qanastek/EMEA-V3 huggingface dataset:
The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs.
L- istudji saru skond il- ħtiġijiet addattati tal- monografi tal- Farmakopea Ewropea.
Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the SPC.
Filwaqt li x’ aktarx li l- vaċċin ma jaffettwax il- fertilità tar- raġel, madankollu ġiet inkluża twissija fis - SKP.
The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated.
Is- sigurtà ntweriet ukoll għal speċi ta ’ għasafar mhux suxxettibbli (faġani, papri, perniċi, summien u ħamiem) u għal speċi ta ’ mammiferi (ġrieden u fniek ta ’ l- Indi).
As for any turkey Herpesvirus (HVT) live vaccine, the product is excreted from vaccinated birds and may spread to turkeys.
Il- prodott huwa eliminat mill- għasafar imlaqqma, bħal fi kwalunkwe vaċċin ħaj tal- Herpesvirus tad- dundjani (HVT) u li jista ’ jinfirex għad - dundjani.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Vaxxitek HVT+IBD shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċju wera Vaxxitek HVT+IBD waqt l- istudji?
The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against Infectious Bursal disease.
L- istudji urew li Vaxxitek HVT+IBD huwa effettiv fit- tilqim attiv tat- tiġieġ u flieles fil- bajda kontra l - Marda Burżali Infettiva.
The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks.
Il- bidu tal- protezzjoni huwa minn ġimagħtejn ’ l hemm u l- protezzjoni testendi sa 9 ġimgħat.
The vaccine is also effective against Marek’ s disease.
Il- vaċċin huwa effettiv ukoll kontra l- marda ta ’ Marek.
The onset of protection is from 4 days onwards.
Il- bidu tal- protezzjoni huwa minn 4 ijiem ’ l hemm.
A single vaccination is sufficient to provide protection during the risk period.
Tilqima waħda hija biżżejjed biex tipprovdi protezzjoni waqt il- perijodu ta ’ riskju.
What is the risk associated with Vaxxitek HVT+IBD?
X’ inhu r- riskju assoċjat ma ’ Vaxxitek HVT+IBD?
Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds.
Għasafar b’ saħħithom biss għandhom jitlaqqmu u l- prodott m’ għandux jintuża f’ għasafar li jkunu qed ibidu jew inisslu.
No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’ s disease, Newcastle disease and Infectious bronchitis.
Ma hemm l- ebda tagħrif fuq is- sigurtà u l- effikaċja mill- użu fl- istess ħin ma ’ kwalunkwe vaċċin ieħor, ħlief vaċċini attenuwati Merial kontra l- marda ta ’ Marek, marda Newcastle u bronkite infettiva.
It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Huwa għaldaqstant irrikmandat li l- ebda vaċċin ieħor m’ għandu jiġi amministrat fi żmien 14- il jum wara tilqima bil- prodott.
In the absence of specific studies, no other vaccine should be administered at the same time when the product is injected into eggs.
Fin - nuqqas ta ’ studji speċifiċi, l- ebda vaċċin ieħor m’ għandu jiġi amministrat fl- istess ħin li l- prodott ikun injettat ġol- bajd.
As the product is stored in a tank under liquid nitrogen, particular instructions for reconstitution of the vaccine are provided in the product information module of the EPAR.
Minħabba li l- prodott huwa maħżun f’ tank taħt nitroġenu likwidu, huma ipprovduti struzzjonijiet partikolari għar- rikostituzzjoni tal- vaċċin fil- modulu tat- tagħrif fuq il- prodott ta ’ l- EPAR.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
X’ inhu ż- żmien li għandu jitħalla qabel l- annimal jista ’ jinqatel u l- laħam jintuża għall- konsum mill- bniedem (perijodu ta ’ irtirar)?
Why has Vaxxitek HVT+IBD been approved?
Għal x’ hiex ġie approvat Vaxxitek HVT+IBD?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vaxxitek HVT+IBD exceed the risks of its use in chickens and recommended that Vaxxitek HVT+IBD be given a marketing authorisation.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Vaxxitek HVT+IBD jaqbżu r- riskji ta ’ l- użu tiegħu fit- tiġieġ u jirrikmanda li Vaxxitek HVT+IBD jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn ir- riskju- benefiċċju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR.
Other information about Vaxxitek HVT+IBD:
Tagħrif ieħor dwar Vaxxitek HVT+IBD:
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaxxitek HVT+IBD to Merial S. A. S. on 9 August 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Vaxxitek HVT+IBD lil Merial S. A. S. fid- 9 ta ’ Awwissu 2002.
The Marketing Authorisation was subsequently renewed.
L- Awtorizzazzjoni għat - Tqegħid fis- Suq ġiet sussegwentament imġedda.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l- istejtus tal- preskrizzjoni ta ’ dan il - prodott jista ’ jinstab fuq it- tikketta/ pakkett ta ’ barra.
EU Number
Numru ta ’ l- UE Isem Inventat
Pharmaceutical form Target species
Speċi
EU/ 2/ 02/ 032/ 001 Vaxxitek
EU/ 2/ 02/ 032/ 001 Vaxxitek
Glass
Suspensjoni
1,000 doses 5-ampoule
Flieles ta ’ ġurnata
Zero days.
u Taħt
vHVT013-69 diluent for injection. and recombinant virus, at least 3.6 log10 PFU
Sustanza Attiva vHVT013- 69 vajrus rikombinat, mill- inqas 3. 6 log 10 PFU
18 day embryonated eggs.
ffriżata u dilwent għall - injezzjoni.
ampoule
Ampullett tal- ħġieġ
of vaccine carrier.
