FrancophonIA/ELRC3.0 huggingface dataset:
English: FOLDING BOX AND LABEL FOR BOTTLE for 150 mg
Maltese: KAXXA LI TINTEWA U TIKKETTA GĦAL FLIXKUN għal 150 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/015
Maltese: EU/1/08/442/015
English: Dose reduction recommended Patients aged ≥80 years daily dose of 220 mg Pradaxa taken as one 110 mg capsule twice daily
Maltese: Jekk għandek 80 sena jew aktar, id-doża rakkomandata ta' Pradaxa hija ta' 220 mg li tittieħed bħala kapsula waħda ta' 110 mg darbtejn kuljum.
English: Table 14 shows bleeding events in the pooled pivotal studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Tabella 14 turi avvenimenti ta' ħruġ ta' demm fl-istudji miġbura importanti ħafna RE-COVER u RECOVER II li ttestjaw il-kura ta' trombożi tal-vini profondi (DVT) u emboliżmu pulmonari (PE).
English: Assessment of renal function prior to and during Pradaxa treatment In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:
Maltese: Fil-pazjenti kollha u speċjalment fl-anzjani (> 75 sena), peress li insuffiċjenza tal-kliewi tista' tkun frekwenti f'dan il-grupp ta' età:
English: Gastroesophageal reflux disease
Maltese: Mard ta' rifluss gastroesofageali
English: Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein - Blood-stained discharge from the site of entry of a catheter into a vein - Coughing of blood or blood stained sputum - A fall in the number of platelets in the blood - A fall in the number of red cells in the blood after an operation - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel (incl.
Maltese: - Tnixxija ta' likwidu bid-demm mis-sit minn fejn il-kateter jidħol ġo vina - Sogħla bid-demm jew bili bid-demm - Tnaqqis fin-numru ta' plejtlits fid-demm - Tnaqqis fin-numru ta' ċelluli ħomor fid-demm wara operazzjoni - Reazzjoni allerġika serja li tikkawża diffikultà biex tieħu n-nifs jew sturdament - Reazzjoni allerġika serja li tikkawża nefħa fil-wiċċ jew fil-gerżuma - Raxx tal-ġilda li jkun notevoli għal ponot ħomor skuri, imqabbżin, u bil-ħakk, ikkawżati minn reazzjoni allerġika - Bidla f'daqqa fil-ġilda li taffettwa l-kulur u d-dehra tagħha - Ħakk - Ulċera fl-istonku jew fl-imsaren (li tinkludi ulċera fl-esofagu) - Infjammazzjoni tal-griżmejn u l-istonku - Rifluss ta' fluwidu gastriku ġol-gerżuma - Uġigħ ta' żaqq jew uġigħ fl-istonku - Indiġestjoni - Diffikultà biex tibla' - Fluwidu li joħroġ minn ferita - Fluwidu li joħroġ minn ferita wara operazzjoni
English: When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind (idarucizumab) may be considered (see section 4.9 Management of bleeding complications).
Maltese: Meta jseħħ ħruġ ta' demm sever, it-trattament għandu jitwaqqaf, is-sors ta' ħruġ ta' demm għandu jkun investigat u jista' jiġi kkunsidrat użu tas-sustanza speċifika tat-treġġigħ lura Praxbind (idarucizumab) (ara sezzjoni 4.9 Immaniġġjar ta' komplikazzjonijiet ta' ħruġ ta' demm).
English: Treated patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 200 ng/mL,
Maltese: th percentile tal-konċentrazzjonijiet fil-plażma ta' dabigatran imkejla fil-livell minimu (10-16-il siegħa wara d-doża ta' qabel) kienet ta' madwar 200 ng/mL,
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 2 above and section 4.4).
Maltese: Għal persuni b'gastrite, esofagite, jew rifluss gastroesofagali, tnaqqis fid-doża jista' jiġi kkunsidrat minħabba r-riskju għoli ta' ħruġ ta' demm gastrointestinali maġġuri (ara tabella 2 hawn fuq u sezzjoni 4.4).
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a phase III clinical trial comparing dabigatran to warfarin for stroke prevention in atrial fibrillation patients (RE-LY).
Maltese: Ma kienx hemm differenzi statistiċi fil-komponenti individwali tal-punti finali taleffikaċja bejn iż-żewġ gruppi ta' terapija doppja b'dabigatran etexilate u terapija tripla b'warfarin.
English: The Boehringer Ingelheim logo is printed on the cap and “R150” on the body of the capsule.
