qanastek/EMEA-V3 huggingface dataset:
Reproduction is authorised provided the source is acknowledged How has Nobilis Influenza H5N6 been studied?
Reproduction is authorised provided the source is acknowledged Kif ġie studjat Nobilis Influenza H5N6?
The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N6.
Il- kumpanija wetqet studji ta 'laboratorju fuq is- sigurtà bl- użu ta' vaċċin simili ħafna għal Nobilis Influenza H5N6.
They also tested the safety of three standard production batches of Nobilis Influenza H5N6.
Barra minn hekk, il- kumpanija vverifikat is- sigurtà ta 'tliet lottijiet ta' produzzjoni standard ta 'Nobilis Influenza H5N6.
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N6 are still ongoing and will be assessed.
Il- vaċċin huwa evalwat fil- kuntest ta ’ sitwazzjoni ta ’ emerġenza li jfisser għadu għaddej studju ulterjuri fuq in- Nobili sH5N6 u dan ser jiġi evalwat.
What benefit has Nobilis Influenza H5N6 shown during the studies?
Liema benefiċċju wriet l- Influwenza Nobilis H5N6 waqt l- istudji li ġew mwettqa?
When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Il- mezzi subkutaneji u intramuskolari meta mqabbla wrew li jipproduċu l- istess effetti. • Il- vaċċin wera li jnaqqas is- sinjali kliniċi u l- mortalità u jnaqqas it- tixrid tal- vajrus f’ tiġieġ infettati. • Il- vaċċin huwa kapaċi li jistimola antikorpi f’ varjetà vasta ta ’ għasafar. • Jekk il- vajrus ta ’ l- influwenza avjarju li jiċċirkola għandu komponent N differenti mill- N6li jinsab fil- vaċċin, jista ’ jkun possibbli li wieħed jagħmel differenza bejn vaċċin minn għasfur infettat u dak vaċċinat permezz ta ’ test dijanjostiku sabiex jiġu misjuba antikorpi Neuraminidase.
What is the risk associated with Nobilis Influenza H5N6?
X’ inhu r- riskju assoċjat ma ’ l- Influwenza Nobilis H5N6?
Page 2/ 3 ©EMEA 2008 Why has Nobilis Influenza H5N6 been approved?
Għaliex ġiet appruvata l- Influwenza Nobilis H5N6?
Nobilis Influenza H5N6 has been authorised under “ Exceptional Circumstances”.
Paġna 2/ 3 ©EMEA 2008 Influwenza Nobilis H5N6 ġie awtorizzat taħt “ Ċirkustanzi Eċċezzjonali ”.
Other information about Nobilis Influenza H5N6:
Informazzjoni oħra dwar l- Influwenza Nobilis H5N6:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N6 to Intervet International BV on 31.01.2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għall- Influweza Nobilis H5N6 lil Intervet International BV fil- 31. 01. 2008.
This summary was last updated on 31.01.2008.
Dan is- sommarju ġie aġġornat l- aħħar fil - 01. 2008.
Invented Name
Kontenut
Pharmaceutical Form
Speċi li
Target species
Ippakkjar
Route of administration
Daqs tal - Żmien ta ’
Packaging
ivvintat
Content
fuqhom
Package size
pakkett Tiżmim
Withdrawal period
jintuża l - prodott
HI titre ≥ 6.0 log2
Titru HI ≥
Emulsion for injection
Emulsjoni għal
Intramuscular or subcutaneous
Titqiba fil -
Glass bottles (hydrolytical class II) with rubber stopper and aluminium cap
Fliexken ta ’ ħġieġ
Zero days
wieħed
HI titre ≥ 6.0 log2
Titru HI ≥ 6. 0 log2 kull doża
Intramuscular or subcutaneous
Titqiba fil - muskolu jew taħt il- ġilda
Glass bottles (hydrolytical class II) with rubber stopper and aluminium cap
Fliexken ta ’ ħġieġ (idrolitiku tip II) b’ tapp tal- gomma u kappa tal- aluminjum.
Zero days
Flixkun Xejn ġranet wieħed
PET bottles with rubber stopper and aluminium cap
Fliexken tal- PET b’ tapp tal- gomma u kappa tal- aluminjum
Nobilis Influenza H5N6 emulsion for injection for chickens
Nobilis Influenza H5N6 emulsjoni għal injezzjoni għal flieles
Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/ duck/ Potsdam/ 2243/ 84), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Antiġen sħiħ inattivat tal- virus tal- influwenza avjarja, tas- subtip H5 (strejn H5N6 A/ duck/ Potsdam/ 2243/ 84), li jinduċi titru ta ’ HI ta ’ ≥6. 0log2, kif ittestjat skond it- test ta ’ potenza.
For active immunisation of chickens against avian influenza type A, subtype H5.
