qanastek/EMEA-V3 huggingface dataset:
The vaccine should preferably be dissolved in distilled water or alternatively in cool, clean water.
Il- vaċċin għandu preferibilment ikun imdewweb f’ ilma distillat jew ilma frisk u nadif.
The appropriate number of vials should be opened under water.
Numru adattat ta ’ kunjetti għandhom jiġu miftuħa taħt l- ilma.
The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens.
Il- volum tal- ilma għar- rikostituzzjoni għandu jkun biżżejjed sabiex jassigura distribuzzjoni uniformi meta dan jiġi sprejjat fuq it- tiġieġ.
This will vary according to the age of the chickens being vaccinated and the management system, but 250 to 400 ml of water per 1 000 doses is suggested.
Dan ivarja skond l- eta ’ tat - tiġieġ jew flieles u s- sistema li qed tintuża għat- trobbija, iżda bejn 250 – 400 ml ta ’ ilma għal kull elf doża huwa rakkomandabbli.
The vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when the chickens are sitting together in dim light.
L- aħjar li tisprejja huwa huwa meta t- tiġieġ qegħdin miġbura taħt dawl bati.
The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only.
L - apparat tal- bexx għandu jkun nadif u ma fihx frak, ġnub mikula jew traċċi ta ’ xi disinfettant u idealment għandu jintuża għalhekk biss.
Use cool, clean water to dissolve the vaccine.
3/ 18 Fl- ilma tax- xorb Il - kunjetti għandhom jiġu miftuħa taħt l- ilma. uża ilma frisk u nadif sabiex iddewweb il- vaċċin.
For administration of the vaccine, as a general rule, dissolve 1 000 doses in one litre per age in days up to a maximum volume of 20 litres per 1 000 doses.
Bħala reġola ġenerali biex tamministra l- vaċċin dewweb 1000 doża f ’ litru ilma għal kull gurnata żmien li jkollhom il- flieles sa massimu ta ’ 20 litru għal 1000 doża.
For heavy breeds, or in hot weather, the quantity of water may be increased up to 40 litres per 1 000 doses.
Għal razez kbar jew f’ kundizzjonit klimatiċi sħan dan l - ammont jista jitla sa 40 litru għal kull elf doża.
By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer.
Jekk wieħed iżid 2 grammi ta ’ trab tal- ħalib xkumat, jew 20 ml ħalib likwidu xkumat għal kull litru ta ’ ilma, il - virus idum attiv għal aktar ħin.
Ensure that all the vaccine suspension is consumed within 1-2 hours.
Assigura li s- suspensjoni tal- vaċċin ġiet ikkunsmata kollha fi żmien 1- 2 sigħat.
The vaccine should be given in the early morning as this is the main period of water intake or during the cool period on a hot day.
Il - vaċċin għandu jingħata filgħodu kmieni billi dan huwa l- ħin li jinxtorob l- aktar ilma jew fil- ħin li tiffriska l- arja meta tkun ġurnata sħuna.
Water should be withheld before vaccination to make the chickens thirsty.
It- tiġieġ għandu jkollhom l- ikel meta tivvaċċina, iżda wieħed għandu jwaqqaf l - ilma għal xi ħin biex b’ hekk it - tiġieġ jaqbadhom l - għatx u jixorbu.
The length of time of water deprivation is strongly dependent on the climatological
Il- ħin bl - ilma magħluq jiddependi ħafna fuq il - kundizzjoniet klimatiċi.
Water withholding should be kept as short as possible with a minimum of half an hour.
L- ilma għandu jkun magħluq għall- inqas ħin possibli iżda mhux inqas minn nofs siegħa.
A sufficient number of water containers to provide adequate drinking space is essential.
Huwa neċessarju li wieħed jagħmel numru suffiċjenti ta ’ kontenituri bl- ilma sabiex ikun hemm spazju adegwat għax- xorb.
These should be clean and free from traces of detergents and disinfectants.
Dawn il- kontenituri għandhom ikunu nodfa u mingħajr traċċi ta ’ deterġenti u disinfettanti.
Turn on mains water when all the vaccine water has been consumed.
Erġa iftaħ is- sors tal- ilma wara li l- ilma bil- vaċċin jiġi kkunsmat.
Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1 000 doses, 75 ml per 2 500 doses) and administer by means of a standardized dropper.
Amministrazzjoni fl- imnieħer / fl- għajnejn Dewweb il - vaċċin f ’ salina fiżjoloġika jew ilma distillat (ġeneralment 30 ml / 1000 doża jew 75 ml / 2500 doża) u amministra permezz ta ’ qattara tajba.
One drop should be applied onto one nostril or one eye.
Taqtira waħda għandha titpoġġa ġo toqba tal- waħda tal - imnifsejn jew fuq għajn waħda.
Ensure that the nasal drop is inhaled before freeing the bird.
Qabel teħles l- għasfur, aċċerta ruħek li l- qattra fl- imnifsejn ġiet meħuda.
Ocular/ intranasal administration or coarse spray, give the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Amministrazzjoni fl- għajnejn / imnieħer jew permezz ta ’ sprej oħxon, jagħtu l- aħjar rispons u dawn il - metodi għandhom ikunu preferuti, speċjalment meta jitlaqqmu flieles żgħar.
Vaccination programme:
Programm tat- tilqim:
The veterinarian should determine the optimum vaccination schedule according to the local situation.
