qanastek/EMEA-V3 huggingface dataset:
Store and transport refrigerated (2ºC - 8°C).
Aħżen u ttrasporta refriġirat (2°C – 8°C).
Protect from light.
Ipproteġi mid- dawl
500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held in place with an aluminium seal with centre hole.
Flixkun artab tal- high density polyethylene (HDPE) ta ’ 500 ml magħluq b’ tapp tal- gomma klorobutil miżmum f’ postu b’ siġill tal- Aluminjum b’ toqba fin- nofs.
Pack Sizes 1 x 500ml 6 x 500ml Not all pack sizes may be marketed
1 x 500 ml 6 x 500 ml Mhux id- daqsijiet kollha tal- pakketti jistgħu qegħdin fis- suq.
4 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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 5831AN Boxmeer The Netherlands
Wim de Korverstraat 35 5831 AN Boxmeer Olanda
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance(s)
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
Schering-Plough Animal Health 33 Whakatiki Street Upper Hutt New Zealand
Schering- Plough Animal Health Schering- Plough Animal Health 33 Whakatiki Street Upper Hutt New Zealand
S-P Veterinary Ltd Breakspear Road South Harefield Uxbridge UB9 6LS United Kingdom
S- P Veterinary Ltd Breakspear Road South Harefield Uxbridge UB9 6LS Renju Unit
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju li jingħata fuq preskrizzjoni veterinarja.
According to Article 71 of Directive 2001/ 82/ EC 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:
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:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) 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;
Pharmacologically
Sustanza( i) farmakoloġikament attiva( i)
All food producing species
Kull speċi għall- ikel
2377/ 90
Aness II tar- Regolamenti tal- kunsill (KE) No. 2377/ 90
Formaldehyde
Formalina
Mineral oil
Żejt minerali
2377/ 90.
Triethanolamine (f`dożi sa 0. 25mg/ kg piż ħaj) ma jaqax taħt l- iskop tar - Regolamenti tal- kunsill (KE) No. 2377/ 90
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Netvax Emulsion for injection for chickens
Netvax Emulsjoni għall- injezzjoni għat- tiġieġ
Per dose of 0.5ml:
F’ kull doża ta ’ 0. 5 ml:
Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU* Light mineral oil:
Toksojd Clostridium perfringens Tip A alpha: ≥ 6. 8 IU *
0.31 ml Thiomersal:
0. 31ml Thiomersal:
0.035-0.05 mg
0. 035- 0. 05mg
Vaccine against necrotic enteritis
Tilqim kontra l- enterite` nekrotika.
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI Injezzjoni fil- muskolu.
Shake well before use.
Ħallat tajjeb qabel tuża.
Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel tuża ’.
Accidental injection is dangerous – read package leaflet before use.
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif li jinsab fil- pakkett qabel tuża'
EXP month/ year Once opened, use immediately
Jiskadi {xahar / sena} La darba jinfetaħ uża mill- ewwel.
Do not freeze Protect from light
Aħżen u ttrasporta refriġirat Tiffriżax Ipproteġi mid- dawl
Disposal: read package leaflet
Rimi: aqra l- fuljett tat- tagħrif
To be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss Għandu jingħata biss bi preskrizzjoni veterinarja.
Batch {number}
Lott{ numru}
13 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU* Light mineral oil:
Clostridium perfringens toksojd Tip A alpha: ≥ 6. 8 IU *
Intramuscular use.
Injezzjoni fil- muskolu.
Withdrawal period:
Żmien ta 'tiżmim:
Do not freeze Protect from light
Aħżen u ttrasporta refriġerat (20C - 80C) Tiffriżax Ipproteġi mid- dawl
MANUFACTURER’ S BATCH NUMBER
FULJETT TA 'TAGĦRIF FIL- PAKKETT
PACKAGE LEAFLET
16 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
S-P Veterinary Ltd Breakspear Road South Harefield Uxbridge Middlesex, UB9 6LS United Kingdom
S- P Veterinary Ltd Breakspear Road South Harefield Uxbridge Middlesex, UB9 6LS Renju Unit
Clostridium perfringens Type A alpha toxoid Adjuvant
Toksojd Clostridium perfringens tip A alpha
Light Mineral Oil Excipients
Mhux inqas minn 6. 8 IU *
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis.
