qanastek/EMEA-V3 huggingface dataset:
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Sid ta ’ l- Awtoriżżazzjoni tal- Kummerċ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
BLISTER / Tablets
FOLJA / Pilloli
NAME OF MARKETING AUTHORISATION HOLDER
ISEM TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
Pfizer (Logo)
Pfizer (Marka)
THE WORDS “FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
For animal treatment only.
Għal Trattament ta ’ l- Annimali Biss
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Cerenia 24 mg tablets for dogs Maropitant
Cerenia 24 mg pilloli għal klieb Maropitant
Each tablet contains 24 mg maropitant as maropitant citrate monohydrate.
Kull pillola fiha 24 mg maropitant bħala ċitrat monoidrat ta ’ maropitant.
21 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Cerenia 60 mg tablets for dogs
Cerenia 60 mg pilloli għal klieb
Each tablet contains 60 mg maropitant as maropitant citrate monohydrate.
Kull pillola fiha 60 mg maropitant bħala ċitrat monoidrat ta ’ maropitant.
24 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Cerenia 60 mg Maropitant
Cerenia 60 mg Maropitant
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Cerenia 160 mg tablets for dogs Maropitant
Cerenia 160 mg pilloli għal klieb Maropitant
Each tablet contains 160 mg maropitant as maropitant citrate monohydrate.
Kull pillola fiha 160 mg maropitant bħala ċitrat monoidrat ta ’ maropitant.
8 mg/kg bodyweight for motion sickness.
8 mg/ kg piż għal dardir tal- ivvjaġġar.
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARDBOARD CARTON / Solution for injection
KAXXA TAL- KARTUN / Soluzzjoni għal injezzjoni
Cerenia 10 mg/ml solution for injection for dogs
Cerenia 10 mg/ ml soluzzjoni għal injezzjoni għal klieb
Metacresol as preservative.
10 mg maropitant għal kull ml bħala ċitrat monoidrat ta ’ maropitant Metacresol bħala preservattiv.
Solution for injection
Soluzzjoni għal injezzjoni
1 mg/kg bodyweight
1 mg/ kg piż
EXP {month/year} Once broached, use by:…………..
JISKADI {xahar / sena} La darba jittaqqab it- tapp, uża sa:.........
For animal treatment only- to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika.
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Sid ta ’ l- Awtoriżżazzjoni tal- Kummerċ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
GLASS VIAL / Solution For Injection
KUNJETT TAL- ĦĠIEĠ / Soluzzjoni Għal Injezzjoni
Cerenia 10 mg / ml solution for injection for dogs
Cerenia 10 mg/ ml soluzzjoni għal injezzjoni għal klieb
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
EXP {month/year} Once broached, use within 28 days.
JISKADI {xahar / sena} La darba jittaqqab it- tapp, uża sa:.........
32 PACKAGE LEAFLET FOR:
32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Cerenia tablets for dogs
Cerenia pilloli għal klieb
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Sid l- Awtorizzazzjoni tal- Kummerċ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
Manufacturing Authorisation Holder Responsible for Batch Release Pfizer PGM 37530 Pocé sur Cisse France
Manifattur li jħalli l- konsenja tmur fis- suq Pfizer PGM 37530 Poce sur Cisse Franza
Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia 160 mg tablets for dogs
Cerenia 16 mg pilloli għal klieb Cerenia 24 mg pilloli għal klieb Cerenia 60 mg pilloli għal klieb Cerenia 160 mg pilloli għal klieb
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
The tablets also contain Sunset Yellow (E110) as a colourant The tablets are pale orange and have a score line on both sides allowing the tablet to be halved.
Il- pilloli huma oranġjo ċar u fihom linja għall- qsim fuq kull naħa biex il- pillola tkun tista ’ tinqasam fi tnejn.
On the obverse side, each half is marked with the letters “MPT” and figures denoting the quantity of maropitant.
Fuq in- naħa ta ’ quddiem, kull nofs hu immarkat bl- ittri “ MPT ” u numri li juru il kwantità ta ’ maropitant.
For the treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures.
Għat- trattament ta ’ remettar, flimkien ma ’ Cerenia Soluzzjoni Għal Injezzjoni u flimkien ma ’ miżuri oħra ta ’ għajnuna.
CONTRAINDICATIONS
KONTRA INDIKAZZJONIJIET
Administering Cerenia on a completely empty stomach may cause your dog to vomit.
Il- kelb tiegħek jista ’ jirremetti jekk Cerenia tiġi amministrata fuq stonku kompletament vojt.
Giving your dog a light meal or snack before administering the tablet could help preventing this effect.
Dan l - effett jista ’ jiġi evitat jekk tgħati xi ħaġa żgħira ta ’ l- ikel lill- kelb tieghek qabel tamministra l- pillola.
Prolonged fasting before administration should be avoided.
Nuqqas ta ’ ikel fit- tul qabel tingħata l- mediċina għandu jkun evitat.
Cerenia is not a sedative and some motion sick dogs may show nausea-like signs during travel such as salivation and lethargy.
Cerenia mhiex sedattiv u xi klieb milquta minn dardir tal- ivvjaġġar jistgħu juru sinjali ta ’ nawżja bħal salivazzjoni u telqa qawwija waqt il- vjaġġ.
These signs are temporary and should resolve when the journey ends.
Dawn is- sinjali jgħaddu u għandhom jitilqu kif jintemm il- vjaġġ.
For oral use
Għal użu orali
For Treatment and Prevention of Vomiting (except Motion Sickness)
Għat- trattament u l- Prevenzjoni ta ’ Remettar (mhux minn Dardir tal- Ivvjaġġar)
To treat and/or prevent vomiting except motion sickness, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
Għat- trattament u l- prevenzjoni ta ’ remettar, il- pilloli Cerenia għandhom jiġu amministrati darba kuljum f’ doża ta ’ 2 mg maropitant għal kull kg piż, b’ numru ta ’ pilloli kif jidher fit- tabella hawn taħt.
Cerenia can be used to treat vomiting either as tablets or as solution for injection once daily for up to five days.
Cerenia tista ’ tintuża għall- kura jew prevenzjoni ta ’ remettar sew bħala pilloli kif ukoll bħala soluzzjoni għal injezzjoni darba kuljum sa ħamest- ijiem.
For Prevention of Vomiting induced by Motion Sickness To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Għall- Prevenzjoni ta ’ Remettar li jkun ġej minn Dardir tal- Ivvjaġġar Għall- prevenzjoni ta ’ remettar li jkun ġej minn dardir tal- ivvjaġġar, il- pilloli Cerenia għandhom jiġu amministrati darba kuljum f’ doża ta ’ 8 mg maropitant għal kull kg piż, b’ numru ta ’ pilloli kif jidher fit- tabella hawn taħt.
34 Tablets should be administered at least one hour before starting the journey.
34 Il- pilloli għandhom jingħataw mill- anqas siegħa qabel ma jibda ’ il- vjaġġ.
In some individual dogs and when repeating the treatment, lower doses than recommended might be sufficient.
F’ xi klieb individwi u meta d- doża tkun ripetuta, dożi aktar baxxi minn dawk rikmandati jistgħu ikunu biżżejjed.
Prevention of motion sickness only
Prevenzjoni ta ’ Dardir tal- Ivvjaġġar
7.6 – 10.0 10.1 – 15.0 15.1 – 20.0 20.1 – 30.0 30.1 – 40.0 40.1 – 60.0
7. 6 – 10. 0 10. 1 – 15. 0 15. 1 – 20. 0
To remove a tablet from the blister the following sequence should be carried out; • Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol . • Find the pull-back notch (or cut) as shown by the arrow symbol. • Holding one side of the cut firmly, pull the other side towards the centre of the blister until the tablet is visible • Remove table from blister and administer as instructed.
Biex tneħħi pillola minn ġol- folja, is- sekwenza li ġejja għandha tiġi segwita: • L- ewwel itwi jew aqta ’ mal- perforazzjoni li hemm bejn il- pilloli kif juri s- simbolu ta ’ l- imqass. • Sib it- tarf li jinġibed lura (jew aqta ’) kif juri s- simbolu tal- vleġġa. • Waqt li żżomm naħa sew, iġbed in- naħa l- oħra lejn iċ- centru tal- folja sakemm il- pillola tidher. • Neħħi l- pillola mill- folja u amministra skond l- istruzzjonijiet.
No attempt should be made to remove the tablet by pushing it through the blister backing as this will damage both the tablet and blister.
M’ għandekx tipprova tneħħi l- pillola billi timbuttaha minn ġol- folja għax b’ hekk issir ħsara kemm lill- pillola kif ukoll lill- folja.
For motion sickness a light meal or snack before dosing is recommended, prolonged fasting before administration should be avoided.
Għal dardir tal- ivvjaġġar huwa rikmandat li tingħata xi ħaġa ħafifa ta ’ l- ikel qabel tingħata d- doża; nuqqas ta ’ ikel fit- tul qabel tingħata l- mediċina għandu jkun evitat.
Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of the effect.
Pilloli Cerenia m’ għandhomx jingħataw mgerba jew miksija bl- ikel billi dan iwassal biex il- pillola ddum aktar biex tinħall u b’ hekk idum ma jkollha effett.
SPECIAL STORAGE CONDITIONS
PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ kondizzjonijiet ta ’ ħażna speċjali.
Half tablets should be stored for a maximum of two days after removal from the blister.
Nofs pilloli għandhom jinżammu l- aktar sa jumejn wara li jkunu tneħħew mill- folja.
Half-tablets should be returned to the opened blister and kept within the cardboard outer.
Nofs pilloli għandhom jitpoġġew lura fil- folja miftuħa u miżmuma fil- kaxxa ta ’ barra tal- kartun.
Do not use after the expiry date, which is mentioned on the blister after EXP.
Tużax wara d- data tal- iskadenza imniżżla wara JISKADI fuq il- folja.
Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated.
Remettar jista ’ jkun ġej minn kundizzjonijiet serji u li jiddebolixxu ħafna u l- kawża għandha tiġi nvestigata.
Products such as Cerenia should be used in conjunction with other supportive measures such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Prodotti bħal Cerenia għandhom jintużaw flimkien ma ’ miżuri oħra ta ’ għajnuna bħal kontroll tad- dieta u fluid replacement therapy kif rikmandat mit- tabib veterinarju tiegħek.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver disease.
Maropitant jiġi mmetaboliżat fil- fwied u għalhekk għandu jintuża bil- għaqal f’ pazjenti b’ mard fil- fwied.
