FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first two studies involving 1,118 adults with complicated skin and soft tissue infections (mainly wound infections and major abscesses), Cubicin was effective in 67% of patients in one study and in 85% in the other.
Maltese: Fl-ewwel żewġ studji li fihom ħadu sehem 1,118-il adult b'infezzjonijiet ikkumplikati tal-ġilda u tattessut artab (l-aktar infezzjonijiet ta' feriti u axxessi kbar), Cubicin kien effettiv f'67% tal-pazjenti fi studju wieħed u f'85% fl-ieħor.
English: In the group with endocarditis, treatment was successful in 42% (8 out of 19) of the patients receiving Cubicin compared with 44% (7 out of 16) of the patients receiving standard treatment.
Maltese: Fil-grupp b'endokardite, il-kura rnexxiet fi 42% (8 minn 19) tal-pazjenti li kienu qed jirċievu Cubicin meta mqabbel ma' 44% (7 minn 16) tal-pazjenti li kienu qed jirċievu kura standard.
English: In children the dose of Cubicin for skin or soft tissue infection without bacteraemia depends on the child's age and ranges between 5 and 10 mg/kg once a day.
Maltese: Fit-tfal id-doża ta' Cubicin għal infezzjoni tal-ġilda jew tat-tessut artab mingħajr batteremija tiddependi fuq l-età tat-tfal u tvarja bejn 5 u 10 mg/kg darba kuljum.
English: Treatment was successful in 88% (45 out of 51) of the patients receiving Cubicin compared with 77% (17 out of 22) receiving standard treatment.
Maltese: Il-kura rnexxiet f'88% (45 minn 51) tal-pazjenti li kienu qed jirċievu Cubicin meta mqabbel ma' 77% (17 minn 22) ta' dawk li kienu qed jirċievu kura standard.
English: The first study in children and adolescents involved 396 patients with complicated skin and soft tissue infections without bacteraemia.
Maltese: Fl-ewwel studju fuq tfal u adolexxenti ħadu sehem 396 pazjent b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab mingħajr batteremija.
English: Cubicin is an antibiotic medicine, which is used to treat the following bacterial infections:
Maltese: Cubicin huwa mediċina antibijotika, li tintuża għall-kura tal-infezzjonijiet batteriċi li ġejjin:
English: Higher doses (between 7 and 12 mg/kg once a day) are used if the skin or soft tissue infection is associated with bacteraemia.
Maltese: Dożi ogħla (bejn 7 u 12 mg/kg darba kuljum) jintużaw jekk l-infezzjoni tal-ġilda jew tat-tessut artab tkun assoċjata ma' batteremija.
English: In adults, for skin or soft tissue infections without bacteraemia, Cubicin is given at a dose of 4 mg/kg body weight once a day.
Maltese: Fl-adulti, għal infezzjonijiet tal-ġilda jew tat-tessut artab mingħajr batteremija, Cubicin jingħata f'doża ta' 4 mg/kg tal-piż tal-ġisem darba kuljum.
English: For the full list of side effects and restrictions with Cubicin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Cubicin, ara l-fuljett ta' tagħrif.
English: The third study involved 246 adults with bacteraemia caused by S. aureus, including 35 who also had right-sided infective endocarditis.
Maltese: Aureus, fosthom 35 li kellhom ukoll endokardite infettiva fuq in-naħa tal-lemin.
English: There was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and softtissue infections.
Maltese: Ma kienx hemm biżżejjed evidenza biex issostni l-użu ta' Cubicin filkura ta' batteremija f'pazjenti li la kellhom endokardite infettiva fuq in-naħa tal-lemin u lanqas infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab.
English: The duration of treatment with Cubicin depends on the risk of complications and official recommendations.
Maltese: It-tul tal-kura b'Cubicin jiddependi fuq ir-riskju ta' kumplikazzjonijiet u rakkomandazzjonijiet uffiċjali.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom sedation and analgesia depend on the dose that is used.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom l-fond tas-sensazzjoni u l-analġeżija jiddependu mid-doża li tkun qed tintuża.
English: The full EPAR for Cepedex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Cepedex is an alpha2-adrenoceptor agonist.
Maltese: Cepedex huwa agonista alfa2-adrenoċettur.
English: This is a summary of the European public assessment report (EPAR) for Cepedex.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cepedex.
English: Other information about Cepedex?
