qanastek/EMEA-V3 huggingface dataset:
Latvija ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Anglija Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
Latvija ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Anglija
42 PACKAGE LEAFLET Aivlosin 8.5 mg/g Premix for medicated feeding stuff
44 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Aivlosin 8. 5 mg/ g Ikel imħallat mal- mediċina minn qabel bil- lest
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs.
Aivlosin 8. 5 mg/ g Ikel imħallat mal- mediċina minn qabel bil- lest għall- qżieqeż.
Magnesium trisilicate, wheat feed flour
Magnesium trisilicate, tqiq ta ’ l- għalf tal- qamħ
Treatment of clinical outbreaks of Swine Dysentery in herds, caused by Brachyspira hyodysenteriae, where the disease has been diagnosed, and prevention of further clinical cases.
Trattament ta ’ mard kliniku mifrux ta ’ Disinterija tal- Qżieqeż fil- merħliet, ikkawżat minn Brachyspira hyodysenteriae, fejn il- marda kienet iddijanjostikata, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
43 5.
45 5.
For treatment and prevention of Swine Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Għall- kura u l- prevenzjoni ta ’ Pnewmonja Enżootika Id- dożaġġ hu ta ’ 2. 125 mg tylvalosin għal kull kilogramm ta ’ piż tal- ġisem kuljum ma ’ l- ikel għal 7 t’ ijiem konsekuttivi.
Duration of treatment
Tul tal - kura
5 kg/tonne*
Rata ta ’ inklużjoni ma ’ l- ikel Aivlosin 8. 5 mg/ g Ikel imħallat minn qabel
Treatment of PPE (ileitis)
Għall- kura u l- prevenzjoni tal- pnewmonja enżootika tal- qżieqeż
4.25 mg/kg bodyweight/day
2. 125 mg/ kg ta ’ 7 ijiem piż tal- ġisem / kuljum
10 days
5kg/ tunnellata *
10
4. 25 mg/ ta ’ piż tal - 10 ijiem ġisem/ kuljum
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product.
Każijiet akuti jew fi qżieqeż morda serjament li qed jieħdu razzjon ta ’ ikel u ilma ristrett, għandhom jiġu kkurati bi prodott adattat li jista ’ jiġi injettat.
44 In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the build up of resistance.
Flimkien mal- mediċina, immaniġġjar tajjeb u prattiċi ta ’ l- iġjene tajbin għandhom jiġu introdotti sabiex inaqqsu r- riskju ta ’ l- infezzjoni u biex jikkontrollaw l- iżvilupp tar- reżistenza.
Pelleting conditions involve a single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70°C under normal conditions.
Kondizzjonijiet għal pellits jinvolvu pass wieħd li jikkondizzjona minn qabel bil- fwar għal 5 minuti u mbagħad isiru il- pellits f’ temperatura ta ’ mhux aktar minn 70°C taħt kondizzjonijiet normali
Store in the original container Do not use after the expiry date stated on the label.
Aħżen fil- kontenitur oriġinali
Meal:
Għalf:
1 month Pellets:
Pellits:
2 weeks
Xahar Ġimgħatejn
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
47 Fil- każ ta ’ bligħ aċċidentali fittex parir mediku immedjatament u uri it- tikketta lit- tabib.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Is- sigurtà ta ’ Aivlosin waqt it- tqala u fi żmien il- ħalib ma kinetx stabbilita fil- qżieqeż.
45 Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Ġeneralment, strejns ta ’ B. hyodysenteriae għandhom valuri tal- MIC ogħla f’ każijiet ta ’ reżistenza kontra makrolidi oħrajn, bħal tilosin.
Česká republika Cymedica spol. sr.o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
48 Česká republika Cymedica spol. sr. o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.
49 Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.
Aivlosin 8.5 mg/g Oral Powder
50 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq
Marketing Authorisation Holder and Manufacturer:
Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ u Manifattur:
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR United Kingdom
Manifattur responsabbli għall- Ħruġ tal- Lott Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR Renju Unit
Aivlosin 8.5 mg/g Oral Powder for pigs
Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq qżieqeż
At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.
Fid- doża rrakkomandata, il - feriti fil- pulmuni u t- tnaqqis fil- piż jitnaqqsu iżda l- infezzjoni b’ Mycoplasma hyopneumoniae ma tkunx eliminata.
Treatment of Porcine Proliferative Enteropathy caused by Lawsonia intracellularis.
Trattament ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (ileite) ikkawżata minn Lawsonia intracellularis.
Treatment of clinical outbreaks of Swine Dysentery in herds, where the disease has been diagnosed, and prevention of further clinical cases.
Trattament ta ’ mard kliniku mifrux ta ’ Disinterija tal- Qżieqeż fil- merħliet, ikkawżat minn Brachyspira hyodysenteriae fejn il- marda kienet iddijanjostikata, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
None known If you notice any side effects, please inform your veterinary surgeon
L- ebda effetti mhux mixtieqa mhuma magħrufa Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
Larger groups should be treated with medicated feeding stuff containing the premix.
Gruppi akbar għandhom jiġu ttrattati b’ għalf medikat li jkun fih l- ikel imħallat mal- mediċina bil- lest.
The oral powder is for use in individual pigs on farms where only a small number of pigs are to receive the medicine.
