AGRIMYCIN 200- oxytetracycline injection

AGRIMYCIN by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

                                    AGRIMYCIN® 200
                             (oxytetracycline injection)

                                           Antibiotic

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate.

For the treatment of disease in beef cattle; dairy cattle; calves, including preruminating
(veal) calves; and swine 

                                 For animal use only 
                     Approved by FDA under ANADA # 200-128

DESCRIPTION

AGRIMYCIN® 200 (oxytetracycline injection) is a sterile, preconstituted
solution of the broad-spectrum antibiotic oxytetracycline. Each mL
contains 200 mg of oxytetracycline base as oxytetracycline dihydrate,
and on a w/v basis, 40.0% 2-pyrrolidone, 5.0% povidone, 1.8%
magnesium oxide, 0.2% sodium formaldehyde sulfoxylate (as a
preservative), monoethanolamine and/or hydrochloric acid as
required to adjust pH.

WARNINGS AND PRECAUTIONS

CAUTION: When administered to cattle, muscle discoloration may
necessitate trimming of the injection site(s) and surrounding tissues
during the dressing procedure.

Warnings: Discontinue treatment at least 28 days prior
to slaughter of cattle and swine. Milk taken from animals
during treatment and for 96 hours after the last treatment
must not be used for food.

Precautions: Exceeding the highest recommended level of drug per lb
of body weight per day, administering more than the recommended
number of treatments, and/or exceeding 10 mL subcutaneously per
injection site in adult beef and dairy cattle, and 5 mL intramuscularly
per injection site in adult swine, may result in antibiotic residues
beyond the withdrawal period.

SPL UNCLASSIFIED SECTION

® Registered Trademark of Huvepharma, Inc.
Manufactured for Huvepharma, Inc., Peachtree City, GA 30269

LOT NO.:                                              EXP. DATE:

DOSAGE & ADMINISTRATION

Dosage: Cattle: A single dosage of 9 mg of oxytetracycline per lb
of body weight (4.5 mL/100 lb) administered subcutaneously is
recommended in the treatment of the following conditions:
1) bacterial pneumonia caused by Pasteurella spp. (shipping fever)
in calves and yearlings, where retreatment is impractical due to
husbandry conditions, such as cattle on range, or where repeated
restraint is inadvisable; 2) infectious bovine keratoconjunctivitis
(pinkeye) caused by Moraxella bovis.

Swine: A single dosage of 9 mg of oxytetracycline per lb of body
weight (4.5 mL/100 lb) administered intramuscularly is recommended
in the treatment of bacterial pneumonia caused by Pasteurella
multocida in swine, where retreatment is impractical due to husbandry
conditions or where repeated restraint is inadvisable.

Refer to Package Onsert for Complete Directions.

HOW SUPPLIED

How Supplied: AGRIMYCIN® 200 is available in 100 mL, 250 mL and
500 mL multi-dose amber vials.

STORAGE AND HANDLING

Storage: Store at room temperature 15°-25°C
(59°-77°F). Keep from freezing. Use within 12
months of first puncture. Puncture a maximum
of 100 times.

Not For Human Use

SPL UNCLASSIFIED SECTION

                              AGRIMYCIN® 200
                        (oxytetracycline injection)

                                     Antibiotic

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Each mL contains 200 mg of oxytetracycline base as oxytetracycline dihydrate.

For the treatment of diseases in beef cattle; dairy cattle; calves, including
preruminating (veal) calves; and swine

                                For animal use only

               Read Entire Package Onsert Carefully Before
                                 Using This Product.

DESCRIPTION

AGRIMYCIN® 200 (oxytetracycline injection) is a sterile,
ready-to-use solution for the administration of the
broad-spectrum antibiotic oxytetracycline by injection.

AGRIMYCIN® 200 administered to cattle or swine for the
treatment of bacterial pneumonia at a dosage of 9 mg of
oxytetracycline per lb of body weight has been demonstrated
in clinical trials to be as effective as 2 or 3 repeated, daily
treatments of oxytetracycline injectable at 3-5 mg/lb of body
weight.

AGRIMYCIN® 200 does not require refrigeration; however, it is
recommended that it be stored at room temperature, 15º-25ºC
(59º-77ºF). The antibiotic activity of oxytetracycline is not
appreciably diminished in the presence of body fluids, serum,
or exudates.