Maltese: Il-logo ta' Boehringer Ingelheim hu stampat fuq l-għatu u “R150” fuq il-korp tal-kapsula.
English: which would be 1.8-fold compared to baseline.
Maltese: 62 sekonda, li hi 1.8 darbiet meta mqabbla mal-linja bażi.
English: Per ml solution Trimethoprim20.0 mg
Maltese: Kull ml ta' soluzjoni Trimethoprim20.0 mg
English: HDPE bottle / can: volume 1000 ml / 5000 ml.
Maltese: HDPE flixkun / bott: volum 1000 ml / 5000 ml.
English: Hypersensitivity reactions can occur rarely.
Maltese: Reazzjonjiet ħipersensittivi jistgħu jiġru rarament.
English: Broilers:
Maltese: Brojlers:
English: Excipients: N-methyl-pyrrolidone
Maltese: N-methyl-pyrrolidone
English: Trimethoprim 20 mg/ml Sulfamethoxazole 100 mg/ml N-Methyl-2
Maltese: Trimethoprim 20 mg/ml Sulfamethoxazole 100 mg/ml N-Methyl-2pyrrolidone
English: Methoxasol-T As for The Netherlands
Maltese: Methoxasol-T Bħal ta' l-Olanda
English: 5.1: Delete MIC data
Maltese: .1: Ħassar dejta MIC
English: The Cmax of trimethoprim is 0.29 µg/g.
Maltese: Is-Cmax tat-trimethoprim hija 0.29 µg/g.
English: 5530 AD Bladel
Maltese: 5530 AD Bladel L-Olanda
English: The dossier submitted to the Netherlands was only bibliographic.
Maltese: Id-dossier sottomess lill-Olanda kien biblijografiku biss.
English: 4.11 Withdrawal period
Maltese: 4.11 Perijodu ta' irtirar
English: Propylene glycol, Sodium hydroxide, Water, purified, N-methyl-pyrrolidone
Maltese: Propylene glycol Idrossidu tas-Sodju Ilma, purifikat N-methyl-pyrrolidone
English: Trimethoprim is a diaminopyrimidine, a synthetic folic acid antagonist.
Maltese: It-Trimethoprim huwa dijaminopirimidin, aċidu antagonist foliku sintetiku.
English: N-methyl-pyrrolidone For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti, ara s-sezzjoni 6.1.
English: Staphylococcus aureus, Salmonella enteritidis, E. coli.
Maltese: Tiġieġ imkabbar għal-laħam Staphylococcus aureus, Salmonella enteritidis, E.coli.
English: Handelsweg 25 P.O.
Maltese: Handelsweg 25, P.O. Box 179,
English: SPC harmonisation
Maltese: Armonizzazzjoni ta' l-SPC
English: Methoxasol-T Solution for oral administration
Maltese: Methoxasol-T Soluzjoni għallamministrazzjoni orali
English: The CVMP can accept the proposed revision of the indication:
Maltese: Is-CVMP jista' jaċċetta r-reviżjoni proposta ta' l-indikazzjoni:
English: 5.2: protein binding for TMP and SMX is not high (TMP 50, SMX 60), but the overall proposal of the MAH can be accepted.
Maltese: 5.2: l-irbit mal-proteini għal TMP u SMX mhuwiex għoli (TMP 50, SMX 60), iżda l-proposta totali tal-MAH tista' tiġi aċċettata.
English: Plasma elimination of both TMP and suphamethoxazole in broilers is more rapid than in pigs (TMP t½: <1 h in broilers vs 2.5 h in pigs; SMX t½: 1.7 h in broilers vs 2.3 h in pigs).
Maltese: Eliminazzjoni mill-plażma kemm ta' TMP u kemm ta' suphamethoxazole fil-brojlers hija aktar rapida milli fil-ħnieżer (TMP t½: <1 h fil-brojlers vs 2.5 h fil-ħnieżer; SMX t½: 1.7 h fil-brojlers vs 2.3 h fil-ħnieżer).
English: Oral, via the drinking water Pigs: 2.5-5 mg trimethoprim and 12.5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days
Maltese: Orali, permezz ta' l-ilma tax-xorb Ħnieżer 2.5-5 mg trimethoprim u 12.5-25mg sulfamethoxasole għal kull kilo ta' piż tal-ġisem kull jum għal bejn 3-5 ijiem Tiġieġ: 5-12 mg trimethoprim u 2558 mg sulfamethoxasole għal kull kilo ta' piż tal-ġisem kull jum għal bejn 3-5 ijiem
English: A GLP study on pharmacokinetics following water medication of 35 mg TMP/SMX per kg per day was carried out.