Biex tnaqqas l- imwiet u l- inċidenza u s- severita` tal- feriti tal- enterite` nekrotika ikawżati minn Clostridium perfringens tip A.
Efficacy was demonstrated by challenge of chicks approximately three weeks after hatching.
L- effikaċja ġiet murijha b`challenge fil- flieles madwar tlett ġimgħat wara li faqqsu
18 The onset of passive transfer of immunity:
17 It- trasferiment passiv ta’ immunita` jintlaħaq:
6 weeks following completion of the vaccination procedure
6 ġimgħat wara li jitlesta l- proċedura ta’ vaċċinazzjoni
CONTRAINDICATIONS
5 KONTRAINDIKAZZJONIJIET
Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days.
Il- vaċċinazzjoni tista` twassal għal nefħa moderata fis- sidra li tinżel fi żmien 30 ġurnata.
Following the second vaccination swelling may persist for at least 35 days.
Wara t- tieni vaċċinazzjoni in- nefħa tista` ddum sa tal- anqas 35 ġurnata.
After administration of a double dose, local reactions may increase slightly.
Wara li tingħata doża doppja, reazzjonijiet lokali jistgħu jiżdiedu xi ftit.
One dose of 0.5 ml should be given at 10 to 14 weeks of age.
Laqqam it- tiġieġ fil- muskolu tas- sider Doża waħda ta’ 0. 5ml għandha tingħata bejn 10 u l - 14 ġimgħa ta`ħajja.
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination.
It- tieni doża ta’ 0. 5ml għandha tingħata bejn 4 u l - 10 ġimgħa wara l- ewwel vaċċinazzjoni.
The second dose should be administered no later than 6 weeks before the onset of lay.
It- tieni vaċċinazzjoni għandha tingħata mhux aktar tard minn 6 ġimgħat qabel jibdew ibidu.
Protect from light.
Aħżen u ttrasporta refriġirat (2°C – 8°C) Ipproteġi mid- dawl Tużax wara d– data ta’ skadenza fuq il- pakett.
Shelf-life after first opening the immediate packaging: - Use immediately
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur immedjat għall- ewwel darba – Uża mill- ewwel
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– il siegħa, wara l- eżami mediku, erġa 'kellem lit- tabib.
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.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar kemm dan it- tilqim jaqbel ma ’ tilqim ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Għaldaqstant is- sigurtà u l - effiċjenza ta ’ dan il- prodott ma ġietx iddimostrata meta jintuża ma ’ prodott ieħor (kemm meta jintuża fl- istess jiem jew f’ xi żmien).
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national 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
To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis.
Biex jistimola l- immunita ’ attiva fit- tiġieġ sabiex jagħti protezzjoni passiva lill- flieles tagħhom kontra l- enterite` nekrotika ikkawżata minn Clostridium perfringens Tip A.
1 x 500ml 6 x 500ml Not all pack sizes may be marketed
1 x 500 ml 6 x 500 ml Mhux id- daqsijiet kollha tal- pakketti jistgħu qegħdin fis- suq.
NOBILIS INFLUENZA H5N2
INFLUWENZA NOBILIS H5N2
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 għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
If you need more information about how this product may be used, you should consult your national veterinary authority.
Jekk teħtieġ aktar informazzjoni dwar kif jista ’ jintuża dan il- prodott, għandek tikkonsulta l - awtorità veterinarja nazzjonali tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar - rakkomandazzjonijiet ta ’ CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Nobilis Influenza H5N2?
X’ inhi l- Influwenza Nobilis H5N2?
Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it can no longer cause the disease). L- Influwenza Nobilis H5N2 huwa vaċċin li fih il- vajrus avjarju inattivat ta ’ l- influwenza H5N2 (inattivat jiġifieri li l- vajrus ġie maqtul sabiex ma jkunx jista ’ jikkawwża l- marda).
