FrancophonIA/ELRC3.0 huggingface dataset:
English: No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
Maltese: Fertilità Ma ġie osservat l-ebda indeboliment fil-fertilità fi studju tat-tossiċità fil-fertilità u fir-riproduzzjoni ġenerali fil-ġrieden li saru b'antikorp analogu li jinibixxi IL-5 fil-ġrieden.
English: Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Maltese: 3. Agħti l-injezzjoni ta' 0.4 mL (ekwivalenti għal 40 mg mepolizumab) taħt il-ġilda fil-parti ta' fuq tad driegħ, il-koxxa jew l-addome.
English: How to store Nucala
Maltese: Qabel tuża Nucala
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TISTA' TINQARA MILL-BNIEDEM
English: Odds ratio (95% CI) p-value
Maltese: Proporzjon tarrata (95% CI) valur-p
English: In patients with severe refractory eosinophilic asthma (adults/adolescents), following a dose of 100 mg administered subcutaneously every 4 weeks for 32 weeks, blood eosinophils were reduced from a geometric mean count at baseline of 290 to 40 cells/µL at week 32 (n=182), a reduction of 84% compared to placebo.
Maltese: F'pazjenti b'ażżma esinofilika refrattorja (adulti/adoloxxenti), wara doża ta' 100 mg mogħtija taħt il-ġilda kull 4 ġimgħat għal 32 ġimgħa, l-esinofili tad-demm tnaqqsu minn medja ġeometrika f'linja bażi ta' 290 għal 40 ċellola/µL fil-ġimgħa 32 (n=182), tnaqqis ta' 84% meta mqabbel ma' plaċebo.
English: Mepolizumab 100 mg (subcutaneous) N= 194
Maltese: Mepolizumab 100 mg
English: Table 3: Combined analysis of the rate of clinically significant exacerbations by baseline blood eosinophil count in patients with severe refractory eosinophilic asthma
Maltese: Tabella 3: Analiżi kombinata tar-rata ta' taħrix klinikament sinifikanti skont l-għadd ta' esinofili fiddemm fil-linja bażi f'pazjenti b'ażżma esinofilika refrattorja severa
English: For the oral corticosteroid-sparing study MEA115575, a total of 135 patients were enrolled (55% were female; mean age of 50 years) who were being treated daily with OCS (5-35 mg per day), and high-dose ICS plus an additional maintenance medicine.
Maltese: (55% kienu nisa; età medja ta' 50 sena) li kienu qegħdin jiġu trattati kuljum b'OCS (5-35 mg kuljum), u ICS
English: Investigation of a 40 mg subcutaneous dosing regimen administered every 4 weeks in children 6 to 11 years old over a 15-70 kg broad weight range by PK modelling and simulation predicts that the exposure of this dosing regimen would remain on average within 38% of adults at 100 mg.
Maltese: 6 u 11-il sena fuq medda wiesgħa tal-piż ta' 15-70 kg permezz ta' mudellar u simulazzjoni PK tipprevedi li lesponiment ta' dan il-kors tad-dożaġġ jibqa' bħala medja fit-38% ta' adulti b'100 mg.
English: If you may have had a similar reaction to any injection or medicine:
Maltese: Jekk seta' kellek xi reazzjoni simili għal xi injezzjoni jew mediċina:
English: • pharyngitis (sore throat) • nasal congestion (stuffy nose)
Maltese: • Reazzjonijiet allerġiċi severi (anafilassi)
English: Needle guard
Maltese: Pazjenti anzjani
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e. essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) għal kull doża ta' 100 mg, jiġifieri huwa essenzjalment “mingħajr sodium”.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Maltese: Mill-punt mikrobijoloġiku, sakemm il-metodu ta' rikostituzzjoni jipprekludi r-riskju ta' kontaminazzjoni mikrobjali, il-prodott għandu jintuża immedjatament.
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80.
Maltese: Is-sustanzi l-oħra huma sucrose, sodium phosphate dibasic heptahydrate u polysorbate 80.
English: The recommended dose for adults and adolescents is 100 mg. You will be given 1 injection every four weeks.
Maltese: Id-doża rakkomandata għall-adulti u l-adoloxxenti hi 100 mg.
English: Each 1 ml pre-filled syringe contains 100 mg mepolizumab.
Maltese: Kull kunjett fih 100 mg mepolizumab.
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma following either 40 mg subcutaneously (for a weight < 40kg) or 100 mg subcutaneously (for a weight ≥ 40 kg), 2/35 (6%) had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab during the initial short phase of the study.
