ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Ingelvac CircoFLEX suspension for injection for pigs
2.
Each dose of 1 ml of inactivated vaccine contains:
Active substance:
Porcine circovirus type 2 ORF2 protein:
minimum RP* 1.0
maximum RP* 3.75
* Relative Potency (ELISA test) by comparison with a reference vaccine
Adjuvant:
Carbomer
1 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection.
4.
Pigs (from 2 weeks of age)
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to
reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated
with PCV2 related disease (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and
lymphoid tissues, and duration of viraemia.
Onset of protection occurs by 2 weeks post vaccination and lasts for at least 17 weeks.
None.
None.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None.
2
A mild and transient hyperthermia very commonly occurs on the day of vaccination.
On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.
Do not use during pregnancy and lactation.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with
Boehringer Ingelheim’s Ingelvac MycoFLEX and administered at one injection site.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product except the product mentioned above. 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.
Shake well before use.
Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Avoid introduction of contamination during use.
Vaccines devices should be used in accordance with the device instructions provided by the
manufacturer.
Avoid multiple broaching.
When mixed with Ingelvac MycoFLEX:
Vaccinate only pigs as from 3 weeks of age.
When mixed with Ingelvac MycoFLEX the following equipment should be used:
Use the same pack sizes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Use the appropriate pack sizes for the number of pigs to be vaccinated.
Use
two separate pre-sterilized transfer needles.
Use a pre-sterilized transfer container (HDPE or EVA plastic container, Type I or Type II glass
containers closed with natural latex, polybutene-1 rubber or siliconised chlorobutyl stoppers) of
at least the double volume of an individual bottle size.
Pre-sterilized transfer containers and transfer needles (CE certified) are commonly available via
medical equipment suppliers.
To ensure correct mixing follow the steps as described below:
1.
Connect one end of the first transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
- Aseptically transfer the Ingelvac CircoFLEX vaccine to the transfer container by inverting
the vaccine bottle. If needed, gently press the vaccine bottle to facilitate the transfer.
- After transfer of the full content, disconnect and discard the transfer needle and the empty
vaccine bottle from the transfer container.
3.
Connect one end of the second transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
4.
To transfer the Ingelvac MycoFLEX vaccine into the transfer container already filled with
Ingelvac CircoFLEX, repeat step 2.
3
2.
- Connect the opposite end of the transfer needle to the transfer container.
5.
To ensure appropriate mixing of the vaccines, shake the transfer container well until the mixture
is of uniform orange to reddish colour. During vaccination the uniformity of the coloured
mixture should be monitored and maintained by continuous agitation.
6.
Administer one single injection dose (
2 ml
) of the mixture intramuscularly per pig, irrespective
of body weight. For administration, vaccine devices should be used in accordance with the
device instructions provided by the manufacturer.
Use the entire content of the transfer container immediately after mixing. Any unused mixture or
waste material should be disposed according to the instructions given in section 6.6.
Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those
described under section 4.6. have been observed.
4.11 Withdrawalperiod
Zero days.
5.
Pharmacotherapeutic group: Inactivated Porcine circovirus vaccine
ATC vet code:
QI09AA07
This vaccine is designed to stimulate the development of an active immune response to Porcine
circovirus type 2.
6.
6.1 List of excipients
Sodium chloride
Water for injection
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac
MycoFLEX.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 15 months.
Use immediately after opening.
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
High density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml with a chlorobutyl stopper and
lacquered aluminium seal.
4
Each bottle is packed individually in a cardboard box.
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.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8.
EU/2/07/079/001 10 ml
EU/2/07/079/002 50 ml
EU/2/07/079/003 100 ml
EU/2/07/079/004 250 ml
9.
13.02.2008
07.07.2010
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
The import, sale supply and/or use of Ingelvac CircoFLEX 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 Ingelvac CircoFLEX must consult the relevant Member
State's competent authority on the current vaccination policies prior to the import, sale, supply and/or
use.
Ingelvac MycoFLEX may be not authorized in certain Member States.
5
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
6
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Boehringer Ingelheim Vetmedica Inc.
2621 North Belt Highway, St. Joseph, Missouri, 64506
U.S.A.
Name and address of the manufacturer(s) responsible for batch release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
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 constituent of Ingelvac CircoFLEX suspension for injection for pigs are included in
table 1 of the annex to Commission Regulation (EU) No 37/2010 as follows:
Pharmacologically
active substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provision
s
Therapeutic
classification
Sodium chloride
Not
applicable.
All food-
producing
species.
No MRL
required.
Not
applicable.
No entry. No entry.
In addition to the above constituents the product contains the following excipient: carbomer and water
for injection. These excipients
are considered as not falling within the scope of Regulation (EC) No
470/2009.
7
ANNEX III
LABELLING AND PACKAGE LEAFLET
8
A.
LABELLING
9
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{10 ml; 50 ml, 100 ml, 250 ml cardboard box}
1.
Ingelvac CircoFLEX suspension for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of inactivated vaccine contains:
Porcine circovirus type 2 ORF2 protein
Carbomer
3.
Suspension for injection
4.
PACKAGE SIZE
10 ml (10 doses)
50 ml (50 doses)
100 ml (100 doses)
250 ml (250 doses)
5.
Pigs (from 2 weeks of age)
6.
