qanastek/EMEA-V3 huggingface dataset:
Orbifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative organisms.
Orbifloxaċin għandu attività in vitro kontra firxa wiesgħa ta ’ organiżmi Gram- pożittivi u Gram - negattivi.
Mometasone furoate is a corticosteroid with high topical potency but little systemic effect.
Mometasone furoate hu kortikosterojde b’ potenza topika għolja, iżda b’ effett sistemiku żgħir.
Like other topical corticosteroids, it has anti-inflammatory and anti-pruritic properties.
Bħal kortikosterojdi oħrajn, għandu proprjetajiet anti- infjammatorji u anti- pruritiċi.
Posaconazole is a broad-spectrum triazole antifungal agent.
Posakonażol hija sustanza bi spectrum antifungali wiesgħa tal- klassi triazole..
The mechanism by which posaconazole exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase (CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi.
Il- mekkaniżmu li bih posakonażol jeżerċita l- azzjoni fungiċida jinvolvi l- inibizzjoni selettiva ta ’ l- enżima lanosterol 14 - demethylase (CYP51) involuta fil- bijosintesi ta ’ ergosterol fil- fungi u fil- fungi filamentużi.
In in vitro tests, posaconazole has shown fungicidal activity against most of the approximately 7,000 strains of yeast and filamentous fungi tested.
F’ testijiet in vitro, posakonażol wera attività fungiċidali kontra l- biċċa l- kbira tal- madwar 7, 000 razez ta ’ fungi u fungi filamentużi li ġew ittestjati.
Posaconazole is 40– 100 times more potent in vitro against Malassezia pachydermatis than clotrimazole, miconazole and nystatin.
Posakonażol hu 40– 100 darba iktar potenti in vitro kontra Malassezia pachydermatis minn klotrimażol, mikonażol u nistatin.
4/ 18 Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule’ s binding site.
4/ 18 enżimi li huma responsabbli għas- sit tat- twaħħil tal- molekula.
Cross-resistance across the fluoroquinolone class of antibiotics is common.
Reżistenza inkroċjata fil- klassi florokwinolon ta ’ antibijotiċi hi komuni.
Malassezia pachydermatis resistance to azoles, including posaconazole, has not been reported.
Ir- reżistenza ta ’ Malassezia pachydermatis għal azoles, li tinkludi posakonażol, ma kinitx irrappurtata.
The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis externa in an EU field trial conducted in 2000-2001 was:
L- attività in vitro ta ’ orbifloxaċin kontra patoġeni iżolati minn każijiet kliniċi ta ’ otie esterna fil- klieb fi provi ta ’ l- UE li saru fil- beraħ fl- 2000- 2001 kienet:
Minimum Inhibitory Concentrations vs.
Konċentrazzjonijiet Inibitorji Minimi vs.
Orbifloxacin – Summary
Orbifloxaċin – Sommarju
Pathogen E coli Enterococci Proteus mirabilis Pseudomonas aeruginosa Staphylococcus intermedius Streptococcus ß-haemolyticus G
Patoġenu E coli
6.2 Incompatibilities
Streptococcus ß- haemolyticus G
Not applicable.
2
6.3 Shelf life
4
Shelf-life after first opening the immediate packaging:
Sentejn Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ l- ippakjar immedjat:
Once opened do not store above 25 °C.
Ġaladarba jkun infetaħ, taħżinx f’ temperatura ta ’ ’ l fuq minn 25 °C.
Store in the original bottle and carton.
Aħżen fil- flixkun u fil- pakkett oriġinali.
6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ippakkjar immedjat
White opaque HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath.
Flixkun tal- HDPE abjad opak b’ għatu abjad tal- LDPE, applikatur ta ’ lewn naturali jew abjad LDPE u għant.
Bottle sizes:
Daqsijiet tal- flixkun:
8.8, 17.5 and 35.1 ml.
8. 8, 17. 5 and 35. 1 ml.
5/ 18 Not all pack sizes may be marketed.
5/ 18 Mhux id- daqsijiet kollha tal- pakkett jistgħu qegħdin fis- suq.
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 ta ’ prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Kull fdal tal- prodott mediċinali veterinarju li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott mediċinali veterinarju għandu jintrema kif jitolbu r- regolamenti lokali.
S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom
S- P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW Ir- Renju Unit
Detailed information on this veterinary medicinal 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- website ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
6/ 18 ANNEX II
6/ 18 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
S-P Bray Boghall Road County Wicklow Ireland
S- P Bray Boghall Road County Wicklow L- Irlanda
To be supplied only on veterinary prescription.
Sabiex jingħata biss bi preskrizzjoni veterinarja.
8/ 18 ANNEX III
8/ 18 ANNESS III
10/ 18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle containing 8.8, 17.5 or 35.1 ml.
Flixkun li fih 8. 8, 17. 5 jew 35. 1 ml.
Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
Posatex suspensjoni ta ’ qtar tal- widnejn 8. 5 mg ta ’ orbifloxaċin, 0. 9 mg ta ’ mometasone furoate (bħala monoħidrat) u 0. 9 mg posakonażol f’ kull ml għall- klieb.
