FrancophonIA/ELRC3.0 huggingface dataset:
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Maltese: Hemm xi evidenza ta' żieda fir-riskju ta' pulmonite ma' żieda fid-doża ta' sterojdi iżda dan ma ntweriex b'mod konklussiv fl-istudji kollha.
English: • fever or chills
Maltese: Fuljett ta' tagħrif
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Maltese: Żieda fl-inċidenza ta' pulmonite, li tinkludi pulmonite li tkun teħtieġ rikoveru l-isptar, ġiet osservata f'pazjenti b'COPD li jkunu qed jirċievu kortikosterojdi li jinġibdu man-nifs.
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Pulmonite f'pazjenti b'COPD
English: 29 March 2017
Maltese: 29 ta' Marzu 2017
English: 31 July 2015
Maltese: 31 ta' Lulju 2015
English: 28 January 2017
Maltese: 28 ta' Jannar 2017
English: December 2016 CMDh meeting
Maltese: Laqgħa tas-CMDh ta' Diċembru 2016
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint survey drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0005), complies with their obligation to conduct a database drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Maltese: Ir-rapport tal-istudju finali dwar l-utilizzazzjoni tal-mediċina fid-database konġunt sottomess millMAHs, flimkien mar-rapport tal-istudju finali dwar l-utilizzazzjoni tal-mediċina tal-istħarriġ konġunt sottomess mill-MAHs bħala proċedura separata (EMEA/H/N/PSR/J/0005), hu konformi mal-obbligu tagħhom biex iwettqu studju dwar l-utilizzazzjoni tal-mediċina fid-database biex jikkaratterizzaw ilprattiċi tal-għoti tar-riċetta għall-prodott mediċinali matul l-użu tipiku u kliniku fi gruppi rappreżentattivi ta' dawk li jagħtu riċetta, u biex jevalwaw ir-raġuni ewlenija għar-riċetta kif imposti matul il-proċedura ta' Artikolu 107i EMA/H/A-107i/1357 għal prodotti li fihom cyproterone/ethinylestradiol.
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-pożizzjonimill-Istati Membri (sottomissjoni tal-varjazzjoni mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq):
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the scientific conclusions are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC għar-rapport finali PASS mhux intervenzjonali impost għall-prodott(i) mediċinali li fihom is-sustanza attiva cyproterone/ethinylestradiol u kkonċernat bir-rapport finali
English: Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Maltese: Anness I Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni għat-termini talAwtorizzazzjoni(jiet) għat-Tqegħid fis-Suq
English: Annex II Conditions to the Marketing Authorisation(s)
Maltese: Anness II Kundizzjonijiet għall-Awtorizzazzjoni(jiet) għat-Tqegħid fis-Suq
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0005), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Maltese: Għalhekk, abbażi tad-dejta disponibbli dwar ir-rapport tal-istudju finali dwar id-database konġunta talutilizzazzjoni tal-mediċina fid-database konġunta, flimkien mar-rapport tal-istudju finali dwar lutilizzazzjoni tal-mediċina fid-database konġunta sottomess bħala proċedura separata (EMEA/H/N/PSR/J/0005), il-PRAC ikkunsidra li l-bidliet fil-kundizzjonijiet tal-awtorizzazzjoni għattqegħid fis-suq kienu ġġustifikati.
English: It is available as triangular chewable tablets, in five different strengths (6, 20, 30, 75 and 95 mg).
Maltese: Huwa disponibbli bħala pilloli triangulari li jintmagħdu, f'ħames qawwiet differenti (6, 20, 30, 75 u 95 mg).
English: It works by blocking an enzyme called cyclo oxygenase 2 (COX 2).
Maltese: Hija taħdem billi timblokka enzima msejjħa cyclo oxygenase 2 (COX 2).
English: This summary was last updated in: 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2013.
English: The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non steroidal antiinflammatory drugs (NSAIDs).
