Eurican Herpes 205 - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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

*expressed in ^g of gB glycoproteins

Solvent:

Adjuvant : Light paraffin oil

Lyophilisate: white pellet.

Solvent: homogeneous white emulsion

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.

• 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 the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

• 9. ADVICE ON CORRECT ADMINISTRATION

Aseptically reconstitute the contents of the powder with the solvent supplied with this vaccine. The reconstituted content shall be a milky emulsion.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

Shelf life after reconstitution according to directions: use immediately.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

• 12. SPECIAL WARNING(S)

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

Special precautions for use in animals:

None.

Special precautions to be taken by the person administrating 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 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.

Pregnancy and lactation:

This vaccine is specifically indicated during pregnancy.

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.

Overdose (symptoms, emergency procedures, antidotes):

No adverse effects other than those-listed in section “Adverse reactions” have been observed after the administration of several doses.

Incompatibili­ties:

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

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED