VETMULIN- tiamulin fumarate concentrate

Vetmulin by

Drug Labeling and Warnings

Vetmulin by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Liquid Concentrate 

WARNINGS

Warning: Keep out of reach of children.
Avoid direct contact with the skin. Direct contact with skin or mucous membranes may cause irritation.

RESIDUE WARNING

Residue Warnings: Withdraw medicated water 3 days before slaughter after treatment at 3.5 mg per pound body weight and 7 days before slaughter after treatment at 10.5 mg per pound body weight.

Active Ingredient: This bottle contains 4.33 oz (125.0 g) tiamulin hydrogen fumarate in
solution.

GENERAL PRECAUTIONS

Caution: For use in drinking water of swine only - Not for use in humans.
Prepare fresh medicated water daily. Use as the only source of drinking
water for 5 days. The effects of tiamulin on swine reproductive performance,
pregnancy and lactation have not been determined.

CONTRAINDICATIONS

Contraindications: Swine being treated with Vetmulin (tiamulin hydrogen
fumarate) should not have access to feeds containing polyether ionophores (e.g.,
monensin, lasalocid, narasin, salinomycin and semduramicin) as adverse reactions
may occur.

INDICATIONS & USAGE

Indications: Treatment of swine dysentery associated with Brachyspira (formerly
Serpulina or Treponema) hyodysenteriae and swine pneumonia due to Actinobacillus
pleuropneumoniae, susceptible to tiamulin.

USER SAFETY WARNINGS

Use Directions: Do not use undiluted. This bottle contains 125,000 mg tiamulin
hydrogen fumarate for use in preparing medicated drinking water for swine.
See package insert for complete directions; read completely.

STORAGE AND HANDLING

Protect from direct sunlight. Store at controlled room temperature, 59°-77°F
(15°-25°C).
Restricted Drug (California): Use only as directed

Distributed by: Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Huvepharma and Vetmulin are registered
trademarks of Huvepharma EOOD

DESCRIPTION

Description: Vetmulin (tiamulin hydrogen fumarate) Liquid Concentrate is a solution
containing 12.5% tiamulin hydrogen fumarate (w/ v) in an aqueous solution.

The active ingredient, tiamulin hydrogen fumarate, chemically is 14-desoxy-14-[(2-diethylaminoethyl)
mercaptoacetoxy] mutilin hydrogen fumarate, a semi-synthetic diterpene antibiotic. Vetmulin
Liquid Concentrate is for use only in preparing medicated drinking water for swine.

MECHANISM OF ACTION

Actions: Tiamulin is active against Brachyspira (formerly Serpulina or Treponema) hyodysenteriae
and Actinobacillus pleuropneumoniae. It is readily absorbed from the gut and can be found in the
blood within 30 minutes after dosing.

VETERINARY INDICATIONS

Indications: Vetmulin (tiamulin hydrogen fumarate), when administered in the drinking
water for five consecutive days, is an effective antibiotic for the treatment of swine dysentery
associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to
tiamulin at a dose level of 3.5 mg tiamulin hydrogen fumarate per pound of body weight
daily and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to
tiamulin when given at 10.5 mg tiamulin hydrogen fumarate per pound of body weight daily.

CONTRAINDICATIONS

Contraindications: Swine being treated with Vetmulin (tiamulin hydrogen fumarate) should not
have access to feeds containing polyether ionophores (e.g., monensin, lasalocid, narasin,
salinomycin and semduramicin) as adverse reactions may occur.

WARNINGS

Warning: Keep out of reach of children. Avoid contact with skin. Direct contact with skin or
mucous membranes may cause irritation.

RESIDUE WARNING

Residue Warnings: Withdraw medicated water 3 days before slaughter after treatment
at 3.5 mg per pound body weight and 7 days before slaughter after treatment at 10.5 mg
per pound body weight.

GENERAL PRECAUTIONS

Caution: For use in drinking water of swine only - Not for use in humans.
Prepare fresh medicated water daily. The effects of tiamulin on swine reproductive performance,
pregnancy and lactation have not been determined.

ADVERSE REACTIONS

Adverse Reactions: Overdoses of 12.5% tiamulin hydrogen fumarate have sometimes produced
transitory salivation, vomiting and an apparent calming effect on the pig. If signs of toxicity occur,
discontinue use of medicated water and replace with clean, fresh water.

In rare cases, redness of the skin primarily over the ham and underline has been observed during
medication. If these signs appear, discontinue use of this drug. Provide ample clean drinking water.
Thoroughly rinse (hose down) the housing to remove urine and feces from animal contact
surfaces or move the animals to clean pens. If the condition persists, consult your veterinarian.

Studies to evaluate the safety of the water soluble form of tiamulin in breeding swine have
not been done.

DOSAGE & ADMINISTRATION

Use Directions: The concentration of tiamulin hydrogen fumarate in the drinking water must be
adjusted to compensate for variation in water consumption due to weight or size of the pig,
environmental temperature and other factors. It is important that pigs receive the proper drug dose,
3.5 mg tiamulin hydrogen fumarate per pound for swine dysentery or 10.5 mg tiamulin hydrogen
fumarate per pound for swine pneumonia, each day for 5 consecutive days.

