BOVATEC- lasalocid sodium granule

Bovatec by

Drug Labeling and Warnings

Bovatec by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Lasalocid
Type A Medicated Article

Net wt 50 LB (22.68 kg)

Active ingredient

Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity) in a carrier suitable for incorporation in feed.

Important

Handling Information - Must be thoroughly mixed in feeds before use. When mixing and handling lasalocid Type A medicated articles, use protective clothing, impervious gloves and a dust mask. Avoid contact with eyes. Operators should wash hands thoroughly with soap and water after handling.

Mixing directions

This product should be further diluted in an intermediate blending step prior to mixing in the final feed. Do not feed undiluted.

1. Complete Feed

               a.      Intermediate blending: Mix 1 part of Bovatec 91 (Type A Medicated Article) with 17 parts of finely ground non-medicated                         feedstuffs to provide an intermediate premix containing 5 grams of lasalocid per pound.

                b.     Using the 5 g/lb intermediate preblend, the following table would apply to the manufacture of complete feeds:      

Intended lasalocid concentration in the complete feed		Add the following amounts of 5 grams per pound intermediate premix per ton of complete feed mixed:
grams/ton	mg/lb	lbs/ton
* Maximum approved concentration for complete feeds for feedlot cattle and sheep in confinement
10	5	2
15	7.5	3
30*	15	6

              c.     Using the 5 g/lb intermediate premix, the following table would apply to the manufacture of other complete feeds and                                 supplements that do not require further mixing:

Daily feeding rate	Desired daily lasalocid intake	Add the following amounts of 5 grams per pound intermediate premix per ton of feed or supplement mixed:	Lasalocid will be present in the feed or supplement at the following concentration:
lbs/head/day	mg/head/day	lbs/ton	grams/ton
1	60	24	120
	200	80	400
	300	120	600
2	60	12	60
	200	40	200
	300	60	300
3	60	8	40
	200	26.7	133.5
	300	40	200

2. Dry Supplement

                 a.      Intermediate blending: Mix 1 part Bovatec 91 preblend(Type A Medicated Article) with 3.5 parts of finely ground non-                          medicated feedstuffs to provide an intermediate preblend containing 20 grams of lasalocid per pound. For example, mix                           one 50 lb bag of Bovatec 91 preblend with 175 lbs of non-medicated feedstuffs.

                 b.     Using the 20 g/lb intermediate preblend, the following table would apply to the manufacture of dry supplements:       

Intended lasalocid concentration in the supplement		Add the following amounts of 20 grams per pound intermediate premix per ton of supplement mixed:
grams/ton	mg/lb	lbs/ton
400	200	20
600	300	30
1000	500	50
1440	720	72
1600	800	80

              c.     Thoroughly mix supplement with sufficient non-medicated feedstuffs in accordance with the feeding rates listed in the use                         directions below.

3. Liquid Supplement Intended for Addition to Dry Feeds

              a.     Supplements with suspending agent(s) should be in a pH range of 4-8 and maintain physical stability for up to three months                       with a viscosity not less than 300 cps.

              b.     Conventional liquid supplements should be in a pH range of 4-8.                                                                                                                    For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no 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.                                                                                                                                                            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.

Use directions

Species	Dose	Indications for use
Feedlot Cattle	10-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency in cattle being fed in confinement for slaughter, feed continuously to provide not less than 100 mg nor more than 360 mg per head per day.
	25-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency and increased rate of weight gain in cattle being fed in confinement for slaughter, feed continuously to provide not less than 250 mg nor more than 360 mg per head per day.
Pasture Cattle – slaughter, stocker, feeder cattle, and dairy and beef replacement heifers	60-300 mg lasalocid per head/day	For increased rate of weight gain. The drug must be contained in at least 1 pound of feed and fed continuously on a daily basis.
	60-300 mg lasalocid per head/day	For increased rate of weight gain, feed continuously on a free-choice basis. A medicated feed mill license is required when free-choice feed is manufactured using a proprietary formula and/or specifications. Free-choice  feed formulations must be FDA-approved.
		Daily lasalocid intakes in excess of 200 mg per head per day have not been shown to be more effective than 200 mg lasalocid per head per day.
		NOTE: Coccidiosis may occur when young pasture cattle are co-mingled with adult cattle passing coccidial oocysts.
Cattle	1 mg lasalocid per 2.2 lbs body weight/day	For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs. Hand feed continuously to provide not more than 360 mg per day.
Sheep	20-30 grams lasalocid per ton of total ration (90% dry matter)	For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata in sheep maintained in confinement. Feed continuously to provide not less than 15 mg nor more than 70 mg per head per day depending on body weight.
Rabbits	113 grams lasalocid per ton of total ration	For prevention of coccidiosis caused by Eimeria stiedae. Feed as the sole ration for up to 6½ weeks of age.

Caution

Animal Safety - Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

Warning

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

SPL UNCLASSIFIED SECTION

Store below 25°C (77°F), excursions permitted to 37°C (99°F).

Restricted drug (California) - Use only as directed. Not for human use.

NADA 96-298, Approved by FDA.

SPL UNCLASSIFIED SECTION

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

Net wt 50 LB (22.68 kg)

Made in USA

40015347

PRINCIPAL DISPLAY PANEL - 50 LB label

Bovatec®
91

Lasalocid

Type A Medicated Article

Net wt 50 LB (22.68 kg)

Bovatec®
91

  

 

 

INGREDIENTS AND APPEARANCE

BOVATEC 
lasalocid sodium granule

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 54771-1461
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LASALOCID SODIUM (UNII: W2S5C71Y3G) (LASALOCID - UNII:W7V2ZZ2FWB)	LASALOCID	90.7 g  in 0.45 kg

Product Characteristics
Color	BROWN (light Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-1461-1	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA096298	01/01/2009

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
Zoetis LLC		069370112	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Zoetis LLC		004341491	API MANUFACTURE