TYLOVET 100 - tylosin phosphate powder 
Huvepharma, Inc.

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Tylovet 100 Type A  Medicated Article

Tylovet 100

FRONT PANEL

For use in Swine, Beef Cattle and Chicken Feeds Only

Tylovet 100

Tylosin Phosphate

Type A Medicated Article

Do Not Feed Undiluted

Equivalent to 100 g Tylosin per Pound

Swine:

For increased rate of weight gain and improved feed efficiency.

For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis.

For control of swine dysentery associated with Brachyspira hyodysenteriae.

For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with Tylovet Soluble (tylosin tartrate) drinking water.

For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with Tylovet Soluble (tylosin tartrate) in drinking water.

Beef Cattle:

For reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

Chickens:

For increased rate of weight gain and improved feed efficiency.

Laying Chickens

For improved feed efficiency.

Broilers and Replacement Chickens:

To aid in the control of Chronic Respiratory Disease associated with Mycoplasma gallisepticum.

Important: Must be Thoroughly Mixed in Feeds Before Use.

Restricted Drug (California)  Use Only as Directed.

ANADA# 200-484, Approved by FDA

Manufactured By: Biovet AD                                                         Distributed By: Huvepharma, Inc.

39, Petar Rakov Str. 4550 Peshtera                                             525 Westpark Drive, Suite 230

Bulgaria                                                                                         Peachtree, GA 30269

Huvepharma, and Tylovet are trademarks of Huvepharma.

To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

Net weight: 50 lb (22.68 kg)

BACK PANEL LABEL

Directions for Use

Read All Directions Carefully

Before Mixing and Feeding

Tylovet 100 Type A Medicated Article

Net Weight: 50 lbs

(22.68 kg)

Do Not Feed Undiluted

Active Drug Ingredient: Tylosin (as tylosin phosphate)....100 g per lb

Ingredients: Roughage products, pregelatinized starch and dipotassium phosphate.

Important: Must be Thoroughly Mixed in Feeds Before Use.

To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

Warning: Tylovet 100 may be irritating to unprotected skin and eyes. When mixing and handling Tylovet 100 use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

Mixing and Feeding

Directions for Swine Feeds

For increased rate of weight

gain and improved feed efficiency

Feed

Tylovet 100 per Ton

of Type C Feed

Tylosin Per Ton

of Type C Feed

 Pre-Starter or Starter 0.2   to   1.0 lbs 20   to    100 g
 Grower 0.2   to   0.4 lbs 20   to      40 g
 Finisher 0.1   to   0.2 lbs 10   to      20 g
 Feed continuously as the sole ration

For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed. Feed continuously as the sole ration.

For control of swine dysentery. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pound Tylovet 100 per ton) of complete feed until pigs reach market weight.

For the treatment and control of swine dysentery. Feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin tartrate (as Tylovet Soluble) per gallon in drinking water for 3 to 10 days.

For control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin tartrate (as Tylovet Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylovet. Diagnosis should be confirmed by a veterinarian when results are not satisfactory.

NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.

Mixing and Feeding Directions for Beef Cattle Feeds

Tylovet 100 per Ton of Type C Feed

Tylosin Per Ton of Type C

Feed

For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

0.08 to 0.10 lbs

To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.

Feed continuously as the sole ration.

8 to 10 g

Mixing Directions for Liquid Type B

Cattle Feeds

LIMITATIONS:

1.    pH must be between 4.5 and 6.0.

2.    For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

3.    For liquid feeds stored in mechanical, air, or other agitation - type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

 4.    Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture.

 Mixing and Feeding Directions for Chicken Feeds Tylovet 100 Per Ton of Type C FeedTylosin Per Ton of Type C Feed 
 For increased rate of weight gain and improved feed efficiency.

0.04 to 0.5 lbs 

Feed continuously as the sole ration

 4 to 50 g

Mixing and Feeding Directions for

Broiler and Replacement Chicken

Feeds

Tylovet 100 Per Ton of

Type C Feed

Tylosin Per Ton of Type C Feed

 To aid in the control of chronic respiratory

disease associated with Mycoplasma gallisepticum.

Broilers

Replacement Chickens

8 to 10 lbs

10 lbs 

 800 to 1000 g

1000 g

For Broiler and Replacement Chickens: Administer in the feed to chickens 0 to 5 days of age, follow with second administration in feed for 24 to 48 hours at 3 to 5 weeks of age.

NOT FOR HUMAN USE

 WARNING: Withdraw 5 days before slaughter when fed to chickens at 800 to 1000 grams per ton.

Mixing and Feeding Directions for Laying

Chicken Feeds

Tylovet 100 Per Ton of Type C FeedTylosin Per Ton of Type C Feed
 For improved feed efficiency.Laying Chickens 0.2 to 0.5 lbs  20 to 50 g

image description

Store at Room Temperature, 25°C (77°F).

Avoid moisture.

Not to be used after the date printed on the bottom of the bag.

Principal Display Panel

Bag Label

TYLOVET 100  
tylosin phosphate powder
Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABELItem Code (Source)NDC:23243-2350
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TYLOSIN PHOSPHATE (TYLOSIN) TYLOSIN100 g  in 0.45 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23243-2350-122.68 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20048403/01/2012
Labeler - Huvepharma, Inc. (619153559)
Registrant - Huvepharma, AD (552691651)
Establishment
NameAddressID/FEIBusiness Operations
Biovet-AD645015512medicated animal feed manufacture, manufacture, analysis, pack, label, api manufacture

Revised: 8/2013
Document Id: 464cf998-a9b6-4600-8aab-9948e72da97e
Set id: dac46d7b-d852-42ca-822b-32ba0faf5038
Version: 3
Effective Time: 20130821
 
Huvepharma, Inc.