ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1
1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MS-H Vaccine eyedrops suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:
One dose (30 µl) contains:
Mycoplasma synoviae Strain MS-H live attenuated thermosensitive, at least 105.7 CCU*

* Colour Changing Units

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Eyedrops suspension
Red orange to straw translucent suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens from 5 weeks of age (future layer breeder chickens, future broiler breeder chickens and
future layer 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 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

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.

2
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.

No effect on respiratory clinical signs, systemic colonisation and vertical transmission has been
demonstrated.

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 is able to spread from vaccinated to unvaccinated birds, including wild species.
This may occur for the life of the vaccinated bird. Appropriate biosecurity measures should be put in
place to avoid any spread 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 commercial 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 commercial 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, protective 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)

No adverse reactions have been observed after the administration of an 8-fold overdose.

4.7 Use during pregnancy, lactation or lay

Do not use in birds in lay or 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

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Ocular use.
Chickens from 5 weeks of age
One dose of 30l to be administered by eyedrop.

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 µl 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

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group {group}, ATCvet code : QI01AE03

The vaccine induces an active immunity against Mycoplasma synoviae.

4
6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Modified Frey’s medium containing swine serum.

6.2 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 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

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved

for use by the competent authorities.

7. MARKETING AUTHORISATION HOLDER

Pharmsure Ltd
Bewell House
Bewell St, Hereford HR4 0BA
United Kingdom

8. MARKETING AUTHORISATION NUMBER

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

{DD/MM/YYYY}…

5
10 DATE OF REVISION OF THE TEXT

{MM/YYYY}

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

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 ANNEX II

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING

AUTHORISATION REGARDING SUPPLY OR USE

C. CONDITIONS OR RESTRICTIONS OF THE MARKETING

AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE

D. STATEMENT OF THE MRLs

7
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE

Name and address of the manufacturer of the biological active substance

Glenorie Manufacturing Facility

Bioproperties Pty Ltd
11-13 Moores Rd, Glenorie, NSW, 2157
Australia

Name and address of the manufacturer responsible for batch release

Pharmsure Ltd
Unit 9, Moorlands Trading Estate, Moor Lane, Metheringham
Lincolnshire, LN4 3HX
United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION

REGARDING SUPPLY OR USE

To be supplied only on veterinary prescription.

C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH

REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT

Not applicable.

D. STATEMENT OF THE MRLs

The active substance being a principle of biological origin intended to produce active immunity is not
within the scope of Regulation (EC) No 470/2009.

The components of the excipient listed in section 6.1 of the SPC are either allowed substances for
which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are
required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used
as in this veterinary medicinal product.

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 ANNEX III

LABELLING AND PACKAGE LEAFLET

9
A. LABELLING

10
NOTE: There is no outer carton

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LDPE BOTTLE 30 ml LABEL

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MS-H Vaccine eyedrops suspension

M. synoviae Strain MS-H

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

1000 doses

4. ROUTE OF ADMINISTRATION

Ocular use

5. WITHDRAWAL PERIOD

6. BATCH NUMBER

Batch{number}

7. EXPIRY DATE

EXP {month/year}

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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B. PACKAGE LEAFLET

12
 PACKAGE LEAFLET FOR:
MS-H Vaccine eyedrops 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 Ltd
Bewell House
Bewell St, Hereford HR4 0BA
United Kingdom

Manufacturer for the batch release:

Pharmsure Ltd
Unit 9, Moorlands Trading Estate
Moor Lane, Metheringham
Lincolnshire, LN4 3HX
United Kingdom

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

MS-H Vaccine eyedrops suspension

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

One dose (30 µl) contains:

Mycoplasma synoviae Strain MS-H live at least 105.7 CCU*

*Colour Changing Units

Other ingredients:
Modified Frey's medium containing swine serum

4. INDICATION

For vaccination of future broiler breeder chickens, future layer breeder chickens and future layer
chickens to reduce air sac lesions 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

5. CONTRAINDICATIONS

None.

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6. ADVERSE REACTIONS

No adverse reactions have been observed after the administration of an 8-fold overdose.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.

7. TARGET SPECIES

Chickens from 5 weeks of age (Future layer replacement chickens, future broiler breeder chickens
and future layer chickens).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Chickens should be vaccinated once by 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 eyedrop.
 Thaw unopened vials 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 contents
have 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 µl 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.

10. WITHDRAWAL PERIOD

Zero days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

The MS-H vaccine should always be protected from direct sunlight. Store frozen below -70°C for
maximum 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. Once thawed, use within 2 hours.

Do not use after the expiry date which is stated on the label.

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12. SPECIAL WARNING(S)

i Special precautions for use in animals

Do not use in birds in lay or within 5 weeks before the onset of the laying period. Vaccinate all birds
in a flock at the same time.
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 non mycoplasma activity,
such as penicillin, amoxycillin or neomycin. They should not be given within 2 weeks after
vaccination.

No effect on respiratory clinical signs, systemic colonisation and vertical transmission has been
demonstrated.

 Only flocks with no antibodies to MS (M.synoviae) should be vaccinated. Vaccination should be

carried out on MS-free birds at least 4 weeks before expected exposure to virulent MS.
 Pullets should first be tested for MS infection.
 The vaccine strain is able to spread from vaccinated to unvaccinated birds, including wild species.
This may occur for the life of the vaccinated bird. Appropriate biosecurity measures should be
put in place to avoid any spread to other bird species.
 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 commercial 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 commercial
laboratory. Samples that can be used for PCR include swabs taken from pathological sites such
as trachea, palatine cleft, air sacs or joints.
 The vaccine strain can be detected in respiratory tract of the chickens until 55 weeks after
vaccination.
 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 decided on a case-by-case basis.
 Do not mix with any other veterinary medicinal product.

ii Special precautions for the person administering the veterinary medicinal product to
animals
 To avoid skin and eye injuries which may occur by manipulating the frozen bottle, protective
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.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant

approved for this use by the competent authorities.

15
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/.

15. OTHER INFORMATION

Plastic LDPE bottle of 30 ml with butyl rubber stopper and sealed with an aluminium cap.

MAH Number:

To be supplied only on veterinary prescription.

16