Eurican Herpes 205
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-08-2020
Charakterystyka produktu
(SPC)
20-08-2020
Sprawozdanie z oceny publicznego
(PAR)
16-02-2021
Składnik aktywny:
Canine herpesvirus (F205 strain) antigens
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QI07AA
INN (International Nazwa):
Canine herpes vaccine (inactivated subunit)
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Immunologicals for canidae
Wskazania:
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.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2001-03-26
Ulotka dla pacjenta
14
B. PACKAGE LEAFLET
15
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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY 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:
Lyophilisate :
ACTIVE SUBSTANCE:
Canine herpesvirus (F205 strain) antigens
0.3 to 1.75 µg*
*expressed in µg of gB glycoproteins
Solvent:
ADJUVANT
: Light paraffin oil
224.8 to 244.1 mg
Lyophilisate: white pellet.
Solvent: homogeneous white emulsion
4.
INDICATIONS
Active immunisation of pregnant bitches to prevent mortality, clinical
signs and lesions in puppies
resulting from canine herpes virus infections acquired in the first
few days of life through passive
immunity.
5.
CONTRAINDICATIONS
None.
16
6.
ADVERSE REACTIONS
The vaccine may commonly cause transient oedema at the site of
injection. These reactions usually
regress within one week.
Hypersensitivity reactions may rarely occur. Appropriate symptomatic
treatment should be
administered.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any serious effects or other effects, even those not
already listed in this package leaflet,
or you think that
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican Herpes 205 powder and solvent for emulsion for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml dose:
Lyophilisate :
ACTIVE SUBSTANCE:
Canine herpesvirus (F205 strain) antigens
0.3 to 1.75 µg*
*expressed in µg of gB glycoproteins
Solvent
:
ADJUVANT:
Light paraffin oil
224.8 to 244.1 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for emulsion for injection
Lyophilisate : white pellet.
Solvent: homogeneous white emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pregnant bitches to prevent mortality, clinical
signs and lesions in puppies
resulting from canine herpes virus infections acquired in the first
few days of life through passive
immunity.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Abortion and premature parturition can occur as a result of CHV
infection in bitches, the protection of
the bitch against infection has not been studied for this vaccine. In
order for immunity to be conferred
to the puppies, sufficient intake of colostrum is required.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
To the user:
This veterinary medicinal 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.
To the physician:
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