Enzaprost 5 mg/ml Solution for Injection for Cattle and Pig

Composition

Each ml contains:

Active substance:

Dinoprost (as trometamol)...............................................................5 mg

Excipients:

Clear colourless solution.

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Pharmacological properties

4.1 ATCvet code: QG02AD01

4.2 Pharmacodynamics

Dinoprost (as trometamol) has a luteolytic activity and provokes the involution of the corpus luteum in most mammalian species and the appearance of oestrus and ovulation in females having a cyclic sexual activity.

Administration of dinoprost provokes abortion or parturition in bovine and porcine species.

Moreover, it has other activities, which vary according to the different species such as increase of blood pressure and bronchial constriction. Dinoprost is also a stimulant of smooth muscle fibres.

4.3 Pharmacokinetics

In all the species, dinoprost (or PGF2 α) is rapidly absorbed from the injection site. The maximum concentrations (Cmax) in plasma of 13,14-dihydro-15-ketoprostaglandin F2alpha (PGFM), the major metabolite of PGF2 α, are around 15 mcg/L for bovine and 382 mcg/L for porcine and are obtained after 19 min for bovine and after 10 min for porcine.

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Target species

Cattle: cows, heifers.

Pigs: sows, gilts

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Indications

The product is indicated for its luteolytic effects in cattle and pigs.

Cattle

The luteolytic effect of the veterinary medicinal product can be exerted in the following therapeutic uses:

1. Oestrus synchronisation.

2. Treatment of sub-oestrus or silent heat in cows which have a functional corpus luteum, but do not express behavioural oestrus.

3. Induction of abortion until day 120 of pregnancy.

4. Induction of parturition.

5. As an aid in the treatment of chronic metritis or pyometra where there is a functional or persistant corpus luteum.

Pigs

1. Induction of parturition from day 111 of pregnancy.

2. Post partum use: reduction of the weaning to oestrus interval (WOI) and the weaning to fertile service interval (WFSI) in sows with puerperal problems such as metritis in herds with reproductive problems

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Dosage

Intramuscular use.

Full aseptic precautions should be taken. Use a sterile syringe and needle and make the injection through an area of clean skin. Care should be taken to avoid injection through wet or dirty areas of skin.

Cattle

1. Oestrus synchronisation:

One administration of 25 mg of dinoprost (as trometamol), ie 5 ml of the product per animal, to be repeated, if necessary after 11 (10 to 12) days.

Animals treated during dioestrus will normally return to oestrus and ovulate within two to four days after treatment.

Animals treated with the product may be bred by natural service, artificial insemination on detected oestrus or at fixed time insemination (72 and 96 hours after the second injection is usually recommended).

2. Treatment of sub-oestrus or silent heat in cows which have a functional corpus luteum, but do not express behavioural oestrus:

One administration of 25 mg of dinoprost (as trometamol), ie 5 ml of the product per animal, to be repeated, if necessary after 11 (10 to 12) days.

3. Induction of abortion until day 120 of pregnancy:

One administration of 25 mg of dinoprost (as trometamol), ie 5 ml of the product per animal.

The product may be used to terminate pregnancy in cattle until day 120 of pregnancy through its luteolytic effect.

4. Induction of parturition:

One administration of 25 mg of dinoprost (as trometamol), ie 5 ml of the product per animal on or after day 270 of gestation.

The interval from administration to parturition is one to eight days (average three days).

5. For the aid in the treatment of chronic metritis or pyometra where there is a functional or persistent corpus luteum:

One administration of 25 mg of dinoprost (as trometamol), ie 5 ml of the product per animal, to be repeated, if necessary after 11 (10 to 12) days.

Pigs

To avoid excessive broaching of the stopper when treating large numbers of animals using the 50 ml pack size, the use of a multiple dose syringe with a draw-off needle is recommended.

1. Induction of parturition from day 111 of pregnancy:

One administration of 10 mg of dinoprost (as trometamol), ie 2 ml of the product per animal within 3 days of expected parturition.

Response to treatment by individual animals varies within a range of 24-36 hours from administration to parturition. This can be used to control the time of farrowing in sows and gilts in late gestation. Treatment earlier than 3 days prior to predicted farrowing date may induce weak piglets.

2. Post-partum use:

One administration of 10 mg of dinoprost (as trometamol), ie 2 ml of the product per animal 24 to 36 hours after parturition.

