FrancophonIA/ELRC3.0 huggingface dataset:
English: In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Maltese: III, 465 pazjent b'limfoma follikulari li reġgħet tfaċċat/refrattarja ntgħażlu b'mod każwali fl-ewwel pass għal terapija ta' induzzjoni b'CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone;
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Blitzima (the last dose of methylprednisolone may be given on the same day as the first infusion of Blitzima).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1,000 mg kuljum huwa rakkomandat qabel l-ewwel infużjoni ta' Blitzima (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' Blitzima).
English: Blitzima 100 mg concentrate for solution for infusion
Maltese: Blitzima 100 mg konċentrat għal soluzzjoni għal infużjoni
English: 3infusion related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Maltese: 3reazzjonijiet relatati malinfużjoni (edima ġeneralizzata, bronkospażmu, tħarħir, edima fil-larinġi, edima anġjonewrotik a, ħakk ġeneralizzat, anafilassi, reazzjoni anafilattojda)
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Maltese: Disturbi filwidnejn u fissistema labirintika tinnitus, uġigħ fil-widnejn telf tassmigħ5
English: levels4
Maltese: ANNESS III
English: Table 15 Summary of efficacy by baseline autoantibody status Week 24
Maltese: Tabella 15 Sommarju tal-effikaċja skont l-istat tal-awtoantikorpi fil-linja bażi Ġimgħa 24
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Blitzima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Maltese: 100 mg prednisone/prednisolone fil-vina eżatt qabel infużjoni b'rituximab biex jitnaqqsu r- rata u sseverità ta' reazzjonijiet akuti għall-infużjoni u/jew is-sindrome tar-reħa taċ-ċitokina.
English: The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported.
Maltese: Il-profil ta' sigurtà globali kien konsistenti mal-profil ta' sigurtà stabbilit sew ta' rituximab f'RA u GPA/MPA u ma kinux irrappurtati reazzjonijiet avversi talmediċina ġodda.
English: Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Maltese: Il-pazjenti randomised għall-grupp ta' rituximab rċevew 1,000 mg IV inizjali fil-Jum 1 tal-Istudju u t-tieni 1,000 mg IV fil-Jum 15 talIstudju.
English: Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Maltese: Limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika
English: Acne
Maltese: Treddigħ
English: If you respond well to treatment, you may be given Blitzima as a maintenance treatment.
Maltese: Jekk tirrispondi sew għat-trattament, għandek mnejn tingħata Blitzima bħala trattament ta' manteniment.
English: • Relapsed/refractory follicular lymphoma
Maltese: L-analiżi finali kkonfermat li l-kura
English: Thrombocytopenia
Maltese: Avvenimenti newroloġiċi
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult
Maltese: Dan huwa ekwivalenti għal 2,6% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: Repeated treatment courses with Blitzima are possible.
Maltese: Korsijiet ripetuti ta' kura bi Blitzima huma possibbli.
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Maltese: Din issindrome tista' tiġi assoċjata ma' xi karatteristiċi tas-sindrome tal-lisi tat-tumur bħall-iperuriċemija, iperkalimja, ipokalċimja, iperfosfatimja, insuffiċjenza akuta tal-kliewi, lactate dehydrogenase (LDH) elevat u tista' tkun assoċjata ma' kollass respiratorju akut u mewt.
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Maltese: F'pazjenti bi granulomatosi b'polianġite jew polianġite mikroskopika, in-numru ta' ċelluli B fid-demm periferali naqas għal < 10 ċelluli/μL wara infużjonijiet ta' rituximab 375 mg/m kull ġimagħtejn u fil-biċca l-kbira tal-pazjenti baqa' f'dan il-livell sa 6 xhur.
English: The recommended dosage of Blitzima for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Maltese: Id-dożaġġ rakkomandat ta' Blitzima għal terapija għall-induzzjoni ta' remissjoni ta' granulomatosi b'polianġite u polianġite mikroskopika hija ta' 375 mg/m tal-erja tas-superfiċje tal-ġisem, mogħti bħala infużjoni fil-vini darba fil-ġimgħa għal 4 ġimgħat (total ta' erba' infużjonijiet).
