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Date: Sunday, April 21, 2024 12:31

Release 8.81
Eurican Herpes 205 powder and solvent for emulsion for injection
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Eurican Herpes 205 Powder and Solvent for Emulsion for Injection
Product index: Eurican Herpes 205
Incorporating:
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: Light paraffin oil 224.8 to 244.1 mg
For the full list of excipients, see Pharmaceutical precautions.
Pharmaceutical form
Powder and solvent for emulsion for injection. Lyophilisate: white pellet. Solvent: homogeneous white emulsion
Clinical particulars
Target species
Dogs (pregnant bitches).
Indications for use
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 through passive immunity.
Contra-indications
None.
Special warnings
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.
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the 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: This veterinary medicinal 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.
Adverse reactions
The vaccine may commonly cause transient oedema at the site of injection. These reactions usually regress within one week.
Hypersensitivity reactions may occur. These are rare and 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 displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
This vaccine is specifically indicated during pregnancy.
Interactions
No information is available on the efficacy from the concurrent use of this vaccine 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.
Amounts to be administered and administration route
Following reconstitution of the powder with the solvent, inject one dose (1ml) of the vaccine via the 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.
The reconstituted content shall be a milky emulsion.
Overdose
No undesirable effects other than those observed and mentioned in the 'Adverse reactions' section have been observed after the administration of several doses.
Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
ATCvet code: QI07AA06
Pharmaceutical particulars
Excipients
Sucrose, Sorbitol, Dextran 40, Casein hydrolysate, Collagen hydrolysate, Salts, Polyoxyethylene fatty acids, Ether of fatty alcohols and of polyols, Triethanolamine.
Incompatibilities
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Shelf life after reconstitution: Use immediately
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.
Immediate packaging
Type I glass bottle containing powder for 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.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
UK(GB): Vm 04491/5008
UK(NI): EU/2/01/029/003
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Eurican Herpes 205 single dose vial
GTIN:3661103006220