BIOSUIS M. hyo – a new vaccine for pigs is already available

As of February 1, 2012, Bioveta, a.s. commenced the sale of new preparation BIOSUIS M.hyo - inactivated vaccine for active immunization of porkers and mitigation of consequences of the infections with Mycoplasma hyopneumoniae – bacteria causing porcine enzootic pneumonia

Dosage:

• 1 dose after the pig´s age of 10 days [BIOSUIS M.hyo]
• in the case of strong infection pressure it is possible to administer 2 doses, the first dose after the pig´s age of 7 days and the second one in the time interval of 3 weeks
• vaccine dose 2 ml

• inactivated vaccine with oil adjuvant potentializing immunogenic properties
• reduces pulmonary lesions resulting from the infection with Mycoplasma hyopneumoniae
• active immunity is fully achieved on 21st day after the vaccination
• the vaccine offers protection for whole fattening period
• zero withdrawal period
• package 100 ml, 250 ml

QUALITATIVE AND QUANTITATIVE COMPOSITION

One vaccine dose (2.0 ml of vaccine) contains:

Active substances:

Mycoplasma hyopneumoniae, inactivatum   RP ≥ 1*

*RP = Relative potency (ELISA) by comparison with reference serum obtained from mice after vaccination with vaccine batch conforming to challenge test on target animal.

Adjuvant:

• Montanide ISA 35 VG    0.2 ml

Excipients:

• Formaldehyde 35%   max. 2 mg
• Thiomersal     0.17 – 0.23 mg

PHARMACEUTICAL FORM

Emulsion for injection.

Milky liquid of yellowish-white to light pink colour without sediment or with small amount of sediment dispersing after shaking.

TARGET SPECIES:

Pigs (fattening pigs)                       

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES

The vaccine is intended for active immunization of fattening pigs to mitigate the effects of infection withMycoplasma hyopneumoniae - a causative agent of enzootic pneumonia in pigs.

Active immunity starts in vaccinated piglets 21 days after vaccination, or revaccination if 2 doses are applied. Vaccine ensures duration of immunity during fattening.

CONTRAINDICATIONS

Do not use in case of any acute or febrile illness.

SPECIAL WARNINGS FOR EACH TARGET SPECIES

None.

SPECIAL PRECAITIONS FOR USE

Special precautions for use in animals

Only clinically healthy animals can be vaccinated.

During the vaccination is necessary to avoid stressing of animals

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

This product contains oil. Accidental injection/self injection may result in severe pain and swelling, paricularly if injected into a join 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 promt 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.

ADVERSE REACTIONS

Local reactions up to 3 cm in diameter can occur after application, which disappear spontaneously within 3 days. Some animals may manifest a transient increase in body temperature max. 1°C.

Occasionally hypersensitive reaction may occur. In this case, you must promptly initiate appropriate treatment.

USE 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.

AMOUNTS TO BE ADMINISTERSD AND ADMINISTRATION ROUTE

Vaccination: A 2-ml dose of the vaccine should be administered according to the following schedule:

1 dose after Day 10 of age.

In the farms with high infection pressure by Mycoplasma hyopneumoniae 2 doses at an interval of 3 weeks can be used from 7 days of age.

Selection of the vaccination schedule depends on knowing the disease incidence on a particular farm.

Method of administration: Intramuscularly, preferably into the paraauricular region.

Before use heat the contents of the vial to room temperature 15 – 20 °C and well shake.

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

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

SPECIAL PRACAUTIONS FOR STORAGE

Store in a refrigerator (2 °C - 8 °C).

Protect from light.

Protect from frost.

PACKAGE SIZE:

1 x 50 doses (100 ml), 1 x 125 doses (250 ml)