AIVLOSIN- tylvalosin granule

Aivlosin by

Drug Labeling and Warnings

Aivlosin by is a Animal medication manufactured, distributed, or labeled by Pharmgate Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Do Not Feed Undiluted
For Further Manufacturing Only
For Use in Swine Feed Only

SPL UNCLASSIFIED SECTION

ACTIVE DRUG INGREDIENT: Tylvalosin 17% w/w (77.12 g tylvalosin/lb, equivalent to tylvalosin tartrate 19.4% w/w)

NADA 141-460 Approved by FDA.

VETERINARY INDICATIONS

INDICATION:

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

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE:

MIXING DIRECTIONS:

Swine:

Control of Porcine Proliferative Enteropathy

Preparation of Type B medicated feed containing 3,856 grams per ton (4,250 ppm) tylvalosin:

Prepare tylvalosin Type B medicated feed in mash form only.

To manufacture one ton of Type B medicated feed containing 3,856 g/ton (4,250 ppm) tylvalosin, mix 50 pounds of Aivlosin® 17% Type A Medicated Article with 1950 pounds of non-medicated feed.

Preparation of Type C medicated feed containing 38.6 grams per ton (42.5 ppm) tylvalosin:

To manufacture one ton of Type C medicated feed containing 38.6 g/ton (42.5 ppm) tylvalosin, mix 0.5 pound of Aivlosin® 17% Type A Medicated Article with 1999.5 pounds of non-medicated feed.

To aid in the even distribution of drug in the finished feed, add the full amount of Aivlosin® 17% Type A Medicated Article into a small portion of the feed and mix. Blend this mixture into the remainder of the feed and mix thoroughly. Pelleted or crumbled Type C medicated feeds must bear an expiration date of 1 week after the date of manufacture.

FEEDING DIRECTIONS: Feed Type C medicated feed containing 38.6 grams tylvalosin/ton as the sole ration for 14 consecutive days.

SPL UNCLASSIFIED SECTION

CAUTION: To assure both food safety and responsible use in swine, concurrent use of tylvalosin Type A medicated article in medicated feed and tylvalosin or another macrolide in medicated drinking water or by any other route of administration should be avoided. Not for use in swine intended for breeding. The effects of tylvalosin on swine reproductive performance, pregnancy, and lactation have not been determined. VFDs for tylvalosin shall not be refilled.

WARNINGS

WARNINGS:

WITHDRAWAL PERIOD:

No withdrawal period is required before slaughter for human consumption.

ANTIBACTERIAL WARNINGS:

Use of antibacterial drugs in the absence of a susceptible bacterial infection is unlikely to provide benefit to treated animals and may increase the development of drug-resistant bacteria.

USER SAFETY WARNINGS:

Not for use in humans. Keep out of reach of children.

May cause skin irritation. Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals. People with known hypersensitivity to tylvalosin should avoid contact with this product. In case of accidental ingestion or inhalation, seek medical attention. When handling Aivlosin® 17% Type A Medicated Article and preparing medicated feeds, avoid direct contact with the eyes and skin. Wear a dust mask, coveralls and impervious gloves when mixing and handling this product. Eye protection is recommended. In case of accidental eye exposure, wash eyes immediately with water and seek medical attention. If wearing contact lenses, immediately rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly and seek medical attention. In case of accidental skin exposure, wash contaminated skin thoroughly.

The Safety Data Sheet contains more detailed occupational safety information.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Use only as directed.

Distributed in the USA by: Pharmgate Animal Health, 1015 Ashes Drive, Wilmington, NC 28405.

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

To report suspected adverse drug events, contact the ASPCA Animal Product Safety Service at 1-800-345-4735 or the FDA at 1-888-FDA-VETS

Pharmgate Animal Health has contracted with the ASPCA Animal Product Safety Service to collect human and animal suspected adverse drug events reports for this product.

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

ECO Animal Health Limited, 78 Coombe Road, New Malden, Surrey, KT3 4QS, UK.

NDC: 51429-170-50

Net Contents:
50 LB (22.7 Kg)

PRINCIPAL DISPLAY PANEL - 22.7 kg Bag Label

NADA 141-460
Approved by FDA.

AIVLOSIN®17%
(Tylvalosin
Type A Medicated Article)

CAUTION: Federal law restricts medicated feed containing this
veterinary feed directive (VFD) drug to use by or on the order of
a licensed veterinarian

Do Not Feed Undiluted

For Further Manufacturing Only
For Use in Swine Feed Only

ACTIVE DRUG INGREDIENT:
Tylvalosin 17% w/w (77.12 g tylvalosin/lb, equivalent
to tylvalosin tartrate 19.4% w/w)

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

Distributed in the USA by: Pharmgate Animal Health, 1015 Ashes Drive, Wilmington, NC 28405.

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

To report suspected adverse drug events, contact the ASPCA Animal Product Safety Service at
1-800-345-4735 or the FDA at 1-888-FDA-VETS

Pharmgate Animal Health has contracted with the ASPCA Animal Product Safety Service to collect human
and animal suspected adverse drug events reports for this product.

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

ECO Animal Health Limited, 78 Coombe Road, New Malden, Surrey,
KT3 4QS, UK.

NET CONTENTS:
50 lb (22.7 kg)

NDC: 51429-170-50

PharmGate
Animal Health

INGREDIENTS AND APPEARANCE

AIVLOSIN 
tylvalosin granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 51429-170
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tylvalosin (UNII: 9T02S42WQO) (Tylvalosin - UNII:9T02S42WQO)	Tylvalosin	170 g  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51429-170-50	22.7 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141460	04/27/2016

Labeler - Pharmgate Animal Health (833270817)