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Eurican Herpes 205

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Summary for the public


What is Eurican Herpes 205?

Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection. Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 μg.


What is Eurican Herpes 205 used for?

Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.

Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses. The first injection is given either when the bitch is on heat or 7 –10 days after the date of mating. The second injection is given 1 to 2 weeks before the expected date of whelping. The bitch should be revaccinated in the same way during each pregnancy.


How does Eurican Herpes 205 work?

Eurican Herpes 205 contains small amounts of canine herpes virus antigens. When injected, this small exposure helps the dog’s immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies. When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection. Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.


How has the effectiveness of Eurican Herpes 205 been studied?

Eurican Herpes 205 has been studied in three laboratory studies and two field trials. In one field trial the serological response (antibody production) was measured. In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel. The first laboratory study tested the dose needed to provide protection. The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus. Here Eurican Herpes 205 was compared with no vaccination (controls). The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.


What benefit has Eurican Herpes 205 shown during the studies?

Eurican Herpes 205 showed good protection from canine herpes virus. In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived.


What are the side effects of Eurican Herpes 205?

The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals. This side effect usually disappears within one week. Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Eurican Herpes 205 contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.


Why has Eurican Herpes 205 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus. They recommended that Eurican Herpes 205 should be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.


Other information about Eurican Herpes 205

The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001. Information on the prescription status of this product may be found on the labelling.

Authorisation details
Name: Eurican Herpes 205
EMEA Product number: EMEA/V/C/000059
Active substance: Canine herpesvirus (F205 strain) antigens
INN or common name: Live adjuvanted vaccine against canine herpes virus
Species: Dogs
ATCvet Code: QI07AA
Marketing Authorisation Holder: Merial
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 26/03/2001
Contact address:
Merial
29, avenue Tony Garnier
69007 Lyon
FRANCE



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 powder and solvent for emulsion for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
* expressed in µg of gB glycoproteins
Adjuvant(s)
Light paraffin oil ........................................................................................................224.8 to 244.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for emulsion for injection
4.
CLINICAL PARTICULARS
4.1 Target species
Dogs (pregnant bitches)
4.2 Indications for use, specifying the target species
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
from canine herpes virus infections acquired in the first few days of life.
4.3 Contraindications
None.
4.4 Special warnings
None.
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain
and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of
the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small
amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
2/19
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with
this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even
the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision
and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
4.6 Adverse reactions (frequency and seriousness)
The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of
animals. These reactions usually regress within one week.
Hypersensitivity reactions may occur. These are rare and appropriate symptomatic treatment should be
administered.
4.7
Use during pregnancy, lactation or lay
Eurican Herpes 205 is specifically indicated during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the efficacy from the concurrent use of this vaccine with any other
product. It is therefore recommended that no other vaccines should be administered within 14 days
before or after vaccination with the product.
4.9 Amounts to be administered and administration route
Two 1-ml doses of vaccine, administered by subcutaneous route, according to the following schedule:
First injection : Either during heat or 7 –10 days after the presumed date of mating.
Second injection : 1 to 2 weeks before the expected date of whelping.
Revaccination : during each pregnancy, according to the same schedule.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects other than those observed and mentioned in the “Adverse reactions” section
have been observed after the administration of several doses.
4.11 Withdrawalperiod(s)
Not applicable.
5.
IMMUNOLOGICAL PROPERTIES
ATCvet code: QI07AA06
Purified subunit vaccine for the active immunisation of pregnant bitches to induce the passive
protection of puppies against herpesvirus-induced fatal neonatal disease.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Sorbitol
Dextran 40
3/19
Casein hydrolysate
Collagen hydrolysate
Salts
Polyoxyethylene fatty acids
Ether of fatty alcohols and of polyols
Triethanolamine
6.2 Incompatibilities
Do not mix with any other immunological product except the solvent supplied.
6.3 Shelf life
24 months.
Use immediately after reconstitution.
6.4. Special precautions for storage
Store in a refrigerator (2
°
C – 8
°
C). Do not freeze. Protect from light.
6.5 Nature and composition of immediate packaging
Type I glass bottle containing powder of 1-dose and glass bottle containing 1-ml of solvent.
The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap
Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
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
products should be disposed of in accordance with the local requirements.
7.
MARKETING AUTHORISATION HOLDER
MERIAL
29 Avenue Tony Garnier
F-69007 Lyon
FRANCE
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/01/029/001- 003
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26.03.06
4/19
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA) http://www.emea.eu.int/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5/19
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
6/19
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)
Merial, Laboratory of Lyon Gerland
254, Avenue Marcel Mérieux, 69007 Lyon, France
Name and address of the manufacturer(s) responsible for batch release
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
France
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
Not applicable.
7/19
ANNEX III
LABELLING AND PACKAGE LEAFLET
8/19
A. LABELLING
9/19
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{NATURE/TYPE}
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 powder and solvent for emulsion for injection
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
* expressed in µg of gB glycoproteins
Light paraffin oil
3.
PHARMACEUTICAL FORM
Powder and solvent for emulsion for injection.
4.
PACKAGE SIZE
1 dose: powder (1 bottle) + solvent (1 bottle)
50 doses: powder (50 bottles) + solvent (50 bottles)
5.
TARGET SPECIES
Dogs (pregnant bitches)
6.
INDICATION(S)
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
from canine herpes virus infections acquired in the first few days of life.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Not applicable.
10/19
 