Maltese: Fi tfal ta' bejn 6 u 11-il sena b'ażżma esinofilika refrattorja severa li kienu qed isegwu jew 40 mg taħt ilġilda (għal piż ta' < 40kg) jew 100 mg taħt il-ġilda (għal piż ta' ≥ 40 kg), 2/35 (6%) kellhom antikorpi antimepolizumab li setgħu jinstabu wara li rċevew tal-anqas doża waħda ta' mepolizumab waqt il-fażi qasira inizjali tal-istudju.
English: A total of 896 adults and 19 adolescent subjects with severe refractory eosinophilic asthma received either a subcutaneous or an intravenous dose of mepolizumab during three placebo-controlled clinical studies of 24 to 52 weeks duration.
Maltese: Total ta' 896 adult u 19-il adoloxxent individwu b'ażżma esinofilika refrattorja severa irċevew jew doża taħt il-ġilda jew ġol-vina ta' mepolizumab matul tliet studji kliniċi kkontrollati bi plaċebo li damu 24 sa 52
English: respectively.
Maltese: Sentejn.
English: Paediatric pharmacokinetics following subcutaneous administration in subjects 6 to 11 years old with severe refractory eosinophilic asthma was investigated in an open label, uncontrolled study of 12-weeks duration.
Maltese: Il-farmakokinetika pedjatrika wara amministrazzjoni taħt il-ġilda f'individwi ta' bejn 6 u 11-il sena b'ażżma esinofilika refrattorja severa ġiet investigata fi studju bit-tikketta mikxufa, mhux ikkontrollat ta' 12-il ġimgħa.
English: Renal and hepatic impairment No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament għal pazjenti b'indeboliment renali jew epatiku (ara sezzjoni 5.2).
English: In 2 placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively.
Maltese: 100 mg mogħti taħt il-ġilda u plaċebo kienet ta' 8 % u 3 %, rispettivament.
English: For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
Maltese: Biex jingħata taħt il-ġilda, preferibbilment għandha tintuża siringa tal-polypropylene ta' 1 ml b'labra li tintrema ta' kejl 21 sa 27 x 0.5 pulzieri (13 mm).
English: After a treatment interruption of 8 weeks, 30 of these patients, received mepolizumab for a further 52 weeks.
Maltese: Wara interruzzjoni fit-trattament ta' 8 ġimgħat, 30 minn dawn il-pazjenti, irċivew mepolizumab għal 52 ġimgħa oħra.
English: Clear, colourless 10 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a plastic flip-cap containing 100 mg powder for solution for injection.
Maltese: Kunjett tal-ħġieġ tat-tip I ta' 10 ml , trasparenti, bla kulur, b'tapp tal-gomma bromobutyl u b'siġill tal aluminju griż b'tapp tal-plastik li tifflippjah biex tiftħu li fih100 mg trab għal soluzzjoni għal injezzjoni.
English: • Continue to hold the pen in place while you count to 5.
Maltese: • Kompli żomm il-pinna f'postha waqt li tgħodd sa 5.
English: Also contains: sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Maltese: Fih ukoll: sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, ilma għall-injezzjonijiet.
English: ITT Population Mepolizumab 100 mg (subcutaneous) N= 69
Maltese: Popolazzjoni ITT Mepolizumab 100 mg
English: Also contains: sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections
Maltese: Fiha wkoll: sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, ilma għall-injezzjonijiet
English: • Continue to hold the pen down until you hear the 2nd “click”, and the stopper and yellow indicator have stopped moving and fill the inspection window.
Maltese: • Kompli żomm il-pinna 'l isfel sakemm tisma' t-2ni “klikk”, u t-tapp u l-indikatur l-isfar ikunu waqfu jiċċaqilqu u jimlew it-tieqa ta' spezzjoni.
English: As a precautionary measure, it is preferable to avoid the use of Nucala during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, huwa preferibbli li jiġi evitat l-użu ta' Nucala waqt it-tqala.
English: Inspection window (medicine
Maltese: IL-PRODOTT MEDIĊINALI
English: There are no fertility data in humans.
Maltese: Human Genome Sciences, Inc.
English: • urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
Maltese: • infezzjoni fl-apparat tal-awrina (demm fl-awrina, awrina frekwenti u bl-uġigħ, deni, uġigħ fil-parti t'isfel tad-dahar)
English: Eosinophils are thought to be associated with immune system responses to some parasitic infections.