8.5 mg/ ml orbifloxacin, 0.9 mg/ ml mometasone furoate (as monohydrate) and 0.9 mg/ ml posaconazole.
8. 5 mg/ ml ta ’ orbifloxaċin, 0. 9 mg/ ml ta ’ mometasone furoate (bħala monoħidrat) u 0. 9 mg/ ml ta ’ posakonażol.
Ear drops suspension.
Suspensjoni ta ’ qtar tal- widnejn.
8.8 ml 17.5 ml 35.1 ml
SPEĊI GĦAL XIEX HUWA INDIKAT IL- PRODOTT
5.
Klieb
Treatment of acute external otitis, and acute exacerbations of recurrent external otitis.
Kura ta ’ otite esterna akuta, u aggravamenti akuti ta ’ otite esterna rikorrenti.
For auricular use only.
Għal użi fil- widnejn biss.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel l- użu.
EXP {2 digits / year} Once opened use within 28 days.
JIS {2 numri / sena} La darba jinfetaħ uża fi żmien 28 jum.
Store in a refrigerator Once opened do not store above 25º C.
Aħżen fi friġġ Ġaladarba jkun infetaħ, taħżinx f’ temperatura ta ’ ’ l fuq minn 25o C.
Dispose of waste material in accordance with local requirements.
Armi l- iskart skond kif jitolbu r- regolamenti lokali.
12/ 18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
Posatex suspensjoni ta ’ qtar tal- widnejn 8. 5 mg ta ’ orbifloxaċin, 0. 9 mg ta ’ mometasone furoate (bħala monoħidrat) u 0. 9 mg posakonazol f’ kull ml għall- klieb.
8.5 mg/ ml orbifloxacin, 0.9 mg/ ml mometasone furoate (as monohydrate) and 0.9 mg/ ml posaconazole.
8. 5 mg/ ml ta ’ orbifloxacin, 0. 9 mg/ ml ta ’ mometasone furoate (bħala monohydrate) u 0. 9 mg/ ml ta ’ posaconazole.
For auricular use only.
ŻMIEN TA ’ TIŻMIM
EXP {2 digits/ year} Once opened use within 28 days.
JIS {2 numri / sena} La darba jinfetaħ uża fi żmien 28 jum.
14/ 18 PACKAGE LEAFLET Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
14/ 18 FULJETT TA ’ TAGĦRIF Posatex suspensjoni ta ’ qtar tal- widnejn 8. 5 mg ta ’ orbifloxacin, 0. 9 mg ta ’ mometasone furoate (bħala monohydrate) u 0. 9 mg posaconazole kull ml għall- klieb.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Marketing authorisation holder
Sid l- Awtorizzazzjoni għall- Kummerċ
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Kura ta ’ otite esterna akuta u aggravamenti akuti ta ’ otite esterna rikorrenti, assoċjata ma ’ batterja suxxettibbli għal orbifloxaċin u fungi suxxettibbli għal posakonażol, b’ mod partikulari Malassezia pachydermatis.
Do not use if the eardrum is perforated.
Tużax jekk it- tanbur tal- widna jkun imtaqqab.
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents and to other fluoroquinolones.
Tużax f’ każ ta ’ sensittività eċċessiva għal xi waħda mis- sustanzi tal- prodott mediċinali veterinarju, għall- kortikosterojdi, għal sustanzi antifungali azole oħrajn u florokwinolons oħra.
TARGET SPECIES
Klieb
Auricular use.
Biex jingħata ġol- widnejn.
One drop contains 244 µg orbifloxacin, 24 µg mometasone furoate and 24 µg posaconazole.
Qatra waħda fiha 244 µg ta ’ orbifloxaċin, 24 µg ta ’ mometasone furoate u 24 µg ta ’ posakonażol.
With dogs weighing under 2 kg, apply 2 drops to the ear once a day.
Għal klieb li jiżnu inqas minn 2 kg: applika 2 qatriet ġol- widna darba kuljum.
With dogs weighing 2-15 kg, apply 4 drops to the ear once a day.
Għal klieb li jiżnu 2- 15 kg: applika 4 qatriet ġol- widna darba kuljum.
With dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Għal klieb li jiżnu 15 kg jew iżjed: applika 8 qatriet ġol- widna darba kuljum.
The external ear canal should be meticulously cleaned and dried before treatment.
Il- kanal estern tal- widna għandu jitnaddaf bir- reqqa u jitnixxef qabel il- kura.
Excess hair around the treatment area should be cut.
Ix- xagħar eċċessiv madwar iż- żona li tkun ser tiġi kkurata għandu jinqata ’.
Shake the bottle thoroughly before administration
Ħawwad il- flixkun tajjeb qabel ma tamministra.
Once opened do not store above 25 ºC.
Ġaladarba jkun infetaħ, taħżinx f’ temperatura ta ’ ’ l fuq minn 25o C.
Do not use after the expiry date, which is stated on the label.
Tużax wara d- data ta ’ skadenza li jkun hemm fuq it- tikketta.
Shelf-life after first opening the bottle:
Iż- żmien kemm idum tajjeb wara li l- flixkun jinfetaħ għall- ewwel darba:
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Otite batterjali u fungali ta ’ spiss tkun sekondarja fin- natura tagħha, u għandha ssir dijanjosi adattata biex tistabbilixxi l- fatturi primarji involuti.