Maltese: Sar studju GLP fuq il-farmakokinetika wara medikazzjoni bl-ilma ta' 35 mg TMP/SMX kull kg kuljum.
English: The Marketing Authorisation Holder has proposed a new harmonised SPC.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ippropona SPC armonizzata ġdida.
English: Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae.
Maltese: Infezzjonijiet fis-sistema respiratorja kkawżati minn Pasteurella multocida, Antinobacillus pleuropneumonaie.
English: and Pasteurella spp.
Maltese: Salmonella spp.
English: Handelsweg 25, P.O.Box 179, 5530 AD Bladel, The Netherlands
Maltese: Handelsweg 25, P.O. Box 179, 5530 AD Bladel L-Olanda
English: Infections of the urinary system caused by Escherichia coli.
Maltese: Infezzjonijiet tas-sistema urinarja kkawżati minn Escherichia coli.
English: PHARMACEUTICAL FORM Oral solution.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzjoni orali
English: PHARMACEUTICAL FORM Solution for oral administration.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzjoni għall-amministrazzjoni orali.
English: Excipients:
Maltese: Ingredjenti:
English: Methoxasol-T was authorised through a national procedure in the Netherlands in 1999 but a marketing authorisation was refused in Germany in 2001.
Maltese: Methoxasol-T kien awtorizzat permezz ta' proċedura nazzjonali fl-Olanda fl-1999 iżda awtorizzazzjoni għat-tqegħid fis-suq kienet irrifjutata fil-Ġermanja fl-2001.
English: MethoxasolLösung für Schweine und Hühner
Maltese: MethoxasolLösung für Schweine und Hühner (Soluzzjonijiet għall-Ħnieżer u t-Tiġieġ)
English: Consequently, the proposed withdrawal of 6 days in broilers is on the safe side.
Maltese: Konsegwentement, l-irtirar propost ta' 6 ijiem filbrojlers huwa fis-sikur.
English: Holder
Maltese: ISEM
English: Urogenital infections caused by Escherichia coli
Maltese: Infezzjonijiet uroġenitali kkawżati minn Escherichia coli
English: The MAH proposed a withdrawal period of 5 days in pigs and 6 days in broilers.
Maltese: Il-MAH ippropona perijodu ta' irtirar ta' 5 ijiem fil-ħnieżer u 6 ijiem fil-brojlers.
English: Do not combine with other veterinary medicinal products.
Maltese: Tikkombinax ma' prodotti veterinarji mediċinali oħra.
English: The CVMP has assessed an experimental study on clinical efficacy of Methoxasol-T for treatment of a respiratory infection caused by E.coli in chickens, as well as bibliographic and pharmacovigilance data provided by the marketing authorisation holder.
Maltese: Is-CVMP ivvaluta studju esperimentali fuq l-effikaċja klinika ta' Methoxasol-T għall-kura ta' infezzjoni respiratorja ikkaġunata minn E.coli fit-tiġieġ, kif ukoll dejta biblijografika u ta' farmakoviġilanza ipprovduta mid-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq.
English: On the basis of further additional MIC data from various publications (including two 2004 published papers showing susceptibility of various isolates from pig respiratory samples from Denmark) and from resistance monitoring by the BVL in Germany in 2006, the CVMP can accept the proposed revision of the indication:
Maltese: Fuq il-bażi ta' aktar dejta MIC addizzjonali minn pubblikazzjonijiet diversi (inklużi żewġ karti ippubblikati fl-2004 li juru s-suxxettibbiltà ta' diversi iżolati minn kampjuni respiratorji tal-ħnieżer fid-Danimarka) u minn sorveljanza ta' reżistenza mill-BVL fil-Ġermanja fl-2006, is-CVMP ma jistax jaċċetta r-reviżjoni proposta ta' l-indikazzjoni:
English: The withdrawal period for Methoxasol-T varied between EU countries, pigs 3-5 days and non-laying hens 610 days.
Maltese: Il-perijodu ta' irtirar għal Methoxasol-T varja bejn pajjiżi ta' l-UE, ħnieżer 3-5 ijiem u tiġieġ li ma jbiedux 6-10 ijiem.
English: The data show that skin was a marker tissue and sulfamethoxazole the marker residue.
Maltese: Id-dejta turi li l-ġilda kienet marker tat-tessuti u sulfamethoxazole l-marker tar-residwu.
