qanastek/EMEA-V3 huggingface dataset:
The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Il- frieħ tal - ħnieżer kellhom livelli komparabbli ta ’ antikorpi kontra r- rinite atrofika progressiva kif miksuba ma ’ tilqima oħra approvata.
In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).
Fl- istudju dwar kemm idum l- effett, ibbażat fuq il- livelli ta ’ l- antikorpi, intwera li t- tilqima mill- ġdid b’ doża waħda wasslet għal rispons ċar ta ’ booster (jiġifieri, il- livelli ta ’ antikorpi li rriżultaw kienu saħansitra ogħla minn dawk wara t- tilqima bażika).
What are the side effects of Porcilis AR-T DF?
X’ inhuma l- effetti sekondarji ta ’ Porcilis AR- T DF?
Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5 °C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Porcilis AR- T DF jista ’ jikkawża żieda temporanja fit- temperatura tal- ġisem b’ 1. 5 °C, u f’ xi ħnieżer żieda sa 3°C fil- jum tat- tilqima jew l- għada.
Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/ or a temporary swelling (max diameter:
Effetti sekondarji oħra huma tnaqqis fl- attività u nuqqas t’ aptit f’ bejn 10 u 20% tal- ħnieżer fil- jum tat- tilqima u/ jew nefħa temporanja (dijametru massimu:
10 cm) for up to two weeks at the injection site.
10 ċm) għal mhux iktar minn ġimgħatejn fis- sit ta ’ l- injezzjoni.
Porcilis AR-T DF contains mineral oil.
Porcilis AR- T DF ikun fih żejt minerali.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger.
Injezzjoni aċċidentali tista ’ tikkawża uġigħ sever u nfiħ, partikolamrent jekk jiġi injettat f’ ġog jew seba ’ – rarament anke jwassal għat- telf ta ’ seba ’.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Jekk xi ħadd jitniggeż aċċidentalment b’ dan il- prodott, għandu jkellem tabib immedjatament, anke jekk jiġi injettat biss ammont żgħir ħafna.
The Package Leaflet should be taken to the doctor.
Il- Fuljett ta ’ Tagħrif għandu jingħata lit- tabib.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Jekk l- uġigħ idum iktar minn 12- il siegħa wara l- eżaminazzjoni medika, it- tabib għandu jiġi kkuntattjat mill- ġdid.
Why has Porcilis AR-T DF been approved?
Għaliex ġie approvat Porcilis AR- T DF?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF are greater than any risks to reduce the clinical signs of progressive atrophic rhinitis in piglets.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l- benefiċċċji ta ’ Porcilis AR- T DF huma ikbar mir- riskji tiegħu fit- tnaqqis ta ’ sinjali kliniċi tar- rinite atrofika progressiva fil - ħnieżer żgħar.
They recommended that Porcilis AR-T DF should be given a marketing authorisation.
Irrakkomandaw li Porcilis AR- T DF jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il - bilanċ bejn il- benefiċċju u r- riskju jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Porcilis AR-T DF:
Tagħrif ieħor dwar Porcilis AR- T DF:
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B. V. on 16 November 2000.
Il- Kummissjoni Ewopea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Porcilis AR- T DF lil Intervet International B. V. fis- 16 ta ’ Novembru tas- sena 2000.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq il- pakkett ta ’ barra.
This summary was last updated in 11-2006.
Dan is- Sommarju ġie aġġornat l- aħħar f’ Novembru ta ’ l- 2006.
Porcilis AR-T DF suspension for injection
Porcilis AR- T DF suspensjoni għal injezzjoni
Per dose of 2 ml
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
- Protein dO (non-toxic deletion derivative of Pasteurella multocida
Għall kull doża ta ’ 2 ml
- Inactivated 1
Protein dO (derivattiv mhux tossiku minn velenu dermo- nekrotiku ta ’ Pasteurella multocida > 5. 9Log2 TN tajter1 > 4. 2 log2 Aggl. tajter2 Ċelloli inattivati ta ’ Bordatella bronchiseptica 1 Tajter medju li nnewtralizza l- velenu wara vaċċinazjoni ripetuta ta ’ nofs doża fil- fniek.
Per dose of 2 ml
2 Tajter ta ’ agglutinazjoni medju wara vaċċinazjoni waħda ta ’ nofs doża fil- fniek
- 150 mg dl-α -tocopherol acetate.
Għal kull doża ta ’ 2 ml 150 mg ta ’ dl- alpha – tocopherol acetate
Excipients:
Eċċipienti:
Per dose of 2 ml max 1.0 mg free formaldehyde.
Għal kull doża ta ’ 2 ml Massimu ta ’ milligramma formalina fl- istat liberu
Suspension for injection.
Suspensjoni għal injezzjoni
Pigs (sows and gilts).
Majjala u majjala ta ’ l- ewwel
For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Għat - tnaqqis tas- sintomi kliniċi ta ’ rinite atrofika progressiva fil- qżieqeż permezz ta ’ immunita passiva orali li jieħdu meta jixorbu l- kolostrum ta ’ ommijiet li kienu ġew imlaqqma kontra l - marda.
Before using the vaccine allow it to reach room temperature (15°C - 25°C) and shake vigorously.
Qabel ma tuża l - vaċċin ħalliha tilħaq it- temperatura tal- kamra (15oĊ – 25oĊ).
Vaccinate only healthy animals.
Ħawwad sewwa qabel tuża.
Avoid introduction of contamination.