These measures should help to protect the environment.
Dawn il - miżuri għandhom jgħinu sabiex tipproteġi l- ambjent.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. UE
What is Poulvac FluFend H5N3 RG?
X’ inhu Poulvac FluFend H5N3 RG?
Poulvac FluFend H5N3 RG is a vaccine containing an inactivated avian influenza virus H5N3 (inactivated means that the virus has been killed so that it cannot cause the disease anymore).
Poulvac FluFend H5N3 RG huwa vaċċin li fih il- vajrus avjarju inattivat tal- influwenza H5N3 (inattivat jiġifieri li l- vajrus inqatel sabiex ma jkunx jista ’ jikkawża l- marda).
What is Poulvac FluFend H5N3 RG used for?
Għal xiex jintuża Poulvac FluFend H5N3 RG?
Poulvac FluFend H5N3 RG is a vaccine used in chickens and ducks to protect against avian influenza.
Poulvac FluFend H5N3 RG huwa vaċċin użat fit- tiġieġ u l- papri 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 tal- eskrezzjoni (twaqqigħ tar- rix) tal - vajrus mit- tjur infettat.
The vaccine is injected intramuscularly (into the breast muscle) in chickens or subcutaneously (under the skin) in ducks, as two doses, 3 weeks apart.
Il- vaċċin jiġi injettat fil- muskolu (fil- muskolu tas- sider) fit- tiġieġ jew fil- ġilda fil- papri, f’ żewġ dożi b’ intervall ta ’ tliet ġimgħat bejniethom.
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 approvat għall- kontroll tal- 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 huwa r- responsabbiltà ta ’ l- awtoritajiet veterinarji nazzjonali f’ konsultazzjoni mal- Kummissjoni Ewropea.
How does Poulvac FluFend H5N3 RG work?
Kif jaħdem Poulvac FluFend H5N3 RG?
Poulvac FluFend H5N3 RG is a vaccine.
Poulvac FluFend H5N3 RG huwa vaċċin.
When it is given to birds, the animals’ immune systems (their natural defences) learn how to make antibodies (a special type of protein) to fight the virus.
Meta jingħata lit- tjur, is- sistema immunitarja tagħhom (id - difiża naturali tagħhom) tibda tipproduċi antikorpi (tip speċjali ta ’ proteina) sabiex tiġġieled il- mard.
In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease.
Fil- futur, jekk it- tjur huma esposti għall- vajrus ta ’ l- influwenza avjarja, is- sistema immunitarja tagħhom tkun kapaċi tipproduċi antikorpi b’ ritmu aktar mgħaġġel u dan jgħinhom jiġġieldu l- marda.
The virus used for the vaccine is a recombinant virus.
Il- vajrus li jintuża għall- vaċċin huwa wieħed rikombinanti.
It has been made using a ‘ recombinant DNA technique’ (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens.
Sar bl- użu ta ’ ‘ teknika ta ’ DNA rikombinanti ’ (meta ġeni jiddaħħlu f’ organiżmu) biex ikollu l- antiġeni H5 (emagglutinina 5) u N3 (newraminidażi 3).
This kind of ‘ reassortment ’ between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties.
Dan it- tip ta ’ ‘ assortiment mill- ġdid ’ bejn it- tipi H u N isir naturalment iżda f’ dan il- każ għandu jitwettaq f’ laboratorju biex jipproduċi vajrus b’ dawn il- karatteristiċi speċifiċi ħafna.
Birds vaccinated with this vaccine make antibodies against these two chosen antigens.
It - tjur li jingħataw dan il- vaċċin jipproduċu antikorpi kontra dawn iż- żewġ antiġeni.
This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Din l- istrain intgħażlet minħabba li tipproteġi t- tjur kontra d- damma tal- istrain H5N1 virulenti (cross protection), filwaqt li tippermetti d- differenzjazzjoni bejn tjur ta ’ vaċċinati u tjur infettati.
Vaccinated birds can be differentiated from infected birds by looking for antibodies against the N3 component.
It- tjur vaċċinati jistgħu jintgħarfu mit- tjur infettati mill- preżenza ta ’ antikorpi kontra l- kompost N3.
This differentiation is important for disease surveillance and control.
Din id- differenzjazzjoni hija importanti għas- sorveljanza u l- kontroll tal- mard.
How has Poulvac FluFend H5N3 RG been studied?
Kif ġie studjat Poulvac FluFend H5N3 RG?
• In chickens:
• Fit- tiġieġ:
Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen.
Twettqu studji fil- laboratorju li eżaminaw is- sigurtà tal- vaċċin wara doża waħda, wara doża eċċessiva u f’ reġimwara sistema ta ’ dożaġġ ripetut.
The results of studies of a similar vaccine on chickens free of any infection (containing the same ingredients, except for the virus) were also looked at.
Ġew eżaminati wkoll ir- riżultati tal- istudji ta ’ vaċċin simili fuq it- tiġieġ li ma kinux infettati (li kien fih l- istess sustanzi ħlief il- vajrus).
A field trial was also carried out.