WARNINGS AND PRECAUTIONS

CAUTION: When administered to cattle, muscle discoloration may necessitate trimming of the
injection site(s) and surrounding tissues during the dressing procedure.

WARNINGS: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Milk
taken from animals during treatment and for 96 hours after the last treatment must not be used
for food. Rapid intravenous administration may result in animal collapse.

Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes.

PRECAUTIONS: Exceeding the highest recommended dosage level of drug per lb of body weight per
day, administering more than the recommended number of treatments, and/or exceeding 10 mL
subcutaneously per injection site in adult beef and dairy cattle, and 5 mL intramuscularly per
injection site in adult swine, may result in antibiotic residues beyond the withdrawal period.

At the first sign of any adverse reaction, discontinue use of the product and seek the advice of
your veterinarian. Some of the reactions may be attributed either to anaphylaxis (an allergic
reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection, treated animals may have transient hemoglobinuria resulting in darkened
urine.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible
organisms, including fungi. A lack of response by the treated animal, or the development of new
signs, may suggest that an overgrowth of nonsusceptible organisms has occurred. If any of these
conditions occur, consult your veterinarian.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable
to avoid giving AGRIMYCIN® 200 in conjunction with penicillin.

ADVERSE REACTIONS

ADVERSE REACTIONS: Reports of adverse reactions associated with oxytetracycline administration include 
injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or 
scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse 
and possibly death. Some of these reactions may be attributed to anaphylaxis (an allergic reaction) or to 
cardiovascular collapse of unknown cause.

STORAGE AND HANDLING

STORAGE: Store at room temperature 15°-25°C (59°-77°F).
Keep from freezing. Use within 12 months of first puncture.
Puncture a maximum of 100 times.

INFORMATION FOR OWNERS/CAREGIVERS

CARE OF SICK ANIMALS: The use of antibiotics in the management of diseases is based on
an accurate diagnosis and an adequate course of treatment. When properly used in the
treatment of diseases caused by oxytetracycline susceptible organisms, most animals
that have been treated with AGRIMYCIN® 200 show a noticeable improvement within 24-48
hours.

INDICATIONS & USAGE

INDICATIONS: AGRIMYCIN® 200 is intended for use in the treatment of the following
diseases in beef cattle; dairy cattle; calves, including preruminating (veal)
calves; and swine when due to oxytetracycline-susceptible organisms:

Cattle: AGRIMYCIN® 200 is indicated in the treatment of pneumonia and shipping
fever complex associated with Pasteurella spp. and Haemophilus spp; infectious
bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and
diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours)
caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii;
leptospirosis caused by Leptospira pomona; and wound infections and acute metritis
caused by strains of staphylococci and streptococci organisms sensitive to
oxytetracycline.

Swine: AGRIMYCIN® 200 is indicated in the treatment of bacterial enteritis (scours,
colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida;
and leptospirosis caused by Leptospira pomona.

In sows, AGRIMYCIN® 200 is indicated as an aid in the control of infectious enteritis
(baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

DOSAGE & ADMINISTRATION

DOSAGE:

Cattle: AGRIMYCIN® 200 is to be administered by subcutaneous (SC, under
the skin) or intravenous injection according to Beef Quality Assurance
Guidelines.

A single dosage of 9 mg of AGRIMYCIN® 200 per lb of body weight administered
subcutaneously is recommended in the treatment of the following conditions:
1) bacterial pneumonia caused by Pasteurella spp. (shipping fever) in calves
and yearlings, where retreatment is impractical due to husbandry conditions,
such as cattle on range, or where their repeated restraint is inadvisable;
2) infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

AGRIMYCIN® 200 can also be administered by subcutaneous or intravenous injection
at a level of 3-5 mg of oxytetracycline per lb of body weight per day. In the
treatment of severe foot rot and advanced cases of other indicated diseases, a
dosage level of 5 mg/lb of body weight per day is recommended.
Treatment should be continued 24-48 hours following remission of disease signs;
however, not to exceed a total of 4 consecutive days. Consult your veterinarian
if improvement is not noted within 24-48 hours of the beginning of treatment.

Swine: A single dosage of 9 mg of AGRIMYCIN® 200 per lb of body weight
administered intramuscularly in the neck region is recommended in the treatment
of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment
is impractical due to husbandry conditions or where repeated restraint is
inadvisable.

