FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP concluded that according to “current” GCP requirements this pivotal study design has many deficiencies.
Maltese: CVMP ikkonkluda li skond il-ħtiġiet ta' GCP “attwali” dan id-disinn ta' studju ewlieni għandu ħafna nuqqasijiet.
English: Given that the statistical analysis is appropriate, this study design can conclude that the actual final formulation has shown field efficacy when compared to a negative control group and has produced as least as good results as a comparator product TM550 (oxytetracycline).
Maltese: Minħabba li l-analiżi statistika hija waħda xierqa, dan id-disinn ta' studju jista' jikkonkludi li lformulazzjoni finali proprja uriet effikaċja fil-qasam meta mqabbla mal-grupp ta' kontroll negattiv u għallinqas ipproduċiet riżultati tajbin daqs prodott komparattiv TM550 (oxytetracycline).
English: Contraindications
Maltese: KARATTERISTIĊI
English: In two-by-two analysis, both Doxyprex groups were significantly quicker to cure than the negative control and the positive control groups.
Maltese: F'analiżi tnejn-bi-tnejn, iż-żewġ gruppi ta' Doxyprex ġew ikkurati ferm aktar malajr mill-kontroll negattiv u l-gruppi ta' kontroll pożittiv.
English: The clinical end points were ”Time to clinical cure” and ”overall clinical cure”.
Maltese: Il-punti ta' tmiem kliniċi kienu “Żmien għal kura klinka” u “kura klinika globali”.
English: The choice of positive control products and the dosing regiment applied were discussed:
Maltese: L-għażla ta' prodotti ta' kontroll pożittivi u r-reġimen tad-doża applikata ġew diskussi:
English: Thermosealed bags of a complex film made of polyester external layer, aluminium intermediate layer and polyethylene internal layer that is in contact with the product.
Maltese: Boroż thermosealed ta' rita kumplessa magħmula minn saff estern tal-polyester, saff intermedju ta' laluminju u saff intern tal-polyethylene li jmiss mal-prodott.
English: LABELLING AND PACKAGE INSERT
Maltese: FIL-PAKKETT
English: It was pointed out that even though there are small differences in dosage the mean and maximum steady state plasma concentration are similar.
Maltese: Ġie nnotat li minkejja li hemm differenzi żgħar fid-doża l-istat kostanti intermedju u massimu ta' konċentrazzjoni ta' plażma huma simili.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of intolerance to the speciality have been detected in the studies conducted in which a medicated feed with 600 ppm (2.4 times the recommended dose) was administered to the 20-30 kg animals during twice the recommended period.
Maltese: L-ebda sintomi ta' intolleranza għall-ispeċjalità ma kienu osservati fl-istudji li saru li fihom l-għalf bilmediċina b'600 ppm (2.4 darbiet tad-doża rakkomandata) ingħata lill-annimali ta' 20-30 kg matul iddoppju tal-perijodu rakkomandat.
English: MANUFACTURER'S BATCH NUMBER Batch: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott:
English: Pharmacodynamic properties
Maltese: Kwalitajiet Farmakodinamiċi
English: It reaches well irrigated and peripheral tissues.
Maltese: Jilħaq tessut li jkun irrigat tajjeb u dak periferali.
English: “For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Maltese: “Għat-trattament u l-prevenzjoni tal-marda respiratorja fil-majjali ikkaġunata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l-marda ġiet djanjostikata fil-merħla.
English: Pharmacotherapeutic group: Antibacterials for systemic use.
Maltese: KWALITAJIET FARMAKOLOĠIĊI Grupp Farmako-terapewtiku:
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP.