The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi klieb ta ’ anqas minn 16- il ġimgħa u fi klieb tqal jew li qed ireddgħu.
The responsible veterinarian should make a benefit-risk assessment before using Cerenia in dogs under 16 weeks of age or in pregnant or lactating bitches.
Il- veterinarju responsabbli għandu jagħmel valutazzjoni tal - benefiċċju u r- riskju qabel juża Cerenia fi klieb ta ’ anqas minn 16- il ġimgħa jew fi klieb tqal jew li qed ireddgħu.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been overdosed in excess of 20 mg/kg.
Meta l- prodott ingħata f’ dożi ogħla minn 20 mg/ kg, ġew osservati sinjali kliniċi li jinkludu remettar ma ’ l- ewwel amministrazzjoni, salivazzjoni eċċessiva u ħmieġ immerraq.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician..
F’ każ li tibilgħu b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il - fuljett ta 'informazzjoni li jkun fih il- pakkett jew it- tikketta.
DATE ON WHICH PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL - PAKKETT
Cerenia tablets are supplied in blister packs with four tablets per pack.
Pilloli Cerenia jiġu f’ folji b’ erba ’ pilloli f’ kull pakkett.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- awtorizzazzjoni tal- kummerċ.
38 PACKAGE LEAFLET FOR:
38 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Manufacturing Authorisation Holder Responsible For Batch Release Pfizer PGM 37530 Pocé sur Cisse France
Manifattur li jħalli l- konsenja tmur fis- suq Pfizer PGM 37530 Poce sur Cisse Franza
Cerenia 10 mg/ml solution for injection for Dogs Maropitant
Cerenia 10 mg/ ml soluzzjoni għal injezzjoni għal Klieb Maropitant
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a clear, colourless to light yellow solution It also contains metacresol (as preservative).
Fiha wkoll metacresol (bħala preservattiv).
INDICATIONS
INDIKAZZJONI (JIET)
For the treatment of vomiting, in combination with other veterinary and supportive measures.
Għat- trattament ta ’ remettar, flimkien ma ’ miżuri oħra ta ’ għajnuna.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
For subcutaneous use
Użu għal taħt il- ġilda.
Treatment may be repeated for up to five consecutive days.
Il- kura tista ’ tiġi ripetuta sa ħamest- ijiem wara xulxin.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to 5 days.
Cerenia tista ’ tintuża għall- kura jew prevenzjoni ta ’ remettar sew bħala pilloli kif ukoll bħala soluzzjoni għal injezzjoni darba kuljum sa ħamest- ijiem.
SPECIAL STORAGE CONDITIONS
11 PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
Once opened, the vial should be used within 28 days.
Ladarba jinfetaħ, il- kunjett għandu jintuża fi żmien 28 ġurnata.
Do not use after the expiry date, which is mentioned on the label of the vial after EXP.
Tużax wara d- data tal- iskadenza imniżżla wara JISKADI fuq it- tiketta tal- kunjett.
Cerenia should be used with caution in animals suffering from or with predisposition for heart diseases.
Cerenia għandha tintuża bil- għaqal f’ annimali li jbatu jew li għandhom tendenza b’ mard tal- qalb.
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 b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun fih il- pakkett jew it- tikketta.
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
F’ każ li b’ mod aċċidentali jintlaqtu l- għajnejn, laħlaħ l- għajnejn b’ ħafna ilma u fittex attenzjoni medika.
Cerenia must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
Cerenia m’ għandhiex titħallat ma ’ prodotti mediċinali veterinarji oħra fl- istess siringa billi l - kompatibilità tagħha ma ’ prodotti oħra ma ġietx ittestjata.
40 Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Cerenia m’ għandhiex tintuża flimkien ma ’ Ca- channel antagonists billi maropitant għandu affinità għal Ca- channels.
Cerenia 10 mg per ml solution for injection for dogs is available in 20 ml amber glass vials.
Cerenia 10 mg għal kull ml soluzzjoni għal injezzjoni fil- klieb tiġi f’ kunjetti tal- ħġieġ kannella ta ’ 20 ml.
Each cardboard box contains 1 vial.
Kull kaxxa tal- kartun fiha kunjett wieħed.
France Pfizer Téléphone: +33 (0)1 58 07 46 00
41 France Pfizer Téléphone: +33 (0) 1 58 07 46 00
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropew.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni jew it- trattament mediku ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar informazzjoni fuq il- bażi tar - rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Circovac?
X’ inhu Circovac?
Circovac is a vaccine for use in pigs.
Cirovac huwa vaċċin għal użu fuq il- ħnieżer.
It comes in two vials, one containing a suspension and the other containing an emulsion, and these need to be mixed before injection.
Huwa jiġi f’ żewġ kunjetti, wieħed fih sospensjoni u l - ieħor fih emulsjoni, u dawn jeħtieġ li jitħalltu qabel l- injezzjoni.
Circovac contains an inactivated porcine circovirus type 2 (PCV2) virus strain. ‘ Inactivated’ means that the virus has been killed so that it can no longer cause disease.
Cirovac fih razza ta ’ vajrus Ċirkovirus tal- ħnieżer tat- tip 2 mhux attivat (PCV2). ‘ Mhux attivat ’ ifisser li l- vajrus ġie maqtul sabiex ma jkunx jista ’ jibqa jikkaġuna mard.
What is Circovac used for?
