Vepured - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

VEPURED suspension for injection for pigs

• 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 :

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

VEPURED suspension for injection for pigs

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

Each dose of 1 ml contains:

Active substance:

Recombinant verotoxin 2e of E. coli.........­.............­.............­.............­.............­... RP* > 1.50

• *RP – relative potency (ELISA)

Adjuvants:

Aluminium hydroxide

DEAE-dextran

Whitish suspension for injection.

• 4. INDICATION(S)

Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli ) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.

Onset of immunity: 21 days after vaccination.

Duration of immunity: 112 days after vaccination.

• 5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.

• 6. ADVERSE REACTIONS

Very common adverse reactions:

• – Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment.

• – Mild depression during the day of vaccination.

• – Temperature rise of maximum 1.1 °C was observed. Temperatures returned to normal within 24 hrs.

Emesis, recumbency, convulsion, lethargy and loss of consciousness occur in very rare cases within a few minutes after vaccination. The animals mostly start to recover within around 15 minutes. In case of severe anaphylactic-type reactions appropriate treatment is recommended.

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 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

Pigs.

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

Intramuscular use.

Administer a single intramuscular injection of 1 ml in the neck muscles.

• 9. ADVICE ON CORRECT ADMINISTRATION

Allow the vaccine to reach room temperature (15–25 °C) before administration.

Shake well before use.

• 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 label after EXP.

Shelf life after first opening the container: 10 hours.

• 12. SPECIAL WARNING(S)

Pregnancy and lactation :

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

The use is not recommended during pregnancy and lactation.

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.

Major incompatibilities:

Do not mix with any other veterinary medicinal product.

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