Do not use in horses, dogs and cats.
Do not use in animals with hepatic or renal damage.
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
Special Warnings for Each Target Species
None.
Special Precautions for Use in Animals
Do not dilute the product
If concurrent treatment is administered, use a separate injection site
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official and local antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance.
Special Precautions to be taken by the Person Administering the Veterinary Medicinal Product to Animals
This product may cause sensitisation.
People with known hypersensitivity to tetracyclines, such as oxytetracycline, should avoid contact with the product.
This product may cause skin and eye irritation.
Avoid contact of the skin and eyes with the product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water.
Take care to avoid accidental injection. In case of self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Adverse Reactions (Frequency and Seriousness)
Although the product is well tolerated, occasionally a slight local reaction of a transient nature has been observed.
Tetracyclines have also been associated with photosensitivity reactions and, rarely, hepatotoxicity and blood dyscrasias.
Oxytetracycline given to young animals can cause a yellow, brown or grey discolouration of bones and teeth. High dose or chronic administration may delay bone growth or healing.
Use During Pregnancy and Lactation
The product can be safely administered to lactating animals.
The active substance, oxytetracycline, readily crosses the placenta and concentrations in the foetal blood may reach those of the maternal circulation, although the concentration is usually somewhat lower. Tetracyclines are deposited in teeth, causing discolouration, enamel hypoplasia and reduced mineralisation. Tetracyclines can also retard foetal skeletal development. As such, the product should only be used in the last half of pregnancy following risk benefit assessment by the responsible veterinarian.
Oxytetracycline is excreted in milk; concentrations are generally low.
Interaction with Other Medicinal Products and Other Forms of Interaction
Oxytetracycline should not be administered simultaneously with bactericidal antimicrobials, such as penicillins and cephalosporins.
Divalent or trivalent cations (Mg, Fe, Al, Ca) can chelate tetracyclines.
Overdose (Symptoms, Emergency Procedures, Antidotes)
There is no known specific antidote, if signs of possible overdose occur treat the animal symptomatically.
Withdrawal Period(s)
Cattle:
Meat and offal: 31 days
Milk: 10 days
Sheep:
Meat and offal: 9 days
Milk: 7 days
Pigs:
Meat and offal: 18 days