FrancophonIA/ELRC3.0 huggingface dataset:
English: Buckinghamshire HP7 9FB
Maltese: HP7 9FB
English: Mannheimia haemolytica Cattle Staphylococcus aureus
Maltese: Mannheimia haemolytica Frat Staphylococcus aureus
English: Antimicrobial resistance
Maltese: Reżistenza antimikrobika
English: Ceva Animal Health Ltd Unit 3
Maltese: Ir-Renju Unit Ceva Animal Health Ltd Unit 3
English: Milk: 13.5 days.
Maltese: Ħalib: 13.5 jiem.
English: Mastitis:
Maltese: Mastite:
English: Ceva Animal Health Bulgaria Ltd 26 Elemag Str., ent.B, app.1 Sofia 1113
Maltese: Il-Bulgarija Ceva Animal Health Bulgaria Ltd 26 Elemag Str., ent.B, app.1
English: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne France
Maltese: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne Franza
English: Spiramycin is active against Staphylococcus aureus, Mannheimia haemolytica and Pasteurella multocida.
Maltese: Spiramycin huwa attiv kontra Staphylococcus aureus, Mannheimia haemolytica u Pasteurella multocida.
English: Data from clinical surveillance monitoring programs (VetPath I: 1997-2004, VetPath III: 2007-2012) show that a considerable proportion of bovine mastitis strains of S. aureus were susceptible to spiramycin in vitro, with MIC50 and MIC90 of 4 µg/ml and 8 µg/ml, respectively.
Maltese: Id-dejta minn programm ta' monitoraġġ tas-sorveljanza klinika (VetPath I: 1997-2004, VetPath III: 2007-2012) turi li parti konsiderevoli ta' razez ta' mastite fil-bovini ta' S. aureus kienet suxxettibbli għal spiramycin in vitro, b'MIC50 u MIC90 ta' 4 µg/ml u 8 µg/ml, rispettivament.
English: Meat and offal: 62 days.
Maltese: Laħam u ġewwieni: 62 jum.
English: Meat and offal: 75 days.
Maltese: Laħam u ġewwieni: 75 jum.
English: Rue de Bourgelat 17 69002 Lyon France
Maltese: Ir-Rumanija Merial Rue de Bourgelat 17 69002 Lyon Franza
English: Meat and offal: 68 days.
Maltese: Laħam u ġewwieni: 68 jum.
English: MIC of spiramycin (µg/mL) Range
Maltese: MIC ta' spiramycin (µg/mL) Medda
English: Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Maltese: Captalin soluzzjoni għall-injezzjoni fih 31.25 g spiramycin għal kull 100 ml, li jikkorrispondi għal 1 000 000 IU spiramycin għal kull ml.
English: La Ballastière 33500 Libourne France
Maltese: 33500 Libourne
English: Anglo Office Park White Lion Road Amersham
Maltese: Anglo Office Park
English: Merial Portuguesa - Saúde Animal, LDA Av. Maria Lamas, lote 19 - BL.
Maltese: Merial Portuguesa - Saúde Animal, LDA Av.
English: A limited resistant populaton was observed above 64 µg/ml.
Maltese: Kienet osservata popolazzjoni reżistenti limitata 'l fuq minn 64 µg/ml.
English: de la Ballastiere, BP 126 33500 Libourne Cedex FRANCE
Maltese: Ir-Rumanija Ceva Sante Animale Z.I. de la Ballastiere, BP 126 33500 Libourne Cedex FRANZA
English: Spiramycin is eliminated primarily by biliary excretion.
Maltese: Spiramycin huwa eliminat primarjament permezz ta' eskrezzjoni biljari.
English: In a worst-case scenario a AUC/MIC-ratio of 100-125 hours as target for spiramycin has been proposed.
Maltese: Fl-agħar xenarju ġie propost proporzjon AUC/MIC ta' 100-125 siegħa bħala mira għal spiramycin.
English: Ceva Sante Animale Z.I.
Maltese: Ceva Salute Animale S.p.A.
English: Applicant/Marketing Authorisation Holder
Maltese: Applikant/Detentur talAwtorizzazzjoni għat-Tqegħid fisSuq
English: The pharmacokinetic characteristics derived from specific studies demonstrated that in plasma relatively low spiramycin levels (Cmax: 6-10 IU/ml corresponding to 2-3 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in bronchoalveolar lavage (4-5-fold of the plasma levels) and in lung tissue (100-fold of the plasma levels).