Twettqet ukoll prova fil- post.
• In ducks:
• Fil- papri:
Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen.
Twettqu studji fil- laboratorju li eżaminaw is- sigurtà tal- vaċċin wara doża waħda, wara doża eċċessiva u f’ reġim ta ’ dożaġġ ripetut.
No field trial is available for this target species.
M’ hemm l- ebda prova fil- post disponibbli għall- ispeċi fil- mira.
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian influenza.
Dan huwa aċċettabbli minħabba s- sitwazzjoni politika u epidemjoloġika ta ’ l- Ewropa fir- rigward ta ’ l- influwenza avjarja.
The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed.
Il- vaċċin kien valutat fil- kuntest ta ’ sitwazzjoni ta ’ emerġenza li jfisser li għadhom għaddejin studji fuq Poulvac FluFend H5N3 RG u dawn ser jiġu valutati.
What benefit has Poulvac FluFend H5N3 RG shown during the studies? • The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks. • If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.
• L- istudji wrew li t- tjur li ngħataw il- vaċċin żviluppaw antikorpi kontra s- sottotip H5 tal- vajrus tal - influwenza avjarja. • Il- vaċċin wera li jnaqqas is- sinjali kliniċi u l- mortalità u jnaqqas it- tixrid tal- vajrus f’ tiġieġ u papri infettati. • Jekk il- vajrus ta ’ l- influwenza avjarja li jinxtered għandu komponent N differenti mill- N3 li jinsab fil- vaċċin, jista ’ jkun possibbli li wieħed jagħmel differenza bejn tjur li ngħataw il- vaċċin u dawk infettati permezz ta ’ test dijanjostiku sabiex jinsabu antikorpi newraminidażi speċifiċi.
What is the risk associated with Poulvac FluFend H5N3 RG?
X’ inhu r- riskju assoċjat ma ’ Poulvac FluFend H5N3 RG?
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 aġġuvanti tista ’ titla ’ nefħa fil- post fejn jingħata l- vaċċin li tista ’ ddum għal 14- il jum.
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 l - awtoinjezzjoni aċċidentali.
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 mill- bniedem (perjodu ta ’ rtirar)?
Zero days The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.
L- ebda ġurnata Il- vaċċin ma fihx sustanzi li jistgħu jkunu ta ’ riskju għall- konsumaturi ta ’ tjur vaċċinati.
Why has Poulvac FluFend H5N3 RG been approved?
Għaliex ġie approvat Poulvac FluFend H5N3 RG?
The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be safe and to be effective in preventing disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Il- Kumitat għall- Użu ta ’ Prodotti Mediċinali għall- Użu Veterinarju kkonkluda li l- vaċċin wera li huwa sikur u effikaċi fit- tnaqqis ta ’ mard fit- tjur u jista ’ jkun għodda utli fil- kontroll ta ’ tifqigħa 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 t- theddid sussegwenti kemm għas- saħħa tal- bniedem kif ukoll ta ’ l- annimal, il- Kumitat jirrakkomanda l- għoti ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Page 2/ 3 ©EMEA 2008 Poulvac FluFend H5N3 RG has been authorised under “ Exceptional Circumstances”.
2/ 3 ©EMEA 2008 Poulvac FluFend H5N3 RG ġie awtorizzat taħt “ Ċirkostanzi Eċċezzjonali ”.
This means that it has yet not been possible to obtain complete information about Poulvac FluFend H5N3 RG.
Dan ifisser li għadu ma kienx possibbli li jinkiseb it- tagħrif kollu dwar Poulvac FluFend H5N3 RG.
Other information about Poulvac FluFend H5N3 RG:
Tagħrif ieħor dwar Poulvac FluFend H5N3 RG:
The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG to Fort Dodge Animal Health on 01.09.2006.
01. 09. 2006.
This summary was last updated on 31.07.2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Invented name
kummerċjali
Strength
Qawwa Għamla
Pharmaceutical Form
Farmaċewtika
Target species
Speċi li fuqhom
Route of administration
għandu jintuża
Packaging
l- prodott
Content
Mod ta ’
Package size
Amministraz zjoni
Withdrawal Period
Ippakkjar Kontenut Daqs talpakkett
> 1:40 HI Emulsion for units per injection dose
40 HI
Chickens and ducks
emulsjoni għal injezzjoni
Intramuscular or subcutaneous
Tiġieġ u papri
High-density polyethylene bottles with rubber stopper and aluminium cap
Għal użu taħt Fliexken tal - ilġilda
500 ml
500 ml 1
Zero days
Junits
> 1:40 HI Emulsion for units per injection dose
40 HI Junits
High-density polyethylene bottles with rubber stopper and aluminium cap
Għal użu taħt Fliexken tal - ilġilda polyethylene ta ’ jew filmuskolu. densità għolja, magħluqin f’ tapp tal- lastku nitrile u b’ għatu ta ’ l - aluminju.
10 bottles
10 Flixkun
Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Poulvac FluFend H5N3 RG emulsjoni għall- injezzjoni għat- tiġieġ u Papri.