Laqqam biss animali f’ saħħithom.
2/ 17 Special precautions to be taken by the person administering the medicinal product to animals
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'nformazzjoni li jkun fih ġewwa.
A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C can generally be measured on the day of vaccination or the following day.
Majjali trattati wrew żieda medja ta ’ 1. 5o Ċ fit- temperatura tal- ġisem, f’ xi majjali kien hemm żieda anke sa 3oĊ, fil- ġurnata tal- vaċċinazzjoni jew l- għada.
10 cm) for up to two weeks may arise at the site of injection.
Tnaqqis fl- attivita u fl- ikel jistgħu iseħħu f’ madwar 10 - 20% tal- annimali fil- ġurnata tal- vaċċinazzjoni, u/ jew xi nefħa (dijametru massimu ta ’ 10 ċentimetri) jistgħu iseħħu sa ġimgħatejn wara fil- post fejn ingħatat l- injezzjoni.
This product can be used during pregnancy.
Jista 'jintuża waqt it- tqala.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar l- effett u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor.
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.
Għalhekk wieħed m’ għandux ilaqqam b’ vaċċin ieħor fi żmien 14- il jum qabel jew wara li jintuża dan il- prodott.
The vaccine should preferably be administered just behind the ear.
Doża waħda ta ’ 2 millilitri għandha tiġi njettata intramuskularment lil majjali minn 18 il- ġimgħa l- fuq preferibilment wara l- widna.
Vaccination scheme:
Skeda ta ’ vaċċinazzjoni:
Basic vaccination: inject one dose per pig, followed by a second injection 4 weeks after the first injection.
L- ewwel darba: injetta doża waħda ghal kull majjala, b’ doża oħra warajha erba ’ ġimgħat wara.
The first injection should be administered 6 weeks before the expected date of farrowing.
L- ewwel tilqima għandha tingħata 6 ġimgħat qabel ma jferraw.
Revaccination: a single injection of one dose should be carried out 2 – 4 weeks prior to each subsequent farrowing.
Revaċċinazzjoni: injezzjoni waħda għandha tinghata minn 2 sa 4 ġimgħat qabel kull twelid li jiġi wara.
Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than already mentioned under point 4.6 can be expected.
Minbarra ż- żieda medja fit- temperatura tal- ġisem dak in- nhar tal- vaċċinazzjoni jew l- għada, wieħed m’ għandux jistenna reazzjonijiet oħra mhux mixtieqa għajr dawk imsemmija f’ punt 4. 6
Pharmacotherapeutic group: inactivated bacterial vaccine.
Grupp farmakoterapewtiku:
ATCvet code:
Vaċċin magħmul minn bakterja inattivata.
QI09AB04.
Kodiċi veterinarja ATC QI09AB04.
To stimulate active immunity in order to provide passive immunity to atrophic rhinitis.
Il- vaċċin jistimula immunita ’ attiva biex imbagħad dawn jgħaddu immunita passiva liż- żgħar tagħhom kontra rinite atrofika progressiva.
Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
3 Pasteurella multocida li tipproduċi velenu dermo- nekrotiku huwa l- patoġenu li responsabbli ġħall - qerda ta ’ passaġġi fl- imnifsejn f’ rinite atrofika progressiva.
Colonisation of the surface of the nasal mucosa by Pasteurella multocida is most often promoted by Bordetella bronchiseptica.
Il- kolonizzazzjoni tal- mukosa fl- imnifsejn mill- Pasteurella multocida huwa ħafna drabi mgħejjun minn Bordetella bronchiseptica.
The
Il - vaċċin fih derivattiv rikombinant mhux tossiku tal - velenu tal- Pasteurella multocida u ċelloli inattivati tal - Bordetella bronchiseptica.
3/ 17 immunogens are incorporated in an adjuvant based on dl-α -tocopherol.
L- immunoġeni huma nkorporati fl- adjuvant bbażat fuq dl- alpha – tocopherol.
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/ gilts.
Il- qżieqeż żgħar jieħdu l- immunita meta jixorbu l- kolostrum minn majjaliet vaċċinati.
6.1 Incompatibilities
6. 1 Inkompatibilitajiet
6.2 Shelf-life
6. 2 Żmien ta 'kemm il- prodott idum tajjeb
Shelf-life after first opening the vial:
Żmien li l- prodott jibqa 'tajjeb wara li jinfetaħ:
10 hours.
10 siegħat
6.3 Special precautions for storage
6. 3 Tagħrif speċjali dwar kif għandu jinħażen
Do not freeze.
Aħżen fil- friġġ (2°C – 8°C) Tiffriżax
6.4 Nature and composition of immediate packaging
6. 4 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Cardboard box containing one 20 or 50 ml multi-dose vial of hydrolytic Type I glass or polyethylene terephthalate [PET], closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Kaxxa tal- kartun li fiha kunjett ta ’ 20 jew 50 millilitru, magħmul minn ħġieġ (idrolitiku tip 1) jew polyethylene terephtalate (PET), u magħluq b’ tapp tal- lastiku tat - tip halogenobutyl u ssiġillat b’ kappa tal - aluminjum.
