FrancophonIA/ELRC3.0 huggingface dataset:
English: Genetic and pharmacologic studies in animal models have provided evidence that PGD2, acting through DP1, one of the two receptors for PGD2, plays a key role in nicotinic acid-induced flushing.
Maltese: Studji ġenetiċi u farmakoloġiċi f'mudelli ta' l-annimali taw evidenza li l-PGD2, li jaħdem permezz tad-DP1, wieħed miż-żewġ riċetturi għall-PGD2, għandu rwol prinċipali fit-tifwir indott mill-aċidu nikotiniku.
English: Nicotinic acid inhibits release of free fatty acids (FFA) from adipose tissue, which may contribute to the reduced plasma LDL-C, TC, VLDL-C, apo B, TG, and Lp(a), as well as elevated HDL-C, and apo A-I, all of which are associated with lower cardiovascular risk.
Maltese: mit-tessut xaħmi, li jista' jikkontribwixxi għat-tnaqqis fl-LDL-C, TC, VLDL-C, apo B, TG, u Lp(a)
English: Uncommon: dyspnoea
Maltese: TWISSIJA(IET) SPEĊJALI
English: For patients switching from immediate-release nicotinic acid to Pelzont, therapy should be initiated at the 1,000 mg/20 mg dose and advanced to the 2,000 mg/40 mg maintenance dose after four weeks.
Maltese: Fil każ tal-pazjenti li jaqilbu minn aċidu nikotiniku ta' rilaxx immedjat għal Pelzont, it-terapija għandha tinbeda bid-doża ta' 1,000 mg/20 mg u tgħaddi għad-doża ta' manteniment ta' 2,000 mg/40 mg wara erba' ġimgħat.
English: The potential risk for humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali għall-bniedem.
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Pelzont declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Maltese: Fil-pazjenti li komplew fl-ewwel studju (24 ġimgħa), il-frekwenza ta' fawra moderata jew akbar f'pazjenti trattati bi Pelzont naqset jew avviċinat dik tal-pazjenti li rċevew plaċebo (ara Figura 1), filwaqt li fil-pazjenti trattati bl-aċidu nikotiniku (formulazzjoni li terħi lmediċina bil-mod) il-frekwenza tal-fwawar baqgħet kostanti (wara Ġimgħa 6).
English: Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Maltese: Effetti ta' l-aċidu nikotiniku fuq prodotti mediċinali oħra
English: The reduction in flushing symptoms (assessed by patient questionnaires) was correlated with a reduction in nicotinic acid-induced vasodilatation (assessed by measurements of skin blood flow).
Maltese: It tnaqqis fis-sintomi ta' fawra (evalwati mill-kwestjonarji fil-pazjenti) kien korrelat ma' tnaqqis fil vażodilatazzjoni indotta mill-aċidu nikotiniku (evalwata bil-kejl tal-fluss tad-demm fil-ġilda).
English: *Includes patients with moderate, severe, or extreme flushing symptoms †Dose advancement at Week 5
Maltese: *Jinkludi pazjenti b'sintomi moderati, severa, jew estremi ta' fawra
English: Flushing
Maltese: Anzjani
English: Opaque PVC/Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
Maltese: Folja opaka tal-PVC/Aclar b'għeluq ta' l-aluminju push-through li fiha 14-il pillola li jerħu l mediċina.
English: Switching from immediate-release (crystalline) nicotinic acid to Pelzont has not been studied.
Maltese: Il-qlib minn aċidu nikotiniku (kristallin) ta' rilaxx immedjat għal Pelzont ma ġiex studjat.
English: Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Maltese: Laropiprant jitneħħa prinċipalment permezz ta' acyl glucuronidation, segwita mill-eskrezzjoni talglucuronide fl-ippurgar (permezz tal-bile) u l-awrina.
English: Acetylsalicylic acid: In a clinical study, concomitant administration of laropiprant with acetylsalicylic acid did not have an effect on collagen-induced platelet aggregation or on bleeding time compared to treatment with acetylsalicylic acid alone (see section 5.1).