Il- veterinarju għandu jfassal l- aħjar skeda tat- tilqim skont iċ- ċirkustanzi lokali.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta emergenza, antidot), jekk ikun hemm bzonn
Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration.
Ġie muri li sa 10 darbiet id- doża massima ma kienx ta ’ periklu għas- saħħa tal- ispeċi li għalihom hu ndikat il- prodott, bil- modi kollha rakkomandati.
QI01AD07.
QI01ADO7
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Immunita attiva kontra l - virus tat- tjur tal- Bronkite Infettiva strain IB 4- 91 li jikkawża bronkite infettiva fit- tiġieġ.
Sorbitol, gelatine, pancreatic digest of casein, disodium phosphate, water for injections
Sorbitol, ġelatina, id- diġest pankrejatiku tal- kasejn, fosfat tad- disodju, ilma għall- injezzjoni.
6.2 Incompatibilities
4/ 18 6. 2 Inkompatibilitajiet
Do not mix with any other medicinal product..
Tħallatx ma ebda prodott ieħor.
In freeze-dried form:
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
9 months at 2°C to 8°C.
9 xhur f’ temperatura ta ’ 2oĊ – 8oĊ Fil- forma xotta u ffriżata:
After reconstitution:
Wara li jithallat:
The vaccine should be used within 2 hours.
Il- vaċċin għandu jintuża fi żmien sagħtejn
Store at 2-8°C.
Aħzen f' temperatura ta '2°Ċ – 8°Ċ.
4/ 17 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
A 10 ml vial of Type II hydrolytic glass containing 500, 1 000, 2 500, 5 000 or 10 000 doses of freeze- dried vaccine.
Kunjett ta ’ 10 ml magħmul minn ħġieġ idrolitiku (Tip 2) li fih 500, 1000, 2500, 10 000 dożi tal- vaċċin f’ forma xotta u ffriżata.
The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.
Il- kunjett hu magħluq b’ tapp tal- lastiku tat- tip halogenobutyl rubber u ssiġillat b’ kappa tal- aluminjum b’ kodiċi fuqha.
The product is presented as a single vial or in multipacks of 10 vials of the same dosage.
Il- prodott hu ppreżentat bħala kunjett wieħed jew f’ pakketti ta ’ għaxar kunjetti tal - istess doża.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha jistgħu jitpoġġew fuq is- suq.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials, derived from the use of such products
6. 6 Prewkazzjonijiet speċjali għar- rimi ta’ prodotti veterinarji mhux użati jew skart ieħor magħmul mill- użu ta ’ dawn il- prodotti.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin u dak li mess mal- vaċċin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat u approvat mill- Awtorita Kompetenti tal- pajjiż.
Wim de Körverstraat 35 5831 AN BOXMEER The Netherlands
Wim de Korverstraat 35 5831 AN Boxmeer Olanda.
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA 'AWTORIZZAZZJONI TAL- KUMMERĊ
9 June 1998
9 ta ’ Ġunju1998
PROHIBITION OF SALE, SUPPLY AND/ OR USE
5/ 18 PROJBIZZJONI TA 'BEJGĦ, PROVVISTA U / JEW UŻU
The import, sale, supply and/ or use of Nobilis IB 4-91 is/ or may be prohibited in certain Member States on the whole or part of its territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'Nobilis IB 4- 91 huwa pprojbit jew jista jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is - saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Nobilis IB 4-91 has to consult the relevant Member State’ s competent authorities on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża Nobilis IB 4- 91 għandha tikkonsulta mal- Awtorita Kompetenti tal- Pajjiz Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tissupplixxi jew tuża.
5/ 17 ANNEX II
6/ 18 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA TAS- SUSTANZA BIOLOĠIKA ATTIVA( I) U SID TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance(s)
Isem u indirizz tal- manufattur tas- sustanza( i) bioloġika attiva
CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU
Veterinary Medicinal product subject to medical prescription.
Prodott Veterinarju li jiġi mogħtija biss bi preskrizzjoni veterinarja
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA U/ JEW UŻU
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, Member States prohibit or may prohibit the import, sale, supply and/ or use of Nobilis IB 4-91 on the whole or part of their territory if it is established that: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Skont l- Artiklu 71 tad- Direttiva 2001/ 82/ EC tal- Parlament Ewropew u l- kunsill tal- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, bejgħ, provvista u / jew l- użu ta 'Nobilis IB 4- 91 fit - territorju kollu jew ġo parti mit- territorju tagħhom jekk jiġi stabbilit li: a) l- amministrazzjoni lill- annimali tal- prodott veterinarju jfixkel it- twettiq ta’ programm nazzjonali ta ’ dijanjosi, kontroll u eradikazzjoni ta ’ mard tal- annimali, jew joħloq diffikultajiet biex jiġi aċċertat in- nuqqas ta’ kontaminazzjoni fl- annimali ħajjin jew fi prodotti tal- ikel jew prodotti oħra magħmula minn annimali trattati. b) Il- marda li l- prodott veterinarju huwa intenzjonat li jipprovdi immunita` kontriha hija assenti mit - territorju.