6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 5 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V Wim de Korverstraat 35 5831 AN Boxmeer L- Olanda
DATE OF THE FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
Date of first authorisation:
4 Data ta’ l- ewwel awtorizzazjoni:
16 November 2000 Date of last renewal:
16 ta ’ Novembru 2000 Data ta ’ l- aħħar reviżżjoni:
8 February 2006
8 ta ’ Frar 2006
The import, sale, supply and/ or use of Porcilis AR-T DF is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provista u / jew l- użu ta 'Porcilis AR- T DF huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Porcilis AR-T DF must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Porcilis AR- T DF għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U > SID (/ S - SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substances:
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Korverstraat 35 5831 AN BOXMEER L - OLANDA
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju. >
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Council Regulation (EEC) 2377/ 90.
Peress illi s- sustanza attiva hija ta’ oriġini bijoloġika u ntenzjonata biex tipproduċi immunita attiva, ma taqax taħt ir- Regoalment tal- Kunsill (KE) Nru 2377/ 90.
7/ 17 The MRL status of the excipients is as follows:
L- istat tal- MRL tas- sustanzi mhux attivi huwa kif ġej:
Annex II of Council Regulation (EEC) No 2377/ 90 Substance Sodium chloride Formaldehyde dl-α -tocopherol acetate Simethicone (Dimethicone) Disodium phosphate dihydrate
Anness II tar- Regolamenti tal- Kunsill (KE) Nru 2377/ 90
MRL status All food-producing animals
Stat MRL
L 290 of 5.12.95 OJ No.
L 290 of 5. 12. 95 OJ No.
L 122 of 12.05.99 OJ No L 290 of 5.12.95 OJ No L 272 of 25.10.96
L 122 of 12. 05. 99 OJ No L 290 of 5. 12. 95 OJ No L 272 of 25. 10. 96
Potassium dihydrogen phosphate
Potassium dihydrogen phosphate
8/ 17 ANNEX III
8 ANNESS III
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
- ≥ 5.9 log2 TN titre1 Protein dO
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Titre1 inactivated B. bronchiseptica cells
Għall kull doża ta ’ 2 ml ≥ 5. 9Log2 TN tajter1 Protein dO ≥ 4. 2 log2 Aggl.
1 See package leaflet.
Tajter1 Ċelloli inattivati ta ’ Bordatella bronchiseptica 1 Ara l- fuljett tal- informazzjoni
150 mg dl-α -tocopherol acetate
150 mg ta ’ dl- alpha – tocopherol acetate
20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial
20 ml (10 dożi) kunjett tal- ħġieġ 50 ml (25 dożi) kunjett tal- ħġieġ 20 ml (10 dożi) kunjett PET 50 ml (25 dożi) kunjett PET
Vaccine against progressive atrophic rhinitis.
Tilqima kontra r- rinite atrofika progressiva
i. m. injection of 2 ml Read the package leaflet before use.
Injezzjoni ta’ 2ml fil- muskolu Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
EXP {month/ year} Once broached, use within 10 hours.
DATA TA 'SKADENZA
Do not freeze.
Aħżen fil- friġġ Tiffriżax
NL-5831 AN Boxmeer
NL- 5831 AN BOXMEER
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NUMRU TAL- LOTT TAL- MANIFATTUR
20 ml (10 doses of 2 ml) 50 ml (25 doses of 2 ml)
20 ml (10 dożi ta ’ 2 ml) 50 ml (25 dożi ta ’ 2 ml)
i. m. injection
Injezzjoni fil- muskolu
Zero days.
Żmien ta ’ Tiżmim: xejn ġranet
EXP {month/ year} Once broached, use within 10 hours.
Jiskadi {xahar/ sena} Jekk infetaħ uża fi żmien 10 siegħat.
Porcilis AR-T DF suspension for injection for pigs
Porcilis AR- T DF suspensjoni għal injezzjoni għall- ħnieżer
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V Wim de Korverstraat 35 5831 AN BOXMEER L - OLANDA
Protein dO (non-toxic deletion derivative of Pasteurella multocida) dermonecrotic toxin)
Porcilis AR- T DF suspensjoni għal injezzjoni
≥ 5.9 log2 TN titre 1
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
1
Għall kull doża ta ’ 2 ml
≥ 4.2 log 2 Aggl. titre2
Protein dO (derivattiv mhux tossiku minn velenu dermo- nekrotiku ta ’ Pasteurella multocida > 5. 9Log2 TN tajter1 > 4. 2 log2 Aggl.
2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
Tajter1 Ċelloli inattivati ta ’ Bordatella bronchiseptica 1 Tajter medju li nnewtralizza l- velenu wara vaċċinazjoni ripetuta ta ’ nofs doża fil- fniek.
Adjuvant Per dose of 2 ml
2 Tajter ta ’ agglutinazjoni medju wara vaċċinazjoni waħda ta ’ nofs doża fil- fniek
Preservatives Per dose of 2 ml max 1.0 mg free formaldehyde.
Preservativi Għal kull doża ta ’ 2 ml Massimu ta ’ milligramma formalina fl- istat liberu
Reduced activity and lack of appetite in 10-20%
Majjali trattati wrew żieda medja ta ’ 1. 5o Ċ fit- temperatura tal- ġisem, f’ xi majjali kien hemm żieda anke sa 3oĊ, fil- ġurnata tal- vaċċinazzjoni jew l- għada.
The vaccine should preferably be administered just behind the ear.
Doża waħda ta ’ 2 ml għandha tiġi njettata intramuskularment lil majjali minn 18 il- ġimgħa l- fuq preferibilment wara l- widna.
Vaccination scheme:
Skeda tal- vaċċinazzjoni:
Basic vaccination: inject one dose per pig, followed by a second injection 4 weeks after the first injection.
