qanastek/EMEA-V3 huggingface dataset:
Tear off a section from the blister at the perforation.
Aqta ’ biċċa mill- folja fil- perforazzjoni.
Peel the foil off at the unsealed area.
Qaxxar il- fojl fiż- żona li mhix issiġillata.
Push the tablet for release from the blister.
Imbotta l- pillola biex toħroġha minn ġol- folja.
Keep tightly closed.
Żomm magħluq tajjeb.
Return half tablets to the container.
Poġġi lura n- nofs pilloli fil- kontenitur.
Do not use after the expiry date (EXP) stated on the label.
Tużax wara d- data ta ’ skadenza (EXP) li tidher fuq it- tikketta.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l- karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
Metacam 1 mg chewable tablets for dogs Bottle:
Metacam 1 mg pilloli li tomgħodhom għall- klieb
100 tablets Blisters:
100 pillola Folji:
10, 20, 100 or 500 tablets
10, 20, 100 jew 500 pillola
Metacam 2.5 mg chewable tablets for dogs Bottle:
Flixkun:
121/ 125 PACKAGE LEAFLET FOR:
121/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Meloxicam 0.5 mg/ ml (equivalent to 0.017 mg per drop)
Meloxicam 0. 5 mg/ ml (ekwivalenti għal 0. 017 mg kull qatra)
Alleviation of inflammation and pain in chronic musculo-skeletal disorders.
Għal serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku kroniku.
Initial treatment is a single oral dose of 0.1 mg meloxicam/ kg body weight on the first day.
It- trattament tal- bidu tikkonsisti minn doża waħda orali ta ’ 0. 1 mg ta ’ meloxicam għal kull kg ta ’ piż tal- ġisem fl- ewwel jum.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/ kg body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) tad- doża tal- manteniment ta ’ 0. 05 mg meloxicam kull kg ta ’ piż tal- ġisem.
Route (s) and method of administration Shake well before use.
Mod ta ’ kif u mnejn jingħata Ħawwad tajjeb qabel l- użu.
Alternatively and for cats with a body weight of at least 2 kg, the Metacam measuring syringe (provided in the package) can be used.
Alternattivament, u għal qtates b’ piż tal- ġisem ta ’ mill- inqas 2 kg, tista ’ tintuża s- siringa tal- kejl ta ’ Metacam (ipprovduta fil- pakkett).
6 drops / kg body weight Maintenance dose:
6 qatriet / kg ta ’ piż tal- ġisem Doża ta ’ manteniment:
3 drops / kg body weight
3 qatriet / kg ta ’ piż tal- ġisem
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Is- siringa teħel mal- qattara tal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi mad- doża ta ’ manuteniment.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Għalhekk, fl- ewwel jum tat- terapija, ser ikun meħtieġ id- doppju tal - volum tal- manteniment.
Push down and unscrew bottle top.
Agħfas ’ l isfel u ħoll it- tapp tal- flixkun.
Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.
Waħħal is- siringa tad- dożaġġ mal- qattara tal - flixkun billi timbotta bil- mod.
Turn the bottle/ syringe upside down.
Aqleb il- flixkun/ is- siringa ta ’ taħt fuq.
Pull the plunger out until the black line on the plunger corresponds to your cat ´ s bodyw eight in kilogram s.
Iġbed il- planġer ’ il barra sakemm is- sinjal iswed fuq il- planġer ikun jikkorrispondi mal- piż tal - ġisem tal- qattus tiegħek f’ kilogrammi.
Turn the bottle right way up and w ith a tw isting m ovem ent separate the dosing syringe from the bottle.
Dawwar il- flixkun lura kif suppost u permezz ta ’ moviment li jilwi, issepara s - siringa tad- dożaġġ minn mal - flixkun.
B y pushing the plunger in em pty the contents of the syringe onto the food or directly into the m outh.
Imbotta l- planġer ’ l isfel u battal il- kontenut tas- siringa fuq l- ikel jew direttament ġol - ħalq.
A clinical response is normally seen within 7 days.
Rispons kliniku ġeneralment ikun osservat wara 7 ijiem.
Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 14- il jum, l- ebda titjib kliniku ma jkun evidenti.
Please carefully follow the instructions of the veterinarian.
Jekk jogħġbok segwi bl- attenzjoni l- istruzzjonijiet tal- veterinarju.
Metacam 0.5 mg/ ml oral suspension for cats should not be used following parenteral injection of meloxicam or any other NSAID as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Metacam 0. 5 mg/ ml suspensjoni orali għal qtates m’ għandhiex tintuża wara injezzjoni parenterali ta ’ meloxicam jew kwalunkwe korsijiet adattati oħrajn ta ’ dożaġġ ta ’ NSAIDs, għax kuri follow- up bħal dawn ma kienux stabbiliti fil- qtates.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Fil- perjodu mingħajr trattament, madankollu, għandu jkun ikkunsidrat il - karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
Overdose Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Doża eċċessiva Meloxicam għandu marġni ta ’ sigurtà terapewtika żgħira fil- qtates, u sinjali kliniċi ta ’ doża eċċessiva jistgħu jkunu osservati f’ livelli ta ’ doża eċċessiva relattivament żgħar.
In case of overdose, adverse reactions, as listed in Section "Adverse reactions", are expected to be more severe and more frequent.
F’ każ ta ’ doża eċċessiva, reazzjonijiet avversi, kif elenkati f’ Sezzjoni `Effetti mhux mixtieqa´ huma mistennija li jkunu iktar severi u iktar frekwenti.
13.
124/ 125 13.
