docetaxel Teva Generics is the same, and whether the docetaxel is released at a sufficiently equal rate from the Taxotere micelles and the Docetaxel Teva Generics HP-b-CD.
Maltese: Għalhekk, il-punt ewlieni għad-diskussjoni kien jekk il-frazzjoni ħielsa immedjatament wara l-infużjoni ta' Taxotere u Docetaxel Teva Generics hijiex l-istess, u jekk docetaxel huwiex rilaxxat b'rata ugwali biżżejjed mill-miċelli ta' Taxotere u Docetaxel Teva Generics HP-b-CD.
English: With regard to safety related to the excipients, it was considered by the RMS that the different excipients povidone K12 and HP-b-CD are being used in other medicinal products for intravenous use, and thus have been applied in humans.
Maltese: Fir-rigward ta' sigurtà relatata mas-sustanzi mhux attivi, l-RMS ikkunsidra li s-sustanzi mhux attivi differenti povidone K12 u HP-b-CD qegħdin jintużaw minn prodotti mediċinali oħra għall-użu ġolvini, u għalhekk ġew applikati għall-bnedmin.
English: Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Maltese: Il-Belġju, ir-Repubblika Ċeka, ilĠermanja, il-Greċja, Spanja, Franza, lItalja, l-Olanda, il-Polonja, il-Portugall u s-Slovakja
English: Store below 30 ºC.
Maltese: Aħżen f'temperaturi anqas minn 30 ºC.
English: E-08950 Esplugues de Llobregat (Barcelona) Spain Tel: +34 934 706 270
Maltese: Esplugues de Llobregat (Barċelona) Spanja Tel: +34 934 706 270
English: It is active against: Pasteurella multocida and Bordetella bronchiseptica
Maltese: Pasteurella multocida u Bordetella bronchiseptica
English: Oral bioavailability of doxycycline ranges between 50-60% values.
Maltese: Il-bijodisponibilità orali ta' doxycycline tvarja bejn il-valuri ta' 50 u 60%.
English: (1) Pharmacovigilance - reporting a nil return for suspected adverse drugs reactions and lack of efficacy; and
Maltese: (1) Framkoviġilanza - rapportaġġ ta' ebda ritorn għal reazzjonijiet negattivi suspettati dwar droga u nuqqas ta' effikaċja; u
English: Adverse reactions (frequency and seriousness)
Maltese: Effetti mhux mixtieqa (frekwenza u gravità)
English: Pivotal clinical trial with Doxycyline 10% premix
Maltese: Prova klinika ewlenija bi Doxycyline 10% premix
English: For Time to clinical cure, Doxyprex at 200ppm and at 300ppm groups were cured at 3.2 and 3.33 days respectively compared to the TM550 group at 8.2 days, the Stabox group at 11.75 days and the control group at 13.67 days.
Maltese: Għal Żmien għal kura klinika, gruppi fuq Doxyprex 200ppm u 300ppm ġew ikkurati f'3.2 u 3.33 jiem rispettivament meta mqabbla mal-grupp TM550 ta' 8.2 jiem, il-grupp Stabox ta' 11.75 jiem u lgrupp ta' kontroll ta' 13.67 jiem.
English: PACKAGE SIZE 1 kg
Maltese: DAQS TAL-PAKKETT 1 kg
English: related to “normal” food consumption.
Maltese: Fir-rigward ta' konsum ta' ikel “normali”.
English: Less emphasis should be put on the standard incorporation of 250 ppm.
Maltese: Għandu jkun hemm inqas enfażi fuq linkorporazzjoni standard ta' 250 ppm.
English: The submitted references supported pharmacodynamics including MIC data (more than 5 years old) and pharmacokinetics of the active substance, doxycycline.
Maltese: Ir-referenzi ppreżentati appoġġaw il-farmakodinamiċi inkluż id-data MIC (aktar minn 5 snin) u farmakokinetika tas-sustanza attiva, doxycycline.
English: “In Spain during 2001, the in vitro sensitivity to doxycycline has been determined against porcine strains of Pasteurella multocida and Bordetella bronchiseptica resulting in MIC90 values of 0.795µg/ml and 0.053µg/ml respectively.”
Maltese: “Fi Spanja matul l-2001, is-sensittività in vitro għal doxycycline kienet stabbilita kontra razez ta' batterji tal-qżieqeż ta' Pasteurella multocida u Bordetella bronchiseptica li rriżultat f'valuri MIC90 ta' 0.795 µg/ml u 0.053 µg/ml rispettivament.
