qanastek/EMEA-V3 huggingface dataset:
A revised supporting TSE compliance table should be provided with deletion of the words ‘ or equivalent ’ after the source companies for the tryptose and NZ-Amines and ‘ e. g.’ before the corresponding lists of source countries.
Għandha tiġi pprovduta tabella li tappoġġja l- qbil mas- sistemi ta ’ TSE u jitħassru l- kliem “ jew ekwivalenti ” wara l- kumpaniji tas- sors għat- tryptose u Amini NZ u “ eg ” qabel il - lista korrispondenti ta ’ pajjiżi tas- sors..
An up-to-date certificate of suitability should be provided for Rousselot Acid hide gelatin (European origin) II. E.
Rousselot Acid (Oriġini
CONTROL TESTS ON THE FINISHED PRODUCT II. E.2
TESTIJIET TA ’ KONTROLL FUQ IL PRODOTT LEST
Identification and assay of active ingredients
II. E. 2 Identifikazzjoni u stima tas- sustanza attiva
F.
Ġustifikazzjoni ċara għandha tingħata li tissaportja il- livell aċċettabli propost ta ’ HI tajter tas - serum ta ’ 6. 0log2.
Stability of the bulk antigen
II. F STABBILITA II. F. 1 Stabillita tal- bulk antiġen
SAFETY ASPECTS 6.
ASPETTI TA ’ SIGURTA
The report of the overdose safety studies in ducks with Nobilis Influenza H7N1 administered by both s. c. and i. m. routes should be provided as soon as it is available
Rapporti fuq studji tas- sigurta` ta ’ amministrazzjoni ta` doża waħda kif ukoll ta ’ doża eċċessiva
9 PHARMACOVIGILANCE ASPECTS
ASPETTI TA ’ FARMAKOVIĠILANZA
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
EFFICACY ASPECTS 8.
ASPETTI T’ EFFIKAĊJA
Batch release data for all batches of H7N1 vaccine used in the efficacy trials presented in the dossier and justification for the potency release criteria should be provided.
Għandha tiġi pprovduta l- informazzjoni tar- rilaxx tal- lottijiet kollha tal- vaċċin H7N1 li ntużaw fil - kriterja sabiex ta ’ kontrokorpi
The distinction between what might be protective titres of antibodies and the level of antibodies generated under the conditions of the batch potency test should be taken into account and the minimum potency at the time of batch release should be sufficient to provide the claimed duration of immunity.
Id- distinzjoni bejn x’ jistgħu ikunu tajters protettivi u l- livell ta ’ kontrokorpi ġġenerat taħt il- kundizzjonijiet tat- test tas- saħħa
Nobilis Influenza H7N1 Emulsion for injection
Nobilis Influenza H7N1 Emulsjoni għal injezzjoni
Active immunisation against avian influenza type A, subtype H7N1.
Għal immunizzazzjoni attiva fil- flieles kontra l- Influwenza avjarja tip A, subtip H7N1.
I. M. or S. C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species.
Titqiba fil- muskolu jew taħt il- ġilda ta ’ 0. 25ml, 0. 5ml jew 1. 0ml skond l- eta ’.
13 9.
Xejn
Read the package leaflet before use.
Qabel l- użu aqra l- fuljett.
Read the package leaflet before use.
Aqra l- fuljett informattiv ġewwa l- pakkett qabel tu\ a l- prodott.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L - UŻU, jekk applikabbli
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ
EU/ 2/ 07/ 073/ 001-004
14 EU/ 2/ 07/ 073/ 001- 004
14 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
I. M. or S. C. injection Read the package leaflet before use.
Titqiba fil- muskolu jew taħt il- ġilda Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
< Lot > {number}
15 Lott {numru}
16 PACKAGE LEAFLET FOR:
FULJETT TA 'TAGĦRIF FIL- PAKKETT
Nobilis Influenza H7N1 emulsion for injection
Nobilis Influenza H5N2 emulsjoni għal injezzjoni
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
1 L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL - KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS - SUQ, JEKK DIFFERENTI
Nobilis Influenza H7N1 Emulsion of injection
Nobilis Influenza H7N1 emulsjoni għal injezzjoni
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- papri, tnaqqis fit tneħħija tal- virus ġew murija fi żmien ġimgħatejn wara t- tilqima wa] da G] alkemm ma [ietx investigata b’ din l- istrejn partikulari A1, studji mwettqa b’ istrejns o] ra juru li
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.
18 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.
I\ - zmien ta ’ kemm idum l- imunita fil- papri mhix mag] rufa.
Safety has been assessed on the basis of results in chickens.
Is- sigurta tal- prodott ġiet maħduma abbażi ta ’ riżultati preliminari fil- flieles.
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 tin\ el fi\ mien 3 [img] at.
If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
Chickens From 8 to 14 days old:
Flieles li għandhom minn 8 - 14 il- ġurnata:
0.25 or 0.5ml subcutaneously or intramuscularly
0. 25ml jew 0. 5ml taħt il- ġilda jew fil - muskolu.
Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
19 Ħalli t- tilqim jilħaq temperatura ta ’ 15oC – 25oC u ħawwad tajjeb qabel tuża ’.
It is recommended to use a closed multidose vaccination system.
Huwa rakkomandat li tintuża s- sistema ta ’ ħafna tilqim fil- magħluq.
Store and transport at 2°C to 8°C.
Aħżen u ttrasporta fil- friġġ (2°C – 8°C).