1, 000 doses 5- ampoule Zero days of vaccine carrier
Each dose of vaccine contains:
Kull doża tal- vaċċin fiha:
Live vHVT013-69 recombinant virus, at least.........................................................
- Sustanza Attiva vHVT013- 69 vajrus rikombinat, mill- inqas - Ingredjent mhux attiv
3.6 log10 PFU Excipient........................................................................................................................... qs 1 dose Diluent:
qs doża waħda
Frozen suspension and diluent for injection.
Suspensjoni ffriżata u dilwent għall- injezzjoni.
Day-old chickens and 18 days embryonated eggs.
Flieles ta ’ ġurnata u bajd embrijonat ta ’ 18- il ġurnata.
For active immunisation of chickens:
Għall- immunizzazzjoni attiva tal- flieles:
• To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
Biex tipprevjeni mwiet u biex tnaqqas sinjali kliniċi u leżjonijiet tal- marda infettiva Bursal.
The onset of protection is from 2 weeks and the protection extends to 9 weeks.
Il- protezzjoni tibda minn ġimgħatejn u testendi sa 9 ġimgħat.
• To reduce mortality, clinical signs and lesions of Marek’ s disease.
Biex tnaqqas l- imwiet, sinjali kliniċi u leżjonijiet tal- marda ta’ Marek.
The onset of protection is from 4 days.
Il- protezzjoni tibda minn erbat ijiem.
A single vaccination is sufficient to provide protection during the risk period.
Vaċċinazzjoni waħda hija biżżejjed biex tagħti protezzjoni waqt il- perjodu ta ’ riskju.
Vaccinate only healthy birds.
Laqqam biss tjur li huma f’ saħħithom.
Do not use in birds in lay and breeding birds.
Tużax fi tjur li qed ibidu u fi tjur li jkun għar- riproduzzjoni.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Applika il- prekawzzjonijiet asettiċi tas- soltu għall- proċeduri kollha ta ’ amministrazzjoni.
Safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Bħala vaċċin ħaj, dan jista jinxtered għad- dundjani mill- eskrement tat- tjur vaċċinati.
However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Testijiet għas - safety u għar- riverżjoni għall- virulenza urew li t- tip ta ’ vaċċin m’ hux ta’ periklu għad- dundjani.
2/ 21 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 21 Madanakollu miżuri ta ’ prekawzzjoni għandhom jittieħdu sabiex jiġi evitat kuntatt dirett jew indirett bejn flieles vaċċinati u dundjani.
Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Ilbes ingwanti protettivi u nuċċali waqt li l- kontenut ta ’ l- ampullett ikun qed idub u waqt li qed tiftaħ il- prodott.
Open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break.
Iftaħ l- ampulletti ‘ l bogħod minnek sabiex tipprevjeni kull riskju li tweġġa jekk jinkiser xi wieħed minnhom.
None known.
L- ebda effet magħruf.
Do not use in breeding birds and birds in lay.
Tużax fi tjur li jkun għar- riproduzzjoni jew fi żmien il- bajd.
No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’ s disease, Newcastle disease and Infectious bronchitis.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima meta tintuża flimkien ma vaċċin ieħor ħlief meta tintuża ma vaċċini attenwati ta ’ Merial kontra il- marda ta ’ Marek, il- marda ta ’ Newcastle, u l- Bronkite Infettiva. Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fi żmien 14 il- ġurnata wara t- tilqim b’ dan il- prodott.
It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Fin- nuqqas ta ’ studji speċifiċi, l- ebda tilqima oħra m’ għanda tiġi amministrata fl- istess żmien ma dan il- prodott bill- metodu in ovo.
In the absence of specific studies, no other vaccine should be administered concurrently with the product by the in ovo route
- Ilbes ingwanti protettivi u nuċċali waqt li l- kontenut ta ’ l- ampullett ikun qed idub u waqt il- ftuħ.
4.9 Amounts to be administered and administration route
- Neħħi mil- kontenitur tan- nitroġenu likwidu dawk l- ampulletti biss ji se tuża
4.9.1 Reconstitution of the vaccine
- Dewweb il- kontenut tal- ampulletti malajr billi tħawwad fl- ilma f’ temperatura ta ’ bejn 25 u 30˚
• Wear protective gloves and spectacles during the ampoule thawing and opening operations. • Remove from the liquid nitrogen container only those ampoules which are to be used immediately. • Thaw the contents of the ampoules rapidly by agitation in water at 25-30°C.
- Kif appena jdubu, iftaħ l- ampulletti waqt li żżommhom ‘ il bogħod minnek sabiex tipprevjeni
Proceed immediately to next step. • As soon as they are thawed, open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break. • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe. • Transfer the suspension into the diluent (Do not use if cloudy). • Draw up 2 ml of the contents of the diluent into the syringe. • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
- Ladarba l- ampullett jinfetaħ, iġbed il- kontenut tiegħu f’ siringa sterilizzata ta ’ 5 ml.
Repeat the rinsing operation once or twice. • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule per 200 ml of diluent for subcutaneous administration, or 4 ampoules per 200 ml of diluent for in ovo administration. • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
- Laħlaħ l- ampullett b’ dawn iż- 2 ml u mbagħad ittrasferixxi il- likwidu li laħlaħt bih fid- dilwent.