Għal x’ hiex jintuża Circovac?
Circovac is used to reduce the changes in and damage to lymphoid tissues associated with PCV2 infection in piglets and to help reduce the overall deaths in piglets connected with this infection.
Circovac jintuża biex inaqqas il- bidliet fi u l- ħsara lit- tessuti limfojde assoċjati ma ’ infezzjoni b’ PCV2 fil- qżieqeż u biex jgħin inaqqas l- imwiet totali relatati ma ’ din l- infezzjoni fil- qżieqeż.
The vaccine is given to female pigs before and/ or during pregnancy.
Il- vaċċin jingħata lil ħnieżer nisa qabel u/ jew waqt it- tqala.
Their piglets then become immunised when they drink the colostrum (first milk) from their vaccinated mothers.
Imbagħad, il- qżieqeż tagħhom jirċievu l- immunità meta jixorbu l- kolostrum (l- ewwel ħalib) minn ommijiethom imlaqqma.
Circovac is given by deep intramuscular (into a muscle) injection.
Circovac jingħata permezz ta ’ injezzjoni intramuskolari (ġol- muskolu) fil- fond.
The number of injections needed varies according to the type of female pig being treated: gilts (female pigs that have not yet had piglets) need to receive three injections; sows (female pigs that have had piglets before) need to receive two injections; and sows that have been vaccinated before need only one injection.
In- numru ta ’ injezzjonijiet meħtieġa jvarja skond it- tip ta ’ ħanżira ttrattata: ħnieżer nisa żgħar (ħnieżer nisa li għad ma kellhomx qżieqeż) jeħtieġ li jirċievu tlett injezzjonijiet; majjaliet (ħnieżer nisa li diġà kellhom il - qżieqeż) jeħtieġu żewġ injezzjonijiet; u majjaliet li kienu diġà mlaqqma jeħtieġu injezzjoni waħda biss.
The timing of the injection is adjusted according to the dates of mating and farrowing (giving birth).
Il- ħin ta ’ l- injezzjoni huwa aġġustat skond id- dati tat- tgħammir u tat- tferrigħ (tal- ħlas).
In all cases the last dose (and only dose, in case of re-vaccination) is given at least two weeks before the expected date of farrowing.
Fil - każijiet kollha l- aħħar doża (u l- unika doża, fil- każ ta ’ tilqim mill- ġdid) tingħata ta ’ l- anqas ġimagħtejn qabel id- data tat- tferrigħ mistennija.
How does Circovac work?
Kif jaħdem Circovac?
Porcine circovirus type 2 (PCV2), is known to infect, and cause a wide variety of clinical signs and syndromes in pigs, some of which may be caused by PCV2 in combination with other agents.
Ċirkovirus tal- ħnieżer tat- tip 2 (PCV2), huwa magħruf li jinfetta, u jikkaġuna firxa wiesgħa ’ ta ’ sinjali u sindromi kliniċi fil- ħnieżer, xi wħud li jistgħu jkunu kkaġunati b’ PCV2 f’ kumbinazzjoni ma ’ aġenti oħra.
In piglets, PCV2 associated infections may include symptoms such as weight loss (or failure to grow), enlarged lymph nodes, difficulties in breathing, and, less commonly, diarrhoea, pale skin and jaundice (yellowing of the skin).
Fil- qżieqeż, infezzjonijiet assoċjati ma ’ PCV2 jistgħu jinkludu sintomi bħalma huma telf fil- piż (jew nuqqas ta ’ żvilupp), glandoli limfatiċi minfuħin, diffikulatajiet fit- teħid tan- nifs, u, b’ mod inqas komuni, dijarea, ġilda pallida u suffejra (sfurija tal- ġilda).
Circovac contains inactivated PCV2.
Cirovac fih PCV2 mhux attivat.
When the gilt or sow is injected, the pig’ s immune system recognises the inactivated virus as ‘ foreign’ and reacts to this by producing antibodies to destroy it.
Meta l- ħanżira tiġi injetatta, is- sistema immunitarja tal- ħanżira tagħraf lill- vajrus mhux attivat bħala ‘ barrani ’ u tirreaġixxi għal dan billi tipproduċi antikorpi biex teqirdu.
These antibodies are transferred from the mother to the piglets through the colostrum, and they help the piglets to fight the PCV2 virus if they become exposed to it after they are born.
Dawn l- antikorpi huma trasferiti mill- omm lill- qżieqeż minn ġol- kolostrum, u huma jgħinu lill - qżieqeż biex jiġġieldu l- vajrus PCV2 jekk huma jiġu esposti għalih wara li jitwieldu.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Circovac been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Circovac?
Circovac has been studied in several trials in pregnant pigs of various breeds.
Circovac ġie studjat f’ diversi provi fi ħnieżer tqal ta ’ diversi razez.
Both sows and gilts (and their piglets) were investigated in these studies, some of which were carried out under laboratory conditions and some on farms.
Kemm il- majjaliet kif ukoll il - ħnieżer nisa żgħar (u l- qżieqeż tagħhom) ġew mistħarrġa f’ dawn l- istudji, xi wħud saru taħt kondizzjonijiet tal- laboratorju u xi uħud fl- irziezet.
The effectiveness of the product was demonstrated by measuring the amount of antibodies to PCV2 in the blood of the vaccinated sows (or gilts) and also in the blood of their piglets (after they have had the colostrum).