This vaccine has been tested for safety in chickens and only supportive data for safety in ducks are available.
Din it- tilqima ġiet ittestjata għas- sigurta tagħha fil- flieles u informazzjoni fuq is - sigurta fil - papri hija biss sapportiva..
This product contains mineral oil.
20 Dan il- prodott fih żejt minerali.
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 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 Hu/ 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 antikorpi Nuraminidejs.
What is Nobilis OR Inac?
X’ inhu Nobilis OR Inac?
Nobilis OR Inac is a vaccine that contains a suspension of the bacterium Ornithobacterium rhinotracheale serotype A, strain B3263/ 91.
Nobilis OR Inac huwa vaċċin li fih sospensjoni tal- batterju Ornithobacterium rhinotracheale serotip A, razza B3263/ 91.
The bacterium has been inactivated (treated to make it unable to cause an illness).
Il- batterju jiġi inattivat (ittrattat b’ mod li ma jibqax kapaċi jikkawża mard).
Nobilis OR Inac is an emulsion (a mixture of oil- and water-based liquids) for injection.
Nobilis OR Inac hu emusljoni (taħlita ta ’ likwidi b’ bażi ta ’ żejt u ilma) għall - injezzjoni.
What is Nobilis OR Inac used for?
Għalxiex jintuża Nobilis OR Inac?
Nobilis OR Inac is used to vaccinate female chickens that are being used for breeding broilers (chickens bred for meat) against the bacterium O. rhinotracheale serotype A.
Nobilis OR Inac jintuża fit- tilqim ta ’ tiġieġ li jkun qed jitrabba għal- laħam kontra l- batterju O. rhinotracheale serotip A.
This immunity is then passed on to the chickens’ offspring, so that the broilers are protected against infection with the same type of bacteria.
Din l- immunità mbagħad tgħaddi lill- frieħ tat- tiġieġ, ħalli l- brojlers ikunu protetti kontra infezzjoni bl- istess tip ta ’ batterji.
Infection with O. rhinotracheale can cause respiratory diseases and death.
L- infezzjoni b’ O. rhinotracheale tista ’ tikkawża mard tan- nifs u anke toqtol.
Nobilis OR Inac is given as two 0.25-ml injections, either under the skin in the neck or into the breast muscle.
Nobilis OR Inac jingħata bħala żewġ injezzjonijiet ta ’ 0. 25- ml, jew taħt il- ġilda fil- għonq jew fil- muskolu tas- sider.
The first injection is given at an age of six to 12 weeks and the second at least six weeks later at an age of 14 to 18 weeks.
L- ewwel injezzjoni tingħata fl- età ta ’ 12- il ġimgħa u t- tieni waħda ta ’ l - inqas sitt ġimgħat iktar tard fl- età ta ’ bejn 14 u 18- il ġimgħa.
Immunity is transferred to the chicken’ s offspring for a period of 43 weeks after the last vaccination.
L- immunità tgħaddi lill- frieħ tat - tiġieġ għal perjodu ta ’ 43 ġimgħa wara l- aħħar tilqima.
In the broiler chicks, the immunity lasts until at least 14 days after hatching.
Fil- brojlers, l- immunità ddum ta ’ l - anqas 14- il jum wara t- tfaqqis.
How does Nobilis OR Inac work?
Kif jaħdem Nobilis OR Inac?
Nobilis OR Inac is a vaccine.
Nobilis OR Inac hu vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id - difiża naturali tal- ġisem) tiddefendi ruħha kontra l- mard.
Nobilis OR Inac contains small amounts of a killed bacterium called O. rhinotracheale serotype A, strain B3263/ 91.
Nobilis OR Inac fih ammonti żgħar ta ’ batterju maqtul magħruf bħala O. rhinotracheale serotip A, razza B3263/ 91.
The vaccine also contains an ‘ adjuvant’ (liquid paraffin) to stimulate a better response.
Il- vaċċin fih ukoll ‘ ajjutant ’ (żejt likwidu mhux raffinat) biex jistimula rispons aħjar.
When a breeder is given the vaccine, the immune system recognises the killed bacteria as ‘ foreign’ and makes antibodies against them.
Meta l- annimal jingħata t- tilqima, is- sistema immunitarja tagħraf lill- batterji maqtula bħala ‘ barranin ’ u jagħmel antikorpi kontrihom.
These antibodies are then passed on to the breeder’ s offspring through the eggs.
Dawn l- antikorpi jgħaddu lill- frieħ mill- bajd.
The antibodies then protect the offspring against infection with this type of bacterium.
L- antikorpi mbagħad jipproteġu lill- frieħ kontra infezzjoni b’ dan it- tip ta ’ batterju.
Reproduction is authorised provided the source is acknowledged How has Nobilis OR Inac been studied?
Reproduction is authorised provided the source is acknowledged Kif ġie studjat Nobilis OR Inac?
The effectiveness of Nobilis OR Inac has been studied in two main studies that compared the effectiveness of Nobilis OR Inac with that of no vaccination.
L- effikaċja ta ’ Nobilis OR Inac ġiet studjata f’ żewġ studji ewlenin li qabblu l- effikaċja ta ’ Nobilis OR Inac ma ’ dik tan- nuqqas ta ’ tilqima.
The studies looked at the levels of antibodies against O. rhinotracheale in the vaccinated breeders at four weeks after the second injection of the vaccine (22 weeks of age), and again at the end of the laying period (58 weeks of age).
