Filavac VHD K C+V (Canada)

Company: Ceva Animal Health

Rabbit Haemorrhagic Disease Virus, classic and variant, killed virus Vaccine

RHDV1/RHDV2 inactivated

1. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

FILAVIE - 20, LA CORBIÈRE - ROUSSAY - 49450 SÈVREMOINE - FRANCE

2. NAME OF THE VETERINARY VACCINE

RHDV1/RHDV2 inactivated, FILAVAC VHD K C+V suspension for injection for rabbits.

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of vaccine (0.5 ml) contains:

Active substances:

Adjuvant:

(*) Protective dose in at least 90% of the vaccinated animals.

Suspension for injection.

Reddish homogeneous suspension.

4. INDICATIONS

For active immunisation of rabbits from 10 weeks of age, to reduce mortality due to rabbit haemorrhagic disease caused by classical (RHDV1) and type 2 (RHDV2) virus strains.

Onset of immunity: 1 week.

Duration of immunity: 1 year.

5. CONTRAINDICATIONS

None.

6. ADVERSE REACTIONS

A temporary increase in body temperature of up to 1.6°C has been observed very commonly one day after vaccination in clinical studies.

A limited local reaction (subcutaneous nodule, the size of which was up to 10 mm in diameter in the double dose study) which may be palpable for at least 52 days and which disappears without treatment has been observed very commonly in clinical studies.

Serious hypersensitivity reactions which may be fatal have been reported very rarely from post

marketing pharmacovigilance reporting.

Lethargy and/or inappetence have been reported very rarely in the first 48 hours after injection, from post marketing pharmacovigilance reporting.

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 side 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

Rabbits.

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

Subcutaneous use.

One dose (0.5 ml) per subcutaneous injection per animal.

Primary vaccination: from the 10th week of age.

Revaccination: annually.

9. ADVICE ON CORRECT ADMINISTRATION

Apply usual aseptic conditions.

Shake gently before and occasionally during administration to maintain a homogeneous suspension.

10. WITHDRAWAL PERIOD(S)

21 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2°C - 8°C).

Do not freeze.

Protect from light.

Do not use this veterinary vaccine after the expiry date which is stated on the label.

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

Shelf life after first opening the container: 2 hours.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

No information is available on the use of the vaccine in seropositive animals, including animals with maternally derived antibodies. Thus, in situations where a high level of antibodies is expected, the vaccination scheme must be adjusted accordingly.

The efficacy of the vaccine in animals younger than 10 weeks of age has not been demonstrated.

Special precautions for use in animals:

Not applicable.

Special precautions to be taken by the person administering the veterinary vaccine to animals:

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product contains aluminium hydroxide. An accidental self-injection by the person administering the vaccine may result in a local inflammatory reaction, with more or less severe pain at the injection site (in particular if injected into a finger).

Accidental injection to humans may result in bacterial infection.

As soon as possible after the accidental (self-) injection, you must:

- Clean and disinfect the injection site.

- Put ice on the zone of injection.

- Seek prompt medical advice and take the package (vial, label and leaflet) insert with you.

Pregnancy:

During a field trial, no case of abortion was noted after administration of the vaccine to pregnant animals.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Fertility:

The influence of the vaccination on the fertility of rabbits has not been investigated.

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 reactions other than those referenced in section 6 have been observed after administration of a double dose of vaccine.

Incompatibilities:

Do not mix with any other 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.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

July 2022

15. OTHER INFORMATION

50 doses: 1 vial with 25 ml vaccine.

10 vials with 25 ml vaccine.

200 doses: 1 vial with 100 ml vaccine.

10 vials with 100 ml vaccine.

Secondary packaging: cardboard box.

Single-dose: 1 vial with 0.5 ml vaccine.

5 vials with 0.5 ml vaccine.

10 vials with 0.5 ml vaccine.

Secondary packaging: plastic blister.

Not all pack sizes may be marketed.

For any information about this veterinary vaccine, please contact the local representative of the marketing authorisation holder.

Marketing authorisation holder:

FILAVIE, 20, LA CORBIÈRE - ROUSSAY, 49450 SÈVREMOINE, FRANCE

Tel.: +33 2 41 75 46 16

E-mail: contact.filavie@filavie.com

Distributed by:

CEVA ANIMAL HEALTH Inc., 150 Research Lane, Suite 225, Guelph ON N1G 4T2

Toll free: 1-800-510-8864

FOR VETERINARY USE ONLY

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CPN: 1221162.0