Maltese: Informazzjoni oħra dwar Cepedex?
English: The company provided information on the quality and manufacture of Cepedex.
Maltese: Il-kumpanija pprovdiet informazzjoni dwar il-kwalità u l-manifattura ta' Cepedex.
English: This means that Cepedex is similar to a ‘reference medicine' already authorised in the EU called Dexdomitor.
Maltese: Dan ifisser li Cepedex huwa simili għal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Dexdomitor.
English: No additional studies were needed as Cepedex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as the reference medicine, Dexdomitor.
Maltese: Ma kien meħtieġ l-ebda studju addizzjonali peress li Cepedex huwa mediċina ġenerika mogħtija permezz ta' injezzjoni, huwa simili fil-kompożizzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Dexdomitor.
English: Why is Cepedex approved?
Maltese: Għaliex ġie approvat Cepedex?
English: The Committee recommended that Cepedex be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Cepedex ikun approvat għall-użu fl-UE.
English: Because Cepedex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Cepedex huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: It works by attaching to receptors known as alpha2-adrenergic receptors and preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Maltese: Dan jaħdem billi jeħel mar-riċetturi magħrufa bħala riċetturi alfa2-adrenerġiċi u jipprevjeni r-rilaxx tan-newrotrażmettitur noradrenalina miċ-ċelloli tan-nervituri fil-ġisem.
English: What are the benefits and risks of Cepedex?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Cepedex?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cepedex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when giving Cepedex.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Cepedex, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom meta jamministraw Cepedex.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Cepedex has been shown to have comparable quality to Dexdomitor.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, Cepedex wera li għandu kwalità komparabbli għal Dexdomitor.
English: Because Cepedex is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Maltese: Billi Cepedex huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-prekawzjonijiet huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Maltese: Peress li n-noradrenalina tgħin biex iżżomm lill-annimal żvelt u mqajjem, it-tnaqqis tar-rilaxx tagħha jnaqqas il-livell ta' kuxjenza, inkluża s-sensazzjoni tal-uġigħ.
English: Cepedex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).
Maltese: Cepedex jista' jintuża wkoll fil-klieb sabiex jipprovdi serħan mill-uġigħ u sedazzjoni fil-fond meta jitwettqu proċeduri mediċi u kirurġija minuri fejn jintuża f'kombinament ma' butorphanol (sedattiv u analġeżiku). Cepedex fih is-sustanza attiva dexmedetomidine u huwa “mediċina ġenerika”.
English: How has Cepedex been studied?
Maltese: Kif ġie studjat Cepedex?
English: 1 pre-filled syringe of 150 mg + 2 needles, 1 prefilled syringe 100 mg + 2 needles
Maltese: Siringa 1 mimlija għal-lest ta' 150 mg + 2 labar, Siringa 1 mimlija għal-lest 100 mg + 2 labar
English: Initiation pack:
Maltese: Pakkett tal-bidu:
English: Prolonged release suspension for injection
Maltese: Suspensjoni li tintreħa bilmod għall-injezzjoni
English: Αντρέα Μιαούλη 50 CY-2415 Έγκωμη, Λευκωσία
Maltese: CY-2415 Έγκωμη, Λευκωσία
English: 4941 SJ Raamsdonksveer Netherlands
Maltese: 4941 SJ Raamsdonksveer L-Olanda
English: Република България Възраждане-Касис ООД бул.
Maltese: Република България Възраждане-Касис ООД
English: United Kingdom Bayer plc
Maltese: Bayer plc
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/239/001
Maltese: EU/2/19/239/001
English: București-Ploiești nr. 1A, sector 1 București 013681-RO
Maltese: București 013681-RO
English: România S.C. Bayer S.R.L.
Maltese: S.C. Bayer S.R.L.
English: PACKAGE SIZE 100 ml
Maltese: 100 mL
English: Toltrazuril-sulfone shows plasma peak concentrations of 6.23 to 8.08 mg/l at 11 to 15 days after injection of the parent drug.
Maltese: Toltrazuril-sulfone juri konċentrazzjonijiet massimi fil-plażma ta' 6.23 sa 8.08 mg/L 11 sa 15-il jum wara l-injezzjoni tal mediċina oriġinali.
English: Toltrazuril reaches peak plasma concentrations of 4.17 to 6.43 mg/l within 5 days.
