ZACTRAN Injectable Solution is a ready-to-use sterile parenteral solution containing gamithromycin, a macrolide sub-class, 7a-azalide antimicrobial. Each mL of ZACTRAN Injectable Solution contains 150 mg of gamithromycin, 40 mg of succinic acid, 1 mg of monothioglycerol and glycerol formal q.s. ad 1 mL.
ZACTRAN Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (Haemophilus somnus) and Mycoplasma bovis. ZACTRAN Injectable Solution is also indicated for the reduction of morbidity associated with BRD in feedlot calves, caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, during the first 10 days in the feedlot, when administered at the time of arrival.
DOSAGE AND ADMINISTRATION:
Administer a single subcutaneous injection in the neck at a dose of 6 mg gamithromycin/kg body weight (equivalent to 1 mL/25 kg body weight).
For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 mL are injected at one site.
Most animals will respond to treatment within 3 to 5 days. If no improvement is observed, the diagnosis should be re-evaluated.
Note: To limit the development of antimicrobial resistance, ZACTRAN Injectable Solution should only be used as an arrival treatment when: 1) BRD has been diagnosed and 2) calves are at «high risk» of developing BRD. One or more of the following factors typically characterizes calves at «high risk» of developing BRD. Cattle are from multiple farm origins, and/or cattle have extended transport times (that may have included few if any rest stops), and/or ambient temperature change(s) from origin to arrival of 17°C or more, and/or cattle have experienced excessive shrink or stressful processing procedures such as castration and dehorning.
In a target animal safety study in six-month old beef calves, ZACTRAN Injectable Solution was administered by subcutaneous injection at 6, 18 and 30 mg/kg body weight (1, 3 and 5 times the labeled dose) on day 0, 5 and 10. Animals were clinically evaluated up to Day 15.
In overdosed groups, transient indications of pain after injection were seen, including head twists, pawing at the ground or attempts to lick the injection sites.
Dose related swellings characterized by skin thickening and discolouration of subcutaneous tissue were observed at the injection site, as well as related microscopic changes.
No other clinically significant drug-related effects were observed.
Treated cattle must not be slaughtered for use in food for at least 49 days after the latest treatment with this drug. Do not use in lactating dairy cattle. Do not use in gestating cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition. To limit the development of antimicrobial resistance, ZACTRAN Injectable Solution should only be used as an arrival treatment in feedlot calves when BRD has been diagnosed and calves are at high risk of developing BRD.
Not for use in humans. Keep out of reach of children. Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If skin exposure occurs, wash the affected area immediately with clean water. Consult a physician in case of accidental injection or ingestion by humans. Wash hands after use.
The effects of ZACTRAN Injectable Solution on reproductive performance, pregnancy and lactation have not been determined.
Subcutaneous injection can cause a local tissue reaction that may result in trim loss of edible tissue at slaughter.
Do not use in case of hypersensitivity to macrolide drugs. Do not use this product simultaneously with other macrolides or antibiotics known as lincosamides.
Transient injection site swellings with occasional slight pain have been observed in some animals.
No systemic adverse drug reactions were observed during clinical field studies.
Store at 15 – 30°C. Do not freeze. Discard all unused portions 28 days after opening the vial.
ZACTRAN Injectable Solution is available in multidose 100 mL, 250 mL and 500 mL vials. Not all pack sizes maybe marketed.