L- effikaċja tal- prodott intweriet bit- tkejjil ta ’ l - ammont ta ’ antikorpi għal PCV2 fid- demm ta ’ ħnieżer nisa (jew ħnieżer nisa żgħar) imlaqqma kif ukoll fid- demm tal- qżieqeż tagħhom (wara li jkunu ħadu l- kolostrum).
The effectiveness of the product was further investigated in piglets which were directly exposed to the virus, by observing them for the development of circovirus-related symptoms.
L- effikaċja tal- prodott ġiet ukoll mistħarrġa fil- qżieqeż li kienu esposti direttament għall- vajrus, billi dawn ġew osservati għall - iżvilupp ta ’ xi sintomi relatati ma ’ circovirus.
Parameters such as body weight, and the amounts of PCV2 found in some specific lymph nodes and in their blood and faeces, were taken into account.
Parametri bħall- piż tal- ġisem, u l- ammonti ta ’ PCV2 li nstabu f’ xi glandoli limfatiċi speċifiċi u fid- demm u l- ippurgar tagħhom, tqiesu wkoll.
Additionally, the overall number of deaths occurring in field conditions amongst piglets born to vaccinated sows and gilts was investigated and compared to those born to unvaccinated mothers.
Barra minn hekk, in- numru totali ta ’ mwiet li seħħew f’ kondizzjoni normali fost qżieqeż li twieldu lil ħnieżer nisa (kemm majjaliet kif ukoll ħnieżer nisa żgħar) imlaqqma ġie mistħarreġ u mqabbel man- numru ta ’ mwiet li seħħew fost ommijiet mhux imlaqqma.
The length of time that Circovac is effective in the piglets has also been studied.
It- tul ta ’ żmien li matulu Circovac huwa effettiv fil- qżieqeż ġie studjat ukoll.
The main measure of the immune response was the level of antibodies against PCV2 in the piglets’ blood.
Il- miżura ewlenija tar - reazzjoni immunitarja kienet il- livell ta ’ antikorpi kontra PCV2 fid- demm tal- qżieqeż.
What benefit has Circovac shown during the studies?
X’ benefiċċju wera Circovac waqt l- istudji?
The trials showed that vaccination of the mothers with Circovac can reduce the incidence of lesions associated with circovirus infection in the lymphoid tissues of their piglets.
Il- provi wrew li t- tilqim ta ’ l- ommijet b’ Cirovac jista ’ jnaqqas l- inċidenza ta ’ leżjonijiet assoċjati ma ’ infezzjoni b’ circovirus fit- tessuti limfojde tal- qżieqeż tagħhom.
Although the outcome of some of the trials was partially compromised by the complex nature of PCV2 infections, the large number of pigs involved (from 63 farms) and the variety of experimental and clinical conditions did show a reduction in the overall death rates of piglets related to circovirus infections of between 3.6% and 10%.
Għalkemm ir- riżultat ta ’ xi wħud mill - provi kien parzjalment kompromess min- natura kumplessa ta ’ infezzjonijiet b’ PCV2, in- numru kbir ta ’ ħnieżer involuti (minn 63 razzett) u l- varjetà ta ’ kondizzjonijiet sperimentali u kliniċi wrew tnaqqis fir- rata totali ta ’ imwiet tal- qżieqeż relatati ma ’ infezzjonijiet b’ circovirus ta ’ madwar 3. 6% u 10%.
Immunity in piglets born from vaccinated gilts or sows was shown to last for up to five weeks after they drank the colostrum.
L- immunità fil- qżieqeż imwielda minn ħnieżer nisa (kemm majjaliet kif ukoll ħnieżer nisa żgħar) imlaqqma ġiet ippruvata li damet għal ta ’ l- anqas ħames ġimgħat wara li xorbu l- kolostrum.
What is the risk associated with Circovac?
X’ inhu r- riskju assoċjat ma ’ Circovac?
Circovac can cause a harmless temporary redness or swelling at or around the injection site, which can last for up to four days after the injection.
Sa jumejn wara l- injezzjoni, il- ħnieżer jista ’ jkollhom żieda ta ’ 1. 4°C fit- temperatura tal- ġisem, u f’ xi ħnieżer din tista ’ tkun ukoll ta ’ 2. 5°C.
Following injection, pigs may have an increased body temperature of 1.4°C for up to two days, and in some pigs of up to 2.5°C, but this should not last more than 24 hours after the injection.
Madanakollu din m’ għandhiex iddum aktar minn 24 siegħa wara l- injezzjoni.
Other rarer side effects in the injected pigs are reduced activity and food intake, but these are also temporary.
Effetti sekondarji oħra aktar rari fil- ħnieżer injettati huma t- tnaqqis ta ’ l- attività u fit- teħid ta ’ l- ikel, iżda dawn huma wkoll temporanji.
For a full list of all side effects reported with Circovac, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Cirovac, ara il- Fuljett ta ’ Tagħrif.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li għandha tieħu l- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal?
Circovac contains mineral oil.
Cirovac fih żejt minerali.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger, which can in rare cases lead to the loss of the finger.
Injezzjoni aċċidentali tista ’ tikkaġuna uġigħ u nefħa qawwija, partikolarment jekk injettata f’ ġog jew saba ’, li f’ każijiet rari tista ’ twassal għal telf tas- saba ’.