English: Muscle spasms Arthralgia
Maltese: Blitzima fih is-sodju
English: • feeling dizzy
Maltese: Prodott dilwit
English: Clinical laboratory findings Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Maltese: Mis-67 pazjent evalwat għall-antikorp uman kontra l-ġrieden (HAMA), ma kien innutat l-ebda rispons.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
Maltese: Disturbi fissistema nervuża parestesija, ipoestesija, aġitazzjoni, nuqqas ta' rqad, vażodilatazzjoni, sturdament, ansjetà disġewsja newropatija periferali, paralisi tannerv tal-wiċċ5
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy parameter
Maltese: FC waħdu - perjodu medjan ta' osservazzjoni ta' 48.1 xahar Parametru tal-Effikaċja
English: Dyspnoea Epistaxis Nasal congestion
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT
English: Contents of the pack and other information What Blitzima contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Blitzima
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn 97 pazjent bi granulomatosi b'polianġite u polianġite mikroskopika li rċevew 375 mg/m rituximab darba fil-ġimgħa għal erba'
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Maltese: Studji dwar CLL mhux ikkurata minn qabel u li reġgħet tfaċċat/refrattarja stabbilew li f'sa 25% tal-pazjenti kkurati b'R-FC in-newtropenija kienet imtawwla (definita bħala għadd ta' newtrofili li baqa taħt 1x10
English: Currently, there are limited data on possible drug interactions with rituximab.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Attwalment, teżisti informazzjoni limitata dwar l-interazzjonijiet possibbli ta' mediċini oħra ma' rituximab.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.
Maltese: Waqt provi kliniċi, infezzjonijiet fil-parti t'isfel tal-apparat respiratorju (inkluż pulmonite) kienu rrappurtati b'inċidenza simili fil-gruppi b'rituximab meta mqabbel mal-gruppi ta' kontroll.
English: Treatment of relapse
Maltese: Trattament ta' manteniment
English: The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Maltese: L-aktar infezzjonijiet komuni fil-grupp ta' rituximab kienu jinkludu infezzjonijiet fl-apparat respiratorju ta' fuq, gastroenterite, infezzjonijiet fl-apparat talawrina u herpes zoster.
English: 6.11 years
Maltese: NR 6.11-il sena
English: Package leaflet: Information for the patient Blitzima 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Maltese: Informazzjoni għall-pazjent Blitzima 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Maltese: Kura inizjali, bulky disease, darba fil-ġimgħa għal 4 dożi F'ġabra ta' informazjoni komuni minn tliet provi, 39 pazjent b'NHL taċ-ċellula B follikulari jew ta' grad baxx, kimoreżistenti jew li reġgħet tfaċċat, jew b'bulky disease (leżjoni waħda ≥ 10 ċm fiddijametru) ingħataw 375 mg/m ta' rituximab bħala infużjoni fil-vini kull ġimgħa għal erba' dożi.
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1,000 mg ma' kura mill-ġdid fit-tieni kors. Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni kienet ta' 170 sa 175 μg/mL għad-doża ta' 2 x 500 mg u 317 sa 370 μg/mL għad-doża ta' 2 x 1,000 mg. Cmax wara t-tieni infużjoni, kienet ta' 207 μg/mL għad-doża ta' 2 x 500 mg u varjat minn 377 sa 386 μg/mL għad-doża ta' 2 x 1,000 mg.
English: Orion Pharma Puh/Tel: + 358 10 4261
Maltese: OPH Oktal Pharma d.o.o. Tel: +386 1 519 29 22
English: Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Maltese: Rituximab kien mogħti f'dożaġġ ta' 375 mg/m2 waqt l-ewwel ċiklu ġurnata qabel il-kimoterapija u f'dożaġġ ta' 500 mg/m fl-ewwel ġurnata ta' kull ċiklu ta' kura sussegwenti.
English: Blitzima
Maltese: Anzjani
English: In clinical trials more than 3,100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Maltese: Fi provi kliniċi aktar minn 3,100 pazjent irċevew mill-anqas kors wieħed ta' kura u kienu segwiti għal perjodi li varjaw minn 6 xhur għal aktar minn 5 snin; madwar 2,400 pazjent irċevew żewġ korsijiet jew aktar ta' kura, b'aktar minn 1,000 pazjent li rċevew 5 korsijiet jew aktar.
English: heart failure4
Maltese: +infart mijokardijaku4 u
English: Slovak Republic1
Maltese: Repubblika Slovakka1
English: Murgašova 5 949 01 Nitra Slovak
Maltese: Murgašova 5 949 01 Nitra Slovak Republic
English: Poland Pharmagal Bio, s.r.o.
Maltese: Il-Polonja Pharmagal Bio, s.r.o.