It- trab li jittieħed mill- ħalq hu għall- użu ta ’ qżieqeż individwali f’ irziezet fejn ikun hemm biss numru żgħir ta 'qżieqeż li jkunu ser jirċievu l- mediċina.
Larger groups should be treated with medicated feeding stuff containing the premix.
Guppi akbar għandhom jiġu kkurati b’ għalf imħallat mal- mediċina li jkun fih it- taħlita lesta diġà.
For treatment and prevention of Swine Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Għall- kura u l- prevenzjoni ta ’ Pnewmonja Enżootika Id- dożaġġ hu ta ’ 2. 125 mg tylvalosin għal kull kilogramm ta ’ piż tal- ġisem kuljum ma ’ l- ikel għal 7 ijiem konsekuttivi.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Għall- kura ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (EPQ) (ileite) Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, mogħti ma ’ l- ikel għal 10 ijiem konsekuttivi.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Għall- kura u l- prevenzjoni tad- Disinterija tal- Qżieqeż Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, mogħti ma ’ l- ikel għal 10 ijiem konsekuttivi.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g Oral Powder into the daily ration for each individual pig.
Dan normalment jinkiseb billi tħallat tajjeb Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq fir- razzjon ta ’ l- għalf ta ’ kuljum għal kull qażquż individwali.
Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8.5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.
Mgħaref ta ’ 3 daqsijiet huma pprovduti biex l - ammont korrett ta ’ Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq jitkejjel biex jitħallat mar- razzjon ta ’ kuljum, skond l- iskeda t’ hawn taħt.
The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
L- ikel li jkun fih it- trab li jittieħed mill- ħalq għandu jkun ipprovdut bħala l- uniku razzjon għal perjodi rakkomandati hawn fuq.
The correct quantity of Aivlosin 8.5 mg/g Oral Powder should then be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed.
Il- kwantità korretta ta ’ Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq għandha tiżdied mal - kwantità stmata tar- razzjon ta ’ kuljum għal kull qażquż, f’ barmil jew f’ xi reċipjent simili, u mħallta sew.
The product should only be added to dry non-pelleted feed.
52 Il- prodott għandu jkun miżjud ma ’ għalf xott li ma jkunx f’ forma ta ’ pellits biss.
Swine Enzootic Pneumonia 2.125 mg/kg bodyweight
Pnewmonja Enżootika tal- Qżieqeż 2. 125 mg/ kg ta ’ piż tal- ġisem
Bodyweight range (kg) 6.5 - 12
6. 5 - 12
1 2 3 4
10 ml
25-48 49-72 73-96
73 - 96
5 6 7 8
3 4 5 6 7 8
50
NB:
NB:
mimlija
A level scoop of the product should be measured
bil- prodott
A level scoop of the product should be measured
Mgħarfa mimlija bil- prodott għandha titkejjel
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product.
Każijiet akuti u qżieqeż morda serjament li jieħdu inqas ikel jew ilma għandhom ikunu ttrattati bi prodott adattat li jista ’ jkun injettat.
In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the potential development of resistance.
Flimkien mal- mediċina, immaniġġjar tajjeb u prattiċi ta ’ l- iġjene tajbin għandhom jiġu introdotti sabiex inaqqsu r- riskju ta ’ l- infezzjoni u biex jikkontrollaw l- iżvilupp tar- reżistenza.
Do not use after the expiry date stated on the label
Tużax wara d- data ta ’ li jiskadi li hemm fuq it- tikketta
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals people with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
Billi Aivlosin intwera li jikkawża reazzjonijiet ta ’ sensittività eċċessiva f’ annimali tal- laboratorju, nies li hu magħruf li għandhom sensittività eċċessiva għal tylvalosin tartrate għandhom jevitaw kull kuntatt mal- prodott.
When adding the veterinary medicinal product to the individual feed ration and when handling this feed, direct contact with eyes, skin and mucous membranes should be avoided.
53 Meta tkun qed iżżid il- prodott mediċinali veterinarju mar- razzjon ta ’ l- għalf individwali u meta tkun qed iġġorr dan il- għalf, kuntatt dirett ma ’ l- għajnejn, ġilda u riti mukużi għandu jkun evitat.
Personal protective equipment should be worn when handling the veterinary medicinal product or the feed with product added: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to EN 143.
Tagħmir personali protettiv għandu jintlibes meta tħallat il- prodott mediċinali veterinarju jew jew meta l- għalf bil- prodott ikun miżjud: owveralls, ingwanti impermeabbli u jew respiratur ta ’ nofs maskla li jikkonforma ma ’ l- Istandard Ewropew EN 149 li tuża u tarmi jew respiratur mhux li tuża u tarmi li jikkonforma ma ’ l- Istandard Ewropew EN 140, b’ filtru skond EN 143.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
Fil- każ ta ’ bligħ aċċidentali fittex parir mediku immedjatament u uri it- tikketta lit- tabib.
Cross-resistance to other macrolide antibiotics cannot be excluded.
Ir- reżistenza inkroċjata għal antibijotiċi makrolidi oħrajn ma tistax tiġi eskluża.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV.
Česká republika Cymedica spol. sr.o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
54 Česká republika Cymedica spol. sr. o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.
55 Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.