Maltese: Is-sustanza attiva fi Trocoxil, mavacoxib, tappartieni għall-klassi ta' mediċini msejħin non steroidal anti-inflammatory drugs (mediċini mhux sterojdi anti-infjammatorji - NSAIDs).
English: The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems.
Maltese: L-effetti sekondarji ta' Trocoxil huma simili għal dawk li dehru b'mediċini oħrajn f'din il-klassi ta' prodotti (NSAIDs) u jinkludu nuqqas ta' aptit, ippurgar artab/dijarea, rimettar, apatija (nuqqas ta' interess fil-madwar) u sinjali ta' problemi fil-kliewi.
English: Other information about Trocoxil:
Maltese: Informazzjoni oħra dwar Trocoxil:
English: Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti inflammatory action.
Maltese: Trocoxil fih is-sustanza attiva mavacoxib, li tappartieni għall-klassi ta' mediċini b'azzjoni antiinfjammatorja.
English: What is Trocoxil?
Maltese: X'inhu Trocoxil?
English: The product was shown to be comparable to the reference product (carprofen).
Maltese: Il-prodott intwera li huwa komparabbli mal-prodott ta' referenza (carprofen)..
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tal-CVMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Trocoxil must not be used in dogs aged less than one year or weighing less than 5 kg.
Maltese: Trocoxil m'għandux jintuża fi klieb ta' età inqas minn sena jew li jiżnu inqas minn 5 kg.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trocoxil exceed the risks for the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated, and recommended that Trocoxil be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Trocoxil jisbqu r-riskji għall-kura ta' uġigħ u infjammazzjoni assoċjati ma' mard deġenerattiv fil-klieb f'każijiet fejn kura kontinwa li taqbeż xahar hija indikata, u rrakkomanda li Trocoxil jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Maltese: Din l-enzima hija involuta fil-produzzjoni ta' sustanzi msejħin prostaglandins, li huma involuti fl-uġigħ u fl-infjammazzjoni.
English: Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog's main meal.
Maltese: Trocoxil jingħata f'doża ta' 2 mg għal kull kilogramma tal-piż korporali, immedjatament qabel jew malikla prinċipali tal-kelb.
English: Why has Trocoxil been approved?
Maltese: Għaliex ġie approvat Trocoxil?
English: Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Maltese: Trocoxil ġie studjat f'annimali tal-laboratorju, kif ukoll fi klieb li kienu kkurati f'diversi prattiċi veterinarji u kliniċi madwar l-Ewropa (“studji kliniċi”).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR).
English: What is the risk associated with Trocoxil?
Maltese: X'inhu r-riskju assoċjat ma' Trocoxil?
English: It must also not be used in dogs that are hypersensitive (allergic) to mavacoxib, any of the other ingredients in the tablet or sulphonamides.
Maltese: M'għandux jintuża fi klieb li huma sensittivi żżejjed (allerġiċi) għal mavacoxib, xi sustanzi oħrajn fil-pillola jew għas-sulphonamides.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil on 09/09/2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni fuq is-suq madwar l-Unjoni Ewropea, għal Trocoxil fi 9/09/2008.
English: How does Trocoxil work?
Maltese: Għalxiex jintuża Trocoxil?
English: How has Trocoxil been studied?
Maltese: Kif ġie studjat Trocoxil?
English: Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs' owners.
Maltese: Ilmediċina tqabblet ma' carprofen (NSAID ieħor) għal mhux aktar minn 6.5 xhur u l-effetti ta' kura fit-tul ġew studjati wkoll.
English: Trocoxil tablets for dogs improved pain relief and inflammation.
Maltese: Trocoxil pilloli li jintmagħdu għall-klieb kienu studjati fi studju wieħed ewlieni fi klieb bl-osteoartrite.
English: _ _ 1 25 mg rilpivirine (as hydrochloride) / 200 mg emtricitabine / 245 mg tenofovir disoproxil (as fumarate)
Maltese: Flixkun (HDPE) 3 x 30 pillola _ _ 1 25 mg rilpivirine (bħala hydrochloride) / 200 mg emtricitabine / 245 mg tenofovir disoproxil (bħala fumarate)
English: EU Number
Maltese: Numru tal-EU
English: 3 x 30 tablets
Maltese: Flixkun (HDPE) 30 pillola
English: The application was withdrawn before ‘day 120'.