Maltese: Toltrazuril jilħaq konċentrazzjonijiet massimi fil-plażma ta' 4.17 sa 6.43 mg/L fi żmien 5 ijiem.
English: Total plasma exposure reaches 3868 to 4097 mg*h/l.
Maltese: L-esponiment totali tal-plażma jilħaq 3,868 sa 4,097 mg*siegħa/L.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: From 72 h onwards, this is followed by a very slowly decreasing plasma concentration with a calculated mean half-life of 960 h, indicating equilibrium conditions.
Maltese: dan huwa segwit minn tnaqqis bil-mod ħafna tal-konċentrazzjoni fil-plażma b'half-life medja kkalkulata ta' 960 siegħa, li tindika kondizzjonijiet ta' ekwilibriju.
English: België/Belgique/Belgien Bayer SA-NV
Maltese: België/Belgique/Belgien
English: Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Maltese: Toltrazuril huwa derivattiv ta' triazinon u sustanzi kontra l-protożoa.
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 “MRL mhux meħtieġ” għal iron dextran u iron glucoheptonate hija meqjusa li tapplika għall-gleptoferron peress li gleptoferron huwa mistenni li jerħi iron dextran u iron glucoheptonate.
English: Luxembourg/Luxemburg Bayer SA-NV
Maltese: Bayer SA-NV
English: Total plasma exposure reaches between 1046 and 1245 mg*h/l.
Maltese: L-esponiment totali tal-plażma jilħaq bejn 1,046 u 1,245 mg*siegħa/L.
English: The active substances in Baycox Iron are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanzi attivi f'Baycox Iron huma sustanzi ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
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: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/05/2019
Maltese: Data tal-ewwel awtorizzazzjoni: 20/05/2019
English: Antiparasitic agents/ Agents acting against protozoa
Maltese: Sustanzi kontra l-parassiti / Sustanzi li jaġixxu kontra l-protożoa
English: Slovenija Bayer d.o.o.
Maltese: BAYER d.o.o.
English: Toltrazuril is eliminated from plasma with a halflife of about 3 to 4 days showing substantial metabolism to toltrazuril-sulfoxide and toltrazurilsulfone, the main active metabolite.
Maltese: Toltrazuril jiġi eliminat mill-plażma b'half-life ta' madwar 3 sa 4 ijiem, u juri metaboliżmu sostanzjali għal toltrazuril-sulfoxide u toltrazuril-sulfone, il-metabolit attiv ewlieni.
English: 5 mg For the full list of excipients, see section 6.1.
Maltese: 5 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 36 mg toltrazuril and 182 mg iron (III) (as gleptoferron)
Maltese: 1 mL fih 36 mg toltrazuril u 182 mg ħadid (III) (bħala gleptoferron)
English: The veterinary medicinal product should be administered to piglets between 48 to 72 hours after birth with a single intramuscular injection of 20 mg toltrazuril/kg body weight and 100 mg iron (as gleptoferron complex)/kg body weight, which is a dose volume of 0.55 ml/kg body weight.
Maltese: Il-prodott mediċinali veterinarju għandu jingħata lill-ħnienes bejn 48 u 72 siegħa wara t-twelid permezz ta' injezzjoni waħda ġol-muskoli ta' 20 mg toltrazuril/kg ta' piż tal-ġisem u 100 mg ħadid (bħala kumpless ta' gleptoferron)/kg ta' piż tal-ġisem, li huwa volum tad-doża ta' 0.55 mL/kg ta' piz tal-ġisem.
English: It is a constituent of haemoglobin and myoglobin and has a key role in enzymes, such as cytochromes, catalases, and peroxidases.
Maltese: Huwa kostitwent tal-emoglobina u l-mijoglobina, u għandu rwol kruċjali fl-enzimi, bħal ċitokromi, catalases, u peroxidases.
English: Hrvatska BAYER d.o.o.
Maltese: Bayer d.o.o.
English: Colourless silicone-coated glass Type II vials with chlorobutyl stoppers and aluminium caps containing 100 ml.
Maltese: Kunjetti tal-ħġieġ Tip II mingħajr kulur u miksija bis-silikon, b'tappijiet tal-chlorobutyl u għotjien tal aluminju li fihom 100 mL.
English: Meat and offal: 53 days.
Maltese: Laħam u ġewwieni tal-annimali: 53 jum.