54 PACKAGE LEAFLET FOR Aivlosin 625 mg/g Granules for use in drinking water for chickens (attached as concertina label directly to the immediate package)
56 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Aivlosin 625 mg/ g Granuli għal użu fl- ilma tax- xorb għat- tiġieġ (mehmuż bħala tikketta konċertina direttament mal- ippakkjar immedjat)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Marketing Authorisation Holder:
Sid l- Awtorizzazzjoni tal- Kummerċ
Manufacturer for the batch release:
Manifattur li jħalli l- konsenja tmur fis- suq
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR United Kingdom
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR Ir- Renju Unit
Aivlosin 625 mg/g granules for use in drinking water for chickens Tylvalosin (as tylvalosin tartrate)
Aivlosin 625 mg/ g granuli għal użu fl- ilma tax- xorb għat- tiġieġ Tylvalosin (bħala tylvalosin tartrate)
Tylvalosin as tartrate
Tylvalosin bħala tartrejt
Treatment and prevention of respiratory disease associated with Mycoplasma gallisepticum in chickens.
Kura u prevenzjoni ta ’ mard respiratorju marbut ma ’ Mycoplasma gallisepticum fit- tiġieġ
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation.
Bħala għajnuna fi strateġija ta ’ prevenzjoni sabiex jitnaqqsu s- sinjali kliniċi u l- mortalità mill- mard respiratorju fi qtajja ta ’ tjur, meta infezzjoni fl- ovum tal- mara b’ Mycoplasma gallisepticum hija probabbli peress li l- marda hi magħrufa li teżisti fil- ġenerazzjoni tal- ġenituri.
CONTRAINDICATIONS
KONTRA - INDIKAZZJONIJIET
55 6.
57 6.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
For use in drinking water.
Għal użu fl- ilma tax- xorb
For treatment of respiratory disease associated with Mycoplasma gallisepticum The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
Għal kura ta ’ mard respiraturju marbut ma ’ Mycoplasma gallisepticum Id- dożaġġ hu ta ’ 25 mg ta ’ tylvalosin għal kull kg ta ’ piż tal- ġisem kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi.
When used as an aid in the prevention strategy (where infection in ovum with Mycoplasma gallisepticum is likely):
Meta użat bħala għajnuna fi strateġija ta ’ prevenzjoni (meta infezzjoni fl- ovum b’ Mycoplasma gallisepticum hija probabbli):
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at 1 day old.
Id- dożaġġ hu ta ’ 25 mg ta ’ tylvalosin għal kull kg ta ’ piż tal- ġisem kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi sa minn meta jkollhom jum.
This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old).
Dan ikun segwit bit- tieni trattament ta ’ 25mg tylvalosin għal kull kg ta ’ piż tal- ġisem kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi fil- perjodu tar- riskju, i. e fi żmien ta ’ stress kawża tal- immaniġġjar bħall- amministrazzjoni ta ’ vaċċini (tipikament meta t- tjur ikollhom 2- 3 ġimgħat).
Select the correct number of sachets according to the amount of product required.
Iddetermina l- piż kollu (f’ kg) tat- tiġieġ kollha li jkunu se jiġu trattatti Agħżel l- għadd korrett ta ’ qratas skond l- ammont tal- prodott meħtieġ.
One sachet of 40 g is sufficient for a total of 1000 kg of chickens (e.g.
Qartas wieħed ta ’ 40 g huwa biżżejjed biex jittratta 1000 kg ta ’ tiġieġ (e. g.
20,000 birds with an average bodyweight of 50 g).
20, 000 tajra b’ piż tal- ġisem medju ta ’ 50 g).
20 000 birds with an average bodyweight of 500 g).
20, 000 tajra b’ piż tal- ġisem medju ta ’ 500 g).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
Sabiex tikseb id- doża korretta, għandu mnejn ikun meħtieġ il- preparazzjoni ta ’ soluzzjoni konċentrata (stokk) (eż. biex tittratta total ta ’ 500 kg bħala total tal- piż tal- ġisem tat- tjur, 50% biss tas- soluzzjoni stokk magħmula mill- qartas ta ’ 40 g għandha tintuża).
The product should be added to a volume of water that the chickens will consume in one day.
Il- prodott għandu jiġi miżjud ma ’ volum ta ’ ilma li l- flieles ikunu ser jikkunsmaw f’ jum wieħed.
No other source of drinking water should be available during the medication period.
L- ebda sors ieħor ta ’ ilma għax- xorb m’ għandu jkun disponibbli waqt il- perjodu li tkun qed tingħata l - mediċina.
When preparing a stock solution the maximum concentration should be 40 g per 1500 ml or 400 g of product per 15 litres and it is necessary to mix the solution for 10 minutes.
Meta tipprepara s- soluzzjoni stokk, il- konċentrazzjoni massima għandha tkun ta ’ qartas ta ’ 40 g għal kull 1500 ml jew 400 g ta ’ prodott għal kull 15- il litru u hu meħtieġ li tħallat is- soluzzjoni għal 10 minuti.
After this time, any remaining cloudiness will not affect the efficacy of the veterinary medicinal product.
Wara dan il- ħin, is- soluzzjoni mdardra li tibqa ’ m’ għandiex taffettwa l- effikaċja tal- prodott.
2 days Not authorised for use in laying birds producing eggs for human consumption.
Jumejn Mhux permess li jintuża fi tjur tal- bajd li jipproduċu bajd għall- konsum tan- nies.
Opened sachets should not be stored.
Qratas miftuħin m’ għandhomx jinżammu.
