Target species
Sheep (ewes and ewe-lambs).
Indications for use
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum Gonadotrophin)
- Induction and synchronization of oestrus and ovulation (non cycling ewes during seasonal anoestrus and ewe lambs).
- Synchronization of oestrus and ovulation (cycling ewes and ewe-lambs).
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
- The repeated treatment with the product combined with PMSG may trigger the appearance of PMSG antibodies in some ewes. This in turn may affect the time of ovulation and result in reduced fertility when combined with fixed time artificial insemination at 55h following sponge removal.
- The repeated use of sponges within one year has not been studied.
- The use of a vaginal applicator designed for ewes or ewe lambs is recommended to correctly insert sponges and to avoid vaginal injuries.
Operator warnings
Personal protective equipment consisting of single use gloves should be worn when handling the veterinary medicinal product.
The veterinary medicinal product should not be administered by pregnant women or women suspected to be pregnant.
Direct contact with the skin should be avoided.
If accidental contact with the skin occurs, wash the affected zone with soap and water.
Wash hands after treatment and before meals.
Human exposure to this product can affect fertility.
Adverse reactions
Sheep (ewe and ewe lamb).
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vaginal discharge1 |
1 muco-purulent discharge may be observed at sponge removal. It is not associated with clinical signs and does not alter fertility.
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 also section “Contact details” of the package leaflet.
Use during pregnancy or lactation
The use is not recommended during gestation.
Can be used during lactation.
Interactions
The sponges should not be used in conjunction with alcohols, cresols, phenols, sheep dips or similar disinfectants.
Amounts to be administered and administration route
The dose is one sponge per animal irrespective of body weight, breed, type (dairy or meat) and season.
The sponge is inserted intra-vaginally using an applicator.
Duration of sponge residence is 14 days. At the end of the administration period, the sponge is gently removed by pulling on its string.
To obtain an optimal synchronization of ovulation, an intra-muscular injection of PMSG (range 300-700 IU) is recommended (i.m.) at the time of sponge removal.
In case fixed time artificial insemination is applied, it is recommended to perform it 55 h after sponge removal.
Overdose
A five time overdose of flugestone acetate (100 mg/sponge) did not result in observable side effects.
Withdrawal periods
Meat and offal: 2 days after withdrawal of sponges.
Milk: zero hours, including the treatment time.