AGRIMYCIN® 200 can also be administered by intramuscular injection at a level of
3-5 mg of oxytetracycline per lb of body weight per day. Treatment should be
continued 24-48 hours following remission of disease signs; however, not to
exceed a total of 4 consecutive days. Consult your veterinarian if improvement
is not noted within 24-48 hours of the beginning of treatment.

For sows, administer once intramuscularly in the neck region 3 mg of oxytetracycline
per lb of body weight approximately 8 hours before farrowing or immediately after
completion of farrowing.

For swine weighing 25 lb of body weight and under, AGRIMYCIN® 200 should be
administered undiluted for treatment at 9 mg/lb but should be administered diluted
for treatment at 3 or 5 mg/lb.

* To prepare dilution, add 1 part AGRIMYCIN® 200 to 3, 5 or 7 parts of sterile water,
or 5% dextrose solution as indicated; the diluted product should be used immediately.

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE: AGRIMYCIN® 200 is intended for use in the treatment of
disease due to oxytetracycline-susceptible organisms in beef cattle; dairy
cattle; calves, including preruminating (veal) calves; and swine. A thoroughly
cleaned, sterile needle and syringe should be used for each injection (needles
and syringes may be sterilized by boiling in water for 15 minutes). In cold
weather, AGRIMYCIN® 200 should be warmed to room temperature before administration
to animals. Before withdrawing the solution from the bottle, disinfect the rubber
cap on the bottle with suitable disinfectant, such as 70% alcohol. The injection
site should be similarly cleaned with the disinfectant. Needles of 16-18 gauge and
1-1/2 inches long are adequate for intramuscular and subcutaneous injections.
Needles 2-3 inches are recommended for intravenous use.

Intramuscular Administration:

Intramuscular injections in swine should be made by directing the needle of suitable
gauge and length into the fleshy part of a thick muscle in the neck region; avoid
blood vessels and major nerves. Before injecting the solution, pull back gently on
the plunger. If blood appears in the syringe, a blood vessel has been entered;
withdraw the needle and select a different site. No more than 5 mL should be injected
at any one site in adult swine; rotate injection sites for each succeeding treatment.

Subcutaneous Administration:
Subcutaneous injections in beef cattle, dairy cattle, and calves, including
preruminating (veal) calves, should be made by directing the needle of suitable
gauge and length through the loose folds of the neck skin in front of the shoulder.
Care should be taken to ensure that the tip of the needle has penetrated the skin
but is not lodged in muscle. Before injecting the solution, pull back gently on the
plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw
the needle and select a different site. The solution should be injected slowly into
the area between the skin and muscles. No more than 10 mL should be injected
subcutaneously at any one site in adult beef and dairy cattle; rotate injection
sites for each succeeding treatment. The volume administered per injection site
should be reduced according to age and body size so that 1-2 mL per site is injected
in small calves.

Intravenous Administration:
AGRIMYCIN® 200 may be administered intravenously to beef and dairy cattle. As with all
highly concentrated materials, AGRIMYCIN® 200 should be administered slowly by the
intravenous route.

Preparation of the Animal for Injection:
1. Approximate location of vein. The jugular vein runs in the jugular groove on each
side of the neck from the angle of the jaw to just above the brisket and slightly
above and to the side of the windpipe. (See Fig. I) 

2. Restraint. A stanchion or chute is ideal for restraining the animal. With a halter,
rope, or cattle leader (nose tongs), pull the animal's head around the side of the
stanchion, cattle chute, or post in such a manner to form a bow in the neck (See Fig. II),
then snub the head securely to prevent movement. By forming the bow in the neck,
the outside curvature of the bow tends to expose the jugular vein and make it easily
accessible.

Caution: Avoid restraining the animal with a tight rope or halter around the throat or
upper neck which might impede blood flow. Animals that are down present no problem so far
as restraint is concerned.

3. Clip hair in area where injection is to be made (over the vein in the upper third of
the neck). Clean and disinfect the skin with alcohol or other suitable antiseptic.

Entering the Vein and Making the Injection:
1. Raise the vein. This is accomplished by tying the choke rope tightly around the neck close
to the shoulder. The rope should be tied in such a way that it will not come loose and so that
it can be untied quickly by pulling the loose end (See Fig. II). In thick-necked animals, a
block of wood placed in the jugular groove between the rope and the hide will help considerably
in applying the desired pressure at the right point. The vein is a soft flexible tube through
which blood flows back to the heart. Under ordinary conditions it cannot be seen or felt with
the fingers. When the flow of blood is blocked at the base of the neck by the choke rope, the
vein becomes enlarged and rigid because of the back pressure. If the choke rope is sufficiently
tight, the vein stands out and can be easily seen and felt in thin-necked animals. As a further
check in identifying the vein, tap it with the fingers in front of the choke rope. Pulsations
that can be seen or felt with the fingers in front of the point being tapped will confirm the
fact that the vein is properly distended. It is impossible to put the needle into the vein
unless it is distended. Experienced operators are able to raise the vein simply by hand pressure,
but the use of a choke rope is more certain. 

