Veterinary Drug Handbook (VDH) is the reference veterinarians turn to when they want an independent source of information on the drugs that are used in veterinary medicine today.

Noromycin 300 LAOxytetracycline Injection 300 mg/mL

Product Type: OTC ANIMAL DRUG LABEL
Autor Name: Norbrook Laboratories Limited
Code Source: 55529-015
Route of Administration: SUBCUTANEOUS

Noromycin 300 LA

Generic: oxytetracycline

Ingredients:

  • oxytetracycline oxytetracycline : Active ingredient - basis of strength - 300 mg in 1 mL
  • glycerol formal : Inactive ingredient
  • polyethylene glycol : Inactive ingredient
  • magnesium oxide : Inactive ingredient
  • sodium formaldehyde sulfoxylate : Inactive ingredient

Package Description:

  • 100 mL in 1 VIAL, GLASS
  • 250 mL in 1 VIAL, GLASS
  • 500 mL in 1 VIAL, GLASS

NADA 141-143, APPROVED BY FDA
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.
For Use in Beef Cattle, Non-lactating Dairy Cattle, Calves, Including Pre-ruminating (Veal) Calves and Swine.
READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.

INTRODUCTION:

NOROMYCIN 300 LA is a sterile, ready to use solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Oxytetracycline is an antimicrobial agent that is effective in treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.
NOROMYCIN 300 LA should be stored at room temperature 59 °-86°F (15°-30°C). The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

INDICATIONS:

NOROMYCIN 300 LA is intended for use in treatment for the following diseases when due to oxytetracycline-susceptible organisms:

Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves:

NOROMYCIN 300 LA is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. NOROMYCIN 300 LA is indicated for the treatment of infectious bovine keratoconjunctivitis (pink eye) 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 staphylococcal and streptococcal organisms sensitive to oxytetracycline.

Swine:

NOROMYCIN 300 LA 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 NOROMYCIN 300 LA is indicated as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

DOSAGE AND ADMINISTRATION: Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves:

A single dosage of 9 mg of oxytetracycline per pound of bodyweight administered intramuscularly or subcutaneously is recommended in the treatment of the following conditions:
For other indications NOROMYCIN 300 LA is to be administered intramuscularly, subcutaneously or intravenously at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. In treatment of foot-rot and advanced cases of other indicated diseases, a dosage level of 5 mg per pound of bodyweight per day is recommended. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated by a veterinarian.
Do not administer intramuscularly in the neck of small calves due to lack of sufficient muscle mass.
Use extreme care when administering this product by intravenous injection. Perivascular injection or leakage from an intravenous injection may cause severe swelling at the injection site.

Swine:

A single dosage of 9 mg of oxytetracycline per pound of bodyweight 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.
NOROMYCIN 300 LA can also be administered by intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated by a veterinarian.
For sows, administer once intramuscularly 3 mg of oxytetracycline per pound of bodyweight approximately eight (8) hours before farrowing or immediately after completion of farrowing as an aid in the control of infectious enteritis in baby pigs.
For swine weighing 25 lbs of bodyweight and under, NOROMYCIN 300 LA should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

DIRECTIONS FOR USE:

NOROMYCIN 300 LA is intended for use in the treatment of disease due to oxytetracycline-susceptible organisms in beef cattle, non-lactating dairy cattle and swine. A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilised by boiling in water for 15 minutes). In cold weather NOROMYCIN 300 LA 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 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16 to 18 gauge and 1 to 1 ½ inches long are adequate for intramuscular or subcutaneous injections. Needles of 2 to 3 inches in length are recommended for intravenous use.

INTRAMUSCULAR ADMINISTRATION:

Intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle such as in the neck, rump, hip, or thigh regions; 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 10 mL should be injected intramuscularly at any one site in adult beef cattle and non-lactating dairy cattle, and not more than 5 mL per site in adult swine; 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 to 2 mL per site is injected in small calves.

SUBCUTANEOUS ADMINISTRATION:

Subcutaneous injections 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 the 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 cattle and non-lactating 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 to 2 mL per site is injected in small calves.

INTRAVENOUS ADMINISTRATION

NOROMYCIN 300 LA may be administered intravenously to beef cattle and non-lactating dairy cattle. As with all highly concentrated materials, NOROMYCIN 300 LA should be administered slowly by the intravenous route.

Preparation of the Animal for Injection:


Entering the Vein and Making the Injection:



PRECAUTIONS:

Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef cattle and non-lactating dairy cattle and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal time.
Consult with your veterinarian prior to administering this product in order to determine the proper treatment required in the event of an adverse reaction. 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 attributable 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. The absence of a favourable response following treatment, or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving NOROMYCIN 300 LA in conjunction with penicillin.

STORAGE:

Store at room temperature, 59-86 °F (15-30°C). Keep from freezing.

WARNINGS:

Warnings: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Not for use in lactating dairy animals. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes.

CAUTION:

Intramuscular or subcutaneous injection may result in local tissue reactions which persists beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.
Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site. Subcutaneous injection in the neck area may cause swelling at the injection site.

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 either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

PRESENTATION:

NOROMYCIN 300 LA is available in 100 mL, 250 mL and 500 mL vials.
Livestock Drug - Not for Human Use. Restricted Drug(s) California. Use Only as Directed.
DISTRIBUTED BY: Norbrook, Inc.
Lenexa, KS 66219
MADE IN THE UK
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
057670I03
Norbrook

Principal Display Panel - Vial Label

Noromycin 300 LA
Oxytetracycline Injection 300 mg/mL
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.
For the treatment of disease in beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves and swine.
FOR USE IN ANIMALS ONLY
NADA 141-143, Approved By FDA
Restricted Drug(s) California. Use only as Directed
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
Net Contents: 100mL
Norbrook ®

Principal Display Panel - Vial Label
Noromycin 300 LAOxytetracycline Injection 300 mg/mL

Principal Display Panel - Carton

Noromycin 300 LA
Oxytetracycline Injection 300 mg/mL
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.
For the treatment of disease in beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves and swine.
FOR USE IN ANIMALS ONLY
NADA 141-143, Approved By FDA
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
Net Contents: 100mL
Norbrook ®

Principal Display Panel - Carton
Noromycin 300 LAOxytetracycline Injection 300 mg/mL

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