English: Requirements for combined veterinary vaccines http://www.emea.europa.eu/pdfs/vet/iwp/005297en.pdf CVMP Note for guidance: Field trials with veterinary vaccines - http://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf
Maltese: CVMP Nota għal gwida: Provi kliniċi b'vaċċini veterinarji - http://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf
English: Pasteurella multocida serotype A ≥ 2'1 log2 (*)
Maltese: Pasteurella multocida serotip A ≥ 2'1 log2 (*)
English: The data have been collected over a number of years (at least 2004-2008) and included a total of 163,061 pigs, of which 93,460 had been vaccinated with APPM Respipharm, 37,541 had been treated with an APP vaccine without P.multocida, and 32,060 pigs had not been vaccinated.
Maltese: L-informazzjoni nġabret fuq numru ta' snin (mill-inqas bejn l-2004 u l-2008) u kienet tinkludi total ta' 163,061 majjal, li 93,460 minnhom kienu tlaqqmu b'APPM Respipharm, 37,541 ġew trattati b'vaċċin tal-APP mingħajr P.multocida, u 32,060 majjal ma kinux ġew imlaqqma.
English: This opinion was supported by opinions gathered by the Applicant/MAH from EDQM and the Chairman of Group 15V.
Maltese: Din l-opinjoni kienet appoġġjata b'opinjonijiet li l-Applikant/MAH ġabar mill-EDQM u ċ-Chairman talGrupp 15V.
English: Pregnant sows: Vaccine dose: 3 ml
Maltese: Majjali nisa tqal: Doża tal-vaċċin: 3 ml
English: Slovak
Maltese: Slovak Republic
English: Suspension for injection
Maltese: Sospensjoni għal injezzjoni
English: Actinobacillus pleuropneumoniae serotype 9 ≥ 5,2 log2 (*)
Maltese: Actinobacillus pleuropneumoniae serotip 9 ≥ 5,2 log2 (*)
English: Actinobacillus pleuropneumoniae serotype 11 ≥ 4'9 log2 (*)
Maltese: Actinobacillus pleuropneumoniae serotip 11 ≥ 4'9 log2 (*)
English: These tests (Modified Agglutination Test for APP and optical density at 540nm for PMA) had been validated, however further questions were raised concerning the link between the initial antigen levels before inactivation (CFU/ml for all components), the post inactivation specifications (MAT for APP and OD540nm for PM) and the serological potency assay.
Maltese: Dawn it-testijiet (Test tal-Agglutinazzjoni Modifikata għall-APP u d-densità ottika f'540 nm għall-PMA) kienu ġew validati, madankollu tqajmu iżjed mistoqsijiet rigward ir-rabta bejn il-livelli inizjali tal-antiġeni qabel id-diżattivazzjoni (CFU/ml għall-komponenti kollha), l-ispeċifikazzjonijiet ta' wara d-diżattivazzjoni (MAT għall-APP u OD540nm għall-PM) u l-assaġġ tal-qawwa seroloġika.
English: APPM Respipharm is a multi-component formaldehyde inactivated whole-cell bacterial vaccine containing three strains of Actinobacillus pleuropneumoniae (Serotypes 2, 9 and 11) and one strain of Pasteurella multocida (Serotype A), and includes aluminium hydroxide gel as adjuvant.
Maltese: APPM Respipharm huwa vaċċin batteriku ta' ċellola sħiħa multi-komponenti diżattivat bilformaldehyde li fih tliet razez ta' Actinobacillus pleuropneumoniae (Serotipi 2, 9 u 11) u razza waħda ta' Pasteurella multocida (Serotip A), u jinkludi ġell tal-idrossidu tal-aluminju bħala sustanza miżjuda.
English: (0062) allows levels residual formaldehyde above 0.5 g/L provided the level has been shown to be safe.
Maltese: Eur. (0062) jippermetti livelli ta' formaldehyde residwu ogħla minn 0.5 g/L bil-kundizzjoni li llivell ikun intwera li huwa mingħajr periklu.
English: Efficacy issues:
Maltese: Ħnienes miftuma:
English: The applicant has provided supporting opinions from EDQM and the Chairman of Group 15V which supports this interpretation.
Maltese: L-applikant ipprovda opinjonijiet ta' sostenn mill-EDQM u miċ-Chairman talGrupp 15V li jappoġġjaw din l-interpretazzjoni.