Maltese: Fi studju kliniku, l-għoti fl-istess ħin ta' laropiprant ma' l-acetylsalicylic acid ma kellux effett fuq l-aggregazzjoni tal-plejtlits indotta mill-collagen jew fuq il-ħin tal-fsada meta mqabbel ma' trattament bl-acetylsalicylic acid biss (ara sezzjoni 5.1).
English: In an interim analysis of an ongoing clinical outcome study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking Pelzont and simvastatin 40 mg.
Maltese: F'analiżi interim tar-riżultati kliniċi ta' studju li għadu għaddej, kumitat indipendenti ta' monitoraġġ tas-sigurtà identifika inċidenza ogħla milli mistennija ta' mijopatija f'pazjenti Ċiniżi li kienu qegħdin jieħdu Pelzont u simvastatin 40 mg.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multi-packs of 196 (2 packs of 98 modified-release tablets) - without blue box (for PVC/Aclar blister)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT LI JMISS MAL-PRODOTT Pakketti multipli ta' 196 (2 pakketti ta' 98 pillola li jerħu b'mod modifikat) - mingħajr kaxxa blu (għal folja tal-PVC/Aclar)
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Pelzont experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2,000 mg titration) (p< 0.001).
Maltese: Fit-tieni studju (16-il ġimgħa) fejn kien permess l-acetylsalicylic acid, il-pazjenti li ħadu Pelzont esperjenzaw ġranet konsiderevolment inqas fil-ġimgħa b'fawra moderata jew akbar meta mqabbel ma' l-aċidu nikotiniku (formulazzjoni li terħi l-mediċina bil-mod meħuda bħala titrazzjoni multi-step ta' 500 mg għal 2,000 mg fuq tnax-il ġimgħa)
English: Laropiprant suppresses PGD2 mediated flushing associated with administration of nicotinic acid.
Maltese: Laropiprant irażżan ilfawra medjata minn PGD2 assoċjata ma' l-għoti ta' l-aċidu nikotiniku.
English: Elevated plasma TG levels are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD).
Maltese: Livelli għoljin ta' TG fil-plażma sikwit jinstabu fi trijade ma' livelli baxxi ta' HDL-C u partikoli żgħar ta' LDL, kif ukoll flimkien ma' fatturi ta' riskju metaboliċi mhux lipidi għal mard tal-qalb koronarju (CHD).
English: • nicotinic acid, a lipid modifying medicine, and
Maltese: • aċidu nikotiniku, mediċina li timmodifika ix-xaħmijiet u
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Maltese: Kull pillola li terħi l-mediċina b'mod modifikat fiha 1,000 mg ta' aċidu nikotiniku u 20 mg laropiprant.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
Maltese: • Evita li tixrob alkoħol jew xarbiet sħan jew li tiekol ikel pikkanti qrib il-ħin meta għandek tieħu Pelzont.
English: Additional explanations that do not invoke plasma FFA reduction as the central driver of lipid profile modification include nicotinic acid-mediated inhibition of de novo lipogenesis or esterification of fatty acids into TG in the liver.
Maltese: L-aċidu nikotiniku jgħaddi minn metaboliżmu first-pass estensiv minn żewġ passaġġi li huma dipendenti fuq id-doża u fuq ir-rata tad-doża.
English: The full EPAR for Actraphane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Actraphane, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Maltese: Is-sustanza attiva f'Actraphane, l-insulina umana, hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti': dan isir minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-insulina.
English: Actraphane is a suspension for injection that contains the active substance human insulin.
Maltese: Actraphane huwa sospensjoni għall-injezzjoni li fiha s-sustanza attiva insulina umana.
English: This is a summary of the European public assessment report (EPAR) for Actraphane.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Actraphane.
English: The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Maltese: L-istudju qabbel Actraphane 30 ma' taħlita simili, iżda magħmula permezz tal-użu tal-insulina analoga (insulina aspart).
English: Why has Actraphane been approved?
Maltese: Għaliex ġie approvat Actraphane?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actraphane on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Actraphane valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2002.
English: Actraphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Maltese: Actraphane huwa insulina ta' sostituzzjoni simili ħafna għall-insulina prodotta mill-frixa.
English: Actraphane is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Maltese: Actraphane jingħata bħala injezzjoni taħt il-ġilda, normalment fil-koxxa, fl-addome (fil-parti ta' quddiem tal-qadd), fil-parti tal-glutei (il-warrani) jew fil-parti deltojde (l-ispalla).