Maltese: Il-karetteristiċi farmakokinetiċi derivati mill-istudji speċifiċi wrew li fil-plażma, bir-reġim ta' kura, intlaħqu livelli relattivament baxxi ta' spiramycin (Cmax: 6-10 IU/ml li jikkorrispondu għal 2-3 µg/ml), filwaqt li livelli ferm ogħla ta' spiramycin intlaħqu fil-ħasil bronkoalveolari (4-5 darbiet tal-livelli filplażma) u fit-tessut tal-pulmun (100 darba tal-livelli fil-plażma).
English: 29 avenue Tony Garnier 69007- Lyon France
Maltese: 29 avenue Tony Garnier 69007- Lyon Franza
English: The comparison of earlier with more recently determined MIC-data is, more over, complicated by the different laboratory methods used, and the fact that no break points validated for veterinary medicine exist.
Maltese: Barra minn hekk, it-tqabbil ta' dejta MIC preċedenti ma' dik iddeterminata aktar reċentement, huwa kkumplikat mill-metodi differenti tal-laboratorju użati, u mill-fatt li ma jeżistu ebda punti ta' waqfa għall-mediċina veterinarja.
English: Spiramycin is active against Mannheimia haemolytica and Pasteurella multocida, The following Minimum Inhibitory Concentrations (MIC) have been determined for spiramycin in European isolates collected from diseased animals between 2007 to 2012:
Maltese: Spiramycin huwa attiv kontra Mannheimia haemolytica u Pasteurella multocida, Il-Konċentrazzjonijiet Inibitorji Minimi (MIC) li ġejjin ġew iddeterminati għal spiramycin fl-iżolati Ewropej miġbura minn annimali morda bejn l-2007 sal-2012:
English: In pigs, the products has been authoresed for the treatment of respiratory infections, pig house cough, atrophic rhinitis, infections caused by Streptococcus spp., erysipelas, arthritis, treatment and prevention of mastitis, prevention of neonatal infections in piglets and infectious gastro-enteritis at 75 000 IU/kg body weight once or twice in 24 hour interval.
Maltese: Fil-ħnieżer, ilprodott ġie awtorizzat għall-kura ta' infezzjonijiet respiratorji, sogħla waqt it-trobbija tal-ħnieżer, rinite atrofika, infezzjonijiet ikkawżati minn Streptococcus spp., erisipela, artrite, il-kura u l-prevenzjoni ta' mastite, il-prevenzjoni ta' infezzjonijiet wara t-twelid fi qżieqeż u gastro-enterite infettiva f'doża ta' 75 000
English: Member State EU/EEA
Maltese: Membru talUE/ŻEE
English: Spiramycin is metabolised in the liver; its primary metabolite, neospiramycin, possesses antimicrobial activity.
Maltese: Spiramycin huwa metabolizzat fil-fwied; il-metabolit primarju tiegħu, neospiramycin, għandu attività antimikrobika.
English: The pharmacokinetic characteristics derived from this study demonstrate that in plasma relatively low spiramycin levels (Cmax: 1.44 IU/ml corresponding to 0.45 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in milk (50-fold of the plasma levels).
Maltese: Il-karetteristiċi farmakokinetiċi derivati minn dan l-istudju wrew li fil-plażma, intlaħqu livelli ta' spiramycin relattivament baxxi (Cmax: 1.44 IU/ml li jikkorrispondu għal 0.45 µg/ml) birreġim ta' kura, filwaqt li livelli kunsiderevolment ogħla ta' spiramycin intlaħqu fil-ħalib (50 darba l-livelli fil-plażma).
English: Cattle Mannheimia haemolytica Cattle
Maltese: Frat Mannheimia haemolytica Frat
English: Respiratory infections: 100 000 IU of spiramycin per kg body weight (i.e. 5 ml of product per 30 kg body weight) twice at 48 h of interval.
Maltese: Infezzjonijiet respiratorji: 100 000 IU ta' spiramycin għal kull kg piż tal-ġisem (jiġifieri 5 ml tal-prodott għal kull 30 kg piż tal-ġisem) darbtejn f'intervall ta' 48 siegħa.
English: Spiramycin acts on bacterial protein synthesis by binding to the 50S ribosomal subunits, inhibiting the translocation step.