Għal immunizzazzjoni attiva fil- flieles, kontra l- Influwenza avjarja tip A, subtip H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Tnaqqis ta ’ sinjali kliniċi, imwiet u tneħħija tal- virus wara tlaqqiegħ ma strejn virulenti ta ’ H5N1 ġew murija fi żmien ġimgħatejn wara doża waħda ta ’ tilqim.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Anti- korpi fis- sirum ġew murija li jippersistu fil- flieles sa mill- anqas 7 xhur u studji magħmula bi strejns oħra ta ’ tilqim urew li l- antikorpi fis- sirum jkun mistenni li jippersistu fil- flieles għal tal- anqas 12- il xahar wara amministrazzjoni ta ’ żewġ dożi tal- vaċċin.
This vaccine has been tested for safety in chickens and some supportive data for safety in ducks are available.
Il- livell ta ’ effikaċja milħuq jista ’ jvarja u jiddependi minn kemm jixxiebhu l- istrejn tal- vaċċin u l - istrejns jiċċirkulaw fil- beraħ.
If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination.
Din it- tilqima ġiet ittestjata għas- sigurta tagħha fil- flieles.
The level of efficacy for other species may differ from that observed in chickens.
Jekk tintuża fi speċi avjarji oħra, kkunsidrati fil- periklu ta ’ infezzjoni, l- użu tagħha f’ dawn l- ispeċi għandu jsir bil- għaqal, u huwa ta ’ parir li wieħed jipprova t- tilqima fuq numru żgħir ta ’ għasafar qabel ma wieħed ilaqqam ammonti kbar.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Il- livell ta ’ effikaċja fi speċi oħra jista ’ jkun differenti minn dak osservat fil- flieles.
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Din tippersisti għal madwar 14- il ġurnata.
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fi żmien 14- il ġurnata qabel jew wara li tlaqqam b' dan il- prodott.
It is recommended to use a closed multidose vaccination system.
Huwa rakkomandat li tintuża s- sistema ta ’ tilqim magħluqa multiġekt.
Chickens From 8-14 days old:
Minn 8 sa 14 – il ġurnata:
0.25 ml subcutaneously From 14 days to 6 weeks old:
Minn 14- il ġurnata sa sitt ġimgħat:
0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older:
0. 5ml taħt il- ġilda jew fil- muskolu.
Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Tilqim ta ’ frieh minn tjur imlaqqma, għandu għaldaqstant jiġi ttardjat sakemm dawn il- antikorpi jkunu tbaxxew.
If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies.
Jekk il- virus tal- influwenza avjarja li qed jiċċirkula fil- beraħ għandu l- komponent N tiegħu differenti mill- N6, inkluż fil- vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijanjostiku li jagħraf antikorpi nuraminidejs.
2 years Glass vials:
6. 2 Inkompatibilitajiet
1 year
Fjali tal- PET: sentejn Fjali tal- ħġieġ: sena
Store refrigerated (2°C to 8°C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Olanda
Any person intending to import, sell, supply and/ or use Nobilis Influenza H5N6 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
L- importazzjoni, bejgħ, provista u / jew l- użu ta 'Nobilis Influenza H5N6 huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
The use of this veterinary medicinal product is only allowed under the particular conditions established by the European Community legislation on the control of Avian Influenza.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Nobilis Influenza H5N6 għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi kurrenti ta 'tilqim qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. < MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT >
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manufatturi tas- sustanza( i) bioloġika( ċi) attiva( i)
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL – 5831 AN Boxmeer Olanda
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spain
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spanja.
To be supplied only on veterinary prescription.
Sabiex tiġi mogħtija biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- Awtorizzazzjoni tal- Kummerċ għandu jinforma lill- Kumissjoni Ewropeja dwar pjanijiet ta ’ kummerċjalizzazzjoni ta’ dan il- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
7 Ċ KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
Dawn is- sustanzi li jinstabu fil- prodott finali huma nklużi fl- Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90:
Pharmacologically active substance Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine
Sustanza farmakoloġikament
Other provisions
Speċi ta ’
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Dispożizzjonijiet oħrajn
II.
attiva
II. A.1 Composition
l- annimal/ i
Only H5N6 antigen produced in eggs must be used to formulate the vaccine.
Paraffina likwida ħafifa Polisorbejt 80 Sorbitan mono- olejt (E 494) Glajsin
The maximum quantity of virus that may be blended (which should be linked to what has been shown safe) should be specified.
L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu
II. B.3 Validation studies
OBBLIGAZZJONIJIET SPEĊIFIĊI TA 'SID L- AWTORIZZAZZJONI TAL - KUMMERĊ
The inactivation kinetics study has been conducted with a batch of H5N6 antigen that had a pre- inactivation titre of 9.8 log10 EID50 / ml and this should be the maximum pre-inactivation titre for batches of antigen.
Sid l- Awtorizzazzjoni tal- Kummerċ għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
STARTING MATERIALS
ASPETTI KWALITATTIVI II. A. 1 Kompożizzjoni:
Embryonated chicken eggs (for vaccine production):
Il- vaċċin għandu jkun formulat sabiex ikollu biss l- antiġenu H5N6 prodott fil- bajd.
