Label: TYLOVET SOLUBLE- tylosin tartrate powder, for solution
- NDC Code(s): 23243-2220-1
- Packager: Huvepharma, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated January 3, 2023
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- SPL UNCLASSIFIED SECTION
- PRECAUTIONS
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VETERINARY INDICATIONS
Indications
Chickens: For the control of mortality caused by necrotic enteritis (NE) associated with
Clostridium perfringens in broiler chickens. As an aid in the treatment of chronic respiratory
disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens.
For the control of CRD associated with Mycoplasma gallisepticum at the time of vaccination or
other stress in chickens. For the control of CRD associated with Mycoplasma synoviae 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 (SD) associated with Brachyspira
hyodysenteriae. For the treatment and control of SD associated with Brachyspira
hyodysenteriae when followed immediately by Tylovet Type A medicated article in feed. For
the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia
intracellularis when followed immediately by Tylovet Type A medicated article in feed.
Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).Ingredients
Tylosin (as tylosin tartrate) ………………………………………… 100 g -
DOSAGE & ADMINISTRATION
Dosage and Administration
Dosages:
Chickens:
NE indication: 851 to 1,419 mg/gallon (225 to 375 ppm) in drinking water.
CRD indications: 2,000 mg/gallon (528 ppm) in drinking water.
Turkeys: 2,000 mg/gallon (528 ppm) in drinking water.
Swine: 250 mg/gallon (66 ppm) in drinking water.
Honey Bees: 200 mg/colony in confectioners/powdered sugar.
Mixing Directions for Medicated Drinking Water:
Always add the water to the powder. Do not pour the powder into the water. Prepare a fresh
Tylovet Soluble solution every three days. When mixing and handling tylosin, use protective
clothing and impervious gloves. If using a water medicating pump see table below, otherwise
mix as follows:
To assure thorough dissolution, first place the contents of one pouch in a mixing container and
add one gallon of water (3785 mL) to the powder to make a concentrated solution. To make
medicated drinking water containing 250 mg/gallon (66 ppm), mix this concentrated solution
with water to make 400 gallons (1514 liters) of medicated drinking water. To make medicated
drinking water containing 851 to 1,419 mg/gallon (225 to 375 ppm), mix this concentrated
solution with water to make from 117 gallons + 51 ounces (444 liters) to 70 gallons + 64 ounces
(267 liters) of medicated drinking water, respectively. To make medicated drinking water
containing 2,000 mg/gallon (528 ppm), mix this concentrated solution with water to make 50
gallons (189 liters) of medicated drinking water. -
GENERAL PRECAUTIONS
Restricted Drug (California) - Use Only as Directed.
To report suspected adverse drug events, for technical
assistance or to obtain a copy of the Safety Data Sheet
(SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
www.huvepharma.us. For additional information about
adverse drug experience reporting for animal drugs, contact
FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.Manufactured for: Huvepharma Inc.
Peachtree City, GA 30269, Made in Bulgaria
Tylovet® is a registered trademark of Huvepharma EOOD Rev. 06-2022
Lot: 00000000000 Exp. Date: 00.0000 Code: LB444v5-Tyl100-USA0622 -
DOSAGE & ADMINISTRATION
Mixing Directions for Water Medicating Pump (1:128 inclusion)*:
Desired Concentration
in Drinking water
Pouches of
Tylovet Soluble
Volume of Water to Make
Stock Solution
250 mg/gallon (66 ppm)
1
3 gallons + 13 ounces
851 mg/gallon (225 ppm)
5
4 gallons + 77 ounces
1,419 mg/gallon (375 ppm)
9
5 gallons + 0 ounces
2,000 mg/gallon (528 ppm)
10
3 gallons + 115 ounces
*This table applies only if the water medicating pump is set to deliver 1 ounce of stock solution
per gallon of drinking water.
Mixing Directions for use in Honey Bees: Mix 200 mg tylosin in 20 g confectioners/powdered
sugar. Use immediately. -
INSTRUCTIONS FOR USE
Directions for Use
Chickens:NE indication: Administer medicated drinking water for a single five day period in broiler
chickens. To assure all birds receive the intended medication, only medicated water should be
available. These practices should be followed to assure both food safety and responsible
antimicrobial drug use in chickens: 1) Use in flocks exhibiting signs of a necrotic enteritis outbreak,
for example, increased mortality and lesions characteristic of necrotic enteritis upon necropsy; 2)
Administer the full dose and dosing regimen once medication is initiated; 3) Use of Tylovet Soluble
or another macrolide is not advised if additional therapy is needed beyond the original course of
medication. CRD indications: Administer medicated drinking water for three days; however,
medicated water 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: Administer medicated drinking water for three days; however, medicated water 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: SD indication: Administer medicated drinking water for 3 to 10 days, depending upon
severity of infection. Alternatively, administer medicated 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 Tylovet
Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while
medicating with Tylovet Soluble. PPE indication: Administer medicated drinking water for 3 to 10
days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed
manufactured from Tylovet A medicated article) for 2 to 6 weeks. Only medicated water should be
available to swine while medicating with Tylovet Soluble.
Honey Bee Colonies: Administer three treatments of medicated confectioners sugar once weekly
for 3 weeks. The 200 mg dose is applied (dusted) over the top bars of the brood chamber. - USER SAFETY WARNINGS
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RESIDUE WARNING
Residue Warnings:
Chickens must not be slaughtered for food within 24 hours after treatment. Do not
use in layers producing eggs for human consumption.
Turkeys must not be slaughtered for food within five days after treatment.
Do not use in layers producing eggs for human consumption.
Swine must not be slaughtered for food within 48 hours after treatment.
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. - HOW SUPPLIED
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TYLOVET SOLUBLE
tylosin tartrate powder, for solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:23243-2220 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TYLOSIN TARTRATE (UNII: 5P4625C51T) (TYLOSIN - UNII:YEF4JXN031) TYLOSIN 100 g in 3970 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-2220-1 100 in 1 CASE 1 3790 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200473 01/01/2011 Labeler - Huvepharma, Inc. (619153559)