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Albon

Pfizer Animal Health
Pfizer Inc.

ALBON (sulfadimethoxine)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Boluses

ALBON DESCRIPTION

Albon is a low-dose, rapidly absorbed, longacting sulfonamide.

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Sulfadimethoxine has been demonstrated in laboratory studies to be effective against a wide variety of organisms, such as streptococci, staphylococci, and members of the E. coli-salmonella group of bacteria.

Comparatively low doses of Albon give rapid, sustained blood levels required for effective disease therapy.

ALBON INDICATIONS AND USAGE

Albon is effective in the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine in cattle.

WARNINGS

Not for Human Use

Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food.

Do not slaughter animals for food purposes within 7 days following the last treatment.

A withdrawal period has not been established for this product in preruminating calves.

Do Not Use in Calves to be Processed for Veal

Albon

PRECAUTIONS

During treatment period, make certain that animals maintain adequate water intake.

If animals show no improvement within 2–3 days, reevaluate your diagnosis. Treatment should not be continued beyond 5 days.

ALBON DOSAGE AND ADMINISTRATION

Albon should be administered to cattle so that the initial dose is equivalent to 25 mg/lb of body weight and each subsequent daily dose is equivalent to 12.5 mg/lb of body weight. Length of treatment will depend on clinical response. In most cases, treatment for 3–4 days is adequate. Treatment should not be continued beyond 5 days.

The following tables show the dosage and dosage forms to be used for cattle of different weights.

Albon Boluses, 5 g
Dosage Schedule for Cattle: 200–600 lb of body weight
Animal Weight, lb First Day Daily for the Following 3–4 Days
200 1 bolus 1/2 bolus
300 1 1/2 boluses 1 bolus
400 2 boluses 1 bolus
500 2 1/2 boluses 1 1/2 boluses
600 3 boluses 1 1/2 boluses
Albon Boluses, 15 g
Dosage Schedule for Cattle: 600–1,200 lb of body weight
Animal Weight, lb First Day Daily for the Following 3–4 Days
600 1 bolus 1/2 bolus
800 1 1/2 boluses 1 bolus
1,000–1,200 2 boluses 1 bolus

TOXICITY AND SAFETY

Albon has been shown to be a well-tolerated sulfonamide with relatively high solubility at the pH normally occurring in the kidney and with a low degree of toxicity. Following the administration of Albon at the recommended dosage, no undesirable side effects have been observed.

Store at Controlled Room Temperature 15°–30°C (59°–86°F)

HOW SUPPLIED

Albon Boluses are supplied in the following dosage forms:

5 g sulfadimethoxine per single-scored bolus
15 g sulfadimethoxine per single-scored bolus

Restricted Drug (California)—Use Only as Directed

NADA #31-715, Approved by FDA

Distributed by:
Pfizer Animal Health
Div. of Pfizer INc
Ny, NY 10017

11675900
Revised: January 2011

PRINCIPAL DISPLAY PANEL - 5 g Bottle Label

ALBON ®
(sulfadimethoxine)

Each bolus contains 5 g sulfadimethoxine.

Not for Human Use

For the treatment of shipping
fever complex and bacterial
pneumonia associated with
Pasteurella spp. sensitive to sulfadimethoxine;
and calf diphtheria and foot rot associated with
Fusobacterium necrophorum sensitive to
sulfadimethoxine in cattle.

Bolus
5 g

50 boluses

NADA #31-715, Approved by FDA

Pfizer

Albon

PRINCIPAL DISPLAY PANEL - 15 g Bottle Label

ALBON ®
(sulfadimethoxine)

Each bolus contains 15 g sulfadimethoxine.

Not for Human Use

For the treatment of shipping fever complex and bacterial
pneumonia associated with organisms such as Pasteurella spp.
sensitive to sulfadimethoxine; and calf diphtheria and foot rot
associated with Fusobacterium necrophorum sensitive to
sulfadimethoxine in cattle.

Bolus
15 g

50 boluses

NADA #31-715, Approved by FDA

Pfizer

Albon

Albon

sulfadimethoxine TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:61106-8448
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
sulfadimethoxine Sulfadimethoxine 5 g

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off White) 35 mm Albon;5 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8448-1 50 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA031715 1968-04-12


Albon

sulfadimethoxine TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:61106-8449
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
sulfadimethoxine Sulfadimethoxine 15 g

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off White) 53 mm Albon;15 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8449-2 12 in 1 BOTTLE, PLASTIC
2 NDC:61106-8449-1 50 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA031715 1968-04-12


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Be sure to consult your doctor before taking any medication!
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