Apralan (Canada)

Apramycin for Oral Solution (as Apramycin Sulfate)

552 IU/mg

VETERINARY USE ONLY

DIN 00818542

Soluble Powder

An antibiotic for oral use in pigs.

Active Ingredient: 1 g contains 552,000 IU apramycin (as apramycin sulfate).

READ DIRECTIONS ON PULL-OUT LABEL FULLY BEFORE USE.

Description

Apralan Soluble Powder is a water soluble preparation containing apramycin sulfate. Apramycin is a broad spectrum antibiotic of the aminocyclitol group, produced by the actinomycete Streptomyces tenebrarius. This compound is highly soluble in water, slightly soluble in the lower alcohols and essentially insoluble otherwise.

Apralan Indications

Weaning Pigs: For the treatment of bacterial enteritis caused by susceptible strains of Escherichia coli.

Apralan Dosage And Administration

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently.

Administer 12,500 IU apramycin sulfate per kilogram of body weight (corresponding to 22.5 mg of product per kg of body weight), daily for 7 consecutive days.

The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dose, the concentration of Apralan Soluble Powder has to be adjusted accordingly.

The weight of the animals should be determined as accurately as possible to avoid under dosing. Medicated water should be the only source of drinking. Medicated water must be renewed every 24 hours.

Animals with acute or severe clinical conditions that cannot drink, should receive adequate parenteral treatment.

The amount of product (mg) to be incorporated per 1 L of water should be established according to the following formula:

Apralan Caution

Drinking water and delivery system must be free of rust to avoid reduction of activity.

Not intended for use in pregnant or lactating animals.

Warnings

Treated animals must not be slaughtered for use in food for at least 28 days after the latest treatment with this drug.

When handling the product, avoid inhalation, oral exposure and direct contact with skin or eyes. In the event of skin contact, wash thoroughly with soap and water. In the event of accidental eye contact, wash the affected eye with fresh running water and seek medical attention if irritation persists.

Wash hands after use.

KEEP OUT OF REACH OF CHILDREN.

Adverse Reactions

No adverse reactions have been reported with the use of this product at recommended levels.

For technical support or to report a suspected adverse drug reaction, contact Elanco Canada Limited at 1-800-265-5475.

Other Information

IN VITRO ACTIVITY

In vitro tests demonstrate that apramycin is effective against certain Gram-positive and Gram-negative bacteria.

¹Data generated before 1990 by standard broth dilution microtiter test.

Commonly encountered Gram-negative enteric bacteria have been extensively studied for sensitivity to apramycin. Of a total of 758 Escherichia coli and Salmonella sp. isolated from animals in the United States, Europe, Taiwan and the Philippines, 738 (97.4%) were susceptible to 16 µg/mL or less of the antibiotic (data generated before 1990).

Microbiology

Apramycin, as other aminoglycoside-aminocyclitol antibiotics, acts against bacteria by exerting marked inhibitory effects on protein synthesis at the ribosome level. Apramycin has been shown to be a potent inhibitor of protein synthesis in bacteria². Apramycin inhibits the translocation step of protein synthesis and induces translation errors. At low concentrations, apramycin inhibits protein synthesis more effectively than kanamycin A, streptomycin, amikacin or gentamicin.

²Perzynski, S., et al. Effects of Apramycin, A Novel Aminoglycoside Antibiotic on Bacterial Protein Synthesis, Eur. J. Biochem. 99, 623-628 (1979).

Clinical Pharmacology

Apramycin is excreted by the kidney as the intact molecule. Apramycin is absorbed when administered orally to neonatal swine at single dosage levels of 10, 30 and 100 mg/kg with peak blood levels observed at one to four hours. Detectable serum levels persist for 12 to 24 hours. Considerable variation in post-administration blood levels is observed; however, the level detected is generally commensurate with the dose. Oral absorption of apramycin decreases markedly as pigs increase in age.

Safety

In acute toxicity studies in various species, no mortality was observed when apramycin was administered as a single gavage dose ranging from 520 mg/kg body weight (dog, chicken), to 5200 mg/kg (mice). Chronic toxicity studies have generated no effect levels of 50 ppm in dogs fed for one year, and 200 and 10000 ppm no effect levels when fed to mice and rats respectively for two years. No adverse effects on mutagenicity, teratology or reproduction have been observed in laboratory animals.

In swine, apramycin levels given as acute oral doses yielded no mortality at the highest tested level of 1250 mg/kg body weight. No adverse effects on reproductive performance have been observed.

Two studies were conducted to determine the effect of oral doses of apramycin sulfate upon the fecal consistency of baby pigs. In the first study, baby pigs were dosed with 50, 100 and 200 mg apramycin activity/pig in 2 mL of water on days one, two and three following birth. In the second study, baby pigs were dosed with 200 mg apramycin activity in 2 mL of water for three days starting on day one, three or five following birth. All treatments resulted in a decreased firmness of the feces except the single daily dose of 50 mg apramycin activity. All treated pigs gained more from birth to two weeks and had a higher percent survival than the controls.

Storage

Do not store above 25°C. Protect from moisture and excessive heat. Once opened, use within 28 days. Once diluted, use within 24 hours.

HOW SUPPLIED

Apralan Soluble Powder is supplied in 91 g jars. 1 g contains 552,000 IU apramycin (as apramycin sulfate).

MANUFACTURER’S NAME AND ADDRESS

Elanco Canada Limited, 150 Research Lane, Suite 120, Guelph, Ontario N1G 4T2

DATE: May 2019

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

CPN: 1231138.1