15 OTHER INFORMATION
TAGĦRIF IEĦOR
15 ml bottle.
Flixkun ta ’ 15 ml.
EU Number
Numru ta ’
Tradename
Isem tal -
Pharmaceutical form
Daqs tal -
Target species
l’ Unjoni Ewropea
Route of administration
prodott fil - kummerċ
Withdrawal period
ta ’ tiżmim
adhesins F4 (F4ab, F4ac, F4ad), at least 2.1 SA. U* adhesin F5, at least 1.7 SA. U* adhesin F6, at least 1.4 SA. U* adhesin F41, at least 1.7 SA. U*
adhesins F4 (F4ab, F4ac,
Suspension for injection
F4ad), mill- inqas 2. 1 SA. U *
Pigs (sows and gilts)
(majjaliet u
Intramuscular injection
Injezzjoni fil -
Glass type I vial with butyl rubber stopper
ħġieġ tat- Tip I bit- tapp tal - gomma
Box of 5-dose 10 ml vial
kunjett ta’ 10 ml
10 ml vial
ta ’ 10 ml
Suspension for injection
Kunjett tal -
Pigs (sows and gilts)
qażqużiet).
Intramuscular injection
Injezzjoni fil - muskolu
Box of 10-dose 20 ml vial
10 - doża kunjett ta ’ 20 ml
20 ml vial
ta ’ 20 ml
Box of 25-dose 50 ml vial
25 - doża kunjett ta ’ 50 ml
50 ml vial
ta ’ 50 ml
Box of 50-dose 100 ml vial
50 - doża kunjett ta’ 100 ml
100 ml vial
ta ’ 100 ml
NEOCOLIPOR EPAR summary for the public
NEOCOLIPOR Sommarju tal- EPAR għall- pubbliku
What is Neocolipor?
X' inhu Neocolipor?
Neocolipor is an inactivated vaccine intended to be used to reduce neonatal enterotoxicosis (a bacterial infection caused by strains of E. coli) in very young piglets.
Neocolipor huwa vaċċin inattivat biex jintuża għat- tnaqqis tal- enterotossikożi neonatali (infezzjoni batterika kkawżata minn strains ta 'E. coli) fi driefeġ ta' età ċkejkna.
What is Neocolipor used for?
Għal xiex jintuża Neocolipor?
Neocolipor is administered to female pigs – both sows and gilts - in order to immunise their offspring against neonatal enterotoxicosis.
Neocolipor jingħata lill- ħnieżer nisa anki jekk għadhom ta 'età żgħira (gilts) għall- immunizzazzjoni tal- għalla tagħhom kontra l- enterotossikożi neonatali.
Gilts are animals which have produced fewer than two litters.
Il- ħnieżer nisa ta 'età żgħira (gilts) huma dawk il- ħnieżer li wildu inqas minn żewġ għalliet driefeġ.
The vaccine is given by intramuscular injection.
Il- vaċċin jingħata b' injezzjoni intramuskolari.
How does Neocolipor work?
Kif jaħdem Neocolipor?
Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (_BAR_K88 ad) F5 (K99) F6 (987P) and F41.
Neocolipor fih strains inattivati ta 'E. coli li jesprimu l- adeżini (adhesins) F4ab (K88ab), F4ac (K88ac), F4ad (_BAR_K88 ad) F5 (K99) F6 (987P) u F41.
Vaccination of the mother animal (sows and gilts) enables the offspring to receive a passive immunity during their first days of life against neonatal enterotoxicosis caused by E. coli strains carrying the adhesins F4, F5, F6 and F41.
Il- vaċċinazzjoni tal- omm (ħanżira jew ħanżira ta 'età żgħira) tittrasmetti lid- driefeġ immunizzazzjoni passiva matul l- ewwel jiem ta' ħajja kontra l- enterotossikożi neonatali kkawżata minn E. coli li ġġorr l- adeżini F4, F5, F6 u F41.
The vaccine is intended for use 5-7 weeks before the birth of the litter (farrowing) with a second vaccination at 2 weeks prior to farrowing.
Il- vaċċin għandu jintuża bejn 5 u 7 ġimgħat qabel ma titwieled l- għalla u t- tieni vaċċinazzjoni ġimagħtejn qabel ma titwieled l- għalla.
A booster vaccination is given 2 weeks prior to each subsequent farrowing.
Sussegwentement, tingħata vaċċinazzjoni booster ġimagħtejn qabel kull darba li l- ħanżira tiled għalla driefeġ.
How has Neocolipor been studied?
Kif ġie studjat Neocolipor?
A number of trials were carried out in both the laboratory and in the field in order to assess the efficacy of the product.
Twettqu għadd ta 'provi kemm f' laboratorju kif ukoll fuq il- post sabiex tiġi vvalutata l- effikaċja tal - prodott.
Safety data were also presented for the recommended use of the product both under laboratory conditions and in the field.
Ġiet ukoll ippreżentata dejta dwar is- sigurtà għall- użu rakkomandat tal- prodott f' kundizzjonijiet kemm ta 'laboratorju kif ukoll ta' fuq il- post.
Safety of the product was satisfactorily demonstrated.
Is- sigurtà tal- prodott intweriet b' mod sodisfaċenti.
What benefit has Neocolipor shown during the studies?
Liema benefiċċju wera Neocolipor waqt l- istudji mwettqa?
The results presented showed statistical significance between vaccinates and non-vaccinates and thus demonstrated the efficacy of the vaccine.
