Ivory-coloured suspension for injection

Target Species: Sheep (ewe)

For active immunization of animals to reduce clinical signs (abortion, stillbirth, early mortality and hyperthermia) caused by Chlamydia abortus, abortions caused by Salmonella Abortusovis and to reduce shedding of both pathogens from infected animals. Vaccination covers the whole gestation period when administered according to the approved schedule.

For use in ewes from 5 months of age onwards.

Dose: 2ml by subcutaneous injection, behind the shoulder in the rib area (lateral thoracic region).

Basic Vaccination: Animals should receive 2 vaccine doses with an interval of 3 weeks. The first dose should be administered at least 5 weeks before artificial insemination or mating. Administer the second dose 3 weeks after the first dose.

Revaccination: A single booster dose (2ml) should be administered 2 weeks before each artificial insemination or mating, but no later than 1 year after initial basic vaccination.

Shake well before use and occasionally during administration. Allow the vaccine to reach room temperature (15-25 °C) before administration. Administer under aseptic conditions. Only sterile syringes and needles should be used.

Active substances: Inactivated Chlamydia abortus strain A22, RP*≥1. Inactivated Salmonella enterica subsp. enterica serovar Abortusovis strain Sao, RP*≥1.

*Relative Potency determined by ELISA using a reference vaccine determined to be efficacious.

Adjuvants: Aluminium hydroxide 5.29mg, DEAE Dextran 20mg.

Contra-indications: Do not use in cases of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.

Special warnings for the target species: Vaccinate healthy animals only. In farms with recurring reproductive disorders caused by Chlamydia abortus and/or Salmonella Abortusovis, it would be advisable to maintain a high level of immunity within the flock.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions: A palpable local reaction at the injection site, which may appear approximately 1 week post-vaccination, occurred very commonly in studies. In most cases, the reaction is slight or moderate and subsides within 2 weeks without treatment. In some isolated cases, these reactions can reach up to 6 cm but rapidly decrease in diameter within 2 days without need for treatment. An increase in temperature of up to 1.0 °C occurred very commonly 1 day after vaccination in studies. This slight increase subsided spontaneously within 24 hours.

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).

Use during pregnancy, lactation or lay: Safety of the vaccine during pregnancy and lactation has been established, as well as efficacy during the second third of gestation. The use is not recommended during the last month of gestation.

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.

Overdose (symptoms, emergency procedures, antidotes), if necessary: No information is available

Withdrawal period: Zero days.

Pharmacotherapeutic group: Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia). ATC vet code: Q104AB

Excipients: Aluminium hydroxide, DEAE Dextran, Simethicone emulsion, Disodium phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, sodium chloride & water for injections.

Major Incompatibilities: Do not mix with any other veterinary medicinal product.

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 precautions for storage: Store and transport refrigerated (2-8°C). Do not freeze. Protect from light.

Nature and composition of immediate packaging: Polyethylene (PET) vials of 10, 50, 100 and 250ml closed with rubber stopper and aluminium cap.

Cardboard box with 1 PET vial of 5 doses (10ml). Cardboard box with 1 PET vial of 25 doses (50ml). Cardboard box with 1 PET vial of 50 doses (100ml). Cardboard box with 1 PET vial of 125 doses (250ml). Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Laboratorios Hipra, S.A., Avda. la Selva, 135, 17170 Amer (Girona), Spain.

Nil

Vm 17533/4019