Do not use after the expiry date, which stated on the label as “EXP”
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta bħala “ JIS ”.
Shelf-life of the medicated drinking water:
Iż- żmien kemm idum tajjeb l- ilma medikat wara li jitħallat:
24 hours Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
24 siegħa Għandu jiġi preparat biss ammont suffiċjenti ta ’ ilma għax- xorb sabiex ikopri l- ħtiġijiet ta ’ kuljum.
Medicated drinking water should be replaced every 24 hours.
Ilma tax- xorb bil- mediċina għandu jiġi mibdul kull 24 siegħa.
Good management and hygiene practices should be introduced in order to reduce the risk of re- infection.
Immaniġġjar u prattiċi tajbin ta ’ l- iġjene għandhom jiġu introdotti biex jitnaqqas ir- riskju ta ’ infezzjoni mill- ġdid.
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal product.
Tylvalosin intwera li jista ’ jikkawża reazzjonijiet ta ’ sensittività eċċessiva f’ annimali tal- laboratorju; għalhekk persuni li hu magħruf li għandhom sensittività eċċessiva għal tylvalosin tartrejt għandhom jevitaw il- kuntatt mal- prodott mediċinali veterinarju.
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided.
Meta tkun qed tħallat il- prodott mediċinali veterinarju u ġġorr l- ilma bil- mediċina, għandek tevita kuntatt dirett ma ’ l- għajnejn, il- ġilda u l- membrani mukużi.
Personal protective equipment should consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 be worn when mixing the veterinary medicinal product.
Tagħmir protettiv personali għandu jintlibes meta tħallat li jikkonsisti minn ingwanti li ma jgħaddix ilma minnhom u respiratur ta ’ nofs maskra li hu konformi ma ’ l- Istandard Ewropew EN 149, jew respiratur li jista ’ jerġa jintuża li hu konformi ma ’ l- Istandard Ewropew EN 140, flimkien ma ’ filtru konformi ma ’ l- Istandard Ewropew EN 143 għadu jintlibes meta jitħallat il- prodott mediċinali veterinarju.
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: // www. emea. europa. eu /.
57 15.
59 15.
Aivlosin 625 mg/g Granules for use in drinking water for chickens is available in sachets containing 40 g or 400 g.
Aivolson 625 mg/ g granuli għal użu f’ ilma tax- xorb għat- tiġieġ jiġi fi qratas li fihom 40 g jew 400 g.
58 Ελλάδα Καλορίζου Μ.-Σ.Κουρουπίδης ΟΕ Ηρώων Πολυτεχνείου 60 43100 Καρδίτσα Ελλάδα Τηλ: +3024410 41951 Email: info@vkk.gr
60 Ελλάδα Καλορίζου Μ. - Σ. Κουρουπίδης ΟΕ Ηρώων Πολυτεχνείου 60 43100 Καρδίτσα Ελλάδα Τηλ: +3024410 41951 Email: info@ vkk. gr
59 Κύπρος Cycon Chemicals Ltd 5, Promitheos, 1065 Nicosia Κύπρος Τηλ: + 357-22818498 Email: cycon.chemicals@cytanet.com.cy
61 Κύπρος Cycon Chemicals Ltd 5, Promitheos, 1065 Nicosia Κύπρος Τηλ: + 357- 22818498 Email: cycon. chemicals@ cytanet. com. cy
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT EWROPEW TA ’ VALUTAZZJONI PUBBLIKA (EPAR)
BTVPUR ALSAP 8
BTVPUR ALSAP 8 Sommarju tal- EPAR għall- pubbliku
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport Ewropew ta ’ Valutazzjoni Pubblika (EPAR).
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni medika jew il- kura tal- annimali tiegħek ikkuntattja lit - tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tal - CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is BTVPUR AlSap 8?
X’ inhu BTVPUR AlSap 8?
BTVPUR AlSap 8 is a vaccine.
BTVPUR AlSap 8 huwa vaċċin.
It is a suspension for injection that contains inactivated (killed) bluetongue serotype 8 viruses.
Huwa sospensjoni għall- injezzjoni li fiha virusis tal- Bluetongue tas - serotip 8 inattivati (maqtula).
What is BTVPUR AlSap 8 used for?
Għalxiex jintuża BTVPUR AlSap 8?
BTVPUR AlSap 8 is used in cattle and sheep to protect them against bluetongue disease.
BTVPUR AlSap 8 jintuża f’ bovini u nagħaġ biex jipproteġihom kontra l- marda tal- bluetongue.
Bluetongue disease is an infection that is transmitted by midges and caused by the bluetongue virus (serotype 8).
Il - marda tal- bluetongue hija infezzjoni li tiġi trasmessa minn insetti dipteri u hija kkawżata mill- virus tal - bluetongue (serotip 8).
The vaccine is used to limit viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Il- vaċċin jintuża biex inaqqas viremja (il- preżenza ta ’ virusis fid- demm) u jnaqqas is- sinjali tal- marda.
The vaccine is given to young animals as an injection under the skin.
Il- vaċċin jingħata lill- annimali ta ’ età żgħira bħala injezzjoni taħt il- ġilda.
One injection is enough to vaccinate sheep, but cattle will need a second injection three to four weeks later.
Injezzjoni waħda hija biżżejjed biex tlaqqam in- nagħaġ, iżda l- bovini jkunu jeħtieġu injezzjoni oħra tlieta jew erba ’ ġimgħat wara.
