FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Maltese: Wara r-rikostituzzjoni b'2.5 ml ta' Ilma għall-Injezzjonijiet kull ml fih 2 mg ta' Drotrecogen alfa (attivat)
English: NAME OF THE MEDICINAL PRODUCT Xigris 20 mg powder for solution for infusion drotrecogin alfa (activated)
Maltese: Xigris 20 mg trab għal soluzzjoni għall-infużjoni Drotrecogin alfa (attivat)
English: Investigators attributed 2 deaths in the Xigris group and 5 deaths in the placebo group to bleeding events.
Maltese: L-investigaturi attribwew 2 imwiet fil-grupp Xigris u 5 imwiet fil-grupp plaċebo għal każi ta' fsada.
English: Serious bleeding events during the 28-day study period In PROWESS, the incidence of serious bleeding events during the 28-day study period was 3.5% and 2.0% in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Maltese: Fi PROWESS, l-inċidenza ta' każijiet serji ta' fsada matul il-perijodu ta' studju ta' 28 ġurnata kien ta' 3.5% u ta' 2.0% fil-pazjenti li ħadu drotrecogin alfa (attivat) u dawk li ħadu l-plaċebo, rispettivament.
English: Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin
Maltese: Qabel jingħata, il-kunjetti ta' 20 mg ta' Xigris għandhom jiġu rikostitwiti b'10 ml Ilma Sterili għall-Injezzjoni, li jirriżulta f'soluzzjoni b'konċentrazzjoni ta' madwar 2 mg/ml drotrecogin alfa
English: As a component of routine care, measures of haemostasis (e.g., activated partial thromboplastin time (APTT), prothrombin time (PT) and platelet count) should be obtained during the infusion of Xigris.
Maltese: Bħala parti mill-assistenza ta' rutina, għandhom jittieħdu miżuri ta' l-emostażi (eż., il-ħin parzjali ta' thromboplastin attivat (APTT), il-ħin ta' prothrombin (PT) u l-għadd tal-plejtlets) waqt l-infużjoni ta' Xigris.
English: After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Maltese: Wara r-rikostituzzjoni b'10 ml ta' Ilma għall-Injezzjonijiet kull ml fih 2 mg ta' Drotrecogen alfa (attivat)
English: In placebo-controlled clinical trials in patients with severe sepsis, Xigris exerted an antithrombotic effect by limiting thrombin generation and improved sepsis-associated coagulopathy, as shown by a more rapid improvement in markers of coagulation and fibrinolysis.
Maltese: F'studji kliniċi kkontrollati bi plaċebo f'pazjenti b'sepsis gravi, Xigris kellu effett antitrombotiku billi llimita l-formazzjoni tat-trombina u tejjeb il-koagulopatija assoċjata mas-sepsis, kif jidher minn titjib aktar mgħaġġel fl-indikaturi tal-koagulazzjoni u fibrinoliżi.
English: The plasma clearance of drotrecogin alfa (activated) is approximately 41.8 l/hr in sepsis patients as compared with 28.1 l/hr in healthy subjects.
Maltese: It-tneħħija mill-plażma ta' drotrecogin alfa (attivat) hija ta' madwar 41.8 l/siegħa għal pazjenti bis-sepsis meta nqabbluha ma' 28.1 l/siegħa f'persuni b'saħħithom.
English: a) you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris b) you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine) c) you have been born with bleeding tendencies d) you have bled from your bowels within the last six weeks, unless treated adequately e) you have had a major accident and are at increased risk of bleeding
Maltese: a) jekk kellek kirurġija fi żmien tnax-il siegħa qabel ma tingħata Xigris, jew fsada minn kirurġija preċedenti, jew kirurġija fl-istess żmien li tkun qed tingħata Xigris b) jekk dħalt fl-isptar minħabba trawma serja tar-ras, jew kellek kirurġija tal-moħħ jew ta' l ispina, jew kellek fsada fil-moħħ (puplesija emorraġika) fl-aħħar tliet xhur, jew għandek vini jew arterji anormali fil-moħħ, jew massa fir-ras; għandek kateter epidurali (tubu fl-ispina) c) jekk għandek tendenzi ta' fsada mit-twelid d) jekk kellek fsada mill-imsaren fl-aħħar sitt ġimgħat, sakemm ma saritx il-kura neċessarja e) jekk kellek inċident serju u għandek riskju akbar ta' fsada
English: Xigris should not be used if you have a less severe form of sepsis (only one organ failure) and have recently had a surgical operation.
