BIMAGARD 12.5%- tiamulin fumarate liquid

BimaGard 12.5% by

Drug Labeling and Warnings

BimaGard 12.5% by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., SEL Biochem Xinjiang Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Description:
BimaGard™ 12.5% (tiamulin hydrogen fumarate) 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. BimaGard™ 12.5% is for use only in
preparing medicated drinking water for swine.

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.

INDICATIONS & USAGE

Indications:
BimaGard™ 12.5% (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 BimaGard™ 12.5% (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.

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.

ADVERSE REACTIONS

Adverse Reactions:
Overdoses of 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.

To report suspected adverse drug events, for technical
assistance or to obtain a copy of the Safety Data Sheet (SDS),
contact Bimeda, Inc. at 1-888-524-6332. For additional
information about adverse drug experience reporting for
animal drugs, contact FDA at 1-888-FDA-VETS or online at
www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Directions for preparing BimaGard™ 12.5% medicated solutions

Determine the amount of BimaGard™ 12.5% (tiamulin hydrogen

fumarate) 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.

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	227 mg	681 mg
concentration per gallon  at	(60 ppm)	(180  ppm)
suggested final dilution*

1. 
   Prepare fresh medicated drinking water every day for the 5

day treatment period.

2.    Water medicated with Bimagard 12.5% 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.

SPL UNCLASSIFIED SECTION

Directions for using BimaGard™ 12.5%
In medicated proportioners: One liter of BimaGard™
12.5% (tiamulin hydrogen fumarate) 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 BimaGard™ 12.5% 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 BimaGard™
12.5% 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 BimaGard™ 12.5% 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 Ingredient
• 1 Liter bottle(33.8 fl oz; 1000 mL): 12.5% (125.0 g); Tiamulin hydrogen fumarate
• 5 Liter bottle(169 fl oz; 5000 mL): 12.5% (625.0 g); Tiamulin hydrogen fumarate

Protect from direct sunlight. Store container in an upright
position. Store at 20°C - 25°C (68°F - 77°F), excursions

permitted between 15°C - 30°C (59°F - 86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIMAGARD 12.5% 
tiamulin fumarate liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-4003
Route of Administration	ORAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-4003-1	1000 mL in 1 BOTTLE
2	NDC: 61133-4003-2	5000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200546	01/21/2020

Labeler - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu SEL Biochem Co., LTD		546002346	api manufacture