English: Actraphane is given 30 minutes before a meal.
Maltese: Actraphane jingħata 30 minuta qabel l-ikel.
English: Actraphane contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an isophane form, which is absorbed much more slowly during the day.
Maltese: Actraphane fih l-insulina f'żewġ forom: fil-forma li tinħall, li taġixxi malajr (fi żmien 30 minuta mill-injezzjoni) u fil-forma isophane, li tiġi assorbita b'mod inqas mgħaġġel matul il-jum.
English: How has Actraphane been studied?
Maltese: Kif ġie studjat Actraphane?
English: Other information about Actraphane
Maltese: Kif jintuża Actraphane?
English: It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen).
Maltese: Jiġi fi vjali, stoċċijiet (Penfill) jew pinen mimlija minn qabel (InnoLet jew FlexPen).
English: Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:
Maltese: L-EPAR sħiħ għal Actraphane jinstab fis-sit elettroniku tal-Aġenzija:
English: What is Actraphane?
Maltese: X'inhu Actraphane?
English: What is the risk associated with Actraphane?
Maltese: X'inhu r-riskju assoċjat ma' Actraphane?
English: Actraphane led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Maltese: Actraphane wassal għal tnaqqis fil-livell ta' HbA1c, u b'hekk indika li l-livelli tal-glukożju fid-demm ġew ikkontrolati għal livell simili bħal b'insulina umana oħra.
English: Actraphane has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Maltese: Actraphane ġie studjat f'total ta' 294 pazjent bid-dijabete tat-tip1, fejn il-frixa ma tistax tipproduċi linsulina, u tad-dijabete tat-tip 2, fejn il-ġisem mhuwiex kapaċi juża l-insulina b'mod effettiv.
English: The most common side effect with Actraphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni b'Actraphane (li deher f'iktar minn pazjent 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: A risk management plan has been developed to ensure that Actraphane is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Actraphane jintuża bl-aktar mod sigur possibbli.
English: The CHMP decided that Actraphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Actraphane huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Actraphane is used to treat diabetes.
Maltese: Actraphane jintuża fil-kura tad-dijabete.
English: ATCvet code: QI09AE03.
Maltese: QI09AE03.
English: CFU/dose
Maltese: CFU/doża
English: 80689 München GERMANY
Maltese: 80689 München
English: 50 doses 4 x 50 doses 200 doses
Maltese: 50 doża 4 x 50 doża 200 doża
English: to 9.0 x10
Maltese: sa 9.0 x 10
English: 50 doses 200 doses
Maltese: 50 doża 200 doża
English: Poligono La Relva, Torneiros s/n 36410 Porriño (Pontevedra) SPAIN
Maltese: Poligono La Relva, Torneiros s/n 36410
English: Monosodium glutamate Purified water
Maltese: Monosodium glutamate Ilma ppurifikat
English: As an example, for a 4-hour consumption of 22 l and a dosing pump rate of 1%, the volume of the stock solution should be 22 l x 0.01 = 220 ml.
Maltese: Bħala eżempju, għal konsum ta' 4 sigħat ta' 22 l u rata tal-pompa tad-dożaġġ ta' 1%, il-volum tas-soluzzjoni ewlenija għandu jkun 22 l x 0.01 = 220 ml.
English: CFU 2/dose not attenuated CFU = colony forming units
Maltese: CFU 2/doża mhux attenwat CFU = unitajiet li jiffurmaw kolonji
English: 1............................1.3x 10
Maltese: ħajja mhux patoġenika............................1.3 x 10
English: Prevtec Microbia GmbH 80689 München GERMANY
Maltese: Prevtec Microbia GmbH 80689 München IL-ĠERMANJA
English: The final concentration of the skimmed milk powder should be 5 g/litre.
Maltese: Ilkonċentrazzjoni finali tat-trab tal-ħalib xkumat għandha tkun 5 g/litru.
English: Zero days.
Maltese: Zero jiem
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' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn annimal 1 minn 10 ikkurati juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: Vials (50 or 200 doses)
Maltese: Kunjetti (50 jew 200 doża)
English: Manufacturer responsible for batch release: CZ Veterinaria S.A.