9.
SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Use immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29 Avenue Tony Garnier
F-69007 Lyon
France
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles)
EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
17. MANUFACTURER’S BATCH NUMBER
Lot
11/19
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{NATURE/TYPE}
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 powder and solvent for emulsion for injection
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
* expressed in µg of gB glycoproteins
Light paraffin oil
3.
PHARMACEUTICAL FORM
Powder and solvent for emulsion for injection.
4.
PACKAGE SIZE
10 doses: powder (10 bottles) + solvent (10 bottles)
5.
TARGET SPECIES
Dogs (pregnant bitches)
6.
INDICATION(S)
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
from canine herpes virus infections acquired in the first few days of life.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read the package leaflet before use.
12/19
 
10. EXPIRY DATE
EXP {month/year}
Use immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29 Avenue Tony Garnier
F-69007 Lyon
France
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles)
17. MANUFACTURER’S BATCH NUMBER
Lot
13/19
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{NATURE/TYPE}
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 powder for injection
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Read the package leaflet before use
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 dose
4.
ROUTE(S) OF ADMINISTRATION
SC
5.
WITHDRAWAL PERIOD
Withdrawal period: Not applicable.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP {month/year}
Use immediately after reconstitution.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14/19
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{NATURE/TYPE}
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 solvent
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Read the package leaflet before use
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 ml
4.
ROUTE(S) OF ADMINISTRATION
SC
5.
WITHDRAWAL PERIOD
Withdrawal period: Not applicable.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP {month/year}
Use immediately after reconstitution.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15/19
 
B. PACKAGE LEAFLET
16/19
PACKAGE LEAFLET
Eurican Herpes 205 powder and solvent for emulsion for injection
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder :
MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
Manufacturer for the batch release :
MERIAL, Laboratoire Porte des Alpes, Rue de l’Aviation, F-69800 Saint Priest, France
2.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Eurican Herpes 205 powder and solvent for emulsion for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
* expressed in µg of gB glycoproteins
Light paraffin oil
4.
INDICATION(S)
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
from canine herpes virus infections acquired in the first few days of life.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Hypersensitivity reactions may occur. These are rare and appropriate symptomatic treatment should be
administered.
The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of
animals. These reactions usually regress within one week.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Dogs (pregnant bitches)
17/19
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Two 1-ml doses of vaccine, administered by subcutaneous route, according to the following schedule:
First injection : Either during heat or 7 –10 days after the presumed date of mating.
Second injection : 1 to 2 weeks before the expected date of whelping.
Revaccination : during each pregnancy, according to the same schedule.
9.
ADVICE ON CORRECT ADMINISTRATION
None.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
C). Do not freeze. Protect from light.
Use immediately after reconstitution.
Do not use after the expiry date stated on the label.
°
C – 8
°
12. SPECIAL WARNING(S)
Vaccinate only healthy animals.
Do not mix with any other immunological product except the solvent supplied.
Eurican Herpes 205 is specifically indicated during pregnancy.
No information is available on the efficacy from the concurrent use of this vaccine with any
other product. It is therefore recommended that no other vaccines should be administered within
14 days before or after vaccination with the product
No undesirable effects other than those observed and mentioned in the “Adverse reactions”
section have been observed after the administration of several doses.
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain
and swelling, particularly if injected into a joint or finger, and in rare cases could result in the
loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a
very small amount is injected and take the package insert with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental
injection with this product can cause intense swelling, which may, for example, result in
ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required
and may necessitate early incision and irrigation of the injected area, especially where there is
involvement of finger pulp or tendon.
18/19
Keep out of the reach and sight of children
Store in a refrigerator (2
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with the local requirements.
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
(EMEA) http://www.emea.eu.int/
15. OTHER INFORMATION
Purified subunit vaccine for the active immunisation of pregnant bitches to induce the passive
protection of puppies against herpesvirus-induced fatal neonatal disease.
Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Not all pack sizes may be marketed.
To be supplied only on veterinary prescription.
19/19


Source: European Medicines Agency



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