Ir- riżultati ppreżentati wrew differenza statistikament sinifikanti bejn l- annimali vaċċinati u dawk mhux vaċċinati, b' hekk intweriet l- effikaċja tal- vaċċin.
Re-vaccination was shown to be effective at the intervals recommended.
Il- vaċċinazzjoni mill- ġdid irriżultat effikaċi fl - intervalli rakkomandati.
What are the side-effects of Neocolipor?
X' inhuma l- effetti sekondarji ta 'Neocolipor?
Vaccination may cause a slight rise in the animal’ s body temperature (less than 1.5°C during a maximum period of 24 hours).
Il- vaċċinazzjoni tista 'tikkawża żieda ċkejkna fit- temperatura tal- ġisem tal- annimal (inqas minn 1. 5°C matul perjodu massimu ta' 24 siegħa).
In the case of accidental self injection, seek medical advice immediately and show the package insert or label to a physician.
Fil- każ ta 'awtoinjezzjoni aċċidentali, itlob parir mediku minnufih u uri l- fuljett ta' tagħrif jew it - tikketta lit- tabib.
Zero days (the vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated animals at the recommended dose).
Ebda ġurnata (il- vaċċin ma fihx ingredjenti li jistgħu jirrappreżentaw riskju għall- konsumaturi ta 'annimali vaċċinati bid- doża rakkomandata).
Why has Neocolipor been approved?
Għaliex ġie approvat Neocolipor?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Neocolipor had been shown to be effective in the reduction of neonatal enterotoxicosis in piglets.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkunsidra li, skont ir- rekwiżiti tal- Unjoni Ewropea, Neocolipor wera ruħu effikaċi fit- tnaqqis tal- enterotossikożi neonatali tad- driefeġ.
Other information about Neocolipor:
Aktar tagħrif dwar Neocolipor:
The European Commission granted a marketing authorisation, valid throughout the European Union, for Neocolipor to Mérial on 9 August 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Neocolipor lil Mérial fid- 9 ta 'Awwissu 2002.
The Marketing Authorisation was subsequently renewed.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet sussegwentement imġedda.
This summary was last updated in August 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Neocolipor suspension for injection
Neocolipor suspensjoni għal injezzjoni
Active substances: per dose of 2 ml:
Sustanzi attivi: għal kull doża ta ’ 2 ml.
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least … .2.1 SA. U* E. coli adhesin F5, at least……………………… 1.7 SA. U* E. coli adhesin F6, at least ……………………… 1.4 SA. U* E. coli adhesin F41, at least…………………… .1.7 SA. U*
2. 1 SA. U * E. coli adhesin F5, mill- inqas....................................................................................................
*:
1. 7 SA. U * *:
1 SA. U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
1 SA. U: kwantita ’ suffiċjenti biex ikollok titolu ta ’ agglutinating antibody ta ’ 1 log 10 fil- fenek ta ’ l- Indi.
Aluminium (as hydroxide)
Aluminju (bħala hydroxide)..........................................................................................................
Pigs (sows and gilts).
Majjal (majjaliet u qażqużiet).
Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Tnaqqis ta ’ enterotoxicosi fid- drafeġ tat- twelid, ikkaġunat mil- istrains tal- E. coli li jesprimu l- adhesins F4ab, F4ac, F4ad, F5, F6 u F41, fl- ewwel ftit jiem tal- ħajja.
- Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a
- Billi d- drafeġ huma protetti meta jieħdu il- colostrum, kull darfuġ għandu jieħu kwantita ’ biżżejjed ta ’
sufficient quantity of colostrum within 6 hours of birth.
colostrum fl- ewwel 6 sigħat wara t- twelid.
- Vaccinate only healthy animals.
- Laqqam biss annimali f’ saħħithom.
- Do not administer in conjunction with other medicinal products.
- Tamministrax ma prodotti oħra mediċinali.
2/ 18 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 20 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In the case of accidental self injection, seek medical advice immediately and show the package insert or label to a physician.
F' każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
Wash and disinfect hands after use.
Aħsel u ddiżinfetta idejk wara l- użu.
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Il- vaċċin jista jikkaġuna hyperthermia ħafifa (inqas minn 1. 5 ċentigradi waqt perjodu massimu ta ’ 24 siegħa).
No special precautions.
L- ebda prekawzjoni speċjali
No information is available on the compatibility of this vaccine with any other.
M’ hemm l- ebda informazzjoni dwar il- kompatibilità ta ’ dan il- vaċċin ma xi ieħor.
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated
Għaldaqstant is- sigurtà u l- effiċjenza ta ’ dan il- prodott meta jiġi użat mi xi ieħor (jew meta jiġi użat fl- istess ġurnata jew f’ okkażjonijiet differenti) ma ġewx dimostrati.
Shake the vial vigorously before use.
Ħawwad il- kunjett sew qabel tużah.
Use sterile syringe and needles.
Uża siringi u labar sterilizzati.
Administer using aseptic procedures.
Amministra l- prodott bi proċeduri asettiċi.
One 2 ml dose intramuscularly in the neck in the area behind the ear, according to the following schedule:
Doża waħda ta ’ 2 ml fil- muskolu ta’ l- għonq, fil- parti wara l- widna, skond il- programm li ġej:
Primary vaccination:
L- ewwel programm ta ’ tilqim:
First injection:
L- ewwel titqiba:
Second injection:
It- tieni titqiba:
5 to 7 weeks before farrowing 2 weeks before farrowing.
5 sa 7 ġimgħat qabel it- twelid ġimgħatejn qabel it- twelid
Revaccination:
Kumplament ta ’ tilqim
1 injection 2 weeks before each subsequent farrowing.
