BimaGard 12.5%: Product Information

BIMAGARD 12.5%- tiamulin fumarate liquid
Bimeda, Inc.

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:
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:
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.

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

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:
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.

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.

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 Dysenter y

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.

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 conjunctionwith such practices.

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 uprightposition. Store at 20°C — 25°C (68°F — 77°F), excursions

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

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BIMAGARD 12.5% tiamulin fumarate liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-4003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAMULIN FUMARATE (TIAMULIN) TIAMULIN 0.125 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61133-4003-1 1000 mL in 1 BOTTLE None
2 NDC:61133-4003-2 5000 mL in 1 BOTTLE None
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 Operations
Bimeda, Inc. 060492923 manufacture
Establishment
Name Address ID/FEI Operations
SEL Biochem Xinjiang Co., Ltd 421318752 api manufacture

Revised: 12/2020 Bimeda, Inc.

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