If someone is accidentally injected with even a very small amount of this product, they must seek medical advice immediately and the Package Leaflet should be shown to the doctor.
Jekk xi ħadd aċċidentalment jiġi injettat anke b’ ammont tassew żgħir ta ’ dan il- prodott, dan għandu jfittex parir mediku minnufih u għandu juri l- Fuljett ta ’ Tagħrif lit- tabib.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Jekk l- uġigħ jippersisti għal aktar minn 12- il siegħa wara l- eżami mediku, it- tabib għandu jerġa ’ jiġi kkuntattjat.
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
X’ inhu ż- żmien li jrid jitħalla qabel ma ’ l- annimal jinqatel u l- laħam jintuża għal konsum tal - bniedem (perijodu ta ’ irtirar)?
Zero days.
Xejn ġranet.
Why has Circovac been approved?
Għaliex ġie approvat Circovac?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Circovac outweigh its risks for the reduction of the lesions in lymphoid tissues which are associated with circovirus infection in piglets and also to help reduce deaths connected with this disease in piglets.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Cirovac jegħlbu r- riskji tiegħu għat- tnaqqis ta ’ leżjonijiet f’ tessuti limfojde li huma assoċjati ma ’ circovirus fil - qżieqeż u wkoll biex jitnaqqsu l- imwiet assoċjati ma ’ din il- marda fil- qżieqeż.
They recommended that Circovac should be given a marketing authorisation.
Huma rrakkomandaw li Cirovac jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ benefiċċju/ riskju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR.
Other information about Circovac:
Tagħrif ieħor dwar PRILACTONE:
The European Commission granted a marketing authorisation valid throughout the European Union for Circovac to Merial on 21 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l- Unjoni Ewropea kollha għal Circovac lil Merial fil- 21 ta ’ Ġunju 2007.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq il- pakkett ta ’ barra.
This summary was last updated in June 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Ġunju 2007
EMEA Number
Numru EMEA
Invented Strength Name
Isem Ivvintat
Target Species
Speċi li fuqhom se jintuża lprodott
Route of Administration
Mod ta ’ Amministrazzjoni
Package Size
Daqs tal - pakkett
Inactivated porcine circovirus type 2: at least 2.1 log 10 ELISA U per 2 ml dose
Circovirus tal - ħnieżer tat- tip 2 inattivat: għall - inqas 2. 1 log 10 ELISA U għal kull 2ml ta ’ doża
Emulsion and suspension for emulsion for injection
Emulsjoni u suspensjoni għal emulsjoni għall - injezzjoni
Pigs (gilts and sows)
Ħnieżer (ħnieżer nisa żgħar u ħnieżer nisa)
Suspension: vial (glass) Emulsion: vial (glass)
Għal użu għal ġol - muskoli
5 doses Emulsion:
Suspensjoni: kun Suspensjoni: kunjett 1 jett (tal- ħġieġ) 5 dożi + kunjett 1 Emulsjoni: kunje tt (tal- ħġieġ) Emulsjoni:
5 doses
5 dożi
Zero days
Xejn
Suspension:
Circovirus tal - ħnieżer tat- tip 2 inattivat: għall - inqas 2. 1 log 10 ELISA U għal kull 2ml ta ’ doża
5 doses Emulsion:
Għal użu għal ġol - muskoli
Inactivated porcine circovirus type 2: at least 2.1 log 10 ELISA U per 2 ml dose
Circovirus tal - Ħnieżer tip 2 inattivat: għall - inqas 2. 1 log 10 ELISA U għal kull 2ml ta ’ doża
25 doses 1
Suspensjoni: kun Suspensjoni: kunjett 1 jett (tal- ħġieġ) 25 doża + kunjett 1 Emulsjoni: kunje Emulsjoni: tt (tal- ħġieġ) 25 doża
25 doses
Circovirus tal - ħnieżer tat- tip 2 inattivat: għall - inqas 2. 1 log 10 ELISA U għal kull 2ml ta ’ doża
10 vials +
Emulsjoni u suspensjoni għal emulsjoni għall - injezzjoni
at least 2.1 log 10 ELISA U per 2 ml dose
Ħnieżer (ħnieżer nisa żgħar u ħnieżer nisa)
emulsion for injection
Għal użu għal ġol - muskoli
Emulsion: vial (glass)
Suspensjoni: kun Suspensjoni:
Emulsion:
Xejn
Circovac Emulsion and suspension for emulsion for injection for pigs
Circovac Emulsjoni u suspensjoni għal emulsjoni għall- injezzjoni għall- ħnieżer
One reconstituted 2 ml dose contains:
Doża waħda ta ’ 2 ml rikostitwita fiha:
Inactivated porcine circovirus type 2 (PCV2)................................................ ≥ 2.1 log10 ELISA. Units Excipient:
Ingredjenti oħra:
Thiomersal................................................................................................................................. ..0.20 mg Adjuvant:
Tiomersal...................................................................................................................................... 0. 20 mg Adjuvant:
494 to 501 mg
Żejt tal- paraffin ħafif...................................................................................................... 494 għal 501 mg
Emulsion and suspension for emulsion for injection.
Emulsjoni u suspensjoni għal emulsjoni għall- injezzjoni.
Pigs (gilts and sows).
Ħnieżer (ħnieżer nisa żgħar u majjaliet).
Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2- linked mortality.