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Irrepeti l- operazzjonijiet tat- tidwib, tal- ftuħ, tat- trasferiment u tat- tlaħliħ, ghan- numru
This is why the vaccine suspension should only be prepared as and when required.
approprijat ta ’ ampulletti li għandhom jiġu rikostitwiti fid- dilwent; jew ampullet għal kull 200 ml ta ’ dilwent għall- użu taħt il- ġilda, jew 4 ampulletti għal kull 200 ml ta ’ dilwent għall– użu in ovo
4.9.2 Posology
- Ħawwad bil- mod il- vaċċin dilwit ippreparat kif hawn fuq deskritt sabiex ikun lest għall- użu.
One single injection of 0.2 ml per chicken at the age of one day, by subcutaneous route.
Din hi ir- raġuni għala is- suspensjoni tal - vaċċin għandu jiġi ppreparat kif u meta jinħtieġ biss.
One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by in ovo route.
3/ 21 DOŻAĠĠ Injezzjoni waħda ta ’ 0. 2 ml taħt il- ġilda għal kull fellus ta ’ ġurnata Injezzjoni waħda ta ’ 0. 05 ml bill- metodu in ovo għal kull bajda embrijonata ta ’ 18 il- ġurnata.
3/ 21 4.9.3 Method of administration
METODU TA ’ AMMINISTRAZZJONI
The vaccine must be administered by subcutaneous route or by in ovo route.
Il - vaċċin għandu jiġi amministrat taħt il - ġilda jew in ovo.
For in ovo administration, an automated egg injection machine can be used.
Għall- amministrazzjoni in ovo, tista jintuża apparat li jinjetta l- bajd awtomatikament.
The device should be proven to safely and effectively deliver the appropriate vaccinal dose.
Għandu jkun ippruvat li l- apparat jwassal b’ mod effettiv u mingħajr periklu, id- doża meħtieġa tal- vaċċin.
The instructions for use of this device should be strictly followed.
Għandhom jiġu segwiti bir- reqqa l- istruzzjonijiet għall- użu ta ’ dan l- apparat.
None known.
Xejn magħruf
ATCvet code QI01AD15
Kodici ATĊ veterinarja Q101AD15
Live recombinant vaccine against Infectious Bursal Disease and Marek’ s Disease.
Vaċċin attiv rikombinat kontra il- Marda Infettiva Bursal u l- Marda ta ’ Marek.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/ 70.
It- tip ta ’ vaċċin huwa il- Herpesvirus rikombinat tad- dundjani (HVT) li jesprimi l- antiġen protettiv (VP2) tal - Faragher 52/ 70 strain tal- virus (IBDV) tal- Marda Infettiva Bursal.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek’ s Disease in chickens.
Il - vaċċin jinduċi immunita ’ attiva u azzjoni seroloġika kontra il- Marda Infettiva Bursal u kontra il - Marda ta ’ Marek fit- tiġieġ.
Dimethyl sulfoxide Dilution medium
Suspensjoni virali ffriżata Dimethyl sulfoxide Medium tad- dilwit
Sucrose Casein hydrolysate Phenol red sodium salt Salts
Dilwent Sukrose Kaseina hydrolysate Phenol aħmar melħ tas- sodju Melħ
Use sterile and antiseptic-free and/ or disinfectant-free equipment for injections purposes.
Uża apparat sterilizzat u mingħajr antisettiku u/ jew diżinfettant għal skop ta ’ injezzjonijiet.
Do not mix with any other product except the diluent supplied for use with the product.
Tħallatx ma prodotti oħra ħlief id- dilwent fornit għall- użu mal- prodott.
Shelf-life of the non-reconstituted vaccine:
Żmien li l- vaċċin jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
36 months at – 196°C Shelf-life of the reconstituted vaccine: up to 2 hours at a temperature lower than 25°C.
36 xahar f’ temperatura ta ’ - 196˚.
Shelf-life of the diluent in polypropylene bottles:
Żmien li l- prodott jibqa 'tajjeb wara li jiġi rikostitwit: sa sagħtejn f’ temperatura inqas minn 25˚C Żmien li d- dilwent fi fliexken tal- polypropylene jibqa tajjeb:
12 months at a temperature lower than 30°C.
12- il xahar f’ temperatura inqas minn 30˚C.
Shelf-life of the diluent in polyvinylchloride bags:
4/ 21 Żmien li d- dilwent f’ boroż tal- polyvinychloride jibqa tajjeb:
36 months at a temperature lower than 30°C.
36 xahar f’ temperatura inqas minn 30˚C.
Store the vaccine in liquid nitrogen.
Aħżen il- vaċċin fin- nitroġenu likwidu.
Store the reconstituted vaccine at a temperature lower than 25°C.
Aħżen il- vaċċin imħallat f’ temperatura inqas minn 25°C.
Store the diluent at a temperature lower than 30°C, protected from light.
Aħżen id- dilwent f’ temperatura inqas minn 30°C, protett mid- dawl.
Avoid freezing and excessive temperatures.
Tiffriżax u evita temperaturi eċċessivi.
- (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
- ampullett (tal- ħġieġ) ta ’ 1000 doża ta ’ vaċċin, kontenitur ta ’ 5 ampulletti.
Ampoule carriers are stored in canister, and in liquid nitrogen containers.
Il- kontenituri tal- ampulletti huma maħzuna ġo kanister, u ġo kontenituri bin- nitroġenu likwidu.
- (polypropylene) bottle of 200 ml of diluent.
- Flixkun (tal- polypropylene) ta ’ 200 ml ta ’ dilwent.
