Suvaxyn PCV - patient leaflet, side effects, dosage

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• 10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency ).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory

MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

• B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

• C. STATEMENT OF THE MRLs

• D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

• A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance(s)

Zoetis Inc.

2000 Rockford Road, Charles City

IA 50616

USA

Name and address of the manufacturer responsible for batch release

Zoetis Manufacturing & Research Spain, S.L.

Ctra. Camprodon s/n „la Riba“

17813 Vall de Bianya

Girona

SPAIN

• B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:

• a) The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.

  b)

  
  

The disease to which the product is intended to confer immunity is largely absent from the territory in question.

• C. STATEMENT OF THE MRLs

The active substance being a principle of biological origin intended to produce active immunity is not

within the scope of Regulation (EC) No 470/2009.

The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicin

• D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Specific pharmacovigilance requirements:

Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.

Read the package leaflet before use.

Single intramuscular injection of one dose (2 ml).

8. WITHDRAWAL PERIOD(S)

Withdrawal period(s): Zero days.

Keep out of the sight and reach of children.

• 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

_

• 16. MARKETING AUTHORISATION NUMBER(S)

EU/2/09/099/001–006

Withdrawal period(s): Zero days.

Lot: {number}

For animal treatment only.

PACKAGE LEAFLET:

SuvaxynPCV 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 :

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release :

Zoetis Manufacturing & Research Spain, S.L.

Ctra. Camprodon s/n „la Riba“

17813 Vall de Bianya

Girona

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suvaxyn PCV suspension for injection for pigs

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

  
  

One dose of 2 ml contains:

Active substance:

Inactivated recombinant Porcine Circovirus type 1 expressing the

Porcine Circovirus type 2 ORF2 protein

Adjuvants:

Sulfolipo-cyclodextrin (SLCD)

Squalane

Excipients:

Thiomersal * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.

A milky white to pink opaque liquid, free from visible particles

• 4. INDICATION(S)

Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus Type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs – including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).

Onset of immunity: from 3 weeks post-vaccination. Duration of immunity: 19 weeks post-vaccination

• 5. CONTRAINDI­CATIONS

None.

A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination. This resolves spontaneously within 48 hours without treatment.

Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days. The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur. In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.

Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting. These clinical signs normally resolve without treatment. Exceptionally, a large proportion of animals may react in some specific herds after vaccination.Severe anaphylactic reactions are uncommon but may be lethal. In case of such 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 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 (piglets) from 3 weeks of age.

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

Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.

• 9. ADVICE ON CORRECT ADMINISTRATION ♦

Shake well before administration and intermittently during the process of vaccination.

The vaccine is to be administered aseptically.

The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s in­structions.

• 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 the bottle.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate only healthy animals.

Do not use in breeding boars.

The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.

Special precautions for use in animals:

Avoid stress in the animals before and after the time of vaccination

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

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

Pregnancy and lactation:

Do not use during pregnancy and lactation.

Interactions 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 except those mentioned in section 6 were observed after the administration of a double dose of vaccine.

Major incompatibilities:

Do not mix with any other veterinary medicinal product.

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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ).

• 15. OTHER INFORMATION