7/ 17 ANNEX III
8/ 18 ANNESS III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Live attenuated Infectious Bronchitis Virus strain 4-91 ≥ 3.6 log10 EID50. *
Virus ħaj imma modifikat tal- Bronkite Infettiva (IBV) variant strain 4- 91: > 3. 6 log10 EID50 *
* EID50 = 50% Embryo infective dose
* EID = 50% tad- doża infettiva għal embriju
1 x 500/ 1000/ 2500/ 5000/ 10000 doses 10 x 500/ 1000/ 2500/ 5000/ 10000 doses
1 x 500/ 1000/ 2500/ 5000/ 10 000, dożi 10 x 500/ 1000/ 2500/ 5000/ 10 000, dożi
TARGET SPECIES
SPEĊI LI L- PRODOTT GĦANDU JINTUŻA FUQHOM
Chickens.
Tiġieġ.
Vaccine against avian Infectious Bronchitis
Tilqima kontra Bronkite Infettiva tat- tjur.
METHOD AND ROUTES OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI
For intranasal/ ocular, spray or drinking water administration.
Amministrazzjoni fl - imnieħer / għajnejn, sprej jew fl- ilma tax - xorb.
10/ 17 10.
11/ 18 9.
{month/ year}
{xahar / sena}
Protect from light.
Aħżen f' temperatura ta '2°Ċ – 8°Ċ.
Do not freeze.
Iprotteġi mid- dawl. Tiffriżax.
Read package leaflet before use.
Aqra l- fuljett tal- informazzjoni qabel tuża.
For animal treatment only – to be supplied only on veterinary prescription.
Għat- Trattament tal- annimali biss – jingħata biss fuq preskrizzjoni ta’ veterinarju.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
NUMRU( I) FIR- REĠISTRU TA’ PRODOTTI MEDIĊINALI FIL- KOMUNITA
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ZGĦAR
QUANTITY OF ACTIVE SUBSTANCE
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
> 3.6 log10 EID50 IBV per dose
> 3. 6 log10 EID50 IBV kull doża
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BIL - PIŻ, VOLUM JEW NUMRU TA 'DOZI
500/ 1000/ 2500/ 5000/ 10000 doses
500/ 1000/ 2500/ 5000/ 10 000 dożi
ROUTES OF ADMINISTRATION
MOD TA 'AMMINISTRAZZJONI
intranasal/ ocular, spray or drinking water
Fl - imnieħer / għajnejn, sprej jew fl- ilma tax - xorb.
Zero days
Perjodu ta 'Tiżmim: xejn ġranet
BATCH NUMBER.
NUMRU TAL- LOTT
EXP.
Jiskadi
13/ 17 PACKAGE LEAFLET FOR:
FULJETT TA 'TAGĦRIF
Nobilis IB4-91, lyophilisate for suspension
14/ 18 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Nobilis IB4- 91, lajofiliżejt għal suspensjoni
Marketing authorisation holder and manufacturer:
Sid tal- Awtorizzazzjoni tal- Kummerċ u tal- manifattura:
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Korverstraat 35 5831 AN Boxmeer Olanda
Live attenuated Infectious Bronchitis Virus variant strain 4-91 ≥ 3.6 log10 EID50. *
Virus ħaj imma modifikat tal- Bronkite Infettiva (IBV) variant strain 4- 91: > 3. 6 log10 EID50 *
* EID50 = 50% Embryo infective dose: the titre required to infect 50% of the embryos inoculated with the virus.
* EID = 50% tad- doża infettiva għal embriju: it- tajter tal- virus li jipproduċi nfezzjoni f’ 50% tal- embriji mlaqqma.
Future layers and breeders should not be vaccinated before 3 weeks of age.
Tiġieġ tal- bajd jew tar- razza m’ għandhomx jieġu mlaqqma qabel ma jkollhom tliet ġimgħat.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
Meta jingħata Nobilis IB 4- 91 ta ’ ġurnata, jista ’ jaffetwa ħażin l- effikaċja tal - vaċċin ta ’ rinotrakeite (TRT) fid- dundjani li jkun ingħata fi żmien ġimgħa u għaldaqstant din l- iskema ta ’ vaċċinazzjoni hija kontraindikata.
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs which may persist for a few days depending on the health and condition of the chickens.
Vaċċinazzjoni b ’ Nobilis IB 4- 91 jista ’ joħloq sintomi respiratorji ħfief tal- marda li jistgħu jippersistu għal xi ftit ġranet skond is- saħħa u l- kundizzjoni tal- flieles.
14/ 17 8.
8.
For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Għal immunita fit- tul, it- tiġieġ għandhom jiġu vaċċinati kull 6 ġimgħat wara l- ewwel amministrazzjoni.
The appropriate number of vials should be opened under the water.
Numru adattat ta ’ kunjetti għandhom jiġu miftuħa taħt l- ilma.
Use cool, clean water to dissolve the vaccine.
Fl- ilma tax- xorb Il - kunjetti għandhom jiġu miftuħa taħt l- ilma. uża ilma frisk u nadif sabiex iddewweb il- vaċċin.
Ensure that all the vaccine suspension is consumed within 1-2 hours.
Assigura li s- suspensjoni tal- vaċċin ġiet ikkunsmata kollha fi żmien sagħtejn.
The length of time of water deprivation is strongly dependent on the climatological circumstances.
Il- ħin bl - ilma magħluq jiddependi ħafna fuq il - kundizzjoniet klimatiċi.
Turn on mains water when all the vaccine water has been consumed.
Erġa` iftaħ is- sors tal- ilma wara li l- ilma bil- vaċċin jiġi kkunsmat.
Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1 000 doses, 75 ml per 2 500 doses) and administer by means of a standardized dropper.