Maltese: Id-Detentur ta' lAwtorizzazzjoni ta' Kummerċjalizzazzjoni (MAH) ġie mitlub jissostanzja l-indikazzjoni u lpożoloġija kif diskussa matul l-MRP riċenti.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {<DD/MM/YYYY>}
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA {<JJ/XX/SSSS>}
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Maltese: Għalhekk, CVMP jikkunsidra li r-rapporti msemmijin hawn fuq jagħtu provi favorevoli għas-sigurtà u l-effikaċja ta' doxycycline in ġenerali, iżda wkoll għall-formulazzjoni finali speċifika kif ikkummerċjalizzata fi Spanja.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Doxyprex hu fornut fi granuli sofor li fihom 100 mg ta' bażi ta' doxycycline bħala hyclate f'kull gramma ta' prodott.
English: The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P.multocida and B.bronchiseptica.
Maltese: L-applikant mexxa prova tal-qasam b'żewġ ċentri b'ordni każwali u kkontrollata ewlenija bl-użu tal-formulazzjoni finali tagħhom biex juri l-effikaċja għal mard respiratorju kkawżat minn P.multocida u B.bronchiseptica.
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Maltese: L-Anness I tad-Direttiva 2001/82/KE kif emendat bid-direttiva 2004/28/KE jinnota li l-esperjenza ta' wara l-kummerċjalizzazzjoni ma' prodotti oħrajn li tinkludi l-istess kostitwenti hija ta' importanza partikolari u l-applikanti għandhom jagħmlu enfażi speċjali fuq din il-kwistjoni.
English: The positive control products were chosen on the basis that they were also medicated premixes, indicated for use in pigs, which contained a single active substance, which had a spectrum of activity inclusive of those organisms causing the proposed indications.
Maltese: Il-prodotti ta' kontroll pożittiv ġew magħżulin fuq il-bażi li huma kienu wkoll premixes medikati, indikati għall-użu fil-majjali, li kien fihom sustanza attiva unika, li kellha spettru ta' attività li tinkludi dawk l-organiżmi li jikkawżaw l-indikazzjonijiet proposti.
English: In the introduction to the responses the applicant has given a justification for submission of this application on a “well-established use” basis.
Maltese: In-nuqqas ta' provi ta' kura bijoloġika għandhom jiġu ġġustifikati u dan jista' taffettwa l-formulazzjoni ta' l-indikazzjoni.
English: In feed use
Maltese: U KWANTITATTIVA
English: For pigs with a daily consumption of 40 g of feed/kg b.w./day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/Ton..
Maltese: Għal qżieqeż li jikkonsmaw kuljum 40 g ta' għalf/kg p.ġ/kuljum, din id-doża tikkorrispondi għal 250 mg ta' doxycycline għal kull kilogramm ta' għalf, li tagħti rata ta' inkorporazzjoni ta' 2.5 kg/Tunnellata.
English: The recommended dose is 10 mg of doxycycline/kg of body weight/day (equivalent to 1 g of Doxyprex/10 kg of b.w.)
Maltese: Id-doża rakkomandata hi ta' 10 mg ta' doxycycline/kg ta' piż tal-ġisem/kuljum (ekwivalenti għal 1 g ta' Doxyprex/10 kg ta' p.ġ.) għal 7 ijiem konsekuttivi.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ: 3 snin.
English: Animal species
Maltese: Ceva Santé Animale
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu intramuskolari.
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: Iron (III)
Maltese: Ħadid (III)
English: Pharmacotherapeutic group: Toltrazuril, combinations ATCvet code: QP51AJ51
Maltese: Toltrazuril, kombinazzjonijiet Kodiċi ATC veterinarja: QP51AJ51
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/04/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23/04/2019
English: (as gleptoferron
Maltese: (bħala gleptoferron
English: Translucent multi-layered plastic (polypropylene/ethylene vinyl alcohol/polypropylene) vials with bromobutyl rubber stoppers coated with a fluor film and aluminium and plastic flip capsules, containing 100 ml, 250 ml or 500 ml.