L- istudju analizzaw il- livelli ta ’ antikorpi kontra O. rhinotracheale fit- tiġieġ imlaqqam erba ’ ġimgħat wara t- tieni injezzjoni bil- vaċċin (fl- età ta ’ 22 ġimgħa), u mill- ġdid fi tmiem il- perjodu tal- bajd (58 ġimgħa).
The studies also looked at the offspring (broilers).
L- istudji analizzaw ukoll il- frieħ (brojlers).
What benefit has Nobilis OR Inac shown during the studies?
X’ benefiċċju ta ’ Nobilis OR Inac intwera f’ dawn l- istudji?
In the study, the levels of antibodies were higher in the vaccinated breeders than in those that did not receive the vaccine, both at 22 and at 58 weeks of age.
Fl- istudju, il- livelli ta ’ antikorpi kienu ikbar fit- tiġieġ imlaqqma milli f’ dawk li ma ngħatawx tilqima, kemm fl- età ta ’ 22 ġimgħa kif ukoll fl- età ta ’ 58 ġimgħa.
The chicks of vaccinated breeders had lower death rates and produced more meat than those whose mothers had not been vaccinated.
Il- flieles tat- tiġieġ imlaqqmin kellhom rati ta ’ mewt iktar baxxi u pproduċew iktar laħam minn dawk li ommijiethom ma kinux tlaqqmu.
What is the risk associated with Nobilis OR Inac?
X’ riskju hu assoċjat ma ’ Nobilis OR Inac?
Nobilis OR Inac can cause temporary swelling at the site of injection, as well as other sporadic reactions near the injection site and affecting the whole body.
Nobilis OR Inac jista ’ jikkawża nefħa temporanja fis- sit ta ’ l- injezzjoni, kif ukoll reazzjonijiet sporadiċi oħrajn ħdejn is- sit ta ’ l- injezzjoni u jaffettwaw il- ġisem kollu.
Nobilis OR Inac should not be used in birds that are in lay (currently producing eggs).
Nobilis OR Inac m’ għandux jintuża fi frieħ li jkunu qed jipproduċu l- bajd.
Accidental injection of Nobilis OR Inac can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
L- injezzjoni aċċidentali ta ’ Nobilis OR Inac tista ’ tikkawża nefħa u uġigħ kbir, speċjalment jekk tiġi injettata f’ ġog jew seba ’.
If accidental injection happens, seek prompt medical advice and show the Package Leaflet to the doctor.
Jekk ikun hemm injezzjoni aċċidentali, kellem tabib mill - ewwel u urih il- Fuljett ta ’ Tagħrif.
If pain persists for more than 12 hours after examination, seek medical advice again.
Jekk l- uġigħ jippersisti għal iktar minn 12- il siegħa wara l - eżami mediku, erġa ’ kellem lit- tabib.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi żmien qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall - konsum mill- bniedem (withdrawal period)?
The withdrawal period is zero days.
Il- withdrawal period hu ta ’ żero ġranet.
Why has Nobilis OR Inac been approved?
Għaliex ġie approvat Nobilis OR Inac?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis OR Inac exceed the risks for passive immunistaion of broilers induced by active immunisation of female broiler breeders to reduce infection with O. rhinotracheale serotype A when this agent is involved, and recommended that Nobilis OR Inac be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Nobilis OR Inac jegħelbu r- riskji tiegħu meta użat għat- tilqim passiv ta ’ brojlers biex inaqqas l- infezzjoni b’ O. rhinotracheale serotip A meta jkun involut dan l- aġent, u rrakkomanda li Nobilis OR Inac jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r- riskju jinsab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Nobilis OR Inac:
Tagħrif ieħor dwar Nobilis OR Inac:
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis OR Inac to Intervet International on 24 January 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Nobilis OR Inac lil Intervet International fl- 24 ta ’ Jannar 2003.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it - tikketta/ pakkett ta ’ barra.
This summary was last updated on 10.01.2008.
Dan is- sommarju ġie aġġornat l- aħħar fit - 10. 01. 2008.
EU - Number
Numru tal- UE
Strength
Saħħa 1 x 107
Pharmaceutical Form
Forma Farmaċewtika
Target Species
Speċi li fuqhom jintuża l - prodot
Route of administration
Mod t’ amministrazzjoni
Packaging Content
Ippakkjar Kontenut
Withdrawal period
Żmien ta ’ iżmim
EU/ 2/ 02/ 036/ 001
EU/ 2/ 02/ 036/ 00 1
1 x 107 cells per 0.25 ml dose
ċelloli għal kull doża ta ’ 0. 25 ml 1 x 107 cells
Subcutaneous or intramuscular use
Użu taħt il- ġilda jew intramuskolari
250 ml (1000 doses)
Fjal (PET) 250 ml (1000 doża)
1 vial
Fjal 1
0 days
0 ġranet
EU/ 2/ 02/ 036/ 002
EU/ 2/ 02/ 036/ 00 2
1 x 107 cells per 0.25 ml dose
per 0. 25 ml dose
500 ml (2000 doses)
Fjal (PET) 500 ml (2000 doża)
Nobilis OR inac emulsion for injection for chickens
Nobilis OR inac emulsjoni għal injezzjoni
Per dose of 0.25 ml:
Kull doża ta ’ 0. 25ml
Active substance Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/ 91 1 x 107 cells *
Sustanza Attiva Suspensjoni ta ċelloli li fiha Ornithobacterium rhinotracheale serotip A, strejn B3263/ 91 1 x 107 ċelloli *.
* inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
* Tinduċi titru medju ta ’ mill- anqas 11. 2 (log2) għat- test ta’ potenza fil- tigieg.
Adjuvant Light liquid paraffin:
Adjuvant Paraffina likwida ħafifa
107.21 mg
107. 21mg
Excipients Traces of formaldehyde
Eċċipjenti Traċċi ta ’ formaldeħajd
For a list of excipients, see section 6.1
Għal- lista sħiħa ta ’ eċċipjenti, ara s- sezzjoni 6. 1.
Chickens
Tigieg
For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Għal immunizzazzjoni passiva ta ’ tigieg indotta b’ immunizzazzjoni attiva f’ tiġieġ tas- simna għar - razza sabiex titnaqqas l- infezzjoni bl- Ornithobacterium rhinotracheale serotip A, meta huwa involut dan l- aġent.
Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.
Fil- beraħ, immunita passiva l- immunita hija trasferite waqt żmien il- bajd fi 43 ġimgħa wara l- aħħar vaċċinazzjoni tat- tiġieġ, li tirriżulta f’ immunita passiva li ddum sa 14 – il ġimgħa war t- tifqis.
Do not use in birds in lay.
Tużax fi tjur waqt żmien il- bajd
Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
Ħallil- vaċċin jilħaq it- temperatura tal- kamra (15 – 25oC) qabel tużah.
Shake well before use.
Ħawwad tajjeb qabell- użu.
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 insert 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.
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..
In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination.
Fi studji fil- laboratorju, nefħa lokaliżżata u li tmur instabet f’ eżamijiet post- mortem f’ madwar 40% tat- tjur għalmadwar 14 – il ġurnata wara titqiba taħt il- ġilda.
Under field conditions, sporadic local and systemic clinical reactions have been reported.
F’ kundizzjonijiet fil- beraħ, reazzjonijiet kliniċi sistemiċi ġew irrappurtati.
Do not use in birds in lay (see section 4.3).
Tużax fi tjur li qed ibidu.
No information is available on the compatibility of this vaccine with any other.
M' hemmx informazzjoni dwar il- kompatinbilita ta ’ din it- tilqima ma prodotti oħra.
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Għaldaqstant is - sigurta u l- effikaċja ta ’ dan ilk- prodott meta użat ma oħrajn, (kemm jekk użat fl- istess ġurnata jew f’ ħin differenti) ma ġewx murija.
The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast.
L- iskema tat - tilqim tikkonsisti f’ żewġ injezzjonijiet b’ doża ta ’ 0. 25ml, amministrati taħt il- ġilda fl - għonq jew fil- muskolu tas- sider.
The first injection can be administered at an age of 6 - 12 weeks.
L- ewwel injezzjoni tista tingħata f’ eta ta ’ 6 – 12 – il ġimgħa.
The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
It- tieni injezzjoni għandha tingħata tal- inqas 6 ġimgħat wara f’ eta ta ’ 14 – 18 – il ġimgħa.
No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine.
Ma ġewx osservati effetti mhux mixtieqa wara amministrazzjoni ta ’ doża doppja meta kkomparat ma doża waħda tal- vaċċin.
Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21 days after vaccination.
Okkażjonalment nefħiet żgħar (0. 5 – 2. 0), lokaliżżati u iebsin ġew osservati li iżda sparixxew wara 21 ġurnata ta ’ vaċċinazzjoni.
QI 01AB07
Grupp Farmako- terapewtiku: vaċċin magħmul minn bakterjum inattivat Kodici ATĊ veterinarja QI 01 AB07
The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A.
Għal immunizzazzjoni passiva ta ’ tigieg indotta b’ immunizzazzjoni attiva f’ tiġieġ tas- simna għar - razza sabiex titnaqqas l- infezzjoni bl- Ornithobacterium rhinotracheale serotip A
Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution
Paraffina likwida ħafifa, Polisorbejt 80, Sorbitan olejt, phosphate buffered aqueous solution
Do not mix with any other vaccine/ immunological product.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
15 months Shelf life after first opening:
15 – il xahar Żmien li l- prodott jibqa ’ tajjeb wara li jinfetaħ:
Use immediately after opening
Uża mmedjatament war li tiftaħ.
Do not freeze.
Aħżen u ttrasporta ġo friġġ (2°C – 8°C) Tiffriżax
Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Kaxxa tal- kartun li fiha fjala waħda ta ’ Polyethylene Terephthalate (PET) ta ’ 250ml (1000 doża) jew 500ml (2000 doża), magħluqa b’ tapp tal- gomma u ssiġillati b’ kappa tal- aluminjum b’ kodiċi fuqha.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL – 5831 AN Boxmeer.
The import, sale, supply and/ or use of the product 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 tal- prodott 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 the product must consult the relevant Member States 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 l- prodott għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY ORUSE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manufattur( i) tas- sustanza bioloġika attiva
Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35, 5831 AN Boxmeer The Netherlands
To be supplied only on veterinary prescription.
Prott veterinarju li għandu jiġi mogħti biss bi preskrizzjoni veterinarja.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
• For the active principle of biological origin intended to produce immunity, Council Regulation (EEC) No 2377/ 90 does not apply.
2377/ 90 ma japplikax.
• The adjuvants and excipients listed are included in Annex II of Council Regulation (EEC) No 2377/ 90.