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2).
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Single intramuscular injection of one dose (1 ml)
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
10
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Use immediately after opening.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
Protect from light.
12. SPECIFIC 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.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
EU/2/07/079/001 10 ml
EU/2/07/079/002 50 ml
EU/2/07/079/003 100 ml
EU/2/07/079/004 250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
11
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
{100 ml, 250 ml bottle}
1.
Ingelvac CircoFLEX suspension for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of inactivated vaccine contains:
Porcine circovirus type 2 ORF2 protein
Carbomer
3.
Suspension for injection
4.
PACKAGE SIZE
100 ml (100 doses)
250 ml (250 doses)
5.
Pigs (from 2 weeks of age)
6.
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2).
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Single intramuscular injection of one dose (1 ml).
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
12
10. EXPIRY DATE
EXP {month/year}
Use immediately after opening.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
Protect from light.
12. SPECIFIC 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.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Read the package leaflet before use.
Boehringer Ingelheim Vetmedica GmbH
Germany
EU/2/07/079/001 10 ml
EU/2/07/079/002 50 ml
EU/2/07/079/003 100 ml
EU/2/07/079/004 250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{10 ml, 50 ml bottle}
1.
Ingelvac CircoFLEX suspension for injection for pigs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Each dose of inactivated vaccine contains:
Porcine circovirus type 2 ORF2 protein
Carbomer
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml (10 doses)
50 ml (50 doses)
4.
ROUTE(S) OF ADMINISTRATION
IM
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Use immediately after opening.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET FOR:
Ingelvac CircoFLEX suspension for injection for pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
2.
Ingelvac CircoFLEX suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 1 ml of inactivated vaccine contains:
Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0, maximum RP* 3.75
* Relative Potency (ELISA test) by comparison with a reference vaccine.
Adjuvant: Carbomer
4. INDICATION(S)
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to
reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated
with PCV2 related diseases (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and
lymphoid tissues, and duration of viraemia.
Onset of immunity:
by 2 weeks post vaccination
Duration of immunity:
at least 17 weeks.
5. CONTRAINDICATIONS
None.
6.
A mild and transient hyperthermia very commonly occurs on the day of vaccination.
On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Pigs (from 2 weeks of age)
16
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
9.
ADVICE ON CORRECT ADMINISTRATION
Shake well before use.
Avoid introduction of contamination during use.
Avoid multiple vial broaching.
Vaccination devices should be used in accordance with the device instructions provided by the
manufacturer.
When mixed with Ingelvac MycoFLEX:
Vaccinate only pigs as from 3 weeks of age.
When mixed with Ingelvac MycoFLEX the following equipment should be used:
Use the same pack sizes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Use the appropriate pack sizes for the number of pigs to be vaccinated.
Use
two separate pre-sterilized transfer needles.
Use a pre-sterilized transfer container (HDPE or EVA plastic container, Type I or Type II glass
containers closed with natural latex, polybutene-1 rubber or siliconised chlorobutyl stoppers) of
at least the double volume of an individual bottle size.
Pre-sterilized transfer containers and transfer needles (CE certified) are commonly available via
medical equipment suppliers.
To ensure correct mixing follow the steps as described below:
1.
Connect one end of the first transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
2.
- Connect the opposite end of the transfer needle to the transfer container.
- Aseptically transfer the Ingelvac CircoFLEX vaccine to the transfer container by inverting
the vaccine bottle. If needed, gently press the vaccine bottle to facilitate the transfer.
- After transfer of the full content, disconnect and discard the transfer needle and the empty
vaccine bottle from the transfer container.
3.
Connect one end of the second transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
4.
To transfer the Ingelvac MycoFLEX vaccine into the transfer container already filled with
Ingelvac CircoFLEX, repeat step 2.
5.
To ensure appropriate mixing of the vaccines, shake the transfer container well until the mixture
is of uniform orange to reddish colour. During vaccination the uniformity of the coloured
mixture should be monitored and maintained by continuous agitation.
6.
Administer one single injection dose (
2 ml
) of the mixture intramuscularly per pig, irrespective
of body weight. For administration, vaccine devices should be used in accordance with the
device instructions provided by the manufacturer.
Use the entire content of the transfer container immediately after mixing. Any unused mixture or
waste material should be disposed according with local requirements.
17
For any further information please contact the local representative of the marketing authorisation
holder.
10. WITHDRAWAL PERIOD
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 (EXP) which is stated on the carton and the bottle.
Use immediately after opening.
12. SPECIAL WARNING(S)
Precautions for use in animals
Only healthy animals should be vaccinated.
Use during pregnancy and lactation
Do not use during pregnancy and lactation.
Interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with
Boehringer Ingelheim’s Ingelvac MycoFLEX and administered at one injection site.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product except the product mentioned above. 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.
Incompatibilities
Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac
MycoFLEX.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste material should be disposed of in accordance with
local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
07.07.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
18
15. OTHER INFORMATION
This vaccine is designed to stimulate the development of an active immune response to Porcine
circovirus type 2.
Bottle of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses), or 250 ml (250 doses) packed
individually in a cardboard box.
Not all pack sizes may be marketed.
Ingelvac MycoFLEX may be not authorized in certain Member States.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
19
Source: European Medicines Agency
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