The first injection is given at one month of age in animals that have never been exposed to the disease, and at two-and-a- half months if the animal’ s mother is already immune to the disease.
L- ewwel injezzjoni tingħata lill- annimali li qatt ma kienu esposti għall- marda meta jkollhom xahar, u meta jkollhom xahrejn u nofs jekk omm l- annimal tkun diġà immuni għall- marda.
The vaccine will only be used as part of an approved national disease control programme.
Il- vaċċin għandu jintuża biss bħala parti minn programm nazzjonali approvat ta ’ kontroll tal- marda.
This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission
Dan minħabba l- fatt li l- kontroll tal- bluetongue huwa r- responsabbiltà tal- awtoritajiet veterinarji nazzjonali b’ konsultazzjoni mal- Kummissjoni Ewropea.
How does BTVPUR AlSap 8 work?
Kif jaħdem BTVPUR AlSap 8?
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi ruħha kontra l- mard.
BTVPUR AlSap 8 contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
BTVPUR AlSap 8 fih virusis tal- bluetongue inattivati biex ma jkunux jistgħu jikkawżaw il- marda.
When it is given to cattle and sheep, the animals’ immune systems recognise the viruses as ‘ foreign ’ and make antibodies against the virus.
Meta jingħata lill- bovini u lin- nagħaġ, is- sistemi immunitarji tal- annimali jagħrfu l- virusis bħala ‘ barranin ’ u jagħmlu antikorpi kontra l- virus.
In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Aktar ’ il quddiem, jekk l- annimali jkunu esposti għall- virus tal- bluetongue, is- sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
This will help to protect against the disease.
Dan jgħin biex ikun hemm protezzjoni kontra l- marda.
BTVPUR AlSap 8 contains bluetongue viruses of one type (‘ serotype 8’).
BTVPUR AlSap 8 fih virusis tal- bluetongue ta ’ tip wieħed (‘ serotip 8 ’).
The vaccine also contains ‘ adjuvants’ (aluminium hydroxide and saponin) to stimulate a better response.
Il- vaċċin fih ukoll ‘ sustanzi mhux attivi ’ (aluminium hydroxide u saponin) biex jistimulaw reazzjoni aħjar.
How has BTVPUR AlSap 8 been studied?
Kif ġie studjat BTVPUR AlSap 8?
The safety of the vaccine was studied in laboratory safety studies carried out with BTVPUR AlSap 8 in cattle and sheep.
Is- sigurtà tal- vaċċin ġiet studjata permezz ta ’ studji ta ’ sigurtà fil- laboratorju mwettqa b’ BTVPUR AlSap 8 fil- bovini u n- nagħaġ.
Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine is intended for use in an emergency situation.
Ġew ippreżentati wkoll riżultati minn sensiela ta ’ provi ta ’ sigurtà fil - laboratorju imwettqa b’ vaċċini ta ’ kompożizzjoni simili iżda ta ’ serotipi differenti ta ’ bluetongue sabiex jiġu estrapolati konklużjonijiet ta ’ sigurtà, minħabba li l- vaċċin huwa maħsub għall- użu f’ każ ta ’ emerġenza.
The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in cattle from one month of age.
L- effikaċja tal- vaċċin fil- bovini ġiet studjata waqt prova fil- laboratorju bl- użu tal- vaċċin f’ bovini minn xahar ’ il fuq.
Another laboratory study looked at the use of the vaccine in sheep aged three to four months.
Studju ieħor tal- laboratorju ħares lejn l- użu tal- vaċċin f’ nagħaġ ta ’ bejn it- tlieta sa erba ’ xhur.
The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as published information to show how the vaccine will also work in younger sheep.
Il- kumpanija ppreżentat ukoll riżultati minn sensiela ta ’ studji b’ vaċċini oħrajn li fihom serotipi oħrajn tal- virus tal- bluetongue, kif ukoll informazzjoni ppubblikata biex turi kif il- vaċċin jista ’ jaħdem ukoll f’ nagħaġ iżgħar.
The vaccine was assessed in the context of an emergency situation which means that further studies with BTVPUR AlSap 8 are still ongoing and will be assessed.
Il- vaċċin ġie evalwat fil- kuntest ta ’ sitwazzjoni ta ’ emerġenza li jfisser li għadhom għaddejjin studji ulterjuri b’ BTVPUR AlSap 8 u sejrin jiġu evalwati.
What benefit has BTVPUR AlSap 8 shown during the studies?
X’ benefiċċji wera BTVPUR AlSap 8 waqt l- istudji mwettqa?
The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and viraemia in animals from one month of age that are infected with bluetongue virus serotype 8.
L- istudji juru li l- vaċċin huwa sigur għal nagħaġ u bovini u li dan inaqqas is- sinjali tal- marda u viremja f’ annimali minn xahar ’ il fuq li huma nfettati bil- virus tal- bluetongue serotip 8.
The studies also showed that the vaccine can be used in pregnant sheep.
L- istudji wrew ukoll li l- vaċċin jista ’ jintuża f’ nagħaġ tqal.
The safety of the vaccine in pregnant cows is not yet fully established, but results to date show that the vaccine can be used safely at least during the last three months of pregnancy.