Maltese: Infezzjonijiet parassitiċi Nucala jista' jdgħajjef ir-reżistenza tiegħek għal infezzjonijiet ikkawżati minn parassiti.
English: Median % reduction in daily OCS dose from baseline (95% CI) Median difference (95% CI) p-value
Maltese: Proporzjon ta' probabbiltà (95% CI) valur-p % Medjan ta' tnaqqis fid-doża ta' kuljum ta' OCS mil-linja bażi (95% CI)
English: Nucala is available in a pack containing 1 pre-filled pen, or in a multipack comprised of 3 x 1 pre-filled pen.
Maltese: Nucala hu disponibbli f'pakkett li fih kunjett wieħed jew f'pakketti multipli bi 3 kunjetti individwali.
English: Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Maltese: 3. Agħti l-injezzjoni ta' 1mL (ekwivalenti għal 100 mg mepolizumab) taħt il-ġilda fil-parti ta' fuq tad driegħ, il-koxxa jew l-addome.
English: Severe refractory eosinophilic asthma
Maltese: Injetta lilek innifsek fil-koxox jew fl-addome
English: As mepolizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Maltese: Billi mepolizumab hu antikorp monoklonali, ma sar l-ebda studju tal-ġenotossiċità jew tal-karcinogeniċità.
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Maltese: Is-sustanzi l-oħra huma sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, ilma għall-injezzjonijiet.
English: Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Maltese: Adulti u adoloxxenti li għandhom 12-il sena u aktar Id-doża rakkomandata ta' mepolizumab hi 100 mg mogħtija taħt il-ġilda darba kull 4 ġimgħat.
English: Exp: Month-Year
Maltese: fuq tad-driegħ tiegħek
English: Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma.
Maltese: Nucala hu indikat bħala trattament supplimentali għal ażżma esinofilika refrattorja severa f' adulti,
English: 1 pre-filled syringe
Maltese: TAL-PRODOTT MEDIĊINALI
English: Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull doża ta' 100 mg, jiġifieri hija essenzjalment “mingħajr sodium”.
English: Powder for solution for injection.
Maltese: Trab għal soluzzjoni għal injezzjoni.
English: Nucala is available in a pack containing 1 pre-filled syringe or in multipacks comprised of 3 x 1 pre-filled syringes.
Maltese: Nucala hu disponibbli f'pakkett li fih pinna mimlija għal-lest waħda, jew f'pakkett multiplu li fih 3 x 1 pinna mimlija għal-lest.
English: This magnitude of blood eosinophils reduction was maintained in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies.
Maltese: Dan id-daqs ta' tnaqqis flesinofili tad-demm inżamm f'pazjenti b'ażżma esinofilika refrattorja severa (n=998) ittrattati għal medjan ta' 2.8 snin (medda 4 ġimgħat sa 4.5 snin) fi studji ta' estensjoni miftuħa.
English: Percent reduction Rate ratio (95% CI) p-value
Maltese: Proporzjon tar-rata (95% CI)
English: (<1/10,000); and not known (cannot be estimated from available data).
Maltese: (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The stream of sterile water should be directed vertically, onto the centre of the lyophilised cake.
Maltese: Il-fluss ta' ilma sterili għandu jkun direzzjonat b'mod vertikali fuq iċ-ċentru tal-kejk lajofilizzat.
English: Skin and subcutaneous tissue disorders
Maltese: Protezzjoni tal-labra safra
English: Once reconstituted, Nucala will contain a concentration of 100 mg/mL mepolizumab.
Maltese: Ladarba jkun rikostitwit, Nucala jkun fih konċentrazzjoni ta' 100 mg/mL mepolizumab.
English: Following a single intravenous administration to patients with asthma, the mean systemic clearance (CL) ranged from 1.9 to 3.3 mL/day/kg, with a mean terminal half-life of approximately 20 days.
Maltese: 3.3 mL/kuljum/kg, b'half-life terminali medja ta' bejn wieħed u ieħor 20 ġurnata.
English: Following a single intravenous administration to patients with asthma, mepolizumab distributes into a mean volume of distribution of 55 to 85 mL/kg.
Maltese: distribuzzjoni ta' 55 sa 85 mL/kg.
English: Eczema
Maltese: Kunjett
English: Clear needle cap
Maltese: Jekk qed tredda',
English: Lyophilised white powder.
Maltese: • Aħsel idejk bis-sapun u bl-ilma.
English: Store syringe in the original carton in order to protect from light.
Maltese: Aħżen fil-kartuna oriġinali biex tipproteġġih mid-dawl.