Injetta doża waħda ghal kull majjala, b’ doża oħra erba ’ ġimgħat wara.
- Before using the vaccine allow it to reach room temperature (15°C - 25°C).
Qabel ma tuża l - vaċċin ħalliha tilħaq it- temperatura tal- kamra (15oĊ – 25oĊ).
- Shake vigorously before use and at intervals during use.
Ħawwad sewwa qabel u waqt li tuża.
- Avoid introduction of contamination.
Evita li tikkontamina.
- Vaccinate only healthy animals.
Laqqam biss animali f’ saħħithom
Store in a refrigerator (2 °C – 8 °C).
Aħżen f' temperatura ta '2°Ċ – 8°Ċ.
Keep the container in the outer carton.
Żomm il- kontenitur fil- kaxxa ta ’ barra.
Shelf-life after first opening the container:
Tużax wara d- data tal- iskadenza fuq it- tikketta Żmien li l- prodott jibqa 'tajjeb wara li jinfetaħ:
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.
Għalhekk wieħed m’ għandux ilaqqam b’ vaċċin ieħor fi żmien ħmistax qabel jew wara li jintuża dan il- prodott.
16/ 17 Do not mix with any other veterinary medicinal products.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
F’ każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'nformazzjoni li jkun fih ġewwa.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'Porcilis Pesti huwa pprojbit jew jista jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minhabba l- politika nazzjonali tagħhom dwar is- sahha tal- annimali.
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must consult the relevant Member State’ s Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża dan il - prodott għandu jikkonsulta mal- awtorita Kompetenti tal- Pajjiż Membru dwar il- programmi ta 'tilqim kurrenti qabel jimporta, jbiegħ, jissupplixxi jew juża.
02/ 2006
2/ 2006
Dermonecrotic toxin producing Pasteurella multocida is the pathogen responsible for turbinate atrophy in progressive atrophic rhinitis.
Pasteurella multocida li tipproduċi velenu dermo- nekrotiku huwa l- patoġenu li responsabbli ġħall - qerda ta ’ passaġġi fl- imnifsejn f’ rinite atrofika progressiva.
The vaccine contains a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Il - vaċċin fih derivattiv rikombinant mhux tossiku tal - velenu tal- Pasteurella multocida u ċelloli inattivati tal - Bordetella bronchiseptica.
The immunogens are incorporated in an adjuvant based on dl-α -tocopherol.
L- immunoġeni huma nkorporati fl- adjuvant bbażat fuq dl- alpha – tocopherol.
For animal treatment only.
Għat- Trattament tal- annimali biss.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasal għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ iktar informazzjoni dwar il- kundizzjoni medika jew dwar il- kura tal- annimali tiegħek ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar - rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Porcilis PCV?
X’ inhu Porcilis PCV?
Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection.
Porcilis PCV huwa vaċċin għal użu fil- ħnieżer, li hu disponibbli f’ emulsjoni injettabbli.
It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Fih proteina (antiġene) mill- virus taċ- ċirkovirus tal- ħnieżer tat- tip 2 (PCV2).
The vaccine does not contain any live PCV2.
Il- vaċċin ma fih ebda PCV2 ħaj.
What is Porcilis PCV used for?
Għal xiex jintuża Porcilis PCV?
Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection.
Porcilis PCV jintuża biex ilaqqam ħnieżer li jkollhom età ta ’ tlett ijiem jew aktar kontra infezzjoni bil- PCV2.
This helps to reduce the amount of virus in the animal’ s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Dan jgħin biex jitnaqqas l- ammont ta ’ virus fid- demm tal- annimal u fit - tessuti linfojde u biex inaqqas it- telf fil- piż assoċjat mal- infezzjoni bil- PCV2 li sseħħ matul il - perjodu tat- tismin.
The vaccine is given by injection into a muscle in the neck, in the area behind the ear.
Il- vaċċin jingħata b’ injezzjoni fil- muskolu tal- għonq, fil- parti ta ’ wara l- widna.
Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.
Il- protezzjoni kontra PCV2 tibda fi żmien ġimagħtejn wara l- injezzjoni u ddum applikabbli għal 22 ġimgħa.
How does Porcilis PCV work?
Kif jaħdem Porcilis PCV?
Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD).
Iċ- ċirkovirus tal- ħnieżer tat- tip 2 (PCV2) huwa magħruf li jikkawża firxa wiesgħa ta ’ sindromi fil- ħnieżer, flimkien magħrufin bħala mard relatat ma ’ ċirkovirus tal- ħnieżer tat- tip 2 (PCVD).
It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease.
Huwa ġeneralment aċċettat li infezzjoni b’ PCV2 hija essenzjali iżda mhux biżżejjed biex tikkawża marda.
PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Infezzjonijiet assoċjati ma ’ PCV2 jistgħu jinkludu sinjali kliniċi bħal telf fil- piż jew nuqqas ta ’ tkabbir, tkassir tal- linfonodi, diffikultà fit- teħid tan- nifs, dijarrea, ġilda pallida u suffejra (sfurija tal- ġilda).
Porcilis PCV is a vaccine.
Porcilis PCV huwa vaċċin.
Porcilis PCV contains small amounts of a protein from PCV2.
Porcilis PCV fih ammonti żgħar ta ’ proteina minn PCV2.
When a pig is given the vaccine, the pig’ s immune system recognises the protein as ‘ foreign’ and reacts by building up an active immune response.