Maltese: Pazjenti b'disfunzjoni ta' organu wieħed u kirurġija recenti
English: Bleeding
Maltese: Fsada
English: A hospital pharmacist, nurse or doctor will have dissolved the Xigris powder in water for injection and sodium chloride solution.
Maltese: Spiżjar fl-isptar, infermier jew tabib ikun ħall it-trab Xigris fl-ilma għall-injezzjonijiet u soluzzjoni ta' sodium chloride.
English: Sodium chloride
Maltese: Aktar Esperjenza Klinika
English: Paediatrics: Data from a placebo-controlled clinical trial which was stopped for futility after 477 patients 0 to 17 years-old had received the study treatment did not establish efficacy of Xigris in paediatric patients and showed a higher rate of central nervous system bleeding in the Xigris versus placebo group.
Maltese: Skont l-informazzjoni li ħarġet minn studju kliniku kkontrollat bi plaċebo, li twaqqaf minħabba l-inutilità wara li 477 pazjent bejn it-twelid u s-17-il sena kienu ngħataw il-kura għal skopijiet ta' studju, instab li Xigris ma kienx effikaċi f'pazjenti żgħar, u wriet li dawk li ħadu
English: A vial contains 5 mg of drotrecogin alfa (activated).
Maltese: Kull kunjett ta' Xigris fih 5 mg drotrecogin alfa (attivat).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: The incidence of CNS bleeds during the 28-day study period was 0.2% and 0.1% for drotrecogin alfa (activated)treated and placebo-treated patients, respectively.
Maltese: L-inċidenza ta' każijiet ta' fsada fis-Sistema Nervuża Ċentrali matul it-terminu ta' studju ta' 28 ġurnata kienet ta' 0.2% u ta' 0.1% fil-pazjenti li ħadu drotrecogin alfa (attivat) u l-plaċebo, rispettivament.
English: Excipient: Each vial contains approximately 68 mg sodium.
Maltese: Kull kunjett fih madwar 68 mg ta' sodium.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħra ħlief ma' dawk imsemmija f'sezzjoni 6.6.
English: The pharmacokinetics of drotrecogin alfa (activated) have not been studied in patients with severe sepsis and pre-existing end stage renal disease and chronic hepatic disease.
Maltese: Il-farmakokinetika ta' drotrecogin alfa (attivat) ma ġietx studjata fil-pazjenti b'sepsis gravi li jkunu jbatu b'mard terminali tal-kliewi jew b'mard kroniku talfwied.
English: If the infusion is interrupted for any reason, Xigris should be restarted at the 24 μg/kg/hr infusion rate and continued to complete the full recommended 96 hours of dosing administration.
Maltese: Huwa rrakomandat li Xigris jiġi infuż b'pompa għall-infużjoni sabiex tiġi kkontrollata bi preċiżjoni r-rata ta' infużjoni.
English: Paediatric patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: A planned interim analysis (with 400 patients enrolled) showed a low likelihood of demonstrating a significant difference in the primary endpoint of “Composite Time to Complete Organ Failure Resolution” (CTCOFR score of 9.8 versus 9.7 mean days over 14 days).
Maltese: Analiżi parzjali li kienet ippjanata (fuq 400 pazjent irreġistrat) uriet li ftit kien hemm iċ-ċans li toħroġ xi differenza sinifikanti fil-konklużjoni ewlenija tar-“Riżoluzzjoni Ħin Kompożitu sa meta l-Organu Jieqaf Jaħdem Għal Kollox” (Skor CTCOFR ta' 9.8 kontra 9.7 medja ta' ġranet iktar minn 14-il ġurnata).
English: Powder for solution for infusion.
Maltese: Trab għal soluzzjoni għall-infużjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Xigris 20 mg powder for infusion
Maltese: Xigris 20mg trab għal infużjoni
English: A vial contains 20 mg of drotrecogin alfa (activated).
