Tylan 200 Injection (Canada)

Tylosin Injection 200 mg/mL

DIN 00103594

FOR VETERINARY USE ONLY

ANTIBIOTIC

FOR USE IN BEEF CATTLE AND SWINE

Sterile

READ DIRECTIONS ON PULL-OUT LABEL FULLY BEFORE USE

Description

Tylosin is an antibiotic substance produced by a strain of Streptomyces fradiae, an actinomycete. Tylan 200 Injection is a sterile solution of tylosin base in 50% propylene glycol with 4% benzyl alcohol. Each mL contains 200 milligrams of tylosin activity.

PROPERTIES:

Tylosin is relatively non-toxic. The oral LD₅₀ in mice is greater than 5 grams per kilogram. In swine the LD₅₀ by intramuscular route is approximately 1,000 milligrams per kilogram; by the oral route greater than 5 grams per kilogram.

Other studies in dogs, cats and swine further substantiate the safety of this antibiotic. Blood level studies have been conducted in cattle and swine comparing Tylan 200 injection to aqueous solutions of tylosin tartrate. A longer duration of activity was evidenced with Tylan 200 injection. 24 hour levels can be expected in cattle with a single injection of this preparation. There has been no evidence of undue irritation in beef cattle at the site of injection.

Tylosin has an antibacterial spectrum that is essentially Gram-positive, but it is also active against certain gram negative organisms. It has also been found to be extremely active against Mycoplasma species.

Tylan 200 Injection Indications

BEEF CATTLE: Tylan 200 injection is effective for the treatment of pneumonia caused by strains of Pasteurella multocida and Actinomyces pyogenes susceptible to tylosin and contagious calf pneumonia and metritis caused by Actinomyces pyogenes.

SWINE: Tylan 200 injection is effective for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae, pneumonia caused by strains of Pasteurella multocida susceptible to tylosin and swine dysentery caused by Brachyspira hyodysenteriae (formerly Treponema hyodysenteriae) susceptible to tylosin.

TABLE I In Vitro Activity of Tylosin Against Several Microorganisms Isolated from Animals

*MIC = Minimum inhibitory concentration

Dosage and Administration

BEEF CATTLE: Inject intramuscularly a daily dose of 4 mL per 45 kg (100 lbs) body weight. This is the equivalent of 17.6 mg of tylosin per kg body weight (8 mg per pound body weight). Do not exceed 5 days of treatment. If no improvement is observed in 3 days, the diagnosis should be reconfirmed.

SWINE: Inject intramuscularly a daily dose of 0.5 to 2 mL per 45 kg (100 lbs) body weight. This is the equivalent of 2.2 to 8.8 mg of tylosin per kg body weight (1 to 4 mg of tylosin per pound body weight).

Do not exceed 3 days of treatment. If no improvement is observed in 3 days, the diagnosis should be reconfirmed.

NOTE:

For the most effective treatment of swine dysentery, inject with Tylan 200 injection and follow immediately with Tylan Soluble in the drinking water for 3-10 days at the rate of 1 gram per 4 litres (1 gram per U.S. gallon). To prevent a recurrence of swine dysentery, feed Tylan 10 Premix (tylosin phosphate) at the rate of 5 kg (110 g activity) per tonne of finished feed for 3 weeks. After 3 weeks the level should be reduced to 2 kg (44 g activity) per tonne of finished feed. Swine receiving drinking water containing Tylan Soluble or feed containing 110 g activity Tylan 10 Premix should not be slaughtered for use in food less than 48 hours following the latest treatment with this drug. No withdrawal is required when Tylan 10 Premix is included in feed at the 44 g activity per tonne of finished feed level. Swine dysentery appears sporadically in swine herds in this country. Tylan 10 Premix should therefore only be used for treatment and prevention of dysentery in swine following diagnosis of the disease in the herd.

CONDITIONS OF USE:

Do not mix Tylan 200 Injection with other injectable solutions as this may cause precipitation of the active ingredient.

Contraindications

There are no known contraindications at this time.

CAUTIONS:

Reactions to tylosin have been observed in sensitive animals. In swine, reactions have included oedema of rectal mucosa, mild anal protrusion, diarrhea, erythema and pruritus. Discontinuation of treatment effected an uneventful recovery. This product contains propylene glycol. Temporary irritation may occur at site of injection. Avoid injection of more than 5 mL at any one site in swine or more than 10 mL in cattle. To avoid excessive trim, do not slaughter swine for at least 21 days after treatment or cattle for at least 42 days after treatment.

Warnings

1. Do not use in lactating dairy cattle.

2. Treated animals must not be slaughtered for use in food for at least 21 days for cattle and 14 days for swine following the latest treatment with this drug.

3. When handling the product, avoid direct contact with skin or eyes.

4. KEEP OUT OF REACH OF CHILDREN.

Storage

Store in a cool place not exceeding 25°C.

How Supplied

Tylan 200 injection is supplied in 250 mL vials.

MANUFACTURER’S NAME AND ADDRESS:

Elanco Canada Limited, 1919 Minnesota Court, Suite 401 Mississauga, Ontario L5N 0C9

DATE: April 2022

Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates.

CPN: 1231150.2