What is Nobilis Influenza H5N2 used for?
X’ inhi l- użu ta ’ l- Influwenza Nobilis H5N2?
Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza.
Nobilis Influenza H5N2 huwa vaċċin użat għat- tiġieġ sabiex jiġu protetti kontra l- influwenza avjarja.
The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds.
Il- vaċċin inaqqas is- sinjali ta 'l- influwenza u ta' tkeċċija ta 'eskrementi (tixrid) tal- vajrus mit- tjur infettat.
The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).
Il- vaċċin huwa injettat b’ mod intramuskolari (f’ muskolu) jew minn taħt il- ġilda.
The vaccine will only be used as part of an approved national disease control programme.
Il- vaċċin ser jintuża biss bħala parti minn programm nazzjonali ta ’ kontroll kontra l- mard.
This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.
Dan huwa għaliex il- kontroll ta ’ l- influwenza avjarja hija r- responsabbilità ta ’ l- awtoritajiet veterinarji nazzjonali f’ konsultazzjoni mal- Kummissjoni Ewropea.
How does Nobilis Influenza H5N2 work?
Kif taħdem l- Influwenza Nobilis H5N2?
Nobilis Influenza H5N2 is a vaccine.
L- Influwenza Nobilis H5N2 huwa vaċċin.
When it is given to chickens, the birds’ immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Meta tingħata lit- tiġieġ, 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 H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens.
Il- vajrus użat fil- vaċċin iġorr l- antiġeni H5 (haemagglutinin 5) u n- N2 (neuramidase 2).
This means that vaccinated birds make antibodies against these two antigens.
Dan ifisser li għasafar vaċċinati jipproduċu antikorpi kontra dawn iż- żewġ antiġeni.
This strain has been chosen because it protects birds against virulent H5N1 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 H5 virulenti (protezzjoni inkroċjata), filwaqt li twassal minn għasafar infettati għal dawk vaċċinati.
Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component.
Għasafar vaċċinati jistgħu jiġu differenzjati b’ identifikazzjoni minn għasafar infettati permezz ta ’ test dijanjostiku għal antikorpi kontra l- komponent N2.
This differentiation is important for disease surveillance and control.
Din id- differenzjazzjoni hija importanti għas- sorveljanza u l- kontroll tal - mard.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobilis Influenza H5N2 been studied?
Reproduction is authorised provided the source is acknowledged Kif ġiet studjata l- Influwenza Nobilis H5N2?
The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2.
Il- kumpanija wetqet studji ta 'laboratorju fuq is- sigurtà bl- użu ta' vaċċin simili ħafna għal Nobilis Influenza H5N2.
This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza.
Dan il- vaċċin għandu xi ingredjenti ugwali iżda antiġeni (vajrusis) differenti, tnejn minnhom miksuba bl- istess proċess użat għall- antiġene ta 'l- influwenza avjarja li jinsab fi Nobilis Influenza.
Studies were carried out in one-day-old and 2 to 4 week-old chickens free of any infection.
Barra minn hekk, il- kumpanija vverifikat is- sigurtà ta 'tliet lottijiet ta' produzzjoni standard ta 'Nobilis Influenza H5N2.
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N2 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 sH5N2 u dan ser jiġi evalwat.
What benefit has Nobilis Influenza H5N2 shown during the studies?
Liema benefiċċju wriet l- Influwenza Nobilis H5N2 waqt l- istudji li ġew mwettqa?
• The results of the safety studies indicated that the product is safe for chickens.
• Ir- riżultati ta ’ l- istudji dwar is- sigurtà wrew li l- prodott huwa sigur għat- tiġieġ.
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 N2 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- N2li 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 H5N2?
X’ inhu r- riskju assoċjat ma ’ l- Influwenza Nobilis H5N2?
In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.
Bħal fil- każ ta ’ bosta vaċċini bbażati fuq taħlita żejtnija tista ’ titla ’ nefħa fil- post fejn issir il - vaċċinazzjoni li tista ’ ddum għal 14 – il jum.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għall- persuna li tamministra l- mediċina jew li tiġi f’ kuntatt ma ’ l - annimal?