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Contraindications

Do not treat animals if they suffer from either acute or subacute disorders of the vascular system, gastro-intestinal tract or respiratory system.

Do not administer to pregnant animals, unless it is desirable to induce parturition or interruption of pregnancy.

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

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Adverse reactions

Cattle:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Hyperthermia1, 2

Increased salivation2

Retained foetal membrane3

Injection site infection4

1 Transient and not detrimental to the animal.

2 Disappear within one hour.

3 If used for induction of parturition and depending on the time of use of the veterinary medicinal product

4 May become generalised and be serious. Please refer to section 3.5 (special precautions for safe use in the target species).

Pigs:

Common (1 to 10 animals / 100 animals treated):

Nesting1

Very rare (<1 to 1 animal / 10,000 animals Treated, including isolated reports):

Hyperthermia2

Injection site pain2

Increased respiratory rate2, dyspnoea2

Increased salivation2, stimulation of defecation 2, abdominal muscle spasms2, vomiting2

Frequent urination2

Reddening of the skin2

Ataxia2,3

Anaphylactic-type reaction

Hyperactivity4

Pruritus

1 Nesting is a normal behaviour 5 to 10 minutes after prostaglandin administration in sows that are housed in pen or pasture.

2 Transient: these effects are usually seen within 10 minutes of injection and disappear within 3 hours. They tend to parallel the signs exhibited by sows prior to normal parturition, only they appear to be condensed in time.

3 Slight

4 Such as restlessness-arching of back, pawing, rubbing and gnawing the crate

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:

Localised post injection bacterial infections that may become generalised have been reported. 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 post injection bacterial infections. Do not administer by intravenous route.

Induction of abortion or parturition by using exogenous substances may increase the risk for dystocia, fetal mortality, retention of the placenta and/or metritis.

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

Prostaglandins of the PGF2α type 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.

Accidental spillage on the skin, or accidental eye contact should be washed off immediately with clean water.

Impervious gloves should be worn to avoid skin contact.

Accidental injection may be a particular hazard to women who are pregnant, intending to become pregnant, or whose pregnancy status is unknown and to asthmatics and persons with bronchial or other respiratory problems.

Asthmatics and persons with bronchial or other respiratory problems should handle the veterinary medicinal product with care to avoid accidental self-injection and skin contact.

Pregnant women, women of child-bearing age, asthmatics and persons with bronchial and other respiratory problems should not use the veterinary product or should wear disposable plastic gloves.

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 and lactation:

Pregnancy status should be determined prior to injection since dinoprost has been demonstrated to result in abortion or parturition induction when administered at sufficiently high doses in many animal species.

If pregnant, the unlikely possibility of uterine rupture should be borne in mind, especially if cervical dilation does not occur.

Induction of parturition in pigs earlier than 72 hours prior to predicted farrowing date may result in reduced piglet viability.

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Interactions

As non-steroidal anti-inflammatory drugs may inhibit the endogenous prostaglandin synthesis, concomitant administration of these compounds with the product may decrease the luteolytic effects.

As oxytocics stimulate the production of prostaglandins, concomitant administration of these compounds with the veterinary medicinal product, may exacerbate the luteolytic effects.

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Overdose

Increased rectal temperature and a slight transitory increase in heart rate can be observed at 5 or 10 times the recommended dosage in cows and heifers.

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Special warnings

The veterinary medicinal product is ineffective when administered prior to day 5 after ovulation.

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Withdrawal period

Cattle:

Meat and offal: 2 days

Milk: Zero hours

Pigs:

Meat and offal: 2 days

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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

Nature of immediate packaging:

Type I colourless glass vials

Red chlorobutyl rubber stoppers

Aluminium overseals

Pack sizes:

Carboard box of 10 vials of 5 ml

Cardboard box of 5 vials of 10 ml

Cardboard box of 1 vial of 30 ml

Cardboard box of 1 vial of 50 ml

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions. After first broaching the vial, do not store above 25 °C.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale in 5 ml vials: 2 years.

Shelf-life of the veterinary medicinal product as packaged for sale in 10, 30 or 50 ml vials: 3 years.

Shelf-life after first broaching the vial: 14 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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 14966/3036 (NI)

Vm 14966/5037 (GB)

8 DATE OF FIRST AUTHORISATION

08 January 2001

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

October 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

Ceva Sante Animale

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