Bioestrovet 0.250 mg/ml Solution for Injection for Cattle

Composition

Each ml contains:

Active substance:

Cloprostenol 0.250 mg

(equivalent to Cloprostenol Sodium) 0.263 mg

Excipients:

A clear colourless aqueous solution.

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Pharmacological properties

4.1 ATCvet code:

QG02AD90.

4.2 Pharmacodynamics

Cloprostenol sodium, a (racemic) analogue of prostaglandin F2α (PGF2α), is a very potent luteolytic agent. It causes functional and morphological regression of the corpus luteum (luteolysis) in cattle followed by return to oestrus and normal ovulation.

Furthermore, this group of substances has a contractile effect on the smooth muscles (uterus, gastro-intestinal tract, respiratory tract, vascular system).

The veterinary medicinal product does not demonstrate any androgenic, oestrogenic or anti progesterone activity and its effect on pregnancy is due to its luteolytic property.

Unlike other prostaglandin analogues, cloprostenol has no thromboxane A2 activity and does not cause platelet aggregation.

4.3 Pharmacokinetics

Metabolism studies, using 15 - 14C-closprostenol have been performed in cattle (by i.m. administration) to determine residue levels.

The kinetic studies indicate that the compound is rapidly absorbed from the site of injection, is metabolised then excreted in approximately equal proportion in urine and faeces.

In cattle, less than 1% of the administered dose is eliminated via milk. The major route of metabolism appears to be β-oxidation to the tetranor or dinor acids of cloprostenol. Peak values of radioactivity in blood were observed within 1 hour of a parenteral dose and declined with a t ½ of between 1 - 3 hours depending on species.

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Target species

Cattle (heifers, cows).

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Indications

Cattle (heifers, cows):

- Oestrus induction and synchronisation in cows and heifers with a functional corpus luteum.

- Induction of oestrus as an aid to management of suboestrus (‘silent heat’).

- Treatment of clinical and subclinical endometritis in the presence of a functional corpus luteum.

- Treatment of ovarian luteal cysts.

- Induction of abortion up to day 150 of gestation.

- Induction of parturition after day 270 of gestation.

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Dosage

For intramuscular use.

One dose equals 0.5 mg cloprostenol/animal corresponding to 2 ml of the veterinary medicinal product per animal.

Oestrus induction and synchronisation:

Administer one dose per animal. When no oestrus symptoms are observed, a second dose can be administered after 11 days.

Treatment of clinical and subclinical endometritis in the presence of a functional corpus luteum.:

Administer one dose per animal. If necessary, repeat the treatment 10-14 days later.

Treatment of ovarian luteal cysts:

Administer a single dose per animal.

Induction of parturition:

Administer a single dose per animal, not earlier than 10 days before the expected date of calving.

Induction of abortion up to day 150 of gestation:

Administer a single dose per animal, between the 5th and the 150th day of gestation.

It is recommended that the vial is not broached more than 10 times and that the appropriate vial size is used for prevailing usage conditions. Otherwise, automatic syringe equipment, or a suitable draw-off needle, should be used for the 50 ml and 100 ml vials to avoid excessive puncturing of the stopper.

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Contraindications

Do not use in pregnant animals in which the induction of abortion or parturition is not intended.

Do not administer to induce parturition in animals with suspected dystocia due to mechanical obstruction or abnormal position, presentation and/or posture of the foetus.

Do not use in animals with compromised cardiovascular function, bronchospasm or gastro-intestinal dysmotility.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Cattle (heifers, cows):

1 May occur if anaerobic bacteria enter the injection site, especially following intramuscular injection, and may become generalized. Aggressive antibiotic therapy, particularly covering clostridial species, should be employed at the first sign of infection. Careful aseptic techniques should be employed to decrease the possibility of these infections.

2 Requiring immediate medical attention. Can be life-threatening.

3 Cloprostenol may cause effects similar to Prostaglandin F2α activity in the smooth muscles.

4 May be caused by induction of parturition. As part of induction of parturition, depending on the date of treatment versus the date of conception, the incidence of placental retention may be increased.

5 In case of occurrence, these effects are observed within 15 minutes post-injection and usually disappear after one hour.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be avoided. Thoroughly clean and disinfect injection sites prior to administration.

Do not administer intravenously.

All animals should receive adequate supervision after treatment.

Induction of parturition or abortion may cause dystocia, stillbirth and/or metritis. The incidence of retained placenta may be increased depending on the time of treatment relative to the date of conception.

Injection into adipose tissue can result in incomplete absorption of the veterinary medicinal product.

Cloprostenol may cause effects related to Prostaglandin F2α activity in the smooth muscles, such as increased frequency of urination and defecation.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Prostaglandins of the F2α-type, such as cloprostenol, can be absorbed through the skin and may cause bronchospasm or miscarriage. Care should be taken when handling the product to avoid self-injection or skin contact.

Pregnant women, women of child-bearing age, asthmatics and people with other respiratory tract diseases should avoid any contact with the veterinary medicinal product.

Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.

Accidental spillage on the skin should be washed immediately with soap and water.

In case of accidental self-injection or spillage onto skin, seek medical advice immediately, particularly as shortness of breath may occur, and show the package leaflet or the label to the physician.

This veterinary medicinal product may cause hypersensitive reactions. People with known hypersensitivity to chlorocresol should avoid contact with the veterinary medicinal product.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Do not use in pregnant animals in which the induction of abortion or parturition is not intended.

Lactation:

The product can be used during lactation.

Fertility:

Cloprostenol has a large safety margin and does not negatively affect fertility in cattle. Nor have any harmful effects been reported in the offspring of an insemination or mating following treatment with this veterinary medicinal product for conception products obtained after treatment.

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Interactions

The concomitant use of oxytocin and cloprostenol increases the effects on the uterus.

Do not administer with non-steroidal anti-inflammatory drugs (NSAIDs) since they inhibit endogenous prostaglandin synthesis.

The concomitant use of progestogens decreases the effect of cloprostenol.

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Overdose

At 5x to 10x overdose the most frequent side effect is increased rectal temperature. This is usually transient, however, and not detrimental to the animal. Limited salivation or transient diarrhoea may also be observed in some animals.

There are no antidotes available, treatment should be symptomatic, assuming that prostaglandin F2α influences the smooth muscle cells.

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Special warnings

There is a refractory period of four to five days after ovulation when cattle are insensitive to the luteolytic effect of prostaglandins.

For the termination of gestation, best results are obtained before day 100 of gestation. Results are less reliable between day 100 and 150 of gestation.

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Withdrawal period

Meat and offal: 1 day

Milk: Zero hours

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Type 1 (colourless) glass vial closed with bromobutyl rubber stopper coated with a FluroTec film (ETFE) and a polypropylene flip-off cap.

Cardboard box containing 1 vial of 20 ml.

Cardboard box containing 1 vial of 50 ml.

Cardboard box containing 1 vial of 100 ml.

Not all pack sizes may be marketed.

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Storage

Keep the vial in the outer carton in order to protect from light.

This veterinary medicinal product does not require any special temperature storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as cloprostenol may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 08007/5035

8 DATE OF FIRST AUTHORISATION

10 April 2017

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

November 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Vetoquinol UK Limited

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