- (polyvinylchloride) bag of 200 ml of diluent
- borża (tal- polyvinychloride) ta ’ 200 ml ta ’ dilwent
- (polyvinylchloride) bag of 400 ml of diluent
- borża (tal- polyvinychloride) ta ’ 400 ml ta ’ dilwent
- (polyvinylchloride) bag of 600 ml of diluent
- borża (tal- polyvinychloride) ta ’ 600 ml ta ’ dilwent
- (polyvinylchloride) bag of 800 ml of diluent
- borża (tal- polyvinychloride) ta ’ 800 ml ta ’ dilwent
- (polyvinylchloride) bag of 1000 ml of diluent
- borża (tal- polyvinychloride) ta ’ 1000 ml ta ’ dilwent
- (polyvinylchloride) bag of 1200 ml of diluent
- borża (tal- polyvinychloride) ta ’ 1200 ml ta ’ dilwent
- (polyvinylchloride) bag of 1400 ml of diluent
- borża (tal- polyvinychloride) ta ’ 1400 ml ta ’ dilwent
- (polyvinylchloride) bag of 1600 ml of diluent
- borża (tal- polyvinychloride) ta ’ 1600 ml ta ’ dilwent
- (polyvinylchloride) bag of 1800 ml of diluent
- borża (tal- polyvinychloride) ta ’ 1800 ml ta ’ dilwent
- (polyvinylchloride) bag of 2400 ml of diluent
- borża (tal- polyvinychloride) ta ’ 2400 ml ta ’ dilwent
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew 6. 6 materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Discard any ampoules that have been accidentally thawed.
Armi dawk l- ampulletti li ġew imdewwba bi żball.
Do not re-freeze under any circumstances.
Terġax tiffriżhom taħt l- ebda ċirkostanza.
Do not re-use opened containers of diluted vaccine.
Terġax tuża kontenituri miftuħa tal- vaċċin dilwit.
Destroy unused vaccine contents.
Iddistruġġi l- kontenut tal- vaċċin li ma ġiex użat.
Empty containers or contaminated equipment should be disposed of safely by boiling, incineration or by immersion in an appropriate disinfectant approved by competent authorities.
Eħles mill- kontenituri vojta jew xi materjal ikkontaminat billi tgħalli fil- misħun, taħraq jew billi tgħarraq ġo diżinfettant approvat mill- Awtorità Kompetenti tal- pajjiż.
6/ 21 ANNEX II
6/ 21 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID/ S - SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance(s)
Isem u indirizz tal- manufattur tas- sustanza( i) bioloġika( ċi) attiva( i)
Mérial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon France
Merial Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon France
Mérial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Merial Laboratoire Porte des Alpes Rue de l’ Aviation 69800 Saint- Priest France
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju bi preskrizzjoni.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR UŻU SIGUR U EFFETTIV
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, 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:
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;
Pharmacologically active substance
Sustanza farmakoloġikament attiva
Dimethyl sulfoxide
Dimethyl sulfoxide
Annex II:
Anness II:
Sodium hydrogen carbonate
Sodium hydrogen carbonate Aċidu Idrokloriku
Annex II (E500ii)
Anness II (E500ii) Anness II:
All food producing species (For use as excipient)
Kull speċje li jipproduċi l- ikel (Għall- użu bħala ingredjent)
Casein hydrolysate
Casein hydrolysate
Peptides and proteins naturally occurring - not within the scope of Council Regulation 2377/ 90.
Peptides u proteina li jifformaw b’ mod naturali – mhux fl- iskop tar- Regolament tal- Kunsill 2377/ 90.
Dipotassium phosphate Potassium dihydrogen
Fosfat tad- Dipotassium Potassium dihydrogen Phosphate (momopotassium phosphate)
Annex II (E340ii) Annex II (E340i)
Anness II (E340ii) Anness II (E340i)
Sodium hydroxide
Sodium hydroxide Ilma għall- injezzjonijiet
Not within the scope of Council Regulation 2377/ 90
Anness II (E524) mhux fl- iskop tar- Regolament tal- Kunsill 2377/ 90
For the following substances, the data provided by the Applicant were assessed and the substances considered not to be pharmacologically active at the doses used;
Għas- sustanzi li ġejjin, l- informazzjoni mgħotija mill- applikant kienet studjata u s- sustanzi kunsidrati mhux farmakoloġikament attivi fid- dożi wżati;
F10 HAM Medium 199 medium Phenol red Gentamicin
F10 HAM Medju 199 medju Phenol aħmar Ġentamicin
9/ 21 ANNEX III
9/ 21 ANNESS III
LABELLING AND PACKAGE INSERT
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
11/ 21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
{AMPOULE 1000 doses}
AMPULLETT 1000 doża
1000 doses
1000 doża
SC or in ovo route
SC jew in ovo
12/ 21 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE STERILE DILUENT
12/ 21 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
STERILE DILUENT
DILWENT STERILIZZAT
1 bottle of 200 ml
flixkun ta ’ 200 ml
1 bag of 2400 ml
borża ta ’ 200 ml borża ta ’ 400 ml borża ta ’ 600 ml borża ta ’ 800 ml borża ta ’ 1000 ml borża ta ’ 1200 ml borża ta ’ 1400 ml borża ta ’ 1600 ml borża ta ’ 1800 ml borża ta ’ 2400 ml
Read the package leaflet enclosed in the vaccine vial before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Use immediately after preparation.
Uża mmedjatament wara l- preparazzjoni.
