TETRAVET -CA oxytetracycline hydrochloride powder for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Oxytetracycline hydrochloride (UNII: 4U7K4N52ZM) (Oxytetracycline - UNII:X20I9EN955)
Available from:
Alpharma Inc. Animal Health
INN (International Name):
Oxytetracycline hydrochloride
Composition:
Oxytetracycline 648 g in 1772 g
Prescription type:
OTC TYPE A MEDICATED ARTICLE
Authorization status:
New Animal Drug Application

TETRAVET -CA- oxytetracycline hydrochloride powder, for solution

Alpharma Inc. Animal Health

----------

TETRAVET-CA™

OXYTETRACYCLINE HYDROCHLORIDE

ANTIBIOTIC

This packet contains 648 g of oxytetracycline hydrochloride and will make:

3240 gallons (12,265 liters) containing 200 mg oxytetracycline hydrochloride per gallon

1620 gallons (6,132 liters) containing 400 mg oxytetracycline hydrochloride per gallon

810 gallons (3,066 liters) containing 800 mg oxytetracycline hydrochloride per gallon

This packet will treat 64,800 lbs of swine.

This packet will treat 25,920 lbs of turkey at 25 mg/lbs body weight.

MIXING DIRECTIONS FOR WATER MEDICATION

TURKEYS — SWINE

Dosage and indications for use in water proportioners - Add 1 pack to the following amount of

water to make a stock solution for use in a proportioner set to meter at the rate of one ounce per gallon.

Dis eas e

Treatment Level

Gallons

Stock/Pack

T

U

R

K

E

Y

S

Control of hexamitiasis caused by Hexamita

meleagridis, susceptible to oxytetracycline.

200 - 400 mg

25.3 - 12.6

Control of infectious synovitis caused by

Mycoplasma synoviae, susceptible to oxytetracycline.

400 mg

12.6

GROWING TURKEYS — Control of complicating

bacterial organisms associated with bluecomb

(transmissible enteritis, coronaviral enteritis),

susceptible to oxytetracycline.

25 mg/lb

body weight

Varies with age

& water

consumption

S

W

I

N

E

FOR THE CONTROL AND TREATMENT OF

THE FOLLOWING DISEASES IN SWINE –

Bacterial enteritis caused by Escherichia coli and

Salmonella choleraesuis, susceptible to

oxytetracycline. Bacterial pneumonia caused by

Pasteurella multocida, susceptible to

oxytetracycline.

FOR BREEDING SWINE: Leptospirosis (reducing

the incidence of abortions and shedding of

leptospira) caused by Leptospira pomona,

susceptible to oxytetracycline.

10 mg/lb

body weight

Varies with age

& water

consumption

USE DIRECTIONS

Mix fresh solutions daily. Use as the sole source of drinking water. Do not mix this product directly

with milk or milk replacers. Administer 1 hour before or 2 hours after feeding milk or milk replacers.

Consult a poultry diagnostic laboratory or poultry pathologist for diagnosis and advice on dosage for

turkeys. As a generalization, 100 turkeys will drink 1 gallon of water per day for each week of age.

Administer up to 5 days to swine and 7 to 14 days for turkeys. NOTE: The concentration of drug

required in medicated water must be adequate to compensate for variation in the age of the animal, feed

consumption rate, and the environmental temperatures and humidity, each of which affects water

consumption.

CAUTION

Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or

14 consecutive days in turkeys.

WARNING

Do not feed to birds producing eggs for human consumption.

RECOMMENDED PACKET STORAGE CONDITIONS

Store below 77° F (25° C)

See back panel for instructions.

Net Weight

3.91 lbs (1772 g)

Alpharma Inc.

Bridgewater, New Jersey 08807

For Use in Drinking Water Only

Not For Use in Liquid Medicated Feeds

Keep Out of Reach of Children

NOT FOR HUMAN CONSUMPTION

FOR ANIMAL USE ONLY

HAZARDOUS REMEDY

Restricted Drug (California) - Use

only as directed.

2203BF 0904

NADA #130-435, Approved by FDA

Tetravet-CA is a trademark of Alpharma Inc.

ALPHARMA and the Alpharma Logo

are registered trademarks of Alpharma Inc.

PRINCIPAL DISPLAY PANEL - 1772 g Packet

TETRAVET-CA™

OXYTETRACYCLINE HYDROCHLORIDE

ANTIBIOTIC

This packet contains 648 g of oxytetracycline hydrochloride and will make:

3240 gallons (12,265 liters) containing 200 mg oxytetracycline hydrochloride per gallon

1620 gallons (6,132 liters) containing 400 mg oxytetracycline hydrochloride per gallon

810 gallons (3,066 liters) containing 800 mg oxytetracycline hydrochloride per gallon

This packet will treat 64,800 lbs of swine.

This packet will treat 25,920 lbs of turkey at 25 mg/lbs body weight.

RECOMMENDED PACKET

STORAGE CONDITIONS:

Store below 77° F (25° C)

See back panel for instructions.

Net Weight

3.91 lbs (1772 g)

Alpharma Inc.

Bridgewater, New Jersey 08807

For Use in Drinking Water Only

Not For Use in Liquid Medicated Feeds

Keep Out of Reach of Children

NOT FOR HUMAN CONSUMPTION

FOR ANIMAL USE ONLY

HAZARDOUS REMEDY

Restricted Drug (California) - Use

only as directed.

Take Time

Observe Label

Directions

2203BF 0904

NADA #130-435, Approved by FDA

Tetravet-CA is a trademark of Alpharma Inc.

ALPHARMA and the Alpharma Logo

are registered trademarks of Alpharma Inc.

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

TETRAVET-CA™

(OXYTETRACYCLINE HCl) AN ANTIBIOTIC

FOR USE IN DRINKING WATER ONLY

NOT FOR USE IN LIQUID MEDICATED FEEDS

Each packet contains 648 grams of oxytetracycline HCl

Follow directions for use and mixing instructions on packet label.

RECOMMENDED PACKET STORAGE CONDITIONS: Store below 77° F (25° C)

Keep Out of Reach of Children. NOT FOR HUMAN CONSUMPTION.

FOR ANIMAL USE ONLY. HAZARDOUS REMEDY.

Lot:

Exp:

Contents: 6 packets, 3.91 lbs (1772 grams) each

Alpharma Inc.

Bridgewater, New Jersey 08807

Take Time

Observe Label

Directions

2203CL 0905

Restricted Drug (California) - Use only as directed.

NADA #130-435, Approved by FDA

Tetravet-CA is a trademark of Alpharma Inc.

ALPHARMA & Alpharma Logo are registered trademarks of Alpharma Inc.

TETRAVET -CA

oxytetracycline hydrochloride powder, for solution

Product Information

Product T ype

OTC TYPE A MEDICATED ARTICLE ANIMAL

DRUG

Ite m Code

(S ource )

NDC:46 573-

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O xytetra cycline hydro chlo ride (UNII: 4U7K4N52ZM) (Oxytetracycline - UNII:X20 I9 EN9 55)

O xyte tra c yc line

6 48 g in 1772 g

Product Characteristics

Color

YELLOW

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

Alpharma Inc. Animal Health

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 573-223-46

6 in 1 CONTAINER

1

NDC:46 573-223-78

1772 g in 1 PACKET

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA130 435

0 1/0 1/20 0 9

Labeler -

Alpharma Inc. Animal Health (070954094)

Revised: 5/2009

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