Maltese: Kunjetti tal-plastik trasluċidi ta' diversi saffi (polypropylene/ethylene vinyl alcohol/polypropylene) b'tappijiet tal-lastku bromobutyl miksija b'kisi ta' fluwor u b'kapsuli li tifflippja tal-aluminju u lplastik li fihom 100 ml, 250 ml jew 500 ml.
English: Toltrazuril is primarily metabolised into toltrazuril sulfone.
Maltese: Toltrazuril jiġi prinċipalment metabolizzat f'toltrazuril sulfone.
English: Meat and offal: 70 days.
Maltese: Laħam u ġewwieni: 70 jum.
English: Iron (as gleptoferron)
Maltese: Ħadid (bħala gleptoferron)
English: For the 250 ml and 500 ml vials, the rubber stopper may be punctured up to 20 times.
Maltese: Għall-kunjetti ta' 250 ml u 500 ml, it-tapp tal-lastku jista' jittaqqab sa 20 darba.
English: Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Maltese: Toltrazuril huwa derivat ta' triazinon u sustanza antiprotozoali.
English: The product is recommended in piglets weighing between 0.9 and 3 kg.
Maltese: Il-prodott hu rakkomandat għal ħannus li jiżen bejn 0.9 u 3 kg.
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 il-konvenzjoni li ġejja: - komuni ħafna (aktar minn 1 f'kull 10 annimali trattati li juru reazzjoni(jiet) avversi) - komuni (aktar minn 1 imma inqas minn 10 annimali f'100 annimal itrattati ) - mhux komuni (aktar minn 1 imma inqas minn 10 annimali f'1,000 annimal itrattati) - rari (aktar minn 1 imma inqas minn 10 annimali f'10,000 annimal trattati ) - rari ħafna (inqas minn animal 1 f'10,000 animal trattati, li jinkludu rapporti iżolati)
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji ta' kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża ma' prodotti veterinarji oħra.
English: STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 30 mg toltrazuril and 133 mg iron (III) (as gleptoferron)
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI U SUSTANZA OĦRA 1 ml fih 30 mg toltrazuril u 133 mg ħadid (III) (bħala gleptoferron)
English: Toltrazuril and toltrazuril sulfone were eliminated slowly with a half-life of 3 days each.
Maltese: Toltrazuril u toltrazuril sulfone kienu eliminati bil-mod b'half-life ta' 3 ijiem kull wieħed.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)
Maltese: VETERINARJU Forceris 30 mg/ml + 133 mg/ml sospenjoni għall-injezzjoni għal ħannus toltrazuril / iron (III) (bħala gleptoferron)
English: 6.4 mg For the full list of excipients, see section 6.1.
Maltese: 6.4 mg Għal-lista sħiħa tal-ingredienti (mhux attivi), ara sezzjoni 6.1.
English: After intramuscular injection of 1.5 ml/piglet of Forceris, iron is absorbed rapidly from the injection site into the capillaries and the lymphatic system and a maximal concentration of 645 µg/ml was reached after approximately 0.5 day, the AUC was about 699 day.µg/ml.
Maltese: Wara injezzjoni intramuskolari ta' 1.5 ml/ħannus ta' Forceris, il-ħadid jiġi assorbit malajr mis-sit t'injezzjoni ġol-kapillari u s-sistema limfatika u konċentrazzjoni massima ta' 645 µg/ml tintlaħaq wara madwar 0.5 jum, l-AUC kienet ta' madwar 699 jum.µg/ml.
English: Dark brown suspension.
Maltese: Suspensjoni kannella skura.
English: It has coccidiocidal activity against all intracellular development stages of the genera Cystoisospora, that is, merogony (asexual multiplication) and gamogony (sexual phase).
Maltese: Għandu attività kokkidjocidali kontra kull stadju ta' żvilupp intraċellulari tal-ġeneru Cystoisospora, jiġifieri, merogonja (multiplikazzjoni asesswali) u gamogonja (fażi sesswali).
English: For the 100 ml vials, the rubber stopper may be punctured up to 30 times.