The Applicant should confirm that the country of origin of the source flock(s) is Spain and that there will be no change to the source (or changes to the disease control measures applied to the flocks) without informing the CVMP.
II. B.
2.
Mod ta ’ preparazzjoni 2.
H5N6 Working Seed Viruses:
Tpoġġija tal- antiġenu fit- taħlit:
There is no mention of any WSV testing for subtype H5N6 and the Applicant should accept a specific obligation to provide information on the tests conducted on each batch of Working Seed Virus.
Huwa nnutat mill- iskeda ta ’ eżempji ta ’ taħlit, li lottijiet tal- vaċċin huma mħallta sabiex ikun fihom tal- anqas 13. 4 log10 EID50 kull 1000 kg.
Tryptose:
II. B. 3 Studji ta ’ Validita 3.
The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
L- istudji kinetiċi ta ’ inattivazzjoni kienu kondotti b’ lott ta ’ antiġenu H5N6 li kellu tajter ta ’ pre - inattivazzjoni ta ’ 9. 8 log10 EID50/ ml, u dan għandu jkun l- ogħla tajter ta ’ pre- inattivazzjoni għall - lottijiet tal- antiġenu.
Specific Measures concerning the prevention of the transmission of animal spongiform encephalopathies
Materjal tal- bidu II. C. 1 Mniżżla fil- lista tal- Farmakopeja
Tryptose and NZ-Amines:
Bajd SPF:
The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable.
Għandhom jingħataw dettalji tal- qtajja tat- tjur li jintużaw bħala sors tal- bajd għall - preparazzjoni tal- working seed viruses.
Up-to- date information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/ Kerry.
II. C. 2 Mhux fil- lista tal- Farmakopeja
A TSE Declaration of Compliance and revised supporting TSE compliance tables should be provided to address - a) the issues raised in Point 8, above, and b) the out of date information and certification which have been provided for the sources of gelatine.
L- applikant għandu jikkonferma li l- pajjiż ta ’ oriġini minn fejn jiġu l- qtajja ta ’ tjur li jintużaw bħala sors huwa Spanja u li mhux se jkun hemm tibdil fis- sors (jew tibdil fil- miżuri għal kontroll tal- mard fil- qtajja), mingħajr ma jinfurmaw lil KPMV.
Results should be provided from in-process tests on three batches of H5N6 antigen, to demonstrate batch consistency.
M’ hemm xejn imsemmi dwar ittestjar ta ’ WSV għas- subtip H5N6 u l- applikant għandu jaċċetta obligazzjoni speċifika li jipprovdi nformazzjoni fuq it- testijiet li jsiru fuq kull lott ta ’ Working Seed Virus.
It is assumed that in-process tests are conducted at each of the proposed sites of antigen manufacture.
L- użu ta ’ postijiet ta ’ oriġini mhux speċifikati għall- baqar li jipprovdu l - ħalib u sorsi mhux identifikati ta ’ tryptose u amini NZ, mhux ikkunsidrat aċċettabbli.
No information has been provided on the steps taken to ensure the equivalence of results obtained from tests conducted at the three sites of antigen manufacture e. g. for the virus titration and associated HA tests.
L - applikant irid jaqbel li s- sors ta ’ Tryptose u Amini- NZ (speċifikati) ikun minn kumpaniji mingħand min ġew provduti dikjarazzjonijiet fuq il- ħalib, u mniżżla fid- dossjer sottomess, flimkien ma ’ dettalji fuq il- postijiet ta ’ oriġini minn fejn jiġu l- annimali li jipprovdu l- ħalib.
Reassurances should be provided on the equivalence of tests and test results from the different sites.
Dikjarazzjoni ta ’ qbil mal- miżuri ta ’ TSE u skedi riveduti ta ’ qbil u li jappoġġjaw is- sistemi ta ’ TSE għandhom ikunu provduti u jindirizzaw - a) Il - punti msemmija f ’ punt 8, fuq u b) Informazzjoni barra minn żmienha u ċertifikazzjoni provduta għas- sorsi ta’ ġelatina..
CONTROL TESTS ON THE FINISHED PRODUCT
Testijiet ta ’ kontroll waqt il- produzzjoni
II. E.2 Identification and assay of active ingredients
Testijiet ta ’ kontroll fuq il- prodott lest.
Batch potency test:
Test tas- saħħa tal- lott:
The Applicant should provide the SOP and further details on the conduct of the batch potency test for Nobilis Influenza H5N6.
L- applikant għandu jipprovdi Proċess Operattiv Standard u aktar dettalji dwar kif isir test tas- saħħa tal- lott għal Nobilis Influenza H5N6.
It should be clarified what route of vaccination is used, how the sera are tested (in a pool or individually), whether all chickens have to develop a titre of 6.0 log2 or if this is a mean titre.
