ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
COXEVAC suspension for injection for cattle and goats
2.
Composition for 1 ml:
Active substance:
Inactivated
Coxiella burnetii,
strain Nine Mile 72 QF Unit*
*Q-fever Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference
item.
Excipients:
Thiomersal
max. 120 μg
For a full list of excipients, see section 6.1.
3.
Suspension for injection
4.
4.1
Cattle and goats
4.2
Cattle
For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-
pregnant to become shedder (5-times lower probability in comparision with animals receiving a placebo),
and to reduce shedding of
Coxiella burnetii
in these animals via milk and vaginal mucus.
Onset of immunity: not established.
Duration of immunity: 280 days after completion of the primary vaccination course.
Goats
For the active immunisation of goats to reduce abortion caused by
Coxiella burnetii
and to reduce
shedding of the organism via milk, vaginal mucus, faeces and placenta.
Onset of immunity: not established.
Duration of immunity: not established. Protection has been demonstrated by challenge 8 weeks post-
primary vaccination (see section 4.9)
4.3
None.
4.4
Vaccination of animals already infected at the time of vaccination will have no adverse effect. No efficacy
data are available concerning the use of Coxevac in male animals. However, in safety laboratory trials, the
use of Coxevac in males proved to be safe. In the case that it is decided to vaccinate the whole herd, it is
advisable to vaccinate the male animals at the same time.
2
There are no benefits of the vaccine (as described in the indications for cattle), when used in infected
and/or pregnant cows.
The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
4.5
It is advisable to vaccinate all the animals in the herd at the same time.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet
or the label, to the physician.
Cattle
It is very common (in 8 out of 10 animals) to see a palpable reaction of maximum diameter of 9 to 10 cm
at the injection site, which may last for 17 days. The reaction gradually reduces and disappears without
need for treatment.
Goats:
It is very common (in 4 out of 12 animals) to see a palpable reaction of 3 to 4 cm diameter at the injection
site which may last for 6 days. The reaction reduces and disappears without need for treatment.
It is very common (more than 1 in 10 animals) to observe a slight increase of rectal temperature for 4 days
post-vaccination without other general signs.
In cattle and goats the vaccine is safe to use during lactation.
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
Subcutaneous use.
Shake well before use.
Administer the vaccine as follows:
Cattle: 4ml in the neck region
Goats: 2 ml in the neck region
Although efficacy claim is based on data from challenge test carried out on goats vaccinated twice 6 and 3
weeks before start of pregnancy, there are indications from a large field trial that it is useful to vaccinate
young animals. This information along with data obtained in cattle, allow recommending the following
vaccination program:
Cattle from 3 months of age:
Primary vaccination:
3
Two doses should be given subcutaneously with an interval of 3-weeks. Under normal conditions the
timing of vaccination should be planned so that the primary course is completed by 3 weeks before
artificial insemination or mating.
Re-vaccination:
Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Goat from 3 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3-weeks. Under normal conditions the
timing of vaccination should be planned so that the primary course is completed by 3 weeks before
artificial insemination or mating.
Duration of immunity has not been established. Protection has been demonstrated by challenge 8 weeks
post-primary vaccination.
Cattle
With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site,
lasting for 16 days. The reaction gradually reduced and disappeared without need for treatment.
Goats
With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site,
lasting for 4 days. The reaction reduced and disappeared without need for treatment.
4.11 Withdrawalperiods
Meat, milk and offal: Zero days
5.
Pharmacotherapeutic group: Inactivated bacterial vaccines for cattle, ATCvet code: QI02AB
Pharmacotherapeutic group: Inactivated bacterial vaccines for goat, ATCvet code: QI03AB
The vaccine contains phase I
Coxiella burnetii
as active ingredient inducing active immunity against Q-
fever in cattle and goats.
6.
6.1 List of excipients
Thiomersal
Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
4
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale is 12 months
Shelf-life after first opening the immediate packaging: use within 10 hours
6.4. Special precautions for storage
Store and transport refrigerated (2 C - 8 C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Carton box with 1 plastic (LDPE) bottle, containing 40 ml or 100 ml of solution.
Each container is closed with a 20 mm bromobutyl rubber stopper and a central tear-off aluminium-plastic
cap.
Not all pack sizes may be marketed.
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.
CEVA Sante Animale
10 avenue de la Ballastiere
33500 Libourne, FRANCE
Tel: +33 5 57 55 40 40
Fax: +33 5 57 55 41 98
8.
EU/2/10/110/001-002
9.