VETERINARY INDICATIONS

Directions for preparing Vetmulin medicated solutions

Determine the amount of Vetmulin Liquid Concentrate needed to medicate the desired volume of drinking water at the proper concentration.
Carefully measure out this amount, add it to the water and stir to thoroughly mix.

1. Prepare fresh medicated drinking water every day for the 5 day treatment period.
2. Water medicated with Vetmulin should be the only source of drinking water during the treatment period.
*3. Increase or decrease dilution rate as required to obtain proper daily drug dose.
Number of pigs this bottle will treat for ONE day based on water consumption per pig		One Liter
Net tiamulin hydrogen fumarate content:		125,000 mg
Diseases to be treated:		Swine Dysentery	Swine Pneumonia
Daily tiamulin hydrogen fumarate required per pound body weight:		3.5 mg	10.5 mg
Required treatment duration:		5 days	5 days
Pig Wt, lb	Water Intake, gal	# of Pigs	# of Pigs
20	0.3 - 0.5	1,786	595
45	0.4 - 1.1	794	265
75	0.7 - 1.5	476	159
125	1.0 - 2.0	286	95
180	1.2 - 3.0	198	66
Suggested final dilution of:	1 bottle (1 Liter)	550 gal	183 gal
	3 bottles (3 Liters)	1650 gal	550 gal
	1/2 bottle (0.5 Liters)	275 gal	92 gal
Tiamulin hydrogen fumarate concentration per gallon at suggested final dilution*		227 mg	681 mg
		(60 ppm)	(180 ppm)

VETERINARY INDICATIONS

Directions for using Vetmulin

In medicated proportioners: One liter of Vetmulin Liquid Concentrate mixed with water to make 4.3 gallons of stock solution and this stock solution metered at one fluid ounce per gallon will provide 227 mg of tiamulin hydrogen fumarate per gallon to 550 gallons of drinking water for treatment of swine dysentery. Three liters of Vetmulin Liquid Concentrate mixed with water to make 4.3 gallons of stock solution and this stock solution metered at one fluid ounce per gallon will provide 681 mg tiamulin hydrogen fumarate per gallon to a total of 550 gallons of drinking water for treatment of swine pneumonia.

In barrels or tanks: One liter (1000 mL) of Vetmulin Liquid Concentrate will medicate 550 gallons of drinking water at 227 mg per gallon for
treatment of swine dysentery or 183 gallons at 681 mg per gallon for treatment of swine pneumonia.

Measure Vetmulin Liquid Concentrate carefully, pour into the proper amount of water and thoroughly mix. The concentration of tiamulin
hydrogen fumarate in the stock solution and in the drinking water delivered must be adjusted to compensate for variation in water consumption
by pigs due to body weight, environmental and other factors. It is important that the pigs receive the proper drug dose of 3.5 mg of tiamulin
hydrogen fumarate per pound of body weight daily for 5 consecutive days for treatment of swine dysentery or a dose of 10.5 mg per pound
body weight daily for 5 consecutive days for treatment of swine pneumonia.

Attention: If no response to treatment is obtained within 5 days re-establish the diagnosis. Failure of response may be related to the
presence of non-susceptible organisms of other complicating disease conditions. Because of the tendency for the disease to recur on premises
with a history of swine dysentery or with swine pneumonia, a control program should be implemented after treatment. Drugs are not
substitutes for proper sanitary measures or good management, but should be used in conjunction with such practices.

HOW SUPPLIED

How supplied:

Container Size	Active Ingredients
1 Liter bottle	12.5% (125.0 g)
(33.8 fl oz; 1000 mL)	Tiamulin hydrogen fumarate
5 Liter bottle	12.5% (625.0 g)
(169 fl oz; 5000 mL)	Tiamulin hydrogen fumarate
Protect from direct sunlight. Store at controlled room temperature, 59°–77°F (15°–25°C).

Observe expiration date.

ADVERSE REACTIONS

To report suspected adverse drug events, for technical assistance or to obtain a copy of the
Safety Data Sheet, 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.

Principal Display Panel - Vetmulin 1000 mL Bottle Label

Vetmulin® 12.5%

(tiamulin hydrogen fumarate)

Liquid Concentrate

12.5% Tiamulin hydrogen fumarate

Approved by FDA under ANADA # 200-682

One Liter (1.057 Quarts)

(33.8 fl oz; 1000 mL)

Principal Display Panel - Vetmulin 5000 mL Bottle Label

Vetmulin® 12.5%

(tiamulin hydrogen fumarate)

Liquid Concentrate

12.5% Tiamulin hydrogen fumarate

Approved by FDA under ANADA # 200-682

Five Liter (5.285 Quarts)

(169 fl oz; 5000 mL)

5 L Back Label

INGREDIENTS AND APPEARANCE

VETMULIN 
tiamulin fumarate concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 23243-0073
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tiamulin fumarate (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R)	tiamulin fumarate	0.125 g  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-0073-1	1000 mL in 1 BOTTLE
2	NDC: 23243-0073-5	5000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200682	08/20/2020

Labeler - Huvepharma, Inc (619153559)