• L- adjuvanti u l- eċċipjenti mniżżla huma nklużi f’ Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90:
7 Pharmacologically active substance Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
7
Animal Species All food producing species
Sustanza farmakoloġikament
Other provisions Excludes aromatic and unsaturated compounds
Speċi ta ’
Polysorbate 80 Sodium chloride
Hidro- karboni minerali, xemgħa L- ispeċi kollha li jittieklu ta ’ viżkosita baxxa sa għolja inkluż mikro kristallina, madwar C10 – C60; Sustanzi aliċikliċi u alifatiċi bil- friegħi Polisorbejt 80 L- ispeċi kollha li jittieklu Klorid tas- sodjum L- ispeċi kollha li jittieklu
All food producing species All food producing species
Jeskludi sustanzi aromatiċi u mhux saturati.
(E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human consumption and therefore covered by Annex II of Council Regulation (EEC) No.
• Sorbitan olejt (E494), Potassium dihydrogen phosphate (E340), Disodium hydrogen phosphate (E339) u l- klorid tal- potassjum (E 508) huma approvati bħala addittivi f’ ikel għal konsum uman u għaldaqstant mdaħħla f’ Anness II tar- Regolament tal- Kunsill nru.
2377/ 90 for substances with an E- number1 (with the exception of preservatives listed in part C of Annex III to Council Directive 95/ 2/ EC2.).
2377/ 90 għal sustanzi b’ numru E- 1 (b’ eċċezzjoni ta ’ preservattivi mniżżla f’ parti Ċ t’ Anness III tad - Direttiva tal- Kunsill 95/ 2/ EC2).
1 OJ No L272 of 25.10.1996, p.
¹OJ Nru L272 tal 25. 10. 1996, p.
2 2 OJ No L 61 of 18.3.1995, p.
2 ²OJ Nru L61 tat 18. 3. 1995, p.
1
1 8 ANNESS III
Nobilis OR inac emulsion for injection for chickens
Nobivac OR inac emulsjoni għal injezzjoni
Per dose of 0.25 ml:
Kull doża ta ’ 0. 25ml:
Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/ 91 1 x 107 cells * * inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Suspensjoni ta ċelloli li fiha Ornithobacterium rhinotracheale serotip A, strejn B3263/ 91 1 x 107 ċelloli *. * Tinduċi titru medju ta ’ mill- anqas 11. 2 (log2) għat- test ta’ potenza fil- tigieg.
Light liquid paraffin:
Paraffina likwida ħafifa:
107.21 mg Traces of formaldehyde
107. 21mg Traċċi ta ’ formaldeħajd
1 PET vial with 250 ml (1000 doses) 1 PET vial with 500 ml (2000 doses)
Fjal wieħed tal- PET b’ 250ml (1000 doża) Fjal wieħed tal- PET b’ 500ml (2000 doża)
Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
Doża waħda ta ’ 0. 25ml taħt il- ġilda fl- għonq jew fil- muskolu tas- sider.
Oil adjuvanted vaccine Do not use for birds in lay.
Vaċċin b’ adjuvant ta ’ żejt Tużax fi tjur li qed ibidu.
Accidental injection is dangerous – see package insert before use.
Injezzjoni aċċidentali hija perikoluża – ara l- fuljett ta ’ tagħrif fil- pakkett qabel l- użu
Shelf life after first opening:
Jis {xahar / sena} Żmien li l- prodott jibqa ’ tajjeb wara li jinfetaħ:
Store and transport at 2 - 8°C.
Aħżen u ttrasporta minn 2 – 8oC.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
For animal treatment only -to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss Prodott mediċinali veterinarju li jiġi mogħti biss b’ riċetta veterinarja.
EU/ 2/ 02/ 036/ 001 (250 ml) EU/ 2/ 02/ 036/ 002 (500 ml)
EU/ 2/ 02/ 036/ 001 (250mls) EU/ 2/ 02/ 036/ 002 (500mls)
Lot: ……
Lott:........
12 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
12 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Nobilis OR inac emulsion for injection for chickens
Nobilis OR inac
ACTIVE SUBSTANCE(S)
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Inactivated whole cell suspension of O. rhinotracheale Light liquid paraffin
Suspensjoni ta ’ ċelloli sħaħ t ’ Ornithobacterium rhinotracheale Paraffina likwida ħafifa
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BĦLA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
250 ml (1000 doses) 500 ml (2000 doses)
250ml (1000 doża) 500ml (2000 doża)
ROUTES OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
s. c. injection or i. m. injection of one dose of 0.25 ml.
Injezzjoni taħt il- ġilda jew fil- muskolu ta ’ doża waħda ta’ 0. 25ml
0 days
Xejn ġranet
Do not use for birds in lay.
Tużax fi tjur li qed ibidu.
Accidental self-injection is dangerous – see package insert
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett
(Month/ Year) …… /…..
(xahar / sena)..... /.........
Use immediately
La darba jinfetaħ uża mmedjatament
Do not freeze.
Aħżen u ttrasporta f' temperaturi ta ’ 2°C - 8°C Tiffriżax
NAME OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
ISEM L- ENTITÀ LI GĦANDHA L- AWTORIZZAZZJONI TAL- KUMMERĊ U S- SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Batch: ……
Lott:......
