Cattle: cows, heifers.

Pigs: sows, gilts.

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

Cattle:

The luteolytic effect of the 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 persistent 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.

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 known hypersensitivity to the active substance or to any of the excipients.

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

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.

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 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 product or should wear disposable plastic gloves

Cattle:

Increased rectal temperature (hyperthermia) has been reported very rarely. However, rectal temperature changes have been transient in all cases observed and have not been detrimental to the animal. Limited salivation has been seen in some instances. The side-effects disappear within one hour after the administration of PGF2α. In cattle, if used for induction of parturition, retained foetal membranes may occur more frequently, depending on the time of use of the product.

Pigs:

Transient side-effects consisting of increased body temperature, signs of pain at the site of injection, increased respiratory rate, increased salivation, stimulation of defecation and urination, flushing of skin, dyspnea, slight ataxia, abdominal muscle spasms and vomiting occur occasionally following the administration of dinoprost in pregnant sows and gilts. These effects tend to parallel the signs exhibited by sows prior to normal parturition, only they appear to be condensed in time. These effects are usually seen within 10 minutes of injection and disappear within 3 hours. Nest building is a common behaviour 5 to 10 minutes after the administration of prostaglandin in sows that are housed in pen or pasture. In very rare occasions, anaphylactic-type reactions, hyperactivity (restlessness – arching of back, pawing, and rubbing and gnawing the crate) and pruritus have been reported.

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.

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 product, may exacerbate the luteolytic effects.

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.

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.

Cattle:

Meat and offal: 2 days

Milk: Zero hours

Pigs:

Meat and offal: 2 days