English: Bayer Animal Health GmbH DE-51368 Leverkusen Germany
Maltese: Bayer Animal Health GmbH DE-51368 Leverkusen
English: After an overdose, iatrogenic poisoning may occur which may cause the following clinical signs: pale mucous membranes, haemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, oedema of the limbs, lameness, shock, liver damage, and death.
Maltese: Wara doża eċċessiva, jista' jseħħ avvelenament jatroġeniku li jista' jikkawża s-sinjali kliniċi li ġejjin: membrani mukużi pallidi, gastroenterite emorraġika, rimettar, takikardija, pressjoni baxxa, qtugħ ta' nifs, edima tad-dirgħajn/riġlejn, zappip, xokk, ħsara fil-fwied, u mewt.
English: Pack size: Cardboard box with 1 vial of 100 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 100 mL.
English: Poultry
Maltese: Tjur
English: After the 2nd or 3rd administration of 3 times the recommended dose, clinical signs were observed such as apathy, dyspnoea, elevated rectal temperatures, reddening of the skin, ataxia, and/or adverse events of the legs or joints (such as polyarthritis).
Maltese: Wara t-tieni jew it-tielet għoti ta' 3 darbiet aktar mid-doża rakkomandata, ġew osservati sinjali kliniċi bħal apatija, qtugħ ta' nifs, żieda fit-temperaturi tar-rektum, ħmura tal-ġilda, atassja u/jew episodji avversi tas-saqajn jew il-ġogi (bħal poli-artrite).
English: Neonatal piglets may experience clinical signs similar to those due to coccidiosis (such as diarrhoea) for numerous reasons (e.g. other pathogens, stress).
Maltese: Ħnienes tat-twelid jistgħu jesperjenzaw sinjali kliniċi simili għal dawk ikkawżati mill-koċċidjożi (bħal dijarea) għal diversi raġunijiet (eż. patoġeni oħrajn, stress).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml +182 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)
Maltese: VETERINARJU Baycox Iron 36 mg/mL + 182 mg/mL suspensjoni għall-injezzjoni għall-ħnienes toltrazuril / ħadid (III) (bħala gleptoferron)
English: Transferrin-iron saturation levels may lead to increased susceptibility for (systemic) bacterial infection, pain, inflammatory reactions as well as abscess formation at the injection site.
Maltese: Il-livelli ta' saturazzjoni ta' transferrin-iron jistgħu jwasslu għal żieda fis-suxxettibilità għal infezzjoni batterjali (sistemika), uġigħ, reazzjonijiet infjammatorji kif ukoll formazzjoni ta' axxess fis-sit tal injezzjoni.
English: It has coccidiocidal activity against all intracellular development stages of the genus Cystoisospora, that is, merogony (asexual multiplication) and gamogony (sexual phase).
Maltese: Għandu attività koċċidjoċidali kontra l-istadji ta' żvilupp intraċellulari kollha tal-ġeneru Cystoisospora, jiġifieri, merogony (multiplikazzjoni asesswali) u gamogony (fażi sesswali).
English: Toltrazuril-sulfone is eliminated from plasma with a half-life of about 5 to 7 days.
Maltese: Toltrazurilsulfone jiġi eliminat mill-plażma b'half-life ta' madwar 5 sa 7 ijiem.
English: The iron (III)-ions are stored as ferritin in the main storage organs (e.g. liver, spleen and the reticuloendothelial system), and iron elimination does not play a quantitatively important role.
Maltese: Il-joni tal-ħadid (III) jinħażnu bħala ferritin fl-organi tal-ħażna ewlenin (eż. fwied, milsa u s-sistema retikuloendoteljali), u l-eliminazzjoni tal-ħadid m'għandhiex rwol importanti b'mod kwantitattiv.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets
Maltese: VETERINARJU Baycox Iron 36 mg/mL + 182 mg/mL suspensjoni għall-injezzjoni għall-ħnienes
English: A single intramuscular administration of 5 times the recommended dose, or 3 administrations of the recommended dose, did not cause systemic adverse effects or abnormalities in local injection site observations.
Maltese: Għoti ta' darba ġol-muskoli ta' 5 darbiet aktar mid-doża rakkomandata, jew 3 għotjiet tad-doża rakkomandata, ma kkawżawx effetti sistemiċi avversi jew osservazzjonijiet ta' anormalitajiet fis-sit tal-injezzjoni lokali.