Maltese: Għall-kunjetti ta' 100 ml, it-tapp tal-lastku jista' jittaqqab sa 30 darba.
English: Pack sizes:
Maltese: Tqala u treddigħ:
English: During overdosage studies, a transient reduced erythrocyte count, haematocrit and hemoglobin concentration without clinical signs was observed after day 14 following single administration in the target animal safety studies at three times the highest recommended dose (mean 261 mg/piglet toltrazuril and 1156 mg/piglet iron).
Maltese: Waqt studji dwar dożi eċċessivi, tnaqqis temporanju fl-għadd ta' eritroċiti, ematokrit u filkonċentrazzjoni ta' emoglobina mingħajr sinjali kliniċi kienu osservati f'jum 14 wara għotja waħda flistudji ta' sikurezza tal-annimal fil-mira f'doża li kienet tliet darbiet l-ogħla doża rakkomandata (medja 261 mg/toltrazuril fil-ħannus u 1156 mg/ħadid fil-ħannus).
English: After intramuscular administration of 1.5 ml/piglet of Forceris, maximal concentrations of 7 mg/l of toltrazuril were reached about 6 days after administration (Tmax ranging from 4 to 7 days), and the AUC was about 57 day.mg/l.
Maltese: Wara l-għoti intramuskolari ta' 1.5 ml/ħannus ta' Forceris, il-konċentrazzjonijiet massimi ta' 7 mg/l ta' toltrazuril ġew milħuqa madwar 6 ijiem wara l-għoti (Tmax li jvarjaw minn 4 sa 7 ijiem), u l-AUC kienet ta' madwar 57 day.mg/l.
English: The recommended dose is 45 mg of toltrazuril and 200 mg of iron per piglet, that is, 1.5 ml of Forceris suspension per piglet, to be administered once, in a single intramuscular injection behind the ear, between 24 and 96 hours after birth.
Maltese: Id-doża rakkomandata hi ta' 45 mg ta' toltrazuril u 200 mg ta' ħadid għal kull ħannus, jiġifieri, 1.5 ml ta' suspensjoni ta' Forceris għal kull ħannus, li għandha tingħata darba, b'injezzjoni intramuskolari waħda wara l-widna, bejn 24 u 96 siegħa wara t-twelid.
English: Box with 1 vial of 250 ml.
Maltese: Kaxxa b'kunjett 1 ta' 250 ml.
English: STATEMENT OF THE MRLs The active substances in Forceris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: Pharmacologically active substances
Maltese: Is-sustanzi attivi f'Forceris huma ammissibbli kif deskritt fit-tabella 1 fl-anness tar-Regolament talKummissjoni (UE) Nru 37/2010:
English: The “No MRL required” classification for iron dextran and iron glucoheptonate is considered to apply to gleptoferron as gleptoferron is expected to release iron dextran and iron glucoheptonate.
Maltese: Il-klassifikazzjoni ta' “L-ebda MRL mhu meħtieġ ” għal iron dextran u iron glucoheptonate hu kkonsidrat li japplika għal gleptoferron peress li gleptoferron hu mistenni li jerħi iron dextran u iron glucoheptonate.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
Maltese: VETERINARJU Forceris 30 mg/ml + 133 mg/ml sospenjoni għall-injezzjoni għal ħannus
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001-003
Maltese: FIS-SUQ EU/2/19/235/001-003
English: Antiparasitic agents/ Agents acting against protozoa
Maltese: Sustanzi antiparasitiċi/ Sustanzi li jaġixxu kontra lprotożoa
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: Pigs (piglets 24 to 96 hours after birth)
Maltese: Qżieqeż (ħannus 24 sa 96 siegħa wara t-twelid)
English: Iron is an essential micronutrient.
Maltese: Il-ħadid huwa mikronutrijent essenzjali.
English: It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg.
Maltese: Mhux rakkomandat li tuża l-prodott mediċinali veterinarju f'ħannus li jiżen inqas minn 0.9 kg.