One dose of 0.5 ml contains:
Doża waħda ta ’ 0. 5 ml fiha:
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04) > 1:40 HI units per dose
40 HI units
Adjuvants:
Aġġuvanti:
White Oil Sorbitan sesquioleate Polysorbate 80
Żejt abjad Sorbitan sesquioleate Polysorbate 80
Thiomersal Phosphate Buffer Saline
Thiomersal Phosphate Buffer Saline
For a full list of excipients, see section 6.1.
Għal lista sħiħa ta ’ sustanzi mhux attivi, ara section 6. 1.
Emulsion for injection.
Emulsjoni għall- injezzjoni.
Chickens and ducks.
Tiġieġ u papri.
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Għall- immuniżżazzjoni attiva ta ’ tiġieġ u papri kontra l- virus ta ’ l- influwenza avjana tip A, sottotip H5
Chickens:
Tiġieġ:
Reduction of mortality and virus excretion after challenge.
Tnaqqis fil- mortalità u eskrezzjoni tal- virus wara sfida immunloġika bil- prodott.
Onset of immunity:
Bidu ta ’ immunità:
3 weeks after the second injection.
3 ġimgħat wara t- tieni injezzjoni.
Duration of immunity in chickens has not been established yet.
It- tul ta ’ l- immunità fil- flieles għada ma ġietx stabbilita.
Ducks:
Papri:
Reduction of clinical signs and virus excretion after challenge.
Tnaqqis ta ’ sinjali kliniċi u eskrezzjoni tal- virus wara sfida immunloġika bil- prodott.
Duration of immunity in ducks:
It- tul ta ’ l- immunità fil- papri:
14 weeks after the second injection.
14- il ġimgħa wara t- tieni njezzjoni.
2 4.4 Special warnings for each target species
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott
No information is available on the interference of maternally derived antibodies on vaccination for both target species.
Il- livell ta ’ effikaċja miksub jista ’ jvarja skond il- grad ta ’ omoloġija antiġenika bejn ir- razza tal- vaċċin u razzez li qed jiċċirkulaw fl- ambjent 2 Ma hemm l- ebda informazzjoni dwar l- interferenza ta ’ antikorpi mnisslin mill- omm fuq il - vaċċinazzjoni, għaż- żewġ speċi li fuqhom jintuża l- prodott.
Avoid stress in the birds around the time of vaccination.
Evita stress fit- tjur fiż- żmien tal- vaċċinazzjoni.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew fuqek innifsek tista ’ tirriżulta f’ uġigħ qawwi u nefħa, partikolarment jekk tiġi injettata f’ ġog jew f’ saba ’., F’ każijiet rari tista ’ tirriżulta fit- telf tas- saba ’ effettwat jekk ma tingħatax attenzjoni medika fil- pront.
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 aċċidentalment tkun injettat b’ dan il- prodott, fittex parir mediku fil- pront anke jekk l- ammont injettat ikun żgħir ħafna, u ħu l- fuljett tat- tagħrif miegħek.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ jippersisti għal aktar minn 12- il siegħa wara l- eżami mediku, erġa ’ fittex parir mediku.
To the physician:
Għat- tabib:
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni aċċidentali b’ dan il- prodott tista ’ tikkaġuna nefħa qawwija, li tista ’, per eżempju, tirriżulta f’ nekrożi iskemika u anke telf ta ’ saba ’.
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 kiruġika, esperta, u FIL- PRONT, hi meħtieġa li tista ’ tinkludi inċiżjoni u irrigazzjoni bikrija tal- parti injettata, speċjalment jekk ikun hemm involviment tal- laħam tas- saba ’ jew l- għerq.
A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines.
Reazzjoni lokali fis- sit ta ’ l- injezzjoni (nefħa) li tgħaddi maż- żmien, tista ’ kultant iseħħ kif inhu normali b’ vaċċini miżjuda biż- żejt.
No information is available on the safety of this vaccine for birds in lay.
Ma hemm l- ebda informazzjoni dwar is- sigurtà ta ’ dan il- vaċċin fi tjur li jkun se jbid.
No information is available on the compatibility of this vaccine with any other.
L- ebda tagħrif ma huwa disponibbli dwar il- kompatibilità ta ’ dan il- vaċċin ma ’ oħrajn.
Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Għalhekk is - sigurtà u l- effikaċja ta ’ dan il- prodott meta wżat flimkien ma ’ xi prodott ieħor (fl- istess ġurnata jew f’ waqtiet differenti) ma ġewx dimostrati.
Chickens 3 weeks of age or older:
Tiġieġ Età ta ’ 3 ġimgħat jew akbar:
0.5 ml intramuscularly in the breast muscle.
0. 5 ml intramuskolari fil- muskolu tas- sider.
Revaccinate after 3 weeks.
Laqqam mill- ġdid wara 3 ġimgħat.
The vaccination schedule should be completed at least 4 weeks before the start of laying.
L- iskeda tat- tilqim għandha tkun kompluta ta ’ l- anqas 4 ġimgħat qabel ma ’ jibdew ibidu.
Ducks At one day old:
Papri F’ età ta ’ jum wieħed:
0.2 ml subcutaneously in the neck.
0. 2 ml taħt il- ġilda fl- għonq.
