Increxxa Tulathromycin Injectable Solution Antibiotic, 100-mg, 250-ML

Increxxa Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin,a semi-synthetic macrolide antibiotic of the subclass triamilide.Each mL of Increxxa contains 100 mg of tulathromycin,500 mg propylene glycol, 19.2 mg citric acid and 5 mg monothioglycerol.Sodium hydroxide or hydrochloric acid may be added to adjust pH.Increxxa consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio.

Key Benefits:

• Quickly targets the site of infection in the lungs for fast-acting performance where it's needed.
• Provides a long half-life, giving cattle more time to bolster an effective defense against BRD.
• Rapidly circulates to the lungs to control BRD early in the disease process.
• Helps economically decrease the negative effects of BRD, such as morbidity and retreatment, leading to more profits by avoiding return trips to the pen and getting healthy cattle back on feed.

Indications:

Beef and Non-Lactating Dairy Cattle

BRD - Increxxa Injectable Solutionis indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Mycoplasma bovis.

IBK - Increxxa Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Root - Increxxa Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorumand Porphyromonas levii.

Suckling Calves,Dairy Calves,and Veal Calves

BRD - Increxxa Injectable Solution is indicated for the treatment of BRD associated with M.haemolytica, P.multocida, H.somni, and M.bovis.

Cattle

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Contraindications:

The use of Increxxa Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.

Precautions:

Cattle The effects of Increxxa on bovine reproductive performance, pregnancy, and lactation have not been determined. Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Swine The effects of Increxxa on porcine reproductive performance, pregnancy, and lactation have not been determined. Intramuscular injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

ADVERSE REACTIONS

Cattle In one BRD field study, two calves treated with tulathromycin injection at 2.5 mg/kg BW exhibited transient hypersalivation. One of these calves also exhibited transient dyspnea, which may have been related to pneumonia.

Swine In one field study, one out of 40 pigs treated with tulathromycin injection at 2.5 mg/kg BW exhibited mild salivation that resolved in less than four hours.

Storage Conditions:

Store below 25°C (77°F), with excursions up to 40°C (104°F).

100 mL: Use within 2 months of first puncture and puncture a maximum of 67 times. If more than 67 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.

250 mL: Use within 2 months of first puncture and puncture a maximum of 100 times. If more than 100 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.