Meta ħanżir jingħata vaċċin, is- sistema immunitarja tal- ħanżir tagħraf il - proteina bħala ‘ barranija ’ u tirreaġixxi billi tibni rispons immunitarju attiv.
Through this the immune system will be able to react more quickly when it is exposed to the virus.
Permezz ta ’ dan, is- sistema immunitarja tkun kapaċi tirreaġġixxi aktar malajr meta tkun esposta għall- virus.
This active immune response helps to protect the pig against the disease caused by this virus.
Dan ir- rispons immunitarju attiv jgħin jipproteġi lill- ħanżir kontra l- mard ikkawżat minn dan il- virus.
Reproduction is authorised provided the source is acknowledged monitored included weight gain, mortality as well as faecal and nasal shedding.
Porcilis PCV ġie studjat fuq ħnieżer f’ għadd ta ’ provi.
The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.
Dawn l- istudji twettqu f’ kundizzjonijiet ta ’ laboratorju kif ukoll f’ kundizzjonijiet ta ’ trobbija tipiċi rappreżentattivi ta ’ sistemi ta ’ produzzjoni tal- ħnieżer differenti.
What benefit has Porcilis PCV shown during the studies?
Liema benefiċċju wera Porcilis PCV waqt l- istudji mwettqa?
The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal’ s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Il- provi wrew li l- vaċċinazzjoni tal- ħnieżer b’ Porcilis PCV tgħin biex jitnaqqas l- ammont ta ’ virus fid- demm tal- annimal u fit- tessuti linfojdi u biex jitnaqqas it- telf fil- piż assoċjat mal - infezzjoni bil- PCV2 li sseħħ matul il- perjodu tat- tismin.
What is the risk associated with Porcilis PCV?
X’ inhu r- riskju assoċjat ma ’ Porcilis PCV?
In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Fil- ħnieżer, jistgħu jiżviluppaw reazzjonijiet lokalizzati u tranżitorji wara l- vaċċinazzjoni prinċipalment fil- forma ta ’ nefħa iebsa, sħuna u xi kultant b’ uġigħ (dijametru sa 10 cm).
These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Dawn ir- reazzjonijiet jgħibu waħidhom wara perjodu ta ’ madwar 14- 21 jum mingħajr ebda konsegwenza maġġuri fuq l- istatus ġenerali tas- saħħa tal- annimali.
Immediate systemic hypersensitivity- like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/ or excitation, which normally resolve within minutes without requiring treatment.
Eżatt wara l- vaċċinazzjoni jistgħu jseħħu reazzjonijiet ta ’ ipersensittività ta ’ natura sistemika b’ sintomi newroloġiċi minuri, bħal rogħda u/ jew eċċitament, li normalment jiġu solvuti wara ftit minuti u ma jeħtiġu l- ebda trattament.
A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
Żieda tranżitorja fit- temperatura tal- ġisem, li normalment ma tkunx iktar minn 1°C, tista ’ sseħħ sa jumejn wara l- vaċċinazzjoni.
Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Kultant, tista ’ sseħħ żieda fit - temperatura tar- rektum sa 2. 5 °C li ddum inqas minn 24 siegħa.
Some piglets may be depressed and show a reduced feed intake for up to 5 days.
Xi driefeġ jistgħu jħossuhom imdejqin u juru nuqqas ta ’ aptit għal mhux aktar minn 5 ijiem.
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Il- vaċċinazzjoni tista ’ twassal għal indeboliment temporanju fir- rata tat- tkabbir fil- perjodu eżattament wara l- għoti tal - vaċċin.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li għandhom jittieħdu mill- persuna li tagħti l- prodott mediċinali jew li tiġi f’ kuntatt mal- annimal?
Porcilis PCV contains mineral oil.
Porcilis PCV 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/ injezzjoni personali tista ’ tirriżulta f’ uġigħ gravi u f’ nefħa, b’ mod partikolari jekk din tiġi injettata f’ ġogi jew f’ xi saba ’, u, f’ każijiet rari tista ’ tirriżulta fit- telf tas- saba ’ milqut jekk ma tingħatax attenzjoni medika minnufih.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi injettat aċċidentalment b’ dan il- prodott, itlob parir mediku minnufih anke jekk ammont żgħir ħafna biss jiġi injettat u ħu miegħek il- fuljett ta ’ tagħrif.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ jibqa ’ hemm għal aktar minn 12- il siegħa wara eżami mediku, itlob parir mediku mill- ġdid.
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
X’ inhu ż- żmien permess qabel l- annimal ikun jista ’ jinqatel u l- laħam użat għall- konsum mill - bniedem (perjodu ta ’ rtirar)?
The withdrawal period is zero days.
Il- perjodu ta ’ rtirar huwa ta ’ żero jiem.
Why has Porcilis PCV been approved?
Għaliex ġie approvat Porcilis PCV?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Porcilis PCV huma ogħla mir- riskji għall- immunizzazzjoni attiva ta ’ ħnieżer, ta ’ età aktar minn tlett ijiem, kontra PCV2, u rrakkomanda li Porcilis PCV jingħata awtorizzazzjoni għat - tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r- riskju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR
Other information about Porcilis PCV:
Informazzjoni oħra dwar Porcilis PCV:
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida fl- Unjoni Ewropea kollha għal Porcilis PCV lil Intervet International BV nhar il- 12/ 01/ 2009.
Information on the prescription status of this product may be found on the outer package.
