Animal NDC 46066-504-48 Tylosin Tartrate
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 46066-504-48 |
| Proprietary Name | Tylosin Tartrate 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 | Tylosin Tartrate 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 | Aspen Veterinary Resources, Ltd |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED 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 | ANADA200455 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. |
Tylosin Tartrate Images
Tylosin Tartrate 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
Indications & Usage
A Macrolide Antibiotic
For Use in Chickens, Turkeys, Swine and Honey Bees Only
Ingredient: Tylosin (as Tylosin Tartrate)...........100 g
INDICATIONS:
Chickens: As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of CRD associated with Mycoplasma gallisepticum sensitive to tylosin at the time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.
Turkeys: For the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.
Swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A medicated article in feed. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A medicated article in feed.
Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).
Warnings
WARNINGS
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
General Precautions
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Restricted Drug (California) - Use only as Directed
TAKE TIME OBSERVE LABEL DIRECTIONS
Dosage & Administration
DOSAGE AND ADMINISTRATION:
Chickens and Turkeys: To assure thorough dissolution, place the Tylosin Tartrate Soluble Powder (contents of this pouch) in a mixing container and add one gallon of water (3700 ml) to the material. Mix this concentrated solution with water to make 50 gallons (189 liters) of treated dinking water.
Swine: To assure thorough dissolution, place the Tylosin Tartrate Soluble Powder (contents of this pouch) in a mixing container and add one gallon of water (3700 ml) to the material. Mix this concentrated solution with water to make 400 gallons (1514 liters) of treated drinking water resulting in 250 mg/gallon.
| Species | Desired Concentration in Drinking Water (mg/gallon) | Pouches of Tylosin Tartrate Soluble Powder | Gallons of water to make Stock Solution |
| Chickens/Turkeys | 2,000 | 10 | 3.9 |
| Swine | 250 | 1 | 3.1 |
*This table applies only if the water medicating pump is set to deliver 1 ounce of stock solution per gallon of drinking water.
Honey Bees: Mix 200 mg tylosin in 20 g confectioners/powdered sugar. Use immediately.
When directed to mix the product with water, always add the water to the powder. Do not pour the powder into the water. Prepare a fresh Tylosin Tartrate Soluble Powder solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves.
Instructions For Use
DIRECTIONS FOR USE:
Chickens should be treated for three days; however, treatment may be administered for one to five days depending upon severity of infection. Treated chickens must consume enough medicated water to provide 50 mg per pound of body weight per day. Only medicated water should be available to the birds.
Turkeys should be treated for three days; however, treatment may be administered for two to five days depending upon severity of infection. Treated turkeys must consume enough medicated water to provide 60 mg per pound of body weight per day. Only medicated water should be available to the birds.
Swine: For the treatment and control of swine dysentery medicate with 250 mg tylosin per gallon in drinking water for 3 to 10 days, depending upon severity of infection. Alternatively, medicate with 250 mg tylosin per gallon in drinking water for 3 to 10 days, followed by 40 to 100 g tylosin per ton of complete feed (Type C medicated feed manufactured from tylosin phosphate Type A medicated article) for 2 to 6 weeks. For control of porcine proliferative enteropathies (PPE, ileitis) medicate with 250 mg tylosin per gallon in drinking water for 3 to 1 0 days, followed by 40 to 1 00 g of tylosin per ton of complete feed (Type C medicated feed manufactured from tylosin phosphate Type A medicated article) for 2 to 6 weeks. Swine must consume enough medicated water to provide a therapeutic dose. Only medicated water (250 mg tylosin per gallon) should be available while medicating with Tylosin Tartrate Soluble Powder.
Honey Bee colonies should receive three treatments administered as a dust in confectioners/powdered sugar. The 200 mg dose is applied (dusted) over the top bars of the brood chamber once weekly for 3 weeks.
User Safety Warnings
USER SAFETY WARNINGS: Avoid contact with human skin. Exposure to tylosin may cause a rash.
Residue Warning
RESIDUE WARNINGS: Chickens must not be slaughtered for food within 24 hours after treatment. Turkeys must not be slaughtered for food within five days after treatment. Swine must not be slaughtered for food within 48 hours after treatment. Do not use in layers producing eggs for human consumption. Honey Bees: The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks prior to main honey flow.
Storage And Handling
Store at room temperature 25°C ( 77°F). Excursions permitted to 40°C. Avoid Moisture.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.