Engemycin DD (Canada)

Oxytetracycline injection, Mfr. Std., 100 mg/mL

CONTAINS ANTIMICROBIAL

USE RESPONSIBLY

Sterile

DIN 02304236

Veterinary Use Only

Antibiotic, ATCvet code QJ01AA06

Description: Engemycin^® DD is a sterile, clear, green to yellow solution of oxytetracycline hydrochloride for intramuscular or intravenous administration. Each mL contains 100 mg oxytetracycline base (as hydrochloride) and 5.00 mg sodium formaldehyde sulfoxylate as antioxidant in an aqueous povidone base.

Indications: Engemycin DD is indicated for the treatment of infections caused by oxytetracycline-susceptible organisms in cattle, swine and sheep.

Cattle: bacterial pneumonia, pasteurellosis (associated with shipping fever complex), mastitis,

metritis, calf scours (bacterial enteritis), foot rot, navel ill, calf diphtheria, leptospirosis, blackleg/malignant edema, peritonitis and joint ill.

Swine: Erysipelas, bacterial enteritis, leptospirosis, mastitis, metritis and bacterial pneumonia.

Sheep: Bacterial pneumonia, pasteurellosis, mastitis, metritis and joint ill.

Directions for Use:

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently and for the shortest duration required to achieve the desired clinical outcome.

Administer by intramuscular or intravenous injection at a dosage of 6.7 mg/kg (3 mL per 45 kg) body weight once daily for 2-3 days. For intravenous administration, Engemycin DD should be diluted with sterile isotonic saline, dextrose or similar solutions. For this, use 25 mL Engemycin DD to each 100 mL or more of diluent and administer slowly. Do not inject more than 20 mL of Engemycin DD intramuscularly at one site. In lactating dairy cattle, no more than 10 mL should be injected intramuscularly at one injection site. Higher blood levels can be achieved following I.V. administration of this dosage.

Cautions:

Tetracycline resistance in various bacteria including target pathogens are frequently high. Use of Engemycin DD should be based an susceptibility testing because of reported high tetracycline resistance in bacteria from cattle, swine and sheep. Inappropriate use of Engemycin DD may increase the prevalence of bacteria resistant to tetracyclines and may decrease their effectiveness.

Occasional sensitivity reactions have been observed following the parenteral administration of oxytetracycline. If such side effects occur, discontinue use of the drug immediately. Epinephrine solution given intramuscularly is indicated.

Shock may occur as a result of rapid intravenous injection.

Warnings:

Treated cattle must not be slaughtered for use in food for at least 21 days after the latest treatment with this drug.

Treated swine and sheep must not be slaughtered for use in food for at least 18 days after the latest treatment with this drug.

Milk taken from treated animals during treatment and for 84 hours after the latest treatment with this drug must not be used as food.

When handling this drug, caution should be taken to avoid accidental self-injection and direct contact with eyes and skin.

To limit the development of antimicrobial resistance, the choice of this drug as the most appropriate treatment should be confirmed by clinical experience supported, where possible, by pathogen culture and drug susceptibility testing.

Keep out of reach of children.

Adverse Reactions:

Although not all adverse reactions are reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse reactions listed here reflect reporting and not necessarily causality. All adverse reactions were reported as very rare events (reported in less than 1 in 10,000 animals exposed). Adverse events are listed by body system, in decreasing order of frequency:

Systemic disorders: death, lack of efficacy, recumbency

Immune system disorders: anaphylaxis, allergic-type reaction

Respiratory tract disorders: difficulty breathing, fast breathing

Clinical Pharmacology:

Oxytetracycline is a bacteriostatic antibiotic which has broad spectrum antibacterial activity against both gram-positive and gram-negative bacteria. However, high-level tetracycline resistance is frequently reported in various bacteria (target pathogens and foodborne bacteria). Multiple genes have been identified which mediate resistance to tetracyclines and these genes may be carried on plasmids or transposons between both pathogenic and non-pathogenic bacteria. Resistance to one tetracycline confers cross resistance across the tetracycline class.

Absorption and Excretion: By intravenous injection, immediate therapeutic blood levels are achieved. By intramuscular injection, therapeutic levels are achieved within two hours. These levels persist for 24 hours or longer. Further, oxytetracycline diffuses readily into the tissues, so that high concentrations are found in the lungs and mammary gland, as well as in the urine, feces and milk. For this reason, parenteral therapy is ideally suited in the treatment of pneumonia, enteritis, mastitis and many other systemic conditions.

Storage: Store at 15-30°C. Do not freeze. Use within 28 days of first puncture and puncture a maximum 28 times with 18G needle.

How supplied: ENGEMYCIN DD is individually packaged in 100 or 250 mL vials.

Version: 10 December 2024

Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866 683-7838

^® Registered trademark of Intervet International B.V. Used under license.

231652 R3

CPN: 1208348.0