Do not use if cloudy.
Tużax jekk imdardar.
Store at a temperature lower than 30°C.
Aħżen f' temperaturi anqas minn 30°C.
Avoid freezing or excessive temperatures.
Evita l- friża u temperaturi eċċessivi.
MERIAL 29 Avenue Tony Garnier 69007 Lyon France
MERIAL 29 avenue Tony Garnier 69007 Lyon France
15/ 21 PACKAGE LEAFLET (VACCINE SUSPENSION) Vaxxitek HVT+IBD
15/ 21 FULJETT TA ’ TAGĦRIF FIL- PAKKETT (SUSPENSJONI GĦAL VAĊĊIN) Vaxxitek HVT+IBD
Marketing authorisation holder MERIAL 29 Avenue Tony Garnier 69007 Lyon, France
Sid l- Awtorizzazzjoni tal- Kummerċ MERIAL 29 avenue Tony Garnier 69007 Lyon, France
Manufacturer for batch release MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, F-69800 Saint-Priest France
Manifattur li jħalli l- konsenja tmur fis- suq MERIAL Laboratorju ta ’ Lyon Porte des Alpes Rue de l’ Aviation F- 69800 Saint- Priest France
Suspension:
Suspensjoni: - -
Live vHVT013-69 recombinant virus, at least.........................................................
Sustanza Attiva vHVT013- 69 vajrus rikombinat, mill- inqas......................
3.6 log10 PFU Excipient........................................................................................................................... qs 1 dose Diluent:
Ingredjent mhux attiv
INDICATION(S)
3. 6 log 10 PFU qs doża waħda
For active immunisation of chickens:
Dilwent: -
• To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
qs doża waħda
The onset of protection is from 4 days.
INDIKAZZJONI (JIET)
A single vaccination is sufficient to provide protection during the risk period.
Il- protezzjoni tibda minn ġimgħatejn u testendi sa 9 ġimgħat.
Do not use in birds in lay and breeding birds.
Tużax fi tjur li qed ibid u fi tjur li jkun għar- riproduzzjoni.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
L- ebda effett magħruf Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
Subcutaneous or in ovo route.
Taħt il - ġilda jew in ovo.
For in ovo administration, an automated egg injection machine can be used.
Għall- amministrazzjoni in ovo, jista jintuża apparat li jinjetta l- bajd awtomatikament.
Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day.
Taħt il- ġilda: injezzjoni waħda ta ’ 0. 2 ml għal kull fellus ta ’ ġurnata.
In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation.
Injezzjoni waħda ta ’ 0. 05 ml għal kull bajda fit- 18– il ġurnata ta ’ embrijoniżżazzjoni
• Wear protective gloves and spectacles during the ampoule thawing and opening operations. • Remove from the liquid nitrogen container only those ampoules which are to be used immediately. • Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C.
- Ilbes ingwanti protettivi u nuċċali waqt li l- kontenut ta ’ l- ampullett ikun qed idub u waqt il- ftuħ.
Repeat the rinsing operation once or twice.
- Iġbed 2 ml tal- kontenut tad- dilwent għal ġo s- siringa.
Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule per 200 ml of diluent for subcutaneous administration, or 4 ampoules per 200 ml of diluent for in ovo administration. • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Irrepeti l- operazzjonijiet tat- tidwib, tal- ftuħ, tat- trasferiment u tat- tlaħliħ, ghan- numru approprijat ta ’ ampulletti li għandhom jiġu rikostitwiti fid- dilwent; jew ampullet għal kull 200 ml ta ’ dilwent għall- użu taħt il- ġilda, jew 4 ampulletti għal kull 200 ml ta ’ dilwent għall– użu in ovo.
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Għandu jiġi wżat immedjatament wara li jiġi ppreparat (il - vaċċin dilwit kollu għandu jiġi wżat fi żmien siegħa).
This is why the vaccine suspension should only be prepared as and when required
Din hi ir- raġuni għala is- suspensjoni tal - vaċċin għandu jiġi ppreparat kif u meta jinħtieġ biss.
Do not use after the expiry date stated on the ampoule.
Tużax wara d- data tal- iskadenza fuq l- ampullett.
Apply the usual aseptic precautions to all administration procedures.
Applika il- prekawzzjonijiet asettiċi tas- soltu għall- proċeduri kollha ta ’ amministrazzjoni.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Bħala vaċċin ħaj, dan jista jinxtered għad- dundjani mill- eskrement tat- tjur vaċċinati.
Safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Testijiet għas - safety u għar- riverżjoni għall- virulenza urew li t- tip ta ’ vaċċin m’ hux ta’ periklu għad- dundjani.
However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Madanakollu miżuri ta ’ prekawzzjoni għandhom jittieħdu sabiex jiġi evitat kuntatt dirett jew indirett bejn flieles vaċċinati u dundjani.
Do not use in breeding birds and birds in lay.
Tużax fi tjur li qed ibidu u fi tjur li jkun għar- riproduzzjoni.
No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’ s disease, Newcastle disease and Infectious bronchitis.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima meta tintuża flimkien ma vaċċin ieħor ħlief meta tintuża ma vaċċini attenwati ta ’ Merial kontra il- marda ta ’ Marek, il- marda ta ’ Newcastle, u l- Bronkite Infettiva.
It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fi żmien 14 il- ġurnata wara t- tilqim b’ dan il- prodott.