Għandu jkun iċċarat x’ rotta ntużat għall- vaċċinazzjoni, kif is- sirum jiġu ttestjati (f’ salt jew individwalment), jekk il- flieles kollha għandhom’ x jiżviluppaw tajter ta ’ 6. 0log2, jew jekk dan hux tajter medju.
It should be indicated what reference antigen is used in the HI test and details should be provided on the standards included in the test.
Għandu jiġi muri x’ antiġen ta ’ referenza ntuża fit- test tal- HI, għandhom jingħataw dettalji dwar l- istandards inklużi fit- test.
A proposal should be provided.
Proposta f’ dan is- sens għandha tkun provduta.
9 II. E.9 Batch to batch consistency
9 II. E. 9 Konsistenza bejn lott u ieħor.
Results should be provided for final product tests on three batches of Nobilis Influenza H5N6, to demonstrate batch consistency.
Għandhom jiġu provduti r- riżultati ta ’ testijiet fuq il- prodott finali ta ’ tlett lottijiet ta ’ Nobilis Influenza H5N6, sabiex tiġi murija konsistenza bejn il- lottijiet.
No information has been provided on the steps taken to ensure the equivalence of results obtained from tests on the final product, conducted at Boxmeer and Salamanca, (e. g. for the batch potency tests and HI and HA tests) and reassurances should be provided on the equivalence of tests and test results from the two sites.
Testijiet tas- saħħa tal- lott u testijiet HI u HA), u għandhom jingħataw assigurazzjonijiet fuq l- ekwivalenza tat- testijiet u r- riżultati minn dawn iż- żewġ postijiet.
II. F.
II. F Stabbilita II. F. 1 Stabbilita tal- antiġen fi kwantita:
STABILITY
16.
II. F.1
II. F. 1 Stabbilita tal- prodott finali
The antigen should be stored for no longer than 12 months at 2-8ºC pending the provision of data supporting a longer period of storage.
Għalkemm perjodu ta ’ ħażna ta ’ sentejn huwa aċċettabbli għal vaċcin mimli fi fliexken tal- PET taż- żewġ daqsijiet, iż- żmien ta ’ kemm il- prodott idum tajjeb, m’ għandux ikun itwal minn tnax – il xahar f’ temperatura ta ’ 2oC – 8oC, għal vaċċin mimli f’ kontenituri tal- ħġieġ, dejjem sakemm ma tingħatax informazzjoni li tappoġġja perjodu itwal ta ’ ħażna f’ kontenituri tal- ħġieġ.
II. F.1 Stability of the final product
ASPETTI TA ’ FARMAKOVIĠILANZA
13.
18.
Although a shelf life of 2 years can be accepted for vaccine filled into PET containers of both sizes, the shelf life should be no longer than 12 months at 2-8ºC for vaccine filled into glass containers, pending the provision of further information in support of a longer period of storage in the glass containers.
L- Applikant għandu jissottometti kull tlett xhur għall- ewwel sentejn, Rapport Aġġornat tal - Ħarsien tas- Saħħa, wara l- użu tal- prodott fil- beraħ.
The Applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Huwa wkoll rikjest protokoll li jassigura rekordjar u rappurtaġġ ta ’ tagħrif miġbur fil- beraħ, f’ relazzjoni ma ’ effetti mhux mixtieqa suspettati, inkluż nuqqas t’ effikaċja.
EFFICACY ASPECTS
ASPETTI T’ EFFIKAĊJA
Serology results for the efficacy study carried out in chickens by Katsma et al. should be provided.
Għandu jkun provdut.
Nobilis Influenza H5N6 Emulsion for injection
Nobilis Influenza H5N6 Emulsjoni għal injezzjoni
Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/ duck/ Potsdam/ 2243/ 84), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Antiġen sħiħ inattivat tal- virus tal- influwenza avjarja tas- subtip H5 (strejn H5N6, A/ duck/ Potsdam/ 2243/ 84), li jinduċi titru ta ’ HI ta ’ ≥6. 0log2, kif ittestjat skond it- test ta ’ potenza.
Active immunisation against avian influenza type A, subtype H5.
Għal immunizzazzjoni attiva kontra l- Influwenza avjarja tip A, subtip H5.
Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age.
Titqiba fil- muskolu jew taħt il- ġilda ta ’ 0. 25ml jew 0. 5ml skond l- eta ’.
Withdrawal period - Zero days
Xejn ġranet
Store refrigerated (2°C to +8°C).
Aħżen u ttrasporta ġo friġġ (2oC – 8oC).
For disposal read the package leaflet.
Dwar rimi, aqra l- fuljett informattiv ġewwa l- pakkett.
14 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/ duck/ Potsdam/ 2243/ 84), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Antiġen sħiħ inattivat tal- virus tal- influwenza avjarja, tas- subtip H5 (strejn H5N6, A/ duck/ Potsdam/ 2243/ 84), li jinduċi titru ta ’ HI ta ’ ≥6. 0log2, kif ittestjat skond it- test ta ’ potenza.