Informazzjoni fuq l- istatus tar- riċetta veterinarja ta ’ dan il- prodott hija disponibbli fuq il - pakkett ta ’ barra.
This summary was last updated in January 2009.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EMEA Number
Numru EU
Invented Name
Invented name
Target species
Speċi li fuqhom jintuża l - prodott
Route of administration
Metodu ta’ amministr azzjoni
Packaging
Ipakkjar
Package size
Daqs tal - pakett
Withdrawal period
Perjodu ta’ tiżmim
EU/ 2/ 08/ 091/ 001
EU/ 2/ 08/ 091/ 001 Porcilis PCV ≥4. 5 log2
≥ 4.5 log 2 ELISA units
Emulsjoni għal - Ħnieżer injezzjoni
Vial (PET)
Fjala (PET)
1 vial
1 fjala
EU/ 2/ 08/ 091/ 002
EU/ 2/ 08/ 091/ 002 Porcilis PCV ≥4. 5 log2
50 ml
50ml
EU/ 2/ 08/ 091/ 003
EU/ 2/ 08/ 091/ 003 Porcilis PCV ≥4. 5 log2
EU/ 2/ 08/ 091/ 004
EU/ 2/ 08/ 091/ 004 Porcilis PCV ≥4. 5 log2
200 ml
200ml
EU/ 2/ 08/ 091/ 005
EU/ 2/ 08/ 091/ 005 Porcilis PCV ≥4. 5 log2
EU/ 2/ 08/ 091/ 006
EU/ 2/ 08/ 091/ 006 Porcilis PCV ≥4. 5 log2
10 vials
10 fjala
EU/ 2/ 08/ 091/ 007
EU/ 2/ 08/ 091/ 007 Porcilis PCV ≥4. 5 log2
EU/ 2/ 08/ 091/ 008
EU/ 2/ 08/ 091/ 008 Porcilis PCV ≥4. 5 log2
EU/ 2/ 08/ 091/ 009
EU/ 2/ 08/ 091/ 009 Porcilis PCV ≥4. 5 log2
EU/ 2/ 08/ 091/ 010
EU/ 2/ 08/ 091/ 010 Porcilis PCV ≥4. 5 log2
Porcilis PCV emulsion for injection for pigs
Porcilis PCV emulsjoni għal injezzjoni għal- ħnieżer
Each dose of 2 ml contains:
Kull doża ta ’ 2 ml:
Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units*
Subunit tal- antiġen ta ’ Circovirus tal - ħnieżer tip 2 ORF2: tal- anqas 4. 5 log2 ELISA units *
* Antibody titre obtained according to the in vivo potency test in chickens.
* Tajter tal- antikorpi miksub minn testijiet ta’ potenza in vivo fil- flieles.
Adjuvants Dl-α -tocopheryl acetate
D1- α- tocopheryl acetate 25mg Paraffina likwida ħafifa 346mg
Polysorbate 80
Polisorbejt 80
For a full list of excipients, see section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti mhux attivi, ara sezzjoni 6. 1.
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period
Għal- immunizzazzjoni attiva tal- ħnieżer biex jitnaqqas l- ammont ta ’ virus fid- demm u tessut limfatiku, u biex jitnaqqas it- telf ta ’ piż assoċjat mal- infezzjoni bil- PCV2 waqt iż- żmien tas- simna.
Onset of immunity:
Bidu tal- immunita`:
2 weeks
2 ġimġħat
Duration of immunity:
Kemm iddum l- immunita`:
22 weeks
22 ġimġħat
From the data provided, it can be concluded that a full dose regimen of vaccination breaks through medium to high levels of maternally derived antibodies in piglets.
Mill- informazzjoni provduta, wieħed jista ’ jikkonkludi li reġimen ta ’ dożi sħaħ ta ’ vaċċinazzjoni jinduċi livelli medji sa għoljin ta ’ antokorpi li ġejjin mil- omm, fil- qżieqeż.
No data are available on the use of the vaccine in breeding boars.
M’ hemmx informazzjoni dwar l- użu tat- tilqima fi fħula tat- tgħammir.
2/ 19 4.5 Special precautions for use
2/ 19 4. 5 Prekawzjonijiet Speċjali għall- Użu
Vaccinate only healthy animals.
Laqqam biss annimali b`saħħithom
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 jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa specjalment jekk tinjetta f' ġog jew subgħa u f' każijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ idum għal aktar minn tnax – il siegħa, wara l- eżami mediku, erġa 'kellem lit- tabib.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata MAL- EWWEL u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata l- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa jew it- tendin tal- muskolu.
Transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Wara l- vaċċinazzjoni, rejazzjonijiet lokalizzati li jgħaddu, jistgħu iffiġġu fil- post tal- injezzjoni b’ mod komuni taħt forma ta ’ nefħa iebsa, sħuna u xi drabi li tkun tuġgħa (dijametru sa 10cm).
These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Dawn ir - rejazzjonijiet jgħaddu waħidhom fuq perjodu ta ’ madwar 14- 21 il- ġurnata mingħajr ebda konsegwenzi serji fuq is- saħħa ġenerali tal- annimal.
Immediate systemic hypersensitivity-like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/ or excitation, which normally resolve within minutes without requiring treatment.
Rejazzjonijiet sistemiċi immedjati ta’ ipersensittivita` jistgħu ifiġġu wara l- vaċċinazzjoni, li jwasslu għall- sintomi newroloġiċi minuri bħal tregħid u/ jew eċċitazzjoni, li normalment jgħaddu fi ftit minuti mingħajr bżonn ta’ trattament.