In the absence of specific studies, no other vaccine should be administered concurrently with the product by the in ovo route
Fin- nuqqas ta ’ studji speċifiċi, l- ebda tilqima oħra m’ għanda tiġi amministrata fl- istess żmien ma dan il- prodott bill- metodu in ovo.
Empty containers or contaminated equipment should be disposed of safely, by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Eħles mill - kontenituri vojta jew xi materjal ikkontaminat billi tgħalli fil- misħun, taħraq jew billi tgħarraq ġo diżinfettant approvat mill- Awtorità Kompetenti tal- pajjiż.
Live recombinant vaccine against Infectious Bursal Disease and Marek’ s Disease.
Vaccin attiv rikombinat kontra il- Marda Infettiva Bursal u l- Marda ta ’ Marek.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/ 70.
It- tip ta ’ vaċċin huwa il- Herpesvirus rikombinat tad- dundjani (HVT) li jesprimi l- antiġen protettiv (VP2) tal- Faragher 52/ 70 strain tal- virus (IBDV) tal- Marda Infettiva Bursal.
Veterinary medicinal product subject to prescription.
Prodott veterinarju mediċinali suġġett għar- ricetta.
19/ 21 PACKAGE LEAFLET (STERILE DILUENT) STERILE DILUENT
19/ 21 FULJETT TA ’ TAGĦRIF FIL- PAKKETT (DILWENT STERILIZZAT) DILWENT STERILIZZAT
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, F-69800 Saint-Priest France
MERIAL Laboratorju ta ’ Lyon Porte des Alpes Rue de l’ Aviation F- 69800 Saint- Priest France
Chickens.
Tiġieġ
Read the package leaflet enclosed in the vaccine vial.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
Frozen vaccines:
Vaċċini ffriżati:
Proceed immediately to next step. • As soon as they are thawed, open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break. • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
- Ladarba l- ampullett jinfetaħ, iġbed il- kontenut tiegħu f’ siringa sterilizzata ta ’ 5 ml.
20/ 21 • Transfer the suspension into the diluent. • Draw up 2 ml of the contents of the diluent into the syringe. • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
20/ 21
Repeat the rinsing operation once or twice. • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule per 200 ml of diluent for subcutaneous administration, or 4 ampoules per 200 ml of diluent for in ovo administration. • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
approprijat ta ’ ampulletti li għandhom jiġu rikostitwiti fid- dilwent; jew ampullet għal kull 200 ml ta ’ dilwent għall- użu taħt il- ġilda, jew 4 ampulletti għal kull 200 ml ta ’ dilwent għall– użu in ovo.
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Għandu jiġi wżat immedjatament wara li jiġi ppreparat (il- vaċċin dilwit kollu għandu jiġi wżat fi żmien siegħa).
This is why the vaccine suspension should only be prepared as and when required.
Din hi ir- raġuni għala is- suspensjoni tal- vaċċin għandu jiġi ppreparat kif u meta jinħtieġ biss.
Store at a temperature lower than 30°C.
Aħżen f’ temperatura inqas minn 30˚C.
Avoid freezing or excessive temperatures
Tiffriżax u evita temperaturi eċċessivi.
Any unused container or waste materials should be disposed of in accordance with the local requirements.
Xi kontenituri mhux użati jew materjal żejjed għandhom jiġu mormija skond id- dispożizzjonijiet tal - pajjiż.
This diluent may be used with the following products:
Dan id- dilwent jista jintuża ma dawn il- prodotti li ġejjin:
VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 5MU għal klieb u qtates VIRBAGEN OMEGA 10MU għal klieb u qtates
Vial containing lyophilisate:
Kunjett li fih lyophilisate:
Active substance:
Sustanza attiva
5 MU presentation:
Preżentazzjoni ta '5MU:
Recombinant Omega interferon of feline origin 5 MU*/ vial
Omega interferon rikombinanti li joriġina mill- qtates
10 MU presentation:
Preżentazzjoni ta '10MU:
Recombinant Omega interferon of feline origin 10 MU*/ vial
Omega interferon rikombinanti li joriġina mill- qtates
Million Units
Miljun Unità
Vial containing solvent:
Kunjett li fih solvent:
Isotonic sodium chloride solution
Soluzzjoni ta 'sodium chloride
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti mhux attivi, ara s - sezzjoni 6. 1
Lyophilisate and solvent for suspension for injection.
Sustanza lijofilizzanti u solvent għal suspensjoni għall- injezzjoni
Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.
Tnaqqis fil- mortalità u sinjali kliniċi ta 'parvovirosi (forma enerika) fil- klieb sa mill- età ta' xahar.
Treatment of cats infected with FeLV and/ or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Kura ta 'qtates infettati b' FeLV u/ jew FIV, fi stadji kliniċi mhux terminali, mill- età ta' 9 ġimgħat.
In a field study conducted, it was observed that there was:
Fi studju li twettaq fil- kamp, kien osservat li kien hemm:
- a reduction of clinical signs during the symptomatic phase (4 months)
- tnaqqis ta 'sinjali kliniċi matul il- fażi sintomatika (4 xhur)
- a reduction of mortality:
- tnaqqis fil- mortalità:
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. • in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon.
• fil- qtates anemiċi, ir- rata tal- mortalità ta 'madwar 60% f' 4, 6, 9 u 12- il xahar tnaqqset b' madwar 30% wara l- kura b' interferon. • fil- qtates mhux anemiċi, ir- rata tal- mortalità ta' 50% fil- qtates infettati b' FeLV tnaqqset b' 20% wara l- kura b' interferon.