English: The applicant provided evidence of efficacy of the active substance, doxycycline, against M.hyopneumoniae in pigs from published literature and from MIC studies.
Maltese: L-applikant ipprovda prova ta' l-effikaċja tas-sustanza attiva, doxycycline, kontra M.hyopneumoniae fil-majjali minn letteratura ppubblikata u minn studji tal-MIC.
English: Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Maltese: Skond l-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendat, il-kwistjoni ġiet riferuta lis-CVMP.
English: In order to establish that Doxyprex is similarly bioavailable to the product Pulmodox 5% Premix, the applicant referred to information from the SPC and the hevra.org website.
Maltese: Sabiex jiġi stabbilit li Doxyprex huwa bijodisponibbli b'mod simili għall-prodott Pulmodox 5% Premix, l-applikant irrefera l-informazzjoni mill-SPC u l-websajt hevra.org.
English: This is in agreement with the German Competent National Authority (BVL) and expert opinion.
Maltese: Dan huwa ftehim ma' l-Awtorità Nazzjonali Kompetenti Ġermaniża (BVL) u l-opinjoni esperta.
English: Cross-resistance is frequent between tetracyclines.
Maltese: Reżistenza inkroċjata hi frekwenti bejn tetracyclines.
English: Nature and composition of immediate packaging Containers of 1 kg, 5 kg, 20 kg and 25 kg.
Maltese: Kontenituri ta' 1 kg, 5 kg, 20 kg u 25 kg.
English: Pulmodox is indicated for prevention of clinical respiratory disease and not for treatment,
Maltese: Pulmodox huwa indikat għall-prevenzjoni tal-mard respiratorju kliniku u mhux għal trattament,
English: Tetracyclines, ATCvet code: QJ01AA02.
Maltese: QJ01AA02.
English: In addition, a negative control was used.
Maltese: Barra minn hekk, intuża kontroll negattiv.
English: 100 mg of Doxycycline base as hyclate
Maltese: 100 mg ta' bażi ta' Doxycycline bħala hyclate
English: In the 5 kg, 20 kg and 25 kg presentations, bags contain an additional intermediate nylon layer.
Maltese: Fil-preżentazzjonijiet tal-5 kg, 20 kg u 25 kg, il-boroż fihom saff addizzjonali intermedju tan-nylon.
English: There are however differences in both dose recommendation (12.5 mg/kg/day versus 10 mg/kg/day) and duration of treatment (8 versus 7 days).
Maltese: Hemm madankollu differenzi kemm fid-doża rakkomandata (12.5 mg/kg/ġurnata kontra 10 mg/kg/ġurnata) kif ukoll fit-tul ta' żmien tat-trattament (8 kontra 7 ijiem).
English: Semoline is employed as carrier.
Maltese: Semoline jintuża bħala carrier.
English: The applicant felt that this was more adapted towards the Guideline EMEA/CVMP/816/00 and obtained greater clinical significance.
Maltese: Lapplikant ħass li din kienet adattata aktar għal-Linja gwida EMEA/CVM/816/00 u kisbet sinifikanza klinika akbar.
English: Frequency and route of administration
Maltese: Frekwenza u rotta ta' amministrazzjoni
English: The CVMP/627/01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Maltese: Il-linja gwida CVM/627/01 u l-GCP iddikjaraw li t-tweġiba għat-terapija għandha tkun ibbażata fuq kriterji kliniċi u mikrobioloġiċi kull fejn possibbli.
English: E-08950 Esplugues de Llobregat (Barcelona) Spain
Maltese: Esplugues de Llobregat (Barċelona) Spanja
English: Product invented name
Maltese: Isem tal-prodott inventat
English: Therapeutic concentrations have been detected in watery humor, myocardium, reproductive tissues, brain and mammary gland.
Maltese: Konċentrazzjonijiet terapewtiċi kienu osservati fil-watery humor, fil-mijokardju, fit-tessut riproduttiv, fil-moħħ u u fil-glandola mammarja.
English: List of excipients
Maltese: Lista ta' ingredjenti
English: In the answer to the CVMP question the applicant has not discussed or justified the two doses (200ppm and 300ppm) of Doxyprex applied in the clinical trial.