Amministrazzjoni fl- imnieħer/ għajnejn Dewweb il - vaċċin f ’ salina fiżjoloġika jew ilma distillat (ġeneralment 30 ml / 1000 doża jew 75 ml / 2500 doża) u amministra permezz ta ’ qattara tajba.
Ocular/ intranasal administration or coarse spray give the best responses and these should be the methods of choice, especially when vaccinating young chickens.
16/ 18 Amministrazzjoni fl- għajnejn / imnieħer jew permezz ta ’ sprej oħxon, jagħtu l- aħjar rispons u dawn il - metodi għandhom ikunu preferuti, speċjalment meta jitlaqqmu flieles żgħar.
Since the stability of IBV in suspension may be low due to sensitivity to high temperatures and impurities, water used for dissolving the freeze-dried vaccine should be cool and of good quality.
Minħabba li l- istabbilita ta ’ IBV fis- suspensjoni tista ’ tkun baxxa minħabba sensittivita għal temperaturi għolja jew impuritajiet, l- ilma użat sabiex idewweb il- vaċċin xott u ffriżat, għandu jkun frisk u ta ’ kwalita tajba.
By adding skimmed milk to the drinking water the vaccine virus retains its activity longer.
Meta żżid ħalib xkumat mal- ilma tax- xorb, tkun qed ittawwal il- ħin tal- attivita tal- virus fil- vaċċin.
Only skimmed milk should be used, since fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.
Għandek tuża biss ħalib xkumat minħabba li x- xaħam fil - ħalib mhux xkumat jista ’ jimblokkas- sistemi awtomatiċi tax- xorb minbarra li jnaqqas l- effikaċja tal- virus fil- vaċċin.
15/ 17 Only healthy chickens should be vaccinated.
Tiġieġ b’ saħħithom biss għandhom jitlaqqmu.
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
Nobilis IB 4- 91 huwa ntenzjonat li jipproteġi l- flieles kontra sinjali respiratorji tal- marda kkawżata minn IBV variant strain 4- 91 biss u għaldaqstant m’ għandux jintuża minflok tilqim ieħor tal- IBV.
Chickens should be vaccinated against other prevalent IBV serotypes (e. g.
It- tiġieġ għandhom jiġu mlaqqma kontra serjotipi oħra ta ’ IBV (e. ż.
Massachusetts) according to the local IB vaccination programme.
Massachusetts) skond il- programm ta ’ tilqim lokali kontra l- IB.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Il- prodott għandu jintuża biss wara li kien stabbilit li Nobilis variant strain IB 4- 91 huwa epidjemjoloġikament relevanti fl- akkwata.
Do not mix or administer with other products.
Tħallatx jew tagħtix ma prodotti oħra.
Wash and disinfect hands and equipment after vaccinating.
Aħsel u iddisinfetta jdejk u l- għodda wara li tivvaċċina.
Zero days.
xejn ġranet.
Store at 2-8°C.
Aħżen u f' temperatura ta '2°Ċ – 8°Ċ.
Protect from light.
Ipproteġi mid - dawl.
The vaccine should be used within 2 hours after reconstitution and should not be stored.
It- tilqima għanda tintuża fi żmien 2 wara li titħallat u magħndiex tinħażen.
Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration.
17/ 18 Ġie muri li sa 10 darbiet id- doża massima ma kienx ta ’ periklu għas- saħħa tal- ispeċi li għalihom hu ndikat il- prodott, bil- modi kollha rakkomandati.
Care should be taken to avoid spread of a vaccine virus from vaccinated chickens to pheasants.
Il- virus tal- vaċċin jista` jinfirex minn tiġieġ mlaqqma għal dawk li mhumiex għalhekk wieħed għandu jifred dawk imlaqqma minn dawk li mhumiex. Wieħed għandu joqgħod attent li l - virus tal- vaċċin ma jinfirixx minn tiġieġ imlaqqma għal faġani.
DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL- PAKKETT
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Immunita attiva kontra l - virus tat- tjur tal- Bronkite Infettiva ikkawżata mil Infectious Bronchitis virus strain 4- 91 li jikkawża bronkite infettiva fit- tiġieġ.
For animal treatment only.
Għall- trattament ta ’ annimali biss.
1/ 10 x 500/ 1000/ 2500/ 5000/ 10000 doses Not all pack sizes my be marketed.
1/ 10 x 500/ 1000/ 2500/ 5000/ 10 000, dożi Mhux id- daqsijiet tal- paketti kollha jistgħu jitpoġġew fuq is- suq.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għall- kull informazzjoni oħra fuq dan il- prodott veterinarju, ikkuntatja ir- rapreżentant lokali tas- Sid Tal - Awtorizzazzjoni tal- Kummerċ.
What is Nobivac Bb?
X’ inhu Nobivac Bb?
Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Nobivac Bb hu vaċċin li jkun fiħ il- batterju ħaj Bordetella bronchiseptica tar- razza B- C2.
Nobivac Bb is a dry substance and solvent that are made up into a suspension, which is given via the nose.
Nobivac Bb jikkonsisti minn sustanza xotta u solvent li jitħalltu biex jiffurmaw sospensjoni għall- injezzjoni li tingħata mill- imnieħer.
What is Nobivac Bb used for?
Għal x’ hiex jintuża Nobivac Bb?
Nobivac Bb is used to vaccinate cats aged one month or older against the disease (a flu-like illness) caused by the bacterium B. bronchiseptica.