English: MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH D-51368 Leverkusen
Maltese: Bayer Animal Health GmbH D-51368 Leverkusen
English: Introduce the needle at an angle of 90° and inject the product.
Maltese: Daħħal il-labra b'angolu ta' 90° u injetta lprodott.
English: PACKAGE LEAFLET: Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets
Maltese: Baycox Iron 36 mg/mL + 182 mg/mL suspensjoni għall-injezzjoni għall-ħnienes
English: Accidental self-injection may cause adverse effects.
Maltese: Injezzjoni bi żball lilek innifsek tista' tikkawża effetti avversi.
English: In the blood, free iron (III)-ions bind to transferrin (transport form) and are mainly used for the synthesis of haemoglobin.
Maltese: ħielsa jintrabtu ma' transferrin (forma ta' trasport) u jintużaw primarjament għas-sintesi talemoglobina.
English: Pigs (piglets 48 to 72 hours after birth).
Maltese: Ħnieżer (ħnienes 48 sa 72 siegħa wara t-twelid).
English: Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.
Maltese: Ġew irrappurtati mwiet fi ħnienes li ġew attribwiti għal żieda fis-suxxettibilità għall-infezzjoni minħabba imblukkar temporanju tas-sistema retikuloendoteljali.
English: After a single intramuscular injection of the recommended dose rate of 20 mg toltrazuril per kg body weight to piglets, toltrazuril plasma pharmacokinetics are characterised by biological variability.
Maltese: .2 Tagħrif farmakokinetiku Wara injezzjoni waħda ġol-muskoli bir-rata tad-doża rakkomandata ta' 20 mg toltrazuril għal kull kg ta' piż tal-ġisem lill-ħnienes, il-farmakokinetika fil-plażma ta' toltrazuril hija kkaratterizzata minn varjabilità bijoloġika.
English: 5 mg Slightly viscous dark brown suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and label after “EXP”.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq il-kartuna u t-tikketta wara “JIS”.
English: People with known hypersensitivity to iron (as gleptoferron complex) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għall-ħadid (bħala kumpless ta' gleptoferron) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg, as the efficacy and safety of the product has not been evaluated in such small piglets.
Maltese: Mhux rakkomandat li tuża l-prodott mediċinali veterinarju fi ħnienes li jiżnu inqas minn 0.9 kg, għax l-effikaċja u s-sigurtà tal-prodott għadhom ma ġewx evalwati fi ħnienes daqshekk żgħar.
English: Raamsdonksveer
Maltese: IL-PROVVISTA
English: The product is not recommended for use in piglets weighing less than 0.9 kg.
Maltese: Il-prodott mhux rakkomandat għall-użu fi ħnienes li jiżnu inqas minn 0.9 kg.
English: Frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Maltese: Użu frekwenti u ripetut ta' sustanzi kontra l-protożoa li ġejjin mill-istess klassi jista' jwassal għalliżvilupp ta' reżistenza.
English: Sos.
Maltese: бул.
English: Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
Maltese: Tużax fi ħnienes suspettati li qed isofru minn nuqqas ta' vitamina E u/jew selenju.
English: The rubber stopper of the vial may be safely punctured up to 30 times.
Maltese: It-tapp tal-lastku tal-kunjett jista' jittaqqab b'mod sigur sa 30 darba.
English: Marker residue
Maltese: Tessuti mmirati
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: Nru 37/2010 jew 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: Pharmacotherapeutic groups: Toltrazuril, combinations ATCvet code: QP51AJ51
Maltese: QP51AJ51
English: Wash hands after use and/or spillage.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: The tolerance of the veterinary medicinal product has been assessed after a single intramuscular administration of up to 5 times the recommended dose, as well as after repeated administrations.
Maltese: It-tolleranza għall-prodott mediċinali veterinarju ġiet evalwata wara għoti ta' darba ġol-muskoli sa 5 darbiet aktar mid-doża rakkomandata, kif ukoll wara għotjiet ripetuti.
English: For porcine species the fat MRL relates to ‘skin and fat in natural proportions'.
Maltese: ‘ġilda u xaħam fi proporzjonijiet naturali'.
English: • transparency and interaction with stakeholders;
Maltese: • trasparenza u interazzjoni mal-partijiet interessati;
English: • availability of medicines.
Maltese: • disponibbiltà tal-mediċini.