Apotil

1 x 50 ml

Liquid for injection, solution

Active substance

Tilmicosin : 300 mg/ml

ATC code

QJ01FA91 Tilmicosin

QJ01FA Macrolides

QJ01F Macrolides, lincosamides and streptogramins

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle and sheep

Indications

Cattle

Treatment of bovine respiratory disease associated with Mannheimia haemolytica, and Pasteurella multocida.

Treatment of interdigital necrobacillosis (bovine pododermatitis, foul in the foot).

Sheep

Treatment of respiratory tract infections caused by Mannheimia haemolytica and Pasterurella multocida.

Treatment of foot rot caused by Dichelobacter nodosus and Fusobacterium necrophorum..

Treatment of ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae.

Dose to be administered and administration route

INJECTION OF TILMICOSIN IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION.

For subcutaneous injection only.

Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Apotil 300 mg/ml per 30 kg body weight).

Cattle: method of administration

Withdraw the required dose from the vial and remove the syringe from the needle. When a group of animals is to be treated, leave the needle in the vial to remove the subsequent doses. Restrain the animal and insert a separate needle subcutaneously into the injection site, preferablyin a skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skin fold. Do not inject more than 20 ml per injection site.

Sheep: method of administration

Accurate weighing of lambs is important to avoid overdosing. The use of a 2-ml or smaller syringe improves accurate dosing.

Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial. Restrain the sheep whilst leaning over the animal and insert a separate needle subcutaneously into the injection site, which should be in a skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skinfold. Do not inject more than 2 ml per injection site.

If no improvement is noted within 48 hours, the diagnosis should be confirmed.

Avoid introduction of contamination into the vial during use. The vial should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vial.

Adverse reactions

Occasionally, a soft diffuse swelling may occur at the injection site, but this disappears within five to eight days.

Deaths of cattle have been observed following a single intravenous dose of 5 mg/kg, and following the subcutaneous injection of doses of 150 mg/kg at 72 hour intervals. In pigs, intramuscular injection at 20 mg/kg has caused deaths. Sheep have died following a single intravenous injection of 7.5 mg/kg.