A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
It- temperatura tista togħla ftit imma ma taqbiżx il - 10 C, sa jumejn wara l- vaċċinazzjoni.
Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Xi drabi, żieda fit- temperatura rettali sa 2. 50C, imma li ma dumx aktar minn 24 siegħa tista s- seħħ.
Some piglets may be depressed and show a reduced feed intake for up to 5 days.
Xi qżieqes jistgħu jkunu dipressi u jieklu anqas, sa 5 tijiem.
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Il- vaċċinazzjoni tista twassal fi tnaqqis tar- rata ta ’ tkabbir fil- pejodu immedjat ta ’ wara l - vaccinazzjoni.
Do not use during pregnancy and lactation.
L- użu tiegħu m' huwiex rakkomandat waqt it- tqala jew fi żmien il- ħalib
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor mediċinali veterinarju.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Għalhekk, id- deċiżjoni li dan il- vaċċin jintuża qabel jew wara kwalunkwe prodott mediċinali veterinarju għandha ssir każ b’ każ.
Before using the vaccine, allow it to reach room temperature and shake well before use.
Qabel tużgħa t- tilqima, ħalliha tilħaq it- temperatura tal- kamra u ħawwad sew qabel l- użu.
Avoid multiple vial broaching.
Evita` li tiftaħ aktar minn fjal wieħed fl- istess ħin.
Use sterile syringes and needles.
Uża siringi u labar sterilizzati.
Avoid introduction of contamination.
Evita` li tinroduċi kontaminazzjoni.
Avoid use of vaccination equipment with rubber parts.
Evita` l- użu ta ’ apparat tal- vaċċinazzjoni li għandu partijiet tal- lastiku.
3/ 19 Vaccination Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:
3/ 19 Vaċċinazzjoni Doża waħda ta ’ 2 millilitri għandha tiġi njettata intramuskularment fl- għonq, fin- naħa ta ’ wara l - widna, skont l- iskema li ġejja:
The first injection (2 ml) can be given from an age of 3 days, with the second injection (2 ml) 2-3 weeks later.
L- ewwel injezzjoni (2ml) tista ’ tingħata mill- eta` ta ’ 3 ijiem, u t- tieni injezzjoni (2ml) 2- 3 ġimgħat wara.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed.
Wara l- amministrazzjoni ta ’ doża doppja tal- vaċċin l- ebda effett mhux mixtieq, apparti dawk imsemija taħt “ effeti mhux nixtieqa ” (sezzjoni 4. 6) ma ġie osservat.
Inactivated Porcine circovirus vaccine.
Vaċċin inattivat kontra l- virus tal- circovirus fil- ħnieżer
Vaccine to stimulate active immunity against Porcine circovirus type 2
Vaċċin biex jistimula immunita` attiva kontra l- virus Porcine circovirus tip 2.
Polysorbate 80 Simethicon Water for injections
Polisorbejt 80 Simetikon Ilma għal injezzjoni
2 years Shelf life after first opening the immediate packaging:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sentejn Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
8 hours.
8 siegħat
Protect from light.
Aħżen fil- friġġ (2°C – 8°C) Tifriżax Ipproteġi mid- dawl
Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.
Kaxxi tal- kartun li fihom, 1 jew 10 fjali tal- PET ta ’ 20, 50, 100, 200 jew 500 ml.
Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
Il- fjali huma magħluqa b ’ tapp tal- gomma u ssiġillati b ’ kappa tal - aluminjum b’ kodiċi fuqha.
4/ 19 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
4/ 19 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
5/ 19 ANNEX II
5/ 19 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Intervet International BV Wim de Korverstraat 35 5831 AN Boxmeer Olanda
2377/ 90 in accordance with the following table:
Il- kostitjuwenti ta ’ Porcilis PCV indikati hawn taħt huma inklużi fl- Anness II tar- Regolament tal - Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
Pharmacologically active substances
Sustanzi farmakoloġikament attivai
Animal species
Speċi tal- annimal
Other provisions
Kull speċi għall- ikel
Light liquid paraffin Dl-alpha-tocopherol acetate
D1- alpha- tocopherol acetate
All food producing species All food producing species
Kull speċi għall- ikel
Polysorbate 80 (Polyoxyethylene sorbitan monooleate)
Polisorbejt 80 (Polyoxyethylene sorbitan monooleate)
Simethicone (dimethicone)
Simetikon (dimethicone)
7/ 19 ANNEX III
7/ 19 ANNESS III
9/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Porcilis PCV emulsion for injection for pigs
Porcilis PCV emulsjoni għall- injezzjoni għall- ħnieżer
Per dose of 2 ml:
Għall kull doża ta ’ 2 ml:
Porcine Circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units 25 mg dl- α -tocopheryl acetate 346 mg light liquid paraffin Polysorbate 80
Circovirus tal - ħnieżer tip 2 ORF2 subunit tal- antiġen: tal- anqas 4. 5 log2 ELISA units D1- α- tocopheryl acetate 25mg Paraffina likwida ħafifa 346mg Polisorbejt 80
1 vial of 10,25,50,100,250 doses 10 vials of 10,25,50,100,250 doses
1 fjala ta ’ 10, 25, 50, 100, 250 doża 10 fjali ta ’ 10, 25, 50, 100, 250 doza
Vaccine against Porcine circovirus type 2
Vaċċin kontra l - Porcine circovirus tip 2
Intramuscular use Read the package leaflet before use
Għall- użu intramuskolari Aqra l- fuljett ta’ tagħrif fil- pakett qabel l- użu
Withdrawal period: zero days
Żmien ta 'Tiżmim: xejn ġranet
Shake
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża' Ħallat sewwa qabel tuża.