English: to 3 ml syringe and a 21 gauge needle.
Maltese: Siringa 1 mimlija għal-lest
English: Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1).
Maltese: adoloxxenti u tfal li għandhom 6 snin jew aktar (ara sezzjoni 5.1).
English: White plunge
Maltese: Bijotrasformazzjoni
English: • nasal congestion (stuffy nose)
Maltese: • reazzjonijiet allerġiċi severi (anafilassi)
English: Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Maltese: Tfal li għandhom bejn 6 u 11-il sena Id-doża rakkomandata hi 40 mg.
English: Asthma exacerabations
Maltese: Reazzjonijiet allerġiċi
English: • Nucala pre-filled syringe
Maltese: Agħfas 'l isfel
English: Multipack comprising 3 (3 packs of 1) pre-filled syringe
Maltese: Pakkett multiplu li fih 3 (3 pakketti ta'1) pinen mimlijin għal-lest
English: {text}
Maltese: {test}
English: Annex <III> <IV>
Maltese: Anness <III> <IV>
English: <Annex III>
Maltese: III>
English: To the extent that additional medicinal products containing {active substance(s) as EURD list entry} are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
Maltese: Sa fejn il-prodotti mediċinali addizzjonali li fihom {sustanza/sustanzi attiva/attivi skont id-daħla fil-lista tal-EURD} huma awtorizzati attwalment fl-UE jew huma suġġetti għal proċeduri ta' awtorizzazzjoni futuri fl-UE, is-CMDh jirrakkomanda li l-Istati Membri kkonċernati u l-applikant /d-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq iqisu kif jixraq din il-pożizzjoni tas-CMDh.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {active substance(s) as EURD list entry}, the scientific conclusions are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal {sustanza/sustanzi attiva/attivi skont id-daħla fil-lista tal-EURD}, il-konklużjonijiet xjentifiċi huma kif ġej:
English: <Package Leaflet>
Maltese: <Sommarju tal-Karatteristiċi tal-Prodott>
English: Adoption of CMDh position: {Month Year} CMDh meeting
Maltese: <Fuljett ta' Tagħrif>
English: On the basis of the scientific conclusions for {active substance(s) as EURD list entry} the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing {active substance(s) as EURD list entry} is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għal {sustanza/sustanzi attiva/attivi skont id-daħla fil-lista tal-EURD} is-CMDh huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodott(i) mediċinali li fih/fihom {sustanza/sustanzi attiva/attivi skont id-daħla fil-lista tal-EURD} mhuwiex mibdul suġġett għall-bidliet proposti għall-informazzjoni tal-prodott.
English: Transmission to National Competent Authorities of the translations of the annexes to the position: {DD/MM/YYYY}
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għall-pożizzjoni:
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): {DD/MM/YYYY}
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri (sottomissjoni tal-varjazzjoni mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq):
English: <Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)>
Maltese: <Emendi li għandhom ikunu inklużi fis-sezzjonijiet rilevanti tal-Informazzjoni dwar il-Prodott (test ġdid sottolinjati u b'tipa grassa, it-test imħassar huwa ingassat)>
English: 8000 units (40 mg)
Maltese: 8000 unità (40 mg)
English: 10000 units (50 mg)/10 ml; 10 ml (1000
Maltese: 10000 unità (50 mg)/10 ml; 10 ml (1000
English: 8000 units (40 mg)/8 ml; 8 ml (1000 U/ml5 mg/ml)
Maltese: 8000 unità (40 mg)/8 ml; 8 ml (1000 U/ml5 mg/ml)
English: 10000 units (50 mg) Powder and solvent for solution for injection
Maltese: 10000 unità (50 mg) Trab u solvent għal soluzzjoni għall-injezzjoni
English: Bovine 200
Maltese: Bovin 200
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE
Maltese: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANZA
English: Meloxicam Meloxicam Bovine 20
Maltese: Meloxicam Meloxicam Bovin 20
English: Dimethyl sulfoxide Glycerol formal, stabilised
Maltese: Dimethyl sulfoxide Glycerol formal, stabilizzat
English: ATCvet code: QJ01BA99.
Maltese: Kodici ATĊ veterinarja: QJ01BA99
English: Date of first authorisation: 15/05/2017.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15/05/2017.
English: Pharmacotherapeutic group: Antibacterials for systemic use, amphenicols, combinations.
Maltese: Antibatteriċi għal użu sistemiiku, amphenicols, kombinazzjonijiet.