Intramuscular or subcutaneous injection Read the package leaflet before use.
Titqiba fil- muskolu jew taħt il- ġilda Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
16 PACKAGE LEAFLET FOR:
16 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL
Nobilis Influenza H5N6 emulsion for injection
Nobilis Influenza H5N6 emulsjoni għal injezzjoni
Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Olanda
Liquid paraffin
Paraffina likwida
Studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Anti- korpi fis- sirum ġew murija li jippersistu fil- flieles sa mill- anqas 7 xhur u studji magħmula bi strejns oħra ta ’ tilqim urew li l- antikorpi fis- sirum jkun mistenni li jippersistu fil- flieles għal tal- anqas 12- il xahar wara amministrazzjoni ta ’ żewġ dożi tal- vaċċin.
TARGET SPECIES
Flieles
Chickens.
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Għal użu taħt il- ġilda jew fil- muskolu.
For subcutaneous or intramuscular use.
0. 25ml taħt il- ġilda.
Chickens From 8-14 days old:
Minn 14- il ġurnata sa sitt ġimgħat:
0.25 ml subcutaneously From 14 days to 6 weeks old:
0. 25 jew 0. 5ml taħt il- ġilda jew fil- muskolu.
0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older:
0. 5ml taħt il- ġilda jew fil- muskolu.
0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
M’ hemmx informazzjoni dwar tilqim fil- preżenza ta ’ antikorpi li għaddew mill- omm.
Store at +2°C to +8°C.
Aħżen u ttrasporta fil- friġġ (+2°C sa +8°C).
After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Wara li tiftaħ, uża fi żmien 8 siegħat, sakemm il- prodott mhux suġġett għal temperaturi estremi, jew ġie kkontaminat.
18 No information is available on the safety of this vaccine for birds in lay.
M’ hemmx informazzjoni dwar is- sigurtà ta ’ din it- tilqima fi tjur tal- bajd.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi njettat bi żball b' dan il - prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'informazzjoni li tinsab fil- pakkett miegħek.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ idum għal aktar minn tnax - ilsiegħa, wara l - eżami mediku, erġa 'kellem lit- tabib.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jgħinu sabiex ikun protett l- ambjent.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu. /
If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies.
Jekk il- virus tal- influwenza avjarja li qed jiċċirkula fil- beraħ għandu l- komponent N tiegħu differenti mill- N6 inkluż fil- vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf antikorpi nuraminidejs.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
19 L- użu ta ’ dan il- prodott mediċinali veterinarju jitħalla jsir biss taħt kundizzjonijiet partikulari stabbiliti mill- leġislazzjoni tal- Komunita Ewropeja dwar il- kontroll tal- Influwenza Avjarja.
NOBILIS INFLUENZA H7N1
INFLUWENZA NOBILIS H7N1
What is Nobilis Influenza H7N1?
X’ inhi l- Influwenza Nobilis H7N1?
Nobilis Influenza H7N1 is a vaccine containing an inactivated avian influenza virus H7N1 (inactivated means that the virus has been killed so that it can no longer cause the disease).
Nobilis Influenza H7N1 is a vaccine containing an inactivated avian influenza virus H7N1 (inactivated means that the virus has been killed so that it can no longer cause the disease). L- Influwenza Nobilis H7N1 huwa vaċċin li fih il- vajrus avjarju inattivat ta ’ l- influwenza H7N1 (inattivat jiġifieri li l- vajrus ġie maqtul sabiex ma jkunx jista ’ jikkawwża l- marda).
What is Nobilis Influenza H7N1 used for?
X’ inhi l- użu ta ’ l- Influwenza Nobilis H7N1?
Nobilis Influenza H7N1 is a vaccine used in chickens and ducks to protect against avian influenza.
L- Influwenza Nobilis H7N1 huwa vaċċin użat fit- tiġieġ u l- papri sabiex jiġu protetti kontra l - influwenza avjarja.
The vaccine reduces the signs of flu in chickens and the excretion (shedding) and transmission (spreading) of the virus by the infected chickens and ducks.
Il- vaċċin inaqqas is- sinjali ta ’ influwenza fit- tiġieġ u l- ħmieġ (ħrif) u trasmissjoni (tixrid) tal- vajrus minn tiġieġ u papri infettati.
The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).
Il- vaċċin huwa injettat b’ mod intramuskolari (f’ muskolu) jew b’ mod subkutaneju (taħt il- ġilda).
How does Nobilis Influenza H7N1 work?
Kif taħdem l- Influwenza Nobilis H7N1?
Nobilis Influenza H7N1 is a vaccine.
L- Influwenza Nobilis H7N1 huwa vaċċin.
When it is given to chickens and ducks, the birds’ immune system (their natural defence mechanism) makes antibodies (a special type of protein) to fight the disease.