Is- sigurtà tal- vaċċin f’ baqar tqal għadha mhix stabbilita sew, iżda r- riżultati sallum juru li l- vaċċin jista ’ jintuża b’ mod sigur għall- inqas matul l- aħħar tliet xhur tat- tqala.
What is the risk associated with BTVPUR AlSap 8?
X’ inhu r- riskju assoċjat ma ’ BTVPUR AlSap 8?
After vaccination, there can be a small swelling at the injection site lasting up to two weeks.
Wara t- tilqima, jista ’ jkun hemm nefħa żgħira fil- post tal- injezzjoni li ddum sa ġimagħtejn.
Animals may also show a temporary increase in body temperature, usually of no more than 1ºC, in the 24 hours after vaccination.
Fl- 24 siegħa ta ’ wara t- tilqima, l- annimali jista ’ jkollhom ukoll żieda temporanja fit- temperatura tal- ġisem, normalment ta ’ mhux aktar minn 1ºC.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm għandu jitħalla żmien qabel l- annimal jinqatel u l- laħam tiegħu jintuża għall- konsum mill- bniedem (perijodu ta ’ tiżmim)?
The withdrawal period for both sheep and cattle is zero days.
Il- perijodu ta ’ tiżmim għan- nagħaġ kif ukoll għall- bovini huwa ta ’ żero jiem.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm għandu jitħalla żmien qabel ma jkun jista ’ jittieħed ħalib mill- annimal għall- konsum mill- bniedem?
Milk can be taken after zero days for both sheep and cattle.
Il- ħalib jista ’ jittieħed minnufih kemm għan- nagħaġ kif ukoll għall- bovini.
Why has BTVPUR AlSap 8 been approved?
Għaliex ġie approvat BTVPUR AlSap 8?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of BTVPUR AlSap 8 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotype 8, and recommended that BTVPUR AlSap 8 should be given a Marketing Authorisation.
Il- Kumitat għal Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ BTVPUR AlSap 8 huma akbar mir- riskji għat- tilqim attiv ta ’ nagħaġ u bovini għall- prevenzjoni ta ’ infezzjoni, viremja u sinjali kliniċi kkawżati mill- virus tal- bluetongue serotip 8, u rrakkomanda li BTVPUR AlSap 8 għandu jingħata Awtorizzazzjoni għat- Tqegħid fis- Suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ benefiċċju- riskju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
BTVPUR AlSap 8 has been authorised under ‘ Exceptional Circumstances’.
BTVPUR AlSap 8 ġie awtorizzat taħt ‘ Ċirkustanzi Eċċezzjonali ’.
This means that it has not been possible to obtain complete information about BTVPUR AlSap 8.
Dan ifisser li ma kienx possibbli li jinġabar it- tagħrif kollu dwar BTVPUR AlSap 8.
Page 2/ 3 Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista ’ jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for BTVPUR Alsap 8?
2/ 3 Liema informazzjoni għadha mistennija għal BTVPUR Alsap 8?
The company that makes BTVPUR Alsap 8 will submit an action plan together with timelines for all of the issues that need to be resolved before the authorisation can revert to normal status.
Il- kumpanija li tipproduċi BTVPUR Alsap 8 sejra tissottometti pjan ta ’ azzjoni flimkien ma ’ perijodi speċifiċi għall- kwistjonijiet kollha li jeħtieġu riżoluzzjoni qabel ma l- awtorizzazzjoni tkun tista ’ tmur lura għall- istatus normali.
It will also supply regular updates on the use and the safety of the vaccine.
Din għandha wkoll tipprovdi aġġornamenti regolari dwar l- użu u s- sigurtà tal- vaċċin.
Other information about BTVPUR Alsap 8:
Informazzjoni oħra dwar BTVPUR Alsap 8:
The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 8 to Merial on 17 March 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE għal BTVPUR AlSap 8 lil Merial fis- 17 ta ’ Marzu 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 jistgħu jinsabu fuq it- tikketta/ il- pakkett ta ’ barra.
This summary was last updated on 17 March 2009.
Dan is- sommarju ġie aġġornat l- aħħar fis- 17 ta ’ Marzu 2009.
Invented name
Speċi li fuqhom
Strength
Mod ta ’
Pharmaceutical Form
Ippakkjar
Target Species
Kontenut
Route of Administration
Perjodu ta ’
Packaging
kummerċjali
Content
Farmaċewtika
Package size
għandu jintuża l- prodott
Withdrawal period
Amministrazzj oni
≥ 7.1 CCID50 *
> 7. 1 CCID50 *
Cattle, Sheep
Bovini, Nagħaġ
Polyproylene bottle with chlorobutyl rubber stopper and aluminium cap
Flixkun tal - polypropylen bi stopper tal - lastku chlorobutyl u tapp tal - aluminju
Box of 1 bottle of 100 doses
Kaxxa ta ’ flixkun ta ’ 100 doża
N/ A (Cattle), N/ A (Sheep)
M/ A (Bovini), M/ A (Nagħaġ)
Box of 10 bottles of 100 doses each
Kaxxa ta ’ 10 M/ A fliexken ta ’ (Bovini), 100 doża il M/ A wieħed (Nagħaġ)
N/ A (Cattle), N/ A (Sheep)
Kaxxa ta ’ M/ A flixkun ta ’ (Bovini), 50 doża M/ A (Nagħaġ)
EU/ 2/ 09/ 094/ 004
1/ 2 EU/ 2/ 09/ 094/ 004
Polyproylene bottle with chlorobutyl rubber stopper and aluminium cap
Flixkun tal - polypropylen ee bi stopper tal- lastku chlorobutyl u tapp tal - aluminju
Box of 10 bottles of 50 doses each
Kaxxa ta ’ 10 M/ A fliexken ta ’ (Bovini), 50 doża il M/ A wieħed (Nagħaġ)
Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
Flixkun tal - ħġieġ ta ’ Tip I bi stopper tal- lastku chlorobutyl u tapp tal - aluminju
N/ A (Cattle), N/ A (Sheep)
Kaxxa ta ’ M/ A flixkun ta ’ (Bovini), 10 dożi M/ A (Nagħaġ)
* Equivalent to titre prior to inactivation (log10)
(*) ekwivalenti għal titru qabel l- inattivazzjoni (log10)
BTVPUR AlSap 8, suspension for injection.
BTVPUR AISap 8 suspensjoni għall- injezzjoni.
Each dose of 1ml of vaccine contains:
Kull doża ta ’ millilitru ta ’ vaċċin fiha:
Active substances:. Bluetongue virus serotype 8 antigen (*) equivalent to titre prior to inactivation (log10)
Antiġen tal- virus tal- Bluetongue tas- serotip 8
≥ 7.1 CCID50*
> 7. 1 CCID50 *
Adjuvants:.
Sustanzi mhux attivi:
Aluminium hydroxide 2.7 mg.
- Aluminium hydroxide - Saponin 30HU **
Saponin 30 HU**(**) Haemolytic units
(** unitajiet emolitiċi)
Excipients:
Ingredjenti oħra:
Sheep and cattle
Nagħaġ u bovini
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8. *(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ ml, indicating no infectious virus transmission )”
Immunizzazzjoni attiva ta ’ nagħaġ u bovini għall - prevenzjoni kontra viremja *, u għat- tnaqqis ta ’ sinjali kliniċi ikkawżati mill- virus tal- bluetongue serotip 8. * taħt il- livell li jista ’ jitkejjel bil- metodu ikkonfermat RT- PCR 3. 14log10 RNA kopji/ ml, li jindika l - ebda trasmissjoni tal- virus infettiv.
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
Il- bidu ta ’ l- immunità ġie muri 3 ġimgħat wara l- ewwel kors ta ’ tilqim.
The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.
It- tul ta ’ l- immunità għadu mhux stabbilit kompletament fil- bovini u fin- nagħaġ, għalkemm ir- riżultati mhux finali ta ’ studji li huma għaddejjin juru li t- tul huwa mill- inqas ta ’ 6 xhur wara l- ewwel kors ta ’ tilqim fin- nagħaġ.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Jekk il- prodott jintuża fi speċi ruminanti oħra domestiċi u slavaġ li huma kkunsidrati f’ riskju ta ’ infezzjoni, l- użu f’ dawn l- ispeċi għandu jsir b’ attenzjoni u huwa rrikmandat li l- vaċċin jiġi ittestjat fuq numru żgħir ta ’ annimali qabel jingħata t- tilqim kollu f’ daqqa.
The level of efficacy for other species may differ from that observed in sheep and cattle.
Il- livell ta ’ effikaċja għal speċi oħra jista ’ jkun differenti minn dak osservat fin- nagħaġ u fil- bovini.
2 4.5 Special precautions for use
2 4. 5 Prekawzjonijiet Speċjali għall- Użu
Vaccinate healthy animals only.
Laqqam biss annimali f’ saħħithom.
None
Xejn.
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days) A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur within 24 hours after vaccination.
Sa ’ 24 siegħa mit- tilqima, jista ’ jkun hemm żieda transitorja fit- temperatura, normalment ta ’ mhux aktar minn medja ta ’ 1. 1ºC.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib u fi żmien l- bajd
Can be used during pregnancy in ewes.
Jista 'jintuża fin- nagħaġ waqt it- tqala.
Safety throughout pregnancy in cows is not yet fully established however interim results demonstrate safety in at least the last trimester of pregnancy in cows.
Is- sigurtà waqt it- tqala fil- baqar għadu ma ġiex kompletament stabbilit iżda r- riżultati waqt studji dwar dan juru sigurtà għall- inqas fl- aħħar terz tat- tqala fil- baqar.
The safety and the efficacy of the vaccine has not been established in breeding males.
Is- sigurtà u l- effikaċja tal- vaċċin għadhom ma ġewx stabbiliti fil- barri tar- refgħa.
In this category of animals the vaccine should be used only according to the benefit/ risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
F’ din il- kategorija ta ’ annimali il- vaċċin għandu jiġi użat biss skond kif il- veterinarju responsabbli u/ jew l- awtoritajiet kompetenti nazzjonali fuq il- programmi kurrenti dwar it- tilqim kontra l- virus tal- Bluetongue (BTV) iqisu il- benefiċċju / riskju tal- prodott.
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra M' hemmx informazzjoni fuq is- sigurtà u l- effikaċja ta ’ dan il- vaċċin meta jintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Għaldaqstant id- deċiżjoni biex jintuża dan il- vaċċin qabel jew wara kwalunkwe prodott mediċinali veterinarju ieħor għandha tittieħed skond il- każ partikolari.
Apply usual aseptic procedures.
Uża l- proċeduri asettiċi tas- soltu.
Shake gently immediately before use.
Ħawwad il- vaċċin bil- mod eżatt qabel l- użu.
Avoid bubble formation, as this can be irritating at the site of injection.
Evita li jiffurmaw bżieżaq, peress li dan jista jikkawża irritazzjoni fil- post tal- injezzjoni.
The entire content of the bottle should be used immediately after broaching and during the same procedure.
Il- kontenut kollu tal- flixkun għandu jintuża immedjatament wara li jinfetaħ u waqt l- istess proċedura.
Avoid multiple vial broaching.
Evita ftuħ ta ’ ħafna fliexken.
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Amministra doża ta ’ millilitru taħt il- ġilda skond din l- iskema li ġejja ta ’ tilqim:
• Primary vaccination In sheep
L- ewwel kors ta ’ tilqim Fin- nagħaġ
- One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
- Injezzjoni waħda: annimali minn xahar, il fuq f’ merħla li qatt ma kellha l- marda (jew f’ annimali
born to immune sheep).
minn ta ’ xahrejn u nofs imwielda minn nagħaġ li jġorru immunita ’).
- 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
Fil- bovini - l- ewwel injezzjoni: f’ annimali minn xahar ‘ il- fuq f ’ merħla li qatt ma kellha l - marda (jew f’ annimali ta ’ xahrejn u nofs ‘ il- fuq imwielda minn bovini li jġorru immunita ’).
- 2nd injection: after 3-4 weeks
It- tieni injezzjoni: wara 3- 4 ġimgħat
3 • Revaccination As the duration of immunity is not yet fully established in cattle or sheep, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
3 Tilqim mill- ġdid Peress li t- tul tal- immunità ghadu m’ hux kompletament stabbilit fil- bovini jew fin- nagħaġ kwalunkwe skema ta ’ tilqim mill- ġdid għandha tkun miftiehma ma l- Awtorita ’ Kompetenti jew il- veterinarju responsabbli wara li tittieħed in konsiderazzjoni is- sitwazzjoni epidemjoloġika lokali.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
L- ebda reazzjoni avversa, ħlief dawk imsemmija fis- sezzjoni 4. 6, ma ntweriet wara li ngħatat doża doppja tat- tilqima.
4.11 Withdrawal period
4. 11 Perjodu ta 'Tiżmim
Zero days.
Xejn.
IMMUNOLOGICAL PROPERTIES
KWALITAJIET IMMUNOLOĠIĊI
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Grupp Farmako- terapewtiku: virus tal- bluetongue serotip 8, Kodiċi ATĊ veterinarja Q104AA02 (nagħaġ) u Q102AA08 (bovini).
The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Il- vaċċin fih il- virus inattivat tal- Bluetongue serotip 8 bis- sustanzi mhux attivi aluminium hydroxide u saponin.
It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Il- vaċċin jinduċi immunità attiva u speċifika kontra l- virus tal- Bluetongue serotip 8 fl - annimal vaċċinat.
Silicon antifoam Phosphate buffer Glycine Buffer
Silicon antifoam Fosfat buffer Glycine buffer
Do not mix with any other veterinary medicinal product.
Tħallatx ma ebda prodott veterinarju mediċinali ieħor.
1 year Shelf life after first opening the immediate packaging: immediately after broaching
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sena Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ il- pakkett ewlieni: immedjatament wara li jinfetaħ
Store and transport refrigerated (2°C – 8°C) Do not freeze Protect from light
Aħżen u ttrasporta ġo friġġ (2°C – 8°C) Tagħmlux fil- friża Ipproteġi mid- dawl
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml)
Flixkun tal- polipropilin ta ’ 50 jew 100 ml bit- tapp tal- lastku Kaxxa ta ’ flixkun wieħed ta ’ 100 doża (1 x 100 ml) Kaxxa ta ’ 10 fliexken ta ’ 100 doża (10 x 100 ml) Kaxxa ta ’ flixkun wieħed ta ’ 50 doża (1 x 50 ml) Kaxxa ta ’ 10 fliexken ta ’ 50 doża (10 x 50 ml)
4 Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml)
4 Flixkun ta ’ tal- ħġieġ Tip 1, ta ’ 10 ml bit- tapp tal- lastku Kaxxa ta ’ flixkun wieħed ta ’ 10 dożi (1 x 10 ml)
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif jitolbu r- regolamenti tal- pajjiż.
MERIAL 29, avenue Tony Garnier 69007 Lyon FRANCE
MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCE
PROHIBITION OF SALE, SUPPLY AND/ OR USE
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
The import, sale, supply and/ or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU L- importazzjoni, bejgħ, provista u / jew l- użu ta 'BTVPUR AISap 8 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 BTVPUR AlSap 8 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 BTVPUR AISap 8 għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
MANUFACTUREROF THE BIOLOGICAL ACTIVE SUBSTANCEAND MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MIS- SID TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manufattur tas- sustanza bioloġika attiva
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
MERIAL Animal Health Limited Biological Laboratory, Ash Road Pirbright, Woking, Surrey GU 24 ONQ United Kingdom
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, 69800 Saint-Priest France
MERIAL Laboratorju ta ’ Lyon Porte des Alpes Rue de l- Aviation 69800 Saint- Priest France
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA JEW L- UŻU