Fatrovax RHD - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

FATROVAX RHD suspension for injection for rabbits

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release :

FATRO S.p.A., Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALY

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

FATROVAX RHD suspension for injection for rabbits

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

Each dose (0.5 ml) contains:

Active substances:

Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a* >1 RP

Rabbit haemorrhagic disease virus 2 (RHDV2) VPlab* >1 RP

• * recombinant capsid protein

• * * Relative potency: ELISA test by comparison with a reference serum in vaccinated mice

Adjuvant:

Aluminium hydroxide (as Al3+)

Preservative:

Thiomersal

Whitish aqueous suspension with soft white sedimentation easily resuspendable.

• 4. INDICATION(S)

For active immunisation of rabbits from the age of 28 days to reduce mortality, infection, clinical signs and organ lesions of rabbit haemorrhagic disease caused by RHDV1 and RHDV2.

Onset of immunity: 1 week (7 days) after vaccination.

Duration of immunity: 1 year.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

A very small transient nodule at the site of injection may commonly be visible or palpable in the first week post vaccination in laboratory trials. In the repeated dose laboratory trials, upon necropsy small nodules in the subcutis at the injection site were commonly observed.

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, including pet (dwarf) rabbits

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

0.5 ml by subcutaneous route.

Vaccination programme:

Administer the first dose at 28 days of age; revaccinate every 12 months.

Vaccination using the single-dose presentation (0.5 ml)

The pre-filled glass syringes needs to be attached to the needle included in the packaging.

Administer one dose by subcutaneous injection.

Vaccination using multi-dose presentations (50 doses (25 ml) or 200 doses (100 ml))

The elastomer stoppers of the polypropylene bottles need to be punctured with a needle (attached to a syringe) to extract the appropriate volume for vaccination (0.5 ml per animal). Administer one dose by subcutaneous injection.

• 9. ADVICE ON CORRECT ADMINISTRATION

Before use allow the product to reach room temperature.

Shake well before use to resuspend the sediment.

• 10. WITHDRAWAL PERIOD(S)

Zero 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 medicinal product after the expiry date which is stated on the carton and on the label after EXP. The expiry date refers to the last day of that month.

Shelf life after first opening the immediate packaging: 10 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

The possible interference of MDAs cannot be excluded at the recommended age for vaccination.

Special precautions for use in animals:

Pregnant does should be handled with special care to avoid stress and risk of abortion.

The effect on reproductive performance in male rabbits was not evaluated.

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

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

Use during pregnancy, lactation or lay:

Can be used 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):

In dwarf rabbits, small transient nodules at the injection site were commonly noted after administration of a 2X dose.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 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 or pharmacist 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