Meta tingħata lit- tiġieġ u lil papri, is- sistema immunitorja ta ’ l- għasafar (il- mekkaniżmu tad- difiża naturali tagħhom) toħloq antikorp (tip speċjali ta ’ proteina) sabiex tiġġieled il- mard.
In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.
Fil- futur, jekk l- għasafar huma esposti għall- vajrus ta ’ l- influwenza avjarja, is- sistema immunitorja tkun kapaċi toħloq antikorpi b’ mod aktar mgħaġġel u dan jgħin sabiex tiġi miġġielda l- marda.
The virus used for the vaccine carries the H7 (haemagglutinin 7) and N1 (neuramidase 1) antigens.
Il- vajrus użat fil- vaċċin iġorr l- antiġeni H7 (haemagglutinin 7) u n- N1 (neuramidase 1).
This strain has been chosen because it protects birds against virulent H7 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Din ir- razza ġiet magħżula minħabba li tipproteġi l- għasafar kontra d- damma tar- razza H7 virulenti (protezzjoni inkroċjata), filwaqt li twassal minn għasafar infettati għal dawk vaċċinati.
Vaccinated birds can be differentiated identified from infected birds by a diagnostic test for antibodies against the N1 component.
Għasafar vaċċinati jistgħu jiġu differenzjati b’ identifikazzjoni minn għasafar infettati permezz ta ’ test dijanjostiku għal antikorpi kontra l- komponent N1.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobilis Influenza H7N1 been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġiet studjata l- Influwenza Nobilis H7N1?
The company carried out laboratory studies using Nobilis Influenza H7N1 in chickens and ducks.
Il- kumpanija għamlet studji fil- laboratorju fuq tiġieġ u papri permezz ta ’ l- użu ta ’ l- Infuwenza Nobilis H7N1.
The company also performed a laboratory study in chickens with a vaccine similar to Nobilis Influenza H7N1.
Il- kumpanija għamlet studju fil- laboratorju wkoll fuq tiġieġ permezz ta ’ vaċċin simili għall - Influwenza Nobilis H7N1.
This vaccine has some of the same ingredients but a different antigen (virus) to Nobilis Influenza H7N1.
Dan il- vaċċin fih l- istess ingredjenti b’ antiġenu differenti (vajrus) mill - Influwenza Nobilis H7N1
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H7N1 are still ongoing and will be assessed.
Il- vaċċin huwa evalwat fil- kuntest ta ’ sitwazzjoni ta ’ emerġenza li jfisser għadu għaddej studju ulterjuri fuq in- Nobili sH7N1 u dan ser jiġi evalwat.
What benefit has Nobilis Influenza H7N1 shown during the studies?
Liema benefiċċju wriet l- Influwenza Nobilis H7N1 waqt l- istudji li ġew mwettqa?
• The results of the safety studies indicated that the product is safe for chickens and ducks.
• Ir- riżultati ta ’ l- istudji dwar is- sigurtà wrew li l- prodott huwa sigur għat- tiġieġ u l- papri.
When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to reduce clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine has been shown reduce virus shedding in infected ducks. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N1 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Il- mezzi subkutaneji u intramuskolari meta mqabbla wrew li jipproduċu l- istess effetti. • Il- vaċċin wera li jnaqqas is- sinjali kliniċi u l- mortalità u jnaqqas it- tixrid tal- vajrus f’ tiġieġ infettati. • Il- vaċċin wera t- tnaqqis fit- tixrid tal- vajrus f’ papri infettati. • Il- vaċċin huwa kapaċi li jistimola antikorpi f’ varjetà vasta ta ’ għasafar. • Jekk il- vajrus ta ’ l- influwenza avjarju li jiċċirkola għandu komponent N differenti mill- N1li jinsab fil- vaċċin, jista ’ jkun possibbli li wieħed jagħmel differenza bejn vaċċin minn għasfur infettat u dak vaċċinat permezz ta ’ test dijanjostiku sabiex jiġu misjuba antikorpi Neuraminidase.
What is the risk associated with Nobilis Influenza H7N1?
X’ inhu r- riskju assoċjat ma ’ l- Influwenza Nobilis H7N1?
The person who injects the vaccine should be careful to avoid accidental self injection.
Il- persuna li tinjetta l- vaċċin għandha toqgħod attenta sabiex tevita li tiġi injettata hija stess.
Why has Nobilis Influenza H7N1 been approved?
Għaliex ġiet appruvata l- Influwenza Nobilis H7N1?
The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in reducing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Il- Kumitat għall Użu ta ’ Prodotti Mediċinali għal użu Veterinarju kkonkluda li l- vaċċin wera li huwa effettiv fit- tnaqqis ta ’ mard kliniku fit- tjur u jista ’ jkun għodda utli fil- kontroll tal- firxa ta ’ infezzjoni ta ’ l- influwenza avjarja.
Due to the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation.