Maltese: L-applikazzjoni kienet irtirata qabel ‘jum 120'.
English: EMEA/H/C/002019
Maltese: 20 ta' Jannar 2011 EMA/40202/2011 EMEA/H/C/002019
English: The active substance in Ozespa, briakinumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Ozespa, briakinumab, hija antikorp monoklonali.
English: What is Ozespa?
Maltese: X'inhu Ozespa?
English: Briakinumab was designed to attach to a part of two ‘cytokines' (messenger molecules) in the immune system called interleukin-12 and interleukin-23.
Maltese: Briakinumab huwa kapaċi biex jeħel ma' parti ta' żewġ ‘ċitokini' (molekuli messaġġiera) fis-sistema immuni magħrufa bħala interleukin-12 u interleukin-23.
English: What consequences does this withdrawal have for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar għal pazjenti fi provi kliniċi?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li huwa kapaċi jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġen) fil-ġisem.
English: was the application when it was withdrawn?
Maltese: Sa fejn waslet l-evalwazzjoni tal-applikazzjoni qabel ma din ġiet irtirata?
English: The effects of Ozespa were first tested in experimental models before being stud The company presented the results of four main studies in 2,479 adults with psor compared with placebo (a dummy treatment), etanercept and methotrexate (o treat p effectiveness was the change in the symptom scores, as measured using two sta
Maltese: Il-kumpanija ppreżentat ir-riżultat ta' erba' studji ewlenin fuq 2,479 adult bi psorjażi.
English: Ozespa was expected to be used to treat moderate to severe plaque psoriasis respond to or cannot use other systemic (whole-body) treatments for psorias methotrexate and PUVA (psoralen ultraviolet-A).
Maltese: Ozespa kien mistenni li jintuża biex jikkura psorjażi bi plakka moderata sa severa f'adulti li jkunu naqqsu milli jirrispondu għal, jew li ma jistgħux jużaw kura sistemika oħra (fuq il-ġisem kollu) għal psorjażi, inkluż ciclosporin, methotrexate u PUVA (psoralen ultraviolet-A).
English: What was Ozespa expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Ozespa?
English: tive substance briakinumab.
Maltese: Ozespa huwa mediċina li fiha s-sustanza attiva briakinumab.
English: Ozespa (briakinumab)
Maltese: Mistoqsijiet u tweġibiet
English: Two of the studies lasted 12 weeks, and two lasted 52 weeks.
Maltese: Tnejn mill-istudji damu għaddejjin 12-il ġimgħa, u tnejn damu għaddejjin 52 ġimgħa.
English: How is Ozespa expected to work?
Maltese: Kif huwa mistenni li jaħdem Ozespa?
English: Ozespa was ther medicines used to soriasis).
Maltese: Ozespa tqabbel ma' plaċebo (kura finta), etanercept u methotrexate (mediċini oħra wżati fil-kura ta' psorjażi).
English: By attaching to them, briakinumab was expected to block their activity, thereby reducing the activity of the immune system and the symptoms of the disease.
Maltese: Meta jeħel magħhom, briakinumab kien mistenni li jimblokka l-attività tagħhom, u b'hekk inaqqas l-attività tassistema immuni u s-sintomi tal-marda.
English: * PU: Potency Units
Maltese: * PU: Unitajiet tal-Potenza
English: ATCvet code: QI01AD09
Maltese: Kodiċi ATC veterinarja QI01AD09
English: EU/2/19/245/001 (10 x 1,000 doses) EU/2/19/245/002 (10 x 2,000 doses) EU/2/19/245/003 (10 x 2,500 doses) EU/2/19/245/004 (10 x 4,000 doses) EU/2/19/245/005 (10 x 5,000 doses)
Maltese: EU/2/19/245/001 (10 x 1000 doża) EU/2/19/245/002 (10 x 2000 doża) EU/2/19/245/003 (10 x 2500 doża) EU/2/19/245/004 (10 x 4000 doża)
English: In ovo or SC use.
