AMPROL 25 TYPE A MEDICATED ARTICLE- amprolium powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)

Available from:

Huvepharma, Inc.

INN (International Name):

AMPROLIUM

Composition:

AMPROLIUM 250 g in 1 kg

Administration route:

ORAL

Prescription type:

OTC TYPE A MEDICATED ARTICLE

Therapeutic indications:

INDICATIONS FOR USE:  AMPROL® 25% (amprolium) Type A medicated article is intended for use in (1) preventing outbreaks of coccidiosis in growing chickens, turkeys, and pheasants and (2) development of active immunity to coccidiosis in replacement chickens. AMPROL 25% is also intended for use in the prevention and treatment of coccidiosis in laying chickens. USER SAFETY WARNING Not for human use. Keep out of reach of children. Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

AMPROL 25 TYPE A MEDICATED ARTICLE- AMPROLIUM POWDER
HUVEPHARMA, INC.
----------
AMPROL 25%
BAG FRONT
APPROVED BY FDA UNDER NADA # 012-350 PRODUCT 956150
AMPROL®25%
(amprolium)
Type A Medicated Article
INDICATIONS FOR USE:
AMPROL® 25% (amprolium) Type A medicated article is intended for use
in (1)
preventing outbreaks of coccidiosis in growing chickens, turkeys, and
pheasants
and (2) development of active immunity to coccidiosis in replacement
chickens.
AMPROL 25% is also intended for use in the prevention and treatment of
coccidiosis in laying chickens.
WITHDRAWAL PERIODS:
No withdrawal period is required when used according to labeling.
ACTIVE DRUG INGREDIENT: Amprolium. . . . . . 25%
INGREDIENTS: Corn Gluten Feed and Soybean Oil
STORAGE: Store at or below 25°C (77°F), excursions permitted to
40°C (104°F).
Avoid prolonged exposure to high humidity.
SEE DIRECTIONS ON BACK PANEL
Manufactured by: Huvepharma, Inc.
Huvepharma, Inc., St. Louis, MO 63116 525 Westpark Drive, Suite 230
Peachtree City, GA 30269
Distributed by:
Huvepharma, Inc., Peachtree City, GA 30269
®AMPROL is a registered trademark of Huvepharma, Inc.
NET WT.: 50 LB (22.68 KG)
MIXING DIRECTIONS
AMPROL® 25% (amprolium) Type A Medicated Article should be thoroughly
and evenly
mixed in the feed. AMPROL 25% may be used
to manufacture a Type C medicated feed in the concentration range of
0.004% to
0.025%. The table below shows the amount of
AMPROL 25% to be used in each ton (2000 lb) of feed to obtain desired
levels of
amprolium in the Type C medicated feed.
To aid in even distribution of AMPROL 25% in the finished feed,
prepare a mixture of
AMPROL 25% in a portion of complete feed
ingredient before mixing into the finished ration. Blend the mixture
with the remainder of
the finished feed and mix thoroughly.
Feeding level of Amprolium
in Type C Medicated Feed
Use This Amount of
AMPROL 25% Per Ton
0.004%
5 oz.
0.006%
8 oz
0.008%
10 oz
0.0125%
1 lb
0.0175%
1 lb 6 ½ oz
0.025%
2 lb
AMOUNT AND DIRECTIONS FOR USE
CHICKENS BROILERS:
Prevention:
Use 0