Maltese: Spiramycin jaġixxi fuq is-sinteżi tal-proteini batteriċi billi jorbot mas-sottounitajiet ta' 50S ribosomal, u jinibixxi l-istadju ta' trażlokazzjoni.
English: The indication was substantiated by in vitro susceptibility data for Pasteurella multocida and Mannheimia haemolytica and by pharmacokinetic data of spiramycin in the target species, on the basis of which a detailed pharmacokinetic/pharmacodynamic (PK/PD) assessment has been performed.
Maltese: L-indikazzjoni kienet issostanzjata minn dejta dwar is-suxxettibbiltà in vitro għal Pasteurella multocida u Mannheimia haemolytica u minn dejta farmakokinetika ta' spiramycin fl-ispeċijiet li fuqhom kien ser jintuża l-prodott, abbażi ta' liema twettqet valutazzjoni farmakokinetika/farmakodinamika dettaljata (PK/PD).
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Maltese: Il-prodotti mediċinali veterinarji Suanovil 20 soluzzjoni għall-injezzjoni u l-prodott ġeneriku tiegħu huma soluzzjonijiet għall-injezzjoni li fihom 20 g spiramycin għal kull 100 ml, li jikkorrispondu għal 600 000
English: INDICATIONS Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica.
Maltese: INDIKAZZJONIJIET Kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica.
English: Mastitis: 30 000 IU of spiramycin per kg body weight (i.e. 5 ml of product per 100 kg body weight) twice at 24 h of interval.
Maltese: Mastite: 30 000 IU ta' spiramycin għal kull kg piż tal-ġisem (jiġifieri 5 ml tal-prodott għal kull 100 kg piż tal-ġisem) darbtejn f'intervall ta' 24 siegħa.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimal, applikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Mastitis caused by S. aureus should be treated once clinical signs are observed.
Maltese: Il-mastite kkawżata minn S. aureus għandha tiġi kkurata ladarba jiġu osservati s-sinjali kliniċi.
English: Spiramycine CEVA 600 000 UI/ML solution injectable pour bovins et porcins
Maltese: Spiramycine CEVA 600 000 UI/ML soluzzjoni injettabbli pour bovins et porcins
English: For the treatment of bovine respiratory diseases several appropriate clinical studies from 1988 and 1989 using the dose regime of 100 000 IU/kg body weight once or twice in 48 hours interval, have been presented.
Maltese: Għall-kura ta' mard respiratorju fil-bovini, ġew ippreżentati diversi studji kliniċi xierqa mill-1988 u l1989 permezz tar-reġim tad-dożaġġ ta' 100 000 IU/kg piż tal-ġisem darba jew darbtejn f'intervall ta' 48 siegħa.
English: Despite of several limitations, in particular the small number of animals and the short (14 days) observation period, the study was found appropriate to justify the indication ‘acute S. aureus mastitis', since results in the primary end point (bacteriological cure was reached in 7 out of 8 test cows, but in none of the 9 control cows) and some of the secondary endpoints (particularly the somatic cell count) were convincing.
Maltese: Minkejja diversi limitazzjonijiet, b'mod partikolari n-numru żgħir ta' annimali u l-perjodu ta' osservazzjoni qasir (14il jum), l-istudju nstab li huwa xieraq biex jiġġustifika l-indikazzjoni ‘mastite S. aureus' akuta, peress li r-riżultat fil-punt ta' tmiem primarju (kura batterjoloġika kienet intlaħqet f'7 minn 8 baqar tat-test, iżda fl-ebda mid-9 baqar tal-verifika) u xi wħud mill-punti ta' tmiem sekondarji (b'mod partikolari lgħadd ta' ċelloli somatiċi) kienu konvinċenti.
English: The veterinary medicinal product Suanovil 20 and its associated names has been authorised by several Member States for use in cattle for the treatment and prevention of respiratory infections and gastrointestinal infections, mastitis, metritis, omphalitis and omphalophlebitis, arthritis and interdigital abscesses at a dose of 30 000 IU/kg body weight once or twice in 24 hour interval for adult cattle and at 75 000 IU/kg body weight once or twice in 24 hour interval for calves.
