ESTROVET (solution for injection)

ESTROVET (solution for injection)
Ingredients: cloprostenol sodium salt
Application: Injection
Type of formulation: hormone

Description

Clear, colourless to pale yellow liquid with a characteristic odour.

Composition

Each 1 ml of the product contains the active substance:
- сloprostenol sodium - 0,25 mg.
Excipients: chlorocresol, propylene glycol, sodium citrate, citric acid, sodium chloride, water for injections.

Pharmacological Properties

The active substance of the product is cloprostenol, a synthetic functional analogue of prostaglandin F2α (PGF2α).

PGF2α and its analogues (cloprostenol and fluprostenol) are potent luteolytic agents. They induce rapid involution of the corpus luteum and suppression of its secretory activity. Prostaglandins stimulate uterine muscle contractions.

In animals with a normal oestrous cycle, oestrus generally occurs 2–5 days after treatment. Pregnant cows administered the product during gestation (days 10–150) abort 2–3 days after administration.

Cloprostenol is approved in EU member states for use in beef and dairy cattle for the purpose of stimulating luteolysis.

Following intramuscular administration, cloprostenol is rapidly absorbed into the systemic circulation. Maximum plasma concentration is reached within 90 minutes, followed by a sharp decline 90–120 minutes post-administration. Single doses of 0,175 mg, 0,25 mg, and 1,0 mg result in a dose-dependent increase in plasma concentration. Upon repeated administration of higher doses, plasma cloprostenol concentration remains at the same level for 24 hours. The first signs of oestrus are observed 48–60 hours after administration. The most favourable time for artificial insemination is approximately 76 hours after administration. When administered to sows after day 111 of gestation, the majority of induced farrowings occur within 40 hours, with the peak number of farrowings observed between 24–35 hours.

Indications

The product is indicated for the regulation of the oestrous cycle in cows and sows. 

Cattle (cows): 
- suboestrus (silent heat) in cows with a normal cycle; 
- pyometra and chronic endometritis; 
- luteal cysts; induction of parturition; 
- termination of unwanted pregnancy; 
- mummified foetus; 
- oestrus synchronisation. 

Pigs (sows): induction of farrowing.

Dosage and Administration

The product is administered intramuscularly.
Cows:
For oestrus synchronization, administer 2 ml of the product twice with a 10-day interval. The first administration is given 40–60 days post-partum; the second on day 11 after the first administration. Artificial insemination is recommended 70–80 hours after the second administration and repeated 24 hours later.

For ovarian dysfunction, administer 2 ml of the product and perform artificial insemination at the first observed oestrus. If oestrus does not occur, re-administer the product on day 11 after the first administration and repeat artificial insemination 72–76 hours later.

For uterine disorders, administer 2 ml of the product; repeat the administration on day 11, and perform artificial insemination on day 14, repeating it 24 hours later.

Sows:
For induction of farrowing, administer 0,7 ml of the product as a single injection on day 111 of gestation. Induced farrowings occur 24–35 hours after administration.

Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 
Do not use in pregnant animals unless induction of parturition or therapeutic abortion is desired.
Cloprostenol must not be administered to pregnant animals that do not require stimulation of parturition.

Precautions

Withdrawal period
Animals may be slaughtered for meat 24 hours after the last administration. Milk may be used for human consumption without restriction.
Do not administer intravenously. When using the product to induce parturition, ensure that no obstacles to normal delivery are present (oversized fetus, malpresentation, obstructed birth canal) in order to avoid uterine rupture.

Packaging

2 ml neutral glass ampoules or vials (Type I/II, e.g., NS-1, NS-2, USP-1).
5, 10, 20, 50, and 100 ml neutral glass vials (Type I/II, e.g., NS-1, NS-2, USP-1) closed with rubber stoppers and sealed with aluminium caps. Secondary packaging: cardboard box.

Storage

Store in a dark place out of reach of children, at a temperature between 5°C and 25°C.

Shelf life

2 years from the date of manufacture, provided that the user complies with transportation, storage, and handling conditions.
Shelf life after first opening the immediate packaging: 14 days (store at 2 °C to 8 °C and withdraw aseptically).
For veterinary use only!

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