Tilqim passiv tal- qżieqeż permezz tal- kolostrum, wara t- tilqim attiv tal- ħnieżer nisa żgħar u majjaliet, biex jonqsu l- feriti fit- tessuti tal- limf assoċjati ma ’ l- infezzjoni b’ PCV2 u bħala għajnuna biex jonqsu l- imwiet relatati mal- PCV2.
Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake.
Żmien ta ’ immunità: sa 5 ġimgħat wara t- trasferiment passiv ta ’ antikorpi permezz tat- teħid tal - kolostrum.
Vaccinate only healthy animals.
Laqqam biss annimali b’ saħħithom.
Apply usual procedures for the handling of animals.
Uża l- proċeduri tas- soltu meta tiġi biex tagħti t- trattament lill- annimali.
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
To the user:
Għal min se juża:
This product contains mineral oil.
Dan il- prodott fih żejt minerali.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa specjalment jekk tinjetta f' ġog jew subgħa u f' kazijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi injettat bi żball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna ġie injettat u ħu il- fuljetta ta 'informazzjoni li tinsab fil- pakkett miegħek.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ idum għal aktar minn tnax- il siegħa wara l- eżami mediku, erġa 'kellem lit- tabib.
To the physician:
Għat- Tabib:
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il - prodott tista 'tikkawża nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l- bżonn li jinqata 'xi subgħa.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata mal- ewwel u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata l- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il - laħam tas- subgħa u t- tendin tal- muskolu.
Slight and transient local reactions normally occur after the administration of one dose of vaccine, mainly swelling (up to 2 cm2 in average) and redness (up to 3 cm2 in average), and in some cases oedema (up to 17 cm2 in average).
Wara li tingħata doża waħda tat- tilqima, normalment ikun hemm reazzjoni lokali ħafifa jew momentarja, l- aktar nefħa (sa medja ta ’ 2 ċm2) u ħmura (sa medja ta ’ 3 ċm2), u f’ xi każijiet edema (sa medja ta ’ 17 ċm2).
These reactions resolve spontaneously in maximum 4 days in average without any consequence on the health and the zootechnical performances.
Dawn ir- reazzjonijiet jgħaddu waħedhom bejn wieħed u ieħor fi żmien erbat ’ ijiem mingħajr konsegwenzi fuq is- saħħa u l- imġieba żooteknika.
In clinical studies, the post-mortem examination of the injection sites performed at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals, as well as necrosis or fibrosis in approximately half of the animals.
Fi studji kliniċi, l- investigazzjoni li saret fuq il- postijiet fejn ingħatat l- injezzjoni sa mhux aktar minn 50 ġurnata wara li ngħatat it- tilqima, urew feriti limitati fosthom telf fil- kulur u granuloma fil- biċċa l - kbira ta ’ l- annimali, kif ukoll nekrożi jew fibrożi f’ madwar nofs l- annimali.
Within the 2 days following the injection, an average increase in rectal temperature of up to 1.4°C can occur.
Sa jumejn wara l- injezzjoni, jista ’ jkun hemm żjieda medja fit- temperatura tal- warrani ta ’ mhux aktar minn 1. 4°C.
Rarely, an increase in rectal temperature of higher than 2.5°C, lasting less than 24 hours, may occur.
F’ każijiet rari, jista ’ jkun hemm żjieda fit- temperatura tal- warrani ta ’ aktar minn 2. 5°C u din iddum inqas minn 24 siegħa.
In rare cases, slight apathy or reduction in appetite may be observed, which should resolve spontaneously.
Dawn għandhom jgħaddu waħedhom.
Vaccination may exceptionally cause hypersensitivity reactions.
F’ każijiet eċċezzjonali, it- tilqim jista ’ jikkawża reazzjonijiet ta ’ sensittività eċċessiva.
In such cases, an appropriate symptomatic treatment should be provided.
F’ każijiet bħal dawn, għandu jiġi pprovdut trattament addattat għas- sintomi.
Exceptionally abortion may occur after vaccination.
F’ każijiet eċċezzjonali jista ’ jkun hemm abort wara t- tilqim.
Can be used during pregnancy.
Jista 'jintuża waqt it- tqala.
Use during lactation – not applicable.
Użu fi żmien il- ħalib - Mhux applikabbli.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma ’ kwalunkwe prodott ieħor.
It is therefore recommended that no other vaccines should be administered concurrently within 14 days before or after vaccination with the product.
Għaldaqstant huwa rakkomandat li ma tintuża l- ebda tilqima oħra fi żmien 14- il jum qabel jew wara li tlaqqam b' dan il- prodott.
4.9 Amounts to be administered and administration route
3 4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Reconstitute immediately after removal from the refrigerator (or other cold storage).
Irrikostitwixxi minnufih wara li tneħħi l- prodott mill- friġġ (jew minn post ieħor li jkessaħ).
3 To use the vaccine, shake vigorously the vial of antigen suspension and inject its content into the vial of emulsion containing adjuvant.
Biex tuża t- tilqima, ħawwad sew il- flixkun bis- suspensjoni ta ’ l- antiġen u injetta l- kontenut tiegħu fil - flixkun ta ’ l- emulsjoni li fiha l- adjuvant.
Gently mix before use.
Ħawwad bil- mod qabel ma tuża.
The reconstituted vaccine is a homogeneous white emulsion.
It- tilqima rikostitwita hi emulsjoni bajda omoġenja.
