TULISSIN^® 100 :Tulathromycin Injectable Solution for Pigs

TULISSIN^® 100 injectable solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of Tulissin^® 100 injectable solution contains 100mg of tulathromycin.

 

KEY CHARACTERISTICS

Tulissin^® 100 (tulathromycin injection) provides a new standard of performance, flexibility, and convenience for managing respiratory disease.

Tulathromycin, a first choice therapy¹ for treating Swine Respiratory Disease (SRD):

• Goes to work in minutes²
• Concentrates in the most susceptible areas of the respiratory system
• Provides nine days of lung activity to treat and control Swine Respiratory Disease.
• Convenient dosages with availability Tulissin^® 25 (tulathromycin injection) for use in smaller pigs with the same pre-slaughter withdrawal time of five days.

Tulathromycin is a semi-synthetic macrolide antimicrobial. Tulathromycin and other macrolide antibiotics (Tulathromycin A & B) inhibit bacterial protein synthesis resulting in bacterial death.

 

Hazard Classification

Tulathromycin (CAS: 217500-96-4) is not listed on the NOHSC Hazardous Substances Information System (HSIS) database (NOHSC, 2005). Based on the product toxicology information and concentration of Tulathromycin and other ingredients in the product (90%), the OCS has classified Tulissin 100^® Injectable Solution is determined to be a hazardous substance in accordance with NOHSC Approved Criteria for classifying Hazardous Substances (NOHSC, 2004) with the following risk phrase:

R10    Flammable

 

Use and Exposure

Tulissin 100^® Injectable Solution is intended as a single intramuscular or subcutaneous treatment of bacterial respiratory diseases in cattle and pigs. The product will be manufactured and formulated overseas in  20, 50, and 100ml sealed glass vials with serum stopper closure and aluminum overseal with a flip-off button. Therefore, occupational exposure is unlikely during manufacture and formulation.

Veterinarians will administer the end-use product. Their exposure while administering the product is limited to accidental self-injection or through ocular contact with the product when air bubbles are being cleared from the syringe. Post-application exposure is not applicable. The likelihood of repeated exposure will be restricted to trained professionals who will be aware of the possible toxicity associated with the product.

 

Environmental Fate and Toxicity

Tulathromycin is a white to off-white solid that exists in anhydrous, monohydrate and sesquihydrate forms. It is soluble in most organic solvents and is highly soluble in water below pH of 8 (400g/L) and still at pH 9 (19 g/L). The pKa values of 8.49, 9.28 and 9.80 indicate that, except in alkaline solution or soil -- Tulathromycin is likely to be ionized and to be relatively mobile.

 

Dosage and Administration

In shelf life: Use within 28 days of broaching the vial.

Pigs: 1ml/40 kg body weight (2.5 mg tulathromycin/kg) by a single intramuscular injection in the neck. For pigs over 100 kg body weight, divide the dose so that no more than 2.5ml are injected at one site.

 

Withholding Periods

Pigs: DO NOT USE less than 14 days before slaughter for human consumption.

Treat and Control for the Treatment of Swine Respiratory Disease (SRD)

• Treat: Tulissin 100^® injectable solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae.  Do not inject more than 4 mL per injection site. Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.
• Control: Tulissin 100^® injectable solution is indicated for the control of SRD associated Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. Not use in animals previously found to be hypersensitive to the drug.

 

Withdrawal Period

Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.

 

Packaging

Tulissin^®100 Injectable Solution is available in the following package sizes: 50ml vial; 100ml vial; 250ml vial; 500ml vial

 

Formulation

100 mg of tulathromycin/mL