Nobivac Bb jintuża fit- tlaqqim ta ’ qtates, li jkollhom xahar jew iktar, kontra l- marda (li tixbah lill- influwenza) ikkawżata mill- batterju B. bronchiseptica.
Cats are vaccinated by giving a 0.2-ml dose into one nostril.
Il- qtates jitlaqqmu billi jingħataw doża ta ’ 0. 2 ml f’ toqba waħda ta ’ l- imnieħer.
Immunity against infection is usually established after around three days and lasts for up to a year.
L- immunità kontra l- infezzjoni ġeneralment tiġi stabbilita wara madwar tlett ijiem u ddum sa sena.
How does Nobivac Bb work?
Kif jaħdem Nobivac Bb?
Nobivac Bb is a vaccine.
Nobivac Piro hu tilqima.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
It- tilqimiet jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiża naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2.
Nobivac Bb ikun fih tip ta ’ B. bronchiseptica ħaj magħruf bħala razza B- C2.
When a cat is given the vaccine, the immune system recognises the bacteria as ‘ foreign’ and makes a special type of antibodies against them.
Meta qattus jingħata t- tilqima, is- sistema immunitarja tagħraf lill- batterju bħala ‘ barrani ’ u tagħmel tip speċjali ta ’ antikorpi kontrihom.
In the future, the immune system will be able to produce these antibodies more quickly when it is again exposed to the bacteria.
Fil- ġejjieni, is- sistema immunitarja tkun tista ’ tipproduċi dawn l- antikorpi iktar malajr meta terġa ’ tkun esposta għal darba oħra għall- batterju.
The live bacterium strain included in Nobivac Bb differs from other types of B. bronchiseptica because it is missing certain molecules and is therefore less likely to cause disease.
Ir- razza ta ’ batterju ħaj inkluża f’ Nobivac Bb tvarja minn tipi oħra ta ’ B. bronchiseptica għax ma fihiex ċerti molekoli u għalhekk ikun inqas probabbli li tikkawża l- mard.
This makes it suitable for use in a vaccine.
Dan jagħmilha tajba għall- użu f’ vaċċin.
Vaccines against B. bronchiseptica that are administered through the nose are also used in dogs.
Il- vaċċini kontra B. bronchiseptica li jiġu amministrati mill- imnieħer jintużaw ukoll fil- klieb.
(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 Nobivac Bb 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 Nobivac Bb?
The effectiveness of Nobivac Bb was investigated in three main studies involving cats of various breeds.
L- effikaċja ta ’ Nobivac Bb kienet investigata fi tliet studji ewlenin li fihom ħadu qtates ta ’ diversi razez.
The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica.
Il- qtates li tlaqqmu b’ Nobivac Bb qabel ma ġew esposti għal B. bronchiseptica.
Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.
Nobivac Bb kien l- ewwel vaċċin b’ B. bronchiseptica ħaj liċenzjat għall- użu fil- qtates.
What benefit has Nobivac Bb shown during the studies?
X’ benefiċċji ta ’ Nobivac Bb ntwerew f’ dawn l- istudji?
The main studies showed that Nobivac Bb was effective in reducing the symptoms caused by B. bronchiseptica.
L- istudji ewlenin urew li Nobivac Bb kien effettiv fit- tnaqqis tas- sintomi kkawżati mill - B. bronchiseptica.
What is the risk associated with Nobivac Bb?
X’ inhu r- riskju assoċjat ma ’ Nobivac Bb?
Occasional side effects include sneezing, coughing and a mild and temporary discharge from the eyes or nose.
Effetti sekondarji okkażjonali jinkludu l- għatis, is- sogħla u tnixxija ħafifa mill- għajnejn jew l - imnieħer.
In animals that show more severe signs, treatment with an antibiotic may be necessary.
L- annimal li jkollhom sinjali iktar severi, jista ’ jkollhom bżonn trattament b’ antibijotiku.
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 tiġi f’ kuntatt ma ’ l- annimal?
The vaccine may be administered by veterinarians only.
Il- vaċċin għandu jingħata biss minn veterinarji.
In case of accidental administration to people seek medical advice immediately and show the Package Leaflet or label to the doctor.
Il- Fuljett ta ’ Tagħrif jew it- tikketta għandhom jintwerew lit- tabib.
Although the risk for people with weak immune systems becoming infected with B. bronchiseptica is extremely low, it is advised that cats which are in close contact with such people are not vaccinated with Nobivac Bb, since they can shed the bacteria intermittently for up to a year after vaccination.
Għalkemm ir- riskju li nies b’ sistemi immunitarji baxxi jinfettaw ruħom b ’ B. bronchiseptica huwa wieħed baxx ħafna, huwa rakkomandat li l- qtates li jkunu f’ kuntatt mill- qrib ma ’ dawn in- nies ma jitlaqqmux b’ Nobivac Bb, għax dawn jistgħu jnixxu l- batterji kull tant ħin sa sena wara t- tilqim.
Why has Nobivac Bb been approved?
Għaliex ġie aprovat Nobivac Bb?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Bb exceed the risks of its use.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċju ta ’ Nobivac Piro huwa ikbar mir- riskju ta ’ l- użu tiegħu.
Other information about Nobivac Bb:
Tagħrif ieħor dwar Nobivac Bb:
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B. V. on 10 September 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Nobivac Bb lil Intervet International B. V. fl- 10 ta ’ Settembru 2002.
The marketing authorisation was renewed on 25 September 2007.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 25 ta ’ Settembru 2007.
