FrancophonIA/ELRC3.0 huggingface dataset:
English: It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale.
Maltese: Huwa indikat fit-tiġieġ biex inaqqas ilmortalità, il-morbidità, u s-sinjali kliniċi u biex inaqqas il-leżjonijiet minħabba Pasterellożi kkawżata minn Pasteurella multocida jew biex inaqqas il-morbidità u l-leżjonijiet f'infezzjonijiet respiratorji kkawżati minn Ornithobacterium rhinotracheale.
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu ta' Tiżmim
English: Package leaflet:
Maltese: FULJETT TAL-PAKKETT:
English: Following the CVMP opinion of 7 March 2013 recommending a 9 days withdrawal period for chicken meat and offal following a dose rate of 20 mg/kg body weight for 4 consecutive days, on 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a re-examination of the CVMP opinion.
Maltese: Wara l-opinjoni tas-CVMP tas-7 ta' Marzu 2013 li tirrakkomanda perjodu tal-irtirar ta' 9 ijiem għallaħam tat-tiġieġ u l-ġewwieni wara rata ta' doża ta' 20 mg/kg tal-piż tal-ġisem għal 4 ijiem konsekuttivi, fit-22 ta' Marzu 2013, Eurovet Animal Health BV innotifikat lill-Aġenzija bl-intenzjoni tagħhom li jitolbu eżami mill-ġdid tal-opinjoni tas-CVMP.
English: Residue depletion studies
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The CVMP assessed the detailed grounds for re-examination presented by Eurovet Animal Health BV related to formulation effects and bioequivalence claims, and also to the available residue depletion studies.
Maltese: Is-CVMP ivvaluta r-raġunijiet iddettaljati għall-eżami mill-ġdid ippreżentati minn Eurovet Animal Health BV relatati mal-effetti tal-formulazzjoni u d-dikjarazzjonijiet ta' bijoekwivalenza, u anki mal-istudji disponibbli dwar it-tnaqqis tar-residwi.
English: Name
Maltese: Ġermanja
English: • the CVMP on the basis of the available residue depletion data considered that a withdrawal period of 9 days should be established for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days; the CVMP recommended the granting of the variation to the terms of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC) in accordance with the recommended changes in the relevant sections of the product information as set out in Annex III.
Maltese: is-CVMP irrakkomanda l-għoti tal-varjazzjoni fit-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq għat-trab ta' 500 mg/g ta' Soludox għall-użu fl-ilma tax-xorb għall-majjali u t-tiġieġ (NL/V/0141/001/DC) u t-trab ta' 500 mg/g ta' Soludox għall-użu fl-ilma tax-xorb għall-majjali u ttiġieġ (UK/V/0349/001/DC) skont it-tibdil rakkomandat fis-sezzjonijiet rilevanti tal-informazzjoni dwar il-prodott kif stabbilit fl-Anness
English: The main shortcoming of the study was the use of a microbiological assay.
Maltese: In-nuqqas ewlieni tal-istudju kien l-użu ta' analiżi mikrobijoloġika.
English: After reviewing the documentation submitted by the MAH, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 7 March 2013, which recommended a withdrawal period of 9 days for chicken for the dose of 20 mg/kg bw for 4 consecutive days.
Maltese: Wara li rreveda d-dokumentazzjoni ppreżentata mill-MAH, is-CVMP ikkonkluda li ma kienx hemm biżżejjed raġunijiet xjentifiċi biex jirrevedi l-konklużjonijiet tiegħu tas-7 ta' Marzu 2013, li jirrakkomandaw perjodu tal-irtirar ta' 9 ijiem għat-tiġieġ għad-doża ta' 20 mg/kg tal-piż tal-ġisem għal 4 ijiem konsekuttivi.
English: Residue depletion data from a study conducted in 1993 have been provided.
Maltese: Ġiet ipprovduta dejta dwar it-tnaqqis tar-residwi minn studju li sar fl-1993.
English: The CVMP agreed that there is likely to be no significant difference in the solubility of the products on the market regardless of whether they contain tartaric acid or citric acid.
Maltese: Is-CVMP qabel li probabbilment m'hemmx differenza sinifikanti fis-solubbilità tal-prodotti fis-suq irrispettivament jekk fihomx l-aċidu tartariku jew l-aċidu ċitriku.
English: Labelling:
Maltese: Tiġieġ:
English: 5531 AE Bladel
Maltese: >0.05; Shapiro:
English: Re-examination procedure
Maltese: TALPRODOTTI MEDIĊINALI
English: One possibility which could partially explain this difference was argued to be the fact that in the 1999 study, the litter was not removed, leading to a recirculation of doxycycline through the natural pecking behaviour of the chickens.
Maltese: Possibbiltà waħda li tista' parzjalment tispjega din iddifferenza kienet argumentata li kienet il-fatt li fl-istudju tal-1999, il-mifrex ma kienx tneħħa, li wassal għar-riċirkolazzjoni ta' doxycycline permezz tal-imġiba naturali ta' tnaqqir li għandhom it-tiġieġ.
English: Residue depletion data from a study conducted in 2011 have been provided.
Maltese: Ġiet ipprovduta dejta dwar it-tnaqqis tar-residwi minn studju li sar fl-2011.
English: There are two authorised dosages: 10 mg/kg body weight for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg body weight for 4 consecutive days for which the withdrawal period is 12 days.
Maltese: Hemm żewġ dożaġġi awtorizzati: 10 mg/kg tal-piż talġisem għal 4 ijiem konsekuttivi, li għaliha l-perjodu tal-irtirar huwa ta' 3 ijiem, u 20 mg/kg tal-piż talġisem għal 4 ijiem konsekuttivi li għaliha l-perjodu tal-irtirar huwa ta' 12-il jum.
English: Moreover, these older studies are superseded if data derived using more up to date and more accurate analytical methods based on chromatography and mass spectroscopy are available.
Maltese: Barra minn hekk, dawn l-istudji l-aktar antiki jiġu sostitwiti jekk ikun hemm dejta disponibbli li tkun ġiet prodotta bl-użu ta' metodi analitiċi aktar aġġornati u preċiżi bbażati fuq kromatografija u spettroskopija tal-massa.
English: The marketing authorisation holder (MAH) Eurovet Animal Health BV, submitted an application for a type II variation to shorten the withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) Eurovet Animal Health BV, ippreżenta applikazzjoni għal varjazzjoni tat-tip II biex iqassar il-perjodu ta' tiżmim għal-laħam tat-tiġieġ u lġewwieni f'rata ta' doża ta' 20 mg/kg tal-piż tal-ġisem għal 4 ijiem konsekuttivi.
English: Benefit-risk assessment
Maltese: 3. Valutazzjoni tal-benefiċċju-riskju
English: Chickens: - Meat and offal: 9 days, following a dose rate of 20 mg/kg body weight for 4 days.
Maltese: - Laħam u interjuri: 9-il jum, wara rata ta' doża ta' 20 mg/kg piż tal-ġisem għal 4 ijiem.
English: Residue depletion data from a study conducted in 1999 have been provided.
Maltese: Ġiet ipprovduta dejta dwar it-tnaqqis tar-residwi minn studju li sar fl-1999.
English: In the opinion of the MAH the pH of the medicated drinking water solutions is mainly dependant on the quality of the water used, while the formulation of the powder, i.e. which acid is used as a stabiliser, has only a limited effect.
Maltese: Fil-fehma tal-MAH il-pH tas-soluzzjonijiet medikati tal-ilma tax-xorb jiddependi prinċipalment mill-kwalità tal-ilma użat, filwaqt li l-formulazzjoni tat-trab, jiġifieri liema aċidu jintuża bħala stabilizzatur, għandha effett limitat biss.
English: However, the apparent similarity of solubility within drinking water should not be understood as providing an argument for ruling out definitively a formulation effect due to the presence of tartaric acid.
Maltese: Madankollu, is-similarità apparenti tas-solubbilità fl-ilma tax-xorb m'għandhiex tinftiehem li tipprovdi argument biex jiġi definittivament eskluż effett tal-formulazzjoni minħabba l-preżenza tal-aċidu tartariku.
English: CVMP conclusions after the re-examination
Maltese: Konklużjonijiet tas-CVMP wara l-eżami mill-ġdid
English: The data from the 1999 study could be analysed using the statistical approach, leading to a withdrawal period of 12 days.
Maltese: Id-dejta mill-istudju tal-1999 setgħet tiġi analizzata permezz tal-approċċ statistiku, u dan wassal għal perjodu tal-irtirar ta' 12-il jum.
English: The MAH has provided data from three residue depletion studies.
Maltese: Il-MAH ipprovda dejta minn tliet studji dwar it-tnaqqis tar-residwi.
English: Determination of the withdrawal period for chicken for the dose of 20 mg/kg body weight for 4 consecutive days
Maltese: Determinazzjoni tal-perjodu tal-irtirar tat-tiġieġ għad-doża ta' 20 mg/kg tal-piż tal-ġisem għal 4 ijiem konsekuttivi
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008 has started on 20 August 2012.
Maltese: Din il-kwistjoni baqgħet mhux riżolta u għalhekk fl-20 ta' Awwissu 2012 bdiet proċedura tas-CMD(v) skont l-Artikolu 13(2) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: VETERINARJI, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MNEJN JINGĦATA, DETENTURI
English: The MAH argued that even though Soludox contains tartaric acid as a stabiliser while all other doxycycline powders contain citric acid, the solubility of all products is the same and hence the amount of active substance in the chicken's tissues would be the same.
Maltese: Il-MAH argumenta li anke jekk Soludox fih l-aċidu tartariku bħala stabilizzatur filwaqt li t-trabijiet l-oħra kollha ta' doxycycline fihom l-aċidu ċitriku, is-solubbilità tal prodotti kollha hija l-istess u għalhekk l-ammont tas-sustanza attiva fit-tessuti tat-tiġieġ sejjer ikun listess.
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names (see annex I) contains doxycycline hyclate as active ingredient.
Maltese: It-trab ta' 500 mg/g ta' Soludox għall-użu fl-ilma tax-xorb għall-majjali u t-tiġieġ u ismijiet assoċjati (ara l-anness I) fih doxycycline hyclate bħala sustanza attiva.
English: Doxycycline residue levels in muscle were below the muscle MRL from 5 days onwards.
Maltese: Il-livelli tar-residwi ta' doxycycline fil-muskoli kienu taħt lMRL għall-muskoli minn 5 ijiem 'il quddiem.
English: • the CVMP reviewed all available data submitted by the MAH, to support the withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days;
Maltese: • is-CVMP irreveda d-dejta kollha disponibbli ppreżentata mill-MAH, biex jappoġġja l-perjodu talirtirar għal-laħam tat-tiġieġ u l-ġewwieni f'rata ta' doża ta' 20 mg/kg tal-piż tal-ġisem għal 4 ijiem konsekuttivi;
English: The recommended dose is 150 mg (2 injections).
Maltese: Id-doża rakkomandata hija 150 mg (2 injezzjonijiet).
English: Further information on Skyrizi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Skyrizi.
Maltese: ema.europa.eu/medicines/human/EPAR/Skyrizi.
English: The active substance in Skyrizi, risankizumab, is a monoclonal antibody (a type of protein) that is designed to attach to interleukin 23 and block its activity.
Maltese: Is-sustanza attiva fi Skyrizi, ir-risankiżumab, hija antikorp monoklonali (tip ta' proteina) li hi mfassla biex teħel ma' interleukin 23 u timblokka l-attività tiegħu.
English: Other information about Skyrizi
Maltese: Informazzjoni oħra dwar Skyrizi
English: Interleukin 23 is a messenger molecule of the body's immune system (the body's natural defences) and is involved in causing inflammation that is linked to the formation of plaque psoriasis.
Maltese: Interleukin 23 huwa molekula messaġġier tas-sistema immunitarja tal-ġisem (id-difiżi naturali tal-ġisem) u huwa involut fl-ikkawżar ta' infjammazzjoni li hija marbuta mal-formazzjoni tal-psorijażi bil-qoxra.
English: In the third study involving 605 patients, after 16 weeks of treatment 72% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 47% of those receiving adalimumab.
Maltese: Fit-tielet studju li involva 605 pazjenti, wara 16-il ġimgħa ta' kura 72 % tal-pazjenti li ngħataw Skyrizi kellhom tnaqqis ta' minn tal-inqas 90 % fil-punteġġi PASI, meta mqabbla ma' 47 % ta' dawk li ngħataw adalimumab.
English: In the first two studies in a total of 997 patients, after 16 weeks of treatment around 75% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores (a measure of how severe and widespread the skin lesions are), compared with around 45% of those receiving ustekinumab and around 4% of those receiving placebo.
Maltese: Fl-ewwel żewġ studji f'total ta' 997 pazjent, wara 16-il ġimgħa ta' kura madwar 75 % tal-pazjenti li ngħataw Skyrizi kellhom tnaqqis ta' minn tal-inqas 90 % fil-punteġġi PASI (kejl ta' kemm il-leżjonijiet tal-ġilda huma severi u mifruxa), meta mqabbla ma' madwar 45 % ta' dawk li ngħataw ustekinumab u madwar 4 % ta' dawk li ngħataw plaċebo.
English: In 4 main studies involving over 2,100 patients with moderate to severe disease who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.
Maltese: F'4 studji ewlenin li involvew aktar minn 2,100 pazjent b'marda moderata sa severa li kellhom bżonn kura sistemika, Skyrizi kien aktar effettiv minn plaċebo (kura finta) u mediċini komparaturi fit-titjib tas-sintomi.
English: Skyrizi contains the active substance risankizumab.
Maltese: Skyrizi fih is-sustanza attiva risankiżumab.
English: Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.
Maltese: It-titjib fis-sintomi baqa' hemm wara 52 ġimgħa ta' kura bi Skyrizi.
English: What are the risks associated with Skyrizi?
Maltese: X'inhuma r-riskji assoċjati ma' Skyrizi?
English: Finally, in the fourth study involving 507 patients, after 16 weeks of treatment 73% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 2% of those receiving placebo.
Maltese: Fl-aħħar nett, fir-raba' studju li involva 507 pazjenti, wara 16-il ġimgħa ta' kura, 73 % tal-pazjenti li ngħataw Skyrizi kellhom tnaqqis ta' minn tal-inqas 90 % fil-punteġġi PASI, meta mqabbla ma' 2 % ta' dawk li rċevew plaċebo.
English: There are few side effects, the most important one being infection.
Maltese: Hemm xi ftit effetti sekondarji, u l-aktar wieħed importanti huwa infezzjoni.
English: As for all medicines, data on the use of Skyrizi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Skyrizi hija ssorveljata kontinwament.
English: How does Skyrizi work?
Maltese: Kif jintuża Skyrizi?
English: It is used in adults with moderate to severe disease and who require systemic treatment (treatment with medicines given by mouth or by injection).
Maltese: Dan jintuża f'adulti b'marda minn moderata sa severa u li jkunu jeħtieġu kura sistemika (kura b'mediċini mogħtija oralment jew b'injezzjoni).
English: By blocking the action of interleukin 23, risankizumab reduces inflammation and symptoms associated with the disease.
Maltese: Billi timblokka l-azzjoni ta' interleukin 23, ir-risankiżumab tnaqqas l-infjammazzjoni u s-sintomi assoċjati mal-marda.
English: In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi.
Maltese: Fit-tieni parti ta' dan l-istudju, xi pazjenti li l-ewwel ingħataw Skyrizi mbagħad inqalbu għal plaċebo wara 28 ġimgħa filwaqt li oħrajn baqgħu fuq Skyrizi.
English: For the full list of side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: The doctor may decide to stop treatment if the condition does not improve after 16 weeks.
Maltese: It-tabib jista' jiddeċiedi li jwaqqaf il-kura jekk il-kondizzjoni ma titjiebx wara 16-il ġimgħa.
English: In addition, 84% of patients receiving Skyrizi had clear or almost clear skin, compared with 60% of those receiving adalimumab.
Maltese: Barra minn hekk, 84 % tal-pazjenti li ngħataw Skyrizi kellhom ġilda ċara jew kważi ċara, meta mqabbla ma' 60 % ta' dawk li ngħataw adalimumab.
English: It is injected under the skin in an area that is clear of psoriasis, usually in the thighs or belly.
Maltese: Jiġi injettat taħt il-ġilda f'żona li fiha m'hemmx psorijażi, normalment fil-koxox jew fiż-żaqq.
English: In addition, around 86% of patients receiving Skyrizi had clear or almost clear skin, compared with around 62% of those receiving ustekinumab and around 6% of those receiving placebo.
Maltese: Barra minn hekk, madwar 86 % tal-pazjenti li ngħataw Skyrizi kellhom ġilda ċara jew kważi ċara meta mqabbla ma' madwar 62 % ta' dawk li ngħataw ustekinumab u madwar 6 % ta' dawk li ngħataw plaċebo.
English: Side effects reported with Skyrizi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Skyrizi huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: MA (EU) number
Maltese: Numru ta' l-EU Numru tal-MA
English: ATC vet code: QI07AD04.
Maltese: QI07AD04.
English: Date of last renewal: 27/03/2019.
Maltese: Data tal-aħħar tiġdid: 27/03/2019.
English: Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC
Maltese: Komenského 212, 683 23 Ivanovice na Hané, IR-REPUBBLIKA ĊEKA
English: Duration of immunity:
Maltese: Tul tal-immunità:
English: * Tissue culture infectious dose 50%.
Maltese: * 50% doża infettiva tat-tessut ikkultivat.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04/07/2014.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04/07/2014.
English: Canine distemper virus, strain CDV Bio 11/A
Maltese: Canine distemper virus, strejn CDV Bio 11/A
English: Onset of immunity:
Maltese: Bidu tal-immunità:
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 wieħed f'10 annimali ttrattati juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Canine adenovirus Type 2
Maltese: Canine adenovirus tip 2
English: Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
Maltese: Reazzjonijiet ipersensittivi (eż. sinjali gastrointestinali bħal dijarea u remettar, anafilassi, anġoedima, dispneja, xokk ċirkolatorju, kollass) rari jseħħu.
English: Minimum Maximum
Maltese: Minimu
English: Canine parvovirus Type 2b
Maltese: Canine parvovirus tip 2b
English: Dosage and route of administration:
Maltese: Doża u metodu ta' amministrazzjoni:
English: Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Maltese: Trometamol Edetic acid
English: Solve nt: Water for injections (Aqua ad iniectabilia)
Maltese: Ilma għall-injezzjonijiet (Aqua ad iniectabilia)
English: VIAL (1 ML SOLVENT)
Maltese: KUNJETT (SOLVENT 1 ML) ISEM
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/169/001
Maltese: FIS-SUQ EU/2/14/169/001
English: First dose: Versican Plus DHPPi from 8-9 weeks of age.
Maltese: L-ewwel doża: Versican Plus DHPPi minn età ta' 8-9 ġimgħat.
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Maltese: Zoetis Belgium SA Rue Laid Burniat 1
English: Canine parainfluenza Type 2 virus
Maltese: Canine parainfluenza virus tip 2
English: The duration of immunity against CAV-2 was not established by challenge.
Maltese: It-tul tal-immunità għall-CAV-2 ma ġiex stabbilit permezz ta' sfida.
English: The visual appearance is as follows:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
Maltese: Canine parvovirus tip 2b, strejn CPV-2b-Bio 12/B
English: PACKAGE SIZE 25 x 1 dose
Maltese: 25 x doża waħda 50 x doża waħda
English: Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of solvent.
Maltese: Kaxxa tal-plastik b'25 kunjett (doża waħda) tal-lijofiliżat u 25 kunjett (1 ml) tas-solvent.
English: Canine adenovirus Type 2, strain CAV-2 Bio 13
Maltese: Canine adenovirus tip 2, strejn CAV-2-Bio 13
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Maltese: Tal-anqas tliet snin wara l- kors ta' tilqim primarju għall-canine distemper virus, canine adenovirus tip 1, canine adenovirus tip 2 u canine parvo virus.
English: Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of solvent.
Maltese: Kaxxa tal-plastik b'50 kunjett (doża waħda) tal-lijofiliżat u 50 kunjett (1 ml) tas-solvent.
English: − 3 weeks after the first vaccination for CDV, CAV, CPV, and
Maltese: − 3 ġimgħat wara l-ewwel tilqima għal CDV, CAV, CPV, u
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Maltese: Canine parainfluenza virus tip 2, strejn CPiV-2 Bio 15
English: Lyophilisate (live attenuated):
Maltese: Lijofiliżat (attenwat ħaj):
English: Rabies:
Maltese: Lijofiliżat:
English: Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years.
Maltese: Rispons immunitarju protettiv għal mard respiratorju assoċċjat mal-CAV-2 huwa kkunsidrat li jdum tal-anqas tliet snin.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus Types 1 and 2, and canine parainfluenza virus.
Maltese: It-tilqima hija intenzjonata għall-immunizzazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-virus tal-canine distemper, mill-canine parvovirus, mill-canine adenovirus tipi 1 u 2, u mill-canine parainfluenza.
English: − to prevent mortality and clinical signs caused by canine distemper virus,
Maltese: − biex tilqa' għal mortalità u sinjali kliniċi kkawżati mill-canine distemper virus,
English: − 3 weeks after completion of the primary course for CPiV.
Maltese: − 3 ġimgħat wara li jintemm il-kors primarju għal CpiV.
English: A good immune response is reliant on a fully competent immune system.
Maltese: Rispons immunitarju tajjeb jiddependi fuq sistema immunitarja kompletament kompetenti.
English: Type I glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml solvent magħluq b'tapp tal-lastiku chlorobutyl u kappa tal-aluminju.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Aqua ad iniectabilia
Maltese: Aqua ad iniectabilia
English: − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, and
Maltese: − biex tilqa' għas-sinjali kliniċi, lewkopinja u tixrid virali kkawżati mill-canine parvo virus, u
English: However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Maltese: Mandankollu, f'field studies 10% ta' klieb sero-negattivi ma wrewx konverżjoni seroloġika (> 0.1