Administer one 2 ml dose by deep intramuscular injection in accordance with the following vaccination scheme:
Agħti doża waħda ta ’ 2 ml permezz ta ’ injezzjoni fil- fond ġol- muskolu skond l- iskema li ġejja għat - tilqim:
Basic vaccination: • Gilts:
Tilqim bażiku: • Ħnieżer nisa żgħar:
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before mating.
Injezzjoni waħda, bit- tieni injezzjoni bejn 3 u 4 ġimgħat wara, mill- inqas ġimagħtejn qabel it- tgħammir.
One further injection must be given, at least 2 weeks before farrowing. • Sows:
Għandha tingħata injezzjoni oħra, sa mill- inqas ġimagħtejn qabel ma l- ħanżira tferragħ. • Majjaliet:
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before farrowing.
Injezzjoni waħda, bit- tieni injezzjoni bejn 3 u 4 ġimgħat wara, u sa mill- inqas ġimagħtejn qabel mal- ħanżira tferragħ.
Revaccination: • One injection at each gestation, at least 2 to 4 weeks before farrowing.
Tilqim mill- ġdid: • Injezzjoni waħda f’ kull tqala, għallinqas bejn ġimagħtejn u 4 ġimgħat qabel ma l- ħanżira tferragħ.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
L- ebda reazzjoni avversa, ħlief dawk imsemmiija fis- sezzjoni 4. 6, ma ntweriet wara li ngħatat doża doppja tat- tilqima.
Swine inactivated viral vaccine ATC vet code:
Tilqima virali inattiva għall- ħnieżer Kodici ATĊ veterinarja:
The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/ w).
It- tilqima rrikonstitwita fiha Ċirkovirus tal- ħnieżer tat- tip 2 inattivat (PCV2) f’ adjuvant żejtni (o/ w).
It is intended to stimulate active immunity in gilts and sows to provide passive immunity in piglets, through colostrum intake.
Għandha l- għan li tqanqal l- immunità attiva fil- ħnieżer nisa żgħar u fil- majjaliet biex tipprovdi immunità passiva fil- qżieqeż, permezz tat- teħid tal- kolostrum.
Light paraffin oil (Emulsion) Thiomersal (Suspension and Emulsion) Sorbitan oleate (Emulsion) Polysorbate 80 (Emulsion) Polysorbate 85 (Emulsion) Sodium chloride/ potassium dihydrogen phosphate/ disodium phosphate dihydrate (Suspension and Emulsion) Water for injections
6. 1 Lista ta ’ ingredjenti Żejt tal- paraffin ħafif (Emulsjoni) Thiomersal (Suspensjoni u Emulsjoni) Sorbitan oleate (Emulsjoni) Polysorbate 80 (Emulsjoni) Polysorbate 85 (Emulsjoni) Sodium chloride/ potassium dihydrogen phosphate/ disodium phosphate dihydrate (Suspensjoni u Emulsjoni) Ilma għall- injezzjoni
Do not mix with any other medicinal product.
Tħallatx ma ’ prodotti mediċinali oħrajn.
4 6.3 Shelf life
6. 4 Tagħrif speċjali dwar kif għandu jinħażen
Store and transport refrigerated (2 °C – 8 °C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex ikun protett mid- dawl.
- 5 doses:
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size).
- 5 dożi: kunjett wieħed bis- suspensjoni (daqs 5 dożi) + kunjett wieħed bl- emulsjoni (daqs 5 dożi).
- 10 x 5 doses:
- 10 x 5 dożi:
10 vials of suspension (5 dose size) + 10 vials of emulsion (5 dose size).
10 kunjetti bis- suspensjoni (daqs 5 dożi) + 10 kunjetti bl- emulsjoni (daqs 5 dożi).
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size).
- 25 doża: kunjett wieħed bis- suspensjoni (daqs 25 doża) + kunjett wieħed bl- emulsjoni (daqs 25
- 10 x 25 doses:
- 10 x 25 doża:
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size).
10 kunjetti bis- suspensjoni (daqs 25 doża) + 10 kunjetti bl- emulsjoni (daqs 25 doża).
MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE
MERIAL 29 avenue Tony Garnier 69007 LYON FRANZA
Any person intending to import, sell, supply and/ or use Circovac must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use
5 L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'Circovac huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa ta ’ l- annimali.
5 Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Kull persuna li turi l- intenzjoni li timporta, tbigħ, tipprovdi u/ jew tuża Circovac għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbigħ, tipprovdi u/ jew tuża Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVVISTA JEW L- UŻU
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substance:
Isem u indirizz tal- manufattur tas- sustanza bioloġika attiva:
Mérial, Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon France
Mérial, Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon Franza
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott:
Mérial, Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Mérial, Laboratoire Porte des Alpes Rue de l' Aviation 69800 Saint Priest Franza
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVVISTA JEW L- UŻU
Veterinary medicinal product subject to medical prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jinforma lill- Kummissjoni Ewropea bil- pjanijiet biex jikkumerċjalizza l- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- djanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f ’ annimali ħajjin jew fl- ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
Not applicable.
Mhux appklikabbli.
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
Is- sustanzi li ġejjin misjuba fil- prodott finali huma inklużi fl- Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
MRL status Included in Annex II for all food producing species
Inkluż f’ Anness II għall - ispeċi kollha li jipproduċu l- ikel