Injezzjoni waħda ġimgħatejn qabel kull twelid sussegwenti
No undesirable effects have been observed after the administration of twice the recommended dosage.
L- ebda effett mhux mixtieq ma ġie osservat wara li ġie mogħti id- doppju tad- doża irrikkmandata.
ATC vet code:
ATĊ kodiċi veterinarju:
The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant.
Il- vaċċin fih l- istrains inattivati tal- E. coli li jesprimu l- adhesins F4ab, F4ac, F4ad, F5, F6 u F41, li jikkaġunaw enterotoxicosis fid- drafeġ tat- twelid, fl- adjuvant ta ’ l- aluminju hydroxide.
In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Fil- majjaliet u fil- qażqużiet, il- vaċċin jinduċi seroconversion speċifiku tal- annimali imlaqqma; id- drafeġ huma immunizzati passivament billi jieħdu il- colostrum u l- ħalib li fih adhesin- specific antibodies.
Do not mix with any other vaccine.
Tħallatx ma tilqim ieħor.
18 months at 2 - 8 °C.
18 il- xahar f’ temperatura ta ’ 2˚ sa 8˚C.
Broached vial:
Kunjett miftuħ:
3 hours.
3 sigħat.
Store and transport at 2°C - 8°C, protected from light.
Aħżen u ttrasporta f’ temperatura ta ’ 2°C - 8°C, protett mid- dawl.
Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper).
Kaxxa ta ’ 5 dożi, kunjett ta ’ 10 ml (kunjett tal- ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 10 dożi, kunjett ta ’ 20 ml (kunjett tal- ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 25 doża, kunjett ta ’ 50 ml (kunjett tal- ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 50 doża, kunjett ta ’ 100 ml (kunjett tal- ħġieġ bit- tapp tal- lasktu)
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE OF FIRST RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
4/ 18 10 DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // emea. europa. eu
5/ 18 ANNEX II
5/ 20 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) 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(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MERIAL Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCE
MERIAL Laboratoire de Toulouse 4 Chemin du Calquet 31000 TOULOUSE FRANCE
Manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott.
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F-69800 SAINT PRIEST
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 SAINT PRIEST FRANCE
Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l’ Agriculture et de la Forêt on 31 March 1992.
L- awtorizzazzjoni tal- manifattura ġiet maħruġa mill- Ministère des Affaires Sociales, Ministère délégué à la Santé, u l- Ministère de l’ Agriculture et de la Forêt franċiżi fil 31 ta ’ marzu 1992.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju mogħti biss bi preskrizzjoni.
STATEMENT OF THE MRLs WHICH ARE ACCEPTED IN ACCORDANCE WITH COUNCIL REGULATION (EEC) No 2377/ 90
DIKJARAZZJONI TA ’ L- MRLs
Annex II of Council Regulation (EEC) No 2377/ 90
Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90
Pharmacologically substance(s)
Sustanza( i)
active
Speċje ta ’
Animal species
Dispożizzjonijiet oħrajn
Other provisions
l- annimal
Aluminium hydroxide1
Aluminium hydroxide1
All food producing species
L- ispeċi kollha ta ’ l- ikel
All food producing species
L - ispeċi kollha ta ’ l- ikel
For use only as a preservative in multidose vaccines at concentration not exceeding 0.02%
Biex jintuża biss bħala preservattiv fil- vaċċini multidoża b’ konċentrat ta ’ mhux iżjed minn 0. 02%.
Sodium hydroxide3 Sodium chloride4
Sodium hydroxide3 Sodium chloride4
All food producing species All food producing species
L - ispeċi kollha ta ’ l- ikel L - ispeċi kollha ta ’ l- ikel
Hydrochloric acid5
Hydrochloric acid5
For use as excipient
Biex jintuża bħala ingredjent mhux attiv
1 OJ No L 290 of 05.12.95 2 OJ No L 110 of 26.04.97 3 OJ No L 272 of 25.10.96 4 OJ No L 290 of 05.12.95 5 OJ No L 143 of 27.06.95
1 OJ Numru L 290 tal- 5. 12. 95 2 OJ Numru L 110 tas- 26. 04. 97 3 OJ Numru L 272 tal- 25. 10. 96 4 OJ Numru L 290 tal- 5. 12. 95 5 OJ Numru L 143 tas- 27. 06. 95
7/ 18 ANNEX III
8/ 20 ANNESS III
9/ 18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
per dose of 2 ml:
għal kull doża ta ’ 2 ml.
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least … .2.1 SA. U* E. coli adhesin F5, at least……………………… 1.7 SA. U* E. coli adhesin F6, at least ……………………… 1.4 SA. U* E. coli adhesin F41, at least…………………… .1.7 SA. U* … *:
E. coli adhesin F4 (F4ab, F4ac, F4ad), mill- inqas...................................................................... 2. 1 SA. U * E. coli adhesin F5, mill- inqas....................................................................................................... 1. 7 SA. U * E. coli adhesin F6, mill- inqas....................................................................................................... 1. 4 SA. U * E. coli adhesin F41, mill- inqas.................................................................................................... 1. 7 SA. U * *:
Aluminium (as hydroxide).............................................................................................................
Aluminju (bħala hydroxide).............................................................................................................
50 doses =100 ml vial.
5 dożi = kunjett ta ’ 10 ml 10 dożi = kunjett ta ’ 20 ml 25 doża = kunjett ta ’ 50 ml 50 doża = kunjett ta ’ 100 ml
Pigs (sows and gilts)
Majjali (majjaliet u qażqużiet)
Intramuscular injection
Injezzjoni fil- muskolu.
