Label: VETRIMYCIN 200- oxytetracycline injection

Vetrimycin™ 200
(oxytetracycline injection)
Antibiotic

Vetrimycin™ 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.

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.

Distributed by: MWI
Boise, ID 83705
www.VetOne.net

LOT NO.:                EXP. DATE:

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: Vetrimycin™ 200 is available in 100 mL, 250 mL and 500 mL
multi-dose amber vials.

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

Vetrimycin™ 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 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.

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

Vetrimycin™ 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.

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

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 Oxytetracycline Injection in conjunction with
penicillin.

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: 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.

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 Oxytetracycline Injection show a noticeable
improvement within 24-48 hours.

INDICATIONS: Vetrimycin™ 200 (oxytetracycline injection) 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: Vetrimycin™ 200 (oxytetracycline injection) 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: Vetrimycin™ 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, Vetrimycin™ 200 is indicated as an aid in the control of infectious enteritis
(baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

DOSAGE:

Cattle: Vetrimycin™ 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 Vetrimycin™ 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.

Vetrimycin™ 200 (oxytetracycline injection) 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 Vetrimycin™ 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.

Vetrimycin™ 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, Vetrimycin™ 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 Vetrimycin™ 200 (oxytetracycline
injection) to 3, 5 or 7 parts of sterile water, or 5% dextrose solution
as indicated; the diluted product should be used immediately.

DIRECTIONS FOR USE: Vetrimycin™ 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, Vetrimycin™ 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:
Vetrimycin™ 200 (oxytetracycline injection) may be administered intravenously to beef and
dairy cattle. As with all highly concentrated materials, Vetrimycin™ 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 Vetrimycin™ 200 (oxytetracycline
injection) 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.

Not For Human Use

Approved by FDA under ANADA # 200-128

Distributed by: MWI
Boise, ID 83705
www.VetOne.net

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: Vetrimycin™ 200 is available in 100 mL, 250 mL and 500 mL
multi-dose amber vials.

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