Maltese: Il-prodott mediċinali veterinarju Suanovil 20 u ismijiet assoċjati ġie awtorizzat minn diversi Stati Membri għall-użu fl-ifrat għall-kura u l-prevenzjoni ta' infezzjonijiet respiratorji u infezzjonijiet gastrointestinali, mastite, metrite, onfalite u omfaloflebite, artrite u axxessi interdiġitali f'doża ta' 30 000
English: Spirovet 600 000 IU/ml инжекционен разрвор за говеда и свине/ Spirovet 600 000IU/ml solution for injection for cattle and pigs
Maltese: Spirovet 600 000 IU/ml инжекционен разрвор за говеда и свине/ Spirovet 600 000IU/ml soluzzjoni għallinjezzjoni għall-frat u l-ħnieżer
English: Spiramycin is an antimicrobial exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria.
Maltese: Spiramycin huwa antimikrobiku li jeżerċita azzjoni batterjostatika kontra l-batterji tal-Mikolażma, Gram-negattivi u Gram-pożittivi.
English: The clinical data on bovine mastitis consisted primarily of an experimental S. aureus mastitis study using a challenge strain with a spiramycin MIC of 4 µg/ml.
Maltese: Id-dejta klinika dwar il-mastite fil-bovini kienet tikkonsisti prinċipalment minn studju sperimentali dwar il-mastite S. aureus permezz ta' razza ta' sfida b'MIC ta' spiramycin ta' 4 µg/ml.
English: Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica.
Maltese: Kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica.
English: When applying these concepts it has been concluded that based on PK/PD-considerations in cattle, following 2 injections at 100 000 IU/kg body weight at 48 hours interval, the spiramycin concentrations in lung, macrophages and bronchoalveolar lavage reached the respiratory pathogens with MICs up to 128 µg/ml.
Maltese: Meta jiġu applikati dawn il-kunċetti, ġie konkluż li abbażi tal-kunsiderazzjonijiet PK/PD fl-ifrat, wara 2 injezzjonijiet f'100 000 IU/kg piż tal-ġisem f'intervall ta' 48 siegħa, il-konċentrazzjonijiet ta' spiramycin fil-pulmun, il-makrofagi u l-ħasil bronkoalveolari laħqu l-patoġeni respiratorji b'MICs sa 128 µg/ml.
English: Due to concerns related to efficacy, antimicrobial resistance and withdrawal periods, on 12 September 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Suanovil 20 and associated names, Captalin and associated names, and generic products thereof.
Maltese: Minħabba t-tħassib relatat mal-effikaċja, ir-reżistenza antimikrobika u l-perjodi ta' tiżmim, fit12 ta' Settembru 2012, il-Ġermanja ppreżentat lill-Aġenzija, notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE għal Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati u l-prodotti ġeneriċi tagħhom.
English: Following intramuscular injection, spiramycin is rapidly absorbed and maximal plasma concentrations are reached within 3 hours.
Maltese: Wara l-injezzjoni fil-muskolu, spiramycin jiġi assorbit rapidament u l-konċentrazzjonijiet massimi filplażma jintlaħqu fi żmien 3 sigħat.
English: However, in line with CVMP guideline on the conduct of bioequivalence studies in veterinary medicinal products (EMA/CVMP/016/00)3, product specific data are required to establish the residue depletion profile at the injection site.
Maltese: Madankollu, f'konformità mal-linja gwida tas-CVMP dwar it-twettiq tal-istudji ta' bijoekwivalenza fi prodotti mediċinali veterinarji (EMA/CVMP/016/00)3, hija meħtieġa dejta speċifika dwar il-prodott biex jiġi stabbilit il-profil ta' tnaqqis tar-residwi fis-sit tal-injezzjoni.
English: 4.1 Target species
Maltese: 4.1 Speċijiet fil-mira
English: Overall summary of the scientific evaluation of Suanovil 20 and associated names, Captalin and associated names and generic products thereof (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati u l-prodotti ġeneriċi tagħhom (ara Anness I)
English: Cattle.
Maltese: Frat.
English: By using the pharmacodynamic and pharmacokinetic data mentioned abobe, a detailed PK/PD assessment was performed, which was based on two parameters: the T>MIC (time during which the concentration exceeds the MIC), which is recommended for time-dependent antibiotics like the macrolides, and the AUC/MIC (area under the curve to MIC), which is recommended for specific macrolides like azithromycin.
Maltese: Permezz ta' dejta farmakodinamika u farmakokinetika msemmija hawn fuq, twettqet valutazzjoni PK/PD iddettaljata, li kienet ibbażata fuq żewġ parametri: it-T>MIC, li huwa rrakkomandat għal antibijotiċi dipendenti fuq il-ħin bħall-makrolidi, u l-AUC/MIC, li huwa rrakkomandat għal makrolidi speċifiċi bħal azithromycin.