The vaccine contains a mineral oil.
Il- vaċċin fih żejt minerali.
The person who gives 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.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm għandu jgħaddi żmien qabel l- anninal ikun jista ’ jiġi maqtul u l- laħam jintuża għall konsum tal- bniedem (żmien ta ’ dewmien prekawtolatorju)?
Zero days The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.
Ġranet 0 Il- vaċċin ma fihx ingredjenti li jistgħu jkunu ta ’ riskju għall- konsumaturi ta ’ għasafar vaċċinati.
Why has Nobilis Influenza H5N2 been approved?
Għaliex ġiet appruvata l- Influwenza Nobilis H5N2?
The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in preventing 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.
Because of 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.
Page 2/ 3 ©EMEA 2006 Nobilis Influenza H5N2 has been authorised under “ Exceptional Circumstances”.
Paġna 2/ 3 ©EMEA 2008 Influwenza Nobilis H5N2 ġie awtorizzat taħt “ Ċirkustanzi Eċċezzjonali ”.
This means that it has yet not been possible to obtain complete information about the product.
Dan ifisser li għad ma kienx possibbli li tinkiseb informazzjoni sħiħa dwar il- prodott.
The European Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
L- Aġenzija Ewropea għall- Mediċini (EMEA) ser tirrevedi informazzjoni addizzjonali li ssir disponibbli skond skeda miftehma u dan is- sommarju ser jiġi aġġornat skond kif meħtieġ.
Other information about Nobilis Influenza H5N2:
Informazzjoni oħra dwar l- Influwenza Nobilis H5N2:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N2 to Intervet International BV on 01/ 09/ 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għall- Influweza Nobilis H5N2 lil Intervet International BV fil- 01. 09. 2006.
This summary was last updated on 05/ 09/ 2006.
Dan is- sommarju ġie aġġornat l- aħħar fil - 09. 2006.
Page 3/ 3 ©EMEA 2006
Paġna 3/ 3 ©EMEA 2008
Invented
Isem kummerċjali
Strength Pharmaceutical Target species
Qawwa
Route of
Għamla Farmaċewtika
Packaging Content Package size Withdrawal
Speċi li fuqhom Mod ta ’ għandu jintuża Amministrazzjoni l- prodott
name
Ippakkjar
Form
Kontenut
administration
Daqs tal - Perjodu pakkett ta ’ Tiżmim
HI titre ≥ Emulsion for Chickens 6.0 log2 injection per dose
HI ta ’ ≥6. 0log2
Intramuscular Glass bottles 250ml or (hydrolytical subcutaneous Type II) with rubber stopper and aluminium cap
emulsjoni għal injezzjoni
1 bottle
Flieles
Zero days
Flixkun Xejn wiehed
HI titre ≥ Emulsion for 6.0 log2 injection per dose
HI ta ’ ≥6. 0log2
Intramuscular or subcutaneous
Għal użu taħt il - ġilda jew fil - muskolu.
Glass bottles 500ml (hydrolytical Type II) with rubber stopper and aluminium cap
Fliexken tal - ta ’ ħġieġ, 500ML ta ’ klassi idrolitika tip II, magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum
Chickens
emulsjoni għal injezzjoni
Intramuscular or subcutaneous
Flieles
PET bottles with rubber stopper and aluminium cap
Għal użu taħt il - ġilda jew fil - muskolu.
250ml
Fliexken tal- poli- etilin 250ML tereftalejt (PET). magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum fuqha.
Intramuscular or subcutaneous
emulsjoni għal injezzjoni
500ml
Flieles
1 bottle
Għal użu taħt il - ġilda jew fil - muskolu.
Zero days
Fliexken tal- poli- etilin 500ML tereftalejt (PET). magħluqa b’ tapp tal - gomma u ssiġillati b’ kappa tal- aluminjum fuqha.