English: Translucent multi-layered plastic vials (polypropylene/ethylene vinyl alcohol/polypropylene) with chlorobutyl rubber stoppers and aluminium and plastic flip capsules, containing 50 ml, 100 ml or 250 ml.
Maltese: Kunjetti tal-plastik ta' diversi saffi transluċenti (polypropylene/ethylene vinyl alcohol/polypropylene) b'tappijiet tal-lastku tal-chlorobutyl u aluminju kapsuli li jinqalgħu f'saba' tal-plastik, li fihom 50 ml, 100 ml jew 250 ml.
English: The active substances in Zeleris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanzi attivi f'Zeleris huma sustanzi permessi kif deskritti f'tabella 1 tal-anness tar-Regolament tal-Kummissjoni(UE) Nru 37/2010:
English: Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram-positive and Gramnegative bacteria isolated from domestic animals.
Maltese: Florfenicol huwa antibijotiku sintetiku ta' spettru wiesa' effettiv kontra batteriċi Gram-pożittivi u Gram-negattivi iżolati minn annimali domestiċi.
English: Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).
Maltese: Leżjonijiet intestinali makroskopiċi kienu osservati fl-awtopsja (preżenza ta' fibrin, ulċeri abomasali, punti emorraġiċi u tħaxxin tassuperfiċji abomasali)
English: EU/2/17/210/002 EU/2/17/210/003
Maltese: EU/2/17/210/003
English: For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following breakpoints have been determined by CLSI (Clinical and Laboratory Standards institute) for bovine respiratory pathogens: susceptible ≤ 2 µg/ml, intermediate: 4 µg/ml, resistant: ≥ 8 µg/ml.
Maltese: Għal Mannheimia haemolytica, Pasteurella multocida u Histophilus somni il-punti ta' sfondament li ġejjin ġew stabbiliti minn CLSI (Clinical and Laboratory Standards Institute) għal patoġeni respiratorji tal-ifrat: suxxetibbli ≤ 2µg/ml, intermedjarju: 4 µg/ml, reżistenti: ≥ 8 µg/ml.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: Il-frekwenza ta' reazzjonijiet avversi hi mfissra permezz tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn annimal 1 f'10 trattat juri reazzjoni(jiet) avvers(a/i)) - komuni (aktar minn annimal 1 imma inqas minn 10 f'100 annimal trattat) - mhux komuni (aktar minn annimal 1 imma inqas minn 10 f'1,000 annimal trattat) - rari (aktar minn annimal 1 imma inqas minn 10 f'10,000 annimal trattat) - rari ħafna (inqas minn annimal 1 f'10,000 annimal trattat, li jinkludu rapporti iżolati)
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.
Maltese: Għal Mannheimia haemolytica, Pasteurella multocida u Histophilus somni il-punti ta' sfondament ta'
English: For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times.
Maltese: Għall-kunjetti ta' 250 ml, it-tapp tal-lastku jista' jiġi mtaqqab sa 20 darba.
English: Cardboard box with 1 vial of 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 50 ml, 100 ml jew 250 ml.
English: Meloxicam is extensively bound to plasma proteins (97%) and is distributed in all well-perfused organs.
Maltese: Meloxicam jintrabat b'mod estensiv mal-proteini fil-plażma (97%) u huwa mifrux florgani kollha perfużi tajjeb.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Maltese: Meloxicam huwa mediċina antinfjammatorja mhux sterojdali (NSAID - non-steroidal antiinflammatory drug) tal-klassi oxicam li jaġixxi b'impediment tas-sintesi ta' prostaglandin, b'hekk jeżerċita effetti anitnfjammatorji, kontra t-tnixxija, analġeżiċi u antipiretiċi.
English: For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following florfenicol breakpoints have been determined by CLSI (Clinical and Laboratory Standards institute) for bovine respiratory pathogens: susceptible ≤ 2 µg/ml, intermediate : 4 µg/ml, resistant : ≥ 8 µg/ml.
Maltese: florfenicol li ġejjin ġew stabbiliti minn CLSI (Clinical and Laboratory Standards Institute) għal patoġeni respiratorji tal-ifrat: suxxetibbli ≤ 2µg/ml, intermedjarju: 4 µg/ml, reżistenti: ≥ 8 µg/ml.
English: The extent of these adverse effects was dose-dependent.
Maltese: Il-firxa ta' dawn l-effetti avversi kien dipendenti fuq id-doża.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont l-istima ta' benefiċċju/riskju mill-veterinarju responsabbli.