Summary of medicine characteristics - MS-H Vaccine
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
MS-H Vaccine eye drops suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (30 |d) contains:
Mycoplasma synoviae strain MS-H live attenuated thermosensitive, at least 105.7 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 PARTICULARS4.1 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
4.4 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.
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 in the flock is normally by way of the rapid serum agglutination test (RSAT) with blood samples being tested within 24 hours of collection.
The vaccine strain can spread from vaccinated to unvaccinated birds, including wild species. This may occur during the whole life of the vaccinated bird. Special precautions should be taken to avoid spreading of the vaccine strain to other bird species.
The vaccine strain can be detected in respiratory tract of the chickens until 55 weeks after vaccination.
Distinguishing between field strains and the vaccine strain of M. synoviae can be performed by Hammond classification or High Resolution Melt (HRM) testing by a laboratory.
Infection with M. synoviae induces a transient positive antibody response to Mycoplasma gallisepticum. Although no data are available on the matter, it is likely that vaccination with this product will also induce a positive antibody response to Mycoplasma gallisepticum and may therefore interfere with the serological monitoring of Mycoplasma gallisepticum. If necessary, further differentiation of the 2 Mycoplasma species can be done by using PCR in a laboratory. Samples that can be used for PCR include swabs taken from pathological sites such as trachea, palatine cleft, air sacs or joints.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To avoid skin and eye injuries which may occur by manipulating the frozen bottle, personal protective equipment consisting of gloves and safety glasses should be worn.
If vaccine is accidentally splashed into the operator’s eyes, the eyes and face should be thoroughly washed with water to avoid any potential reaction to culture medium constituents.
4.6 Adverse reactions (frequency and seriousness)
None
4.7 Use during pregnancy, lactation or lay
Do not use in birds in lay and within 5 weeks before the onset of the laying period.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
4.9 Amounts to be administered and administration route
Ocular use.
Chickens from 5 weeks of age
One dose of 30 pl to be administered by eye drop.
Thaw the unopened bottle rapidly between 33–35°C for a time period of 10 minutes in a thermostatic water bath. Do not thaw at higher temperatures or for longer time periods. Use at room temperature (22–27°C) within 2 hours after thawing. Mix the contents of the bottle by gentle agitation during thawing. Invert the bottle repeatedly following thawing to ensure the content has been resuspended. Remove the aluminium seal and rubber stopper before using a plastic dropper tip or other administration device. Use calibrated dropper or device, so as to distribute 30 pl drop of vaccine. Avoid introduction of contamination.
Hold the bird with its head tilted to one side. Invert the dropper bottle or prepare the device allowing a single drop to form at the tip and fall freely into the open eye, gently flooding it. The drop (before release) and tip should not touch the eye surface.
Allow the bird to blink before releasing it.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions have been noted following an 8-fold overdose.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Aves, live bacterial vaccines ATCvet code: QI01AE03
The vaccine induces an active immunity against Mycoplasma synoviae in chickens.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Modified Frey’s medium containing phenol red and swine serum.
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Shelf life after thawing and first opening the immediate packaging: 2 hours.
6.4. Special precautions for storage
Store frozen below –70°C for a maximum of 4 years.
After removal from the deep freeze, further short term storage is allowed at or below –18°C for no more than 4 weeks. Vaccine should not be stored back in –70°C after storage at or below –18°C.
Protect from direct sunlight.
6.5 Nature and composition of immediate packaging
Plastic LDPE bottle of 30 ml (1,000 doses) with butyl rubber stopper sealed with an aluminium cap.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Pharmsure Veterinary Products Europe Limited
4 Fitzwilliam Terrace
Strand Road
Bray
WICKLOW
A98 T6H6
Ireland
8. MARKETING AUTHORISATION NUMBER
EU/2/11/126/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14/06/2011
Date of last renewal: 17/05/2016
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency.