NOROMYCIN 300 LA
- oxytetracycline injection, solution
Norbrook Laboratories Limited
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Approved by FDA under NADA # 141-143
Noromycin®
300 LA
(oxytetracycline injection)
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base (equivalent to 323.5 mg of oxytetracycline dihydrate).
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.
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.The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.
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.
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.
* To prepare dilutions, add one part of NOROMYCIN 300 LA to three (3), five (5) or seven (7) parts of the sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately. |
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9 mg dosage of undiluted
NOROMYCIN 300 LA | 3 or 5 mg/lb dosage of diluted NOROMYCIN 300 LA |
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Bodyweight | 9 mg/lb | 3 mg/lb | Dilution* | 5 mg/lb |
5 lb | 0.15 mL | 0.4 mL | 37.5 mg/mL | 0.7 mL |
10 lb | 0.30 mL | 0.6 mL | 50 mg/mL | 1.0 mL |
25 lb | 0.75 mL | 1.0 mL | 75 mg/mL | 1.7 mL |
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 11/2 inches long are adequate for intramuscular or subcutaneous injections. Needles of 2 to 3 inches in length are recommended for intravenous use.
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 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.
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:
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.
Store at controlled room temperature 20-25°C (68-77°F); excursions permitted 15-30°C (59-86°F). Protect from freezing. For 100 mL size: Use within 60 days of first puncture and puncture a maximum of 24 times. For 250 mL and 500 mL sizes: Use within 60 days of first puncture and puncture a maximum of 36 times. If using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use.
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.
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. To report a suspected adverse reaction call 1-866-591-5777.
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
Rev. August 2021
185670I04
Noromycin®
300 LA
(oxytetracycline injection)
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base (equivalent to 323.5 mg of oxytetracycline dihydrate).
For the treatment of disease in beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves and swine.
Approved by FDA under NADA # 141-143
Restricted Drug(s) California. Use only as Directed
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
Net Contents: 500mL
Norbook®
Noromycin®
300 LA
(oxytetracycline injection)
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base (equivalent to 323.5 mg of oxytetracycline dihydrate).
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
Approved by FDA under NADA # 141-143
Restricted Drug(s) California. Use only as Directed
U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053
Net Contents: 500mL
Norbook®
NOROMYCIN 300 LA
oxytetracycline injection, solution |
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Labeler - Norbrook Laboratories Limited (214580029) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Norbrook Laboratories Limited | 211218325 | ANALYSIS, LABEL, MANUFACTURE, PACK |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Chifeng Pharmaceutical Co. Limited | 528176051 | API MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Hebei Shengxue Dacheng Pharmaceutical Co. Ltd | 544867229 | API MANUFACTURE |