Maltese: Kull kunjett ta' Xigris fih 20 mg drotrecogin alfa (attivat).
English: When administering drotrecogin alfa (activated) at low flow rates (less than approximately 5 ml/hr), the infusion set must be primed for approximately 15 minutes at a flow rate of
Maltese: Drotrecogin alfa (attivat) għandu effett minimu fuq il-PT.
English: Co-administration of low-dose heparin for prophylaxis of venous thrombotic events (VTE) Low-dose heparin for VTE prophylaxis may be co-administered with drotrecogin alfa (activated).
Maltese: Minħabba dawn il-fatturi bijoloġiċi u analitiċi varji, l-APTT m'għandux jintuża biex jitkejjel l-effett farmakodinamiku ta' drotrecogin alfa (attivat).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18 April 2006 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jintrabat li jagħmel l-istudji u l-attivitajiet addizzjonali ta' farmakoviġilanza mniżżlin fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni tat-18 ta' April 2006 tal-Pjan dwar l-Immaniġġar tarRiskju (RMP) ippreżentat fit-Taqsima 1.8.2 ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u f'kull aġġornament ta' l-RMP li jista' jkun hemm u li jkun qabel miegħu is-CHMP.
English: Risks
Maltese: Riskji
English: Member State
Maltese: Stat Membru
English: Benefit/risk balance
Maltese: Bilanċ benefiċċju/riskju
English: Route of administration
Maltese: Mod ta' Amministrazzjo ni
English: Acute infectious bursal disease in poultry: Isolation and characterization of a highly virulent strain.
Maltese: Isolation and characterization of a highly virulent strain.
English: The MAH provided 2 pivotal studies, 7 supportive studies and 4 field studies.
Maltese: Il-MAH ipprovda 2 studji pivotali, 7 studji ta' appoġġ u 4 studji prattiċi.
English: THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: VETERINARJU, SPEĊI LI FUQHOM GĦANDU JINTUŻA LPRODOTT, MOD TA' AMMINISTRAZZJONI, DOŻA RAKKOMANDATA, PERJODU TA' TIŻMIN, APPLIKANT/DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: monograph 01/2008:0587 is not directly applicable, the vaccine strain was shown to be compliant with its section 2.4.1 “safety”.
Maltese: Għalkemm il-monografu Ph. Eur. 01/2008:0587 mhuwiex applikabbli direttament, ir-razza tal-vaċċin intweriet li hija konformi mas-sezzjoni 2.4.1 tiegħu “sigurtà”.
English: Pharmaceutical form
Maltese: TAL-PRODOTT MEDIĊINALI
English: Benefit/Risk assessment
Maltese: 2.3. Valutazzjoni Benefiċċju/Riskju
English: Applicant/ Marketing Authorisation Holder
Maltese: Applikant/ Detentur talAwtorizzazzjon i għat-Tqegħid fis-Suq
English: The vaccine is indicated for the active immunisation of chickens with maternal antibody levels of ≤ 500 ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
Maltese: Il-vaċċin huwa indikat għat-tilqim attiv tat-tiġieġ b'livelli ta' antikorpi maternali ta' ≤ 500 unità ELISA, sabiex inaqqas il-mortalità u l-leżjonijiet bursali tal-marda Gumboro.
English: (using SPF chickens).
Maltese: Eur. (permezz ta' tiġieġ SPF).
English: Benefits
Maltese: Benefiċċju
English: Having considered all the overall submitted data in writing the CVMP concluded that:
Maltese: Wara li kkunsidra d-dejta sottomessa b'mod ġenerali bil-miktub, is-CVMP ikkonkluda li:
English: Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.
Maltese: Minħabba l-patoġeniċità residwali tagħha, ir-razza tal-vaċċin, V877, hija kklassifikata bħala “plus intermedju” u magħrufa wkoll bħala razza “taħraq”.
English: The Marketing Authorisation Holder (MAH) provided 5 pivotal studies, 7 supportive studies and 3 field studies in order to assess safety of the vaccine.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ipprovda 5 studji pivotali, 7 studji ta' appoġġ u 3 studji prattiċi sabiex jivvaluta s-sigurtà tal-vaċċin.
English: An onset and duration of protection of respectively 14 and 32 days were demonstrated.
Maltese: Il-bidu u t-tul tal-protezzjoni ta' 14 u 32 jum rispettivament intwerew.
English: monograph (01/2008:0587) for classical IBDV vaccines, in that there was bursal damage and an interference on the serological response to NDV, it was acknowledged that there was no requirement to comply with this monograph because the product was classified as an intermediate plus strain.
Maltese: o Għalkemm il-prodott ma kkonformax ma' monografu Ph. Eur. (01/2008:0587) għal vaċċini tal-IBDV klassiċi, minħabba li kien hemm ħsara bursali u interferenza fuq ir-rispons seroloġiku għall-NDV, ġie rikonoxxut li ma kien hemm ebda rekwiżit li jkun hemm konformità ma' dan il-monografu minħabba li l-prodott kien ikklassifikat bħala razza intermedja plus.
English: This reduced serological response against NDV was however not translated into a reduction of the clinical protection against a virulent challenge.
Maltese: Madankollu, dan it-tnaqqis fir-rispons seroloġiku kontra NDV ma ġiex tradott fi tnaqqis tal-protezzjoni klinika kontra sfida virulenti.
English: Italy
Maltese: IdDanimarka
English: • Efficacy of the vaccine (minimum titre) has been shown using SPF chickens of the minimum age recommended: reduction of the bursal lesions and prevention of the mortality caused by a vvIBDV was achieved in those animals.
Maltese: • L-effikaċja tal-vaċċin (minimum titre) intweriet bl-użu ta' tiġieġ SPF tal-età minima rrakkomandata: it-tnaqqis tal-leżjonijiet bursali u l-prevenzjoni tal-mortalità kkawżata minn vvIBDV inkisbet f'dawk l-annimali.
English: An onset and duration of protection of respectively 14 and 32 days have been demonstrated.
Maltese: Bidu u tul fil-protezzjoni ta' 14 u 32 jum rispettivament intwerew.
English: The results showed that the vaccine strain notably reduced the serological response induced by vaccination against Newcastle Disease Virus (NDV) observed in chickens previously vaccinated using Poulvac Bursa Plus.
Maltese: Ir-riżultati wrew li rrazza tal-vaċċin naqqset ħafna r-rispons seroloġiku indott mit-tilqima kontra l-Virus tal-Marda Newcastle (Newcastle Disease Virus - NDV) osservat f'tiġieġ li qabel ġew imlaqqma b'Poulvac Bursa Plus.
English: Assessment of Poulvac Bursa Plus
Maltese: Valutazzjoni ta' Poulvac Bursa Plus
English: • Although no compatibility is claimed, serological data have been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Maltese: • Għalkemm ma ġiet ikklejmjata ebda kompatibilità, id-dejta seroloġika ġiet ipprovduta biex tappoġġja nuqqas ta' interazzjoni negattiva bejn Poulvac Bursa Plus u vaċċini oħrajn.
English: Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Maltese: Infettiva (IBDV), magħruf ukoll bħala l-marda Gumboro.
English: • The SPC reflects the results of the various safety studies.
Maltese: • L-SPC jirrifletti r-riżultati tal-istudji tas-sigurtà varji.
English: The onset and duration of immunity has also been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA levels as specified in the SPC.
Maltese: Il-bidu u t-tul tal-immunità ukoll ġew ikkonfermati fi flieles tal-brojlers kummerċjali fi studju tal-laboratorju simili fil-preżenza ta' livelli ta' MDA kif speċifikati fl-SPC.
English: In addition the intrinsic immunosuppressive nature of the vaccine strain is further evidenced in another study.
Maltese: Barra minn hekk, in-natura immunosuppressiva intrinsika tar-razza tal-vaċċin hija evidenzjata aktar fi studju ieħor.
English: • Product Safety Update Reports in the UK, where the product has been authorised since 1998, have not indicated a problem with immunosuppression.
Maltese: • Ir-Rapporti ta' Aġġornament tas-Sigurtà tal-Prodott fir-Renju Unti, fejn il-prodott ilu awtorizzat sa mill-1998, ma indikawx problema b'immunosuppressjoni.
English: The onset and duration of immunity has been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA.