CVMP/ 298867/ 06
Flixkun wiehed
1/ 1
Xejn
Nobilis Influenza H5N2 emulsion for injection for chickens
Nobilis Influenza H5N2 emulsjoni għal injezzjoni għal flieles
One dose of 0.5ml contains:
Doża ta ’ 0. 5ml fiha:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/ duck/ Potsdam/ 1402/ 86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Antiġen sħiħ inattivat tal- virus tal- influwenza avjarja, subtip H5N2 (strejn A/ duck/ Potsdam/ 1402/ 86), li jinduċi titru ta ’ HI ta ’ ≥6. 0log2, kif ittestjat għat- test ta ’ potenza.
Liquid light paraffin 234.8 mg/ 0,5 ml
Adjuvant Paraffina likwida ħafifa 234. 8mg/ 0. 5ml
For a full list of excipients see section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
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.
Efficacy has been evaluated on the basis of preliminary results in chickens.
L- effikaċja kienet evalwata abbażi ta’ riżultati preliminari fil- flieles.
Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Tnaqqis ta ’ sinjali kliniċi, imwiet u t- tneħħija tal- virus wara tlaqqiegħ mal- vaċċin ġew murija fi żmien tlett ġimgħat wara t- tilqim.
Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Anti- korpi fis- sirum hu mistenni li jippersistu għal tal- anqas 12 – il xahar wara amministrazzjoni ta ’ żewg dożi tal- vaċċin.
Do not administer intramuscularly in chickens less than 2 weeks old.
Tamministrax fil- muskolu fi flieles ta ’ anqas minn ġimgħatejn.
This vaccine has been tested for safety in chickens.
Din it- tilqima ġiet ittestjata għas- sigurta tagħha fil- flieles.
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.
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 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 minn kemm jixxiebhu l- istrejn tal- vaċċin u l - istrejns jiċċirkulaw fil- beraħ.
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.
Safety has been assessed on the basis of preliminary results in chickens.
Is- sigurta tal- prodott ġiet maħduma abbażi ta ’ riżultati preliminari 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.
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.
4.8 Interactions with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor.
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- jum qabel jew wara li tlaqqam b' dan il- prodott.
For subcutaneous or intramuscular use.
Għal użu taħt il- ġilda jew fil- muskolu.
Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use.
Ħalli t- tilqim jilħaq temperatura ta ’ 15oC – 25oC u ħawwad tajjeb qabel tuża ’.
Use sterile syringes and needles.
Uża ’ siringi u labar sterili.
It is recommended to use a closed multiject vaccination system.
Huwa rakkomandat li tintuża s- sistema ta ’ ħafna tilqim fil- magħluq.
From 8-14 days old:
Flieles li għandhom minn 8 - 14 il- ġurnata:
0.25 ml subcutaneously From 14 days to 6 weeks old:
Flieles li għandhom minn 14 il- ġurnata sa sitt ġimgħat:
0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older:
0. 25ml jew 0. 5ml taħt il- ġilda jew fil- muskolu.
0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
3 Tiġieġ li se jinżammu għall- bajd jew għat- tgħammir, għandhom jingħataw tilqima oħra 4 – 6 ġimgħat wara l- ewwel waħda.
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.
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 ħafna.
Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Wara li ngħatat doża doppja, ma ġewx osservati reazzjonijiet mhux mixtieqa oħra, ħlief dawk imsemmija f’ sezzjoni 4. 6
Pharmacotherapeutic group: inactivated vaccine, ATC-vet code:
Vaċċin inattivat, Kodici ATĊ veterinarja:
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5.
Il- vaċċin jistimula immunita attiva kontra l- virus tal- Influwenza Avjarja tip A, subtip H5.
If the circulating avian influenza field virus has a different N component to the N2 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- N2, inkluż fil- vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf antikorpi Nuraminidejs.
Liquid light paraffin Polysorbate 80 Sorbitane mono-oleate Glycine
Paraffina likwida ħafifa Polisorbejt 80 Sorbitejn mono- olejt Glajċin
Do not mix with any other medicinal product.
Tħallatx ma prodotti mediċinali oħra.