Maltese: Bi tweġiba għall-mistoqsija ta' CVMP l-applikant ma ddiskutiex jew ma ġġustifikax iż-żewġ dożi (200ppm u 300ppm) ta' Doxyprex applikati fil-prova klinika.
English: Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Maltese: Ġaladarba tkun assorbita, ilmediċina teħel f'perċentwali għoli ħafna (93%) mal-proteini plażmatiċi.
English: Doxycycline is a broad spectrum antibiotic with bacteriostatic activity that acts by interfering on the bacterial protein synthesis of the sensitive species.
Maltese: Doxycycline hu antibijotiku broad spectrum b'attività batterjostatika li taġixxi billi tinterferixxi fuq issintesi tal-proteini batterjali ta' l-ispeċi sensittiva.
English: New secondary end points were defined as percentage clinically cured on day 7 relapse and mortality rates.
Maltese: Punti ta' tmiem sekondarji ġodda kienu definiti bħala perċentwali ta' kurati klinikament fis-7 jum rati ta' reċidiva u mortalità.
English: Do not administer in conjunction with bactericidal antibiotics like beta-lactames.
Maltese: Tagħtix flimkien ma' antibijotiċi batteriċidjali, bħal beta-lactames.
English: Deficiencies in the pivotal clinical trial demonstrating efficacy of the product for the treatment of P.multocida and B. bronchiseptica were compensated for by a discussion of the field data in the literature reference provided.
Maltese: Id-defiċjenzi fil-prova klinika ewlenija li turi l-effikaċja tal-prodott għat-trattament ta' P.multocida u B. bronchiseptica ġew ikkompensati b'diskussjoni tad-data fil-qasam fir-referenza tal-letteratura pprovduta.
English: Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “For treatment of swine respiratory disease caused by susceptible Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to doxycycline.”
Maltese: Wara diskussjonijiet fis-CMD(v), l-indikazzjoni proposta ġiet mibdula matul il-kors tal-MRP għal: “Għal trattament tal-marda respiratorja fil-majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae suxxettibbli għal doxycycline.”
English: Before granulation, flour should not reach a temperature higher than 55 ºC.
Maltese: Qabel jitfarrak, it-tqiq m'għandux jilħaq temperatura ogħla minn 55ºC.
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg thermosealed bags containing 100 mg/g doxycycline base as hyclate.
Maltese: Doxyprex 100 mg premix ippreżentat f'boroż magħluqin bis-sħana ta' 5 kg, 20 kg u 35 kg li fihom 100 mg/g ta' bażi ta' doxycyline bħala hyclate.
English: A 40% of the drug is metabolised and largely excreted in faeces (bile and intestinal route), mostly as conjugates microbiologically inactive.
Maltese: 40% tal-mediċina ikun metabolat u fil-biċċa l-kbira tiegħu jitneħħa ma' l-ippurgar (rotta biljari u intestinali), l-iktar bħala konjugati mikrobijoloġikament inattivi.
English: The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix.
Maltese: Is-CVMP waqt il-laqgħa tiegħu tal-21-22 ta' Ġunju 2006 beda proċedura ta' referenza taħt l-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendat, għal Doxyprex 100 mg premix.
English: Avoid handling the product if hypersensitivity to tetracyclines exists.
Maltese: Evita l-immaniġġjar tal-prodott jekk teżisti sensittività eċċessiva għat-tetracyclines.
English: Following single dose administration, Cmax was 1.70 µg/ml with a Tmax of 6 hours.
Maltese: Wara l-għoti ta' doża waħda, is-Cmax kienet ta' 1.70 µg/ml b'Tmax ta' 6 sigħat.
English: Provided its lipophilic properties doxycycline is easily distributed in animal tissues, showing volumes of distribution of 0.53 l/kg.
Maltese: Minħabba l-proprjetajiet lipofiliċi tiegħu, doxycycline jiġi ddistribwit faċilment fit-tessut ta' l-annimal, u juri volumi tad-distribuzzjoni ta' 0.53 l/kg.
English: According to the Clinical and Laboratory Standard (CLSI) regulation, organisms other than streptococci with MIC values ≤ 4 µg/ml are considered sensitive, at 8 µg/ml intermediate and with MIC values ≥ 16 resistant to doxycycline.
Maltese: MIC ta' ≤ 4 µg/ml huma kkunsidrati li huma sensittivi, f'valuri intermedji ta' 8 µg/ml, u valuri MIC ta' ≥ 16 reżistenti għal doxycycline.