In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
Fi qtates infettati minn FIV, il- mortalità kienet baxxa (5%) u ma kinetx influwenzata mill- kura.
2/ 31 4.3 Contraindications
2/ 31 4. 3 Kontra- indikazzjonijiet
Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
It- tilqim matul u wara l- kura b’ VIRBAGEN OMEGA hu kontra- indikat, sakemm il- kelb jidher li jkun qed jirkupra.
Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/ FIV infections, the effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Qtates: minħabba li t- tilqim hu kontra- indikat fil- fażi sintomatika ta 'infezzjonijiet FeLV/ FIV, l- effett ta' VIRBAGEN OMEGA fuq il- tilqim tal- qtates ma kienx evalwat.
No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders.
M' hemm l- ebda tagħrif disponibbli fuq l- induzzjoni ta 'l- effetti sekondarji fuq tul ta' żmien fil- klieb u l - qtates, speċjalment għal mard awtoimmuni.
Such side effects have been described after multiple and long-term administration of type I interferon in man.
Effetti sekondarji bħal dawn kienu deskritti wara l- għoti multiplu u fit- tul ta 'interferon ta' tip I fil- bniedem.
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/ FIV infections.
Għalhekk, il- possibbiltà li jseħħ mard awtoimmuni f' annimali kkurati ma tistax tiġi eskluża u trid tiġi bbilanċjata bir- riskju assoċjat ma 'infezzjonijiet FeLV/ FIV.
Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.
L- effikaċja tal- prodott fuq il- qtates b' forma tumuruża ta 'l- infezzjoni minn FeLV, jew qtates infettati minn FeLV jew ko- infettati minn FIV fi stadji terminali ma kinetx ittestjata.
In the case of intravenous administration in cats, increased adverse reactions may be seen, e. g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
Fil- każ ta 'għoti ġol- vina fil- qtates, tista' sseħħ żieda ta 'reazzjonijiet avversi, eż. ipertermija, ippurgar artab, anoreksja, nuqqas fix- xorb jew kollass.
Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Klieb u qtates: intwera li konformità stretta mal- pożoloġija rakkomandata hi mandatorja biex jintlaħaq il- benefiċċju kliniku.
In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
Fil- każ ta 'kura ripetuta ta' mard kroniku marbut ma 'epatite, ħsara fil- qalb u fil- kliewi, il- marda korrispondenti għandha tkun immonitorjata qabel l- għoti ta' VIRBAGEN OMEGA.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
Fil- każ ta 'li tinjetta lilek innifsek b’ mod aċċidentali, fittex parir mediku minnufih u uri l- fuljett tal - pakkett jew it- tikketta lit- tabib.
In some cases, during treatment, the following transitory clinical signs may be observed in dogs and cats: • hyperthermia (3-6 hours after injection) • vomiting • soft faeces to mild diarrhoea, in cats only.
F' xi każijiet, waqt il- kura, dawn is- sinjali kliniċi transitorji tista 'tiġi osservata fil- klieb u l- qtates: • ipertermija (3- 6 sigħat wara l- injezzjoni) • rimettar • ippurgar artab sa dijarea ħafifa, fil- qtates biss.
In addition, a slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase may be observed.
Flimkien ma 'dan, tnaqqis żgħir fiċ- ċelluli tad- demm bojod, pjetlets u ċelluli tad- demm ħomor, u żieda fil- konċentrazzjoni ta' alanine aminotransferase tista 'tiġi osservata.
These parameters return to normal in the week following the last injection. • transient fatigue during the treatment, in cats only.
Dawn il- parametri jerġgħu lura għan- normal fil- ġimgħa ta 'wara l- aħħar injezzjoni. • għeja temporanja waqt il- kura, fil- qtates biss.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Is- sigurtà tal- prodott mediċinali veterinarju ma kinetx stabbilita matul it- tqala u t- treddigħ.
The use of supplementary supportive treatments improves prognosis.
L- użu ta 'kuri ta' sapport supplimentari jtejbu il- pronjosi.
No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration,
Madankollu, minħabba li tagħrif
However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/ benefit analysis.
3/ 31 speċifiku dwar interazzjonijiet possibbli ta 'interferon ma' prodotti oħrajn hu nieqes, kuri ta 'sapport supplimentari għandhom jintużaw bl- attenzjoni u wara analiżi bir- reqqa tar- riskju/ benefiċċju.
No information is available on the safety and efficacy from the concurrent use of this product with any vaccine.
L- ebda tagħrif mhu disponibbli dwar is- sigurtà u l- effikaċja mill- użu fl- istess ħin ta 'dan il- prodott ma' kawalukwe vaċċin.
For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered.
Għal klieb, hu rakkomandat li l- ebda vaċċini m' għandhom jingħataw sakemm l - annimal ikun jidher li rkupra.
Cat vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
It- tilqim tal- qtates matul u wara l- kura b' VIRBAGEN OMEGA hu kontra- indikat għax kemm infezzjonijiet FeLV u kemm dawk FIV huma magħrufa li huma immunosoppressivi.
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain, depending on the presentation, a suspension containing 5 MU or 10 MU of recombinant interferon.
Il- porzjon freeze- dried irid ikun rikostitwit b' 1ml tad- dilwent speċifiku biex tinkiseb, skond il - preżentazzjoni, suspensjoni li fiha 5MU jew 10MU ta 'interferon rikombinanti.
The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Il- prodott rikostitwit għandu jkun injettat ġol- vina darba kuljum għal 3 ijiem konsekuttivi.