Zero days.
Żmien ta 'Tiżmim: xejn.
Shake the vial vigorously prior to use.
Ħawwad sew il- kunjett qabel tużah
Store and transport between 2ºC and 8ºC, protected from light.
Aħżen u ttrasporta f’ temperatura ta ’ bejn 2 °C u 8°C protett mid- dawl.
Shelf-life of broached vial:
Żmien li l- kunjett miftuħ jista ’ jinżamm fuq l- ixkaffa:
3 hours.
3 sigħat
For animal treatment only - to be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni medika.
100 ml vial.
kunjett ta ’ 10 ml kunjett ta ’ 20 ml kunjett ta ’ 50 ml kunjett ta ’ 100 ml
11/ 18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13/ 20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
{NATURE/ TYPE}
{GĦAMLA/ TIP}
Neocolipor Suspension for injection Pigs (sows and gilts)
Neocolipor Suspensjoni għall- injezzjoni.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Majjali (majjaliet u qażqużiet)
F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
2 ml = 1 dose 5d 2 ml = 1 dose 10 d 2 ml = 1 dose 25 d
2 ml = doża 5d 2ml = doża 10d 2 ml = doża 25d
10 ml vial 20 ml vial 50 ml vial
kunjett ta ’ 10 ml kunjett ta ’ 20 ml kunjett ta ’ 50 ml
EXP {month/ year} >
EXP {xahar/ sena}
12/ 18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14/ 20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Neocolipor Suspension for injection Pigs (sows and gilts)
Majjali (majjaliet u qażqużiet)
2.1 SA. U * F5, at least...................................................................................................................................
għal kull doża ta ’ 2 ml. adhesions:
1.4 SA. U * F41, at least.................................................................................................................................
F4 (F4ab, F4ac, F4ad), mill- inqas............................................................................................. 2. 1 SA. U * F5, mill- inqas.............................................................................................................................. 1. 7 SA. U * F6, mill- inqas.............................................................................................................................. 1. 4 SA. U * F41, mill- inqas............................................................................................................................ 1. 7 SA. U * *:
Aluminium (as hydroxide)................................................................................................................
Aluminju (bħala hydroxide).............................................................................................................
50 dose
50 doża
100 ml vial
kunjett ta ’ 100 ml
Shake vigorously prior to use Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
15/ 18 PACKAGE LEAFLET Neocolipor
17/ 20 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Neocolipor
MARKETING AUTHORISATION HOLDER MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE
SID L- AWTORIZZAZZJONI TAL- KUMMERĊ MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE
MANUFACTURER FOR THE BATCH RELEASE MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F-69800 SAINT PRIEST FRANCE
MANIFATTUR LI JĦALLI L- KONSENJA TMUR FIS- SUQ MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 SAINT PRIEST FRANCE
per dose of 2 ml:
għal kull doza ta ’ 2 ml.
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least … .2.1 SA. U* E. coli adhesin F5, at least……………………… 1.7 SA. U* E. coli adhesin F6, at least ……………………… 1.4 SA. U* E. coli adhesin F41, at least…………………… .1.7 SA. U* *:
E. coli adhesin F4 (F4ab, F4ac, F4ad), mill- inqas....................................................................... 2. 1 SA. U * E. coli adhesin F5, mill- inqas....................................................................................................... 1. 7 SA. U * E. coli adhesin F6, mill- inqas....................................................................................................... 1. 4 SA. U * E. coli adhesin F41, mill- inqas................................................................................................... 1. 7 SA. U * *:
Aluminium (as hydroxide).............................................................................................................
Aluminju (bhala hydroxide).............................................................................................................
Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
Vaċċin inattivat bl- adjuvant għat- tnaqqis ta ’ enterotoxicosi fid- drafeġ tat- twelid, ikkaġunat mil - istrains tal- E. coli li jesprimu l- adhesins F4ab, F4ac, F4ad, F5, F6 u F41.
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Il- vaċċin jista jikkaġuna hyperthermia ħafifa (inqas minn 1. 5 ċentigradi waqt perijodu massimu ta ’ 24 siegħa).
16/ 18 7.
18/ 20 7.
One 2 ml dose according to the following schedule:
Doża waħda ta ’ 2 ml skond il- programm li ġej:
1 injection 2 weeks before each subsequent farrowing.
qabel kull twelid sussegwenti
Intramuscular injection in the neck in the area behind the ear.
Injezzjoni fil- muskolu fl- għonq fil- parti wara l- widna.
Administer using aseptic procedures.
Amministra l- prodott bi proċeduri asettiċi
Store and transport at 2°C - 8°C, protected from light.
Aħżen u ttrasporta f’ temperatura ta ’ 2 – 8 gradi ċentigradi.
3 hours.
Il- kunjett miftuh jibqa tajjeb għal tliet sigħat.
- Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a
- Billi d- drafeġ huma protetti meta jieħdu il- colostrum, kull darfuġ għandu jieħu kwantita ’
sufficient quantity of colostrum within 6 hours of birth.
biżżejjed ta ’ colostrum fl- ewwel 6 sigħat wara t- twelid.
- Do not administer in conjunction with other medicinal products.
- Tamministrax ma prodotti oħra mediċinali
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated
Għaldaqstant is - sigurtà u l- effiċjenza ta ’ dan il- prodott meta jiġi użat mi xi ieħor (jew meta jiġi użat fl- istess ġurnata jew f’ okkażjonijiet differenti) ma ġewx dimostrati
In the case of accidental self injection, seek medical advice immediately and show the package insert or label to a physician.