English: ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSION
Maltese: ANNEX III KUNDIZZJONIJIET GĦAT-TNEĦĦIJA TAS-SOSPENSJONI GĦALLAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Since formaldehyde is listed in Annex II of the MRL Council Regulation (EEC) No 2377/90 it has been accepted that it is not necessary for the protection of public health to establish a maximum residue limit.
Maltese: II tar-Regolament tal-Kunsill (KEE) Nru 2377/90 dwar il-MRL, kien aċċettat li mhuwiex neċessarju għall-protezzjoni tas-saħħa pubblika li jiġi stabbilit limitu massimu ta' residwi.
English: The significance of toxigenic group is supported by the specific monograph (2008/1360) which states (Section 2.2.2 Immunogenicity) that “The challenge strain for the following test is chosen to ensure challenge with each Ap toxin produced by the serotypes to be stated on the label…”.
Maltese: L-importanza tal-grupp tossiġeniku hija appoġġjata mill-monografija speċifika (2008/1360) li ssostni (Sezzjoni 2.2.2 Immunoġeniċità) li “Ir-razza ta' sfida għat-test segwenti hija magħżula biex tassigura sfida b'kull tossina Ap prodotta mis-serotipi li se jkunu indikati fuq it-tikketta…”.
English: or P.multocida.
Maltese: Perjodu ta' tiżmim
English: For immunization of piglets the first dose (2ml) should be given at age 6-8 weeks, followed by a second dose (2ml) 14-21 days later.
Maltese: Għall-immunizzazzjoni tal-ħnienes, l-ewwel doża (2ml) għandha tingħata ta' 6-8 ġimgħat, segwita mit-tieni doża (2ml) 14-21 ġurnata wara.
English: In view of the fact that Serotypes 9 and 11 belong to the same toxigenic group (Group 1, producing Apx1 and Apx2) and Serotype 2 belongs to Toxigenic Group 2, producing Apx2 and Apx3, then this Ph. Eur.
Maltese: Minħabba li s-Serotipi 9 u 11 jappartjenu għall-istess grupp tossiġeniku (Grupp 1, li jipproduċi Apx1 u Apx2) u s-Serotip 2 jappartjeni għall-Grupp Tossiġeniku 2, li jipproduċi Apx 2 u Apx 3, dan ir-rekwiżit tal-Ph.
English: The product is indicated for use in pigs (sows and weaned piglets) from 6 weeks of age, intended to induce active immunization of sows and piglets against pleuropneumonia caused by Actinobacillus pleuropneumoniae and against secondary infection by Pasteurella multocida.
Maltese: Il-prodott huwa indikat għall-użu fi ħnieżer (majjali nisa u ħnienes miftuma) li għandhom minn 6 ġimgħat 'il fuq, maħsub biex jipproduċi l-immunizzazzjoni attiva tal-majjali nisa u l-ħnienes kontra plewropnewmonite kkawżata minn Actinobacillus pleuropneumoniae u kontra infezzjoni sekondarja minn Pasteurella multocida.
English: The National Competent Authority of the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder:
Maltese: L-Awtorità Kompetenti Nazzjonali tal-Istat Membru ta' Referenza, għandha tiżgura li lkundizzjonijiet li ġejjin jiġu ssodisfati mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Withdrawal period
Maltese: Doża rrakkomandata
English: Weaned piglets:
Maltese: Majjali nisa tqal:
English: The Applicant/MAH confirmed that the diagnosis was conducted by experienced veterinary practitioners based on previous clinical history and on post mortem findings in cases of mortality.
Maltese: L-Applikant/MAH ikkonferma li d-dijanjożi saret minn professjonisti veterinarji ta' esperjenza fuq il-bażi tal-istorja klinika preċedenti u fuq sejbiet post mortem f'każijiet ta' mortalità.
English: Strains of Actinobacillus pleuropneumoniae producing Apx I, ApxII and ApxIII toxins:
Maltese: It-tossini Apx li hemm preżenti filprodott (Apx I, Apx
English: In brief, concerns were raised that the composition of Actinobacillus pleuropneumoniae serotypes in the vaccine (2, 9 and 11) were not based on the epizoological situation in Spain, where the most prevalent serotypes are 2, 4 and 7.
Maltese: Fil-qosor, tqajjem tħassib li l-kompożizzjoni tas-serotipi tal-Actinobacillus pleuropneumoniae filvaċċin (2, 9 u 11) ma kinux ibbażati fuq is-sitwazzjoni epiżooloġika fi Spanja, fejn l-aktar serotipi prevalenti huma 2, 4 u 7.
