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Contra-indications, warnings, etc
Do not use in cows or heifers with abnormal or immature genital tracts, or with genital infections. Do not use in pregnant cattle. Do not use within the first 35 days after calving.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Animals in poor condition, whether from illness, inadequate nutrition or other factors may respond poorly to treatment.
Cattle (cows and heifers):
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Vaginal discharge1, vulva irritation / vaginal irritation
1 observed at removal of insert, this discharge generally clears between the time of removal and the insemination and has not been seen to affect conception rates following treatment.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
The safety of the veterinary medicinal product has not been established during pregnancy. Do not use in pregnant cattle or within the first 35 days after calving. Laboratory studies in rat and rabbit, after intramuscular or subcutaneous administrations, and at repeated high doses of progesterone, have shown evidence of foetotoxic effects.
Can be used during lactation.
Ensure correct administration of the product, including the use of a non-irritant antiseptic and lubricant (see administration instructions).
Withdrawal periods:
Meat & offal – zero days.
Milk – zero days.
Operator warnings:
Progesterone is a potent steroid hormone and may cause adverse effects on the reproductive system in cases of high or prolonged exposure. As adverse effects on unborn children cannot be ruled out, pregnant women should avoid using this veterinary medicinal product.
The veterinary medicinal product may cause skin and eye irritation as well as allergic skin rashes.
Avoid accidental contact with the eyes. In case of accidental ocular exposure, flush the eyes thoroughly with water.
Persons administering the veterinary medicinal product should avoid contact with the silicone section; pregnant women should completely avoid handling the veterinary medicinal product.
The device should be inserted using the veterinary medicinal product specific applicator.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product during insertion and removal.
Wash hands and exposed skin with soap and water after use.
Do not eat, drink or smoke while handling the veterinary medicinal product.