English: P.O.
Maltese: b.
English: Hungary and Lithuania
Maltese: L-Ungerija u l-Litwanja
English: In vitro trimethoprim is generally bacteriostatic and has a broad spectrum of activity against both grampositive and gram-negative bacteria.
Maltese: In vitro t-trimethoprim huwa ġeneralment batteriostatiku u għansu spetru wiesa' ta' attività kontra kemm il-batterja tal-gram-posittiv kif ukoll tal-gram-negattiv.
English: Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1,000 kg of body weight per day.
Maltese: Tjur: 33 mg ta' kompost ta' ingredjent attiv għal kull kilogramma ta' piż tal-ġisem jew 275 ml talmediċina għal kull 1,000 kilo ta' piż tal-ġisem kull jum.
English: Resistance against potentiated sulphonamides may vary.
Maltese: Reżistenza kontra sulfonamidi potenzjati tista' tvarja.
English: Sulfamethoxazole is a broadspectrum antimicrobial agent belonging to the sulfonamides.
Maltese: Is-sulfamethoxazole huwa aġent antimikrobijal bis-spettru wiesa' li jagħmel parti mis-sulfonamides.
English: Pigs:20.8 mg sulfamethoxasole + 4.2 mg trimethoprim per kg body weight per day for 3-4 days.
Maltese: Ħnieżer20.8mg sulfamethoxasole + 4.2mg trimethoprim għal kull kilogramm ta' piż tal-ġisem kull jum għal bejn 3-4 ijiem.
English: Non-egg-laying chickens:
Maltese: Il-ħnieżer:
English: Based on these studies a 36 months shelf life for Methoxasol-T is claimed.
Maltese: Abbażi ta' dawn l-istudji, perjodi ta' ħażna ta' 36 xahar huwa affermat għal Methoxasol-T.
English: The CVMP has assessed a pilot study, a main experimental study, 2 field trial reports as well as other efficacy, pharmacokinetics and tolerance data submitted by the marketing authorisation holder.
Maltese: Is-CVMP ivvaluta studju pilota, studju esperimentali ewlieni, 2 rapporti ta' provi tal-kamp kif ukoll dejta oħra ta' effikaċja, farmakokinetika u tolleranza sottomessi mid-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq.
English: Efficacy in broilers
Maltese: Ħnieżer u brojlerijiet
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol-T oral solution for pigs and broilers
Maltese: VETERINARJU Methoxasol-T soluzjoni orali għall-ħnieżer u brojlerijiet
English: Solubility and stability of Methoxasol-T in drinking water are pH-dependent.
Maltese: Is-solubilità u s-stabilità tal-Methoxasol-T fl-ilma tax-xorb huma dipendenti fuq il-pH.
English: METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: The results of the in-use stability testing of the product after 15 months storage at 25°C/60% RH and in-use of 12 months after opening showed acceptable stability.
Maltese: Ir-riżultati ta' l-ittestjar ta' l-istabbilità waqt l-użu wara ħażna ta' 15-il xahar f'25°C/60% RH u waqt lużu ta' 12-il xahar wara li jiġi miftuħ urew stabbilità aċċettabbli.
English: Hens:
Maltese: Biss.
English: Pigs: 24 mg/kg b.w., equivalent to 1 litre of the drug in 500 L drinking water, for 3-4 days Hens: 33 mg/kg b.w., equivalent to 1 litre of the drug in 750 L drinking water, for 3-4 days
Maltese: Ħnieżer: 24mg/kilogramm ta' piż tal-ġisem, ekwivalenti għal litru ta' mediċina f'500 litru ilma tax-xorb, għal bejn 3 u 4 ijiem Tiġieġ: 33 mg/kilogramm ta' piż talġisem, ekwivalenti għal litru ta' mediċina f'750 litru ilma tax-xorb, għal bejn 3 u 4 ijiem
English: In the event of accidental ingestion, seek medical advice.
Maltese: Għandu jingħata biss bi preskrizzjoni medika.
English: During preparation and administration of the medicated drinking water, skin contact with the drug should be avoided.
Maltese: Waqt il-preparament u l-amministrazzjoni tal-ilma tax-xorb medikat, il-kuntatt mal-ġilda bid-droga għandu jiġi evitat.
English: Broilers: 33 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 750 L drinking water, for 3-4 days.
Maltese: Il-brojlerijiet: 33mg/kg toqol tal-ġisem, li jikkorrispondi għal bejn wieħed u ieħor 1 litru tad-droga f'750 L ta' ilma tax-xorb, għal 3-4 ijiem.