2. Inserting the needle. This involves 3 distinct steps. First, insert the needle through the hide.
Second, insert the needle into the vein. This may require 2 or 3 attempts before the vein is entered.
The vein has a tendency to roll away from the point of the needle, especially if the needle is not
sharp. The vein can be steadied with the thumb and finger of one hand. With the other hand, the needle
point is placed directly over the vein, slanting it so that its direction is along the length of the
vein, either toward the head or toward the heart. Properly positioned this way, a quick thrust of the
needle will be followed by a spurt of blood through the needle, which indicates that the vein has been
entered. Third, once in the vein, the needle should be inserted along the length of the vein all the
way to the hub, exercising caution to see that the needle does not penetrate the opposite side of the
vein. Continuous steady flow of blood through the needle indicates that the needle is still in the vein.
If blood does not flow continuously, the needle is out of the vein (or clogged) and another attempt
must be made. If difficulty is encountered, it may be advisable to use the vein on the other side of
the neck. 

3. While the needle is being placed in proper position in the vein, an assistant should get the
medication ready so that the injection can be started without delay after the vein has been entered.

4. Making the injection. With the needle in position as indicated by continuous flow of blood, release
the choke rope by a quick pull on the free end. This is essential - the medication cannot flow into
the vein while it is blocked. Immediately connect the syringe containing AGRIMYCIN® 200 to the needle
and slowly depress the plunger. If there is resistance to depression of the plunger, this indicates
that the needle has slipped out of the vein (or is clogged) and the procedure will have to be
repeated. Watch for any swelling under the skin near the needle, which would indicate that the medication
is not going into the vein. Should this occur, it is best to try the vein on the opposite side of the neck.

5. Removing the needle. When injection is complete, remove needle with straight pull. Then apply pressure
over area of injection momentarily to control any bleeding through needle puncture, using cotton soaked
in alcohol or other suitable antiseptic.

SPL UNCLASSIFIED SECTION

Not For Human Use
Approved by FDA under ANADA # 200-128

Manufactured for Huvepharma, Inc., Peachtree City, GA 30269

DOSAGE & ADMINISTRATION

Dosage: Cattle: A single dosage of 9 mg of oxytetracycline per lb of body weight
(4.5 mL/100 lb) administered subcutaneously is recommended in the treatment of
the following conditions: 1) bacterial pneumonia caused by Pasteurella spp.
(shipping fever) in calves and yearlings, where retreatment is impractical
due to husbandry conditions, such as cattle on range, or where repeated
restraint is inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye)
caused by Moraxella bovis.

Swine: A single dosage of 9 mg of oxytetracycline per lb of body weight
(4.5 mL/100 lb) administered intramuscularly is recommended in the treatment
of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment
is impractical due to husbandry conditions or where repeated restraint is
inadvisable.

Refer to Package Onsert for Complete Directions.

HOW SUPPLIED

How Supplied: AGRIMYCIN® 200 is available in 100 mL,
250 mL and 500 mL multi-dose amber vials.

STORAGE AND HANDLING

Storage: Store at room temperature
15°-25°C (59°-77°F). Keep from
freezing. Use within 12 months of first
puncture. Puncture a maximum of 100
times.

Not For Human Use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AGRIMYCIN  200
oxytetracycline injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-7430
Route of Administration	SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE (UNII: X20I9EN955) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PYRROLIDONE (UNII: KKL5D39EOL)
SODIUM FORMALDEHYDE SULFOXYLATE (UNII: X4ZGP7K714)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
Water (UNII: 059QF0KO0R)
Hydrochloric acid (UNII: QTT17582CB)
Monoethanolamine (UNII: 5KV86114PT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-7430-4	100 mL in 1 VIAL
2	NDC: 23243-7430-5	250 mL in 1 VIAL
3	NDC: 23243-7430-6	500 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200128	09/01/2016

Labeler - Huvepharma Inc (619153559)