English: Accidental self-injection may cause local reactions such as irritation, granulomas, or severe anaphylactic reactions in sensitive people.
Maltese: F'każ li tinjetta lilek innifsek b'mod aċċidentali jistgħu jfeġġu reazzjonijiet lokali bħal irritazzjoni, granuloma, jew reazzjonijiet anafilattiċi severi f'persuni sensittivi.
English: Box with 1 vial of 500 ml.
Maltese: Kaxxa b'kunjett 1 ta' 500 ml.
English: At 3 times the recommended dose (135 mg/piglet toltrazuril and 600 mg/piglet iron) only a slight transient reduced erythrocyte count was observed after 21 days.
Maltese: Wara 21 jum, b'doża 3 darbiet iddoża rakkomandata (135 mg/toltrazuril fil-ħannus u 600 mg/ħadid fil-ħannus) ġie osservat għadd temporanju ftit aktar baxx ta' eritroċiti.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001 (100 ml)
Maltese: FIS-SUQ EU/2/19/235/001 (100 ml)
English: Following intramuscular injection, gleptoferron is absorbed and metabolised to release the iron for use and/or storage in accordance with the nutritional status of the animal.
Maltese: Wara injezzjoni intramuskolari, gleptoferron jiġi assorbit u metabolizzat biex jerħi l-ħadid għall-użu u/jew ħażna skont l-istat nutrizzjonali tal-annimal.
English: For porcine species the fat MRL relates to ‘skin and fat in natural proportions'.
Maltese: Għal speċi ta' qżieqeż l-MRL tal-grass jirrelata għal ‘ġilda u grass fi proporzjonijiet naturali'.
English: After intramuscular administration of 1.5 ml/piglet of Forceris the maximal concentration of 10 mg/l for toltrazuril sulfone was reached about 13 days after administration (Tmax ranging from 10 to 19 days), and the AUC was about 183 day.mg/l.
Maltese: Wara l-għoti intramuskolari ta' 1.5 ml/ħannus ta' Forceris il-konċentrazzjoni massima ta' 10 mg/l għal toltrazuril sulfone intlaħqet madwar 13-il jum wara l-għoti (Tmax li jvarja minn 10 sa 19-il jum), u l-AUC kien ta' madwar 183 jum.mg/l.
English: Doses higher than 150 mg/kg/day and 667 mg/kg/day for toltrazuril and iron respectively, i.e. 3 times the highest recommended dose, have not been evaluated in the target animal safety studies.
Maltese: Dożi ogħla minn 150 mg/kg/jum and 667 mg/kg/jum għal toltrazuril u ħadid rispettivament, i.e. 3 darbiet l-ogħla doża rakkomandata ġew valutati fl-istudji ta' sikurezza fuq l-annimal fil-mira.
English: PACKAGE LEAFLET Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
Maltese: FULJETT TA' TAGĦRIF Forceris 30 mg/ml + 133 mg/ml sospenjoni għall-injezzjoni għal ħannus
English: EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Maltese: DATA TA' SKADENZA Jiskadi {xahar/sena} Ladarba jinfetaħ, uża fi żmien 28 jum.
English: Liver Kidney
Maltese: Grass Fwied Kliewi
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-eċċipjenti elenkati f'sezzjoni 6.1 tas-SKP huma jew sustanzi permessi li għalihom tabella 1 talanness għar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li l-ebda MRL mhu meħtieġ jew huma kkonsidrati li ma jaqgħux taħt l-iskop tar-Regolament (KE) Nru 470/2009 meta jintuża f'dan il-prodott mediċinali veterinarju.
English: For the concomitant prevention of iron deficiency anaemia and prevention of clinical signs of coccidiosis (diarrhoea) as well as reduction in oocyst excretion, in piglets in farms with a confirmed history of coccidiosis caused by Cystoisospora suis.