Maltese: Użu in ovo jew SC.
English: Hipra Italia S.r.l.
Maltese: Italia S.r.l.
English: Ελλάδα HIPRA EΛΛAΣ A.E.
Maltese: HIPRA EΛΛAΣ A.E.
English: Date of first authorisation: 12/11/2019
Maltese: Data tal-ewwel awtorizzazzjoni: 12/11/2019
English: Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Spain
Maltese: Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Spanja
English: Solvent for GUMBOHATCH
Maltese: VETERINARJU Solvent għal GUMBOHATCH
English: Onset of immunity: from 24 days of age.
Maltese: Bidu tal-immunità: minn età ta' 24 jum.
English: 1,000 doses 2,000 doses 2,500 doses 4,000 doses 5,000 doses
Maltese: 1000 doża 2000 doża 2500 doża 4000 doża 5000 doża
English: 17170 Amer (Girona) SPAIN
Maltese: 17170 Amer (Girona) SPANJA
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 25°C.
English: 10 x 1,000 doses 10 x 2,000 doses 10 x 2,500 doses 10 x 4,000 doses 10 x 5,000 doses
Maltese: 10 x 2000 doża. 10 x 2500 doża. 10 x 4000 doża. 10 x 5000 doża.
English: Solvent: Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Maltese: Boroż tal-polypropylene li fihom 200 ml, 400 ml, 800 ml jew 1,000 ml.
English: Duration of immunity: up to 43 days of age.
Maltese: Kemm iddum l-immunità: sa età ta' 43 jum.
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: - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
Maltese: Immunoloġiċi għal avi, tiġieġ domestiku, vaċċini virali ħajjin, virus tal marda bursali infettiva tat-tjur (marda ta' Gumboro).
English: Amer 17170 (Girona)
Maltese: Amer 17170 (Girona) Spanja
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva
English: IBDV-specific antibody solution…………………………….. 2.7x106 VNU** of IgY per vial **VNU: Virus Neutralisation Units
Maltese: Soluzzjoni tal-antikorp speċifika għal IBDV………………..2.7x106 VNUs** ta' IgY f'kull kunjett ** VNU: Unitajiet ta' Newtralizzazzoni tal-Virus
English: Laboratorios Hipra, S.A. Avda.
Maltese: LABORATORIOS HIPRA, S.A.
English: For in ovo administration:
Maltese: U METODU TA' AMMINISTRAZZJONI Pożoloġija:
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052….. 10
Maltese: Virus tal-marda bursali infettiva attenwat ħaj (IBDV), razza 1052……….. 10
English: Lyophilisate:
Maltese: Pożoloġija:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanzi attivi, minħabba li huma prinċipji ta' oriġini bijoloġika maħsubin sabiex jipproduċu immunità attiva ma humiex regolati bir-Regolament (KE) 470/2009.
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052……….. 101.48 - 102.63 PU* * PU: Potency Units
Maltese: Virus tal-marda bursali infettiva attenwat ħaj (IBDV), razza 1052…………….. 101.48 - 102.63 PU* * PU: Unitajiet tal-Potenza
English: Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
Maltese: Kunjetti tal-ħġieġ tat-Tip 1 magħluqa b'tappijiet tal-bromobutil tat-Tip 1 u ssiġillati b'għotjien talaluminju li fihom 1,000 doża, 2,000 doża, 2,500 doża, 4,000 doża jew 5,000 doża tal-vaċċin imnixxef bil-friża.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (solvent bags)
Maltese: Kaxex tal-kartun (boroż tas-solvent)
English: Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-lijofiliżat li fihom 2,500 doża.
English: Package sizes:
Maltese: Daqsijiet tal-pakkett:
English: la Selva, 135 Amer, 17170 Girona Spain
Maltese: Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 Girona Spanja
English: Cardboard box with 10 bags containing 1,000 ml solvent.