Revaccinate after 3 weeks:
Laqqam mill- ġdid wara 3 ġimgħat:
0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
L- iskeda tat- tilqim għandha tkun kompluta ta ’ l- anqas 4 ġimgħat qabel ma ’ jibdew ibidu.
Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed.
3 Wara l- amministrazzjoni ta ’ doża doppja fit- tiġieġ u l- papri, l- ebda reazzjonijiet avversi għajr dawk deskritti f’ sezzjoni 4. 6 ma ġew osservati.
Inactivated recombinant vaccine, ATC vet code:
Vaċċin rikombinanti inattivat, Kodiċi ATĊ veterinarja:
To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype.
Biex tistimula l- immunità attiva fit- tiġieġ u l- papri kontra l- virus ta ’ l- influenza avjana, sottotip H5.
To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Biex tinduċi reazzjoni seroloġika kontra N3 neuraminidase li jistà jservi bħala marker biex Tagħraf Annimali Infettati minn Dawk Imlaqqma (strateġija DIVA).
6.1 List of excipients
6. 1 Lista ta ’ sustanzi
White Oil Sorbitan sesquioleate Polysorbate 80 Thiomersal Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic
Żejt abjad Sorbitan sesquioleate Polysorbate 80 Thiomersal Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic
Do not mix with any other medicinal product.
Tħallatx ma ’ prodotti mediċinali oħra.
The entire content of the bottle should be used within 2 hours after broaching the container.
Il- kontenut kollu tal- flixkun għandu jintuża fi żmien sagħtejn wara li jittaqqab il- kontenitur.
Store and transport refrigerated (2° to 8°C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Store in the original container in order to protect from light.
Aħżen fil- kontenitur oriġinali sabiex ikun protett mid- dawl.
500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
500 ml ta ’ vaċċin fi fliexken tal- polyethylene ta ’ densità għolja, magħluqin f’ tapp tal- lastku nitrile u b’ għatu ta ’ l- aluminju.
The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
Il- vaċċin jiġi f’ kaxxi ta ’ flixkun wieħed jew 10 ta ’ 500 ml.
4 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste material derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użat jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal ieħor għar- rimi mnissel minn prodotti mediċinali veterinarji għandu jintrema skond kif titlob il- liġi tal- pajjiż.
1 September 2006
JJ/ XX/ SSSS
The import, sale, supply and/ or use of Poulvac FluFend H5N3 RG is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU L- importazzjoni, il- bejgħ, il- provvista u/ jew l- użu ta ’ Poulvac FluFend H5N3 RG huma pprojbiti jew jistgħu jkunu pprojbiti f’ ċertu Stati Membri jew ġo parti mit- territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa ta ’ l- annimali.
Any person intending to import, sell, supply and/ or use Poulvac FluFend H5N3 RG 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 bi ħsiebha timporta, tbiegħ, tipprovdi u/ jew tuża Poulvac FluFend H5N3 RG għandha tikkonsulta l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta ’ tilqim kurrenti qabel l- importazzjoni, bejġh, provista u/ jew użu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Fort Dodge Animal Health Holland CJ van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland CJ van Houtenlaan 36 1381 CP Weesp L- Olanda
Fort Dodge Animal Health (Charles City) 2000 Rockford Road Charles City, Iowa 50616 USA
Fort Dodge Animal Health (Charles City) 2000 Rockford Road Charles City, Iowa 50616 L- Istati Uniti
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott
According to Article 71 of Directive 2001/ 82/ EC 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 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 > b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
a) l- amministrazzjoni tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l - implimentazzjoni ta ’ programmi nazzjonali għad- dijanjosi, 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 miġjuba 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 veterinarju mediċinali huwa permess biss taħt il- kundizzjonijiet partikolari stabbiliti mill- leġiżlazzjoni tal- Komunità Ewropea fuq il- kontroll ta ’ l- Influwenza Avjana.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtoriżżazzjoni tal- kummerċ għandu jinforma lil Kummissjoni Ewropeja dwar il- pjanijiet ta ’ kummerċjaliżżazzjoni għall- prodott mediċinali awtoriżżat b’ din id- deċiżjoni.
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
L- isem tas- sustanza( i) attiva( i), {INN}} huwa/ huma inklużi fl- Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li ġejja:
Pharmacologically active substance Mineral oils Arlacel 83V (sorbitan sesquioleate) Tween 80 (polyoxyethylene sorbitan monooleate)
Żjut minerali Arlacel 83V (sorbitan sesquioleate) Tween 80 (polyoxyethylene sorbitan monooleate)
Animal Species All food producing species All food producing species All food producing species
L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel
Other provisions
L- ispeċi kollha li jipproduċu l- ikel
Sodium chloride Sodium phosphate dibasic (E339) Potassium phosphate monobasic (E340)
Potassium phosphate monobasic (E340)
All food producing species All food producing species All food producing species
L- ispeċi kollha li jipproduċu l- ikel
All food producing species
L- ispeċi kollha li jipproduċu l- ikel
For use only as preservatives in multidose vaccines at a concentration not exceeding 0.02%(concentration in the product is 0.004%)
Sabiex jintuża biss bħala preservattiv f’ vaċċini ta ’ aktar minn doża wahda f’ konċentrazzjoni li ma taqbiżx 0. 02% (il- konċentrazzjoni fil- prodott hi 0. 004%)
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TA 'SID L- AWTORIZZAZZJONI TAL- KUMMERĊ
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 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima annwali tal- profil tal - benefiċċju/ riskju.
