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Apralan (Canada)

This page contains information on Apralan for veterinary use.
The information provided typically includes the following:
  • Apralan Indications
  • Warnings and cautions for Apralan
  • Direction and dosage information for Apralan

Apralan

This treatment applies to the following species:
Manufacturer: Elanco

(apramycin sulfate)

Soluble Powder

VETERINARY USE ONLY

DIN 00818542

An antibiotic for oral use in pigs.

Active Ingredient: Each jar contains Apramycin Base (as apramycin sulfate) 50 g

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.

For treatment of colibacillosis, pigs should consume sufficient medicated drinking water to obtain 12.5 mg of apramycin activity per kg of body weight daily. Continue treatment for seven days.

A dual measure is pressed on to the bottle cap. The smaller measure provides a 4.4 mL dose (1 g apramycin activity) and the larger measure a 22 mL dose (5 g apramycin activity). Pour the powder into desired measure and tap gently to level it with the top of the measure. Add Apralan Soluble Powder to the only source of drinking water to provide the desired apramycin activity of 100 mg/litre. See following table:

Approx. Total Body wt. to be treated (kg)

Approx. Daily Water Consumption (litres)

Apramycin Activity (g)

Apralan Soluble Powder/Day

80

10

1

1 g (4.4 mL) measure

400

50

5

5 g (22 mL) measure

4000

500

50

Entire container

Add the appropriate quantity of Apralan Soluble Powder to five to ten times its own volume of water. Stir well and allow solution to stand for a few minutes, then stir again. When completely dissolved, add to the full volume of drinking water and stir well. Prepare fresh medicated drinking water every 24 hours to assure activity.

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.

Microorganism

Minimum Inhibitory Concentration1 (µg/mL)

Staphylococcus aureus

0.78

Streptococcus uberis

100.00

Group D Streptococcus

32.00

Group E Streptococcus

25.00

Pasteurella multocida

12.50

Mannheimia haemolytica

12.50

Brachyspira hyodysenteriae

10.00

Escherichia coli

3.12

Salmonella sp.

6.25

Klebsiella pneumoniae

0.78

Actinobacillus pleuropneumoniae

12.50

Proteus sp.

6.25

Arizona paracolon

6.25

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.

HOW SUPPLIED

Apralan Soluble powder is supplied in 84 g jars containing 50 g of Apramycin Base (as apramycin sulfate).

MANUFACTURER’S NAME AND ADDRESS

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

DATE: January 2018

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

Net:

 

 

84 g

AH0635

18Jan2018

CPN: 1231138.0

ELANCO CANADA LIMITED
(successor to Novartis Animal Health Canada Inc.)

RESEARCH PARK CENTRE, 150 RESEARCH LANE, SUITE 120, GUELPH, ON, N1G 4T2
Telephone:   519-821-0277
Customer Service:   800-387-6325
Fax:   519-821-7831
Every effort has been made to ensure the accuracy of the Apralan information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2018 Animalytix LLC. Updated: 2018-09-28

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