30/09/2010
10
30/09/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
5
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of COXEVAC is or may be prohibited in certain Member States on the
whole or part of their territory pursuant to national animal health policy. Any person intending to import,
sell, supply and/or use COXEVAC must consult the relevant Member State’s competent authority on the
current vaccination policies prior to the import, sale, supply and/or use.
6
ANNEX II
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) 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
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
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
CEVA-Phylaxia Veterinary Biologicals Co. Ltd.
1107 Budapest Szállás u. 5.
HUNGARY
Name and address of the manufacturer responsible for batch release
CEVA-Phylaxia Veterinary Biologicals Co. Ltd.
1107 Budapest Szállás u. 5.
HUNGARY
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 in
the scope of Regulation (EC) 470/2009.
The following constituents of Coxevac are included in table 1 of the annex to Commission Regulation (EU)
No 37/2010 as follows:
Pharmacologi-
cally active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other provisions
Therapeutic
classification
Thiomersal
N/a
All food
producing
species
No MRL
required.
N/a
For use only as
preservatives in multidose
vaccines at a concentration
not exceeding 0,02 %.
No entry
All food
producing
species
Sodium chloride N/a
No MRL
required.
N/a
No entry
No entry
Disodium
hydrogen
phosphate
- covered by
entry for food
additives with
an E number (E
339ii)
N/a
All food
producing
species
No MRL
required
N/a
Only substances approved
as additives in foodstuffs
for human consumption,
with the exception of
preservatives listed in part
C of Annex III to European
Parliament and Council
Directive 95/2/EC
No entry
8
Potassium
dihydrogen
phosphate -
covered by entry
for food
additives with
an E number
(E340i)
N/a
All food
producing
species
No MRL
required
N/a
Only substances approved
as additives in foodstuffs
for human consumption,
with the exception of
preservatives listed in part
C of Annex III to European
Parliament and Council
Directive 95/2/EC
No entry
In addition to the above constituents the product contains the following excipient: water for injection. This
excipient is considered as not falling within the scope of Regulation (EC) No 470/2009.
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
An efficacy confirmatory study in goats under laboratory or field conditions should be performed,
establishing a duration of immunity, based on a reduction of abortions and/or a reduction in shedding
(duration, intensity, frequency) in milk (which seems to be the main route of bacterial shedding), and/or
faeces, and/or vaginal excretion. The corresponding claim would then be established in compliance with
the parameters tested, and the results obtained (when satisfactory). This trial should be conceived in a way
showing consistency with the vaccination scheme (time and number of injections, minimum age at
vaccination). The maximum time allowed to prepare the report should be 1 year after the claimed duration
of immunity.
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX for 40 ml plastic bottle, 100 ml plastic bottle
1.
COXEVAC suspension for injection for cattle and goats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Inactivated
Coxiella burnetii,
strain Nine Mile 72 QF Unit* / ml
Thiomersal max. 120 μg
*Q-fever Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference
item.
3.
Suspension for injection
4.
PACKAGE SIZE
40 ml
100 ml
5.
Cattle and goats
6.
Active immunisation to reduce
Coxiella burnetii
shedding.
7.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
Withdrawal period: zero days
12
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP: {month/year}
Once opened, use within 10 hours.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
CEVA Sante Animale
10 avenue de la Ballastiere 33500 Libourne, FRANCE
16. MARKETING AUTHORISATION NUMBERS
EU/2/10/110/001-002
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
13
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
LABEL for 100 ml plastic bottle
1.
COXEVAC suspension for injection for cattle and goats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Inactivated
Coxiella burnetii,
strain Nine Mile
72 QF Unit / ml
3.
Suspension for injection
4.
PACKAGE SIZE
100ml
5.
Cattle and goats.
6.
INDICATION
For active immunisation to reduce Coxiella burnetii shedding.
7.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
Withdrawal period: zero days
9.
SPECIAL WARNING(S), IF NECESSARY
14
Thiomersal
max. 120 μg
10. EXPIRY DATE
EXP: {month/year}
Once opened, use within 10 hours.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
CEVA Sante Animale
10 avenue de la Ballastiere 33500 Libourne, FRANCE
16. MARKETING AUTHORISATION NUMBERS
EU/2/10/110/002
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL for 40 ml plastic bottle
1.
COXEVAC suspension for injection for cattle and goats
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Inactivated
Coxiella burnetii,
strain Nine Mile
72 QF Unit/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
40 ml
4.
ROUTE OF ADMINISTRATION
Subcutaneous use.
5.