F’ każ li tinjetta lilek innifsek, fittex tabib mill- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
Wash and disinfect hands after use.
Aħsel u ddiżinfetta idejk wara li tuża dan il- prodott.
17/ 18 13.
19/ 20 Tħallatx ma xi vaċċin ieħor
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // emea. europa. eu
Not all pack sizes may be marketed.
Kaxxa ta ’ 5 dożi, kunjett ta ’ 10 ml (kunjett tal- ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 10 dożi, kunjett ta ’ 20 ml (kunjett tal - ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 25 doża, kunjett ta ’ 50 ml (kunjett tal - ħġieġ bit- tapp tal- lasktu) Kaxxa ta ’ 50 doża, kunjett ta ’ 100 ml (kunjett tal - ħġieġ bit- tapp tal- lasktu) Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq.
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju li jingħata bil- preskrizzjoni.
EPAR summary for the public
NETVAX Sommarju tal- EPAR għall- pubbliku
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport Pubblika Ewropew ta ’ Valutazzjoni (EPAR).
What is Netvax?
X’ inhu Netvax?
Netvax is a vaccine that contains a toxoid (a weakened toxin) from the bacterium Clostridium perfringens (C. perfringens) type A.
Netvax huwa vaċċin li fih tossojde (tossina mdgħajfa) mill- batterju Clostridium perfringens (C. perfringens) tat- tip A.
The vaccine is an emulsion (a mixture of oil- and water-based liquids) for injection.
Il- vaċċin huwa emulsjoni (taħlita ta ’ likwidi b’ bażi ta ’ żejt u likwidi b’ bażi ta ’ ilma) għall- injezzjoni.
What is Netvax used for?
Għalxiex jintuża Netvax?
Netvax is used to vaccinate chickens against necrotic enteritis caused by C. perfringens type A, so that they pass their immunity against the disease on to their chicks.
Netvax jintuża għat- tilqim tat- tiġieġ kontra enterite nekrotika kkawżata minn C. perfringens tat- tip A, sabiex dawn jgħaddu l- immunità tagħhom kontra din il- marda lill- flieles tagħhom.
Necrotising enteritis is a disease that causes damage to the gut.
L- enterite nekrotizzanti hija marda li tikkawża ħsara lill- intestin.
Birds with the disease fail to thrive.
It- tjur li jkollhom din il- marda ma jgħixux.
Netvax is used to reduce the number of deaths, and the incidence and severity of the disease.
Netvax jintuża sabiex inaqqas l- għadd ta ’ mwiet, u l- inċidenza u s- severità tal- marda.
Netvax is given by injection into the breast muscle.
Netvax jingħata permezz ta ’ titqiba fil- muskolu tas- sider.
The vaccination schedule consists of two doses: the first dose is given at 10 to 14 weeks of age, and then a second dose is given four to 10 weeks after the first.
L- iskeda tat- tilqim tikkonsisti f’ żewġ dożi: l - ewwel doża tingħata meta t- tiġieġ ikollhom minn 10 sa 14- il ġimgħa, u mbagħad it- tieni doża tingħata minn erba’ sa 10 ġimgħat wara l- ewwel waħda.
This second dose should be given at least six weeks before the hen will start to lay eggs.
Din it- tieni doża għandha tingħata mill- inqas sitt ġimgħat qabel it- tiġieġa tibda tbid il- bajd.
The hen can continue to pass on immunity to her chicks for almost a year after the end of vaccination.
It- tiġieġa tista ’ tkompli tgħaddi l- immunità lill- flieles tagħha għal kważi sena wara li tintemm it- tilqima.
How does Netvax work?
Kif jaħdem Netvax?
Netvax is a vaccine.
Netvax huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal - ġisem) kif tħares lilha nnifisha kontra l- mard.
Netvax contains small amounts of a toxoid from C. perfringens type A.
Netvax fih ammonti żgħar ta ’ tossojde minn C. perfringens tat- tip A.
When it is given to a chicken, its immune system recognises the toxoid as ‘ foreign’ and makes antibodies against it.
Meta jingħata lil tiġieġa, is- sistema immunitarja tagħha tagħraf it- tossojde bħala ‘ barrani ’ u toħloq antikorpi kontrih.
The antibodies are transferred from the chicken to the chicks via the eggs.
L- antikorpi jiġu trasferiti mit- tiġieġa għall- flieles minn ġol - bajd.
These antibodies help the chicks to fight necrotic enteritis caused by C. perfringens type A if they are exposed to the bacterium after they have hatched.
L- antikorpi jgħinu lill- flieles jiġġieldu l- enterite nekrotika kkawżata minn C. perfringens tat - tip A jekk ikunu esposti għall- batterju wara li jkunu faqqsu.
Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid.
Netvax fih tip wieħed tat- tossojde minn C. perfringens imsejjaħ it- tossojde alfa.
The vaccine also contains an ‘ adjuvant’ (mineral oil) to stimulate a better response.
Il- vaċċin fih ukoll ‘ aġġuvant ’ (żejt minerali) sabiex jistimula rispons aħjar.
How has Netvax been studied?
Kif ġie studjat Netvax?
The effectiveness of Netvax has been studied in several trials under laboratory and field conditions in chickens and their chicks.
L- effikaċja ta ’ Netvax ġiet studjata f’ bosta provi taħt kundizzjonijiet tal- laboratorju u fil- prattika fit - tiġieġ u l- flieles tagħhom.
The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens’ blood and in their eggs.
Il- miżura ewlenija tal- effikaċja kienet il- produzzjoni ta ’ antikorpi protettivi kontra C. perfringens tat- tip A fid- demm tat- tiġieġ u fil- bajd tagħhom.
The studies compared chickens vaccinated with Netvax with birds that did not receive the vaccine.
L- istudji qabblu tiġieġ imlaqqma b’ Netvax ma ’ tjur li ma rċevewx il- vaċċin.
The studies also looked at death rates in the chicks hatched by vaccinated hens, and at the incidence and the severity of lesions caused by necrotic enteritis in the gut after the chicks were deliberately infected with the bacterium at three weeks of age.
L- istudji ħarsu wkoll lejn ir- rati ta ’ mwiet fil - flieles imfaqqsa minn tiġieġ imlaqqma, u lejn l- inċidenza u s- severità tal- leżjonijiet ikkawżati minn
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. enterite nekrotika fl- intestin wara li l- flieles ikunu ġew infettati intenzjonalment bil- batterju meta dawn kellhom tliet ġimgħat.
What benefit has Netvax shown during the studies?
Liema benefiċċju wera Netvax waqt l- istudji mwettqa?
The studies showed that the vaccine is effective in stimulating the production of antibodies in chickens and in their eggs.
L- istudji wrew li l- vaċċin huwa effettiv fl- istimular tal- produzzjoni ta ’ antikorpi fit- tiġieġ u fil- bajd tagħhom.
The vaccine was well tolerated by the chickens, with no effect on the production of eggs or chicks.
Il- vaċċin kien ittollerat sew mit- tiġieġ, mingħajr l- ebda effett fuq il- produzzjoni ta ’ bajd jew ta ’ flieles.
In chicks hatched from vaccinated hens, the vaccine reduced the number of deaths, and the incidence and the severity of lesions caused by necrotic enteritis.
Fil- flieles li faqqsu minn tiġieġ imlaqqma, il- vaċċin naqqas l- għadd ta ’ mwiet, u l- inċidenza u s - severità tal- leżjonijiet ikkawżati minn enterite nekrotika.
The vaccine protected the chicks during the early period of life, when they are at greatest risk of the disease.
Il- vaċċin ipproteġa lill- flieles matul il - perijodu bikri ta ’ ħajjithom, meta l- aktar li jkunu f’ riskju li jimirdu.
What is the risk associated with Netvax?
X’ inhu r- riskju assoċjat ma ’ Netvax?
Vaccination causes swelling at the site of injection.
It- tilqima tikkawża nefħa fil- post fejn issir it- titqiba.
Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.
In- nefħa wara l- ewwel tilqima normalment titlaq fi żmien 30 jum, u tista ’ ddum mill- inqas 35 jum wara t- tieni tilqima.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għall- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt mal- annimal?
Accidental injection of Netvax can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
Titqiba aċċidentali b’ Netvax tista ’ tikkawża wġigħ kbir u nefħa, l - aktar jekk jiġi injettat aċċidentalment f’ ġog jew saba ’.
If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor.
Jekk tittaqqab aċċidentalment, ħu parir mediku bla telf ta ’ żmien u uri l- fuljett ta ’ tagħrif lit- tabib.
If pain persists for more than 12 hours after examination, seek medical advice again.
Jekk l- uġigħ jibqa ’ jinħass għal aktar minn 12- il siegħa wara l- viżta, erġa ’ ħu parir mediku.
The withdrawal period is zero days.
Il- perijodu ta ’ tiżmim huwa xejn.
Why has Netvax been approved?
Għaliex ġie approvat Netvax?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Netvax exceed the risks for the active immunisation of chickens, to provide passive immunisation against necrotic enteritis to their progeny, during the laying period, to reduce mortality and the incidence and severity of lesions caused by C. perfringens type A-induced necrotic enteritis.
Il- Kumitat għal Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Netvax huma akbar mir- riskji għat- tilqim attiv tat- tiġieġ, għall- għoti ta ’ immunità passiva kontra l - enterite nekrotika lill- wild tagħhom, waqt il- perijodu li fih ikunu qed ibidu, għat- tnaqqis tal- mortalità u tal- inċidenza u s- severità tal- leżjonijiet ikkawżati minn enterite nekrotika kkaġunata minn C. perfringens tat- tip A.
The CVMP recommended that Netvax should be given a marketing authorisation.
Is- CVMP rrakkomanda li Netvax għandu jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Netvax:
Informazzjoni oħra dwar Netvax:
The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B. V. on 16 April 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE għal Netvax lil Intervet International B. V. fil- 16 ta ’ April 2009.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ il- pakkett ta ’ barra.
This summary was last updated on 16 April 2009.
Dan is- sommarju ġie aġġornat l- aħħar fil- 16 ta ’ April 2009.
Invented Strength Name
Għamla farmaċewtika
Pharmaceutical Form
Speċi li fuqhom Metodu jintuża il- prodott ta’ amministrazzjoni
Target species
Ipakkjar
Route of administration
Kontenut
Packaging
Daqs tal - pakett
Content Package size
Perjodu ta ’ tiżmim
Withdrawal period
Flixkun high density
Netvax
Mhux anqas
Not less than 6.8 IU* per dose
Emulsjoni għall - Tiġieġ
Emulsion for injection
Użu intramuskolari
High density polyethylene bottle with chlorobutyl rubber stopper and aluminium seal
polyethylene b’ tapp tal -
Zero days
injezzjoni
6 bottles
6 fliexken Xejn Granet
* International units per ml of rabbit serum determined by haemolysis inhibition assay
* Unitajiet internazzjonali għall- kull ml ta’ serum tal- fenek kif determinat minn assay tal - inħibizzjoni tal- ħimolżi
Netvax emulsion for injection for chickens
Netvax emulsjoni għall- injezzjoni għat- tiġieġ
One dose (0.5ml) contains:
Doża waħda (0. 5mL) fiha:
Active substance:
Sustanzi Attivi:
Clostridium perfringens Type A alpha toxoid
Toksojd Clostridium perfringens tip A alpha
Light Mineral Oil
Mhux inqas minn 6. 8 IU *
0.31 ml
Żejt minerali ħafif 0. 31ml
Excipients
Ingredjenti oħra:
Thiomersal
Tajomersal
Emulsion for injection Off white oily emulsion.