Minħabba s- sitwazzjoni epidemjoloġika attwali l- influwenza avjarja u ta ’ theddida sussegwenti kemm għas- saħħa tal- bniedem u ta ’ l- annimal, il- Kumitat jirrakkomanda l- għoti ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Nobilis Influenza H7N1 has been authorised under “ Exceptional Circumstances”.
Paġna 2/ 3 ©EMEA 2007 Influwenza Nobilis H7N1 ġie awtorizzat taħt “ Ċirkustanzi Eċċezzjonali ”.
Page 2/ 3 ©EMEA 2007 Other information about Nobilis Influenza H7N1:
Informazzjoni oħra dwar l- Influwenza Nobilis H7N1:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H7N1 to Intervet International BV on 14/ 05/ 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għall- Influweza Nobilis H7N1 lil Intervet International BV fil- 14/ 05/ 2007.
This summary was last updated in May 2007.
Dan is- sommarju ġie aġġornat l- aħħar fil - 05/ 2007.
Package Withdrawal size Period
Daqs tal - Perjodu pakkett ta ’ Tiżmim
HI titre ≥ Emulsion for 6.0 log2 per injection dose
HI ta ’ ≥6. 0log2
Chickens and ducks
Flieles u papri
Intramuscular Glass bottles or (hydrolytical class subcutaneous II) with rubber stopper and aluminium cap
Għal użu taħt il - ġilda jew fil - muskolu.
250ml
Fliexken tal - ta ’ ħġieġ, 250ML ta ’ klassi idrolitika tip II, magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum
1 bottle Zero days
Flixkun Xejn wiehed
500ml
Fliexken tal - ta ’ ħġieġ, 500ML ta ’ klassi idrolitika tip II, magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum
Intramuscular PET bottles with or rubber stopper and subcutaneous aluminium cap
Għal użu taħt il - ġilda jew fil - muskolu.
500ml
Fliexken tal- poli- etilin 500ML tereftalejt (PET). magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum fuqha.
1 bottle Zero days
Flixkun wiehed
CVMP/ 144443/ 07 1/ 1
Xejn
Nobilis Influenza H7N1 emulsion for injection
Nobilis Influenza H7N1 emulsjoni għal injezzjoni
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/ CK/ Italy/ 473/ 99), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Antiġen sħiħ inattivat tal- virus tal- influwenza avjarja, subtip H7N1 (strejn, A/ CK/ Italy/ 473/ 99), li jinduċi titru ta ’ HI ta ’ ≥6. 0log2, kif ittestjat għat- test ta ’ potenza.
For a list of excipients see section 6.1
Adjuvant Paraffina likwida ħafifa 234. 8mg/ 0. 5ml Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.
Għal immunizzazzjoni attiva fil- flieles u l- papri kontra l- Influwenza avjarja tip A, subtip H7N1.
Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals. -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Fil- flieles, tnaqqis ta ’ sinjali kliniċi, mortalita u tneħħija tal- virus wara tlaqqiegħ mal- vaċċin ġew murija fi żmien ġimgħatejn wara t- tilqima waħda Fil- papri, tnaqqis fit- tneħħija tal- virus ġew murija fi żmien ġimgħatejn wara tilqima waħda
Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Għalkemm ma ġietx investigata b’ din l- istrejn partikulari A1, studji mwettqa bi strejns oħra juru li anti- korpi fis- sirum hu mistenni li jippersistu għal tal- anqas 12 – il xahar wara amministrazzjoni ta ’ żewg dożi tal- vaċċin.
The duration of immunity in ducks is unknown.
Iż- zmien ta ’ kemm iddum l- immunita fil- papri mhix magħrufa.
2 4.4 Special warnings for each target species
2 Din it- tilqima ġiet ittestjata għas- sigurta tagħha fil- flieles u informazzjoni fuq is - sigurta fil - papri hija biss sapportiva.
The level of efficacy for other species may differ from that observed in chickens.
Il - livell ta ’ effikaċja fi speċi oħra jista ’ jkun differenti minn dak osservat fil- flieles.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Il- livell ta ’ effikaċja milħuq jista ’ jvarja u jiddependi fuq kemm hemm xebh antiġeniku bejn l - istrejn tal- vaċċin u l- istrejn li jinsab jiċċirkola.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il- prodott tista 'tikkawża nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l- bżonn li jinqata 'xi subgħa.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata mal - ewwel u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata l- parti fejn seħħet l - injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa u t- tendin tal- muskolu.
Safety has been assessed on the basis of results in chickens.
Is- sigurta tal- prodott ġiet maħduma abbażi ta ’ riżultati fil- flieles.
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Nefħa mifruxa ta ’ natura temporanja tista ’ sseħħ fil- post tat- tilqima f’ 50% tal- annimali, li tippersisti għal madwar 14 il - ġurnata.
Supportive data in ducks suggest that minor local swellings may occur at the injection sites but disappear within 3 weeks.
Studji sapportivi fil- papri juru li nefħa lokalizzata tista ’ sseħħ fil- post tat- tilqima li tinżel fi żmien 3 ġimgħat.