EU Number
NUMRU TAL- UE
EU/ 2/ 02/ 036/ 001 (250 ml) EU/ 2/ 02/ 036/ 002 (500 ml)
EU/ 2/ 02/ 036/ 001- 001 (250mls) EU/ 2/ 02/ 036/ 001- 002 (500mls)
15 PACKAGE LEAFLET
15 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA
1 L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Marketing authorisation holder and manufacturer:
Sid tal- Awtorizzazzjoni tal- kummerċ u manifattur:
Per dose of 0.25 ml:
Kull doża ta ’ 0. 25ml ta ’ prodott imħallat:
Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/ 91 1 x 107 cells *
Suspensjoni ta ċelloli sħaħ inattivati ta ’ Ornithobacterium rhinotracheale serotip A, strejn B3263/ 91 1 x 107 ċelloli *.
107.21 mg Traces of formaldehyde
Paraffina likwida ħafifa 107. 21mgs Traċċi ta ’ formaldeħajd
Do not use for birds in lay
Tużax fi tjur waqt żmien il- bajd
Single dose of 0.25 ml.
Doża waħda ta ’ 0. 25ml,
Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken.
Injezzjoni taħt il- ġilda fl- għonq jew fil- muskolu tas- sider.
Allow the vaccine to reach room temperature (15-25°C) before using the vaccine.
Ħalli l- vaċċin jilħaq it- temperatura tal- kamra (15 – 25oC) qabel tużah.
Use sterile vaccination equipment.
Uża apparat sterili għal vaċċin.
Vaccination scheme:
Skema ta ’ Vaċċinazzjoni:
Do not use after the expiry date stated on the label.
Aħżen fil- friġġ (2°C – 8°C) Tiffriżax Tużax wara d- data tal- iskadenza fuq it- tikketta.
17 To the physician:
17 Għat- Tabib:
Do not mix with any other vaccine/ immunological product.
Tħallat ma ebda tilqim jew prodott immunoloġiku ieħor
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE RIVEDUT L- AĦĦAR IL- FULJETT INFORMATTIV FIL - PAKKETT
The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A.
Il- prodott fih suspensjoni ta ċelloli sħaħ inattivati ta ’ Ornithobacterium rhinotracheale serotip A, mħallta ma adjuvant żejtni. Il- prodott jistimula immunita attiva f’ tiġieġ tas- simna għar- razza sabiex jipprovdu immunita passiva lil tagħhom kontra Ornithobacterium rhinotracheale serotip A.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
What is Nobilis IB 4-91?
X’ inhu Nobilis IB 4- 91?
Nobilis IB 4-91 is a lyophilised (freeze dried) vaccine pellet which is made into a solution for dosing.
Nobilis IB 4- 91 huwa pellit vaċċin lijofilizzat (ixxuttat bil- friża) li huwa magħmul f’ għamla ta ’ soluzzjoni għad- dożaġġ.
Nobilis IB 4-91 contains the live attenuated (altered so that it does not cause the disease) avian Infectious Bronchitis Virus (IBV).
Nobilis IB 4- 91 fih il- Virus tal- Bronkite Infettuża (IBV) ħaj attenwat tat- tjur (mibdul sabiex ma jikkawżax il- marda).
What is Nobilis IB 4-91 used for?
Għalxiex jintuża Nobilis IB 4- 91?
Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of Infectious Bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.
Nobilis IB 4- 91 jintuża sabiex it- tiġieġ jiġu immunizzati sabiex jitnaqqsu s- sinjali respiratorji ta ’ Bronkite Infettuża ikkawżata mir- razza varjant IB 4- 91, li tikkawża bronkite infettuża fit- tiġieġ.
Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration.
Nobilis IB 4- 91 jista ’ jingħata lil flieles ta ’ ġurnata u tiġieġ ikbar bi sprej rozz jew intranasali (jittieħed man- nifs mill- imnieħer) jew okulari (assorbit mill- għajnejn).
The vaccine can be given to 7-day and older chickens in their drinking water.
Il- vaċċin jista ’ jingħata lil tiġieġ ta ’ 7 ijiem u akbar fl- ilma tax- xorb tagħhom.
For long-lasting immunity, chickens should be revaccinated every 6 weeks.
Għal immunità fit- tul, it- tiġieġ għandu jiġi mlaqqam mill- ġdid kull 6 ġimgħat.
How does Nobilis IB 4-91 work?
Kif jaħdem Nobilis IB 4- 91?
Nobilis IB 4-91 contains the live IBV virus that has been attenuated (altered) so that it does not cause the disease.
Nobilis IB 4- 91 fih il- virus ħaj IBV li jkun ġie attenwat (mibdul) sabiex ma jikkawżax il- marda.
When the chickens are exposed to this attenuated virus, this small exposure helps the chickens’ immune systems to recognise and attack the IBV virus.
Meta t- tiġieġ jiġi espost għal dan il- virus attenwat, din l- espożizzjoni żgħira tgħin lis- sistema ta ’ l- immunità tat- tiġieġ tagħraf u tattakka l- virus IBV.
When exposed to IBV later in life, the chickens will either not become infected or have a much less serious infection.
Meta esposti għal IBV aktar tard f’ ħajjithom, it- tiġieġ jew ma jsirx infettat jew jista ’ jkollu infezzjoni ferm inqas serja.
How has the effectiveness of Nobilis IB 4-91 been studied?
Kif ġiet studjata l- effettività ta ’ Nobilis IB 4- 91?
The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials The vaccine was given by coarse spray to chicken of various ages.
Il- vaċċin ingħata permezz ta ’ sprej rozz lil tiġieġ ta ’ età differenti.
The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease..
