Eurican Herpes 205 - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 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

*expressed in ^g of gB glycoproteins

Solvent:

Adjuvant:

Light paraffin oil

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 PARTICULARS4.1 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.

• 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:

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.

• 4.6 Adverse reactions (frequency and seriousness)

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).

• 4.7 Use during pregnancy, lactation or lay

This vaccine is specifically indicated during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

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 Amounts to be administered and administration route

Following reconstitution of the powder with the solvent, inject one dose (1 ml) of the vaccine via the subcutaneous route, according to the following schedule:

Either during heat or 7 to 10 days after the presumed date of mating. 1 to 2 weeks before the expected date of whelping.

During each pregnancy, according to the same schedule.

The reconstituted content shall be a milky emulsion.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No undesirable effects other than those mentioned in the “Adverse reactions” section 4.6 have been observed after the administration of several doses.

• 4.11 Withdrawal period(s)

Not applicable.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for dogs, canine herpesvirus

ATCvet code: QI07AA06

Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Light paraffin oil

Polyoxyethylene fatty acids

Ether of fatty alcohols and of polyols

Sucrose

Sorbitol

Dextran 40

Casein hydrolysate

Collagen hydrolysate

Salts

Triethanolamine

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after reconstitution according to directions: use immediately.

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 for 1-dose and glass bottle containing 1ml of solvent.

The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap

Box of 2 × 1 bottle, 2 × 10 bottles and 2 × 50 bottles.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/01/029/001– 003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26/03/2001

Date of last renewal: 18/04/2006