It is recommended to use a closed multidose vaccination system.
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
3 Chickens
3 Ħalli t- tilqim jilħaq temperatura ta ’ 15oC – 25oC u ħawwad tajjeb qabel tuża ’.
From 8 to 14 days old:
Flieles li għandhom minn 8 - 14 il- ġurnata:
0.25 or 0.5 ml subcutaneously or intramuscularly
0. 25ml jew 0. 5ml taħt il- ġilda jew fil - muskolu.
0.5 ml subcutaneously or intramuscularly
0. 5ml taħt il- ġilda jew fil- muskolu.
Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Tiġieġ li se jinżammu għall- bajd jew għat- tgħammir, għandhom jingħataw tilqima oħra 4 – 6 ġimgħat wara l- ewwel waħda.
Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Tilqim ta ’ frieh minn tjur imlaqqma, għandu għaldaqstant jittawwal sakemm dawn il - antikorpi jkunu tbaxxew.
Ducks
Papri
From 2 to 6 weeks:
Papri li għandhom minn 2 - 6 ġimghat:
0.5 ml subcutaneously or intramuscularly.
0. 5ml taħt il- ġilda jew fil- muskolu.
A dose of 1 ml is advised.
Papri li se jinżammu għall- bajd jew għat- tgħammir, għandhom jingħataw tilqima oħra 6 – 10 ġimgħat wara l- ewwel waħda. Do\ a ta ’ 1mL hija rakkomandata.
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H7N1.
Il- vaċċin jistimula immunita attiva kontra l- virus tal- Influwenza Avjarja tip A, subtip H7N1.
If the circulating avian influenza field virus has a different H and/ or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect haemagglutinin and/ or neuraminidase antibodies.
Jekk il- virus tal- influwenza avjarja li qed jiċċirkula fil- beraħ għandu l- komponent H u/ jew N tiegħu differenti mill- H7N1, inkluż fil- vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf il -] aemagglutinin jew/ u antikorpi Nuraminidejs.
Liquid light paraffin Polysorbate 80 Sorbitane mono-oleate Glycine
4 Paraffina likwida ħafifa Polisorbejt 80 Sorbitejn mono- olejt Glajċin
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL – 5831 AN Boxmeer The Netherlands.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL - AWTORIZZAZZJONI
14-05-2007
5 14. 05. 2007
The import, sale, supply and/ or use of Nobilis Influenza H7N1 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provista u / jew l- użu ta 'Nobilis Influenza H7N1 huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l - politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Nobilis Influenza H7N1 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Nobilis Influenza H7N1 għandha tikkonsulta ma ’ l - Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
5 The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
L- użu ta ’ dan il- prodott mediċinali veterinarju jitħalla jsir biss taħt kundizzjonijiet partikulari stabbiliti mill- leġislazzjoni tal- Komunita Ewropeja dwar il- kontroll tal- Influwenza Avjarja.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l - Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. < MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S - SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L - UŻU SIGUR U EFFETTIV
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MIS- SID L- AWTORIZZAZZJONI TAL- KUMMERĊ
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Sid l- Awtorizzazzjoni tal- Kummerċ għandu jinforma lill- Kumissjoni Ewropeja dwar pjanijiet ta ’ kummerċjalizzazzjoni ta’ dawn il- prodotti mediċinali li huma awtorizzati b’ din id - deċiżjoni.
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Skond l- Artikolu 71 tad- Direttiva 2001/ 82/ KEE tal- Parlament Ewropew u tal- Kunsill, l- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, il- bejgħ, il- forniment u/ jew l - użu tal- prodott mediċinali veterinarju fit- territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l - implimentazzjoni ta ’ programmi nazzjonali għad- djanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal - kontaminazzjoni f ’ annimali ħajjin jew fl- ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
L- użu ta ’ dan il- prodott mediċinali veterinarju jitħalla jsir biss taħt kundizzjonijiet partikulari stabbiliti mill- leġislazzjoni tal- Komunita Ewropeja dwar il- kontroll tal- Influwenza Avjarja.
8 D.
8 C.
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
Dawn is- sustanzi li jinstabu fil- prodott finali huma nklużi fl- Anness II tar- Regolament tal - Kunsill (KE) Nru 2377/ 90:
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Sid l- Awtorizzazzjoni tal- Kummerċ għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
ANALYTICAL ASPECTS
II ASPETTI KWALITATTIVI
STARTING MATERIALS II. C.2
MATERJAL TAL- BIDU
Not listed in a Pharmacopoeia
II. C. 2 Mhux fil- lista tal- Farmakopeja
The Applicant should provide a list of any changes to the source countries for the pigs used as a source of the porcine starting material in tryptose.
L- applikant għandu jipprovdi lista ta ’ tibdil tal- postijiet li jintużaw bħala sors tal - qżieqeż li jintużaw bħala s- sors tal- materjal tal- bidu għat- tryptose.