Maltese: Manifattur responsabbli għall-ħrug tal-lott: CZ Veterinaria S.A.
English: Live E.coli, O8:K87 (F4ac).
Maltese: E.coli, O8:K87 (F4ac) ħajja.
English: Vaccination by drench application:
Maltese: Tilqima b'applikazzjoni drench:
English: No adverse reactions other than those stated under section 4.6 have been observed after administration of 10 times the recommended dose.
Maltese: Ebda reazzjoni avversa barra dawk iddikjarati f'sezzjoni 4.6 ma ġiet osservata wara amministrazzjoni ta' 10 darbiet id-doża rrakkomandata.
English: Date of first authorisation:16/03/2015 Date of latest renewal: dd/mm/yyyy
Maltese: Data tal-ewwel awtorizzazzjoni:16/03/2015
English: Duration of immunity: 21 days after vaccination.
Maltese: Tul ta' immunità: 21 jum wara t-tilqima.
English: Type I glass vial of 6 ml containing 50 doses and of 11 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminum cap.
Maltese: Kunjett tal-ħġieġ ta' tip I ta' 6 ml li fih 50 doża u ta' 11 ml li fih 200 doża b'tapp tal-lastiku chlorobutyl issiġillat b'kappa tal-aluminju.
English: For active immunisation of pigs against enterotoxigenic F4-positive Escherichia coli in order to: - reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs - reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.
Maltese: Għal immunizzazzjoni attiva għall-ħnieżer kontra Escherichia coli enterotossiġenika pożittiva għal F4 sabiex: - tnaqqas l-inċidenza ta' dijarea tal-Escherichia coli moderata sa severa wara t-treddigħ (PWD) fil-ħnieżer - tnaqqas il-kolonizzazzjoni tal-iljum u tixrid mill-ippurgar ta' Escherichia coli enterotossiġenika pożittiva għal F4 minn ħnieżer infettati.
English: Store and transport refrigerated (2 C - 8 C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 C - 8 C).
English: Onset of immunity: 7 days after vaccination.
Maltese: Bidu tal-immunità: 7 ijiem wara t-tilqima.
English: (F4ac).............1.3 x10
Maltese: (F4ac) ħaj u mhux patoġeniku..............1.3 x 10
English: Pack sizes:
Maltese: Daqs tal-pakketti:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma sustanzi ammissibbli li għalihom tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li m'hemm bżonn ta' ebda MRL jew li huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/)
English: The final suspension containing the vaccine should be consumed within 4 hours after preparation.
Maltese: Is-sospensjoni finali li fiha t-tilqima għandha tiġi kkunsmata fi żmien 4 sigħat wara l-preparazzjoni.
English: Cardboard box of one vial of 200 doses.
Maltese: Kaxxa tal-kartun ta' kunjett wieħed ta' 200 doża.
English: Reconstitute the lyophilisate by adding 5 ml (50-dose presentation) or 10 ml (200-dose presentation) of tap water to the vial.
Maltese: Irrikostitwixxi l-lijofiliżat billi żżid 5 ml (preżentazzjoni ta' 50 doża) jew 10 ml (preżentazzjoni ta' 200 doża) tal-ilma tal-vit fil-kunjett.
English: Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 100 ml.
Maltese: Ħallat sew u ttrasferixxi s-sospensjoni f'kontenitur gradwat, erġa' ħallat mal-ilma tal-vit biex timla sa volum total ta' 100 ml.
English: CFU - colony forming units For the full list of excipients, see section 6.1.
Maltese: CFU 2/doża mhux attenwat CFU - unitajiet li jiffurmaw kolonji Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: The drinking water systems have to be cleaned and intensively rinsed with untreated water to avoid any residues of antimicrobials, detergents or disinfectants.
Maltese: Is-sistemi tal-ilma tax-xorb iridu jitnaddfu u jinħaslu b'mod intensiv b'ilma mhux trattat biex jiġu evitati residwi ta' antimikrobiċi, deterġenti jew diżinfettanti.
English: White or whitish lyophilisate for oral suspension.
Maltese: Lijofiliżat abjad jew bajdani għal sospensjoni orali.
