MS-H Vaccine
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
03-06-2021
Produktets egenskaber
(SPC)
03-06-2021
Offentlige vurderingsrapport
(PAR)
29-09-2016
Aktiv bestanddel:
Mycoplasma synoviae strain MS-H
Tilgængelig fra:
Pharmsure Veterinary Products Europe Ltd
ATC-kode:
QI01AE03
INN (International Name):
Mycoplasma synoviae (live)
Terapeutisk gruppe:
Chicken
Terapeutisk område:
Immunologicals for aves, Live bacterial vaccines
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 6
Autorisation status:
Authorised
Autorisation dato:
2011-06-14
Indlægsseddel
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
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Produktets egenskaber
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
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