MHYOSPHERE PCV ID (Canada)

Company: Hipra

Emulsion for injection for pigs

Porcine circovirus vaccine, type 2a, Killed Mycoplasma hyopneumoniae Vector

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Each dose of 0.2 ml contains:

Active substance: Inactivated recombinant Mycoplasma hyopneumoniae^cpPC2 strain Nexhyon:

- Mycoplasma hyopneumoniae RP* ≥ 1.3

- Porcine circovirus type 2 (PCV2) capsid protein RP* ≥ 1.3

* Relative Potency determined by ELISA.

Adjuvant: Light mineral oil.

White homogeneous emulsion after shaking.

INDICATION(S): For the active immunisation of pigs: To reduce lung lesions associated with porcine enzootic pneumonia caused by Mycoplasma hyopneumoniae. Also, to reduce the incidence of these lesions (as observed in field studies). To reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by Porcine circovirus type 2 (PCV2). In addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of PCV2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination. Efficacy against PCV2 genotypes a, b and d has been demonstrated in field studies. Mycoplasma hyopneumoniae: Onset of immunity: 3 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. Porcine circovirus type 2: Onset of immunity: 2 weeks after vaccination. Duration of immunity: 22 weeks after vaccination.

Contraindications

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

Adverse Reactions

Mild transient local reactions consisting of non-painful skin inflammations, are very common. These local reactions can be observed during the first week after vaccination and last for 1 to 3 days. One or two weeks later, these local reactions can reappear lasting for 1 to 7 days. A slight transient increase in body temperature (mean 0.3 °C, in individual pigs less than 1.5 °C) occurred commonly in field studies. This slight increase subsided spontaneously within 48 hours without treatment. If you notice any side effects, even those not already listed in the package leaflet or you think that the medicine has not worked, please inform your veterinarian.

TARGET SPECIES: Pigs.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION: For intradermal use. Administer one dose of 0.2 ml to pigs from 3 weeks of age onwards by intradermal administration at the sides of the neck using a suitable needle-free device able to administer 0.2 ml doses per shot.

ADVICE ON CORRECT ADMINISTRATION: Before use allow the vaccine to reach room temperature. Shake well before use.

WITHDRAWAL PERIOD(S): 21 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the sight and reach of children. Store and transport refrigerated (2 °C to 8 °C). Do not freeze. Keep the container in the outer carton in order to protect from light. Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Use immediately after the first opening of the container.

SPECIAL WARNING(S): Special warnings for each target species: Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals: If you are accidentally injected with this veterinary medicinal 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. 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. Overdose (symptoms, emergency procedures, antidotes): None known. Incompatibilities: Do not mix with any other veterinary medicinal product.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY: Medicines should not be disposed of via wastewater or household waste. Ask your veterinarian how to dispose of medicines no longer required. These measures should help to protect the environment.

OTHER INFORMATION: Pack sizes: Cardboard box with 1 PET vial of 50 doses (10 ml). Cardboard box with 1 PET vial of 100 doses (20 ml). Cardboard box with 1 PET vial of 125 doses (25 ml). Cardboard box with 1 PET vial of 250 doses (50 ml).

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

FOR VETERINARY USE ONLY

Est. Lic. No.: 4.242-E

Distributed in Canada: HIPRA ANIMAL HEALTH CANADA INC, 11 Holland Avenue, suite 605 - Ottawa, Ontario K1Y 4S1 - Tel 613.422.7610

Manufactured by: LABORATORIOS HIPRA, S.A., Avda. la Selva, 135 . 17170 Amer (Girona) SPAIN

Tel. (34) 972 43 06 60. Fax (34) 972 43 06 61. hipra@hipra.com

730523-20.1

05 -21

CPN: 1905009.0