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

Emulsion for injection

Reg. No. G4299 (Act 36/1947)

Only for use by or under the supervision of persons registered in terms of, or authorised in terms of, Section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

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.

IMMUNITY

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 22 weeks for pigs.

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. *

34,6 mg light liquid paraffin

2,5 mg dl-α-tocopherol acetate

1 Packed cell volume units

*Mean antibody titre (Ab) in mice.

STORAGE

  • Store between 2 °C to 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 animals for human consumption for at least 21 days after vaccination.
  • Vaccinate healthy animals only.
  • Do not use during pregnancy and lactation. Vaccinate at least 21 days before breeding.
  • 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 store partially used containers for future use, and use the entire contents once opened.
  • 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.

SPECIAL WARNINGS

To the user

Porcilis® M Hyo ID Once contains a mineral oil. Accidental self-injection may result in

severe pain and swelling, particularly if administered 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 accidently injected with this product, seek prompt medical advice even if only a very small amount is administered 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

Porcilis® M Hyo ID Once contains mineral oil. Even if small amounts have accidental been injected, 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.

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 vaccine administration equipment.
  • 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 vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Adhere to the vaccination program to obtain optimum results.

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

animals 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 and

can be observed in the majority of the animals for up to 21 days.

Consult a veterinarian if symptoms persist.

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 animals are vaccinated.
  • For the vaccination of grower pigs.
  • Safety and efficacy data are available which demonstrate that Porcilis® M Hyo ID Once can be given with Porcilis® PCV ID at different sites on the same day from 3 weeks of age.
  • The possible side effects are as presented above. If any symptoms appear abnormal or do not subside, a veterinarian should be consulted.
  • Do not mix with any other veterinary medicinal product, except Porcilis® PCV ID as stated above.
  • 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 just before use.
  • Remove the aluminium overseal just before the vaccine is ready for use.

DOSAGE AND ADMINISTRATION

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

Intradermal administration of 0,2 mℓ per animal preferably at the sides of the neck along

the muscles of the back using a suitable intradermal device.

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

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

The container is not opened for use but inserted into the intradermal device. Using the

intradermal device, the vaccine is administered using pressure (i.e., without a needle).

PRESENTATION

Porcilis® M Hyo ID Once is presented in 10 and 20 mℓ glass vials closed with a rubber stopper and sealed with a coded aluminium cap.

Porcilis® M Hyo ID Once is presented in 20 mℓ 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 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

6 December 2018