Friday 4 May 2012

Gainpro





Dosage Form: FOR ANIMAL USE ONLY
Gainpro 10

FRONT PANEL


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

MIXING DIRECTIONS AND PERMITTED CLAIMS


Type 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 Feed                     Complete 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 Level    To Be Added Per Ton        Feeding 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


Bag Label Image










Gainpro  10
bambermycins  powder










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)23243-2070
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAMBERMYCINS (BAMBERMYCINS)BAMBERMYCINS22 g  in 1 kg






Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 


















Product Characteristics
Colorbrown ((Off White to Tan))Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
123243-2070-522.68 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14103406/29/2009


Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma AD (552691651)









Establishment
NameAddressID/FEIOperations
Huvepharma, Inc.619153559manufacture, analysis, label, pack
Revised: 03/2010Huvepharma, Inc.



No comments:

Post a Comment