English: It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
Maltese: Hu rakkomandat li tuża maskra mhux tat-trab (skond regolament EN140FFP1), ingwanti, libsa taxxogħol u nuċċalijiet approvati tas-sigurtà .
English: In Spain the product has been authorised for the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Maltese: Fi Spanja l-prodott ġie awtorizzat għall-indikazzjoni tat-trattament tal-marda respiratorja fil-majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae.
English: Semolinea (declared on labelling as carrier)
Maltese: Semolinea (iddikjarata fuq it-tikketta bħala carrier) 6.2.
English: Similar products with 8 or 10 days treatment durations are also available within the EU.
Maltese: Prodotti simili bi trattament li jdum 8 jew 10 ijiem huma disponibbli wkoll fi ħdan l-UE.
English: Pelleting conditions involve preconditioning ingredients with steam at 55-65ºC and 10% moisture.
Maltese: Il-kundizzjonijiet ta' likel imnixxef u ppreparat minn qabel jinvolvu li l-ingredjenti jkunu pre-kundizzjonati bil-fwar f'temperatura ta' 55-65ºC u umdità ta' 10%.
English: In addition the pharmacokinetics study using their final formulation and more up-to-date (2001) MIC data for respiratory pathogens isolated from pigs in Spain are provided.
Maltese: Barra minn hekk l-istudju farmakokinetiku uża l-formulazzjoni finali tagħhom u hemm ipprovdut data (2001) ta' MIC aktar aġġornata għal patoġeni respiratorji iżolati minn majjali fi Spanja.
English: The actual groups of pigs studied were all showing clinical signs.
Maltese: Il-gruppi propja ta' majjali studjati kienu kollha qed juru sinjali kliniċi.
English: From all this information, a significant potential serious risk for safety or efficacy of Doxyprex, for the treatment or control of clinical signs of porcine respiratory disease caused by P.multocida and B.bronchiseptica cannot be identified.
Maltese: Minn din linformazzjoni kollha, riskju serju potenzjali sinifikanti għas-sigurtà jew l-effikaċja ta' Doxyprex, għat trattament jew il-kontroll ta' sinjali kliniċi ta' mard respiratorju fil-majjali ikkaġunat minn P.multocidau B.bronchiseptica ma jistax jiġi identifikat.
English: 1 mg Doxyprex/kg feed = 10 mg doxycycline/kg b.w.
Maltese: 1 mg ta' Doxyprex/kg ta' għalf = 10 mg ta' doxycycline/kg p.ġ. x 10 x piż tal-ġisem (kg)/Konsum ta' kuljum ta' l-għalf (kg)
English: A risk:benefit analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Maltese: Ma setgħetx titwettaq analiżi tar-riskju: benefiċċju minħabba nuqqas ta' provi ewlenin dwar l-effikaċja klinika għall-indikazzjoni M. hyopneumoniae.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Industrial Veterinaria, S.A.
Maltese: U L-INDIRIZZ TAS-SID TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ Industrial Veterinaria, S.A.
English: Doxycycline is a semi-synthetic tetracycline derived from oxytetracycline that acts on the 30S ribosomal bacterial subunit in a reversible union, by blocking the binding of aminoacyl-tRNA (transference RNA) to the mRNA/ribosome complex, avoiding the addition of new amino acids to the growing peptide chain and interfering therefore on the protein synthesis.
Maltese: Doxycycline hu tetracycline semi-sintetiku li jinkiseb minn oxytetracycline li jaġixxi fuq is-sotto-unità batterjali tar-ribosom 30S f'unjoni riversibbli, billi jimblokka t-twaħħil ta' aminoacyl-tRNA (transference RNA) mal-kumpless mRNA/ribosom, u jevita ż-żieda ta' amino acids ġodda mal-katina tal-peptide li tkun qed tikber u għalhekk, jinterferixxi fuq il-proċess tas-sintesi tal-proteina.
English: METHOD AND ROUTE(S) OF ADMINISTRATION In feed use
Maltese: Doża rakkomandata u l-metodu ta' amministrazzjoni
English: 100 mg/g Pigs (after weaning)
Maltese: 100 mg/g Majjali (wata lftim)
English: The Committee agreed that all prudent use recommendations should be put under 4.5.
Maltese: Il-Kumitat qabel li r-rakkomandazzjonijiet kollha għal użu prudenti għandhom jitqiegħdu taħt 4.5.
