Each 2 ml dose of vaccine contains:

Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS) virus, P120 strain ≥ 2.5 log10 IF* units.

*IF units: ImmunoFluorescence antibody titre obtained after 2 injections in pigs under specific laboratory conditions.

O/w oily excipient (containing hydrogenated polyisobutene as adjuvant) q.s. 1 dose of 2 ml.

For the full list of excipients, see Pharmaceutical particulars.

White homogeneous emulsion for injection.

Pigs (sows and gilts).

Reduction of the reproductive disorders caused by Porcine Reproductive and Respiratory Syndrome virus (European strain) in a contaminated environment: vaccination reduces the number of early farrowings and the number of still-births.

None

In PRRS infected herds, viral infection is heterogeneous and varies over time. In such context, the implementation of a vaccination program is a tool to improve the reproductive parameters and may contribute to the disease control in conjunction with sanitary measures.

Vaccinate healthy animals only.

Apply usual procedures for the handling of animals.

To the user:

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Vaccination may induce a transient oedema (at most 3 cm) lasting generally less than one week and small local reaction (granulomas), without any effect on the health and the reproductive performance of the animal. Larger reactions (up to 7 cm diameter) have been observed occasionally after frequently repeated revaccinations. Vaccination may rarely cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be carried out.

Can be used during pregnancy and lactation.

Data are available which demonstrate that this vaccine can be administered on a same day in a separate site, with inactivated vaccines against parvovirosis, influenza and Aujeszky’s disease as no adverse effect on the serological response has been observed. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other product therefore needs to be made on a case by case basis.

One dose of 2 ml is administered by deep intramuscular route, in the neck muscles behind the ear, according to the following vaccination scheme:

Primary vaccination:

Gilts: 2 injections 3-4 weeks apart, at least 3 weeks before mating.

Sows: 2 injections 3-4 weeks apart (vaccination of all the sows of the herd within a short period is recommended).

Revaccination:

One injection at 60-70 days of each gestation, as of the first gestation following the primary vaccination.

Apply usual aseptic procedures. The use of a multi-dosing syringe is recommended.

After administration of a double dose, no adverse reactions other than those described under Adverse reactions were observed.

Zero days.

Pharmacotherapeutic group: Immunologicals for Suidae/ inactivated viral vaccines/ porcine reproductive and respiratory syndrome (PRRS) virus. ATCvet code: QI09AA05

The vaccine contains inactivated PRRS virus in an oily adjuvant. It is intended to stimulate immunity against PRRS virus. The efficacy was demonstrated under field conditions during field trials. Whereas no effector immunomechanism on protection has been shown, the uptake of the vaccine has been demonstrated by the production of specific anti-PRRS IFA antibodies in vaccinated animals.

Hydrogenated polyisobutene, Polyoxyethylene fatty acids, Ether of fatty alcohols and of polyols, Benzyl alcohol, Triethanolamine, Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride, Calcium chloride, Water for injections.

Do not mix with any other veterinary medicinal product.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf-life after first opening the vial: use immediately after opening.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Nature of primary packaging elements:

Packaging intended for sale:

Box of 1 bottle of 5 doses / 10 ml glass bottle

Box of 10 bottles of 5 doses / 10 ml glass bottle

Box of 1 bottle of 10 doses / 20 ml glass bottle

Box of 10 bottles of 10 doses / 20 ml glass bottle

Box of 1 bottle of 25 doses / 50 ml glass bottle

Box of 10 bottles of 25 doses / 50 ml glass bottle

Box of 1 bottle of 50 doses / 100 ml LDPE bottle

Box of 10 bottles of 50 doses / 100 ml LDPE bottle

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

21 September 2000

October 2022

Nil