This summary was last updated on 25 September 2007.
Dan is- sommarju ġie aġġornat l- aħħar fil- 25 ta ’ Awwissu 2007.
Invented Name
Saħħa
Strength
Speċi li
Pharmaceutical Target species Form
Ippakkjar
Route of administration
Daqs tal- pakkett
Packaging
Żmien ta ’ Tiżmim
Content
ivvintat
Package size
Farmaċewtika
Withdrawal period
fuqhom t’ amministraz jintuża l - zjoni prodott
≥ 106.3 and ≤ 108..3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
Nobivac ≥ 106. 3 u ≤ 108. 3 Bb ta ’ partijiet li jiffurmaw kolonji
Powder and solvent for suspension for nasal administration
Trab u solvent għal suspensjoni għal
Nasal use
Qtates Għal użu fl - imnifsejn
Powder: vial (glass) Solvent: vial (glass)
Trab: kunjett (ħġieġ) Solvent:
0.5 ml
Doża 5 waħda Solvent:
5 vials 5 vials
0. 5
Not Applicable
Mhux Applikabbli
Nobivac Bb for cats
Nobivac Bb għal qtates
Active substance ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2, per 0.2 ml dose of reconstituted suspension.
Sustanza Attiva: ≥ 106. 3 u ≤ 108. 3 ta ’ partijiet li jiffurmaw kolonji (PJK) tal- batterja ħajja Bordatella bronchiseptica strejn B- C2, f’ kull 0. 2ml ta ’ suspensjoni rokostitwita.
Solvent Water for injections
Solvent Ilma għal injezzjoni
For a list of excipients, see section 6.1.
Ingredjenti mhux attivi Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara sezzjoni 6. 1.
Lyophilisate and solvent for suspension for nasal administration.
Lajofiliżejt u solvent għal suspensjoni għal amministrazzjoni mill- imnifsejn.
Cats.
Qtates
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu u speċifikazzjoni ta ’ l- ispeċi li fuqhom se jintuża l- prodott.
For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Għal immunizzazzjoni attiva fi qtates ta ’ xahar jew aktar, sabiex jitnaqqsu s- sinjali kliniċi ta ’ mard fil - parti ta ’ fuq tas- sistema respiratorja assoċjat ma Bordetella bronchiseptica.
Onset of immunity:
Bidu tal- immunita:
Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Il- bidu tal- immunita ġie stabbilit fi qtates ta ’ tmien ġimgħat, sa minn 72 siegħa wara t- tilqima.
The duration of immunity is up to 1 year.
Kemm iddum l- immunita: l- immunita ddum sa sena.
No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available.
M’ hemmx informazzjoni dwar l- influwenza li anti- korpi tal- omm jista ’ jkollhom fuq l- effett tat- tilqima b’ Nobivac Bb għal qtates.
From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Fil- letteratura huwa kkunsidrat li dan it- tilqim intranasali kapaċi jinduċi rispons ta ’ immunizzazzjoni mingħajr interferenza minn antikorpi ġejjin mill- omm.
4.3 Contra-indications
4. 3 Kontra indikazzjonijiet
If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.
Jekk jiġi amministrat xi antibijotiku fi żmien ġimgħa mit- tilqima, it- tilqima għandha terġa ’ tingħata wara li t- trattament bl- antibijotiku jkun tlesta.
Vaccinated animals can spread the Bordetella bronchispetica vaccine strain for six weeks; in individual cases for at least one year.
Annimali mlaqqma jistgħu ixerrdu l- istrejn tal- vaċċin Bordetella bronchiseptica għal sitt ġimgħat; uħud mill- każijiet anke għal minn tal- inqas sena.
Intermittent spreading is possible as well.
Huwa possibli wkoll li t- tixrid jieqaf u wara ftit jerġa jkompli.
2 4.5 Special precaution(s) for use
4. 5 Prekawzjonijiet Speċjali għall- Użu 2 Prekawzjonijiet speċjali għall- użu fl- annimali
Only healthy cats should be vaccinated.
Qtates b’ saħħithom biss għandhom jiġu mlaqqma.
Sneezing by cats after administration does not adversely affect the efficacy of the product.
Għatis mill- qtates wara l- amministrazzjoni, ma jaffetwax b’ mod kuntrarju l- effikaċja tal- prodott.
Do not administer during antibiotic treatment or in conjunction with any other intranasal products.
Tużax waqt trattament b’ antibijotiċi jew flimkien ma prodotti oħra li jintużaw fl- imnifsejn.
Vaccinated animals can spread the vaccine strain of Bordetella bronchiseptica for six weeks, and there may be intermittent shedding for at least one year.
Annimali vaċċinati jistgħu ixerrdu l- istrejn tal- vaċċin tal- Bordetella bronchiseptica sa sitt ġimgħat, u jista ’ jkun hemm tixrid li jieqaf u jerġa jibda għal mill- inqas sena.
Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats, which are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Għalkemm ir- riskju li nies b’ immunita dgħajfa jiġu nfettati bil- Bordetella bronchiseptica huwa estremament baxx, huwa tal- parir li qtates f’ kuntatt qrib ma nies bħal dawn ma jigux imlaqqma.
Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs.
Klieb, qżieqeż u qtates mhux imlaqqma jistgħu jirreaġixxu għall- istrejn tat- tilqima b’ sinjali respiratorji dgħajfa u li jmorru.
Other animals, such as rabbits and small rodents, have not been tested.