English: Additional information supporting the close antigenic relationship between APP Serotype 9 and 11 have also been presented.
Maltese: Ġiet ippreżentata wkoll informazzjoni addizzjonali li tappoġġja r-relazzjoni antiġenika mill-qrib bejn is-Serotipi 9 u 11 tal-APP.
English: The Ph. Eur.
Maltese: Il-Ph.
English: In addition, Spain considered that an adequate justification had not been provided for including the different serotypes of A.pleuropneumoniae and P. multocida into the same vaccine.
Maltese: Barra minn hekk, Spanja ħasset li ma kinitx ġiet ipprovduta ġustifikazzjoni adegwata għall-inklużjoni tas-serotipi differenti ta' A.pleuropneumoniae u P. multocida fl-istess vaċċin.
English: At the age of 6-8 weeks.
Maltese: Fl-età ta' 6-8 ġimgħat Vaċċinazzjoni mill-ġdid: Wara 14-21 jum.
English: Based on an interpretation of the specific monograph that is supported by EDQM it was considered that the applicant has met these requirements through the use of the challenge strains used.
Maltese: Ibbażat fuq interpretazzjoni tal-monografija speċifika appoġġjata mill-EDQM, kien ikkunsidrat li l-applikant issodisfa dawn ir-rekwiżiti bl-użu tar-razez ta' sfida li ntużaw.
English: This differentiation is based on identification of characteristic lesions by experienced veterinary staff at slaughterhouses.
Maltese: Dan id-divrenzjar huwa bbażat fuq l-identifikazzjoni ta' leżjonijiet karatteristiċi minn persunal veterinarju ta' esperjenza filbiċċeriji.
English: For immunization of sows the first dose (3ml) should be given 4-5 weeks before the expected farrowing date, with the second injection (3ml) at least 2 weeks before the expected farrowing date.
Maltese: Għall-immunizzazzjoni tal-majjali nisa, l-ewwel doża (3 ml) għandha tingħata 4-5 ġimgħat qabel iddata mistennija għat-tifrigħ, bit-tieni injezzjoni (3ml) mill-inqas ġimagħtejn qabel id-data mistennija għat-tifrigħ.
English: CVMP Note for guidance:
Maltese: Kwistjonijiet ta' kwalità:
English: Administration is by two intramuscular injections separated by 2-3 weeks.
Maltese: L-għoti jsir permezz ta' żewġ injezzjonijiet għal ġol-muskoli separati minn xulxin bi 2-3 ġimgħat.
English: Specific challenge studies had not been conducted using APP serotype 11 as challenge, therefore Spain had requested confirmation of efficacy of the APP 11 component.
Maltese: Ma sarux studji ta' sfida speċifika bl-użu tal-APP serotip 11 bħala sfida, għalhekk Spanja kienet talbet konferma tal-effikaċja tal-komponent APP 11.
English: The Note for Guidance on requirements for combined veterinary vaccines2, states “Deletion of challenges is only acceptable in rare cases and must be fully justified.”, and in addition Annex I to Directive 2001/82/EC as amended (Part 4 Efficacy tests, Field trials), which states that “Where laboratory trials cannot be supportive of efficacy, the performance of field trials alone may be acceptable.”.
Maltese: In-Nota għal Gwida dwar ir-rekwiżiti għal vaċċini veterinarji kombinati2, jiddikjaraw li “It-tneħħija tal-isfidi hija aċċettabbli biss f'każijiet rari u trid tkun iġġustifikata għal kollox.”, u barra minn hekk l-Anness I għad-Direttiva 2001/82/KE kif emendata (Parti 4 Testijiet tal-effikaċja, Provi prattiċi), li jiddikjara li “Meta l-provi fil-laboratorju ma jkunux jistgħu jappoġġjaw l-effikaċja, jista' jkun aċċettabbli li jitwettqu provi prattiċi waħedhom.”.
English: Regarding justification of the P. multocida component in the vaccine the Applicant/MAH has provided field data from a surveillance study, supplemented with bibliographical data, to indicate that P.multocida causes frequent co-infections with APP in pigs with respiratory disease.
Maltese: Fir-rigward tal-ġustifikazzjoni tal-komponent ta' P.multocida fil-vaċċin, l-Applikant/MAH ipprovda dejta prattika minn studju ta' sorveljanza, issupplimentata b'informazzjoni biblijografika, biex juri li l-P.multocida tikkawża ko-infezzjonijiet frekwenti bl-APP f'majjali li jkollhom mard respiratorju.