Emulsjoni għall- injezzjoni Emulsjoni żejtnija kanella ċar ħafna
For the active immunization of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period.
Għall- immunita` attiva fit- tiġieġ biex tipprovdi immunita` passiva kontra l - enterite’ nekrotika lill - flieles tagħhom, waqt il- perjodu tat- tqegħied il- bajd.
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis.
Biex tnaqqas l- imwiet u l- inċidenza u s- severita` ta ’ selħiet tal- enterite` nekrotika ikkawżati minn Clostridium perfringens tip A.
Efficacy was demonstrated by challenge of chicks approximately three weeks after hatching.
L- effikaċja ġiet murijha b`challenge fil- flieles madwar tlett ġimgħat wara li faqqsu.
The onset of passive transfer of immunity:
It- trasferiment passiv ta’ immunita` jintlaħaq:
6 weeks following completion of the vaccination procedure
6 ġimgħat wara li titlesta l- proċedura ta’ vaċċinazzjoni
The duration of passive transfer of immunity:
It- trasferiment passiv ta’ immunita` idum:
51 weeks following completion of the vaccination procedure
51 gimgħa wara li tkun lesta l- proċedura ta’ vaċċinazzjoni
2 4.4 Special warnings
4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott >
Special precautions for use in animals None
Prekawzjonijiet speċjali għall- użu fl- annimali
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, speċjalment jekk tinjetta f' ġog jew subgħa u f' kazijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tingħatax għajnuna medika 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 njettat bi żball b' dan il- prodott, fittex għajnuna medika mal- ewwel, anke jekk ġie njettat ammont żgħir ħafna, u ħu l- fuljett 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 'fittex parir mediku.
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 'tikkawza 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 jew it- tendin tal- muskolu.
No systemic reactions to vaccination were seen following intramuscular vaccination.
L- ebda rejazzjoni sistemika għall- vaċċinazzjoni ma’ ġiet osservata wara injezzjoni fil- muskolu.
Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days.
Il- vaċċinazzjoni tista`twassal għal nefħa moderata fis sidra li tinżel fi żmien 30 ġurnata.
Following the second vaccination swelling may persist for at least 35 days.
Wara t- tieni vaċċinazzjoni in- nefħa tista`ddum sa 35 ġurnata.
Swelling was very common.
Nefħiet kienu komuni ħafna.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib u fi żmien il- bajd
The vaccine is safe for use in laying and breeding birds.
Il- vaċċin ma jagħmilx ħsara fit- tjur waqt żmien il- bajd u fi żmien it - tgħammir
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar kemm dan il- vaċċin jaqbel ma kwalunkwe prodott mediċinali veterinarju.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis
Id- deċiżjoni sabiex tintuża din it- tilqima qabel jew wara xi prodott mediċinali veterinarju ieħor, għaldaqstant għandha tittieħed każ b’ każ.
One dose of 0.5 ml should be given at 10 to 14 weeks of age.
Laqqam it- tiġieġ fil- muskolu tas- sider Doża waħda ta’ 0. 5ml għandha tingħata bejn 10 u l - 14 ġimgħa ta` ħajja.
The second dose should be administered no later than 6 weeks before the onset of lay.
It- tieni doża ta’ 0. 5ml għandha tingħata bejn 4 u l - 10 ġimgħa wara l- ewwel vaċċinazzjoni. It- tieni vaċċinazzjoni għandha tingħata mhux aktar tard minn 6 ġimgħat qabel jibdew ibidu.
Syringes and needles must be sterile before use.
Il- labbra u s- siringa jridu jkunu sterili qabel l- użu.
Follow usual aseptic procedures.
Segwi proċeduri asettiċi.
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
(see section 4.6)..
Wara li tingħata doża doppja, reazzjonijiet lokali jistgħu jiżdiedu xi ftit (ara sezzjoni 4. 6)
4.11 Withdrawal period(s)
3 4. 11 Perjodu ta 'Tiżmim
Zero days
Xejn ġranet.
QI01AB08
Immunoloġiċi għat- tjur, Kodici ATĊ veterinarja QI01AB08
To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis.
Biex jistimola l- immunita` attiva fit- tiġieġ sabiex jagħti protezzjoni passiva lill- flieles tagħhom kontra l - enterite` nekrotika ikkawżata minn Clostridium perfringens Tip A.
Light Mineral Oil Thiomersal Formaldehyde Sorbitan oleate Polysorbate 80 Benzyl Alcohol Triethanolamine EDTA Sodium Chloride
Żejt Minerali Ħafif Thiomersal Formalina Sorbitan oleate Polysorbate 80 Benzyl Alcohol Triethanolamine EDTA Melħ (klorid tas- sodjum)
Do not mix with any other veterinary medicinal product.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
Shelf-life after first opening the immediate packaging:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: 18- il xahar Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ:
Use Immediately
Uża mill- ewwel