PET vials:
Fjali tal- PET:
2 years Glass vials:
2 snin Fjali tal- ħġieġ:
1 year
1 sena
After broaching use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Wara li tiftaħ, uża fi żmien tmien siegħat, sakemm il- prodott ma ġiex suġġett għal temperaturi estremi jew ikkontaminat.
Store and transport refrigerated (2°C to 8°C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
6.5 Nature and composition of immediate packaging
4 6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Fliexken tal- 250 jew 500 ml, ta ’ ħġieġ, ta ’ klassi idrolitika tip II, jew tal- poli- etilin tereftalejt (PET).
The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Il- fliexken huma magħluqa b’ tapp tal- gomma u ssiġillati b’ kappa tal- aluminjum b’ kodiċi fuqha.
4 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
Any unused product or waste material should be disposed of in accordance with national 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.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL – 5831 AN Boxmeer.
EU/ 2/ 06/ 061/ 001-004
EU/ 2/ 06/ 061/ 001 - 004
The import, sale, supply and/ or use of Nobilis Influenza H5N2 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 H5N2 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 H5N2 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 H5N2 għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti 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 /
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 >
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
Name and address of the manufacturer of the biological active substance(s)
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 The Netherlands
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spain
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spain.
Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt The Netherlands
Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt The Netherlands.
a) 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
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.
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.
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 tal- Awtorizzazzjoni tal- Kummerċ għandu jinforma lil Kumissjoni Ewropeja dwar il- pjanijiet ta ’ kummerċ għal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
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 skond it- tabella li ġejja:
Pharmacologically active substance Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine
Paraffina likwida ħafifa Polisorbejt 80 Sorbitan mono- olejt (E 494) Glajsin
Animal Species All food producing species All food producing species All food producing species All food producing species
L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu L- ispeċi kollha li jittieklu
Other provisions
SPEĊIFIĊI
E.
SID
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
L- AWTORIZZAZZJONI
The Marketing Authorisation Holder shall complete the following programme of studies, 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 'studjiu r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena..
More detailed information on the specific obligations is set out in the CVMP assessment report.
Aktar informazzjoni dettaljatatal- obbligi speċifiċi qegħdin fir- rapport ta ’ stima tal- KPMV.
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- applikant għandu jipprovdi lista ta ’ postijiet li huma tajba bħala sors tal- qżieqeż li jintużaw bħala s- sors tal- materjal tal- bidu għat- tryptose.
Tryptose and NZ-Amines:
Tryptose u Amini NZ:
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.
Postijiet ta ’ oriġini li m’ humiex speċifikati għall- baqar li jipprovdu l- ħalib u sorsi mhux identifikati ta ’ tryptose u amini NZ, mhux ikkunsidrat aċċettabbli.
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.
Għandha tiġi pprovduta nformazzjoni aġġornata fuq il- postijiet ta ’ oriġini minn fejn jiġu l- annimali li jipprovdu l- ħalib għal preparazzjoni tat- tryptose minn BD Biosciences, u għal preparazzjoni ta ’ kaseina, u lattosju fejn hu proprju, sabiex jiġu manifatturati l- Amini NZ, mixtrija mingħand Quest / Kerry.
The Applicant should agree to only source Tryptose and (specified) NZ-Amines from specified companies from whom suitable ‘ milk statements’ have been submitted in the dossier, together with details of the countries of origin of the source animals.
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.
Revised supporting TSE compliance tables will be required.
Tabelli riveduti li juru qbil mas- sistemi ta ’ TSE huma rikjesti.
Test for identification:
Test għal identifikazzjoni:
A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition.
Għandu jiġi ntrodott test tal- lott finali tal- prodott sabiex jidentifika il - komponent nuraminidejs u jikkonferma li l- vaċċin għandu l- kompożizzjoni korretta.
A proposal is required.
Proposta f’ dan is- sens hija mitluba.
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.
L- antiġen għandu jiġi maħżun għal mhux aktar minn tnax – il xahar f’ temperatura ta ’ 2oC – 8oC, dejjem sakemm ma jingħatax aktar tagħrif li jappoġġja perjodu itwal ta ’ ħażna.
