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Tylovet

Huvepharma, Inc.

TYLOVET SOLUBLE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 chronic respiratory disease (CRD) associated with Mycoplasma
gallisepticum
sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease
(CRD) associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.
Turkeys: For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma
gallisepticum
sensitive to tylosin.
Swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.
Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).


INGREDIENTS

Tylosin (as tylosin tartrate) …………………………………………. 100 g

MIXING DIRECTIONS

Chickens and Turkeys: To assure thorough dissolution, place the Tylovet (contents of the jar or pouch) in a mixing container and
add one gallon of water (3790 mL) to the material. Mix this concentrated solution with water to make 50 gallons (189 liters) of
treated drinking water.
Swine: To assure thorough dissolution, place the Tylovet (contents of the jar or pouch) in a mixing container and add one gallon
of water (3790 mL) to the material. Mix this concentrated solution with water to make 400 gallons of treated drinking water
resulting in 250 mg/gallon.
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 Tylovet solution every three days.
When mixing and handling tylosin, use protective clothing and impervious gloves.

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 should be treated for three to ten days, depending upon severity of infection. Treated swine must consume enough
medicated water to provide a therapeutic dose. Only medicated water (250 mg/gal) should be available.
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.
Notice: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after
recommended treatment, diagnosis and susceptibility should be reconfirmed.

RESIDUE WARNING: 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.

SAFETY INFORMATION

NOT FOR HUMAN USE


Avoid contact with human skin. Exposure to tylosin may cause a rash.


To report adverse effects, access medical information, or obtain additional product information, call 1-877-426

How supplied:
Tylovet® Soluble is supplied in pouches of laminated aluminum foil, 100 g of tylosin activity
per pouch; or HDPE jars with PP cap with heat sealable coating, 100 g of tylosin activity per jar.

STORAGE

Storage:
Store at Room Temperature, 25°C (77°F).
(Excursions Permitted to 40°C/104°F). Avoid moisture.

TOP AND BOTTOM LABEL TEXT

Tylovet Soluble
(tylosin tartrate)

For use In chickens, turkeys, swine and honey bees only
Equivalent to 100 g tylosin base

An Antibiotic
ANADA# 200-473, Approved by FDA

Manufactured for: Huvepharma Inc. Peachtree City, GA 30269 , Made in Bulgaria

Lot: 00000000000 Exp. Date: 00.0000

POUCH LABEL IMAGE

POUCH LABEL IMAGE

Tylovet

Tylovet

Tylosin tartrate POWDER, FOR SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:23243-2220
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
tylosin tartrate tylosin 100 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23243-2220-1 3790 in 1 POUCH
2 NDC:23243-2220-2 3790 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200473 2011-01-01


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