Il- miżuri ewlenin ta ’ l- effettività kienu jinkludu l- iżvilupp ta ’ antikorpi għall- virus IB 4- 91, ir- rata globali ta ’ mwiet tat- tiġieġ u l- perċentwal ta ’ tiġieġ rifjutat minħabba l- marda.
Nobilis IB 4-91 vaccine has also been compared with controls, i. e. chickens that were not vaccinated.
Il- vaċċin Nobilis IB 4- 91 tqabbel ukoll mal- kontrolli, jiġifieri tiġieġ li ma ġiex imlaqqam.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 What benefit has Nobilis IB 4-91 shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 X’ benefiċċju wera Nobilis IB 4- 91 matul l- istudji?
There was a clear immune response to Nobilis IB 4-91.
Kien hemm rispons immuni ċar għal Nobilis IB 4- 91.
In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.
Fi prova waħda, wara tliet ġimgħat, 100% tat - tiġieġ żviluppaw antikorpi għall- virus IB 4- 91 meta mqabbel ma ’ 17% għall- kontrolli.
What are the side effects of Nobilis IB 4-91?
X’ inhuma l- effetti sekondarji ta ’ Nobilis IB 4- 91?
Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens.
Nobilis IB 4- 91 jista ’ jikkawża sinjali respiratorji ħfief tal- marda li jistgħu jdumu għal ftit jiem jiddependi fuq is- saħħa u l- kundizzjoni tat- tiġieġ.
There are no precautions for the person, but it is recommended that they wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
M’ hemm ebda prekawzjoni li għandha tieħu l- persuna, madankollu, huwa rrikmandat li l- persuna taħsel u tiddisinfetta idejha u l- apparat wara t- tilqim sabiex tevita li xxerred il- virus.
Why has Nobilis IB 4-91 been approved?
Għaliex Nobilis IB 4- 91 ġie approvat?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 are greater than any risks to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CVMP) qabel li l- benefiċċju ta ’ Nobilis IB 4- 91 huma akbar minn kwalunkwe riskju li tista ’ toħloq l- immunizzazzjoni tat- tiġieġ sabiex jitnaqqsu s- sinjali respiratorji ta ’ bronkite infettuża kkawżata mir- razza varjant IB 4- 91.
They recommended that Nobilis IB 4-91 should be given a marketing authorisation.
Irrikmanda li Nobilis IB 4- 91 għandu jingħata awtorizzazzjoni tal- kummerċ.
Other information about Nobilis IB 4-91:
Tagħrif ieħor dwar Nobilis IB 4- 91:
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 to Intervet International B. V. on 9 June 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni tal- kummerċ valida madwar l- Unjoni Ewropea kollha għal Nobilis IB 4- 91 lil Intervet International B. V. fid- 9 ta ’ Ġunju 1998.
Information on the prescription status of this product may be found on the labelling.
Tagħrif dwar l- istatus tal - preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketti.
Invented name
Isem mgħoti
Target Species
Speċi li jintuża l - prodott
Package size
Qies tal - pakett
Withdrwal period
Perjodu ta’ tiżmim
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Virus ħaj imma modifikat tal - Bronkite Infettiva (IBV) variant strain 4 - 91: > 3. 6 log10 EID50 *
A lyophilised vaccine pellet for reconstitution
Pritkuna lijofilizzata tat - tilqim għar - rikonstituzzjoni
For intranasal/ ocular, spray or drinking water administration
Għall - amministrazzjoni fl - imnifsejn/ għajnejn, sprej jew fl- ilma tax - xorb
1000 doses
Kunjett tal - 1000 doża ħġieġ idrolitiku tat- tip II
10 ml vial
10 ml kunjett
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Virus ħaj imma modifikat tal - Bronkite
A lyophilised vaccine pellet for reconstitution
Pritkuna lijofilizzata tat - tilqim għar -
For intranasal/ ocular, spray or drinking water administration
Għall - amministrazzjoni fl - imnifsejn/ għajnejn,
2500 doses
Kunjett tal - 2500 doża ħġieġ idrolitiku
A lyophilised vaccine pellet for reconstitution
Pritkuna lijofilizzata tat - tilqim għar - rikonstituzzjoni.
5000 doses
Kunjett tal - 5000 doża ħġieġ idrolitiku tat- tip II
vial of Type II hydrolytic glass
Kunjett tal - ħġieġ idrolitiku
10000 doses
10000 dożi
1/ 3 EU Number
1/ 3 Numru EU
vial of Type II hydrolytic glass
Kunjett tal - ħġieġ idrolitiku tat- tip II
10 x 1000 doses
10 x 1000 dożi
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Virus ħaj imma modifikat tal -
A lyophilised vaccine pellet for reconstitution
Pritkuna lijofilizzata tat -
10 x 5000 doses
10 x 5000 dożi
2/ 3 EU Number
2/ 3 Numru EU
500 doses 10 ml vial
10 ml vial
10 x 500 10 ml vial doses
10 x 500 dożi
* EID50 = 50% Embryo infective dose: the virus titre required to produce infection in 50% of the embryos inoculated.
Infettiva (IBV) variant strain 4 - 91: > 3. 6 log10 EID50 *
Nobilis IB 4-91, lyophilisate for suspension
Nobilis IB 4- 91, lajofiliżejt għal suspensjoni
Each vial contains per dose:
Kull doża fil- kunjett fiha:
Live attenuated avian Infectious Bronchitis Virus (IBV) variant strain 4-91: ≥ 3.6 log10 EID50 *
Virus ħaj imma modifikat tal- Bronkite Infettiva (IBV) variant strain 4- 91: > 3. 6 log10 EID50 *
* EID50 = 50% Embryo infective dose: the virus titre required to produce infection in 50% of the embryos inoculated.