Withdrawal period: zero days
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP: {month/year}
Once opened, use within 10 hours.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET FOR:
COXEVAC suspension for injection for cattle and goats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
CEVA Sante Animale
10 avenue de la Ballastiere 33500 Libourne, FRANCE
Manufacturer for the batch release
:
CEVA-Phylaxia Veterinary Biologicals Co. Ltd.
1107 Budapest, Szállás u. 5. HUNGARY
2.
COXEVAC suspension for injection for cattle and goats
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Composition for 1 ml:
Active substance:
Inactivated
Coxiella burnetii,
strain Nine Mile 72 QF Unit*
*Q-fever Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference
item
Excipients:
Thiomersal
max. 120 μg
Clear, brown lacteal suspension.
4.
INDICATIONS
Cattle
For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-
pregnant to become shedder (5-times lower probability in comparision with animals receiving a placebo),
and to reduce shedding of
Coxiella burnetii
in these animals via milk and vaginal mucus.
Onset of immunity: not established.
Duration of immunity: 280 days after completion of the primary vaccination course.
Goats
For the active immunisation of goats to reduce abortion caused by
Coxiella burnetii
and to reduce
shedding of the organism via milk, vaginal mucus, faeces and placenta.
Onset of immunity: not established.
Duration of immunity: not established. Protection has been demonstrated by challenge 8 weeks post-
primary vaccination (see section 4.9)
5.
None
18
6.
Cattle
It is very common (in 8 out of 10 animals) to see a palpable reaction of maximum diameter of 9 to 10 cm
at the injection site, which may last for 17 days. The reaction gradually reduces and disappears without
need for treatment.
Goats:
It is very common (in 4 out of 12 animals) to see a palpable reaction of 3 to 4 cm diameter at the injection
site which may last for 6 days. The reaction reduces and disappears without need for treatment.
It is very common (more than 1 in 10 animals) to observe a slight increase of rectal temperature for 4 days
post-vaccination without other general signs.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle and goats
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Subcutaneous use
Administer the vaccine as follows:
Cattle: 4ml in the neck region
Goats: 2 ml in the neck region
Although efficacy claim is based on data from challenge test carried out on goats vaccinated twice 6 and 3
weeks before start of pregnancy, there are indications from a large field trial that it is useful to vaccinate
young animals. This information along with data obtained in sheep and cattle, allow recommending the
following vaccination program:
Cattle from 3 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3-weeks. Under normal conditions the
timing of vaccination should be planned so that the primary course is completed by 3 weeks before
artificial insemination or mating.
Re-vaccination:
Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Goat from 3 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3-weeks. Under normal conditions the
timing of vaccination should be planned so that the primary course is completed by 3 weeks before
artificial insemination or mating.
Duration of immunity has not been established. Protection has been demonstrated by challenge 8 weeks
post-primary vaccination.
19
9.
ADVICE ON CORRECT ADMINISTRATION
Shake well before use.
Respect normal aseptic conditions.
10. WITHDRAWAL PERIOD
Meat, milk and offal: Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (2 C - 8 C).
Do not freeze.
Protect from light.
Do not use after the expiry date stated on the label.
Once opened, use within 10 hours.
12. SPECIAL WARNING(S)
It is advisable to vaccinate all the animals in the herd at the same time.
Vaccination of animals already infected at the time of vaccination will have no adverse effect.
The vaccine is safe to use during lactation.
No efficacy data are available concerning the use of the vaccine in male animals. However, in safety
laboratory trials, the use of the vaccine in males proved to be safe. In the case that it is decided to
vaccinate the whole herd, it is advisable to vaccinate the male animals at the same time.
There are no benefits of the vaccine (as described in the indications for cattle), when used in infected
and/or pregnant cows.
The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
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.
Cattle
With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site,
lasting for 16 days. The reaction gradually reduced and disappeared without need for treatment.
Goats
With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site,
lasting for 4 days. The reaction reduced and disappeared without need for treatment.
Do not mix with other veterinary medicinal product.
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet
or the label, to the physician.
20
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help
to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
30/09/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
The vaccine contains phase I
Coxiella burnetii
as active ingredient inducing active immunity against Q
fever in cattle and goats.
Pack sizes: 40 ml and 100 ml in LDPE bottle.
Not all pack sizes may be marketed.
The import, sale, supply and/or use of COXEVAC is or may be prohibited in certain Member States on the
whole or part of their territory pursuant to national animal health policy. Any person intending to import,
sell, supply and/or use COXEVAC must consult the relevant Member State’s competent authority on the
current vaccination policies prior to the import, sale, supply and/or use.
21
Source: European Medicines Agency
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