English: The suspension should be administered within 4 hours after preparation.
Maltese: Is-sospensjoni għandha tingħata fi żmien 4 sigħat wara l-preparazzjoni.
English: The vaccine induces an intestinal immunity and a serological response against F4-positive Escherichia coli in pigs.
Maltese: It-tilqima toħloq immunità intestinali u rispons seroloġiku kontra Escherichia coli pożittiv għal F4 filħnieżer.
English: Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 400 ml.
Maltese: Ħallat sew u ttrasferixxi s-sospensjoni f'kontenitur gradwat, erġa' ħallat mal-ilma talvit biex timla sa volum total ta' 400 ml.
English: - reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs.
Maltese: - tnaqqas l-inċidenza ta' dijarea tal-Escherichia coli moderata sa severa wara t-treddigħ (PWD) fil-ħnieżer.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Cardboard box
Maltese: Kaxxa tal-kartun
English: Coliprotec F4 lyophilisate for oral suspension for pigs.
Maltese: Coliprotec F4 lijofiliżat għal sospenzjoni orali għall-ħnieżer.
English: White or whitish lyophilisate.
Maltese: Għall-kura tal-annimali biss.
English: Coliprotec F4 lyophilisate for oral suspension for pigs
Maltese: Coliprotec F4 lijofiliżat għal sospensjoni orali għall-ħnieżer
English: For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive Escherichia coli in order to:
Maltese: Għal immunizzazzjoni attiva għall-ħnieżer mill-età ta' 18-il ġurnata kontra Escherichia coli enterotossiġenika pożittiva għal F4 sabiex:
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva u l-manifattur responsabbli mill-ħruġ tallott:
English: Each dose of vaccine contains: Live non-pathogenic Escherichia coli O8:K87 (F4ac)
Maltese: Kull doża ta' tilqima fiha: Escherichia coli O8:K87 (F4ac)
English: Apply the usual aseptic precautions to all administration procedures.
Maltese: Applika l-prekawzjonijiet asettiċi normali għal kull proċedura ta' amministrazzjoni.
English: To stimulate active immunity against enterotoxigenic F4-positive Escherichia coli in pigs.
Maltese: Biex jistimula l-immunità attiva kontra Escherichia coli pożittiv għal F4 enterotossiġeniku fil-ħnieżer.
English: Do not vaccinate animals undergoing antibacterial treatment effective against Escherichia coli.
Maltese: Tlaqqamx annimali li għaddejjin minn kura antibatterika effettiva kontra Escherichia coli.
English: Shake well.
Maltese: Ħallat sew.
English: Live non-pathogenic Escherichia coli O8:K87
Maltese: Kull doża tat-tilqima fiha: Escherichia coli O8:K87
English: Cardboard box of one vial of 50 doses.
Maltese: Kaxxa tal-kartun ta' kunjett wieħed ta' 50 doża.
English: The active substance being a principle of biological origin intended to produce a state of immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: • For administration through water lines using a dosing pump (proportioner), dilute the reconstituted vaccine in the needed volume of the dosing pump stock solution.
Maltese: • Għal amministrazzjoni minn linji tal-ilma bl-użu ta' pompa tad-dożaġġ (proportioner), iddilwixxi t-tilqima rikostitwita fil-volum meħtieġ għas-soluzzjoni ewlenija tal-pompa tad-dożi.
English: • 50-dose presentation: Reconstitute the lyophilisate by adding 5 ml of tap water to the vial.
Maltese: • Preżentazzjoni ta' 50 doża: Irrikostitwixxi l-lijofiliżat billi żżid 5 ml ta' ilma tal-vit mal-kunjett.
English: Pharmacotherapeutic group: immunologicals for Suidae live bacterial vaccines for pigs.
Maltese: Grupp farmako-terapewtiku: immunoloġiċi għal tilqim Suidae ta' batterji ħajjin għall-ħnieżer.
English: Live non-pathogenic Escherichia coli O8:K87 (F4ac): 1.3 x10
Maltese: Escherichia coli O8:K87 (F4ac) ħajja mhux patoġenika:
English: Cardboard box of four vials of 50 doses.
Maltese: Kaxxa tal-kartun ta'erba' kunjetti ta' 50 doża.