Aivlosin: Product Information (Page 2 of 3)

Control of Porcine Proliferative Enteropathy (PPE):

A multi-location challenge model study was conducted to confirm the effectiveness of AIVLOSIN® Water Soluble Granules for the control of PPE associated with Lawsonia intracellularis. Pigs were challenged by intragastric gavage with a mucosal homogenate containing a North American isolate of Lawsonia intracellularis isolated in 2005 that induces representative disease in challenged pigs. When at least 15% of the study pigs were showing signs of infection based on abnormal fecal scores, pigs were provided water containing tylvalosin at an inclusion rate of 50 ppm for five consecutive days, or were provided non-medicated water. Effectiveness was evaluated using clinical scores (pig demeanor score, abdominal appearance score, and fecal score) and clinically-validated gross PPE lesion scores. A conclusion of the effectiveness of 50 ppm tylvalosin for the control of PPE was determined based on a statistically significant (p = 0.0103) improvement in the clinically-validated gross PPE lesion scores in the 50 ppm tylvalosin-treated group compared to the non-medicated group.

Control of Swine Respiratory Disease (SRD):

The effectiveness of Aivlosin® Water Soluble Granules for the control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, Streptococcus suis and Mycoplasma hyopneumoniae was investigated in a natural field infection study conducted in the United States (three study sites) and Canada (one study site). Day 0 was defined when at least 15% of the candidate pigs were deemed clinically affected with SRD (moderate or severe respiratory score, moderate or severe
depression score, and rectal temperature greater than or equal to 104.0 °F). On Day 0 a total of 980 pigs were enrolled and randomly assigned to a tylvalosin-treated group (50 ppm tylvalosin in drinking water for 5 consecutive days) or a non-medicated control group. Treatment success was evaluated on Day 7 and was defined as a pig with normal or mild respiratory score, normal or mild depression score, and rectal temperature less than 104.0 °F. The proportion of pigs meeting the definition of treatment success was numerically higher in the tylvalosin-treated group (48.5%) compared to the proportion of pigs meeting the definition of treatment success in the non-medicated control group (41.6%), and the observed difference was statistically significant (p=0.0353).

Additional data to demonstrate the effectiveness of Aivlosin® Water Soluble Granules for the control of SRD associated with Mycoplasma hyopneumoniae was obtained in an experimentally-induced infection model study. Two hundred and forty (240) commercial crossbred pigs were challenged endotracheally with a representative isolate of M. hyopneumoniae. One hundred and ninety-two (192) study pigs were randomly assigned to either a tylvalosin-treated group (50 ppm tylvalosin in drinking water for 5 consecutive days) or a nonmedicated control group. Treatment was started when at least four of eight randomly pre-selected sentinel pigs exhibited a minimum of 3% weighted gross lung lesions consistent with M. hyopneumoniae infection. After a 5-day treatment period and a 5-day post-treatment period, study pigs were euthanized and necropsy performed to determine lung lesion scores. The analysis included 95 tylvalosin-treated pigs and 93 nonmedicated control pigs. There was a statistically significant (P<0.0001) improvement in pen mean M. hyopneumoniae lung lesion scores in the 50 ppm tylvalosin treated pigs (5.1%) compared to negative control (10.9%).

ANIMAL SAFETY:

Margin of safety:

Aivlosin® Water Soluble Granules given orally in drinking water at 0, 50, 150 and 250 ppm tylvalosin (0, 1×, 3× and 5× the labeled dose, respectively) to 8 healthy pigs per treatment group over 15 days (3× the labeled duration) did not result in drug-induced clinical signs, gross pathologic lesions, histopathologic lesions or clinically-relevant clinical pathology abnormalities.

STORAGE:

Store in a cool dry place at or below 25°C (77°F).

HOW SUPPLIED:

Aivlosin® Water Soluble Granules is packaged in 160- and 400-gram sachets supplied in boxes holding 10 and 5 sachets respectively.

LOT NO.: Printed on label.
EXPIRY: Printed on label.

Distributed in the USA by:
Pharmgate Animal Health LLC.
14040 Industrial Road,
Omaha, NE 68144
www.pharmgateah.com

For technical assistance or to obtain a Safety Data Sheet, call Pharmgate Animal Health LLC. at 1-800-380-6099

Aivlosin® is a registered trademark of ECO Animal Health Ltd.

PRINCIPAL DISPLAY PANEL — 160 g Packet and Carton

NDC 51429-625-16

AI VLOSIN®
(62.5% w/w Tylvalosin as
Tylvalosin Tartrate)Water Soluble Granules

For use only in the drinking water of swine intended for slaughter. Not for use in lactating or pregnant females, or males and females intended for breeding.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS: Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.

Control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica , Haemophilus parasuis, Pasteurella multocida, Streptococcus suis , and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD.

Read Product Information provided in the package insert carefully for complete details.

DOSAGE AND ADMINISTRATION: Prepare drinking water containing 50 parts per million Tylvalosin. Add Aivlosin® Water Soluble Granules to drinking water as illustrated in the following table.

Aivlosin® Water Soluble Granules sachet size160 grams
Tylvalosin content of sachet (grams)100
Recommended volume of stock solution (US gallons)4
Volume of drinking water (US gallons)528
Final tylvalosin inclusion rate in drinking water50 parts per million (ppm)

Administer continuously in drinking water for five (5) consecutive days.

Keep water supply equipment clean and in good operating condition. Clean water medication equipment before and after each use. Do not mix or administer tylvalosin medicated water using equipment made of galvanized metal. Galvanized metal adversely affects the stability of tylvalosin in water and may reduce the effectiveness of the product.

Prepare a fresh batch of medicated stock solution or medicated drinking water daily.

MIXING DIRECTIONS: See Product Information provided in the package insert for details.

For technical assistance or to obtain a Safety Data Sheet, call Pharmgate Animal Health LLC. at 1-800-380-6099
To report suspected adverse reactions in animals, contact Pharmgate Animal Health LLC. at 1-833-531-0114.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.

Aivlosin® is a registered trademark of ECO Animal Health Ltd.

Net contents: 160 grams

Aivlosin® Water Soluble Granules

Approved by FDA under NADA # 141- 336

PharmGate Animal Health

160 gram sachet label
(click image for full-size original)

PACKAGE CONTENTS: Box contains 10 x 160-gram sachets

10 x 160 gram sachet carton label
(click image for full-size original)

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