EXP {month/ year} Once broached, use within 8 hours
Jiskadi {xahar / sena} La darba jinfetaħ uża fi żmien 8 sigħat
Do not freeze.
Aħżen bejn 2°C – 8°C Tifriżax, ipproteġi mid- dawl
Read the package leaflet before use.
Aqra l- fuljett ta’ tagħrif fil- pakett qabel l- użu
For animal treatment only – to be supplied only on veterinary prescription
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni veterinarja.
12/ 19 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE {100, 200, 500 ml bottles}
12/ 19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA {100, 200, 500 ml fliexken}
PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units dl-α -tocopheryl acetate light liquid paraffin Polysorbate 80
Circovirus tal - ħnieżer tip 2 ORF2 subunit tal- antiġen: tal- anqas 4. 5 log2 ELISA units D1- α- tocopheryl acetate Paraffina likwida rqiqa Polisorbejt 80
1 vial of 100, 200, 500 ml (50,100,250 doses) 10 vials of 100, 200, 500 ml (50,100,250 doses)
1 fjala ta ’ 100, 200, 500ml (50, 100, 250 doża) 10 fjali ta ’ 100, 200, 500ml (50, 100, 250 doża)
Vaccine against Porcine circovirus type 2
Vaċċin kontra l- Porcine circovirus tip 2
Intramuscular use Read the package leaflet before use
Għall- użu intramoskulari Aqra l- fuljett ta’ tagħrif fil- pakett qabel l- użu
Shake well before use.
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża' Ħawwad sewwa qabel tuża.
Intervet International BV 5831 AN Boxmeer The Netherlands
5831 AN Boxmeer Olanda
14/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {20,50 ml vial}
14/ 19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR {fjali ta ’ 20, 50 ml}
Per dose:
Kull doża:
PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units
PCV2 ORF2 subunits tal- antiġen: ≥4. 5 log2 ELISA units
20, 50ml (10, 25 doses)
20, 50 ml (10, 25 dożi)
Shake well before use
Ħawwad sewwa qabel tuża
Withdrawal period: zero days
Żmien ta ’ Tiżmim: xejn ġranet
16/ 19 PACKAGE LEAFLET FOR:
16/ 19 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
PORCILIS PCV emulsion for injection for pigs
PORCILIS PCV Emulsjoni għal- injezzjoni għall- ħnieżer
Marketing authorisation holder and manufacturer:
Sid l- Awtorizzazzjoni tal- Kummerċ u l- manifattur:
Porcilis PCV emulsion for injection for pigs
Porcilis PCV emulsjoni għal injezzjoni għall- ħnieżer
Per dose of 2 ml:
Kull doża ta ’ 2 ml:
Porcine Circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units as determined in the in vivo potency test in chickens Adjuvants:
Sustanzi mhux attivi:
25 mg dl-α -tocopheryl acetate 346 mg light liquid paraffin Polysorbate 80
D1- α- tocopheryl acetate 25mg Paraffina likwida ħafifa 346mg Polisorbejt 80
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Għal- immunizzazzjoni attiva tal- ħnieżer biex jitnaqqas l- ammont ta ’ virus fid- demm u tessut limfatiku, u biex jitnaqqas it- telf ta’ piż assoċjat mal- infezzjoni bil- PCV2 waqt iż- żmien tas- simna.
2 weeks Immunity will last:
Kemm iddum l- immunita`:
CONTRAINDICATIONS
KONTRADIZZJONIJIET
This will normally resolve within minutes without requiring treatment.
Rejazzjonijiet sistemiċi immedjati ta’ ipersensittivita` jistgħu
A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
17/ 19 ifiġġu wara l- vaċċinazzjoni, li jwasslu għall- sintomi newroloġiċi minuri bħal rogħda u/ jew eċċitazzjoni, li normalment jgħaddu fi ftit minuti mingħajr bżonn ta ’ trattament.
Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
It- temperatura tista ’ togħla ftit imma ma taqbiżx il - 10 C, sa jumejn wara l- vaċċinazzjoni.
Some piglets may be depressed and
Xi drabi, żieda fit- temperatura rettali sa 2. 50C, imma li ma dumx aktar minn 24 siegħa tista s- seħħ.
17/ 19 show a reduced feed intake for up to 5 days.
Xi qżieqeż jistgħu jkunu dipressi u jnaqqsu mill- ikel, sa 5 t’ ijiem.
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Il- vaċċinazzjoni tista twassal fi tnaqqis tar- rata ta ’ tkabbir fil- pejodu immedjat ta ’ wara l - vaċċinazzjoni.
Administer one dose (2 ml), by intramuscular injection in the neck in the area behind the ear, according to the following schedule:
Doża waħda ta ’ 2 millilitri għandha tiġi njettata intramuskularment fl- għonq, fin- naħa ta ’ wara l - widna, skont l- iskema li ġejja:
The first injection (2ml) can be given from an age of 3 days, second injection (2 ml) 2-3 weeks later.
L- ewwel injezzjoni (2ml) tista ’ tingħata mill- eta` ta ’ 3 ijiem, u t- tieni injezzjoni (2ml) 2- 3 ġimgħat wara.