Target species
Pigs (sow, nullipar)
Indications for use, specifying the target species
For the synchronisation of oestrus and improvement of litter size in sexually mature gilts. For the synchronisation of oestrus and improvement of farrowing rate and litter size in sows.
Contraindications
Do not administer to male animals. Do not administer to pregnant sows or those suffering from uterine infection. Part-consumed feed must be disposed of with other waste feed and not given to other animals.
Special warnings for each target species
None.
Special precautions for use
Not applicable.
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.
The veterinary medicinal product should not be handled by:
− People with known or suspected breast cancer or other progesterone-dependent tumours
− People with thromboembolic disorders or a history of those
− People with cerebrovascular or coronary artery disease
− Women with vaginal bleeding of unknown cause
− People 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, wash off immediately with soap and water. Remove contaminated clothing immediately. In case of accidental contact with 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.
Special precautions for the protection of the environment
When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Adverse reactions
Pigs (sows and gilts):
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
Pregnancy:
Do not use (during the whole or part of the pregnancy).
Interactions
None known.
Amounts to be administered and administration route
Oral use.
Ensure the correct dose is administered daily as under-dosing can lead to the formation of cystic follicles.
Gilts:
One dose of 5 ml per gilt per day for 18 consecutive days given orally with feed for immediate consumption.
Sows:
One dose of 5 ml per sow per day for 3 consecutive days given orally with feed for immediate consumption.
Group feeding on the floor:
Feed should be presented in such a manner that each pig is allowed sufficient floor space to get equal access to the feed.
Once the animals have started feeding, dispense one dose of the veterinary medicinal product as a top-dressing on the feed in front of each pig.
Administration:
- Remove the cap and the obturator.
- Measure the clinical dose of 5 ml using the dosing cup provided.
- Pour the dose on the feed.
- Close the bottle with the obturator and the screwable cap after each use.
Overdose
No special precautions required. Doses of 20 times the recommended dose did not affect pigs nor their offspring.
Withdrawal periods
Meat and offal: 9 days.