PORCILIS® M HYO ID ONCE

For the active immunisation of grower pigs to reduce pulmonary lesions due to infection caused by Mycoplasma hyopneumoniae.

FOR ANIMAL USE ONLY

PORCILIS® M HYO ID ONCE

Reg. No. G4299 (Act 36/1947)

Emulsion for injection

INDICATIONS

Porcilis® M Hyo ID Once is indicated for the active immunisation of grower pigs to reduce pulmonary lesions due to infection caused by Mycoplasma hyopneumoniae.

COMPOSITION

Each dose of 0,2 mℓ contains inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: 1,0 PCVU1 inducing ≥ 6,5 log2 Ab* titre.

Adjuvants: 34,6 mg light liquid paraffin and 2,5 mg dl-α-tocopherol acetate.

1 Packed cell volume units

*Mean antibody titre (Ab) in mice

IMMUNITY

Onset of immunity:                                 3 weeks after vaccination

Duration of immunity:                           22 weeks for pigs

Porcilis® M Hyo ID Once is efficacious in the presence of maternally derived antibodies (MDA).

STORAGE INSTRUCTIONS

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Protect from direct sunlight.
  • Once the vial has been broached, the vaccine must be used within 3 hours.

WARNINGS

  • Withdrawal period: Do not slaughter pigs for human consumption within 21 days after vaccination.
  • Vaccinate healthy pigs only.
  • Do not use during pregnancy and lactation.
  • Vaccinate at least 21 days before breeding.
  • Do not mix Porcilis® M Hyo ID Once with any other veterinary medicinal product, except Porcilis® PCV ID, as mentioned under DIRECTIONS FOR USE.
  • Ensure that marketed animals do not have local reactions (swellings) at the site of vaccine administration or elevated temperature reactions (fever), as this may result in the condemnation of the carcasses.
  • Do not inject intravenously.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been extensively tested under a large variety of conditions,

failure thereof may ensue as a result of a wide range of reasons. If this is suspected,

seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • Adhere to the vaccination program to obtain optimum results.
  • Use entire contents when container is first opened and do not store unused contents and containers for future use.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).

Special precautions to be taken by the person administering Porcilis® M Hyo ID Once to pigs

To the user

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

To the physician

Porcilis® M Hyo ID Once 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 a tendon.

SIDE EFFECTS

The following side effects may be noticed, but will subside:

  • A transient increase in body temperature may occur on the day of vaccination. The

pigs return to normal 1 to 2 days after the peak temperature is observed.

  • Transient local reactions mostly consisting of hard, non-painful, button-like swellings, can be observed in the majority of the pigs for up to 21 days.
  • Redness and crusts at the local reaction, may be very commonly observed.
  • If any symptoms appear abnormal or do not subside, consult a veterinarian.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Shake well before use, and at regular intervals during the vaccination process.
  • Route of administration is via intradermal vaccination.
  • Ensure that all pigs are vaccinated.
  • Safety and efficacy data are available which demonstrate that Porcilis® M Hyo ID Once can be given with Porcilis® PCV ID, on the same day, from 3 weeks of age. The injection sites must be at least 3 cm apart.
  • Before using the vaccine, allow it to reach room temperature of 15 °C to 25 °C, by placing the vial in a suitable container containing 500 mℓ of water at 25 °C for 10 minutes, right before use.
  • Remove the aluminium overseal right before the vaccine is ready to use.

DOSAGE AND ADMINISTRATION

Once the vial has been broached, the vaccine must be used within 3 hours.

Administer 0,2 mℓ per pig intradermally, preferably at the sides of the neck, along the muscles of the back, using a multi-dose, needle-free intradermal device.

This device is for intradermal application of liquids, suitable to deliver a “jet-stream” volume of vaccine (0,2 mℓ ± 10 %), through the epidermal layers of the skin by using pressure (i.e., without a needle).

The vaccine vial is not opened for use but inserted into the intradermal device.

Safety and efficacy have been demonstrated using the device, IDAL.

Vaccination scheme: Vaccinate once from an age of 2 weeks onwards.

PRESENTATION

A white to nearly white emulsion, presented in 10 and 20 mℓ glass vials or polyethylene vials, closed with a rubber stopper and sealed with a coded aluminium cap.

Pack sizes: 50 or 100 doses filled in 10 or 20 mℓ vials may be packed single or in packs of

5 or 10 vials.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                      

Intervet South Africa (Pty) Ltd.                           

20 Spartan Road, Spartan

1619, RSA                                                                      

Tel: +27 (0) 11 923 9300                                          

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

29 October 2024