Reg. No. G 2848  Act/Wet 36/1947

For use as an aid in the control and prevention of disease associated with canine parainfluenzavirus and Bordetella bronchiseptica infection in healthy dogs 3 weeks of age and older.  These organisms have been implicated in the aetiology of infectious canine tracheobronchitis (kennel cough).

Storage:

• Store in the dark between 2 °C and 7 °C.  Do not freeze.
• Allow the vaccine to reach room temperature (20 °C to 25 °C) before use.
• Avoid prolonged or repetative exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• The Sterile Diluent may be stored at room temperature (20 °C to 25 °C).
• Protect from direct sunlight.

Contents:
Each 1,0 mℓ dose of Intra-Trac-II contain at least 104,9 TCID50 of canine parainfluenzavirus and 2,6 x 106 CFU Bordetella bronchiseptica with stabilizer.

Warnings:

• Do not freeze.
• Destroy any unused vaccine by, for example, burning, and dispose of all vaccine containers after vaccination.
• Do not open and reconstitute until ready to start vaccination.
• Use the vaccine immediately after reconstitution.
• Do not store partially used containers for future use and use the entire contents when opened.
• Use according to the number of doses as indicated on the label.
• Systemic reactions resulting from inadvertent intramuscular or subcutaneous injection have been reported.  Symptoms may include vomiting, diarrhea, lethargy, inappetence, jaundice and death associated with liver failure.  Localized tissue necrosis at the site of the injection site has also been reported.  If inadvertent injection occurs, monitor the dog closely.  Supportive therapy including IV fluids and treatment with gentamicin, tetracycline or trimethoprim/sulphonamide may be indicated.
• If anaphylactoid reaction occurs, use epinephrine.
• Post vaccinal reactions consisting of mild canine kennel cough syndrome may occur following use of the vaccine.
• Keep out of reach of children and uninformed persons.
• 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:

• Only healthy dogs and puppies should be vaccinated.
• Do not mix the vaccine with other vaccines.
• Observe aseptic precautions.  Ensure that vaccination equipment (needles, syringes etc.) are clean and sterile prior to use.  Avoid contamination of the vaccine with traces of disinfectant and spirits.
• Ensure that all equipment is kept clean and sterile during vaccination.
• Ensure that the freeze-dried plug is completely dissolved in the desired volume of diluent.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

Directions for use:
Use only as directed.
Vaccinate healthy dogs and puppies at 3 weeks of age and older.

Preparation of the vaccine

• Reconstitute the vaccine as follows: 
  For 1 mℓ dose reconstitute with 1 mℓ of sterile diluent or for one 0,5 mℓ dose, reconstitute with 0,5 mℓ sterile diluent.
• Draw the vaccine back into the syringe.
• Remove the needle from the syringe.
• Apply the nasal applicator tip to the syringe.

Dosage for administration:

• The standard dose is 1 mℓ administered intranasally.
• The vaccine may be reconstituted with less than 1 mℓ of diluent to mininize discomfort when vaccinating small dogs and puppies.
• Instil the reconstituted vaccine into one or both nostrils as illustrated below.
• Annual vaccination is recommended.

Presentations:
Cardboard cartons containing 10 x 1 dose, 150 x 1 dose and 2 x 5 doses with 1 mℓ or 5 mℓ sterile diluent.

Registration holders:

Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07