Annimali oħra bħal fniek u rodentiċi oħra żgħar, ma ġewx ittestjati.
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ ta 'amministrazzjoni lilek innifsek b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- fuljett ta' informazzjoni li jkun hemm ġewwa jew it- tikketta ta ’ fuq il- pakkett.
Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
Għandhom jiġu użati proċeduri ta ’ disinfezzjoni flokhom, wara l- użu ta ’ dan it- tilqim li fih batterja ħajja.
Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica is extremely low, such individuals should be aware that cats can shed the organism for up to 1 year after vaccination.
Għalkemm ir- riskju li nies b’ immunita dgħajfa, jiġu nfettati bil- Bordetella bronchiseptica huwa estremament baxx, dawn l- individwi għandhom ikunu jafu li qtates imlaqqma jistgħu ixerrdu l- mikrobu sa sena wara t- tilqima.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose.
Kultant għatis, sogħla u għal ftit żmien, ftit tnixxija mill- għajnejn jew l- imnieħer.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
F’ annimali li juru sinjali aktar gravi, jista ’ jkun indikat trattament adattat b’ antibijotiku.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib u waqt il- bajd
Do not use in pregnant or lactating queens.
Tużax fi qtates nisa waqt it- tqala jew fi żmien li qed jagħtu l- ħalib.
No information is available on the safety and efficacy from the 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 tilqima oħra.
It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with the product.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fi żmien 14 – il jum qabel jew wara li tlaqqam b' dan il- prodott.
Vaccination scheme:
Skema ta ’ vaċcinazzjoni:
One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
Għandha tingħata doża waħda, ta ’ 0. 2ml tal- vaċċin rikostitwit tal- anqas 72 siegħa qabel il- perjodu li fih huwa maħsub li jkun hemm riskju.
Allow the solvent to reach room temperature (15 - 25°C).
3 Ħalli s- solvent jilħaq it- temperatura tal- kamra (15 – 25oC).
Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
B’ mod asettiku ħallat il- vaċċin imnixxef u ffriżat ma 0. 3ml tas- solvent sterili pprovdut.
Shake well after addition of the solvent.
Ħawwad tajjeb wara li żżid is- solvent.
Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat’ s nostrils.
Iġbed 0. 2ml ta ’ vaċċin imħallat ġewwa siringa ta ’ millilitru jew żewġ millilitri, neħħi l- labbra u amministra l- kontenut kollu tas- siringa f’ waħda mill- imnifsejn tal- qattus.
3 The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is forced to breathe through its nostrils.
Ir- ras tal- qattus għandha tinżamm bl- imnieħer jipponta l- fuq u l- ħalq magħluq, sabiex ikun sfurzat jieħu n- nifs minn imnifsejh.
Place the syringe in front of one of the nostrils and carefully administer the whole contents of the syringe into the nasal cavity via this nostril.
Poġġi s- siringa quddiem waħda mill- imnifsejn u b’ attenzjoni amministra l - kontenut kollu tas- siringa fil- kavita nasali via l- imnifsejn.
The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.
Il- vaċċin huwa amministrat direttament mit - tarf tas- siringa għal fuq it- toqba tal- imnifsejn u jidħol fil- kavita nasali waqt li jittieħed in- nifs.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose, particularly in very young susceptible kittens.
Kultant għatis, sogħla u għal ftit żmien, ftit tnixxija mill- għajnejn jew l- imnieħer, partikularment fi qtates suxxettibbli ta ’ eta ’ żgħira ħafna.
To stimulate active immunity against Bordetella bronchiseptica.
Sabiex tkun stimulata immunita attiva kontra Bordetella bronchiseptica.
QI 06AE02.
Kodici ATĊ veterinarja QI 06AE02
Gelatin, sorbitol, phosphate buffers.
Ġelatina, sorbitol u baffers tal- fosfat.
In the absence of incompatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.
Fin- nuqqas ta ’ studji dwar kompattibilita, tħallatx dan il- prodott mediċinali veterinarju ma prodotti oħra ħlief is- solvent provdut għall- użu mal- vaċċin.
Store at 2 - 8°C.
Aħżen fil- friġġ (2°C – 8°C).
One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent.
Kunjett wieħed ta ’ 3ml, li jkun fih ammont ta ’ lajofiliżejt għal doża, (magħmul minn ħġieġ Tip I) ssiġillat b’ tapp tal- gomma u kappa tal- aluminjum, flimkien ma kunjett (ta ’ ħġieġ Tip I) b’ 0. 5ml ta ’ solvent sterili.
5 unit-dose vials of lyophilisate and 5 vials of solvent per carton.
5 kunjetti li jkun fihom ammont ta ’ lajofiliżejt għal doża, u 5 kunjetti ta ’ solvent f’ kull pakkett.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Dispose of waste material that has had contact with the active substance by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi l- materjal ħażin li ġie f’ kuntatt mas- sustanza attiva billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant approvat mill- Awtoritajiet Kompetenti tal- pajjiż.
MARKETING AUTHORISATION HOLDER
IS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Olanda.
10-09-2002
10/ 09/ 2002
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 mediċinali veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
The import, sale, supply and/ or use of Nobivac Bb for cats is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provista u / jew l- użu ta 'Nobivac Bb għal qtates huwa projbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal - annimali.
Any person intending to import, sell, supply and/ or use Nobivac Bb for cats must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Nobivac Bb għal qtates għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
6 A. < MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U > SID (/ S - SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
Manufacturer of the biological active substance
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
275 South Lake Street, Minnesota 56187, Worthington U. S. A.
275, South Lake Street, Minnesota 56187, Worthington U. S. A.
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju li jiġi mogħti 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 lil Kummissjoni Ewropeja dwar pjanijiet ta ’ kummerċ għall- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
According to Article 71 of Directive 2001/ 82/ EEC Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skond l- Artikolu 71 tad- Direttiva 2001/ 82/ KEE, l- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l - importazzjoni, il- bejgħ, il- forniment u/ jew l- użu tal- prodott mediċinali veterinarju fit- territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- dijanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f ’ annimali ħajjin jew fl- ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Carton label:
{Tikketta tal- pakkett}
Per 0.2 ml dose of reconstituted suspension: ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2.
F’ kull doża 0. 2ml ta ’ suspensjoni rokostitwita: ≥106. 3 u ≤108. 3 ta ’ partijiet li jiffurmaw kolonji tal- batterja ħajja Bordatella bronchiseptica strejn B- C2.
Lyophilisate and solvent for suspension for nasal administration.
Lajofiliżejt u solvent għal suspensjoni għal amministrazzjoni nasali.
Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica.
Vaċċin ħaj kontra mard fil- parti ta ’ fuq tas- sistema respiratorja fil- qtates ikkawżat minn Bordetella bronchiseptica.
For nasal administration.
Għal amministrazzjoni nasali.
Read the package leaflet before use for correct administration, disposal of waste materials and special warnings for immunecompromised humans.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett għal amministrazzjoni korretta, rimi ta ’ materjal ħażin u twissijiet speċjali għal persuni b’ immunita dgħajfa.
Store at 2 - 8°C.
Aħżen f’ temperatura ta ’ 2°C - 8°C.
Lot/ Batch {number}
Lott {numru}
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Label for the vaccine vial:
Tikketta tal- kunjett tal- vaċċin:
≥ 106,3 and ≤ 108,3 CFU/ dose B. bronchiseptica
≥106. 3 u ≤108. 3 ta ’ PJK tal- Bordatella bronchiseptica.
1 dose.
Doża
Nasal administration.
Amministrazzjoni nasali
(not applicable - will not be mentioned)
(mhux applikabbli – mhux se jkun imsemmi)
EXP {month/ year}
JIS {xahar/ sena} >
For animal treatment
Għal Trattament tal- Annimali.
Label for the solvent vial:
Tikketta tal- kunjett tas- solvent:
Solvent for Nobivac Bb
Solvent għal Nobivac Bb
1 dose
Doża
0.5 ml
0. 5ml
See package leaflet
Ara l- fuljett ta ’ tagħrif li jinsab fil- pakkett
15 PACKAGE LEAFLET Nobivac Bb for cats
15 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Nobivac Bb għal qtates
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Wim de Körvertstraat 35 PO Box 31 NL – 5830 AA Boxmeer Olanda
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) AND OTHER INGREDIENT(S)
3 DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Contains ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica strain B-C2, per 0.2 ml dose of reconstituted suspension.
Fiha ≥ 106. 3 u ≤ 108. 3 ta ’ partijiet li jiffurmaw kolonji (PJK) tal- batterja ħajja Bordatella bronchiseptica strejn B- C2, f’ kull doża ta ’ 0. 2ml ta ’ suspensjoni rokostitwita.
For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Għal immunizzazzjoni attiva fi qtates ta ’ xahar jew aktar, sabiex jitnaqqsu s- sinjali kliniċi ta ’ mard fil - parti ta ’ fuq tas- sistema respiratorja assoċjat ma Bordetella bronchiseptica.
The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Il- bidu tal- immunita ġie stabbilit fi qtates ta ’ tmien ġimgħat, sa minn 72 siegħa wara t- tilqima.
The duration of immunity is up to 1 year.
L- immunita ddum sa sena.
CONTRA-INDICATIONS
5 KONTRA- INDIKAZZJONIJIET
Do not use in pregnant or lactating queens.
Tużax fi qtates tqal jew li qed jagħtu l- ħalib
After overdose, identical signs appear particularly in very young susceptible kittens.
Kultant għatis, sogħla u għal ftit żmien, ftit tnixxija mill- għajnejn jew l- imnieħer, partikularment fi qtates suxxettibbli ta ’ eta ’ żgħira ħafna.
The head of the cat should be held with its nose pointing upward and its mouth closed, so that it is forced to breathe through its nostrils.
Ir- ras tal- qattus għandha tinżamm bl- imnieħer jipponta l- fuq u l- ħalq magħluq, sabiex ikun sfurzat jieħu n- nifs minn imnifsejh.
Protect from light.
Aħżen f’ temperatura ta ’ 2oC - 8oC Ipproteġi mid- dawl
Sneezing by cats after administration does not adversely affect the efficacy of the product.
Għatis mil- qtates wara l- amministrazzjoni, ma jaffetwax b’ mod kuntrarju l- effikaċja tal- prodott.
Do not administer during antibiotic treatment, or in conjunction with any other intranasal product.
Tużax waqt trattament b’ antibijotiċi jew flimkien ma prodotti oħra li jintużaw fl- imnifsejn.
If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.
17 Jekk jiġi amministrat xi antibijotiku fi żmien ġimgħa mit- tilqima, it- tilqima għandha terġa ’ tingħata wara li t- trattament bl- antibijotiku jkun tlesta.