Eryseng Parvo - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

ERYSENG PARVO 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

ERYSENG PARVO suspension for injection for pigs

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

Each dose of 2 ml contains: Inactivated porcine parvovirus, strain NADL-2,...........­.............­.............­.............­... RP* > 1.15,

Inactivated Erysipelothrix rhusiopathiae , strain R32E11,......­........ ELISA > 3.34 log2 IE50%**

• * RP – relative potency (ELISA).

• * * IE50% – Inhibition ELISA 50%.

Aluminium hydroxide....­.............­.............­.............­.............­.............­.............­...5.29 mg (aluminium)

DEAE-Dextran

Ginseng.

Whitish suspension for injection.

• 4. INDICATION(S)

For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.

For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae , serotype 1 and serotype 2.

Onset of immunity:

Porcine parvovirus: from the beginning of the gestation period.

E. rhusiopathiae : three weeks after completion of the basic vaccination scheme.

Duration of immunity:

Porcine parvovirus: vaccination provides foetal protection for the duration of gestation. Revaccination should be performed prior to each gestation, refer to section “Dosage for each species, route(s) and method of administration”.

• E. rhusiopathiae : vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.

• 5. CONTRAINDI­CATIONS

Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.

• 6. ADVERSE REACTIONS

Very common adverse reactions:

• – Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.

Common adverse reactions:

• – A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies.

Very rare adverse reactions:

• – Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic 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 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

Pigs.

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

Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:

Basic vaccination:

Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3–4 weeks. The second injection should be administered 3–4 weeks before mating.

Revaccination :

A single injection should be given 2–3 weeks prior to each subsequent mating (approximately every 6 months).

For simultaneous use with UNISTRAIN PRRS in sows for reproduction from 6 months of age, the mixed administration of ERYSENG PARVO and UNISTRAIN PRRS should only be used when vaccinating animals prior to mating.

The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO. A single dose (2 ml) of the mixed vaccines should be injected within a period of 2 hours via intramuscular use.

• 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: use immediately.

Shelf life after mixing with UNISTRAIN PRRS: 2 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

Special precautions for use in animals :

None.

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

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

Pregnancy and lactation :

Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site. The product information of UNISTRAIN PRRS should be consulted before administration of the mixed products.

The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.

For mixed use the onset and duration of immunity of the parvovirus component and the onset of immunity of the Erysipelas component have been demonstrated to be equivalent to those determined for ERYSENG PARVO when used alone. However, the duration of immunity of the Erysipelas component following mixed use has not been investigated.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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 already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.

Major incompatibilities :

Do not mix with any other veterinary medicinal product except with UNISTRAIN PRRS.

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