English: Bronchial infections caused by Escherichia coli, Salmonella spp.
Maltese: Infezzjonijiet fil-bronki kkawżati minn Escherichia coli Salmonella spp u Pasteurella spp.
English: For the treatment of respiratory tract infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers).
Maltese: Għat-trattament ta' infezzjonijiet fissistema respiratorja, infezzjonijiet filġilda, gastrointestinali u uroġenitali kkawżati minn patoġeni li huma sensittivi għal trimethoprim u sulfamethoxasole fil-ħnieżer u t-tjur (imkabbra għal-laħam).
English: Bronchial infections caused by Pasteurella multocida.
Maltese: Salmonella spp., Pasteurella multocida.
English: The Cmax of sulfamethoxazole in chickens is approximately 9.0 µg/g, whereas that of trimethoprim is 0.12 µg/g.
Maltese: Is-Cmax tas-sulfamethoxazole fit-tiġieġ hija bejn wieħed u ieħor 9.0 µg/g, mentri dik taltrimethoprim hija ta' 0.
English: ATC vet classification (of the combination): QJ01E W
Maltese: Il-klassifikazzjoni tal-ATC vet (tal-kombinazzjoni):
English: Infections of the digestive system caused by Salmonella spp.
Maltese: Infezzjonijiet fis-sistema diġestiva kkawżati minn Salmonella spp.
English: Pigs: 24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1,000 kg of body weight per day.
Maltese: Ħnieżer: 24 mg ta' kompost ta' ingredjent attiv għal kull kilogramm ta' piż tal-ġisem jew 200 ml talmediċina għal kull 1,000 kilo ta' piż tal-ġisem kull jum.
English: Interactions Do not combine with other veterinary medicinal products.
Maltese: Effetti fuq prodotti mediċinali oħra Tikkombinax ma' prodotti veterinarji mediċinali oħra.
English: The Cmax of sulfamethoxazole in pigs is approximately 6.2 µg/g.
Maltese: Is-Cmax tas-sulfamethoxazole fil-ħnieżer hija bejn wieħed u iehor 6.2 µg/g.
English: In an old study in broilers with a dose of 38.5mg /kg bwt depletion in skin and plasma demonstrated that the residues were below the MRL by 4 days.
Maltese: Fi studju antik fil-brojlers b'doża ta' 38.5mg /kg piż tal-ġisem (bwt) fil-ġilda u fil-plażma wera li rreżidwi kienu taħt l-MRL sa 4 ijiem.
English: The CVMP accepts that a claim for efficacy at a dose of 25mg/kg for 4 days for the treatment of respiratory infections in pigs has been demonstrated.
Maltese: Is-CVMP aċċetta li intweriet affermazzjoni għal effikaċja f'doża ta' 25mg/kg għal 4 ijiem għattrattament ta' infezzjonijiet respiratorji fil-ħnieżer.
English: For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole.
Maltese: Għat-trattament ta' infezzjonijijet ikkawżati minn organiżmi li jkunu sensittivi għall-kombinazzjoni ta' trimethoprim u sulfamethoxasole.
English: Box 179 5530 AD Bladel The Netherlands
Maltese: Handelswegg 25, PO Box 179, 5530 AD Bladel, The Netherlands
English: In respect of the benefit/risk balance for target species poultry, the CVMP concludes that:
Maltese: Fir-rigward tal-bilanċ tar-riskju/benefiċċju għall-ispeċi ta' tjur fil-mira, is-CVMP ikkonkluda:
English: Broilers:27.5 mg sulfamethoxasole + 5.5 mg trimethoprim per kg body weight per day for 3-4 days.
Maltese: Tiġieġ imkabbar għal-laħam27.5 mg sulfamethoxasole + 5.5 mg trimethoprim għal kull kilogramm ta' piż tal-ġisem kull jum għal bejn 3-4 ijiem.
English: The CVMP recommends the following changes to the SPC proposed by the MAH:
Maltese: Is-CVMP jirrikmanda t-tibdil li ġej fl-SPC propost mill-MAH:
English: The dossier sent to Germany including the answers to the list of questions and to Poland, Hungary and Lithuania was almost the same, but with additional experimental clinical studies.
Maltese: Id-dossier mibgħut lill-Ġermanja inklużi ttweġibiet għal-lista ta' mistoqsijiet u lill-Polonja, l-Ungerija u l-Litwanja kienu kważi l-istess, iżda bi studji kliniċi esperimentali addizzjonali.