English: Alteration in the transport system is produced by inducible proteins codified in plasmids and transposons.
Maltese: Il-bidla fis-sistema tat-trasport tiġi prodotta mill-proteini inducible li huma kkodifikati fil-plasmids u transposons.
English: For the second clinical study “ Efficacy of the doxycycline in feed for the control of pneumonia caused by P. multocida and Mycoplasma hyopneumoniae
Maltese: Għat-tieni studju kliniku “L-effikaċja ta' doxycyline fl-għalf għall-kontroll tal-pnewmonja kkaġunata minn P. multocida u Mycoplasma hyopneumoniae
English: PACKAGE LEAFLET Doxyprex 100 mg/g Premix
Maltese: FIL-PAKKETT Doxyprex 100 mg/g Taħlita għall-Lest
English: Do not use after the expiry date.
Maltese: Tużax wara d-data ta' l-iskadenza.
English: Excipients:
Maltese: OĦRA
English: Food can slightly modify oral bioavailability of doxycycline.
Maltese: L-ikel jista' jimmodifika xi ftit il-bijodisponibilità orali ta' doxycycline.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI
English: Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
Maltese: Il-Ġermanja nnotifikat lill-EMEA fit-30 ta' Mejju 2006 li s-CMD(v) ma rnexxilux jilħaq ftehim firrigward tal-prodott.
English: Piglet starter feed I (complete feed up to approx. 20 kg body weight) Piglet starter feed II (complete feed up to approx. 35 kg body weight) Complete feed for fattening pigs up to approx. 50 kg body weight Complete feed for fattening pigs of approx. 50 kg body weight Complete feed for fattening pigs of approx. 35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Maltese: Għalf tal-bidu għal qżieqeż żgħar II (għalf sħiħ sa madwar 35 kg ta' piż tal-ġisem) Għalf sħiħ għas-simna tal-qżieqeż sa madwar 50 kg ta' piż tal-ġisem Għalf sħiħ għas-simna tal-qżieqeż ta' madwar 50 kg ta' piż tal-ġisem Għalf sħiħ għas-simna tal-qżieqeż ta' madwar 35 kg ta' piż tal-ġisem Ribbon mixer orizzontali għandu jintuża biex iżied il-prodott ġo l-għalf.
English: A new primary end point was defined as Time to clinical cure, i.e. the time to absence of clinical signs.
Maltese: Punt ta' tmiem primarju ġdid kien definit bħala Żmien għal kura klinika, jiġifieri, iżżmien għall-assenza ta' sinjali kliniċi.
English: The CVMP recommendation is to grant the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs the following suggested indication because a positive risk:benefit analysis has been demonstrated and no potential serious risk has been identified.
Maltese: Ir-rakkomandazzjoni ta' CVMP hija li tagħti awtorizzazzjoni ta' kummerċjalizzazzjoni għal Doxyprex 100 mg/g Premix għal oġġetti ta' l-għalf medikati għall-majjali bl-indikazzjoni ssuġġerita li ġejja peress li intweriet analiżi riskju:benefiċċju pożittiva u ma ġie identifikat ebda riskju serju potenzjali.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Doxyprex 100 mg/g Premix
Maltese: VETERINARJU Doxyprex 100 mg/g Taħlita għall-lest
English: Mixing instructions:
Maltese: Struzzjonijiet tat-taħlit:
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: 3. DIKJARAZZJONI TAS-SUSTANZA(I)
English: The other mechanism is evidenced by a reduction in the affinity of the ribosome for the Tetracycline-Mg2+ complex due to mutations in the chromosome.
Maltese: Il-mekkaniżmu l-ieħor jidher permezz ta' tnaqqis fl-affinità tar-ribosom għall-kumpless Tetracycline-Mg2+ minħabba l-mutazzjonijiet fil-kromosoma.
English: Farms were selected if at least 20% of pigs were showing clinical signs of respiratory disease.
Maltese: L-irziezet intagħżlu jekk mill-inqas 20% tal-majjali kienu qed juru sinjali kliniċi ta' mard respiratorju.
English: Administration of the product according to the recommended posology results in a maximum plasmatic concentration at steady of 2.0 ± 0.4 µg/ml .
Maltese: L-għoti tal-prodott skond il-pożoloġija rakkomandata tirriżultata f'konċentrazzjoni plażmatika massima fl-istat fiss ta' 2.0 ±0.4 µg/ml.