Maltese: Il-bidu u t-tul tal-immunità ġew ikkonfermati fi flieles tal-brojler kummerċjali fi studju tal-laboratorju simili fil-preżenza tal-MDA.
English: • With respect to the level of bursal damage seen in SPF birds vaccinated with Poulvac Bursa Plus it is noted that the results of independent confirmatory testing of Poulvac Bursa Plus conducted by Germany and presented during the current procedure indicate that the level of bursal lesions seen are in line with those seen following vaccination with similar products which are already authorised in many Member States and therefore used widely within the European Union.
Maltese: • Fir-rigward tal-livell tal-ħsara bursali li tidher f'għasafar tal-SPF imlaqqma b'Poulvac Bursa Plus, huwa nnotat li r-riżultati ta' provi konfermatorji indipendenti ta' Poulvac Bursa Plus imwettqa mill-Ġermanja u ppreżentati matul il-proċedura attwali jindikaw li l-livell ta' leżjonijiet bursali li dehru huma konformi ma' dawk li jidhru wara vaċċinazzjoni bi prodotti simili li huma diġà awtorizzati f'bosta Stati Membri u għaldaqstant huma wżati b'mod mifrux fi ħdan l-Unjoni Ewropea.
English: monograph concerning the section 2.4.2 since higher than acceptable damage to the bursa of Fabricius was observed.
Maltese: Eur. dwar is-sezzjoni 2.4.2 minħabba li ġiet osservata ħsara iktar milli aċċettabbli għall-bursa ta' Fabricius.
English: Spain Fort Dodge Animal Health
Maltese: Spanja Fort Dodge Animal Health
English: • When administered to SPF chickens using a 10 times overdose, the vaccine does not cause clinical signs or mortality.
Maltese: • Meta mogħti lil tiġieġ SPF permezz ta' doża eċċessiva ta' 10 darbiet, il-vaċċin ma jikkawżax sinjali kliniċi jew mortalità.
English: • Efficacy of the vaccine in the presence of a range of MDA titres (mean titre of around 500 ELISA Units as recommended) was also shown under laboratory conditions: significant reduction of the bursal lesions was shown at 14 and 32 days post challenge.
Maltese: Unità ELISA kif irrakkomandat) intweriet ukoll taħt kundizzjonijiet tal-laboratorju: tnaqqis sinifikanti tal-leżjonijiet bursali ntwera f'14 u fi 32 jum wara l-isfida.
English: The risk of bursal damage and limited immunosuppression are clearly stated on the SPC (as is the need to restrict the use of the product to case of outbreaks of very virulent IBDV strains) and form part of the risk benefit assessment conducted by the veterinarian when deciding to use this product.
Maltese: Ir-riskju ta' ħsara bursali u ta' immunosuppressjoni limitata huma ddikjarati b'mod ċar fuq l-SPC (kif inhi wkoll il-ħtieġa li jkun limitat l-użu tal-prodott f'każ ta' tifqigħat ta' razez IBDV virulenti ħafna) u jifforma parti mill-valutazzjoni ta' riskju benefiċċju mwettaq millveterinarju meta jiddeċiedi dwar l-użu ta' dan il-prodott.
English: Layer chicks are clinically more sensitive than broilers
Maltese: Il-flieles tal-bajd huma klinikament aktar sensittivi mill-brojlers
English: The potential advantage of using “intermediate plus” or “hot” strains, such as the one contained in Poulvac Bursa Plus is that they could break through higher maternally derived antibodies (MDA) levels than milder strains can do.
Maltese: Il-vantaġġ potenzjali li jintużaw razez “plus intermedji” jew “sħan”, bħal dak li hemm fi Poulvac Bursa Plus huwa li dawn jistgħu jgħaddu minn livelli ogħla ta' antikorpi derivati maternalment (MDA) milli jistgħu jagħmlu razez iktar ħfief.
English: Slovenia Fort Dodge Animal Health
Maltese: Is-Slovenja Fort Dodge Animal Health
English: This is an acceptable risk associated with the protection provided against vvIBD in the face of MDA.
Maltese: Dan huwa riskju aċċettabbli assoċjat mal-protezzjoni pprovduta kontra vvIBD quddiem MDA.