8 EFFICACY ASPECTS
8 ASPETTI T’ EFFIKAĊJA
As far as possible batch protocols, and especially potency test results, should be provided for all batches of H5N2 vaccine used in the efficacy trials presented in the dossier.
Sakemm huwa possibbli, protokolli tal- lott, speċjalment ir- riżultati tat- test tas- saħħa, għandhom jingħataw għall- lottijiet kollha tal- vaċċin H5N2, li ntużaw fil- provi t’ effikaċja, ppreżentati fid - dossjer.
The response should indicate which trials the various batches were used for.
Ir- rispons għandu jindika f’ liema provi ntużaw il- lottijiet differenti.
On the basis of this, a justification should be provided for the minimum potency specified for the product.
Abbażi ta ’ dan, għandha tigħata ġustifikazzjoni għall- qawwa minima speċifikata għall- prodott.
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 u rappurtaġġ ta ’ tagħrif miġbur fil- beraħ, f’ relazzjoni ma ’ effetti mhux mixtieqa suspettati, inkluż nuqqas t’ effikaċja.
CARTON {250ml Bottle / 500ml Bottle}
Pakkett tal- kartuna Flixkun ta ’ 250ml / 500ml
Nobilis Influenza H5N2 Emulsion for injection
Nobilis Influenza H5N2 Emulsjoni għal injezzjoni
One dose of 0.5 ml contains:
Doża ta ’ 0. 5ml fiha:
Liquid light paraffin 234.8 mg/ 0.5 ml
Adjuvant Paraffina likwida ħafifa 234. 8mg/ 0. 5ml
250 ml 500 ml
250ml 500ml
Active immunisation against avian influenza type A, subtype H5.
Għal immunizzazzjoni attiva fil- flieles kontra l- Influwenza avjarja tip A, subtip H5.
Intramuscular or subcutaneous injection of 0.25 to 0.5 ml, depending on the age.
Titqiba fil- muskolu jew taħt il- ġilda ta ’ 0. 25ml sa 0. 5ml, skond l- eta ’.
Withdrawal period - Zero days
Xejn
Accidental self-injection is dangerous
Jekk tinjetta bi żball huwa perikoluż.
< EXP {month/year} > Once broached, use within 8 hours.
Jiskadi {xahar / sena} La darba jinfetaħ uża fi żmien 8 siegħat
Store and transport refrigerated (2°C to +8°C).
Aħżen u ttrasporta ġo friġġ (2oC – 8oC).
For disposal read the package leaflet.
Dwar ir- rimi, aqra l- fuljett informattiv ġewwa l- pakkett.
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 huwa permess taħt kundizzjonijiet partikulari stabbiliti mill- leġislazzjoni tal- Kommunita Ewropeja dwar il- kontroll tal- Influwenza Avjarja.
Lot {number}
Lott {Nru.}
13 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
BOTTLE LABEL {250ml/ 500ml}
Tikketta tal- flixkun {250ml / 500ml}
250 m l 500 ml
250ml 500ml
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
< Lot > {number}
Lott {numru}
Nobilis Influenza H5N2 emulsion for injection
Nobilis Influenza H5N2 emulsjoni għal injezzjoni
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
The Netherlands
Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
The Netherlands
Nobilis Influenza H5N2 Emulsion of injection
Nobilis Influenza H5N2 emulsjoni għal injezzjoni
On dose of 0.5 ml contains:
Doża ta ’ 0. 5ml fiha:
Liquid paraffin
Adjuvant Paraffina likwida ħafifa 234. 8mg/ 0. 5ml
Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Tnaqqis ta ’ sinjali kliniċi, imwiet u tneħħija tal- virus wara tlaqqiegħ mal- vaċċin ġew murija fi żmien tlett ġimgħat wara t- tilqim.
Do not administer intramuscularly in chickens less than 2 weeks old.