Maltese: Kaxxa tal-kartun b'10 boroż li fihom 1,000 ml solvent.
English: <Batch><Lot> {number}
Maltese: B'MOD KORRETT
English: The excipients (including adjuvants) 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 (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of bursa of Fabricius caused by very virulent avian infectious bursal disease virus infection.
Maltese: Għal immunizzazzjoni attiva ta' flieles tas-simna ta' età ta' jum wieħed u bajd tat-tiġieġ tas-simna ngallat biex inaqqas is-sinjali kliniċi u leżjonijiet tal-bursa ta' Fabricius ikkawżati minn infezzjoni tal virus tal-marda bursali infettiva tat-tjur virulenti ħafna.
English: The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.
Maltese: Il-vaċċin (doża ta' 0.05 ml) għandu jiġi injettat fil-borża amnijotika ta' bajd tat-tiġieġ tas-simna ngallat ta' 18-il jum.
English: la Selva, 135 Amer, 17170 (Girona) Spain
Maltese: Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 (Girona) Spain
English: Cardboard box with 10 bags containing 800 ml solvent.
Maltese: Kaxxa tal-kartun b'10 boroż li fihom 800 ml solvent.
English: Cardboard box with 10 bags containing 200 ml solvent.
Maltese: Kaxxa tal-kartun b'10 boroż li fihom 200 ml solvent.
English: Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
Maltese: Laħlaħ il-kunjett b'2 ml oħra tas-solvent/sospensjoni tal-lijofiliżat miksuba fil-pass 1, u injettaha lura fil-borża tas-solvent.
English: Cardboard box with 10 bags containing 400 ml solvent.
Maltese: Kaxxa tal-kartun b'10 boroż li fihom 400 ml solvent.
English: Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
Maltese: Irrepeti pass 2 biex tiżgura li l-lijofiliżat kollu ġie ttrasferit fil-borża tas-solvent.
English: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
Maltese: VETERINARJU GUMBOHATCH lijofiliżat u solvent għal sospensjoni għall-injezzjoni għat-tiġieġ
English: Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-lijofiliżat li fihom 1,000 doża.
English: Avda.
Maltese: Hipra
English: GUMBOHATCH lyophilisate for suspension for injection for chickens
Maltese: VETERINARJU GUMBOHATCH lijofiliżat għal sospensjoni għall-injezzjoni għat-tiġieġ
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052 …….. 101.48 - 102.63 PU* * PU: Potency Units
Maltese: Virus tal-marda bursali infettiva attenwat ħaj (IBDV), razza 1052…….. 101.48 - 102.63 PU*
English: To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
Maltese: Biex jistimula l-immunità attiva kontra virusijiet tal-marda bursali virulenti ħafna (marda ta' Gumboro) fit-tiġieġ tal-brojler.
English: Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Maltese: Kull doża (0.05 ml għal in ovo jew 0.2 ml għal SC) fiha:
English: HIPRA UK AND IRELAND, Ltd. Tel: +44-(0)11 5845 6486
Maltese: Tel: +44-(0)11 5845 6486
English: Dilutions for in ovo administration (0.05 ml per dose) Number and content of vaccine vials:
Maltese: Dilwizzjonijiet għal għoti in ovo (0.05 ml għal kull doża):
English: Cardboard box with 10 lyophilisate vials containing 5,000 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-lijofiliżat li fihom 5,000 doża.
English: Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-lijofiliżat li fihom 4,000 doża.
English: Lyophilisate and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Solvent għal sospensjoni għall-injezzjoni.
English: Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-lijofiliżat li fihom 2,000 doża.
English: In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
Maltese: Fi studji tal-laboratorju, it-tnaqqis tal-limfoċiti kien komuni ħafna, segwit minn ripopulazzjoni tallimfoċiti u riġenerazzjoni tal-bursa ta' Fabricius.
English: The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-prodott mediċinali veterinarju immunoloġiku meta jintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.