English: A synergistic and bactericidal effect occurs when trimethoprim is combined with sulfamethoxazole, because trimethoprim and sulfamethoxazole inhibit sequential steps in the synthesis of tetrahydrofolic acid, an essential metabolic cofactor in bacterial synthesis of purine and, subsequently, DNA.
Maltese: Effett sinerġistiku u batterocidiku jseħħ meta t-trimethoprim huwa kombinat mas-sulfamethoxazole, peress li t-trimethoprim u ssulfamethoxazole jżommu lura passi wara xulxin fis-sinteżi tal-aċidu tetrahidrofoliku, kofattur essenzjali metaboliku fis-sintesi batterika tal-purine u, sussegwentament, id-DNA.
English: • notwithstanding the fact that a definitive clinical field study using the recommended dosage of the product has not been provided, taking into account the pre-clinical studies, the artificial infection model, the history of use and the other pertinent information provided, the various risk management steps now set out in the proposed SPC and noting the fact that the indications for use are restricted, the benefit / risk balance is positive;
Maltese: • minkejja l-fatt li studju kliniku definittiv bl-użu tad-dożaġġ irrikmandat tal-prodott ma ġiex ipprovdut, filwaqt li ġew ikkunsidarti l-istudji ta' qabel l-użu kliniku, il-mudell ta' infezzjoni artifiċjali, l-istorja ta' l-użu u tagħrif ieħor pertinenti ipprovdut, id-diversi passi ta' maniġment ta' riskju maħruġa issa fl-SPC proposta u bl-osservanza tal-fatt li l-indikazzjonijiet għall-użu huma limitati, il-bilanċ benefiċċju/riskju huwa wieħed pożittiv;
English: • the availability of an authorised veterinary medicinal product containing active substances other than fluoroquinolones might be regarded an indirect benefit and not directly relevant to the scope of this referral procedure (as efficacy must be shown for each product independently);
Maltese: • id-disponibbiltà ta' prodott mediċinali veterinarju awtorizzat li fih sustanzi attivi għajr fluoroquinolones (florokwinoloni) tista' tiġi ikkunsidrata benefiċċju indirett u mhux direttament relevanti għall-iskop ta' din il-proċedura ta' referenza (peress li l-effikaċja trid tintwera għal kull prodott b'mod indipendenti);
English: The Netherlands Eurovet Animal Health
Maltese: L-Olanda Eurovet Animal Health
English: As to where the SPC´s in The Netherlands, Austria and Poland, Methoxasol-T include indications that cover urogenital, gastrointestinal and skin infections, CVMP concludes that no data have been provided supporting these claims.
Maltese: Fir-rigward ta' fejn l-SPC's fl-Olanda, l-Awstrija u l-Polonja, (Methoxasol-T) inkludew indikazzjonijiet li jkopru infezzjonijiet uroġenitali, gastrointestinali u tal-ġilda, is-CVMP ikkonkluda li l-ebda dejta ma ġiet ipprovduta li twieżen dawn l-affermazzjonijiet.
English: In chicken an acute overdose will not occur because the birds will be reluctant to drink the strongly concentrated drinking water (too bitter taste if above 2 litres Methoxasol-T per 1000 litre drinking water).
Maltese: Fit-tiġieġ dosaġġ akuta mhix ser tiġri peress li l-agħsafar ma jkunux iridu jixorbu l-ilma b'konċentrament qawwija (togħma qarsa ħafna jekk iżjed minn 2 litri ta' Methoxasol-T kull 1000 liru ta' ilma tax-xorb).
English: Poland
Maltese: Stat Membru
English: The 1000 ml bottle is closed with a tamper-proof LDPE screw-cap.
Maltese: Il-flixkun tal-1000 ml huwa magħluq b'tap bil-kamin LDPE mhux mbagħbas.
English: MARKETING AUTHORISATION HOLDER Eurovet Animal Health B.V.
Maltese: Il-Ġermanja Eurovet Animal Health
English: Broilers: Treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Maltese: Trattament u prevenzjoni ta' infezzjonijiet respiratorji kkawżati minn Escherichia coli suxxettibbli għat-trimethoprim u s-sulfamethoxazole fejn il-marda instabet fil-merħla.
English: Austria received a dossier similar to the original sent to Germany.
Maltese: L-Awstrija irċeviet dossier simili għal dak oriġinali mibgħut lill-Ġermanja.
English: Pigs and broilers.
Maltese: Ħnieżer