English: The level of bursal lesions seen in independent confirmatory testing of Poulvac Bursa Plus is in line with those seen following vaccination with similar products which are already authorised in several Member States and used within the EU.
Maltese: Il-livell ta' leżjonijiet bursali li dehru fi provi konformitorji indipendenti ta' Poulvac Bursa Plus huwa konformi ma' dawk li dehru wara t-tilqim bi prodotti simili li huma diġà awtorizzati f'bosta Stati Membri u użati fi ħdan l-UE.
English: However, one of the problems to assess the efficacy of vaccination in commercial broilers (with MDA) under laboratory conditions is that they are usually not clinically affected by a vvIBDV challenge, as Specific Pathogen Free (SPF) chickens are.
Maltese: Madankollu, waħda mill-problemi biex tiġi vvalutata leffikaċja tat-tilqima fi brojlers kummerċjali (b'MDA) taħt kundizzjonijiet tal-laboratorju hija li normalment, dawn mhumiex klinikament affettwati minn sfida vvIBDV, kif inhuma tiġieġ Ħielsa minn Patoġen Speċifiku (SPF).
English: Ireland Fort Dodge Animal Health
Maltese: L-Irlanda Fort Dodge Animal Health
English: In view of the fact that no compatibility statement is claimed it is considered that sufficient information has been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Maltese: Minħabba lfatt li ma ġiet ikklejmjata ebda dikjarazzjoni tal-kompatibilità, huwa meqjus li ġiet ipprovduta biżżejjed informazzjoni sabiex tappoġġja nuqqas ta' interazzjoni negattiva bejn Poulvac Bursa Plus u vaċċini oħrajn.
English: • The vaccine does not comply with the Ph. Eur.
Maltese: • Il-vaċċin ma jikkonformax mal-monografu Ph.
English: For Poulvac Bursa Plus, the optimum day of vaccination recommended in the Summary of Product Characteristics (SPC) needs to be calculated using the Kouwenhoven's formula; the target maximum MDA levels at the time of vaccination is 500 ELISA Units using a commercially available kit, but whatever the vaccination day calculation reaches, it is contra-indicated to vaccinate chickens less than 10 days of age.
Maltese: Għal Poulvac Bursa Plus, il-jum ottimali tat-tilqima rrakkomandat fis-Sommarju tal-Karatteristiċi talProdott (SPC) jeħtieġ li jiġi kkalkolat permezz tal-formola ta' Kouwenhoven; il-livelli
English: A detailed analysis of the data provided concluded that Poulvac Bursa Plus is able to overcome Infectious Bursal Disease ELISA titres of ≥ 500.
Maltese: Analiżi dettaljata tad-dejta pprovduta kkonkludiet li Poulvac Bursa Plus huwa kapaċi jegħleb titres Elisa ta' ≥ 500 tal-Marda Bursali
English: Bulgaria Fort Dodge Animal Health
Maltese: Il-Bulgarija Fort Dodge Animal Health
English: Latvia Fort Dodge Animal Health
Maltese: Il-Latvja Fort Dodge Animal Health
English: Estonia Fort Dodge Animal Health
Maltese: L-Estonja Fort Dodge Animal Health
English: Efficacy studies have been carried out both under laboratory conditions, in SPF and commercial chickens with MDA, and under field conditions.
Maltese: L-istudji tal-effikaċja twettqu kemm taħt kundizzjonijiet tal-laboratorju, fl-SPF u f'tiġieġ kummerċjali b'MDA, u f'kundizzjonijiet prattiċi.
English: Field data confirm the benefits of vaccination under practical conditions on sites which have experienced ongoing problems with vvIBD where intermediate products have not been successful at controlling the vvIBD problem.
Maltese: Dejta prattika tikkonferma l-benefiċċji tal-vaċċinazzjoni taħt kundizzjonijiet prattiċi fuq siti li esperjenzaw problemi bla waqfien b'vvIBD fejn prodotti intermedji ma kinux ta' suċċess fil-kontroll tal-problema vvIBD.
English: Lithuania Fort Dodge Animal Health
Maltese: Il-Litwanja Fort Dodge Animal Health
English: Poland Fort Dodge Animal Health
Maltese: Il-Polonja Fort Dodge Animal Health