NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Sunday, October 6, 2024 20:32

Release 2.139
Chronogest CR® 20 mg controlled release vaginal sponge for sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Other sex hormones
Active ingredient: Flugestone Acetate
Product:Chronogest CR® 20 mg controlled release vaginal sponge for sheep
Product index: Chronogest CR
Sheep - meat: 2 days after sponge removal
Withdrawal notes: Sheep milk: Zero hours including treatment time.
Incorporating:
Qualitative and quantitative composition
Each sponge contains:
Active substance:
17.9 mg flugestone equivalent to 20 mg flugestone acetate.
List of excipients:
Hydroxypropylcellulose 20 mg
Macrogol 4000 20 mg
For a full list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
White cylindrical polyester polyurethane medicated sponge equipped with string.
Clinical particulars
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.
Pharmacological particulars
Pharmacotherapeutic group: progestagen
ATC vet code: QG03D
Pharmacodynamic properties
Flugestone acetate is a synthetic analogue of progesterone. It is approximately 20 fold more potent than progesterone and displays progestational activity but no anti-progestational, anti-androgenic or androgenic properties together with a low glucocorticoid activity.
Owing to its binding to the progesterone receptors, flugestone acetate acts by negative feedback on the hypothalamo-pituitary axis, suppressing pituitary release of gonadotropins and therefore terminal follicular growth and ovulation.
Pharmacokinetic properties
Flugestone acetate is readily absorbed during the 12-14 days period of intra-vaginal administration. Tmax ranges between 8 and 24 h, whereas Cmax varies between 1.4 and 3.7 ng/ml. Steady state is reached quickly following onset of the treatment. Plasma cronolone concentrations are relatively constant throughout treatment. One day after removal of the Chronogest CR, flugestone acetate concentrations have dropped below the limit of quantification (LOQ = 0.04 ng/ml).
Flugestone acetate is metabolised into hydroxylated metabolites, which are excreted in faeces and urine.
Pharmaceutical particulars
Excipients
Hydroxypropylcellulose
Macrogol 4000
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Store below 25 °C.
Store in the original package.
Store in a dry place.
Once packaging is opened, any unused product should be discarded.
Immediate packaging
Bags made of polyester/aluminium/polyethylene containing 10 sponges, 25 sponges or 50 sponges.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5087
UK(NI): Vm 01708/3019
Significant changes
Date of the first authorisation or date of renewal
21 June 2005
Date of revision of the text
January 2024
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Chronogest CR 20mg 1x25spn:
GTIN:8713184039354