Tamministrax fil- muskolu fi flieles ta ’ anqas minn ġimgħatejn
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.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MODI U METODU TA 'AMMINISTRAZZJONI
0.25 ml subcutaneously
0. 25ml taħt il- ġilda
From 14 days to 6 weeks old:
Flieles li għandhom minn 14 il- ġurnata sa sitt ġimgħat:
0.25 or 0.5ml subcutaneously or intramuscularly
0. 25ml jew 0. 5ml taħt il- ġilda jew fil- muskolu.
6 weeks and older:
Minn sitt ġimgħat ‘ il fuq:
0.5ml 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.
Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Ħalli t- tilqim jilħaq temperatura ta ’ 15oC – 25oC u ħawwad tajjeb qabel tuża ’.
Store and transport at +2°C to +8°C.
Aħżen u ttrasporta fil- friġġ (2°C – 8°C).
After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Aħżen fil- friġġ (2°C – 8°C) Wara li tiftaħ, uża fi żmien 8 siegħat, sakemm il- prodott mhux suġġett għal temperaturi estremi, jew ġie kkontaminat.
Do not use after the expiry date which is stated on the label.
Tużax wara d- data tal- iskadenza fuq it- tikketta.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor.
It is therefore recommended that no other vaccines should be administered 14 days before or after vaccination with the product.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fi żmien 14 il- jum qabel jew wara li tlaqqam b' dan il- prodott.
Do not mix with any other medicinal product.
Tħallatx, ma ebda prodott mediċinali ieħor.
Special warning for the user:
Għal min se juża:
18 Pack sizes:
Daqsijiet tal- pakketti:
250 or 500 ml multidose glass bottle 250 or 500 ml multidose PET bottle The bottles are closed with a rubber stopper and an aluminium cap.
Fliexken tal- ħġieġ ta ’ aktar minn doża waħda li jesgħu 250 jew 500ml Fliexken tal- PET ta ’ aktar minn doża waħda li jesgħu 250 jew 500ml Il- fliexken huma magħluqa b’ tapp tal- gomma u kappa tal- aluminjum.
NOBILIS INFLUENZA H5N6
INFLUWENZA NOBILIS H5N6
This document cannot replace a face-to-face discussion with your veterinarian.
L - għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ aktar informazzjoni dwar kif jista ’ jintuża dan il- prodott, għandek tikkonsulta l - awtorità veterinarja nazzjonali tiegħek.
What is Nobilis Influenza H5N6?
X’ inhi l- Influwenza Nobilis H5N6?
Nobilis Influenza H5N6 is a vaccine containing an inactivated avian influenza virus H5N6 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Nobilis Influenza H5N6 is a vaccine containing an inactivated avian influenza virus H5N6 (inactivated means that the virus has been killed so that it can no longer cause the disease). L- Influwenza Nobilis H5N6 huwa vaċċin li fih il- vajrus avjarju inattivat ta ’ l- influwenza H5N6 (inattivat jiġifieri li l- vajrus ġie maqtul sabiex ma jkunx jista ’ jikkawwża l- marda).
What is Nobilis Influenza H5N6 used for?
Għal xiex jintuża Nobilis Influenza H5N6?
Nobilis Influenza H5N6 is a vaccine used in chickens to protect against avian influenza.
Nobilis Influenza H5N6 huwa vaċċin użat għat- tiġieġ sabiex jiġu protetti kontra l- influwenza avjarja.
How does Nobilis Influenza H5N6 work?
Kif taħdem l- Influwenza Nobilis H5N6?
Nobilis Influenza H5N6 is a vaccine.
L- Influwenza Nobilis H5N6 huwa vaċċin.
The virus used for the vaccine carries the H5 (haemagglutinin 5) and N6 (neuramidase 6) antigens.
Il- vajrus użat fil- vaċċin iġorr l- antiġeni H5 (haemagglutinin 5) u n- N6 (neuramidase 6).
Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N6 component.
Għasafar vaċċinati jistgħu jiġu differenzjati b’ identifikazzjoni minn għasafar infettati permezz ta ’ test dijanjostiku għal antikorpi kontra l- komponent N6.