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Contra-indications, warnings, etc
Not to be used in animals known to be hypersensitive to the active ingredient.
Special precautions for use in animals
Not recommended for horses.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the product
Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical attention immediately. In the event of accidental skin contact, wash thoroughly with soap and water. Wash hands after use. Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Adverse reactions
Tolerance studies and toxicity studies suggest that undesirable effects are unlikely. Occasionally, swelling at the injection site may occur but this effect is transient.
Use during pregnancy and lactation
Reports of adverse reproductive effects have not been noted. Use with care in pregnant animals.
Overdose
Tolerance studies of up to 156% of the recommended dosage rate have been carried out with localised swelling at the injection site being the only adverse effect. The lowest recorded LD50 for tylosin from other acute toxicity studies was 400mg/kg bodyweight (40 times the recommended dosage rate) by intravenous injection in mice.
Withdrawal periods
Pigs should not be slaughtered for human consumption during treatment or for 46 days following the last injection.