More detailed information on the specific obligations is set out in the CVMP assessment report.
Informazzjoni aktar dettaljata dwar l- obligazzjonijiet speċifiċi tinstab fir- rapport ta ’ stima tas- CVMP.
QUALITY ASPECTS
ASPETTI FUQ IL- KWALITÀ
1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used), the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too) and the lack of any stability data.
1) Hemm kwistjonijiet importanti li għadhom ma ġewx solvuti dwar id- differenzi fuq il- produzzjoni u l- kontroll bejn is- siti ta ’ produzzjoni (li jinkludu n- natura tal- bajd użati), in- nuqqas ta ’ studju dwar il- validita ’ fuq it- test tal- qawwa tal- prodott finali (jidher li t- testijiet tal- prodott finali jsiru biss f’ Weesp imma testijiet matul il- proċess bħal titrazzjoni u kwantifikazzjoni HA jeħtieġ li jkunu ekwivalenti wkoll) u n- nuqqas dwar xi data fuq l- istabbilità.
With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested.
Fir- rigward id- differenzi fil- produzzjoni u l- kontroll, l- armonizzazzjoni tal - proċess ta ’ produzzjoni u l- kontrolli bejn iż- żewġ siti ta ’ produzzjoni huwa rakkomandat b’ mod qawwi.
An alternative solution could be to retain only one production site.
Soluzzjoni alternattiva taf tkun li jinżamm sit wieħed biss ta ’ produzzjoni.
In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study).
B’ mod partikolari, razzjonalizzazzjoni tan- natura tal- bajd użat (li jieħu in konsiderazzjoni il - problema tal- preżenza possibbli ta ’ aġenti barranin f’ bajd konvenzjonali u l- possibilità li dawn jiġu inattivati matul il- proċess ta ’ inattivazzjoni tal- virus ta ’ l- influwenza, li hu appoġġjat minn studju ta ’ validita ’ korrispondenti).
The Applicant is asked to commit to take appropriate measures to harmonise the productions and/ or to provide the adequate demonstrations/ data to solve the issues.
L- Applikant hu mitlub li jikkommetti ruħu biex jieħu miżuri xierqa sabiex jarmonizza l- produzzjonijiet u/ jew jipprovdi l- mezzi/ data adegwata biex isolvi dawn il - kwistjonijiet.
2) The Applicant should commit to generate stability data for the shelf life to be established.
2) L- Applikant għandu jimpenja ruħu li jiġġenera tagħrif dwar stabilità sabiex jiġi stabbilit kemm idum tajjeb il- prodott.
8 ANNEX III
8 ASPETTI TA ’ FARMAKOVIĠILANZA
LABELLING AND PACKAGE LEAFLET
3) L- Applikant hu meħtieġ li jissottometti rapporti ta ’ Aġġornament dwar is- Sigurtà kull 3 xhur għall- ewwel sentejn wara l- użu iniżjali fil- kamp u hu addizzjonalment meħtieġ li jippreżenta protokoll li jiżgura irrekordjar u raportaġġ ta ’ data tal- kamp fir- rigward ta ’ reazzjonijiet avversi suspettati li jinkludi nuqqas suspettat ta ’ effikaċja.
LABELLING
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL
TIKKETTA
Poulvac FluFend H5N3 RG Emulsion for injection
Poulvac FluFend H5N3 RG Emulsjoni għall- injezzjoni
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)
Virus rikombinat inattivat ta ’ l- influwenza avjana ta ’ sottotip H5N3 (strejn rg- A/ ck/ VN/ C58/ 04) > 1:
> 1:40 HI Units
40 HI Junits
Water in oil adjuvant
Aġuvant ta ’ ilma fiż- żejt
Emulsion for injection
Emulsjoni għall- injezzjoni
Chickens and ducks
Tiġieġ u papri
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Għal imuniżżazzjoni attiva ta ’ tiġieġ u papri kontra l- virus ta ’ l- influwenza avjana ta ’ tip A, sottotip H5.
Reduction of mortality and virus excretion after challenge.
Tnaqqis fil- mortalità u eskrezzjoni tal- virus wara sfida immunoloġika bil- prodott.
Reduction of clinical signs and virus excretion after challenge.
Tnaqqis tas- sinjali kliniċi u eskrezzjoni tal- virus wara sfida immunoloġika bil- prodott.
14 weeks after the second injection.
14- il ġimgħa wara t- tieni njezzjoni
METHOD AND ROUTES OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
Chickens 3 weeks of age or older:
Tiġieġ Minn età ta ’ 3 ġimgħat jew aktar:
The vaccination schedule should be completed at least 4 weeks before the start of laying.
L- iskeda tat- tilqim għandha tkun lesta ta ’ l- anqas 4 ġimgħat qabel ma jibdew ibidu.
Revaccinate after 3 weeks:
Erġa ’ laqqam wara 3 ġimgħat:
0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
L- iskeda tat- tilqim għandha tkun kompluta ta ’ lanqas 4 ġimgħat qabel ma 'jibdew ibidu.
