Target Species
Cattle, sheep, pigs and horses.
Indications for use
For the treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep and pigs.
In vitro, oxytetracycline is active against a range of both Gram-positive and Gram-negative micro-organisms including:
Streptococcus spp., Staphylococcus spp., L. monocytogenes, M. haemolytica, H. parahaemolyticus and B. bronchiseptica and against Chlamydophila abortus, the causative organism of enzootic abortion in sheep.
Contraindications
Do not administer to horses during concomitant therapy with corticosteroids.
Do not use in cases of hypersensitivity to oxytetracycline or tetracycline antibiotics.
Special warnings for each target species
None.
Special precautions for use
As with other tetracyclines, caution should be exercised in treating horses under stress.
Operator warnings
People with known hypersensitivity to oxytetracycline or tetracycline antibiotics should avoid contact with the veterinary medicinal product.
Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Wash hands after use.
Adverse Reactions
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction1, Anaphylaxis1 |
1A veterinarian should be consulted immediately and appropriate treatment should be initiated.
Horses:
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylaxis1; Injection site swelling2 |
1 A veterinarian should be consulted immediately and appropriate treatment should be initiated.
2 Following intramuscular administration, transient.
Pigs and sheep:
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to tooth discolouration.
Interactions
None known.
Amounts to be administered and administration route
The veterinary medicinal product can be administered at either a low dose rate for a 24 hour duration of activity or at a high dose rate for prolonged duration of activity.
24 hour dosage regime:
Intramuscular use or intravenous use.
The recommended dosage is 3-10 mg/kg bodyweight (depending on age and species - see table) by intramuscular or intravenous injection. The treatment may be repeated at 24 hour intervals up to 4 times (5 treatments in total).
Intravenous injections must be given slowly over a period of at least one minute.
Prolonged action dosage regime:
Intramuscular use.
10 or 20 mg/kg bodyweight depending on age and species (see table) by intramuscular injection only, repeated once after 48-60 hours if required.
This dosage regime is not advised for use in horses.
Animal | Weight kg | 24 hour dosage | Prolonged action |
| | Dose mg/kg | Volume ml | Dose mg/kg | Volume ml |
Horse | 500 | 5 | 25 | Not recommended |
Foal | 100 | 10 | 10 | Not recommended |
Cow | 500 | 3 | 15 | 10 | 50 |
Calf | 100 | 8 | 8 | 20 | 20 |
Sow/boar | 150 | 5 | 7.5 | 10 | 15 |
Pig | 25 | 8 | 2 | 20 | 5 |
Sheep | 50 | 8 | 4 | 20 | 10 |
Lamb | 25 | 8 | 2 | 20 | 5 |
Prophylactic treatment of enzootic abortion in sheep: 20 mg/kg administered about day 95-100 of gestation. A further treatment may be given 2-3 weeks later.
Before administration, clean the area of the injection site and swab with spirit. Repeat doses should be administered at different sites, and the sites massaged well after injection.
Maximum recommended dose at any one site: 20 ml for cattle, 10 ml for sheep and pigs.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Overdose
Oxytetracycline has low toxicity but is irritant. Overdosage should be avoided, particularly in horses. No recommended treatment.
Withdrawal periods
24 hour dose
Milk: |
Cattle | 6 days |
Meat and offal: |
Cattle | 35 days |
Sheep | 14 days |
Pigs | 14 days |
Prolonged action dose
Milk: |
Cattle | 6 days |
Meat and offal: |
Cattle | 21 days |
Sheep | 14 days |
Pigs | 10 days |
Not for use in sheep producing milk for human consumption.
Not for use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.