English: Captalin solution for injection has been authorised by severeal Member States for use in cattle for the treatment of respiratory diseases at a dose of 100 000 IU/kg body weight twice at 48 hour interval and for the metaphylaxis of respiratrory diseases at a single dose of 100 000 IU/kg body weight.
Maltese: Is-soluzzjoni għall-injezzjoni Captalin ġiet awtorizzata minn diversi Stati Membri għall-użu fl-ifrat għallkura ta' mard respiratorju f'doża ta' 100 000 IU/kg piż tal-ġisem darbtejn f'intervall ta' 48 siegħa u għall-metafilażi ta' mard respiratorju f'doża waħda ta' 100 000 IU/kg piż tal-ġisem.
English: While for S. aureus this fraction amounted to less than 10% of the strains examined, the tri-modal MIC-distribution pattern obtained for S. uberis indicated that in addition to the susceptible fraction 10% of the strains examined had intermediate susceptibility and 20% were resistant.
Maltese: Filwaqt li għal S. aureus din il-parti tammonta għal anqas minn 10 % tar-razez eżaminati, il-mudell ta' distribuzzjoni tal-MIC trimodali miksub għal S. uberis indika li flimkien mal-parti tas-suxxettibbiltà, 10 % tar-razez eżaminati kellhom suxxettibbiltà intermedja u 20 % kienu reżistenti.
English: Spiramycin is a macrolide antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria which cause infections in cattle and pigs.
Maltese: Spiramycin huwa antibijotiku makrolidu li jeżerċita azzjoni batterjostatika kontra l-batterji talMikolażma, Gram-negattivi u Gram-pożittivi li jikkawżaw infezzjonijiet fl-ifrat u l-ħnieżer.
English: C. For Captalin and its associated names listed in Annex I containing 1 000 000 IU spiramycin per ml
Maltese: Għal Captalin u ismijiet assoċjati tiegħu elenkati flAnness I li fihom 1 000 000 IU spiramycin għal kull ml
English: Regarding bovine respiratory pathogens like Pasteurella multocida and Mannheimia haemolytica, in vitro MIC-values of spiramycin are generally high, but their mono-modal distribution pattern does not indicate a relevant resistant fraction.
Maltese: MIC in vitro ta' spiramycin huma ġeneralment għoljin, iżda d-distribuzzjoni mono-modali tagħhom ma tindika ebda parti reżistenti rilevanti.
English: Cattle (calves)
Maltese: Frat (għoġġiela)
English: Treatment of acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains sensitive to spiramycin.
Maltese: Kura ta' mastite klinika akuta kkawżata minn baqar li jreddgħu minn razez ta' Staphylococcus aureus sensittivi għal spiramycin.
English: Spiramycin is an antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria.
Maltese: Spiramycin huwa antibijotiku li jeżerċita azzjoni batterjostatika kontra l-batterji tal-Mikolażma, Gramnegattivi u Gram-pożittivi.
English: In these studies the efficacy of spiramycin had been compared to negative controls or to other antibiotics approved for these indications (oxytetracycline and tylosin).
Maltese: F'dawn l-istudji, l-effikaċja ta' spiramycin tqabblet ma' kontrolli negattivi jew ma' antibijotiċi oħrajn approvati għal dawn l-indikazzjonijiet (oxytetracycline u tylosin).
English: Its tissue distribution is extensive, with high concentration particularly in bronchial secretions, lung parenchyma, alveolar macrophages, udders and milk.
Maltese: Id-distribuzzjoni tat-tessut huwa estensiv, b'konċentrazzjoni għolja b'mod partikolari fi tnixxijiet tal-bronki, parenċima tal-pulmun, makrofaġi alveolari, bżieżel u ħalib.
English: The benefit-risk balance of Suanovil 20 and Spirovet is considered positive provided that their use in the treatment of mastitis will be limited to treatment of acute bovine S. aureus-mastitis caused by susceptible strains at a dose of 30 000 IU/kg administered intramuscularly twice at 24 hours of interval.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju ta' Suanovil 20 u Spirovet huwa kkunsidrat pożittiv sakemm l-użu tagħhom fil-kura ta' mastite jkun limitat għall-kura ta' mastite akuta S-auereus fil-bovini kkawżata minn razez suxxettibbli f'doża ta' 30 000 IU/kg mogħtija fil-muskolu darbtejn f'intervall ta' 24 siegħa.