Read the package leaflet before use
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża
Withdrawal period - Zero days
Żmien ta ’ tiżmin – xejn ġranet
Accidental injection is dangerous.
Injezzjoni aċċidentali hi perikoluża.
EXP (month/ year)
JISKADI (xahar/ sena)
Once broached, use within 2 hours.
Wara li jitaqqab il- kontenitur, uża fi żmien sagħtejn.
Store and transport refrigerated (2° to 8°C).
Aħżen u ttrasporta ġo friġġ (2° sa 8°C).
Store in the original container in order to protect from light.
Aħżen fil- kontenitur oriġinali sabiex tipproteġi mid- dawl.
THE WORDS ‘ FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF 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
For animal treatment only
Għal trattament ta ’ l- annimali biss
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 biss taħt il- kondizzjonijiet partikolari stabbiliti mill- leġiżlazzjoni tal- Komunità Ewropea fuq il- kontroll ta ’ Influwenza Avjana.
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton UK SO30 4QH
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH Ir- Renju Unit
Lot (Number)
Lott (Numru)
13 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR TIKKETTA TAL- FLIXKUN
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)) > 1:40 HI Units
40 HI Units
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Għal imuniżżazzjoni attiva ta ’ tiġieġ u papri kontra l- virus ta ’ l- influwenza avjana ta ’ tip A, sottotip H5
Chickens 3 weeks of age or older:
15 Età ta ’ 3 ġimgħat jew aktar:
The vaccination schedule should be completed at least 4 weeks before the start of laying.
L- iskeda tat- tilqim għandha tkun kompluta ta ’ l- anqas 4 ġimgħat qabel ma jibdew ibidu.
0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
0. 5 ml taħt il- ġilda fl- għonq L- iskeda tat- tilqim għandha tkun kompluta ta ’ l- anqas 4 ġimgħat qabel ma jibdew ibidu.
Once broached, use within 2 hours.
Wara li jitaqqab il- kontenitur, għandu jintuża fi żmien sagħtejn.
Store and transport refrigerated (2ºC - 8ºC).
Aħżen u ttrasporta ġo friġġ (2° sa 8°C).
Keep in the original container in order to protect from light.
Aħżen fil- kontenitur oriġinali sabiex tipproteġi mid- dawl.
For disposal read the package leaflet.
Għar- rimi aqra l- fuljett tat- tagħrif.
THE WORDS ‘ FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF 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
THE WORDS ‘ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN’
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton UK SO30 4QH
Fort Dodge Animal Health Ltd Flanders Road, Hedge End
MANUFACTURER’ S BATCH NUMBER
16 Southampton Ir- Renju Unit SO30 4QH
17 PACKAGE LEAFLET FOR:
NUMRU TAL- LOTT TAL- MANIFATTUR
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton UK SO30 4QH
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton Ir- Renju Unit SO30 4QH
Fort Dodge Animal Health Holland
Fort Dodge Animal Health l- Olanda
Poulvac FluFend H5N3 RG Emulsion of injection
Poulvac FluFend H5N3 RG Emulsjoni għall- injezzjoni
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)
40 HI units tas- sottotip H5N3 (strejn rg- A/ ck/ VN/ C58/ 04
Reduction of mortality and virus excretion after challenge.
Tnaqqis ta ’ mortalità u eskrezzjoni tal- virus wara sfida immunoloġika bil- prodott.
Reduction of clinical signs and virus excretion after challenge.
Tnaqqis ta ’ sinjali kliniċi u eskrezzjoni ta ’ virus wara sfida immunoloġika bil- prodott.
If you notice any serious 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.
Do not mix with any other medicinal product.
Tħallatx ma ’ prodotti mediċinali veterinarji oħra.
Withdrawal period:
Perjodu ta ’ tiżmin:
Store and transport refrigerated (2ºC - 8ºC).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Keep in the original container in order to protect from light.
Aħżen fil- kontenitur oriġinali sabiex ikun protett mid- dawl.
The entire content of the bottle should be used within 2 hours after broaching the container.
Il- kontenut kollu tal- kontenitur għandu jintuża fi żmien sagħtejn wara li jittaqqab il- kontenitur.
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 miksub jista ’ jvarja skond il- grad ta ’ omoloġija antiġenika bejn ir- razza tal - vaċċin u razzez li qed jiċċirkulaw fl- ambjent
For animal treatment only
Għal trattament ta ’ l- annimali biss.
19 To the user This product contains mineral oil.
20 Għal min ser juża Dan il- prodott fih żejt minerali.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew fuqek innifsek tista ’ tirriżulta f’ uġigħ qawwi u nefħa, partikolarment jekk tiġi injettata f’ ġog jew f’ saba ’.
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.
F’ każijiet rari tista ’ tirriżulta fit- telf tas- saba ’ effettwat jekk ma tingħatax attenzjoni medika fil- pront.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk aċċidentalment tkun injettat b’ dan il- prodott, fittex parir mediku fil- pront anke jekk l- ammont injettat ikun żgħir ħafna, u ħu l- fuljett tat- tagħrif miegħek.