The dose is 2.5 MU/ kg bodyweight.
Id- doża hi ta '2. 5MU/ kg ta' piż tal- ġisem.
The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Il- prodott rikostitwit għandu jkun injettat taħt il- ġilda darba kuljum għal 5 ijiem konsekuttivi.
The dose is 1 MU/ kg bodyweight.
Id- doża hi ta '1MU/ kg ta' piż tal- ġisem.
Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Tliet kuri separati ta '5 ijiem iridu jitwettqu f' jum 0, jum 14 u jum 60.
The product should be used with the accompanying solvent only.
Il- prodott għandu jintuża biss mas- solvent li jkun jakkompanjah.
After a tenfold overdose in both dog and cat the following clinical signs have been observed:
Wara żieda ta 'għaxar darbiet iktar min- normal kemm fil- klieb u kemm fil- qtates, is- sinjali kliniċi li ġejjin kienu osservati:
• mild lethargy and drowsiness • slight increase of body temperature. • slight increase of respiratory rate • slight sinus tachycardia.
• letarġija ħafifa u ngħas • żieda ħafifa tat- temperatura tal- ġisem. • żieda ħafifa tar- rata respiratorja • takikardija tas- sinus ħafifa.
These clinical signs disappear within 7 days without any particular treatment.
Dawn is- sinjali kliniċi jgħibu fi żmien 7 ijiem mingħajr xi kura partikulari.
4.11 Withdrawal period(s)
4. 11 Perjodu ta 'tiżmim
Interferons ATCvet code:
Interferons Kodiċi ATCvet:
Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
Omega interferon li joriġina mill- qtates, prodott minn inġinerija ġenetika, hu tip ta 'Ι interferon li hu marbut mill- qrib ma' alpha interferon.
The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV).
Il- mekkaniżmu ta 'l- azzjoni eżatt ta' interferon omega mhuwiex magħruf perfettament, iżda jista 'jinvolvi it- titjib tad- difiża mhux speċifika tal- ġisem, b' mod partikulari fil- klieb kontra parvovirosi kanina u fil- qtates kontra retrovirosi felina (FeLV, FIV).
Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
Interferon ma jaġixxix direttament u b' mod speċifiku fuq il- vajrus, iżda jeżerċita l- effett tiegħu bl- inibizzjoni tal- mekkaniżmi tas- sintesi interna taċ- ċelluli infettati.
4/ 31 5.2 Pharmacokinetic particulars
4/ 31 5. 2 Tagħrif farmakokinetiku
After injection it is quickly bound to specific receptors of a large variety of cells.
Wara l- injezzjoni jeħel malajr ma 'riċetturi speċifiċi ta' varjetà kbira ta 'ċelluli.
It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5 'oligo-adenylate synthetase activation).
Ġeneralment, il - mekkaniżmu tar- replikazzjoni jitwaqqaf kemm bil- qerda ta 'mRNA u kemm mid- diżattivazzjoni tal - proteini tat- traduzzjoni (attivazzjoni 2' 5' oligo- adenylate synthetase) fiċ- ċelluli infettati mill- vajrus.
Sodium hydroxide 0.2 M, sodium chloride, D-Sorbitol, purified gelatin of porcine origin.
Sodium hydroxide 0. 2M, sodium chloride, D- Sorbitol, purified gelatin of porcine origin.
The product should be used immediately after reconstitution.
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
6.4.
Sentejn.
Store and transport at 4°C ± 2°C.
Aħżen u ittrasporta f' temperatura ta '4°C ± 2°C.
Store in the original carton.
Aħżen fil- kartuna oriġinali.
For the 5MU presentation:
Għal preżentazzjoni ta '5MU:
Box containing 5 vials (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 5 vials (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Kaxxa b' 5 kunjetti (tal- ħġieġ b' tappijiet magħmula minn polimer tal- gomma ’ u miksija b’ resin ta’ polimer tal- florokarbon) li fihom il - porzjon tat- trab u 5 kunjetti (tal- ħġieġ b' tapp tal- gomma) b' 1ml ta 'solvent.
For the 10MU presentation:
Għall- preżentazzjoni ta '10MU:
Box containing 1 vial (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 1 vial (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Kaxxa b' kunjett 1 (tal- ħġieġ b' tappijiet magħmula minn polimer tal- gomma ’ u miksija b’ resin ta’ polimer tal- florokarbon) li fih il - porzjon tat- trab u kunjett 1 (tal- ħġieġ b' tapp tal- gomma) b' 1ml ta 'solvent.
Box containing 2 vials (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 2 vials (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Kaxxa b' 2 kunjetti (tal- ħġieġ b' tappijiet magħmula minn polimer tal- gomma ’ u miksija b’ resin ta’ polimer tal- florokarbon) li fihom il - porzjon tat- trab u 2 kunjetti (tal- ħġieġ b' tapp tal- gomma) b' 1ml ta 'solvent.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kwalunkwe prodott mediċinali veterinarju li jew prodotti għar- rimi li jkunu ġejjin minn prodotti mediċinali veterinarji bħal dawn, għandhom jintremew skond il- ħtiġijiet lokali.
1ère Avenue - 2065 m 06516 CARROS France
1ère Avenue - 2065 m 06516 CARROS Franza
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europ. eu/.
Tagħrif dettaljat dwar dan il- prodott mediċinali veterinarju hu disponibbli fuq is- sit ta 'l- Internet tal - European Medicines Agency (EMEA) http: // www. emea. eu. int /