GAINPRO 10- bambermycins powder

Gainpro by

Drug Labeling and Warnings

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

Drug Details [pdf]

MIXING DIRECTIONS AND PERMITTED CLAIMS

Gainpro®

BambermycinsType A Medicated Article

PERMITTED CLAIMS AND LIMITATIONS

Species                 Drug                 Level                 Claim(s)                 Limitations

Cattle Fed in          Bambermycins 10 to 20               Increased rate        None
Confinement for                             mg/hd/day**        of weight gain,
Slaughter*                                                               improved feed
                                                                              efficiency
Pasture                Bambermycins   10 to 40              Increased rate        None
Cattle*                                           mg/hd/day***      of weight gain

*Only a single level of bambermycins (i.e. 2 grams bambermycins/ton) can be
indicated on a feed tag. A different feed tag must be submitted for each level of
bambermycins needed for your complete feeding program.

CATTLE FED IN CONFINEMENT FOR SLAUGHTER:
**THE APPROVED DOSAGE IN CATTLE FED IN CONFINEMENT FOR SLAUGHTER IS 10
TO 20 MG OF BAMBERMYCINS/HD/DAY. The amount of bambermycins will range between
1 and 4 grams per ton of feed depending upon the daily feed consumption of the cattle fed in
confinement for slaughter. The amount of Type A Medicated Article added to the complete
ration (Type C Medicated Feed) must be based on daily feed consumption, the number of
animals in the pen and the level (10-20 mg/hd/day) of bambermycins being fed. From this
information the grams of bambermycins per ton of feed can be calculated in order to fulfill
feed assay requirements. No Type C Medicated Feed should be manufactured with less than
1 g bambermycins/ton. Feed assays for bambermycins with expected levels below 1 g/t may
not be accurate. See the following table for conversions from mg/hd/day to g/t.

EXAMPLE OF CONVERTING THE BAMBERMYCINS CATTLE DOSAGE FROM
                        MG/HEAD/DAY TO GRAMS/TON*

            Mg
                   Average Feed            Grams                Bambermycinx
Cattle         Consumption/         Bambermycins/         Fed Daily to
Weight         Head/Day             Ton of Feed               each Animal
Lbs.     Kg         Lbs.1                Low         High         Low             High
400     181.4     10.0                 2.00         4.00         10.0             20.0
500     226.8     14.0                 1.50         2.80         10.5             19.6
600     272.2     17.0                 1.25         2.30         10.6             19.6
700     317.5     20.0                 1.00         2.00         10.0             20.0
800     362.9     22.0                 1.00         1.80         11.0             19.8
900     408.2     23.0                 1.00         1.70         11.5             19.6
1000   453.6     24.0                 1.00         1.60         12.0             19.2
1100   499.0     25.0                 1.00         1.60         12.5             20.0
1200   544.3     26.0                 1.00         1.50         13.0             19.5
1300   589.7     27.0                 1.00         1.40         13.5             18.9
*Dosage range is 10 to 20 mg/head/day             1Assumes as fed ad libitum
consumption and average daily gain
of 2.0 to 3.0 lbs./day

Example Calculation—Amount of GAINPRO®-10 premix added to feed for a pen of cattle.
Given: Average Weight—800 lbs.; Number in pen—100 hd.; Dosage—20 mg/hd/day; Daily
Feed Consumption—22 lbs./day.
100 hd x 20 mg = 2,000 mg or 2 grams bambermycins.
GAINPRO®-10 contains 10 grams bambermycins/lb., therefore add 0.2 pound of
GAINPRO®-10 premix to the daily feed for this pen of 100 animals.
22 lbs./day x 100 hd = 2,200 lbs. total feed consumption.
2 grams bambermycins ÷ 2,200 lbs. = .000909 g/lb.
.000909 x 2,000 lbs. = 1.82 g bambermycins/ton of feed.

MIXING DIRECTIONS:
It is recommended that GAINPRO®-10 be diluted with a suitable grain carrier before addition
to the final feed. A dilution of 1 part of GAINPRO®-10 and 9 parts grain carrier is the
suggested working premix. The table below shows premix and working premix addition levels
for various commonly used feeds.

        Pounds Premix To Be Added Per Ton
Feed             Bambermycins Level         GAINPRO®-1   1-9 Working Premix
Cattle Fed in         1 gram/ton                                0.1                                1
Confinement         2 grams/ton                              0.2                                 2
for Slaughter         3 grams/ton                              0.3                                 3
                            4 grams/ton                              0.4                                 4

Thoroughly mix both working premix and finished feed to ensure complete and uniform
distribution of the GAINPRO®-10.

FEEDING DIRECTIONS:
Feeds containing GAINPRO®-10 should be fed continuously in a complete feed. Complete
feed for cattle fed in confinement for slaughter must be fed continuously at a rate of 10-20 mg
bambermycins/hd/day from Type C Medicated Feed containing 1-4 g bambermycins/ton.

TYPE B LIQUID FEEDS INTENDED FOR ADDITION TO DRY FEEDS FOR
CONFINEMENT CATTLE
Type B Liquid Feeds should be in a pH range of 3.8 to 7.5 and should have a moisture
content between 30 and 45%.
Type B Liquid Feeds must be mixed into the dry feed within 8 weeks of manufacture.
Type B Liquid Feeds can be manufactured containing 40.0 to 800.0 g of bambermycins/ton.
Mixing directions into dry feed are as follows:

Before feeding, the Type B Medicated Liquid feed must be thoroughly mixed with other feed
materials to make a complete feed (Type C Medicated Feed). Examples of addition rates to
complete feeds are shown in the following table.

    Addition Rate of Type B     Bambermycins (g/ton) in
Bambermycins (g/ton) in         Liquid Feed (pounds/ton) to     Final Complete Feed
Type B Liquid FeedComplete Feed                     (Type C Medicated Feed)
40.0                                                         50.0                                          1.0
40.0                                                         200.0                                         4.0

100.0                                                        20.0                                          1.0
100.0                                                        80.0                                           4.0

400.0                                                         5.0                                           1.0
400.0                                                       20.0                                           4.0

800.0                                                         2.5                                           1.0
800.0                                                       10.0                                           4.0
The complete dry feed (Type C Medicated Feed) may only be fed to cattle in confinement for
slaughter and must be fed within one week after mixing.

PASTURE CATTLE:
***THE APPROVED DOSAGE IN PASTURE CATTLE IS 10 TO 40 MG OF BAMBERMYCINS/
HD/DAY. Daily intakes of bambermycins in excess of 20 mg/head/day have not
been shown to be more effective than 20mg/head/day. Blend 0.8 pound of GAINPRO®-10
with 1999.2 pounds of suitable grain carrier. This supplemental feed will contain 4 mg bambermycins
per pound (8 g/ton). This supplemental feed can be fed at a rate of 2.5 to 10
pounds per head per day to achieve a daily intake of 10 to 40 mg bambermycins/head/day.
See the following table for additional examples of conversion from mg/hd/day to g/t.

MIXING DIRECTIONS:
It is recommended that GAINPRO®-10 be diluted with a suitable grain carrier to provide a
supplemental feed. The table below shows examples of premix addition levels.

Pounds
GAINPRO®-10
Feed Bambermycins LevelTo Be Added Per TonFeeding Rate
Pasture             2 grams/ton                         0.2                         10.0 lb./hd/day
Cattle                4 grams/ton                         0.4                         5.0-10.0 lb./hd/day
                        8 grams/ton                         0.8                         2.5-10.0 lb./hd/day
                       20 grams/ton                        2.0                         1.0-4.0 lb./hd/day
                       40 grams/ton                        4.0                         1.0-2.0 lb./hd/day
                       80 grams/ton                        8.0                         1.0 lb./hd/day

Thoroughly mix both working premix and supplemental feed to ensure complete and uniform
distribution of the GAINPRO®-10.

FEEDING DIRECTIONS:
Feed for Pasture Cattle must be fed continuously at a rate of 10-40 mg bambermycins/hd/day
in at least one pound and not more than 10 pounds of Type C Medicated Feed containing 2-
40 g bambermycins/ton. Daily intakes of bambermycins in excess of 20 mg/head/day have
not been shown to be more effective than 20 mg/head/day.

FREE-CHOICE (SELF-FED) SUPPLEMENT:
Free-choice supplements must be formulated to provide not less than 10 mg nor more than
40 mg bambermycins per head per day. An FDA approved formula must be used to manufacture
free-choice medicated feeds containing bambermycins. Feed mills that use a proprietary formula
are required to be licensed.

Bag Label Image

GAINPRO®10

For increased rate of weight gain and
improved feed efficiency in cattle fed in
confinement for slaughter. For increased rate
of weight gain in pasture cattle (slaughter,
stocker and feeder cattle, and dairy and beef
replacement heifers).

ACTIVE INGREDIENTS
Bambermycins 10 grams per pound (22
grams per kilogram)

INGREDIENTS
Roughage products and/or calcium carbonate,
dried bambermycins fermentation product,
mineral oil.

MIXING DIRECTIONS AND PERMITTED
CLAIMS ON REVERSE SIDE.
FOR USE IN MANUFACTURED FEEDS ONLY.
NOT FOR HUMAN USE
Restricted Drug (California)-
use only as directed

Net Weight—50 pounds (22.68 kg)

Distributed by:
HUVEPHARMA, INC.
Peachtree City, GA 30269
NADA # 141-034, Approved by FDA

INGREDIENTS AND APPEARANCE

GAINPRO  10
bambermycins powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 23243-2070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BAMBERMYCINS (UNII: PP922A42V2) (BAMBERMYCINS - UNII:PP922A42V2)	BAMBERMYCINS	22 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ETHOXYQUIN (UNII: 9T1410R4OR)

Product Characteristics
Color	brown ((Off White to Tan))	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-2070-5	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141034	08/22/2016

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc.		883128204	manufacture, analysis, label, pack, medicated animal feed manufacture