Animal NDC 51429-170-50 Aivlosin
Tylvalosin

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-170-50
Proprietary Name Aivlosin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Tylvalosin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Pharmgate Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    INDICATION:
Active Ingredient(s)
  • Tylvalosin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141460 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Aivlosin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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)

NADA 141-460 Approved by FDA.

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

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 Type C medicated feeds must bear an expiration date of 30 days after the date of manufacture.

Crumbled Type C medicated feeds must bear an expiration date of 7 days 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.

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.

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.

Restricted Drug (California) - Use only as directed.

Distributed in the USA by: Pharmgate Animal Health, LLC 14040 Industrial Road, Omaha, Nebraska 68144

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 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.

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)


Veterinary Indications



INDICATION:


Dosage & Administration



DIRECTIONS FOR USE:


Warnings



WARNINGS:


Safe Handling Warning



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).


Principal Display Panel - 22.7 Kg Bag



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, LLC, 14040 Industrial Road, Omaha, Nebraska 68144.

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)

Pharmgate
ANIMAL HEALTH

NDC 51429-170-50


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.