English: The pharmacokinetic properties of spiramycin at the dose of 30 000 IU/kg body weight have been examined in one study.
Maltese: Il-proprjetajiet farmakokinetiċi ta' spiramycin fid-doża ta' 30 000 IU/kg piż tal-ġisem ġew eżaminati fi studju wieħed.
English: One study conducted at the recommended dose showed that the injection site muscle residues were below the maximum residue limit (200 μg/kg) at Day 52.
Maltese: Studju wieħed li twettaq fid-doża rakkomandata wera li r-residwi fil-muskolu tas-sit tal-injezzjoni kienu inqas mil-limitu tar-residwu massimu (200 μg/kg) fit-52 Jum.
English: One study was conducted at the recommended dose of 100 000 IU/kg body weight twice at 48 hours of interval, which showed that the injection site muscle residues were still above the maximum residue limit for muscle (200 μg/kg) at Day 49 post-treatment.
Maltese: Twettaq studju wieħed fid-doża rakkomandata ta' 100 000 IU/kg piż tal-ġisem darbtejn f'intervall ta' 48 siegħa, li wera li r-residwi tal-muskolu tas-sit tal-injezzjoni xorta kienu għadhom aktar mil-limitu massimu tar-residwi għall-muskolu (200 μg/kg) fid-49 Jum wara l-kura.
English: Regarding bovine mastitis pathogens such as S. aureus and S. uberis, there exists already a resistant proportion of strains, as evident from recent surveillance programs.
Maltese: Fir-rigward tal-patoġeni tal-mastite tal-bovini bħal S. aureus u S. uberis, diġà jeżisti proporzjon reżistenti ta' razez, kif inhuwa evidenti minn programmi ta' sorveljanza reċenti.
English: Spiramycin is able to reach so high tissue concentrations that it succeeds in penetrating into the cells to bind the 50S ribosomal subunits.
Maltese: Spiramycin jista' jilħaq konċentrazzjonijiet tant għoljin fit-tessuti li jirnexxilu jippenetra fiċ-ċelloli biex jorbot is-sottounitajiet ta' 50S ribosomal.
English: It should be noted that the generic product, Spirovet, has been authorised in several Member States for a restricted list of indications, only i.e. in adult cattle for the treatment of respiratory diseases, mastitis, metritis and interdigital necrobacillosis at a dose of 30 000 IU/kg once or twice in 24 hour interval.
Maltese: Għandu jiġi nnotat li l-prodott ġeneriku, Spirovet, ġie awtorizzat f'diversi Stati Membri għal lista ta' indikazzjonijiet ristretta, biss jiġifieri fi frat għall-kura ta' mard respiratorju, mastite, metrite u nekrobakillożi interdiġitali f'doża ta' 30 000 IU/kg darba jew darbtejn f'intervall ta' 24 siegħa.
English: Overall, the benefit-risk balance of all concerned products is considered positive provided their use will be limited to the treatment of bovine respiratory infections caused by susceptible strains of Pasteurella multocida and Mannheimia haemolytica at a dose of 100 000 IU/kg administered intramuscularly twice at 48 hours of interval.
Maltese: Minbarra l-valutazzjoni tal-effikaċja, id-doża rakkomandata għall-infezzjonijiet respiratorji fl-ifrat hija 100 000 IU/kg piż tal-ġisem, li tingħata fil-muskolu darbtejn f'intervall ta' 48 siegħa.
English: The recommended dose for acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains susceptible to spiramycin is 30 000 IU/kg body weight, intramuscularly twice at 24 hours of interval.
Maltese: Id-doża rakkomandata għal mastite klinika akuta f'baqar li jreddgħu kkawżata minn razez Staphylococcus aureus suxxettibbli għal spiramycin hija 30 000 IU/kg piż tal-ġisem, mogħtija filmuskolu darbtejn f'intervall ta' 24 siegħa.
English: Spiramycin levels in tissues and fluids were further increased when spiramycin was injected for a second time after 48 hours.
Maltese: Il-livelli ta' spiramycin fit-tessuti u l-fluwidi żdiedu aktar meta spiramycin kien injettat għat-tieni darba wara 48 siegħa.