* EID = 50% tad- doża infettiva għal embriju: it- tajter tal- virus li hu meħtieġ biex jipproduċi nfezzjoni f’ 50% tal- embriji mlaqqma.
Lyophilisate for suspension.
Lajofiliżejt għal suspensjoni
Chickens
Tiġieġ.
Active immunisation of chickens to reduce the respiratory signs of Infectious Bronchitis caused by the variant strain IB 4-91.
Immunita attiva lil flieles sabiex jitnaqqsu sinjali respiratorji tal- Bronkite Infettiva kkawżata mill- istrejn varjant IB 4- 91.
Future layers and breeders should not be vaccinated before 3 weeks of age.
4. 3 Kontra indikazzjonijiet
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
Meta jingħata Nobilis IB 4- 91 ta ’ ġurnata, jista ’ jaffetwa ħażin il - vaċċin ta ’ rinotrakeite fid- dundjani li jkun ingħata fi żmien ġimgħa u għaldaqstant din l- iskema ta ’ vaċċinazzjoni hija kontraindikata.
The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated.
Tiġieġ imlaqqma jistgħu jgħaddu l - virus tal- vaċċin lill - tiġieġ mhux imlaqqma, għalhekk wieħed għandu jieħu l - prekawzjonijiet meħtieġa biex dan ma jiġrix.
Wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Aħsel idek sewwa u iddisinfetta l- għodda wara li tivvaċċina sabiex tevita tixrid tal- virus.
Special precautions for use in animals
4. 5 Prekawzjonijiet Speċjali għall- Użu
Only healthy animals should be vaccinated.
Flieles b’ saħħithom biss għandhom jiġu mlaqqma.
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
2/ 18 Nobilis IB 4- 91 huwa ntenzjonat li jipproteġi l- flieles kontra sinjali respiratorji tal- marda kkawżata minn IBV variant strain 4- 91 biss u għaldaqstant m’ għandux jintuża minflok tilqim ieħor tal- IBV.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically
Il- prodott għandu jintuża biss wara li kien stabbilit li Nobilis variant strain IBV 4- 91 huwa epidjemjoloġikament relevanti fl- akkwata.
Care should be taken to avoid the introduction of the variant strain into an area where it is not present.
Wieħed għandu joqgħod attent li ma jintroduċix dan il- varjant f’ akkwata fejn mhux preżenti.
Care should be taken to avoid spread of the vaccine virus from vaccinated chickens to pheasants.
Wieħed għandu joqgħod attent li l - virus tal- vaċċin ma jinfirixx minn tiġieġ imlaqqma għal tjur oħra bħal faġani.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali lill - annimali
4.6 Adverse reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravita`)
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs of disease which may persist for a few days depending on the health and condition of the chickens.
Vaċċinazzjoni b ’ Nobilis IB 4- 91 jista ’ joħloq sintomi respiratorji ħfief tal- marda li jistgħu jippersistu għal xi ftit ġranet skond is- saħħa u l- kundizzjoni tal- flieles.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib u l- bajd
Nobilis IB4-91 has been shown to be safe in layers and breeders during lay.
Nobilis IB 4- 91 jista ’ jintuża f’ tiġieġ li se jkunu tal- bajd jew tar- razza jew tiġieġ li qegħdin ibidu.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days.
Meta jingħata Nobilis IB 4- 91 ta ’ ġurnata, jista ’ jaffetwa ħażin il - vaċċin ta ’ rinotrakeite (TRT) fid - dundjani li jkun ingħata fi żmien sebat ijiem.
At least 3.6 log10 EID50 (1 dose) per animal by either spray vaccination, drinking water or intranasal/ ocular administration.
Tal- inqas 3. 6 log10 EID50 (doża waħda) kull annimal jew permezz ta ’ sprej, ilma tax- xorb jew amministrazzjoni fl- imnifsejn jew fl- għajnejn.
Where the number of chickens is between the standard dosages, the next higher dosage should be used.
Meta n- numru ta’ tiġieġ jkun bejn d- dożi normali, id- doża aktar għolja li jmiss għanda tintuża.
Broiler:
Gwida:
The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ ocular administration.
Broiler: Il - vaċċin jista jiġi amministrat lil flieles ta ’ ġurnata jew aktar bħala sprej oħxon, jew bħala taqtir fl- imnifsejn jew għajnejn.
The vaccine can be administered to 7-day and older chickens by drinking water.
Il - vaċċin jista jiġi amministrat lil flieles ta ’ sebat ’ ijiem jew aktar fl- ilma tax - xorb.
For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Għal immunita fit- tul, it- tiġieġ għandhom jiġu vaċċinati mill- ġdid kull 6 ġimgħat wara l- ewwel amministrazzjoni.
Future layers and breeders:
Tiġieġ tal- bajd jew tar- razza:
The vaccine can be administered to future layers and breeders from three weeks of age onwards via intranasal/ ocular route, coarse spray or drinking water.
Il- vaċċin jista jiġi amministrat lit- tiġieġ tal- bajd u tar - razza wara li jkollhom mill- anqas tliet ġimgħat, bħala taqtir fl- imnifsejn jew għajnejn bħala sprej oħxon u fl- ilma tax- xorb
Spray method:
Sprej: