Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Mycoplasma synoviae strain MS-H
Pharmsure Veterinary Products Europe Ltd
QI01AE03
Mycoplasma synoviae (live)
Chicken
Immunologicals for aves, Live bacterial vaccines
For active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.
Revision: 6
Authorised
2011-06-14
11 B. PACKAGE LEAFLET 12 PACKAGE LEAFLET: MS-H VACCINE EYE DROPS SUSPENSION 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Pharmsure Veterinary Products Europe Limited 4 Fitzwilliam Terrace Strand Road Bray WICKLOW A98 T6H6 Ireland Manufacturer responsible for batch release: Laboratoire LCV Z.I. du Plessis Beuscher 35220 Chateaubourg France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT MS-H Vaccine eye drops suspension 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Eye drops, suspension. Red orange to straw translucent suspension. One dose (30 µl) contains: ACTIVE SUBSTANCE: _Mycoplasma synoviae _ strain MS-H live attenuated thermosensitive, at least 10 5.7 CCU* *colour changing units OTHER INGREDIENTS: Modified Frey's medium containing phenol red and swine serum 4. INDICATION(S) For vaccination of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by _Mycoplasma synoviae. _ _ _ Onset of immunity: 4 weeks after vaccination. The animal will be immune for 40 weeks after the vaccination. The duration of immunity to reduce the number of eggs with abnormal shell formation has not yet been demonstrated. 13 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Chickens 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Ocular use. Chickens should be vaccinated once by applying one eye drop (30 µl) from 5 weeks of age and at least 5 weeks before the onset of the laying period. 9. ADVICE ON CORRECT ADMINISTRATION CHICKENS FROM 5 WEEKS OF AGE One dose of 30 l should be administered by eye drop. • Thaw unopened bottles rapidly between 33-35°C for a time period of 10 minu Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MS-H Vaccine eye drops suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: One dose (30 µl) contains: _Mycoplasma synoviae_ strain MS-H live attenuated thermosensitive, at least 10 5.7 CCU* * colour changing units For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Eye drops, suspension. Red orange to straw translucent suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by _Mycoplasma synoviae. _ Onset of immunity: 4 weeks after vaccination. The duration of immunity to reduce air sac lesions has been demonstrated to be 40 weeks post vaccination. The duration of immunity to reduce the number of eggs with abnormal shell formation has not yet been demonstrated 4.3 CONTRAINDICATIONS None. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not use antibiotics with anti-Mycoplasma activity 2 weeks before or 4 weeks after vaccination. Such antibiotics include e.g. tetracycline, tiamulin, tylosin, quinolones, lincospectin, gentamicin or macrolide antibiotics. Where antibiotics must be used, preference should be given to agents with no anti-mycoplasma activity, such as penicillin, amoxicillin or neomycin. They should not be given within 2 weeks after vaccination. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate all birds in a flock at the same time. Only flocks with no antibodies to _M. synoviae _ should be vaccinated. Vaccination should be carried out on _M. synoviae _ -free birds at least 4 weeks before expected exposure to virulent _M. synoviae_ . Pullets should first be tested for _M. synoviae _ infection. Testing for the presence of _M. synoviae Διαβάστε το πλήρες έγγραφο