Target species
Horses (mares).
Indications for use
In mares with significant follicular activity during the transitional period between seasonal anoestrus and the breeding season (follicles of at least 20-25 mm present at the beginning of treatment):
•Suppression/prevention of oestrus (usually after 1 to 3 days of treatment) during the prolonged oestrus periods occurring during this period.
•Control of the time of initiation of oestrus (approximately 90% of mares show signs of oestrus within 5 days following the end of treatment) and synchronization of ovulation (60% of mares ovulate between days 11 and 14 following the end of treatment).
Contraindications
Do not use in mares where uterine infection has been diagnosed.
Do not use in males.
Special warnings for each target species
In order to ensure effective use of the product, the presence of follicular activity in mares must be confirmed during the transitional period.
Special precautions for use
The medicated feed should be offered to mares being treated as soon as the product has been added, and not stored. Part consumed feed must be safely destroyed and not given to any other animal.
Operator warnings
Accidental exposure to this veterinary medicinal product could lead to disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy or headache. Adverse reproductive effects reported in men include decreased libido.
Acute effects after single exposure are possible, but repeated accidental exposure has the potential for more adverse effects.
The veterinary medicinal product should not be administered by women who are or suspected to be pregnant. Women of childbearing age should avoid contact with the veterinary medicinal product.
This veterinary medicinal product should not be handled by:
- persons with known or suspected breast cancer or other progesterone-dependent tumours
- persons with thrombo-embolic disorders or a history of those
- persons with cerebral-vascular or coronary-artery disease
- women with vaginal bleeding of unknown cause
- persons with liver dysfunction or disease.
People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product.
Avoid contact with skin, eyes and oral ingestion due to hand-to-mouth contact.
Personal protective equipment consisting of overalls and chemical resistant single-use gloves (e.g. nitrile gloves) should be worn when handling the veterinary medicinal product. This veterinary medicinal product can penetrate latex or other types of porous gloves and absorption through the skin may be even higher when the area is covered by an occlusive material.
Do not eat, drink or smoke while handling the product.
Wash hands after use.
In case of accidental spillage onto skin it should be washed off immediately with soap and water. Remove contaminated clothing immediately. In case of accidental contact with the eyes, rinse thoroughly with water for 15 minutes. In case of accidental ingestion do not induce vomiting as pulmonary damage via aspiration of oil base may occur. Seek medical advice immediately and show the package leaflet or the label to the physician.
Any equipment or surfaces that come into contact with the veterinary medicinal product should be adequately cleaned and decontaminated to prevent human exposure. Wear gloves when cleaning.
Adverse reactions
Horses (mares):
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Uterine infection |
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
Pregnancy:
Not applicable.
However, accidental administration is not detrimental as studies in mares have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Lactation:
Use during lactation is unlikely to have detrimental effects.
Interactions
Griseofulvin may alter the effects of altrenogest if administered concomitantly with this product.
Amounts to be administered and administration route
Oral use.
0.044 mg altrenogest per kg bodyweight per day, for 10 consecutive days.
Carefully withdraw the volume of veterinary medicinal product corresponding to the mare bodyweight (1 ml per 50 kg bodyweight) and administer this volume via oral route.
- 150, 300 and 1000 ml bottles: Wearing gloves remove the original cap and in its place screw on the luer lock cap. Keeping the bottle upright, screw the syringe onto the luer lock cap orifice, turn the bottle upside down, and carefully withdraw the solution from the bottle using the syringe.
Turn the bottle right way up before detaching the syringe. Securely replace the small cap on the luer lock cap.
- 250 ml bottles: Remove the white cap and the aluminium foil seal from the neck of the measuring compartment. Keeping the bottle upright, press the body of the bottle until the required volume of veterinary medicinal product is accumulated into the measuring compartment. Carefully pour the content of the measuring compartment on the mare feed.
The veterinary medicinal product should be added to the mare’s feed, at a single feeding per day, or directly administered into the mouth using a syringe.
Avoid introduction of contamination.
Overdose
No negative effects have been observed in horses following up to five times the recommended dose of altrenogest for 87 days and at the recommend dose for continuous periods up to 305 days.
Withdrawal periods
Meat and offal: 9 days.
Not authorised for use in lactating animals producing milk for human consumption.