Maltese: Għall-prevenzjoni konkomitanti ta' anemija minħabba nuqqas ta' ħadid u l-prevenzjoni ta' sinjali kliniċi ta' kokkidjosi (dijarea) kif ukoll tnaqqis ta' eliminazzjoni ta' ooċiti, f'ħannus f'irziezet bi storja konfermata ta' kokkidjosi kaġunata minn Cystoisospora suis.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 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 ta' l-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Box with 1 vial of 100 ml.
Maltese: Kaxxa b'kunjett 1 ta' 100 ml.
English: Disposal: read package leaflet.
Maltese: Ir-rotta ewlenija ta' eliminazzjoni hi permezz tal-ippurgar.
English: Muscle Skin and fat Liver Kidney
Maltese: Ġilda u grass Fwied Kliewi
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: Sustanzi farmakoloġikament attivi
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu ta' tiżmin
English: It plays a major role in the transport of oxygen via haemoglobin and myoglobin, as well as having a key role in enzymes, such as cytochromes, catalases, and peroxidases.
Maltese: Huwa jilgħab rwol ewlieni fit-trasport ta' ossiġenu permezz tal-emaglobina u l-mijoglobina, kif ukoll għandu rwol importanti f'enzimi bħal ċitokromi, catalases u peroxidases.
English: B. PACKAGE LEAFLET
Maltese: Daqsijiet tal-pakkett
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Maltese: Aħsel l-idejn wara li tuża.
English: Injectable iron-carbohydrate complexes, such as gleptoferron, are established haematinic agents in veterinary medicine and are effective in significantly increasing the haemoglobin levels in piglets raised under intensive farming conditions in which an all milk diet for several weeks does not provide an adequate source of iron.
Maltese: L-esponiment għall-prodott mediċinali veterinarju jista' jikkaġuna irritazzjoni għall-għajnejn jew effetti avversi fuq il-ġilda.
English: WITHDRAWAL PERIOD(S) Meat and offal: 70 days.
Maltese: Perjod(u/i) ta' tiżmim Laħam u ġewwieni: 70 jum.
English: CONTRAINDICATIONS Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
Maltese: KONTRAINDIKAZZJONIJIET M'għandekx tuża f'ħannus suspettati li jbati min-nuqqas ta' vitamina E u/jew selenju.
English: As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Maltese: Bħal fil-każ ta' kull antiparasitiċida, l-użu frekwenti u ripetut ta' antif antiprotożoali mill-istess klassi jista' jwassal għall-iżvilupp ta' reżistenza.
English: The responsible veterinarian should take into account the results of clinical examinations and/or analysis of faecal samples and/or histological findings which confirmed the presence of C. suis in a previous infection episode on the farm.
Maltese: Il-veterinarju responsabbli għandu jqis ir-riżultati ta' eżami kliniku u/jew lanaliżi ta' kampjuni ta' ppurgar u/jew riżultati ħistoloġiċi li kkonfermaw il-preżenza ta' C. suis if'episodju ta' infezzjoni preċedenti fir-razzett.
English: MESNA IV days 29-33
Maltese: MESNA IV jiem 29-33
English: Total bilirubin: >1.5-3.0 ULN
Maltese: Bilirubina totali: >1.5-3.0 ULN
English: Poland medac
Maltese: Il-Polonja medac
English: Marszalka J. Pilsudskiego 5
Maltese: Marszałka Józefa Piłsudskiego 5
English: ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Maltese: ULN = il-limitu ta' fuq in-normal tal-instituzzjoni AST = aspartate aminotransferase
English: 9/l) were observed in 3.6 % and < 1 % of patients, respectively.
Maltese: 9/l) f'3.6% u f'< 1% tal-pazjenti, rispettivament.
English: Pabianickie Zaklady Farmaceutyczne Polfa S.A. ul.
Maltese: Pabianickie Zaklady Farmaceutyczne Polfa S.A.